Personalised asthma action plans for adults with asthma

  • Review
  • Intervention

Authors


Abstract

Background

A key aim of asthma care is to empower each person to take control of his or her own condition. A personalised asthma action plan (PAAP), also known as a written action plan, an individualised action plan, or a self-management action plan, contributes to this endeavour. A PAAP includes individualised self-management instructions devised collaboratively with the patient to help maintain asthma control and regain control in the event of an exacerbation. A PAAP includes baseline characteristics (such as lung function), maintenance medication and instructions on how to respond to increasing symptoms and when to seek medical help.

Objectives

To evaluate the effectiveness of PAAPs used alone or in combination with education, for patient-reported outcomes, resource use and safety among adults with asthma.

Search methods

We searched the Cochrane Airways Group Specialised Register of trials, clinical trial registers, reference lists of included studies and review articles, and relevant manufacturers’ websites up to 14 September 2016.

Selection criteria

We included parallel randomised controlled trials (RCTs), both blinded and unblinded, that evaluated written PAAPs in adults with asthma. Included studies compared PAAP alone versus no PAAP, and/or PAAP plus education versus education alone.

Data collection and analysis

Two review authors independently extracted study characteristics and outcome data and assessed risk of bias for each included study. Primary outcomes were number of participants reporting at least one exacerbation requiring an emergency department (ED) visit or hospitalisation, asthma symptom scores on a validated scale and adverse events (all causes). Secondary outcomes were quality of life measured on a validated scale, number of participants reporting at least one exacerbation requiring systemic corticosteroids, respiratory function and days lost from work or study. We used a random-effects model for all analyses and standard Cochrane methods throughout.

Main results

We identified 15 studies described in 27 articles that met our inclusion criteria. These 15 included studies randomised a total of 3062 participants (PAAP vs no PAAP: 2602 participants; PAAP plus education vs education alone: 460 participants). Ten studies (eight PAAP vs no PAAP; two PAAP plus education vs education alone) provided outcome data that contributed to quantitative analyses. The overall quality of evidence was rated as low or very low.

Fourteen studies lasted six months or longer, and the remaining study lasted for 14 weeks. When reported, mean age ranged from 22 to 49 years and asthma severity ranged from mild to severe/high risk.

PAAP alone compared with no PAAP

Results showed no clear benefit or harm associated with PAAPs in terms of the number of participants requiring an ED visit or hospitalisation for an exacerbation (odds ratio (OR) 0.75, 95% confidence interval (CI) 0.45 to 1.24; 1385 participants; five studies; low-quality evidence), change from baseline in asthma symptoms (mean difference (MD) -0.16, 95% CI -0.25 to - 0.07; 141 participants; one study; low-quality evidence) or the number of serious adverse events, including death (OR 3.26, 95% CI 0.33 to 32.21; 125 participants; one study; very low-quality evidence). Data revealed a statistically significant improvement in quality of life scores for those receiving PAAP compared with no PAAP (MD 0.18, 95% CI 0.05 to 0.30; 441 participants; three studies; low-quality evidence), but this was below the threshold for a minimum clinically important difference (MCID). Results also showed no clear benefit or harm associated with PAAPs on the number of participants reporting at least one exacerbation requiring oral corticosteroids (OR 1.45, 95% CI 0.84 to 2.48; 1136 participants; three studies; very low-quality evidence) nor on respiratory function (change from baseline forced expiratory volume in one second (FEV1): MD -0.04 L, 95% CI -0.25L to 0.17 L; 392 participants; three studies; low-quality evidence). In one study, PAAPs were associated with significantly fewer days lost from work or study (MD -6.20, 95% CI -7.32 to - 5.08; 74 participants; low-quality evidence).

PAAP plus education compared with education alone

Results showed no clear benefit or harm associated with adding a PAAP to education in terms of the number of participants requiring an ED visit or hospitalisation for an exacerbation (OR 1.08, 95% CI 0.27 to 4.32; 70 participants; one study; very low-quality evidence), change from baseline in asthma symptoms (MD -0.10, 95% CI -0.54 to 0.34; 70 participants; one study; low-quality evidence), change in quality of life scores from baseline (MD 0.13, 95% CI -0.13 to 0.39; 174 participants; one study; low-quality evidence) and number of participants requiring oral corticosteroids for an exacerbation (OR 0.28, 95% CI 0.07 to 1.12; 70 participants; one study; very low-quality evidence). No studies reported serious adverse events, respiratory function or days lost from work or study.

Authors' conclusions

Analysis of available studies was limited by variable reporting of primary and secondary outcomes; therefore, it is difficult to draw firm conclusions related to the effectiveness of PAAPs in the management of adult asthma. We found no evidence from randomised controlled trials of additional benefit or harm associated with use of PAAP versus no PAAP, or PAAP plus education versus education alone, but we considered the quality of the evidence to be low or very low, meaning that we cannot be confident in the magnitude or direction of reported treatment effects. In the context of this caveat, we found no observable effect on the primary outcomes of hospital attendance with an asthma exacerbation, asthma symptom scores or adverse events. We recommend further research with a particular focus on key patient-relevant outcomes, including exacerbation frequency and quality of life, in a broad spectrum of adults, including those over 60 years of age.

Résumé scientifique

Les plans d'action personnalisés sous format écrit pour les adultes asthmatiques

Contexte

Un objectif clé de la prise en charge de l'asthme consiste à responsabiliser chaque personne en lui permettant de gérer son affection. Un plan d'action personnalisé contre l'asthme (PAPCA), également connu sous le nom de plan d'action sous format écrit, de plan d'action individualisé, ou de plan d'action d'autogestion, contribue à cet objectif. Un PAPCA contient des instructions individualisées d'autogestion élaborées en collaboration avec le patient pour l'aider à maintenir le contrôle de son asthme et à reprendre le contrôle en cas d'exacerbation. Un PAPCA contient des caractéristiques initiales (telles que la fonction pulmonaire), les médicaments d'entretien et des instructions sur la manière de faire face à des symptômes s'aggravant et à quel moment rechercher une aide médicale.

Objectifs

Évaluer l'efficacité des PAPCA utilisés seuls ou en association à une éducation au niveau de leur innocuité, des résultats rapportés par les patients et de l'utilisation des ressources chez les adultes asthmatiques.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre spécialisé des essais du groupe Cochrane sur les Voies respiratoires, dans des registres d'essais cliniques et dans les références bibliographiques des études incluses et des articles de revue pertinents, et sur les sites Internet des fabricants jusqu'au 14 septembre 2016.

Critères de sélection

Nous avons inclus les essais contrôlés randomisés (ECR), à la fois avec ou sans mise en aveugle, évaluant les PAPCA sous format écrit offerts à des adultes asthmatiques. Les études incluses comparaient les PAPCA seuls par rapport à l'absence de PAPCA, et/ou les PAPCA associés à une éducation par rapport à une éducation seulement.

Recueil et analyse des données

Deux auteurs de la revue ont indépendamment extrait les caractéristiques des études et les données de résultats et évalué le risque de biais pour chaque étude incluse. Les critères de jugement principaux étaient le nombre de participants rapportant au moins une exacerbation exigeant une visite aux urgences (SU) ou une hospitalisation, les scores d'évaluation des symptômes de l'asthme sur une échelle homologuée et les événements indésirables (toutes causes). Les critères de jugement secondaires étaient la qualité de vie mesurée sur une échelle homologuée, le nombre de participants rapportant au moins une exacerbation nécessitant des corticostéroïdes systémiques, la fonction respiratoire et le nombre de jours de travail ou d'étude perdus. Nous avons utilisé un modèle à effets aléatoires pour toutes les analyses et suivi les méthodes Cochrane standard tout au long de l'étude.

Résultats principaux

Nous avons identifié 15 études décrites dans 27 articles remplissant nos critères d'inclusion. Ces 15 études incluses ont randomisé un total de 3062 participants (PAPCA vs absence de PAPCA : 2602 participants ; PAPCA associé à une éducation versus éducation seulement : 460 participants). Dix études (huit PAPCA vs absence de PAPCA ; deux PAPCA associés à une éducation versus éducation seulement) ont fourni des données de résultats ayant contribué aux analyses quantitatives. La qualité globale des preuves était faible ou très faible.

Quatorze études ont duré six mois ou plus, et la dernière étude a duré 14 semaines. Lorsque cette information était rapportée, l'âge moyen variait de 22 à 49 ans et la gravité de l'asthme variait d'une gravité légère à une gravité sévère.

Les PAPCA seuls par rapport à l'absence de PAPCA

Les résultats n'ont montré aucun bénéfice ou danger évident associé aux PAPCA en termes de nombre de participants nécessitant un séjour en SU ou une hospitalisation pour une exacerbation (rapport des cotes (RC) 0,75, intervalle de confiance à 95 % (IC) 0,45 à 1,24 ; 1385 participants ; cinq études ; preuves de faible qualité), de changement par rapport aux valeurs à l'inclusion dans les symptômes de l'asthme (différence moyenne (DM) -0,16, IC à 95 % -0,25 à -0,07 ; 141 participants ; une étude ; preuves de faible qualité) ou de nombre d'événements indésirables graves, y compris les décès (RC 3,26, IC à 95 % 0,33 à 32,21 ; 125 participants ; une étude ; preuves de très faible qualité). Les données ont révélé une amélioration statistiquement significative dans les scores de qualité de vie chez les personnes recevant un PAPCA par rapport à l'absence de PAPCA (DM 0,18, IC à 95 % 0,05 à 0,30 ; 441 participants ; trois études ; preuves de faible qualité), mais cette différence était inférieure au seuil pour une différence cliniquement importante minime (DCIM). Les résultats n'ont également montré aucun bénéfice ou risque notable associé aux PAPCA sur le nombre de participants rapportant au moins une exacerbation nécessitant des corticoïdes oraux (RC 1,45, IC à 95 % 0,84 à 2,48 ; 1136 participants ; trois études ; preuves de très faible qualité), ou sur la fonction respiratoire (changement du volume expiratoire maximal en une seconde par rapport aux valeurs à l'inclusion (VEMS) : DM -0,04 l, IC à 95 % -0,25 L à 0,17 L ; 392 participants ; trois études ; preuves de faible qualité). Dans une étude, les PAPCA étaient associés à une diminution significative du nombre de jours de travail ou d'étude perdus (DM -6,20, IC à 95 % -7,32 à -5,08 ; 74 participants ; preuves de faible qualité).

Les PAPCA associés à une éducation par rapport à l'éducation seule

Les résultats n'ont montré aucun bénéfice ou préjudice évident associé à l'ajout d'un PAPCA à l'éducation en termes de nombre de participants nécessitant un séjour en SU ou une hospitalisation pour une exacerbation (RC 1,08, IC à 95 % 0,27 à 4,32 ; 70 participants ; une étude ; preuves de très faible qualité), de changement par rapport aux valeurs à l'inclusion dans les symptômes de l'asthme (DM -0,10, IC à 95 % -0,54 à 0,34 ; 70 participants ; une étude ; preuves de faible qualité), de modification des scores de qualité de vie par rapport aux valeurs à l'inclusion (DM 0,13, IC à 95 % -0,13 à 0,39 ; 174 participants ; une étude ; preuves de faible qualité) et de nombre de participants nécessitant des corticoïdes oraux pour une exacerbation (RC 0,28, IC à 95 % 0,07 à 1,12 ; 70 participants ; une étude ; preuves de très faible qualité). Aucune étude n'a rapporté les événements indésirables graves, la fonction respiratoire ou le nombre de jours de travail ou d'étude perdus.

Conclusions des auteurs

L'analyse des études disponibles était limitée par des comptes-rendus variables des critères de jugement primaires et secondaires ; par conséquent, il est difficile de tirer des conclusions définitives concernant l'efficacité des PAPCA dans la prise en charge de l'asthme chez l'adulte. Nous n'avons trouvé aucune preuve issue d'essais contrôlés randomisés indiquant un bénéfice supplémentaire ou des risques associés à l'utilisation de PAPCA par rapport à l'absence de PAPCA ou les PAPCA associés à une éducation par rapport à l'éducation seule, mais nous avons estimé que la qualité des preuves était faible ou très faible, ce qui signifie que nous ne pouvons pas être sûrs de l'ampleur ou de la direction des effets du traitement rapportés. Dans le contexte de cette réserve, nous n'avons trouvé aucun effet notable sur les critères de jugement principaux des visites à l'hôpital pour les exacerbations de l'asthme, sur les scores d'évaluation des symptômes de l'asthme ou sur les événements indésirables. Nous recommandons de réaliser d'autres recherches en portant une attention particulière aux principaux critères de jugement relatifs aux patients tels que la fréquence des crises et la qualité de vie, avec un large éventail d'adultes, y compris ceux âgés de plus de 60 ans.

Resumen

Planes de acción personalizados para pacientes adultos con asma

Antecedentes

Un objetivo clave en la atención del asma es facultar a cada paciente a tomar el control de su enfermedad. Un plan de acción personalizado para el asma (PAPA), también conocido como plan de acción escrito, plan de acción individualizado o plan de acción para el autocuidado, contribuye a este cometido. El PAPA incluye instrucciones individualizadas para el autocuidado, creadas de forma colaborativa con el paciente para ayudar a mantener el control del asma y recuperar el control en caso de una exacerbación. El PAPA incluye las características iniciales (como el funcionamiento pulmonar), la medicación de mantenimiento y las instrucciones sobre cómo responder al aumento de los síntomas y cuándo solicitar ayuda médica.

Objetivos

Evaluar la efectividad de los PAPA utilizados solos o en combinación con educación, con respecto a los resultados informados por el paciente, el uso de los recursos y la seguridad en pacientes adultos con asma.

Métodos de búsqueda

Se realizaron búsquedas en el registro especializado de ensayos del Grupo Cochrane de Vías Respiratorias (Cochrane Airways Group), registros de ensayos clínicos, listas de referencias de estudios incluidos, en artículos de revisión y en sitios web de fabricantes relevantes hasta el 14 de septiembre de 2016.

Criterios de selección

Se incluyeron los ensayos controlados aleatorios (ECA) paralelos, cegados y no cegados, que evaluaron PAPA escritos en pacientes adultos con asma. Los estudios incluidos compararon PAPA solo versus ningún PAPA, o PAPA más educación versus educación sola.

Obtención y análisis de los datos

Dos autores de la revisión extrajeron de forma independiente las características de los estudios, los datos de resultados y evaluaron el riesgo de sesgo para cada estudio incluido. Los resultados primarios fueron número de participantes que informaron al menos una exacerbación que requirió una consulta al servicio de urgencias (SU) u hospitalización, puntuaciones de los síntomas del asma en una escala validada y eventos adversos (todas las causas). Los resultados secundarios fueron calidad de vida medida en una escala validada, número de participantes que informaron al menos una exacerbación que requirió corticosteroides sistémicos, función respiratoria y días de ausencia al trabajo o al estudio. Se utilizó un modelo de efectos aleatorios para todos los análisis y los métodos Cochrane estándar desde el principio hasta el final.

Resultados principales

Se identificaron 15 estudios descritos en 27 artículos que cumplieron los criterios de inclusión. Estos 15 estudios incluidos asignaron al azar a un total de 3062 participantes (PAPA versus ningún PAPA: 2602 participantes; PAPA más educación versus educación sola: 460 participantes). Diez estudios (ocho PAPA versus ningún PAPA; dos PAPA más educación versus educación sola) proporcionaron datos de resultado que contribuyeron a los análisis cuantitativos. La calidad general de la evidencia se calificó como baja o muy baja.

Catorce estudios duraron seis meses o más, y el estudio restante duró 14 semanas. Cuando se informaron, la media de la edad varió de 22 a 49 años y la gravedad del asma varió de riesgo leve a grave/alto.

PAPA solo en comparación con ningún PAPA

Los resultados no mostraron efectos beneficiosos ni perjudiciales claros asociados con los PAPA con respecto al número de participantes que requirieron una consulta al SU u hospitalización por una exacerbación (odds ratio [OR] 0,75; intervalo de confianza [IC] del 95%: 0,45 a 1,24; 1385 participantes; cinco estudios; evidencia de baja calidad), cambio a partir del inicio en los síntomas del asma (diferencia de medias [DM] -0,16; IC del 95%: -0,25 a - 0,07; 141 participantes; un estudio; evidencia de baja calidad) ni en el número de eventos adversos graves, que incluye la muerte (OR 3,26; IC del 95%: 0,33 a 32,21; 125 participantes; un estudio; evidencia de muy baja calidad). Los datos mostraron una mejoría estadísticamente significativa en las puntuaciones de calidad de vida en los pacientes que recibieron PAPA en comparación con ningún PAPA (DM 0,18; IC del 95%: 0,05 a 0,30; 441 participantes; tres estudios; evidencia de baja calidad), pero este resultado estuvo por debajo del umbral para una diferencia mínima clínicamente importante (DMCI). Los resultados tampoco mostraron efectos beneficiosos ni perjudiciales claros asociados con los PAPA en el número de participantes que informaron al menos una exacerbación que requirió corticosteroides orales (OR 1,45; IC del 95%: 0,84 a 2,48; 1136 participantes; tres estudios; evidencia de muy baja calidad) ni sobre la función respiratoria (cambio a partir del inicio en el volumen espiratorio forzado en un segundo [VEF1]: DM -0,04 l; IC del 95%: -0,25 a 0,17; 392 participantes; tres estudios; evidencia de baja calidad). En un estudio, los PAPA se asociaron con significativamente menos días de ausencia al trabajo o al estudio (DM -6,20; IC del 95%: -7,32 a -5,08; 74 participantes; evidencia de baja calidad).

PAPA más educación en comparación con educación sola

Los resultados no mostraron efectos beneficiosos ni perjudiciales claros asociados con agregar un PAPA a la educación con respecto al número de participantes que requirieron una consulta al SU u hospitalización por una exacerbación (OR 1,08; IC del 95%: 0,27 a 4,32; 70 participantes; un estudio; evidencia de muy baja calidad), cambio a partir del inicio en los síntomas del asma (DM -0,10; IC del 95%: -0,54 a 0,34; 70 participantes; un estudio; evidencia de baja calidad), cambio en las puntuaciones de calidad de vida a partir del inicio (DM 0,13; IC del 95%: -0,13 a 0,39; 174 participantes; un estudio; evidencia de baja calidad) ni en el número de participantes que requirieron corticosteroides orales por una exacerbación (OR 0,28; IC del 95%: 0,07 a 1,12; 70 participantes; un estudio; evidencia de muy baja calidad). Ningún estudio informó eventos adversos graves, función respiratoria ni días de ausencia al trabajo o al estudio.

Conclusiones de los autores

El análisis de los estudios disponibles fue limitado debido al informe variable de los resultados primarios y secundarios; por lo tanto, es difícil establecer conclusiones firmes relacionadas con la efectividad de los PAPA en el tratamiento del asma en los pacientes adultos. No se encontró evidencia a partir de ensayos controlados aleatorios de efectos beneficiosos ni perjudiciales adicionales asociados con el uso de PAPA versus ningún PAPA, o PAPA más educación versus educación sola, pero se consideró que la calidad de la evidencia fue baja o muy baja, lo que significa que no es posible tener seguridad con respecto a la magnitud ni a la dirección de los efectos del tratamiento informados. En el contexto de esta advertencia, no se encontraron efectos observables sobre los resultados primarios consulta hospitalaria con una exacerbación del asma, puntuaciones de los síntomas del asma ni eventos adversos. Se recomienda realizar estudios de investigación adicionales, con énfasis particular en resultados clave relevantes para el paciente que incluyen frecuencia de la exacerbación y calidad de vida, en un espectro amplio de pacientes adultos que incluya los mayores de 60 años de edad.

Plain language summary

Written and personalised action plans to help adults manage their asthma

Review question

People with asthma may be given a written personalised action plan for managing their asthma. This plan provides information on which medicines they should take and when. Other people may be given education on how they should look after their asthma. This review set out to see if using a plan on its own or with education helps improve outcomes for people with asthma.

Background

Asthma is a disease that affects the lungs, which can make it difficult for people to breathe. Some people can manage their asthma very well, and it does not affect them very much, but for other people, asthma can change and sometimes can get worse very quickly and often. When this happens, people may go to see their doctor or may go to the hospital. When their asthma gets worse, people can take medicines or can change the amount of medicine they take to make their asthma better. To know when and how they should change their medicines, adults with asthma can be given a written plan that is designed just for them. This is called a personalised asthma action plan (PAAP). The PAAP will tell people when they need to see their doctor and may include education on how they should manage their asthma.

Study characteristics

We searched for studies up to September 2016. We found 15 studies that provided the information we were looking for in conducting this review. A total of 3062 people had taken part in these studies; 2602 people took part in 11 studies looking at PAAP versus no PAAP, and 460 people were included in four studies looking at PAAP and education versus just education. Fourteen studies lasted six months or longer. The average age of people in these studies ranged from 22 to 49 years. Asthma severity ranged from mild to severe. We were able to use data from 10 of these 15 studies to inform our findings.

Key results

PAAP alone compared with no PAAP: People using a PAAP did not show any difference (good or bad) in terms of having to go to the hospital because their asthma worsened compared with people not using a PAAP. This result was the same for changes in asthma symptom scores and number of deaths due to asthma. People with a PAAP showed no improvement in their quality of life compared with those without a PAAP, but the difference was not large enough to be meaningful.

PAAP plus education compared with education alone: Review authors found no real difference - good or bad - between people using a PAAP and education and those just receiving education. This finding was the same for all outcomes, that is, having to go to the hospital because their asthma worsened and changes in symptom scores and quality of life.

Quality of the evidence

We rated the quality of the 15 included studies as low or very low because the few studies included in this review had problems with study design, including how to enrol people into the study and how to handle missing data for some people. Also, studies had problems with how outcome data for those who did not finish the study should be managed. This means that as future studies are completed and added to future versions of this review, the findings of the review may change.

Ringkasan bahasa mudah

Pelan tindakan peribadi dan bertulis untuk membantu orang dewasa menguruskan asma mereka.

Soalan ulasan

Orang yang menghidap asma boleh diiberi pelan tindakan peribadi bertulis untuk menguruskan asma mereka.Pelan ini menyediakan maklumat tentang ubat mana yang patut diambil dan bila.Orang lain mungkin boleh diberi pengetahuan tentang bagaimana menjaga asma mereka.Ulasan ini meninjau sama ada penggunaan pelan sahaja atau dengan pendidikan membantu menambah baik hasil untuk orang yang menghidap penyakit asma.

Latar belakang

Asma adalah penyakit yang mempengaruhi paru-paru, yang boleh menyukarkan orang untuk bernafas.Sesetengah orang boleh menguruskan asma mereka dengan baik, dan ia tidak banyak mengganggu, tetapi bagi sesetengah orang asma boleh berubah menjadi lebih teruk dan kerap.Apabila ini terjadi, mereka mungkin pergi berjumpa doktor atau pergi ke hospital.Apabila asma menjadi lebih teruk, mereka boleh mengambil ubat atau mengubah amaun ubat untuk diambil bagi menambah baik asma mereka.Untuk mengetahui bila dan bagaimana untuk mengubah ubat, orang dewasa dengan asma boleh diberi pelan bertulis yang direka khas untuk mereka.Ini dipanggil pelan tindakan asma peribadi (PAAP).PAAP akan memberitahu orang bila mereka perlu berjumpa doktor dan mungkin termasuk pendidikan bagaimana untuk mengurus asma mereka.

Ciri kajian

Kami mencari kajian-kajian sehingga September 2016.Kami mendapati 15 kajian yang memberi maklumat yang kami cari dalam membuat ulasan ini.Sejumlah 3062 orang telah mengambil bahagian dalam kajian-kajian tersebut; 2602 mengambil bahagian dalam 11 kajian yang melihat PAAP berbanding tiada PAAP, dan 460 orang dimasukkan ke dalam empat kajian yang melihat PAAP dan pendidikan berbanding hanya pendidikan.Empat belas kajian berlangsung selama enam bulan atau lebih.Purata umur peserta kajian adalah di antara 22 hingga 49 tahun.Keterukan asma adalah di antara ringan hingga teruk.Kami menggunakan data daripada 10 dari 15 kajian untuk mengesahkan dapatan kami.

Keputusan utama

PAAP sahaja berbanding tanpa PAAP: Orang yang mennggunakan PAAP tidak menunjukkan perbezaan (baik atau buruk) dari sudut terpaksa pergi ke hospital kerana asma mereka menjadi teruk berbanding dengan orang yang tidak menggunakan PAAP.Keputusan ini sama untuk perubahan dalam gejala asma dan bilangan kematian akibat asma.Orang dengan PAAP menunjukkan tiada penambahbaikan dalam kualiti hidup berbanding dengan mereka yang tanpa PAAP, namun perbezaan ini tidak cukup besar untuk memberi sebarang makna.

PAAP dengan pendidikan berbanding dengan pendidikan sahaja: Penulis ulasan tidak mendapati perbezaan - baik atau buruk - di antara orang yang menggunakan PAAP dan pendidikan dengan mereka yang menerima pendidikan sahaja.Dapatan ini adalah sama untuk semua hasil, iaitu terpaksa pergi ke hospital sebab asma menjadi lebih teruk dan perubahan-perubahan dalam skor gejala dan kualiti hidup.

Kualiti bukti

Kami menilai kualiti 15 kajian yang dimasukkan sebagai rendah atau sangat rendah kerana bilangan kecil kajian yang dimasukkan dalam ulasan ini mempunyai masalah reka bentuk kajian, termasuk bagaimana memasukkan peserta ke dalam kajian dan bagaimana menangani data tidak lengkap untuk sesetengah orang.Kajian-kajian juga bermasalah dengan data hasil bagi mengurus mereka yang tidak menamatkan kajian. Ini bermaksud jika kajian lanjutan yang lengkap ditambah kepada versi lanjutan ulasan ini, dapatan ulasan boleh berubah.

Catatan terjemahan

Diterjemahkan oleh Noorliza Mastura Ismail (Kolej Perubatan Melaka-Manipal). Disunting oleh Tuan Hairulnizam Tuan Kamauzaman (Universiti Sains Malaysia). Untuk sebarang pertanyaan berkaitan terjemahan ini, sila hubungi noorliza.mastura@manipal.edu.my

Laički sažetak

Pisani i personalizirani akcijski planovi koji pomažu odraslima u liječenju astme

Istraživačko pitanje

Osobe s astmom mogu dobiti pisani personalizirani akcijski plan za liječenje astme. Plan pruža informacije o tome koje lijekove treba uzeti i kada. Ostale ljude se može educirati o tome kako treba paziti na astmu. Ovaj pregled je pokazao pomaže li uporaba plana, samostalno ili s edukacijom, u poboljšanju ishoda astme u osoba koje od nje boluju.

Dosadašnje spoznaje

Astma je bolest koja utječe na pluća, što može otežati disanje. Neki ljudi dobro kontroliraju svoju astmu i ona ne utječe bitno na njih, ali u drugih se ljudi astma može promijeniti, tako da se kadšto i vrlo brzo i često pogoršava. Kada se to dogodi, bolesnici mogu otići svojem liječniku ili u bolnicu. Također, kada se astma pogorša, bolesnici mogu uzimati lijekove ili mogu promijeniti količinu lijeka koji uzimaju da bi im se simptomi astme ublažili. Da bi znali kada i kako trebaju promijeniti svoje lijekove, odrasle osobe s astmom mogu dobiti pisani plan koji je pripremljen samo za njih. To se zove personalizirani akcijski plan za astmu (PAAP). PAAP će informirati bolesnike kada trebaju posjetiti svojega liječnika i može uključivati edukaciju o tome kako bi trebali liječiti svoju astmu.

Obilježja uključenih istraživanja

Tražili smo studije objavljene do rujna 2016. Pronašli smo 15 studija koje su pružile informacije koje smo tražili u izradi ovoga pregleda. Ukupno je 3062 ljudi sudjelovalo u tim studijama; 2602 ljudi je sudjelovalo u 11 studija koje su pratile učinke PAAP-a u odnosu na stanje bolesnika bez PAAP-a; 460 ljudi uključeno je u četiri studije koje su pratile PAAP i edukaciju u usporedbi sa samom edukacijom. Četrnaest studija trajalo je šest mjeseci ili dulje. Prosječna dob ispitanika kretala se od 22 do 49 godina. Stupanj astme se kretao od blage do teške. Bili smo u mogućnosti koristiti podatke iz 10 od tih 15 studija kao relevantne.

Ključni rezultati

PAAP u usporedbi s postupcima bez PAAP-a: u usporedbi s osobama koje nisu koristile PAAP, osobe koje jesu koristile PAAP nisu pokazale nikakve razlike (dobre ili loše) u smislu da moraju otići u bolnicu jer im se astma pogoršala. Taj rezultat je bio isti za promjene u simptomima astme i broju smrti zbog astme. Osobe s PAAP-om nisu pokazale poboljšanje kvalitete života u usporedbi s onima bez PAAP-a, ali razlika nije bila dovoljno velika da bi imala smisla.

PAAP i edukacija u usporedbi sa samom edukacijom: autori Cochrane sustavnog pregleda nisu pronašli razlike - povoljne ili nepovoljne - između ljudi koji su koristili PAAP i edukaciju i onih koji su dobili samo edukaciju. Taj je nalaz bio isti za sve ishode, tj. ljudi su morali otići u bolnicu jer im se astma pogoršala kao i zbog promjene u simptomima i kvaliteti života.

Kvaliteta dokaza

Kvaliteta 15 uključenih studija ocijenjena je kao niska ili vrlo niska, jer je nekoliko studija uključenih u ovaj pregled imalo problema s ustrojem studije, uključujući način upisivanja ljudi u studiju i postupanje s podatcima koji nedostaju za neke ispitanike. Isto tako, neke su studije imale problema s time kako bi se upravljalo podatcima o ishodu onih bolesnika koji nisu završili studiju. To znači da se, kad budući rezultati budu dovršeni i dodani novim inačicama ovog Cochrane sustavnoga pregleda, sadašnji rezultati mogu promijeniti.

Bilješke prijevoda

Hrvatski Cochrane
Prevela: Adriana Bolić
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

Résumé simplifié

Les plans d'action personnalisés sous format écrit pour aider les adultes à gérer leur asthme

Question de la revue

Les personnes asthmatiques peuvent recevoir un plan d'action personnalisé sous format écrit pour la prise en charge de leur asthme. Ce plan fournit des informations sur les médicaments que ceux-ci doivent prendre et à quel moment il est approprié de les prendre. D'autres personnes peuvent recevoir une éducation sur la manière dont elles devraient prendre en charge leur asthme. Cette revue a cherché à déterminer si l'utilisation d'un plan seul ou associé à une formation permet d'améliorer les résultats pour les personnes asthmatiques.

Contexte

L'asthme est une maladie affectant les poumons et pouvant rendre la respiration difficile. Certaines personnes peuvent très bien gérer leur asthme, et celui-ci ne les affecte alors que très peu, mais pour d'autres personnes l'asthme peut changer et parfois s'aggraver très rapidement et de manière répétée. Dans ces situations, ces personnes peuvent consulter leur médecin ou être hospitalisées. Lorsque leur asthme s'aggrave, ces personnes peuvent prendre des médicaments ou modifier la quantité de médicament qu'elles prennent afin de mieux gérer leur asthme. Pour savoir à quel moment et de quelle manière ils devraient adapter leurs médicaments, les adultes asthmatiques peuvent recevoir un plan sous format écrit élaboré spécialement pour eux. C'est ce que l'on appelle un plan d'action personnalisé contre l'asthme (PAPCA). Le PAPCA indique à ces personnes quand elles doivent consulter leur médecin et il peut inclure des informations sur la manière dont elles devraient prendre en charge leur asthme.

Caractéristiques de l'étude

Nous avons recherché des études jusqu'à septembre 2016. Nous avons trouvé 15 études ayant fourni des informations pertinentes pour cette revue. Un total de 3062 personnes avaient pris part à ces études ; 2602 personnes ont participé à 11 études examinant les PAPCA par rapport à l'absence de PAPCA, et 460 personnes ont été incluses dans quatre études examinant les PAPCA associés à une éducation par rapport à l'éducation seulement. Quatorze études ont duré six mois ou plus. L'âge moyen des participants dans ces études variait de 22 à 49 ans. La gravité de l'asthme variait de légère à sévère. Nous n'avons pas pu utiliser les données de 10 de ces 15 études pour informer nos conclusions.

Résultats principaux

Les PAPCA seuls par rapport à l'absence de PAPCA : Il n'y avait aucune différence (positive ou négative) entre les personnes utilisant un PAPCA et celles n'utilisant pas de PAPCA en termes d'hospitalisations en raison d'une aggravation de l'asthme. Un résultat identique a été trouvé au niveau des changements dans les scores d'évaluation des symptômes de l'asthme et au niveau du nombre de décès liés à l'asthme. Il n'y avait pas d'amélioration de la qualité de vie pour les personnes ayant un PAPCA par rapport à celles sans PAPCA, mais la différence n'était pas suffisamment large pour être pertinente.

Les PAPCA associés à une éducation par rapport à l'éducation seule : Les auteurs de la revue n'ont trouvé aucune différence réelle - bonne ou mauvaise - entre les personnes utilisant un PAPCA et ayant reçu une éducation par rapport à celles recevant uniquement une éducation. Cette constatation était vraie pour tous les autres résultats, c'est-à-dire les hospitalisations en raison d'une aggravation de l'asthme et les changements au niveau des scores d'évaluation des symptômes et de la qualité de vie.

Qualité des preuves

Nous avons évalué la qualité des 15 études incluses comme étant faible ou très faible car les quelques études incluses dans cette revue présentaient des problèmes dans leur conception, notamment quant à la manière dont celles-ci ont recruté des participants et dans les stratégies de prise en compte des données manquantes pour certaines personnes. En outre, des études avaient des problèmes dans la manière dont elles ont géré les données de résultat pour les personnes ayant quitté prématurément les études. Cela signifie que, au fur et à mesure que de nouvelles études seront effectuées et ajoutées dans les futures versions de cette revue, les résultats de la revue pourraient changer.

Notes de traduction

Traduction réalisée par Martin Vuillème et révisée par Cochrane France

Resumen en términos sencillos

Planes de acción escritos y personalizados para ayudar a los pacientes adultos a controlar el asma

Pregunta de la revisión

A los pacientes con asma se les puede proporcionar un plan de acción personalizado escrito para controlar el asma. Este plan proporciona información sobre qué fármacos deben tomar y cuándo. Otros pacientes pueden recibir educación sobre cómo deben tratar el asma. Esta revisión tuvo como objetivo analizar si el uso de un plan por sí solo o con educación ayuda a mejorar los resultados de los pacientes con asma.

Antecedentes

El asma es una enfermedad que afecta a los pulmones y puede dificultar la respiración de los pacientes. Algunos pacientes pueden controlar el asma muy bien y no los afecta demasiado, pero en otros pacientes el asma puede cambiar y a veces puede empeorar muy rápidamente y con gran frecuencia. Cuando sucede lo anterior, los pacientes pueden acudir al médico o pueden ir al hospital. Cuando el asma empeora, los pacientes pueden tomar fármacos o pueden cambiar la cantidad de fármacos que utilizan para mejorar el asma. Para saber cuándo y cómo se deben cambiar los fármacos, a los pacientes adultos con asma se les puede dar un plan escrito diseñado solo para ellos. A este plan se le llama un plan de acción personalizado para el asma (PAPA). El PAPA dirá a los pacientes cuando necesitan ver al médico y puede incluir educación sobre cómo deben controlar el asma.

Características de los estudios

Se buscaron estudios hasta septiembre 2016. Se encontraron 15 estudios que proporcionaron la información que se estaba buscando al realizar esta revisión. Había participado un total de 3062 pacientes en estos estudios; 2602 pacientes participaron en 11 estudios que consideraron PAPA versus ningún PAPA, y 460 pacientes se incluyeron en cuatro estudios que analizaron PAPA y educación versus educación sola. Catorce estudios duraron seis meses o más. La edad promedio de los pacientes en estos estudios varió de 22 a 49 años. La gravedad del asma varió de moderada a grave. Se pudieron utilizar datos de 10 de estos 15 estudios para informar los hallazgos.

Resultados clave

: Los pacientes que utilizaron un PAPA no mostraron diferencias (buenas ni malas) con respecto a tener que ir al hospital por el empeoramiento del asma en comparación con los pacientes que no utilizaron un PAPA. Este resultado fue igual para los cambios en las puntuaciones de los síntomas del asma y el número de muertes debido al asma. Los pacientes con un PAPA no mostraron mejoría en la calidad de vida en comparación con los que no utilizaron un PAPA, pero la diferencia no fue suficientemente grande para ser significativa.

: Los autores de la revisión no encontraron una diferencia real (buena ni mala) entre los pacientes que utilizaron un PAPA y educación y los que recibieron educación sola. Este resultado fue igual en todos los resultados, o sea, tener que ir al hospital debido al empeoramiento del asma y cambios en las puntuaciones de los síntomas y de la calidad de vida.

Calidad de la evidencia

La calidad de los 15 estudios incluidos se consideró baja o muy baja porque los pocos estudios incluidos en esta revisión tuvieron problemas con el diseño, que incluyeron cómo se reclutaron a los pacientes en el estudio y cómo se procesaron los datos faltantes de algunos pacientes. Además, los estudios tuvieron problemas con respecto a cómo se debieron procesar los datos de resultado de los pacientes que no finalizaron el estudio. Esto significa que a medida que se completan los estudios futuros y se añaden a futuras versiones de esta revisión, los hallazgos de la revisión pueden cambiar.

Notas de traducción

La traducción y edición de las revisiones Cochrane han sido realizadas bajo la responsabilidad del Centro Cochrane Iberoamericano, gracias a la suscripción efectuada por el Ministerio de Sanidad, Servicios Sociales e Igualdad del Gobierno español. Si detecta algún problema con la traducción, por favor, contacte con Infoglobal Suport, cochrane@infoglobal-suport.com.

Summary of findings(Explanation)

Summary of findings for the main comparison. PAAP compared with no PAAP for adults with asthma
  1. aThe quality of the evidence was downgraded once for risk of bias (3/5 studies at risk of attrition bias and baseline imbalance in morbidity reported by Hoskins (weight 48.8%)) and once for imprecision (small number of total events; insufficient sample size (optimal size > 4 K) and CI including null effect and chance of appreciable benefit).

    bThe quality of the evidence was downgraded once for risk of bias (high risk of performance, detection and attrition bias) and once for indirectness (based on only one study, thus reducing generalisability).

    cThe quality of the evidence was downgraded once for risk of bias (attrition bias), once for imprecision (small number of events, insufficient sample size and CI including null effect and appreciable risk of harm) and once for indirectness (single study limiting generalisability).

    dThe quality of the evidence was downgraded twice for risk of bias (performance, detection and attrition bias).

    eThe quality of the evidence was downgraded twice for risk of bias (attrition bias and baseline imbalance in morbidity reported by Hoskins (weight 54.9%); high risk of other bias based on reporting error in Thoonen 2001) and once for imprecision (CI including null effect and chance of appreciable benefit).

    fThe quality of the evidence was downgraded once for risk of detection bias and attrition bias) and once for inconsistency (opposite direction of effect observed in one study; heterogeneity I2 = 51%).

    gThe quality of the evidence was downgraded twice for indirectness (single study limiting generalisability; study performed in tertiary care setting in Serbia).

PAAP compared with no PAAP for adults with asthma
Patient or population: adults with asthma
Setting: primary care, secondary care, tertiary care, community
Intervention: PAAP
Comparison: no PAAP
OutcomesAnticipated absolute effects* (95% CI)Relative effect
(95% CI)
Number of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Risk with no PAAPRisk with PAAP
Exacerbation requiring ED or hospitalisation.
Follow-up: range 14 weeks to 6 months.
82 per 1000.63 per 1000
(39 to 100)
OR 0.75
(0.45 to 1.24)
1385
(5 RCTs)
⊕⊕⊝⊝
LOWa
No clear benefit or harm of a PAAP (low-quality evidence).
Asthma control, change from baseline in ACQ.Mean asthma control, change from baseline in ACQ was -0.29.MD 0.16 lower
(0.25 lower to 0.07 lower)
-141
(1 RCT)
⊕⊕⊝⊝
LOWb
No clear benefit or harm of a PAAP (low-quality evidence); MCID for ACQ was 0.5.
Serious adverse events (including deaths).16 per 1000.49 per 1000
(5 to 538)
OR 3.26
(0.33 to 32.21)
125
(1 RCT)
⊕⊝⊝⊝
VERY LOWc
No clear benefit or harm of a PAAP (very low-quality evidence).
Quality of life, change from baseline in AQLQ.Mean quality of life, change from baseline in AQLQ ranged from 0.1 to 0.91.MD 0.18 higher
(0.05 higher to 0.3 higher)
-441
(3 RCTs)
⊕⊕⊝⊝
LOWd
Mean between-group difference in improvement from baseline did not exceed the minimum clinically important difference (0.5 for AQLQ) and is unlikely to be clinically relevant.
Exacerbation requiring OCS.306 per 1000.390 per 1000
(270 to 523)
OR 1.45
(0.84 to 2.48)
1136
(3 RCTs)
⊕⊝⊝⊝
VERY LOWe
No clear benefit or harm of a PAAP (low-quality evidence).
Lung function, change from baseline in FEV1 (L).Mean lung function, change from baseline in FEV1 (L) was 0 L.MD 0.04 L lower
(0.25 lower to 0.17 higher)
-392
(3 RCTs)
⊕⊕⊝⊝
LOWf
No clear benefit or harm of a PAAP (low-quality evidence).
Days lost from work or study.Mean days lost from work or study was 0.MD 6.2 lower
(7.32 lower to 5.08 lower)
-74
(1 RCT)
⊕⊕⊝⊝
LOWg
PAAP was associated with significantly fewer days lost from work or study.
*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

ACQ, Asthma Control Questionnaire; AQLQ, Asthma Quality of Life Questionnaire; CI, confidence interval; ED, emergency department; FEV1, forced expiratory volume in 1 second; GRADE, Grades of Recommendation, Assessment, Development and Evaluation Working Group; HR, hazard ratio; MCID, minimum clinically important difference; MD, mean difference; OCS, oral corticosteroid; OR, odds ratio; PAAP, personalised asthma action plan; RCT, randomised controlled trial; RR, risk ratio.
GRADE Working Group grades of evidence.
High quality: We are very confident that the true effect lies close to the estimate of effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

Summary of findings 2 PAAP plus education compared with education alone for adults with asthma

Summary of findings 2. PAAP plus education compared with education alone for adults with asthma
  1. aThe quality of the evidence was downgraded once for risk of bias ('other': Participants did not receive the intervention as planned), once for indirectness (single study reducing generalisability) and once for imprecision (CI including null effect and risk of appreciable harm or benefit).

    bThe quality of the evidence was downgraded once for risk of bias ('other': Participants did not receive the intervention as planned) and once for indirectness (single study reducing generalisability).

    cThe quality of the evidence was downgraded once for risk of bias (performance bias) and once for indirectness (single study reducing generalisability).

    dThe quality of the evidence was downgraded once for risk of bias ('other': Participants did not receive the intervention as planned), once for indirectness (single study reducing generalisability) and once for imprecision (CI including null effect and risk of appreciable benefit).

PAAP plus education compared with education alone for adults with asthma
Patient or population: adults with asthma
Setting: Community, secondary care, tertiary care
Intervention: PAAP plus education
Comparison: education alone
OutcomesAnticipated absolute effects* (95% CI)Relative effect
(95% CI)
Number of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Risk with education aloneRisk with PAAP plus education
Exacerbation requiring ED or hospitalisation.265 per 1000.280 per 1000
(89 to 609)
OR 1.08
(0.27 to 4.32)
70
(1 RCT)
⊕⊝⊝⊝
VERY LOWa
No clear benefit or harm of PAAP plus education (very low-quality evidence). Risk with education alone based on 12 months before study start.
Asthma control, change from baseline in ACQ score.Mean asthma control, change from baseline in ACQ score was -0.29.MD 0.1 lower
(0.54 lower to 0.34 higher)
-70
(1 RCT)
⊕⊕⊝⊝
LOWb
No clear benefit or harm of PAAP plus education (low-quality evidence). MCID for ACQ (0.5) not reached.
Serious adverse events (including death).Included studies reported no data for this outcome.
Quality of life, change from baseline in AQLQ score.Mean quality of life, change from baseline in AQLQ score was 0.3.MD 0.13 higher
(0.13 lower to 0.39 higher)
-174
(1 RCT)
⊕⊕⊝⊝
LOWc
No clear benefit or harm of PAAP plus education (low-quality evidence). MCID for AQLQ (0.5) not reached.
Exacerbation requiring OCS.324 per 1000.118 per 1000
(32 to 349)
OR 0.28
(0.07 to 1.12)

70

(1 RCT)

⊕⊝⊝⊝
VERY LOWd
No clear benefit or harm of PAAP plus education (very low-quality evidence). Risk with education alone based on 12 months before study start.
Lung function.Included studies reported no data for this outcome.
Days lost from work or study.Included studies reported no data for this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

ACQ, Asthma Control Questionnaire; AQLQ, Asthma Quality of Life Questionnaire; CI, confidence interval; ED, emergency department; GRADE, Grades of Recommendation, Assessment, Development and Evaluation Working Group; HR, hazard ratio; MCID, minimum clinically important difference; MD, mean difference; OCS, oral corticosteroid; OR, odds ratio; PAAP, personalised asthma action plan; RCT, randomised controlled trial; RR, risk ratio.
GRADE Working Group grades of evidence.
High quality: We are very confident that the true effect lies close to the estimate of effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

Background

Description of the condition

Asthma is a common respiratory condition characterised by airway inflammation and oedema, bronchoconstriction and airflow limitation. World Health Organization (WHO) estimates suggest that up to 334 million people are affected worldwide, with the majority of affected people living in low- and middle-income countries (Global Asthma Report 2014); the total burden may be greater than reported owing to the high prevalence of asthma in countries that lack adequate reporting mechanisms. The economic burden of asthma is considerable, with direct treatment costs and indirect costs of lost productivity among the highest for non-communicable diseases (Global Asthma Report 2014). Symptoms including cough and breathlessness may be intermittent or persistent (BTS/SIGN 2016). Triggers may be allergic (e.g. pollen, animal dander, dust mite) or non-allergic (e.g. exercise, smoking, cold air, smoke from fires in confined living spaces). The disease may be characterised by repeated exacerbations requiring a change to normal maintenance therapy. Treatment of people with asthma includes avoidance of potential triggers (when possible), use of inhaled corticosteroids (ICSs) and leukotriene receptor antagonists (LTRAs) to reduce airway inflammation and use of inhaled long-acting beta2-agonists (LABAs), short-acting beta2-agonists (SABAs) and anticholinergic bronchodilators (i.e. long-acting muscarinic antagonists (LAMAs)) to relieve airflow limitation (BTS/SIGN 2016; GINA 2016; NICE 2007; NICE 2013). Exacerbations may require the addition of oral or parenteral steroids. People with severe asthma may also benefit from immunomodulatory therapy targeted to key mediators of allergic airway inflammation, including immunoglobulin E (IgE) (Normansell 2014).

Goals of asthma treatment include total control of daytime and nocturnal symptoms, normal exercise and functional capacity and prevention of exacerbations (GINA 2016). It is clear from studies including the national review of UK asthma deaths (NRAD 2014) that there remains widespread misunderstanding of appropriate asthma treatment on the part of both patients and healthcare professionals; this puts people at risk of potentially avoidable adverse outcomes. A key recommendation for enhancing asthma care includes empowering all individuals to take control of their own condition and equipping them to deal with deteriorating symptoms early and appropriately (BTS/SIGN 2016).

Therefore, an important concept in asthma management is supported self-management; a personalised asthma action plan (PAAP) is a potentially important component of that support (Pearce 2016). This plan should detail the person's baseline characteristics, including measures of control (e.g. peak expiratory flow (PEF) and/or symptoms, and should state the agreed maintenance medication. Such plans should also provide clear instruction on how a person should respond to increasing symptoms, with the aim of improving overall asthma control and minimising the risk of exacerbations.

Description of the intervention

Historically, asthma action plans have been referred to by various terms including written action plans, individualised action plans and self-management action plans (Bhogal 2006). As opposed to a discrete intervention (Toelle 2011), PAAPs are considered an essential component of multi-faceted self-management education (Bhogal 2006; BTS/SIGN 2016; GINA 2016; NICE 2013). Although the format and design of action plans may vary (Charlton 1990; D'Souza 1996; Ducharme 2008; Jenkinson 1988; Kristiansen 2012; Marcano Belisario 2013; Turner 1998), they are inherently similar in that they convey individualised self-management instructions to enable people to both attain control of asthma and regain control in the event of an acute exacerbation (Bhogal 2006). For adults, PAAPs may be based on symptoms, on peak flow monitoring or on both, whereas symptom-based plans generally are preferable for children (BTS/SIGN 2016). Typically, content includes objective cues to promote early detection of deteriorating asthma symptoms, medications prescribed and action to take in the event of an acute episode, with particular reference to step-up and step-down therapy, along with health service access (Gibson 2004; Holt 2004; Partridge 2004; Toelle 2011). In principle, individuals are not passive recipients of PAAPs (NICE 2013), as a participatory process is intended to maximise engagement and ensure tailoring of the plan to a person's experience of asthma (Bauman 2003; Gibson 1995; Lahdensuo 1999; Ring 2011). PAAPs should be firmly embedded within the regular review process (BTS/SIGN 2016) to record agreements made between clinician and patient. The modifiable nature of PAAPs is intended to avoid 'prescribing' of static care plans and to ensure the co-production of contemporary self-care advice in the context of the individual (Douglas 2002). In the present review, we will focus on written PAAPs.

How the intervention might work

PAAPs primarily serve to promote self-management of asthma by reminding people of their treatment plan and offering the following directives: which triggers to avoid, when to increase treatment, how to increase treatment, how long to increase treatment and when to seek medical help (Gibson 2004). By promoting and increasing self-management of asthma, PAAPs ultimately aim to improve a person's overall control of his or her asthma symptoms. PAAPs also function as an important communication tool for patients and healthcare professionals, representing both a record and a reminder of discussions between patient and clinician (Bhogal 2006; Welsh 2011). They are individualised, enabling the underlying nature of the person's asthma to be taken into consideration and reviewed on at least an annual basis (BTS/SIGN 2016).

Why it is important to do this review

The national review of UK asthma deaths highlighted that there remain significant levels of avoidable morbidity (e.g. exacerbations requiring oral steroids or admission to hospital) and death from asthma (NRAD 2014). PAAPs are associated with better asthma control in that they help reduce the risk of an exacerbation; for people who have had a recent acute exacerbation resulting in admission to hospital, PAAPs may reduce re-admission rates (NICE 2013). Although both the Global Initiative for Asthma (GINA) (GINA 2016) and British Thoracic Society (BTS)/Scottish Intercollegiate Guidelines Network (SIGN) (BTS/SIGN 2016) guidelines recommend that people are offered self-management education, which should include a written PAAP, these recommendations are based on evidence from over a decade ago (Gibson 2004). Moreover, BTS/SIGN guidelines identify gaps in the evidence on which these guidelines were based. For example, data are insufficient for evaluation of the effectiveness of certain specific components of written PAAPs related to corticosteroid use (BTS/SIGN 2016). Furthermore, debate continues as to the effectiveness of written PAAPs in specific clinical settings (Khan 2014; Sheares 2015a), or when used alone or alongside education on self-management (Toelle 2011). Therefore, it is important that evidence for the effectiveness of PAAPs is re-evaluated systematically to ensure that guidelines accurately reflect an up-to-date evidence base. As PAAPs represent one component of multi-faceted self-management education, and given that provision of health education generally represents a significant cost for hospitals and clinics, it is important to confirm the effectiveness of PAAPs plus education to ensure efficient use of limited resources.

Objectives

To evaluate the effectiveness of PAAPs used alone or in combination with education, for patient-reported outcomes, resource use and safety among adults with asthma.

Methods

Criteria for considering studies for this review

Types of studies

We included parallel randomised controlled trials (RCTs), both blinded and unblinded, of any duration evaluating written PAAPs (for details, see Types of interventions). We included studies reported as full text or published as abstract only and unpublished data.

Types of participants

We included adults (aged 18 years or older) with asthma of any severity. We required that the diagnosis of asthma be determined by a clinician in accordance with validated national or international guidelines (e.g. BTS/SIGN 2016; GINA 2016). We required that studies that did not cite a specific guideline for diagnostic purposes must provide adequate information to allow diagnosis by review authors as per one of the validated guidelines. We excluded participants with other respiratory comorbidities (e.g. bronchiectasis, chronic obstructive pulmonary disease). If a study included only a subset of relevant participants, we included that study only if study authors could provide disaggregated data for participants who meet review inclusion criteria.

Types of interventions

We noted significant variability in the content and format of action plans (MacGillivray 2014). We defined a PAAP as any written plan that enables people with asthma (or their carers) to recognise when symptoms are worse, and that sets out actions to be taken if asthma control should deteriorate. As per GINA 2016 guidelines, we required that PAAPs must include specific instructions for patients (or their carers) regarding changes to reliever and controller medications, ways that oral corticosteroids (OCSs) should be used if needed and when and how healthcare services can be accessed (GINA 2016). Thresholds for action as defined in these plans could be based on symptoms or on peak flow. We assessed the following comparisons.

  1. PAAP alone versus no PAAP.

  2. PAAP plus education intervention (defined per GINA 2016 guidelines) versus education intervention alone.

Types of outcome measures

Primary outcomes
  1. Number of participants reporting at least one exacerbation requiring emergency department visit or hospitalisation

  2. Asthma symptom scores* (measured on a validated scale, e.g. Asthma Control Questionnaire)

  3. Adverse events (all-cause)

We selected the primary outcomes to represent an important measure of resource use, patient-reported outcomes and safety.

Secondary outcomes
  1. Quality of life (QoL)* (measured on a validated scale, e.g. Asthma QoL Questionnaire)

  2. Number of participants reporting at least one exacerbation requiring systemic corticosteroids

  3. Measure of respiratory function: forced expiratory volume in one second (FEV1) or PEF

  4. Days lost from work or study

Reporting one or more of the outcomes listed above was not an inclusion criterion for this review.

Search methods for identification of studies

Electronic searches

We identified trials from the Cochrane Airways Trials Register, which is maintained by the Information Specialist for the Group. The Cochrane Airways Trials Register contains studies identified from several sources.

  1. Monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL), through the Cochrane Register of Studies Online (crso.cochrane.org).

  2. Weekly searches of MEDLINE Ovid SP (1946 to date).

  3. Weekly searches of Embase Ovid SP (1974 to date).

  4. Monthly searches of PsycINFO Ovid SP.

  5. Monthly searches of the Cumulative Index to Nursing and Allied Health Literature (CINAHL) EBSCO.

  6. Monthly searches of the Allied and Complementary Medicine Database (AMED) EBSCO.

  7. Handsearches of the proceedings of major respiratory conferences.

Studies contained in the Trials Register are identified through search strategies based on the scope of Cochrane Airways. We have provided details of these strategies, as well as a list of handsearched conference proceedings, in Appendix 1. See Appendix 2 for search terms used to identify studies for this review.

We searched the following trials registries.

  1. US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (www.clinicaltrials.gov).

  2. World Health Organization International Clinical Trials Registry Platform (apps.who.int/trialsearch).

We searched the Cochrane Airways Trials Register and additional sources from their inception to 14 September 2016 with no restriction on language of publication.

Searching other resources

We checked reference lists of all primary studies and review articles for additional references. We searched relevant manufacturers' websites for trial information.

We searched for errata or retractions from included studies published in full text on PubMed (www.ncbi.nlm.nih.gov/pubmed) on 7 December 2016.

Data collection and analysis

Selection of studies

Two review authors (TG, AR or DE) independently screened titles and abstracts of all studies identified for potential inclusion as a result of the search, and coded them as 'retrieve' (eligible or potentially eligible/unclear) or 'do not retrieve'. We retrieved full-text study reports/publications; two review authors (TG, AR, CM or DE) independently screened the full text and identified studies for inclusion. We identified and recorded reasons for exclusion of ineligible studies. We resolved disagreements through discussion or, if required, through consultation with a third review author. We identified and excluded duplicates and collated multiple reports of the same study so that each study, rather than each report, was the unit of interest in the review. We recorded the selection process in sufficient detail to complete a PRISMA (Prefered Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram and a Characteristics of excluded studies table.

Data extraction and management

We used a data collection form for study characteristics and outcome data that was piloted on at least one study in the review. Two review authors (AR, DE or CM) independently extracted the following study characteristics from each of the included studies.

  1. Methods: study design, total duration of study, details of any 'run-in' period, number of study centres and locations, study setting, withdrawals and date of study.

  2. Participants: number, mean age, age range, gender, severity of condition, diagnostic criteria, baseline lung function, smoking history, inclusion criteria and exclusion criteria.

  3. Interventions: intervention, comparison, concomitant medications and excluded medications.

  4. Outcomes: primary and secondary outcomes specified and collected and time points reported.

  5. Notes: funding for trial and notable conflicts of interest of trial authors.

Two review authors (AR, DE, CM or TG) independently extracted outcome data from each of the included studies. We noted in the Characteristics of included studies table if outcome data were not reported in a useable way. We resolved disagreements by consensus or by consultation with a third review author. One review author (DE) transferred data into Review Manager 5 (RevMan 2014). We double-checked that data were entered correctly by comparing data presented in the systematic review against the study reports. A second review author (CM) performed a spot-check of study characteristics against the trial report for accuracy.

Assessment of risk of bias in included studies

Two review authors (AR, CM, DE or TG) independently assessed the risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We resolved disagreements by discussion or by consultation with a third review author. We assessed risk of bias according to the following domains.

  1. Random sequence generation.

  2. Allocation concealment.

  3. Blinding of participants and personnel.

  4. Blinding of outcome assessment.

  5. Incomplete outcome data.

  6. Selective outcome reporting.

  7. Other bias.

We graded each potential source of bias as high, low or unclear and provided a quote from the study report together with a justification for our judgement in the 'Risk of bias' table. We summarised risk of bias judgements across different studies for each of the domains listed. We considered blinding separately for different key outcomes when necessary (e.g. for unblinded outcome assessment, risk of bias for all-cause mortality may be very different from a participant-reported pain scale). When information on risk of bias was related to unpublished data or to correspondence with a trialist, we noted this in the 'Risk of bias' table.

When considering treatment effects, we took into account the risk of bias for studies that contributed to those outcomes.

Assessment of bias in conducting the systematic review

We conducted the review according to the published protocol and reported deviations from it in the Differences between protocol and review section of the systematic review.

Measures of treatment effect

We analysed dichotomous data as odds ratios and as 95% confidence intervals (CIs). We analysed continuous data as mean differences and 95% CIs. We entered data presented as a scale with a consistent direction of effect. We used change from baseline scores when possible.

We undertook meta-analyses only when this was meaningful (i.e. if treatments, participants and the underlying clinical question were similar enough for pooling to make sense).

We provided a narrative description of skewed data reported as medians and interquartile ranges.

When multiple trial arms were reported in a single trial, we included only the relevant arms. If two comparisons (e.g. intervention A vs placebo and intervention B vs placebo) were combined in the same meta-analysis, we halved the control group to avoid double-counting. If trials reported outcomes at multiple time points, we used the end of treatment time point.

Unit of analysis issues

For dichotomous outcomes, we used participants, rather than events, as the unit of analysis (i.e. number of participants admitted to hospital at least once rather than number of admissions per participant).

Dealing with missing data

We contacted investigators or study sponsors to verify key study characteristics and to obtain missing numerical outcome data when possible (e.g. when a study was identified as abstract only). When this was not possible, and when missing data were thought to introduce serious bias, we explored the impact of including such studies in the overall assessment of results by performing a sensitivity analysis.

Assessment of heterogeneity

We used the I2 statistic to measure heterogeneity among the trials in each analysis. If we identified substantial heterogeneity (i.e. I2 > 50%), we reported this and explored possible causes by performing prespecified subgroup analysis. 

Assessment of reporting biases

If we were able to pool 10 or more trials, we planned to create and examine a funnel plot to explore possible small study and publication biases.

Data synthesis

We used a random-effects model for all analyses, as we expected variation in effects due to differences in study populations and methods. We performed sensitivity analyses using a fixed-effect model.

'Summary of findings' table

We created a 'Summary of findings' table using data from all seven outcomes. We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the quality of a body of evidence as it relates to studies that contributed data to the meta-analyses for prespecified outcomes. We used methods and recommendations as described in Section 8.5 and Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions and used GRADEpro software (Higgins 2011). We justified all decisions to downgrade or upgrade the quality of studies by using footnotes, and we made comments to aid the reader's understanding of the review when necessary.

Subgroup analysis and investigation of heterogeneity

When possible, we planned to carry out the following subgroup analyses for the primary outcomes.

  1. People with recent unscheduled hospitalisation versus people without.

  2. Symptom-based versus peak flow-based PAAPs.

  3. Use of single inhaler therapy (e.g. a single inhaler containing LABA plus ICS used for both prevention and relief of symptoms).

  4. Treatment instructions individualised* using OCS only versus not individualised by OCS only.

  5. Treatment instructions individualised* using ICS versus not individualised by ICS.

  6. Treatment instructions individualised* using participant-specific triggers versus not individualised by participant-specific triggers.

  7. Format of concurrent self-management education (if applicable; e.g. subanalysis of the duration, format or frequency of education).

  8. Provider of self-management education (e.g. physician-led vs nurse-led education).

*Individualisation of action plans was determined based on whether plan templates include blank text boxes for participant-specific asthma treatment instructions or asthma trigger details (MacGillivray 2014).

We used the formal test for subgroup interactions provided in Review Manager 5 (RevMan 2014).

Sensitivity analysis

We planned to carry out sensitivity analyses while excluding the following.

  1. Unpublished data (i.e. no peer-reviewed full-text paper available).

  2. Studies at high risk of bias for blinding.

Results

Description of studies

We have reported details of included studies in the Characteristics of included studies table and have provided a list of excluded studies (with reasons for exclusion) in the Characteristics of excluded studies table.

Results of the search

Through searches of databases, we identified 1094 references (Figure 1). After screening titles and abstracts, we excluded 998 references and sought full-text copies for the remaining 96 references describing 78 studies. Of these, we excluded 66 full-text articles describing 60 studies (see Excluded studies). The remaining 30 articles reported findings from the 18 studies included in this review (15 included studies, 2 ongoing studies, 1 study awaiting classification). We last updated all searches on 14 September 2016.

Figure 1.

Study flow diagram.

Included studies

We included in the review 15 studies described in 27 articles. Four of these studies are reported in multiple articles. Thus, for example, three additional articles describe the study reported in Evans 2005. These 15 included studies randomised a total of 3062 participants (PAAP vs no PAAP: n = 2602 participants; PAAP plus education vs education alone: n = 460). Eleven studies were relevant to the first comparison (PAAP vs no PAAP); eight studies contributed data to the analyses (Ayres 1996; Cowie 1997; Sheares 2015; Hoskins 1996; Jones 1995; Milenković 2007; Nokela 2010; Thoonen 2001), and three provided no data of relevance to this review (Baldwin 1995; Griffiths 2004; Wang 2004). We received a communication just before submission indicating that relevant data from Griffiths 2004 are now available; if successfully sourced, we will include these data in a subsequent update of the review. Four studies were relevant to the second comparison (PAAP plus education vs education alone); two studies contributed data to the analyses (Charrois 2006; Klein 1998), and two provided no data of relevance to this review (McArdle 1997; Sangha 2004).

Methods

Most (11) included studies were parallel-group randomised controlled trials; four were cluster randomised trials for which the primary care centre, rather than the participant, was the unit of randomisation (Griffiths 2004; Hoskins 1996; Nokela 2010; Thoonen 2001). Fourteen of the fifteen included studies were of six months' duration or longer (range six months to two years), and one study had a duration of 14 weeks (Nokela 2010). Most trials did not blind participants or personnel to treatment allocation, although blinding is not feasible with this intervention, and assessor blinding was clearly reported in only two trials (Cowie 1997; Jones 1995). Studies were based in primary care (n = 7; Baldwin 1995; Charrois 2006; Griffiths 2004; Hoskins 1996; Jones 1995; Nokela 2010; Thoonen 2001), secondary care (n = 3; Cowie 1997; McArdle 1997; Sheares 2015), tertiary care (n = 3; Klein 1998; Milenković 2007; Wang 2004) or both primary and secondary care (Ayres 1996), or study setting was not reported (Sangha 2004). Trials were conducted in eight countries including UK (Ayres 1996; Baldwin 1995; Griffiths 2004; Hoskins 1996; Jones 1995), USA (Sheares 2015), Canada (Charrois 2006; Cowie 1997), the Netherlands (Klein 1998; Thoonen 2001), Serbia (Milenković 2007), Hong Kong (Wang 2004), Australia (McArdle 1997) and Sweden (Nokela 2010), or study location was not reported (Sangha 2004).

Participants

We included studies that recruited adults aged 18 years of age and older, or from which data for the adult population could be obtained (Sheares 2015). Individual studies rarely reported the age range of participants, but mean participant age ranged from 22 (Griffiths 2004) to 49 years (Milenković 2007), when reported. Review authors classified asthma severity using a range of definitions across the included studies and assigned participants across the spectrum from mild to severe/high risk. Concomitant medications were infrequently reported.

Interventions
PAAP versus no PAAP

Nine studies assessed PAAPs that had components based on peak flow (Ayres 1996; Baldwin 1995; Cowie 1997; Griffiths 2004; Hoskins 1996; Jones 1995; Milenković 2007; Sheares 2015; Thoonen 2001), one study assessed a PAAP based on symptoms alone (Nokela 2010) and it was not possible to determine the nature of the PAAP for one study that was reported only as an abstract (Wang 2004).

PAAP plus education versus education alone

Three studies assessed PAAPs that had components based on peak flow (Klein 1998; McArdle 1997; Sangha 2004), and the remaining study (Charrois 2006) did not report the nature of the PAAP. Educational components comprised 'generalised asthma education' (McArdle 1997); three consecutive weekly 90-minute sessions provided by a specially trained asthma nurse covering the pathophysiology of asthma, the role and side effects of medication, allergic and non-allergic triggers and symptoms indicating an impending exacerbation (Klein 1998); a 45-minute discussion with visual aids provided by the treating physician on the topic of asthma pathophysiology (Sangha 2004); and an educational component on the topic of 'all asthma medications' (Charrois 2006).

Outcomes

Outcomes were not consistently reported across trials. Five studies that met the review inclusion criteria did not report relevant outcomes (Baldwin 1995; Griffiths 2004; McArdle 1997; Sangha 2004; Wang 2004); when it was reasonable that relevant data may have been collected, we requested data from the trial authors (Griffiths 2004; McArdle 1997; Sangha 2004; Wang 2004); in all cases but one (Griffiths 2004), study authors were not able to provide additional data or we received no response. For the primary outcomes, six studies reported the proportion of participants who experienced an exacerbation requiring an emergency department visit or hospitalisation (Ayres 1996; Charrois 2006; Cowie 1997; Hoskins 1996; Milenković 2007; Nokela 2010); two studies reported asthma control measured on a validated scale (Charrois 2006; Nokela 2010); and two studies reported serious adverse effects (Ayres 1996; Hoskins 1996). For the secondary outcomes, four studies reported quality of life using the Asthma Quality of Life Questionnaire (Klein 1998; Nokela 2010; Sheares 2015; Thoonen 2001); four studies reported the number of participants who experienced an exacerbation requiring treatment with OCSs (Charrois 2006; Hoskins 1996; Jones 1995; Thoonen 2001); four studies reported various measures of lung function (Ayres 1996; Jones 1995; Milenković 2007; Thoonen 2001); and one study reported days lost from work or study (Milenković 2007).

Excluded studies

We excluded 66 full-text articles related to 60 studies. We attributed the high number of exclusions at full-text evaluation to the fact that many abstracts/titles alluded to self-management programmes, but without consulting the full-text reports, it was difficult for review authors to ascertain whether these studies included a PAAP. Of the 60 excluded studies, 29 did not include our selected comparator (PAAP + education, or no PAAP and no education), 22 did not fulfil our definition of the intervention, six used a study design that did not meet our inclusion criteria (i.e. non-randomised or pseudo-randomised) and three did not meet our population criteria (i.e. children only). We have provided additional details in the Characteristics of excluded studies table.

Risk of bias in included studies

We have presented details of the risk of bias associated with each study along with supporting evidence in the Characteristics of included studies tables. Figure 2 presents a summary of risk of bias judgements according to study and domain, and Figure 3 depicts the risk of bias for each domain (see also following subsections) across all included studies.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Figure 3.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Allocation

All studies had low or unknown risk of selection bias. Six of the 15 included studies were associated with low risk of bias for random sequence generation (Charrois 2006; Cowie 1997; Griffiths 2004; Hoskins 1996; Nokela 2010; Sheares 2015), but the remaining studies provided insufficient information. Four studies were associated with low risk of bias in the allocation concealment process (Charrois 2006; Cowie 1997; Klein 1998; Sheares 2015) but the remaining studies did not provide sufficient information to inform a rating. We considered no studies to be at high risk of selection bias.

Blinding

We considered all included studies to be at high risk of performance bias, but this was not a consequence of poor design, as blinding of participants and personnel was not feasible for this intervention. Performance-related outcome measures, such as peak flow, asthma control and quality of life, may have been susceptible to detection bias. Outcomes such as exacerbations and serious adverse events were less likely to be influenced by participants' or investigators' knowledge of the intervention. We considered two trials that blinded outcome assessment to be at low risk of potential detection bias (Cowie 1997; Griffiths 2004); eight studies provided insufficient information (detection bias unknown), and we considered the remaining five studies to be at high risk of detection bias (Ayres 1996; Baldwin 1995; Hoskins 1996; Nokela 2010; Thoonen 2001).

Incomplete outcome data

Seven studies had low risk of attrition bias; three others provided insufficient information and we judged their risk of bias as unknown. Five studies had high risk of attrition bias owing to incomplete outcome data (Ayres 1996; Hoskins 1996; Jones 1995; Nokela 2010; Sheares 2015).

Selective reporting

Three studies were at low risk of reporting bias (Charrois 2006; Klein 1998; Sheares 2015). A publicly provided protocol was not available for most studies, resulting in a judgement of 'unknown' risk of reporting bias. We considered two studies to be at high risk of reporting bias (Cowie 1997; Jones 1995).

Other potential sources of bias

We considered three studies to be at high risk of 'other' bias. Pharmacist compliance with the intervention was poor in Charrois 2006. This meant that only three-quarters of the intervention group received a written asthma action plan (WAAP), and less than half of participants received education about WAAP at each pharmacy visit. Hoskins 1996 reported a between-group imbalance in morbidity at baseline. Although these investigators reported some outcome measures as changes from baseline, this was not the case for all outcomes, and the magnitude or direction of treatment effect may have been affected. Thoonen and colleagues noted that participants who received PAAPs were provided with an oral course of prednisolone, and that this prescription may have been incorrectly interpreted as evidence of use of prednisolone during an exacerbation; thus data on exacerbations requiring treatment with an OCS may overestimate the number of participants with an exacerbation requiring an OCS in the PAAP group compared with the control group (Thoonen 2001). We considered three studies to have unknown risk of 'other' bias because it was not clear whether imbalance in baseline characteristics between groups would affect outcomes (Griffiths 2004; Nokela 2010; Sheares 2015). We considered the remaining included studies to have low risk of 'other' bias.

Effects of interventions

See: Summary of findings for the main comparison PAAP compared with no PAAP for adults with asthma; Summary of findings 2 PAAP plus education compared with education alone for adults with asthma

PAAP versus no PAAP

Primary outcomes
Number of participants reporting at least one exacerbation requiring emergency department visit or hospitalisation

Five studies involving 1385 participants found no statistically significant difference in the number of exacerbations requiring an emergency department (ED) visit or hospitalisation between those participants receiving PAAP and those not receiving PAAP (odds ratio (OR) 0.75, 95% confidence interval (CI) 0.45 to 1.24) (Analysis 1.1). Among those who used a PAAP (vs no PAAP), we estimated that 19 fewer people per 1000 would have an exacerbation requiring an ED visit/hospitalisation, but confidence intervals ranged from 43 fewer to 18 more. We observed a low level of heterogeneity for this outcome (I2 = 17%). Three studies measured this outcome at six months, and the remaining two studies measured this outcome at three months and 12 months. The quality of the evidence was low, as we had downgraded it once for risk of bias (3/5 studies at risk of attrition bias and baseline imbalance in morbidity as reported by Hoskins 1996 (weight 48.8%) and once for imprecision (small total number of events; sample size insufficient (optimal size > 4K) and confidence intervals include null effect and chance of appreciable benefit).

Asthma symptom scores

One study of 141 participants assessed change from baseline on the Asthma Control Questionnaire and reported a mean difference (MD) of -0.16 (95% CI -0.25 to -0.07) (Analysis 1.2). The quality of the evidence was low, as we had downgraded it once for risk of bias (high risk of performance, detection and attrition bias) and once for indirectness (based on only one study, therefore limiting generalisability).

Serious adverse events (including death)

Two studies contributed data on serious adverse events (SAEs), including deaths (Ayres 1996; Hoskins 1996). However, the SAEs reported in Hoskins 1996 comprised deaths that were considered unrelated to asthma. Therefore, we did not combine these events with data on SAEs from Ayres 1996. Results showed no statistically significant differences in SAEs between participants receiving a PAAP and those not receiving a PAAP (OR 3.26, 95% CI 0.33 to 32.21; 125 participants; one study) (Analysis 1.3). Among those who used a PAAP (vs no PAAP), we estimated that 33 more people per 1000 would have an SAE; confidence intervals ranged from 11 fewer to 522 more. We considered the quality of the evidence to be very low, as we had downgraded it once for risk of bias (attrition bias), once for imprecision (few events, insufficient sample size and CI, including null effect and appreciable risk of harm) and once for indirectness (limited generalisability of single study).

Secondary outcomes
Quality of life

We analysed data from three studies with 441 participants that assessed change in score from baseline on the Asthma Quality of Life Questionnaire (AQLQ) and found statistically significant improvement in quality of life scores for those receiving a PAAP compared with those not receiving a PAAP (mean difference (MD) 0.18, 95% CI 0.05 to 0.30) (Analysis 1.4). However, the magnitude of the MD was lower than the established minimum clinically important difference (MCID 0.5) and is thus unlikely to be of clinical relevance. We noted a moderate level of heterogeneity (I2 = 61%). Each study measured outcomes at a different time point, namely, three months, 12 months and 24 months post recruitment. The quality of the evidence was low, as we had downgraded it twice for risk of bias (performance, detection and attrition bias).

Number of participants reporting at least one exacerbation requiring systemic corticosteroids

We analysed data from three studies involving 1136 participants and found that use of PAAP had no significant effect on the number of participants reporting at least one exacerbation requiring oral systemic corticosteroids (OR 1.45, 95% CI 0.84 to 2.48) (Analysis 1.5). We observed a moderate level of heterogeneity (I2 = 50%). We considered the quality of the evidence to be very low, as we had downgraded it twice for risk of bias (attrition bias and baseline imbalance in morbidity as reported by Hoskins 1996 (weight 54.9%); other risk of bias based on a reporting error in the study reported by Thoonen 2001) and once for imprecision (CI including null effect and chance of appreciable benefit).

Measures of respiratory function

Results showed no statistically significant difference in change in FEV1 from baseline when groups receiving PAAP were compared with those not receiving PAAP (MD -0.04, 95% CI -0.25 to 0.17); we noted moderate heterogeneity (I2 = 50%) (Analysis 1.6). Three studies with a total of 392 participants assessed this outcome. The quality of the evidence was low, as we had downgraded it once for risk of bias (detection bias and attrition bias) and once for inconsistency (opposite direction of effect observed in one study).

Data from two studies (146 participants) showed no statistically significant difference in the change from baseline of % predicted FEV1 when the PAAP group was compared with the non-PAAP group (MD 0.40, 95% CI -6.05 to 6.85) (Analysis 1.7). Findings show no heterogeneity (I2 = 0%), and the quality of the evidence was low, as we had downgraded it once for risk of bias (attrition and reporting bias) and once for inconsistency (opposite direction of effect).

One study of 72 participants assessed change from baseline in % predicted PEF and found no difference between the two groups (MD 1.20, 95% CI -5.67 to 8.07) (Analysis 1.8). The quality of the evidence was low, as we had downgraded it once for risk of bias (performance, attrition and reporting) and once for indirectness (limited generalisability of single study).

Similarly, one study measured change from baseline in PEF among a total of 125 participants and found no difference between the group receiving PAAP and the group not receiving PAAP (MD -18.00, 95% CI -54.03 to 18.03) (Analysis 1.9). The quality of the evidence was very low, as we had downgraded it once for risk of bias (attrition bias), once for indirectness (limited generalisability of single study) and once for imprecision (wide confidence intervals encompassing 72 L/min).

Days lost from work or study

One study counted days lost from work or study and found that the 37 participants receiving PAAP had a significant reduction in the number of days lost compared with the 37 participants who did not receive PAAP (MD -6.20, 95% CI -7.32 to -5.08) (Analysis 1.10). The quality of the evidence was low, as we had downgraded it twice for indirectness (limited generalisability of single study; study performed in tertiary care setting in Serbia).

Subgroup analyses

As per the protocol, we intended to perform prespecified subgroup analyses on the primary outcomes. The outcome 'number of participants reporting at least one exacerbation requiring emergency department visit or hospitalisation' was the only primary outcome for which a sufficient number of studies contributed data to permit subgroup analysis. The following subgroup analyses were not feasible because insufficient information was provided in published reports or reporting of key variables was inconsistent: people with recent unscheduled hospitalisation versus people without (information not reported by all contributing studies); symptom-based versus peak flow-based plans (all studies used peak flow-based plans or the type of plan was not reported); use of single-inhaler therapy (not reported by any included study); treatment instructions individualised using OCS/ICS/participant-specific triggers (inconsistently reported across included studies). The final two planned subgroup analyses (format of concurrent self-management education; provider of concurrent self-management education) were not relevant to this comparison.

Sensitivity analyses

The outcome 'number of participants reporting at least one exacerbation requiring emergency department visit or hospitalisation' was the only outcome with a sufficient number of contributing studies to permit the prespecified sensitivity analyses. However, no prespecified sensitivity analyses were feasible because unpublished data did not contribute to this outcome, all studies contributing data to this outcome were assessed as having high risk of performance bias and only one study was assessed as having low risk of detection bias (Cowie 1997).

PAAP plus education intervention (defined per GINA 2015 guidelines) versus education intervention alone

Primary outcomes
Number of participants reporting at least one exacerbation requiring emergency department visit or hospitalisation

One study assessed exacerbations requiring an emergency department visit or hospitalisation and found no difference between the group receiving PAAP and group receiving education alone (OR 1.08, 95% CI 0.27 to 4.32; 70 participants; one study) (Analysis 2.1). For people who used a PAAP plus education (vs education alone), we estimated that 15 more people per 1000 would have an exacerbation requiring an emergency department visit/hospitalisation, but confidence intervals ranged from 176 fewer to 344 more. The quality of the evidence was very low, as we had downgraded it once for risk of bias ('other': participants did not receive the intervention as planned), once for indirectness (limited generalisability of single study) and once for imprecision (CI including null effect and risk of appreciable harm or benefit).

Asthma symptom scores

One study of 70 participants evaluated change in score on the Asthma Control Questionnaire from baseline and found no difference between the group receiving PAAP with an educational intervention and the group receiving education alone (MD -0.10, 95% CI -0.54 to 0.34; 70 participants; one study) (Analysis 2.2). The quality of the evidence was low, as we had downgraded it once for risk of bias ('other': participants did not receive the intervention as planned) and once for indirectness (limited generalisability of single study).

Serious adverse events (including death)

No studies reported data for this outcome.

Secondary outcomes
Quality of life

No difference was found in changes in score from baseline on the Asthma Quality of Life Questionnaire between a group of 84 participants receiving PAAP and education and a group of 90 participants in the same study receiving education alone (MD 0.13, 95% CI -0.13 to 0.39; 174 participants; one study) (Analysis 2.3). The quality of the evidence was low, as we had downgraded it once for risk of bias ('performance bias) and once for indirectness (limited generalisability of single study).

Number of participants reporting at least one exacerbation requiring systemic corticosteroids

One study that assessed use of PAAP and education compared with education alone found no statistically significant differences between groups in terms of the number of participants reporting at least one exacerbation requiring oral systemic corticosteroids (OR 0.28, 95% CI 0.07 to 1.12; 70 participants; one study) (Analysis 2.4). The quality of the evidence was very low, as we had downgraded it once for risk of bias ('other': participants did not receive the intervention as planned), once for indirectness (limited generalisability of single study) and once for imprecision (CI including null effect and risk of appreciable benefit).

Measures of respiratory function

No studies reported data for this outcome.

Days lost from work or study

No studies reported data for this outcome.

Subgroup and sensitivity analyses

For this comparison, the number of studies contributing data to any of the primary outcomes was insufficient to permit subgroup or sensitivity analyses.

Discussion

Summary of main results

Of the 15 studies included in this review, 10 provided data relevant for analyses. Of these 10, eight studies compared a personalised asthma action plan (PAAP) versus no PAAP, and two studies compared PAAP plus education versus education alone. For both comparisons, our primary outcomes were the number of participants reporting at least one exacerbation requiring an emergency department visit or hospitalisation, change in asthma symptom scores and serious adverse events, including death. Secondary outcome measures were change in quality of life scores, number of exacerbations requiring oral corticosteroids, change in respiratory function tests and number of days lost from work or study.

PAAP versus no PAAP

Data on exacerbations requiring emergency department attendance or hospitalisation were available for five studies with 1385 participants. The meta-analysis did not show a statistically significant effect of the PAAP intervention on exacerbations, but this is not considered strong evidence of no effect, as follow-up measurement intervals were inconsistent (3 to 12 months), event frequencies were very low in three trials and overall methodological quality was relatively low.

Data from a validated asthma symptom score was available from only one study with 141 participants, which reported a statistically significant mean difference (MD) of -0.16 (95% confidence interval (CI) -0.25 to -0.07) in scores from the Asthma Control Questionnaire, although this is below the 0.5 threshold for a minimum clinically important difference and we considered the overall quality of the evidence to be low.

Adverse events data were available from two studies with 441 participants, but we excluded one from the analyses, as reported deaths were not asthma related (Hoskins 1996). Results showed no significant difference in serious adverse events reported in Ayres 1996, but this finding was based on a very low event frequency (four), making it difficult for review authors to draw firm conclusions.

Three studies contributed data on quality of life from the Asthma Quality of Life Questionnaire (AQLQ). PAAP was associated with a statistically significant improvement in quality of life, but the mean difference in score of 0.18 was below the minimum threshold of 0.5 considered clinically relevant (low-quality evidence). Three studies contributed data on exacerbations requiring oral corticosteroids, but the effect was not statistically significant (very low-quality evidence). Four studies provided data on measures of respiratory function including forced expiratory volume in one second (FEV1), FEV1 % predicted, peak expiratory flow (PEF) and PEF % predicted, but effects were not statistically or clinically significant (low-quality evidence). One study with 74 participants showed a significant reduction in days lost from work with the intervention (MD -6.2 days, 95% CI -7.32 to -5.08) but the quality of evidence was low. The low or very low quality of evidence limits our capacity to draw firm conclusions based on secondary outcomes.

PAAP plus education versus education intervention alone

Only one study provided data on exacerbations requiring an emergency department visit or hospitalisation (Charrois 2006) and found no evidence of a significant difference. This same study reported no significant difference in AQLQ scores, although we considered the quality of evidence from this study to be low. No studies reported data on adverse events.

One study reported no significant differences in change in AQLQ scores (low-quality evidence), and one study reported no significant differences in exacerbations requiring oral corticosteroids, although again, this finding was based on low-quality evidence. No data were available for measures of respiratory function nor for days lost from work or study.

In summary, our analyses were unable to demonstrate significant benefit or harm associated with use of a PAAP, with or without an educational component, for our primary outcomes. However, the overall low quality of the evidence precludes robust conclusions on the role of PAAP in adult asthma.

Overall completeness and applicability of evidence

Although 15 studies met the inclusion criteria, only 10 included outcomes relevant to the review and half of these were considered to have high risk bias owing to incomplete outcome data (Ayres 1996; Hoskins 1996; Jones 1995; Nokela 2010; Sheares 2015). For studies that contributed data, of the 2497 randomised participants (n = 2152 PAAP vs no PAAP; n = 315 PAAP plus education vs education alone), 284 did not complete the trial (n = 257 PAAP vs no PAAP; n = 27 PAAP plus education vs education alone). In studies for which details of withdrawal were given for each study group (PAAP vs no PAAP) (Ayres 1996; Cowie 1997; Hoskins 1996; Milenković 2007; Nokela 2010; Sheares 2015; Thoonen 2001), rates tended to be higher in the intervention arms. Study duration appeared to have no effect. Data from Hoskins 1996 showed that when general practitioners (GPs) were randomised to intervention and comparison arms (i.e. a cluster randomised trial), a much higher percentage of GPs in the comparator arm compared with those issuing PAAPs returned data on participants with asthma (83% vs 51%). The newly updated British Thoracic Society (BTS)/Scottish Intercollegiate Guidelines Network (SIGN) guidelines (BTS/SIGN 2016) and evidence presented in Ring 2011 and Pinnock 2015 highlight that successful implementation of effective self-management interventions is associated with empowered patients and knowledgeable staff working within an organisational culture that promotes asthma self-management; this can be particularly challenging in primary care. Hoskins 1996 may indicate that GP/patient compliance with the intervention was poor.

The BTS/SIGN asthma guidelines issued since 2008 and the National Institute for Clinical Excellence (NICE) Quality Standard for Asthma (NICE 2013) recommend provision of PAAPs (as opposed to verbal instructions alone) along with structured education, yet most studies contributing data to this review (n = 10), including the most recent study (Nokela 2010), did not include education as a comparator (n = 8). This suggests that recent empirical research has not addressed guideline recommendations. For the two older studies that featured education as a comparator (Charrois 2006; Klein 1998), data could not be pooled owing to lack of homogeneity in outcome measures.

Powell 2002 reported significant improvement in outcomes with self-monitoring based on peak expiratory flow or symptom control plus regular review, but only two studies in this review used a symptom-based PAAP and evidence may be insufficient to show effectiveness. Heterogeneity was considerable with respect to the structure/format of the PAAP used across studies, although we were generally satisfied that the PAAPs used in the included studies conformed to the key features described in BTS/SIGN guidelines (BTS/SIGN 2016). As further discussed later, whether participants were provided with a course of oral corticosteroids (OCSs) for self-administration on the basis of a predefined threshold of symptoms or lung function potentially confounds our findings, and included studies varied as to whether OCSs were provided for self-administration, or whether participants were required to seek medical consultation for OCS treatment.

Studies reported considerable variation in methods used to assess asthma severity during recruitment that may have influenced differences between study arms and between trials, owing to unequal distribution of asthma severity among participants, which in turn may have offered greater opportunity for improvement in more severe cases. In Ayres 1996, participants who were self-managed had better lung function and asthma severity scores at baseline than those managed by their physician. Furthermore, a predefined criterion required that we should exclude studies that enrolled patients with respiratory comorbidities (e.g. chronic obstructive pulmonary disease (COPD)); thus the applicability of current findings must be considered in this context.

All studies reported the mean age of participants (one reported age range), suggesting that adults 60 years of age and older are under-represented, although this is a common feature of asthma research (BTS/SIGN 2016).

Finally, it is important to acknowledge that the outcomes examined in this review included elements commonly specified in PAAPs (e.g. use of OCS, visit to the emergency department). This potentially confounds the findings of included studies and could result in an underestimation of the efficacy of PAAPs, because individuals who received a PAAP would be more likely to experience a given event (e.g. exacerbation requiring OCS use) compared with individuals in the control group if the related intervention (e.g. OCS) was prespecified in the action plan. In this respect, it is possible that the outcome 'exacerbations requiring treatment with OCS' functions as a measure of self-management, whereby participants take action to treat an exacerbation, rather than relying on inhaled medicines or going to the emergency department. Additionally, we noted heterogeneity between studies with respect to provision of an 'OCS rescue pack' (intended to be taken as laid out in the personalised plan). For these reasons, we have elected to refrain from presenting results for the OCS-related outcome in terms of absolute numbers, which could be misleading. However, despite these limitations, the selected outcomes examined in this review represent commonly used measures of efficacy and safety in randomised controlled trials of participants with asthma, and it may be difficult to assess the effectiveness of PAAPs without using these outcomes.

Quality of the evidence

We judged that three of the 15 included studies had low risk of selection bias (Charrois 2006; Cowie 1997; Griffiths 2004) and that all other studies poorly documented some aspect of the selection process, leading to our determination that risk of bias for these studies was unclear. Risk of performance bias for all 15 studies was high owing to study design and the self-management intervention. We judged two studies to have low risk of detection bias and five to have high risk, and risk was unclear in the remaining eight studies. We also judged five studies to be at high risk of attrition bias, three others to be at unclear risk and the remaining seven studies to be at low risk. We judged two studies to be at high risk of reporting bias, three studies at low risk and 10 studies at unclear risk. We had significant concerns about other forms of bias in three studies. In summary, risk of bias was highly variable between studies.

We rated the overall quality of the evidence as low or very low in our GRADE assessment, which takes into account risk of bias (study limitations), as well as indirectness, imprecision, consistency of effect and risk of publication bias. This rating was largely due to high risk of bias as well as issues related to imprecision and indirectness. It was not clear whether publication bias was an issue because studies were insufficient for a formal assessment.

Potential biases in the review process

We conducted the review according to guidelines provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). The Cochrane Airways Group Trials Search Co-ordinator designed and performed the search process, and two review authors with expert clinical knowledge independently screened search results. We are confident that we identified all potentially relevant randomised trials. Similarly, two review authors independently performed each step in the systematic review process requiring a subjective decision (e.g. extraction of data, assessment of risk of bias, GRADE assessment) and, if necessary, resolved disagreements by consulting a third review author. A potential sample bias could result from the selective use of disaggregated data; however, this approach is a pragmatic necessity. This review has undergone editorial and peer review to ensure that the opinion of external experts has been considered. Therefore, we are confident that our conclusions fairly represent the current evidence base for this clinical question.

Agreements and disagreements with other studies or reviews

More than a decade ago, Le Fevre 2002 conducted a systematic review of randomised controlled trials in adults and children that compared written action plans versus no plan (five studies) and peak flow monitoring without a plan versus peak flow monitoring with a plan (two studies). Heterogeneity of included studies precluded meta-analysis, and a narrative review of findings suggested that most studies did not report improved outcomes with addition of an action plan. However, review authors suggested that all included studies were of low quality, limiting confidence in the findings, and stated that evidence available at the time did not permit firm conclusions. The current review includes more recent studies, although our finding that many studies are of low quality and our limited confidence in findings of little evidence of benefit (or harm) are similar.

Bhogal 2006 reviewed the effect of providing PAAPs for children specifically and found no studies that compared provision of a PAAP versus no PAAP. A later paper (Zemek 2008) updated the search and included one extra study, which did look at the comparison of PAAP versus no PAAP. Review authors reported that this one study (with 68 children) suggested that an action plan reduced the mean number of acute care visits, symptoms and nocturnal awakenings and reduced time lost from school, but again could offer no firm conclusions on the effectiveness of a PAAP on the basis of this single study. Individual non-randomised studies also support benefit for PAAPs. For example, among patients with moderate to severe asthma, not possessing a written asthma action plan was associated with increased acute use of healthcare services (Adams 2009).

PAAPs are often included as part of self-management programmes, and Powell 2002 examined different aspects of self-management programmes for adults (over 16 years of age), including PAAPs. Six studies compared self-adjustment of medications according to a PAAP versus adjustment by a doctor and found no differences in outcomes including hospitalisation, emergency department visits, unscheduled doctor visits and incidence of nocturnal asthma; therefore, study authors concluded that the two approaches were equally effective. Only one study compared written plans versus verbal instruction and found no difference in healthcare use or lung function, but study authors suggested that this finding needed further corroboration in future studies. Gibson 2003 reviewed 36 trials comparing self-management education approaches for adults (over 16 years of age) versus usual care; 18 included a written PAAP. In general, review authors found that self-management reduced hospitalisations, ED visits, unscheduled doctor visits, days off work or school and incidence of nocturnal asthma, and that it improved quality of life (but not lung function). In subgroup analyses of studies implementing optimal self-management education (which involved a written plan, self-monitoring and regular review), many positive outcomes remained (reduced hospitalisations, ED visits, unscheduled doctor visits and incidence of nocturnal asthma). Study evidence led review authors to conclude that self-management was effective, and in particular that optimal self-management education should be offered to adults with asthma. However, it was not possible to discern from this review the contributions of action plans specifically. Furthermore, findings from this review are now over a decade old.

Tapp 2007 focused on adults who had attended an ED for an asthma exacerbation and examined whether asthma education (including written PAAPs) improved health outcomes. The investigators found that education reduced hospital (re)admission (high-quality evidence) but did not appear to reduce re-presentation at an ED (low-quality evidence). Education also led to improved symptoms but not to improvement in peak flow, quality of life or days of work/study lost (but these null outcomes involved few studies and large variation across studies). In addition, the education provided revealed considerable heterogeneity across all studies reviewed, for example, only nine of the 13 included studies provided a PAAP, and again, the effectiveness of the PAAP specifically could not be ascertained.

More recently, Peytremann-Bridevaux 2015 evaluated the effectiveness of chronic disease self-management programmes for asthma in 20 included studies (12 provided action plans as part of the programme). In addition to self-management, these programmes included an organisational component targeting patients and one targeting professionals, as well as at least two healthcare professionals involved in the patient’s care. Given the complexity of these programmes, it was not possible to determine the effect of action plans alone. Indeed as the review authors note, in some studies, participants in both intervention and usual care arms had action plans; in other studies, the proportion of participants using action plans changed throughout the study; and in other studies, the proportion of participants with plans was not reported.

Authors' conclusions

Implications for practice

Development of a PAAP and structured education for patients are endorsed by BTS and NICE guidelines (BTS/SIGN 2016; NICE 2013). Our findings are based on a small number of studies of poor quality, so results of this review should be interpreted with caution. Furthermore, we have identified multiple confounding factors that would make it difficult to demonstrate efficacy for a single component of a multi-component self-management strategy (Pinnock 2015; Ring 2011). With consideration of these caveats, this systematic review, which considered evidence from randomised controlled trials, did not find additional benefit from the use of PAAPs, with or without education, across key asthma outcomes including exacerbation frequency, hospitalisation and measures of asthma control. Equally, there was no indication from the included studies of adverse outcomes with the use of PAAPs.

Implications for research

Review conclusions are based on a relatively small number of studies of poor quality, and interpretation is limited by lack of consistency in terms of design, populations, interventions and outcomes. Further high-quality research is required to determine whether PAAPs alone, or in combination with education, have an impact on important outcomes such as symptom control and indirect costs such as days lost from work. Future studies should reflect a broad population demographic, including older adults and people from different ethnic groups. The format of PAAPs used in future research should be consistent with BTS/SIGN guidelines (BTS/SIGN 2016), that is, they "should include specific advice about recognising loss of asthma control, assessed by symptoms or peak flows or both; and actions, summarised as two or three action points, to take if asthma deteriorates, including seeking emergency help, starting oral steroids (which may include provision of an emergency course of steroid tablets), restarting or temporarily increasing (as opposed to just doubling) ICS, as appropriate to clinical severity". Furthermore, careful consideration should be given to whether selected outcomes could confound study findings as the result of overlap with measures instructed by PAAPs.

Acknowledgements

The Background and Methods sections of this review are based on a standard template used by the Cochrane Airways Group. Thank you to Elizabeth Stovold for help with the search strategy, and to Chris Cates, Emma Dennett and Kayleigh Kew for advice and support.

Sean Beggs was the Editor for this review and commented critically on the review.

Data and analyses

Download statistical data

Comparison 1. PAAP versus no PAAP
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of participants reporting at least 1 exacerbation requiring emergency department visit or hospitalisation51385Odds Ratio (M-H, Random, 95% CI)0.75 [0.45, 1.24]
2 Asthma symptom scores (change from baseline in ACQ)1 Mean Difference (IV, Random, 95% CI)Totals not selected
3 Serious adverse events (including deaths)1 Odds Ratio (M-H, Random, 95% CI)Subtotals only
4 Quality of life (change from baseline in AQLQ)3441Mean Difference (IV, Random, 95% CI)0.18 [0.05, 0.30]
5 Number of participants reporting at least 1 exacerbation requiring systemic corticosteroids31136Odds Ratio (M-H, Random, 95% CI)1.45 [0.84, 2.48]
6 Measure of respiratory function (change from baseline in FEV1 (L))3392Mean Difference (IV, Random, 95% CI)-0.04 [-0.25, 0.17]
7 Measure of respiratory function (change from baseline in % predicted FEV1)2146Mean Difference (IV, Random, 95% CI)0.40 [-6.05, 6.85]
8 Measure of respiratory function (change from baseline in % predicted PEF)1 Mean Difference (IV, Random, 95% CI)Totals not selected
9 Measure of respiratory function (change from baseline in PEF (L/min))1 Mean Difference (IV, Random, 95% CI)Totals not selected
10 Days lost from work or study174Mean Difference (IV, Random, 95% CI)-6.2 [-7.32, -5.08]
Analysis 1.1.

Comparison 1 PAAP versus no PAAP, Outcome 1 Number of participants reporting at least 1 exacerbation requiring emergency department visit or hospitalisation.

Analysis 1.2.

Comparison 1 PAAP versus no PAAP, Outcome 2 Asthma symptom scores (change from baseline in ACQ).

Analysis 1.3.

Comparison 1 PAAP versus no PAAP, Outcome 3 Serious adverse events (including deaths).

Analysis 1.4.

Comparison 1 PAAP versus no PAAP, Outcome 4 Quality of life (change from baseline in AQLQ).

Analysis 1.5.

Comparison 1 PAAP versus no PAAP, Outcome 5 Number of participants reporting at least 1 exacerbation requiring systemic corticosteroids.

Analysis 1.6.

Comparison 1 PAAP versus no PAAP, Outcome 6 Measure of respiratory function (change from baseline in FEV1 (L)).

Analysis 1.7.

Comparison 1 PAAP versus no PAAP, Outcome 7 Measure of respiratory function (change from baseline in % predicted FEV1).

Analysis 1.8.

Comparison 1 PAAP versus no PAAP, Outcome 8 Measure of respiratory function (change from baseline in % predicted PEF).

Analysis 1.9.

Comparison 1 PAAP versus no PAAP, Outcome 9 Measure of respiratory function (change from baseline in PEF (L/min)).

Analysis 1.10.

Comparison 1 PAAP versus no PAAP, Outcome 10 Days lost from work or study.

Comparison 2. PAAP plus education versus education alone
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of participants reporting at least 1 exacerbation requiring emergency department visit or hospitalisation1 Odds Ratio (Fixed, 95% CI)Subtotals only
2 Asthma symptom scores (change from baseline in ACQ score)1 Mean Difference (IV, Random, 95% CI)Subtotals only
3 Quality of life (change from baseline in AQLQ score)1 Mean Difference (IV, Random, 95% CI)Subtotals only
4 Number of participants reporting at least 1 exacerbation requiring systemic corticosteroids1 Odds Ratio (Random, 95% CI)Subtotals only
Analysis 2.1.

Comparison 2 PAAP plus education versus education alone, Outcome 1 Number of participants reporting at least 1 exacerbation requiring emergency department visit or hospitalisation.

Analysis 2.2.

Comparison 2 PAAP plus education versus education alone, Outcome 2 Asthma symptom scores (change from baseline in ACQ score).

Analysis 2.3.

Comparison 2 PAAP plus education versus education alone, Outcome 3 Quality of life (change from baseline in AQLQ score).

Analysis 2.4.

Comparison 2 PAAP plus education versus education alone, Outcome 4 Number of participants reporting at least 1 exacerbation requiring systemic corticosteroids.

Appendices

Appendix 1. Sources and search methods for the Cochrane Airways Group Trials Register

Electronic searches: core databases

Database Frequency of search
CENTRAL (the Cochrane Library)Monthly
MEDLINE (Ovid)Weekly
Embase (Ovid)Weekly
PsycINFO (Ovid)Monthly
CINAHL (EBSCO)Monthly
AMED (EBSCO)Monthly

Handsearches: core respiratory conference abstracts

Conference Years searched
American Academy of Allergy, Asthma and Immunology (AAAAI)2001 onwards
American Thoracic Society (ATS)2001 onwards
Asia Pacific Society of Respirology (APSR)2004 onwards
British Thoracic Society (BTS) winter meeting2000 onwards
Chest Meeting2003 onwards
European Respiratory Society (ERS)1992, 1994, 2000 onwards
International Primary Care Respiratory Group Congress (IPCRG)2002 onwards
Thoracic Society of Australia and New Zealand (TSANZ)1999 onwards

MEDLINE search strategy used to identify trials for the Register

Asthma search

1. exp Asthma/

2. asthma$.mp.

3. (antiasthma$ or anti-asthma$).mp.

4. Respiratory Sounds/

5. wheez$.mp.

6. Bronchial Spasm/

7. bronchospas$.mp.

8. (bronch$ adj3 spasm$).mp.

9. bronchoconstrict$.mp.

10. exp Bronchoconstriction/

11. (bronch$ adj3 constrict$).mp.

12. Bronchial Hyperreactivity/

13. Respiratory Hypersensitivity/

14. ((bronchial$ or respiratory or airway$ or lung$) adj3 (hypersensitiv$ or hyperreactiv$ or allerg$ or insufficiency)).mp.

15. ((dust or mite$) adj3 (allerg$ or hypersensitiv$)).mp.

16. or/1-15

Filter to identify randomised controlled trials

1. exp "clinical trial [publication type]"/

2. (randomised or randomised).ab,ti.

3. placebo.ab,ti.

4. dt.fs.

5. randomly.ab,ti.

6. trial.ab,ti.

7. groups.ab,ti.

8. or/1-7

9. Animals/

10. Humans/

11. 9 not (9 and 10)

12. 8 not 11

We will adapt the MEDLINE strategy and RCT filter to identify trials in other electronic databases.

Appendix 2. Search strategy to identify relevant trials from the Cochrane Airways Group Trials Register

#1 AST:MISC1

#2 MeSH DESCRIPTOR Asthma Explode All

#3 asthma*:ti,ab

#4 #1 or #2 or #3

#5 MeSH DESCRIPTOR Individualized Medicine

#6 MeSH DESCRIPTOR Patient Education as Topic

#7 MeSH DESCRIPTOR Self Care

#8 MeSH DESCRIPTOR Patient Care Planning Explode All

#9 PAAP:ti,ab

#10 action-plan* or action* NEXT plan*

#11 written* NEAR3 plan*

#12 management* NEAR3 plan*

#13 self-management* or self* NEXT management*

#14 self-care* or self* NEXT care*

#15 self-action*

#16 medication* NEAR3 plan*

#17 tailored*

#18 individuali*ed

#19 personali*ed

#20 individual* NEAR plan*

#21 personal* NEAR plan*

#22 pictorial* NEAR plan*

#23 care* NEAR3 plan*

#24 *treatment* NEAR3 plan*

#25 goal* NEAR3 set*

#26 therapeutic* NEAR (plan* or strategy or educat* or management)

#27 #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 OR #22 or #23 or #24 or #25 or #26

#28 #4 and #27

[In search line #1, MISC1 denotes the field in which the reference has been coded for condition, in this case, asthma]

What's new

DateEventDescription
12 April 2017AmendedAR affiliation and COI statement corrected.

Contributions of authors

All review authors contributed to drafting of the protocol, reviewed it critically for intellectual content, provided final approval of the version to be published and are accountable for all aspects of the work.

Declarations of interest

David Evans: provides freelance medical writing services to medical communications agencies.

Alison Rushton: undertook a feasibility study to pilot a locally developed asthma self-management plan for children and young people within a Clinical Commissioning Group (CCG) locality in the northwest of England. The project was completed in 2015 as part of a Clinical Academic Internship, funded by Health Education England and a northwest CCG. The intern received no payment for including individuals in the study.

Nathan Halcovitch: none.

Fiona Eccles: none.

Timothy Gatheral: none.

Sally Spencer: serves as co-investigator on the Cochrane Programme Grant supporting this review.

Gemma Whiteley: none.

Caroline Mulvaney: none.

Sources of support

Internal sources

  • The review authors declare that no funding was received for this protocol, Other.

External sources

  • Alison Rushton, Nathan Halcovitch, Timothy Gatheral, Gemma Whiteley declare that no such funding was received for this review, Other.

  • David Evans, UK.

    National Institute for Health Research: Evidence to guide care in adults and children with asthma, 13/89/14

Differences between protocol and review

In the original protocol, we stated that "If a study uses more than one scale to report the same outcome, or if different scales were used across studies, we will analyse them together using the standardised mean difference." For quality of life outcomes reported on different scales across individual studies, we reported outcomes separately, as combining scales using the standardised mean difference would be clinically difficult to interpret.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ayres 1996

Methods

Study design: randomised, open-label, parallel-group: 2 groups, self-management plan (SM) and doctor-managed (DM).

Total duration of study: 24 ± 2 weeks.

Details of any 'run-in' period: not reported.

Number of centres and locations: hospitals and general practice centres, UK; no further details.

Study setting: primary and secondary care.

Withdrawals: 1 did not receive treatment following randomisation. 32 discontinued treatment and were withdrawn (22 in SM group, 10 in DM group). Participants were withdrawn for the following reasons: non-compliance (SM 8; DM 4); asthma deterioration (SM 3; DM 3); pregnancy/lack of contraception (SM 2); excluded medication (SM 2); adverse events (SM 5; DM 1); and other (SM 2; DM 2).

Date of study: not reported.

Participants

Number of participants: 126. Full analysis SM 61, DM 64. Per-protocol analysis SM 21, DM 29.

Mean age: in years. Full analysis SM 44 ± 2, DM 47 ± 2. Per-protocol analysis SM 42 ± 3, DM 50 ± 3.

Age range: not reported.

Gender: full analysis SM M/F 23/38, DM M/F 28/36. Per-protocol analysis SM M/F 7/14, DM M/F 13/16.

Severity of condition: nocturnal awakening despite use of inhaled prophylactic therapy (inhaled corticosteroids 400 to 1600 μg·day-1, sodium cromoglycate or nedocromil sodium) for a minimum of 3 months.

Diagnostic criteria: documented increase (≥ 15%) in FEV1 following inhalation of a β2-agonist and/or documented diurnal variation in PEF (≥ 15%).

Baseline lung function (% potential normal PEF on prophylaxis): full analysis self-managed 79%; full analysis doctor-managed 72%.

Smoking history: not reported.

Study inclusion criteria: aged 17 years or older, with a documented increase (≥ 15%) in FEV1 following inhalation of a β2-agonist and/or documented diurnal variation in PEF (≥ 15%) plus ≥ 1 documented exacerbation of asthma in the previous 6 months that required contact with a doctor/nurse. Patients had disturbed sleep (which included early morning awakening due to asthma) on at least 3 nights in the week before enrolment into the study despite use of inhaled prophylactic therapy (inhaled corticosteroids 400 to 1600 µg·day-1, sodium cromoglycate or nedocromil sodium) for a minimum of 3 months.

Study exclusion criteria: use of LABA, anticholinergics, corticosteroids (other than by the inhaled route) within the past 4 weeks; routine/regular use of a Turbohaler® in the 6 months before entry; respiratory tract infection at, or within 2 weeks of, entry; significant disease that could have interfered with the study; pregnancy, lactation or lack of adequate contraception; and previous participation in the study or participation in any other clinical study in the 6 months before entry.

Interventions

Intervention: written guidelines on how to adjust budesonide dose on the basis of morning PEF measurements (best of 3 attempts before terbutaline use) as a percentage of their "normal" PEF.

Comparison: dose adjusted by investigator at clinic.

Concomitant medications and excluded medications: Participants received budesonide (Turbohaler® 200; Astra: 200, 400 or 800 μg BID).

Outcomes

Primary outcomes: number of sleep-disturbed nights due to asthma.

Secondary outcomes: lung function (PEF); asthma symptom scores and activity assessments; hospitalisation due to exacerbations;

4 visits to clinic at 6 ± 1 weekly intervals.

Notes

Funding for trial: Astra Pharmacuticals Ltd, UK.

Notable conflicts of interest of trial authors: not reported.

Correspondence with trial authors: none.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient details provided.
Allocation concealment (selection bias)Unclear riskInsufficient details provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible to blind participants (self-management of budesonide vs doctor-managed). Not possible to blind personnel (but sleep disturbance, daytime symptoms and activity scores unlikely to be influenced by lack of blinding).
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes and lung function and medication usage likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias)
All outcomes
High riskOne hundred twenty-six participants were randomised into the study. One hundred twenty-five participants received treatment and were included in the analysis. Fifty participants completed the study without violating the protocol and were included in the per-protocol analysis. Demographic characteristics of participants for both analyses are presented in Table 1. Thirty-two participants discontinued treatment and were withdrawn from the study - 22 in the SM group and 10 in the DM group.
Selective reporting (reporting bias)Unclear riskProtocol not available.
Other biasLow riskAppears to be free of other sources of bias.

Baldwin 1995

Methods

Study design: randomised, parallel-group, open-label.

Total duration of study: approximately 9 months.

Details of any 'run-in' period: not reported.

Number of centres and location: 1 urban general practice in North Staffordshire, UK.

Study setting: general practice/primary care.

Withdrawals: none.

Date of study: not reported.

Participants

Number of participants: 50 (25 in each group).

Mean age: not reported (aged 17 to 39 years: 26 (verbal 11, written 15); aged 40 to 59 years: 16 (verbal 9, written 7); aged 60 to 70 years: 8 (verbal 5, written 3)).

Age range: 17 to 74 years.

Gender: M 23, F 37 (verbal M 10, F 15; written M 13, F 12).

Severity of condition: PEF less than 75% of predicted value.

Diagnostic criteria: diagnosis of asthma based on detailed history and presence of PEF below 75% of predicted value.

Baseline lung function: verbal: highest PEF 350 L/min; written: highest PEF 335 L/min.

Smoking history: current smokers: 7 (verbal 4, written 3); ex-smokers: 15 (verbal 6, written 9); non-smokers: 28 (verbal 15, written 13).

Study inclusion criteria: patients registered with the practice with a diagnosis of asthma and PEF less than 75% of predicted value.

Study exclusion criteria: illiteracy, pregnancy, history of occupational asthma, chronic lung disease other than asthma and heart disease.

Interventions

Intervention: written instructions on asthma management in the form of a management plan, instruction in the use of Mini-Wright® peak flow meters.

Comparison: verbal instructions on asthma management, instruction in the use of Mini-Wright® peak flow meters.

Concomitant medications and excluded medications: not reported.

Outcomes

Primary outcomes: lung function measured on 3 occasions in clinic at 3-month intervals; objective assessment of inhaler technique via a 5-point scoring system (based on highest PEF score, PEF variability score, bronchodilator use, nocturnal symptoms, lifestyle, additional medication); number of home visits, emergency admissions or attendances at hospital for exacerbations of asthma (12 months before the study and for subsequent 12 months) noted but not reported; medication recorded at start and finish of the study period (primary outcome not stated).

Secondary outcomes: Distinction between primary and secondary outcomes was not made/reported.

Notes

Funding for trial: not reported.

Notable conflicts of interest of trial authors: not reported.

Correspondence with trial authors: requested data on number of participants requiring admission/ED visit, reported by group (verbal or written). Pending response.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskParticipants assigned to study groups by random number generation. No further information provided.
Allocation concealment (selection bias)Unclear riskInsufficient details provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of personnel and participants not performed (not practical/feasible).
Blinding of outcome assessment (detection bias)
All outcomes
High risk"assessment was made by another doctor, instructions given and PEF recorded. To avoid bias, the assessor was unaware of scores given at successive visits". However, doctor would be aware of the group to which a participant was assigned.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskStudy does not report drop-outs or number of participants on whom the data were based.
Selective reporting (reporting bias)Unclear riskStudy protocol not available. It would appear that all intended outcomes have been reported, apart from the second clinic visit assessment interval.
Other biasLow riskThe 2 groups were imbalanced in terms of the severity of asthma at baseline. This study was used to test the validity of the Midland Thoracic Society measure of morbidity scale (BMJ 1995;310:255). Although this scale features objective measures such as drug use and peak flow, it also features subjective measures such as "nocturnal symptoms in the week before the clinic visit (seven items); symptoms affecting lifestyle since the last clinic visit (six items)". Participant recall since last clinic visit, 3 months before, may have influenced scores, as participants were not asked to keep diaries. However, this study did not contribute outcome data to the review.

Charrois 2006

Methods

Study design: randomised, parallel-group, open-label.

Total duration of study: 6 months.

Details of any 'run-in' period: no run-in period.

Number of centres and locations: 4 Hinton pharmacies and 1 pharmacy in Edson, Canada.

Study setting: Pharmacy/community.

Withdrawals: 7 withdrawals; 2 lost to follow-up; 9 incomplete data; 1 protocol violation.

Date of study: not reported.

Participants

Number of participants: 70.

Mean (SD) age, years: Intervention: 35.7 (10.2); control: 38.7 (10.7).

Age range: not reported.

Gender, n female/male: intervention: 19/17; control: 18/16.

Severity of condition: high risk (see inclusion criteria).

Diagnostic criteria: Canadian National Guidelines.

Baseline lung function: not reported.

Smoking history, % current smoker: intervention: 30.6; control: 29.4.

Study inclusion criteria: self-reported diagnosis of asthma; 17 to 54 years of age and considered at high risk (ED visit or hospital admission due to asthma in the previous 12 months or use of more than 2 canisters of inhaled beta2-agonist in the previous 6 months, which far exceeds the definition for asthma control as outlined by the Canadian guidelines).

Study exclusion criteria: patients not responsible for administering their own asthma medications, unable to understand English, unavailable for 6-month follow-up, did not provide written informed consent.

Interventions

Intervention: education on asthma,assessment, optimisation of drug therapy by the pharmacist and referral to an RT and/or physician as needed. Education component included instruction on all asthma medications, with focus on the development of a written action plan (PEF- and symptom-based).

Comparison: The usual care group was given an asthma education booklet and general advice as needed.

Concomitant medications and excluded medications: not reported.

Outcomes

Primary outcomes: comparison of the difference between intervention and usual care groups in terms of change in ACQ scores from baseline to 6 months; score 0 to 6 (0 indicating the best level of control, 6 indicating the poorest level of control); improvement of 0.5 or more points considered clinically significant.

Secondary outcomes: comparisons between intervention and usual care groups in terms of numbers of ED visits and hospital admissions, use of inhaled corticosteroid (at baseline and at 6 months), number of courses of oral steroid, FEV1 (at baseline and at 2 and 6 months).

Notes

Funding for trial: Financial support was provided by Canadian Institutes of Health Research, Institute of Health Economics, University Hospital Foundation and ASTHMA Study (Alberta Strategy to Help Manage Asthma).

Notable conflicts of interest of trial authors: not reported.

Correspondence with trial authors: not required.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation accomplished through an internet randomisation service (EPICORE)
Allocation concealment (selection bias)Low riskRandomisation accomplished through an internet randomisation service (EPICORE)
Blinding of participants and personnel (performance bias)
All outcomes
High riskNo participant blinding evident; pharmacists providing PAAPs not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUnclear whether respiratory technicians, who performed the assessments, were blinded to the group.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants except 1 (protocol deviation) in the intervention group included in the analyses.
Selective reporting (reporting bias)Low riskAll outcomes listed in the protocol reported.
Other biasHigh riskStudy authors state that pharmacist compliance with the intervention was poor. Only 3/4 in the intervention group received a WAAP. Less than half of participants received education about WAAP at each pharmacy visit. Education provided for intervention and comparator groups may have been subtly different.

Cowie 1997

Methods

Study design: randomised, parallel-group (3), single-blind (assessor blinded).

Total duration of study: 6 months.

Details of any 'run-in' period: no run-in period.

Number of centres and location: Calgary, Canada.

Study setting: secondary care.

Withdrawals: 11 withdrew or were lost to follow-up.

Date of study: not reported.

Participants

Number of participants: 151 (139 completed the study).

Mean (SD) age, years: peak flow plan: 39.1 (14.41); symptom plan: 36.8 (16.50); no plan: 36.4 (12.76).

Age range: not reported.

Gender, n M/F: peak flow plan: 29/17; symptom plan: 25/20; no plan: 29/19.

Severity of condition: patients who had received urgent treatment for asthma in the previous 12 months; moderate to severe.

Diagnostic criteria: not reported.

Baseline lung function - % predicted FEV1 (SD): peak flow plan: 82 (20.5); symptom plan: 79 (18); no plan: 78 (21.3).

Smoking history: not reported.

Study inclusion criteria: history of receiving urgent treatment for asthma in the previous 12 months.

Study exclusion criteria: patients with written asthma plans.

Interventions

Intervention: symptom-based action plan or peak flow-based action plan.

Comparison: no action plan.

Concomitant medications and excluded medications: not reported.

Outcomes

Primary outcomes: attendance for urgent treatment of asthma.

Secondary outcomes: asthma control.

Notes

Funding for trial: not reported.

Notable conflicts of interest of trial authors: not reported.

Correspondence with trial authors: not required.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation achieved by use of 3 lists of random numbers, combined in database and indexed in ascending order.
Allocation concealment (selection bias)Low riskAllocation concealed using 150 sequentially numbered sealed envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible to blind participants and personnel owing to the nature of the intervention.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBaseline interview, spirometry and education performed before consent and randomisation. Research assistants who performed telephone interview 6 months after enrolment blinded to participant allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly 11 of 150 participants lost to follow-up and loss to follow-up equally distributed across groups.
Selective reporting (reporting bias)High riskPrimary outcome - comparison between groups regarding degree of asthma control and attendance for urgent treatment of asthma. Latter reported. However, data regarding asthma control not presented: night-time waking, reliever use, self-rating of asthma severity, daily dose of IHC or prednisolone course.
Other biasLow riskNone identified.

Griffiths 2004

Methods

Study design: cluster randomised controlled trial, open-label (analysis blinded).

Total duration of study: 1 year.

Details of any 'run-in' period: no run-in period.

Number of centres and locations: 44 general practices in 2 boroughs in east London.

Study setting: primary care.

Withdrawals: primary outcome data available for 319/324 (98%) participants.

Date of study: not reported.

Participants

Number of participants: 324.

Mean (SD) age: intervention: 22.9 (17.4); control: 22.2 (18.1).

Age range: aged 4 to 60 years.

Gender, n male (%): intervention: 85 (49); control: 76 (51).

Severity of condition: acute asthma requiring attendance at hospital or general practitioner out of hours service.

Diagnostic criteria: not reported.

Baseline lung function: not reported.

Smoking history (in patients > 16 years only), n smoker (%): intervention: 26 (31); control: 24 (35).

Study inclusion criteria: patients who attended hospital or GP practice for acute asthma and with sufficient understanding to follow a self-management plan.

Study exclusion criteria: not reported.

Interventions

Intervention: participant review in a nurse-led clinic and liaison with general practitioners and practice nurses comprising educational outreach, promotion of guidelines for high-risk asthma and ongoing clinical support; participants with sufficient understanding provided with a peak flow meter, a supply of rescue oral corticosteroids for future use and a written plan produced by the National Asthma Campaign with standard thresholds for peak flow and symptoms.

Comparison: Control practices received a visit promoting standard asthma guidelines; control participants were checked for inhaler technique.

Concomitant medications and excluded medications: not reported.

Outcomes

Primary outcomes: percentage of participants receiving unscheduled care for acute asthma over 1 year.

Secondary outcomes: rates of attendance for unscheduled care and review, self-management behaviour, quality of life, assessed by generic (EQ-5D) and respiratory-specific (AQ20
and north of England) scales.

NotesStudy authors contacted for disaggregated data. Study author (Dr. Griffiths) replied just before submission of the review to say that the data could potentially become available pending a data sharing agreement that was being set up. Data to be included in subsequent update of review if available owing to lack of time remaining on the grant.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskForty-four GP practices randomised via a minimisation programme - stratifying by partnership size and other criteria.
Allocation concealment (selection bias)Unclear riskInsufficient details provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskCluster randomised trial. Blinding not feasible.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskResearchers blinded to randomisation status of each practice extracted data from written and computerised participant records from both primary and secondary care. A research officer removed any specialist nurse letters to maintain blinding. Completeness and accuracy of extraction was validated by another blinded researcher, who checked 10 sets of records, using random numbers.
Incomplete outcome data (attrition bias)
All outcomes
Low riskResearchers were able to extract health record data for most participants recruited (98%).
Selective reporting (reporting bias)Unclear riskAbstract only. Protocol not available.
Other biasUnclear riskControl group included a higher percentage of participants who were fluent in English (89% vs 81%). Although randomisation resulted in equal groups at a practice level, this resulted in more participants recruited from intervention practices than from control (n = 175 vs n = 149).

Hoskins 1996

Methods

Study design: cluster randomised controlled trial.

Total duration of study: 6 months.

Details of any 'run-in' period: no run-in period.

Number of centres and locations: 290 GP practices in the UK that participated in the second national audit on asthma attacks (1991-1992).

Study setting: primary care.

Withdrawals: NA.

Date of study: 1993.

Participants

Number of participants: 290 GP practices randomised; data from 906 participants useable.

Mean age: not reported.

Age range: not reported.

Gender: not reported.

Severity of condition: exacerbation in previous 3 months.

Diagnostic criteria: not reported.

Baseline lung function: not reported.

Smoking history: not reported.

Study inclusion criteria: asthma exacerbation in previous 3 months.

Study exclusion criteria: not reported.

Interventions

Intervention: 3-step self-management plan consistent with BTS guidelines.

Comparison: usual care; no plan.

Concomitant medications and excluded medications: not reported.

Outcomes Outcomes: exacerbation resulting in hospital admission; exacerbation resulting in emergency department visit; patient-initiated GP consultation for asthma; GP asthma review consultation; course of oral steroids or use of emergency nebulised bronchodilator for asthma (each assessed at 6 months).
Notes

Funding for trial: an educational grant from Allen and Hanburys Limited.

Notable conflicts of interest of trial authors: not reported.

Correspondence with trial authors: not required.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskGeneral practitioners in the UK who had participated in the second national audit of asthma attacks in 1992-1993 were randomised (1:1) into intervention and control groups through a predetermined random numbers sequence; however, study authors do not say how random number sequence was generated.
Allocation concealment (selection bias)Unclear riskInsufficient details provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskGP not blinded to which group his/her patients were allocated; participants knew which group they were in (if made aware of the study).
Blinding of outcome assessment (detection bias)
All outcomes
High riskGeneral practitioners who participated in this study were a self-selected group with an interest in audit. Participants were likely to have shown enthusiasm and commitment and encouraged their patients to follow plans in an attempt to reduce morbidity. Six months later, both groups of doctors were invited to complete a morbidity questionnaire for each patient recruited. GP completed questionnaire on outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High riskData were reported for only 51% of GPs in the intervention group vs 83% of those in the comparator group.
Selective reporting (reporting bias)Unclear riskStudy protocol not available. All outcomes listed in Methods section reported in Results section.
Other biasHigh riskDespite randomisation, measures of patient morbidity in the intervention group before the issue of self-management plans were much higher than in the control group. A plausible explanation is that general practitioners in the intervention group elected to issue plans to patients with uncontrolled asthma, rather than to all patients who were eligible to receive them. No data on number of patients that GPs enrolled into the study, only data on number of patients for whom GPs returned questionnaires and how many of these were useable.

Jones 1995

Methods

Study design: randomised, parallel-group (2), open-label (analysis blinded).

Total duration of study: 6 months.

Details of any 'run-in' period: no run-in period.

Number of centres and locations: 25 general practices in the Wessex region (UK).

Study setting: primary care.

Withdrawals: 55 participants failed to complete the study.

Date of study: August 1990 to February 1992.

Participants

Number of participants: 127 randomised; 72 completed the study.

Mean (SD) age, years: intervention: 30.4 (11.5); control: 28.6 (7.0).

Age range: not reported.

Gender, n M/F: intervention: 14/19; control: 13/26.

Severity of condition: not stated.

Diagnostic criteria: not stated.

Baseline lung function - % predicted FEV1 (SD): intervention: 85.1 (20.8); control: 80.2 (19.9).

Smoking history, % non/passive/smoker: intervention: 55/15/30; control: 36/26/38.

Study inclusion criteria: aged 15 to 40 years; use of metered dose steroid inhaler (dose < 1001 micrograms per day, or dry powder equivalent).

Study exclusion criteria: patients on regular oral steroids; patients already possessing and regularly using a peak flow meter.

Interventions

Intervention: written self-management plan, peak flow-based.

Comparison: usual care.

Concomitant medications and excluded medications: not reported.

Outcomes

Primary outcomes: lung function, quality of life (at 6 months vs baseline).

Secondary outcomes: days lost from work or school (comparing 4 weeks before baseline and visits at 6 months); interference with daily life; symptom scores; bronchodilator use.

Notes

Funding for trial: The study was funded by a grant from Allen and Hanburys.

Notable conflicts of interest of trial authors: not reported.

Correspondence with trial authors: not required.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomisation to a self-management group or a planned visit group stratified by centre in blocks of 6. Insufficient details.
Allocation concealment (selection bias)Unclear riskNo details of allocation sequence concealment given.
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible to blind participants or practice staff.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information on who extracted data on medical resource use and prescribing data from medical records. However, personnel undertaking analysis blinded to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
High riskMean group symptom scores not presented for each of the review intervals. No patient flow diagram presented - 127 recruited, 72 completed. 30% dropped out but not clear how many were lost to each group nor losses at each review point. Quality of life data not clearly presented.
Selective reporting (reporting bias)High riskMean symptom scores at measurement intervals not presented. Uncertain what the "Time to first symptom" equates to. Very little reference made to quality of life data.
Other biasLow riskAppears to be free of other bias.

Klein 1998

Methods

Study design: randomised, parallel-group (2), open-label.

Total duration of study: 2 years.

Details of any 'run-in' period: no run-in period.

Number of centres and location: Department of Pulmonary Medicine of a teaching hospital (1100 beds) in Enschede, the Netherlands.

Study setting: tertiary care.

Withdrawals: year 1: 6 lost to follow-up, 1 death; year 2: 1 death.

Date of study: August 1995 to April 1996.

Participants

Number of participants: 245 randomised.

Mean (SD) age, years: intervention: 43.5 (11.7); control: 45.2 (12.0).

Age range: not reported.

Gender, n M/F: intervention: 51/72; control: 60/62.

Severity of condition: stable asthma with continuous use of inhaled steroids (> 200 micrograms per day metered dose inhaler).

Diagnostic criteria: European Respiratory Society.

Baseline lung function, % predicted FEV1 (SD): intervention: 76 (20); control: 76.9 (20.1).

Smoking history, % non/ex/current: intervention: 54.4/35.8/9.8; control: 51.7/35.2/13.1.

Study inclusion criteria: between the ages of 18 and 65;continuous use of inhaled steroids (≥ 200 mg/d by metered dose inhaler (MDI) or400 mg/d by dry powder inhaler) for ≥ 3 months; in a stable phase of disease during last 6 weeks, defined as no use of short courses of oral steroids or no increase in maintenance dose of oral steroids; ability to speak and read the Dutch language.

Study exclusion criteria: not stated.

Interventions

Intervention: asthma nurse-led education plus written self-management plan (peak flow- and symptom-based).

Comparison: asthma nurse-led education, no plan.

Concomitant medications and excluded medications: not reported.

Outcomes Primary outcomes: pulmonary function at baseline and at 4, 8, 12, 18 and 24 months after entry (pre-bronchodilator FEV1 (% predicted) and from 2-week diaries mean morning pre-bronchodilator PEF and mean diurnal PEF variability together with PC20 histamine at baseline and at 12 months); asthma morbidity parameters (frequency of exacerbations at baseline and at 4, 8, 12, 18 and 24 months; use of healthcare facilities during the year before and the first and second years after the intervention (numbers of outpatient visits, hospitalisations and hospital days).
Notes

Funding for trial: Netherlands Asthma Foundation (Grant 94-52), GlaxoWellcome, the "StichtingAstmabestrijding" and Amicon Health Care Insurance Fund.

Notable conflicts of interest of trial authors: not reported.

Correspondence with trial authors: not required.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information provided.
Allocation concealment (selection bias)Low riskRemaining 245 participants randomised into a self-treatment group (group S) and a control group (group C) by a closed envelope method.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not possible and outcomes possibly influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information provided to make a judgement.
Incomplete outcome data (attrition bias)
All outcomes
Low riskFew drop-outs baseline to 12 months, greater number of drop-outs 12 months to 24 months. However, 12-month data can be examined separately from 24-month data. Study extended from original 1-year plan to 2 years after commencing. High drop-out rates going into year 2 - mainly younger people. Potential to skew data.
Selective reporting (reporting bias)Low riskAppears that all prespecified outcomes in Methods section have been reported in Results section. Some outcomes (e.g. perceived control of asthma, self-confidence) reported only for the 1-year interval - not at 2 years.
Other biasLow riskAppears to be free of other sources of bias.

McArdle 1997

Methods

Study design: randomised, parallel-group (2), open-label.

Total duration of study: 6 months.

Details of any 'run-in' period: no run-in period.

Number of centres and location: single outpatient clinic of large inner city hospital, Australia.

Study setting: secondary care.

Withdrawals: data reported for 41/45 randomised participants; reasons for loss not reported.

Date of study: not reported.

Participants

Number of participants: 45 participants randomised.

Mean age: not reported (abstract only).

Age range: not reported (abstract only).

Gender: not reported (abstract only).

Severity of condition: not reported (abstract only).

Diagnostic criteria: not reported (abstract only).

Baseline lung function: not reported (abstract only).

Smoking history: not reported (abstract only).

Study inclusion criteria: patients with a diagnosis of asthma .

Study exclusion criteria: not reported (abstract only).

Interventions

Intervention: generalised asthma education plus written asthma action plan (peak flow-based).

Comparison: generalised asthma education only.

Concomitant medications and excluded medications: not stated (abstract only).

Outcomes

Primary outcomes: adherence to plan.

Secondary outcomes: symptom score.

Notes

Funding for trial: not reported (abstract only).

Notable conflicts of interest of trial authors: not reported (abstract only).

Correspondence with trial authors: trial authors contacted for more detailed data not presented in the abstract. Trial authors agreed to search for data on return to office; no further contact.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient details provided.
Allocation concealment (selection bias)Unclear riskInsufficient details provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding would not be feasible.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient details provided.
Incomplete outcome data (attrition bias)
All outcomes
Low riskData reported for 91% of participants.
Selective reporting (reporting bias)Unclear riskStudy protocol not available.
Other biasLow riskNone identified.

Milenković 2007

Methods

Study design: prospective, randomised, parallel-group (2), open-label trial.

Total duration of study: 12 months (additional follow-up at 5 years).

Details of any 'run-in' period: 2 weeks; ability of participants in the self-management group to measure peak expiratory values evaluated.

Number of centres and locations: outpatient departments of 2 tertiary reference clinics in Serbia.

Study setting: tertiary care (outpatient).

Withdrawals: 6 participants dropped out (3 from each group).

Date of study: Patients entered the trial at staggered intervals from September 1999 to September 2000.

Participants

Number of participants: 80 randomised participants.

Mean (SD) age, years: intervention: 49.1 (14.4); control: 44.9 (11.7).

Age range: not reported.

Gender, n M/F: intervention: 17/20; control: 18/19.

Severity of condition, % mild/moderate/severe: intervention: 51/35/14; control: 54/35/16.

Diagnostic criteria: "The diagnosis was confirmed and treatment prescribed according to the national and international asthma guidelines".

Baseline lung function - mean (SD) FEV1, L: intervention: 2.47 (0.78); control: 2.48 (0.55).

Smoking history, % never/ex/current: intervention: 75/25/0; control: 70/30/0.

Study inclusion criteria: age between 18 and 60 years; continuous use of inhaled steroids for at least last 1 year; stable phase of disease during last 3 months.

Study exclusion criteria: smoking history of 15 or more pack-years; other diseases that could influence bronchial symptoms and/or lung function.

Interventions

Intervention: individual written action plan based on peak flow measurements.

Comparison: usual care; no peak flow meter. Participants were instructed to take reliever medication if their asthma symptoms deteriorated and to seek advice from their primary care physician regarding controller medication.

Concomitant medications and excluded medications: not reported.

Outcomes Outcomes: lung function; number of asthma exacerbations; number of hospital admissions; number of unscheduled visits (including visits to emergency department, general practitioner or pulmonologist); treatment requirements during asthma exacerbations (courses of doubling dose of inhaled corticosteroids, use of oral prednisolone and antibiotics); days off work because of asthma exacerbations and asthma symptoms.
Notes

Funding for trial: not reported.

Notable conflicts of interest of trial authors: not reported.

Correspondence with trial authors: none required.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient details provided.
Allocation concealment (selection bias)Unclear riskInsufficient details provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskUnlikely that blinding possible.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutpatient visits scheduled every 6 months - clinical state and course of treatment evaluated by a physician as per routine clinical practice. Insufficient information provided to make a judgement.
Incomplete outcome data (attrition bias)
All outcomes
Low risk40 participants randomised to each group. Attrition of 3 participants per group by 1-year interval (37 vs 37).
Selective reporting (reporting bias)Unclear riskStudy protocol not available.
Other biasLow riskNone identified.

Nokela 2010

Methods

Study design: cluster randomised trial.

Total duration of study: 14 weeks.

Details of any 'run-in' period: none.

Number of centres and locations: 19 primary healthcare centres in the Stockholm area.

Study setting: primary health care.

Withdrawals: 11 participants in the control group and 10 in the intervention group were lost to follow-up for unknown reasons. One participant in the intervention group did not meet the age inclusion criteria and was therefore excluded. Three controls and 2 participants in the intervention group completed the second visit much later than planned in the protocol (20 to 32 weeks overdue) and were therefore excluded. Thus, 64 participants in the intervention group and 77 in the control group completed the study.

Date of study: From October 2003 until December 2004.

Participants

Number of participants: 141.

Mean age (range), years: intervention: 48 (19 to 87); control: 52.5 (18 to 79).

Age range: 18 to 87 years.

Gender, n F/M: 98/43.

Severity of condition: not reported.

Diagnostic criteria: 'asthma diagnosis'.

Baseline lung function - mean (min, max) % predicted FEV1, L: intervention: 89 (33, 127); control:82.6 (5, 118).

Smoking history - current/ex/never, %: intervention: 14/45/41; control: 18/40.3/40.3 (1.3% missing data).

Study inclusion criteria: Centres were instructed to consecutively invite all eligible patients with an asthma diagnosis who sought medical attention (for any condition) to participate.

Study exclusion criteria: age < 18 years; poor understanding of written Swedish; malignant disease; severe psychiatric disease and dementia.

Interventions

Intervention: provision of additional structured written and oral information (symptom-based plan), follow-up using an asthma diary.

Comparison: according to local treatment routine.

Concomitant medications and excluded medications: not reported.

Outcomes

Primary outcomes: change in score on the asthma control questionnaire (ACQ) between the 2 visits in the study. (Minimum important difference ˜0.5.)

Secondary outcomes: lung function measurements (FEV1 or PEF), number of self-reported emergency visits caused by asthma, number of participants with additional/unanswered questions about their asthma or its management, prescribed changes in drug treatment, patient-perceived benefit of asthma medications, costs of asthma medications, changes in disease-specific quality of life. Disease-specific quality of life was measured using the validated Swedish version of the Mini Asthma Quality of Life Questionnaire (Mini-AQLQ; MCID 0.5), which yields a total score between 1 and 7, where 7 is the best and 1 is very poor.

Notes

Funding for trial: Study was supported and funded by drug and therapeutics committees in Stockholm and Sörmland, the Stockholm County Council, the Vårdal Foundation and the Karolinska Institutet.

Notable conflicts of interest of trial authors: none reported.

Correspondence with trial authors: not required.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation was performed with a computer programme that generated random numbers.
Allocation concealment (selection bias)Unclear riskInsufficient details provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not possible owing to the nature of the intervention.
Blinding of outcome assessment (detection bias)
All outcomes
High riskAssessors aware of allocation throughout.
Incomplete outcome data (attrition bias)
All outcomes
High risk> 85% follow-up. 11 control, 10 intervention participants lost to follow-up - reasons unknown. Lung function reported in records for 100% of Intervention participants (64) and only 91% of control participants (77). Also, study authors reported mean (SD) point change in outcome measure between first and second visits - actual data not presented.
Selective reporting (reporting bias)Unclear riskStudy protocol not available.
Other biasUnclear riskMore smokers in control group (14 vs 9).

Sangha 2004

Methods

Study design: randomised, parallel-group (2), open-label.

Total duration of study: 6 months.

Details of any 'run-in' period: not reported (abstract only).

Number of centres and locations: not reported (abstract only).

Study setting: not reported (abstract only).

Withdrawals: not reported (abstract only).

Date of study: not reported (abstract only).

Participants

Number of participants: 100.

Mean age: not reported (abstract only).

Age range: not reported (abstract only).

Gender: not reported (abstract only).

Severity of condition: not reported (abstract only).

Diagnostic criteria: not reported (abstract only).

Baseline lung function: not reported (abstract only).

Smoking history: not reported (abstract only).

Study inclusion criteria: diagnosis of bronchial asthma.

Study exclusion criteria: not reported (abstract only).

Interventions

Intervention: education plus peak flow-based written action plan.

Comparison: education.

Concomitant medications and excluded medications: not reported (abstract only).

Outcomes

Primary outcomes: lung function parameters at 6 months.

Secondary outcomes: 'morbidity data'.

Notes

Funding for trial: not reported (abstract only).

Notable conflicts of interest of trial authors: not reported (abstract only).

Correspondence with trial authors: study authors contacted for further data/information. No response at time of submission.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient details provided.
Allocation concealment (selection bias)Unclear riskInsufficient details provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not feasible.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient details provided.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient details provided.
Selective reporting (reporting bias)Unclear riskProtocol not available.
Other biasLow riskNone identified (abstract only).

Sheares 2015

Methods

Study design: randomised, parallel-group (2), open-label.

Total duration of study: 12 months.

Details of any 'run-in' period: no run-in period.

Number of centres and locations: 7 pulmonary and allergy practices at 4 urban medical centres.

Study setting: secondary care.

Withdrawals: 7 withdrawals; 10 relocations; 67 lost-to follow-up.

Dates of study: 2006-2009.

Participants

Number of participants: 407 participants randomised. 135 adults (33%) and 272 children (67%).

Mean age: not reported.

Age range: not reported.

Gender, n female (%): intervention: 188 (92); control: 175 (86).

Severity of condition: persistent asthma as defined by NAEPP guidelines.

Diagnostic criteria: NAEPP guidelines.

Baseline lung function: not reported.

Smoking history: not reported.

Study inclusion criteria: children and adults aged 5 to 80 years with a physician diagnosis of persistent asthma (as defined by NAEPP guidelines).

Study exclusion criteria: diagnosis of a comorbid condition affecting lung health.

Interventions

Intervention: written asthma action plan.

Comparison: usual care (no written asthma action plans).

Concomitant medications and excluded medications: not reported.

Outcomes

Primary outcomes: asthma symptom frequency, emergency visits, asthma quality of life (mini-AQLQ score); each at 12 months.

Secondary outcomes: participant use of WAAP.

Notes

Funding for trial: supported by the NIH/NHLBI (grant R01HL73955) and the National Center for Advancing Translational Sciences, NIH (UL1 TR000040), formerly the National Center for Research Resources (UL1 RR024156).

Notable conflicts of interest of trial authors: none.

Correspondence with trial authors: trial authors contacted with request for mean age of cohort. No response at time of submission.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random number sequence was used for randomisation. "we used a randomised block, mixed-effects factorial design"..."Blocks were of variable sizes to eliminate predictability".
Allocation concealment (selection bias)Low riskAllocation was concealed in sealed numbered envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskDouble-blinding was not possible. However, a randomised block design with physician as a random factor was used to minimise variability due to physician. "The intervention group had a blank WAAP form inserted into their charts and the control group had no WAAP form, but a sticker was applied to the outside of the chart to remind physicians to provide their usual instructions without giving any written materials other than prescriptions".
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information provided to make a judgement. Presumably, research staff interviewed participant following physician appointment. Unclear whether staff were blinded to participant group allocation. "After the initial visit, participants were interviewed via telephone by staff from the New England Research Institute (Watertown, MA) every 3 months during the 12-month follow-up period". Presumed research institute staff blinded to group allocation but study authors do not state this.
Incomplete outcome data (attrition bias)
All outcomes
High riskNo one was excluded from the analysis other than for reason of missing data. A relatively high percentage of randomised participants were excluded from analyses for missing data; inverse proportions of adults/children were recruited to intervention and control groups. More children in the Intervention group. More participants lost to follow-up in the intervention group (24%) compared with the control group (18%).
Selective reporting (reporting bias)Low riskComparison with NCT website demonstrates that all comparisons were reported.
Other biasUnclear riskStudy included both adults and children, so we need to seek disaggregated data. More children in the intervention group.

Thoonen 2001

Methods

Study design: cluster randomised controlled trial.

Total duration of study: 2 years.

Details of any 'run-in' period: none.

Number of centres and locations: 19 general practices were recruited from 2 pools; the first were in and around the city of Eindhoven, and the second included practices from our department’s academic research network; Netherlands.

Study setting: primary care.

Withdrawals: 43.

Date of study: not reported.

Participants

Number of participants: 214.

Mean (SD) age, years: intervention: 39.6 (11.2); control: 39.3 (12.0).

Age range: not reported.

Gender, n M/F: intervention: 34/64; control: 40/56.

Severity of condition: FEV1 > 40% predicted and > 55% predicted 15 minutes after salbutamol.

Diagnostic criteria: not reported.

Baseline lung function - mean (SD) % predicted FEV1 pre-BD, L: intervention: 84.0 (13.1); control: 86.9 (14.2).

Smoking history, % never/former/current: intervention: 46/32/22; control: 56/22/22.

Study inclusion criteria: treated for asthma by GP; age 16 to 60 years; FEV1 > 40% of predicted value and > 55% of predicted value 15 minutes after inhalation of 800 µg salbutamol or 6 weeks after inhalation of 800 µg budesonide twice daily; FEV1 reversibility (after bronchodilation with 800 µg salbutamol metered dose inhaler or 8 weeks treatment with 800 µg budesonide twice daily) of at least 10% of predicted value or PC20 histamine of 8 mg/mL.

Study exclusion criteria: smoking history of 15 or more pack-years; serious diseases other than asthma with low survival rates; exacerbations during the month before the start of the study; other diseases that influence bronchial symptoms and/or lung function such as heart failure, sarcoidosis; inability to inhale medication correctly or to measure and record peak flow adequately and unlikely that this can be taught.

Interventions

Intervention: written personalised asthma action plan.

Comparison: usual care according to national guidelines.

Concomitant medications and excluded medications: not reported.

Outcomes

Primary outcomes: asthma control, asthma-specific quality of life, lost activity days.

Secondary outcomes: number of puffs of budesonide, number of dose equivalents of short-acting bronchodilators, number of short courses of oral prednisolone and antibiotics, number of GP-diagnosed exacerbations.

Notes

Funding for trial: This research project has been made possible by research grants from The Netherlands Organization for Scientific Research (NWO) and ASTRAZeneca Pharmaceutica BV.

Notable conflicts of interest of trial authors: reported as 'none'.

Correspondence with trial authors: not required.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information provided.
Allocation concealment (selection bias)Unclear riskInsufficient information provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskOwing to the nature of the intervention and GP practice rather than participant randomisation, it is not possible to blind personnel and participants.
Blinding of outcome assessment (detection bias)
All outcomes
High risk"Assessors were not blinded to study group allocation".
Incomplete outcome data (attrition bias)
All outcomes
Low risk104 usual care (UC) and 110 self-management (SM) recruited - 95 UC and 98 ITT analyses. 18 participants did not complete UC arm, 25 did not complete SM arm.
Selective reporting (reporting bias)Unclear riskProtocol not available. All defined outcomes appear to have been reported.
Other biasHigh riskStudy authors noted that participants who received PAAPs were provided with an oral course of prednisolone, and that the prescription may have been incorrectly interpreted as evidence of use of prednisolone during an exacerbation.

Wang 2004

  1. a

    Abbreviations: ACQ, Asthma Control Questionnaire; A&E, accident and emergency; AQ20, Airways Questionnaire 20; AQLQ, Asthma Quality of Life Questionnaire; BTS, British Thoracic Society; DM, doctor-managed; ED, emergency department; EQ-5D, Euro quality of life five dimensions questionnaire; F, female; FEV1, forced expiratory volume in one second; GP, general practitioner; ITT, intention-to-treat; LABA, long-acting beta-agonist; M, male; MCID, minimum clinically important difference; MDI, metered-dose inhaler; Mini-AQLQ, Mini Asthma Quality of Life Questionnaire; NCT, national clinical trial; NHLBI, National Heart, Lung and Blood Institute; NIH, National Institutes of Health; NAEPP, National Asthma Education and Prevention Program; PAAP, personalised asthma action plan; PC20, provocation concentration causing a 20% fall in FEV1; PEF, peak expiratory flow; RT, respiratory technician; SD, standard deviation; SM, self-managed; UC, usual care; WAAP, written asthma action plan.

Methods

Study design: randomised, parallel-group (2), open-label.

Total duration of study: 12 months.

Details of any 'run-in' period: none.

Number of centres and location: Queen Mary Hospital, Hong Kong.

Study setting: tertiary care.

Withdrawals: 13% lost to follow-up.

Date of study: not reported (abstract only).

Participants

Number of participants: 76.

Mean age: not reported (abstract only).

Age range: not reported (abstract only).

Gender: not reported (abstract only).

Severity of condition: "acute asthma".

Diagnostic criteria: not reported (abstract only).

Baseline lung function: not reported (abstract only).

Smoking history: not reported (abstract only).

Study inclusion criteria: acute asthma.

Study exclusion criteria: not reported (abstract only).

Interventions

Intervention: asthma self-management programme with a written self-action plan and usual care.

Comparison: usual care only.

Concomitant medications and excluded medications: not reported (abstract only).

Outcomes Outcomes: ratio of asthma-related hospitalisation, A&E visits, visits to general practitioners, days off work, asthma symptoms, use of medications, lung function; all outcomes measured at 12 months.
Notes

Funding for trial: not reported (abstract only).

Notable conflicts of interest of trial authors: not reported (abstract only).

Correspondence with study authors: study authors contacted via email with request for published data or associated peer-reviewed paper. No response at time of submission.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient details provided.
Allocation concealment (selection bias)Unclear riskInsufficient details provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not feasible.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient details provided.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient details provided.
Selective reporting (reporting bias)Unclear riskProtocol not available.
Other biasLow riskNone identified (note abstract only).

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Adams 2001Wrong comparator: Study compared peak-flow- vs symptom-based plans; no control group that received no PAAP.
Araújo 2012Wrong comparator: Participants were randomly assigned to a sequence of Web-based and paper-based diary and action plan; no control group that received no PAAP.
Arguel 2013Wrong intervention: evaluation of a Web-based personally controlled health management system (PCHMS) called Healthy.me.
Bailey 1990Wrong intervention: evaluation of a workbook with 1-to-1 counselling and adherence-promoting strategies.
Bailey 1999Wrong intervention: Self-management plans did not appear to include a written action plan.
Behera 2006Wrong comparator: self-care manual, which appeared to involve an educational component (interviews), vs no manual and no education. Pilot study for Behera 2008.
Behera 2008Wrong comparator: self-care manual, which appeared to involve an educational component (interviews), vs no manual and no education. Pilot study was Behera 2006.
Berg 1996Wrong intervention: 6-week self-management programme. No specific mention of written asthma plan.
Boath 1998Wrong comparator: peak-flow-based plan vs symptom-based plan; no control group that did not receive any plan.
Breysse 2011Wrong participant population: 'asthmatic children'.
Buist 2001Wrong intervention: compares different shared decision-making models.
Calhoun 2012Wrong intervention: Participants in the intervention groups did not appear to receive a personalised written action plan.
Chenu 2000Wrong comparator: education plus PAAP vs no education and no PAAP.
Clark 2005Wrong intervention: a multiple-component behavioural education programme delivered by a nurse health educator through telephone counselling.
Cleland 2004Wrong intervention: an interactive seminar delivered at practice level.
Couturaud 2002Wrong comparator: education plus PAAP vs no education and no PAAP.
Côté 2001Wrong comparator: limited education plus PAAP vs structured education plus PAAP vs 'usual care' (no PAAP plus no education).
Espinosa 1998Wrong intervention: 'personal education for one year'.
Fernandes 2011Wrong intervention: education on inhaler technique by trained respiratory technician.
Fonseca 2006Wrong study design: participant diary vs no participant diary.
Ford 1996Wrong intervention: education vs no education; self-management group does not specify use of PAAP. Pilot study for Ford 1997.
Ford 1997Wrong intervention: education vs no education; self-management group does not specify use of PAAP. Piloted in Ford 1996.
Gaga 2004Wrong comparator: Usual care comprised specialist-directed adjustments to therapy.
Gallefoss 2001Wrong comparator: structured education plus PAAP vs no PAAP and no education.
Goeman 2013Wrong intervention: No PAAP was issued (the intervention included advice to discuss obtaining a PAAP from physician).
GRASSIC 1994Wrong comparator: self-management education plus PAAP vs no PAAP and no self-management education.
Haniotou 2012Wrong comparator: PAAP plus education/training around breathing technique vs no PAAP and no education.
Ignacio 1995Wrong comparator: Control group received PAAP.
Janson 2009Wrong comparator: education plus PAAP vs no education and no PAAP.
Kelso 1996Wrong study design: non-randomised.
Kemple 2002aWrong study design: Randomisation occurred after group allocation.
Kim 2016Wrong intervention: Intervention includes possibility of investigators directly intervening as they monitored data entered by participants into the mobile-based plan.
Kokubu 2000Wrong comparator: Both groups received a PAAP.
Kotses 1996Wrong study design: appears to be pseudo-randomised (participants randomised but with the restriction that groups were balanced for numbers).
Lahdensuo 1994Wrong intervention: Plan was not personalised.
Lahdensuo 1996Wrong comparator: PAAP plus education (therapeutic counselling by specialist nurses and relaxation/breathing techniques by physiotherapist) vs general asthma advice by specialist nurse and no PAAP.
Levy 1995Wrong comparator: PAAP plus education provided by secondary care specialist nurses at arranged consultations vs usual care in primary care setting.
Lincicome 2001Wrong participant population: paediatric participants aged 3 to 15 years.
Magar 2005Wrong comparator: PAAP plus education vs no PAAP and no education.
McLean 2003Wrong comparator: PAAP plus education vs no PAAP and no education.
NCT00129662Wrong study design: non-randomised study.
NCT00214669 2005Wrong comparator: PAAP plus education vs no PAAP and no education.
NCT01070095Wrong study design: non-randomised, single group assignment.
NCT01079000 2012Wrong comparator: Control group received PAAP.
NCT01282359Wrong comparator: PAAP plus education vs no PAAP and no education.
NCT02046759Wrong comparator: PAAP plus education vs no PAAP and no education.
NCT02091869 2014Wrong participant population: paediatric patients aged 12 to 17 years.
Olivera 2016Wrong comparator: education (and possibly PAAP) vs no education and no PAAP.
Osman 2001Wrong comparator: 30% of control group also received a PAAP.
Parkes 2012Wrong study design: non-randomised (study authors contacted and confirmed that randomised portion of study will not go ahead).
Patel 2015Wrong comparator: PAAP plus education vs no PAAP and no education.
Put 2001Wrong intervention: workbook to re-enforce education (not PAAP).
Ross 2012Wrong intervention: no reference to use of a PAAP.
Sittipunt 2008Wrong comparator: PAAP plus education vs no PAAP and no education.
Steurer-Stey 2010Wrong comparator: Control group also received a PAAP.
Tousman 2009Wrong intervention: daily tracking diary rather than a PAAP.
Tuazon 2000Wrong comparator: comparison between 2 different education programmes. Unsure about inclusion of a PAAP.
Urek 2005Wrong intervention: comparison of 3 different education approaches.
Wilson-Pessano 1987Wrong intervention: no reference to PAAP.
Zairina 2015Wrong intervention: tele-health application.

Characteristics of studies awaiting assessment [ordered by study ID]

Angelini 2010

Methods

Study design: randomised controlled trial with 3 parallel groups: control, education and self-management.

Total duration of study: 24 months.

Details of any 'run-in' period: not reported.

Number of centres and locations: not reported.

Study setting: not reported.

Withdrawals: not reported.

Date of study: not reported.

Participants

Number of participants: 84.

Mean age: not reported.

Age range: not reported.

Gender: not reported.

Severity of condition: "moderate and severe persistent asthma".

Diagnostic criteria: not reported.

Baseline lung function: not reported.

Smoking history: not reported.

Study inclusion criteria: not reported.

Study exclusion criteria: not reported.

Interventions

Intervention: educational programme consisting of lectures on pathophysiology and environmental control, asthma symptoms, treatment and training in the inhalation technique. Self-management group also received a symptoms diary card and a written personal asthma action plan.

Comparison: not reported.

Concomitant medications and excluded medications: not reported.

Outcomes

Primary outcomes: Asthma Control Test (mean score).

Secondary outcomes: Questionnaire Disease Knowledge (QDK), asthma quality of life (AQLQ-s), Hospital Anxiety and Depression Scale (HADS), functional literacy health test (s-TOFHLA). (Study authors do not distinguish between primary and secondary.)

Notes

Funding for trial: not reported.

Notable conflicts of interest of trial authors: not reported.

Correspondence with trial authors: none.

Characteristics of ongoing studies [ordered by study ID]

NCT02190617 2014

Trial name or titleGuidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation.
MethodsRandomised controlled trial, intervention study.
ParticipantsAged 5 to 75 years with a diagnosis of uncontrolled asthma; estimated enrolment 550.
Interventions1. Enhanced clinic plus unified management plan; 2. Home visit option only; 3. Enhanced clinic plus unified management plan plus home visit option.
OutcomesSymptom-free days, asthma control, asthma-related quality of life, nocturnal awakening, asthma exacerbations, pulmonary function, fractional exhaled nitric oxide, beta-agonist use, oral steroid use, controller use, emergency healthcare utilisation, days of work or school missed, general health status.
Starting dateDecember 2014.
Contact informationJames Stout, MD (Washington University).
Notes https://clinicaltrials.gov/show/NCT02190617

NCT02424409 2015

Trial name or titleEvaluation of the Relapse Rate One Month After Discharge From Emergency Department for Asthmatic Patients Given a Strict Formalized Follow up Protocol.
MethodsRandomised controlled trial, intervention study.
ParticipantsPatients over 18 years, consulting to the emergency department for an acute asthma attack, who, after initial treatment are discharged directly from the emergency department after giving free and informed consent.
InterventionsPersonalised asthma action plan (PAAP) vs no PAAP.
OutcomesRecurrence rate of any asthma attacks at 15 days and at 1 month, hospitalisation rate at 30 days, asthma control score, percentage of participants self-medicating, percentage of participants using peak flow meter, participant adherence to protocol.
Starting dateAugust 2015.
Contact informationJennifer Truchot, MD; jennifer.truchot@lrb.aphp.fr.
Notes https://clinicaltrials.gov/ct2/show/NCT02424409

Ancillary