Intervenciones para mejorar la técnica del inhalador para los pacientes con asma
References
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en espera de evaluación
Referencias de los estudios en curso
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Design: single‐blind parallel‐group randomised controlled trial Duration: 4 weeks Setting: USA Trial registration: not reported | |
| Participants | Population: 133 people with asthma randomised to an MDI inhaler technique training video or an asthma education video (n per group not reported) Age: "adults" Baseline asthma severity: not reported Inclusion criteria: "asthma patients" Exclusion criteria: not reported Percentage withdrawn: not reported per group; 17/133 (13%) did not complete trial Other allowed medication: not reported | |
| Interventions | Intervention summary: MDI training video shown at index visit with pre and post assessment of inhaler technique, with follow‐up at 1 month Control summary: asthma education video shown at index visit with pre and post assessment of inhaler technique, with follow‐up at 1 month | |
| Outcomes | Outcomes measured: "correct usage" Technique assessment method used: not reported | |
| Notes | Type of publication: conference abstract Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomized" ‐ no further details of sequence generation |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | Low risk | "The examiner (who assessed inhaler technique) was blinded to the intervention" |
| Incomplete outcome data (attrition bias) | Unclear risk | Although 116/133 (87%) participants completed the trial, the drop‐out for each arm is not reported |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified. Minimal details as reported, as conference abstract only. Unclear how "correct technique" was assessed |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: single‐blind parallel‐group randomised controlled trial Duration: 2 weeks Setting: 1 outpatient clinic in Denmark Trial registration: not reported | |
| Participants | Population: 72 children with asthma randomised to hospital and home training (n = 36) or hospital training alone (n = 36) Age: children aged 3 to 5 years; mean age 54 months (range 36 to 71 months) Baseline asthma severity: not reported Inclusion criteria: preschool children aged 3 to 5 years. All had bronchial asthma and were receiving inhaled anti‐inflammatory therapy through a pMDI and spacer Exclusion criteria: children with acute wheeze Percentage withdrawn: 0% of participants withdrew from the intervention group and 3% from the control group Other allowed medication: All children continued their regular antiasthma therapy throughout the course of the study | |
| Interventions | Intervention summary: instructional video followed by instructional pamphlet contained in the commercially available Turbuhaler package. Intervention group children then received individual training from a nurse and a placebo inhaler to practice with at home over the next 2 weeks Control summary: instructional video followed by instructional pamphlet contained in the commercially available Turbuhaler package | |
| Outcomes | Outcomes measured: lung function measures: peak inspiratory flow (PIF) and inspiratory vital capacity (IVC). Peak expiratory flow rate (PEF), forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) were measured "for demographic purposes only" Technique assessment method used: PIF was used as a measure of inhaler technique | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "At study entry, the children were stratified by age and randomly allocated to one of two study groups". It not clear how the sequence was generated for randomisation after stratification by age |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | Low risk | Children, caregivers and personnel could not be blinded owing to nature of intervention. However, given the young age of children and the objective nature of the outcome measures (lung function), it is unlikely that knowledge of group allocation had an impact on their performance, beyond the impact intended by the intervention |
| Blinding of outcome assessment (detection bias) | Low risk | The trial is described as single‐blind. "The investigator conducting all inspiratory and expiratory lung function testing was unaware of the level of training received by each child after the initial basic clinic training". In addition, lung function measures are relatively objective and are not at high risk of detection bias |
| Incomplete outcome data (attrition bias) | Low risk | Only 1 child in the control group was withdrawn from the trial by parents |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. Baseline characteristics table missing, so unable to assess baseline imbalances objectively, although text states that groups were balanced. All outcomes listed in Methods reported in the text |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 6 weeks Setting: 1 outpatient clinic, UK Trial registration: not reported | |
| Participants | Population: 108 people with asthma randomised to verbal training plus 2Tone Trainer (n = 36) or verbal training alone (n = 36) Age: mean age (SD) in the intervention group 58.3 (13.7) years, and in the control group 52.6 (16.7) years Baseline asthma severity: intervention group: FEV1 % predicted (SD) 71.4 (22.0); mini‐AQLQ (SD) 3.8 (1.1). Control group: FEV1 % predicted (SD) 76.9 (24.1); mini‐AQLQ (SD) 3.9 (1.0) Inclusion criteria: Patients with asthma who were attending an outpatient clinic were invited to take part in this study. Each patient had to be receiving an inhaled corticosteroid from an MDI without a spacer device. Patients with adequate co‐ordination but too rapid inspiratory flow were randomised to 1 of the 2 intervention groups Exclusion criteria: patients who had experienced an acute exacerbation in the past 4 weeks; patients who were deaf or unable to distinguish between 1 and 2 tones with the 2T; patients with poor inhaler co‐ordination who were ineligible for the study and were referred to the asthma nurse for inhaler technique training Percentage withdrawn: 0% of participants withdrew from the intervention group, and 3% from the control group Other allowed medication: "There were no changes to patients' prescriptions" | |
| Interventions | Intervention summary: The 2Tone Trainer looks like an MDI but does not have a canister, so that when it is used, the patient does not receive a dose. During use, this training aid provides users with audible feedback according to the patient’s inhalation rate. It makes a 2‐tone sound when the patient is inhaling at 60 L/min, 1 tone when inhaling between 30 and 60 L/min and no sound when inhaling at 30 L/min. Patients are advised to obtain the 1‐tone noise and thus become accustomed to the degree of inspiratory effort they need to make to achieve this rate through an MDI. Participants were given a 2Tone Trainer to use at home and received the same verbal training as the verbal training alone group Control summary: Verbal training participants were trained on the most desirable inhalation technique with emphasis on breathing out slowly as far as comfortable and actuating a dose at or soon after the start of a slow inhalation. A slow inhalation was defined as an inhalation that filled the lungs with air that lasted 5 seconds | |
| Outcomes | Outcomes measured: peak inspiratory flow (PIF), FEV1 and quality of life (AQLQ) Technique assessment method used: PIF was used as a measure of inhaler technique | |
| Notes | Type of publication: single peer‐reviewed journal article plus 2 conference abstracts Funding: 2Tone Trainers were donated by Canday Medical Ltd. Dr Al‐Showair was financially supported by a scholarship from the Saudi Arabian Government, and the study was part of his PhD | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Subjects in the intervention group were randomly allocated into the verbal training (VT) group or the 2T group" ‐ no further details of sequence generation |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group assignment; for outcomes such as AQLQ, the participant/caregiver is the outcome assessor; therefore these outcomes may be at risk of detection bias |
| Incomplete outcome data (attrition bias) | Low risk | Only 1 participant withdrew from the study |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. However, all outcomes listed in Methods clearly reported in paper |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 6 weeks Setting: 1 outpatient clinic, UK Trial registration: not reported | |
| Participants | Population: 56 people with asthma randomised to 2 Tone Trainer (2TT) group (n = 23; 17 adults, 6 children) or verbal counselling (VC) group (n = 23; 17 adults, 6 children). Children with adequate technique at initial assessment formed the "control" group (not of interest in this study, as not randomised) (we have assigned the 2TT as the "intervention" arm and the VC as the "control" arm) Age: 4 to 55 years; mean (SD) age in the intervention group: adults 38.5 (10.8) years, children 11.7 (2.4) years; and in the control group: adults 42.4 (7.2) years, children 11.2 (2.4) years Baseline asthma severity: "Mild‐moderate‐severe asthma, according to GINA 2008" Inclusion criteria: 4 to 55‐year‐old asthmatic patients prescribed at least 1 MDI without spacer Exclusion criteria: experienced an acute exacerbation or received oral prednisolone within 4 weeks before recruitment, other illnesses adversely affecting respiratory system, hearing problems and/or unable to distinguish between 1 and 2 tones produced by the 2TT tool Percentage withdrawn: 12% adults, 0% children withdrew from the intervention (2TT) arm; 18% adults and 17% children withdrew from the "control" (VC) arm Other allowed medication: not reported | |
| Interventions | Intervention summary: verbal training plus use of 2 Tone Trainer (2TT) device, which participants were able to take home. 2TT is a training aid with audible feedback when the required slow inhalation flow is used Control summary: verbal training with emphasis on inspiratory flow rate | |
| Outcomes | Outcomes measured: lung function measures: change in FEV1; inhalation flow rate; QOL: Juniper's Asthma QOL Questionnaire (AQLQ): adults ‐ Mini AQLQ; children ‐ PAQLQ; PACQLQ by parents of children Technique assessment method used: PIF was used as a measure of inhaler technique | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "…based on a previously constructed randomization table" |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group assignment; for outcomes such as AQLQ, participant/caregiver is the outcome assessor; therefore these outcomes may be at risk of detection bias |
| Incomplete outcome data (attrition bias) | Low risk | 56 asthmatic patients enrolled and 50 completed the 2 study visits as per protocol. Balanced drop‐out |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. No power analysis reported. Outcomes listed in Methods all reported in the text |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 12 weeks Setting: paediatric respiratory outpatient clinics at NHS teaching hospitals in UK Trial registration: not reported | |
| Participants | Population: 80 children with asthma randomised to AeroChamber Plus with Flow‐Vu (FV) (n = 40) or AeroChamber Plus (AC) (n = 40) Age: children aged 1 to 5 years; mean age (SD) in the intervention group 2.8 (0.93) years, and in the control group 3.4 (1.09) years Baseline asthma severity: intervention group: "partly controlled ‐ or uncontrolled asthma"; baseline ACQ (SD): 1.75 (0.54); PAQLQ (total) (SD): 5.34 (0.90). Control group: "partly controlled ‐ or uncontrolled asthma"; baseline ACQ (SD): 1.91 (1.11); PAQLQ (total) (SD): 4.97 (1.05) Inclusion criteria: children aged 1 to 5 years with partially controlled or uncontrolled asthma according to GINA (2008) criteria and receiving parentally supervised inhalation therapy, including an inhaled corticosteroid, via a pMDI plus a spacer device Exclusion criteria: inhalation treatment had been changed over the 4 weeks before enrolment, using a dry powder inhaler or a breath‐activated pMDI, limited physical or mental ability to use a spacer or to follow study procedures, had other chronic disease conditions at study enrolment that might adversely affect their quality of life Percentage withdrawn: No participants withdrew from the trial Other allowed medication: "No change in the asthma medications was recorded for all participants throughout the study period" | |
| Interventions | Intervention summary: AeroChamber Plus with Flow‐Vu: designed with a visual feedback reassurance mechanism of an optimal inhalation; 4 visits over 12 weeks; visit 1 training given on correct use of AC. Randomisation occurred at visit 2, during which training on correct use of FV was given. 2 further follow‐up visits at 6 and 12 weeks post randomisation Control summary: currently available AeroChamber device, which does not have the visual feedback indicator; 4 visits over 12 weeks; visit 1 training given on correct use of AC. Randomisation occurred at visit 2, with further training on use of AC provided. 2 further follow‐up visits at 6 and 12 weeks post randomisation | |
| Outcomes | Outcomes measured: peak inspiratory flow (PIF), quality of life (PAQLQ), asthma control (ACQ), parent spacer preference on Likert scale Technique assessment method used: PIF was used as a measure of inhaler technique | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: Trudell Medical International, Canada: unconditional grant for the use of facilities at clinics used in the study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The children were randomised to use the AC or the FV according to a pre‐study designed randomisation table" |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment; outcomes such as PAQLQ and ACQ are subjective and may be at risk of performance bias |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group assignment; for outcomes such as PAQLQ and ACQ, participant/caregiver was the outcome assessor; therefore these outcomes may be at risk of detection bias |
| Incomplete outcome data (attrition bias) | Low risk | No drop‐out |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. However, all outcomes listed in Methods clearly reported in paper |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 6 to 8 weeks Setting: not reported Trial registration: not reported | |
| Participants | Population: 30 children with asthma randomised to Trainhaler (TH) group (n = 9) or verbal counselling (VC) group (n = 9). Children with adequate inhaler technique formed a "control" group (n = 12) (not of interest in this review, as not randomised; we have assigned the TH as the "intervention" arm and the VC as the "control" arm) Age: aged 7 to 17 years; mean age (SD) in the intervention group 9.9 (1.3) years, and in the control group 9.9 (3.3) years Baseline asthma severity: mean (SD) % predicted FEV1 in the intervention group 91.2 (14.6), and in the control group 84.1 (13.9) Inclusion criteria: asthmatic children, aged 7 to 17 years, with an MDI hand‐lung co‐ordination problem including IF > 60 L/min Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: not reported | |
| Interventions | Intervention summary: TH group trained on and given TH to practice at home Control summary: VC group received verbal MDI training with emphasis on using a slow and deep inspiratory flow rate | |
| Outcomes | Outcomes measured: inhaler technique, peak IF through the inhaler, asthma control (ACQ) Technique assessment method used: 11‐step MDI checklist | |
| Notes | Type of publication: conference abstract; does not appear to be a report of the same study as either of the full‐text reports identified for this study author Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised but no details (conference abstract). As with Ammari 2013 (although different interventions and only child participants), a control group with good technique was not included in the randomisation, and hence was not included in the review |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | Not possible to blind participants and personnel to interventions given |
| Blinding of outcome assessment (detection bias) | High risk | No mention of outcome assessor blinding and some outcomes were self‐rated (e.g. ACQ), so could have been biased by knowledge of group allocation |
| Incomplete outcome data (attrition bias) | Unclear risk | No mention of drop‐outs; conference abstract that does not appear to describe the same study as others reported by this study author |
| Selective reporting (reporting bias) | High risk | ACQ data can be extracted from the abstract and included in the review, but lack of a full publication for linking means we have very limited information about the study |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 3 months Setting: paediatric ward, Ireland Trial registration: not reported | |
| Participants | Population: 21 children with asthma randomised to DVD inhaler instruction or individual instruction (n for each group not reported) Age: not reported Baseline asthma severity: not reported Inclusion criteria: children already using or with newly prescribed inhalers over 3 months in paediatric ward Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: not reported | |
| Interventions | Intervention summary: DVD inhaler instruction about valved holding chamber use Control summary: individual instruction equivalent to information in the DVD; delivered by a physiotherapist | |
| Outcomes | Outcomes measured: inhaler technique, self‐efficacy and knowledge acquisition Technique assessment method used: "Technique was assessed immediately post and 3 months after education with a new outcome measure. Intra‐rater and inter‐rater reliability of the new measure was examined" | |
| Notes | Type of publication: conference abstract Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "21 participants were randomised to DVD or individual education" ‐ no further details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | "Technique was assessed pre‐education in non‐naive participants". Participants and personnel were aware of group allocation |
| Blinding of outcome assessment (detection bias) | High risk | No mention of blinded outcome assessment, but only a conference abstract available |
| Incomplete outcome data (attrition bias) | Unclear risk | Not reported |
| Selective reporting (reporting bias) | High risk | Numerical results not reported |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 2 weeks Setting: community pharmacies, Australia Trial registration: not reported | |
| Participants | Population: 26 people with asthma randomised to standard verbal counselling (group A) (n = 8), augmented verbal counselling (group B) (n = 9) or augmented verbal counselling as above, plus a physical demonstration (group C) (n = 9) Age: mean age 42 years; range 11 to 76 years Baseline asthma severity: across groups, at least 65% were using ICS; mild asthma = 15%, moderate asthma = 62%, severe asthma = 23% Inclusion criteria: had asthma, had been dispensed a Turbuhaler by the recruited pharmacist, aged 10 years or older Exclusion criteria: did not self‐administer Turbuhaler medication, did not speak or understand English, this was first Turbuhaler prescription Percentage withdrawn: 13% withdrew from group A, 11% from group B and 0% from group C Other allowed medication: not reported | |
| Interventions | Intervention summaries: Group A: instructions on Turbuhaler technique use following the text of 2 standard items of printed material supplied by the manufacturer. One‐off session with follow‐up at 2 weeks Group B: standard verbal counselling as described above plus extra verbal information, which included reinforcing the 4 essential steps. During both standard and augmented verbal counselling, the researcher was careful not to use hand gestures that might act as a surrogate physical demonstration. One‐off session with follow‐up at 2 weeks Group C: verbal counselling as above, plus a physical demonstration by the researcher, using a placebo Turbuhaler. Technique used in the physical demonstration was the same as illustrated in the product information, with the additional component that the Turbuhaler base was placed on a flat surface during loading. One‐off session with follow‐up at 2 weeks | |
| Outcomes | Outcomes measured: inhaler technique Technique assessment method used: 9‐step Turbuhaler checklist | |
| Notes | Type of publication: peer‐reviewed journal article and conference abstract Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "After assessment, patients were randomly allocated by computer‐generated list to receive one of 3 types of counselling" |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment, which may have changed their experience during the study |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group assignment; assessment of inhaler technique may be at risk of detection bias |
| Incomplete outcome data (attrition bias) | Low risk | Only 2 participants withdrew (1 from group A and 1 from group B) for reasons unrelated to the intervention |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified. The only outcome listed in the Methods is reported in paper, but some data are presented in only in graphs and cannot be used for meta‐analysis. In addition, baseline characteristics are given for the whole group ‐ not for each arm ‐ so we cannot assess for baseline imbalances, which may have affected response to the intervention |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: single‐blind parallel‐group cluster‐randomised controlled trial (i.e. each randomised pharmacist is a 'cluster') Duration: 26 weeks Setting: community pharmacies, Australia Trial registration: not reported | |
| Participants | Population: 31 pharmacists randomised; 97 patients with asthma subsequently enrolled. 16 pharmacists (53 patients) randomised to pharmacist–participant educational intervention and inhaler technique labels; 15 pharmacists (44 participants) randomised to peak flow measurement training (control) Age: mean participant age (SD) in the intervention group: Diskus 51.4 (8.3) years and Turbuhaler 45.48 (19.7) years. Mean participant age (SD) in the control group: Diskus 41.1 (20.0) years and Turbuhaler 38.85 (18.4) years Baseline asthma severity: intervention group: mean peak flow variability (Min%Max) (SD) Diskus 71.5 (9.7) and Tubuhaler 74.8 (9.2); control group: mean peak flow variability (Min%Max) (SD) Diskus 76.0 (7.2) and Tubuhaler 71.2 (8.7) Inclusion criteria: aged 14 years, doctor‐diagnosed asthma, use of inhaled corticosteroid by Turbuhaler or Diskus with or without long‐acting beta2‐agonist, no change in asthma medication or dose for 1 month Exclusion criteria: did not self‐administer medication, did not speak or understand English, were not able to return for all visits, were involved in another study Percentage withdrawn: 1 pharmacist withdrew from the intervention group, and 3 from the control group. 16% of participants withdrew across both groups Other allowed medication: not reported | |
| Interventions | Intervention summary: Both groups of pharmacists educated participants on measurement of peak expiratory flow (PEF) for assessment of peak flow variability. Active pharmacists also assessed participants' inhaler technique, without giving them feedback. At visit 2, active pharmacists again assessed participants' inhaler technique, then educated participants using a specialised "Show and Tell" Inhaler Technique counselling service, going through each step on the checklist to describe and demonstrate correct use, repeated up to 3 times if necessary, until the participant had correct technique on all steps. The pharmacist then used a highlighter pen to identify incorrect steps from that day’s initial assessment on an "Inhaler Technique Label", which was attached to the highlighted label on the participant's own controller medication inhaler. At each subsequent visit, active pharmacists repeated inhaler technique assessment/education and placed a new label on the participant's replacement inhaler (or on the old one if still in use). If no steps were incorrect on the initial assessment at any visit, the label was attached to the participant's inhaler with no highlighting. Five visits over 6 months Control summary: Both groups of pharmacists educated participants on measurement of peak expiratory flow (PEF) for assessment of peak flow variability. During the run‐in period, 1 researcher independently assessed inhaler technique for all control participants (to establish their baseline inhaler technique without providing information about correct inhaler technique to control pharmacists). No education was provided to participants during these assessments. For control participants, the researcher re‐assessed inhaler technique at the end of the study, then provided inhaler technique counselling | |
| Outcomes | Outcomes measured: peak flow variability, calculated as Min%Max (lowest morning PEF over 2 weeks, as percentage of highest PEF over the same period), Inhaler Technique Score, categorisation of asthma severity based on Australian Asthma Management Handbook, asthma‐related quality of life (AQOL), perceived control (PC) Technique assessment method used: 9‐step inhaler technique checklist | |
| Notes | Type of publication: 1 conference abstract, 1 peer‐reviewed journal article, 1 letter to the editor Funding: funded by the Faculty of Pharmacy, University of Sydney. HK Reddel was funded by the Asthma Foundation of NSW | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "After arrival, pharmacists were allocated randomly by computer‐generated list to Active or Control groups" |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | Participating pharmacists could not be blinded to group allocation. It is unclear whether participants were aware of their group allocation, although the trial is reported as 'single‐blind', and control participants did not have their inhaler technique assessed at 3 months "in order to avoid drawing their attention to inhaler technique" |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group assignment, although the study is reported as 'single‐blind'. Patient‐reported outcomes may have been affected by knowledge of group assignment. It is not clear whether the unblinded participating pharmacist, or a blinded researcher, assessed objective outcomes such as inhaler technique |
| Incomplete outcome data (attrition bias) | High risk | Although only 5 pharmacists dropped out, report states that 116 participants were enrolled, but only 97 returned from the second visit, at which the first intervention was delivered. It is not clear how many participants were initially enrolled into each arm. It is also unclear how many participants were assessed at 6 months for each outcome. Although it is stated that 97 'completed the study', the total n for those with correct technique at the end equals 84. It is not clear on what number the continuous outcomes were based |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. All outcomes listed in Methods appear to be reported in a peer‐reviewed publication and a letter to the editor |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 1 month Setting: primary care, UK Trial registration: not reported | |
| Participants | Population: 36 children with asthma randomised to an educational software intervention (n = 17) or placebo software (control) (n = 19) Age: children aged 7 to 11 years; mean age not given Baseline asthma severity: not reported Inclusion criteria: children aged 7 to 11 with asthma and with access to a personal computer Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: not reported | |
| Interventions | Intervention summary: an educational computer game called "Space Inhalers", containing educational material about inhaler technique and asthma information Control summary: the same "Space Inhalers" game as in the intervention arm, but without educational material | |
| Outcomes | Outcomes measured: inhaler technique, asthma knowledge Technique assessment method used: measured out of 15. No other details | |
| Notes | Type of publication: conference abstract Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "subjects were randomised", but no further details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | Low risk | Although it is not clear whether participants or their caregivers were aware of whether they were receiving the active or placebo intervention, it seems unlikely that children in the 7 to 11 year age range were likely to be substantially affected by performance bias as a result of this knowledge. The intervention took place at home, so knowledge of allocation by trial personnel was also unlikely to introduce bias |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group allocation; therefore assessment of inhaler technique and asthma knowledge may be at risk of detection bias |
| Incomplete outcome data (attrition bias) | Unclear risk | Drop‐out not reported |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified, and trial reported only as a conference abstract, so minimal details given. However, both planned outcomes ‐ asthma knowledge and inhaler technique ‐ are clearly reported |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 4 weeks Setting: recruited from rural junior high and high schools in southeastern Arkansas. Intervention delivered in health clinics in USA Trial registration: | |
| Participants | Population: 49 adolescents with asthma randomised to tele‐pharmacy counselling (n = 24) or written instructions only (n = 25) (control) Age: across both groups: 12 to 14 years = 43%, 15 to 17 years = 50%, 18 to 19 years = 7% Baseline asthma severity: not reported Inclusion criteria: diagnosis of asthma, previous MDI use, male or female adolescents in grades 7 to 12, access to a local health clinic with interactive compressed video equipment Exclusion criteria: not reported Percentage withdrawn: 38% of participants withdrew from the intervention group, and 12% from the control group Other allowed medication: not reported | |
| Interventions | Intervention summary: Participants in the tele‐pharmacy counselling group demonstrated MDI technique at baseline (pretest) during the first session. A pharmacist scored each performance using the MDI Technique Checklist. Participants received counselling that included verbal instructions and demonstrations by the pharmacist of any needed corrections to their MDI technique. Reassessment for MDI technique immediately followed counselling (post test). MDI technique was assessed a third time 2 to 4 weeks later (follow‐up). After the final assessment session, additional counselling by the pharmacist was provided for participants who needed corrections to their MDI technique or for those who had specific questions about asthma Control summary: The control group also demonstrated pretest, post‐test and follow‐up MDI technique. After completing the pretest assessment, this group received the "Patient’s Instructions for Use of the Metered‐Dose Inhaler" with written instructions for use of the MDI on a package insert provided with their placebo inhaler. These written instructions were reproduced from a patient inhaler package insert that included diagrams demonstrating proper MDI technique and instructions printed in small type. Counselling on correct MDI technique was not provided by the pharmacist during this assessment period. After reviewing the inhaler package insert, participants were immediately reassessed for MDI technique by the pharmacist. After completion of the final assessment, verbal instructions and demonstrations by the pharmacist were given to correct improper MDI technique. Participants in the control group were asked if they had any questions about asthma at this final session and were instructed accordingly | |
| Outcomes | Outcomes measured: MDI inhaler technique, patient satisfaction with intervention measured using a "Telepharmacy Metered‐Dose Inhaler Technique Evaluation instrument" (not previously validated) Technique assessment method used: MDI Technique Checklist (validated) evaluated 8 skills for proper MDI technique, including preparation of inhaler equipment, position of the mouth on the inhaler mouthpiece and breathing techniques. Maximum score = 8 | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: funded by a grant from the Office for the Advancement of Telehealth in the Department of Health Resources and Services Administration | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | '"The participants in the study were assigned to either a tele‐pharmacy counselling group or a control group using a random number chart" |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group allocation; therefore assessment of inhaler technique may be at risk of detection bias |
| Incomplete outcome data (attrition bias) | High risk | Unbalanced drop‐out (38% in the intervention group and 12% in the control group) may have introduced bias. In addition, no flow diagram was presented, and reasons for drop‐out were not given, apart from 8 participants who were excluded as they had never used an MDI ("Three students did not attend any visit, 8 students had never used an MDI in the past (and, therefore, did not meet the inclusion criteria), and 2 students did not attend the follow‐up visit for comparison") |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. However, all outcomes listed in Methods clearly reported in paper |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: open‐label parallel‐group randomised controlled trial Duration: 1 month Setting: 2 paediatric practices in a medium‐sized metropolitan county in North Carolina, USA Trial registration: NCT01641211 | |
| Participants | Population: 91 children and adolescents with asthma randomised to inhaler technique video (n = 46) or an attention control video (n = 45) Age: mean age (SD) in the intervention group was 10.9 (2.6) years, and in the control group 10.8 (2.9) years Baseline asthma severity: intervention group: mild persistent asthma = 52% moderate/severe asthma = 44%; control group: mild persistent asthma = 49% moderate/severe asthma = 51% Inclusion criteria: 7 to 17 years old, could speak English or Spanish, could read the assent form, were present at the visit with an adult (> 18 years old) caregiver (parent or legal guardian) who could speak English or Spanish, used an MDI, missed or incorrectly performed at least 1 step on an inhaler technique assessment, had mild, moderate or severe persistent asthma Exclusion criteria: not reported Percentage withdrawn: 7% of children withdrew from the intervention arm, and 13% from the control arm Other allowed medication: not reported | |
| Interventions | Intervention summary: 3‐minute video in English or Spanish. Separate videos were available for an MDI with or without a spacer; children who indicated that they had used an MDI with a spacer and without a spacer watched both MDI videos. Each inhaler video provided an overview of the device and specific instructions for how to use the device correctly. Children watched the videos on a laptop computer and were given a wallet card with a web address and login information, so they could watch the video again after leaving the clinic Control summary: control group: children allocated to an attention control group in which they watched a 3‐minute video about nutrition in English or Spanish. The nutrition video discussed the importance of balancing protein, carbohydrates and lipids in one’s diet | |
| Outcomes | Outcomes measured: inhaler technique, child inhaler self‐efficacy, asthma control (ACT) Technique assessment method used: MDI technique was measured as the number of steps (out of 8 possible steps) that the child performed correctly. The RA used an inhaler technique checklist to document whether each step was performed correctly | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: This pilot project was supported by Award Number ULTR000083 from the National Center for Advancing Translational Sciences. Dr Carpenter’s salary was supported in part by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant KL2TR000084 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The randomisation sequence was prepared ahead of time by a statistician who used computer‐generated random numbers. Randomisation was stratified by clinic |
| Allocation concealment (selection bias) | Low risk | Immediately after the child’s medical visit, the RA opened a sequentially numbered, sealed envelope to determine whether the child had been allocated to the experimental or control group |
| Blinding of participants and personnel (performance bias) | High risk | The study RA was not blinded to children’s experimental group assignment. All children and caregivers were informed that the study was about how children use their asthma devices |
| Blinding of outcome assessment (detection bias) | High risk | The study RA was not blinded to children’s experimental group assignment. All children and caregivers were informed that the study was about how children use their asthma devices |
| Incomplete outcome data (attrition bias) | Low risk | Less than 15% of participants were lost to follow‐up. All randomised participants were included in the adjusted intention‐to‐treat primary analysis |
| Selective reporting (reporting bias) | Low risk | The study was prospectively registered as NCT01641211; outcomes were reported as planned at all time points |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 1 week Setting: Italy; setting not reported Trial registration: not reported | |
| Participants | Population: 36 older adults with asthma randomised to MDI with Jet spacer (n = 18) or MDI without spacer (n = 18) Age: aged 65 years and older; mean age (SD) years in the intervention group 67.9 (1.6), and in the control group 67.6 (1.8) Baseline asthma severity: mean (SD) PEFR % predicted = 65.4(6) in the intervention group, and in the control group 65.5 (5) Inclusion criteria: aged 65 and older, imperfect inhaler technique at baseline, moderate asthma (PEFR 60% to 80% predicted), reversibility (15%+ increase in FEV1 30 minutes post 200 mcg salbutamol), ability to co‐operate and to be instructed on use of inhalers Exclusion criteria: airway infection, serious comorbidity, inability to abstain from theophylline or LABA use during study Percentage withdrawn: 0% of participants withdrew from the intervention group, and 6% from the control group Other allowed medication: inhaled steroids, inhaled sodium cromoglycate and nedocromil were allowed if patients were already receiving these drugs. LABA, oral bronchodilators and anticholinergics were not allowed | |
| Interventions | Intervention summary: small (approx. 10 cm diameter) spacer device used with MDI. Intended to reduce need for co‐ordination of actuation and inhalation, to reduce oropharyngeal deposition and to increase deposition in lower airways Control summary: standard MDI without spacer device | |
| Outcomes | Outcomes measured: FEV1, PEFR, patient‐reported acceptability of device, adverse events Technique assessment method used: technique not measured or reported | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as 'randomised' but no other details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | Low risk | Although no description of procedures intended to blind participants or personnel to group assignment, outcomes measured in this study unlikely to be prone to detection bias and not included in meta‐analysis |
| Incomplete outcome data (attrition bias) | Low risk | Only 1 participant withdrew from the study; reason for withdrawal given |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. However, all outcomes listed in Methods clearly reported in paper |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 12 weeks Setting: "hospital" based, country not stated Trial registration: not reported | |
| Participants | Population: 89 people with asthma randomised to an education intervention group (n = 43) or a control group (n = 46) (n not stated explicitly for each group; these numbers are calculated from the percentage female given per group) Age: mean age (SD) in the intervention group 41 (14) years, and in the control group 41 (12) years Baseline asthma severity: "uncontrolled" asthma Inclusion criteria: non‐smoking patients with new, uncontrolled asthma reporting to hospital Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: not reported | |
| Interventions | Intervention summary: inhaler technique education delivered by respiratory therapist (no further details) Control summary: routine inhaler technique instruction delivered by physician (no further details) | |
| Outcomes | Outcomes measured: inhaler technique and asthma control (ACT) Technique assessment method used: not described | |
| Notes | Type of publication: conference abstract Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as 'randomised', but no details of sequence generation |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | Unclear risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment; for patient‐reported outcomes, such as ACT, the participant was the outcome assessor |
| Incomplete outcome data (attrition bias) | Unclear risk | Drop‐out not reported |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified. Minimal details, as reported as conference abstract only. Unclear what "asthma control" percentage refers to. Number of participants included in analysis unclear |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: single‐blind parallel‐group randomised controlled trial Duration: intervention and assessment on the same day Setting: GP surgeries in Camden followed by 'snowball' convenience sampling method was therefore used; contacts in social clubs and informal networks in Tower Hamlets and Camden, UK Trial registration: not reported | |
| Participants | Population: 69 Turkish‐speaking people with asthma randomised to a multi‐media touch screen system (MTS) (n = 34) or translated patient information leaflet (PIL) plus support from a translator (PIL + verbal) (n = 35) (PIL + supported treatment as control) Age: mean (SD) age across both groups 41 (17.5) years Baseline asthma severity: not reported Inclusion criteria: Turkish‐speaking people with asthma who use an MDI Exclusion criteria: not reported Percentage withdrawn: not drop‐out Other allowed medication: not reported | |
| Interventions | Intervention summary: MTS system covered key steps in correct inhaler use and additional information on posture. Participant could interact with the programme by selecting to replay a step, or could move on to the next one. Participants were allowed to use the programme for as long as they wished before repeating the demonstration. The researcher/translator identified areas where technique could be improved, then spent up to 15 minutes discussing this with the user Control summary: Leaflet was produced by one of the trial authors (fluent in Turkish) and was an exact translation of the current version of Allen and Hanbury’s PIL for the Ventolin MDI. Participants were allowed to study the leaflet for as long as they wished before repeating the demonstration. The researcher/translator identified areas where technique could be improved, then spent up to 15 minutes discussing this with the user | |
| Outcomes | Outcomes measured: inhaler technique Technique assessment method used: Participants were videotaped while using their inhaler before and after the intervention. Blinded assessor rated their technique first as a 'quick check', then using a checklist | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: funded by the Department of Health and the North London Primary Care Research Network (Nocten) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | '"Patient allocation was done using random number tables" |
| Allocation concealment (selection bias) | Unclear risk | '"Patients did not know in advance which information method they would receive" but no description of concealing allocation from investigators |
| Blinding of participants and personnel (performance bias) | High risk | Participants and personnel were aware of group allocation |
| Blinding of outcome assessment (detection bias) | Low risk | "These assessors (of the inhaler technique videos) did not attend experimental sessions and had no contact with patient volunteers. They were therefore blind as to the information format" |
| Incomplete outcome data (attrition bias) | Low risk | Study was completed in 1 session, with technique assessed before and after instruction. No drop‐out |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. Only outcome described in Methods (inhaler technique) is clearly reported, but baseline characteristics per arm not given, so not able to objectively assess for baseline imbalance |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 15 days Setting: France; setting not reported Trial registration: not reported | |
| Participants | Population: 45 people with asthma randomised to patient information sheet (group 1) (n = 14) or video group (group 2) (n = 14) or video + spacer (group 3) (n = 17) Age: 10 to 71 years; mean (SD) age in group 1: 48 (17) years, in group 2: 35 (19) years and in group 3: 26 (20) years Baseline asthma severity: mean (SD) baseline FEV1 (L): group 1: 2.03 (0.65), group 2: 1.89 (0.61), group 3: 1.77 (0.66) Inclusion criteria: asthma characterised by attacks of paroxysmal dyspnoea with wheezing and a reversible airway obstruction demonstrated in the year preceding inclusion; using daily MDI, but with imperfect technique; had to speak and understand French, be cooperative with the study procedure and not be using a spacer device. Treatment of patients must be stable for 15 days before the start of the study and during the 15 days of the study Exclusion criteria: not reported Percentage withdrawn: no drop‐out Other allowed medication: not reported, although 22 patients were using ICS, and 22 theophylline | |
| Interventions | Intervention summaries: Group 1: Participants received MDI use education by reading an information sheet, which included a statement by the doctor and diagrams, for 3 to 4 minutes Group 2: Participants viewed a 5‐minute video describing correct use of the MDI Group 3: Participants viewed the same film as the video group but extended by 2 minutes to describe the use of a spacer device. Participants were also given a spacer device. This group was intended to act as a positive control with optimal inhalation technique | |
| Outcomes | Outcomes measured: FEV1, inhalation technique score Technique assessment method used: 4‐item checklist | |
| Notes | Type of publication: single peer‐reviewed journal article (in French) Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were allocated to 1 of 3 groups according to a randomisation code, revealed, for each participant, just before the education |
| Allocation concealment (selection bias) | Low risk | "Revealed, for each patient, just before the education" suggests that this was kept concealed in advance |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group allocation; therefore assessment of inhaler technique may be at risk of detection bias |
| Incomplete outcome data (attrition bias) | Low risk | Appears all participants completed follow‐up |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified. All outcomes listed in Methods appear to be reported, but some in graphs, so unable to extract. Inhaler technique data for positive control group also not given, but likely because use of the spacer device made this group incomparable with the other 2 groups |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 26 weeks Setting: 66 community pharmacies, Belgium Trial registration: not reported | |
| Participants | Population: 201 adults with asthma randomised to a pharmacist education intervention (n = 107) or to usual pharmacy care (n = 94) Age: mean age (range) in the intervention group 35.2 (19 to 51) years, and in the control group 36.3 (17 to 51) years Baseline asthma severity: in the intervention group, 5.6% had an ACT score < 15 (indicating poor control), and in the control group 8.5% had a score < 15 Inclusion criteria: required to carry a prescription for asthma medication. In consecutive order, patients visiting the pharmacy were invited to participate in the study when they fulfilled the following inclusion criteria: aged between 18 and 50 years; being treated for asthma for > 12 months; 3) ‘‘using’’ controller medication; and 4) regular visitor to the pharmacy Exclusion criteria: smoking history of .10 pack‐years, suffering from another severe disease (e.g. cancer) and with an ACT score at screening of,15 (indicating seriously uncontrolled asthma; for ethical reasons, patients were immediately referred to their general practitioner (GP) or respiratory specialist) or equalling 25 (indicating complete asthma control; no room for improvement) Percentage withdrawn: 25% of participants withdrew from the intervention group, and 26% from the control group Other allowed medication: not reported | |
| Interventions | Intervention summary: Before the start of the present study, participating pharmacists had a training session about asthma (pathophysiology), its non‐pharmacological and pharmacological treatment (GINA guidelines) and use of the study protocol. Participants in the intervention group received a protocol‐defined intervention at the start of the study and at 1‐ and 3‐month follow‐up visits Control summary: Participants in the control group received usual pharmacist care | |
| Outcomes | Outcomes measured: asthma control (ACT), patient diary (nocturnal awakenings due to the number of inhalations of rescue medication; the best of 3 measurements of peak expiratory flow), severe asthma exacerbations (defined as those requiring treatment with oral glucocorticoids (individually recorded in computerised pharmacy records) or an emergency department visit or hospital admission due to asthma), adherence to medication (prescription refill rates and self‐reporting), AQLQ, asthma knowledge inhaler technique Technique assessment method used: 10‐point checklist for MDI + spacer and 8‐point checklist for DPI (1 point for each correct step, but total score of 0 given in major error made, e.g. failure to remove cap) | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: funding not reported but study authors thank GlaxoSmithKline (GSK) Belgium for permission to use the Asthma Control Test | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The sequence of allocation to either control or intervention group was predetermined by the investigators based on a randomisation table" |
| Allocation concealment (selection bias) | Low risk | "Serially numbered, closed envelopes were made for each participating pharmacy. The envelope with the lowest number was opened by the pharmacist upon inclusion of a new patient" |
| Blinding of participants and personnel (performance bias) | High risk | It was not possible to blind participants, so some outcomes such as ACT and AQLQ are subject to potential performance bias, as participants knew to which group they were assigned |
| Blinding of outcome assessment (detection bias) | High risk | Blinding of outcome assessors is not described, and it appears that inhalation technique was assessed by the pharmacist delivering the intervention. Other patient‐reported outcomes (such as ACT and AQLQ) are also at risk because the participant was the outcome assessor |
| Incomplete outcome data (attrition bias) | High risk | Approximately 25% of participants dropped out of each arm of the trial. Although reasons were similar and baseline characteristics of those completing and not completing did not differ significantly, rate of drop‐out still high; we cannot be sure this did not affect the results. Secondary outcomes were analysed per protocol rather than by ITT |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified, although all outcomes listed in Methods reported in text/tables |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 2 months Setting: "outpatients", Iran Trial registration: not reported | |
| Participants | Population: 46 people with asthma randomised to inhaler technique education (n = 25) or no education/usual care (n = 20) Age: mean age (SD) across both group 48 (13) years Baseline asthma severity: "According to ACT score, none of patients were in complete asthma control at the beginning" Inclusion criteria: not reported Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: not reported | |
| Interventions | Intervention summary: face‐to‐face education about proper use of inhalers (no further details) Control summary: usual care (no further details) | |
| Outcomes | Outcomes measured: asthma control (ACT) and FEV1 Technique assessment method used: inhaler technique not reported | |
| Notes | Type of publication: conference abstract Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly placed"; no further details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group assignment; for patient‐reported outcomes, such as ACT, participant was the outcome assessor |
| Incomplete outcome data (attrition bias) | Low risk | No description of drop‐outs but numbers reported and related percentages suggest that only 1 person did not complete the study |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. Minimal details, as reported as conference abstract only. Unclear how "complete control" is defined. Unclear how many participants were included in the analyses at each time point |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: single‐blind parallel‐group randomised controlled trial Duration: 12 weeks Setting: allergy outpatient clinic in the urban area of Istanbul, Turkey Trial registration: not reported | |
| Participants | Population: 130 children with asthma randomised to face‐to‐face nurse training (n = 66 completed) or no training (package insert) (n = 54 completed). NB: n randomised to each arm not reported Age: mean (SD) age in intervention group 8.2 (1.7) years, and in control group 7.7 (0.9) years Baseline asthma severity: in the intervention group 51 classified as mild asthma, 15 as moderate; in the control group 42 classified as mild asthma; 12 as moderate Inclusion criteria: mild to moderate asthma and attending outpatient allergy clinic. Diagnosis and severity of asthma defined according to GINA 2005 Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: Participants were permitted to take salbutamol or terbutaline as needed for relief of symptoms."None of the patients had previously received an MDI with spacer, and none had taken oral steroids in the past 1‐month" | |
| Interventions | Intervention summary: At the beginning of the study, the active group was educated at home on correct use of the MDI spacer by 2 paediatric nurse specialists certified in allergy‐pulmonology. All of the children in this study group received instruction. All participants were prescribed fluticasone propionate 125 mg 1 puff by an MDI with a small‐volume Aerochamber spacer twice daily for 12 weeks. Educational pamphlets, such as those on asthma management, prophylactic measures and trigger avoidance, were also distributed to both groups Control summary: The control group was left as a baseline, meaning that group members did not receive any formal education on correct use of the MDI spacer. However, all study participants received the Aerochamber package insert, which includes information on how to use the device. All participants were prescribed fluticasone propionate 125 mg 1 puff by an MDI with a small‐volume Aerochamber spacer twice daily for 12 weeks. Educational pamphlets, such as those on asthma management, prophylactic measures and trigger avoidance, were also distributed to both groups | |
| Outcomes | Outcomes measured: inhalation skill, health‐related quality of life (PAQLQ), spirometry. All participants were asked to keep an asthma diary on the presence of asthma symptoms and on the use of main and additional antiasthmatic drugs Technique assessment method used: Inhalation skill scoring was done using the standardised MDI spacer checklist. Summation of 10 item scores not weighted equally | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Our subjects were randomly classified into study and control groups at the beginning of therapy" ‐ no further details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | "At the end of the 12 weeks, a paediatric allergist blinded to the results of the pulmonary function parameters (PFPs), rated each child’s MDI spacer skills after asking the child to demonstrate how he or she used the MDI spacer at home". However, it is not clear if this outcome assessor was blinded to group allocation, and for patient‐reported outcomes, such as AQLQ, the un‐blinded participant was the outcome assessor |
| Incomplete outcome data (attrition bias) | Unclear risk | Drop‐out not clearly reported (130 children were randomised and 120 are included in the analyses because 10 dropped out. eAlthough this represents fairly low drop‐out overall of 7.7%, it is not clear to which groups the drop‐outs were randomised) |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified, and the PAQLQ is reported only as a correlation with the MDI checklist, not as means per group |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: open‐label parallel‐group randomised controlled trial Duration: 4 weeks Setting: "clinics", Iran Trial registration: IRCT2013091514666N1 | |
| Participants | Population: 90 adults with asthma randomised to face‐to‐face training: non‐spacer group (n = 30) or face‐to‐face training: spacer group (n = 30) or no training (control) (n = 30) Age: mean age (SD) in the non‐spacer group was 41.5 (9.1), in the spacer group 42.7 (13.8) and in the control group 44.7 (10.8) Baseline asthma severity: not reported; however, mean duration of asthma ranged from 2.6 to 2.8 years across groups (with SD < 1.0), which is surprisingly short given the age of participants Inclusion criteria: asthmatic patients who had been referred to the clinics affiliated with Shiraz University of Medical Science, Shiraz. 18 to 60 years old, with a past history of using salbutamol MDI for at least 3 months, and not participating in similar interventional programmes Exclusion criteria: smoking, having an asthmatic attack and not willing to continue co‐operation in the study Percentage withdrawn: no withdrawals Other allowed medication: salbutamol | |
| Interventions | Non‐spacer group: Three educational sessions, both theoretical and practical, were held for the 2 intervention groups. Inhalation techniques with and without spacer were taught in the spacer group and the non‐spacer group, respectively. Educational classes included presenting a lecture, showing a PowerPoint, holding a question and answer session and evaluating participants at the end of the session. The content of instructional sessions in the non‐spacer group included the principles of asthma, the importance and advantages of correct inhalation technique, training on inhalation technique without using a spacer and repetition and reinforcement of training presented in 3 sessions Spacer group: as for non‐spacer group but amended to teach correct use of MDI with a spacer Control group: Control group did not receive any interventions | |
| Outcomes | Outcomes measured: PEFR and inhalation skills Technique assessment method used: two 11‐item checklists for checking MDI usage skills scored by 0 and 1 (double‐rated in advance on 10 participants showing correlation of 0.95). A separate checklist was used for MDI with and without spacer, and the control group was assessed on both | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The subjects were randomly divided into two intervention groups and a control group using block randomization with a random sequence of 6 block sizes." |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | "It should be noted that the patients were aware of the reasons of the interventions and the research was not thus blinded" |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind outcome assessors to group allocation; therefore assessment of inhaler technique may be at risk of detection bias |
| Incomplete outcome data (attrition bias) | Low risk | No drop‐out, no exclusions from the analysis |
| Selective reporting (reporting bias) | Unclear risk | Prospectively registered trial (IRCT2013091514666N1); all listed outcomes reported |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: single‐blind parallel‐group randomised controlled trial Duration: 8 to 20 weeks Setting: 1 inner city asthma clinic, part of Cook County Hospital, Illinois Trial registration: not reported | |
| Participants | Population: 68 people with asthma randomised to face‐to‐face verbal training + demonstration (n = 36) or written training (package insert) (n = 32) Age: mean (SD) age in the intervention group 49.5 (16.5) years, and in the control group 43.6 (13.5) years Baseline asthma severity: baseline FEV1 (SD) (L) in the intervention group 2.18 (0.95), and in the control group 2.05 (0.75) Inclusion criteria: diagnosed, stable asthmatic patients who had been in the Pulmonary/Asthma clinic for 6 months Exclusion criteria: missed more than 25% of appointments in the previous 6 months, had an ED visit in the month before entry or 2 or more visits in the prior 6 months, taking more than 10 mg of oral prednisolone daily or 30 mg every other day, unable to read or understand English Percentage withdrawn: 11% of participants withdrew from the intervention arm, and 13% from the control arm Other allowed medication: All participants had access to albuterol in an MDI and pirbuterol in BAI | |
| Interventions | Intervention summary: Experimental group received verbal instructions and demonstration on breath actuated inhaler technique. Participants were asked to demonstrate their inhalation technique to the instructor, who counselled them until their technique was deemed proper. Also were given written instructions (package insert). Both experimental and control group participants demonstrated their MDI technique to the instructor upon enrolment (baseline MDI). The instructor then gave them a demonstration of MDI technique and counselled them on correct use of the MDI Control summary: Control group received written instruction only on breath actuated inhaler use. After receiving instructions, participants also demonstrated their technique to the instructor, who did not correct them or give feedback if incorrect. Both experimental and control group participants demonstrated their MDI technique to the instructor upon enrolment (baseline MDI). The instructor then gave them a demonstration of MDI technique and counselled them on correct use of the MDI | |
| Outcomes | Outcomes measured: BAI and MDI competency Technique assessment method used: Scoring was based on competency features repeated in scientific literature. Participants had to complete all steps successfully for each of the respective inhalers to be given a score of 1. If any steps were missed, participants were given an overall score of zero for that inhaler technique | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: funded in part by a grant from 3M Pharmaceuticals, St. Paul, Minnesota, USA | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomized either to an experimental group or control group in order to evaluate two different teaching methods" ‐ no further details (although randomisation reported to be 'successful' owing to lack of baseline imbalance) |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | Low risk | "Patients demonstrated their BAI and MDI techniques to an independent physician who was blinded as to their group assignment" |
| Incomplete outcome data (attrition bias) | Low risk | 68 participants were randomised (36 and 32 in experimental and control groups) and 60 were included in the analyses (32 and 28). Hence, 4 participants dropped out of each group, which was 11.1% and 12.5% drop‐out in intervention and control groups. These people were not included in the analysis, but drop‐out was low and balanced |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified, although all outcomes listed in Methods reported |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: single‐blind parallel‐group randomised controlled trial Duration: intervention and assessment on the same day Setting: 4 GP surgeries in North London, UK Trial registration: not reported | |
| Participants | Population: 110 adults and adolescents with asthma randomised to a multi‐media touch screen system (MTS) (n = 57) or written training (package insert) (n = 48) Age: aged 12 to 87 years, mean (SD) not given Baseline asthma severity: 44% of participants in the intervention group BTS step 3 and above; 38% in the control group Inclusion criteria: Patients over 12 years old, recorded as using a bronchodilator MDI in the past 6 months, were identified from surgery repeat medication records by the practice manager. Exclusion criteria: problem patients, those known not to speak English well Percentage withdrawn: 9% of participants dropped out from the intervention arm, and 10% from the control arm Other allowed medication: not reported | |
| Interventions | Intervention summary: The demonstration on the multi‐media touch screen computer (MTS) covered key information points contained in pictures 1 to 6 of the ‘How to use your inhaler’ section of the Ventolin patient information leaflet. Key messages given in the voice‐over were reinforced as on‐screen text. After each step, the participant could choose whether to proceed, or to replay a section. At the end, the participant could choose to repeat a section, or the whole demonstration. This could be done as many times as the participant wished. Participants were asked to demonstrate how they used their inhaler, and this was videotaped before and after the participant received information. Remaining technique errors were discussed and documented, and participants were referred on to the practice nurse or GP if required Control summary: The patient information leaflet used was a laminated copy of the 1996 version of the Ventolin pack leaflet. Both MTS and PIL used white male models as demonstrators. Participants were asked to demonstrate how they used their inhaler, and this was videotaped before and after the participant received information. Remaining technique errors were discussed and documented, and participants were referred on to the practice nurse or GP if required | |
| Outcomes | Outcomes measured: global inhaler technique, co‐ordination of inspiration and inhaler actuation, breathing in time, information acceptability and usefulness (agree, neutral, disagree to a series of 18 statements about information format and content) Technique assessment method used: Videotaped demonstrations were assessed ‘blind’ by an assessor who did not attend experimental sessions and had no contact with participant volunteers. Global technique was rated as poor, adequate or good, and individual steps were scored as correct/incorrect with the use of a checklist. Inhaler shaking (counts) and length of inspiration (seconds) were assessed directly from videotaped recordings | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: funded by the Department of Health and the North London Primary Care Research Network | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patient allocation was done using random number tables, and was stratified by age" |
| Allocation concealment (selection bias) | Unclear risk | "Patients did not know in advance which information method they would receive", but no description of concealing allocation from investigators |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | Low risk | "They (videos of participants using the inhaler) were subsequently assessed ‘blind’ by an assessor who did not attend experimental sessions and had no contact with patient volunteers" |
| Incomplete outcome data (attrition bias) | Low risk | Less than or equal to 10% drop‐out in both groups |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. Only outcome described in Methods (inhaler technique) is clearly reported |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 52 weeks Setting: research clinic at Princess Margaret Hospital for Children, Perth, Australia Trial registration: not reported | |
| Participants | Population: 132 children with asthma randomised to the Funhaler incentive device (n = 64) or Aerochamber control (n = 68) Age: median (range) age in the intervention group 4.25 (2 to 7) years, and in the control group 4.25 (2.1 to 6.9) years Baseline asthma severity: 100% were receiving ICS at baseline (reduced to 67% in intervention group and 70% in control group by end of study) Inclusion criteria: asthma diagnosed by a doctor, prescribed inhaled steroids for treatment of their asthma Exclusion criteria: known immunodeficiency, chronic lung disease other than asthma, known allergy to study medication, had been administered systemic steroids in the 2 months before the baseline study visit Percentage withdrawn: 27% of participants withdrew from the intervention arm, and 6% from the control arm Other allowed medication: none mentioned as excluded. Participants were allowed to continue to take salmeterol | |
| Interventions | Intervention summary: 1‐month run‐in: Children were switched to fluticasone if on a different ICS. Those using a spacer with face mask were instructed to use the mouthpiece instead. Spacer technique was checked and corrected if necessary. Children then received regular inhaled fluticasone through a Funhaler Control summary: 1‐month run‐in: Children were switched to fluticasone if on a different ICS. Those using a sacer with face mask were instructed to use the mouthpiece instead. Spacer technique was checked and corrected if necessary. Children then received regular inhaled fluticasone through a conventional valved spacer (Aerochamber) | |
| Outcomes | Outcomes measured: asthma control defined as daytime asthma symptoms less than twice a week and night‐time awakenings less than once a month. For 1 week before every study visit, parents documented symptoms of cough and wheeze and bronchodilator use on diary cards. Quality of life (QOL) was measured with the PedsQL 3.0 Asthma Module questionnaire, based on parental response at each study visit Technique assessment method used: Proficiency in spacer technique was measured at the first 4 visits by measuring the amount of salbutamol inhaled from spacer onto a filter interposed between participant and spacer. Five separate doses of salbutamol were administered to ensure that a measurable amount of drug was deposited onto the filters | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: funded in part by a grant from the NIH: R01 HL70967. The fluticasone used in the study was supplied by GlaxoSmithKline, Australia. The Funhaler devices used in the study were sponsored by Visiomed, Australia. Sponsors did not have access to the data and played no part in analyses or in interpretation of the data NB: As data were not normally distributed, samples were compared using the Mann–Whitney U‐test | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "After the 1‐month run‐in period, at the baseline study visit, subjects were randomised, using the block randomisation method" |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | ''No description of procedures intended to blind participants or personnel to group assignment and for patient reported outcomes, such as PedsQL, the participant/career is the outcome assessor" |
| Incomplete outcome data (attrition bias) | High risk | "Significantly more subjects dropped out of the Funhaler group (17 vs 4; P < 0.01)", which may have impacted the results. In addition, it is not always clear how many participants were included in the analysis at each time point for quality of life |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified; although all outcomes listed in Methods are reported, it is not always clear how many participants were included in the analysis |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 1 to 16 weeks (mean 6) but no training (control group); not followed up after initial assessment Setting: allergy clinic in Memphis, Tennessee, USA Trial registration: not reported | |
| Participants | Population: 29 adults with asthma randomised to face‐to‐face pharmacist training (n = 9) or video training (n = 10) or no training (package insert) (n = 10) Age: mean age 39 years across all 3 groups Baseline asthma severity: 4 participants in each group had previously used the devices ‐ most were not taking/did not need MDIs Inclusion criteria: mildly asthmatic adults ‐ "mildly asthmatic" Exclusion criteria: not reported Percentage withdrawn: no drop‐out Other allowed medication: not reported | |
| Interventions | Face‐to‐face training: personal instruction by 1 of 2 pharmacists on use of the inhaler while in the physician's office Video training: Participants watched a videotaped programme of instruction produced by investigators No training: received only an information sheet reflecting the manufacturer's direction and the current literature | |
| Outcomes | Outcomes measured: inhaler technique/effectiveness of instruction Technique assessment method used: 10‐point checklist with equal weight items assessed by the physician | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "We randomly assigned 29 mildly asthmatic adults" ‐ no further details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | Unclear risk | Inhaler technique was assessed by a "specially trained technician". This was not the person who delivered the intervention, but it is not clear if this person knew to which group each participant belonged |
| Incomplete outcome data (attrition bias) | Low risk | No drop‐out |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. Only outcome described in Methods (inhaler technique) is clearly reported, although control group is not followed up |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: open‐label randomised trial; design not clearly reported Duration: not reported Setting: 1 hospital, Evanston, Illinois, USA Trial registration: not reported | |
| Participants | Population: 50 people with asthma randomised to computer training, written training or no training (n in each group not reported) Age: not reported Baseline asthma severity: not reported Inclusion criteria: not reported Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: not reported | |
| Interventions | Computer training: Participants completed a "computer based training solution" such as those at www.use‐inhalers.com Written training: "traditional written instruction on inhaler technique" No training: "our controls were patients without any training and patients given written training" | |
| Outcomes | Outcomes measured: inhaler technique Technique assessment method used: "videotapes of patients using their inhalers before and after training were created and analysed by a fixed rubric and given a score" | |
| Notes | Type of publication: conference abstract Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "patients were recruited in a randomized, unblinded enrolment process." ‐ no further details |
| Allocation concealment (selection bias) | High risk | "randomized, unblinded enrolment process" ‐ implies that allocation was not concealed |
| Blinding of participants and personnel (performance bias) | High risk | Described as 'unblinded' |
| Blinding of outcome assessment (detection bias) | Unclear risk | Described as 'unblinded', although 'Inhaler technique was assessed by "fixed rubric", which may have controlled for some bias, depending on who was making the assessment and whether they knew what sort of training the participant had received |
| Incomplete outcome data (attrition bias) | Unclear risk | Drop‐out not reported |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified. Minimal details reported as conference abstract only |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 4 weeks Setting: Tripoli, Libya. Setting not reported Trial registration: not reported | |
| Participants | Population: 76 people with asthma randomised to face‐to‐face verbal training + 2Tone training aid (n = 26) or face‐to‐face verbal training alone (n = 25) (those with correct MDI technique were used as a control group; others were randomised to 2 training groups relevant to this review) Age: not reported Baseline asthma severity: not reported Inclusion criteria: patients with asthma using MDI Exclusion criteria: not reported Percentage withdrawn: not reported Other allowed medication: not reported | |
| Interventions | Intervention summary: face‐to‐face verbal training + 2Tone training aid (no further details) Control summary: face‐to‐face verbal training alone (no further details) | |
| Outcomes | Outcomes measured: inhalation flow rate, FEV1, Jones Morbidity Index (JMI) and Juniper AQLQ Technique assessment method used: inhalation flow rate through MDI | |
| Notes | Type of publication: conference abstract Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as 'randomised' but no details of sequence generation |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment; for patient‐reported outcomes, such as QOL, the participant was the outcome assessor |
| Incomplete outcome data (attrition bias) | Unclear risk | Drop ‐out not reported |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified. Minimal details reported as conference abstract only |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐cluster repeated‐measures randomised controlled trial; blinding not stated Duration: 4 weeks Setting: 1 community pharmacy, Australia Trial registration: not reported | |
| Participants | Population: 19 pharmacists (101 adult patients) randomised to pharmacist training + quantitative inhaler feedback (51 patient participants) or to pharmacist training no quantitative feedback (50 patient participants) (control) Age: mean age not reported; age categories given (18 to > 60 years) Baseline asthma severity: mean (SD) ACQ score in intervention group: 1.6 (0.96), and in control group 1.7 (1.01) Inclusion criteria: diagnosis of asthma and aged 18 years or over; currently using a Turbuhaler (TH) or Accuhaler (ACC) for delivery of preventer asthma medication; having been on the same asthma medication and dose regimen for a minimum of 1 month Exclusion criteria: medication not self‐administered; inability to speak or understand English; inability to return for follow‐up visit; and/or involved in another clinical trial/study Percentage withdrawn: 6% of patient participants withdrew from the intervention group, and 2% from the control group Other allowed medication: not reported | |
| Interventions | Intervention summary: combination of qualitative and quantitative visual feedback for DPI inhalers. Training of community pharmacists occurred on an individual basis with the researcher delivering a 2‐hour 1‐on‐1 training session to each pharmacist in their own community pharmacy. Intervention group pharmacists were also trained as per a train‐the‐trainer approach and an established pharmacist‐training programme with an additional quantitative feedback process. Quantitative feedback involved the use of a portable hand‐held spirometer, which has been developed with the ability to assess breathing manoeuvres associated with the use of different inhaler devices. It is a preprogrammed device that can measure breathing manoeuvres and provides feedback in both numerical and visual/graphic forms. Actual breathing manoeuvres are then compared with optimal manoeuvres for a particular inhaler. This allows patients to see exactly where they are making errors and to what extent. A DVD showing HCPs delivering inhaler technique education to people with asthma was used to consolidate the training of pharmacists. Pharmacists also received an update on basic asthma management and inhaled medications Control summary: current best practice DPI inhaler technique education utilising qualitative visual feedback. Training of community pharmacists occurred on an individual basis, with the researcher delivering a 2‐hour 1‐on‐1 training session to each pharmacist in their own community pharmacy. Control group pharmacists were trained as per a train‐the‐trainer approach and an established pharmacist‐training programme. A DVD showing HCPs delivering inhaler technique education to people with asthma was used to consolidate the training of pharmacists. Pharmacists also received an update on basic asthma management and inhaled medications | |
| Outcomes | Outcomes measured: asthma control (ACQ), inhaler technique Technique assessment method used: The inhaler technique was assessed according to manufacturer‐approved checklists. Individuals were considered to use the correct technique if they were able to perform all steps in the checklist correctly. Inhaler technique data were represented in 2 ways: proportion of participants with correct technique and mean number of steps performed correctly for each device | |
| Notes | Type of publication: peer‐reviewed journal article Funding: This study was funded by the Australian Postgraduate Award. The DVD was funded through Australian Research Council Linkage Project LP LP0882737. Checklists were developed in collaboration with the National Prescribing Service, Sydney, Australia, through funding from the Australian Research Council Linkage Project LP LP0882737 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "19 community pharmacists were recruited and randomised" ‐ no further details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | High risk | 'No description of procedures intended to blind outcome assessors to group allocation; therefore assessment of inhaler technique and asthma control may be at risk of detection bias |
| Incomplete outcome data (attrition bias) | Low risk | Less than 10% drop‐out in both groups |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified; all outcomes listed in methods reported |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: single‐blind parallel‐group randomised controlled trial Duration: 26 weeks Setting: 1 asthma clinic in a paediatric hospital, Canada Trial registration: not reported | |
| Participants | Population: 96 children and adolescents with asthma randomised to nurse training: interactive with feedback (n = 47) or nurse training: pictorial only (n = 49) Age: median (range) age in the intervention group was 4.5 (0.75 to 15) years, and in the control group 5.75 (0.75 to 15) years Baseline asthma severity: in the intervention group: 57% mild; 32% moderate; 11% severe asthma; in the control group: 55% mild; 35% moderate; 10% severe asthma Inclusion criteria: children between 1 and 18 years of age starting aerosol therapy for the first time Exclusion criteria: younger than 1 year or older than 18 years, previous teaching session of technique of aerosol administration, language other than French or English, if another member of the family suffered from asthma and was using inhalers Percentage withdrawn: 43% of participants withdrew from both intervention and control arms Other allowed medication: not reported | |
| Interventions | Intervention summary: Experimental participants received an interactive teaching session from the asthma clinic nurse that lasted about 15 minutes. Instruction was given with picture diagrams provided with inhalation devices by pharmaceutical companies. This was followed by interactive teaching consisting of immediate correction of faulty technique displayed by the child and/or parent. All participants received 2 teaching sessions at initial and 1‐month visits. Devices were MDIs with an Aerochamber, Nebuhaler or Venthaler and DPIs with Diskhaler or Turbuhaler Control summary: Control participants received instruction only by picture diagrams (didactic teaching) given by another nurse, who had no contact with the experimental group. All participants received 2 teaching sessions at initial and 1‐month visits | |
| Outcomes | Outcomes measured: technical ability in inhalation and Likert scales for parental perceptions of treatment at 1, 3 and 6 months (end of study); morbidity assessed at baseline and at 6 months; morbidity evaluated by a questionnaire derived from Beck et al, including number of asthma attacks, number of hospitalisations and duration of stay, number of ED visits, numbers of missed school days and disability days (unable to perform usual activities) Technique assessment method used: assessed by research assistant through direct observation of the child and/or parent administering a placebo aerosol. Score was calculated by using a checklist of essential steps of the technique ‐ 1 point for each correct step. Number of steps differed between devices, so scores were converted into percentages | |
| Notes | Type of publication: single peer‐reviewed journal article Funding: supported by the 'Fondation de l'Hopital Sainte‐Justine' through special funding from the Fonds de la Recherche en Sante de Quebec (FRSQ) and the Interservice Club Council (Telethon of Stars) granted to the Group in Evaluative, Clinical and Epidemiologic Research at the Ste‐Justine Hospital Research Center | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomised into experimental and control groups using a computer generated list of random numbers" |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | Low risk | Participants were evaluated by a research assistant who was blind to the teaching assignment group at baseline and follow‐up visits, and inhalation technique assessed by this person was the main outcome reported. |
| Incomplete outcome data (attrition bias) | High risk | More than 40% dropped out from both arms; although they are reported to not differ significantly from those who completed in terms of baseline demographics, reason for drop ‐out is not given and no flow diagram is presented. No ITT analysis/adjustment for attrition is described |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified. 'Morbidity indices' were collected during follow ‐up (e.g. number of attacks, hospitalisation and days of school missed) but were not fully reported, so could not be included in the meta‐analysis |
| Other bias | Low risk | None noted |
| Study characteristics | ||
| Methods | Design: parallel‐group randomised controlled trial; blinding not stated Duration: 4 weeks Setting: Comprehensive Lung Center, Pittsburgh, Pennsylvania, USA Trial registration: not reported | |
| Participants | Population: 43 people with asthma randomised to face‐to‐face demonstration + in‐check simulator (n = 22) or face‐to‐face demonstration (n = 21) Age: not reported Baseline asthma severity: not reported Inclusion criteria: people with asthma new to the Comprehensive Lung Center Exclusion criteria: not reported Percentage withdrawn: 5% of participants withdrew from the intervention arm, and 10% from the control arm Other allowed medication: not reported | |
| Interventions | Intervention summary: usual teaching with demonstrator models plus In‐Check to simulate resistance and measure inspiratory flow for each specific inhaler used Control summary: usual teaching with demonstrator models | |
| Outcomes | Outcomes measured: inspiratory flow, number of correct steps met Technique assessment method used: In‐Check inspiratory flow | |
| Notes | Type of publication: conference abstract Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Twenty‐one subjects were randomized to traditional teaching (control arm) while 22 received In‐Check" ‐ no further details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) | High risk | No description of procedures intended to blind participants or personnel to group assignment |
| Blinding of outcome assessment (detection bias) | Unclear risk | 'No description of procedures intended to blind outcome assessors to group allocation but the IN‐CHECK device provides an objective measure of inhalation technique" |
| Incomplete outcome data (attrition bias) | Low risk | Less than 10% drop ‐out in both groups |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified. Minimal details as reported as conference abstract only |
| Other bias | Low risk | None noted |
ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; AQOL: asthma quality of life; BAI: breath‐activated inhaler; BTS:British Thoracic Society; DPI: dry powder inhaler; ED: emergency department; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; GINA: Global Initiative for Asthma; HCP: healthcare practitioner; ICS: inhaled corticosteroids; IF: inspiratory flow; ITT: intention‐to‐treat; IVC: inspiratory vital capacity; JMI: Jones Morbidity Index; LABA: long‐acting beta2‐agonist; MDI: metered dose inhaler; MTS: multi‐media touch screen system; PACQLQ: PAQLQ completed by parents of children; PAQLQ: Paediatric Asthma Quality of Life Questionnaire; PEFR: peak expiratory flow rate; PIF: peak inspiratory flow; PIL: patient information leaflet; pMDI: pressurised metered dose inhaler; QOL: quality of life; RA: research assistant; SD: standard deviation; TH: Trainhaler; VC: verbal counselling.
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Not an RCT | |
| Cross‐over study performed during 1 clinic visit. Participants used 2 different inhaler types in a randomised order before and after normal, and then enhanced training with the IN‐CHECK device. Before‐and‐after data presented only | |
| Intervention delivered to pharmacists; focus was pharmacists' knowledge rather than participant outcomes | |
| Mixed population with asthma and COPD; no disaggregated data presented | |
| Healthy participants | |
| Preliminary observational findings from a complex educational intervention. Primary focus of intervention not inhaler technique | |
| Not an RCT | |
| Trial of impact of spacer delivery on bronchodilatation outcomes | |
| Primary focus of intervention not inhaler technique | |
| Primary focus of intervention not inhaler technique | |
| Primary focus of intervention not inhaler technique | |
| Mixed population with asthma and COPD; no disaggregated data presented | |
| Trial of impact of spacer delivery on bronchodilatation outcomes | |
| Primary focus of intervention not inhaler technique | |
| Not stated that participants had asthma; likely mixed population with asthma and COPD judging by age and sex of participants | |
| Mixed population with asthma and COPD; no disaggregated data | |
| Primary focus of intervention not inhaler technique | |
| Not an RCT | |
| Randomised portion of trial involved healthy volunteers | |
| Primary focus of intervention not inhaler technique | |
| Mixed population with asthma and COPD; no disaggregated data | |
| Mixed population with asthma and COPD; no disaggregated data | |
| Subanalysis of a larger trial investigating a multi‐faceted intervention to improve asthma management in older adults. Primary focus of intervention not inhaler technique | |
| Primary focus of intervention not inhaler technique | |
| Primary focus of intervention not inhaler technique | |
| Primary focus of intervention not inhaler technique | |
| Primary focus of intervention not inhaler technique | |
| Primary focus of intervention not inhaler technique | |
| Primary focus of intervention not inhaler technique | |
| Cross‐over study of spacer drug delivery | |
| Cross‐over study primarily assessing impact of spacer delivery on lung function | |
| Not an RCT | |
| Control group but no mention of random allocation | |
| Primary focus of intervention not inhaler technique | |
| Mixed population with asthma and COPD; no disaggregated data | |
| Not an RCT ‐ children used as their own controls | |
| Trial of impact of spacer delivery on bronchodilatation outcomes | |
| Primary focus of intervention not inhaler technique |
COPD: chronic obstructive pulmonary disease; RCT: randomised controlled trial.
Characteristics of studies awaiting classification [ordered by study ID]
| Methods | Open‐label parallel‐group randomised controlled trial |
| Participants | Adults with asthma aged 18 to 75 years receiving step 3 or 4 therapy for asthma as defined by British Thoracic Society (BTS) guidelines (daily doses of BDP‐equivalent ICS ≥ 800 mcg to 2000 mcg as part of fixed or free combinations with long‐acting beta‐agonists (LABAs)) |
| Interventions | Comparison of inhaler technique mastery of Spiromax vs Symbicort Turbohaler |
| Outcomes | Critical and number of errors, adherence, patient satisfaction, exacerbations, change in asthma treatment, adverse events |
| Notes | Study reported as completed in March 2015, but no study results posted on clinicaltrial.gov; we are unable to link record to a full‐text publication |
| Methods | Quasi‐experimental study; a convenience sample of children were "randomly assigned to one of two equal groups" |
| Participants | Children (7 to 12 years of age) with asthma; sample included 154 children (African American and Caucasian) |
| Interventions | Mnemonic device to assist in learning to use the MDI (3 colourful cards with keywords and animated pictures representing MDI use) |
| Outcomes | At 2 points in time, participants answered demographic and medical history questions, had their inhaler technique evaluated, received mnemonic or standard instructions and performed pulmonary function tests. An inhaler checklist measured skill in MDI use |
| Notes | Not clear from the abstract whether this is a truly randomised study. Attempted to contact NK Westhus (lead author) via the University of St Louis; email sent on 26 August 2016; no response received at the time of publication |
BDP: beclomethasone dipropionate; BTS: British Thoracic Society; ICS inhaled corticosteroids; LABA: long‐acting beta‐agonist; MDI: metered dose inhaler.
Characteristics of ongoing studies [ordered by study ID]
| Study name | Assessing the effectiveness of Inhaler Technique Labels on asthma patients' inhaler technique |
| Methods | Parallel‐group randomised controlled trial |
| Participants | People aged 14 to 85 years with a doctor diagnosis of asthma, currently using inhaled corticosteroids with or without long‐acting beta‐agonists via Turbuhaler or Diskus, who have been on the same asthma medication and dose for a minimum of 1 month before study enrolment. Planned recruitment 214 participants |
| Interventions | Inhaler technique labels used as part of inhaler technique education (verbal plus physical demonstration) compared with inhaler technique education alone |
| Outcomes | Inhaler technique, asthma control (using Asthma Control Test) |
| Starting date | 01/08/2009 |
| Contact information | Dr Iman Amin Basheti Email: [email protected] |
| Notes | Listed as 'active but not recruiting'. Unable to link to a full‐text publication |
| Study name | The relationship between asthma management and inhaler technique training |
| Methods | Parallel‐group randomised controlled trial |
| Participants | Adults with asthma aged 20 years and older with an ACT score under 24. Planned recruitment 90 participants |
| Interventions | No inhaler technique training vs inhaler technique training vs inhaler technique training and education |
| Outcomes | Adherence, ACT, FEV1, FeNO |
| Starting date | 01/11/2011 |
| Contact information | Kumiya Sugiyama 880 Kita‐kobayashi Mibu Tochigi 321‐0293 Japan Email: [email protected] |
| Notes | Status listed as 'enrolling by invitation'. Unable to link to a full‐text publication |
| Study name | A protocol for a randomised clinical trial of the effect of providing feedback on inhaler technique and adherence from an electronic device in patients with poorly controlled severe asthma |
| Methods | Single‐blind prospective parallel‐group randomised clinical trial |
| Participants | Patients with partially controlled or uncontrolled severe asthma who have also had at least 1 severe asthma exacerbation in the prior year are eligible to participate. Planned recruitment 220 participants |
| Interventions | Active group will receive feedback on their inhaler technique and adherence with the new device over a 3‐month period. Control group will also receive training in inhaler technique and strategies to promote adherence, but no feedback from the device |
| Outcomes | Adherence, inhaler technique, number who remain poorly controlled despite appropriate technique |
| Starting date | 2011 |
| Contact information | Imran Sulaiman |
| Notes |
| Study name | A randomised, parallel‐group, multi‐centre trial using a novel 'INCA' Tracker Device to measure and monitor compliance and technique of Seretide Diskus inhaler in a community pharmacy setting |
| Methods | Open‐label parallel‐group randomised controlled trial |
| Participants | Adults with asthma or COPD aged 18 years or older with a valid prescription for Seretide Diskus inhaler or currently using a Seretide Diskus inhaler. Planned recruitment 200 participants |
| Interventions | Feedback on the participant's own inhaler use, with personalised information on participant technique and timing of use of the Diskus inhaler as recorded on the INCA device, will be provided to participants in the feedback group after 1, 2 and 6 months vs current best practice inhaler technique education |
| Outcomes | Adherence, inhaler technique, rescue inhaled medication use, rescue antibiotic/steroid use, quality of life |
| Starting date | February 2014 |
| Contact information | Richard Costello Royal College of Surgeons Clinical Research Centre Beuamont Hospital Email: [email protected] |
| Notes |
| Study name | Evaluating the efficacy of 2 different educational strategies for improving and maintaining inhaler technique |
| Methods | Open‐label parallel‐group randomised controlled trial |
| Participants | Adults aged 35 to 90 years whose regular treatment requires inhaled medication. They will be included regardless of age, disease, inhaler device used or cognition |
| Interventions | Structured education on the use of inhalers vs usual standard informal education |
| Outcomes | Inhaler technique |
| Starting date | December 2014 |
| Contact information | Steven Hickey, Respiratory Nurse Specialist Northampton General Hospital NHS Trust |
| Notes |
| Study name | Video vs Teach‐To‐Goal Respiratory Inhaler Technique Assessment and InstructioN (V‐TRaIN) |
| Methods | Single‐blind (outcomes assessor) parallel‐group randomised controlled trial |
| Participants | Adults aged 18 years and older, admitted to the inpatient medical service and surgical service with physician‐diagnosed COPD or asthma. We will enrol patients even if the primary reason for admission is not COPD or asthma (e.g. patients admitted for heart failure but with a physician diagnosis of COPD are eligible) |
| Interventions | Those in the TTG condition will be provided with an intensive, iterative education and evaluation strategy. Those in the video module education condition will be provided with a tablet device and instructions on how to complete video training and self‐assessment |
| Outcomes | Inhaler technique, symptoms, quality of life, self‐efficacy, healthcare utilisation, lung function |
| Starting date | November 2015 |
| Contact information | Susannah Butters Email: [email protected] |
| Notes |
ACT: Asthma Control Test; COPD: chronic obstructive pulmonary disease; FeNO: fractional exhaled nitric oxide; FEV1: forced expiratory volume in one second; TTG: teach‐to‐goal.
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.1 Correct inhaler technique (at follow‐up) Show forest plot | 3 | 258 | Odds Ratio (M‐H, Random, 95% CI) | 5.00 [1.83, 13.65] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.1  Comparison 1: Adults: enhanced education versus control/usual care, Outcome 1: Correct inhaler technique (at follow‐up) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.2 Inhaler technique score Show forest plot | 6 | Other data | No numeric data | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.2
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 2: Inhaler technique score | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.3 Asthma control Show forest plot | 2 | 247 | Std. Mean Difference (IV, Random, 95% CI) | 0.48 [‐0.29, 1.24] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.3  Comparison 1: Adults: enhanced education versus control/usual care, Outcome 3: Asthma control | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.4 Asthma control Show forest plot | 2 | 134 | Odds Ratio (M‐H, Random, 95% CI) | 3.18 [1.47, 6.88] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.4  Comparison 1: Adults: enhanced education versus control/usual care, Outcome 4: Asthma control | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.5 Exacerbations requiring at least OCS Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.5  Comparison 1: Adults: enhanced education versus control/usual care, Outcome 5: Exacerbations requiring at least OCS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.6 Exacerbations requiring ED/hospitalisation Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.6  Comparison 1: Adults: enhanced education versus control/usual care, Outcome 6: Exacerbations requiring ED/hospitalisation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.7 Quality of life Show forest plot | 2 | 247 | Std. Mean Difference (IV, Random, 95% CI) | 0.52 [‐0.04, 1.09] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.7  Comparison 1: Adults: enhanced education versus control/usual care, Outcome 7: Quality of life | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.8 Subgroup analysis: inhaler technique (at follow‐up): to whom intervention is delivered Show forest plot | 3 | 258 | Odds Ratio (M‐H, Random, 95% CI) | 5.00 [1.83, 13.65] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.8  Comparison 1: Adults: enhanced education versus control/usual care, Outcome 8: Subgroup analysis: inhaler technique (at follow‐up): to whom intervention is delivered | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.8.1 Delivered to participants | 2 | 174 | Odds Ratio (M‐H, Random, 95% CI) | 3.03 [1.61, 5.68] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.8.2 Delivered to pharmacists | 1 | 84 | Odds Ratio (M‐H, Random, 95% CI) | 12.38 [4.04, 37.90] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.9 Subgroup analysis: asthma control: to whom intervention is delivered Show forest plot | 2 | 247 | Std. Mean Difference (IV, Random, 95% CI) | 0.48 [‐0.29, 1.24] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.9  Comparison 1: Adults: enhanced education versus control/usual care, Outcome 9: Subgroup analysis: asthma control: to whom intervention is delivered | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.9.1 Delivered to participants | 1 | 150 | Std. Mean Difference (IV, Random, 95% CI) | 0.10 [‐0.22, 0.42] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.9.2 Delivered to pharmacists | 1 | 97 | Std. Mean Difference (IV, Random, 95% CI) | 0.88 [0.46, 1.30] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.10 Subgroup analysis: inhaler technique (at follow‐up): off‐off vs repeated sessions Show forest plot | 3 | 258 | Odds Ratio (M‐H, Random, 95% CI) | 5.00 [1.83, 13.65] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.10  Comparison 1: Adults: enhanced education versus control/usual care, Outcome 10: Subgroup analysis: inhaler technique (at follow‐up): off‐off vs repeated sessions | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.10.1 One‐off | 1 | 24 | Odds Ratio (M‐H, Random, 95% CI) | 3.50 [0.50, 24.56] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1.10.2 Repeated | 2 | 234 | Odds Ratio (M‐H, Random, 95% CI) | 5.64 [1.40, 22.66] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Correct inhaler technique (at follow‐up) Show forest plot | 2 | 175 | Odds Ratio (M‐H, Random, 95% CI) | 1.29 [0.70, 2.36] |
| Analysis 2.1  Comparison 2: Children: enhanced education versus control/usual care, Outcome 1: Correct inhaler technique (at follow‐up) | ||||
| 2.2 Inhaler technique (PIF immediately after intervention) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| Analysis 2.2  Comparison 2: Children: enhanced education versus control/usual care, Outcome 2: Inhaler technique (PIF immediately after intervention) | ||||
| 2.3 Inhaler technique (PIF at follow‐up) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| Analysis 2.3  Comparison 2: Children: enhanced education versus control/usual care, Outcome 3: Inhaler technique (PIF at follow‐up) | ||||
| 2.4 Subgroup analysis: inhaler technique (at follow‐up): one‐off vs repeated sessions Show forest plot | 2 | 175 | Odds Ratio (M‐H, Random, 95% CI) | 1.29 [0.70, 2.36] |
| Analysis 2.4  Comparison 2: Children: enhanced education versus control/usual care, Outcome 4: Subgroup analysis: inhaler technique (at follow‐up): one‐off vs repeated sessions | ||||
| 2.4.1 One‐off | 1 | 120 | Odds Ratio (M‐H, Random, 95% CI) | 1.37 [0.66, 2.83] |
| 2.4.2 Repeated | 1 | 55 | Odds Ratio (M‐H, Random, 95% CI) | 1.11 [0.37, 3.38] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | ||||||||||||||||||||||||||||
| 3.1 Correct inhaler technique (immediately after intervention) Show forest plot | 2 | 164 | Odds Ratio (M‐H, Random, 95% CI) | 2.15 [0.84, 5.50] | ||||||||||||||||||||||||||||
| Analysis 3.1  Comparison 3: Adults: multi‐media training versus control/usual care, Outcome 1: Correct inhaler technique (immediately after intervention) | ||||||||||||||||||||||||||||||||
| 3.2 Correct inhaler technique (at follow‐up) Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |||||||||||||||||||||||||||||
| Analysis 3.2  Comparison 3: Adults: multi‐media training versus control/usual care, Outcome 2: Correct inhaler technique (at follow‐up) | ||||||||||||||||||||||||||||||||
| 3.3 Inhaler technique score Show forest plot | 2 | Other data | No numeric data | |||||||||||||||||||||||||||||
| Analysis 3.3
Comparison 3: Adults: multi‐media training versus control/usual care, Outcome 3: Inhaler technique score | ||||||||||||||||||||||||||||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | ||||||||||||||||||||||||||||||||||
| 4.1 Change in inhaler technique score Show forest plot | 2 | Other data | No numeric data | |||||||||||||||||||||||||||||||||||
| Analysis 4.1
Comparison 4: Children: multi‐media training versus control/usual care, Outcome 1: Change in inhaler technique score | ||||||||||||||||||||||||||||||||||||||
| 4.2 Asthma control (change from baseline) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |||||||||||||||||||||||||||||||||||
| Analysis 4.2  Comparison 4: Children: multi‐media training versus control/usual care, Outcome 2: Asthma control (change from baseline) | ||||||||||||||||||||||||||||||||||||||
| 4.3 Asthma control (endpoint) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |||||||||||||||||||||||||||||||||||
| Analysis 4.3  Comparison 4: Children: multi‐media training versus control/usual care, Outcome 3: Asthma control (endpoint) | ||||||||||||||||||||||||||||||||||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | ||||||||||||||||||
| 5.1 Inhaler technique (PIF) Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |||||||||||||||||||
| Analysis 5.1  Comparison 5: Adults: feedback device versus control/usual care, Outcome 1: Inhaler technique (PIF) | ||||||||||||||||||||||
| 5.2 Correct inhaler technique (at follow‐up) Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |||||||||||||||||||
| Analysis 5.2  Comparison 5: Adults: feedback device versus control/usual care, Outcome 2: Correct inhaler technique (at follow‐up) | ||||||||||||||||||||||
| 5.3 Inhaler technique score Show forest plot | 1 | Other data | No numeric data | |||||||||||||||||||
| Analysis 5.3
Comparison 5: Adults: feedback device versus control/usual care, Outcome 3: Inhaler technique score | ||||||||||||||||||||||
| 5.4 Asthma control Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |||||||||||||||||||
| Analysis 5.4  Comparison 5: Adults: feedback device versus control/usual care, Outcome 4: Asthma control | ||||||||||||||||||||||
| 5.5 Quality of life Show forest plot | 2 | 100 | Mean Difference (IV, Random, 95% CI) | 0.38 [‐0.01, 0.77] | ||||||||||||||||||
| Analysis 5.5  Comparison 5: Adults: feedback device versus control/usual care, Outcome 5: Quality of life | ||||||||||||||||||||||
| 5.6 Quality of life (responders) Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |||||||||||||||||||
| Analysis 5.6  Comparison 5: Adults: feedback device versus control/usual care, Outcome 6: Quality of life (responders) | ||||||||||||||||||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 6.1 Inhaler technique (PIF) Show forest plot | 2 | 98 | Mean Difference (IV, Random, 95% CI) | ‐9.22 [‐33.71, 15.27] |
| Analysis 6.1  Comparison 6: Children: feedback device versus control/usual care, Outcome 1: Inhaler technique (PIF) | ||||
| 6.2 Asthma control Show forest plot | 2 | 98 | Mean Difference (IV, Random, 95% CI) | ‐0.02 [‐0.35, 0.32] |
| Analysis 6.2  Comparison 6: Children: feedback device versus control/usual care, Outcome 2: Asthma control | ||||
| 6.3 Quality of life (change from baseline) Show forest plot | 2 | 91 | Mean Difference (IV, Random, 95% CI) | 0.25 [‐0.07, 0.58] |
| Analysis 6.3  Comparison 6: Children: feedback device versus control/usual care, Outcome 3: Quality of life (change from baseline) | ||||
| 6.4 Quality of life (endpoint) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 6.4  Comparison 6: Children: feedback device versus control/usual care, Outcome 4: Quality of life (endpoint) | ||||
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
In the control group, 31 out of 100 people had correct inhaler technique after 2 to 26 weeks, compared with 69 (95% CI 45 to 86) out of 100 in the active treatment group.
In the control group, 49 out of 100 people had at least 0.5 unit increase in AQLQ after 6 weeks, compared with 83 (95% CI 42 to 94) out of 100 in the active treatment group.
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 1: Correct inhaler technique (at follow‐up)
| Inhaler technique score | |||||
| Study | Time of rating | Intervention mean (SD) | Control mean (SD) | Total N | Scale (higher score= better technique) |
|---|---|---|---|---|---|
| Basheti 2008 | Post‐intervention | ‐ | ‐ | ‐ | ‐ |
| Follow‐up (26 wks) | 2.80 (1.60) | 0.90 (1.40) | 100 | Max 9 (change) | |
| Bynum 2001 | Post‐intervention | 7.33 (0.72) | 5.14 (1.62) | 36 | Max 8 |
| Follow‐up (2 to 4 wks) | 6.73 (1.22) | 4.86 (1.10) | 36 | Max 8 | |
| Mehuys 2008 | Post‐intervention | ‐ | ‐ | ‐ | ‐ |
| Follow‐up (26 wks) | 93.2 (10.7) | 83.7 (22.5) | 150 | Max 100 | |
| Rahmati 2014 | Post‐intervention | 10.8 (0.48) | 5.57 (1.20) | 120 | Max 11 |
| Follow‐up (4 wks) | 10.17 (0.91) | 5.48 (1.27) | 90 | Max 11 | |
| Rydman 1999 | Post‐intervention | 0.68 (0.46) | 0.60 (0.49) | 120 | Max 1 |
| Follow‐up (8 to 20 wks) | 0.72 (0.45) | 0.75 (0.43) | 120 | Max 1 | |
| Self 1983 | Post‐intervention | 16.8 (4.1) | 10.7 (5.4) | 19 | Max 20 |
| Follow‐up | ‐ | ‐ | ‐ | ‐ | |
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 2: Inhaler technique score
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 3: Asthma control
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 4: Asthma control
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 5: Exacerbations requiring at least OCS
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 6: Exacerbations requiring ED/hospitalisation
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 7: Quality of life
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 8: Subgroup analysis: inhaler technique (at follow‐up): to whom intervention is delivered
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 9: Subgroup analysis: asthma control: to whom intervention is delivered
Comparison 1: Adults: enhanced education versus control/usual care, Outcome 10: Subgroup analysis: inhaler technique (at follow‐up): off‐off vs repeated sessions
Comparison 2: Children: enhanced education versus control/usual care, Outcome 1: Correct inhaler technique (at follow‐up)
Comparison 2: Children: enhanced education versus control/usual care, Outcome 2: Inhaler technique (PIF immediately after intervention)
Comparison 2: Children: enhanced education versus control/usual care, Outcome 3: Inhaler technique (PIF at follow‐up)
Comparison 2: Children: enhanced education versus control/usual care, Outcome 4: Subgroup analysis: inhaler technique (at follow‐up): one‐off vs repeated sessions
Comparison 3: Adults: multi‐media training versus control/usual care, Outcome 1: Correct inhaler technique (immediately after intervention)
Comparison 3: Adults: multi‐media training versus control/usual care, Outcome 2: Correct inhaler technique (at follow‐up)
| Inhaler technique score | ||||
| Study | Time of rating | MD (SE) | Total N | Scale (higher score= better technique) |
|---|---|---|---|---|
| Acosta 2009 | Post‐intervention | 14.77 (2.23) | 116 | % correct use |
| Follow‐up (4 wks) | 13.30 (2.33) | 116 | % correct use | |
| Self 1983 | Post‐intervention | 6.2 (2.33) | 20 | Max 20 |
| Follow‐up (4 wks) | Control not followed‐up | ‐ | Max 20 | |
Comparison 3: Adults: multi‐media training versus control/usual care, Outcome 3: Inhaler technique score
| Change in inhaler technique score | |||||
| Study | Time of rating | Intervention mean (SD) | Control mean (SD) | Total N | Scale (higher score= better technique) |
|---|---|---|---|---|---|
| Boone 2002 | Post‐intervention | ‐ | ‐ | ‐ | ‐ |
| Follow‐up (4 wks) | 2.60 (0.60) | 0.50 (0.50) | 36 | Max 15 | |
| Carpenter 2015 | Post‐intervention | 1.12 (1.09) | 0.03 (1.07) | 91 | Max 8 |
| Follow‐up (4 wks) | 0.87 (1.09) | 0.32 (1.14) | 91 | Max 8 | |
Comparison 4: Children: multi‐media training versus control/usual care, Outcome 1: Change in inhaler technique score
Comparison 4: Children: multi‐media training versus control/usual care, Outcome 2: Asthma control (change from baseline)
Comparison 4: Children: multi‐media training versus control/usual care, Outcome 3: Asthma control (endpoint)
Comparison 5: Adults: feedback device versus control/usual care, Outcome 1: Inhaler technique (PIF)
Comparison 5: Adults: feedback device versus control/usual care, Outcome 2: Correct inhaler technique (at follow‐up)
| Inhaler technique score | |||||
| Study | Time of rating | Intervention mean (SD) | Control mean (SD) | Total N | Scale (higher score= better technique) |
|---|---|---|---|---|---|
| Toumas‐Shehata 2014 | Follow‐up (4 wks) | 9.50 (1.00) | 8.90 (1.00) | 97 | Max 10 or 11 |
Comparison 5: Adults: feedback device versus control/usual care, Outcome 3: Inhaler technique score
Comparison 5: Adults: feedback device versus control/usual care, Outcome 4: Asthma control
Comparison 5: Adults: feedback device versus control/usual care, Outcome 5: Quality of life
Comparison 5: Adults: feedback device versus control/usual care, Outcome 6: Quality of life (responders)
Comparison 6: Children: feedback device versus control/usual care, Outcome 1: Inhaler technique (PIF)
Comparison 6: Children: feedback device versus control/usual care, Outcome 2: Asthma control
Comparison 6: Children: feedback device versus control/usual care, Outcome 3: Quality of life (change from baseline)
Comparison 6: Children: feedback device versus control/usual care, Outcome 4: Quality of life (endpoint)
| Enhanced education compared with control/usual care for people with asthma | |||||||
| Patient or population: adults and children with asthma | |||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | ||
|---|---|---|---|---|---|---|---|
| Risk with control/usual care | Risk with enhanced education | ||||||
| Correct inhaler technique Follow‐up: 2 to 26 weeks (adults) 12 to 26 weeks (children) | Adults | 31 per 100 | 69 per 100 | OR 5.00 (1.83 to 13.65) | 258 | ⊕⊕⊕⊝ MODERATEa | Additional results from technique rating scales could not be combined (Analysis 1.2) |
| Children | 49 per 100 | 55 per 1,00 | OR 1.29 | 175 | ⊕⊕⊝⊝ LOWa,b | One study measured PIF as a marker for inhaler technique and showed benefit (Analysis 2.2; Analysis 2.3) | |
| Asthma control score 4 to 26 weeks | Adults | ‐ | Score in the intervention group was 0.48 SDs higher than in the control group | ‐ | 247 | ⊕⊝⊝⊝ VERY LOWa,b,c | We were not able to calculate a control risk, as the outcome was measured on different scales |
| Asthma control responders 8 to 12 weeks | Adults | 42 per 100 | 70 per 100 | OR 3.18 | 134 | ⊕⊕⊝⊝ LOWd | |
| Exacerbations requiring at least OCS 26 weeks | Adults | 10 per 100 | 13 per 100 (5 to 28) | OR 1.32 (0.49 to 3.55) | 158 (1 RCT) | ⊕⊕⊝⊝ LOWa,b | The same study also reported exacerbations requiring ED/hospitalisation. Events were rare and results imprecise |
| Quality of life 26 weeks | Adults | ‐ | Score in the intervention group was 0.52 SDs higher than in the control group | ‐ | 247 | ⊕⊕⊝⊝ LOWa,c,e | We were not able to calculate a control risk as the outcome was measured on different scales |
| Other outcomes | No results could be analysed for adverse events, unscheduled visits to a healthcare provider or school/work absences | ||||||
| *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) | |||||||
| GRADE Working Group grades of evidence | |||||||
| aStudies contributing to this outcome were at high risk of bias in several domains (including performance and detection bias). Downgraded once bWide confidence intervals including possible harm and benefit of intervention. Downgraded once cHigh level of statistical inconsistency detected. Downgraded once dThe two small studies contributing to this outcome were identified as abstracts only; it is therefore difficult to assess methodological quality. Studies were considered at high or unclear risk of bias in multiple domains (including selection, performance, detection and reporting biases). Downgraded twice eConfidence interval includes no difference with random‐effects model, driven by statistical heterogeneity. Fixed‐effect sensitivity analysis yields more precise result. Not downgraded | |||||||
| Multimedia training compared with control/usual care for people with asthma | |||||||
| Patient or population: adults and children with asthma | |||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | ||
|---|---|---|---|---|---|---|---|
| Risk with control/usual care | Risk with multi‐media training | ||||||
| Correct inhaler technique Immediately after intervention | Adults | 30 per 100 | 47 per 100 | OR 2.15 | 164 | ⊕⊕⊕⊝ MODERATEa,b | |
| Correct inhaler technique 2‐Week follow‐up | Adults | 43 per 100 | 57 per 100 | OR 1.78 | 28 | ⊕⊕⊝⊝ LOWa,c | |
| Inhaler technique score | Adults | Not pooled; narrative summary of evidence provided in data table (Analysis 3.3) | ‐ | 136 (2 RCTs) | Not graded | Suggests benefit of multi‐media training over control | |
| Children | Not pooled; narrative summary of evidence provided in data table (Analysis 4.1) | ‐ | 127 (2 RCTs) | Not graded | Suggests benefit of multi‐media training over control | ||
| Asthma control (ACT) 4 weeks | Children | Mean change in control group was 1.2 | Mean change was 0.73 better (‐0.99 worse to 2.45 better) | ‐ | 91 (1 RCT) | ⊕⊕⊝⊝ LOWa,c | |
| Other outcomes | No results could be analysed for quality of life, exacerbations, adverse events, unscheduled visits to a healthcare provider or school/work absences | ||||||
| *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) | |||||||
| GRADE Working Group grades of evidence | |||||||
| aConfidence intervals include no difference. Downgraded once bAlthough participants in both studies were unblinded, inhaler technique was rated by a blinded assessor, and both groups received an intervention. Not downgraded cHigh risk of bias for performance and detection. Downgraded once | |||||||
| Feedback device compared with control/usual care for people with asthma | |||||||
| Patient or population: adults and children with asthma | |||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | ||
|---|---|---|---|---|---|---|---|
| Risk with control/usual care | Risk with feedback device | ||||||
| Correct inhaler technique 4‐Week follow‐up | Adults | 51 per 100 | 83 per 100 (66 to 93) | OR 4.80 (1.87 to 12.33) | 97 (1 RCT) | ⊕⊕⊝⊝ LOWa,b | Additional results from technique rating scales could not be combined (Analysis 5.3) |
| Inhaler technique (PIF) Follow‐up: 6 weeks (adults) 6 to 12 weeks (children) | Adults | 66 per 100 | 97 per 100 | OR 18.26 | 71 | ⊕⊕⊝⊝ LOWa,b | |
| Children | Mean PIF was 51.2 litres/min | Mean PIF was 9.22 litres/min better (33.71 better to 15.27 worse) | ‐ | 98 | ⊕⊕⊝⊝ LOWa,c | ||
| Asthma control (ACQ) 6 to 12 weeks | Adults | Mean ACQ score was 1.4 | Mean score in the intervention group was 0.1 better (0.46 better to 0.26 worse) | ‐ | 97 (1 RCT) | ⊕⊕⊝⊝ LOWa,c | |
| Children | Mean ACQ score was 0.7 | Mean score in the intervention group was 0.02 worse | ‐ | 98 | ⊕⊕⊕⊝ MODERATEa | ||
| Quality of life Follow‐up: 6 weeks (adults) 6 to 12 weeks (children) | Adults | Mean score on the mini‐AQLQ was 4.2 | Mean score in the intervention group was 0.38 better | ‐ | 100 | ⊕⊕⊝⊝ LOWa,d | |
| Children | Mean change in quality of life was 0.07 | Mean change was 0.25 better | ‐ | 91 | ⊕⊕⊝⊝ LOWa,d | One study reported endpoint quality of life (Analysis 6.4) | |
| Quality of life (responders) 6 weeks | Adults | 49 per 100 | 83 per 100 | OR 5.29 | 71 | ⊕⊕⊕⊝ MODERATEa | |
| Other outcomes | No results could be analysed for exacerbations, adverse events, unscheduled visits to a healthcare provider or school/work absences | ||||||
| *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) | |||||||
| GRADE Working Group grades of evidence | |||||||
| aHigh risk of performance and detection bias. Downgraded once bVery wide confidence intervals based on one study. Downgraded once cConfidence intervals include possible harm and benefit of the intervention. Downgraded once dConfidence interval does not exclude no difference, and upper limit exceeds the MCID of 0.5 units. Downgraded once | |||||||
| Study ID | Total n | Study duration (weeks) | Age | Country | Intervention | Control | Inhaler technique measure | Outcomes |
|---|---|---|---|---|---|---|---|---|
| 72 | 2 | Children aged 3 to 5 years | Denmark | Instructional video + individual training; delivered to participant | Instructional video | PIF | PIF, IVC, PEFR, FEV1, FVC | |
| 26 | 2 | Adults | Australia | Group B: verbal counselling Group C: verbal counselling + physical demonstration; delivered to participant | Group A: printed materials | 9‐Step Turbuhaler checklist | Inhaler technique | |
| 31 pharmacists, 97 participants | 26 | Adults | Australia | Pharmacist‐participant education + inhaler technique labels; delivered to pharmacist | Peak flow measurement training | 9‐Step checklist | Inhaler technique, asthma severity, peak flow variability, AQOL, perceived control | |
| 49 | 4 | Adolescents aged 12 to 19 years | USA | Telepharmacy counselling; delivered to participant | Written instructions only | 8‐Step MDI checklist | Inhaler technique, participant satisfaction | |
| 89 | 12 | Adults | Not reported | Respiratory therapist education; delivered to participant | Rotuine physician education | Not reported | Inhaler technique, asthma control | |
| 201 | 26 | Adults | Belgium | Pharmacist education; delivered to pharmacist | Usual pharmacy care | 10‐Step MDI + spacer checklist/8‐step DPI checklist | Inhaler technique, ACT, exacerbations, ED/hospital visits, adherence, AQLQ, asthma knowledge | |
| 46 | 8.7 | Adults | Iran | Face‐to‐face education; delivered to participant | Usual care (no further details) | Not reported | ACT, FEV1 | |
| 130 | 12 | Children | Turkey | Face‐to‐face nurse training; delivered to participant | Inhaler package insert only | 10‐Step MDI checklist | Inhaler technique, PAQLQ, spirometry | |
| 90 | 4 | Adults | Iran | Face‐to‐face training (no spacer device); delivered to participant | Usual care (no training) | 11‐Step MDI checklist | Inhaler technique, PEFR | |
| 68 | 8 to 20 | Adults | USA | Face‐to‐face training + demonstration; delivered to participant | Inhaler package insert only | Checklist, converted to score out of 1 (0 if any steps missed) | BAI and MDI competency | |
| 29 | 1 to 16 (mean 6) | Adults | USA | Face‐to‐face pharmacist training; delivered to participant | Inhaler package insert only | 10‐Step checklist | Inhaler technique, "effectiveness of instruction" | |
| 96 | 26 | Children and adolescents (max 15 years) | Canada | Interactive nurse training with feedback; delivered to participant | Pictorial nurse training only | Checklist with scores converted to percentages | Inhaler technique, parental perceptions of treatment, asthma morbidity (e.g. no. of exacerbations, ED visits, hospitalisations, days of schools missed) | |
| ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; AQOL: asthma quality of life; BAI: breath‐activated inhaler; DPI: dry powder inhaler; ED: emergency department; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; IVC: inspiratory vital capacity; MDI: metered dose inhaler; PAQLQ: paediatric AQLQ; PEFR: peak expiratory flow rate; PIF: peak inspiratory flow | ||||||||
| Study ID | Total n | Study duration (weeks) | Age | Country | Intervention | Control | Inhaler technique measure | Outcomes |
|---|---|---|---|---|---|---|---|---|
| 133 | 4 | Adults | USA | Inhaler technique training video; delivered to participant | Asthma education video | Not reported | "Correct usage" of inhaler | |
| 21 | 13 | Children | Ireland | Inhaler technique DVD; delivered to participant | Individual instruction | New inhaler technique measurement tool | Inhaler technique, self‐efficacy, knowledge acquisition | |
| 36 | 4.3 | Children | UK | Inhaler technique educational computer software ("Space Inhalers"); delivered to participant | Placebo software | 15‐Step checklist | Inhaler technique, asthma knowledge | |
| 91 | 4.3 | Children and adolescents | USA | Inhaler technique video; delivered to participant | Attention control video (about nutrition) | 8‐Step checklist | Inhaler technique, self‐efficacy, ACT | |
| 69 | Outcomes assessed immediately | Adults | UK (Turkish‐ speaking population) | Multi‐media touch screen training; delivered to participant | Patient information leaflet plus verbal training | Inhaler checklist | Inhaler technique | |
| 45 | 2.1 | Adults and children (10 to 71 years) | France | Inhaler technique video OR inhaler technique video + spacer; delivered to participant | Patient information sheet | 4‐Step checklist | Inhaler technique, FEV1 | |
| 110 | Outcomes assessed immediately | Children and adults (12 to 87 years) | UK | Multi‐media touch screen training; delivered to participant | Patient information leaflet | Inhaler checklist, global assessment of technique | Inhaler technique, acceptability | |
| 29 | 1 to 16 (mean 6) | Adults | USA | Video training; delivered to participant | Inhaler package insert only | 10‐Step checklist | Inhaler technique, "effectiveness of instruction" | |
| 50 | Not reported | Not reported | USA | Computer training; delivered to participant | Written training OR no training | "Fixed rubric" used to give a score | Inhaler technique | |
| ACT: Asthma Control Test; DVD: digital versatile disc; FEV1: forced expiratory volume in one second | ||||||||
| Study ID | Total n | Study duration (weeks) | Age | Country | Intervention | Control | Inhaler technique measure | Outcomes |
|---|---|---|---|---|---|---|---|---|
| 108 | 6 | Adults | UK | Verbal training + 2Tone trainer; delivered to participant | Verbal training alone | PIF | PIF, FEV1, AQLQ | |
| 56 | 6 | Adults and children (4 to 55 years) | UK | Verbal training + 2Tone trainer; delivered to participant | Verbal training alone | PIF | PIF, FEV1, AQLQ/PAQLQ | |
| 80 | 12 | Children | UK | AeroChamber Plus with Flo‐Vu; delivered to participant | AeroChamber Plus alone | PIF | PIF, PAQLQ, ACQ, parent spacer preference | |
| 30 | 6 to 8 | Children | Not reported | Verbal training and use of Trainhaler; delivered to participant | Verbal training alone | PIF | PIF, ACQ | |
| 90 | 4 | Adults | Iran | Face‐to‐face training (with spacer device); delivered to participant | Usual care (no training) | 11‐Step MDI checklist | Inhaler technique, PEFR | |
| 132 | 52 | Children | Australia | Funhaler incentive device; delivered to participant | AeroChamber device | Filter used to measure salbutamol deposition | Inhaler technique, asthma control, quality of life | |
| 76 | 4 | Not reported | Libya | Verbal training + 2Tone trainer; delivered to participant | Verbal training alone | PIF | PIF, FEV1, AQLQ, Jones Morbidity Index (JMI) | |
| 19 pharmacists (101 participants) | 4 | Adults | Australia | Verbal training + quantitative inhaler feedback; delivered to pharmacist | Verbal training alone | Inhaler checklist/proportion with correct technique | Inhaler technique, ACQ | |
| 43 | 4 | Not reported | USA | Face‐to‐face demonstration + In‐Check simulator; delivered to participant | Face‐to‐face demonstration | PIF, inhaler checklist | PIF, inhaler technique | |
| ACQ: Asthma Control Questionnaire; AQLQ: Asthma Quality of Life Questionnaire; FEV1: forced expiratory volume in one second; MDI: metered dose inhaler; PAQLQ: paediatric AQLQ; PEFR: peak expiratory flow rate; PIF: peak inspiratory flow | ||||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Correct inhaler technique (at follow‐up) Show forest plot | 3 | 258 | Odds Ratio (M‐H, Random, 95% CI) | 5.00 [1.83, 13.65] |
| 1.2 Inhaler technique score Show forest plot | 6 | Other data | No numeric data | |
| 1.3 Asthma control Show forest plot | 2 | 247 | Std. Mean Difference (IV, Random, 95% CI) | 0.48 [‐0.29, 1.24] |
| 1.4 Asthma control Show forest plot | 2 | 134 | Odds Ratio (M‐H, Random, 95% CI) | 3.18 [1.47, 6.88] |
| 1.5 Exacerbations requiring at least OCS Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 1.6 Exacerbations requiring ED/hospitalisation Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 1.7 Quality of life Show forest plot | 2 | 247 | Std. Mean Difference (IV, Random, 95% CI) | 0.52 [‐0.04, 1.09] |
| 1.8 Subgroup analysis: inhaler technique (at follow‐up): to whom intervention is delivered Show forest plot | 3 | 258 | Odds Ratio (M‐H, Random, 95% CI) | 5.00 [1.83, 13.65] |
| 1.8.1 Delivered to participants | 2 | 174 | Odds Ratio (M‐H, Random, 95% CI) | 3.03 [1.61, 5.68] |
| 1.8.2 Delivered to pharmacists | 1 | 84 | Odds Ratio (M‐H, Random, 95% CI) | 12.38 [4.04, 37.90] |
| 1.9 Subgroup analysis: asthma control: to whom intervention is delivered Show forest plot | 2 | 247 | Std. Mean Difference (IV, Random, 95% CI) | 0.48 [‐0.29, 1.24] |
| 1.9.1 Delivered to participants | 1 | 150 | Std. Mean Difference (IV, Random, 95% CI) | 0.10 [‐0.22, 0.42] |
| 1.9.2 Delivered to pharmacists | 1 | 97 | Std. Mean Difference (IV, Random, 95% CI) | 0.88 [0.46, 1.30] |
| 1.10 Subgroup analysis: inhaler technique (at follow‐up): off‐off vs repeated sessions Show forest plot | 3 | 258 | Odds Ratio (M‐H, Random, 95% CI) | 5.00 [1.83, 13.65] |
| 1.10.1 One‐off | 1 | 24 | Odds Ratio (M‐H, Random, 95% CI) | 3.50 [0.50, 24.56] |
| 1.10.2 Repeated | 2 | 234 | Odds Ratio (M‐H, Random, 95% CI) | 5.64 [1.40, 22.66] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Correct inhaler technique (at follow‐up) Show forest plot | 2 | 175 | Odds Ratio (M‐H, Random, 95% CI) | 1.29 [0.70, 2.36] |
| 2.2 Inhaler technique (PIF immediately after intervention) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 2.3 Inhaler technique (PIF at follow‐up) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 2.4 Subgroup analysis: inhaler technique (at follow‐up): one‐off vs repeated sessions Show forest plot | 2 | 175 | Odds Ratio (M‐H, Random, 95% CI) | 1.29 [0.70, 2.36] |
| 2.4.1 One‐off | 1 | 120 | Odds Ratio (M‐H, Random, 95% CI) | 1.37 [0.66, 2.83] |
| 2.4.2 Repeated | 1 | 55 | Odds Ratio (M‐H, Random, 95% CI) | 1.11 [0.37, 3.38] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Correct inhaler technique (immediately after intervention) Show forest plot | 2 | 164 | Odds Ratio (M‐H, Random, 95% CI) | 2.15 [0.84, 5.50] |
| 3.2 Correct inhaler technique (at follow‐up) Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 3.3 Inhaler technique score Show forest plot | 2 | Other data | No numeric data | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Change in inhaler technique score Show forest plot | 2 | Other data | No numeric data | |
| 4.2 Asthma control (change from baseline) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 4.3 Asthma control (endpoint) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 5.1 Inhaler technique (PIF) Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 5.2 Correct inhaler technique (at follow‐up) Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 5.3 Inhaler technique score Show forest plot | 1 | Other data | No numeric data | |
| 5.4 Asthma control Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 5.5 Quality of life Show forest plot | 2 | 100 | Mean Difference (IV, Random, 95% CI) | 0.38 [‐0.01, 0.77] |
| 5.6 Quality of life (responders) Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 6.1 Inhaler technique (PIF) Show forest plot | 2 | 98 | Mean Difference (IV, Random, 95% CI) | ‐9.22 [‐33.71, 15.27] |
| 6.2 Asthma control Show forest plot | 2 | 98 | Mean Difference (IV, Random, 95% CI) | ‐0.02 [‐0.35, 0.32] |
| 6.3 Quality of life (change from baseline) Show forest plot | 2 | 91 | Mean Difference (IV, Random, 95% CI) | 0.25 [‐0.07, 0.58] |
| 6.4 Quality of life (endpoint) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
