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Cochrane Database of Systematic Reviews

Intervenciones para mejorar el cumplimiento con los corticosteroides inhalados para el asma

Información

DOI:
https://doi.org/10.1002/14651858.CD012226.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 18 abril 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Vías respiratorias

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Rebecca Normansell

    Correspondencia a: Cochrane Airways, Population Health Research Institute, St George's, University of London, London, UK

    [email protected]

  • Kayleigh M Kew

    British Medical Journal Technology Assessment Group (BMJ‐TAG), BMJ Knowledge Centre, London, UK

  • Elizabeth Stovold

    Population Health Research Institute, St George's, University of London, London, UK

Contributions of authors

RN drafted the Background and Methods section according to the Cochrane Airways Group template, with input and revisions from KK and ES. ES ran the electronic searches. All three review authors contributed to sifting of search results, data extraction and assessment of risk of bias in duplicate. RN and KK ran the data analyses and graded the evidence. All review authors contributed to the write‐up.

Sources of support

Internal sources

  • Kayleigh Kew, UK.

    St George's, University of London

  • Rebecca Normansell, UK.

    St George's, University of London

  • Elizabeth Stovold, UK.

    St George's, University of London

External sources

  • National Institute for Health Research, UK.

    Evidence to guide care in adults and children with asthma, 13/89/14

    This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure, Cochrane Programme Grant or Cochrane Incentive funding to the Airways Group. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, the National Health Service (NHS) or the Department of Health

Declarations of interest

RN is the Deputy Co‐ordinating Editor of the Cochrane Airways Group and is a qualified general practitioner.

ES is the Information Specialist for the Cochrane Airways Group.

KK is a systematic review author who was employed by a Cochrane Airways Programme Grant at the time of writing of this review.

Acknowledgements

Julia Walters was the Editor for this review and commented critically on the review.

The Background and Methods sections of this review are based on a standard template used by the Cochrane Airways Group.

We would like to thank Juliet Foster and Wei Xuan for providing the intracluster correlation coefficient for Foster 2014.

Version history

Published

Title

Stage

Authors

Version

2017 Apr 18

Interventions to improve adherence to inhaled steroids for asthma

Review

Rebecca Normansell, Kayleigh M Kew, Elizabeth Stovold

https://doi.org/10.1002/14651858.CD012226.pub2

2016 Jun 06

Interventions to improve adherence to inhaled steroids for asthma

Protocol

Kayleigh M Kew, Rebecca Normansell, Elizabeth Stovold

https://doi.org/10.1002/14651858.CD012226

Differences between protocol and review

We did not use Covidence to extract data from the included studies because we found the process too time consuming, and we were unable to capture different types of data using the software. Instead, we used an Excel template commonly used by the Cochrane Airways Group to capture study characteristics, outcome data and risk of bias information.

In the protocol, we listed various factors that may alter the treatment effect; we intended to present these factors in an additional table. We anticipated that the factors listed (type, delivery, dose and schedule of ICS; whether treatment was given in a combination inhaler with a long‐acting beta‐agonist (LABA), baseline severity of asthma) would document differences between studies, but in practice, studies generally were not designed to assess adherence to a particular type of ICS, dose or regimen, with or without a LABA, so we did not design the table in this way. We have described these factors in the description of studies, and we have presented important clinical and intervention characteristics in Tables 1 to 3.

We had to define post hoc as what constituted an 'objective' measure of adherence. Studies used a variety of measures including self‐report scales, pharmacy refill data, canister weight and electronic monitors. We decided that only electronic monitors could be considered truly objective. In a post hoc change to our analysis plan, we presented studies using objective measures (i.e. electronic inhaler monitors) as the primary analysis for % adherence, as we deemed this a more useful analysis. An analysis including studies that used all measures then follows.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

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

Funnel plot of comparison: 1 Adherence education vs controls, outcome: 1.2 % Adherence (all measures).
Figuras y tablas -
Figure 3

Funnel plot of comparison: 1 Adherence education vs controls, outcome: 1.2 % Adherence (all measures).

Comparison 1 Adherence education versus controls, Outcome 1 % Adherence (objective measures).
Figuras y tablas -
Analysis 1.1

Comparison 1 Adherence education versus controls, Outcome 1 % Adherence (objective measures).

Comparison 1 Adherence education versus controls, Outcome 2 % Adherence (all measures).
Figuras y tablas -
Analysis 1.2

Comparison 1 Adherence education versus controls, Outcome 2 % Adherence (all measures).

Comparison 1 Adherence education versus controls, Outcome 3 > 85% adherence.
Figuras y tablas -
Analysis 1.3

Comparison 1 Adherence education versus controls, Outcome 3 > 85% adherence.

Comparison 1 Adherence education versus controls, Outcome 4 Exacerbations requiring OCS (people with 1 or more).
Figuras y tablas -
Analysis 1.4

Comparison 1 Adherence education versus controls, Outcome 4 Exacerbations requiring OCS (people with 1 or more).

Comparison 1 Adherence education versus controls, Outcome 5 Asthma control.
Figuras y tablas -
Analysis 1.5

Comparison 1 Adherence education versus controls, Outcome 5 Asthma control.

Comparison 1 Adherence education versus controls, Outcome 6 Unsheduled visits to a healthcare provider (people with 1 or more).
Figuras y tablas -
Analysis 1.6

Comparison 1 Adherence education versus controls, Outcome 6 Unsheduled visits to a healthcare provider (people with 1 or more).

Comparison 1 Adherence education versus controls, Outcome 7 Quality of life (AQLQ).
Figuras y tablas -
Analysis 1.7

Comparison 1 Adherence education versus controls, Outcome 7 Quality of life (AQLQ).

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 1 % Adherence (objective measures).
Figuras y tablas -
Analysis 2.1

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 1 % Adherence (objective measures).

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 2 % Adherence (all measures).
Figuras y tablas -
Analysis 2.2

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 2 % Adherence (all measures).

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 3 Exacerbations requiring OCS (people with at least 1).
Figuras y tablas -
Analysis 2.3

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 3 Exacerbations requiring OCS (people with at least 1).

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 4 Asthma control.
Figuras y tablas -
Analysis 2.4

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 4 Asthma control.

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 5 Unscheduled visits to a healthcare provider.
Figuras y tablas -
Analysis 2.5

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 5 Unscheduled visits to a healthcare provider.

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 6 Unscheduled visits to a healthcare provider.
Figuras y tablas -
Analysis 2.6

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 6 Unscheduled visits to a healthcare provider.

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 7 Absenteeism.
Figuras y tablas -
Analysis 2.7

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 7 Absenteeism.

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 8 Absenteeism.
Figuras y tablas -
Analysis 2.8

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 8 Absenteeism.

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 9 Quality of life (AQLQ).
Figuras y tablas -
Analysis 2.9

Comparison 2 Electronic trackers or reminders (± feedback) versus controls, Outcome 9 Quality of life (AQLQ).

Comparison 3 Simplified versus usual regimens, Outcome 1 % Adherence.
Figuras y tablas -
Analysis 3.1

Comparison 3 Simplified versus usual regimens, Outcome 1 % Adherence.

Comparison 3 Simplified versus usual regimens, Outcome 2 Exacerbations requiring OCS.
Figuras y tablas -
Analysis 3.2

Comparison 3 Simplified versus usual regimens, Outcome 2 Exacerbations requiring OCS.

Comparison 3 Simplified versus usual regimens, Outcome 3 Asthma control (ACQ).
Figuras y tablas -
Analysis 3.3

Comparison 3 Simplified versus usual regimens, Outcome 3 Asthma control (ACQ).

Comparison 3 Simplified versus usual regimens, Outcome 4 Unscheduled visits.
Figuras y tablas -
Analysis 3.4

Comparison 3 Simplified versus usual regimens, Outcome 4 Unscheduled visits.

Comparison 3 Simplified versus usual regimens, Outcome 5 Absence from work/school.
Figuras y tablas -
Analysis 3.5

Comparison 3 Simplified versus usual regimens, Outcome 5 Absence from work/school.

Comparison 3 Simplified versus usual regimens, Outcome 6 Quality of life (ITG‐ASF % change from baseline).
Figuras y tablas -
Analysis 3.6

Comparison 3 Simplified versus usual regimens, Outcome 6 Quality of life (ITG‐ASF % change from baseline).

Comparison 3 Simplified versus usual regimens, Outcome 7 All adverse events.
Figuras y tablas -
Analysis 3.7

Comparison 3 Simplified versus usual regimens, Outcome 7 All adverse events.

Comparison 4 School‐based ICS therapy versus controls, Outcome 1 Unscheduled visits (1 or more hospitalisations for any cause).
Figuras y tablas -
Analysis 4.1

Comparison 4 School‐based ICS therapy versus controls, Outcome 1 Unscheduled visits (1 or more hospitalisations for any cause).

Comparison 4 School‐based ICS therapy versus controls, Outcome 2 Quality of life (PAQLQ).
Figuras y tablas -
Analysis 4.2

Comparison 4 School‐based ICS therapy versus controls, Outcome 2 Quality of life (PAQLQ).

Comparison 5 Subgroup analyses for % adherence, Outcome 1 Comparison 1. Children vs adults.
Figuras y tablas -
Analysis 5.1

Comparison 5 Subgroup analyses for % adherence, Outcome 1 Comparison 1. Children vs adults.

Comparison 5 Subgroup analyses for % adherence, Outcome 2 Comparison 2. Complex vs simple interventions.
Figuras y tablas -
Analysis 5.2

Comparison 5 Subgroup analyses for % adherence, Outcome 2 Comparison 2. Complex vs simple interventions.

Comparison 5 Subgroup analyses for % adherence, Outcome 3 Comparison 2. Children vs adults.
Figuras y tablas -
Analysis 5.3

Comparison 5 Subgroup analyses for % adherence, Outcome 3 Comparison 2. Children vs adults.

Summary of findings for the main comparison. Adherence education compared with controls for asthma

Adherence education compared with controls for asthma

Patient or population: asthma
Setting: community
Intervention: adherence education
Comparison: control group (no education)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with controls

Risk with adherence education

% Adherence

WMD of follow‐up 71.7 weeks (all studies)

Objective measures

Mean adherence in the control group was 46.7%

Mean adherence with adherence education was 20.13% higher (7.52 higher to 32.74 higher)

280

(5 RCTs)

⊕⊕⊝⊝
LOWa,b,c

Only studies in which adherence was measured with an electronic monitor

All measures

Mean adherence in the control group was 57.1%

Mean adherence with adherence education was 11.59% higher (3.72 higher to 19.46 higher)

1693
(10 RCTs)

⊕⊕⊝⊝
LOWa,b,c

Exacerbations requiring OCS

(people with 1 or more)

WMD of follow‐up 30.8 weeks

149 per 1000

242 per 1000

(148 to 370)

OR 1.82
(0.99 to 3.36)

349
(3 RCTs)

⊕⊕⊝⊝
LOWa,d

Asthma control (ACQ)

WMD of follow‐up 28.5 weeks

Mean ACQ score was 1.52

Mean score with adherence education was 0.03 better (0.49 better to 0.43 worse)

455
(4 RCTs)

⊕⊕⊕⊝
MODERATEa,e

Lower score indicates better control. Scale 0 to 6. MCID 0.5

Asthma control (ACT)

WMD of follow‐up 29.5 weeks

Mean ACT score was 18.88

Mean score with adherence education was 0.30 better
(1.43 better to 0.82 worse)

333
(3 RCTs)

⊕⊕⊕⊝
MODERATEa,e

Higher score indicates better control. Scale 5 to 25. MCID 3

Unsheduled visits to a healthcare provider

(people with 1 or more)

WMD of follow‐up 67.2 weeks

159 per 1000

83 per 1000
(35 to 184)

OR 0.48
(0.19 to 1.19)

688
(4 RCTs)

⊕⊝⊝⊝
VERY LOWa,b,d,f

Includes visits to ED, GP, hospital for any cause

Absenteeism

WMD of follow‐up 63.3 weeks

We did not perform an analysis of absences because the data were heavily skewed

109
(2 RCTs)

Not graded

Quality of life (AQLQ)

WMD of follow‐up 27.4 weeks

Mean AQLQ score was 5

Mean score with adherence education was 0.01 better (0.20 worse to 0.23 better)

734
(6 RCTs)

⊕⊕⊕⊝
MODERATEa,e

Higher score indicates better QOL. Scale 1 to 7. MCID 0.5

*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)

ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; CI: confidence interval; ED: emergency department; GP: general practitioner; MCID: minimal clinically important difference; OCS: oral corticosteroid; OR: odds ratio; QOL: quality of life; RCT: randomised controlled trial; WMD: weighted mean duration

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to the estimate of effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

aDowngraded once primarily owing to risk of bias from open‐label trials and some concerns regarding attrition bias, selective reporting and selection bias (‐1 risk of bias)

bDowngraded once owing to inconsistency between study results (‐1 inconsistency)

cFunnel plot examined; no clear evidence of publication bias (no downgrade for publication bias)

dConfidence intervals include no difference and/or potential important harm or benefit of the intervention (‐1 imprecision)

eConfidence intervals fall within the established MCID for this scale (no downgrade for imprecision)

fStudies contributing to this analysis reported different types of unscheduled visits and some recorded visits for any cause rather than asthma alone (‐1 indirectness)

gUnclear how absenteeism was defined or reported, and different participants may have different thresholds for missing work or school. One study was conducted in children and the other in adults. Combined, this makes the outcome hard to interpret

Figuras y tablas -
Summary of findings for the main comparison. Adherence education compared with controls for asthma
Summary of findings 2. Electronic trackers or reminders (± feedback) compared with controls for asthma

Electronic trackers or reminders (±feedback) compared with controls for asthma

Patient or population: asthma
Setting: community
Intervention: electronic trackers or reminders (± feedback)
Comparison: control group

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with controls

Risk with electronic trackers or reminders (± feedback)

% Adherence

WMD of follow‐up 47.6 weeks

Objective measures only

Mean adherence in the control group was 53.27%

Mean adherence was 19.86% higher (14.47 higher to 25.26 higher)

555

(6 RCTs)

⊕⊕⊕⊝
MODERATEa

Only studies in which adherence was measured with an electronic monitor

All measures

Mean adherence in the control group was 56.06%

Mean adherence with trackers was 18.41% higher (11.82 higher to 25.00 higher)

762

(8 RCTs)

⊕⊕⊝⊝
LOWa,b

Exacerbations requiring OCS

(people with at least 1)

WMD of follow‐up 48.6 weeks

218 per 1000

169 per 1000
(94 to 280)

OR 0.72
(0.37 to 1.39)

3063
(4 RCTs)

⊕⊝⊝⊝
VERY LOWa,b,c

Asthma control (ACQ)

WMD of follow‐up 43.0 weeks

Mean ACQ score in the control group was 0.89

Mean score with trackers or reminders was 0.24 better (0.29 worse to 0.78 better)

109
(2 RCTs)

⊕⊕⊝⊝
LOWa,c

Lower score indicates better control. Scale 0 to 6. MCID 0.5

Asthma control (ACT)

WMD of follow‐up 34.0 weeks

Mean ACT score in the control group was 20.04

Mean score with trackers or reminders was 0.74 better (0.20 worse to 1.69 better)

596
(4 RCTs)

⊕⊕⊝⊝
LOWa,b,d

Higher score indicates better control. Scale 5 to 25. MCID 3

Unscheduled healthcare visits to a healthcare provider (ED)

WMD of follow‐up 50.0 weeks

84 per 1000

95 per 1000
(75 to 119)

OR 1.14
(0.88 to 1.47)

2918
(2 RCTs)

⊕⊕⊕⊝
MODERATEc

Two studies (n = 2865) also reported hospitalisations. OR 0.97 (0.53 to 1.78)

Absenteeism

(people with at least 1 absence)

Follow‐up 26 weeks

327 per 1000

409 per 1000
(285 to 546)

OR 1.42
(0.82 to 2.47)

220
(1 RCT)

⊕⊕⊝⊝
LOWc,e

Quality of life (AQLQ)

WMD of follow‐up 36.8 weeks

Mean AQLQ score in the control group was 5.15

Mean score with trackers or reminders was 0.03 worse (0.13 better to 0.20 worse)

369
(4 RCTs)

⊕⊕⊕⊝
MODERATEa,d

Higher score indicated better QOL. Scale 1 to 7. MCID 0.5

*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; CI: confidence interval; ED: emergency department; MCID: minimal clinically important difference; OCS: oral corticosteroid; OR: odds ratio; QOL: quality of life; RCT: randomised controlled trial; WMD: weighted mean duration

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to the estimate of effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

aDowngraded once primarily owing to risk of bias from open‐label trials and some concerns regarding attrition bias, selective reporting and selection bias (‐1 risk of bias)

bDowngraded once for inconsistency between study results (‐1 inconsistency)

cConfidence intervals include no difference and potential important harm and benefit of the intervention (‐1 imprecision)

dConfidence intervals fall within the MCID for this scale (no downgrade for imprecision)

eDowngraded once owing to risk of performance and detection bias (‐1 risk of bias)

Figuras y tablas -
Summary of findings 2. Electronic trackers or reminders (± feedback) compared with controls for asthma
Summary of findings 3. Simplified compared with usual regimens for asthma

Simplified compared with usual regimens for asthma

Patient or population: asthma
Setting: community
Intervention: simplified regimens
Comparison: usual regimens

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with usual regimens

Risk with simplified regimens

% Adherence (objective measures)

WMD of follow‐up 12.9 weeks

Mean adherence in the control group was 86.73%

Mean adherence with simplified regimens was 4.02% higher
(1.88 higher to 6.16 higher)

1310
(3 RCTs)

⊕⊕⊕⊝
MODERATEa

Only studies in which adherence was measured with an electronic monitor

Exacerbations requiring OCS

People with 1 or more

Follow‐up 12 weeks

125 per 1000

250 per 1000
(24 to 823)

OR 2.33
(0.17 to 32.58)

16
(1 RCT)

⊕⊕⊝⊝
LOWb

Asthma control (ACQ)

Follow‐up 24 weeks

Mean ACQ score in the control group was 0.89

Mean score with simplified regimens was 0.03 better (0.34 better to 0.28 worse)

103
(1 RCT)

⊕⊕⊕⊝
MODERATEc

Lower score indicates better control. Scale 0 to 6. MCID 0.5

Unscheduled visits

Follow‐up 12 weeks

63 per 1000

72 per 1000
(46 to 113)

OR 1.17
(0.72 to 1.90)

1037
(1 RCT)

⊕⊕⊝⊝
LOWa,d

Absence from work/school

Follow‐up 12 weeks

19 per 1000

18 per 1000
(7 to 43)

OR 0.93
(0.37 to 2.30)

1037
(1 RCT)

⊕⊕⊝⊝
LOWa,d

Change in quality of life (ITG‐ASF)

Follow‐up 12 weeks

Mean change in quality of life in the control group was 14

Mean change with simplified regimens was 6 points better
(0.76 worse to 12.76 better)

1037
(1 RCT)

⊕⊕⊝⊝
LOWa,e

Higher score indicates better QOL. Range 0 to 100. MCID not known

All adverse events

Follow‐up 12 weeks

175 per 1000

139 per 1000
(106 to 181)

OR 0.76
(0.56 to 1.04)

1233
(1 RCT)

⊕⊕⊝⊝
LOWa,f

*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
ACQ: Asthma Control Questionnaire; CI: confidence interval; ITG‐ASF: Integrated Therapeutics Group ‐ Asthma Short Form; MCID: minimal clinically important difference; OCS: oral corticosteroid; OR: odds ratio; QOL: quality of life; RCT: randomised controlled trial; WMD: weighted mean duration

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to the estimate of effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

aDowngraded once primarily owing to lack of blinding and some concerns regarding attrition bias, selective reporting and selection bias (‐1 risk of bias)

bOne very small trial resulting in very wide confidence intervals (‐2 imprecision)

cAlthough confidence intervals fall within the MCID, only one study contributed to this outcome (‐1 imprecision)

dConfidence intervals include both important potential harm and benefit of the intervention (‐1 imprecision)

eConfidence intervals do not exclude no difference (‐1 imprecision)

fConfidence intervals range from no difference to an important benefit of simplified regimens (‐1 imprecision)

Figuras y tablas -
Summary of findings 3. Simplified compared with usual regimens for asthma
Summary of findings 4. School‐based ICS therapy compared with home therapy for asthma

School‐based ICS therapy compared with home therapy for asthma

Patient or population: children with asthma

Settings: school

Intervention: ICS given at school

Comparison: ICS given at home

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

School‐based ICS therapy

Unscheduled visits

1 or more hospitalisations for any cause

WMD of follow‐up 35.8 weeks

49 per 1000

29 per 1000
(8 to 96)

OR 0.58 (0.16 to 2.05)

279
(2 RCTs)

⊕⊕⊝⊝
LOWa,b

Quality of life (PACQLQ)

1 to 7; higher is better

WMD of follow‐up 35.8 weeks

Mean PAQLQ score in the control group was 6.31

Mean score in the intervention groups was
0.25 higher (0.01 to 0.49 higher)

279
(2 RCTs)

⊕⊕⊕⊝

MODERATEa

Adverse events

Follow‐up 30 weeks

No events observed in either arm

99

(1 RCT)

Not graded

*The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (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)
CI: confidence interval; ICS: inhaled corticosteroid; OR: odds ratio; PAQLQ: Paediatric Asthma Quality of Life Questionnaire; RCT: randomised controlled trial; WMD: weighted mean difference

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

No data could be meta‐analysed for adherence, exacerbations requiring OCS, asthma control or absenteeism. Some data are presented narratively in the review

aBoth contributing studies considered at high risk for performance and detection bias

bConfidence intervals include both potential harm and benefit of the intervention

Figuras y tablas -
Summary of findings 4. School‐based ICS therapy compared with home therapy for asthma
Table 1. Comparison 1 study characteristics: adherence education

Study ID ("first received" date for clinical trials registries)

Total n

Duration of intervention/follow‐up

Age

Country

Intervention

Control

Adherence measure

Outcomes

NCT00115323

(2005)

333

13/26 weeks

Adults

USA

Problem‐solving intervention

Asthma education

Electronic inhaler monitor

Adherence, AQLQ, ACQ, LFTs, hospitalisation,

ED visits, participant satisfaction

Bender 2010

50

10 weeks

Adults

USA

Interactive voice response intervention

Usual care

Electronic inhaler monitor or canister weight

Adherence, AQLQ, ACT, Beliefs about

Medication Questionnaire

NCT00958932

(2009)

1187

2 years

Children

USA

Telephone speech recognition intervention

Usual care

Total ICS supplied/total prescribed

Adherence, beta‐agonist use, OCS use, primary care, ED and out of hours visits, hospitalisations, participant satisfaction

Chatkin 2006

271

13 weeks

Adolescents and adults

Brazil

Telephone counselling

Ususal care

"Number of inhalations recorded on the disks"

Adherence

NCT00149487

(2005)

141

17 weeks/1 year

Children

USA

Problem‐solving intervention

Family‐based intervention

Electronic inhaler monitor

Adherence, symptoms, use of healthcare services, reliever medication use

NCT00166582

(2009)

55

2 months

Children

USA

Team work intervention

Asthma education

Electronic inhaler monitor

Adherence, Parent‐Adolescent Conflict Questionnaire, Functional Severity Index, LFTs, Consumer Satisfaction Survey

Foster 2014

60 GPs, 143 patients

6 months

Adolescents and adults

Australia

Personalised adherence discussion (PAD)

PAD + inhaler reminder feedback (IRF)

Usual care

Electronic inhaler monitor

ACT, AQLQ, Hospital Anxiety and Depression Scale, Medication Adherence Report Scale, LFTs, exacerbations

Gallefoss 1999

78

1 year

Adults

Norway

Asthma education

Usual care

Prescribed doses/dispensed doses

Adherence, GP visits, absenteeism, days in hospital

NCT01064869

(2010)

20

12 weeks/1 year

Not reported, but mean age suggests adults

Northern Ireland

Nurse‐led psychoeducation

Ususal care (difficult asthma service)

Percent of prescriptions refilled

Adherence, OCS, beta‐agonist use, hospital admissions, LFTs, ACQ, AQLQ, Hospital Anxiety and Despression Scale

ADERE PEDIATRIC 1

(2008)

298

90 weeks

Children

Brazil

Telephone follow‐up intervention

Usual care

Percentage of actual doses/number expected

Adherence, disease control, quality of life (SF‐36)

Hart 2002

83

13 weeks

Children

UK

Asthma education

Usual care

Electronic inhaler monitor

Adherence, beliefs and anxieties about adherence

NCT00516633

(2007)

60

26 weeks/78 weeks

Children

Sweden

Group discussion plus basic education

Basic education

Diaries and canister weight

Adherence, views on adherence, days hospitalised, ED visits, exacerbations

Kamps 2008

15

6 weeks/52 weeks

Children

USA

Specific adherence improvement strategies (education, monitoring, etc.)

Usual care plus education

Electronic inhaler monitor

Adherence, LFTs, PedsQL, healthcare costs

NCT01132430

(2010)

54

6 weeks/52 weeks

Adults

Canada

Motivational interviewing

Usual care

Prescribed treatment days/number of days

Adherence, asthma control, quality of life, asthma‐related self‐efficacy

Mehuys 2008

201

6 months

Adults

Belgium

Adherence education

Usual care

Prescription refill rates, self‐reporting

ACT, diary card, rescue medication use, ED visits, hospitalisations, AQLQ, Knowledge of Asthma and Asthma Medicine Questionnaire, inhalation technique

NCT01169883

(2010)

68

10 weeks

Adolescents

USA

Adherence messaging and group sessions

"Attention control"

Electronic inhaler monitor

Adherence, asthma knowledge, ICS knowledge, ICS self‐efficacy, social support, exacerbations

NCT02413528

(2015)

12

12 weeks

Adolescents

USA

Adherence monitoring and incentivisation via app and sensor

Usual care

Electronic inhaler monitor

Adherence, ACT

NB: study terminated

Onyirimba 2003

30

10 weeks

Adults

USA

Adherence monitoring and education

Monitoring without feedback

Electronic inhaler monitor

Adherence, rescue medication use, AQLQ, LFTs

NCT00233181

(2005)

250

78 weeks

Children

USA

Adherence education

Usual care

Prescription refill rates, self‐reporting

Adherence, symptoms, night‐time awakenings, ED visits, hospitalisation, OCS courses

Ulrik 2009

274

12 weeks

Adults

Denmark and Switzerland

Adherence education and study medication

Study medication alone

Dose counting in returned investigational product

Adherence, asthma control, LFTs, symptoms, rescue medication use, night‐time awakenings, adverse events, AQLQ, asthma severity, adverse events, vital signs

NCT00414817

(2006)

14,064 (6903 previous ICS users)

78 weeks

Adults

USA

Telephone interactive voice recognition intervention

Usual care

Pharmacy‐based adherence measures

Adherence, use of healthcare services, economic evaluation

ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; ED: emergency department; GP: general practitioner; ICS: inhaled corticosteroid; IRF: inhaler reminder feedback; LFTs: lung function tests; OCS: oral corticosteroid; PAD: personalised adherence discussion; PedsQL: Paediatric Quality of Life Inventory; SF‐36: Short‐Form Health Survey

Figuras y tablas -
Table 1. Comparison 1 study characteristics: adherence education
Table 2. Comparison 2 study characteristics: electronic trackers or reminders

Study ID

Total n

Duration of intervention/follow‐up

Age

Country

Intervention

Control

Adherence measure

Outcomes

Black 2008

40

2 months

Children

New Zealand

Inhaler alarm

Usual care

Electronic inhaler monitor

Adherence, AQLQ, LFTs, beta‐agonist use

ACTRN12607000489493

(2007)

26

4 months

Children

Australia

Adherence feedback during consultations

Usual care

Electronic inhaler monitor

Adherence, symptoms, LFTs

Chan 2015

220

6 months

Children

New Zealand

Audiovisual inhaler reminder

Usual care

Electronic inhaler monitor

Adherence, school/work absences, ACT, Asthma Morbidity Score, exacerbations, unscheduled visits, beta‐agonist use, LFTs

Charles 2007

110

24 weeks

Adolescents and adults

New Zealand

Audiovisual inhaler reminder

Usual care

Electronic inhaler monitor

Adherence, ACQ, LFTs

Foster 2014

60 GPs, 143 patients

6 months

Adolescents and adults

Australia

Inhaler reminder and feedback (IRF)

Usual care

Electronic inhaler monitor

ACT, AQLQ, Hospital Anxiety and Depression Scale, Medication Adherence Report Scale, LFTs, exacerbations

NCT01714141

(2012)

49

13 weeks

Young adults

USA

Computer sessions and tailored text reminders

Asthma education

Self‐reported missed doses

Adherence, ACT, LFTs, participant satisfaction

NCT02451709

(2015)

90

1 year

Children

UK

Adherence monitoring with feedback

Adherence monitoring but no feedback

Electronic inhaler monitor

"Clinical outcomes", adherence, LFTs, exacerbations

NCT00233181

(2005)

250

78 weeks

Children

USA

Adherence monitoring and education

Adherence education

Prescription refill rates, self‐reporting

Adherence, symptoms, night‐time awakenings, ED visits, hospitalisation, OCS courses

Strandbygaard 2010

26

12 weeks

Adults

Denmark

SMS (text message) adherence reminders

Usual care

"Dose‐count" on the Seretide was diskus

Adherence, change in FeNO, LFTs, airway responsiveness

Vasbinder 2015 E‐MATIC

219

52 weeks

Children

The Netherlands

SMS (text message) adherence reminders

Usual care

Electronic inhaler monitor

Adherence, ACT, exacerbations, use of healthcare services, AQLQ, school/work absence, acceptance of e‐monitoring, economic evaluation

NCT00459368

(2007)

2698 (34 clusters)

52 weeks

Children and adults

USA

Adherence education with adherence feedback

Adherence education alone

Electronic prescribing data/refill rate

Adherence, ED visits, hospitalisation, OCS use

ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; ED: emergency department; FeNO: fractional exhaled nitric oxide; ICS: inhaled corticosteroid; LFTs: lung function tests; OCS: oral corticosteroid

Figuras y tablas -
Table 2. Comparison 2 study characteristics: electronic trackers or reminders
Table 3. Comparison 3 study characteristics: simplified regimens

Study ID

Total n

Duration of intervention/follow‐up

Age

Country

Intervention

Control

Adherence measure

Outcomes

Bosley 1994

102

12 weeks

Adults

UK

Combined inhaler

Separate inhalers

Electronic inhaler monitor

Adherence, LFTs

Mann 1992

16

6 weeks/12 weeks

Adults

USA

Twice‐daily dosing

Four‐times‐daily dosing

Electronic inhaler monitor

Adherence, LFTs, symptoms

ACTRN12606000508572

(2007)

111

24 weeks

Children

New Zealand

Combined inhaler

Separate inhalers

Electronic inhaler monitor

Adherence, LFTs, ACQ, OCS, unscheduled visits

Price 2010

1233

12 weeks

Adolescents and adults

UK

Once‐daily ICS

Twice‐daily ICS

"Device counter number"

Adherence, physician assessment of response, quality of life, use of healthcare services, days of school/work missed, adverse events, worsening asthma

ACQ: Asthma Control Questionnaire; ICS: inhaled corticosteroid; LFTs: lung function tests; OCS: oral corticosteroid

Figuras y tablas -
Table 3. Comparison 3 study characteristics: simplified regimens
Table 4. Comparison 4 study characteristics: school‐based ICS therapy

Study ID

Total n

Duration of intervention/follow‐up

Age

Country

Intervention

Control

Adherence measure

Outcomes

Gerald 2009

290

65 weeks

Children

USA

Supervised ICS therapy at school

Usual care

N/A

Episodes of poor asthma control, school absences, rescue medication use at school

Halterman 2004

184

9 weeks

Children

USA

Supervised ICS therapy at school

Usual care

N/A

Symptom‐free days, daytime and night‐time symptoms, rescue medication use, school absences

NCT01175434

(2010)

100

6 to 8 months

Children

USA

Supervised ICS therapy at school

Usual care

N/A

Feasibility, symptom‐free days, numbers of days and nights with symptoms, activity limitation, rescue medication use, school absenteeism, parent sleep interruption, change in family plans due to the child’s asthma, PAQLQ, utilisation of healthcare services, FeNO

FeNO: fractional exhaled nitric oxide; ICS: inhaled corticosteroid; PAQLQ: Pediatric Asthma Quality of Life Questionnaire

Figuras y tablas -
Table 4. Comparison 4 study characteristics: school‐based ICS therapy
Comparison 1. Adherence education versus controls

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 % Adherence (objective measures) Show forest plot

5

280

Mean Difference (IV, Random, 95% CI)

20.13 [7.52, 32.74]

1.1 Complex

4

230

Mean Difference (IV, Random, 95% CI)

21.55 [4.71, 38.39]

1.2 Simple education

1

50

Mean Difference (IV, Random, 95% CI)

15.40 [5.98, 24.82]

2 % Adherence (all measures) Show forest plot

10

1693

Mean Difference (IV, Random, 95% CI)

11.59 [3.72, 19.46]

2.1 Complex

8

744

Mean Difference (IV, Random, 95% CI)

12.21 [1.26, 23.17]

2.2 Simple education

2

949

Mean Difference (IV, Random, 95% CI)

10.60 [5.17, 16.03]

3 > 85% adherence Show forest plot

1

271

Odds Ratio (M‐H, Random, 95% CI)

2.68 [1.61, 4.46]

4 Exacerbations requiring OCS (people with 1 or more) Show forest plot

3

349

Odds Ratio (M‐H, Random, 95% CI)

1.82 [0.99, 3.36]

5 Asthma control Show forest plot

6

Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 ACQ

4

455

Mean Difference (IV, Random, 95% CI)

‐0.03 [‐0.49, 0.43]

5.2 ACT

3

333

Mean Difference (IV, Random, 95% CI)

0.30 [‐0.82, 1.43]

6 Unsheduled visits to a healthcare provider (people with 1 or more) Show forest plot

4

688

Odds Ratio (M‐H, Random, 95% CI)

0.48 [0.19, 1.19]

6.1 Hospital

1

250

Odds Ratio (M‐H, Random, 95% CI)

1.23 [0.56, 2.70]

6.2 ED

2

367

Odds Ratio (M‐H, Random, 95% CI)

0.23 [0.06, 0.83]

6.3 GP

1

71

Odds Ratio (M‐H, Random, 95% CI)

0.20 [0.07, 0.54]

7 Quality of life (AQLQ) Show forest plot

6

734

Mean Difference (IV, Random, 95% CI)

0.01 [‐0.20, 0.23]

Figuras y tablas -
Comparison 1. Adherence education versus controls
Comparison 2. Electronic trackers or reminders (± feedback) versus controls

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 % Adherence (objective measures) Show forest plot

6

555

Mean Difference (IV, Random, 95% CI)

19.86 [14.47, 25.26]

1.1 Reminders/trackers

3

321

Mean Difference (IV, Random, 95% CI)

16.29 [9.53, 23.04]

1.2 With feedback

3

234

Mean Difference (IV, Random, 95% CI)

24.98 [17.53, 32.44]

2 % Adherence (all measures) Show forest plot

8

762

Mean Difference (IV, Random, 95% CI)

18.41 [11.82, 25.00]

2.1 Reminders/trackers

4

361

Mean Difference (IV, Random, 95% CI)

16.92 [10.82, 23.02]

2.2 With feedback

4

401

Mean Difference (IV, Random, 95% CI)

20.06 [7.27, 32.85]

3 Exacerbations requiring OCS (people with at least 1) Show forest plot

4

3063

Odds Ratio (M‐H, Random, 95% CI)

0.72 [0.37, 1.39]

4 Asthma control Show forest plot

6

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 ACQ

2

109

Mean Difference (IV, Random, 95% CI)

0.24 [‐0.29, 0.78]

4.2 ACT

4

596

Mean Difference (IV, Random, 95% CI)

0.74 [‐0.20, 1.69]

5 Unscheduled visits to a healthcare provider Show forest plot

3

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only

5.1 ED

2

2918

Odds Ratio (M‐H, Random, 95% CI)

1.14 [0.88, 1.47]

5.2 Hospital

2

2865

Odds Ratio (M‐H, Random, 95% CI)

0.97 [0.53, 1.78]

6 Unscheduled visits to a healthcare provider Show forest plot

1

Rate Ratio (Random, 95% CI)

Totals not selected

6.1 GP/ED visits

1

Rate Ratio (Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Hospitalisations

1

Rate Ratio (Random, 95% CI)

0.0 [0.0, 0.0]

7 Absenteeism Show forest plot

1

Odds Ratio (M‐H, Random, 95% CI)

Totals not selected

8 Absenteeism Show forest plot

1

Rate Ratio (Fixed, 95% CI)

Subtotals only

9 Quality of life (AQLQ) Show forest plot

4

369

Mean Difference (IV, Random, 95% CI)

‐0.03 [‐0.20, 0.13]

Figuras y tablas -
Comparison 2. Electronic trackers or reminders (± feedback) versus controls
Comparison 3. Simplified versus usual regimens

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 % Adherence Show forest plot

3

1310

Mean Difference (IV, Random, 95% CI)

4.02 [1.88, 6.16]

2 Exacerbations requiring OCS Show forest plot

1

Odds Ratio (M‐H, Random, 95% CI)

Totals not selected

3 Asthma control (ACQ) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4 Unscheduled visits Show forest plot

1

Odds Ratio (M‐H, Random, 95% CI)

Totals not selected

5 Absence from work/school Show forest plot

1

Odds Ratio (M‐H, Random, 95% CI)

Totals not selected

6 Quality of life (ITG‐ASF % change from baseline) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

7 All adverse events Show forest plot

1

Odds Ratio (M‐H, Random, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 3. Simplified versus usual regimens
Comparison 4. School‐based ICS therapy versus controls

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Unscheduled visits (1 or more hospitalisations for any cause) Show forest plot

2

279

Odds Ratio (M‐H, Random, 95% CI)

0.58 [0.16, 2.05]

2 Quality of life (PAQLQ) Show forest plot

2

279

Mean Difference (IV, Random, 95% CI)

0.25 [0.01, 0.49]

Figuras y tablas -
Comparison 4. School‐based ICS therapy versus controls
Comparison 5. Subgroup analyses for % adherence

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Comparison 1. Children vs adults Show forest plot

10

1693

Mean Difference (IV, Random, 95% CI)

11.59 [3.72, 19.46]

1.1 Children

4

1241

Mean Difference (IV, Random, 95% CI)

8.01 [‐4.77, 20.79]

1.2 Adults/adolescents and adults

6

452

Mean Difference (IV, Random, 95% CI)

14.43 [5.49, 23.36]

2 Comparison 2. Complex vs simple interventions Show forest plot

6

555

Mean Difference (IV, Random, 95% CI)

19.86 [14.47, 25.26]

2.1 Complex

3

234

Mean Difference (IV, Random, 95% CI)

24.98 [17.53, 32.44]

2.2 Simple

3

321

Mean Difference (IV, Random, 95% CI)

16.29 [9.53, 23.04]

3 Comparison 2. Children vs adults Show forest plot

6

555

Mean Difference (IV, Random, 95% CI)

19.86 [14.47, 25.26]

3.1 Children

3

314

Mean Difference (IV, Random, 95% CI)

17.29 [8.32, 26.26]

3.2 Adults/adolescents and adults

3

241

Mean Difference (IV, Random, 95% CI)

22.84 [16.66, 29.02]

Figuras y tablas -
Comparison 5. Subgroup analyses for % adherence