Written action plans for asthma in children (Review) The Cochrane Library

Transcription

Written action plans for asthma in children (Review)
Bhogal SK, Zemek RL, Ducharme F
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2009, Issue 1
http://www.thecochranelibrary.com
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACKNOWLEDGEMENTS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Peak flow-based self-management plan versus Symptom-based self-management plan, Outcome
1 Number of patients with at least one acute care visits for asthma. . . . . . . . . . . . . . . .
2 Number of acute case visits per number of times STEP 2 was used (# visits/#STEP 2 taken). . . . . . .
3 Number of patients with exacerbations requiring at least one course of systemic steroids standardized over 1 yr.
4 Number of patients requiring hospital admission. . . . . . . . . . . . . . . . . . . . . .
5 Change in the number of symptomatic days per week. . . . . . . . . . . . . . . . . . . .
6 Number of symptomatic days per week. . . . . . . . . . . . . . . . . . . . . . . . .
7 Number of patients who missed school. . . . . . . . . . . . . . . . . . . . . . . . .
8 Change in baseline in % predicted FEV1 value during 3-months of intervention. . . . . . . . . . .
9 Average % predicted FEV1 value during 3-months of intervention. . . . . . . . . . . . . . . .
Analysis 1.10. Comparison 1 Peak flow-based self-management plan versus Symptom-based self-management plan,
Outcome 10 Change in symptom score at 3 months. . . . . . . . . . . . . . . . . . . . .
Outcome 11 Symptom score at 3-months post-intervention. . . . . . . . . . . . . . . . . . .
Outcome 12 Symptom score at 1-year post-intervention. . . . . . . . . . . . . . . . . . . .
Outcome 13 Change in CHILD quality of life at 3-months. . . . . . . . . . . . . . . . . . .
Outcome 14 Change in CHILD quality of life at 1-year. . . . . . . . . . . . . . . . . . . .
Outcome 15 Change in PARENT quality of life at 3-months. . . . . . . . . . . . . . . . . .
Outcome 16 Change in PARENT quality of life at 1-year. . . . . . . . . . . . . . . . . . .
Outcome 17 Withdrawals for any reason. . . . . . . . . . . . . . . . . . . . . . . . .
Outcome 18 Number of CHILDREN who intend to continue using monitoring strategy. . . . . . . .
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Outcome 19 Number of PARENTS who intend to continue use of monitoring strategy. . . . . . . . .
Analysis 2.1. Comparison 2 Sub-group analysis of primary outcome: Number of patients with at least one acute care visit
for asthma, Outcome 1 Number of steps. . . . . . . . . . . . . . . . . . . . . . . . .
for asthma, Outcome 2 Colour.
. . . . . . . . . . . . . . . . . . . . . . . . . . .
for asthma, Outcome 3 Intensity of PEF monitoring. . . . . . . . . . . . . . . . . . . . .
for asthma, Outcome 4 100% anti-inflammatory medication. . . . . . . . . . . . . . . . . .
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
INDEX TERMS
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[Intervention Review]
Written action plans for asthma in children
Sanjit K. Bhogal2 , Roger L Zemek3 , Francine Ducharme1
1 Direction de la Recherche/ Research Centre, CHU Sainte-Justine,
Montreal, Canada. 2 Department of Epidemiology and Biostatistics,
McGill University, Montreal , Canada. 3 Pediatric Emergency Medicine, Montreal Childern’s Hospital, McGill University, Montreal ,
Canada
Contact address: Francine Ducharme, Direction de la Recherche/ Research Centre, CHU Sainte-Justine, 3175 Cote Sainte-Catherine,
Montreal, Québec, H3T 1C5, Canada. [email protected].
Editorial group: Cochrane Airways Group.
Publication status and date: Edited (no change to conclusions), published in Issue 1, 2009.
Review content assessed as up-to-date: 23 March 2006.
Citation: Bhogal SK, Zemek RL, Ducharme F. Written action plans for asthma in children. Cochrane Database of Systematic Reviews
2006, Issue 3. Art. No.: CD005306. DOI: 10.1002/14651858.CD005306.pub2.
ABSTRACT
Background
While all asthma consensus statements recommend the use of written action plan (WAP) as a central part of asthma management,
a recent systematic review of randomised trials highlighted the paucity of trials where the only difference between groups was the
provision or not of a written action plan.
Objectives
The objectives of this review were firstly to evaluate the independent effect of providing versus not providing a written action plan in
children and adolescents with asthma, and secondly to compare the effect of different written action plans.
Search strategy
We searched the Cochrane Airways Group Specialised Register (November 2004), which is derived from searches of CENTRAL,
MEDLINE, EMBASE, CINAHL, as well as handsearched respiratory journals, and meeting abstracts. We also searched bibliographies
of included studies and identified review articles.
Selection criteria
Randomised controlled trials were included if they compared a written action plan with no written action plan, or different written
action plans with each other.
Data collection and analysis
Two authors independently selected the trials, assessed trial quality and extracted the data. Study authors were contacted for additional
information.
Main results
Four trials (three RCTs and one quasi-RCT) involving 355 children were included. Children using symptom-based WAPs had lower
risk of exacerbations which required an acute care visit (N = 5; RR 0.73; 95% CI 0.55 to 0.99). The number needed to treat to prevent
one acute care visit was 9 (95% CI 5 to 138). Symptom monitoring was preferred over peak flow monitoring by children (N = 2; RR
1.21; 95% CI 1.00 to 1.46), but parents showed no preference (N = 2; RR 0.96; 95% CI 0.18 to 2.11). Children assigned to peak
flow-based action plans reduced by 1/2 day the number of symptomatic days per week (N = 2; mean difference: 0.45 days/week; 95%
1
CI 0.04 to 0.26). There were no significant group differences in the rate of exacerbation requiring oral steroids or admission, school
absenteeism, lung function, symptom score, quality of life, and withdrawals.
Authors’ conclusions
The evidence suggests that symptom-based WAP are superior to peak flow WAP for preventing acute care visits although there is
insufficient data to firmly conclude whether the observed superiority is conferred by greater adherence to the monitoring strategy,
earlier identification of onset of deteriorations, higher threshold for presentation to acute care settings, or the specific treatment
recommendations.
PLAIN LANGUAGE SUMMARY
This review examines the net impact of providing written action plans to children with asthma and their parents
We did not find any trial examining the benefit of providing versus not providing a written action plan to children with asthma.
Four clinical trials with 355 children were identified which compared the effect of symptom-based versus to peak flow written action
plans when all other co-interventions were similar. Children assigned to a symptom-based plan less frequently required an acute care
visit for asthma compared to those who received a peak flow based plan. Most other outcomes were similar with the exception of more
children intending to continue using the symptom-based compared to the peak-flow based written action plan.
BACKGROUND
Asthma exacerbations are often viewed as discrete episodes of deterioration triggered by a virus, exercise, or allergen (Chan-Yeung
1996; Turner 1998a). However, in many cases, exacerbations occur on a background of chronic sub-optimal asthma control. Optimal daily asthma control results in less asthma lability (for example less frequent and less severe exacerbations) in response to
various triggers. Since all individuals diagnosed with asthma are
susceptible to asthma exacerbations, patients with asthma should
know how to prevent and manage these episodes (Gibson 2004).
The need for active participation on the part of the parent or
individual with asthma to prevent exacerbations has led to the
universal recommendation by national and international asthma
guidelines to provide written action plans (WAP), also termed
self-management action plans, for home management of asthma
(Asthma Handbook 2002; BTS 2005; Lemiere 2004; NAEPP;
von Mutius 2000). Such action plans consist of a written set of
instructions given to patients with asthma for the management of
chronic symptoms as well as for the prevention and management
of exacerbations.
A written action plan probably serves several functions. First, it
acts as a communication tool between the health care professional
and the patient. Next, it functions as a reminder to patients of
the treatment plan, including instructions for step-up and stepdown therapy in response to deterioration and improvement. It
is believed that a written action plan should be tailored to the
patient and the type and severity of asthma. It should specify which
medications should be used as maintenance therapy (when the
patient is well); when, how, for how long to modify medications in
case of deterioration; and when to access the medical system in the
event of worsening asthma. Individualisation is thus expected in
the choice and dosage of medication, type of inhalation device(s),
and personal indicators of deterioration.
In adults with asthma, self-management education (including regular reviews and a written action plan) clearly leads to improved
health outcomes (Gibson 2003). Several paediatric reviews have
examined the effectiveness of asthma education in children with
conflicting results. An earlier systemic review of randomised controlled trials was unable to document any consistent favourable
effect of self-management education in children (Bernard Bonnin
1995). A Cochrane review of controlled and randomised trials reported a favourable effect of asthma education (including, but not
limited to, a written action plan) on lung function, self-efficacy (
Wolf 2002), activities, and emergency department visits. The effect appeared stronger with more severe asthma and in studies using peak flow rather than symptom-based strategies.
2
Patients tend to have a positive perception regarding the use of
action plans, and found that actions plans were useful for the management of their asthma (Douglass 2002). Yet a written action plan
cannot be viewed in isolation. It is usually part of a multifaceted
intervention, including education sessions by a trained educator
(covering avoidance of triggers, recognition of signs of deterioration, and instructions for the prevention and management of
exacerbations), medical review, and prescription of medications.
While a recent review of randomised controlled trials suggested
some key elements for successful action plan in adults (i.e., 2 to
4 action points, recognition of deteriorations based on symptoms
or personal best peak expiratory flow (PEF), dose doubling of inhaled corticosteroids and/or self-initiation of oral corticosteroids
during exacerbations), the groups also differed by the presence (in
the written action plan group) or the absence (in the no written action plan group) of educational co-interventions (Gibson 2003).
A recent systematic review of randomised trials highlighted the
paucity of trials where the only difference between groups was the
provision or not of a written action plan (Lefevre 2002). The authors concluded that the application of written action plan may
be a waste of useful resources and may have been inappropriately
recommended as indicator of quality of care.
Therefore, there exists a need to confirm the efficacy of written
action plans in the paediatric population. The paediatric population has several characteristics that make this assessment particularly challenging. First, is the person targeted for application of a
written action plan (child or teenager-centred, parent-centred or
both) which likely varies not only with the child’s age, maturity,
but also with child rearing philosophy and specific family interaction. Second, is the use of proxy (e.g. parents or legal guardians) for
the recognition of symptoms, particularly for younger children.
Parents and child perception of symptoms and quality life are not
always in agreement and the discrepancy increases with child’s age
(Burr 1999;Braun-Fahrlander 89; Guyatt 1997; Renzoni 1999).
Other possibly important factors include the (1) complexity, attractiveness, clarity, and reading level of the written action plan
particularly when the child is the person targeted, (2) adherence to
the treatment dictated by the written action plan, (3) parent’s acceptance of the diagnosis and comfort with treatment, (4) parental
worry about safety of chronic administration of medication, (5)
type of asthma (episodic versus persistent), and (6) the limited
effective treatment strategies for the self-management of exacerbations in childhood asthma. Indeed, in paediatric, the only intervention consistently proven effective for preventing exacerbation
is the use of daily anti-inflammatory therapy (rather than episodic
treatment during exacerbations), with no apparent benefit from
increasing the dose of anti-inflammatory therapy (Volovitz 2001)
and conflicting benefit (and unknown safety) of self-initiation
of oral steroids (Garrett 1998; Horowitz 1994; Oommen 2003;
Steven 2002) at onset of exacerbations.
Clearly asthma education is beneficial (Wolf 2002) but what is
the independent contribution of the provision of a written action
plan to this effect and what elements of a written action plan are
most effective?
OBJECTIVES
The objective of this review is to evaluate the independent effect of
providing a written action plan vs. not providing a written action
plan in children and adolescents with asthma. More specifically
we wish to quantify any beneficial effect on asthma morbidity associated with the provision of a written action plan. We also wish
examine the efficacy of different types of action plans to identify
the key elements of a written action plan that may be associated
with greater effectiveness in terms of format, instructions for daily
treatment, instructions for step-up therapy, other ancillary instructions, and specific symptom versus peak-flow based instructions
as to when to seek emergency help.
METHODS
Criteria for considering studies for this review
Types of studies
Randomised (or quasi-randomised) controlled trials with a parallel-group design were included, irrespective of blinding or the
presence of placebo.
Types of participants
Children aged 0 to 17 years inclusively in whom asthma was diagnosed according to standard ATS criteria of reversibility and response to inhaled beta-2 agonist and/or anti-inflammatory treatment. In children less than two years, an additional criterion consisted of three or more episodes of wheezing, in order to reasonably exclude bronchiolitis. All settings of recruitment (emergency
room, observation unit, in-patients, out-patients, general practice
and home) were included as long as self-management plan at home
was examined. Trials including adults and children were included
if subgroup analyses on children and adolescents were available.
Types of interventions
The intervention must have been a written action plan for asthma
management. The control group must have been assigned to receive no written action plan or another type of written action plan.
Studies were included if they compared:
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1. written action plan (Intervention) with no written action plan
(Control);
2. written action plan (Intervention A) with a different written
action plan (Intervention B).
All other medical and non-medical co-interventions were required
to be similar between groups in order to determine the net benefit of a written action plan. No minimum duration of time was
required.
We defined a written action plan as written set of instructions
given to patients/parents that:
1. was intended to stay in their hands until the next visit (thus
excluding pharmacy prescriptions);
2. provided instructions for daily treatment;
3. provided instructions for initiation/step-up treatment in the
event of deterioration; and
4. provided information regarding when to seek urgent medical
consultation.
Of note, we expanded definition of an action plan suggested by the
Global Initiative for Asthma (GINA 2005) by adding the first two
criteria. We made explicit the first criterion, which was previously
implied. Second, we felt important that the WAP was structured
to allow the recording of effective recommendations. We added
the second criteria because in pediatrics, the evidence derived from
randomised controlled trials has identified maintenance inhaled
steroids as the single most effective way to decrease exacerbations
(Adams 1999; Adams 2005a; Adams 2005). Indeed, an increased
dose of inhaled steroids during exacerbations have not been shown
superior to just adding relief short-acting ß2-agonists in children
or adults. (FitzGerald 2004; Garrett 1998; Volovitz 2001).
Types of outcome measures
The primary outcome measure was the number of patients with an
asthma exacerbation requiring an unscheduled medical or emergency department visit, as indicative of failure of the written action plan.
Secondary outcome measures included: (1) measures reflecting the
severity of exacerbations including the rate of patients requiring
rescue oral steroids whether self-initiated as per the written action
plan and/or initiated by a physician and the proportion of patients requiring hospital admission; (2) measures reflecting chronic
asthma control such as change in asthma control score, change in
pulmonary function tests, days/nights with/without symptoms,
symptom scores, quality of life/functional status, and use of rescue
short-acting beta-2 agonist, days/night with/without rescue beta2 agonist, school absenteeism/days lost from usual activities, and
parent days lost from work/usual activities; (3) parent and patient
perception/satisfaction, adherence to maintenance and/or step-up
therapy; (4) changes in measures of inflammation such as expired
nitric oxide was also considered; (5) rates of adverse effects and
withdrawal rates.
Search methods for identification of studies
We identified trials using the Cochrane Airways Group Specialised
Register, which is derived from systematic searches of systematic
searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and CINAHL, and hand searching of respiratory journals
and meeting abstracts. All records in the Specialised Register coded
as ’asthma’ were searched using the following terms:
(educat* OR self-manag* OR “self manag*” OR “action plan*”
OR action-plan* OR self-care OR “self care” OR self-medicat*
OR “self medicat*” OR “management-plan” OR “management
plan” or “management program*”) AND (child* OR paediat* OR
pediat* OR infant* OR toddler* OR bab* OR young* OR school*
OR newborn* OR new-born* OR neo-nat* OR neonat* OR parent*)
Handsearched respiratory journals, and meeting abstracts were
surveyed using the same terms. We also searched bibliographies of
included studies and identified review articles.
We carried out the searches in November 2004 and we will update
these annually.
Data collection and analysis
Selection of trials
From the title, abstract or descriptors, two authors (SB and RZ)
independently reviewed the titles, abstracts and citation of all trials
identified by the literature search. Those appearing to address the
subject of a written action plan in the paediatric population were
selected for full text review to determine if they meet inclusion
criteria. Any discrepancies were resolved by consensus with the
involvement of a third author (FD).
Quality assessment
Two authors (SB and RZ) independently assessed the quality of
all studies included for review. Inter-rater reliability was measured
using the simple agreement and kappa-weighted statistics. Using
the Cochrane Collaboration approach to the assessment of allocation, all trials were graded using the following grades:
Grade A - Adequate allocation concealment
Grade B - Unclear allocation concealment
Grade C - Inadequate allocation concealment
Grade D - Allocation concealment not used
Due to the large weight given to blinding in the Jadad’s scale (
Moseley 2002) a design characteristic difficult to implement in
this field, we selected the Physiotherapy Evidence Database (PEDro) for the assessment of study methodology. This scale, developed by the Centre for Evidence-Based Physiotherapy (CEBP) (
Moseley 2002), includes 10 methodological criteria, each of which
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was scored 1 if present or 0 if absent. The PEDro scale recognizes
that while blinding is important, it is not always feasible. Accordingly, the PEDro scale assesses blinding at three different levels and
other important criteria such as concealed allocation, intention to
treat analysis and adequacy of follow up. Therefore, studies that
are unable to be double blinded due to the study question, but
that otherwise demonstrate high internal validity, are not unjustly
penalized. The maximum score a study can receive was 10. Scale
items consist of:
1. Participants were randomly allocated to groups (in a crossover
study, participants were randomly allocated to order in which treatments were received).
2. Allocation was concealed.
3. The groups were similar at baseline regarding the most important prognostic indicators.
4. There was blinding of all participants.
5. There was blinding of all therapists who administered the therapy.
6. There was blinding of all assessors who measured at least one
key outcome.
7. Measurement of the main outcome in more than 85% of the
participant randomised.
8. All participants for whom outcome measures were available
received the treatment or control condition as allocated or, where
this was not the case, data for at least one key outcome was analysed
by “intention to treat”.
9. The results of between-group statistical comparisons are reported for at least one key outcome.
10. The study provides both point measures and measures of variability for at least one key outcome.
The methodological quality of the studies were categorized as excellent (score 9 to 10), good (score 6 to 8), fair (score 4 to 5) and
poor (score 3 or less) according the levels of evidence outlined by
Foley 2003.
We only considered intention-to-treat analysis employed if the trial
explicitly stated than an intention-to-treat analysis was performed
or if the study experienced no dropouts or losses to follow up and
stated that patients were analysed according to the original group
assignment.
Blinding of assessors was considered adequate if the reader can be
satisfied that the apparent effect (or lack of effect) of the treatment
was not due to the assessor’s bias impinging on their measured
outcomes.
ductions and estimations from other data presented in the paper.
Statistical analysis
All trials were combined using RevMan Analyses, For dichotomous variables, we calculated individual and pooled statistics, as
Relative Risk (RR) with 95% confidence intervals (95% CI). For
continuous variables, individual and pooled statistics were calculated as mean differences (MD) or standardised mean differences
(SMD), as indicated, with 95% confidence intervals (95% CI).
Homogeneity of effect sizes between studies being pooled were
tested with the DerSimonian & Laird method, with P < 0.05 and
I2 = 25% (Higgins 2003) being used as the cut-off level for significance. If heterogeneity was suggested, we applied the DerSimonian & Laird random-effects model to the summary estimates.
Unless otherwise specified, fixed-effect model was reported, as it
is better equipped for detecting small effect sizes compared to the
random-effect methods (Fields 2001).
If two control-intervention comparisons used the same group
twice as comparator (for example a three-arm study had two intervention arms but only one control arm), the number of participants in the group used twice (in this instance the control group)
was halved to avoid over-representation. For event rate, the denominator was also halved in the control group.
Studies designed to test equivalence in treatment efficacy require
a different analytical approach to that used for trials in which the
hypothesis under test was that one treatment has greater efficacy
than its comparator. This was because small trials may favour the
conclusion that there was no difference between treatments, since
the confidence intervals for the two treatments were wide and
therefore more likely to include the line of no difference between
the two treatments. We assumed equivalence if the point estimate
and the 95% confidence limits of the relative risks were between
0.9 to 1.1.
Number Needed to Treat (NNT) was derived from the
pooled Odds Ratio using Visual Rx (an online calculator at
www.nntonline.net) (Cates 2002). NNT was calculated only for
the primary outcome.
Subgroup analysis
Irrespective of the presence or absence of heterogeneity, we performed the following subgroup analyses on the main outcome to
explore possible effect modifications:
Data extraction
Two authors (SB and RZ) independently extracted data for the
trials and entered into the Cochrane Collaboration software program, Review Manager, Version 4.2. We asked primary study authors to confirm the methodology and data extraction and asked
to provide additional information and clarification for the trial, as
needed. If necessary, we performed expansions of graphic repro-
Written action plan format
1. Targeted person (child, parent or both)
2. Simplicity (reading level)
3. Number of steps
4. Colour/graphics (street lights, sunshine, etc) associated with
steps
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5. Step recognition (symptoms, % predicted PEF, % best PEF)
6. Intensity of monitoring (daily versus only when symptomatic)
Written action plan instructions
7. Prescribed daily anti-inflammatory therapy (yes, no, inconsistent/not reported)
8. Recommended step-up therapy: (a) beta-2 agonist alone; (b)
beta-2 agonist and increased inhaled steroids; (c) beta-2 agonist,
and oral steroids; (d) beta-2 agonist with increased inhaled steroids
and oral steroids; (e) inconsistent/not reported.
Of note, the intensity of monitoring (daily or only when symptomatic) was added after publication of the protocol when included trials were reviewed, but before data extraction. This factor,
which had not been forecasted, served to stratify trials into daily
PF monitoring and/or PF monitoring only when symptomatic.
We performed sensitivity analyses to investigate the potential effect of: (1) methodological quality, (2) publication bias, and (3)
funding bias on the study results. Funnel plots were used to test
for the presence of possible publication bias (Egger 2001). The
fail-safe N test was used to assess the robustness of the results (
Gleser 1996).
We examined differences in the magnitude of effect attributable
to these subgroups with the residual Chi-squared test from the
Peto Odds Ratio (Deeks 2001). All estimates were reported with
their 95% confidence interval. The meta-analysis was performed
using RevMan Analyses (only available from RevMan 4.2 and later
versions).
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies.
Results of the search
The initial literature search identified 349 citations. Of these, 345
were excluded for the following reasons: (1) duplicate references
(N = 16); (2) not a randomised controlled trial (N = 57); (3) only
included an adult patient population (N = 48); (4) included both
adult and paediatric patient population without subgroup analysis
of the paediatric population (N = 8); (5) medical condition under
study was not asthma (N = 11); (6) intervention under study
did not include a WAP (N = 170); and (7) group difference in
co-interventions did not allow for the determination of the ’net
benefit’ of the WAP (N = 35). Of note, no RCT was excluded
for failing to meet our expanded definition of an action plan. In
other words, all RCTs met both the GINA and our definition of
a written action plan with perfect agreement between assessors on
this issue. Given the large number of exclusion, the references and
reasons for exclusion are listed for only for RCT with asthma as the
medical condition under study under ’Characteristics of excluded
studies’.
Included studies
Included Studies
A total of four citations met eligibility criteria, all of which were
full-text publications. The current review aggregated four trials,
representing 355 patients. No trial compared the efficacy of the
provision of a written action plan versus none in which all other
co-interventions were kept equal. All included trials compared one
type of action plan to another, namely the provision of a symptombased versus peak-flow-based action plan, with all other educational co-interventions kept equal. However, the peak-flow based
interventions differed in the intensity of monitoring: daily monitoring (Letz 2004; Wensley 2004) versus monitoring only when
symptomatic (Charlton 1990); a three-arm study (Yoos 2002) contributed data to both types of monitoring.
Characteristics of studies
Run-in Wensley 2004 included a four-week run-in period prior
to randomisation, while Yoos 2002 included a three-month runin period prior to randomisation. No run-in phase was reported
for the other trials.
Study duration The duration of the intervention phase was three
months for three studies (Letz 2004; Wensley 2004; Yoos 2002)
while the Charlton 1990 study included a 24-month intervention
phase. Yoos 2002 also included a one-year post-exit phone interview and medical record review of all patients who completed the
intervention phase.
Co-intervention applied to both treatment arms. Asthma education was provided in each study. One study included a nurse visit
every two week (Charlton 1990 1990). One study included a twoweek period of daily practice with their particular form of symptom monitoring (Yoos 2002). In addition, Yoos 2002 required that
all families received asthma education related to the pathophysiology of asthma, asthma triggers, medications, and treatment goals;
they were provided with written material reinforcing this information and received training in asthma symptom recognition, that is
early and late symptoms indicative of inadequate asthma control,
as well as in symptom management. Letz 2004 and Wensley 2004
provided an educational session for all children at enrolment.
Characteristics of patients
Age All trials focused on school-aged children with one study (Yoos
2002) also including teenagers: more specifically, the age range was
7 to 14 years (Wensley 2004), 6 to 12 years (Letz 2004) and 6 to
19 years (Yoos 2002a). Although the original exclusion criteria of
this review was meant to exclude adolescents aged 18 and above,
we included the study by Yoos et al., assuming the proportion of
participants 18 and 19 years old was likely small and because it
6
was the only included study examining the intervention in the
adolescent population. While Charlton 1990 included both adults
and children, the age range of the paediatric subpopulation was
not available.
Gender All studies included both male and female patients. A
larger proportion of males were recruited, with males making up
53.2%, 59% and 63.9% of the total sample size of the Wensley
2004; Yoos 2002a and Letz 2004 trials respectively. The proportion of males and females recruited into the Charlton 1990 was
not available. The male to female ratio across study groups within
each study were similar (Letz 2004: 60% PEF-group versus 68%
symptom group), except for one trial in which there was a larger
proportion of male in the peak flow group compared to the symptom group, 68% and 39% respectively (Wensley 2004).
Severity Asthma severity ranged from mild to severe: it was described as mild to moderate (Letz 2004) and moderate in Wensley
2004, and moderate to severe (Charlton 1990). The average severity of airway obstruction was moderate (FEV < 80%) in Letz 2004
and mild (FEV > 80%) in Yoos (1), although three visits to the ED
for asthma in the previous 12 months was an inclusion criteria for
Yoos (1). Wensley 2004 reported that while all participants met at
least BTS-2 severity level, 30% of the peak-flow-based and 20%
of the symptom-based group exceeded this severity level.
Recruitment set-up Patients were recruited from primary care
centres only (Yoos 2002a), from both primary and secondary care
centres (Wensley 2004), and from asthma clinics (Charlton 1990;
Letz 2004)
Action plan format
Person Targeted All studies formatted WAPs to target both children and parents.
Simplicity One study identified that the language and reading
level of the WAP instructions were at the 6th grade reading level
(i.e. a reading level achieved after six years of schooling or roughly
that of an 11 year old) (Letz 2004). Reading levels for all other
WAPs were not available.
Number of Steps The written action plan generally contained
three steps for both intervention groups in all but one trial (
Charlton 1990), which used four steps for PEF, and five for symptom-based WAP groups. In other words, most studies had only
one step-up before the step that recommended seeking medical assistance for both the PEF and symptom-based WAPs (Letz 2004;
Wensley 2004; Yoos 2002). Charlton 1990 had two and three stepups before seeking medical assistance in the PEF and Symptomsbased WAP respectively.
Colours and graphics associated with steps Three studies associated the steps of their WAP with the streetlight colour approach
(green-yellow-red) (Letz 2004; Wensley 2004; Yoos 2002). One
study did not specify if any colours or graphics were associated
with each step on the WAP (Charlton 1990).
Step recognition
Symptom-based WAP In the three-steps WAPs, step 1 referred
to ’ normal well-being’ while step 2 was associated with ’symp-
toms of asthma’ and step 3, with symptoms suggestive of ’ severe respiratory distress’. Symptoms were usually generic although
one trial (Yoos 2002) listed signs and symptoms of distress, which
were specific for each child after the child was trained in subjective asthma symptom recognition. Generic symptoms listed under
step 2 included persistent cough, dyspnea, wheezing and symptoms of common cold (Letz 2004) or increasingly severe asthma
symptoms (Yoos 2002). No specific description was provided by
Wensley 2004. Symptoms indicative of step 3 included: less than
two-hour relief following bronchodilator, shortness of breath during normal activities, uncontrolled coughing, or difficulty speaking (Letz 2004), “severe symptoms” (Wensley 2004), signs and
symptoms of distress specific for the child (Yoos 2002). In contrast, Charlton 1990 listed symptoms of asthma in four steps of
increasing severity with the last step being less than 30-minute
relief following bronchodilator and difficulty talking.
Peak flow-based WAP All studies established zones based on the
personal best PEF reading of the patient. In the three-steps WAPs,
Step 1 referred to peak normal above 70% (Wensley 2004) or
above 80% of personal best (Letz 2004; Yoos 2002). Step 2 was
a PEF below that of step 1 value but above 50% (Wensley 2004;
Yoos 2002) or 60% of personal best (Letz 2004). Step 3 referred
to a PEF less than 60% (Letz 2004) or 50% of personal best (
Wensley 2004; Yoos 2002). As for Charlton 1990, four steps were
provided, namely step 1 greater than 70%, step 2 ranged from
50% to 70%, and step 3 ranged from 30% to 50% and step 4 less
than 30%.
Intensity of monitoring There was two intensities of peak flow
monitoring namely, daily monitoring (Letz 2004; Wensley 2004;
Yoos 2002) or monitoring only when symptomatic (Charlton
1990; Yoos 2002). Generally, patients were instructed to record the
best of three consecutive peak flow readings daily (Letz 2004; Yoos
2002). All trials required a daily dairy for both symptom-based
group except for Letz 2004 who required recording on symptoms
only upon deterioration. Yoos 2002 required twice daily dairy
recording for all patients and Wensley 2004 required twice daily
recording for both groups using an electronic spirometer in the
blinded mode for the symptom group and in the unblinded mode
for the peak flow group. The number of daily recordings required
to be made my patients was not available for Charlton 1990 or
Letz 2004.
Action plan instructions
Step 1 Daily anti-inflammatory therapy with inhaled corticosteroid
constituted step 1 for both the symptom-based and peak flowbased self-management plans in all trials, except for Yoos 2002
which instructed patients to avoid triggers and take “daily preventative medication”, which was taken by 55% of patients. Charlton
1990 added an additional step which we considered as fitting between Step 1 and 2 which called for the two puffs of bronchodilator every four hours for the symptom-based WAP only.
Step 2 The initiation of ß2 agonist and the doubling of the dose
7
of inhaled steroids was the recommended instructions in all trials
(considered step 3 in Charlton 1990 symptom plan).
Step 3 The third step recommended that patients or parents were
instructed to call the office or present to the emergency room
(red zone) all but one trial (Charlton 1990). In addition, Wensley
2004 and Letz 2004 included the possible self-initiation oral prednisolone as part of the red zone while Charlton 1990 requested
the initiation of a course of oral prednisolone and contact with the
patient’s general practitioner (considered step in Charlton 1990
symptom plan).
Step 4 Charlton 1990 peak flow WAP called for the immediate
medical attention (considered step 5 in symptom based WAP).
Funding
None of the funding was provided by manufacturers or distributors of peak-flow meters. One study was partially funded by a
grant from the American Academy of Nurse Practitioners (Letz
2004), one study was funded by NIH grants (Yoos 2002a), and
one study was supported by grants from the United Kingdom
National Asthma Campaign (Wensley 2004). Only one trial was
noted to have received some form of private funding, from Glaxo
SmithKline, UK, (Wensley 2004).
one as poor quality with a PEDro score of 3 (Letz 2004). One
study was identified as concealing allocation (Yoos 2002). Allocation was clearly not concealed in one trial that assigned patients
according to their hospital number (Letz 2004) and whether allocation was concealed was unclear in two trials (Charlton 1990;
Wensley 2004). All trials except one assessed baseline comparability (Charlton 1990) and adequately followed up patients (Letz
2004). Blinding of patients, therapist or administrator of WAP
was not feasible in any trial. Only one study reported using blinded
outcome assessment (Yoos 2002). No study specified use of intention-to-treat principle.
In regards to patients’ selection, two studies noted how many patients were screened for eligibility (Yoos 2002; Wensley 2004).
Yoos 2002 randomised 168 (49.9%) of 337 eligible patients and
Wensley 2004 enrolled 117 (74.1%) of 158 eligible patients. In
addition, Wensley 2004 also provided the anthropometric and
baseline data for non-randomised persons. The characteristics of
included and excluded eligible patients studied by Charlton 1990
were not available.
Effects of interventions
Risk of bias in included studies
Primary outcome
All studies were parallel group designs. Three trials were identified as being truly randomised-controlled trial, while one trial (
Letz 2004) reported as a randomised trial actually used a quasirandomisation scheme. In this trial patients were allocated to one
of two interventions based on the last digit of their medication
record number as assigned by computer: patients with medical
record number ending in an odd number received the PEF-based
asthma action plan, whereas those with even numbered records
received a symptom-based asthma action plan.
Based on PEDro scores, one study was rated as being of good
quality with a PEDro score of 7 (Yoos 2002), two as fair quality
with PEDro scores 5 and 4 (Charlton 1990; Wensley 2004) and
Number of patients with asthma exacerbation requiring unscheduled medical or emergency department visits [Table
01.01]. All studies documented the number of patients requiring
at least one acute care visit. Children assigned to symptom monitoring were significantly less likely to require acute care visits for
asthma (RR 0.73; 95% CI 0.55 to 0.99; Analysis 1.1).
The number needed to treat to prevent one acute care visit is nine
(95% CI 5 to 138) (see Figure 1). The fail-safe N test was 1.93
indicating that only two trials reporting no group difference would
be needed to reverse this finding. There was too few studies to
assess the likelihood of publication or other bias via the funnel
plot.
8
Figure 1. Number Needed to Treat with a symptom based WAP (compared to a Peak Flow WAP) to avoid
one patient requiring acute care visit for asthma
Although there was no evidence of heterogeneity between trials,
we conducted the a priori planned subgroup analyses to examine
the potential effect of these variables on the risk of patients with
an acute care visit. Since all trials identified both the child and
family as targeted person, failed to report the reading level (with
the exception of Charlton 1990), used the personal best PEF as
reference for step identification, and step-up therapy with rescue
ß2-agonists and an increased dose of inhaled steroids, we were
unable to perform subgroup analysis on these factors.
Number of steps/colour and graphics [Tables 02.01 and 02.02]. In
the more than 3-step WAP with no graphics, significantly less children assigned to symptom-monitoring required acute care visit
(RR 0.55; 95% CI 0.33 to 0.94) while there was no group difference in the 3-step streetlight WAP (RR 0.80; 95% CI 0.56 to
1.13); however, there was no significant difference when the two
subgroups were compared with each other (chi2 = 1.28, 1 df, P =
0.26).
Intensity of peak flow monitoring [Table 02.03]. Significantly less
children assigned to symptom-based WAP required acute care visit
compared to peak flow monitoring only when symptomatic (RR
0.66; 95% CI 0.44 to 0.97) with no group difference when comparing symptom-based to daily peak flow monitoring (RR 0.82;
95% CI 0.53 to 1.28); again there was no significant difference
when the two subgroups were compared with each other (chi2 =
0.23, 1 df, P = 0.63).
Prescribed daily anti-inflammatory therapy [Table 02.04]. When
analysis was stratified according the percentage children on daily
anti-inflammatory medications for Step 1 (state of well being),
there was no group difference between trials in which 100% of
patients (Charlton 1990; Letz 2004; Wensley 2004) (RR 0.72;
95% CI 0.47 to 1.12) or less than 100% (55.1%) of children were
on daily anti-inflammatory medications (Yoos 2002) (RR 0.74;
95% CI 0.50 to 1.11). (chi2 = 1.73, 3 df, P = 0.63)
With only five between-group comparisons, there was insufficient
data to perform a meta-regression. Sensitivity analyses failed to
alter the strength of association when the analysis was restricted
9
to the two trials with high methodological quality (RR 0.74; 95%
CI 0.50 to 1.11). With all studies being published and none being
funded by producer of peak flow, sensitivity analyses on publication and funding status were irrelevant.
Secondary outcomes
Number of acute care visits per number of times STEP 2
(asthma symptoms) was activated [Table 01.02]. Two studies
provided sufficient data to calculate the rate of acute care visits
over the number of Step 2 initiations, indicative of perceived deterioration (Letz 2004; Wensley 2004). No significant difference
was noted between symptom monitoring and peak flow monitoring groups (RR 0.86; 95% CI 0.68 to 1.09). This is likely to be
an underestimate of the true confidence interval as some patients
may have contributed more than one acute care visit.
Number of patients with exacerbation requiring at least one
course of systemic steroids [Table 01.03]. Three studies documented the number of patients with exacerbation requiring at least
one course of systemic steroid (Charlton 1990; Letz 2004; Wensley
2004). No significant differences were noted in the number of
patients requiring systemic steroids between patients assigned to
symptom monitoring and peak flow monitoring (RR 0.40; 95%
CI 0.05 to 3.40).
Number of patients requiring hospital admissions [Table
01.04]. Three studies examined the number of patients requiring
hospital admission (Letz 2004; Wensley 2004; Yoos 2002). No
significant difference was noted in the number of patients requiring hospitalizations between symptom monitoring and peak flow
monitoring (RR 1.51; 95% CI 0.35 to 6.65).
Change in the number of days per week of symptoms [Table
01.05]. Yoos 2002) examined the change in the number of days
per weeks of symptoms experienced. Compared to symptom monitoring, children assigned to peak flow monitoring had a significantly greater reduction in the change of number of days per week
of symptoms recorded (MD 0.45 days; 0.04 to 0.86).
Number of days with symptoms [Table 01.06]. Only one study
compared the overall days per week patients experience symptoms
(Yoos 2002). No significant differences were noted between symptom monitoring and peak flow groups (MD 0.53 days; 95% CI 0.10 to 1.16).
Number of patients who missed school and/or school related
activities [Table 01.07]. Two studies reported the number of patients who missed school (Wensley 2004; Yoos 2002). No significant difference was noted between symptom and peak flow monitoring groups (RR 0.81; 95% CI 0.58 to 1.12).
Change in baseline percent predicted FEV1 value during three
months of intervention [Table 01.08]. Only one study examined the change in baseline % predicted FEV1 value during three
months of intervention (Yoos 2002). No significant difference was
noted between symptom and peak flow monitoring groups (MD
-3.46%; 95% CI -7.56 to 0.63).
Average % predicated FEV1 during three months of intervention [Table 01.09]. Two studies provided information on the aver-
age % predicted FEV1 during three-months of intervention (Yoos
2002; Wensley 2004). No significant difference was noted between
symptom and peak flow monitoring groups (MD -0.73%; 95%
CI -4.75 to 3.28).
Change in symptom score at three months [Table 01.10]. One
study examined change in symptom scores at three months (Yoos
2002). No significant differences were noted between symptom
and peak flow monitoring groups (MD 0.04; 95% CI -0.22 to
0.29).
Symptom score at 3-months [Table 01.11]. Symptom score was
assessed at the end of treatment in one study (Yoos 2002). There
was no significant differences in symptom scores between symptom and peak flow monitoring groups (MD 0.09; 95% CI -0.17
to 0.34).
Symptom scores at 1-year post-intervention [Table 01.12].
Symptom score was assessed 9-months post-end of treatment in
one study (Yoos 2002). There was no significant differences between symptom- and peak flow monitoring groups (MD -0.06;
95% CI -0.22 to 0.09).
Change in CHILD quality of life at three months [Table 01.13].
Two studies provided information on change in child quality of life
at 3-months (Wensley 2004; Yoos 2002). There was no significant
difference between symptom- and peak flow monitoring groups
(MD: -0.25; 95% CI: -0.55, 0.05).
Change in CHILD quality of life at 12 months [Table 01.14].
Change in child quality of life was assessed 9-months post-end
of treatment in one study (Yoos 2002). There was no significant
difference between symptom- and peak flow monitoring groups
(MD 0.83; 95% CI -0.27 to 1.93).
Change in PARENT quality of life at three months [Table
01.15]. Two studies provided information on change in parent
quality of life at three-months (Yoos 2002; Wensley 2004). There
was no significant differences between symptom- and peak flow
monitoring groups (MD 0.08; 95% CI -0.17 to 0.33).
Change in PARENTS quality of life at 1-year [Table 01.16].
Change in parent quality of life was assessed nine-months postend of treatment in one study (Yoos 2002). There was no overall
significant difference between symptom- and peak flow monitoring groups (MD -0.08; 95% CI -0.40 to 0.24).
Withdrawals from study [Table 01.17]. Withdrawal rate was reported by all studies. No overall differences were noted in the
number of study withdrawals (RR 1.00; 95% CI 0.37 to 2.70).
Number of CHILDREN who intended to continue using monitoring strategy [Table 01.18]. One study assessed children intention to continue using their assigned monitoring strategy (Yoos
2002). There was more children who intended to continue using
symptom-based over peak flow-based monitoring. (RR 1.21; 95%
CI 1.00 to 1.46).
Number of PARENTS who intended to continue using monitoring strategy [Table 01.19]. One study assessed parents intention to continue using the monitoring strategy that was assigned to
10
their child (Yoos 2002). There was no significant difference in the
intention of continue monitoring strategy between symptom- and
peak flow monitoring groups (RR 0.96; 95% CI 0.87 to 1.07).
DISCUSSION
This review identified four trials comparing symptom-based to
peak-flow based written action plans but was unable to identify
any trial comparing the benefit of providing versus not providing
a written action plan, when all other co-interventions were kept
similar. Children assigned to symptom-based action plan had a
significantly lower risk of exacerbations requiring an acute care
visit and intended more frequently to continue using their plan
after the study. Children assigned to peak flow-based action plans
experienced a greater reduction in the number of symptomatic
days per week. There was no significant difference between the
two types of written action plan for any other outcomes, namely
need for rescue oral steroids, admission, school absenteeism, lung
function, symptom scores, quality of life, or withdrawals.
The relative risk of exacerbation was 27% lower in children who
were prescribed an action plan based on symptoms instead of peakflow. Only nine children needed to receive an action plan based on
symptoms to prevent an exacerbation requiring an acute care visit.
While the beneficial effect is large, caution is advised in the interpretation of these results because only two trials showing no group
differences would be needed to loose statistical significance. Although the results were homogeneous between the five contributing between-group comparisons, we sought to investigate whether
any characteristics of the written action plan was associated with
greater protection. As the trials were similar, we could not evaluate
the effect of the targeted person, reading level, step recognition,
prescribed maintenance therapy or recommended step-up therapy
on the magnitude of the protection. The small number of relatively homogeneous studies precluded any firm conclusion regarding the number of steps, use of streetlight signs or other graphics,
and the intensity of peak flow monitoring on the main outcome.
Regarding secondary analyses, most outcomes showed no group
differences between peak flow and symptom based WAPs. However, children assigned to peak flow monitoring experienced a
greater reduction (by an extra half day) in the number of symptomatic days per week. There was no significant differences in
withdrawal between symptom and peak flow monitoring WAP,
and no adverse side effects were reported with the use of in these
studies. No unusual patient withdrawal or dropouts were observed
across the included studies (drop-outs ranged from 0% to 8%),
suggesting that both options were acceptable. Thus, the application of symptom or peak-flow based WAP in the paediatric population appears to satisfactory for children and parents, safe, and
not associated with any adverse effects.
Why would the symptom-based action plan be superior to peakflow based plans for reducing emergency visits? We speculate that
it may be due to (1) earlier recognition of exacerbations with symptoms than the peak flow threshold of 70% or 80% used, allowing
for earlier intervention for asthma symptoms (step 2), (2) perhaps
a higher threshold for presentation to the emergency room in face
of severe respiratory distress (step 3) and/or (3) the more acceptable monitoring strategy for child and hence better adherence.
Evidently, the first and last hypotheses are only valid if the proposed management is effective; a condition that is not necessarily
met for the advice provided in step 2 (asthma symptoms) or 3
(severe distress). The use of maintenance anti-inflammatory medication when the child is well (Step 1) has been clearly shown to
be the most effective means to maintain good asthma control and
prevent deterioration in children with persistent asthma (Adams
1999; Adams 2005; Adams 2005a; Pauwels 2003). With regards
to dealing with new asthma symptoms (step 2), the action plans
typically recommended two interventions namely a dose doubling
of maintenance inhaled steroids and the addition of rescue inhaled ß2-agonists as needed. Clinical trials have failed to show the
superiority of doubling the dose of inhaled corticosteroids (ICS)
over maintaining the same dose in adults (FitzGerald 2004; RiceMcDonald 2005) and in children (Garrett 1998; Volovitz 2001).
Thus, if the superiority of symptom-based action plan is based
on earlier recognition of symptoms of deterioration (step 2), then
earlier treatment with short-acting ß2-agonists likely plays the major role. In this review, three trials allowed the home initiation of
oral steroids (Charlton 1990; Letz 2004; Wensley 2004) but fail
to distinguish courses of oral steroids initiated at home from those
prescribed by the acute care physician. Of interest, in Charlton
1990, which allowed the home initiation of systemic steroids at an
earlier step for the peak-flow than the symptom-based group (step
3 versus 4), children managed based on peak-flow measures used
more rescue systemic steroids and still presented more often to the
emergency visits than their counterparts. These findings may be
due to the timing between the administration of oral steroids and
the instruction to present to the emergency department. By study
design, the peak-flow group in Charlton 1990 was instructed to
start oral steroids and then contact their physician. We speculate
that most physicians when made aware that the peak flow was less
than 50% of personal best, would have recommended an immediate medical visit, thus not allowing time for oral steroids enough
time to reduce airway inflammation and prevent an acute care
visit.
Irrespective of the efficacy of recommended treatment, there is
clear evidence supporting the first hypothesis, namely the earlier recognition of deterioration using symptoms rather than peak
flow measures (Chan-Yeung 1996; Gibson 1992; Gibson 1995).
Thus, one important issue is the concordance of step thresholds
between the symptom- and the peak-flow based action plans. In
other words, perhaps the peak flow cut-offs for step-up therapy
(step 2) corresponded to greater severity than the corresponding
11
symptom cut-offs, allowing for delayed intervention, if one is effective. All trials based the peak flow thresholds on personal best
rather than reference values, thus probably improving accuracy
although no comparative data were available to confirm this assumption. One important potential confounder is the adherence
to the recommendations. To determine if the observed benefit was
conferred truly conferred by the step-up therapy perhaps initiated
earlier, we examine the ratio of acute case visits over number of
times the step 2 was activated (outcome 01.02); only two small
studies contributed data thus prevented any firm conclusion due
to insufficient power.
Our second hypothesis implied that the threshold for presentation to acute care setting (step 3) may have identified exacerbations of lesser severity in the peak-flow than the symptom-based
groups, thus artificially increasing acute care visits in the peak flow
WAP group. A study with blinded peak flow monitoring for symptom-based action plan and unblinded monitoring for the peak
flow based group would contribute fascinating information on the
equivalence of the thresholds used. Although one study did use
this design (Wensley 2004), it failed to report any observation regarding the equivalence of the thresholds used. Of interest, the
need for medical attention was not only based on symptoms but
also failure to respond to short-acting bronchodilator in the symptom-based group while this requirement was consistently absent
in peak-flow based action plans. This may suggests that responsiveness to treatment should be considered as a critical indicator
for recommending urgent medical attention.
Thirdly, the symptom-based action plan may be associated with
better compliance to maintenance therapy (step 1), as well as to
steps 2 and 3 instructions. Non-compliance associated with selfmanagement plans are often related to failure to adhere to basic
recommendations related to asthma trigger avoidance, (Desjardins
1993) peak flow measurements (Verschelden 1996) and importantly daily preventive medication (Lacasse 2005). In this review,
more children of the symptom-based group intended to continue
using their action plan at the end of the study than those assigned
to the peak flow-based plan, presumably because of easier monitoring. Parents showed no preference. Does the more laborious
daily monitoring with peak flow measurements decreased adherence to treatment? In absence of adherence to monitoring, daily
management or step-up treatment, this important question cannot be answered. Clearly, adherence should be not only monitored
but may even be considered as an outcome.
Why would the peak flow-based action plan be more effective
in reducing the number of symptomatic days if it was associated
with more emergency visits? Perhaps, the half-day gain resulted
in longer treatment of the deterioration (step 2) in the peak flow
over the symptom-based groups, thus improving asthma control.
It is also possible that the gain was artificially induced by the twice
daily peak flow monitoring, thus allowing for earlier detection of
improvement than the once daily symptom monitoring.
To our knowledge, this is the first review to examine the efficacy of
WAPs in the paediatric population only. While Toelle 1993 have
examined the provision of WAP in adults and children, they included only one study that enrolled children and adults (Charlton
1990) with six adult trials. The present review included three additional strictly pediatric trials and one mixed adult and pediatric
trial (with sub-group paediatric data (Charlton 1990) for a total of
355 children. Thus, the result directly applies to school-aged children with mild to severe asthma; it should not be generalized to
preschool-aged children until trials are conduced in this age group.
Indeed, the targeted persons for the youngest children are clearly
parents who will be responsible for symptom recognition without
any substantial hope to validate their impression with peak flow
measures. While adherence to monitoring and instructions were
not reported, the selection of our primary outcome, the number
of children requiring acute care visits for asthma, provides a strong
basis for implementation; use of the symptom-based action plan
reduced health care resources utilisation in childhood asthma.
The results of this review are strengthened by its methods. This review only includes randomised controlled trials and one quasi-randomised controlled trial, thus reducing bias. Although there was
a significant imbalance in the male/female ratio between groups
in the Wensley paper, this imbalance is believed to be a chance
event, supported by the observation that there were no significant
differences for the other 12 baseline characteristics. We obtained
confirmation of methodology and data, as well as additional data
from all primary authors. There was no evidence of funding bias;
yet, there are not enough trials to rule out publication bias.
The findings should be interpreted in the light of the following limitations. First, only four studies were identified. The small number
of trials limits the power of detecting significant difference in secondary outcomes and hindered the conduct of our subgroup and
sensitivity analyses on our primary outcome to identify key determinants of an effective WAP. Secondly, as with most educational
interventions, blinding of intervention is difficult, thus explaining
the overall lower methodological quality of included studies than
possible with drug trials. Sensitivity analyses, although not powerful, revealed no evidence of bias, due to poor quality. Thirdly, several outcomes such as adherence to monitoring were not or inconsistently reported, thus preventing meta-analysis. Finally, despite
our extensive search, this systematic review identified no RCTs
addressing whether the provision or not of a WAP is an effective
addition to asthma education in children with asthma: this review
highlights the paucity of data in this area. Given the universal recommendation calling for the provision of a written action plan to
all children with asthma, there is need for trials evaluating the impact of providing or not providing a WAP with asthma education
in which all co-interventions were kept equal.
All included trials used our expanded definition of a written action
plan, i.e., including recommendations for daily management, in
addition to the management of exacerbations. While this review
12
does not provide any comparison between the traditional and our
expanded definition of action plan, there is sufficient literature to
support the efficacy of daily management in the prevention of exacerbations. There is insufficient evidence to recommend an optimal format and set of instructions for WAP in children. Although
it remains unclear which aspect or recommendations of the action
plan mediated the beneficial effect, it would appear reasonable to
build on prior experience and use the 3-step, streetlight colours/
graphics action plan with recommendation for daily anti-inflammatory therapy to serve as comparator for other plans.
If the symptoms-based written action plan is superior to a peakflow based plan, is there any further need for placebo-controlled
trials to prove the efficacy of providing an action plan per se? We
believe so because, in absence of such trials, there is no evidence to
confirm if peak-flow-based plans are superior, equivalent or inferior to not providing an action plan (placebo). Such study would
thus be ethically justified. In view of the low rate of provision of
action plans by physicians (Mangione-Smith 2005) clear evidence
for efficacy should be provided if one hopes to convince physicians that the extra time and burden of writing an action for every
asthmatic (in addition to completing the medical chart and the
prescription) is worth their effort.
Participation of both the parent(s) and the young school-aged child
are required for appropriate and optimal application of WAP; as
such child’s preference in monitoring should be favoured. Supported by children’s higher endorsement of ongoing use of symptom- over peak-flow based WAP and the uncertainty about matching symptom and peak-flow cut-offs, we would recommend that
peak flow-based WAP be reserved to poor perceivers or demonstrators or both.
AUTHORS’ CONCLUSIONS
Implications for practice
1. There is a gap in knowledge to support the provision of a
written action plan as essential element of asthma education to
reduce asthma morbidity in children.
2. In a plan recommending daily maintenance steroids with
step-up therapy using B2-agonist and increased steroids before
urgent medical consultation, the use of symptom-based written
plans is more effective than peak-flow based plan for preventing
exacerbations requiring an acute care visit and should probably
be favoured over peak flow monitoring for most school-aged
asthmatic children. Symptom-based action plans are preferred by
children. Peak-flow based action plans appear more effective in
reducing the number of symptomatic days but this finding may
be artificially induced by design. It seems reasonable to reserve
peak flow monitoring for children who are poor perceivers of
their asthma symptoms.
Implications for research
1. There is a need for RCTs comparing the efficacy of WAP
versus no WAP in which all other (educational and medical) cointerventions are kept equal, for all study participants; this
should be done in several settings (acute care, clinic, hospital)
and in different age groups (preschool-aged, school-aged, and
adolescents).
2. Further randomised controlled trials are also needed to
assess the efficacy of symptom-based versus peak flow-based
action plan with good documentation of important outcomes
such as symptoms, lung function, use of rescue b2-agonists,
quality of life and importantly, adherence to instructions.
Preference should be to report change from baseline for all
continuous outcomes, with complete reporting of standard
deviations.
3. In order to distinguish the efficacy of the WAP as
communication tool between health care professionals and
patient/parents over its specific treatment recommendation, we
suggest that future studies be sufficiently powered to measure
and report adherence and treatment as recommended by the
WAP, using medication dose counters. Adherence to monitoring
strategy should also be documented (e.g., daily peak flow
measurement versus measurement only when symptomatic)
using peak flow digital recording for example. Preference (or
intention to continue) use of monitoring strategy and action
plan should also be ascertained.
4. When comparing two types of action plans, it is critical to
ensure that the thresholds for action are similar. A study with
blinded peak flow monitoring for symptom-based action plan
and unblinded monitoring for the peak flow based group would
contribute fascinating information on the equivalence of the
thresholds used.
5. We are proposing the use of a new outcome termed “acute
care visits per number of times step 2 was initiated;” this
outcome adjusts for the step activations.
6. Due to the difficulty in blinding, randomised controlled
trials should ensure concealment of allocation, blinded
assessment of outcomes, minimizing drop-outs, using intention
to treat analysis, and consider a sham control procedure in order
to meet the standard for high methodological quality.
7. There is a need for the exploration of the cost/benefit ratio
of the WAP per se, symptom-based versus peak-flow-based WAP,
and its components of guided self-management.
ACKNOWLEDGEMENTS
We thank the Cochrane Airways Review Group, namely Toby
Lasserson and Liz Arnold for the literature search and ongoing
13
support; Christopher Cates and Peter Gibson for their constructive comments. We are indebted to the following corresponding authors: Ian Charlton, Kevin Letz, Kimberly Sidora-Arcoleo,
Michael Silverman, Diane Wensley, and Lorrie Yoos who kindly
cooperated to our request for information and confirmation of
methodology and data.
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exacerbation of asthma by withdrawal of inhaled corticosteroid.
Clinical & Experimental Allergy 1992;22(5):525–32.
Moseley 2002
Moseley CG, Herbert RD, Sherrington C, Maher CG. Evidence for
physiotherapy practice: a survey for the physiotherapy evidence
18
database (PEDro). Australian Journal of Physiotherapy 2002;48(1):
43–9.
NAEPP
National Asthma Education and Prevention Program. NAEPP
Expert Panel Report.
NIH Publication
Guidelines for the diagnosis and management of asthma. Bethesda
(MD):National Heart, Lung and Blood Institute; 2002. NIH
Publication 02-5075. (Available at: http://www.nhlbi.nih.gov/
guidelines/asthma/index.htm).
Oommen 2003
Oommen A, Lambert PC, Grigg J. Efficacy of a short course of
parent-initiated oral prednisolone for viral wheeze in children aged
1-5 years: randomised controlled trial. Lancet 2003;362(9394):
1433–8.
Pauwels 2003
Pauwels RA, Pedersen S, Busse WW, Tan WC, Chen Y, Ohlsson SV,
et al.Early intervention with budesonide in mild persistent asthma:
a randomised, double-blind trial. Lancet 2003;361:1071–6.
Renzoni 1999
Renzoni E, Forastiere F, Biggeri A, Viegi G, Bisanti L, Chellini E, et
al.Differences in parental- and self-report of asthma, rhinitis and
eczema among Italian adolescents. SIDRI collaborative group
[Studi Italiani sui disordini respiratrio dell’infanzia e l’ambeince].
European Respiratory Journal 1999;15:597–604.
Rice-McDonald 2005
Rice-McDonald G, Bowler S, Staines G, Mitchell C. Double daily
inhaled corticosteroids is ineffective in mild to moderate severe
attacks of asthma in adults. Internal Medicine Journal 2005;35(12):
693–8.
Steven 2002
Stevens CA, Wesseldine LJ, Couriel JM, Dyer AJ, Osman LM,
Silverman M. Parental education and guided self-management of
asthma and wheezing in the pre-school child: a randomized
controlled trial [comment]. Thorax 2002;57(1):39–44.
Turner 1998
Turner PG, Noertjojo K, Vedal S. Risk factors of near fatal asthma.
American Journal of Respiratory & Critical Care Medicine 1998;157:
1804–9.
van der Palen 1997
van der Palen J, Klein JJ, Rovers MM. Observance with inhaled
medication and self-treatment guidelines following a self
management and self-treatment guidelines following a selfmanagement programme in adult asthmatics. European Respiratory
Journal 1997;10:652–7.
Verschelden 1996
Verschelden P, Cartier A, L’Archeveque J, Trudeau C, Malo JL.
Compliance with and accuracy of daily self-assessment of peak
expiratory flows (PEF) in asthmatic subjects over a three month
period. European Respiratory Journal 1996;9:880–5.
Volovitz 2001
Volovitz B, Nussinovitch M, Finkelstein Y, Harel L, Varsano I.
Effectiveness of inhaled corticosteroids in controlling acute asthma
exacerbations in children at home. Clinical Pediatrics 2001;40(2):
79–86.
von Mutius 2000
von Mutius E. Presentation of new GINA guidelines for
paediatrics. The global initiative on asthma. Clinical &
Experimental Allergy 2000;30(Suppl 1):6–10.
Wolf 2002
Wolf FM, Guevara JP, Grum CM, Clark NM, Cates CJ.
Educational interventions for asthma in children (Cochrane
review). The Cochrane Database of Systematic Reviews 2002, Issue 4.
∗
Indicates the major publication for the study
19
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Charlton 1990
Methods
STUDY DESIGN
Randomized controlled trial
2 Parallel group
ALLOCATION
Allocated by random number charts. Whether allocation concealed was not reported.
PEDRO QUALITY RATING SCORE:
Random allocation: YES
Concealed allocation: NO
Baseline Comparability: NO
Between group comparison: YES
Blinding of subject: NO
Blinding of therapist: NO
Blinding of assessor: NO
Adequacy of follow-up: YES
Intention-to-treat analysis: NO
Point Estimate & measure of variability: YES
Total PEDro Score: 4
SAMPLE SIZE CALCULATION
No calculation of sample size provided
Participants
STUDY POPULATION
Adults and Children receiving prophylactic treatment for asthma and attending a nurse-led asthma clinic
SIZE OF STUDY POPULATION
69 Adults: 32 peak flow group, 37 symptom only group
46 children: 19 peak flow group, 27 symptom only group
CHARACTERISTICS OF INCLUDED STUDY PARTICIPANTS
INCLUSION CRITERIA
EXCLUSION CRITERIA
Patients who required maintenance treatment with steroids or nebulised salbutamol during the study
excluded from relevant analyses
Interventions
PEF versus Symptom-based
LENGTH OF INTERVENTION PHASE
24 months
TARGET
Self-management plans were targeted at both child and parents
EXPERIMENTAL GROUP
Peak flow management plan with the following description: IF PEAK FLOW IS GREATER THAN 70%
of predicted normal continuous maintenance treatment: (a) Bronchodilator two times a day or when
needed, (b) Inhaled steroid two times a day. IF PEAK FLOW IS LESS THAN 70% of normal: 1. Double
dose of inhaled steroid for number of days required to achieve previous baseline, 2. Continue on this
increased dose for same number of days, 3. Return to previous dose of maintenance treatment. IF PEAK
FLOW IS LESS THAN 50% of normal: 1. Start oral prednisolone 40 mg daily (20 mg for children) and
contact general practitioner, 2. Continue on this dose for the number of days required to achieve previous
20
Charlton 1990
(Continued)
baseline. 3. Reduce oral prednisolone to 20 mg daily (10 mg daily for children) for same number of days.
4. Start prednisolone. IF PEAK FLOW IS LESS THAN 30%: 1. Contact general practitioner urgently
or, if unavailable. 2. Contact ambulance or, if unavailable, 3. Go directly to hospital
CONTROL GROUP
Symptom only self management plan with the following description: WHEN YOU FEEL NORMAL
continue maintenance treatment: (a) Bronchodilator two times a day or when needed, (b) Inhaled steroid
two times a day. IF YOU GET A COLD OR START TO FEEL TIGHT use your bronchodilator two
puffs every four hours. IF YOU WAKE WITH WHEEZING AT NIGHT OR HAVE A PERSISTENT
COUGH: 1. Double dose of inhaled steroids for number of days it takes you to return to normal, 2.
Use bronchodilator two puffs every four hours. IF YOU BRONCHODILATOR ONLY LAST TWO
HOURS AND YOU FIND DOING NORMAL ACTIVITIES MAKES YOU SHORT OF BREATH: 1.
Start oral prednisolone 40 mg daily (20 mg daily for children) and contact general practitioner, 2. Continue
to use this dose for the number of days required to return you to normal, 3. Reduce oral prednisolone
to 20 mg daily (10 mg daily for children) for same number of days, 4. Start prednisolone. IF YOUR
BRONCHODILATOR LAST ONLY 30 MINUTES OR YOU HAVE DIFFICULTY TALKING call
the doctor immediately.
CO-INTERVENTION
Nurse visit every 2 weeks.
CHILDREN ON DAILY ANTI-INFLAMMATORY MEDICATION DURING INTERVENTION
PERIOD: 100%
Outcomes
HEALTH CARE RESOURCES UTILIZATION
Number of doctor consultations
MEDICATION CONSUMPTION
Number of courses of oral steroids
Number of courses of nebulised salbutamol treatments
Notes
Risk of bias
Item
Authors’ judgement
Description
Allocation concealment?
Unclear
Information not available (Cochrane Grade B)
21
Letz 2004
Methods
STUDY DESIGN
Quasi-randomized controlled trial
2 Parallel group
ALLOCATION
Allocation not concealed.
Random allocation: NO
Baseline comparability: YES
Blinding of therapist:: NO
Adequacy of follow-up: NO
Point estimate of variability: YES
No sample size calculation were reported
ROLE OF TREATMENT PHYSICIANS
Treating physicians were involved in the research project
Participants
STUDY POPULATION
Children aged 6 to 12 years of age, seen in an allergy and asthma clinic and having been diagnosed with
mild to severe persistent asthma. Persistent asthma defined as experience of symptoms of at least 2 times
per week, FEV1 equal to or less than 80% predicted and FEV1 or PEF variability of 12% or greater.
Number of children randomized: 51; 25 symptom-based, 26 peak flow-based
Number of children completing study: 50; 25 symptom-based, 25 peak flow-based
Age, median (range): 8.9 PEF, 9.4 Symptoms
Sex, male (%): 60% PEF, 68% Symptoms
Family History: 61.54% PEF, 56% Symptoms
Race, Caucasian (%): 100% PEF; 100% Symptoms
Severity, pre-bronchodilator FEV1: 76.75% PEF, 78.75% Symptoms
Total daily dosage of inhaled steroids: 434 PEF, 561 Symptoms
Patients with use of systemic steroids in year prior to randomization (%): 76.9% PEF, 72% Symptoms
INCLUSION CRITERIA:
Newly diagnosed with persistent asthma, based on patient history, examination, and pre-post-bronchodilator-pulmonary function testing.
EXCLUSION CRITERIA:
Previous use of WAP
Interventions
PEF versus Symptom-based
3 months
TARGET
Self-management plans were targeted at both child and parents with the reading/language of the WAP at
the 6th grade level
EXPERIMENTAL GROUP
22
Letz 2004
(Continued)
Peak flow-based plan
Individualized action plan included peak flow measurements that were estimated from the patient’s measured and predicted peak expiratory flow. Peak flow readings at or below which each step should be initiated were written into each subject’s action plan.
Yellow zone: Recommended when peak flow was less than 80% but greater than 60% of predicted best
Red zone: Recommended when peak flow was at or less than 60% of the predicted best
CONTROL GROUP
Symptom based
Green zone: Baseline therapy with inhaled corticosteroid
Yellow zone: Dose of inhaled steroid was doubled and b2 agonists were used every 4 hours. Instructions
listed common symptoms of asthma including persistent cough, symptoms or a common cold, and dyspnea
as indicators for initiation of Yellow Zone.
Red zone: Patient and/or parent instructed to call office or present to the emergency room. Red Zone
Initiated if relief following bronchodilator lasted less than 2 hours, if patient became short of breath doing
normal daily activities, if there was uncontrolled coughing, or if breathing made it difficult for the patient
to speak.
CO-INTERVENTION
1 educational session at enrolment for all children
PERIOD: 100%
Outcomes
WAP USAGE
Number of times plan was used
Step taken
HEALTH CARE RESOURCES UTILIZATION
Number of acute care visits
Number of telephone calls made to health care provider
MEDICATION CONSUMPTION
Number of systemic corticosteroid received
Notes
Risk of bias
Item
Description
Unclear
23
Wensley 2004
Methods
STUDY DESIGN
2 Parallel groups
ALLOCATION
Children were randomly allocated to groups. Whether allocation was concealed was not reported.
Sample size calculation provided with 80% power to detect a between group difference of 1.5 = 120
children
Participants
STUDY POPULATION
Children with physician-diagnosed asthma aged 7 to 14 years old
number eligible: 158
Number recruited: 117
Number randomized: 90: 46 control patients, 44 intervention patients
Number completed: 89: 45 control patients, 22 intervention patients
age, median (range): 12 (7-14) control, 11 (7-44) intervention [for non randomized children 10 (7-14)]
Sex, male (%): 39% control, 68% intervention [for non randomized children 48%]
Family history of asthma (%): 46% control, 39% intervention [for non randomized children 56%]
Severity, BTS-2 (%): 20% control, 30% intervention [for non randomized children 22%]
Ever-hospitalized (%): 40% controls, 43% intervention [for non-randomized children 30%]
INCLUSION CRITERIA
Physician-diagnosed asthma at least step 2 of the British Thoracic Society Guidelines for Asthma Management (regular inhaled corticosteroid therapy), stable treatment for 1 month, no other respiratory problem,
competent at spirometry and successful 4-week run-in period.
EXCLUSION CRITERIA
If they did not meet the inclusion criteria or were non-compliant during the run-up period
Interventions
PEF plus symptom-based self-management versus Symptom-based management alone
3-months
TARGET
Self-management plans were targeted at both child and parents
EXPERIMENTAL GROUP
Symptom plus PEF self-management (PF). Colour coded: GREEN, PEF MORE THAN 70%, few
symptoms carry on as usual; YELLOW, PEF BETWEEN 50 - 70% after beta-2 agonist, double-inhaled
corticosteroid as well as taking additional beta-2 agonists therapy; RED, PEF LESS THAN 50% after
24
Wensley 2004
(Continued)
taking additional inhaled beta-2 agonist, severe symptoms commence oral prednisolone and/or seek
medical help. The PEF levels for action were based on the child’s best previous PEF. Electronic spirometer
was performed in the unblinded mode.
CONTROL GROUP
Symptom self-management alone (S). Children were asked to perform electronic spirometer in the blinded
mode.
CO-INTERVENTION
1 educational session at enrolment for all children
PERIOD: 100%
Outcomes
PULMONARY FUNCTION TEST PEF FEV FUNCTIONAL STATUS Daily symptom score Proportion of symptom free days Episodes of wheezing Acute episodes Cold/runny nose Days absent from
school HEALTH CARE UTILIZATION Hospital admission A&E visit Emergency GP Emergency GP
MEDICATION CONSUMPTION Course of Prednisolone total days of double ICS MEDICATION
PRESCRIBED BY DOCTORS Antibiotic course
Notes
Risk of bias
Item
Description
Unclear
25
Yoos 2002
Methods
STUDY DESIGN
3 Parallel groups
ALLOCATION
Randomized by stratified random procedure based on race, age, and urban/non-urban setting. Authors
provided additional information to verify that allocation was concealed
Concealed allocation: YES
Blinding of assessor: YES
No sample size calculation was provided
Participants
STUDY POPULATION
School-aged children and adolescents with a diagnosis of asthma identified through computerized data
sets and chart reviews from 11 diverse primary care settings
number eligible: 337
Number recruited: 168
Number randomized: 168: 56 monitor symptoms group, 55 peak flow monitoring with symptoms, 57
daily peak flow monitoring
Number at 3 months post-intervention assessment: 156
Number at 1 year post-exit interview: 136: 56 monitor symptoms group, 55 peak flow monitoring with
symptoms, 57 daily peak flow monitoring
Number of chart reviews for health care utilization: 162
Race: 66% White, 24% Black, 10% other
SES: 51% upper, 49% lower
Gender: 41% female, 59% males
Age: 74% school-age, 26% adolescent. Mean age (SD) 10.9 (3.77) peak flow only when symptomatic;
10.8 daily peak flow; 10.8 symptom only
Geographic location: 34% urban, 66% non-urban
Percent of personal best PEF on baseline: 338.24 (97.34) peak flow only when symptomatic; 332 (103.3)
daily peak flow
Percent predicted FEV1: 91 (19) peak-flow only when symptomatic; 86.8 (16.8) daily peak flow; 90.5
(17.6) symptom only
Number of asthma-related health care visit in year prior to randomization: 5.19 (3.31) peak flow only
when symptomatic, 4.86 (2.62) daily peak flow, 4.58 (3.74) symptom only.
INCLUSION CRITERIA
Aged 6 to 19 years with more than three asthma-related visits in the previous 12 months from an Englishspeaking family. Child had not used a PFM in the previous 6-months and the family could not identify
26
Yoos 2002
(Continued)
person zones of the child
EXCLUSION CRITERIA
Children with mild asthma and were rarely symptomatic
Interventions
Symptom-based self-management versus peak-flow daily and when symptomatic versus peak-flow only
when symptomatic
LENGTH OF INTERVENTION PHASE3 months of intervention
1 year post-exit phone interview/medical records
ACTION PLAN DESCRIPTION
Personal action plan for all treatment groups listed routine asthma medication for the green zone, detailed
additional rescue medication use in the yellow zone, and asked family to contact the health care provider
in the red zone immediately
EXPERIMENTAL GROUP
Daily peak expiratory flow rate
Detailed additional rescue mediation use in the yellow zone based on symptoms and peak expiratory flow
rate
Green zone: You do not have any early warning signs and symptoms of asthma. Your green zone is: > 80%
of % personal best
Yellow zone: You will begin to notice early warning signs and symptoms of asthma, which for you are
[insert signs and symptoms]. Your yellow zone is: between 50% and 80% of & personal best
Red zone: Asthma signs and symptoms or respiratory distress are present, which for you are: Your red
zone is: < 50% of % personal best
SECOND EXPERIMENTAL GROUP
Symptom-time peak expiratory flow rate
rate
Green zone: You do not have any early warning signs and symptoms of asthma. Your green zone is: > 80%
of % personal best
Yellow zone: You will begin to notice early warning signs and symptoms of asthma, which for you are
[insert signs and symptoms]. Your yellow zone is: between 50% and 80% of & personal best
Red zone: Asthma signs and symptoms or respiratory distress are present, which for you are: Your red
zone is: < 50% of % personal best
CONTROL GROUP
Subjective symptom evaluation
rate
Green Zone: You do not have any early warning signs and symptoms of asthma.
Yellow Zone: You will begin to notice early warning signs and symptoms of asthma, which for you are
[insert signs symptoms].
Red zone: Asthma signs and symptoms of respiratory distress are present, which for you are [insert signs
and symptoms].
ACTION TO BE TAKEN AT ALL LEVELS:
Green Zone: Use prevention medications every day; stay away from your asthma triggers
Yellow Zone: Start using quick relief medication; keep taking this medication four times a day and up to
every fours if needed until all your signs and symptoms of asthma have been gone for 48 hours then stop;
keep taking all prevention medicines; call [add GP’s name] at [add contact information] if your signs and
symptoms of trouble are present for more than 24 hours or you are getting worse despite the use of quick
relief medicine; get rid of your asthma triggers
27
Yoos 2002
(Continued)
Red zone: Use your quick relief medicine now, call [add GPs name] at [add contact information] now;
remember, if [add child’s name] has severe signs and symptoms of respiratory distress, call 911 immediately
CO-INTERVENTIONS
All families received asthma education related to the pathophysiology of asthma triggers, medications, and
treatment goals, written material reinforcing this information and training in asthma symptom recognition,
early and late symptoms that indicate inadequate asthma control, and symptom management.
PERIOD
PEF monitoring alone: 55.6%
PEF monitoring with symptoms: 64.0%
Symptom monitoring alone: 46.2%
All groups: 55.1%
Outcomes
PULMONARY FUNCTION TES FEV FUNCTIONAL STATUS Missed school Composite symptom
score Number of days/week of symptoms Child and parent quality of life WAP USAGE Children who
intended to continue using monitoring strategy Parents who intended to continue using monitoring
strategy HEALTH CARE UTILIZATION Patients with at least one acute care visit at 3-months and 1
year Number of acute care visit at 3-months and 1 year MEDICATION PRESCRIBED BY DOCTORS
Systemic corticosteroid
Notes
Yoos (1) was created for purpose of subgroup analysis. Yoos (1) corresponds to the comparison daily peak
flow monitoring versus symptom monitoring.
Risk of bias
Item
Description
Yes
Study investigators unaware as to treatment group
assignment (Cochrane Grade A)
Yoos 2002a
Methods
As above
Participants
As above
Interventions
As above
Outcomes
As above
Notes
Yoos (2002a) was created for purpose of subgroup analysis. Yoos (2002a) corresponds to the comparison
symptom monitoring versus peak flow monitoring when symptomatic. See Yoos (2002) above for details
regarding methods, participants, interventions, and outcomes.
Risk of bias
Item
Description
28
Yoos 2002a
(Continued)
Yes
Study investigators unaware as to treatment group assignment (Cochrane Grade
A)
BTS: British Thoracic Society; FEV1: Forced expiratory volume in one second; GP: General Practitioner; PEF: Peak expiratory flow;
PFM: Peak Flow Meter; PF: Pulmonary function; WAP: Written Action Plan
Characteristics of excluded studies [ordered by study ID]
Adams 2004
Intervention was not a written action plan.
Alexander 1988
Amirav 1995
Bheeki 2001
Mixed population of adults and children in which no subgroup analyses was provided for the children population of the study
Bonner 2002
Unable to determine the ’net-benefit’ on the Written Action Plan due to the inclusion of co-interventions.
Brooks 1994
Brown 2002
Burkhart 2002
Callery 1998
Carswell 1989
Charlton 1994
Christiansen 1997
Study was not a randomized controlled trial.
Cicutto 2003
Clark 1986
Cohen 1979
Colland 1993
Couriel 1999
29
(Continued)
Cowie 2002
Dahl 1990
Deaves 1993
Study was not a randomized controlled trial.
Dolinar 2000
Evans 1999
Farber 2001
Fireman 1981
GRASSIC 1994
Patient population consisted for adults only.
Griffiths 2005
Hill 1991
Holzheimer 1995
Hughes 1991
Adult population only. No children included.
Indinnimeo 1994
Johnson 2002
Jones 1995
Kinnert 2004
Kubly 1984
Lahdensuo 1996
Lans 1997
Medication study. Main purpose was the examine the efficacy of double-dosing
LeBaron 1985
Lewis 1984
Madge 1997
Dublicate of Madge et al. (1997) Thorax paper in which it was not possible to determine the ’net-benefit’ on
the Written Action Plan due to the inclusion of co-interventions.
Martin 2003
Dublicate of Stevens et al. (2002) Thorax paper in which it was not possible to determine the ’net-benefit’ on
the Written Action Plan due to the inclusion of co-interventions.
30
(Continued)
Maslennikova 1998
McGhan 2000
McNabb 1985
Meagher 1999
Dublicate of the Wesseldine et al. (1999) Arch Dis Child paper.
Mitchell 1986
Mulvaney 2003
Duplicate publication of Stevens et al. Thorax 2003; 57(1): 39-44.
Parcel 1980
Perez 1999
Perrin 1992
Persaud 1996
Rakos 1985
Ronchetti 1997
Rubin 1986
Shields 1990
Smith 1986
Sockrider 2001
Stevens 2002
Szczepanski 1996
Talabere 1993
Toelle 1993
Turner 1998a
Weingarten 1985
Wensley (a)
Duplicate of Wensley et al. (2004) Americal Journal of Respiratory and Critical Medicie paper which is already
included in the review.
Wesseldine 1999
Duplicate of Wesseldine et al. (1999) Arch Dis Child paper in which it was not possible to determine the ’netbenefit’ on the Written Action Plan due to the inclusion of co-interventions.
31
(Continued)
Whitman 1985
Wilson 1997
Intervention did not employ a written action plan
32
DATA AND ANALYSES
Comparison 1. Peak flow-based self-management plan versus Symptom-based self-management plan
Outcome or subgroup title
1 Number of patients with at least
one acute care visits for asthma
1.1 Daily Peak Flow
1.2 Peak-flow when
symptomatic
2 Number of acute case visits per
number of times STEP 2 was
used (# visits/#STEP 2 taken)
2.1 Daily Peak Flow
3 Number of patients with
exacerbations requiring at least
one course of systemic steroids
standardized over 1 yr
3.1 Daily Peak Flow
3.2 Peak Flow when
symptomatic
4 Number of patients requiring
hospital admission
4.1 Daily Peak Flow
4.2 Peak Flow when
symptomatic
5 Change in the number of
symptomatic days per week
5.1 Daily Peak Flow
5.2 Peak Flow when
symptomatic
6 Number of symptomatic days
per week
6.1 Daily Peak Flow
6.2 Peak-flow when
symptomatic
7 Number of patients who missed
school
7.1 Daily Peak Flow
7.2 Peak-flow when
symptomatic
8 Change in baseline in %
predicted FEV1 value during
3-months of intervention
8.1 Daily Peak Flow
8.2 Peak Flow when
symptomatic
No. of
studies
No. of
participants
5
353
Risk Ratio (M-H, Fixed, 95% CI)
0.73 [0.55, 0.99]
3
2
224
129
0.82 [0.53, 1.28]
0.66 [0.44, 0.97]
2
74
0.86 [0.68, 1.09]
2
3
74
185
Risk Ratio (M-H, Random, 95% CI)
0.86 [0.68, 1.09]
0.40 [0.05, 3.40]
2
1
139
46
0.98 [0.34, 2.87]
0.04 [0.00, 0.61]
4
296
1.51 [0.35, 6.65]
2
2
131
165
2.08 [0.14, 31.91]
1.32 [0.22, 7.76]
2
168
Mean Difference (IV, Fixed, 95% CI)
0.45 [0.04, 0.86]
1
1
85
83
0.23 [-0.34, 0.80]
0.68 [0.10, 1.26]
2
168
0.53 [-0.10, 1.16]
1
1
85
83
0.19 [-0.70, 1.08]
0.87 [-0.02, 1.76]
3
245
0.81 [0.58, 1.12]
1
2
80
165
0.72 [0.42, 1.24]
0.87 [0.58, 1.30]
2
166
-3.46 [-7.56, 0.63]
1
1
83
83
-3.04 [-8.79, 2.71]
-3.9 [-9.72, 1.92]
Statistical method
Effect size
33
9 Average % predicted FEV1
value during 3-months of
intervention
9.1 Daily Peak Flow
9.2 Peak flow when
symptomatic
10 Change in symptom score at 3
months
10.1 Daily Peak Flow
10.2 Peak flow when
symptomatic
11 Symptom score at 3-months
post-intervention
11.2 Peak Flow when
symptomatic
12 Symptom score at 1-year postintervention
12.2 Peak flow when
symptomatic
13 Change in CHILD quality of
life at 3-months
13.2 Peak Flow when
symptomatic
14 Change in CHILD quality of
life at 1-year
14.2 Peak Flow when
symptomatic
15 Change in PARENT quality of
life at 3-months
15.2 Peak-flow when
symptomatic
16 Change in PARENT quality of
life at 1-year
16.2 Peak Flow when
symptomatic
17 Withdrawals for any reason
17.2 Peak flow when
symptomatic
18 Number of CHILDREN
who intend to continue using
monitoring strategy
18.2 Peak flow when
symptomatic
3
257
-0.73 [-4.75, 3.28]
1
2
85
172
2.0 [-5.68, 9.68]
-1.76 [-6.47, 2.95]
2
168
Mean Difference (IV, Random, 95% CI)
0.04 [-0.22, 0.29]
1
1
85
83
-0.09 [-0.28, 0.10]
0.17 [-0.03, 0.37]
2
168
0.09 [-0.17, 0.34]
1
1
85
83
Not estimable
-0.04 [-0.25, 0.17]
2
168
-0.06 [-0.22, 0.09]
1
1
85
83
-0.06 [-0.28, 0.16]
-0.07 [-0.29, 0.15]
3
257
-0.25 [-0.55, 0.05]
2
1
174
83
-0.31 [-0.67, 0.04]
-0.11 [-0.66, 0.44]
2
168
0.83 [-0.27, 1.93]
1
1
85
83
0.27 [-0.41, 0.95]
1.39 [0.71, 2.07]
3
257
0.08 [-0.17, 0.33]
2
1
174
83
0.10 [-0.19, 0.40]
0.02 [-0.47, 0.51]
2
168
-0.08 [-0.40, 0.24]
1
1
85
83
0.32 [-0.22, 0.86]
-0.3 [-0.70, 0.10]
5
3
2
355
226
129
1.00 [0.37, 2.70]
1.18 [0.32, 4.29]
0.79 [0.16, 3.80]
2
155
1.21 [1.00, 1.46]
1
1
79
76
1.31 [0.98, 1.75]
1.12 [0.87, 1.45]
34
19 Number of PARENTS who
intend to continue use of
monitoring strategy
19.2 Peak Flow when
symptomatic
2
150
0.96 [0.87, 1.07]
1
1
77
73
0.94 [0.81, 1.10]
0.99 [0.86, 1.13]
Comparison 2. Sub-group analysis of primary outcome: Number of patients with at least one acute care visit for
asthma
Outcome or subgroup title
1 Number of steps
1.1 3-Step WAP
1.2 More than 3-Step WAP
2 Colour
2.1 Streetlight
2.2 No colour
3 Intensity of PEF monitoring
3.1 Daily Peak Flow
3.2 Peak-flow when
symptomatic
4 100% anti-inflammatory
medication
4.1 100%
4.2 Less than 100%
No. of
studies
No. of
participants
5
4
1
5
4
1
5
3
2
353
307
46
353
307
46
353
224
129
0.73 [0.55, 0.99]
0.80 [0.56, 1.13]
0.55 [0.33, 0.94]
0.73 [0.55, 0.99]
0.80 [0.56, 1.13]
0.55 [0.33, 0.94]
0.73 [0.55, 0.99]
0.82 [0.53, 1.28]
0.66 [0.44, 0.97]
5
353
0.73 [0.55, 0.99]
3
2
185
168
0.72 [0.47, 1.12]
0.74 [0.50, 1.11]
Statistical method
Effect size
35
Analysis 1.1. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 1 Number of patients with at least one acute care visits for asthma.
Review:
Comparison: 1 Peak flow-based self-management plan versus Symptom-based self-management plan
Outcome: 1 Number of patients with at least one acute care visits for asthma
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Risk Ratio
0/25
0/25
0.0 [ 0.0, 0.0 ]
Wensley 2004
11/45
11/44
0.98 [ 0.47, 2.02 ]
Yoos 2002
10/28
28/57
0.73 [ 0.41, 1.28 ]
98
126
0.82 [ 0.53, 1.28 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Daily Peak Flow
Letz 2004
Subtotal (95% CI)
Total events: 21 (Symptom-based WAP), 39 (Peak-flow-based WAP)
Heterogeneity: Chi2 = 0.40, df = 1 (P = 0.53); I2 =0.0%
Test for overall effect: Z = 0.87 (P = 0.39)
2 Peak-flow when symptomatic
Charlton 1990
11/27
14/19
0.55 [ 0.33, 0.94 ]
Yoos 2002a
10/28
26/55
0.76 [ 0.43, 1.34 ]
55
74
0.66 [ 0.44, 0.97 ]
200
0.73 [ 0.55, 0.99 ]
Subtotal (95% CI)
Total (95% CI)
153
0.2
0.5
Favours symptom WAP
1
2
5
Favours PF-based WAP
36
Analysis 1.2. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 2 Number of acute case visits per number of times STEP 2 was used (#
visits/#STEP 2 taken).
Review:
Outcome: 2 Number of acute case visits per number of times STEP 2 was used (# visits/#STEP 2 taken)
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Weight
1/19
1/6
6.5 %
0.32 [ 0.02, 4.32 ]
22/27
20/22
93.5 %
0.90 [ 0.72, 1.12 ]
46
28
100.0 %
0.86 [ 0.68, 1.09 ]
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Daily Peak Flow
Letz 2004
Wensley 2004
Total (95% CI)
0.1 0.2
0.5
Favours Symptom WAP
1
2
5
10
37
Analysis 1.3. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 3 Number of patients with exacerbations requiring at least one course of
systemic steroids standardized over 1 yr.
Review:
Outcome: 3 Number of patients with exacerbations requiring at least one course of systemic steroids standardized over 1 yr
Study or subgroup
Symptom-based WAP
Peak-flow based WAP
n/N
n/N
Risk Ratio
Weight
Letz 2004
1/25
1/25
28.0 %
1.00 [ 0.07, 15.12 ]
Wensley 2004
5/45
5/44
44.6 %
0.98 [ 0.30, 3.14 ]
70
69
72.6 %
0.98 [ 0.34, 2.87 ]
0/27
9/19
27.4 %
0.04 [ 0.00, 0.61 ]
27
19
27.4 %
0.04 [ 0.00, 0.61 ]
88
100.0 %
0.40 [ 0.05, 3.40 ]
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
1 Daily Peak Flow
Subtotal (95% CI)
Total events: 6 (Symptom-based WAP), 6 (Peak-flow based WAP)
Heterogeneity: Tau2 = 0.0; Chi2 = 0.00, df = 1 (P = 0.99); I2 =0.0%
2 Peak Flow when symptomatic
Charlton 1990
Subtotal (95% CI)
Heterogeneity: not applicable
Total (95% CI)
97
Heterogeneity: Tau2 = 2.30; Chi2 = 5.75, df = 2 (P = 0.06); I2 =65%
0.01
0.1
Favours symptom WAP
1
10
100
38
Analysis 1.4. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 4 Number of patients requiring hospital admission.
Review:
Outcome: 4 Number of patients requiring hospital admission
Study or subgroup
Symptom-based WAP
Peak-flow -based WAP
n/N
n/N
Risk Ratio
Risk Ratio
Letz 2004
0/25
0/26
0.0 [ 0.0, 0.0 ]
Yoos 2002
1/26
1/54
2.08 [ 0.14, 31.91 ]
51
80
2.08 [ 0.14, 31.91 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Daily Peak Flow
Subtotal (95% CI)
Total events: 1 (Symptom-based WAP), 1 (Peak-flow -based WAP)
Wensley 2004
0/45
1/44
0.33 [ 0.01, 7.80 ]
Yoos 2002a
1/26
0/50
5.67 [ 0.24, 134.43 ]
71
94
1.32 [ 0.22, 7.76 ]
174
1.51 [ 0.35, 6.65 ]
Subtotal (95% CI)
Heterogeneity: Chi2 = 1.56, df = 1 (P = 0.21); I2 =36%
Total (95% CI)
122
0.1 0.2
0.5
Favours symptom WAP
1
2
5
10
39
Analysis 1.5. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 5 Change in the number of symptomatic days per week.
Review:
Outcome: 5 Change in the number of symptomatic days per week
Study or subgroup
Symptom-based WAP
N
Peak flow-based WAP
Mean(SD)
N
Mean Difference
Mean(SD)
Weight
IV,Fixed,95% CI
Mean Difference
IV,Fixed,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
28 -0.19 (1.11)
28
51.2 %
57 -0.42 (1.51)
57
0.23 [ -0.34, 0.80 ]
51.2 % 0.23 [ -0.34, 0.80 ]
Yoos 2002a
Subtotal (95% CI)
28 -0.19 (1.11)
55 -0.87 (1.56)
48.8 %
0.68 [ 0.10, 1.26 ]
28
55
48.8 % 0.68 [ 0.10, 1.26 ]
56
112
100.0 % 0.45 [ 0.04, 0.86 ]
Total (95% CI)
Test for subgroup differences: Chi2 = 1.18, df = 1 (P = 0.28), I2 =15%
-4
-2
Favours Symptom WAP
0
2
4
40
Analysis 1.6. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 6 Number of symptomatic days per week.
Review:
Outcome: 6 Number of symptomatic days per week
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
Mean Difference
N
Mean(SD)
N
Mean(SD)
28
2.87 (1.69)
57
2.68 (2.42)
Weight
IV,Fixed,95% CI
Mean Difference
IV,Fixed,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
28
49.9 %
57
0.19 [ -0.70, 1.08 ]
49.9 % 0.19 [ -0.70, 1.08 ]
Yoos 2002a
Subtotal (95% CI)
28
2.87 (1.69)
55
50.1 %
2 (2.37)
0.87 [ -0.02, 1.76 ]
28
55
50.1 % 0.87 [ -0.02, 1.76 ]
56
112
100.0 % 0.53 [ -0.10, 1.16 ]
Total (95% CI)
-4
-2
Favours Symptom WAP
0
2
4
41
Analysis 1.7. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 7 Number of patients who missed school.
Review:
Outcome: 7 Number of patients who missed school
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Weight
10/26
29/54
37.4 %
0.72 [ 0.42, 1.24 ]
26
54
37.4 %
0.72 [ 0.42, 1.24 ]
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
Wensley 2004
13/45
15/44
30.1 %
0.85 [ 0.46, 1.57 ]
Yoos 2002a
11/26
24/50
32.6 %
0.88 [ 0.52, 1.50 ]
71
94
62.6 %
0.87 [ 0.58, 1.30 ]
148
100.0 %
0.81 [ 0.58, 1.12 ]
Subtotal (95% CI)
Total (95% CI)
97
0.2
0.5
Favours Symptom WAP
1
2
5
42
Analysis 1.8. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 8 Change in baseline in % predicted FEV1 value during 3-months of intervention.
Review:
Outcome: 8 Change in baseline in % predicted FEV1 value during 3-months of intervention
Study or subgroup
Symptom-based WAP
N
Peak flow-based WAP
Mean(SD)
N
Mean Difference
Mean(SD)
Weight
IV,Fixed,95% CI
Mean Difference
IV,Fixed,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
26 0.43 (10.02)
26
50.6 %
57 3.47 (16.47)
57
-3.04 [ -8.79, 2.71 ]
50.6 % -3.04 [ -8.79, 2.71 ]
Yoos 2002a
Subtotal (95% CI)
28 0.43 (10.02)
49.4 %
55 4.33 (16.98)
-3.90 [ -9.72, 1.92 ]
28
55
49.4 % -3.90 [ -9.72, 1.92 ]
54
112
100.0 % -3.46 [ -7.56, 0.63 ]
Total (95% CI)
Test for subgroup differences: Chi2 = 0.04, df = 1 (P = 0.84), I2 =0.0%
-10
-5
0
5
10
Favours symptom WAP
43
Analysis 1.9. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 9 Average % predicted FEV1 value during 3-months of intervention.
Review:
Outcome: 9 Average % predicted FEV1 value during 3-months of intervention
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
Mean Difference
N
Mean(SD)
N
Mean(SD)
28
90 (14.87)
57
88 (20.61)
Weight
IV,Fixed,95% CI
Mean Difference
IV,Fixed,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
28
27.4 %
57
2.00 [ -5.68, 9.68 ]
27.4 % 2.00 [ -5.68, 9.68 ]
2 Peak flow when symptomatic
Wensley 2004
45
86.9 (15.4)
44
87.3 (13.3)
45.2 %
-0.40 [ -6.37, 5.57 ]
Yoos 2002a
28
90 (14.87)
55
94 (20.17)
27.5 %
-4.00 [ -11.66, 3.66 ]
Subtotal (95% CI)
73
99
72.6 % -1.76 [ -6.47, 2.95 ]
156
100.0 % -0.73 [ -4.75, 3.28 ]
Total (95% CI)
101
-10
-5
0
5
10
Favours symptom WAP
44
Analysis 1.10. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 10 Change in symptom score at 3 months.
Review:
Outcome: 10 Change in symptom score at 3 months
Study or subgroup
Symptom-based WAP
N
Peak-flow-based WAP
Mean Difference
Mean(SD)
N
Mean(SD)
28 -0.15 (0.44)
57
-0.06 (0.4)
Weight
IV,Random,95% CI
Mean Difference
IV,Random,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
28
50.9 %
57
-0.09 [ -0.28, 0.10 ]
50.9 % -0.09 [ -0.28, 0.10 ]
Yoos 2002a
Subtotal (95% CI)
28 -0.15 (0.44)
49.1 %
55 -0.32 (0.47)
0.17 [ -0.03, 0.37 ]
28
55
49.1 % 0.17 [ -0.03, 0.37 ]
56
112
100.0 % 0.04 [ -0.22, 0.29 ]
Total (95% CI)
-1
-0.5
Favours Symptom WAP
0
0.5
1
45
Analysis 1.11. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 11 Symptom score at 3-months post-intervention.
Review:
Outcome: 11 Symptom score at 3-months post-intervention
Study or subgroup
Symptomic-based WAP
N
Peak-flow-based WAP
Mean Difference
Mean(SD)
N
Mean(SD)
28 -1.44 (0.42)
57
-1.66 (0.6)
Weight
IV,Random,95% CI
Mean Difference
IV,Random,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
28
57
49.0 %
0.22 [ 0.00, 0.44 ]
49.0 %
0.22 [ 0.00, 0.44 ]
51.0 %
-0.04 [ -0.25, 0.17 ]
Yoos 2002a
Subtotal (95% CI)
28 -1.44 (0.42)
55
-1.4 (0.52)
28
55
51.0 % -0.04 [ -0.25, 0.17 ]
56
112
100.0 % 0.09 [ -0.17, 0.34 ]
Total (95% CI)
-1
-0.5
Favours Symptom WAP
0
0.5
1
46
Analysis 1.12. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 12 Symptom score at 1-year post-intervention.
Review:
Outcome: 12 Symptom score at 1-year post-intervention
Study or subgroup
Symptom-based WAP
N
Peak-flow-based WAP
Mean Difference
Mean(SD)
N
Mean(SD)
28 -1.56 (0.42)
57
-1.5 (0.6)
Weight
IV,Fixed,95% CI
Mean Difference
IV,Fixed,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
28
50.5 %
57
-0.06 [ -0.28, 0.16 ]
50.5 % -0.06 [ -0.28, 0.16 ]
Yoos 2002a
Subtotal (95% CI)
28 -1.56 (0.42)
55
49.5 %
-1.49 (0.6)
-0.07 [ -0.29, 0.15 ]
28
55
49.5 % -0.07 [ -0.29, 0.15 ]
56
112
100.0 % -0.06 [ -0.22, 0.09 ]
Total (95% CI)
-1
-0.5
Favours Symptom WAP
0
0.5
1
47
Analysis 1.13. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 13 Change in CHILD quality of life at 3-months.
Review:
Outcome: 13 Change in CHILD quality of life at 3-months
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
Mean Difference
Weight
IV,Fixed,95% CI
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Fixed,95% CI
Wensley 2004
45
0.27 (0.94)
44
0.73 (1.19)
45.2 %
-0.46 [ -0.91, -0.01 ]
Yoos 2002
28
0.55 (1.22)
57
0.6 (1.53)
24.9 %
-0.05 [ -0.65, 0.55 ]
1 Daily Peak Flow
Subtotal (95% CI)
73
70.1 % -0.31 [ -0.67, 0.04 ]
101
Yoos 2002a
Subtotal (95% CI)
28
0.55 (1.22)
55
0.66 (1.18)
29.9 %
-0.11 [ -0.66, 0.44 ]
28
55
29.9 % -0.11 [ -0.66, 0.44 ]
101
156
100.0 % -0.25 [ -0.55, 0.05 ]
Total (95% CI)
-1
-0.5
0
0.5
1
Favours symptom WAP
48
Analysis 1.14. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 14 Change in CHILD quality of life at 1-year.
Review:
Outcome: 14 Change in CHILD quality of life at 1-year
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
Mean Difference
N
Mean(SD)
N
Mean(SD)
28
1.07 (1.8)
57
0.8 (0.43)
Weight
IV,Random,95% CI
Mean Difference
IV,Random,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
28
50.0 %
57
0.27 [ -0.41, 0.95 ]
50.0 % 0.27 [ -0.41, 0.95 ]
Yoos 2002a
Subtotal (95% CI)
28
1.07 (1.8)
28
50.0 %
55 -0.32 (0.41)
1.39 [ 0.71, 2.07 ]
55
50.0 % 1.39 [ 0.71, 2.07 ]
112
100.0 % 0.83 [ -0.27, 1.93 ]
Total (95% CI)
56
-4
-2
0
2
4
Favours symptom WAP
49
Analysis 1.15. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 15 Change in PARENT quality of life at 3-months.
Review:
Outcome: 15 Change in PARENT quality of life at 3-months
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
Mean Difference
Weight
IV,Fixed,95% CI
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Fixed,95% CI
Wensley 2004
45
0.3 (0.87)
44
0.18 (0.93)
45.8 %
0.12 [ -0.25, 0.49 ]
Yoos 2002
28
0.54 (1.08)
57
0.47 (1.03)
27.7 %
0.07 [ -0.41, 0.55 ]
1 Daily Peak Flow
Subtotal (95% CI)
73
73.4 % 0.10 [ -0.19, 0.40 ]
101
Yoos 2002a
Subtotal (95% CI)
28
0.54 (1.08)
55
0.52 (1.08)
26.6 %
0.02 [ -0.47, 0.51 ]
28
55
26.6 % 0.02 [ -0.47, 0.51 ]
101
156
100.0 % 0.08 [ -0.17, 0.33 ]
Total (95% CI)
-1
-0.5
0
0.5
1
Favours symptom WAP
50
Analysis 1.16. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 16 Change in PARENT quality of life at 1-year.
Review:
Outcome: 16 Change in PARENT quality of life at 1-year
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
Mean Difference
N
Mean(SD)
N
Mean(SD)
28
0.12 (0.83)
57
-0.2 (1.72)
Weight
IV,Fixed,95% CI
Mean Difference
IV,Fixed,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
28
35.1 %
57
0.32 [ -0.22, 0.86 ]
35.1 % 0.32 [ -0.22, 0.86 ]
Yoos 2002a
Subtotal (95% CI)
28
0.12 (0.83)
55
64.9 %
0.42 (0.96)
-0.30 [ -0.70, 0.10 ]
28
55
64.9 % -0.30 [ -0.70, 0.10 ]
56
112
100.0 % -0.08 [ -0.40, 0.24 ]
Total (95% CI)
-1
-0.5
0
0.5
1
Favours symptom WAP
51
Analysis 1.17. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 17 Withdrawals for any reason.
Review:
Outcome: 17 Withdrawals for any reason
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Risk Ratio
Letz 2004
0/25
1/26
0.35 [ 0.01, 8.12 ]
Wensley 2004
1/46
0/44
2.87 [ 0.12, 68.68 ]
Yoos 2002
2/28
3/57
1.36 [ 0.24, 7.66 ]
99
127
1.18 [ 0.32, 4.29 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Daily Peak Flow
Subtotal (95% CI)
Charlton 1990
0/27
0/19
0.0 [ 0.0, 0.0 ]
Yoos 2002a
2/28
5/55
0.79 [ 0.16, 3.80 ]
55
74
0.79 [ 0.16, 3.80 ]
201
1.00 [ 0.37, 2.70 ]
Subtotal (95% CI)
Total (95% CI)
154
0.01
0.1
Favours Symptom WAP
1
10
100
52
Analysis 1.18. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 18 Number of CHILDREN who intend to continue using monitoring strategy.
Review:
Outcome: 18 Number of CHILDREN who intend to continue using monitoring strategy
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Weight
20/25
33/54
45.9 %
1.31 [ 0.98, 1.75 ]
25
54
45.9 %
1.31 [ 0.98, 1.75 ]
21/26
36/50
54.1 %
1.12 [ 0.87, 1.45 ]
26
50
54.1 %
1.12 [ 0.87, 1.45 ]
104
100.0 %
1.21 [ 1.00, 1.46 ]
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
Yoos 2002a
Subtotal (95% CI)
Total (95% CI)
51
0.5
0.7
1
1.5
2
Favours Symptom WAP
53
Analysis 1.19. Comparison 1 Peak flow-based self-management plan versus Symptom-based selfmanagement plan, Outcome 19 Number of PARENTS who intend to continue use of monitoring strategy.
Review:
Outcome: 19 Number of PARENTS who intend to continue use of monitoring strategy
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Weight
23/26
48/51
50.8 %
0.94 [ 0.81, 1.10 ]
26
51
50.8 %
0.94 [ 0.81, 1.10 ]
24/26
44/47
49.2 %
0.99 [ 0.86, 1.13 ]
26
47
49.2 %
0.99 [ 0.86, 1.13 ]
98
100.0 %
0.96 [ 0.87, 1.07 ]
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Daily Peak Flow
Yoos 2002
Subtotal (95% CI)
Yoos 2002a
Subtotal (95% CI)
Total (95% CI)
52
0.5
0.7
1
1.5
2
Favours symptom WAP
54
Analysis 2.1. Comparison 2 Sub-group analysis of primary outcome: Number of patients with at least one
acute care visit for asthma, Outcome 1 Number of steps.
Review:
Comparison: 2 Sub-group analysis of primary outcome: Number of patients with at least one acute care visit for asthma
Outcome: 1 Number of steps
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Risk Ratio
0/25
0/25
0.0 [ 0.0, 0.0 ]
Wensley 2004
11/45
11/44
0.98 [ 0.47, 2.02 ]
Yoos 2002
10/28
28/57
0.73 [ 0.41, 1.28 ]
Yoos 2002a
10/28
26/55
0.76 [ 0.43, 1.34 ]
126
181
0.80 [ 0.56, 1.13 ]
11/27
14/19
0.55 [ 0.33, 0.94 ]
27
19
0.55 [ 0.33, 0.94 ]
200
0.73 [ 0.55, 0.99 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 3-Step WAP
Letz 2004
Subtotal (95% CI)
2 More than 3-Step WAP
Charlton 1990
Subtotal (95% CI)
Total (95% CI)
153
0.2
0.5
Favours symptom WAP
1
2
5
55
acute care visit for asthma, Outcome 2 Colour.
Review:
Outcome: 2 Colour
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Risk Ratio
0/25
0/25
0.0 [ 0.0, 0.0 ]
Wensley 2004
11/45
11/44
0.98 [ 0.47, 2.02 ]
Yoos 2002
10/28
28/57
0.73 [ 0.41, 1.28 ]
Yoos 2002a
10/28
26/55
0.76 [ 0.43, 1.34 ]
126
181
0.80 [ 0.56, 1.13 ]
11/27
14/19
0.55 [ 0.33, 0.94 ]
27
19
0.55 [ 0.33, 0.94 ]
200
0.73 [ 0.55, 0.99 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Streetlight
Letz 2004
Subtotal (95% CI)
2 No colour
Charlton 1990
Subtotal (95% CI)
Total (95% CI)
153
0.2
0.5
Favours symptom WAP
1
2
5
56
acute care visit for asthma, Outcome 3 Intensity of PEF monitoring.
Review:
Outcome: 3 Intensity of PEF monitoring
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Risk Ratio
0/25
0/25
0.0 [ 0.0, 0.0 ]
Wensley 2004
11/45
11/44
0.98 [ 0.47, 2.02 ]
Yoos 2002
10/28
28/57
0.73 [ 0.41, 1.28 ]
98
126
0.82 [ 0.53, 1.28 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Daily Peak Flow
Letz 2004
Subtotal (95% CI)
Charlton 1990
11/27
14/19
0.55 [ 0.33, 0.94 ]
Yoos 2002a
10/28
26/55
0.76 [ 0.43, 1.34 ]
55
74
0.66 [ 0.44, 0.97 ]
200
0.73 [ 0.55, 0.99 ]
Subtotal (95% CI)
Total (95% CI)
153
0.2
0.5
Favours symptom WAP
1
2
5
57
acute care visit for asthma, Outcome 4 100% anti-inflammatory medication.
Review:
Outcome: 4 100% anti-inflammatory medication
Study or subgroup
Symptom-based WAP
Peak-flow-based WAP
n/N
n/N
Risk Ratio
Risk Ratio
11/27
14/19
0.55 [ 0.33, 0.94 ]
0/25
0/25
0.0 [ 0.0, 0.0 ]
11/45
11/44
0.98 [ 0.47, 2.02 ]
97
88
0.72 [ 0.47, 1.12 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 100%
Charlton 1990
Letz 2004
Wensley 2004
Subtotal (95% CI)
2 Less than 100%
Yoos 2002
10/28
28/57
0.73 [ 0.41, 1.28 ]
Yoos 2002a
10/28
26/55
0.76 [ 0.43, 1.34 ]
56
112
0.74 [ 0.50, 1.11 ]
200
0.73 [ 0.55, 0.99 ]
Subtotal (95% CI)
Total (95% CI)
153
0.2
0.5
Favours symptom WAP
1
2
5
WHAT’S NEW
Last assessed as up-to-date: 23 March 2006.
1 September 2008
Amended
Converted to new review format.
58
HISTORY
Protocol first published: Issue 2, 2005
Review first published: Issue 3, 2006
24 March 2006
New citation required and conclusions have changed
Substantive amendment
CONTRIBUTIONS OF AUTHORS
Sanjit K. Bhogal: Responsible for protocol development, study selection, data abstraction, methodology assessment, contact with
authors, data management and entry, data interpretation, analysis and writing of the final review.
Roger Zemek: Participated in protocol development, study selection, data abstraction, methodology assessment, data entry, data
interpretation, contact with authors and writing of the final manuscript.
Francine Ducharme: Supervising overall review from protocol development until analysis and writing of final review, and coordinated
contact with corresponding authors.
DECLARATIONS OF INTEREST
In the past five years, Francine Ducharme received some research funding and consultation fees from Glaxo Wellcome and Astra Zeneca
and gave CME conferences supported by Merck Frost. Sanjit Bhogal and Roger Zemek report no conflict of interest.
INDEX TERMS
Medical Subject Headings (MeSH)
∗
Patient Care Planning; Adolescent; Asthma [∗ drug therapy; etiology]; Randomized Controlled Trials as Topic
MeSH check words
Child; Humans
59

Written action plans for asthma in children (Review) The Cochrane Library

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