Asthma self management education with regular healthcare professional review or written action plans or both in adults
Abstract
Objectives
This is a protocol for a Cochrane Review (intervention). The objectives are as follows:
To evaluate the effectiveness of asthma self management education, self monitoring and either: (1) regular review by a health care provider, or (2) use of a written action plan, or (3) both on patient outcomes. The specific questions addressed are:
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Do asthma self management education, self monitoring and either regular review by a healthcare provider or use of a written action plan, or both, lead to improved outcomes in asthma?
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What are the characteristics of those programmes that lead to measurable changes in health outcomes?
Background
Description of the condition
Asthma is a chronic respiratory condition causing inflammation of the lungs, as well as structural and related functional remodelling of the airways. It is characterised by recurrent attacks of breathlessness and wheezing, which vary in severity and frequency from person to person. During an asthma attack the lining of the bronchial tube swells, causing a narrowing of the airways that reduces the flow of air into and out of the lungs (WHO 2011). Evidence suggests asthma currently affects 300 million people globally (Masoli 2004) and is estimated to account for one in every 250 deaths worldwide, many of which are preventable (Masoli 2004). Levels of asthma vary widely between countries (prevalence percentages include: Scotland 18.4%, England 15.3%, New Zealand 15.1%, Canada 14.1%, Brazil 11.4%, USA 10.9%, Israel 9%, South Africa 8.1%, Germany 6.9%, Japan 6.7%, Italy 4.5%, Bangladesh 3.8%, Taiwan 2.6%, Switzerland 2.3%, Greece 1.9% and Indonesia 1.1% (EFA 2004; Masoli 2004)). Asthma is the 10th leading contributor to the overall burden of disease in Australia (AIHW 2010), affecting 14.7% of all Australians (Braman 2006; AIHW 2008). Asthma has been an Australian National Health Priority since 1996, with one in five Australians diagnosed with asthma at some point in their lives (AIHW 2008). One study suggests a cumulative incidence of asthma to middle age being 37% (Burgess 2008). In a calendar year, asthma is reported to account for 2.4 million general practice encounters, 105,000 emergency department visits and 40,000 hospital admissions (0.5% of all admissions) in Australia (AIHW 2005). The asthma burden across health care is significant and increasing (Bahadori 2009), with costs in the developed world estimated at USD 300 to 1300 per patient per year (Braman 2006). The effects of asthma on quality of life are also significant. In a recent survey, 25% of adults with asthma rated their health as only 'fair‐poor' compared with 14% of adults without asthma (AIHW 2010).
The causes of asthma are not completely understood, however known risk factors for developing asthma include inhaling asthma triggers, such as allergens, tobacco smoke and chemical irritants. Asthma is incurable, however appropriate management can control the disorder and enable people to enjoy a high quality of life (WHO 2011). Care of people with asthma includes routine and urgent management across primary and tertiary care. However due to suboptimal long‐term care and delays in obtaining help during acute exacerbations the mortality and morbidity related to asthma is still a major health concern (Braman 2006). The subsequent burden of disease is steadily increasing, resulting in confounded pressures on healthcare systems, governments, families and patients themselves (Masoli 2004). This morbidity has been attributed to suboptimal delivery of care, which includes under‐treatment with corticosteroids, limited knowledge and poor asthma self management skills amongst patients with severe asthma (Gibson 1993; Kandane‐Rathayake 2009).
Description of the intervention
Self management of asthma incorporates a range of strategies including education, self monitoring of the condition, regular review by a healthcare provider and the use of a written action plan (Gibson 2004). Asthma education programmes are aimed at improving patients' knowledge, understanding and self management of asthma by providing information about asthma and its management (Wolf 2008; Tapp 2010). Self monitoring of asthma involves the regular measurement of either peak expiratory flow or symptoms. Regular review consists of regular consultation with a healthcare provider during the intervention period for the purpose of reviewing the patients' asthma status and medications. A written action plan is an individualised written plan produced for the purpose of patient self management of asthma exacerbations, which informs participants about when and how to modify medications in response to worsening asthma and how to access the medical system in response to worsening asthma (Gibson 2004; Rank 2008; Toelle 2009; Walters 2010).
How the intervention might work
Self management educational interventions are aimed at improving the patient's knowledge and self management of the condition by various means including, but not limited to, improved compliance with medication regimes and prompt attention to exacerbations. Self management includes ongoing management of asthma and self monitoring of the condition, as well as use of the written action plan in case of worsening symptoms or an exacerbation (NACA 2006). Improved self management is likely to improve indices which measure control of asthma such as symptom scores, nocturnal symptoms, health‐related quality of life and lung function. For example, a systematic review based on publications from 2006 and earlier documented significant improvements in forced expiratory volume in one second (FEV₁) and mean peak flow (Bravata 2007). In 2006, the Global Initiative for Asthma (GINA) incorporated guided self management and treatment goals into their guidelines (Kroegel 2009). Self management is also likely to reduce asthma admissions, emergency room visits, unscheduled healthcare visits, days lost from work or school, the need for courses of oral corticosteroids and costs to the healthcare industry. However, the effectiveness of any self management programme may be dependent upon the population (for example, socioeconomic status), level of family/social support, patient attitudes and knowledge about their condition or healthcare setting (Mangan 2007).
Why it is important to do this review
Most asthma deaths are preventable as they are related to inadequate ongoing medical care and delays in obtaining medical help during exacerbations (James 2005; Braman 2006). A number of controlled trials have been conducted to identify the effectiveness of self management education with a combination of either regular practitioner review, written action plans, or both, although the influence of programme characteristics on health outcomes has not been examined in adults. Whilst there is a general agreement of programme effectiveness to improve patient knowledge, the impact on health outcomes is not as well understood. As such, consolidation of the available evidence is required to guide clinical practice improvements and future research. This review will be conducted to address these issues. Specifically, it will examine the strength of evidence supporting Step 6 of the Australian Asthma Management Plan, 'educate and review regularly' (NACA 2006), in addition to guidelines worldwide (NHLBI 2007; SIGN 2011) in order to identify whether health outcomes are influenced by self management interventions. This review replaces a previous similar Cochrane Review (Gibson 2009) which is out of date and is no longer being updated.
Objectives
To evaluate the effectiveness of asthma self management education, self monitoring and either: (1) regular review by a health care provider, or (2) use of a written action plan, or (3) both on patient outcomes. The specific questions addressed are:
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Do asthma self management education, self monitoring and either regular review by a healthcare provider or use of a written action plan, or both, lead to improved outcomes in asthma?
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What are the characteristics of those programmes that lead to measurable changes in health outcomes?
Methods
Criteria for considering studies for this review
Types of studies
We will include randomised trials (RCTs) that study the effects of asthma self management education and self monitoring with either regular review by a healthcare provider, the use of a written action plan, or both, on health outcomes in adults with asthma.
We will include cluster‐randomised controlled trials, however, we will exclude quasi‐randomised controlled trials.
Types of participants
We will include trials involving adults over the age of 16 years with asthma (defined by doctor's diagnosis or objective criteria such as the American Thoracic Society guidelines).
Types of interventions
We will categorise interventions based on whether, in addition to asthma education, they involved self monitoring of peak expiratory flow or symptoms, regular review by a healthcare provider and use of an individualised written action plan. We will categorise interventions that involve all four components ‐ self management education, self monitoring of asthma, regular review and a written action plan ‐ as 'optimal self management'. We will categorise interventions that involve three components only ‐ self management education and self monitoring with either regular review or a written action plan ‐ as 'suboptimal self management'.
We will exclude interventions involving two components or fewer and record reasons for exclusion in the 'Characteristics of excluded studies' table.
Intervention characteristics
Patient asthma education: a programme that provides information about asthma and its management in one or more of the following forms: written, verbal, visual or audio. It may be interactive or non‐interactive, structured or unstructured. Minimal education is characterised by the provision of written material alone or the conduct of a short unstructured verbal interaction between a healthcare provider and a patient where the primary goal is to improve patient knowledge and understanding of asthma. Maximal education provides information using both interactive and non‐interactive methods.
Self monitoring: consists of the regular measurement of either peak expiratory flow or symptoms (whether or not recorded in a diary).
Regular review: consists of regular consultation with a healthcare provider during the intervention period for the purpose of reviewing the patient's asthma status and medications. This may occur either as a formal part of the intervention or the patient may be advised to see their own doctor on a regular basis. Interventions are classified as having 'regular review' either inside the programme (if the patient was seen as a part of the programme) or outside the programme (if the patient was merely advised to seek regular medical review).
Written action plan: an individualised written plan produced for the purpose of patient self management of asthma exacerbations. The action plan is characterised by being individualised to the patient's underlying asthma severity and treatment and outlining:
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when and how to modify medications in response to worsening asthma; and
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how to access the medical system in response to worsening asthma.
Types of outcome measures
Primary outcomes
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The primary outcome will be severe asthma exacerbations as defined in the American Thoracic Society (ATS)/European Respiratory Society (ERS) asthma outcomes task force (Reddel 2009). We will report on the components of this definition, which include asthma exacerbations requiring hospital admissions, emergency room visits and/or oral corticosteroid use.
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Quality of life (validated; health‐related)
Secondary outcomes
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Unscheduled doctor visits for asthma
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Days lost from work or school
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Nights with disturbed sleep
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Lung function parameters (FEV₁, peak expiratory flow (PEF))
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Use of rescue medications
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Asthma symptom scores
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Adverse events
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Mortality
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Markers of airway inflammation
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Health‐related costs
Search methods for identification of studies
Electronic searches
We will identify trials from the Cochrane Airways Group Specialised Register of trials (CAGR), which is derived from systematic searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, AMED and PsycINFO, and handsearching of respiratory journals and meeting abstracts (please see Appendix 1 for further details). We will search all records in the CAGR coded as 'asthma' using the following terms:
(education* OR "self management" OR self‐management or self‐care or "self care")
We will also conduct a search of ClinicalTrials.gov. We will search all databases from their inception to the present and there will be no restriction on language of publication.
Searching other resources
We will check reference lists of all primary studies and review articles for additional references. We will contact authors of identified trials and ask them to identify other published and unpublished studies. We will also contact manufacturers and experts in the field.
Data collection and analysis
Selection of studies
We will divide the references for screening between three review authors and at least two of us will assess each reference for potential inclusion using the title, abstract and descriptors. We will resolve disagreement through discussion or referral to a third party.
Data extraction and management
One review author (AR, TS or KC) will extract data for each eligible study and this will then be checked by a second review author. We will extract the following data using a standardised data extraction form prior to entry into RevMan 5 software:
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Methods: country/setting of trial, design, aim/objective, study site, methods of statistical analysis, sample size.
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Participants: demographics such as age, gender, ethnicity and socioeconomic level; n‐values, recruitment and completion, recruitment means, asthma severity.
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Interventions: setting of intervention, primary care versus hospital based (severity of asthma differs in these settings and this may influence the ability to detect a change in outcome measures), description of intervention and control, duration (e.g. number of sessions, hours of teaching).
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Outcomes: methods of outcome collection, follow‐up periods and pre‐specified primary and secondary outcome data including: hospital admissions, emergency room visits, courses of oral corticosteroids, unscheduled doctor visits, days lost from work or school, forced expiratory volume in one second (FEV₁), peak expiratory flow rates (PEF), use of 'rescue' (or reliever) medications, quality of life, asthma symptoms scores, markers of airway inflammation, health‐related costs, asthma knowledge and skills.
Assessment of risk of bias in included studies
One review author will independently assess risk of bias for each study and this will be checked by a second review author using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Any disagreement will be resolved by discussion. We will assess the risk of bias according to the following domains.
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Allocation sequence generation
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Concealment of allocation
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Blinding of participants and investigators
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Incomplete outcome data
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Selective outcome reporting
We will note other sources of bias. We will grade each potential source of bias as a low, high or unclear risk of bias according to the Cochrane grading criteria in section 8.6 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
Measures of treatment effect
We will select outcome measures for RCT studies in accordance with Cochrane Collaboration standards (Higgins 2011). For dichotomous outcome data (e.g. rescue medication use, unscheduled doctor visits), we will calculate odds ratios (OR) and risk ratios (RR) as appropriate. For continuous outcomes (e.g. length of stay in days, FEV₁), we will calculate mean difference (MD) or standardised mean difference (SMD) accordingly. Where continuous and dichotomous data are presented for the same outcome from different studies, we will pool data using the generic inverse variance method as per section 9.4.6 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
We aim to conduct an intention‐to‐treat analysis as we anticipate a relatively large amount of subject attrition from included studies. For cluster‐RCTs we will perform intention‐to‐treat analysis at the level of the individual whilst accounting for clustering in the data, as described under 'Unit of analysis issues'. We will assess clustered participants in the group to which they were randomised in the same manner as standard RCT subjects.
Unit of analysis issues
We will reanalyse studies found to contain unit of analysis errors if data are available. Unit of analysis errors are found in studies that allocate participants to treatment or control in clusters (e.g. hospitals or doctor clinics), but analyse the results by individual participants. This can result in overestimation of the statistical significance of the results by not accounting for the clustering of individuals in the data (Rooney 1996; Ukoumunne 1999). Where studies do not include adjustments for clustering, we will reduce the size of the trial to the effective sample size (Rao 1992) using the original sample size from each study, divided by a design effect of 2.63 which is consistent with other asthma self management intervention designs (Clark 2006) and as per recommendations in the Cochrane Handbook for Systematic Reviews of Interventions, section 16.3.4 (Higgins 2011).
Dealing with missing data
Where statistics essential for analysis are missing and cannot be calculated from other data, we will attempt to contact the authors to obtain data.
Assessment of heterogeneity
We will use a combination of the I2 statistic, Chi2 test, visual inspection of characteristics of included studies and visual inspection of forest plots to measure heterogeneity among the trials in each analysis. For the I2 statistic we will consider a value above 50% as significant heterogeneity. If we identify significant heterogeneity we will explore it through the pre‐specified subgroup analyses (as per chapter 9.5.3 of the Cochrane Handbook for Systematic Reviews of Interventions; Higgins 2011) and report it in the text.
Assessment of reporting biases
Providing the inclusion of 10 studies or more, we will assess potential reporting biases using a funnel plot. Asymmetry in the plot could be attributed to publication bias, but may well be due to true heterogeneity, poor methodological design or artefact. In case of asymmetry, we will include contour lines corresponding to perceived milestones of statistical significance (P = 0.01, 0.05, 0.1 etc.) to funnel plots, which may help to differentiate between asymmetry due to publication bias from that due to other factors (Higgins 2011). In instances of fewer than 10 studies, we will explore potential reporting biases within the 'other bias' section in the 'Risk of bias' tables.
Data synthesis
We will conduct meta‐analysis only if relevant, valid data are available from at least two studies of the same design, with interventions that are conceptually similar (e.g. all interventions that include 'optimal self management') and measure the same outcome. We will use a random‐effects model for all meta‐analyses as we believe there is unlikely to be a single treatment effect across populations and interventions.
Subgroup analysis and investigation of heterogeneity
The background pharmacological treatment for asthma has changed substantially since the original version of this review was written (Gibson 2009) and since the first paper on asthma treatment was published. This therapy also modifies the key outcome measures of quality of life and health care utilisation. We will conduct subgroup analyses to assess this effect and also examine the change in event rates over time in the control group as a way of tracking this effect.
In addition, we plan to carry out the following subgroup analyses:
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optimal self management versus usual care;
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suboptimal self management versus usual care;
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education + self monitoring + regular medical review;
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education + self monitoring + written action plan.
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Sensitivity analysis
Providing a sufficient number of studies merit inclusion and where we encounter significant heterogeneity as defined under 'Assessment of heterogeneity', we will conduct sensitivity analysis by removing studies judged to be at high risk of bias for sequence generation and allocation concealment.
