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non pharmacological interventions for asthma

Home non pharmacological interventions for asthma

A/Prof. Helen Reddel “How to Design and Interpret Studies of Non-Pharmacological Interventions for Asthma”

As part of our ongoing seminar series, the Centre of Excellence in Severe Asthma hosted Prof. Helen Reddel for a webinar on “How to Design and Interpret Studies of Non-Pharmacological Interventions for Asthma” on 28 July, 2015.

Presentation Summary:

Non-pharmacological approaches are an important aspect of asthma management. These approaches are used in combination with medications. Approaches include avoidance of environmental exposures, physical activity and educational interventions.

High-level evidence is available for some non-pharmacological approaches. These include avoidance of tobacco smoke exposure, physical activity, healthy diet and avoidance of medications that worsen asthma. Unfortunately, high-level evidence is limited for most non-pharmacological strategies.

To generate high-quality evidence, careful consideration must be made to study design and analysis. Useful guidance for non-pharmacological treatment trials is available in from the CONSORT Group (Boutron, Ann Intern Med, 2008).

This presentation outlines factors that to consider when in non-pharmacological trials for asthma. Key factors include a clear statement of the research question, the choice of comparator groups, outcome measures, study blinding and patient involvement. Through careful consideration of these factors high quality research of non-pharmacological interventions is possible.

 Key Points:

  • Asthma management is not just about drug treatment
  • Many non-pharmacological strategies have been proposed in asthma management
  • High-quality evidence for many of these interventions is limited
  • High-level evidence is available for avoidance of tobacco smoke exposure and medications that worsen asthma and promotion of physical activity and healthy diet
  • Quality issues in non-pharmacological studies relate to study design, selection of patient populations, recruitment, intervention approaches, outcome measures, analysis and meta-analysis
  • A CONSORT checklist extension provides guidance for non-pharmacological treatment trials (Boutron, Ann Intern Med, 2008)
  • When planning a study, it is important to consider whether the study is a proof-of-concept (efficacy) versus an implementation study (effectiveness)
  • Selection of the treatment comparator can be active or inactive
  • Active comparators include current best practice, matched interventions for non-specific components and alternative treatment
  • Inactive comparators include placebo or sham treatment
  • Selection of the same comparator groups as other clinical trial studies can facilitate meta-analysis
  • It is desirable that comparator groups be matched for the level of contact with health professionals, as healthcare contact has effects on outcomes
  • Including sufficient detail in study methods is important, to ensure reproducibility across sites and to support blinding
  • Regulatory requirements are lacking for non-pharmacological interventions, compared to drugs and medical devices
  • There is less ability to blind non-pharmaceutical interventions, which increases the potential for sampling bias. Blinding the specific study hypothesis can help with this concern
  • How the intervention is described, and patient expectation of outcomes can have large effects on study outcomes
  • In asthma studies, treatment outcomes for symptom control and exacerbations are often discordant
  • Short-term responses do not necessarily reflect long-term safety in asthma trials
  • Asthma symptoms are modifiable by placebo or sham treatment, but are often used as outcome measures in trials of non-pharmacological treatments
  • Example case: A pharmacist-delivered inhaler technique education intervention resulted in improved inhaler technique, asthma control and asthma-related quality of life (Basheti et al. Patient Educ Couns, 2008)
  • Example case: A double-blinded RCT trial of breathing technique exercises with shallow nasal breathing failed to improve asthma outcomes, when compared to non-specific exercises with no evidence of benefit (Slader, Thorax, 2006)
  • High quality research of non-pharmacological interventions is possible using standardised outcomes, achieving blinding where possible and considering cost-effectiveness
  • Involving patients in study concept and design can be beneficial

About Prof. Helen Reddel:living with severe asthma, Prof Helen Reddel

Prof. Reddel’s research focuses on strategies to improve the management of airways disease, and population level monitoring of asthma and COPD outcomes. She has a strong focus on improving communication between patients and health professionals, and on making guidelines not only evidence-based, but also practical and patient-centred.

She is Chair of the Science Committee of the Global Initiative for Asthma (GINA), a member of the Guidelines Committee for the Australian Asthma Handbook, and clinical adviser to the Australian Centre for Airways disease Monitoring (ACAM).

To view other webinars on Severe Asthma please click here

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