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Patient and Public Involvement and its Vital Role in the Tandem COPD Study: A Randomised Controlled Trial

| Respiratory
Authors:
Amy Barradell,1 *Ratna Sohanpal2
Disclosure:

The authors have declared no conflicts of interest.

Acknowledgements:

The authors would like to acknowledge their patient and carer advisors for their support and contribution made to the study.

Support:

Research was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme 13/146/02. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health.

Citation
EMJ Respir. ;5[1]:56-58. Abstract Review No. AR3.

Each article is made available under the terms of the .

Chronic obstructive pulmonary disease (COPD) is a progressive, irreversible condition, characterised by symptoms of breathlessness, cough, sputum production, and fatigue; additionally, many patients suffer from anxiety and depression.1,2 Anxiety can range from 10–50%3 of patients; furthermore, people with severe COPD are 2.5-times more likely to develop depression compared to those with mild disease.4 These comorbidities are associated with increased likelihood of exacerbations, more frequent and longer hospital admissions, and poor quality of life.5,6 Pulmonary rehabilitation is an effective and cost-effective, but underutilised, treatment to reduce the burden of COPD.7,8

TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD) is a UK multicentre randomised controlled study evaluating the effectiveness and cost-effectiveness of a cognitive behavioural approach intervention, that links and optimises the benefits of routine pulmonary rehabilitation, with the aim of reducing mild-to-moderate anxiety and/or depression in people with COPD.

Patient and public involvement (PPI) is when research is carried out with, or by, members of the public rather than ‘to’, ‘about’, or ‘for’ them.9 In the UK, PPI is mandated in publicly funded research in order to make studies more effective and credible.10 The aim of PPI in TANDEM was to involve patients with COPD and carers in the design and implementation of the study to improve the relevance and overall quality of the research.

METHODS

Potential advisors were identified via established patient networks and through promotion of TANDEM on social media outlets. Those who expressed interest were volunteer lung support groups affiliated to the British Lung Foundation (BLF) and a dedicated hospital-based PPI committee in Greater London and Leicestershire, UK. Prior to their engagement in the study, patients were given a brief presentation about the study and what it might involve. In the first 14 months we spent a total of 10.5 days on PPI activities.

RESULTS

PPI advisors (N=59) belong to two volunteer lung support groups, two exercise groups for patients with lung disease, and one dedicated PPI group. Advice was sought in groups or individually for different aspects of the research process.

Before the Study

  • Invited to join the study steering group
  • Invited to comment on a lay summary on the proposed research design, intervention, and terminology for the funding application

During the Study

  • Provided advice on the personal and clear language used to describe the study and the design of the study leaflets used for study promotion among potential participants. Incorporating the words ‘chronic bronchitis’ and ‘emphysema’ in addition to COPD was suggested, as these are more recognisable terms, and replacing the description ‘psychological therapy’ with ‘one-to-one sessions with a healthcare professional’ was advised
  • Assisted in planning the duration, frequency, and location of intervention delivery and provided examples for patient hand-outs on the meaning of anxiety and depression
  • Piloted the outcome data collection. It was found that the average time to complete the study questionnaire was 35 minutes, and it was not burdensome to complete

The attendees at the European Respiratory Society (ERS) congress gave positive feedback regarding the visualised representation of how and where PPI activity was utilised in the study.

CONCLUSION/REFLECTION

Our PPI advisors contributed significantly to the design and implementation of the TANDEM study. The advisors will continue to be involved until study completion and results dissemination. Experiences at the ERS congress demonstrated that attendees recognised the importance and value of embedding PPI in research. Published PPI reporting checklists10 may help researchers to design PPI for a study or to assess the use of PPI in their study.

References
National Collaborating Centre for Chronic Conditions; Chronic obstructive pulmonary disease. National clinical guideline on management of chronic obstructive pulmonary disease in adults in primary and secondary care. Appendix D: Economics costs of COPD to the NHS. Thorax. 2004;59(Suppl 1):i192-4. Cassidy S et al. Attendance at pulmonary rehabilitation classes: An exploration of demographic, physiological and psychological factors that predict completion of treatment. Chron Respir Dis. 2014;11(2):95-102. Willgoss TG, Yohannes AM. Anxiety disorders in patients with COPD: a systematic review. Respir Care. 2013;58(8):858-66. Cafarella PA et al. Treatments for anxiety and depression in patients with chronic obstructive pulmonary disease: A literature review. Respirology. 2012;17(4):627-38. Ng TP et al. Depressive symptoms and chronic obstructive pulmonary disease: effect on mortality, hospital readmission, symptom burden, functional status, and quality of life. Arch Intern Med. 2007;167(1):60-7. Laurin C et al. Impact of anxiety and depression on chronic obstructive pulmonary disease exacerbation risk. Am J Respir Crit Care Med. 2012;185(9):918-23. Bolton CE et al. British Thoracic Society guideline on pulmonary rehabilitation in adults. Thorax. 2013;68(Suppl 2):ii1-30. Hogg L et al. Effectiveness, attendance, and completion of an integrated, system-wide pulmonary rehabilitation service for COPD: Prospective observational study. COPD. 2012;9(5):546-54. INVOLVE. What is public involvment in research? 2017. Available at: http://www.invo.org.uk/find-out-more/what-is-public-involvement-in-research-2/. Last accessed: 19 September 2017. Staniszewska S et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. BMJ. 2017;354:j3453.
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