Developing Consensus on the Reporting of Patient and Public Involvement

Developing consensus on the reporting of patient and public involvement

Sophie Staniszewska & Jo Brett(RCNRI, University of Warwick)

Iveta Simera (EQUATOR, University of Oxford)

Collaborators (in alphabetical order):

Altman D (EQUATOR, Universty of Oxford), Barber R (ScHARR, Sheffield University), Cook S (British Medical Journal), Denegri S (INVOLVE), Entwistle A (UNTRAP, Warwick University) Littlejohns P (Kings College London), Mockford C ((RCNRI, University of Warwick), Moher D (Ottawa Methods Centre, Canada), Morris C (Peninsula College of Medicine and Dentistry, Seers K ((RCNRI, University of Warwick), Suleman R (UNTRAP, University of Warwick), Thomas V (NICE), Tysal C (UNTRAP, University of Warwick)

Introduction: Patient and public involvement (PPI) in health and social care research is often poorly reported in research papers, with limited or incomplete information provided. There is aneed to enhance the quality and consistency of this reporting in order to develop our understanding of what types of PPI work, for whom, why and in what context.

We have made some important steps in the right direction. GRIPP (Guidance for the reporting of Patient and Public Involvement) was developed to identify the main elements of good reporting for PPI, based on a systematic reviews of the PPI evidence base (Staniszewska 2011, Brett et al 2012, Mockford et al 2011). We arenow moving to the next stage, using GRIPP as the basis for developing consensus, or agreement on which items (or aspects of PPI) are essential to report, drawing on the expertise and experiences of researchers, service users, clinicians, funders and commissioners. This process of consensus strengthens our understanding of what should be reported.

There is currently no consensus based guidance for researchers reporting patient and public involvement. It is therefore timely to develop such guidance to assist authors in writing papers, editors and peer reviewersin reviewing manuscripts for publication, and readers in criticallyappraising published articles. We will be following EQUATOR methodology to ensure GRIPP 2 is developed using the same rigorous approach.

Aim: To develop GRIPP 2, a reporting guideline for PPI in health and social care research, through expert consensus to improve the quality and transparency for reporting of PPI in health and social care research.

Methods:The study follows standard EQUATOR methodology in the development of reporting guidance (Moher 2010, Nair 2011, Chan 2013). Your involvement will be in a three-round Delphi study that will be conducted with participants with experience in the PPI field using an online survey between OctoberandFebruary2013.

Selection of preliminary items for the guidelines:Preliminary items (aspects of PPI reporting) for the Delphi survey will include those in GRIPP 1 and will be grouped using existing groupings which follows the standard way in which a paper is organised: General information, Introduction, Methods, Administration, Analysis and Ethical considerations, Reporting and Dissemination, Other.

Each item will include a heading and a description. The wording in the first survey in phase 1 of the Delphi is broad, and our aim is to narrow down the number of items included in the final guidelines

We have ethical approval from the Humanities and Social Sciences Research Ethics Committee, the University of Warwick (HSSREC 28/11-12 (c))

Participants’ confidentiality will be ensured. Individual responses will be known only to the researcher and only amalgamated results will be publically available .

The Delphi process is reported in figure 1 below, and described under figure 1.

Phase 1: In phase 1, participants are asked to rate the GRIPP items from 1 to 10, or no opinion. A rating of 1 corresponds with unimportant and 10 corresponds to very important. Space will be provided against each item for free text comments to suggest refinements, reiterations or to suggest additional items.

Phase 2: In phase 2, participants are asked to rate the GRIPP items again, including any additional items suggested in Phase 1. No changes will be made to the items apart from the addition of newly nominated items from round 1 (drafted to include heading and description).

For each item,panellistswill have their previous rating, and will be presented with group summary ratings (medians, interquartile ranges [IQRs], and frequency distributions) and all anonymised free text comments from round 1.

Phase 3: In phase 3 results of items reaching consensus (from round 1 and round 2), and any additional feedback will be reported. Part 3 of phase 3 will include items introduced in Round 2. Part 4 & Part 5 of this phase will include items requiring a third round of feedback as they have been rated moderate importance (6≤ median ≥7) after the first two rounds of this Delphi survey. These parts will also include single items that may have had multiple concepts of differing importance identified.

Post Delphi: Generate a list of items The three round Delphi consensus exercise will be used to generate the items for the next version of the GRIPP checklist. If there are a large number of items at this stage, the items may be reduced by consensus within the research team to make them manageable for discussion at a consensus face-to-face meeting.

If you are not sure of the stages, please email:

Jo Brett:

Sophie Staniszewska: Sophie

References:

Brett J, Staniszewska S et al (2012). Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expectations.19 JUL 2012.

Mockford C,Staniszewska S. Griffiths F, and Herron-Marx S (2011). The impact of patient and public involvement (PPI) on UK NHS healthcare: a systematic review. International Journal for Quality in Health Care, (1353-4505)

Staniszewska S, Brett J, Mockford C, Barber R (2011). The GRIPP checklist: Strengthening the quality and transparency of reporting for patient and public involvement in research. International Journal of Technology Assessment for Health Care, 27 (4):391-399.

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG, for the CONSORT Group. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trial. BMJ. 2010;340:c869

Nair R, Aggarwal R, Khanna D. Methods of Formal Consensus in Classification/Diagnostic. Criteria and Guideline Development. Arthritis Rheum 2011 41:95-105

Chan AW, Tetzlaff J; Altman D, Laupacis A, Gøtzsche P et alSPIRIT 2013 Statement: Defining Standard Protocol Items forClinical Trials Research and Reporting Methods Annals of Internal MedicineAnn Intern Med. 2013;158:200-207