Background There is an increasing international interest in patient and public involvement (PPI) in research, yet relatively little robust evidence exists about its impact on health and social care research.

GRIPP2 (short form and long form) is the first international guidance for reporting of patient and public involvement in health and social care research. This paper describes the development of the GRIPP2 reporting checklists, which aim to improve the quality, transparency, and consistency of the international patient and public involvement (PPI) evidence base, to ensure that PPI practice is based on the best evidence

This is the first international systematic review to focus on the impact of PPI on the people involved in the process. The beneficial and challenging impacts reported highlight the importance of optimising the context and processes of involvement, so creating the potential for PPI to impact positively on the research itself.

BackgroundWhile the patient and public involvement (PPI) evidence base has expanded over the past decade, the quality of reporting within papers is often inconsistent, limiting our understanding of how it works, in what context, for whom, and why.ObjectiveTo develop international consensus on the key items to report to enhance the quality, transparency, and consistency of the PPI evidence base. To collaboratively involve patients as research partners at all stages in the development of GRIPP2.MethodsThe EQUATOR method for developing reporting guidelines was used. The original GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklist was revised, based on updated systematic review evidence. A three round Delphi survey was used to develop consensus on items to be included in the guideline. A subsequent face-to-face meeting produced agreement on items not reaching consensus during the Delphi process.ResultsOne hundred forty-three participants agreed to participate in round one, with an 86% (123/143) response for round two and a 78% (112/143) response for round three. The Delphi survey identified the need for long form (LF) and short form (SF) versions. GRIPP2-LF includes 34 items on aims, definitions, concepts and theory, methods, stages and nature of involvement, context, capture or measurement of impact, outcomes, economic assessment, and reflections and is suitable for studies where the main focus is PPI. GRIPP2-SF includes five items on aims, methods, results, outcomes, and critical perspective and is suitable for studies where PPI is a secondary focus.ConclusionsGRIPP2-LF and GRIPP2-SF represent the first international evidence based, consensus informed guidance for reporting patient and public involvement in research. Both versions of GRIPP2 aim to improve the quality, transparency, and consistency of the international PPI evidence base, to ensure PPI practice is based on the best evidence. In order to encourage its wide dissemination this article is freely accessible on The BMJ and Research Involvement and Engagement journal websites.Electronic supplementary materialThe online version of this article (doi:10.1186/s40900-017-0062-2) contains supplementary material, which is available to authorized users.

Objectives:The aim of this study was to develop the GRIPP (Guidance for Reporting Involvement of Patients and Public) checklist to enhance the quality of PPI reporting. Methods: Thematic analysis was used to synthesize key issues relating to patient and public involvement (PPI) identified in the PIRICOM and PAPIRIS systematic reviews. These issues informed the development of the GRIPP checklist. Results: The key issues identified included limited conceptualization of PPI, poor quality of methods reporting, unclear content validity of studies, poor reporting of context and process, enormous variability in the way impact is reported, little formal evaluation of the quality of involvement, limited focus on negative impacts, and little robust measurement of impact. The GRIPP checklist addresses these key issues. Conclusion:The reporting of patient and public involvement in health research needs significant enhancement. The GRIPP checklist represents the first international attempt to enhance the quality of PPI reporting. Better reporting will strengthen the PPI evidence-base and so enable more effective evaluation of what PPI works, for whom, in what circumstances and why.Keywords: Patient and public involvement (PPI), Impact, Checklist, Reporting, Quality Patient and public involvement (PPI) in Health Technology Assessment (HTA) and health research has become increasingly common internationally. Interest and activity have grown, with projects in the European Union, Australia, Canada, and other countries focusing on different aspects of PPI (1;3;6;11;14;18;20;21;24). There is a general agreement on the need for more patient-focused HTA methodsWe would like to acknowledge the contribution of the research teams and advising groups for PIRICOM and PAPIRIS to these two original reviews. The PIRICOM systematic review was funded by the United Kingdom Clinical Research Collaboration. The PAPIRIS systematic review was funded by the National Centre for Involvement, UK. and several HTA agencies and HTA researchers are reviewing ways to incorporate the patients' or, more generally, the public's perspectives into their methods (9). However, the need for evidence through robust evaluation has also been emphasized to convince a broader constituency of the HTA community about the impacts of PPI (10;22). In the United Kingdom, the Director General of NHS Research and Chief Medical Officer has recently stated that involvement should be the norm, not the exception, in health research (including HTA), although progress is still needed to implement this vision. The overall aims of involvement are to enhance the quality, relevance, and appropriateness of research and also to contribute to the broader democratization of research, through participatory forms of involvement that encourage partnership in research (4,6). Within the United Kingdom, considerable effort has been focused on developing an infrastructure to operationalize the policy commitment to PPI, through the work of organizations such as INVOLVE (12) and the Research Design...

Concerns have been raised regarding the possible negative psychological impact of the cancer screening programmes offered in the UK. This review aims to assess the extent of and factors associated with the adverse psychological consequences of mammographic screening. Fifty-four papers from 13 countries were identified, a majority of which were published after 1990, coinciding more or less with the onset of routine mammographic screening. The results report that mammographic screening does not appear to create anxiety in women who are given a clear result after a mammogram and are subsequently placed on routine recall. However, women who have further investigations following their routine mammogram experience significant anxiety in the short term, and possibly in the long term. The nature and extent of the further investigation that women are exposed to during mammographic screening determines the intensity of the psychological impact. Factors associated with the adverse psychological impact of mammographic screening included: social demographic factors of younger age, lower education, living in urban areas, manual occupation, and one or no children; cancer screening factors of dissatisfaction with information and communication during screening process, waiting time between recall letter and recall appointment, pain experienced during the mammographic screening procedures, and previous false positive result; and cancer worry factors including fear of cancer and greater perceived risk of breast cancer. Difficulties in measuring the psychological impact of screening are discussed, and methods of alleviating the negative psychological outcomes are suggested.

Despite having received a final clear result during their previous routine breast screening 3 years ago, women who had undergone FNA, surgical biopsy or been placed on early recall suffered significantly greater adverse psychological consequences at 1 month before their next routine breast screening appointment than women who had received a clear result after their initial mammogram at their last routine breast screening. Having undergone further investigations did not necessarily motivate women to attend for their next routine appointment, with 15 per cent of these women not returning for routine screening 3 years on.

While patient and public involvement (PPI) in health and social care research has progressed successfully in the last decade, a range of difficulties with the evidence base exist, including poor understanding of the concept of impact, limited theorization and an absence of quantitative impact measurement. In this paper, we argue that a paradigm change towards robust measurement of the impact of involvement in research is needed to complement qualitative explorations. We argue that service users should be collaboratively involved in the conceptualization, theorization and development of instruments to measure PPI impact. We consider the key advantages measurement would bring in strengthening the PPI evidence base through a greater understanding of what works, for whom, in what circumstances and why.