BACKGROUND AND OBJECTIVES:Coproduction in evidence synthesis is increasingly recognized as essential for developing meaningful evidence for decision-making. However, little is known about when, how, and whom to involve, and no clear research agenda exists to guide which methodological aspects of coproduction should be prioritized. This study aimed to identify and prioritize research topics through a rigorous process. STUDY DESIGN AND SETTING:We conducted a multi-phase Delphi process to achieve agreement on methodological research priorities. We generated research ideas from a coproduction workshop, a widely rolled out survey, and a review of methodological papers. We qualitatively analyzed and synthesized these ideas into broad topics, each presented with explanations and examples. People representing relevant key interest-holder groups in evidence synthesis, namely (1) experts in coproduction , (2) health professionals, (3) patients/carers/public, (4) policymakers, and (5) researchers, rated topics over two Delphi rounds using a seven-point Likert scale (1 = of least importance; 7 = of greatest importance). We weighted results to address under-representation of interest-holders and visualized group results. RESULTS:Starting with an interim list of 47 research ideas, we incorporated 86 contributions from 141 survey participants and 109 research needs from 28 methodological research papers. This process yielded 242 items that we grouped into 31 distinct topics. The Delphi process involved 58 participants in round 1, 52 in round 2, and 48 in the final round, with participation of all interest-holder groups. Participants were from 21 countries across all continents. In the final round, 98% of participants agreed on the weighted, final list of the top 20 research priorities, with the highest ranked topics being methodological research relating to (1) engagement of diverse co-producers, (2) best practice standards for engagement/involvement, (3) power dynamics, (4) communication and relationship with co-producers, and (5) impact of coproduction on the evidence synthesis. CONCLUSION:Our study establishes a clear research agenda for researchers, policymakers, and funders. These priorities should inform future efforts for advancing methods of coproduction in evidence synthesis. PLAIN LANGUAGE SUMMARY:Evidence synthesis is the process of bringing together information from multiple studies to provide a clearer understanding of what is known about a specific topic. Research of co-production means that research teams and people with an interest in the topic such as patients/carers/public, health-care professionals, policymakers, and many more work together to plan, conduct, and publish research that is relevant and useful. There is currently little known about how best to achieve useful and impactful coproduction for evidence synthesis. In this study, we gathered ideas about possible research to improve coproduction in evidence synthesis from a range of people. We then had a series of online voting, using recognized methods to help reach agreement. We used analysis methods designed to give all groups of people an equal voice in the voting process. We gathered 242 ideas which we grouped into 31 topics. In total, 58 people from 21 countries voted on these. The process identified the shared top 20 research priorities.

Background Green health prescribing (GHP) refers to nature-based interventions (NBIs) prescribed by a clinician or qualified health or social care professional. Given the ageing global population and increasing care needs posing severe challenges for healthcare systems, green health prescribing has emerged as a potentially effective and efficient to support healthy ageing in older people living with long-term conditions. This evidence review aimed to identify the barriers and enablers to access, uptake, implementation and delivery of NBIs Methods We undertook a systematic review of qualitative evidence exploring the barriers and enablers of green health prescribing and engagement with nature-based interventions. Searches from 2000 up to October 2024 were conducted in Medline, PsycINFO, ASSIA (Applied Social Sciences Index and Abstracts), GreenFILE, Web of Science and Dimensions and Overton and Google for grey literature. Study selection (based on a priori -defined eligibility criteria), data extraction, and quality appraisal were conducted independently by two reviewers and discrepancies were resolved by a third reviewer. Qualitative data were extracted from each article, and we conducted an inductive thematic synthesis of data. We followed reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), the Enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) and GRIPP2 for patient and public involvement and engagement (PPI-E) Results Ten overarching factors were identified from 27 included studies representing barriers and enablers of access to or implementation of green health prescribing and nature-based interventions. Key barriers included challenges in programme accessibility, gaps in service provision and healthcare professionals’ knowledge, prescriber hesitancy, limited organisational capacity, socioeconomic disparities, and limited evidence of effectiveness. Conversely, enablers included accessibility of green spaces, positive experiences in social engagement and connecting to nature and provider’s enthusiasm and commitment. Conclusions Our findings explore factors that can directly influence access and engagement of older people with NBIs, and organisational capacity of service providers and prescribers. To realise the full potential of green health prescribing in supporting healthy ageing and reducing health inequalities, future efforts should prioritise accessible programme design, invest in community provision infrastructure, and improve the integration within primary and community care settings. Systematic review registration CRD42025603199

Co-design is a collaborative process spanning the lifecycle of a design project that uses creativity, reflexivity, and iterative learning to support feedback, adaptation, and shared understanding during intervention development. Co-design aims to involve diverse groups, including patients, caregivers, clinicians, administrators, community members, researchers, designers, and policy actors. Evidence suggests co-designed interventions may be more engaging, acceptable, and feasible to implement than those developed using traditional approaches. Despite the growing adoption of co-design, considerable variation remains in how it is understood, implemented, and reported, limiting its potential to support meaningful and equitable improvements in health interventions. To map the scope and nature of the literature describing the models, theories, and frameworks (MTFs) used to co-design complex health interventions and synthesize their key characteristics. This review constitutes Phase 1 of the Preferred Components for Co-design in Research (PRECISE) initiative, which aims to enhance conceptual clarity, methodological rigour, and transparency in reporting co-design studies for complex health interventions. A scoping review was conducted following JBI guidance and reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Seven databases were searched from 1972 to 19 October 2023. Screening and data extraction were done independently and in duplicate. Publications were eligible if they reported co-design, co-production, or co-creation approaches and applied a model, theory, or framework to guide co-design of complex interventions. Extracted data were synthesized descriptively using counts and proportions. A total of 130 publications were included. Co-design terminology use was inconsistent: 62.3% of publications used the term “co-design,” 7.7% “co-production”, 6.9% “co-creation”, and 16.2% did not use any co-approach term in their methodology. Among publications using a co-approach term, only 31.2% provided an associated citation. Fewer than two-thirds (60.0%) reported reciprocal collaboration with co-design partners. Among these, “developing the intervention” was the most commonly reported role (89.5%), while involvement in analysis and dissemination was less frequently reported. Reported co-design principles were variable, with "use participatory means" being the most prevalent (93.9%). Regarding MTFs, 70.0% of publications used a design-only MTF (e.g., pre-2021 Medical Research Council framework). Only three studies (2.3%) used a co-only MTF. Nearly half (42.3%) reported using a co + design MTF (e.g., Double Diamond). Of those using a co + design MTF, 67.3% operationalized its elements in the study context. This scoping review reveals significant variability in how co-design is defined, conceptualized, and applied in the development of complex health interventions, with limited use of and application of MTFs. These findings highlight the necessity for clearer conceptual bases and more transparent reporting. As Phase 1 of the PRECISE guideline initiative, this review lays the empirical groundwork for developing reporting standards for co-design research. The Open Science Framework on June 12, 2023 (osf.io/prd3t).

La participación de pacientes y ciudadanos en la investigación contribuye a mejorar la relevancia de los estudios, aunque su presentación en la literatura es inconsistente y poco clara. Para mejorar la transparencia y la calidad de esta participación se desarrollaron las guías GRIPP2 (Guidance for Reporting Involvement of Patients and the Public), que ofrecen orientación específica para una presentación sistemática y transparente. Esta nota metodológica describe la adaptación y traducción al español de dichas guías, con el objetivo de fomentar la calidad, la coherencia y la transparencia en la evidencia sobre la participación de pacientes y ciudadanos en la investigación. Se presentan dos versiones: GRIPP2 formulario largo, con 34 ítems orientados a estudios en los que la participación de pacientes y ciudadanos es el foco principal, y GRIPP2 formulario corto, con 5 ítems para estudios en los que esta participación es un componente secundario. Las guías están dirigidas fundamentalmente a investigadores y autores que quieran incorporar la participación de pacientes y ciudadanos en sus investigaciones, así como a revisores y editores de revistas. Además, también pueden ser de interés para responsables de políticas de investigación, agencias financiadoras, agencias de evaluación de tecnologías sanitarias y, por supuesto, pacientes y ciudadanos.

Background There is growing attention on research and intervention prioritization regarding the social determinants of health to address health inequalities. Community involvement in this prioritization is centrally important. This scoping review aimed to identify: (i) examples of priority setting regarding the social determinants of health and (ii) methods for involving local communities in research or intervention prioritization.Methods Searches were conducted in Medline, Social Policy & Practice, Applied Social Sciences Index & Abstracts, CINAHL, and Carrot2 in May 2024. Eligible studies reported prioritization with communities for interventions or research about the social determinants of health. Studies reported primary research in high-income countries. A narrative synthesis was undertaken, with a review team involving different professionals and public contributors.Results Eighteen studies were included. Community prioritization methods varied, though commonly included participatory approaches, with additional reports of Delphi exercises, a super-setting approach, a nominal group technique, a deliberative exercise using a serious game, and a modified James Lind Alliance process.Conclusions Meaningful community involvement in research and intervention prioritization offers critical opportunities to reduce existing health inequalities. Participatory and coproduced approaches are valuable to research collaborations, funders, and public health organizations, which should ensure trust, accessibility, and inclusion to involve diverse and underrepresented communities.

Objective Patient and public involvement (PPI) is an essential component of Health Technology Assessment (HTA), as it enhances the relevance and transparency of evaluation processes. Nevertheless, the scope of such involvement varies considerably across contexts, and empirical evidence on current practices within the National Health System remains limited. This study will examine the extent to which HTA reports incorporate PPI and how these practices are performed and described. Method We will conduct a cross-sectional meta-research study of HTA reports produced by the Spanish Network of HTA Agencies (RedETS) between 2020 and 2026. Eligible reports will be identified through public repositories (https://redets.sanidad.gob.es/). A random sample of 150 reports will be selected. General and methodological characteristics, and PPI reporting practices will be extracted (by at least three researchers) from each HTA report using a standardised data extraction form. Descriptive analyses will be carried out to synthesise PPI reporting practices. Study registration Open Science Framework (https://osf.io/k6e3q/).

Health economics and implementation science play a critical role in the uptake of evidence-based practice but have largely sat siloed. This paper summarises findings from a 3-day workshop on health economics and implementation science. Workshop attendees included 30 health economists, implementation scientists, patient contributors, and patient and public involvement and engagement researchers from Australia and the United Kingdom. A shared vision for moving from siloed to synergistic disciplinary approaches was derived through consensus. This article outlines to researchers and methodologists what synergistic disciplinary approaches could look like. We highlight opportunities for health economics and implementation science to integrate along the innovation pathway, from the development and evaluation of innovation to eventual uptake and spread. Greater collaboration between implementation scientists and health economists has the potential to optimise implementation strategies, provide robust evidence for value for money and ultimately improve care delivery. Stronger integration of health economics and implementation science may also shed more light on the equity impacts of implementation strategies and guide their further design to promote more equitable care and outcomes.

Pathogen genomics is increasingly used in publicly funded studies and has important implications for understanding infectious diseases and their spread. However, unlike many other research areas, it has seen little patient and public involvement (PPI), thereby missing opportunities to enhance both research processes and outcomes. This project addressed that gap by exploring the potential contribution of PPI to pathogen genomics, using whole-genome sequencing (WGS) data visualisation as an exemplar. Following ethical approvals, three 2 h PPI workshops involving five public contributors and six academic contributors were held online. Sessions were documented using visual meeting notes. Workshops were audio-recorded, transcribed and analysed using an iterative thematic analysis. Two interconnected themes were identified. First, effective public involvement required collaborative sense-making, achieved through co-producing a shared knowledge base, establishing consistent terminology and developing effective practices for knowledge exchange. Second, participants highlighted three priority areas for meaningful PPI in future pathogen genomics research: (i) prioritising research questions, (ii) contributing to decisions about data collection and use and (iii) supporting the communication of findings. Although pathogen genomics is technically complex, this did not prevent productive discussion about how, where and why PPI could be integrated into research. Expanding PPI in this area could help align pathogen WGS research with patient priorities, inform approaches to data governance and improve the accessibility of research outputs to the public. Realising this potential, however, will require active engagement from researchers in the field.

Introduction Patient and public involvement (PPI) in research is increasingly recognised for its potential to enhance feasibility, improve relevance and foster collaboration at different stages of a study. Reporting guidelines such as GRIPP2 (Guidance for Reporting Involvement of Patients and the Public) have been developed to help improve completeness and transparency in PPI reporting. This meta-research project aims to assess the impact of the GRIPP2 reporting guidelines through citation and alternative metrics, analysing its uptake or adoption across authors, institutions, journals and countries, as well as its practical application in reporting PPI within diverse research designs.Methods and analysis This protocol for a meta-research project consists of two studies. In Study 1, we will conduct a search across Web of Science, Scopus and Google Scholar to identify all publications citing the GRIPP2 guidelines (planned for July 2026 using forward citation analysis). Retrieved records will undergo standardised processing and structured de-duplication to ensure each citing article is represented once. Following de-duplication, data from unique citations—including title, publication year, journal, subject category, keywords, document type, citations, authors’ names, institutional affiliations, country and funding sources—will be collected. Citation counts, alternative metrics (eg, mentions in policy documents, news media) and knowledge production patterns across authors, institutions, journals and countries will be analysed to assess GRIPP2’s impact and uptake of the guidelines. Descriptive analyses will be conducted (including the number of papers, citations, authors, countries, journals, keywords, funding, field distribution and main collaboration metrics). Network analyses will be carried out to study the structure of collaborations. In Study 2, we will evaluate a random sample of 300 research articles citing GRIPP2, including randomised trials (n=100), systematic reviews with meta-analyses (n=100) and health economic evaluations (n=100). If an insufficient number of citing studies are available within these categories, we will include additional study types identified in Study 1 (eg, study protocols, observational studies, mixed-methods or qualitative research studies and other types of reviews). Reporting and PPI practices in each article will be extracted by at least two researchers using a standardised data extraction form. Information on general, methodological and PPI items will be analysed and reported, stratified by study design (eg, randomised trials vs systematic reviews vs health economic evaluations).Ethics and dissemination Due to the nature of the proposed study, no ethical approval will be required. All data will be deposited in a cross-disciplinary public repository. It is anticipated the study findings could be relevant to a variety of audiences. Study findings will be disseminated at scientific conferences and published in peer-reviewed journals.Trial registration number Open Science Framework: https://osf.io/et85d

Patient and public involvement in research contributes to improving the relevance of studies, although its reporting in the literature is inconsistent and lacks clarity. To enhance the transparency and quality of this involvement, the GRIPP2 (Guidance for Reporting Involvement of Patients and the Public) guidelines were developed, providing specific guidance for systematic and transparent reporting. This methodological note describes the adaptation and translation of these guidelines into Spanish, with the aim of promoting quality, consistency, and transparency in the evidence on patient and public involvement in research. Two versions are presented: GRIPP2 long form, with 34 items aimed at studies where patient and public involvement is the primary focus, and GRIPP2 short form, with 5 items for studies where involvement is a secondary component. The guidelines are primarily intended for researchers and authors wishing to incorporate patient and public involvement in their research, as well as for reviewers and journal editors. Additionally, they may be of interest to research policy makers, funding agencies, health technology assessment bodies, and, of course, patients and the public.

BACKGROUND:People from Black African Diaspora Communities (BAFDC) experience poorer health outcomes and are persistently under-represented in health and care research. There is limited understanding about how to support their greater inclusion and participation. OBJECTIVES:Explore secondary data providing insights for the co-development of a realist theory of inclusion and participation for people from BAFDC in health and care research in the United Kingdom. Drawing on these theories, co-produce a realist review with a diverse range of people from BAFDC. METHODS:A realist approach underpinned the study. Pawson's five steps to a realist approach were taken to shape the review, identify relevant sources, extract the data and then analyse and synthesise to inform an overarching programme theory. Initial programme theories (IPTs) were developed through context (C), mechanism (M), outcome (O) configurations (CMOCs). MAIN RESULTS:The review identified 43 relevant documents. Synthesis of evidence from the documents resulted in 8 IPTs and 17 CMOCs helping to understand and explain the inclusion and participation of people from BAFDC. Four key thematic clusters emerged: (1) Health and care research as a White space, (2) Trust deficit: the expansiveness of broken trust, (3) Implicit and complicit bias and (4) Processes that affect inclusion and participation. Findings were underpinned by five existing mid-range theories (MRTs) around central concepts of candidacy, social dominance, networks, narratives and racism that guided analysis and synthesis, supporting conceptualisation of CMOCs. An overarching programme theory was developed. CONCLUSION:The review identifies how the influence of perspectives, attitudes and beliefs held by individuals or groups about people from BAFDC operates in health and care research, resulting in exclusion, lack of trust and deficit thinking. The findings should be used to inform interventions aimed at increasing inclusion and participation of people from BAFDC. PATIENT OR PUBLIC CONTRIBUTION:The co-production group comprised a diverse range of individuals from within the health and care research system with different lived experiences of being Black. They contributed to the entire review process, including the development of initial programme theories and retroductive thinking and interpretation of the evidence. CLINICAL TRIAL REGISTRATION:Not applicable.

Understanding the experiences of people who have postural orthostatic tachycardia syndrome (POTS) and the health professionals who care for them: a grounded theory study. Background Postural orthostatic tachycardia syndrome (POTS) is an under recognised, predominantly female condition. Awareness of this condition has increased due its association with Long-COVID. Understanding experiences informs areas for future study. Research into the experience of POTS is emerging, with no currently published studies including the experiences of health professionals. Aim This study aimed to understand experiences of POTS, its challenges, and aspects of care from the perspectives of people with the condition and health professionals who look after them. Design A grounded theory approach was taken to develop a conceptual framework of the experience of POTS conceptualised through a critical realist lens. Setting This United Kingdom based study included people with POTS from three national health care centres and a diverse range of health professionals. Participants Theoretical and purposive sampling recruited people with POTS, and snowball sampling recruited health professionals through a United Kingdom charity and arrhythmia nursing network. Health professionals were interviewed from a range of professions including nurses, secondary care consultants, primary care general practitioners, psychologists, physiotherapists, and an occupational therapist. Method Between September 2021 and September 2022 in-depth online semi-structured interviews were undertaken. Data were thematically analysed. Corbin and Strauss' Grounded Theory methods of constant comparison, memos, and a reflexive journal were used. Analysis moved from first open coding of health professional themes to more focused axial coding, data, and category linking. The study patient and public involvement group informed thematic development and theoretical sampling. The final themes were conceptualised through the critical realism's three layers of experience. Results Forty-four participants were included, 19 people with POTS and 25 health professionals. Three core themes were found: 1) A challenging condition, 2) POTS healthcare provision - services by accident not design, and 3) The need to validate experiences. Health professionals experienced challenges in their clinical self-efficacy. POTS care was driven by individual human agency and interpersonal relationships. People with POTS took individual responsibility for their self-management but were impacted by gender inequalities, a medical model prioritising guidelines, and a poor evidence-base. Conclusion This is the first qualitative study to explore both people with POTS and health professional experiences of looking after people with this condition. Findings identified: 1) a need for empowering both people with POTS and health professionals through shared care and decision making, 2) the requirement for a system wide recognition of POTS to move the landscape away from one of individual responsibility, and 3) the need to develop the evidence-base. Registration Health Research Authority (IRAS: 281284). First recruitment: 13/09/2021. Tweetable abstract Understanding the experiences of people with POTS and the health professionals who see them. The findings of 44 in-depth interviews.

BACKGROUND:Stillbirth, second-trimester miscarriage and recurrent miscarriage carry significant consequences for women. We lack sufficient high-quality evidence of interventions to improve a woman's health and subsequent pregnancy outcomes after discharge to the community. OBJECTIVE:Assess the effectiveness of interventions to improve general health and subsequent pregnancy outcomes for non-pregnant women who have had a stillbirth, second trimester miscarriage, or recurrent miscarriage. SEARCH STRATEGY:Database searches were undertaken in August 2022 (updated March 2024) and limited to full-text documents published from 1995. SELECTION CRITERIA:Interventions delivered after discharge for non-pregnant women following a pregnancy loss. DATA COLLECTION AND ANALYSIS:Screening was performed independently by two reviewers; narrative synthesis was undertaken. Risk of bias was assessed by RoB-2, ROBINS-I or the Mixed Methods Appraisal Tool. MAIN RESULTS:A total of 18 603 abstracts screened; 196 full texts assessed and 15 papers included. The quality of evidence was low, and the primary aim of the review was not met due to limited evidence. All included studies aimed to improve mental health. No studies were identified that aimed to improve the physical health of women or subsequent pregnancy outcomes. CONCLUSIONS:There is a significant evidence gap regarding how best to care for women who experience pregnancy loss after discharge to the community. There is an urgent need for research to determine which interventions are most effective to improve a woman's short- and long-term health and subsequent pregnancy outcomes following a stillbirth, second-trimester miscarriage or recurrent miscarriage. TRIAL REGISTRATION:PROSPERO Registration: CRD42022360264.

Background: In-person data collection has long been considered the ‘gold standard’ for qualitative data collection. Societal changes and the rapid increase in the use of remote methods during the Covid-19 pandemic intensified debate about the limitations and opportunities of remote data collection, while reigniting questions about data quality and inclusion. Objective: We sought to map available evidence exploring the characteristics and quality of remotely collected qualitative data compared to in-person qualitative data. Eligibility Criteria: A scoping review was conducted of empirical research studies that employed both remote and in-person methods with similar participants, to address the same research question. Sources of Evidence: Searches were conducted in MEDLINE, CINHAL, Web of Science, Scopus and Applied Social Science Index and Abstracts (ASSIA). The review includes peer reviewed articles published in English since 2000. Methods: Data were extracted from included papers using a data extraction tool based on JBI guidance, adapted to address our research questions. Results: A total of 58 articles are included. These cover a range of research methods and participant groups. Overall, remotely collected data is likely to generate similar themes to data collected in person but more concisely. Sensitive topics may be the exception. Non-verbal data and interaction between participants may be lost but the significance of this for data quality is not as well understood as participants may disclose more information remotely. Conclusions: Researchers should consider the fit of epistemology, population and topic when making decisions about remote data collection. If the benefits of remote data collection for qualitative research are to be fully realised, further research is needed to identify which elements of in-person and remote qualitative data collection are most effective, with which populations and research topics, and how remote data differs from in-person data.

Objectives There is a paucity of qualitative research exploring the patient experience of living with a meniscal tear, vital to effective patient management. The aim of this study was to explore the experiences and expectations of treatment of patients aged 18-55 years with a meniscal tear of the knee.Design Qualitative study involving semistructured interviews.Setting Participants were selected from nine secondary care centres in England.Participants 10 participants diagnosed with a meniscal tear were recruited from the Meniscal Tear Outcome cohort study using a purposive sampling strategy until data saturation was achieved. Semistructured interviews were conducted between April and May 2021 and thematic analysis was used to identify key patient experiences.Results Themes identified relate to the broad areas of symptoms, clinical consultation and experience of treatment. Meniscal tears have a profound impact on pain and many patients experience effects on their family and financial life in addition to physical symptoms. Participants expected most of their management to occur in secondary care and most thought surgery would be a definitive treatment, while they believed the effectiveness of physiotherapy could not be guaranteed as it would not fix the physical tear.Conclusion This study is one of the first to explore patient experiences of a meniscal tear and their perceptions of treatment options. Patient experiences and perceptions are important for clinicians to understand in order to provide the best possible care. It is important to elicit these experiences, listen to the patient, discuss their perspectives and build these experiences and expectations into clinical care.Trial registration number ISRCTN11534691.

The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Herein, we systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (harms, outcomes, nonpharmacological treatment) and other reporting guidelines (Template for Intervention Description and Replication [TIDieR]). The potential modifications were rated in a 3-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of 2 new protocol items, revision to 5 items, deletion/merger of 5 items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open-science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policy makers, regulators, and other reviewers.

While patients and the public are routinely involved as active collaborators in health and social care research, they are rarely involved in the implementation of research. The PIPER (Pathways to Implementation for Public Engagement in Research) research questions are: 1. How can patients, carers, service users and the public be involved in the implementation of health and social care research evidence into practice? 2. What types of roles, contributions and impact can patients, carers, service users and the public make to the implementation of health and social care evidence into practice? 3. How can we support patients, service users, carers and the public to contribute to the implementation of health and social care evidence into practice? 4. How can we co-produce the knowledge that explores a greater role for patients, carers, service users and the public in the implementation of health and social care evidence into practice? Our overarching methodological framework is realist evaluation. This study includes four work packages with a cross-cutting co-production theme. •Work Package 1: A realist review of published literature, grey literature and sources such as blogs. •Work Package 2: Interviews with 40–60 people using a realist approach. •Work Package 3: A series of workshops to co-design the PIPER Toolkit. •Work Package 4: Pilot evaluation of the PIPER Toolkit. The scoping of the literature will be informed by the development of an initial programme theory that identifies the potential breadth of the field of public involvement in implementation. Data from the WP2 interviews will be used to iteratively refine the development of the context, mechanism and outcomes (CMOs). This will inform the PIPER Toolkit, which will consist of a set of ‘Guiding Principles’ supported by ‘Practical Resources.’ The PIPER Toolkit will enable an individual or a group to plan and undertake implementation activities. More specifically, the Guiding Principles will enable the Practical Resources to be tailored to specific implementation strategies for an individual or group. Patient and public involvement in implementation is an emerging area of practice and is likely to significantly strengthen over the next decade. The PIPER Toolkit will recognise this early stage of development, identifying the key system enablers that organisations need to have in place to support this activity. The Toolkit will support patients and the public and implementation teams to navigate the field of implementation practice. The PIPER study will challenge the field of implementation and knowledge mobilisation research to develop clearer forms of partnership with patients and the public in both research and practice. Why are we doing this study? Patients and the public are often involved in research studies about health and social care, contributing to how research is designed, conducted and shared. However, they are rarely involved in moving the research evidence into practice. This is called implementation. The PIPER (Pathways to Implementation for Public Engagement in Research) research questions are: What we want to find out 1. How can patients, carers, service users and the public be involved in the implementation of health and social care research evidence into practice? 2. What types of roles, contributions and impact can patients, carers, service users and the public make to the implementation of health and social care evidence into practice? 3. How can we support patients, service users, carers and the public to contribute to the implementation of health and social care evidence into practice? 4. How can we co-produce the knowledge that explores a greater role for patients, carers, service users and the public in the implementation of health and social care evidence into practice? What we plan to do We plan to use a research approach (realist evaluation) that focuses on finding out what works, for whom, why and in what way, in four work packages: •Work Package 1: We will review relevant research and sources of knowledge including both peer-reviewed and grey literature. •Work Package 2: We will interview 40-60 people with either experience of or interest in PPIE in implementation. •Work Package 3: We will use a series of workshops to co-design the PIPER Toolkit, a set of resources, which will help with PPIE in implementation. •Work Package 4: We will pilot the PIPER Toolkit to make sure it works. The initial review of literature helped early mapping to identify the potential breadth of the field of public involvement in implementation. This will inform the PIPER Toolkit. PIPER will consist of a set of ‘Guiding Principles’ supported by ‘Practical Resources’ that will help an individual or a group to get involved in implementation activity. What we aim to achieve Patient and public involvement in implementation, rather than in research is new and is likely to evolve in the future. The PIPER Toolkit will support patients and the public who wish to be involved in implementation and individuals who are involved in moving research findings into practice. It will also help organisations understand what needs to be in place to support patient and public involvement in implementation.