Environmental enteropathy (EE) is a syndrome affecting the gut characterised by villus blunting, reduced nutrient absorption and microbial translocation in children and adults experiencing a high burden of enteric infection due to inadequate access to clean water and sanitation.

We will conduct coordinated randomised controlled trials in six countries to determine if supplementation with indispensable amino acids (IAAs) can improve intestinal barrier dysfunction in six geographically diverse populations of 18–36 months old children with stunting or severe stunting. All trials will measure the same primary outcomes while secondary outcomes will be measured on a per-trial basis using standardised protocols across the project. The primary endpoint will be change in gut permeability as assessed by the lactulose/rhamnose ratio. Secondary endpoints include changes in amino acid and carbohydrate absorption using novel, isotope tracer tests. Other prespecified outcome measures include changes in EE biomarkers and child weight. IAA supplementation will be given daily for 28 days and evaluation of the major endpoints will be at baseline and after 28 days of supplementation.

Ethical approval will be obtained from the Research Ethics Committee at each participating site. Caregivers will provide written informed consent for each participant. Findings will be disseminated through peer-reviewed journals, conference presentations and face-to-face meetings with participant caregivers.

CTRI: CTRI/2024/06/069187 (India); ClinicalTrials.gov (NCT06617130, Malawi; NCT06676215, Philippines and NCT07256028, Morocco); Ongoing (Zambia); Ongoing (Morocco); PACTR: (PACTR202311714091884, Ghana).

Research on psychosocial interventions for dementia demonstrates increased rigour and robustness. However, if we are to influence practice, beyond results from randomised controlled trials, a variety of types and sources of evidence is needed. The Medical Research Council (MRC) framework offers a valuable guide for developing, evaluating and implementing complex interventions, to facilitate integration of research into practice. There is limited knowledge of how researchers design, evaluate and implement psychosocial intervention studies in dementia, using the MRC framework. This scoping review aims to: (1) identify the methodological and methods trends, use and gaps in the development, evaluation and implementation of psychosocial interventions for dementia, and (2) determine if and how the MRC six core elements were considered and applied in studies.

Six databases (Ovid MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, Cochrane Library) will be searched for studies published from 2015 (when MRC process guidance was published) to 2025. Identified deduplicated citations will be imported into Covidence software, where up to 40% of title/abstracts will be double screened by independent reviewers. ASReview will be used to rank articles by relevance, with a stopping criterion of 250 consecutive irrelevant articles. Full texts will be reviewed by a single reviewer and those excluded will be checked by a second reviewer. Data extraction will include study aim/objective (ie, to develop/adapt; test feasibility/pilot; evaluate; implement); methodology and methods applied; information on which MRC six core elements were considered (yes/no), and if so, how they were addressed (ie, qualitative details). A narrative synthesis, alongside graphical representations (eg, table/bar charts/histograms), will be used to synthesise findings on methodologies and methods mapped onto the MRC framework.

This secondary analysis scoping review does not require ethics approval. Results will be disseminated through peer-reviewed publication(s), seminars, webinars, conferences, postgraduate dementia programmes, blogs, commissioner briefings and social media. The findings will provide a state-of-the-art overview of current practices; advance methods/methodology such as informing a Delphi consensus study on appropriate research approaches; and guide researchers in application of the MRC framework to widen the scope of dementia care evidence for practice improvements.

Submitted to Open Science Framework https://doi.org/10.17605/OSF.IO/S56NQ.

To examine the metabolic syndrome (MetS) and its components as risk factors for a cardiovascular (CV) event, in individuals without diabetes and/or hypertension, and to explore which of the risk factors are the most predictive for cardiovascular disease (CVD) and whether the assessment of risk could be simplified.

A longitudinal, cross-sectional study.

A randomly selected population.

In 2002–2005, 2816 randomly selected residents of Skaraborg, Sweden, underwent physical examinations and blood tests as part of the Skaraborg Project. Exclusion of individuals with diabetes mellitus and/or hypertension at baseline left 2328 persons for analyses.

CV events were assessed in 2011 using national Swedish registers.

A total of 293 (13%) were defined as having the MetS according to the National Cholesterol Education Programme (NCEP) and 292 according to the International Diabetes Federation (IDF) definition, whereof 27 had a CV event after a mean follow-up time of 9.7 years. The MetS according to NCEP was significantly predictive of a CVD with an HR 2.4 (95% CI 1.4 to 3.9) but not according to the IDF definition. Blood pressure was significantly predictive according to both definitions (HR 1.77, 95% CI 1.06 to 2.97). Also, triglycerides (Tg) were significantly predictive for a CV event (HR 2.05, 95% CI 1.17 to 3.59). Neither waist circumference, high-density lipoprotein nor fasting plasma glucose was predictive for a CV event. Combining a blood pressure ≥125/≥80 mm Hg with Tg ≥1.5 mmol/L was predictive for CVD (HR 2.1, 95% CI 1.3 to 3.6) with a sensitivity of 32.5% and numbers needed to examine (NNE) 7.1. Lowering the cut-off for Tg to ≥1.2 mmol/L (HR 2.1, 95% CI 1.3 to 3.4) increased sensitivity to 44.9% and NNE became 8.

Using blood pressure combined with Tg was shown to be an equally good predictor for CVD as the complete MetS in individuals without diagnosed diabetes or hypertension. Therefore, healthcare personnel should pay attention to individuals with a borderline blood pressure, and if equivalent to or equal to 125/85, continue with measuring Tg for a discussion concerning lifestyle.

To make informed health choices, and avoid waste and unnecessary suffering, people need critical thinking skills. However, like health interventions, educational interventions can have adverse effects. In this systematic review, the objective was to assess the extent to which researchers have included potential adverse effects in studies of interventions intended to improve the critical thinking of laypeople about health choices.

This study was a systematic review, in which we updated the search for an earlier systematic review of intended effects of relevant interventions. The earlier review did not address potential adverse effects. We did not update the analysis of intended effects.

We searched Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Epistemonikos, Medical Literature Analysis and Retrieval System Online (MEDLINE), Education Resources Information Center (ERIC) and Web of Science up to March 2025. In addition to studies from the original review and updated search, we included any additional studies included in a similar, even earlier review. Our unit of analysis was study report (eg, journal article).

We included all studies from the original review. We applied the same inclusion criteria to the results of the updated search: the study included a comparison, the population was laypeople and the intervention was intended to improve understanding of ≥1 key concept for informed health choices.

We extracted data about study design (randomised trial or other), participants (children, adolescents or adults), study setting (countries), main intervention (resources delivered to participants) and comparator (usual/no intervention or other). For the analysis, we extracted verbatim text describing any assessment of a potential adverse effect of the intervention. We conducted a narrative synthesis of the extracted data.

We included 35 reports of quantitative studies (including multi-method and mixed-methods studies). Most often, the study was a randomised trial, the setting was a high-income country, the population included adults (including university students) and the intervention was school-based (including university). In one of the 35 reports, authors described assessing a potential adverse effect.

To our knowledge, this is the first systematic review assessing the extent to which researchers have assessed adverse effects of any category of educational interventions. Our review shows that researchers generally have not assessed potential adverse effects of interventions to improve critical thinking about health choices. Researchers should pay more attention to such effects, while policymakers and educators making decisions about implementing relevant interventions should consider the lack of evidence. The findings of this study suggest a need for research that facilitates assessing potential adverse effects of interventions to improve critical thinking about health choices.

Partners of cancer patients often show similar levels of distress like the oncological patients themselves, and they are a primary resource for the patient’s physical and emotional support. Integrating self-care in daily routines is applied as a treatment approach in cognitive behavioural therapy. Carrying out self-care in caring relatives prevents anxiety and depression, enhances health-related quality of life and reduces caregiver burden. So far, there is no instrument which assesses self-care specifically in partners of cancer patients. The aim of this prospective mixed-methods validation study is to develop and psychometrically evaluate a psychological self-reported questionnaire assessing self-care in partners of cancer patients (SC-PC questionnaire).

Recruitment of participants will take place online and offline across Germany, Austria and Switzerland. The data collection will be carried out via personal cognitive qualitative interviews and a web-based data assessment tool within four phases: (1) personal qualitative semi-structured interviews with n15 partners of cancer patients on self-care in different areas of life; (2) pretest of derived self-care items concerning feasibility, comprehensibility and completeness with n=3–5 (psycho-)oncological experts and n=20–30 partners of cancer patients; (3) pilot study with an exploratory factor analysis with n=300 partners of cancer patients, based on an expected initial item pool of approximately 30 items and a 10:1 item-participant ratio; and (4) main validation study with confirmatory factor analysis with n=400 partners of cancer patients, based on an expected final item pool of approximately 20 items and a 20:1 item-participant ratio. Subgroup analyses will be calculated with demographic and medical variables.

A project-specific concept for data protection was established. All legal and professional regulations will be complied with. In order to meet ethical standards and protect participants from potential emotional burdens during this mainly decentralised study, ethical guidelines for online studies were implemented in the study design. The study was approved by the ethics committee of the University of Ulm (number/ID of the approval: 230/25). Results will be presented at conferences and published in scientific peer-reviewed journals for broad reach. The resulting self-care questionnaire may be implemented as a new measurement instrument in research projects investigating psycho-oncological interventions for partners of cancer patients and the practical field of cancer counselling for progress assessment.

DRKS00038519.

With a prevalence of around 7.6%, developmental language disorders (DLDs) without comorbidities are among the most common and most frequently treated childhood disorders. Standard DLD therapy in Germany consists of individual therapy sessions once per week within speech–language therapy practices. In reality, these sessions only take place every 10–14 days on average. Online therapy may be beneficial but is not yet standard practice in Germany. Although DLD group therapy has been proven to be effective, it is rarely undertaken in Germany. The aim of this study is to compare the effectiveness of online DLD therapy for small groups of children with standard one-to-one therapy.

The effectiveness of two treatment settings is evaluated in 212 children with moderate-to-severe DLD (ages 3 years to 6 years 11 months) in the multicentre, block randomised controlled trial (RCT) THErapy ONline. Five centres in Germany participate. Children are randomly assigned to the intervention group (online interval-intensive therapy, IG1, n=106) or the control group (extensive standard in-person therapy, IG2, n=106). A speech and language assessment is conducted at baseline (study entry, T0), 12 months (T1) and 18 months (T2) after therapy start. The co-primary outcome parameters are the speech and language test scores of phonological speech sound production, expressive vocabulary, grammar production and language comprehension at T1. The secondary outcome parameters comprise two composite speech and language test scores at T1 and T2, including phonological working memory scores and the individual scores of the aforementioned tests at T2, as well as process evaluation parameters (time expenditure, resource utilisation, such as salary costs of speech–language therapists, additional costs of the online therapy, adherence to appointments and therapy acceptance).

This study has been approved by the Institutional Ethics Review Board of Westphalia-Lippe (2022-282 f-S). Parents provide written informed consent. Findings will be disseminated through presentations, peer-reviewed journals and conferences.

DRKS00030068

Immunosuppression is associated with an increased risk of delayed SARS-CoV-2 viral clearance, severe COVID-19 and related death. This heterogeneous group of affected patients includes but is not limited to those with a haematological malignancy, people on immunosuppressive therapy for the treatment of autoimmune/inflammatory diseases and those following bone marrow transplantation (BMT). Immunosuppression is associated with decreased rates of anti-spike IgG seroconversion following COVID-19 vaccination. While clinical guidelines have been established to guide vaccination pre-splenectomy and post-BMT, there are limited data to guide timing of COVID-19 or other booster vaccines in adults commencing new or intensified moderate to severe immunosuppression. The comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT) study was designed to address this knowledge gap. CIRCUIT investigates whether administration of a third (or subsequent) COVID-19 booster vaccine ≤2 weeks prior to immunosuppression provides greater anti-spike IgG-mediated immunity than a booster given 24 weeks after new or intensified immunosuppression, that is, week 24 timepoint (Group 1; n=280). Additionally, the research will investigate whether giving a fourth post-BMT COVID-19 booster vaccine at 9 months post-transplant provides greater anti-spike IgG-mediated immunity than a booster given 15 months post-transplant (Group 2; n=40).

The CIRCUIT study is an open-label, multicentre randomised clinical trial. Participants will be randomised 1:1 to receive either an additional COVID-19 booster ≤2 weeks pre-immunosuppression and a diphtheria/tetanus toxoids (DT) booster at 24 weeks following new or intensified immunosuppression (week 24 timepoint) or receive a DT booster ≤2 weeks pre-immunosuppression and an additional COVID-19 booster at week 24 (Group 1). Group 2 participants who underwent autologous or allogenic BMT in the last 9 months will be randomised 1:1 to either receive a fourth post-BMT COVID-19 booster at 9 or 15 months post-transplant. The primary outcome will be the integrated time-weighted area under the curve anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months from a SARS-CoV-2 booster as assessed by a high-throughput SARS-CoV-2 NAb platform assay. Key secondary outcomes of the CIRCUIT randomised control trial will include safety and generation of SARS-CoV-2 antigen specific T and B cell responses.

The research protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee on 25 August 2022 (Ref no. 2022/PID00782 – 20022/ETH0069). Study results will be published in peer-reviewed medical journals and presented at local and international conferences. All findings regardless of the outcome will be reported.

NCT05415267.

Persons with childhood-onset intellectual or complex disabilities have an elevated probability of encountering delayed or erroneous diagnoses during hospital treatment. It is imperative to consider the possibility that mistreatment may worsen their health. Persons with intellectual disabilities face numerous challenges in accessing and using healthcare. These challenges include structural and communication barriers, as well as a dearth of competencies among health professionals in interacting with persons with intellectual disabilities. Nevertheless, there is a paucity of studies that analyse the challenges faced by persons with intellectual disabilities in hospital and even fewer that involve persons with intellectual disabilities in the research process. Therefore, the objective of the study described in this protocol is to identify the salient research questions for improving hospital care of adults with childhood-onset intellectual disabilities by collecting and prioritising the different perspectives of patients, caregivers and clinicians.

The study design is based on the Priority Setting Partnership procedure of the James Lind Alliance, encompassing four steps to identify and prioritise issues with patients, caregivers and clinicians. Initially, problems and issues pertinent to those affected are collated using an open online questionnaire and subsequently clustered into topics. In the second step, the topics are transformed into potential research questions and reviewed by available scientific literature. Subsequently, research questions that cannot yet be answered by current literature are prioritised by participants in a second online questionnaire. Finally, the 25 questions rated most relevant are to be discussed in a one-day workshop with participants reflective of all target groups. The salient 10 research questions are to be determined using nominal group technique.

The study has received a positive ethics vote from the Ethics Committee at the Ludwig Maximilian University of Munich in accordance with the Declaration of Helsinki on 21 March 2025 (reference 25-0106). This study’s findings will be shared in academic conferences and published in scientific peer-reviewed journals.

DRKS00037347.

Menstrual health is critical to achieving gender equity and reaching the 2030 Sustainable Development Goals, yet evidence on the health impacts of menstrual products—particularly on the vaginal microbiota—is limited. The Improving Menstrual and Vaginal Health for All (IMVAHA) project aims to address this knowledge gap through qualitative exploration, a health survey and clinical trial embedded in three sister projects: Laura (Peru), Leke (Cameroon) and Marie (Switzerland). This paper outlines the protocol for the IMVAHA health survey and clinical trial studies, which aim to (1) assess menstrual hygiene practices, product preferences and vaginal health; and (2) evaluate longitudinal changes in vaginal microbiota associated with the use of pads, tampons and menstrual cups.

The IMVAHA project will take place in urban Cameroon, urban Peru, and in Switzerland. The baseline survey will explore vaginal and menstrual health behaviours and preferences, including vaginal complaints, menstrual products and menstrual stigma. Descriptive statistics will be calculated for a cross-sectional profile of vaginal and menstrual health within and between contexts, and mixed effects linear regression models will be run to identify associations between contextual factors and key vaginal and menstrual outcomes. From survey participants, 300 eligible, consenting women (100 per country) will be enrolled in a 7-month crossover clinical trial. As a self-controlled trial, a dedicated control group is not necessary. Each participant will use pads, tampons and menstrual cups for two menstrual cycles per product, providing vaginal swabs at baseline and post-menstruation. Swabs will undergo 16S rRNA sequencing, pH testing and screening for toxic shock syndrome-related bacteria. A short survey on health behaviours and symptoms, menstrual hygiene practices and participant experiences with different menstrual products will be administered during each menstrual period. The primary outcome of the clinical trial is the log ratio of Dialister to Lactobacillus crispatus abundance measured after the use of different menstrual products. Mixed-effects linear regression will assess differences in the primary outcome across product types. Secondary analyses will include per-protocol comparisons and ORs with 95% CIs.

The study complies with the Declaration of Helsinki, Council for the International Organizations of Medical Sciences guidelines and local regulations. Ethical approval has been obtained in all three countries (National Ethics Committee for Human Health Research in Cameroon (CE N° 2024/03/1649/CE/CNERSH/SP); the Institutional Review Board of the Universidad Peruana Cayetano Heredia and Universidad Nacional de la Amazonía Peruana in Peru (217572) and the Ethics Commission of Northwest and Central Switzerland (2024-02135)). Informed consent will be obtained from all participants after detailed explanation of study procedures and risks. Data will be securely stored, with participant anonymity maintained. A political economy analysis will explore regulatory environments for menstrual products, and findings will be disseminated through policy briefs, stakeholder networks, academic publications and conferences.

NCT06646185.

To evaluate the effects of nurse-led shared decision-making (SDM) on lung cancer screening outcomes, including low-dose CT (LDCT) uptake, benign findings, early cancer detection and willingness to participate among high-risk populations.

Systematic review and meta-analysis.

PubMed, Medline via OvidSP, Cochrane Central Register of Controlled Trials, EMBASE via OvidSP, Web of Science, Scopus, grey literature databases and clinical trial registries were searched from inception to March 2025.

Studies evaluating nurse-led SDM interventions in high-risk lung cancer populations, reporting outcomes including LDCT uptake rates, screening results (Lung-RADS (Lung Imaging Reporting and Data System) classifications), early-stage cancer detection or willingness to participate. Randomised controlled trials, quasi-experimental studies and observational studies were included.

Two reviewers independently extracted data and assessed risk of bias using the Risk of Bias in Non-randomised Studies of Interventions (for non-randomised studies) and Cochrane Risk of Bias 2.0 (for randomised controlled trials). Meta-analyses were conducted using random-effects models. Meta-regression explored sources of heterogeneity.

13 studies (n=13 608 participants) were included, comprising 10 single-arm studies and three comparative studies. In single-arm studies without control groups, nurse-led SDM programmes achieved a pooled LDCT uptake rate of 98% (95% CI 28% to 100%; I²=99%), and willingness to participate was 68% (95% CI 24% to 93%; I²=98%). In comparative studies, nurse-led SDM showed no significant difference in LDCT uptake compared with usual care (RR 1.00, 95% CI 0.99 to 1.02; I²=0%), suggesting non-inferiority rather than superiority. Among individuals who completed screening, 81% (95% CI 77% to 85%) had benign or low-risk findings (Lung-RADS [Lung Imaging Reporting and Data System] I/II), and 2% (95% CI 1% to 3%) were diagnosed with early-stage lung cancer, rates consistent with benchmark screening trials. Meta-regression identified female sex as positively associated with uptake (β=0.54, p

Comparative evidence suggests that nurse-led SDM achieves equivalent LDCT uptake to standard care approaches, indicating feasibility as an alternative service delivery model. However, the predominance of single-arm studies, high heterogeneity and moderate-to-serious risk of bias limit causal inference. High uptake rates in single-arm studies likely reflect selection bias rather than intervention effectiveness. Current evidence supports the feasibility but not the superiority of nurse-led SDM. Well-designed randomised controlled trials are needed to establish comparative effectiveness and cost-effectiveness before recommending widespread integration of nurse-led SDM into lung cancer screening programmes.

PROSPERO CRD420251033595. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=1033595.

Data on long-term outcomes after surgical repair of pulmonary valve stenosis are limited. This study evaluated survival, clinical outcomes and quality of life (QoL) after surgery during childhood.

Single centre, longitudinal cohort study evaluating consecutive patients with pulmonary valve stenosis who underwent surgical repair between 1968–1980 and were evaluated every decade since 1990.

Of the original cohort of 89 operated patients, 11 died (12%), including 2 who died within 30 days postsurgery (2%), and 7 (8%) were lost to follow-up. Survival at 50 years follow-up was 87%, which was not significantly different from the GDP. Of the remaining 71 survivors, 32 refrained earlier from participating in this cohort study, leaving 39 eligible, of whom 34 (87%) participated again (50% male, median age 48 years) with a median follow-up of 45 (range 40–52) years. Event-free survival was 50%, with supraventricular tachycardia (14%) and reintervention (13%) being the most frequent events, although less frequently in the last 10 years. At last follow-up, biventricular function was preserved in most patients. Reduced right and left ventricular ejection fraction (EF) was found in 33% and 13%, respectively. Exercise capacity and maximum rate of oxygen consumption were mildly impaired in 14% and 32% of patients. Patients who underwent an infundibulectomy during initial surgery were significantly more likely to undergo reintervention (HR=8.32, p=0.003). Patient-reported QoL scores remained stable over time and consistently exceeded those of the age-matched GDP.

Fifty-year survival after surgery for pulmonary valve stenosis was excellent and comparable to the GDP. Most patients maintained preserved ventricular function, functional capacity and excellent QoL. Routine lifelong follow-up may not be necessary for all patients, but should be considered for those who underwent an infundibulectomy or have residual lesions.

Obesity is a global public health issue, with its effects a particular issue in Kuwait. Advances in pharmaceutical treatment (eg, glucagon-like peptide-1s) offer an effective solution, with the magnitude of weight lost something to celebrate. However, this level of weight loss also results in dramatic reductions in lean mass, reflecting loss of muscle mass and muscle strength which can predispose people to sarcopenia. This is a particular issue in people with type 2 diabetes in Kuwait, where the prevalence of muscle weakness is extremely high. Solutions to mitigate this loss of muscle mass and strength are needed, with a pragmatic resistance exercise intervention and increasing dietary protein intake having potential. This trial aims to determine whether resistance exercise and/or protein intake can preserve muscle mass and improve physical function in people with obesity initiating semaglutide/tirzepatide therapy.

This single-centre, 6-month, randomised controlled trial at Dasman Diabetes Institute will enrol 232 adults with obesity, randomised (1:1:1:1) to control, resistance exercise, protein supplementation or combined resistance exercise and protein in conjunction with semaglutide or tirzepatide therapy. Resistance exercise will be home-based and involve three sessions per week, progressing from one to three sets targeting major muscle groups. Protein supplementation will target 1.6 g/kg/day via dietary adjustment and protein products. Assessments at baseline and 6 months will include MRI measured quadriceps cross-sectional area (primary outcome), plus measures of secondary outcomes of MRI measured liver fat content and stiffness and intramuscular fat, body composition (dual energy X-ray absorptiometry), strength, physical function, dietary assessment, physical activity levels, sleep patterns, quality of life, glycaemic control and metabolic biomarkers.

The study has received ethical approval from the Dasman Diabetes Institute Ethical Review Committee (HR-RA-2025-01, 19 February 2025) and is registered at ClinicalTrials.gov (NCT06885736, 26 June 2025). Written informed consent will be obtained from all participants, with no financial compensation provided. Data will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines, ensuring participant anonymity. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.

NCT06885736.

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.

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).

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.

Open Science Framework: https://osf.io/et85d