BACKGROUND:Appropriate terminology and definitions of neonatal encephalopathy (NE), hypoxic-ischemic encephalopathy (HIE), and perinatal asphyxia (PA) remain controversial. Participant criteria used in therapeutic hypothermia (TH) trials are frequently used as case definitions for NE/HIE/PA but studies are inconsistent. This review aims to assess variations in terminology and case participant criteria between trials for NE/HIE/PA. METHODS:Search strategy retrieved articles from databases (Embase, MEDLINE, CENTRAL, CDSR and WHO) for randomized controlled trials (RCTs) of interventions for NE/HIE/PA using any definition for NE/HIE/PA. Outcomes were a description of the terminology, definitions, and participant criteria. Two reviewers independently screened results. Qualitative results were synthesized in a narrative summary. RESULTS:The search provided 6768 results. 67 were included in the qualitative synthesis. HIE was the most frequently used term (56/67). NE was the least frequent (16/67). Some of the common inclusion criteria were Apgar scores (63/67), metabolic acidosis (58/67), and reduced level of consciousness (57/67). Most frequently employed exclusion criteria were prematurity (63/67), major congenital abnormalities (62/67), and identification beyond 6 h from birth (62/67). DISCUSSION:This review identified variations in terminology and in-trial participant criteria between studies. These results will inform a consensus process for developing a definition and case definition of NE/HIE/PA. IMPACT:Our article demonstrated significant variations in the terminology used to describe the condition of NE/HIE/PA, which demonstrates a need for more consistent definitions in terminology. A broad but meaningful definition of the condition would provide an inclusive approach while permitting subclassifications within the condition, and permitting comparisons and benchmarking across different settings. Developing consistency across these areas, as far as possible, would allow improved interpretation of interventions on long-term prognosis and greater generalizability of trial results.

BACKGROUND AND OBJECTIVES:Podcasts can make health evidence easier to follow, but it is unclear whether artificial intelligence (AI)-assisted production can match human production when both use the same audio format. This trial will evaluate whether a vetted AI workflow can match human communicators on comprehension, quality, safety, accessibility, and trust when both deliver podcasts derived from the same evidence base. METHODS:We will run a randomized, two-arm, noninferiority trial comparing AI-assisted podcasts with human-produced podcasts. Adults (≥18 years; English-proficient) will be recruited from the general public via Prolific, an online research participant recruitment platform, and randomly allocated 1:1 to listen to three short episodes (6-8 minutes each) based on the same Cochrane Plain Language Summaries. The AI arm uses Wondercraft AI in a human-in-the-loop workflow; the human arm features experienced communicators working to an identical brief. In both arms, content is limited to the plain language summary, with authorship masked for participants and expert raters. The primary outcome is comprehension, measured by a 10-item test per episode, with the primary analysis using the participant-level mean score across the three episodes, aligned with the "Understanding" dimension of the Quality, Understanding, Expression, Safety, and Trust framework. Secondary outcomes include format accessibility (listenability), quality of information, perceived trust, and safety. Noninferiority margins are prespecified; for comprehension, the margin is 1 point on the 10-item scale. If noninferiority is shown, we will also assess superiority. We plan to recruit 458 participants. Differences between arms will be estimated using appropriate repeated-measures models, with two-sided 95% confidence intervals. RESULTS:This is a study protocol; results will be reported on completion of the trial. CONCLUSION:By providing head-to-head evidence in the same audio format, the study will address a practical question faced by journals and health organizations already experimenting with AI tools: can AI generate clear, safe, and trusted audio content at scale, and where does human input remain essential?

Objectives: To compare the comprehension, readability, quality, safety, and trustworthiness of artificial intelligence (AI)-assisted vs human-generated plain language summaries (PLSs) for Cochrane systematic reviews. Study Design: Randomized, parallel-group, two-arm, noninferiority trial (ISRCTN85699985). Setting: Online survey platform, September 2025. Participants: Adults aged 18 years or older with a minimum English reading proficiency of 7 out of 10, recruited via Prolific. Of the 500 individuals screened, 465 were randomized and 453 completed per-protocol analysis. Interventions: Participants were randomly assigned to three AI-assisted PLSs developed with ChatGPT and human-in-the-loop verification, or to three published human-generated Cochrane PLSs for the same reviews. Outcomes: Primary: comprehension (10-item questionnaire, noninferiority margin 10%). Secondary: readability quality and safety, trustworthiness, and authorship perception. Results: Mean comprehension scores were 88.9% (n = 228) in the AI-assisted group and 89.0% (n = 225) in the human-generated group (mean difference-0.03 percentage points, 95% CI:-1.9% to 2.0%); the upper CI bound (2.0 percentage points) did not exceed the +10 percentage-point noninferiority margin, demonstrating noninferiority. Flesch-Kincaid Grade Level showed no significant difference (8.20 vs 8.38, P = .722), although formal noninferiority was missed (upper 95% CI bound 1.72 exceeded the 1.0 grade level margin). AI-assisted summaries scored higher on Flesch Reading Ease (63.33 vs 50.00, P = .008) and lower on the Coleman-Liau Index. All summaries met prespecified quality and safety standards (100% in both groups). Trustworthiness scores were comparable (3.98 vs 3.91, difference 0.068, 95% CI:-0.043 to 0.179; meeting noninferiority). Participants demonstrated limited ability to distinguish between authorship, correctly identifying AI-assisted summaries in 56.3% of cases and human-generated summaries in 34.7% (approximate to chance for a three-option question), with 55.4% of human-generated summaries misattributed as AI-assisted. Exploratory subgroup analysis showed an age interaction (P = .023), though based on a small subgroup (n = 14, 3%). Conclusion: AI-assisted PLSs with human oversight achieved comprehension levels noninferior to those of human-generated Cochrane summaries, with comparable quality, safety, and trust ratings. AI summaries were largely indistinguishable from those generated by humans. Pretrial verification identified and corrected numerical errors, confirming the need for human oversight. These findings support human-in-the-loop AI workflows for PLS production, though formal evaluation of the time and resource implications is needed to establish efficiency gains over traditional manual methods. (c) 2025 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Background Maternal mortality rates show disproportional disparities among disadvantaged groups. Objective To conduct an overview of qualitative systematic reviews to summarise the antenatal care experience of ethnic minority and underserved, marginalised and disadvantaged women in high-income countries. Search strategy Seven electronic databases were searched to identify reviews published between 2011-2022. Selection criteria Two reviewers independently screened search results and full texts of potentially eligible articles. Data collection and analysis Data were extracted by two independent reviewers, critically appraised using the JBI tool and assessed for overlap. A thematic analysis was conducted. Main results Nineteen qualitative reviews were included. Most were conducted in the UK (n=12) and provided a thematic synthesis of findings. Studied populations included women from minority ethnic groups and those who were migrants, homeless, refugees, asylum seekers, disabled, obese, or had experienced genital mutilation or human trafficking. Common challenges included language and cultural differences, and lack of effective interactions with healthcare professionals. Many women experienced discrimination, isolation, limited awareness of available services and negative attitudes from maternity care staff. Limited access to maternity services was influenced by various factors, including costs and communication barriers. Positive experiences included interactions with culturally responsive healthcare professionals, support from social groups, and access to interpreters. Conclusions Our findings highlight the complex challenges some women face during maternity care. Future research should focus on more personalised care solutions, long-term evaluations of maternity services, training of healthcare professionals, and ways to improve the quality of information provided and the interaction with healthcare professionals.

Background:Limited public understanding of randomized controlled trials (RCTs) hinders recruitment, retention, and confidence in research. Early exposure to trial concepts may strengthen health literacy and research engagement. The Kid's Trial was a global, decentralized, child-led study that cocreated and conducted an RCT to help children understand trials and their importance and to improve critical thinking. Objective:This paper evaluated the feasibility and methodological implications of engaging children in the cocreation and conduct of a fully online RCT. Methods:The Kid's Trial ed a dedicated website guiding children through each step of designing and conducting an RCT. Materials were codeveloped with 2 patient and public involvement groups of children and parents. Any child aged 7-12 years could take part in as many steps as desired. Recruitment combined online and offline strategies, and engagement and self-reported learning were descriptively analyzed. The cocreated Randomized Evaluation of Sleeping With a Toy or Comfort Item (REST) trial was a 2-arm, pragmatic RCT comparing one week of sleeping with a comfort item versus without a comfort item. The primary outcome was sleep-related impairment, and the secondary outcome was overall sleep quality. Analyses followed an intention-to-treat (ITT) approach using mixed effects models adjusted for baseline measures. Results:Overall, 224 children participated in at least one step of The Kid's Trial. Participation varied: 37% (n=82) completed one step, and 21% (n=48) completed 6 surveys. The REST trial randomized 139 children, with 73% (n=101) completing outcome surveys. Adjusted mean differences (intervention - control) were -0.53 (95% CI -3.40 to 2.34) for sleep-related impairment (P=.71) and 0.28 (95% CI 0.01-0.55) for sleep quality (P=.04). The difference was small and was not supported by sensitivity analyses. Poststudy responses (n=20) suggested improved self-reported trial understanding among respondents but were limited by low response rate and potential selection bias. Conclusions:The Kid's Trial demonstrates the feasibility of a decentralized, child-led RCT cocreated through participatory citizen-science methods. Children can meaningfully contribute to trial design and conduct, and experiential participation may support engagement with trial concepts. Future studies should enhance engagement through community partnerships, shorter intervals between steps, and embedded learning assessments to improve inclusivity and retention.

Background NICE guidance recommends that pregnant women should be engaged in evidence-based discussions about planned mode of birth (MOB) options. Decision aids can assist these discussions; however, no such resource exists for routine antenatal care. This qualitative evidence synthesis aimed to identify the information and decision-support needs of women planning MOB in high-income countries. Methods We searched seven electronic bibliographic databases for articles published in English from 1 st January 2011 up to 15 th November 2022. Studies were included if they provided qualitative data from current/previously pregnant women, without specific complications, about their information and decision support needs when planning MOB in a high-income country. Identified sub-themes were grouped and mapped onto three pre-established global themes: Important information needs , Decision support needs and Timing of decision support . Quality assessment was conducted using the CASP checklist for qualitative studies. Results Thirty-three studies of 2764 participants were included. Most studies were of adequate quality. Women want clear, balanced information comparing the risks/benefits of planned vaginal or caesarean birth. They were frustrated that they often received inadequate and/or unbalanced information. Information about other women’s experiences was often valued more than impersonal information. Conclusions A decision aid is needed to support personalised and balanced MOB discussions as part of routine antenatal care in the NHS.

OBJECTIVE To assess whether initiating metformin at 25 weeks' gestation influences exclusive breastfeeding at 12 weeks postpartum in gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS We performed a prespecified secondary analysis of the Effectiveness of Metformin in Addition to Usual Care in the Reduction of Gestational Diabetes Effects (EMERGE) trial, a multicenter, double-blind, placebo-controlled randomized study. A total of 535 pregnant women (510 with newly diagnosed GDM) were allocated 1:1 to metformin (titrated to 2.5 g/day) or placebo alongside usual care. Infant feeding was prospectively documented at birth and at 4 and 12 weeks postpartum. The primary outcome was exclusive breastfeeding at 12 weeks (intention to treat). Multivariable logistic regression adjusted for race, education, smoking, booking BMI, health care access markers, and diagnostic oral glucose tolerance test (OGTT) glucose levels. RESULTS Twelve-week feeding data were available for 476 pregnancies (236 in the metformin group and 240 in the placebo group). Exclusive breastfeeding at 12 weeks was 27% with metformin and 26% with placebo (absolute difference +1.3%; 95% CI –6.3 to 8.7; P = 0.75). The adjusted odds ratio (OR) for metformin versus placebo was 1.24 (95% CI 0.79–1.96; P = 0.36). Feeding patterns shifted from breastfeeding to formula temporally in both groups (P < 0.001), with no treatment-by-time interaction (P = 0.61). Non-Caucasian ethnicity independently predicted exclusive breastfeeding (adjusted OR 2.37; 95% CI 1.27–4.42). CONCLUSIONS Starting metformin treatment at 25 weeks in the GDM group was not associated with differences in exclusive breastfeeding at 12 weeks postpartum. Where metformin was discontinued at delivery, the results support compatibility of antenatal metformin with breastfeeding objectives. Breastfeeding outcomes were more linked to sociodemographic factors than metabolic ones, highlighting the need for culturally appropriate postpartum support.

Abstract Background Planned caesarean birth (CB) is an increasingly utilised intervention, observed in almost 1 in 6 first-time mothers giving birth in the UK in 2023-24. Outcomes of planned (or actual) CB have been compared with planned (or actual) vaginal birth (VB) in a UK national guideline, but the scope of the comparison does not fully reflect the range of outcomes of interest to stakeholders. This review provides a comprehensive synthesis of outcomes of planned or actual CB with planned or actual VB to shape information resources which support informed birth planning. Methods The UK NICE Caesarean Birth Guideline NG192 evidence review of outcomes associated with planned CB (or actual CB where no planned CB data was available) was updated and expanded to incorporate additional outcomes prioritised by stakeholders. Results A total of 33 new study reports were combined with 32 reports previously included in NG192. All new reports were observational cohort studies or systematic reviews at low risk of bias. Only 3 studies reported outcomes of planned CB compared with planned VB (regardless of actual mode of birth), whereas all remaining studies reported actual VB outcomes. Planned CB was followed by more maternal infection (wound infection, mastitis, endometritis and urinary tract), venous thrombosis and lower neonatal unit admission rates than a planned VB. In the long-term, CB was linked to one or more sexual problems (insufficient lubrication and dyspareunia) being more common, future pregnancy being less common, and infertility being more frequent than after VB. For offspring, infant urinary tract infection after any CB, gastrointestinal tract infections and autism after planned CB were more common compared with VB. New findings highlight conflicting reports on childhood asthma and type 1 diabetes risk after planned CB, suggesting that prior positive associations may be explained by confounding. Existing evidence in NG192 suggests that cardiac arrest, maternal death and hysterectomy are more common after planned CB, but arise from studies at high risk of bias. NG192 also reports that placenta accreta and uterine rupture in a future pregnancy are more common after any CB. No new evidence was identified on these outcomes. Conclusion This review provides stakeholder-relevant information to populate decision-support materials on outcomes of planned (and actual) CB compared with planned (and actual) VB. The existing evidence base lacks data on long-term outcomes of planned (rather than actual) VB.

ABSTRACT Introduction Decisions need evidence, and for healthcare decisions, the evidence decision‐makers often want is a systematic review. However, reviews often lack clarity about who is represented within the evidence they synthesize, which limits understanding of how findings apply to diverse populations. PRO EDI was developed to help systematic review authors extract and report equity‐related participant data to support greater transparency and more informed judgments about applicability. Methods PRO EDI was developed iteratively between August 2022 and March 2024 and was conceptualized as a way of making it easier to use PROGRESS‐Plus, a framework to assess equity in reviews. An initial draft was created and then discussed and revised in collaboration with an international advisory group. A relatively mature version of the tool was then presented to a meeting of the Cochrane Health Equity Thematic Group. The modified version that emerged from that meeting was considered v1 of PRO EDI. Results PRO EDI has two main components: a participant characteristics table and guidance on how to use the extracted characteristics data within reviews. PRO EDI recommends that six participant characteristics should be extracted for all included studies in a review: age, sex, gender, ethnicity, race and ancestry, socioeconomic status, and location. Other characteristics (e.g., disability) may be important for some reviews. PRO EDI is relevant for all systematic reviews, not just those with an equity focus. The tool has been piloted in several reviews and is publicly available via Trial Forge. Conclusion PRO EDI gives systematic review authors a consistent way of deciding which participant characteristics to extract from included studies to support equity‐related judgments in their results and discussion. It also suggests ways in which those judgments can be presented.

Neonatal encephalopathy refers to disturbed neurological function in the neonatal period and has multiple potential aetiologies. A systematic review showed that neonatal encephalopathy, hypoxic-ischaemic encephalopathy, and perinatal asphyxia are often used interchangeably in clinical trials and communications. We aimed to establish an international, consensus-based definition as a preliminary step towards standardising terminology. Findings from a systematic review of definitions guided the creation of a real-time Delphi survey. Three consensus meetings were held to finalise the definition, which was approved by the steering committee. Participants were recruited from a broad range of stakeholder groups, including health-care providers; researchers; parents, family members, guardians, or representatives of children with neonatal encephalopathy; or adults who had neonatal encephalopathy as infants. From Feb 1 to May 31, 2024, the survey received 235 complete and 143 partial responses. Respondents were from 52 countries, with 75 (20%) from low-income and middle-income countries. Although most respondents were health-care workers, 23 (6%) represented parents and caregivers. 62 individuals participated in at least one consensus development meeting. The final definition was organised into primary, secondary, and tertiary domains. The primary domain is as follows: neonatal encephalopathy is a heterogeneous clinical condition characterised by abnormal or impaired brain function with multiple potential causes. It presents with an altered level of consciousness and may include seizures, abnormal primitive and deep tendon reflexes, altered muscle tone, posture or movements, or an abnormal brain-related breathing pattern. Neonatal encephalopathy can be associated with a heightened risk of morbidity and mortality. This Delphi process established a novel consensus definition for neonatal encephalopathy, with contributions from a diverse range of international stakeholders, including families. Adopting consensus-based terminology and definitions will enhance communication among health-care professionals and families, facilitate research and data synthesis, improve the interpretation and application of research findings, and ultimately improve care.

Background Male foetal sex is recognised as an independent risk factor for adverse pregnancy outcomes including preterm birth, neonatal care unit admission and lower Apgar scores. Male foetuses appear to increase the risk of maternal gestational diabetes in the mother due to impacts on beta cell function, and in pregnancies impacted by gestational diabetes, male offspring have higher rates of hypoglycaemia, respiratory distress and macrosomia. Metformin exposure in animal models has also demonstrated sex-specific effects with different patterns in adiposity and lipid levels observed between male and female offspring exposed to metformin in utero. The aim of this analysis is to determine whether foetal sex modifies maternal and neonatal outcomes in gestational diabetes, and evaluate the sex-specific response to metformin on insulin usage, fasting glucose at 32 and 38 weeks and foetal size. Methods We conducted a secondary analysis of the Early Metformin in Gestational Diabetes (EMERGE) randomised controlled trial and analysed neonatal outcomes according to sex and metformin exposure. Results At randomisation, women carrying a male foetus had a higher plasma glucose at 60 min on oral glucose tolerance testing (9.69 vs. 9.37 mmol/L, p = 0.039). In exploratory analyses, metformin exposure in male pregnancies was associated with lower fasting glucose at 32 (4.88 vs. 5.01 mmol/L, p = 0.014) and 38 weeks (4.49 vs. 4.69 mmol/L, p = 0.002) and reduced insulin use (38% vs. 53%, p = 0.014), with smaller effects in female pregnancies. Metformin-exposed females had higher rates of birth weight < 2500 g compared to those exposed to placebo (8.3% vs. 1.9%, p = 0.032), which was not observed in metformin-exposed males. More male offspring had a birth weight > 4000 g compared to female offspring regardless of metformin exposure. However, the sex-by-treatment interaction was not significant, so these findings should be regarded as hypothesis-generating. Glucometer data suggested a greater mean glucose reduction in males than females (0.29 mmol/L (95% CI 0.29-0.30) versus 0.21 mmol/L (95% CI 0.20-0.21)). Conclusions Further follow-up is required to determine whether foetal sex influences long-term effects of metformin in pregnancy.

BACKGROUND:Challenges in recommendations regarding optimal nutrition for preterm infants are partly due to inconsistent reporting of outcomes in nutrition intervention studies. We aimed to develop a standardised reporting framework for measures of nutritional intake and growth outcomes in preterm nutrition studies. METHODS:Measures of nutritional intake and growth outcomes were identified in a scoping review, curated, and presented to participants from three stakeholder groups with experience in preterm infants, nutrition, and growth in two real-time Delphi surveys, the first on which measures should be reported and the second on how to report these measures. All questions were rated for their importance on a 9-point Likert scale. The standardised reporting framework was finalised during three online consensus consultation meetings. RESULTS:We recruited 313 participants from 32 countries for survey 1, and 121 participants from 26 countries for survey 2. The proportions of stakeholder groups in both surveys were similar, comprising 12% consumers, 73-77% healthcare professionals, and 11-15% researchers. Eight measures were included in the final standardised reporting framework, together with the associated measurement methodologies. CONCLUSIONS:A standardised minimum reporting framework for measures of nutritional intake and growth outcomes was developed to enhance consistency in reporting of preterm nutrition studies. IMPACT:This study provides the first multidisciplinary international consensus on reporting of nutritional intake and growth outcomes in preterm nutrition studies. We propose a standardised minimum reporting set of eight nutrition and growth measures, together with assessment methodologies, that should be reported, as a minimum, in all studies of nutrition and growth in preterm babies. Widespread adoption of this framework would standardise reporting in an area that currently is highly variable, improving the comparability of research findings, facilitating reliable evidence synthesis, and potentially supporting the development of evidence-based clinical guidelines for preterm nutrition.

Pregnancy and early infancy are periods of heightened vulnerability, with SARS-CoV-2 and influenza infections linked to adverse pregnancy outcomes, including preterm birth, and stillbirth. Maternal vaccination provides direct protection to mothers by active immunisation and to infants by passive immunisation. This scoping review mapped and described published literature on maternal vaccination against COVID-19, influenza, pertussis, and RSV, including which outcome domains were studied and the timing of vaccination examined, with the aim of identifying evidence gaps and supporting decision-makers in choosing priority areas for subsequent systematic review topics. A comprehensive literature search across multiple databases of studies published from January 2000 to October 2025 identified 636 publications (541 primary studies, 95 evidence syntheses). Studies on COVID-19 (261 studies, 45 reviews), influenza (161 studies, 29 reviews), pertussis (113 studies, 20 reviews), and RSV (20 studies, 11 reviews) were analysed. Substantial evidence on COVID-19, influenza, and pertussis vaccination on efficacy, effectiveness, safety and immunogenicity outcomes and the optimal timing of vaccination in relation to these outcomes during pregnancy is available. RSV vaccination evidence is limited. Updated systematic reviews would be helpful to clarify the optimal timing of COVID-19 vaccination and the effectiveness and safety of the coadministration of influenza and pertussis vaccines.

Randomised controlled trials that use cohorts or health-and-care systems data, often known as routinely collected data-such as electronic health records, registries, or administrative claims-are becoming increasingly common. These trials have the potential to streamline recruitment, intervention delivery, follow-up (within trial and long term), and to lower costs. The lack of clear information governance pathways, heterogeneous data quality, delays in data recording and acquisition, and regulatory or ethical complexities undermine reproducibility and bias assessment when routinely collected data are used in trials. We introduce the SPIRIT-ROUTINE extension to the SPIRIT 2025 guideline: a checklist and explanation designed to improve the reporting of trial protocols that rely on cohorts or routinely collected data sources. Investigators, funders, ethics committees, journal editors, and peer reviewers can use the SPIRIT-ROUTINE extension to enhance completeness, transparency, and usability of such protocols to support better research, healthcare decisions, and patient outcomes.

Background and Objectives Health guidelines play a central role in informing clinical practice, public health measures and health policy. But their trustworthiness may be undermined by factors such as insufficient methodological rigor, lack of transparency, conflicts of interest, and inconsistent application of established standards. Existing appraisal tools address selected aspects of guideline quality but do not comprehensively assess the trustworthiness of individual recommendations, nor do they adequately reflect recent advances in guideline methodology, including living guidelines, Grading of Recommendations, Assessment, Development, and Evaluation, adaptation, and the use of artificial intelligence (AI). This study aims to develop and validate Transparent, Rigorous, Useable, Standardized, and Trustworthy Guide (TRUSTGUIDES), a globally applicable, flexible set of tools to assess the trustworthiness of health guideline recommendations. We define trustworthiness as distinct from methodological quality: it encompasses not only rigorous methods but also transparency, independence, and applicability, which together determine whether a recommendation merits user confidence. Methods TRUSTGUIDES will be developed through a multistep, mixed-methods process. First, a scoping review and expert consultation will identify existing guideline appraisal tools and inform domains and items generation. Using deductive and inductive approaches, domains and items will be generated and may be refined through focus groups and selected through iterative Delphi surveys involving an international, multidisciplinary working group. TRUSTGUIDES will be validated by assessing internal consistency, inter-rater reliability, content validity, and construct validity, including comparisons with established instruments such as the Grading of Recommendations, Assessment, Development, and Evaluation certainty domains, AGREE II, and PANELVIEW. Psychometric properties will be examined using factor analysis and, as necessary, item response theory models. AI will be integrated both as an object of assessment and as methodological support for tool application, with large language models evaluated against a human reference standard. Conclusion TRUSTGUIDES will be designed to evaluate the trustworthiness of individual guideline recommendations across key factors, including transparency and credibility, and to address relevant domains such as the certainty of evidence, strength of recommendations, conflicts of interest, applicability, adaptability, currency, certification, and the appropriate use of AI. TRUSTGUIDES addresses critical gaps in current guideline appraisal by offering a comprehensive, recommendation-level assessment of trustworthiness aligned with the World Health Organization guideline standard methodology. By integrating AI, our tools will support efficient, transparent, and future-ready guideline evaluation within an evolving health evidence ecosystem.

Background and Objectives Rapid reviews are widely used to produce timely evidence for health and policy decisions, yet considerable heterogeneity exists in how they are justified, conducted, and reported. This study aims to characterize, across a stratified random sample of recently published rapid reviews in health, the rationales for choosing a rapid review approach, the methodological streamlining strategies employed, and the reporting guidance or checklists referenced or reported as followed. Study Design and Setting This is a prospectively registered study within a review (SWAR), a methodological design that treats published evidence syntheses as the data source. Eligible rapid reviews will be identified from MEDLINE (Ovid), Embase, the Cochrane Database, and Epistemonikos, restricted to publications from January 2025 onward. If more than 150 eligible reviews are identified, a random sample of 150 will be selected, stratified by year and broad review type. Methods We will screen records and extract data using a piloted, structured extraction form organized around three domains: rationale for conducting a rapid review; methodological streamlining strategies mapped against key review stages; and reporting guidance cited. Findings will be summarized using descriptive statistics and a structured narrative synthesis. Exploratory analyses will examine the frequency of core transparency items by year and review type. Conclusion This SWAR will provide a focused, empirically grounded characterization of recent rapid review practice across rationale, methods, and reporting. Findings are intended to inform future guidance development, support training, and establish a benchmark for monitoring changes in the conduct of rapid reviews and transparency.

Background Health misinformation is a serious and growing concern, especially in the era of mass digitalization. However, the term lacks conceptual clarity, reducing our ability to build a reliable, replicable evidence base about how misinformation works and undermining our attempts to develop effective responses. There is, therefore, a need to examine how the term is used and to develop a coherent definition that better reflects people’s information priorities, concerns, and understandings of the concept. Objective This study aimed to surface common themes and debates around the concept of “misinformation” in contemporary English-language discourses about health. Specifically, we aimed to examine how people understand the problem of health misinformation (ie, its causes and consequences), how they perceive the relationship between “misinformation” and other problematic information, and any unresolved conceptual tensions. Methods We conducted a 3-phase hybrid concept analysis following a framework from Schwartz-Barcott and Kim (2000), comprising (1) a theoretical, literature-based phase, (2) a fieldwork/primary interview phase, and (3) an integrative phase combining findings from the first 2 phases. This paper reports methods and findings from the first phase, an inductive, qualitative literature review and analysis. In this phase, we conducted a systematic search of recent literature on health misinformation (published between 2016 and 2022), selected a stratified random sample, and conducted inductive thematic analysis following the methods outlined by Rodgers (2000). A thematic, narrative summary of the findings is presented herein. Results Authors identified rapid technological change, information predators, and cultural issues (eg, social fragmentation, growing epistemic disagreement, and the loss of information authorities) as antecedents to health misinformation. They characterized health misinformation as a scourge, identifiable by its falseness or deceptiveness, the use of persuasive strategies, unscientific subjectivity, and its capacity to disrupt community consensus, and highlighted a broad range of potential consequences for individuals, communities, and social systems. However, there were also major areas of divergence and tension in this literature base. Specifically, there was disagreement about what kinds of problematic content constituted “misinformation,” and how misinformation should be identified or adjudicated, especially in cases of evidentiary uncertainty or legitimate scientific disagreement. Conclusions To our knowledge, this is the first review to examine both explicit and implicit definitions of misinformation and to center contemporary usages of the concept. The work identifies several key characteristics of health misinformation, as well as areas where further concept development is needed. The review highlights the need for explicit reporting around the operationalization of the term, implementation of standards for communicating evidentiary uncertainty, values-aligned and co-designed health communications, and continued concept development. Findings from this literature analysis will inform further stakeholder and integrative synthesis, with the goal of developing a more usable, inclusive, and responsive definition of health misinformation. International Registered Report Identifier (IRRID) RR2-10.12688/hrbopenres.13641.2