OBJECTIVE:To systematically summarise people's health-related values and preferences related to fat intake. DESIGN:We searched five databases for studies reporting people's perspectives on fats. Screening, data extraction and risk of bias assessment were performed by two independent reviewers. Data was analysed using a convergent integrated approach and the certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation methodology. SETTING:Qualitative and quantitative studies from any country or language. PARTICIPANTS:Primary studies of adults, with or without cardiometabolic conditions. RESULTS:From 52 166 records, we included eleven quantitative and two qualitative studies; studies were primarily conducted in high-income countries. Five main themes were identified: (i) negative perception of fat in food, (ii) positive perception of vegetable oil as being beneficial to health, (iii) willingness to lower fat consumption, (iv) willingness to pay for healthier fat content and (v) barriers towards unsaturated fat consumption. The most frequently reported themes were negative perception of fat and willingness to consume low-fat products, while prioritising vegetable oil as a healthy fat. The evidence certainty for these themes was very low to moderate, rated down for risk of bias and indirectness issues. CONCLUSIONS:People's perception of fats and oils in diets is complex and often contradictory; most viewed high-fat products as unhealthy and associated with weight gain, while vegetable oils were generally perceived as beneficial. However, views varied significantly depending on sex, age and dietary patterns. Overall, the evidence supporting these perceptions is of moderate to very low certainty and to inform guideline recommendations more research is needed.
BACKGROUND:For patients with immune thrombocytopenia (ITP), a critical bleed, such as intracranial hemorrhage or bleeding causing hemodynamic instability, requires urgent treatment to rapidly raise the platelet count and restore hemostasis. There is no standardized approach to this hematologic emergency. OBJECTIVE:The McMaster ITP Emergency Management Guideline Group developed evidence-informed recommendations for the management of a critical bleed in adults and children with ITP. METHODS:The guideline panel included 5 clinical experts in adult ITP, 3 clinical experts in pediatric ITP, 2 emergency department physicians, 1 emergency department nurse, 2 methodologists, and 4 patient partners. To inform recommendations, the guideline team conducted a multicenter retrospective cohort study and systematic reviews. The panel used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to rate the certainty in the evidence and GRADE evidence-to-decision framework to formulate recommendations. RESULTS:Given the life-threatening nature or significant morbidity associated with the condition, despite low or very low certainty in the evidence, the panel made strong recommendations for the combined use of high-dose corticosteroids, high-dose IV immunoglobulin (IVIG), platelet transfusions, tranexamic acid, and thrombopoietin receptor agonists (TPO-RAs) for the treatment of adults or children with a critical ITP bleed. The panel made a conditional recommendation for urgent splenectomy when other treatments have failed and, due to the risk of thrombosis, a conditional recommendation against the use of recombinant factor VIIa. CONCLUSIONS:Motivated by the life-threatening nature of the condition, the panel made strong recommendations for the combined use of high-dose corticosteroids, high-dose IVIG, platelet transfusions, tranexamic acid, and TPO-RAs for the emergency management of adults and children with a critical ITP bleed.
Aim:Chronic cough is a common and burdensome condition with limited licensed therapies. Current guidelines recommend identifying treatable traits and using off-label therapies based largely on small clinical trials, but the real-world effectiveness of this approach remains unclear. This study aimed to evaluate the effectiveness of guideline-based therapies on objective and patient-reported outcomes in patients with chronic cough attending a tertiary cough clinic. Methods:PROCOUGH was a prospective, single-centre, observational cohort study conducted at McMaster University Medical Centre (December 2021 to May 2025). Adults with chronic cough (>8 weeks) underwent comprehensive assessment, including lung function testing, airway inflammation measures, sputum cytology and 24-h cough monitoring (VitaloJAK™), alongside patient-reported outcomes. Patients were treated according to European Respiratory Society guideline recommendations, with all assessments repeated after a treatment trial. The primary outcome was change in 24-h cough frequency. Secondary outcomes included Leicester Cough Questionnaire (LCQ) and Cough severity visual analogue scale (CS-VAS). Responder analyses were based on ≥30% cough frequency reduction, ≥30 mm CS-VAS improvement and ≥1.3-point LCQ increase. Results:100 patients completed follow-up (mean±sd age 58.1±14.0 years; 58% female; median cough duration 7 years). Treatment resulted in a 54% reduction in 24-h cough frequency (95% CI 42.0-62.9%), a 20.2-mm decrease in CS-VAS (95% CI -26.2- -14.2) and a 3.4-point increase in LCQ (95% CI 2.6-4.2). Individually, 56%, 36% and 64% met cough frequency, CS-VAS and LCQ responder criteria, respectively, but only 14% met all three. Despite treatment, 71% reported insufficient cough control. Conclusion:Guideline-based therapy improves objective and subjective cough outcomes; however, most patients fail to achieve satisfactory symptom control, highlighting a substantial unmet need for effective treatments for refractory unexplained chronic cough.
Background Health researchers rely on clear, trustworthy methods guidance (MG) to support the planning, conduct, analysis, and interpretation of their studies (eg, guidance on study design, data collection, statistical methods, qualitative analysis). MG should not only be practically useful but also help ensure that the resulting evidence is valid and meaningful to patients, research participants, and other interest-holders. However, how to develop such methods guidance and which processes and approaches are useful is currently unclear. Important uncertainties include how to integrate methodological evidence and the views of health researchers, the intended users. This lack of clarity in the development process may undermine the validity, trustworthiness, and usefulness of MG, ultimately limiting its contribution to the production of high-quality, patient-important evidence. Objectives To describe STrategies for developing REseArch Methods guidance (STREAM). Methods We will work with a steering committee consisting of MG developers, health researchers, and an experienced patient partner who will help us establish a deliberative and meaningful patient contribution. To systematically develop STREAM, we will conduct a series of interlinked studies: (1) Review of existing standards: A scoping review to identify any existing standards or suggestions for developing MG. (2) Study of current practice: We will analyse a sample of recently published MG articles and catalogue the methods used for developing MG. (3) Interviews with MG users: We will conduct interviews with recent users of selected MG articles to elicit their views on strengths, weaknesses, and opportunities for improvement. (4) Development of STREAM: A panel of guidance developers and users from academia and industry will draft an initial version of STREAM and apply consensus methods. The panel will consider the findings from studies 1-3 and processes for developing other types of guidance, such as reporting guidelines and clinical practice guidelines. (5) Testing and refining STREAM: Guidance developers will apply the draft STREAM to ongoing MG development projects and provide feedback that will inform the final version. Results STREAM will be a comprehensive, evidence-informed, user-centred, and practice-tested instrument for creating MG. It will provide practical recommendations for MG developers on involving relevant interest-holders, selecting and using methodological evidence, translating evidence into recommendations, and presenting guidance in a clear and implementable format. Plain Language Summary Health researchers need clear and trustworthy guidance to help them plan, conduct, analyse, and interpret their studies. The guidance should ensure that the research is valid and genuinely beneficial to patients. However, there is currently uncertainty about the ways for creating this guidance. As a result, experts often develop guidance in an unstructured way or are uncertain how to integrate existing evidence or the views of health researchers who are the intended users of the guidance. This may undermine trust in the guidance, making it less helpful than it could be. Our goal is to address this. We aim to provide a process, STREAM, for creating trustworthy and user-friendly guidance that leads to meaningful and valid health research. Here is our plan: (1) Review existing suggestions for creating guidance: We will analyze existing publications that make suggestions on how to create guidance. (2) Review existing guidance: We will analyse a sample of recent guidance to see how experts currently create guidance: for example, how they collected information, involved users, reached a consensus, and tested the guidance. (3) Engage with guidance users: We will interview health researchers who recently used guidance. We want to understand what makes guidance trustworthy and meaningful to them. (4) Develop STREAM: We will assemble a diverse group including experts and health researchers. Together, we will develop the new process, STREAM. (5) Test STREAM: We will collaborate with experts currently creating guidance and ask them to test the new process. We will collect feedback to refine and finalize STREAM. To ensure that our research makes sense, we will consider possibilities for engaging health researchers, patients, and members of the public throughout the projects. In summary, our aim is to provide practical advice for experts who create guidance for conducting health research. We will call the new process STREAM and it will be evidence-based, user-centred, and practice-tested. STREAM will make it easier to create guidance that is clearer for health researchers and will lead to evidence that is more actionable and relevant to patients.
BACKGROUND AND OBJECTIVES:Methodological studies critically evaluate how health research is designed, conducted, analyzed, and reported. Despite their growing importance, currently, there is no reporting tailored to this type of research, which hampers the visibility, reproducibility, and overall utility of the findings of methodological studies. METHODS:We administered a survey to researchers with expertise in designing and performing methodological studies to gather their opinions on appropriate terminology, how they should be categorized, and key reporting elements. Quantitative data were analyzed descriptively, with a content validity ratio applied to determine appropriateness. Qualitative survey responses were analyzed using inductive content analysis. RESULT:Of 499 invited, a total of 119 participants completed the survey (response rate 23%). None of the 13 proposed nomenclatures met the threshold for appropriateness. Of the four proposed study categories, two (study aim and study design) were retained based on expert ratings. Among 23 proposed reporting items, 15 were endorsed for further evaluation. Qualitative responses were condensed and categorized, identifying the importance of flexibility in terminology and concerns about categorization. CONCLUSION:There is substantial disagreement among experts regarding key aspects of methodological studies, particularly related to terminology. While some agreement was observed around study categories and reporting elements, diverse and sometimes conflicting perspectives underscore the complexity of standardizing methodological studies. These findings reinforce the need for a collaborative consensus process to develop reporting guidance that is both practical and adaptable to the nuances of this field.
OBJECTIVES:Observational studies suggest that acid suppression may worsen outcomes among patients infected with SARS-CoV-2. The objectives of this embedded substudy of a randomised controlled trial evaluating pantoprazole in mechanically ventilated patients were to (1) describe the clinical characteristics of critically ill patients with SARS-CoV-2, (2) compare clinical outcomes with a propensity-matched non-infected cohort and (3) assess whether pantoprazole's treatment effects differed by SARS-CoV-2 infection status. DESIGN:A pre-planned substudy of the re-evaluating the inhibition of stress erosions (REVISE) trial, including a propensity-matched analysis of infected and non-infected patients comparing the effect of pantoprazole between patients with and without SARS-CoV-2. SETTING:68 intensive care units (ICUs) in eight countries. PARTICIPANTS:From July 2019 to October 2023, 4821 eligible participants were enrolled in REVISE whether or not they had SARS-CoV-2 infection. PRIMARY AND SECONDARY OUTCOME MEASURES:Participants enrolled in REVISE with SARS-CoV-2 infection had additional data collection, including biomarkers, venous thromboembolism, SARS-CoV-2 therapies and tracheostomy timing. The primary outcomes were clinically important upper gastrointestinal bleeding and 90-day mortality. Secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, patient-important upper GI bleeding, renal replacement therapy, ICU and hospital mortality and duration of mechanical ventilation, ICU and hospital stay. RESULTS:Of the eligible trial cohort, 11.9% (540/4550) had SARS-CoV-2; 532 patients had additional SARS-CoV-2-specific data collection. Of these 532 patients, 87.8% received COVID-19-directed treatments-(dexamethasone 75.2%), 11.7% developed pulmonary embolism and 9.2% developed deep-vein thrombosis. After propensity matching, SARS-CoV-2 infection was not associated with clinically important upper gastrointestinal bleeding (adjusted HR 0.78, 95% CI 0.40 to 1.50) but was associated with significantly higher ICU, hospital and 90-day mortality, as well as longer duration of ventilation and ICU and hospital length of stay. The effect of pantoprazole on clinically important upper GI bleeding and 90-day mortality was consistent regardless of SARS-CoV-2 status. CONCLUSIONS:SARS-CoV-2 infection was associated with higher mortality and longer duration of mechanical ventilation, ICU and hospital stays, without an increased risk of clinically important upper gastrointestinal bleeding. Pantoprazole reduced clinically important upper gastrointestinal bleeding without adversely affecting other outcomes. TRIAL REGISTRATION NUMBER:REVISE trial (NCT03374800), SARS-CoV-2 cohort study (NCT05715567).
Background: Retention in HIV care is associated with higher rates of antiretroviral treatment adherence and viral suppression, as well as lower risk of AIDS-related morbidity and mortality. However, the multidimensional nature of retention complicates measurement standardization, limiting comparability and global evaluation. This study explored how HIV stakeholders define and assess retention, aiming to develop a patient-centred and conceptually robust understanding to inform research and practice. Methods: We conducted a qualitative study using Interpretive Description (ID) methodology, an applied qualitative approach designed to generate practice-relevant knowledge in health research. We purposively sampled 20 stakeholders representing diverse areas of expertise and geographic regions across World Bank country income classifications. We conducted, video-recorded, and transcribed in-depth, semi-structured interviews. Using constant comparative analysis (CCA), we identified recurring, convergent, and contradictory patterns. Results: The analysis identified five overarching themes. The first two, exploratory themes, included: Patient-Centred Understanding of Retention in HIV Care, which captured how stakeholders conceptualized retention in their respective contexts, and Operationalization of Retention Measures, which explored the key components used to measure retention. The next two, explanatory themes, included Purpose-Driven Definitions of Retention, which described how retention measures were selected based on their intended use; and Building Capacity through Shared Understanding and Integrated Action, which emphasized retention as a cyclical, interconnected process dependent on collaboration between patients and health systems. The final, prescriptive theme, Advancements Shaping Retention, reflected stakeholders' shared vision of improving retention through innovations in HIV treatment and technology. Conclusions: The findings suggest that stakeholders operationalize retention measures in line with specific objectives and individual health goals, while remaining attentive to contextual realities. Retention measures should remain flexible and patient-centred, rather than relying on a single rigid standard. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study has received no funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Hamilton Integrated Research Ethics Board approved this study, including all communication protocols (HiREB #16500). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The qualitative data generated during this study are not publicly available due to ethical restrictions and confidentiality agreements with participants. The interview guide is available as supplementary material.
INTRODUCTION:Health researchers benefit from methods guidance (MG) for planning, conducting, analyzing and interpreting research studies. How to develop MG that is trustworthy and researcher-friendly is unclear; existing strategies for developing MG are fragmented and lack a coherent framework. The STrategies for developing REseArch Methods guidance (STREAM) project aims to provide such a framework for developers of MG. As a first step, we reviewed the literature to identify proposed and applied strategies for developing MG and explored possible knowledge gaps. METHODS:We conducted two literature reviews. First, a scoping review of the methodological literature to identify proposed strategies for developing MG. Second, a review of a purposeful sample of recently published MG articles to examine strategies applied in practice. We applied a qualitative content analysis to both sets of publications using one shared codebook. In addition, to identify possible knowledge gaps, we contrasted the findings with the established development processes for clinical practice guidelines and reporting guidelines. RESULTS:The first review included 17 publications and the second review 102 MG articles. We identified possible development steps including assessing the need for MG, establishing a working group, considering the findings from methodological studies, gathering input from interest-holders, testing the new MG, and disseminating and implementing MG. In addition, we identified various approaches to perform the steps including systematic reviews of previous guidance, reviews of methodological practice, simulation studies, surveys or interviews of interest-holders, consensus methods, and public review. Mapping these findings with established development processes identified areas that have so far received limited attention within MG development, including considering evidence from methodological research, judging the certainty of this evidence, reporting of MG, and approaches to implementation. CONCLUSION:This study provides an overview of proposed and applied strategies for developing MG, highlights needs for conceptual development, and provides a structured starting point for guidance for developing MG. PLAIN LANGUAGE SUMMARY:Almost every method used in health research comes with its own guidance - sets of advice and suggestions on how to plan and carry out the research, as well as helping with the analysis and interpretation of the results. When this guidance is clear and can be trusted, it helps researchers produce evidence that is valid and useful. However, the process for developing such guidance is currently unclear. The aim of this project called STrategies for developing REseArch Methods guidance (STREAM)is to create a framework for developing trustworthy, and user-friendly methods guidance. In this manuscript, we report on two literature reviews that will inform the new strategies. In the first, we looked for existing publications that suggest strategies for developing methods guidance. Secondly, we examined recently published methods guidance articles to see how they were developed. We also compared our findings with established development processes for other kinds of guidance: clinical practice guidelines and reporting guidelines. As a result, we found many possible and complementary strategies for developing methods guidance: forming a working group, reviewing previous research; seeking input from interest-holders; testing the guidance; and actively supporting dissemination and use. We also identified important areas where further research is needed. For example, we found that it is currently unclear how previous research should inform methods guidance or how to optimally present it. In summary, our reviews identified various possible strategies for developing methods guidance but also important gaps that the framework for developing methods guidance should address.
Abstract Background Sustained retention in care supports continuous access to antiretroviral therapy, routine clinical monitoring, and long-term viral suppression. Objective To compare the effectiveness of interventions for improving retention in care among people living with HIV (PLHIV). Design Systematic review and network meta-analysis Data sources PubMed, Embase, CINAHL, PsycINFO, Web of Science, and the Cochrane Library from 1995 to December 2024. Eligibility criteria Randomised controlled trials (RCTs) evaluating interventions to improve retention in care, viral load suppression, or quality of life (QoL) among PLHIV, compared with standard of care (SoC) or other interventions. Data extraction and synthesis Pairs of reviewers independently screened studies, extracted data, and assessed risk of bias using ROBUST-RCT. We conducted a fixed-effect frequentist network meta-analysis and rated interventions categories relative to SoC based on effect estimates effects and the certainty of evidence.. Dichotomous outcomes were summarized as odds ratios (ORs) with 95% confidence intervals (CIs), and continuous outcomes as mean differences (MDs) with 95% CI. Results Eighty-four trials enrolling 107 137 PLHIV evaluated 13 intervention categories. For retention in care, five interventions supported by moderate or high certainty evidence proved superior to SoC: multi-month dispensing (OR 2.02, 95% CI 1.32 to 3.09), task shifting (OR 1.94, 95% CI 1.42 to 2.66), differentiated service delivery (OR 1.47, 95% CI 1.22 to 1.76), behavioural counselling (OR 1.36, 95% CI 1.21 to 1.54), and supportive interventions (OR 1.31, 95% CI 1.11 to 1.55). For viral load suppression, two interventions supported by moderate or high certainty evidence proved superior to SoC: task shifting (OR 2.07, 95% CI 1.25 to 3.43) and behavioural counselling (OR 1.34, 95% CI 1.11 to 1.67). Across outcomes, no intervention demonstrated convincing superiority over other active interventions. Conclusions Among 13 intervention categories, only a subset provided moderate or high-certainty evidence of superiority to the standard of care, and no superiority to other interventions. Persistent evidence gaps for key populations, diverse settings, and long-term outcomes support the need for context-sensitive and patient-centred interventions. Registration PROSPERO CRD42024589177 Strengths and limitations of this study ➢ This systematic review followed Cochrane methods and was reported in accordance with PRISMA-NMA guidelines. ➢ The network meta-analysis integrated direct and indirect evidence to compare multiple intervention categories within a single framework. ➢ Risk of bias and certainty of evidence were assessed using ROBUST-RCT and the GRADE approach for network meta-analysis, respectively. ➢ Some networks were sparse, and limited representation of key populations and long-term follow-up constrained the strength and generalisability of inferences.
Background: Older adults with acute myeloid leukemia (AML) represent a cancer population in which disease-based risk factors, comorbidities, patient goals, and treatment risks and benefits influence treatment recommendations. Objective: These evidence-based guidelines from the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health professionals in their decisions about management of AML in older adults. Methods: ASH formed a multidisciplinary guideline panel, including patient representatives, that minimized bias from conflicts of interest. Clarity Research Group at McMaster University supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized questions and outcomes according to their importance for clinicians and patients. The panel used the grading of recommendations assessment, development and evaluation approach, including evidence-to-decision frameworks, to assess evidence and make recommendations. Results: The panel agreed on 9 critical clinical recommendations for managing AML in older adults, mirroring real-time practitioner-patient conversations: the decision to pursue antileukemic treatment vs best supportive management; traditional induction and postremission therapy vs hypomethylating agent or low-dose cytarabine, or combinations with venetoclax; the role and duration of postremission therapy; combinations with venetoclax vs monotherapy; the use of targeted therapy, including isocitrate dehydrogenase and FMS-like tyrosine kinase 3 (FLT3) inhibitors, in appropriate patients; the role of hematopoietic stem cell transplantation in nonfavorable prognosis AML; and the role of transfusion support for patients no longer receiving antileukemic therapy. Conclusions: Key recommendations of these guidelines include treatment over best supportive care; venetoclax-based regimens over monotherapies; and incorporation of FLT3 inhibitors into traditional induction and postremission therapy.
To support evidence-based healthcare appropriately, clinical practice guidelines must reflect what matters most to patients. This requires considering health outcomes that patients value, such as pain, function, or quality of life. These outcomes are captured by researchers using patient-reported outcomes (PROs). Despite their relevance, PROs remain inconsistently used in guideline development.This article provides an example-based roadmap for integrating PROs into the development of clinical practice guidelines. We define key concepts, explain how to design good recommendation questions, and describe strategies to summarize and interpret data about PROs, including how to handle studies that use diverse instruments and inconsistent reporting. Additionally, we describe how to use this information when judging the balance between benefits and harms and assessing certainty of evidence to support transparent recommendations.We emphasize that integrating PROs throughout the guideline process increases the likelihood that recommendations are aligned with patient values. Achieving this goal also requires high-quality primary studies and systematic reviews that include and report on PROs.
Evidence-based decision making in health often requires comparison of multiple options for a given condition. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) evidence-to-decision (EtD) framework provides a structured approach for moving from evidence to decisions but was originally designed for pairwise comparisons. Hence, there is a need to accommodate decision making based on multiple comparisons, especially with the increasing use of systematic reviews and network meta-analyses in guideline development. Furthermore, since the original EtD framework was developed, further relevant GRADE guidance has been developed. The aim of this work was to develop a new EtD framework to accommodate multiple comparisons and reflect current GRADE guidance. The new EtD framework was revised and developed through iterative discussion, feedback, and refinement by the GRADE EtD Project Group and the GRADE Working Group. Experiences and examples from guideline developers, methodological experts, and other stakeholders informed improvements in its structure and usability for multiple comparisons and were subsequently approved by the GRADE Working Group. This article describes the new EtD framework, which now includes 2 corresponding parts for reviews of pairwise and multiple comparisons. The authors describe application to a review with multiple comparisons for the different parts of the EtD framework: the question definition, which now includes the presentation of values of health outcomes and decision thresholds; the assessment section, where the new "net effect" criterion has been included; and the conclusion section, which includes an adaptation for multiple comparisons. The article provides examples and suggestions for presentation of findings. The framework does have limitations, in that its usability has not been tested across a broad spectrum of guideline development contexts.
Background:Coronary artery disease (CAD) remains a leading cause of global mortality and disability. CAD patients face tradeoffs between antithrombotic therapy benefits and bleeding risks, underscoring the need to incorporate patient values and preferences into clinical guidelines. Establishing minimal important differences (MIDs) for patient-important outcomes supports clinical guideline development by determining the smallest change in outcomes that patients consider important. However, directly conducting patient surveys to establish MIDs presents several methodological challenges. Methods:We established a multidisciplinary working group to guide the MID investigation. Using a three-phase process, we identified key outcomes through literature review and discussion. We will develop draft health outcome descriptions by synthesizing evidence from clinical guidelines and qualitative studies, supplemented with patient interviews, and refine the drafts through iterative cognitive interviews. We then designed outcome-specific draft MID questionnaires and will employ cognitive interviews to assess clarity and comprehensibility. Discussion:This study will develop standard materials for surveying patient values and determining MIDs in Chinese CAD patients. The resulting methodology will support future investigations into patient-important outcomes and provide critical evidence for clinical guideline development.
Background Retention in HIV care is associated with higher rates of antiretroviral treatment adherence and viral suppression, as well as lower risk of AIDS-related morbidity and mortality. However, the multidimensional nature of retention complicates measurement standardisation, limiting comparability and global evaluation. Objectives This study explored how HIV stakeholders define and assess retention, aiming to develop a patient-centred and conceptually robust understanding to inform research and practice. Methods We conducted a qualitative study using interpretive description methodology, an applied qualitative approach designed to generate practice-relevant knowledge in health research. We purposively sampled 20 stakeholders representing diverse areas of expertise and geographic regions across World Bank country income classifications. We conducted and video-recorded in-depth semistructured interviews and subsequently transcribed them. Using constant comparative analysis, we identified recurring, convergent and contradictory patterns. Results The analysis identified five overarching themes. The first two, exploratory themes, included Patient-Centred Understanding of Retention in HIV Care, which captured how stakeholders conceptualised retention in their respective contexts and Operationalisation of Retention Measures, which explored the key components used to measure retention. The next two explanatory themes, included Purpose-Driven Definitions of Retention, which described how retention measures were selected based on their intended use, and Building Capacity through Shared Understanding and Integrated Action, which emphasised retention as a cyclical, interconnected process dependent on collaboration between patients and health systems. The final, prescriptive theme, Advancements Shaping Retention, reflected stakeholders’ shared vision of improving retention through innovations in HIV treatment and technology. Conclusions The findings suggest that stakeholders operationalise retention measures in line with specific objectives and individual health goals, while remaining attentive to contextual realities. Retention measures should remain flexible and patient-centred, rather than relying on a single rigid standard.
OBJECTIVES:The reporting of patient-important outcomes (PIOs) in randomized controlled trials (RCTs) for COVID-19 varies widely, limiting their application in clinical decision-making. We evaluated how often PIOs were reported as primary outcomes in RCTs of COVID-19 treatments and identified trial characteristics associated with their reporting. STUDY DESIGN AND SETTING:This meta-epidemiological study analyzed primary outcome data from 102 RCTs evaluating COVID-19 treatments. RESULTS:Mortality outcomes were more frequently reported in trials with 15- to 28-day follow-up than in trials with ≤14-day follow-up (OR: 3.53, 95% CI: 1.10-11.38), and less frequently in trials enrolling participants with moderate-severity COVID-19 compared with trials not enrolling such participants (odds ratio [OR]: 0.22, 95% confidence interval [CI]: 0.07-0.64). Morbidity outcomes were less frequently reported in trials enrolling severe-COVID-19 participants compared with trials not enrolling them (OR: 0.19, 95% CI: 0.05-0.78), and more frequently reported in trials conducted in Europe (OR: 12.78, 95% CI: 1.01-161.76), Asia (OR: 11.03, 95% CI: 1.50-81.03) and the Americas (OR: 8.92, 95% CI: 1.08-73.89), each compared with multicontinental trials. Trials with more than 200 participants were also more likely to report morbidity outcomes than trials with ≤50 participants (OR: 11.43, 95% CI: 1.37-95.55). Quality of life and functional status outcomes were not associated with any of the predictors examined. CONCLUSIONS:Reporting of PIOs as primary outcomes in COVID-19 RCTs is inconsistent and influenced by region, disease severity, and sample size. Quality of life and functional recovery remain overlooked. The implementation of core outcome sets) is required to ensure that PIOs are routinely and consistently incorporated into trial designs. PLAIN LANGUAGE SUMMARY:Clinical trials should measure outcomes that matter most to patients, such as survival and quality of life. We investigated whether COVID-19 trials prioritized these outcomes as their main goals. We analyzed 102 COVID-19 trials and found that while survival and clinical complications were frequently measured, quality of life and long-term recovery were rarely used as primary goals. The choice of what to measure was often influenced by the trial's location or size rather than patient needs. The lack of focus on quality of life limits the ability of trials to inform decisions that reflect what patients truly value. Future research should use standardized "patient-important outcomes" to ensure clinical trials remain relevant to the people they intend to help.
We performed a systematic review meta-analysis to inform the development of a multi-society guideline on the management of diverticular disease. We identified randomized trials and cohort studies addressing five key questions for patients with symptomatic uncomplicated diverticular disease (SUDD), uncomplicated diverticulitis, and complicated diverticulitis. Our panel established outcomes and decision thresholds. Two reviewers performed screening by title and abstract and full-text, data extraction, and risk of bias appraisal. We applied a random-effects meta-analysis and appraised the certainty of the evidence per GRADE. We identified 27 studies from 5,449 articles. For KQ3, patients with recurrent symptomatic uncomplicated diverticulitis experienced an improvement in quality of life at 2 years [standardized mean difference of 0.53, 95