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Although medical information is essential for all patients, information needs and information processing capacities vary between individual patients and over time and context, within patients. Therefore, it is often recommended to "tailor" medical information to individual patients during clinic visits. However, there is a lack of consensus on what "tailoring" in clinical interactions represents since the definitions provided in the literature thus far generally regard tailoring of written text, rather than in dialogue during face-to-face interactions. To provide clinicians with guidance on how to tailor information to individual patients and to allow researchers to assess the effectiveness thereof, clarity is urgently needed regarding what "tailoring" actually means and what it entails in practice. In this paper we outline the current challenges of applying the concept of "tailoring" to the clinical setting and present existing definitions. Importantly, we introduce a new working definition of the concept that encompasses essential informational and dialogic components. We believe this provisional definition promotes much-needed conceptual precision in how communication researchers and educators define and assess tailored information provision in clinical consultations., Competing Interests: Declaration of Competing Interest All authors (E. Smets, J. Menichetti, H. Lie and J. Gerwing) declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background and Aims: Inadequate reporting of smoking cessation intervention trials is common and leads to significant challenges for researchers. The aim of this study was to tailor CONSORT (Consolidated Standards of Reporting Trials)-SPI (Social and Psychological Interventions) guidelines to improve reporting of trials of behavioural interventions to promote smoking cessation., Method: Informed by missing data from the IC-SMOKE (Intervention and Comparison group support provided in SMOKing cEssation) systematic review project, this study used a multi-stage Delphi process to examine which items could be added or modified to improve the reporting of smoking cessation trials. The first stage involved an on-line survey of 17 international experts in smoking cessation and trial methodology voting on the importance of items for inclusion in the updated guidelines. This was followed by a face-to-face expert consensus meeting attended by 15 of these experts, where the final inclusion and exclusion of new items and modifications were agreed upon. A nine-point Likert scale was used to establish consensus, with suggested modifications requiring agreement of 75% or more. Disagreements in the first stage were presented again at the second stage for discussion and a second round of voting. Only items which reached the threshold for agreement were included., Results: The experts agreed on the inclusion of 10 new items and the specification of 12 existing items. This included modifications that could apply to trials more widely (e.g. the rationale for the comparator), but also modifications that were very specific to smoking cessation trials (e.g. the reporting of smoking cessation outcomes)., Conclusions: A Delphi study has developed a modified CONSORT-SPI guideline (CONSORT-SPI-SMOKE) to improve the reporting of trials of behavioural interventions to promote smoking cessation., (© 2023 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Background: To enhance perioperative outcomes, a perioperative registry that integrates high-quality real-world data throughout the perioperative period is essential. Singapore General Hospital established the Perioperative and Anesthesia Subject Area Registry (PASAR) to unify data from the preoperative, intraoperative, and postoperative stages. This study presents the methodology employed to create this database., Methods: Since 2016, data from surgical patients have been collected from the hospital electronic medical record systems, de-identified, and stored securely in compliance with privacy and data protection laws. As a representative sample, data from initiation in 2016 to December 2022 were collected., Results: As of December 2022, PASAR data comprise 26 tables, encompassing 153,312 patient admissions and 168,977 operation sessions. For this period, the median age of the patients was 60.0 years, sex distribution was balanced, and the majority were Chinese. Hypertension and cardiovascular comorbidities were also prevalent. Information including operation type and time, intensive care unit (ICU) length of stay, and 30-day and 1-year mortality rates were collected. Emergency surgeries resulted in longer ICU stays, but shorter operation times than elective surgeries., Conclusions: The PASAR provides a comprehensive and automated approach to gathering high-quality perioperative patient data.

Background: Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community., Methods: The PRIMORANT study had three phases. First, an initial workshop was held to scope the issues faced by trialists when considering whether to use HSDs for trial outcomes. Second, a consultation exercise was undertaken with clinical trials unit (CTU) staff, trialists, methodologists, clinicians, funding panels and data providers. Third, a final discussion workshop was held, at which the results of the consultation were fed back, case studies presented, and issues considered in small breakout groups., Results: Key topics included in the consultation process were the validity of outcome data, timeliness of data capture, internal pilots, data-sharing, practical issues, and decision-making. A majority of consultation respondents (n = 78, 95%) considered the development of guidance for trialists to be feasible. Guidance was developed following the discussion workshop, for the five broad areas of terminology, feasibility, internal pilots, onward data sharing, and data archiving., Conclusions: We provide guidance to inform decisions about whether or not to use HSDs for outcomes, and if so, to assist trialists in working with registries and other HSD providers to improve the design and delivery of trials., (© 2024. The Author(s).)

Background/aims: Socioeconomic status (SES) is associated with late disease presentation and poorer outcomes. We evaluate the effect of SES on treatment outcomes and report the correlation between SES and baseline characteristics of participants in the Treatment of Advanced Glaucoma Study., Methods: Pragmatic multicentre randomised controlled trial. Four hundred and fifty-three patients presenting with advanced open-angle glaucoma in at least one eye (Hodapp-Parrish-Anderson classification). Participants were randomised to either glaucoma drops (medical arm) or trabeculectomy (surgery arm). Clinical characteristics, Quality of life measurement (QoL) and SES defined by the Index of Multiple Deprivation are reported. Subgroup analysis explored treatment effect modifications of SES at 24 months. Correlation between SES and baseline characteristics was tested with the χ 2 test of association for dichotomous variables and pairwise Pearson's correlation for continuous variables., Results: The mean visual field mean deviation was -17.2 (6.7)dB for the most deprived quintile of participants and -13.0 (5.5) for the least deprived quintile in the index eye. At diagnosis, there was a strong correlation between SES and ethnicity, age, extent of visual field loss and number of visits to opticians prior to diagnosis. At 24 months, there was no evidence that the treatment effect was moderated by SES., Conclusions: In patients presenting with advanced glaucoma. SES at baseline is correlated with poorer visual function, poorer Visual Function Questionnaire-25 QoL, ethnicity, age and number visits to an optician in the years preceding diagnosis. SES at baseline does not have an effect of the success of treatment at 24 months., Trial Registration Number: ISRCTN56878850., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

There are free, evidence-based Digital Health Interventions (DHIs) that can help children's mental health, but few parents use them. We sought to understand what influenced uptake of DHIs by parents of children aged 2-12 years old with a mental health problem. We interviewed parents and analysed data using inductive content analysis. Four factors emerged: i) personal capacity; ii) awareness of DHIs and where to find one; iii) credibility, including trust and endorsement from experts; and iv) the suitability of a DHI to their child's specific problem and level of need. Incorporating these themes into the design of future DHIs may improve uptake.

Patient safety research has focused mostly on the hospital and acute care setting whereas assessments of patient safety climate in primary health care settings are warranted. Valid questionnaires as e.g., the Safety Attitudes Questionnaire (SAQ) may capture staff perceptions of patient safety climate but until now, an overview of the use of SAQ in primary care has not been systematically presented. Thus, the aim of this systematic review is to present an overview of SAQ used in primary care.Methods The electronic databases: PubMed, Embase, Cinahl, PsycInfo and Web of Science were used to find studies that used any version of SAQ in primary care. Studies were excluded if only abstract or poster was available, as the information in abstract and posters was deemed insufficient. Commentaries and nonempirical studies (e.g., study protocols) were excluded. Only English manuscripts were included.Results A total of 43 studies were included and 40 of them fell into four categories: 1) validation analysis, 2) descriptive analysis, 3) variance assessment and 4) intervention evaluation and were included in further analyses. Some studies fell into more than one of the four categories. Seventeen studies aimed to validate different versions of SAQ in a variety of settings and providers. Twenty-five studies from fourteen different countries reported descriptive findings of different versions of SAQ in a variety of settings. Most studies were conducted in primary health care centres, out-of-hours clinics, nursing homes and general practice focusing on greatly varying populations. One study was conducted in home care. Three studies investigated variance of SAQ scores. Only five studies used SAQ to assess the effects of interventions/events. These studies evaluated the effect of electronic medical record implementation, a comprehensive Unit-based Safety Program or COVID-19.Conclusion The synthesis demonstrated that SAQ is valid for use in primary care, but it is important to adapt and validate the questionnaire to the specific setting and participants under investigation. Moreover, differences in SAQ factor scores were related to a variety of descriptive factors, that should be considered in future studies More studies, especially variance and intervention studies, are warranted in primary care.Trial registration This systematic review was not registered in any register., (© 2024. The Author(s).)

Background: For the potential benefits of trials to reach all that they should, trials must be designed to ensure that those taking part reflect the population who will receive the intervention. However, adults with impaired capacity to consent are frequently excluded from trials - partly because researchers are unfamiliar with the legal and ethical frameworks and lack the necessary methodological expertise. Researchers identified a need for guidance on designing more inclusive trials. Building on the NIHR INCLUDE initiative, we developed the INCLUDE Impaired Capacity to Consent Framework to help researchers design inclusive trials., Methods: The framework was developed over five phases: (1) establishing the scope and content of the framework and adapting the INCLUDE Ethnicity Framework for this population; (2) scoping the relevance of the framework to different populations and piloting in a range of trials; (3) consulting people living with impairing conditions and carers to explore their views about the framework and identify missing content areas; (4) refining the framework; and (5) the development of an implementation toolkit of resources to support researchers using the framework., Results: The framework has two parts: a set of four key questions to help researchers identify who should be included in their trial, and a series of worksheets covering intervention design, recruitment and consent processes, data collection and analysis, and public involvement and dissemination. It is supported by a summary of the ethical and legal frameworks and a website of resources on capacity and consent. Implementation resources include infographics and animations, a library of completed frameworks, and facilitated workshops for researchers. The framework and toolkit were launched at a webinar (November 2022), with polling demonstrating an increase in attendees' awareness about research involving adults lacking capacity. A post-webinar survey found that stakeholders viewed the framework and toolkit as valuable tools to facilitate greater inclusion of this under-served population in trials. The framework is available online: https://www.capacityconsentresearch.com/include-impaired-capacity-to-consent-framework.html ., Conclusions: The INCLUDE Impaired Capacity to Consent Framework and implementation toolkit can support researchers to design more inclusive trials and other types of research studies. Further engagement, including with funders who are key to ensuring uptake, and evaluation is needed., (© 2024. The Author(s).)

Introduction: Emergency department (ED) admissions for non-work-related injuries and illnesses in the migrant worker (MW) population in Singapore are not well studied. We aimed to examine ED triage acuity and bills associated with admissions among MW for non-trauma, workplace injury (WI) trauma, and non-workplace injury (NWI) trauma., Methods: In this retrospective observational study, we included all work permit holders admitted to hospital via the ED of three public hospitals from 1 May 2016 to 31 October 2016. Data obtained from medical records included demographics, triage acuity and bill information., Results: There were 1,750 unique patients accounting for 1,788 admissions. The median age was 33 (interquartile range 27-40) years, with a male predominance of 67%. Trauma accounted for 33% ( n = 595) of admissions, and of these, 73% ( n = 433) were due to WI. Admissions for NWI, as compared to WI, were more likely to present as high acuity P1 cases (43% vs 24%, P < 0.001), be conveyed by ambulance (49% vs 24%, P < 0.001) and result in trauma team activations (29% vs 7%, P < 0.001). More NWI admissions (22%, 36/162) exceeded the insurance claim limit under prevailing healthcare policies, as compared to WI admissions (3%, 13/433)., Conclusion: Migrant workers are admitted to hospital for non-trauma conditions more frequently than for trauma. Non-workplace injury trauma may be severe. Non-trauma and NWI admissions can result in large bills that exceed mandatory insurance coverage. Recent changes to healthcare policy governing MW to allow copayment of large bills and better access to primary care are timely., (Copyright © 2024 Copyright: © 2024 Singapore Medical Journal.)

Introduction: This study aimed to assess whether two established psychosocial predictors of smoking abstinence, nicotine dependence and time-discounting, also apply to a population of predominantly cigarette light smokers, which is the dominant pattern of smoking in countries like Mexico. Relatively infrequent smoking is increasingly prevalent, yet still harmful, making it important to understand the predictors of cessation in this population., Aims and Methods: Mexican adult smokers recruited from an online consumer panel were surveyed every 4 months between November 2018 and July 2020. We considered respondents who reported a quit attempt in between surveys (n = 1288). Dependence was measured with a 10-item version of the Wisconsin Inventory of Smoking Dependence Motives (WISDM). Time-discounting was assessed with five branching questions about hypothetical reward scenarios. Logistic models regressed sustained quit attempts (≥30 days of abstinence) at time t + 1 on study variables at time t., Results: We found strong interitem reliability (α = 0.92) and intraindividual consistency of our brief WISDM (ρ = 0.68), but moderate intraindividual consistency of the time-discounting measure (ρ = 0.48). Forty-eight percent of the sample reported sustained quit attempts, and 79% were non-daily or light daily smokers (≤5 cigarettes per day). Smokers with higher WISDM-10 had lower odds of sustained quitting and this result remained when controlling for smoking frequency and the Heaviness of Smoking Index (adjusted odds ratio [AOR] = 0.768). Time-discounting was unassociated with sustained quitting., Conclusions: Our findings suggest that a brief, 10-item multidimensional measure of dependence is useful for predicting sustained quitting in a context of relatively light smoking; time-discounting appears less relevant, although our results are not conclusive because of the low test-retest reliability of our measure., Implications: Given the increase in non-daily and light daily cigarette smoking in many countries, including in Mexico, and the health risks this still poses, it is important to understand the predictors of cessation among relatively light smokers. The WISDM-10 multidimensional measure seems to be a good instrument to assess dependence and predict successful quitting in this population, and possibly more appropriate than physical dependence measures. As such, it could help design and target more suitable cessation treatments for non-daily and daily light cigarette smokers. While this study did not find time-discounting to be a relevant predictor of smoking abstinence, future studies should explore other measures., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Vision loss has been associated with mental health problems such as depression, anxiety, and post-traumatic stress disorder, which significantly impact lives of working age adults with adventitious total bilateral blindness and low vision. It is imperative, therefore, to prioritize the mental health in this population by exploring and understanding the factors that impact on their mental health. Hence, the objective of this scoping review is to identify and chart existing literature on the protective and risk factors of mental health of working age adults with adventitious total bilateral blindness and low vision. We developed this scoping review protocol in line with the Joanna Briggs Institute guidance. This scoping review will include publications in English language with no date restrictions exploring the protective and risk factors of mental health of our study population. A three-step search strategy will be employed. Searches will be carried out in the following databases: Medline, Embase, PsycInfo, PsycArticles, CINAHL and Web of Science. Search for grey literature will be conducted in Google, Google Scholar and Websites dedicated to information on visual impairment. Collated results will be imported into Endnote Basic (Clarivate) for deduplication. Two reviewers will independently conduct double screening of all the titles and abstracts in Rayyan- a web application, and full texts in Endnote while three other reviewers will conduct screening of a subset of for example 10% of titles and abstracts and full texts. Furthermore, two reviewers will independently conduct double data extraction while three other reviewers will revise, cross check, and correct any extraction errors. Extracted data will be presented in tabular formats and summarized descriptively in line with the research objectives. This scoping review will generate evidence on factors impacting the mental health of the working age adults with adventitious total bilateral blindness and low vision as well as critically highlight gaps in the literature. The findings will inform and critically underpin future empirical research which will explore the lived experiences of working age people with adventitious total bilateral blindness. Additionally, evidence from this review will inform the development of interventions in the promotion of mental health as well as assisting rehabilitation specialists and workers, public health practitioners and other relevant stakeholders in addressing the mental health needs of working age adults with adventitious total bilateral blindness and low vision., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Dike et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Excessive and incorrect use of antibiotics contributes to the rise of antimicrobial resistance (AMR). Given that pharmacists act as final checkpoint before antibiotics is handled over to patients, they play a crucial role in promoting proper antibiotic use and ensuring treatment adherence. However, there is often a gap between the patients' needs and perceptions, and what the pharmacists provide. Improving pharmacists' training is essential for enhancing patient-centered care. The aim of this research was to evaluate the suitability of academic detailing (AD) for improving Norwegian pharmacists' knowledge and practice on adherence promoting counseling of antibiotic patients. Key insights from prior qualitative research regarding community pharmacists' position in promoting optimized antibiotic use were incorporated in a tailored AD program. The AD's suitability was evaluated using the validated "Provider Satisfaction with Academic Detailing" (PSAD) and "Detailer Assessment of Visit Effectiveness" (DAVE) instruments. Additionally, participants preferred knowledge updates method were assessed. Eighty-one of 86 visits completed PSAD (94% response rate). Satisfaction summary score for PSAD was 40.03 (of maximum 45) and scale summary score for DAVE 12.45 (of maximum 15). One-sample t -test (P < .001) indicated preference for AD over other knowledge update methods. This study confirmed that AD is a successful knowledge updating tool for improving adherence promoting counseling among Norwegian pharmacists. Future research should align practice change intentions with actions post-AD and evaluate patient impact., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Severe obesity is associated with increased risk of non-alcoholic fatty liver disease and cardiovascular disease. We hypothesized that liver fibrosis as quantified by the Enhanced Liver Fibrosis (ELF) test would be predictive of myocardial injury and fibrosis, expressed by higher concentrations of cardiac troponin T and I measured by high-sensitivity assays (hs-cTnT and hs-cTnI, respectively)., Material and Methods: We performed cross-sectional analyses of baseline data from 136 patients (mean age 45 years, 38 % male) with severe obesity participating in the non-randomized clinical trial Prevention of Coronary Heart Disease in Morbidly Obese Patients (ClinicalTrials.gov NCT00626964). Associations between ELF scores, hs-cTnT, and hs-cTnI concentrations were assessed using linear regression analysis., Results: ELF scores were associated with hs-cTnT in the unadjusted model (B 0.381, 95 % Confidence Interval [CI] 0.247, 0.514), but the association was attenuated upon adjustment for potential confounders (B -0.031, 95 % CI -0.155, 0.093). Similarly, for hs-cTnI, an observed association with ELF scores in the unadjusted model was attenuated upon adjustment for potential confounders ((B 0.432, 95 % CI 0.179, 0.685) and (B 0.069, 95 % CI -0.230, 0.367), respectively). Age, sex, hypertension, and estimated glomerular filtration rate were amongst the shared predictors of ELF score, hs-cTnT, and hs-cTnI that provided the univariable models with the highest R-squared and lowest Akaike Information Criterion values., Conclusions: Contrary to our hypothesis, ELF score did not predict myocardial injury and fibrosis, but we rather demonstrated an association between liver fibrosis and myocardial injury and fibrosis may be explained by shared risk factors of cardiovascular disease., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: T.O. has received honoraria from Roche Diagnostics, Abbott Laboratories, Bayer and CardiNor not related to the current work, and nonfinancial support from Novartis, ChromaDexSomaLogic, Abbott Diagnostics, and Roche Diagnostics via institution. K.M.A. is an Associate Editor of Clinical Biochemistry and Chair of the International Federation of Clinical Chemistry Committee on Clinical Application of Cardiac Bio-Markers, she has served on advisory boards for Roche Diagnostics, Siemens Healthineers and SpinChip, and has received honorarium for consultancy from CardiNor, honorarium for lecturing from Siemens Healthineers and Snibe Diagnostics, and research grants from Siemens Healthineers and Roche Diagnostics. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Importance: Patient safety interventions, like the World Health Organization Surgical Safety Checklist, require effective implementation strategies to achieve meaningful results. Institutions with underperforming checklists require evidence-based guidance for reimplementing these practices to maximize their impact on patient safety., Objective: To assess the ability of a comprehensive system of safety checklist reimplementation to change behavior, enhance safety culture, and improve outcomes for surgical patients., Design, Setting, and Participants: This prospective type 2 hybrid implementation-effectiveness study took place at 2 large academic referral centers in Singapore. All operations performed at either hospital were eligible for observation. Surveys were distributed to all operating room staff., Intervention: The study team developed a comprehensive surgical safety checklist reimplementation package based on the Exploration, Preparation, Implementation, Sustainment framework. Best practices from implementation science and human factors engineering were combined to redesign the checklist. The revised instrument was reimplemented in November 2021., Main Outcomes and Measures: Implementation outcomes included penetration and fidelity. The primary effectiveness outcome was team performance, assessed by trained observers using the Oxford Non-Technical Skills (NOTECH) system before and after reimplementation. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture was used to assess safety culture and observers tracked device-related interruptions (DRIs). Patient safety events, near-miss events, 30-day mortality, and serious complications were tracked for exploratory analyses., Results: Observers captured 252 cases (161 baseline and 91 end point). Penetration of the checklist was excellent at both time points, but there were significant improvements in all measures of fidelity after reimplementation. Mean NOTECHS scores increased from 37.1 to 42.4 points (4.3 point adjusted increase; 95% CI, 2.9-5.7; P < .001). DRIs decreased by 86.5% (95% CI, -22.1% to -97.8%; P = .03). Significant improvements were noted in 9 of 12 composite areas on culture of safety surveys. Exploratory analyses suggested reductions in patient safety events, mortality, and serious complications., Conclusions and Relevance: Comprehensive reimplementation of an established checklist intervention can meaningfully improve team behavior, safety culture, patient safety, and patient outcomes. Future efforts will expand the reach of this system by testing a structured guidebook coupled with light-touch implementation guidance in a variety of settings.

Background: Randomised controlled trials ('trials') are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted., Objectives: PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial., Design: A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously., Setting: Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible., Participants: Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom., Interventions: Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial., Main Outcome Measures: Number of host trials funded., Results: Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lessons learnt to guide others planning Studies Within A Trial, including involving patient and public involvement partners; prioritising and selecting strategies to evaluate and elements to consider when designing a Study Within A Trial; obtaining governance approvals; implementing Studies Within A Trial, including individual and co-ordinated Studies Within A Trials; and reporting Study Within A Trials., Limitations: The COVID-19 pandemic negatively impacted five Studies Within A Trial, being either delayed ( n  = 2) or prematurely terminated ( n  = 3)., Conclusions: PROMoting THE Use of Studies Within A Trial significantly increased the evidence base for recruitment and retention strategies. When provided with both funding and practical support, host trial teams successfully implemented Studies Within A Trial., Future Work: Future research should identify and target gaps in the evidence base, including widening Study Within A Trial uptake, undertaking more complex Studies Within A Trial and translating Study Within A Trial evidence into practice., Study Registration: All Studies Within A Trial in the PROMoting THE Use of Studies Within A Trial programme had to be registered with the Northern Ireland Network for Trials Methodology Research Study Within A Trial Repository., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment ; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information.

The social and behavioural determinants of COVID-19 vaccination have been described previously. However, little is known about how vaccinated people use and rate their health system. We used surveys conducted in 14 countries to study the health system correlates of COVID-19 vaccination. Country-specific logistic regression models were adjusted for respondent age, education, income, chronic illness, history of COVID-19, urban residence, and minority ethnic, racial, or linguistic group. Estimates were summarised across countries using random effects meta-analysis. Vaccination coverage with at least two or three doses ranged from 29% in India to 85% in Peru. Greater health-care use, having a regular and high-quality provider, and receiving other preventive health services were positively associated with vaccination. Confidence in the health system and government also increased the odds of vaccination. By contrast, having unmet health-care needs or experiencing discrimination or a medical mistake decreased the odds of vaccination. Associations between health system predictors and vaccination tended to be stronger in high-income countries and in countries with the most COVID-19-related deaths. Access to quality health systems might affect vaccine decisions. Building strong primary care systems and ensuring a baseline level of quality that is affordable for all should be central to pandemic preparedness strategies., Competing Interests: Declaration of interests Research for this Series paper was supported by grants to MEK and the QuEST Network from the Bill & Melinda Gates Foundation and the Swiss Federal Department of Foreign Affairs. This research was also supported by grants to CA and MEK from Merck Sharp & Dohme; to EGE and HHL from the Inter-American Development Bank; and to JO from the Taejae Foundation. The funders of the study had no role in study design or conduct, data collection, data management, data analysis, data interpretation, the writing of the Series paper, or the decision to submit the Series paper for publication., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Introduction and Hypothesis: The Variation in Surgical Technique study (VaST), demonstrated the large variation in surgical techniques used in native tissue (NT) anterior pelvic organ prolapse (POP) repairs. However, there are few comparative studies of different surgical techniques. This study was aimed at exploring whether surgical technique influenced the outcomes of NT anterior POP repairs., Methods: The surgical techniques of 22 consultant surgeons performing NT anterior POP repairs were filmed and categorised. These surgeons performed 809 anterior repairs within the PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trial (PROSPECT). Logistical regression models were used to determine the influence of the different surgical techniques on subjective and objective outcomes, using data collected during PROSPECT., Results: In adjusted multivariate linear regression models, fascial-flap repair was associated with an improved subjective outcome (POP-SS) compared with midline plication (β = -2.50 [-4.42 to -0.57]; p = 0.01). At 12 months, separate fascial defect repair was associated with a poorer objective outcome than midline plication (OR 6.06 [1.82-3.52], p = 0.006). At 24 months, deep dissection was associated with a poorer POP-SS than superficial dissection (0.32-2.60, p = 0.0). Continuous-locking closure of the skin was also associated with improved POP-SS compared with continuous non-locking closure (12 months: β = -1.94 [-3.42 to -0.45], p = 0.01)., Conclusion: Surgical technique may influence the outcome of native tissue anterior POP repairs. Our results should not change practice but inform future research; to develop methods of explicitly recording surgical techniques and allow confirmation of the effect of these aspects of technique on outcome., (© 2023. The Author(s).)

Background: Despite their documented efficacy, substantial proportions of patients discontinue antidepressant medication (ADM) without a doctor's recommendation. The current report integrates data on patient-reported reasons into an investigation of patterns and predictors of ADM discontinuation., Methods: Face-to-face interviews with community samples from 13 countries ( n = 30 697) in the World Mental Health (WMH) Surveys included n = 1890 respondents who used ADMs within the past 12 months., Results: 10.9% of 12-month ADM users reported discontinuation-based on recommendation of the prescriber while 15.7% discontinued in the absence of prescriber recommendation. The main patient-reported reason for discontinuation was feeling better (46.6%), which was reported by a higher proportion of patients who discontinued within the first 2 weeks of treatment than later. Perceived ineffectiveness (18.5%), predisposing factors (e.g. fear of dependence) (20.0%), and enabling factors (e.g. inability to afford treatment cost) (5.0%) were much less commonly reported reasons. Discontinuation in the absence of prescriber recommendation was associated with low country income level, being employed, and having above average personal income. Age, prior history of psychotropic medication use, and being prescribed treatment from a psychiatrist rather than from a general medical practitioner, in comparison, were associated with a lower probability of this type of discontinuation. However, these predictors varied substantially depending on patient-reported reasons for discontinuation., Conclusion: Dropping out early is not necessarily negative with almost half of individuals noting they felt better. The study underscores the diverse reasons given for dropping out and the need to evaluate how and whether dropping out influences short- or long-term functioning.

Disrespect in health care often persists despite firm commitments to respectful service provision. This conceptual paper highlights how the ways in which respect and disrespect are characterised can have practical implications for how well disrespect can be tackled. We stress the need to focus explicitly on disrespect (not only respect) and propose that disrespect can usefully be understood as a failure to relate to people as equals. This characterisation is consonant with some accounts of respect but sometimes obscured by a focus on respecting people's autonomy and dignity. Emphasising equality is consistent with connections patients draw between being (dis)respected and (in)equality. It readily accommodates microaggressions as forms of disrespect, helping to understand how and why experiences of disrespect may be unintentional and to explain why even small instances of disrespect are wrong. Our view of disrespect with an emphasis on equality strengthens the demand that health systems take disrespect seriously as a problem of social injustice and tackle it at institutional, not just individual levels. It suggests several strategies for practical action. Emphasising relational equality is not an easy or short-term fix for disrespect, but it signals a direction of travel towards an important improvement ambition., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Primary health care (PHC) is central to attainment of the Sustainable Development Goals, yet comparable cross-country data on key aspects of primary care have not been widely available. This study analysed data from the People's Voice Survey, which was conducted in 2022 and 2023 in 14 countries. We documented usual source of care across countries and examined associations of usual source of care with core PHC services, quality ratings, and health system confidence. We found that 75% of respondents had a usual source of care, and that 40% of respondents accessed usual care in the public sector at primary level. 44% rated their usual source of care as very good or excellent. Access to PHC-linked screenings and treatments varied widely within and across countries. Having any usual source of care was associated with higher take-up of preventive services, greater access to treatment including mental health services, and greater health system endorsement. Strengthening links between health system users and primary care providers could improve take-up of preventive care and increase user satisfaction with health system performance., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Aim: Stage III colon cancer is routinely treated with adjuvant chemotherapy, which causes significant short-term morbidity. Its effect on long-term quality of life (QoL) is poorly investigated. The aim of this study was to investigate long-term QoL after curative treatment for colon cancer and explore the impact of chemotherapy on general and disease-specific QoL., Method: All patients aged under 75 years operated on for colon cancer between 30 September 2007 and 1 October 2019 were identified by the Cancer Registry of Norway. Exclusion criteria were distant metastasis, recurrence, dementia and rectal/rectosigmoid cancer operation. The primary outcome measure was Gastrointestinal Quality of Life Index (GIQLI). Secondary outcome measures included the Short Form Health Survey (SF-36). To achieve balanced groups when assessing differences in outcome measures the analyses were weighted by inverse probability weights based on a multiple logistic regression model with prechosen confounders., Results: A total of 8627 patients were invited and 3109 responded (36% response rate). After exclusions 3025 patients were included, of whom 1148 (38%) had received adjuvant chemotherapy and 1877 (62%) had surgery alone, with mean follow-up of 75.5 versus 74.5 months, respectively. The GIQLI differed significantly between the groups [mean 111.0 (SD 18.4) vs. 115.6 (SD 17.8), respectively; mean difference: -4.6 (95% CI -5.9; -3.2); p < 0.001]. Those with the highest neurotoxicity exhibited the lowest GIQLI. The adjuvant chemotherapy group scored significantly lower in six of eight SF-36 domains compared with the surgery alone group. The main differences were found in social, physical and emotional function., Conclusion: Long-term QoL was significantly lower in patients who received adjuvant chemotherapy than in patients who did not. Neurotoxicity was closely related to reduced QoL in these patients. The low response rate limits the generalizability of the results., (© 2023 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.)

The premise of health as a human right in Latin America has been challenged by health system fragmentation, quality gaps, a growing burden of chronic disease, sociopolitical upheaval, and the COVID-19 pandemic. We characterised inequities in health system quality in Colombia, Mexico, Peru, and Uruguay. We did a cross-sectional telephone survey with up to 1250 adults in each country. We created binary outcomes in coverage, user experience, system competence, and confidence in the system and calculated the slope index of inequality by income and education. Although access to care was high, only a third of respondents reported having a high-quality source of care and 25% of those with mental health needs had those needs met. Two-thirds of adults were able to access relevant preventive care and 42% of older adults were screened for cardiovascular disease. Telehealth access, communication and autonomy in most recent visit, reasonable waiting times, and receiving preventive health checks showed inequalities favouring people with a high income. In Uruguay, inequality between government and social security services explained a substantial proportion of disparities in preventive health access. In other study countries, inequalities were also substantial within government and social security subsectors. Essential health system functions are unequal in these four Latin American countries., Competing Interests: Declaration of interests JMR declares having the role of assistant researcher at Cayetano Heredia University (San Martín de Porres, Peru). We declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: This study aimed to review bicycle-related injuries during the COVID-19 pandemic to assist with reinforcement or implementation of new policies for injury prevention., Methods: This is a retrospective descriptive analysis of injuries sustained during cycling for patients 18 years old and above who presented to Singapore General Hospital from January to June 2021. Medical records were reviewed and consolidated. Descriptive analyses were used to summarize patient characteristics, and differences in characteristics subgrouped by triage acuity and discharge status were analyzed., Results: The study included 272 patients with a mean age of 43 years and a male predominance (71.7%). Most presented without referrals (88.2%) and were not conveyed by ambulances (70.6%). Based on acuity category, there were 24 (8.8%) Priority 1 (P1) patients with 7 trauma activations, 174 (64.0%) and 74 (27.2%) P2 and P3 patients respectively. The most common injuries were fractures (34.2%), followed by superficial abrasion/contusion (29.4%) and laceration/wound (19.1%). Thirteen (4.8%) patients experienced head injury and 85 patients (31.3%) were documented to be wearing a helmet. The majority occurred on the roads as traffic accidents (32.7%). Forty-two patients (15.4%) were admitted with a mean length of stay of 4.1 d and 17 (6.3%) undergone surgical procedures. Out of 214 (78.7%) discharged patients, no re-attendances or mortality were observed. In the subgroup analysis, higher acuity patients were generally older, with higher proportions of head injuries leading to admission., Conclusion: Our study highlights significant morbidities in bicycle-related injuries. There is also a high proportion of fractures in the young healthy male population. Injury prevention is paramount and we propose emphasizing helmet use and road user safety., Competing Interests: Conflicts of interest: All authors have completed the ICMJE uniform disclosure form. The authors have no conflicts of interest to declare., (Copyright: © World Journal of Emergency Medicine.)

Background: Early diagnosis of type 1 diabetes in children is critical to prevent deterioration to diabetic ketoacidosis (DKA), a state where the body's insulin levels are critically low resulting in the use of fat for fuel and the accumulation of ketones. DKA is a life-threatening emergency where dehydration and cerebral oedema can quickly develop and lead to death. Despite treatment, DKA also has harmful impacts on cognition and brain development. Most children admitted to a hospital with DKA see their general practitioner in the week leading up to their admission. A delay in referral from general practice can result in delays in commencing lifesaving insulin therapy. Prior systematic reviews have explored publicity campaign interventions aimed at recognising type 1 diabetes earlier; however, no reviews have explored these interventions targeted at reducing the delay after presentation to the general practitioner. This systematic review aims to summarise interventions that target the diagnostic delay emerging from general practice and to evaluate their effectiveness in reducing DKA admissions., Methods: Six databases (Ovid (MEDLINE), Web of Science, EMBASE, CINAHL, Evidence-Based Medicine Reviews (EBMR) and Google Scholar) will be searched to identify studies exploring interventions to reduce diagnostic delay in children with type 1 diabetes, and hence DKA, in general practice. The primary outcome will be the number of DKA admissions to a hospital following a delay in general practice. The secondary outcome will be the behaviour of general practitioners with respect to urgent referral of children with type 1 diabetes. Title, abstract and full-text screening for exclusion and inclusion of publications will be completed by two independent reviewers. Any risks of bias within individual studies will be assessed by two independent reviewers, using the Risk Of Bias In Non-Randomized Studies of Interventions tool. Our confidence in the overall body of evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation., Ethics and Dissemination: The systematic review will be disseminated via publication and potentially in conference presentations. Ethics is not required for a systematic review of secondary data., Prospero Registration Number: CRD42023412504., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

When a research group has multiple retracted publications and/or research misconduct by a member is evident, there is a risk that its other publications are unreliable, so a comprehensive assessment of the group's publications is advisable. We analyzed the comprehensiveness of assessment of the integrity of 300 publications by a research group with numerous retractions and known research misconduct, for 292 of which we raised concerns to publishers and academic institutions between 3/2013 and 2/2020. By 4/2023, 91 (30%) publications had not been assessed by either publisher or academic institution. Publishers had assessed 185 (63%) publications. The 4 academic institutions had assessed 5/36 (14%), 56/216 (26%), 30/50 (60%) and 40/66 (61%) publications. Unprompted assessments, those undertaken without our notification of concerns, occurred for 24 (8%) publications, 3 (1%) by publishers and 21 (7%) by academic institutions. Among 32 journals with ≥2 affected publications, no unprompted assessments of the remaining publication(s) occurred after notification of concerns about the index publication(s). Publishers retracted 58/84 (69%) publications which institutions also assessed and decided needed no editorial action. These analyses demonstrate the failure of publishers and institutions to comprehensively and spontaneously determine the integrity of publications in a setting of known misconduct and multiple retractions.

Background: Medication lists prepared in the emergency department (ED) form the basis for diagnosing and treating patients during hospitalization. Since incomplete medication information may lead to patient harm, it is crucial to obtain a correct and complete medication list at hospital admission. In this cross-sectional retrospective study we wanted to explore medication information completeness in admission notes from Norwegian EDs and investigate which factors were associated with level of completeness., Methods: Medication information was assessed for completeness by applying five evaluation criteria; generic name, formulation, dose, frequency, and indication for use. A medication completeness score in percent was calculated per medication, per admission note and per criterion. Quantile regression analysis was applied to investigate which variables were associated with medication information completeness., Results: Admission notes for patients admitted between October 2018 and September 2019 and using at least one medication were included. A total of 1,080 admission notes, containing 8,604 medication orders, were assessed. The individual medications had a mean medication completeness score of 88.1% (SD 16.4), while admission notes had a mean medication completeness score of 86.3% (SD 16.2). Over 90% of all individual medications had information about generic name, formulation, dose and frequency stated, while indication for use was only present in 60%. The use of an electronic tool to prepare medication information had a significantly strong positive association with completeness. Hospital visit within the last 30 days, the patient's living situation, number of medications in use, and which hospital the patient was admitted to, were also associated with information completeness., Conclusions: Medication information completeness in admission notes was high, but potential for improvement regarding documentation of indication for use was identified. Applying an electronic tool when preparing admission notes in EDs seems crucial to safeguard completeness of medication information., (© 2023. The Author(s).)

Objectives: Over 40 million people in low-income and middle-income countries (LMICs) experience serious health-related suffering (SHS) annually and require palliative care. Patient and caregiver experiences of SHS in LMICs are understudied despite their importance in guiding palliative care provision. Diabetes and cancer are the second-leading and third-leading causes of death in Mexico, causing a significant SHS burden on patients, families and health systems. This study examines SHS and palliative care from the point of view of patients with cancer and diabetes and their caregivers., Design: A qualitative descriptive study based on in-depth telephone interviews was conducted between August 2021 and February 2022. Data were analysed through inductive thematic analysis., Participants: Overall, 20 patients with end-stage cancer, 13 patients with diabetes and 35 family caregivers were interviewed individually., Setting: Participants were recruited from two family medicine clinics and a pain clinic in Mexico City., Results: Seven themes emerged: (1) suffering as a multifaceted phenomenon, (2) diversity in perceptions of suffering, (3) different coping strategies, (4) need and perceived importance of relief from suffering, (5) barriers to accessing services to relieve suffering, (6) demand for the health sector's active and humane role in addressing suffering and (7) preferences and need for comprehensive care for relief from suffering. The primary coping strategies included family companionship, protective buffering and faith-based support. Participants lacked knowledge of palliative care. They expressed the importance of relief from suffering, viewing it as the health sector's responsibility and requesting more humane, personalised care and access to medicines and pain clinics., Conclusions: The multifaceted nature of SHS highlights the health system's responsibility to provide high-quality palliative care. Policies to enhance access to palliative care should integrate it into primary care, redesigning services towards patient and caregiver biopsychosocial and spiritual needs and ensuring access to medicines and competent health personnel., Competing Interests: Competing interests: During the 36 months prior to publication, AB was a recipient of the Fulbright U.S. Scholar Teaching and Research Award from the Bureau of Educational and Cultural Affairs, U.S. Department of State for work inclusive of palliative care outside the submitted work; AB reports consulting fees through a research grant from the Medical Research Council to the University of Edinburgh and from the University of Miami for work related to palliative care outside the submitted work.SVD reports consulting fees from the University of Miami for work related to palliative care outside the submitted work.FK had research grant funding from Medical Research Council to the University of Miami and Funsalud (Mexican Health Foundation) for work related to palliative care; a research grant from the US Cancer Pain Relief funding to the University of Miami for work related to palliative care; research grant funding to Tómatelo a Pecho, AC outside of the scope of current work from Merck Sharp & Dohme; research grant funding to the University of Miami outside of the scope of current work from Merck KGaA/EMD Serono; research grant funding to Tómatelo a Pecho, AC outside of the scope of current work from Avon Cosmetics, S. de R. L. de C. V. and personal fees from Merck KGaA/EMD Serono. In addition, FK has been a Member of the Board of Directors of the International Association for Hospice and Palliative Care since 2020 (not compensated). No other competing interests were declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To identify individual and initial prescription-related factors associated with an increased risk for opioid-related misuse, poisoning and dependence (MPD) in patients with non-cancer pain., Methods: Cohort study linking several databases covering 5 million inhabitants of the region of Valencia, Spain, including all adults initiating prescription opioids in the period 2012-2018. To ascertain the association between the characteristics of the initial prescription choice and the risk of opioid MPD, we used shared frailty Cox regression models. We additionally considered death as a competing risk in sensitivity analyses., Results: 958 019 patients initiated opioid prescription from 2012 to 2018, of which 0.13% experienced MPD. Most patients were prescribed tramadol as initial opioid (76.7%) followed by codeine (16.3%), long-acting opioids (6.7%), short-acting opioids (0.2%) and ultrafast opioids (0.1%). Initiation with ultrafast (HR 7.2; 95% CI 4.1 to 12.6), short-acting (HR 4.8; 95% CI 2.3 to 10.2) and long-acting opioids (HR 1.5; 95% CI 1.2 to 1.9) were associated with a higher risk of MPD when compared with tramadol. Initial prescriptions covering 4-7 days (HR 1.3; 95% CI 1.0 to 1.8), 8-14 days (HR 1.4; 95% CI 1.0 to 1.9), 15-30 days (HR 1.7; 95% CI 1.2 to 2.3) and more than one a month (HR 1.8; 95% CI 1.3 to 2.5) were associated with more MPD risk than initial prescriptions for 1-3 days. Treatments with >120 daily morphine milligram equivalents (MME) increased MPD risk (vs <50 MME, HR 1.6; 95% CI 1.1 to 2.2). Main individual factors associated with increased risk of MPD risk were male sex (HR 2.4; 95% CI 2.1 to 2.7), younger age (when compared with patients aged 18-44 years, patients aged 45-64 years, HR 0.4; 95% CI 0.4 to 0.5; patients aged 65-74 years, HR 0.4; 95% CI 0.3 to 0.5 and patients aged 75 years old and over, HR 0.7; 95% CI 0.6 to 0.8), lack of economic resources (2.1; 95% CI 1.8 to 2.5) and registered misuse of alcohol (2.9; 95% CI 2.4 to 3.5). Sensitivity analyses yielded overall comparable results., Conclusions: Our study identifies riskier patterns of opioid prescription initiation for non-cancer indications, as well as patient subgroups with higher risk of misuse, poisoning and dependence., Competing Interests: Competing interests: The authors are employed by FISABIO, a research body in Spain affiliated with the Health Department of the Valencia Government. FISABIO signed a Collaboration agreement (2018–2019) with Grünenthal Pharma, to conduct independent research on 'Patterns of use of opioids in the National Health System', unrelated to the present work., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Patient and public involvement (PPI) in trials aims to enhance research by improving its relevance and transparency. Planning for statistical analysis begins at the design stage of a trial within the protocol and is refined and detailed in a Statistical Analysis Plan (SAP). While PPI is common in design and protocol development it is less common within SAPs. This study aimed to reach consensus on the most important and relevant statistical analysis items within an SAP to involve patients and the public., Methods: We developed a UK-based, two-round Delphi survey through an iterative consultation with public partners, statisticians, and trialists. The consultation process started with 55 items from international guidance for statistical analysis plans. We aimed to recruit at least 20 participants per key stakeholder group for inclusion in the final analysis of the Delphi survey. Participants were asked to vote on each item using a Likert scale from 1 to 9, where a rating of 1 to 3 was labelled as having 'limited importance'; 4 to 6 as 'important but not critical' and 7 to 9 as 'critical' to involve patients and the public. Results from the second round determined consensus on critical items for PPI., Results: The consultation exercise led to the inclusion of 15 statistical items in the Delphi survey. We recruited 179 participants, of whom 72% (129: 36 statisticians, 29 patients or public partners, 25 clinical researchers or methodologists, 27 trial managers, and 12 PPI coordinators) completed both rounds. Participants were on average 48 years old, 60% were female, 84% were White, 64% were based in England and 84% had at least five years' experience in trials. Four items reached consensus regarding critical importance for patient and public involvement: presentation of results to trial participants; summary and presentation of harms; interpretation and presentation of findings in an academic setting; factors impacting how well a treatment works. No consensus was reached for the remaining 11 items. In general, the results were consistent across stakeholder groups., Discussion: We identified four critical items to involve patients and the public in statistical analysis plans. The remaining 11 items did not reach consensus and need to be considered in a case-by-case basis with most responders considering patient and public involvement important (but not critical). Our research provides a platform to enable focused future efforts to improve patient and public involvement in trials and enhance the relevance of statistical analyses to patients and the public., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Goulão et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: Chronic fatigue (CF) affects 25-30% of lymphoma survivors, but interventions designed to reduce fatigue are lacking. The main aim of this study was to test the feasibility of a multidimensional intervention study in lymphoma survivors with CF. Secondary aims were to describe individual changes in fatigue, quality of life (QoL) and physical performance from pre (T0) to post (T1) intervention., Methods: This feasibility study was as a one-armed intervention study performed in 2021. Hodgkin or aggressive non-Hodgkin lymphoma survivors received mailed study information and Chalder Fatigue Questionnaire and were asked to respond if they suffered from fatigue. The 12-week intervention included patient education, physical exercise, a cognitive behavioural therapy (CBT)-based group program and nutritional counselling. Feasibility data included patient recruitment, completion of assessments, adherence to the intervention and patient-reported experience measures. Participants responded to questionnaires and underwent physical tests at T0 and T1., Results: Seven lymphoma survivors with CF were included. Of all assessments, 91% and 83% were completed at T0 and T1, respectively. Adherence to the interventional components varied from 69% to 91%. At T1, all participants rated exercise as useful, of whom five rated the CBT-based program and five rated individual nutritional counselling as useful. Five participants reported improved fatigue, QoL and physical performance., Conclusion: Lymphoma survivors with CF participating in a multidimensional intervention designed to reduce the level of fatigue showed high assessment completion rate and intervention adherence rate. Most of the participants evaluated the program as useful and improved their level of fatigue, QoL and physical performance after the intervention., Trial Registration: ClinicalTrials.gov, identifier: NCT04931407. Registered 16. April 2021-Retrospectively registered. https://www., Clinicaltrials: gov/ct2/show/NCT04931407., (© 2023. The Author(s).)

Background: Several factors are associated with coronal and root caries in older persons. The purpose of this study was to determine the experience, prevalence, and risk indicators (socioeconomic, sociodemographic, and dental variables) of coronal and root caries in older persons residing in nursing homes in Mexico., Methods: A cross-sectional study was carried out in 227 dentate participants with natural teeth. Convenience sample, where all dentate residents were invited to participate. The dependent variables were coronal caries and root caries, which were determined through an oral clinical examination. The independent variables were sociodemographic factors, location, type of center, surfaces free of dental biofilm and calculus, surfaces with recession, retainers in contact with surfaces with recession, xerostomia, smoking, and the previous use of dental services. The binary logistic regression model was used in the analysis., Results: The mean age of the participants in this study was 77.7±8.8 years, and 69.2% were women. Moreover, 71.8% live in long-term care facilities, and 48.0% live in Mexico City. The prevalence of coronal and root caries was found to be 67.8% and 50.7%, respectively. Being male and living in Mexico City were risk indicators for coronal caries, and with a 1% increase in surfaces with no biofilm, the risk decreased by 2%. Being widowed, having government or no social security, denture retainers, and coronal caries were risk indicators for root caries, while the utilization of dental services indicated lower risk., Conclusion: Several variables that differ in nature were found to be risk indicators for coronal and root caries. Coronal caries increases the risk of root caries. Prevention should be aimed at identifying persons at higher risk, and dental care should be improved for persons living in long-term care institutions., Competing Interests: The authors report no conflicts of interest in this work., (© 2023 Tepox-Puga et al.)

Objective: To assess the clinical and cost effectiveness of conservative management compared with laparoscopic cholecystectomy for the prevention of symptoms and complications in adults with uncomplicated symptomatic gallstone disease., Design: Parallel group, pragmatic randomised, superiority trial., Setting: 20 secondary care centres in the UK., Participants: 434 adults (>18 years) with uncomplicated symptomatic gallstone disease referred to secondary care, assessed for eligibility between August 2016 and November 2019, and randomly assigned (1:1) to receive conservative management or laparoscopic cholecystectomy., Interventions: Conservative management or surgical removal of the gallbladder., Main Outcome Measures: The primary patient outcome was quality of life, measured by area under the curve, over 18 months using the short form 36 (SF-36) bodily pain domain, with higher scores (range 0-100) indicating better quality of life. Other outcomes included costs to the NHS, quality adjusted life years (QALYs), and incremental cost effectiveness ratio., Results: Of 2667 patients assessed for eligibility, 434 were randomised: 217 to the conservative management group and 217 to the laparoscopic cholecystectomy group. By 18 months, 54 (25%) participants in the conservative management arm and 146 (67%) in the cholecystectomy arm had received surgery. The mean SF-36 norm based bodily pain score was 49.4 (standard deviation 11.7) in the conservative management arm and 50.4 (11.6) in the cholecystectomy arm. The SF-36 bodily pain area under the curve up to 18 months did not differ (mean difference 0.0, 95% confidence interval -1.7 to 1.7; P=1.00). Conservative management was less costly (mean difference -£1033, (-$1334; -€1205), 95% credible interval -£1413 to -£632) and QALYs did not differ (mean difference -0.019, 95% credible interval -0.06 to 0.02)., Conclusions: In the short term (≤18 months), laparoscopic surgery is no more effective than conservative management for adults with uncomplicated symptomatic gallstone disease, and as such conservative management should be considered as an alternative to surgery. From an NHS perspective, conservative management may be cost effective for uncomplicated symptomatic gallstone disease. As costs, complications, and benefits will continue to be incurred in both groups beyond 18 months, future research should focus on longer term follow-up to establish effectiveness and lifetime cost effectiveness and to identify the cohort of patients who should be routinely offered surgery., Trial Registration: ISRCTN registry ISRCTN55215960., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme: KG reports being a member of the NIHR HTA Clinical Evaluation and Trials committee member since 2020; JB reports grants from NIHR Bristol Biomedical Research Centre and being a member of the NIHR Clinical Trials Unit Standing Advisory Committee 2015-19; SC is a co-investigator on unrelated grants from NIHR (HTA and Efficacy and Mechanism Evaluation: NIHR129819, 15/130/95, 15/130/20) for which her institution has received payment; BC reports a leadership or fiduciary role in the Association of Clinical Biochemistry and Laboratory medicine as president 2021-23, and Royal College of Pathologists as trustee and Scottish chair; CR reports grants from NIHR, during the conduct of the study, and member of the NIHR HTA general funding committee from 2017 to present. No other financial relationships with any organisations that might have an interest in the submitted work in the previous three years; there are no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal., Objective: To develop a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for factorial trials., Design: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT extension for factorial trials was developed by (1) generating a list of reporting recommendations for factorial trials using a scoping review of methodological articles identified using a MEDLINE search (from inception to May 2019) and supplemented with relevant articles from the personal collections of the authors; (2) a 3-round Delphi survey between January and June 2022 to identify additional items and assess the importance of each item, completed by 104 panelists from 14 countries; and (3) a hybrid consensus meeting attended by 15 panelists to finalize the selection and wording of items for the checklist., Findings: This CONSORT extension for factorial trials modifies 16 of the 37 items in the CONSORT 2010 checklist and adds 1 new item. The rationale for the importance of each item is provided. Key recommendations are (1) the reason for using a factorial design should be reported, including whether an interaction is hypothesized, (2) the treatment groups that form the main comparisons should be clearly identified, and (3) for each main comparison, the estimated interaction effect and its precision should be reported., Conclusions and Relevance: This extension of the CONSORT 2010 Statement provides guidance on the reporting of factorial randomized trials and should facilitate greater understanding of and transparency in their reporting.

Background: The World Health Organization Disability Assessment Schedule 2.0 12-item survey (WHODAS-12) is a questionnaire developed by the WHO to measure functioning across health conditions, cultures, and settings. WHODAS-12 consists of a subset of the 36 items of WHODAS-2.0 36-item questionnaire. Little is known about the minimal important difference (MID) of WHODAS-12 in persons with chronic low back pain (LBP), which would be useful to determine whether rehabilitation improves functioning to an extent that is meaningful for people experiencing the condition. Our objective was to estimate an anchor-based MID for WHODAS-12 questionnaire in persons with chronic LBP., Methods: We analyzed data from two cohort studies (identified in our previous systematic review) conducted in Europe that measured functioning using the WHODAS-36 in adults with chronic LBP. Eligible participants were adults with chronic LBP with scores on another measure as an anchor to indicate participants with small but important changes in functioning over time [Short-form-36 Physical Functioning (SF36-PF) or Oswestry Disability Index (ODI)] at baseline and follow-up (study 1: 3-months post-treatment; study 2: 1-month post-discharge from hospital). WHODAS-12 scores were constructed as sums of the 12 items (scored 0-4), with possible scores ranging from 0 to 48. We calculated the mean WHODAS-12 score in participants who achieved a small but meaningful improvement on SF36-PF or ODI at follow-up. A meaningful improvement was an MID of 4-16 on ODI or 5-16 on SF36-PF., Results: Of 70 eligible participants in study 1 (mean age = 54.1 years, SD = 14.7; 69% female), 18 achieved a small meaningful improvement based on SF-36 PF. Corresponding mean WHODAS-12 change score was - 3.22/48 (95% CI -4.79 to -1.64). Of 89 eligible participants in study 2 (mean age = 65.5 years, SD = 11.5; 61% female), 50 achieved a small meaningful improvement based on ODI. Corresponding mean WHODAS-12 change score was - 5.99/48 (95% CI - 7.20 to -4.79)., Conclusions: Using an anchor-based approach, the MID of WHODAS-12 is estimated at -3.22 (95% CI -4.79 to -1.64) or -5.99 (95% CI - 7.20 to -4.79) in adults with chronic LBP. These MID values inform the utility of WHODAS-12 in measuring functioning to determine whether rehabilitation or other health services achieve a minimal difference that is meaningful to patients with chronic LBP., (© 2023. The Author(s).)

Background: Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require "plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols" be included in trial protocols. It is unknown how often protocols report this retention information. The purpose of our scoping review is to establish if, and how, trial teams report plans for retention during the design stage of the trial., Materials and Methods: A scoping review with searches in key databases (PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014 to 2019 inclusive) to identify randomised controlled trial protocols. We produced descriptive statistics on the characteristics of the trial protocols and also on those adhering to SPIRIT item 18b. A narrative synthesis of the retention strategies was also conducted., Results: Eight-hundred and twenty-four protocols met our inclusion criteria. RCTs (n = 722) and pilot and feasibility trial protocols (n = 102) reported using the SPIRIT guidelines during protocol development 35% and 34.3% of the time respectively. Of these protocols, only 9.5% and 11.4% respectively reported all aspects of SPIRIT item 18b "plans to promote participant retention and to complete follow-up, including list of any outcome data for participants who discontinue or deviate from intervention protocols". Of the RCT protocols, 36.8% included proactive "plans to promote participant retention" regardless of whether they reported using SPIRIT guidelines or not. Most protocols planned "combined strategies" (48.1%). Of these, the joint most commonly reported were "reminders and data collection location and method" and "reminders and monetary incentives". The most popular individual retention strategy was "reminders" (14.7%) followed by "monetary incentives- conditional" (10.2%). Of the pilot and feasibility protocols, 40.2% included proactive "plans to promote participant retention" with the use of "combined strategies" being most frequent (46.3%). The use of "monetary incentives - conditional" (22%) was the most popular individual reported retention strategy., Conclusion: There is a lack of reporting of plans to promote participant retention in trial protocols. Proactive planning of retention strategies during the trial design stage is preferable to the reactive implementation of retention strategies. Prospective retention planning and clear communication in protocols may inform more suitable choice, costing and implementation of retention strategies and improve transparency in trial conduct., (© 2023. The Author(s).)

Studies have shown that national-level initiatives to equip medical students with relevant digital competencies carry many benefits. Yet, few countries have outlined such competencies for clinical practice in the core medical school curriculum. This paper identifies current training gaps at the national level in digital competencies needed by students in the formal curricula of all three medical schools in Singapore from the perspectives of clinical educators and institutional leaders. It bears implications for countries that intend to implement standardized learning objectives for training in these digital competencies. Findings were drawn from in-depth interviews with 19 clinical educators and leaders of local medical schools. Participants were recruited using purposive sampling. Data were interpreted using qualitative thematic analysis. Thirteen of the participants were clinical educators while 6 were deans or vice deans of education from one of the three medical schools in Singapore. While the schools have introduced some relevant courses, they are not standardized nationally. Moreover, the school's niche areas have not been leveraged upon for training in digital competencies. Participants across all schools acknowledged that more formal training is needed in digital health, data management, and applying the principles of digital technologies. Participants also noted that the healthcare needs of the population, patient safety, and safe procedures in the utilisation of digital healthcare technologies should be prioritized when determining the competencies needed by students. Additionally, participants highlighted the need for stronger collaboration among medical schools, and for a stronger link between current curriculum and clinical practice. The findings highlighted the need for better collaboration among medical schools in the sharing of educational resources and expertise. Furthermore, stronger collaborations with professional bodies and the healthcare system should be established to ensure that the goals and outcomes of medical education and the healthcare system are aligned.

This paper is the fourth of a series of narrative reviews to critically rethink underexplored concepts in oral health research. The series commenced with an initial commissioned framework of Inclusion Oral Health, which spawned further exploration into the social forces that undergird social exclusion and othering. The second review challenged unidimensional interpretations of the causes of inequality by bringing intersectionality theory to oral health. The third exposed how language, specifically labels, can perpetuate and (re)produce vulnerability by eclipsing the agency and power of vulnerabilised populations. In this fourth review, we revisit othering, depicted in the concept of stigma. We specifically define and conceptualize oral health-related stigma, bringing together prior work on stigma to advance the robustness and utility of this theory for oral health research., (© 2023 The Authors. Community Dentistry and Oral Epidemiology published by John Wiley & Sons Ltd.)

Background and Objective: First study to assess any compensatory increase in use of non-opioid illicit substances and alcohol in opioid dependent patients randomized to treatment with extended-release naltrexone (XR-NTX) or buprenorphine-naloxone (BP-NLX) and in longer term treatment with extended-release naltrexone., Method: A multicenter, outpatient, open-label randomized clinical trial where patients received intramuscular extended-release naltrexone hydrochloride, 380 mg/month, or daily sublingual buprenorphine-naloxone 8-24/2-6 mg for 12 weeks, and an option to continue with extended-release naltrexone for an additional 36 week follow-up. The study was conducted at five urban addiction clinics and detoxification units in Norway between November 2012, and July 2016., Results: Among the 143 patients, 106 men and 37 women, there were no significant differences between those randomized to XR-NTX or BP-NLX in the risk of first relapse to alcohol (HR 1.31; 0.68-2.53), amphetamines (HR 0.88; 0.43-1.80), benzodiazepines (HR 1.24; 0.74-2.09) or cannabis (HR 1.55; 0.83-2.89). Also in the 36-week (12-48 weeks) follow-up period we found no significant differences between patients continuing with XR-NTX compared to those switching to XR-NTX after the randomized period in risk of first relapse to any non-opioid substance. In both study periods, the mean time in the study were longer among those relapsing to non-opioid addictive substances than those who did not. There was no significant association between first relapse to illicit opioids and first relapse to non-opioid addictive substances., Conclusion: There was no increase in the risk of relapse to non-opioid addictive substances neither in short term nor longer-term treatment with extended-release naltrexone. Trial registrationclinicaltrials.gov Identifier: NCT01717963., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023. Published by Elsevier Inc.)

Purpose: Despite international policies to support the health and wellbeing of informal (family) caregivers, there is no consensus on how to evaluate the effectiveness of carer support. We aimed to develop and validate a new quality-of-life measure for carers (LTCQ-Carer) and to assess its potential for use within a clinical pathway., Methods: Psychometric properties of LTCQ-Carer were tested through cognitive interviews (qualitative phase) and a pilot survey (quantitative phase). Participants were family caregivers of people recently diagnosed with mild cognitive impairment (MCI) or dementia, recruited through one of 14 memory clinics in south-east England. They self-completed the new measure and comparative existing measures (EQ-5D, ASCOT-Carer). Ongoing feedback from memory clinic staff on potential use of LTCQ-Carer was collected., Results: Interview participants (n = 10) found all draft items of LTCQ-Carer relevant and prompted inclusion of a new item on 'time to yourself'. Responses from survey participants (n = 107) indicated acceptability (low missing data), high internal reliability (Cronbach's α = 0.95), and a general construct (single factor loadings 0.43-0.86 for all items). Observation of predicted associations with EQ-5D and ASCOT-Carer supported construct validity. Responsiveness requires further testing as evidence was inconclusive. Clinical staff feedback on potential use was positive., Conclusion: LTCQ-Carer is a valid new measure for assessing family caregivers' quality of life across broad health and social care domains, expanding the range of high-quality tools for evaluating carer support. When used concurrently with patient assessment, it could highlight carer needs and prompt appropriate family support at the earliest point in the clinical pathway., (© 2023. The Author(s).)

Aim: To establish patient factors associated with a successful colon capsule endoscopy (CCE) test., Method: This prospective cohort study used data collected from patients who underwent CCE as part of the ScotCap evaluation prior to April 2020. A CCE was defined as successful if the capsule visualized the whole colon and rectum (complete test) with sufficient bowel cleansing to permit assessment of the colonic mucosa (adequate bowel preparation). Factors from patients in symptomatic and surveillance groups were analysed for associations with a successful test, complete test, adequate bowel preparation and requirement for further procedure using univariate, multivariate logistic, least absolute shrinkage and selection operator regression., Results: Data from 263 symptomatic and 137 surveillance patients were analysed. There was an association between a symptomatic patient's age and a successful test (OR = 0.97, 95% CI: 0.95-0.99), adequate bowel preparation (OR = 0.97, 95% CI: 0.94-1.00) and further procedure requirement (OR = 1.04, 95% CI: 1.02-1.06). An association was found, for symptomatic patients, between a faecal immunochemical test result in the range 10-399 μg/g and a further procedure (OR = 2.32, 95% CI: 1.23-4.48). In patients undergoing surveillance for previous colorectal cancer (OR = 0.42, 95% CI: 0.18-0.97), had previous bowel resection surgery (OR = 0.43, 95% CI: 0.19-0.98) or took a beta blocker medication (OR = 0.32, 95% CI: 0.11-0.88), an association was found with further procedure requirement., Conclusions: Among symptomatic patients, younger age was associated with obtaining a successful CCE test. Clinicians could consider patient selection based on these results to improve the rate of successful testing in clinical practice., (© 2023 Association of Coloproctology of Great Britain and Ireland.)

Social differences in body mass index and health behaviors are a major public health challenge. The uneven distribution of unhealthy body mass index and of unhealthy behaviors such as smoking, physical inactivity, and harmful alcohol consumption has been shown to mediate social inequalities in chronic diseases. While differential exposures to these health variables have been investigated, the extent to which they vary over the lifetime in the same population and their relationship with level of education is not well understood. This study examines patterns of body mass index and multiple health behaviors (smoking, physical activity and alcohol consumption), and investigates their association with education level among adults living in Northern Norway. It presents findings from a longitudinal multiple correspondence analysis of the Tromsø Study. Longitudinal data from 8,906 adults aged 32-87 in 2007-2008, with repeated measurements in 2015-2016 were retrieved from the survey's sixth and seventh waves. The findings suggest that most in the study population remained in the same categories of body mass index and the three health behaviors at the follow-up, with a clear educational gradient in healthy patterns. That is, both healthy changes and maintained healthy categories were associated with the highest education levels. Estimating differential exposures to mediators of health inequalities could benefit policy priority setting for tackling inequalities in health., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Ibarra-Sanchez et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: The curative oesophageal cancer continuum-diagnosis, treatment and survivorship represents different phases with its own challenges for the involved parties. The process of treatment decisions and interactions between patients with oesophageal cancer (EC), relatives and health professionals is vital yet not well described. The purpose of the study was to explore patients' and relatives' experiences with the process of decision-making through the EC illness and treatment trajectory., Methods: Longitudinal explorative design was employed based on ethnographic fieldwork in the form of participant observations inspired by the American anthropologist James Spradley., Results: Sixteen patients and 18 relatives were recruited for participant observations. In total, 184 hours of participant observations were conducted. The study showed that decision-making was filled with tension and edginess. Four themes were identified: 1) The encounter with the medical authority, 2) The need to see the big picture in the treatment trajectory, 3) A predetermined treatment decision, and 4) Meeting numerous different health professionals., Conclusion: The EC trajectory and decision-making were filled with anxiety. Patients and relatives lacked an overview of the treatment pathway, leading to their role in decision-making often being governed by the medical authority. Timing information and continuity are vital factors in decision-making.

Aim: To establish, for the first time, the clinically important differences for the ICIQ-UI-SF and ICIQ-FLUTS questionnaires following surgical and conservative treatments for stress-predominant urinary incontinence in women., Methods: Data from the SIMS and OPAL randomised controlled trials were analysed using an anchor-based method. Clinically important difference (CID; score change indicating a successful outcome) and minimal important difference (MID; score change indicating the smallest noticeable difference) were estimated using the PGI-I scale as the anchor., Results: For ICIQ-UI-SF, following surgical management, CIDs were 5.0 (95%CI 4.3, 5.6) at 1 year and 4.9 points (95%CI 4.2, 5.5) at 3 years, while following conservative management, CIDs were 4.0 (95%CI 3.4, 4.5) at 1 year and 4.6 points (95%CI 4.0, 5.2) at 2 years. For ICIQ-FLUTS, the CID was 3.4 points (95%CI 2.9, 4.0) at 1 year for both surgical and conservative management. MIDs for ICIQ-UI-SF, after surgical treatment, were 4.7 (95% CI 3.2, 6.1) at 1 year and 1.6 points (95%CI -0.2, 3.0) at 3 years, and after conservative treatment they were 1.7 (95% CI 1.0, 2.5) at 1 year and 1.9 points (95%CI 1.1, 2.7) at 2 years. For ICIQ-FLUTS, MIDs were 1.8 (95% CI 0.6, 3.1) at 1 year and 3.2 points (95%CI 2.0, 4.4) at 2 years after surgical treatment, and 1.3 (95%CI 0.6, 1.9) at 1 year and 1.9 points (95%CI 1.1, 2.6) at 2 years after conservative treatment., Conclusion: Our study is the first to establish the CID for the ICIQ-UI-SF and ICIQ-FLUTS that women would associate with a successful outcome 3-years post-surgery and 2-years post-conservative treatment of stress-predominant urinary incontinence. The MID was lower following conservative compared to surgical treatment., (© 2023. Crown.)

Background/aims: Sharing trial results with participants is an ethical imperative but often does not happen. Show RESPECT (ISRCTN96189403) tested ways of sharing results with participants in an ovarian cancer trial (ISRCTN10356387). Sharing results via a printed summary improved patient satisfaction. Little is known about staff experience and the costs of communicating results with participants. We report the costs of communication approaches used in Show RESPECT and the views of site staff on these approaches., Methods: We allocated 43 hospitals (sites) to share results with trial participants through one of eight intervention combinations (2 × 2 × 2 factorial; enhanced versus basic webpage, printed summary versus no printed summary, email list invitation versus no invitation). Questionnaires elicited data from staff involved in sharing results. Open- and closed-ended questions covered resources used to share results and site staff perspectives on the approaches used. Semi-structured interviews were conducted. Interview and free-text data were analysed thematically. The mean additional site costs per participant from each intervention were estimated jointly as main effects by linear regression., Results: We received questionnaires from 68 staff from 41 sites and interviewed 11 site staff. Sites allocated to the printed summary had mean total site costs of sharing results £13.71/patient higher (95% confidence interval (CI): -3.19, 30.60; p = 0.108) than sites allocated no printed summary. Sites allocated to the enhanced webpage had mean total site costs £1.91/patient higher (95% CI: -14, 18.74; p = 0.819) than sites allocated to the basic webpage. Sites allocated to the email list had costs £2.87/patient lower (95% CI: -19.70, 13.95; p = 0.731) than sites allocated to no email list. Most of these costs were staff time for mailing information and handling patients' queries. Most site staff reported no concerns about how they had shared results (88%) and no challenges (76%). Most (83%) found it easy to answer queries from patients about the results and thought the way they were allocated to share results with participants would be an acceptable standard approach (76%), with 79% saying they would follow the same approach for future trials. There were no significant effects of the randomised interventions on these outcomes. Site staff emphasised the importance of preparing patients to receive the results, including giving opt-in/opt-out options, and the need to offer further support, particularly if the results could confuse or distress some patients., Conclusions: Adding a printed summary to a webpage (which significantly improved participant satisfaction) may increase costs to sites by ~£14/patient, which is modest in relation to the cost of trials. The Show RESPECT communication interventions were feasible to implement. This information could help future trials ensure they have sufficient resources to share results with participants., Competing Interests: Declaration of conflicting interestThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AS, JB, CS, AJC, NJ-H, CD-M, KG, TI and WJC have nothing to declare. MRS reports grants from Clovis; grants and non-financial support from Astellas, Janssen, Novartis, Pfizer and Sanofi; personal fees from Lilly Oncology and Janssen, outside the submitted work. BEB reports receiving consulting fees from Lilly outside the submitted work.

Importance: Trial protocols outline a trial's objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available., Objective: To develop a consensus-based extension to the SPIRIT 2013 Statement for factorial trials., Evidence Review: The SPIRIT extension for factorial trials was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. First, a list of reporting recommendations was generated using a scoping review of methodological articles identified using a MEDLINE search (inception to May 2019), which was supplemented with relevant articles from the personal collections of the authors. Second, a 3-round Delphi survey (January to June 2022, completed by 104 panelists from 14 countries) was conducted to assess the importance of items and identify additional recommendations. Third, a hybrid consensus meeting was held, attended by 15 panelists to finalize selection and wording of the checklist., Findings: This SPIRIT extension for factorial trials modified 9 of the 33 items in the SPIRIT 2013 checklist. Key reporting recommendations were that the rationale for using a factorial design should be provided, including whether an interaction is hypothesized; the treatment groups that will form the main comparisons should be identified; and statistical methods for each main comparison should be provided, including how interactions will be assessed., Conclusions and Relevance: In this consensus statement, 9 factorial-specific items were provided that should be addressed in all protocols of factorial trials to increase the trial's utility and transparency.

Objectives: Patients presenting with symptoms suggestive of acute coronary syndrome (ACS) contribute to a high workload and overcrowding in the Emergency Department (ED). Accelerated diagnostic protocols for non-ST-elevation myocardial infarction have proved challenging to implement. One obstacle is the turnaround time for analyzing high-sensitivity cardiac troponin (hs-cTn). In the WESTCOR-POC study (Clinical Trials number NCT05354804) we aim to evaluate safety and efficiency of a 0/1 h hs-cTn algorithm utilizing a hs-cTnI point of care (POC) instrument in comparison to central laboratory hs-cTnT measurements., Design: This is a prospective single-center randomized clinical trial aiming to include 1500 patients admitted to the ED with symptoms suggestive of ACS. Patients will receive standard investigations following the European Society of Cardiology 0/1h protocols for centralized hs-cTnT measurements or the intervention using a 0/1h POC hs-cTnI algorithm. Primary end-points are 1) Safety; death, myocardial infarction or acute revascularization within 30 days 2) Efficiency; length of stay in the ED, 3) Cost- effectiveness; total episode cost, 4) Patient satisfaction, 5) Patient symptom burden and 6) Patients quality of life. Secondary outcomes are 12-months death, myocardial infarction or acute revascularization, percentage discharged after 3 and 6 h, total length of hospital stay and all costs related to hospital contact within 12 months., Conclusion: Results from this study may facilitate implementation of POC hs-cTn testing assays and accelerated diagnostic protocols in EDs, and may serve as a valuable resource for guiding future investigations for the use of POC high sensitivity troponin assays in outpatient clinics and prehospital settings.

Introduction: COVID-19 is associated with an increased risk of venous thromboembolism (VTE), but there is great variation among reported incidence rates. Most previous studies have focused on hospitalized patients with COVID-19, and only a few reports are from population-based registries., Methods: We studied the 90-day incidence of VTE, associated risk factors and all-cause mortality in hospitalized and nonhospitalized patients with COVID-19 in a nationwide cohort. Data on hospitalizations and outpatient visits were extracted from two national registries with mandatory reporting linked by a unique national identification number carried by all Norwegian residents. We performed Cox proportional hazards regression to determine risk factors for VTE after infection with SARS-CoV-2., Results: Our study included 30,495 patients with positive SARS-CoV-2 polymerase chain reaction with a mean (SD) age of 41.9 (17.3) years, and 53% were males. Only 2081 (6.8%) were hospitalized. The 90-day incidence of VTE was 0.3% (95% CI: 0.21-0.33) overall and 2.9% (95% CI: 2.3-3.7) in hospitalized patients. Age (hazard ratio [HR] 1.28 per decade, 95% CI: 1.11-1.48, p < 0.05), history of previous VTE (HR 4.69, 95% CI: 2.34-9.40, p < 0.05), and hospitalization for COVID-19 (HR 23.83, 95% CI: 13.48-42.13, p < 0.05) were associated with risk of VTE., Conclusions: The 90-day incidence of VTE in hospitalized and nonhospitalized patients with COVID-19 was in the lower end compared with previous reports, with considerably higher rates in hospitalized than nonhospitalized patients. Risk factors for VTE were consistent with previously reported studies., (© 2023 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.)

Background: The aim of this trial-based economic evaluation was to assess the incremental costs and cost-effectiveness of the modified diagnostic strategy combining the YEARS rule and age-adjusted D-dimer threshold compared with the control (which used the age-adjusted D-dimer threshold only) for the diagnosis of pulmonary embolism (PE) in the Emergency Department (ED)., Methods: Economic evaluation from a healthcare system perspective alongside a non-inferiority, crossover, and cluster-randomized trial conducted in 16 EDs in France and two in Spain with three months of follow-up. The primary endpoint was the additional cost of a patient without failure of the diagnostic strategy, defined as venous thromboembolism (VTE) diagnosis at 3months after exclusion of PE during the initial ED visit. Mean differences in 3-month failure and costs were estimated using separate generalized linear-regression mixed models, adjusted for strategy type, period, and the interaction between strategy and period as fixed effects and the hospital as a random effect. The incremental cost-effectiveness ratio (ICER) was obtained by dividing the incremental costs by the incremental frequency of VTE., Results: Of the 1,414 included patients, 1,217 (86%) were analyzed in the per-protocol analysis (648 in the intervention group and 623 in the control group). At three months, there were no statistically significant differences in total costs (€-46; 95% CI: €-93 to €0.2), and the failure rate was non inferior in the intervention group (-0.64%, one-sided 97.5% CI: -∞ to 0.21%, non-inferiority margin 1.5%) between groups. The point estimate of the incremental cost-effectiveness ratio (ICER) indicating that each undetected VTE averted in the intervention group is associated with cost savings of €7,142 in comparison with the control group. There was a 93% probability that the intervention was dominant. Similar results were found in the as randomized population., Conclusions: Given the observed cost decrease of borderline significance, and according to the 95% confidence ellipses, the intervention strategy has a potential to lead to cost savings as a result of a reduction in the use of chest imaging and of the number of undetected VTE averted. Policy-makers should investigate how these monetary benefits can be distributed across stakeholders., Clinicaltrials: Trial registration number ClinicalTrials.gov Identifier: NCT04032769; July 25, 2019., (© 2023. The Author(s).)