OBJECTIVE:To explore stakeholder experiences with implementing the living guideline (LG) development framework in oncology, and to identify barriers, facilitators and solutions to support its uptake and sustainability. DESIGN:An exploratory sequential mixed methods design was used, beginning with qualitative semi-structured interviews with guideline development stakeholders, analysed thematically; and followed by a cross-sectional survey to quantitatively rate the importance of factors identified in phase one. SETTING:National and international oncology guideline development programmes using the LG development framework. PARTICIPANTS:Stakeholders involved in LG development, including expert panel co-chairs, panel members, patient representatives, methodologists and administrative staff. RESULTS:Nine stakeholders participated in qualitative interviews, and 45 completed the survey. Most participants were male (5/9:56% qualitative; 26/45:58% quantitative) and based in the US (7/9:78% and 29/45:64%, respectively). Overall, the results from both the qualitative and quantitative strand revealed seven themes (34 subthemes) as barriers and six themes (21 subthemes) as facilitators. Additionally, 9 themes were proposed as solutions. The most frequently reported barriers included evidence timeliness, interpretation and publication delays. Prominent facilitators included effective management, resource optimisation and panel engagement. Participants strongly endorsed investment in artificial intelligence enhanced tools to improve the speed and efficiency of evidence acquisition and review. CONCLUSION:While the LG framework provides strong methodological guidance, its practical application presents notable challenges, particularly in resource demands and implementation logistics. Successful adoption requires adequate infrastructure, expertise and oversight. These findings highlight critical considerations for developers aiming to implement sustainable LG models in oncology and beyond.
ABSTRACT Background Artificial intelligence (AI) and automation offer opportunities to enhance the efficiency, timeliness, and sustainability of living guidelines (LGs). However, how AI and automation have been integrated into existing LG development frameworks remains unclear. This scoping review represents the first step in a broader programme of work aimed at developing a framework which aims to guide responsible and coordinated AI adoption across all phases of LG development. Objective To identify existing frameworks, methods, and approaches that integrate AI or automation into any stage of LG development. Methods We conducted a structured search of PubMed, Embase, Web of Science, Scopus, Cochrane Database for Systematic Review and Cochrane Central Register of Controlled Trials from inception to March 12, 2026. We included peer‐reviewed articles describing frameworks, models, or methods that applied AI or automation in the development of LGs. We extracted data into a standardised form, capturing study characteristics, AI methods, targeted guideline processes, and key findings and synthesised findings using a thematic narrative approach. Results Of 1090 records identified, three studies met the inclusion criteria. The included studies described AI or automation applied to select components of the LG process, to support continuous evidence surveillance, to semi‐automate study screening, and incremental updating of living systematic reviews. None addressed multiple stages of LG development in an integrated manner. Conclusions Current evidence demonstrates fragmented and narrowly focused AI or automation applications within LG development processes. Our findings highlight opportunities for future work to develop and evaluate more comprehensive frameworks that span multiple stages of the LG lifecycle.
Background Dance is an artistic and social form of exercise and has been shown to be effective across the lifespan. Intergenerational dance programmes can have beneficial effects in reducing discrimination and fostering communities. Previous intergenerational dance programmes included small sample sizes or were not designed to target physical outcomes. There is a need for well-designed community-based intergenerational dance programmes to target the needs of older adults (OAs) and adolescents addressing physical activity, ageism and loneliness.Aims and objectives The aim of this study was to co-design and refine the content of an intergenerational dance programme with OAs and adolescents using the ‘six steps in quality intervention development framework’ (6SQuID). The objectives were to complete steps 1–4 of the 6SQuID framework and run a short pilot study with OAs.Design A proof-of-concept pilot study.Setting The programme took place in a local community centre.Participants 12 participants were recruited (n=5 adolescents; n=7 OAs). Adolescents were aged between 14 and 16 years. OAs were aged 60 years and older.Interventions The intervention was led by a physiotherapist and dance teacher and comprised of intergenerational practice and social dance.Primary and secondary outcome measures Outcome measures focused on physical activity, well-being, ageism and mobility. Accelerometers were used to establish programme intensity. Focus groups were conducted to explore the opinions of participants. Qualitative data were analysed using Thematic Analysis.Results Six OAs and four adolescents completed the programme. The average age of OAs was 72.8±6.69 years and the adolescents were aged 14–16 years. The intensity of the classes was driven by participants, with some achieving vigorous intensity, and most achieving light-moderate intensity. This accounted for an average of 28.36 (±11.02) min of the class. The outcome measures were found to be meaningful for participants; however, more challenging balance measures were suggested by both cohorts. The social dance was enjoyable, especially when the music was tailored to participants’ preferences. Meeting with other age groups was valued, and it was suggested that more time should be given to icebreakers and socialising.Conclusions Intergenerational dance may be a promising way of improving well-being, intergenerational connections and achieving moderate-intensity activity. The process of designing an evidence-based intervention in this paper can be used to guide researchers and practitioners in designing an intergenerational arts-based programme.
BACKGROUND AND OBJECTIVES:Methodological studies critically evaluate how health research is designed, conducted, analyzed, and reported. Despite their growing importance, currently, there is no reporting tailored to this type of research, which hampers the visibility, reproducibility, and overall utility of the findings of methodological studies. METHODS:We administered a survey to researchers with expertise in designing and performing methodological studies to gather their opinions on appropriate terminology, how they should be categorized, and key reporting elements. Quantitative data were analyzed descriptively, with a content validity ratio applied to determine appropriateness. Qualitative survey responses were analyzed using inductive content analysis. RESULT:Of 499 invited, a total of 119 participants completed the survey (response rate 23%). None of the 13 proposed nomenclatures met the threshold for appropriateness. Of the four proposed study categories, two (study aim and study design) were retained based on expert ratings. Among 23 proposed reporting items, 15 were endorsed for further evaluation. Qualitative responses were condensed and categorized, identifying the importance of flexibility in terminology and concerns about categorization. CONCLUSION:There is substantial disagreement among experts regarding key aspects of methodological studies, particularly related to terminology. While some agreement was observed around study categories and reporting elements, diverse and sometimes conflicting perspectives underscore the complexity of standardizing methodological studies. These findings reinforce the need for a collaborative consensus process to develop reporting guidance that is both practical and adaptable to the nuances of this field.
OBJECTIVES:Observational studies suggest that acid suppression may worsen outcomes among patients infected with SARS-CoV-2. The objectives of this embedded substudy of a randomised controlled trial evaluating pantoprazole in mechanically ventilated patients were to (1) describe the clinical characteristics of critically ill patients with SARS-CoV-2, (2) compare clinical outcomes with a propensity-matched non-infected cohort and (3) assess whether pantoprazole's treatment effects differed by SARS-CoV-2 infection status. DESIGN:A pre-planned substudy of the re-evaluating the inhibition of stress erosions (REVISE) trial, including a propensity-matched analysis of infected and non-infected patients comparing the effect of pantoprazole between patients with and without SARS-CoV-2. SETTING:68 intensive care units (ICUs) in eight countries. PARTICIPANTS:From July 2019 to October 2023, 4821 eligible participants were enrolled in REVISE whether or not they had SARS-CoV-2 infection. PRIMARY AND SECONDARY OUTCOME MEASURES:Participants enrolled in REVISE with SARS-CoV-2 infection had additional data collection, including biomarkers, venous thromboembolism, SARS-CoV-2 therapies and tracheostomy timing. The primary outcomes were clinically important upper gastrointestinal bleeding and 90-day mortality. Secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, patient-important upper GI bleeding, renal replacement therapy, ICU and hospital mortality and duration of mechanical ventilation, ICU and hospital stay. RESULTS:Of the eligible trial cohort, 11.9% (540/4550) had SARS-CoV-2; 532 patients had additional SARS-CoV-2-specific data collection. Of these 532 patients, 87.8% received COVID-19-directed treatments-(dexamethasone 75.2%), 11.7% developed pulmonary embolism and 9.2% developed deep-vein thrombosis. After propensity matching, SARS-CoV-2 infection was not associated with clinically important upper gastrointestinal bleeding (adjusted HR 0.78, 95% CI 0.40 to 1.50) but was associated with significantly higher ICU, hospital and 90-day mortality, as well as longer duration of ventilation and ICU and hospital length of stay. The effect of pantoprazole on clinically important upper GI bleeding and 90-day mortality was consistent regardless of SARS-CoV-2 status. CONCLUSIONS:SARS-CoV-2 infection was associated with higher mortality and longer duration of mechanical ventilation, ICU and hospital stays, without an increased risk of clinically important upper gastrointestinal bleeding. Pantoprazole reduced clinically important upper gastrointestinal bleeding without adversely affecting other outcomes. TRIAL REGISTRATION NUMBER:REVISE trial (NCT03374800), SARS-CoV-2 cohort study (NCT05715567).
Anti-infective agents are widely used during pregnancy to prevent, treat, and mitigate the transmission of infections, and their utilisation has significantly increased over the past decade. However, concerns persist regarding their potential embryotoxicity, compounded by inconsistencies in safety data that complicate medication decision-making. This protocol details an umbrella review that aims to provide a comprehensive and methodologically sound synthesis of evidence from systematic reviews (SRs) on the adverse effects of prenatal anti-infective exposure on offspring. The review will incorporate a standardised, three-stage data extraction strategy and an R-based algorithm to efficiently identify and manage overlapping evidence. We will conduct a comprehensive search across six databases (PubMed, Embase, Scopus, Web of Science, Cochrane Library, and Epistemonikos) from inception to June 22, 2024. The search will cover three key concepts—pregnant women, anti-infective agents, and systematic reviews—without restrictions on controls or outcomes. We will include SRs, with or without meta-analyses, that evaluate the adverse effects of prenatal anti-infective exposure and report either neonatal outcomes (e.g. birth defects) or long-term offspring outcomes (e.g. neurodevelopmental disorders). To address overlapping evidence, a structured three-stage data extraction process, supported by an R-based algorithm, will be implemented, sequentially handling PICO definition extraction, overlapping evidence management, and quantitative data extraction. At least two independent reviewers will screen studies, extract data, and assess methodological quality and evidence strength using AMSTAR-2 and GRADE, respectively. Evidence synthesis will be conducted narratively, drawing on meta-analytic associations from direct comparative analyses and organising findings by anti-infective agents, indications, outcomes, effect estimates, certainty of evidence, and methodological quality. Anti-infectives with safety concerns will be summarised in tables and evidence maps. By adopting a standardised process that incorporates an automated algorithm for managing overlapping evidence, the planned umbrella review will provide a comprehensive synthesis of existing evidence on the adverse effects of anti-infective use during pregnancy. The findings are expected to inform clinical practice, guide policy decisions, and support infection management in pregnant patients. Furthermore, the review will identify key knowledge gaps, help prioritise future research, and ultimately contribute to improving maternal and offspring health outcomes. PROSPERO CRD42024577013
QuestionWhat are the late adverse consequences among survivors of pediatric acute kidney injury (AKI)?FindingsIn this systematic review and meta-analysis of 39 studies involving 16 151 children, AKI was associated with an increased risk of late adverse outcomes. Children with a history of AKI had higher odds of developing chronic kidney disease and higher late mortality, and risk was further elevated in those with more severe AKI.MeaningThese findings underscore the importance of structured, long-term follow-up and kidney health surveillance for children after AKI, particularly for those with moderate or severe injury. This systematic review and meta-analysis estimates the pooled incidence and relative risk of chronic kidney disease, mortality, hypertension, and proteinuria following acute kidney injury in hospitalized children. ImportanceAcute kidney injury (AKI) is a common complication among hospitalized children and may have lasting kidney and cardiovascular consequences. However, the long-term risks after pediatric AKI have not been comprehensively quantified.ObjectiveTo estimate the pooled incidence and relative risk with odds ratio of chronic kidney disease (CKD), mortality, hypertension, and proteinuria following AKI in hospitalized children.Data SourcesPubMed, Embase, and Web of Science were searched from January 2007 through November 2025 without language restrictions.Study SelectionStudies were included if they reported at least 1 long-term outcome (CKD, mortality, hypertension, or proteinuria) following AKI in hospitalized children. Studies limited to children with obstructive lesions, primary vascular disorders (eg, hemolytic uremic syndrome) or solid organ transplant were excluded.Data Extraction and SynthesisTwo reviewers independently extracted data and assessed risk of bias. Random-effects meta-analyses were performed to estimate pooled cumulative incidences and odds ratios (ORs) with 95% CIs.Main Outcomes and MeasuresCumulative incidence and odds of CKD, mortality, hypertension, and proteinuria following pediatric AKI.ResultsOf 17 068 screened records, 39 studies comprising 16 151 participants were included. The pooled cumulative incidences following AKI were 17% (95% CI, 12-22) for CKD, 6% (95% CI, 3-8) for mortality, 20% (95% CI, 12-29) for proteinuria, and 16% (95% CI, 11-23) for hypertension. In 23 studies with non-AKI comparators and follow-up ranging from 3 months to 18 years, AKI was associated with increased odds of CKD (OR, 1.74; 95% CI, 1.02-2.95) and mortality (OR, 1.92; 95% CI, 1.35-2.75) but not proteinuria (OR, 1.18; 95% CI, 0.62-2.25) or hypertension (OR, 1.29; 95% CI, 0.72-2.31). Greater AKI severity was associated with a higher odds of CKD (stages 2-3: OR, 2.84; 95% CI, 1.49-4.15; stage 1: OR, 1.72; 95% CI, 1.11-2.67).Conclusions and RelevanceThe findings in this systematic review and meta-analysis demonstrate that, similar to adults, children experienced increased risk of late adverse outcomes following AKI, particularly CKD and mortality, supporting the need for structured post-AKI follow up.
This study aims to assess the robustness of randomized control trials (RCTs) in the dental field by analyzing the fragility index (FI). The FI is a statistical measure defined as the smallest number of event changes needed to convert statistical significance (P< 0.05), of a binary outcome, to a not significant result. Previous studies have found that the results of many RCTs in medical disciplines are very fragile. However, there is limited literature examining the robustness of trials in dentistry. The primary objective of this study is to evaluate the fragility of RCTs in top dental journals using the FI. The secondary objective is to explore factors associated with fragility. We will identify RCTs from five high-impact dental journals namely, Periodontology 2000, International Journal of Oral Science, Journal of Clinical Periodontology, Journal of Dental Research, and Journal of Dentistry published between January 2019 and December 2024 reporting at least one primary binary outcome. We will estimate the FI and factors associated with FI will be assessed using regression analysis. Screening and data extraction began in August 2025 and are expected to conclude by December 2025. Data analysis will be conducted in January 2026, and we anticipate submitting the results for publication by March–April 2026. Dental practitioners rely on RCTs to guide patient care and treatment planning. Assessing the FI of trials allows us to determine the robustness of their results. By evaluating fragility, dental practitioners and policymakers can make more informed decisions on evidence based care and identify areas for further research.
Background:Youth with brain-based disabilities (BBD) need tailored support when preparing for adult healthcare. We originally designed a full randomized controlled trial (RCT) to test whether the MyREADY Transition™ BBD App improved transition readiness among youth aged 15-17 years with autism spectrum disorder, cerebral palsy, epilepsy, fetal alcohol spectrum disorder, or spina bifida. Due to slow recruitment, the full RCT was halted and pivoted to a stand-alone pilot and feasibility trial. Methods:This mixed method, patient-oriented pilot RCT (2019-2022, Canada) evaluated process, resource, management, and scientific feasibility, along with engagement with the App. Scientific feasibility focused on self-management outcomes (TRAQ and Transition-Q) among 43 youth (mean age 15.9 ± 0.8; 19 intervention, 24 control). Interviews and surveys provided additional perspectives on feasibility and user experience. Results:Recruitment achieved only 43 of the planned 264 participants, and App engagement was modest. Almost all intervention participants logged into the App at least once, but on average completed less than one third of the curriculum. Qualitative findings suggested the App's content was relevant and useful. Participants, caregivers, and healthcare providers emphasized the need for tailored, collaborative approaches to transition preparation. Conclusion:Challenges included slow recruitment and limited sustained use of an e health intervention among youth with BBD. Despite the pivot, the trial generated pragmatic insights for future transition research. Youth and parent recommendations underscored the importance of customizable content and strategies that enhance motivation and engagement. Additional pilot work is needed to refine and optimize digital transition supports.
This paper offers a first-person reflective account of one mentorship relationship, between an emerging health sciences scholar and a senior biostatistician, facilitated by South Africa’s Future Professors Programme. Drawing on five lessons from the mentorship – goal-setting, publication planning, the meaning of excellence, research integrity and the ethic of care – we examine how emerging scholars are socialised into the norms of a metric-driven academy, and how a care-oriented, ubuntu-inspired mentor can open space for a more substantive understanding of scholarly work. The account is situated within debates on neoliberal and neocolonial academic culture and on mentorship in South Africa and the Global South. We do not evaluate the Future Professors Programme as a whole, but reflect on a single case within one phase of the programme. We argue that the tensions described are features of the contemporary academy more broadly, and ask what it means to become a good scholar, not merely a productive one. Significance: Transformation of the South African professoriate is being pursued through the same metrics that historically excluded the scholars it now seeks to develop. Drawing on one mentorship within the Future Professors Programme, this paper shows how this contradiction is transmitted in practice through goal-setting tools, publication plans and promotion criteria absorbed without being chosen. It argues that genuine transformation requires more than demographic change in the professoriate: it requires changing what scholarship is taken to be for. The paper offers implications for mentors, programme designers and the metrics used to assess transformation.
INTRODUCTION:Patients are increasingly recognized as key interest holders in health care decision‑making. Integrating patient perspective is crucial to patient‑centered, evidence‑based nutrition guideline recommendations. OBJECTIVES:Our aim was to examine individual willingness to decrease consumption of foods high in saturated fatty acids (SFAs) after being informed about the estimated absolute risk reduction (ARR) of myocardial infarction (MI), together with the certainty of the supporting evidence based on a Cochrane systematic review. PATIENTS AND METHODS:Respondents from 7 countries were presented with a conversation aid with the ARR of MI, together with the certainty of evidence, and asked about their willingness to reduce their intake of SFA‑rich foods. Using a multivariable logistic regression model, we explored 12 variables to identify factors underlying respondent willingness to introduce dietary fat changes. RESULTS:We analyzed 3663 respondents from Brazil, Canada, China, Croatia, Poland, Spain, and the United States. Overall, 50.2% were willing to reduce their SFA intake. Women (odds ratio [OR], 1.51; 95% CI, 1.29-1.77), nonomnivores (OR, 1.73; 95% CI, 1.37-2.19), and respondents from Spain, China, and Brazil (OR, 2.45; 95% CI, 1.83-3.27; OR, 4.36; 95% CI, 3.49-5.45; and OR, 1.31; 95% CI, 1.08-1.58, respectively) showed greater willingness, whereas those from Croatia or holding a university degree showed lower willingness (OR, 0.7; 95% CI, 0.51-0.95; OR, 0.73; 95% CI, 0.61-0.87, respectively). CONCLUSIONS:The significant variation in people willingness (depending, eg, on sex, education levels, or dietary pattern) to reduce their intake of SFA‑rich foods underscores potential importance of incorporating patient preference when developing dietary guideline recommendations, and of promoting individualized evidence‑based care using absolute effects and certainty of evidence.
Pilot and feasibility trials help identify methodological and logistical challenges. However, biased reporting, known as “spin,” may distort overall study findings and mislead readers, presenting content through a subjective lens. Accurate assessments of feasibility are critical in orthopedic research, where the continued popularity of procedures such as hip and knee arthroplasties emphasizes a need for rapid advancement through research and development. The prevalence of spin practices among pilot and feasibility trials in hip and knee arthroplasties remains unclear. To evaluate the prevalence of spin reporting practices in pilot and feasibility trials focused on hip and knee arthroplasty. The secondary objective is to identify factors associated with the level of spin featured in the analyzed manuscripts. A search of PubMed identified 147 trials published between 2017 and 2023, selected using stratified random sampling. Studies were screened for the presence of three spin criteria defined in previous literature, and summarized descriptively. Spin appeared in 88.4
Frailty is a complex trait that significantly increases the risk for negative health consequences, including hospitalization and disability. However, the evidence regarding the genetic basis of frailty phenotype (FP) is very limited. We conducted a genome-wide association study (GWAS) on FP using the data from the Canadian Longitudinal Study on Aging (CLSA). We classified the participants as non-frail, pre-frail, and frail, and performed a GWAS utilizing the ordinal logistic regression adjusted for sex, number of chronic conditions, and 10 principal components. Several post-GWAS analyses, including cis-eQTL analyses, were conducted to investigate the potential functional significance. In total, 23,105 participants and more than 8 million imputed SNPs were included in the analysis. The average age was 63 years, and 50.35% of the participants were female. Most participants were non-frail (11,297; 48.89%) or pre-frail (10,261; 44.41%), whereas only 1547 (6.70%) were frail. One novel genomic variant (rs147311617) at the 12p22 locus was found significant at the level of genome-wide significance (p = 4.98×10 -8). This variant was identified near the PLXNC1 gene. The eQTL analysis identified the role of the SOCS2 gene. Our study demonstrated the role of genes, PLXCN1 and SOCS2, that contribute to frailty through neurological and immunological pathways.
Introduction Frequentist methods of statistical inference in randomized controlled trials (RCTs) may inadequately reflect clinical importance of results. We assessed whether three complementary approaches validly assess clinical importance and their impact on original conclusions. Methods In a sample of published superiority RCTs of health interventions, second-generation p-values, Bayes factors, and fragility indices were calculated for primary outcome results. Clinical importance was classified using effect size and confidence intervals relative to the reported minimum important difference. Agreement with clinical importance was measured by Cohen's Kappa estimates, positive predictive values (PPV) and negative predictive values (NPV). Results In the sample of 269 trials, second-generation p-values, Bayes factors and reverse fragility indices increased with decreasing clinical importance, while fragility indices decreased with decreasing clinical importance.Second-generation p-values showed strong alignment with clinical importance derived from a common minimum important difference. Among statistically significant studies, Bayes factor and fragility index showed poor agreement but high (>96%) PPV and low (<25%) NPV, while in not statistically significant studies, Bayes factor failed to identify clinically important trials but identified all non-clinically important trials. Reverse fragility index showed moderate agreement and yielded a PPV of 94.1% and a NPV of 46.5%.Original trial conclusions changed in 31.6% of trials using second-generation p-values, in 20.9% using Bayes factors, and in 57% of trials using fragility indices. Discussion Analysis plans and results interpretations should include quantitative assessments of clinical importance using second-generation p-values or Bayes factors, with robustness assessments using fragility indices.
Background GERAS DANcing for Cognition and Exercise (DANCE) was developed with rehabilitation and geriatric medicine expertise for older adults (age 60 +) looking to improve brain health or mobility. This trial aimed to assess the feasibility, acceptability, and safety of delivering virtual GERAS DANCE to older adults in a home-based setting. A single-center, prospective, parallel-group randomized feasibility trial was conducted to assess the feasibility of virtual GERAS DANCE. Fifty older adults were randomized to the virtual GERAS DANCE intervention group or a control group receiving usual care. The progressive dance curriculum was live-streamed with videoconference by a certified GERAS DANCE instructor in 1-h sessions held twice weekly for 6 weeks. Participants used their personal tablets, desktop computers, and laptops. Feasibility was evaluated based on predefined criteria, including process measures (e.g., recruitment and retention rates), outcome measures, resource utilization, and the acceptability of the intervention to participants. One hundred ninety three of 206 individuals met the eligibility criteria, indicating that the inclusion criteria were well-defined and suitable for the target population. The enrollment-to-screening ratio was 25:103, with recruitment completed in 8 weeks. Fifty older adults were randomized, and 46 completed baseline assessments (mean age = 75.02(5.89) years, range 63–92, 92
PURPOSE:To determine the feasibility and effectiveness of two forms of social support (peer and peer plus virtual professional support) on quality of life, feelings of support, and exercise levels in older adult survivors of cancer. METHODS:We conducted a pilot randomized controlled trial. Participants were randomized to the AgeMatchPLUS (peer support plus weekly qualified exercise professional support) or AgeMatch (peer support only) group. The primary outcome was feasibility (measured by recruitment, retention, adherence rates). Secondary outcomes included quality of life, social support, exercise volume, and physical activity enjoyment. Outcomes were measured at baseline (T1), post-intervention (10-weeks post baseline (T2)), post-tapering (14-weeks post baseline (T3)), and at 6-months follow-up (T4). Data was analyzed using descriptive statistics and a multiple linear regression was performed for all secondary outcomes to determine estimates of effect between groups. RESULTS:Virtual peer and professional exercise-related social support are feasible for older adults survivors of cancer. Those matched with a peer in addition to virtual professional support demonstrated improved exercise-related social support and resistance training volume post-intervention. No other significant differences were found between groups, with both groups significantly increasing their exercise levels across the study. CONCLUSION:We demonstrated the feasibility and benefit of peer matching, both independently and alongside professional support, for older survivors of cancer. Future research efforts should examine the effectiveness of this intervention on a larger scale and compare outcomes to a no intervention group. REGISTRY:This trial was registered on clinicaltrials.gov (NCT05549479, August 23, 2022).
Abstract Background As the global demand for hip and knee arthroplasty procedures grow, advancements in orthopedic research are vital for progress. Pilot and feasibility trials play a critical role in optimising research efficiency, highlighting methodological gaps, and maximising study insights. However, the completeness of reporting in hip and knee arthroplasty pilot and feasibility trials remains unclear. Objectives The primary objective was to evaluate reporting completeness, assessed using the CONSORT checklist extension to pilot and feasibility trials. Secondary objectives included evaluating the reporting of key feasibility items and exploring factors associated with reporting completeness. Setting and methods This methodological survey analysed pilot and feasibility trials in hip and knee arthroplasty. A PubMed search identified relevant manuscripts published between January 1, 2017, and December 31, 2023. A minimum acceptable sample size of 147 (of 278 eligible) was identified, based on a calculation involving an estimated reporting completeness of 25% of the CONSORT checklist, a 95% confidence interval, and a 5% margin of error. Descriptive statistics were reported, and a multivariable linear regression with robust (HC1) standard errors was completed. Results Of 278 eligible publications identified from PubMed, a random sample of 147 studies was included. Reporting completeness was low, with studies accounting for a mean of 54.98% (16.95) of applicable CONSORT extension items. Notably, pilot-specific objectives and future study implications were often underreported. Similarly, manuscripts missed approximately 71.35% (10/14) of key feasibility elements. Studies that referenced reporting guidelines in the manuscript text were associated with better reporting, while those that failed to disclose their funding sources and lacked more key feasibility items demonstrated weaker reporting completeness. Conclusion Hip and knee arthroplasty pilot and feasibility trials exhibit suboptimal reporting completeness with several missing feasibility elements. Improved adherence to CONSORT guidelines and enhanced transparency are needed.
In this study, we developed ML algorithms to predict fragility fractures, considering the occurrence of fractures at different skeletal sites, using the data from the Canadian Multicentre Osteoporosis Study (CaMos) with participants aged 50 years or older. We considered 73 baseline features, and the outcome was the first incidence of fracture at any of the following sites: hip, spine, pelvis, ribs, shoulder, and forearm. The ML algorithms were evaluated in terms of the ROC_AUC. SHapley Additive exPlanations (SHAP) analysis was performed to identify the important features and to investigate the interaction among these features. In total, 7753 subjects were included in the study. Approximately 72% were female, and the average age was 67 years. We found that the XGBoost algorithm had a slightly better ROC_AUC (0.70; 95% CI 0.67, 0.73). From the SHAP analysis, we found that BMD was the most important feature and the total hip BMD interacted the most with femoral neck BMD. This study demonstrated that XGBoost was a marginally superior ML algorithm for predicting fragility fractures. In addition, we identified important features that contribute to the prediction of fragility fractures. Intervention focusing on these features will help to prevent the incidence of these fractures.
Survivors of adolescent and young adult (AYA, age 15-39y) cancer are at risk for late-onset cancer therapy-related cardiac dysfunction (CTRCD) years after therapy completion which can progress to heart failure. It is unclear if any existing CTRCD risk prediction model is applicable to survivors of AYA cancer. Our objective was to identify and evaluate risk prediction models for late-onset CTRCD and examine applicability to survivors of AYA cancer. We searched multiple databases to identify CTRCD risk prediction models developed and/or validated in cancer survivors of any age, ≥ 1 year from diagnosis. We included full-text English studies using real-life patient data and routine clinical variables to predict late-onset CTRCD. We used the Prediction model Risk of Bias Assessment Tool to evaluate models for bias and applicability. We described studies, models, included risk factors, and participants overall and by age group. We screened 12,740 records and identified 22 studies which developed and/or validated 64 models for the prediction of late-onset CTRCD (54.7
Randomised controlled trials that use cohorts or health-and-care systems data, often known as routinely collected data-such as electronic health records, registries, or administrative claims-are becoming increasingly common. These trials have the potential to streamline recruitment, intervention delivery, follow-up (within trial and long term), and to lower costs. The lack of clear information governance pathways, heterogeneous data quality, delays in data recording and acquisition, and regulatory or ethical complexities undermine reproducibility and bias assessment when routinely collected data are used in trials. We introduce the SPIRIT-ROUTINE extension to the SPIRIT 2025 guideline: a checklist and explanation designed to improve the reporting of trial protocols that rely on cohorts or routinely collected data sources. Investigators, funders, ethics committees, journal editors, and peer reviewers can use the SPIRIT-ROUTINE extension to enhance completeness, transparency, and usability of such protocols to support better research, healthcare decisions, and patient outcomes.