UNASSIGNED: To describe and analyze the methodological characteristics and quality of cross-sectional studies that have validated an ICF-CS.
UNASSIGNED: A systematic review was conducted to identify empirical studies published in English that validated any ICF-CS using a cross-sectional design. Databases searched included Web of Science, Scopus, CINAHL, PubMed, Embase, and PsycINFO. The search was conducted in November 2022 with an update in October 2023. Two independent reviewers coded studies that met the inclusion criteria and assessed their methodological quality and risk of bias using the AXIS tool. Synthesis was performed by calculating frequencies and percentages.
UNASSIGNED: 87 articles validating 24 ICF-CSs were analyzed. Most articles showed strengths in consistency between study objectives and the outcome variables measured. However, a large majority did not report sample size calculation (up to 94.2% in Delphi studies), and few validation studies were conducted in the WHO regions of Africa and the Eastern Mediterranean.
UNASSIGNED: The quality of cross-sectional studies validating ICF-CSs was satisfactory, although several articles did not describe aspects such as sample size calculation. Validity evidence for ICF-CS studies could be improved by conducting more multicenter studies, replicating ICF-CS validation studies in different WHO regions, and through synthesis of existing research.
Cross-sectional validation studies of ICF-CSs have satisfactory quality, supporting the use of the CSs in clinical rehabilitation settings similar to those evaluated here.Additional validation studies are required for ICF-CSs that have not yet been validated or for which validity evidence is limited.The methodological findings of this review constitute a roadmap that could guide the development and improve the quality of future ICF-CS validation studies.Knowing which ICF-CSs are validated through cross-sectional designs is useful for planning and designing interventions and instrument development.

OBJECTIVE: In pursuit of health equity, the World Health Organization has recently called for more extensive monitoring of inequalities in eye health. Population-based eye health surveys can provide this information, but whether underserved groups are considered in the design, implementation, and reporting of surveys is unknown. We conducted a systematic methodological review of surveys published since 2000 to examine how many population-based eye health surveys have considered underserved groups in their design, implementation, or reporting.
METHODS: We identified all population-based cross-sectional surveys reporting the prevalence of objectively measured vision impairment or blindness. Using the PROGRESS + framework to identify underserved groups, we assessed whether each study considered underserved groups within 15 items across the rationale, sampling or recruitment methods, or the reporting of participation and prevalence rates.
RESULTS: 388 eye health surveys were included in this review. Few studies prospectively considered underserved groups during study planning or implementation, for example within their sample size calculations (n = 5, ∼1%) or recruitment strategies (n = 70, 18%). The most common way that studies considered underserved groups was in the reporting of prevalence estimates (n = 374, 96%). We observed a modest increase in the number of distinct PROGRESS + factors considered by a publication over the study period. Gender/sex was considered within at least one item by 95% (n = 367) of studies. Forty-three percent (n = 166) of included studies were conducted primarily on underserved population groups, particularly for subnational studies of people living in rural areas, and we identified examples of robust population-based studies in socially excluded groups.
CONCLUSIONS: More effort is needed to improve the design, implementation, and reporting of surveys to monitor inequality and promote equity in eye health. Ideally, national-level monitoring of vision impairment and service coverage would be supplemented with smaller-scale studies to understand the disparities experienced by the most underserved groups.

Habits represent repeated patterns of behavior over time that exert a significant influence on individual health. While specific tools exist to measure individual habits, the number of instruments capable of simultaneously exploring multiple dimensions of health is limited. This research had two main objectives: 1) to examine the literature to find existing tools for evaluating health habits, especially in the Spanish population; 2) through a methodological review, to develop and validate a tool capable of measuring multiple dimensions of health habits. The Nutritional and Social Health Habits Scale (NutSo-HH) was conceived, tested, and refined through pilot testing with cognitive interviews and expert content validation. Construct validity was explored through confirmatory factor analysis and known-group validity, while criterion validity was verified in comparison with the ``Healthy Nutrition Index for the Spanish Population.\'\' Reliability was assessed using omega coefficients. Confirmatory factor analysis yielded satisfactory fit indices. The final model included two second-order factors (nutritional habits and health habits) and two first-order factors (Mediterranean diet and alcohol consumption). Omega coefficients ranged from 0.521 to 0.815. The NutSo-HH Scale emerges as a valid and reliable tool to assess nutritional and social habits among Spanish young adults. This novel instrument fills a gap in the field, allowing exploration of various health determinants through a single scale and providing support for decision-making in the realm of public health nutrition.

OBJECTIVE: Given the key role that pilot and feasibility (PAF) trials play in addressing the challenges of surgical trials, adequate reporting completeness is essential. Our aim was to assess completeness of reporting and evaluate if the items of the Consolidated Standards of Reporting Trials (CONSORT) extension for PAF trials have been reported in surgical PAF trials.
METHODS: This is a metaresearch study reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary outcome was overall adherence to the CONSORT statement extension to randomized PAF trials checklist. A Poisson regression was performed to explore the association between research factors and reporting completeness.
METHODS: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from January 1-December 31, 2011 and 2021.
RESULTS: After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. The mean CONSORT reporting score across all included studies was 21.5 (standard deviation 6.3). After excluding items that were not applicable to all studies, a mean of 20.1 (standard deviation 6.1) of 34 items (0.59) were reported. Studies published in 2021 (vs 2011) did not have a greater number of CONSORT items reported (incidence rate ratio [IRR] 1.01, 95% confidence interval [CI] 0.89-1.15). Studies registered in a clinical trial registry (IRR 1.29, 95% CI 1.12-1.48) and randomizing more than 50 patients (IRR 1.16, 95% CI 1.04-1.30) were associated with more CONSORT items reported.
CONCLUSIONS: The reporting completeness of surgical PAF trials is poor and has not improved after the publication of the CONSORT extension.

OBJECTIVE: An emerging body of randomized controlled trials (RCTs) on COVID-19 vaccines has served as the evidence base for public health decision-making. While it is recommended that RCTs report results by health equity stratifiers to reduce bias in health care and gaps in research, it is unknown whether this was done in COVID-19 vaccine trials. To critically examine the use of health equity stratifiers in COVID-19 vaccine trials.
METHODS: We conducted a methodological review of published COVID-19 vaccine trials available in the COVID-19 living Network Meta-Analysis systematic review database through February 8, 2023. Based on the PROGRESS-Plus framework, we examined the following health equity stratifiers: place of residence, race/ethnicity, occupation, gender/sex, religion, education, socio-economic status, social capital, age, disability, features of relationships, and temporary situations. We assessed each study in duplicate according to three criteria for comprehensive health-equity reporting: 1) describing participants, 2) reporting equity-relevant results, and 3) discussing equity-relevant implications of trial findings.
RESULTS: We reviewed 144 trial manuscripts. The most frequently used PROGRESS-Plus stratifiers to describe participants were age (100%), place of residence (100%), gender/sex (99%), and race/ethnicity (64%). Age was most often used to disaggregate or adjust results (67%), followed by gender or sex (35%). Discussions of equity-relevant implications often indicated limited generalizability of results concerning age (40% of studies). Half (47%) of the studies considered at least one health equity stratifier for all three criteria. No trials included stratifiers related to religion, socioeconomic status, sexual orientation, or features of relationships.
CONCLUSIONS: COVID-19 vaccine trials provided a limited description of health equity stratifiers as defined by PROGRESS-Plus and infrequently disaggregated results or discussed the study implications as they related to health equity. Considering the health disparities exacerbated during the pandemic, increased uptake of PROGRESS-Plus in RCTs would support a more nuanced understanding of health disparities and better inform actions to improve health equity.

This methodological review includes literature (1987-2022) concerning the role and influence of musical practices-including music therapy and participatory music interventions-on well-being in carceral settings such as jails, prisons, and immigration detention centers. We provide a thorough description of key methodological procedures used in 55 studies: (1) Key Elements of Research Questions; (2) Types of Musical Practices; (3) Musical Genres; (4) Methodologies and Designs; (5) Locations; (6) Theoretical Frameworks; and (7) Samples. Our review indicates that there is difficulty in conducting research in prisons due to limitations imposed on researchers, a paucity of randomized-control trials, and limited generalizability of results due to the heterogeneity of methodological approaches. We suggest that the literature base would benefit from increased attention to issues related to sampling procedures, research questions related to race and gender identity, as well as the delineation between the types of musical practices utilized by music interventions.

BACKGROUND: Quantifying spatial access to care-the interplay of accessibility and availability-is vital for healthcare planning and understanding implications of services (mal-)distribution. A plethora of methods aims to measure potential spatial access to healthcare services. The current study conducts a systematic review to identify and assess gravity model-type methods for spatial healthcare access measurement and to summarize the use of these measures in empirical research.
METHODS: A two-step approach was used to identify (1) methodological studies that presented a novel gravity model for measuring spatial access to healthcare and (2) empirical studies that applied one of these methods in a healthcare context. The review was conducted according to the PRISMA guidelines. EMBASE, CINAHL, Web of Science, and Scopus were searched in the first step. Forward citation search was used in the second step.
RESULTS: We identified 43 studies presenting a methodological development and 346 empirical application cases of those methods in 309 studies. Two major conceptual developments emerged: The Two-Step Floating Catchment Area (2SFCA) method and the Kernel Density (KD) method. Virtually all other methodological developments evolved from the 2SFCA method, forming the 2SFCA method family. Novel methodologies within the 2SFCA family introduced developments regarding distance decay within the catchment area, variable catchment area sizes, outcome unit, provider competition, local and global distance decay, subgroup-specific access, multiple transportation modes, and time-dependent access. Methodological developments aimed to either approximate reality, fit a specific context, or correct methodology. Empirical studies almost exclusively applied methods from the 2SFCA family while other gravity model types were applied rarely. Distance decay within catchment areas was frequently implemented in application studies, however, the initial 2SFCA method remains common in empirical research. Most empirical studies used the spatial access measure for descriptive purposes. Increasingly, gravity model measures also served as potential explanatory factor for health outcomes.
CONCLUSIONS: Gravity models for measuring potential spatial healthcare access are almost exclusively dominated by the family of 2SFCA methods-both for methodological developments and applications in empirical research. While methodological developments incorporate increasing methodological complexity, research practice largely applies gravity models with straightforward intuition and moderate data and computational requirements.

The stepped-wedge cluster randomized trial (SW-CRT), in which clusters are randomized to a time at which they will transition to the intervention condition - rather than a trial arm - is a relatively new design. SW-CRTs have additional design and analytical considerations compared to conventional parallel arm trials. To inform future methodological development, including guidance for trialists and the selection of parameters for statistical simulation studies, we conducted a review of recently published SW-CRTs. Specific objectives were to describe (1) the types of designs used in practice, (2) adherence to key requirements for statistical analysis, and (3) practices around covariate adjustment. We also examined changes in adherence over time and by journal impact factor.
We used electronic searches to identify primary reports of SW-CRTs published 2016-2022. Two reviewers extracted information from each trial report and its protocol, if available, and resolved disagreements through discussion.
We identified 160 eligible trials, randomizing a median (Q1-Q3) of 11 (8-18) clusters to 5 (4-7) sequences. The majority (122, 76%) were cross-sectional (almost all with continuous recruitment), 23 (14%) were closed cohorts and 15 (9%) open cohorts. Many trials had complex design features such as multiple or multivariate primary outcomes (50, 31%) or time-dependent repeated measures (27, 22%). The most common type of primary outcome was binary (51%); continuous outcomes were less common (26%). The most frequently used method of analysis was a generalized linear mixed model (112, 70%); generalized estimating equations were used less frequently (12, 8%). Among 142 trials with fewer than 40 clusters, only 9 (6%) reported using methods appropriate for a small number of clusters. Statistical analyses clearly adjusted for time effects in 119 (74%), for within-cluster correlations in 132 (83%), and for distinct between-period correlations in 13 (8%). Covariates were included in the primary analysis of the primary outcome in 82 (51%) and were most often individual-level covariates; however, clear and complete pre-specification of covariates was uncommon. Adherence to some key methodological requirements (adjusting for time effects, accounting for within-period correlation) was higher among trials published in higher versus lower impact factor journals. Substantial improvements over time were not observed although a slight improvement was observed in the proportion accounting for a distinct between-period correlation.
Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.

Cancer is a major public health concern associated with an increased risk of psychosocial distress and suicide. The reasons for this increased risk are still being characterized. The purpose of this study is to highlight existing observational studies on cancer-related suicides in the United States and identify gaps for future research. This work helps inform clinical and policy decision-making on suicide prevention interventions and ongoing research on the detection and quantification of suicide risk among cancer patients. We identified 73 peer-reviewed studies (2010-2022) that examined the intersection of cancer and suicide using searches of PubMed and Embase. Overall, the reviewed studies showed that cancer patients have an elevated risk of suicide when compared to the general population. In general, the risk was higher among White, male, and older cancer patients, as well as among patients living in rural areas and with lower socioeconomic status. Future studies should further investigate the psychosocial aspects of receiving a diagnosis of cancer on patients\' mental health as well as the impact of new treatments and their availability on suicide risk and disparities among cancer patients to better inform policies.

UNASSIGNED: Traditionally, within dose-finding clinical trials, treatment toxicity and tolerability are assessed by clinicians. Research has shown that clinician reporting may have inadequate inter-rater reliability, poor correlation with patient reported outcomes, and under capture the true toxicity burden. The introduction of patient-reported outcomes (PROs), where the patient can assess their own symptomatic adverse events or quality of life, has potential to complement current practice to aid dose optimisation. There are no international recommendations offering guidance for the inclusion of PROs in dose-finding trial design and analysis. Our review aimed to identify and describe current statistical methods and data visualisation techniques employed to analyse and visualise PRO data in published early phase dose-finding oncology trials (DFOTs).
UNASSIGNED: DFOTs published from June 2016-December 2022, which presented PRO analysis methods, were included in this methodological review. We extracted 35 eligible papers indexed in PubMed. Study characteristics extracted included: PRO objectives, PRO measures, statistical analysis and visualisation techniques, and whether the PRO was involved in interim and final dose selection decisions.
UNASSIGNED: Most papers (30, 85.7%) did not include clear PRO objectives. 20 (57.1%) papers used inferential statistical techniques to analyse PROs, including survival analysis and mixed-effect models. One trial used PROs to classify a clinicians\' assessed dose-limiting toxicities (DLTs). Three (8.6%) trials used PROs to confirm the tolerability of the recommended dose. 25 trial reports visually presented PRO data within a figure or table within their publication, of which 12 papers presented PRO score longitudinally.
UNASSIGNED: This review highlighted that the statistical methods and reporting of PRO analysis in DFOTs are often poorly described and inconsistent. Many trials had PRO objectives which were not clearly described, making it challenging to evaluate the appropriateness of the statistical techniques used. Drawing conclusions based on DFOTs which are not powered for PROs may be misleading. With no guidance and standardisation of analysis methods for PROs in early phase DFOTs, it is challenging to compare study findings across trials. Therefore, there is a crucial need to establish international guidance to enhance statistical methods and graphical presentation for PRO analysis in the dose-finding setting.
UNASSIGNED: EA has been supported to undertake this work as part of a PhD studentship from the Institute of Cancer Research within the MRC/NIHR Trials Methodology Research Partnership. AM is supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at the Royal Marsden NHS Foundation Trust, the Institute of Cancer Research and Imperial College.