Perspectives on systematic review protocol registration: a survey amongst stakeholders in the clinical research publication process.

BACKGROUND: As systematic reviews (SRs) inform healthcare decisions, it is key that they address relevant questions and use rigorous methodology. Registration of SR protocols helps researchers identify relevant topics for future reviews and aims to prevent bias and duplication of effort. However, most SRs protocols are currently not registered, despite its significance. To guide future recommendations to enhance preregistration of SRs, it is important to gain a comprehensive understanding of the perspectives within the research community. Therefore, this study aims to examine the experiences with and factors of influence (barriers and facilitators) on prospective SR registration amongst researchers, peer reviewers and journal editors. METHODS: Two different surveys were distributed to two groups: researchers and journal editors both identified from an existing sample of SRs. Researchers who indicated to have peer reviewed a SR were surveyed on their perspectives as peer reviewers as well. Survey design and analysis were informed by the Consolidated Framework for Implementation Research (CFIR). Shared and unique subthemes from the perspectives of researchers, peer reviewers and journal editors were identified and linked to the SR registration process (Innovation), to team, organisation (Inner setting) and (inter)national research community (Outer setting), and to characteristics of researchers, peer reviewers or journal editors (Individuals). RESULTS: The survey's response rates were 65/727 (9%) for researchers, of which 37 were peer reviewers, and 22/308 (7%) for journal editors. Most respondents (n = 76, 94%) were familiar with SR protocol registration and 81% of researchers had registered minimally one SR protocol. Shared SR registration process subthemes were the importance and advantages of SR protocol registration, as well as barriers such as a high administrative burden. Shared subthemes regarding the inner and outer setting centred on journal processes, external standards and time. Shared individual factors were knowledge, skills and awareness. CONCLUSIONS: The majority of the respondents were familiar with SR protocol registration and had a positive attitude towards it. This study identified suboptimal registration process, administrative burden and lack of mandatory SR protocol registration as barriers. By overcoming these barriers, SR protocol registration could contribute more effectively to the goals of open science. SYSTEMATIC REVIEW REGISTRATION: osf.io/gmv6z.

Treatment-seeking behaviour among 15-49-year-olds with self-reported heart disease, cancer, chronic respiratory disease, and diabetes: a national cross-sectional study in India.

BACKGROUND: Eighty per cent of India´s non-communicable disease (NCD) mortality is due to four conditions: heart disease, cancer, chronic respiratory disease, and diabetes, which are primarily cause-amenable through treatment. Based on Andersen's behavioural model of health services use, the current study aimed to identify the predisposing, enabling, and need factors associated with treatment-seeking status among people self-reporting the four main NCDs in India. METHODS: Cross-sectional study using secondary data. Usual residents aged 15-49 who self-reported cancer (n = 1 056), chronic respiratory disease (n = 10 534), diabetes (n = 13 501), and/or heart disease (n = 5 861) during the fifth National Family and Health Survey (NFHS-5), 2019-21, were included. Treatment-seeking status was modelled separately for each disease using survey-adjusted multivariable logistic regression. RESULTS: 3.9% of India´s 15-49-year-old population self-reported ≥ 1 of the four main NCDs (0.1% cancer, 1.4% chronic respiratory disease, 2% diabetes, 0.8% heart disease). The percentage that had sought treatment for their condition(s) was 82%, 68%, 76%, and 74%, respectively. Greater age and having ≥ 1 of the NCDs were associated with greater odds of seeking disease-specific treatment. People in the middle or lower wealth quintiles had lower odds of seeking care than the wealthiest 20% for all conditions. Women with diabetes or chronic respiratory disease had greater odds of seeking disease-specific treatment than men. Muslims, the unmarried, and those with health insurance had greater odds of seeking cancer treatment than Hindus, the married, and the uninsured. CONCLUSION: Predisposing, enabling, and need factors are associated with treatment-seeking status among people reporting the four major NCDs in India, suggesting that multiple processes inform the decision to seek disease-specific care among aware cases. Successfully encouraging and enabling as many people as possible who knowingly live with major NCDs to seek treatment is likely contingent on a multi-pronged approach to healthcare policy-making. The need to improve treatment uptake through accessible healthcare is further underscored by the fact that one-fifth (cancer) to one-third (chronic respiratory disease) of 15-49-year-olds reporting a major NCD have never sought treatment despite being aware of their condition.

Does mechanical loading restore ligament biomechanics after injury? A systematic review of studies using animal models.

BACKGROUND: Mechanical loading is purported to restore ligament biomechanics post-injury. But this is difficult to corroborate in clinical research when key ligament tissue properties (e.g. strength, stiffness), cannot be accurately measured. We reviewed experimental animal models, to evaluate if post-injury loading restores tissue biomechanics more favourably than immobilisation or unloading. Our second objective was to explore if outcomes are moderated by loading parameters (e.g. nature, magnitude, duration, frequency of loading). METHODS: Electronic and supplemental searches were performed in April 2021 and updated in May 2023. We included controlled trials using injured animal ligament models, where at least one group was subjected to a mechanical loading intervention postinjury. There were no restrictions on the dose, time of initiation, intensity, or nature of the load. Animals with concomitant fractures or tendon injuries were excluded. Prespecified primary and secondary outcomes were force/stress at ligament failure, stiffness, laxity/deformation. The Systematic Review Center for Laboratory animal Experimentation tool was used to assess the risk of bias. RESULTS: There were seven eligible studies; all had a high risk of bias. All studies used surgically induced injury to the medial collateral ligament of the rat or rabbit knee. Three studies recorded large effects in favour of ad libitum loading postinjury (vs. unloading), for force at failure and stiffness at 12-week follow up. However, loaded ligaments had greater laxity at initial recruitment (vs. unloaded) at 6 and 12 weeks postinjury. There were trends from two studies that adding structured exercise intervention (short bouts of daily swimming) to ad libitum activity further enhances ligament behaviour under high loads (force at failure, stiffness). Only one study compared different loading parameters (e.g. type, frequency); reporting that an increase in loading duration (from 5 to 15 min/day) had minimal effect on biomechanical outcomes. CONCLUSION: There is preliminary evidence that post-injury loading results in stronger, stiffer ligament tissue, but has a negative effect on low load extensibility. Findings are preliminary due to high risk of bias in animal models, and the optimal loading dose for healing ligaments remains unclear.

Diagnostic Accuracy of Clinical Tests Assessing Ligamentous Injury of the Talocrural and Subtalar Joints: A Systematic Review With Meta-Analysis.

CONTEXT: Ankle sprains are the most common acute musculoskeletal injury. Clinical tests represent the first opportunity to assess the sprain's severity, but no systematic review has compared these tests to contemporary reference standards. OBJECTIVE: To determine the diagnostic accuracy of clinical tests assessing the talocrural and subtalar joint ligaments after ankle sprain. DATA SOURCES: CINAHL, EMBASE, MEDLINE, hand-searching, and PubMed-related article searches (inception to November 18, 2020). STUDY SELECTION: Eligible diagnostic studies compared clinical examination (palpation, joint laxity) against imaging or surgery. Studies at a high risk of bias or with high concerns regarding applicability on Quality Assessment of Diagnostic Accuracy Studies-2 were excluded from the meta-analysis. STUDY DESIGN: Systematic review and meta-analysis. LEVEL OF EVIDENCE: Level 3a. DATA EXTRACTION: True-positive, false-negative, false-positive, and true-negative findings were extracted to calculate sensitivity, specificity, and likelihood ratios. If ordinal data were reported, these were extracted to calculate Cohen's kappa. RESULTS: A total of 14 studies met the inclusion criteria (6302 observations; 9 clinical tests). No test had both sensitivity and specificity exceeding 90%. Palpation of the anterior talofibular ligament is highly sensitive (sensitivity 95%-100%; specificity 0%-32%; min-max; n = 6) but less so for the calcaneofibular ligament (sensitivity 49%-100%; specificity 26%-79%; min-max; n = 6). Pooled data from 6 studies (885 observations) found a low sensitivity (54%; 95% CI 35%-71%) but high specificity (87%; 95% CI 63%-96%) for the anterior drawer test. CONCLUSION: The anterior talofibular ligament is best assessed using a cluster of palpation (rule out), and anterior drawer testing (rule in). The talar tilt test can rule in injury to the calcaneofibular ligament, but a sensitive clinical test for the ligament is lacking. It is unclear if ligamentous injury grading can be done beyond the binary (injured vs uninjured), and clinical tests of the subtalar joint ligaments are not well researched. The generalizability of our findings is limited by insufficient reporting on blinding and poor study quality. REGISTRATION: Prospero ID: CRD42020187848. DATA AVAILABILITY: Data are available in a public, open access repository on publication, including our RevMan file and the CSV file used for meta-analysis: http://doi.org/10.5281/zenodo.4917138.