To evaluate the effects of relaxation interventions on physical and psychological distress in informal cancer caregivers and identify effective intervention components.

A systematic review was conducted. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL Complete, Nursing & Allied Health Premium, Scopus, WHO International Clinical Trial Registry Platform, and PsycINFO were searched from January 1, 2010, to March 31, 2024. Risk of bias was conducted using the Mixed Methods Appraisal Tool.

We identified a diverse range of relaxation interventions including aerobic exercise, back massage, music therapy, art therapy, mindfulness meditation, and progressive muscle relaxation, demonstrating reduced caregiver burden, anxiety, and stress levels while improving sleep quality and overall quality of life. However, studies were limited by short follow-up periods and methodological diversity.

Relaxation interventions show promise in alleviating distress among cancer caregivers. Future studies should focus on optimizing intervention components and extending follow-up durations.

We aimed to examine a) the policies of national and international clinical trial registries regarding observational studies; b) the time trends of observational study registration; and c) the published arguments for and against observational study registration.

Scoping review of registry practices and published arguments. We searched the websites and databases of all 19 members of the World Health Organization's Registry Network to identify policies relating to observational studies and the number of observational studies registered annually from the beginning of the registries to 2022. Regarding documents with arguments, we searched Medline, Embase, Google Scholar, and top medical and epidemiological journals from 2009 to 2023. We classified arguments as "main" based on the number (n ≥ 3) of documents they occurred in.

Of 19 registries, 15 allowed observational study registration, of which seven (35%) had an explicit policy regarding what to register and two (11%) about when to register. The annual number of observational study registrations increased over time in all registries; for example, ClinicalTrials.gov increased from 313 in 1999 to 9775 in 2022. Fifty documents provided arguments concerning observational study registration: 31 argued for, 18 against, and one was neutral. Since 2012, 19 out of 25 documents argued for. We classified nine arguments as main: five for and four against. The two most prevalent arguments for were the prevention of selective reporting of outcomes (n = 16) and publication bias (n = 12), and against were that it will hinder exploration of new ideas (n = 17) and it will waste resources (n = 6).

Few registries have policies regarding observational studies; an increasing number of observational studies were registered; there was a lively debate on the merits of registration of observational studies, which, since 2012, seems to converge toward proregistration.

The importance of publicly registering clinical trials and reporting their results in registries is widely recognised. While substantial progress has been made with registering trials before enrolment, the availability of results in registries remains uncommon despite expanding legislative and funder requirements-leading to an incomplete evidence base and avoidable waste of resources, particularly for unpublished trials. This paper discusses the rationale for reporting summary results in trial registries, reviews the current landscape of registry policies, and presents new WHO guidance for reporting results in registries. The 2025 WHO guidance was developed after consultation with relevant parties, including researchers, patients, sponsors, funders, regulators, journal editors, registry administrators, and the public. The guidance defines eight minimum items that are essential for understanding and interpreting the summary results for all trials. Implementation of the WHO guidance by trial registries, broad adherence by investigators and sponsors, and endorsement by funders, regulators, legislators, research ethics committees, patient organisations, and journals can help enhance the contribution of trials to scientific knowledge, patient care, and health policy.

Interventional studies are intended to provide robust evidence. Yet poorly designed or conducted studies may bias research results and skew resulting evidence. While there have been advances in the assessment of risk of bias, it is unclear how to intervene against risks of bias during study design and conduct.

To identify interventions to reduce or predict risk of bias in interventional studies during their design and conduct.

For this scoping review, we searched three electronic bibliographic databases (MEDLINE, Embase, and Cochrane Library) and nine grey literature sources and Google from in September 2024. This was supplemented by a natural language processing fuzzy matching search of the top 2000 relevant publications in the electronic bibliographic databases. Publications were included if they described the implementation and effectiveness of an intervention during study design or conduct aimed at reducing risk of bias in interventional studies. The characteristics and effect of the interventions were recorded.

We identified, and reviewed the title and abstracts of, a total of 41,793 publications, reports, documents and grey literature, with 24,677 from electronic bibliographic databases and 17,140 from grey literature sources. There were 67 publications from bibliographic databases and 24 items from grey literature that were considered potentially eligible for inclusion, and the full-text of these were reviewed. Only three studies met the inclusion criteria. The first intervention was offering education and training to researchers during study design. This training included the implementation of a more rigorous participant screening process and systematic participant tracking program that reduced loss to follow-up and missing data, particularly for long-term follow-up trials. The second intervention was introducing an independent clinical events committee during study conduct. This was intended to mitigate bias due to conflicts of interest affecting the analysis and interpretation of results. The third intervention was to provide participants with financial incentives in randomized controlled trials, so that participants could more actively accomplish the requirements of the trials.

Despite the major impact of risk of bias on study outcomes, there are few empirical interventions to address this during study design or conduct.

To identify changes in immunological, microbiological, and histological biomarkers that may indicate resistance during the induction phase and resilience during the resolution phase of experimental peri-implant mucositis (PiM).

The search was performed in MEDLINE, EMBASE, Web of Science, SCOPUS, Cochrane Library, and LILACS databases. Prospective interventional studies assessing biomarkers during experimental PiM were included. The risk of bias was assessed using the Risk Of Bias In Non-Randomized Studies of Interventions (ROBINS-I) tool. Meta-analyses were conducted using random-effects models. The GRADE approach was used to determine the certainty of evidence.

Eleven out of 6008 studies were included. Clinical parameters (mPI and mGI) effectively characterized the experimental PiM model. Due to methodological variability and conflicting results, a definitive interpretation of microbiological and histological biomarkers was not possible. The meta-analysis revealed that IL-1β and the volume of peri-implant crevicular fluid (PICF) indicated non-resistance during the induction phase. In contrast, TNF-α, IL-6, IL-8, IL-17, MMP-8, and IFN-γ remained stable. Regarding the resolution phase, IL-1β returned to baseline levels (SMD: 1.13; 95% CI: -0.81, 3.06), and the volume of PICF (MD: 0.08; 95% CI: 0.03, 0.13) remained significantly elevated compared to day 0. However, TNF-α, IL-6, IL-8, IL-17, MMP-8, and IFN-γ did not significantly differ from baseline levels.

Moderate to very low evidence suggested that the biomarkers IL-1β and the volume of PICF indicated a lack of resistance while suggesting resilience and non-resilience, respectively. The biomarkers TNF-α, IL-6, IL-8, IL-17, MMP-8, and IFN-γ demonstrated resistance and resilience.

We assess if there are indications that results of registry-based studies comparing the effectiveness of interventions might be selectively missing depending on the statistical significance (p < 0.05).

Eligibility criteria Sample of cohort type studies that used data from a patient registry, compared two study arms for assessing a medical intervention, and reported an effect for a binary outcome. Information sources We searched PubMed to identify registries in seven different medical specialties in 2022/23. Subsequently, we included all studies that satisfied the eligibility criteria for each of the identified registries and collected p-values from these studies. Synthesis of results We plotted the cumulative distribution of p-values and a histogram of absolute z-scores for visual inspection of selectively missing results because of p-hacking, selective reporting, or publication bias. In addition, we tested for publication bias by applying a caliper test.

Included studies Sample of 150 registry-based cohort type studies. Synthesis of results The cumulative distribution of p-values displays an abrupt, heavy increase just below the significance threshold of 0.05 while the distribution above the threshold shows a slow, gradual increase. The p-value of the caliper test with a 10% caliper was 0.011 (k = 2, N = 13).

We found that the results of registry-based studies might be selectively missing. Results from registry-based studies comparing medical interventions should be interpreted very cautiously, as positive findings could be a result from p-hacking, publication bias, or selective reporting. Prospective registration of such studies is necessary and should be made mandatory both in regulatory contexts and for publication in journals. Further research is needed to determine the main reasons for selectively missing results to support the development and implementation of more specific methods for preventing selectively missing results.

This meta-research assessed methodologies used for evaluating peri-implant marginal bone levels on digital periapical radiographs in randomized clinical trials published between 2019 and 2023.

Articles were searched in four databases. Data on methods for assessing peri-implant marginal bone levels were extracted. Risk of bias assessment was performed.

During full-text reading, 108 out of 162 articles were excluded. Methodological issues accounted for these exclusions, including the absence of radiograph-type information, the lack of radiographic positioners, the missing anatomical references, and the use of panoramic radiographs or tomography. Fifty-four articles were included, most from Europe (70%) and university-based (74%). Radiographic positioners were specified in 54% of articles. Examiner calibration was unreported in 54%, with 69% lacking details. In 59%, no statistical measure assessed examiner agreement. Blinding was unreported or unused in 50%. Marginal bone level changes were the primary outcome of 61%. Most articles (59.3%) raised "some concerns" regarding bias, while 37% showed a high risk of bias, and only two articles (3.7%) demonstrated a low risk of bias.

Several limitations and areas for improvement were identified. Future studies should prioritize protocol registration, standardize radiographic acquisitions, specify examiner details, implement calibration and statistical measures for agreement, introduce blinding protocols, and maintain geometric calibration standards.

Biomedicine is organized around interventions. Despite growing concern about overtreatment in healthcare systems, not intervening can still raise questions about potential negligence and the quality of care. Based on ethnographic fieldwork with palliative care teams in England, we explore the work palliative care specialists do to reduce and sometimes halt interventions for patients at the end-of-life, in a general medical environment that is largely interventionist. We describe how judgments about what is an action or not aren't based on obvious or agreed criteria, but ultimately according to what different actors feel constitutes the best form of care. In other words, the underlying values that shape ideas of care determine how action and inaction are nominated, and not the other way around.

Increasing transparency in clinical research is crucial to avoid misleading conclusions. Registering clinical trials prior to participant enrolment is mandatory, and the publication of trial protocols could further enhance transparency. However, the impact of protocol publication on primary outcomes (PO) and sample sizes (SS) remains unclear. This study aimed to determine the rates of trial protocol publication and registration for a sample of randomized controlled trials (RCTs) and to compare the consistency of published and registered PO and SS.

A search was conducted in MEDLINE via PubMed® for RCT reports indexed in May and June 2023 across various medical specialties, focusing on general and high-impact factor journals. Data were extracted regarding trial registration, protocol publication, and comparisons were made between PO and SS in articles, registries, and published protocols.

Out of 1119 references, 589 (52.6%) were RCTs. The corresponding protocol was published for 146 RCTs (24.8%) including 40 over 140 (28.6%) (6 without end date available) after the trial had ended. Sixty-two (42.4%) protocols were published before the trial conclusion, with no significant differences between PO and SS in published protocols and their corresponding articles. Five hundred and twenty-eight (89.6%) RCTs were registered, 225 over 510 (44%) were registered before the study start with no differences in PO and SS between article and registry. Articles published in generalist or high impact factor journals were associated with higher frequencies of published protocols and trial registration and a lower frequency of difference in PO and SS between articles, registries, and published protocols.

While publishing trial protocols may enhance transparency in peer-review process, the initial registered protocol alone appears sufficient for ensuring consistency in primary outcomes and sample sizes. Protocol publication does not seem to provide additional significant benefits in terms of outcome reporting.

Large language models (LLMs) have the potential to enhance the verification of health claims. However, issues with hallucination and comprehension of logical statements require these models to be closely scrutinized in healthcare applications. We introduce CliniFact, a scientific claim dataset created from hypothesis testing results in clinical research, covering 992 unique interventions for 22 disease categories. The dataset used study arms and interventions, primary outcome measures, and results from clinical trials to derive and label clinical research claims. These claims were then linked to supporting information describing clinical trial results in scientific publications. CliniFact contains 1,970 instances from 992 unique clinical trials related to 1,540 unique publications. When evaluating LLMs against CliniFact, discriminative models, such as BioBERT with an accuracy of 80.2%, outperformed generative counterparts, such as Llama3-70B, which reached 53.6% accuracy (p-value < 0.001). Our results demonstrate the potential of CliniFact as a benchmark for evaluating LLM performance in clinical research claim verification.

This systematic review explores machine learning (ML) applications in surgical motion analysis using non-optical motion tracking systems (NOMTS), alone or with optical methods. It investigates objectives, experimental designs, model effectiveness, and future research directions. From 3632 records, 84 studies were included, with Artificial Neural Networks (38%) and Support Vector Machines (11%) being the most common ML models. Skill assessment was the primary objective (38%). NOMTS used included internal device kinematics (56%), electromagnetic (17%), inertial (15%), mechanical (11%), and electromyography (1%) sensors. Surgical settings were robotic (60%), laparoscopic (18%), open (16%), and others (6%). Procedures focused on bench-top tasks (67%), clinical models (17%), clinical simulations (9%), and non-clinical simulations (7%). Over 90% accuracy was achieved in 36% of studies. Literature shows NOMTS and ML can enhance surgical precision, assessment, and training. Future research should advance ML in surgical environments, ensure model interpretability and reproducibility, and use larger datasets for accurate evaluation.

This study evaluates the selective outcome reporting (SOR) in clinical trials on antibiotic use in third molar surgeries. It explores how SOR may bias results and affect systematic reviews, potentially leading to misinterpretations of intervention efficacy.

A search was conducted on "ClinicalTrials.gov", "Brazilian Registry of Clinical Trials", "International Clinical Trials Registry Platform" and "European Union Clinical Trials Register" using the terms "third molar" and "antibiotics" up to December 2024. Two independent researchers selected eligible clinical trials. Data were extracted from registered protocols and corresponding publications. Discrepancies were analyzed using established criteria, and the risk of bias of published articles was assessed with Risk of Bias2.

Discrepancies between protocols and publications were found in 87.5% of cases, affecting outcomes in 68.7% of studies. SOR significantly influenced results in studies with one or more discrepancies. 75% of studies assess pain post-antibiotic therapy; of those, 50% found significant results. Only 31,25% of studies showed significant reductions in trismus or edema with antibiotic use. The risk of bias varied significantly across studies.

The high rate of selective reporting stresses the need for transparent studies to clarify the role of antibiotics in the perioperative period. Researchers should adhere to best clinical practices, including protocol registration, accurate sample size calculations, and precision in reporting. Journals and reviewers must prioritize transparency to reduce bias and improve research quality.

This study emphasizes the impact of SOR in clinical trials using antibiotics in third molar surgery. Clinicians should be more cautious in reading evidence based on randomized clinical trials with SORs.

Well-targeted balance, walking, and weight-shift training can improve balance capabilities in the chronic phase of stroke. There is an urgent need for a long-term approach to rehabilitation that extends beyond the acute and subacute phases, supporting participation without increasing the demand for health care staff.

This study aims to evaluate the effectiveness of therapeutic exercise interventions with virtual reality (VR) training on balance and walking at the activity and participation levels in individuals with chronic stroke, compared with control groups receiving no treatment, conventional physical therapy, specific training, similar treatment, or identical treatment without VR.

Studies were searched across 6 databases. The inclusion criteria were as follows: Adults aged 18 years or older with a stroke diagnosis for at least 6 months (population). Therapeutic exercises within a VR environment, using VR glasses or interactive games (intervention). Control groups without the use of VR (including no treatment, conventional physical therapy, specific training, similar treatment without VR, or identical treatment without the additional use of VR; comparison). We evaluated the Berg Balance Scale score, Functional Reach Test performance, Activities-specific Balance Confidence Scale score, Six-minute Walk Test, Two-minute Walk Test, 10-meter Walk Test results, and cadence (outcome measures). We investigated randomized controlled trials (study design). A meta-analysis and a meta-regression analysis were conducted to evaluate whether the content of VR interventions or control groups, as well as the level of VR immersion used, was related to balance or walking outcomes.

A total of 43 randomized controlled trials involving 1136 participants were included in this review. The use of VR training in therapeutic exercise interventions had a large effect on balance (standardized mean difference 0.51, 95% CI 0.29-0.72; P<.001) and a moderate effect on walking (standardized mean difference 0.31, 95% CI 0.09-0.53; P=.006) in individuals with chronic stroke, compared with pooled control groups (no treatment, conventional physical therapy, specific training, similar treatment, or identical treatment without the use of VR). According to the meta-regression findings, the content of VR interventions (P=.52), the type of control groups (P=.79), and the level of VR immersion (P=.82) were not significantly related to the pooled balance or walking outcomes. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) was moderate for balance and low for walking.

Therapeutic exercise training with VR had a positive, albeit moderate, effect on balance and a low impact on walking at the level of activity (capacity), even in the chronic phase of stroke, without serious side effects. The results are applicable to working-aged stroke rehabilitees who are able to walk without assistance. Further research is needed with defined VR methods and outcomes that assess performance at the level of real-life participation.

Transparent trial conduct requires prospective registration of a randomized controlled clinical trial (RCT) before the enrollment of the first participant. We aimed to (1) estimate the proportion of RCTs that are prospectively registered and analyze the time trends and factors linked to registration timing and (2) assess the reasons for nonadherence to prospective registration and explore ways to improve compliance. We studied trials published in rheumatology as a case study.

We searched for RCTs in rheumatology published between 2009 and 2022. We conducted a multivariable logistic regression to identify factors associated with prospective trial registration. We sent a survey to investigators of trials not prospectively registered, asking about reasons for nonadherence and potential solutions.

We identified 1093 RCTs; 453 (41.4%) were not prospectively registered. Of these, 130 (11.9%) were not registered and 323 (29.5%) were retrospectively registered. Prospective registration increased by 3% annually (P < .001), with 13.3% (2 of 15) trials registered in 2009 to 73.2% (112 of 153) in 2022. In journals supporting the International Committee of Medical Journals Editors recommendations, 16% of trials published in 2022 were not prospectively registered. Prospective registration was associated with a larger sample size, multinational recruitment, and publication in higher impact journals. Investigators reported lack of knowledge or organizational problems as key reasons for retrospective registration. They suggested linking ethical approval to trial registration to ensure prospective registration.

Despite significant improvement, adherence to prospective registration remains unsatisfactory in rheumatology. Targeted strategies for journal editors, health-care professionals, and researchers may help improve trial registration.

Randomized controlled clinical trials are a research type where people are randomly assigned to different treatments to see which works best. These treatments can include drugs, surgery, medical devices, or changes in behavior. The results obtained in RCTs are essential for the advance of medicine and for making medical decisions. Randomized controlled clinical trials need to be conducted in a transparent way to provide trustworthy information and avoid misleading findings. A key aspect of transparency is registering the study details and plan in a public repository before the trial starts. This not only requires researchers to plan their study in advance but also enables the scientific community to track any change in how the study is conducted. Although registration of RCTs is recommended, it is not compulsory. Questions remain about researchers' compliance with prospective registration, and the factors that may affect it. In the present study, we systematically studied the registration practices of rheumatology RCTs published between 2009 and 2022. We reviewed how the trials were registered and used a statistical method (multivariable logistic regression) to determine what factors were linked to whether a trial was registered before it started. We also sent a questionnaire to researchers who either did not register or retrospectively registered their study, asking for their suggestions on how to improve adherence to proper registration practices. We found 1093 trials, of which 453 (41.4%) were not registered before they started. Among these, 130 (11.9%) were never registered and 323 (29.5%) were retrospectively registered. Trials with a larger number of participants, those involving recruiting centers from multiple countries, and those published in more prestigious journals were more likely to be registered in advance and adhere to transparency recommendations. Researchers who did not register their trial before it started reported that lack of awareness and organizational issues as the main reasons for not following these recommendations. They suggested that connecting ethical approval to trial registration could be a solution for ensuring adequate registration. We found that even though trial registration has improved in recent years, a considerable number of rheumatology trials are still not registered before they start. Based on our findings, we think that focusing on strategies for journal editors, health-care professionals, and researchers could help increase the number of properly registered trials.

The primary objectives were to describe characteristics of trial registration in the chronic low back pain (CLBP) field and assess the association of trial registration status (registered vs unregistered, prospectively registered vs retrospectively registered) with risk of bias, sufficient sample size, quality of reporting, and treatment effect estimates. Secondary objectives were to describe trial registration consistency with the final report and assess its association with risk of bias, sufficient sample size, and treatment effect estimates.

A cross-sectional metaepidemiological study of trials included in a large Cochrane review on exercise treatments for CLBP. We extracted relevant trial and registration information and assessed trials' risk of bias using the Cochrane Risk of Bias 1 tool. We performed descriptive analyses, logistic regressions, and subgroup meta-analyses.

We included 361 trials, of which 23.3% were prospectively registered. Registered trials had lower risk of bias (odds ratio [OR] 0.6; 95% confidence interval [CI] 0.5, 0.7) and higher reporting quality (OR 1.6; 95% CI 1.4, 1.8) than unregistered trials. Prospectively registered trials were more likely to have low risk of reporting bias (OR 2.7; 95% CI 1.2, 6.5) and higher quality of reporting (OR 1.3; 95% CI 1.1, 1.6) than retrospectively registered trials. Trial registration status was not associated with effect estimates. Among prospectively registered trials, 64.3% clearly defined primary outcome(s) in their registration, 58.3% had consistent sample sizes, and 22.6% had no evidence of selective outcome reporting. Trials that clearly defined primary outcome(s) were more likely to report larger effect estimates for pain intensity (mean difference -15.8; 95% CI -22.7, -8.9 vs -6.0; 95% CI -10.6, -1.5; Q = 6.7, P = .01), although the difference was small, the 95% CIs overlapped, and no difference was found for functional limitations.

A small proportion of trials in the CLBP field were registered prospectively and many presented registration inconsistencies. Registered trials tend to have lower risk of bias and higher quality of reporting. Policies are needed to improve prospective registration and registration consistency in the field.

Prospective trial registration is the practice of documenting the planned methods of a randomized controlled trial on a publicly available online platform (ie, website) before enrolling participants. Medical journals require trialists to prospectively register their trials to encourage the conduct of high-quality research and reduce the chance of trialists changing their research plan to report only positive or significant results (known as selective outcome reporting). We investigated whether trialists within the chronic low back pain field were registering their trials, and whether they followed their registered research plan.We used data from a large systematic review of 456 trials that tested the effectiveness of exercise as a treatment for chronic low back pain. We assessed each trials' registration status and whether prospectively registered trials had inconsistencies between their registered research plan and their research conduct (eg, evidence of selective outcome reporting). We also looked at the association among trial registration with trials' quality of reporting (ie, a marker of research transparency), risk of bias (ie, a marker of research quality), and the amount of low back pain improvement reported by the trials (ie, effect estimates).We found that less than 25% of trials were prospectively registered, and many had inconsistencies between their registered research plan and their research conduct. Overall, registered trials had lower risk of bias and higher quality of reporting. However, trial registration status and selective outcome reporting were not associated with effect estimates (the amount of back pain improvement reported by trials). Our findings highlight the need for trialists and journals to better follow trial registration guidelines and policies in the chronic low back pain field. Knowledge users should be cautious when consuming information from unregistered trials as they appear to be more likely to have quality concerns.

To study the prevalence and manifestation of selective outcome reporting (SOR) among randomized controlled trials (RCTs) published in leading dental journals, and to explore the association between SOR and potentially related factors.

We hand-searched RCTs published in the leading dental journals between 2018 and 2023. RCTs with registrations and defined primary outcomes were included, and their relevant characteristics were extracted for analysis. Discrepancies between publication and corresponding registration were compared regarding primary outcome and other study characteristics. The generalized estimating equation model was applied to identify factors associated with SOR.

Two hundred and seventy trials were included. SOR was identified in 51.5% (n = 139) of the included RCTs with the discrepancy in the assessment timing of the primary outcome as the most common manifestation (n = 86, 31.9%). Substantial discrepancies were observed regarding sample size (n = 148, 54.8%) and source of funding (n = 105, 38.9%). Sample size [odds ratio (OR) 0.61, 95% confidence interval (CI) 0.40 to 0.92], timing of registration (OR 2.10, 95% CI 1.03 to 4.31), and discrepancy in follow-up length (OR 32.01, 95% CI 11.80 to 86.83) were identified as statistically significant factors associated with SOR.

SOR was prevalent among RCTs in leading dental journals. Researchers and other stakeholders should be aware of this reporting issue and make joint efforts to improve the outcome reporting quality.

The findings of this research-on-research study indicate a substantial presence of SOR in the field of dentistry. Such bias can potentially mislead readers and distort the pooled effect estimates in evidence synthesis, ultimately influencing clinical decision-making.

Selective outcome reporting can result in overestimation of treatment effects, research waste, and reduced openness and transparency. This review aimed to examine selective outcome reporting in trials of behavioural health interventions and determine potential outcome reporting bias. A review of nine health psychology and behavioural medicine journals was conducted to identify randomised controlled trials of behavioural health interventions published since 2019. Discrepancies in outcome reporting were observed in 90% of the 29 trials with corresponding registrations/protocols. Discrepancies included 72% of trials omitting prespecified outcomes; 55% of trials introduced new outcomes. Thirty-eight percent of trials omitted prespecified and introduced new outcomes. Three trials (10%) downgraded primary outcomes in registrations/protocols to secondary outcomes in final reports; downgraded outcomes were not statistically significant in two trials. Five trials (17%) upgraded secondary outcomes to primary outcomes; upgraded outcomes were statistically significant in all trials. In final reports, three trials (7%) omitted outcomes from the methods section; three trials (7%) introduced new outcomes in results that were not in the methods. These findings indicate that selective outcome reporting is a problem in behavioural health intervention trials. Journal- and trialist-level approaches are needed to minimise selective outcome reporting in health psychology and behavioural medicine.

A core outcome set (COS) helps standardize outcome measurements across clinical trials. Although lung cancer is the leading cause of cancer-related deaths, research exploring COS implementation across lung cancer trials remains limited. We aim to analyze the uptake of the lung cancer COS and identify potential gaps in COS adherence.

On June 26, 2023, we conducted a cross-sectional analysis of clinical trials that evaluated lung cancer interventions. Our sample consisted of studies registered on ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform between September 2011 and June 2023. In a masked and duplicate fashion, investigators extracted data regarding trial characteristics and COS adoption. An interrupted time series analysis was conducted to evaluate the adherence of lung cancer COS before and after its publication.

Of the 626 observed trials, we found no overall significant difference in lung cancer COS uptake pre- and post-publication (0.01%, 95% confidence interval: -0.16% to 0.19%, p=0.85). The most frequently measured outcomes were "overall survival" (91.69%%) and "treatment-related mortalities" (54.69%). Health-related quality of life questionnaires were typically used to evaluate outcomes in the "Degree of health" domain (49.20%). Outcomes related to "time from diagnosis to treatment" (0%), "place of death" (0.16%), and "duration of time spent in the hospital at the end of life" (1.60%) were rarely measured.

Despite the advantages of COS implementation, adherence across lung cancer clinical trials remains alarmingly low-which could compromise data reliability and patient care. Our findings showcase these inconsistencies and emphasize the need for proactive approaches to improve uptake.

Low back pain (LBP) is a common condition with a significant societal burden. Manual therapy is an effective treatment for LBP and recommended in clinical practice guidelines. While the quantity of literature supporting the use of manual therapy is large, the methodological quality and transparency of this collective work are unclear.

Explore the transparency in reporting of clinical trials assessing manual therapy interventions in patients with LBP by comparing planned components in the trial registration with what was reported in the published manuscript.

Three databases were searched to identify trials assessing the treatment effect of manual therapy for LBP from January 2005 to May 2023. Studies were included if the manual therapy consisted of thrust manipulations, mobilizations or muscle energy techniques.

From 4462 studies initially identified, 167 studies remained in the final review after title, abstract and full-text review. Only 87 (52.1%) of the 167 studies were registered (n = 57 prospectively and n = 30 retrospectively). Primary outcomes in the publications were identical to the registration in 54 (62.1%) of the registered trials. Secondary outcomes in the publication were identical to the registration in 27 (31.0%) of the registered trials. The CONSORT reporting guideline was referenced in only 19 (21.8%) trials. Multiple discrepancies between registration and publication were noted for primary and secondary outcomes. All trials had eligibility criteria in the registration that matched their corresponding manuscript, while only four (4.6%) trial registrations addressed any type of statistical analysis plan.

Approximately half of the trials were not registered. Of those registered, only half were registered prospectively. Substantial discrepancies existed between registered and published outcomes that were never addressed by the authors, raising questions about potential bias. Transparency can be improved through more stringent requirements during manuscript submission to journals, and better reporting of the rationale for discrepancies between registration and publication.

Previous research has raised concerns regarding inconsistencies between reported and pre-specified outcomes in randomized controlled trials (RCTs) across various biomedical disciplines. However, studies examining whether similar discrepancies exist in RCTs focusing on gastrointestinal and liver diseases are limited. This study aimed to assess the extent of discrepancies between registered and published primary outcomes in RCTs featured in journals specializing in gastroenterology and hepatology.

We retrospectively retrieved RCTs published between January 1, 2017 and December 31, 2021 in the top three journals from each quartile ranking of the 2020 Journal Citation Reports within the "Gastroenterology and Hepatology" subcategory. We extracted data on trial characteristics, registration details, and pre-specified versus published primary outcomes. Pre-specified primary outcomes were retrieved from the World Health Organization's International Clinical Trials Registry Platform. Only trials reporting specific primary outcomes were included in analyzing primary outcome discrepancies. We also assessed whether there was a potential reporting bias that deemed to favor statistically significant outcomes. Statistical analyses included chi-square tests, Fisher's exact tests, univariate analyses, and logistic regression.

Of 362 articles identified, 312 (86.2%) were registered, and 79.8% of the registrations (249 out of 312) were prospective. Among the 285 trials reporting primary outcomes, 76 (26.7%) exhibited at least one discrepancy between registered and published primary outcomes. The most common discrepancies included different assessment times for the primary outcome (n = 32, 42.1%), omitting the registered primary outcome in publications (n = 21, 27.6%), and reporting the registered secondary outcomes as primary outcomes (n = 13, 17.1%). Univariate analyses revealed that primary outcome discrepancies were lower in the publication year 2020 compared to year 2021 (OR = 0.267, 95% CI: 0.101, 0.706, p = 0.008). Among the 76 studies with primary outcome discrepancies, 20 (26.3%) studies were retrospectively registered, and 32 (57.1%) of the prospectively registered trials with primary outcome discrepancies showed statistically significant results. However, no significant differences were found between journal quartiles regarding primary outcome consistency and potential reporting bias (p = 0.14 and p = 0.28, respectively).

This study highlights the disparities between registered and published primary outcomes in RCTs within gastroenterology and hepatology journals. Attention to factors such as the timing of primary outcome assessments in published trials and the consistency between registered and published primary outcomes is crucial. Enhanced scrutiny from journal editors and peer reviewers during the review process is necessary to ensure the reliability of gastrointestinal and hepatic trials.

Early in the COVID-19 pandemic, numerous clinical trials were initiated. Although concerns were raised regarding the quality of the trials, the eventual research output yielded from the trials remains unknown. The objective of this study was to include all clinical trials registered on ClinicalTrials.gov during the first 6 months of the pandemic and assess if and where their results had been reported, their completion and discontinuation rates, achieved enrolment and changes made to the primary outcome after trial registration.

We included all interventional studies related to COVID-19 first registered on ClinicalTrials.gov between 1 January 2020 and 1 July 2020. We systematically searched for trial results, reported through 15 May 2023, in scientific publications, preprints and ClinicalTrials.gov. We assessed the achieved trial enrolment, trial discontinuation (reaching <90% of target enrolment), and whether the primary outcome had been changed as compared with the initial protocol registration.

The 775 clinical trials included in the analysis planned to enrol 238 933 (median (IQR) 120 (60, 304) patients; 355 (46%) of the trials had reported results, and 283 (36%) were published in a scientific journal. In the reported trials, the total enrolment was 95 332 (median (IQR) 105 (45, 222) patients. 186 (24%) trials were completed, and 169 (22%) trials were discontinued, with slow recruitment being the most stated reason for discontinuation (9% of all trials, although 30% of the discontinued trials did not report a reason). 117 (33%) of the reported trials had changed their primary outcome. In total, 157 (20%) trials were completed and published in a scientific journal, of which 105 enrolled ≥100 patients and 103 had not changed the primary outcome. 63 completed and published trials enrolled ≥100 patients and had not changed the primary outcome.

Most clinical trials of COVID-19 registered at ClinicalTrials.gov during the first 6 months of the pandemic remained unreported or had been discontinued. Many of the trials whose results had been reported enrolled few patients and changed the primary outcome after trial registration.

Accurate reporting of outcomes is crucial for interpreting the results of randomized controlled trials (RCTs). However, selectively reporting outcomes in publications to achieve researchers' anticipated results still occurs frequently. This study aims to investigate the prevalence of selective reporting of outcomes in RCTs on treating acute ischemic stroke (AIS), identify factors contributing to this issue, and assess its potential impact on the degree and direction of intervention effect.

A search was conducted in MEDLINE, Embase, and the Cochrane Library to collect interventional RCTs on AIS published from 2020 to 2022. Full texts of RCTs were reviewed, and only those reporting International Clinical Trials Registry Platform primary registry numbers were included. Registration information of the RCTs was extracted from the registry platforms and compared with the publications' details to assess the selective reporting of outcomes. Bayesian multilevel logistic regression was used to analyze the reasons behind selective reporting.

Among the total of 159 AIS RCTs identified, 82 (51.6%) were ultimately included, as they reported registration numbers, which encompassed 819 outcomes. Among them, 72 RCTs (87.8%) and 497 outcomes (60.7%) exhibited selective reporting. Omission-type selective reporting (downgrading, omitting, or ambiguously reporting) accounted for 36.4%, while addition-type selective reporting (upgrading, adding, or altering the measurement scope of outcomes) comprised 63.6%. Omission-type selective reporting correlated with negative results (OR: 7.39; 95% CI: 4.08-13.44), whereas addition-type selective reporting correlated with positive results (OR: 2.07; 95% CI: 1.34-3.26) and publication in journals that are not in the top quartile of the Journal Citation Reports (OR: 2.48; 95% CI: 1.15-5.38).

Registered interventional AIS RCTs still face significant issues regarding selective reporting of outcomes. Therefore, it is necessary to further evaluate the influence of selective reporting bias on the positive results obtained from individual AIS RCTs and the systematic reviews based on these RCTs.

In medical research, publication bias (PB) poses great challenges to the conclusions from systematic reviews and meta-analyses. The majority of efforts in methodological research related to classic PB have focused on examining the potential suppression of studies reporting effects close to the null or statistically non-significant results. Such suppression is common, particularly when the study outcome concerns the effectiveness of a new intervention. On the other hand, attention has recently been drawn to the so-called inverse publication bias (IPB) within the evidence synthesis community. It can occur when assessing adverse events because researchers may favor evidence showing a similar safety profile regarding an adverse event between a new intervention and a control group. In comparison to the classic PB, IPB is much less recognized in the current literature; methods designed for classic PB may be inaccurately applied to address IPB, potentially leading to entirely incorrect conclusions. This article aims to provide a collection of accessible methods to assess IPB for adverse events. Specifically, we discuss the relevance and differences between classic PB and IPB. We also demonstrate visual assessment through contour-enhanced funnel plots tailored to adverse events and popular quantitative methods, including Egger's regression test, Peters' regression test, and the trim-and-fill method for such cases. Three real-world examples are presented to illustrate the bias in various scenarios, and the implementations are illustrated with statistical code. We hope this article offers valuable insights for evaluating IPB in future systematic reviews of adverse events.

We aimed to compare the results of phase III and IV clinical trials examining drugs to treat multiple sclerosis (MS) registered at ClinicalTrials.gov to those published in peer-reviewed journals.

After identifying trials registered at ClinicalTrials.gov, consecutive searches were conducted in PubMed, EMBASE and Google Scholar for matching publications. Information regarding participants and efficacy and safety results was extracted and compared. The degree of consistency was classified as 'concordant', 'discrepant' or 'not comparable'. The Kaplan-Meier method was used to model time to reporting.

In total, 65 trials were appraised. The median time from completion to reporting was shorter for ClinicalTrials.gov (16.4 vs 27.3 months; p = 0.010). Information availability was generally higher in journals except for serious adverse events (SAEs) (86.2% vs 100.0%, p = 0.029) and their description (78.2% vs 100.0%, p < 0.001). However, 45 trials had at least one reporting discrepancy (69.2%). Three studies omitted one or more primary outcomes in the matching journal publication. Regarding safety results, the lowest consistencies were found for causes of death (60.0%) and description of SAEs (27.9%).

Consulting both ClinicalTrials.gov and journals increases the accessibility to MS clinical trial results. Some data were frequently missing or disagreed between sources, raising concerns about transparency and generalizability of results.

Dissemination and outcome reporting biases are a significant problem in clinical research, with far-reaching implications for both scientific understanding and clinical decision-making. This study investigates the prevalence of dissemination- and outcome reporting biases in registered interventional malaria research.

All malaria interventional trials registered on ClinicalTrials.gov from 2010 to 2020 were identified. Subsequently, publications that matched the registration were searched. The primary outcome measures were the percentage of registered studies that resulted in subsequent publication of study results, the concordance between registered outcomes, and reported outcomes. Secondary outcomes were compliance with WHO standards for timely publication (issued in 2017) of summary study results in the respective trial registry (within 12 months of study completion) or peer-reviewed publication (within 24 months of study completion) was evaluated.

A total of 579 trials were identified on ClinicalTrials.gov, of which 544 met the inclusion criteria. Notably, almost 36.6% of these trials (199/544) were registered retrospectively, with 129 (23.7%) registered after the first patient enrolment and 70 (12.9%) following study completion. Publications were identified for 351 out of 544 registered trials (64.5%), involving 1,526,081 study participants. Conversely, publications were not found for 193 of the 544 registrations (35.5%), which aimed to enrol 417,922 study participants. Among these 544 registrations, 444 (81.6%) did not meet the WHO standard to post summary results within 12 months of primary study completion (the last visit of the last subject for collection of data on the primary outcome), while 386 out of 544 registrations (71.0%) failed to publish their results in a peer-reviewed journal within 24 months of primary study completion. Discrepancies were noted in the reported primary outcomes compared to the registered primary outcomes in 47.6% (222/466) of the published trials, and an even higher discordance rate of 73.2% (341/466 publications) for secondary outcomes.

Non-dissemination remains a significant issue in interventional malaria research, with most trials failing to meet WHO standards for timely dissemination of summary results and peer-reviewed journal publications. Additionally, outcome reporting bias is highly prevalent across malaria publications. To address these challenges, it is crucial to implement strategies that enhance the timely reporting of research findings and reduce both non-dissemination and outcome reporting bias.

Numerous studies have examined epilepsy surgery outcomes, yet the variability in the level of detail reported hampers our ability to apply these findings broadly across patient groups. Established reporting standards in other clinical research fields enhance the quality and generalizability of results, ensuring that the insights gained from studying these surgeries can benefit future patients effectively. This study aims to assess current reporting standards for epilepsy surgery research and identify potential gaps and areas for enhancement.

The Enhancing the Quality and Transparency of Health Research (EQUATOR) repository was accessed from inception to April 27, 2023, yielding 561 available reporting standards. Reporting standards were manually reviewed in duplicate independently for applicability to epilepsy and/or neurosurgery research. The reporting standards had to cover the following aspects in human studies: (1) reporting standards for epilepsy/epilepsy surgery and (2) reporting standards for neurosurgery. Disagreements were resolved by a third author. The top five neurosurgery, neurology, and medicine journals were also identified through Google Scholar's citation index and examined to determine the relevant reporting standards they recommended and whether those were registered with EQUATOR.

Of the 561 EQUATOR reporting standards, 181 were pertinent to epilepsy surgery. One was related to epilepsy, six were specific to surgical research, and nine were related to neurological/neurosurgical research. The remaining 165 reporting standards were applicable to research across various disciplines and included but were not limited to CONSORT (Consolidated Standards of Reporting Trails), STROBE (Strengthening the Reporting of Observational Studies in Epidemiology), and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). None of these required reporting factors associated with epilepsy surgery outcomes, such as duration of epilepsy or magnetic resonance imaging findings.

Reporting standards specific to epilepsy surgery are lacking, reflecting a gap in standards that may affect the quality of publications. Improving this gap with a set of specific reporting standards would ensure that epilepsy surgery studies are more transparent and rigorous in their design.

Industry sponsorship is an important source of funding for atrial fibrillation (AF) clinical trials, the implications of which have not been analyzed.

The purpose of this study was to determine the characteristics of contemporary AF clinical trials and to evaluate their association with funding source.

We systematically assessed all completed AF trials registered in the ClinicalTrials.gov database between conception to October 31, 2023, and extracted publicly available information including funding source, trial size, demographic distribution, intervention, location, and publication status. Trial characteristics were compared using the Wilcoxon rank-sum test and Fisher exact test for continuous and categorical variables, respectively.

Of the 253 clinical trials assessed, 171 (68%) reported industry funding. Industry funding was associated with a greater median number of patients enrolled (172 vs 80; P <.001), publication rate (56.7% vs 42.7%; P = .04), probability of being product-focused (48.0% vs 24.4%; P <.001), and multicontinental recruitment location (25.2% vs 2.4%; P <.001) when compared to nonindustry-funded trials. However, industry funding was not associated with a significant difference in median impact factor (7.7 vs 7.7; P = .723). The overall proportion of industry-funded trials did not change over time (P = 1).

Industry-funded clinical trials in AF often are larger, more frequently published, multicontinental, and product-focused. Industry funding was found to be associated with significant differences in study enrollment and publication metrics.

Immune checkpoint inhibitors (ICI) have transformed the management of cancer, particularly for older adults, who constitute a majority of the global cancer patient population. This study aimed to assess the inclusion, characteristics, and reporting of older adults enrolled in Food and Drug Administration (FDA) registration clinical trials of ICI between 2018 and 2022. Clinical trials of ICI leading to an FDA approval in solid tumor oncology between 2018 and 2022 were included. Primary study reports and all available secondary publications were assessed. The availability and completeness of older subgroup data for protocol-defined clinical efficacy endpoints, health-related quality of life (HRQOL) and toxicity outcomes, and baseline characteristics were assessed according to predefined criteria which categorized reporting completeness hierarchically in relation to the availability of published data, including effect size, sample size, and measures of precision. 53 registration trials were included, involving a total of 37,094 participants. Most trials (64.2%) were of ICI combination therapy. 42.3% of patients were aged≥65 years; 11.1% were aged≥75. No trials specified an upper age limit for eligibility. 98.1% of trials excluded patients with European Cooperative Oncology Group performance status>1. 87.2% of primary efficacy endpoints and 17.9% of secondary efficacy endpoints were reported completely for older adults. Five studies (9.4%) reported baseline characteristics, three (6.1%) reported HRQOL assessments, and four (7.5%) reported toxicity outcomes completely among older subgroups. No trials conducted baseline geriatric assessments or reported geriatric-specific symptoms or quality of life scales. This analysis highlights significant deficits in the enrollment and reporting of older subgroups in pivotal trials of ICI therapy. The findings highlight an urgent need for improved reporting and inclusion standards in clinical trials of ICI to better inform treatment decisions for older adults.

Cronobacter sakazakii is a potentially pathogenic bacterium that is resistant to osmotic stress and low aw, and capable of persisting in a desiccated state in powdered infant milks. It is widespread in the environment and present in various products. Despite the low incidence of cases, its high mortality rates of 40 to 80 % amongst neonates make it a microorganism of public health interest. This current study performed a comparative assessment between current reduction methods applied for C. sakazakii in various food matrices, indicating tendencies and relevant parameters for process optimization. A systematic review and meta-analysis were conducted, qualitatively identifying the main methods of inactivation and control, and quantitatively evaluating the effect of treatment factors on the reduction response. Hierarchical clustering dendrograms led to conclusions on the efficiency of each treatment. Review of recent research trend identified a focus on the potential use of alternative treatments, with most studies related to non-thermal methods and dairy products. Using random-effects meta-analysis, a summary effect-size of 4-log was estimated; however, thermal methods and treatments on dairy matrices displayed wider dispersions - of τ2 = 8.1, compared with τ2 = 4.5 for vegetal matrices and τ2 = 4.0 for biofilms. Meta-analytical models indicated that factors such as chemical concentration, energy applied, and treatment time had a more significant impact on reduction than the increase in temperature. Non-thermal treatments, synergically associated with heat, and treatments on dairy matrices were found to be the most efficient.

When researchers fail to report their findings or only report some of their findings, it can make it difficult for clinicians to provide effective intervention recommendations. However, no one has examined whether this is a problem in studies of early childhood autism interventions. We studied how researchers that study early childhood autism interventions report their findings. We found that most researchers did not register their studies when they were supposed to (before the start of the study), and that many researchers did not provide all of the needed information in the registration. We also found that researchers frequently did not publish their findings when their studies were complete. When we looked at published reports, we found that many of the studies did not report enough information, and that many studies were reported differently from their registrations, suggesting that researchers were selectively reporting positive outcomes and ignoring or misrepresenting less positive outcomes. Because we found so much evidence that researchers are failing to report their findings quickly and correctly, we suggested some practical changes to make it better.

Despite clearly established guidelines, recent audits have found the conduct and reporting of systematic reviews and meta-analyses (SRMAs) within neurosurgery to be relatively lackluster in methodological rigor and compliance. Protocols of SRMAs allow for planning and documentation of review methods, guard against arbitrary decision-making during the review process, and enable readers to assess for the presence of selective reporting. To aid transparency, authors should provide sufficient detail in their protocol so that the readers could reproduce the study themselves. Development of our guideline drew heavily from the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P) initiative. The objective of this article is not to enumerate every detail of this checklist, but to provide guidance to authors preparing their protocol, with examples, for a systematic review in neurosurgery. Particularly, we emphasize on the PICO framework - population (P), interventions (I), comparators (C), outcomes (O) - which is central to constructing a clinical question, defining the scope of the systematic review, defining and prioritizing the primary outcome, to specifying the eligibility criteria, designing the search strategy, and identifying potential sources of heterogeneity. We encourage our readers to make use of this guideline alongside the PRISMA-P 2015 statement, when drafting and appraising systematic review protocols.

Neurosurgeons are inundated with the Herculean task to keep abreast with the rapid pace at which clinical research is proliferating. Systematic reviews and meta-analyses (SRMAs) have consequently surged in popularity because when executed properly, they constitute the highest level of evidence, and may save busy neurosurgeons many hours of combing the literature. Well-executed SRMAs may prove instructive for clinical practice, but poorly conducted reviews sow confusion and may potentially cause harm. Unfortunately, many SRMAs within neurosurgery are relatively lackluster in methodological rigor. When neurosurgeons apply the results of an SRMA to patient care, they should start by evaluating the extent to which the employed methods have likely protected against misleading results. The present article aims to educate the reader about how to interpret an SRMA, to assess the potential relevance of its results in the special context of the neurosurgical patient population.

There is a need to consolidate reporting guidance for nutrition randomised controlled trial (RCT) protocols. The reporting completeness in nutrition RCT protocols and study characteristics associated with adherence to SPIRIT and TIDieR reporting guidelines are unknown. We, therefore, assessed reporting completeness and its potential predictors in a random sample of published nutrition and diet-related RCT protocols.

We conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis.

The majority of protocols included adults and elderly as their study population (n = 73; 36.5%), supplementation as intervention (n = 96; 48.0%), placebo as comparator (n = 89; 44.5%), and evaluated clinical status as the outcome (n = 80; 40.0%). Most protocols described a parallel RCT (n = 188; 94.0%) with a superiority framework (n = 141; 70.5%). Overall reporting completeness was 52.0% (SD = 10.8%). Adherence to SPIRIT items ranged from 0% (n = 0) (data collection methods) to 98.5% (n = 197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n = 11) (materials used in the intervention) to 98.5% (n = 197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [β = 0.53 (95%CI: 0.28-0.78)], most recent published protocols [β = 3.19 (95%CI: 0.24-6.14)], request of reporting guideline checklist during the submission process by the journal [β = 6.50 (95%CI: 2.56-10.43)] and mention of SPIRIT by the authors [β = 5.15 (95%CI: 2.44-7.86)] are related to higher reporting completeness scores.

Reporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals' endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols.

Several recent studies have explored the relationships between mindfulness and time perception, an area of research that has become increasingly popular in the last 10-15 years. In this article, we present a systematic integrative review of the evidence on this subject. We also integrate the field's findings into a conceptual framework which considers the multifaceted nature of both mindfulness, and time perception research. To identify the relevant literature, we searched the following databases using relevant keywords: PsycINFO; Medline; EBSCO Host Psychology and Behavioral Sciences Collection; and Web of Science. These searches were last performed on the 4th of May 2022, and additional hand searches were also conducted. To be included, articles had to be in English and contain original data about the potential relationship(s) between mindfulness and time perception. Articles which did not present usable data about the relationship(s) between the variables of interest were excluded. In total, 47 research articles were included in the review (combined sample size of ∼5800 participants). Risks of bias in the selected studies were evaluated using two separate assessment tools designed for this purpose. Through an integrative narrative synthesis, this article reviews how mindfulness may relate to time perception for various reference frames, and for various time perception measures and methods. It also provides new insights by exploring how a wide range of findings can be integrated into a coherent whole, in light of some relevant time perception models and mindfulness theories. Altogether, the reviewed data suggest the existence of complex and multifaceted relationships between mindfulness and time perception, highlighting the importance of considering many factors when planning research or interpreting data in this field. Limitations of the current review include the scarceness of data for certain categories of findings, and the relatively low prevalence of studies with a randomized controlled design in the source literature. This research was partly funded by a grant from the Natural Science and Engineering Research Council of Canada.

To assess compliance with statutory requirements to register and report outcomes in interventional trials of mesenchymal stromal cells (MSCs) for musculoskeletal disorders and to describe the trials' clinical and design characteristics.

A systematic review of published trials and trials submitted to public registries.

The databases Medline, Cochrane Library and McMaster; six public clinical registries. All searches were done until 31 January 2023.

Trials submitted to registries and completed before January 2021. Prospective interventional trials published in peer-reviewed journals.

The first author searched for trials that had (1) posted trial results in a public registry, (2) presented results in a peer-reviewed publication and (3) submitted a pretrial protocol to a registry before publication. Other extracted variables included trial design, number of participants, funding source, follow-up duration and cell type.

In total 124 trials were found in registries and literature databases. Knee osteoarthritis was the most common indication. Of the 100 registry trials, 52 trials with in total 2 993 participants had neither posted results in the registry nor published results. Fifty-two of the registry trials submitted a protocol retrospectively. Forty-three of the 67 published trials (64%) had registered a pretrial protocol. Funding source was not associated with compliance with reporting requirements. A discrepancy between primary endpoints in the registry and publication was found in 16 of 25 trials. In 28% of trials, the treatment groups used adjuvant therapies. Only 39% of controlled trials were double-blinded.

A large proportion of trials failed to comply with statutory requirements for the registration and reporting of results, thereby increasing the risk of bias in outcome assessments. To improve confidence in the role of MSCs for musculoskeletal disorders, registries and medical journals should more rigorously enforce existing requirements for registration and reporting.

In Part I of this series, we provide guidance for preparing a systematic review protocol. In this article, we highlight important steps and supplement with exemplars on conducting and reporting the results of a systematic review. We suggest how authors can manage protocol violations, multiplicity of outcomes and analyses, and heterogeneity. The quality (certainty) of the evidence and strength of recommendations should follow the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. It is our goal that Part II of this series provides valid guidance to authors and peer reviewers who conduct systematic reviews to adhere to important constructs of transparency, structure, reproducibility, and accountability. This will likely result in more rigorous systematic reviews being submitted for publication to the journals like Regional Anesthesia & Pain Medicine and Anesthesia & Analgesia.

The aim of this study is to examine which interventions lead to clinically significant weight loss among people with physical disabilities.

We systematically searched three electronic databases (PubMed, Scopus, and CENTRAL) including studies until May 2022 to find randomized controlled trials on behavioral interventions and weight-related outcomes in people with physical disabilities. Pharmacological or surgical interventions were excluded. Study quality was evaluated using the Cochrane Risk of Bias Tool. Interventions were grouped as dietary, physical activity, education/coaching, or multi-component. Mean weight changes, standard deviations, confidence intervals, and effect sizes were extracted or calculated for assessment of the intervention effect.

Sixty studies involving 6,511 participants were included in the qualitative synthesis. Most studies (n = 32) included multi-component interventions, incorporating dietary and physical activity components. Limited evidence suggests that extensive dietary interventions or long-term multi-component interventions might lead to a clinically relevant weight reduction of at least 5% for older individuals (age > 50) with mild-to-moderate mobility impairments.

Due to the high heterogeneity of studies and low study quality, it can be assumed that the range of applicability of the findings is questionable. Further research should examine younger age groups (i.e., children, adolescents, and adults under 40 years) and compare different settings such as schools, clinics, nursing homes, and assisted living facilities.

Selective outcome reporting (SOR) can threaten the validity of results found in clinical trials. Some studies in the literature have analyzed SOR in dentistry, but there is no study that has observed SOR in clinical trials in oral and maxillofacial surgery. Impacted third molar surgery is one of the most used models in clinical trials to study mainly analgesic and anti-inflammatory drug interventions. Our study aimed to evaluate the prevalence of SOR in publications employing the third molar extraction clinical trial model, and to verify whether there was an association between the statistical significance of outcomes and other characteristics that could lead to SOR. A systematic search was performed on the ClinicialTrials.gov platform for randomized clinical trial protocols, using the condition of third molar extraction. The corresponding published articles were sourced in PubMed, Scopus, and Embase databases, and compared with the registered protocols regarding the methodological data, in terms of: sample calculation, primary outcome identification, end-point periods, insertion of new outcomes in the publication, and results of outcomes. 358 protocol records were retrieved; 87 presented their corresponding articles. SOR was identified in 28.74% of the publications, and had a significant relationship with changes in the protocol, insertions of new outcomes, and discrepancies in the types of study. General risk of bias was found to be low. There were associations between SOR and the discrepancies in terms of the type of study, the choice of new outcome, and changes in the history of protocol records. The prevalence of SOR in clinical research using the third molar extraction surgery model is moderate. The quality of the scientific reporting of the results and, consequently, the certainty of evidence relating to the intervention tested can be overstated, increasing the chances of misinterpretation by health professionals.