The reporting quality of randomized controlled trials in Chinese herbal medicine (CHM) formulas for diabetes based on the consort statement and its extension for CHM formulas.

Background: This study aimed to assess the overall reporting quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) formulas for patients with diabetes, and to identify factors associated with better reporting quality. Methods: Four databases including PubMed, Embase, Cochrane Library and Web of Science were systematically searched from their inception to December 2022. The reporting quality was assessed based on the Consolidated Standards of Reporting Trials (CONSORT) statement and its CHM formula extension. The overall CONSORT and its CHM formula extension scores were calculated and expressed as proportions separately. We also analyzed the pre-specified study characteristics and performed exploratory regressions to determine their associations with the reporting quality. Results: Seventy-two RCTs were included. Overall reporting quality (mean adherence) were 53.56% and 45.71% on the CONSORT statement and its CHM formula extension, respectively. The strongest associations with reporting quality based on the CONSORT statement were multiple centers and larger author numbers. Compliance with the CHM formula extension, particularly regarding the disclosure of the targeted traditional Chinese medicine (TCM) pattern (s), was generally insufficient. Conclusion: The reporting quality of RCTs in CHM formulas for diabetes remains unsatisfactory, and the adherence to the CHM formula extension is even poorer. In order to ensure transparent and standardized reporting of RCTs, it is essential to advocate for or even mandate adherence of the CONSORT statement and its CHM formula extension when reporting trials in CHM formulas for diabetes by both authors and editors.

Self-reporting with checklists in artificial intelligence research on medical imaging: a systematic review based on citations of CLAIM.

OBJECTIVE: To evaluate the usage of a well-known and widely adopted checklist, Checklist for Artificial Intelligence in Medical imaging (CLAIM), for self-reporting through a systematic analysis of its citations. METHODS: Google Scholar, Web of Science, and Scopus were used to search for citations (date, 29 April 2023). CLAIM's use for self-reporting with proof (i.e., filled-out checklist) and other potential use cases were systematically assessed in research papers. Eligible papers were evaluated independently by two readers, with the help of automatic annotation. Item-by-item confirmation analysis on papers with checklist proof was subsequently performed. RESULTS: A total of 391 unique citations were identified from three databases. Of the 118 papers included in this study, 12 (10%) provided a proof of self-reported CLAIM checklist. More than half (70; 59%) only mentioned some sort of adherence to CLAIM without providing any proof in the form of a checklist. Approximately one-third (36; 31%) cited the CLAIM for reasons unrelated to their reporting or methodological adherence. Overall, the claims on 57 to 93% of the items per publication were confirmed in the item-by-item analysis, with a mean and standard deviation of 81% and 10%, respectively. CONCLUSION: Only a small proportion of the publications used CLAIM as checklist and supplied filled-out documentation; however, the self-reported checklists may contain errors and should be approached cautiously. We hope that this systematic citation analysis would motivate artificial intelligence community about the importance of proper self-reporting, and encourage researchers, journals, editors, and reviewers to take action to ensure the proper usage of checklists. CLINICAL RELEVANCE STATEMENT: Only a small percentage of the publications used CLAIM for self-reporting with proof (i.e., filled-out checklist). However, the filled-out checklist proofs may contain errors, e.g., false claims of adherence, and should be approached cautiously. These may indicate inappropriate usage of checklists and necessitate further action by authorities. KEY POINTS: • Of 118 eligible papers, only 12 (10%) followed the CLAIM checklist for self-reporting with proof (i.e., filled-out checklist). More than half (70; 59%) only mentioned some kind of adherence without providing any proof. • Overall, claims on 57 to 93% of the items were valid in item-by-item confirmation analysis, with a mean and standard deviation of 81% and 10%, respectively. • Even with the checklist proof, the items declared may contain errors and should be approached cautiously.

Evaluation of spin in reviews of biodegradable balloon spacers for massive irreparable rotator cuff tears.

HYPOTHESIS: Clinical studies are often at risk of spin, a form of bias where beneficial claims are overstated while negative findings are minimized or dismissed. Spin is often more problematic in abstracts given their brevity and can result in the misrepresentation of a study's actual findings. The goal of this study is to aggregate primary and secondary studies reporting the clinical outcomes of the use of subacromial balloon spacers in the treatment of massive irreparable rotator cuff tears to identify the incidence of spin and find any significant association with study design parameters. MATERIALS AND METHODS: This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Independent searches were completed on 2 databases (PubMed and Embase) for primary studies, systematic and current concepts reviews, and meta-analyses and the results were compiled. Two authors independently screened the studies using a predetermined inclusion criteria and aggregated data including titles, publication journals and years, authors, study design, etc. Each study was independently assessed for the presence of 15 different types of spin. Statistical analysis was conducted to identify associations between study characteristics and spin. RESULTS: Twenty-nine studies met the inclusion criteria for our analysis, of which 10 were reviews or meta-analyses and 19 were primary studies. Spin was identified in every study except for 2 (27/29, 93.1%). Type 3 spin, "Selective reporting of or overemphasis on efficacy outcomes or analysis favoring the beneficial effect of the experimental intervention" and type 9 spin, "Conclusion claims the beneficial effect of the experimental treatment despite reporting bias" were most frequently noted in our study, both observed in 12/29 studies (41.4%). Date of publication, and adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses or "The International Prospective Register of Systematic Reviews" were study characteristics associated with a higher rate of certain types of spin. There was a statistically significant association between disclosure of external study funding source and the presence of spin type 4, but none of the other forms of spin. CONCLUSION: Spin is highly prevalent in the abstracts of primary studies, systematic reviews, and meta-analyses discussing the use of subacromial balloon spacer technology in the treatment of massive irreparable rotator cuff tears. Our findings revealed that spin in the abstract tended to favor the balloon spacer intervention. Further efforts are required in the future to mitigate spin within the abstracts of published manuscripts.

A Comparative Study on the Quality of MRI Reporting in Primary Rectal Cancer.

Background Rectal cancer is a widespread health concern in the UK, and MRI is vital for accurate diagnosis and effective treatment. To enhance the quality of MRI reports for rectal cancer, structured reporting can be utilized. Despite the existence of global guidelines and templates, there is a lack of use for standardized templates. Thus, this study seeks to assess and compare the quality of MRI reports in free text style for rectal cancer at a single hospital with international recommendations. Methodology We conducted a retrospective cohort study on adult patients diagnosed with primary rectal cancer and underwent an MRI of the rectum/pelvis. The study aimed to identify and compare the difference in reporting quality between in-house GI radiologists and out-of-hours outsourced reporting agencies. The quality of reporting was identified based on at least fifteen selected features recommended by the European Society of Gastrointestinal and Abdominal Radiology and the Society of Abdominal Radiology. The study was performed in a General and Colorectal Surgery Department in the North East of England. Results The study retrospectively analysed 94 reports of primary rectal cancer patients over three years. The quality of reporting was compared between in-house GI radiologists and out-of-hours outsourced reporting agencies. The results showed that in-house radiologists had better reporting quality than outsourced agencies in terms of TNM stage (TNM is a notation system that describes the stage of cancer), predicted extramural venous invasion (EMVI), mesorectal fascia involvement (MRF), T stage, and shape. No statistical significance was found for metastasis, node status, further MRF description, peritoneal reflection, or MRI signal. Conclusion The study found that local GI radiologists had better quality reporting than outsourced agencies for rectal cancer MRI reports, but still missed important features. A unified structured reporting template is recommended to improve the quality of MRI reporting for rectal cancer.

Evaluation of spin in systematic reviews on the use of tendon transfer for massive irreparable rotator cuff tears.

PURPOSE: To identify, describe and account for the incidence of spin in systematic reviews and meta-analyses of tendon transfer for the treatment of massive, irreparable rotator cuff tears. The secondary objective was to characterize the studies in which spin was identified and to determine whether identifiable patterns exist among studies with spin. METHODS: This study was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Each abstract was assessed for the presence of the 15 most common types of spin derived from a previously established methodology. General data that were extracted included study title, authors, publication year, journal, level of evidence, study design, funding source, reported adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, preregistration of the study protocol, and methodologic quality per A Measurement Tool to Assess Systematic Reviews Version 2 (AMSTAR 2). RESULTS: The search yielded 53 articles, of which 13 were included in the final analysis. Articles were excluded if they were not published in a peer reviewed journal, not written in English, utilized cadaveric or nonhuman models, or lacked an abstract with accessible full text. 53.8% (7/13) of the included studies contained at least 1 type of spin in the abstract. Type 5 spin ("The conclusion claims beneficial effect of the experimental treatment despite a high risk of bias in primary studies") was the most common, appearing in 23.1% (3/13) of included abstracts. Nine of the spin categories did not appear in any of the included abstracts. A lower AMSTAR 2 score was significantly associated with the presence of spin in the abstract (P < .006). CONCLUSION: Spin is highly prevalent in the abstracts of systematic reviews and meta-analyses concerning tendon transfer for massive rotator cuff tears. A lower overall AMSTAR 2 rating was associated with a higher incidence of spin. Future studies should continue to explore the prevalence of spin in orthopedic literature and identify any factors that may contribute to its presence.

Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications.

Introduction: Non-pharmacological invasive interventions in cardiology are complex and often inadequately reported. Template for Intervention Description and Replication (TIDieR) checklist and guide were developed to aid reporting and assessment of non-pharmacological interventions. The aim of our study was to assess the completeness of describing invasive cardiology interventions in clinical trials at the level of trial registration and corresponding journal article publication. Methodology: We searched for clinical trials in invasive cardiology registered in Clinicaltrials.gov and corresponding journal publications. We used the 10-item TIDieR checklist for registries and 12-item checklist for journal publications. Results: Out of 7,017 registry items retrieved by our search, 301 items were included in the analysis. The search for corresponding published articles yielded 192 journal publications. The majority of trials were funded by the industry and were medical device trials. The median number of reported TIDieR items was 4.5 (95% CI 4.49-4.51) out of 10, and while the corresponding journal articles reported 6.5 (95% CI 6.0-6.5) out of 12 TIDieR items. Conclusion: Registration and reporting of invasive cardiology trials is often incomplete and adequate detailed description of the interventions is not provided. TIDieR checklist is an important tool which should be used to ensure rigorous reporting of non-pharmacological interventions in cardiology.

How should studies using AI be reported? lessons from a systematic review in cardiac MRI.

Recent years have seen a dramatic increase in studies presenting artificial intelligence (AI) tools for cardiac imaging. Amongst these are AI tools that undertake segmentation of structures on cardiac MRI (CMR), an essential step in obtaining clinically relevant functional information. The quality of reporting of these studies carries significant implications for advancement of the field and the translation of AI tools to clinical practice. We recently undertook a systematic review to evaluate the quality of reporting of studies presenting automated approaches to segmentation in cardiac MRI (Alabed et al. 2022 Quality of reporting in AI cardiac MRI segmentation studies-a systematic review and recommendations for future studies. Frontiers in Cardiovascular Medicine 9:956811). 209 studies were assessed for compliance with the Checklist for AI in Medical Imaging (CLAIM), a framework for reporting. We found variable-and sometimes poor-quality of reporting and identified significant and frequently missing information in publications. Compliance with CLAIM was high for descriptions of models (100%, IQR 80%-100%), but lower than expected for descriptions of study design (71%, IQR 63-86%), datasets used in training and testing (63%, IQR 50%-67%) and model performance (60%, IQR 50%-70%). Here, we present a summary of our key findings, aimed at general readers who may not be experts in AI, and use them as a framework to discuss the factors determining quality of reporting, making recommendations for improving the reporting of research in this field. We aim to assist researchers in presenting their work and readers in their appraisal of evidence. Finally, we emphasise the need for close scrutiny of studies presenting AI tools, even in the face of the excitement surrounding AI in cardiac imaging.

Evaluation of Spin in the Clinical Literature of Suture Tape Augmentation for Ankle Instability.

Background: Spin is defined as the use of specific reporting strategies to highlight the beneficial effect of a treatment despite nonsignificant results. The presence of spin in peer-reviewed literature can negatively impact clinical and research practices. The purpose of this study was to identify the quantity and types of spin present in primary studies and systematic reviews using suture tape augmentation for ankle instability as a model. Methods: This study was conducted per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Each abstract was assessed for the presence of the 15 most common types of spin. Extracted data included study title, authors, publication year, journal, level of evidence, study design, funding, reported adherence to PRISMA guidelines, and PROSPERO registration. Full texts of systematic reviews were used in the assessment of study quality per A Measurement Tool to Assess Systematic Reviews Version 2 (AMSTAR 2). Results: Nineteen studies were included in the final sample. At least 1 type of spin was identified in each study except one (18 of 19, 94.7%). The most common type of spin observed was type 3 ("selective reporting or overemphasis on efficacy outcomes or analysis favoring the beneficial effect of the experimental intervention") (6 of 19, 31.6%), The second most reported category of spin was type 4 ("the conclusion claims safety based on non-statistically significant results with a wide confidence interval") (4 of 19, 21.1%). Among systematic reviews, we identified type 5 ("the conclusion claims the beneficial effect of the experimental treatment despite a high risk of bias in primary studies") in 4 out of 6 (66.7%) of the articles that were included. No significant associations were found between study characteristics and type of spin. Conclusion: In this exploration of the introduction of a new technology, we identified spin to be highly present in the abstracts of primary studies and systematic reviews concerning suture tape augmentation for ankle instability. Steps should be taken by scientific journals to ensure that spin is minimized in the abstract to accurately reflect the quality of the intervention.

Reporting of harms in clinical trials of esketamine in depression: a systematic review.

While previous systematic reviews of trials evaluating conventional antidepressants highlighted inadequacies and inconsistencies in adverse event (AE) reporting, no evaluation is available on esketamine in resistant depression. The objective of this review was to assess quality of reporting AEs in all published clinical trials studying esketamine. It also aimed to compare the proportions of AEs reported in journal articles to those recorded in the ClinicalTrial.gov Registers. Clinical trials evaluating the efficacy and safety of esketamine in depression were searched using Medline and ClinicalTrials.gov. The quality of reporting harms was assessed using a 21-item checklist from the CONSORT Extension of Harms (1 point by item). The total quality score was graded into four categories: high (17-21), moderate (12-16), low (7-11) and very low (0-6). Ten clinical trials were included in the analysis. Nine trials were classified as 'low quality' with regard to safety, one trial was classified as 'moderate quality'. Compared to AEs recorded in ClinicalTrials.gov, we found that 41.5% of serious AEs and 39% of non-serious AEs were not reported in the published articles. Among them, the majority were psychiatric events but also cardiovascular events and 94% concerned patients from esketamine groups. Quality of AEs reporting in published clinical trials of esketamine was poor and harms were reported less frequently in journal publications than in ClinicalTrial.gov Registers. The study suggests that an assessment of the benefits/risks balance of esketamine based on the results reported in trial publications is flawed due to the poor accuracy and completeness of harm data.

Patient-reported outcomes in refractory hormone-producing pituitary adenomas: an unmet need.

PURPOSE: To describe quality and outcomes of patient-reported outcome (PRO) measures (PROMs) used in patients with refractory hormone-producing pituitary adenomas, and to provide an overview of PROs in these challenging pituitary adenomas. METHODS: Three databases were searched for studies reporting on refractory pituitary adenomas. For the purpose of this review, refractory adenomas were defined as tumors resistant to primary therapy. General risk of bias was assessed using a component approach and the quality of PROM reporting was assessed using the International Society for Quality of Life Research (ISOQOL) criteria. RESULTS: 20 studies reported on PROMs in refractory pituitary adenomas, using 14 different PROMs, of which 4 were disease specific (median general risk of bias score: 33.5% (range 6-50%) and ISOQOL score: 46% (range 29-62%)). SF-36/RAND-36 and AcroQoL were most frequently used. Health-related quality of life in refractory patients (measured by AcroQoL, SF-36/Rand-36, Tuebingen CD-25, and EQ-5D-5L) varied greatly across studies, and was not always impaired compared to patients in remission. CONCLUSION: There is a scarcity of data on PROs in the subset of pituitary adenomas that is more difficult to treat, e.g., refractory and these patients are difficult to isolate from the total cohort. The patients' perspective on quality of life, therefore, remains largely unknown in refractory patients. Thus, PROs in refractory pituitary adenomas require adequate analysis using properly reported disease specific PROMs in large cohorts to enable appropriate interpretation for use in clinical practice.

Over-interpretation of findings in diagnostic accuracy studies of infectious diseases.

OBJECTIVES: To assess the prevalence of overly positive interpretation, also called 'spin',-of results in diagnostic accuracy studies of infectious diseases and to identify suggestions for improvement. METHODS: A PubMed search was performed to identify diagnostic accuracy studies of infectious diseases published between January and March 2019. Each article was assessed by two authors independently to identify study characteristics and forms of actual and potential over-interpretation. 'Actual over-interpretation' was defined as conclusions that were not on the basis of study aims or conclusions that were more favourable than justified by the study findings. There are other practices that may result in the over-interpretation of study findings and these have been described as 'potential over-interpretation'. RESULTS: The final analysis included 120 studies. Favourable or promising recommendations were made in the main text of 101 (84%) of the included studies. Evidence of actual over-interpretation (spin) was found in 30 (25%) articles, with 22 (18%) studies reporting a conclusion that did not match the study aims and 56 (47%) studies with a more positive conclusion in the abstract than the main text. All analysed studies exhibited at least one form of potential over-interpretation, with was most commonly a lack of sample size calculation (n = 109, 91%) and not reporting a null hypothesis (n = 115, 96%). DISCUSSION: Evidence of over-interpretation of results was found in one-third of the included studies. We have proposed possible interventions to prevent overly positive interpretations of results in diagnostic accuracy studies.

Reporting and risk of bias of prediction models based on machine learning methods in preterm birth: A systematic review.

INTRODUCTION: There was limited evidence on the quality of reporting and methodological quality of prediction models using machine learning methods in preterm birth. This systematic review aimed to assess the reporting quality and risk of bias of a machine learning-based prediction model in preterm birth. MATERIAL AND METHODS: We conducted a systematic review, searching the PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, China Biology Medicine disk, VIP Database, and WanFang Data from inception to September 27, 2021. Studies that developed (validated) a prediction model using machine learning methods in preterm birth were included. We used the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement and Prediction model Risk of Bias Assessment Tool (PROBAST) to evaluate the reporting quality and the risk of bias of included studies, respectively. Findings were summarized using descriptive statistics and visual plots. The protocol was registered in PROSPERO (no. CRD 42022301623). RESULTS: Twenty-nine studies met the inclusion criteria, with 24 development-only studies and 5 development-with-validation studies. Overall, TRIPOD adherence per study ranged from 17% to 79%, with a median adherence of 49%. The reporting of title, abstract, blinding of predictors, sample size justification, explanation of model, and model performance were mostly poor, with TRIPOD adherence ranging from 4% to 17%. For all included studies, 79% had a high overall risk of bias, and 21% had an unclear overall risk of bias. The analysis domain was most commonly rated as high risk of bias in included studies, mainly as a result of small effective sample size, selection of predictors based on univariable analysis, and lack of calibration evaluation. CONCLUSIONS: Reporting and methodological quality of machine learning-based prediction models in preterm birth were poor. It is urgent to improve the design, conduct, and reporting of such studies to boost the application of machine learning-based prediction models in preterm birth in clinical practice.

What is the quality of reporting in randomized controlled trials in spinal conditions.

Purpose: Substandard quality across published randomized controlled trials (RCTs) is a major concern. Imperfect reporting has the potential to distort the evidence landscape and waste valuable health-care resources. In this study, we aim to assess the current quality of reporting in the field of spine using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist. Materials and Methods: A list of published RCTs in the field of spine disease from January 1, 2013, to December 31, 2020, was built. Two reviewers scored the published RCTs against a modified CONSORT checklist. The mean adjusted CONSORT scores for each study, reporting category, and checklist item were calculated. Results: The mean and median scores across all of the RCTs were 0.72 and 0.74 out of 1.00, respectively. The spectrum of scores was wide, ranging from 0.45 to 0.94. The reporting categories with the lowest score included randomization, blinding, and abstract. The items which were most under-reported included allocation sequence generation, type of randomization used, full trial protocol details, and abstract methodology. The inter-rater reliability between our reviewers was substantial (κ = 0.7, κ = 0.71). Conclusion: Our findings correlate with only a moderate level of compliance to the CONSORT criteria on the quality of reporting for RCTs in spinal conditions. This is in line with previous reports on compliance, both within and outside the field of spinal conditions. Further continued and sustained efforts are still required to enhance the quality and consistency of RCT reporting, ultimately reducing health-care resource wastage and improving patient safety.

Transparency and reporting characteristics of COVID-19 randomized controlled trials.

BACKGROUND: In the context of the COVID-19 pandemic, randomized controlled trials (RCTs) are essential to support clinical decision-making. We aimed (1) to assess and compare the reporting characteristics of RCTs between preprints and peer-reviewed publications and (2) to assess whether reporting improves after the peer review process for all preprints subsequently published in peer-reviewed journals. METHODS: We searched the Cochrane COVID-19 Study Register and L·OVE COVID-19 platform to identify all reports of RCTs assessing pharmacological treatments of COVID-19, up to May 2021. We extracted indicators of transparency (e.g., trial registration, data sharing intentions) and assessed the completeness of reporting (i.e., some important CONSORT items, conflict of interest, ethical approval) using a standardized data extraction form. We also identified paired reports published in preprint and peer-reviewed publications. RESULTS: We identified 251 trial reports: 121 (48%) were first published in peer-reviewed journals, and 130 (52%) were first published as preprints. Transparency was poor. About half of trials were prospectively registered (n = 140, 56%); 38% (n = 95) made their full protocols available, and 29% (n = 72) provided access to their statistical analysis plan report. A data sharing statement was reported in 68% (n = 170) of the reports of which 91% stated their willingness to share. Completeness of reporting was low: only 32% (n = 81) of trials completely defined the pre-specified primary outcome measures; 57% (n = 143) reported the process of allocation concealment. Overall, 51% (n = 127) adequately reported the results for the primary outcomes while only 14% (n = 36) of trials adequately described harms. Primary outcome(s) reported in trial registries and published reports were inconsistent in 49% (n = 104) of trials; of them, only 15% (n = 16) disclosed outcome switching in the report. There were no major differences between preprints and peer-reviewed publications. Of the 130 RCTs published as preprints, 78 were subsequently published in a peer-reviewed journal. There was no major improvement after the journal peer review process for most items. CONCLUSIONS: Transparency, completeness, and consistency of reporting of COVID-19 clinical trials were insufficient both in preprints and peer-reviewed publications. A comparison of paired reports published in preprint and peer-reviewed publication did not indicate major improvement.

Completeness of reporting and outcome switching in trials published in Indian journals from 2017 to 2019: A cross-sectional study.

Context: Randomized controlled trials (RCTs) are among the cornerstones for generation of high-quality clinical evidence. However, incomplete or biased reporting of trials can hamper the process of review of trials and their results. Outcome switching, intentional, or otherwise leads to biased reporting and can result in false inferences. Aims: The aim of this study was to analyze the completeness of reporting Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and detect if outcome switching had occurred. Settings and Design: This cross-sectional study was conducted in the department of pharmacology. Methods: Online editions of journals published by the Indian association of medical specialties from 2017 to 2019 were accessed, and the full-text versions of the published RCTs in them were downloaded. Reporting of each item in the CONSORT checklist was recorded. The effect of trial registration and CONSORT endorsement on reporting of key methodological parameters was also determined. Protocols of registered trials were accessed, and the outcome switching was assessed. Statistical Analysis Used: Descriptive statistics were used to summarize the data. Results: Average completeness of reporting has significantly improved from 2017 to 2019. Major areas of underreporting were generalizability, protocol availability, trial registration, date of recruitment, allocation concealment, and the patient flow diagram. CONSORT endorsing journals had worse, whereas registered trials had better reporting of key methodological indicators. No overt switching of outcomes was observed in 84 out of 86 registered trials where trial protocols were available online for comparison. Conclusions: Quality of clinical trial reporting in the Indian medical journals has improved but remains inadequate. CONSORT nonendorsement prevents completeness of trial reporting.

Prediction models for living organ transplantation are poorly developed, reported, and validated: a systematic review.

OBJECTIVE: To identify and critically appraise risk prediction models for living donor solid organ transplant counselling. STUDY DESIGN AND SETTING: We systematically reviewed articles describing the development or validation of prognostic risk prediction models about living donor solid organ (kidney and liver) transplantation indexed in Medline until April 4, 2021. Models were eligible if intended to predict, at transplant counselling, any outcome occurring after transplantation or donation in recipients or donors. Duplicate study selection, data extraction, assessment for risk of bias and quality of reporting was done using the CHARMS checklist, PRISMA recommendations, PROBAST tool, and TRIPOD Statement. RESULTS: We screened 4691 titles and included 49 studies describing 68 models (35 kidney, 33 liver transplantation). We identified 49 new risk prediction models and 19 external validations of existing models. Most models predicted recipients outcomes (n = 38, 75%), e.g., kidney graft loss (29%), or mortality of liver transplant recipients (55%). Many new models (n = 46, 94%) and external validations (n = 17, 89%) had a high risk of bias because of methodological weaknesses. The quality of reporting was generally poor. CONCLUSION: We advise against applying poorly developed, reported, or validated prediction models. Future studies could validate or update the few identified methodologically appropriate models.

The critical appraisal of randomized controlled trials published in an Indian journal to assess the quality of reporting: A retrospective, cross-sectional study.

BACKGROUND: Although randomized controlled trials (RCTs) are the highest levels of evidence, they might not necessarily be of good quality. Hence, RCTs should always be appraised critically. Critical appraisal is the corroboration of evidence by methodically studying its validity, reliability, and applicability. OBJECTIVE: The primary objective of this study was to do a critical appraisal of the RCTs published in Indian Journal of Pharmacology (IJP) from 2011 to 2016. The secondary objective was to scrutinize how adequately the published RCTs adhere to the Consolidated Standards of Reporting Trials (CONSORT) declaration. MATERIALS AND METHODS: The present study included all RCTs published as full-text articles in IJP from January 2011 to December 2016. The identified RCTs were critically appraised using the critical appraisal checklist based on CONSORT 2010 guidelines and its extensions. RESULTS: According to this analysis, 75% (95% confidence interval [CI]: 0.56-0.87) of the articles had given details about the sample size calculation. Nearly 89.29% (95% CI: 0.72-0.96) of the articles described the method for generating random allocation sequence, but only 35.71% (95% CI: 0.20-0.54) of the articles described allocation concealment method. Almost 35.71% (95% CI: 0.20-0.54) of the trials reported results as per the principle of the intention to treat (ITT). Nearly 21.43% (95% CI: 0.10-0.39) of the studies reported CIs in the present study. CONCLUSION: Allocation concealment method, analysis of the data based on the ITT principle, and reporting CIs were found to be underreported in this study. There should be more emphasis on reporting of allocation concealment, ITT analysis, and CI.

A retrospective cross-sectional descriptive study to critically appraise the quality of reporting of health economic evaluations conducted in the Indian setting.

BACKGROUND: The reporting quality of economic research could benefit from enhanced quality assurance procedures. At present, there are small numbers of health economic researches being conducted with Indian context or setting. There is not much clarity about the reporting quality of health economic researches being conducted with Indian context or setting. OBJECTIVE: The primary objective is to of this study was to appraise the quality of reporting of health economic evaluations conducted in the Indian setting and published between January 2014 and December 2018. MATERIALS AND METHODS: This was a retrospective, cross-sectional, descriptive analysis. The MEDLINE in PubMed, Google Scholar, and Science Direct were systematically searched to search for economic evaluations. The consolidated health economic evaluation reporting standards statement checklist was utilized to assess the quality of reporting of the included studies. For grading the quality of the included health economic assessments, the Quality of Health Evaluation Studies (QHES) instrument was used. RESULTS: Thirty studies fulfilled the inclusion criteria and were included in the study. The mean QHES score was 80.26 (standard deviation = 8.06). Twenty-five (83.33%, 95% confidence interval [CI]: 0.66-0.92) of the article mentioned perspective of the study. Twenty-nine (96.66%, 95% CI: 0.83-0.99) of the article described the effects of uncertainty for all input parameters. Twenty (66.66%, 95% CI: 0.48-0.80) of the article reported all funding sources. CONCLUSIONS: Overall, the quality of reporting of the included health economic studies was good, which reemphasizes their usefulness in supporting the decision-making procedure about better medicine. The finding of this study will be a small step toward ensuring robust and high-quality health economics data in India.