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Complete and transparent reporting of randomized controlled trial publications (RCTs) is essential for assessing their credibility. We aimed to develop text classification models for determining whether RCT publications report CONSORT checklist items. Using a corpus annotated with 37 fine-grained CONSORT items, we trained sentence classification models (PubMedBERT fine-tuning, BioGPT fine-tuning, and in-context learning with GPT-4) and compared their performance. We assessed the impact of data augmentation methods (Easy Data Augmentation (EDA), UMLS-EDA, text generation and rephrasing with GPT-4) on model performance. We also fine-tuned section-specific PubMedBERT models (e.g., Methods) to evaluate whether they could improve performance compared to the single full model. We performed 5-fold cross-validation and report precision, recall, F1 score, and area under curve (AUC). Fine-tuned PubMedBERT model that uses the sentence along with the surrounding sentences and section headers yielded the best overall performance (sentence level: 0.71 micro-F1, 0.67 macro-F1; article-level: 0.90 micro-F1, 0.84 macro-F1). Data augmentation had limited positive effect. BioGPT fine-tuning and GPT-4 in-context learning exhibited suboptimal results. Methods-specific model improved recognition of methodology items, other section-specific models did not have significant impact. Most CONSORT checklist items can be recognized reasonably well with the fine-tuned PubMedBERT model but there is room for improvement. Improved models can underpin the journal editorial workflows and CONSORT adherence checks.

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Background: It is of vital importance to comprehensively and transparently report clinical trial activity. The SPIRIT 2013 and CONSORT 2010 statements exist to define items to be reported in clinical trial protocols and randomized controlled trials, respectively. The aim of this methodological review was to assess the reporting quality of pediatric neuro-oncology trial protocols and trial result articles. Methods: Published trial protocols and phase II/III trial result articles relating to pediatric brain tumors (published after the introduction of the SPIRIT 2013 statement), were identified through searches of 4 electronic bibliographic databases. The reporting quality of included trial protocols and result articles was assessed against the aforementioned statements. In addition, the CONSORT-A checklist was used to assess the abstracts of trial result articles. Percentage adherence was calculated for each article. Results: Nine trial protocols, 68 phase II trials, and 8 phase III trial result articles were included. Mean adherence of trial protocols to the SPIRIT statement was 76.8% (SD: 0.09). Mean adherence of trial abstracts to CONSORT-A was 67.4% (SD: 0.13) for phase II abstracts and 47.5% (SD: 0.09) for phase III abstracts. Adherence of trial result articles to CONSORT was 71.3% (SD: 0.10) for phase II trials and 70.3% (SD: 0.13) for phase III trials. Conclusions: The reporting quality of pediatric neuro-oncology trial protocols and trial result articles requires improvement, particularly in the areas of randomization and blinding. This is consistent with our previously published findings following similar assessment of reporting quality for adult neuro-oncology trial protocols and result articles.

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With the successive release of the CONSORT extensions for acupuncture, moxibustion, cupping, and Tuina/massage, this review aims to assess the reporting characteristics and quality of randomized controlled trials (RCTs) based on these specific guidelines. A comprehensive review was conducted by searching multiple databases, including Embase, Ovid MEDLINE(R), All EBM Reviews, AMED, CNKI, VIP Chinese Medical Journal Database, and Wanfang Data, for publications from January 1 to December 31, 2022. Two reviewers independently evaluated the eligibility of the records, extracted predetermined information, and assessed the reporting based on the STRICTA, STRICTOM, STRICTOC, and STRICTOTM checklists. Among the included 387 studies (acupuncture, 213; Tuina/massage, 85; moxibustion, 73; cupping, 16), the overall reporting compliance averaged 56.0%, with acupuncture leading at 62.6%, followed by cupping (60.2%), moxibustion (53.1%), and Tuina/massage (47.9%). About half of the evaluated items showed poor reporting (compliance rate < 65%). Notably, international journals demonstrated significantly higher reporting quality than Chinese journals (P < 0.05). Although acupuncture trials had relatively higher compliance rates, deficiencies persist in reporting non-pharmacological therapies of Chinese medicine, particularly in areas like treatment environment details and provider background information.

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BACKGROUND: The American Academy of Orthopaedic Surgeons (AAOS) has developed a clinical practice guideline (CPG) for management of anterior cruciate ligament (ACL) injuries. Primary studies such as randomized controlled trials (RCTs) are cited as evidence for the guidelines. Given the influence that these trials have on patient care, adherence to standardized protocols for conducting and reporting RCTs is essential. PURPOSE: To evaluate the CONSORT (Consolidated Standards of Reporting Trials) Extension for Harms-related reporting of RCTs cited as supporting evidence for the AAOS CPG on the management of ACL tears. STUDY DESIGN: Cross-sectional study. METHODS: The reference section of the AAOS guideline for ACL tears was first screened for RCTs cited in the CPG. Next, each RCT was evaluated for adherence to the CONSORT Extension for Harms checklist. Both identification of RCTs and assessment of adherence were performed in a masked and duplicate process. Descriptive statistics were used to summarize adherence to CONSORT Extension for Harms items. A Pearson correlation test was conducted to assess the relationship between the year of publication and adherence to CONSORT harms reporting. RESULTS: The sample included 113 RCTs, of which 16 (14.2%) were published before the CONSORT Extension for Harms was implemented in 2004. Sample sizes ranged from 24 to 4564 participants, with a mean of 228. None of the included RCTs included all 18 items in the CONSORT Extension for Harms checklist. The mean number of checklist items reported was 4 (of 18; 22.2%). A moderate, positive, and statistically significant correlation was found between the RCT publication year and the adherence with reporting of the CONSORT Extension for Harms (t111 = 3.54; P < .001) (r = 0.32; 95% CI, 0.14-0.47). CONCLUSION: Harms were infrequently reported in RCTs cited as supporting evidence in the AAOS CPG for the management of ACL tears. One encouraging finding was the positive correlation between the year when RCTs were published and how well they adhered to reporting harms. Efforts to improve adverse event reporting are warranted, as RCTs are commonly used to make clinical decisions in orthopaedic surgery.

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INTRODUCTION: Moxibustion is clinically used for treating various chronic diseases; however, the reporting quality of current published RCTs of moxibustion is unclear. The objective of this study was to assess the reporting quality of RCTs focusing on moxibustion as a treatment for chronic diseases. METHODS: Seven databases were searched to identify relevant RCTs. Criteria for evaluating the reporting quality of standard RCT elements and moxibustion intervention-related information were developed based on the CONSORT statement and its STRICTOM extension, respectively. Multivariate regression models were used to investigate factors impacting reporting quality. RESULTS: A total of 310 RCTs were included, with 41 (7.6%) published in English journals and 269 (92.4%) in Chinese journals. The median CONSORT and STRICTOM scores of these RCTs, with a maximum score of 100, were 41.2 and 62.9, respectively. RCTs with a later publication year and protocol registration or ethical approval exhibited significantly higher CONSORT and STRICTOM scores. Higher CONSORT scores were also significantly associated with English language publication, funding support, and inclusion of a safety evaluation, while higher STRICTOM scores were additionally associated with an active control design. CONCLUSION: The reporting quality of RCTs focusing on moxibustion treatment for chronic diseases is subpar, with gradual but limited improvement over the last 25 years. To enhance the reporting quality of moxibustion RCTs, researchers should develop a comprehensive study protocol and standardize result reporting based on CONSORT and STRICTOM statements. Registration platforms, ethical approval organizations, funders, and journals can also contribute to this improvement by bolstering structured information reporting in the review process.

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OBJECTIVE: To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for depression. METHODS: Systematic searches were performed in PubMed, the Cochrane Library, EMbase, CNKI, Wanfang, SinoMed and VIP Database for RCTs of acupuncture in treatment of depression. The search time was from the establishment of database to December 1, 2023, and the language restriction was Chinese and English. The reporting quality of RCTs of acupuncture for depression was evaluated using the CONSORT statement, the international standardization for trial reporting, STRICTA, the international standard for clinical trial interventions of acupuncture, and SHARE, the guideline and checklist for reporting sham acupuncture controls. RESULTS: According to the CONSORT statement items, the items with the reporting rate less than 50% was accounted for 54.05% of all of the items for Chinese articles, and there were 8 and 1 items with a reporting rate of 0% and 100%, respectively. For the English articles, the items with the reporting rate less than 50% was accounted for 35.14% of all of the items, and there were 3 and 7 items with a reporting rate of 0% and 100%, respectively. The reporting rate of 15 items in Chinese and English articles was greater than 50%, e.g. structured abstract, background and purpose. Based on STRICTA criteria, the reporting rate of either Chinese or English articles was relatively high. The items for Chinese articles with the reporting rate less than 50% was accounted for 23.53% of all of the items, and there were 1 and 4 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 11.76% of all of the items, and there was 1 item with a reporting rate of either 0% or 100%. In compliance with SHARE checklist, the reporting rate was low for either Chinese or English articles. The items with the reporting rate less than 50% was accounted for 57.89% of all of the items for Chinese articles, and there were 2 and 0 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 52.63% of all of the items, and there was 1 item with a reporting rate of 0% and 100%, respectively. CONCLUSION: The overall reporting quality of RCTs of acupuncture for depression is low currently. It is urgent to enhance the reporting of the details on sham acupuncture control especially. It is suggested that RCTs should be reported strictly in compliance with the CONSORT statement, STRICTA criteria, and SHARE checklist in the future.

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PURPOSE: In the context of ophthalmologic practice, there has been a rapid increase in the amount of data collected using electronic health records (EHR). Artificial intelligence (AI) offers a promising means of centralizing data collection and analysis, but to date, most AI algorithms have only been applied to analyzing image data in ophthalmologic practice. In this review we aimed to characterize the use of AI in the analysis of EHR, and to critically appraise the adherence of each included study to the CONSORT-AI reporting guideline. METHODS: A comprehensive search of three relevant databases (MEDLINE, EMBASE, and Cochrane Library) from January 2010 to February 2023 was conducted. The included studies were evaluated for reporting quality based on the AI-specific items from the CONSORT-AI reporting guideline. RESULTS: Of the 4,968 articles identified by our search, 89 studies met all inclusion criteria and were included in this review. Most of the studies utilized AI for ocular disease prediction (n = 41, 46.1%), and diabetic retinopathy was the most studied ocular pathology (n = 19, 21.3%). The overall mean CONSORT-AI score across the 14 measured items was 12.1 (range 8-14, median 12). Categories with the lowest adherence rates were: describing handling of poor quality data (48.3%), specifying participant inclusion and exclusion criteria (56.2%), and detailing access to the AI intervention or its code, including any restrictions (62.9%). CONCLUSIONS: In conclusion, we have identified that AI is prominently being used for disease prediction in ophthalmology clinics, however these algorithms are limited by their lack of generalizability and cross-center reproducibility. A standardized framework for AI reporting should be developed, to improve AI applications in the management of ocular disease and ophthalmology decision making.

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BACKGROUND: Recently, trials have supported changes in deep caries management. However, reporting might lack details, affecting interpretation and implementation. Thus, we aimed to evaluate the adherence to the CONSORT statement and the risk of bias of randomized controlled trials (RCTs) on deep caries management published in pediatric dental journals. METHODS: We searched PubMed for RCTs in six pediatric dental journals between 2010 and 2022, focusing on deep caries lesion management. Adherence to the CONSORT guideline and the risk of bias were assessed using a modified tool with 19 items; each scored from 0 to 2 (maximum of 38 points), and the Cochrane risk-of-bias (RoB 2) tool. We performed descriptive and regression analyses (α = 5%). RESULTS: We analyzed 127 RCTs. The mean (standard deviation) CONSORT adherence score was 21.1 (6.7). Notably, 96.1% of the studies received a score of 2 for the "intervention" item, whereas 83.5% scored 0 for the "estimated effect size". The risk of bias assessment revealed that 40.2% of the RCTs were at high risk, 59% were at low risk, and 0.8% were at low risk. RCTs with a high risk of bias had lower CONSORT scores (p<0.001) than those with low or some concerns. RCTs published in journals without the endorsement of the CONSORT statement had lower scores than those in journals with the endorsement of the CONSORT statement. Older RCTs (6-10 years old and more than 10 years old) showed significantly lower CONSORT statement compliance than trials published recently within 5 years. CONCLUSION: Adherence to the CONSORT was relatively low among the investigated RCTs. Moreover, lower adherence to the CONSORT was associated with a higher risk of bias. TRIAL REGISTRATION: This study protocol was prospectively registered on the Open Science Framework - DOI ( 10.17605/OSF.IO/V6SYZ ).

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OBJECTIVES: Incomplete reporting of safety outcomes in quality and availability of safety reporting in published articles of randomized controlled trials (RCTs) were described in different medical areas. The number of RCTs assessing systemic treatments for psoriasis has increased considerably. Complete and precise reporting of safety is mandatory for the efficacy/harms balance evaluation. We aimed to assess the quality and availability of safety reporting in published RCTs assessing systemic treatments for psoriasis, as well as the concordance of data between published trials and ClinicalTrials.gov (CT). STUDY DESIGN AND SETTING: We included all RCTs in adults initiated after September 2009, assessing systemic psoriasis treatments compared with placebo or with an active comparator. All trials were selected in duplicate by 2 independent authors from the latest search of the dedicated Cochrane review. We described quality of safety reporting for all published RCTs, using a modified Consolidated Standards of Reporting Trials harms scale by using descriptive analysis, and a composite score of 3 key items of safety report. For each RCT, data on adverse events (AEs)/serious AEs (SAEs) were extracted from the publication and CT: total number of AEs/SAEs, patients with AEs/SAEs, SAEs by system organ class classification and deaths. These data were compared between sources for each RCT. RESULTS: In total, 128 trials were included in the analysis of reporting quality, and 76 in the analysis of data concordance between sources. The median number of reported Consolidated Standards of Reporting Trials harms items per article was 9 out of 18 (IQR 7-10), and mean number was 8.39 (SD = 3.02). Items in the methods section were the least frequently reported. The proportion of RCTs reporting the number of SAEs and death were significantly higher on CT than in the published article ((100% (76/76) vs 88.2%, McNemar test, P < .0016). At least 1 discrepancy between sources for SAE safety data was found in 30/76 (39.5%) RCTs. CONCLUSION: Shortcomings and gaps in the quality of safety reporting in publications of RCTs of systemic psoriasis treatments have been identified. A lack of data in published articles and discrepancies between published articles and CT data complete this finding.

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Aims/Background Blended learning has been a commonly adopted teaching mode in the medical education community in recent years. Many studies have shown that the blended learning mode is superior to the traditional teaching mode. Nonetheless, pinpointing the specific advantages provided by blended teaching methods is challenging, since multiple elements influence their effectiveness. This study aimed to investigate the reliability of the conclusions of published randomised controlled trials (RCTs) on blended learning in medical education by assessing their quality, and to provide suggestions for future related studies. Methods Two investigators searched PUBMED and EMBASE, and assessed RCTs related to medical blended learning published from January 1, 2010 to December 31, 2021. The analysis of the overall quality of each report was based on the 2010 consolidated standard of reporting trials (CONSORT) Statement applying a 28-point overall quality score. We also conducted a multivariate assessment including year of publication, region of the trial, journal, impact factor, sample size, and the primary outcome. Results A total of 22 RCTs closely relevant to medical blended learning were eventually selected for study. The results demonstrated that half of the studies failed to explicitly describe at least 34% of the items in the 2010 CONSORT Statement. Medical blended learning is an emerging new teaching mode, with 95.45% of RCTs published since 2010. However, many issues that we consider crucial were not satisfactorily addressed in the selected RCTs. Conclusion Although the 2010 CONSORT Statement was published more than a decade ago, the quality of RCTs remains unsatisfactory. Some important items were inadequately reported in many RCTs such as sample size, blinding, and concealment. We encourage researchers who focus on the effects of blended learning in medical education to incorporate the guidelines in the 2010 CONSORT Statement when designing and conducting relevant research. Researchers, reviewers, and editors also need to work together to improve the quality of relevant RCTs in accordance with the requirements of the 2010 CONSORT Statement.

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OBJECTIVE: This study aimed to assess the completeness of adverse event (AE) reporting in randomized control trials (RCTs) focused on rhinoplasty, using the Consolidated Standards for Reporting (CONSORT) Extension for Harms checklist. STUDY DESIGN: A cross-sectional design was employed to review RCTs related to rhinoplasty published between January 1, 2005, and January 28, 2022. SETTING: The study analyzed clinical trials on rhinoplasty retrieved from PubMed. METHODS: We performed a comprehension search on PubMed, blind and duplicate screening, and data extraction. Adherence to the 18 recommendations of the CONSORT Extension for Harms was evaluated, with 1 point assigned for each adhered item. Percent adherence was calculated based on the 18 points, taking into account the multiple subcategories within some recommendations. Descriptive statistics were used to summarize adherence-including frequencies, percentages, and 95% confidence intervals. RESULTS: Our search returned 240 articles, of which 56 met inclusion criteria. No RCTs adhered to all 18 CONSORT Extension for Harms items. Twenty-six (26/56, 46.4%) adhered to ≥50% of the items, and 30 (30/56, 53.6%) adhered to ≥33.3% of the items. Seven (7/56, 12.5%) RCTs adhered to no items. Across all RCTs, the average number of CONSORT-Harms items adhered to was 7.2 (7.2/18, 40.0%). The most adhered to item was item 10. Discussion balanced with regard to efficacy and AEs (80.4%, [70.0-90.8]). CONCLUSION: This study highlights the inadequacy of AE reporting in rhinoplasty RCTs according to CONSORT-Harms guidelines. Urgent efforts are required to bridge this reporting gap and enhance transparency in surgical research, ultimately safeguarding patient well-being.

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AIM: Heart failure (HF) is a major cause of morbidity and mortality in older adults. Randomized controlled trials (RCTs) inform HF policy and practice, but the accurate interpretation of results is contingent on clear and transparent reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement serves as a guide to RCT reporting. We evaluated the quality of reporting in HF RCTs in high-impact journals by assessing their adherence to CONSORT. METHODS AND RESULTS: We searched MEDLINE, EMBASE and CINAHL for HF RCTs published in high-impact journals 2000-2020. We assessed the proportion of CONSORT criteria that individual HF RCTs adhered to, and used the Jonckheere-Terpstra test to examine temporal trends in adherence. Multivariable linear regression explored the association between trial characteristics and adherence to CONSORT. Primary analysis assessed adherence to CONSORT 2010 update. A sensitivity analysis assessed adherence to the original (1996) CONSORT criteria. Among 221 RCTs analysed, the mean (standard deviation [SD]) adherence was suboptimal overall (mean [SD] adherence 69.7 [11.5]%) (5513/7913 criteria), with a temporal increase in adherence over the 20-year period (p < 0.001). Factors associated with adherence included publication after versus during/before 2010 (ß = 10.17, 95% confidence interval [CI] 7.64-12.70; p < 0.001); two-group parallel individual-level randomization versus other (including multi-group or cluster randomization) (ß = 5.81, 95% CI 2.88-8.73; p < 0.001); and multicentre versus single-centre trials (ß = 7.26, 95% CI 3.25-11.27; p < 0.001). There was no difference in trial adherence to the updated CONSORT (2010) versus the original (1996) CONSORT criteria, and temporal trends in adherence to both sets of criteria were similar, likely due to overlap between the two sets of criteria. Trials with greater adherence to CONSORT were published in higher impact factor journals, with a positive correlation (r = 0.312; p < 0.001). CONCLUSION: The quality of reporting in HF RCTs, as measured by CONSORT adherence, has improved over time but remains suboptimal.

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Objective: To develop text classification models for determining whether the checklist items in the CONSORT reporting guidelines are reported in randomized controlled trial publications. Materials and Methods: Using a corpus annotated at the sentence level with 37 fine-grained CONSORT items, we trained several sentence classification models (PubMedBERT fine-tuning, BioGPT fine-tuning, and in-context learning with GPT-4) and compared their performance. To address the problem of small training dataset, we used several data augmentation methods (EDA, UMLS-EDA, text generation and rephrasing with GPT-4) and assessed their impact on the fine-tuned PubMedBERT model. We also fine-tuned PubMedBERT models limited to checklist items associated with specific sections (e.g., Methods) to evaluate whether such models could improve performance compared to the single full model. We performed 5-fold cross-validation and report precision, recall, F1 score, and area under curve (AUC). Results: Fine-tuned PubMedBERT model that takes as input the sentence and the surrounding sentence representations and uses section headers yielded the best overall performance (0.71 micro-F1, 0.64 macro-F1). Data augmentation had limited positive effect, UMLS-EDA yielding slightly better results than data augmentation using GPT-4. BioGPT fine-tuning and GPT-4 in-context learning exhibited suboptimal results. Methods-specific model yielded higher performance for methodology items, other section-specific models did not have significant impact. Conclusion: Most CONSORT checklist items can be recognized reasonably well with the fine-tuned PubMedBERT model but there is room for improvement. Improved models can underpin the journal editorial workflows and CONSORT adherence checks and can help authors in improving the reporting quality and completeness of their manuscripts.

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This chapter provides a succinct overview of several recommendations for the design and analysis of treatments for AUD with a specific focus on increasing rigor and generalizability of treatment studies in order to increase the reach of AUD treatment. We recommend that researchers always register their trials in a clinical trial registry and make the protocol accessible so that the trial can be replicated in future work, follow CONSORT reporting guidelines when reporting the results of the trial, carefully describe all inclusion and exclusion criteria as well as the randomization scheme, and always use an intent to treat design with attention to analysis of missing data. In addition, we recommend that researchers pay closer attention to recruitment and engagement strategies that increase enrollment and retention of historically marginalized and understudied populations, and we end with a plea for more consideration of implementation science approaches to increase the dissemination and implementation of AUD treatment in real-world settings.

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Background: The CONSORT Extension for Chinese Herbal Medicine Formula 2017 (CONSORT-CHM Formula 2017) has established a reporting standard for randomized controlled trials (RCTs) of Chinese Herbal Medicine Formula (CHMF) interventions; however, its adherence and implications for the design and execution of study design remain ambiguous. It is necessary to evaluate the level of compliance with the CONSORT-CHM Formula 2017 in RCTs conducted over the past 5 years, and to determine the reporting quality of clinical trials in this field. Methods: First, a systematic search is conducted for RCTs on CHMF in EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid-MEDLINE(R), Wanfang data, China National Knowledge Infrastructure (CNKI), VIP Chinese Medical Journal Database (VIP) and Chinese Biomedical Literature (CBM) database, that encompassed CHMF interventional RCTs published from 1 January 2018 to 8 June 2022, with language restriction to English or Chinese. Second, a descriptive analysis will be performed regarding the study design and general characteristics of the included trials. Third, for the quality assessment, we have subdivided the CONSORT-CHM Formula 2017 checklist (consisting of 22 extended items) into a total of 42 sub-questions to facilitate scoring, with a specific focus on the description, quality control, and safety assessment of CHMF interventions. Professional training and a pilot test on 100 randomly selected articles will be provided for all reviewers. Throughout this process, a standard operating procedure (SOP) for quality assessment will be developed to ensure consistency. Each item will be assessed by two reviewers in a paired back-to-back manner, and the compliance rate will be calculated to assess inter-rater agreement. Discussion: This review will identify the current reporting characteristics and quality of CHMF interventional studies and further evaluate the impact of CONSORT-CHM Formula 2017. The results may provide suggestions for future application or promotion of the guideline. Registration: The study has been registered on Open Science Framework (https://osf.io/xpn7f).

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OBJECTIVES: To describe, and explain the rationale for, the methods used and decisions made during development of the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines. METHODS: We developed SPIRIT 2024 and CONSORT 2024 together to facilitate harmonization of the two guidelines, and incorporated content from key extensions. We conducted a scoping review of comments suggesting changes to SPIRIT 2013 and CONSORT 2010, and compiled a list of other possible revisions based on existing SPIRIT and CONSORT extensions, other reporting guidelines, and personal communications. From this, we generated a list of potential modifications or additions to SPIRIT and CONSORT, which we presented to stakeholders for feedback in an international online Delphi survey. The Delphi survey results were discussed at an online expert consensus meeting attended by 30 invited international participants. We then drafted the updated SPIRIT and CONSORT checklists and revised them based on further feedback from meeting attendees. RESULTS: We compiled 83 suggestions for revisions or additions to SPIRIT and/or CONSORT from the scoping review and 85 from other sources, from which we generated 33 potential changes to SPIRIT (n = 5) or CONSORT (n = 28). Of 463 participants invited to take part in the Delphi survey, 317 (68%) responded to Round 1, 303 (65%) to Round 2 and 290 (63%) to Round 3. Two additional potential checklist changes were added to the Delphi survey based on Round 1 comments. Overall, 14/35 (SPIRIT n = 0; CONSORT n = 14) proposed changes reached the predefined consensus threshold (≥80% agreement), and participants provided 3580 free-text comments. The consensus meeting participants agreed with implementing 11/14 of the proposed changes that reached consensus in the Delphi and supported implementing a further 4/21 changes (SPIRIT n = 2; CONSORT n = 2) that had not reached the Delphi threshold. They also recommended further changes to refine key concepts and for clarity. CONCLUSION: The forthcoming SPIRIT 2024 and CONSORT 2024 Statements will provide updated, harmonized guidance for reporting randomized controlled trial protocols and results, respectively. The simultaneous development of the SPIRIT and CONSORT checklists has been informed by current empirical evidence and extensive input from stakeholders. We hope that this report of the methods used will be helpful for developers of future reporting guidelines.

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OBJECTIVE: The objective of this review is to provide an overview of the justification reported for using unequal allocation ratios in randomized clinical trials (RCTs) testing a medical intervention. METHODS: Using the PICOS framework, we conducted a systematic search to find meta-studies within PubMed (a Medline database interface) that addressed the objective. RESULTS: The developed search strategy generated 525 results, of which, three studies met criteria for inclusion. These studies found that 22-43% of RCTs provided a justification for the use of unequal allocation based on publication alone, and between 38.7 and 66% after seeking input from trial authors. The most common reason given for this design was to gather increased safety data according to two reviews and to gain experience with an intervention according to the third review. CONCLUSION: Reporting of justification for RCTs designed with unequal allocation appears to occur less than half the time in the included studies. The reasons given for designing clinical trials with unequal participants encompass many domains, including ethical considerations. As such, this design feature should be implemented with intentionality to maximize the ethical features of clinical trials for participants. Coupling lack of justification with lack of adjusting for sample size estimations depicts an overall landscape in which there is significant room for improvement in methodological transparency within this area of RCTs.

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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.

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The aim of this study was to explore adherence to the Consolidated Standards of Reporting Trials (CONSORT) reporting standards in abstracts of randomized controlled trials on glaucoma. A cross-sectional observational study was conducted on the aforementioned abstracts, indexed in MEDLINE/PubMed between the years 2017 and 2021. In total, 302 abstracts met the inclusion criteria and were further analyzed. The median score of CONSORT-A items was 8 (interquartile range, 7-10) out of 17 (47.0%). Most analyzed studies were conducted in a single center (80.5%) and the abstracts were predominantly structured (95.0%). Only 20.5% of the abstracts adequately described the trial design, while randomization and funding were described by 6.0% of the abstracts. Higher overall scores were associated with structured abstracts, a multicenter setting, statistically significant results, funding by industry, a higher number of participants, and having been published in journals with impact factors above four (p < 0.001, respectively). The results of this study indicate a suboptimal adherence to CONSORT-A reporting standards, especially in particular items such as randomization and funding. Since these factors could contribute to the overall quality of the trials and further translation of trial results into clinical practice, an improvement in glaucoma research reporting transparency is needed.

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BACKGROUND: Despite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial elements necessary to critically appraise and synthesize findings is prevalent. To harmonize and provide guidance for reporting in pediatric controlled clinical trial protocols and reports, reporting guideline extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines specific to pediatrics are being developed: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C). METHODS: The development of SPIRIT-C/CONSORT-C will be informed by the Enhancing the Quality and Transparency of Health Research Quality (EQUATOR) method for reporting guideline development in the following stages: (1) generation of a preliminary list of candidate items, informed by (a) items developed during initial development efforts and child relevant items from recent published SPIRIT and CONSORT extensions; (b) two systematic reviews and environmental scan of the literature; (c) workshops with young people; (2) an international Delphi study, where a wide range of panelists will vote on the inclusion or exclusion of candidate items on a nine-point Likert scale; (3) a consensus meeting to discuss items that have not reached consensus in the Delphi study and to "lock" the checklist items; (4) pilot testing of items and definitions to ensure that they are understandable, useful, and applicable; and (5) a final project meeting to discuss each item in the context of pilot test results. Key partners, including young people (ages 12-24 years) and family caregivers (e.g., parents) with lived experiences with pediatric clinical trials, and individuals with expertise and involvement in pediatric trials will be involved throughout the project. SPIRIT-C/CONSORT-C will be disseminated through publications, academic conferences, and endorsement by pediatric journals and relevant research networks and organizations. DISCUSSION: SPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste. TRIAL REGISTRATION: The development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35 ) and CONSORT-Children ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#CHILD ).

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