Evolution of Research Reporting Standards: Adapting to the Influence of Artificial Intelligence, Statistics Software, and Writing Tools.

Reporting standards are essential to health research as they improve accuracy and transparency. Over time, significant changes have occurred to the requirements for reporting research to ensure comprehensive and transparent reporting across a range of study domains and foster methodological rigor. The establishment of the Declaration of Helsinki, Consolidated Standards of Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) are just a few of the historic initiatives that have increased research transparency. Through enhanced discoverability, statistical analysis facilitation, article quality enhancement, and language barrier reduction, artificial intelligence (AI)-in particular, large language models like ChatGPT-has transformed academic writing. However, problems with errors that could occur and the need for transparency while utilizing AI tools still exist. Modifying reporting rules to include AI-driven writing tools such as ChatGPT is ethically and practically challenging. In academic writing, precautions for truth, privacy, and responsibility are necessary due to concerns about biases, openness, data limits, and potential legal ramifications. The CONSORT-AI and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-AI Steering Group expands the CONSORT guidelines for AI clinical trials-new checklists like METRICS and CLEAR help to promote transparency in AI studies. Responsible usage of technology in research and writing software adoption requires interdisciplinary collaboration and ethical assessment. This study explores the impact of AI technologies, specifically ChatGPT, on past reporting standards and the need for revised guidelines for open, reproducible, and robust scientific publications.

A standard to report biological variation data studies - based on an expert opinion.

There is a need for standards for generation and reporting of Biological Variation (BV) reference data. The absence of standards affects the quality and transportability of BV data, compromising important clinical applications. To address this issue, international expert groups under the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) have developed an online resource (https://tinyurl.com/bvmindmap) in the form of an interactive mind map that serves as a guideline for researchers planning, performing and reporting BV studies. The mind map addresses study design, data analysis, and reporting criteria, providing embedded links to relevant references and resources. It also incorporates a checklist approach, identifying a Minimum Data Set (MDS) to enable the transportability of BV data and incorporates the Biological Variation Data Critical Appraisal Checklist (BIVAC) to assess study quality. The mind map is open to access and is disseminated through the EFLM BV Database website, promoting accessibility and compliance to a reporting standard, thereby providing a tool to be used to ensure data quality, consistency, and comparability of BV data. Thus, comparable to the STARD initiative for diagnostic accuracy studies, the mind map introduces a Standard for Reporting Biological Variation Data Studies (STARBIV), which can enhance the reporting quality of BV studies, foster user confidence, provide better decision support, and be used as a tool for critical appraisal. Ongoing refinement is expected to adapt to emerging methodologies, ensuring a positive trajectory toward improving the validity and applicability of BV data in clinical practice.

Evaluating a clinical mentorship intervention on maternal and neonatal complications in primary health facilities in Blantyre district, Malawi: A longitudinal analysis of the Global Action in Nursing program.

BACKGROUND: While Malawi has made great strides increasing the number of facility-based births, maternal and neonatal mortality remains high. An intervention started in 2019 provided short-course training followed by year-long longitudinal bedside mentorship for nurse midwives at seven health facilities in Blantyre district. The intervention was initiated following invitation from the district to improve outcomes for patients during childbirth. This study examined the impact of the intervention on the reporting of obstetric and neonatal complications and related care. METHODS: Patient level data were collected from the District Health Information System 2 database from intervention and non-intervention facilities. Bivariate analysis explored the impact of longitudinal bedside mentorship on select District Health Information System 2 variables at six-month intervals. Outcomes were then analyzed using nonlinear quantile mixed models to better account for the impact of time and clustering at the facility level. RESULTS: Significant changes were found in the reporting of obstetric and neonatal complications over time at intervention facilities compared to non-intervention facilities. Intervention facilities showed statistically significant increases in the reporting of prolonged labor, pre/eclampsia, fetal distress, retained placenta, and premature labor. There was also a statistically significant decrease in the reporting of no complications in the multivariate model (95%CI: -0.8 to -0.2). In both the bivariate and multivariate models, the reporting of 'None' significantly decreased (0.8 % median), while the reporting of prematurity (0.2 % median) and asphyxia (0.3 % median) both significantly increased. The missingness of data at intervention facilities decreased to almost zero compared to non-intervention facilities. DISCUSSION: The increase in reported maternal and neonatal complications suggests improved early identification of complications at the facility level. The improved accuracy of patient data from intervention facilities shows the impact mentorship has on data quality which is crucial for the allocation of resources. By highlighting the apparent dose-response relationship of longitudinal bedside mentorship, this study will inform the broader use of mentorship in training programs. Future research is needed to explore the impact of longitudinal mentorship on quality of care.

Self-acknowledged limitations in exercise therapy trials for low back pain.

RATIONALE: Despite the widespread recommendation to engage in therapeutic exercise for the treatment of low back pain (LBP), there is conflicting evidence regarding clinical outcomes and effectiveness. Poor methodological quality may be to blame for reducing the overall strength of evidence for this intervention, yet little is known about the difficulties researchers encounter when designing and implementing their study methods. AIMS AND OBJECTIVES: The aim of this study was to characterize the extent and type of self-acknowledged limitations (SALs) in exercise therapy trials for LBP to gain a better understanding of challenges encountered when conducting this research. METHODS: This is a methodological review of clinical trials in which SALs were extracted, categorized by theme and subcategorized within each theme. Counts and prevalence rates were tabulated for the number of SALs in each category and subcategory. RESULTS: There were 914 SALs among the 312 included trials, with a mean of 2.93 (95% confidence interval [CI], 2.77-3.09) per trial. Analysis of the data resulted in the development of 13 distinct categories of limitations, among which were 37 subcategories. The top three categories pertained to statistical power (14.3% of total SALs), study length and/or follow-up (14.3%) and inclusion criteria (14.2%). The top three subcategories were lack of long-term follow-up (13.8% of total SALs), inadequate sample size (13.3%) and inclusion of specific populations (12.3%). CONCLUSION: Statistical power, study length and/or follow-up, and inclusion criteria were the three most commonly reported categories of SALs in exercise trials for LBP. Lack of long-term follow-up, inadequate sample size and inclusion of specific populations were the most common subcategories. Research protocols recognizing and avoiding these limitations will enhance the overall quality of evidence of exercise therapy trials for LBP.

[Enhanced quality of documentation for biologic therapy of chronic rhinosinusitis through structured digital reporting and indication?] / Qualitätssteigerung der Dokumentation zur Biologikatherapie der chronischen Rhinosinusitis durch digitale, strukturierte Befunderhebung und Indikationsstellung?

BACKGROUND: With targeted inhibition of type 2 inflammation, biologics represent the standard add-on therapy for inadequately controlled severe forms of chronic rhinosinusitis with nasal polyps (CRSwNP). Despite standardization with paper-based checklists, the documentation of medical history and current findings pertinent to indication criteria are a significant challenge for physicians. Through development of an application based on structured reporting, the current study aimed to improve documentation quality and simplify the decision-making process. Previously available paper checklists served as a comparison. METHODS: For this study, a digital incremental tool was programmed to record current findings and check for fulfilment of indication criteria. The tool was compared with other checklists in terms of completeness, time required, and readability. RESULTS: A total of 20 findings were collected for each of the three documentation options and included in the analysis. Documentation with the two paper-based checklists had comparable information content: 17.5 ± 5.1/21.7 ± 7.6 points out of a maximum of 43 points; p > 0.05. Documentation using the digital application led to a significant increase in information content compared to all paper-based documentation. The average score was 38.25 ± 3.7 (88.9% of maximum; p < 0.001). On average, user satisfaction was high (9.6/10). Use of the digital application was initially more time consuming, but as more cases were documented, the time taken improved significantly. CONCLUSION: In the future, structured reporting using apps could replace paper-based reporting for the indication of biologic therapy in CRSwNP patients and offer additional benefits in terms of data quality and traceability of results. The increasing volume of documentation in the future, the progress of digitalization, and the possibility of networking between individual centers make introduction of the app in the near future both likely and economical.

Undercounting diagnoses in Australian general practice: a data quality study with implications for population health reporting.

BACKGROUND: Diagnosis can often be recorded in electronic medical records (EMRs) as free-text or using a term with a diagnosis code. Researchers, governments, and agencies, including organisations that deliver incentivised primary care quality improvement programs, frequently utilise coded data only and often ignore free-text entries. Diagnosis data are reported for population healthcare planning including resource allocation for patient care. This study sought to determine if diagnosis counts based on coded diagnosis data only, led to under-reporting of disease prevalence and if so, to what extent for six common or important chronic diseases. METHODS: This cross-sectional data quality study used de-identified EMR data from 84 general practices in Victoria, Australia. Data represented 456,125 patients who attended one of the general practices three or more times in two years between January 2021 and December 2022. We reviewed the percentage and proportional difference between patient counts of coded diagnosis entries alone and patient counts of clinically validated free-text entries for asthma, chronic kidney disease, chronic obstructive pulmonary disease, dementia, type 1 diabetes and type 2 diabetes. RESULTS: Undercounts were evident in all six diagnoses when using coded diagnoses alone (2.57-36.72% undercount), of these, five were statistically significant. Overall, 26.4% of all patient diagnoses had not been coded. There was high variation between practices in recording of coded diagnoses, but coding for type 2 diabetes was well captured by most practices. CONCLUSION: In Australia clinical decision support and the reporting of aggregated patient diagnosis data to government that relies on coded diagnoses can lead to significant underreporting of diagnoses compared to counts that also incorporate clinically validated free-text diagnoses. Diagnosis underreporting can impact on population health, healthcare planning, resource allocation, and patient care. We propose the use of phenotypes derived from clinically validated text entries to enhance the accuracy of diagnosis and disease reporting. There are existing technologies and collaborations from which to build trusted mechanisms to provide greater reliability of general practice EMR data used for secondary purposes.

A survey into the current fitness testing practices of elite male soccer practitioners: from assessment to communicating results.

This study provides insight into the current fitness testing practices in elite male soccer. One hundred and two practitioners from professional soccer leagues across 24 countries completed an online survey comprising 29 questions, with five sections: a) background information, b) testing selection, c) testing implementation, d) data analysis, and e) data reporting. Frequency analysis was used to evaluate the responses to fixed response questions and thematic analysis was used for open-ended questions to generate clear and distinct themes. Strength (85%) and aerobic capacity (82%) represent the most frequently assessed physical qualities. Scientific literature (80%) is the most influential factor in testing selection and practitioners conduct fitness testing less frequently than their perceived ideal frequency per season (3.6 ± 2 vs. 4.5 ± 2). Time and competitive schedule were the greatest barriers to fitness testing administration. Practitioners mostly used a 'hybrid' approach (45%) to fitness testing, blending 'traditional' (i.e., a day dedicated to testing) and 'integrated' (i.e., testing within regular training sessions) methods. Microsoft Excel is the most used software for data analysis (95%) and visualization (79%). An equal use of the combination of best and mean scores of multiple trials (44%) and the best score (42%) was reported. Comparing a player's test performance with previous scores (89%) was the most common method for interpreting test results. However, only 38% considered measurement error. Digital displays and verbal feedback are the most common data reporting methods, with different data reporting processes for coaches and players. Practitioners can use data and findings from this study to inform their current testing practices and researchers to further identify areas for investigation, with the overarching aim of developing the field of fitness testing in elite male soccer.

Agreement of Gallbladder Reporting and Data System for Gallbladder Wall Thickening at Ultrasonography: A Multireader Validation Study.

Objective: This article aims to evaluate the intrareader and interreader agreement of ultrasound (US) gallbladder reporting and data system (GB-RADS) and validate the risk of malignancy in each GB-RADS category. Materials and methods: This retrospective study comprised consecutive patients with nonacute gallbladder wall thickening who underwent US evaluation between January 2019 and December 2022. Three radiologists independently read the static US images and cine-loops for GB-RADS findings and assigned GB-RADS categories. The intraobserver (static images) and interobserver (static images and cine-loops) agreement was calculated using kappa statistics and Krippendorff's alpha. Another radiologist assigned a consensus GB-RADS category. The percentage of malignancy in each GB-RADS category was calculated. Results: Static US images of 414 patients (median age, 56 years; 288 women, benign = 45.6% and malignant = 54.4%) and cine-loops of 50 patients were read. There was weak to moderate intrareader agreement for most GB-RADS findings and moderate intrareader agreement for the GB-RADS category for all readers. On static images, the interreader agreement was acceptable for GB-RADS categories. On cine-loops, the interreader agreement for GB-RADS findings and categories was better than static images. The percentage of malignancy was 1.2%, 37%, 71.1%, and 89.1% in GB-RADS 2, 3, 4, and 5 categories. Conclusion: GB-RADS has moderate intrareader for GB-RADS categories. As originally proposed, the risk of malignancy is negligible in GB-RADS 2 category and highest in GB-RADS 5 category. However, the discriminatory performance of GB-RADS 3 and 4 categories is low. Larger multicenter studies with more readers must assess the reader agreement and validate the GB-RADS systems for wider clinical utilization.

A retrospective analysis of serious adverse events and deaths in U.S.-based lifestyle clinical trials for cognitive health.

Objective: This retrospective analysis examined serious adverse events (SAEs) and deaths in U.S. lifestyle clinical trials aimed at enhancing cognitive health in older adults. Methods: Data was gathered from trials completed between January 1, 2000, and July 19, 2023, via ClinicalTrials.gov's API. Results: Among these trials, 76% did not report results. The remaining studies fell into four intervention categories: Cognitive/Behavioral, Exercise/Movement, Diet/Supplement, and Multi-modal. When considering all trial types collectively, the findings suggest that lifestyle clinical trials are generally safe. There was no significant increase in the relative risk of experiencing an SAE in the intervention group compared to the control group. However, in terms of relative risk of death, an increase of 28% was observed in the intervention compared to the control, which was statistically significant (X2 (1, N = 36), p < 0.00688). Nevertheless, this increase did not surpass age-adjusted U.S. mortality rates. Assessing the data by intervention type, Diet/Supplement, and Multi-modal trials displayed an elevated relative risk of SAEs in the intervention. Diet/Supplement trials had a 16% increase (X2 (1, N = 2), p < 0.0263), and Multi-modal trials had a 365% increase (X2 (1, N = 5), p < 0.000213). Diet/Supplement trials also showed a 67% increased risk of death (X2 (1, N = 2), p < 0.000197). Conclusions: These findings should be cautiously considered due to the low rate of reporting, but underscore the significance of reporting clinical trial results, enhancing transparency, and facilitating more accurate safety assessments in cognitive aging and lifestyle interventions for older adults.

Making Oneself "Fit": Community Perspectives on Disaggregated Race and Ethnicity Data Collection and Reporting in Healthcare Settings.

Patient race/ethnicity data collection in most U.S. health systems abide by federal standards, determined by the federal Office of Management and Budget. Yet, decades of research show that reliance on these categories alone limits understanding of within-group health disparities, systematically erasing key groups from health data. Because granular race/ethnicity data is complex and patients may be hesitant to disclose this personal information, it is important for health leaders to consider community perspectives when making decisions about race/ethnicity data procedures. As such, this study uses community focus groups to understand: (1) how individuals representing different racial/ethnic identities perceive the collection of race/ethnicity in healthcare settings; (2) differences in opinions between disaggregated race/ethnicity data collection instruments and those using federal standards; and (3) recommended practices for collecting race/ethnicity from patients. Participants self-selected into 13 focus groups and one key informant interview based on the race/ethnicity with which they most closely identified. Audio recordings from these groups were transcribed and evaluated using thematic content analysis. Among the 83 total participants in this study, there was a strong preference for more flexible and specific options for self-identifying race/ethnicity in healthcare settings. Participants also felt comfortable disclosing granular race/ethnicity to health providers but expressed discomfort with disclosing this information for other purposes. Recommendations for healthcare leaders include ensuring patients receive detailed communication about race/ethnicity data use and purpose, allowing multiple category selection, keeping the list of disaggregated response options short so as to not overwhelm patients, and providing a free text option to ensure inclusivity.

Development of regional pharmacy intravenous admixture services data reporting and analysis platform for enhanced quality control ability.

BACKGROUND: Pharmacy intravenous admixture service (PIVAS) center has emerged as an important department of hospitals as it can improve occupational protection and ensure the safety and effectiveness of intravenous infusions. However, there is little research on the standardized capability and risk evaluation of PIVAS by using modern information technology. In this research, we established Regional Pharmacy Intravenous Admixture Services Data Reporting and Analysis Platform (RPDRAP) to improve quality control ability for PIVAS management. RPDRAP including evaluation matrix for quality control monitoring. The construction of platform is based on guidelines for the Construction and Management of PIVAS and management specifications of PIVAS in China. METHODS: RPDRAP was established in 2018. This platform comprises a data collection system and a data analysis system. The data collection system consists of 67 data items. Data collection relied on online platforms through data acquisition module. The collected data were analyzed using a model with 20 indicators within the data analysis system. Fifteen hospitals, public comprehensive healthcare facilities with more than 500 beds, participated in the platform's application evaluation. RESULTS: The study revealed significant differences in PIVAS total score, supervisors, and workload between 2020 and 2022. The platform's application results demonstrated improvements in personnel management, work efficiency, and infection control within these PIVAS. Although statistical significance was observed in only 8 out of the 25 items, most of the scores showed an increase, with a small portion remaining unchanged and no decline in scores. CONCLUSIONS: This platform can be recommended for PIVAS homogeneous and regional efficient management. The use of this platform not only improves the quality control ability of PIVAS but also enables the management department to quickly grasp the current situation and characteristics of each PIVAS through standardized data collection and analysis.

Contrast-enhanced mammography BI-RADS: a case-based approach to radiology reporting.

Contrast-enhanced mammography (CEM) is a relatively recent diagnostic technique increasingly being utilized in clinical practice. Until recently, there was a lack of standardized reporting for CEM findings. However, this has changed with the publication of a supplement in the Breast Imaging Reporting and Data System (BI-RADS). A comprehensive understanding of CEM is essential for further enhancing its role in both screening and managing patients with breast malignancies. CEM can also be beneficial for problem-solving, improving the management of uncertain breast findings. Practitioners in this field should become more cognizant of how and when to employ this technique and interpret the various CEM findings. This paper aims to outline the key findings in the updated version of the BI-RADS specifically dedicated to CEM. Additionally, it will present some clinical cases commonly encountered in clinical practice.Critical relevance statement Standardized reporting and a thorough understanding of CEM findings are pivotal for advancing the role of CEM in screening and managing breast cancer patients. This standardization contributes significantly to integrating CEM as an essential component of daily clinical practice.Key points • A complete knowledge and understanding of the findings outlined in the new BI-RADS CEM are necessary for accurate reporting.• BI-RADS CEM supplement is intuitive and practical to use.• Standardization of the CEM findings enables more accurate patient management.

STROBE, CONSORT, PRISMA, MOOSE, STARD, SPIRIT, and other guidelines - Overview and application.

The purpose of research is to seek answers and new knowledge. When conducted properly and systematically, research adds to humanity's corpus of knowledge and hence to our general advancement. However, this is only possible if reported research is accurate and transparent. Guidelines for all the major types of studies (STROBE, CONSORT, PRISMA, MOOSE, STARD, and SPIRIT) have been developed and refined over the years, and their inception, development, and application are briefly discussed in this paper. Indeed, there are currently over 250 of these guidelines for various types of medical research, and these are published by the EQUATOR network. This paper will also briefly review progress in acceptance and adoption of these guidelines.

A rapid review of current engagement strategies with people who use drugs in monitoring and reporting on substance use-related harms.

BACKGROUND: The Canadian drug supply has significantly increased in toxicity over the past few years, resulting in the worsening of the overdose crisis. A key initiative implemented during this crisis has been data monitoring and reporting of substance use-related harms (SRH). This literature review aims to: (1) identify strategies used for the meaningful engagement of people who use drugs (PWUD) in local, provincial, and national SRH data system planning, reporting, and action and (2) describe data monitoring and reporting strategies and common indicators of SRH within those systems. METHODS: We searched three academic and five gray literature databases for relevant literature published between 2012 and 2022. Team members who identify as PWUD and a librarian at Public Health Ontario developed search strings collaboratively. Two reviewers screened all search results and applied the eligibility criteria. We used Microsoft Excel for data management. RESULTS: Twenty-two articles met our eligibility criteria (peer-reviewed n = 10 and gray literature reports n = 12); most used qualitative methods and focused on the Canadian context (n = 20). There were few examples of PWUD engaged as authors of reports on SRH monitoring. Among information systems involving PWUD, we found two main strategies: (1) community-based strategies (e.g., word of mouth, through drug sellers, and through satellite workers) and (2) public health-based data monitoring and communication strategies (e.g., communicating drug quality and alerts to PWUD). Substance use-related mortality, hospitalizations, and emergency department visits were the indicators most commonly used in systems of SRH reporting that engaged PWUD. CONCLUSION: This review demonstrates limited engagement of PWUD and silos of activity in existing SRH data monitoring and reporting strategies. Future work is needed to better engage PWUD in these processes in an equitable manner. Building SRH monitoring systems in partnership with PWUD may increase the potential impact of these systems to reduce harms in the community.

A systematic review of exercise studies for individuals hospitalized with an acute exacerbation of chronic obstructive pulmonary disease: Focus on the principles of exercise training.

BACKGROUND: For exercise interventions to be effectively reproduced or applied in a "real world" clinical setting, clinical trials must thoroughly document all components of the exercise prescription and ensure that participants adhere to each component. However, previous reviews have not critically examined the quality of exercise prescription of inpatient Pulmonary Rehabilitation (PR) programs. OBJECTIVE: The objectives of this review were to evaluate the (a) application of the principles of exercise training, (b) reporting of the frequency, intensity, time and type (FITT) components of exercise prescription, and (c) reporting of patient's adherence to the FITT components in intervention studies for patients admitted to hospital for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). METHODS: Relevant scientific databases were searched for randomized controlled trials (RCTs) that compared in-hospital PR with usual care for people hospitalized with AECOPD. Title and abstract followed by full-text screening were conducted independently by two reviewers. Data were extracted and synthesized to evaluate the application of the principles of exercise training and the reporting/adherence of the FITT components. RESULTS: Twenty-seven RCTs were included. Only two applied all principles of exercise training. Specificity was applied by 70%, progression by 48%, overload by 37%, initial values by 89% and diminishing returns and reversibility by 37% of trials. Ten trials adequately reported all FITT components. Frequency and type were the components most reported (85% and 81%, respectively), while intensity was less frequently reported (52%). Only three trials reported on the patient's adherence to all four components. CONCLUSIONS: Studies have not adequately reported the exercise prescription in accordance with the principles of exercise training nor reported all the FITT components of the exercise prescription and patient's adherence to them. Therefore, interpretation of the current literature is limited and information for developing exercise prescriptions to individuals hospitalized with an AECOPD is lacking.

Understanding the trade-offs of national municipal solid waste estimation methods for circular economy policy.

Policies embracing circular economy concepts have taken hold in national legislation around the world. As the number of governments and organizations adopting circular economy policies increases, so does the need for accurate and timely measurement of material resource flows. Since many countries do not have access to centrally reported municipal solid waste (MSW) data, estimation and modeling are critical in evaluating circular economy policy effectiveness. The purpose of this paper is to examine three modeling approaches estimating national MSW data in the United States, including industry-based material flow analysis, waste-extended input-output modeling, and aggregated regional waste reporting. We establish five criteria to guide the analysis through the context of policy monitoring (data quality, flow totality, update frequency, sensitivity to disruption, and product granularity) and use these criteria to analyze and score each model. We then use a literature search to identify five, internationally-implemented options for circular economy policy and determine the data and modeling components that are most helpful in evaluating policy effectiveness. Finally, we provide a crosswalk of the model scores and policy needs to inform the suitability of model selection by policy type. We found that data quality and update frequency are identified as critical components for evaluating circular economy policies within the models evaluated, and can both be fulfilled by aggregated regional waste reporting. Flow totality, sensitivity to disruption, and product granularity requirements vary by both model and policy types. While none of the evaluated models satisfy the combination of requirements for any of the five policies, industry-based material flow analysis offers flow totality for extended producer responsibility, landfill bans, and recycling rate target policies that typically require it. The waste-extended input-output model can provide disruption sensitivity and product granularity as needed for policies like minimum recycled content and market restrictions. Policy developers in areas where strong centralized data collection is not an option should design policy action(s) with modeling tradeoffs in mind, including the potential hybridization of modeling approaches that may provide the most accurate national MSW estimates.

A Retrospective Analysis of Serious Adverse Events and Deaths in US-Based Lifestyle Clinical Trials for Cognitive Health.

This retrospective analysis assessed the serious adverse events and deaths reported in lifestyle clinical trials designed to enhance cognitive health in older adults living in the United States. Data was collected from studies conducted between January 1, 2000, and July 19, 2023, using the ClinicalTrials.gov application programming interface. Our query revealed that 76% of these studies did not report trial results. The remaining studies with reported results were categorized under one of four intervention types: Cognitive/Behavioral, Exercise/Movement, Diet/Supplement, and Multi-modal. When all trial types are considered together, the results indicate that lifestyle clinical trials are safe, with no significant increase in relative risk of experiencing an SAE in an intervention group over a control group. And although the increase in relative risk of death in an intervention group over a control group was significant at 28% (X2 (1, N = 36), p < 0.00688), the probability of death was not higher than the U.S. mortality rates by age. When assessing the data using intervention type, Diet/Supplement trials and Multi-modal trials both had an increase in relative risk of experiencing an SAE in the intervention over the control group, with Diet/Supplement trials at 16% (X2 (1, N = 2), p < 0.0263) and Multi-modal trials at 365% (X2 (1, N = 5), p < 0.000213). The Diet/Supplement trials also had an increased risk of death at 67% (X2 (1, N = 2), p < 0.000197). These results should be taken with careful consideration. Due to such a low reporting rate, the 36 studies included in this analysis do not accurately represent the majority of lifestyle clinical trials conducted in the U.S. This study is valuable in that it highlights the importance of reporting clinical trial results, which will improve transparency in trial results and allow for more accurate assessments of safety in the growing field of cognitive aging and lifestyle interventions for older adults.

Schroth Physiotherapeutic Scoliosis-Specific Exercise (PSSE) Trials-Systematic Review of Methods and Recommendations for Future Research.

The Schroth method is a non-operative treatment for scoliosis and kyphosis, used standalone or as an adjunct to bracing. While supporting evidence for its effectiveness is emerging, methodologic standardization and rigor are equivocal. Thus, we aimed to systematically review methods of published Schroth physiotherapeutic scoliosis-specific exercise (PSSE) trials and provide guidance for future research. We searched six databases for randomized controlled trials (RCT) and non-randomized studies of interventions (NRSIs) investigating the effect of Schroth in children and adults with scoliosis or kyphosis. General characteristics, methodological approaches, treatment protocols, and outcomes reporting were analyzed. Risk of bias (RoB) was assessed using an adapted Cochrane RoB2 tool for RCTs and ROBINS-I for NRSI. Eligible studies (n = 7) were conducted in six countries and included patients with Scheuermann's kyphosis (n = 1) and adolescent idiopathic scoliosis (n = 6). Though all seven studies used the term Schroth to describe their interventions, the Schroth method was used in four of seven studies, of which only one used Schroth classification, three used Schroth therapists, and none prospectively registered the study protocol. Overall, methodological rigor was suboptimal, potentially invalidating evidence synthesis. Authors should follow minimum standards for reporting, including prospectively registering detailed protocols; using appropriate exercise labeling, Schroth classification and certified therapists; naming and describing exercises per classification; and providing therapy dosages, prescription methods, and adherence.

Tolerogenic dendritic cell reporting: Has a minimum information model made a difference?

Minimum information models are reporting frameworks that describe the essential information that needs to be provided in a publication, so that the work can be repeated or compared to other work. In 2016, Minimum Information about Tolerogenic Antigen-Presenting cells (MITAP) was created to standardize the reporting on tolerogenic antigen-presenting cells, including tolerogenic dendritic cells (tolDCs). tolDCs is a generic term for dendritic cells that have the ability to (re-)establish immune tolerance; they have been developed as a cell therapy for autoimmune diseases or for the prevention of transplant rejection. Because protocols to generate these therapeutic cells vary widely, MITAP was deemed to be a pivotal reporting tool by and for the tolDC community. In this paper, we explored the impact that MITAP has had on the tolDC field. We did this by examining a subset of the available literature on tolDCs. Our analysis shows that MITAP is used in only the minority of relevant papers (14%), but where it is used the amount of metadata available is slightly increased over where it is not. From this, we conclude that MITAP has been a partial success, but that much more needs to be done if standardized reporting is to become common within the discipline.

Published registry-based pharmacoepidemiologic associations show limited concordance with agnostic medication-wide analyses.

OBJECTIVES: To assess how the results of published national registry-based pharmacoepidemiology studies (where select associations are of interest) compare with an agnostic medication-wide approach (where all possible drug associations are tested). STUDY DESIGN AND SETTING: We systematically searched for publications that reported drug associations with any, breast, colon/colorectal, or prostate cancer in the Swedish Prescribed Drug Registry. Results were compared against a previously performed agnostic medication-wide study on the same registry. PROTOCOL: https://osf.io/kqj8n. RESULTS: Most published studies (25/32) investigated previously reported associations. 421/913 (46%) associations had statistically significant results. 134 of the 162 unique drug-cancer associations could be paired with 70 associations in the agnostic study (corresponding drug categories and cancer types). Published studies reported smaller effect sizes and absolute effect sizes than the agnostic study, and generally used more adjustments. Agnostic analyses were less likely to report statistically significant protective associations (based on a multiplicity-corrected threshold) than their paired associations in published studies (McNemar odds ratio 0.13, P = 0.0022). Among 162 published associations, 36 (22%) showed increased risk signal and 25 (15%) protective signal at P < 0.05, while for agnostic associations, 237 (11%) showed increased risk signal and 108 (5%) protective signal at a multiplicity-corrected threshold. Associations belonging to drug categories targeted by individual published studies vs. nontargeted had smaller average effect sizes; smaller P values; and more frequent risk signals. CONCLUSION: Published pharmacoepidemiology studies using a national registry addressed mostly previously proposed associations, were mostly "negative", and showed only modest concordance with their respective agnostic analyses in the same registry.