3R-Refinement principles: elevating rodent well-being and research quality.

This review article delves into the details of the 3R-Refinement principles as a vital framework for ethically sound rodent research laboratory. It highlights the core objective of the refinement protocol, namely, to enhance the well-being of laboratory animals while simultaneously improving the scientific validity of research outcomes. Through an exploration of key components of the refinement principles, the article outlines how these ethics should be implemented at various stages of animal experiments. It emphasizes the significance of enriched housing environments that reduce stress and encourage natural behaviors, non-restraint methods in handling and training, refined dosing and sampling techniques that prioritize animal comfort, the critical role of optimal pain management and the importance of regular animal welfare assessment in maintaining the rodents well-being. Additionally, the advantages of collaboration with animal care and ethics committees are also mentioned. The other half of the article explains the extensive benefits of the 3R-Refinement protocol such as heightened animal welfare, enhanced research quality, reduced variability, and positive feedback from researchers and animal care staff. Furthermore, it addresses avenues for promoting the adoption of the protocol, such as disseminating best practices, conducting training programs, and engaging with regulatory bodies. Overall, this article highlights the significance of 3R-Refinement protocol in aligning scientific advancement with ethical considerations along with shaping a more compassionate and responsible future for animal research.

In health research publications, the number of authors is strongly associated with collective self-citations but less so with citations by others.

OBJECTIVE: . This study investigated the associations between the number of authors and collective self-citations versus citations by others. STUDY DESIGN AND SETTING: . We analyzed 88,594 health science articles published in 2015 and citations they received until 2020. The main variables were the number of authors, the number of citations by co-authors (collective self-citations), and the number of citations by others. RESULTS: . The number of authors correlated more strongly with the number of citations by co-authors than with citations by others (Spearman r 0.31 vs. 0.23; mutually adjusted r 0.26 vs. 0.12). The percentage of self-citations among all citations was 10.6% for single-authored articles, and increased gradually with the number of authors to 34.8% for ≥ 50 authors. Collective self-citations increased the proportion of articles reaching or exceeding 30 total citations by 0.7% for single-authored articles, but by 11.6% for articles written by ≥ 50 authors. CONCLUSIONS: . If citations by others reflect scientific utility, then another mechanism must explain the excess of collective self-citations observed for multi-authored articles. The results support the hypothesis that the authors' own motivations explain this excess. The evaluation of scientific utility should also be based on citations by others, excluding collective self-citations.

Critical appraisal of recent translational chronopharmacology and chronotherapeutic reviews, meta-analyses, and pragmatic patient trials discloses significant deficiencies of design and conduct and suspect findings.

The conduct of molecular and laboratory animal circadian rhythm research has increased exponentially in the past few decades, such that today investigations are being performed by scientists of many diverse disciplines. Knowledge gained from past works is now being explored for translational applications to clinical medicine, often termed "circadian medicine," through the implementation of patient trials. However, these trials are being led, more often than not, by investigators who have little or no formal training and in-depth expertise in the methods of human circadian rhythm research, causing them to be deficient in design and produce dubious findings that have already led to unnecessary medical controversy at the expense of advances in patient care. Evidence of the very significant shortcomings of today's translational circadian medicine research is exemplified in two recent publications in well-read reputable medical journals concerning the chronotherapy of blood pressure (BP) medications: one a review and meta-analysis by Maqsood et al. published in the journal Hypertension in 2023 that pertains to ingestion-time differences in the extent of BP reduction exerted by hypertensive medications and the other a report by Mackenzie et al. in the journal Lancet in 2022 that details the results of the pragmatic TIME study that assessed ingestion-time differences in cardiovascular disease outcomes. Herein, we appraise the inaccurate trial selection, lack of quality assessment, and the numerous other shortcomings that culminated in suspect findings and faulty conclusions of the former, as well as the deficiencies in design and conduct of the latter using as reference the eight items identified in 2021 by a working committee of the International Society for Chronobiology and American Association for Medical Chronobiology and Chronotherapeutics as being necessary for high-quality research of circadian rhythm-dependencies of the therapeutic effects of BP-lowering medications. The TIME study when rated for its quality according to the extent to which its investigational methods satisfy all of the eight recommended items attains a very low overall score of + 1 out of a possible range of -1 to + 7. Moreover, our review of the methods of the currently ongoing pragmatic BedMed trial discloses major deficiencies of the same sort rending a poor quality score of + 0.5. Although the focus of this article is the appraisal of the quality of contemporary circadian medicine hypertension chronotherapy research, it additionally exposes the inadequacies and dubious quality of the critique of such manuscripts submitted for publication to influential journals, in that some peer reviewers might also be deficient in the knowledge required to properly rate their merit.

Predictors of 1-year enteral autonomy in children with intestinal failure: A descriptive retrospective cohort study.

INTRODUCTION: The International Intestinal Failure Registry (IIFR) is an international consortium to study intestinal failure (IF) outcomes in a large contemporary pediatric cohort. We aimed to identify predictors of early (1-year) enteral autonomy. METHODS: We included IIFR pilot phase patients. IF was defined by a parenteral nutrition need for at least 60 days due to a primary gastrointestinal etiology. The primary outcome was time to enteral autonomy achievement. We built a mixed-effects Weibull accelerated failure time model with random effects by center to analyze variables associated with enteral autonomy achievement with a primary outcome of time ratio (TR). RESULTS: We included 189 patients (82% with short bowel syndrome) representing 11 international centers. Cumulative incidence of early enteral autonomy was 51.6%, and death was 6.5%. In multivariable analysis, ostomy presence (TR, 2.63; 95% CI, 1.41-4.90) was associated with increased time to enteral autonomy achievement, and Asian/Indian (TR, 0.28; 95% CI, 0.10-0.81) and Pacific Islander race (TR, 0.34; 95% CI, 0.13-0.90) were associated with decreased time to enteral autonomy achievement. In a second model in the subset with measured percentage of bowel length remaining, ostomy presence (TR, 4.21; 95% CI, 1.90-9.33) was associated with increased time to enteral autonomy achievement, whereas greater percentage of bowel remaining (TR, 0.96; 95% CI, 0.94-0.98) was associated with decreased time to enteral autonomy achievement. CONCLUSIONS: Minimizing bowel resection at initial surgery and establishing bowel continuity by ostomy reversal can effectively decrease the time to early enteral autonomy achievement in children with IF.

Supporting Public Health Research Capacity, Quality, and Productivity in a Diverse Region.

Public health research plays a critical role in strengthening health systems and improving their performance and impact. However, scholarly production in public health coming from the Eastern Mediterranean Region (EMR) remains well below the world average and lacks a tangible growth trend over time. During the seventh Eastern Mediterranean Public Health Network Regional Conference, a roundtable session brought together a panel of public health experts representing Global Health Development/Eastern Mediterranean Public Health Network affiliates, universities or academia, and research institutions from the region, where they shared insights on the current situation of public health research; challenges and barriers to research facing the different countries in the EMR and the region in general; and how research agendas, productivity, and quality can be supported through strengthening research capacity in the region. Although the region is diverse in terms of health system capacity and socioeconomic development, several common challenges were identified, including a lack of strategic prioritization to guide health research, insufficient funding, ineffective transfer of knowledge to policy and practice, limited availability of research facilities, and limited national and international research collaboration. Occupied countries and countries in a state of conflict, such as Palestine, face additional barriers, such as personal and social security, lack of control of borders and natural resources, travel and movement restrictions, and confidentiality challenges because of the continuing war conditions and occupation. However, there have been success stories in the EMR regarding research publications and their positive and effective impact on policy and decision-makers. To improve research resilience and public health care in the region, a collaborative approach involving institutions, policymakers, and relevant stakeholders is critical.

Evaluating the quality of research co-production: Research Quality Plus for Co-Production (RQ + 4 Co-Pro).

BACKGROUND: Co-production is an umbrella term used to describe the process of generating knowledge through partnerships between researchers and those who will use or benefit from research. Multiple advantages of research co-production have been hypothesized, and in some cases documented, in both the academic and practice record. However, there are significant gaps in understanding how to evaluate the quality of co-production. This gap in rigorous evaluation undermines the potential of both co-production and co-producers. METHODS: This research tests the relevance and utility of a novel evaluation framework: Research Quality Plus for Co-Production (RQ + 4 Co-Pro). Following a co-production approach ourselves, our team collaborated to develop study objectives, questions, analysis, and results sharing strategies. We used a dyadic field-test design to execute RQ + 4 Co-Pro evaluations amongst 18 independently recruited subject matter experts. We used standardized reporting templates and qualitative interviews to collect data from field-test participants, and thematic assessment and deliberative dialogue for analysis. Main limitations include that field-test participation included only health research projects and health researchers and this will limit perspective included in the study, and, that our own co-production team does not include all potential perspectives that may add value to this work. RESULTS: The field test surfaced strong support for the relevance and utility of RQ + 4 Co-Pro as an evaluation approach and framework. Research participants shared opportunities for fine-tuning language and criteria within the prototype version, but also, for alternative uses and users of RQ + 4 Co-Pro. All research participants suggested RQ + 4 Co-Pro offered an opportunity for improving how co-production is evaluated and advanced. This facilitated our revision and publication herein of a field-tested RQ + 4 Co-Pro Framework and Assessment Instrument. CONCLUSION: Evaluation is necessary for understanding and improving co-production, and, for ensuring co-production delivers on its promise of better health.. RQ + 4 Co-Pro provides a practical evaluation approach and framework that we invite co-producers and stewards of co-production-including the funders, publishers, and universities who increasingly encourage socially relevant research-to study, adapt, and apply.

Responsible research practices could be more strongly endorsed by Australian university codes of research conduct.

BACKGROUND: This study aimed to investigate how strongly Australian university codes of research conduct endorse responsible research practices. METHODS: Codes of research conduct from 25 Australian universities active in health and medical research were obtained from public websites, and audited against 19 questions to assess how strongly they (1) defined research integrity, research quality, and research misconduct, (2) required research to be approved by an appropriate ethics committee, (3) endorsed 9 responsible research practices, and (4) discouraged 5 questionable research practices. RESULTS: Overall, a median of 10 (IQR 9 to 12) of 19 practices covered in the questions were mentioned, weakly endorsed, or strongly endorsed. Five to 8 of 9 responsible research practices were mentioned, weakly, or strongly endorsed, and 3 questionable research practices were discouraged. Results are stratified by Group of Eight (n = 8) and other (n = 17) universities. Specifically, (1) 6 (75%) Group of Eight and 11 (65%) other codes of research conduct defined research integrity, 4 (50%) and 8 (47%) defined research quality, and 7 (88%) and 16 (94%) defined research misconduct. (2) All codes required ethics approval for human and animal research. (3) All codes required conflicts of interest to be declared, but there was variability in how strongly other research practices were endorsed. The most commonly endorsed practices were ensuring researcher training in research integrity [8 (100%) and 16 (94%)] and making study data publicly available [6 (75%) and 12 (71%)]. The least commonly endorsed practices were making analysis code publicly available [0 (0%) and 0 (0%)] and registering analysis protocols [0 (0%) and 1 (6%)]. (4) Most codes discouraged fabricating data [5 (63%) and 15 (88%)], selectively deleting or modifying data [5 (63%) and 15 (88%)], and selective reporting of results [3 (38%) and 15 (88%)]. No codes discouraged p-hacking or hypothesising after results are known. CONCLUSIONS: Responsible research practices could be more strongly endorsed by Australian university codes of research conduct. Our findings may not be generalisable to smaller universities, or those not active in health and medical research.

Reducing Clinical Trial Monitoring Resources and Costs With Remote Monitoring: Retrospective Study Comparing On-Site Versus Hybrid Monitoring.

BACKGROUND: Clinical research associates (CRAs) monitor the progress of a trial, verify the data collected, and ensure that the trial is carried out and reported in accordance with the trial protocol, standard operating procedures, and relevant laws and regulations. In response to monitoring challenges during the COVID-19 pandemic, Peking University Cancer Hospital launched a remote monitoring system and established a monitoring model, combining on-site and remote monitoring of clinical trials. Considering the increasing digitization of clinical trials, it is important to determine the optimal monitoring model for the general benefit of centers conducting clinical trials worldwide. OBJECTIVE: We sought to summarize our practical experience of a hybrid model of remote and on-site monitoring of clinical trials and provide guidance for clinical trial monitoring management. METHODS: We evaluated 201 trials conducted by our hospital that used on-site monitoring alone or a hybrid monitoring model, of which 91 trials used on-site monitoring alone (arm A) and 110 used a hybrid model of remote and on-site monitoring (arm B). We reviewed trial monitoring reports from June 20, 2021, to June 20, 2022, and used a customized questionnaire to collect and compare the following information: monitoring cost of trials in the 2 models as a sum of the CRAs' transportation (eg, taxi fare and air fare), accommodation, and meal costs; differences in monitoring frequency; the number of monitored documents; and monitoring duration. RESULTS: From June 20, 2021, to June 20, 2022, a total of 320 CRAs representing 201 sponsors used the remote monitoring system for source data review and the verification of data from 3299 patients in 320 trials. Arm A trials were monitored 728 times and arm B trials were monitored 849 times. The hybrid model in arm B had 52.9% (449/849) remote visits and 48.1% (409/849) on-site visits. The number of patients' visits that could be reviewed in the hybrid monitoring model increased by 34% (4.70/13.80; P=.004) compared with that in the traditional model, whereas the duration of monitoring decreased by 13.8% (3.96/28.61; P=.03) and the total cost of monitoring decreased by 46.2% (CNY ¥188.74/408.80; P<.001). These differences were shown by nonparametric testing to be statistically significant (P<.05). CONCLUSIONS: The hybrid monitoring model can ensure timely detection of monitoring issues, improve monitoring efficiency, and reduce the cost of clinical trials and should therefore be applied more broadly in future clinical studies.

Safety and efficacy of direct percutaneous endoscopic jejunostomy placement in patients with previous upper gastrointestinal resection: A retrospective cohort study.

BACKGROUND: Percutaneous jejunal enteral access can be obtained with percutaneous endoscopic gastric jejunostomy (PEGJ) and direct percutaneous endoscopic jejunostomy (DPEJ) tubes. PEGJ may not be feasible in patients with previous gastric resection (PGR) and DPEJ may be the only option. Our aim is to determine if DPEJ tubes can be placed successfully in patients with history of gastrointestinal (GI) surgery and if success rates are comparable to DPEJ or PEGJ in those without prior GI surgery. METHODS: We reviewed all tube placements performed from 2010 to present. Procedures were performed using a pediatric colonoscope. Previous upper GI surgery was defined as PGR or esophagectomy with gastric pull-up. Adverse events (AEs) were graded per American Society for Gastrointestinal Endoscopy criteria. Mild events included unplanned medical consultation or hospitalization <3 days, and moderate events included repeat endoscopy without surgical intervention. RESULTS: Successful placement rates were high regardless of GI surgical history. Patients receiving a DPEJ with a history of GI surgery were significantly less likely to experience an AE compared with those receiving DPEJ with no history and compared with PEGJ patients with or without a history. CONCLUSIONS: DPEJ placement in patients with previous upper GI surgery has very high success rate. It is associated with lower AE rates than patients receiving DPEJ without previous gastric surgery, or PEGJ regardless of previous gastric surgery. Patients with a history of upper GI surgery requiring enteral access may benefit from DPEJ over PEGJ placement considering its very high success rate and lower incidence of AEs.

Survey analysis and discussion on cultivating scientific research quality among undergraduates in medical colleges.

To explore rational measures to improve medical undergraduates' scientific research quality by investigating and analyzing their scientific research situation. A questionnaire survey was conducted in March 2022 among medical college/university undergraduates across four grades and five majors. Five hundred and ninety-four questionnaires were distributed, and 553 valid copies were returned, with a 93.1% return rate. The results showed that 61.5% of the students had an intense interest in research experiments, and 46.8% thought it was important for undergraduates to participate in research experiments, but only 17.5% often participated in them. Among the students, 85.0% thought that the main factors preventing them from participating in research experiments were academic stress and insufficient time, and 82.6% hoped that mentors would focus on practical skills training; only 13.0% read literature at least once per week, and 93.5% were not proficient at organizing and using literature. Among the participating undergraduates, more than half were strongly interested in scientific research, but academic stress, unclear participation modes, and insufficient literature retrieval skills limited undergraduate scientific research practice and improvement of scientific quality. Therefore, it is essential to cultivate undergraduates' interest in scientific research, ensure that they have spare time to engage in scientific research, improve the undergraduate scientific research mentorship system, and enhance relevant scientific research abilities to cultivate more innovative talent in scientific research.

Is open science a double-edged sword?: data sharing and the changing citation pattern of Chinese economics articles.

Data sharing is an important part of open science (OS), and more and more institutions and journals have been enforcing open data (OD) policies. OD is advocated to help increase academic influences and promote scientific discovery and development, but such a proposition has not been elaborated on well. This study explores the nuanced effects of the OD policies on the citation pattern of articles by using the case of Chinese economics journals. China Industrial Economics (CIE) is the first and only Chinese social science journal so far to adopt a compulsory OD policy, requiring all published articles to share original data and processing codes. We use the article-level data and difference-in-differences (DID) approach to compare the citation performance of articles published in CIE and 36 comparable journals. Firstly, we find that the OD policy quickly increased the number of citations, and each article on average received 0.25, 1.19, 0.86, and 0.44 more citations in the first four years after publication respectively. Furthermore, we also found that the citation benefit of the OD policy rapidly decreased over time, and even became negative in the fifth year after publication. In conclusion, this changing citation pattern suggests that an OD policy can be double edged sword, which can quickly increase citation performance but simultaneously accelerate the aging of articles. Supplementary Information: The online version contains supplementary material available at 10.1007/s11192-023-04684-8.

Importance and use of guidelines to report main types of studies in medical research.

Medical care must be supported by research that meets reliable, valid, ethical, and reproducible principles. However, an essential fraction of research carried out in the medical field is inadequately reported due to omitting relevant information when it is published. This reduces their impact and the possibility that other researchers can realize critical appraisal, thereby compromising their application within medical practice. Because of this, guidelines have been developed to reduce this problem; their purpose is to increase research reports' methodological quality, transparency, validity, and reliability. Despite their importance, incorporating these guidelines in various journals and the knowledge and use by a significant part of the medical community is limited. In this context, this article aims to synthesize the main guidelines for reporting research in medicine.

La atención médica debe estar sustentada en investigaciones que cumplan principios confiables, válidos, éticos y reproducibles; sin embargo, una parte importante de las investigaciones realizadas en el campo médico son reportadas de manera inadecuada debido a que omiten información de trascendencia cuando son publicadas, lo cual disminuye su impacto y la posibilidad de que otros investigadores puedan evaluarlas de manera crítica y objetiva, comprometiendo con ello su aplicación dentro de la práctica médica. En un esfuerzo por atenuar este problema se han desarrollado guías cuya finalidad es incrementar la calidad metodológica, la transparencia, la validez y la fiabilidad de los reportes de investigación. No obstante su importancia, la incorporación de estas guías en diversas revistas, así como su conocimiento y utilización por una parte importante de la comunidad médica, son limitados. Dado este contexto, el objetivo del presente artículo es sintetizar las principales guías que existen para reportar investigaciones en medicina.

Half a Century of Fragmented Research on Deviations from Advised Therapies: Is This a Good Time to Call for Multidisciplinary Medication Adherence Research Centres of Excellence?

Medication adherence is a key precondition of the effectiveness of evidence-based therapies. However, in real-life settings, non-adherence to medication is still very common. This leads to profound health and economic consequences at both individual and public health levels. The problem of non-adherence has been extensively studied in the last 50 years. Unfortunately, with more than 130,000 scientific papers published on that subject so far, we are still far from finding an ultimate solution. This is, at least partly, due to fragmented and poor-quality research that has been conducted in this field sometimes. To overcome this deadlock, there is a need to stimulate the adoption of best practices in medication adherence-related research in a systematic way. Therefore, herein we propose the establishment of dedicated medication adherence research Centres of Excellence (CoEs). These Centres could not only conduct research but could also create a profound societal impact, directly serving the needs of patients, healthcare providers, systems and economies. Additionally, they could play a role as local advocates for good practices and education. In this paper, we propose some practical steps that might be taken in order to establish such CoEs. We describe two success stories, i.e., Dutch and Polish Medication Adherence Research CoEs. The COST Action "European Network to Advance Best practices & technoLogy on medication adherencE" (ENABLE) aims to develop a detailed definition of the Medication Adherence Research CoE in the form of a list of minimal requirements regarding their objectives, structure and activities. We hope that it will help to create a critical mass and catalyse the setup of regional and national Medication Adherence Research CoEs in the near future. This, in turn, may not only increase the quality of the research but also raise the awareness of non-adherence and promote the adoption of the best medication adherence-enhancing interventions.

Pediatric intestine transplant cost: Analysis of the Pediatric Health Information System database.

BACKGROUND: We aimed to evaluate costs from transplant to discharge in children who had undergone intestine transplant. METHODS: We performed a cross-sectional observational study of pediatric intestine transplant recipients from 2004 through 2020, utilizing the Pediatric Health Information System database. Standardized costs were applied to all charges and converted to 2021 US dollars. We analyzed the association of cost from transplant to discharge with age, sex, race and ethnicity, length of stay, insurance type, transplant year, short bowel syndrome diagnosis, liver-containing graft, hospitalization status, and immunosuppressive regimen. Predictors with a P value <0.20 in univariable analysis were included in a multivariable model, which was reduced using backwards selection with a P value of 0.05. RESULTS: We identified 376 intestinal transplant recipients across nine centers (median age, 2 years; 44% female). Most patients had short bowel syndrome (294; 78%). The liver was included in 218 transplants (58%). Median posttransplant cost was $263,724 (interquartile range [IQR], $179,564-$384,147), and length of stay was 51.5 days (IQR, 34-77). In the final model, increased cost from transplant to hospital discharge was associated with liver-containing graft (+$31,805; P = 0.028), T-cell-depleting antibody use (+$77,004; P < 0.001), and mycophenolate mofetil use (+$50,514; P = 0.012) while controlling for insurance type and length of stay. A 60-day posttransplant hospital stay would cost an estimated $272,533. CONCLUSIONS: Intestine transplant has high immediate cost and long length of stay that varies by center, graft type, and immunosuppression regimen. Future work will examine the cost-effectiveness of various management strategies before and after transplant.

Evaluating the Ability of Open-Source Artificial Intelligence to Predict Accepting-Journal Impact Factor and Eigenfactor Score Using Academic Article Abstracts: Cross-sectional Machine Learning Analysis.

BACKGROUND: Strategies to improve the selection of appropriate target journals may reduce delays in disseminating research results. Machine learning is increasingly used in content-based recommender algorithms to guide journal submissions for academic articles. OBJECTIVE: We sought to evaluate the performance of open-source artificial intelligence to predict the impact factor or Eigenfactor score tertile using academic article abstracts. METHODS: PubMed-indexed articles published between 2016 and 2021 were identified with the Medical Subject Headings (MeSH) terms "ophthalmology," "radiology," and "neurology." Journals, titles, abstracts, author lists, and MeSH terms were collected. Journal impact factor and Eigenfactor scores were sourced from the 2020 Clarivate Journal Citation Report. The journals included in the study were allocated percentile ranks based on impact factor and Eigenfactor scores, compared with other journals that released publications in the same year. All abstracts were preprocessed, which included the removal of the abstract structure, and combined with titles, authors, and MeSH terms as a single input. The input data underwent preprocessing with the inbuilt ktrain Bidirectional Encoder Representations from Transformers (BERT) preprocessing library before analysis with BERT. Before use for logistic regression and XGBoost models, the input data underwent punctuation removal, negation detection, stemming, and conversion into a term frequency-inverse document frequency array. Following this preprocessing, data were randomly split into training and testing data sets with a 3:1 train:test ratio. Models were developed to predict whether a given article would be published in a first, second, or third tertile journal (0-33rd centile, 34th-66th centile, or 67th-100th centile), as ranked either by impact factor or Eigenfactor score. BERT, XGBoost, and logistic regression models were developed on the training data set before evaluation on the hold-out test data set. The primary outcome was overall classification accuracy for the best-performing model in the prediction of accepting journal impact factor tertile. RESULTS: There were 10,813 articles from 382 unique journals. The median impact factor and Eigenfactor score were 2.117 (IQR 1.102-2.622) and 0.00247 (IQR 0.00105-0.03), respectively. The BERT model achieved the highest impact factor tertile classification accuracy of 75.0%, followed by an accuracy of 71.6% for XGBoost and 65.4% for logistic regression. Similarly, BERT achieved the highest Eigenfactor score tertile classification accuracy of 73.6%, followed by an accuracy of 71.8% for XGBoost and 65.3% for logistic regression. CONCLUSIONS: Open-source artificial intelligence can predict the impact factor and Eigenfactor score of accepting peer-reviewed journals. Further studies are required to examine the effect on publication success and the time-to-publication of such recommender systems.

Reporting guidelines used varying methodology to develop recommendations.

BACKGROUND AND OBJECTIVES: We investigated the developing methods of reporting guidelines in the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network's database. METHODS: In October 2018, we screened all records and excluded those not describing reporting guidelines from further investigation. Twelve researchers performed duplicate data extraction on bibliometrics, scope, development methods, presentation, and dissemination of all publications. Descriptive statistics were used to summarize the findings. RESULTS: Of the 405 screened records, 262 described a reporting guidelines development. The number of reporting guidelines increased over the past 3 decades, from 5 in the 1990s and 63 in the 2000s to 157 in the 2010s. Development groups included 2-151 people. Literature appraisal was performed during the development of 56% of the reporting guidelines; 33% used surveys to gather external opinion on items to report; and 42% piloted or sought external feedback on their recommendations. Examples of good reporting for all reporting items were presented in 30% of the reporting guidelines. Eighteen percent of the reviewed publications included some level of spin. CONCLUSION: Reporting guidelines have been developed with varying methodology. Reporting guideline developers should use existing guidance and take an evidence-based approach, rather than base their recommendations on expert opinion of limited groups of individuals.

Methodological and Quality Flaws in the Use of Artificial Intelligence in Mental Health Research: Systematic Review.

BACKGROUND: Artificial intelligence (AI) is giving rise to a revolution in medicine and health care. Mental health conditions are highly prevalent in many countries, and the COVID-19 pandemic has increased the risk of further erosion of the mental well-being in the population. Therefore, it is relevant to assess the current status of the application of AI toward mental health research to inform about trends, gaps, opportunities, and challenges. OBJECTIVE: This study aims to perform a systematic overview of AI applications in mental health in terms of methodologies, data, outcomes, performance, and quality. METHODS: A systematic search in PubMed, Scopus, IEEE Xplore, and Cochrane databases was conducted to collect records of use cases of AI for mental health disorder studies from January 2016 to November 2021. Records were screened for eligibility if they were a practical implementation of AI in clinical trials involving mental health conditions. Records of AI study cases were evaluated and categorized by the International Classification of Diseases 11th Revision (ICD-11). Data related to trial settings, collection methodology, features, outcomes, and model development and evaluation were extracted following the CHARMS (Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies) guideline. Further, evaluation of risk of bias is provided. RESULTS: A total of 429 nonduplicated records were retrieved from the databases and 129 were included for a full assessment-18 of which were manually added. The distribution of AI applications in mental health was found unbalanced between ICD-11 mental health categories. Predominant categories were Depressive disorders (n=70) and Schizophrenia or other primary psychotic disorders (n=26). Most interventions were based on randomized controlled trials (n=62), followed by prospective cohorts (n=24) among observational studies. AI was typically applied to evaluate quality of treatments (n=44) or stratify patients into subgroups and clusters (n=31). Models usually applied a combination of questionnaires and scales to assess symptom severity using electronic health records (n=49) as well as medical images (n=33). Quality assessment revealed important flaws in the process of AI application and data preprocessing pipelines. One-third of the studies (n=56) did not report any preprocessing or data preparation. One-fifth of the models were developed by comparing several methods (n=35) without assessing their suitability in advance and a small proportion reported external validation (n=21). Only 1 paper reported a second assessment of a previous AI model. Risk of bias and transparent reporting yielded low scores due to a poor reporting of the strategy for adjusting hyperparameters, coefficients, and the explainability of the models. International collaboration was anecdotal (n=17) and data and developed models mostly remained private (n=126). CONCLUSIONS: These significant shortcomings, alongside the lack of information to ensure reproducibility and transparency, are indicative of the challenges that AI in mental health needs to face before contributing to a solid base for knowledge generation and for being a support tool in mental health management.

Association between congenital heart disease and parenteral nutrition-associated liver disease in neonates: A retrospective cohort study.

OBJECTIVE: Infants receiving parenteral nutrition (PN) are at increased risk of PN-associated liver disease (PNALD), which can lead to hepatic fibrosis. Congenital heart disease (CHD) represents a risk factor for hepatic fibrosis, so this study sought to better understand whether infants with CHD were at elevated risk of PNALD when receiving long-term PN. STUDY DESIGN: This study includes a retrospective cohort of infants at a level IV neonatal intensive care unit from 2010 to 2020 who received long-term PN during the first 8 weeks of life. A time-varying Cox survival model was used to model risk of PNALD between infants with and without CHD, adjusted for demographics, surgical intervention, and PN exposure, using a 5000-iteration bootstrap estimation. Secondary analyses evaluated risk against discrete CHD diagnoses, and sensitivity analysis was performed on the magnitude and quantity of direct bilirubin laboratory measurements making up the PNALD definition. RESULTS: Neonates with CHD were found to be at higher risk for PNALD during or soon after long-term PN exposure. A pattern of increasing association strength with increasing bilirubin threshold suggests infants with CHD may also experience higher degrees of injury. CONCLUSIONS: This work offers a step in understanding how diagnoses can be factored into neonate PN prescription. Future work will explore modifications in lipid profiles and timing to mitigate risk in patients with CHD.

Can pioglitazone be used for optimization of nutrition in critical illness? A systematic review.

BACKGROUND: Skeletal muscle wasting is a determinant of physical disability in survivors of critical illness. Intramuscular bioenergetic failure, altered substrate metabolim, and inflammation are likely underpinning mechanisms. We examined the effect of pioglitazone, a peroxisome proliferator-activated receptor γ agonist, on muscle-related outcomes in adults. METHODS: We included randomized controlled trials in which pioglitazone was administered (no dose/dosage restrictions) and muscle-related outcomes were reported. We searched MEDLINE, CENTRAL, EMBASE, CINAHL, and trial registries. Risk of bias was assessed using RoB 2. Primary outcomes were physical function and symptoms, muscle mass and function, or body composition and muscular compositional change. Secondary outcomes included muscle insulin sensitivity, mitochondrial effects, and intramuscular inflammation. RESULTS: Fourteen studies over 19 publications (n = 474 patients) were included. Lean body mass was unaffected in three studies (n = 126) and increased by 1.8-1.92 kg in two studies (P = 0.02 and 0.003, respectively; n = 48). Pioglitazone was associated with increased peripheral insulin sensitivity (+23%-72%, standardized mean difference of 0.97 from trial start point to end point [95% CI, 0.36-1.58; n = 213]). Treatment reduced intramuscular tumor necrosis factor-α (TNF-α) levels (-30%; P = 0.02; n = 29), with mixed effects on serum TNF-α and intramyocellular lipid concentrations. Treatment increased intramuscular markers of adenosine triphosphate (ATP) biosynthesis (ATP5A [+33%, P ≤ 0.05], ETFA [+60%, P ≤ 0.05], and CX6B1 [+ 33%, P = 0.01] [n = 24]), PGC1α and PGC1ß messenger RNA expression (P < 0.05; n = 26), and AMPK phosphorylation (+38%, P < 0.05; n = 26). These data have low-quality evidence profiles owing to risk of bias. CONCLUSIONS: Pioglitazone therapy increases skeletal muscle insulin sensitivity and can decrease intramuscular inflammation.