Participant Flow Diagram Research Articles

Participant flow diagrams for health equity in AI

Selection bias can arise through many aspects of a study, including recruitment, inclusion/exclusion criteria, input-level exclusion and outcome-level exclusion, and often reflects the underrepresentation of populations historically disadvantaged in medical research. The effects of selection bias can be further amplified when non-representative samples are used in artificial intelligence (AI) and machine learning (ML) applications to construct clinical algorithms. Building on the “Data Cards” initiative for transparency in AI research, we advocate for the addition of a participant flow diagram for AI studies detailing relevant sociodemographic and/or clinical characteristics of excluded participants across study phases, with the goal of identifying potential algorithmic biases before their clinical implementation. We include both a model for this flow diagram as well as a brief case study explaining how it could be implemented in practice. Through standardized reporting of participant flow diagrams, we aim to better identify potential inequities embedded in AI applications, facilitating more reliable and equitable clinical algorithms.

Quality of reporting of randomized controlled trials of top 10 herbs prescribed in Thailand

IntroductionGiven the questionable quality of reporting of randomized controlled trials (RCTs) of herbal interventions, especially in developing countries, this study aims to evaluate the quality of reporting of RCTs of the top 10 herbs prescribed in Thailand and published in Thai healthcare journals. MethodsA systematic search was conducted within five databases: PubMed, Cochrane Library, Thai Journal Online, Thai Index Medicus, and Online Public Access Catalog of Khon Kaen University for Thai and English herbal medicine intervention RCTs published in Thai healthcare journals. Reporting quality of RCTs was assessed by using adapted CONSORT Herbal Intervention and CONSORT 2010 comprised of 52 items. ResultsOf 1351 potential studies, 16 RCTs met the eligibility criteria. For the quality of reporting by each item of 16 included studies, 27 of 52 items were reported in at least 50 % of RCTs which data on participants, physical characteristics of the herbal product, similarity of interventions, baseline data, numbers analyzed, ancillary analyses, and generalizability were reported in all included RCTs when applicable. However, 20 items had less than 50 % reported in included RCTs. There were no included RCTs reported information on the participant flow diagram, registration, and protocol. Discussion/ConclusionsThe quality of reporting of Thai herbal invention RCTs published in Thai healthcare journals was suboptimal. Improvement in the reporting quality of Thai herbal RCTs was needed to provide a high level of evidence. Relevant Thai healthcare journals should encourage Thai herbal medicine RCT authors to follow the CONSORT statement and herbal medicine intervention extensions.

Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan

BackgroundThe LOVIT (Lessening Organ Dysfunction with Vitamin C) trial is a blinded multicenter randomized clinical trial comparing high-dose intravenous vitamin C to placebo in patients admitted to the intensive care unit with proven or suspected infection as the main diagnosis and receiving a vasopressor.ObjectiveWe aim to describe a prespecified statistical analysis plan (SAP) for the LOVIT trial prior to unblinding and locking of the trial database.MethodsThe SAP was designed by the LOVIT principal investigators and statisticians, and approved by the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes, and describes the planned primary, secondary, and subgroup analyses.ResultsThe SAP includes a draft participant flow diagram, tables, and planned figures. The primary outcome is a composite of mortality and persistent organ dysfunction (receipt of mechanical ventilation, vasopressors, or new renal replacement therapy) at 28 days, where day 1 is the day of randomization. All analyses will use a frequentist statistical framework. The analysis of the primary outcome will estimate the risk ratio and 95% CI in a generalized linear mixed model with binomial distribution and log link, with site as a random effect. We will perform a secondary analysis adjusting for prespecified baseline clinical variables. Subgroup analyses will include age, sex, frailty, severity of illness, Sepsis-3 definition of septic shock, baseline ascorbic acid level, and COVID-19 status.ConclusionsWe have developed an SAP for the LOVIT trial and will adhere to it in the analysis phase.International Registered Report Identifier (IRRID)DERR1-10.2196/36261

Abstract P-039: DEFINING LONG-STAY PATIENTS IN THE PEDIATRIC INTENSIVE CARE UNIT: A SURVEY OF MEDICAL DIRECTORS, NURSE MANAGERS AND HOSPITAL ADMINISTRATORS

Aims & Objectives: Long-stay patients (LSPs) account for ~8% of admissions to pediatric intensive care units (PICUs) and use up to 50% of hospital resources, but there is no consensus definition for LSPs. Therefore, we surveyed key PICU stakeholders to assess their perspectives regarding the importance of defining LSPs, the components the definition should include, the preferred method for deriving the definition, and the definitions’ characteristics. Methods We identified a purposive sample of one medical director, nurse manager and hospital administrator in each of 14 tertiary care academic PICUs across Canada. An internet-based survey was sent to 40 of 42 eligible participants in February and March of 2017. Results The participant flow diagram is shown in Figure 1. We had a response rate of 70% (28/40). 75% (21/28) of respondents stated it was important to define LSPs. Respondents thought such a definition was important to determine: PICU resource needs (86%, 18/21), alternative models of care (86%, 18/21), and current resource utilization (76%, 16/21) (Table 1). Respondents valued a definition that was consistent, and incorporated a percentile cut-off. 86% of respondents (24/28) felt the definition of LSPs should include factors other than PICU length of stay (Table 2).Conclusions PICU stakeholders believed defining LSPs is important. They indicated that this definition should be consistent, include a percentile cut-off for length of stay, and incorporate patient and unit-based factors along with PICU length of stay. Our results provide a basis for developing a consensus definition for LSPs in the PICU.

Methodologic Quality and Statistical Reporting of Physical Therapy Randomized Controlled Trials Relevant to Musculoskeletal Conditions

ObjectivesTo investigate the methodologic quality and statistical reporting of reports of trials indexed on the Physiotherapy Evidence Database (PEDro) classified in the musculoskeletal subdiscipline, and to analyze the characteristics of the trials that can predict trial report quality. DesignCross-sectional study based on a collection of randomized controlled trials. We randomly selected 19% of trials coded as musculoskeletal from PEDro. Methodologic quality was assessed using the PEDro scale. We assessed aspects of the trial using 9 items from the Consolidated Standards of Reporting Trials (CONSORT) statement. We performed multivariate linear regression analysis models to predict the total PEDro score. SettingNot applicable. ParticipantsNot applicable. InterventionsNot applicable. Main Outcome MeasuresNot applicable. ResultsA total of 1404 articles were included in the analysis. The mean total PEDro scale score was 5.27±1.63 points, which reflects low methodologic quality. There was a slight improvement in the quality of articles over time. The characteristics that predicted the total PEDro scale score were endorsement of the CONSORT statement, sample size calculation, lower number of primary outcomes, evaluation of electrotherapy as intervention, if the trial reported the research design in the title, reporting of participant flow diagram, years since publication (most recent trials), and trials published in English. ConclusionsThe quality of the trials in musculoskeletal physical therapy is suboptimal. The use of reporting checklists (eg, CONSORT statement) should be mandatory in all journals. Journal reviewers and journal editors should also use the CONSORT statement during the review process.

The Content of Statistical Requirements for Authors in Biomedical Research Journals.

Background:Robust statistical designing, sound statistical analysis, and standardized presentation are important to enhance the quality and transparency of biomedical research. This systematic review was conducted to summarize the statistical reporting requirements introduced by biomedical research journals with an impact factor of 10 or above so that researchers are able to give statistical issues’ serious considerations not only at the stage of data analysis but also at the stage of methodological design.Methods:Detailed statistical instructions for authors were downloaded from the homepage of each of the included journals or obtained from the editors directly via email. Then, we described the types and numbers of statistical guidelines introduced by different press groups. Items of statistical reporting guideline as well as particular requirements were summarized in frequency, which were grouped into design, method of analysis, and presentation, respectively. Finally, updated statistical guidelines and particular requirements for improvement were summed up.Results:Totally, 21 of 23 press groups introduced at least one statistical guideline. More than half of press groups can update their statistical instruction for authors gradually relative to issues of new statistical reporting guidelines. In addition, 16 press groups, covering 44 journals, address particular statistical requirements. The most of the particular requirements focused on the performance of statistical analysis and transparency in statistical reporting, including “address issues relevant to research design, including participant flow diagram, eligibility criteria, and sample size estimation,” and “statistical methods and the reasons.”Conclusions:Statistical requirements for authors are becoming increasingly perfected. Statistical requirements for authors remind researchers that they should make sufficient consideration not only in regards to statistical methods during the research design, but also standardized statistical reporting, which would be beneficial in providing stronger evidence and making a greater critical appraisal of evidence more accessible.

Randomized controlled trials of herbal interventions underreport important details of the intervention

Objective To examine the quality of reporting and predictors of reporting in randomized clinical trials (RCTs) of herbal medicine interventions. Study Design and Setting We searched Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, and Academy of Microscope Enhanced Dentistry up to December 2007 for any English language RCT of 11 commonly used herbal medicine interventions. Two individuals separately and independently assessed all trials using the Consolidated Standards of Reporting Trials (CONSORT) checklist for herbal medicines interventions. We randomly selected 100 of these trials, extracted a set of potential predictor variables identified through a literature search and consultation with experts, and performed a conceptually driven stepwise elimination regression analyses for predictor variables. Results The 406 trials reported on average 38% of the information suggested in the checklist. Regression analyses revealed better overall reporting in trials with a participant flow diagram ( P = 0.008), those of Panax quinquefolius ( P = 0.018), and those published in more recent years ( P = 0.02). Conclusion Our results indicate that RCTs of herbal medicine interventions frequently do not report important characteristics of the intervention. Trialists should refer to the CONSORT for herbal medicines when reporting their trials.

Editorial policies aimed at improving the transparency and validity of published research

Byline: T. Sathyanarayana Rao, Prathap. Tharyan Research published in local and national journals, such as the Indian Journal of Psychiatry , is as important as research published in international journals, in order to contextualize the evidence on which healthcare and health policy needs are to be based. [sup][1] However, the quality of research published in local and national journals, particularly those from low and middle-income countries, is often considered inferior to that of research articles published in international journals. [sup][2] If these research findings are used to guide clinical practice, health outcomes may be adversely affected. Editorial policies, and adherence to these policies, determine to a large extent the quality of reporting of research published in journals. [sup][3] The duties of medical journal editors include, among others, safeguarding the rights of the study participants; establishing policies of submission, review and acceptance of manuscripts; and working towards improving the quality of the conduct and publication of research. [sup][4] These can be aided by the unambiguous endorsement of standards that improve transparency in reporting research and by the provision of clear instructions to authors about what is expected of them. The instructions to authors in the Indian Journal of Psychiatry have therefore been amended to endorse internationally accepted reporting standards that are appropriate for the research design used. Authors of manuscripts are expected to adhere to these instructions when preparing manuscripts for submission in order to increase the chances that their manuscripts will be accepted. These amendments will also aid peer reviewers to readily identify whether the submitted manuscript meets the criteria for transparency in research reporting. Endorsing the ICMJE Uniform Requirements and use of Design-Specific Reporting Standards The Indian Journal of Psychiatry continues to endorse the submission of manuscripts in accordance with the Uniform Requirements for Manuscripts Submitted to Biomedical Journals of the International Committee of Medical Journal Editors (ICMJE); [sup][5] the web-link to the ICMJE requirements has now been provided to enable authors to access the requirements in their entirety. The Uniform Requirements endorse design-specific reporting standards, and the revised instructions to authors now provide links to the appropriate guidance for interventional observational studies, and qualitative research, and for reports comparing the accuracy of diagnostic tests. Consort 2010 Authors of randomized clinical trials are now required not only to prepare and submit their manuscripts in accordance with the CONSORT 2010 statement, [sup][6],[7] but also to use the appropriate extensions of the CONSORT statement for trial designs that differ from the standard parallel-group trial or that use herbal interventions, and on reporting harms. [sup][8],[9],[10],[11],[12],[13] Authors are also expected to submit, along with the manuscript, the CONSORT checklist and participant flow diagram. The web-links to templates for both that can be downloaded and appropriately modified have also been provided. The former will not be published with the trial report but will aid effective peer review by stating exactly where in the manuscript the required CONSORT element can be found. The latter will be published and will provide information that will aid interpretation of the generalizability of the results by disclosing details of those excluded from the trial so that the reader can evaluate the proportions excluded, particularly for not fulfilling inclusion criteria. It will also disclose the proportions in each trial arm that completed the various stages of the trial, thus making it possible to evaluate if the analysis of the results was complete. Strobe Most research published in this journal are observational in nature and authors are required to follow the guidance provided in the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement for reporting observational studies, typically cross-sectional studies, case-control studies and cohort studies. …

Reporting of compliance in randomised controlled trials investigating the effect of maternal nutritional supplementation on infant outcomes

The Consolidated Standards of Reporting Trials (CONSORT) group comprises medical journal editors, epidemiologists and clinical trialists and was established in 1996 with the aim of developing scales to assess the quality of randomised controlled trial (RCT) reports. The group have since developed several evidence-based initiatives to improve the reporting of RCT. One of these initiatives is the Revised CONSORT Statement (1) that is made up of a checklist and participant flow diagram to be utilised by authors when reporting trials. The participant flow diagram specifies the data that should be reported to describe the progress of participants through a trial. It is recommended that the number of participants that ‘received’ the treatment and the number that ‘discontinued’ treatment be stated. The flow chart does not, however, specify that the percentage of participants complying with the treatment protocol be reported. This information is particularly important in long-term supplementation trials where poor compliance may influence the way in which study findings are interpreted. The aim of the present study was to investigate the adequacy of reporting of: (1) participant flow data as recommended by CONSORT; (2) participant compliance data (using criteria developed for the purpose of the current study) from RCT that studied the effect of maternal nutritional supplementation during pregnancy on neonatal and infant outcomes including birth weight, mortality and nutritional status. A literature search of MEDLINE, EMBASE, CINAHL and AMED databases was carried out using the following combination of

An analysis of general medical and specialist journals that endorse CONSORT found that reporting was not enforced consistently

Background We aimed to determine if specialist journals implement specific Consolidated Standards for Reporting Trials (CONSORT) recommendations to the same extent as general medical journals. Methods Analysis of random controlled trials (RCTs) in five general medical journals ( n = 100) and 10 specialist journals ( n = 100), all endorsing CONSORT. We evaluated the likelihood of reporting important methodologic criteria. Analyses controlled for the nested effect of journal within each journal type. Results General medical journals published, on average, more CONSORT items per RCT than specialist journals (7.9 [SD 1.8] vs. 6.5 [SD 2.2] out of 11 possible items, P = .02). When compared with specialist journals, RCTs in general medical journals published a participant flow diagram more frequently (83 vs. 42%, odds ratio [OR] 6.7, 95% confidence interval [CI] 3.4–12.9) and more likely to report the method of randomization (78 vs. 55%, OR 2.9, 95% CI 1.5–5.3) and allocation concealment (48 vs. 26%, OR 2.6, 95% CI 1.4–4.7); they were less likely to publish RCTs reporting adverse events (58 vs. 78%, OR 0.3, 95% CI 0.2–0.7). Both page length and impact factor were weakly associated with number of CONSORT items reported. Conclusion General medical and specialist journals that endorse CONSORT do not enforce reporting issues consistently, with specialty journals lagging behind general medical journals.

The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement

If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting Trials (CONSORT) were developed to improve the suboptimal reporting of RCTs. We aimed to determine the extent to which RCTs report key methodological factors included in the revised CONSORT recommendations following publication of these recommendations. We conducted an observational study of RCTs published between July 2002 and June 2003 in 5 leading general medicine journals. We determined the proportion and 95% confidence intervals of RCTs that reported sequence generation, allocation concealment, randomization implementation, blinding status of participants, health care providers, outcome assessors, and data analysts, sample size justification, method of analysis (e.g. intention-to-treat), and a participant flow diagram. We included a total of 253 RCTs. RCTs reported: sequence generation 80% (95% CI 75–80%), allocation concealment 48% (95% CI 42–54%), randomization implementation 55% (95% CI 49–61%), blinding status of participants 40% (34–46%), health care providers 17% (95% CI 13–22%), outcome assessors 47% (95% CI 41–53%), data analysts 15% (10–19%), sample size justification 83% (95% CI 78–87%), method of analysis 87% (95% CI 83–91%)), and participant flow diagrams 86% (95% CI 82–90%). Although reporting of some CONSORT recommendations is high, reporting of several essential recommendations remains suboptimal. Authors need to comply with and journals need to enforce reporting of the revised CONSORT recommendations.

Determining the reporting quality of RCTs in clinical pharmacology.

The Consolidated Standards for Reporting Trials (CONSORT) are recommendations for improving the quality of reports of randomized controlled trials (RCTs). To determine the extent to which clinical pharmacology journals implement specific CONSORT recommendations. Analysis of RCTs published between May 2002 and May 2003 in four clinical pharmacology journals. Proportion of RCTs that published a participant flow diagram and that reported on randomization and restriction methods, allocation concealment, blinding, intention-to-treat analysis, ethical considerations, adverse events and source of funding. Of 482 clinical trials, 193 were RCTs. Healthy participants were involved in 129 [66.8%, 95% confidence interval (CI) 59.9, 73.1] trials, patients who required treatment in 61 (31.6%, 95% CI 25.4, 38.4) trials and both in three (1.6%, 95% CI 0.5, 4.4) trials. The following items were infrequently reported: sequence generation (17%), allocation concealment (3%), use of restriction (16%), description of blinding (26%), and flow diagrams of study participants (2%). In contrast, the following areas were often reported: use of intention-to-treat analysis (79%), description of withdrawals (92.2%) and description of adverse events (71%), ethics review (94%) and informed consent (95%). Sources of funding were reported in 56% of studies. The use of the selected CONSORT items is limited in these journals, possibly as many items may not be relevant to the types of studies published in clinical pharmacology journals. Further efforts are required to determine the applicability of CONSORT to RCTs in clinical pharmacology.