Completeness of intervention reporting of nutrition-focused weight management interventions adjunct to metabolic and bariatric surgery: effect of the TIDieR checklist.

Nutrition-focused interventions are essential to optimize the bariatric care process and improve health and weight outcomes over time. Clear and detailed reporting of these interventions in research reports is crucial for understanding and applying the findings effectively in clinical practice and research replication. Given the importance of reporting transparency in research, this study aimed to use the Template for Intervention Description and Replication (TIDieR) checklist to evaluate the completeness of intervention reporting in nutritional weight management interventions adjunct to metabolic and bariatric surgery (MBS). The secondary aim was to examine the factors associated with better reporting. A literature search in PubMed, PsychINFO, EMBASE, Scopus, and the Cochrane Controlled Register of Trials was conducted to include randomized controlled trials (RCT), quasi-RCTs and parallel group trials. A total of 22 trials were included in the final analysis. Among the TIDieR 12 items, 6.6 ± 1.9 items were fully reported by all studies. None of the studies completely reported all intervention descriptors. The main areas where reporting required improvement were providing adequate details of the materials and procedures of the interventions, intervention personalization, and intervention modifications during the study. The quality of intervention reporting remained the same after vs. before the release of the TIDieR guidelines. Receiving funds from industrial organizations (p = 0.02) and having the study recorded within a registry platform (p = 0.08) were associated with better intervention reporting. Nutritional weight management interventions in MBS care are still below the desirable standards for reporting. The present study highlights the need to improve adequate reporting of such interventions, which would allow for greater replicability, evaluation through evidence synthesis studies, and transferability into clinical practice.

Epidemiology and reporting characteristics of preclinical systematic reviews.

In an effort to better utilize published evidence obtained from animal experiments, systematic reviews of preclinical studies are increasingly more common-along with the methods and tools to appraise them (e.g., SYstematic Review Center for Laboratory animal Experimentation [SYRCLE's] risk of bias tool). We performed a cross-sectional study of a sample of recent preclinical systematic reviews (2015-2018) and examined a range of epidemiological characteristics and used a 46-item checklist to assess reporting details. We identified 442 reviews published across 43 countries in 23 different disease domains that used 26 animal species. Reporting of key details to ensure transparency and reproducibility was inconsistent across reviews and within article sections. Items were most completely reported in the title, introduction, and results sections of the reviews, while least reported in the methods and discussion sections. Less than half of reviews reported that a risk of bias assessment for internal and external validity was undertaken, and none reported methods for evaluating construct validity. Our results demonstrate that a considerable number of preclinical systematic reviews investigating diverse topics have been conducted; however, their quality of reporting is inconsistent. Our study provides the justification and evidence to inform the development of guidelines for conducting and reporting preclinical systematic reviews.

Commentary: Taking stock and moving forward - the need to consider the influence of loss to follow-up in autism screening research.

This commentary highlights the limitations of many existing population-based studies examining the utility of the Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) in screening for autism. We expound on three major factors: (a) the limited number of screen-negative children who undergo diagnostic evaluations, (b) the substantial number of children who screen positive and were subsequently lost to follow-up (i.e. without further diagnostic evaluations), and (c) the sizeable number of children who did not complete the full two-stage screening process as intended. Each of these factors can lead to erroneous estimates of the psychometric properties, specifically, the sensitivity, specificity, and negative predictive value. Hence, we emphasize the need for future studies to increase the number of children who screen negative and receive a diagnostic evaluation and ensure that these children are selected at random without a higher likelihood for the presence of autism. It is also imperative that concrete steps are taken to minimize the number of screen-positive children who are lost to follow-up both within and after the screening process. Both of these will play a major role in ensuring more robust results from empirical research that can guide the clinical implementation of the M-CHAT-R/F.

Systematic Review Assessing Quality of the Survey Literature in Surgery.

INTRODUCTION: The use of survey methodology in surgical research has proliferated in recent years, but the quality of these surveys and of their reporting is understudied. METHODS: We conducted a comprehensive review of surgical survey literature (January 2022-July 2023) via PubMed in July 2023. Articles which (1) reported data gleaned from a survey, (2) were published in an English language journal, (3) targeted survey respondents in the United States or Canada, and (4) pertained to general surgery specialties were included. We assessed quality of survey reports using the Checklist for Reporting Of Survey Studies (CROSS) guidelines. Articles were evaluated for concordance with CROSS using a dichotomous (yes or no) scale. RESULTS: Initial literature search yielded 481 articles; 57 articles were included in analysis based on the inclusion criteria. The mean response rate was 37% (range 0.62%-98%). The majority of surveys were administered electronically (n = 50, 87.8%). No publications adhered to all 40 CROSS items; on average, publications met 61.2% of items applicable to that study. Articles were most likely to adhere to reporting criteria for title and abstract (mean adherence 99.1%), introduction (99.1%), and discussion (92.4%). Articles were least adherent to items related to methodology (42.6%) and moderately adherent to items related to results (76.6%). Only five articles cited CROSS guidelines or another standardized survey reporting tool (10.5%). CONCLUSIONS: Our analysis demonstrates that CROSS reporting guidelines for survey research have not been adopted widely. Surveys reported in surgical literature may be of variable quality. Increased adherence to guidelines could improve development and dissemination of surveys done by surgeons.

A deeper consideration of sex/gender in quantitative health research: a checklist for incorporating multidimensionality, variety, embodiment, and intersectionality throughout the whole research process.

BACKGROUND: There is a growing awareness of the need to adequately integrate sex and gender into health-related research. Although it is widely known that the entangled dimensions sex/gender are not comprehensively considered in most studies to date, current publications of conceptual considerations and guidelines often only give recommendations for certain stages of the research process and - to the best of our knowledge - there is a lack of a detailed guidance that accompanies each step of the entire research process. The interdisciplinary project "Integrating gender into environmental health research" (INGER) aimed to fill this gap by developing a comprehensive checklist that encourages sex/gender transformative research at all stages of the research process of quantitative health research. In the long term this contributes to a more sex/gender-equitable research. METHODS: The checklist builds on current guidelines on sex/gender in health-related research. Starting from important key documents, publications from disciplines involved in INGER were collected. Furthermore, we used a snowball method to include further relevant titles. The identification of relevant publications was continued until saturation was reached. 55 relevant publications published between 2000 and 2021 were identified, assessed, summarised and included in the developed checklist. After noticing that most publications did not cover every step of the research process and often considered sex/gender in a binary way, the recommendations were modified and enriched based on the authors' expertise to cover every research step and to add further categories to the binary sex/gender categories. RESULTS: The checklist comprises 67 items in 15 sections for integrating sex/gender in quantitative health-related research and addresses aspects of the whole research process of planning, implementing and analysing quantitative health studies as well as aspects of appropriate language, communication of results to the scientific community and the public, and research team composition. CONCLUSION: The developed comprehensive checklist goes beyond a binary consideration of sex/gender and thus enables sex/gender-transformative research. Although the project INGER focused on environmental health research, no aspects that were specific to this research area were identified in the checklist. The resulting comprehensive checklist can therefore be used in different quantitative health-related research fields.

Application of causal inference methods in individual-participant data meta-analyses in medicine: addressing data handling and reporting gaps with new proposed reporting guidelines.

Observational data provide invaluable real-world information in medicine, but certain methodological considerations are required to derive causal estimates. In this systematic review, we evaluated the methodology and reporting quality of individual-level patient data meta-analyses (IPD-MAs) conducted with non-randomized exposures, published in 2009, 2014, and 2019 that sought to estimate a causal relationship in medicine. We screened over 16,000 titles and abstracts, reviewed 45 full-text articles out of the 167 deemed potentially eligible, and included 29 into the analysis. Unfortunately, we found that causal methodologies were rarely implemented, and reporting was generally poor across studies. Specifically, only three of the 29 articles used quasi-experimental methods, and no study used G-methods to adjust for time-varying confounding. To address these issues, we propose stronger collaborations between physicians and methodologists to ensure that causal methodologies are properly implemented in IPD-MAs. In addition, we put forward a suggested checklist of reporting guidelines for IPD-MAs that utilize causal methods. This checklist could improve reporting thereby potentially enhancing the quality and trustworthiness of IPD-MAs, which can be considered one of the most valuable sources of evidence for health policy.

Adaptive designs were primarily used but inadequately reported in early phase drug trials.

BACKGROUND: Faced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive designs to speed up the development of new drugs. However, the application of adaptive design to drug randomized controlled trials (RCTs) and whether the reporting is adequate are unclear. Thus, this study aimed to summarize the epidemiological characteristics of the relevant trials and assess their reporting quality by the Adaptive designs CONSORT Extension (ACE) checklist. METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov from inception to January 2020. We included drug RCTs that explicitly claimed to be adaptive trials or used any type of adaptative design. We extracted the epidemiological characteristics of included studies to summarize their adaptive design application. We assessed the reporting quality of the trials by Adaptive designs CONSORT Extension (ACE) checklist. Univariable and multivariable linear regression models were used to the association of four prespecified factors with the quality of reporting. RESULTS: Our survey included 108 adaptive trials. We found that adaptive design has been increasingly applied over the years, and was commonly used in phase II trials (n = 45, 41.7%). The primary reasons for using adaptive design were to speed the trial and facilitate decision-making (n = 24, 22.2%), maximize the benefit of participants (n = 21, 19.4%), and reduce the total sample size (n = 15, 13.9%). Group sequential design (n = 63, 58.3%) was the most frequently applied method, followed by adaptive randomization design (n = 26, 24.1%), and adaptive dose-finding design (n = 24, 22.2%). The proportion of adherence to the ACE checklist of 26 topics ranged from 7.4 to 99.1%, with eight topics being adequately reported (i.e., level of adherence ≥ 80%), and eight others being poorly reported (i.e., level of adherence ≤ 30%). In addition, among the seven items specific for adaptive trials, three were poorly reported: accessibility to statistical analysis plan (n = 8, 7.4%), measures for confidentiality (n = 14, 13.0%), and assessments of similarity between interim stages (n = 25, 23.1%). The mean score of the ACE checklist was 13.9 (standard deviation [SD], 3.5) out of 26. According to our multivariable regression analysis, later published trials (estimated ß = 0.14, p < 0.01) and the multicenter trials (estimated ß = 2.22, p < 0.01) were associated with better reporting. CONCLUSION: Adaptive design has shown an increasing use over the years, and was primarily applied to early phase drug trials. However, the reporting quality of adaptive trials is suboptimal, and substantial efforts are needed to improve the reporting.

Validity and Reliability of the Turkish Version of Mild Behavioral Impairment Checklist in Patients With Cognitive Impairment.

BACKGROUND AND OBJECTIVE: The Mild Behavioral Impairment-Checklist (MBI-C) was developed to detect and standardize neuropsychiatric symptoms. The objective of this study was to evaluate the Turkish adaptation, validity, and reliability of the MBI-C. METHODS: The sample of our study consisted of 80 patients with cognitive impairment and a control group with 113 participants whose cognitive impairment was not detected in standard tests. Participants were evaluated with the Standardized Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Geriatric Depression Scale-15 (GDS-15), MBI-C and Neuropsychiatric Inventory (NPI). RESULTS AND CONCLUSION: In the reliability analysis, the Cronbach-alpha value for MBI-C was found to be .810. In the ROC analysis performed with the total MBI-C score, the area under the curve (AUC) was calculated as .821 and the cut-off score was determined as 8.5; sensitivity was calculated as .77 and specificity as .83. A strong positive correlation was found between test-retest MBI-C scores (r = .886, P < .0019). A strong positive correlation was found between MBI-C and NPI scores (r = .964, P < .001). MBI-C scores were significantly negatively correlated with MMSE and MoCA scores and positively correlated with GDS-15 scores. The results of our study showed that the Turkish version of the MBI-C is a valid and reliable measurement.

Interrater reliability of the violence risk assessment checklist for youth: a case vignette study.

BACKGROUND: Facilities providing health- and social services for youth are commonly faced with the need for assessment and management of violent behavior. These providers often experience shortage of resources, compromising the feasibility of conducting comprehensive violence risk assessments. The Violence Risk Assessment Checklist for Youth aged 12-18 (V-RISK-Y) is a 12-item violence risk screening instrument developed to rapidly identify youth at high risk for violent behavior in situations requiring expedient evaluation of violence risk. The V-RISK-Y instrument was piloted in acute psychiatric units for youth, yielding positive results of predictive validity. The aim of the present study was to assess the interrater reliability of V-RISK-Y in child and adolescent psychiatric units and acute child protective services institutions. METHODS: A case vignette study design was utilized to assess interrater reliability of V-RISK-Y. Staff at youth facilities (N = 163) in Norway and Sweden scored V-RISK-Y for three vignettes, and interrater reliability was assessed with the intraclass correlation coefficient (ICC). RESULTS: Results indicate good interrater reliability for the sum score and Low-Moderate-High risk level appraisal across staff from the different facilities and professions. For single items, interrater reliability ranged from poor to excellent. CONCLUSIONS: This study is an important step in establishing the psychometric properties of V-RISK-Y. Findings support the structured professional judgment tradition the instrument is based on, with high agreement on the overall risk assessment. This study had a case vignette design, and the next step is to assess the reliability and validity of V-RISK-Y in naturalistic settings.

What do meta-analysts need in primary studies? Guidelines and the SEMI checklist for facilitating cumulative knowledge.

Meta-analysis is often recognized as the highest level of evidence due to its notable advantages. Therefore, ensuring the precision of its findings is of utmost importance. Insufficient reporting in primary studies poses challenges for meta-analysts, hindering study identification, effect size estimation, and meta-regression analyses. This manuscript provides concise guidelines for the comprehensive reporting of qualitative and quantitative aspects in primary studies. Adhering to these guidelines may help researchers enhance the quality of their studies and increase their eligibility for inclusion in future research syntheses, thereby enhancing research synthesis quality. Recommendations include incorporating relevant terms in titles and abstracts to facilitate study retrieval and reporting sufficient data for effect size calculation. Additionally, a new checklist is introduced to help applied researchers thoroughly report various aspects of their studies.

Development and evaluation of a customized checklist to assess the quality control of disease registry systems of Tehran, the capital of Iran in 2021.

BACKGROUND: Clinical registries facilitate medical research by providing 'real data'. In the past decade, an increasing number of disease registry systems (DRS) have been initiated in Iran. Here, we assessed the quality control (QC) of the data recorded in the DRS established by Shahid Beheshti University of Medical Sciences in Tehran, the capital city of Iran, in 2021. METHODS: The present study was conducted in two consecutive qualitative and quantitative phases and employed a mixed-method design. A checklist containing 23 questions was developed based on a consensus reached following several panel group discussions, whose face content and construct validities were confirmed. Cronbach's alpha was calculated to verify the tool's internal consistency. Overall, the QC of 49 DRS was assessed in six dimensions, including completeness, timeliness, accessibility, validity, comparability, and interpretability. The seventy percent of the mean score was considered a cut-point for desirable domains. RESULTS: The total content validity index (CVI) was obtained as 0.79, which is a reasonable level. Cronbach's alpha coefficients obtained showed acceptable internal consistency for all of the six QC domains. The data recorded in the registries included different aspects of diagnosis/treatment (81.6%) and treatment quality requirements outcomes (12.2%). According to the acceptable quality cut-point, out of 49 evaluated registries, 48(98%), 46(94%), 41(84%), and 38(77.5%), fulfilled desirable quality scores in terms of interpretability, accessibility, completeness, and comparability, however, 36(73.5%) and 32(65.3%) of registries obtained the quality requirement for timeliness and validity, respectively. CONCLUSION: The checklist developed here, containing customized questions to assess six QC domains of DRSs, provided a valid and reliable tool that could be considered as a proof-of-concept for future investigations. The clinical data available in the studied DRSs fulfilled desirable levels in terms of interpretability, accessibility, comparability, and completeness; however, timeliness and validity of these registries needed to be improved.

Guidelines for clinical trials using artificial intelligence - SPIRIT-AI and CONSORT-AI†.

The rapidly growing use of artificial intelligence in pathology presents a challenge in terms of study reporting and methodology. The existing guidelines for the design (SPIRIT) and reporting (CONSORT) of clinical trials have been extended with the aim of ensuring production of the highest quality evidence in this field. We explore these new guidelines and their relevance and application to pathology as a specialty. © 2020 The Authors. The Journal of Pathology published by John Wiley & Sons, Ltd. on behalf of The Pathological Society of Great Britain and Ireland.

Validity and reliability of a checklist for patients with Behçet's disease based on the International Classification of Functioning, Disability and Health.

In 2020, we reported the "BD-checklist 92" for patients with Behçet's disease (BD) based on the International Classification of Functioning, Disability and Health. The purpose of the present study was to evaluate the validity and reliability of this checklist. Questionnaires using the "BD-checklist 92" and the 36-item Short Form Survey (SF-36) were sent to ten affiliated institutions. In total, 174 patients answered the questionnaire (response rate, 32.7%). Criterion validity was evaluated using the correlation coefficient between the number of problem categories extracted from the "BD-checklist 92" and the scores of the eight subscales and two components of the SF-36. Construct validity was assessed based on the number of problem categories extracted as an external criterion for the number of manifestations experienced and specific lesions. The comparison was performed using the Mann-Whitney U test. Cronbach's alpha coefficient was used to evaluate reliability. The number of problem categories in the "Body functions and structures", "Activities and participation", and "Environmental factors" components correlated significantly with all dimensions of the SF-36 questionnaire (P < 0.05 each). Construct validity showed that the number of manifestations experienced in all components (P < 0.001 each) and specific lesions in "Body functions and structures" and "All categories" (P = 0.002 and 0.050, respectively) contributed to an increased number of problems associated with BD. Cronbach's alpha coefficient for the "BD-checklist 92" was 0.926. This study confirmed the validity and reliability of the "BD-checklist 92".

Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension.

Importance: Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis. Objective: To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports. Findings: The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18). Conclusions and Relevance: This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

Sex omission and male bias are still widespread in cell experiments.

Integrating sex as an important biological variable is imperative to enhance the accuracy and reproducibility of cell-based studies, which provide basic information for subsequent preclinical and clinical study designs. Recently, international funding agencies and renowned journals have been attempting to integrate sex as a variable in every research step. To understand what progress has been made in reporting of cell sex in the articles published in AJP-Cell Physiology since the analysis in 2013, we examined the sex notation of the cells in relevant articles published in the same journal in 2018. Of the 107 articles reporting cell experiments, 53 reported the sex of the cells, 18 used both male and female cells, 23 used male cells only, and 12 used female cells only. Sex omission was more frequent when cell lines were used than when primary cells were used. In the articles describing experiments performed using rodent primary cells, more than half of the studies used only male cells. Our results showed an overall improvement in sex reporting for cells in AJP-Cell Physiology articles from 2013 (25%) to 2018 (50%). However, sex omission and male bias were often found still. Furthermore, the obtained results were rarely analyzed by sex even when both male and female cells were used in the experiments. To boost sex-considerate research implementation in basic biomedical studies, cooperative efforts of the research community, funders, and publishers are urged.

Compliance With Preferred Reporting Items for Systematic Review and Meta-Analysis Individual Participant Data Statement for Meta-Analyses Published for Stroke Studies.

Background and Purpose: Individual-participant data meta-analyses (IPD-MA) are powerful evidence synthesis studies which are considered the gold-standard of MA. The quality of reporting in these studies is guided by the 2015 Preferred Reporting Items for Systematic Review and Meta-Analysis of Individual Participant Data (PRISMA-IPD) guidelines. The growing number of IPD-MA published for stroke studies calls for an assessment of the compliance of these studies with the PRISMA-IPD statement. Methods: PubMed and EMBASE were searched for MA in stroke published between January 1, 2016, and March 30, 2020, in journals with impact factor >2. Literature reviews, scoping reviews, and aggregate MA were excluded. The final articles were scored using the 31-item PRISMA-IPD checklist. Results were depicted using descriptive statistics. Compliance with each item in PRISM-IPD guideline was recorded. The study was defined as compliant to IPD analyses if it satisfied all IPD specific items. Results: From an initial set of 321 articles, 31 met the final eligibility for data extraction. Only 4 (13%) described the use of PRISMA-IPD guidelines in their methodology, while 8/31 (26%) used the old PRISMA guidelines and 19/31 (61%) followed none. Regardless of mention of using IPD specific guidelines, 42% (n=13) of studies were compliant with all 4 IPD specific domains. The poorest areas of compliance were bias assessment within (32%) and across (39%) studies, reporting protocol and registration (42%), and reporting of IPD integrity (48%). The median journal impact factor was similar between the compliant (median, 8.1 [interquartile range, 5.4­39.9]) and noncompliant (median, 6 [interquartile range, 4.5­16.2]) groups (P=0.24). Similarly, the journal, country of correspondence, number of authors, number of studies included in MA, study sample size, and funding source were statistically similar between the groups. Conclusions: For the published IPD-MA stroke studies, the compliance with PRISMA-IPD statement and compliance with 4 IPD specific items was suboptimal. The journal, author, and study-related factors were not associated with compliance. Additional scrutiny measures to ensure adherence to mandated guidelines might increase the compliance. Several avenues to improve compliance and ensure optimal adherence are discussed.

Recommended reporting items for epidemic forecasting and prediction research: The EPIFORGE 2020 guidelines.

BACKGROUND: The importance of infectious disease epidemic forecasting and prediction research is underscored by decades of communicable disease outbreaks, including COVID-19. Unlike other fields of medical research, such as clinical trials and systematic reviews, no reporting guidelines exist for reporting epidemic forecasting and prediction research despite their utility. We therefore developed the EPIFORGE checklist, a guideline for standardized reporting of epidemic forecasting research. METHODS AND FINDINGS: We developed this checklist using a best-practice process for development of reporting guidelines, involving a Delphi process and broad consultation with an international panel of infectious disease modelers and model end users. The objectives of these guidelines are to improve the consistency, reproducibility, comparability, and quality of epidemic forecasting reporting. The guidelines are not designed to advise scientists on how to perform epidemic forecasting and prediction research, but rather to serve as a standard for reporting critical methodological details of such studies. CONCLUSIONS: These guidelines have been submitted to the EQUATOR network, in addition to hosting by other dedicated webpages to facilitate feedback and journal endorsement.

The IDEAL Reporting Guidelines: A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation.

OBJECTIVE: The aim of this study was to define reporting standards for IDEAL format studies. BACKGROUND: The IDEAL Framework and Recommendations establish an integrated pathway for evaluation of new surgical techniques and complex therapeutic technologies. However guidance on implementation has been incomplete, and incorrect use is commonly seen. We describe the consensus development of reporting guidelines for the IDEAL stages, and plans for their dissemination and evaluation. METHODS: Using the EQUATOR Network recommendations, participants with knowledge of IDEAL were surveyed to determine which IDEAL stages needed reporting guidelines. Draft checklists for stages 1, 2a, 2b, and 4 were subsequently developed by 3 researchers (N.B., A.H., P.M.), and revised through a 2-round Delphi consensus process. A final consensus teleconference resolved outstanding disagreements and clarified wording for checklist items. RESULTS: Sixty-one participants completed the initial survey, a clear majority indicating that new reporting guidelines were needed for IDEAL Stage 1 (69.5%), Stage 2a (78%), Stage 2b (74.6%), and Stage 4 (66%). A proposed set of checklists was modified by survey participants in 2 online Delphi rounds (n = 54 and n = 47, respectively), resulting in a penultimate checklist for each stage. Fourteen expert working group members finalized the checklist items and successfully resolved any outstanding areas without agreement on a consensus call. CONCLUSIONS: Participants familiar with IDEAL called for reporting guidelines for studies in all IDEAL stages except stage 3. The checklists developed have the potential to improve standards of reporting and thereby advance the quality of research on surgery and complex interventions and technologies, but require further evaluation in use.

Diabetes distress instruments in adults with Type 1 diabetes: A systematic review using the COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) checklist.

AIMS: To identify all extant instruments used to measure diabetes distress in adults with Type 1 diabetes and to evaluate the evidence for the measurement properties of these instruments. METHODS: Medline, Embase, CINAHL plus and PsycINFO were systematically searched from inception up until 12 March 2020 for all publications which evaluated the psychometric properties of diabetes distress measurement instruments. The quality of the methodology and the measurement properties in the identified studies were evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. RESULTS: Seven out of the 7656 articles retrieved in the search were included in the final review. Four diabetes distress measurement instruments were identified, none of which displayed evidence for all measurement properties specified in the COSMIN guidelines. The Problem Areas in Diabetes-11 (PAID-11) demonstrated the best psychometric properties, displaying strong evidence for structural validity, internal consistency, hypothesis testing, responsiveness and criterion validity. The Problem Areas in Diabetes scale (PAID) was the most frequently investigated instrument, demonstrating good relevance and hypothesis testing across four studies; however, concerns remain over its factor structure. CONCLUSION: The PAID-11 appears to be the most psychometrically sound instrument for measuring diabetes distress in adults with Type 1 diabetes, displaying strong evidence for a range of measurement properties. However, as only one study evaluated this instrument and its content validity has yet to be assessed, further validation is warranted. Additional qualitative work is needed to assess the content validity of these instruments among individuals with Type 1 diabetes.

The Impact of FASTPASS: A Collaboration With Emergency Department to Improve Management of Patients With Gallbladder Disease and Acute Appendicitis.

BACKGROUND: Efficient Emergency Department (ED) throughput depends on several factors, including collaboration and consultation with surgical services. The acute care surgery service (ACS) collaborated with ED to implement a new process termed "FASTPASS" (FP), which might improve patient-care for those with acute appendicitis and gallbladder disease. The aim of this study was to evaluate the 1-year outcome of FP. METHODS: FASTPASS is a joint collaboration between ACS and ED. ED physicians were provided with a simple check-list for diagnosing young males (<50-year old) with acute appendicitis (AA) and young males or females (<50-year old) with gallbladder disease (GBD). Once ED deemed patients fit our FP check-list, patients were directly admitted (FASTPASSed) to the observation unit. The ACS then came to evaluate the patients for possible surgical intervention. We performed outcome analysis before and after the institution of the FP. Outcomes of interest were ED length of stay (LOS), time from ED to the operating room (OR) (door-to-knife), hospital LOS (HLOS), and cost. RESULTS: During our 1-year study period, for those patients who underwent GBD/AA surgery, 56 (26%) GBD and 27 (26%) AA patients met FP criteria. Compared to the non-FP patients during FP period, FP halved ED LOS for GBD (7.4 ± 3.0 versus 3.5 ± 1.7 h, P < 0.001) and AA (6.7 ± 3.3 versus. 1.8 ± 1.6 h, P < 0.001). Similar outcome benefits were observed for door-to-knife time, HLOS, and costs. CONCLUSIONS: In this study, the FP process improved ED throughput in a single, highly-trained ER leading to an overall improved patient care process. A future study involving multiple EDs and different disease processes may help decrease ED overcrowding and improve healthcare system efficiency.