Non-significant Outcomes Research Articles

How statistically fragile are randomized controlled trials comparing quadriceps tendon autografts with hamstring or bone-patellar tendon-bone autografts in anterior cruciate ligament reconstruction?

To determine the statistical fragility of randomized controlled trials (RCTs) which compare the use of quadriceps tendon (QT) autografts to either hamstring tendon (HT) or bone-patellar tendon-bone (BPTB) autografts in anterior cruciate ligament reconstruction (ACLR). A search was conducted across PubMed, MEDLINE and EMBASE databases for RCTs comparing QT autografts to HT or BPTB autografts in ACLR from inception to 21 April 2024. Studies that reported ≥1 statistically significant continuous outcome, statistically significant dichotomous outcome and/or nonsignificant dichotomous outcome were included for analysis. The fragility index (FI), continuous fragility index (CFI) and reverse fragility index (RFI) were calculated for significant dichotomous outcomes, significant continuous outcomes and nonsignificant dichotomous outcomes, respectively. A total of 11 RCTs comprising 716 patients were included. The mean sample size was 65.8 patients. The median FI among nine outcomes from four studies was 1.0 (interquartile range [IQR], 0.5; 95% confidence interval [CI], 0.6-1.4; range 0.5-1.5). The number of patients lost to follow-up at the final follow-up period was more than the study-specific FI in three (75%) studies. The median CFI among 30 outcomes from six studies was 4.9 (IQR, 10.1, 95% CI, 3.9-8.2; range 0-18.2). The number of patients lost to follow-up at the final follow-up period was more than the study-specific CFI in four (66.7%) studies. The median RFI among 10 outcomes from five studies was 5.0 (IQR, 3.5; 95% CI, 3.4-6.6; range 1.0-9.0). The number of patients lost to follow-up at the final follow-up period was more than the study-specific RFI in four (80%) studies. This systematic review revealed that regardless of the metric used, RCTs comparing QT autografts to HT or BPTB autograft options in ACLR are statistically fragile. While the indices of statistical fragility evaluated in this study are important metrics of robustness to consider, their application in research and clinical practice needs to be further elucidated. Level I.

The Fragility of Statistical Significance in the Use of Aspirin in Prevention of Venous Thromboembolism Events Following Total Joint Arthroplasty: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background/Objectives: Comparative studies often use the p value to convey statistical significance, but fragility indices (FI) and fragility quotients (FQ) may better signify statistical strength. The use of aspirin as venous thromboembolism (VTE) chemoprophylaxis following elective arthroplasty has been debated between the orthopedic and cardiac fields. The purpose of this study was to apply both the FI and FQ to evaluate the degree of statistical fragility in the total joint arthroplasty (TJA) literature regarding aspirin (ASA) use for VTE prevention. Methods: We performed a systematic search for TJA clinical trials from 2004 to 2023 reporting comparisons between ASA and other chemoprophylaxis methods for VTE. The FI of each outcome was calculated through reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by study sample size and interquartile range (IQR) was calculated. SPSS Meta-analysis function was used to calculate the Mean Effect Size Estimate and 95% Confidence Intervals for each outcome. Results: Of 245 articles screened, 39 met search criteria, with 10 RCTs included for analysis (n = 11,481 patients). There were 38 outcome events reported, with three significant (p < 0.05) outcomes and 35 non-significant (p > 0.05) outcomes identified. The overall FI and FQ for all 38 outcomes were 6 (IQR: 5-7) and 0.059 (IQR: 0.044-0.064), respectively. Seven studies (70%) reported a loss-to-follow-up (LTF) greater than the overall FI. There was no increased risk of DVT, PE, or mortality with use of ASA (all p > 0.2). Conclusions: Despite showing non-inferiority in preventing venous thromboembolic events in TJA overall, the highest-level peer-reviewed literature concerning aspirin use following total joint arthroplasty is considered statistically fragile due to high loss-to-follow-up. In addition to the reporting of the p value, the fragility index and quotient can further provide insight into the strength and trustworthiness of outcome measures.

Evaluation of the robustness of randomized controlled trials for the treatment modalities of esophageal cancer using the fragility index - a systematic review.

Esophageal cancer remains a significant global health challenge. Several treatment modalities were explored in randomized controlled trials (RCTs) in recent decades. This study evaluates the robustness of RCTs focusing on esophageal cancer treatment using the fragility index (FI) and reverse fragility index (RFI). A systematic review of RCTs studying different treatment modalities for esophageal cancer from 2000 to 2023 was conducted. The FI and RFI were utilized to gauge the robustness of statistically significant and non-significant outcomes, respectively. The FI represents the minimal number of patient outcomes that would need to alter to overturn a trial's statistical significance, while RFI indicates the minimal changes required to achieve significance in non-significant results. Out of 4028 studies retrieved, 21 RCTs were included for final analysis. The studies spanned 2001 to 2023 with a mean followup of 66 months (range, 29-108 months) and median number of patients of 194 (range, 45-802). The most common treatment modalities examined in these studies were neoadjuvant chemoradiotherapy (n = 7, 33.3%), neoadjuvant chemotherapy (n = 4, 19.0%), and neoadjuvant immunotherapy (n = 2, 9.5%). Only 5 studies (23.8%) had a statistically significant primary outcome result with a median FI of 6 (IQR, 2.5-8.5). Non-significant primary outcomes were seen in 16 studies (76.2%) with a median RFI of 4 (IQR 1-11) and lost to followup of 0 (IQR 0-4). In the study with the highest FI (10), the FI was lower than the number of patients lost to followup (13). Our findings demonstrate that most RCTs on esophageal cancer treatments did not report significant primary outcomes. The few studies that reported significant results had a low fragility index, suggesting a vulnerability in their findings.

Fragility Index Analysis of the 2018 Clinical Practice Guidelines on Tranexamic Acid Use in Total Joint Arthroplasty

BackgroundThe 2018 American Association of Hip and Knee Surgeons clinical practice guideline (CPG) ‘tranexamic acid use in total joint arthroplasty’ evaluated the efficacy and safety of tranexamic acid in primary total joint arthroplasty. The following review assessed the statistical fragility of the randomized controlled trial (RCT) outcomes on which the CPG recommendations were based using a fragility analysis. MethodsAll dichotomous outcomes from the RCTs used to guide the CPG from its associated network, and direct meta-analyses were analyzed. Fragility and reverse fragility indices (FI and rFI) and quotients were calculated for each outcome. The mean indices and quotients were calculated for each guideline question, outcome category, and comparison of tranexamic dose, formulation, and administration timing. ResultsThis review evaluated 403 dichotomous outcomes on transfusion and complication rates associated with tranexamic acid (TXA) administration. The mean FI of significant outcomes of the CPG was 5.23, and the mean rFI of nonsignificant outcomes was 5.80. Outcomes assessing complication rates had a mean rFI of 6.48. Most outcomes on transfusion in categories comparing TXA to placebo administration had higher mean FIs than rFIs, and all outcomes comparing transfusion risk associated with different TXA formulations and doses had higher mean rFIs than FI or no associated significant outcomes. ConclusionsThe rFI and FIs calculated for this CPG are comparable to or higher than mean values reported across orthopaedic literature, indicating the relative statistical stability of its included outcomes. As we learn more about fragility analyses and their potential applications, this type of statistical analysis shows promise as a useful tool to incorporate into future guidelines to assess the quality of RCTs and evaluate the strength of recommendations.

Poster 346: The Statistical Fragility of Lateral Extra-articular Tenodesis Research: A Systematic Review

Objectives: With reinterest in lateral extra-articular tenodesis (LET), there is an imperative need to evaluate the rigor of clinical studies regarding LET with anterior cruciate ligament reconstruction (ACLR). This study aims to present a comprehensive picture of the robustness of evidence from comparative studies regarding LET and to inform evidence-based medical decision-making for current practitioners. We hypothesized that the results of these analyses will show statistical fragility, consistent with similar evidence across the orthopaedic literature. Methods: Using the PubMed database, comparative studies and randomized controlled trials (RCTs) related to LET as an augmentation procedure to ACLR or revision ACLR published between 2000 and 2022 were identified and collected. Studies on the topic were broadly queried for relevance, and after screening, they were included if they were (1) pertaining to LET as an augmentation to ACLR or revision ACLR, and (2) designed as comparative studies or RCTs. Exclusion criteria included (1) cadaveric, nonhuman, in vitro, laboratory, or surgical technique (without patient outcomes); (2) commentary, editorial, letter to the editor, conference reports, future study design/published protocol; (3) only abstract available; (4) non-English; or (5) lacked the statistical basis for a fragility analysis. Manuscripts were independently reviewed by three authors and variables of interest of interest were extracted, including both dichotomous and continuous variables relevant to clinical decision making. Discrepancies were resolved via paired discussions. For each dichotomous outcome, we calculated a Fragility Index (FI). FI was calculated using a 2-by-2 contingency table and the Fisher's exact test using the method outlined in Figure 1. For each continuous outcome, we calculated a Continuous Fragility Index (CFI). CFI was calculated using Welch's t-test and the method proposed by Caldwell et al to expand fragility analysis to continuous variables. The analysis for each outcome was conducted with n = 5 simulations using synthetic, representative data generated from the reported sample mean, standard deviation, and sample size for both the experimental and control arms. For both dichotomous and continuous outcomes, the statistical fragility was reported using median and interquartile range. Comparisons of mean statistical fragility were conducted using a nonparametric t test. Data were analyzed using Python 3.7. Results: Out of the 455 initially identified studies, 178 full texts were screened. Ultimately, 29 studies were included in the final analysis, including 20 comparative studies and 9 RCTs. 18 studies reported dichotomous outcomes and 27 studies reported continuous outcomes, which resulted in a cumulative total of 48 dichotomous outcomes and 265 continuous outcomes for analysis. Figure 4 reports the distribution of FI and CFI values for all dichotomous and continuous outcomes. The median FI was 9.0 (25-75th percentile, 7.0-13.25). The median CFI was 7.8 (25-75th percentile, 4.2-19.6). Commonly reported dichotomous outcomes included clinical failure, graft rupture, and return to sport. The number of outcomes in which loss to follow-up (LTF) exceeded the FI was 13 (27%). Reported significant dichotomous outcomes were significantly more fragile than outcomes that were not significant (fragility quotient [FQ] = 0.02 vs 0.11, Welch t test p &lt; 0.001); however, most dichotomous outcomes were reported insignificant (79.2%) (Table 1). Commonly reported continuous outcomes across different studies included KOOS, IKDC, and Lysholm scores. LTF exceeded the CFI for 20 outcomes (8%). In contrast to dichotomous outcomes, continuous outcomes from RCTs and comparative studies were equivalently robust (continuous fragility quotient [CFQ] = 0.12 vs 0.12). The CFQ of both significant and nonsignificant continuous outcomes were similarly equal (0.12 vs 0.12) (Table 2). Reports on fragility quotients from studies that focused on LET for either primary or revision ACLR clinically are presented in Table 3. These subgroups excluded translational research and imaging studies. The FQ and CFQ for studies focused on revision ACLR were larger (0.117 and 0.113) than those focused on primary ACLR (0.042 and 0.095). Conclusions: Research regarding the usage of LET as an augmentation procedure for ACLR and revision ACLR is more statistically robust than many other topics within orthopaedics. Studies regarding LET with primary ACLR are more fragile than those for revision ACLR. Given the resurgent interest in this procedure and the current mixed evidence regarding its effectiveness and indications, we recommend the future reporting of fragility quotients alongside p-values, to assist clinicians in assessing the robustness of new evidence to inform decision making.

The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials

PurposeThis study employs both the fragility index (FI) and fragility quotient (FQ) to assess the level of robustness in the cervical disc arthroplasty (CDA) literature. We hypothesize that dichotomous outcomes involving CDA would exhibit statistical vulnerability.MethodsA PubMed search was conducted to evaluate dichotomous data for randomized controlled trials (RCTs) in CDA literature from 2000 to 2023. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the study sample size. The interquartile range (IQR) was also calculated for the FI and FQ.ResultsOf the 1561 articles screened, 111 met the search criteria, with 35 RCTs evaluating CDA included for analysis. Six hundred and ninety-three outcome events with 130 significant (P < 0.05) outcomes and 563 nonsignificant (P ≥ 0.05) outcomes were identified. The overall FI and FQ for all 693 outcomes were 5 (IQR 3–7) and 0.019 (IQR 0.011–0.043). Fragility analysis of statistically significant outcomes and nonsignificant outcomes both revealed an FI of 5. All of the studies reported loss to follow-up (LTF) data where 65.7% (23) did not report or reported an LTF greater or equal to 5.ConclusionsThe literature regarding CDA RCTs lacks statistical robustness and may misrepresent the conclusions with the sole use of the P value. By implementing the FI and FQ along with the P value, we believe the interpretation and contextualization of the clinical data surrounding CDA will be better understood.

Outcome-Reporting Bias in Special Education Intervention Research Using Experimental and Quasi-Experimental Group Designs: A Conceptual Replication

We conducted a conceptual replication of Pigott et al.’s study of outcome-reporting bias, wherein they compared intervention outcomes reported in unpublished education dissertations with corresponding published versions. For our replication, we identified a sample of 40 special education dissertations with matched journal publications and found that statistically significant intervention outcomes from dissertations were 1.48 times more likely to be published compared with nonsignificant outcomes. Significant moderators of this effect included type of intervention outcome (academic), type of research design (randomized controlled trial), participant race (with samples greater than or equal to 50% non-White), and type of disability/exceptionality (high incidence). We found that few dissertation authors published their work, providing further evidence for the much-needed inclusion of dissertations in systematic reviews.

Causal effects of PM2.5 exposure on neuropsychiatric disorders and the mediation via gut microbiota: A Mendelian randomization study

BackgroundGrowing evidence has revealed the impacts of exposure to fine particulate matter (PM2.5) and dysbiosis of gut microbiota on neuropsychiatric disorders, but the causal inference remains controversial due to residual confounders in observational studies. MethodsThis study aimed to examine the causal effects of exposure to PM2.5 on 4 major neuropsychiatric disorders (number of cases = 18,381 for autism spectrum disorder [ASD], 38,691 for attention deficit hyperactivity disorder [ADHD], 67,390 for schizophrenia, and 21,982 cases for Alzheimer’s disease [AD]), and the mediation pathway through gut microbiota. Two-sample Mendelian randomization (MR) analyses were performed, in which genetic instruments were identified from genome-wide association studies (GWASs). The included GWASs were available from (1) MRC Integrative Epidemiology Unit (MRC-IEU) for PM2.5, PMcoarse, PM10, and NOX; (2) the Psychiatric Genomics Consortium (PGC) for ASD, ADHD, and schizophrenia; (3) MRC-IEU for AD; and (4) MiBioGen for gut microbiota. Multivariable MR analyses were conducted to adjust for exposure to NOX, PMcoarse, and PM10. We also examined the mediation effects of gut microbiota in the associations between PM2.5 exposure levels and neuropsychiatric disorders, using two-step MR analyses. ResultsEach 1 standard deviation (1.06 ug/m3) increment in PM2.5 concentrations was associated with elevated risk of ASD (odds ratio [OR] 1.42, 95% confidence interval [CI] 1.00–2.02), ADHD (1.51, 1.15–1.98), schizophrenia (1.47, 1.15–1.87), and AD (1.57, 1.16–2.12). For all the 4 neurodevelopmental disorders, the results were robust under various sensitivity analyses, while the MR-Egger method yielded non-significant outcomes. The associations remained significant for all the 4 neuropsychiatric disorders after adjusting for PMcoarse, while non-significant after adjusting for NOX and PM10. The effects of PM2.5 exposure on ADHD and schizophrenia were partially mediated by Lachnospiraceae and Barnesiella, with the proportions ranging from 8.31% to 15.77%. ConclusionsThis study suggested that exposure to PM2.5 would increase the risk of neuropsychiatric disorders, partially by influencing the profile of gut microbiota. Comprehensive regulations on air pollutants are needed to help prevent neuropsychiatric disorders.

Patient flow in emergency departments: a comprehensive umbrella review of solutions and challenges across the health system

BackgroundGlobally, emergency departments (EDs) are overcrowded and unable to meet an ever-increasing demand for care. The aim of this study is to comprehensively review and synthesise literature on potential solutions and challenges throughout the entire health system, focusing on ED patient flow.MethodsAn umbrella review was conducted to comprehensively summarise and synthesise the available evidence from multiple research syntheses. A comprehensive search strategy was employed in four databases alongside government or organisational websites in March 2023. Gray literature and reports were also searched. Quality was assessed using the JBI critical appraisal checklist for systematic reviews and research syntheses. We summarised and classified findings using qualitative synthesis, the Population-Capacity-Process (PCP) model, and the input/throughput/output (I/T/O) model of ED patient flow and synthesised intervention outcomes based on the Quadruple Aim framework.ResultsThe search strategy yielded 1263 articles, of which 39 were included in the umbrella review. Patient flow interventions were categorised into human factors, management-organisation interventions, and infrastructure and mapped to the relevant component of the patient journey from pre-ED to post-ED interventions. Most interventions had mixed or quadruple nonsignificant outcomes. The majority of interventions for enhancing ED patient flow were primarily related to the 'within-ED' phase of the patient journey. Fewer interventions were identified for the 'post-ED' phase (acute inpatient transfer, subacute inpatient transfer, hospital at home, discharge home, or residential care) and the 'pre-ED' phase. The intervention outcomes were aligned with the aim (QAIM), which aims to improve patient care experience, enhance population health, optimise efficiency, and enhance staff satisfaction.ConclusionsThis study found that there was a wide range of interventions used to address patient flow, but the effectiveness of these interventions varied, and most interventions were focused on the ED. Interventions for the remainder of the patient journey were largely neglected. The metrics reported were mainly focused on efficiency measures rather than addressing all quadrants of the quadruple aim. Further research is needed to investigate and enhance the effectiveness of interventions outside the ED in improving ED patient flow. It is essential to develop interventions that relate to all three phases of patient flow: pre-ED, within-ED, and post-ED.

The Fragility of Statistical Findings in the Femoral Neck Fracture Literature: A Systematic Review of Randomized Controlled Trials.

Randomized controlled trials (RCTs) in the femoral neck fracture literature frequently report P -values for outcomes, which have substantial implications in guiding surgical management. This study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the statistical stability of outcomes reported in RCTs evaluating the management and treatment of femoral neck fractures. PubMed, Embase, and MEDLINE were queried for RCTs (January 1, 2010 to February 28, 2023). RCTs that evaluated surgical management or treatment of femoral neck fractures were included. RCTs with 2 treatment arms reporting categorical dichotomous outcomes were included. Non-RCT studies, RCTs with greater than 2 treatment arms, and RCTs without a femoral neck fracture cohort were excluded. The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant ( P < 0.05) and nonsignificant ( P ≥ 0.05) outcomes, respectively. The FQ was calculated by dividing the FI by the sample size for the study. Nine hundred eighty-five articles were screened, with 71 studies included for analysis. The median FI across a total of 197 outcomes was 4 [interquartile range (IQR) 2-5] with an associated FQ of 0.033 (IQR 0.017-0.060). Forty-seven outcomes were statistically significant with a median FI of 2 (IQR 1-4) and associated FQ of 0.02 (IQR 0.014-0.043). One hundred fifty outcomes were statistically nonsignificant with a median rFI of 4 (IQR 3-5) and associated FQ of 0.037 (IQR 0.019-0.065). Statistical findings in femoral neck fracture RCTs are fragile, with reversal of a median 4 outcomes altering significance of study findings. The authors thus recommend standardized reporting of P -values with FI and FQ metrics to aid in interpreting the robustness of outcomes in femoral neck fracture RCTs. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Can prolonged P-R interval predict clinical outcomes in non-ST elevation acute coronary syndrome patients?

BackgroundThe present study aimed to respond to clinical question, can prolonged P-R interval predict clinical outcomes in non-ST elevation acute coronary syndrome patients?MethodsThis descriptive-analytical study was conducted on cardiac patients. All of the non-ST elevation acute coronary syndrome (NSTEACS) including non-ST elevation myocardial infarction (NSTEMI) and unstable angina patients included in the study. Then they divided into two groups: prolonged P-R interval and normal P-R interval. The patients who had a history of digoxin and calcium channel blocker use, using antiarrhythmic drugs, known valvular or congenital heart disease and connective tissue, unreadable P-R interval and cardiac block were excluded. Data were collected using the questionnaire consisted demographic data and clinical outcomes and a follow-up part was completed by one of the researchers.ResultsFinally, 248 patients completed the study. The results showed both of the two groups had significant differences in terms of the history of myocardial infarction (MI) (p = 0.018), the level of high-density lipoprotein (HDL) (p = 0.004), heart rate (p = 0.042), inverted T wave (p = 0.017), anterior ST- segment depression (p = 0.008), normal report of coronary angiography (CAG) (p = 0.003), three vessels disease (p = 0.043), left main lesion (p = 0.045) and SYNTAX score (p = 0.032) based on the CAG report. The results of six-month follow-up showed although, the frequency of ischemic stroke, coronary artery disease (CAD) and cardiovascular death were higher in prolonged P-R interval groups. The chi-square test showed this difference was statistically non-significant (p > 0.05). The multivariate logistic regression model revealed non-significant relationships between prolonged P-R interval and SYNTAX score, significant CAD, three-vessel disease, inverted T wave, anterior ST depression, heart rate and HDL.ConclusionsBased on the results of our study the six-month follow-up showed non-significant outcomes. Further studies are recommended to assess the long-term outcomes.

The Statistical Fragility of Marrow Stimulation for Cartilage Defects of the Knee: A Systematic Review of Randomized Controlled Trials.

Marrow stimulation is used to address knee cartilage defects. In this study, we used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate statistical fragility of outcomes reported in randomized controlled trials (RCTs) evaluating marrow stimulation. PubMed, Embase, and MEDLINE were queried for recent RCTs (January 1, 2010-September 5, 2023) assessing marrow stimulation for cartilage defects of the knee. The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI by the study sample size. Across 155 total outcomes from 21 RCTs, the median FI was 3 (interquartile range [IQR], 2-5), with an associated median FQ of 0.067 (IQR, 0.033-0.010). Thirty-two outcomes were statistically significant, with a median FI of 2 (IQR, 1-3.25) and FQ of 0.050 (IQR, 0.025-0.069). Ten of the 32 (31.3%) outcomes reported as statistically significant had an FI of 1. In total, 123 outcomes were nonsignificant, with a median rFI of 3 (IQR, 2-5). Studies assessing stem cell augments were the most fragile, with a median FI of 2. In 55.5% of outcomes, the number of patients lost to follow-up was greater than or equal to the FI. Statistical findings in RCTs evaluating marrow stimulation for cartilage defects of the knee are statistically fragile. We recommend combined reporting of P-values with FI and FQ metrics to aid in the interpretation of clinical findings in comparative trials assessing cartilage restoration.

Statistical fragility of outcomes in acellular dermal matrix literature: A systematic review of randomized controlled trials

BackgroundAcellular dermal matrix (ADM) is commonly utilized in plastic and reconstructive surgery (PRS). With the abundance of randomized controlled trials (RCTs) reporting P-values for ADM outcomes, this study uses the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of outcomes in ADM RCTs. MethodsPubMed, Embase, SCOPUS, Medline, and Cochrane databases were reviewed for ADM RCTs (2003-present) reporting a dichotomous, categorical outcome. FI and rFI (event reversals influencing outcome significance) and FQ (standardized fragility) were calculated and reported as median (IQR). Subgroup analysis was performed based on intervention types. ResultsOut of 127 studies screened, 56 RCTs with 579 outcomes were included. The median FI stood at 4 (3 - 5) and FQ was 0.04 (0.03 - 0.07). Only 101 outcomes were statistically significant with a median FI of 3 (1 - 6) and FQ of 0.04 (0.02 - 0.08). The nonsignificant outcomes had a median FI of 4 (3 - 5) and FQ of 0.04 (0.03 - 0.07). Notably, 26% of outcomes had a number of patients lost to follow up equal to or surpassing the FI. By intervention type, the median FIs showed minor fluctuations but remained low. ConclusionsOutcomes from ADM-related RCTs are statistically fragile. Slight outcome reversals or maintaining patient follow-up can alter the significance of results. Therefore, future researchers are recommended to jointly report FI, FQ, and P-values to offer a comprehensive view of the robustness in ADM literature.

Misreporting study results in main texts and abstracts of randomized controlled trials published by physical therapy researchers (SPIN)

BACKGROUND: The distortion of truth or “spin” has become a major concern in various fields as it can affect the accuracy of research dissemination. Recognizing the extent of this issue in physiotherapy research is essential for promoting good-quality research and raising awareness. OBJECTIVE: This study aimed to determine the prevalence of spin in randomized controlled trials (RCTs) published by Indian physiotherapists. METHODS: A Medline search was conducted to identify RCTs published by Indian physiotherapists from January 2000 to November 2018. We included studies with nonsignificant primary outcomes and reviewed them for spin in both abstracts and full texts using the Boutron checklist. Three reviewers were involved in the process. RESULTS: Of the 44 RCTs with nonsignificant outcomes, 40 (90%) showed spin in their abstracts and 39 (88%) in their main text conclusions. CONCLUSIONS: Our findings reveal a significant prevalence of spin in nonsignificant RCTs published by physiotherapy researchers. Improving research knowledge, enhancing scientific writing skills, and providing mentorship may help reduce spin in result reporting.

Under Pressure? A Study of Heart Rate and Heart-Rate Variability Using SmarTerp

The results of a quasi-experimental, intra-subject study are reported on the effects of the use of SmarTerp on physiological stress levels of twelve second-year students of the MA in Interpreting at the University of Bologna during a simultaneous interpreting task. The study, part of a broader project, explores the rendition of terminological units, proper names, and numbers and its correlation with stress levels, to provide insights into SmarTerp’s practical usefulness in the field. Physiological stress levels were measured through heart rate and heart-rate variability indicators with Empatica E4 wristbands. Participants took part in three data-collection sessions over a month. In sessions 1 and 3 the participants interpreted two speeches, one with SmarTerp and another one without it. Descriptive findings hinted at a potential stress-alleviating effect of interpreting with SmarTerp, especially when interpreting into a second language. However, all inferential statistical results consistently revealed non-significant outcomes. Furthermore, stress levels did not decrease significantly over time when using SmarTerp. While the non-significant reduction in stress may cast doubt on the tool’s efficacy, the complexity and multiple variables influencing stress in interpreting tasks should be factored in. SmarTerp may serve its primary purpose in aiding accurate rendition of terminological units, proper names, and numbers.

Comparison of Frequentist and Bayesian Statistics for Studying Unconscious Perception: Differences Between Null Awareness Dissociation and Relative Sensitivity Dissociation.

For unconscious perception research, Bayesian statistics are more appropriate for assessing null awareness of masked stimuli than traditional (frequentist) statistics. This assertion is based mostly upon the theoretical features of Bayesian statistics and modeling studies. To further assess the potential advantages, we compared frequentist and Bayesian statistical tests in a masked Stroop priming experiment in which the prime stimuli were presented at varying degrees of visibility. A novel contribution was to compare a null awareness dissociation approach (i.e., stimulus awareness = 0) to a relative sensitivity approach (indirect or priming effects > direct effects) for the same data. From a null awareness perspective, the frequentist t-tests for the Stroop effect (i.e., perception) for the briefest display conditions had non-significant outcomes. Similar Bayesian t-tests were inconclusive. In contrast, the relative sensitivity dissociation approach was more interpretable, with strong evidence against unconscious perception from a single Bayesian t test. For the longer display conditions, both statistical approaches suggested large conscious perception effects. We conclude that the utility of Bayesian statistics is highly dependent upon the type of dissociation approach, with a relative sensitivity approach being more straightforward to interpret than a null awareness approach.

A Randomized, Single-Blind Study Comparing the Clinical Equivalence of Truglyde Fast® and Safil Quick® Polyglycolic Acid Fast-Absorbing Sutures for Episiotomy Repair Following Vaginal Delivery.

Episiotomy, the deliberate surgical incision on the vaginal orifice during vaginal delivery, requires prompt repairing of the incised tissue. It may be associated with bleeding, infection, dehiscence, dyspareunia, short-term pain, and prolonged hospital stay. The outcome of surgery depends on the suture material and technique to repair the episiotomy. We aim to subjectively assess perineal pain and maternal morbidity following episiotomy repair with Truglyde Fast®(Healthium Medtech Limited, Bengaluru, India) and Safil Quick® (B. Braun Medical Private Limited, Mumbai, India)polyglycolic acid fast-absorbing suture. This multicentric, prospective, randomized (1:1), two-arm, parallel-group, single-blind study was started in August 2020 and completed in March 2021. Ninety-nine primiparous or multiparous eligible women requiring episiotomy were recruited to Truglyde Fast® (n=51) and Safil Quick® (n=48) groups. The primary outcome measure was post-episiotomy perineal pain to be assessed using a visual analog scale (VAS). Secondary endpoints included evaluation of local anesthesia (quantity), intraoperative suture handling, number of sutures utilized, time spent for episiotomy repair and complete healing, analgesic number and dosage, early and late wound complications, presence of residual suture and frequency of re-suturing, resumption of sexual activity and dyspareunia, and adverse events. The threshold to discriminate significant from non-significant outcomes was p<0.05. At all visits, a non-significant change in perineal pain was noted between Truglyde Fast® and Safil Quick® groups. A significant difference (p<0.05) in the number of sutures used and intraoperative handling characteristics was observed between thegroups. Results of other secondary endpoints showed non-significant differences. Truglyde Fast® and Safil Quick® polyglycolic acid fast-absorbing sutures are clinically equivalent. Both sutures are safe and effective for episiotomy repair following vaginal delivery with minimal perineal pain and risk of maternal morbidity.

P-652 RCT to evaluate the necessity of routine luteal phase support after ovarian stimulation by oral ovulogens in intrauterine insemination (IUI) cycles

Abstract Study question 1. Is it beneficial to provide luteal phase support in each IUI cycle stimulated by oral ovulogens ? Summary answer 1. Luteal phase support with progesterone makes no significant difference in clinical pregnancy rate in oral ovulogen stimulated IUI cycles. What is known already ART (assisted reproductive techniques) involves superovulation to achieve the development of multiple follicles. This produces supraphysiological E2 levels that causes feedback inhibition of FSH and LH in luteal phase leading to luteal phase defect. In IUI,only few follicles develop ,so the above phenomenon is rarely seen. Today widespread use of progesterone in clinical practice has become a habit, instead of the need, adding to burden of medication and cost to the patient without much evidence to recommend it. Study design, size, duration Prospective Randomized control over 1 year 200 IUI cycles randomized to either supplementing luteal phase with tab dydrogesterone (Group A ,no.100) or not supplementing (Group B, No. 100) as per inclusion(Unexplained infertility,Mild male factor,Donor sperm IUI, PCOD,Coital factors,Mild endometriosis) and exclusion criteria(IUI with gonatotropin, age more than 38 years, thin endometrium ,previous two or more IUI failures, history suggestive of luteal phase defect, recurrent pregnancy loss, structural uterine anomaly, history of endocrine or autoimmune diseases) Participants/materials, setting, methods Transvaginal scan was conducted on day 2 , followed by ovarian stimulation with letrozole 2.5 mg for 5 days. HCG trigger (10000IU) was given When follicle reached 18- 24mm with endometrium &amp;gt;7mm and IUI timed 36 hours after. Computer generated random allocation was done with one group receiving luteal phase support with tab dydrogesterone 10mg twice a day(Group A)and other not receiving LPS(Group B).Outcome of study was studied in terms of clinical pregnancy on USG. Main results and the role of chance Among the patients recruited, infertility was observed to be primary infertility in 74% cases in Group B and 72% in Group A , whereas secondary infertility was observed in 26% cases in group B and 28% in group A (P = 0.75). Group B included mild male factor in 29%, 24% of polycystic ovarian syndrome, 17 % tubal, 15% poor ovarian reserve, 9% of unexplained and 6% had endometriosis. Whereas in group A, PCOS (25%),male factor (21%),poor ovarian reserve and unexplained in 20%, endometriosis in 8% and 6% had tubal infertility. Among patients, mean endometrium thickness on trigger day of group Band group A were 8.46 ± 1.36mm and 8.44 ± 1.17mm respectively. Conception was reported by a positive urine pregnancy test . Among Group B , 23% had a positive urine pregnancy test. Whereas, in controls Group A 21% had a positive test, the difference being statistically non-significant (p value = 0.733) Outcomes were expressed terms of clinical pregnancy described as the presence of intrauterine sac with foetal heart rate. Clinical pregnancy rate was 22% of group B and 21% in group A , difference was statistically nonsignificant (p = 0.755). Limitations, reasons for caution Due to limited period of study and hence restricted sample size, the trial needs to be extended over a larger sample size for further interpretation. Further subgroup analysis needs to be conducted when a larger study group is recruited. Wider implications of the findings This study suggested that luteal support does not significantly affect the clinical pregnancy rate in IUI cycles with oral ovulogens .Our study could be a basis for further analysis to determine whether treatment burden in the form of luteal phase support can be reduced in such patients. Trial registration number not applicable

A systematic review and meta-analysis of nonpharmacological interventions for children and adolescents with selective mutism.

Selective mutism (SM) is an anxiety disorder that often starts in early years with serious and lasting consequences. Nonpharmacological interventions are commonly seen as the preferred first treatment. This systematic review identifies outcome measures used and outcomes achieved for nonpharmacological interventions for children and adolescents with SM. Systematic searches were conducted using 13 electronic databases and hand searches, including peer-reviewed and grey literature since 1992. Twenty-five studies were identified. While specific measures varied, all studies reported an outcome measure for speaking behaviour and 18 used a measure of anxiety. Few studies reported measures of SM remission (k=6), well-being (k=6), academic impact (k=2), or quality of life (k=1). Within subject outcomes for nonpharmacological interventions were variable for improvements in speaking behaviours (very small to large positive effects) and reduction in anxiety symptoms (very small negative to large positive effects). Only five randomised controlled trials (RCTs) were included in the meta-analysis. Three studies compared a combined systems/behavioural approach with waitlist controls indicating a significant and large effect (Hedges g=1.06, p<.0001, 95% CI: 0.57-1.56) on improved speaking behaviour. Two of these RCTs showed a large effect for SM remission favouring the intervention (Risk Ratio=4.25, p=.1774, 95% CI: 0.52-34.84) but this did not reach statistical significance. Non-significant outcomes for two RCTs with active controls (Hedges g=0.55, p<.2885, 95% CI: -0.47 to 1.57) showed considerable heterogeneity in approach and outcomes, one with large and one with negligible effects. Despite the considerable impairment caused by SM, there has been little systematic evaluation of non-pharmacological interventions. Although combined systems/behavioural interventions are promising, further systematic evaluations are urgently needed to inform treatment approaches. Cross-study measurement harmonisation is required to promote learning from all studies, including wider clinical and economic outcomes. Not applicable.

The statistical fragility of the distal fibula fracture literature: A systematic review of randomized controlled trials

BackgroundThe purpose of this study was to apply both the fragility index (FI) and fragility quotient (FQ) to evaluate the degree of statistical fragility in the distal fibular fracture (DFF) literature. We hypothesized that the dichotomous outcomes within the DFF literature are statistically fragile. MethodsWe performed a PubMed search for distal fibular fractures clinical trials from 2000 to 2022 reporting dichotomous outcomes. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. ResultsOf the 1158 articles screened, 23 met the search criteria, with six RCTs included for analysis. Forty-five outcome events with 5 significant (p < 0.05) outcomes and 40 nonsignificant (p ≥ 0.05) outcomes were identified. The overall FI and FQ was 5 (IQR 4–6) and 0.089 (IQR 0.061–0.107), respectively. ConclusionsThe randomized controlled trials in the peer-reviewed distal fibular fracture literature may not be as robust as previously thought, as incorporating statistical analyses solely on a P value threshold is misleading. Standardized reporting of the P value, FI and FQ can help the clinician reliably draw conclusions based on the fragility of outcome measures.