Use of person-centred language among scientific research focused on childhood obesity.

BACKGROUND: Stigma towards children with obesity can begin as early as 3 years old, leading to increased risk for poorer mental health outcomes and lower quality of life. This includes discriminatory language used by peers and adults, which may be compounded by use within the medical community and in published research. OBJECTIVES: Our primary objective was to investigate adherence to person-centred language (PCL) in childhood obesity-related medical publications. METHODS: We searched PubMed for childhood obesity-related articles from 2018 through 2020, from journals frequently publishing childhood-obesity-related research. Articles were randomized and searched for a list of predetermined, stigmatizing terms. RESULTS: Of the sample of 300 articles, only 21.7% were adherent to PCL guidelines. The most frequent labels found were 'obese' appearing in 70.33% of articles and 'overweight' in 63.7%. Labels such as 'chubby', 'large', and 'fat' were less common, but still appeared in the medical literature. CONCLUSIONS: A majority of childhood obesity-related articles did not adhere to PCL guidelines. Given the negative effects of stigma among children with obesity, it is imperative to advocate for PCL use within the medical community. Increased stringency by journal editors and publishers may be the next step in this process.

Evaluation of the Completeness of Interventions Reported in Published Randomized Controlled Trials in Plastic Surgery: A Systematic Review.

BACKGROUND: With the increasing number of randomized control trials being conducted and published in plastic surgery, complete reporting of trial information is critical for readers to properly evaluate a trial's methodology and arrive at appropriate conclusions about its merits and applicability to patients. The Template for Intervention Description and Replication (TIDieR) checklist was introduced to address the limited guidance for reporting trial interventions. OBJECTIVES: The authors applied the TIDieR checklist to evaluate the completeness of intervention reporting of randomized control trials in plastic surgery, compare the quality of intervention reporting before and after the guideline was published, and evaluate characteristics associated with TIDieR compliance. METHODS: A PubMed search identified 1 cohort published prior to the release of TIDieR and another published after its release. From the final sample, the TIDieR checklist was applied to intervention descriptions, and relevant study characteristics were extracted in a duplicate, blinded manner. RESULTS: In total, 130 trials were included for analysis. The mean TIDieR score was 6.4 of 12. Five items were reported 90% of the time, and 4 items were reported less than 10% of the time. We found that TIDieR publication did not affect intervention reporting (P = 0.22). CONCLUSIONS: Our study identified areas in which intervention reporting could be improved. The extent of TIDieR adoption by trialists appears to be limited, and greater efforts are needed to disseminate this reporting guideline if widespread uptake is to be expected. Alternately, it may be beneficial to incorporate TIDieR into the more widely recognized Consolidated Standards of Reporting Trials statement.

The Potential Effect of Lowering the Threshold of Statistical Significance From P < .05 to P < .005 in Orthopaedic Sports Medicine.

PURPOSE: To determine how changing the P value threshold of statistical significance from .05 to .005 could affect the statistical significance of findings in previously published orthopaedic sports medicine randomized controlled trials (RCTs). METHODS: The authors searched PubMed from January 1, 2016, to December 31, 2017, for RCTs published in the American Journal of Sports Medicine, Arthroscopy, and Knee Surgery, Sports Traumatology, Arthroscopy. Data were extracted blinded and in duplicate fashion by 2 of us. The authors then extracted P value data for primary end points, since RCTs are most often powered for these end points. Discrepancies were resolved by consensus. Google Forms were used for data extraction and STATA 15.1 for the data analysis. RESULTS: In total, 275 primary end points were identified from 132 trials. Analysis of primary end points found 45.8% (126/275) had a P value less than .05 and were classified as statistically significant under the current threshold, whereas 54.2% (149/275) had a P value greater than .05 and were not classified as suggestive. Of those end points that were previously considered statistically significant, 38.9% (49/126) were less than .005, whereas 61.1% (77/126) were between .005 and .05 and thereby would be reclassified as suggestive rather than statistically significant under the proposed threshold. Overall, when analyzing the 275 primary end points, we found only 49 (17.8%) of the end points were less than .005 and would hold statistical significance with the proposed threshold. CONCLUSIONS: The results suggest that if the threshold of statistical significance were to change to .005, the significance of orthopaedic sports medicine RCTs would be heavily altered. The authors also acknowledge the many issues research faces in regard to P value reliability and therefore interpretation of study results. Because P values from RCTs can often influence the ways physicians choose interventions, it is important to implement methodology that decreases incidence of bias and misrepresentation of these results. However, the authors also understand that lowering the P value could increase the needed sample size and by consequence increase study costs as well, while not directly correlating to clinical significance. Thus, the authors recommend that this proposed threshold should be further evaluated and cautiously interpreted. CLINICAL RELEVANCE: If the statistical significance threshold is changed, clinical practice guideline recommendations also may be affected.

Evaluation of the completeness of interventions reported in published randomized controlled trials in plastic surgery: A cross-sectional review protocol.

BACKGROUND: Randomized controlled trials (RCTs) are critical in developing new therapeutic approaches. Historically, in plastic surgery, RCTs are uncommon as they make up less than 2% of all publications. However there has recently been an increase in RCTs appearing in plastic surgery but the quality of these articles has yet to be assessed. We aim to determine the completeness of intervention reporting in plastic surgery RCTs using the TIDieR checklist. METHODS: A search of Pubmed for RCTs published in the top 10 plastic surgery journals as determined by the Google h5-index will be performed by two investigators. All identified articles will be isolated and a random selection of 300 articles will be screened for inclusion in the study by two different investigators. All types of RCTs will be included in this study. Articles will be excluded if they are nonrandomized, observational, follow-up studies, or secondary analyses. Full exclusion criteria can be found within this protocol. Extracted data includes all 12 points of the TIDieR checklist, journal, intervention type, sample size, and funding source. A complete list of what data will be extracted is listed within this protocol. All data extraction will be performed by two independent investigators. All work will be verified by the two investigators and any discrepancies will be resolved via consensus between investigators or with third party adjudication. DISSEMINATION: We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.

The use of systematic reviews to justify phase III ophthalmology trials: an analysis.

BACKGROUND/OBJECTIVE: Given the drastic increase in publication output in recent years, minimizing research waste should be a top priority. There are established areas of concern regarding research waste within ophthalmology along with a lack of systematic review usage to inform trial design in other areas of medicine. Given these concerns, the aim of this study is to evaluate the use of systematic reviews as justification for conducting randomized controlled trials (RCT) in top ophthalmology and optometry journals. METHODS: We searched PubMed on December 5, 2018 for RCTs published in one of the top five Google Scholar h-5 index journals within Ophthalmology and Optometry. We used a pilot-tested Google Form and searched each RCT for systematic reviews. Each systematic review was then given the designation of "verbatim", "inferred", or "not used as justification for conducting the RCT" based on the context the systematic review was used. RESULTS: Our analysis yielded 152 included phase III RCTs. We found 22.4% (34 of 152) of phase III ophthalmology clinical trials cited a systematic review as justification for conducting the trial. A total of 102 systematic reviews were cited in the 152 RCTs. Fifty-seven of the one hundred fifty-two (37.5%) RCTs cited a systematic review somewhere in the manuscript. CONCLUSION: Less than one-quarter of phase III RCTs cited systematic reviews as justification for conducting the RCT. We believe placing a higher priority on justifying RCTs with systematic reviews would go a long way to minimizing research waste within ophthalmology.

Effects of a proposal to alter the statistical significance threshold on previously published orthopaedic trauma randomized controlled trials.

INTRODUCTION: A recent proposal suggests changing the threshold for statistical significance from a P value of .05 to .005 to minimize bias and increase reproducibility of future studies. P values less than .05 but greater than .005 would be reclassified as "suggestive", whereas P values less than .005 would be considered significant. The present study explores how lowering the P value threshold would affect the interpretation of previously published orthopaedic trauma randomized controlled trials (RCTs) and whether outcomes from these trials would maintain statistical significance under the proposed P value threshold. METHODS: All RCTs published between January 01, 2016 and January 31, 2018 in the Journal of Orthopaedic Trauma, Injury, and Archives of Orthopaedic and Trauma Surgery were screened by at least 2 authors. Data from included trials were extracted in blinded and duplicate fashion. All P values for primary endpoints were included from each study. RESULTS: We identified 124 primary endpoints from 48 trials: 39.5% (49/124) of endpoints had a P value less than .05 and 60.5% (75/124) had a P value greater than .05. Overall, 51.0% (25/49) of statistically significant primary endpoints were less than .005, while 49.0% (24/49) would be reclassified as suggestive. CONCLUSION: Based on our results, adopting a lower threshold of significance would heavily alter the significance of orthopaedic trauma RCTs and should be further evaluated and cautiously considered when viewing the effect such a proposal on orthopaedic practice.