Are Clinical Practice Guidelines Representative of Patients With Distal Radius Fractures? A Review of Patient Demographics and Patient-Reported Outcome Measures Used to Inform Guidelines.

PURPOSE: Clinical practice guidelines (CPGs) are recommendations developed for broad application to optimize high-quality care and decision-making. The composition of patients and outcome measures used in studies informing CPGs; however, has not been rigorously evaluated. With growing evidence that outcomes in musculoskeletal surgery vary by sociocultural factors, we aimed to: (1) review the linguistic, racial, and ethnic representation of the patients in the studies informing CPGs for distal radius fractures and (2) assess their use of linguistically and culturally adapted patient-reported outcome measures (PROMs). METHODS: The American Academy of Orthopaedic Surgeons website was used to identify relevant studies. Key variables were extracted, including inclusion and exclusion criteria, language of study, patient language and proficiency, patient race and ethnicity, and use of translated or culturally adapted PROMs. If provided, the clinical trial registration page for the study was evaluated. Descriptive statistics were used to describe the frequency of each variable. RESULTS: Fifty-four published texts were evaluated. Participant language was reported in four (7%) of the published texts and six (11%) when including the clinical trial registration information. Of the published texts, one (2%) reported ethnic group/race data and 40 (74%) used PROMs. Of those using PROMs, eight (20%) of 40 reported the use of translated PROMs, and three (8%) of 40 reported the use of culturally adapted PROMs. CONCLUSIONS: There is a lack of reporting of linguistic, racial, and ethnic data and inconsistent use of PROMs, particularly those that are translated and culturally adapted, in studies included in the American Academy of Orthopaedic Surgeons CPG for distal radius fractures. As sociocultural characteristics and PROMs are associated with outcomes, ensuring they are broadly represented in studies, may improve equity and shared decision-making. CLINICAL RELEVANCE: Greater inclusion and reporting of demographic data and PROMs are required in musculoskeletal studies to ensure broad applicability and advance health equity.

Are Orthopaedic Clinical Trials Linguistically and Culturally Diverse? A Systematic Review.

Purpose: Underrepresentation and misrepresentation of historically underrepresented populations in randomized controlled trials (RCTs) may have implications for the validity of research results and their application for diverse populations. To evaluate the representation of historically linguistically, racially, and ethnically underrepresented participants in orthopaedic randomized controlled trials (RCTs) and to assess the use of translated and culturally adapted patient reported outcome measures (PROMs). Methods: Separate and comprehensive literature searches of PubMed, Web of Science, and Embase databases were performed to identify RCTs utilizing PROMs between the years 2012 - 2022 among the top five highest 5-year impact factor orthopaedic journals according to the 2021 Journal Citation Reports database. The primary outcomes of interest included reporting of linguistic, racial and ethnic demographic characteristics of trial participants and the utilization of translated PROMs. The methodological quality of each clinical trial was assessed using the Jadad Criteria. Results: 230 RCTs met inclusion criteria. The language of participants was reported in 14% of trials and in 17% of trials when searching both the published text and clinical trial registration information. In addition, race and/or ethnicity was reported in 11% of trials, and the use of translated PROMs was reported in 7% of trials. Among the six multinational studies, none reported the language of the study population nor the use of translated PROMs. Notably, four studies (2%) reported utilizing culturally adapted PROMs. The average Jadad score was 3.07. Conclusion: Participant language, race, and ethnicity are infrequently reported in orthopaedic clinical trials, potentially limiting the application and interpretation of study results. Similarly, the linguistic and cultural adaptation of PROMs utilized are often not reported, which also limits interpretations of the validity and generalizability of orthopedic study results. Researchers and journals should promote standard reporting of demographic data and methods of PROM adaptation to ensure results are generalizable to diverse patient populations. Level of Evidence: III.

A scoping review of Ayurvedic rasayana adaptogens in oncology.

INTRODUCTION: Rasayanas are Ayurvedic natural products that have adaptogenic effects. The extensive research on rasayanas in oncology is not currently well summarized. The aim of this review is to investigate the range and nature of the current body of research, identify gaps in knowledge, and to summarize the existing literature as it relates to Ayurvedic rasayanas and oncology. MATERIALS AND METHODS: A comprehensive literature search of fifteen Ayurvedic adaptogen rasayanas was conducted using three main concepts: Ayurvedic herbal terms, neoplasm terms, and oncological pathways. After screening was performed, key variables were extracted (tagged) including type of adaptogen, cancer type, type of study design, constituent type, and mechanisms of action (MOA). The results were synthesized and summarized using descriptive statistics and narrative summaries. RESULTS: Five hundred and eighty-four articles were reviewed and tagged. The two most tagged adaptogens were Glycyrrhiza glabra (Yashthimadhu/licorice) (n = 166 (28.4 %)) and Withania somnifera (Ashwagandha) (n = 151 (25.9 %)). The most frequently tagged cancer diagnostic categories were gastrointestinal (n = 175 (30 %)), and breast (n = 126 (21 %)). Most of the articles focused on in vitro studies (n = 470 (80.3 %)). Of the 12 MOA tags, the most frequently tagged was apoptosis (n = 298 (29.2 %)). CONCLUSION: A large body of pre-clinical literature exists on adaptogen rasayanas in oncology, indicating this field of research is still in its early phase. Comparatively few studies focused on the effects on the immune system. Given the growing interest in immuno-oncology therapeutics and the potential impact of adaptogen rasayanas on the immune system, future research may focus more in this area, along with work that is more directly linked to future clinical studies.