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

PURPOSE: This 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. METHODS: A 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. RESULTS: Of 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. CONCLUSIONS: The 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.

The Variability of MCID, SCB, PASS, and MOI Thresholds for PROMs in the Reverse Total Shoulder Arthroplasty Literature: A Systematic Review.

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) is a common procedure utilized to address degenerative pathologies of the glenohumeral joint and rotator cuff. Increased reliance on patient-reported outcome measures (PROMs) has placed emphasis on the utilization of the minimum clinically important difference (MCID), substantial clinical benefit (SCB), patient acceptable symptom state (PASS), and maximal outcome improvement (MOI) thresholds to assess the clinical efficacy of RTSA. In this study, we systematically reviewed the MCID, SCB, PASS, and MOI thresholds reported for PROMs following RTSA. METHODS: PubMed, Embase, MEDLINE, Cochrane Library, and Google Scholar were queried for articles from Jan. 1, 2000-Aug. 31, 2023 reporting MCID, SCB, PASS, or MOI values for PROMs following RTSA. Patient demographic data, study characteristics, MCID/SCB/PASS/MOI thresholds, and threshold calculation methods were extracted. RESULTS: 141 articles were screened with 39 ultimately included, comprising 11,984 total patients that underwent RTSA. 34 (87%) studies reported MCID thresholds, 20 (51%) reported SCB, 5 (13%) reported PASS, and 2 (5%) reported MOI. 25/39 (64%) studies referenced a previous study when reporting MCID, SCB, PASS, or MOI values, 11 (28%) used an anchor-based method to calculate threshold values, 1 (3%) used a distribution-based method, and 2 (5%) used both anchor and distribution methods. There were 19 newly calculated MCID (11), SCB (5), PASS (1), and MOI (2) thresholds. For five of the six most utilized PROMs (ASES, SST, Constant, UCLA, SPADI), the range of reported MCID values exceeded 50% of the most common threshold. For three of the six, the range of SCB values exceeded 25% of the most common threshold. CONCLUSION: There is substantial variability in the MCID and SCB threshold values reported in the RTSA literature. Standardizing the methodologic calculation and utilization of MCID, SCB, PASS, and MOI thresholds for RTSA may allow for improved assessment of PROMs.

Where are the Black men in osteopathic medical schools?

Over the past decade, the American Association of Colleges of Osteopathic Medicine (AACOM) and the Association of American Medical Colleges (AAMC) have emphasized the need to enhance diversity within medical education. Despite concerted efforts, the representation of underrepresented populations in medicine (URiM), particularly Black men, remains alarmingly low. This commentary delves into the persisting challenges and potential solutions surrounding the lack of diversity of Black men in osteopathic schools. Black men, in particular, continue to be significantly underrepresented in osteopathic medical schools across the United States. Factors contributing to this disparity include limited access to resources, pervasive negative stereotypes, and biases within the medical community. Addressing these challenges necessitates multifaceted interventions such as mentorship programs, pipeline initiatives, and implicit bias training to enhance the recruitment and support for URiM applicants, particularly Black men. Institutions like Touro College of Osteopathic Medicine and A.T. Still University have underscored the importance of tailoring programs in fostering a sense of belonging and academic success among Black men aspiring to be osteopathic physicians. The creation of a supportive environment for Black men in osteopathic medical schools is not only crucial for promoting diversity but also crucial for improving patient health outcomes, because research consistently depicts enhanced patient outcomes and experiences with diverse healthcare teams. However, despite progress in some areas, Black men continue to face systemic barriers and biases that hinder the pursuit of a career in osteopathic medicine. Thus, increasing the representation of Black men in osteopathic medical schools requires a concerted effort from all stakeholders, including medical institutions, policymakers, and the broader medical community. By implementing targeted interventions, fostering a sense of belonging, and addressing systemic barriers, the medical community can work toward a more equitable and inclusive future in healthcare. Ultimately, promoting diversity is not only a matter of fairness but also essential for ensuring the delivery of high-quality, culturally competent care to all patients.

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

OBJECTIVES: 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. DESIGN: PubMed, Embase, and MEDLINE were queried for RCTs (January 1, 2010 to February 28, 2023). SETTING: RCTs that evaluated surgical management or treatment of femoral neck fractures were included. STUDY SELECTION CRITERIA: 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. OUTCOME MEASURES AND COMPARISONS: 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. RESULTS: 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). CONCLUSIONS: 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. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The fragility of statistical findings in the reverse total shoulder arthroplasty literature: a systematic review of randomized controlled trials.

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) has seen increasing utilization as an effective intervention for a wide variety of shoulder pathologies. The scope and indications for growth are often driven by findings from randomized controlled trials (RCTs) guiding surgical decision-making for RTSA. In this study, we utilized the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the robustness of outcomes reported in RCTs in the RTSA literature. METHODS: PubMed, Embase, and MEDLINE were queried for RCTs (Jan. 1, 2010-Mar. 31, 2023) in the RTSA literature reporting dichotomous outcomes. The FI and rFI were defined as the number of outcome reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI by the sample size of each study. Subgroup analysis was performed based on outcome category. RESULTS: One hundred seventy-six RCTs were screened with 18 studies included. The median FI across 59 total outcomes was 4 (interquartile range [IQR]: 3-5) with an associated FQ of 0.051 (IQR: 0.029-0.065). Thirteen outcomes were statistically significant with a median FI of 3 (IQR: 1-4) and FQ of 0.033 (IQR: 0.012-0.066). Forty-six outcomes were nonsignificant with a median rFI of 4 (IQR: 3-5) and FQ of 0.055 (IQR: 0.032-0.065). The most fragile outcome category was revision/reoperations with a median FI of 2.50 (IQR: 1.00-3.25), followed by clinical score/outcome (median FI: 3.00), complications (median FI: 4.00), "other" (median FI: 4.00), and radiographic findings (median FI: 5.00). Notably, the number of patients lost to follow-up was greater than or equal to the FI for 59% of outcomes. CONCLUSION: The statistical findings in RTSA RCTs are fragile and should be interpreted with caution. Reversal of only a few outcomes, or maintaining postoperative follow-up, may be sufficient to alter significance of study findings. We recommend standardized reporting of P values with FI and FQ metrics to allow clinicians to effectively assess the robustness of study findings.

Fragile Statistical Findings in Randomized Controlled Trials Evaluating Autograft Versus Allograft Use in Anterior Cruciate Ligament Reconstruction: A Systematic Review.

PURPOSE: To analyze the statistical stability of randomized controlled trials (RCTs) evaluating the surgical management of autografts versus allografts in the anterior cruciate ligament reconstruction (ACLR) literature and calculate the fragility index (FI) and fragility quotient and explore a subgroup analysis by calculating the proportion of outcome events where the FI was less than the number of patients lost to follow-up. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a systematic search in the PubMed and Cochrane databases to identify RCTs published between 2000 and 2022 that investigated the use of autografts versus allografts in ACLR literature and reported dichotomous data. The fragility index of each dichotomous variable was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient was calculated by dividing each fragility index by the study sample size. The interquartile range also was calculated. RESULTS: Of the 4407 articles screened, 23 met the search criteria, with 11 RCTs evaluating ALCR using autografts and allografts included for analysis. Two hundred and 18 outcome events with 32 significant (P < .05) outcomes and 186 nonsignificant (P ≥ .05) outcomes were identified. The overall fragility index and fragility quotient for all 218 outcomes were 6 subjects (interquartile range 5-8) and 0.058 (interquartile range 0.039-0.077). Fragility analysis of statistically significant outcomes and nonsignificant outcomes had a fragility index of 3.5 (interquartile range 1-5.5) and 6 (interquartile range 5-8), respectively. All of the studies reported a loss to follow-up where 45.5% (5) reported a loss to follow-up greater or equal to 6. CONCLUSIONS: The RCTs in the ACLR peer-reviewed literature evaluating autograft versus allograft use are vulnerable to a small number of outcome event reversals and exemplify significant statistical fragility in statistically significant findings. LEVEL OF EVIDENCE: Level I, systematic review of Level I studies.

The statistical fragility of outcomes in calcaneus fractures: A systematic review of randomized controlled trials.

INTRODUCTION: The purpose of this study was to utilize the fragility index to assess the robustness of randomized controlled trials (RCTs) evaluating the management of calcaneus fractures. We hypothesize that the dichotomous outcomes in calcaneus fracture literature will be statistically fragile and comparable to other orthopedic specialties. METHODS: We performed a PubMed search for calcaneus fracture RCTs from 2000 to 2022 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The fragility index (FI) of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient (FQ) was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 3003 studies screened, 97 met the search criteria, with 19 RCTs evaluating calcaneus fractures included in the analysis. Seventy-nine dichotomous outcomes with 30 significant (P < 0.05) outcomes and 49 with nonsignificant (P> 0.05) outcomes were identified. The overall FI and FQ of all outcomes were 6 (IQR 3-8) and 0.067 (IQR 0.032-0.100), respectively. CONCLUSIONS: The literature surrounding calcaneus fractures may not be as statistically stable as previously thought. The sole reliance on the P value may depict misleading results. We, therefore, recommend reporting the P value in conjunction with the FI and FQ to give a robust contextualization of clinical findings in the calcaneus fracture literature.

The fragility of statistical findings in distal biceps tendon repairs: a systematic review of randomized controlled trials.

BACKGROUND: The purpose of this present study was to perform a fragility analysis to assess the robustness of randomized controlled trials (RCTs) evaluating the distal biceps tendon repairs. We hypothesize that the dichotomous outcomes will be statistically fragile, and higher fragility will exist among statistically significant outcomes comparable to other orthopedic specialties. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), randomized controlled trials from 4 orthopedic journals indexed on PubMed from 2000 to 2022 reporting dichotomous measures relating to distal biceps tendon repairs were included. The fragility index (FI) of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient (FQ) was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 1038 articles screened, 7 RCTs containing 24 dichotomous outcomes were included for analysis. The fragility index and fragility quotient of all outcomes was 6.5 (IQR 4-9) and 0.077 (IQR 0.031-0.123), respectively. However, statistically significant outcomes had a fragility index and fragility quotient of 2 (IQR 2-7) and 0.036 (IQR 0.025-0.091), respectively. The average number of patients lost to follow-up was 2.7 patients, with 28.6% of the included studies reporting loss to follow-up (LTF) greater than or equal to 6.5. CONCLUSIONS: The literature surrounding distal biceps tendon repair may not be as stable as previously thought and presents a similar fragility index to other orthopedic subspecialties. We therefore recommend triple reporting the P value, fragility index, and fragility quotient to aid in the interpretation of clinical findings reported in biceps tendon repair literature.

The Statistical Fragility of Orbital Fractures: A Systematic Review of Randomized Controlled Trials.

BACKGROUND: The P value has often been used as a tool to determine the statistical significance and evaluate the statistical robustness of study findings in orthopedic literature. The purpose of this study is to apply both the fragility index (FI) and the fragility quotient (FQ) to evaluate the degree of statistical fragility in orbital fracture literature. We hypothesized that the dichotomous outcomes within the orbital fracture literature will be vulnerable to a small number of outcome event reversals and will be statistically fragile. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), the authors identified all dichotomous data for randomized controlled trials (RCTs) in orbital fracture literature and performed a PubMed search from 2000 to 2022. 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 FI by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 3,329 studies screened, 28 met the criteria with 10 RCTs evaluating orbital fractures included for analysis. A total of 58 outcome events with 22 significant (P < .05) outcomes and 36 nonsignificant (P ≥ .05) outcomes were identified. The overall FI and FQ for all 58 outcomes was 5 (IQR: 4 to 5) and 0.140 (IQR: 0.075 to 0.250), respectively. Fragility analysis of statistical significant outcomes and nonsignificant outcomes had an FI of 3.5 with no IQR and 5 (IQR 4-5), respectively. All of the studies reported a loss to follow-up data, where 20% (2) was greater than the overall FI of 5. CONCLUSION: The orbital fracture literature provides treatment guidance by relying on statistical significant results from RCTs. However, the RCTs in the orbital fracture peer-reviewed literature may not be statistically stable as previously thought. The sole reliance of the P value may depict misleading results. Thus, we recommend standardizing the reporting of the P value, FI, and FQ in the orbital fracture literature to aid readers in reliably drawing conclusions based on fragility outcome measures impacting clinical decision-making.

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

BACKGROUND: The 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. METHODS: We 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. RESULTS: Of 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. CONCLUSIONS: The 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.

The fragility of statistical significance in distal femur fractures: systematic review of randomized controlled trials.

PURPOSE: The 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 femur fracture (DFF) literature. We hypothesized that the dichotomous outcomes within the DFF literature are statistically fragile. METHODS: Using preferred reporting items for systematic reviews and meta-analyses, we performed a PubMed search for distal femur 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. RESULTS: Of the 4258 articles screened, 92 met the search criteria, with eleven RCTs included for analysis. Ninety eight outcome events with 25 significant (P < 0.05) outcomes and 73 nonsignificant (P > 0.05) outcomes were identified. The overall FI and FQ for all 98 outcomes were 5 (IQR 4-6) and 0.130 (IQR 0.087-0.174), respectively. Three studies (33.3%) reported loss to follow (LTF) greater than 5. CONCLUSIONS: The randomized controlled trials in the peer-reviewed distal femur 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.

Fracture healing research: Recent insights.

Bone has the rare capability of scarless regeneration that enables the complete restoration of the injured bone area. In recent decades, promising new technologies have emerged from basic, translational and clinical research for fracture treatment; however, 5-10 % of all bone fractures still fail to heal successfully or heal in a delayed manner. Several comorbidities and risk factors have been identified which impair bone healing and might lead to delayed bone union or non-union. Therefore, a considerable amount of research has been conducted to elucidate molecular mechanisms of successful and delayed fracture healing to gain further insights into this complex process. One focus of recent research is to investigate the complex interactions of different cell types and the action of progenitor cells during the healing process. Of particular interest is also the identification of patient-specific comorbidities and how these affect fracture healing. In this review, we discuss the recent knowledge about progenitor cells for long bone repair and the influence of comorbidities such as diabetes, postmenopausal osteoporosis, and chronic stress on the healing process. The topic selection for this review was made based on the presented studies at the 2022 annual meeting of the European Calcified Tissue Society (ECTS) in Helsinki.

The Fragility of Statistical Findings in Distal Radius Fractures: A Systematic Review of Randomized Controlled Trials.

PURPOSE: Probability analysis with reporting of P values is often used to determine the statistical significance of study findings in the orthopedic literature. The fragility index (FI) has been used to evaluate the robustness of a significant result. The purpose of this study was to determine the utility of applying a fragility analysis to randomized controlled trials (RCTs) evaluating distal radius fractures (DRFs). METHODS: We identified all dichotomous outcome data for randomized controlled trials of distal radius fractures (DRFs) published in 13 orthopedic journals from 2000 to 2020. The fragility index (FI) was determined by the number of event reversals required to change a P value from less than 0.05 to greater than 0.05, or vice-versa. The associated fragility quotient (FQ) was determined by dividing the FI by the sample size. The interquartile ranges (IQR) for the FI and FQ were calculated as the difference between the 25th and 75th percentiles for the overall study. RESULTS: Of the 7352 studies screened, 221 met the search criteria, with 34 randomized controlled trials evaluating distal radius fractures and 151 total outcome events included for analysis. The overall FI was 9 (IQR 6.5-11) with an associated fragility quotient of 0.097 (IQR 0.060-0.140). However, a majority of outcomes (78.8%) were not significant. Fragility analysis of statistically significant outcomes had an FI of 4 (IQR 1-10). All of the studies reported lost to follow-up (LTF) data where 20.6% reported lost to follow-up of greater or equal to 9. CONCLUSION: The RCTs in distal radius fracture outcomes have comparable statistical robustness to literature in other orthopedic surgical specialties, are not as statistically stable as previously thought and should be interpreted with caution. We recommend that orthopedic literature report the FI and FQ along with the P values to help the reader draw reliable conclusions based on the fragility of outcome measures. LEVEL OF EVIDENCE: Level I.