Who are we missing? Language exclusivity of patient-reported outcomes in atrial fibrillation clinical trials.

INTRODUCTION: Patient-reported outcomes (PROs) are increasingly used to evaluate quality of life (QoL) in Atrial Fibrillation (AF) patients, providing crucial insights in clinical trials. This study examines the frequency of PRO use in AF trials and the linguistic accessibility of AF-specific PROs. BACKGROUND: As the United States becomes more multilingual, ensuring PROs are available in various languages is vital. The number of people speaking a language other than English at home has tripled from 23.1 million in 1980 to 67.8 million in 2019. This diversity necessitates the availability of PROs in multiple languages for inclusive clinical assessments. METHODS: We queried ClinicalTrials.gov for all US interventional AF trials up to November 28, 2023, reviewing each for PRO usage as primary or secondary outcomes. We identified the five most common AF-specific and generic PROs, extracting their available translations and original languages from published sources. RESULTS: Of 233 identified trials, 191 had associated publications, with 180 (94.2%) conducted solely in English. Only one trial (0.4%) used an AF-specific PRO as a primary outcome, compared to four (1.7%) with a generic PRO. Ten trials (4.3%) used AF-specific PROs as secondary endpoints, versus 22 (9.4%) using generic PROs. AF-specific PROs had significantly fewer translations than generic PROs (11.2 vs. 148.8; p < .001). The AF Effect on Quality-of-Life (AFEQT) was available in 24 languages, with limited translations in commonly spoken US languages like Arabic and Asian languages. CONCLUSION: The limited availability of AF-specific PRO translations highlights a barrier to inclusive AF clinical trials. Expanding translations for AF-specific PROs is crucial for equitable QoL assessments.

Outcome measures in total hip arthroplasty: have our metrics changed over 15 years?

INTRODUCTION: Consensus has not been reached regarding ideal outcome measures for total hip arthroplasty (THA) clinical evaluation and research. The goal of this review was to analyze the trends in outcome metrics within the THA literature and to discuss the potential impact of instrument heterogeneity on clinical practice. MATERIALS AND METHODS: A PubMed search of all manuscripts related to THA from January 2005 to December 2019 was performed. Statistical and linear regression analyses were performed for individual outcome metrics as a proportion of total THA publications over time. RESULTS: There was a statistically significant increase in studies utilizing outcomes metrics between 2005 and 2019 (15.1-29.5%; P < 0.001; R2 = 98.1%). Within the joint-specific subcategory, use of the Harris Hip Score (HHS) significantly decreased from 2005 to 2019 (82.8-57.3%; P < 0.001), use of the Hip Disability and Osteoarthritis Outcome Score (HOOS) significantly increased (0-6.7%; P < 0.001), and the modified HHS significantly increased (0-10.5%; P < 0.001). In the quality of life subcategory, EQ-5D demonstrated a significant increase in usage (0-34.8%; P < 0.001), while Short Form-36 significantly decreased (100% vs. 27.3%; P = 0.008). CONCLUSIONS: The utilization of outcome-reporting metrics in THA has continued to increase, resulting in added complexity within the literature. The utilization rates of individual instruments have shifted over the past 15 years. Additional study is required to determine which specific instruments are recommended.

Evolving Outcome Measures in Total Knee Arthroplasty: Trends and Utilization Rates Over the Past 15 Years.

BACKGROUND: Patient-reported outcome metrics and reporting are important for demonstrating value associated with total knee arthroplasty (TKA). This review studied the patient-reported outcome utilization trends as reported within the TKA literature over a 15-year period. METHODS: A PubMed search of all manuscripts related to TKA from January 2005 to December 2019 was performed. Descriptive statistics were used for individual outcome metrics as proportions of total article publications focusing on TKA outcomes. Linear regressions analysis was performed to demonstrate significant changes in utilization rates over time. RESULTS: There was a significant overall increase in studies utilizing outcome metrics between 2005 and 2019 (16.1%-45.0%; P < .001; R2 = 98.7%). Within joint-specific metrics (2005-2019), use of Knee Disability and Osteoarthritis Outcome score increased (0%-14.8%; P < .001); while use of Knee Society Knee Scoring System decreased (55.2%-35.4%; P = .007). Of the studies reporting general health, use of the Forgotten Joint Score-12 decreased (100%-66.7% from 2014 to 2019; P = .006), and Patient-Reported Outcome Measurement Information System Global-10 increased (0%-21.4% from 2005 to 2019; P < .001). In the quality of life subcategory (2005-2019), EuroQol 5-Dimension Health Outcome Survey increased in usage (14.3%-28.0%; P < .001), while Short Form-36 use decreased (85.7%-36.6%; P < .001). CONCLUSION: Although utilization of outcome metrics has significantly increased over the last 15 years in the TKA literature, there still exists considerable heterogeneity of outcome metrics. This lack of consensus may impede comparisons of studies for clinical and research purposes, as well as hinder cross-walk of outcome tools over time. Further study is needed to identify ideal global and joint-specific tools, while balancing issues like ease of use and utility in specific populations such as the young and highly active.

How Are We Measuring Cost-Effectiveness in Total Joint Arthroplasty Studies? Systematic Review of the Literature.

BACKGROUND: As volumes of total hip arthroplasty (THA) and total knee arthroplasty (TKA) continue to rise, it is important to understand their economic impact. No systematic review on cost-effectiveness of THA/TKA has been performed since 2016 despite recent changes in the healthcare environment. The purpose of the study is to provide a contemporary analysis of the cost-effectiveness of total joint arthroplasty and the use of quality-adjusted life years (QALYs). METHODS: A systematic review was performed from 2005 to 2020. Online databases (OVID Medline, PubMed, Cost-Effectiveness Analysis Registry, Google Scholar, Elton B. Stephens Co) were queried to identify economic analyses that evaluated the cost-effectiveness of THA/TKA. RESULTS: In total, 38 studies met the screening criteria. Study designs were primarily Markov models (68%), cohort studies (16%), and randomized trials (8%). Most studies adopted either a societal perspective (45%) or a health system perspective (39%). Analysis revealed that THA/TKA was strongly cost-effective compared to nonsurgical treatment. THA/TKA procedures that were not delayed were more cost-effective than delayed intervention. The majority of studies used QALYs as the primary quality metric (82%); in all these studies there was a significant improvement in QALYs gained. CONCLUSION: Given the high economic impact of arthroplasty, ongoing assessment of cost-effectiveness is needed. Twenty-four percent of studies included in this systematic review were published in the last 4 years of this 15-year study period, highlighting the need for continuous assessment of aggregate data. Future studies should incorporate the cost-effectiveness of THA and TKA with respect to the work-value provided by surgeon providers to support health policy and reimbursement.

American Association of Hip and Knee Surgeons-Endorsed Comorbidity Coding for Total Joint Arthroplasty: How Often Did We Hit the Mark With International Classification of Diseases, Ninth Revision?

BACKGROUND: Initiatives led by the American Academy of Orthopaedic Surgeons and the American Association of Hip and Knee Surgeons (AAHKS) have indicated a number of clinical risk factors associated with total joint arthroplasty that might reflect the complexity of contemporary hip and knee care. This study sought to examine the prevalence of specific International Classification of Diseases, Ninth Revision (ICD-9), coding with respect to an AAHKS-endorsed list of comorbidity codes. METHODS: An administrative data set from an academic arthroplasty referral center was analyzed in an attempt to measure the prevalence of clinical risk factors (ICD-9) endorsed by AAHKS. Total, partial, and revision joint arthroplasty procedures from January 1, 2012, to April 27, 2015, were included. Demographic data, along with diagnosis and procedural coding data, were collected and analyzed. RESULTS: Results analysis found a number of poorly coded variables. The following variables were omitted in the data: narcotic use, worker's compensation status, previous intra-articular infection, previous open reduction and internal fixation knee, and depression/psychiatric disease. Likewise, there was a discrepancy between the rate of ICD coding for obesity and body mass index measurements and categorization recorded in the clinic. CONCLUSION: From this single-center study, there remain opportunities for coding to adequately reflect the comorbidities and complexities of patients undergoing arthroplasty.

Inequities in Atrial Fibrillation Trials: An Analysis of Participant Race, Ethnicity, and Sex Over Time.

BACKGROUND: Despite the importance of racial and ethnic representation in clinical trials, limited data exist regarding the enrollment trends of these groups in atrial fibrillation (AF) trials over time. OBJECTIVES: The purpose of this study is to examine the characteristics of contemporary AF clinical trials and evaluate their association with race and ethnicity over time. METHODS: We performed a systematic search of all completed AF trials registered in ClinicalTrials.gov between conception to December 31, 2023 and manually extracted composition of race/ethnicity. We stratified trials by study characteristics, including impact factor, publication status, funding source, and location. We calculated the participation prevalence ratio (PPR) by dividing the percentage of non-White participants by the percentage of non-White participants among the disease population (PPR 0.8-1.2 suggests proportional representation) over time. RESULTS: We identified 277 completed AF trials encompassing a total of 1,933,441 adults, with a median proportion of non-White at 12% (IQR: 6-27), 121 (43.7%) device-focused, and 184 (66.4%) funded by industry. Only 36.1% of trials reported comprehensive race information. Overall, non-White participants were underrepresented (PPR = 0.511; P < 0.001), including Black (PPR = 0.263) and Hispanic (PPR = 0.337) participants. The proportion of non-White participants did not change significantly between 2000 and 2023 (11% vs 9%; P = 0.343). CONCLUSION: Despite greater awareness, race/ethnicity reporting and representation of non-White groups in AF clinical trials are poor and have not improved significantly over time. These findings demand additional recruitment efforts and novel recruitment policies to ensure adequate representation of these demographic subgroups in future AF clinical trials.

Characteristics of contemporary atrial fibrillation clinical trials and their association with industry sponsorship.

BACKGROUND: Industry sponsorship is an important source of funding for atrial fibrillation (AF) clinical trials, the implications of which have not been analyzed. OBJECTIVE: The purpose of this study was to determine the characteristics of contemporary AF clinical trials and to evaluate their association with funding source. METHODS: We systematically assessed all completed AF trials registered in the ClinicalTrials.gov database between conception to October 31, 2023, and extracted publicly available information including funding source, trial size, demographic distribution, intervention, location, and publication status. Trial characteristics were compared using the Wilcoxon rank-sum test and Fisher exact test for continuous and categorical variables, respectively. RESULTS: Of the 253 clinical trials assessed, 171 (68%) reported industry funding. Industry funding was associated with a greater median number of patients enrolled (172 vs 80; P <.001), publication rate (56.7% vs 42.7%; P = .04), probability of being product-focused (48.0% vs 24.4%; P <.001), and multicontinental recruitment location (25.2% vs 2.4%; P <.001) when compared to nonindustry-funded trials. However, industry funding was not associated with a significant difference in median impact factor (7.7 vs 7.7; P = .723). The overall proportion of industry-funded trials did not change over time (P = 1). CONCLUSION: Industry-funded clinical trials in AF often are larger, more frequently published, multicontinental, and product-focused. Industry funding was found to be associated with significant differences in study enrollment and publication metrics.

Outcomes and care quality metrics for people living with rheumatic heart disease and atrial fibrillation in Uganda.

Background: Atrial fibrillation (AF) is a common complication of rheumatic heart disease (RHD) and is challenging to treat in lower-resourced settings in which RHD remains endemic. Objective: We characterized demographics, treatment outcomes, and factors leading to care retention for participants with RHD and AF in Uganda. Methods: We conducted a retrospective analysis of the Uganda national RHD registry between June 2009 and May 2018. Participants with AF or atrial flutter were included. Demographics, survival, and care metrics were compared with participants without AF. Multivariable logistic regression was used to identify factors associated with retention in care among participants with AF. Results: A total of 1530 participants with RHD were analyzed and 293 (19%) had AF. The median age was 24 (interquartile range 14-38) years. Mortality was similar in both groups (adjusted hazard ratio 1.183, P = .77) over a median follow-up of 203 (interquartile range 98-275) days. A total of 79% of AF participants were prescribed anticoagulation, and 43% were aware of their target international normalized ratio. Retention in care was higher in participants with AF (18% vs 12%, P < .01). Factors associated with decreased retention in care include New York Heart Association functional class III/IV (adjusted odds ratio [OR] 0.48, 95% confidence interval [CI] 0.30-0.76) and distance to nearest health center (adjusted OR 0.94, 95% CI 0.90-0.99). Anticoagulation prescription was associated with enhanced care retention (adjusted OR 1.86, 95% CI 1.24-2.79). Conclusion: Participants with RHD and AF in Uganda do not experience higher mortality than those without AF. Anticoagulation prescription rates are high. Although retention in care is poor among RHD participants, those with concurrent AF are more likely to be retained.

Resident Involvement in Posterior Lumbar Interbody Fusion is Associated With Increased Readmissions and Operative Time, But No Increased Short-term Risks.

STUDY DESIGN: A retrospective cohort study. OBJECTIVE: The aim was to compare rates of adverse events and additional posterior lumbar interbody fusion (PLIF) cases assisted by residents versus cases performed solely by an orthopedic attending. SUMMARY OF BACKGROUND DATA: PLIF is a widely accepted surgical technique for the management of a variety of spinal conditions requiring spinal stabilization and fusion. However, no published studies have assessed the effects of resident involvement on intraoperative and postoperative outcomes in PLIF. METHODS: This retrospective study utilized the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) registry from 2007 to 2012 to identify patients who underwent PLIF procedures. A propensity score matching model was utilized to reduce patient cohort variances. The perioperative data and outcomes in the matched population were analyzed using paired t test and the McNemar test in order to assess, based on resident presence, the rates of postoperative adverse events, readmission, reoperation within 30 days, and operative time. RESULTS: In total, 1633 patients undergoing PLIF were included in the study, with 24.62% involving resident participation. The propensity score matching algorithm yielded 396 well-matched resident and nonresident pairs. Patients undergoing PLIF involving a resident were associated with a higher rate of readmission (1.77% vs. 0.00%; P=0.008), and longer operative time (245.7 vs. 197.7 min; P<0.001). However, these procedures were not associated with any significant difference in minor or severe adverse events. CONCLUSIONS: Resident involvement in PLIF was associated with an increased rate of readmissions, and operative time; however, was not associated with an increase in minor or severe adverse events. Further investigation is needed to characterize the role of resident involvement based on level of training experience, as well as methods to improve the learning curve to independence while reducing postoperative hospital length of stay. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Contemporary Outpatient Arthroplasty Is Safe Compared with Inpatient Surgery: A Propensity Score-Matched Analysis of 574,375 Procedures.

BACKGROUND: Outpatient joint arthroplasty is a potential modality for increased case throughput and is rising in demand. However, we are aware of no study that has compared outcomes between risk-matched outpatient and inpatient procedures within the last 7 years. The aims of this study were to compare matched patient cohorts who underwent outpatient or inpatient joint arthroplasty in terms of 30-day adverse events and readmission rates. METHODS: From the National Surgical Quality Improvement Program database, we identified patients who underwent primary total hip arthroplasty (THA), primary total knee arthroplasty (TKA), and primary unicompartmental knee arthroplasty (UKA) from 2009 to 2018. Using 10 perioperative variables, patients who underwent an outpatient procedure were 1:4 propensity score-matched with patients who underwent an inpatient procedure. The rates of 30-day adverse events and readmission were compared using the McNemar test. The risk factors for adverse events and readmissions were identified using multivariate regression. RESULTS: Of 574,375 patients identified, 21,506 (3.74%) underwent an outpatient procedure. After propensity score matching, an outpatient joint arthroplasty was associated with a lower rate of adverse events (3.18% compared with 7.45%; p < 0.001). When assessed individually, outpatient TKA (3.15% compared with 8.11%; p < 0.001), THA (4.94% compared with 10.05%; p < 0.001), and UKA (1.78% compared with 3.39%; p < 0.001) were all associated with fewer adverse events overall and there was no difference in the rate of 30-day readmission, when compared with inpatient analogs. Outpatient joint arthroplasty was an independent factor for lower adverse events (odds ratio [OR], 0.407 [95% confidence interval (CI), 0.369 to 0.449]; p < 0.001), with no increase in the risk of readmission (OR, 1.004 [95% CI, 0.878 to 1.148]; p = 0.951). CONCLUSIONS: Contemporary outpatient joint arthroplasty demonstrated lower rates of adverse events with no increased rate of 30-day readmission when compared with risk-matched inpatient counterparts. Although multiple factors should guide the decision for the site of care, outpatient arthroplasty may be a safe alternative to inpatient arthroplasty. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Characterization of Clinical Symptoms by Race Among Women With Early-Stage, Hormone Receptor-Positive Breast Cancer Before Starting Chemotherapy.

Importance: Race disparities persist in breast cancer mortality rates. One factor associated with these disparities may be differences in symptom burden, which may reduce chemotherapy tolerance and increase early treatment discontinuation. Objectives: To compare symptom burden by race among women with early-stage breast cancer before starting chemotherapy and quantify symptom differences explained by baseline characteristics. Design, Setting, and Participants: A cross-sectional analysis of symptom burden differences by race among Black and White women with a diagnosis of stage I to III, hormone receptor-positive breast cancer who had a symptom report collected before chemotherapy initiation in a large cancer center in the southern region of the US from January 1, 2007, through December 31, 2015. Analyses were conducted from November 1, 2019, to March 31, 2021. Blinder-Oaxaca decomposition was used, adjusting for baseline sociodemographic and clinical characteristics. Main Outcomes and Measures: Four symptom composite scores with a mean (SD) of 50 (10) were reported before starting chemotherapy (baseline) and were derived from symptom items: general physical symptoms (11 items), treatment adverse effects (8 items), acute distress (4 items), and despair (7 items). Patients rated the severity of each symptom they experienced in the past week on a scale of 0 to 10 (where 0 indicates not a problem and 10 indicates as bad as possible). Results: A total of 1338 women (mean [SD] age, 54.6 [11.6] years; 420 Black women [31.4%] and 918 White women [68.6%]) were included in the study. Before starting chemotherapy, Black women reported a statistically significantly higher (ie, worse) symptom composite score than White women for adverse effects (44.5 vs 43.8) but a lower acute distress score (48.5 vs 51.0). Decomposition analyses showed that Black patients' characteristics were associated with higher symptom burden across all 4 scores. However, these differences were offset by relatively greater, statistically significant, unexplained physical, distress, and despair symptom reporting by White patients. Conclusions and Relevance: In this study, before starting chemotherapy, Black patients with early-stage breast cancer reported significantly higher burden for symptoms that may be exacerbated with chemotherapy and lower distress symptoms compared with White patients. Future studies should explore how symptoms change before and after treatment and differ by racial/ethnic groups and how they are associated with treatment adherence and mortality disparities.

Post-acute care disparities in total joint arthroplasty.

BACKGROUND: Understanding the socioeconomic factors that influence hospitalization and post-discharge metrics after joint replacement is important for identifying key areas of improvement in the delivery of orthopaedic care. METHODS: An institutional administrative data set of 2869 patients from an academic arthroplasty referral center was analyzed to quantify the relationship between socioeconomic factors and post-acute rehabilitation care received, length of stay, and cost of care. The study used International Classification of Disease, ninth edition coding in order to identify cohorts of patients who received joint arthroplasty of the knee and hip between January 2007 and May 2015. RESULTS: The study found that females (odds ratio [OR], 2.07; 95% confidence interval [CI], 1.74-2.46), minorities (OR, 2.11; 95% CI, 1.78-2.51), and non-private insurance holders (OR, 1.56; 95% CI, 1.26-1.94) were more likely to be assigned to institutional care after discharge. The study also found that minorities (OR, 1.45; 95% CI, 1.24-1.70) and non-private insurance holders (OR, 1.43; 95% CI, 1.16-1.77) are more likely to exhibit longer length of stay. Mean charges were higher for males when compared to females ($80,010 vs $74,855; P < .001), as well as total costs ($19,910 vs $18,613; P = .001). CONCLUSIONS: Socioeconomic factors such as gender, race, and insurance status should be further explored with respect to healthcare policies seeking to influence quality of care and health outcomes.

Does the Timing of Pre-Operative Medical Evaluation Influence Perioperative Total Hip Arthroplasty Outcomes?

BACKGROUND: Medical evaluation pre-operatively is an important component of risk stratification and potential risk optimization. However, the effect of timing prior to surgical intervention is not well-understood. We hypothesized that total hip arthroplasty (THA) patients seen in pre-operative evaluation closer to the date of surgery would experience better perioperative outcomes. METHODS: We retrospectively reviewed 167 elective THA patients to study the relationship between the number of days between pre-operative evaluation (range, 0-80 days) and surgical intervention. Patients' demographics, length of stay (LOS), ICU admission frequency, and rate of major complications were recorded. RESULTS: When pre-operative evaluation carried out 4 days or less before the procedure date, there was a significant reduction in LOS (3.91 vs. 4.49; p=0.03). When pre-operative evaluation carried out 11 days or less prior to the procedure date, there was a four-fold decrease in rate of intensive care admission (p=0.04). Furthermore, the major complication rate also significantly reduced (p<0.05). However, when pre-operative evaluation took place 30 days or less before the procedure date compared to more than 30 days prior, there were no significant changes in the outcomes. CONCLUSION: From this study, pre-operative medical evaluation closer to the procedure date was correlated with improved selected peri-operative outcomes. However, further study on larger patient groups must be done to confirm this finding. More study is needed to define the effect on rare events like infection, and to analyze the subsets of THA patients with modifiable risk factors that may be time-dependent and need further time to optimization.