Understanding Financial Relationships Between Orthopedic Surgeons and Industry for Research.

OBJECTIVE: This study sought to understand trends in industry payments for research awarded to orthopedic surgeons. MATERIALS AND METHODS: The Centers for Medicare & Medicaid Services Open Payments database was queried for the years 2016 to 2021 for industry payments for research. Financial analyses were performed to understand temporal trends and differences by orthopedic subspecialty and principal investigator characteristics such as sex. The threshold for statistical significance was set at .05. RESULTS: A total of 2014 orthopedic surgeons were identified, among whom 542 adult reconstruction (27%) and 460 sports medicine (23%) surgeons were major beneficiaries. Seventy-one female orthopedic surgeons comprised the minority (4%). Total research payments awarded during the study period aggregated to $266,633,592, with adult reconstruction ($88,819,047; 33%) and sports medicine ($57,949,822; 22%) receiving the highest amounts. Total research payments awarded trended upward yearly except for a decline in 2020 that subsequently rebounded (P<.001). Median annual research payment per orthopedic surgeon was $13,375. Median total industry payments per orthopedic surgeon differed between specialties (P <.001), with the highest amounts for adult reconstruction ($44,063) and sports medicine ($34,567) and the lowest amounts for hand ($12,052) and foot and ankle ($19,233). Median total payments did not differ significantly when stratified by sex (P=.276) and region (P=.906). Specialties in which the respective top three companies offered the majority of the research funding were musculoskeletal oncology (90%), pediatric orthopedics (66%), and shoulder and elbow (64%). CONCLUSION: These results can be used as a primer for orthopedic surgeons seeking to leverage industry relationships to fund translational research. [Orthopedics. 2024;47(3):172-178.].

Cost-Effectiveness of Robot-Assisted Radical Cystectomy vs Open Radical Cystectomy for Patients With Bladder Cancer.

Importance: The value to payers of robot-assisted radical cystectomy with intracorporeal urinary diversion (iRARC) when compared with open radical cystectomy (ORC) for patients with bladder cancer is unclear. Objectives: To compare the cost-effectiveness of iRARC with that of ORC. Design, Setting, and Participants: This economic evaluation used individual patient data from a randomized clinical trial at 9 surgical centers in the United Kingdom. Patients with nonmetastatic bladder cancer were recruited from March 20, 2017, to January 29, 2020. The analysis used a health service perspective and a 90-day time horizon, with supplementary analyses exploring patient benefits up to 1 year. Deterministic and probabilistic sensitivity analyses were undertaken. Data were analyzed from January 13, 2022, to March 10, 2023. Interventions: Patients were randomized to receive either iRARC (n = 169) or ORC (n = 169). Main Outcomes and Measures: Costs of surgery were calculated using surgery timings and equipment costs, with other hospital data based on counts of activity. Quality-adjusted life-years were calculated from European Quality of Life 5-Dimension 5-Level instrument responses. Prespecified subgroup analyses were undertaken based on patient characteristics and type of diversion. Results: A total of 305 patients with available outcome data were included in the analysis, with a mean (SD) age of 68.3 (8.1) years, and of whom 241 (79.0%) were men. Robot-assisted radical cystectomy was associated with statistically significant reductions in admissions to intensive therapy (6.35% [95% CI, 0.42%-12.28%]), and readmissions to hospital (14.56% [95% CI, 5.00%-24.11%]), but increases in theater time (31.35 [95% CI, 13.67-49.02] minutes). The additional cost of iRARC per patient was £1124 (95% CI, -£576 to £2824 [US $1622 (95% CI, -$831 to $4075)]) with an associated gain in quality-adjusted life-years of 0.01124 (95% CI, 0.00391-0.01857). The incremental cost-effectiveness ratio was £100 008 (US $144 312) per quality-adjusted life-year gained. Robot-assisted radical cystectomy had a much higher probability of being cost-effective for subgroups defined by age, tumor stage, and performance status. Conclusions and Relevance: In this economic evaluation of surgery for patients with bladder cancer, iRARC reduced short-term morbidity and some associated costs. While the resulting cost-effectiveness ratio was in excess of thresholds used by many publicly funded health systems, patient subgroups were identified for which iRARC had a high probability of being cost-effective. Trial Registration: ClinicalTrials.gov Identifier: NCT03049410.

Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness.

INTRODUCTION: Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective. METHODS AND ANALYSIS: PHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients' lifetime. ETHICS AND DISSEMINATION: Formal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration number ISRCTN84013636.

An Estimation of the Burden of Sports Injuries among African Adolescents.

The extent to which sports injuries contribute to the burden of injury among adolescents in low- and middle-income countries (LMICs) is unknown. The goal of this study was to estimate the incidence of sports injuries among adolescents in Africa. Data from the World Health Organization Global School-Based Student Health surveys were used to estimate the annual number of African adolescents sustaining sports injuries. Gender-stratified injury rates were calculated and applied to every African country's adolescent population to estimate country-specific and continent-wide injury totals. A total of 21,858 males and 24,691 females from 14 countries were included in the analysis. Country-specific annual sports injury rates ranged from 13.5% to 38.1% in males and 5.2% to 20.2% in females. Weighted average sports injury rates for males and females were 23.7% (95% CI 23.1%-24.2%) and 12.5% (95% CI 12.1%-12.9%), respectively. When these rates were extrapolated to the adolescent populations of the African continent, an estimated 15,477,798 (95% CI 15,085,955-15,804,333) males and 7,943,625 (95% CI 7,689,429-8,197,821) females sustained sports injuries. Our findings suggest that over 23 million African adolescents sustained sports injuries annually. Further work will help to more precisely define the burden of sports injuries in LMICs and the role that surgery can play in mitigating this burden.

PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial.

BACKGROUND: Anaemia is common in patients undergoing major surgery. The current standard of care for patients with low haemoglobin in the peri-operative period is blood transfusion. The presence of preoperative anaemia is associated with an increased likelihood of the patient receiving peri-operative transfusion and worsened outcomes following surgery, more post-operative complications, delayed recovery and greater length of hospital stay. Intravenous iron, if applied in the preoperative setting, may correct anaemia by the time of surgery and reduce the need for blood transfusion and improve outcomes. METHODS/DESIGN: PREVENTT is a phase III double-blind randomised controlled trial that will compare the use of intravenous ferric carboxymaltose (dose 1000 mg) with placebo 10-42 days before major open abdominal surgery in 500 patients with anaemia (haemoglobin < 120 g/L). The primary outcome measure will be the need for blood transfusion and secondary endpoints will include post-operative recovery, length of hospital stay, health care utilisation and cost analysis. TRIAL REGISTRATION: ISRCTN67322816--registered 9 October 2012. ClinicalTrials.gov identifier: NCT01692418.

Validation and reliability testing of the EORTC QLQ-NMIBC24 questionnaire module to assess patient-reported outcomes in non-muscle-invasive bladder cancer.

BACKGROUND: Well-developed and well-tested patient-reported outcome measures for non-muscle-invasive bladder cancer (NMIBC) are required. OBJECTIVE: To test and adapt the scale structure and explore the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire for NMIBC. DESIGN, SETTING, AND PARTICIPANTS: A total of 433 patients in the Bladder COX-2 Inhibition Trial (BOXIT) completed the EORTC QLQ-C30 and NMIBC questionnaires. BOXIT is evaluating the addition of celecoxib to standard treatment in high- and intermediate-risk NMIBC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multitrait scaling investigated and adapted the questionnaire scale structure and evaluated the reliability and validity of the revised scales, as well as responsiveness to change. RESULTS AND LIMITATIONS: A total of 410 patients (94.7%) (79.3% men, 74.6% high risk) returned baseline forms, and the questionnaire response rate was 88.2%. Multitrait scaling confirmed six scales and five single items. Scales and items demonstrated significant differences between patients with good and poor performance status scores (p<0.001). Men reported better sexual function than women (p<0.001). Scale and single-item module scores were not highly correlated with QLQ-C30 scores (evidence of discriminant validity), and the module was responsive to changes in health over time. International and test-retest data are required. CONCLUSIONS: This study demonstrates the evidence-driven adapted scale structure and psychometric data of the EORTC QLQ-NMIBC24 module to use in clinical trials of patients with high- or intermediate-risk bladder cancer.

An electromyographic assessment of the "bear hug": an examination for the evaluation of the subscapularis muscle.

PURPOSE: The lift-off and belly-press tests are common tests for evaluation of the subscapularis. We compared these tests with the recently developed bear-hug test by assessing electromyographic (EMG) activity of the shoulder internal rotators during examination. METHODS: Twenty-one healthy male volunteers (mean age, 22.95 +/- 3.71 years; mean weight, 73.48 +/- 6.93 kg; mean height, 68.76 +/- 2.26 cm) with no previous history of shoulder surgery or injury participated in the study. Fine-wire and surface EMG activity of the glenohumeral joint internal rotators (i.e., upper and lower subscapularis, pectoralis major, and latissimus dorsi) was recorded while 5 subscapularis tests were being performed (bear hug at 0 degrees, 45 degrees, and 90 degrees; lift off; and belly press). Peak EMG values were normalized to the maximum voluntary isometric contraction (MVIC) for each muscle. A 4 (muscle) x 5 (test) analysis of variance with repeated measures on test was used to analyze peak EMG activity (percentage of maximum voluntary isometric contraction). Follow-up univariate analysis of variance and Tukey post hoc analyses were performed for each of the 5 tests. RESULTS: The bear-hug test performed at 45 degrees of shoulder flexion showed significantly greater peak EMG activity in the upper subscapularis (107.64% +/- 63.52%) and lower subscapularis (85.75% +/- 64.69%) compared with the pectoralis major (41.43% +/- 25.42%) and latissimus dorsi (20.32% +/- 15.70%) (P < .05). The bear-hug test performed at 90 degrees of shoulder flexion showed significantly greater peak EMG activity in the lower subscapularis (166.0% +/- 132.71%) compared with the upper subscapularis (97.23% +/- 70.78%), pectoralis major (50.63% +/- 29.60%), and latissimus dorsi (17.56% +/- 13.64%) (P < .05). The belly-press test showed significantly greater peak EMG activity in the upper subscapularis (77.88% +/- 53.23%) and lower subscapularis (71.82% +/- 46.49%) compared with the pectoralis major (18.49% +/- 14.85%) and latissimus dorsi (34.85% +/- 27.73%) (P < .05). CONCLUSIONS: The bear-hug examination performed at 45 degrees of shoulder flexion and the belly-press test may be valuable diagnostic tools in the clinical evaluation of the upper subscapularis muscle. In addition, the bear-hug test at 90 degrees of shoulder flexion may be a valuable diagnostic tool in assessing the clinical function of the lower subscapularis. CLINICAL RELEVANCE: The bear-hug examination performed at specific degrees of shoulder flexion may be a valuable way to assess the function of the subscapularis muscle.