Validation of PROMIS physical function for evaluating outcome after acute Achilles tendon rupture

Background: There is increased demand for valid, reliable, and responsive patient-reported outcome measures (PROMs) to evaluate treatment for Achilles tendon rupture, but not all PROMs currently in use are reliable and responsive for this condition. Purpose: To evaluate the measurement properties of the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) compared with other PROMs used after treatment for acute Achilles tendon rupture. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: A retrospective cohort study with a follow-up questionnaire was performed. All adult patients with an acute Achilles tendon rupture between June 2016 and June 2018 with a minimum 12-month follow-up were eligible for inclusion. Functional outcome was assessed using the PROMIS PF computerized adaptive test (CAT), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL), FAAM-Sports, and Achilles Tendon Total Rupture Score (ATRS). Pearson correlation (r) was used to assess the correlations between PROMs. Absolute and relative floor and ceiling effects were calculated. Results: In total, 103 patients were included (mean age, 44.7 years; 74% male); 82 patients (79.6%) underwent operative repair, while 21 patients (20.4%) underwent nonoperative management. The mean time between treatment and collection of PROMs was 25.3 months (range, 15-36 months). The mean scores were 55.4 +/- 9.2 (PROMIS PF), 92.9 +/- 12.2 (FAAM-ADL), 77.7 +/- 22.9 (FAAM-Sports), and 83.0 +/- 19.4 (ATRS). The ATRS was correlated with FAAM-ADL (r = 0.80; 95% CI, 0.72-0.86; P < .001) and FAAM-Sports (r = 0.86; 95% CI, 0.80-0.90; P < .001). The PROMIS PF was correlated with the FAAM-ADL (r = 0.66; 95% CI, 0.53-0.75; P < .001), FAAM-Sports (r = 0.65; 95% CI, 0.53-0.75; P < .001), and ATRS (r = 0.69; 95% CI, 0.58-0.78; P < .001). The PROMIS PF did not show absolute floor or ceiling effects (0%). The FAAM-ADL (35.9%), FAAM-Sports (15.8%), and ATRS (20.4%) had substantial absolute ceiling effects. Conclusion: The PROMIS PF, FAAM-ADL, and FAAM-Sports all showed a moderate to high mutual correlation with the ATRS. Only the PROMIS PF avoided substantial floor and ceiling effects. The results suggest that the PROMIS PF CAT is a valid, reliable, and perhaps the most responsive tool to evaluate patient outcomes after treatment for an Achilles tendon rupture.Clinical epidemiolog

Operative vs nonoperative treatment of distal radius fractures in adults a systematic review and meta-analysis

Importance No consensus has been reached to date regarding the optimal treatment for distal radius fractures. The international rate of operative treatment has been increasing, despite higher costs and limited functional outcome evidence to support this shift. Objectives To compare functional, clinical, and radiologic outcomes after operative vs nonoperative treatment of distal radius fractures in adults. Data Sources The PubMed/MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases were searched from inception to June 15, 2019, for studies comparing operative vs nonoperative treatment of distal radius fractures. Study Selection Randomized clinical trials (RCTs) and observational studies reporting on the following: acute distal radius fracture with operative treatment (internal or external fixation) vs nonoperative treatment (cast immobilization, splinting, or bracing); patients 18 years or older; and functional outcome. Studies in a language other than English or reporting treatment for refracture were excluded. Data Extraction and Synthesis Data extraction was performed independently by 2 reviewers. Effect estimates were pooled using random-effects models and presented as risk ratios (RRs) or mean differences (MDs) with 95% CIs. Data were analyzed in September 2019. Main Outcomes and Measures The primary outcome measures included medium-term functional outcome measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) and the overall complication rate after operative and nonoperative treatment. Results A total of 23 unique studies were included, consisting of 8 RCTs and 15 observational studies, that described 2254 unique patients. Among the studies that presented sex data, 1769 patients were women [80.6%]. Overall weighted mean age was 67 [range, 22-90] years). The RCTs included 656 patients (29.1%); observational studies, 1598 patients (70.9%). The overall pooled effect estimates the showed a significant improvement in medium-term (<= 1 year) DASH score after operative treatment compared with nonoperative treatment (MD, -5.22 [95% CI, -8.87 to -1.57]; P = .005; I-2 = 84%). No difference in complication rate was observed (RR, 1.03 [95% CI, 0.69-1.55]; P = .87; I-2 = 62%). A significant improvement in grip strength was noted after operative treatment, measured in kilograms (MD, 2.73 [95% CI, 0.15-5.32]; P = .04; I-2 = 79%) and as a percentage of the unaffected side (MD, 8.21 [95% CI, 2.26-14.15]; P = .007; I-2 = 76%). No improvement in medium-term DASH score was found in the subgroup of studies that only included patients 60 years or older (MD, -0.98 [95% CI, -3.52 to 1.57]; P = .45; I-2 = 34%]), compared with a larger improvement in medium-term DASH score after operative treatment in the other studies that included patients 18 years or older (MD, -7.50 [95% CI, -12.40 to -2.60]; P = .003; I-2 = 77%); the difference between these subgroups was statically significant (test for subgroup differences, P = .02). Conclusions and Relevance This meta-analysis suggests that operative treatment of distal radius fractures improves the medium-term DASH score and grip strength compared with nonoperative treatment in adults, with no difference in overall complication rate. The findings suggest that operative treatment might be more effective and have a greater effect on the health and well-being of younger, nonelderly patients.This meta-analysis compares functional, clinical, and radiologic outcomes after operative vs nonoperative treatment of distal radial fractures in adults.Question What outcomes are associated with operative vs nonoperative treatment of distal radius fractures in adults? Findings This meta-analysis of 2254 unique participants in 23 unique studies showed that operative treatment of distal radius fractures improved the medium-term Disabilities of the Arm, Shoulder and Hand questionnaire score and grip strength compared with nonoperative treatment in adults, with no difference in overall complication rate. Meaning These findings suggest that operative treatment might be preferred for distal radius fractures.Clinical epidemiolog

Let's agree to disagree on operative versus nonoperative (LADON) treatment for proximal humerus fractures: study protocol for an international multicenter prospective cohort study

BackgroundThe proximal humerus fracture is a common injury, but the optimal management is much debated. The decision for operative or nonoperative treatment is strongly influenced by patient specific factors, regional and cultural differences and the preference of the patient and treating surgeon. The aim of this study is to compare operative and nonoperative treatment of proximal humerus fractures for those patients for whom there is disagreement about optimal management.Methods and analysisThis protocol describes an international multicenter prospective cohort study, in which all patients of 18 years and older presenting within three weeks after injury with a radiographically diagnosed displaced proximal humerus fracture can be included. Based on patient characteristics and radiographic images several clinical experts advise on the preferred treatment option. In case of disagreement among the experts, the patient can be included in the study. The actual treatment that will be delivered is at the discretion of the treating physician. The primary outcome is the QuickDash score at 12 months. Propensity score matching will be used to control for potential confounding of the relation between treatment modality and QuickDash scores.DiscussionThe LADON study is an international multicenter prospective cohort study with a relatively new methodological study design. This study is a "natural experiment" meaning patients receive standard local treatment and surgeons perform standard local procedures, therefore high participation rates of patients and surgeons are expected. Patients are only included after expert panel evaluation, when there is proven disagreement between experts, which makes this a unique study design. Through this inclusion process, we create two comparable groups whom received different treatments and where expert disagree about the already initiated treatment. Since we are zooming in on this particular patient group, confounding will be largely mitigated. Internationally the treatment of proximal humerus fractures are still much debated and differs much per country and hospital. This observational study with a natural experiment design will create insight into which treatment modality is to be preferred for patients in whom there is disagreement about the optimal treatment strategy.Clinical epidemiolog

Performance of Bt maize event MON810 in controlling maize stem borers Chilo partellus and Busseola fusca in Uganda

Stem borers are major insect pests of maize in Uganda. A study was conducted in 2014–2016 to assess the performance of Bt hybrids expressing Cry1Ab (event MON810) against the two major stem borer species in Uganda – the African stem borer (Busseola fusca) and the spotted stem borer (Chilo partellus) – under artificial infestation. The study comprised 14 non-commercialized hybrids, including seven pairs of Bt and non-Bt hybrids (isolines), three non-Bt commercial hybrids and a conventional stem borer resistant check. All stem borer damage parameters (leaf damage, number of internodes tunneled and tunnel length) were generally significantly lower in Bt hybrids than in their isolines, the conventionally resistant hybrid, and local commercial hybrids. Mean yields were significantly higher by 29.4–80.5% in the Bt hybrids than in the other three categories of non-Bt hybrids. This study demonstrated that Bt maize expressing Cry1Ab protects against leaf damage and can limit entry of stem borers into the stems of maize plants, resulting in higher yield than in the non-transgenic hybrids. Thus, Bt maize has potential to contribute to the overall management package of stem borers in Uganda

Challenges and opportunities in trauma research: study designs and patient-reported outcome measures

In the field of orthopedic trauma surgery, great progress has been made over the last decades which has improved patient care and enhanced the likelihood of surviving serious injury. As a result, focus has shifted from patient survival to improving quality of life and reducing the burden of nonfatal injury. However, research-based advances that improve these outcomes for patients with orthopedic injuries have been constrained. The aims of this thesis were to provideinsight into the value of different study designs which evaluate the effects of medical interventions for trauma patients in everyday clinical practice and to assess the use of patient-reported outcome measures (PROMs) as an integrated part of research practice for the assessment of quality of life after nonfatal trauma injury.</table

Original The potential value of observational studies of elective surgical interventions using routinely collected data

Purpose: To assess the apparent validity of observational studies of elective arthroplasty interventions. Methods: Data from the nationwide Dutch Arthroplasty Register were used. The first case study compared surgical approaches for total hip arthroplasty (posterolateral approach vs. straight lateral approach), where allocation of the intervention was assumed to be mostly independent of patient characteristics. The second case study compared fixation methods (cemented vs. uncemented), where choice of fixation method was expected to depend on patient characteristics. The potential for confounding was quantified by differences between intervention groups and the impact of confounding adjustment. Results: The study of posterolateral approach versus straight lateral approach included 73,750 and 16,557 patients, respectively, and showed no meaningful differences in patient characteristics between treatment groups (standardized mean differences 0.1), as well as a relevant impact of confounding adjustment (Z-scores > 2). Conclusions: This study provides insight in the reasoning behind the credibility of observational studies of surgical interventions using routinely collected data and when confounding is expected to have a major impact and thus additional precautions to limit confounding are needed. (c) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/

Original The potential value of observational studies of elective surgical interventions using routinely collected data

Purpose: To assess the apparent validity of observational studies of elective arthroplasty interventions. Methods: Data from the nationwide Dutch Arthroplasty Register were used. The first case study compared surgical approaches for total hip arthroplasty (posterolateral approach vs. straight lateral approach), where allocation of the intervention was assumed to be mostly independent of patient characteristics. The second case study compared fixation methods (cemented vs. uncemented), where choice of fixation method was expected to depend on patient characteristics. The potential for confounding was quantified by differences between intervention groups and the impact of confounding adjustment. Results: The study of posterolateral approach versus straight lateral approach included 73,750 and 16,557 patients, respectively, and showed no meaningful differences in patient characteristics between treatment groups (standardized mean differences 0.1), as well as a relevant impact of confounding adjustment (Z-scores > 2). Conclusions: This study provides insight in the reasoning behind the credibility of observational studies of surgical interventions using routinely collected data and when confounding is expected to have a major impact and thus additional precautions to limit confounding are needed. (c) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ )Orthopaedics, Trauma Surgery and Rehabilitatio