Eric C. Makhni

High variability in outcome reporting patterns in high-impact ACL literature

BACKGROUND ACL (anterior cruciate ligament) reconstruction is one of the most commonly performed and studied procedures in modern sports medicine. A multitude of objective and subjective patient outcome measures exists; however, nonstandardized reporting patterns of these metrics may create challenges in objectively analyzing pooled results from different studies. The goal of this study was to document the variability in outcome reporting patterns in high-impact orthopaedic studies of ACL reconstruction. METHODS All clinical studies pertaining to ACL reconstruction in four high-impact-factor orthopaedic journals over a five-year period were reviewed. Biomechanical, basic science, and imaging studies were excluded, as were studies with fewer than fifty patients, yielding 119 studies for review. Incorporation of various objective and subjective outcomes was noted for each study. RESULTS Substantial variability in reporting of both objective and subjective measures was noted in the study cohort. Although a majority of studies reported instrumented laxity findings, there was substantial variability in the type and method of laxity reporting. Most other objective outcomes, including range of motion, strength, and complications, were reported in <50% of all studies. Return to pre-injury level of activity was infrequently reported (24% of studies), as were patient satisfaction and pain assessment following surgery (8% and 13%, respectively). Of the patient-reported outcomes, the International Knee Documentation Committee (IKDC), Lysholm, and Tegner scores were most often reported (71%, 63%, and 42%, respectively). CONCLUSIONS Substantial variability in outcome reporting patterns exists among high-impact studies of ACL reconstruction. Such variability may create challenges in interpreting results and pooling them across different studies.

Outcomes assessment in rotator cuff pathology: what are we measuring?

BACKGROUND Assessments used to measure outcomes associated with rotator cuff pathology and after repair are varied. This lack of standardization leads to difficulty drawing comparisons across studies. We hypothesize that this variability in patient-reported outcome measures and objective metrics used in rotator cuff studies persists even in high-impact, peer reviewed journals. METHODS All studies assessing rotator cuff tear and repair outcomes in 6 orthopedic journals with a high impact factor from January 2010 to December 2014 were reviewed. Cadaveric and animal studies and those without outcomes were excluded. Outcome measures included range of motion (forward elevation, abduction, external rotation, and internal rotation), strength (in the same 4 planes), tendon integrity imaging, patient satisfaction, and functional assessment scores. RESULTS Of the 156 included studies, 63% documented range of motion measurements, with 18% reporting range of motion in all 4 planes. Only 38% of studies reported quantitative strength measurements. In 65% of studies, tendon integrity was documented with imaging (38% magnetic resonance imaging/magnetic resonance anrhrogram, 31% ultrasound, and 8% computed tomography arthrogram). Finally, functional score reporting varied significantly, with the 5 most frequently reported scores ranging from 16% to 61% in studies, and 15 of the least reported outcomes were each reported in ≤6% of studies. CONCLUSIONS Significant variability exists in outcomes reporting after rotator cuff tear and repair, making comparisons between clinical studies difficult. Creating a uniformly accepted, validated outcomes tool that assesses pain, function, patient satisfaction, and anatomic integrity would enable consistent outcomes assessment after operative and nonoperative management and allow comparisons across the literature.

Revision Arthroscopic Repair Versus Latarjet Procedure in Patients With Recurrent Instability After Initial Repair Attempt: A Cost-Effectiveness Model

PURPOSE To compare the cost-effectiveness of arthroscopic revision instability repair and Latarjet procedure in treating patients with recurrent instability after initial arthroscopic instability repair. METHODS An expected-value decision analysis of revision arthroscopic instability repair compared with Latarjet procedure for recurrent instability followed by failed repair attempt was modeled. Inputs regarding procedure cost, clinical outcomes, and health utilities were derived from the literature. RESULTS Compared with revision arthroscopic repair, Latarjet was less expensive (

Patient Reported Outcomes Measurement Information System (PROMIS) in the upper extremity: the future of outcomes reporting?

13,672 v

Outcomes After Shoulder and Elbow Injury in Baseball Players: Are We Reporting What Matters?:

15,287) with improved clinical outcomes (43.78 v 36.76 quality-adjusted life-years). Both arthroscopic repair and Latarjet were cost-effective compared with nonoperative treatment (incremental cost-effectiveness ratios of 3,082 and 1,141, respectively). Results from sensitivity analyses indicate that under scenarios of high rates of stability postoperatively, along with improved clinical outcome scores, revision arthroscopic repair becomes increasingly cost-effective. CONCLUSIONS Latarjet procedure for failed instability repair is a cost-effective treatment option, with lower costs and improved clinical outcomes compared with revision arthroscopic instability repair. However, surgeons must still incorporate clinical judgment into treatment algorithm formation. LEVEL OF EVIDENCE Level IV, expected value decision analysis.

A Critical Review: Management and Surgical Options for Articular Defects in the Hip

Patient reported outcomes (PROs) serve an integral role in clinical research by helping to determine the impact of clinical care as experienced by the patient. With recent initiatives in health care policy and pay for performance, outcome reporting is now recognized as a policy-driven requirement in addition to a clinical research tool. For outcome measures to satisfy these regulatory requirements and provide value in understanding disease outcomes, they must be responsive and efficient. Recent research has uncovered certain concerns regarding traditional PROs in patients with upper extremity disability and injury. These include lack of consensus regarding selection of PROs for a given diagnoses, inconsistent techniques of administration of the same PROs, and the administrative burden to patients and providers of completing these forms. To address these limitations, emphasis has been placed on streamlining the outcomes reporting process, and, as a result, the National Institutes of Health (NIH) created the Patient Reported Outcomes Measurement Information System (PROMIS). PROMIS forms were created to comprehensively and efficiently measure outcomes across multiple disease states, including orthopedics. These tools exist in computer adaptive testing and short forms with the intention of more efficiently measuring outcomes compared with legacy PROs. The goals of this review are to highlight the main components of PROMIS reporting tools and identify recent use of the scores in the upper extremity literature. The review will also highlight the research and health policy potentials and limitations of implementing PROMIS into everyday orthopedic practice.

Variable reporting of functional outcomes and return to play in superior labrum anterior and posterior tear

Background: Return to play, as well as time to return to play, are the most important metrics considered by athletes when attempting to make treatment decisions after injury. However, the consistency of reporting of these metrics in the scientific literature is unknown. Purpose: To investigate patterns of outcomes reporting in the medical literature of shoulder and elbow injuries in active baseball players. Study Design: Systematic review. Methods: A systematic review of literature published within the past 10 years was performed to identify all recent clinical studies focusing on shoulder and elbow injuries in baseball players across all levels. Review articles, case reports, and laboratory/biomechanical studies were all excluded. Results: A total of 49 studies were included for review. The majority of studies were either level 3 or level 4 evidence (96%). In total, 71% of studies reported on rates of return to preinjury level of play, whereas 31% of studies reported on time to return to preinjury level of play. Only 47% of studies reported on both rate and time of return to preinjury level of play. A minority of studies (8%) reported patient satisfaction rates. Finally, 27 different subjective and patient-reported outcomes were reported, and none of these appeared in more than 14% of all studies. Conclusion: Time to return to preinjury level of play is inadequately reported in studies of shoulder and elbow injury in baseball players. Similarly, satisfaction rates and scores are underreported. Finally, the significant variability of subjective and patient-reported outcomes utilized may undermine the ability of clinicians to accurately compare results from different studies.

High Degree of Variability in Reporting of Clinical and Patient-Reported Outcomes After Hip Arthroscopy

Patients with articular cartilage lesions of the hip may present with pain and symptoms that may be vague in nature and onset. Therefore, a thorough history and physical examination should be performed for every patient presenting with hip pain and/or disability. The management may be operative or nonoperative. Nonoperative management includes a trial of rest and/or activity modification, along with anti-inflammatory medications, physical therapy, and biologic injections. Operative treatment in the form of arthroscopic techniques continues to decrease morbidity and offer innovative solutions and new applications for microfracture, ACT, and AMIC.

How Comprehensive and Efficient Are Patient-Reported Outcomes for Rotator Cuff Tears?

BACKGROUND Outcomes assessments after superior labrum anterior and posterior (SLAP) tear/repair are highly varied, making it difficult to draw comparisons across the literature. This study examined the inconsistency in outcomes reporting in the SLAP tear literature. We hypothesize that there is significant variability in outcomes reporting and that although most studies may report return to play, time to return reporting will be highly variable. METHODS The PubMed, Medline, Scopus, and Embase databases were systematically reviewed for studies from January 2000 to December 2014 reporting outcomes after SLAP tear/repair. Two reviewers assessed each study, and those meeting inclusion criteria were examined for pertinent data. Outcomes included objective (range of motion, strength, clinical examinations, and imaging) and subjective (patient-reported outcomes, satisfaction, activities of daily living, and return to play) measures. RESULTS Of the 56 included studies, 43% documented range of motion, 14% reported strength, and 16% noted postoperative imaging. There was significant variation in use of patient-reported outcomes measures, with the 3 most commonly noted measures reported in 20% to 55% of studies. Return to play was noted in 75% of studies, and 23% reported time to return, with greater rates in elite athletes. Eleven studies (20%) did not report follow-up or noted data with <12 months of follow-up. CONCLUSIONS The SLAP literature is characterized by substantial variability in outcomes reporting, with time to return to play noted in few studies. Efforts to standardize outcomes reporting would facilitate comparisons across the literature and improve our understanding of the prognosis of this injury.

Clinical Evaluation and Physical Exam Findings in Patients with Anterior Shoulder Instability

Background: Hip arthroscopy for the treatment of intra-articular pathology is a rapidly expanding field. Outcome measures should be reported to document the efficacy of arthroscopic procedures; however, the most effective outcome measures are not established. Purpose: To evaluate the variability in outcomes reported after hip arthroscopy and to compare the responsiveness of patient-reported outcome (PRO) instruments. Study Design: Systematic review. Methods: We reviewed primary hip arthroscopy literature between January 2011 and September 2016 using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Patient and study characteristics were recorded. Pre- and postoperative means and SDs of PROs were recorded from articles that used 2 or more PROs with a 1-year minimum follow-up. From this subset of articles, we compared the responsiveness between PRO instruments using the effect size, standard response mean, and relative efficiency. Results: We identified 130 studies that met our inclusion/exclusion criteria, which totaled 16,970 patients (17,511 hips, mean age = 37.0 years, mean body mass index = 25.9 kg/m2). Radiographic measures were reported in 100 studies. The alpha angle and center-edge angle were the most common measures. Range of motion was reported in 81 of 130 articles. PROs were reported in 129 of 130 articles, and 21 different PRO instruments were identified. The mean number of PROs per article was 3.2, and 78% used 2 or more PROs. The most commonly used PRO was the modified Harris Hip Score, followed by the Hip Outcome Score (HOS)–Activities of Daily Living, HOS-Sport, visual analog scale, and Nonarthritic Hip Score (NAHS). The 2 most responsive PRO tools were the International Hip Outcome Tool (iHOT)–12 and the NAHS. Conclusion: Outcomes reporting is highly variable in the hip arthroscopy literature. More than 20 different PRO instruments have been used, which makes comparison across studies difficult. A uniform set of outcome measures would allow for clearer interpretation of the hip arthroscopy literature and offer potential conclusions from pooled data. On the basis of our comparative responsiveness results and previously reported psychometric properties of the different PRO instruments, we recommend more widespread adoption of the iHOT PROs instruments to assess hip arthroscopy outcomes.