Faith Selzer

Background: Clinician equipoise—indifference between treatment arms—provides an ethical foundation for clinician participation in randomized controlled trials (RCTs). In preparation for an RCT comparing arthroscopic partial meniscectomy versus enhanced nonoperative therapy for patients with a meniscal tear and knee osteoarthritis (OA) who remain symptomatic after a course of physical therapy, we conducted a mixed-methods study to assess equipoise among potential enrolling clinicians. Methods: Fifteen clinicians with experience managing meniscal tears assessed 29 vignettes of hypothetical patients who met trial eligibility criteria. We randomly varied 13 vignette features (e.g., age, sex, radiographic severity, tear morphology). Clinicians expressed their willingness to enroll each hypothetical patient. After polling, we recorded and transcribed a moderated discussion to document clinician thought processes. We performed a quantitative analysis to identify clinical features associated with the likelihood of enrollment and an exploratory thematic analysis of the transcribed discussion to explicate the quantitative findings. Results: The 15 orthopaedic surgeons and physician assistants assessed 29 vignettes describing hypothetical patients. Eight votes were missing, leaving 427 vignettes, of which the clinicians were willing to enroll 302 (71%) (range, 24% to 100%) in the trial. Three clinicians were willing to enroll <50% of vignettes. Clinicians were willing to enroll just 39% of vignettes with bucket-handle tears. In logistic regression analyses, a bucket-handle tear (adjusted odds ratio [aOR], 0.12; 95% confidence interval [CI], 0.04 to 0.37) and Kellgren-Lawrence 3 radiographs (aOR, 0.54; 95% CI, 0.36 to 0.82) were independently associated with clinician unwillingness to randomize. The qualitative analysis confirmed that clinicians believed that bucket-handle tears should be managed operatively, whereas combinations of greater age, severe OA, inability to walk 200 yards, and higher body mass index (BMI) pushed clinicians toward nonoperative therapy. Conclusions: This methodology can be used to identify clinicians who should be engaged in discussions and interventions to support equipoise. It can also inform development of exclusion criteria (e.g., exclude bucket-handle tears) to increase the proportion of eligible subjects referred for enrollment. Clinical Relevance: Orthopedic surgeons play crucial roles in randomized controlled trials, the foundation of clinical practice guidelines, by enrolling patients from their practices. This article examines clinician equipoise, a key determinant of the willingness of clinicians to enroll eligible patients in trials.

Background: Knee osteoarthritis (OA) is prevalent and often associated with meniscal tear. Physical therapy (PT) and exercise regimens are often used to treat OA or meniscal tear, but, to date, few programs have been designed specifically for conservative treatment of meniscal tear with concomitant knee OA. Clinical care and research would be enhanced by a standardized, evidence–based, conservative treatment program and the ability to study the effects of the contextual factors associated with interventions for patients with painful, degenerative meniscal tears in the setting of OA. This paper describes the process of developing both a PT intervention and a home exercise program for a randomized controlled clinical trial that will compare the effectiveness of these interventions for patients with knee pain, meniscal tear and concomitant OA. Methods: This paper describes the process utilized by an interdisciplinary team of physical therapists, physicians, and researchers to develop and refine a standardized in-clinic PT intervention, and a standardized home exercise program to be carried out without PT supervision. The process was guided in part by Medical Research Council guidance on intervention development. Results: The investigators achieved agreement on an in-clinic PT intervention that included manual therapy, stretching, strengthening, and neuromuscular functional training addressing major impairments in range of motion, musculotendinous length, muscle strength and neuromotor control in the major muscle groups associated with improving knee function. The investigators additionally achieved agreement on a progressive, protocol-based home exercise program (HEP) that addressed the same major muscle groups. The HEP was designed to allow patients to perform and progress the exercises without PT supervision, utilizing minimal equipment and a variety of methods for instruction. Discussion: This multi-faceted in-clinic PT program and standardized HEP provide templates for in-clinic and home-based care for patients with symptomatic degenerative meniscal tear and concomitant OA. These interventions will be tested as part of the Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial. Trial registration: The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 on February 14, 2017. TeMPO was also approved by the Institutional Review Board at Partners HealthCare/Brigham and Women’s Hospital.

Meniscal tears often accompany knee osteoarthritis, a disabling condition affecting 14 million individuals in the United States. While several randomized controlled trials have compared physical therapy to surgery for individuals with knee pain, meniscal tear, and osteoarthritic changes (determined via radiographs or magnetic resonance imaging), no trial has evaluated the efficacy of physical therapy alone in these subjects. The Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial is a four-arm multi-center randomized controlled clinical trial designed to establish the comparative efficacy of two in-clinic physical therapy interventions (one focused on strengthening and one containing placebo) and two protocolized home exercise programs. The goal of this paper is to present the rationale behind TeMPO and describe the study design and implementation strategies, focusing on methodologic and clinical challenges. The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 . on February 14, 2017.