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Postoperative PROMIS Scores from Sports Medicine Patients Randomized to Telehealth Virtual or In-Person Follow-Up
Jonathan G Wu1,2, Matthew T Muffly1,2, Amanda Sirisoma1,2
1Department of Orthopaedic Surgery, Los Angeles County, Harbor-UCLA Medical Center, Torrance, California, USA.
Background:
This randomized controlled trial compared the patient-reported outcome measures (PROMs) of patients who attended virtual telehealth visits with those of patients who attended in-person visits at their postoperative sports medicine appointments in a safety-net population. This is a parallel group trial with a 1:1 allocation ratio with a superiority framework.
Methods:
This trial enrolled 90 patients who received operative sports intervention at one clinic. The intervention group (48 patients) attended telehealth visits. The control group (42 patients) attended standard in-person visits. Primary outcomes were Patient-Reported Outcomes Measurement Information System (PROMIS) Global-Physical (GH-P) and PROMIS Global-Mental (GH-M) scores obtained at the 6-month visit. Welch's t-test and Pearson chi-square test analyses were utilized. Post hoc inverse probability weighting (IPW) analysis accounted for covariate imbalance. Statistical significance was based on an α level of 0.05. Post hoc adjustment of the α level was 0.013.
Results:
Eighty patients were included in the primary analysis. The telehealth group (45 patients) had a mean GH-P score 50.46 (standard deviation [SD] 7.84; 95% confidence interval [CI] [48.11-52.81]), whereas the in-person group (35 patients) had a mean score of 50.26 (SD 7.76; 95% CI [47.60-52.92]), with Δ = 0.20, p = 0.91, IPW-adjusted p = 0.59, with negligible effect (d = 0.03, 95% CI [-0.42 to 0.47]). For the GH-M score, the telehealth group had a mean 56.51 (SD 10.02; 95% CI [53.50-59.52]), and the in-person group had 60.21 (SD 8.47; 95% CI [57.30-63.12]), with Δ = 3.70, p = 0.08, IPW-adjusted p = 0.17, with small effect (d = -0.4, 95% CI [-0.85 to 0.05]). None of the score differences between the two groups were statistically significant.
Discussion:
This study lacks statistical evidence to state that there is a difference in PROMIS scores between the telehealth and in-person groups. The difference of the means between the two groups is less than the minimal clinically important difference obtained from the literature. Due to participant attrition, the study was underpowered. Limitations include retrospective registration of this trial, an increased risk of making a type 2 error, having 23% of telehealth participants cross over to the in-person group, conducting 71% of telehealth visits by video and 29% by phone, and completing surveys using different methods. These limitations are potential systematic errors that weaken the study's internal validity.
Level Of Evidence:
Level 1-prospective randomized controlled trial.