Interpreting Patient-Reported Outcome Measures in Orthopaedic Surgery

Abstract

Background: The Consolidated Standards of Reporting Trials (CONSORT) Statement recommends that studies report results beyond p values and include treatment effect(s) and measures of precision (e.g., confidence intervals [CIs]) to facilitate the interpretation of results. The objective of this systematic review was to assess the reporting and interpretation of patient-reported outcome measure (PROM) results in clinical studies from high-impact orthopaedic journals, to determine the proportion of studies that (1) only reported a p value; (2) reported a treatment effect, CI, or minimal clinically important difference (MCID); and (3) offered an interpretation of the results beyond interpreting a p value. Methods: We included studies from 5 high-impact-factor orthopaedic journals published in 2017 and 2019 that compared at least 2 intervention groups using PROMs. Results: A total of 228 studies were analyzed, including 126 randomized controlled trials, 35 prospective cohort studies, 61 retrospective cohort studies, 1 mixed cohort study, and 5 case-control studies. Seventy-six percent of studies (174) reported p values exclusively to express and interpret between-group differences, and only 22.4% (51) reported a treatment effect (mean difference, mean change, or odds ratio) with 95% CI. Of the 54 studies reporting a treatment effect, 31 interpreted the results using an important threshold (MCID, margin, or Cohen d), but only 3 interpreted the CIs. We found an absolute improvement of 35.5% (95% CI, 20.8% to 48.4%) in the reporting of the MCID between 2017 and 2019. Conclusions: The majority of interventional studies reporting PROMs do not report CIs around between-group differences in outcome and do not define a clinically meaningful difference. A p value cannot effectively communicate the readiness for implementation in a clinical setting and may be misleading. Thus, reporting requirements should be expanded to require authors to define and provide a rationale for between-group clinically important difference thresholds, and study findings should be communicated by comparing CIs with these thresholds.

Russian versions of FADI and FAAM for preoperative and postoperative assessment of the foot function

“…ОБСУЖДЕНИЕ В настоящее время опросники, которые заполняют сами пациенты, широко применяют для комплексной оценки нарушений функции стопы и голеностопного сустава (лодыжки) и связанных с ними ограничений у пациентов ортопедического профиля [7]. Показана их информативность и полезность при определении эффективности хирургического лечения и реабилитации [2,3]. Наиболее распространенными инструментами, которые рекомендованы международным ортопедическим сообществом для оценки состояния стопы и/или голеностопного сустава, в том числе при проведении хирургического лечения, являются опросники FADI и FAAM [12].…”

“…При определении результатов хирургического лечения пациентов ортопедического профиля, наряду с клиническими данными, важным является учет мнения самого пациента в отношении влияния патологии опорно-двигательного аппарата на его ежедневную активность и качество жизни [1,2]. Положение о целесообразности проведения пациентом самооценки своего состояния при определении эффекта лечения включено в международные рекомендации по ведению пациентов с нарушениями опорно-двигательного аппарата [3]. Нарушения функции стопы и голеностопного сустава (лодыжки) и связанные с ними ограничения могут быть оценены пациентом с помощью специально разработанных опросников [4].…”

Patient-Reported Outcome Measurement and Minimal Clinically Important Difference for Hand Surgeons

“…A P -value alone is inadequate for interpreting study findings, nor is it adequate for changing clinical practice and, in isolation, can be misleading. 21 For this reason, values such as the minimal clinically important difference (MCID), SCB, and patient acceptable symptom state (PASS) are used to help interpret patients' responses to treatment as detected by a PRO tool. MCID and SCB allow one to evaluate an outcome score, such as a visual analog pain score (VAS-pain), and provide a threshold value that indicates whether a patient or population has experienced a clinically relevant change in their score.…”

Preoperative factors associated with failure to reach the patient acceptable symptom state after anterior cruciate ligament reconstruction in patients aged 40 and older

“…Validated PROMs provide valuable insight to longitudinal changes in patient’s perceived pain and function following ACL injuries but assessing changes in terms of statistical significance provides little context and meaning to patients and providers as each patient case is unique [12, 15, 28]. The establishment of clinically relevant thresholds for PROMs, addresses this limitation.…”