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Substantial clinical benefit, responsiveness, and sensitivity to change of three common outcome measures following shoulder arthroplasty

ABSTRACT: Objectives: It is important for clinicians involved in the care of patients with advanced glenohumeral osteoarthritis to determine clinically significant change when using outcome measures. There is little information on the amount of substantial clinical benefit in shoulder outcomes after shoulder arthroplasty. The purpose of this study was twofold: (1) to quantify substantial clinical benefit for the American Shoulder and Elbow Surgery score, the Constant Murley Score, and the Western Ontario Osteoarthritis of the Shoulder index and (2) to provide estimates of responsiveness and sensitivity to change for these measures following shoulder arthroplasty. Methods: The study involved a secondary analysis of previously collected data. The substantial clinical benefit and responsiveness of the measures were calculated based on external anchors related to change in pain, range of motion, and ability to carry out activities of daily living. The areas under curve and standardized response mean represented responsiveness and sensitivity to change. Results: The data of 159 and 131 patients with complete follow-up at 6?months and 2?years were reviewed. The amount of substantial clinical benefit was dependent on the outcome measure and the external anchor and increased for all measures from 6?months to 2?years. Responsiveness was high (areas under curve?>?0.80) at 6?months and further improved at 2?years (areas under curve?>?0.88). The standardized response mean values of both time points were over 2.00, indicating high effect sizes. The standardized response means of the Constant Murley Score were statistically significantly higher than the standardized response means of the American Shoulder and Elbow Surgery and Western Ontario Osteoarthritis of the Shoulder. Conclusion: Amount of substantial clinical improvement in pain, range of motion, and activities of daily living following shoulder arthroplasty depends on the type of outcome measure used. All three measures, the American Shoulder and Elbow Surgery, absolute and relative Constant Murley Score, and Western Ontario Osteoarthritis of the Shoulder, demonstrated good to excellent accuracy and optimal standardized response means. Level of evidence: Level III, Retrospective Cohort study

SUBMITTER: Razmjou H

PROVIDER: S-EPMC7385837 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:BackgroundImpaired balance has a significant negative impact on mobility, functional independence, and fall risk in older adults. Although several, well-respected balance measures are currently in use, there is limited evidence regarding the most appropriate measure to assess change in community-dwelling older adults.ObjectiveThe aim of this study was to compare floor and ceiling effects, sensitivity to change, and responsiveness across the following balance measures in community-dwelling elderly people with functional limitations: Berg Balance Scale (BBS), Performance-Oriented Mobility Assessment total scale (POMA-T), POMA balance subscale (POMA-B), and Dynamic Gait Index (DGI).DesignRetrospective data from a 16-week exercise trial were used. Secondary analyses were conducted on the total sample and by subgroups of baseline functional limitation or baseline balance scores.MethodsParticipants were 111 community-dwelling older adults 65 years of age or older, with functional limitations. Sensitivity to change was assessed using effect size, standardized response mean, and paired t tests. Responsiveness was assessed using minimally important difference (MID) estimates.ResultsNo floor effects were noted. Ceiling effects were observed on all measures, including in people with moderate to severe functional limitations. The POMA-T, POMA-B, and DGI showed significantly larger ceiling effects compared with the BBS. All measures had low sensitivity to change in total sample analyses. Subgroup analyses revealed significantly better sensitivity to change in people with lower compared with higher baseline balance scores. Although both the total sample and lower baseline balance subgroups showed statistically significant improvement from baseline to 16 weeks on all measures, only the lower balance subgroup showed change scores that consistently exceeded corresponding MID estimates.LimitationsThis study was limited to comparing 4 measures of balance, and anchor-based methods for assessing MID could not be reported.ConclusionsImportant limitations, including ceiling effects and relatively low sensitivity to change and responsiveness, were noted across all balance measures, highlighting their limited utility across the full spectrum of the community-dwelling elderly population. New, more challenging measures are needed for better discrimination of balance ability in community-dwelling elderly people at higher functional levels.

Project description:BackgroundThe number of hip, knee and shoulder arthroplasties continues to rise worldwide. The Organization for Economic Cooperation and Development has launched an initiative (called PaRIS Initiative) for the systematic collection of Patient Reported Outcome Measures (PROMs) in patients undergoing elective hip and knee arthroplasty. The Rizzoli Orthopedic Institute (IOR) was selected as a pilot center for the launch of the Initiative in Italy given that IOR hosts the Registry of Orthopedic Prosthetic Implants (RIPO), a region-wide registry which collects joint implant data from all the hospitals in the Emilia-Romagna Region. In this specific geographic area information related to PROMs after joint replacement is unknown. This paper describes the protocol of a study (PaRIS-IOR) that aims to implement the collection of a set of PROMs within an existing implant registry in Italy. The study will also investigate the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention.MethodsThe PaRIS-IOR study is a prospective, single site, cohort study that consists of the administration of PROMs questionnaires to patients on the list for elective arthroplasty. The questionnaires will be administered to the study population within 30 days before surgery, and then at 6 and 12 months following surgery. The study population will consist of consecutive adult patients undergoing either hip, knee or shoulder arthroplasty. The collected data will be linked with those routinely collected by the RIPO in order to assess the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention.DiscussionThe PaRIS-IOR study could have important implications in targeting the factors influencing functional outcomes and quality of life reported by patients after hip, knee and shoulder arthroplasty, and will also represent the first systematic collection of PROMs related to arthroplasty in Italy.Trial registrationProtocol version (1.0) and trial registration data are available on the platform www.clinicaltrial.gov with the identifier NCT03790267 , first posted on December 31, 2018.

Project description:BackgroundResponsiveness, or sensitivity to clinical change, is important when selecting patient-reported outcome measures (PROMs) for research and clinical applications. This study compares responsiveness of PROMs used in chronic rhinosinusitis (CRS) to inform the future development of a highly responsive instrument that accurately portrays CRS patients' symptom experiences.MethodsAdult CRS patients initiating medical therapy (MT; n = 143) or undergoing endoscopic sinus surgery after failing MT (ESS; n = 123) completed the 22-item Sino-Nasal Outcome Test (SNOT-22), European Position Statement on Rhinosinusitis (EPOS) visual analog scale (VAS), and 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) at baseline and 3 months after treatment. Cohen's d and paired t statistics were used to evaluate the responsiveness of each measure.ResultsFifty-two (36.4%) subjects and 42 (34.1%) subjects in the MT and ESS groups, respectively, completed baseline and 3-month questionnaires. Subjects with and without 3-month data were similar with respect to baseline demographics, VAS scores, and SNOT-22 scores (p > 0.05). In MT patients, CRS-specific measures, like VAS (d = -0.58, p < 0.01; t = -1.81, p > 0.05) and SNOT-22 (d = -0.70, p < 0.01; t = -3.29, p < 0.05) scores, were more responsive than PROMIS-29 general health domains (p > 0.05 for Cohen's d). In ESS patients, VAS (d = -1.97; t = -9.63, both p < 0.01) and SNOT-22 (d = -1.56; t = -9.99, both p < 0.01) scores were similarly more responsive, although changes in PROMIS-29 domains of Fatigue (d = -0.82, p = 0.01; t = -4.63, p < 0.01), Sleep Disturbance (d = -0.83; t = -3.77, both p < 0.01), and Pain Intensity (d = -1.0; t = -5.67, both p < 0.01) were significant. All 22 individual SNOT-22 items differed significantly after surgery, whereas only 8 items were consistently responsive after MT.ConclusionsFor both MT and ESS patients, CRS-specific PROMs are more responsive to posttreatment clinical changes than general health measures. Still, the SNOT-22 contains items that likely decrease its overall responsiveness. Our findings also indicate that existing PROMs had a greater response to ESS than MT.

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Substantial clinical benefit, responsiveness, and sensitivity to change of three common outcome measures following shoulder arthroplasty

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