Dataset Information

Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature.

ABSTRACT:

Background

It is not known, whether outcome reporting in trials of total joint arthroplasty in the recent years is adequate or not. Our objective was to assess whether outcomes reported in total joint replacement (TJR) trials fulfil the Outcome Measures in Rheumatology (OMERACT) Filter 2.0.

Methods

We systematically reviewed all TJR trials in adults, published in English in 2008 or 2013. Searches were conducted in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE. Two authors independently applied the inclusion criteria for the studies, and any disagreement was resolved with a third review author. All outcome measures were abstracted using a pre-piloted standardised data extraction form and assessed for whether they mapped to one of the three OMERACT Filter 2.0 core areas: pathophysiological, life impact, and death.

Results

From 1635 trials identified, we included 70 trials (30 in 2008 and 40 in 2013) meeting the eligibility criteria. Twenty-two (31%) trials reported the three essential OMERACT core areas. Among the 27 hip replacement surgery trials and 39 knee replacement surgery trials included, 11 hip (41%) and nine knee (23%) trials reported all three essential OMERACT core areas. The most common outcome domains/measures were pain (20/27, 74%) and function (23/27, 85%) in hip trials and pain (26/39, 67%) and function (27/39, 69%) in knee trials. Results were similar for shoulder and hand joint replacement trials.

Conclusions

We identified significant gaps in the measurement of OMERACT core outcome areas in TJR trials, despite the majority reporting outcome domains of pain and function. An international consensus of key stakeholders is needed to develop a core domain set for reporting of TJR trials.

Systematic review registration

PROSPERO CRD42014009216.

SUBMITTER: Wall PDH

PROVIDER: S-EPMC5450048 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Publications

Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature.

Wall Peter D H PDH Richards Bethan L BL Sprowson Andrew A Buchbinder Rachelle R Singh Jasvinder A JA

Systematic reviews 20170530 1

<h4>Background</h4>It is not known, whether outcome reporting in trials of total joint arthroplasty in the recent years is adequate or not. Our objective was to assess whether outcomes reported in total joint replacement (TJR) trials fulfil the Outcome Measures in Rheumatology (OMERACT) Filter 2.0.<h4>Methods</h4>We systematically reviewed all TJR trials in adults, published in English in 2008 or 2013. Searches were conducted in the Cochrane Central Register of Controlled Trials, MEDLINE, and EM ...[more]

PMID: 28558822

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Project description:ObjectiveTo determine whether the Comprehensive Care for Joint Replacement (CJR) model, a mandatory episode-based payment program for knee and hip replacement surgery, affected patient-reported measures of quality.Data sourcesSurveys of Medicare fee-for-service beneficiaries who had hip or knee replacement surgery, collected between July 2018 and March 2019, secondary Medicare administrative data, the Provider of Services file, CJR and Bundled Payments for Care Improvement participant lists from the Centers for Medicare & Medicaid Services, and the Area Health Resource Files.Study designIn 2018, participation in the CJR model was mandatory for nearly all hospitals in 34 randomly selected, metropolitan statistical areas (MSAs) that had high historical Medicare payments for lower-extremity joint replacements surgery. The control group included 47 high-payment MSAs randomly assigned as controls. We estimated risk-adjusted differences in self-reported measures of functional status and pain, satisfaction with care, and caregiver help between respondents in CJR hospitals and respondents in hospitals located in the control group.Data collectionWe selected a census of CJR patients and an equal number of control patients to survey. We fielded two waves of surveys using a mail and phone protocol, yielding 8433 CJR and 9014 control respondents.Principal findingsCJR respondents were slightly more likely to depend on caregivers for certain activities of daily living when they got home (either directly from the hospital or after an institutional post-acute care stay). On a 100-point scale, differences ranged from -2.6 points (p < 0.01) for help needed bathing to -1.7 points (p < 0.05) for help needed using the toilet. However, differences in eight measures of self-reported functional status approximately 90-120 days after hospital discharge were not statistically significant, ranging from -1.1% (p = 0.087) to 0.7% (p = 0.437).ConclusionsCJR did not harm patient health or affect patient satisfaction on average but did increase reliance on caregivers during recovery.

Project description:BackgroundKnee replacement is a very effective and indispensable treatment option for end-stage knee arthritis, and the number of cases has been increasing worldwide. A replaced knee joint without patient joint awareness is thought to be the ultimate goal of artificial knees. Joint awareness reportedly correlates with patient satisfaction. Although numbness around a replaced knee is a minor but common problem, its effect on postoperative outcome is controversial. Joint awareness also is sensitive to subtle abnormalities of the joint, so it must be negatively affected by numbness. Although numbness is minor, it cannot be ignored to further improve knee replacement outcomes. This study investigated the relationship between patient-reported numbness and other patient-reported outcome measures (PROMs), including joint awareness, and kneeling. We developed a numbness score based on a 5-point Likert scale on frequency of numbness, with an intraclass correlation coefficient of 0.76 and higher scores indicating less numbness.MethodsThe numbness score, New Knee Society Score (KSS), Knee Injury and Osteoarthritis Outcome Score (KOOS), Forgotten Joint Score-12 (FJS-12), and other clinical and radiological data from 311 patients (394 primary knee replacements) were analyzed. Kneeling ability was evaluated by using kneeling-specific items in the KSS (KSS-Kneeling).ResultsNo numbness was found in 170 knees (43.1%), and some degree of numbness was found in the remaining 224 knees (56.9%). The numbness score showed weak-to-moderate correlations with KSS-Symptoms (r = 0.44), KSS-Satisfaction (r = 0.41), KSS-Activities (r = 0.29), and all KOOS subscales (r = 0.23-0.44), and FJS-12 (r = 0.42). Multiple regression analyses suggested that midline incision positively affected the numbness score over the anteromedial incision (p = 0.04) and that a better numbness score (p = 0.001), male sex (p < 0.0001), and better postoperative knee flexion angle (0.04) positively affected kneeling.ConclusionsThe numbness score positively correlated with PROMs and positively affected kneeling. Knee replacements performed via an anteromedial incision may be at higher risk for numbness.

Project description:The volume of joint replacement surgery has risen steadily in recent years, because the population is aging and increasingly wishes to reserve a high functional status onward into old age. Infection is among the more common complications of joint replacement surgery, arising in 0.2% to 2% of patients, or as many as 9% in special situations such as the implantation of megaprostheses. The associated morbidity and mortality are high. It is thus very important to minimize risk factors for infection and to optimize the relevant diagnostic and therapeutic strategies.This review is based on pertinent publications retrieved by a selective search in PubMed, including current guidelines and expert recommendations.The crucial diagnostic step is joint biopsy for the identification of the pathogenic organism, which succeeds with over 90% sensitivity and specificity. If the prosthesis is firmly anchored in bone, the pathogen is of a type that responds well to treatment, and symptomatic infection has been present only for a short time, then rapidly initiated treatment can save the prosthesis in 35-90% of cases. The pillars of treatment are thorough surgical care (radical débridement) and targeted antibiotic therapy. On the other hand, if the prosthesis is loose or the pathogen is of a poorly treatable type, the infection can generally only be cured by a change of the prosthesis. This can be performed in either one or two procedures, always in conjunction with systemic antibiotic therapy tailored to the specific sensitivity and resistance pattern of the pathogen.The risk of infection of an artificial joint is low, but the overall prevalence of such infections is significant, as the number of implanted joints is steadily rising. Artificial joint infections should be treated by a standardized algorithm oriented toward the recommendations of current guidelines. Many of these recommendations, however, are based only on expert opinion, as informative studies providing high-grade evidence are lacking. Thus, for any particular clinical situation, there may now be multiple therapeutic approaches with apparently comparable efficacy. Randomized trials are urgently needed.

Dataset Information

Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature.

Background

Methods

Results

Conclusions

Systematic review registration

Publications

Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature.

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