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Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study).

ABSTRACT: INTRODUCTION:There are several different interventions available to promote shared decision making (SDM); however, little is known about the comparative effectiveness of different approaches. OBJECTIVE:To examine the impact of patient-directed and physician-directed decision support strategies on the quality of treatment decisions for hip and knee osteoarthritis (OA). TRIAL DESIGN:A 2×2?factorial randomised controlled trial. SETTING:One academic medical centre, one community hospital and one orthopaedic specialty hospital. PARTICIPANTS AND INTERVENTIONS:The enrolment targets were 8 surgeons and 1120 patients diagnosed with hip or knee OA. Patients were randomly assigned to receive one of two different decision aids (DAs) stratified by site. The DAs varied in length, content and the level of detail regarding treatment options. Both DAs were available by paper or online.Surgeons were randomly assigned to receive a report detailing patients' goals and treatment preferences at the time of the visit or not. Eligible patients received their assigned DA before their visit and completed three surveys: before the visit (timepoint (T)1), 1-week postvisit (T2) and 6?months from either the visit date or surgery date for patients who underwent surgery (T3). Study staff and participating surgeons were not blinded, but the statistician conducting the analyses was blinded to the arms. MAIN OUTCOME MEASURE AND ANALYSIS:The primary study outcome was decision quality, the percentage of patients who were well informed and received their preferred treatment. Secondary outcomes included involvement in decision making, surgical rates, health outcomes, decision regret and satisfaction. A logistic regression model with the generalised estimating equations approach was used to compare rates of decision quality between the groups and account for the clustering of patients within providers. ETHICS AND DISSEMINATION:Ethics approval was obtained through the institutional review board at the main site. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT02729831; Pre-results.

SUBMITTER: Mangla M

PROVIDER: S-EPMC6443066 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study).

Mangla Mahima M Bedair Hany H Chang Yuchiao Y Daggett Susannah S Dwyer Maureen K MK Freiberg Andrew A AA Mwangi Sheila S Talmo Carl C Vo Ha H Sepucha Karen K

BMJ open 20190224 2

<h4>Introduction</h4>There are several different interventions available to promote shared decision making (SDM); however, little is known about the comparative effectiveness of different approaches.<h4>Objective</h4>To examine the impact of patient-directed and physician-directed decision support strategies on the quality of treatment decisions for hip and knee osteoarthritis (OA).<h4>Trial design</h4>A 2×2 factorial randomised controlled trial.<h4>Setting</h4>One academic medical centre, one c ...[more]

PMID: 30804032

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Project description:BACKGROUND:As guidelines and payers increasingly recommend use of patient decision aids (DAs), evidence about the comparative effectiveness of available DAs is critical for organizations interested in implementing them. The primary purpose of this study was to compare 2 DAs with regard to their ability to help patients become informed and receive their preferred treatment (that is, make an informed patient-centered decision), shared decision-making, surgical rates, and surgeon satisfaction. METHODS:We performed a multisite factorial randomized trial enrolling patients with hip or knee osteoarthritis. Patients were randomly assigned to use a long, detailed DA (long DA) or short, interactive DA (short DA). Eight surgeons were randomly assigned to receive a patient preference report detailing the patient's goals and treatment preferences or to administer usual care. RESULTS:We distributed 1,636 pre-visit surveys, 1,220 of which were returned (75% response rate), and 1,124 post-visit surveys, 967 of which were returned (86% response rate). The patients in the sample had a mean age (and standard deviation) of 65 ± 10 years, 57% were female, 89% were white non-Hispanic, and 67% had knee osteoarthritis. The majority (67.2%) made informed patient-centered decisions, and the rate did not vary significantly between the DA groups (p = 0.97) or between the surgeon groups (p = 0.23). Knowledge scores were higher for the short-DA group (mean difference = 9%; p < 0.001). More than half of the sample (60.5%) had surgery within 6 months after the visit, and rates did not differ significantly by DA or surgeon group. Overall, the surgeons were highly satisfied and reported that the majority (88.7%) of the visits were of normal duration or shorter. CONCLUSIONS:The DECIDE-OA study is, to our knowledge, the first randomized comparative effectiveness study of 2 orthopaedic DAs. The short DA outperformed the long DA with regard to knowledge scores and was comparable with respect to other outcomes. The surgeons reported high satisfaction and normal visit duration with both DAs. CLINICAL RELEVANCE:Surgeons need to ensure that patients with osteoarthritis are well-informed and have a clear preference regarding whether to undergo hip or knee replacement surgery. The DAs used in this study may help surgeons involve patients in elective surgery decisions and meet the requirements of informed consent.

Project description:BackgroundIn the past few decades, there has been an increasing focus on the importance of patient involvement in the health care system. Patient participation executed through patient-reported outcomes (PROs) and the integration of such into clinical practice has been framed as positive for patients, care providers, and the health care system as a whole. This review aims to elucidate and discuss the current and future use of PROs in clinical practice and to identify the most common types of PRO measures (PROMs) used for patients with hip or knee osteoarthritis in different treatment settings.MethodsThe following databases were searched: PubMed, Embase, CINAHL, Scopus, the Cochrane Library, and EconLit. For inclusion in the study, studies had to cover either knee or hip osteoarthritis and report on PROs. The type of PROM, treatment setting, and study design of each included study were extracted from their respective abstracts. Additionally, the full text of studies concerning PROs as an integrated part of clinical practice was examined and information on the year of publication, study design, topic, and use of PROMs was extracted.ResultsIt was found that only two pilot studies reported on the use of PROs as an integrated part of patient treatment within hip or knee osteoarthritis. In 349 studies, a total of 38 different PROMs relevant for patients with either hip or knee osteoarthritis were identified. The EQ-5D, WOMAC, and VAS questionnaires were the most commonly reported generic, disease-specific, and domain-specific PROMs, respectively. However, a large variation in the use of different PROMs both within and between surgical and nonsurgical settings was found.ConclusionLimited evidence on the use of PROs as an integrated part of clinical practice for patients with hip and knee osteoarthritis was found. Further research is necessary to clarify the effects on patient outcomes of using PROs in clinical practice. In addition, there is limited agreement on a joint standard for the use of PROMs both within and across the sectorial boarders. Further exploration of PROMs to generate future standardisation is suggested.

Project description:BackgroundYoung adults ages 18 to 25 with first episode psychosis (FEP) have an increased risk of discontinuation antipsychotic medications and psychiatric service disengagement that lead to symptom exacerbation and deterioration. We seek to (1) examine the feasibility, usability, and potential impact of a Shared Decision Making (SDM) Antipsychotic Medication Decision Aid (DA) on decision-making, adherence to the decision made, and service engagement among young adults with FEP and (2) understand the role of additional patient-level factors on SDM.MethodsA randomized controlled trial is being conducted in a coordinated specialty care community program for FEP in an urban setting. Eligible patients are randomly assigned to receive an intervention, the Antipsychotic Medication Decision Aid, or treatment as usual. Patients receive their assigned intervention before their medication appointment with the psychiatrist and complete four interviews: before the appointment (T0), after the appointment (T1), and at 3- and 6-month follow-ups (T2 and T3). The study staff and participating psychiatrists are not blinded to the intervention. The data are de-identified to maintain blinding during the analysis process. The primary aims are feasibility of intervention delivery and research procedures and preliminary impact of the intervention on SDM-related outcomes, medication adherence, and service engagement. As a secondary aim, we will explore the contribution of personality and motivation variables, clinical relationships, cognitive functioning, and mental-health-related stigma to SDM. If the sample size permits, we plan to conduct parametric tests such as independent-samples t tests at T1 to compare differences in SDM, adherence, and engagement scales. In the case of a small sample size, we will use non-parametric tests and descriptive statistics.DiscussionThis protocol outlines the methodology for a feasibility pilot comparing the effect of a novel SDM Antipsychotic Medication encounter DA with treatment as usual on SDM, medication adherence, and service engagement in FEP care. SDM is endorsed as a framework for use in FEP and antipsychotic pharmacotherapy, but its impact on adherence and health outcomes is unclear. Understanding the potential contribution of an SDM Antipsychotic Medication DA compared with usual care in psychosis pharmacotherapy is critical. The study will help answer several key questions new to SDM research, including the contribution of personality and clinical relationships to SDM in mental health and psychosis in particular. The study will serve to gather feasibility data to inform future studies and scale-up.Trial registrationEthics approval was obtained through Temple University's institutional review board (IRB) and the City of Philadelphia's Department of Public Health IRB. The study has been retrospectively registered with ClinicalTrials.gov as NCT04373590 on 29 April 2020. https://clinicaltrials.gov/ct2/show/NCT04373590?term=NCT04373590&draw=2&rank=1.

Project description:BackgroundSynovitis occurring frequently in osteoarthritis (OA) may be a targeted outcome. There are no data examining whether synovitis changes following intra-articular intervention.MethodsPersons aged 40 years and older with painful knee OA participated in an open label trial of intra-articular steroid therapy. At all time points they completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. They had a contrast-enhanced (CE) MRI immediately prior to an intra-articular steroid injection with a repeat scan within 20 days. Response status was assessed using the Osteoarthritis Research Society International (OARSI) response criteria. OARSI responders were followed until their pain relapsed either within 20% of baseline or 6 months, shortly after which a third MRI was performed. Synovial tissue volume (STV) was measured on postcontrast knee images. We looked at changes in the STV and in pain, and their association.Results120 subjects with preinjection and postinjection CE MRI were followed. Their mean age was 62.3 years (SD=10.3) and 62 (52%) were women. The median time between injection and follow-up scan was 8 days (IQR 7-14 days). 85/120 (71%) were OARSI responders. Pain decreased (mean change in KOOS=+23.9; 95% CI 20.1 to 27.8, p<0.001) following steroid injection, as did mean STV (mean change=-1071 mm(3); 95% CI -1839 mm(3) to -303 mm(3), p=0.01). Of the 80 who returned for a third MRI, pain relapsed in 57, and in the 48 of those with MRI data, STV increased between follow-up and final visit (+1220 mm(3); 95% CI 25 mm(3) to 2414 mm(3), p=0.05). 23 were persistent responders at 6 months and, in these, STV did not increase (mean change=-202 mm(3); 95% CI -2008 mm(3) to 1604 mm(3), p=0.83). Controlling for variation over time, there was a significant association between synovitis volume and KOOS pain (b coefficient-change in KOOS pain score per 1000 mm(3) change in STV=-1.13; 95% CI -1.87 to -0.39, p=0.003), although STV accounted for only a small proportion of the variance in change in pain.ConclusionsSynovial tissue volume in knee OA shrinks following steroid therapy, and rebounds in those whose pain relapses. It can be considered a treatment target in symptomatic knee OA.Trial registration numberISRCTN07329370.

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Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study).

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Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study).

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