83 research outputs found
Patient reported outcomes in orthopaedics
Patient reported outcome measures (PROMs) are key tools when performing clinical research and PROM data are increasingly used to inform clinical decision‐making, patient‐centered care, health policy and more recently, reimbursement decisions. PROMs must possess particular properties before they are used. Thus purpose of this paper is to give an overview of PROMs, their definition, how their evidence can be assessed, how they should be reported in clinical research, how to choose PROMs, the types of PROMs available in orthopaedics, where these measures can be found, PROMs in orthopaedic clinical practice and what are some key next steps in this field. If PROMs are used in accordance with the guidance in this article, I believe we will gain considerable insight into PROMs in orthopaedics and will advance this field in a way that can contribute to science, improve patient care and save considerable resources. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:2098–2108, 2017.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/138935/1/jor23604_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/138935/2/jor23604.pd
Herbal therapy for treating rheumatoid arthritis (review)
Background
Herbal medicine interventions have been identified as having potential benefit in the treatment of rheumatoid arthritis (RA).
Objectives
To update an existing systematic (Cochrane) review of herbal therapies in RA.
Search methods
We searched electronic databases Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, AMED, CINAHL, Web of Science, Dissertation Abstracts (1996 to 2009), unrestricted by language, and the WHO International Clinical Trials Registry Platform in October 2010.
Selection criteria
Randomised controlled trials of herbal interventions compared with placebo or active controls in RA.
Data collection and analysis
Two authors selected trials for inclusion, assessed risk of bias and extracted data.
Main results
Twelve new studies were added to the update, a total of 22 studies were included.
Evidence from seven studies indicate potential benefits of gamma linolenic acid (GLA) from evening primrose oil, borage seed oil, or blackcurrent seed oil, in terms of reduced pain intensity (mean difference (MD) ‐32.83 points, 95% confidence interval (CI) ‐56.25 to ‐9.42,100 point pain scale); improved disability (MD ‐15.75% 95% CI ‐27.06 to ‐4.44%); and an increase in adverse events (GLA 20% versus placebo 3%), that was not statistically different (relative risk 4.24, 95% CI 0.78 to 22.99).
Three studies compared Tripterygium wilfordii (thunder god vine) to placebo and one to sulfasalazine and indicated improvements in some outcomes, but data could not be pooled due to differing interventions, comparisons and outcomes. One study reported serious side effects with oral Tripterygium wilfordii Hook F. In the follow‐up studies, all side effects were mild to moderate and resolved after the intervention ceased. Two studies compared Phytodolor® N to placebo but poor reporting limited data extraction. The remaining studies each considered differing herbal interventions.
Authors' conclusions
Several herbal interventions are inadequately justified by single studies or non‐comparable studies in the treatment of rheumatoid arthritis. There is moderate evidence that oils containing GLA (evening primrose, borage, or blackcurrant seed oil) afford some benefit in relieving symptoms for RA, while evidence for Phytodolor® N is less convincing.Tripterygium wilfordii products may reduce some RA symptoms, however, oral use may be associated with several side effects. Many trials of herbal therapies are hampered by research design flaws and inadequate reporting. Further investigation of each herbal therapy is warranted, particularly via well designed, fully powered, confirmatory clinical trials that use American College of Rheumatology improvement criteria to measure outcomes and report results according to CONSORT guidelines
Measures of Adult Knee Function
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/163466/2/acr24235_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/163466/1/acr24235.pd
Efficacy of acupuncture for cocaine dependence: a systematic review & meta-analysis
BACKGROUND: Acupuncture is a commonly used treatment option for the treatment of addictions such as alcohol, nicotine and drug dependence. We systematically reviewed and meta-analyzed the randomized controlled trials of acupuncture for the treatment of cocaine addiction. METHODS: Two reviewers independently searched 10 databases. Unpublished studies were sought using Clinicaltrials.gov, the UK National Research Register and contacting content experts. Eligible studies enrolled patients with the diagnosis of cocaine dependence of any duration or severity randomly allocated to either acupuncture or sham or other control. We excluded studies of acupuncture methods and trials enrolling patients with polysubstance use or dependence. We abstracted data on study methodology and outcomes. We pooled the studies providing biochemical confirmation of cocaine abstinence. RESULTS: Nine studies enrolling 1747 participants met inclusion criteria; 7 provided details for biochemical confirmation of cocaine abstinence. On average, trials lost 50% of enrolled participants (range 0–63%). The pooled odds ratio estimating the effect of acupuncture on cocaine abstinence at the last reported time-point was 0.76 (95% CI, 0.45 to 1.27, P = 0.30, I(2 )= 30%, Heterogeneity P = 0.19). CONCLUSION: This systematic review and meta-analysis does not support the use of acupuncture for the treatment of cocaine dependence. However, most trials were hampered by large loss to follow up and the strength of the inference is consequently weakened
Measures of Hip Function and Symptoms
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/163446/2/acr24231_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/163446/1/acr24231.pd
Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders:a modified Delphi study
Objective: To achieve consensus on the most important outcome domains to measure across all clinical trials for shoulder disorders. Methods: We performed an online modified Delphi study with an international, multidisciplinary and multistakeholder panel. A literature review and the OMERACT Filter 2.0 framework was used to generate a list of potential core domains, which were presented to patients, clinicians and researchers in two Delphi rounds. Participants were asked to judge the importance of each potential core domain and provide a rationale for their response. A core domain was defined a priori as a domain that at least 67% of participants considered core. Results: In both rounds, 335 individuals were invited to participate (268 clinicians/researchers and 67 patients); response rates were 27% (n=91) and 29% (n=96), respectively. From a list of 41 potential core domains, four domains met our criteria for inclusion: 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life'. Two additional domains, 'sleep functioning' and 'psychological functioning', met the criteria for inclusion by some, but not all stakeholder groups. There was consensus that 'number of deaths' was not a core domain, but insufficient agreement on whether or not several other domains, including 'range of motion' and 'muscle strength', were core domains. Conclusions: Based on international consensus from patients, clinicians and researchers, 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life' were considered core outcome domains for shoulder disorder trials. The value of several other domains needs further consideration
Outcome Reporting in Randomized Trials for Shoulder Disorders: Literature Review to Inform the Development of a Core Outcome Set
Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/141827/1/acr23254_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/141827/2/acr23254.pd
A retrospective cohort study of adverse events in patients undergoing orthopaedic surgery
Abstract
Background
This study’s objective was to identify adverse events following common orthopaedic procedures, and to estimate the incidence rates and risks of these events and their associations with age, sex, and comorbidities.
Methods
This retrospective cohort study manually reviewed and extracted electronic medical data on the incidence and predictors of adverse events that occurred within 90 days of the 50 most frequent orthopaedic surgeries at an academic hospital in 2010. We also extracted demographic data, baseline comorbidities, and duration of follow-up (≤90 days). Patients were scored on the Charlson Comorbidity Index (CCI) and the Functional Comorbidity Index (FCI). We estimated incidence rates and risks for all events and associations using regression methods. Prolonged pain 42-days post-surgery was treated as a separate outcome.
Results
We included 1,552 patients; average age was 53.4 years, and 51.7% were female. A total of 1,148 adverse events were identified in 729 patients. The incidence rate of all adverse events was 10 events per 1,000 person-days at risk; 47% of all patients experienced at least one adverse event within 90 days. The most frequent events were prolonged pain (31% of all adverse events) and persistent swelling (7%). We found positive associations between both comorbidity scores and the incidence rate and 90-day risk of all adverse events, excluding pain, adjusting for age and sex (neither of which was associated with adverse events); the association was stronger for the FCI than for the CCI. For total hip arthroplasty (THA) and total knee arthroplasty (TKA), the incidence rate of all adverse events, excluding pain, was positively associated with both comorbidity scores and age; the 90-day risk was positively associate with the FCI score and male sex. The prevalence of prolonged pain at 42 days was greater in patients with higher FCI scores; for THA and TKA only, pain prevalence was greater in those with higher FCI scores and in men.
Conclusions
Adverse events are frequent following common orthopaedic procedures. The incidence is greatest for patients with more functional comorbidities. For THA and TKA procedures, being male and being older are also associated with a greater incidence of adverse events.https://deepblue.lib.umich.edu/bitstream/2027.42/136771/1/13037_2017_Article_129.pd
The CARE guidelines: consensus-based clinical case reporting guideline development
Abstract
Background
A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design.
Primary Objective. Develop, disseminate, and implement systematic reporting guidelines for case reports.
Methods
We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines.
Results
This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent.
Conclusions
We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery.http://deepblue.lib.umich.edu/bitstream/2027.42/112624/1/13256_2013_Article_2617.pd
Measures of Adult Shoulder Function
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/163413/2/acr24230.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/163413/1/acr24230_am.pd
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