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

Risk of bias of randomized controlled trials published in orthopaedic journals

BACKGROUND: The purpose of this study was to assess the quality of methodology in orthopaedics-related randomized controlled trials (RCTs) published from January 2006 to December 2010 in the top orthopaedic journals based on impact scores from the Thompson ISI citation reports (2010). METHODS: Journals included American Journal of Sports Medicine; Journal of Orthopaedic Research; Journal of Bone and Joint Surgery, American; Spine Journal; and Osteoarthritis and Cartilage. Each RCT was assessed on ten criteria (randomization method, allocation sequence concealment, participant blinding, outcome assessor blinding, outcome measurement, interventionist training, withdrawals, intent to treat analyses, clustering, and baseline characteristics) as having empirical evidence for biasing treatment effect estimates when not performed properly. RESULTS: A total of 232 RCTs met our inclusion criteria. The proportion of RCTs in published journals fell from 6% in 2006 to 4% in 2010. Forty-nine percent of the criteria were fulfilled across these journals, with 42% of the criteria not being amendable to assessment due to inadequate reporting. The results of our regression revealed that a more recent publication year was significantly associated with more fulfilled criteria (β = 0.171; CI = −0.00 to 0.342; p = 0.051). CONCLUSION: In summary, very few studies met all ten criteria. Thus, many of these studies likely have biased estimates of treatment effects. In addition, these journals had poor reporting of important methodological aspects

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

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

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

Impact of Exercise in Community-Dwelling Older Adults

Background: Concern has been expressed that preventive measures in older people might increase frailty by increasing survival without improving health. We investigated the impact of exercise on the probabilities of health improvement, deterioration and death in community-dwelling older people. Methods and Principal Findings: In the Canadian Study of Health and Aging, health status was measured by a frailty index based on the number of health deficits. Exercise was classified as either high or low/no exercise, using a validated, selfadministered questionnaire. Health status and survival were re-assessed at 5 years. Of 6297 eligible participants, 5555 had complete data. Across all grades of frailty, death rates for both men and women aged over 75 who exercised were similar to their peers aged 65 to 75 who did not exercise. In addition, while all those who exercised had a greater chance of improving their health status, the greatest benefits were in those who were more frail (e.g. improvement or stability was observed in 34 % of high exercisers versus 26 % of low/no exercisers for those with 2 deficits compared with 40 % of high exercisers versus 22 % of low/no exercisers for those with 9 deficits at baseline). Conclusions: In community-dwelling older people, exercise attenuated the impact of age on mortality across all grades of frailty. Exercise conferred its greatest benefits to improvements in health status in those who were more frail at baseline