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Peter Tugwell

Publications and source records attributed to Peter Tugwell.

At least 55 records · Page 3Linked to original sources

Efficacy of continuous passive motion following total knee arthroplasty: a metaanalysis.

OBJECTIVE: The objective of this metaanalysis is to examine the effectiveness of continuous passive motion (CPM) following total knee arthroplasty (TKA). METHODS: This metaanalysis used the methodology proposed by the Cochrane Collaboration. RESULTS: This review of 14 studies (952 patients) found significant improvements in active knee flexion and analgesic use 2 weeks postoperatively with the use of CPM and physiotherapy (PT) compared to PT alone. In addition, length of hospital stay and need for knee manipulations were significantly decreased in the CPM group. Not enough data were available to compare the degree of knee flexion applied or number of hours of application of CPM. However, significant results were not found for other comparisons such as short term CPM application versus longterm CPM application and wide treatment range versus small treatment range for the outcomes of active knee flexion, passive knee flexion and extension, presence of a fixed flexion deformity, use of analgesic, or total knee range of motion. CONCLUSION: CPM combined with PT may offer beneficial results for patients post-TKA. However, the potential benefits will need to be carefully weighed against the inconvenience and expense of CPM. More research is necessary to assess the differences in effectiveness with different characteristics of application such as total duration of treatment and intensity of CPM interventions.

Arthritis, Rheumatoid↗

The use of rheumatoid arthritis health-related quality of life patient questionnaires in clinical practice: lessons learned.

OBJECTIVE: The utilization of health-related quality of life (HRQOL) patient questionnaires by clinical rheumatologists is limited. Yet, considerable literature exists defining the value of such data. In an effort to understand this apparent paradox, we performed a literature review and conducted a survey to describe what has been learned over the past 2 decades concerning the use of these measures in clinical care and explore the reasons for their underutilization. METHODS: A panel of rheumatologists with extensive clinical experience was convened to review the relevant literature pertaining to the use of HRQOL patient instruments in clinical practice. Additionally, a survey of all American College of Rheumatology practicing clinicians was conducted to assess the use of and beliefs about these measures. RESULTS: The literature provided evidence to support the use of HRQOL patient measures in clinical practice. Forty-seven percent of the responding rheumatologists stated that none of their patients complete HRQOL patient questionnaires. The majority of respondents (63%) reported that such information is "somewhat valuable." The most frequently reported reason for the underutilization was that such instruments "require too much staff time." CONCLUSIONS: The literature supports the potential value of HRQOL patient questionnaires in clinical practice. Few rheumatologists routinely gather such information as part of patient care. Reasons for this discrepancy between utility and use are given along with recommendations intended to help increase their utilization in clinical care.

Arthritis, Rheumatoid↗

A qualitative study of physicians' perceptions of three decision aids.

The study objective was to investigate physicians' perceptions of three patient decision aids (DA). Semi-structured telephone interviews were conducted with 20 family physicians and 12 gynecologists about a DA for women considering long-term hormone replacement therapy; with 16 respirologists about a DA for the use of intubation and mechanical ventilation for patients with severe chronic obstructive pulmonary disease; and with 19 physicians (geriatricians, gastroenterologists, internists) about a DA for long-term placement of feeding tubes in the elderly. Participants were identified by a snowball sampling technique. The interviews were analyzed using standard qualitative methods. Most participants (81%) indicated some willingness to use the DAs. The characteristics of the DA viewed positively included it being: balanced, well organized, a useful tool, evidence-based, improves decision making process and multimedia. Some of the negative characteristics were stated as: too complex, the cost, the availability, only appropriate for certain groups of patients, and time consuming. The DAs were acceptable to most participants. Perceived positive and negative factors were similar for all DAs. Uptake of decision aids may be facilitated if physicians have an opportunity to examine and try them, and if they can have unfettered access to them for distribution purposes.

Attitude of Health Personnel↗

A survey of the decision-making needs of Canadians faced with complex health decisions.

OBJECTIVE: To describe the decision-making needs of Canadians when faced with 'complex' health decisions characterized by balancing advantages against disadvantages. Although a national report emphasized that public confidence in the health-care system depends on support for personal knowledge and decision-making, there has been no systematic investigation of the Canadian population's decision-making needs. DESIGN: Cross-sectional telephone survey using random digit dialling. PARTICIPANTS: National sample of 635 adults over 18 years of age, living in Canada. RESULTS: Forty-two percentage of eligible contacts participated. Sixty-five percent of contacts reported making 'complex' health decisions, commonly about medical or surgical treatments or birth control, and more commonly by women and by married/separated individuals. Most respondents took an active role in their decisions, often sharing the process with their partner or family. Being younger was associated with a more independent role. Physicians were more often involved in the decisions of respondents with less education. Fifty-nine percent of respondents experienced decisional conflict; more conflict was seen with those who were female and feeling uninformed about options, pressured to select one particular option, and unready or unskilled in decision-making. Less decisional conflict was seen in those who reported birth control decisions and in those who were 70 years and older. Participants used several strategies when deliberating about choices including: information gathering, clarifying their values, and seeking support and information from others. Personal counselling and printed information materials were commonly preferred methods of learning about options. 'Essential' criteria for judging satisfactory decision-making included: having sufficient knowledge about the options, outcomes, and probabilities; being clear about values; selecting and implementing a choice that agrees with personal values; and expressing satisfaction with the choice. CONCLUSIONS: Canadians, particularly women, face difficult decisions and need support and information from credible sources.

Adolescent↗

Economic evaluation of norethisterone acetate/ethinylestradiol (FemHRT) for women with menopausal symptoms.

INTRODUCTION: The objective of this study was to assess the cost effectiveness of a continuous combined oral preparation of norethisterone (norethindrone) acetate and ethinylestradiol (NA/EE) [FemHRT] as both a first-line and second-line therapy for menopausal women. PERSPECTIVE: Third-party payer. METHODS: The cost effectiveness of NA/EE was assessed as both a first- and second-line therapy in comparison with conjugated equine oestrogen 0.625mg and medroxyprogesterone acetate 2.5mg (CEE/MPA) and no therapy. Analysis was conducted within a Markov model with states relating to the presence and absence of vaginal bleeding, menopausal symptoms and hip fracture. Analysis forecasted life expectancy, QALYs and lifetime costs for a 50-year-old menopausal woman. Compliance was modelled related to menopausal symptoms and vaginal bleeding. For the base-case analysis, it was assumed that compliant women would take therapy for up to 5 years. Sensitivity analysis assumed therapy was taken only for 1 year. RESULTS: Compared with both CEE/MPA and no therapy, NA/EE led to an increase in both costs and QALYs, both as a first- and second-line therapy. For first-line therapy, the incremental cost per QALY gained for NA/EE was $2200 Canadian dollars ($Can; 1999 values) [compared with no therapy] and was $Can20 300 (compared with CEE/MPA). For second-line therapy, the incremental cost per QALY gained for NA/EE was $Can900 (compared with no therapy) and was $Can16 400 (compared with CEE/MPA). Results were robust to most sensitivity analyses. CONCLUSIONS: NA/EE is a cost-effective therapy for women with menopausal symptoms both as a first-line and second-line therapy.

Cost-Benefit Analysis↗

Quality of life in patients with rheumatoid arthritis : which drugs might make a difference?

Rheumatoid arthritis (RA) is a chronic, disabling, inflammatory polyarthritis that affects patient well-being and QOL. Many disease-modifying antirheumatic drugs (DMARDs) are available for treating RA but patients are often refractory to treatment. The goal of treatment is to improve both general health and health-related QOL. Generic and disease-specific instruments exist to measure QOL. Using these instruments, one can determine if QOL improves with treatment. If the minimal clinically important difference (MCID) for the instrument is known, one can determine if the change is clinically significant. The literature was reviewed in a systematic manner to determine which drugs could affect QOL in patients with refractory RA. Refractory RA is poorly defined but we used the definition of failing at least two DMARDs. Methotrexate, leflunomide, cyclosporin, glucocorticoids, etanercept and infliximab clinically and statistically significantly improved QOL in patients with RA. Gold and epoetin-alpha (erythropoietin) statistically improved QOL in patients with RA but the clinical significance of the improvements could not be determined. These studies were either in non-refractory populations or the refractoriness could not be determined. Further study is required to determine the response of QOL to treatment in patients with refractory RA and instruments with known MCIDs should be used so that the clinical significance of the improvement can be determined.

Anti-Inflammatory Agents, Non-Steroidal↗

OMERACT 6 Economics Working Group report: a proposal for a reference case for economic evaluation in rheumatoid arthritis.

Standardization of methods for economic evaluation is essential for defining the methodological research agenda that will advance the discipline. Standardization also greatly facilitates the interpretation and comparison of the results of economic analyses. For these reasons, several jurisdictions now require economic evaluation, conducted according to standardized methodological guidelines, as a key ingredient in decision making for reimbursement of health treatments and technologies. The application of these general guidelines, however, can be difficult in the absence of disease-specific information. In the case of rheumatoid arthritis (RA), the recent emergence of innovative, highly effective, but also expensive treatments has created an immediate need to more fully understand the economic implications of RA treatments. With this background, the OMERACT Economics Working Group set out in 1994 to develop an RA-specific reference case for economic evaluation. This report summarizes the OMERACT process leading to specific recommendations on the 12 key elements of a proposed "reference case" for economic evaluation in RA. These elements include: study horizon, duration of therapy, extrapolation beyond trial duration, modeling beyond therapy, synthesis of comparisons where head-to-head trials do not exist, clinical outcome measures, mortality, valuation of health states, resource utilization, discontinuation of therapy, therapeutic sequence, and population risk stratification. Through these efforts, the OMERACT Economics Working Group aims to expedite and enhance the conduct and dissemination of methodological research in economic analyses in the rheumatic diseases.

Arthritis, Rheumatoid↗

Economic evaluation of programs or interventions in the management of rheumatoid arthritis: defining a consensus-based reference case.

Improvement in the quality of economic evaluation could be documented as a consequence of international and national standardization efforts. One such effort is the recommendation that all economic evaluations in a given field produce findings in a standard format using a reference case. A reference case-based economic evaluation would adhere to specific settings with regard to outcomes, comparators, modeling techniques, and use of costs to facilitate comparisons among economic evaluations performed with the same objective. In the past, the Outcome Measures in Rheumatology Clinical Trials (OMERACT) consensus conference has successfully developed widely used, consensus-based outcome criteria for clinical improvement in rheumatoid arthritis (RA). Present efforts are being directed at the development of recommendations for the type and format of a reference case economic evaluation for newly developed disease modifying antirheumatic drugs (DMARD). This document discusses 13 important elements that experts considered to be relevant for the development of a reference case recommendation for economic evaluations in RA. We provide the rationale for each element and discuss how each element has been addressed in published economic evaluations of DMARD.

Antirheumatic Agents↗

MCID/Low Disease Activity State Workshop: low disease activity state in rheumatoid arthritis.

The MCID (minimal clinically important difference) module of OMERACT 5 developed a research agenda that led to the conclusion that a state of low disease activity for rheumatoid arthritis (RA) would need to be defined. To develop such a definition the various concepts and terminologies, the process for developing an operational definition, and the availability and design of longitudinal datasets for validation needed to be considered. This article describes the process of the MCID/Low Disease Activity State Workshop at OMERACT 6 to develop such a definition.

Arthritis, Rheumatoid↗

MCID/Low Disease Activity State Workshop: summary, recommendations, and research agenda.

The OMERACT 6 Minimal Clinically Important Difference/Low Disease Activity Workshop was organized with the aim of meeting the many challenges that exist in determining a low disease activity in rheumatoid arthritis (RA). This article presents an overview of that workshop, including results of the voting, a summary of associated discussions, recommendations, and a proposed research agenda.

Arthritis, Rheumatoid↗

Leflunomide for the treatment of rheumatoid arthritis: a systematic review and metaanalysis.

OBJECTIVE: To systematically review the evidence from clinical trials on the efficacy and toxicity of leflunomide for the treatment of active rheumatoid arthritis (RA). METHODS: We searched Medline, Embase, Current Contents, and the Cochrane Controlled Trial Register for human randomized controlled trials (RCT) and controlled clinical trials up to December 2001. We also hand-searched reference lists and conference proceedings and consulted content experts. Relative benefit (RB), and weighted mean differences or standardized mean differences with their 95% confidence interval (95% CI) were calculated. RESULTS: Six RCT totaling 2044 patients with RA were included in this review. Using specific criteria, all trials were considered of high methodological quality. Leflunomide improved the ACR20 response rate roughly 2 times over placebo both at 6 months (RB = 1.93, 95% CI 1.51, 2.47) and at 12 months (RB = 1.99, 95% CI 1.42, 2.77). Other clinical outcomes of disease activity and function and radiological scores were also significantly better for leflunomide patients than those taking placebo. No significant differences for most of the outcomes were observed between leflunomide and sulfasalazine (SSZ) or methotrexate (MTX). Adverse events were more common in the leflunomide group, but withdrawal rates were fewer than for placebo. Overall, withdrawal rates and adverse events in the leflunomide group were not different from SSZ or MTX. CONCLUSION: Leflunomide improves all clinical outcomes and delays radiographic progression at 6 and 12 months of RA treatment compared to placebo. Its efficacy and adverse events at 2 years of treatment are comparable to SSZ and MTX. Longterm efficacy and toxicity remain to be established.

Arthritis, Rheumatoid↗

Cost effectiveness of adding leflunomide to a 5-year strategy of conventional disease-modifying antirheumatic drugs in patients with rheumatoid arthritis.

OBJECTIVE: To estimate, from a public payer's perspective, the 5-year cost effectiveness of adding leflunomide (LEF) to a sequence of disease-modifying antirheumatic drugs (DMARDs) representative of a typical rheumatoid arthritis (RA) management approach adopted by Canadian rheumatologists. METHODS: A DMARD sequence including LEF was compared with one excluding it, using a 5-year simulation model where patients with RA cycle through different treatment regimens. Data were obtained through a systematic literature search (drug withdrawal rates, number and type of adverse events, American College of Rheumatology 20% responder status) and separately conducted surveys (choice of DMARD sequence, management of adverse events). Costs for adverse event management were calculated using the Ontario Schedule of Benefits, and monitoring costs were calculated according to official Canadian product monograph recommendations. Wholesale prices of all drugs were adjusted by the allowable markup and prescription fees. Utilities (as measured by the standard gamble [SG] and rating scale [RS] techniques) were obtained from 482 patients who participated in a 1-year randomized controlled trial that compared LEF, methotrexate, and placebo. Costs and utilities were discounted by 3%. Probabilistic sensitivity analysis was performed. RESULTS: Adding LEF to a conventional strategy of DMARDs increased the 5-year management costs by $1,231 compared with the strategy without LEF, which results in a cost-effectiveness ratio of $13,096 per additional year of response to treatment, and cost-utility ratios of $54,229 (RS) and $71,988 (SG) per quality-adjusted life-year gained. CONCLUSION: Adding LEF as a new option to a conventional sequence of DMARDs extends the time patients may benefit from DMARD therapy at a reasonable cost effectiveness and cost utility. LEF data are limited to clinical trials; data from observational studies would be needed to corroborate these findings.

Anti-Inflammatory Agents, Non-Steroidal↗

Efficacy of the transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a meta-analysis.

BACKGROUND: Low back pain affects a large proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as an alternative therapy to pharmacologic treatments for chronic pain. However, despite its widespread use, the efficacy of TENS is still controversial. PURPOSE: The aim of this meta-analysis was to determine the efficacy of TENS in the treatment of chronic low back pain. METHODS: The authors searched MEDLINE, EMBASE, PEDro, and the Cochrane Controlled Trials Register up to June 1, 2000. Only randomized controlled clinical trials of TENS for the treatment of patients with a clinical diagnosis of chronic low back pain were included. Abstracts were excluded unless further data could be obtained from the authors. Two reviewers independently selected trials and extracted data using predetermined forms. DATA ANALYSIS: Heterogeneity was tested with Cochrane's Q test. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results are presented as weighted mean differences with 95% confidence intervals, where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences were calculated by dividing the difference between the treated and control by the baseline variance. Standardized mean differences were used when different scales were integrated to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. MAIN RESULTS: Five trials were included, with 170 subjects randomized to the placebo group receiving sham TENS and 251 subjects receiving active TENS (153 for conventional mode, 98 for acupuncture-like TENS). The schedule of treatments varied greatly between studies ranging from one treatment/day for 2 consecutive days, to three treatments/day for 4 weeks. There were no statistically significant differences between the active TENS group compared with the placebo TENS group for any outcome measures. Subgroup analysis performed on TENS application and methodologic quality did not demonstrate a significant statistical difference (P > 0.05). Remaining preplanned subgroup analysis was not conducted because of the small number of included trials and the variety of outcome measures reported. CONCLUSION: The results of the meta-analysis present no evidence to support the use or nonuse of TENS alone in the treatment of chronic low back pain. Considering the small number of studies responding to the criteria to be included in this meta-analysis, it is clear that more appropriately designed studies are needed before a final conclusion. Clinicians and researchers should consistently report the characteristics of the TENS device and the application techniques used. New trials on TENS should make use of standardized outcome measures. This meta-analysis lacked data on how TENS efficacy is affected by four important factors: type of applications, site of application, treatment duration of TENS, and optimal frequencies and intensities.

Adult↗

A randomized trial of a computerized versus an audio-booklet decision aid for women considering post-menopausal hormone replacement therapy.

Decision aids (DAs) are increasingly being developed to help patients make shared health care decisions with their practitioners. There are no formal comparisons of the efficacy of different delivery methods. Interactive computerized delivery methods have the advantage of allowing patients control over flow of information and to receive feedback on their comprehension. The purpose of this study was to compare the efficacy of an interactive computerized DA for women considering long-term hormone replacement therapy, to that of a validated audio-booklet version of the same intervention. Fifty-one peri-menopausal women were randomized to use either the computerized or the standard audio-booklet version of the DA. The computerized version presented identical information with the addition of feedback modules to reinforce the participant's understanding. The patients were interviewed with a pre- and post-intervention questionnaire. The computerized DA improved realistic expectations by 52.7% over baseline versus 27.6% with the audio-booklet (P=0.015). Knowledge (Kn) scores improved by 17.5 and 8.4% for the computer and standard DA groups, respectively (P=0.019). The results of this study have implications for future DA design, and other areas where patient Kn and understanding are important, such as in the setting of informed consent.

Aged↗

Development and pilot testing of a decision aid for postmenopausal women with osteoporosis.

This study's aim was to develop and pilot test an evidence-based decision aid for postmenopausal women with osteoporosis who are considering options to prevent fractures. The aid was based on the Ottawa Decision Support Framework, and integrated evidence from our Cochrane systematic reviews. Following development by a panel of experts in osteoporosis and decision making, a user review panel of practitioners and women who had already made their decision about osteoporosis therapy reviewed the decision aid for acceptability. Then the decision aid was pilot tested using a before-after design in women at the point of decision making. Compared to baseline, there were statistically significant improvements in knowledge, realistic expectations and decreased decisional conflict. Our decision aid shows promise in preparing women for counseling about osteoporosis therapies. Long-term adherence to chosen therapy and quality of life will be evaluated in a randomized controlled trial.

Aged↗

Quality of life of individuals with heart failure: a randomized trial of the effectiveness of two models of hospital-to-home transition.

BACKGROUND: The growing number of patients with congestive heart failure has increased both the pressure on hospital resources and the need for community management of the condition. Improving hospital-to-home transition for this population is a logical step in responding to current practice guidelines' recommendations for coordination and education. Positive outcomes have been reported from trials evaluating multiple interventions, enhanced hospital discharge, and follow-up through the addition of a case management role. The question remains if similar gains could be achieved working with usual hospital and community nurses. METHODS: A 12-week, prospective, randomized controlled trial was conducted of the effect of transitional care on health-related quality of life (disease-specific and generic measures), rates of readmission, and emergency room use. The nurse-led intervention focused on the transition from hospital-to-home and supportive care for self-management 2 weeks after hospital discharge. RESULTS: At 6 weeks after hospital discharge, the overall Minnesota Living with Heart Failure Questionnaire (MLHFQ) score was better among the Transitional Care patients (27.2 +/- 19.1 SD) than among the Usual Care patients (37.5 +/- 20.3 SD; P = 0.002). Similar results were found at 12 weeks postdischarge for the overall MLHFQ and at 6- and 12-weeks postdischarge for the MLHFQ's Physical Dimension and Emotional Dimension subscales. Differences in generic quality life, as assessed by the SF-36 Physical component, Mental Component, and General Health subscales, were not significantly different between the Transition and Usual Care groups. At 12 weeks postdischarge, 31% of the Usual Care patients had been readmitted compared with 23% of the Transitional Care patients (P = 0.26), and 46% of the Usual Care group visited the emergency department compared with 29% in the Transitional Care group (chi2 = 4.86, df 1, P = 0.03). CONCLUSIONS: There were significant improvements in health-related quality of life (HRQL) associated with Transitional Care and less use of emergency rooms.

Adult↗