Vivian Robinson

Realist review to understand the efficacy of school feeding programmes

A recent Cochrane review found that school feeding programmes significantly improve the growth and cognitive performance of disadvantaged children. Trisha Greenhalgh,Elizabeth Kristjansson, and Vivian Robinson look more closely at the highly heterogeneous trials to see what works, for whom, and in what circumstances

Applying clinical epidemiological methods to health equity: the equity effectiveness loop

Focusing on the average effects of interventions on health may miss important differences within populations. Examining these effects across gradients in wealth allows the identification of the interventions most likely to reduce health inequalities

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 onTENS 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.

Ottawa Panel Evidence-Based Clinical Practice Guidelines for Aerobic Fitness Exercises in the Management of Fibromyalgia: Part 1

Background and Purpose: The objective of this study was to create guidelines for the use of aerobic fitness exercises in the management of adult patients (>18 years of age) with fibromyalgia, as defined by the 1990 American College of Rheumatology criteria. Methods: Following Cochrane Collaboration methods, the Ottawa Methods Group found and synthesized evidence from comparative controlled trials and formed the Ottawa Panel, with nominated experts from key stakeholder organizations. The Ottawa Panel then developed criteria for grading the recommendations based on experimental design (I for randomized controlled trials, II for nonrandomized studies) and strength of evidence (A, B, C+, C, D+, D, or D−). From the rigorous literature search, 13 randomized control trials and 3 controlled clinical trials were selected. Statistical analysis was based on Cochrane Collaboration methods. Continuous data were calculated with weighted mean differences between the intervention and control groups, and dichotomous data were analyzed with relative risks. Clinical improvement was calculated using absolute benefit and relative difference in change from baseline. Clinical significance was attained when an improvement of 15% relative to a control was found. Results: There were 24 positive recommendations: 10 grade A, 1 grade B, and 13 grade C+. Of these 24 positive recommendations, only 5 were of clinical benefit. Discussion and Conclusion: The Ottawa Panel recommends aerobic fitness exercises for the management of fibromyalgia as a result of the emerging evidence (grades A, B, and C+, although most trials were rated low quality) shown in the literature.

EFFICACY OF STRENGTHENING EXERCISES FOR OSTEOARTHRITIS (PART I): A META-ANALYSIS

Abstract Objective: Osteoarthritis (OA) is highly prevalent among older adults and is associated with increased pain, loss of strength and joint range of motion (ROM), as well as to an overall decrease in functional status. Therapeutic strength exercises are recommended as part of the standard intervention programme for the patient with OA in an effort to control pain and improve functional and health status. The purpose of this meta-analysis is to review the strength and quality of evidence supporting the effectiveness of therapeutic strengthening exercises for improving a variety of measured outcomes relevant for OA. Methods: A systematic review was conducted, following a protocol of methods recommended by the Cochrane Collaboration. Trials were identified by a literature search of Medline, EMBASE, and the Cochrane Controlled Trials Register. Only randomised controlled trials using strengthening exercises as an intervention and treating clients with OA were eligible. Twenty-two trials were included with 2325 patients undergoing various forms strengthening exercises (e.g. isometric, isotonic, isokinetic, concentric, concentric/eccentric, dynamic). The exercises were implemented either in stand-alone format or in combination with other exercises, such as stretching and ROM. Interventions were either facility-based, home-based or a combination of the two. Results: Evidence is provided for the inclusion of strengthening exercises in the rehabilitation programme for the patient with OA. Improvements were found for strength, pain, function and quality of life (QOL). Important components of the exercise programme that influence outcome include: (i) the combination of joint-specific strengthening with general strength, flexibility and functional exercises; (ii) progression of the exercise programme; and (iii) level of client self-reliance to sustain the programme. There is no evidence that the type of strengthening (i.e. isometric, isotonic or isokinetic) has an important impact on programme outcome. However, evidence is provided that the control of pain may be a dominant mechanism by which strengthening exercise produces beneficial effects for the patient with OA. Conclusion: Strengthening exercises alone have some effects on improving pain and functional outcomes in clients with OA. However, in order to maximise the effectiveness of strengthening exercise for these clients, it is necessary to combine strengthening exercises with a more complete exercise programme including ROM, stretching, functional balance and aerobic exercises.

Ottawa Panel Evidence-Based Clinical Practice Guidelines for Strengthening Exercises in the Management of Fibromyalgia: Part 2

Background and Purpose: The objective of this study was to create guidelines for the use of strengthening exercises in the management of adult patients (>18 years of age) with fibromyalgia (FM), as defined by the 1990 American College of Rheumatology criteria. Methods: Following Cochrane Collaboration methods, the Ottawa Methods Group found and synthesized evidence from comparative controlled trials and formed the Ottawa Panel, with nominated experts from key stakeholder organizations. The Ottawa Panel then developed criteria for grading the recommendations based on experimental design (I for randomized controlled trials, II for nonrandomized studies) and strength of evidence (A, B, C+, C, D+, D, or D−). From the rigorous literature search, 5 randomized controlled trials were selected. Statistical analysis was based on Cochrane Collaboration methods. Continuous data were calculated with weighted mean differences between the intervention and control groups, and dichotomous data were analyzed with relative risks. Clinical improvement was calculated using absolute benefit and relative difference in change from baseline. Clinical significance was attained when an improvement of 15% relative to a control was found. Results: There were 5 positive recommendations: 2 grade A and 3 grade C+. All 5 were of clinical benefit. Discussion and Conclusion: The Ottawa Panel recommends strengthening exercises for the management of fibromyalgia as a result of the emerging evidence (grades A, B, and C+, although most trials were rated low quality) shown in the literature.

Transcutaneous Electrical Nerve Stimulation for the Treatment of Chronic Low Back Pain : A Systematic Review

Study Design. Systematic review. Objective. To determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) in the management of chronic LBP. Summary of Background Data. Chronic low back pain (LBP) affects a significant proportion of the population. TENS was introduced more than 30 years ago as an adjunct to pharmacologic pain management. However, despite its widespread use, the usefulness of TENS in chronic LBP is still controversial. Methods. We searched MEDLINE, EMBASE, PEDro, and the Cochrane Central Register of Controlled Trials (Issue 2, 2005), up to April 1, 2005. Only randomized controlled clinical trials (RCTs) evaluating the effect of TENS on chronic LBP were included. Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochrane’s Q test. A fixed effect model was used throughout for calculating 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 (95% CI), 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 used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. Results. Two RCTs (175 patients) were included. They differed with respect to study design, methodologic quality, inclusion and exclusion criteria, characteristics of TENS application, treatment schedule, cointerventions, and measured outcomes. In one RCT, TENS produced significantly greater pain relief than the placebo control. However, in the other RCT, no statistically significantdifferences between treatment and control groups were shown for multiple outcome measures. Preplanned subgroup analyses, intended to examine the impact of different stimulation parameters, sites of TENS application, treatment durations, and baseline patient characteristics were not possible because of the small number of included trials. Conclusions. Evidence for the efficacy of TENS as an isolated intervention in the management of chronic LBP is limited and inconsistent. Larger, multicenter, RCTs are needed to better resolve its role in this condition. Increased attention should be given to the risks and benefits of long-term use, which more appropriately addresses the realities of managing chronic low back pain.

Number needed to treat (NNT): implication in rheumatology clinical practice

Objective: To calculate the number needed to treat (NNT) and number needed to harm (NNH) from the data in rheumatology clinical trials and systematic reviews. Methods: The NNTs for the clinically important outcome measures in the rheumatology systematic reviews from the Cochrane Library, issue 2, 2000 and in the original randomised, double blind, controlled trials were calculated. The measure used for calculating the NNT in rheumatoid arthritis (RA) interventions was the American College of Rheumatology 20% improvement or Paulus criteria; in osteoarthritis (OA) interventions, the improvement of pain; and in systemic sclerosis (SSc) interventions, the improvement of Raynauds phenomenon. The NNH was calculated from the rate of withdrawals due to adverse events from the treatment. Results: The data required for the calculation of the NNT were available in 15 systematic reviews and 11 original articles. For RA interventions, etanercept treatment for six months had the smallest NNT (1.6; 95% confidence interval (CI) 1.4 to 2.0), whereas leflunomide had the largest NNH (9.6; 95% CI 6.8 to 16.7). For OA treatment options, only etodolac and tenoxicam produced significant pain relief compared with placebo (NNT=4.4; 95% CI 2.4 to 24.4 and 3.8; 95% CI 2.5 to 7.3, respectively). For SSc interventions, none were shown to be efficacious in improving Raynauds phenomenon because the 95% CI of the NNT was infinite. Conclusions: The NNT and NNH are helpful for clinicians, enabling them to translate the results from clinical trials and systematic reviews to use in routine clinical practice. Both NNT and NNH should be accompanied by a limited 95% CI and adjusted for the individual subjects baseline risk.

Consumer-driven health care: Building partnerships in research

Over the past four decades, there has been a widespread movement to increase the involvement of patients and the public in health care. Strategies to effectively foster consumer participation are occurring within all research activities from research priority setting to utilization. One of the ten principles of the Cochrane Collaboration is to ‘enable wide participation’, and this includes consumers. The Cochrane Musculoskeletal Group (CMSG) is a review group of 50 within the Collaboration that has been working to increase consumer participation since its inception in 1993. Based in Canada, the CMSG has embraced the concept of knowledge translation as advocated by the Canadian Institutes of Health Research. The emphasis in knowledge translation is on interactions or partnerships between researchers and users to facilitate the use of relevant research in decision making. While the CMSG recognizes the importance of reaching all users, much of its work has focused on developing relationships with people with musculoskeletal diseases to enhance consumer participation in research. The CMSG has built a network of consumer members who guide research priorities, peer review systematic reviews and also promote and facilitate consumer‐appropriate knowledge dissemination. Consumers were recruited through links with other arthritis organizations and the recruitment continues. Specific roles were established for the consumer team and responsibilities of the CMSG staff developed. The continuing development of a diversified team of consumer participants enables the CMSG to produce and promote access to high quality relevant systematic reviews and summaries of those reviews to the consumer.

EFFICACY OF BALNEOTHERAPY FOR OSTEOARTHRITIS OF THE KNEE: A SYSTEMATIC REVIEW

Abstract Balneotherapys role in treating patients with arthritic disease is much debated. More common in treating patients with rheumatoid arthritis, balneotherapys efficacy for patients with osteoarthritis needs further exploration. Our systematic review included three randomized controlled trials examining the effects of various types of balneotherapy on osteoarthritis of the knee. Thermal water balneotherapy showed clinical benefit but no statistical significance for pain relief. Combination hot sulphur and Dead Sea baths were more statistically significant and clinically effective than single bath treatments for short-term measures of pain and function. A combination bath regime also had a significant effect on pain severity at onemonth follow-up. No significant long-term (three months) benefits were observed for pain or function. We conclude that balneotherapy in the form of combination baths has short-term benefits for pain relief and function, which suggests that balneotherapy may require a standard treatment regime for optimal efficacy.