Users' guide to evidence-based surgery: how to use an article evaluating surgical interventions. Evidence-Based Surgery Working Group.
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Bias↗
Biomedical subjects
C H Goldsmith
Publications and source records attributed to C H Goldsmith.
Physical medicine modalities for mechanical neck disorders.
OBJECTIVES: Multiple physical medicine modalities are commonly included as part of therapeutic interventions for mechanical neck disorders (neck pain). The objective of this review was to assess the effects of physical medicine modalities for pain in adults with mechanical neck disorders. SEARCH STRATEGY: We searched Medline, Embase, Chirolars, Index to Chiropractic Literature, Cinahl, Science Citation Index, Conference Proceedings Index, National Technical Information Services and reference lists of the retrieved articles from 1985 to December 1993 and we contacted content experts. SELECTION CRITERIA: Randomised trials and controlled trials of physical medicine modalities in adults with mechanical neck disorder. DATA COLLECTION AND ANALYSIS: Three reviewers independently assessed trial quality and two reviewers independently extracted data. Investigators were contacted to obtain information or data that could not be found in the published reports. MAIN RESULTS: Thirteen trials were included. The overall quality of the included trials was generally good. Two trials using electromagnetic therapy produced a significant reduction in pain (p <0.01) with three to four weeks of daily (eight hours per day) therapy sessions; and three using laser therapy did not differ significantly from a placebo (p=0.20) for six to 10 sessions of treatment. Not enough scientific testing exists to clearly determine the effectiveness of other therapies. This includes treatments such as exercise, traction, acupuncture, heat / cold applications, electrotherapies, cervical orthoses and chronic pain / cognitive behavioural rehabilitation strategies. REVIEWER'S CONCLUSIONS: There is little information available from trials to support the use of physical medicine modalities for mechanical neck pain. There is some support for the use of electromagnetic therapy and against the use of laser therapy with respect to pain reduction.
Adult↗
Patient education for mechanical neck disorders.
BACKGROUND: To track down the best estimate of efficacy of the various conservative management strategies for mechanical neck disorders, a four-part systematic review was prepared. Part four investigates the efficacy of patient education strategies as the therapeutic intervention. OBJECTIVES: This review of patient education is one of four reviews of conservative management of mechanical neck disorders. The other reviews address manual, physical and drug therapies. The objective of this review was to assess the effects of patient education for pain in adults with mechanical neck disorders. SEARCH STRATEGY: We searched Medline, Embase, Chirolars, Index to Chiropractic Literature, Cinahl, Science Citation Index, Conference Proceedings Index, National Technical Information Services from 1985 to December 1993, reference lists of the retrieved articles and we contacted experts in the field. SELECTION CRITERIA: Randomised trials or controlled clinical trials of patient educational strategies for adults with mechanical neck disorders. DATA COLLECTION AND ANALYSIS: Three reviewers independently assessed trial quality and two reviewers independently extracted data. Investigators were contacted to obtain data that could not be found in the published reports. MAIN RESULTS: Three trials were included. Their methodological quality varied from weak to strong. One trial did not find a significant reduction in pain using group instructional strategies (neck school) and exercise with or without psychological counselling compared to no treatment (standardised mean difference 0.07, 95% confidence interval -0.51 to 0.66, and -0.37, 95% confidence interval -0.95 to 0.22, respectively). Another trial did not find a significant reduction in pain using individualised patient education (advice), anti-inflammatories and analgesics compared with placebo (standardised mean difference 0.24, 95% confidence interval -0.58 to 1.07). The third trial found that advice which included demonstrated mobilization exercises, verbal and written instruction on posture correction, the use of a collar, heat sources, muscle relaxation and analgesics gave significant pain relief compared with general advice about mobilisation after a period of rest and use of analgesics at 4 weeks of treatment (standardised mean difference -0.62, 95% confidence interval -1.05 to -0.19) but at 6 weeks of treatment there was no longer any difference (s.m.d. -0.37, 95% confidence interval -0.8 to 0.05). The first two trials lacked statistical power and the third was methodologically weak. REVIEWER'S CONCLUSIONS: Patient education utilising individualised or group instructional strategies has not been shown to be beneficial in reducing pain for mechanical neck disorders.
Adult↗
Predicting subsequent bone density response to intermittent cyclical therapy with etidronate from initial density response in patients with osteoporosis.
We investigated whether an increase in lumbar spine bone mineral density (LS BMD) at 6 months or at 12 months could predict the response to intermittent cyclical therapy (ICT) with etidronate, defined in one of two ways: (i) an increase in LS BMD at 24 months (improvement) or (ii) an increase in LS BMD > or = 0.028 g/cm2 (significant improvement). The latter is a precision term calculated from test-retest values for LS BMD in osteoporotic patients. Two hundred and forty-seven patients (32 men; 5 premenopausal and 210 postmenopausal women) were followed for 24 months by dual-energy X-ray absorptiometry (DXA) and were not taking estrogen, calcitonin or fluoride during treatment with ICT-etidronate. One hundred and fifty patients had a LS BMD measurement after 6 months of treatment with ICT-etidronate and 205 patients had one at 12 months. Baseline characteristics (mean;SD) were as follows: age, 66;11 years; years since menopause, 21;10; number of vertebral fractures at baseline, 0.87;1.26; LS BMD T-score, -2.8; 1.2. After 24 months of treatment with ICT-etidronate, 81% of the patients had an improvement, and 55% had a significant improvement at the LS. Only 6% significantly lost bone (loss of 0.028 g/cm2 or more). The mean percent change from baseline in LS BMD was 5.1% (95% confidence interval 4.2% to 6.0%). The results for men and postmenopausal women were similar to those for the entire group. Accuracy and sensitivity were marginally, but not significantly, higher when response was predicted using 12 month versus 6 month LS BMD measurements. The positive predictive values of improvement at 6 or 12 months were 89% and 90% respectively for improvement at 24 months, and 66% and 68% for significant improvement at 24 months. Identification of nonresponders was less successful and similar at 6 months and 12 months. Forty percent and 39% of the patients, who had no improvement at 6 or 12 months respectively, also had no improvement at 24 months, i.e., were true negatives, while 77% and 71% had no significant improvement at 24 months. The results may reflect slow response in a small subgroup of patients rather than nonresponse; however, no response at 1 year might identify patients whose rate of response is sufficiently slow that alternative therapy is justified. These data demonstrate a good response rate to ICT-etidronate and may help reduce the need for follow-up BMD measurements in those who show an early improvement.
Absorptiometry, Photon↗
The Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index for Systemic Lupus Erythematosus International Comparison.
OBJECTIVE: To compare patients with systemic lupus erythematosus (SLE) from different centers with respect to demographics and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI) scores, and to assess whether the SLICC/ACR DI changed over time, and whether initial DI scores were related to outcome. METHODS: Members of SLICC completed DI scores and patient demographics on patients followed in their centers. Information was provided at 2, 5-10, and > 10 years of followup. Data were entered on computer and analyzed on SPSS/PC+ and SAS using descriptive statistics and analysis of variance. RESULTS: Information for 1297 patients within 2 years of first clinic visit was submitted from 8 centers. There were 1187 women and 110 men with a mean age at diagnosis of SLE of 32 years. Seven hundred sixty-two were Caucasian, 423 were black, and the remainder were of other races. There were more blacks in the American centers than in Canadian or European centers. Five centers provided information for the 3 time periods. The DI increased over time. Ninety-nine patients had died. Higher SLICC/ACR DI scores were documented in patients who went on to die. CONCLUSION: The SLICC/ACR DI is a valid measure for damage in SLE.
American Medical Association↗
Fibromyalgia: can one distinguish it from simulation? An observer-blind controlled study.
OBJECTIVE: A randomized controlled trial was conducted to assess reliability and accuracy in identification of fibromyalgia (FM), motivated simulation, and normal controls. METHODS: Eight female subjects with chronic FM were age matched with 19 healthy female volunteers. The volunteers were randomized to a financially motivated "simulator" group who were paid to simulate FM, or to a "normal control" group. Examiners under blinded conditions rated tender and control points, and illness behavior. Intraclass correlation coefficients and F values showed that counts of tender points significantly discriminated the 3 groups. Variance was mostly due to experimental groups and not to observer or error factors. In this study, simulators could not be discriminated from normals or FM subjects on the basis of tenderness at "control points." Examiner ratings of illness behavior (UAB), and subjects' self-ratings for pain showed that FM subjects had the highest scores, normals the lowest, and simulators had mean scores midway between the mean FM and simulator. On grip strength, the normals obtained the highest scores, the simulators the lowest, and the FM subjects had scores midway between those of the other 2 groups. Diagnostic accuracy of the blinded examiners in distinguishing FM from simulators and from normals was 80%, and for correct diagnosis the kappa value was significant at 0.69. Despite this, simulators were misidentified as FM in 1/3 of judgments, and FM was misidentified as simulators in 1/5 of judgments. CONCLUSION: Under randomized blinded conditions, examiners using the American College of Rheumatology criteria for FM and other bedside observations are able to distinguish chronic FM, normal individuals, and motivated simulators with 80% accuracy, with a good level of agreement and reliability in tender point counts. Our results do not provide a "test for malingering," and it is likely that an important minority of motivated simulators and of FM subjects will be misidentified.
Adult↗
36 month intermittent cyclical etidronate treatment in patients with established corticosteroid induced osteoporosis.
OBJECTIVE: To determine the longterm safety and efficacy of etidronate therapy in patients in whom corticosteroid induced bone loss has already occurred. METHODS: We performed a 36 month observational cohort study in which all data were obtained from Canadian Database of Osteoporosis and Osteopenia (CANDOO) patients. The etidronate group consisted of 24 patients who received 400 mg of etidronate disodium for 14 days, followed by 76 days of calcium carbonate (500 mg of elemental calcium), repeated every 3 mo; the control group included 37 patients who received calcium carbonate 500 to 1000 mg daily. Outcome measurements included changes within groups from baseline and differences between groups in the bone mineral density (BMD) of the lumbar spine, femoral neck, and trochanter at 12, 24, and 36 months. The incidence of vertebral fractures was also determined. RESULTS: Etidronate therapy resulted in a meaningful percentage increase from baseline in lumbar spine BMD, primarily during the first 24 months of treatment, and this increase was sustained for the remainder of the 36 month study period (5.2%; p = 0.016). Analysis of covariance revealed a significant percentage difference (SD) between groups in lumbar spine BMD at 12 [5.5 (13.5) percent; p = 0.003] and 24 months [6.0 (17.4) percent; p = 0.011] in favor of the etidronate group. After 3 years of therapy, one patient (4%) experienced one vertebral fracture in the etidronate group, whereas 3 patients (8%) experienced 5 vertebral fractures in the control group. CONCLUSION: Etidronate treatment administered for 36 months reversed lumbar spine bone loss, and appeared to be safe in patients with established corticosteroid induced osteoporosis.
Adrenal Cortex Hormones↗
Does strengthening the abdominal muscles prevent low back pain--a randomized controlled trial.
OBJECTIVE: To investigate the effects of abdominal muscle strengthening exercise on low back pain (LBP) risk reduction. METHODS: We compared the effects of abdominal muscle strength (AMS) exercise and back education with back education only on 402 asymptomatic subjects with weak AMS. The primary outcome was the percentage of subjects with at least one episode of LBP at 24 months. A diary was used to monitor compliance. RESULTS: There were no statistically significant differences between experimental (E) and control (C) subjects at 24 months for LBP episodes (E: 34.7%, C: 30.4%; C-E = 4.2%, P2 = 0.481; 95% CI -16.1%, 7.6%). The LBP episodes were also not statistically significantly different at 6 months (E: 13.2%, C: 16.1%; C-E: 2.9%, P2 = 0.493; 95% CI -5.3%, 11.0%) or at 12 months (E: 24.8%, C: 23.6%; C-E = -1.2%, P2 = 0.818; 95% CI -11.6%, 9.2%). Adjusting the data for strata and baseline AMS did not alter the findings. Imputed results for LBP episodes at 6 months (C-E: 4.8%, P2 = 0.191; 95% CI -2.4%, 12.0%), 12 months (C-E: -1.0%, P2 = 0.821; 95% CI -9.5%, 7.6%), and 24 months (C-E: -3.3%, P2 = 0.483; 95% CI -12.6%, 5.9%) were also not statistically significantly different. CONCLUSION: Back education and abdominal exercise instructions are similar to back education alone. There were no group differences in LBP episodes, possibly due to noncompliance with the exercise program. While the estimated benefit of 2.9% at 6 months from the complete data and 4.8% from the imputed data were not statistically significant, a larger study or future metaanalyses may be needed to confirm whether there is a clinical benefit or whether these results should be considered a chance finding.
Abdominal Muscles↗
Therapeutic equivalence: all studies are not created equal.
With an increasing number of available treatment options, clinicians must frequently evaluate whether comparable therapies are equivalent in terms of efficacy and safety. Two methodologically distinct study designs are used to establish therapeutic equivalence: standard superiority trials and true equivalence trials. In either study design, clinician-readers assess equivalence by examining both the statistical significance and the clinical importance of the study results (as defined by the minimally important difference, the smallest difference in patient outcome that would lead to an important difference in patient health status). Once therapeutic equivalence has been established, clinicians may select one therapy as the preferred treatment option because it offers other clinical benefits, such as a lower cost or a more convenient drug administration schedule.
Female↗
Does smoking cause rheumatoid arthritis?
Explore the source record for details and available documents.
Arthritis, Rheumatoid↗
A comparison of active and simulated chiropractic manipulation as adjunctive treatment for childhood asthma.
BACKGROUND: Chiropractic spinal manipulation has been reported to be of benefit in nonmusculoskeletal conditions, including asthma. METHODS: We conducted a randomized, controlled trial of chiropractic spinal manipulation for children with mild or moderate asthma. After a three-week base-line evaluation period, 91 children who had continuing symptoms of asthma despite usual medical therapy were randomly assigned to receive either active or simulated chiropractic manipulation for four months. None had previously received chiropractic care. Each subject was treated by 1 of 11 participating chiropractors, selected by the family according to location. The primary outcome measure was the change from base line in the peak expiratory flow, measured in the morning, before the use of a bronchodilator, at two and four months. Except for the treating chiropractor and one investigator (who was not involved in assessing outcomes), all participants remained fully blinded to treatment assignment throughout the study. RESULTS: Eighty children (38 in the active-treatment group and 42 in the simulated-treatment group) had outcome data that could be evaluated. There were small increases (7 to 12 liters per minute) in peak expiratory flow in the morning and the evening in both treatment groups, with no significant differences between the groups in the degree of change from base line (morning peak expiratory flow, P=0.49 at two months and P=0.82 at four months). Symptoms of asthma and use of 3-agonists decreased and the quality of life increased in both groups, with no significant differences between the groups. There were no significant changes in spirometric measurements or airway responsiveness. CONCLUSIONS: In children with mild or moderate asthma, the addition of chiropractic spinal manipulation to usual medical care provided no benefit.
Adolescent↗
Community Intervention Trial for Smoking Cessation (COMMIT): changes in community attitudes toward cigarette smoking.
The success of the Community Intervention Trial for Smoking Cessation (COMMIT) in changing smoking attitudes is examined by testing two primary hypotheses: (1) the priority of smoking as a public health problem increased more in the intervention communities than in the comparison communities, and (2) norms and values that support non-smoking increased more in the intervention than in the comparison communities. One community within each of 11 matched pairs was randomly assigned to receive a 4-year (1989-92) community-based smoking control intervention. Community attitudes towards smoking were measured primarily by cross-sectional surveys in 1989 (n = 9875) and 1993 (n = 14117) but a cohort (n = 5450) also provided attitude information. The main trial effect was on heavy smokers in the intervention communities who showed significantly more change in their beliefs about smoking as a public health problem. Despite the absence of an intervention-comparison difference, the magnitude of change in community-wide norms and values was related to the level of smoking control activities. In the cohort, light-to-moderate smokers in the intervention communities came to have stronger beliefs about smoking as a serious public health problem. COMMIT's impact on the beliefs of heavy smokers about the seriousness of smoking as a public health problem has important public health implications.
Adult↗
Measuring attitudes towards smoking in the Community Intervention Trial for Smoking Cessation (COMMIT).
We present the development of indices using baseline data from the Evaluation Survey for the Community Intervention Trial for Smoking Cessation (COMMIT). The indices are designed to measure two primary attitude constructs that relate to smoking behavior: beliefs about smoking as a public health problem (SPHP); and norms and values concerning smoking (NVS). Two general approaches to index construction, the rational method and the factor analytic method, were used. Item analysis suggested good internal consistency for both indices (alpha > 0.75). Seven subconstructs emerged from the factor analysis accounting for 55.0% of the total variance. The SPHP and NVS items uniquely identify with four factors and three factors, respectively, confirming the validity of the two indices. Confirmatory factor analyses of a different data set provided further validation. Validity was also assessed by an examination of the relationships between index scores and smoking status. Smokers reported significantly higher scores than non-smokers on the two measures indicating, as anticipated, that smokers have more favorable attitudes towards smoking than non-smokers. These findings suggest that the two a priori constructs of SPHP and NVS are empirically distinguishable components of attitudes towards smoking, and that the indices developed here are reliable and valid measures of those constructs.
Adult↗
A randomized controlled trial to evaluate the efficacy of community based physical therapy in the treatment of people with rheumatoid arthritis.
OBJECTIVE: To evaluate the short term efficacy of a community based physical therapy (PT) program for people with rheumatoid arthritis (RA) through a single blind randomized controlled trial. METHODS: Adults with active RA were referred by their physician for community based PT. Participants were randomized to either an immediate intervention group [experimental group (EG)] or a wait list control group (CG). The intervention was a standardized program of education and exercise consisting of at least 4 visits or 3 h of PT over 6 weeks. Baseline, 6, and 12 week assessments were by a blinded independent assessor. The primary outcome instrument was the Stanford Arthritis Self-Efficacy Scale (SES) and secondary outcome measures included the ACREU Rheumatoid Arthritis Knowledge Questionnaire (KQ) and visual analog scale for pain (VAS). Duration of morning stiffness, grip strength, and tender joint count were also collected at each assessment. Outcome analysis was conducted using analysis of variance. RESULTS: Of 150 eligible and randomized participants, 127 completed the study according to protocol. Baseline analysis showed no differences between the EG and CG for demographics, disease status, or other characteristics. At the 6 week assessment, primary outcome analysis for those who completed the protocol identified a mean change (improvement) of 13.5% in the EG and 5.8% in the CG, representing a 7.7% difference in change scores between the 2 groups [F(1,121) = 6.03; p = 0.015]. A statistically significant difference in change scores was also identified for the KQ [F(1,120) = 6.67; p = 0.011], but not for the VAS. Disease status measures did not change, except for duration of morning stiffness, which improved by 68.8 min in the EG and 8.3 min in the CG (F(1,121) = 4.50; p = 0.036]. CONCLUSION: Four hours of a community based PT intervention delivered over 6 weeks significantly improved self-efficacy, disease management knowledge and morning stiffness in people with RA.
Adult↗
The reliability of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index in patients with systemic lupus erythematosus.
OBJECTIVE: To test the reliability of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) in the assessment of patients with SLE. METHODS: Ten patients with SLE, representing a spectrum of damage and activity, were included. Each patient was examined by 6 of 10 physicians from 5 countries, representing 10 lupus clinics. The SLICC/ACR Damage Index was used to assess accumulated damage, and the SLEDAI was used to assess disease activity. The order of the patients and physicians was randomized according to a Youden square design. RESULTS: The SLICC/ACR Damage Index detected differences among patients (P < 0.001). There was no detectable observer difference (P = 0.933), and there was no order effect (P = 0.261). Similar results were obtained with the SLEDAI. There was concordance in the SLICC/ACR Damage Index among observers, despite a wide spectrum of disease activity detected by the SLEDAI. CONCLUSION: Physicians from different centers are able to assess patients with SLE in a reproducible way, using the SLEDAI to assess disease activity and the SLICC/ACR Damage Index to assess accumulated damage.
Adult↗
Use of the standard error as a reliability index of interest: an applied example using elbow flexor strength data.
The intraclass correlation coefficient (ICC) and the standard error of measurement (SEM) are two reliability coefficients that are reported frequently. Both measures are related; however, they define distinctly different properties. The magnitude of the ICC defines a measure's ability to discriminate among subjects, and the SEM quantifies error in the same units as the original measurement. Most of the statistical methodology addressing reliability presented in the physical therapy literature (eg, point and interval estimations, sample size calculations) focuses on the ICC. Using actual elbow flexor make and break strength measurements, this article illustrates a method for estimating a confidence interval for the SEM, shows how an a priori specification of confidence interval width can be used to estimate sample size, and provides several approaches for comparing error variances (and square root of the error variance, or the SEM).
Analysis of Variance↗
A double-blind randomised controlled trial of the effects of medroxyprogesterone acetate on bone density of women taking oestrogen replacement therapy.
OBJECTIVE: To assess the effects of medroxyprogesterone acetate on bone density in women who have had a hysterectomy. DESIGN: Randomised, double-blind, placebo-controlled trial of medroxyprogesterone acetate 10 mg, 20 mg or placebo as an adjunct to oestrogen therapy. PARTICIPANTS: One hundred and twenty-three women, aged 18 to 45 years and currently receiving daily oestrogen, who presented at a university-based rheumatology practice. INTERVENTIONS: The women were randomly assigned to receive either medroxyprogesterone acetate 10 mg, 20 mg or placebo daily beginning on day 15 of each month for one year. Forty-one women were randomised into each group. MAIN OUTCOME MEASURE: The primary outcome measurement was the percentage of change from baseline in bone mineral density of the lumbar spine (L2-L4). Secondary outcome measures included differences in femoral neck bone density, cholesterol and triglyceride levels between groups. RESULTS: At one year, change in bone mineral density did not differ between either the treatment or placebo groups. Medroxyprogesterone acetate 20 mg and 10 mg led to statistically significant reductions in very low density lipoprotein cholesterol, total triglycerides, and very low density lipoprotein triglycerides when compared with placebo. Medroxyprogesterone acetate 20 mg also led to a statistically significant reduction in high density lipoprotein cholesterol, high density lipoprotein-2 cholesterol, and high density lipoprotein-2 triglycerides. CONCLUSIONS: Medroxyprogesterone acetate at either dose as an adjunct to oestrogen did not improve bone mineral density at one year when compared with placebo. Medroxyprogesterone acetate 10 mg may not adversely affect lipids. Medroxyprogesterone acetate 20 mg, however, did reduce high density lipoprotein cholesterol and therefore may increase cardiovascular risk.
Adolescent↗
Evaluation of an educational program to prevent adolescent pregnancy.
The authors evaluated the effectiveness of a school-based sex education program in decreasing rates of sexual intercourse, improving birth control use, and decreasing the incidence of pregnancies among teenagers 16 years of age and younger. Twenty-one schools received either the McMaster Teen Program or the conventional didactic sex education program. Preprogram, the mean age of the students was 12.6 years. There were no statistically significant differences between groups in time to first sexual activity for males, chi 2(1) = 2.93, p = 0.09; time to first sexual activity for females, chi 2(1) = 0.50, p = 0.48; and time to first pregnancy, chi 2(1) = 1.90, p = 0.17. Significantly more experimental group males reported always using birth control at year 1 (difference 8.9%; 95% confidence interval [CI] = 0.4, 17.4). Limitations of the program that may have influenced the results were the exclusion of contraception information and its short duration.
Adolescent↗