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Biomedical subjects

C H Goldsmith

Publications and source records attributed to C H Goldsmith.

At least 19 recordsLinked to original sources
PubMed1999

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↗
PubMed1999

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↗
PubMed1999

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↗
PubMed1998

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↗
PubMed1998

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↗
PubMed1998

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↗
PubMed1998

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↗
PubMed1997

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↗
PubMed1997

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↗
PubMed1997

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↗
PubMed1997

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↗
PubMed1997

Community screening for rheumatic disorder: cross cultural adaptation and screening characteristics of the COPCORD Core Questionnaire in Brazil, Chile, and Mexico. The PANLAR-COPCORD Working Group. Pan American League of Associations for Rheumatology. Community Oriented Programme for the Control of Rheumatic Disease.

OBJECTIVE: (1) To adapt the Community Oriented Programme for the Control of Rheumatic Disease (COPCORD) Core Questionnaire (CCQ) for use as a rheumatic disease screening instrument in Spanish and Portuguese communities in Brazil, Chile, and Mexico, including translation and back translation, and assessment of cross cultural equivalence and reliability. (2) To determine the screening characteristics of the CCQ, specifically the sensitivity and specificity of Spanish and Portuguese versions for detecting cases of rheumatic disorder compared with a full clinical examination by a rheumatologist. (3) To determine the number of clinical examinations that could be avoided in population studies by applying the CCQ followed by a clinical examination in positive CCQ screenees. METHODS: Translation and assessment of cross cultural equivalence were conducted by practising rheumatologists in Brazil, Chile, and Mexico using standardized methods. Back translation was done by an independent rheumatologist (Brazil), a radiologist (Chile), and a general physician (Mexico). Interviewer agreement was assessed in all sites in a convenience sample. Sensitivity and specificity were assessed by independently administering the CCQ and a full clinical examination to a sample of 200 persons aged 15 years or older, randomly selected from communities in Sao Paulo, Brazil (n = 200), Temuco, Chile (n = 200), and Mexico City, Mexico (n = 200). RESULTS: (1) Cross cultural equivalence and back translation of the modified questionnaire were satisfactory. Interviewer agreement was acceptable. (2) In groups from Brazil, Chile, and Mexico, respectively, the overall prevalence of rheumatic disease based on clinical examination was 33.3, 45.1, and 46.3%. The sensitivity and specificity of 2 definitions of a positive CCQ screening for the presence of rheumatic disorder were: Definition 1 (no trauma, present pain, tenderness, swelling or stiffness in bones, joints or muscles): sensitivity, 91.8, 96.0, 84.0; specificity, 70.0, 35.5, 61.0; Definition 2 (Definition 1 plus pain intensity > or = 4 and 11 point category rating scale): sensitivity, 66.2, 86.3, 42.7; specificity, 82.3, 41.9, 80.0. (3) In groups from Brazil, Chile, and Mexico, respectively, positive screening by Definition 1 followed by a clinical examination avoids 499, 213, and 403 clinical examination per 1000 respondents screened and yields an overall prevalence of rheumatic disorder of 30, 43, and 40%. The addition of pain intensity (Definition 2) increased the total number of examinations avoided, but reduced the prevalence estimate compared to Definition 1 (22.0, 39.0, and 20.0%). CONCLUSION: The CCQ appears promising as a screening tool to detect rheumatic disorder in Spanish and Portuguese speaking communities in a developing country. The findings suggest that the CCQ followed by a full clinical examination in positive respondents can provide an acceptable estimate of prevalence of rheumatic disorder. The total number of clinical examinations that must be administered in population based prevalence surveys can be reduced by using the CCQ, while maintaining satisfactory accuracy. Our findings need to be confirmed in further applications of the CCQ.

Adolescent↗
PubMed1997

Health state utilities in knee replacement surgery: the development and evaluation of McKnee.

OBJECTIVE: 1. To develop McKnee, a classification system and direct utility measure for health states associated with knee replacement (KR) surgery. 2. To apply McKnee in a before-after study of KR surgery to: (i) gain experience with McKnee in an elderly population; (ii) confirm the practicality and usefulness of the McKnee system; (iii) assess self-health utility one week before and 3 mo after surgery; (iv) evaluate the stability of 3 clinical marker health states describing mild, moderate, and severe knee disability; (v) compare self-health utility scores with Short Form 36 (SF-36). METHODS: 1. Instrument development: The McKnee modified Health Utilities Index was developed and used to describe self-health and clinical marker health states: the clinical validity of the clinical marker states was evaluated by 5 clinicians involved in the care off KR patients. 2. Instrument evaluation: McKnee and the SF-36 were administered to 48 patients with osteoarthritis one week before and 3 mo after KR surgery. RESULTS: Before-after study: McKnee was feasible and acceptable in the older patient group studied (mean age in years, SD: 69.9, 8.6). No change in self-health utility (mean, SD) was observed at 3 mo postsurgery: before -0.78, 0.17; after -0.78, 0.21. On the SF-36, only the change scores for pain and health transition were statistically significant. Utilities (mean, SD) for the clinical marker health states were: mild -0.80, 0.20; moderate -0.55, 0.28; and severe -0.48, 0.31. The clinical marker mean utility scores were stable between the baseline and 3 mo assessment, but the intraclass correlation coefficients for individual scores were low. CONCLUSION: McKnee provides a preference based measure of health related quality of life that can be used to obtain and interpret clinically the knee disability utility scorers needed for cost-utility studies and medical decision-making models about KR surgery. The McKnee system provides a practical and useful method for classifying knee disability health states and obtaining direct measurements of utility scores for selected health states.

Aged↗
PubMed1996

Conservative management of mechanical neck pain: systematic overview and meta-analysis.

OBJECTIVE: To review the efficacy of conservative management of mechanical neck disorders. METHODS: Published and unpublished reports were identified through computerised and manual searches of bibliographical databases, reference lists from primary articles, and letters to authors, agencies, foundations, and content experts. Selection criteria were applied to blinded articles, and selected articles were scored for methodological quality. Effect sizes were calculated from raw pain scores and combined by using meta-analytic techniques when appropriate. RESULTS: Twenty four randomised clinical trials met the selection criteria and were categorised by type of intervention: nine used manual treatments; 12 physical medicine methods; four drug treatment; and three education of patients (four trials investigated more than one form of intervention). The intervention strategies were summarised separately. Pooling of studies was considered only within each category. Five of the nine trials that used manual treatment in combination with other treatments were combined. One to four weeks after treatment the pooled effect size was -0.6 (95% confidence interval -0.9 to -0.4), equivalent to an improvement of 16 (6.9 to 23.1) points on a 100 point scale. Sensitivity analyses on study quality, chronicity, and data imputation did not alter this estimate. For other interventions, studies could not be combined to arrive at pooled estimates of effect. CONCLUSIONS: There is little information available from clinical trials to support many of the treatments for mechanical neck pain. In general, conservative interventions have not been studied in enough detail to assess efficacy or effectiveness adequately.

Anti-Inflammatory Agents↗
PubMed1996

Conservative management of mechanical neck disorders. A systematic overview and meta-analysis.

OBJECTIVE: This overview reports the efficacy of conservative treatments (drug therapy, manual therapy, patient education, physical medicine modalities) in reducing pain in adults with mechanical neck disorders. METHODS: Computerized bibliographic database searches from 1985 to December 1993, information requests from authors, and bibliography screenings were used to identify published and unpublished research. Applying strict criteria, two investigators independently reviewed the blinded articles. Each selected trial was evaluated independently for methodologic quality. RESULTS: Twenty-four randomized controlled trials (RCTs) and eight before-after studies met our selection criteria. Twenty RCTs rated moderately strong or better in terms of methodologic quality. Five trials using manual therapy in combination with other treatments were clinically similar, were statistically not heterogeneous (p = 0.98), and were combined to yield an effect size of -0.6 (95% CI: -0.9, -0.4), equivalent to a 16 point improvement on a 100 point pain scale. Four RCTs using physical medicine modalities were combined using the inverse chi-square method: two using electromagnetic therapy produced a significant reduction in pain (p < 0.01); and two using laser therapy did not differ significantly from a placebo (p = 0.63). Little or no scientific evidence exists for other therapies, including such commonly used treatments as medication, rest and exercise. CONCLUSIONS: Within the limits of methodologic quality, the best available evidence supports the use of manual therapies in combination with other treatments for short-term relief of neck pain. There is some support for the use of electromagnetic therapy and against the use of laser therapy. In general, other interventions have not been studied in enough detail adequately to assess efficacy or effectiveness. This overview provides the foundation for an evidence-based approach to practice. More robust design and methodology should be used in future research, in particular, the use of valid and reliable outcomes measures.

Acupuncture Therapy↗
PubMed1996

Vitamin D and calcium in the prevention of corticosteroid induced osteoporosis: a 3 year followup.

OBJECTIVE: To determine the efficacy and safety of vitamin D 50,000 units/week and calcium 1,000 mg/day in the prevention of corticosteroid induced osteoporosis. METHODS: A minimized double blind, placebo controlled trial in corticosteroid treated subjects in a tertiary care university affiliated hospital. The sample was 62 subjects with polymyalgia rheumatica, temporal arteritis, asthma, vasculitis, or systemic lupus erythematosus. The primary outcome measure was the percentage change in bone mineral density (BMD) of the lumbar spine in the 2 treatment groups from baseline to 36 mo followup. RESULTS: BMD of the lumbar spine in the vitamin D and calcium treated group decreased by a mean (SD) of 2.6% (4.1%) at 12 mo, 3.7% (4.5%) at 24 mo, and 2.2% (5.8%) at 36 mo. In the placebo group there was a decrease of 4.1% (4.1%) at 12 mo, 3.8% (5.6%) at 24 mo, and 1.5% (8.8%) at 36 mo. The observed differences between groups were not statistically significant. The difference at 36 mo was-0.693% (95% CI -5.34, 3.95). CONCLUSION: Vitamin D and calcium may help prevent the early loss of bone seen in the lumbar spine as measured by densitometry of the lumbar spine. Longterm vitamin D and calcium in those undergoing extended therapy with corticosteroids does not appear to be beneficial.

Adrenal Cortex Hormones↗