Biomedical subjects

C H Goldsmith

Publications and source records attributed to C H Goldsmith.

At least 73 records · Page 4Linked to original sources

PubMed1994

Intermittent cyclic therapy with etidronate in the prevention of corticosteroid induced bone loss.

OBJECTIVE: To assess the potential efficacy of intermittent cyclic therapy (ICT) with etidronate in the treatment of patients with corticosteroid induced osteoporosis. METHODS: Cohort study in a tertiary care university affiliated hospital in corticosteroid treated patients, with polymyalgia rheumatica, asthma, systemic lupus erythematosus, rheumatoid arthritis, or temporal arteritis, examining the effects of ICT etidronate. Patients were included if they were taking corticosteroids for a minimum of one year. Comparison patients were those who had been taking corticosteroids for a minimum of one year and who had not been treated with etidronate or other medication which might alter bone metabolism. A total of 68 patients were included from 253 considered. The mean (SD) dose of prednisone in the ICT etidronate treated patients was 9.3 (6.2) mg and in the comparison patients 9.4 (5.9) mg. The duration of prednisone therapy was 7.8 (5.8) years and 3.4 (4.2) years, respectively (p2 < 0.001). An analysis of covariance demonstrated that this difference did not alter our primary outcome measure. The primary outcome measure was the difference in the percentage change from baseline to one year of followup in bone mineral density (BMD) of the lumbar spine between treatment and comparison groups. RESULTS: ICT etidronate resulted in a statistically significant and clinically important increase in BMD. The BMD of the lumbar spine increased by 3.82% (0.65%), [95% confidence interval (CI), 2.51 to 5.14%] in the 35 ICT etidronate treated patients and decreased by 1.78% (0.76%), [95% CI, -3.34 to -0.23%] in the 33 comparison patients after 12 months (p2 < 0.0001). CONCLUSIONS: ICT etidronate prevented loss of vertebral bone density in patients with corticosteroid induced osteoporosis. Controlled, double blind, prospective trials with longer followup are needed to confirm these results and to demonstrate that increases in bone mass translate into decreased fracture rates.

Adrenal Cortex Hormones↗

PubMed1994

[Estimation of benefits and risks of the treatment of rheumatoid polyarthritis with glucocorticoids using the health-related quality of life measurements].

The purpose of this study was to use the utility approach to evaluate the risks and benefits of corticosteroid therapy in rheumatoid arthritis patients. The utility approach provides us with a quantitative measure of the value or preference a patient attaches to his overall health status defined on a scale from perfect health (1) to death (0). Benefits and toxicity are combined into a number reflecting the patients combined assessment of the benefits of treatment and the side-effects associated with it. Utility of 3 scenarios (rheumatoid arthritis patients treated respectively with no, 5 mg/day and 15 mg/day of prednisone) were determined through the time trade-off (TTO) and thermometer scale (TS) techniques. Twenty-five rheumatoid arthritis patients selected at random among subjects attending an outpatient clinic and 25 rheumatologists were interviewed using visual aids. Treatment with 15 mg/d prednisone was assigned the highest utilities by both patients and physicians. Coefficients of correlation between thermometer scale and time trade-off utilities were 0.675 (p < 0.01) for physician-assigned utilities and 0.518 (p < 0.05) for patient-assigned utilities. Medical decisions concerning rheumatoid arthritis patients should take into account the preferences of patients and physicians.

Adult↗

PubMed1994

Sensitivity to change of 3 Systemic Lupus Erythematosus Disease Activity Indices: international validation.

OBJECTIVE: Three indices, the SLE Disease Activity Index (SLEDAI), the Systemic Lupus Activity Measure (SLAM) and the British Isles Lupus Assessment Group (BILAG), have been found to be reliable and valid measures of disease activity in patients with systemic lupus erythematosus (SLE). Our aim was to investigate their use and comparative ability to assess change in disease activity over time. METHODS: Clinical and laboratory features of 8 patients with SLE on each of 3 consecutive visits were abstracted and sent in 3 separate packages to physicians from 8 centers. The order of the patient visit summaries was randomized, and the 3 indices rated in one of 6 specific sequences. RESULTS: The 3 indices were significantly (p < 0.01) correlated: SLEDAI/SLAM = 0.61, BILAG/SLAM = 0.55, SLEDAI/BILAG = 0.35. The sequence presented, the order of patients and order of index scoring did not contribute significantly (p > 0.05) to the variation of any of the 3 indices. All 3 indices detected differences among patients (p < 0.01). Differences between visits were detectable with SLEDAI (p = 0.04) but not with SLAM or BILAG: CONCLUSION: Our study confirms that the SLEDAI, SLAM and BILAG are comparable disease activity measures. SLEDAI appears to be sensitive to change in disease activity over time.

Computers↗

PubMed1994

Development of a self-report functional status index for juvenile rheumatoid arthritis.

OBJECTIVE: There are few functional indices available for juvenile rheumatoid arthritis (JRA). Our goal was to develop a reliable, valid and responsive self-report physical functional status index for individuals with JRA, ages 8-18 years. METHODS: Activity (item) generation by interview of children, parents, teachers, clinicians yielded 280 items. Categories of self-care, domestic, mobility, school, and extracurricular were chosen by clinicians. Twelve clinicians sorted the items into categories. Item reduction was by these clinicians who rated items for common problems in JRA, importance of performance, and potential for change. RESULTS: Ninety-nine items were retained. A separate section was designed for respondents to identify their priority activities. Content validity of the questionnaire, the Juvenile Arthritis Self-Report Index (JASI), was evaluated by 17 different clinicians. One item was added and none eliminated; all rated the index as a credible functional measure for JRA. CONCLUSION: The JASI has been rigorously developed, and has demonstrated content validity. Index validation is being completed.

Activities of Daily Living↗

PubMed1994

Can specially trained physiotherapists improve the care of patients with rheumatoid arthritis? A randomized health care trial.

OBJECTIVE: To examine the influence of specially trained physical therapists (PT) on patterns and outcome of care, relating to inflammatory disease status as measured by disease outcomes. METHODS: Fifty-four patients were allocated at random to specially trained PT, and to traditional PT. Outcomes were measured at baseline and at 4 months by independent assessors. RESULTS: There was no statistically significant or clinically important difference in outcome between the 2 groups. The advice of specially trained PT significantly improved compliance with salicylates. CONCLUSION: The effectiveness of this therapy was not demonstrated, likely due to incomplete compliance along the therapeutic chain, beginning with the PT's report, through a variety of possible responses, and ending with patient outcome.

Adolescent↗

PubMed1994

The effects of comprehensive home physiotherapy and supervision on patients with ankylosing spondylitis--an 8-month followup.

OBJECTIVE: Our previous randomized clinical trial showed a 4-month home physiotherapy program was effective for patients with ankylosing spondylitis. This followup study reports on 22 control patients who received the previously withheld treatment and 24 experimental patients who received followup treatment as needed. METHODS: The primary outcome measure was spinal mobility measured by fingertip-to-floor distance using a portable measuring device specially designed and validated for this study. RESULTS: Following treatment, fingertip-to-floor distance did not change in control patients (P2 = 0.145). Between 4 and 8 months, fingertip-to-floor distance did not change in experimental patients (P2 = 0.143); however, initial improvement achieved was maintained. The experimental group at 4 months was better than the control group at 8 months (P2 = 0.038). CONCLUSION: The home physiotherapy treatment program must be delivered as rigorously as it was in the initial trial to be effective. The benefit from this treatment program can be maintained with very little intervention.

Follow-Up Studies↗

PubMed1993

Measuring abdominal muscle weakness in patients with low back pain and matched controls: a comparison of 3 devices.

OBJECTIVE: To compare 3 hand held devices used to measure isometric abdominal muscle strength: the adapted sphygmomanometer, the vigorometer and the Penny & Giles myometer. METHODS: Subjects were men, aged 22 to 43 years. Fifteen had a history of low back pain and 18 age matched controls had no low back pain. The test position was a half sit-up at 45 degrees, knees at 90 degrees, feet secured. The single observer applied pressure with one of the devices downwards, just below the sternal notch, while the patient maintained that position. Order of methods was random, controlled by a series of 3 x 3 Latin squares. The vigorometer and myometer were calibrated to mm Hg. Even numbered subjects were tested twice; odd numbered subjects had their measurements timed. RESULTS: One subject was unable to complete the study. Subjects with low back pain had abdominal muscle strength 38.8 mmHg lower than healthy controls [F(1,62) = 72.84, P2 < 0.01]. Order of measurements was similar [F(2,62) = 1.19, P2 = 0.31]; instruments differed [F(2,62) = 27.94, P2 < 0.01]. Duplicate readings were similar (minimum P2 > 0.10); all 3 devices detected significant differences between the 2 groups (P2 < 0.01); mean measurement time was 19 s and time to measure with each device was similar (P2 = 0.70). CONCLUSION: All 3 instruments performed equally well. Since the sphygomanometer is available at about 1/5 the cost of the vigorometer and 1/12 the cost of the myometer, it is the preferred instrument.

Abdominal Muscles↗

PubMed1993

Modelling the population health impact of musculoskeletal diseases: arthritis.

OBJECTIVE: A model adjusting for reductions in quality and quantity of life was developed to estimate the population health impact of musculoskeletal diseases. METHODS: Using arthritis as the prototype, prevalence, mortality, and severity data from a variety of sources were combined to model a hypothetical cohort of 1,000 individuals through life. Quality adjusted life years and population health expectancy were calculated for those with arthritis and compared to the general population. RESULTS: Without adjusting for quality of life, a cohort of 1,000 women and 1,000 men at age 15 years could expect 65,010 and 58,735 life years, respectively. Adjusting for quality of life, women with arthritis could expect 61,719 life years, and men 57,123 life years. The unadjusted population health expectancy was 65.0 for girls and 58.7 for boys (at age 15 years). Adjusting for quality of life, the population health expectancies were 61.7 and 57.1, years for women and men, respectively. CONCLUSION: Using this model, the typical adult woman with arthritis can expect to lose 3.3 healthy years of life, and a man, 1.6 healthy years of life. Overall, the model provided a general methodology for determining the population health impact of musculoskeletal diseases. In addition, it is hoped that the methodology will stimulate further research into this area, raise awareness about the uses and limitations of currently available data, and provide a useful model for monitoring the impact of interventions.

Adolescent↗

PubMed1993

Reliability of the modified-modified Schöber and double inclinometer methods for measuring lumbar flexion and extension.

BACKGROUND AND PURPOSE: The primary purpose of this study was to determine the reliability of lumbar flexion and extension range-of-motion measurements obtained with the modified-modified Schöber and the double inclinometer methods on subjects with low back pain. SUBJECTS: Fifteen patients (8 women, 7 men), aged 25 to 53 years (mean = 35.7, SD = 9.9), with chronic low back pain were measured by three physical therapists with 3 to 12 years (mean = 8.3, SD = 4.7) of clinical experience. METHODS: The therapists used the modified-modified Schöber and double inclinometer techniques to measure, in random order and on two occasions, the subjects' lumbar flexion and extension. RESULTS: Pearson Product-Moment Correlation Coefficients for test-retest reliability for the modified-modified Schöber technique varied from .78 to .89 for lumbar flexion and from .69 to .91 for extension; for the double inclinometer method, Pearson correlation coefficients varied from .13 to .87 for lumbar flexion and from .28 to .66 for extension. Analysis of variance-derived intraclass correlation coefficients for interrater reliability for the modified-modified Schöber technique were .72 for flexion and .76 for extension; for the double inclinometer technique, they were .60 for flexion and .48 for extension. CONCLUSION AND DISCUSSION: The modified-modified Schöber method thus appears to be a reliable method for measuring lumbar flexion and extension for patients with low back pain, whereas the double inclinometer technique needs improvement.

Adult↗

PubMed1993

Criteria for clinically important changes in outcomes: development, scoring and evaluation of rheumatoid arthritis patient and trial profiles. OMERACT Committee.

OBJECTIVE: To further the development of criteria for clinically important changes in outcomes seen in rheumatoid arthritis (RA) patients and trials. METHODS: Small group discussions and voting on specially designed profiles based on a 6 factor 2 level factorial design for changes seen in patients and trials. The purpose was to bring out the implicit opinions of participants on these issues, to complement the explicit opinions expressed in the OMERACT questionnaire. This took place at a conference of rheumatologists, methodologists, biostatisticians, regulatory, pharmaceutical and biotechnology industry personnel with an interest in therapies for patients with RA. Data from patients with RA and randomized clinical trials of second line drugs in patients with RA formed the basis to create 64 patient profiles and 64 trial profiles. The profiles contained information on changes in 6 measures: swollen joint count, tender joint count, pain, patient global assessment, physician global assessment and physical disability. The profiles were prepared on 4" x 5" cards and presented to the participants in packages of 64 in random order, in 2 different group sessions. Participants were assigned to 8 groups that contained a mix of all types of participants, with a majority of clinicians in each group. In the patient profile session, individual participants scored whether the profile represented important improvement. In the trial profile session, participants did likewise for important difference between the drugs. After structured discussion the group then voted: consensus was defined as agreement by at least 70% of the group. We decided that an important improvement or difference was present in the profiles on which at least 6 of the 8 groups had achieved consensus. The changes in the profiles showing important improvement or difference can be used to suggest minimum criteria for each of the 6 measures. RESULTS: The lower quartile of the change present in the patient profiles with important improvement varied from 17% (swollen joints) to 49% (disability); the median of these quartiles was 36%. The lower quartile of the differences present in the trial profiles with important differences varied from 13% (tender joints) to 26% (physician global); the median of these quartiles was 18%. CONCLUSIONS: This approach has provided a beginning for less arbitrary definition of criteria for important change in patients and trials. It might be suggested that for patients, an improvement of at least 36% should be clinically important, while an active drug needs to be at least 18% better than placebo to be clinically important.

Arthritis, Rheumatoid↗

PubMed1993

Interpretation and power of a pooled index.

OBJECTIVE: To describe, illustrate, provide statistical rationale and give clinical examples of the concept of a pooled index. METHODS: No explicit design. Randomized control trials of patients diagnosed with rheumatoid arthritis from Rheumatic disease clinics, tertiary care hospitals and communities are used as examples to illustrate the pooled index technique. Interventions in rheumatic disease unit inpatient and outpatient care, occupational therapy and physiotherapy provided by Arthritis Society Therapists in the community were compared. Variables included active joint count, morning stiffness in min, mean of right and left grip strength in mm Hg, erythrocyte sedimentation rate in mm/h, a functional change score, and a pooled index. RESULTS: The pooled index in each study detected a clinically important effect while individual measures were generally not able to declare the effect statistically significant. CONCLUSIONS: The pooled index is a more powerful clinical outcome than any individual measure provided it is computed from at least 2 relevant clinical outcome measures that have low correlation with each other.

Arthritis, Rheumatoid↗

PubMed1992

Multicenter study of general anesthesia. III. Predictors of severe perioperative adverse outcomes.

Little information is available about the incidence of severe adverse outcomes, and even less information is available about the identification and quantification of independent predictors of severe perioperative adverse outcomes. The purpose of this study was to identify and quantitate independent predictors of severe perioperative adverse outcomes in a prospective randomized clinical trial of general anesthesia in 17,201 patients. Twenty-nine prognostic variables for 15 severe outcomes in 847 patients were tested by multiple stepwise logistic regressions from which 20 significant (P less than 0.05) predictors were identified. A history of cardiac failure or myocardial infarction less than or equal to 1 yr; ASA physical status 3 or 4; age greater than 50 yr; cardiovascular, thoracic, abdominal or neurologic surgery; and the study anesthetics were significant predictors of "any severe outcome, including death." There were 17 significant predictors for 10 severe cardiovascular outcomes in 608 patients, including a history of ventricular arrhythmia, hypertension, cardiac failure, myocardial ischemia, myocardial infarction less than or equal to 1 yr or myocardial infarction greater than 1 yr, and smoking; ASA physical status; age; cardiovascular, thoracic, abdominal, eyes-ears-nose-throat/endocrine, neurologic, musculoskeletal, or gynecologic surgery; and the study anesthetics. There were 9 significant predictors for 4 severe respiratory outcomes in 163 patients, including a history of cardiac failure, myocardial ischemia, or chronic obstructive pulmonary disease; obesity; smoking; male gender; ASA physical status; abdominal surgery; and the study anesthetics. Colinearity between related prognostic variables (such as disease and ASA physical status) was assessed using progressively segregated groups of variables in eight stepwise logistic regressions. We conclude that the comprehensive stepwise logistic regression of 29 prognostic variables reported here provides a valid estimate of the risks of severe perioperative outcomes associated with general anesthesia.

Anesthesia, General↗

PubMed1992

Observer variation in an audit of charts of patients with rheumatoid arthritis.

Arthritis Society physiotherapists (PTs) in Ontario adopted Problem Oriented Records (POR) to monitor patient care; goals were to encourage patient specific treatment plans and standardized records. After nine months in practice, the POR system was evaluated by an audit on charts of patients with Rheumatoid Arthritis. Audit teams of two PTs were created within each of five geographic areas. Auditors attended an audit instruction workshop. Two charts, selected randomly from the discharged patients of each of 38 therapists, were independently scored on 56 items by an audit team. The extent of agreement within the auditor team (observer variation) was measured, and adequacy scores computed for each chart. Adequate reliability of the audit instrument was established before examination of adequacy scores and making inferences about quality of care. The auditor agreement measures (kappa) varied from 0.13 to 0.97, mean = 0.74 and SD = 0.16; these estimates were indicative of adequate reliability of the audit form, although agreement scores were different amongst the five areas (P2 less than .01). POR adequacy scores varied from 10.0 to 93.1, mean = 64.5 and SD = 16.9. There were no differences in adequacy scores amongst the five areas (P2 = .61). To reduce observer variation, increased pre-audit emphasis is needed on auditor guidelines and training for items relating to assessment findings, problem identification, and treatment planning.

Analysis of Variance↗

PubMed1992

Rapid facile solid-phase immunobead assay for screening ciguatoxic fish in the market place.

The precision of the solid-phase immunobead assay (Ciguatect) to detect toxins associated with ciguatera poisoning have been evaluated through analysis of toxic and non-toxic fish obtained from fishing areas around the Hawaiian Islands. The Ciguatect test kit has been optimized for application to field/marketplace screening of ciguatoxic fish. Twelve parrot, surgeon, and amberjack fish fillet and fish extract test portions containing various concentrations of toxins were distributed to participating laboratories for analysis. The presence or absence of ciguatera-related toxins is determined by binding the toxins to a membrane attached to a plastic strip and exposing the toxin ladened membrane to a monoclonal antibody-colored latex bead complex which has a high specificity for ciguatera-related toxins. The intensity of the color on the membrane denotes the presence of the toxins in the fish or fish extract. Toxic components in the fish were confirmed by extraction, column purification, and toxicity testing using the brine shrimp (Artemia sp.) assay. Okadaic acid was used to standardize both the S-PIA and brine shrimp assays. For determination of ciguatoxin and related polyether toxins in parrot, surgeon, and amberjack fish fillets, the relative standard deviations for repeatability (RSDR) were 13.5, 9.0 and 4.3%, respectively, and the relative standard deviations for reproducibility (RSDR) were 44.4, 29.7 and 14.3%, respectively, for concentrations ranging from 1-4 ng/test strip. For determination of ciguatoxin and related polyether toxins in parrot, surgeon, and amberjack fish extracts, the RSDR were 5.8, 4.8, and 3.7%, respectively, and the RSDR were 11.9, 9.9, and 7.6%, respectively, for concentrations ranging from 3-5 ng/test strip.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

PubMed1992

Physical disability among Canadians reporting musculoskeletal diseases.

About one million Canadian adults are estimated to have physical disabilities attributed to a musculoskeletal condition, a prevalence of 50.1/1,000 adults (all rates expressed/1,000). The specific musculoskeletal disease rates were arthritis/rheumatism (27.2), back (16.2), "other" (4.6), trauma (3.6) and bone (0.6). More women reported disabling musculoskeletal disease (61.0 versus 38.6, respectively). Prevalence rates increased with age from 6.2 among Canadians aged 15-24 years, to 264.7 aged 85 years and over. Limitations of mobility were more common than those of agility. Adults in institutions reported more disabilities than did adults in households (means 7.7 and 4.4, respectively).

Adolescent↗

PubMed1992

Effectiveness and efficiency of selective vs universal screening for chlamydial infection in sexually active young women.

BACKGROUND: Since chlamydial cervicitis is not associated with specific complaints, screening asymptomatic women is an important initiative to prevent pelvic inflammatory disease and its sequelae. Compared with universal screening, selective screening is less costly but less effective so the cost savings vs the consequences of missing infected women need to be weighed carefully. METHODS: In two family planning clinics, 1002 women were surveyed for chlamydial infection (prevalence, 7%) and its predictors to determine whether universal or selective screening is the most efficient strategy. Two rules for the selection of patients were determined by logistic regression modeling and their relative efficiencies were compared by incremental cost-effectiveness and sensitivity analysis. The validity of the screening rules was tested in 191 students attending a university health clinic. RESULTS: If those with cervical friability, suspicious discharge, urinary frequency, or intermenstrual bleeding had been tested, 55.3% of all women would have been screened and 83.3% of all cases would have been detected. If those reporting a new sex partner in the preceding year had also been tested, 75.4% would have been screened, identifying 93.3% of all cases. The predictive power and practicality of the selection rules were validated in the university health clinic sample. Sensitivity analyses showed selective screening using cervical enzyme immunoassay with blocking confirmation was efficient if the prevalence of chlamydial infection was 16% or less, 11% or less, or 5% or less depending on whether base analyses, overestimated costs, or worst performance scenarios, respectively, were used. CONCLUSIONS: Selective screening based on four or five predictors and confirmed cervical enzyme immunoassay is an effective and efficient strategy in low prevalence settings.

Adult↗

PubMed1992

Cyclosporine nephrotoxicity in rheumatoid arthritis: no effect of short term misoprostol treatment.

We assessed the effect of the prostaglandin E1 analog misoprostol on cyclosporine nephrotoxicity in patients with rheumatoid arthritis (RA). Thirteen patients with RA were given cyclosporine with misoprostol tablets, 800 micrograms/day for one week in a randomized, double blind, placebo controlled crossover trial. All had cyclosporine nephrotoxicity, documented by an increase in serum creatinine of at least 15% over the values before the start of cyclosporine treatment. Mean glomerular filtration rate (GFR) (single shot 51Cr-EDTA plasma clearance) at baseline was 77.3 ml/min (SD, 22.0). After misoprostol, it was 80.0 ml/min (SD, 18.9); after placebo, 79.1 ml/min (SD, 20.0). None of these changes were statistically significant. Serum creatinine levels and whole blood cyclosporine levels were also unchanged. Power to detect at least a 5 ml/min rise in GFR was 0.92. Short term misoprostol treatment does not improve the GFR of patients with RA on cyclosporine.

Adult↗

PubMed1992

Crosscultural validation and reliability of 3 disease activity indices in systemic lupus erythematosus.

Rheumatologists from 4 countries, representing 8 rheumatology centers, tested 3 systemic lupus erythematosus (SLE) disease activity indices: the SLE Disease Activity Index (SLEDAI) from Toronto; the Systemic Lupus Activity Measure (SLAM) from Boston and the British Isles Lupus Assessment Group (BILAG) for their reproducibility and validity in the assessment of real patients. Seven patients representing a spectrum of disease manifestations and activity were each examined by 4 of 7 observers from all centers except Toronto, using a Youden square design. Each observer completed all 3 indices and a category rating scale for disease activity on each of the 4 patients seen. All 3 indices detected differences among patients. There was no detectable observer effect among the 7 observers with each of the 3 indices. There was a detectable order effect with the SLAM. The 3 indices are comparable and reproducible for evaluating disease activity in SLE.

Boston↗