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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

Reliability of the Gross Motor Performance Measure.

BACKGROUND AND PURPOSE: The reporting of reliability coefficients and the method of their determination is expected of test developers. The purpose of this study was to estimate the interrater, intrarater, and test-retest reliability of the Gross Motor Performance Measure, a measure of quality of movement designed to accompany the Gross Motor Function Measure. SUBJECTS: Subjects were 28 children (25 with cerebral palsy, 2 nondisabled, 1 with head injury) between the ages of 1 and 10 years. METHODS: Reliability data were obtained from assessments of 19 therapists. RESULTS: Intraclass correlation coefficients for reliability varied from .92 to .96 for the total scores and from .84 to .94 for the five attribute scores. CONCLUSION AND DISCUSSION: When the Gross Motor Performance Measure was administered by therapists who are familiar with the Gross Motor Function Measure and had a 1-day training workshop, reliability of the total scores was above recommended minimums. Scores of single attributes were less reproducible.

Cerebral Palsy

The Gross Motor Performance Measure: validity and responsiveness of a measure of quality of movement.

BACKGROUND AND PURPOSE: This article presents the results of a study to validate a measure of gross motor performance for its capacity to detect changes in the quality of movement in children with cerebral palsy aged 0 to 12 years. SUBJECTS AND METHODS: On two occasions, 4 to 6 months apart, physical therapists from three children's treatment centers assessed 106 children with cerebral palsy, 18 children who had sustained an acute head injury, and 29 nondisabled children. Validity was demonstrated by comparing changes on the measure across diagnoses, severity, and age groups. RESULTS: Several a priori hypotheses were supported; however, relationships with parent and therapist ratings were not clearly demonstrated. CONCLUSION AND DISCUSSION: The measure was found to be differentially responsive to changes in "stable" and "responsive" groups.

Analysis of Variance

Interactive conference voting. The OMERACT II Committee. Outcome Measures in Rheumatoid Arthritis Clinical Trial Conference.

We describe and analyze opinion polling results from interactive voting procedures undertaken before and after presentations during the Outcome Measures in Rheumatoid Arthritis Clinical Trials Conference (OMERACT II) in Ottawa, Canada, June 30-July 2, 1994. The scoring procedure was a matched voting design; when a participant used the same keypad at the beginning and end of voting, change within a participant could be estimated. Participants, experienced in the rheumatic diseases included clinicians, researchers, methodologists, regulators, and representatives of the pharmaceutical industry. Patients under consideration were those with any rheumatic diseases. Questions were constructed to evaluate the change in voting behavior expected from the content of the presentation. Statistically significant and substantively important changes were evident in most questions.

Arthritis, Rheumatoid

Salsalate, a nonacetylated salicylate, is as efficacious as diclofenac in patients with rheumatoid arthritis. Salsalate-Diclofenac Study Group.

OBJECTIVE: To investigate the efficacy of salsalate, a nonacetylated salicylate, in the treatment of patients with rheumatoid arthritis (RA). METHODS: Three hundred and one patients meeting the ACR criteria for RA were drawn from 16 centers. After withdrawal of nonsteroidal antiinflammatory drugs (NSAID) and subsequent flare, patients were randomized to receive either salsalate or diclofenac for 8 weeks, according to a double blind, double dummy protocol. Initial doses of salsalate 3.0 g/day and diclofenac 75 mg/day were titrated for the first 5 weeks. The primary outcome measure was a multivariate analysis at 8 weeks of tender joint count, pain, visual analog scale score, and physician's global assessment. RESULTS: One hundred and ninety patients completed the study. The mean stabilized dose of salsalate was 3.55 g/day, and that of diclofenac 112 mg/day. Discontinuations were due to lack of efficacy (17 salsalate vs 15 diclofenac); adverse events [19 salsalate (mainly tinnitus and hearing loss; p = 0.0001 and p = 0.04, respectively) vs 9 diclofenac]; laboratory abnormalities (3 salsalate vs 1 diclofenac); and other reasons, including protocol violations, intercurrent illness, and personal factors (24 salsalate vs 23 diclofenac). Both treatments produced significant improvement from flare (p < 0.0001). Post hoc power analysis showed that the study had sufficient power (0.60 to 0.90) to detect clinically important differences between the 2 drugs in the primary outcome measures; however, no statistically significant (p = 0.29) or clinically important treatment differences were recorded. Other than a difference in erythrocyte sedimentation rate that favored salsalate, there were no significant differences in secondary outcome measures between the 2 groups. All outcomes showed a tendency for more improvement with salsalate. CONCLUSION: Salsalate is as efficacious as diclofenac. Salsalate may be considered an alternative to other NSAID in the first line treatment of patients with RA.

Aged

Lymphoid tissues induce NGF-dependent and NGF-independent neurite outgrowth from rat superior cervical ganglia explants in culture.

Induction of neurite outgrowth from superior cervical ganglia (SCG) by rat lymphoid tissues was studied using a tissue culture model. Neonatal rat SCG were cultured with 6-12-week-old rat thymus, spleen, or mesenteric lymph node (MLN) explants in a Matrigel layer, in defined culture medium without exogenous nerve growth factor (NGF). SCG were also co-cultured with neonatal rat heart (as positive control) or spinal cord (SC; as negative control). To determine whether inflammation affects the ability of lymphoid tissues to induce neurite outgrowth, we also examined MLN at various times after infecting rats with Nip-postrongylus brasiliensis (Nb-MLN). In one series of experiments, a single lymphoid tissue explant was surrounded by four SCG at a distance of 1 mm. The extent of neurite outgrowth was determined by counting the number of neurites 0.5 mm away from each ganglion at several time points. Adult thymus and, to a lesser extent, spleen had strong stimulatory effects on neurite outgrowth from SCG after 12 hr or more in culture. For thymus tissue, this was similar to the positive control heart explants. MLN from normal rats had minimal effect on neurite outgrowth; however, Nb-MLN showed a time-dependent enhancement of the neurite outgrowth, maximal at 3 weeks after infection. The relative efficacy of neurite outgrowth induction (heart > or = thymus > or = Nb-MLN > or spleen > or = MLN > or = SC) was confirmed in a second series of experiments where one SCG was surrounded by three different tissue explants. We then examined the role of 2.5S NGF, a well-known trophic factor for sympathetic nerves, in the lymphoid tissue-induced neurite outgrowth. Anti-NGF treatment of co-cultures of SCG and heart almost completely blocked the neurite outgrowth. Anti-NGF also significantly inhibited thymus- and spleen-induced neurite outgrowth, but not as effectively as heart-induced neuritogenesis (93, 80, and 77% inhibition at 24 hr; 86, 70, and 68% inhibition at 48 hr for heart, thymus, and spleen, respectively). On the other hand, anti-NGF inhibited only 8% of neurite outgrowth induced by 3-week post-infection Nb-MLN at 24 hr, and 41% at 48 hr. These data show that several adult rat lymphoid tissues exert neurotrophic/tropic effects. The predominant growth factor in thymus and spleen is NGF, while Nb-MLN produces factor(s) which is (are) immunologically distinguishable from NGF.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals

Platelet concentrates stored for 5 days in a reduced volume of plasma maintain hemostatic function and viability.

BACKGROUND: Platelet concentrates prepared from whole blood are generally suspended in a standard volume of 50 to 60 mL of plasma and can be stored thus at 20 to 24 degrees C for up to 5 days. In vitro studies suggested that this plasma volume could be reduced to 30 to 35 mL without impairing platelet function. STUDY DESIGN AND METHODS: This study evaluated whether platelets stored for 5 days in a reduced volume (30-35 mL) of plasma maintained their in vivo viability, hemostatic function, and recovery in recipients. Paired autologous platelet survival studies were done in 20 adult volunteers to assess platelet viability. A rabbit ear bleeding-time model was used to compare the hemostatic effectiveness of human platelet concentrates stored for 5 days in the standard or reduced volume of plasma. Platelet recovery was compared in thrombocytopenic hospital patients. RESULTS: Paired platelet survival studies indicated no significant difference between the values in platelet concentrates stored for 5 days in the reduced volume of plasma and the values in those stored in the standard volume. In the animal model, there was no significant difference in the bleeding times achieved by either set of platelet concentrates. The platelet count increments in thrombocytopenic patients were measured. The platelet count increments in patients who received reduced-volume platelet concentrates were as good as the increments achieved in patients given standard-volume concentrates. CONCLUSION: The in vivo viability, recovery, and hemostatic function of platelets collected in polyvinylchloride plastic containers and stored in 30 to 35 mL of plasma for 5 days are maintained as well as those of platelets stored in 50 to 60 mL of plasma.

Adult

Training users in the gross motor function measure: methodological and practical issues.

BACKGROUND AND PURPOSE: The Gross Motor Function Measure (GMFM) is a criterion-referenced observational measure for assessing change in gross motor function for children with cerebral palsy (CP). The purposes of this report are to present data on the effects of training pediatric developmental therapists to administer and score the GMFM and to discuss some practical and methodological issues associated with training. SUBJECTS AND METHODS: A weighted kappa estimate pretraining and posttraining workshop was used to determine participants' agreement of scoring a videotaped GMFM assessment against experts' scoring of the same videotaped assessment. Several children with CP, representing a spectrum of ages, severities, and levels of function, were shown on the videotape. RESULTS: There was a significant improvement in agreement from a mean kappa of .58 to .82 (t = 15.38, df = 75, P < .001) for the first group and from .81 to .92 (t = 10.91, df = 72, P < .001) for the second group following training. CONCLUSION AND DISCUSSION: Although there are a number of advantages to using videotapes to train test users and to assess scoring reliability, this method does not evaluate participants' ability to administer the measure. Further work is needed to determine whether reliability is maintained in a clinical situation in which it is necessary to both administer and score the GMFM.

Adolescent

Can observational studies replace or complement experiment?

The therapeutic effects of interventions in patients with rheumatoid arthritis (RA) are frequently modest. In the assessment of treatments effects, variability due to a variety of sources causes problems that are best controlled by randomized clinical trials. Currently most trials give only a short term picture of RA, a chronic disease whose outcome is multidimensional. Inclusion criteria of clinical trials are frequently very strict, raising concern about the external validity of the results. More longterm data is needed to guide clinical practice. Observational studies may contribute to the body of evidence, but have inherent shortcomings. They are liable to bias and supply weaker evidence. There must be creative development of trial designs suitable for evaluating longterm outcomes. Such trials may include many of the positive features of observational studies, but should not omit the principles of randomization and controlled comparison.

Antirheumatic Agents

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

[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

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

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

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

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

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

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

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

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