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C H Goldsmith

Publications and source records attributed to C H Goldsmith.

At least 55 records · Page 3Linked to original sources
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↗
PubMed1996

The Juvenile Arthritis Functional Status Index (JASI): a validation study.

OBJECTIVE: To evaluate aspects of reliability and validity of the Juvenile Arthritis Functional Status Index (JASI). We developed this questionnaire to assess a variety of daily living and functional mobility tasks in children with juvenile rheumatoid arthritis (JRA). JASI part I consists of 100 functional items divided into 5 activity categories (self-care, domestic, mobility, school, extracurricular). A 7 point degree of difficulty rating scale is used for responses. JASI Part II is a priority function section within which the child identifies and scores important activities for improvement. METHODS: The JASI was administered to 30 children with JRA 8 to 19 years of age at baseline, 3 weeks, and 3 months to determine test-retest reliability. Various rheumatology measures were used to evaluate the JASI construct validity. RESULTS: Reliability of JASI Part I was excellent (intraclass correlation coefficients > or = 0.95) for both retest intervals. Reliability was lower for respondents with mild disease than those with polyarticular disease. JASI Part I scores correlated strongly with rheumatology measures including joint count, grip strength, hip synovitis, timed walk and run. ACR functional class, and range of motion (r > 0.50), indicating construct validity. There was fair to good agreement between scores from the child's self-report and those from therapist observation of the child's abilities on the same activities. This provides evidence that children as young as 8 years of age can realistically report on function on their own. In JASI Part II, respondents identified a mean of 5.9 functional items in the baseline priority activity list. Test-retest reliability for JASI Part II was fair (kappa = 0.57). Further work is needed to determine the most reliable and sensitive response sequence for evaluating change in priority functions with JASI Part II. CONCLUSION: JASI Part I is a reliable and valid functional measure for school age children and adolescents with JRA. Research is under way to evaluate responsiveness to change. Comparisons will be made with shorter JRA functional measures to determine differences in sensitivity.

Activities of Daily Living↗
PubMed1995

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↗
PubMed1995

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↗
PubMed1995

Experience in the development of a postmarketing surveillance network: the pharmacy medication monitoring program.

OBJECTIVE: To describe the pilot and early implementation phase of a system for assembling and recruiting cohorts of patients taking selected prescription medications and prospectively monitoring them for new health events. DESIGN: Prospective observational study, based on telephone interviews, of 1475 patients filling prescriptions for a nonsteroidal antiinflammatory drug (NSAID). Patients were interviewed by telephone using trained interviewers at a central site. Hospitalizations and deaths were followed up and reviewed by an independently physician. SETTING: Community setting in a region of Hamilton, Ontario, Canada. PARTICIPANTS: All consenting patients filling new or repeat prescriptions for NSAIDs at participating pharmacies. MAIN OUTCOME MEASURES: The authors report on the development and assessment of systems for: (1) ongoing recruitment of patients through community pharmacies; (2) data transfer from pharmacies to the coordinating center; (3) surveying patients; (4) classifying, coding, and evaluating new health events; and (5) following up on new serious adverse events. RESULTS: Fifty-one percent of patients approached were recruited, and 83% of these provided completed interviews. For patients picking up their own medications, pharmacy workload varied from 4 to 10 minutes per patient approached. Nineteen percent of patients reported having a new health problem or unusual symptom at the initial telephone interview. Reported health-related events were similar to those described in other studies of NSAIDs. CONCLUSIONS: Most aspects of the monitoring system performed well. One limitation was the low recruitment rate for patients who did not directly drop off or pick up their own prescriptions. Even so, this method of patient accrual may complement alternative monitoring programs.

Adverse Drug Reaction Reporting Systems↗
PubMed1995

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↗
PubMed1995

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↗
PubMed1995

The reliability of examination for tenderness in patients with myofascial pain, chronic fibromyalgia and controls.

OBJECTIVE: To establish the reliability with which tenderness could be evaluated in patients with chronic myalgias, using dolorimetry and palpation. METHODS: Three blinded examiners using pressure dolorimetry and digital palpation compared 19 paired tender points and 8 paired control points in 4 matched groups of 6 patients with fibromyalgia (FM), myofascial pain, pain controls, and healthy controls. RESULTS: Good interrater and test-retest reliability were found for dolorimetry scores. There were significant differences in tenderness ratings by dolorimetry between the diagnostic groups, with the patients with FM and myofascial pain having the greatest tenderness, the normals having the least tenderness, and the pain controls having tenderness levels midway between the patients with FM or myofascial pain and the normals. In all patients, control points had higher pain thresholds than tender points. One-third of patients with localized pain complaints demonstrated a significant relationship between region of clinical pain complaint and measured tenderness thresholds by dolorimetry. In ratings of tenderness by digital palpation, there was very good intrarater reliability over 26 of 27 paired points, and good interrater reliability at 75% of the points. One-half of patients with localized pain complaints demonstrated a significant relationship between region of clinical pain complaint and number of tender points by palpation. CONCLUSION: Both dolorimetry and palpation are sufficiently reliable to discriminate control patients from patients with myofascial pain and FM, but may not discriminate patients with myofascial pain from those with FM. Neither method appears to correlate well with the location of the clinical pain complaint, regardless of diagnosis.

Adult↗
PubMed1994

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↗
PubMed1994

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↗
PubMed1994

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↗
PubMed1994

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↗