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G Wells

Publications and source records attributed to G Wells.

At least 109 records · Page 6Linked to original sources
PubMed2000

Meta-analysis of treatment termination rates among rheumatoid arthritis patients receiving disease-modifying anti-rheumatic drugs.

OBJECTIVE: To summarize the evidence on treatment withdrawal rates reported in observational studies and randomized controlled trials (RCTs) of methotrexate (MTX), parenteral gold (GST), sulphasalazine (SSZ) and hydroxychloroquine (HCQ) among patients with rheumatoid arthritis (RA). METHODS: Two independent Medline searches were used to retrieve relevant studies published between 1966 and 1997. Those which disclosed information on the number of patients withdrawing from the drug were retained. Cumulative probabilities of survival on treatment were then computed using actuarial survival estimates, and differences were tested using log-rank, Wilcoxon and Cox proportional hazards tests. RESULTS: A total of 159 studies provided withdrawal information, and the numbers of patients who withdrew, in general or because of inefficacy or toxicity, could be abstracted from 110 studies contributing 142 treatment arms (MTX, 48; GST, 56; SSZ, 22; HCQ, 16). Data for HCQ were available only up to 24 months, but combined percentages of patients estimated to have continued MTX, GST or SSZ, respectively, for 60 months were 36, 23 and 22% when all failures were considered, 75, 73 and 53% when withdrawals due to lack of efficacy alone were considered, and 65, 36 and 48% when only withdrawals due to toxicity were taken into account. The Cox proportional hazards test performed on all withdrawals, after adjusting for year of publication and type of study, revealed that patients remained on MTX significantly longer than they did on the other three agents; however, the patients stayed significantly longer on GST than MTX when withdrawals for inefficacy were analysed separately. No significant differences in withdrawal rates were noted between observational studies and RCTs. CONCLUSION: Patients with RA stay significantly longer on MTX than on other disease-modifying anti-rheumatic drugs. Higher withdrawal rates among those given GST are mainly due to high toxicity, whereas the majority of withdrawals from SSZ and HCQ result from lack of efficacy. Withdrawal rates in observational studies are similar to those reported in RCTs.

Antirheumatic Agents↗
PubMed2000

Low level laser therapy for osteoarthritis and rheumatoid arthritis: a metaanalysis.

OBJECTIVE: Osteoarthritis (OA) and rheumatoid arthritis (RA) affect a large proportion of the population. Low level laser therapy (LLLT) was introduced as an alternative noninvasive treatment for RA and OA about 10 years ago, but its effectiveness is still controversial. We assessed the effectiveness of LLLT in the treatment of RA and OA. METHODS: A systematic review was conducted, following an a priori protocol, according to the methods recommended by the Cochrane Collaboration. Trials were identified by a literature search of Medline, Embase, and the Cochrane Controlled Trials Register. Only randomized controlled trials of LLLT for the treatment of patients with a clinical diagnosis of RA or OA were eligible. Thirteen trials were included, with 212 patients randomized to laser and 174 patients to placebo laser, and 68 patients received active laser on one hand and placebo on the opposite hand. Treatment duration ranged from 4 to 10 weeks. Followup was reported by only 2 trials for up to 3 months. RESULTS: In patients with RA, relative to a separate control group, LLLT reduced pain by 70% relative to placebo and reduced morning stiffness by 27.5 min (95% CI -52.0 to -2.9), and increased tip to palm flexibility by 1.3 cm (95% CI -1.7 to -0.8). Other outcomes such as functional assessment, range of motion, and local swelling were not different between groups. There were no significant differences between subgroups based on LLLT dosage, wavelength, site of application, or treatment length. In RA, relative to a control group using the opposite hand, there was no difference between control and treatment hand, but all hands were improved in terms of pain relief and disease activity. For OA, a total of 197 patients were randomized. Pain was assessed by 3 trials. The pooled estimate (random effects) showed no effect on pain (standardized mean difference -0.2, 95% CI -1.0 to +0.6), but there was statistically significant heterogeneity (p > 0.05). Other outcomes of joint tenderness, joint mobility, and strength were not significant. CONCLUSION: LLLT should be considered for short term relief of pain and morning stiffness in RA, particularly since it has few side effects. For OA, the results are conflicting in different studies and may depend on the method of application and other features of the LLLT. Clinicians and researchers should consistently report the characteristics of the LLLT device and the application techniques. New trials on LLLT should make use of standardized, validated outcomes. Despite some positive findings, this metaanalysis lacked data on how effectiveness of LLLT is affected by 4 factors: wavelength, treatment duration of LLLT, dosage, and site of application over nerves instead of joints. There is a need to investigate the effects of these factors on effectiveness of LLLT for RA and OA in randomized controlled clinical trials.

Aged↗
PubMed2000

The prevention of chronic NSAID induced upper gastrointestinal toxicity: a Cochrane collaboration metaanalysis of randomized controlled trials.

OBJECTIVE: To review the effectiveness of common interventions for the prevention of nonsteroidal antiinflammatory drug (NSAID) induced upper gastrointestinal (GI) toxicity. METHODS: Randomized controlled clinical trials (RCT) of prostaglandin analogs, H2-receptor antagonists (H2RA), or proton pump inhibitors (PPI) for the prevention of chronic NSAID induced upper GI toxicity were identified through electronic databases, the Cochrane control trials register, conference proceedings, and by contacting content experts and companies. Outcome measures investigated were endoscopic ulcers, ulcer complications, symptoms, overall dropouts, dropouts due to symptoms, and study quality. RESULTS: Thirty-four RCT met the inclusion criteria. All doses of misoprostol significantly reduced the risk of endoscopic ulcers. Misoprostol 800 microg/day was superior to 400 microg/day for the prevention of endoscopic gastric ulcers (RR 0.18, RR 0.38, respectively; p = 0.0055). A dose-response relationship was not seen with duodenal ulcers. Misoprostol caused diarrhea at all doses, although significantly more at 800 than 400 microg/day (p = 0.0012). Misoprostol was the only prophylactic agent documented to reduce ulcer complications. Standard doses of H2RA were effective at reducing the risk of endoscopic duodenal (RR 0.24, 95% CI 0.10-0.57) but not gastric ulcers (RR 0.73, 95% CI 0.50-1.09). Both double dose H2RA and PPI were effective at reducing the risk of endoscopic duodenal and gastric ulcers (RR 0.44, 95% CI 0.26-0.74 and RR 0.37, 95% CI 0.27-0.51, respectively, for gastric ulcer) and were better tolerated than misoprostol. CONCLUSION: Misoprostol, PPI, and double dose H2RA are effective in preventing chronic NSAID related endoscopic gastric and duodenal ulcers. Lower doses of misoprostol are less effective and are still associated with diarrhea. Only misoprostol 800 microg/day has been directly shown to reduce the risk of ulcer complications.

Adult↗
PubMed1999

A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group.

BACKGROUND: To determine whether a restrictive strategy of red-cell transfusion and a liberal strategy produced equivalent results in critically ill patients, we compared the rates of death from all causes at 30 days and the severity of organ dysfunction. METHODS: We enrolled 838 critically ill patients with euvolemia after initial treatment who had hemoglobin concentrations of less than 9.0 g per deciliter within 72 hours after admission to the intensive care unit and randomly assigned 418 patients to a restrictive strategy of transfusion, in which red cells were transfused if the hemoglobin concentration dropped below 7.0 g per deciliter and hemoglobin concentrations were maintained at 7.0 to 9.0 g per deciliter, and 420 patients to a liberal strategy, in which transfusions were given when the hemoglobin concentration fell below 10.0 g per deciliter and hemoglobin concentrations were maintained at 10.0 to 12.0 g per deciliter. RESULTS: Overall, 30-day mortality was similar in the two groups (18.7 percent vs. 23.3 percent, P= 0.11). However, the rates were significantly lower with the restrictive transfusion strategy among patients who were less acutely ill -- those with an Acute Physiology and Chronic Health Evaluation II score of < or =20 (8.7 percent in the restrictive-strategy group and 16.1 percent in the liberal-strategy group; P=0.03) -- and among patients who were less than 55 years of age (5.7 percent and 13.0 percent, respectively; P=0.02), but not among patients with clinically significant cardiac disease (20.5 percent and 22.9 percent, respectively; P=0.69). The mortality rate during hospitalization was significantly lower in the restrictive-strategy group (22.3 percent vs. 28.1 percent, P=0.05). CONCLUSIONS: A restrictive strategy of red-cell transfusion is at least as effective as and possibly superior to a liberal transfusion strategy in critically ill patients, with the possible exception of patients with acute myocardial infarction and unstable angina.

APACHE↗
PubMed1999

Dictated versus database-generated discharge summaries: a randomized clinical trial.

BACKGROUND: Hospital discharge summaries communicate information necessary for continuing patient care. They are most commonly generated by voice dictation and are often of poor quality. The objective of this study was to compare discharge summaries created by voice dictation with those generated from a clinical database. METHODS: A randomized clinical trial was performed in which discharge summaries for patients discharged from a general internal medicine service at a tertiary care teaching hospital in Ottawa were created by voice dictation (151 patients) or from a database (142 patients). Patients had been admitted between September 1996 and June 1997. The trial was preceded by a baseline cohort study in which all summaries were created by dictation. For the database group, information on forms completed by housestaff was entered into a database and collated into a discharge summary. For the dictation group, housestaff dictated narrative letters. The proportion of patients for whom a summary was generated within 4 weeks of discharge was recorded. Physicians receiving the summary rated its quality, completeness, organization and timeliness on a 100-mm visual analogue scale. Housestaff preference was also determined. RESULTS: Patients in the database group and the dictation group were similar. A summary was much more likely to be generated within 4 weeks of discharge for patients in the database group than for those in the dictation group (113 [79.6%] v. 86 [57.0%]; p < 0.001). Summary quality was similar (mean rating 72.7 [standard deviation (SD) 19.3] v. 74.9 [SD 16.6]), as were assessments of completeness (73.4 [SD 19.8] v. 78.2 [SD 14.9]), organization (77.4 [SD 16.3] v. 79.3 [SD 17.2]) and timeliness (70.3 [SD 21.9] v. 66.2 [SD 25.6]). Many information items of interest were more likely to be included in the database-generated summaries. The database system created summaries faster and was preferred by housestaff. Dictated summaries in the baseline and randomized studies were similar, which indicated that the control group was not substantially different from the baseline cohort. INTERPRETATION: The database system significantly increased the likelihood that a discharge summary was created. Housestaff preferred the database system for summary generation. Physicians thought that the quality of summaries generated by the 2 methods was similar. The use of computer databases to create hospital discharge summaries is promising and merits further study and refinement.

Abstracting and Indexing↗
PubMed1999

Function and health-related quality of life: results from a randomized controlled trial of leflunomide versus methotrexate or placebo in patients with active rheumatoid arthritis. Leflunomide Rheumatoid Arthritis Investigators Group.

OBJECTIVE: To assess the efficacy of leflunomide or methotrexate compared with placebo in improving function and health-related quality of life in patients with active rheumatoid arthritis (RA), and to examine correlations between response status (as defined by the American College of Rheumatology [ACR] response criteria) and improvement in these measures. METHODS: This 52-week, multicenter, doubleblind, controlled trial compared responses to the Health Assessment Questionnaire (HAQ), modified Health Assessment Questionnaire (MHAQ), Problem Elicitation Technique (PET), Medical Outcomes Study Short Form 36 (SF-36), and questions regarding work productivity among 3 treatment groups (leflunomide, methotrexate, and placebo). Improvement in the PET top 5 and SF-36 scales and component scores were compared with ACR response rates. RESULTS: Clinically meaningful and statistically significant (P<0.0001) improvement in measures of function and heath-related quality of life (MHAQ scores, all scales and disability index of the HAQ, weighted top 5 score of the PET, 5 of 8 scales and physical component score of the SF-36, and work productivity) was seen during treatment with leflunomide in comparison with placebo. Methotrexate administration resulted in significant improvements (P<0.05) in comparison with placebo in the MHAQ scores, HAQ disability index, weighted top 5 score of the PET, physical component score of the SF-36, and bodily pain scale. Compared with methotrexate, leflunomide administration resulted in significantly (P<0.01) more improvement in the MHAQ scores, 5 of 8 scales and disability index of the HAQ, weighted top 5 score of the PET, and 2 of 8 scales and physical component score of the SF-36. Improvements in the PET score, SF-36 physical component score, and work productivity correlated with the ACR responder rates of > or =20% and > or =50% improvement. CONCLUSION: Significant improvements in function and health-related quality of life occurred in patients with RA during treatment with leflunomide or methotrexate. These findings were clinically meaningful and correlated with the ACR response status.

Adjuvants, Immunologic↗
PubMed1999

Role of egg sulfolipidimmobilizing protein 1 on mouse sperm-egg plasma membrane binding.

We have shown that sperm sulfolipidimmobilizing protein 1 (SLIP1, molecular mass of 68 kDa), a sulfogalactosylglycerolipid (SGG)-binding protein, is significant in sperm-zona pellucida (ZP) interaction. The objective of this study was to localize SLIP1 on the egg and determine its role in gamete interaction. Immunofluorescence and immunoprotein A gold electron microscopy localized SLIP1 to the egg plasma membrane. In vitro gamete binding, using zona-free eggs preincubated with antiSLIP1 Fab before coincubation with sperm, showed a significant, dose-dependent decrease in sperm-egg plasma membrane binding. Similar results were obtained when affinity-purified antiSLIP1 IgG was used for egg pretreatment. The significance of egg SLIP1 in sperm-egg plasma membrane binding was further demonstrated by a decrease (36-52%) in in vitro fertilization when zona-intact eggs were pretreated with antiSLIP1 IgG. Since SLIP1 has been shown to bind SGG in vitro, we investigated the possibility that sperm SGG may participate in sperm-egg plasma membrane binding through egg SLIP1. Pretreatment of sperm with antiSGG Fab prior to coincubation with zona-free eggs resulted in a dose-dependent decrease in sperm-egg plasma membrane binding. Collectively, these findings strongly suggest a role for egg SLIP1 in sperm-egg plasma membrane interaction, which may be through its binding to sperm SGG.

Animals↗
PubMed1999

Variation in red cell transfusion practice in the intensive care unit: a multicentre cohort study.

OBJECTIVES: To determine the degree of interinstitutional transfusion practice variation and reasons why red cells are administered in critically ill patients. STUDY DESIGN: Multicentre cohort study combined with a cross-sectional survey of physicians requesting red cell transfusions for patients in the cohort. STUDY POPULATION: The cohort included 5298 consecutive patients admitted to six tertiary level intensive care units in addition to administering a survey to 223 physicians requesting red cell transfusions in these units. MEASUREMENTS: Haemoglobin concentrations were collected, along with the number and reasons for red cell transfusions plus demographic, diagnostic, disease severity (APACHE II score), intensive care unit (ICU) mortality and lengths of stay in the ICU. RESULTS: Twenty five per cent of the critically ill patients in the cohort study received red cell transfusions. The overall number of transfusions per patient-day in the ICU averaged 0.95 +/- 1.39 and ranged from 0.82 +/- 1.69 to 1.08 +/- 1.27 between institutions (P < 0.001). Independent predictors of transfusion thresholds (pre-transfusion haemoglobin concentrations) included patient age, admission APACHE II score and the institution (P < 0.0001). A very significant institution effect (P < 0.0001) persisted even after multivariate adjustments for age, APACHE II score and within four diagnostic categories (cardiovascular disease, respiratory failure, major surgery and trauma) (P < 0.0001). The evaluation of transfusion practice using the bedside survey documented that 35% (202 of 576) of pre-transfusion haemoglobin concentrations were in the range of 95-105 g/l and 80% of the orders were for two packed cell units. The most frequent reasons for administering red cells were acute bleeding (35%) and the augmentation of O2 delivery (25%). CONCLUSIONS: There is significant institutional variation in critical care transfusion practice, many intensivists adhering to a 100g/l threshold, and opting to administer multiple units despite published guidelines to the contrary. There is a need for prospective studies to define optimal practice in the critically ill.

Journal Article↗
PubMed1999

The Heart and Estrogen/Progestin Replacement Study: what have we learned and what questions remain?

The Heart and Estrogen/Progestin Replacement Study (HERS) was the first randomised, double-blind, placebo-controlled study to evaluate the outcome of hormone replacement therapy (HRT) on subsequent cardiac events in postmenopausal women with established coronary heart disease (CHD). Of the 2763 women enrolled, 1380 were randomised to receive 0.625mg of conjugated equine estrogens plus 2.5mg of medroxyprogesterone daily (Prempro) and 1383 were randomised to receive a placebo. The results were surprising: 179 women in the hormone group and 182 women in the placebo group experienced either a nonfatal myocardial infarction or CHD death (relative hazard 0.99, 95% confidence interval 0.81 to 1.22). This occurred despite a net 11% reduction in low density lipoprotein (LDL) and a net 10% increase in high density lipoprotein (HDL) after 1 year of follow-up (p < 0.001 for LDL and HDL). Also, there were no differences between the 2 treatment groups in any secondary cardiovascular outcomes. The overall null effect may have been the result of an unexpected early adverse effect of the HRT regimen that offset a later reduction in risk. Clearly, the use of HRT for secondary prevention of heart disease is more complex than was initially believed. More data are needed from other clinical trials concerning the risks and benefits of HRT to confirm or refute the puzzling HERS results. HERS also underscores the need for trials with clinical end-points to evaluate both the safety and efficacy of drug therapy. Although observational studies are useful, they cannot provide definitive answers regarding treatment recommendations. Until further data are available, clinicians should not use estrogen plus medroxyprogesterone for the sole purpose of secondary prevention of CHD.

Aged↗
PubMed1999

ACR and EULAR improvement criteria have comparable validity in rheumatoid arthritis trials. American College of Rheumatology European League of Associations for Rheumatology.

We compared the validity of the American College of Rheumatology (ACR) and the European League of Associations for Rheumatology (EULAR) definitions of response in rheumatoid arthritis (RA) clinical trials. US: ACR and EULAR improvement criteria were calculated in 7 large randomized RA clinical trials. The discriminant validity of the response criteria between treatment groups was studied using the Mantel-Haenszel chi-squared value. To compare both sets of criteria the chi-squared ratio was determined for each trial. Europe: In 2 large randomized RA clinical trials, ACR and EULAR criteria were calculated, once with extensive and once with 28 joint counts. The classification of patients with these 4 criteria were compared with each other using cross tables. We further studied the difference in response between treatment groups per trial, the association of response with patient and investigator assessment of improvement, and the association of response with radiological progression. US: The chi-squared ratio for most trials was close to 1. There was no clear pattern suggesting that the discriminant validity of the ACR criteria was stronger than the discriminant validity of the EULAR definition of response or vice versa. Europe: Conflicting results between ACR and EULAR were present in only 3% of patients in both trials. The discriminant validity of all 4 criteria (ACR and EULAR with reduced and extensive joint counts) was comparable. All criteria were related with the overall assessment of improvement by both investigator and patient. The association with radiographic progression was comparable for EULAR and ACR improvement criteria. There is a high level of agreement between ACR and EULAR improvement classification, and their validity is equivalent. The discriminating potential of the criteria between treatment groups is comparable, as is the association with patient's and investigator's overall assessment and with radiographic progression.

Antirheumatic Agents↗
PubMed1999

Validity of area-under-the-curve analysis to summarize effect in rheumatoid arthritis clinical trials.

There is a continuing interest in increasing the statistical efficiency of the analysis of clinically meaningful endpoints in rheumatology. One issue that is attracting increasing attention is whether the conventional practice of only reporting the outcome at the end of the study (EOS) might be replaced or complemented by a longitudinal summary that better reflects the clinical course of the disease. The area under the curve (AUC) is a summary measure that integrates serial assessments of a patient's endpoint over the duration of the study. We evaluated the utility of AUC as a summary measure for the analysis and reporting of two RA trials: (i) methotrexate combined with cyclosporine versus methotrexate and placebo in partial methotrexate responders in relatively late disease, and (ii) prednisone plus methotrexate plus sulfasalazine versus sulfasalazine alone in relatively early disease. We replicated the published results of each trial first using the conventional EOS and then AUC summaries. For each patient, the changes from baseline over time were transformed into a summary measure by calculating AUC using the trapezium rule and then standardizing it by the study duration. Using an approach similar to the index of responsiveness to change, we scaled treatment differences derived from EOS and AUC summary measures by their standard deviation of the control group. This signal-versus-noise ratio captures the treatment discrimination ability of each summary measure. Compared to EOS and within each treatment group, the AUC summary reported smaller effects (i.e., change from baseline) with reduced errors in the estimates. AUC measures preserved discriminant validity in treatment comparisons and reported smaller but more precise treatment effect estimates. In the COBRA trial with rapidly-acting medications, AUC seemed to be more sensitive than EOS to detect treatment difference. With slow acting medications and in relatively late disease patients as in the cyclosporine trial, EOS was more sensitive to detect treatment difference than was AUC. In this setting, AUC, however, still seemed to be more sensitive than EOS for the two responsive-to-change endpoints: tender joint counts and pain by visual analog scale. AUC integrates repeated assessments during the trial duration into summary measures. Compared to EOS, the report of RA trial results using AUC summary provides smaller estimates of treatment effects but with better precision. AUC summary is likely to preserve treatment group discrimination taking into account the appropriate onset and offset of the drug action. Trial reports using AUC summary have smaller effect sizes. For trials with long acting medications and short duration similar to the cyclosporine trial, AUC still preserves treatment discrimination but may not be as sensitive as EOS. The calculations of AUC require some additional work in the analysis of each endpoint.

Antirheumatic Agents↗
PubMed1999

A metaanalysis on the use of bisphosphonates in corticosteroid induced osteoporosis.

OBJECTIVE: To conduct a metaanalysis on the use of bisphosphonates in corticosteroid induced osteoporosis. METHODS: A Cochrane systematic review including electronic database searching (MEDLINE and EMBASE), and selected hand searching of reference lists and scientific abstracts was conducted. Metaanalysis using random and fixed effects modeling was used on the selected trials to calculate summary effect measures. All controlled clinical trials dealing with prevention or treatment of corticosteroid induced osteoporosis with bisphosphonates of any type and reporting the outcome of interest were assessed. Trials had to involve adults only, and subjects had to be taking a mean steroid dose of 7.5 mg/day or more. Outcomes of interest were change in bone mineral density (BMD) at the lumbar spine and femoral neck at 6 and 12 months. If present, data on number of new fractures and adverse effects were also extracted. The extraction was performed by 2 independent reviewers. RESULTS: Results are reported as a weighted mean difference in the percentage change in BMD between the treatment and placebo groups, with trials being weighted by the inverse of their variance. At the lumbar spine the weighted mean difference between the treatment and placebo groups was 4.0% (95% CI 2.5, 5.5). At the femoral neck the weighted mean difference was 2.1% (95% CI 0.2, 4.0). Although there was a 24% reduction in spinal fractures, this result did not reach statistical significance. CONCLUSION: Bisphosphonates are effective at preventing and treating corticosteroid induced bone loss at the lumbar spine. Efficacy regarding fracture prevention cannot be concluded from this analysis, although bone density changes are correlated with fracture risk. Bisphosphonates are less efficacious at preventing or treating corticosteroid induced osteoporosis at the femoral neck.

Adrenal Cortex Hormones↗
PubMed1999

Patient based methods for assessing adverse events in clinical trials in rheumatology. Progress report for the OMERACT Drug Toxicity Working Party. Outcome Measures in Rheumatology.

There has been increasing recognition in recent years that the measurement of drug related toxicities in rheumatology clinical trials has been sub-optimal. The OMERACT Drug Toxicity Working Party was established to address this issue. The first task of the working party was to identify a minimum set of attributes of drug related toxicity that would be important to patients, clinicians, investigators, and policymakers. The working party then developed consensus on a standard set of properties for instruments to measure these attributes. Existing instruments in the field of rheumatology were ascertained by literature review and by contact with experts in the field. Four instruments were ascertained and evaluated using the guidelines developed by the working party. This report outlines the progress and preliminary results of these activities.

Antirheumatic Agents↗
PubMed1999

The responsiveness of generic quality of life instruments in rheumatic diseases. A systematic review of randomized controlled trials.

To review the available evidence that has used generic instruments alone or in comparison with disease specific instruments. A systematic review was carried out using the methods recommended by the Cochrane Collaboration. We used MEDLINE and EMBASE searches and we performed a hand search of the abstracts listed under "quality of life" at American College of Rheumatology (ACR) meetings. Selection was limited to randomized controlled trials (RCT) using generic instruments in populations older than 18 years with any of the following diseases: rheumatoid arthritis, fibromyalgia, osteoporosis, osteoarthritis, systemic lupus erythematosus, and ankylosing spondylitis. Language was restricted to English papers. Studies using only disease-specific instruments were excluded. From 488 articles retrieved, 13 reports of 10 randomized controlled trials were selected. There were 101 abstracts on quality of life in ACR abstract books; 78 abstracts contained data on generic instruments, and of these, 9 described their use in RCT. Despite a substantial increase in the number of papers and abstracts addressing different aspects of generic questionnaires, the majority of the papers were descriptive. The evidence is not yet available to document that any of the generic instruments pass the requirements of the OMERACT Filter.

Adult↗
PubMed1999

Sensitivity to change of generic quality of life instruments in patients with rheumatoid arthritis: preliminary findings in the generic health OMERACT study. OMERACT/ILAR Task Force on Generic Quality of Life. Life Outcome Measures in Rheumatology. International League of Associations for Rheumatology.

This is the initial report of the generic health OMERACT study concerned with the sensitivity to change of generic quality of life (QOL) measures. Our objective was to determine which QOL instrument is best able to show a statistically significant improvement in patients with rheumatoid arthritis (RA) demonstrating relevant improvement in a core set of disease activity and disease-specific disability measures. A multicenter controlled trial of a single group with repeated measurements at 0 (baseline), 3, and 6 months was conducted. All participating centers recruited 10 patients with RA who were about to start methotrexate therapy for the first time because of active disease. Assessments included disease activity measures, disease-specific disability measures, and generic QOL measures. To date, 40 patients have been recruited from 4 centers for the study. After 6 months of treatment many of the generic QOL measures showed a 20% improvement from baseline and medium standardized response means around 0.5. In particular, the Nottingham Health Profile (NHP) and the Rheumatoid Arthritis Quality of Life (RAQOL) measures had the largest percentage improvement (22 and 29%, respectively) and standardized response means (both with 0.54). Early results on the sensitivity of generic health QOL measures are promising, in particular for the NHP and RAQOL measures.

Antirheumatic Agents↗
PubMed1999

Responsiveness of endpoints in osteoporosis clinical trials--an update.

As an update of our earlier paper, published as part of the Outcome Measures in Rheumatology Clinical Trials (OMERACT 3) proceedings in 1996, we surveyed the types of outcomes incorporated in recent clinical trials. A literature search was conducted on MEDLINE and Current Contents, from January 1996 to March 1998, using the search strategy recommended by the Cochrane Collaboration for the identification of randomized controlled trials (RCT). Two independent reviewers selected trials according to inclusion criteria. The same reviewers extracted data on clinical and radiographic fractures, pain, quality of life, and bone mineral density (BMD). Seventy-four RCT conducted on bone loss in postmenopausal women were identified. Most trials incorporated biochemical markers and BMD as outcome measures. Fewer trials included vertebral fractures, pain, height, and quality of life. The responsiveness is presented in terms of the sample size needed per group to show a statistically significant difference. The most responsive outcomes were pain, BMD, and biochemical markers. The number needed to treat to prevent one vertebral fracture ranged from 13 to 54, depending on the intervention and population. Investigators should examine the characteristics of the patient population and the nature of the intervention in determining the sample size required to demonstrate a significant effect. The selection of endpoints should be based on their responsiveness, feasibility, and the importance of using standardized outcomes. Standardized outcomes greatly facilitate the synthesis of available information into systematic reviews by groups such as the Cochrane Collaboration.

Antirheumatic Agents↗