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B Shea

Publications and source records attributed to B Shea.

At least 73 records · Page 4Linked to original sources
PubMed2000

Low level laser therapy (classes I, II and III) in the treatment of rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) affects a large proportion of the population. Low Level Laser Therapy (LLLT) was introduced as an alternative non-invasive treatment for RA about 10 years ago. LLLT is a light source that generates extremely pure light, of a single wavelength. The effect is not thermal, but rather related to photochemical reactions in the cells. The effectiveness of LLLT for rheumatoid arthritis is still controversial. OBJECTIVES: To assess the effectiveness of LLLT in the treatment of RA. SEARCH STRATEGY: We searched MEDLINE, EMBASE, the registries of the Cochrane Musculoskeletal group and the field of Rehabilitation and Related Therapies as well as the Cochrane Controlled Trials Register up to January 30, 2000. SELECTION CRITERIA: Following an a priori protocol, we selected only randomized controlled trials of LLLT for the treatment of patients with a clinical diagnosis of RA were eligible. Abstracts were excluded unless further data could be obtained from the authors. DATA COLLECTION AND ANALYSIS: Two reviewers independently select trials for inclusion, then extracted data and assessed quality using predetermined forms. Heterogeneity was tested with Cochran's Q test. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results were analyzed as weighted mean differences (WMD) with 95% confidence intervals (CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD) were calculated by dividing the difference between treated and control by the baseline variance. SMD were used when different scales were used to measure the same concept (e.g. pain). Dichotomous outcomes were analyzed with odds ratios. MAIN RESULTS: A total of 204 patients were included in the five placebo-controlled trials, with 112 randomized to laser therapy. Relative to a separate control group, LLLT reduced pain by 70% relative to placebo and reduced morning stiffness duration by 27.5 minutes (95%CI: 2.9 to 52 minutes) and increased tip to palm flexibility by 1.3 cm (95% CI: 0. 8 to 1.7 cm). Other outcomes such as functional assessment, range of motion and local swelling did not differ between groups. There were no significant differences between subgroups based on LLLT dosage, wavelength, site of application or treatment length. For RA, relative to a control group using the opposite hand, there was no difference between the control and treatment hand, but all hands improved in terms of pain relief and disease activity. REVIEWER'S CONCLUSIONS: In summary, LLLT for RA is beneficial as a minimum of a four-week treatment with reductions in pain and morning stiffness. On the one hand, this meta-analysis found that pooled data gave some evidence of a clinical effect, but the outcomes were in conflict, and it must therefore be concluded that firm documentation of the application of LLLT in RA is not possible. Clinicians and researchers should consistently report the characteristics of the LLLT device and the application techniques used. New trials on LLLT should make use of standardized, validated outcomes. Despite some positive findings, this meta-analysis lacked data on how LLLT effectiveness is affected by four important factors: wavelength, treatment duration of LLLT, dosage and site of application over nerves instead of joints.

Arthritis, Rheumatoid↗
PubMed2000

Transcutaneous electrical nerve stimulation for knee osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is a disease that affects synovial joints, which mainly causes degeneration and destruction of hyaline cartilage. To date, no curative treatment for OA exists. The primary goals for OA therapy are to relieve pain, maintain or improve functional status, and minimize deformity. Transcutaneous electrical nerve stimulation (TENS) is a noninvasive modality in physiotherapy that is commonly used to control both acute and chronic pain arising from several conditions. A number of trials evaluating the efficacy of TENS in OA have been published. OBJECTIVES: To assess the effectiveness of TENS in the treatment of knee OA. The primary outcomes of interest were those described by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) 3, which included pain relief, functional status, patient global assessment, and change in joint imaging for studies of one year or longer. The secondary objective was to determine the most effective mode of TENS application in pain control. SEARCH STRATEGY: We searched MEDLINE, EMBASE, CINAHL, HEALTHSTAR, PEDro, Current Contents and the Cochrane Controlled Trial Register using the Cochrane Musculoskeletal Group search strategy for trials up to and including December 1999. We also hand-searched reference lists and consulted content experts. SELECTION CRITERIA: Two independent reviewers selected the trials that met predetermined inclusion criteria. DATA COLLECTION AND ANALYSIS: Two independent reviewers extracted the data using standardized forms and assessed the quality of randomization, blinding and dropouts. A third reviewer was consulted to resolve any differences. For dichotomous outcomes, relative risks (RR) were calculated. For continuous data, weighted mean differences (WMD) or standardized mean difference (SMD) of the change from baseline were calculated. A fixed effects model was used unless heterogeneity of the populations existed. In this case, a random effects model was used. MAIN RESULTS: Seven trials were eligible to be included in this review. Six used TENS as the active treatment while one study used acupuncture-like TENS (AL-TENS). A number of 148 and 146 patients were involved in the active TENS treatment and placebo, respectively. Three studies were cross-over studies and the others were parallel group, randomized controlled trials (RCTs). Median methodological quality of these studies was two. Pain relief from active TENS and AL-TENS treatment was significantly better than placebo treatment. Knee stiffness also improved significantly in active treatment group compared to placebo. Different modes of TENS setting (High Rate and Strong Burst Mode TENS) demonstrated a significant benefit in pain relief of the knee OA over placebo. Subgroup analyses showed a heterogeneity in the studies with methodological quality of three or more and those with repeated TENS applications. REVIEWER'S CONCLUSIONS: TENS and AL-TENS are shown to be effective in pain control over placebo in this review. Heterogeneity of the included studies was observed, which might be due to the different study designs and outcomes used. More well designed studies with a standardized protocol and adequate number of participants are needed to conclude the effectiveness of TENS in the treatment of OA of the knee.

Humans↗
PubMed2000

Fluoride for treating postmenopausal osteoporosis.

OBJECTIVES: To assess the efficacy of fluoride therapy on bone loss, vertebral and non-vertebral fractures and side effects in postmenopausal women. SEARCH STRATEGY: We searched Medline, Current Contents and the Cochrane Controlled Trial Registry up to December 1998. SELECTION CRITERIA: Two independent reviewers selected RCTs which met predetermined inclusion criteria. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data using predetermined forms and assessed the methodological quality of the trials using a validated scale. For dichotomous outcomes, relative risks (RR) were calculated and for continuous outcomes, weighted mean differences (WMD) of percentage change from baseline were calculated. Where heterogeneity existed (determined by a chi-square test) a random effects model was used. MAIN RESULTS: Eleven studies (1429 subjects) met the inclusion criteria. The increase in lumbar spine bone mineral density (BMD) was found to be higher in the treatment group than in the control group with a WMD 8.1% (95%CI: 7.15,9.09) after two years of treatment and 16.1%(95%CI: 14.65,17.5) after four years. The RR for new vertebral fractures was not significant at two years [0.87 (95%CI: 0.51,1.46)] or at four years [0.9(95%CI: 0.71,1.14)]. The RR for new non-vertebral fractures was not significant at two years 1.2(95%CI: 0.68,2.1) but was increased at four years in the treated group 1.85(95%CI: 1.36,2.5), especially if used at high doses and in a non slow release form. The RR for gastrointestinal side effects was not significant at two years 2.18(95%CI: 0.86,1.21) but was increased at four years in the treated group 2.18(95%CI: 1.69,4.57) especially if fluoride was used at high doses and in a non slow release form. The number of withdrawals and dropouts was not different between treated and control groups at two and four years. REVIEWER'S CONCLUSIONS: Although fluoride has an ability to increase BMD at lumbar spine, it does not result in a reduction of vertebral fractures. In increasing the dose of fluoride, one increases the risk of non-vertebral fracture and gastrointestinal side effects without any effect on the vertebral fracture rate.

Bone Density↗
PubMed2000

Thermotherapy for treating rheumatoid arthritis.

BACKGROUND: Heat and cold therapy are often used as adjuncts in the treatment of rheumatoid arthritis by rehabilitation specialists. OBJECTIVES: To evaluate the effects of heat and cold on objective and subjective measures of disease activity in patients with rheumatoid arthritis. SEARCH STRATEGY: We searched Medline, Embase, PEDro, Current Contents, Sports Discus and CINAHL up to June 2000. The Cochrane Field of Rehabilitation and related therapies and the Cochrane Musculoskeletal Review Group were also contacted for a search of their specialized registers. Handsearching was conducted on all retrieved articles for additional articles. SELECTION CRITERIA: Randomized or controlled clinical trials of ice or heat compared to placebo or active interventions in patients with rheumatoid arthritis and case-control and cohort studies were eligible. No language restrictions were applied. Abstracts were accepted. DATA COLLECTION AND ANALYSIS: Two independent reviewers identified potential articles from the literature search. These reviewers extracted data using pre-defined extraction forms. Consensus was reached on all data extraction. Quality was assessed by two reviewers using a 5 point scale that measured the quality of randomization, double-blinding and description of withdrawals. MAIN RESULTS: Three studies (79 subjects) met the inclusion criteria. There was no effect on objective measures of disease activity (including inflammation, pain and x-ray measured joint destruction) of either ice versus control or heat versus control. Patients reported that they preferred heat therapy to no therapy (94% like heat therapy better than no therapy). There was no difference in patient preference for heat or ice. No harmful effects of ice or heat were reported. REVIEWER'S CONCLUSIONS: Since patients enjoy thermotherapy, and there are no harmful effects, thermotherapy should be recommended as a therapy which can be applied at home as needed to relieve pain. There is no need for further research on the effects of heat or cold for RA.

Arthritis, Rheumatoid↗
PubMed2000

Fluoride for the treatment of postmenopausal osteoporotic fractures: a meta-analysis.

We conducted an effectiveness meta-analysis to determine the efficacy of fluoride therapy on bone loss, vertebral and nonvertebral fractures and side effects in postmenopausal women. A literature search was conducted on MEDLINE, Current Contents and the Cochrane Controlled Trial Registry. Two independent reviewers selected randomized controlled trials which met predetermined inclusion criteria. They independently extracted data using predetermined forms and assessed the methodologic quality of the trials using a validated scale. For dichotomous outcomes, the relative risk (RR) was calculated, and for continuous outcomes, the weighted mean difference (WMD) of percentage change from baseline was calculated. Where heterogeneity existed (determined by a chi-square test) a random effects model was used. Eleven studies (1429 subjects) met the inclusion criteria. The increase in lumbar spine bone mineral density (BMD) was found to be higher in the treatment group than in the control group with a WMD 8.1% (95% CI: 7.15, 9.09) after 2 years of treatment and 16.1% (95% CI: 14.65, 17.5) after 4 years. The RR for new vertebral fractures was not significant at 2 years [0.87 (95% CI: 0.51, 1.46)] or at 4 years [0.9 (95% CI: 0.71, 1.14)]. The RR for new nonvertebral fractures was not significant at 2 years [1.2 (95% CI: 0.68, 2.10)] but was increased at 4 years in the treated group [1.85 (95% CI: 1.36, 2.50)], especially if used at high doses and in a non-slow-release form. The RR for gastrointestinal side effects was not significant at 2 years [2.18 (95% CI: 0.86, 1.21)] but was increased at 4 years in the treated group [2.18 (95% CI: 1.69, 4.57)], especially if fluoride was used at high doses and in a non-slow-release form. The number of withdrawals and dropouts was not different between treated and control groups at 2 and 4 years. Thus, although fluoride has an ability to increase bone mineral density at the lumbar spine, it does not result in a reduction in vertebral fractures. Increasing the dose of fluoride increases the risk of nonvertebral fractures and gastrointestinal side effects without any effect on the vertebral fracture rate.

Aged↗
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↗
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

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↗
PubMed1998

Effect of computerized physician order entry and a team intervention on prevention of serious medication errors.

CONTEXT: Adverse drug events (ADEs) are a significant and costly cause of injury during hospitalization. OBJECTIVES: To evaluate the efficacy of 2 interventions for preventing nonintercepted serious medication errors, defined as those that either resulted in or had potential to result in an ADE and were not intercepted before reaching the patient. DESIGN: Before-after comparison between phase 1 (baseline) and phase 2 (after intervention was implemented) and, within phase 2, a randomized comparison between physician computer order entry (POE) and the combination of POE plus a team intervention. SETTING: Large tertiary care hospital. PARTICIPANTS: For the comparison of phase 1 and 2, all patients admitted to a stratified random sample of 6 medical and surgical units in a tertiary care hospital over a 6-month period, and for the randomized comparison during phase 2, all patients admitted to the same units and 2 randomly selected additional units over a subsequent 9-month period. INTERVENTIONS: A physician computer order entry system (POE) for all units and a team-based intervention that included changing the role of pharmacists, implemented for half the units. MAIN OUTCOME MEASURE: Nonintercepted serious medication errors. RESULTS: Comparing identical units between phases 1 and 2, nonintercepted serious medication errors decreased 55%, from 10.7 events per 1000 patient-days to 4.86 events per 1000 (P=.01). The decline occurred for all stages of the medication-use process. Preventable ADEs declined 17% from 4.69 to 3.88 (P=.37), while nonintercepted potential ADEs declined 84% from 5.99 to 0.98 per 1000 patient-days (P=.002). When POE-only was compared with the POE plus team intervention combined, the team intervention conferred no additional benefit over POE. CONCLUSIONS: Physician computer order entry decreased the rate of nonintercepted serious medication errors by more than half, although this decrease was larger for potential ADEs than for errors that actually resulted in an ADE.

Clinical Pharmacy Information Systems↗
PubMed1998

Test-treatment strategies for patients suspected of having Lyme disease: a cost-effectiveness analysis.

PURPOSE: To examine the cost-effectiveness of test-treatment strategies for patients suspected of having Lyme disease. DATA SOURCES: The medical literature was searched for information on outcomes and costs. Expert opinion was sought for information on utilities. STUDY SELECTION: Articles that described patient population, diagnostic criteria, dose and duration of therapy, and criteria for assessment of outcomes. DATA EXTRACTION: The decision analysis evaluated the following strategies: 1) no testing-no treatment; 2) testing with enzyme-linked immunosorbent assay (ELISA) followed by antibiotic treatment of patients with positive results; 3) two-step testing with ELISA followed by Western blot and antibiotic treatment for patients with positive results on either test; and 4) empirical antibiotic therapy. Three patient scenarios were considered: myalgic symptoms, rash resembling erythema migrans, and recurrent oligoarticular inflammatory arthritis. Results were calculated as costs per quality-adjusted life-year and were subjected to sensitivity analysis. Adjustment was made for the diagnostic value of common clinical features of Lyme disease. DATA SYNTHESIS: For myalgic symptoms without other features suggestive of Lyme disease, the no testing-no treatment strategy was most economically attractive (that is, had the most favorable cost-effectiveness ratio). For rash, empirical antibiotic therapy was less costly and more effective than other strategies. For oligoarticular arthritis with a history of rash and tick bite, two-step testing was associated with the lowest cost-effectiveness ratio. Testing with ELISA and empirical antibiotic therapy cost an additional $880,000 and $34,000 per quality-adjusted life-year, respectively. For oligoarticular arthritis with one or no other features suggestive of Lyme disease, two-step testing was most economically attractive. CONCLUSIONS: Neither testing nor antibiotic treatment is cost-effective if the pretest probability of Lyme disease is low. Empirical antibiotic therapy is recommended if the pretest probability is high, and two-step testing is recommended if the pretest probability is intermediate.

Anti-Bacterial Agents↗
PubMed1998

Effects of following National Committee for Clinical Laboratory Standards and Deutsche Industrie Norm-Medizinische Mikrobiologie guidelines, country of isolate origin, and site of infection on susceptibility of Escherichia coli to amoxicillin-clavulanate (Augmentin).

Amoxicillin-clavulanate (Augmentin), as a combination of two active agents, poses extra challenges over single agents in establishing clinically relevant breakpoints for in vitro susceptibility tests. Hence, reported differences in amoxicillin-clavulanate percent susceptibilities among Escherichia coli isolates may reflect localized resistance problems and/or methodological differences in susceptibility testing and breakpoint criteria. The objectives of the present study were to determine the effects of (i) methodology, e.g., those of the National Committee for Clinical Laboratory Standards (NCCLS) and the Deutsche Industrie Norm-Medizinische Mikrobiologie (DIN), (ii) country of origin (Spain, France, and Germany), and (iii) site of infection (urinary tract, intra-abdominal sepsis, or other site[s]) upon the incidence of susceptibility to amoxicillin-clavulanate in 185 clinical isolates of E. coli. Cefuroxime and cefotaxime were included for comparison. The use of NCCLS methodology resulted in different distribution of amoxicillin-clavulanate MICs than that obtained with the DIN methodology, a difference highlighted by the 10% more strains found to be within the 8- to 32-microg/ml MIC range. This difference reflects the differing amounts of clavulanic acid present. NCCLS and DIN methodologies also produce different MIC distributions for cefotaxime but not for cefuroxime. Implementation of NCCLS and DIN breakpoints produced markedly different incidences of strains that were found to be susceptible, intermediate or resistant to amoxicillin-clavulanate. A total of 86.5% strains were found to be susceptible to amoxicillin-clavulanate by the NCCLS methodology, whereas only 43.8% were found to be susceptible by the DIN methodology. Similarly, 4.3% of the strains were found to be resistant by NCCLS guidelines compared to 21.1% by the DIN guidelines. The use of DIN breakpoints resulted in a fivefold-higher incidence of strains categorized as resistant to cefuroxime. There were no marked differences due to country of origin upon the MIC distributions for amoxicillin-clavulanate, cefuroxime, or cefotaxime, as determined with the NCCLS guidelines. Isolates from urinary tract and intra-abdominal infections were generally more resistant to amoxicillin-clavulanate than were isolates from other sites of infection.

Amoxicillin-Potassium Clavulanate Combination↗
PubMed1998

The efficacy of folic acid and folinic acid in reducing methotrexate gastrointestinal toxicity in rheumatoid arthritis. A metaanalysis of randomized controlled trials.

OBJECTIVE: To assess the efficacy of folic acid and folinic acid in reducing the mucosal and gastrointestinal (GI) side effects of low dose methotrexate (MTX) in patients with rheumatoid arthritis (RA). METHODS: A systematic review was carried out using the methods recommended by the Cochrane Collaboration. We used MEDLINE and performed hand searches that included bibliographic references, Current Contents, abstracts of rheumatology meetings, and 4 rheumatology journals to select double blind randomized controlled trials (RCT) in which adult patients with RA were treated with low doses of MTX (< 20 mg/week), concurrently with folic or folinic acid. The quality of the RCT was assessed. The overall treatment effect across trials (reduction in toxicity) was estimated using a fixed effects model. Disease activity was evaluated using standardized mean differences to ensure comparability across outcome measures. Sensitivity analyses were conducted evaluating different doses and the quality of the trials. Costs per month in different countries were compared. RESULTS: Of 11 trials retrieved, 7 met inclusion criteria. The total sample included 307 patients, of which 147 were treated with folate supplementation, 67 patients with folic, and 80 with folinic acid. A 79% reduction in mucosal and GI side effects was observed for folic acid [OR = 0.21 (95% CI 0.10 to 0.44)]. For folinic acid, a clinically but nonstatistically significant reduction of 42% was found [OR = 0.58 (95% CI 0.29 to 1.16)]. No major differences were observed between low and high doses of folic or folinic acid. Hematologic side effects could not be analyzed, since details by patients of each event were not provided. No consistent differences in disease activity variables were observed when comparing placebo and folic acid or folinic acid at low doses; patients receiving high dose folinic acid had increased tender and swollen joint counts. Substantial differences in costs across countries were found; folinic acid was more expensive. CONCLUSION: Our results support the protective effect of folate supplementation in reducing MTX side effects related to the oral and GI systems.

Adult↗
PubMed1997

Laboratory evaluation in the diagnosis of Lyme disease.

PURPOSE: To provide a qualitative evaluation of the predictive value of the laboratory diagnosis of Lyme disease and to use the resultant data to formulate guidelines for clinical diagnosis. DATA SOURCES: A MEDLINE search of English-language articles or articles with English-language abstracts published from 1982 to 1996. DATA EXTRACTION: Sensitivity, specificity, and likelihood ratios were calculated, and a random-effects model was used to combine the proportions from the eligible studies. Prespecified criteria were used to determine which studies were eligible for analysis. DATA SYNTHESIS: Laboratory testing in general is not clinically useful if the pretest probability of Lyme disease is less than 0.20 or greater than 0.80. When the pretest probability is 0.20 to 0.80, sequential testing with enzyme-linked immunosorbent assay and Western blot is the most accurate method for ruling in or ruling out the possibility of Lyme disease. CONCLUSIONS: Laboratory testing is recommended only in patients whose pretest probability of Lyme disease is 0.20 to 0.80. If the pretest probability is less than 0.20, testing will result in more false-positive results than true-positive results; a negative test result in this situation effectively rules out the disease.

Bacteriological Techniques↗
PubMed1997

Implications of OMERACT outcomes in arthritis and osteoporosis for cochrane metaanalysis.

The Cochrane Collaboration has established a set of methods for pooling multiple studies assessing the same intervention. Assessing the same endpoints in all studies is important to allow different trials to be combined using metaanalysis. OMERACT can play a key role in establishing consensus on the use of common endpoints that are credible to clinicians. We describe the data that need to be included in individual trial reports for metaanalyses to be carried out.

Arthritis↗