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Weighted Mean Difference

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123681. Helicobacter pylori eradication is superior to ulcer healing with or without maintenance therapy to prevent further ulcer haemorrhage

that relevant publications have been missed. The validity of the individual trials was not assessed or taken account of in the analysis; this means that the results of any poorer quality studies were given the same weight as good quality studies. Implications of the review for practice and research Practice: The authors state that all patients with ulcer bleeding should be tested for H. pylori infection and appropriately treated if positive. Research: The authors did not state any implications for further (...) treatment arm, were calculated. The relative risk reduction (RRR), the absolute risk reduction (ARR), and the numbers-needed-to-treat (NNT) to prevent one episode of recurrent bleeding, were also calculated for the individual trials and for the pooled data. How were differences between studies investigated? The homogeneity of the trials was investigated prior to pooling for the meta-analysis using the Breslow-Day method (see Other Publications of Related Interest). Results of the review Ten RCTs were

2001 DARE.

123682. Gabapentin for neuropathic pain: systematic review of controlled and uncontrolled literature

by the total number of patients who received gabapentin. In controlled studies where the continuous and dichotomous outcomes were clinically and statistically homogeneous, the data were pooled. A fixed-effect model was used to calculate the relative benefit and 95% confidence intervals (CIs) for dichotomous outcomes, and the weighted mean difference and 95% CIs for continuous outcomes. When the data were clinically homogeneous, but statistically heterogeneous, the data were pooled using a random-effects (...) controlled trials found 2 high-quality and 2 low-quality placebo-controlled randomised controlled trials. Of the 2 active-controlled trials, one was high quality and one was low quality. In the placebo-controlled trials (n=4), the number of patients reporting moderate or excellent pain relief showed statistical homogeneity (chi-squared 7.06, d.f.=3) and resulted in a relative benefit of 2.5 (95% CI: 1.9, 3.4). The visual analog scale (VAS) results (n=2) gave a weighted VAS mean difference of -11.1 mm (95

2001 DARE.

123683. Are fluid-based cytologies superior to the conventional Papanicolaou test: a systematic review

, blood, thick tests, scant cellularity, or air-drying artifact), or unsatisfactory. The rate difference between the two tests was calculated for satisfactory and for unsatisfactory specimens. Methods of synthesis How were the studies combined? Summary estimates of sensitivity and specificity were made using the random-effects model of DerSimonian and Laird, weighted by the inverse of the variance. The area under the receiver operating characteristic (ROC) curve was calculated for the FBC and Pap (...) independently reviewed the titles and abstracts, and studies were retrieved on the opinion of either reviewer. They then independently reviewed the retrieved articles, with any differences resolved by consensus with a third author. Assessment of study quality The authors developed a validity assessment that was systematically applied. The studies were scored out of 13, but details of the items scored were not supplied. Two reviewers independently assessed the validity of the included studies, with any

2001 DARE.

123684. Naltrexone, a relapse prevention maintenance treatment of alcohol dependence: a meta-analysis of randomized controlled trials

, the analysis included all patients randomised to treatment who received at least one dose of the assigned treatment. Methods of synthesis How were the studies combined? The pooled risk difference (RD) and pooled relative risk (RR) were calculated for the main outcomes, along with 95% confidence intervals (CIs), using fixed-effect (Mantel-Haenszel) and random-effects (DerSimonian and Laird) models. The weighted mean differences (WMDs) and 95% CIs were calculated for continuous variables using both a fixed (...) investigators in the field were contacted. Studies reported only as conference proceedings were excluded. Where multiple reports of the same study were identified, the report providing the greatest detail was included. Study selection Study designs of evaluations included in the review Randomised controlled trials (RCTs) of at least 3 months' duration were eligible if the studies had complete databases. To be included in the meta-analysis, the standard deviations of the means had to be either reported

2001 DARE.

123685. Dietary fiber for constipation in older adults: a systematic review

before-and-after study): the 2 studies reported contradictory results. Diarrhoea (2 RCTs with strong validity): one RCT reported no difference between treatment groups, while the other reported higher diarrhoea rates in the treatment compared to the control group. Amount of stool (1 RCT): the RCT reported a higher group mean stool weight in the treatment group (62 g/day) than in the control group (29 g/day). Authors' conclusions There is no strong or consistent evidence for the effectiveness (...) to modifying variables such as mobility, cognitive function, access to commodes, and fluid intake; and the use of different sources of dietary fibre. Stool frequency (5 studies: 4 RCTs and 1 blinded before-and-after study): the results were inconsistent with values for the difference between the treatment and control groups ranging from -1.5 to 1.3 mean stools per patient per week. The 2 RCTs with higher validity reported contradictory results. Pharmaceutical agent use (6 studies: 5 RCTs and 1 blinded

2001 DARE.

123686. Systematic review of patient and nurse attitudes to depot antipsychotic medication

of treatment. Five out of 6 studies (n=547) found that the majority of participants preferred to receive their medication via depot administration, rather than in tablet form. Two studies reported side-effects data. The top five side-effects were sleepiness, increased fatigability, weight gain, tension or inner unrest, and concentration difficulties. There were minimal data for nurse satisfaction with depot antipsychotics. However, some difference was found between the attitude of community psychiatric (...) reviewer checked a random 10% of the references. Any differences between the reviewers were resolved by discussion. Assessment of study quality Two stages of quality assessment were performed. The authors applied a combination of two hierarchies of evidence (NHS Centre for Reviews and Dissemination, and Greenhalgh) to grade the studies: RCTs, through non-randomised controlled trials, to cohort studies, to case-control studies, to case series, and so on (see Other Publications of Related Interest nos. 1

2001 DARE.

123687. A rapid and systematic review of the clinical effectiveness and cost-effectiveness of orlistat in the management of obesity

pooled statistically. A random-effects model was used to calculate a weighted mean difference for continuous data, and a relative risk for dichotomous data, along with the associated 95% confidence intervals (CIs). All statistical manipulations were conducted using Metaview software (version 4.1). No method of assessing publication bias was reported. How were differences between studies investigated? The heterogeneity of each statistical pooling was assessed using the chi-squared test, where a p (...) excluded for having a duration of less than one year. Two economic evaluations, one of which was submitted by the manufacturer, were included in the cost-effectiveness evaluation. Most of the trials showed greater weight loss and better weight maintenance with orlistat, compared with placebo, at all end points; the differences for both outcomes were statistically significant. Orlistat administered at a dose of 120 mg t.d.s. was the optimum regimen in terms of weight loss. Most trials showed significant

2001 DARE.

123688. Timing of initial administration of low-molecular-wight heparin prophylaxis against deep vein thrombosis in patients following elective hip arthroplasty: a systematic review

arthroplasty: a systematic review Hull R D, Pineo G F, Stein P D, Mah A F, MacIsaac S M, Dahl O E, Ghali W A, Butcher M S, Brant R F, Bergqvist D, Hamulyak K, Francis C W, Marder V J, Raskob G E Authors' objectives To perform a systematic review of the literature to assess the efficacy and safety of once-daily subcutaneous low molecular weight heparin (LMWH) administered at different times in relation to surgery, compared with oral anticoagulation prophylaxis. Searching Potential studies were identified (...) -operative 5 to 10 mg and usual dose INR 2-3); nadroparin (once-daily pre-operative 3,075 IU, post-operative and usual dose given according to body weight); acenocoumarol (4 mg pre-operative, 2 mg post-operative and INR 2-3 usual dose); dalteparin (pre-operative 2,500 IU, post-operative 2,500 IU, usual dose 5,000 IU; or post-operative only 2,500 IU and usual dose 5,000 IU). The timing for pre-operative medication varied from the day before surgery, to less than 2 hours before surgery. For post-operative

2001 DARE.

123689. Healing and relapse rates in gastroesophageal reflux disease treated with the newer proton-pump inhibitors lansoprazole, rabeprazole, and pantoprazole compared with omeprazole, ranitidine and placebo: evidence from randomized clinical trials

). Participants included in the review Studies of patients with an endoscopically confirmed diagnosis of GERD were included in the review. In practice, all of the studies focused on an adult population; the age ranged from 40 to 62 years (mean 52; standard deviation 5.3) for studies of acute therapy and from 44 to 61 years (where reported) for maintenance therapy. Thirty-nine per cent of the studies included women, and 81% required the presence of active disease. In relation to the maintenance phase, all (...) across studies by time point (4 and 8 weeks), with individual trial results being weighted by the inverse of the variance of the RR for each trial. The overall RR was then estimated by dividing the weighted average healing rates or heartburn relief rates for the treatments being compared with the estimates for omeprazole and ranitidine. These RRs were assessed using the Mantel-Haenszel chi-squared test, and 95% CIs were calculated using the exact method (see Other Publications of Related Interest

2001 DARE.

123690. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials

? The studies were grouped by treatment comparisons (exercise versus no exercise, and exercise plus diet versus no exercise plus no diet) and analysed separately. A pooled weighted mean difference (WMD) and 95% confidence intervals (CIs) were calculated with weighting by the inverse of the variance for HbA1c and body mass. A fixed-effect model was used. Publication bias was assessed using a funnel plot. How were differences between studies investigated? Statistical heterogeneity was assessed using the chi (...) two to six times a week, with each session lasting between 30 and 90 minutes; the programmes lasted from 8 to 52 weeks. Participants included in the review Studies of adults with type 2 diabetes were eligible for inclusion. The included studies were of patients of different ethnicities. The mean age of the participants (where reported) was 55 years, the mean duration of diabetes was 4.3 years, and 50% of the participants were women. Studies included patients who were already taking insulin

2001 DARE.

123691. Magnetic resonance angiography for the evaluation of lower extremity arterial disease: a meta-analysis

) were calculated for the different MRA techniques. How were differences between studies investigated? Homogeneity of the studies was tested using the Breslow-Day test for homogeneity of odds ratios A multiple regression analysis was performed to investigate differences between the studies. The studies were weighted according to the reciprocal of the variance of the log DOR. The variables investigated were year of publication, all methodological (study quality) criteria, reference standard (...) , the mean age of the included patients ranged from 53 to 74 years. Studies on MRA for follow-up after percutaneous transluminal angioplasty or surgery were excluded. Outcomes assessed in the review Studies that presented 2x2 contingency tables or data allowing their construction were eligible for inclusion. Studies were also included if these data were available for only a subset of patients. The outcome measures used in the review were sensitivity, specificity and the diagnostic odds ratio (DOR). How

2001 DARE.

123692. Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: a meta-analysis

weighted regression. How were differences between studies investigated? The authors performed formal tests of heterogeneity. They did not report the exact tests used. Results of the review Eight randomised controlled trials with 1,144 participants (range: 48 to 257 per trial) were included. Five of these trials were double-blind and placebo-controlled. Three included untreated controls. Quality assessment. On a scale of 0 to 5, the mean quality score of papers included in the review was 3.4 (standard (...) deviation 0.5, range: 3 to 4). There was no significant heterogeneity in the overall effects of treatment on any of the primary outcomes, so the authors included all 8 trials in their meta-analysis (test statistic and P-value not reported). There was some heterogeneity in the summary risk statistics reported, so the authors used ORs to describe the findings. Febrile neutropenia. The overall mean risk of febrile neutropenia was 32% for people receiving CSFs and 51% for controls (absolute risk difference

2002 DARE.

123693. A quantitative, systematic review of randomized controlled trials of ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for Cesarean delivery

and dichotomous outcomes were combined using a random-effects model (DerSimonian and Laird). The relative risks (RRs) and 95% confidence intervals (CIs) were calculated for dichotomous data, while the weighted mean differences (WMDs) were calculated for continuous data. How were differences between studies investigated? Heterogeneity was investigated using the Q statistic. Where significant heterogeneity existed (p<0.1) the studies were not pooled. No sensitivity analyses were performed due to the small (...) number of trials. Results of the review Seven studies (n=292) were included in the review. The studies were considered to be of a good quality, with all being double-blind. There was no difference between the treatments for the management, prevention and treatment of hypotension (7 trials; RR 1.00, 95% CI: 0.96, 1.06), the treatment of hypotension (4 trials; RR 1.00, 95% CI: 0.95, 1.05), or the risk of hypotension (3 trials; RR 1.09, 95% CI: 0.71, 1.69). There was no difference in the risk

2002 DARE.

123694. Reaching those most in need: a review of diabetes self-management interventions in disadvantaged populations

-literate African Americans, type 2 Mexican Americans, Canadian Aboriginal adults with or at risk of type 2, type 2 older adults, Zuni Indians, obese Pima Indians who were normoglycaemic, and type 2 veterans. The mean ages ranged from 34 to 68 years and the majority of the participants were female. Outcomes assessed in the review The key outcomes assessed in the review were: physiological, including weight, body composition, body mass index, waist circumference, cholesterol or lipids, blood-pressure (...) or providers willing to deliver the intervention or participate in the study, or the representativeness of these. Only one of the 10 studies reported information on whether the intervention was delivered as intended (over the phone via a nurse educator). Five studies reported participant adherence through session attendance, which ranged from 10 to 90% (median 60%). Maintenance. Four of the 10 studies reported on individual maintenance, and of these, 3 found no significant difference in long-term weight

2002 DARE.

123695. Lactobacillus therapy for acute infectious diarrhea in children: a meta-analysis

, to obtain a pooled weighted difference in the mean duration and mean number of stools on day 2. Publication bias was investigated using an adjusted rank correlation test (Begg and Mazumdar) and a regression asymmetry test (Egger et al.). How were differences between studies investigated? Subgroup analyses were predefined for age, use of additional therapy (oral rehydration or intravenous fluid), strain of Lactobacillus, dose and duration of Lactobacillus treatment, location of population, whether (...) reviewers independently assessed the methodology of the primary studies, resolving any disagreements by discussion. Data extraction The data were extracted independently by two reviewers and verified by a third. Data that best approximated duration, frequency and amount of diarrhoea were extracted from each study. Duration was converted into days. Methods of synthesis How were the studies combined? The studies were combined using a random-effects meta-analysis, weighted by the inverse of the variance

2002 DARE.

123696. Milk thistle: effects on liver disease and cirrhosis and clinical adverse effects

. The data included study design, type of event, and criteria for evaluating causality in drug adverse effects. Methods of synthesis How were the studies combined? The studies were synthesised descriptively, emphasising the methodological characteristics. The effect sizes of primary outcomes were measured as standardised mean differences. These were computed using Hedges' g, and adjusted for baseline difference and small sample bias (see Other Publications of Related Interest no.1). The pooled effect (...) : to evaluate the efficacy of oral ingestion of milk thistle supplements (silymarin, silybin and silipide) in the treatment of alcohol-related liver disease, viral hepatitis or its sequel, toxin- or drug-induced (other than alcohol) liver disease, cholestasis (pregnancy-related or not), and primary hepatic malignancy. In addition, to evaluate the relative efficacy of different preparations. Harm: to evaluate the clinical adverse effects of supplemental milk thistle ingestion or contact. Searching

2000 DARE.

123697. Prophylactic ephedrine prevents hypotension during spinal anesthesia for Cesarean delivery but does not improve neonatal outcome: a quantitative systematic review

. The continuous data were pooled using the weighted mean difference method and the 95% CIs were calculated. The number-needed-to-treat to prevent maternal hypotension was calculated using a baseline risk of 80%. Publication bias was assessed using a funnel plot for the results on hypotension. How were differences between studies investigated? Statistical heterogeneity was assessed using the Q statistic, taking a p-value of less than 0.10 to indicate heterogeneity. Where heterogeneity was found, those studies (...) to 7.29. Foetal acidosis (6 RCTs, n=350): there was no significant difference between ephedrine and control in the number of neonates with acidosis (RR 1.36, 95% CI: 0.55, 3.35). Standard base excess: there was no significant difference between ephedrine and control for arterial base excess. The weighted mean difference (3 RCTs, n=110) was -0.85 (95% CI: -2.32, +0.61). There was no evidence of publication bias in the funnel plot (intercept p=0.41). Authors' conclusions Prophylactic ephedrine was more

2002 DARE.

123698. Acute pancreatitis and the role of histamine-2 receptor antagonists: a meta-analysis of randomized controlled trials of cimetidine

disagreements were resolved by discussion and consensus was reached. Methods of synthesis How were the studies combined? Weighted descriptive means, along with the confidence intervals (CIs), and the mean values for a variety of study characteristics were calculated. For binary data, an odds ratio (OR) and 95% CI was calculated using the fixed-effect model weighted by the Mantel-Haenszel method. For continuous data, the treatment effect was calculated as the difference between the treatment and the placebo (...) and placebo. The weighted mean difference for cimetidine minus placebo was 6.96 hours (95% CI: -2.50, +16.43). There was no evidence of heterogeneity (P=0.145). Only two studies reported the dose of analgesia but the names of the analgesics were not specified. No more than two studies reported the duration of fever, leucocytosis or hospitalisation. Deleting the studies one at a time did not alter the results for complications (ORs ranged from 1.35 to 1.94) or duration of pain (weighted mean differences

2002 DARE.

123699. Early enteral nutrition in acutely ill patients: a systematic review

to calculate the pooled relative risk (RR) or weighted mean difference (WMD) with 95% confidence intervals (CIs). How were differences between studies investigated? Subgroup analyses were performed for post-operative, trauma, head- injury and burn groups; these were selected because they represent the main clinical populations included in the trials. Heterogeneity between trials was tested using a chi-squared test, where a P-value of less than or equal to 0.05 indicated significant heterogeneity. Results (...) ); and results for each outcome variable. Where the standard deviation for mean hospital stay was not reported, this was computed from the observed mean differences and the test statistics, or by using reported P-values and tables for the normal distribution. Methods of synthesis How were the studies combined? Infections, complications and mortality were treated as binary variables; length of hospital stay was treated as a continuous variable. A meta-analysis using a random-effects model was used

2001 DARE.

123700. Current evidence for the use of botulinum toxin type A in the management of children with cerebral palsy: a systematic review

result. Additional data extracted from the non-randomised studies were the study aim, objective outcome, and the number of groups. Data required to assess methodological quality were also extracted from the RCTs. Methods of synthesis How were the studies combined? A meta-analysis using a fixed-effect model was used to calculate the pooled weighted risk difference, along with 95% confidence intervals (CIs), for the noncontinuous outcomes reported in the RCTs. Summary tables of the non-randomised (...) studies were constructed, and their findings were discussed separately. How were differences between studies investigated? A chi-squared statistical test for heterogeneity was used in the meta-analyses. The only means of evaluating differences between the non-randomised studies was to examine the tables. Results of the review Ten RCTs (n=407) and 7 prospective non-randomised studies (n=193) were included. The methodological quality of the included RCTs was moderate to high (at least 7 points out

2001 DARE.

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