The production of guidelines for the management of drug-resistant tuberculosis (TB) fits the mandate of the World Health Organization (WHO) to support countries in the reinforcement of patient care. ...WHO commissioned external reviews to summarise evidence on priority questions regarding case-finding, treatment regimens for multidrug-resistant TB (MDR-TB), monitoring the response to MDR-TB treatment, and models of care. A multidisciplinary expert panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to develop recommendations. The recommendations support the wider use of rapid drug susceptibility testing for isoniazid and rifampicin or rifampicin alone using molecular techniques. Monitoring by sputum culture is important for early detection of failure during treatment. Regimens lasting ≥ 20 months and containing pyrazinamide, a fluoroquinolone, a second-line injectable drug, ethionamide (or prothionamide), and either cycloserine or p-aminosalicylic acid are recommended. The guidelines promote the early use of antiretroviral agents for TB patients with HIV on second-line drug regimens. Systems that primarily employ ambulatory models of care are recommended over others based mainly on hospitalisation. Scientific and medical associations should promote the recommendations among practitioners and public health decision makers involved in MDR-TB care. Controlled trials are needed to improve the quality of existing evidence, particularly on the optimal composition and duration of MDR-TB treatment regimens.
Background
Throughout the last decade substantial research has been undertaken to develop evidence‐based behaviour change interventions for sexual health promotion. Primary care could provide an ...opportunistic entry for brief sexual health communication.
Objectives
We conducted a systematic review to explore opportunistic sexual and reproductive health services for sexual health communication delivered at primary health care level.
Search strategy
We searched for studies on PubMed, ProQuest, CINAHL, Jstor, Scopus/Science Direct, Cochrane database of systematic reviews, EBSCO, CINAHL, PsychoInfo, and Web of Knowledge. Both published and unpublished articles were reviewed.
Selection criteria
All randomised controlled trials and controlled clinical trials were included. Participants of all ages, from adolescence onwards were included. Brief (10–60 minutes) interventions including some aspect of communication on sexual health issues were included.
Data collection and analysis
Data were extracted by two reviewers independently using a standardised form. Interventions differed from each other, hence meta‐analysis was not performed, and results are presented individually.
Main results
A total of 247 articles were selected for full‐text evaluation, 31 of which were included. Sexually transmitted infections (STIs)/HIV were less often reported in the intervention group compared with the control group. Condom use was higher in most studies in the intervention group. Numbers of sexual partners and unprotected sexual intercourse were lower in the intervention groups.
Conclusions
There is evidence that brief counselling interventions have some effect in the reduction and prevention of STIs/HIV. Some questions could not be answered, such as the effect over time and in different settings and population groups.
Surgical abortion up to 63 days by vacuum aspiration or dilatation and curettage has been the method of choice since the 1960s. Medical abortion became an alternative method of first trimester ...pregnancy termination with the availability of prostaglandins in the early 1970s and anti-progesterones in the 1980s. The most widely researched drugs are prostaglandins (PGs) alone, mifepristone alone, methotrexate alone, mifepristone with prostaglandins and methotrexate with prostaglandins.
To compare different medical methods for first trimester abortion.
The Cochrane Controlled Trials Register, MEDLINE and Popline were systematically searched. Reference lists of retrieved papers were also searched. Experts in WHO/HRP were contacted.
Types of studies. Randomised controlled trials comparing different medical methods (e.g. single drug, combination), ways of application, or different dose regimens, single or combined, for medical abortion, were considered. Trials were assessed and included if they had adequate concealment of allocation, randomisation procedure and follow-up. Women, pregnant in the first trimester, undergoing medical abortion were the participants. Different medical methods used for first trimester abortion, compared with each other or placebo were included. The outcomes sought include mortality, failure to achieve complete abortion, surgical evacuation (as emergency procedure, non-emergency procedure, or undefined), ongoing pregnancy at follow-up, time until passing of conceptus (> 3-6 hours), blood transfusion, blood loss (measured or clinically relevant drop in haemoglobin), days of bleeding, pain resulting from the procedure (reported by the women or measured by use of analgesics), additional uterotonics used, women's dissatisfaction with the procedure, nausea, vomiting, diarrhoea.
Two reviewers independently selected trials for inclusion from the results of the search strategy described previously. The selection of trials for inclusion in the review was performed independently by two reviewers after employing the search strategy described previously. Trials under consideration were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. A form was designed to facilitate the data extraction. Data were processed using Revman software.
Thirty-nine trials were included in the review. The effectiveness outcomes below refer to 'failure to achieve complete abortion' with the intended method unless otherwise stated. 1) Combined regimen mifepristone/prostaglandin: Mifepristone 600 mg compared to 200 mg shows similar effectiveness in achieving complete abortion (4 trials, RR 1.07, 95% CI 0.87 to 1.32). Misoprostol administered orally is less effective (more failures) than the vaginal route (RR 3.00, 95% CI 1.44 to 6.24) and may be associated with more frequent side effects such as nausea and diarrhoea. 2) Mifepristone alone is less effective compared to the combined regimen mifepristone/prostaglandin (RR 3.76 95% CI 2.30 to 6.15). 3) Similarly, the 5 trials included in the comparison of prostaglandin compared to the combined regimen reported in all but one higher effectiveness with the combined regime compared to prostaglandin. The results of these studies were not pooled but the RR of failure with prostaglandin alone is between 1.4 to 3.75 and the 95% confidence intervals indicate statistical significance. 4) In one trial comparing gemeprost 0.5 mg with misoprostol 800 mcg, misoprostol was more effective (failure with gemeprost: RR 2.86, 95% CI 1.14 to 7.18). 5) There was no difference when using split dose compared to single dose of prostaglandin. 6) Combined regimen methotrexate/prostaglandin: there was no statistically significant difference in failure to achieve complete abortion comparing methotrexate administered intramuscular to oral (RR 2.04, 95% CI 0.51 to 8.07). Similarly, early (day 3) vs late (day 5) administration of prostaglandin showed no significant of prostaglandin showed no significant difference (RR 0.72, 95% CI 0.36 to 1.43). One trial compared the effect of tamoxifen vs methotrexate and no statistically significant differences were observed in effectiveness between the groups.
Safe and effective medical abortion methods are available. Combined regimens are more effective than single agents. In the combined regimen, the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness. Misoprostol vaginally is more effective than orally. Some of the results are based on small studies only and therefore carry some uncertainty. Almost all trials were conducted in hospital settings with good access to support and emergency services. It is therefore not clear if the results are readily applicable to under-resourced settings where such services are lacking even if the agents used are available.
Management of breech presentation is controversial, both in regard to manipulation of the position of the fetus and the method of delivery. External cephalic version may reduce the number of breech ...presentations and caesarean sections, but there also have been reports of increased perinatal mortality with the procedure.
The objective of this review was to assess the effects of external cephalic version at term on measures of pregnancy outcome.
The Cochrane Pregnancy and Childbirth trials register was searched. Date of last search: October 1997.
Randomised trials of external cephalic version at term (with or without tocolysis) compared with no attempt at external cephalic version in women with breech presentation.
Eligibility and trial quality were assessed by GJH and checked by RK.
Six studies were included. External cephalic version at term was associated with a significant reduction in non-cephalic births (relative risk 0.42, 95% confidence interval 0.35 to 0.50) and caesarean section (relative risk 0.52, 95% confidence interval 0.39 to 0.71). There was no significant effect on perinatal mortality (relative risk 0.44, 95% confidence interval 0.07 to 2.92).
Attempting cephalic version at term appears to reduce the chance of non-cephalic births and caesarean section. There is not enough evidence to assess any risks of external cephalic version at term.
Intrauterine devices (IUD) are safe and effective methods of long term reversible contraception. The design, and copper content as well as placement of the copper on IUDs could affect their ...effectiveness and side-effect profile.
We compared different copper IUDs for their effectiveness and side effects.
Multiple electronic databases were searched with appropriate key words and names of the IUDs known to be in the market. We searched the reference lists of papers identified and contacted trialists when possible. There was no language restriction.
Randomised controlled trials comparing different IUDs were considered. Trials needed to report on clinical outcomes.
Data on outcomes and trial characteristics were extracted in duplicate and independently by two reviewers. Meta-analysis results are expressed as rate difference (RD) using a fixed-effects model with 95% confidence interval (CI). In the presence of significant heterogeneity a random-effects model was applied.
We included 35 trials, resulting in 18 comparisons of 10 different IUDs in approximately 48,000 women. TCu380A was more effective in preventing pregnancy than MLCu375 (RD 1.70%, 95% CI 0.07% to 2.95% after 4 years of use). TCu380A was also more effective than MLCu250, TCu220 and TCu200. There tended to be fewer pregnancies with TCu380S compared to TCu380A after the first year of use, a difference which was statistically significant in the fourth year (RD -1.62%, 95% CI -3.00% to -0.24%). This occurred despite more expulsions with TCu380S (RD 3.50%, 95% CI 0.36% to 6.63% at 4 years). MLCu375 was no more effective than TCu220 at 1 year of use, or MLCu250 and NovaT up to 3 years. Compared to TCu380A or TCu380S, none of the IUDs showed any benefits in terms of bleeding or pain, or any of the other reasons for early discontinuation. None of the trials that reported events at insertion found one IUD easier to insert than another or caused less pain at insertion. There is no evidence that uterine perforation rates vary by type of device. There are minimal randomised data on IUD use in nulliparous women.
TCu380A or TCu380S appear to be more effective than other IUDs. No IUD showed consistently lower removal rates for bleeding and pain in comparison to other IUDs. There is no evidence that any particular framed copper device is better suited to women who have not had children.
Lateral and posterior position of the baby's head (the back of the baby's head facing to the mother's side or back) may be associated with more painful, prolonged or obstructed labour and difficult ...delivery. It is possible that certain positions adopted by the mother may influence the baby's position.
To assess the effects of adopting a hands and knees maternal posture in late pregnancy or during labour when the presenting part of the fetus is in a lateral or posterior position compared with no intervention.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (July 2007) and the Cochrane Central Register of Controlled Trials (The Cochrane Library 2007, Issue 2).
Randomised trials of hands and knees maternal posture compared to other postures or controls.
Two review authors assessed trial eligibility and quality.
Three trials (2794 women) were included. In one trial (100 women), four different postures (four groups of 20 women) were combined for the comparison with the control group of 20 women. Lateral or posterior position of the presenting part of the fetus was less likely to persist following 10 minutes in the hands and knees position compared to a sitting position (one trial, 100 women, relative risk (RR) 0.26, 95% confidence interval (CI) 0.18 to 0.38). In a second trial (2547 women), advice to assume the hands and knees posture for 10 minutes twice daily in the last weeks of pregnancy had no effect on the baby's position at delivery or any of the other pregnancy outcomes measured. The third trial studied the use of hands and knees position in labour and involved 147 labouring women at 37 or more weeks gestation. Occipito-posterior position of the baby was confirmed by ultrasound. Seventy women, who were randomised in the intervention group, assumed hands and knees positioning for a period of at least 30 minutes, compared to 77 women in the control group who did not assume hands and knees positioning in labour. The reduction in occipito-posterior or -transverse positions at delivery and operative deliveries were not statistically significant. There was a significant reduction in back pain.
Use of hands and knees position for 10 minutes twice daily to correct occipito-posterior position of the fetus in late pregnancy cannot be recommended as an intervention. This is not to suggest that women should not adopt this position if they find it comfortable. The use of position in labour was associated with reduced backache. Further trials are needed to assess the effects on other labour outcomes.
Please cite this paper as: Kulier R, Gee H, Khan K. Five steps from evidence to effect: exercising clinical freedom to implement research findings. BJOG 2008; 115:1197-1202.
Intrauterine devices (IUD) are safe and effective methods of long term reversible contraception. Design and copper content of IUDs could affect their effectiveness and side-effect profile.
We ...compared different copper IUDs for their effectiveness and side effects.
Multiple electronic databases were searched with appropriate key words and names of the IUDs known to be in the market. We searched the reference lists of papers identified and contacted trialists when possible.
Randomised controlled trials comparing different IUDs were considered. Trials needed to report on clinical outcomes.
Data on outcomes and trial characteristics were extracted in duplicate and independently by two reviewers. Meta-analysis results are expressed as rate difference (RD) using a fixed-effects model with 95% confidence interval (CI). In the presence of significant heterogeneity a random-effects model was applied.
We included 34 trials, resulting in 16 comparisons of different IUDs. TCu380A was more effective than MLCu375, MLCu250, TCu220 and TCu200. Changing the position of the copper on the arm of the IUD for TCu380S did not improve the efficacy of TCu380A. MLCu375 was no more effective than TCu220, at 1 year, MLCu250 to 3 years or NovaT to 3 years Compared to TCu380A, none of the IUDs showed any benefits in terms of bleeding or pain, or any of the other reasons for early discontinuation.
TCu380A is more effective compared to other IUDs. There is no data available comparing different IUDs in special subgroups, such as nulliparous women.
Induced abortions are very commonly practiced interventions worldwide. A variety of medical abortion methods have been introduced during the last decade in addition to existing surgical methods. In ...this review we systematically searched for and combined all evidence from randomised controlled trials comparing surgical with medical abortion.
To evaluate medical methods in comparison to surgical methods for first-trimester abortion with respect to efficacy, side effects and acceptability.
The Cochrane Controlled Trials Register, MEDLINE (with the Cochrane 3-stage search strategy)(1966-2000) and Popline (1970-2000) were systematically searched. There were no language preferences in searching. Reference lists of retrieved papers were searched. Experts in WHO/HRP were contacted.
Randomised trials of any surgical abortion method compared with any medical abortion method in the first trimester.
Trial quality was assessed and data extraction was made independently by two reviewers.
Six studies mostly with small sample sizes, comparing 4 different interventions (prostaglandins alone, mifepristone alone, and mifepristone/misoprostol and methotrexate/misoprostol versus vacuum aspiration) were included. Results are sometimes based on one trial only. Prostaglandins vs vacuum aspiration: the rate of abortions not completed with the intended method was statistically significant higher in the prostaglandin group (2.7, 95% CI 1.1 to 6.8) compared to surgery. There are no data on the most commonly medical (mifepristone/misoprostol) and surgical abortion available to be included in the review. Duration of bleeding was longer in the medical abortion groups compared to vacuum aspiration. There was only one major complication (uterine perforation) in one trial in the surgical group. There was no difference between the groups for ongoing pregnancies at the time of follow-up or pelvic infections. No data on acceptability, side effects or women's satisfaction with the procedure were available for inclusion in the review.
The results are derived from relatively small trials. Prostaglandins used alone seems to be less effective and more painful compared to surgical first-trimester abortion. However, there is inadequate evidence to comment on the acceptability and side effects of medical compared to surgical first-trimester abortions. There is a need for trials to address the efficacy of currently used methods and women's preferences more reliably.
The progestogen component of oral contraceptives (OC) has undergone changes since it was first recognised that their chemical structures could influence the spectrum of minor adverse and beneficial ...effects. The major determinants of OCs are effectiveness, cycle control and common side effects. The rationale of this review is to provide a systematic comparison of OCs containing the progestogens currently in use worldwide.
The objective of this review is to compare currently available low-dose OCs containing ethinyl estradiol and different progestogens in terms of contraceptive effectiveness, cycle control, side effects and continuation rates.
The Cochrane Controlled Trials Register, MEDLINE and EMBASE databases have been searched systematically. Relevant pharmaceutical companies and the authors of articles included in this review have been contacted for clarification.
Randomised trials reporting clinical outcomes were considered for inclusion. We excluded studies comparing mono- with multiphasic pills, and crossover trials with trials in which the difference in total content of ethinyl estradiol between preparations exceeded 105 micro g.
The methodological quality and validity of studies were assessed based on the above-mentioned inclusion criteria. Both application of inclusion criteria and data extraction were performed independently by the reviewers. Results are expressed as relative risk (RR) with 95% confidence interval (CI) using a random-effects model.
Twenty-two trials have been included in this review, thus generating 14 comparisons. Eighteen trials were sponsored by pharmaceutical companies and in only 5 cases had a blind trial been attempted. Most comparisons between different interventions included 1-3 trials. There was less discontinuation with second- compared to first-generation progestogens (RR: 0.79, 95% CI: 0.69-0.91). Cycle control appears to be better when using second- compared to first-generation progestogens for both mono- (RR: 0.69; 95% CI: 0.52-0.91) and triphasic (RR: 0.61; 95% CI: 0.43-0.85) preparations.Contraceptive effectiveness, spotting, breakthrough bleeding and the absence of withdrawal bleeding was similar when using GSD compared to LNG, although there was less intermenstrual bleeding in the GSD group (RR: 0.71, 95% CI: 0.55, 0.91). Drospirenone (DRSP) appeared to be similar to DSG.
Based on data from one trial, compared to pills containing LNG, those containing GSD may be associated with less intermenstrual bleeding although they show similar patterns of spotting, breakthrough bleeding and the absence of withdrawal bleeds. GSD is also comparable to DSG. Regarding acceptability, all the indices show that third- and second-generation progestogens are preferred over first-generation preparations. Future research should focus on independently conducted, well-designed randomised trials that compare third- and second-generation progestogens in particular.