Related Articles

Objective To assess the effectiveness of strategies incorporating training and support of traditional birth attendants on the outcomes of perinatal, neonatal, and maternal death in developing countries.

Design Systematic review with meta-analysis.

Data sources Medline, Embase, the Allied and Complementary Medicine database, British Nursing Index, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, BioMed Central, PsycINFO, Latin American and Caribbean Health Sciences Literature database, African Index Medicus, Web of Science, Reproductive Health Library, and Science Citation Index (from inception to April 2011), without language restrictions. Search terms were “birth attend*”, “traditional midwife”, “lay birth attendant”, “dais”, and “comadronas”.

Review methods We selected randomised and non-randomised controlled studies with outcomes of perinatal, neonatal, and maternal mortality. Two independent reviewers undertook data extraction. We pooled relative risks separately for the randomised and non-randomised controlled studies, using a random effects model.

Results We identified six cluster randomised controlled trials (n=138 549) and seven non-randomised controlled studies (n=72 225) that investigated strategies incorporating training and support of traditional birth attendants. All six randomised controlled trials found a reduction in adverse perinatal outcomes; our meta-analysis showed significant reductions in perinatal death (relative risk 0.76, 95% confidence interval 0.64 to 0.88, P<0.001; number needed to treat 35, 24 to 70) and neonatal death (0.79, 0.69 to 0.88, P<0.001; 98, 66 to 170). Meta-analysis of the non-randomised studies also showed a significant reduction in perinatal mortality (0.70, 0.57 to 0.84, p<0.001; 48, 32 to 96) and neonatal mortality (0.61, 0.48 to 0.75, P<0.001; 96, 65 to 168). Six studies reported on maternal mortality and our meta-analysis showed a non-significant reduction (three randomised trials, relative risk 0.79, 0.53 to 1.05, P=0.12; three non-randomised studies, 0.80, 0.44 to 1.15, P=0.26).

Conclusion Perinatal and neonatal deaths are significantly reduced with strategies incorporating training and support of traditional birth attendants.

OBJECTIVES: To compare the judgments of clinicians on which domains of health in the short form questionnaire (SF-36) would be most important to patients with multiple sclerosis with the opinions of patients themselves; to compare assessment of physical disability in multiple sclerosis by a clinician using Kurtzke's expanded disability status scale and a non-clinically qualified assistant using the Office of Population Census and Surveys' (OPCS) disability scale with self assessment of disability and other domains of health related quality of life by patients using the SF-36 and the EuroQol questionnaire; and to compare the scores of patients for each domain of the SF-36 with control data matched for age and sex. DESIGN: Cross sectional study. SETTING: Clinical department of neurology, Edinburgh. SUBJECTS: 42 consecutive patients with multiple sclerosis attending a neurology outpatient clinic for review or a neurology ward for rehabilitation. MAIN OUTCOME MEASURES: Scores on the SF-36; EuroQol; Kurtzke's expanded disability status scale; the OPCS disability scale. RESULTS: Patients and clinicians disagreed on which domains of health status were most important (chi 2 = 21, df = 7, P = 0.003). Patients' assessment of their physical disability using the physical functioning domain of the SF-36 was highly correlated with the clinicians' assessment (r = -0.87, P < 0.001) and the non-clinical assessment (r = -0.90, P < 0.001). However, none of the measures of physical disability correlated with overall health related quality of life measured with EuroQol, Quality of life correlated with vitality, general health, and mental health in the SF-36, each of which patients rated as more important than clinicians and for each of which patients scored lower than the controls. CONCLUSIONS: Patients with multiple sclerosis and possibly those with other chronic diseases are less concerned than their clinicians about physical disability in their illness. Clinical trials in multiple sclerosis should assess the effect of treatment on the other elements of health status that patients consider important, which are also affected by the disease process, are more closely related to overall health related quality of life, and may well be adversely affected by side effects of treatment.

Background

The striking increase in caesarean section rates in middle and high-income countries has been partly attributed to maternal request. We conducted a systematic review and meta-analysis of women’s preferences for caesarean section.

Objectives

To review the published literature on women’s preferences for caesarean section.

Search strategy

A systematic search of MEDLINE, EMBASE, LILACS and PsychINFO was performed. References of all included articles were examined.

Selection criteria

We included studies that quantitatively evaluated women’s preferences for caesarean section in any country. We excluded articles assessing health providers’ preferences and qualitative studies.

Data collection and analysis

Two reviewers independently screened abstracts of all identified citations, selected potentially eligible studies, and assessed their full-text versions. We conducted a meta-analysis of proportions, and a meta-regression analysis to determine variables significantly associated with caesarean section preference.

Main Results

38 studies were included (n= 19,403). The overall pooled preference for caesarean section was 15.6% (95% CI: 12.5–18.9). Higher preference for caesarean section was reported in women with a previous caesarean section versus women without a previous caesarean section (29.4% – 95% CI: 24.4 to 34.8 - versus 10.1% – 95% CI: 7.5 to 13.1), and those living in a middle-income country versus a high-income country (22.1% –95% CI: 17.6 to 26.9 -versus 11.8% – 95% CI: 8.9 to 15.1).

Conclusions

Only a minority of women in a wide variety of countries expressed a preference for caesarean delivery. Further research is needed to better estimate the contribution of women’s demand to the rising caesarean section rates.

Objective To evaluate the association of chocolate consumption with the risk of developing cardiometabolic disorders.

Design Systematic review and meta-analysis of randomised controlled trials and observational studies.

Data sources Medline, Embase, Cochrane Library, PubMed, CINAHL, IPA, Web of Science, Scopus, Pascal, reference lists of relevant studies to October 2010, and email contact with authors.

Study selection Randomised trials and cohort, case-control, and cross sectional studies carried out in human adults, in which the association between chocolate consumption and the risk of outcomes related to cardiometabolic disorders were reported.

Data extraction Data were extracted by two independent investigators, and a consensus was reached with the involvement of a third. The primary outcome was cardiometabolic disorders, including cardiovascular disease (coronary heart disease and stroke), diabetes, and metabolic syndrome. A meta-analysis assessed the risk of developing cardiometabolic disorders by comparing the highest and lowest level of chocolate consumption.

Results From 4576 references seven studies met the inclusion criteria (including 114 009 participants). None of the studies was a randomised trial, six were cohort studies, and one a cross sectional study. Large variation was observed between these seven studies for measurement of chocolate consumption, methods, and outcomes evaluated. Five of the seven studies reported a beneficial association between higher levels of chocolate consumption and the risk of cardiometabolic disorders. The highest levels of chocolate consumption were associated with a 37% reduction in cardiovascular disease (relative risk 0.63 (95% confidence interval 0.44 to 0.90)) and a 29% reduction in stroke compared with the lowest levels.

Conclusions Based on observational evidence, levels of chocolate consumption seem to be associated with a substantial reduction in the risk of cardiometabolic disorders. Further experimental studies are required to confirm a potentially beneficial effect of chocolate consumption.

Objective

To determine whether nurse practitioners can provide care at first point of contact equivalent to doctors in a primary care setting.

Design

Systematic review of randomised controlled trials and prospective observational studies.

Data sources

Cochrane controlled trials register, specialist register of trials maintained by Cochrane Effective Practice and Organisation of Care Group, Medline, Embase, CINAHL, science citation index, database of abstracts of reviews of effectiveness, national research register, hand searches, and published bibliographies.

Included studies

Randomised controlled trials and prospective observational studies comparing nurse practitioners and doctors providing care at first point of contact for patients with undifferentiated health problems in a primary care setting and providing data on one or more of the following outcomes: patient satisfaction, health status, costs, and process of care.

Results

11 trials and 23 observational studies met all the inclusion criteria. Patients were more satisfied with care by a nurse practitioner (standardised mean difference 0.27, 95% confidence interval 0.07 to 0.47). No differences in health status were found. Nurse practitioners had longer consultations (weighted mean difference 3.67 minutes, 2.05 to 5.29) and made more investigations (odds ratio 1.22, 1.02 to 1.46) than did doctors. No differences were found in prescriptions, return consultations, or referrals. Quality of care was in some ways better for nurse practitioner consultations.

Conclusion

Increasing availability of nurse practitioners in primary care is likely to lead to high levels of patient satisfaction and high quality care.

What is already known on this topicNurse practitioners have existed in North America for many yearsAn increasing number of such nurses are being employed in the United Kingdom in general practice, emergency departments, and other primary care settingsReviews suggest that nurse practitioners are equivalent to doctors on most variables studied, but the relevance of this in the context of the NHS is unclearWhat this study addsPatients are more satisfied with care from a nurse practitioner than from a doctor, with no difference in health outcomesNurse practitioners provide longer consultations and carry out more investigations than doctorsMost recent research has related to patients requesting same day appointments for minor illness, which is only a limited part of a doctor's role

Objectives To quantify the benefits and harms of general health checks in adults with an emphasis on patient-relevant outcomes such as morbidity and mortality rather than on surrogate outcomes.

Design Cochrane systematic review and meta-analysis of randomised trials. For mortality, we analysed the results with random effects meta-analysis, and for other outcomes we did a qualitative synthesis as meta-analysis was not feasible.

Data sources Medline, EMBASE, Healthstar, Cochrane Library, Cochrane Central Register of Controlled Trials, CINAHL, EPOC register, ClinicalTrials.gov, and WHO ICTRP, supplemented by manual searches of reference lists of included studies, citation tracking (Web of Knowledge), and contacts with trialists.

Selection criteria Randomised trials comparing health checks with no health checks in adult populations unselected for disease or risk factors. Health checks defined as screening general populations for more than one disease or risk factor in more than one organ system. We did not include geriatric trials.

Data extraction Two observers independently assessed eligibility, extracted data, and assessed the risk of bias. We contacted authors for additional outcomes or trial details when necessary.

Results We identified 16 trials, 14 of which had available outcome data (182 880 participants). Nine trials provided data on total mortality (11 940 deaths), and they gave a risk ratio of 0.99 (95% confidence interval 0.95 to 1.03). Eight trials provided data on cardiovascular mortality (4567 deaths), risk ratio 1.03 (0.91 to 1.17), and eight on cancer mortality (3663 deaths), risk ratio 1.01 (0.92 to 1.12). Subgroup and sensitivity analyses did not alter these findings. We did not find beneficial effects of general health checks on morbidity, hospitalisation, disability, worry, additional physician visits, or absence from work, but not all trials reported on these outcomes. One trial found that health checks led to a 20% increase in the total number of new diagnoses per participant over six years compared with the control group and an increased number of people with self reported chronic conditions, and one trial found an increased prevalence of hypertension and hypercholesterolaemia. Two out of four trials found an increased use of antihypertensives. Two out of four trials found small beneficial effects on self reported health, which could be due to bias.

Conclusions General health checks did not reduce morbidity or mortality, neither overall nor for cardiovascular or cancer causes, although they increased the number of new diagnoses. Important harmful outcomes were often not studied or reported.

Systematic review registration Cochrane Library, doi:10.1002/14651858.CD009009.

Background

Plethysmography and rheography techniques have been widely studied as diagnostic tests for deep vein thrombosis (DVT). This study aimed to systematically review the accuracy of these tests for diagnosing clinically suspected DVT.

Methods

The following databases were searched: Medline, EMBASE, CINAHL, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, Database of Reviews of Effectiveness, the ACP Journal Club (1966 to 2004), and citation lists of retrieved articles. Studies that compared plethysmography or rheography to a reference standard of ultrasound or contrast venography were selected. Standardised data were extracted and study quality determined against validated criteria. Data were analysed by random effects meta‐analysis and meta‐regression.

Results

The meta‐analysis included 78 studies, reporting 82 patient cohorts. Sensitivity and specificity (95% CI) were: 75% (73% to 77%) and 90% (89% to 91%) for impedance plethysmography, 83% (81% to 85%) and 81% (79% to 82%) for strain‐gauge plethysmography, 85% (79% to 90%) and 91% (81% to 95%) for air plethysmography, 91% (87% to 94%) and 71% (66% to 75%) for light‐reflex rheography, and 86% (83% to 89%) and 93% (91% to 95%) for phleborheography. Meta‐regression was limited by poor reporting of studies. There was some evidence that diagnostic performance depended on the proportion of males in the cohort and reporting of study setting.

Conclusions

Although plethysmography and rheography techniques add diagnostic value, they have inadequate diagnostic performance to act as a stand‐alone test in DVT diagnosis. Evaluation of their role in combination with other tests, or standardised clinical assessment, is required.

Objective

To assess the effectiveness of citalopram for major depressive disorder (MDD) in adults, in a systematic review of all published, randomised, double-blind studies comparing it with a placebo.

Data sources

Cochrane Central Register of Controlled Trials, Medline, PsychINFO and Embase.

Study selection

Randomised, double-blind, placebo-controlled studies of citalopram in adults with MDD were included. Studies with medically ill or treatment resistant subjects were excluded, as were studies of relapse prevention. Remission of MDD was defined as a primary outcome, and response or change from baseline scores were defined as secondary.

Data extraction

Remission, response and symptom improvement scores on the Hamilton Depression Scale, Montgomery–Asberg Depression Rating Scale and Clinical Global Impressions-Severity scales were extracted. A random-effects meta-analysis was carried out on the response rates and symptom improvement scores. Included studies were examined for the presence of bias and small study effects.

Results

Eight studies (n=2025) met the inclusion criteria. Two studies provided data on remission, but only one of these showed a significant difference between citalopram and placebo (RR=1.59, 95% CI 1.10 to 2.31). Meta-analysis of response rates in five studies (n=1010) revealed significant superiority of citalopram (RR=1.42, 95% CI 1.17 to 1.73). Meta-analysis of change from baseline scores in five studies (n=1541) gave a standardised mean difference (Hedges' g) of −0.27 (95% CI −0.38 to to −0.16), showing a reduction in MDD symptoms to be significant for citalopram relative to placebo. There was no evidence of any significant small study effects. The overall quality of reporting was poor, with insufficient information on the methodology or outcomes. Seven studies received industry sponsorship.

Conclusions

Data concerning remission rates for citalopram, relative to placebo, are inconclusive. Response rates and symptom reduction scores in citalopram-treated patients with MDD are significantly better relative to placebo treatment, according to a meta-analysis of published reports. Evaluation of unpublished data is necessary to assess more definitively the effectiveness of citalopram for MDD.

Article summary

Article focus

Systematic review and meta-analysis of published randomised double-blind studies comparing citalopram with placebo in adults with major depressive disorder (MDD).

Evaluation of the quality of published studies and the risk of bias.

Key messages

Data on remission rates for citalopram in MDD, relative to placebo, are inconclusive

Response rates and symptom improvement scores are significantly better in citalopram-treated patients than in those taking placebo.

The quality of reporting in published studies is poor.

Further evaluation of citalopram is necessary, incorporating unpublished research.

Strengths and limitations of this study

This review is based on a thorough search for published placebo-controlled studies of citalopram for adults with MDD, using a broad search strategy. In a departure from previously published reviews, this study assesses the risk of bias and includes remission as a primary outcome.

This study would have been enhanced if the missing data were available for a more complete analysis, and unpublished studies satisfying inclusion criteria were incorporated into this review.

This review was carried out by a single author.

Objective To assess the effect of tranexamic acid on blood transfusion, thromboembolic events, and mortality in surgical patients.

Design Systematic review and meta-analysis.

Data sources Cochrane central register of controlled trials, Medline, and Embase, from inception to September 2011, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of relevant articles.

Study selection Randomised controlled trials comparing tranexamic acid with no tranexamic acid or placebo in surgical patients. Outcome measures of interest were the number of patients receiving a blood transfusion; the number of patients with a thromboembolic event (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism); and the number of deaths. Trials were included irrespective of language or publication status.

Results 129 trials, totalling 10 488 patients, carried out between 1972 and 2011 were included. Tranexamic acid reduced the probability of receiving a blood transfusion by a third (risk ratio 0.62, 95% confidence interval 0.58 to 0.65; P<0.001). This effect remained when the analysis was restricted to trials using adequate allocation concealment (0.68, 0.62 to 0.74; P<0.001). The effect of tranexamic acid on myocardial infarction (0.68, 0.43 to 1.09; P=0.11), stroke (1.14, 0.65 to 2.00; P=0.65), deep vein thrombosis (0.86, 0.53 to 1.39; P=0.54), and pulmonary embolism (0.61, 0.25 to 1.47; P=0.27) was uncertain. Fewer deaths occurred in the tranexamic acid group (0.61, 0.38 to 0.98; P=0.04), although when the analysis was restricted to trials using adequate concealment there was considerable uncertainty (0.67, 0.33 to 1.34; P=0.25). Cumulative meta-analysis showed that reliable evidence that tranexamic acid reduces the need for transfusion has been available for over 10 years.

Conclusions Strong evidence that tranexamic acid reduces blood transfusion in surgery has been available for many years. Further trials on the effect of tranexamic acid on blood transfusion are unlikely to add useful new information. However, the effect of tranexamic acid on thromboembolic events and mortality remains uncertain. Surgical patients should be made aware of this evidence so that they can make an informed choice.

Objective To compare the effects of low concentration epidural infusions of bupivacaine with parenteral opioid analgesia on rates of caesarean section and instrumental vaginal delivery in nulliparous women.

Data sources Medline, Embase, the Cochrane controlled trials register, and handsearching of the International Journal of Obstetric Anesthesia.

Study selection Randomised controlled trials comparing low concentration epidural infusions with parenteral opioids.

Data synthesis Seven trials fulfilled the inclusion criteria for meta-analysis. Epidural analgesia does not seem to be associated with an increased risk of caesarean section (odds ratio 1.03, 95% confidence interval 0.71 to 1.48) but may be associated with an increased risk of instrumental vaginal delivery (2.11, 0.95 to 4.65). Epidural analgesia was associated with a longer second stage of labour (weighted mean difference 15.2 minutes, 2.1 to 28.2 minutes). More women randomised to receive epidural analgesia had adequate pain relief, with fewer changing to parenteral opioids than vice versa (odds ratio 0.1, 0.05 to 0.22).

Conclusions Epidural analgesia using low concentration infusions of bupivacaine is unlikely to increase the risk of caesarean section but may increase the risk of instrumental vaginal delivery. Although women receiving epidural analgesia had a longer second stage of labour, they had better pain relief.

Background

To assess whether domestic kitchen hygiene is an important contributor to the development of diarrhoea in the developed world.

Methods

Electronic searches were carried out in October 2006 in EMBASE, MEDLINE, Web of Knowledge, Cochrane central register of clinical trials and CINAHL. All publications, irrespective of study design, assessing food hygiene practices with an outcome measure of diarrhoea were included in the review. All included studies underwent data extraction and the data was subsequently analysed. The analysis was conducted by qualitative synthesis of the results. Given the substantial heterogeneity in study design and outcome measures meta-analysis was not done. In addition the existing dataset of the UK IID study was reanalysed to investigate possible associations between self-reported diarrhoea and variables indicative of poor domestic kitchen hygiene

Results

Some 14 studies were finally included in subsequent analyses. Of the 14 studies included in this systematic review, 11 were case-control studies, 2 cross-sectional surveys, and 1 RCT. Very few studies identified any significant association with good environmental kitchen hygiene. Although some of the variables in the reanalysis of the UK IID study were statistically significant no obvious trend was seen.

Conclusion

The balance of the available evidence does not support the hypothesis that poor domestic kitchen hygiene practices are important risk factors for diarrhoeal disease in developed countries.

Objective To determine whether the ethnicity of UK trained doctors and medical students is related to their academic performance.

Design Systematic review and meta-analysis.

Data sources Online databases PubMed, Scopus, and ERIC; Google and Google Scholar; personal knowledge; backwards and forwards citations; specific searches of medical education journals and medical education conference abstracts.

Study selection The included quantitative reports measured the performance of medical students or UK trained doctors from different ethnic groups in undergraduate or postgraduate assessments. Exclusions were non-UK assessments, only non-UK trained candidates, only self reported assessment data, only dropouts or another non-academic variable, obvious sampling bias, or insufficient details of ethnicity or outcomes.

Results 23 reports comparing the academic performance of medical students and doctors from different ethnic groups were included. Meta-analyses of effects from 22 reports (n=23 742) indicated candidates of “non-white” ethnicity underperformed compared with white candidates (Cohen’s d=−0.42, 95% confidence interval −0.50 to −0.34; P<0.001). Effects in the same direction and of similar magnitude were found in meta-analyses of undergraduate assessments only, postgraduate assessments only, machine marked written assessments only, practical clinical assessments only, assessments with pass/fail outcomes only, assessments with continuous outcomes only, and in a meta-analysis of white v Asian candidates only. Heterogeneity was present in all meta-analyses.

Conclusion Ethnic differences in academic performance are widespread across different medical schools, different types of exam, and in undergraduates and postgraduates. They have persisted for many years and cannot be dismissed as atypical or local problems. We need to recognise this as an issue that probably affects all of UK medical and higher education. More detailed information to track the problem as well as further research into its causes is required. Such actions are necessary to ensure a fair and just method of training and of assessing current and future doctors.

The purpose of this meta-analytic review was to quantify the effects of psychological therapies for the management of chronic pain in youth. Specifically, in this review we updated previous systematic reviews of randomized controlled trials by including new trials, and by adding disability and emotional functioning to pain as treatment outcomes. Electronic searches of the Cochrane Register of Randomised Controlled Trials, MEDLINE, PsycLIT, EMBASE, and the Social Sciences Citation Index were conducted from inception through August 2008. Methodological quality of the studies was assessed, and data extracted on the three primary outcomes of interest. Twenty-five trials including 1247 young people met inclusion criteria and were included in the meta-analysis. Meta-analytic findings demonstrated a large positive effect of psychological intervention on pain reduction at immediate post-treatment and follow-up in youth with headache, abdominal pain, and fibromyalgia. Small and non-significant effects were found for improvements in disability and emotional functioning, although there were limited data on these outcomes available in the included studies. Omnibus cognitive-behavioral therapy, relaxation therapy, and biofeedback all produced significant and positive effects on pain reduction. Studies directly comparing the effects of self-administered versus therapist-administered interventions found similar effects on pain reduction. Psychological therapies result in improvement in pain relief across several different pain conditions in children. Future trials are needed that incorporate non-pain outcome domains, that focus significant therapeutic content on reductions in disability, and that include extended follow up to better understand maintenance of treatment effects.

Objective

To compare the risk of stillbirth and miscarriage in a subsequent pregnancy in women with a previous Caesarean or vaginal delivery.

Design

Systematic review of the published literature including seven databases: CINAHL; the Cochrane library; Embase; Medline; PubMed; SCOPUS and Web of Knowledge from 1945 until November 11th 2011, using a detailed search-strategy and cross-checking of reference lists.

Study Selection

Cohort, case-control and cross-sectional studies examining the association between previous Caesarean section and subsequent stillbirth or miscarriage risk. Two assessors screened titles to identify eligible studies, using a standardised data abstraction form and assessed study quality.

Data synthesis

11 articles were included for stillbirth, totalling 1,961,829 pregnancies and 7,308 events. Eight eligible articles were included for miscarriage, totalling 147,017 pregnancies and 12,682 events. Pooled estimates across the stillbirth studies were obtained using random-effect models. Among women with a previous Caesarean an increase in odds of 1.23 [95% CI 1.08, 1.40] for stillbirth was yielded. Subgroup analyses including unexplained stillbirths yielded an OR of 1.47 [95% CI 1.20, 1.80], an OR of 2.11 [95% CI 1.16, 3.84] for explained stillbirths and an OR of 1.27 [95% CI 0.95, 1.70] for antepartum stillbirths. Only one study reported adjusted estimates in the miscarriage review, therefore results are presented individually.

Conclusions

Given the recent revision of the National Institute for Health and Clinical Excellence guidelines (NICE), providing women the right to request a Caesarean, it is essential to establish whether mode of delivery has an association with subsequent risk of stillbirth or miscarriage. Overall, compared to vaginal delivery, the pooled estimates suggest that Caesarean delivery may increase the risk of stillbirth by 23%. Results for the miscarriage review were inconsistent and lack of adjustment for confounding was a major limitation. Higher methodological quality research is required to reliably assess the risk of miscarriage in subsequent pregnancies.

Objective To assess the effect of targeting intensive glycaemic control versus conventional glycaemic control on all cause mortality and cardiovascular mortality, non-fatal myocardial infarction, microvascular complications, and severe hypoglycaemia in patients with type 2 diabetes.

Design Systematic review with meta-analyses and trial sequential analyses of randomised trials.

Data sources Cochrane Library, Medline, Embase, Science Citation Index Expanded, LILACS, and CINAHL to December 2010; hand search of reference lists and conference proceedings; contacts with authors, relevant pharmaceutical companies, and the US Food and Drug Administration.

Study selection Randomised clinical trials comparing targeted intensive glycaemic control with conventional glycaemic control in patients with type 2 diabetes. Published and unpublished trials in all languages were included, irrespective of predefined outcomes.

Data extraction Two reviewers independently assessed studies for inclusion and extracted data related to study methods, interventions, outcomes, risk of bias, and adverse events. Risk ratios with 95% confidence intervals were estimated with fixed and random effects models.

Results Fourteen clinical trials that randomised 28 614 participants with type 2 diabetes (15 269 to intensive control and 13 345 to conventional control) were included. Intensive glycaemic control did not significantly affect the relative risks of all cause (1.02, 95% confidence interval 0.91 to 1.13; 28 359 participants, 12 trials) or cardiovascular mortality (1.11, 0.92 to 1.35; 28 359 participants, 12 trials). Trial sequential analyses rejected a relative risk reduction above 10% for all cause mortality and showed insufficient data on cardiovascular mortality. The risk of non-fatal myocardial infarction may be reduced (relative risk 0.85, 0.76 to 0.95; P=0.004; 28 111 participants, 8 trials), but this finding was not confirmed in trial sequential analysis. Intensive glycaemic control showed a reduction of the relative risks for the composite microvascular outcome (0.88, 0.79 to 0.97; P=0.01; 25 600 participants, 3 trials) and retinopathy (0.80, 0.67 to 0.94; P=0.009; 10 793 participants, 7 trials), but trial sequential analyses showed that sufficient evidence had not yet been reached. The estimate of an effect on the risk of nephropathy (relative risk 0.83, 0.64 to 1.06; 27 769 participants, 8 trials) was not statistically significant. The risk of severe hypoglycaemia was significantly increased when intensive glycaemic control was targeted (relative risk 2.39, 1.71 to 3.34; 27 844 participants, 9 trials); trial sequential analysis supported a 30% increased relative risk of severe hypoglycaemia.

Conclusion Intensive glycaemic control does not seem to reduce all cause mortality in patients with type 2 diabetes. Data available from randomised clinical trials remain insufficient to prove or refute a relative risk reduction for cardiovascular mortality, non-fatal myocardial infarction, composite microvascular complications, or retinopathy at a magnitude of 10%. Intensive glycaemic control increases the relative risk of severe hypoglycaemia by 30%.

Objective To compare the safety and clinical outcomes of enteral and parenteral nutrition in patients with acute pancreatitis.

Data sources Medline, Embase, Cochrane controlled trials register, and citation review of relevant primary and review articles.

Study selection Randomised controlled studies that compared enteral nutrition with parenteral nutrition in patients with acute pancreatitis. From 117 articles screened, six were identified as randomised controlled trials and were included for data extraction.

Data extraction Six studies with 263 participants were analysed. Descriptive and outcome data were extracted. Main outcome measures were infections, complications other than infections, operative interventions, length of hospital stay, and mortality. The meta-analysis was performed with the random effects model.

Data synthesis Enteral nutrition was associated with a significantly lower incidence of infections (relative risk 0.45; 95% confidence interval 0.26 to 0.78, P = 0.004), reduced surgical interventions to control pancreatitis (0.48, 0.22 to 1.0, P = 0.05), and a reduced length of hospital stay (mean reduction 2.9 days, 1.6 days to 4.3 days, P < 0.001). There were no significant differences in mortality (relative risk 0.66, 0.32 to 1.37, P = 0.3) or non-infectious complications (0.61, 0.31 to 1.22, P = 0.16) between the two groups of patients.

Conclusions Enteral nutrition should be the preferred route of nutritional support in patients with acute pancreatitis.

Objective To determine the efficacy of low intensity pulsed ultrasonography for healing of fractures.

Design Systematic review of randomised controlled trials.

Data sources Electronic literature search without language restrictions of CINAHL, Embase, Medline, HealthSTAR, and the Cochrane Central Registry of Controlled Trials, from inception of the database to 10 September 2008.

Review methods Eligible studies were randomised controlled trials that enrolled patients with any kind of fracture and randomly assigned them to low intensity pulsed ultrasonography or to a control group. Two reviewers independently agreed on eligibility; three reviewers independently assessed methodological quality and extracted outcome data. All outcomes were included and meta-analyses done when possible.

Results 13 randomised trials, of which five assessed outcomes of importance to patients, were included. Moderate quality evidence from one trial found no effect of low intensity pulsed ultrasonography on functional recovery from conservatively managed fresh clavicle fractures; whereas low quality evidence from three trials suggests benefit in non-operatively managed fresh fractures (faster radiographic healing time mean 36.9%, 95% confidence interval 25.6% to 46.0%). A single trial provided moderate quality evidence suggesting no effect of low intensity pulsed ultrasonography on return to function among non-operatively treated stress fractures. Three trials provided very low quality evidence for accelerated functional improvement after distraction osteogenesis. One trial provided low quality evidence for a benefit of low intensity pulsed ultrasonography in accelerating healing of established non-unions managed with bone graft. Four trials provided low quality evidence for acceleration of healing of operatively managed fresh fractures.

Conclusion Evidence for the effect of low intensity pulsed ultrasonography on healing of fractures is moderate to very low in quality and provides conflicting results. Although overall results are promising, establishing the role of low intensity pulsed ultrasonography in the management of fractures requires large, blinded trials, directly addressing patient important outcomes such as return to function.

Background

The objective was to provide a systematic review of the effectiveness of community-level interventions to reduce maternal mortality.

Methods

We searched published papers using Medline, Embase, Cochrane library, CINAHL, BNI, CAB ABSTRACTS, IBSS, Web of Science, LILACS and African Index Medicus from inception or at least 1982 to June 2006; searched unpublished works using National Research Register website, metaRegister and the WHO International Trial Registry portal. We hand searched major references.

Selection criteria were maternity or childbearing age women, comparative study designs with concurrent controls, community-level interventions and maternal death as an outcome. We carried out study selection, data abstraction and quality assessment independently in duplicate.

Results

We found five cluster randomised controlled trials (RCT) and eight cohort studies of community-level interventions. We summarised results as odds ratios (OR) and confidence intervals (CI), combined using the Peto method for meta-analysis. Two high quality cluster RCTs, aimed at improving perinatal care practices, showed a reduction in maternal mortality reaching statistical significance (OR 0.62, 95% CI 0.39 to 0.98). Three equivalence RCTs of minimal goal-oriented versus usual antenatal care showed no difference in maternal mortality (1.09, 95% CI 0.53 to 2.25). The cohort studies were of low quality and did not contribute further evidence.

Conclusion

Community-level interventions of improved perinatal care practices can bring about a reduction in maternal mortality. This challenges the view that investment in such interventions is not worthwhile. Programmes to improve maternal mortality should be evaluated using randomised controlled techniques to generate further evidence.

Background

A meta-analysis was performed to evaluate the use of clinical pathways for hip and knee joint replacements when compared with standard medical care. The impact of clinical pathways was evaluated assessing the major outcomes of in-hospital hip and knee joint replacement processes: postoperative complications, number of patients discharged at home, length of in-hospital stay and direct costs.

Methods

Medline, Cinahl, Embase and the Cochrane Central Register of Controlled Trials were searched. The search was performed from 1975 to 2007. Each study was assessed independently by two reviewers. The assessment of methodological quality of the included studies was based on the Jadad methodological approach and on the New Castle Ottawa Scale. Data analysis abided by the guidelines set out by The Cochrane Collaboration regarding statistical methods. Meta-analyses were performed using RevMan software, version 4.2.

Results

Twenty-two studies met the study inclusion criteria and were included in the meta-analysis for a total sample of 6,316 patients. The aggregate overall results showed significantly fewer patients suffering postoperative complications in the clinical pathways group when compared with the standard care group. A shorter length of stay in the clinical pathway group was also observed and lower costs during hospital stay were associated with the use of the clinical pathways. No significant differences were found in the rates of discharge to home.

Conclusion

The results of this meta-analysis show that clinical pathways can significantly improve the quality of care even if it is not possible to conclude that the implementation of clinical pathways is a cost-effective process, because none of the included studies analysed the cost of the development and implementation of the pathways. Based on the results we assume that pathways have impact on the organisation of care if the care process is structured in a standardised way, teams critically analyse the actual organisation of the process and the multidisciplinary team is highly involved in the re-organisation. Further studies should focus on the evaluation of pathways as complex interventions to help to understand which mechanisms within the clinical pathways can really improve the quality of care. With the need for knee and hip joint replacement on the rise, the use of clinical pathways might contribute to better quality of care and cost-effectiveness.

Objective

Training midlevel providers (MLPs) to conduct surgical abortions and manage medical abortions has been proposed as a way to increase women’s access to safe abortion. This paper reviews the evidence that compares the effectiveness and safety of abortion procedures administered by MLPs versus doctors.

Methods

A systematic search was conducted of published trials and comparison studies assessing the effectiveness and/or safety of abortion provided by MLPs compared to doctors. The Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE, and Popline were searched. The primary outcomes of interest were: (1) incomplete or failed abortion; and (2) measures of safety (adverse events and complications) of abortion procedures administered by MLPs and doctors. Odds ratios (ORs) and their 95% confidence intervals (CIs) were calculated for each study. Data were synthesized in a narrative fashion.

Findings

Five studies were included in this review (n = 8539 women), comprising two randomized controlled trials (RCTs) (n = 3821) and three prospective cohort studies (n = 4718). In total, 4198 women underwent a procedure administered by an MLP, and 4341 women underwent a physician-administered procedure. Studies took place in the US, Nepal, South Africa, Vietnam, and India. Four studies used surgical abortion with maximum gestational ages ranging from 10 to 16+ weeks, while a medical abortion study had gestational ages up to 9 weeks. In RCTs, the effect estimates for incomplete or failed abortion for procedures performed by MLPs compared with doctors were OR = 2.00 (95% CI 0.85–4.68) for surgical abortion, and OR = 0.69 (95% CI 0.34–1.37) for medical abortion. Complications were rare among both provider types (1.2%–3.1%; OR = 1.80, 95% CI 0.83–3.90 for surgical abortions), and no deaths were reported.

Conclusion

There were no statistical differences in incomplete abortion and complications for first trimester surgical and medical abortion up to 9 weeks performed by MLPs compared with physicians. Further studies are required to establish more precise effect estimates.

Introduction

Patients undergoing coronary revascularization often require inotropic support that has been associated with an increased risk for death and morbidity. The purpose of this study was to evaluate the effect of levosimendan versus control on survival after coronary revascularization.

Methods

A systemic review and meta-analysis of the literature was carried out on published randomized controlled clinical trials that investigated the efficacy of levosimendan compared to other therapy in patients having coronary revascularisaion. The databases searched were Pubmed, EMBASE, the Cochrane Registry of Clinical Trials and the metaRegister of Controlled Trials. Studies that compared levosimendan to any other therapy for coronary revascularisation in adult humans and reported at least one outcome of interest were considered for inclusion. Both percutaneous coronary intervention and cardiac surgery were included. Data extraction was performed independently by two reviewers using predefined criteria. Relevant outcomes included mortality, cardiac index, cardiac enzymes, length of stay and post-procedural atrial fibrillation.

Results

The meta-analysis included 729 patients from 17 studies. Levosimendan was associated with a mortality reduction after coronary revascularization, (19/386 in the levosimendan group vs 39/343 in the control arm) odds ratio (OR) 0.40 (95% confidence interval (CI) 0.21 to 0.76, P for overall effect 0.005, P for heterogeneity = 0.33, I2 = 12% with a total of 729 patients. Levosimendan also had a favourable effect on cardiac index (standardised mean difference 1.63, 95% CI 1.43 to 1.83, P for overall effect < 0.00001), length of intensive care stay (random effects model, mean difference - 26.18 hours 95% CI 46.20 to 6.16, P for heterogeneity < 0.00001, I2 = 95%, P for overall effect P = 0.01), reductions in the rate of atrial fibrillation (OR 0.54, 95% CI 0.36 to 0.82, P for effect = 0.004, P for heterogeneity 0.84, I2 = 0% for 465 patients) and troponin I levels group (mean difference -1.59, 95% CI 1.78 to 1.40, P for overall effect < 0.00001, P for heterogeneity < 0.00001, I2 = 95%). Limitations of this analysis are discussed.

Conclusions

Levosimendan is associated with a significant improvement in mortality after coronary revascularization. There are also improvements in several secondary endpoints. A suitably powered randomised controlled trial is required to confirm these findings and to address the unresolved questions about the timing and dosing of levosimendan.

Objectives: To describe doctors' emotional reactions to the recent death of an “average” patient and to explore the effects of level of training on doctors' reactions.

Design: Cross sectional study using quantitative and qualitative data.

Setting: Two academic teaching hospitals in the United States.

Participants: 188 doctors (attending physicians (equivalent to UK consultants), residents (equivalent to UK senior house officers), and interns (equivalent to UK junior house officers)) who cared for 68 patients who died in the hospital.

Main outcome measures: Doctors' experiences in providing care, their emotional reactions to the patient's death, and their use of coping and social resources to manage their emotions.

Results: Most doctors (139/188, 74%) reported satisfying experiences in caring for a dying patient. Doctors reported moderate levels of emotional impact (mean 4.7 (SD 2.4) on a 0-10 scale) from the death. Women and those doctors who had cared for the patient for a longer time experienced stronger emotional reactions. Level of training was not related to emotional reactions, but interns reported needing significantly more emotional support than attending physicians. Although most junior doctors discussed the patient's death with an attending physician, less than a quarter of interns and residents found senior teaching staff (attending physicians) to be the most helpful source of support.

Conclusions: Doctors who spend a longer time caring for their patients get to know them better but this also makes them more vulnerable to feelings of loss when these patients die. Medical teams may benefit from debriefing within the department to give junior doctors an opportunity to share emotional responses and reflect on the patient's death.

Objective To determine the accuracy with which a single progesterone measurement in early pregnancy discriminates between viable and non-viable pregnancy.

Design Systematic review and meta-analysis of diagnostic accuracy studies.

Data sources Medline, Embase, CINAHL, Web of Science, ProQuest, Conference Proceedings Citation Index, and the Cochrane Library from inception until April 2012, plus reference lists of relevant studies.

Study selection Studies were selected on the basis of participants (women with spontaneous pregnancy of less than 14 weeks of gestation); test (single serum progesterone measurement); outcome (viable intrauterine pregnancy, miscarriage, or ectopic pregnancy) diagnosed on the basis of combinations of pregnancy test, ultrasound scan, laparoscopy, and histological examination; design (cohort studies of test accuracy); and sufficient data being reported.

Results 26 cohort studies, including 9436 pregnant women, were included, consisting of 7 studies in women with symptoms and inconclusive ultrasound assessment and 19 studies in women with symptoms alone. Among women with symptoms and inconclusive ultrasound assessments, the progesterone test (5 studies with 1998 participants and cut-off values from 3.2 to 6 ng/mL) predicted a non-viable pregnancy with pooled sensitivity of 74.6% (95% confidence interval 50.6% to 89.4%), specificity of 98.4% (90.9% to 99.7%), positive likelihood ratio of 45 (7.1 to 289), and negative likelihood ratio of 0.26 (0.12 to 0.57). The median prevalence of a non-viable pregnancy was 73.2%, and the probability of a non-viable pregnancy was raised to 99.2% if the progesterone was low. For women with symptoms alone, the progesterone test had a higher specificity when a threshold of 10 ng/mL was used (9 studies with 4689 participants) and predicted a non-viable pregnancy with pooled sensitivity of 66.5% (53.6% to 77.4%), specificity of 96.3% (91.1% to 98.5%), positive likelihood ratio of 18 (7.2 to 45), and negative likelihood ratio of 0.35 (0.24 to 0.50). The probability of a non-viable pregnancy was raised from 62.9% to 96.8%.

Conclusion A single progesterone measurement for women in early pregnancy presenting with bleeding or pain and inconclusive ultrasound assessments can rule out a viable pregnancy.

Background

The aim of this study was to determine the - largely unexplored - extent of systematic variation in the work disability assessment by Dutch insurance physicians (IPs) of employees on long-term sick leave, and to ascertain whether this variation was associated with the individual characteristics and opinions of IPs.

Methods

In March 2008 we conducted a survey among IPs on the basis of the 'Attitude - Social norm - self-Efficacy' (ASE) model. We used the ensuing data to form latent variables for the ASE constructs. We then linked the background variables and the measured constructs for IPs (n = 199) working at regional offices (n = 27) to the work disability assessments of clients (n = 83,755) and their characteristics. These assessments were carried out between July 2003 and April 2008. We performed multilevel regression analysis on three important assessment outcomes: No Sustainable Capacity or Restrictions for Working Hours (binominal), Functional Incapacity Score (scale 0-6) and Maximum Work Disability Class (binominal). We calculated Intra Class Correlations (ICCs) at IP level and office level and explained variances (R2) for the three outcomes. A higher ICC reflects stronger systematic variation.

Results

The ICCs at IP level were approximately 6% for No Sustainable Capacity or Restrictions for Working Hours and Maximum Work Disability Class and 12% for Functional Incapacity Score. Background IP variables and the measured ASE constructs for physicians contributed very little to the variation - at most 1%. The ICCs at office level ranged from 0% to around 1%. The R2 was 11% for No Sustainable Capacity or Restrictions for Working Hours, 19% for Functional Incapacity Score and 37% for Maximum Work Disability Class.

Conclusion

Our study uncovered small to moderate systematic variations in the outcome of disability assessments in the Netherlands. However, the individual characteristics and opinions of insurance physicians have very little impact on these variations. Our findings provided no indications of other reasons for these variations. They may be related to different work routines or to different views on the workload of a 'normal' employee. If so, they could be reduced by well-developed and comprehensively implemented guidelines. Therefore, further research is needed.

Background

Previous meta-analyses of treatments for pulmonary arterial hypertension (PAH) have not shown mortality benefit from any individual class of medication.

Methods

MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from inception through November 2009 for randomized trials that evaluated any pharmacotherapy in the treatment of PAH. Reference lists from included articles and recent review articles were also searched. Analysis included randomized placebo controlled trials of at least eight weeks duration and studies comparing intravenous medication to an unblinded control group.

Results

1541 unique studies were identified and twenty-four articles with 3758 patients were included in the meta-analysis. Studies were reviewed and data extracted regarding study characteristics and outcomes. Data was pooled for three classes of medication: prostanoids, endothelin-receptor antagonists (ERAs), and phosphodiesterase type 5 (PDE5) inhibitors. Pooled relative risks (RRs) and 95% confidence intervals (CIs) were calculated for mortality, 6-minute walk distance, dyspnea scores, hemodynamic parameters, and adverse effects. Mortality in the control arms was a combined 4.2% over the mean study length of 14.9 weeks. There was significant mortality benefit with prostanoid treatment (RR 0.49, CI 0.29 to 0.82), particularly comparing intravenous agents to control (RR 0.30, CI 0.14 to 0.63). Mortality benefit was not observed for ERAs (RR 0.58, CI 0.21 to 1.60) or PDE5 inhibitors (RR 0.30, CI 0.08 to 1.08). All three classes of medication improved other clinical and hemodynamic endpoints. Adverse effects that were increased in treatment arms include jaw pain, diarrhea, peripheral edema, headache, and nausea in prostanoids; and visual disturbance, dyspepsia, flushing, headache, and limb pain in PDE5 inhibitors. No adverse events were significantly associated with ERA treatment.

Conclusions

Treatment of PAH with prostanoids reduces mortality and improves multiple other clinical and hemodynamic outcomes. ERAs and PDE5 inhibitors improve clinical and hemodynamic outcomes, but have no proven effect on mortality. The long-term effects of all PAH treatment requires further study.