Showing papers in "Cochrane Database of Systematic Reviews in 2007"

Organised inpatient (stroke unit) care for stroke

Abstract: BACKGROUND Organised stroke unit care is provided by multidisciplinary teams that exclusively manage stroke patients in a dedicated ward (stroke, acute, rehabilitation, comprehensive), with a mobile stroke team or within a generic disability service (mixed rehabilitation ward). OBJECTIVES To assess the effect of stroke unit care compared with alternative forms of care for patients following a stroke. SEARCH STRATEGY We searched the Cochrane Stroke Group trials register (last searched April 2006), the reference lists of relevant articles, and contacted researchers in the field. SELECTION CRITERIA Randomised and prospective controlled clinical trials comparing organised inpatient stroke unit care with an alternative service. DATA COLLECTION AND ANALYSIS Two review authors initially assessed eligibility and trial quality. Descriptive details and trial data were then checked with the co-ordinators of the original trials. MAIN RESULTS Thirty-one trials, involving 6936 participants, compared stroke unit care with an alternative service; more organised care was consistently associated with improved outcomes. Twenty-six trials (5592 participants) compared stroke unit care with general wards. Stroke unit care showed reductions in the odds of death recorded at final (median one year) follow up (odds ratio (OR) 0.86; 95% confidence interval (CI) 0.76 to 0.98; P = 0.02), the odds of death or institutionalised care (OR 0.82; 95% CI 0.73 to 0.92; P = 0.0006) and death or dependency (OR 0.82; 95% CI 0.73 to 0.92; P = 0.001). Sensitivity analyses indicated that the observed benefits remained when the analysis was restricted to trials that used formal randomisation procedures with blinded outcome assessment. Outcomes were independent of patient age, sex or stroke severity, but appeared to be better in stroke units based in a discrete ward. There was no indication that organised stroke unit care resulted in a longer hospital stay. AUTHORS' CONCLUSIONS Stroke patients who receive organised inpatient care in a stroke unit are more likely to be alive, independent, and living at home one year after the stroke. The benefits were most apparent in units based in a discrete ward. No systematic increase was observed in the length of inpatient stay.

Effectiveness of brief alcohol interventions in primary care populations

Abstract: Excessive drinking contributes significantly to social problems, physical and psychological illness, injury and death Hidden effects include increased levels of violence, accidents and suicide Most alcohol-related harm is caused by excessive drinkers whose consumption exceeds recommended drinking levels, not the drinkers with severe alcohol dependency problems One way to reduce consumption levels in a community may be to provide a brief intervention in primary care over one to four sessions This is provided by healthcare workers such as general physicians, nurses or psychologists In general practice, patients are routinely asked about alcohol consumption during registration, general health checks and as part of health screening (using a questionnaire) They tend not to be seeking help for alcohol problems when presenting The intervention they are offered includes feedback on alcohol use and harms, identification of high risk situations for drinking and coping strategies, increased motivation and the development of a personal plan to reduce drinking It takes place within the time-frame of a standard consultation, 5 to 15 minutes for a general physician, longer for a nurseA total of 29 controlled trials from various countries were identified, in general practice (24 trials) or an emergency setting (five trials) Participants drank an average of 306 grams of alcohol (over 30 standard drinks) per week on entry to the trial Over 7000 participants with a mean age of 43 years were randomised to receive a brief intervention or a control intervention, including assessment only After one year or more, people who received the brief intervention drank less alcohol than people in the control group (average difference 38 grams/week, range 23 to 54 grams) For men (some 70% of participants), the benefit of brief intervention was a difference of 57 grams/week, range 25 to 89 grams (six trials) The benefit was not clear for women The benefits of brief intervention were similar in the normal clinical setting and in research settings with greater resources Longer counselling had little additional benefit

Educational outreach visits: effects on professional practice and health care outcomes

Abstract: Background Educational outreach visits (EOVs) have been identified as an intervention that may improve the practice of healthcare professionals. This type of face-to-face visit has been referred to as university-based educational detailing, academic detailing, and educational visiting. Objectives To assess the effects of EOVs on health professional practice or patient outcomes. Search methods For this update, we searched the Cochrane EPOC register to March 2007. In the original review, we searched multiple bibliographic databases including MEDLINE and CINAHL. Selection criteria Randomised trials of EOVs that reported an objective measure of professional performance or healthcare outcomes. An EOV was defined as a personal visit by a trained person to healthcare professionals in their own settings. Data collection and analysis Two reviewers independently extracted data and assessed study quality. We used bubble plots and box plots to visually inspect the data. We conducted both quantitative and qualitative analyses. We used meta-regression to examine potential sources of heterogeneity determined a priori. We hypothesised eight factors to explain variation across effect estimates. In our primary visual and statistical analyses, we included only studies with dichotomous outcomes, with baseline data and with low or moderate risk of bias, in which the intervention included an EOV and was compared to no intervention. Main results We included 69 studies involving more than 15,000 health professionals. Twenty-eight studies (34 comparisons) contributed to the calculation of the median and interquartile range for the main comparison. The median adjusted risk difference (RD) in compliance with desired practice was 5.6% (interquartile range 3.0% to 9.0%). The adjusted RDs were highly consistent for prescribing (median 4.8%, interquartile range 3.0% to 6.5% for 17 comparisons), but varied for other types of professional performance (median 6.0%, interquartile range 3.6% to 16.0% for 17 comparisons). Meta-regression was limited by the large number of potential explanatory factors (eight) with only 31 comparisons, and did not provide any compelling explanations for the observed variation in adjusted RDs. There were 18 comparisons with continuous outcomes, with a median adjusted relative improvement of 21% (interquartile range 11% to 41%). There were eight trials (12 comparisons) in which the intervention included an EOV and was compared to another type of intervention, usually audit and feedback. Interventions that included EOVs appeared to be slightly superior to audit and feedback. Only six studies evaluated different types of visits in head-to-head comparisons. When individual visits were compared to group visits (three trials), the results were mixed. Authors' conclusions EOVs alone or when combined with other interventions have effects on prescribing that are relatively consistent and small, but potentially important. Their effects on other types of professional performance vary from small to modest improvements, and it is not possible from this review to explain that variation.

Full publication of results initially presented in abstracts

Abstract: BACKGROUND: Abstracts of presentations at scientific meetings are usually available only in conference proceedings If subsequent full publication of abstract results is based on the magnitude or direction of study results, publication bias may result Publication bias, in turn, creates problems for those conducting systematic reviews or relying on the published literature for evidence OBJECTIVES: To determine the rate at which abstract results are subsequently published in full, and the time between meeting presentation and full publication To assess the association between study characteristics and full publication SEARCH STRATEGY: We searched MEDLINE, EMBASE, The Cochrane Library, Science Citation Index, reference lists, and author files Date of most recent search: June 2003 SELECTION CRITERIA: We included all reports that examined the subsequent full publication rate of biomedical results initially presented as abstracts or in summary form Follow-up of abstracts had to be at least two years DATA COLLECTION AND ANALYSIS: Two reviewers extracted data We calculated the weighted mean full publication rate and time to full publication Dichotomous variables were analyzed using relative risk and random effects models We assessed time to publication using Kaplan-Meier survival analyses MAIN RESULTS: Combining data from 79 reports (29,729 abstracts) resulted in a weighted mean full publication rate of 445% (95% confidence interval (CI) 439 to 451) Survival analyses resulted in an estimated publication rate at 9 years of 526% for all studies, 631% for randomized or controlled clinical trials, and 493% for other types of study designs'Positive' results defined as any 'significant' result showed an association with full publication (RR = 130; CI 114 to 147), as did 'positive' results defined as a result favoring the experimental treatment (RR =117; CI 102 to 135), and 'positive' results emanating from randomized or controlled clinical trials (RR = 118, CI 107 to 130)Other factors associated with full publication include oral presentation (RR = 128; CI 109 to 149); acceptance for meeting presentation (RR = 178; CI 150 to 212); randomized trial study design (RR = 124; CI 114 to 136); and basic research (RR = 079; CI 070 to 089) Higher quality of abstracts describing randomized or controlled clinical trials was also associated with full publication (RR = 130, CI 100 to 171) AUTHORS' CONCLUSIONS: Only 63% of results from abstracts describing randomized or controlled clinical trials are published in full 'Positive' results were more frequently published than not 'positive' results

Antidepressants for neuropathic pain

Abstract: Background This is an updated version of the original Cochrane review published in Issue 3, 2005 of The Cochrane Library . For many years antidepressant drugs have been used to manage neuropathic pain, and are often the first choice treatment. It is not clear, however, which antidepressant is more effective, what role the newer antidepressants can play in treating neuropathic pain, and what adverse effects are experienced by patients. Objectives To determine the analgesic effectiveness and safety of antidepressant drugs in neuropathic pain. Search methods Randomised controlled trials (RCTs) of antidepressants in neuropathic pain were identified in MEDLINE (1966 to Oct 2005); EMBASE (1980 to Oct 2005); the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, Issue 3, 2005; and the Cochrane Pain, Palliative and Supportive Care Trials Register (May 2002). Additional reports were identified from the reference list of the retrieved papers, and by contacting investigators. Selection criteria RCTs reporting the analgesic effects of antidepressant drugs in adult patients, with subjective assessment of pain of neuropathic origin. Studies that included patients with chronic headache and migraine were excluded. Data collection and analysis Two review authors agreed the included studies, extracted data, and assessed methodological quality independently. In this update a total of sixty one trials of 20 antidepressants were considered eligible (3293 participants) for inclusion (including 11 additional studies (778 participants)) Relative Risk (RR) and Number-Needed-to-Treat (NNTs) were calculated from dichotomous data for effectiveness and adverse effects. Main results Sixty one RCTs were included in total. Tricyclic antidepressants (TCAs) are effective and have an NNT of 3.6 (95% CI 3 to 4.5) RR 2.1 (95% CI 1.8 to 2.5) for the achievement of at least moderate pain relief. There is limited evidence for the effectiveness of the newer SSRIs but no studies of SNRIs were found. Venlafaxine (three studies) has an NNT of 3.1 (95% CI 2.2 to 5.1) RR 2.2 (95% CI 1.5 to 3.1). There were insufficient data to assess effectiveness for other antidepressants such as St Johns Wort and L-tryptophan. For diabetic neuropathy the NNT for effectiveness was 1.3 (95% CI 1.2 to 1.5) RR 12.4 (95% CI 5.2 to 29.2) (five studies); for postherpetic neuralgia 2.7 (95% CI 2 to 4.1), RR 2.2 (95% CI 1.6 to 3.1) (four studies). There was evidence that TCAs are not effective in HIV-related neuropathies. The number needed to harm (NNH) for major adverse effects defined as an event leading to withdrawal from a study was 28 (95% CI 17.6 to 68.9) for amitriptyline and 16.2 (95% CI 8 to 436) for venlafaxine. The NNH for minor adverse effects was 6 (95% CI 4.2 to 10.7) for amitriptyline and 9.6 (95% CI 3.5 to 13) for venlafaxine. Authors' conclusions This update has provided additional confirmation on the effectiveness of antidepressants for neuropathic pain and has provided new information on another antidepressant - venlafaxine. There is still limited evidence for the role of SSRIs. Whether antidepressants prevent the development of neuropathic pain (pre-emptive use) is still unclear. Both TCAs and venlafaxine have NNTs of approximately three. This means that for approximately every three patients with neuropathic pain who are treated with either of these antidepressants, one will get at least moderate pain relief. There is evidence to suggest that other antidepressants may be effective but numbers of participants are insufficient to calculate robust NNTs. SSRIs are generally better tolerated by patients and more high quality studies are required.

Screening for colorectal cancer using the faecal occult blood test, hemoccult.

Abstract: Background Colorectal cancer is a leading cause of morbidity and mortality, especially in the Western world. The human and financial costs have prompted considerable research to evaluate screening tests to detect the cancer at an early curable stage. Tests that have been considered for population screening include the faecal occult blood test (FOBT), flexible sigmoidoscopy and colonoscopy. Reducing mortality from colorectal cancer (CRC) may be achieved by the introduction of population-based screening programmes. Objectives To determine whether screening for colorectal cancer using the faecal occult blood test (guaiac or immunochemical) reduces colorectal cancer mortality and to consider the benefits and harms of screening. Search methods Published and unpublished data for this review were identified by: Reviewing studies included in the previous Cochrane review; Searching several electronic databases (Cochrane Library, Medline, Embase, CINAHL, PsychInfo, Amed, SIGLE, HMIC); and Writing to the principal investigators of potentially eligible trials. Selection criteria We included all randomised trials of screening for colorectal cancer that compared faecal occult blood test (guaiac or immunochemical) on more than one occasion with no screening and reported colorectal cancer mortality. Data collection and analysis Data from the eligible trials were independently extracted by two reviewers. The primary data analysis was performed using the group participants were originally randomised to ('intention to screen'), whether or not they attended screening; a secondary analysis adjusted for non-attendance. We calculated the relative risks and risk differences for each trial, and then overall, using fixed and random effects models (including testing for heterogeneity of effects). We identified nine articles concerning four randomised controlled trials and two controlled trials involving over 320,000 participants with follow-up ranging from 8 to 18 years. Main results Combined results from the 4 eligible randomised controlled trials shows that participants allocated to FOBT screening had a statistically significant 16% reduction in the relative risk of colorectal cancer mortality (RR 0.84; CI: 0.78-0.90). In the 3 studies that used biennial screening (Funen, Minnesota, Nottingham) there was a 15% relative risk reduction (RR 0.85, CI: 0.78-0.92) in colorectal cancer mortality. When adjusted for mean screening attendance in the individual studies, there was a 25% relative risk reduction (RR 0.75, CI: 0.66 - 0.84) for those attending at least one round of screening using the faecal occult blood test. Authors' conclusions Benefits of screening include a modest reduction in colorectal cancer mortality, a possible reduction in cancer incidence through the detection and removal of colorectal adenomas, and potentially, the less invasive surgery that earlier treatment of colorectal cancers may involve. Harmful effects of screening include the psycho-social consequences of receiving a false-positive result, the potentially significant complications of colonoscopy or a false-negative result, the possibility of overdiagnosis (leading to unnecessary investigations or treatment) and the complications associated with treatment.

Antiplatelet agents for preventing pre‐eclampsia and its complications

Abstract: Background Pre-eclampsia is associated with deficient intravascular production of prostacyclin, a vasodilator, and excessive production of thromboxane, a vasoconstrictor and stimulant of platelet aggregation. These observations led to the hypotheses that antiplatelet agents, low-dose aspirin in particular, might prevent or delay development of pre-eclampsia. Objectives To assess the effectiveness and safety of antiplatelet agents for women at risk of developing pre-eclampsia. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (July 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2005, Issue 1), EMBASE (1994 to November 2005) and handsearched congress proceedings of the International and European Societies for the Study of Hypertension in Pregnancy. We updated the search of the Cochrane Pregnancy and Childbirth Group's Trials Register on 31 May 2010 and added the results to the awaiting classification section Selection criteria All randomised trials comparing antiplatelet agents with either placebo or no antiplatelet agent were included. Quasi-random studies were excluded. Participants were pregnant women at risk of developing pre-eclampsia. Interventions were any comparisons of an antiplatelet agent (such as low-dose aspirin or dipyridamole) with either placebo or no antiplatelet. Data collection and analysis Two authors assessed trials for inclusion and extracted data independently. Main results Fifty-nine trials (37,560 women) are included. There is a 17% reduction in the risk of pre-eclampsia associated with the use of antiplatelet agents ((46 trials, 32,891 women, relative risk (RR) 0.83, 95% confidence interval (CI) 0.77 to 0.89), number needed to treat (NNT) 72 (52, 119)). Although there is no statistical difference in RR based on maternal risk, there is a significant increase in the absolute risk reduction of pre-eclampsia for high risk (risk difference (RD) -5.2% (-7.5, -2.9), NNT 19 (13, 34)) compared with moderate risk women (RD -0.84 (-1.37, -0.3), NNT 119 (73, 333)). Antiplatelets were associated with an 8% reduction in the relative risk of preterm birth (29 trials, 31,151 women, RR 0.92, 95% CI 0.88 to 0.97); NNT 72 (52, 119)), a 14% reduction in fetal or neonatal deaths (40 trials, 33,098 women, RR 0.86, 95% CI 0.76 to 0.98); NNT 243 (131, 1,666) and a 10% reduction in small-for-gestational age babies (36 trials, 23,638 women, RR 0.90, 95% CI0.83 to 0.98). There were no statistically significant differences between treatment and control groups for any other outcomes. Authors' conclusions Antiplatelet agents, largely low-dose aspirin, have moderate benefits when used for prevention of pre-eclampsia and its consequences. Further information is required to assess which women are most likely to benefit, when treatment is best started, and at what dose. [Note: The 16 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]

Allergen injection immunotherapy for seasonal allergic rhinitis

Abstract: Background Allergic rhinitis is the most common of the allergic diseases. Despite improved understanding of the pathophysiology of allergic rhinitis and advances in its pharmacological treatment, its prevalence has increased worldwide. For patients whose symptoms remain uncontrolled despite medical treatment, allergen injection immunotherapy is advised. An allergen-based treatment may reduce symptoms, the need for medication and modify the natural course of this disease. Objectives To evaluate the efficacy and safety of subcutaneous specific allergen immunotherapy, compared with placebo, for reducing symptoms and medication requirements in seasonal allergic rhinitis patients. Search methods We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1 2006), MEDLINE (1950 to 2006), EMBASE (1974 to 2006), Pre-MEDLINE, KOREAMED, INDMED, LILACS, PAKMEDINET, Scisearch, mRCT and the National Research Register. The date of the last search was February 2006. Selection criteria All studies identified by the searches were assessed to identify randomised controlled trials involving participants with symptoms of seasonal allergic rhinitis and proven allergen sensitivity, treated with subcutaneous allergen specific immunotherapy or corresponding placebo. Data collection and analysis Two independent authors identified all studies reporting double-blind, placebo controlled randomised trials of specific immunotherapy in patients with seasonal allergic rhinitis due to tree, grass or weed pollens. Two authors independently performed quality assessment of studies. Data from identified studies were abstracted onto a standard extraction sheet and subsequently entered into RevMan 4.2.8. Analysis was performed using the Standardised Mean Difference (SMD) method and a random-effects model; P values < 0.05 were considered statistically significant. The primary outcome measures were symptom scores, medication use, quality of life and adverse events. Main results We retrieved 1111 publications of which 51 satisfied our inclusion criteria. In total there were 2871 participants (1645 active, 1226 placebo), each receiving on average 18 injections. Duration of immunotherapy varied from three days to three years. Symptom score data from 15 trials were suitable for meta-analysis and showed an overall reduction in the immunotherapy group (SMD -0.73 (95% CI -0.97 to -0.50, P < 0.00001)). Medication score data from 13 trials showed an overall reduction in the immunotherapy group (SMD of -0.57 (95% CI -0.82 to -0.33, p<0.00001)). Clinical interpretation of the effect size is difficult. Adrenaline was given in 0.13% (19 of 14085 injections) of those on active treatment and in 0.01% (1 of 8278 injections) of the placebo group for treatment of adverse events. There were no fatalities. Authors' conclusions This review has shown that specific allergen injection immunotherapy in suitably selected patients with seasonal allergic rhinitis results in a significant reduction in symptom scores and medication use. Injection immunotherapy has a known and relatively low risk of severe adverse events. We found no long-term consequences from adverse events.

Exercise for treating fibromyalgia syndrome.

Abstract: Background Fibromyalgia (FM) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment. This is an update of a review published in Issue 2, 2002. Objectives The primary objective of this systematic review was to evaluate the effects of exercise training including cardiorespiratory (aerobic), muscle strengthening, and/or flexibility exercise on global well-being, selected signs and symptoms, and physical function in individuals with FM. Search methods We searched MEDLINE, EMBASE, CINAHL, SportDiscus, PubMed, PEDro, and the Cochrane Central Register for Controlled Trials (CENTRAL, Issue 3, 2005) up to and including July 2005. We also reviewed reference lists from reviews and meta-analyses of treatment studies. Selection criteria Randomized trials that were selected focused on cardiorespiratory endurance, muscle strength and/or flexibility as treatment for FM. Data collection and analysis Two of four reviewers independently extracted data for each study. All discrepancies were rechecked and consensus was achieved by discussion. Methodological quality was assessed by two instruments: the van Tulder and the Jadad methodological quality criteria. We used the American College of Sport Medicine (ACSM) guidelines to evaluate whether interventions had provided a training stimulus that would effect changes in physical fitness. Due to significant clinical heterogeneity among the studies we were only able to meta-analyze six aerobic-only studies and two strength-only studies. Main results There were a total of 2276 subjects across the 34 included studies; 1264 subjects were assigned to exercise interventions. The 34 studies comprised 47 interventions that included exercise. Effects of several disparate interventions on global well-being, selected FM signs and symptoms, and physical function in individuals with FM were summarized using standardized mean differences (SMD). There is moderate quality evidence that aerobic-only exercise training at recommended intensity levels has positive effects global well-being (SMD 0.49, 95% CI: 0.23 to 0.75) and physical function (SMD 0.66, 95% CI: 0.41 to 0.92) and possibly on pain (SMD 0.65, 95% CI: -0.09 to 1.39) and tender points (SMD 0.23, 95% CI: -0.18 to 0.65). Strength and flexibility remain under-evaluated. Authors' conclusions There is 'gold' level evidence (www.cochranemsk.org) that supervised aerobic exercise training has beneficial effects on physical capacity and FM symptoms. Strength training may also have benefits on some FM symptoms. Further studies on muscle strengthening and flexibility are needed. Research on the long-term benefit of exercise for FM is needed.

Calcium antagonists for aneurysmal subarachnoid haemorrhage

Abstract: Background Secondary ischaemia is a frequent cause of poor outcome in patients with subarachnoid haemorrhage (SAH). Its pathogenesis has been incompletely elucidated, but vasospasm probably is a contributing factor. Experimental studies have suggested that calcium antagonists can prevent or reverse vasospasm and have neuroprotective properties. Objectives To determine whether calcium antagonists improve outcome in patients with aneurysmal SAH. Search methods We searched the Cochrane Stroke Group Trials Register (last searched April 2006), MEDLINE (1966 to March 2006) and EMBASE (1980 to March 2006). We handsearched two Russian journals (1990 to 2003), and contacted trialists and pharmaceutical companies in 1995 and 1996. Selection criteria Randomised controlled trials comparing calcium antagonists with control, or a second calcium antagonist (magnesium sulphate) versus control in addition to another calcium antagonist (nimodipine) in both the intervention and control groups. Data collection and analysis Two review authors independently extracted the data and assessed trial quality. Trialists were contacted to obtain missing information. Main results Sixteen trials, involving 3361 patients, were included in the review; three of the studies were of magnesium sulphate in addition to nimodipine. Overall, calcium antagonists reduced the risk of poor outcome: the relative risk (RR) was 0.81 (95% confidence interval (CI) 0.72 to 0.92); the corresponding number of patients needed to treat was 19 (95% CI 1 to 51). For oral nimodipine alone the RR was 0.67 (95% CI 0.55 to 0.81), for other calcium antagonists or intravenous administration of nimodipine the results were not statistically significant. Calcium antagonists reduced the occurrence of secondary ischaemia and showed a favourable trend for case fatality. For magnesium in addition to standard treatment with nimodipine, the RR was 0.75 (95% CI 0.57 to 1.00) for a poor outcome and 0.66 (95% CI 0.45 to 0.96) for clinical signs of secondary ischaemia. Authors' conclusions Calcium antagonists reduce the risk of poor outcome and secondary ischaemia after aneurysmal SAH. The results for 'poor outcome' depend largely on a single large trial of oral nimodipine; the evidence for other calcium antagonists is inconclusive. The evidence for nimodipine is not beyond all doubt, but given the potential benefits and modest risks of this treatment, oral nimodipine is currently indicated in patients with aneurysmal SAH. Intravenous administration of calcium antagonists cannot be recommended for routine practice on the basis of the present evidence. Magnesium sulphate is a promising agent but more evidence is needed before definite conclusions can be drawn.

Self‐management education programmes by lay leaders for people with chronic conditions

Abstract: Lay-led self-management programmes are becoming widespread in the attempt to promote self-care for people with chronic conditions. Objectives To assess systematically the effectiveness of lay-led self-management programmes for people with chronic conditions. Randomised controlled trials (RCTs) comparing structured lay-led self-management education programmes for chronic conditions against no intervention or clinician-led programmes were used. We included seventeen trials involving 7442 participants. The interventions shared similar structures and components but studies showed heterogeneity in conditions studied, outcomes collected and effects. There were no studies of children and adolescents, only one study provided data on outcomes beyond six months, and only two studies reported clinical outcomes. Primary outcomes Health status: There was a small, statistically-significant reduction in: pain (11 studies, SMD -0.10 (95% confidence interval (CI) -0.17 to -0.04)); disability (8 studies, SMD -0.15 (95% CI -0.25 to -0.05); and fatigue (7 studies, SMD -0.16 (95% CI -0.23 to -0.09); and small, statistically-significant improvement in depression (6 studies, SMD -0.16 95% CI -0.24 to -0.07). There was a small (but not statistically- or clinically-significant) improvement in psychological well-being (5 studies; SMD -0.12 (95% CI -0.33 to 0.09)); but no difference between groups for health-related quality of life (3 studies; WMD -0.03 (95% CI -0.09 to 0.02). Six studies showed a statistically-significant improvement in self-rated general health (WMD -0.20 (95% CI -0.31 to -0.10). Health behaviours: 7 studies showed a small, statistically-significant increase in self-reported aerobic exercise (SMD -0.20 (95% CI -0.27 to -0.12)) and a moderate increase in cognitive symptom management (4 studies, WMD -0.55 ( 95% CI -0.85 to -0.26)). Healthcare use: There were no statistically-significant differences between groups in physician or general practitioner attendance (9 studies; SMD -0.03 (95% CI -0.09 to 0.04)). There were also no statistically-significant differences between groups for days/nights spent in hospital (6 studies; WMD -0.32 (95% CI -0.71 to 0.07)). Self-efficacy: (confidence to manage condition) showed a small statistically-significant improvement (10 studies): SMD -0.30, 95% CI -0.41 to -0.19. No adverse events were reported in any of the studies.

Early surfactant administration with brief ventilation vs. selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome.

Abstract: Background Both prophylactic and early surfactant replacement therapy reduce mortality and pulmonary complications in ventilated infants with respiratory distress syndrome (RDS) compared with later selective surfactant administration. However, continued post-surfactant intubation and ventilation are risk factors for bronchopulmonary dysplasia (BPD). The purpose of this review was to compare outcomes between two strategies of surfactant administration in infants with RDS; prophylactic or early surfactant administration followed by prompt extubation, compared with later, selective use of surfactant followed by continued mechanical ventilation. Objectives To compare two treatment strategies in preterm infants with or at risk for RDS: early surfactant administration with brief mechanical ventilation (less than one hour) followed by extubation vs. later selective surfactant administration, continued mechanical ventilation, and extubation from low respiratory support. Two populations of infants receiving early surfactant were considered: spontaneously breathing infants with signs of RDS (who receive surfactant administration during evolution of RDS prior to requiring intubation for respiratory failure) and infants at high risk for RDS (who receive prophylactic surfactant administration within 15 minutes after birth). Search strategy Searches were made of the Oxford Database of Perinatal Trials, MEDLINE (1966 - December 2006), CINAHL (1982 to December Week 2, 2006), EMBASE (1980 - December 2006), Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2006), Pediatric Research (1990 - 2006), abstracts, expert informants and hand searching. No language restrictions were applied. Selection criteria Randomized or quasi-randomized controlled clinical trials comparing early surfactant administration with planned brief mechanical ventilation (less than one hour) followed by extubation vs. selective surfactant administration continued mechanical ventilation, and extubation from low respiratory support. Data collection and analysis Data were sought regarding effects on the incidence of mechanical ventilation (ventilation continued or initiated beyond one hour after surfactant administration), incidence of bronchopulmonary dysplasia (BPD), chronic lung disease (CLD), mortality, duration of mechanical ventilation, duration of hospitalization, duration of oxygen therapy, duration of respiratory support (including CPAP and nasal cannula), number of patients receiving surfactant, number of surfactant doses administered per patient, incidence of air leak syndromes (pulmonary interstitial emphysema, pneumothorax), patent ductus arteriosus requiring treatment, pulmonary hemorrhage, and other complications of prematurity. Stratified analysis was performed according to inspired oxygen threshold for early intubation and surfactant administration in the treatment group: inspired oxygen within lower (FiO2 ≤ 0.45) or higher (FiO2 > 0.45) range at study entry. Treatment effect was expressed as relative risk (RR) and risk difference (RD) for categorical variables, and weighted mean difference (WMD) for continuous variables. Main results Six randomized controlled clinical trials met selection criteria and were included in this review. In these studies of infants with signs and symptoms of RDS, intubation and early surfactant therapy followed by extubation to nasal CPAP (NCPAP) compared with later selective surfactant administration was associated with a lower incidence of mechanical ventilation [typical RR 0.67, 95% CI 0.57, 0.79], air leak syndromes [typical RR 0.52, 95% CI 0.28, 0.96] and BPD [typical RR 0.51, 95% CI 0.26, 0.99]. A larger proportion of infants in the early surfactant group received surfactant than in the selective surfactant group [typical RR 1.62, 95% CI 1.41, 1.86]. The number of surfactant doses per patient was significantly greater among patients randomized to the early surfactant group [WMD 0.57 doses per patient, 95% CI 0.44, 0.69]. In stratified analysis by FIO2 at study entry, a lower threshold for treatment (FIO2 ≤ 0.45) resulted in lower incidence of airleak [typical RR 0.46 and 95% CI 0.23, 0.93] and BPD [typical RR 0.43, 95% CI 0.20, 0.92]. A higher treatment threshold (FIO2 > 0.45) at study entry was associated with a higher incidence of patent ductus arteriosus requiring treatment [typical RR 2.15, 95% CI 1.09, 4.13]. Authors' conclusions Early surfactant replacement therapy with extubation to NCPAP compared with later selective surfactant replacement and continued mechanical ventilation with extubation from low ventilator support is associated with less need mechanical ventilation, lower incidence of BPD and fewer air leak syndromes. A lower treatment threshold (FIO2 ≤ 0.45) confers greater advantage in reducing the incidences of airleak syndromes and BPD; moreover a higher treatment threshold (FIO2 at study > 0.45) was associated with increased risk of PDA. These data suggest that treatment with surfactant by transient intubation using a low treatment threshold (FIO2 ≤ 0.45) is preferable to later, selective surfactant therapy by transient intubation using a higher threshold for study entry (FIO2 > 0.45) or at the time of respiratory failure and initiation of mechanical ventilation. Plain Language Summary Early surfactant administration with brief ventilation vs. selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome Respiratory distress syndrome (RDS) is the single most important cause of illness and death in preterm infants. Common treatments for RDS include supplemental oxygen and nasal continuous positive airway pressure (NCPAP). For severe RDS, surfactant administration during mechanical ventilation is used. Although treating RDS with surfactant improves clinical outcomes, mechanical ventilation can cause lung injury in preterm infants with RDS and contribute to the development of chronic lung disease (oxygen requirements at 36 weeks) and bronchopulmonary dysplasia (requirement for supplementary oxygen at 28 days, BPD). An important question is whether giving early surfactant with planned brief mechanical ventilation followed by prompt extubation (to NCPAP) is better than selectively giving surfactant when RDS has worsened causing respiratory insufficiency necessitating mechanical ventilation. The review authors identified six randomized trials reported between 1994 and 2006 that met the selection criteria for this review. A strategy of early surfactant administration with extubation to NCPAP was associated with significant reductions in the need for mechanical ventilation, fewer air leak syndromes (such as pneumothorax) and lower incidence of BPD compared with a strategy of later selective surfactant administration and continued mechanical ventilation in infants with RDS. The findings suggest that a lower treatment threshold (oxygen requirement 0.45). An early surfactant therapy strategy results in a greater number of infants receiving surfactant and so more infants being exposed to the potential risks of intubation and surfactant administration. Although no complications of surfactant administration were reported in the studies reviewed, infants treated with an early surfactant therapy strategy tended to have a higher prevalence of patent ductus arteriosus (PDA). Two trials were terminated prior to achieving the targeted enrollment when the need for mechanical ventilation was found to be significantly different between groups at a scheduled interim analysis. Two other trials experienced slow enrollment leading to reduced numbers.

Self‐management education for patients with chronic obstructive pulmonary disease

Abstract: BACKGROUND: There is great interest in chronic obstructive pulmonary disease (COPD) and the associated large burden of disease. COPD is characterised by frequent day by day fluctuations, and repetitive clinical exacerbations are typical. Self-management is a term applied to educational programmes aimed at teaching skills needed to carry out medical regimens specific to the disease, guide health behaviour change, and provide emotional support for patients to control their disease and live functional lives. In COPD, the value of self-management education is not yet clear. The first Cochrane review about self-management was published in 2003. It was intended to shed light on the effectiveness of self-management programmes in COPD and the relative efficacy of their constitutive elements. No conclusions about the effectiveness of self-management could be drawn because of the large variation in outcome measures used in the limited number of included studies. This article describes the first update of this review. OBJECTIVES: The objective of this review was to assess the settings, methods and efficacy of COPD self-management education programmes on health outcomes and use of health care services. SEARCH STRATEGY: We searched the Cochrane Airways Group trial register, MEDLINE (January 1985 to January 2006), reference lists, and abstracts of medical conferences. SELECTION CRITERIA: Controlled trials (randomised and non-randomised) of self-management education in patients with COPD. Studies focusing mainly on pulmonary rehabilitation and studies without usual care as a control group were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed study quality and extracted data. Investigators were contacted for additional information. MAIN RESULTS: The reviewers included 15 group comparisons drawn from 14 trials. They assessed a broad-spectrum of interventions and health outcomes with different follow-up times. Meta-analyses could often not appropriately be performed because of heterogeneity among studies. The studies showed a significant reduction in the probability of at least one hospital admission among patients receiving self-management education compared to those receiving usual care (OR 0.64; 95% CI (0.47 to 0.89)). This translates into a one year NNT ranging from 10 (6 to 35) for patients with a 51% risk of exacerbation, to an NNT of 24 (16 to 80) for patients with a 13% risk of exacerbation. On the disease specific SGRQ, differences reached statistical significance at the 5% level on the total score (WMD -2.58; 95% CI (-5.14 to -0.02)) and impact domain (WMD -2.83; 95% CI (-5.65 to -0.02)), but these difference did not reach the clinically relevant improvement of 4 points. A small but significant reduction was detected in dyspnoea measured with the BORG-scale (WMD -0.53; 95% CI (-0.96 to -0.10)). No significant effects were found either in number of exacerbations, emergency department visits, lung function, exercise capacity, and days lost from work. Inconclusive results were observed in doctor and nurse visits, on symptoms other than dyspnoea, the use of courses of oral corticosteroids and antibiotics, and the use of rescue medication. AUTHORS' CONCLUSIONS: It is likely that self-management education is associated with a reduction in hospital admissions with no indications for detrimental effects in other outcome parameters. This would in itself already be enough reason for recommending self-management education in COPD. However, because of heterogeneity in interventions, study populations, follow-up time, and outcome measures, data are still insufficient to formulate clear recommendations regarding the form and contents of self-management education programmes in COPD. There is an evident need for more large RCTs with a long-term follow-up, before more conclusions can be drawn.

Formula milk versus donor breast milk for feeding preterm or low birth weight infants.

Abstract: Background Maternal breast milk may contain less nutrients than artificial formula milk but may confer important non-nutrient advantages for preterm or low birth weight infants. Objectives To determine the effect of feeding with formula milk compared with maternal breast milk on rate of growth and developmental outcomes in preterm or low birth weight infants. Search methods The standard search strategy of the Cochrane Neonatal Review Group was used. This included electronic searches of the Cochrane Central Register of Controlled Trials Register (CENTRAL, The Cochrane Library, Issue 3, 2007), MEDLINE (1966 - June 2007) and EMBASE (1980 - June 2007) and CINAHL (1982 to June 2007) (all accessed via OVID) and previous reviews including cross references. Selection criteria Randomised controlled trials comparing feeding with formula milk versus preterm human milk in preterm or low birth weight infants. Data collection and analysis The standard methods of the Cochrane Neonatal Review Group were used, with separate evaluation of trial quality and data extraction by two authors. Main results No eligible trials were identified. Authors' conclusions There are no data from randomised trials of formula milk versus maternal breast milk for feeding preterm or low birth weight infants. This may relate to a perceived difficulty of allocating an alternative feed to an infant whose mother wishes to feed with her own breast milk. Maternal breast milk remains the default choice of enteral nutrition because observational studies, and meta-analyses of trials comparing feeding with formula milk versus donor breast milk, suggest that feeding with breast milk has major non-nutrient advantages for preterm or low birth weight infants.

Grey literature in meta‐analyses of randomized trials of health care interventions

Abstract: BACKGROUND: The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. OBJECTIVES: To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. SEARCH STRATEGY: We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. SELECTION CRITERIA: A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. DATA COLLECTION AND ANALYSIS: Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. MAIN RESULTS: Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most common types of grey literature were abstracts (55%) and unpublished data (30%). There is limited evidence to show whether grey trials are of poorer methodological quality than published trials. AUTHORS' CONCLUSIONS: This review shows that published trials tend to be larger and show an overall greater treatment effect than grey trials. This has important implications for reviewers who need to ensure they identify grey trials, in order to minimise the risk of introducing bias into their review.

Psychosocial and psychological interventions for treating postpartum depression

Abstract: Background Epidemiological studies and meta-analyses of predictive studies have consistently demonstrated the importance of psychosocial and psychological variables as postpartum depression risk factors. While interventions based on these variables may be effective treatment strategies, theoretically they may also be used in pregnancy and the early postpartum period to prevent postpartum depression. Objectives Primary: to assess the effect of diverse psychosocial and psychological interventions compared with usual antepartum, intrapartum, or postpartum care to reduce the risk of developing postpartum depression. Secondary: to examine (1) the effectiveness of specific types of psychosocial and psychological interventions, (2) the effectiveness of professionally-based versus lay-based interventions, (3) the effectiveness of individually-based versus group-based interventions, (4) the effects of intervention onset and duration, and (5) whether interventions are more effective in women selected with specific risk factors. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2011), scanned secondary references and contacted experts in the field. We updated the search on 31 December 2012 and added the results to the awaiting classification section of the review for assessment at the next update. Selection criteria All published and unpublished randomised controlled trials of acceptable quality comparing a psychosocial or psychological intervention with usual antenatal, intrapartum, or postpartum care. Data collection and analysis Review authors and a research co-ordinator with Cochrane review experience participated in the evaluation of methodological quality and data extraction. Additional information was sought from several trial researchers. Results are presented using risk ratio (RR) for categorical data and mean difference (MD) for continuous data. Main results Twenty-eight trials, involving almost 17,000 women, contributed data to the review. Overall, women who received a psychosocial or psychological intervention were significantly less likely to develop postpartum depression compared with those receiving standard care (average RR 0.78, 95% confidence interval (CI) 0.66 to 0.93; 20 trials, 14,727 women). Several promising interventions include: (1) the provision of intensive, individualised postpartum home visits provided by public health nurses or midwives (RR 0.56, 95% CI 0.43 to 0.73; two trials, 1262 women); (2) lay (peer)-based telephone support (RR 0.54, 95% CI 0.38 to 0.77; one trial, 612 women); and (3) interpersonal psychotherapy (standardised mean difference -0.27, 95% CI -0.52 to -0.01; five trials, 366 women). Professional- and lay-based interventions were both effective in reducing the risk to develop depressive symptomatology. Individually-based interventions reduced depressive symptomatology at final assessment (RR 0.75, 95% CI 0.61 to 0.92; 14 trials, 12,914 women) as did multiple-contact interventions (RR 0.78, 95% CI 0.66 to 0.93; 16 trials, 11,850 women). Interventions that were initiated in the postpartum period also significantly reduced the risk to develop depressive symptomatology (RR 0.73, 95% CI 0.59 to 0.90; 12 trials, 12,786 women). Identifying mothers 'at-risk' assisted the prevention of postpartum depression (RR 0.66, 95% CI 0.50 to 0.88; eight trials, 1853 women). Authors' conclusions Overall, psychosocial and psychological interventions significantly reduce the number of women who develop postpartum depression. Promising interventions include the provision of intensive, professionally-based postpartum home visits, telephone-based peer support, and interpersonal psychotherapy.

Methods to increase response rates to postal questionnaires

Abstract: Background: Postal questionnaires are widely used for data collection in epidemiological studies but non-response reduces the effective sample size and can introduce bias. Finding ways to increase response rates to postal questionnaires would improve the quality of health research. Objectives: To identify effective strategies to increase response rates to postal questionnaires. Search strategy: We aimed to find all randomised controlled trials of strategies to increase response rates to postal questionnaires. We searched 14 electronic databases to February 2003 and manually searched the reference lists of relevant trials and reviews, and all issues of two journals. We contacted the authors of all trials or reviews to ask about unpublished trials. Where necessary, authors were also contacted to confirm methods of allocation used and to clarify results presented. We assessed the eligibility of each trial using pre-defined criteria. Selection criteria: Randomised controlled trials of methods to increase response rates to postal questionnaires. Data collection and analysis: We extracted data on the trial participants, the intervention, the number randomised to intervention and comparison groups and allocation concealment. For each strategy, we estimated pooled odds ratios and 95% confidence intervals in a random effects model. Evidence for selection bias was assessed using Egger's weighted regression method and Begg's rank correlation test and funnel plot. Heterogeneity among trial odds ratios was assessed using a chi-square test at a 5% significance level and the degree of inconsistency between trial results was quantified using I2. Main results: We found 372 eligible trials. The trials evaluated 98 different ways of increasing response rates to postal questionnaires and for 62 of these the combined trials included over 1,000 participants. We found substantial heterogeneity among trial results in half of the strategies. The odds of response were at least doubled using monetary incentives (odds ratio 1.99, 95% CI 1.81 to 2.18; heterogeneity p < 0.00001, I 2 =78%), recorded delivery (2.04, 1.60 to 2.61; p=0.0004, I 2 =69%), a teaser on the envelope - e.g. a comment suggesting to participants that they may benefit if they open it (3.08, 1.27 to 7.44) and a more interesting questionnaire topic (2.44, 1.99 to 3.01; p=0.74, I 2 =0%). The odds of response were substantially higher with pre-notification (1.50, 1.29 to 1.74; p < 0.00001, I 2 =90%), follow-up contact (1.44, 1.25 to 1.65; p < 0.0001, I 2 =68%), unconditional incentives (1.61, 1.27 to 2.04; p < 0.00001, I 2 =91%), shorter questionnaires (1.73, 1.47 to 2.03; p < 0.00001, I 2 =93%), providing a second copy of the questionnaire at follow-up (1.51, 1.13 to 2.00; p < 0.00001, I 2 =83%), mentioning an obligation to respond (1.61, 1.16 to 2.22; p=0.98, I 2 =0%) and university sponsorship (1.32, 1.13 to 1.54; p < 0.00001, I 2 =83%). The odds of response were also increased with non-monetary incentives (1.13, 1.07 to 1.21; p < 0.00001, I 2 =71%), personalised questionnaires (1.16, 1.07 to 1.26; p < 0.00001, I 2 =67%), use of coloured as opposed to blue or black ink (1.39, 1.16 to 1.67), use of stamped return envelopes as opposed to franked return envelopes (1.29, 1.18 to 1.42; p < 0.00001, I 2 =72%), an assurance of confidentiality (1.33, 1.24 to 1.42) and first class outward mailing (1.12, 1.02 to 1.23). The odds of response were reduced when the questionnaire included questions of a sensitive nature (0.94, 0.88 to 1.00; p=0.51, I 2 =0%), when questionnaires began with the most general questions (0.80, 0.67 to 0.96), or when participants were offered the opportunity to opt out of the study (0.76, 0.65 to 0.89; p=0.46, I 2 =0%). Authors' conclusions: Health researchers using postal questionnaires can increase response rates using the strategies shown to be effective in this systematic review. Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Screening for abdominal aortic aneurysm

Abstract: Background Abdominal aortic aneurysm (AAA) is found in 5% to 10% of men aged 65 to 79 years. The major complication is rupture which presents as a surgical emergency. The mortality after rupture is high, 80% for patients reaching hospital and 50% for those undergoing surgery for emergency repair. Currently elective surgical repair is recommended for aneurysms discovered to be larger than 5.5 cm to prevent rupture. There is interest in population screening to detect, monitor and repair abdominal aortic aneurysms before rupture. Objectives To determine the effects of screening asymptomatic individuals for AAA on mortality, subsequent treatment, quality of life and cost effectiveness of screening. Search methods The Cochrane Peripheral Vascular Diseases Group searched their Trials Register (last searched 27 July 2007) and CENTRAL (last searched 2007, Issue 3). Selection criteria Randomised controlled trials of population screening for AAA. Data collection and analysis Two authors independently assessed trials and extracted data. Main results Four studies involving 127,891 men and 9342 women were included in this review. Only one study included women. Results for men and women were analysed separately. Three to five years after screening there was no significant difference in all-cause mortality between screened and unscreened groups for men or women (men, odds ratio (OR) 0.95; 95% Confidence interval (CI) 0.85 to 1.07; for women OR 1.06; 95% CI 0.93 to 1.21). There was a significant decrease in mortality from AAA in men (OR 0.60; 95% CI 0.47 to 0.78), but not for women (OR 1.99; 95% CI 0.36 to 10.88). In this analysis mortality includes death from rupture and from emergency or elective surgery for aneurysm repair. There was also a decreased incidence of ruptured aneurysm in men (OR 0.45; 95% CI 0.21 to 0.99) but not in women (OR 1.49; 95% CI 0.25 to 8.94). There was a significant increase in surgery for AAA in men (OR 2.03; 95% CI 1.59 to 2.59). This was not reported in women. There were no data on life expectancy, complications of surgery or subjective quality of life. Authors' conclusions There is evidence of a significant reduction in mortality from AAA in men aged 65 to 79 years who undergo ultrasound screening. There is insufficient evidence to demonstrate benefit in women. The cost effectiveness may be acceptable, but needs further expert analysis. These findings need careful consideration in judging whether a co-ordinated population-based screening programme should be introduced.

Enteral nutritional therapy for induction of remission in Crohn's disease

Abstract: Background The role of enteral nutrition in Crohn's disease is controversial. Increasing research on the mechanisms by which nutritional therapy improves the clinical well being of patients with Crohn's disease has led to novel formula design and trials comparing two different forms of enteral nutrition. This meta-analysis aims to provide an update on the existing effectiveness data for both corticosteroids versus enteral nutrition and for one form of enteral nutrition versus another for inducing remission of active Crohn's disease. Objectives To evaluate the effectiveness of exclusive enteral nutrition (EN) as primary therapy to induce remission in Crohn's disease and to examine the importance of formula composition on effectiveness. Search methods Studies were selected using a computer-assisted search of the on-line bibliographic databases MEDLINE (1966-2006) and EMBASE (1984-2006), as well as the Science Citation Index on Web of Science. Additional citations were sought by manual search of references of articles retrieved from the computerized search, abstracts submitted to major gastroenterologic meetings and published in the journals: American Journal of Gastroenterology, Gut, Gastroenterology, Journal of Pediatric Gastroenterology and Nutrition, and Journal of Parenteral and Enteral Nutrition, and from the reviewers' personal files or contact with leaders in the field. Selection criteria All randomized and quasi-randomized controlled trials involving patients with active Crohn's disease defined by a clinical disease activity index were considered for review. Studies evaluating the administration of one type of enteral nutrition to one group of patients and another type of enteral nutrition or conventional corticosteroids to the other group were selected for review. Data collection and analysis Data were extracted independently by two authors and any discrepancies were resolved by rereading and discussion. For the dichotomous variable, achievement of remission, individual and pooled trial statistics were calculated as odds ratios (OR) with 95% confidence intervals (CI); both fixed and random effect models were used. The results for each analysis were tested for heterogeneity using the chi square statistic. The studies were separated into two groups: A. one form of enteral nutrition compared with another form of enteral nutrition and B. one form of enteral nutrition compared with corticosteroids. Subgroup analyses were conducted on the basis of clinical or disease criteria and formula composition. Sensitivity analyses were conducted on the basis of the inclusion of abstract publications, methodologic quality and by random or fixed effects models. Main results In part A, of the 15 included eligible trials (one abstract) comparing different formulations of EN for the treatment of active CD, 11 compared one (or more) elemental formula to a non-elemental one, three compared enteral diets of similar protein composition but different fat composition, and one compared non-elemental diets differing only in glutamine enrichment. Meta-analysis of ten trials comprising 334 patients demonstrated no difference in the efficacy of elemental versus non-elemental formulas (OR 1.10; 95% CI 0.69 to 1.75). Subgroup analyses performed to evaluate the different types of elemental and non-elemental diets (elemental, semi-elemental and polymeric) showed no statistically significant differences. Further analysis of seven trials including 209 patients treated with EN formulas of differing fat content (low fat: 20 g/1000 kCal) demonstrated no statistically significant difference in efficacy (OR 1.13; 95% CI 0.63 to 2.01). Similarly, the effect of very low fat content (< 3 g/1000 kCal) or type of fat (long chain triglycerides) were investigated, but did not demonstrate a difference in efficacy in the treatment of active CD, although a non significant trend was demonstrated favoring very low fat and very low long chain triglyceride content. This result should be interpreted with caution due to statistically significant heterogeneity and small sample size. Sensitivity analyses had no significant effects on the results. The role of specific fatty acids or disease characteristics on response to therapy could not be evaluated. In part B, eight trials (including two abstracts) comparing enteral nutrition to steroid therapy met the inclusion criteria for review. Meta-analysis of six trials that included 192 patients treated with enteral nutrition and 160 treated with steroids yielded a pooled OR of 0.33 favouring steroid therapy (95% CI 0.21 to 0.53). A sensitivity analysis including the abstracts resulted in an increase in the number of participants to 212 in the enteral nutrition group and 179 in the steroid group but the meta-analysis yielded a similar result (OR 0.36; 95% CI 0.23 to 0.56). There were inadequate data from full publications to perform further subgroup analyses by age, disease duration and disease location. Authors' conclusions Corticosteroid therapy is more effective than enteral nutrition for inducing remission of active Crohn's disease as was found in previous systematic reviews. Protein composition does not influence the effectiveness of EN in the treatment of active CD. A non significant trend favouring very low fat and/or very low long chain triglyceride content exists but larger trials are required to explore the significance of this finding.

Prophylactic nasogastric decompression after abdominal surgery

Abstract: Background Routine use of nasogastric tubes after abdominal operations is intended to hasten the return of bowel function, prevent pulmonary complications, diminish the risk of anastomotic leakage, increase patient comfort and shorten hospital stay.

Low glycaemic index or low glycaemic load diets for overweight and obesity.

Abstract: There is a lack of consensus as to the best nutritional management of obesity. We assessed the effects of low glycaemic index or glycaemic load diets in overweight or obese people. Six randomised controlled trials, involving 202 participants, were analysed. Interventions ranged from five weeks to six months duration. Participants receiving the low glycaemic index or load diet lost a mean of one kilogramme more than those on comparison diets. Lipid profile also improved more in participants receiving the low glycaemic index or load diet. No study reported adverse effects, mortality or quality of life data.

Individual or group antenatal education for childbirth or parenthood, or both

Abstract: Background Structured antenatal education programs for childbirth or parenthood, or both, are commonly recommended for pregnant women and their partners by healthcare professionals in many parts of the world. Such programs are usually offered to groups but may be offered to individuals. Objectives To assess the effects of this education on knowledge acquisition, anxiety, sense of control, pain, labour and birth support, breastfeeding, infant-care abilities, and psychological and social adjustment. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (April 2006), CINAHL (1982 to April 2006), ERIC (1984 to April 2006), EMBASE (1980 to April 2006) and PsycINFO (1988 to April 2006). We handsearched the Journal of Psychosomatic Research from 1956 to April 2006 and reviewed the reference lists of retrieved studies. We updated the search of the Cochrane Pregnancy and Childbirth Group's Trials Register on 7 July 2011 and added the results to the awaiting classification section of the review. Selection criteria Randomized controlled trials of any structured educational program provided during pregnancy by an educator to either parent that included information related to pregnancy, birth or parenthood. The educational interventions could have been provided on an individual or group basis. Educational interventions directed exclusively to either increasing breastfeeding success, knowledge of and coping skills concerning postpartum depression, improving maternal psycho-social health including anxiety, depression and self-esteem or reducing smoking were excluded. Data collection and analysis Both authors assessed trial quality and extracted data from published reports. Main results Nine trials, involving 2284 women, were included. Thirty-seven studies were excluded. Educational interventions were the focus of eight of the studies (combined n = 1009). Details of the randomization procedure, allocation concealment, and/or participant accrual or loss for these trials were not reported. No consistent results were found. Sample sizes were very small to moderate, ranging from 10 to 318. No data were reported concerning anxiety, breastfeeding success, or general social support. Knowledge acquisition, sense of control, factors related to infant-care competencies, and some labour and birth outcomes were measured. The largest of the included studies (n = 1275) examined an educational and social support intervention to increase vaginal birth after caesarean section. This high-quality study showed similar rates of vaginal birth after caesarean section in 'verbal' and 'document' groups (relative risk 1.08, 95% confidence interval 0.97 to 1.21). Authors' conclusions The effects of general antenatal education for childbirth or parenthood, or both, remain largely unknown. Individualized prenatal education directed toward avoidance of a repeat caesarean birth does not increase the rate of vaginal birth after caesarean section. [Note: the 58 citations in the awaiting classification section may alter the conclusions of the review once assessed.]

Antipsychotics for delirium

Abstract: Background Delirium occurs in up to 30% of hospitalised patients and is associated with prolonged hospital stay and increased morbidity and mortality. Recently published reports have suggested that the standard drug for delirium, haloperidol, a typical antipsychotic that may cause adverse extrapyramidal symptoms among patients, may be replaced by atypical antipsychotics such as risperidone, olanzapine or quetiapine, that are as effective as haloperidol in controlling delirium, but that have a lower incidence of extrapyramidal adverse effects. Objectives To compare the efficacy and incidence of adverse effects of haloperidol with risperidone, olanzapine, and quetiapine in the treatment of delirium. Search methods The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 7 August 2006 using the search terms: haloperidol or haldol or risperidone or risperdal* or quetiapine or seroquel* or olanzapine or zyprexa* or aminotriazole or sertindole or leponex* or zeldox* or ziprasidone. Selection criteria Types of studies included unconfounded, randomised trials with concealed allocation of subjects. For inclusion trials had to have assessed patients pre- and post-treatment. Where cross-over studies are included, only data from the first part of the study were examined. Interrupted time series were excluded. Length of trial and number of measurements did not influence the selection of trials for study. Where indicated, individual patient data were requested for further examination. Data collection and analysis Two reviewers extracted data from included trials. Data were pooled where possible, and analysed using appropriate statistical methods. Odds ratios of average differences were calculated. Only 'intention to treat' data were included. Analysis included haloperidol treated patients, compared with placebo. Main results Three studies were found that satisfied selection criteria. These studies compared haloperidol with risperidone, olanzapine, and placebo in the management of delirium and in the incidence of adverse drug reactions. Decrease in delirium scores were not significantly different comparing the effect of low dose haloperidol ( 4.5 mg per day) in one study was associated with an increased incidence of extrapyramidal adverse effects, compared with olanzapine. Low dose haloperidol decreased the severity and duration of delirium in post-operative patients, although not the incidence of delirium, compared to placebo controls in one study. There were no controlled trials comparing quetiapine with haloperidol. Authors' conclusions There is no evidence that haloperidol in low dosage has different efficacy in comparison with the atypical antipsychotics olanzapine and risperidone in the management of delirium or has a greater frequency of adverse drug effects than these drugs. High dose haloperidol was associated with a greater incidence of side effects, mainly parkinsonism, than the atypical antipsychotics. Low dose haloperidol may be effective in decreasing the degree and duration of delirium in post-operative patients, compared with placebo. These conclusions must be tempered by the observation that they are based on small studies of limited scope, and therefore will require further corroborating evidence before they can be translated into specific recommendation for the treatment of delirium.

Probiotics in infants for prevention of allergic disease and food hypersensitivity

Abstract: Background The composition of the intestinal microflora may be different in individuals with atopic eczema from those without this condition, and such differences may precede the development of eczema. Probiotics are live bacteria that colonize the gastrointestinal tract and provide a health benefit to the host. Probiotics added to infant feeds have the potential to prevent sensitisation of infants to dietary allergens. Objectives To determine the effect of probiotics given to infants for the prevention of allergic disease or food hypersensitivity. Search methods This included searches of the Cochrane Central Register of Controlled Trials (Issue 1, 2007), MEDLINE (1966 - February 2007), EMBASE, PREMEDLINE, abstracts of conference proceedings and citations of published articles, and expert informants. Selection criteria Randomised and quasi-randomised controlled trials that compare the use of a probiotic to no probiotic; or the use a specific probiotic compared to a different probiotic; or a probiotic with added prebiotic to control. Data collection and analysis Assessment of trial quality, data extraction and synthesis of data were performed using standard methods of the Cochrane Neonatal Review Group. Main results Twelve studies were eligible for inclusion. Allergic disease and / or food hypersensitivity outcomes were assessed by 6 studies enrolling 2080 infants, but outcomes for only 1549 infants were reported. Studies generally had adequate randomisation, allocation concealment and blinding of treatment. However, the findings of this review should be treated with caution due to excess losses in patient follow-up (17% to 61%). Meta-analysis of five studies reporting the outcomes of 1477 infants found a significant reduction in infant eczema (typical RR 0.82, 95% CI 0.70, 0.95). However, there was significant and substantial heterogeneity between studies. One study reported that the difference in eczema between groups persisted to 4 years age. When the analysis was restricted to studies reporting atopic eczema (confirmed by skin prick test or specific IgE), the findings were no longer significant (typical RR 0.80, 95% CI 0.62, 1.02). All studies reporting significant benefits used probiotic supplements containing L. rhamnosus and enrolled infants at high risk of allergy. No other benefits were reported for any other allergic disease or food hypersensitivity outcome. Authors' conclusions There is insufficient evidence to recommend the addition of probiotics to infant feeds for prevention of allergic disease or food hypersensitivity. Although there was a reduction in clinical eczema in infants, this effect was not consistent between studies and caution is advised in view of methodological concerns regarding included studies. Further studies are required to determine whether the findings are reproducible.

Long acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus

Abstract: Background Despite indications from epidemiological trials that higher blood glucose concentrations are associated with a higher risk for developing micro- and macrovascular complications, evidence for a beneficial effect of antihyperglycaemic therapy in patients with type 2 diabetes mellitus is conflicting. Two large studies, the United Kingdom Prospective Diabetes Study (UKPDS) and the University Group Diabetes Program (UGDP), did not find a reduction of cardiovascular endpoints through improvement of metabolic control. The theoretical benefits of newer insulin analogues might result in fewer macrovascular and microvascular events. Objectives To assess the effects of long-term treatment with long-acting insulin analogues (insulin glargine and insulin detemir) compared to NPH insulin in patients with type 2 diabetes mellitus. Search methods Studies were obtained from computerised searches of MEDLINE, EMBASE, The Cochrane Library and communication with experts in the field as well as insulin producing companies. Selection criteria Studies were included if they were randomised controlled trials in adults with diabetes mellitus type 2 and had a trial duration of at least 24 weeks. Data collection and analysis Two authors independently assessed trial quality and extracted data. Pooling of studies by means of random-effects meta-analyses was performed. Main results Six studies comparing insulin glargine to NPH (Neutral Protamine Hagedorn) insulin and two studies comparing insulin detemir to NPH insulin were identified. In these trials, 1715 patients were randomised to insulin glargine and 578 patients to insulin detemir. Duration of the included trials ranged from 24 to 52 weeks. Metabolic control, measured by glycosylated haemoglobin A1c (HbA1c) as a surrogate endpoint, and adverse effects did not differ in a clinical relevant way between treatment groups. While no statistically significant difference for severe hypoglycaemia rates was shown in any of the trials, the rate of symptomatic, overall and nocturnal hypoglycaemia was statistically significantly lower in patients treated with either insulin glargine or detemir. No evidence for a beneficial effect of long-acting analogues on patient-oriented outcomes like mortality, morbidity, quality of life or costs could be obtained. Authors' conclusions Our analysis suggests, if at all only a minor clinical benefit of treatment with long-acting insulin analogues for patients with diabetes mellitus type 2 treated with "basal" insulin regarding symptomatic nocturnal hypoglycaemic events. Until long-term efficacy and safety data are available, we suggest a cautious approach to therapy with insulin glargine or detemir.

Local corticosteroid injection for carpal tunnel syndrome

Abstract: Background Carpal tunnel syndrome is a clinical syndrome manifested by signs and symptoms of irritation of the median nerve at the carpal tunnel in the wrist. Local corticosteroid injection for carpal tunnel syndrome has been studied but its effectiveness is unknown. Objectives To evaluate the effectiveness of local corticosteroid injection for carpal tunnel syndrome versus placebo injection or other non-surgical interventions. Search strategy We searched the Cochrane Neuromuscular Disease Group Trials register (searched May 2006), MEDLINE (searched January 1966 to May 2006), EMBASE (searched January 1980 to May 2006) and CINAHL (searched January 1982 to May 2006). Selection criteria Randomized or quasi-randomized studies. Data collection and analysis Three authors independently selected the trials and rated their overall quality. Relative risks and 95% confidence intervals were calculated for each trial and summary relative risks and 95% confidence intervals were also calculated. Main results We included 12 studies with altogether 671 participants. Two high quality randomized controlled trials with altogether 141 participants demonstrated clinical improvement of carpal tunnel syndrome at one month or less following local corticosteroid compared to placebo injection (relative risk 2.58 (95% confidence intervals 1.72 to 3.87)). One trial compared local corticosteroid injection to oral corticosteroid and at 12 weeks after treatment there was significantly more improvement in the injection group (mean difference -7.10 (95% confidence intervals -11.68 to -2.52)). In one trial, the rate of improvement after one month was greater after local than systemic corticosteroid injection (relative risk 3.17 (95% confidence intervals 1.02 to 9.87)). In one trial, symptoms did not improve significantly more in the injection group at eight weeks after injection compared to treatment with anti-inflammatory medication and splinting (mean difference 0.10 (95% confidence intervals -0.33 to 0.53)). Two injections versus one injection of local corticosteroid did not provide further clinical improvement, mean difference -3.80 (95% CI -9.27 to 1.67). Authors' conclusions Local corticosteroid injection for carpal tunnel syndrome provides greater clinical improvement in symptoms one month after injection compared to placebo. Significant symptom relief beyond one month has not been demonstrated. Local corticosteroid injection provides significantly greater clinical improvement than oral corticosteroid for up to three months. Local corticosteroid injection does not significantly improve clinical outcome compared to either anti-inflammatory treatment and splinting after eight weeks or Helium-Neon laser treatment after six months. Two local corticosteroid injections do not provide significant added clinical benefit compared to one injection.

Outreach and Early Warning Systems (EWS) for the prevention of intensive care admission and death of critically ill adult patients on general hospital wards

Abstract: Background Despite the fact that outreach and early warning systems (EWS) are an integral part of a hospital wide systems approach to improve the early identification and management of deteriorating patients on general hospital wards, the widespread implementation of these interventions in practice is not based on robust research evidence. Objectives The primary objective was to determine the impact of critical care outreach services on hospital mortality rates. Secondary objectives included determining the effect of outreach services on intensive care unit (ICU) admission patterns, length of hospital stay and adverse events. Search methods The review authors searched the following electronic databases: EPOC Specialised Register, The Cochrane Central Register of Controlled Trials (CENTRAL) and other Cochrane databases (all on The Cochrane Library 2006, Issue 3), MEDLINE (1996-June week 3 2006), EMBASE (1974-week 26 2006), CINAHL (1982-July week 5 2006), First Search (1992-2005) and CAB Health (1990-July 2006); also reference lists of relevant articles, conference abstracts, and made contact with experts and critical care organisations for further information. Selection criteria Randomised controlled trials (RCTs), controlled clinical trials (CCTs), controlled before and after studies (CBAs) and interrupted time series designs (ITS) which measured hospital mortality, unanticipated ICU admissions, ICU readmissions, length of hospital stay and adverse events following implementation of outreach and EWS in a general hospital ward to identify deteriorating adult patients versus general hospital ward setting without outreach and EWS were included in the review. Data collection and analysis Three review authors independently extracted data and two review authors assessed the methodological quality of the included studies. Meta-analysis was not possible due to heterogeneity. Summary statistics and descriptive summaries of primary and secondary outcomes are presented for each study. Main results Two cluster-randomised control trials were included: one randomised at hospital level (23 hospitals in Australia) and one at ward level (16 wards in the UK). The primary outcome in the Australian trial (a composite score comprising incidence of unexpected cardiac arrests, unexpected deaths and unplanned ICU admissions) showed no statistical significant difference between control and medical emergency team (MET) hospitals (adjusted P value 0.640; adjusted odds ratio (OR) 0.98; 95% confidence interval (CI) 0.83 to 1.16). The UK-based trial found that outreach reduced in-hospital mortality (adjusted OR 0.52; 95% CI 0.32 to 0.85) compared with the control group. Authors' conclusions The evidence from this review highlights the diversity and poor methodological quality of most studies investigating outreach. The results of the two included studies showed either no evidence of the effectiveness of outreach or a reduction in overall mortality in patients receiving outreach. The lack of evidence on outreach requires further multi-site RCT's to determine potential effectiveness.

Preoperative chemotherapy for women with operable breast cancer

Abstract: Background Currently, preoperative chemotherapy is the standard of care in locally advanced breast cancer to achieve local tumour downsizing in order to make surgery possible. Since the early 1980s, the role of preoperative chemotherapy in early stage (or operable) breast cancer has been the subject of study. Potential advantages are early introduction of systemic therapy, determination of chemosensitivity, reduction of tumour volume and downstaging of surgical requirement. Concerns exist about local control after downsized surgery and the delay of local treatment in patients with tumours resistant to chemotherapy. Objectives To assess the effectiveness of preoperative chemotherapy in women with operable breast cancer when compared to postoperative chemotherapy. Search methods The Specialised Register maintained by the Editorial Base of the Cochrane Breast Cancer Group was searched on 4th of August 2005. Selection criteria Randomised trials comparing preoperative chemotherapy with postoperative in women with operable breast cancer. Data collection and analysis Studies were assessed for eligibility and quality, and data were extracted by two independent review authors. Hazard ratios were derived for time-to-event outcomes directly or indirectly using the methods described by Parmar. Relative risks were derived for dichotomous outcomes. Meta-analyses were performed using fixed effect model. Main results We identified 14 eligible studies which randomised a total of 5,500 women. Median follow-up ranged from 18 to 124 months. Eight studies described a satisfactory method of randomisation. Data, based on 1139 estimated deaths in 4620 women available for analysis, show equivalent overall survival rates with a HR of 0.98 (95% CI, 0.87 to 1.09; p, 0.67; no heterogeneity). Preoperative chemotherapy increases breast conservation rates, yet at the associated cost of increased loco regional recurrence rates. However, this rate was not increased as long as surgery remains part of the treatment even after complete tumour regression (HR, 1.12; 95% CI, 0.92 to 1.37; p, 0.25; no heterogeneity. Preoperative chemotherapy was associated with fewer adverse effects. Pathological complete response is associated with better survival than residual disease (HR, 0.48; 95% CI, 0.33 to 0.69; p, < 10-4). Authors' conclusions This review suggests safe application of preoperative chemotherapy in the treatment of women with early stage breast cancer in order to down-stage surgical requirement, to evaluate chemosensitivity and to facilitate translational research.

Inhaled corticosteroids for stable chronic obstructive pulmonary disease (Review)

Abstract: Background The role of inhaled corticosteroids (ICS) in chronic obstructive pulmonary disease ( COPD) has been the subject of much controversy. Major international guidelines recommend selective use of ICS. Recently published meta-analyses have reported conflicting findings on the effects of inhaled steroid therapy in COPD. Objectives The objective of the review is to determine the efficacy of regular use of inhaled corticosteroids in patients with stable COPD. Search strategy A pre-defined search strategy was used to search the Cochrane Airways Group specialised register for relevant literature. Searches are current as of October 2006. Selection criteria We selected randomised trials comparing any dose of any type of inhaled steroid with a placebo control in patients with COPD. Acute bronchodilator reversibility to short term beta2-agonists and bronchial hyperresponsiveness were not exclusion criteria. The a priori primary outcome was change in lung function. Data on mortality, exacerbations, quality of life and symptoms, rescue bronchodilator use, exercise capacity, biomarkers and safety were also analysed. Data collection and analysis Two review authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials. Main results Forty-seven primary studies with 13,139 participants met the inclusion criteria. Medium term use of ICS ( two months and up to six months) resulted in a small improvement in FEV1 in some studies. Long term use of ICS ( six months) did not significantly reduce the rate of decline in FEV1 in COPD patients ( weighted mean difference (WMD) 5.80 ml/year with ICS over placebo, 95% CI -0.28 to 11.88, 2333 participants). There was no statistically significant effect on mortality in COPD patients (OR 0.98, 95% CI 0.83 to 1.16, 8390 participants). Long term use of ICS reduced the mean rate of exacerbations in those studies where pooling of data was possible (WMD -0.26 exacerbations per patient per year, 95% CI -0.37 to -0.14, 2586 participants). ICS slowed the rate of decline in quality of life, as measured by the St George's Respiratory Questionnaire (WMD -1.22 units/year, 95% CI -1.83 to -0.60, 2507 participants). Response to ICS was not predicted by oral steroid response, bronchodilator reversibility or bronchial hyper-responsiveness in COPD patients. There was an increased risk of oropharyngeal candidiasis (OR 2.49, 95% CI 1.78 to 3.49, 4380 participants) and hoarseness. The few long term studies that measured bone effects generally showed no major effect on fractures and bone mineral density over 3 years. Authors' conclusions Patients and clinicians should balance the potential benefits of inhaled steroids in COPD ( reduced rate of exacerbations, reduced rate of decline in quality of life), against the known increase in local side effects ( oropharyngeal candidiasis and hoarseness). The risk of long term adverse effects is unknown.