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PubMed2001

Bisphosphonates in multiple myeloma.

BACKGROUND: Multiple myeloma is a disease characterized by the neoplastic proliferation of a clone of plasma cells that can lead to bone destruction. Bisphosphonates are specific inhibitors of osteoclastic activity. Therefore, there is a pharmacological basis for their use in multiple myeloma. However, the exact clinical role of bisphosphonates in multiple myeloma remains unclear. OBJECTIVES: Primary: to determine whether adding bisphosphonates to standard therapy in multiple myeloma decreases skeletal-related morbidity (pathological fractures), skeletal-related mortality and overall mortality. Secondary: to determine the effects of bisphosphonates on pain, quality of life and incidence of hypercalcemia. SEARCH STRATEGY: We searched MEDLINE (1966 - June 2001), LILACS (1982 - June 2001), EMBASE (1974 - December 2000) and the Cochrane Controlled Trials Register (all years, latest Issue 03/2001) to identify all randomized trials in multiple myeloma. All of these references were accessed in order to identify trials related to the use of bisphosphonates in myeloma. All relevant references in each article were also scanned. We also performed a handsearch of relevant meeting proceedings from 1993 to 2000. Additionally, manufacturers of bisphosphonates and researchers in the field were contacted. SELECTION CRITERIA: Randomised trials with a parallel design on the use of bisphosphonate in myeloma compared with placebo or no treatment as a control group. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial eligibility, methodological quality and abstracted data. A third reviewer checked all data after the extraction was completed. Statistical heterogeneity was tested using random and fixed effect models. All pooled data are reported using Peto odds ratios and, when appropriate, as absolute risk reduction and the number needed to treat to prevent or to cause a pathological event. MAIN RESULTS: Eleven trials were included with 1113 patients analysed in bisphosphonates groups, and 1070 analysed in control groups. There was no significant statistical heterogeneity among trials for the endpoints selected for comparison in this review. The pooled analysis of the published evidence demonstrated the beneficial effect of bisphosphonates on prevention of pathological vertebral fractures [OR=0.59 (95% confidence interval (CI) 0.45-0.78); P=0.0001] and on amelioration of pain [OR = 0.59 (95%CI 0.46-0.76); P=0.00005]. However, the analysis of the effect of bisphosphonates on pain was based on clinically heterogeneous data and must be interpreted with caution. Although there was no statistical heterogeneity between groups, the benefit was most apparent with clodronate and pamidronate. In absolute terms, the result may be interpreted to mean that 10 (95%CI 7-20) patients with multiple myeloma should be treated to prevent one vertebral fracture, and 11 (95%CI 7-28) to prevent one patient experiencing pain. We found no significant effect of bisphosphonates on mortality, on the reduction of non-vertebral fractures or on the incidence of hypercalcemia. There were no significant adverse effects associated with the administration of bisphosphonates. Our results are based on the extraction of published data, which were sometimes poorly reported, and thus the results should be understood as the best possible summation of available evidence. REVIEWER'S CONCLUSIONS: Adding bisphosphonates to the treatment of myeloma reduces pathological vertebral fractures and pain but - from the published evidence - not mortality. On current evidence, clodronate or pamidronate may be the preferred agents.

Bone Diseases↗
PubMed2001

Media-based behavioural treatments for behavioural disorders in children.

BACKGROUND: Prevalence studies show that behaviour problems in children are quite common (10-15% in preschoolers). These problems may manifest as, for example anxiety, sadness, over-activity and tantrums. Some studies have shown that these problems can be persistent, and that they lead to a range of problems in adolescence and adulthood. Many approaches are used to address behavioural problems such as medication, or more usually, psychological treatments either directly with the child and/or his/her family. Behavioural interventions have been shown to be highly effective but access to these treatments is limited due to factors such as time and expense. Presenting the information parents need in order to manage these behaviour problems in booklet or other media-based format would reduce the cost and thus increase access to these interventions. In the adult population it seems that media-based interventions such as these can be moderately effective. Given that the cost of media-based treatment is so low it is useful to know how effective they are when given to parents. It was hypothesised that media-based treatments would be less effective than conventional psychological treatments and that efficacy would improve with increasing amounts of therapist intervention. OBJECTIVES: To review the effects of media-based behavioural therapies (definitions below), for any young person with a behavioural disorder (however diagnosed) compared to standard care and no treatment controls. SEARCH STRATEGY: A range of electronic databases were systematically searched using a specified search strategy. Individual journals of interest were hand-searched where necessary, references in all selected trials were checked for other trials and, where it was thought to be of possible use, individual authors were contacted for additional information. SELECTION CRITERIA: Randomised controlled trials of behavioural media-based treatments for behaviour problems in children. DATA COLLECTION AND ANALYSIS: Abstracts and titles of studies identified from searches of electronic databases were read to determine whether they met the inclusion criteria. Full copies of those possibly meeting these criteria from electronic or other searches were assessed by the reviewer and queries were resolved by discussion with an independent rater. Data were analysed using Revman. MAIN RESULTS: In general, media-based therapies for behavioural disorders in children had a moderate effect when compared with both no-treatment controls and with standard care. Significant improvements were often made with the addition of up to 2 hours of therapist time. REVIEWER'S CONCLUSIONS: These formats of delivering behavioural interventions for carers of children are possibly worth considering in clinical practice. For straightforward cases media-based interventions may be enough to make clinically significant changes in a child's behaviour, and reduce the amount of time primary care workers have to devote to each case. Consequently this would increase the number of families who could possibly benefit from this type of intervention. Media-based therapies would therefore appear to have both clinical and economic implications as regards the treatment of children with behavioural problems.

Caregivers↗
PubMed2001

Aminopyridines for symptomatic treatment in multiple sclerosis.

BACKGROUND: Because of their ability to increase nerve conduction in demyelinated nerve fibers, potassium channel blockers 4-aminopyridine (AP) and 3,4-diaminopyridine (DAP) have been proposed as a symptomatic therapy for people with multiple sclerosis (MS). OBJECTIVES: To determine the efficacy and safety of aminopyridines in improving neurological deficits in people with MS. SEARCH STRATEGY: Computerised general (MEDLINE, EMBASE) and specialised databases (Cochrane MS Group's trials register, CCTR). Hand search of bibliographic references from retrieved studies and recent MS symposia reports. Contact with principal investigators of known studies. SELECTION CRITERIA: Trials were included if they fulfilled all following criteria: randomised controlled trials (RCTs); adults with MS, out of exacerbation; AP or DAP treatment versus placebo; clinical endpoints. DATA COLLECTION AND ANALYSIS: We identified 26 potentially pertinent studies. Three reviewers independently extracted data and assessed trial quality from the 16 studies available as full papers. MAIN RESULTS: Five studies (six publications) and 144 participants were considered in this review. Two more abstracts are awaiting assessment. All five studies were single-centre, double-blind, crossover trials. Four studies assessed the efficacy of AP versus placebo, one compared DAP with active placebo. The duration of treatment ranged from hours to three months. The median quality score of the studies was 3 (range 2-5). The heterogeneity of outcome assessment and the absence of information on individual study periods, allowed quantitative pooling of results for few categorical variables. Of the 144 treated patients, there were six major side effects: one acute encephalopathy, three episodes of confusion, and two seizures. Manual muscle testing was assessed in three studies (54 patients), with 29 patients (54%) improving in at least one muscular district during study treatment versus four patients (7%) during placebo (odds ratio [OR] 14.5, 95% confidence interval [CI] 4.7-43.7). Ambulation was assessed in three studies (54 patients): 9 patients (17%) improved during study treatment versus none during placebo (p<0.001). An improvement in EDSS score was found in 13 of the 144 participants during study treatment (9%) versus none during placebo (p<0.001). No improvement in neuropsychological tests was found in the two trials that evaluated cognitive function. Finally, 47 of 136 people with MS (35%) felt improved when receiving the study drug, against 7(5%) on placebo (OR 9.7, 95% CI 4.3-22.0). REVIEWER'S CONCLUSIONS: Based on currently available information, no unbiased statement can be made about the safety or efficacy of aminopyridines for treating MS symptoms. Furthermore, we could not obtain any data on three unpublished RCTs involving more than 300 participants. We conclude that publication bias remains a pervasive problem in this area, and that until the results of these unpublished studies are available to the scientific community, no confident estimate of effectiveness of aminopyridines in the management of MS symptoms is possible.

4-Aminopyridine↗
PubMed2000

Tricyclic drugs for depression in children and adolescents.

BACKGROUND: There is a need to identify effective and safe treatments for depression in children and adolescents. While tricyclic drugs have proven effectiveness in the treatment of depression in adults, individual studies involving children and adolescent have been equivocal. OBJECTIVES: To examine whether orally administered tricyclic antidepressants are superior to placebo in the treatment of child and adolescent depression SEARCH STRATEGY: We searched the literature using CD ROM Silver Platter and On-Line MEDLINE (1966-1997) and Excerpta Medica (June 1974-1997) data bases. Terms used for the search were: the exploded terms child and depression; the Medical Subject Headings of antidepressant drugs, tricyclic and affective disorders; individual tricyclic drugs by name; names of well-known researchers in the field; and school phobia. We searched the trials database of the Cochrane Collaboration Depression, Anxiety and Neurosis Group. Abstracts in English (of English and non-English papers) were reviewed. Bibliographies of previously published reviews and papers describing original research were cross-checked. Current Contents was screened for recent publications. We contacted authors of abstracts describing "work in progress" identified in conference proceedings of the American Academy of Child and Adolescent Psychiatry to determine whether they held data which could be included in the meta-analysis. We have hand searched the Journal of the American Academy of Child and Adolescent Psychiatry to identify randomized controlled trials. SELECTION CRITERIA: Randomized controlled trials comparing the efficacy of orally administered tricyclic medication with placebo in depressed subjects aged 6-18 years. DATA COLLECTION AND ANALYSIS: Most studies reported multiple outcome measures including depression scales and clinical global impression scales. For each study the best available depression measure was taken as the index measure of depression outcome. Predetermined criteria were established to assist in the ranking of measures. Where authors reported categorical outcomes we calculated individual and pooled odds ratios for the odds of improvement in treated compared with control subjects. For continuous outcomes pooled effect sizes were calculated as the number of standard deviations by which the change in depression scores for the treatment group exceeded those for the control groups. MAIN RESULTS: Twelve studies fulfilled the criteria for inclusion in the review, eight from which dichotomous outcome data could be extracted, and eleven from which continuous outcome data could be extracted. Pooled odds ratios calculated from the dichotomous data indicated no advantage of treatment over placebo for children or adolescents (odds ratio = 0.83, 95% confidence interval 0.48 to 1.42). Effect size calculations from the continuous data suggested a statistically significant but small benefit of treatment over placebo in reducing symptoms for the aggregate sample (effect size = -0.38, 95% confidence interval -0.74 to -0.02) with subgroup analyses suggesting a larger benefit among adolescents (effect size = -0.59, 95% confidence interval -1.12 to -0.06), and no benefit among children (effect size = 0.15, 95% confidence interval -0.34 to 0.64). Treatment with a tricyclic antidepressant caused more vertigo (odds ratio = 8.47, 95% confidence interval 1.40 to 51.0), orthostatic hypotension (odds ratio = 4.77, 95% confidence interval 1.11 to 20.49) and dry mouth (odds ratio = 5.19, 95% confidence interval 1.15 to 23.51) than did placebo, but there was no statistically significant difference in other possible adverse effects. REVIEWER'S CONCLUSIONS: Data suggest tricyclic antidepressants are of unlikely benefit in the treatment of depression in pre pubertal children. There is marginal evidence to support the use of tricyclic antidepressants in the treatment of depression in adolescents, although the magnitude of effect is likely to be moderate at best.

Administration, Oral↗
PubMed2001

Biphasic versus triphasic oral contraceptives for contraception.

BACKGROUND: Side effects caused by oral contraceptives discourage compliance with and continuation of oral contraceptives. A suggested disadvantage of biphasic oral contraceptive pills as compared to triphasic oral contraceptive pills is an increase in breakthrough bleeding. We conducted this systematic review to examine this potential disadvantage. OBJECTIVES: To compare biphasic oral contraceptives with triphasic oral contraceptives in terms of efficacy, cycle control, and discontinuation due to side effects. SEARCH STRATEGY: We searched computerized databases MEDLINE, EMBASE, POPLINE and the Cochrane Controlled Trial Register. Additionally we searched the reference lists of potentially relevant articles and book chapters. We also contacted the authors of relevant studies and pharmaceutical companies in Europe and the U.S. SELECTION CRITERIA: We included randomized controlled trial comparing any biphasic oral contraceptive with any triphasic oral contraceptive when used to prevent pregnancy. DATA COLLECTION AND ANALYSIS: We examined the studies found during the various literature searches for possible inclusion and assessed their methodological quality using the Cochrane guidelines. We contacted the authors of all included studies and of possibly randomized studies for supplemental information about the study methods and outcomes. We entered the data in RevMan 3.1 and later imported them into RevMan 4.1. We calculated Peto odds ratios for incidence of incidence of discontinuation due to medical reasons, intermenstrual bleeding, absence of withdrawal bleeding, and discontinuation due to intermenstrual bleeding. MAIN RESULTS: Only two trials of limited quality met our inclusion criteria. Larranaga (1978) compared two biphasic and one triphasic pills, each containing levonorgestrel and ethinyl estradiol. No important differences emerged, and the frequency of discontinuation due to medical problems was similar with all three pills. Percival Smith (1990) compared a biphasic pill containing norethindrone (Ortho 10/11) with a triphasic pill containing levonorgestrel (Triphasil) and another triphasic pill containing norethindrone (Ortho 7/7/7). The biphasic pill had inferior cycle control compared with the levonorgestrel triphasic pill. The odds ratio of cycles with intermenstrual bleeding was 1.7 (95%CI 1.3-2.2) for the biphasic pill compared with the triphasic levonorgestrel pill. The odds ratio of cycles without withdrawal bleeding was 6.5 (95%CI 3.1-13). In contrast, cycle control with the biphasic pill was comparable to that with the triphasic pill containing the same progestin (norethindrone). REVIEWER'S CONCLUSIONS: The available evidence is limited and of poor quality; the internal validity of these trials is questionable. Given the high losses to follow-up after randomization, these reports may be better considered observational in nature. Given that caveat, the biphasic pill containing norethindrone was associated with inferior cycle control compared with the triphasic pill containing levonorgestrel. This suggests that the choice of progestin may be more important that the phasic regimen in determining bleeding patterns.

Contraception↗
PubMed2001

Palliative radiotherapy regimens for non-small cell lung cancer.

BACKGROUND: Palliative radiotherapy (RT) to the chest is often used in patients with lung cancer, but RT regimens are more often based on tradition than research results. OBJECTIVES: To discover the most effective and least toxic regimens of palliative RT, and whether higher doses increase survival. SEARCH STRATEGY: Electronic databases, reference lists, handsearching of journals and conference proceedings, and discussion with experts were used to identify potentially eligible trials, published and unpublished. SELECTION CRITERIA: Randomised controlled clinical trials comparing different regimens of palliative RT in patients with non-small lung cancer. DATA COLLECTION AND ANALYSIS: Ten randomised trials were reviewed. There were important differences in the doses of RT investigated, the patient characteristics and the outcome measures. Because of this heterogeneity no meta-analysis was attempted. MAIN RESULTS: There is no strong evidence that any regimen gives greater palliation. Higher dose regimens give more acute toxicity. There is evidence for a modest increase in survival (6% at 1 year and 3% at 2 years) in patients with better performance status (PS) given higher dose RT. REVIEWER'S CONCLUSIONS: The majority of patients should be treated with short courses of palliative RT, of 1 or 2 fractions. Care should be taken with the dose to the spinal cord. The use of high dose palliative regimens should be considered for and discussed with selected patients with good PS. More research is needed into reducing the acute toxicity of large fraction regimens and into the role of radical compared to high dose palliative RT and more homogeneous studies are needed.

Carcinoma, Non-Small-Cell Lung↗
PubMed2000

Intravenous indomethacin for preventing mortality and morbidity in very low birth weight infants.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: Indomethacin is used to treat symptomatic patent ductus arteriosus and may prevent or limit intraventricular haemorrhage in the neonatal period. This review examines the effectiveness of prophylactic intravenous indomethacin in reducing the mortality and morbidity associated with these conditions in infants weighing less than 1750 grams at birth. SEARCH STRATEGY: A literature search from January 1980 to October 1994 was made in three computerised data bases: Medline; Embase; and the Oxford Database of Perinatal Trials. The search was updated in February 1997. SELECTION CRITERIA: Strict selection criteria were applied to clinical trials: the population had to be newborn infants of birth weight < 1751 grams; the intervention had to be prophylactic intravenous indomethacin; the trial had to be randomised and controlled; and at least one of several prespecified outcomes had to be reported in the results. DATA COLLECTION AND ANALYSIS: The methodological quality of each study was assessed using explicit criteria. Data on relevant outcome measures were extracted on two separate occasions and, where appropriate, the results of individual trials were combined using meta-analysis techniques to provide a pooled estimate of effect. MAIN RESULTS: There is a trend towards reduced neonatal mortality in infants receiving prophylactic indomethacin, pooled relative risk (RR) = 0. 85 [95% CI 0.66 to 1.09]. The incidence of symptomatic patent ductus arteriosus is significantly reduced in treated infants, pooled RR = 0.35 [0.26 to 0.47] but there is no evidence that treatment affects respiratory outcomes. Prophylactic indomethacin significantly reduces the incidence of Grade 3 and 4 intraventricular haemorrhage in treated infants, pooled RR = 0.60 [0.43 to 0.83]. There is no evidence to suggest prophylactic indomethacin is associated with any long term adverse effect although there is a trend in treated infants towards an increased incidence of necrotizing enterocolitis, and some evidence that treatment may transiently impair renal function. There is no evidence that haemostasis is disturbed. REVIEWER'S CONCLUSIONS: Prophylactic treatment with indomethacin has a number of immediate benefits, in particular a reduction in symptomatic patent ductus arteriosus and severe intraventricular haemorrhage. There is no evidence at present of long-term harm. Further trials are needed to assess more precisely the effects, both beneficial and harmful, on short and long-term outcomes.

Cardiovascular Agents↗
PubMed2005

What works for adolescents with AN? A systematic review of psychosocial interventions.

OBJECTIVE: To determine the effectiveness of psychosocial interventions for adolescents with AN. METHODS: An extensive and systematic literature search was conducted for randomised controlled trials (RCTs) addressing the effectiveness of psychosocial interventions for teenagers (11-18 years) with AN. RESULTS: Eight RCTs were located meeting the review's inclusion criteria, the majority of which focused on some form of family-related intervention. DISCUSSION: Unfortunately, a lack of robust primary research on which to base the review meant that clear recommendations could not be made. More good quality research, examining a range of interventions, and involving larger samples, is required before a similar systematic review is executed.

Adolescent↗
PubMed2000

Immunotherapy for recurrent miscarriage.

BACKGROUND: Immunologic aberrations might be the cause of recurrent early pregnancy loss in some women. OBJECTIVES: The objective of this review was to assess the effects of leukocyte immunisation or other immunologic treatments such as intravenous immune globulin (IVIG) on the live birth rate in women with previous unexplained recurrent miscarriages. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register was searched. Individual patient data were obtained from the American Society for Reproductive Immunology and by MEDLINE search. Date of last search: December 1999. SELECTION CRITERIA: Randomised trials of immunotherapy in women with three or more prior miscarriages, no more than one live birth, all non-immunologic causes ruled out and no simultaneous treatment intervention. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality were assessed by one reviewer. MAIN RESULTS: Eighteen trials of high quality were included. The various forms of immunotherapy did not show significant differences between treatment and control groups. For paternal cell immunisation, the odds ratios was 1.05, 95% confidence interval 0.75 to 1.47. For third party donor cell immunization, the odds ratio was 1.39, 95% confidence interval 0.68 to 2.82. For trophoblast membrane infusion the odds ratio was 0.40, 95% confidence interval 0.11 to 1.45. For intravenous immune globulin (IVIG), the odds ratio was 1.14, 95% confidence interval 0. 66 to 1.95. REVIEWER'S CONCLUSIONS: Paternal cell immunization, third party donor leukocytes, trophoblast membranes, and IVIG provide no significant beneficial effect over placebo in preventing further miscarriages.

Abortion, Habitual↗
PubMed2001

Dietary advice given by a dietitian versus other health professional or self-help resources to reduce blood cholesterol.

BACKGROUND: The average level of blood cholesterol is an important determinant of the risk of coronary heart disease. Blood cholesterol can be reduced by dietary means. Although dietitians are trained to provide dietary advice, for practical reasons it is also given by other health professionals and occasionally through the use of self-help resources. OBJECTIVES: To assess the effects of dietary advice given by a dietitian compared with another health professional, or the use of self-help resources, in reducing blood cholesterol in adults. SEARCH STRATEGY: We searched The Cochrane Library (to Issue 2 1999), MEDLINE (1966 to January 1999), EMBASE (1980 to December 1998), Cinahl (1982 to December 1998), Human Nutrition (1991 to 1998), Science Citation Index, Social Sciences Citation Index, hand searched conference proceedings on nutrition and heart disease, and contacted experts in the field. SELECTION CRITERIA: Randomised trials of dietary advice given by a dietitian compared with another health professional or self-help resources. The main outcome was difference in blood cholesterol between dietitian groups compared with other intervention groups. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Eleven studies with 12 comparisons were included, involving 704 people receiving advice from dietitians, 486 from other health professionals and 551 people using self-help leaflets. Four studies compared dietitian with doctor, seven with self-help resources, and one compared dietitian with nurse. Participants receiving advice from dietitians experienced a greater reduction in blood cholesterol than those receiving advice only from doctors (-0.25 mmol/L (95% CI -0.37, -0.12 mmol/L)). There was no statistically significant difference in change in blood cholesterol between dietitians and self-help resources (-0.10 mmol/L (95% CI -0.22, 0.03 mmol/L)). No statistically significant differences were detected for secondary outcome measures between any of the comparisons with the exception of dietitian versus nurse for HDLc, where the dietitian groups showed a greater reduction (-0.06 mmol/L (95% CI -0.11, -0.01)). No significant heterogeneity between the studies was detected. REVIEWER'S CONCLUSIONS: Dietitians were better than doctors at lowering blood cholesterol in the short to medium term, but there was no evidence that they were better than self-help resources. The results should be interpreted with caution as the studies were not of good quality and the analysis was based on a limited number of trials. More evidence is required to assess whether change can be maintained in the longer term. There was no evidence that dietitians provided better outcomes than nurses.

Cholesterol↗
PubMed2000

Continuous electronic heart rate monitoring for fetal assessment during labor.

BACKGROUND: Electronic fetal monitoring (EFM) has been widely adopted. There is debate about its overall effectiveness as well as the relative merits of routine application versus use for high-risk pregnancies only. OBJECTIVES: The objective of this review was to assess the effects of routine continuous electronic fetal monitoring during labour compared with intermittent auscultation. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register, Medline (1966 to 1994), and reference list of relevant articles. We also contacted experts in the field. SELECTION CRITERIA: Randomised trials comparing routine continuous electronic fetal monitoring with intermittent auscultation. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer, and their accuracy was confirmed independently by a second person. A single reviewer assessed study quality based on criteria developed by others for randomised controlled trials. Data reported from similar studies were used to calculate a combined risk estimate for each of eight outcomes. MAIN RESULTS: Nine studies involving 18,561 women and their 18,695 infants were included. The trials were of variable quality. A statistically significant decrease was associated with routine continuous EFM for neonatal seizures (relative risk (RR) = 0. 51, confidence interval (CI) = 0.32,0.82). The protective effect for neonatal seizures was only evident in studies with high-quality scores. No significant differences were observed in 1-minute Apgar scores below 4, 1-minute Apgar scores below 7, rate of admissions to neonatal intensive care units, and perinatal death. An increase associated with the use of EFM was observed in the rate of cesarean delivery (RR = 1.41, CI = 1.23,1.61) and operative vaginal delivery (RR = 1.20, CI = 1.11,1.30). REVIEWER'S CONCLUSIONS: The only clinically significant benefit from the use of routine continuous EFM was in the reduction of neonatal seizures. In view of the increase in cesarean and operative vaginal deliveries, the long-term benefit of this reduction must be evaluated in the decision reached jointly by the pregnant woman and her clinician to use continuous EFM or intermittent auscultation during labor.

Cardiotocography↗
PubMed2003

[How evidence-based is medicine? A systematic literature review].

INTRODUCTION: In the early 1990es, it was supposed that only 10-15 per cent of medical interventions were based on results from randomised controlled studies. A systematic review of available empirical studies on the topic was performed in order to elucidate to what extent interventions in different medical specialities are evidence-based. METHODS: Literature search in MEDLINE for the period 1995-2002 retrieved 15 published studies, which investigated to what extent interventions in individual patients were based on randomised controlled studies. The retrieved papers were read critically in order to extract data concerning the patients, their clinical problems, and the interventions performed. Finally, the classification of the clinical scientific methods, which was the evidence-base of the interventions, were extracted. RESULTS: In general internal medicine over 50 per cent of the interventions seems warranted by randomised controlled studies, whereas the figures are somewhat lower for general practice, surgery, and dermatology. A small study shows that psychiatry may candidate for the top score with 65 per cent of the interventions based on randomised controlled studies. However, more studies are requested to confirm this finding. DISCUSSION: It is suggested to perform regular studies of the evidence-base for clinical interventions in different specialities, preferably with assistance from colleagues from other specialities. There should be sufficient access to literature databases and databases of "digested" evidence, which was not always the case in the reviewed studies. It is important that the indication for an intervention has been evaluated in randomised controlled studies, which compared a possible intervention to observation without treatment or treatment with placebo--a mere comparison in randomised controlled studies of two active interventions may not be sufficient evidence. Authors are encouraged to agree on a comparable classification scale for grading the evidence in publications. It is concluded that there is a need for this kind of regular audit in order to safeguard that patients are offered interventions based on the best evidence.

Clinical Medicine↗
PubMed2003

Beyond Medline: reducing bias through extended systematic review search.

OBJECTIVE: To evaluate the sensitivity and precision of various extended search methods in identifying randomized controlled trials (RCTs) for systematic reviews. METHOD: Prospective analysis of extended search methods (specialized databases or trial registries, reference lists, hand-searching, personal communication, and Internet) used in two systematic reviews of RCTs. The gold standard was the total number of RCTs identified by major databases (MEDLINE, EMBASE, etc.) and extended search strategies combined. Sensitivity was the proportion of all known RCTs identified by any extended search method. Precision reflected the proportion of all items uncovered by any extended search method that actually were RCTs. RESULTS: The extended search identified 94 additional RCTs for the systematic reviews beyond those identified with the major databases. Specialized databases and trial registries had the highest sensitivity and precision for the lipid-lowering project (13.6% and 52.7%, respectively; p < .05) followed by scanning of reference lists (7.2% sensitivity and 41.9% precision; p <.05). Hand-searching was more effective than personal communication and Internet searching (1.7% sensitivity and 12.2% precision; p < .05). The acupuncture project had slightly different results, with the specialized databases and trial registries tied with the review of reference lists for highest sensitivity (14.2%). The precision followed the same trend as the lipid-lowering project (17.6% specialized databases; 8.3% reference lists; p < .05). A post-hoc analysis showed that 75 of the 94 RCTs were indexed in the major databases but missed by the major database search. CONCLUSIONS: Extended searching identified additional RCTs for the systematic reviews beyond those found in major databases. Specialized databases and trial registries were most effective. An important number of RCTs were missed by the major database search. Timing and accuracy of indexing may explain this finding. The definitive measure, whether there is an association between the method used to uncover RCTs, the quality of the items uncovered and their impact on systematic review results, is yet to be determined.

Humans↗
PubMed2001

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids are interventions designed to help people make specific and deliberative choices among options (including status quo) by providing (at a minimum) information on the options and outcomes relevant to a person's health status. A systematic review is needed to summarize what is known about their efficacy. OBJECTIVES: 1. To create an inventory of existing decision aids. 2. To conduct a systematic review of randomized controlled trials of decision aids aimed at improving people's decision making and outcomes. SEARCH STRATEGY: The following electronic databases were searched: MEDLINE, EMBASE, PsycINFO, CINAHL, Aidsline, Cancerlit, the Cochrane Controlled Trials Register. In addition, individuals known to be active in the field of decision support were contacted. SELECTION CRITERIA: We screened titles and abstracts for all interventions providing structured, detailed, and specific information on treatment or screening options and outcomes to aid decision making. Information about the decision aids was compiled in an inventory and those evaluated in a randomized controlled trial were reviewed in detail. DATA COLLECTION AND ANALYSIS: Using Cochrane review methods, two reviewers independently screened and extracted data on several evaluation criteria. Results of randomized trials were pooled using weighted mean differences and relative risks with all data analysed using a random effects model. MAIN RESULTS: Eighty-seven decision aids were identified. Twenty-three of them had been evaluated in 24 randomized controlled trials. Among the trials comparing decision aids to usual care interventions, decision aids performed better in terms of: a) greater knowledge of options in seven of seven studies (weighted mean difference (WMD = 19 out of 100, 95% confidence interval (CI): 13,25); b) more realistic expectations in two of three studies (RR=1.48 95%CI 1.02, 2.14); c) lower decisional conflict related to feeling informed in three of three studies (WMD = -9.0 of 100 95%CI: -15, -3); d) reducing the proportion of people who were passive in decision making in three of four studies (RR = 0.63, 95% CI: 0.5, 0.8). When simpler decision aids were compared to more detailed ones, the relative improvement was significant in: a) improved knowledge in two of seven studies (WMD = 4 out of 100, 95% CI: 2, 5); b) realistic expectations in two of two studies (relative risk (RR ranged from 1.5 95%CI: 1.3,1.8); and c) decisional conflict in one of two studies (WMD= -4 95% CI -8,-0.2). There was a consistent trend for decision aids to do no better than comparison interventions in affecting: satisfaction with the decision in five of six studies, satisfaction with the decision making process in four of five studies, and anxiety in four of five studies. Decision aids had a variable effect on which screening or treatment options were selected. Exposure to decision aids relative to controls resulted in a consistent non-significant trend toward reduced preference for major surgery over conservative options by 21 to 42 per cent in five of five studies; however, they had no impact on circumcision in two of two studies. For colon and prostate cancer screening choices, the results were inconsistent. Two studies have shown no impact on persistence with chosen option and few studies have shown significant benefits on general health outcomes (two of three studies), or disease-specific health outcomes (one of four studies). REVIEWER'S CONCLUSIONS: The number of decision aids is expanding, but there is considerable overlap in some areas leaving gaps in others. Trials of decision aids indicate that they are superior to usual care interventions in improving knowledge and realistic expectations of the benefits and harms of options; reducing passivity in decision making; and lowering decisional conflict stemming from feeling uninformed. When simpler versions of decision aids are compared to more detailed aids, the differences in knowledge are marginal but there are other benefits in terms of creating realistic expectations and in reducing decisional conflict. To date, decision aids have had little effect on anxiety or satisfaction with the decision making process or satisfaction with the decision. Their effects on choices vary with the decision. The effects on persistence with chosen therapies and health outcomes require further evaluation. The essential elements in decision aids for different groups and different types of decisions need to be established. Consensus needs to be reached regarding standards for developing and evaluating decision aids.

Decision Support Techniques↗
PubMed2000

Home-like versus conventional institutional settings for birth.

BACKGROUND: Many home-like birth centres have been established near conventional labour wards for the care of pregnant women who prefer and require little or no medical intervention during labour and birth. OBJECTIVES: The objective of this review was to assess the effects of care in a home-like birth environment compared to care in a conventional labour ward, on labour and birth outcomes. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register was searched. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing a home-like institutional birth environment to conventional hospital care for pregnant women at low risk of obstetric complications. DATA COLLECTION AND ANALYSIS: Trial quality was assessed. MAIN RESULTS: Five trials involving almost 8000 women were included. Substantial numbers of women allocated to home-like settings were transferred to standard care before or during labour, making interpretation of results difficult. Allocation to a home-like setting was associated with lower rates of intrapartum analgesia/anaesthesia (odds ratio 0.82, 95% confidence interval 0.72 to 0.93), fetal heart rate abnormalities (0.72, 95% confidence interval 0.63 to 0.81), augmented labour, and immobility during labour, as well as greater satisfaction with care, and increased likelihood of sore nipples and mastitis. There was a non-statistically significant trend towards higher perinatal mortality in the home-like setting (odds ratio 1.49, 95% confidence interval 0.79 to 2.78). REVIEWER'S CONCLUSIONS: There appear to be some benefits from home-like settings for childbirth, although increased support from caregivers may be more important. Caregivers and clients in home-like settings need to watch for signs of complications.

Birthing Centers↗
PubMed2001

Lithium for maintenance treatment of mood disorders.

BACKGROUND: Mood disorders are common, disabling and tend to be recurrent. They carry a high risk of suicide. Maintenance treatment, aimed at the prevention of relapse, is therefore of vital importance. Lithium has been used for some years as the mainstay of maintenance treatment in bipolar affective disorder, and to a lesser extent in unipolar disorder. However, the efficacy and effectiveness of prophylactic lithium therapy has been disputed. Low suicide rates in lithium-treated patients have led to claims that lithium has a specific anti-suicidal effect. If so, this is of considerable importance as treatments for mental disorders in general have not been shown convincingly to be effective in suicide prevention. OBJECTIVES: 1. To investigate the efficacy of lithium treatment in the prevention of relapse in recurrent mood disorders. 2. To examine the effect of lithium treatment on consumers' general health and social functioning, its acceptability to consumers, and the side-effects of treatment. 3. To investigate the hypothesis that lithium has a specific effect in reducing the incidence of suicide and deliberate self-harm in persons with mood disorders. SEARCH STRATEGY: The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR) and The Cochrane Controlled Clinical Trials Register (CCTR) were searched. Reference lists of relevant papers and major text books of mood disorder were examined. Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable trials, published or unpublished. Specialist journals concerning lithium were hand searched. SELECTION CRITERIA: Randomised controlled trials comparing lithium with placebo, where the stated intent of treatment was maintenance or prophylaxis. Participants were males and females of all ages with diagnoses of mood disorder. Discontinuation studies (in which all participants had been stable on lithium for some time before being randomised to either continued lithium treatment or placebo substitution) were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted from the original reports independently by two reviewers. The main outcomes studied were related to the objectives stated above. Data were analysed for all diagnoses of mood disorder and for bipolar and unipolar disorder separately. Data were analysed using Review Manager version 4.0. MAIN RESULTS: Nine studies were included in the review, reporting on 825 participants randomly allocated to lithium or placebo. Lithium was found to be more effective than placebo in preventing relapse in mood disorder overall, and in bipolar disorder. The most consistent effect was found in bipolar disorder (random effects OR 0.29; 95% CI 0.09 to 0.93 ). In unipolar disorder, the direction of effect was in favour of lithium, but the result (when heterogeneity between studies was allowed for) did not reach statistical significance. Considerable heterogeneity was found between studies in all groups of patients. The direction of effect was the same in all studies; no study found a negative effect for lithium. Heterogeneity may have been due to differences in selection of participants, and to differing exposures to lithium in the pre-study phase resulting in variable influence of a discontinuation effect. There was little reported data on overall health and social functioning of participants under the different treatment conditions, or on the participants' own views of their treatment. Descriptive analysis showed that assessments of general health and social functioning generally favoured lithium. Small absolute numbers of deaths and suicides, and the absence of data on non-fatal suicidal behaviours, made it impossible to draw meaningful conclusions about the place of lithium therapy in suicide prevention. REVIEWER'S CONCLUSIONS: This systematic review indicates that lithium is an efficacious maintenance treatment for bipolar disorder. In unipolar disorder the evidence of efficacy is less robust. This review does not cover the relative efficacy of lithium compared with other maintenance treatments, which is at present unclear. There is no definitive evidence from this review as to whether or not lithium has an anti-suicidal effect. Systematic reviews and large scale randomised studies comparing lithium with other maintenance treatments (e.g. anti-convulsants, antidepressants) are necessary. Outcomes relating to death and suicidal behaviour should be included in all future maintenance studies of mood disorder.

Antimanic Agents↗