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Pre-operative GnRH analogue therapy before hysterectomy or myomectomy for uterine fibroids.

BACKGROUND: Uterine fibroids, smooth muscle tumours of the uterus, are found in at least 25 to 35% of women over the age of 35 years. Although some of these tumours are asymptomatic, up to 50% cause symptoms severe enough to warrant therapy and surgery is the standard treatment. Fibroid growth is stimulated by oestrogen and gonadotropin releasing hormone agonists (GnRHa) which induce a state of hypoestrogenism have been investigated as a potential treatment. GnRHa treatment causes fibroids to shrink but cannot be used long term because of unacceptable symptoms and bone loss. Therefore, GnRHa may be useful pre-operatively both to reduce fibroid and uterine volume and control bleeding. OBJECTIVES: The objective of this review is to evaluate the role of pre-treatment with gonadotropin releasing hormone (GnRH) analogues prior to a major surgical procedure, either hysterectomy or myomectomy, for uterine fibroids. SEARCH STRATEGY: Electronic searches for relevant randomised controlled trials of the Cochrane Menstrual Disorders and Subfertility Group Register of Trials, MEDLINE, EMBASE, PsychLIT, Current Contents, Biological Abstracts, Social Sciences Index and CINAHL were performed. Attempts were also made to identify trials from citation lists of review articles. In most cases, the first author of each included trial was contacted for additional information. SELECTION CRITERIA: The inclusion criteria were randomised comparisons of GnRH analogue treatment versus placebo, no treatment, or other medical therapy prior to surgery, either myomectomy or hysterectomy, for uterine fibroids. DATA COLLECTION AND ANALYSIS: Nineteen RCTs were identified that fulfilled the inclusion criteria for this review. The reviewers extracted the data independently and odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes were estimated from the data of twelve trials where GnRH analogue treatment was compared with no pre-treatment and five trials where GnRH analogue treatment was compared with placebo (two trials are awaiting assessment). No RCTs of GnRH analogue treatment versus other medical therapy were identified. Results from pre-operative outcomes were combined for both types of surgery but results from intra- and post-operative outcomes were reported separately for myomectomy and hysterectomy. Subgroup analysis was performed according to type of control group, no pre-treatment or placebo, and for some outcomes there were additional subgroup analyses according to size of the uterus in gestational weeks. MAIN RESULTS: Pre- and post-operative haemoglobin (Hb) and haematocrit (HCT) were significantly improved by GnRH analogue therapy prior to surgery, and uterine volume, uterine gestational size and fibroid volume were all reduced. Pelvic symptoms were also reduced but some adverse events were more likely during GnRH analogue therapy. Hysterectomy appeared to be easier after pre-treatment with GnRH analogue therapy; there was reduced operating time and a greater proportion of hysterectomy patients were able to have a vaginal rather than an abdominal procedure. Duration of hospital stay was also reduced. Blood loss and rate of vertical incisions were reduced for both myomectomy and hysterectomy. Evidence of increased risk of fibroid recurrence after GnRH analogue pre-treatment in myomectomy patients was equivocal and no data were available to assess change in post-operative fertility. The increased costs associated with GnRH analogue therapy were not assessed. REVIEWER'S CONCLUSIONS: The use of GnRH analogues for 3 to 4 months prior to fibroid surgery reduce both uterine volume and fibroid size. They are beneficial in the correction of pre-operative iron deficiency anaemia, if present, and reduce intra-operative blood loss. If uterine size is such that a mid-line incision is planned, this can be avoided in many women with the use of GnRH analogues. For patients undergoing hysterectomy, a vaginal procedure is more like

Antineoplastic Agents, Hormonal↗

Cyclical progestogens for heavy menstrual bleeding.

BACKGROUND: Excessively heavy menstrual bleeding (HMB) or menorrhagia is an important cause of ill health in women. Eighty per cent of women treated for HMB have no anatomical pathology and so medical therapy, with the avoidance of possibly unnecessary surgery, is an attractive alternative. Of the wide variety of medications used to reduce heavy menstrual bleeding, oral progestogens are the most commonly prescribed in many western countries, although there is little objective evidence to support their use, especially in women with ovulatory menstruation. This review assesses the effectiveness of 2 different regimens of oral progestogens in reducing ovulatory HMB. OBJECTIVES: The primary objective of this review is to investigate the effectiveness of oral progestogen therapy taken either during the luteal phase or for a longer course of 21 days in achieving a reduction in menstrual blood loss in women of reproductive years with heavy menstrual bleeding (HMB). SEARCH STRATEGY: Electronic searches for relevant randomised controlled trials of the Cochrane Menstrual Disorders and Subfertility Group Register of Trials, MEDLINE, EMBASE, PsychLIT, Current Contents, Biological Abstracts, Social Sciences Index and CINAHL were performed. Attempts were also made to identify trials from citation lists of review articles. In most cases, the first author of each included trial was contacted. SELECTION CRITERIA: The inclusion criteria were randomised comparisons of oral progestogen therapy versus placebo or other medical treatments in women of reproductive years with regular heavy periods measured either objectively or subjectively and with no pathological or iatrogenic causes for their heavy menstrual blood loss. DATA COLLECTION AND ANALYSIS: Seven randomised controlled trials (RCTs) were identified that fulfilled the inclusion criteria for this review. The reviewers extracted the data independently and odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes were estimated from the data. MAIN RESULTS: No RCTs comparing progestogen treatment with placebo were identified. Comparisons between oral progestogens and other medical therapies were assessed separately according to dosage regimen, progestogens given during the luteal phase of the menstrual cycle and progestogens given for 21 days between day 5 and 26. Progestogen therapy during the luteal phase was significantly less effective at reducing menstrual blood loss when compared with tranexamic acid, danazol and the progesterone releasing intrauterine system (IUS) and there was also a strong non-significant trend in favour of nonsteroidal anti-inflammatory drugs (NSAIDs). Duration of menstruation was significantly longer with the progesterone IUS when compared with oral progestogen therapy but significantly shorter under danazol treatment. Compliance and acceptability of treatment where measured did not differ between treatments. Adverse events were significantly more likely under danazol when compared with progestogen treatment. Change in quality of life was not significantly different with progestogen and tranexamic acid therapy but there was a non-significant trend in favour of tranexamic acid for all three categories. Progestogen therapy administered from day 5 to 26 of the menstrual cycle was significantly less effective at reducing menstrual blood loss than the progestogen releasing intrauterine system (LNG IUS) although the reduction from baseline was significant for both groups. The odds of the menstrual period becoming "normal" (ie <80mls/cycle) were also less likely in patients treated with norethisterone (NET) (days 5 to 26) compared to patients treated with LNG IUS. A significantly higher proportion of NET patients found their treatment unacceptable compared to LNG IUS patients. However, the adverse events breast tenderness and intermenstrual bleeding were more likely in the patients with the IUS. (ABSTRACT TRUNCATED)

Administration, Oral↗

Seclusion and restraint for people with serious mental illnesses.

BACKGROUND: Seclusion and restraint are interventions used in the treatment and management of disruptive and violent behaviours in psychiatry. The use of seclusion varies widely across institutions. The literature does offer numerous suggestions for interventions to reduce or prevent aggression. OBJECTIVES: 1. To estimate the effects of seclusion and restraint compared to the alternatives for those with serious mental illnesses. 2. To estimate the effects of strategies to prevent seclusion and restraint in those with serious mental illnesses. SEARCH STRATEGY: Electronic searches of The Cochrane Controlled Trials Register (Issue 1, 1999) and The Cochrane Schizophrenia Group's Register (January 1999) were supplemented with additional searches of Biological Abstracts (1989-1999), CINAHL (1982-1999), EMbase (1980-1999), MEDLINE (1966-1999), MEDIC (1979-1999), PsycLIT (1974-1999), Sociofile (1974-1999), SPRI & SWEMED (1982-1999), Social Sciences Citation Index (1996-1999), and WILP (1983-1999). In addition, trials were sought by hand searching the reference lists of all identified studies and conference abstracts and contacting the first author of each relevant study. SELECTION CRITERIA: Randomised controlled trials were included if they focused on the use (i) of restraint or seclusion; or (ii) of strategies designed to reduce the need for restraint or seclusion in the treatment of serious mental illness. DATA COLLECTION AND ANALYSIS: Studies were reliably selected, quality rated and data extracted. For dichotomous data relative risks (RR) with 95% confidence intervals (CI) were estimated. Normal continuous data were summated using the weighted mean difference (WMD). MAIN RESULTS: 1. Effect of seclusion and restraint The search strategy yielded 2155 citations. Of these, the full articles for 35 studies were obtained. No studies met minimum inclusion criteria and no data were synthesised. Most of the 24 excluded studies focused upon the restraint of elderly, confused people and preventing them from wandering or falling. 2. Prevention of seclusion and restraint Work ongoing. REVIEWER'S CONCLUSIONS: No controlled studies exist that evaluate the value of seclusion or restraint in those with serious mental illness. There are reports of serious adverse effects for these techniques in qualitative reviews. Alternative ways of dealing with unwanted or harmful behaviours need to be developed. Continuing use of seclusion or restraint must therefore be questioned from within well-designed and reported randomised trials that are generalisable to routine practice.

Antipsychotic Agents↗

Substitution of doctors by nurses in primary care.

BACKGROUND: Demand for primary care services has increased in developed countries due to population ageing, rising patient expectations, and reforms that shift care from hospitals to the community. At the same time, the supply of physicians is constrained and there is increasing pressure to contain costs. Shifting care from physicians to nurses is one possible response to these challenges. The expectation is that nurse-doctor substitution will reduce cost and physician workload while maintaining quality of care. OBJECTIVES: Our aim was to evaluate the impact of doctor-nurse substitution in primary care on patient outcomes, process of care, and resource utilisation including cost. Patient outcomes included: morbidity; mortality; satisfaction; compliance; and preference. Process of care outcomes included: practitioner adherence to clinical guidelines; standards or quality of care; and practitioner health care activity (e.g. provision of advice). Resource utilisation was assessed by: frequency and length of consultations; return visits; prescriptions; tests and investigations; referral to other services; and direct or indirect costs. SEARCH STRATEGY: The following databases were searched for the period 1966 to 2002: Medline; Cinahl; Bids, Embase; Social Science Citation Index; British Nursing Index; HMIC; EPOC Register; and Cochrane Controlled Trial Register. Search terms specified the setting (primary care), professional (nurse), study design (randomised controlled trial, controlled before-and-after-study, interrupted time series), and subject (e.g. skill mix). SELECTION CRITERIA: Studies were included if nurses were compared to doctors providing a similar primary health care service (excluding accident and emergency services). Primary care doctors included: general practitioners, family physicians, paediatricians, general internists or geriatricians. Primary care nurses included: practice nurses, nurse practitioners, clinical nurse specialists, or advanced practice nurses. DATA COLLECTION AND ANALYSIS: Study selection and data extraction was conducted independently by two reviewers with differences resolved through discussion. Meta-analysis was applied to outcomes for which there was adequate reporting of intervention effects from at least three randomised controlled trials. Semi-quantitative methods were used to synthesize other outcomes. MAIN RESULTS: 4253 articles were screened of which 25 articles, relating to 16 studies, met our inclusion criteria. In seven studies the nurse assumed responsibility for first contact and ongoing care for all presenting patients. The outcomes investigated varied across studies so limiting the opportunity for data synthesis. In general, no appreciable differences were found between doctors and nurses in health outcomes for patients, process of care, resource utilisation or cost. In five studies the nurse assumed responsibility for first contact care for patients wanting urgent consultations during office hours or out-of-hours. Patient health outcomes were similar for nurses and doctors but patient satisfaction was higher with nurse-led care. Nurses tended to provide longer consultations, give more information to patients and recall patients more frequently than did doctors. The impact on physician workload and direct cost of care was variable. In four studies the nurse took responsibility for the ongoing management of patients with particular chronic conditions. The outcomes investigated varied across studies so limiting the opportunity for data synthesis. In general, no appreciable differences were found between doctors and nurses in health outcomes for patients, process of care, resource utilisation or cost. AUTHORS' CONCLUSIONS: The findings suggest that appropriately trained nurses can produce as high quality care as primary care doctors and achieve as good health outcomes for patients. However, this conclusion should be viewed with caution given that only one study was powered to assess equivalence of care, many studies had methodological limitations, and patient follow-up was generally 12 months or less. While doctor-nurse substitution has the potential to reduce doctors' workload and direct healthcare costs, achieving such reductions depends on the particular context of care. Doctors' workload may remain unchanged either because nurses are deployed to meet previously unmet patient need or because nurses generate demand for care where previously there was none. Savings in cost depend on the magnitude of the salary differential between doctors and nurses, and may be offset by the lower productivity of nurses compared to doctors.

Family Practice↗

Local oestrogen for vaginal atrophy in postmenopausal women.

BACKGROUND: Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for these symptoms in the form of oral hormone replacement therapy is not always necessary. An alternative choice is oestrogenic preparations administered vaginally (in the form of creams, pessaries, tablets and the estradiol releasing ring). OBJECTIVES: The objective of this review is to compare the effectiveness, safety and acceptability of oestrogenic preparations for women who suffer from vaginal atrophy. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group register of trials (searched January 2003), The Cochrane Library (Issue 2, 2003), MEDLINE (1966-January 2003), EMBASE (1980-January 2003), Current Contents (1993-January 2003), Biological Abstracts (1969-2002), Social Sciences Index (1980-January 2003), PsycINFO (1972-February 2003), CINAHL (1982-January 2003) and reference list of articles. We also contacted manufacturers and researchers in the field. SELECTION CRITERIA: The inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for the treatment of symptoms resulting from vaginal atrophy or vaginitis. DATA COLLECTION AND ANALYSIS: Twenty nine trials were identified, of these 13 were excluded. Trials were assessed for quality and two reviewers extracted data independently. Ratios for dichotomous and means for continuous outcomes were estimated. Outcomes analysed were included under the headings of efficacy, safety and acceptability. MAIN RESULTS: Sixteen trials with 2129 women were included in this review. The overall quality of the studies was good, although not all trials measured the same outcomes. All trials measured efficacy with various outcome measures. When comparing efficacy of oestrogenic preparations (in the form of creams, pessaries, tablets and the estradiol releasing vaginal ring) with each other in relieving the symptoms of vaginal atrophy, results indicated significant differences favouring the cream, ring, and tablets when compared to placebo and non-hormonal gel. Fourteen trials compared safety. Four looked at hyperplasia, four looked at endometrial overstimulation and six looked at adverse effects. One trial showed significant adverse effects of cream (conjugated equine oestrogen) when compared to tablets (estradiol) which included uterine bleeding, breast pain and perineal pain (1 RCT; OR 0.18, 95% CI 0.07 to 0.50). Two trials showed significant endometrial overstimulation as evaluated by progestagen challenge test in the cream (conjugated equine oestrogen) group when compared to the ring (OR 0.29, 95% CI 0.11 to 0.78). Although not statistically significant there was a 2% incidence of simple hyperplasia in the ring group when compared to cream (conjugated equine oestrogen) and 4% incidence of hyperplasia (one simple, one complex) in the cream group (conjugated equine oestrogen) when compared to the tablet (estradiol). Nine studies compared acceptability to the participants by comparing comfort of product, ease of use, overall product rating, delivery system and satisfaction. Results showed a significant preference for the estradiol releasing vaginal ring. REVIEWER'S CONCLUSIONS: Creams, pessaries, tablets and the estradiol vaginal ring appeared to be equally effective for the symptoms of vaginal atrophy. One trial found significant side effects noted following cream (conjugated equine oestrogen) administration when compared to tablets causing uterine bleeding, breast pain and perineal pain. Another trial found significant endometrial overstimulation following cream (conjugated equine oestrogen) when compared to the ring. As a treatment choice women appeared to favour the estradiol releasing vaginal ring for ease of use, comfort of product and overall satisfaction.

Administration, Intravaginal↗

Local oestrogen for vaginal atrophy in postmenopausal women.

BACKGROUND: Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for these symptoms in the form of oral hormone replacement therapy is not always necessary. An alternative choice is oestrogenic preparations administered vaginally (in the form of creams, pessaries, tablets and the oestradiol-releasing ring). OBJECTIVES: The objective of this review was to compare the effectiveness, safety and acceptability of oestrogenic preparations for women who suffer from vaginal atrophy. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Register of trials (searched January 2006), The Cochrane Library (2006,Issue 2), MEDLINE (1966 to January 2006), EMBASE (1980 to January 2006), Current Contents (1993 to January 2006, Biological Abstracts (1969 to 2006), Social Sciences Index (1980 to January 2006), PsycINFO (1972 to February 2006), CINAHL (1982 to January 2006) and reference list of articles. We also contacted manufacturers and researchers in the field. SELECTION CRITERIA: The inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for the treatment of symptoms resulting from vaginal atrophy or vaginitis. DATA COLLECTION AND ANALYSIS: Thirty-seven trials were identified: of these 18 were excluded. Included trials were assessed for quality and two reviewer authors extracted data independently. The ratios for dichotomous outcomes and means for continuous outcomes were calculated. The outcomes analysed were categorised under the headings of: efficacy, safety and acceptability. MAIN RESULTS: Nineteen trials with 4162 women were included in this review. The overall quality of the studies was good, although not all trials measured the same outcomes. All trials measured efficacy, with various outcome measures. When comparing the efficacy of different oestrogenic preparations (in the form of creams, pessaries, tablets and the oestradiol-releasing vaginal ring) in relieving the symptoms of vaginal atrophy, results indicated significant findings favouring the cream, ring, and tablets when compared to placebo and non-hormonal gel. Fourteen trials compared safety. Four looked at hyperplasia, four looked at endometrial overstimulation and seven looked at adverse effects. One trial showed significant adverse effects of the cream (conjugated equine oestrogen) when compared to tablets (oestradiol) which included uterine bleeding, breast pain and perineal pain (1 RCT; OR 0.18, 95% CI 0.07 to 0.50). Two trials showed significant endometrial overstimulation as evaluated by a progestagen challenge test with the cream (conjugated equine oestrogen) group when compared to the ring (OR 0.29, 95% CI 0.11 to 0.78). Although not statistically significant there was a 2% incidence of simple hyperplasia in the ring group when compared to the cream (conjugated equine oestrogen) and 4% incidence of hyperplasia (one simple, one complex) in the cream group (conjugated equine oestrogen) when compared to the tablet (oestradiol). Eleven studies compared acceptability to the participants by comparing: comfort of product use, ease of use, overall product rating, delivery system and satisfaction. Results showed a significant preference for the oestradiol-releasing vaginal ring. AUTHORS' CONCLUSIONS: Creams, pessaries, tablets and the oestradiol vaginal ring appeared to be equally effective for the symptoms of vaginal atrophy. One trial found significant side effects following cream (conjugated equine oestrogen) administration when compared to tablets causing uterine bleeding, breast pain and perineal pain. Another trial found significant endometrial overstimulation following use of the cream (conjugated equine oestrogen) when compared to the ring. As a treatment choice women appeared to favour the oestradiol-releasing vaginal ring for ease of use, comfort of product and overall satisfaction.

Administration, Intravaginal↗

Interventions for promoting the initiation of breastfeeding.

BACKGROUND: Despite the widely documented health benefits of breastfeeding, initiation rates remain relatively low in many high-income countries, particularly among women in lower income groups. OBJECTIVES: To evaluate the effectiveness of interventions which aim to encourage women to breastfeed in terms of changes in the number of women who start to breastfeed. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (30 May 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2003) and the following databases from inception to October 2002: MEDLINE, CINAHL, ERIC, Applied Social Sciences, PsychLIT, EMBASE, British Nursing Index, BIDS, EPI-centre. We also searched the following in October 2002 for 'grey literature: 'SIGLE, DHSS Data, and Dissertation Abstracts. We handsearched the Journal of Human Lactation, Health Promotion International and Health Education Quarterly from inception to October 1998. We scanned reference lists of all articles obtained. SELECTION CRITERIA: Randomised controlled trials, with or without blinding, of any breastfeeding promotion intervention in any population group except women and infants with a specific health problem. DATA COLLECTION AND ANALYSIS: One review author independently extracted data and assessed trial quality for checking by a second author. We contacted investigators to obtain missing information. MAIN RESULTS: Seven trials involving 1388 women were included. Five trials involving 582 women on low incomes in the USA showed breastfeeding education had a significant effect on increasing initiation rates compared to routine care (relative risk (RR) 1.53, 95% confidence interval (CI) 1.25 to 1.88). AUTHORS' CONCLUSIONS: Evidence from this review shows that the forms of breastfeeding education evaluated were effective at increasing breastfeeding initiation rates among women on low incomes in the USA.

Breast Feeding↗

Interventions for promoting smoke alarm ownership and function.

BACKGROUND: Residential fires caused at least 67 deaths and 2,500 non-fatal injuries to children aged 0-16 in the United Kingdom in 1998. Smoke alarm ownership is associated with a reduced risk of residential fire death. OBJECTIVES: We evaluated interventions to promote residential smoke alarms, to assess their effect on smoke alarm ownership, smoke alarm function, fires and burns and other fire-related injuries. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Cochrane Injuries Group database, MEDLINE, EMBASE, PsycLIT, CINAHL, ERIC, Dissertation Abstracts, International Bibliography of Social Sciences, ISTP, FIREDOC and LRC. Conference proceedings, published case studies, and bibliographies were systematically searched, and investigators and relevant organisations were contacted, to identify trials. SELECTION CRITERIA: Randomised, quasi-randomised or nonrandomised controlled trials completed or published after 1969 evaluating an intervention to promote residential smoke alarms. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: We identified 26 trials, of which 13 were randomised. Overall, counselling and educational interventions had only a modest effect on the likelihood of owning an alarm (OR=1.26; 95% CI: 0.87 to 1.82) or having a functional alarm (OR=1.19; 0.85 to 1.66). Counselling as part of primary care child health surveillance had greater effects on ownership (OR=1.96; 1.03 to 3.72) and function (OR=1.72; 0.78 to 3.80). Results were sensitive to trial quality, however, and effects on fire-related injuries were not reported. In two non randomised trials, direct provision of free alarms significantly increased functioning alarms and reduced fire-related injuries. Media and community education showed little benefit in non randomised trials. REVIEWER'S CONCLUSIONS: Counselling as part of child health surveillance may increase smoke alarm ownership and function, but its effects on injuries are unevaluated. Community smoke alarm give-away programmes apparently reduce fire-related injuries, but these trials were not randomised and results must be interpreted cautiously. Further efforts to promote smoke alarms in primary care or through give-away programmes should be evaluated by adequately designed randomised controlled trials measuring injury outcomes.

Burns↗

Interventions for preventing eating disorders in children and adolescents.

BACKGROUND: Eating disorders represent an extremely difficult condition to treat and patients consume an enormous amount of mental health energy and resources. Being young, female, and dieting are some of the few identified risk factors that have been reliably linked to the development of eating disorders, and several prevention eating disorder prevention programs have been developed and trialed with children and adolescents. The purpose of this systematic review is to evaluate the effectiveness of eating disorder prevention programs for children and adolescents both in the general population and those determined to be at risk. OBJECTIVES: 1. To determine if eating disorder prevention programs are effective in promoting healthy eating attitudes and behaviours in children and adolescents; 2. To determine if eating disorder prevention programs are effective in promoting psychological factors that protect children and adolescents from developing eating disorders; 3. To determine if eating disorder prevention programs are effective in promoting satisfactory physical health in children and adolescents; 4. To determine if eating disorder prevention programs have a long-term, sustainable, and positive impact on the mental and physical health of children and adolescents; and, 5. To determine the safety of eating disorder prevention programs in terms of possible harmful consequences on the mental or physical health of children and adolescents. SEARCH STRATEGY: Relevant trials are identified through searching the Cochrane Controlled Trial Register (CCTR) and relevant biomedical and social science databases. All terms necessary to detect prevention programs and the participant groups are used. A strategy to locate randomised controlled trials is used. Other sources of information are the bibliographies of systematic and non-systematic reviews and reference lists from articles identified through the search strategy. In order to identify unpublished studies, experts in the field are contacted by letter and/or electronic mail. SELECTION CRITERIA: Randomised controlled trials (RCT) with a major focus on eating disorder prevention programs for children and adolescents, where there is no known DSM-IV diagnosis of an eating disorder, are eligible for inclusion in the review. Trials must include a control group and at least one objective outcome measure (eg. BMI) or a standardised psychological measure used with the intervention and control group, pre- and post-intervention. DATA COLLECTION AND ANALYSIS: A total of 1379 titles have been identified through the search to date. 13 studies were located that reported use of a randomised controlled trial methodology and were critically appraised by two independent reviewers. Five (5) studies were excluded as data were not reported in a useable form or useable data could not be obtained from the trial authors, one dissertation could not be obtained, one study had no "true" no-treatment or usual treatment control group, and one study did not use a pre-test outcome measure. Eight (8) studies met the selection criteria outlined above. MAIN RESULTS: Only one of eight pooled comparisons of two or more studies using similar outcome measures and similar intervention types demonstrated the statistically significant effect of a particular type of eating disorder prevention program for children and adolescents. Combined data from two eating disorder prevention programs based on a media literacy and advocacy approach indicate a reduction in the internalisation or acceptance of societal ideals relating to appearance at a 3- to 6-month follow-up (Kusel, unpublished; Neumark-Sztainer2000) [SMD -0.28, -0.51 to -0.05, 95% CI]. However, there is insufficient evidence to conclude that this approach also demonstrated a significant impact on awareness of societal standards relating to appearance. There is insufficient evidence to support the effect of four programs designed to address eating attitudes and behaviours and other adolescent issues on body weight, eating disorder symptoms, associated eating disorder psychopathology or general psychological and physical well-being in the general sample or those classified as being at high risk for eating disorder (Buddeberg-F 1998; Killen 1993/1996; Santonastaso 1999; Zanetti 1999). Given only one program used a psychoeducation approach to prevent bulimia nervosa (Jerome, unpublished) and only one program adopted a focus on self-esteem (O'Dea 2000), the effect of these approaches could not be evaluated via meta-analyses. In relation to potential harmful effects, there is not sufficient evidence to suggest that harm resulted from any of the prevention programs included in the review. REVIEWER'S CONCLUSIONS: The one significant pooled effect in the current review does not allow for any firm conclusions to be made about the impact of prevention programs for eating disorders in children and adolescents, although none of the pooled comparisons indicated evidence of harm. From a clinical perspective, the development and refinement of prevention programs is complicated by a lack of knowledge about risk factors associated with eating disorders and the need to strike a balance between delivering preventive interventions for eating disorders and considering the potential to cause harm. From a research perspective, the idea of "thresholds" for identifying young people at risk of developing eating disorders has been raised, and denial of concern or denial of illness represents a further issue complicating early identification in relation to eating disorder symptomatology. Longer-term effects of the intervention approaches will need to be monitored across development in order to demonstrate a decline in the incidence of eating disorders and associated risk factors.

Adolescent↗

Strategies for integrating primary health services in middle- and low-income countries: effects on performance, costs and patient outcomes.

BACKGROUND: Integration of primary health care is change to bring together inputs, organisation, management and delivery of particular service functions. Integration has been promoted in the health sector to improve the efficiency of health care delivery. The need for integration arose from perceptions that services were fragmented when delivered through separate vertical programmes. Integration is relevant to the health system at various levels, and this review is concerned with integration at the point of delivery. OBJECTIVES: To assess the effects of strategies to integrate primary health care services on producing a more coherent product and improving health care delivery and health status, in relation to service cost, outputs, impact and user acceptability. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register (August 2000), MEDLINE (1966 to September 2000), EMBASE (1988 to September 2000), Socio Files (1974 to September 2000), Popline (1970 to September 2000), HealthStar (1975 to September 2000), Cinahl (1982 to September 2000); Cab Health (1972 to 1999), International Bibliography of the Social Sciences (1970 to 1999), and reference lists of articles. We also searched the Internet and World Health Organization (WHO) library database, hand searched relevant WHO publications and contacted experts in the field. SELECTION CRITERIA: Randomised trials, controlled before and after studies, and interrupted time series analyses of integration strategies in primary health care services. Health services in high-income countries were excluded. The primary outcomes were service outputs: productivity and coverage, impact, user acceptability and unit cost. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Four studies were included. There was no consistent pattern of benefit. Integration had a clear positive effect on the outputs in only one study; in another it had similar effects to vertical programme delivery but greater effect than the control group. In the other two studies integration resulted in negative outputs in comparison with vertical programmes, although in one of these integration performed better than the control group. REVIEWER'S CONCLUSIONS: Few studies of good quality, large and with rigorous study design have been carried out to investigate the evidence to support integration as a style of service delivery. In fact, some studies found greater effects for vertical health care delivery. Policy makers and planners considering integration could introduce strategies, using rigorous study design, to allow further evaluation and increase the base of studies from which to draw evidence.

Clinical Trials as Topic↗

Strategies for integrating primary health services in middle- and low-income countries at the point of delivery.

BACKGROUND: Strategies to integrate primary health care aim to bring together inputs, organisation, management and delivery of particular service functions to make them more efficient, and accessible to the service user. In some middle and low income countries, services have been fragmented by separate vertical programmes established to ensure delivery of particular technologies. We examined the effectiveness of integration strategies at the point of delivery. OBJECTIVES: To assess the effects of strategies to integrate primary health care services on producing a more coherent product and improving health care delivery and health status. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register (August 2005), MEDLINE (1966 to September 2005), EMBASE (1988 to 2005), Socio Files (1974 to September 2005), Popline (1970 to September 2005), HealthStar (1975 to September 2005), Cinahl (1982 to September 2005); Cab Health (1972 to 1999), International Bibliography of the Social Sciences (1970 to 1999), and reference lists of articles. We also searched the Internet and World Health Organization (WHO) library database, hand searched relevant WHO publications and contacted experts in the field. SELECTION CRITERIA: Randomised trials, controlled before and after studies, and interrupted time series analyses of integration strategies in primary health care services. Health services in high-income countries were excluded. The primary outcomes were indicators of health care delivery, user views on any measure of service coherence, and health status. We also sought information on comparative costs. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed study quality. MAIN RESULTS: Three cluster randomised trials and two controlled before and after studies were included, with three types of comparison: integration by adding on an additional component to an existing service (family planning); integrated services versus single special services (for sex workers); integrated delivery systems versus a vertical service (for family planning); and packages of enhanced primary child care services (integrated management of childhood illnesses) vs. routine child care. Interventions were complex and in some studies inputs varied substantially between comparison arms. Overall, no consistent pattern emerged. Only one study attempted to assess the user's view of the service provided. AUTHORS' CONCLUSIONS: Few studies of good quality, large and with rigorous study design have been carried out to investigate strategies to promote service integration in low and middle income countries. All describe the service supply side, and none examine or measure aspects of the demand side. Future studies must also assess the client's view, as this will influence uptake of integration strategies and their effectiveness on community health.

Child↗

Psychological therapies for the management of chronic and recurrent pain in children and adolescents.

BACKGROUND: An increasing number of children suffer with pain that lasts for six months or longer. Traditional treatment for such pain has been pharmacological and/or physical. Increasingly, following developments in the field of adult chronic pain management, psychological therapies are being employed to treat children with chronic or recurrent pain. OBJECTIVES: To assess the effectiveness of psychological therapies in treating chronic or recurrent pain in children and adolescents, and to test the null hypothesis that psychological therapies are no more effective than placebo, waiting list control or standard medical care. SEARCH STRATEGY: Electronic searches of the Cochrane Register of Randomised Controlled Trials, MEDLINE (1966-1999), Social Sciences Citation Index (1981-1999) and PsycLit (1974-1999) were made. RCTs were also sought in references of all identified studies, meta-analyses and reviews, and first authors and experts within the field were contacted. Date of the most recent search: December 1999. SELECTION CRITERIA: RCTs with at least five participants in each study arm which compared psychological therapies with placebo, waiting list or standard medical care for children or adolescents with chronic or recurrent pain were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Data were inspected for heterogeneity. For homogeneous dichotomous data the odds ratio with 95% confidence interval were calculated on an intention to treat basis. MAIN RESULTS: Thirty papers were recovered, representing 28 RCTs. Of these, 18 were analysable and included a total of 808 patients, 438 of whom entered treatment conditions. Fifteen were trials of chronic or recurrent headache; two for recurrent abdominal pain; and one for sickle cell pain. Only pain experience data from 13 trials were meta-analysable. Two meta-analyses were conducted. The first analysis of single treatments versus controls gave a pooled odds ratio of 8.83 (95% CI 4.33 to 18.03; z=5.98, P < 0.00001, df = 12 ). The second analysis (combined treatment versus control) produced a similar estimate: pooled odds ratio = 8.64 ( 95% CI = 4.13 to 18.07; z-5.73, P < 0.00001, df = 9 ). Both analyses indicate that psychological treatment is effective when compared with a pooled group of control conditions. From the pooled data set the NNT was 2.32 (95%CI 1.96 to 2.88). REVIEWER'S CONCLUSIONS: There is very good evidence that psychological treatments, principally relaxation and cognitive behavioural therapy, are effective in reducing the severity and frequency of chronic headache in children and adolescents. There is at present no evidence for the effectiveness of psychological therapies in attenuating pain in conditions other than headache, and little evidence for the effectiveness of psychological therapies in improving non-pain outcomes.

Abdominal Pain↗

Setting and organization of care for persons living with HIV/AIDS.

BACKGROUND: Treating the world's 40.3 million persons currently infected with HIV/AIDS is an international responsibility that involves unprecedented organizational challenges. Key issues include whether care should be concentrated or decentralized, what type and mix of health workers are needed, and which interventions and mix of programs are best. High volume centres, case management and multi-disciplinary care have been shown to be effective for some chronic illnesses. Application of these findings to HIV/AIDS is less well understood. OBJECTIVES: Our objective was to evaluate the association between the setting and organization of care and outcomes for people living with HIV/AIDS. SEARCH STRATEGY: Computerized searches from January 1, 1980 to December 31, 2002 of MEDLINE, EMBASE, Dissertation Abstracts International (DAI), CINAHL, HealthStar, PsychInfo, PsychLit, Social Sciences Abstracts, and Sociological Abstracts as well as searches of meeting abstracts and relevant journals and bibliographies in articles that met inclusion criteria. Searches included articles published in English and other languages. SELECTION CRITERIA: Articles were considered for inclusion if they were observational or experimental studies with contemporaneous comparison groups of adults and/or children currently infected with HIV/AIDS that examined the impact of the setting and/or organization of care on outcomes of mortality, opportunistic infections, use of HAART and prophylaxis, quality of life, health care utilization, and costs for patient with HIV/AIDS. DATA COLLECTION AND ANALYSIS: Two authors independently screened abstracts to determine relevance. Full paper copies were reviewed against the inclusion criteria. The findings were extracted by both authors and compared. The 28 studies that met inclusion criteria were too disparate with respect to populations, interventions and outcomes to warrant meta-analysis. MAIN RESULTS: Twenty-eight studies were included involving 39,776 study subjects. The studies indicated that case management strategies and higher hospital and ward volume of HIV-positive patients were associated with decreased mortality. Case management was also associated with increased receipt of ARVs. The results for multidisciplinary teams or multi-faceted treatment varied. None of the studies examined quality of life or immunological or virological outcomes. Healthcare utilization outcomes were mixed. AUTHORS' CONCLUSIONS: Certain settings of care (i.e. high volume of HIV positive patients) and models of care (i.e. case management) may improve patient mortality and other outcomes. More detailed descriptions of care models, consistent definition of terms, and studies on innovative models suitable for developing countries are needed. There is not yet enough evidence to guide policy and clinical care in this area.

Acquired Immunodeficiency Syndrome↗

Community-based supplementary feeding for promoting the growth of young children in developing countries.

BACKGROUND: Supplementary feeding is defined as the provision of extra food to poor children or families beyond the normal ration of their home diets. The impact of food supplementation on child growth merits careful evaluation in view of the reliance of many states and NGOs on this intervention to improve child health in developing countries. OBJECTIVES: To evaluate the effectiveness of community-based supplementary feeding for promoting the physical growth of pre-school children in developing countries. SEARCH STRATEGY: Searches of CENTRAL 2005 (Issue 2), MEDLINE 1966 to 2005, EMBASE 1980 to 2005, CINAHL 1982 to 2005, LILACS 1982 to 2005, Social Science Citation Index 1956 to 2005, and Dissertation Abstracts International (late 1960s to 2005) were conducted. SELECTION CRITERIA: Randomised controlled trials evaluating supplementary feeding in children aged 0-5 years old in developing countries. DATA COLLECTION AND ANALYSIS: Data were extracted and analysed independently by two authors. MAIN RESULTS: Four trials met the inclusion criteria for this review. No meta-analysis is currently appropriate due to the clinical heterogeneity among the included studies. We group these trials into two categories: a) studies without formally assessment of malnourishment at baseline and, b) studies involving children formally assessed as malnourished.a) A cluster RCT conducted in Indonesia in 1991(20 Day Care Centres, n = 113 children), found no benefit in weight-for-age and height-for-age z-scores of the intervention group compared to the control group after three months of intervention. A study in Guatemala included four villages as unit of analysis (exact sample sizes were not provided). The length of 3-yr-old children was based on a 'before-after comparison' by village size and type of supplement. According to this analysis, the difference in net change in the large villages was 2.55 cm and in the small villages was 2.35 cm. The mean of these differences is 2.45 +- 0.10 cm (mean +- SD).b) A study conducted in Jamaica (n = 65 children) reported a positive effect on length (cm) in the supplemented group compared to controls [WMD 1.3 (0.03 to 2.57)] after 12 months of intervention. A trial from Indonesia (n = 75 children) found no benefit in growth after 12 months of supplementation. AUTHORS' CONCLUSIONS: Based on the small number of available trials, no firm conclusions of the effectiveness of supplementary feeding to the growth of pre-school children could be drawn. Issues of research design such as blinding and sample size calculation need to be addressed in future studies.

Child↗

In defense of a critical-presentist historiography: the fact-theory relationship and Marx's epistemology.

It is argued that mainstream social scientists made an "error" during the crucial formative years of the 1920s and 1930s. This historical error involved relinquishing, or at the very least ignoring, some of the epistemological views within the social sciences concerning the fact-theory relationship as developed by Marx and others in his tradition. The contemporary nature of some of Mark's epistemic views is demonstrated, where the case is made that some recent developments in the philosophy of science are converging with some of his original insights. The methodological approach of the article--judging the past in the context of the present--is defended on the basis of Marxian historiography, especially as developed by those noe-Marxists of the Frankfurt School. In the latter discussion "justificationist presentism" is criticized from the perspective of a "critical presentism."

Famous Persons↗

The rights of research assistants and the rhetoric of political suppression: Morton Grodzins and the University of California Japanese-American Evacuation and Resettlement Study.

This case study of an inter-university controversy over the publication of research from an interdisciplinary social science project on the forced migration and long-term internment of West Coast Japanese-Americans during World War II shows some of the difficulties of maintaining ownership of research materials. In this particular instance the junior employee was able to override his seniors' demand for control of the dissemination of research results by playing on the concerns about even appearing to suppress work for political reasons. The paper discusses conflicting norms of science and rhetorics of justification ranging from proprietary self-interest through "good science" to "the national interest" and onto "the needs of a free society."

Asian↗

Child abuse and the balance of power in parental relationships: an evolved domain-independent mental mechanism that accounts for behavioral variation.

Previous studies use zero-order analyses to show a link between child abuse and exposure to "stepfathers." These studies rest on a proposed evolved, domain-specific cognitive mechanism that induces adult males to abuse or kill offspring not their own and, so, contribute directly to reproductive success. However, child abuse may reflect an evolved neurological mechanism that creates behavioral plasticity and adaptability by assigning emotional weights (which in consciousness appear rationalized as costs and benefits) to choice alternatives in all behavioral domains. This mechanism should act as a selective mechanism to create enhanced ability to avoid predation (social exploitation) and to obtain access to resources, given the properties of specific ecosystems, and should control behavioral responses to variation in the balance of power in social relationships. Power equalities should elicit good treatment for both parties; power inequalities, by contrast, should elicit exploitative and coercive behavior on the part of those who hold the balance of power. This paper reports a test of both hypotheses simultaneously, controlling for a standard social science risk factor (growing up in poverty). Once we control for the balance of power in parental relationships, exposure to a stepfather and growing up in poverty show no effect on the intensity of child abuse. Powerful women negotiated affectionate behavior from their partners for both themselves and their children; powerless women's negotiations with partners usually left both themselves and their children open to violence.

Adult↗