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Cochrane Controlled Trials Register (cochrane + control_trials_register)
Selected AbstractsEffectiveness of brief structured interventions on risk factor modification for patients with coronary heart disease: a systematic reviewINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 4 2007Ritin Fernandez RN MN (Critical care) PhD Candidate Abstract Background, The physical and psychosocial benefits of participation in cardiac rehabilitation following a coronary event have well been established. Despite these benefits there is strong evidence that participation in traditional cardiac rehabilitation programs remains low. Various models of cardiac rehabilitation have been implemented including the use of brief structured interventions to enable modification of coronary risk factors. Objectives, The objective of this review was to determine the effect of brief structured interventions on risk factor modification in patients with coronary heart disease. Search strategy, A literature search was performed using the following databases MEDLINE (1966,2006), CINAHL (1982,2006), EMBASE (1980,current) and up to the Cochrane Controlled Trials Register (Issue 2, 2006 of Cochrane Library). In addition, the reference lists of relevant trials and conference proceedings were also scrutinised. Company representatives, experts and investigators were contacted to elicit further information. Selection criteria, All randomised and quasi-randomised controlled trials that compared the effects of brief structured interventions on risk factor modification in patients with coronary heart disease were considered for inclusion in the review. Data collection and analysis, Eligibility of the trials for inclusion in the review, details of eligible trials and the methodological quality of the trials were assessed independently by two reviewers. Relative risks for dichotomous data and a weighted mean difference for continuous data were calculated with 95% confidence intervals. Where synthesis was inappropriate, trials were considered separately. Main results, Seventeen trials involving a total of 4725 participants were included in the final review: three trials compared the effects of brief structured interventions on diet modification; seven on smoking cessation; and seven on multiple risk factors. Two trials involving 76 patients compared brief structured intervention versus usual care for dietary modification. Although there was a tendency for more participants in the intervention arm to lose weight at the 12-week follow up and achieve target cholesterol levels at the 6-month follow up, these results were not statistically significant. Only one small trial involving 36 patients compared brief structured intervention and extensive intervention for dietary modification and demonstrated a significant reduction in the percentage of energy obtained from fat and saturated fat intake among participants receiving extensive intervention. However, no difference in fish, fruit and vegetable intake between the groups was evident. Six trials involving 2020 patients compared brief structured intervention versus usual care for smoking cessation. There was no difference in the smoking cessation rates at the 3- and 6-week follow up, however, there was evidence of a benefit of brief structured interventions for smoking cessation at the 3-, 6- and 12-month follow up. In the only trial that and compared brief structured intervention and extensive intervention for smoking cessation in 254 participants there was no clear difference of a likelihood of smoking cessation between the two groups. In the seven trials that compared brief structured intervention and usual care for multiple risk factor modification there was evidence of a benefit of the intervention on behavioural changes such as fat intake, weight loss and consequently on reduction in the body mass index, smoking cessation and physical activity among the participants. The findings concerning the effect on blood pressure, blood glucose levels and the lipid profile, however, remain inconclusive. Conclusions, There is suggestive but inconclusive evidence from the trials of a benefit in the use of brief interventions for risk factor modification in patients with coronary heart disease. This review, however, supports the concept that brief interventions for patients with coronary heart disease can have beneficial effects on risk factor modification and consequently on progression of coronary heart disease. Further trials using larger sample sizes need to be undertaken to demonstrate the benefits of brief structured intervention targeted at the modification of single or multiple risk factors. [source] Effectiveness of general practice nurse interventions in cardiac risk factor reduction among adultsINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 3 2007Elizabeth Halcomb RN BN(Hons) Grad Cert. Abstract Background, Cardiovascular disease is the leading cause of death for adults in Australia. In recent years there has been a shift in health service delivery from institutional to community-based care for chronic conditions, including cardiovascular disease. The general practice setting is seen to offer greater flexibility, higher levels of efficiency and more client focused healthcare delivery than is possible in the acute care sector. It has been suggested that practice nurses represent a useful adjunct to current models of cardiovascular disease management. To date, significant descriptive research has been conducted exploring the demographics, roles, educational needs and issues facing practice nurses. However, there is a need to evaluate the effectiveness of practice nurse interventions in terms of patient outcomes, clinician satisfaction and cost-effectiveness. Objectives, This review seeks to present the best available evidence regarding the efficacy of general practice nurse interventions for cardiac risk factor reduction in healthy adults, as well as those with established cardiovascular disease or known cardiac risk factors. Search Strategy, A systematic literature search was performed using Medline (1966 , 2005), CINAHL (1982 ,2005), Cochrane Controlled Trials Register (Issue 4, 2005) and the Joanna Briggs Institute Evidence Library. In addition, the reference lists of retrieved papers, conference proceedings and the Internet, were scrutinised for additional trials. Selection Criteria, This review considered any English language randomised trials that investigated interventions conducted by the practice nurse for cardiovascular disease management or reduction of cardiac risk factors. Interventions conducted by specialist cardiac nurses in general practice were excluded. Outcomes measured included blood pressure, smoking cessation, total cholesterol, exercise, body weight/body mass index and cost-effectiveness. Results, Eighteen trials, reported in 33 papers, were included in the review. Ten trials investigated multifaceted interventions, while the remaining eight trials reported targeted interventions. Of the trials that reported multifaceted interventions, three trials investigated risk reduction in those with established cardiovascular disease, four trials focused on those with known cardiovascular disease risk factors and three trials included the general community. The eight trials which examined the efficacy of targeted interventions focused upon dietary intake (two trials), smoking cessation (three trials), weight reduction (one trial) and physical activity (two trials). The effect of both the multifaceted and targeted interventions on patient outcomes was variable. However, both the multifaceted and targeted interventions demonstrated similar outcome trends for specific variables. Improvements were demonstrated by most studies in blood pressure, cholesterol level, dietary intake and physical activity. The variation in outcome measures and contradictory findings between some studies makes it difficult to draw definitive conclusions. Conclusions, While interventions to reduce cardiovascular disease risk factors have produced variable results, they offer significant potential to assist patients in modifying their personal risk profile and should be developed. The public health importance of these changes is dependant upon the sustainability of the change and its effect on the health outcomes of these individuals. Further well-designed research is required to establish the effectiveness of practice nurse interventions for cardiovascular disease management and risk factor reduction in terms of patient outcomes and cost-effectiveness. [source] A systematic review of multivitamin and multimineral supplementation for infectionJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 3 2006A. I. Stephen Abstract Background, Infections are major causes of morbidity and mortality worldwide. Micronutrients have important functions in the body's immune system. This systematic review examined the evidence from randomized controlled trials (RCTs) on whether multivitamin and multimineral supplementation is effective in reducing infection. Methods, Electronic databases searched: Cochrane Controlled Trials Register, EMBASE, MEDLINE, BIOSIS, CAB abstracts. Hand searching of nutrition journals and reference lists was carried out. RCTs and quasi-randomized trials of supplementation of adults with at least two vitamins or minerals or a combination were selected. Study results were combined in meta-analysis plots where appropriate. Results, Twenty studies were included in the review. Small numbers were available for each meta-analysis. Results are presented here without the Chandra group studies. No significant difference was found in the number of episodes of infection in older people (,65 years) between those supplemented and those not supplemented; (WMD) 0.06 [95% confidence interval (CI) ,0.04, 0.16], P = 0.25. In other adults groups, there were significantly less episodes of infection in those supplemented; (WMD) ,1.20 (95% CI ,2.08, ,0.32), P = 0.008. There was no significant difference between those older people supplemented and those not supplemented in the number with at least one infection; relative risk (RR) 0.98 (95% CI 0.86, 1.11), P = 0.77. Similarly, there was no significant difference in the numbers in other adult groups who had at least one episode of infection between those supplemented and those taking placebo; (RR) 0.81 (95% CI 0.65, 1.00), P = 0.06. Subgroup analyses suggested that supplemented people aged 65 years or over may benefit more if they are undernourished and supplemented for over 6 months, WMD ,0.67 infections (95% CI ,1.24, ,0.10), P = 0.02. Conclusion, Further large trials are needed, particularly in undernourished older people. Trials of supplementation periods of over 6 months are recommended. [source] Cisapride treatment for gastro-oesophageal reflux in children: A systematic review of randomized controlled trialsJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 6 2000R E Gilbert Abstract: The aim of the systematic review was to determine the effect of cisapride compared with placebo or other non-surgical therapies for the treatment of symptoms of gastro-oesophageal reflux in children. We searched MEDLINE, EMBASE, the Cochrane Controlled Trials Register, Science Citation Index and reference lists for randomized controlled trials which compared cisapride with placebo or other non-surgical therapy in children. We included only trials which reported reflux-related symptoms as an outcome, provided that cisapride was administered orally for at least 1 week. Seven trials (286 children in total) compared cisapride with placebo. Two trials reported good concealment of treatment allocation. The pooled odds ratio for the ,same or worse' symptoms was 0.34 (95%CI 0.10, 1.19). There was substantial heterogeneity between studies (P < 0.00001) and the funnel plot was asymmetrical. Adverse effects (mainly diarrhoea) were not significantly increased with cisapride (pooled odds ratio (OR) 1.80: 0.87, 3.70). The reflux index was significantly reduced in children treated with cisapride (weighted mean difference ,6.49: ,10.13, ,2.85). One study (50 children) compared cisapride with gaviscon plus carobel: the OR for the ,same or worse' symptoms was 3.26 (0.93, 11.38). There was no clear evidence that cisapride reduced symptoms of gastro-oesophageal reflux. As smaller, poorer quality studies were biased in favour of a positive treatment effect, the pooled OR overestimated the potential benefits of cisapride. There was some evidence to suggest that gaviscon plus carobel may be a more effective option than cisapride. [source] Artificial and bioartificial support systems for liver failure: a Cochrane Hepato-Biliary Group ProtocolLIVER INTERNATIONAL, Issue 5 2002Jianping Liu Abstract: Aims/Background: Liver support systems may bridge patients to liver transplantation or recovery from liver failure. This review is to evaluate the beneficial and harmful effects of artificial and bioartificial support systems for acute and acute-on-chronic liver failure. Data Sources: Randomized trials on any support system versus standard medical therapy will be included irrespective of publication status or language. Non-randomized studies are included in explorative analyses. Trials will be identified through bibliographies, correspondence with original investigators, and electronic searches (Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Controlled Trials Register, MEDLINE, EMBASE, and The Chinese Biomedical Database). Methods of the review: The extracted data will include characteristics of trials, patients, interventions, and all outcome measures. Methodological quality will be assessed by the randomization, follow up, and blinding. The RevMan and STATA will be used for statistical analyses. Sources of heterogeneity and methodological quality in the assessment of the primary outcome will be explored by sensitivity analyses and meta-regression. [source] Does stretching induce lasting increases in joint ROM?PHYSIOTHERAPY RESEARCH INTERNATIONAL, Issue 1 2002A systematic review Abstract Background and Purpose Stretching (that is, interventions that apply tension to soft tissues) induces increases in the extensibility of soft tissues, and is therefore widely administered to increase joint mobility and reverse contractures. However, it is not clear whether the effects of stretching are lasting. A systematic review was conducted to determine if stretching (either self-administered, administered manually by therapists or by some external device such as a splint) produces lasting increases in the mobility of joints not directly affected by surgery, trauma or disease processes. Method In order to determine the lasting effects of stretching, only studies that measured joint range of motion (ROM) at least one day after the cessation of stretching were included. MEDLINE (from 1966 to June 2000), EMBASE (from 1988 to June 2000), the Cochrane Controlled Trials Register and PEDro databases were searched, and citation tracking was used to identify randomized studies that met the inclusion criteria. Each study was rated by two independent assessors on the PEDro scale, which rated trials according to criteria such as concealed allocation, blinding and intention-to-treat analysis. Results Thirteen studies satisfied the inclusion criteria. All examined the effect of stretching (median number of stretch sessions = eight) on joint ROM in healthy subjects without functionally significant contractures. Four studies were of ,moderate' quality and the remaining nine were of ,poor' quality. The ,moderate' quality studies suggest that regular stretching increases joint ROM (mean increase in ROM = 8°;95% CI 6° to 9°) for more than one day after cessation of stretching and possibly that the effects of stretching are greater in muscle groups with limited extensibility. Conclusions The results of four ,moderate' quality studies show a convincing effect of stretching in people without functionally significant contracture. These findings require verification with high-quality studies. Lasting effects of intensive stretching programmes (for example, stretching applied for more than six weeks or for more than 20 minutes a day) or of stretching on people with functionally significant contracture have not yet been investigated with randomized studies. Copyright © 2002 Whurr Publishers Ltd. [source] Commercial Hospital Discharge Packs for Breastfeeding WomenBIRTH, Issue 1 2001J. K. Gupta A substantive amendment to this systematic review was last made on 23 March 1999. Cochrane reviews are regularly checked and updated if necessary. ABSTRACT Background: For centuries, there has been controversy around whether being upright (sitting, birthing stools, chairs, squatting) or lying down has advantages for women delivering their babies. Objectives: The objective of this review was to assess the benefits and risks of the use of different positions during the second stage of labour (i.e., from full dilatation of the cervix). Search strategy: Relevant trials are identified from the register of trials maintained by the Cochrane Pregnancy and Childbirth Group, and from the Cochrane Controlled Trials Register. Selection criteria: Trials were included which compared various positions assumed by pregnant women during the second stage of labour. Randomised and quasi-randomised trials with appropriate follow-up were included. Data collection and analysis: Trials were independently assessed for inclusion, and data extracted by the two authors. Disagreements would have been resolved by consensus with an editor. Meta-analysis of data is performed using the RevMan software. Main results: Results should be interpreted with caution as the methodological quality of the 18 trials was variable. Use of any upright or lateral position, compared with supine or lithotomy positions, was associated with: 1Reduced duration of second stage of labour (12 trials,mean 5.4 minutes, 95% confidence interval (CI) 3.9,6.9 minutes). This was largely due to a considerable reduction in women allocated to use of the birth cushion. 2A small reduction in assisted deliveries (17 trials,odds ratio (OR) 0.82, 95% CI 0.69,0.98). 3A reduction in episiotomies (11 trials,OR 0.73, 95% CI 0.64,0.84). 4A smaller increase in second degree perineal tears (10 trials,OR 1.30, 95% CI 1.09,1.54). 5Increased estimated risk of blood loss > 500ml (10 trials,OR 1.76, 95% CI 1.34,3.32). 6Reduced reporting of severe pain during second stage of labour (1 trial,OR 0.59, 95% CI 0.41,0.83). 7Fewer abnormal fetal heart rate patterns (1 trial,OR 0.31, 95% CI 0.11,0.91). Reviewers' conclusions: The tentative findings of this review suggest several possible benefits for upright posture, with the possibility of increased risk of blood loss > 500 mL. Women should be encouraged to give birth in the position they find most comfortable. Until such time the benefits and risks of various delivery positions are estimated with greater certainty when methodologically stringent trials data are available, then women should be allowed to make informed choices about the birth positions in which they might wish to assume for delivery of their babies. Citation: Gupta JK, Nikodem VC. Women's position during second stage of labour (Cochrane Review). In: The Cochrane Library, Issue 4, 2000. Oxford: Update Software. [source] Continuity of Caregivers for Care During Pregnancy and ChildbirthBIRTH, Issue 3 2000E.D. Hodnett A substantive amendment to this systematic review was last made on 17 May 1999. Cochrane reviews are regularly checked and updated if necessary. ABSTRACT Background: Social support may include advice or information, tangible assistance, and emotional support. Objectives: The objective of this review was to assess the effects of continuous support during labour (provided by health care workers or lay people) on mothers and babies. Search strategy: I searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. Date of last search: April 1999. Selection criteria: Randomised trials comparing continuous support during labour with usual care. Data collection and analysis: Trial quality was assessed. Study authors were contacted for additional information. Main results: Fourteen trials, involving more than 5000 women, are included in the Review. The continuous presence of a support person reduced the likelihood of medication for pain relief, operative vaginal delivery, Caesarean delivery, and a 5-minute Apgar score less than 7. Continuous support was also associated with a slight reduction in the length of labour. Six trials evaluated the effects of support on mothers' views of their childbirth experiences; while the trials used different measures (overall satisfaction, failure to cope well during labour, finding labour to be worse than expected, and level of personal control during childbirth), in each trial the results favoured the group who had received continuous support. Reviewers' conclusions: Continuous support during labour from caregivers (nurses, midwives, or lay people) appears to have a number of benefits for mothers and their babies and there do not appear to be any harmful effects. Citation: Hodnett ED. Caregiver support for women during childbirth (Cochrane Review). In: The Cochrane Library, Issue 1, 2000. Oxford: Update Software. [source] Should children be screened to undergo early treatment for otitis media with effusion?CHILD: CARE, HEALTH AND DEVELOPMENT, Issue 6 2003A systematic review of randomized trials Abstract Background Otitis media with effusion (OME) is the most common cause of acquired hearing loss in childhood and has been associated with delayed language development and behavioural problems. Some have argued that children should be screened and treated early if found to have clinically important OME. The aim of this review was to assess evidence from randomized controlled trials about the effectiveness of screening and treating children with clinically important OME in the first 4 years of their life. The primary outcome was language development. Methods We searched the Cochrane Controlled Trials Register, MEDLINE and EMBASE and reference lists of all included studies in February 2003. We also contacted the first authors of the studies included in this review. Search terms included otitis media; otitis media with effusion; glue ear; OME; screen; children; treatment; language; and behaviour. Data extraction and methodological quality assessment were performed by at least two of us for each study independently, using methods described in the Cochrane Collaboration Handbook. Results From the three included randomized controlled trials evaluating interventions among children with OME identified through screening, we found no evidence of clinically important benefit in language development. Conclusions The identified randomized trials do not show an important benefit on language development from screening the general population of asymptomatic children in the first 4 years of life to undergo early treatment for OME. Screening asymptomatic children in the first 4 years of life for OME is not recommended. [source] Crystalloid or colloid for partial exchange transfusion in neonatal polycythemia: A systematic review and meta-analysisACTA PAEDIATRICA, Issue 11 2005EUGENE M. DEMPSEY Abstract Aims: To determine whether crystalloid solutions are as effective as colloid solutions when a partial exchange transfusion is performed in newborns with polycythemia. Methods: We searched MEDLINE, EMBASE, and the Cochrane Controlled Trials Register of the Cochrane Library (1966,2004). Keywords used were: polycythemia, partial exchange transfusion, hyperviscosity, and limited to newborn. Randomized studies in newborns with polycythemia were selected for evaluation. Outcomes examined were: long-term neurodevelopment; short-term physiological effects; improvement in clinical symptoms; reduction in haematocrit at 4,6 h; haematocrit at 24 h; and frequency of serious complications. Results: Four randomized controlled clinical trials, including 200 patients in total, with evaluable data, which satisfied our criteria, were found. There were no data on long-term outcomes. There is no reported important difference in short-term physiologic effects. Use of crystalloid was as effective as colloid in both correction of haematological values and reduction of clinical symptoms following partial exchange transfusion. Conclusion: Crystalloid solutions are as effective as colloid solutions for partial exchange transfusion. When crystalloid solutions are used for this purpose, there is no risk of transmission of blood-borne diseases, there is no risk of anaphylaxis, they are rapidly and easily available, and are less expensive. The use of crystalloid should become the standard for partial exchange transfusion. [source] | ||||||||||