Home About us Contact
|
Home About us Contact | ||
|
|
||
Trial Quality (trial + quality)
Selected AbstractsWhat interventions should we add to weight reducing diets in adults with obesity?JOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 4 2004A systematic review of randomized controlled trials of adding drug therapy, behaviour therapy or combinations of these interventions, exercise Abstract Background, Evidence is needed for the effectiveness of interventions given with reducing diets for obese adults: drug therapy, exercise, or behaviour therapy. Methods, We systematically reviewed randomized controlled trials in any language. We searched 13 databases and handsearched journals. Trials lasted 1 year or more. One investigator extracted data and a second checked data extraction. Trial quality was assessed. Results, Adding orlistat to diet was associated with weight change for up to 24 months (,3.26 kg, 95% CI, ,4.15 to ,2.37 kg), and statistically significant beneficial changes were found for total and LDL cholesterol, blood pressure and glycaemic control. Adding sibutramine to diet was associated with a 12 month weight change of ,4.18 kg (95% CI, ,5.14 to ,3.21 kg), and statistically significant beneficial effects on high density lipoprotein cholesterol (HDL) and triglycerides (TGs), but an increase in diastolic blood pressure. Adding exercise to diet, or to diet and behaviour therapy, was associated with improved weight loss for up to 36 months and improvements in HDL, TGs and blood pressure. Adding behaviour therapy to diet, or to diet and sibutramine together, was associated with improved weight loss for up to 18 months. Adding drugs, exercise or behaviour therapy to dietary advice was each associated with similar weight change. Conclusions, Adding orlistat, sibutramine, exercise, or behaviour modification to dietary advice can improve long-term weight loss. [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] 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 04 March 1998. Cochrane reviews are regularly checked and updated if necessary. ABSTRACT Background: Care is often provided by multiple caregivers, many of whom work only in the antenatal clinic, labour ward, or postnatal unit. However, continuity of care is provided by the same caregiver or a small group from pregnancy through the postnatal period. Objectives: The objective of this review was to assess continuity of care during pregnancy and childbirth and the puerperium with usual care by multiple caregivers. Search strategy: The Cochrane Pregnancy and Childbirth Group trials register was searched. Selection criteria: Controlled trials comparing continuity of care with usual care during pregnancy, childbirth and the postnatal period. Data collection and analysis: Trial quality was assessed. Study authors were contacted for additional information. Main results: Two studies involving 1815 women were included. Both trials compared continuity of care by midwives with non-continuity of care by a combination of physicians and midwives. The trials were of good quality. Compared to usual care, women who had continuity of care from a team of midwives were less likely to be admitted to hospital antenatally (odds ratio 0.79, 95% confidence interval 0.64,0.97) and more likely to attend antenatal education programs (odds ratio 0.58, 95% confidence interval 0.41,0.81). They were also less likely to have drugs for pain relief during labour (odds ratio 0.53, 95% confidence interval 0.44,0.64), and their newborns were less likely to require resuscitation (odds ratio 0.66, 95% confidence interval 0.52,0.83). No differences were detected in Apgar scores, low birthweight, and stillbirths or neonatal deaths. While they were less likely to have an episiotomy (odds ratio 0.75, 95% confidence interval 0.60,0.94), women receiving continuity of care were more likely to have either a vaginal or perineal tear (odds ratio 1.28, 95% confidence interval 1.05, 1.56). They were more likely to be pleased with their antenatal, intrapartum, and postnatal care. Reviewers' conclusions: Studies of continuity of care show beneficial effects. It is not clear whether these are due to greater continuity of care, or to midwifery care. Citation: Hodnett ED. Continuity of caregivers for care during pregnancy and childbirth (Cochrane Review). In: The Cochrane Library, Issue 2, 2000. Oxford: Update Software. The preceding reports are abstracts of regularly updated, systematic reviews prepared and maintained by the Cochrane Collaboration. The full texts of the reviews are available in The Cochrane Library (ISSN 1464-780X). Seehttp://www.update-software.com/cochrane.htmor contact Update Software,info@update.co.uk, for information on subscribing to The Cochrane Library in your area. Update Software Ltd, Summertown Pavilion, Middle Way, Oxford OX2 7LG, United Kingdom (Tel.: +44 1865 513902; Fax: +44 1865 516918). [source] SELECTED COCHRANE SYSTEMATIC REVIEWS Absorbable Synthetic Versus Catgut Suture Material for Perineal RepairBIRTH, Issue 2 2000C. Kettle A substantive amendment to this systematic review was last made on 19 May 1999. Cochrane reviews are regularly checked and updated if necessary. ABSTRACT Background and objectives: Approximately 70% of women will experience some degree of perineal trauma following vaginal delivery and will require stitches. This may result in perineal pain and superficial dyspareunia. The objective of this review was to assess the effects of absorbable synthetic suture material as compared with catgut on the amount of short- and long-term pain experienced by mothers following perineal repair. Search strategy: We searched the Cochrane Pregnancy and Childbirth Group trials register. Selection criteria: Randomised trials comparing absorbable synthetic (polyglycolic acid and polyglactin) with plain or chromic catgut suture for perineal repair in mothers after vaginal delivery. Data collection and analysis: Trial quality was assessed independently by two reviewers. Data were extracted by one reviewer and checked by the second reviewer. Main results: Eight trials were included. Compared with catgut, the polyglycolic acid and polyglactin groups were associated with less pain in first three days (odds ratio 0.62, 95% confidence interval 0.54,0.71). There was also less need for analgesia (odds ratio 0,63, 95% confidence interval 0.52,0.77) and less suture dehiscence (odds ratio 0.45, 95% confidence interval 0.29,0.70). There was no significant difference in long-term pain (odds ratio 0.81, 95% confidence interval 0.61,1.08). Removal of suture material was significantly more common in the polyglycolic acid and polyglactin groups (odds ratio 2.01, 95% confidence interval 1.56,2.58). There was no difference in the amount of dyspareunia experienced by women. Reviewers' conclusions: Absorbable synthetic suture material (in the form of polyglycolic acid and polyglactin sutures) for perineal repair following childbirth appears to decrease women's experience of short-term pain. The length of time taken for the synthetic material to be absorbed is of concern. A trial addressing the use of polyglactin has recently been completed and this has been included in this updated review. Citation: Kettle C, Johanson RB. Absorbable synthetic versus catgut suture material for perineal repair (Cochrane Review). In: The Cochrane Library, Issue 4, 1999, Oxford: Update Software. ,,, The preceding report is an abstract of regularly updated, systematic reviews prepared and maintained by the Cochrane Collaboration. The full texts of the reviews are available in The Cochrane Library (ISSN 1464-780X). Seehttp://www.update-software.com/cochrane.htmor contact Update Software,info@update.co.uk, for information on subscribing to The Cochrane Library in your area. Update Software Ltd, Summertown Pavilion, Middle Way, Oxford OX2 7LG, United Kingdom (Tel.: +44 1865 513902; Fax: +44 1865 516918). [source] Safety and Clinical Effectiveness of Midazolam versus Propofol for Procedural Sedation in the Emergency Department: A Systematic ReviewACADEMIC EMERGENCY MEDICINE, Issue 1 2008Corinne Michèle Hohl MD Abstract Objectives:, To synthesize the evidence comparing the adverse event (AE) profile and clinical effectiveness of midazolam and propofol for procedural sedation (PS) in adults in the emergency care setting. Methods:, The authors conducted a systematic review of randomized controlled trials (RCTs) and observational studies reporting the use of either midazolam and/or propofol for adult PS in the emergency department (ED). A systematic search strategy was developed and applied to six bibliographic reference databases. Three emergency medicine journals, the Canadian Adverse Drug Reaction Newsletter, and conference proceedings were hand-searched. Retrieved articles were reviewed and data were abstracted using standardized data collection. Trial quality was assessed using the Jadad score. The outcomes assessed were the proportion of patients with AEs and the pooled mean difference in the proportion of patients with successful PS. Results:, Of 229 articles identified, 28 met the inclusion criteria for the analysis of AEs. Only one major AE to PS was found, resulting in no statistically significant difference in the proportion of major AEs between agents. Four studies were RCTs that met the inclusion criteria for the analysis of clinical effectiveness. Two trials met criteria for good quality. The RCTs enrolled between 32 and 86 patients, and the most common indications for PS were orthopedic reductions and cardioversions. There was a nonsignificant difference in the proportion of patients with successful PS in favor of propofol (effect difference 2.9%, 95% confidence interval (CI) = ,6.5 to 15.2). Conclusions:, The authors found no significant difference in the safety profile and the proportion of successful PS between midazolam and propofol for adults in the ED. [source] The effectiveness of brief alcohol interventions in primary care settings: A systematic reviewDRUG AND ALCOHOL REVIEW, Issue 3 2009EILEEN F. S. KANER Abstract Issues. Numerous studies have reported that brief interventions delivered in primary care are effective in reducing excessive drinking. However, much of this work has been criticised for being clinically unrepresentative. This review aimed to assess the effectiveness of brief interventions in primary care and determine if outcomes differ between efficacy and effectiveness trials. Approach. A pre-specified search strategy was used to search all relevant electronic databases up to 2006. We also hand-searched the reference lists of key articles and reviews. We included randomised controlled trials (RCT) involving patients in primary care who were not seeking alcohol treatment and who received brief intervention. Two authors independently abstracted data and assessed trial quality. Random effects meta-analyses, subgroup and sensitivity analyses and meta-regression were conducted. Key Findings. The primary meta-analysis included 22 RCT and evaluated outcomes in over 5800 patients. At 1 year follow up, patients receiving brief intervention had a significant reduction in alcohol consumption compared with controls [mean difference: ,38 g week,1, 95%CI (confidence interval): ,54 to ,23], although there was substantial heterogeneity between trials (I2 = 57%). Subgroup analysis confirmed the benefit of brief intervention in men but not in women. Extended intervention was associated with a non-significantly increased reduction in alcohol consumption compared with brief intervention. There was no significant difference in effect sizes for efficacy and effectiveness trials. Conclusions. Brief interventions can reduce alcohol consumption in men, with benefit at a year after intervention, but they are unproven in women for whom there is insufficient research data. Longer counselling has little additional effect over brief intervention. The lack of differences in outcomes between efficacy and effectiveness trials suggests that the current literature is relevant to routine primary care. [Kaner EFS, Dickinson HO, Beyer F, Pienaar E, Schlesinger C, Campbell F, Saunders JB, Burnand B, Heather N. The effectiveness of brief alcohol interventions in primary care settings: A systematic review. Drug Alcohol Rev 2009;28:301,323] [source] Psychosocial interventions and quality of life in gynaecological cancer patients: a systematic reviewPSYCHO-ONCOLOGY, Issue 8 2009Jolyn Hersch Abstract Objective: Women with gynaecological cancer are at risk of poor quality of life outcomes. Although various psychosocial interventions have been developed to address these concerns, such interventions have not yet been systematically evaluated in this population. The current review provides an up-to-date and comprehensive summary of the evidence regarding the effectiveness of psychosocial interventions in women with gynaecological cancers. Methods: Relevant studies were identified via Medline, CINAHL, and PsycINFO databases (1980 to June 2008), reference lists of articles and reviews, grey literature databases, and consultations with physicians and other experts in the field. Only controlled trials comparing a psychosocial intervention with a control group in a gynaecological cancer population, with at least one quality of life variable as a main outcome, were included in the review. Two authors independently assessed trial quality and extracted data. Results: Twenty-two studies involving 1926 participants were included. There was substantial variability in study quality and results. Evidence was mixed regarding intervention effects on social and sexual functioning, distress, depression, anxiety, attitude to medical care, self-esteem and body image. Interventions generally did not improve physical or vocational outcomes. Conclusions: There was limited evidence in support of healing touch, whereas information-based interventions seemed largely unable to provide meaningful benefits. Cognitive-behavioural interventions had some positive effects. Counselling appeared to be the most promising intervention strategy for addressing quality of life concerns for women with gynaecological cancers. Copyright © 2008 John Wiley & Sons, Ltd. [source] Secular changes in the quality of published randomized clinical trials in rheumatologyARTHRITIS & RHEUMATISM, Issue 3 2002Catherine L. Hill Objective To assess the quality of published randomized clinical trials (RCTs) in rheumatology and to determine whether there has been improvement in quality between 2 time periods, 1987,1988 and 1997,1998. Methods Using MEDLINE and a hand search of selected rheumatology journals, we identified RCTs of adult rheumatic diseases published in English in 1987,1988 or 1997,1998. We examined trial quality with an expanded version of the Jadad scale, which assesses the adequacy of reported random sequence generation, allocation concealment, blinding, and analysis. All trials were read by 1 reviewer, with prior standardization using a random sample read by 2 reviewers. We also evaluated "high"- versus "low"-impact journals based on citation index. Results Two hundred forty RCTs (1987,1988 119 RCTs, 1997,1998 121 RCTs) were assessed. Results showed improvement in the quality of the trials, but the rates of reported random sequence generation, allocation concealment, power, and intent-to-treat analyses were persistently low. Low rates of reports of random sequence generation, allocation concealment, and intent-to-treat analyses were present even in the high-impact journals. Conclusion There has been improvement in the quality of reporting of RCTs in rheumatology between 1987,1988 and 1997,1998. However, methodologic problems such as lack of allocation concealment, inadequate random sequence generation, lack of reporting of power, and lack of intent-to-treat analyses remain common. Many of these problems are established sources of bias in RCTs and are easily rectifiable. [source] Interventions for treating traumatized permanent front teeth: avulsed (knocked out) and replantedAUSTRALIAN DENTAL JOURNAL, Issue 2 2010P Day Background:, Dental trauma is common. One of the most severe injuries is when a permanent tooth is knocked completely out (avulsed) of the mouth. In most circumstances the tooth should be replanted as quickly as possible. There is uncertainty on how best to prepare teeth for replantation. Objectives:, To compare the effects of a range of interventions for managing traumatized permanent teeth with avulsion injuries. Search strategy:, The Cochrane Oral Health Group's Trials Register (to 28th October 2009); CENTRAL (The Cochrane Library 2009, Issue 4); MEDLINE (1950 to October 2009); EMBASE (1980 to October 2009); http://www.clinicaltrials.gov/;www.controlled-trials.com/ and reference lists of articles were searched. There were no language restrictions. Selection criteria:, Only randomized controlled trials (RCTs), that included a minimum follow-up period of 12 months, for interventions for avulsed and replanted permanent teeth were considered. Data collection and analysis:, Two review authors independently extracted data and assessed trial quality and the risk of bias in studies to be included. Main results:, Three studies, involving a total of 162 patients and 231 teeth were identified. Study one (with a high risk of bias) investigated the effect of extra-oral endodontics. This showed no significant difference in radiographic resorption compared with intra-oral endodontics provided at week 1 for teeth avulsed for longer than 60 minutes dry time. Study two (which had a moderate risk of bias) investigated a 10-minute soaking in thymosin alpha 1 prior to replantation and then its further use as a daily gingival injection for the first 7 days. They reported a strong benefit at 48 months (14% with periodontal healing in the control group versus 77% for the experimental group). Study three (with a high risk of bias) investigated a 20-minute soaking with gentamycin sulphate (4 × 107 U/L) for both groups prior to replantation and then the use of hyperbaric oxygen daily in the experimental group for 80 minutes for the first 10 days. They reported a strong benefit at 12 months (43% periodontal healing versus 88% for the experimental group). There was no formal reporting of adverse events. Authors' conclusions:, The available evidence suggests that extra-oral endodontics is not detrimental for teeth replanted after more than 60 minutes dry time. Studies with moderate/high risk of bias indicate that soaking in thymosin alpha 1 and gentamycin sulphate followed by hyperbaric oxygen may be advantageous. However, they have not previously been reported as interventions for avulsed teeth and need further validation. More evidence with low risk of bias is required and, with the low incidence of avulsed teeth, collaborative multicentre trials are indicated. Plain language summary:, Treatments for managing knocked out and replanted front teeth. Injuring your front teeth during childhood is common. One of the most severe injuries occurs when the tooth is knocked totally out of the mouth (avulsed). Often the best option is to replant the tooth as quickly as possible. This is true only for permanent teeth. Once replanted the tooth can heal in two ways if managed correctly. Ideally the ligament around the root reforms and the tooth can be expected to last as long as any other tooth; this is known as ,periodontal healing'. When there is too much damage to the ligament, healing occurs by bony replacement and the tooth is replaced by bone and lost over a few years. This is called ,bony healing'. Bony healing causes significant problems in the medium term for children and treatments for this are the subject of a different Cochrane review. A missing front upper tooth or teeth, as a result of not replanting an avulsed tooth or as a treatment for bony healing, can have a major effect on dental and facial ,good looks'. This can affect the individual's self-esteem and general social interaction, as well as how others think and see them. This Cochrane review investigated what treatments encourage the tooth to repair by periodontal healing. Three studies were found. The benefits of these treatments require further investigation before specific medicaments can be advised. This is because the studies had weakness in their design which may have influenced the benefits they found. The following general treatment principle can be concluded which reinforces current treatment guidelines: For teeth with little chance of periodontal healing, a root canal treatment can be carried out before the tooth is replanted without further detrimental effects. [source] | ||||||||||