A systematic review of randomised controlled trials on the effectiveness of exercise programs on lumbo pelvic pain among postnatal women

Background: A substantial number of women tend to be affected by Lumbo Pelvic Pain (LPP) following child birth. Physical exercise is indicated as a beneficial method to relieve LPP, but individual studies appear to suggest mixed findings about its effectiveness. This systematic review aimed to synthesise evidence from randomised controlled trials on the effectiveness of exercise on LPP among postnatal women to inform policy, practice and future research. Methods: A systematic review was conducted of all randomised controlled trials published between January 1990 and July 2014, identified through a comprehensive search of following databases: PubMed, PEDro, Embase, Cinahl, Medline, SPORTDiscus, Cochrane Pregnancy and Childbirth Group’s Trials Register, and electronic libraries of authors’institutions. Randomised controlled trials were eligible for inclusion if the intervention comprised of postnatal exercise for women with LPP onset during pregnancy or within 3 months after delivery and the outcome measures included changes in LPP. Selected articles were assessed using the PEDro Scale for methodological quality and findings were synthesised narratively as meta-analysis was found to be inappropriate due to heterogeneity among included studies. Results: Four randomised controlled trials were included, involving 251 postnatal women. Three trials were rated as of ‘good’ methodological quality. All trials, except one, were at low risk of bias. The trials included physical exercise programs with varying components, differing modes of delivery, follow up times and outcome measures. Intervention in one trial, involving physical therapy with specific stabilising exercises, proved to be effective in reducing LPP intensity. An improvement in gluteal pain on the right side was reported in another trial and a significant difference in pain frequency in another. Conclusion: Our review indicates that only few randomised controlled trials have evaluated the effectiveness of exercise on LPP among postnatal women. There is also a great amount of variability across existing trials in the components of exercise programs, modes of delivery, follow up times and outcome measures. While there is some evidence to indicate the effectiveness of exercise for relieving LPP, further good quality trials are needed to ascertain the most effective elements of postnatal exercise programs suited for LPP treatment

Thinking territory historically.

BACKGROUND: While the randomised controlled trial (RCT) is generally regarded as the design of choice for assessing the effects of health care, within the social sciences there is considerable debate about the relative suitability of RCTs and non-randomised studies (NRSs) for evaluating public policy interventions. // OBJECTIVES: To determine whether RCTs lead to the same effect size and variance as NRSs of similar policy interventions; and whether these findings can be explained by other factors associated with the interventions or their evaluation. // METHODS: Analyses of methodological studies, empirical reviews, and individual health and social services studies investigated the relationship between randomisation and effect size of policy interventions by: 1) Comparing controlled trials that are identical in all respects other than the use of randomisation by 'breaking' the randomisation in a trial to create non-randomised trials (re-sampling studies). 2) Comparing randomised and non-randomised arms of controlled trials mounted simultaneously in the field (replication studies). 3) Comparing similar controlled trials drawn from systematic reviews that include both randomised and non-randomised studies (structured narrative reviews and sensitivity analyses within meta-analyses). 4) Investigating associations between randomisation and effect size using a pool of more diverse RCTs and NRSs within broadly similar areas (meta-epidemiology). // RESULTS: Prior methodological reviews and meta-analyses of existing reviews comparing effects from RCTs and nRCTs suggested that effect sizes from RCTs and nRCTs may indeed differ in some circumstances and that these differences may well be associated with factors confounded with design. Re-sampling studies offer no evidence that the absence of randomisation directly influences the effect size of policy interventions in a systematic way. No consistent explanations were found for randomisation being associated with changes in effect sizes of policy interventions in field trials

Clinical trial metadata:Defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme

Background:  By 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot ‘metadata’ on clinical trials funded by the HTA programme.   Objectives: The aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility.   Data sources: Published monographs and internal HTA documents.   Review methods: A database was developed, ‘populated’ using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped.    Results: One hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term ‘randomised trial’ in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data.   Limitations: The study was limited by being confined to 125 randomised trials by one funder.   Conclusions: Metadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here

Overdiagnosis and overtreatment of breast cancer: Overdiagnosis in randomised controlled trials of breast cancer screening

Data from randomised controlled trials of mammographic screening can be used to determine the extent of any overdiagnosis, as soon as either a time equivalent to the lead-time has elapsed after the final screen, or the control arm has been offered screening. This paper reviews those randomised trials for which breast cancer incidence data are available. In recent trials in which the control group has not been offered screening, an excess incidence of breast cancer remains after many years of follow-up. In those trials in which the control arm has been offered screening, although there is a possible shift from invasive to in situ disease, there is no evidence of overdiagnosis as a result of incident screens

Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review

Good quality clinical trials are essential to inform the best cystic fibrosis (CF) management and care, by determining and comparing the effectiveness of new and existing therapies and drug delivery systems. The formal inclusion of quality of life (QoL) as an outcome measure in CF clinical trials is becoming more common. Both an appropriate QoL measure and sound methodology are required in order to draw valid inferences about treatments and QoL. A review was undertaken of randomised controlled trials in cystic fibrosis where QoL was measured. EMBASE, MEDLINE and ISI Web of Science were searched to locate all full papers in the English language reporting randomised controlled trials in cystic fibrosis, published between January 1991 and December 2004. All Cochrane reviews published before December 2004 were hand searched. Papers were included if the authors had reported that they had measured QoL or well being in the trial. 16 trials were identified. The interventions investigated were: antibiotics (4); home versus hospital administration of antibiotics (1); steroids (1); mucolytic therapies (6); exercise (3) and pancreatic enzymes (1). Not one trial evaluated in this review provided conclusive results concerning QoL. This review highlights many of the pitfalls of QoL measurement in CF clinical trials and provides constructive information concerning the design and reporting of trials measuring QoL

Topical analgesia for acute otitis media

BACKGROUND: Acute otitis media (AOM) is a spontaneously remitting disease for which pain is the most distressing symptom. Antibiotics are now known to have less benefit than previously assumed.OBJECTIVES: To assess the effectiveness of topical analgesia for AOM.SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006), MEDLINE (1966 to May Week 3 2006), EMBASE (1990 to December 2005) and LILACS (1982 to September 2005) without language restriction, and the reference lists of articles. We also contacted manufacturers and authors.SELECTION CRITERIA: Double-blind randomised or quasi-randomised controlled trials comparing an otic preparation with an analgesic effect (excluding antibiotics) versus placebo or an otic preparation with an analgesic effect (excluding antibiotics) versus any other otic preparation with an analgesic effect, in adults or children presenting at primary care settings with AOM without perforation.DATA COLLECTION AND ANALYSIS: Potential studies were screened independently and trial quality was assessed by three authors, and differences were resolved by discussion. Data was then independently extracted from the trials selected by two authors. We contacted the authors of three trials to acquire additional information not available in published articles.MAIN RESULTS: Our searches yielded 356 records; four trials met our criteria. One trial with 54 participants compared treatment with anaesthetic ear drops versus an olive oil placebo immediately at diagnosis. All patients were also given paracetamol. There was a statistically significant pain reduction of 25% in those receiving anaesthetic drops 30 minutes after instillation. Three trials (with one common co-author) compared anaesthetic ear drops with naturopathic herbal ear drops in 274 patients. One of these trials also used antibiotics in both groups. There were statistically significant differences at instillation of drops, or 15 or 30 minutes after the instillation (or both) on one to three days after diagnosis, always favouring the naturopathic group in each trial.AUTHORS' CONCLUSIONS: The evidence from these four randomised controlled trials, only one of which addresses the most relevant question of primary effectiveness, is insufficient to know whether ear drops are effective or not.</p

Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals

Objective To examine the prevalence of a risk of bias associated with the design and conduct of cluster randomised controlled trials among a sample of recently published studies. Design Retrospective review of cluster randomised trials published in the BMJ, Lancet, and New England Journal of Medicine from January 1997 to October 2002. Main outcome measures Prevalence of secure randomisation of clusters, identification of participants before randomisation (to avoid foreknowledge of allocation), differential recruitment between treatment arms, differential application of inclusion and exclusion criteria, and differential attrition. Results Of the 36 trials identified, 24 were published in the BMJ, I I in the Lancet, and a single trial in the New England journal of Medicine. At the cluster level, 15 (42%) trials provided evidence for secure allocation and 25 (69%) used stratified allocation. Few trials showed evidence of imbalance at the cluster level. However, some evidence of susceptibility to risk of bias at the individual level existed in 14 (39%) studies. Conclusions Some recently published cluster randomised trials may not have taken adequate precautions to guard against threats to the internal validity of their design

A systematic review and meta-analysis of systemic intraoperative anticoagulation during arteriovenous access formation for dialysis

Purpose: Surgical arteriovenous fistula (AVF) or graft (AVG) is preferred to a central venous catheter for dialysis access. Surgical access may suffer thrombosis early after placement and systemic anticoagulation during surgical access formation may increase patency rates but would be expected to increase bleeding-related complications. A systematic review and meta-analysis of randomised controlled trials was conducted to examine the impact of systemic anticoagulation on access surgery perioperative bleeding and patency rates. Methods: We included randomised controlled trials testing systemic anticoagulation during access formation versus a control group without systemic anticoagulation reporting bleeding complications and access patency. Medline, Embase, CENTRAL and CINAHL were searched up to March 2015. Risk of bias was assessed using the Cochrane risk of bias tool and the Jadad score. Meta-analysis was performed using Cochrane Revman ® software. Results: Searches identified 445 reports of which four randomised studies involving 411 participants were included. Three studies pertained to AVF only and one included both AVF and AVG. Systemic anticoagulation led to increased bleeding events in all access [four trials; risk ratio (RR) 7.18; confidence interval (CI), 2.41 to 21.38; p < 0.001]. Patency was not improved for all access (four trials; RR, 0.64; CI, 0.37 to 1.09; p = 0.10) but was improved when AVF analysed alone (three trials; RR, 0.57; CI, 0.33 to 0.97; p = 0.04). Conclusions: The use of intraoperative systemic anticoagulation during access formation is associated with a highly significant increased risk of bleeding-related complications. A significant improvement in AVF patency was seen, though not when AVF and AVG were analysed together

Decompressive surgery for treating nerve damage in leprosy. A Cochrane review.

OBJECTIVE: Decompressive surgery is used for treating nerve damage in leprosy. We assessed the effectiveness of decompressive surgery for patients with nerve damage due to leprosy. METHODS: A broad search strategy was performed to find eligible studies, selecting randomised controlled trials (RCTs) comparing decompressive surgery alone or plus corticosteroids with corticosteroids alone, placebo or no treatment. Two authors independently assessed quality and extracted data. Where it was not possible to perform a meta-analysis, the data for each trial was summarised. RESULTS: We included two randomised controlled trials involving 88 people. The trials examined the added benefit of surgery over prednisolone for treatment of nerve damage of less than 6 months duration. After 2 years follow-up there was no significant difference in nerve function improvement between people treated with surgery plus prednisolone or with prednisolone alone. Adverse effects of decompression surgery were not adequately described. CONCLUSIONS: Evidence from randomised controlled trials does not show a significant added benefit of surgery over steroid treatment alone. Well-designed randomised controlled trials are needed to establish the effectiveness of the combination of surgery and medical treatment compared to medical treatment alone

Increasing participation of cancer patients in randomised controlled trials: a systematic review

Background: There are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs) of cancer treatments. Methods: A systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted. Results: Eight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work. Conclusion: There is not a strong evidence-base for interventions that increase cancer patient participation in randomised trials. Further research is required to evaluate the effectiveness of strategies to increase participation in cancer treatment trials