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Results for “Randomised controlled trials as topic”

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PubMed2006

Personally addressed hand-signed letters increase questionnaire response: a meta-analysis of randomised controlled trials.

BACKGROUND: Postal questionnaires are commonly used to collect data for health studies, but non-response reduces study sample sizes and can introduce bias. Finding ways to increase the proportion of questionnaires returned would improve research quality. We sought to quantify the effect on response when researchers address participants personally by name on letters that accompany questionnaires. METHODS: All randomised controlled trials in a published systematic review that evaluated the effect on response of including participants' names on letters that accompany questionnaires were included. Odds ratios for response were pooled in a random effects meta-analysis and evidence for changes in effects over time was assessed using random effects meta-regression. RESULTS: Fourteen randomised controlled trials were included covering a wide range of topics. Most topics were unrelated to health or social care. The odds of response when including participants' names on letters were increased by one-fifth (pooled OR 1.18, 95% CI 1.03 to 1.34; p = 0.015). When participants' names and hand-written signatures were used in combination, the effect was a more substantial increase in response (OR 1.45, 95% CI 1.27 to 1.66; p < 0.001), corresponding to an absolute increase in the proportion of questionnaires returned of between 4% and 10%, depending on the baseline response rate. There was no evidence that the magnitude of these effects had declined over time. CONCLUSION: This meta-analysis of the best available evidence indicates that researchers using postal questionnaires can increase response by addressing participants by name on cover letters. The effect appears to be enhanced by including hand-written signatures.

Communication↗
PubMed2005

Hypothermia improves outcome from traumatic brain injury.

Hypothermia for patients with severe traumatic brain injury (TBI) remains controversial despite a strong biological rationale and reasonable evidence from the literature. The "negative" Clifton study seems to have reduced enthusiasm for hypothermia, however the aim of this review is to analyse the evidence from all randomised controlled trials (RCT) and meta-analyses on this topic to determine whether there is adequate support for the view that hypothermia does improve outcome from TBI. The biological rationale for hypothermia is supported by animal and human mechanistic studies of TBI and human clinical studies of brain injury caused by out-of-hospital cardiac arrest. Several small single-centre RCT's have demonstrated that hypothermia leads to both improved survival and improved favourable neurological outcome in TBI. The Clifton study, which was larger and multi-centre, found hypothermia had no major benefits in TBI, although this study can be criticised for several issues of trial methodology (trial design and application of the intervention) and group comparison. Several meta-analyses have given slightly discordant results, but the two most recent meta-analyses agree that hypothermia improves favourable neurological outcome and probably survival. Subsequent to these meta-analyses, a RCT was published which has confirmed that hypothermia is beneficial in a large group of TBI patients. When the published evidence is considered in total, even if hypothermia can't be justified in all TBI patients, if it is applied optimally in the most appropriate patients, hypothermia certainly improves outcome from TBI. If hypothermia is correctly applied (early, long and cool enough) in the optimal group of TBI patients (young with elevated ICP), there seems to be no doubt that hypothermia is effective in improving both survival and favourable neurological outcome from TBI.

Journal Article↗
PubMed1991

Randomisation.

Explore the source record for details and available documents.

Bias↗
PubMed2002

Local treatments for cutaneous warts: systematic review.

OBJECTIVE: To assess the evidence for the efficacy of local treatments for cutaneous warts. METHODS: Systematic review of randomised controlled trials. MAIN OUTCOMES MEASURES: Total clearance of warts and adverse effects such as irritation, pain, and blistering. STUDY SELECTION: Randomised controlled trials of any local treatment for uncomplicated cutaneous warts. All published and unpublished material was considered, with no restriction on date or language. RESULTS: 50 included trials provided generally weak evidence because of poor methods and reporting. The best evidence was for topical treatments containing salicylic acid. Data pooled from six placebo controlled trials showed a cure rate of 75% (144 of 191) in cases compared with 48% (89 of 185) in controls (odds ratio 3.91, 95% confidence interval 2.40 to 6.36). Some evidence for the efficacy of contact immunotherapy was provided by two small trials comparing dinitrochlorobenzene with placebo. Evidence for the efficacy of cryotherapy was limited. No consistent evidence was found for the efficacy of intralesional bleomycin, and only limited evidence was found for the efficacy of topical fluorouracil, intralesional interferons, photodynamic therapy, and pulsed dye laser. CONCLUSIONS: Reviewed trials of local treatments for cutaneous warts were highly variable in methods and quality, and there was a paucity of evidence from randomised, placebo controlled trials on which to base the rational use of the treatments. There is good evidence that topical treatments containing salicylic acid have a therapeutic effect and some evidence for the efficacy of dinitrochlorobenzene. Less evidence was found for the efficacy of all the other treatments reviewed, including cryotherapy.

Anti-Bacterial Agents↗
PubMed2001

Topical phenylephrine increases anal canal resting pressure in patients with faecal incontinence.

INTRODUCTION: The internal anal sphincter receives a stimulatory alpha(1) adrenergic innervation. Use of an adrenergic agonist may therefore have a role in treating patients with faecal incontinence. METHODS: Ten patients (seven females, median age 66 years) with passive faecal incontinence related to weak internal anal sphincter were studied. All patients had intact anal sphincters as assessed by endoanal ultrasound. Phenylephrine gel was applied in a double blind manner in concentrations of 0%, 10%, 20%, 30%, and 40% (Slaco Pharma (UK) Ltd, Watford, UK) on separate days. Maximum resting anal pressure (MRP), anodermal blood flow, blood pressure, and pulse rate were measured before, and one and two hours after application. RESULTS: All concentrations of phenylephrine gel increased median MRP (43, 48, 54, 65, and 70 cm H(2)O, for placebo, 10% (p=0.122), 20% (p=0.170), 30% (p=0.002), and 40% (p=0.004), respectively at one hour; comparisons with placebo). This was sustained at two hours. There was a clear dose-response relationship at one hour. Higher concentrations raised median MRP to within the normal range (> 60 cm H(2)O). At two hours, all concentrations greater than 20% increased the pressure to a similar degree, suggesting that the exact concentration may be important for the initial effect but given a certain threshold is less important after a period of time. Toxicity was rare. Two patients experienced transient perianal burning which settled within a few minutes. There was no significant effect on anodermal blood flow, blood pressure, or pulse rate. CONCLUSION: This study has demonstrated the feasibility of using topical phenylephrine to raise resting anal tone in patients with faecal incontinence. Randomised controlled trials are required to assess the efficacy of this agent.

Administration, Topical↗
PubMed2006

Silver based wound dressings and topical agents for treating diabetic foot ulcers.

BACKGROUND: Foot ulceration affects 15-20% of people with diabetes. It is a major precursor to amputation in this patient group, and early and appropriate treatment provides the greatest opportunity for healing. The use of silver for its antimicrobial properties has re-emerged, and modern wound dressings that release a sustained amount of free silver ions, are now widely used in wound management. OBJECTIVES: To evaluate the effects of silver-containing dressings and topical agents on infection rates and healing of diabetes related foot ulcers. SEARCH STRATEGY: Searches were made of the Cochrane Wounds Group Specialised Register (August 2005), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 3 2005) MEDLINE (1966 to October week 2 2004), EMBASE (1980 to October week 2 2004) and CINAHL (1982 to October week 2 2004). The Journal of Wound Care (Volume 12/13 Issues 1-10) was hand-searched. Manufacturers, researchers and local and international wound groups were contacted in order to identify unpublished trials. Web sites for wound groups and World Wide Wounds (www.worldwidewounds.com) were searched. SELECTION CRITERIA: Randomised controlled trials and non-randomised controlled clinical trials were considered for inclusion. Studies were included if they involved participants with Type 1 or Type 2 diabetes and related foot ulcers, met the requirements for randomisation, allocation and concealment where appropriate, and compared the intervention with a placebo or a sham dressing, an alternative non silver based dressing or no dressing, and reported outcomes that represent healing rate or infection. DATA COLLECTION AND ANALYSIS: Two authors independently evaluated the papers identified by the search strategy against the inclusion criteria but identified no trials eligible for inclusion in the review. It was not possible to perform planned subgroup and sensitivity analysis in the absence of data. In future, if eligible trials become available, a random effects model will be applied for meta-analysis in the presence of statistical heterogeneity (estimated using the I(2) statistic). Dichotomous outcomes will be reported as risk ratios with 95% confidence intervals (CI), and continuous outcomes as weighted mean differences (WMD) with 95% CI. Statistical significance will be set at P value < 0.05 for all outcomes and the magnitude of the effect will be estimated by calculating the number needed to treat (NNT) with 95% CI. MAIN RESULTS: No studies were identified that met with the inclusion criteria AUTHORS' CONCLUSIONS: Despite the widespread use of dressings and topical agents containing silver for the treatment of diabetic foot ulcers, no randomised trials or controlled clinical trials exist that evaluate their clinical effectiveness. Trials are needed to determine clinical and cost-effectiveness and long term outcomes including adverse events.

Administration, Topical↗
PubMed2000

Pain relief with intracameral mepivacaine during phacoemulsification.

AIM: To assess the efficacy and safety of an intraoperative intracameral injection of mepivacaine, administered when patients experienced pain during the course of cataract surgery under topical anaesthesia. METHODS: This is a prospective placebo controlled double masked randomised clinical trial. 50 eyes were included; 25 receiving the active compound and 25 receiving placebo. Mepivacaine (2%, 0.4 ml) or placebo was administered intraoperatively under the iris of the patients who experienced pain during the course of phacoemulsification in spite of previous topical anaesthesia. Efficacy was evaluated by the patients themselves using a five point subjective pain rating scale, the Keele verbal pain chart. Safety was measured by assessing intraocular inflammation (clinical evaluation and laser flare meter), intraocular pressure, and endothelial cell count. RESULTS: The pain rating score significantly diminished after intracameral injection in the mepivacaine group (mean 3.0 (95% CI 2.6-3.4) v 0.8 (0.3-1.3), p<10(-4))) while remaining unchanged in the placebo group (2.9 (2.6-3.2) v 2.9 (2.5-3. 3)), the mean reduction in pain score being significantly different between the two groups (p<10(-4)). There was no indication of increased postoperative ocular inflammation, intraocular pressure change, or endothelial cell loss. CONCLUSIONS: These results suggest that it may not be necessary to systematically add intracameral anaesthesia with topical anaesthesia for cataract surgery. An intraoperative intracameral injection, performed only in patients who happen to suffer during surgery, is safe and effective.

Aged↗
PubMed2004

Nasal decongestants for the common cold.

BACKGROUND: The common cold is a major and recurrent cause of morbidity, affecting children and adults two or more times each year. Nasal congestion is its commonest symptom and many therapies are marketed for its relief. There is no meta-analysis of controlled clinical trials on the effects of nasal decongestants in the common cold. OBJECTIVES: To assess the efficacy of nasal decongestants at reducing the symptom of nasal congestion in adults and children with the common cold and to identify possible adverse effects associated with their use. SEARCH STRATEGY: In updating this review in 2004, the following databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2004) which contains the Cochrane Acute Respiratory Infections Group's specialised register; MEDLINE (January 1996 to February week 1 2004); EMBASE (1996 to February week 7 2004); and Current Contents (February 2004). We handsearched review citations from other references and contacted known principal investigators and pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials with placebo of single-active oral and topical nasal decongestants in adults and children suffering from common cold. DATA COLLECTION AND ANALYSIS: Data were independently extracted by two reviewers (DT and GJL). All outcomes variables were continuous. Subjective outcomes were normalised to a common scale and a weighted mean difference (WMD) was calculated. We calculated a standardised mean difference (SMD) for the objective outcomes. MAIN RESULTS: Five studies involving 286 adults were included, none in children. There was a significant 13% decrease in subjective symptoms after decongestants were compared with placebo. This was supported by a significant decrease in nasal airways resistance. Repeated doses of nasal decongestant were not significantly better than placebo at relieving symptoms of nasal congestion. REVIEWERS' CONCLUSIONS: A single dose of nasal decongestant in the common cold is moderately effective for the short term relief of congestion in adults, while there is no evidence available to show benefit after repeated use over several days. There is insufficient data on the use of these medications in children and therefore they are not recommended for use in young children with the common cold.

Adult↗
PubMedDate not supplied

Chloramphenicol treatment for acute infective conjunctivitis in children in primary care: a randomised double-blind placebo-controlled trial.

BACKGROUND: One in eight schoolchildren have an episode of acute infective conjunctivitis every year. Standard clinical practice is to prescribe a topical antibiotic, although the evidence to support this practice is scarce. We undertook a randomised double-blind trial to compare the effectiveness of chloramphenicol eye drops with placebo in children with infective conjunctivitis in primary care. METHODS: Our study included 326 children aged 6 months to 12 years with a clinical diagnosis of conjunctivitis who were recruited from 12 general medical practices in the UK. We assigned 163 children to receive chloramphenicol eye drops and 163 to receive placebo eye drops. Eye swabs were taken for bacterial and viral analysis. The primary outcome was clinical cure at day 7, which was assessed from diaries completed by parents. All children were followed up for 6 weeks to identify relapse. Survival statistics were used for comparison, and analysis was by intention to treat. FINDINGS: Nine children were lost to follow-up (one in chloramphenicol group; eight in placebo group). Clinical cure by day 7 occurred in 128 (83%) of 155 children with placebo compared with 140 (86%) of 162 with chloramphenicol (risk difference 3.8%, 95% CI -4.1% to 11.8%). Seven (4%) children with chloramphenicol and five (3%) with placebo had further conjunctivitis episodes within 6 weeks (1.2%, -2.9% to 5.3%). Adverse events were rare and evenly distributed between each group. INTERPRETATION: Most children presenting with acute infective conjunctivitis in primary care will get better by themselves and do not need treatment with an antibiotic.

Acute Disease↗
PubMed1997

The effectiveness of topical diclofenac in relieving discomfort following traumatic corneal abrasions.

Diclofenac is a non-steroidal anti-inflammatory drug available in an ophthalmic preparation. We present a prospective randomised double-masked placebo-controlled trial involving 40 patients that assessed the effectiveness of topical diclofenac in relieving pain from traumatic corneal abrasions. Statistical analysis of visual analogue and categorical pain scores revealed a significant reduction in pain experienced by subjects in the diclofenac group (p < 0.02).

Administration, Topical↗
PubMed2006

[The German Network for Evidence-based Medicine -- DNEbM].

The German Network for Evidence-based Medicine (DNEbM) was founded in October 2000. A major impetus for the development of evidence-based medicine (EBM) in Germany came in the mid-1990s from the German Cochrane Initiative, which referred to the principles and activities of the international Cochrane Collaboration. The Network's primary mission is to establish a competence and reference centre for all aspects of evidence-based medicine. Central to this mission is to encourage projects that are concerned with scientific and methodological problems, aspects of professional development and the question of how to translate EBM into clinical practice. With currently more than 600 individual members the DNEbM is the most important society concerned with EBM in the German-speaking region in Europe. Until now, the DNEbM has initiated the development of curricula for EBM and health technology assessment (HTA) for undergraduate and continuing medical education. In addition, position papers regarding hot topics such as prostate cancer screening with PSA or registration of randomised controlled trials were published. The Network's HTA section comprises experts from universities, institutes, health care administration and industry. Currently, the HTA section is developing an Internet-based course for users and doers of HTA reports in Germany.

Biomedical Technology↗