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Results for “Randomised controlled trial”

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PubMed2002

A single infusion of intravenous ketamine improves pain relief in patients with critical limb ischaemia: results of a double blind randomised controlled trial.

We report the first double blind randomised controlled trial of regular opioids and an infusion of low dose (0.6 mg/kg) intravenous ketamine compared with opioids and placebo in patients with allodynia, hyperalgesia and hyperpathia secondary to critical limb ischaemia. Thirty-five patients completed the study, 18 received regular opioids plus ketamine, while 17 received regular opioids plus placebo. Using the Brief Pain Inventory, the % pain relief that the patients in the ketamine group attributed to their medication improved significantly from 50% immediately pre-infusion to 65% 24 h post-infusion and 69% 5 days post infusion. Over the same period, the pain relief achieved by the placebo group rose from 58% pre-infusion to 56% 24 h post infusion and then 50% relief 5 days later. This was statistically significant (P<0.05) using both the t-test and the Wilcoxon Rank Sum test. The ketamine group also showed a statistically significant difference 24 h post infusion of the effect of pain on their general activity (P=0.03) and on their enjoyment of life (P=0.004). This study shows that combining a single infusion of low dose ketamine with regular opioid analgesia can result in a significant improvement in pain relief for this patient group.

Aged↗

PubMed2006

A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial.

We carried out a blinded prospective randomised controlled trial comparing 2-octylcyanoacrylate (OCA), subcuticular suture (monocryl) and skin staples for skin closure following total hip and total knee arthroplasty. We included 102 hip replacements and 85 of the knee.OCA was associated with less wound discharge in the first 24 hours for both the hip and the knee. However, with total knee replacement there was a trend for a more prolonged wound discharge with OCA. With total hip replacement there was no significant difference between the groups for either early or late complications. Closure of the wound with skin staples was significantly faster than with OCA or suture. There was no significant difference in the length of stay in hospital, Hollander wound evaluation score (cosmesis) or patient satisfaction between the groups at six weeks for either hips or knees. We consider that skin staples are the skin closure of choice for both hip and knee replacements.

Adult↗

PubMed1998

Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial.

OBJECTIVES: To explore trial participants' understandings of randomisation. DESIGN: In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews were recorded on audio tape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes, using a grounded theory approach. SETTING: The CLasP study comprises three linked multicentre, pragmatic randomised controlled trials evaluating the effectiveness and cost effectiveness of laser therapy, standard surgery, and conservative management for men with lower urinary tract symptoms or urinary retention, or both, related to benign prostatic disease. SUBJECTS: 20 participants in the CLasP study were interviewed. Sampling was purposeful: men were included from each of the treatment arms, the two major centres, and at different points in the trial. INTERVENTIONS AND OUTCOME MEASURES: Interviews used a checklist of topics to encourage participants to describe their experiences. Narratives concerning randomisation were compared to identify common themes, retaining the context of the discussion to allow detailed interpretation. RESULTS: Most participants recalled and described aspects of randomisation, such as the involvement of chance, comparison, and concealed allocation. Many found the concept of randomisation difficult, however, and developed alternative lay explanations to make sense of their experiences. Inaccurate patient information and lay interpretations of common trial terms caused confusion. CONCLUSIONS: The provision of clear and accurate patient information is important, but this alone will not ensure consistent interpretation of concepts such as randomisation. Patients may need to discuss the purposes of randomisation in order to understand them fully enough to give truly informed consent.

Attitude to Health↗

PubMed2002

Safety education of pedestrians for injury prevention: a systematic review of randomised controlled trials.

OBJECTIVES: To quantify the effectiveness of safety education of pedestrians. DESIGN: Systematic review of randomised controlled trials of safety education programmes for pedestrians of all ages. MAIN OUTCOME MEASURES: Effect of safety education on pedestrians' injuries, behaviour, attitude, and knowledge and on pedestrian-motor vehicle collisions. Quality of trials: methods of randomisation; and numbers lost to follow up. RESULTS: We identified 15 randomised controlled trials of safety education programmes for pedestrians. Fourteen trials targeted children, and one targeted institutionalised adults. None assessed the effect of safety education on the occurrence of pedestrian injury, but six trials assessed its effect on behaviour. The effect of pedestrian education on behaviour varied considerably across studies and outcomes. CONCLUSIONS: Pedestrian safety education can change observed road crossing behaviour, but whether this reduces the risk of pedestrian injury in road traffic crashes is unknown. There is a lack of good evidence of effectiveness of safety education for adult pedestrians, specially elderly people. None of the trials was conducted in low or middle income countries.

Accidents, Traffic↗

PubMed2003

Mammographic screening: evidence from randomised controlled trials.

BACKGROUND: All randomised breast cancer screening trials have shown a reduction in breast cancer mortality in the 'invited for mammography' screening arm compared with the 'control arm' for women aged 50 years and older at randomisation (overall 25%). However, individually published point estimates differ and concern has been raised about methodological quality and outcome measures. Materials and Methods Review of the evidence on breast cancer mortality reduction and discussion of the causes of difference in point estimates in the five Swedish and Canadian trials. A summary of the prerequisites for methodological quality and its available evidence from the trials is given. Data to support breast cancer mortality as a correct outcome measure are presented. RESULTS: There is no reason not to use breast cancer mortality as an outcome measure for trials intended to reduce breast cancer mortality, both from a clinical and a methodological point of view. Everything possible was performed in these trials in order to determine this outcome measure as accurately as possible. The fact that a few of the trials showed a relatively large breast cancer mortality reduction and others far lower reduction rates is irrelevant, if one does not consider the background situation in the region before the trial started, the design of the trial or quality of screening. CONCLUSIONS: There seems no reason to change or halt the current nation-wide population-based screening programmes. Nor is there any justifiable reason for negative reports towards women or professionals.

Adult↗

PubMed2006

Are antibiotics effective for acute purulent rhinitis? Systematic review and meta-analysis of placebo controlled randomised trials.

OBJECTIVE: To systematically review the evidence for the effectiveness of antibiotics in acute purulent rhinitis (many guidelines advise against their use on the basis of one study that showed no effect). DATA SOURCES: Medline, Embase, Cochrane Register of Controlled Trials, and reference lists of retrieved articles. REVIEW METHODS: Meta-analysis of data from double blind randomised placebo controlled trials comparing antibiotics with placebo for acute purulent rhinitis (duration less than 10 days). RESULTS: Seven studies were retrieved; four contributed data on benefits of antibiotics, and four contributed data on harms of antibiotics. The pooled relative risk of benefit for persistent purulent rhinitis at five to eight days with antibiotics was 1.18 (95% confidence interval 1.05 to 1.33). The numbers needed to treat ranged from 7 to 15 when the pooled relative risk was applied to the range of control event rates. The relative risk for adverse effects with antibiotics was 1.46 (1.10 to 1.94). The numbers needed to harm for adverse effects ranged from 12 to 78. No serious harms were reported in the placebo arms. CONCLUSIONS: Antibiotics are probably effective for acute purulent rhinitis. They can cause harm, usually in the form of gastrointestinal effects. Most patients will get better without antibiotics, supporting the current "no antibiotic as first line" advice.

Anti-Bacterial Agents↗

PubMed1993

Infertility treatment: from cookery to science. The epidemiology of randomised controlled trials.

OBJECTIVES: To review the epidemiology of published randomised controlled trials in infertility treatment over the last 25 years, with special emphasis on the number and quality of trials. DESIGN: Computer literature review by MEDLINE backed up by a manual search of 41 journals. Each trial was classified according to the methodology described and quality criteria. The results were recorded in a computer database. Odds ratios (OR) and confidence intervals (CI) were calculated where the data were sufficient. SUBJECTS: Couples suffering from primary or secondary infertility. The trials studied 33,761 patients overall. SETTING: Institute of Epidemiology and Health Services Research, Leeds. RESULTS: Five hundred and one randomised trials in male and female infertility treatment were identified between 1966 and 1990. Pregnancy was an outcome in 291 (58%) and these were the subject of detailed analysis. Two hundred and twenty-four (77%) and 67 (23%) 'pregnancy trials' were concerned, respectively, with female and male infertility. Four per cent of the trials were preceded by a sample size calculation, and the average sample size was 96 patients (range 5-933); 700 patients per group would be required to demonstrate plausible success rates for most treatments. The method of randomisation was unstated or pseudo-randomised in 206 (71%) of trials where pregnancy was an outcome. Only 29 (5.8%) of studies were multicentre. The method of confirmation of pregnancy was omitted for 70% of papers. Cross-over design was used in 103 (21%) of cases. Meta-analysis is possible for selected topics such as the use of anti-oestrogens in idiopathic oligospermia and unexplained female infertility. Eight cases of double reporting were identified. CONCLUSIONS: Trials using randomised methodology were relatively few in comparison with other branches of medicine, although their use is important in the evaluation of treatment for infertility as treatment-independent pregnancy is common. It was encouraging to note that an exponential increase in the use of this methodology occurred during the last three years, especially in association with assisted conception techniques, and meta-analysis has become possible for selected topics. However, many trials suffer from an unrealistically small sample size, inappropriate use of cross-over design or pseudo-randomisation. The trend towards properly controlled studies should be encouraged but these studies should be of improved quality and organised on a multicentre or even international basis.

Female↗

PubMedDate not supplied

Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial.

BACKGROUND: The potential for cyclo-oxygenase 2 (COX2)-selective inhibitors to increase the risk for myocardial infarction is controversial. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) aimed to assess gastrointestinal and cardiovascular safety of the COX2 inhibitor lumiracoxib compared with two non-steroidal anti-inflammatory drugs, naproxen and ibuprofen. METHODS: 18325 patients age 50 years or older with osteoarthritis were randomised to lumiracoxib 400 mg once daily (n=9156), naproxen 500 mg twice daily (4754), or ibuprofen 800 mg three times daily (4415) in two substudies of identical design. Randomisation was stratified for low-dose aspirin use and age. The primary cardiovascular endpoint was the Antiplatelet Trialists' Collaboration endpoint of non-fatal and silent myocardial infarction, stroke, or cardiovascular death. Analysis was by intention to treat. FINDINGS: 81 (0.44%) patients did not start treatment and 7120 (39%) did not complete the study. At 1-year follow-up, incidence of the primary endpoint was low, both with lumiracoxib (59 events [0.65%]) and the non-steroidal anti-inflammatory drugs (50 events [0.55%]; hazard ratio 1.14 [95% CI 0.78-1.66], p=0.5074). Incidence of myocardial infarction (clinical and silent) in the overall population in the individual substudies was 0.38% with lumiracoxib (18 events) versus 0.21% with naproxen (ten) and 0.11% with lumiracoxib (five) versus 0.16% with ibuprofen (seven). In the naproxen substudy, rates of myocardial infarction (clinical and silent) did not differ significantly compared with lumiracoxib in the population not taking low-dose aspirin (hazard ratio 2.37 [95% CI 0.74-7.55], p=0.1454), overall (1.77 [0.82-3.84], p=0.1471), and in patients taking aspirin (1.36 [0.47-3.93], p=0.5658). In the ibuprofen substudy, these rates did not differ between lumiracoxib and ibuprofen in the population not taking low-dose aspirin (0.75 [0.20-2.79], p=0.6669), overall (0.66 [0.21-2.09], p=0.4833), and in patients taking aspirin (0.47 [0.04-5.14], p=0.5328). INTERPRETATION: The primary endpoint, including incidence of myocardial infarction, did not differ between lumiracoxib and either ibuprofen or naproxen, irrespective of aspirin use. This finding suggests that lumiracoxib is an appropriate treatment for patients with osteoarthritis, who are often at high cardiovascular risk and taking low-dose aspirin.

Aged↗

PubMed2002

Randomised controlled trials in nursing and midwifery: an interview with Maralyn Foureur. Interview by Pamela J. Wood.

Randomised controlled trials are considered to be one of the best research designs for determining effective care in the clinical setting. Relatively few randomised controlled trials, however, have been carried out in nursing or midwifery practice, so few examples of the practical realities of this research methodology are readily accessible. This is the sixth article in a series based on interviews with nursing and midwifery researchers, designed to offer the beginning researcher a first-hand account of the experience of using particular methodologies. This article focuses on the randomised controlled trial as experienced by Maralyn Foureur (RGON, RM, BA, Grad Dip Clin Epidem, PhD) who used this methodology to demonstrate the effectiveness of a continuity of care model in midwifery practice.

Continuity of Patient Care↗

PubMed1993

Developing a register of randomised controlled trials in primary care.

OBJECTIVE: To determine the number, nature, site of publication, and feasibility of identifying randomised controlled trials relevant to primary care. DESIGN: Review of literature using three strategies: approaching journal editors, Medline search, and manual search of individual journals. SETTING: Journals containing publications of studies based in primary care. MAIN OUTCOME MEASURES: The number, site of publication, and subject of trials identified. RESULTS: No journal had a system which enabled identification of all the randomised controlled trials it published. 266 trials relevant to primary care were identified from 110 different journals during 1987-91 by Medline. Of these, only 62 trials were published in primary care journals. Hand searching of seven major primary care research journals showed that between 13% and 38% of the trials had been missed by the Medline search. Of the trials identified, 47 (18%) were concerned with mental disease (including neuroses, tobacco misuse and alcohol misuse) and 43 (16%) were concerned with hypertension. CONCLUSION: Given the diversity of publication sources and topics, this supports the need for a centrally based register of randomised controlled trials that may be relevant to primary care overviews in the future.

Humans↗

PubMed2004

Implementing the UK Medical Research Council (MRC) RT01 trial (ISRCTN 47772397): methods and practicalities of a randomised controlled trial of conformal radiotherapy in men with localised prostate cancer.

BACKGROUND AND PURPOSE: Radiotherapy is the most frequently used treatment for men with localised prostate cancer. Conformal radiotherapy (CFRT) is a relatively new development. MRC RT01 was set-up to explore optimum CFRT dose. PATIENTS AND METHODS: RT01 was an international multi-centre randomised controlled trial for men with T1b-T3a, N0, M0 prostate cancer that evolved from a single-centre pilot trial of similar design. All men received at least 3 months of pre-radiotherapy hormone treatment, before randomisation to standard (64 Gy) or high dose (74 Gy) radical CFRT. Accrual was completed in December 2001 with 843 men randomised from 25 centres in less than 4 years. RT01 has been a catalyst for implementing CFRT across UK. In addition to the Trial Management Group, independent Data Monitoring and Ethics Committee and independent Trial Steering Committee, a Quality of Life and Health Economics (QL/HE) group, a radiotherapy Quality Assurance (QA) Group and a Radiography Trial Implementation Group were set up. The QL/HE group ensured implementation, compliance, analysis and interpretation of the QL and HE data in the trial. The inauguration of QA and Radiography groups facilitated inter-centre collaboration. The QA Group ensured procedures were in place before and during trial participation, and monitored quality and consistency with systems including a physics questionnaire, a clinical examples exercise, a standard operating procedure document, designing and building a phantom, and convening a complications modelling subgroup. The Radiography group agreed and implemented technique improvements. RESULTS: More centres participated than initially predicted, enabling recruitment better than scheduled. The trial expedited the implementation of CFRT in many UK radiotherapy centres. Additionally, the QA and Radiography groups helped ensure smooth initiation and established consistency in planning, dosimetry and delivery of prostate CFRT services at participating UK centres. Considerable data has been collected; a series of papers will be produced, although mature clinical trial results are not anticipated until 2006-2008.

Humans↗

PubMedDate not supplied

Randomised controlled trials in Irish general practice.

There have been a limited number of randomised controlled trials carried out in Irish general practice. This paper presents an overview of the particular issues involved, based on a recently completed randomised controlled trial of diabetes shared care. Study design, ethical considerations, practice and patient related factors including recruitment and barriers to participation and the role of parallel economic and qualitative analyses are considered with a view to informing future study design.

Delivery of Health Care, Integrated↗

PubMed2001

Treatment of irritable bowel syndrome: a review of randomised controlled trials.

Irritable bowel syndrome (IBS) is a common chronic disorder that is associated with significant disability and health care costs. The purpose of this paper is to review and assess published randomised controlled trials examining the clinical effectiveness of interventions for IBS for 1987-1998. A literature search was conducted to identify randomised controlled trials of IBS treatments: 45 studies were identified that described randomised controlled trials and of these, six fulfilled all three criteria used to assess the quality of randomised controlled trials, as described by Jadad and colleagues.(1) These criteria are: adequate description of randomisation, double blinding, and description of withdrawals and dropouts. It is concluded that there are few studies which offer convincing evidence of effectiveness in treating the IBS symptom complex. This review strongly suggests that future work should include well designed trials that: describe the randomisation method; use internationally approved diagnostic criteria; and are double blinded and placebo controlled. Clear well defined outcome measures are necessary. Inclusion of quality of life measures allows comparison between trials in different therapeutic areas. Conducting such studies will help to overcome some of the difficulties identified in this review.

Colonic Diseases, Functional↗

PubMed1994

Participation in breast cancer screening: randomised controlled trials of doctors' letters and of telephone reminders.

The study used a randomised controlled trial to find out whether supporting letters from general practitioners accompanying the invitations from a screening centre affected participation in a population-based breast cancer screening program for women aged 50 to 64. A further randomised controlled trial compared the effect of postal reminders with telephone reminders for women who did not respond to an initial invitation to participate in the program. There were 482 women in the first trial and 641 in the second. Excluding women who were ineligible or could not be contacted, participation in screening was 71 per cent in the group which received letters from their general practitioners compared with 62 per cent in the group which did not receive letters (P = 0.059). In the group that received letters, 56 per cent were screened without a reminder compared with 43 per cent of the group that did not receive letters (P = 0.01). Fewer women who received letters from their general practitioners declined the invitation to be screened (P = 0.048). In the second trial, there was no difference in participation between the group receiving telephone reminders and the group receiving postal reminders. As in breast cancer screening programs in other countries, general practitioner endorsement of invitations increased participation in breast cancer screening. Postal reminders were as effective as telephone reminders in encouraging women who did not respond to an initial invitation to participate in screening.

Breast Neoplasms↗

PubMed1986

Vegetarian diet in mild hypertension: a randomised controlled trial.

In a randomised crossover trial 58 subjects aged 30-64 with mild untreated hypertension were allocated either to a control group eating a typical omnivorous diet or to one of two groups eating an ovolactovegetarian diet for one of two six week periods. A fall in systolic blood pressure of the order of 5 mm Hg occurred during the vegetarian diet periods, with a corresponding rise on resuming a meat diet. The main nutrient changes with the vegetarian diet included an increase in the ratio of polyunsaturated to saturated fats and intake of fibre, calcium, and magnesium and a decrease in the intake of protein and vitamin B12. There were no consistent changes in urinary sodium or potassium excretion or body weight. In untreated subjects with mild hypertension, changing to a vegetarian diet may bring about a worthwhile fall in systolic blood pressure.

Adult↗

PubMed2006

Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process.

OBJECTIVE: To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good test of the effectiveness of continuous consent. METHODS: Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the validity of parental consent based on the consent components of competence, information, understanding and voluntariness. RESULTS: No marked problems with consent validity at the point of signature were observed in 19 of 27 (70%) couples. Problems were found mainly to lie with the competence and understanding of the parents: mothers, particularly, had problems with competence in the early stages of consent. Problems in understanding were primarily to do with side effects. Problems in both competence and understanding were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further discussion took place. Randomisation was generally understood but unpopular. Information was not always given by clinicians in stages during the short period available before parents gave consent. Most clinicians, however, were able to give follow-up information. DISCUSSION: Consent validity was found to compare favourably with similar trials examined in the Euricon study. CONCLUSION: Adopting the elements of the continuous consent process and clinician training in RCTs should be considered by researchers, particularly when they have concerns about the quality of consent they are likely to obtain by using a conventional process.

Adolescent↗

PubMed2006

Effectiveness of physiotherapy in Parkinson's disease: the feasibility of a randomised controlled trial.

To study the feasibility of a large randomised controlled trial (RCT) evaluating the effectiveness of physiotherapy in Parkinson's disease (PD), 173 patients were asked to participate in a study with random allocation to best practice physiotherapy, or to no physiotherapy. The primary outcome measures were the Parkinson's disease questionnaire-39, the Parkinson activity scale, and a patient preference outcome scale (PPOS). Only 14% of the patients could be included in the study. The PPOS showed the largest effect size (0.74) with a significant group effect (p<0.05). Specific alterations to the study design to ensure successful RCTs in this field are recommended.

Aged↗

PubMed1997

Language bias in randomised controlled trials published in English and German.

BACKGROUND: Some randomised controlled trials (RCTs) done in German-speaking Europe are published in international English-language journals and others in national German-language journals. We assessed whether authors are more likely to report trials with statistically significant results in English than in German. METHODS: We studied pairs of RCT reports, matched for first author and time of publication, with one report published in German and the other in English. Pairs were identified from reports round in a manual search of five leading German-language journals and from reports published by the same authors in English found on Medline. Quality of methods and reporting were assessed with two different scales by two investigators who were unaware of authors' identities, affiliations, and other characteristics of trial reports. Main study endpoints were selected by two investigators who were unaware of trial results. Our main outcome was the number of pairs of studies in which the levels of significance (shown by p values) were discordant. FINDINGS: 62 eligible pairs of reports were identified but 19 (31%) were excluded because they were duplicate publications. A further three pairs (5%) were excluded because no p values were given. The remaining 40 pairs were analysed. Design characteristics and quality features were similar for reports in both languages. Only 35% of German-language articles, compared with 62% of English-language articles, reported significant (p < 0.05) differences in the main endpoint between study and control groups (p = 0.002 by McNemar's test). Logistic regression showed that the only characteristic that predicted publication in an English-language journal was a significant result. The odds ratio for publication of trials with significant results in English was 3.75 (95% CI 1.25-11.3). INTERPRETATION: Authors were more likely to publish RCTs in an English-language journal if the results were statistically significant. English language bias may, therefore, be introduced in reviews and meta-analyses if they include only trials reported in English. The effort of the Cochrane Collaboration to identify as many controlled trials as possible, through the manual search of many medical journals published in different languages will help to reduce such bias.

Bias↗