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Results for “Randomised controlled trial”

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At least 127 records · Page 7Linked to original sources

PubMed2006

High-intensity functional exercise program and protein-enriched energy supplement for older persons dependent in activities of daily living: a randomised controlled trial.

The aims of this randomised controlled trial were to determine if a high-intensity functional exercise program improves balance, gait ability, and lower-limb strength in older persons dependent in activities of daily living and if an intake of protein-enriched energy supplement immediately after the exercises increases the effects of the training. One hundred and ninety-one older persons dependent in activities of daily living, living in residential care facilities, and with a Mini-Mental State Examination (MMSE) score of ? 10 participated. They were randomised to a high-intensity functional exercise program or a control activity, which included 29 sessions over 3 months, as well as to protein-enriched energy supplement or placebo. Berg Balance Scale, self-paced and maximum gait speed, and one-repetition maximum in lower-limb strength were followed-up at three and six months and analysed by 2 x 2 factorial ANCOVA, using the intention-to-treat principle. At three months, the exercise group had improved significantly in self-paced gait speed compared with the control group (mean difference 0.04 m/s, p = 0.02). At six months, there were significant improvements favouring the exercise group for Berg Balance Scale (1.9 points, p = 0.05), self-paced gait speed (0.05 m/s, p = 0.009), and lower-limb strength (10.8 kg, p = 0.03). No interaction effects were seen between the exercise and nutrition interventions. In conclusion, a high-intensity functional exercise program has positive long-term effects in balance, gait ability, and lower-limb strength for older persons dependent in activities of daily living. An intake of protein-enriched energy supplement immediately after the exercises does not appear to increase the effects of the training.

Activities of Daily Living↗

PubMed2004

The DiAMOND trial protocol: a randomised controlled trial of two decision aids for mode of delivery among women with a previous caesarean section [ISRCTN84367722].

BACKGROUND: Caesarean section (CS) has become an increasingly common method of delivery worldwide, rising in the UK from 9% of deliveries in 1980 to over 21% 2001. This increase, and the question of whether CS should be available to women on request, has been the subject of considerable debate, and national reports and guidelines have specifically highlighted the importance of patient choice in the decision making process. For women who have already experienced CS, the UK National Institute of Clinical Excellence recommends that the decision should consider maternal preferences and priorities in addition to general discussion of the overall risks and benefits of CS. Decision aids for many different medical treatment and screening decisions have been developed and evaluated, but there is relatively little evidence for the use of decision aids for choice of mode of delivery among women with a previous CS. The aim of the study is to evaluate two interventions to assist decision making about mode of delivery among pregnant women with one previous CS. METHODS/DESIGN: Women with one previous CS are recruited to the trial during their booking visit at approximately 12-20 weeks' gestation in participating maternity units in Bristol, Weston and Dundee. Using central randomisation, women are allocated to one of three arms: information programme and website; decision analysis; usual care. Both interventions are computer-based, and are designed to provide women with detailed information about the potential outcomes for both mother and baby of planned vaginal delivery, planned CS and emergency CS. The decision analysis intervention additionally provides a recommended 'preferred option' based on maximised expected utility. There are two primary outcomes (decisional conflict and actual mode of delivery), and five secondary outcomes (anxiety, knowledge, perceptions of shared decision making; satisfaction with decision making process, proportion of women attempting vaginal delivery). Primary follow up for the questionnaire measures is at 36-37 weeks' gestation, and a total of 660 women will be recruited to the study. The primary intention-to-treat analyses will comprise three pair-wise comparisons between decision analysis, information and usual care groups, for each of the two primary outcomes. A qualitative study will investigate women's experiences of the decision making in more depth, and an economic evaluation from the perspective of the NHS will be conducted. DISCUSSION: Provision of information to women facing this decision appears variable. The DiAMOND study aims to inform best practice in this area by evaluating the effectiveness of two interventions designed to aid decision making.

Journal Article↗

PubMed2004

Metronidazole for the prevention of dry socket after removal of partially impacted mandibular third molar: a randomised controlled trial.

We randomised 119 patients who had been referred for removal of partially impacted mandibular third molars to be given either metronidazole 1600 mg or placebo as a single dose 45 min before operation. Ten of the fifty-nine patients who were given metronidazole and 13 of the 60 given placebo developed dry sockets. Two variables were significantly associated with the development of a dry socket: pericoronitis and oral contraceptives.

Administration, Oral↗

PubMed2004

Telephone or surgery asthma reviews? Preferences of participants in a primary care randomised controlled trial.

263 participants completing a randomised controlled trial comparing telephone vs. face-to-face asthma consultations were asked about preferences for future reviews. Qualitative analysis of data from 209 respondents identified divergent views. Clear opinions were expressed about the respective roles of the two modes of consulting; telephone consultations were considered convenient for reviewing 'well controlled' asthma, whereas face-to-face consultations were perceived as allowing in-depth assessment of problems in those with more symptomatic asthma. Practices may consider offering patients the choice of a telephone or face-to-face review.

Journal Article↗

PubMed2004

Effectiveness of an education programme by a general practice assistant for asthma and COPD patients: results from a randomised controlled trial.

In this study a randomised controlled trial was carried out to investigate the effectiveness of an education programme for patients with asthma or chronic obstructive pulmonary disease (COPD). All asthma and COPD patients using medication and experiencing pulmonary symptoms were randomly assigned to the intervention (n=139) or usual-care group (n=137). The intervention consisted of taylor-made education conducted by a general practice assistant and focussing on a patients' technical skills and coping with the disease. Measurements took place at baseline, and after 1 and 2 years of follow-up. After 1 and 2 years the inhalation technique was significantly better in the intervention group compared to the usual-care group. No significant differences were observed regarding disease symptoms, health related quality of life, compliance, smoking cessation, self-efficacy, and coping. The results only support the implementation of the intervention regarding the technical skills (inhalation technique). However, given the importance of improvement of patients' coping and the need for more efficient care, we recommend further exploration of the possibilities of a more structured and intensive education programme.

Adaptation, Psychological↗

PubMed2003

What is the research question? A case study in the early stages of design of a randomised controlled trial for a complementary therapy.

Randomised controlled trials (RCTs) can be used to evaluate aspects of the effectiveness of complementary therapies. Given the individualised and non-blindable nature of many treatments, the design of such studies is often not trivial. One decision to be made is what specific research question is to be asked, of the many potential questions that could be asked. This paper describes discussions that took place during the design of a trial to evaluate the effectiveness of herbal practitioners for menopausal women, and illustrates the tribulations associated with such a process. Specifically, it discusses implications of the choice of control group. It is critically important that a relevant and answerable research question is posed.

Complementary Therapies↗

PubMed2000

Treatment satisfaction of patients with lower urinary tract symptoms: randomised controlled trials vs. real life practice.

Randomised controlled trials (RCTs) are an important scientific tool to determine the efficacy and tolerability of a given treatment relative to placebo or other treatment forms. However, due to strict inclusion and exclusion criteria the patient populations in RCTs may not be fully representative for those routinely consulting the physician. Moreover, participation in a formal study puts physician and patient in a situation where they may react different than in real life. In contrast real life practice (RLP) studies cannot determine treatment efficacy or tolerability in absolute terms since they typically do not include a control group and are purely observational. On the other hand, they tend to be more representative for real treatment outcomes. Thus, RCTs have high internal but less external validity whereas RLP studies have less internal and greater external validity. Hence, RCTs and RLP studies should not be considered as mutually exclusive but rather as complementing each other. Specific advantages and disadvantages of RCTs and RLP studies will be discussed using published evidence for the treatment of lower urinary tract symptoms suggestive of benign prostatic obstruction with alpha1-adrenoceptor antagonists and other treatments.

Humans↗

PubMed2005

Razors versus clippers. A randomised controlled trial.

The purpose of this randomised controlled trial was to determine if patients showed a preference for preoperative hair removal with razors or clippers and to identify if one method was associated with more trauma or postoperative infections. The trial took place in a day surgery unit with patients who were having a range of surgical procedures including hernias and varicose veins. This study was sponsored by an award from the NATN/3M Clinical Fellowship.

Hair Removal↗

PubMed1998

Surgery and the randomised controlled trial: past, present and future.

Randomised controlled trials (RCTs), with their prospective definition of methods and outcome measures, double-blind assessment of outcomes and unbiased selection of subjects and controls, provide the best possible evidence for deciding the value of a medical or surgical intervention. Few surgical studies are designed as RCTs, and those that are should be of a higher quality. The lack of good surgical RCTs may be a result of surgeons lacking the necessary training, expertise and desire to perform RCTs, inadequate funding from granting agencies, difficulties in securing patient consent or a lack of sufficient patient numbers. If an RCT is not feasible for a particular study, then alternative research designs, such as prospective matched-pair trials, may need to be better developed and used. If RCTs can be performed, other strategies to increase the number and quality of RCTs may be needed: Education of surgeons in clinical research methods Improved funding of surgical RCTs Compulsory evaluation of new techniques and technology before their general adoption is permitted.

Evidence-Based Medicine↗

PubMed2003

Computerised reminders and feedback in medication management: a systematic review of randomised controlled trials.

OBJECTIVE: To systematically review randomised controlled trials (RCTs) of computer-generated medication reminders or feedback directed to healthcare providers or patients. DATA SOURCES: Extensive computerised and manual literature searches identified 76 English-language reports of RCTs reported before 1 January 2002. Searches were conducted between June 1998 and April 2002. STUDY SELECTION: 26 papers making 29 comparisons (two papers reported on multiple interventions) of computer-supported medication management to a control group. DATA EXTRACTION: The quality of the RCTs was systematically assessed and scored independently by two reviewers. Rates of compliance with (potential) reminders for the control and intervention groups were extracted. DATA SYNTHESIS: Heterogeneity of studies prevented a meta-analysis. Where possible, rates were calculated using the intention-to-treat principle. The comparisons were grouped into five areas. Reminders to providers in outpatient settings: six of 12 comparisons demonstrated positive effects (relative rates [RRs: intervention rates/control rates], 1.0 to 42.0). Provider feedback in outpatient settings: five of seven comparisons showed improved clinician behaviour (RRs, 1.0 to 2.5). Combined reminders and feedback in outpatient settings: the single comparison found no improvement. Reminders to providers in inpatient settings: three of five comparisons showed improvements (RRs, 1.0 to 2.1). Patient-directed reminders: two of four comparisons showed improvements in patient compliance. CONCLUSION: Reminders are more effective than feedback in modifying physician behaviour related to medication management. Patient-directed reminders can improve medication adherence.

Drug Therapy↗

PubMed1986

Improvement in bronchial hyper-responsiveness in patients with moderate asthma after treatment with a hypnotic technique: a randomised controlled trial.

A prospective, randomised, single blind, and controlled trial of a hypnotic technique was undertaken in 39 adults with mild to moderate asthma graded for low and high susceptibility to hypnosis. After a six week course of hypnotherapy 12 patients with a high susceptibility score showed a 74.9% improvement (p less than 0.01) in the degree of bronchial hyper-responsiveness to a standardised methacholine challenge test. Daily home recordings of symptoms improved by 41% (p less than 0.01), peak expiratory flow rates improved by 5.5% (p less than 0.01), and use of bronchodilators decreased by 26.2% (p less than 0.05). The improvement in bronchial hyper-reactivity occurred without a change in subjective appreciation of the degree of bronchoconstriction. A control group 17 patients and 10 patients undergoing treatment with low susceptibility to hypnosis had no change in either bronchial hyper-responsiveness or any of the symptoms recorded at home. This study shows the efficacy of a hypnotic technique in adult asthmatics who are moderately to highly susceptible to hypnosis.

Adult↗

PubMed2003

Descriptive survey of non-commercial randomised controlled trials in the United Kingdom, 1980-2002.

OBJECTIVES: To describe the characteristics of randomised controlled trials supported by the main non-commercial sources of funding in the United Kingdom between 1980 and 2002. DESIGN: Descriptive survey. SETTING: Randomised controlled trials funded by the Medical Research Council, NHS research and development programme, Department of Health, Chief Scientist Office in Scotland, and medical research charities. PARTICIPANTS: 1464 randomised controlled trials supported by the main non-commercial sources of funding. RESULTS: Support for randomised controlled trials by the main sources of non-commercial funding in the United Kingdom has fallen in recent years, without any concomitant increase in the sample sizes of these studies. Drug trials in a limited range of health problems have dominated among the studies supported by the Medical Research Council and medical research charities. Until recently, the NHS research and development programme supported randomised controlled trials of various healthcare interventions, in a wide range of health problems, but between 1999 and 2002 many of the subprogrammes that had commissioned trials were discontinued. CONCLUSIONS: The future of non-commercial randomised controlled trials in the United Kingdom has been threatened by the discontinuation or demise of national and regional NHS research and development programmes. Support also seems to be declining from the Medical Research Council and the medical research charities. It is unclear what the future holds for randomised controlled trials that address issues of no interest to industry but are of great importance to patients and practitioners.

Financing, Organized↗

PubMed1998

Randomised controlled trials in single patients.

Results of large randomised controlled trials may not help in deciding treatment for an individual patient. This may be because the patient differs clinically from those in the trials, or because wide variations between individuals in a trial limit the applicability of results to an individual patient. In these circumstances, a randomised controlled trial in the individual patient (an n-of-1 trial) may help. This approach may also help when the prescriber or patient doubts whether the treatment is, or will be, beneficial, when the optimal dosage is uncertain, or to assess whether an unwanted effect is due to a particular treatment. Here we discuss the use of this technique.

Double-Blind Method↗

PubMed2004

Mifepristone and misoprostol versus dilation and evacuation for midtrimester abortion: a pilot randomised controlled trial.

OBJECTIVE: To test the feasibility of mounting a randomised controlled trial comparing mifepristone-misoprostol versus dilation and evacuation (D&E) for midtrimester abortion. DESIGN: Pilot randomised controlled trial. SETTING: University of North Carolina Hospitals, Chapel Hill, North Carolina. POPULATION: Women aged 18 years or older and without prior uterine operations who requested abortion at 14-19 menstrual weeks of gestation from January 2002 to January 2003. METHODS: Participants received either mifepristone 200 mg by mouth followed in two days by vaginal then oral misoprostol (Aberdeen regimen) or D&E after one or two days of laminaria preparation. Care was provided by residents under faculty supervision. MAIN OUTCOME MEASURES: Enrolment rate and acceptability of and adverse events associated with methods. RESULTS: The trial was stopped at one year because of slow enrolment. Of 47 women eligible for the trial, 29 (62%) declined participation, primarily because of a preference for D&E abortion. Among the 18 participants enrolled, nine were randomised to treatment with mifepristone-misoprostol and 9 to D&E. Compared with D&E, mifepristone-misoprostol abortion caused more pain and adverse events, although none was serious. CONCLUSIONS: Our findings concerning acceptability and adverse events should be considered hypothesis-generating; they may prove useful in planning a larger randomised controlled trial. Such a trial will be difficult to mount in the US. Hence, we suggest that it be done in a setting where labour-induction abortion is the norm.

Abortifacient Agents↗

PubMed2000

Percutaneous transluminal coronary angioplasty versus medical treatment for non-acute coronary heart disease: meta-analysis of randomised controlled trials.

OBJECTIVE: To determine whether percutaneous transluminal coronary angioplasty (angioplasty) is superior to medical treatment in non-acute coronary artery disease. DESIGN: Meta-analysis of randomised controlled trials. SETTING: Randomised controlled trials conducted worldwide and published between 1979 and 1998. PARTICIPANTS: 953 patients treated with angioplasty and 951 with medical treatment from six randomised controlled trials, three of which included patients with multivessel disease and pre-existing myocardial infarction. MAIN OUTCOME MEASURES: Angina, fatal and non-fatal myocardial infarction, death, repeated angioplasty, and coronary artery bypass grafting. RESULTS: In patients treated with angioplasty compared with medical treatment the risk ratios were 0. 70 (95% confidence interval 0.50 to 0.98; heterogeneity P<0.001) for angina; 1.42 (0.90 to 2.25) for fatal and non-fatal myocardial infarction, 1.32 (0.65 to 2.70) for death, 1.59 (1.09 to 2.32) for coronary artery bypass graft, and 1.29 (0.71 to 3.36; heterogeneity P<0.001) for repeated angioplasty. Differences in the methodological quality of the trials, in follow up, or in single versus multivessel disease did not explain the variability in study results in any analysis. CONCLUSIONS: Percutaneous transluminal coronary angioplasty may lead to a greater reduction in angina in patients with coronary heart disease than medical treatment but at the cost of more coronary artery bypass grafting. Trials have not included enough patients for informative estimates of the effect of angioplasty on myocardial infarction, death, or subsequent revascularisation, though trends so far do not favour angioplasty.

Angina Pectoris↗

PubMed2002

Patient-centred equipoise and the ethics of randomised controlled trials.

The ethical pre-condition of randomised controlled trials is, at present, the presence of equipoise. This refers to an opinion of the investigator that there is uncertainty as to the merits of the treatments being compared. It is argued that since the decision to enrol is the potential subject's, the investigator's opinion is not ethically relevant. It is proposed instead that equipoise be patient-centred, and that a trial is in equipoise for a patient when enrolling gives them the same chance of a good outcome as not enrolling. It is shown that trial enrolment is normally easily the best strategy for achieving a good outcome, and that trials currently thought to be unethical may be in patient-centred equipoise. This is so for three reasons: (1) patients in trials receive superior care, (2) trial enrolment minimises the risk of being a victim of a therapeutic disaster and (3) health professionals make mistakes, and a 50% chance of receiving the worse treatment until a trial reports is always better than any chance of receiving the worse treatment indefinitely. It is concluded that so long as the standard of professional conduct is the furtherance of patients' objective interests randomised controlled trials are ethical.

Decision Making↗

PubMed2006

EU-USA pathology panel for uniform diagnosis in randomised controlled trials for HRCT screening in lung cancer.

Randomised controlled trials for lung cancer screening using high-resolution computed tomography are now underway. In order to allow effective future comparison of the different trials, as well as strengthening conclusions based upon the analysis of larger data sets, uniformity and consistency of pathology diagnosis are essential. The aim of the present study was to determine the effectiveness of the learning process in this difficult area of diagnostic pathology. Eight pathologists received two CD-ROMs, each with digital images of 30 cases. After diagnosing the first series, selected background reading was provided. Kappa (kappa) scores were calculated for each pathologist and category, and were compared to the consensus score. The readings of the first series showed a moderate agreement kappa score: mean+/-sd for category numbers 8 (all eight categories) and 2 were 0.53+/-0.05 and 0.65+/-0.04, respectively. The kappa 2 score distinguished between categories denoting benign and malignant lesions. The second series resulted in a good agreement kappa score: 0.65+/-0.06 for category number 8 and 0.81+/-0.02 for category number 2. In conclusion, this study demonstrates that screen-detected cases pose particular problems for pathologists and that a trained pathology panel serving randomised controlled trials is likely to lead to more consistent and accurate tissue diagnosis.

Adenocarcinoma↗

PubMed1996

What proportion of primary psychiatric interventions are based on evidence from randomised controlled trials?

OBJECTIVES: To estimate the proportion of psychiatric inpatients receiving primary interventions based on randomised controlled trials or systematic reviews of randomised controlled trials. DESIGN: Retrospective survey. SETTING: Acute adult general psychiatric ward. SUBJECTS: All patients admitted to the ward during a 28 day period. MAIN OUTCOME MEASURES: Primary interventions were classified according to whether or not they were supported by evidence from randomised controlled trials or systematic reviews. RESULTS: The primary interventions received by 26/40 (65%; 95% confidence interval (95% CI) 51% to 79%) of patients admitted during the period were based on randomised trials or systematic reviews. CONCLUSIONS: When patients were used as the denominator, most primary interventions given in acute general psychiatry were based on experimental evidence. The evidence was difficult to locate; there is an urgent need for systematic reviews of randomised controlled trials in this area.

Adult↗