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Results for “Randomised controlled trials as topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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PubMed1999

Systematic review of day hospital care for elderly people. The Day Hospital Group.

OBJECTIVE: To examine the effectiveness of day hospital attendance in prolonging independent living for elderly people. DESIGN: Systematic review of 12 controlled clinical trials (available by January 1997) comparing day hospital care with comprehensive care (five trials), domiciliary care (four trials), or no comprehensive care (three trials). SUBJECTS: 2867 elderly people. MAIN OUTCOME MEASURES: Death, institutionalisation, disability, global "poor outcome," and use of resources. RESULTS: Overall, there was no significant difference between day hospitals and alternative services for death, disability, or use of resources. However, compared with subjects receiving no comprehensive care, patients attending day hospitals had a lower odds of death or "poor" outcome (0.72, 95% confidence interval 0.53 to 0.99; P<0.05) and functional deterioration (0.61, 0.38 to 0.97; P<0.05). The day hospital group showed trends towards reductions in hospital bed use and placement in institutional care. Eight trials reported treatment costs, six of which reported that day hospital attendance was more expensive than other care, although only two analyses took into account cost of long term care. CONCLUSIONS: Day hospital care seems to be an effective service for elderly people who need rehabilitation but may have no clear advantage over other comprehensive care. Methodological problems limit these conclusions, and further randomised trials are justifiable.

Aged↗
PubMed2005

Randomisation.

Explore the source record for details and available documents.

Bias↗
PubMed2004

Hypnosis for schizophrenia.

BACKGROUND: Many people with schizophrenia continue to experience symptoms despite the use of conventional treatments. Alternative therapies such as hypnosis, in conjunction with conventional treatments, may prove beneficial to them. OBJECTIVES: To investigate the use of hypnosis for people with schizophrenia or schizophrenia-like illnesses compared to standard care and other interventions. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's Register (January 2003), contacted the Cochrane Complementary Medicine Field for additional searching, hand searched references of included or excluded studies and made personal contact with authors of relevant trials. SELECTION CRITERIA: All randomised or double blind controlled trials that compared hypnosis with other treatments or standard care for people with schizophrenia. DATA COLLECTION AND ANALYSIS: Studies were reliably selected, quality assessed and data extracted. Data were excluded where more than 50% of participants in any group were lost to follow up. For binary outcomes we calculated a fixed effects risk ratio (RR) and its 95% confidence interval (CI). MAIN RESULTS: We included three studies (total n=149). When hypnosis was compared with standard treatment no one left between 1-8 weeks (n=70, 2 RCTs, Risk Difference 0.00 CI -0.09 to 0.09). Mental state scores were unaffected (n=60, 1 RCT, MD BPRS by 1 week -3.6 CI -12.05 to 4.8) as were measures of movement disorders and neurocognitive function. Compared with relaxation, hypnosis was also acceptable (n=106, 3 RCTs, RR leaving the study early 2.00 CI 0.2 to 2.15) and had no discernable effect on mental state (n=60, 1 RCT, MD BPRS by 1 week -3.4 CI -11.4 to 4.6), movement disorders or neurocognitive function. Hypnosis was as acceptable as music (Sibelius) by 4 weeks (n=36, RR leaving the study early 5.0, CI 0.3 to 97.4). REVIEWERS' CONCLUSIONS: The studies in this field are few, small, poorly reported and outdated. Hypnosis could be helpful for people with schizophrenia but to ascertain this requires better designed, conducted and reported randomised studies.

Humans↗
PubMed1997

Short chain fatty acid rectal irrigation for left-sided ulcerative colitis: a randomised, placebo controlled trial.

BACKGROUND: Short chain fatty acid (SCFA) deficiency is associated with colitis in animals and humans, and the mucosal metabolism of these compounds is decreased in ulcerative colitis. AIMS: To assess the efficacy of topical SCFA treatment in ulcerative colitis. PATIENTS AND METHODS: 103 patients with distal ulcerative colitis were entered into a six week, double-blind, placebo controlled trial of rectal SCFA twice daily; patients who were unchanged on placebo were offered SCFA in an open-label extension trial. RESULTS: Of the 91 patients completing the trial, more patients in the SCFA treated than in the placebo treated group improved (33% v 20%, p = 0.14, NS). Those on SCFA also had larger, but statistically non-significant, reductions in every component of their clinical and histological activity scores. In patients with a relatively short current episode of colitis (< 6 months, n = 42), more responded to SCFA than to placebo (48% v 18%, p = 0.03). These patients also had larger, but statistically non-significant, decreases in their clinical activity index (p = 0.08 v placebo). Every patient who improved used at least five of six of the prescribed rectal SCFA irrigations, whereas only 37% who did not improve were as compliant. In the open-label extension trial, 65% improved on SCFA; these patients also had significant reductions (p < 0.02) in their clinical and histological activity scores. CONCLUSIONS: Although SCFA enemas were not of therapeutic value in this controlled trial, the results suggest efficacy in subsets of patients with distal ulcerative colitis including those with short active episodes. Prolonged contact with rectal mucosa seems to be necessary for therapeutic benefit.

Acute Disease↗
PubMed2000

['Informed consent' and prerandomization].

The usual procedure in randomised controlled trials is to obtain informed consent first, after which participants can be randomised. The reversal of the order, first randomisation and then informed consent, is called pre-randomisation (Zelen design). In the Netherlands, there is discussion as to whether pre-randomisation should be allowed in medical research. Full informed consent regarding the design of the investigation may lead to unwanted loss of distinction between the experimental and control groups, thus reducing the internal validity of the investigation. A possible solution could be to include, in the informed consent procedure, the statement that certain information has been withheld because revealing it now would make the investigation useless, but that it will be revealed to all participants afterwards and that the study design was approved by the medical ethics committee. In this way, the advantage of the enhanced internal validity of the pre-randomisation design is retained while simultaneously keeping intact the sequence of first informed consent and then randomisation.

Humans↗
PubMed1988

Topical silver sulphadiazine--a new drug for ocular keratomycosis.

The efficacy of silver sulphadiazine in human keratomycosis has not been evaluated so far. Encouraged by the success of an earlier experimental trial, a prospective, controlled, randomised double masked clinical study was designed to evaluate the efficacy of 1% silver sulphadiazine ophthalmic ointment in 20 eyes of mycotic keratitis. Miconazole 1% was used for comparative evaluation in another 20 eyes. Silver sulphadiazine had a higher success rate (80% vs 55%) than miconazole. It had broad antifungal activity and was found to be effective in fusarium keratitis. Absence of side effects, economy, and its efficacy in deeper and extensive lesions were additional advantages. It is concluded from this study that silver sulphadiazine is a safe and effective broad spectrum antifungal agent which can be used for the treatment of human keratomycosis.

Administration, Topical↗
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↗
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↗