SEARCH · PubMed Health

Results for “Randomised controlled trial”

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.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 739 records · Page 41Linked to original sources

PubMed2006

External validity of randomised controlled trials in asthma: to whom do the results of the trials apply?

BACKGROUND: Asthma is a heterogeneous disease with a wide range of clinical phenotypes, not all of which may be encompassed in the subjects included in randomised controlled trials (RCTs). This makes it difficult for clinicians to know to what extent the evidence derived from RCTs applies to a given patient. AIM: To calculate the proportion of individuals with asthma who would have been eligible for the major asthma RCTs from the data of a random community survey of respiratory health. METHODS: A postal survey was sent to 3500 randomly selected individuals aged 25-75 years. Respondents were invited to complete a detailed respiratory questionnaire and pulmonary function testing. Participants with current asthma were assessed against the eligibility criteria of the 17 major asthma RCTs cited in the Global Initiative for Asthma (GINA) guidelines. FINDINGS: A total of 749 participants completed the full survey, of whom 179 had current asthma. A median 4% of participants with current asthma (range 0-36%) met the eligibility criteria for the included RCTs. A median 6% (range 0-43%) of participants with current asthma on treatment met the eligibility criteria. INTERPRETATION: This study shows that the major asthma RCTs on which the GINA guidelines are based may have limited external validity as they have been performed on highly selected patient populations. Most of the participants with current asthma on treatment in the community would not have been eligible for these RCTs.

Adult↗

PubMed2002

Sexual health clinics for women led by specialist nurses or senior house officers in a central London GUM service: a randomised controlled trial.

OBJECTIVES: To assess the care process and clinical outcomes for two different models of GUM clinic for women: one led by specialist nurses and the other by senior house officers (SHOs). METHOD: An open randomised controlled trial was carried out in a central London genitourinary medicine (GUM) women's clinic. Of 1172 women telephoning for an appointment, 880 were randomised to provide 169 eligible patients in the specialist nurse arm and 178 in the SHO arm. Of the eligible patients a total of 224 attended their appointment. The clinical records of the randomised women were audited for adequacy of care according to local guidelines. 30 key variables were objectively assessed and recorded on a standard audit form. An overall unitary index score (%) was calculated for each patient. The main variables associated with the outcome of specialist nurse and SHO decision making (diagnostic test request, preliminary diagnosis, and treatment provided) were then analysed independently. RESULTS: The median documentation audit scores for specialist nurses (n=103) and SHOs (n=121) were 92% and 85% respectively (p<0.0001). The specialist nurses' documentation was significantly (p<0.05) more complete than the SHOs' for five variables: details of menstrual cycle, physical examination, medication instructions given to patients, health promotion discussion, and provision of condoms. Specialist nurses performed equally to the SHOs with regard to requesting the correct diagnostic tests, providing the correct preliminary diagnosis, and providing the correct treatment. CONCLUSIONS: A model of care using trained GUM nurses working within agreed protocols can provide comprehensive patient care for female patients that is equal to care provided by SHOs. Our results raise important issues regarding advanced GUM nursing education and training, protocol development, and accountability.

Adolescent↗

PubMed1999

Randomised controlled trial of effect of Baby Check on use of health services in first 6 months of life.

OBJECTIVE: To evaluate the effect of Baby Check, an illness scoring system for babies of 6 months or less, on parents' use of health services for their baby. DESIGN: Randomised controlled trial. SETTING: 13 general practices in Glasgow. SUBJECTS: 997 newly delivered mothers, randomised to receive either Baby Check and Play It Safe, an accident prevention leaflet (n=497), or Play It Safe alone (control group, n=500). MAIN OUTCOME MEASURES: Data on consultations and referrals extracted from general practice notes after 6 months. RESULTS: At the time of recruitment, maternal characteristics were similar for both groups (mean maternal age 29 years; deprivation categories 6 and 1 in both groups; 424 (45%) mothers were primiparous). At 6 months, general practice notes were available for 467 (94%) of the Baby Check group and 468 (94%) of the control group. The number of general practitioner consultations did not differ between the groups: median number of consultations was 2 (interquartile range 1 to 4) in the Baby Check group, and 2 (1 to 3) in the control group. Use of out of hours services did not differ significantly between the two groups (86 v 85; P=0.93). CONCLUSION: Distributing Baby Check to an unselected group of mothers does not affect use of health services for infants up to 6 months of age.

Adult↗

PubMed2026

Mechanisms of impact of mental health peer support in high-, middle- and low-income settings: mediation analysis of the UPSIDES randomised controlled trial.

AIMS: While there is growing evidence for the effectiveness of peer support (PS) in improving psychosocial outcomes among individuals with severe mental health conditions, the mechanisms through which these effects occur remain insufficiently understood. This study examines whether social inclusion, hope and empowerment mediate the relationship between PS, personal recovery and health and social functioning. METHODS: Data were collected from 565 adults with severe mental health conditions who participated in the multicentre UPSIDES randomised controlled trial across six sites in Germany, Uganda, Tanzania, India and Israel. Participants in the intervention group received structured PS from trained peer workers over a 6- to 8-month period. Standardised, self-report measures of social inclusion, hope, empowerment and personal recovery, as well as clinician-rated health and social functioning, were administered at baseline, 4 months, end of intervention (8 months) and 12-month follow-up. Cross-lagged panel modelling was used to explore longitudinal associations and mediating pathways. RESULTS: The cross-lagged models showed strong autoregressive effects across all variables, indicating high temporal stability. There were no significant direct effects of PS on recovery or health and social functioning. However, mediation analysis identified significant indirect effects of PS on personal recovery via social inclusion (β = 0.114, 95% confidence interval [CI] [0.049, 0.194], P < 0.05) and hope (β = 0.037, 95% CI [0.001, 0.086], P < 0.05). Similar indirect effects were observed for health and social functioning (via social inclusion: β = -0.035, 95% CI [-0.064, -0.013]; via hope: β = -0.026, 95% CI [-0.052, -0.006]; both P < 0.05). CONCLUSIONS: Findings suggest that PS affects recovery-related outcomes primarily through intermediate mechanisms of enhanced hope and social inclusion. These results support theoretical models positing indirect pathways of change in PS interventions and highlight the value of targeting social and psychological domains when designing and implementing PS in mental health services. Individuals with lower baseline levels of hope and social inclusion may particularly benefit from PS.

Humans↗

PubMed2005

The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411].

BACKGROUND: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. METHODS: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients. General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD. Patients are invited to attend regular four-monthly consultations over two years, during which targets and goals for secondary prevention are set and reviewed. The analysis will be strengthened by economic, policy and qualitative components.

Journal Article↗

PubMed1996

A multicentre randomised controlled trial comparing elective and selective caesarean section for the delivery of the preterm breech infant.

OBJECTIVE: To determine the optimum mode of delivery for women in preterm breech labour at a gestational age of 26 to 32 weeks. DESIGN: A multicentre randomised controlled trial. SETTING: Twenty-six hospitals in England, UK. PARTICIPANTS: Women with a singleton breech fetus in spontaneous preterm labour between 26 and 32 completed weeks of gestation, with no clear indication for a caesarean section or vaginal breech delivery. INTERVENTION: Random allocation to either "intention to delivery vaginally' or "intention to deliver by caesarean section'. MAIN OUTCOME MEASURES: Perinatal mortality, neonatal morbidity, maternal morbidity and gestation at delivery. RESULTS: The trial was closed after 17 months because of low recruitment, by which time substantial numbers of women had been in the eligible gestation period. Thirteen women from six hospitals were recruited. One infant, randomised to and delivered vaginally, was stillborn. Three fetal presentations were cephalic at delivery despite a diagnosis of breech presentation at trial entry. No formal statistical analysis was performed due to the small numbers. CONCLUSIONS: No conclusions about the optimum mode of delivery for women in preterm labour with a fetus presenting by the breech can be drawn from this trial. The low accrual rate was due to clinicians' reluctance to randomise eligible women, reflecting the circumstances and nature of the trial.

Adult↗

PubMed2006

Sub-vastus approach versus the medial parapatellar approach in primary total knee: a randomised controlled trial [ISRCTN44544446].

BACKGROUND: Thirty thousand knee replacements are performed annually in the UK. There is uncertainty as to the best surgical approach to the knee joint for knee arthroplasty. We planned a randomised controlled trial to compare a standard medial parapatellar arthrotomy with sub-vastus arthrotomy for patients undergoing primary total knee arthroplasty in terms of short and long term knee function. METHODS: Patients undergoing primary total knee arthroplasty at the local NHS Trust are to be recruited into the study. Patients are to be randomised into either the sub-vastus or medial parapatellar approach to knee arthroplasty. The primary outcome measures will be the American Knee Society and WOMAC Scores. The secondary outcome measures will be patient based measures of EuroQol and SF-36. All outcomes will be measured pre-operatively, 1, 6, 12 and 52 weeks post-operatively. We will also review pain intensity using a pain and analgesia diary. Ease of surgical exposure and complications will also be analysed. DISCUSSION: Evidence is lacking concerning the best surgical approach to the knee joint for patients undergoing primary total knee replacement. This pragmatic randomised trial tests the hypothesis that the sub-vastus approach is significantly superior to the standard medial parapatellar approach in terms of short and long term knee function.

Journal Article↗

PubMed2005

A randomised controlled trial of nurse-managed trial conclusion following early phase cancer trial participation.

The effect of a nurse-managed intervention, for early phase cancer trial participants at trial conclusion, on psychosocial outcomes was evaluated at two cancer centres in the Midlands, England using a randomised controlled trial. It involved 117 patients who were participating in an early phase cancer clinical trial. It was a nurse-managed trial exit, which included a trial exit interview, trial feedback information leaflet and telephone follow-up compared with standard care at trial conclusion. Psychological distress at 1 week and 4-6 weeks post-trial conclusion, patient's knowledge and understanding and patient's satisfaction were assessed. The results showed there was no significant difference between the two groups regarding scores for anxiety and depression at time one and time two. There is some suggestion that the intervention reduced anxiety from trial conclusion to follow-up (P=0.27). Patients in both groups felt they had contributed to cancer research through trial participation. However, intervention patients were more likely to feel that they knew how the trial was going (P<0.001), knew how other people in the trial were doing (P=0.001), had all the feedback they needed about the trial they took part in (P<0.01) and knew how they would be followed up (P=0.02). Patient satisfaction with the intervention was high (median score=4.5 where 5 is greatest satisfaction). In conclusion, nurse-managed trial conclusion led to positive outcomes for patients who had recently completed a clinical trial.

Antineoplastic Agents↗

PubMed2002

The implementation of guidelines and computerised forms improves the completeness of cancer pathology reporting. The CROPS project: a randomised controlled trial in pathology.

The aim of this study was to determine whether reporting guidelines and computerised form-based reports improve the completeness of histopathological cancer data available for patient management and population cancer registration and to evaluate the acceptability of the intervention. The study was a randomised controlled trial with a split unit design and stratified cluster randomisation. All 16 hospital pathology laboratories in Wales were randomly allocated to report either breast or colorectal resection specimens by computerised form or conventional free text. 1044 reports were analysed in the study arm, 998 in the control arm. Use of pre-defined forms led to a 28.4% (95% confidence interval (CI): 15.7-41.2%) increase in complete reporting of a minimum dataset required for cancer registration and a 24.5% (95% CI: 11.0-38.0%) increase in complete reporting of minimum data required for patient management. Form-based reporting was acceptable to pathologists and preferred by clinicians. In conclusion, guidelines and computerised forms significantly improve the quality of histopathology reporting.

Breast Neoplasms↗

PubMed2005

A randomised controlled trial of 6 and 12 hourly administration of vaginal misoprostol for second trimester pregnancy termination.

OBJECTIVE: To compare the effectiveness of vaginal misoprostol administered 6 or 12 hourly for second trimester pregnancy termination. DESIGN: A randomised controlled trial. SETTING: University teaching hospital. SAMPLE: Two hundred and seventy-nine pregnant women at gestations between 14 and 26 weeks undergoing pregnancy termination. METHODS: Women were randomised to receive 600-microg misoprostol tablets vaginally either every 6 hours or every 12 hours until abortion occurred. MAIN OUTCOME MEASURES: Induction-abortion interval, success rate within 24 and 48 hours and adverse effects. RESULTS: There was no significant difference in the median induction to abortion interval 6 hours (16 hours) and 12 hours (16 hours; P= 0.80). The total dose of misoprostol was higher in the 6-hour group (1800 vs 1200 microg). The cumulative abortion rates within 24 hours were 74% and 67% and within 48 hours 94% and 92%, in the 6- and 12-hour groups, respectively. Fever was more common in the 6-hour group (53%) versus the 12-hour group (31%; P < 0.001). The incidence of nausea, vomiting, diarrhoea, severe bleeding and abdominal pain were similar. CONCLUSIONS: Misoprostol (600 microg) administered at 12-hour intervals was associated with fewer adverse effects and was as effective as a 6-hour interval.

Abortifacient Agents, Nonsteroidal↗

PubMed1994

Randomised controlled trial of health promotion in general practice for patients at high cardiovascular risk.

OBJECTIVE: To assess the value of health education for patients with angina in reducing risk factors for cardiovascular disease and lessening the effect of angina on everyday activities. DESIGN: Randomised controlled trial of personal health education given every four months. SETTING: 18 general practices in the greater Belfast area. SUBJECTS: 688 patients aged less than 75 years and known to have had angina for at least six months; 342 randomised to receive education and 346 to no education. MAIN OUTCOME MEASURES: Restriction of everyday activities, dietary habit, smoking habit, frequency of physical exercise; blood pressure, body mass index, and serum total cholesterol concentration at entry to trial and after two years. RESULTS: 317 in the intervention group and 300 in the control group completed the trial. At the two year review more of the intervention group (140, 44%) reported taking daily physical exercise than the control group (70, 24%). The intervention group also reported eating a healthier diet than the control group and less restriction by angina in any everyday activity. No significant differences were found between the groups in smoking habit, systolic or diastolic blood pressure, cholesterol concentration, or body mass index. CONCLUSION: Despite having no significant effect on objective cardiovascular risk factors, personal health education of patients with angina seems to increase exercise and improve dietary habits and is effective in lessening the restriction of everyday activities.

Activities of Daily Living↗

PubMed1992

A randomised controlled trial of long stay nursing home and geriatric ward care for the elderly. A summary of main findings.

This paper reports outcome data on mental and physical ability levels, mortality and accidents rates, from a randomised controlled trial evaluating health authority funded nursing home and long stay geriatric ward care in one inner London health district. There were no differences between settings in relation to mortality rates, although respondents randomised to the nursing homes deteriorated more rapidly in overall and functional ability levels; they also experienced a higher accident rate than respondents in the wards. This has to be balanced against the previously published observational data from the evaluation which clearly indicated that quality of life in the homes was superior to that in the wards. There was more occupational therapy input into the wards in comparison with the homes, and activities were promoted most in the patient's Club in the hospital setting. Although quality of life was superior in the homes in relation to flexibility and preservation of resident's dignity.

Accidents↗

PubMed2005

Computer-mediated instructional video: a randomised controlled trial comparing a sequential and a segmented instructional video in surgical hand wash.

BACKGROUND: Video-based instructions for clinical procedures have been used frequently during the preceding decades. AIM: To investigate in a randomised controlled trial the learning effectiveness of fragmented videos vs. the complete sequential video and to analyse the attitudes of the user towards video as a learning aid. MATERIALS AND METHODS: An instructional video on surgical hand wash was produced. The video was available in two different forms in two separate web pages: one as a sequential video and one fragmented into eight short clips. Twenty-eight dental students in the second semester were randomised into an experimental (n = 15) and a control group (n = 13). The experimental group used the fragmented form of the video and the control group watched the complete one. The use of the videos was logged and the students were video taped whilst undertaking a test hand wash. The videos were analysed systematically and blindly by two independent clinicians. The students also performed a written test concerning learning outcome from the videos as well as they answered an attitude questionnaire. RESULTS: The students in the experimental group watched the video significantly longer than the control group. There were no significant differences between the groups with regard to the ratings and scores when performing the hand wash. The experimental group had significantly better results in the written test compared with those of the control group. There was no significant difference between the groups with regard to attitudes towards the use of video for learning, as measured by the Visual Analogue Scales. Most students in both groups expressed satisfaction with the use of video for learning. CONCLUSION: The students demonstrated positive attitudes and acceptable learning outcome from viewing CAL videos as a part of their pre-clinical training. Videos that are part of computer-based learning settings would ideally be presented to the students both as a segmented and as a whole video to give the students the option to choose the form of video which suits the individual student's learning style.

Attitude of Health Personnel↗

PubMed1998

A fitness programme for patients with chronic low back pain: 2-year follow-up of a randomised controlled trial.

The aim of this study was to assess the long-term effect of a supervised fitness programme on patients with chronic low back pain. The design of the study was a single blind randomised controlled trial with follow-up, by postal questionnaire, 2 years after intervention. The Oswestry Low Back Pain Disability Index was used as the outcome measure to assess daily activity affected by back pain. Eighty-one patients with chronic low back pain, who were referred to the physiotherapy department of a National Health Service orthopaedic hospital, were randomised to either a supervised fitness programme or a control group. Patients in the intervention group and control group were taught specific exercises to be continued at home and referred to a backschool for back care education. In addition, the intervention group attended eight sessions of a supervised fitness programme. Sixty-two patients (76%) with a mean age of 37 years, returned the Oswestry Low Back Pain Disability Index questionnaire. Of these, 29 were in the intervention group and 31 in the control group. Patients in the intervention group demonstrated a mean reduction of 7.7% in the Oswestry Low Back Pain Disability Index score (95% confidence interval of mean paired difference 3.9, 11.6 P < 0.001), compared with only 2.4% in the control group (95% confidence interval of mean paired difference -2.0, 6.9 P > 0.05). Between group comparisons demonstrated a statistically significant difference in disability scores between the treatment and control group (mean difference 5.8, 95% confidence interval 0.3, 11.4 P < 0.04). This study supports the current trend towards a more active treatment approach to low back pain. We have demonstrated clinical effectiveness of a fitness programme 2 years after treatment but this needs to be replicated in a larger study which should include a cost effectiveness analysis, further analysis of objective functional status and a placebo intervention group.

Adolescent↗

PubMed1992

Randomised controlled trial of cost-effectiveness of lithotripsy and open cholecystectomy as treatments for gallbladder stones.

Inpatient extracorporeal shockwave lithotripsy for treatment of gallbladder stones has not previously been compared with open cholecystectomy in terms of cost-effectiveness. In a randomised controlled trial, 163 patients, stratified by gallstone bulk (over 4 cm3 or not), were randomised to lithotripsy or cholecystectomy (38 large-bulk and 27 small-bulk cholecystectomy; 37 large-bulk and 61 small-bulk lithotripsy) and followed up for 1 year. Both treatments gave significant health gains in terms of a reduction in episodes of biliary pain, improved perceived health status, and symptom relief, but few differences between treatments were found. There was some evidence that biliary-pain episodes were less severe after cholecystectomy. Cholecystectomy patients also had greater improvements in mean health gain for three related symptoms: vomiting, feeling sick, and fatty-food upset. However, there were no differences between groups in perceived health status. Among lithotripsy patients, health gain was not related to stone clearance. Lithotripsy was more expensive than cholecystectomy, principally because of the costs of the inpatient stay and adjuvant bile-salt therapy. Conventional lithotripsy appears at least as cost-effective as cholecystectomy for patients with small-bulk stones but less cost-effective for those with large-bulk stones. To some extent treatment choice can be guided by patient preference.

Adult↗

PubMed2003

Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial.

BACKGROUND: A recent Cochrane review of reality orientation therapy identified the need for large, well-designed, multi-centre trials. AIMS: To test the hypothesis that cognitive stimulation therapy (CST) for older people with dementia would benefit cognition and quality of life. METHOD: A single-blind, multi-centre, randomised controlled trial recruited 201 older people with dementia. The main outcome measures were change in cognitive function and quality of life. An intention-to-treat analysis used analysis of covariance to control for potential variability in baseline measures. RESULTS: One hundred and fifteen people were randomised within centres to the intervention group and 86 to the control group. At follow-up the intervention group had significantly improved relative to the control group on the Mini-Mental State Examination (P=0.044), the Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog) (P=0.014) and Quality of Life - Alzheimer's Disease scales (P=0.028). Using criteria of 4 points or more improvement on the ADAS-Cog the number needed to treat was 6 for the intervention group. CONCLUSION: The results compare favourably with trials of drugs for dementia. CST groups may have worthwhile benefits for many people with dementia.

Aged↗

PubMed2006

Randomised controlled trial comparing three methods of presenting risk of Down's syndrome.

OBJECTIVE: To compare three simple methods of presenting information to patients about the risk of Down's syndrome. STUDY DESIGN: Randomised controlled trial of 150 " low risk" women booking for antenatal care before 19 weeks gestation at Sunderland Royal Hospital. After informing the women about the purpose of the study and reassuring them that they were "low risk", each patient was given a questionnaire, which used one of three different methods (graphic, written and interactive) to present information about the risk of Down's syndrome. A visual analogue scale allowed us to assess their level of understanding and anxiety before and after the information about risk was given to them. RESULTS: All three methods significantly altered patients' perception and anxiety about the risk of Down's syndrome. The interactive method was found to be the most effective of the three. CONCLUSION: This pilot study suggests that discussing the patients' worries about fetal anomalies with medical staff can markedly reduce their degree of anxiety. The interactive method was most effective at putting information across to the patient. It significantly reduced their level of anxiety as well as their overall worry about pregnancy.

Adolescent↗

PubMed2006

Does additional support by nurses enhance the effect of a brief smoking cessation intervention in people with moderate to severe chronic obstructive pulmonary disease? A randomised controlled trial.

BACKGROUND: Smoking cessation is the primary disease modifying intervention for chronic obstructive pulmonary disease (COPD). SETTING: A Regional Respiratory Centre (RRC) out-patient department in Northern Ireland. METHODS: A randomised controlled trial (RCT) evaluated the effectiveness of brief advice alone or accompanied by individual nurse support or group support facilitated by nurses. Smoking status was biochemically validated and stage of change, nicotine addiction and dyspnoea were recorded at 2, 3, 6, 9 and 12 months. PARTICIPANTS: Ninety-one cigarette smokers with COPD were enrolled in the study (mean age 61 years, 47 female). RESULTS: After 12 months cessation rates were not significantly different between groups (p=0.7), but all groups had a significant reduction in their nicotine addiction (p=0.03-0.006). No changes in subjects' motivation or dyspnoea were detected over the 12 months. CONCLUSION: Patients with COPD were unable to stop smoking regardless of the type of support they received. Harm reduction may be a more appropriate goal than complete cessation for intractable smokers and nurses must evaluate their role in this arena.

Analysis of Variance↗