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Results for “Randomised Controlled Trial”

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PubMed2002

"Walk in to Work Out": a randomised controlled trial of a self help intervention to promote active commuting.

STUDY OBJECTIVE: To determine if a self help intervention, delivered via written interactive materials (the "Walk in to Work Out" pack), could increase active commuting behaviour (walking and cycling). DESIGN: Randomised controlled trial. The intervention group received the "Walk in to Work Out" pack, which contained written interactive materials based on the transtheoretical model of behaviour change, local information about distances and routes, and safety information. The control group received the pack six months later. Focus groups were also conducted after six months. SETTING: Three workplaces in the city of Glasgow, Scotland, UK. PARTICIPANTS: 295 employees who had been identified as thinking about, or doing some irregular, walking or cycling to work. MAIN RESULTS: The intervention group was almost twice as likely to increase walking to work as the control group at six months (odds ratio of 1.93, 95% confidence intervals 1.06 to 3.52). The intervention was not successful at increasing cycling. There were no distance travelled to work, gender, or age influences on the results. Twenty five per cent (95% confidence intervals 17% to 32%) of the intervention group, who received the pack at baseline, were regularly actively commuting at the 12 month follow up. CONCLUSION: The "Walk in to Work Out" pack was successful in increasing walking but not cycling. The environment for cycling must be improved before cycling will become a popular option.

Adult↗

PubMed2004

Randomised controlled trial of health assessments for older Australian veterans and war widows.

OBJECTIVE: To assess the effect of home-based health assessments for older Australians on health-related quality of life, hospital and nursing home admissions, and death. DESIGN: Randomised controlled trial of the effect of health assessments over 3 years. PARTICIPANTS AND SETTING: 1569 community-living veterans and war widows receiving full benefits from the Department of Veterans' Affairs and aged 70 years or over were randomly selected in 1997 from 10 regions of New South Wales and Queensland and randomly allocated to receive either usual care (n = 627) or health assessments (n = 942). INTERVENTION: Annual or 6-monthly home-based health assessments by health professionals, with telephone follow-up, and written report to a nominated general practitioner. MAIN OUTCOME MEASURES: Differences in health-related quality of life, admission to hospital and nursing home, and death over 3 years of follow-up. RESULTS: 3-year follow-up interviews were conducted for 1031 participants. Intervention-group participants who remained in the study reported higher quality of life than control-group participants (difference in Physical Component Summary score, 0.90; 95% CI, 0.05-1.76; difference in Mental Component Summary score, 1.36; 95% CI, 0.40-2.32). There was no significant difference in the probability of hospital admission or death between intervention and control groups over the study period. Significantly more participants in the intervention group were admitted to nursing homes compared with the control group (30 v 7; P < 0.01). CONCLUSIONS: Health assessments for older people may have small positive effects on quality of life for those who remain resident in the community, but do not prevent deaths. Assessments may increase the probability of nursing-home placement.

Aged↗

PubMed2006

Randomised controlled trial of a parenting intervention in the voluntary sector for reducing child conduct problems: outcomes and mechanisms of change.

BACKGROUND: To test effectiveness of a parenting intervention, delivered in a community-based voluntary-sector organisation, for reducing conduct problems in clinically-referred children. METHODS: Randomised controlled trial, follow-up at 6, 18 months, assessors blind to treatment status. Participants--76 children referred for conduct problems, aged 2-9, primarily low-income families, randomised to treatment vs. 6-month wait-list group. Retention was 93% at 6 months, 90% at 18 months. Interventions--Webster-Stratton Incredible Years video-based 14-week group programme, teaches cognitive-behavioural principles for managing behaviour, using a collaborative, practical, problem-solving approach. Primary outcomes--child problem behaviour by parent-report (Eyberg) and home-based direct observation; secondary outcomes--observed positive and negative parenting; parent-reported parenting skill, confidence and depression. RESULTS: Post-treatment improvements were found in child problem behaviour, by parent-report (effect size (ES) .48, p = .05) and direct observation (ES .78, p = .02); child independent play (ES .77, p = .003); observed negative (ES .74, p = .003) and positive (ES .38, p = .04) parenting; parent-reported confidence (ES .40, p = .03) and skill (ES .65, p =.01), using ANCOVA to control for baseline scores. Maternal depression did not change. Consumer satisfaction was high. At 18-month follow-up, although no randomised comparison was possible, changes appeared to maintain, with no significant change toward baseline level on any measure. Change in observed positive parenting appeared to mediate change in child problem behaviour (p < .025). CONCLUSIONS: Findings suggest that a group-based cognitive-behavioural parenting programme, delivered by well-trained and supervised staff, can be effective in a community voluntary-sector setting, for reducing conduct problems and enhancing parenting skills. Change in parenting skill appears to be a key mechanism for change in child behaviour. Findings have implications for feasibility of translating evidence-based programmes, even for clinically-referred conduct problems, into less specialised community settings, likely to have lower costs and be more accessible for families.

Child↗

PubMed2005

Randomised controlled trial comparing efficacy of same day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36- to 48-hour protocol.

HYPOTHESIS: That a 6-hour drug administration interval has similar efficacy and greater patient satisfaction as a 36- to 48-hour interval. SAMPLE: Four hundred and fifty patients. METHODS: A two-arm parallel design unblended randomised controlled trial in a single hospital. Eligible women up to 63 days of gestation will be invited to participate. Those willing will be randomised to either the experimental group (6 hours administration of misoprostol) or the control group (36-48 hours administration of misoprostol). All participants will take 200 mg mifepristone orally. At the time determined by study group allocation 800 microg misoprostol will be given intravaginally together with 100 mg diclofenac pr. Antibiotic prophylaxis as per the usual protocol will be given to each group. The control group will remain in hospital for 6 hours as per current policy and the study group will return home in 1 to 3 hours. MAIN OUTCOME MEASURE: Complete medical abortion without need for further misoprostol or surgical evacuation. SECONDARY OUTCOMES: Duration of bleeding, side effects and acceptability based on questionnaire. FUNDING SOURCE: None.

Abortifacient Agents, Nonsteroidal↗

PubMed1997

The effectiveness of exercise training in lowering blood pressure: a meta-analysis of randomised controlled trials of 4 weeks or longer.

OBJECTIVE: To identify the features of an optimal exercise programme in terms of type of exercise, intensity and frequency that would maximise the training induced decrease in blood pressure (BP). DATA IDENTIFICATION: Trials were identified by a systematic search of Medline, Embase and Science Citation Index (SCI), previous review articles and the references of relevant trials, from 1980 until 1996, including only English language studies. STUDY SELECTION: The inclusion criteria were limited to randomised controlled trials of aerobic or resistance exercise training conducted over a minimum of 4 weeks where systolic and diastolic BP was measured. RESULTS: A total of 29 studies (1533 hypertensive and normotensive participants) were included, 26 used aerobic exercise training, two trials used resistance training and one study had both resistance and aerobic training groups. Aerobic exercise training reduced systolic BP by 4.7 mm Hg (95% CI: 4.4, 5.0) and diastolic BP by 3.1 mm Hg (95% CI: 3.0, 3.3) as compared to a non-exercising control group, however, significant heterogeneity was observed between trials in the analysis. The BP reduction seen with aerobic exercise training was independent of the intensity of exercise and the number of exercise sessions per week. The evidence for the effect of resistance exercise training was inconclusive. CONCLUSIONS: Aerobic exercise training had a small but clinically significant effect in reducing systolic and diastolic BP. Increasing exercise intensity above 70% VO2 max or increasing exercise frequency to more than three sessions per week did not have any additional impact on reducing BP.

Adolescent↗

PubMed2001

Randomised controlled trial of cardiotocography versus Doppler auscultation of fetal heart at admission in labour in low risk obstetric population.

OBJECTIVE: To compare the effect of admission cardiotocography and Doppler auscultation of the fetal heart on neonatal outcome and levels of obstetric intervention in a low risk obstetric population. DESIGN: Randomised controlled trial. SETTING: Obstetric unit of teaching hospital PARTICIPANTS: Pregnant women who had no obstetric complications that warranted continuous monitoring of fetal heart rate in labour. INTERVENTION: Women were randomised to receive either cardiotocography or Doppler auscultation of the fetal heart when they were admitted in spontaneous uncomplicated labour. MAIN OUTCOME MEASURES: The primary outcome measure was umbilical arterial metabolic acidosis. Secondary outcome measures included other measures of condition at birth and obstetric intervention. RESULTS: There were no significant differences in the incidence of metabolic acidosis or any other measure of neonatal outcome among women who remained at low risk when they were admitted in labour. However, compared with women who received Doppler auscultation, women who had admission cardiotocography were significantly more likely to have continuous fetal heart rate monitoring in labour (odds ratio 1.49, 95% confidence interval 1.26 to 1.76), augmentation of labour (1.26, 1.02 to 1.56), epidural analgesia (1.33, 1.10 to 1.61), and operative delivery (1.36, 1.12 to 1.65). CONCLUSIONS: Compared with Doppler auscultation of the fetal heart, admission cardiotocography does not benefit neonatal outcome in low risk women. Its use results in increased obstetric intervention, including operative delivery.

Acidosis↗

PubMed2003

Extracorporeal shock wave therapy for plantar fasciitis. A double blind randomised controlled trial.

BACKGROUND: Extracorporeal shock wave therapy (ESWT) is an increasingly popular therapeutic approach in the management of a number of tendinopathies. Benefit has been shown in calcific tendinitis of the rotator cuff, but evidence for its use in non-calcific disorders is limited. AIMS: To perform a double blind randomised controlled trial of moderate dose shock wave therapy in plantar fasciitis. METHODS: Adults with plantar fasciitis for at least 3 months were randomised to receive either active treatment (0.12 mJ/mm(2)) or sham therapy, monthly for 3 months. Pain in the day, nocturnal pain and morning start-up pain were assessed at baseline, before each treatment and 1 and 3 months after completion of therapy. RESULTS: Eighty-eight subjects participated and no differences existed between the groups at baseline. At 3 months, 37% of the subjects in the ESWT group and 24% in the sham group showed a positive response (50% improvement from baseline) with respect to pain. Positive responses in night pain occurred in 41% and 31% in the ESWT and sham groups, respectively. Positive responses in start-up pain occurred in 37% and 36% in the ESWT and sham groups, respectively. Both groups showed significant improvement over the course of the study, but no statistically significant difference existed between the groups with respect to the changes were seen in any of the outcome measures over the 6-month period. CONCLUSIONS: There appears to be no treatment effect of moderate dose ESWT in subjects with plantar fasciitis. Efficacy may be highly dependent upon machine types and treatment protocols. Further research is needed to develop evidence based recommendation for the use ESWT in musculoskeletal complaints.

Adult↗

PubMed2026

Transabdominal lumbar approach (TALA) versus retroperitoneal approach for robot-assisted renal surgery: a prospective randomised controlled trial.

PURPOSE: Common robotic nephrectomy approaches access the kidney via transperitoneal (TP) or retroperitoneal (RP) routes, each with distinct trade-offs. We developed the transabdominal lumbar approach (TALA), combining advantages of both accesses with improved visualisation and strategic trocar placement, and compared it with conventional RP in a prospective randomised controlled trial using technique-oriented intraoperative endpoints. METHODS: In this single-centre, prospective, open-label RCT, 40 patients were randomised to TALA (n = 18) or conventional RP (n = 22). Eligible patients were ≥ 18 years with a renal tumour or non-functional kidney requiring robot-assisted total or partial nephrectomy. Exclusions included prior surgery on the affected kidney, renal vein tumour thrombus, and pregnancy. Both groups were followed for 30 days. The primary endpoint was time from first skin incision to renal artery identification. RESULTS: TALA achieved a median time saving of 16 min compared to conventional RP (38 vs. 54 min, p = 0.001). Perioperative safety was comparable between groups, with three patients (7.5%) experiencing Clavien-Dindo grade III-IV complications. CONCLUSIONS: TALA met its primary endpoint with a significantly shorter time to renal artery identification than conventional RP access, and improving perceived surgical exposure and instrument handling.

Humans↗

PubMed1984

Randomised controlled trial of effect of raw and holder pasteurised human milk and of formula supplements on incidence of neonatal infection.

Supplementary formula feeds inhibited the protective effect of expressed raw and pasteurised human milk in 226 high-risk neonates in a randomised controlled trial. The infection rate in the group given pasteurised human milk and formula (33%) was significantly higher than the rates in the groups given raw human milk (10.5%), pasteurised human milk (14.3%), and raw human milk and formula (16%). This accords with the impressions that some of the association of infection with artificial feeding is partly attributable to the lack of the protective effect of human milk. Heating expressed human milk to 62.5 degrees C for 30 min significantly reduces its protective effect.

Animals↗

PubMed1997

Randomised controlled trial of cardiotocography versus umbilical artery Doppler in the management of small for gestational age fetuses.

OBJECTIVE: To compare the impact on use of resources in the management of small for gestational age babies using Doppler ultrasound versus cardiotocography. DESIGN: A randomised controlled trial. SETTING: A large district general hospital delivering 5500 to 6000 infants each year, 30% to 35% of which are to women of Pakistani origin. POPULATION: One hundred and fifty women delivered of small for gestational age infants. MAIN OUTCOME MEASURES: Primary outcome measures were length of hospital inpatient stay and induction of labour rates. Secondary outcome measures included caesarean section rates and length of stay on neonatal unit. RESULTS: The use of Doppler reduced average hospital inpatient stay from 2.5 days to 1.1 days, compared with cardiotocography (P = 0.036). There was no effect on induction of labour rates or caesarean section rates. There was no significant difference in length of stay on the neonatal unit (P = 0.33). There was a reduction in monitoring frequency and fewer hospital antenatal clinic visits. CONCLUSION: The use of Doppler ultrasound to manage small for gestational age infants reduces the use of resources, compared with cardiotocography.

Cardiotocography↗

PubMed1998

A randomised controlled trial of care of the perineum during second stage of normal labour.

OBJECTIVE: To compare the effect of two methods of perineal management used during spontaneous vaginal delivery on the prevalence of perineal pain reported at 10 days after birth. DESIGN: Randomised controlled trial. SETTING: Two English maternity care units. SAMPLE: 5471 women who gave birth between December 1994 and December 1996. METHODS: At the end of the second stage of labour women were allocated to either the 'hands on' method, in which the midwife's hands put pressure on the baby's head and support ('guard') the perineum; lateral flexion is then used to facilitate delivery of the shoulders, or the 'hands poised' method, in which the midwife keeps her hands poised, not touching the head or perineum, allowing spontaneous delivery of the shoulders. MAIN OUTCOME MEASURE: Perineal pain in the previous 24 hours reported by women in self-administered questionnaire 10 days after birth. RESULTS: Questionnaires were completed by 97% of women at 10 days after birth. 910 (34.1%) women in the 'hands poised' group reported pain in the previous 24 hours compared with 823 (31.1%) in the 'hands on' group (RR 1.10, 95% CI 1.01 to 1.18: absolute difference 3%, 0.5% to 5%, P = 0.02). The rate of episiotomy was significantly lower in the 'hands poised' group (RR 0.79, 99% CI 0.65 to 0.96, P = 0.008) but the rate of manual removal of placenta was significantly higher (RR 1.69, 99% CI 1.02 to 2.78; P = 0.008). There were no other statistically significant differences detected between the two methods. CONCLUSION: The reduction in pain observed in the 'hands on' group was statistically significant and the difference detected potentially affects a substantial number of women. These results provide evidence to enable individual women and health professionals to decide which perineal management is preferable.

Adult↗

PubMed1997

Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women.

OBJECTIVE: To assess the effectiveness of a home exercise programme of strength and balance retraining exercises in reducing falls and injuries in elderly women. DESIGN: Randomised controlled trial of an individually tailored programme of physical therapy in the home (exercise group, n = 116) compared with the usual care and an equal number of social visits (control group, n = 117). SETTING: 17 general practices in Dunedin, New Zealand. SUBJECTS: Women aged 80 years and older living in the community and registered with a general practice in Dunedin. MAIN OUTCOME MEASURES: Number of falls and injuries related to falls and time between falls during one year of follow up; changes in muscle strength and balance measures after six months. RESULTS: After one year there were 152 falls in the control group and 88 falls in the exercise group. The mean (SD) rate of falls was lower in the exercise than the control group (0.87 (1.29) v 1.34 (1.93) falls per year respectively; difference 0.47; 95% confidence interval 0.04 to 0.90). The relative hazard for the first four falls in the exercise group compared with the control group was 0.68 (0.52 to 0.90). The relative hazard for a first fall with injury in the exercise group compared with the control group was 0.61 (0.39 to 0.97). After six months, balance had improved in the exercise group (difference between groups in change in balance score 0.43 (0.21 to 0.65). CONCLUSIONS: An individual programme of strength and balance retraining exercises improved physical function and was effective in reducing falls and injuries in women 80 years and older.

Accidental Falls↗

PubMed1993

Problems with implementing guidelines: a randomised controlled trial of consensus management of dyspepsia.

OBJECTIVE: To determine the feasibility and benefit of developing guidelines for managing dyspepsia by consensus between general practitioners (GPs) and specialists and to evaluate their introduction on GPs' prescribing, use of investigations, and referrals. DESIGN: Randomised controlled trial of effect of consensus guidelines agreed between GPs and specialists on GPs' behaviour. SETTING: Southampton and South West Hampshire Health District, United Kingdom. SUBJECTS: 179 GPs working in 45 practices in Southampton district out of 254 eligible GPs, 107 in the control group and 78 in the study group. MAIN MEASURES: Rates of referral and investigation and costs of prescribing for dyspepsia in the six months before and after introduction of the guidelines. RESULTS: Consensus guidelines were produced relatively easily. After their introduction referral rates for upper gastrointestinal symptoms fell significantly in both study and control groups, but no significant change occurred in either group in the use of endoscopy or radiology, either in terms of referral rates, patient selection, or findings on investigation. No difference was observed between the control and study group in the number of items prescribed, but prescribing costs rose by 25% (from 2634 pounds to 3215 pounds per GP) in the study group, almost entirely due to an increased rate of prescription of ulcer-healing agents. CONCLUSION: Developing district guidelines for managing dyspepsia by consensus between GPs and specialists was feasible. However, their acceptance and adoption was variable and their measured effects on some aspects of clinical behaviour were relatively weak and not necessarily associated with either decreased costs or improved quality of care.

Data Collection↗

PubMed1997

Acute and one-year outcome of a randomised controlled trial of brief cognitive therapy for major depressive disorder in primary care.

BACKGROUND: The consensus statement on the treatment of depression (Paykel & Priest, 1992) advocates the use of cognitive therapy techniques as an adjunct to medication. METHOD: This paper describes a randomised controlled trial of brief cognitive therapy (BCT) plus 'treatment as usual' versus treatment as usual in the management of 48 patients with major depressive disorder presenting in primary care. RESULTS: At the end of the acute phase, significantly more subjects (P < 0.05) met recovery criteria in the intervention group (n = 15) compared with the control group (n = 8). When initial neuroticism scores were controlled for, reductions in Beck Depression Inventory and Hamilton Rating Scale for Depression scores favoured the BCT group throughout the 12 months of follow-up. CONCLUSIONS: BCT may be beneficial, but given the time constraints, therapists need to be more rather than less skilled in cognitive therapy. This, plus methodological limitations, leads us to advise caution before applying this approach more widely in primary care.

Acute Disease↗

PubMed2004

Cognitive therapy for the prevention of psychosis in people at ultra-high risk: randomised controlled trial.

BACKGROUND: Advances in the ability to identify people at high risk of developing psychosis have generated interest in the possibility of preventing psychosis. AIMS: To evaluate the efficacy of cognitive therapy for the prevention of transition to psychosis. METHOD: A randomised controlled trial compared cognitive therapy with treatment as usual in 58 patients at ultra-high risk of developing a first episode of psychosis. Therapy was provided over 6 months, and all patients were monitored on a monthly basis for 12 months. RESULTS: Logistic regression demonstrated that cognitive therapy significantly reduced the likelihood of making progression to psychosis as defined on the Positive and Negative Syndrome Scale over 12 months. In addition, it significantly reduced the likelihood of being prescribed antipsychotic medication and of meeting criteria for a DSM-IV diagnosis of a psychotic disorder. Analysis of covariance showed that the intervention also significantly improved positive symptoms of psychosis in this population over the 12-month period CONCLUSIONS: Cognitive therapy appears to be an acceptable and efficacious intervention for people at high risk of developing psychosis.

Adolescent↗

PubMed2001

A randomised controlled trial of the outcome of health assessment of people aged 75 years and over.

OBJECTIVES: To measure the outcomes of a health assessment, conducted by a nurse, of people aged 75 years and older (75+HA) living independently in their own homes. DESIGN: Randomised controlled trial (RCT). SETTING: A convenience sample of six general practices within the Adelaide Western Division of General Practice (AWDGP). A random sample of 100 participants was drawn from practice age-sex registers. Data were collected in initial visits between 1 August 1998 and February 1999, then in follow-up visits one year later. PARTICIPANTS: Participants were aged 75 years and over on 1 August 1998 and living independently in the community. 145 eligible patients were invited to join the study, and 100 of these consented to enrol (69%). INTERVENTION: A 75+HA conducted in the participant's home by a nurse and reported to their usual general practitioner. MAIN OUTCOME MEASURES: Primary: number of problems in each group; number of participants with problems; and mortality. Secondary: physical function; psychological (including cognitive) function; falls; and admission to institution. RESULTS: There were no significant differences between the control and intervention groups at follow-up in the number of problems, the number of participants with problems, or mortality. In the intervention group, there was significant improvement in self-rated health, geriatric depression score (GDS 15), and number of falls. CONCLUSIONS: This RCT has not demonstrated improvement in health status of the intervention group which received a 75+HA compared with a control group left to usual care.

Activities of Daily Living↗

PubMed2004

Using randomised controlled trials (RCTs) to test service interventions: issues of standardisation, selection and generalisability.

The commissioning of healthcare services is increasingly linked to the availability of rigorous evidence of clinical and cost effectiveness. In the current climate, 'rigorous evidence' is synonymous with the randomised controlled trial (RCT). Consequently, health technologies are often funded in preference to service developments due to an imbalance in the availability of strong evidence to support service developments. Simultaneously, there is an increasing policy emphasis on patient choice and individualized care in the NHS. In this paper Bill Watson, Susan Procter and Wendy Cochrane discuss the implications of using experimental methods in service development research, with reference to an ongoing RCT evaluating the component parts of pulmonary rehabilitation in people with chronic obstructive pulmonary disease (COPD).

Bias↗

PubMed2002

Patient and carer satisfaction with 'hospital at home': quantitative and qualitative results from a randomised controlled trial.

BACKGROUND: 'Hospital At Home' schemes are set to increase in the United Kingdom (UK) in response to the NHS Plan. To date, little detailed work has been done on the acceptability of these schemes to patients and their carers. AIM: To compare Hospital at Home patient and carer satisfaction with hospital care. DESIGN OF STUDY: Pragmatic randomised controlled trial. SETTING: Consecutive patients assessed as suitablefor the Leicester Hospital at Home scheme were randomised to Hospital at Home or one of three acute hospitals in the city. METHOD: Patient satisfaction was assessed two weeks after randomisation, or at discharge if later using a six-item questionnaire. Patients' and carers' views of the services were assessed by semistructured interviews. RESULTS: One hundred and two patients were randomised to Hospital at Home and 97 to hospital. Forty-eight (47%) patients in the Hospital at Home arm and 35 (36%) in the hospital arm completed the satisfaction questionnaire, representing 96% and 85% of those eligible, respectively. Total scores were significantly higher in the Hospital at Home (median = 15) than in the hospital group (median = 12). (P<0.001, Mann-Whitney U-test.) Responses to all six questions favoured Hospital at Home, with all but one of these differences being statistically significant. In the Hospital at Homegroup, 24 patients and 18 of their carers were interviewed; in the hospital group 18 patients and seven of their carers were interviewed. Themes emerging from these interviews were that patients appreciated the more personal care and better communication offered by Hospital at Home and placed great value on staying at home, which was seen to be therapeutic. Patients largely felt safe in Hospital at Home, although some would have felt safer in hospital. Some patients and carers felt that better medical care would have been provided in hospital. Carers felt that the workload imposed by Hospital at Home was no greater than by hospital admission and that the relief from care duties at home would be counterbalanced by the added strain of hospital visiting. CONCLUSIONS: Patient satisfaction was greater with Hospital at Home than with hospital. Reasons included a more personal style of care and a feeling that staying at home was therapeutic. Carers did not feel that Hospital at Home imposed an extra workload.

Aged↗