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Results for “Randomised Controlled Trial”

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PubMed2000

A randomised controlled trial of flexibility in routine antenatal care.

OBJECTIVE: To assess changes in satisfaction associated with a flexible approach to antenatal care schedules offered to women at low obstetric risk. DESIGN: Randomised controlled trial. SETTING: Eleven primary care centres providing midwifery care in Avon. PARTICIPANTS: Six hundred and nine women at low risk of obstetric complications presenting for antenatal care. METHODS: A standard antenatal care schedule ('traditional care') was compared with a schedule based on a minimum number of visits and additional visits with timing agreed between women and midwives ('flexible care'). MAIN OUTCOME MEASURES: Women's attitudes to pregnancy and motherhood using a subscale of the Maternal Adjustment and Maternal Attitudes scale, satisfaction with antenatal care, and perception of the speed of recognition of antenatal complications. RESULTS: There was no difference between the two groups in terms of attitudes to pregnancy and motherhood (mean difference on Maternal Adjustment and Maternal Attitudes scale -0.64, 95% CI -1.39 to 0.11, P = 0.068) and no difference in the proportions of women reporting antenatal problems as soon as possible (traditional group 74.5%, flexible group 76.4%, difference -2%, 95% CI -12.1 to 8.2, P = 0.70). Women receiving traditional care reported higher levels of satisfaction for the care provided by community midwives (P < 0.01). Women receiving flexible care were more likely to report having a choice over the number and timing of their antenatal visits (P < 0.001), but were also more likely to report that they would like to have been seen more often (P < 0.01). There was no difference between the groups in rates of obstetric complications. CONCLUSIONS: An imposed reduction in antenatal visits has been reported to increase dissatisfaction in other studies. In this study, encouraging women to adopt a flexible approach to antenatal care resulted in a similar finding. Successful implementation of such approaches may depend on more careful selection of women who welcome such an approach, more encouragement to pregnant women to express their own needs and greater feelings of commitment on the part of the care providers.

Adaptation, Psychological↗

PubMed2005

A randomised controlled trial of moxibustion for breech presentation.

OBJECTIVES: To evaluate the efficacy of moxibustion for the correction of fetal breech presentation in a non-Chinese population. DESIGN: Single-blind randomised controlled trial (RCT). SETTING: Six obstetric departments in Italy. SAMPLE: Healthy non-Chinese nulliparous pregnant women at 32-33 weeks + 3 days of gestational age with the fetus in breech presentation. METHODS: Random assignment to treatment or observation. Treatment consisted of moxibustion (stimulation with heat from a stick of Artemisia vulgaris) at the BL 67 acupuncture point (Zhiyin) for one or two weeks. Two weeks after recruitment, each participant was subjected to an ultrasonic examination of the fetal presentation. MAIN OUTCOME MEASURE: Number of participants with cephalic presentation in the 35th week. RESULTS: The study was interrupted when 123 participants had been recruited (46% of the planned sample). Intermediate data monitoring revealed a high number of treatment interruptions. At this point no difference was found in cephalic presentation in the 35th week (treatment group: 22/65, 34%; control group: 21/58, 36%; RR 0.95; 99% CI 0.59-1.5). CONCLUSIONS: The results underline the methodological problems evaluating of a traditional treatment transferred from a different cultural context. They do not support either the effectiveness or the ineffectiveness of moxibustion in correcting fetal breech presentation.

Adult↗

PubMed2006

A randomised controlled trial comparing outpatient versus daycase endometrial polypectomy.

OBJECTIVE: To evaluate outpatient versus daycase endometrial polypectomy by comparing success rate, complications, patient tolerance, pain score, analgesia requirement and recovery. DESIGN: A randomised controlled trial. SETTING: A large UK Teaching hospital. POPULATION: Forty consecutive women diagnosed with an endometrial polyp at outpatient hysteroscopy were randomly assigned in equal proportions to outpatient or daycase polyp removal. METHODS: The outpatient cohort underwent endometrial polypectomy either using grasping forceps or a bipolar electrode (Versapoint; Gynecare Inc., Menlo Park, CA, USA) introduced down the operating channel of a rigid hysteroscope (Versascope; Gynecare Inc.). The daycase cohort underwent traditional endometrial polyp resection using a hysteroscopic, monopolar, electrosurgical resecting loop, performed under general anaesthetic. MAIN OUTCOME MEASURES: The main outcome measures were as follows: success rates and intra or postoperative complications, time away from home, analgesia requirements, pain scores on the day of and one day after endometrial polypectomy, return to work and preoperative fitness and preference for the location of a future endometrial polypectomy. RESULTS: The majority of women from both cohorts were premenopausal (62.5%), parous (85%) and in paid employment (62.5%). One woman allocated to outpatient polypectomy had cervical stenosis and dilatation was unsuccessful in the outpatient setting. There were no other intra or postoperative complications in either arm of the study. The mean intraoperative visual analogue style (0-100 mm) pain score during outpatient polypectomy was 23.7 mm (1-62). A proportion of women (20%) described no intraoperative discomfort; however, the majority (75%) described mild or moderate intraoperative discomfort. More women in the outpatient cohort (58%) described themselves as pain free for the remainder of the day than in the daycase cohort (28%) (P= 0.09). The day after the procedure, all women from the outpatient group described slight or no discomfort compared with only 41% of women from the daycase group (P= 0.02). All women undergoing outpatient polypectomy had a significantly shorter mean time away from home (3.24 [1.5-5] hours) than women undergoing daycase polypectomy (7.42 [6-10.5] hours), P < 0.0005. Similarly, women from the outpatient cohort had a significantly faster mean return to preoperative fitness (1 [0-4] day versus 3.2 [1-13] days; P= 0.001) and required less postoperative analgesia than the daycase cohort. Ninety-five percent of women from the outpatient cohort and 82% of women from the daycase cohort stated they would prefer to undergo an endometrial polypectomy in the outpatient setting should they require a further polyp removal. CONCLUSION: Endometrial polypectomy can be successfully performed in the outpatient setting with minimal intraoperative discomfort, a significantly shorter time away from home and faster recovery and is preferred by women when compared with daycase polypectomy. Resources need to be made rapidly available to undertake larger scale research and develop this service across the UK.

Adult↗

PubMed1995

Randomised controlled trial for evaluation of fitness programme for patients with chronic low back pain.

OBJECTIVE: To evaluate a progressive fitness programme for patients with chronic low back pain. DESIGN: Single blind randomised controlled trial. Assessments were carried out before and after treatment by an observer blinded to the study and included a battery of validated measures. All patients were followed up by postal questionnaire six months after treatment. SETTING: Physiotherapy department of orthopaedic hospital. SUBJECTS: 81 patients with chronic low back pain referred from orthopaedic consultants for physiotherapy. The patients were randomly allocated to a fitness programme or control group. INTERVENTION: Both groups were taught specific exercises to carry out at home and referred to a back-school for education in back care. Patients allocated to the fitness class attended eight exercise classes over four weeks in addition to the home programme and backschool. RESULTS: Significant differences between the groups were shown in the changes before and after treatment in scores on the Oswestry low back pain disability index (P < 0.005), pain reports (sensory P < 0.05 and affective P < 0.005), self efficacy reports (P < 0.05), and walking distance (P < 0.005). No significant differences between the groups were found by the general health questionnaire or questionnaire on pain locus of control. A benefit of about 6 percentage points on the disability index was maintained by patients in the fitness group at six months. CONCLUSION: There is a role for supervised fitness programmes in the management of moderately disabled patients with chronic low back pain. Further clinical trials, however, need to be established in other centres to confirm these findings.

Adult↗

PubMed1997

Comparison of out of hours care provided by patients' own general practitioners and commercial deputising services: a randomised controlled trial. I: The process of care.

OBJECTIVE: To compare the process of out of hours care provided by general practitioners from patients' own practices and by commercial deputising services. DESIGN: Randomised controlled trial. SETTING: Four urban areas in Manchester, Salford, Stockport, and Leicester. SUBJECTS: 2152 patients who requested out of hours care, and 49 practice doctors and 183 deputising doctors (61% local principals) who responded to those requests. MAIN OUTCOME MEASURES: Response to call, time to visit, prescribing, and hospital admissions. RESULTS: 1046 calls were dealt with by practice doctors and 1106 by deputising doctors. Practice doctors were more likely to give telephone advice (20.2% v 0.72% of calls) and to visit more quickly than deputising doctors (median delay 35 minutes v 52 minutes). Practice doctors were less likely than deputising doctors to issue a prescription (56.1% v 63.2% of patients) or to prescribe an antibiotic (43.7% v 61.3% of prescriptions issued) and more likely to prescribe genetic drugs (58.4% v 32.1% of drugs prescribed), cheaper drugs (mean cost per prescription pounds 3.28 v pounds 5.04), and drugs in a predefined out of hours formulary (49.8% v 41.1% of drugs prescribed). There was no significant difference in the number of hospital admissions. CONCLUSIONS: By contrast with practice doctors, deputising doctors providing out of hours care less readily give telephone advice, take longer to visit at home, and have patterns of prescribing that may be less discriminating.

Appointments and Schedules↗

PubMed1997

Comparison of out of hours care provided by patients' own general practitioners and commercial deputising services: a randomised controlled trial. II: The outcome of care.

OBJECTIVE: To compare the outcome of out of hours care given by general practitioners from patients' own practices and by commercial deputising services. DESIGN: Randomised controlled trial. SETTING: Four urban areas in Manchester, Salford, Stockport, and Leicester. SUBJECTS: 2152 patients who requested out of hours care, and 49 practice doctors and 183 deputising doctors (61% local principals in general practice) who responded to the requests. MAIN OUTCOME MEASURES: Health status outcome, patient satisfaction, and subsequent health service use. RESULTS: Patients seen by deputising doctors were less satisfied with the care they received. The mean overall satisfaction score for practice doctors was 70.7 (95% confidence interval 68.1 to 73.2) and for deputising doctors 61.8 (59.9 to 63.7). The greatest difference in satisfaction was with the delay in visiting. There were no differences in the change in health or overall health status measured 24 to 120 hours after the out of hours call or subsequent use of the health service in the two groups. CONCLUSIONS: Patients are more satisfied with the out of hours care provided by practice doctors than that provided by deputising doctors. Organisation of doctors into large groups may produce lower levels of patient satisfaction, especially when associated with increased delays in the time taken to visit. There seem to be no appreciable differences in health outcome between the two types of service.

Appointments and Schedules↗

PubMed1998

Uptake and acceptability of antenatal HIV testing: randomised controlled trial of different methods of offering the test.

OBJECTIVE: To determine the uptake and acceptability of different methods of a universal offer of voluntary HIV testing to pregnant women. DESIGN: Randomised controlled trial involving four combinations of written and verbal communication, followed by the direct offer of a test. The control group received no information and no direct offer of a test, although testing was available on request. SETTING: Hospital antenatal clinic covering most of the population of the city of Edinburgh. SUBJECTS: 3024 pregnant women booking at the clinic over a 10 month period. MAIN OUTCOME MEASURES: Uptake of HIV testing and women's knowledge, satisfaction, and anxiety. RESULTS: Uptake rates were 6% for those in the control group and 35% for those directly offered the test. Neither the style of leaflet nor the length of discussion had an effect on uptake. Significant independent predictors of uptake were a direct test offer; the midwife seen; and being unmarried, previously tested, and younger age. Knowledge of the specific benefits of testing increased with the amount of information given, but neither satisfaction nor anxiety was affected by the type of offer. CONCLUSIONS: The universal offer of HIV testing is not intrusive and is acceptable to pregnant women. A policy of offering the HIV test to all women resulted in higher uptake and did not increase anxiety or dissatisfaction. Uptake depends more on the midwife than the method of offering the test. Low uptake rates and inadequate detection of HIV infection point to the need to assess a more routine approach to testing.

Adult↗

PubMed1999

Effect of preoperative abstinence on poor postoperative outcome in alcohol misusers: randomised controlled trial.

OBJECTIVE: To evaluate the influence of preoperative abstinence on postoperative outcome in alcohol misusers with no symptoms who were drinking the equivalent of at least 60 g ethanol/day. DESIGN: Randomised controlled trial. SETTING: Copenhagen, Denmark. SUBJECTS: 42 alcoholic patients without liver disease admitted for elective colorectal surgery. INTERVENTIONS: Withdrawal from alcohol consumption for 1 month before operation (disulfiram controlled) compared with continuous drinking. MAIN OUTCOME MEASURES: Postoperative complications requiring treatment within the first month after surgery. Perioperative immunosuppression measured by delayed type hypersensitivity; myocardial ischaemia and arrhythmias measured by Holter tape recording; episodes of hypoxaemia measured by pulse oximetry. Response to stress during the operation were assessed by heart rate, blood pressure, serum concentration of cortisol, and plasma concentrations of glucose, interleukin 6, and catecholamines. RESULTS: The intervention group developed significantly fewer postoperative complications than the continuous drinkers (31% v 74%, P=0.02). Delayed type hypersensitivity responses were better in the intervention group before (37 mm2 v 12 mm2, P=0.04), but not after surgery (3 mm2 v 3 mm2). Development of postoperative myocardial ischaemia (23% v 85%) and arrhythmias (33% v 86%) on the second postoperative day as well as nightly hypoxaemic episodes (4 v 18 on the second postoperative night) occurred significantly less often in the intervention group. Surgical stress responses were lower in the intervention group (P</=0.05). CONCLUSIONS: One month of preoperative abstinence reduces postoperative morbidity in alcohol abusers. The mechanism is probably reduced preclinical organ dysfunction and reduction of the exaggerated response to surgical stress.

Adult↗

PubMed2001

Randomised controlled trial of primary school based intervention to reduce risk factors for obesity.

OBJECTIVE: To assess if a school based intervention was effective in reducing risk factors for obesity. DESIGN: Group randomised controlled trial. SETTING: 10 primary schools in Leeds. PARTICIPANTS: 634 children aged 7-11 years. INTERVENTION: Teacher training, modification of school meals, and the development of school action plans targeting the curriculum, physical education, tuck shops, and playground activities. MAIN OUTCOME MEASURES: Body mass index, diet, physical activity, and psychological state. RESULTS: Vegetable consumption by 24 hour recall was higher in children in the intervention group than the control group (weighted mean difference 0.3 portions/day, 95% confidence interval 0.2 to 0.4), representing a difference equivalent to 50% of baseline consumption. Fruit consumption was lower in obese children in the intervention group (-1.0, -1.8 to -0.2) than those in the control group. The three day diary showed higher consumption of high sugar foods (0.8, 0.1 to 1.6)) among overweight children in the intervention group than the control group. Sedentary behaviour was higher in overweight children in the intervention group (0.3, 0.0 to 0.7). Global self worth was higher in obese children in the intervention group (0.3, 0.3 to 0.6). There was no difference in body mass index, other psychological measures, or dieting behaviour between the groups. Focus groups indicated higher levels of self reported behaviour change, understanding, and knowledge among children who had received the intervention. CONCLUSION: Although it was successful in producing changes at school level, the programme had little effect on children's behaviour other than a modest increase in consumption of vegetables.

Body Mass Index↗

PubMed2002

Incidence of fires and related injuries after giving out free smoke alarms: cluster randomised controlled trial.

OBJECTIVE: To measure the effect of giving out free smoke alarms on rates of fires and rates of fire related injury in a deprived multiethnic urban population. DESIGN: Cluster randomised controlled trial. SETTING: Forty electoral wards in two boroughs of inner London, United Kingdom. PARTICIPANTS: Primarily households including elderly people or children and households that are in housing rented from the borough council. INTERVENTION: 20 050 smoke alarms, fittings, and educational brochures distributed free and installed on request. MAIN OUTCOME MEASURES: Rates of fires and related injuries during two years after the distribution; alarm ownership, installation, and function. RESULTS: Giving out free smoke alarms did not reduce injuries related to fire (rate ratio 1.3; 95% confidence interval 0.9 to 1.9), admissions to hospital and deaths (1.3; 0.7 to 2.3), or fires attended by the fire brigade (1.1; 0.96 to 1.3). Similar proportions of intervention and control households had installed alarms (36/119 (30%) v 35/109 (32%); odds ratio 0.9; 95% confidence interval 0.5 to 1.7) and working alarms (19/118 (16%) v 18/108 (17%); 0.9; 0.4 to 1.8). CONCLUSIONS: Giving out free smoke alarms in a deprived, multiethnic, urban community did not reduce injuries related to fire, mostly because few alarms had been installed or were maintained.

Burns↗

PubMed2004

Providing child safety equipment to prevent injuries: randomised controlled trial.

OBJECTIVE: To assess the effectiveness of safety advice and safety equipment in reducing unintentional injuries for families with children aged under 5 years and living in deprived areas. DESIGN: Randomised controlled trial. SETTING: 47 general practices in Nottingham. PARTICIPANTS: 3428 families with children under 5. INTERVENTION: A standardised safety consultation and provision of free and fitted stair gates, fire guards, smoke alarms, cupboard locks, and window locks. MAIN OUTCOME MEASURES: Primary outcome measures were whether a child in the family had at least one injury that required medical attendance and rates of attendance in primary and secondary care and of hospital admission for injury over a two year period. Secondary outcome measures included possession of safety equipment and safety practices. RESULTS: No significant difference was found in the proportion of families in which a child had a medically attended injury (odds ratio 1.14, 95% confidence interval 0.98 to 1.50) or in the rates of attendance in secondary care (incidence rate ratio 1.02, 0.90 to 1.13) or admission to hospital (1.02, 0.70 to 1.48). However, children in the intervention arm had a significantly higher attendance rate for injuries in primary care (1.37, 1.11 to 1.70, P = 0.003). At both one and two years' follow up, families in the intervention arm were significantly more likely to have a range of safety practices, but absolute differences in the percentages were relatively small. CONCLUSIONS: The intervention resulted in significant improvements in safety practices for up to two years but did not reduce injuries that necessitated medical attendance. Although equipment was provided and fitted free of charge, the observed changes in safety practices may not have been large enough to affect injury rates.

Accident Prevention↗

PubMed2006

Community based occupational therapy for patients with dementia and their care givers: randomised controlled trial.

OBJECTIVE: To determine the effectiveness of community based occupational therapy on daily functioning of patients with dementia and the sense of competence of their care givers. DESIGN: Single blind randomised controlled trial. Assessors were blinded for treatment allocation. SETTING: Memory clinic and day clinic of a geriatrics department and participants' homes. PARTICIPANTS: 135 patients aged > or =65 with mild to moderate dementia living in the community and their primary care givers. INTERVENTIONS: 10 sessions of occupational therapy over five weeks, including cognitive and behavioural interventions, to train patients in the use of aids to compensate for cognitive decline and care givers in coping behaviours and supervision. MAIN OUTCOME MEASURES: Patients' daily functioning assessed with the assessment of motor and process skills (AMPS) and the performance scale of the interview of deterioration in daily activities in dementia (IDDD). Care giver burden assessed with the sense of competence questionnaire (SCQ). Participants were evaluated at baseline, six weeks, and three months. RESULTS: Scores improved significantly relative to baseline in patients and care givers in the intervention group compared with the controls (differences were 1.5 (95% confidence interval 1.3 to 1.7) for the process scale; -11.7 (-13.6 to -9.7) for the performance scale; and (11.0; 9.2 to 12.8) for the competence scale). This improvement was still significant at three months. The number needed to treat to reach a clinically relevant improvement in motor and process skills score was 1.3 (1.2 to 1.4) at six weeks. Effect sizes were 2.5, 2.3, and 1.2, respectively, at six weeks and 2.7, 2.4, and 0.8, respectively, at 12 weeks. CONCLUSIONS: Occupational therapy improved patients' daily functioning and reduced the burden on the care giver, despite the patients' limited learning ability. Effects were still present at 12 weeks, which justifies implementation of this intervention. TRIAL REGISTRATION: Clinical Trials NCT00295152 [ClinicalTrials.gov].

Activities of Daily Living↗

PubMed2002

Can lay-led walking programmes increase physical activity in middle aged adults? A randomised controlled trial.

STUDY OBJECTIVE: To compare health walks, a community based lay-led walking scheme versus advice only on physical activity and cardiovascular health status in middle aged adults. DESIGN: Randomised controlled trial with one year follow up. Physical activity was measured by questionnaire. Other measures included attitudes to exercise, body mass index, cholesterol, aerobic capacity, and blood pressure. SETTING: Primary care and community. PARTICIPANTS: 260 men and women aged 40-70 years, taking less than 120 minutes of moderate intensity activity per week. MAIN RESULTS: Seventy three per cent of people completed the trial. Of these, the proportion increasing their activity above 120 minutes of moderate intensity activity per week was 22.6% in the advice only and 35.7% in the health walks group at 12 months (between group difference =13% (95% CI 0.003% to 25.9%) p=0.05). Intention to treat analysis, using the last known value for missing cases, demonstrated smaller differences between the groups (between group difference =6% (95% CI -5% to 16.4%)) with the trend in favour of health walks. There were improvements in the total time spent and number of occasions of moderate intensity activity, and aerobic capacity, but no statistically significant differences between the groups. Other cardiovascular risk factors remained unchanged. CONCLUSIONS: There were no significant between group differences in self reported physical activity at 12 month follow up when the analysis was by intention to treat. In people who completed the trial, health walks was more effective than giving advice only in increasing moderate intensity activity above 120 minutes per week.

Adult↗

PubMed1998

Training pharmacists and pharmacy assistants in the stage-of-change model of smoking cessation: a randomised controlled trial in Scotland.

OBJECTIVE: To evaluate a training workshop for community pharmacy personnel to improve their counselling in smoking cessation based on the stage-of-change model. DESIGN: A randomised controlled trial of community pharmacies and pharmacy customers. SETTING: All 76 non-city community pharmacies registered in Grampian, Scotland, were invited to participate. Sixty-two pharmacies (82%) were recruited. SUBJECTS: All the intervention pharmacy personnel were invited to attend the training; 40 pharmacists and 54 assistants attended. A total of 492 customers who smoked (224 intervention, 268 controls) were recruited during the 12-month recruitment period (overall recruitment rate 63%). MAIN OUTCOME MEASURES: The perceptions of customers and pharmacy personnel of the pharmacy support and self-reported smoking cessation rates for the two groups of customers at one, four, and nine months. RESULTS: The intervention customer respondents were significantly more likely to have discussed stopping smoking with pharmacy personnel, 85% (113) compared with 62% (99) of the controls (p < 0.001). The former also rated their discussion more highly; 34% (45) of the intervention customers compared with 16% (25) of the controls rated it as "very useful" (p = 0.048). Assuming non-responders had lapsed, one-month point prevalence of abstinence was claimed by 30% of intervention customers and 24% of controls (p = 0.12); four months' continuous abstinence was claimed by 16% of intervention customers and 11% of controls (p = 0.094); and nine months' continuous abstinence was claimed by 12% of intervention customers and 7% of controls (p = 0.089). These trends in outcome were not affected by potential confounders (sex, age, socioeconomic status, nicotine dependence, and type of nicotine replacement product used) or adjustment for clustering. CONCLUSIONS: The intervention was associated with increased and more highly rated counselling, and a trend toward higher smoking cessation rates, indicating that community pharmacy personnel have the potential to make a significant contribution to national smoking cessation targets.

Adolescent↗

PubMed2003

Screening for liver cancer: results of a randomised controlled trial in Qidong, China.

OBJECTIVES: To investigate the effectiveness of screening for liver cancer in reducing mortality from the disease in a high-risk population in China. SETTING: A randomised controlled trial was carried out among men aged 30-69 who were chronic carriers of hepatitis-B virus (HBsAg positive) during the period 1989-1995 in Qidong county, Jiangsu Province, China. METHODS: 5581 HBsAg carriers were identified by population screening and randomly assigned to a screening group (group A, 3712 men), and controls (group B, 1869 men). Screening was planned to be six monthly alpha-fetoprotein (AFP) assays, with follow-up of subjects having an abnormal (>/=20 micrograms/l) test. All subjects were followed up for liver cancer and/or death until 31 December 1995. RESULTS: The overall sensitivity and specificity of the programme was 55.3% and 86.5%, respectively; in subjects who complied with all scheduled screening tests, the values were 80.0% and 80.9%. Three hundred and seventy-four primary liver cancer (PLC) cases were diagnosed. The percentage of cases in stage I was significantly higher in group A (29.6%) than in group B (6.0%). The one-, three-, and five-year relative survival rates were 23.7%, 7.0%, and 4.0% in group A, and 9.7%, 4.0%, and 4.1% in group B respectively, with no difference in five-year survival between the groups. The mortality rate in the screened group (1138 per 100,000 person-years) was not significantly different from that in the controls (1114 per 100,000). A Poisson regression model showed that the probability of death (rate ratio) in the screening group was 0.83 (95% CI 0.68-1.03) relative to the control group. CONCLUSIONS: Screening with AFP resulted in earlier diagnosis of liver cancer, but the gain in lead time did not result in any overall reduction in mortality, because therapy for the patients found by screening was ineffective. Further studies using improved methods of screening, diagnosis and treatment are indicated.

Adult↗

PubMed2003

Prospective randomised controlled trial comparing laparoscopic and open colposuspension.

OBJECTIVE: To compare the efficacy, safety, complications, and short-term outcome of laparoscopic and open colposuspension in women with genuine stress incontinence. DESIGN: Randomised controlled trial. SETTING: Urogynaecology unit in a public hospital, Hong Kong. SUBJECTS AND METHODS: Ninety patients with urodynamically proven genuine stress incontinence. Forty-three patients were randomly allocated to receive open colposuspension and 47 to undergo laparoscopy. All patients had reassessment within 1 year of the operation. MAIN OUTCOME MEASURES: Objective and subjective measures and complication rates. RESULTS: There was no significant difference in the duration of stress incontinence, mean preoperative pad test results, or proportion with pre-existing detrusor instability. Among patients in the laparoscopic group, the mean operating time was significantly longer (42.0 minutes versus 29.3 minutes; P<0.0001), while the mean blood loss was significantly less (124.7 mL versus 326.9 mL; P=0.001). Subjective and objective success rates within 1 year were similar for patients in the open and laparoscopic groups (86.0% versus 80.9%; P=0.58, and 86.0% versus 85.1%; P=1.00, respectively). There was no significant difference in the rate of complications, including de novo detrusor instability and an obstructive voiding pattern, enterocele, or dyspareunia. CONCLUSION: Laparoscopic colposuspension is a feasible alternative to the open approach. The operating time is longer but the short-term cure rate is comparable with that of the open approach.

Female↗

PubMed1997

Randomised controlled trial to evaluate early discharge scheme for patients with stroke.

OBJECTIVE: To assess the clinical effectiveness of an early discharge policy for patients with stroke by using a community based rehabilitation team. DESIGN: Randomised controlled trial to compare conventional care with an early discharge policy. SETTING: Two teaching hospitals in inner London. SUBJECTS: 331 medically stable patients with stroke (mean age 71) who lived alone and were able to transfer independently or who lived with a resident carer and were able to transfer with help. INTERVENTIONS: 167 patients received specialist community rehabilitation for up to 3 months after randomisation. 164 patients continued with conventional hospital and community care. MAIN OUTCOME MEASURES: Barthel score at 12 months. Secondary outcomes measured impairment with motoricity index, minimental state examination, and Frenchay aphasia screening test; disability with the Rivermead activity of daily living scales, hospital anxiety and depression scale, and 5 m walk; handicap with the Nottingham health profile; carer stress with caregiver strain index and patient and carer satisfaction. The main process measure was length of stay after randomisation. RESULTS: One year after randomisation no significant differences in clinical outcomes were found apart from increased satisfaction with hospital care in the community therapy group. Length of stay after randomisation in the community therapy group was significantly reduced (12 v 18 days; P < 0.0001). Patients with impairments were more likely to receive treatment in the community therapy group. CONCLUSIONS: Early discharge with specialist community rehabilitation after stroke is feasible, as clinically effective as conventional care, and acceptable to patients. Considerable reductions in use of hospital beds are achievable.

Activities of Daily Living↗

PubMed2006

Double masked randomised controlled trial to assess the effectiveness of paracetamol in reducing pain in panretinal photocoagulation.

AIM: To assess the effectiveness of pre-emptive analgesia with paracetamol in reducing pain associated with panretinal photocoagulation (PRP) in a prospective, double masked, randomised controlled trial. METHOD: 60 patients undergoing PRP for the first time were enrolled and randomised to paracetamol or placebo, taken for 2 days starting 24 hours before the laser treatment. The laser treatment was performed following a standardised protocol. Pain during and after treatment was assessed using the McGill pain questionnaire (MPQ) and visual analogue scales (VAS). RESULTS: The statistical analysis looked for differences between the two study groups immediately after the laser surgery and 24 hours later. There was no statistically significant difference in the primary outcome measure of perception of pain during and 24 hours after PRP, between the paracetamol and placebo group. However, none of the patients in the paracetamol group reported increased total pain at 24 hours, whereas six patients in the placebo group reported increased pain; this difference (21%) was significant to p = 0.01. CONCLUSIONS: Pre-emptive analgesia with paracetamol did not significantly reduce pain associated with PRP. This study has described for the first time the type of pain associated with PRP, which is perceived mainly as a discomfort. The main attributes of the pain that patients described, were sharp, flashing, tiring, intense, piercing, intermittent, and brief.

Acetaminophen↗