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Results for “Randomised Controlled Trial”

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PubMed1998

Sweeping of the membranes at 39 weeks in nulliparous women: a randomised controlled trial.

OBJECTIVE: To determine whether weekly sweeping of the membranes from 39 weeks of gestation results in a reduction in the number of women reaching 41 completed weeks and subsequently in a reduction of the number of women who will need induction of labour. DESIGN: Randomised controlled trial. PARTICIPANTS: Two hundred and seventy-eight nulliparous women, who were seen at the antenatal clinic of a university teaching hospital, were randomly allocated at 39 weeks of gestation to receive on a weekly basis either sweeping of the membranes (n = 140) or a routine pelvic examination (n = 138). MAIN OUTCOME MEASURES: The time interval between randomisation and delivery, the incidence of prolonged pregnancy (i.e. > 41 completed weeks), and the incidence of induction of labour. RESULTS: In 24 women (17%) sweeping of the membranes was not possible. Fifty-three women (38%) in the sweeping group and 50 women (36%) in the control group were delivered within one week after randomisation. Women allocated to sweeping showed a trend towards having a shorter randomisation-delivery interval: 9.4 days versus 10.6 days in the controls (P = 0.087). Sweeping had no statistically significant effect on the mean duration of pregnancy (282.8 days in the sweeping group versus 283.8 days in the control group, P = 0.127). The need for induction of labour was significantly reduced in those women who underwent sweeping (11% versus 26%, P = 0.004), merely as a result of a decrease in the number of women that exceeded 41 weeks (19% versus 33%, P = 0.016). CONCLUSION: Sweeping of the membranes weekly from 39 weeks does not increase the number of women who will deliver within the first week but significantly decreases the number that will reach 41 weeks. Induction of labour then becomes less necessary.

Extraembryonic Membranes↗

PubMed2005

A randomised controlled trial in the north of England examining the effects of skin-to-skin care on breast feeding.

OBJECTIVE: to examine the effect of early skin-to-skin contact between mothers and their healthy full-term babies on initiation and duration of breast feeding. DESIGN: a randomised controlled trial comparing skin-to-skin with routine care. SETTING: Warrington Hospital, Cheshire, UK. PARTICIPANTS: 204 mother and baby pairs; 102 randomised to each group. OUTCOME MEASURES: success of first breast feed, maternal satisfaction with skin-to-skin care and preference for future post-delivery care, baby-body temperature 1 hr after birth, partial or exclusive breast feeding at 4 months. FINDINGS: in the skin-to-skin group, 89 out of 98 (91%) babies had a successful first feed compared with 82 out of 89 (83%) in the routine care group. The difference in the success rate was 8%, 95% confidence interval (CI) (-1.6%, 17.6%); chi(2)=2.7; df=1; P=0.10. Forty-two out of 97 (43%) babies given skin-to-skin were partially or exclusively breast feeding at 4 months compared with 40 out of 100 (40%) of babies in the routine care group. The difference in breast-feeding rate at 4 months was 3.3%, 95% CI (-10.3%, 16.7% ); chi(2)=0.22; df=1; P=0.64. The mean temperature 1 hr after birth was higher with skin-to-skin than routine care. The difference in means was 0.15 degrees C; 95% CI (0.03, 0.28); P=0.02. A larger proportion of mothers (87/97 [90%]) were very satisfied with skin-to-skin care, compared with 60 out of 102 (59%) in the control group; 83 out of 97 (86%) of the mothers in the intervention group said that they would prefer to receive the same care in the future compared with 31 out of 102 (30%) mothers in the control group. CONCLUSIONS: the difference between the groups in the success rate for the first breast feed and rates at 4 months was not statistically significant. However, mothers who had skin-to-skin contact enjoyed the experience, and most reported that they would choose to have skin-to skin care in the future. In this, the largest trial to date, previous concerns about baby-body temperature after skin-to-skin care were dispelled.

Adult↗

PubMed2004

Occupational therapy compared with social work assessment for older people. An economic evaluation alongside the CAMELOT randomised controlled trial.

OBJECTIVES: To compare costs and outcome of occupational therapy-led assessment with social worker-led assessment of older people, in terms of their independence and quality of life. DESIGN: Cost-effectiveness analysis alongside a randomised controlled trial. The analysis took viewpoints of health services and patients. The primary outcome measure for cost-effectiveness was dependency using the Community Dependency Index (CDI). Secondary outcomes included utility scores based on the EuroQoL (EQ-5D). Resource use was measured for each patient, from clinical records and from patient carer interviews at 8 months. Unit costs of health and social care resources were derived from local sources and national datasets. Cost-effectiveness was analysed using cost-effectiveness acceptability curves. RESULTS: There were no differences between the two arms of the trial in terms of cost-effectiveness. There is an apparent increase in mean cost per case for the occupational therapy arm but this is not statistically significant (mean difference in cost per case 542 pounds, 95% CI 434-1,519 pounds). Mean total costs of care per participant were 4,379 pounds and 3,837 pounds for the occupational therapy and social work arms, respectively. At best the intervention would improve outcomes at a cost of 14,000 pounds per quality-adjusted life year (QALY). The probability of such an outcome was <50%. CONCLUSIONS: From a policy perspective, the lack of difference in clinical and cost-effectiveness means that either a social work or an occupational therapy service is successful in making care assessments that enable an older person to remain in their own home.

Aged↗

PubMed1990

Randomised controlled trial of day patient versus inpatient psychiatric treatment.

OBJECTIVE: To assess the proportion of acutely ill psychiatric patients who can be treated in a day hospital and compare the outcome of day patient and inpatient treatment. DESIGN: Prospective randomised controlled trial of day patient versus inpatient treatment after exclusion of patients precluded by severity of illness or other factors from being treated as day patients. All three groups assessed at three and 12 months. SETTING: Teaching hospital serving small socially deprived inner city area. Day hospital designed to take acute admissions because of few beds. PATIENTS: 175 Patients were considered, of whom 73 could not be allocated. Of the remaining 102 patients, 51 were allocated to each treatment setting but only 89 became established in treatment--namely, 41 day patients and 48 inpatients. 73 Of these 89 patients were reassessed at three months and 70 at one year. INTERVENTIONS: Standard day patient and inpatient treatment. MAIN OUTCOME MEASURES: Discharge from hospital and return to previous level of social functioning; reduction of psychiatric symptoms, abnormal behaviour, and burden on relatives. RESULTS: 33 Of 48 inpatients were discharged at three months compared with 17 of 41 day patients. But at one year 9 of 48 inpatients and three of 41 day patients were in hospital. 18 Of 35 day patients and 16 of 39 inpatients were at their previous level of social functioning at one year. The only significant difference at three months was a greater improvement in social role performance in the inpatients. At one year there was no significant difference between day patients and inpatients in present state examination summary scores and social role performance, burden, or behaviour. CONCLUSIONS: Roughly 40% of all acutely ill patients presenting for admission to a psychiatric unit may be treated satisfactorily in a well staffed day hospital. The outcome of treatment is similar to that of inpatient care but might possibly reduce readmissions. The hospital costs seem to be similar but further research is required to assess the costs in terms of extra demands on relatives, general practitioners, and other community resources.

Acute Disease↗

PubMed1991

Randomised controlled trial comparing oral and intravenous rehydration therapy in children with diarrhoea.

OBJECTIVE: To determine the effectiveness of oral rehydration in children with moderate dehydration caused by gastroenteritis, and to compare the complications of oral and intravenous treatment. DESIGN: Randomised controlled trial. SETTING: Emergency department and infectious diseases ward in a large urban teaching hospital. PATIENTS: 111 children aged 3-36 months who had been previously healthy, had had diarrhoea for seven days or less, had clinical signs of dehydration, and were not in shock. Six children were withdrawn because the diagnosis was incorrect (four in oral group, two in intravenous group) and one (oral group) was withdrawn at her parents' request. INTERVENTIONS: Oral rehydration fluid was given by mouth or nasogastric tube, or both to 52 children. The remaining 52 received intravenous rehydration fluids but were allowed to drink. MAIN OUTCOME MEASURES: Success or failure of rehydration. Number of times child vomited or passed stool after starting treatment. Time taken to rehydrate. RESULTS: Oral treatment failed in two children (failure rate 3.8%, upper 95% confidence limit 11.6%) and intravenous treatment in none. Vomiting was more common in the oral group (p less than 0.01): 26 of 50 children (52%) in the oral group and 11 of 50 (22%) in the intravenous group vomited during rehydration. There was no significant difference between the two treatment groups in the number of stools passed during rehydration (p = 0.09). None of the children had serious complications of treatment. CONCLUSION: Rehydration by mouth or nasogastric tube is a safe and effective treatment for moderately dehydrated children with gastroenteritis.

Administration, Oral↗

PubMed2000

Randomised controlled trial comparing effectiveness of touch screen system with leaflet for providing women with information on prenatal tests.

OBJECTIVE: To compare the effectiveness of touch screen system with information leaflet for providing women with information on prenatal tests. DESIGN: Randomised controlled trial; participants allocated to intervention group (given access to touch screen and leaflet information) or control group (leaflet information only). SETTING: Antenatal clinic in university teaching hospital. SUBJECTS: 875 women booking antenatal care. INTERVENTIONS: All participants received a leaflet providing information on prenatal tests. Women in the intervention arm also had access to touch screen information system in antenatal clinic. MAIN OUTCOME MEASURES: Women's informed decision making on prenatal testing as measured by their uptake of and understanding of the purpose of specific tests; their satisfaction with information provided; and their levels of anxiety. RESULTS: All women in the trial had a good baseline knowledge of prenatal tests. Women in the intervention group did not show any greater understanding of the purpose of the tests than control women. However, uptake of detailed anomaly scans was significantly higher in intervention group than the control group (94% (351/375) v 87% (310/358), P=0.0014). Levels of anxiety among nulliparous women in intervention group declined significantly over time (P<0.001). CONCLUSIONS: The touch screen seemed to convey no benefit over well prepared leaflets in improving understanding of prenatal tests among the pregnant women. It did, however, seem to reduce levels of anxiety and may be most effective for providing information to selected women who have a relevant adverse history or abnormal results from tests in their current pregnancy.

Attitude to Health↗

PubMed2004

Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery.

OBJECTIVE: To evaluate whether a screening strategy in pregnancy lowers the rate of preterm delivery in a general population of pregnant women. DESIGN: Multicentre, prospective, randomised controlled trial. SETTING: Non-hospital based antenatal clinics. PARTICIPANTS: 4429 pregnant women presenting for their routine prenatal visits early in the second trimester were screened by Gram stain for asymptomatic vaginal infection. In the intervention group, the women's obstetricians received the test results and women received standard treatment and follow up for any detected infection. In the control group, the results of the vaginal smears were not revealed to the caregivers. MAIN OUTCOME MEASURES: The primary outcome variable was preterm delivery at less than 37 weeks. Secondary outcome variables were preterm delivery at less than 37 weeks combined with different birth weight categories equal to or below 2500 g and the rate of late miscarriage. RESULTS: Outcome data were available for 2058 women in the intervention group and 2097 women in the control group. In the intervention group, the number of preterm births was significantly lower than in the control group (3.0% v 5.3%, 95% confidence interval 1.2 to 3.6; P = 0.0001). Preterm births were also significantly reduced in lower weight categories at less than 37 weeks and <or= 2500 g. Eight late miscarriages occurred in the intervention group and 15 in the control group. CONCLUSION: Integrating a simple infection screening programme into routine antenatal care leads to a significant reduction in preterm births and reduces the rate of late miscarriage in a general population of pregnant women.

Adult↗

PubMed2005

Household based treatment of drinking water with flocculant-disinfectant for preventing diarrhoea in areas with turbid source water in rural western Kenya: cluster randomised controlled trial.

OBJECTIVE: To compare the effect on prevalence of diarrhoea and mortality of household based treatment of drinking water with flocculant-disinfectant, sodium hypochlorite, and standard practices in areas with turbid water source in Africa. DESIGN: Cluster randomised controlled trial over 20 weeks. SETTING: Family compounds, each containing several houses, in rural western Kenya. PARTICIPANTS: 6650 people in 605 family compounds. INTERVENTION: Water treatment: flocculant-disinfectant, sodium hypochlorite, and usual practice (control). MAIN OUTCOME MEASURES: Prevalence of diarrhoea and all cause mortality. Escherichia coli concentration, free residual chlorine concentration, and turbidity in household drinking water as surrogates for effectiveness of water treatment. RESULTS: In children < 2 years old, compared with those in the control compounds, the absolute difference in prevalence of diarrhoea was -25% in the flocculant-disinfectant arm (95% confidence interval -40 to -5) and -17% in the sodium hypochlorite arm (-34 to 4). In all age groups compared with control, the absolute difference in prevalence was -19% in the flocculant-disinfectant arm (-34 to -2) and -26% in the sodium hypochlorite arm (-39 to -9). There were significantly fewer deaths in the intervention compounds than in the control compounds (relative risk of death 0.58, P = 0.036). Fourteen per cent of water samples from control compounds had E coli concentrations < 1 CFU/100 ml compared with 82% in flocculant-disinfectant and 78% in sodium hypochlorite compounds. The mean turbidity of drinking water was 8 nephelometric turbidity units (NTU) in flocculant-disinfectant households, compared with 55 NTU in the two other compounds (P < 0.001). CONCLUSIONS: In areas of turbid water, flocculant-disinfectant was associated with a significant reduction in diarrhoea among children < 2 years. This health benefit, combined with a significant reduction in turbidity, suggests that the flocculant-disinfectant is well suited to areas with highly contaminated and turbid water.

Adolescent↗

PubMed1992

Respiratory effects of lowering tar and nicotine levels of cigarettes smoked by young male middle tar smokers. I. Design of a randomised controlled trial.

STUDY OBJECTIVE: The aim was to investigate the effect on respiratory health of male middle tar smokers changing the tar and nicotine levels of the cigarettes they smoke for a six month period. DESIGN: This was a randomised controlled trial. Middle tar smokers were randomly allocated to smoke one of three different types of cigarette (low tar, middle nicotine; middle tar, middle nicotine; and low tar, low nicotine) in place of their usual cigarette for a six month period. Main outcome measures were assessment of respiratory health by documenting respiratory symptoms and peak expiratory flow rates, and of nicotine inhalation by measuring the urinary excretion of nicotine metabolites. SETTING: 21 local authority districts of England. SUBJECTS: Participants were male middle tar smokers aged 18-44 years. MAIN RESULTS: Postal questionnaires were sent to 265,016 individuals selected from the electoral registers of 21 local authority districts of England; 64% of questionnaires were returned revealing 7736 men aged 18-44 years who smoked only middle tar cigarettes. Of these, 7029 (90%) were sent a health warning and 707 (10%) were not; the latter acted as a control group to assess the effect of the health warning. Of the 7029 men who had received a health warning and were visited at the recruitment stage, 2666 agreed and were eligible to participate in the trial although only 1541 (58% of those who agreed and were eligible) actually started smoking the study cigarettes; 643 men (24% of those willing to participate at the beginning of the trial and 42% of those who actually started smoking the study cigarettes) completed the trial smoking the study cigarettes. Of these, 213 were in the low tar middle nicotine group, 220 were in the middle tar middle nicotine group, and 210 were in the low tar low nicotine group. CONCLUSIONS: This study shows the feasibility of identifying and recruiting sufficient numbers of male middle tar smokers, with adequate numbers completing the trial, to detect any changes in respiratory health over a six month period.

Adolescent↗

PubMed1992

Respiratory effects of lowering tar and nicotine levels of cigarettes smoked by young male middle tar smokers. II. Results of a randomised controlled trial.

STUDY OBJECTIVE: The aim was to investigate the effect on respiratory health of male middle tar smokers changing the tar and nicotine levels of the cigarettes they smoke for a six month period. DESIGN: This was a randomised controlled trial. Middle tar smokers were randomly allocated to smoke one of three different types of cigarette (low tar, middle nicotine; middle tar, middle nicotine; and low tar, low nicotine) in place of their usual cigarette for a six month period. Main outcome measures were assessment of respiratory health by documenting respiratory symptoms and peak expiratory flow rates, and of nicotine inhalation by measuring the urinary excretion of nicotine metabolites. SETTING: 21 local authority districts of England. SUBJECTS: Participants were male middle tar smokers aged 18-44 years. MAIN RESULTS: Changes in the measures of respiratory health showed little difference over the trial period between the three cigarette groups. Analyses of the urinary nicotine metabolites showed that smokers allocated to each of the three study cigarettes adjusted their smoking so that throughout the trial their nicotine inhalation differed little from their pretrial intakes when they were smoking their own cigarettes. As a result of the altered patterns of smoking to compensate for the reduced nicotine yields of the three study cigarettes, the tar intake of those allocated to smoke the middle tar, middle nicotine cigarettes remained essentially unchanged, while those allocated to smoke the low tar, low nicotine and low tar, middle nicotine cigarettes had calculated reductions in tar intakes of about 14% and 18%, respectively. CONCLUSIONS: Due to the phenomenon of compensation, tar intake can only be reduced substantially by using a cigarette with a markedly lower tar/nicotine ratio. Nevertheless reductions of up to about 18% in tar intake failed to result in any detectable effect on respiratory symptoms or peak expiratory flow rates over a six month period.

Adolescent↗

PubMed2004

The Social Support and Family Health Study: a randomised controlled trial and economic evaluation of two alternative forms of postnatal support for mothers living in disadvantaged inner-city areas.

OBJECTIVES: To determine whether increased postnatal support could influence maternal and child health outcomes. DESIGN: This was a randomised controlled trial comparing maternal and child health outcomes for women offered either of the support interventions with those for control women receiving standard services only. Outcome data were collected through questionnaires distributed 12 and 18 months postrandomisation. Process data were also collected. There was also an integral economic evaluation. SETTING AND PARTICIPANTS: Women living in deprived enumeration districts in selected London boroughs were eligible for the trial if they gave birth between 1 January and 30 September 1999. RESULTS: The 731 participants were found to be well matched in terms of socio-economic characteristics and health and support variables (14% of the participants were non-English speaking). Response rates at the two follow-up points were 90% and 82%. At both points there were no differences that could not be attributed to chance on the primary outcomes of maternal depression, child injury or maternal smoking. At the first follow-up, there was reduced use of general practitioners by support health visitor (SHV) children, but increased use of NHS health visitors and social workers by mothers. At the second follow-up, both community group support (CGS) and SHV mothers had less use of midwifery services (fewer were pregnant), and SHV mothers were less worried about their child's health and development. Uptake of the CGS intervention was low: 19%, compared with 94% for the SHV intervention. Satisfaction with the intervention among women in the SHV group was high. Based on the assumptions and conditions of the costing methods, the economic evaluation found no net economic cost or benefit of choosing either of the two interventions. CONCLUSIONS: There was no evidence of impact on the primary outcomes of either intervention. The SHV intervention was popular with women, and was associated with improvement in some of the secondary outcomes. This suggests that greater emphasis on the social support role of health visitors could improve some measures of family well-being. Possible areas for future research include a systematic review of social support and its effect on health; developing and testing other postnatal models of support that match more closely the age of the baby and the changing patterns of mothers' needs; evaluating other strategies for mobilising 'non-professional' support; developing and testing more culturally specific support interventions; developing more culturally appropriate standardised measures of health outcomes; providing longer term follow-up of social support interventions; and exploring the role of social support on the delay in subsequent pregnancy.

Adult↗

PubMed1998

A sequential randomised controlled trial comparing a dry visco-elastic polymer pad and standard operating table mattress in the prevention of post-operative pressure sores.

Four hundred and forty-six general, vascular and gynaecological surgical patients were recruited to a two centre, double triangular sequential randomised controlled trial to compare the post-operative pressure sore incidence in patients positioned on the standard operating table mattress with those positioned on the dry visco-elastic polymer pad (Action Products Inc.). Two hundred and twenty two patients were randomised to the experimental group and 224 to the standard mattress. The main endpoint failure rate (a pressure sore) was found to be 11% (22/205) for patients allocated to the dry visco-elastic polymer pad and 20% (43/211) for patients allocated to the standard operating table mattress. There was a significant reduction in the odds of developing a pressure sore on the dry visco-elastic polymer pad as compared to the standard, [symbol see text] = 0.46 with 95% confidence interval of (0.26, 0.82), P = 0.010. The adjusted point estimates of the probability of developing a pressure sore on the dry visco-elastic polymer pad and the standard operating table mattress were 0.11 and 0.21 respectively.

Aged↗

PubMed1999

Occupational therapy for stroke patients not admitted to hospital: a randomised controlled trial.

BACKGROUND: Patients who have a stroke are not always admitted to hospital, and 22-60% remain in the community, frequently without coordinated rehabilitation. We aimed to assess the efficacy of an occupational therapy intervention for patients with stroke who were not admitted to hospital. METHODS: In this single-blind randomised controlled trial, consecutive stroke patients on a UK community register in Nottingham and Derbyshire were allocated randomly to up to 5 months of occupational therapy at home or to no intervention (control group) 1 month after their stroke. The aim of the occupational therapy was to encourage independence in personal and instrumental activities of daily living. Patients were assessed on outcome measures at baseline (before randomisation) and at 6 months. The primary outcome measure was the score on the extended activities of daily living (EADL) scale at 6 months. Other outcome measures included the Barthel index, the general health questionnaire 28, the carer strain index, and the London handicap scale. All assessments were done by an independent assessor who was unaware of treatment allocation. The analysis included only data from completed questionnaires. FINDINGS: 185 patients were included: 94 in the occupational therapy group and 91 in the control group. 22 patients were not assessed at 6 months. At follow-up, patients who had occupational therapy had significantly higher median scores than the controls on: the EADL scale (16 vs 12, p<0.01, estimated difference 3 [95% CI 1 to 4]); the Barthel index (20 vs 18, p<0.01, difference 1, [0-1]); the carer strain index (1 vs 3, p<0.05, difference 1 [0 to 2]); and the London handicap scale (76 vs 65, p<0.05, difference 7, [0.3 to 13.5]). There were no significant differences on the general health questionnaire between the patient or carer. INTERPRETATION: Occupational therapy significantly reduced disability and handicap in patients with stroke who were not admitted to hospital.

Activities of Daily Living↗

PubMed1998

Randomised controlled trial comparing effectiveness and acceptability of an early discharge, hospital at home scheme with acute hospital care.

OBJECTIVE: To compare effectiveness and acceptability of early discharge to a hospital at home scheme with that of routine discharge from acute hospital. DESIGN: Pragmatic randomised controlled trial. SETTING: Acute hospital wards and community in north of Bristol, with a catchment population of about 224 000 people. SUBJECTS: 241 hospitalised but medically stable elderly patients who fulfilled criteria for early discharge to hospital at home scheme and who consented to participate. INTERVENTIONS: Patients' received hospital at home care or routine hospital care. MAIN OUTCOME MEASURES: Patients' quality of life, satisfaction, and physical functioning assessed at 4 weeks and 3 months after randomisation to treatment; length of stay in hospital and in hospital at home scheme after randomisation; mortality at 3 months. RESULTS: There were no significant differences in patient mortality, quality of life, and physical functioning between the two arms of the trial at 4 weeks or 3 months. Only one of 11 measures of patient satisfaction was significantly different: hospital at home patients perceived higher levels of involvement in decisions. Length of stay for those receiving routine hospital care was 62% (95% confidence interval 51% to 75%) of length of stay in hospital at home scheme. CONCLUSIONS: The early discharge hospital at home scheme was similar to routine hospital discharge in terms of effectiveness and acceptability. Increased length of stay associated with the scheme must be interpreted with caution because of different organisational characteristics of the services.

Activities of Daily Living↗

PubMed2002

A double-blind randomised controlled trial of continuous oxygen therapy for compromised fetuses.

OBJECTIVE: To investigate the effect of chronic oxygen therapy in fetuses with absent end diastolic flow in the umbilical artery assessed by doppler analysis at 24-30 weeks of gestation. DESIGN: A double-blind, randomised control trial was performed with patients blindly allocated to receive humidified oxygen or humidified air. SETTING: A tertiary referral hospital in South Africa. PARTICIPANTS: Thirty-two women who presented between 24 and 30 weeks of gestation with a confirmed finding of absent end diastolic flow in the umbilical artery. METHODS: After randomisation patients were allocated to receive a 40% mixture of humidified oxygen or humidified air from uniform coloured gas cylinders which were marked either 'a' or 'b' All women received betamethasone from 27 weeks of gestation on a weekly basis. Cardiotocographs were used from 28 weeks of gestation; after 28 weeks of gestation an amniocentesis was considered to confirm fetal maturity. Women were expected to breath the allocated gas continuously apart from meals and visits to the toilet. MAIN OUTCOME MEASURES: Survival of the fetus was the main outcome measure with secondary outcome measures documenting improvement in the fetal condition in utero. RESULTS: There were 16 women randomised to receive oxygen and 16 to receive air. There were nine survivors in the oxygen group (56.3%) and six in the air group (37.5%) (relative risk 1.5, 95% confidence interval 0.7-3.2). There was a nonsignificant increase in mean birthweight in the oxygen group (858.3 grammes vs 774.4 grammes) and a nonsignificant increase in mean duration of treatment in the oxygen group (12.8 days vs 10.4 days). CONCLUSION: This study did not demonstrate that chronic oxygen therapy provides any benefits to compromised fetuses between 24 and 30 weeks of gestation. Larger studies with sufficient power are necessary to assess whether oxygen therapy can reduce perinatal mortality by a clinically useful amount in this group of patients.

Cardiotocography↗

PubMed1998

Randomised controlled trial of biofeedback training in persistent encopresis with anismus.

BACKGROUND: Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction. METHODS: A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine whether such training produces sustained faecal continence. Up to four sessions of biofeedback training were conducted at weekly intervals for each patient. Anorectal manometry was performed before randomisation and six months later. Parents of patients completed the "child behaviour checklist" (CBCL) before randomisation and at follow up. RESULTS: Sixty eight children underwent anorectal manometry and EMG. Of these, 29 had anismus (ages 4-14 years) and were randomised to either EMG biofeedback training and conventional medical treatment (BFT) (n = 14) or to conventional medical treatment alone (n = 15). All but one child were able to learn relaxation of the external anal sphincter on attempted defecation. At six months' follow up, laxative free remission had been sustained in two of 14 patients in the BFT group and in two of 15 controls (95% confidence interval (CI) on difference, -24% to 26%). Remission or improvement occurred in four of 14 patients in the BFT group and six of 15 controls (95% CI on difference, -46% to 23%). Of subjects available for repeat anorectal manometry and EMG at six months, six of 13 in the BFT group still demonstrated anismus v 11 of 13 controls (95% CI on difference, -75% to -1%). Of the four patients in full remission at six months, only one (in the BFT group) did not exhibit anismus. Rectal hyposensitivity was not associated with remission or improvement in either of the groups. Mean CBCL total behaviour problem scores were not significantly different between the BFT and control groups, but there was a significant improvement in CBCL school scale scores in the BFT group, and this improvement was significantly greater than that seen in the control group. CONCLUSIONS: The result of this study, together with those reported in other controlled trials, argues against using biofeedback training in children with encopresis.

Adolescent↗

PubMed2006

Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme.

OBJECTIVES: To test the hypothesis that group cognitive behavioural therapy (CBT) will produce an effective and cost-effective management strategy for patients in primary care with chronic fatigue syndrome/myalgic encephalopathy (CFS/ME). DESIGN: A double-blind, randomised controlled trial was adopted with three arms. Outcomes were assessed at baseline and 6 and 12 months after first assessment and results were analysed on an intention-to-treat basis. SETTING: A health psychology department for the management of chronic illness in a general hospital in Bristol, UK. PARTICIPANTS: Adults with a diagnosis of CFS/ME referred by their GP. INTERVENTIONS: The three interventions were group CBT incorporating graded activity scheduling, education and support group (EAS) and standard medical care (SMC). OUTCOME MEASURES: The primary outcome measure was the Short Form with 36 Items (SF-36) physical and mental health summary scales. Other outcome measures included the Chalder fatigue scale, Hospital Anxiety and Depression Scale, General Health Questionnaire, physical function (shuttles walked, walking speed and perceived fatigue), health utilities index and cognitive function (mood, recall and reaction times). RESULTS: A total of 153 patients were recruited to the trial and 52 were randomised to receive CBT, 50 to EAS and 51 to SMC. Twelve patients failed to attend for the 12-month follow-up and 19 patients attended one follow-up, but not both. The sample was found to be representative of the patient group and the characteristics of the three groups were similar at baseline. Three outcome measures, SF-36 mental health score, Chalder fatigue scale and walking speed, showed statistically significant differences between the groups. Patients in the CBT group had significantly higher mental health scores [difference +4.35, 95% confidence interval (CI) +0.72 to +7.97, p = 0.019], less fatigue (difference -2.61, 95% CI -4.92 to -0.30, p = 0.027) and were able to walk faster (difference +2.83 shuttles, 95% CI +1.12 to +5.53, p = 0.0013) than patients in the SMC group. CBT patients also walked faster and were less fatigued than those randomised to EAS (walking speed: difference +1.77, 95% CI +0.025 to +3.51, p = 0.047; fatigue: difference -3.16, 95% CI -5.59 to -0.74, p = 0.011). Overall, no other statistically significant difference across the groups was found, although for many measures a trend towards an improved outcome with CBT was seen. Except for walking speed, which, on average, increased by +0.87 shuttles (95% CI +0.09 to +1.65, p = 0.029) between the 6- and 12-month follow-ups, the scores were similar at 6 and 12 months. At baseline, 30% of patients had an SF-36 physical score within the normal range and 52% had an SF-36 mental health score in the normal range. At 12 months, the physical score was in the normal range for 46% of the CBT group, 26% of the EAS group and 44% of SMC patients. For mental health score the percentages were CBT 74%, EAS 67% and SMC 70%. Of the CBT group, 32% showed at least a 15% increase in physical function and 64% achieved a similar improvement in their mental health. For the EAS and SMC groups, this improvement in physical and mental health was achieved for 40 and 60% (EAS) and 49 and 53% (SMC), respectively. The cost-effectiveness of the intervention proved very difficult to assess and did not yield reliable conclusions. CONCLUSIONS: Group CBT did not achieve the expected change in the primary outcome measure as a significant number did not achieve scores within the normal range post-intervention. The treatment did not return a significant number of subjects to within the normal range on this domain; however, significant improvements were evident in some areas. Group CBT was effective in treating symptoms of fatigue, mood and physical fitness in CFS/ME. It was found to be as effective as trials using individual therapy in these domains. However, it did not bring about improvement in cognitive function or quality of life. There was also evidence of improvement in the EAS group, which indicates that there is limited value in the non-specific effects of therapy. Further research is needed to develop better outcome measures, assessments of the broader costs of the illness and a clearer picture of the characteristics best fitted to this type of intervention.

Adult↗

PubMed2004

A randomised, controlled trial of once daily and multi-dose daily gentamicin in young Kenyan infants.

AIMS: To test the suitability of a simple once daily (OD) gentamicin regimen for use in young infants where routine therapeutic drug monitoring is not possible. METHODS: In an open, randomised, controlled trial, infants with suspected severe sepsis admitted to a Kenyan, rural district hospital received a novel, OD gentamicin regimen or routine multi-dose (MD) regimens. RESULTS: A total of 297 infants (over 40% < or =7 days) were randomised per protocol; 292 contributed at least some data for analysis of pharmacological endpoints. One hour after the first dose, 5% (7/136) and 28% (35/123) of infants in OD and MD arms respectively had plasma gentamicin concentrations <4 microg/ml (a surrogate of treatment inadequacy). Geometric mean gentamicin concentrations at this time were 9.0 microg/ml (95% CI 8.3 to 9.9) and 4.7 microg/ml (95% CI 4.2 to 5.3) respectively. By the fourth day, pre-dose concentrations > or =2 microg/ml (a surrogate of potential treatment toxicity) were found in 6% (5/89) and 24% (21/86) of infants respectively. Mortality was similar in both groups and clinically insignificant, although potential gentamicin induced renal toxicity was observed in <2% infants. CONCLUSIONS: A "two, four, six, eight" OD gentamicin regime, appropriate for premature infants and those in the first days and weeks of life, seems a suitable, safe prescribing guide in resource poor settings.

Anti-Bacterial Agents↗