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Results for “Randomised Controlled Trial”

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PubMed2005

Adjuvant prednisone therapy in pharyngitis: a randomised controlled trial from general practice.

BACKGROUND: Acute pharyngitis is a frequent and well-documented complaint in general practice but the associated suffering has remained largely unaddressed in the literature. Evidence, however, from five randomised controlled trials suggests that corticosteroids may be useful in relieving pain and discomfort arising from the condition. AIM: To determine if short-acting oral therapy with prednisone was more effective than placebo in alleviating the suffering from acute pharyngitis in adults in a general practice setting. DESIGN OF STUDY: Randomised placebo-controlled trial. SETTING: General practice in Israel. METHOD: Patients with acute pharyngitis were randomised to receive 60 mg prednisone orally for 1 or 2 days, or identical placebo treatment. The main outcome measures were throat pain, measured by a visual analogue scale at 12, 24, 48 and 72 hours after presentation, time off work, fever, dysphagia, recurrence of symptoms and bacterial recurrence. RESULTS: Patients treated with prednisone experienced more rapid throat pain resolution than those in the placebo group. No adverse effects were reported nor any differences between the two groups regarding either symptom or positive bacterial culture recurrence. CONCLUSION: Short-acting oral steroid therapy is effective for shortening throat pain duration in acute pharyngitis.

Adolescent↗

PubMed2002

Effectiveness of ear syringing in general practice: a randomised controlled trial and patients' experiences.

BACKGROUND: Ear syringing is a common procedure performed for a variety of symptoms in primary care. Reports of its effectiveness vary considerably and no randomised controlled trials (RCTs) have been performed. AIM: To estimate the effect of ear syringing on hearing thresholds and on symptoms leading to ear syringing in general practice. DESIGN OF STUDY: Randomised single-blind controlled trial. Before-and-after self-assessments of symptoms. SETTING: Patients from three general practices in the Bristol area attending twice-weekly clinics dedicated to ear syringing over a 12-week period. METHOD: Patients were randomly assigned to have their hearing tested before and after ear syringing, or twice before ear syringing. Changes in hearing threshold were measured by pure tone audiometry (PTA). All patients completed sef-assessment forms of symptoms using Likert scales before, and one week after, ear syringing. RESULTS: Hearing threshold improved by 10 dB or more in 34% (95% confidence interval [CI] = 21% to 47%) of the intervention group and 1.6% of control group (number needed to treat = 3.1, 95% CI = 2.2 to 5.2, P<0.001). The levels of improvement in the intervention group ranged between 15 dB and 36 dB. The symptoms that most commonly improved included hearing on the phone, pain, a feeling of blocked ears, and hearing one-to-one. There was a strong relationship between the change thresholds, as measure using PTA, and self-reports of hearing improvement. Secondary analysis was unable to identify predictors of objectively measured improvement. CONCLUSION: Ear syringing improved hearing threshold in a substantial proportion of patients. An even larger proportion reported an improvement in symptoms. It was not possible to predict which patients would benefit.

Adult↗

PubMed2006

Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats.

BACKGROUND: Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. METHODS/DESIGN: A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4-15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001-July 2008). DISCUSSION: As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives.

Journal Article↗

PubMed2004

Effect of bottles, cups, and dummies on breast feeding in preterm infants: a randomised controlled trial.

OBJECTIVE: To determine the effect of artificial teats (bottle and dummy) and cups on breast feeding in preterm infants. DESIGN: Randomised controlled trial. SETTING: Two large tertiary hospitals, 54 peripheral hospitals. PARTICIPANTS: 319 preterm infants (born at 23-33 weeks' gestation) randomly assigned to one of four groups: cup/no dummy (n = 89), cup/dummy (n = 72), bottle/no dummy (n = 73), bottle/dummy (n = 85). Women with singleton or twin infants < 34 weeks' gestation who wanted to breastfeed were eligible to participate. INTERVENTIONS: Cup or bottle feeding occurred when the mother was unable to be present to breast feed. Infants randomised to the dummy groups received a dummy on entry into the trial. MAIN OUTCOME MEASURES: Full breast feeding (compared with partial and none) and any breast feeding (compared with none) on discharge home. SECONDARY OUTCOMES: prevalence of breast feeding at three and six months after discharge and length of hospital stay. RESULTS: 303 infants (and 278 mothers) were included in the intention to treat analysis. There were no significant differences for any of the study outcomes according to use of a dummy. Infants randomised to cup feeds were more likely to be fully breast fed on discharge home (odds ratio 1.73, 95% confidence interval 1.04 to 2.88, P = 0.03), but had a longer length of stay (hazard ratio 0.71, 0.55 to 0.92, P = 0.01). CONCLUSIONS: Dummies do not affect breast feeding in preterm infants. Cup feeding significantly increases the likelihood that the baby will be fully breast fed at discharge home, but has no effect on any breast feeding and increases the length of hospital stay.

Adult↗

PubMed2001

Postoperative astigmatism after intracapsular cataract surgery: results of a randomised controlled trial in Nepal.

PURPOSE: Postoperative astigmatism following intracapsular cataract extraction with or without anterior chamber intraocular lens implantation is reported as an outcome from a randomised controlled trial. METHODS: Five hundred and two of 1002 eyes randomised to intracapsular cataract extraction with anterior chamber intraocular lens (ICCE/AC IOL) and 417 of 998 eyes to intracapsular cataract extraction with aphakic spectacles (ICCE/AS) were seen for objective refraction one year after surgery. The prevalence and axis of astigmatism were evaluated using univariate analysis. Logistic regression was used to compare the postoperative astigmatism between the groups. RESULTS: Acceptable astigmatism (-0.5 to 0.0 DCyl) in the AC IOL group was found in 60 (12.0%) patients (95% CI 9.1%-14.9%) and in the aphakic spectacles group (AS) in 69 (16.5%) patients (95% CI 12.9%-20.1%), moderate astigmatism (-1.0 to-1.5 DCyl) was found in 153 (30.4%) patients (95% CI 26.4-34.6%) in ACIOL group and in 288 (69.1%) patients (95% CI 64.6%-73.6%) in AS group; and large astigmatism (-2.0 to - 8.0 D Cyl) was found in 289 (57.6%) patients (95% CI 53.1%-61.6%) in ACIOL group and in 60 (14.4%) patients (95% CI 11.0% 17.8%) in AS group. Large astigmatism was approximately four times more common in the ICCE/AC IOL group compared to ICCE/AS group. In both groups, most patients had "against-the-rule" astigmatism, 446 (88.8%) (95%CI 86.0%-91.6%) in AC IOL group and 348 (83.5%) (95%CI 79.9%-87.1%) in AS group. CONCLUSION: Astigmatism is common after intracapsular cataract extraction. Insertion of an anterior chamber IOL increases the risk of astigmatism.

Adolescent↗

PubMed1992

Follow-up results from a randomised controlled trial evaluating in- and outpatient pain management programmes.

This study reports a 9-18 month follow-up of a randomised controlled trial of pain management programmes for chronic, non-malignant pain. Twenty-two inpatients, 18 outpatients and 12 control subjects completed the follow-up assessments. Significant treatment effects were demonstrated by the inpatient group on pain ratings, the Pain Behaviour Checklist, and General Health Questionnaire, with similar effects demonstrated by the outpatient group on the former 2 measures. The findings were confounded by higher inpatient scores at pretreatment, in comparison with the 2 other conditions. There was a high drop-out rate of subjects, particularly from the control condition which illustrates the limitations of controlled group designs in this area. Analgesic use, activity levels and pain ratings were also evaluated using the criteria for 'success' described by Malec et al. (1981). Results indicated that 68% of inpatients, 61% of outpatients and 21% of control subjects met all 3 criteria. Both treatment programmes were effective in returning patients to paid employment, whilst 3 control group patients gave up work. The cost-benefit implications of these changes are discussed. We conclude that pain management programmes contribute substantially to the rehabilitation of chronic pain sufferers.

Ambulatory Care↗

PubMed2000

Results at 1 year of outpatient multidisciplinary pulmonary rehabilitation: a randomised controlled trial.

BACKGROUND: Pulmonary rehabilitation seems to be an effective intervention in patients with chronic obstructive pulmonary disease. We undertook a randomised controlled trial to assess the effect of outpatient pulmonary rehabilitation on use of health care and patients' wellbeing over 1 year. METHODS: 200 patients with disabling chronic lung disease (the majority with chronic obstructive pulmonary disease) were randomly assigned a 6-week multidisciplinary rehabilitation programme (18 visits) or standard medical management. Use of health services was assessed from hospital and general-practice records. Analysis was by intention to treat. FINDINGS: There was no difference between the rehabilitation (n=99) and control (n=101) groups in the number of patients admitted to hospital (40 vs 41) but the number of days these patients spent in hospital differed significantly (mean 10.4 [SD 9.7] vs 21.0 [20.7], p=0.022). The rehabilitation group had more primary-care consultations at the general-practitioner's premises than did the control group (8.6 [6.8] vs 7.3 [8.3], p=0.033) but fewer primary-care home visits (1.5 [2.8] vs 2.8 [4.6], p=0.037). Compared with control, the rehabilitation group also showed greater improvements in walking ability and in general and disease-specific health status. INTERPRETATION: For patients chronically disabled by obstructive pulmonary disease, an intensive, multidisciplinary, outpatient programme of rehabilitation is an effective intervention, in the short term and the long term, that decreases use of health services.

Aged↗

PubMed2002

Oral health care education and its effect on caregivers' knowledge and attitudes: a randomised controlled trial.

OBJECTIVES: The effect of an oral health care education programme (OHCE) upon nursing home caregivers was assessed in a randomised controlled trial. METHODS: A self-administered questionnaire assessed oral health care knowledge and attitudes at baseline among 369 caregivers working in 22 nursing homes. Homes were randomly allocated to two groups. The intervention was a workplace OHCE. Caregivers assessed the value of the presentations. Questionnaires were re-administered 1 month (time 2) and 6 months (time 3) after the OHCE was delivered. The knowledge and attitude score means of the groups were compared. Open-ended questions solicited qualitative data. RESULTS: Questionnaire response rates at the three time points ranged from 76.3% to 85.4%. Two-thirds of caregivers employed at the time of the intervention attended the presentations. The OHCE was favourably assessed in 79% of responses. The intervention group significantly improved their scores over the control group at times 2 and 3 for knowledge (P<0.003) and attitude (P<0.001). Analysed across both arms at baseline, the main predictors for knowledge and attitude scores were age and dental attendance pattern. Qualitative responses showed an acceptance of caregivers' roles in oral health care and criticism of existing provision within homes. CONCLUSIONS: The OHCE was well received and resulted in improved oral health care knowledge and attitudes. When viewed with separately reported trial results of clients' oral health status, knowledge and attitude score improvements coincided with improved delivery of oral health care.

Adolescent↗

PubMed2000

Nifedipine or prazosin as a second agent to control early severe hypertension in pregnancy: a randomised controlled trial.

OBJECTIVE: To determine whether nifedipine or prazosin is the more appropriate second-line antihypertensive agent in pregnancy. DESIGN: Randomised controlled trial. SETTING: Tygerberg Hospital, a tertiary referral centre. POPULATION: Women with early, severe pre-eclampsia or hypertension in pregnancy, whose blood pressure could not be adequately controlled by methyldopa 2 g/day, but were otherwise stable. METHODS: Nifedipine or prazosin were given and increased as necessary in a stepwise fashion. Once the maximum dose was reached, the other drug was added in a crossover pattern. Failure to control blood pressure, or the onset of maternal/fetal complications were indications for delivery. Patients reaching a minimum gestation of 34 weeks without complications were delivered electively. MAIN OUTCOME MEASURES: Antenatal days gained; major maternal complications and perinatal survival. RESULTS: Days gained on the second antihypertensive agent did not differ significantly (P = 0.9), while more days were gained using nifedipine as the crossover 'third agent' (P = 0.01). In the nifedipine group better renal function was recorded, but more cases with isolated low platelet counts occurred. More cases of pulmonary oedema as well as more nonviable mid-trimester and third trimester intrauterine deaths occurred in the prazosin group. CONCLUSION: Nifedipine and prazosin as second agents allowed comparable amounts of time to be gained, although this changed when used as crossover third-line agents. The efficacy and safety of nifedipine in this study are consistent with the results of other studies. A greater number of intrauterine deaths occurred in the prazosin group.

Antihypertensive Agents↗

PubMed2003

Antibiotics and surgery for vesicoureteric reflux: a meta-analysis of randomised controlled trials.

AIMS: To evaluate the benefits and harms of treatments for vesicoureteric reflux in children. METHODS: Meta-analyses of randomised controlled trials using a random effects model. Main outcome measures were incidence of urinary tract infection (UTI), new or progressive renal damage, renal growth, hypertension, and glomerular filtration rate. RESULTS: Eight trials involving 859 evaluable children comparing long term antibiotics with surgical correction of reflux (VUR) and antibiotics (seven trials) and antibiotics compared with no treatment (one trial) were identified. Risk of UTI by 1-2 and 5 years was not significantly different between surgical and medical groups (relative risk (RR) by 2 years 1.07; 95% confidence interval (CI) 0.55 to 2.09, RR by 5 years 0.99; 95% CI 0.79 to 1.26). Combined treatment resulted in a 60% reduction in febrile UTI by 5 years (RR 0.43; 95% CI 0.27 to 0.70) but no concomitant significant reduction in risk of new or progressive renal damage at 5 years (RR 1.05; 95% CI 0.85 to 1.29). In one small study no significant differences in risk for UTI or renal damage were found between antibiotic prophylaxis and no treatment. CONCLUSION: It is uncertain whether the identification and treatment of children with VUR confers clinically important benefit. The additional benefit of surgery over antibiotics alone is small at best. Assuming a UTI rate of 20% for children with VUR on antibiotics for five years, nine reimplantations would be required to prevent one febrile UTI, with no reduction in the number of children developing any UTI or renal damage.

Adolescent↗

PubMed2002

Brief intervention during hospital admission to help patients to give up smoking after myocardial infarction and bypass surgery: randomised controlled trial.

OBJECTIVE: To evaluate a smoking cessation intervention that can be routinely delivered to smokers admitted with cardiac problems. DESIGN: Randomised controlled trial of usual care compared with intervention delivered on hospital wards by cardiac rehabilitation nurses. SETTING: Inpatient wards in 17 hospitals in England. PARTICIPANTS: 540 smokers admitted to hospital after myocardial infarction or for cardiac bypass surgery who expressed interest in stopping smoking. INTERVENTION: Brief verbal advice and standard booklet (usual care). Intervention lasting 20-30 minutes including carbon monoxide reading, special booklet, quiz, contact with other people giving up, declaration of commitment to give up, sticker in patient's notes (intervention group). MAIN OUTCOME MEASURES: Continuous abstinence at six weeks and 12 months determined by self report and by biochemical validation at these end points. Feasibility of the intervention and delivery of its components. RESULTS: After six weeks 151 (59%) and 159 (60%) patients remained abstinent in the control and intervention group, respectively (P=0.84). After 12 months the figures were 102 (41%) and 94 (37%) (P=0.40). Recruitment was slow, and delivery of the intervention was inconsistent, raising concerns about the feasibility of the intervention within routine care. Patients who received the declaration of commitment component were almost twice as likely to remain abstinent than those who did not receive it (P<0.01). Low dependence on tobacco and high motivation to give up were the main independent predictors of positive outcome. Patients who had had bypass surgery were over twice as likely to return to smoking as patients who had had a myocardial infarction. CONCLUSIONS: Single session interventions delivered within routine care may have insufficient power to influence highly dependent smokers.

Adult↗

PubMed2002

Effectiveness of teaching general practitioners skills in brief cognitive behaviour therapy to treat patients with depression: randomised controlled trial.

OBJECTIVE: To assess the effectiveness of teaching general practitioners skills in brief cognitive behaviour therapy. DESIGN: Parallel group, cluster randomised, controlled trial of an educational package on cognitive behaviour therapy. SETTING: General practices in north London. PARTICIPANTS: 84 general practitioner principals and 272 patients attending their practices who scored above the threshold for psychological distress on the hospital anxiety and depression scale. INTERVENTION: A training package of four half days on brief cognitive behaviour therapy. MAIN OUTCOME MEASURES: Scores on the depression attitude questionnaire (general practitioners) and the Beck depression inventory (patients). RESULTS: Doctors' knowledge of depression and attitudes towards its treatment showed no major difference between intervention and control groups after 6 months. The training had no discernible impact on patients' outcomes. CONCLUSION: General practitioners may require more training and support than a basic educational package on brief cognitive behaviour therapy to acquire skills to help patients with depression.

Adolescent↗

PubMed2004

Impact of nurse practitioners on workload of general practitioners: randomised controlled trial.

OBJECTIVE: To examine the impact on general practitioners' workload of adding nurse practitioners to the general practice team. DESIGN: Randomised controlled trial with measurements before and after the introduction of nurse practitioners. SETTING: 34 general practices in a southern region of the Netherlands. PARTICIPANTS: 48 general practitioners. INTERVENTION: Five nurses were randomly allocated to general practitioners to undertake specific elements of care according to agreed guidelines. The control group received no nurse. MAIN OUTCOME MEASURES: Objective workload, derived from 28 day diaries, included the number of contacts per day for each of three conditions (chronic obstructive pulmonary disease or asthma, dementia, cancer), by type of consultation (in practice, telephone, home visit), and by time of day (surgery hours, out of hours). Subjective workload was measured by using a validated questionnaire. Outcomes were measured six months before and 18 months after the intervention. RESULTS: The number of contacts during surgery hours increased in the intervention group compared with the control group (P < 0.06), particularly for patients with chronic obstructive pulmonary disease or asthma (P < 0.01). The number of consultations out of hours declined slightly in the intervention group compared with the control group, but this difference did not reach significance. No significant changes became apparent in subjective workload. CONCLUSION: Adding nurse practitioners to general practice teams did not reduce the workload of general practitioners, at least in the short term. This implies that nurse practitioners are used as supplements, rather than substitutes, for care given by general practitioners.

Family Practice↗

PubMed1999

Searching for the evidence in pre-hospital care: a review of randomised controlled trials. On behalf of the Ambulance Response Time Sub-Group of the National Ambulance Advisory Committee.

OBJECTIVES: To identify randomised controlled trials (RCTs) which evaluate aspects of pre-hospital care; to perform categorisation by theme; to compare the sensitivity and precision of the search databases. DATA SOURCES: August 1997 updates of MEDLINE and EMBASE databases, using the Datastar online system. Papers published in 1987 or later were included, with no language restrictions. STUDY SELECTION: A trial was eligible for inclusion if it was judged, by two independent and blinded assessors, that participants followed up in the trial were definitely or possibly assigned prospectively to one of two or more alternative forms of healthcare with random allocation or a quasi-random method of allocation. RESULTS: The literature search retrieved 849 papers, of which 569 (67%) were in MEDLINE and 486 (57%) in EMBASE. Forty one (5%) were confirmed as reports of RCTs or quasi-RCTs, and the total number of individual trials was 38. Ten of these trials dealt with thrombolytic drugs; 14 were concerned with other drugs, 12 with equipment, and two with other interventions. Four trials were based on a sample size of more than 1000, and seven reported a statistically significant effect on mortality. All 41 papers were in EMBASE, and all but one were also in MEDLINE. CONCLUSIONS: Evidence based policy making with respect to the organisation of pre-hospital services cannot depend on RCTs. In the current relative absence of such evidence, practitioners and decision makers must use alternative information sources. A future review could examine a broader range of literature and be based on a wider search of published and unpublished material.

Abstracting and Indexing↗

PubMed1998

London-east Anglia randomised controlled trial of cognitive-behavioural therapy for psychosis. III: Follow-up and economic evaluation at 18 months.

BACKGROUND: A randomised controlled trial of cognitive-behavioural therapy (CBT) for people with medication-resistant psychosis showed improvements in overall symptomatology after nine months of treatment; good outcome was strongly predicted by a measure of cognitive flexibility concerning delusions. The present paper presents a follow-up evaluation 18 months after baseline. METHOD: Forty-seven (78% of original n = 60) participants were available for follow-up at 18 months, and were reassessed on all the original outcome measures (see Part I). An economic evaluation was also completed. RESULTS: Those in the CBT treatment group showed a significant and continuing improvement in Brief Psychiatric Rating Scale scores, whereas the control group did not change from baseline. Delusional distress and the frequency of hallucinations were also significantly reduced in the CBT group. The costs of CBT appear to have been offset by reductions in service utilisation and associated costs during follow-up. CONCLUSIONS: Improvement in overall symptoms was maintained in the CBT group 18 months after baseline and nine months after intensive therapy was completed. CBT may be a specific and cost-effective intervention in medication-resistant psychosis.

Adult↗

PubMed2005

Patients with recurrent falls attending Accident & Emergency benefit from multifactorial intervention--a randomised controlled trial.

OBJECTIVES: To determine the effectiveness of multifactorial intervention to prevent falls in cognitively intact older persons with recurrent falls. DESIGN: Randomised controlled trial of multifactorial (medical, physiotherapy and occupational therapy) post-fall assessment and intervention compared with conventional care. SETTING: Accident & Emergency departments in a university teaching hospital and associated district general hospital. SUBJECTS: 313 cognitively intact men and women aged over 65 years presenting to Accident & Emergency with a fall or fall-related injury and at least one additional fall in the preceding year; 159 randomised to assessment and intervention and 154 to conventional care. OUTCOME MEASURES: primary outcome was the number of falls and fallers in 1 year after recruitment. Secondary outcomes included injury rates, fall-related hospital admissions, mortality and fear of falling. RESULTS: There were 36% fewer falls in the intervention group (relative risk 0.64, 95% confidence interval 0.46-0.90). The proportion of subjects continuing to fall (65% (94/144) compared with 68% (102/149) relative risk 0.95, 95% confidence interval 0.81-1.12), and the number of fall-related attendances and hospital admissions was not different between groups. Duration of hospital admission was reduced (mean difference admission duration 3.6 days, 95% confidence interval 0.1-7.6) and falls efficacy was better in the intervention group (mean difference in Activities Specific Balance Confidence Score of 7.5, 95% confidence interval 0.72-14.2). CONCLUSION: Multifactorial intervention is effective at reducing the fall burden in cognitively intact older persons with recurrent falls attending Accident & Emergency, but does not reduce the proportion of subjects still falling.

Accidental Falls↗

PubMed2004

A pilot study for a randomised controlled trial of waterbirth versus land birth.

OBJECTIVES: To assess the feasibility of undertaking an adequately powered multicentre study comparing waterbirth with land birth. To assess whether women are willing to participate in such a trial and whether participation has a negative effect on their birthing experience. DESIGN: A randomised controlled trial (RCT) with 'preference arm'. SETTING: District general hospital with 3600 deliveries annually. POPULATION: Women with no pregnancy complications and no anticipated problems for labour/delivery. METHODS: Women were recruited and randomised between 36 and 40 weeks of gestation. Comparison of randomised and 'preference arm' to assess any impact of randomisation on women's birthing experience. MAIN OUTCOME MEASURES: Data were collected at delivery concerning the labour, the pool water and baby's condition at birth and six weeks of age. The main outcome measures are means and standard deviation of cord O(2), CO(2), haemoglobin, haematocrit and base excess; medians and ranges of time to first breathe and cord pH; bacterial growth from pool water samples and neonatal swabs; and maternal satisfaction. RESULTS: Eighty women participated-60 women were randomised. Twenty women participated in a non-randomised 'preference arm'. The babies randomised to a waterbirth demonstrated a significantly lower umbilical artery pCO(2) (P= 0.003); however, it is recognised that this study is underpowered. Women were willing to participate and randomisation did not appear to alter satisfaction. CONCLUSION: This small study has shown that a RCT is feasible and demonstrated outcome measures, which can be successfully collected in an average delivery suite.

Adolescent↗

PubMed1991

Randomised controlled trial of the effectiveness of a respiratory health worker in reducing impairment, disability, and handicap due to chronic airflow limitation.

A randomised controlled trial was undertaken to determine whether a respiratory health worker was effective in reducing the respiratory impairment, disability, and handicap experienced by patients with chronic airflow limitation attending a respiratory outpatient department. The 152 adults (aged 30-75 years) who participated had a prebronchodilator forced expiratory volume in one second (FEV1) below 60% predicted and no other disease. They were randomised to receive the care of a respiratory health worker or the normal services provided by the outpatient department. The respiratory health worker provided health education and symptom and treatment monitoring in liaison with primary care services. After one year there was little difference between the two groups in spirometric values (FEV1 and forced vital capacity before and after salbutamol 200 micrograms), disability (six minute walking distance and paced step test), and handicap (sickness impact profile, hospital anxiety and depression scale). Patients not looked after by the respiratory health worker were more likely to die (relative risk 2.9 (95% confidence limits 0.8, 10.2); when age and FEV1 were controlled for this risk increased to 5.5 (95% confidence limits 1.2, 24.5). Patients looked after by the respiratory health worker attended their general practitioner more frequently and were prescribed a greater range of drugs. This is the third study to have found limited measurable benefit in terms of morbidity from the intervention of a respiratory health worker. This may be due to the ability of such workers to keep frail patients alive.

Adult↗