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Do clinical guidelines introduced with practice based education improve care of asthmatic and diabetic patients? A randomised controlled trial in general practices in east London.

OBJECTIVE: To determine whether locally developed guidelines on asthma and diabetes disseminated through practice based education improve quality of care in non-training, inner city general practices. DESIGN: Randomised controlled trial with each practice receiving one set of guidelines but providing data on the management of both conditions. SUBJECTS: 24 inner city, non-training general practices. SETTING: East London. MAIN OUTCOME MEASURES: Recording of key variables in patient records (asthma: peak flow rate, review of inhaler technique, review of asthma symptoms, prophylaxis, occupation, and smoking habit; diabetes: blood glucose concentration, glycaemic control, funduscopy, feet examination, weight, and smoking habit); size of practice disease registers; prescribing in asthma; and use of structured consultation "prompts." RESULTS: In practices receiving diabetes guidelines, significant improvements in recording were seen for all seven diabetes variables. Both groups of practices showed improved recording of review of inhaler technique, smoking habit, and review of asthma symptoms. In practices receiving asthma guidelines, further improvement was seen only in recording of review of inhaler technique and quality of prescribing in asthma. Sizes of disease registers were unchanged. The use of structured prompts was associated with improved recording of four of seven variables on diabetes and all six variables on asthma. CONCLUSIONS: Local guidelines disseminated via practice based education improve the management of diabetes and possibly of asthma in inner city, non-training practices. The use of simple prompts may enhance this improvement.

Adult↗

Compliance therapy in psychotic patients: randomised controlled trial.

OBJECTIVE: To determine whether compliance therapy, a cognitive-behavioural intervention, could improve compliance with treatment and hence social adjustment in acutely psychotic inpatients, and if so, whether the effect persisted six months later. DESIGN: Randomised controlled trial of compliance therapy and non-specific counselling, each comprising 4-6 sessions lasting 10-60 minutes. SETTING: Acute psychiatric admissions ward serving an inner London catchment area. SUBJECTS: 47 patients with psychosis. MAIN OUTCOME MEASURES: Informant and observer reported measure of compliance; observer assessed global functioning after intervention and three and six months later; self-rated attitudes to drug treatment after the intervention and one month later; symptom scores after intervention and six months later. RESULTS: 25 patients received compliance therapy and showed significantly greater improvements in their attitudes to drug treatment and in their insight into illness and compliance with treatment compared with the control group. These gains persisted for six months. The intervention group was 5.2 times more likely than the control group to reach a criterion level of compliance (95% confidence interval 1.5 to 18.3). Global functioning showed a tendency to improve more in the intervention group after a delay (odds ratio 3.0 (0.8 to 11.5) to reach the criterion level at six months). Four subjects given compliance therapy and six in the control group were readmitted during follow up (odds ratio 2.0 (0.48 to 8.2)). CONCLUSIONS: Compliance therapy is a pragmatic method for improving compliance with drug treatment in psychotic inpatients and its gains persist for at least six months. Overall functioning may also be enhanced.

Acute Disease↗

Should obstetricians see women with normal pregnancies? A multicentre randomised controlled trial of routine antenatal care by general practitioners and midwives compared with shared care led by obstetricians.

OBJECTIVE: To compare routine antenatal care provided by general practitioners and midwives with obstetrician led shared care. DESIGN: Multicentre randomised controlled trial. SETTING: 51 general practices linked to nine Scottish maternity hospitals. SUBJECTS: 1765 women at low risk of antenatal complications. INTERVENTION: Routine antenatal care by general practitioners and midwives according to a care plan and protocols for managing complications. MAIN OUTCOME MEASURES: Comparisons of health service use, indicators of quality of care, and women's satisfaction. RESULTS: Continuity of care was improved for the general practitioner and midwife group as the number of carers was less (median 5 carers v 7 for shared care group, P<0.0001) and the number of routine visits reduced (10.9 v 11.7, P<0.0001). Fewer women in the general practitioner and midwife group had antenatal admissions (27% (222/834) v 32% (266/840), P<0.05), non-attendances (7% (57) v 11% (89), P<0.01) and daycare (12% (102) v 7% (139), P<0.05) but more were referred (49% (406) v 36% (305), P<0.0001). Rates of antenatal diagnoses did not differ except that fewer women in the general practitioner and midwife group had hypertensive disorders (pregnancy induced hypertension, 5% (37) v 8% (70), P<0.01) and fewer had labour induced (18% (149) v 24% (201), P<0.01). Few failures to comply with the care protocol occurred, but more Rhesus negative women in the general practitioner and midwife group did not have an appropriate antibody check (2.5% (20) v 0.4% (3), P<0.0001). Both groups expressed high satisfaction with care (68% (453/663) v 65% (430/656), P=0.5) and acceptability of allocated style of care (93% (618) v 94% (624), P=0.6). Access to hospital support before labour was similar (45% (302) v 48% (312) visited labour rooms before giving birth, P=0.6). CONCLUSION: Routine specialist visits for women initially at low risk of pregnancy complications offer little or no clinical or consumer benefit.

Clinical Protocols↗

Benefit of heparin in peripheral venous and arterial catheters: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To evaluate the effect of heparin on duration of catheter patency and on prevention of complications associated with use of peripheral venous and arterial catheters. DESIGN: Critical appraisal and meta-analysis of 26 randomised controlled trials that evaluated infusion of heparin intermittently or continuously. Thirteen trials of peripheral venous catheters and two of peripheral arterial catheters met criteria for inclusion. MAIN OUTCOME MEASURES: Data on the populations, interventions, outcomes, and methodological quality. RESULTS: For peripheral venous catheters locked between use flushing with 10 U/ml of heparin instead of normal saline did not reduce the incidence of catheter clotting and phlebitis or improve catheter patency. When heparin was given as a continuous infusion at 1 U/ml the risk of phlebitis decreased (relative risk 0.55; 95% confidence interval 0.39 to 0.77), the duration of patency increased, and infusion failure was reduced (0.88; 0.72 to 1.07). Heparin significantly prolonged duration of patency of radial artery catheters and decreased the risk of clot formation (0.51; 0.42 to 0.61). CONCLUSIONS: Use of intermittent heparin flushes at doses of 10 U/ml in peripheral venous catheters locked between use had no benefit over normal saline flush. Infusion of low dose heparin through a peripheral arterial catheter prolonged the duration of patency but further study is needed to establish its benefit for peripheral venous catheters.

Adolescent↗

Multicentre randomised controlled trial of nursing intervention for breathlessness in patients with lung cancer.

OBJECTIVE: To evaluate the effectiveness of nursing intervention for breathlessness in patients with lung cancer. DESIGN: Patients diagnosed with lung cancer participated in a multicentre randomised controlled trial where they either attended a nursing clinic offering intervention for their breathlessness or received best supportive care. The intervention consisted of a range of strategies combining breathing control, activity pacing, relaxation techniques, and psychosocial support. Best supportive care involved receiving standard management and treatment available for breathlessness, and breathing assessments. Participants completed a range of self assessment questionnaires at baseline, 4 weeks, and 8 weeks. SETTING: Nursing clinics within 6 hospital settings in the United Kingdom. PARTICIPANTS: 119 patients diagnosed with small cell or non-small cell lung cancer or with mesothelioma who had completed first line treatment for their disease and reported breathlessness. OUTCOME MEASURES: Visual analogue scales measuring distress due to breathlessness, breathlessness at best and worst, WHO performance status scale, hospital anxiety and depression scale, and Rotterdam symptom checklist. RESULTS: The intervention group improved significantly at 8 weeks in 5 of the 11 items assessed: breathlessness at best, WHO performance status, levels of depression, and two Rotterdam symptom checklist measures (physical symptom distress and breathlessness) and showed slight improvement in 3 of the remaining 6 items. CONCLUSION: Most patients who completed the study had a poor prognosis, and breathlessness was typically a symptom of their deteriorating condition. Patients who attended nursing clinics and received the breathlessness intervention experienced improvements in breathlessness, performance status, and physical and emotional states relative to control patients.

Anxiety↗

Problem solving treatment and group psychoeducation for depression: multicentre randomised controlled trial. Outcomes of Depression International Network (ODIN) Group.

OBJECTIVES: To determine the acceptability of two psychological interventions for depressed adults in the community and their effect on caseness, symptoms, and subjective function. DESIGN: A pragmatic multicentre randomised controlled trial, stratified by centre. SETTING: Nine urban and rural communities in Finland, Republic of Ireland, Norway, Spain, and the United Kingdom. PARTICIPANTS: 452 participants aged 18 to 65, identified through a community survey with depressive or adjustment disorders according to the international classification of diseases, 10th revision or Diagnostic and Statistical Manual of Mental Disorders, fourth edition. INTERVENTIONS: Six individual sessions of problem solving treatment (n=128), eight group sessions of the course on prevention of depression (n=108), and controls (n=189). MAIN OUTCOME MEASURES: Completion rates for each intervention, diagnosis of depression, and depressive symptoms and subjective function. RESULTS: 63% of participants assigned to problem solving and 44% assigned to prevention of depression completed their intervention. The proportion of problem solving participants depressed at six months was 17% less than that for controls, giving a number needed to treat of 6; the mean difference in Beck depression inventory score was -2. 63 (95% confidence interval -4.95 to -0.32), and there were significant improvements in SF-36 scores. For depression prevention, the difference in proportions of depressed participants was 14% (number needed to treat of 7); the mean difference in Beck depression inventory score was -1.50 (-4.16 to 1.17), and there were significant improvements in SF-36 scores. Such differences were not observed at 12 months. Neither specific diagnosis nor treatment with antidepressants affected outcome. CONCLUSIONS: When offered to adults with depressive disorders in the community, problem solving treatment was more acceptable than the course on prevention of depression. Both interventions reduced caseness and improved subjective function.

Adolescent↗

Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 1: Randomised controlled trial.

OBJECTIVES: To assess the effectiveness of a trained district nurse individually prescribing a home based exercise programme to reduce falls and injuries in elderly people and to estimate the cost effectiveness of the programme. DESIGN: Randomised controlled trial with one year's follow up. SETTING: Community health service at a New Zealand hospital. PARTICIPANTS: 240 women and men aged 75 years and older. INTERVENTION: 121 participants received the exercise programme (exercise group) and 119 received usual care (control group); 90% (211 of 233) completed the trial. MAIN OUTCOME MEASURES: Number of falls, number of injuries resulting from falls, costs of implementing the programme, and hospital costs as a result of falls. RESULTS: Falls were reduced by 46% (incidence rate ratio 0.54, 95% confidence interval 0.32 to 0.90). Five hospital admissions were due to injuries caused by falls in the control group and none in the exercise group. The programme cost $NZ1803 (523 pound sterling) (at 1998 prices) per fall prevented for delivering the programme and $NZ155 per fall prevented when hospital costs averted were considered. CONCLUSION: A home exercise programme, previously shown to be successful when delivered by a physiotherapist, was also effective in reducing falls when delivered by a trained nurse from within a home health service. Serious injuries and hospital admissions due to falls were also reduced. The programme was cost effective in participants aged 80 years and older compared with younger participants.

Accidental Falls↗

Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomised controlled trial.

OBJECTIVE: To assess the effects of didgeridoo playing on daytime sleepiness and other outcomes related to sleep by reducing collapsibility of the upper airways in patients with moderate obstructive sleep apnoea syndrome and snoring. DESIGN: Randomised controlled trial. SETTING: Private practice of a didgeridoo instructor and a single centre for sleep medicine. PARTICIPANTS: 25 patients aged > 18 years with an apnoea-hypopnoea index between 15 and 30 and who complained about snoring. INTERVENTIONS: Didgeridoo lessons and daily practice at home with standardised instruments for four months. Participants in the control group remained on the waiting list for lessons. MAIN OUTCOME MEASURE: Daytime sleepiness (Epworth scale from 0 (no daytime sleepiness) to 24), sleep quality (Pittsburgh quality of sleep index from 0 (excellent sleep quality) to 21), partner rating of sleep disturbance (visual analogue scale from 0 (not disturbed) to 10), apnoea-hypopnoea index, and health related quality of life (SF-36). RESULTS: Participants in the didgeridoo group practised an average of 5.9 days a week (SD 0.86) for 25.3 minutes (SD 3.4). Compared with the control group in the didgeridoo group daytime sleepiness (difference -3.0, 95% confidence interval -5.7 to -0.3, P = 0.03) and apnoea-hypopnoea index (difference -6.2, -12.3 to -0.1, P = 0.05) improved significantly and partners reported less sleep disturbance (difference -2.8, -4.7 to -0.9, P < 0.01). There was no effect on the quality of sleep (difference -0.7, -2.1 to 0.6, P = 0.27). The combined analysis of sleep related outcomes showed a moderate to large effect of didgeridoo playing (difference between summary z scores -0.78 SD units, -1.27 to -0.28, P < 0.01). Changes in health related quality of life did not differ between groups. CONCLUSION: Regular didgeridoo playing is an effective treatment alternative well accepted by patients with moderate obstructive sleep apnoea syndrome. Trial registration ISRCTN: 31571714.

Adult↗

Sham device v inert pill: randomised controlled trial of two placebo treatments.

OBJECTIVE: To investigate whether a sham device (a validated sham acupuncture needle) has a greater placebo effect than an inert pill in patients with persistent arm pain. DESIGN: A single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study. SETTING: Academic medical centre. PARTICIPANTS: 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored > or =3 on a 10 point pain scale. INTERVENTIONS: Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks. MAIN OUTCOME MEASURES: Arm pain measured on a 10 point pain scale. Secondary outcomes were symptoms measured by the Levine symptom severity scale, function measured by Pransky's upper extremity function scale, and grip strength. RESULTS: Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups, but changes were not different between the groups (-0.14, 95% confidence interval -0.52 to 0.25, P = 0.49). Changes in severity scores for arm symptoms and grip strength were similar between groups, but arm function improved more in the placebo pill group (2.0, 0.06 to 3.92, P = 0.04). Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group (-0.33 (-0.40 to -0.26) v -0.15 (-0.21 to -0.09), P = 0.0001) and on the symptom severity scale (-0.07 (-0.09 to -0.05) v -0.05 (-0.06 to -0.03), P = 0.02). Differences were not significant, however, on the function scale or for grip strength. Reported adverse effects were different in the two groups. CONCLUSIONS: The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in. Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals.

Acupuncture Analgesia↗

Dextrose 10% or 50% in the treatment of hypoglycaemia out of hospital? A randomised controlled trial.

OBJECTIVE: To investigate whether 10% dextrose given in 5 g (50 ml) aliquots is more effective than 50% dextrose given in 5 g (10 ml) aliquots in the treatment of out of hospital hypoglycaemia. DESIGN: Randomised controlled trial. SETTING: Out of hospital patients attended by paramedics from a large UK ambulance service. PARTICIPANTS: 51 unresponsive adult patients with blood glucose levels < or = 4 mmol/l. INTERVENTION: 5 g (50 ml) intravenous aliquots of 10% dextrose or 5 g (10 ml) intravenous aliquots of 50% dextrose to a maximum dose of 25 g. MAIN OUTCOME MEASURES: To compare for each dextrose concentration the time to achieve a Glasgow Coma Scale (GCS) score of 15, and the dose required to obtain a blood glucose level of > or = 4.5 mmol/l. RESULTS: There were no statistically significant differences between the groups with regard to age or sex, median pretreatment GCS, pretreatment blood glucose level, or proportion of patients with insulin dependent diabetes. Following treatment, there were no statistically significant differences in median time to recovery (8 minutes), median post-treatment GCS, or number of subjects experiencing a further hypoglycaemic episode within 24 hours (four per group). The median total dose of dextrose administered was significantly less with the 10% concentration (10% = 10 g, 50% = 25 g, p < 0.001) and median post-treatment blood sugar levels were also significantly lower (10% = 6.2 mmol/l and 50% = 9.4 mmol/l, p = 0.003). There were no reports of extravasation injuries in either group. CONCLUSIONS: Dextrose 10% delivered in 5 g (50 ml) aliquots is administered in smaller doses than dextrose 50% delivered in 5 g/10 ml aliquots, resulting in lower post-treatment blood glucose levels. We therefore recommend it as the intravenous treatment of choice for adult hypoglycaemia.

Adult↗

Does early imaging influence management and improve outcome in patients with low back pain? A pragmatic randomised controlled trial.

OBJECTIVES: To establish whether the early use of sophisticated imaging techniques influences the clinical management and outcome of patients with low back pain (LBP) and whether it is cost-effective. DESIGN: A pragmatic multicentre randomised controlled trial using a standard two parallel group approach incorporating an economic evaluation. For a subgroup of trial participants, a controlled 'before and after' approach was used to assess the impact of 'early imaging' on clinicians' diagnostic and therapeutic confidence. SETTING AND PARTICIPANTS: A total of 782 participants who had been referred by their general practitioner to a consultant orthopaedic specialist or neurosurgeon because of symptomatic lumbar spine disorders. The study included 14 hospitals in Scotland and one in England over a 24-month period. RESULTS: Participants in both groups reported an improvement in health status at 8 and 24 months with the 'early imaging' group having statistically significantly better outcome. Other than the proportion of participants receiving imaging (90% versus 30%), there were few differences between the groups in the management received throughout the 24-month follow-up. The total number of outpatient consultations in the two groups was similar although more people in the 'early imaging' group had return outpatient appointments during the 8-month follow-up. Clinicians' diagnostic confidence, between trial entry and follow-up, increased significantly for both groups with a greater increase in the 'early imaging' group. The cost of imaging was the main determinant of the difference in total costs between the groups and it was estimated that 'early imaging' could provide an additional 0.07 quality-adjusted life-years (QALYs), at an additional average cost of 61 British pounds over the 24-month follow-up. Using non-imputed costs and QALYs but adjusted for baseline differences in EQ-5D score, the mean incremental cost per QALY of 'early imaging' was 870 British pounds. The results were sensitive to the costs of imaging and the confidence intervals surrounding estimates of average costs and QALYs. CONCLUSIONS: The early use of sophisticated imaging does not appear to affect management overall but does result in a slight improvement in clinical outcome at an estimated cost of 870 British pounds per QALY. Imaging was associated with an increase in clinicians' diagnostic confidence, particularly for non-specialists. Further research is required to determine if more rapid referral to sophisticated imaging and secondary care is important in the acute episode and whether the use of imaging would be more beneficial for particular categories of LBP.

Adult↗

Antisepsis for abdominal hysterectomy: a randomised controlled trial of povidone-iodine gel.

OBJECTIVE: To assess whether infectious morbidity after total abdominal hysterectomy is decreased by the addition of 20 cc povidone-iodine gel at the vaginal apex after the usual vaginal preparation with povidone-iodine solution. STUDY DESIGN: Randomised controlled trial. SETTING: Fifteen secondary and tertiary hospitals in Canada. SAMPLE: A total of 1570 women undergoing planned total abdominal hysterectomy. METHODS: Computer-generated randomisation using a centralised telephone service was stratified by study centre with variable block size. In the operating room, a swab for bacterial vaginosis was taken before vaginal antisepsis. Study group remained concealed until the standard surgical preparation in the operating room was complete. Then povidone-iodine gel 20 cc was placed at the vaginal apex in the intervention group only. Participants were followed for one month post-operative. MAIN OUTCOME MEASURES: The primary outcome was post-operative infectious morbidity during the 30 days after surgery, defined as: febrile morbidity with hospital stay greater than five days or antibiotic treatment, or infection requiring readmission to hospital or additional visit. Other outcomes included abdominal wound infection, pelvic abscess and other pelvic infections. RESULTS: Post-operative infectious morbidity within 30 days occurred in 128/780 (16%) women receiving povidone-iodine gel preparation and 142/790 (18%) women not receiving gel (RR 0.9, 95% CI 0.7 to 1.1). Pelvic abscess was diagnosed in 0 patients in the gel group and in seven patients in the control group (P < 0.01). No significant difference was found in pelvic cellulitis (eight in each group) or abdominal wound infection (51 in the gel group and 58 in the control group, P= 0.5). CONCLUSION: Povidone-iodine vaginal gel antisepsis led to a 9% relative decrease in overall infectious morbidity after abdominal hysterectomy, which was not statistically significant. Povidone-iodine vaginal gel decreased the risk of pelvic abscess after total abdominal hysterectomy.

Abscess↗

Alternative strategies for stroke care: a prospective randomised controlled trial.

BACKGROUND: Organised specialist care for stroke improves outcome, but the merits of different methods of organisation are in doubt. This study compares the efficacy of stroke unit with stroke team or domiciliary care. METHODS: A single-blind, randomised, controlled trial was undertaken in 457 acute-stroke patients (average age 76 years, 48% women) randomly assigned to stroke unit, general wards with stroke team support, or domiciliary stroke care, within 72 h of stroke onset. Outcome was assessed at 3, 6, and 12 months. The primary outcome measure was death or institutionalisation at 12 months. Analyses were by intention to treat. FINDINGS: 152 patients were allocated to the stroke unit, 152 to stroke team, and 153 to domiciliary stroke care. 51 (34%) patients in the domiciliary group were admitted to hospital after randomisation. Mortality or institutionalisation at 1 year were lower in patients on a stroke unit than for those receiving care from a stroke team (21/152 [14%] vs 45/149 [30%]; p<0.001) or domiciliary care (21/152 [14%] vs 34/144 [24%]; p=0.03), mainly as a result of reduction in mortality. The proportion of patients alive without severe disability at 1 year was also significantly higher on the stroke unit compared with stroke team (129/152 [85%] vs 99/149 [66%]; p<0.001) or domiciliary care (129/152 [85%] vs 102/144 [71%]; p=0.002). These differences were present at 3 and 6 months after stroke. INTERPRETATION: Stroke units are more effective than a specialist stroke team or specialist domiciliary care in reducing mortality, institutionalisation, and dependence after stroke.

Aged↗

PEDro: a database of randomised controlled trials in physiotherapy.

PEDro is a database of clinical trials designed to assist the practice of evidence-based physiotherapy. When complete, it will contain bibliographic details, abstracts and quality assessment scores of all published randomised controlled trials in physiotherapy. Trials on the database will be rated on the basis of their methodological quality, so that users of the database can be guided to those trials which provide the most methodologically sound sources of evidence. The database has been made freely available on the world wide web, where it can be searched with a powerful and user-friendly search engine.

Australia↗

Intrapartum foetal heart rate monitoring--continuous electronic versus intermittent Doppler--a randomised controlled trial.

OBJECTIVE: To compare different methods of intrapartum foetal heart rate monitoring in high risk pregnancies in detecting foetal heart rate abnormalities, need for operative delivery for foetal distress, and neonatal mortality and short term neonatal morbidity. DESIGN: A prospective randomised controlled trial. SETTING: Women in labour at a referral maternity hospital. PATIENTS: Women who were 37 weeks or more pregnant with singleton cephalic presentation and normal foetal heart rate prior to entry into the study. INTERVENTION: Women were randomly allocated using sealed opaque envelopes to either continuous electronic foetal heart rate monitoring or intermittent monitoring using hand held doppler foetal heart rate detector. OUTCOME MEASURES: These include abnormal foetal heart rate patterns, need for operative delivery for foetal distress, neonatal mortality, Apgar scores, admission to NNU, neonatal seizures, and hypoxic encephalopathy. RESULTS: Randomisation achieved good comparability between the two groups. Abnormal FHR patterns were more frequent in the electronic group (54 pc versus 32 pc). Caesarean section rate was not significantly different in the two groups (28 pc versus 24 pc) although slightly higher compared to overall for the unit (18pc). Foetal outcome was also comparable between the two groups. CONCLUSIONS: Asphyxia can be detected with a hand held doppler just as reliably as by the use of electronic monitors and their use should be further evaluated and promoted in obstetric units caring for high risk pregnancies in developing countries with scarce resources.

Adult↗

Randomised controlled trial of day care for hypertension in pregnancy.

Our aim was to assess the effect of the introduction of a day-care unit on the care of women with non-proteinuric hypertension in pregnancy. A randomised controlled trial was carried out on 54 women who presented at 26 weeks of pregnancy or later with non-proteinuric hypertension (systolic blood pressure 150-170 mm Hg and/or diastolic pressure 90-105 mm Hg on two occasions at least 15 min apart). 30 women were allocated to care by the day unit and 24 were managed according to the established practice of their clinicians without access to the day unit (control group). Women in the control group spent on average 4.6 times longer as inpatients (difference in mean stay 4.0 days [95% confidence interval 2.1-5.9 days]) than the day-unit group and were 8.8 times (95% CI 3.0-25.8) more likely to be admitted to hospital. Induction of labour was 4.9 times (95% CI 1.6-13.8) more likely in the control than in the day-unit group and the development of proteinuria 11.4 times (95% CI 1.8-71.4) more likely. The control group had a mean of 1.5 fewer hospital outpatient visits (95% CI 0.36-2.64). The groups did not differ in their use of antihypertensive drugs. Day-unit care for hypertension in pregnancy significantly reduced the need for and the length of antenatal inpatient admissions and the number of medical interventions, at the cost of an increase in outpatient attendances. Our results are further evidence that inpatient care does not improve outcomes or prevent the development of proteinuria in this disorder.

Adult↗

Women's experiences of continuity of midwifery care in a randomised controlled trial in Australia.

OBJECTIVE: to compare the experiences of women who received a new model of continuity of midwifery care with those who received standard hospital care during pregnancy, labour, birth and the postnatal period. DESIGN: a randomised controlled trial was conducted. One thousand and eighty-nine women were randomly allocated to either the new model of care, the St George Outreach Maternity Project (STOMP), or standard care. Women completed a postal questionnaire eight to ten weeks after the birth. PARTICIPANTS: women in the trial were of mixed obstetric risk status and more than half the sample were born in a non-English speaking country. FINDINGS: questionnaires were returned from 69% of consenting women. STOMP women were significantly more likely to have talked with their midwives and doctors about their personal preferences for childbirth and more likely to report that they knew enough about aspects of labour and birth, particularly induction of labour, pain relief and caesarean section. Almost 80% of women in the STOMP group experienced continuity of care, that is, one of their team midwives was present, during labour and birth. STOMP women reported a significantly higher 'sense of control during labour and birth'. Sixty-three per cent of STOMP women reported that they 'knew' the midwife who cared for them during labour compared with 21% of control women. In a secondary analysis, women who had a midwife during labour who they felt that they knew, had a significantly higher sense of 'control' and a more positive birth experience compared with women who reported an unknown midwife. Postnatal care elicited the greatest number of negative comments from women in both the STOMP and the control group. CONCLUSION: The reorganisation of maternity services to enable women to receive continuity of care has benefits for women. The benefits of a known labour midwife needs further research.

Australia↗

Smoking cessation intervention in parents of young children: a randomised controlled trial.

OBJECTIVE: To examine whether telephone counselling based on the stages of change component of Transtheoretical model of behaviour change together with educational materials could help non-motivated smoking parents of young children to cease. DESIGN: Randomised controlled trial. SETTING: Hong Kong Special Administrative Region, PR China. PARTICIPANTS: 952 smoker fathers and mothers of Chinese children aged 5 years. INTERVENTION: Participants were randomly allocated into two groups: the intervention group received printed self-help materials and three-session telephone-based smoking cessation counselling delivered by trained counsellors; the control group received printed self-help materials only. A structured questionnaire was used for data collection at baseline and at 1, 3 and 6 month follow up. MAIN OUTCOME MEASURES: The main outcome is 7 day point prevalence quit rate at 6 months (defined as not smoking during the 7 days preceding the 6 month follow up) determined by self reports. Other secondary outcomes were self reported 24 h point prevalence quit rate and self-reported continuous quit rate and bio-chemically validated quit rate at 6 months. RESULTS: A total of 952 smoker fathers and mothers were randomized to the intervention (n = 467) and control (n = 485) groups. Most were daily smokers (92.4%) and the mean number of cigarettes smoked per day was 14.5 (SD = 8.9). By using intention-to-treat analysis, the 7 day point prevalence quit rate at 6 month follow up was significantly greater in the intervention group (15.3%; 68/444) than the control group (7.4%; 34/459) (P < 0.001). The absolute risk reduction was 7.9% (95% confidence interval: 3.78% to 12.01%). The number needed to treat to get one additional smoker to quit was 13 (95% CI: 8-26). The crude odds ratio of quitting was 2.3(95% CI: 1.5-3.5). The adjusted odds ratio was 2.1 (95% CI: 1.4-3.4) (adjusted for age, number of years smoked, and alcohol dependency). CONCLUSION: Proactive telephone counselling is an effective aid to promote smoking cessation among parents of young children.

Child, Preschool↗