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PubMedDate not supplied

Screening and referral for brief intervention of alcohol-misusing patients in an emergency department: a pragmatic randomised controlled trial.

BACKGROUND: Alcohol misuse is highly prevalent among people attending emergency departments, but the effect of intervention by staff working in these departments is unclear. We investigated the effect of screening and referral of patients found to be misusing alcohol while attending an emergency department. METHODS: We undertook a single-blind pragmatic randomised controlled trial. Patients received either an information leaflet or an information leaflet plus an appointment with an alcohol health worker. Outcome data were collected by patient interview and examination of hospital records at 6 and 12 months. FINDINGS: 599 patients were randomised over a 12-month period. At 6 months, those referred to an alcohol health worker were consuming a mean of 59.7 units of alcohol per week compared with 83.1 units in the control group (t -2.4, p=0.02). At 12 months those referred were drinking 57.2 units per week compared with 70.8 in controls (t -1.7, p=0.09). Those referred to the alcohol health worker had a mean of 0.5 fewer visits to the emergency department over the following 12 months (1.2 compared with 1.7, t -2.0, p=0.046). Differences in quality of life were not found. INTERPRETATION: Opportunistic identification and referral for alcohol misuse in an emergency department is feasible, associated with lower levels of alcohol consumption over the following 6 months, and reduces reattendance at the department. Short-term reductions in alcohol consumption associated with referral for brief intervention for alcohol misuse benefit patients and reduce demand for accident and emergency department services.

Adult↗

PubMed2003

A randomised controlled trial comparing the Cavaterm endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding.

OBJECTIVE: To compare the effectiveness of the Cavaterm thermal balloon endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding. DESIGN: Randomised controlled trial. SETTING: Minimal access gynaecological surgery unit in a district general hospital. POPULATION: Seventy-two women with dysfunctional uterine bleeding requesting conservative surgical management of their condition. METHODS: Women with a normal endometrial biopsy and normal uterine cavity were randomly allocated to endometrial ablation by Cavaterm or Nd:YAG laser. Patients completed pre-operative and 6- and 12-month post-operative questionnaires assessing menstrual symptoms, quality of life, sexual activity and procedural satisfaction and acceptability. All patients received a single dose of gonadotropin-releasing hormone analogue one month pre-operatively and kept blinded to the procedure performed until after the 6-month assessment. MAIN OUTCOME MEASURES: The primary outcome measure was amenorrhoea rate. Secondary outcomes were effect on blood loss, quality of life, sexual activity, patient satisfaction and procedure acceptability. RESULTS: Seventy-two women were randomised. Amenorrhoea rates at 12 months in the Cavaterm and endometrial laser ablation groups were 29% vs 39% (P = 0.286), with combined amenorrhoea and hypomenorrhoea rates of 73% vs 69%, respectively. At 12 months, repeat surgery rates were higher in the endometrial laser ablation group (15% vs 12%, P = 0.395). Cavaterm was an acceptable procedure and 93% of patients satisfied or very satisfied at 12 months (95% endometrial laser ablation). Both treatments were associated with an increase from baseline in the SF-12 physical score (Cavaterm mean difference -3.9, 95% CI -7.9, 0.2, ns; endometrial laser ablation mean difference -5.1, 95% CI -9.5, -0.7, P = 0.003) and mental health score (Cavaterm mean difference -5.6, 95% CI -9.9, -1.3, P = 0.001; endometrial laser ablation mean difference -5.9, 95% CI -11.7, -0.2, P = 0.04). Patient's own assessment of health (EQ-5D VAS) improved from baseline in both groups (Cavaterm mean difference -7.6, 95% CI -13.9, -1.3, P = 0.02; endometrial laser ablation mean difference -5.4, 95% CI -14.9, 4.2, ns). EQ-5D index scores also improved (Cavaterm mean difference -0.06, 95% CI -0.2, 0.005, ns; endometrial laser ablation mean difference -0.17, 95% CI -0.3, -0.02, P = 0.02). There were no major complications in either group. CONCLUSIONS: The results with the Cavaterm thermal balloon endometrial ablation system are as good as those obtained with the Nd:YAG laser when used for the treatment of dysfunctional uterine bleeding in the short term. It results in a significant reduction in menstrual blood loss, patient satisfaction and improvement in patient quality of life. Larger studies with longer follow up are required to determine its place in the modern treatment of dysfunctional uterine bleeding.

Adult↗

PubMed2004

Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour.

OBJECTIVES: To evaluate the impact of labouring in water during first stage of labour on rates of epidural analgesia and operative delivery in nulliparous women with dystocia. DESIGN: Randomised controlled trial. SETTING: University teaching hospital in southern England. PARTICIPANTS: 99 nulliparous women with dystocia (cervical dilation rate < 1 cm/hour in active labour) at low risk of complications. Interventions Immersion in water in birth pool or standard augmentation for dystocia (amniotomy and intravenous oxytocin). MAIN OUTCOME MEASURES: Primary: epidural analgesia and operative delivery rates. Secondary: augmentation rates with amniotomy and oxytocin, length of labour, maternal and neonatal morbidity including infections, maternal pain score, and maternal satisfaction with care. RESULTS: Women randomised to immersion in water had a lower rate of epidural analgesia than women allocated to augmentation (47% v 66%, relative risk 0.71 (95% confidence interval 0.49 to 1.01), number needed to treat for benefit (NNT) 5). They showed no difference in rates of operative delivery (49% v 50%, 0.98 (0.65 to 1.47), NNT 98), but significantly fewer received augmentation (71% v 96%, 0.74 (0.59 to 0.88), NNT 4) or any form of obstetric intervention (amniotomy, oxytocin, epidural, or operative delivery) (80% v 98%, 0.81 (0.67 to 0.92), NNT 5). More neonates of women in the water group were admitted to the neonatal unit (6 v 0, P = 0.013), but there was no difference in Apgar score, infection rates, or umbilical cord pH. CONCLUSIONS: Labouring in water under midwifery care may be an option for slow progress in labour, reducing the need for obstetric intervention, and offering an alternative pain management strategy.

Analgesia, Epidural↗

PubMed2004

A randomised controlled trial to compare a nurse practitioner to medical staff in the preparation of patients for diagnostic cardiac catheterisation: the study of nursing intervention in practice (SNIP).

BACKGROUND: A number of initiatives have employed nurses in roles traditionally associated with the medical profession but few have been evaluated in prospective randomised studies. This paper reports the results of a randomised controlled trial to assess the performance of a nurse practitioner (NP), trained to prepare patients for diagnostic cardiac catheterisation. METHODS: Eligible and consenting patients were randomised to preparation by either the NP or junior medical staff (JMS). The safety outcome measure was the rate of in-hospital major adverse clinical events including death, myocardial infarction and emergency bypass coronary surgery. Other outcome measures included rate of minor adverse events, cardiologist assessment of case preparation and presentation, patient satisfaction and duration of pre-admission clinic. RESULTS: From April 1997 to May 1998 a series of 355 patients scheduled for elective, day-case, diagnostic cardiac catheterisation were screened. Of these, 345 patients were eligible for the study. A total of 339 patients consented to participate and were randomised. Major adverse clinical events occurred in 0/175 (0%) patients in the NP group and 2/161 (1.2%) patients in the JMS group. (Risk difference = -1.2%, upper boundary of the 95% confidence interval = +2.0%) The cardiologist's evaluation that the patient's preparation was acceptable was high in both groups: NP group 98.3% vs. JMS group 98.8%: P = 1.0). Patient satisfaction, assessed by questionnaire, was greater in the NP group (P = 0.04). The median duration of the pre-admission clinic visit was lower in the NP group 165 min vs. 185 min in the JMS group, P = 0.01). CONCLUSIONS: The preparation of patients for diagnostic cardiac catheterisation can be safely performed by an appropriately trained NP. This approach may be associated with improved patient satisfaction and reduced clinic duration times.

Cardiac Catheterization↗

PubMed2005

Randomised controlled trial of a lay-led self-management programme for Bangladeshi patients with chronic disease.

BACKGROUND: Reducing the impact of chronic disease in minority ethnic groups is an important public health challenge. Lay-led education may overcome cultural and language barriers that limit the effectiveness of professionally-led programmes. We report the first randomised trial of a lay-led self-management programme - the Chronic Disease Self-Management Programme (CDSMP) (Expert Patient Programme) - in a south Asian group. AIM: To determine the effectiveness of a culturally-adapted lay-led self-management programme for Bangladeshi adults with chronic disease. DESIGN OF STUDY: Randomised controlled trial. SETTING: Tower Hamlets, east London. METHOD: We recruited Bangladeshi adults with diabetes, cardiovascular disease, respiratory disease or arthritis from general practices and randomised them to the CDSMP or waiting-list control. Self-efficacy (primary outcome), self-management behaviour, communication with clinician, depression scores, and healthcare use were assessed by blinded interviewer-administered questionnaires in Sylheti before randomisation and 4 months later. RESULTS: Of the 1363 people invited, 476 (34%) agreed to take part and 92% (439/476) of participants were followed up. The programme improved self-efficacy (difference: 0.67, 95% confidence interval [CI] = 0.08 to 1.25) and self-management behaviour (0.53; 95% CI = 0.01 to 1.06). In the 51% (121/238) of intervention participants attending three or more of the 6-weekly education sessions the programme led to greater improvements in self-efficacy (1.47; 95% CI = 0.50 to 1.82) and self-management behaviour (1.16; 95% CI = 0.50 to 1.82), and reduced HADS depression scores (0.64; 95% CI = 0.07 to 1.22). Communication and healthcare use were not significantly different between groups. The programme cost pound123 (181) per participant. CONCLUSION: A culturally-adapted CDSMP improves self-efficacy and self-care behaviour in Bangladeshi patients with chronic disease. Effects on health status were marginal. Benefits were limited by moderate uptake and attendance.

Adult↗

PubMed1991

Randomised, controlled trial of effectiveness of ampicillin in mild acute respiratory infections in Indonesian children.

The recommended treatment for mild acute respiratory infections (ARI) in children is supportive care only, but many physicians, especially in developing countries, continue to prescribe antibiotic treatment because they believe it prevents progression to more severe ARI. To find out whether ampicillin treatment conferred any benefit over supportive care alone, a randomised, controlled trial was carried out among 889 children (under 5 years) with mild ARI in Indonesia. 447 were randomly allocated ampicillin (25-30 mg/kg body weight three times daily for 5 days) plus supportive care (continued breastfeeding, clearing of the nose, and paracetamol to control fever); 442 were allocated supportive care only. The treatment groups were almost identical after randomisation in terms of age, sex, level of parental education, history of measles immunisation, and fever. After 1 week the percentages cured were nearly identical (204 [46%] ampicillin; 209 [47%] control), as were the percentages of cases progressing to moderate ARI (56 [13%] vs 53 [12%]). The effect of treatment was not modified by age, sex, measles immunisation status, or the educational level of the parents. At the 2-week follow-up, the percentages cured were 62% (277) in the ampicillin group and 58% (256) in the control group; 14% of both groups had progressed to moderate ARI; and 24% (107) and 28% (123), respectively, still had mild ARI. None of the differences in outcome between the ampicillin and control groups was statistically significant. Thus, ampicillin plus supportive care offers no benefit over supportive care alone for treatment of mild ARI in young Indonesian children.

Acute Disease↗

PubMed2004

The effectiveness of pneumococcal polysaccharide vaccines in adults: a systematic review of observational studies and comparison with results from randomised controlled trials.

The use of pneumococcal polysaccharide vaccine has remained controversial since licensure, especially in the elderly. Observational studies form much of the evidence base. We conducted a systematic review of observational studies and compared results with those obtained from an earlier review of randomised controlled trials (RCTs). Estimates of protection against invasive disease from observational studies were consistent, homogenous and compatible with sparse information obtained from RCTs. Studies were of moderate quality. From 13 observational studies the estimate of vaccine efficacy against invasive disease was 53% (46-59%) compared with 38% (-4 to 63%) from nine RCTs. Estimates of protection against all-cause pneumonia were based on fewer, heterogeneous studies that were not consistent with the findings from RCTs for this outcome. From five studies combined efficacy was 32% (7-50%) compared with 3% (-16 to 19%) from 13 RCTs.

Adult↗

PubMed2005

Using dietetic assistants to improve the outcome of hip fracture: a randomised controlled trial of nutritional support in an acute trauma ward.

OBJECTIVE: To examine how improved attention to nutritional status and dietary intake, achieved through the employment of dietetic assistants (DAs), will affect postoperative clinical outcome among elderly women with hip fracture. DESIGN: Open prospective randomised controlled trial, comparing conventional nursing care with the additional nutritional support provided by DA. SETTING: Thirty-eight bedded acute trauma ward in a teaching hospital. PARTICIPANTS: All but 11 of 344 consecutive admissions with acute nonpathological hip fracture were approached. Three hundred and eighteen (93%) agreed to inclusion. Sixteen were ineligible as they were immediately transferred to another acute ward, were managed conservatively or died preoperatively. PRIMARY OUTCOME MEASURE: Postoperative mortality in the acute trauma unit. SECONDARY OUTCOME MEASURES: Postoperative mortality at 4 months after fracture, length of stay, energy intake and nutritional status. RESULTS: DA-supported participants were less likely to die in the acute ward (4.1 versus 10.1%, P = 0.048). This effect was still apparent at 4 month follow-up (13.1 versus 22.9%, P = 0.036). DA-supported subjects had significantly better mean daily energy intake (1,105 kcal versus 756 kcal/24 h, 95% CI 259-440 kcal/24 h, P<0.001), significantly smaller reduction in mid-arm circumference during their inpatient stay (0.39 cm, P = 0.002) and nonsignificantly favourable results for other anthropometric and laboratory measurements. CONCLUSION: Dietetic or nutrition assistants are being introduced in units across the UK. This, the largest ever study of nutritional support after hip fracture, shows that their employment significantly reduced patients' risk of dying in the acute trauma unit; an effect that persisted at 4 month follow-up.

Aged↗

PubMed2000

Randomised controlled trial of an educational strategy to increase school-based adolescent hepatitis B vaccination.

OBJECTIVES: This study aimed to evaluate a specifically designed hepatitis B education/promotion curriculum package as part of a successful hepatitis B vaccination delivery system to adolescents. METHODS: A randomised-controlled trial was used to evaluate the effect of the curriculum package (or intervention) on uptake of vaccine. Schools were randomly selected from the metropolitan region of Melbourne to intervention (66 schools or 7,588 students) or control groups (69 schools or 9,823 students). Class teachers administered the intervention to students over 4 class periods before the vaccination course. RESULTS: The difference in mean school uptake between intervention and control was small at 1-2% per dose. 95% confidence intervals around the differences were -5% to 2% per dose and not significant. Intervention schools taught an average of 7 items out of 12 from the curriculum package. Immunisation rates increased by 4-10% per dose between low and high implementation schools, but this trend was not significant. Impact evaluation demonstrated significantly greater knowledge of hepatitis B and vaccination among students in the intervention than the control group. CONCLUSION: Hepatitis B vaccination of pre-adolescents was not increased by the implementation of a curriculum package that successfully increased knowledge and awareness of hepatitis B in a school-based vaccination program. Additional strategies directed at the education of parents, the cooperative role of schools and pro-active providers might also be required to maximise vaccine uptake in this age group.

Adolescent↗

PubMed1994

Randomised controlled trial of the use of human chorionic gonadotrophin in recurrent miscarriage associated with polycystic ovaries.

OBJECTIVE: To determine whether the use of human chorionic gonadotrophin (hCG) would reduce the recurrent miscarriage rate in women with polycystic ovarian disease. DESIGN: Double-blind, prospective, randomised controlled trial. SETTING: A pregnancy loss clinic in a London teaching hospital. SUBJECTS: One hundred and ninety-one women with a history of three consecutive spontaneous first trimester miscarriages and polycystic ovary syndrome. INTERVENTION: 10,000 i.u. of hCG or a placebo were given when the leading follicle was > or = 21 mm, then 5000 i.u. of hCG or a placebo were given twice weekly until miscarriage or the tenth week of pregnancy. MAIN OUTCOME MEASURE: Miscarriage rate. RESULTS: Women with polycystic ovaries who received hCG treatment had a lower miscarriage rate (14%) compared with women who received placebo (43%). In women with follicular phase luteinising hormone > 10 iu/l, those who received hCG therapy had a miscarriage rate of 10% compared with a rate of 44% in women who received the placebo. When clomiphene was used for ovulation induction, women treated with hCG had a miscarriage rate of 14% compared with a rate 47% in women who received the placebo. There was no significant benefit from hCG therapy in natural cycles. CONCLUSION: The use of hCG in women with recurrent miscarriage and polycystic ovary syndrome improves the pregnancy outcome.

Abortion, Habitual↗

PubMed2001

A comparison of isosorbide mononitrate, misoprostol and combination therapy for first trimester pre-operative cervical ripening: a randomised controlled trial.

OBJECTIVE: To determine whether a combined therapy with isosorbide mononitrate (40mg) and misoprostol (400 microg) for pre-operative cervical ripening in the first trimester would result in improved clinical effectiveness, and fewer side effects compared with each agent used alone. DESIGN: Randomised controlled trial. SETTING: Glasgow Royal Infirmary. POPULATION: Sixty-six primigravid women scheduled for suction termination of pregnancy. METHODS: Women were randomly assigned to receive before surgery, per vaginam, isosorbide mononitrate 40 mg (n = 22), misoprostol 400 microg (n = 22) or both agents together [isosorbide mononitrate 40 mg and misoprostol 400 microg] (n = 22). MAIN OUTCOME MEASURES: 1. To assess the cumulative force required to dilate the cervix to 8 mm; 2. the onset of new symptoms before termination of pregnancy. RESULTS: The cervical resistance following combination therapy with isosorbide mononitrate and misoprostol was not significantly different than following misoprostol alone [24.5N vs 18.5N; median difference (95% CI) 19N (-22 to 49)]. Pre-treatment with misoprostol used alone resulted in a lower cervical resistance than isosorbide mononitrate alone (18.5N vs 39N, P = 0.04, Mann-Whitney U test). There was no difference in the number of women remaining asymptomatic following either isosorbide mononitrate or misoprostol or combination therapy [14/22 (64%) vs 11/21 (52%) vs 11/22 (50%), Fisher's exact test]. CONCLUSIONS: We have not shown any advantage of combining misoprostol with the nitric oxide donor isosorbide mononitrate compared with misoprostol alone for pre-operative cervical ripening in the first trimester.

Abortifacient Agents, Nonsteroidal↗

PubMed1990

A randomised controlled trial of surgery for glue ear.

OBJECTIVE: To assess the effect of five different surgical treatments for glue ear (secretory otitis media) on improvement in hearing and, assuming one or more treatments to be effective, to identify the appropriate indications for surgery. DESIGN: Randomised controlled trial of children receiving (a) adenoidectomy, bilateral myringotomy, and insertion of a unilateral grommet; (b) adenoidectomy, unilateral myringotomy, and insertion of a unilateral grommet; (c) bilateral myringotomy and insertion of a unilateral grommet; and (d) unilateral myringotomy and insertion of a grommet. Children were followed up at seven weeks, six months, 12 months, and 24 months by symptom history and clinical investigations. SETTING: Otolaryngology department in an urban hospital. PATIENTS: 149 Children aged 4-9 years who were admitted for surgery for glue ear and who had no history of previous operations on tonsils, adenoids, or ears and no evidence of sensorineural deafness. Inadequate follow up information on levels of hearing and on middle ear function was obtained from 22. MAIN OUTCOME MEASURES: Mean hearing loss (dB) of the three worst heard frequencies between 250 and 4000 Hz, results of impedance tympanometry, and parental views on their child's progress. RESULTS: In the 127 children for whom adequate information was available ears in which a grommet had been inserted performed better in the short term (for at least six months) than those in which no grommet had been inserted, irrespective of any accompanying procedure. Most of the benefit had disappeared by 12 months. Adenoidectomy produced a slight improvement that was not significant, though was sustained for at least two years. The ears of children who had had an adenoidectomy with myringotomy and grommet insertion, however, continued to improve so that two years after surgery about 50% had abnormal tympanometry compared with 83% of those who had had only myringotomy and grommet insertion, and 93% of the group that had had no treatment. Logistic regression analyses identified preoperative hearing level as the single best predictor of good outcome from surgery. Other variables contributed little additional predictive power. CONCLUSIONS: If the principal objective of surgery for glue ear is to restore hearing then our study shows that insertion of grommets is the treatment of choice. The addition of an adenoidectomy will increase the likelihood of restoration of normal function of the middle ear but will not improve hearing. When deciding appropriate indications for surgery, a balance has to be made between performing unnecessary operations and failing to treat patients who might benefit from surgical intervention. Preoperative audiometry scores might be the best predictor in helping to make this decision.

Acoustic Impedance Tests↗

PubMed2004

Training carers of stroke patients: randomised controlled trial.

BACKGROUND: Informal care givers support disabled stroke patients at home but receive little training for the caregiving role. OBJECTIVE: To evaluate the effectiveness of training care givers in reducing burden of stroke in patients and their care givers. DESIGN: A single, blind, randomised controlled trial. SETTING: Stroke rehabilitation unit. SUBJECTS: 300 stroke patients and their care givers. INTERVENTIONS: Training care givers in basic nursing and facilitation of personal care techniques. MAIN OUTCOME MEASURES: Cost to health and social services, caregiving burden, patients' and care givers' functional status (Barthel index, Frenchay activities index), psychological state (hospital anxiety and depression score), quality of life (EuroQol visual analogue scale) and patients' institutionalisation or mortality at one year. RESULTS: Patients were comparable for age (median 76 years; interquartile range 70-82 years), sex (53% men), and severity of stroke (median Barthel index 8; interquartile range 4-12). The costs of care over one year for patients whose care givers had received training were significantly lower (10,133 pounds sterling v 13,794 pounds sterling (18,087 dollars v 24,619 dollars; 15,204 euros v 20,697 euros); P = 0.001). Trained care givers experienced less caregiving burden (care giver burden score 32 v 41; P = 0.0001), anxiety (anxiety score 3 v 4; P = 0.0001) or depression (depression score 2 v 3; P = 0.0001) and had a higher quality of life (EuroQol score 80 v 70; P = 0.001). Patients' mortality, institutionalisation, and disability were not influenced by caregiver training. However, patients reported less anxiety (3 v 4.5; P < 0.0001) and depression (3 v 4; P < 0.0001) and better quality of life (65 v 60; P = 0.009) in the caregiver training group. CONCLUSION: Training care givers during patients' rehabilitation reduced costs and caregiver burden while improving psychosocial outcomes in care givers and patients at one year.

Aged↗

PubMed1997

London-East Anglia randomised controlled trial of cognitive-behavioural therapy for psychosis. I: effects of the treatment phase.

BACKGROUND: A series of small, mainly uncontrolled, studies have suggested that techniques adapted from cognitive-behavioural therapy (CBT) for depression can improve outcome in psychosis, but no large randomised controlled trial of intensive treatment for medication-resistant symptoms of psychosis has previously been published. METHOD: Sixty participants who each had at least one positive and distressing symptom of psychosis that was medication-resistant were randomly allocated between a CBT and standard care condition (n = 28) and a standard care only control condition (n = 32). Therapy was individualised, and lasted for nine months. Multiple assessments of outcome were used. RESULTS: Over nine months, improvement was significant only in the treatment group, who showed a 25% reduction on the BPRS. No other clinical, symptomatic or functioning measure changed significantly. Participants had a low drop-out rate from therapy (11%), and expressed high levels of satisfaction with treatment (80%). Fifty per cent of the CBT group were treatment responders (one person became worse), compared with 31% of the control group (three people became worse and another committed suicide). CONCLUSIONS: CBT for psychosis can improve overall symptomatology. The findings provide evidence that even a refractory group of clients with a long history of psychosis can engage in talking about psychotic symptoms and their meaning, and this can improve outcome.

Adaptation, Psychological↗

PubMed2002

A pilot randomised controlled trial of peripheral fractional oxygen extraction to guide blood transfusions in preterm infants.

BACKGROUND: Peripheral fractional oxygen extraction (FOE) may be a better indicator of the need for transfusion than the haemoglobin concentration (Hb) because it is a measure of the adequacy of oxygen delivery to meet demand. A randomised controlled trial of the use of peripheral FOE to guide the need for blood transfusions in preterm infants was carried out to test this hypothesis. METHOD: Infants less than 1500 g birth weight who were stable and less than 2 weeks old were randomised to receive transfusions guided by either a conventional protocol based on Hb (conventional group) or a protocol based on measurements of peripheral FOE made by near infrared spectroscopy (NIRS group). Measurements of Hb and FOE were made on all infants from randomisation until discharge. The primary outcome measures were number of transfusions received, rate of weight gain, and postmenstrual age at discharge. RESULTS: Thirty seven infants were randomised to each group. Birth weight (median, range) (1200, 1004-1373 v 1136, 1009-1285 g) and Hb (median, range) at randomisation (160, 149-179 v 155, 145-181 g/l) did not differ between the two groups. The total number of transfusions given to the NIRS group was 56 and to the conventional group 84. The median number of transfusions per infant, the median volume of blood transfused to each group, and the total number of donors to which infants were exposed were similar in the two groups. Infants transfused according to the conventional protocol were more likely to be transfused earlier and at a higher Hb than those transfused in the NIRS group. Infants in the conventional group spent a significantly shorter period than those in the NIRS group with Hb < 100 g/l. Of the 56 transfusions given to the NIRS group, 33 (59%) were given because of clinical concerns rather than because of high FOE. There was no difference in the rate of weight gain, rate of linear growth, postmenstrual age at discharge, or the incidence of chronic lung disease or retinopathy of prematurity. CONCLUSIONS: FOE measurements failed to identify many infants felt by clinicians to require blood transfusion. This may have been because clinicians relied on conventional indicators of transfusion that are vague and non-specific, or a peripheral FOE of 0.47 alone may not be a sensitive enough predictor of the need for transfusion. This requires further study.

Blood Transfusion↗

PubMed2003

A factorial randomised controlled trial of decision analysis and an information video plus leaflet for newly diagnosed hypertensive patients.

BACKGROUND: There is a lack of evidence regarding the value of tools designed to aid decision making in patients with newly diagnosed hypertension. AIM: To evaluate two interventions for assisting newly diagnosed hypertensive patients in the decision whether to start drug therapy for reducing blood pressure. DESIGN OF STUDY: Factorial randomised controlled trial. SETTING: Twenty-one general practices in south-west England, UK. METHOD: Adults aged 32 to 80 years with newly diagnosed hypertension were randomised to receive either: (a) computerised utility assessment interview with individualized risk assessment and decision analysis; or (b) information video and leaflet about high blood pressure; or (c) both interventions; or (d) neither intervention. Outcome measures were decisional conflict, knowledge, state anxiety, intentions regarding starting treatment, and actual treatment decision. RESULTS: Of 217 patients randomised, 212 (98%) were analysed at the primary follow-up (mean age = 59 years, 49% female). Decision analysis patients had lower decisional conflict than those who did not receive this intervention (27.6 versus 38.9, 95% confidence interval [CI] for adjusted difference = -13.0 to -5.8, P < 0.001), greater knowledge about hypertension (73% versus 67%, adjusted 95% CI = 2% to 9%, P = 0.003) and no evidence of increased state anxiety (34.8 versus 36.8, adjusted 95% CI = -5.6 to 0.1, P = 0.055). Video/leaflet patients had lower decisional conflict than corresponding controls (30.3 versus 36.8, adjusted 95% CI = -7.4 to -0.6, P = 0.021), greater knowledge (75% versus 65%, adjusted 95% CI = 6% to 13%, P < 0.001) and no evidence of increased state anxiety (35.7 versus 36.1, adjusted 95% CI = -3.9 to 1.7, P = 0.46). There were no differences between either of the interventions and their respective controls in the proportion of patients prescribed antihypertensive medication (67%). CONCLUSIONS: This trial demonstrates that, among patients facing a real treatment decision, interventions to inform patients about hypertension and to clarify patients' values concerning outcomes of treatment are effective in reducing decisional conflict and increasing patient knowledge, while not resulting in any increases in state anxiety.

Adult↗

PubMed2003

Treating depression in primary care in low-income women in Santiago, Chile: a randomised controlled trial.

BACKGROUND: Depression in women is one of the commonest problems encountered in primary care. We aimed to compare the effectiveness of a stepped-care programme with usual care in primary-care management of depression in low-income women in Santiago, Chile. METHODS: In a randomised controlled trial, in three primary-care clinics in Chile, 240 adult female primary-care patients with major depression were allocated stepped care or usual care. Stepped care was a 3-month, multicomponent intervention led by a non-medical health worker, which included a psychoeducational group intervention, structured and systematic follow-up, and drug treatment for patients with severe depression. Data were analysed on an intention-to-treat basis. The primary outcome measure was the Hamilton depression rating scale (HDRS) administered at baseline and at 3 and 6 months after randomisation. FINDINGS: About 90% of randomised patients completed outcome assessments. There was a substantial between-group difference in all outcome measures in favour of the stepped-care programme. The adjusted difference in mean HDRS score between the groups was -8.89 (95% CI -11.15 to -6.76; p<0.0001). At 6-months' follow-up, 70% (60-79) of the stepped-care compared with 30% (21-40) of the usual-care group had recovered (HDRS score <8). INTERPRETATION: Despite few resources and marked deprivation, women with major depression responded well to a structured, stepped-care treatment programme, which is being introduced across Chile. Socially disadvantaged patients might gain the most from systematic improvements in treatment of depression.

Adult↗

PubMed2005

Supplementation of general endurance exercise with stabilisation training versus general exercise only. Physiological and functional outcomes of a randomised controlled trial of patients with recurrent low back pain.

BACKGROUND: Determination of the mode of action of new exercise techniques in different back pain populations is lacking. The effectiveness of supplementing an exercise programme with stabilisation exercises concerning physiological and functional parameters in non-specific back pain patients is unknown. METHODS: Randomised controlled trial, comparing a general trunk muscle endurance exercise approach enhanced with specific muscle stabilisation exercises (S&G group) with a general exercise approach only (G group). 55 patients with recurrent back pain were randomised in S&G group (n=29) and G group (n=26). Both groups received an 8-week exercise intervention and written advice. Paraspinal muscle strength and electromyographic fatigue of the erector spinae and multifidus were measured. Additionally, 3 functional speed tests were assessed. Outcomes were collected pre- and post-intervention. FINDINGS: No differences were detected for any of the paraspinal fatigue characteristics either within or between groups, apart from a significant decrease in normalised median frequency slope of the erector spinae for the G group. Paraspinal muscle strength and all functional tests have demonstrated significant within-group improvements for both groups, without any between-group differences. INTERPRETATION: An 8-week stabilisation exercise-enhanced approach presented equal benefits to a general endurance-based exercise programme for patients with recurrent non-specific back pain. A slightly steeper slope for the erector spinae in the G group was the only electromyographic fatigue alteration noted. Concomitant strength improvement probably reflects neural input changes rather than histochemical muscle changes. Physical exercise alone and not the exercise type was the key determinant for improvement in this patient group.

Back↗