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Serotherapy in scorpion envenomation: a randomised controlled trial.

BACKGROUND: Evidence for the benefit of scorpion antivenom, the only specific treatment for scorpion envenomation, is scarce, despite its common use. We did a prospective, randomised, controlled trial to assess the efficacy of routine administration of scorpion antivenom to scorpion-stung patients, irrespective of clinical severity. METHODS: We included 825 consecutive patients older than 10 years, who presented to the accident and emergency department of the hospital in Tozeur, Tunisia. We graded severity by absence (grade I) or presence (grade II) of systemic manifestations of scorpion envenomation. Patients were randomly assigned placebo (n=413) or 20 mL bivalent intraveneous scorpion antivenom (n=412). All patients were observed for 4 h. Patients who developed life-threatening symptoms were admitted to the intensive-care unit. At the end of 4 h observation we reassessed grade and discharged grade II patients and admitted grade II patients. We assessed the preventive and curative effects of scorpion antivenom by prevention of worsening grade or by improvement from grade II to grade I. FINDINGS: Distribution of severity grades was similar in the two groups at baseline, as were the cure rates (55% scorpion antivenom, 66% placebo, absolute difference, 11% [95% CI -4.8 to 26.8]; p=0.234). Preventive effects were seen in 94% and 96% of patients in the scorpion antivenom and placebo groups, respectively, who were initially grade I and who remained symptom-free (absolute difference, 2% [-1.27 to 5.27]; p=0.377). Time from scorpion sting to administration of scorpion antivenom did not affect curative and preventive effects. INTERPRETATION: We found no benefit in routine administration of scorpion antivenom after scorpion sting, irrespective of clinical severity. Future studies should focus on patients with the most severe symptoms and signs.

Adolescent↗

The effect of orthodontic referral guidelines: a randomised controlled trial.

OBJECTIVE: To develop and evaluate the effectiveness of referral guidelines for the referral of orthodontic patients to consultant and specialist practitioner orthodontists. DESIGN: Single centre randomised controlled trial with random allocation of referral guidelines for orthodontic treatment to general dental practitioners. SETTING: Hospital orthodontic departments and specialist orthodontic practices in Manchester and Stockport. SUBJECTS: General dental practitioners and the patients they referred for orthodontic treatment. MAIN OUTCOME MEASURE: Appropriateness of referral, defined as whether the patient was accepted for orthodontic treatment. RESULTS: The referral guidelines did not reduce the number of inappropriate referrals. CONCLUSIONS: Referral guidelines for orthodontic referrals did not influence the behaviour of the general dental practitioners. More research into the optimum methods of dissemination and implementation of referral guidelines for use in the general dental service is needed.

Adolescent↗

Role of home visiting in improving parenting and health in families at risk of abuse and neglect: results of a multicentre randomised controlled trial and economic evaluation.

OBJECTIVES: To evaluate the effectiveness and cost effectiveness of an intensive home visiting programme in improving outcomes for vulnerable families. DESIGN: Multicentre randomised controlled trial in which eligible women were allocated to receive home visiting (n = 67) or standard services (n = 64). Incremental cost analysis. SETTING: 40 general practitioner practices across 2 counties in the UK. PARTICIPANTS: 131 vulnerable pregnant women. INTERVENTION: Selected health visitors were trained in the Family Partnership Model to provide a weekly home visiting service from 6 months antenatally to 12 months postnatally. MAIN OUTCOME MEASURES: Mother-child interaction, maternal psychological health attitudes and behaviour, infant functioning and development, and risk of neglect or abuse. RESULTS: At 12 months, differences favouring the home-visited group were observed on an independent assessment of maternal sensitivity (p<0.04) and infant cooperativeness (p<0.02). No differences were identified on any other measures. A non-significant increase in the likelihood of intervention group infants being the subject of child protection proceedings, or being removed from the home, and one death in the control group were found. The mean incremental cost per infant of the home visiting intervention was 3246 pounds sterling (bootstrapped 95% CI for the difference 1645-4803 pounds sterling). CONCLUSION: This intervention may have the potential to improve parenting and increase the identification of infants at risk of abuse and neglect in vulnerable families. Further investigation is needed, along with long-term follow-up to assess possible sleeper effects.

Adolescent↗

Randomised controlled trial of routine hospital clinic care versus routine general practice care for type II diabetics.

Two hundred patients with type II diabetes were entered into a randomised controlled trial lasting five years to compare routine care of this condition by a hospital diabetic clinic with routine care in general practice. Fewer patients in the group being cared for by their general practitioner (general practice group) were regularly reviewed or had regular estimations of blood glucose concentration. More patients in the general practice group than in the hospital group were admitted to hospital for medical reasons during the study (25 (24%) compared with 17 (18%] and more patients in the general practice group died (18) than did in the hospital group (6). At the end of the study mean concentrations of haemoglobin A1 were higher in the general practice group (10.4%) than in the hospital group (9.5%). Routine care in general practice for patients with type II diabetes was less satisfactory than care by the hospital diabetic clinic.

Adult↗

Advising parents of asthmatic children on passive smoking: randomised controlled trial.

OBJECTIVE: To investigate whether parents of asthmatic children would stop smoking or alter their smoking habits to protect their children from environmental tobacco smoke. DESIGN: Randomised controlled trial. SETTING: Tayside and Fife, Scotland. PARTICIPANTS: 501 families with an asthmatic child aged 2-12 years living with a parent who smoked. INTERVENTION: Parents were told about the impact of passive smoking on asthma and were advised to stop smoking or change their smoking habits to protect their child's health. MAIN OUTCOME MEASURES: Salivary cotinine concentrations in children, and changes in reported smoking habits of the parents 1 year after the intervention. RESULTS: At the second visit, about 1 year after the baseline visit, a small decrease in salivary cotinine concentrations was found in both groups of children: the mean decrease in the intervention group (0.70 ng/ml) was slightly smaller than that of the control group (0.88 ng/ml), but the net difference of 0.19 ng/ml had a wide 95% confidence interval (-0.86 to 0.48). Overall, 98% of parents in both groups still smoked at follow up. However, there was a non-significant tendency for parents in the intervention group to report smoking more at follow up and to having a reduced desire to stop smoking. CONCLUSIONS: A brief intervention to advise parents of asthmatic children about the risks from passive smoking was ineffective in reducing their children's exposure to environmental tobacco smoke. The intervention may have made some parents less inclined to stop smoking. If a clinician believes that a child's health is being affected by parental smoking, the parent's smoking needs to be addressed as a separate issue from the child's health.

Adult↗

Domiciliary occupational therapy for patients with stroke discharged from hospital: randomised controlled trial.

OBJECTIVE: To establish if a brief programme of domiciliary occupational therapy could improve the recovery of patients with stroke discharged from hospital. DESIGN: Single blind randomised controlled trial. SETTING: Two hospital sites within a UK teaching hospital. SUBJECTS: 138 patients with stroke with a definite plan for discharge home from hospital. INTERVENTION: Six week domiciliary occupational therapy or routine follow up. MAIN OUTCOME MEASURES: Nottingham extended activities of daily living score and "global outcome" (deterioration according to the Barthel activities of daily living index, or death). RESULTS: By eight weeks the mean Nottingham extended activities of daily living score in the intervention group was 4.8 points (95% confidence interval -0.5 to 10.0, P=0.08) greater than that of the control group. Overall, 16 (24%) intervention patients had a poor global outcome compared with 30 (42%) control patients (odds ratio 0.43, 0.21 to 0.89, P=0.02). These patterns persisted at six months but were not statistically significant. Patients in the intervention group were more likely to report satisfaction with a range of aspects of services. CONCLUSION: The functional outcome and satisfaction of patients with stroke can be improved by a brief occupational therapy programme carried out in the patient's home immediately after discharge. Major benefits may not, however, be sustained.

Activities of Daily Living↗

Preventing childhood obesity by reducing consumption of carbonated drinks: cluster randomised controlled trial.

OBJECTIVE: To determine if a school based educational programme aimed at reducing consumption of carbonated drinks can prevent excessive weight gain in children. DESIGN: Cluster randomised controlled trial. SETTING: Six primary schools in southwest England. PARTICIPANTS: 644 children aged 7-11 years. INTERVENTION: Focused educational programme on nutrition over one school year. MAIN OUTCOME MEASURES: Drink consumption and number of overweight and obese children. RESULTS: Consumption of carbonated drinks over three days decreased by 0.6 glasses (average glass size 250 ml) in the intervention group but increased by 0.2 glasses in the control group (mean difference 0.7, 95% confidence interval 0.1 to 1.3). At 12 months the percentage of overweight and obese children increased in the control group by 7.5%, compared with a decrease in the intervention group of 0.2% (mean difference 7.7%, 2.2% to 13.1%). CONCLUSION: A targeted, school based education programme produced a modest reduction in the number of carbonated drinks consumed, which was associated with a reduction in the number of overweight and obese children.

Body Mass Index↗

Effectiveness of a multiple intervention to reduce antibiotic prescribing for respiratory tract symptoms in primary care: randomised controlled trial.

OBJECTIVES: To assess the effectiveness of a multiple intervention aimed at reducing antibiotic prescription rates for symptoms of the respiratory tract in primary care. DESIGN: Randomised controlled trial. SUBJECTS: Twelve peer review groups including 100 general practitioners with their collaborating pharmacists in the region of Utrecht, Netherlands. INTERVENTION: The intervention consisted of group education meetings, with a consensus procedure on indication for and type of antibiotics and with training in communication skills; monitoring and feedback on prescribing behaviour; group education for assistants of general practitioners and pharmacists; and education material for patients. The control group did not receive any of these elements. MAIN OUTCOME MEASURES: Antibiotic prescription rates for acute symptoms of the respiratory tract and patients' satisfaction. RESULTS: 89 general practitioners completed the study (89%). At baseline, prescription rates for antibiotics for respiratory tract symptoms did not differ between intervention and control group (27% v 29%, respectively). After nine months, the prescription rates in the intervention group fell to 23%, whereas the control group's rose to 37% (mean difference in change -12%, 95% confidence interval -18.9% to -4.0%). Multilevel analysis confirmed the results of the unadjusted analysis (intervention effect -10.7%, -20.3% to -1.0%). Patients' satisfaction was high and did not differ in the two groups at baseline or after the intervention. CONCLUSIONS: A multiple intervention reduced prescribing rates of antibiotics for respiratory tract symptoms while maintaining a high degree of satisfaction among patients. Further research should focus on the sustainability and cost effectiveness of this intervention.

Adult↗

Re-engineering systems for the treatment of depression in primary care: cluster randomised controlled trial.

OBJECTIVE: To test the effectiveness of an evidence based model for management of depression in primary care with support from quality improvement resources. DESIGN: Cluster randomised controlled trial. SETTING: Five healthcare organisations in the United States and 60 affiliated practices. PATIENTS: 405 patients, aged > or = 18 years, starting or changing treatment for depression. INTERVENTION: Care provided by clinicians, with staff providing telephone support under supervision from a psychiatrist. MAIN OUTCOME MEASURES: Severity of depression at three and six months (Hopkins symptom checklist-20): response to treatment (> or = 50% decrease in scores) and remission (score of < 0.5). RESULTS: At six months, 60% (106 of 177) of patients in intervention practices had responded to treatment compared with 47% (68 of 146) of patients in usual care practices (P = 0.02). At six months, 37% of intervention patients showed remission compared with 27% for usual care patients (P = 0.014). 90% of intervention patients rated their depression care as good or excellent at six months compared with 75% of usual care patients (P = 0.0003). CONCLUSION: Resources such as quality improvement programmes can be used effectively in primary care to implement evidence based management of depression and improve outcomes for patients with depression.

Adult↗

Randomised controlled trial of an occupational therapy intervention to increase outdoor mobility after stroke.

OBJECTIVE: To evaluate an occupational therapy intervention to improve outdoor mobility after stroke. DESIGN: Randomised controlled trial. SETTING: General practice registers, social services departments, a primary care rehabilitation service, and a geriatric day hospital. PARTICIPANTS: 168 community dwelling people with a clinical diagnosis of stroke in previous 36 months: 86 were allocated to the intervention group and 82 to the control group. INTERVENTIONS: Leaflets describing local transport services for disabled people (control group) and leaflets with assessment and up to seven intervention sessions by an occupational therapist (intervention group). MAIN OUTCOME MEASURES: Responses to postal questionnaires at four and 10 months: primary outcome measure was response to whether participant got out of the house as much as he or she would like, and secondary outcome measures were response to how many journeys outdoors had been made in the past month and scores on the Nottingham extended activities of daily living scale, Nottingham leisure questionnaire, and general health questionnaire. RESULTS: Participants in the treatment group were more likely to get out of the house as often as they wanted at both four months (relative risk 1.72, 95% confidence interval 1.25 to 2.37) and 10 months (1.74, 1.24 to 2.44). The treatment group reported more journeys outdoors in the month before assessment at both four months (median 37 in intervention group, 14 in control group: P < 0.01) and 10 months (median 42 in intervention group, 14 in control group: P < 0.01). At four months the mobility scores on the Nottingham extended activities of daily living scale were significantly higher in the intervention group, but there were no significant differences in the other secondary outcomes. No significant differences were observed in these measures at 10 months. CONCLUSION: A targeted occupational therapy intervention at home increases outdoor mobility in people after stroke.

Activities of Daily Living↗

Role of multivitamins and mineral supplements in preventing infections in elderly people: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To evaluate the effectiveness of multivitamins and mineral supplements in reducing infections in an elderly population. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Medline and other databases. Reference lists of identified articles were inspected for further relevant articles. SELECTION OF STUDIES: Trials were included if they evaluated the effect of multivitamins and mineral supplements on infections in an elderly population. REVIEW METHODS: Studies were assessed for the methodological quality by using the Jadad instrument. If the data required for the analyses were not available from the published articles we requested them from the original study authors. Meta-analysis was undertaken on three outcomes: the mean difference in number of days spent with infection, the odds ratio of at least one infection in the study period, and the incidence rate ratio for the difference in infection rates. Data on adverse events were also extracted. RESULTS: Eight trials met our inclusion criteria. Owing to inconsistency in the outcomes reported, only a proportion of the trials could be included in each meta-analysis. Multivitamins and mineral supplements were found to reduce the mean annual number of days spent with infection (three studies) by 17.5 (95% confidence interval 11 to 24, P < 0.001). The odds ratio for at least one infection in the study period (three studies) was 1.10 (0.81 to 1.50, P = 0.53). The infection rate ratio (four studies) was 0.89 (0.78 to 1.03, P = 0.11). Reporting of adverse events was poor. CONCLUSION: The evidence for routine use of multivitamin and mineral supplements to reduce infections in elderly people is weak and conflicting. Study results are heterogeneous, and this is partially confounded by outcome measure.

Aged↗

Effect of beta radiation on success of glaucoma drainage surgery in South Africa: randomised controlled trial.

OBJECTIVE: To evaluate whether beta radiation may offer a practical method of improving surgical success for glaucoma drainage surgery in South Africa. DESIGN: Double blind, randomised controlled trial. SETTING: Three public hospitals in South Africa. PARTICIPANTS: 450 black Africans with primary glaucoma. INTERVENTIONS: Trabeculectomy with 1000 cGy beta radiation or standard trabeculectomy without beta radiation (placebo). MAIN OUTCOME MEASURES: Primary outcome measure was surgical failure within 12 months (intraocular pressure > 21 mm Hg while receiving no treatment for ocular hypotension). Secondary outcomes were visual acuity, surgical reintervention for cataract, and intraoperative and postoperative complications. RESULTS: 320 people were recruited. beta radiation was given to 164; 20 (6%) were not seen again after surgery. One year after surgery the estimated risk of surgical failure was 30% (95% confidence interval 22% to 38%) in the placebo arm compared with 5% (2% to 10%) in the radiation arm. The radiation group experienced a higher incidence of operable cataract (18 participants) than the placebo group (five participants; P = 0.01). At two years the estimated risks with placebo and beta radiation were, respectively, 2.8% (0.9% to 8.3%) and 16.7% (10.0% to 27.3%). CONCLUSION: beta radiation substantially reduced the risk of surgical failure after glaucoma surgery. Some evidence was, however, found of an increased risk for cataract surgery (a known complication of trabeculectomy) in the beta radiation arm during the two years after surgery. TRIAL REGISTRATION: ISRCTN62430622 [controlled-trials.com].

Adult↗

Injury prevention training: a cluster randomised controlled trial assessing its effect on the knowledge, attitudes, and practices of midwives and health visitors.

OBJECTIVE: To evaluate the effectiveness of injury prevention training. DESIGN: Cluster randomised controlled trial. SETTING: Primary care facilities in the East Midlands area of the United Kingdom. SUBJECTS: Midwives and health visitors. INTERVENTION: Evidence based training session on the risks associated with baby walkers. MAIN OUTCOME MEASURES: The primary outcome measures were knowledge of baby walker use and walker related injury, attitudes towards walkers and towards walker education, and practices relating to walker health education. RESULTS: Trained midwives and health visitors had greater knowledge of the risks associated with baby walkers than untrained midwives and health visitors (difference between the means 0.22; 95% confidence interval (CI) 0.12 to 0.33). Trained health visitors had more negative attitudes to baby walkers (difference between the means 0.35; 95% CI 0.10 to 0.59) and more positive attitudes towards baby walker health education (difference between the means 0.31; 95% CI 0.00 to 0.62) than untrained health visitors. Midwives who had been trained were more likely to discuss baby walkers in the antenatal period than those who were not trained (odds ratio 9.92; 95% CI 2.02 to 48.83). CONCLUSIONS: Injury prevention training was associated with increased knowledge, more negative attitudes towards walkers, and more positive attitudes towards walker education. Trained midwives were more likely to give advice antenatally. Training did not impact on other practices. Larger trials are required to assess the impact of training on parental safety behaviours, the adoption of safety practices, and injury reduction.

Attitude of Health Personnel↗

Postnatal support for mothers living in disadvantaged inner city areas: a randomised controlled trial.

STUDY OBJECTIVE: To evaluate the effect of two forms of postnatal social support for disadvantaged inner city mothers on maternal and child health outcomes. DESIGN: Randomised controlled trial with economic and process evaluations and follow up at 12 and 18 months. The two intervention groups received either the offer of a year of monthly supportive listening home visits by a support health visitor (SHV), or a year of support from community groups providing drop in sessions, home visiting and/or telephone support (CGS). Each was compared with a control group that received standard health visitor services. SETTING: Two disadvantaged boroughs of London, United Kingdom. PARTICIPANTS: 731 women from culturally diverse backgrounds with infants. MAIN RESULTS: At 12 and 18 months, there was little impact for either intervention on the main outcomes: child injury (SHV: relative risk 0.99; 95% confidence intervals 0.68 to 1.45, CGS: 0.91; 0.61 to1.36), maternal smoking (SHV: 0.86; 0.62 to 1.19, CGS: 0.97; 0.72 to 1.33) or maternal depression (SHV: 0.86; 0.62 to1.19, CGS: 0.93; 0.69 to 1.27). SHV women had different patterns of health service use (with fewer taking their children to the GP) and had less anxious experiences of motherhood than control women. User satisfaction with the SHV intervention was high. Uptake of the CGS intervention was low: 19%, compared with 94% for the SHV intervention. CONCLUSIONS: There was no evidence of impact on the primary outcomes of either intervention among this culturally diverse population. The SHV intervention was associated with improvement in some of the secondary outcomes.

Adult↗

Acyclovir for treating varicella in otherwise healthy children and adolescents: a systematic review of randomised controlled trials.

BACKGROUND: Acyclovir has the potential to shorten the course of chickenpox which may result in reduced costs and morbidity. We conducted a systematic review of randomised controlled trials that evaluated acyclovir for the treatment of chickenpox in otherwise healthy children. METHODS: MEDLINE, EMBASE, and the Cochrane Library were searched. The reference lists of relevant articles were examined and primary authors and Glaxo Wellcome were contacted to identify additional trials. Two reviewers independently screened studies for inclusion, assessed study quality using the Jadad scale and allocation concealment, and extracted data. Continuous data were converted to a weighted mean difference (WMD). Overall estimates were not calculated due to differences in the age groups studied. RESULTS: Three studies were included. Methodological quality was 3 (n = 2) and 4 (n = 1) on the Jadad scale. Acyclovir was associated with a significant reduction in the number of days with fever, from -1.0 (95% CI -1.5,-0.5) to -1.3 (95% CI -2.0,-0.6). Results were inconsistent with respect to the number of days to no new lesions, the maximum number of lesions and relief of pruritus. There were no clinically important differences between acyclovir and placebo with respect to complications or adverse effects. CONCLUSION: Acyclovir appears to be effective in reducing the number of days with fever among otherwise healthy children with chickenpox. The results were inconsistent with respect to the number of days to no new lesions, the maximum number of lesions and the relief of itchiness. The clinical importance of acyclovir treatment in otherwise healthy children remains controversial.

Acyclovir↗

Crisis card following self-harm: 12-month follow-up of a randomised controlled trial.

No intervention has been shown to be effective in preventing repetition of self-harm. In the 6-month follow-up of a large randomised controlled trial, we previously reported no effectiveness of the provision of a card offering 24-h crisis telephone consultation on repetition of self-harm. However, there was a possible benefit among those presenting following a first episode (OR=0.64, 95% CI 0.34-1.22). Here we report the 12-month follow-up of the trial. The results confirm no overall benefit of the intervention (OR=1.19, 95% CI 0.85-1.67). Among those with a first episode of self-harm, the possible benefit of the intervention had diminished (OR=0.89, 95% CI 0.52-1.52), although a modest effect cannot be excluded.

Crisis Intervention↗

Costs and benefits of a one stop clinic compared with a dedicated breast clinic: randomised controlled trial.

OBJECTIVE: To determine the cost to the NHS and the impact on anxiety of a one stop clinic for assessing women with suspected breast cancer. STUDY DESIGN: Randomised controlled trial. PARTICIPANTS: Women aged 35 or over referred with a breast lump. STUDY SETTING: Teaching hospital, north west England. INTERVENTIONS: Women were randomly allocated to attend a one stop clinic or a dedicated breast clinic. OUTCOME MEASURES: Reduction in mean anxiety from baseline at 24 hours after the first visit and at 3 weeks and 3 months after diagnosis; mean cost per patient. RESULTS: 670 women were randomised. Compared with women who attended the dedicated clinic, patients attending the one stop clinic were less anxious 24 hours after the visit (adjusted mean change in state anxiety _5.7 (95% confidence interval _8.4 to _3.0)) but not at 3 weeks or 3 months after diagnosis. The additional cost to the NHS of a one stop attendance was pound 32 per woman; this was largely explained by greater cytopathological and radiological staff costs. CONCLUSION: One stop clinics may not be justified in terms of a reduction in short term anxiety.

Adult↗

Randomised controlled trial of home based care of patients with chronic obstructive pulmonary disease.

OBJECTIVES: To evaluate usefulness of limited community based care for patients with chronic obstructive pulmonary disease after discharge from hospital. DESIGN: Randomised controlled trial. SETTING: Liverpool Health Service and Macarthur Health Service in outer metropolitan Sydney between September 1999 and July 2000. PARTICIPANTS: 177 patients randomised into an intervention group (84 patients) and a control group (93 patients) which received current usual care. INTERVENTIONS: Home visits by community nurse at one and four weeks after discharge and preventive general practitioner care. MAIN OUTCOME MEASURES: Frequency of patients' presentation and admission to hospital; changes in patients' disease-specific quality of life, measured with St George's respiratory questionnaire, over three months after discharge; patients' knowledge of illness, self management, and satisfaction with care at discharge and three months later; frequency of general practitioner and nurse visits and their satisfaction with care. RESULTS: Intervention and control groups showed no differences in presentation or admission to hospital or in overall functional status. However, the intervention group improved their activity scores and the control group worsened their symptom scores. While intervention group patients received more visits from community nurses and were more satisfied with their care, involvement of general practitioners was much less (with only 31% (22) remembering receiving a care plan). Patients in the intervention group had higher knowledge scores and were more satisfied. There were no differences in general practitioner visits or management. CONCLUSIONS: This brief intervention after acute care improved patients' knowledge and some aspects of quality of life. However, it failed to prevent presentation and readmission to hospital.

Adult↗