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Results for “Randomised Controlled Trial”

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PubMed2004

Feasibility of integrating early stimulation into primary care for undernourished Jamaican children: cluster randomised controlled trial.

OBJECTIVES: To assess the feasibility of integrating early psychosocial stimulation into primary care for undernourished children and to determine the effect on children's development and mothers' knowledge and practices of childrearing. DESIGN: Cluster randomised controlled trial. SETTING: 18 clinics in three Jamaican parishes. PARTICIPANTS: 139 undernourished children aged 9 to 30 months and their mothers enrolled in intervention or control clinics. INTERVENTIONS: Weekly home visits by community health aides for one year in addition to usual duties. Parenting issues were discussed with the mothers and play activities were demonstrated with the children using homemade materials. MAIN OUTCOME MEASURES: Children's scores on the Griffiths mental development scales and mothers' knowledge and practices of childrearing measured by questionnaires. RESULTS: Children from the intervention group showed significant improvements in development: developmental quotient, 7.8 points (95% confidence interval 4.5 to 11.1); hearing and speech, 10.7 (5.9 to 15.4 points); hand and eye coordination, 6.8 (3.4 to 10.1 points); and performance subscale, 11.0 (5.6 to 16.4 points). No improvements were shown on the locomotor subscale. The mothers from the intervention group showed improved knowledge and practices of childrearing. Change in children's body mass index and height independently affected change in development. CONCLUSION: Integrating parenting skills and early psychosocial stimulation for undernourished children into primary care was feasible and effective in improving the children's development and mothers' knowledge and practices of childrearing.

Child Development↗

PubMed1999

Prospective single blinded randomised controlled trial of two orally administered activated charcoal preparations.

OBJECTIVES: To compare two activated charcoal preparations (Carbomix and Actidose-Aqua) in terms of amount ingested and incidence of vomiting after ingestion. METHODS: Single blinded prospective randomised controlled trial. RESULTS: The mean amount of charcoal ingested was Carbomix 26.5 g, Actidose-Aqua 19.5 g. The mean difference was 7 g (95% confidence interval (CI) 1.5 to 12.4 g). The incidence of vomiting was for the Carbomix 6% and the Actidose-Aqua 8%. The mean difference in vomiting was 2% (95% CI -0.8 to 4.8) CONCLUSIONS: Carbomix administration results in an increased amount of activated charcoal ingested after oral administration. Rates of vomiting after activated charcoal administration were low when compared with previously reported rates.

Antidotes↗

PubMed2006

Increasing child pedestrian and cyclist visibility: cluster randomised controlled trial.

STUDY OBJECTIVE: Visibility aids have the potential to reduce child pedestrian and cyclist injury but scarce data exist relating to their use or to interventions for increasing visibility aid use among children. This cluster randomised controlled trial was designed to assess the use of free visibility aids one and eight weeks after their provision among primary school children in Nottingham, UK. DESIGN: One class from each of 20 schools representing 377 children aged 7, 8, and 9 years old participated in the trial and were randomly assigned to treatment and control arms. Children in the intervention arm received two visibility aids, namely, a reflective and fluorescent slap wrap (an item that can be worn around an arm or trouser leg and is readily removed), and a reflective durable sticker in addition to educational material on the importance of being seen in the dark. Observers visited schools to observe use of reflective and fluorescent slap wraps, stickers, piping and patches on coats, and bags at baseline and at one and eight weeks after distribution of the visibility aids. The study used random effects logistic regression to calculate odds ratios (OR) and confidence intervals (CI). MAIN RESULT: The results showed that children provided with free visibility aids were significantly more likely to use any visibility aid at one week (adjusted OR 59.5, 95% CI 18.5 to 191.0) and eight weeks (adjusted OR 5.9, 95% CI 3.4 to 10.4) after distribution than children in the control arm. CONCLUSIONS: Providing free visibility aids and an educational booklet on road safety significantly increases use of visibility aids for up to eight weeks during the winter among primary school children. On the basis of an eight week follow up trial in Nottingham of 20 classes of children aged 7 to 9 years old, these results suggest that campaigns providing free visibility aids to primary school children should be encouraged.

Accident Prevention↗

PubMed1990

A randomised controlled trial of counseling in a workplace setting for coronary heart disease risk factor modification: effects on blood pressure.

This paper reviews a prospective study of occupational factors in coronary heart disease risk incorporated in a randomised controlled trial of a worksite based occupational health nurse counseling program for reducing coronary heart disease risk factors. The aim of the trial was to evaluate the longterm effectiveness of the counseling program in persons with mildly elevated risk factor levels. Of the 2,489 Australian government employees with mildly elevated risk factor levels who entered the intervention trial, 1,937 (78%) attended a followup examination three years later. This paper reports on changes in systolic and diastolic blood pressure. Multiple linear regression models were used with three-year blood pressure reduction as the dependent variable, intervention status as the main determinant, and sex, age, initial risk level and initial blood pressure as covariates. Although systolic and diastolic blood pressure fell in both the intervention and control groups, intervention was significantly associated with systolic blood pressure change only.

Adult↗

PubMed2006

Effectiveness and costs of acute day hospital treatment compared with conventional in-patient care: randomised controlled trial.

BACKGROUND: Data on effectiveness of acute day hospital treatment for psychiatric illness are inconsistent. AIMS: To establish the effectiveness and costs of care in a day hospital providing acute treatment exclusively. METHOD: In a randomised controlled trial, 206 voluntarily admitted patients were allocated to either day hospital treatment or conventional wards. Psychopathology, treatment satisfaction and subjective quality of life at discharge, 3 months and 12 months after discharge, readmissions to acute psychiatric treatment within 3 and 12 months, and costs in the index treatment period were taken as outcome criteria. RESULTS: Day hospital patients showed significantly more favourable changes in psychopathology at discharge but not at follow-up. They also reported higher treatment satisfaction at discharge and after 3 months, but not after 12 months. There were no significant differences in subjective quality of life or in readmissions during follow-up. Mean total support costs were higher for the day hospital group. CONCLUSIONS: Day hospital treatment for voluntary psychiatric patients in an inner-city area appears more effective in terms of reducing psychopathology in the shortterm and generates greater patient satisfaction than conventional in-patient care, but may be more costly.

Adult↗

PubMed2004

VenUS I: a randomised controlled trial of two types of bandage for treating venous leg ulcers.

OBJECTIVES: To compare the clinical and cost-effectiveness of two different compression bandages for the healing of venous leg ulcers. DESIGN: A pragmatic, randomised controlled trial with an economic evaluation. SETTING: Community, district nurse-led services; community leg ulcer clinics; hospital leg ulcer clinics with community outreach. A range of urban and rural settings in England and Scotland. PARTICIPANTS: Patients with a venous leg ulcer of at least 1-week's duration, at least 1 cm in length or width and an ankle:brachial pressure index of at least 0.8. INTERVENTIONS: The four-layer bandage (4LB) (which is multilayer elastic compression) compared with the short-stretch bandage (SSB) (multilayer, inelastic compression). MAIN OUTCOME MEASURES: The primary end-point was complete healing of all the ulcers on the trial leg. Secondary outcomes were the proportion of patients healed at 12 and 24 weeks, rate of recurrence, costs of leg ulcer treatment and quality of life. RESULTS: Between April 1999 and December 2000 the trial recruited 387 people aged from 23 to 97 years at trial entry. The majority of patients in this trial (82%; 316/387) had a reference ulcer of area </=10 cm(2). To test the difference over time of Kaplan--Meier curves for the two bandage groups, the distribution of the cumulative times to healing of individuals in the two trial groups was compared using the log-rank test. The difference in the distribution of cumulative healing times between the individuals in the two groups was not statistically significant at the 5% level. Adjusting for the effects of variables which may influence healing (centre, baseline ulcer area, duration, episodes, ankle mobility, weight) in a Cox proportional hazards model, a statistically significant treatment effect in favour of the 4LB was identified. At any point in time, the probability of healing for individuals in the SSB treatment arm is significantly lower than that for people treated with the 4LB. Our base case economic analysis showed that the 4LB is the dominant strategy, that is, it is associated with a greater health benefit and lower costs than the SSB, although the differences are not statistically significant. This result is explained largely by the greater number of community nurse visits required by participants in the short-stretch arm. CONCLUSIONS: The 4LB, which is currently the UK standard compression bandage for people with venous leg ulcers, was more clinically and cost-effective than the SSB. The bandage costs were less important than the costs of treatment visits, and patients in SSBs required more treatment overall. Generally, this trial supports the use of the 4LB in preference to the SSB. Recommendations for future research include: exploration of the relationship between bandager skill, application technique and ulcer healing; the relative cost-effectiveness of community leg ulcer clinics; and the study of nurse decision-making in venous ulcer management.

Adult↗

PubMed2004

Randomised controlled trial of graded exercise in chronic fatigue syndrome.

OBJECTIVE: To investigate whether 12 weeks of graded exercise with pacing would improve specific physiological, psychological and cognitive functions in people with chronic fatigue syndrome (CFS). DESIGN: Randomised controlled trial. SETTING: Human performance laboratory at the University of Western Australia. PARTICIPANTS: 61 patients aged between 16 and 74 years diagnosed with CFS. INTERVENTIONS: Either graded exercise with pacing (32 patients) or relaxation/flexibility therapy (29 patients) performed twice a day over 12 weeks. MAIN OUTCOME MEASURES: Changes in any of the physiological, psychological or cognitive variables assessed. RESULTS: Following the graded exercise intervention, scores were improved for resting systolic blood pressure (P = 0.018), work capacity (W.kg(-1)) (P = 0.019), net blood lactate production (P = 0.036), depression (P = 0.027) and performance on a modified Stroop Colour Word test (P = 0.029). Rating of perceived exertion scores, associated with an exercise test, was lower after graded exercise (P = 0.013). No such changes were observed in the relaxation/flexibility condition, which served as an attention-placebo control. CONCLUSIONS: Graded exercise was associated with improvements in physical work capacity, as well as in specific psychological and cognitive variables. Improvements may be associated with the abandonment of avoidance behaviours.

Adolescent↗

PubMed2000

Randomised controlled trial of atraumatic versus standard needles for diagnostic lumbar puncture.

OBJECTIVE: To compare the ease of use of atraumatic needles with standard needles for diagnostic lumbar puncture and the incidence of headache after their use. DESIGN: Double blind, randomised controlled trial. SETTING: Investigation ward of a neurology unit in a university hospital. PARTICIPANTS: 116 patients requiring elective diagnostic lumbar puncture. INTERVENTIONS: Standardised protocol for lumbar puncture with 20 gauge atraumatic or standard needles. OUTCOME MEASURES: The primary end point was intention to treat analysis of incidence of moderate to severe headache, assessed at one week by telephone interview. Secondary end points were incidence of headache at one week analysed by needle type, ease of use by operator according to a visual analogue scale, incidence of backache, and failure rate of puncture. RESULTS: Valid outcome data were available for 97 of 101 patients randomised. Baseline characteristics were matched except for higher body mass index in the standard needle group. By an intention to treat analysis the absolute risk of moderate to severe headache with atraumatic needles was reduced by 26% (95% confidence interval 6% to 45%) compared with standard needles, but there was a non-significantly greater absolute risk of multiple attempts at lumbar puncture (14%, -4% to 32%). Higher body mass index was associated with an increased failure rate with atraumatic needles, but the reduced incidence of headache was maintained. The need for medical interventions was reduced by 20% (1% to 40%). CONCLUSIONS: Atraumatic needles significantly reduced the incidence of moderate to severe headache and the need for medical interventions after diagnostic lumbar punctures, but they were associated with a higher failure rate than standard needles.

Adult↗

PubMed2026

CanDo (Canadian Donor Milk) randomised controlled trial: pasteurised human donor milk supplementation in the well-baby unit - protocol.

INTRODUCTION: Mother's milk is the gold standard for feeding newborns. Despite lactation support while in hospital, supplementation rates remain high in Canadian well-baby units at 35-50%. When supplementation is needed, the choice between formula milk and pasteurised human donor milk (donor milk) remains uncertain with a lack of clinical trials to inform this practice. This study aims to compare the effect of supplementing mother's milk with donor milk versus formula in infants at higher risk for supplementation (infants of diabetic mothers, infants born small for gestational age or with a birth weight less than 2.5 kg and late preterm infants born between 350/7 and 366/7 weeks gestation). METHODS AND ANALYSIS: This is an ongoing, open-label, single-centre, randomised controlled trial conducted at Mount Sinai Hospital, Toronto, Canada. A total of 112 infants (56 per group) will be randomised to receive donor milk or infant formula as a supplement to mother's milk during their initial hospital stay, when supplementation is deemed necessary by the family and/or healthcare team. The primary outcome is exclusive human milk feeding at 4 months of age. Secondary outcomes include any or exclusive human milk feeding at 1, 2 and 3 months; infant growth and health indicators and breastfeeding self-efficacy. Exploratory outcomes encompass infant temperament; parental mental health (assessed using the State-Trait Anxiety Inventory and Edinburgh Postnatal Depression Scale); milk cortisol concentrations; and informal milk sharing comparing donor milk and formula supplementation. Follow-up includes monthly telephone assessments and a virtual or in-person visit at 4 months post partum. Data will be analysed using intention-to-treat principles. ETHICS AND DISSEMINATION: The CanDo trial has received ethics approval from the Mount Sinai Hospital Research Ethics Board and the University of Toronto. Results will be disseminated through peer-reviewed journals, conference presentations and stakeholder engagement with hospital and public health decision-makers. Findings will address a critical evidence gap regarding the use of donor milk supplementation in well-baby units and may inform future clinical practice and policy in newborn feeding. TRIAL REGISTRATION NUMBER: NCT06315127.

Humans↗

PubMed2006

A prospective randomised controlled trial of the Kiwi Omnicup versus conventional ventouse cups for vacuum-assisted vaginal delivery.

OBJECTIVE: To evaluate the performance and safety of the Kiwi Omnicup and compare it to conventional vacuum cups in routine clinical practice. DESIGN: A randomised controlled trial of the Kiwi Omnicup versus conventional vacuum cups. SETTING: Queen Charlotte's and Chelsea Hospital, a tertiary referral hospital in London from April 2001 to March 2004. POPULATION: Women requiring assisted vaginal delivery by ventouse. METHODS: Women were randomised to the Kiwi Omnicup (n=206) or conventional vacuum cups (n=198). Data regarding maternal demographics, labour, mode of delivery and maternal and neonatal outcome were collected. MAIN OUTCOME MEASURES: Failure of delivery with instrument of first choice. RESULTS: The Kiwi Omnicup was less successful at delivery with instrument of first choice than the conventional ventouse, failure rate 30.1 versus 19.2% (RR 1.58; 95% CI 1.10-2.24). It was associated with a greater number of cup detachments (mean 0.68 compared with 0.28, with 44% compared with 18% having at least one detachment [P<0.0001]). There was no difference in the incidence of severe maternal trauma, and there were no cases of serious neonatal injury. CONCLUSIONS: The Kiwi Omnicup is less successful than conventional ventouse in achieving vaginal delivery, but its safety profile is comparable.

Adult↗

PubMed2005

How strong is the evidence for the use of perioperative beta blockers in non-cardiac surgery? Systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To determine the effect of perioperative beta blocker treatment in patients having non-cardiac surgery. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Seven search strategies, including searching two bibliographic databases and hand searching seven medical journals. STUDY SELECTION AND OUTCOMES: We included randomised controlled trials that evaluated beta blocker treatment in patients having non-cardiac surgery. Perioperative outcomes within 30 days of surgery included total mortality, cardiovascular mortality, non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke, congestive heart failure, hypotension needing treatment, bradycardia needing treatment, and bronchospasm. RESULTS: Twenty two trials that randomised a total of 2437 patients met the eligibility criteria. Perioperative beta blockers did not show any statistically significant beneficial effects on any of the individual outcomes and the only nominally statistically significant beneficial relative risk was 0.44 (95% confidence interval 0.20 to 0.97, 99% confidence interval 0.16 to 1.24) for the composite outcome of cardiovascular mortality, non-fatal myocardial infarction, and non-fatal cardiac arrest. Methods adapted from formal interim monitoring boundaries applied to cumulative meta-analysis showed that the evidence failed, by a considerable degree, to meet standards for forgoing additional studies. The individual safety outcomes in patients treated with perioperative beta blockers showed a relative risk for bradycardia needing treatment of 2.27 (95% CI 1.53 to 3.36, 99% CI 1.36 to 3.80) and a nominally statistically significant relative risk for hypotension needing treatment of 1.27 (95% CI 1.04 to 1.56, 99% CI 0.97 to 1.66). CONCLUSION: The evidence that perioperative beta blockers reduce major cardiovascular events is encouraging but too unreliable to allow definitive conclusions to be drawn.

Adrenergic beta-Antagonists↗

PubMed2006

[The role of randomised controlled trials in the medical evaluation of routine procedures].

If a demand exists for the evaluation of the favourable and adverse effects of a medical procedure, a comparison is required; this comparison should be fair. The only procedure that ensures a fair comparison is randomisation. Randomised controlled trials (RCTs) therefore represent the gold standard in the evaluation of medical procedures; the non-application of a randomisation process must be justified in detail in individual cases. Reasons presented for not conducting an RCT are mainly based on a misunderstanding of the term "randomisation". They may also be based on circumstances where the conduct of any simultaneous comparison is unsuitable (independent of the mode of allocation) or on situations where there is practically no hypothesis available for a comparison, or even for a study. These factors are taken into account by the current regulations valid in Germany on the approval of drugs and on the reimbursement eligibility of health care services by statutory health insurance.

Biomedical Technology↗

PubMed2003

Association of n-3 polyunsaturated fatty acids with stability of atherosclerotic plaques: a randomised controlled trial.

BACKGROUND: N-3 polyunsaturated fatty acids (PUFAs) from oily fish protect against death from cardiovascular disease. We aimed to assess the hypothesis that incorporation of n-3 and n-6 PUFAs into advanced atherosclerotic plaques increases and decreases plaque stability, respectively. METHODS: We did a randomised controlled trial of patients awaiting carotid endarterectomy. We randomly allocated patients control, sunflower oil (n-6), or fish-oil (n-3) capsules until surgery. Primary outcome was plaque morphology indicative of stability or instability, and outcome measures were concentrations of EPA, DHA, and linoleic acid in carotid plaques; plaque morphology; and presence of macrophages in plaques. Analysis was per protocol. FINDINGS: 188 patients were enrolled and randomised; 18 withdrew and eight were excluded. Duration of oil treatment was 7-189 days (median 42) and did not differ between groups. The proportions of EPA and DHA were higher in carotid plaque fractions in patients receiving fish oil compared with those receiving control (absolute difference 0.5 [95% CI 0.3-0.7], 0.4 [0.1-0.6], and 0.2 [0.1-0.4] g/100 g total fatty acids for EPA; and 0.3 [0.0-0.8], 0.4 [0.1-0.7], and 0.3 [0.1-0.6] g/100 g total fatty acids for DHA; in plaque phospholipids, cholesteryl esters, and triacylglycerols, respectively). Sunflower oil had little effect on the fatty acid composition of lipid fractions. Fewer plaques from patients being treated with fish oil had thin fibrous caps and signs of inflammation and more plaques had thick fibrous caps and no signs of inflammation, compared with plaques in patients in the control and sunflower oil groups (odds ratio 0.52 [95% CI 0.24-0.89] and 1.19 [1.02-1.57] vs control; 0.49 [0.23-0.90] and 1.16 [1.01-1.53] vs sunflower oil). The number of macrophages in plaques from patients receiving fish oil was lower than in the other two groups. Carotid plaque morphology and infiltration by macrophages did not differ between control and sunflower oil groups. INTERPRETATION: Atherosclerotic plaques readily incorporate n-3 PUFAs from fish-oil supplementation, inducing changes that can enhance stability of atherosclerotic plaques. By contrast, increased consumption of n-6 PUFAs does not affect carotid plaque fatty-acid composition or stability over the time course studied here. Stability of plaques could explain reductions in non-fatal and fatal cardiovascular events associated with increased n-3 PUFA intake.

Aged↗

PubMed1996

Does suppressing luteinising hormone secretion reduce the miscarriage rate? Results of a randomised controlled trial.

OBJECTIVE: To determine whether prepregnancy pituitary suppression of luteinising hormone secretion with a luteinising hormone releasing hormone analogue improves the outcome of pregnancy in ovulatory women with a history of recurrent miscarriage, polycystic ovaries, and hypersecretion of luteinising hormone. DESIGN: Randomised controlled trial. SETTING: Specialist recurrent miscarriage clinic. SUBJECTS: 106 women with a history of three or more consecutive first trimester miscarriages, polycystic ovaries, and hypersecretion of luteinising hormone. INTERVENTIONS: Women were randomised before conception to receive pituitary suppression with a luteinising hormone releasing hormone analogue followed by low dose ovulation induction and luteal phase progesterone (group 1) or were allowed to ovulate spontaneously and then given luteal phase progesterone alone or luteal phase placebo alone (group 2). No drugs were prescribed in pregnancy. MAIN OUTCOME MEASURES: Conception and live birth rates over six cycles. RESULTS: Conception rates in the pituitary suppression and luteal phase support groups were 80% (40/50 women) and 82% (46/56) respectively (NS). Live birth rates were 65% (26/40) and 76% (35/46) respectively (NS). In the luteal phase support group there was no difference in the outcome of pregnancy between women given progesterone and those given placebo pessaries. Live birth rates from an intention to treat analysis were 52% (26/50 pregnancies) in the group given pituitary suppression and 63% (35/56) in the controls (NS). CONCLUSIONS: Prepregnancy suppression of high luteinising hormone concentrations in ovulatory women with recurrent miscarriage and hypersecretion of luteinising hormone does not improve the outcome of pregnancy. The outcome of pregnancy without pituitary suppression is excellent.

Abortion, Habitual↗

PubMed1993

Randomised controlled trial of albumin infusion in ill preterm infants.

We assessed the effect of albumin infusion on weight loss and ventilation requirement in sick premature infants. Thirty infants, median gestational age 29 weeks, were entered into a randomised controlled trial, at a median of 2 days of age. The infants, all with an albumin level < or = 30 g/l, received either 5 ml/kg of 20% albumin or 5 ml/kg of their maintenance fluids (placebo), both given as part of the total daily fluid requirement. The response to the infusion was assessed by comparing two periods; 12 h immediately prior to the infusion and 12-24 h after the infusion. Albumin infusion was associated with a significant increase in albumin level and a significant reduction in weight, but in the placebo group there was a significant increase in weight. There were, however, no significant changes in the peak inspiratory pressure in response to either infusion. There was only a modest reduction (< 15%) in the inspired oxygen concentration, which occurred in both groups, but reached statistical significance only following the albumin infusion. We conclude that our results suggest that albumin infusion in "hypoalbuminaemic" sick preterm infants is unlikely to alter their respiratory status.

Albumins↗

PubMed2004

The effect of a training course in aggression management on mental health nurses' perceptions of aggression: a cluster randomised controlled trial.

Nurses' attitudes towards patient aggression may influence their behaviour towards patients. Thus, their enhanced capacity to cope with aggressive patients may nurture more positive attitudes and alleviate adverse feelings emanating from patient aggression. This cluster randomised controlled trial conducted on six psychiatric wards tested the hypotheses that a 5 day training course in aggression management would positively influence the following outcome measures: Nurses' perception and tolerance towards patient aggression and resultant adverse feelings. A repeated measures design was employed to monitor change. No effect was found. The short time frame between the training course and the follow up measurement or non-responsiveness of the measurement instruments may explain this finding.

Adaptation, Psychological↗

PubMed2000

Promotion of condom use in a high-risk setting in Nicaragua: a randomised controlled trial.

BACKGROUND: In Latin America, motels rent rooms for commercial and non-commercial sex. We investigated the impact of providing health-education material and condoms on condom use in Managua, Nicaragua. METHODS: In a randomised controlled trial, in 19 motels, we gave condoms on request, made them available in rooms, or gave condoms directly to couples, with and without the presence of health-education material in the rooms. In a factorial design we assessed condom use directly by searching the rooms after couples had left. FINDINGS: 11 motels were used mainly by sex workers and their clients and eight mainly for non-commercial sex. 6463 couples attended the motels in 24 days. On 3106 (48.0%) occasions, at least one used condom was retrieved. Condom use was more frequent for commercial sex than for non-commercial sex (60.5 vs 20.2%). The presence of health-education material lowered the frequency of condom use for commercial sex (odds ratio 0.89 [95% CI 0.84-0.94]) and had no effect on use for non-commercial sex (1.03 [0.97-1.08]). Condom use increased for commercial (1.31 [1.09-1.75]) and non-commercial sex (1.81 (1.14-2.81) if condoms were available in rooms. Directly handing condoms to couples was similarly effective for commercial sex but less effective for non-commercial sex (1.32 [1.03-1.61] vs 1.52 [1.01-2.38]). INTERPRETATION: In Latin America, motels are key locations for promoting the use of condoms. Making condoms available in rooms is the most effective strategy to increase condom use, whereas use of health-education material was ineffective. These findings have important implications for HIV-prevention policies.

Condoms↗

PubMed2002

Efficacy of a Cancer Research UK communication skills training model for oncologists: a randomised controlled trial.

BACKGROUND: Doctors' communication with patients is commonly hampered by lack of training in this core skill. This study aimed to assess the efficacy of an intensive 3-day training course on communication skills in a randomised controlled trial with a two-by-two factorial design and several outcomes. METHODS: 160 oncologists from 34 UK cancer centres were randomly allocated to four groups: written feedback followed by course; course alone; written feedback alone; and control. At each of two assessment periods, consultations with six to ten consecutive, consenting patients per doctor were videotaped. 2407 patients participated. Outcome measures included objective and subjective ratings made by researchers, doctors, and patients. The primary outcomes were objective improvements after the intervention in key communication skills. Course content included structured feedback, videotape review of consultations, role-play with simulated patients, interactive group demonstrations, and discussion led by a trained facilitator. FINDINGS: In Poisson regression analysis of counts of communication behaviours, course attendance significantly improved key outcomes. The estimated effect sizes corresponded to higher rates of use of focused questions (difference between course attenders [n=80] and non-attenders [n=80] 34%, p=0.003), focused and open questions (27%, p=0.005), expressions of empathy (69%, p=0.003), and appropriate responses to patients' cues (38%, p=0.026), and a 24% lower rate of use of leading questions (p=0.11). There was little evidence for the effectiveness of written feedback. INTERPRETATION: The communication problems of senior doctors working in cancer medicine are not resolved by time and clinical experience. This trial shows that training courses significantly improve key communication skills. More resources should be allocated to address doctors' training needs in this vital area.

Adult↗