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Results for “Randomised Controlled Trial”

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PubMed2006

An evaluation of the clinical and cost-effectiveness of pulmonary artery catheters in patient management in intensive care: a systematic review and a randomised controlled trial.

OBJECTIVES: To evaluate the clinical and cost-effectiveness of managing critically ill patients in adult, general intensive care with or without pulmonary artery catheters (PACs). DESIGN: An open, multi-centre, randomised controlled trial with economic evaluation (cost-utility and cost-effectiveness analysis). SETTING: The setting was general (mixed medical/surgical) intensive care units (ICUs) in the UK admitting adults. PARTICIPANTS: Adult patients in participating ICUs deemed by the responsible treating clinician to require management with a PAC. INTERVENTIONS: These were insertion of a PAC and subsequent clinical management, at the discretion of the responsible treating clinicians, using data derived from the PAC. The control group were managed without a PAC but with the option of using alternative cardiac output monitoring devices. MAIN OUTCOME MEASURES: The main outcome measure was hospital mortality. Secondary outcome measures were length of stay in the ICU, length of stay in an acute hospital and organ-days of support in the ICU. For the economic evaluation, the main outcome measure was quality-adjusted life-years (QALYs) and the secondary outcome measure was hospital mortality. RESULTS: Sixty-five ICUs in the UK participated. Of these, 43 (66%) used alternative cardiac output monitoring devices in control group patients. A total of 1263 patients were identified as being eligible for the trial. Of these, 1041 (82.4%) were randomised and allocated to management with (n = 519) or without (n = 522) a PAC. There were no losses to follow-up. However, 27 patients (13 in the PAC group and 14 in the control group) were withdrawn from the trial because either the patient withdrew consent on recovering mental competency or the relatives withdrew agreement following randomisation. Data on 1014 patients were included in the analysis. Participants in the two groups had similar baseline characteristics. There was no difference in hospital mortality for patients managed with (68.4%) or without (65.7%) a PAC. The adjusted hazard ratio (PAC versus no PAC) was 1.09 [95% confidence interval (CI) 0.94 to 1.27]. There was no difference in the median length of stay in ICU, the median length of stay in an acute hospital or mean organ-days of support in ICU between the two groups. The economic evaluation found that the expected cost per QALY gained from the withdrawal of PAC was 2985 pounds. The expected cost per life gained from the withdrawal of PAC was 22,038 pounds. CONCLUSIONS: Clinical management of critically ill patients with a PAC, as currently practised in the UK, neither improves hospital survival for adult, general intensive care patients nor reduces length of stay in hospital. The lack of demonstrable benefit from a device previously believed to be beneficial could be explained by statistical chance, by misinterpretation of PAC-derived data, by ineffective treatment strategies based on data correctly interpreted using the current paradigm or by subsequent inaction following insertion of the device. It is also possible that detailed data on haemodynamics, however used, cannot modify the disease process sufficiently to influence disease outcome. The economic evaluation, using decision analysis techniques rather than conventional hypothesis testing, suggests that the withdrawal of the PAC from routine clinical practice in the NHS would be considered cost-effective in the current decision-making climate, and might result in lives or life-years being saved at modest cost. With the declining use of PACs in the UK and the findings of this report indicating no overall benefit from management with a PAC, it should now be possible to examine protocolised management with a PAC in selected groups of critically ill patients against appropriate controls, something that was difficult while PACs were the considered standard of care.

Adolescent↗

PubMed2004

Does a nurse-led mental health liaison service for older people reduce psychiatric morbidity in acute general medical wards? A randomised controlled trial.

OBJECTIVE: To determine the clinical effectiveness of a nurse-led mental health liaison service in managing mental health problems in older physically ill inpatients. DESIGN: Randomised controlled trial. SETTING: Four general medical wards in a district general hospital in a northern UK town. PARTICIPANTS: 153 medically ill older people (aged 65 or over) who scored above the threshold for depression and/or cognitive impairment on a brief screening instrument (4-item geriatric depression scale and 6-item orientation-memory-concentration test): 77 were randomised to a nurse-led intervention and 76 to usual care. Included in the analysis were 120 participants who completed 6-8 week follow-up assessments. INTERVENTION: Multi-faceted intervention led by a mental health liaison nurse. MAIN OUTCOME MEASURES: Scores on the Health of the Nation Outcome Scale 65+, the geriatric depression scale, and the Standardised Mini-Mental State Examination. RESULTS: No significant differences were found between groups on the total Health of the Nation Outcome Scale 65+ scores (11.5 versus 11.5, adjusted mean difference -0.04, 95% CI-1.4 to 1.3, P = 0.96) nor on the Standardised Mini-Mental State Examination (20.3 versus 21.8, adjusted mean difference -0.4, 95% CI-2.1 to 1.3, P = 0.63). Subjects randomised to the intervention arm had significantly lower Geriatric Depression Scale scores at 6-8 week follow-up than those receiving usual care (12.2 versus 14.0, adjusted mean difference -2.0, 95% CI-4.0 to -0.1, P = 0.043). CONCLUSIONS: Nurse-led mental health liaison services which accept all screened cases from acute medical wards are unlikely to be effective in reducing general psychiatric morbidity. Services which focus on the prevention of delirium and target particular patient groups or disorders such as depression are more likely to be effective.

Aged↗

PubMed1998

Laparoscopic vs conventional appendectomy--a meta-analysis of randomised controlled trials.

AIM: To compare the effectiveness and safety of laparoscopic and conventional "open" appendectomy in the treatment of acute appendicitis. METHODS: Meta-analysis of randomised controlled trials available by May 1998 that compared both techniques. Within each trial and for each outcome an effect size was calculated; the effect sizes were then pooled by a random-effects model. RESULTS: We summarised outcome data of 2877 patients included in 28 trials. Operating time was +16 min (95% confidence interval +12-20 min) longer for laparoscopic appendectomy. Overall complication rates were comparable, but wound infections were definitely reduced after laparoscopy [rate difference -4.2%, (-2.3% to -6.1%)]. Intra-abdominal abscesses, however, occurred slightly more frequently [+0.9%, (-0.4% to +2.3%)]. Hospital stay after laparoscopic appendectomy was 15 h (8-23 h) shorter, and patients returned to full fitness or work 7 days (5-9 days) earlier. Pain intensity on day 1 was slightly less. Heterogeneity was present for some outcome measures due to methodological differences among the primary studies. CONCLUSION: Laparoscopic appendectomy reduces wound infections and eases postoperative recovery. Nevertheless, the various differences among the primary studies and their partly flawed methodology make it difficult to generalise from these findings.

Acute Disease↗

PubMed2002

Effects of redesigned community postnatal care on womens' health 4 months after birth: a cluster randomised controlled trial.

BACKGROUND: Much postpartum physical and psychological morbidity is not addressed by present care, which tends to focus on routine examinations. We undertook a cluster randomised controlled trial to assess community postnatal care that has been redesigned to identify and manage individual needs. METHODS: We randomly allocated 36 general practice clusters from the West Midlands health region of the UK to intervention (n=17) or control (19) care. Midwives from the practices recruited women and provided care. 1087 (53%) of 2064 women were in practices randomly assigned to the intervention group, with 977 (47%) women in practices assigned to the control group. Care was led by midwives, with no routine contact with general practitioners, and was extended to 3 months. Midwives used symptom checklists and the Edinburgh postnatal depression scale (EPDS) to identify health needs and guidelines for the management of these needs. Primary outcomes at 4 months were obtained by postal questionnaire and included the women's short form 36 physical (PCS) and mental (MCS) component summary scores and the EPDS. Secondary outcomes were women's views about care. Multilevel analysis accounted for possible cluster effects. FINDINGS: 801 (77%) of 1087 women in the intervention group and 702 (76%) of 977 controls responded at 4 months. Women's mental health measures were significantly better in the intervention group (MCS, 3.03 [95% CI 1.53-4.52]; EPDS -1.92 [-2.55 to -1.29]; EPDS 13+ odds ratio 0.57 [0.43-0.76]) than in controls, but the physical health score did not differ. INTERPRETATION: Redesign of care so that it is midwife-led, flexible, and tailored to needs, could help to improve women's mental health and reduce probable depression at 4 months' postpartum.

Adult↗

PubMed2003

Mailed prescriber feedback in addition to a clinical guideline has no impact: a randomised, controlled trial.

OBJECTIVE: To evaluate the impact of feedback on the prescribing of antibiotics supplementary to clinical guidelines in the treatment of respiratory tract infections. DESIGN: Randomised, controlled trial with GPs allocated to one of two groups. The first group received clinical guidelines on the treatment of respiratory tract infections plus postal feedback with aggregated data on their prescribing patterns for antibiotics. The second group served as controls for the first group and received the guidelines only. SETTING: 299 GPs representing 181 practices with 455,843 listed patients in the County of Funen, Denmark. MAIN OUTCOME MEASURES: Effects on GP prescribing patterns were measured by means of a prescription database and followed for a period of 2 years with 2 outcome measures: 1) the antibiotic prescription rate and 2) the fraction of prescriptions for narrow-spectrum antibiotics. RESULTS: The addition of feedback had no impact on GP prescribing patterns. CONCLUSION: Postal disseminated prescriber feedback in addition to a clinical guideline on the diagnosis and treatment of respiratory tract infections does not influence GP prescribing patterns. Interventions aimed at improving performance in general practice should go beyond just giving GPs information on whether they are living up to standards.

Anti-Bacterial Agents↗

PubMed2000

Obstacles to a randomised controlled trial of intensive dynamic psychotherapy: an account of the New South Wales Section of Psychotherapy outcomes project.

OBJECTIVE: This paper examines the obstacles to a randomised controlled trial (RCT) of intensive dynamic psychotherapy (IDP) by reference to the fate of the New South Wales Section of Psychotherapy outcomes project. METHOD: Planning was complete and the final research protocol was about to be implemented when funding difficulties led to suspension of the project. The opinions of the research subcommittee regarding the main obstacles to the ultimate success of the project are now analysed in the expectation that better research strategies will follow. RESULTS: With hindsight, six of the eight members of the research subcommittee reported that the project was not feasible. By choice of questionnaire items they identified the greatest threats to a successful trial as: standardisation of the procedures, termination at 24 months, the availability of funding and the choice of treatment procedures. The most frequently volunteered concerns related to the enlistment and cooperation of the trial therapists (5), standardisation of the experimental therapy (3), probable shortfall in trial subjects (3) and the availability of funding (2). CONCLUSIONS: The most powerful general obstacles to success of the project related to the standardisation of procedures and the failure to maintain sufficient cooperation of trial therapists. The protocol required IDP therapists to terminate procedures at 24 months, which contradicted their usual practices and led to some alienation from the project. Amendments to the protocol might improve the possibility of a successful trial. However, one might also conclude that it is premature to attempt a naturalistic RCT of IDP.

Adult↗

PubMed2000

Corticosteroid therapy in nephrotic syndrome: a meta-analysis of randomised controlled trials.

AIMS: To determine the benefits and toxicity of different corticosteroid regimes in preventing relapse in steroid responsive nephrotic syndrome. DESIGN: Meta-analysis of randomised controlled trials. SUBJECTS: Twelve trials involving 868 children aged 3 months to 18 years. MAIN OUTCOME MEASURE: Frequency of relapse. RESULTS: A meta-analysis of five trials, which compared two months of prednisone with three months or more in the first episode, showed that the longer duration significantly reduced the risk of relapse at 12-24 months (relative risk 0.73; 95% confidence interval 0.60 to 0.89) without an increase in adverse events. There was an inverse linear relation (relative risk 1.382 (SE 0.215) - 0.133 (SE 0.048) duration; r(2) = 0.66; p = 0.05) between the duration of treatment and risk of relapse. CONCLUSIONS: Children in their first episode of steroid responsive nephrotic syndrome should be treated with prednisone for at least three months, with an increase in benefit being shown for up to seven months of treatment.

Adolescent↗

PubMed2000

Physiotherapy for anterior knee pain: a randomised controlled trial.

OBJECTIVE: To determine the efficacy of the individual components of physiotherapy in subjects with anterior knee pain. METHODS: An observer blind, prospective, factorial design randomised controlled trial. 81 young adults with anterior knee pain were randomly allocated to one of four treatment groups: (1) exercise, taping, and education; (2) exercise and education; (3) taping and education; and (4) education alone. Each group received six physiotherapist-led treatments over three months. Follow up took place at three months using the following outcome measures: patient satisfaction (discharge/refer for further treatment); a visual analogue pain score; the WOMAC lower limb function score; the Hospital Anxiety and Depression scale (HAD); and quadriceps strength. At 12 months the WOMAC and HAD were assessed by postal questionnaire. RESULTS: All groups showed significant improvements in WOMAC, visual analogue, and HAD scores; these improvements did not vary significantly between the four groups or between exercising/non-exercising and taped/non-taped patients at three and 12 months. However, patients who exercised were significantly more likely to be discharged at three months than non-exercising patients (chi(2), p<0.001). Taping was not significantly associated with discharge. Significantly greater improvements in WOMAC, visual analogue, and the anxiety score (but not the depression score) were seen in patients who were discharged than in those who were referred. CONCLUSIONS: The proprioceptive muscle stretching and strengthening aspects of physiotherapy have a beneficial effect at three months sufficient to permit discharge from physiotherapy. These benefits are maintained at one year. Taping does not influence the outcome.

Adolescent↗

PubMed1995

Cognitive behavioural therapy for medically unexplained physical symptoms: a randomised controlled trial.

OBJECTIVE: To examine the additional effect of cognitive behavioural therapy for patients with medically unexplained physical symptoms in comparison with optimised medical care. DESIGN: Randomised controlled trial with follow up assessments six and 12 months after the baseline evaluation. SETTING: General medical outpatient clinic in a university hospital. SUBJECTS: An intervention group of 39 patients and a control group of 40 patients. INTERVENTIONS: The intervention group received between six and 16 sessions of cognitive behavioural therapy. Therapeutic techniques used included identification and modification of dysfunctional automatic thoughts and behavioural experiments aimed at breaking the vicious cycles of the symptoms and their consequences. The control group received optimised medical care. MAIN OUTCOME MEASURES: The degree of change, frequency and intensity of the presenting symptoms, psychological distress, functional impairment, hypochondriacal beliefs and attitudes, and (at 12 months of follow up) number of visits to the general practitioner. RESULTS: At six months of follow up the intervention group reported a higher recovery rate (odds ratio 0.40; 95% confidence interval 0.16 to 1.00), a lower mean intensity of the physical symptoms (difference -1.2; -2.0 to -0.3), and less impairment of sleep (odds ratio 0.38; 0.15 to 0.94) than the controls. After adjustment for coincidental baseline differences the intervention and control groups also differed with regard to frequency of the symptoms (0.32; 0.13 to 0.77), limitations in social (0.35; 0.14 to 0.85) and leisure (0.36; 0.14 to 0.93) activities, and illness behaviour (difference -2.5; -4.6 to -0.5). At 12 months of follow up the differences between the groups were largely maintained. CONCLUSION: Cognitive behavioural therapy seems to be a feasible and effective treatment in general medical patients with unexplained physical symptoms.

Adolescent↗

PubMed1998

Systematic review of randomised controlled trials of interventions for painful shoulder: selection criteria, outcome assessment, and efficacy.

OBJECTIVE: To review the efficacy of common interventions for shoulder pain. DESIGN: All randomised controlled trials of non-steroidal anti-inflammatory drugs, intra-articular and subacromial glucocorticosteroid injection, oral glucocorticosteroid treatment, physiotherapy, manipulation under anaesthesia, hydrodilatation, and surgery for shoulder pain that were identified by computerised and hand searches of the literature and had a blinded assessment of outcome were included. MAIN OUTCOME MEASURES: Methodological quality (score out of 40), selection criteria, and outcome measures. Effect sizes were calculated and combined in a pooled analysis if study population, end point, and intervention were comparable. RESULTS: Thirty one trials met inclusion criteria. Mean methodological quality score was 16.8 (9.5-22). Selection criteria varied widely, even for the same diagnostic label. There was no uniformity in the outcome measures used, and their measurement properties were rarely reported. Effect sizes for individual trials were small (range -1.4 to 3.0). The results of only three studies investigating "rotator cuff tendinitis" could be pooled. The only positive finding was that subacromial steroid injection is better than placebo in improving the range of abduction (weighted difference between means 35 degrees (95% confidence interval 14 to 55)). CONCLUSIONS: There is little evidence to support or refute the efficacy of common interventions for shoulder pain. As well as the need for further well designed clinical trials, more research is needed to establish a uniform method of defining shoulder disorders and developing outcome measures which are valid, reliable, and responsive in affected people.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1998

Effectiveness of screening older people for impaired vision in community setting: systematic review of evidence from randomised controlled trials.

OBJECTIVE: To assess whether population screening for impaired vision among older people in the community leads to improvements in vision. DESIGN: Systematic review of randomised controlled trials of population screening in the community that included any assessment of vision or visual function with at least 6 months' follow up. SUBJECTS: Adults aged 65 or over. MAIN OUTCOME MEASURE: Proportions with visual impairment in intervention and control groups with any method of assessing visual impairment. RESULTS: There were no trials that primarily assessed visual screening. Outcome data on vision were available for 3494 people in five trials of multiphasic assessment. All the trials used self reported measures for vision impairment, both as screening tools and as outcome measures. The inclusion of a visual screening component in the assessment did not result in improvements in self reported visual problems (pooled odds ratio 1.04:95% confidence interval 0.89 to 1.22). A small reduction (11%) in the number of older people with self reported visual problems cannot be excluded. CONCLUSIONS: Screening of asymptomatic older people in the community is not justified on present evidence. Visual impairment in this age group can usually be reduced with treatment. It is unclear why no benefit was seen. Further work is needed to clarify what interventions are appropriate for older people with unreported impairment of vision.

Aged↗

PubMed1998

Effectiveness of antibiotic prophylaxis in critically ill adult patients: systematic review of randomised controlled trials.

OBJECTIVE: To determine whether antibiotic prophylaxis reduces respiratory tract infections and overall mortality in unselected critically ill adult patients. DESIGN: Meta-analysis of randomised controlled trials from 1984 and 1996 that compared different forms of antibiotic prophylaxis used to reduce respiratory tract infections and mortality with aggregate data and, in a subset of trials, data from individual patients. SUBJECTS: Unselected critically ill adult patients; 5727 patients for aggregate data meta-analysis, 4343 for confirmatory meta-analysis with data from individual patients. MAIN OUTCOME MEASURES: Respiratory tract infections and total mortality. RESULTS: Two categories of eligible trials were defined: topical plus systemic antibiotics versus no treatment and topical preparation with or without a systemic antibiotic versus a systemic agent or placebo. Estimates from aggregate data meta-analysis of 16 trials (3361 patients) that tested combined treatment indicated a strong significant reduction in infection (odds ratio 0.35; 95% confidence interval 0.29 to 0.41) and total mortality (0.80; 0.69 to 0.93). With this treatment five and 23 patients would need to be treated to prevent one infection and one death, respectively. Similar analysis of 17 trials (2366 patients) that tested only topical antibiotics indicated a clear reduction in infection (0.56; 0.46 to 0.68) without a significant effect on total mortality (1.01; 0.84 to 1.22). Analysis of data from individual patients yielded similar results. No significant differences in treatment effect by major subgroups of patients emerged from the analyses. CONCLUSIONS: This meta-analysis of 15 years of clinical research suggests that antibiotic prophylaxis with a combination of topical and systemic drugs can reduce respiratory tract infections and overall mortality in critically ill patients. This effect is significant and worth while, and it should be considered when practice guidelines are defined.

Administration, Topical↗

PubMed2000

Costs and effectiveness of community postnatal support workers: randomised controlled trial.

OBJECTIVES: To establish the relative cost effectiveness of postnatal support in the community in addition to the usual care provided by community midwives. DESIGN: Randomised controlled trial with six month follow up. SETTING: Recruitment in a university teaching hospital and care provided in women's homes. PARTICIPANTS: 623 postnatal women allocated at random to intervention (311) or control (312) group. INTERVENTION: Up to 10 home visits in the first postnatal month of up to three hours duration by a community postnatal support worker. MAIN OUTCOME MEASURE: General health status as measured by the SF-36 and risk of postnatal depression. Breast feeding rates, satisfaction with care, use of services, and personal costs. RESULTS: At six weeks there was no significant improvement in health status among the women in the intervention group. At six weeks the mean total NHS costs were pound 635 for the intervention group and pound 456 for the control group (P=0.001). At six months figures were pound 815 and pound 639 (P=0.001). There were no differences between the groups in use of social services or personal costs. The women in the intervention group were very satisfied with the support worker visits. CONCLUSIONS: There was no health benefit of additional home visits by community postnatal support workers compared with traditional community midwifery visiting as measured by the SF-36. There were no savings to the NHS over six months after the introduction of the community postnatal support worker service.

Adolescent↗

PubMed2000

Effects of a programme of multifactorial home visits on falls and mobility impairments in elderly people at risk: randomised controlled trial.

OBJECTIVE: To evaluate whether a programme of multifactorial home visits reduces falls and impairments in mobility in elderly people living in the community. DESIGN: Randomised controlled trial with 18 months of follow up. SETTING: Six general practices in Hoensbroek, the Netherlands. PARTICIPANTS: 316 people aged 70 and over living in the community, with moderate impairments in mobility or a history of recent falls. INTERVENTION: Five home visits by a community nurse over a period of one year. Visits consisted of screening for medical, environmental, and behavioural factors causing falls and impairments in mobility, followed by specific advice, referrals, and other actions aimed at dealing with the observed hazards. MAIN OUTCOME MEASURES: Falls and impairments in mobility. RESULTS: No differences were found in falls and mobility outcomes between the intervention and usual care groups. CONCLUSION: Multifactorial home visits had no effects on falls and impairments in mobility in elderly people at risk who were living in the community. Because falls and impairments in mobility remain a serious problem among elderly people, alternative strategies should be developed and evaluated.

Accidental Falls↗

PubMed2001

Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media.

OBJECTIVE: To compare immediate with delayed prescribing of antibiotics for acute otitis media. DESIGN: Open randomised controlled trial. SETTING: General practices in south west England. PARTICIPANTS: 315 children aged between 6 months and 10 years presenting with acute otitis media. INTERVENTIONS: Two treatment strategies, supported by standardised advice sheets-immediate antibiotics or delayed antibiotics (antibiotic prescription to be collected at parents' discretion after 72 hours if child still not improving). MAIN OUTCOME MEASURES: Symptom resolution, absence from school or nursery, paracetamol consumption. RESULTS: On average, symptoms resolved after 3 days. Children prescribed antibiotics immediately had shorter illness (-1.1 days (95% confidence interval -0.54 to -1.48)), fewer nights disturbed (-0.72 (-0.30 to -1.13)), and slightly less paracetamol consumption (-0.52 spoons/day (-0.26 to -0.79)). There was no difference in school absence or pain or distress scores since benefits of antibiotics occurred mainly after the first 24 hours-when distress was less severe. Parents of 36/150 of the children given delayed prescriptions used antibiotics, and 77% were very satisfied. Fewer children in the delayed group had diarrhoea (14/150 (9%) v 25/135 (19%), chi(2)=5.2, P=0.02). Fewer parents in the delayed group believed in the effectiveness of antibiotics and in the need to see the doctor with future episodes. CONCLUSION: Immediate antibiotic prescription provided symptomatic benefit mainly after first 24 hours, when symptoms were already resolving. For children who are not very unwell systemically, a wait and see approach seems feasible and acceptable to parents and should substantially reduce the use of antibiotics for acute otitis media.

Acetaminophen↗

PubMed2002

Improving teenagers' knowledge of emergency contraception: cluster randomised controlled trial of a teacher led intervention.

OBJECTIVE: To assess the effectiveness of a teacher led intervention to improve teenagers' knowledge about emergency contraception. DESIGN: Cluster randomised controlled trial. SETTING: 24 mixed sex, state secondary schools in Avon, south west England. PARTICIPANTS: 1974 boys and 1820 girls in year 10 (14-15 year olds). INTERVENTION: Teachers gave a single lesson on emergency contraception to year 10 pupils. The teachers had previously received in-service training on giving the lesson. The pupils were actively involved during the lesson. MAIN OUTCOME MEASURES: Questionnaires distributed to pupils at baseline and six months after the intervention assessed their knowledge of the correct time limits for hormonal emergency contraception and for use of the intrauterine device as emergency contraception, the proportion of pupils who were not virgins, the proportion who had used emergency contraception, and the pupils' intention to use emergency contraception in the future. RESULTS: The proportion of pupils knowing the correct time limits for both types of emergency contraception was significantly higher in the intervention group than in the control group at six months' follow up (hormonal contraception: proportion of boys 15.9% higher (95% confidence interval 6.5% to 25.3%), girls 20.4% (10.4% to 30.4%); intrauterine device used as emergency contraception: boys 4.2% (0.7% to 7.7%), girls 10.7% (0.4% to 21.0%). The number of pupils needed to be taught for one more pupil to know the correct time limits was six for boys and five for girls. The intervention and control groups did not differ in the proportion of pupils who were not virgins, in the proportion who had used emergency contraception, and in the proportion intending to use emergency contraception in the future. CONCLUSIONS: The intervention significantly improved the proportion of boys and girls knowing the correct time limits for both types of emergency contraception. The intervention did not change the pupils' sexual activity or use of emergency contraception.

Adolescent↗

PubMed2002

General practice based intervention to prevent repeat episodes of deliberate self harm: cluster randomised controlled trial.

OBJECTIVES: To evaluate the impact of an intervention based in general practice on the incidence of repeat episodes of deliberate self harm. DESIGN: Cluster randomised controlled trial in which 98 general practices were assigned in equal numbers to an intervention or a control group. The intervention comprised a letter from the general practitioner inviting the patient to consult, and guidelines on assessment and management of deliberate self harm for the general practitioner to use in consultations. Control patients received usual general practitioner care. SETTING: General practices within Avon, Wiltshire, and Somerset Health Authorities, whose patients lived within the catchment area of four general hospitals in Bristol and Bath. PARTICIPANTS: 1932 patients registered with the study practices who had attended accident and emergency departments at one of the four hospitals after an episode of deliberate self harm. MAIN OUTCOME MEASURES: Primary outcome was occurrence of a repeat episode of deliberate self harm in the 12 months after the index episode. Secondary outcomes were number of repeat episodes and time to first repeat. RESULTS: The incidence of repeat episodes of deliberate self harm was not significantly different for patients in the intervention group compared with the control group (odds ratio 1.2, 95% confidence interval 0.9 to 1.5). Similar findings were obtained for the number of repeat episodes and time to first repeat. Subgroup analyses indicated that there was no differential effect of the intervention according to patient's sex (P=0.51) or method used to cause deliberate self harm (P=0.64). The treatment seemed to be beneficial for people with a history of deliberate self harm, but it was associated with an adverse effect in people for whom the index episode was their first episode (interaction P=0.017). CONCLUSIONS: An invitation to consult, sent by the general practitioner of patients who have deliberately harmed themselves, and the use of management guidelines during any subsequent consultation did not reduce the incidence of repeat self harm. A subgroup analysis that indicated that patients who had previously harmed themselves benefited from the intervention was inconsistent with previous evidence and should be treated with caution. More research is needed on how to manage patients who deliberately harm themselves, to reduce the incidence of repeat episodes.

Adolescent↗

PubMed2004

Using an electrocautery strategy or recombinant follicle stimulating hormone to induce ovulation in polycystic ovary syndrome: randomised controlled trial.

OBJECTIVE: To compare the effectiveness of an electrocautery strategy with ovulation induction using recombinant follicle stimulating hormone in patients with polycystic ovary syndrome. DESIGN: Randomised controlled trial. SETTING: Secondary and tertiary hospitals in the Netherlands. PARTICIPANTS: 168 patients with clomiphene citrate resistant polycystic ovary syndrome: 83 were allocated electrocautery and 85 were allocated recombinant follicle stimulating hormone. INTERVENTION: Laparoscopic electrocautery of the ovaries followed by clomiphene citrate and recombinant follicle stimulating hormone if anovulation persisted, or induction of ovulation with recombinant follicle stimulating hormone. MAIN OUTCOME MEASURE: Ongoing pregnancy within 12 months. RESULTS: . The cumulative rate of ongoing pregnancy after recombinant follicle stimulating hormone was 67%. With only electrocautery it was 34%, which increased to 49% after clomiphene citrate was given. Subsequent recombinant follicle stimulating hormone increased the rate to 67% at 12 months (rate ratio 1.01, 95% confidence interval 0.81 to 1.24). No complications occurred from electrocautery with or without clomiphene citrate. Patients allocated to electrocautery had a significantly lower risk of multiple pregnancy (0.11, 0.01 to 0.86). CONCLUSION: The ongoing pregnancy rate from ovulation induction with laparoscopic electrocautery followed by clomiphene citrate and recombinant follicle stimulating hormone if anovulation persisted, or recombinant follicle stimulating hormone, seems equivalent to ovulation induction with recombinant follicle stimulating hormone, but the former procedure carries a lower risk of multiple pregnancy.

Adult↗