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Results for “Randomised Controlled Trial”

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PubMed2000

Randomised controlled trial of early surgery versus watchful waiting for glue ear: the effect on behavioural problems in pre-school children.

This trial was designed to compare early surgery with watchful waiting for persistent bilateral otitis media with effusion (OME) in terms of hearing loss and behavioural problems in pre-school children. A randomised controlled trial compared the effects of early treatment with ventilation tubes versus watchful waiting for 9 months. Results were analysed by intention-to-treat. One hundred and eighty-two pre-school children (date of birth between 1 April 1991 and 31 December 1992), mean age of 2.9 years (SD 0.85) with at least a 3-month history of bilateral OME and hearing loss of greater than 25 dB were treated in Bristol Children's Hospital between November 1993 and January 1996. Bilateral ventilation tubes were inserted within 6 weeks of randomisation or within 6 weeks of reassessment after 9 months of watchful waiting, with a final assessment at 18 months. The main outcome measures were behavioural problems, measured by the Richman Behaviour Checklist, and hearing loss at 4000 Hz in the better hearing ear. Early surgical intervention significantly reduced behavioural problems by 17% (95% CI, 2% - 33%). This difference was largely mediated by concurrent hearing loss. After 18 months, there was no longer a significant difference (95% Cl, -19% to +10%). However, the majority (85%) of the Watchful Waiting group had required surgery and 22% of all children still had behavioural problems.

Child Behavior Disorders↗

PubMed1998

Methods for economic evaluation alongside a multicentre trial in developing countries: a case study from the WHO Antenatal Care Randomised Controlled Trial.

The WHO is testing a new rationalised programme of antenatal care in a multicentre randomised trial. The motivation for this trial arose from the current uncertainty about the effectiveness of different approaches to provision of routine antenatal care. Decision makers also lack information about the costs of providing routine antenatal care and the cost-effectiveness of one programme over another. Such information will be needed before the final choice of programme can be made. The WHO trial provides an ideal opportunity to estimate and compare the incremental costs and cost-effectiveness of the new programme in four countries (Argentina, Cuba, Saudi Arabia, Thailand). A separate economic component has been organised to measure the costs of antenatal care. Methods for cost identification and measurement, and methods for economic analysis in the context of an international study are based on current recommendations for the conduct of economic evaluations alongside trials. However, several aspects require further development. In particular, this includes defining standard methods for costing in different countries; measuring women's costs of access to care; and making comparisons across international settings. The economic evaluation will also inform similar multicentre international trials and investigate issues of generalisability beyond trial settings.

Argentina↗

PubMed2001

Randomised controlled trial of brief psychological intervention after deliberate self poisoning.

OBJECTIVES: To determine the effects of a brief psychological intervention (brief psychodynamic interpersonal therapy) for patients after deliberate self poisoning compared with usual treatment. To compare the impact of the active intervention and usual treatment on patients' satisfaction with care. DESIGN: Randomised controlled trial. PARTICIPANTS: 119 adults who had deliberately poisoned themselves and presented to the emergency department of a teaching hospital. SETTING: Community based study. INTERVENTION: Four sessions of therapy delivered in the patient's home. Control patients received "treatment as usual," which in most cases consisted of referral back to their general practitioner. OUTCOME MEASURES: Severity of suicidal ideation six months after treatment as assessed by the Beck scale for suicidal ideation. Secondary outcome measures at six month follow up included depressive symptoms as measured by the Beck depression inventory, patient satisfaction with treatment, and self reported subsequent attempts at self harm. RESULTS: Participants randomised to the intervention had a significantly greater reduction in suicidal ideation at six month follow up compared with those in the control group (reduction in the mean (SD) Beck scale 8.0 v 1.5). They were more satisfied with their treatment and were less likely to report repeated attempts to harm themselves at follow up (proportion repeating 9% v 28% in control group; difference 19%, 95% confidence interval 9% to 30 %, P=0.009). CONCLUSION: Brief psychodynamic interpersonal therapy may be a valuable treatment after people have deliberately tried to poison themselves.

Adolescent↗

PubMed2006

Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204].

BACKGROUND: Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. METHODS/DESIGN: A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 and < 39 weeks gestation, planning a vaginal birth, not in active labour, with a singleton, viable fetus of vertex presentation, are eligible to participate. Allocation concealment is achieved using telephone randomisation. Participants assigned to hypnosis groups commence hypnosis training as near as possible to 37 weeks gestation. Treatment allocations are concealed from treating obstetricians, anaesthetists, midwives and those personnel collecting and analysing data. Our sample size of 135 women/group gives the study 80% power to detect a clinically relevant fall of 20% in the number of women requiring pharmacological analgesia - the primary endpoint. We estimate that approximately 5-10% of women will deliver prior to receiving their allocated intervention. We plan to recruit 150 women/group and perform sequential interim analyses when 150 and 300 participants have been recruited. All participant data will be analysed, by a researcher blinded to treatment allocation, according to the "Intention to treat" principle with comprehensive pre-planned cost- benefit and subgroup analyses. DISCUSSION: If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and this trial will provide evidence to guide clinical practice.

Journal Article↗

PubMed2026

Effectiveness of chlorhexidine gluconate-impregnated dressings in preventing central line-associated bloodstream infection in a paediatric intensive care unit: A randomised controlled trial.

OBJECTIVES: To compare the effectiveness and dermatological safety of chlorhexidine gluconate (CHG)-impregnated dressings versus conventional transparent dressings in preventing central line-associated bloodstream infection (CLABSI) in paediatric patients admitted to a PICU. METHODS: A single-blind, randomised controlled trial with a 1:1 allocation ratio was conducted in a tertiary PICU. A total of 250 paediatric patients with a central venous catheter were included (125 per group). Patient characteristics, catheter-related variables, catheter dwell time and skin alterations were recorded. The primary outcome was CLABSI, defined according to CDC/NHSN criteria. Bivariate analyses and multivariable logistic regression were performed, including clinically relevant covariates related to catheter exposure, dressing type, and vaccination status. The trial was registered at ClinicalTrials.gov (NCT07175116). RESULTS: CLABSI incidence was significantly lower in the CHG group compared with the conventional dressing group (2.4% vs. 18.4%; p < 0.001). In multivariable analysis, CHG-impregnated dressings were independently associated with reduced CLABSI risk (OR = 0.15; 95% CI: 0.04-0.58). Longer catheter dwell time (OR = 1.13 per day; 95% CI: 1.04-1.22) and absence of complete vaccination (OR = 8.68; 95% CI: 2.48-30.47) were also associated with increased infection risk. Incomplete vaccination showed a similar trend without reaching statistical significance (OR = 6.48; 95% CI: 0.95-44.20). Skin alterations were more frequent in the CHG group (16.8% vs. 11.2%), predominantly in younger infants. CONCLUSIONS: CHG-impregnated dressings were associated with a significant reduction in CLABSI incidence in critically ill paediatric patients, although their use was linked to a modest increase in mild skin reactions. IMPLICATIONS FOR CLINICAL PRACTICE: CHG-impregnated dressings may be considered as part of a multifaceted infection prevention strategy, alongside appropriate catheter management, minimisation of catheter manipulation and proactive skin monitoring, with cautious and individualised use in infants.

Humans↗

PubMed2002

Nonoxynol-9 spermicide for prevention of vaginally acquired HIV and other sexually transmitted infections: systematic review and meta-analysis of randomised controlled trials including more than 5000 women.

We aimed to determine the effectiveness of the vaginally administered spermicide nonoxynol-9 (N-9) among women for the prevention of HIV and other sexually transmitted infections (STIs). We did a systematic review of randomised controlled trials. Nine such trials including 5096 women, predominantly sex workers, comparing N-9 with placebo or no treatment, were included. Primary outcomes were new HIV infection, new episodes of various STIs, and genital lesions. Five trials included HIV and nine included STI outcomes, and all but one (2% of the data) contributed to the meta-analysis. Overall, relative risks of HIV infection (1.12, 95% confidence interval 0.88-1.42), gonorrhoea (0.91, 0.67-1.24), chlamydia (0.88, 0.77-1.01), cervical infection (1.01, 0.84-1.22), trichomoniasis (0.84, 0.69-1.02), bacterial vaginosis (0.88, 0.74-1.04) and candidiasis (0.97, 0.84-1.12) were not significantly different in the N-9 and placebo or no treatment groups. Genital lesions were more common in the N-9 group (1.18, 1.02-1.36). Our review has found no statistically significant reduction in risk of HIV and STIs, and the confidence intervals indicate that any protection that may exist is likely to be very small. There is some evidence of harm through genital lesions. N-9 cannot be recommended for HIV and STI prevention.

Adult↗

PubMed2004

A randomised controlled trial of senior Lay Health Mentoring in older people with ischaemic heart disease: The Braveheart Project.

OBJECTIVE: to examine the effects and feasibility of educating and empowering older people with ischaemic heart disease using trained senior lay health mentors. DESIGN: randomised controlled trial with blinded evaluation. SETTING: Falkirk and District Royal Infirmary. PARTICIPANTS: inpatients and outpatients aged 60 or over attending secondary care with a diagnosis of angina or acute myocardial infarction. Three-hundred and nineteen entered and 289 completed exit assessments. The intervention group took part in mentoring groups for 1 year, meeting monthly for 2 hours, each led by two trained lay health mentors in addition to standard care. MAIN OUTCOME MEASURES: primary outcome measures were changes in coronary risk factors, medication usage and actual use of secondary care health services. Secondary outcomes were total and cardiovascular events; changes in medication compliance, non-medical support requirement, health status and psychological functioning, and social inclusion. RESULTS: there were significant improvements in a reported current exercise score (mean +0.33, +0.02 to +0.52), in the average time spent walking per week by 72 minutes (+1 to +137 minutes), and in the SF36 Physical Functioning Score (+6.1, +2.4 to +9.5). There was a 1.0% reduction in total fat (95% CI -3.0% to -0.6%) and a 0.6% reduction in saturated fat (95% CI -1.5% to -0.03%). The intervention group showed reduced outpatient attendance for coronary heart disease (-0.25 appointments, -0.61 to -0.08). Attendance rates were high. Socio-economic grouping did not affect participation. CONCLUSIONS: Lay Health Mentoring is feasible, practical and inclusive, positively influencing diet, physical activity, and health resource utilisation in older subjects with ischaemic heart disease without causing harm.

Aged↗

PubMed2005

A randomised controlled trial comparing low dose vaginal misoprostol and dinoprostone vaginal gel for inducing labour at term.

OBJECTIVE: To compare the efficacy of low dose vaginal misoprostol and dinoprostone vaginal gel for induction of labour at term. DESIGN: A single-blind randomised controlled trial. SETTING: Antenatal and labour ward of a UK district general hospital. PARTICIPANTS: Two hundred and sixty-eight women requiring induction of labour at term (>37 weeks of gestation) with no significant fetal or medical condition, no previous uterine surgery and no contraindication to prostaglandin. METHODS: Misoprostol 25 microg (one-quarter of a 100 microg tablet) was inserted into the posterior vaginal fornix every 4 hours (to a maximum of six doses) or dinoprostone vaginal gel 1-2 mg 6 hourly (maximum of 3 mg in 24 hours). MAIN OUTCOME MEASURE: Induction-to-vaginal delivery interval. SECONDARY OUTCOME MEASURES: Requirements for oxytocin, mode of delivery, number of women delivering < 24 hours, incidence of uterine contraction abnormalities, incidence of abnormal cardiotocograph (CTG) recordings, 5-minute Apgar scores, umbilical cord pH recordings, analgesia requirements, admission to NICU and blood loss at delivery. RESULTS: There were no significant differences between the two groups in induction-to-vaginal delivery interval, mode of delivery, number of women delivering within 24 hours and neonatal outcomes. The incidence of uterine contraction abnormalities (tachysystole and hyperstimulation) and the incidence of abnormal CTG recordings were also similar for both groups. CONCLUSION: Low dose vaginal misoprostol is as effective as dinoprostone gel for inducing labour at term. There would be substantial cost savings, estimated at around 3.9 million UK pounds per annum, for maternity services if low dose misoprostol became the agent of choice for inducing labour in the UK.

Administration, Intravaginal↗

PubMed2004

A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis.

OBJECTIVE: To investigate the efficacy of corticosteroid injections into the carpometacarpal joint of the thumb (CMCJ) in patients with osteoarthritis. DESIGN: A double blind, randomised controlled trial using 40 hospital referred patients with CMCJ osteoarthritis who received intra-articular injections of 5 mg triamcinolone hexacetonide (0.25 ml) or sterile 0.9% saline (0.25 ml). Injections were given under imaging control. MAIN OUTCOME MEASURES: The primary outcome was improvement in a pain visual analogue score (VAS) of 20% at 24 weeks. In addition patients were assessed at 4, 12, and 24 weeks for joint stiffness, joint tenderness, and physician and patient global assessments. Hand radiographs were evaluated for the degree of CMC joint space narrowing and marginal osteophytes according to the OARSI atlas. RESULTS: Baseline clinical variables were not significantly different between the two treatment groups. There was no improvement in the VAS of pain at 24 weeks. At each assessment point there was no significant difference between the steroid and placebo groups in median values for joint stiffness, joint tenderness, or patient and physician global assessments. Non-parametric analysis of each group individually revealed statistically significant improvements in patient and physician global assessments at weeks 4, 12, and 24 in the placebo group and at weeks 4 and 12 in the steroid group. CONCLUSIONS: No clinical benefit was gained from intra-articular steroid injection to the CMCJ in moderate to severe osteoarthritis compared with placebo injection.

Adult↗

PubMed1992

Randomised controlled trial of effects of coordinating care for terminally ill cancer patients.

OBJECTIVES: To measure effects on terminally ill cancer patients and their families of coordinating the services available within the NHS and from local authorities and the voluntary sector. DESIGN: Randomised controlled trial. SETTING: Inner London health district. PATIENTS: Cancer patients were routinely notified from 1987 to 1990. 554 patients expected to survive less than one year entered the trial and were randomly allocated to a coordination or a control group. INTERVENTION: All patients received routinely available services. Coordination group patients received the assistance of two nurse coordinators, whose role was to ensure that patients received appropriate and well coordinated services, tailored to their individual needs and circumstances. MAIN OUTCOME MEASURES: Patients and carers were interviewed at home on entry to the trial and at intervals until death. Interviews after bereavement were also conducted. Outcome measures included the presence and severity of physical symptoms, psychiatric morbidity, use of and satisfaction with services, and carers' problems. Results from the baseline interview, the interview closest to death, and the interview after bereavement were analysed. RESULTS: Few differences between groups were significant. Coordination group patients were less likely to suffer from vomiting, were more likely to report effective treatment for it, and less likely to be concerned about having an itchy skin. Their carers were more likely to report that in the last week of life the patient had had a cough and had had effective treatment for constipation, and they were less likely to rate the patient's difficulty swallowing as severe or to report effective treatment for anxiety. Coordination group patients were more likely to have seen a chiropodist and their carers were more likely to contact a specialist nurse in a night time emergency. These carers were less likely to feel angry about the death of the patient. CONCLUSIONS: This coordinating service made little difference to patient or family outcomes, perhaps because the service did not have a budget with which it could obtain services or because the professional skills of the nurse-coordinators may have conflicted with the requirements of the coordinating role.

Anxiety↗

PubMed1998

Randomised controlled trial of two models of care for discharged psychiatric patients.

OBJECTIVE: To compare the clinical outcome and costs of care of psychiatric patients allocated to community multidisciplinary teams or to hospital based care programmes after discharge from inpatient care. DESIGN: Randomised controlled trial. SETTING: Inner London (Paddington and North Kensington) and outer London (Brent) psychiatric services. SUBJECTS: 155 patients with severe mental illness with a previous admission within the past 2 years. MAIN OUTCOME MEASURES: Ratings of clinical psychopathology, depression, anxiety, and social functioning; comprehensive costs of health care. RESULTS: Clinical outcomes were available for 133 patients and cost data for 144 patients after 1 year. The clinical outcomes of the two models of care were essentially similar, but admission to hospital was more likely in the hospital based care group and the costs of health care were 14% greater per patient than in the community group. This difference, however, was dwarfed by a twofold difference in the costs of care in the outer London services compared with those in inner London. This was explained largely by greater inpatient care for outer London patients (58 median bed days v 18 for inner London patients), more of which was provided by extracontractual referrals to other psychiatric hospitals as Brent had only 0.28/1000 beds available for acute adult patients compared with 0.82/1000 in Paddington and North Kensington over the period of the study. CONCLUSION: Aftercare by community teams for psychiatric patients with severe mental illness has a similar outcome to hospital based aftercare but with fewer admissions to hospital. When psychiatric bed requirements are insufficient for a population, however, neither form of aftercare is effective as greater use of hospital beds elsewhere swamps any advantage of community care programmes, with disintegration and discontinuity of psychiatric services leading to escalating costs.

Adolescent↗

PubMed1998

Randomised controlled trial of the READER method of critical appraisal in general practice.

OBJECTIVE: To evaluate the READER model for critical reading by comparing it with a free appraisal, and to explore what factors influence different components of the model. DESIGN: A randomised controlled trial in which two groups of general practitioners assessed three papers from the general practice section of the BMJ. SETTING: Northern Ireland. SUBJECTS: 243 general practitioners. MAIN OUTCOME MEASURES: Scores given using the READER model (Relevance, Education, Applicability, Discrimination, overall Evaluation) and scores given using a free appraisal for scientific quality and an overall total. RESULTS: The hierarchical order for the three papers was different for the two groups, according to the total scores. Participants using the READER method (intervention group) gave a significantly lower total score (P < or = 0.01) and a lower score for the scientific quality (P < or = 0.0001) for all three papers. Overall more than one in five (22%), and more men than women, read more than 5 articles a month (P < or = 0.05). Those who were trainers tended to read more articles (P < or = 0.05), and no trainers admitted to reading none. Overall, 58% (135/234) (68% (76/112) of the intervention group) believed that taking part in the exercise would encourage them to be more critical of published articles in the future (P < or = 0.01). CONCLUSION: Participants using the READER model gave a consistently lower overall score and applied a more appropriate appraisal to the methodology of the studies. The method was both accurate and repeatable. No intrinsic factors influenced the scores, so the model is appropriate for use by all general practitioners regardless of their seniority, location, teaching or training experience, and the number of articles they read regularly.

Education, Medical, Continuing↗

PubMed2000

Cost analysis of nurse telephone consultation in out of hours primary care: evidence from a randomised controlled trial.

OBJECTIVE: To undertake an economic evaluation of nurse telephone consultation using decision support software in comparison with usual general practice care provided by a general practice cooperative. DESIGN: Cost analysis from an NHS perspective using stochastic data from a randomised controlled trial. SETTING: General practice cooperative with 55 general practitioners serving 97 000 registered patients in Wiltshire, England. SUBJECTS: All patients contacting the service, or about whom the service was contacted during the trial year (January 1997 to January 1998). MAIN OUTCOME MEASURES: Costs and savings to the NHS during the trial year. RESULTS: The cost of providing nurse telephone consultation was 81 237 pound sterling per annum. This, however, determined a 94 422 pound sterling reduction of other costs for the NHS arising from reduced emergency admissions to hospital. Using point estimates for savings, the cost analysis, combined with the analysis of outcomes, showed a dominance situation for the intervention over general practice cooperative care alone. If a larger improvement in outcomes is assumed (upper 95% confidence limit) NHS savings increase to 123 824 pound sterling per annum. Savings of only 3728 pound sterling would, however, arise in a scenario where lower 95% confidence limits for outcome differences were observed. To break even, the intervention would have needed to save 138 emergency hospital admissions per year, around 90% of the effect achieved in the trial. Additional savings of 16 928 pound sterling for general practice arose from reduced travel to visit patients at home and fewer surgery appointments within three days of a call. CONCLUSIONS: Nurse telephone consultation in out of hours primary care may reduce NHS costs in the long term by reducing demand for emergency admission to hospital. General practitioners currently bear most of the cost of nurse telephone consultation and benefit least from the savings associated with it. This indicates that the service produces benefits in terms of service quality, which are beyond the reach of this cost analysis.

Acute Disease↗

PubMed2001

Pragmatic randomised controlled trial to evaluate guidelines for the management of infertility across the primary care-secondary care interface.

OBJECTIVE: To investigate the effect of clinical guidelines on the management of infertility across the primary care-secondary care interface. DESIGN: Cluster randomised controlled trial. SETTING: General practices and NHS hospitals accepting referrals for infertility in the Greater Glasgow Health Board area. PARTICIPANTS: All 221 general practices in Glasgow; 214 completed the trial. INTERVENTION: General practices in the intervention arm received clinical guidelines developed locally. Control practices received them one year later. Dissemination of the guidelines included educational meetings. MAIN OUTCOME MEASURES: The time from presentation to referral, investigations completed in general practice, the number and content of visits as a hospital outpatient, the time to reach a management plan, and costs for referrals from the two groups. RESULTS: Data on 689 referrals were collected. No significant difference was found in referral rates for infertility. Fewer than 1% of couples were referred inappropriately early. Referrals from intervention practices were significantly more likely to have all relevant investigations carried out (odds ratio 1.32, 95% confidence interval 1.00 to 1.75, P=0.025). 70% of measurements of serum progesterone concentrations during the midluteal phase and 34% of semen analyses were repeated at least once in hospital, despite having been recorded as normal when checked in general practice. No difference was found in the proportion of referrals in which a management plan was reached within one year or in the mean duration between first appointment and date of management plan. NHS costs were not significantly affected. CONCLUSIONS: Dissemination of infertility guidelines by commonly used methods results in a modest increase in referrals having recommended investigations completed in general practice, but there are no detectable differences in outcome for patients or reduction in costs. Clinicians in secondary care tended to fail to respond to changes in referral practice by doctors. Guidelines that aim to improve the referral process need to be disseminated and implemented so as to lead to changes in both primary care and secondary care.

Cost-Benefit Analysis↗

PubMed2001

Cluster randomised controlled trial to compare three methods of promoting secondary prevention of coronary heart disease in primary care.

OBJECTIVE: To assess the effectiveness of three different methods of promoting secondary prevention of coronary heart disease in primary care. DESIGN: Pragmatic, unblinded, cluster randomised controlled trial. SETTING: Warwickshire. SUBJECTS: 21 general practices received intervention; outcome measured in 1906 patients aged 55-75 years with established coronary heart disease. INTERVENTIONS: Audit of notes with summary feedback to primary health care team (audit group); assistance with setting up a disease register and systematic recall of patients to general practitioner (GP recall group); assistance with setting up a disease register and systematic recall of patients to a nurse led clinic (nurse recall group). MAIN OUTCOME MEASURES: At 18 months' follow up: adequate assessment (defined) of 3 risk factors (blood pressure, cholesterol, and smoking status); prescribing of hypotensive agents, lipid lowering drugs, and antiplatelet drugs; blood pressure, serum cholesterol level, and plasma cotinine levels. RESULTS: Adequate assessment of all 3 risk factors was much more common in the nurse and GP recall groups (85%, 76%) than the audit group (52%). The advantage in the nurse recall compared with the audit group was 33% (95% confidence interval 19% to 46%); in the GP recall group compared with the audit group 23% (10% to 36%), and in the nurse recall group compared with the GP recall group 9% (-3% to 22%). However, these differences in assessment were not reflected in clinical outcomes. Mean blood pressure (148/80, 147/81, 148/81 mm Hg), total cholesterol (5.4, 5.5, 5.5 mmol/l), and cotinine levels (% probable smokers 17%, 16%, 19%) varied little between the nurse recall, GP recall, and audit groups respectively, as did prescribing of hypotensive and lipid lowering agents. Prescribing of antiplatelet drugs was higher in the nurse recall group (85%) than the GP recall or audit groups (80%, 74%). After adjustment for baseline levels, the advantage in the nurse recall group compared with the audit group was 10% (3% to 17%), in the nurse recall group compared with the GP recall group 8% (1% to 15%) and in the GP recall group compared with the audit group 2% (-6% to 10%). CONCLUSIONS: Setting up a register and recall system improved patient assessment at 18 months' follow up but was not consistently better than audit alone in improving treatment or risk factor levels. Understanding the reasons for this is the key next step in improving the quality of care of patients with coronary heart disease.

Aged↗

PubMed2004

NHS Direct versus general practice based triage for same day appointments in primary care: cluster randomised controlled trial.

OBJECTIVE: To assess the relative effects on consultation workload and costs of off-site triage by NHS Direct for patients requesting same day appointments compared with usual on-site nurse telephone triage in general practice. DESIGN: Cluster randomised controlled trial. SETTING: Three primary care sites in York, England. PARTICIPANTS: 4703 patients: 2452 with practice based triage, 2251 with NHS Direct triage. All consecutive patients making requests for same day appointments during study weeks were eligible for the trial. MAIN OUTCOME MEASURES: Type of consultation after request for same day appointment (telephone, appointment, or visit); time taken for consultation; service use during the month after same day contact; costs of same day, follow up, and emergency care. RESULTS: Patients in the NHS Direct group were less likely to have their call resolved by a nurse and were more likely to have an appointment with a general practitioner. Mean total time per patient in the NHS Direct group was 7.62 minutes longer than in the practice based group. Costs were greater in the NHS Direct group--2.88 pounds sterling (0.88 pounds sterling to 4.87 pounds sterling) per patient triaged--as a result of the difference between the groups in proportions of patients at each final point contact after triage. CONCLUSIONS: External management of requests for same day appointments by nurse telephone triage through NHS Direct is possible but comes at a higher cost than practice nurse delivered triage in primary care. If NHS Direct could achieve the same proportions of consultation types as practice based triage, costs would be comparable.

Adolescent↗

PubMed2006

Effects of psychosocial stimulation and dietary supplementation in early childhood on psychosocial functioning in late adolescence: follow-up of randomised controlled trial.

OBJECTIVE: To determine whether dietary supplementation or psychosocial stimulation given to growth retarded (stunted) children age 9-24 months has long term benefits for their psychosocial functioning in late adolescence. DESIGN: Sixteen year follow-up study of a randomised controlled trial. SETTING: Poor neighbourhoods in Kingston, Jamaica. PARTICIPANTS: Of 129 stunted children identified at age 9-24 months, 103 adolescents aged 17-18 were followed up. INTERVENTION: Supplementation with 1 kg milk based formula each week or psychosocial stimulation (weekly play sessions with mother and child), or both, for two years. MAIN OUTCOME MEASURES: Anxiety, depression, self esteem, and antisocial behaviour assessed by questionnaires administered by interviewers; attention deficit, hyperactivity, and oppositional behaviour assessed by interviews with parents. RESULTS: Primary analysis indicated that participants who received stimulation had significantly different overall scores from those who did not (F = 2.047, P = 0.049). Supplementation had no significant effect (F = 1.505, P = 0.17). Participants who received stimulation reported less anxiety (mean difference - 2.81, 95% confidence interval - 5.02 to - 0.61), less depression (- 0.43, - 0.78 to - 0.07), and higher self esteem (1.55, 0.08 to 3.02) and parents reported fewer attention problems (- 3.34, - 6.48 to - 0.19). These differences are equivalent to effect sizes of 0.40-0.49 standard deviations. CONCLUSIONS: Stimulation in early childhood has sustained benefits to stunted children's emotional outcomes and attention.

Adolescent↗

PubMed2001

Nurse led shared care for patients on the waiting list for coronary artery bypass surgery: a randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of a nurse led shared care programme to improve coronary heart disease risk factor levels and general health status and to reduce anxiety and depression in patients awaiting coronary artery bypass grafting (CABG). DESIGN: Randomised controlled trial. SETTING: Community, January 1997 to March 1998. STUDY GROUPS: 98 (75 male) consecutive patients were recruited to the study within one month of joining the waiting list for elective CABG at Glasgow Royal Infirmary University NHS Trust. Patients were randomly assigned to usual care (control; n = 49) or a nurse led intervention programme (n = 49). INTERVENTION: A shared care programme consisting of health education and motivational interviews, according to individual need, was carried out monthly. Care was provided in the patients' own homes by the community based cardiac liaison nurse alternating with the general practice nurse at the practice clinic. OUTCOME MEASURES: Smoking status, obesity, physical activity, anxiety and depression, general health status, and proportion of patients exceeding target values for blood pressure, plasma cholesterol, and alcohol intake. RESULTS: Compared with patients who received usual care, those participating in the nurse led programme were more likely to stop smoking (25% v 2%, p = 0.001) and to reduce obesity (body mass index > 30 kg/m(2)) (16.3% v 8.1%, p = 0.01). Target systolic blood pressure improved by 19.8% compared with a 10.7% decrease in the control group (p = 0.001) and target diastolic blood pressure improved by 21.5% compared with 10.2% in the control group (p = 0.000). However, there was no significant difference between groups in the proportion of patients with cholesterol concentrations exceeding target values. There was a significant improvement in general health status scores across all eight domains of the 36 item short form health survey with changes in difference in mean scores between the groups ranging from 8.1 (p = 0.005) to 36.1 (p < 0.000). Levels of anxiety and depression improved (p < 0.000) and there was improvement in time spent being physically active (p < 0.000). CONCLUSIONS: This nurse led shared care intervention was shown to be effective for improving care for patients on the waiting list for CABG.

Adult↗