SEARCH · PubMed Health

Results for “Randomised Controlled Trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 577 records · Page 32Linked to original sources

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↗

PubMed2006

Joint crisis plans for people with psychosis: economic evaluation of a randomised controlled trial.

OBJECTIVE: To investigate the cost effectiveness of joint crisis plans, a form of advance agreement for people with severe mental illness. DESIGN: Single blind randomised controlled trial. SETTING: Eight community mental health teams in southern England. PARTICIPANTS: 160 people with a diagnosis of psychotic illness or non-psychotic bipolar disorder who had been admitted to hospital at least once within the previous two years. INTERVENTION: Joint crisis plan formulated by the patient, care coordinator, psychiatrist, and project worker containing contact information, details of illnesses, treatments, relapse indicators, and advance statements of preferences for care for future relapses. Control group was standardised service information. MAIN OUTCOME MEASURES: Admission to hospital; service use over 15 months. RESULTS: Use of a joint crisis plan was associated with less service use and lower costs on average than in the standardised service information group, but differences were not significant. Total costs during follow-up were 7264 pounds sterling (10,616 euros, 13,560 dollars) for each participant with a joint crisis plan and 8359 pounds sterling (12,217 euros, 15,609 dollars) for each participant with standardised service information (mean difference 1095 pounds sterling; 95% confidence interval -2814 to 5004). Cost effectiveness acceptability curves, used to explore uncertainty in estimates of costs and effects, suggest there is a greater than 78% probability that joint crisis plans are more cost effective than standardised service information in reducing the proportion of patients admitted to hospital. CONCLUSION: Joint crisis plans produced a non-significant decrease in admissions and total costs. Though the cost estimates had wide confidence intervals, the associated uncertainty suggests there is a relatively high probability of the plans being more cost effective than standardised service information for people with psychotic disorders.

Community Mental Health Services↗

PubMed1989

Randomised controlled trial of interferon alfa 2A (rbe) (Roferon-A) for the treatment of chronic hepatitis B virus (HBV) infection: factors that influence response.

In a randomised controlled trial recombinant interferon alpha 2A (Roferon-A, rIFN alfa A) given at a dosage of 10 million units (MU)/m2 thrice weekly for six months was significantly better (p less than 0.02) than no treatment in producing a sustained loss of hepatitis Be antigen (HBeAg) in hepatitis B virus (HBV) chronic carriers. Although lower doses (5 MU/m2 and 2.5 MU/m2) also produced some responses, the seroconversion rate was not significantly greater than that observed in the control group. Sixteen of the 45 patients receiving interferon were human immunodeficiency virus (HIV) antibody positive: none of these responded. Forty one per cent of the anti-HIV negative patients receiving interferon (12/29, p less than 0.005) lost HBeAg and 17% (5/29) lost hepatitis B surface antigen (HBsAg). The response rate among these anti-HIV negative patients receiving at least three months therapy was 46% and 19% respectively. Low pretreatment HBV-DNA and absence of anti-HIV were the only significant independent variables predicting response to therapy (p less than 0.03 and p less than 0.05 respectively). In six patients, neutralising antibodies to alpha interferon were detected during therapy, the majority being non-responders.

Adult↗

PubMed2001

Who's afraid of the randomised controlled trial? Parents' views of an SLT research study.

Evidence-based health care is now a reality within the national health service (NHS) and the randomised controlled trial (RCT) is the linchpin of this movement. In modern health care, there has also been a shift towards understanding client perspectives. With regard to clients' participation in research, much consideration has been given to ethical issues and barriers to participation. However, less attention has been paid to the participants' views of clinical trials and understanding how they construe the research. This paper reports a study of the attitudes of parents whose children took part in an RCT. Data were collected from the parents of 20 children, using qualitative in-depth interviews. Parents talked about the meaning of their participation, their motivation for taking part and their understanding of the nature of the trial. The implications of the findings for future research will be considered.

Attitude↗

PubMed1992

Antenatal care of low risk obstetric patients by midwives. A randomised controlled trial.

OBJECTIVES: To assess the practicality, acceptability to patients and salary costs of the antenatal care of low risk obstetric patients by midwives. DESIGN: A randomised controlled trial. SETTING: The antenatal clinic at Westmead Hospital, a teaching hospital of the University of Sydney in western Sydney. PATIENTS: From January 1989 until November 1990, 89 women booking for full antenatal care at Westmead Hospital and classified as low risk were randomly allocated to one of two groups. Group 1 (43 patients) had their antenatal care provided by registered midwives. Group 2 (46 patients) had their antenatal care provided by an obstetrician (either Visiting Medical Officer or Staff Specialist) in a routine hospital antenatal clinic. INTERVENTIONS: Patients in the midwives' clinic were seen by an obstetrician at their first visit to the antenatal clinic and again at 30 weeks and at 40 weeks. MAIN OUTCOME MEASURES: These were the salary costs of each clinic and the patients' levels of satisfaction. Maternal and neonatal indicators, delivery details and analgesic requirements were also considered. These indicators were planned before data collection commenced. RESULTS: The major differences found were a 28% to 68% salary cost saving and that patients cared for by midwives showed appreciation of the continuity of care and information given at the midwives' clinic. CONCLUSIONS: The care of low risk obstetric patients by midwives in a midwives' clinic showed salary cost savings and high patient acceptance.

Continuity of Patient Care↗

PubMed2006

The effects of a team-based continuous quality improvement intervention on the management of primary care: a randomised controlled trial.

AIM: To study the effects of a team-based model for continuous quality improvement (CQI) on primary care practice management. DESIGN OF STUDY: Randomised controlled trial. SETTING: Twenty-six intervention and 23 control primary care practices in the Netherlands. METHOD: Practices interested in taking part in the CQI project were, after assessment of their practice organisation, randomly assigned to the intervention or control groups. During a total of five meetings, a facilitator helped the teams in the intervention group select suitable topics for quality improvement and follow a structured approach to achieve improvement objectives. Checklists completed by an outreach visitor, questionnaires for the GPs, staff and patients were used to assemble data on the number and quality of improvement activities undertaken and on practice management prior to the start of the intervention and 1 year later. RESULTS: Pre-test and post-test data were compared for the 26 intervention and 23 control practices. A significant intervention effect was found for the number of improvement objectives actually defined (93 versus 54, P<0.001) and successfully completed (80 versus 69% of the projects, P<0.001). The intervention group also improved on more aspects of practice management, as measured by our practice visit method, than the control group but none of these differences proved statistically significant. CONCLUSION: The intervention exerted a significant effect on the number and quality of improvement projects undertaken and self-defined objectives met. Failure of the effects of the intervention on the other dimensions of practice management to achieve significance may be due to the topics selected for some of the improvement projects being only partly covered by the assessment instrument.

Family Practice↗

PubMed2005

Evaluation of a general practitioner with special interest service for dermatology: randomised controlled trial.

OBJECTIVE: To assess the effectiveness, accessibility, and acceptability of a general practitioner with special interest service for skin problems compared with a hospital dermatology clinic. DESIGN: Randomised controlled trial. SETTING: General practitioner with special interest dermatology service and hospital dermatology clinic. PARTICIPANTS: Adults referred to a hospital dermatology clinic and assessed by a consultant or the general practitioner with special interest service,. Suitable patients had non-urgent skin problems and had been identified from the referral letter as suitable for management by a general practitioner with special interest. INTERVENTIONS: Participants were randomised in 2:1 ratio to receive management by a general practitioner with special interest or usual hospital outpatient care. MAIN OUTCOME MEASURES: Primary outcomes were disease related quality of life (dermatology life quality index) and improvement in patients' perception of access to services, assessed nine months after randomisation. Secondary outcomes were patient satisfaction, preference for site of care, proportion of failed appointments, and waiting times to first appointment. RESULTS: 49% of the participants were judged suitable for care by the general practitioner with special interest service. Of 768 patients eligible, 556 (72.4%) were randomised (354 to general practitioner with special interest, 202 to hospital outpatient care). After nine months, 422 (76%) were followed up. No noticeable differences were found between the groups in clinical outcome (median dermatology life quality index score = 1 both arms, ratio of geometric means 0.99, 95% confidence interval 0.85 to 1.15). The general practitioner with special interest service was more accessible (difference between means on access scale 14, 11 to 19) and waited a mean of 40 (35 to 46) days less. Patients expressed slightly greater satisfaction with consultations with a general practitioner with special interest (difference in mean satisfaction score 4, 1 to 7), and at baseline and after nine months 61% said they preferred care at the service. CONCLUSIONS: The general practitioner with special interest service for dermatology was more accessible and preferred by patients than hospital outpatient care, achieving similar clinical outcomes. Trial registration ISRCTN31962758.

Adolescent↗

PubMed2003

Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials.

OBJECTIVE: To determine whether supervised medical prescription of heroin can successfully treat addicts who do not sufficiently benefit from methadone maintenance treatment. DESIGN: Two open label randomised controlled trials. SETTING: Methadone maintenance programmes in six cities in the Netherlands. PARTICIPANTS: 549 heroin addicts. INTERVENTIONS: Inhalable heroin (n = 375) or injectable heroin (n = 174) prescribed over 12 months. Heroin (maximum 1000 mg per day) plus methadone (maximum 150 mg per day) compared with methadone alone (maximum 150 mg per day). Psychosocial treatment was offered throughout. MAIN OUTCOME MEASURES: Dichotomous, multidomain response index, including validated indicators of physical health, mental status, and social functioning. RESULTS: Adherence was excellent with 12 month outcome data available for 94% of the randomised participants. With intention to treat analysis, 12 month treatment with heroin plus methadone was significantly more effective than treatment with methadone alone in the trial of inhalable heroin (response rate 49.7% v 26.9%; difference 22.8%, 95% confidence interval 11.0% to 34.6%) and in the trial of injectable heroin (55.5% v 31.2%; difference 24.3%, 9.6% to 39.0%). Discontinuation of the coprescribed heroin resulted in a rapid deterioration in 82% (94/115) of those who responded to the coprescribed heroin. The incidence of serious adverse events was similar across treatment conditions. CONCLUSIONS: Supervised coprescription of heroin is feasible, more effective, and probably as safe as methadone alone in reducing the many physical, mental, and social problems of treatment resistant heroin addicts.

Adult↗

PubMed2002

Assessment of neurocognitive impairment after off-pump and on-pump techniques for coronary artery bypass graft surgery: prospective randomised controlled trial.

OBJECTIVE: To assess neurocognitive impairment after the off-pump and on-pump techniques for coronary artery bypass graft surgery in patients with triple vessel disease. DESIGN: Randomised controlled trial. SETTING: University Hospital of Wales, Cardiff. PARTICIPANTS: 60 patients undergoing coronary artery bypass graft surgery for triple vessel disease prospectively randomised to the off-pump or on-pump technique. MAIN OUTCOME MEASURES: Change in scores in nine standard neuropsychometric tests administered preoperatively and at 1 and 10 weeks postoperatively. RESULTS: The on-pump group showed a significantly greater deterioration in scores for two and three tests at 1 week and 10 weeks postoperatively, respectively, than the off-pump group. The on-pump group also showed a significantly higher incidence of major deterioration in one of the tests both 1 week and 10 weeks postoperatively. The incidence of neurocognitive impairment at 1 week postoperatively was 27% (8 out of 30) in the off-pump group and 63% (19 out of 30) in the on-pump group (P=0.004); and at 10 weeks postoperatively was 10% (3 out of 30) in the off-pump group and 40% (12 out of 30) in the on-pump group (P=0.017). CONCLUSION: Off-pump coronary artery bypass graft surgery results in less neurocognitive impairment than the on-pump technique.

Cognition Disorders↗

PubMed2002

Preventing anxiety and depression in gynaecological cancer: a randomised controlled trial.

OBJECTIVE: To examine the effect of counselling and relaxation intervention on psychological symptoms in patients with gynaecological cancer between the post-operative period and the six-week review. DESIGN: Randomised controlled trial. PARTICIPANTS: Fifty-three patients with gynaecological cancer. SETTING: Three Australian tertiary referral hospitals. METHODS: Fifty-three patients were randomised to control or intervention and completed the baseline Hospital Anxiety and Depression Scale (HADS) and General Health Questionnaire-28 (GHQ-28) questionnaires. The intervention consisted of a relaxation and counselling session performed by a senior doctor. Follow up questionnaires were completed at six weeks. Demographic and tumour data were collated independently. RESULTS: Complete data were available on 50 patients. There were no significant differences in demographic, social support or tumour characteristics between the two groups. Multivariate analysis determined that only the intervention and baseline score were significant predictors of outcome. The intervention was associated with a significant reduction in total HADS score (P = 0.002). The reduction was seen in both anxiety and moderate depression subscales (P = 0.001 and P = 0.02). The intervention was also associated with a significant reduction in total GHQ-28 score and in three of the four subscale scores (somatisation, anxiety and personality development; all P < 0.02). However, no significant difference was found in the fourth subscale of major depression. CONCLUSION: A relaxation and counselling intervention performed by a treating doctor reduces psychological symptoms in women with a new diagnosis of gynaecological cancer.

Anxiety Disorders↗

PubMed1997

Satisfaction and the three C's: continuity, choice and control. Women's views from a randomised controlled trial of midwife-led care.

OBJECTIVE: 1. To explore whether there are differences in women's satisfaction with care in a midwife-managed delivery unit compared with that in a consultant-led labour ward. 2. To compare factors relating to continuity, choice and control between the two randomised groups. DESIGN: A pragmatic randomised controlled trial. SETTING: Aberdeen Maternity Hospital, Grampian. SAMPLE: 2844 women, identified at booking as low risk, were randomised in a 2:1 ratio between the midwives' unit and the labour ward. MAIN OUTCOME MEASURES: Satisfaction, continuity of carer, choice, and control. RESULTS: Satisfaction with the overall experience did not differ between the groups. Satisfaction with how labour and delivery was managed by staff was slightly higher in the midwives' unit group, but this did not reach the 0.1% level of significance. Women allocated to the midwives' unit group saw significantly fewer medical staff and were less likely to report numerous individuals entering the room. They were more likely to report having had a choice regarding mobility and alternative positions for delivery and were significantly more likely to have made their own decisions regarding pain relief. CONCLUSIONS: The issues surrounding the measurement of satisfaction with childbirth need further investigation. Until this area is clarified it would be unwise to use an overall measure of satisfaction as an indicator of the quality of maternity service provision. In particular, the current measures are not sensitive enough to examine the specific factors which affect women's satisfaction. Further research is required to assess which factors are important to women if they are to have a positive experience of childbirth and how these priorities change over time.

Adult↗

PubMed2005

Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial.

BACKGROUND: The treatment of rest pain, ulceration, and gangrene of the leg (severe limb ischaemia) remains controversial. We instigated the BASIL trial to compare the outcome of bypass surgery and balloon angioplasty in such patients. METHODS: We randomly assigned 452 patients, who presented to 27 UK hospitals with severe limb ischaemia due to infra-inguinal disease, to receive a surgery-first (n=228) or an angioplasty-first (n=224) strategy. The primary endpoint was amputation (of trial leg) free survival. Analysis was by intention to treat. The BASIL trial is registered with the National Research Register (NRR) and as an International Standard Randomised Controlled Trial, number ISRCTN45398889. FINDINGS: The trial ran for 5.5 years, and follow-up finished when patients reached an endpoint (amputation of trial leg above the ankle or death). Seven individuals were lost to follow-up after randomisation (three assigned angioplasty, two surgery); of these, three were lost (one angioplasty, two surgery) during the first year of follow-up. 195 (86%) of 228 patients assigned to bypass surgery and 216 (96%) of 224 to balloon angioplasty underwent an attempt at their allocated intervention at a median (IQR) of 6 (3-16) and 6 (2-20) days after randomisation, respectively. At the end of follow-up, 248 (55%) patients were alive without amputation (of trial leg), 38 (8%) alive with amputation, 36 (8%) dead after amputation, and 130 (29%) dead without amputation. After 6 months, the two strategies did not differ significantly in amputation-free survival (48 vs 60 patients; unadjusted hazard ratio 1.07, 95% CI 0.72-1.6; adjusted hazard ratio 0.73, 0.49-1.07). We saw no difference in health-related quality of life between the two strategies, but for the first year the hospital costs associated with a surgery-first strategy were about one third higher than those with an angioplasty-first strategy. INTERPRETATION: In patients presenting with severe limb ischaemia due to infra-inguinal disease and who are suitable for surgery and angioplasty, a bypass-surgery-first and a balloon-angioplasty-first strategy are associated with broadly similar outcomes in terms of amputation-free survival, and in the short-term, surgery is more expensive than angioplasty.

Aged↗

PubMed2006

Sleep-disordered breathing after stroke: a randomised controlled trial of continuous positive airway pressure.

BACKGROUND: Sleep-disordered breathing (SDB) is common after stroke, but it is unclear whether it should be treated. OBJECTIVE: To conduct a randomised controlled trial of continuous positive airway pressure (CPAP) after stroke. METHODS: Patients with stroke with > or = 30 apnoeas and hypopnoeas per hour ((A+H)/h) with predominant obstructive sleep apnoea or hypopnoea were randomised to either CPAP treatment or conservative treatment for 8 weeks. Outcomes were measured blind to treatment allocation at 8 weeks and 6 months after the stroke. The primary outcome was physical function on the Nottingham Extended Activities of Daily Living Scale. RESULTS: Of 658 patients with stroke screened, only 71 (10.7%) were eligible and consented to a sleep study 14-19 days after stroke. 66 patients completed the sleep study (21 women; mean age 72 years), 33 (50%) had > or = 30 (A+H)/h that were predominantly obstructive. 15 were randomised to CPAP treatment and 15 to conventional treatment. Despite intensive efforts, objective use of CPAP was poor, averaging 1.4 h a night. CPAP treatment resulted in no significant improvements (p>0.1) in the primary outcome or in neurological function or sleepiness, and in poorer health status on some measures. CONCLUSIONS: This trial showed no benefit from CPAP treatment, the relevance of the observed detrimental effects is questionable. Even in our highly selected patients with stroke, use of CPAP was poor. At present, CPAP treatment should be advocated for patients with stroke only if they have symptoms of SDB.

Activities of Daily Living↗

PubMed1995

UKCCCR multicentre randomised controlled trial of one and two view mammography in breast cancer screening.

OBJECTIVE: To compare one view (oblique) and two view (oblique and craniocaudal) mammography in breast cancer screening. DESIGN: Randomised controlled trial. SETTING: Nine breast screening centres in England. SUBJECTS: 40,163 women aged 50-64 attending their first breast screening examination. INTERVENTIONS: Women were randomised to have one view mammography, two view mammography, or two view mammography in which one view was read by one reader and both views were read by another. MAIN OUTCOME MEASURES: Prevalence of cancer detected, recall rates, cost per cancer detected, and marginal cost per extra cancer detected. RESULTS: Two view mammography detected 24% more women with breast cancer (95% confidence interval 16% to 31%) than one view mammography. Prevalence of detected cancer was 6.84 with two view mammography and 5.52 per 1000 women with one view. The proportion of women recalled for assessment was 15% lower (95% confidence interval 6% to 23%) with two view (6.97%) than with one view (8.16%) mammography. The cost of two view screening was higher (26.46 pounds compared with 22.00 pounds per examination) but the average cost per cancer detected was similar (5330 pounds compared with 5310 pounds) and the marginal cost per extra cancer detected with two views was similar to the average cost (5400 pounds). CONCLUSION: Two view mammography is medically more effective than one view; it detects more cancers and reduces recall rates; it is also similarly cost effective financially.

Breast Neoplasms↗

PubMed1997

Randomised controlled trial of inhaled corticosteroids (fluticasone propionate) in cystic fibrosis.

BACKGROUND: Controlling lung inflammation may be the key to improving morbidity and mortality in cystic fibrosis. OBJECTIVE: To assess the effects of inhaled corticosteroids on lung inflammation in cystic fibrosis. DESIGN: Double blind placebo controlled randomised sequence crossover trial. Fluticasone propionate (400 micrograms/day) was given as a dry powder inhaler for six weeks with a four week washout period before crossover. OUTCOME MEASURES: Sputum inflammatory markers (interleukin-8, tumour necrosis factor-alpha (TNF-alpha) and neutrophil elastase-both free and bound to alpha 1-antiprotease), sputum interleukin-10, lung function, and symptomatology. SUBJECTS: Twenty three children from a regional cystic fibrosis centre were enrolled into the study, with mean age 10.3 years (range 7 to 17 years) and mean baseline forced expiratory volume in one second (FEV1) of 64% (range 21% to 102%) predicted for sex and height. One patient was excluded for non-compliance to the study protocol. RESULTS: No significant benefit was shown for the use of fluticasone propionate in any of the outcomes. For sputum interleukin-8 there was an estimated true treatment median difference of 142 pg/ml (95% confidence interval (CI) 8 to 2866 pg/ml) in favour of placebo; while for maximal expiratory flow at 25% (MEF25%) remaining forced vital capacity predicted for sex and height there was a 15 percentage points (pp) (95% CI 4 to 26 pp) mean treatment difference in favour of placebo. Sputum interleukin-10 was undetected in any samples and unaffected by fluticasone propionate. Neither atopic status, baseline FEV1, nor concomitant DNase therapy had any effect on response to treatment. CONCLUSIONS: Lack of benefit from fluticasone propionate was most likely due to failure of the drug to penetrate the viscid mucus lining the airways. It is suggested a large multicentre trial with higher doses given for a longer time by a different delivery system is required to assess efficacy.

Administration, Inhalation↗

PubMed2005

Recruitment and implementation strategies in randomised controlled trials of acupuncture and herbal medicine in women's health.

INTRODUCTION: Recruitment of subjects to clinical trials is known to be difficult and there is little research describing recruitment and implementation strategies to CAM clinical trials. This paper describes the experiences from recruitment and implementation for five randomised controlled trials in women's health conducted in South Australia. METHODS: Descriptive study reporting on trial documentation and questionnaires completed by women. RESULTS: Recruitment rates varied between trials and a variety of recruitment strategies were used between studies. Promotion of the trials to the wider community were facilitated by issuing press releases and subsequent reporting by the media. Women found the trial acceptable suggesting factors motivating and preventing women from participating were well addressed. CONCLUSION: It is hoped that the experiences described here will give some insight to recruitment and implementation strategies. There is a need for more systematic research and evaluation of these strategies, and dissemination of these findings to assist with successful implementation of trials.

Acupuncture Therapy↗

PubMed2003

Accessibility, acceptability, and effectiveness in primary care of routine telephone review of asthma: pragmatic, randomised controlled trial.

OBJECTIVE: To determine whether routine review by telephone of patients with asthma improves access and is a good alternative to face to face reviews in general practices. DESIGN: Pragmatic, randomised controlled trial. SETTING: Four general practices in England. PARTICIPANTS: 278 adults who had not been reviewed in the previous 11 months. INTERVENTION: Participants were randomised to either telephone review or face to face consultation with the asthma nurse. MAIN OUTCOME MEASURES: Primary outcome measures were the proportion of participants who were reviewed within three months of randomisation and disease specific quality of life, as measured by the Juniper mini asthma quality of life questionnaire. Secondary outcome measures included the validated "short Q" asthma morbidity score, nursing care satisfaction questionnaire score, and length of consultation. RESULTS: Of 137 people randomised to telephone consultation, 101 (74%) were reviewed, compared with 68 reviewed (48%) of the 141 people in the surgery group, a difference of 26% (95% confidence interval 14% to 37%; P<0.001; number needed to treat 3.8). Three months after randomisation the two groups did not differ in the Juniper score (risk difference -0.07 (95% confidence interval -0.40 to 0.27) or in satisfaction with the consultation (risk difference -0.07 (-0.27 to 0.13)). Telephone consultations were on average 10 minutes shorter than reviews held in the surgery (mean difference 10.7 minutes (12.6 to 8.8; P<0.001)). CONCLUSIONS: Compared with face to face consultations in the surgery, telephone consultations enable more people with asthma to be reviewed, without clinical disadvantage or loss of satisfaction. A shorter duration means that telephone consultations are likely to be an efficient option in primary care for routine review of asthma.

Asthma↗

PubMed2000

Family support for stroke: a randomised controlled trial.

BACKGROUND: Attention is currently focused on family care of stroke survivors, but the effectiveness of support services is unclear. We did a single-blind, randomised, controlled trial to assess the impact of family support on stroke patients and their carers. METHODS: Patients with acute stroke admitted to hospitals in Oxford, UK, were assigned family support or normal care within 6 weeks of stroke. After 6 months, we assessed, for carers, knowledge about stroke, Frenchay activities index, general health questionnaire-28 scores, caregiver strain index, Dartmouth co-op charts, short form 36 (SF-36), and satisfaction scores, and, for patients, knowledge about stroke and use of services, Barthel index, Rivermead mobility index, Frenchay activities index, London handicap scale, hospital anxiety and depression scales, Dartmouth co-op charts, and satisfaction. FINDINGS: 323 patients and 267 carers were followed up. Carers in the intervention group had significantly better Frenchay activities indices (p=0.03), SF-36 scores (energy p=0.02, mental health p=0.004, pain p=0.03, physical function p=0.025, and general health perception p=0.02), quality of life on the Dartmouth co-op chart (p=0.01), and satisfaction with understanding of stroke (82 vs 71%, p=0.04) than those in the control group. Patients' knowledge about stroke, disability, handicap, quality of life, and satisfaction with services and understanding of stroke did not differ between groups. Fewer patients in the intervention group than in the control group saw a physiotherapist after discharge (44 vs 56%, p=0.04), but use of other services was similar. INTERPRETATION: Family support significantly increased social activities and improved quality of life for carers, with no significant effects on patients.

Aged↗