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Results for “Randomised Controlled Trial”

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PubMed2005

Effect of psychiatry liaison with general practitioners on depression severity in recently hospitalised cardiac patients: a randomised controlled trial.

OBJECTIVE: To evaluate the effect on depressive symptoms in cardiac patients of patient-specific advice to general practitioners regarding management of comorbid depression. DESIGN AND SETTING: A randomised controlled trial in four general hospitals in Adelaide, South Australia. PARTICIPANTS: Patients (n = 669) admitted to cardiology units for a range of cardiovascular conditions who were screened and assessed as being depressed according to the Center for Epidemiological Studies Depression Scale (CES-D). INTERVENTION: Inpatient psychiatric review, followed by telephone case conferencing between specialist hospital staff and GPs to provide patient-specific information about the patient's depression and its management, educational material, and ongoing clinical support. MAIN OUTCOME MEASURES: Level of depression severity at 12 months post-hospitalisation. RESULTS: On the basis of intention to treat, intervention patients had lower rates of moderate to severe depression (CES-D > or = 27) after 12 months (25% v 35%, relative risk, 0.72; 95% CI, 0.54-0.96, number needed to treat for benefit, 11). The intervention was most effective in preventing progression from mild depression to moderate to severe depression. The multidisciplinary telephone case conferencing was difficult to implement and, in a post hoc analysis, brief phone advice from a psychiatrist was found to be effective. CONCLUSIONS: Screening hospitalised cardiac patients for depression and providing targeted advice to their GPs reduces depression severity 12 months after hospitalisation.

Adolescent↗

PubMed2002

Randomised controlled trials in primary care: scope and application.

There is now widespread acknowledgement of the absence of a sound evidence base underpinning many of the decisions made in primary care. Randomised controlled trials represent the methodology of choicefor determining efficacy and effectiveness of interventions, yet researchers working in primary care have been reluctant to use intervention studies, favouring observational study designs. Unfamiliarity with the different trial designs now available, and the relative advantages and disadvantages conferred by each, may be one factor contributing to this paradox. In this paper, we consider the principal trial designs available to primary care researchers, discussing the contexts in which a particular design may prove most useful. This information will, we hope, also prove useful to primary care clinicians attempting to interpret trial findings.

Bias↗

PubMed2001

Does treatment of non-malignant hypertension reduce the incidence of renal dysfunction? A meta-analysis of 10 randomised, controlled trials.

OBJECTIVE: It remains controversial whether non-malignant 'benign' hypertension causes renal dysfunction. The effect of lowering blood pressure on the incidence of renal dysfunction among patients with non-malignant hypertension is not clear. This meta-analysis was conducted to determine whether antihypertensive drug therapy reduces the incidence of renal dysfunction in patients with non-malignant hypertension. METHODS: Randomised, controlled trials of antihypertensive drug therapy of more than 1 year duration that reported renal dysfunction as an outcome were identified through MEDLINE search and literature review. A random effects model was used to obtain summary estimates. RESULTS: Ten trials were identified, involving 26, 521 individuals and 114 000 person-years. All excluded subjects with advanced baseline renal disease. Definition of renal dysfunction outcome varied among trials but within each trial was applied similarly to both treatment and control groups. Drug treatment consisted mostly of diuretics and adrenergic blockers. Overall, treated patients had lower blood pressure and fewer cardiovascular events. There were a total of 317 cases of renal dysfunction. Patients randomised to antihypertensive therapy (or more intensive therapy) did not have a significant reduction in their risk of developing renal dysfunction (relative risk = 0.97; 95% confidence interval (CI) 0.78-1.21; P = 0.77). CONCLUSIONS: Among patients with non-malignant hypertension enrolled in randomised trials, treated patients did not have a lower risk of renal dysfunction. The 95% CI suggests that a 25% or more true protective effect of antihypertensive drugs is unlikely.

Adult↗

PubMed2002

Outpatient video EEG recording in the diagnosis of non-epileptic seizures: a randomised controlled trial of simple suggestion techniques.

OBJECTIVE: To assess the yield of recorded habitual non-epileptic seizures during outpatient video EEG, using simple suggestion techniques based on hyperventilation and photic stimulation. DESIGN: Randomised controlled trial of "suggestion" v "no suggestion" during outpatient video EEG recording. SETTING: Regional epilepsy service (tertiary care; single centre). PARTICIPANTS: 30 patients (22 female, 8 male), aged over 16 years, with a probable clinical diagnosis of non-epileptic seizures; 15 were randomised to each group. MAIN OUTCOME MEASURES: Yield of habitual non-epileptic seizures recorded, and requirement for additional inpatient video EEG. RESULTS: 10/15 patients had habitual non-epileptic seizures with suggestion; 5/15 had non-epileptic seizures with no suggestion (p = 0.058; NS); 8/9 patients with a history of previous events in medical settings had non-epileptic seizures recorded during study. Logistic regression analysis with an interaction clause showed a significant effect of suggestion in patients with a history of previous events in medical settings (p = 0.003). An additional inpatient video-EEG was avoided in 14 of the 30 patients (47%). CONCLUSIONS: Habitual non-epileptic seizures can be recorded reliably during short outpatient video EEG in selected patients. Simple (non-invasive) suggestion techniques increase the yield at least in the subgroup with a history of previous events in medical settings. Inpatient video EEG can be avoided in some patients.

Adult↗

PubMed2000

Randomised controlled trial comparing cost effectiveness of general practitioners and nurse practitioners in primary care.

OBJECTIVE: To compare the cost effectiveness of general practitioners and nurse practitioners as first point of contact in primary care. DESIGN: Multicentre randomised controlled trial of patients requesting an appointment the same day. SETTING: 20 general practices in England and Wales. PARTICIPANTS: 1716 patients were eligible for randomisation, of whom 1316 agreed to randomisation and 1303 subsequently attended the clinic. Data were available for analysis on 1292 patients (651 general practitioner consultations and 641 nurse practitioner consultations). MAIN OUTCOME MEASURES: Consultation process (length of consultation, examinations, prescriptions, referrals), patient satisfaction, health status, return clinic visits over two weeks, and costs. RESULTS: Nurse practitioner consultations were significantly longer than those of the general practitioners (11.57 v 7.28 min; adjusted difference 4. 20, 95% confidence interval 2.98 to 5.41), and nurses carried out more tests (8.7% v 5.6% of patients; odds ratio 1.66, 95% confidence interval 1.04 to 2.66) and asked patients to return more often (37. 2% v 24.8%; 1.93, 1.36 to 2.73). There was no significant difference in patterns of prescribing or health status outcome for the two groups. Patients were more satisfied with nurse practitioner consultations (mean score 4.40 v 4.24 for general practitioners; adjusted difference 0.18, 0.092 to 0.257). This difference remained after consultation length was controlled for. There was no significant difference in health service costs (nurse practitioner 18.ll pound sterling v general practitioner 20.70 pound sterling adjusted difference 2.33 pound sterling - 1.62 pound sterling to 6.28 pound sterling). CONCLUSIONS: The clinical care an health service costs of nurse practitioners and general practitioners were similar. If nurse practitioners were able to maintain the benefits while reducing their return consultation rate or shortening consultation times, they could be more cost effective than general practitioners.

Adolescent↗

PubMed2005

St John's wort for depression: meta-analysis of randomised controlled trials.

BACKGROUND: Extracts of Hypericum perforatum (St John's wort) are widely used to treat depression. Evidence for its efficacy has been criticised on methodological grounds. AIMS: To update evidence from randomised trials regarding the effectiveness of Hypericum extracts. METHODS: We performed a systematic review and meta-analysis of 37 double-blind randomised controlled trials that compared clinical effects of Hypericum monopreparation with either placebo or a standard antidepressant in adults with depressive disorders. RESULTS: Larger placebo-controlled trials restricted to patients with major depression showed only minor effects over placebo, while older and smaller trials not restricted to patients with major depression showed marked effects. Compared with standard antidepressants Hypericum extracts had similar effects. CONCLUSIONS: Current evidence regarding Hypericum extracts is inconsistent and confusing. In patients who meet criteria for major depression, several recent placebo-controlled trials suggest that Hypericum has minimal beneficial effects while other trials suggest that Hypericum and standard antidepressants have similar beneficial effects.

Antidepressive Agents↗

PubMed2004

A prospective randomised controlled trial of nutritional supplementation in malnourished elderly in the community: clinical and health economic outcomes.

BACKGROUND & AIMS: Malnutrition is common in sick elderly people on admission to hospital and in the community. We conducted a randomised controlled trial to determine if nutritional supplementation after discharge from hospital improved nutritional status and functional outcomes, or reduced health-care costs. METHODS: Elderly malnourished subjects were randomised to 8 weeks of supplementation or no supplementation post discharge, and followed up for 24 weeks. Weight, body mass index, anthropometrics, handgrip strength, quality of life and requirements for health-care professionals' services and social services were measured throughout the study. RESULTS: Nutritional status improved significantly from baseline to week 24 in the intervention group (P<0.05), but not in the control group. There was no significant difference in nutritional status between groups at week 24. Handgrip strength improved significantly in the intervention group during supplementation, and was significantly different from that of the control group at week 8, but decreased thereafter. There was no significant difference in quality of life or health economic outcomes between groups at week 24. CONCLUSIONS: In already malnourished elderly subjects, it may be too late to expect to improve function or quality of life or to reduce health-care costs simply by providing nutritional supplements after hospitalisation. Prevention is key. All elderly patients should be nutritionally assessed as part of their routine care, and appropriate intervention initiated early.

Aged↗

PubMed2004

Implementation of RCGP guidelines for acute low back pain: a cluster randomised controlled trial.

BACKGROUND: The Royal College of General Practitioners (RCGP) has produced guidelines for the management of acute low back pain in primary care. AIM: To investigate the impact on patient management of an educational strategy to promote these guidelines among general practitioners (GPs). DESIGN OF STUDY: Group randomised controlled trial, using the health centre as the unit of randomisation. SETTING: Primary care teams in north-west England. METHOD: Twenty-four health centres were randomly allocated to an intervention or control arm. Practices in the intervention arm were offered outreach visits to promote national guidelines on acute low back pain, as well as access to fast-track physiotherapy and to a triage service for patients with persistent symptoms. RESULTS: Twenty-four centres were randomised. Two thousand, one hundred and eighty-seven eligible patients presented with acute low back pain during the study period: 1049 in the intervention group and 1138 in the control group. There were no significant differences between study groups in the proportion of patients who were referred for X-ray, issued with a sickness certificate, prescribed opioids or muscle relaxants, or who were referred to secondary care, but significantly more patients in the intervention group were referred to physiotherapy or the back pain unit (difference in proportion = 12.2%, 95% confidence interval [CI] = 2.8% to 21.6%). CONCLUSION: The management of patients presenting with low back pain to primary care was mostly unchanged by an outreach educational strategy to promote greater adherence to RCGP guidelines among GPs. An increase in referral to physiotherapy or educational programmes followed the provision of a triage service.

Adolescent↗

PubMed2003

Redesigning postnatal care: a randomised controlled trial of protocol-based midwifery-led care focused on individual women's physical and psychological health needs.

OBJECTIVES: To develop, implement and test the cost-effectiveness of redesigned postnatal care compared with current care on women's physical and psychological health. DESIGN: A cluster randomised controlled trial, with general practice as the unit of randomisation. Recruited women were followed up by postal questionnaire at 4 and 12 months postpartum and further data collected from midwife and general practice sources. SETTING: Thirty-six randomly selected general practice clusters in the West Midlands Health Region, UK. PARTICIPANTS: All women expected to be resident within recruited practices for postnatal care were eligible for inclusion. Attached midwives recruited 1087 women in the intervention and 977 in the control practice clusters. INTERVENTIONS: The systematic identification and management of women's health problems, led by midwives with general practitioner contact only when required. Symptom checklists and the Edinburgh Postnatal Depression Scale (EPDS) were used at various times to maximise the identification of problems, and individual care and visit plans based on needs. Evidence-based guidelines were used to manage needs. Care was delivered over a longer period. MAIN OUTCOME MEASURES: Women's health at 4 and 12 months, assessed by the Physical and Mental Component Scores (PCS and MCS) of the Short-Form 36 (SF-36) and the EPDS. Women's views about care, reported morbidity at 12 months, health service usage during the year, 'good practice' indicators and health professionals' views about care were secondary outcomes. RESULTS: At 4 and 12 months postpartum the mean MCS and EPDS scores were significantly better in the intervention group and the proportion of women with an EPDS score of 13+ (indicative of probable depression) was significantly lower relative to controls. The physical health score (PCS) did not differ. Health service usage was significantly less in the intervention group as well as reported psychological morbidity at 12 months. Women's views about care were either more positive or did not differ. Intervention midwives were more satisfied with redesigned care than control midwives were with standard care. Intervention care was cost-effective since outcomes were better and costs did not differ substantially. CONCLUSIONS: The redesigned community postnatal care led by midwives and delivered over a longer period, resulted in an improvement in women's mental health at 4 months postpartum, which persisted at 12 months and at equivalent overall cost. It is suggested that further research should focus on: the identification of postnatal depression through screening; whether fewer adverse longer term effects might be demonstrated among the children of the women who had the intervention care relative to the controls; testing interventions to reduce physical morbidity, including studies to validate measures of physical health in postpartum women. Further research is also required to investigate appropriate postnatal care for ethnic minority groups.

Adolescent↗

PubMed2000

Introduction of the Misgav Ladach caesarean section at an African tertiary centre: a randomised controlled trial.

OBJECTIVE: To determine whether the Misgav Ladach caesarean section technique can offer benefits compared with conventional caesarean section technique in the prevailing conditions of a busy African tertiary centre. DESIGN: A randomised controlled trial. SETTING: A tertiary African obstetric unit with 18,000 deliveries annually. PARTICIPANTS: Three hundred and thirty-nine women undergoing caesarean section. METHODS: Eight residents and registrars were instructed in the Misgav Ladach technique for caesarean section during one week, after which the study commenced. The course participants instructed their colleagues; in total, 16 doctors participated. Women requiring caesarean section were randomised to Misgav Ladach or to the conventional lower midline incision procedure, excluding those with a previous scar. RESULTS: During 11 weeks 339 randomised procedures (328 of which were emergency procedures) were carried out. Mean operating time was 25 x 3 minutes for Misgav Ladach and 32 x 6 minutes for the lower midline incision procedure (95% CI -8 x 3; -6 x 3). Mean blood loss was 354 mL and 447 mL (-133; -53), and the number of sutures 3 x 1 and 6 x 1 (-3 x 1; -2 x 9), respectively. No significant difference was found in Apgar scores. Mobilisation was earlier with the Misgav Ladach procedure. No difference was found in overall post-operative infection rates i.e. wound infection or febrile illness, but the combination of wound infection and fever was more common in the Misgav Ladach group. CONCLUSION: The Misgav Ladach caesarean section confers benefits such as reduced blood loss, conservation of time and suture material, and rapid mobilisation, but more studies are needed to explore modifications aimed at reducing post-operative infections in settings with limited resources.

Adolescent↗

PubMed2000

Evaluation of computer based clinical decision support system and risk chart for management of hypertension in primary care: randomised controlled trial.

OBJECTIVES: To investigate the effect of a computer based clinical decision support system and a risk chart on absolute cardiovascular risk, blood pressure, and prescribing of cardiovascular drugs in hypertensive patients. DESIGN: Cluster randomised controlled trial. SETTING: 27 general practices in Avon. PARTICIPANTS: 614 patients aged between 60 and 79 years with high blood pressure. INTERVENTIONS: Patients were randomised to computer based clinical decision support system plus cardiovascular risk chart; cardiovascular risk chart alone; or usual care. MAIN OUTCOME MEASURES: Percentage of patients in each group with a five year cardiovascular risk >/=10%, systolic blood pressure, diastolic blood pressure, prescribing of cardiovascular drugs. RESULTS: Patients in the computer based clinical decision support system and chart only groups were no more likely to have cardiovascular risk reduced to below 10% than patients receiving usual care. Patients in the computer based clinical decision support group were more likely to have a cardiovascular risk >/=10% than chart only patients, odds ratio 2.3 (95% confidence interval 1.1 to 4.8). The chart only group had significantly lower systolic blood pressure compared with the usual care group (difference in means -4.6 mm Hg (95% confidence interval -8.4 to -0.8)). Reduction of diastolic blood pressure did not differ between the three groups. The chart only group were twice as likely to be prescribed two classes of cardiovascular drugs and over three times as likely to be prescribed three or more classes of drugs compared with the other groups. CONCLUSIONS: The computer based clinical decision support system did not confer any benefit in absolute risk reduction or blood pressure control and requires further development and evaluation before use in clinical care can be recommended. Use of chart guidelines are associated with a potentially important reduction in systolic blood pressure.

Aged↗

PubMed1998

Low sodium diet and pregnancy-induced hypertension: a multi-centre randomised controlled trial.

OBJECTIVE: To examine the effectiveness of the standard policy in the Netherlands to prescribe a sodium restricted diet to prevent or to treat mild pregnancy-induced hypertension. DESIGN: Multi-centre randomised controlled trial between April 1992 and April 1994. SETTING: Seven practices of independent midwives and one university hospital. PARTICIPANTS: The experimental group comprised 184 women given a low sodium diet (< or = 50 mmol sodium/day) and a control group of 177 women given a normal diet. Eligible women for inclusion had had a rise of blood pressure, or excessive weight gain or oedema during the antenatal period. The 361 women in the trial were recruited from 2020 nulliparae, of whom 1512 (75%) gave informed consent at the beginning of their pregnancy to participate in the study. MAIN OUTCOME MEASURES: The difference between highest diastolic blood pressure after randomisation and diastolic blood pressure at the moment of randomisation; referral and admission to hospital for hypertension. RESULTS: There was no difference in increase of diastolic blood pressure after randomisation, the percentage of referral and admission to hospital for hypertension, or in obstetric outcome between the two groups. Urinary sodium excretion after randomisation in the normal diet group was significantly higher than in the low sodium group. CONCLUSION: Prescribing a sodium-restricted diet to prevent or to treat mild pregnancy-induced hypertension is not effective. Therefore there is no need to introduce a salt restricted diet in prenatal care, although increasing evidence shows that a low sodium diet prevents hypertension in non-pregnant individuals.

Adult↗

PubMed2006

Intrarectal administration of lidocaine gel versus plain lubricant gel for pain control during transrectal ultrasound-guided extensive 10-core prostate biopsy in Hong Kong Chinese population: prospective double-blind randomised controlled trial.

OBJECTIVE: To compare the level of pain experienced by patients during transrectal ultrasound-guided prostatic biopsy using intrarectal 2% lidocaine gel versus plain lubricant gel. DESIGN: Prospective double-blind randomised controlled trial. SETTING: Regional hospital, Hong Kong. PATIENTS: From March 2002 to December 2003, patients who underwent ultrasound-guided prostate biopsy at a Geriatric Urology Centre. MAIN OUTCOME MEASURES: Pain and discomfort scores measured by horizontal visual analogue scales. RESULTS: A total of 338 consecutive patients were randomised to lidocaine gel or plain lubricant gel groups. The two groups were statistically similar in demographic and disease characteristics. There were no significant statistical differences in pain or discomfort score in the lidocaine gel and plain lubricant groups--pain score: 1.75 versus 1.79 (P=0.66) on day 0 and 0.21 versus 0.15 (P=0.97) on day 1; discomfort score: 0.79 versus 0.77 (P=0.86) on day 0 and 0.12 versus 0.12 (P=0.76) on day 1. No major complications were recorded in this cohort. CONCLUSIONS: Transrectal ultrasound-guided trucut biopsy of the prostate can be safely performed with no anaesthesia in Chinese patients. Pain and discomfort are minimal. It was found that 2% lidocaine gel has no statistical therapeutic or analgesic benefit over plain lubricant gel.

Administration, Rectal↗

PubMed2004

Routine examination of the newborn: the EMREN study. Evaluation of an extension of the midwife role including a randomised controlled trial of appropriately trained midwives and paediatric senior house officers.

OBJECTIVES: To assess the implications and cost-effectiveness of extending the role of midwives to include the routine (24-hour) examination of the healthy newborn usually carried out by junior doctors. DESIGN: The study included a prospective randomised controlled trial (RCT) with mother and baby dyads randomised to either senior house officer (SHO) or midwife for the routine examination of the newborn. Midwives and SHOs were also videoed while performing the examinations and the videos were rated by an independent consultant and senior midwife. In addition extensive interviews, surveys, consultations and assessments were carried out. SETTING: A District General Hospital (for the RCT), a London Teaching Hospital, general practices and mothers' homes (for interviews); questionnaires were sent to all maternity units in England (for the National Survey). PARTICIPANTS: A total of 826 mother and baby dyads in a District General Hospital in south-east England. Midwives and SHOs, as well as midwifery managers, paediatric consultants; general practitioners (GPs) and representatives of key organisations. INTERVENTIONS: A routine examination of a newborn baby was carried out at about 24 hours from birth and a further examination for half the babies in each group, at 10-days at home by the community midwife. MAIN OUTCOME MEASURES: Referrals assessed as appropriate and as major or minor by three independent consultants. Problems identified during the first year of life assessed as identifiable at 24 hours. Quality assessment by video against an agreed written proforma. Maternal satisfaction. Opinion of professionals and mothers about aspects of the examination. RESULTS: There was no statistical difference between SHO and midwife examinations in appropriate referral rates to hospital or community or in inappropriate referral rates to hospital. Videoed assessments were assessed as carried out more appropriately by the midwives than by the SHOs. Overall maternal satisfaction was high and higher when a midwife rather than an SHO examined. Few new health problems were identified at the 10-day examination. From the National Survey, it was estimated that about 2% of babies in England are examined by a midwife. If midwives were to examine all babies where there were no complications of birth or antenatal history, there would be savings of about 2 pounds per baby born, equivalent to savings of 1.2 pounds million nationally. Were midwives to examine all babies on normal wards savings would increase to about 4.30 pounds per baby born or 2.5 million pounds nationally. Representatives of the professional bodies were of the opinion that having trained midwives carrying out the examination would be valuable. CONCLUSIONS: All component aspects of the study were consistent in showing benefits or at least no significant barriers to suitably qualified, trained midwives carrying out the examinations. Developing the role of the midwife to include examination of the newborn is likely to result in improved quality of examinations and higher satisfaction from mothers. It would slightly reduce overall health service costs, with some increased resources needed by midwifery departments, and some decrease in resource needs of paediatric departments. There is a need for further research into the value of the examination being carried out at home rather than in hospital; the overall unsatisfactory quality of the examination of the hips; and appropriate inclusion criteria for which babies' midwives should examine.

Adult↗

PubMed2004

Needle versus loop diathermy excision of the transformation zone for the treatment of cervical intraepithelial neoplasia: a randomised controlled trial.

OBJECTIVE: To determine whether lower rates or incomplete resection of cervical intraepithelial neoplasia (CIN) may be achieved by needle excision of the transformation zone (NETZ) than with loop excision (LLETZ). DESIGN: A prospective randomised controlled trial. SETTING: A gynaecological oncology centre and a teaching hospital in West London. POPULATION: Four hundred and four women due to receive treatment for suspected CIN. METHODS: Women were randomised to receive either LLETZ or NETZ. MAIN OUTCOME MEASURES: The study was designed to demostrate a difference in the proportion of women with clear histological margins of 82% for LLETZ compared to 94% for NETZ with 90% power at a 5% significance level, allowing for absence of CIN in the treatment specimen in 15%. RESULTS: Four randomised women were excluded from the analysis, as they were ineligible for the study. Three hundred and forty-seven (87%) had CIN in the treatment specimen and could be included in the analysis of excision margins. More women in the NETZ arm had clear histological margins (84.8%vs 75%, (P= 0.03). The median volume of specimens in the NETZ arm was 739 mm(3) larger (P= 0.33) and they were less likely to be removed in multiple pieces (2.5%vs 29.5%, RR 0.09, 95% CI 0.04 to 0.20). Needle excision took longer to perform (median treatment time 210 vs 90 seconds, P<0.0001) and surgeons more often reported the procedure as 'difficult' (9.5%vs 3.0%, RR = 3.17%, 95% CI 1.33 to 7.58). No difference in peri-operative or post-operative complication rates could be demonstrated between the two groups. CONCLUSION: NETZ is more likely to produce a specimen in one piece and with clear margins compared to LLETZ.

Adult↗

PubMed2004

Applying decision analysis to facilitate informed decision making about prenatal diagnosis for Down syndrome: a randomised controlled trial.

OBJECTIVE: To evaluate decision analysis as a technique to facilitate women's decision-making about prenatal diagnosis for Down syndrome using measures of effective decision-making. DESIGN: Randomised controlled trial in a UK hospital's prenatal diagnosis clinic. INTERVENTION: Routine versus routine consultation structured by decision analysis. PARTICIPANTS: 117/132 women receiving a screen-positive maternal serum screening result participated (58 routine, 59 decision analysis). METHODS: Consultations were audio tape-recorded, transcribed and coded; questionnaires were completed after the consultation and one month later after receipt of a diagnostic test and/or the 19-week scan result. MAIN MEASURES: Test decision, subjective expected utilities, knowledge, informed decision-making, risk perception, decisional conflict, anxiety, perceived usefulness and directiveness of consultation information. RESULTS: 48/59 in the decision-aided group and 47/58 in the routine group underwent prenatal diagnosis. Informed decision-making was higher, perceived risk more realistic and decisional conflict over time lower in the decision analysis group. Decision analysis had no impact on knowledge or SEU scores, and was no more or no less directive, useful or anxiety provoking than the routine care. Consultations were six minutes longer. CONCLUSIONS: Decision analysis consultations enable women to make more informed prenatal diagnosis decisions. Professionals will need training to use this technique effectively.

Anxiety↗

PubMed2006

A six-month, supervised, aerobic and resistance exercise program improves self-efficacy in people with human immunodeficiency virus: a randomised controlled trial.

QUESTION: What is the effect of a six-month, supervised, aerobic and resistance exercise program on self-efficacy in men living with human immunodeficiency virus (HIV)? DESIGN: Randomised, controlled trial. PARTICIPANTS: 40 (5 dropouts) men living with HIV, aged 18 years or older. INTERVENTION: The experimental group participated in a twice-weekly supervised aerobic and resistance exercise program for six months and the control group participated in a twice-weekly unsupervised walking program and attended a monthly group forum. OUTCOME MEASURES: The primary outcome measure was self-efficacy using the General Self-Efficacy Scale. Secondary outcome measures were cardiovascular fitness using the Kasch Pulse Recovery test, and health-related quality of life using the Medical Outcomes Study HIV Health Survey. Measures were taken by an assessor blinded to group allocation. RESULTS: By six months, the experimental group had improved their self-efficacy by 6.8 points (95% CI 3.9 to 9.7, p < 0.001) and improved their cardiovascular fitness by reducing their heart rate by 20.2 bpm (95% CI -25.8 to -14.6, p < 0.001) more than the control group. Health-related quality of life improved in only two out of the eleven dimensions: the experimental group improved their overall health by 20.8 points (95% CI 2.0 to 39.7, p = 0.03) and their cognitive function by 14 points (95% CI 0.7 to 27.3, p = 0.04) more than the control group. CONCLUSION: The findings of this study add to the known benefits of exercise for the HIV-infected population.

Adult↗

PubMed2002

Systematic review of randomised controlled trials of psychological therapy for chronic pain in children and adolescents, with a subset meta-analysis of pain relief.

A systematic review and subset meta-analysis of published randomised controlled trials of psychological therapies for children and adolescents with chronic pain is reported. A search of four computerised abstracting services recovered 123 papers from which 28 potential trials were identified. Eighteen met the criteria for inclusion in the review. The majority of these papers reported brief behavioural and cognitive behavioural interventions for children with headache and many were conducted in community (i.e. school) settings. Meta-analysis was applicable for 12 headache trials and one trial of recurrent abdominal pain using the Pain Index. The odds-ratio for a 50% reduction in pain was 9.62 and the number needed to treat was 2.32, indicating that the psychological treatments examined are effective in reducing the pain of headache. The quality of the 18 trials retrieved is narratively reviewed and suggestions for the development of trials in this field are made.

Abdominal Pain↗