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 685 records · Page 38Linked to original sources

PubMed1999

A randomised controlled trial. Shifting boundaries of doctors and physiotherapists in orthopaedic outpatient departments.

OBJECTIVE: To evaluate the effectiveness and cost effectiveness of specially trained physiotherapists in the assessment and management of defined referrals to hospital orthopaedic departments. DESIGN: Randomised controlled trial. SETTING: Orthopaedic outpatient departments in two hospitals. SUBJECTS: 481 patients with musculoskeletal problems referred for specialist orthopaedic opinion. INTERVENTIONS: Initial assessment and management undertaken by post-Fellowship junior orthopaedic surgeons, or by specially trained physiotherapists working in an extended role (orthopaedic physiotherapy specialists). MAIN OUTCOME MEASURES: Patient centred measures of pain, functional disability and perceived handicap. RESULTS: A total of 654 patients were eligible to join the trial, 481 (73.6%) gave their consent to be randomised. The two arms (doctor n = 244, physiotherapist n = 237) were similar at baseline. Baseline and follow up questionnaires were completed by 383 patients (79.6%). The mean time to follow up was 5.6 months after randomisation, with similar distributions of intervals to follow up in both arms. The only outcome for which there was a statistically or clinically important difference between arms was in a measure of patient satisfaction, which favoured the physiotherapist arm. A cost minimisation analysis showed no significant differences in direct costs to the patient or NHS primary care costs. Direct hospital costs were lower (p < 0.00001) in the physiotherapist arm (mean cost per patient = 256 Pounds, n = 232), as they were less likely to order radiographs and to refer patients for orthopaedic surgery than were the junior doctors (mean cost per patient in arm = 498 Pounds, n = 238). CONCLUSIONS: On the basis of the patient centred outcomes measured in this randomised trial, orthopaedic physiotherapy specialists are as effective as post-Fellowship junior staff and clinical assistant orthopaedic surgeons in the initial assessment and management of new referrals to outpatient orthopaedic departments, and generate lower initial direct hospital costs.

Adolescent↗

PubMed2005

Comparison of Bobath based and movement science based treatment for stroke: a randomised controlled trial.

OBJECTIVES: Bobath based (BB) and movement science based (MSB) physiotherapy interventions are widely used for patients after stroke. There is little evidence to suggest which is most effective. This single-blind randomised controlled trial evaluated the effect of these treatments on movement abilities and functional independence. METHODS: A total of 120 patients admitted to a stroke rehabilitation ward were randomised into two treatment groups to receive either BB or MSB treatment. Primary outcome measures were the Rivermead Motor Assessment and the Motor Assessment Scale. Secondary measures assessed functional independence, walking speed, arm function, muscle tone, and sensation. Measures were performed by a blinded assessor at baseline, and then at 1, 3, and 6 months after baseline. Analysis of serial measurements was performed to compare outcomes between the groups by calculating the area under the curve (AUC) and inserting AUC values into Mann-Whitney U tests. RESULTS: Comparison between groups showed no significant difference for any outcome measures. Significance values for the Rivermead Motor Assessment ranged from p = 0.23 to p = 0.97 and for the Motor Assessment Scale from p = 0.29 to p = 0.87. CONCLUSIONS: There were no significant differences in movement abilities or functional independence between patients receiving a BB or an MSB intervention. Therefore the study did not show that one approach was more effective than the other in the treatment of stroke patients.

Aged↗

PubMed2004

Are occupational therapists more effective than social workers when assessing frail older people? Results of CAMELOT, a randomised controlled trial.

OBJECTIVES: To compare the effectiveness of occupational therapist-led assessments of older people on dependency and service costs with that of social worker-led assessments. DESIGN: Pragmatic community-based randomised controlled trial over 2 years 4 months. SETTING: Cambridgeshire, UK. PARTICIPANTS: 321 older people aged 65 and over living in their own homes and 113 carers. INTERVENTION: participants were randomised to two groups, to receive either occupational therapist-led or social worker-led assessment. OUTCOME MEASURES: Primary outcome was dependency (Community Dependency Index). Secondary outcomes included quality of life scores (EQ-5D) and psychological outlook (Perceived Stress Scale (PSS)). Outcome measures for carers included Carer Assessment of Difficulty Index (CADI), PSS and EQ-5D, collected at baseline, 4 and 8 months. Resource use data were collected from professional practice records, participants and carers at final follow-up. RESULTS: 264 (82%) of the randomised participants completed the study. No between-group statistically significant differences were found, except that carers in the occupational therapist arm had significantly better EQ-5D scores at the 8 month follow-up (thermometer P = 0.03) and in the social worker arm better CADI scores on stress (P = 0.047) and amount of caring (P = 0.049). CONCLUSIONS: There was no clear difference in patient-centred effectiveness measures between occupational therapists and social workers in assessing frail older people and their carers in the community. More extensive use of primary care health services by occupational therapists may have contributed to the differences in EQ-5D scores for carers. Delays in making occupational therapy assessments and in completing recommended housing adaptations may have contributed to these negative findings.

Aged↗

PubMed2003

Diagnosis of somatisation: effect of an educational intervention in a cluster randomised controlled trial.

BACKGROUND: Somatisation is highly prevalent in primary care (present in 25% of visiting patients) but often goes unrecognised. Non-recognition may lead to ineffective treatment, risk of iatrogenic harm, and excessive use of healthcare services. AIM: To examine the effect of training on diagnosis of somatisation in routine clinical practice by general practitioners (GPs). DESIGN OF STUDY: Cluster randomised controlled trial, with practices as the randomisation unit. SETTING: Twenty-seven general practices (with a total of 43 GPs) in Vejle County, Denmark. METHOD: Intervention consisted of a multifaceted training programme (the TERM [The Extended Reattribution and Management] model). Patients were enrolled consecutively over a period of 13 working days. Psychiatric morbidity was assessed by means of a screening questionnaire. GPs categorised their diagnoses in another questionnaire. The primary outcome was GP diagnosis of somatisation and agreement with the screening questionnaire. RESULTS: GPs diagnosed somatisation less frequently than had previously been observed, but there was substantial variation between GPs. The difference between groups in the number of diagnoses of somatisation failed to reach the 5% significance (P = 0.094). However, the rate of diagnoses of medically unexplained physical symptoms was twice as high in the intervention group as in the control group (7.7% and 3.9%, respectively, P = 0.007). Examination of the agreement between GPs' diagnoses and the screening questionnaire revealed no significant difference between groups. CONCLUSION: Brief training increased GPs' awareness of medically unexplained physical symptoms. Diagnostic accuracy according to a screening questionnaire remained unaffected but was difficult to evaluate, as there is no agreement on a gold standard for somatisation in general practice.

Adult↗

PubMed1999

Transmyocardial laser revascularisation in patients with refractory angina: a randomised controlled trial.

BACKGROUND: Transmyocardial laser revascularisation (TMLR) is used to treat patients with refractory angina due to severe coronary artery disease, not suitable for conventional revascularisation. We aimed in a randomised controlled trial to assess the effectiveness of TMLR compared with medical management. METHODS: 188 patients with refractory angina were randomly assigned TMLR plus normal medication or medical management alone. At 3 months, 6 months, and 12 months after surgery (TMLR) or initial assessment (medical management) we assessed exercise capacity with the treadmill test and the 12 min walk. FINDINGS: Mean treadmill exercise time, adjusted for baseline values, was 40 s (95% CI -15 to 94) longer in the TMLR group than in the medical-management group at 12 months (p=0.152). Mean 12 min walk distance was 33 m (-7 to 74) further in TMLR patients than medical-management patients (p=0.108) at 12 months. The differences were not significant or clinically important. Perioperative mortality was 5%. Survival at 12 months was 89% (83-96) in the TMLR group and 96% (92-100) in the medical-management group (p=0.14). Canadian Cardiovascular Society score for angina had decreased by at least two classes in 25% of TMLR and 4% of medical-management patients at 12 months (p<0.001). INTERPRETATION: Our findings show that the adoption of TMLR cannot be advocated. Further research may be appropriate to assess any potential benefit for sicker patients.

Angina Pectoris↗

PubMed2006

[On the efficacy of acute psychiatric day-care treatment in a one-year-follow-up. A comparison to inpatient treatment within a randomised controlled trial].

OBJECTIVE: To compare the effectiveness of acute psychiatric day-hospital treatment and inpatient treatment with respect to a one-year follow-up. METHOD: Within a randomised controlled trial, patients and relatives were assessed at different levels of outcome three months and 12 months after patients' discharge using the Brief Psychiatric Rating Scale (24-Item-Version), the Manchester Assessment of Quality of Life (MANSA), the Groningen Social Disabilities Schedule (GSDS), the Berlin Inventory for the Assessment of Needs (BeBI), and the Involvement Evaluation Questionnaire (IEQ). Using estimation and test of contrasts in linear models of analysis of variance with structured covariance matrix, analyses conducted included data of all n = 191 patients having been included into the German centre of the study. RESULTS: With respect to all measures, day-hospital treatment proved to be at least as effective as inpatient care. CONCLUSION: The study supports earlier findings that showed no differences in long-term effectiveness of acute psychiatric day-hospital treatment as compared to inpatient treatment.

Acute Disease↗

PubMed2002

Randomised controlled trial of glove perforation in single and double-gloving methods in gynaecologic surgery.

OBJECTIVE: To assess the value of double-gloving in gynaecological surgery. DESIGN: A prospective randomised controlled trial of glove perforation in single- and double-gloving methods. SETTING: Rajavithi Hospital between 1 September 1999 to 31 August 2000. SAMPLE: Eighty-eight (88) and 82 primary surgeons were selected at random to make up single- and double-gloving groups, respectively, while performing total abdominal hysterectomy (TAH) with or without bilateral salpingo-oophorectomy (BSO). METHODS: The gloves were tested by immersion in water. RESULTS: The glove perforation rate was 6.09% and 22.73% in double-inner and single gloves, respectively, with this difference being statistically different (p < 0.05). There was no significant difference between the glove perforation rates in single gloves (22.73%) and in double-outer gloves (19.51%). There was matched perforation of the same finger of both outer and inner gloves in 1.22% of total double-inner gloves. CONCLUSIONS: The double-gloving methods significantly reduced the risk of surgeons' hands contacting blood, when compared with the single-gloving method, in TAH with/or without BSO.

Equipment Failure↗

PubMed2005

Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial.

OBJECTIVE: To assess the effectiveness of 600 microg oral misoprostol on postpartum haemorrhage (PPH) and postpartum anaemia in a low income country home birth situation. DESIGN: Double blind randomised controlled trial. SETTING: Twenty-six villages in rural Gambia with 52 traditional birth attendants (TBAs). SAMPLE: One thousand, two hundred and twenty-nine women delivering at home under the guidance of a trained TBA. METHODS: Active management of the third stage of labour using three 200-microg misoprostol tablets and placebo or four 0.5-mg ergometrine tablets (standard treatment) and placebo. Tablets were taken orally immediately after delivery. MAIN OUTCOME MEASURES: Measured blood loss, postpartum haemoglobin (Hb), difference between Hb at the last antenatal care visit and three to five days postpartum. RESULTS: The misoprostol group experienced lower incidence of measured blood loss > or =500 mL and postpartum Hb <8 g/dL, but the differences were not statistically significant. The reduction in postpartum (compared with pre-delivery) Hb > or = 2 g/dL was 16.4% with misoprostol and 21.2% with ergometrine [relative risk 0.77; 95% confidence interval (CI) 0.60-0.98; P= 0.02]. Shivering was significantly more common with misoprostol, while vomiting was more common with ergometrine. Only transient side effects were observed. CONCLUSIONS: Six hundred micrograms of oral misoprostol is a promising drug to prevent life-threatening PPH in this setting.

Abortifacient Agents, Nonsteroidal↗

PubMed2005

Can exercise improve self esteem in children and young people? A systematic review of randomised controlled trials.

A systematic review to determine if exercise alone or as part of a comprehensive intervention can improve self esteem in children and young people is described. Twenty three randomised controlled trials were analysed. A synthesis of several small, low quality trials indicates that exercise may have short term beneficial effects on self esteem in children and adolescents. However, high quality research on defined populations with adequate follow up is needed.

Adolescent↗

PubMed1995

Health checks and coronary risk: further evidence from a randomised controlled trial.

OBJECTIVE: To determine the effectiveness of a health check and assess any particular benefits resulting from feedback of plasma cholesterol concentration or coronary risk score, or both. DESIGN: Randomised controlled trial in two Glasgow work sites. SUBJECTS: 1,632 employees (89% male) aged 20 to 65 years. INTERVENTIONS: At the larger work site, (a) health education; (b) health education and feedback on cholesterol concentration; (c) health education and feedback on risk score; (d) health education with feedback on cholesterol concentration and risk score (full health check); (e) no health intervention (internal control). At the other work site there was no health intervention (external control). MAIN OUTCOME MEASURES: Changes in Dundee risk score, plasma cholesterol concentration, diastolic blood pressure, body mass index and self-reported behaviours (smoking, exercise, alcohol intake, and diet) in comparison with internal and external control groups. RESULTS: Comparisons between the full health check and the internal control groups showed a small difference (0.13 mmol/l) in the change in mean cholesterol concentration (95% confidence interval 0.02 to 0.22, P = 0.02) but no significant differences for changes in Dundee risk score (P = 0.21), diastolic blood pressure (P = 0.71), body mass index (P = 0.16), smoking (P = 1.00) or exercise (P = 0.41). Significant differences between the two groups were detected for changes in self-reported consumption of alcohol (41% in group with full health check v 17% in internal control group, P = 0.001) fruit and vegetables (24% v 12%, P < 0.001), and fat (30% v 9%, P < 0.001). Comparison of all groups showed no advantage from feedback of cholesterol concentration or risk score, or both. CONCLUSIONS: The health check only had a small effect on reversible coronary risk. It was effective in influencing self reported alcohol consumption and diet. Feedback on cholesterol concentration and on risk score did not provide additional motivation for a change in behaviour.

Adult↗

PubMed1999

Effect of postal prompts to patients and general practitioners on the quality of primary care after a coronary event (POST): randomised controlled trial.

OBJECTIVES: To determine whether postal prompts to patients who have survived an acute coronary event and to their general practitioners improve secondary prevention of coronary heart disease. DESIGN: Randomised controlled trial. SETTING: 52 general practices in east London, 44 of which had received facilitation of local guidelines for coronary heart disease. PARTICIPANTS: 328 patients admitted to hospital for myocardial infarction or unstable angina. INTERVENTIONS: Postal prompts sent 2 weeks and 3 months after discharge from hospital. The prompts contained recommendations for lowering the risk of another coronary event, including changes to lifestyle, drug treatment, and making an appointment to discuss these issues with the general practitioner or practice nurse. MAIN OUTCOME MEASURES: Proportion of patients in whom serum cholesterol concentrations were measured; proportion of patients prescribed beta blockers (6 months after discharge); and proportion of patients prescribed cholesterol lowering drugs (1 year after discharge). RESULTS: Prescribing of beta bockers (odds ratio 1.7, 95% confidence interval 0.8 to 3.0, P>0.05) and cholesterol lowering drugs (1.7, 0. 8 to 3.4, P>0.05) did not differ between intervention and control groups. A higher proportion of patients in the intervention group (64%) than in the control group (38%) had their serum cholesterol concentrations measured (2.9, 1.5 to 5.5, P<0.001). Secondary outcomes were significantly improved for consultations for coronary heart disease, the recording of risk factors, and advice given. There were no significant differences in patients' self reported changes to lifestyle or to the belief that it is possible to modify the risk of another coronary event. CONCLUSIONS: Postal prompts to patients who had had acute coronary events and to their general practitioners in a locality where guidelines for coronary heart disease had been disseminated did not improve prescribing of effective drugs for secondary prevention or self reported changes to lifestyle. The prompts did increase consultation rates related to coronary heart disease and the recording of risk factors in the practices. Effective secondary prevention of coronary heart disease requires more than postal prompts and the dissemination of guidelines.

Adrenergic beta-Antagonists↗

PubMed1999

Improving the health behaviours of elderly people: randomised controlled trial of a general practice education programme.

OBJECTIVES: To establish the effect of an educational intervention for general practitioners on the health behaviours and wellbeing of elderly patients. DESIGN: Randomised controlled trial with 1 year follow up. SETTING: Metropolitan general practices in Melbourne, Australia. SUBJECTS: 42 general practitioners and 267 of their patients aged over 65 years. INTERVENTION: Educational and clinical practice audit programme for general practitioners on health promotion for elderly people. MAIN OUTCOME MEASURES: Patients' physical activity, functional status, self rated health, immunisation status, social contacts, psychological wellbeing, drug usage, and rate of influenza vaccination. Primary efficacy variables were changes in outcome measures over 1 year period. RESULTS: Patients in the intervention group had increased (a) walking by an average of 88 minutes per fortnight, (b) frequency of pleasurable activities, and (c) self rated health compared with the control group. No change was seen in drug usage, rate of influenza vaccination, functional status, or psychological wellbeing as a result of the intervention. Extrapolations of the known effect of these changes in behaviour suggest mortality could be reduced by 22% if activity was sustained for 5 years. CONCLUSIONS: Education of the general practitioners had a positive effect on health outcomes of their elderly patients. General practitioners may have considerable public health impact in promotion of health for elderly patients.

Aged↗

PubMed2001

Reducing violence in severe mental illness: randomised controlled trial of intensive case management compared with standard care.

OBJECTIVES: To establish whether intensive case management reduces violence in patients with psychosis in comparison with standard case management. DESIGN: Randomised controlled trial with two year follow up. SETTING: Four inner city community mental health services. PARTICIPANTS: 708 patients with established psychotic illness allocated at random to intervention (353) or control (355) group. INTERVENTION: Intensive case management (caseload 10-15 per case manager) for two years compared with standard case management (30-35 per case manager). MAIN OUTCOME MEASURE: Physical assault over two years measured by interviews with patients and case managers and examination of case notes. RESULTS: No significant reduction in violence was found in the intensive case management group compared with the control group (22.7% v 21.9%, P=0.86). CONCLUSIONS: Intensive case management does not reduce the prevalence of violence in psychotic patients in comparison with standard care.

Adult↗

PubMed2002

Mechanical methods of reducing blood transfusion in cardiac surgery: randomised controlled trial.

OBJECTIVE: To assess the effectiveness of two mechanical methods of blood conservation in reducing the need for allogeneic red blood cells or coagulation products during cardiac surgery. DESIGN: Randomised controlled trial. SETTING: Regional cardiac centre in a teaching hospital in Southampton. PARTICIPANTS: 263 adults aged 18-80 years undergoing elective coronary artery bypass surgery entered the study, of whom 252 completed the trial. All patients received routine perioperative care. Patients were allocated to one of three treatment groups: intraoperative cell salvage, intraoperative cell salvage with acute perioperative normovolaemic haemodilution, or no mechanical blood conservation. There were 84 patients in each group. MAIN OUTCOME MEASURES: Numbers of patients who received allogeneic blood or coagulation products, and the mean number of units of blood transfused per patient. RESULTS: Of the patients in the intraoperative cell salvage group, 26 were given a transfusion of allogeneic blood, compared with 43 in the control group (odds ratio 0.43 (95% confidence interval 0.23 to 0.80)). The mean number of units of allogeneic blood transfused per patient in the intraoperative cell salvage group was 0.68 units (SD=1.55), compared with 1.07 (1.56) units in the control group. 32 of the patients in the intraoperative cell salvage group were given any blood product, compared with 47 in the control group (odds ratio 0.47 (0.25 to 0.89); P=0.019). Combining acute perioperative normovolaemic haemodilution with intraoperative cell salvage conferred no additional benefits. CONCLUSIONS: An intraoperative cell salvage device should be used in elective coronary artery bypass grafting. Pharmacological strategies may achieve further reductions in blood transfusions. Yet further reductions in blood transfusions could be achieved if the lower safe limit of haemoglobin concentration in patients undergoing cardiac surgery were known.

Adolescent↗

PubMed2003

Clinical efficacy of three common treatments in acute otitis externa in primary care: randomised controlled trial.

OBJECTIVE: To compare the clinical efficacy of ear drops containing acetic acid, corticosteroid and acetic acid, and steroid and antibiotic in acute otitis externa in primary care. DESIGN: Randomised controlled trial. SETTING: 79 general practices, Netherlands. PARTICIPANTS: 213 adults with acute otitis externa. MAIN OUTCOME MEASURES PRIMARY OUTCOME: duration of symptoms (days) according to patient diaries. Secondary outcome: cure rate according to general practitioner completed questionnaires and recurrence of symptoms between days 21 and 42. RESULTS: Symptoms lasted for a median of 8.0 days (95% confidence interval 7.0 to 9.0) in the acetic acid group, 7.0 days (5.8 to 8.3) in the steroid and acetic acid group, and 6.0 days (5.1 to 6.9) in the steroid and antibiotic group. The overall cure rates at seven, 14, and 21 days were 38%, 68%, and 75%, respectively. Compared with the acetic acid group, significantly more patients were cured in the steroid and acetic acid group and steroid and antibiotic group at day 14 (odds ratio 2.4, 1.1 to 5.3, and 3.5, 1.6 to 7.7, respectively) and day 21 (5.3, 2.0 to 13.7, and 3.9, 1.7 to 9.1, respectively). Recurrence of symptoms between days 21 and 42 occurred in 29% (50/172) of patients and was seen significantly less in the steroid and acetic acid group (0.3, 0.1 to 0.7) and steroid and antibiotic group (0.4, 0.2 to 1.0) than in the acetic acid group. CONCLUSIONS: Ear drops containing corticosteroids are more effective than acetic acid ear drops in the treatment of acute otitis externa in primary care. Steroid and acetic acid or steroid and antibiotic ear drops are equally effective.

Acetic Acid↗

PubMed2004

Specialist nurse intervention to reduce unscheduled asthma care in a deprived multiethnic area: the east London randomised controlled trial for high risk asthma (ELECTRA).

OBJECTIVE: To determine whether asthma specialist nurses, using a liaison model of care, reduce unscheduled care in a deprived multiethnic area. DESIGN: Cluster randomised controlled trial. SETTING: 44 general practices in two boroughs in east London. PARTICIPANTS: 324 people aged 4-60 years admitted to or attending hospital or the general practitioner out of hours service with acute asthma; 164 (50%) were South Asian patients, 108 (34%) were white patients, and 52 (16%) were from other, largely African and Afro-Caribbean, ethnicities. INTERVENTION: Patient review in a nurse led clinic and liaison with general practitioners and practice nurses comprising educational outreach, promotion of guidelines for high risk asthma, and ongoing clinical support. Control practices received a visit promoting standard asthma guidelines; control patients were checked for inhaler technique. MAIN OUTCOME MEASURES: Percentage of participants receiving unscheduled care for acute asthma over one year and time to first unscheduled attendance. RESULTS: Primary outcome data were available for 319 of 324 (98%) participants. Intervention delayed time to first attendance with acute asthma (hazard ratio 0.73, 95% confidence interval 0.54 to 1.00; median 194 days for intervention and 126 days for control) and reduced the percentage of participants attending with acute asthma (58% (101/174) v 68% (99/145); odds ratio 0.62, 0.38 to 1.01). In analyses of prespecified subgroups the difference in effect on ethnic groups was not significant, but results were consistent with greater benefit for white patients than for South Asian patients or those from other ethnic groups. CONCLUSION: Asthma specialist nurses using a liaison model of care reduced unscheduled care for asthma in a deprived multiethnic health district. Ethnic groups may not benefit equally from specialist nurse intervention.

Adolescent↗

PubMed2002

Anxiety and depression in an older research population and their impact on clinical outcomes in a randomised controlled trial.

INTRODUCTION: Anxiety and depression are common in older people living in the community. The aim of the study was to investigate their impact on clinical outcomes during a randomised controlled trial investigating the cost benefits of influenza vaccination in fit and healthy, independent living 65-74 year olds. SUBJECTS AND METHODS: A total of 729 people were recruited. Participants completed the hospital anxiety and depression scale (HADS) and EuroQol EQ-5D quality of life questionnaire immediately before receiving vaccination and every two months for the next six months after this. Side effects three days after vaccination and Barthel score at baseline were also recorded. RESULTS: At baseline the prevalence of "definite" anxiety in this sample (HADS score > or =11) was 4% and 1.2% of individuals had definite depression (HADS score > or =11). Individuals with anxiety or depression (HADS score > or =8) were more likely to complain of systemic side effects after vaccination and have a lower Barthel index score (p<0.001). Quality of life as measured by the EQ-5D visual analogue scale was reduced (p<0.001) at all time periods in those individuals with both anxiety and depression (HADS score > or =8 on both scales). CONCLUSION: Although the prevalence of anxiety and depression in this sample was low, people with anxiety or depression were more likely to suffer from perceived side effects after influenza vaccine and have a lower Barthel and EQ-5D visual analogue score. In future studies the effect of anxiety and depression on older participants should be remembered and care taken to ensure that they do not affect results more than the intervention under study.

Aged↗

PubMed2003

Impact of the ICD-10 Primary Health Care (PHC) diagnostic and management guidelines for mental disorders on detection and outcome in primary care. Cluster randomised controlled trial.

BACKGROUND: The World Health Organization (WHO) ICD-10 Primary Health Care (PHC) Guidelines for Diagnosis and Management of Mental Disorders (1996) have not been evaluated in a pragmatic randomised controlled trial (RCT). AIMS: To evaluate the effect of local adaptation and dissemination of the guidelines. METHOD: Pragmatic, pair-matched, cluster RCT involving 30 practices. RESULTS: Guideline practices were less sensitive but more specific in identifying morbidity, but these differences were not significant. Guideline patients did not differ from usual-care patients on 12-item General Health Questionnaire scores at 3-month follow-up or in the proportion who were still cases. There were no significant differences in secondary outcomes. CONCLUSIONS: Attempts to influence clinician behaviour through a process of adaptation and extension of guidelines are unlikely to change detection rates or outcomes.

Adult↗