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Results for “Randomised Controlled Trial”

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At least 1,099 records · Page 61Linked to original sources

PubMed2004

Beating heart against cardioplegic arrest studies (BHACAS 1 and 2): quality of life at mid-term follow-up in two randomised controlled trials.

AIMS: Off-pump coronary bypass grafting (OPCAB) has short-term benefits compared to conventional bypass grafting using the heart-lung machine (CABG-CPB) but may compromise longer term outcome. We aimed to compare generic and disease specific quality of life (QoL) two to four years after surgery in participants in two randomised controlled trials of OPCAB vs. CABG-CPB. METHODS AND RESULTS: Trial participants were sent four questionnaires (SF-36, EuroQol/EQ5D, Seattle Angina Questionnaire (SAQ) and Coronary Revascularisation Outcome Questionnaire (CROQ)) to assess generic and disease-specific quality of life (QoL). Of 401 participants, 22 (5.5%) had died; of the 379 survivors, 328 responded (86.5%; 159 CABG-CPB and 169 OPCAB). Median duration of follow-up was three years. QoL scores for both groups were very similar and differences between groups were not significant (p>0.05 for all questionnaires and dimensions). Summary SF-36 scores showed poorer than normal physical QoL but normal mental QoL. Among all responders, there was a tendency for CROQ scores (core total, physical and psychosocial functioning and satisfaction with treatment) to deteriorate with time after the operation (p< or =0.05). CONCLUSION: Two to four years after surgery, patients randomised to OPCAB and CABG-CPB had similar symptoms, generic and disease-specific QoL.

Angina Pectoris↗

PubMed2003

Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial.

BACKGROUND: As a consequence of mammographic breast screening programmes, ductal carcinoma in situ is diagnosed with increasing frequency. Mastectomy for localised ductal carcinoma in situ is thought to be an over-treatment by many physicians, but there is much controversy as to whether complete local excision alone is sufficient. We aimed to assess the effectiveness of adjuvant radiotherapy and tamoxifen. METHODS: We used a 2x2 factorial design in a randomised controlled trial. Between May, 1990, and August, 1998, 1701 patients recruited from screening programmes were randomised to both treatments in combination or singly, or to none, or to either one (eg, radiotherapy) with an elective decision to give or to withhold the other (ie, in this case tamoxifen). Patients had complete surgical excision of the lesion confirmed by specimen radiography and histology. Patients have been followed up at least once a year. Median follow-up was 52.6 (range 2.4-118.3) months. Our primary endpoint was the incidence of ipsilateral invasive disease. FINDINGS: Ipsilateral invasive disease was not reduced by tamoxifen but recurrence of overall ductal carcinoma in situ was decreased (hazard ratio 0.68 [0.49-0.96]; p=0.03). Radiotherapy reduced the incidence of ipsilateral invasive disease (0.45 [0.24-0.85]; p=0.01) and ipsilateral ductal carcinoma in situ (0.36 [0.19-0.66]; p=0.0004), but there was no effect on the occurrence of contralateral disease. There was no evidence of interaction between radiotherapy and tamoxifen. INTERPRETATION: Radiotherapy can be recommended for patients with ductal carcinoma in situ treated by complete local excision; however, there is little evidence for the use of tamoxifen in these women.

Antineoplastic Agents, Hormonal↗

PubMed2006

Randomised controlled trial of unsolicited occupational therapy in community-dwelling elderly people: the LOTIS trial.

OBJECTIVE: The objective of this trial, the Leiden 85-Plus Occupational Therapy Intervention Study (LOTIS), was to assess whether unsolicited occupational therapy, as compared to no therapy, can decelerate the increase in disability in high-risk elderly people. DESIGN: This was a randomised controlled trial with 2-y follow-up. SETTING: The study took place in the municipality of Leiden in the Netherlands. PARTICIPANTS: The participants were 402 community-dwelling 85-y-old people, with a Mini-Mental State Examination score of >18 points at baseline. INTERVENTIONS: Participants in the intervention group were visited by an occupational therapist who provided training and education about assistive devices that were already present and who gave recommendations and information about procedures, possibilities, and costs of assistive devices and community-based services. Control participants were not visited by an occupational therapist. OUTCOME MEASURES: The primary outcome measure was the score achieved on the Groningen Activity Restriction Scale. Secondary outcome measures included self-evaluations of well-being and feelings of loneliness. RESULTS: THE PARTICIPANTS WERE EVENLY DIVIDED BETWEEN THE TWO GROUPS: 202 participants were allocated to the intervention group and 200 participants to the control group. Of the 202 participants randomised to occupational therapy, 55 participants declined the proposed intervention. An occupational therapist indicated that of the remaining 147 participants, 66 (45%) needed an occupational therapy intervention. A total of 44 new assistive devices and five community-based services were implemented. During follow-up there was a progressive increase in disability in the intervention group (mean annual increase, 2.0 points; SE 0.2; p < 0.001) and control group (mean annual increase, 2.1 points; SE 0.2; p < 0.001). The increase in disability was not significantly different between study groups (0.08 points; 95% CI, -1.1-1.2; p = 0.75). There was also no difference between study groups for any of the secondary outcome measures. CONCLUSION: Unsolicited occupational therapy in high-risk elderly participants does not decelerate the increase in disability over time.

Journal Article↗

PubMed2004

Randomised controlled trial of pelvic floor muscle exercises and manometric biofeedback for erectile dysfunction.

BACKGROUND: The pelvic floor muscles are active in normal erectile function. Therefore, it was hypothesised that weak pelvic floor muscles could be a cause of erectile dysfunction. AIMS: To compare the efficacy of pelvic floor muscle exercises and manometric biofeedback with lifestyle changes for men with erectile dysfunction. DESIGN OF STUDY: Randomised controlled trial. SETTING: The Somerset Nuffield Hospital, Taunton, United Kingdom. METHOD: Fifty-five men with erectile dysfunction (median age 59.2 years; range 22-78 years) were enrolled from a local urology clinic. Of these, 28 participants were randomised to an intervention group and engaged in pelvic floor exercises, as well as receiving biofeedback and suggestions for lifestyle changes. Twenty-seven controls were solely advised on lifestyle changes. Baseline, 3- and 6-month assessments were: erectile function domain of International Index of Erectile Function (IIEF), Partner's International Index of Erectile Function (PIIEF), Erectile Dysfunction-Effect on Quality of Life (ED-EQoL), anal manometry, digital anal measurements, and clinical assessment by an assessor blind to treatment allocation. After 3 months, the control group were transferred to the active arm. RESULTS: At 3 months, compared with controls, men in the intervention group showed significant mean increases in the erectile function domain of the IIEF (6.74 points, P = 0.004); anal pressure (44.16 cmH(2)O, P <0.001); and digital anal grades (1.5 grades, P <0.001). All showed further improvement in these outcomes at 6 months. Similar benefits were seen in men of the control arm after transfer to active treatment. A total of 22 (40.0%) participants attained normal function, 19 (34.5%) participants had improved erectile function, and 14 (25.5%) participants failed to improve. CONCLUSION: Pelvic floor muscle exercises and biofeedback are an effective treatment for men with erectile dysfunction.

Adult↗

PubMed2003

A randomised controlled trial comparing rehabilitation against standard therapy in multiple sclerosis patients receiving intravenous steroid treatment.

BACKGROUND: There is evidence to support both the use of intravenous methylprednisolone (IVMP) in multiple sclerosis (MS) relapse and physiotherapy in the management of MS, but no studies have investigated the combination of steroids and rehabilitation together. OBJECTIVES: To evaluate the benefits of IVMP with planned, comprehensive multidisciplinary team (MDT) care compared to IVMP with standard care. METHODS: In this randomised controlled trial, patients confirmed to have had a definite MS relapse severe enough to warrant IVMP (1 g daily for three days) were randomised to two groups. The control group was managed according to the standard ward routine; the treatment group received planned coordinated multidisciplinary team assessment and treatment. Baseline assessments, including demographics and Expanded Disability Status Scale (EDSS) were carried out on both groups. The primary outcome measures were Guy's Neurological Disability Scale (GNDS), and Amended Motor Club Assessment (AMCA). The secondary measures were the Barthel Index (BI), Human Activity Profile (HAP), and Short Form Item 36 Health Survey (SF-36). All measures have published data on reliability and validity. Measures were administered at one and three months. RESULTS: Forty subjects, including 27 females, completed data collection. There were no significant differences between the two groups at baseline. Results showed statistically significant differences in GNDS (p = 0.03), AMCA (p = 0.03), HAPM (p < 0.01), HAPA (p = 0.02), and BI (p = 0.02) at three months in favour of planned MDT care. CONCLUSION: This study indicates that combining steroids with planned MDT care is superior to administering them in a standard neurology or day ward setting. Further research is necessary in order to confirm this finding.

Adult↗

PubMed2001

Randomised controlled trial evaluating the effectiveness of behavioural interventions to modify cardiovascular risk factors in men and women with impaired glucose tolerance: outcomes at 6 months.

AIMS: To evaluate the efficacy of interventions to promote a healthy diet and physical activity in people with impaired glucose tolerance (IGT). METHODS: A randomised controlled trial in Newcastle upon Tyne, UK, 1995-98. Participants included 67 adults (38 men; 29 women) aged 24-75 years with IGT. The intervention consisted of regular diet and physical activity counselling based on the stages of change model. Main outcome measures were changes between baseline and 6 months in nutrient intake; physical activity; anthropometric and physiological measurements including serum lipids; glucose tolerance; insulin sensitivity. RESULTS: The difference in change in total fat consumption was significant between intervention and control groups (difference -21.8 (95% confidence interval (CI) -37.8 to -5.8) g/day, P=0.008). A significantly larger proportion of intervention participants reported taking up vigorous activity than controls (difference 30.1, (95% CI 4.3--52.7)%, P=0.021). The change in body mass index was significantly different between groups (difference -0.95 (95% CI -1.5 to -0.4) kg/m(2), P=0.001). There was no significant difference in change in mean 2-h plasma glucose between groups (difference -0.19 (95% CI -1.1 to 0.71) mmol/l, NS) or in serum cholesterol (difference 0.02 (95% CI -0.26 to 0.31) mmol/l, NS). The difference in change in fasting serum insulin between groups was significant (difference -3.4 (95% CI -5.8 to -1.1) mU/l, P=0.005). CONCLUSIONS: After 6 months of intensive lifestyle intervention in participants with IGT, there were changes in diet and physical activity, some cardiovascular risk factors and insulin sensitivity, but not glucose tolerance. Further follow-up is in progress to investigate whether these changes are sustained or augmented over 2 years.

Adult↗

PubMed2001

The effect of a biscuit with red palm oil as a source of beta-carotene on the vitamin A status of primary school children: a comparison with beta-carotene from a synthetic source in a randomised controlled trial.

OBJECTIVE: To determine the effect of a biscuit with red palm oil as a source of beta-carotene on the vitamin A status of primary school children and to compare this with the effect of a biscuit with beta-carotene from a synthetic source. DESIGN: Randomised controlled trial. SETTING: A rural community in KwaZulu-Natal, South Africa. SUBJECTS: A total of 437 primary school children, aged 5--11 y; 400 completed the study. INTERVENTION: Subjects were randomly assigned to one of three groups, receiving, respectively: (i) a placebo biscuit; (ii) a biscuit with synthetic beta-carotene as a vitamin A fortificant (SB); (iii) a biscuit with red palm oil as a source of beta-carotene (PB); SB and PB supplied 30% of the RDA for vitamin A per serving of three biscuits. Biscuits were distributed daily during the school week; vitamin A status was assessed at baseline and after 3 months. RESULTS: There was a significant improvement in serum retinol compared to the control group in both the SB and PB groups (P<0.005); the treatment effect for the two groups was equivalent (difference in treatment effect 0.62 microg/dl, with a 90% CI -0.33--1.57). CONCLUSIONS: A biscuit with red palm oil as a source of beta-carotene is as effective as a biscuit with synthetic beta-carotene in improving the vitamin A status of primary school children. The additional qualities of red palm oil (ie no trans fatty acids; rich source of antioxidants) make it an excellent alternative fortificant for addressing vitamin A deficiency.

Anthropometry↗

PubMed2000

A randomised controlled trial comparing birthing centre care with delivery suite care in Adelaide, Australia.

Birthing centre care offers women with a low risk of complication in pregnancy an alternative to conventional care for the birthing of their baby. It is important these two forms of care are appropriately assessed. A randomised controlled trial comparing the newly opened birthing centre with the established conventional delivery suite was conducted at the then Queen Victoria Hospital, Adelaide, South Australia. The outcomes measured included maternal satisfaction, costs and clinical outcomes both for mother and baby which related to the need for Caesarean section, episiotomy or tear rate and method of feeding. Two hundred and one women attending the hospital's antenatal clinic were randomly allocated to either birthing centre or delivery suite care. One hundred women were allocated to the birthing centre. No differences were found in either group related to clinical outcomes or costs. The only difference in maternal satisfaction was the choice women made for their next birth. More women in the birthing centre group felt they were encouraged to breastfeed immediately after birth. While the numbers in this study were too small to detect any but large differences in outcome, birthing centre care should remain an option for women and further studies undertaken with larger numbers.

Adult↗

PubMed2006

Surgery for non-small cell lung cancer: systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Surgery is considered the treatment of choice for patients with resectable stage I and II (and some patients with stage IIIA) non-small cell lung cancer (NSCLC), but there have been no previously published systematic reviews. METHODS: A systematic review and meta-analysis of randomised controlled trials was conducted to determine whether surgical resection improves disease specific mortality in patients with stages I-IIIA NSCLC compared with non-surgical treatment, and to compare the efficacy of different surgical approaches. RESULTS: Eleven trials were included. No studies had untreated control groups. In a pooled analysis of three trials, 4 year survival was superior in patients undergoing resection with stage I-IIIA NSCLC who had complete mediastinal lymph node dissection compared with lymph node sampling (hazard ratio estimated at 0.78 (95% CI 0.65 to 0.93)). Another trial reported an increased rate of local recurrence in patients with stage I NSCLC treated with limited resection compared with lobectomy. One small study reported a survival advantage among patients with stage IIIA NSCLC treated with chemotherapy followed by surgery compared with chemotherapy followed by radiotherapy. No other trials reported significant improvements in survival after surgery compared with non-surgical treatment. CONCLUSION: It is difficult to draw conclusions about the efficacy of surgery for locoregional NSCLC because of the small number of participants studied and methodological weaknesses of the trials. However, current evidence suggests that complete mediastinal lymph node dissection is associated with improved survival compared with node sampling in patients with stage I-IIIA NSCLC undergoing resection.

Carcinoma, Non-Small-Cell Lung↗

PubMed2005

Assessment of an electronic voting system within the tutorial setting: a randomised controlled trial [ISRCTN54535861].

BACKGROUND: Electronic voting systems have been used in various educational settings with little measurement of the educational impact on students. The goal of this study was to measure the effects of the inclusion of an electronic voting system within a small group tutorial. METHOD: A prospective randomised controlled trial was run at the Royal Adelaide Hospital, a teaching hospital in Adelaide, Australia. 102 students in their first clinical year of medical school participated in the study where an electronic voting system was introduced as a teaching aid into a standard tutorial. Long-term retention of knowledge and understanding of the topics discussed in the tutorials was measured and student response to the introduction of the electronic voting system was assessed. RESULTS: Students using the electronic voting system had improved long-term retention of understanding of material taught in the tutorial. Students had a positive response to the use of this teaching aid. CONCLUSION: Electronic voting systems can provide a stimulating learning environment for students and in a small group tutorial may improve educational outcomes.

Adult↗

PubMed1999

Prevalence and characteristics of patients with severe mental illness and borderline intellectual functioning. Report from the UK700 randomised controlled trial of case management.

BACKGROUND: Low cognitive ability and developmental delays have been implicated in the causation of mental illness. AIMS: To examine the prevalence, socio-demographic characteristics, psychopathology and social functioning profiles of people with low intelligence and recurrent psychotic illness. METHOD: A multi-centre randomised controlled trial of case management provided the opportunity to explore associations between mental illness and borderline intellectual functioning (assessed using the National Adult Reading test). RESULTS: Overall prevalence of borderline intelligence was 18%. Significant positive associations were shown with: being Black Caribbean; having a father who worked in a manual occupation; lower educational achievement; having had special education; longer course of illness. Those with borderline intelligence had greater disability and were more likely to suffer extrapyramidal side-effects and show evidence of negative symptoms. Educational achievement, history of special education and social class were the best socio-demographic predictors of intellectual level. CONCLUSIONS: Many patients who attend generic psychiatric services have considerable intellectual deficits. This may lead to difficulties in other domains of adaptive functioning, and merits further investigation as well as clinical vigilance.

Adolescent↗

PubMed2006

Multifactorial day hospital intervention to reduce falls in high risk older people in primary care: a multi-centre randomised controlled trial [ISRCTN46584556].

Falls in older people are a major public health concern in terms of morbidity, mortality and cost. Previous studies suggest that multifactorial interventions can reduce falls, and many geriatric day hospitals are now offering falls intervention programmes. However, no studies have investigated whether these programmes, based in the day hospital are effective, nor whether they can be successfully applied to high-risk older people screened in primary care. The hypothesis is that a multidisciplinary falls assessment and intervention at Day hospitals can reduce the incidence of falls in older people identified within primary care as being at high risk of falling. This will be tested by a pragmatic parallel-group randomised controlled trial in which the participants, identified as at high risk of falling, will be randomised into either the intervention Day hospital arm or to a control (current practice) arm. Those participants preferring not to enter the full randomised study will be offered the opportunity to complete brief diaries only at monthly intervals. This data will be used to validate the screening questionnaire. Three day hospitals (2 Nottingham, 1 Derby) will provide the interventions, and the University of Nottingham's Departments of Primary Care, the Division of Rehabilitation and Ageing Unit, and the Trent Institute for Health Service Research will provide the methodological and statistical expertise. Four hundred subjects will be randomised into the two arms. The primary outcome measure will be the rate of falls over one year. Secondary outcome measures will include the proportion of people experiencing at least one fall, the proportion of people experiencing recurrent falls (>1), injuries, fear of falling, quality of life, institutionalisation rates, and use of health services. Cost-effectiveness analyses will be performed to inform health commissioners about resource allocation issues. The importance of this trial is that the results may be applicable to any UK day hospital setting. SITES: General practices across Nottinghamshire and Derbyshire. Day hospitals:Derbyshire Royal Infirmary (Southern Derbyshire Acute Hospitals NHS Trust)Sherwood Day Service (Nottingham City Hospital Trust)Leengate Day Hospital (Queen's Medical Centre Nottingham University Hospital NHS Trust).

Journal Article↗

PubMed2004

Computerised patient-specific guidelines for management of common mental disorders in primary care: a randomised controlled trial.

BACKGROUND: A large proportion of people with depression and anxiety go unrecognised by their general practitioner (GP). Case-finding does not appear to be effective on its own. AIM: To compare the effectiveness of case-finding followed by computer-generated patient-specific guidelines with usual care for the management of common mental disorders in primary care. DESIGN OF STUDY: Individual patient randomised controlled trial. SETTING: Five general practices in Bristol and Cardiff. METHOD: 762 individuals aged >/= 16 years scoring >/= 12 on the Clinical Interview Schedule Revised were randomised. The experimental intervention required participants to complete a computerised psychosocial assessment that generated a report for the GP including patient-specific treatment recommendations. The control patients were treated as usual with access to locally agreed guidelines. RESULTS: Participants' 12-item General Health Questionnaire (GHQ) score dropped irrespective of treatment allocation. The experimental group had a significantly lower GHQ score at 6 weeks, but not at 6 months. Recovery at 6 months was 3% greater among those receiving the experimental intervention (95% confidence interval [CI] = -4 to 10). Treatment was not significantly associated with quality of life or patient satisfaction. CONCLUSION: Only small benefits are likely from using case-finding followed by patient-specific guidelines to improve clinical management of common mental disorders in primary care. However, depression and anxiety are important public health problems so the utility of such systems should be further investigated.

Adolescent↗

PubMed2001

A randomised controlled trial of four weeks versus seven weeks of pulmonary rehabilitation in chronic obstructive pulmonary disease.

BACKGROUND: Pulmonary rehabilitation programmes have been shown to improve both exercise tolerance and health status in patients with chronic obstructive pulmonary disease (COPD). The optimal duration for a pulmonary rehabilitation programme is, however, unknown. To assess whether the current pulmonary rehabilitation programme could be shortened a randomised controlled trial was conducted in 44 patients with COPD who were allocated to either a seven week or a four week course. METHODS: Patients were randomised to either our standard seven week twice weekly outpatient based programme or a comparable but shortened four week course. They were assessed at baseline and at completion by the Chronic Respiratory Questionnaire (CRQ), the Breathing Problems Questionnaire (BPQ), the incremental shuttle walking test (SWT), and the treadmill endurance test (TET). RESULTS: Twenty one patients (61% men) of mean (SD) age 68 (9.2) years and forced expiratory volume in one second ( FEV(1)) 1.08 (0.4) l completed a conventional seven week course and 23 (67% men) of mean (SD) age 69 (8.8) years and FEV(1) 1.03 (0.3) l completed a shortened four week course. Patients who completed the seven week rehabilitation programme had greater improvements in all outcome measures than those undertaking the four week course. These differences reached clinical and statistical significance for the total CRQ score, which was the primary outcome variable (mean difference (95% confidence intervals (CI) of difference) -0.61(-0.15 to -1.08), p<0.05), and the CRQ domains of dyspnoea (-0.80 (95% CI -0.13 to -1.48), p<0.05), emotion (-0.89 (95% CI -0.33 to -1.45), p<0.005), and mastery (-0.84 (95% CI -0.10 to -1.58), p<0.05). There were also trends towards greater improvements in exercise assessments in the seven week group but the differences did not reach statistical significance (SWT: mean difference -16.9 (95% CI 24.8 to -58.6), p=0.41; TET: geometric mean difference -1.21 (95% CI -0.60 to -2.47), p=0.56). CONCLUSIONS: A seven week course of pulmonary rehabilitation provides greater benefits to patients than a four week course in terms of improvements in health status. Larger prospective studies are required to determine the optimal duration of a pulmonary rehabilitation programme.

Aged↗

PubMed2003

Effects of a short outpatient rehabilitation treatment on disability of multiple sclerosis patients--a randomised controlled trial.

It is well known that neurorehabilitation can reduce disability or improve handicap of people with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of a short period (6 weeks) of a tailored, individualised outpatient rehabilitation program in people with progressive MS. A randomised-controlled trial was undertaken in patients with primary and secondary progressive MS referred to the Centro Sclerosi Multipla of Catania. One hundred and eleven patients were assessed at baseline and at 12 weeks with validated measures of disability (Functional Independence Measure (FIM)) and impairment (Expanded Disability Status Scale (EDSS) and Functional Systems Scale). Of the 111, 58 were randomly assigned to the treatment group and 53 to the control group. All patients had been previously trained in a home exercise program. Both groups were well matched for age, sex, disease duration and severity, disability and quality of life (Short Form-36). At the end of 6 weeks patients allocated to the rehabilitation treatment group showed significant improvement in their level of disability compared with the control group,while the level of impairment did not change. Thirty-two patients of the treatment group and four of the control group improved on the FIM by two or more steps at 12 weeks (p<0.0001). An improvement by 1 EDSS step occurred in only two patients of the treatment group and in one patient of the control group. Benefits were maintained for a further six weeks. This study demonstrates that a short outpatient rehabilitation treatment improves disability of MS patients, without changing their impairment and confirms the effectiveness of rehabilitation in people with MS.

Adult↗

PubMed2002

Physiotherapy for patients with mobility problems more than 1 year after stroke: a randomised controlled trial.

BACKGROUND: Community physiotherapy is often prescribed for stroke patients with long-term mobility problems. We aimed to assess the effectiveness of this treatment in patients who had mobility problems 1 year after stroke. METHODS: We screened 359 patients older than 50 years for a single-masked, randomised controlled trial to assess the effects of community physiotherapy. Assessments were made at baseline, 3, 6, and 9 months in 170 eligible patients assigned treatment or no intervention. The primary outcome measure was mobility measured by the Rivermead mobility index. Secondary outcome measures were gait speed, number of falls, daily activity (Barthel index scores), social activity (Frenchay activities index), hospital anxiety and depression scale, and emotional stress of carers (general health questionnaire 28). Analyses were by intention to treat. FINDINGS: Follow-up was available for 146 patients (86%). Changes in scores on the Rivermead mobility index (score range 0-15) differed significantly between treatment and control groups at 3 months (p=0.018), but only by a median of 1 point (95% CI 0-1), with an interpolated value of 0.55 (0.08-1.04). Gait speed was 2.6 m/min (0.30-4.95) higher in the treatment group at 3 months. Neither treatment effect persisted at 6-months' and 9-months' follow-up. Treatment had no effect on patients' daily activity, social activity, anxiety, depression, and number of falls, or on emotional stress of carers. INTERPRETATION: Community physiotherapy treatment for patients with mobility problems 1 year after stroke leads to significant, but clinically small, improvements in mobility and gait speed that are not sustained after treatment ends.

Accidental Falls↗

PubMed2003

Effects of coaching by community pharmacists on psychological symptoms of antidepressant users; a randomised controlled trial.

BACKGROUND: Community pharmacists strive to deliver pharmaceutical care to patients. At the moment, coaching of depressive primary care patients on taking their antidepressants (ADs) is not yet part of their standard care package. AIMS: To investigate the effects of coaching by community pharmacists on psychological symptoms. METHOD: A randomised controlled trial with a 6-month follow-up. OUTCOMES: psychological symptoms with the Hopkins Symptom Checklist (SCL). Intention-to-treat (ITT) was performed with (1) last observation carried forward and (2) with group mean imputation (GMI). RESULTS: Analyses with LOCF and GMI resulted in different findings. The LOCF method revealed that at the 6-month follow-up, the intervention patients were less depressed and less anxious than the controls. The intervention was particularly effective in patients with lower levels of education who received pharmacist's coaching. However, ITT with the GMI method showed no differences in psychological symptoms. Differences between LOCF and GMI were explained by the selective attrition in the intervention arm (attrition intervention patients had lower initial SCL-item scores on depression and anxiety than the completers) and by the higher attrition rate in controls. CONCLUSIONS: Our study indicates that the interpretation of the effects of an intervention on psychological symptoms can differ substantially by the way missing values are imputed. If both LOCF and GMI produce significant differences, efficacy can be concluded. If not, the effects based on ITT analyses with LOCF are based on artefacts. We recommend that positive intervention effects should only be reported when findings with LOCF and GMI are in accordance.

Adult↗

PubMed1996

A randomised controlled trial of early versus delayed use of amniotomy and oxytocin infusion in nulliparous labour.

OBJECTIVE: To compare routine amniotomy and early intravenous oxytocin (active management of labour) with a more selective use of amniotomy and oxytocin in women in true labour who received comparable continuous supportive midwifery care. DESIGN: Randomised controlled trial of nulliparous clinic patients in spontaneous labour at term. SETTING: Labour and delivery ward of a university teaching hospital. PARTICIPANTS: Three hundred and six parturients: 152 received active management of labour; 154 were more selectively managed. INTERVENTIONS: 1. Active management: early amniotomy, early use of oxytocin. 2. Selective intervention management: no routine amniotomy and more selective use of oxytocin. OUTCOME MEASURES: Use of oxytocin and amniotomy. Labour duration, mode of delivery. RESULTS: Maternal characteristics were comparable in both groups. Amniotomy was more often performed (91% versus 57%, P <0.01) and oxytocin more often used (53% versus 27%, P < 0.01) in the active management group. The first stage of labour, however, was only shortened by half an hour in the active management group (254 min versus 283 min, P = 0.087). Caesarean section rate (3.9% versus 2.6%), spontaneous vaginal delivery rate (78% versus 79%) and neonatal outcome were not significantly different between groups. CONCLUSION: Within a set-up of strict labour diagnosis and supportive midwifery care, routine amniotomy and early use of oxytocin offered no advantage over a more selective use of amniotomy and oxytocin in terms of mode of delivery and labour duration.

Adult↗