A randomized controlled trial to prevent patient lift and transfer injuries of health care workers. A pilot study to investigate the effects of electrical stimulation on recovery of hand function and sensation in subacute stroke patients. Randomized clinical trial of hand-assisted laparoscopic versus open Roux-en-Y gastric bypass for the treatment of morbid obesity. Evaluation of a stroke family support organiser: a randomized controlled trial. Cluster randomized pilot controlled trial of an occupational therapy intervention for residents with stroke in UK care homes. Effects of robot-assisted upper limb rehabilitation on daily function and real-world arm activity in patients with chronic stroke: a randomized controlled trial. Electrical stimulation of wrist and fingers for sensory and functional recovery in acute hemiplegia. A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials. Intervention among frequent attenders of the out-of-hours service: a stratified cluster randomized controlled trial.
Randomized controlled trial (RCT).
                To compare the effectiveness of training and equipment to reduce musculoskeletal injuries, increase comfort, and reduce physical demands on staff performing patient lifts and transfers at a large acute care hospital.
                Back injury to nursing staff during patient handling tasks is a major issue in health care. The value of mechanical assistive devices in reducing injuries to these workers is unclear.
                This three-armed RCT consisted of a "control arm," a "safe lifting" arm, and a "no strenuous lifting" arm. A medical, surgical, and rehabilitation ward were each randomly assigned to each arm. Both intervention arms received intensive training in back care, patient assessment, and handling techniques. Hence, the "safe lifting" arm used improved patient handling techniques using manual equipment, whereas the "no strenuous lifting" arm aimed to eliminate manual patient handling through use of additional mechanical and other assistive equipment.
                Frequency of manual patient handling tasks was significantly decreased on the "no strenuous lifting" arm. Self-perceived work fatigue, back and shoulder pain, safety, and frequency and intensity of physical discomfort associated with patient handling tasks were improved on both intervention arms, but staff on the mechanical equipment arm showed greater improvements. Musculoskeletal injury rates were not significantly altered.
                The "no strenuous lifting" program, which combined training with assured availability of mechanical and other assistive patient handling equipment, most effectively improved comfort with patient handling, decreased staff fatigue, and decreased physical demands. The fact that injury rates were not statistically significantly reduced may reflect the less sensitive nature of this indicator compared with the subjective indicators. Objectives.  1) To compare the effect of cyclic neuromuscular electrical stimulation (NMES) of the forearm and elbow extensor muscles with passive stretching exercises on hand function and sensation following stroke. 2) To inform sample size for a larger randomized controlled trial (RCT). Materials and Methods.  Twenty-two subjects with hemiplegia resulting from a stroke during the previous 12 months were randomly allocated into stimulation (treatment) and exercise (control) groups. Stimulation was applied to the elbow, and forearm extensor muscle groups of the hemiplegic arm for 12 weeks. Subjects in the control group were taught passive stretching exercises for the same period. The primary outcome measure was the Action Research Arm test (ARAT). Sensation was tested using two-point discrimination. Statistical analysis applied nonparametric analysis of covariance (ancova). Results.  Statistically significant between-group differences in change in ARAT scores were shown between the two groups after 12 weeks of treatment (p = 0.003) and following 12 further weeks without intervention (p = 0.012). There were no significant differences in sensation. Conclusions.  1) A significant treatment effect of electrical stimulation over passive exercise has been demonstrated in a group of 22 subacute stroke patients, randomized into two equal groups and further work identified which may help to improve recovery of hand function and sensation following stroke. 2) A sample size of 24 subjects in each group has been estimated assuming a two-sided test significance level of 5% with 80% power, primary outcome variability SD = 6.75, a minimum difference of ten ARAT score units, and a 10% dropout rate. : Roux-en-Y gastric bypass (RYGBP) has increased in popularity since the introduction of the laparoscopic procedure, but this approach requires extensive surgical skill and the learning curve is steep. The present study examined the suitability of hand-assisted laparoscopy for RYGBP.
                In a prospective trial, 50 patients (median age 38 years, body mass index 45 kg/m(2)) were randomized to either hand-assisted (n = 25) or open (n = 25) RYGBP. The hand-assisted device was introduced through a right subcostal incision. Laparoscopic staplers were also used in the open group, allowing a short upper midline incision. The gastrojejunostomy was made by means of a circular stapler and the Roux limb placed behind the colon and excluded stomach.
                The postoperative outcome, with respect to morphine consumption, complications, hospital stay (6 days) and weight loss, was similar in the two groups. The operating time was significantly longer in the hand-assisted group (150 versus 85 min; P < 0.001) but there was no conversion to open operation. One patient in the hand-assisted group was reoperated owing to leakage and one patient developed an incisional hernia after open RYGBP.
                The hand-assisted technique was feasible and allowed good working conditions in all patients. However, the postoperative outcome was excellent in both groups and there was no advantage to the hand-assisted technique.
                Copyright 2004 British Journal of Surgery Society Ltd. There is inconclusive evidence of the effectiveness of the Stroke Family Support Organiser (FSO) service. We report the results from a randomized controlled trial of the service.
                Stroke patients admitted to hospital and their informal caregivers were randomly allocated to receive the FSO service (n=126) or standard care (n=124). Outcome assessments were undertaken 4 and 9 months after recruitment with the General Health Questionnaire 12, Carer Strain Index, Barthel Index, Extended Activities of Daily Living scale, and a specially designed questionnaire to determine knowledge of stroke and satisfaction with services.
                There were no significant differences between groups in patients' mood and independence in personal or instrumental activities of daily living or caregivers' mood, strain, or independence. Patients in the intervention group were significantly more knowledgeable about whom to contact for stroke information, reducing the risk of stroke, practical help, community services, and emotional support. Patients in the intervention group were also significantly more satisfied with the stroke information received. Caregivers in the intervention group were significantly more knowledgeable about whom to contact for information on stroke, reducing the risk of stroke, community services, and emotional support. Caregivers in the intervention group were also significantly more satisfied with stroke information.
                The FSO service had no significant effect on mood, independence in activities of daily living, or reduction in caregiver strain, but it did increase knowledge of stroke and satisfaction with that knowledge. The results may not be representative of all FSO services, and the sample was small relative to the heterogeneity of the participants. However, results suggest that the policies and training procedures of FSOs need to be evaluated to ensure that a cost-effective service is being provided to stroke patients and their caregivers. A pilot evaluation of an occupational therapy intervention to improve self-care independence for residents with stroke-related disability living in care homes was the basis of this study.
                A cluster randomized controlled trial with care home as the unit of randomization was undertaken in Oxfordshire, UK. Twelve homes (118 residents) were randomly allocated to either intervention (6 homes, 63 residents) or control (6 homes, 55 residents). Occupational therapy was provided to individuals but included carer education. The control group received usual care. Assessments were made at baseline, postintervention (3 months) and at 6-months to estimate change using the Barthel Activity of Daily Living Index (BI) scores, "poor global outcome", (defined as deterioration in BI score, or death) and the Rivermead Mobility Index.
                At 3 months BI score in survivors had increased by 0.6 (SD 3.9) in the intervention group and decreased by 0.9 (2.2) in the control group; a difference of 1.5 (95% CI allowing for cluster design, -0.5 to 3.5). At 6 months the difference was 1.9 (-0.7 to 4.4). Global poor outcome was less common in the intervention group. At 3 months, 20/63 (32%) were worse/dead in the intervention group compared with 31/55 (56%) in the control group, difference -25% (-51% to 1%). At 6 months the difference was similar, -26% (-48% to -3%). Between-group changes in Rivermead Mobility Index scores were not significantly different.
                Residents who received an occupational therapy intervention were less likely to deteriorate in their ability to perform activities of daily living. To compare the outcome of robot-assisted therapy with dose-matched active control therapy by using accelerometers to study functional recovery in chronic stroke patients.
                Prospective, randomized, controlled trial. Setting: Stroke units in three medical centres. Subjects: Twenty patients post stroke for a mean of 22 months. Intervention: Robot-assisted therapy (n = 10) or dose-matched active control therapy (n = 10). All patients received either of these two therapies for 90-105 minutes each day, 5 days per week, for four weeks.
                Outcome measures included arm activity ratio (the ratio of mean activity between the impaired and unimpaired arm) and scores on the Fugl-Meyer Assessment Scale, Functional Independence Measure, Motor Activity Log and ABILHAND questionnaire.
                The robot-assisted therapy group significantly increased motor function, hemiplegic arm activity and bilateral arm coordination (Fugl-Meyer Assessment Scale: 51.20 ± 8.82, P = 0.002; mean arm activity ratio: 0.76 ± 0.10, P = 0.026; ABILHAND questionnaire: 1.24 ± 0.28, P = 0.043) compared with the dose-matched active control group (Fugl-Meyer Assessment Scale: 40.90 ± 13.14; mean arm movement ratio: 0.69 ± 0.11; ABILHAND questionnaire: 0.95 ± 0.43).
                Symmetrical and bilateral robotic practice, combined with functional task training, can significantly improve motor function, arm activity, and self-perceived bilateral arm ability in patients late after stroke. To investigate the effects of a short-term electrical stimulation in conjunction with neurodevelopmental exercises on sensory and functional recovery of hemiparetic upper limb in acute stroke patients.
                Controlled clinical trial with alternate allocation.
                Acute inpatient medical care setting of a university hospital.
                Thirty-six acute stroke patients (18 TENS group; 18 control group) who experienced their first stroke were studied.
                Both groups received 1 h/day neurodevelopmental exercises in accordance with Bobath for 10 days. In addition to exercises the TENS group received electrical stimulation of the wrist and finger extensors for 1 h.
                Kinaesthesia and position sense tests, a hand function test and a hand movement scale were performed before and after treatment.
                Both groups showed considerable improvement in kinaesthesia sense and position sense after treatment. Comparison of the two groups after treatment revealed that this difference was not significant (P> 0.05). Both groups showed improvement in hand movement scores (P< 0.05), whereas hand function improved only in the TENS group (P< 0.05).
                The results of this study indicated that additional stimulation of the hand and fingers leads to an improved sensorimotor outcome immediately after the intervention. Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55-2.58, P=0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P=0.0072). The change in anxiety score between the arms was also statistically significant (P=0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates. To investigate whether the number of frequent attenders (FA) contacts with the out-of-hours service can be reduced by deploying a combination of intervention strategies.
                A stratified cluster randomized controlled trial, each cluster containing a general practice and all its listed patients.
                The out-of-hours service in the county of Northern Jutland (490,000 inhabitants), Denmark.
                The following intervention strategies were deployed: predisposition, individual instruction, economic incitement, continuing medical education meetings, feedback/reminder, and patient-mediated intervention.
                An intervention group of 3500 patients and a control group of 4635 patients.
                Absolute and relative fall in the number of contacts with the out-of-hours service per patient after 6 and 12 months.
                Analysed by group, intervention patients saw a more pronounced decline in the number of contacts than controls, except for two outcomes. However, this difference was only significant after 12 months. For women aged 17-66 years with 5-9 contacts during the previous 12 months, the decrease was significantly more pronounced in the intervention group for all outcomes (p=0.004-0.042). However, for the rest of the subgroups the effect varied more, and in several cases it was more distinct in the control group.
                The data collected point towards an effect of intervention on the use of out-of-hours services even if the responses obtained were not uniform and unequivocal. However, one has to consider the problems of multiple comparisons and in conclusion no convincing effect of the intervention was found.
Despite the limited number of trials performed, meta-analysis demonstrated a statistically significant decrease in conversion rates among the hand assisted group. There was no difference in operating time or perioperative complication rates.  Additional adequately powered and methodologically sound trials are needed to determine if there is a clinically important difference in perioperative outcomes.  Due to significant costs associated with the use of hand-assist devices, economic analyses are also warranted.