204 resultados para randomised controlled trials
Resumo:
Objective: To compare an accelerated intervention incorporating early therapeutic exercise after acute ankle sprains with a standard protection, rest, ice, compression, and elevation intervention.
Design: Randomised controlled trial with blinded outcome assessor.
Setting: Accident and emergency department and university based sports injury clinic.
Participants: 101 patients with an acute grade 1 or 2 ankle sprain.
Interventions: Participants were randomised to an accelerated intervention with early therapeutic exercise (exercise group) or a standard protection, rest, ice, compression, and elevation intervention (standard group).
Main outcome measures: The primary outcome was subjective ankle function (lower extremity functional scale). Secondary outcomes were pain at rest and on activity, swelling, and physical activity at baseline and at one, two, three, and four weeks after injury. Ankle function and rate of reinjury were assessed at 16 weeks.
Results: An overall treatment effect was in favour of the exercise group (P=0.0077); this was significant at both week 1 (baseline adjusted difference in treatment 5.28, 98.75% confidence interval 0.31 to 10.26; P=0.008) and week 2 (4.92, 0.27 to 9.57; P=0.0083). Activity level was significantly higher in the exercise group as measured by time spent walking (1.2 hours, 95% confidence interval 0.9 to 1.4 v 1.6, 1.3 to 1.9), step count (5621 steps, 95% confidence interval 4399 to 6843 v 7886, 6357 to 9416), and time spent in light intensity activity (53 minutes, 95% confidence interval 44 to 60 v 76, 58 to 95). The groups did not differ at any other time point for pain at rest, pain on activity, or swelling. The reinjury rate was 4% (two in each group).
Conclusion: An accelerated exercise protocol during the first week after ankle sprain improved ankle function; the group receiving this intervention was more active during that week than the group receiving standard care.
Resumo:
BACKGROUND:
In a previous randomised controlled phase 2 trial, intravenous infusion of salbutamol for up to 7 days in patients with acute respiratory distress syndrome (ARDS) reduced extravascular lung water and plateau airway pressure. We assessed the effects of this intervention on mortality in patients with ARDS.
METHODS:
We did a multicentre, placebo-controlled, parallel-group, randomised trial at 46 UK intensive-care units between December, 2006, and March, 2010. Intubated and mechanically ventilated patients (aged =16 years) within 72 h of ARDS onset were randomly assigned to receive either salbutamol (15 µg/kg ideal bodyweight per h) or placebo for up to 7 days. Randomisation was done by a central telephone or web-based randomisation service with minmisation by centre, pressure of arterial oxygen to fractional inspired oxygen concentration (PaO(2)/F(I)O(2)) ratio, and age. All participants, caregivers, and investigators were masked to group allocation. The primary outcome was death within 28 days of randomisation. Analysis was by intention-to-treat. This trial is registered, ISRCTN38366450 and EudraCT number 2006-002647-86.
FINDINGS:
We randomly assigned 162 patients to the salbutamol group and 164 to the placebo group. One patient in each group withdrew consent. Recruitment was stopped after the second interim analysis because of safety concerns. Salbutamol increased 28-day mortality (55 [34%] of 161 patients died in the salbutamol group vs 38 (23%) of 163 in the placebo group; risk ratio [RR] 1·47, 95% CI 1·03-2·08).
INTERPRETATION:
Treatment with intravenous salbutamol early in the course of ARDS was poorly tolerated. Treatment is unlikely to be beneficial, and could worsen outcomes. Routine use of ß-2 agonist treatment in ventilated patients with this disorder cannot be recommended.
Resumo:
Objective: A community-based randomized controlled trial (RCT) was conducted in urban areas characterized by high levels of disadvantage to test the effectiveness of the Incredible Years BASIC parent training program (IYBP) for children with behavioral problems. Potential moderators of intervention effects on child behavioral outcomes were also explored. Method: Families were included if the child (aged 32-88 months) scored above a clinical cutoff on the Eyberg Child Behavior Inventory (ECBI). Participants (n = 149) were randomly allocated on a 2:1 ratio to an intervention group (n = 103) or a waiting-list control group (n = 46). Child behavior, parenting skills, and parent well-being were assessed at baseline and 6 months later using parent-report and independent observations. An intention-to-treat analysis of covariance was used to examine postintervention differences between groups. Results: Statistically significant differences in child disordered behavior favored the intervention group on the ECBI Intensity (effect size = 0.7, p
Resumo:
This study compared high dose ranitidine versus low dose omeprazole with antibiotics for the eradication of H pylori. 80 patients (mean age 48 years, range 18-75) who had H pylori infection were randomised in an investigator-blind manner to either a two-week regime of omeprazole 20 mg daily, amoxycillin 500 mg tid and metronidazole 400 mg tid (OAM), or ranitidine 600 mg bd, amoxycillin 500 mg tid and metronidazole 400 mg tid (RAM), or omeprazole 20 mg daily and clarithromycin 500 mg tid (OC), or omeprazole 20 mg daily and placebo (OP). H pylori was eradicated in 6 of 19 patients in the OAM group (32%); 8 of 18 in the RAM group (44%), 4 of 15 in the OC group (27%); none of 18 in the OP group (0%). [<P0.005 for OAM, RAM, OC vs OP; P = N.S. between OAM, RAM, OC]. Overall metronidazole resistance was unexpectedly high at 58%. Eradication rates in metronidazole sensitive patients were 71% (5/7) and 100% (3/3) for OAM and RAM respectively. In conclusion, H pylori eradication rates using high dose ranitidine plus amoxycillin and metronidazole may be similar to that of low dose omeprazole in combination with the same antibiotics for omeprazole with clarithromycin. Overall eradication rates were low due to a high incidence of metronidazole resistance but were higher in metronidazole-sensitive patients. Even high dose ranitidine with two antibiotics achieves a relatively low eradication rate. These metronidazole-based regimens cannot be recommended in areas with a high incidence of metronidazole resistance.
Resumo:
Evidence supports the use of exercise for chronic low back pain (CLBP); however, adherence is often poor due to ongoing pain. Auricular acupuncture is a form of pain relief involving the stimulation of points on the outer ear corresponding with specific body parts. It may be a useful adjunct to exercise in managing CLBP; however, there is only limited evidence to support its use with this patient group.
Resumo:
Abstract
Background Physical inactivity is a major public health concern, and more innovative approaches are urgently needed to address it. The UK Government supports the use of incentives and so-called nudges to encourage healthy behaviour changes, and has encouraged business sector involvement in public health through the Public Health Responsibility Deal. To test the effectiveness of provision of incentives to encourage adults to increase their physical activity, we
recruited 406 adults from a workplace setting (office-based) to take part in an assessor-blind randomised controlled trial.
Methods
We developed the physical activity loyalty card scheme, which integrates a novel physical activity tracking system with web-based monitoring (palcard). Participants were recruited from two buildings at Northern Ireland’s main
government offices and were randomly allocated (grouped by building [n=2] to reduce contamination) to either incentive group (n=199) or no incentive group (n=207). We included participants aged 16–65 years, based at the worksite 4 days or more per week and for 6 h or more per day, and able to complete 15 min of moderate-paced walking (self-report). Exclusion criteria included having received specific advice by a general practitioner not to exercise. A statistician not involved in administration of the trial prepared a computer-generated random allocation sequence. Random assignments were placed in individually numbered, sealed envelopes by the statistician to ensure concealment of allocation. Only the assessor was masked to assignment. Sensors were placed along footpaths and the gym in the workplace. Participants scanned their loyalty card at the sensor when undertaking physical activity (eg, walking), which logged activity. Participants in the incentive group monitored their physical activity, collected points, and received rewards (retail vouchers) for minutes of physical activity completed over the 12-week intervention. Rewards were vouchers sponsored by local retailers. Participants in the no incentive group used their loyalty card to self-monitor their physical activity but were not able to earn points or receive rewards. The primary outcome was change in minutes of moderate to vigorous physical activity with the Global Physical Activity Questionnaire, measured at baseline, week 12, and 6 months. Activity was objectively measured with the tracking system over the 12-week intervention. Mann Whitney U tests were done to assess change between groups.
Findings
The mean age of participants was 43·32 years (SD 9·37), and 272 (67%) were women. We obtained follow-up data from 353 (87%) participants at week 12 and 341 (84%) at 6 months. At week 12, participants in the incentive group increased moderate to vigorous physical activity by a median of 60 min per week (IQR –10 to 120) compared with 30 min per week (–60 to 90) in the no incentive group (p=0·05). At 6 months, participants in the incentive group had
increased their moderate to vigorous physical activity by 30 min per week (–60 to 100) from baseline compared with 0 min per week (–115 to 1110) in the no incentive group (p=0·099). We noted no significant differences between groups
for use of loyalty card (p=0·18). Participants in the incentive group recorded a mean of 60·22 min (95% CI 50·90–69·55) of physical activity per week with their loyalty card on week 1 and 23·56 min (17·06–30·06) at week 12, which was similar to that for those in the no incentive group (59·74 min, 51·24–68·23, at week 1; 20·25 min, 14·45–26·06, at week 12; p=0·94 for differences between groups at week 1; p=0·45 for differences between groups at week 12).
Interpretation:
Financial incentives showed a short-term behaviour change in physical activity. This innovative study contributes to the necessary evidence base, and has important implications for physical activity promotion and business engagement in health. The optimum incentive-based approach needs to be established. Results should be interpreted with some caution as the analyses of secondary outcomes were not adjusted for multiple comparisons.
Resumo:
Purpose: To determine the efficacy of a custom made wheelchair simulation in training children to use a powered wheelchair (PWC). Design: Randomised controlled trial employing the 4C/ID-model of learning. Twenty-eight typically developing children (13M, 15F; mean age 6 years, SD 6 months) were assessed on their operation of a PWC using a functional evaluation rating scale. Participants were randomly assigned to intervention (8x 30minute training sessions using a joystick operated wheelchair simulation) or control conditions (no task), and were re-assessed on their PWC use following the intervention phase. Additional data from the simulation on completion times, errors and total scores were recorded for the intervention group. Results: Analysis of variance showed a main effect of time, with planned comparisons revealing a statistically significant change in PWC use for the intervention (p = 0.022) but not the control condition. Whilst the intervention group showed greater improvement than the controls this did not reach statistical significance. Multiple regression analyses showed that gender was predictive of pre-test (p = 0.005) functional ability. Implications: A simulated wheelchair task appears to be effective in helping children learn to operate a PWC. Greater attention should be given to female learners who underperformed when compared to their male counterparts. This low cost intervention could be easily employed at home to reduce PWC training times in children with motor disorders.
Resumo:
Objective: To assess whether a multifaceted intervention can reduce the number of prescriptions for antimicrobials for suspected urinary tract infections in residents of nursing homes. Design: Cluster randomised controlled trial. Setting: 24 nursing homes in Ontario, Canada, and Idaho, United States. Participants: 12 nursing homes allocated to a multifaceted intervention and 12 allocated to usual care. Outcomes were measured in 4217 residents. Interventions: Diagnostic and treatment algorithm for urinary tract infections implemented at the nursing home level using a multifaceted approach-small group interactive sessions for nurses, videotapes, written material, outreach visits, and one on one interviews with physicians. Main outcome measures: Number of antimicrobials prescribed for suspected urinary tract infections, total use of antimicrobials, admissions to hospital, and deaths. Results: Fewer courses of antimicrobials for suspected urinary tract infections per 1000 resident days were prescribed in the intervention nursing homes than in the usual care homes (1.17 v 1.59 courses; weighted mean difference -0.49, 95% confidence intervals -0.93 to -0.06). Antimicrobials for suspected urinary tract infection represented 28.4% of all courses of drugs prescribed in the intervention nursing homes compared with 38.6% prescribed in the usual care homes (weighted mean difference -9.6%, -16.9% to -2.4%). The difference in total antimicrobial use per 1000 resident days between intervention and usual care groups was not significantly different (3.52 v 3.93; weighed mean difference -0.37, -1.17 to 0.44). No significant difference was found in admissions to hospital or mortality between the study arms. Conclusion: A multifaceted intervention using algorithms can reduce the number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes.
Resumo:
Background: The Democratic Republic of Congo (DRC) has been home to the world’s deadliest con?ict since World War II and is reported to have the largest number of child soldiers in the world. Despite evidence of the debilitating impact of war, no group-based mental health or psychosocial intervention has been evaluated in a randomised controlled trial for psychologically distressed former child soldiers.
Method: A randomised controlled trial involving 50 boys, aged 13–17, including former child soldiers (n = 39) and other war-affected boys (n = 11). They were randomly assigned to an intervention group, or wait-list control group. The intervention group received a 15-session, group-based, culturally adapted Trauma-Focused Cognitive–Behavioural Therapy (TF-CBT) intervention. Assessment interviews were completed at baseline, postintervention and 3-month follow-up (intervention group).
Results: Analysis of Covariance (ANCOVA) demonstrated that, in comparison to the wait-list control group, the TF-CBT intervention group had highly signi?cant reductions in posttraumatic stress symptoms, overall psychosocial distress, depression or anxiety-like symptoms, conduct problems and a signi?cant increase in prosocial behaviour (p < .001 for all). Effect sizes were higher when former child soldier scores were separated for sub-analysis. Three-month follow-up of the intervention group found that treatment gains were maintained.
Conclusions: A culturally modi?ed, group-based TF-CBT intervention was effective in reducing posttraumatic stress and psychosocial distress in former child soldiers and other war-affected boys.
Resumo:
Aim: To determine whether internal limiting membrane (ILM) peeling is cost-effective compared with no peeling for patients with an idiopathic stage 2 or 3 full-thickness macular hole. Methods: A cost-effectiveness analysis was performed alongside a randomised controlled trial. 141 participants were randomly allocated to receive macular-hole surgery, with either ILM peeling or no peeling. Health-service resource use, costs and quality of life were calculated for each participant. The incremental cost per quality-adjusted life year (QALY) gained was calculated at 6 months. Results: At 6 months, the total costs were on average higher (£424, 95% CI -182 to 1045) in the No Peel arm, primarily owing to the higher reoperation rate in the No Peel arm. The mean additional QALYs from ILM peel at 6 months were 0.002 (95% CI 0.01 to 0.013), adjusting for baseline EQ-5D and other minimisation factors. A mean incremental cost per QALY was not computed, as Peeling was on average less costly and slightly more effective. A stochastic analysis suggested that there was more than a 90% probability that Peeling would be cost-effective at a willingness-to-pay threshold of £20 000 per QALY. Conclusion: Although there is no evidence of a statistically significant difference in either costs or QALYs between macular hole surgery with or without ILM peeling, the balance of probabilities is that ILM Peeling is likely to be a cost-effective option for the treatment of macular holes. Further long-term follow-up data are needed to confirm these findings.
