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1,219 results for “randomisation”
Data from: A randomised trial comparing the clinical effectiveness of different emergency department healthcare professionals in soft tissue injury management
OBJECTIVE: To evaluate the clinical effectiveness of soft tissue injury management by emergency nurse practitioners (ENPs) and extended scope physiotherapists (ESPs) compared to the routine care provided by doctors in a UK emergency department (ED). DESIGN: Randomised, pragmatic trial of equivalence. SETTING: One adult ED in England. PARTICIPANTS: 372 patients were randomised; 126 to the ESP group, 123 to the ENP group and 123 to the doctor group. Participants were adults (older than 16 years) presenting to the ED with a peripheral soft tissue injury eligible for management by any of the three professional groups. Patients were excluded if they had any of the following: injury greater than 72 hours old; systemic disease; dislocated joints; recent surgery; unable to give informed consent (eg, dementia), open wounds; major deformities; opiate analgesia required; concurrent chest/rib injury; neurovascular deficits and associated fracture. INTERVENTIONS: Patients were randomised to treatment by ESPs, ENPs or routine care provided by doctors (of all grades). MAIN OUTCOME MEASURES: Upper-limb and lower-limb functional scores, quality of life, physical well-being, preference-based health measures and the number of days off work. RESULTS: The clinical outcomes of soft tissue injury treated by ESPs and ENPs in the ED were equivalent to routine care provided by doctors. CONCLUSIONS: As all groups were clinically equivalent it is other factors such as cost, workforce sustainability, service provision and skill mix that become important. This result validates the role of the ENP, which is becoming established as an integral part of minor injuries care, and demonstrates that the ESP should be considered as part of the clinical skill mix without detriment to outcomes. ISRCTN-ISRCTN trials register number 70891354.
Data from: Quality of descriptions of treatments: a review of published randomised controlled trials
OBJECTIVES: To be useable in clinical practice, treatments studied in trials must provide sufficient information to enable clinicians and researchers to replicate. We sought to assess the completeness of treatment descriptions in published randomised controlled trials using a checklist and to determine the extent to which peer reviewers and editors comment on the quality of reporting of treatments. DESIGN: Cross-sectional study. SETTING: Trials published in the BMJ, a general medical journal. PARTICIPANTS: 51 trials published in the BMJ were independently evaluated by two raters using the checklist. Reviewers' and editors' comments were also assessed for statements on treatment descriptions. PRIMARY AND SECONDARY OUTCOME MEASURES: Proportion of trials rated as replicable (primary outcome). RESULTS: For 57% (29/51) of the papers, published treatment descriptions were not considered sufficient to allow replication. Most poorly described aspects were the actual procedures involved including the sequencing of the technique (what happened and when) and the physical or informational materials used (e.g. training materials): 53% and 43% not clear, respectively. For a third of treatments, the dose/duration of individual sessions was not clear and for a quarter the schedule (interval, frequency, duration, or timing) was not clear. Although the majority of problems were not picked up by reviewers and editors, when they were detected only about two-thirds were fixed before publication. CONCLUSIONS: Journals wanting to publish research of use to practicing health care professionals need to pay more attention to descriptions of treatments. Our checklist, may be useful for reviewers, and editors and could help ensure important details of treatments are provided before papers are in the public domain.
Data from: Randomised controlled trial of an education and support package for stroke patients and their carers
Objective: Tailoring stroke information and providing reinforcement opportunities are two strategies proposed to enhance the effectiveness of education. This study aimed to evaluate the effects of an education package which utilised both strategies on the knowledge, health and psychosocial outcomes of stroke patients and carers. Design: Multisite, randomised trial comparing usual care with an education and support package. Setting: Two acute stroke units. Participants: Patients and their carers (N=138) were randomised (control n=67, intervention n=71) of which data for 119 participants (control n=59, intervention n=60) were analysed. Intervention: The package consisted of a computer-generated, tailored written information booklet and verbal reinforcement provided prior to, and for 3 months following, discharge. Outcome measures: Outcome measures were administered prior to hospital discharge and at 3-month follow-up by blinded assessors. The primary outcome was stroke knowledge (score range: 0–25). Secondary outcomes were: self-efficacy (1–10), anxiety and depression (0–21), ratings of importance of information (1–10), feelings of being informed (1–10), satisfaction with information (1–10), caregiver burden (carers) (0–13) and quality of life (patients) (1–5). Results: Intervention group participants reported better: self-efficacy for accessing stroke information (adjusted mean difference (MD) of 1.0, 95% CI 0.3 to 1.7, p=0.004); feeling informed (MD 0.9, 95% CI 0.2 to 1.6, p=0.008); and satisfaction with medical (MD 2.0, 95% CI 1.1 to 2.8, p<0.001); practical (MD 1.1, 95% CI 0.3 to 1.9, p=0.008), services and benefits (MD 0.9, 95% CI 0.1 to 1.8, p=0.036) and secondary prevention information (MD 1.7, 95% CI 0.9 to 2.5, p<0.001). There was no significant effect on other outcomes. Conclusions: Intervention group participants had improved self-efficacy for accessing stroke information and satisfaction with information, but other outcomes were not significantly affected. Evaluation of a more intensive intervention in a trial with a larger sample size is required to establish the value of an educational intervention that uses tailoring and reinforcement strategies.
Data from: Efficacy and safety of four weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial
BACKGROUND: Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting β2 agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma. TRIAL DESIGN: A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. METHODS: Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 μg OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 μg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0–4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV1) (23–24 h postdose; day 29) and wm FEV1 (0–4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 μg or placebo in a 2:1 ratio; all patients and investigators were blinded to active or placebo treatment. RESULTS: 60 patients (mean age 64 years) were randomised (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV1 per cent predicted was comparable between groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0–4 h postdose was similar between groups (difference: 0.6 beats per minute; 95% CI −3.9 to 5.1). More on-treatment AEs were reported in the FF/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs/Holters. The FF/VI group had statistically greater improvements compared with placebo in trough FEV1 (mean difference 183 ml) and 0–4 h postdose wm FEV1 (mean difference 236 ml). CONCLUSION: FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD.
Effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors: A randomised controlled trial
<p><span><span><span><b>Introduction:</b> </span></span></span></p> <p><span><span><span>Caring for stroke survivors at home creates high levels of care burden among family caregivers. As the nature of caregiving is multidimensional, previous initiatives at alleviating the care burden using a single approach have not been adequate. It was recommended that future studies focus on tailored interventions that address the needs of family caregivers and combine different approaches to relieve caregivers' burden. However, there is a lack of literature regarding interventions that incorporate these recommendations. The proposed study aims to evaluate the effect of a tailored multidimensional intervention developed by researchers to reduce the care burden among family caregivers of stroke survivors. Based on the perceived needs of family caregivers of stroke survivors, this intervention takes into account scientific recommendations to combine three different approaches: skill-building, psycho-education, and peer support. </span></span></span></p> <p><span><span><span><b>Methods and analysis</b>: Using a prospective, randomized, open-label, parallel-group design, 110 family caregivers were enrolled and randomly assigned to either the intervention group or the control group. The intervention was administered for 6 months and included three home visits and six home-based telephone calls, as well as one peer support session. Family caregivers of the control group received a simple educational booklet during only one home visit. The primary outcome is the care burden as measured <span>using </span>the Zarit Burden Interview. The secondary outcome is the quality of life. Outcomes evaluation was conducted at baseline (T0), Month 3 (T1), and Month 6 (T2). An Independent <i>t</i>-test will be performed to compare the mean values of study variables between the two groups at both T1 and T2. In addition, repeated-measures analysis of variance was conducted to assess changes in effects over time.</span></span></span></p>
Dataset from a randomised cross-over trial of QT response to hyperventilation-induced anxiety and diaphragmatic breathing in patients with stress cardiomyopathy and in control patients
<p>Dataset from a randomised cross-over trial that compared the QT response to hyperventilation-induced anxiety and diaphragmatic breathing in patients with stress cardiomyopathy and age- and sex-matched controls. Pre-registered in the Australia and New Zealand Clinical Trials Registry (ACTRN12618001812280).</p>
The impact of seat-height on 1-minute sit to stand test performance in COPD: A randomised cross-over trial
<p>Study question: Is there a difference in the number of repetitions on the 1-minute sit to stand (1MSTS) test using an individually adapted seatheight to 90-degree knee flexion (1MSTSIND), compared with the commonly used standard chair seat-height of 46cm (1MSTSSTD), in people with COPD.</p> <p>Intervention: After a learning 1MSTS, all participants performed two 1MSTS tests in random order on consecutive days. Participants were blinded, as they did not receive detailed information on the testing protocols.</p> <p>Results: 49 individuals with COPD (47% female) participated. In a regression model adjusted for sequence-period and subject, 1MSTS test performance was lower on 1MSTSIND compared to 1MSTSSTD (-0.78 repetitions, 95% CI, -1.47 to -0.11). In a second regression model additionally including the knee angle and an interaction term (1MSTSIND x knee angle), the interaction term was significant: 0.18 (95% CI, 0.05 to 0.30). The limits of agreement were between -5.5 to 4 repetitions.</p> <p>Conclusion: Although we observed a statistically significant difference between 1MSTSIND and 1MSTSSTD on a population level, the difference is negligible. Further studies may be needed to determine if individual adaptation of seat-height is needed for very tall or short people to ensure a valid assessment of 1MSTS test performance in COPD.</p>
GRIPP-2 checklist for 'Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT)'
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Data from: Perioperative medication management: expanding the role of the preadmission clinic pharmacist in a single centre, randomised controlled trial of collaborative prescribing
Objectives: Current evidence to support non-medical prescribing is predominantly qualitative, with little evaluation of accuracy, safety and appropriateness. Our aim was to evaluate a new model of service for the Australia healthcare system, of inpatient medication prescribing by a pharmacist in an elective surgery pre admission clinic (PAC) against usual care, using an endorsed performance framework. Design: Single centre, randomised controlled, two arm trial Setting: Elective surgery pre admission clinic in Brisbane based tertiary hospital Participants: Four hundred adults scheduled for elective surgery were randomised to intervention or control. Intervention: A pharmacist generated the inpatient medication chart to reflect the patient's regular medication, made a plan for medication perioperatively and prescribed VTE prophylaxis. In the control arm, the medication chart was generated by the Resident Medical Officers (RMO). Outcome Measures: Primary outcome was frequency of omissions and prescribing errors when compared against the medication history. The clinical significance of omissions was also analysed. Secondary outcome was appropriateness of VTE prophylaxis prescribing. Results: There were significantly less unintended omissions of medications: 11 of 887 (1.2%) intervention orders compared with 383 of 1217 (31.5%) control (p<0.001). There were significantly less prescribing errors involving selection of drug, dose or frequency: 2 in 857 (0.2%) intervention orders compared with 51 in 807 (6.3%) control (p<0.001). Orders with at least one component of the prescription missing, incorrect or unclear occurred in 20826 of 904 (235%) intervention orders and 445667 of 1034 (4364.5%) control (p<0.001). VTE prophylaxis on admission to the ward was appropriate in 93% of intervention patients and 90% control (p=0.29). Conclusion: Medication charts in the intervention arm contained fewer clinically significant omissions, and prescribing errors, when compared to control. There was no difference in appropriateness of VTE prophylaxis on admission between the two groups. Trial Registration: Registered with ANZCTR – ACTR Number ACTRN12609000426280
Data from: Can recombinant human thrombomodulin increase survival among patients with severe septic-induced disseminated intravascular coagulation: a single-centre, open-label, randomised controlled trial
Objective: To determine whether treatment with recombinant human thrombomodulin (rhTM) increases survival among severe septic patients with sepsis-induced disseminated intravascular coagulation (DIC) Design: Single-center, open-label, randomized controlled trial Setting: Single tertiary hospital Participant: 92 severe septic patients with sepsis-induced DIC Interventions: Patients with DIC scores ≥4, as defined by the Japanese Association of Acute Medicine, were diagnosed with DIC. Randomization was performed by the envelope method. The treatment group (rhTM group, n = 47) was intravenously treated with rhTM within 24 h of admission (day 0), and the control group (n = 45) did not receive any anti-coagulants, except in cases of deep venous thrombosis and pulmonary embolism. Primary and secondary measurements: Data were collected on days 0 (admission), 1, 2, 3, 5, 7, and 10. The primary outcome was survival at 28 and 90 days. The secondary endpoints comprised changes in DIC scores, platelet counts, D-dimer, antithrombin III (ATIII), and C-reactive protein (CRP) levels, and Sequential Organ Failure Assessment (SOFA) scores. All analyses were conducted on an intent-to-treat basis. Main Results: The 28-day survival rates were 84 and 83% in the control and rhTM groups, respectively (p = 0.745, log rank test). The 90-day survival rates were 73% and 72% in the control and rhTM groups, respectively (p = 0.94, log rank test). Meanwhile, the rates of recovery from DIC (<4) were significantly higher in the rhTM group than in the control group (p = 0.001, log rank test). Relative change from baseline of D-dimer levels were significantly lower in the rhTM group than in the control group, on day 3 and 5. Conclusion: rhTM treatment decreased D-dimer levels and facilitated DIC recovery in severe septic patients with sepsis-induced DIC. However, the treatment did not improve survival in this cohort.
Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study
ClinicalTrials.gov study NCT02092961. IPD Sharing: Not stated. Countries: 11. Publications: 0.
A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life
ClinicalTrials.gov study NCT06397651. IPD Sharing: YES. Countries: 1. Publications: 0.
Transform Randomised Control Trial in Uganda
ClinicalTrials.gov study NCT05882097. IPD Sharing: NO. Countries: 1. Publications: 0.
A Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients
ClinicalTrials.gov study NCT03258320. IPD Sharing: NO. Countries: 1. Publications: 0.
A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
ClinicalTrials.gov study NCT01897285. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Creatine Monohydrate for Mild Traumatic Brain Injury: a Randomised Controlled Pilot Study
ClinicalTrials.gov study NCT06644131. IPD Sharing: YES. Countries: 1. Publications: 0.
A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
ClinicalTrials.gov study NCT04215653. IPD Sharing: Not stated. Countries: 0. Publications: 2.
Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
ClinicalTrials.gov study NCT07267949. IPD Sharing: YES. Countries: 7. Publications: 0.
Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
ClinicalTrials.gov study NCT00626665. IPD Sharing: Not stated. Countries: 0. Publications: 1.
An In-situ, Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood: Protocol For an Exploratory Randomised Control Trial
ClinicalTrials.gov study NCT04810455. IPD Sharing: NO. Countries: 0. Publications: 1.
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OpenNeuro
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