4,997 research outputs found
Intraperitoneal ciprofloxacin and rifampicin versus cephradine as initial treatment of CAPD-related peritonitis: a prospective randomized multicenter comparison (CIPPER trial)
No full textIntraperitoneal ciprofloxacin and rifampicin versus cephradine as initial treatment of CAPD-related peritonitis: a prospective randomized multicenter comparison (CIPPER trial)
No full textThe effect of patients’ preference on outcome in the EVerT cryotherapy versus salicylic acid for the treatment of plantar warts (verruca) trial
No full textBackground
Randomised controlled trials are widely accepted as the gold standard method to evaluate medical interventions, but they are still open to bias. One such bias is the effect of patient’s preference on outcome measures. The aims of this study were to examine whether patients’ treatment preference affected clearance of plantar warts and explore whether there were any associations between patients’ treatment preference and baseline variables in the EverT trial.
Methods
Two hundred and forty patients were recruited from University podiatry schools, NHS podiatry clinics and primary care. Patients were aged 12 years and over and had at least one plantar wart which was suitable for treatment with salicylic acid and cryotherapy. Patients were asked their treatment preference prior to randomisation. The Kruskal-Wallis test was performed to test the association between preference group and continuous baseline variables. The Fisher’s exact test was performed to test the association between preference group and categorical baseline variables. A logistic regression analysis was undertaken with verruca clearance (yes or no) as the dependent variable and treatment, age, type of verruca, previous treatment, treatment preference as independent variables. Two analyses were undertaken, one using the health professional reported outcome and one using the patient’s self reported outcomes. Data on whether the patient found it necessary to stop the treatment to which they had been allocated and whether they started another treatment were summarised by treatment group.
Results
Pre-randomisation preferences were: 10% for salicylic acid; 42% for cryotherapy and 48% no treatment preference. There was no evidence of an association between treatment preference group and either patient (p=0.95) or healthcare professional (p=0.46) reported verruca clearance rates. There was no evidence of an association between preference group and any of the baseline variables except gender, with more females expressing a preference for salicylic acid (p=0.004). There was no evidence that the number of times salicylic acid was applied was different between the preference groups at one week (p=0.89) or at three weeks (p=0.24). Similarly, for the number of clinic visits for cryotherapy (p=0.71)
Conclusions
This secondary analysis showed no evidence to suggest that patients’ baseline preferences affected verruca clearance rates or adherence with the treatment
Zinc Supplementation during Pregnancy: A Randomized Controlled Trial
No full textZinc deficiency during pregnancy has been related to adverse pregnancy outcomes. However, the results of zinc-supplementation trials have not been consistent in improvement of pregnancies outcomes. This study was undertaken to investigate whether zinc supplementation was associated with pregnancy complications in Iranian women during the last 2 trimesters. It also assessed the anthropometric measurements of infants at birth. A double-blind placebo-controlled trial was conducted in Ardabil Province located in northwest of Iran. One-hundred ninty-six pregnant women between 16-20 weeks of gestation were recruited from urban healthcare centres. These women had no evidence of hypertension, diabetes, renal disease, history of prematurity, premature rupture of membranes (PROM) or low birth weight (LBW) infants. They were randomly assigned to receive zinc (50 mg daily) or placebo until delivery. Basic information was collected on socioeconomic status, reproductive and disease histories before randomization. The subjects were monthly followed during pregnancy and maternal complications were carefully recorded. The weight, length and head circumference of each infant was measured within 24h of birth. Of the 196 women, 17 were excluded from the study (9 in the zinc group and 8 in the placebo group, NS). The supplementation had no significant effect on prematurity, preeclampcia, PROM and stillbirth as well as gestational age, infant length and head circumference. The incidence of low birth weight was significantly lower in those under Zinc than placebo (p = 0.01). Meanwhile, pregnancy-induced hypertension and intrauterine growth retardation (IUGR) were observed only in the placebo group. The birth weight was also higher in the zinc group than that in the placebo group (p = 0.03). Supplementation with 50mg elemental zinc during pregnancy improved birth weight but did not reduce maternal complications
Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
No full textBackgroundColchicine has been proposed as a treatment for COVID-19 based on its anti-inflammatory actions. We aimed to evaluate the efficacy and safety of colchicine in patients admitted to hospital with COVID-19.MethodsIn this streamlined, randomised, controlled, open-label trial, underway at 177 hospitals in the UK, two hospitals in Indonesia, and two hospitals in Nepal, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Patients were eligible for inclusion in the study if they were admitted to hospital with clinically suspected or laboratory confirmed SARS-CoV-2 infection and had no medical history that might, in the opinion of the attending clinician, put the patient at significant risk if they were to participate in the trial. Eligible and consenting adults were randomly assigned (1:1) to receive either usual standard of care alone (usual care group) or usual standard of care plus colchicine (colchicine group) using web-based simple (unstratified) randomisation with allocation concealment. Participants received colchicine 1 mg after randomisation followed by 500 μg 12 h later and then 500 μg twice a day by mouth or nasogastric tube for 10 days in total or until discharge. Dose frequency was halved for patients receiving a moderate CYP3A4 inhibitor (eg, diltiazem), patients with an estimated glomerular filtration rate of less than 30 mL/min per 1·73m2, and those with an estimated bodyweight of less than 70 kg. The primary outcome was 28-day mortality, secondary endpoints included time to discharge, the proportion of patients discharged from hospital within 28 days, and, in patients not on invasive mechanical ventilation at randomisation, a composite endpoint of invasive mechanical ventilation or death. All analyses were by intention-to-treat. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.FindingsBetween Nov 27, 2020, and March 4, 2021, 11 340 (58%) of 19 423 patients enrolled into the RECOVERY trial were eligible to receive colchicine; 5610 (49%) patients were randomly assigned to the colchicine group and 5730 (51%) to the usual care group. Overall, 1173 (21%) patients in the colchicine group and 1190 (21%) patients in the usual care group died within 28 days (rate ratio 1·01 [95% CI 0·93 to 1·10]; p=0·77). Consistent results were seen in all prespecified subgroups of patients. Median time to discharge alive (10 days [IQR 5 to >28]) was the same in both groups, and there was no significant difference in the proportion of patients discharged from hospital alive within 28 days (3901 [70%] patients in the colchicine group and 4032 [70%] usual care group; rate ratio 0·98 [95% CI 0·94 to 1·03]; p=0·44). In those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (1344 [25%] in the colchicine group vs 1343 [25%] patients in the usual care group; risk ratio 1·02 [95% CI 0·96 to 1·09]; p=0·47).InterpretationIn adults hospitalised with COVID-19, colchicine was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death.FundingUK Research and Innovation (Medical Research Council), National Institute of Health Research, and Wellcome Trust
‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial
No full textBackground - Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention.
Methods - Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one to one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation.
Results - We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16).
Conclusions - Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers
PACE-UP (Pedometer and consultation evaluation - UP) – a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45–75 years: study protocol for a randomised controlled trial
No full text© 2013 Harris et al.; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Background - Most adults do not achieve the 150 minutes weekly of at least moderate intensity activity recommended for health. Adults’ most common physical activity (PA) is walking, light intensity if strolling, moderate if brisker. Pedometers can increase walking; however, most trials have been short-term, have combined pedometer and support effects, and have not reported PA intensity. This trial will investigate whether pedometers, with or without nurse support, can help less active 45–75 year olds to increase their PA over 12 months. Methods/design: Design: Primary care-based 3-arm randomized controlled trial with 12-month follow-up and health economic and qualitative evaluations. Participants: Less active 45–75 year olds (n = 993) will be recruited by post from six South West London general practices, maximum of two per household and households randomised into three groups. Step-count and time spent at different PA intensities will be assessed for 7 days at baseline, 3 and 12 months by accelerometer. Questionnaires and anthropometric assessments will be completed. Intervention: The pedometer-alone group will be posted a pedometer (Yamax Digi-Walker SW-200), handbook and diary detailing a 12-week pedometer-based walking programme, using targets from their baseline assessment. The pedometer-plus-support group will additionally receive three practice nurse PA consultations. The handbook, diary and consultations include behaviour change techniques (e.g., self-monitoring, goal-setting, relapse prevention planning). The control group will receive usual care.
Outcomes: Changes in average daily step-count (primary outcome), time spent sedentary and in at least moderate intensity PA weekly at 12 months, measured by accelerometry. Other outcomes include change in body mass index, body fat, self-reported PA, quality of life, mood and adverse events. Cost-effectiveness will be assessed by the incremental cost of the intervention to the National Health Service and incremental cost per change in step-count and per quality adjusted life year. Qualitative evaluations will explore reasons for trial non-participation and the interventions’ acceptability. Discussion- The PACE-UP trial will determine the effectiveness and cost-effectiveness of a pedometer-based walking intervention delivered by post or practice nurse to less active primary care patients aged 45–75 years old. Approaches to minimise bias and challenges anticipated in delivery will be discussed.This project was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number HTA 10/32/02) and will be published in full in Health Technology Assessment
MANOVA modelling of a chiropractic longitudinal study using multiple imputation
No full textThe purpose of this report is to present the detailed statistical analysis of a randomised, placebo-controlled trial comparing two different treatment modalities to an intervention of no known benefit for people with acute or subacute thoracic spine pain.
The therapy arms consist of Spinal Manipulative Therapy (SMT) and Graston Technique (GT) and the placebo is a non-functional ultrasound. A placebo group was utilised because at present there are no proven treatments for non-specific thoracic pain. This trial is registered with the Australia and New Zealand Clinical Trials Registry. Ethics approval has been granted by Murdoch University Human Research and Ethics Committee, number 2007/274.
The aim of this three arm trial was to test the efficacy of SMT and GT as independent modalities compared to detuned ultrasound for the outcomes of pain and disability. The latter were measured using the Visual Analogue Scale (VAS) and a modified Oswestry Back Pain Disability Index. The study was conducted at the Murdoch University Chiropractic student clinic in Perth, Australia, and the protocol published in Crothers et al (2008).
In this report, Section 2 provides an initial exploratory analysis of the data, Section 3 outlines the statistical models used in the final analysis, Section 4 defines these models in mathematical terms, Section 5 discusses the management of missing values via multiple imputation and Section 6 presents the results of the statistical modelling and hypothesis tests. The clinical study will be published in full elsewhere
Bilateral and unilateral arm training improve motor function through differing neuroplastic mechanisms: a single-blinded randomized controlled trial
No full textBACKGROUND AND PURPOSE:
This randomized controlled trial tests the efficacy of bilateral arm training with rhythmic auditory cueing (BATRAC) versus dose-matched therapeutic exercises (DMTEs) on upper-extremity (UE) function in stroke survivors and uses functional magnetic resonance imaging (fMRI) to examine effects on cortical reorganization.
METHODS:
A total of 111 adults with chronic UE paresis were randomized to 6 weeks (3×/week) of BATRAC or DMTE. Primary end points of UE assessments of Fugl-Meyer UE Test (FM) and modified Wolf Motor Function Test Time (WT) were performed 6 weeks prior to and at baseline, after training, and 4 months later. Pretraining and posttraining, fMRI for UE movement was evaluated in 17 BATRAC and 21 DMTE participants.
RESULTS:
The improvements in UE function (BATRAC: FM Δ = 1.1 + 0.5, P = .03; WT Δ = -2.6 + 0.8, P < .00; DMTE: FM Δ = 1.9 + 0.4, P < .00; WT Δ = -1.6 + 0.7; P = .04) were comparable between groups and retained after 4 months. Satisfaction was higher after BATRAC than DMTE (P = .003). BATRAC led to significantly higher increase in activation in ipsilesional precentral, anterior cingulate and postcentral gyri, and supplementary motor area and contralesional superior frontal gyrus (P < .05). Activation change in the latter was correlated with improvement in the WMFT (P = .01).
CONCLUSIONS:
BATRAC is not superior to DMTE, but both rehabilitation programs durably improve motor function for individuals with chronic UE hemiparesis and with varied deficit severity. Adaptations in brain activation are greater after BATRAC than DMTE, suggesting that given similar benefits to motor function, these therapies operate through different mechanisms
Group CBT for people with schizophrenia
No full textIndividual cognitive behavioural interventions for psychosis are rapidly developing and are being shown to be effective. This paper examines the application of these interventions on a group basis. The nature of the group, treatment outcome and potential benefits of using this format are described. After the group intervention, all patients were less depressed, most had higher self-esteem and greater knowledge of schizophrenia, and half the group felt better able to cope with their symptoms. Patients reported feeling less isolated and two of the four group members stated a preference for group over individual treatment
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