scholarly journals Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU)

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036476
Author(s):  
Andrew Jull ◽  
Angela Wadham ◽  
Chris Bullen ◽  
Varsha Parag ◽  
Carolina Weller ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Risk Difference ◽  
Complete Healing ◽  
Community Dwelling ◽  
Ulcer Area ◽  
Randomised Controlled

ObjectiveTo determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing.DesignPragmatic parallel group randomised controlled trial.SettingCommunity-dwelling participants.ParticipantsPeople aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm2 or both).InterventionWool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression.Primary and secondary outcome measuresHealing at 24 weeks based on blinded assessment of ulcer photographs. Other outcomes included time to complete healing, change in ulcer area to 24 weeks, change in health-related quality of life and incidence of adverse events.ResultsWe screened 1068 patients with VLU and randomised 143 participants (51.1% of target recruitment), 71 to the keratin dressing group and 72 to the usual care group.The mean age was 66.1 years (SD 15.9) and 53 participants (37.1%) were women. There were no significant differences between the groups on the primary outcome (risk difference −6.4%, 95% CI −22.5% to 9.7%), change in ulcer area (−1.9 cm2, 95% CI −16.5 to 12.8 cm2), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses. However, the direction of effect on the primary outcome was reversed in a per protocol analysis specified a priori (risk difference 6.2%, 95% CI −12.4% to 24.9%).ConclusionThe effect of adding a keratin dressing to the treatment regimen for prognostically slow-to-heal VLU remains unclear.Trial registration numberNCT02896725

A randomised controlled trial of intrapleural balloon intercostal chest drains to prevent drain displacement

2021 ◽  
pp. 2101753
Author(s):  
Rachel M Mercer ◽  
Eleanor Mishra ◽  
Radhika Banka ◽  
John P Corcoran ◽  
Cyrus Daneshvar ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Standard Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Problem ◽  
Outcome Data ◽  
Chest Drain ◽  
Drain Removal ◽  
Randomised Controlled

BackgroundChest drain displacement is a common clinical problem, occurring in 9–42% of cases and results in treatment failure or additional pleural procedures conferring unnecessary risk. A novel chest drain with an integrated intrapleural balloon may reduce the risk of displacement.MethodsProspective randomised controlled trial comparing the balloon drain to standard care (12 F chest drain with no balloon) with the primary outcome of objectively-defined unintentional or accidental chest drain displacement.Results267 patients were randomised (primary outcome data available in 257, 96.2%). Displacement occurred less frequently using the balloon drain (displacement 5/128, 3.9%; standard care displacement 13/129, 10.1%) but this was not statistically significant (Odds Ratio (OR) for drain displacement 0.36, 95% CI 0.13 to 1.0, χ2 1df=2.87, p=0.09). Adjusted analysis to account for minimisation factors and use of drain sutures demonstrated balloon drains were independently associated with reduced drain fall out rate (adjusted OR 0.27, 95% CI 0.08 to 0.87, p=0.028). Adverse events were higher in the balloon arm than the standard care arm (balloon drain 59/131, 45.0%; standard care 18/132, 13.6%; χ2 1df=31.3, p<0.0001).ConclusionBalloon drains reduce displacement compared with standard drains independent of the use of sutures but are associated with increased adverse events specifically during drain removal. The potential benefits of the novel drain should be weighed against the risks, but may be considered in practices where sutures are not routinely used.

Using Moxibustion in Primary Healthcare to Correct Non-Vertex Presentation: A Multicentre Randomised Controlled Trial

2013 ◽  
Vol 31 (1) ◽  
pp. 31-38 ◽  
Author(s):  
Jorge Vas ◽  
José Manuel Aranda-Regules ◽  
Manuela Modesto ◽  
María Ramos-Monserrat ◽  
Mercedes Barón ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Primary Healthcare ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Acupuncture Point ◽  
Care Group ◽  
Moxibustion Group ◽  
Vertex Presentation ◽  
Randomised Controlled

Objective To compare the effectiveness of additional moxibustion at point BL67 with moxibustion at a non-specific acupuncture point and with usual care alone to correct non-vertex presentation. Methods This was a multicentre randomised controlled trial in which 406 low-risk pregnant women with a fetus in ultrasound breech presentation, with a gestational age of 33–35 weeks, were assigned to (1) true moxibustion at point BL67 plus usual care; (2) moxibustion at SP1, a non-specific acupuncture point (sham moxibustion) plus usual care; or (3) usual care alone. The primary outcome was cephalic presentation at birth. Women were recruited at health centres in primary healthcare. Results In the true moxibustion group, 58.1% of the full-term presentations were cephalic compared with 43.4% in the sham moxibustion group (RR 1.34, 95% CI 1.05 to 1.70) and 44.8% of those in the usual care group (RR 1.29, 95% CI 1.02 to 1.64). The reduction in RR of the primary outcome in women allocated to the true moxibustion group compared with the usual care group was 29.7% (95% CI 3.1% to 55.2%) and the number needed to treat was 8 (95% CI 4 to 72). There were no severe adverse effects during the treatment. Conclusions Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus. Trial Registration Current Controlled Trials ISRCTN10634508.

scholarly journals Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting

BMJ ◽  
2021 ◽  
pp. e066952
Author(s):  
Annette Mollerup ◽  
Marius Henriksen ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Mette Kildevæld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Symptom Severity ◽  
Controlled Trial ◽  
Self Care ◽  
Community Dwelling ◽  
Care Group ◽  
Open Label ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Objective To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19. Design Non-drug, open label, randomised controlled trial. Setting Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021. Participants Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19. Intervention Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention. Main outcome measures Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days’ follow-up. Results 378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of −1.2 points (95% confidence interval −2.1 to −0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported. Conclusions In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores. Trial registration ClinicalTrials.gov NCT04530435 .

scholarly journals Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036300
Author(s):  
Shoumitro Deb ◽  
Lina Aimola ◽  
Verity Leeson ◽  
Mayur Bodani ◽  
Lucia Li ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Process Evaluation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

ObjectivesTo conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).DesignMulticentre, parallel design, placebo controlled (1:1 ratio) double-blind feasibility trial with an embedded process evaluation. No statistical comparison was performed between the two study groups.SettingFour neuropsychiatric and neurology outpatient clinics in London and Kent, UK.ParticipantsOur aim was to recruit 50 patients with TBI over 18 months. Follow-up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser).ResultsSix participants were randomised to the active arm of the trial and eight to the placebo arm over a 10-month period (28% of our target). Two participants withdrew because of adverse events. Twelve out of 14 (85.7%) patients completed a follow-up assessment at 12 weeks. At follow-up, the scores of all outcome measures improved in both groups. Placebo group showed numerically better score change according to the primary outcome MOAS. No severe adverse events were reported. The overall rate of adverse events remained low. Data from the process evaluation suggest that existence of specialised TBI follow-up clinics, availability of a dedicated database of TBI patients’ clinical details, simple study procedures and regular support to participants would enhance recruitment and retention in the trial. Feedback from participants showed that once in the study, they did not find the trial procedure onerous.ConclusionsIt was not feasible to conduct a successful randomised trial of risperidone versus placebo for post-TBI aggression using the methods we deployed in this study. It is not possible to draw any definitive conclusion about risperidone’s efficacy from such a small trial.Trial registration numberISRCTN30191436

scholarly journals Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e052169
Author(s):  
Yaseen M Arabi ◽  
Haytham Tlayjeh ◽  
Sara Aldekhyl ◽  
Hasan M Al-Dorzi ◽  
Sheryl Ann Abdukahil ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Study Groups ◽  
Institutional Review Boards ◽  
Invasive Ventilation ◽  
Non Invasive ◽  
Non Invasive Ventilation ◽  
Randomised Controlled

IntroductionNon-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality.Methods and analysisThis is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness.Ethics and disseminationApprovals are obtained from the institutional review boards of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings.Trial registration numberNCT04477668.

scholarly journals RESTORE—Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e031133 ◽  
Author(s):  
Peter Kent ◽  
P O'Sullivan ◽  
Anne Smith ◽  
Terry Haines ◽  
Amity Campbell ◽  
...  
Keyword(s):  
Physical Activity ◽  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Low Back ◽  
Functional Therapy ◽  
Randomised Controlled

IntroductionLow back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP.Methods and analysisPragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0–10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a ‘booster’ session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .Ethics and disseminationApproved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001396213).

scholarly journals Oseltamivir for coronavirus illness: post-hoc exploratory analysis of an open-label, pragmatic, randomised controlled trial in European primary care from 2016 to 2018

2020 ◽  
Vol 70 (696) ◽  
pp. e444-e449 ◽  
Author(s):  
Samuel Coenen ◽  
Alike W van der Velden ◽  
Daniela Cianci ◽  
Herman Goossens ◽  
Emily Bongard ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Exploratory Analysis ◽  
Open Label ◽  
Novel Coronavirus ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

BackgroundPatients infected with the novel coronavirus (SARS-CoV-2) are being treated empirically with oseltamivir, but there is little evidence from randomised controlled trials to support the treatment of coronavirus infections with oseltamivir.AimTo determine whether adding oseltamivir to usual care reduces time to recovery in symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2).Design and settingExploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries.MethodPatients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2), were randomised to usual care or usual care plus oseltamivir. The primary outcome was time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache.ResultsCoronaviruses (CoV-229E, CoV-OC43, CoV-KU1 and CoV-NL63) were identified in 308 (9%) out of 3266 randomised participants in the trial; 153 of these were allocated to usual care and 155 to usual care plus oseltamivir; the primary outcome was ascertained in 136 and 147 participants, respectively. The median time to recovery was shorter in patients randomised to oseltamivir: 4 days (interquartile range [IQR] 3–6) versus 5 days (IQR 3–8; hazard ratio 1.31; 95% confidence interval = 1.03 to 1.66; P = 0.026).ConclusionPrimary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone. This may be of relevance to the primary care management of COVID-19.

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