scholarly journals Study protocol for a randomised controlled trial examining the effect of blood and plasma donation on serum perfluoroalkyl and polyfluoroalkyl substance (PFAS) levels in firefighters

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e044833
Author(s):  
Gabriel Silver ◽  
Yordanka Krastev ◽  
Miriam K Forbes ◽  
Brenton Hamdorf ◽  
Barry Lewis ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health Effects ◽  
Whole Blood ◽  
Sulfonic Acid ◽  
Controlled Trial ◽  
Adverse Health Effects ◽  
Plasma Donation ◽  
Adverse Health ◽  
Study Results ◽  
Randomised Controlled

IntroductionPerfluoroalkyl and polyfluoroalkyl substances (PFAS) are a diverse group of compounds that have been used in hundreds of industrial applications and consumer products including aqueous film-forming foam (AFFF) for many years. Multiple national and international health and environmental agencies have accepted that PFAS exposures are associated with numerous adverse health effects. Australian firefighters have been shown to have elevated levels of PFAS in their blood, specifically perfluorooctane sulfonic acid (PFOS) and perfluorohexane sulfonic acid (PFHxS), due to the historical use of AFFF. While PFAS concentrations decline over time once the source of exposure has been removed, their potential adverse health effects are such that it would be prudent to develop an intervention to lower levels at a faster rate than occurs via natural elimination rates.Methods and analysisThis is a randomised controlled trial of current and former Australian firefighters in the Metropolitan Fire Brigade/Fire Rescue Victoria, and contractors, with previous occupational exposure to PFAS and baseline elevated PFOS levels. The study is investigating whether whole blood donation every 12 weeks or plasma donation every 6 weeks will significantly reduce PFAS levels, compared with a control group. We have used covariate-adaptive randomisation to balance participants’ sex and blood PFAS levels between the three groups and would consider a 25% reduction in serum PFOS and PFHxS levels to be potentially clinically significant after 12 months of whole blood or plasma donation. A secondary analysis of health biomarkers is being made of changes between screening and week 52 in all three groups.Ethics and disseminationThis trial has been approved by Macquarie University Human Research Ethics Committee (reference number: 3855), final protocol V.2 dated 12 June 2019. Study results will be disseminated via peer-reviewed publications and presentations at conferences.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12619000204145).

scholarly journals Additional Treatments to the Local tumour for metastatic prostate cancer-Assessment of Novel Treatment Algorithms (IP2-ATLANTA): protocol for a multicentre, phase II randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e042953
Author(s):  
Martin John Connor ◽  
Taimur Tariq Shah ◽  
Katarzyna Smigielska ◽  
Emily Day ◽  
Johanna Sukumar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lymph Node ◽  
Androgen Receptor ◽  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Metastatic Prostate Cancer ◽  
Controlled Trial ◽  
Pelvic Lymph Node ◽  
Study Results ◽  
Randomised Controlled

IntroductionSurvival in men diagnosed with de novo synchronous metastatic prostate cancer has increased following the use of upfront systemic treatment, using chemotherapy and other novel androgen receptor targeted agents, in addition to standard androgen deprivation therapy (ADT). Local cytoreductive and metastasis-directed interventions are hypothesised to confer additional survival benefit. In this setting, IP2-ATLANTA will explore progression-free survival (PFS) outcomes with the addition of sequential multimodal local and metastasis-directed treatments compared with standard care alone.MethodsA phase II, prospective, multicentre, three-arm randomised controlled trial incorporating an embedded feasibility pilot. All men with new histologically diagnosed, hormone-sensitive, metastatic prostate cancer, within 4 months of commencing ADT and of performance status 0 to 2 are eligible. Patients will be randomised to Control (standard of care (SOC)) OR Intervention 1 (minimally invasive ablative therapy to prostate±pelvic lymph node dissection (PLND)) OR Intervention 2 (cytoreductive radical prostatectomy±PLND OR prostate radiotherapy±pelvic lymph node radiotherapy (PLNRT)). Metastatic burden will be prespecified using the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease (CHAARTED) definition. Men with low burden disease in intervention arms are eligible for metastasis-directed therapy, in the form of stereotactic ablative body radiotherapy (SABR) or surgery. Standard systemic therapy will be administered in all arms with ADT±upfront systemic chemotherapy or androgen receptor agents. Patients will be followed-up for a minimum of 2 years. Primary outcome: PFS. Secondary outcomes include predictive factors for PFS and overall survival; urinary, sexual and rectal side effects. Embedded feasibility sample size is 80, with 918 patients required in the main phase II component. Study recruitment commenced in April 2019, with planned follow-up completed by April 2024.Ethics and disseminationApproved by the Health Research Authority (HRA) Research Ethics Committee Wales-5 (19/WA0005). Study results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03763253; ISCRTN58401737

scholarly journals Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019142 ◽  
Author(s):  
Kate Jolly ◽  
Jenny Ingram ◽  
Joanne Clarke ◽  
Debbie Johnson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Feasibility Study ◽  
Breast Feeding ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Study Results ◽  
Service Staff ◽  
Before And After ◽  
Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

Effect of spin in the abstract of a randomised controlled trial on physiotherapists’ perception of treatment benefit: a randomised controlled trial

2021 ◽  
pp. bmjebm-2021-111714
Author(s):  
Heppy Khanpara ◽  
V Prakash
Keyword(s):  
Randomised Controlled Trial ◽  
Beneficial Effect ◽  
Controlled Trial ◽  
Experimental Treatment ◽  
Medium Effect ◽  
Clinical Settings ◽  
Treatment Benefit ◽  
Experimental Intervention ◽  
Study Results ◽  
Randomised Controlled

ObjectiveTo assess the effect of spin in the abstract of a randomised controlled trial (RCT) on physiotherapists’ perception of treatment benefit evaluated in the trial.DesignParallel-group RCT.SettingPhysiotherapy departments in hospitals and clinics in India.ParticipantsPhysiotherapists working in clinical settings.InterventionsWe selected one abstract with high level of spin published in one of the core journals of physiotherapy and created two versions of the abstract, that is, with and without spin. We randomly assigned physiotherapists working in clinical settings (N=128) to read one version of the selected abstract, with or without spin. Participants were blinded to the study design, objectives and randomisation.Main outcome measuresPhysiotherapists’ interpretation of beneficial effect of the experimental treatment (0–10 scale) reported in the abstract. The secondary outcomes were clinicians’ perception of methodological rigour and the study importance, their interest in reading the full text, and their interest in running another trial evaluating this treatment.ResultsWe found a medium reduction in confidence of beneficial effect of the experimental treatment among physiotherapists who read the abstract without spin (mean score 4.3±2.8) compared with those who read the abstract with spin (mean score 6.14±2.6). The mean difference in scores between abstracts with and without spin was 1.8 (95% CI 0.8 to 2.8; p<0.001). For other outcomes measures studied there was no statistically significant effect.ConclusionsRemoval of spin in the abstract of RCT reporting statistically non-significant results have medium effect in improving physiotherapists’ accuracy of interpretation of study results. Spin contributes to clinicians’ positive perception about the benefit of experimental intervention tested in the trial despite the evidence showing no superiority of experimental intervention.Trial registration numberCTRI/2020/02/023557.

scholarly journals Feasibility and Health Effects of a 15-Week Combined Exercise Programme for Sedentary Elderly: A Randomised Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Tina-Thea Nielsen ◽  
Trine K. Møller ◽  
Lars L. Andersen ◽  
Mette K. Zebis ◽  
Peter R. Hansen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health Effects ◽  
Aerobic Fitness ◽  
Exercise Intensity ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Supervised Training ◽  
Home Based ◽  
Total Fat ◽  
Randomised Controlled

There is strong evidence that considerable health benefits can be achieved even with small amounts of physical activity. However, getting people to exercise regularly is a major challenge not least in the elderly population. This study investigated the feasibility and physiological health effects of a pragmatic 15-week exercise programme for sedentary elderly. In a single-blind randomised controlled trial, 45 sedentary 60-83-year-olds (25 women, 20 men) were randomly assigned (2:1 ratio) to a training group (TG, n=30) or a control group (CG, n=15). The training in TG consisted of a combination of exercise modalities (i.e., strength, aerobic fitness, stability, and flexibility training) performed once a week as supervised group-based training and a weekly home-based training for 15 weeks. Feasibility outcomes were exercise intensity, adherence, and adverse events. The primary outcome was change in aerobic fitness (VO2max/kg). Adherence was high (81%) for the supervised exercise and low (0%) for the home-based exercise. No acute injuries occurred in TG, but 4 subjects (13%) reported considerable joint pain related to training. Average heart rate (HR) during the supervised training was 104±12 beats/min (69.3±8.0%HRmax), with 3.9±7.3% of training time >90%HRmax. Intention-to-treat analyses revealed no between-group differences for aerobic fitness (P=0.790) or any secondary cardiovascular outcomes at 15-week follow-up (resting HR or blood pressure; P>0.05). Compared to CG, bodyweight (-2.3 kg, 95% CI -4.0 to -7.0; P=0.006), total fat mass (-2.0 kg, 95% CI -3.5 to -0.5; P=0.01), and total fat percentage (-1.6%, 95% CI -2.8 to -0.3; P=0.01) decreased in TG. The group-based supervised training had high adherence and moderate exercise intensity, whereas the home-based training was not feasible in this study population. This exercise programme performed once a week did not improve aerobic fitness. Thus, supervised training with more vigorous intensity control appears advisable. Clinical Study registration number is H-15016951.

scholarly journals Efficacy of a web-based self-help tool to reduce problem gambling in Switzerland: study protocol of a two-armed randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032110 ◽  
Author(s):  
Christian Baumgartner ◽  
Elena Bilevicius ◽  
Yasser Khazaal ◽  
Sophia Achab ◽  
Susanne Schaaf ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Problem Gambling ◽  
Medical Devices ◽  
Controlled Trial ◽  
Intervention Programme ◽  
Web Based ◽  
Related Disorder ◽  
Self Help ◽  
Study Results ◽  
Randomised Controlled

IntroductionThe past-year prevalence of problem gambling worldwide averages 2.3%. Switzerland exhibits a slightly lower past-year prevalence rate, of 1.1%, among adults. Only a minority of these adults attend outpatient treatment. Surveyed problem gamblers have explained that they wanted to handle the problem on their own. The option of a web-based self-help programme could potentially reach those users who hesitate to approach treatment centres and help them to reduce or stop their problem gambling. The effectiveness of such web-based interventions has been shown in other countries.Methods and analysisThis two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling. The active intervention programme, spanning 8 weeks, consists of nine modules developed to reduce gambling and attenuate psychopathological comorbidity, including depression, anxiety and stress-related disorder symptoms, relying on motivational interviewing and cognitive behavioural therapy. With a target sample size of 352, questionnaire data will be collected at baseline, and at 8 and 24 weeks after baseline. Primary outcomes will be the number of days one has gambled in the last 30 days. Secondary outcomes will include money and time spent on gambling activities, changes in gambling-related problems (Problem Gambling Severity Index, Gambling Symptom Assessment Scale), use of alcohol and cigarettes, and psychopathological comorbidity. All data analysis will comply with the intention-to-treat principle.Ethics and disseminationThe RCT will be conducted in accordance with the Declaration of Helsinki; the consort eHealth Guidelines for studies on medical devices; the European Directive on medical devices 93/42/EEC, Swiss Law and Swiss Regulatory Authority requirements. The study was approved by the ethics committee of the Canton of Zurich. Results will be published in a scientific peer-reviewed journal. Participants will be informed via e-mail about study results via a lay-person-friendly summary of trial findings.Trial registration numberCurrent Controlled Trials registry (ISRCTN16339434).

scholarly journals Examining the effects of enhanced provider–patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e015505 ◽  
Author(s):  
Liesbeth M van Vliet ◽  
Sandra van Dulmen ◽  
Bram Thiel ◽  
Gerard W van Deelen ◽  
Stephanie Immerzeel ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Clinical Care ◽  
Numeric Rating Scale ◽  
Study Results ◽  
Audio Recordings ◽  
Registration Number ◽  
Randomised Controlled ◽  
Care Ward

IntroductionPlacebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider’s communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients’ outcomes.Methods and analysisUsing a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse–patient interactions.Ethics and disseminationAlthough communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication.Trial registration numberNTR5994; Pre-results.

scholarly journals 1-year follow-up of neurofeedback treatment in adolescents with attention-deficit hyperactivity disorder: randomised controlled trial

BJPsych Open ◽  
2016 ◽  
Vol 2 (2) ◽  
pp. 107-115 ◽  
Author(s):  
Marleen Bink ◽  
Ilja L. Bongers ◽  
Arne Popma ◽  
Tieme W. P. Janssen ◽  
Chijs van Nieuwenhuizen
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Randomised Controlled Trial ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Treatment As Usual ◽  
Hyperactivity Disorder ◽  
Study Results ◽  
Randomised Controlled ◽  
Neurocognitive Measures

BackgroundEstimates of the effectiveness of neurofeedback as a treatment for attention-deficit hyperactivity disorder (ADHD) are mixed.AimsTo investigate the long-term additional effects of neurofeedback (NFB) compared with treatment as usual (TAU) for adolescents with ADHD.MethodUsing a multicentre parallel-randomised controlled trial design, 60 adolescents with a DSM-IV-TR diagnosis of ADHD receiving NFB+TAU (n=41) or TAU (n=19) were followed up. Neurofeedback treatment consisted of approximately 37 sessions of theta/sensorimotor rhythm (SMR)-training on the vertex (Cz). Outcome measures included behavioural self-reports and neurocognitive measures. Allocation to the conditions was unmasked.ResultsAt 1-year follow-up, inattention as reported by adolescents was decreased (range ηp2=0.23–0.36, P<0.01) and performance on neurocognitive tasks was faster (range ηp2=0.20–0.67, P<0.005) irrespective of treatment group.ConclusionsOverall, NFB+TAU was as effective as TAU. Given the absence of robust additional effects of neurofeedback in the current study, results do not support the use of theta/SMR neurofeedback as a treatment for adolescents with ADHD and comorbid disorders in clinical practice.

scholarly journals Investigation of predictors of interest in a brief mindfulness-based intervention and its effects in patients with psoriasis at a rehabilitation clinic (SkinMind): an observational study and randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e033952
Author(s):  
Laura Stadtmüller ◽  
Markus Eckardt ◽  
Christoph Zick ◽  
Joerg Kupfer ◽  
Christina Schut
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Observational Study ◽  
Controlled Trial ◽  
Present Moment ◽  
Self Compassion ◽  
Study Results ◽  
Randomised Controlled ◽  
Rehabilitation Clinic

IntroductionPsoriasis (PS) is a chronic inflammatory skin disease accompanied by reduced quality of life. Mindfulness is the ability to focus on the present moment without evaluation. Findings on the effects of 8-week mindfulness trainings in patients with PS reveal positive effects on the severity of the disease and quality of life. However, it remained unclear what distinguishes patients with PS interested in psychological interventions from those without interest and whether also a shorter, namely 2-week mindfulness-based intervention is beneficial in this patient group. This will be investigated with this study.Methods and analysesData will be collected at a rehabilitation clinic in Germany. The study is divided into two parts: study 1a is an observational study. Its aim is to investigate whether sociodemographic, skin-related and psychological factors are significant predictors of interest in a brief psychological intervention in 127 patients with PS. Study 1b is a randomised controlled trial, in which 60 patients (retrieved from study 1a) will be randomised to an intervention or control group (treatment as usual). The main outcome variables are mindfulness and self-compassion. In addition, mediation analyses will be used in an explorative manner to test whether there is a relationship between mindfulness/self-compassion and the severity of PS and whether it is mediated by itch catastrophising and fear of negative evaluation (first model) or perceived stress (second model).Ethics and disseminationThe study protocol has been approved by the University of Giessen. Study results will be disseminated by publication of the results at (inter) national conferences and in scientific journals.Trial registration numbersDRKS00017426 and DRKS00017429.

scholarly journals Prevention of postcontrast acute kidney injury after percutaneous transluminal angioplasty by inducing RenalGuard controlled furosemide forced diuresis with matched hydration: study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e021842 ◽  
Author(s):  
Lars J J Bolt ◽  
Tim Anton Sigterman ◽  
Atilla G Krasznai ◽  
Cees-Jan J M Sikkink ◽  
Geert-Willem H Schurink ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Lower Extremities ◽  
Transluminal Angioplasty ◽  
Urine Biomarkers ◽  
Forced Diuresis ◽  
Study Results ◽  
Randomised Controlled ◽  
Percutaneous Transluminal

IntroductionPercutaneous transluminal angioplasty (PTA) is often complicated due to postcontrast acute kidney injury (PC-AKI) in patients diagnosed with chronic kidney disease (CKD). Hydration therapy is the cornerstone in the prevention of PC-AKI. Furosemide forced diuresis with matched hydration using the RenalGuard system enables a steady balance between diuresis and hydration. A randomised controlled trial will be performed in order to investigate whether furosemide forced diuresis with matched hydration in combination with the RenalGuard system decreases incidence of PC-AKI in patients with CKD receiving a PTA of the lower extremities. Furthermore, we will investigate whether sampling of urine biomarkers 4 hours after intervention can detect PC-AKI in an earlier stage compared with the golden standard, serum creatinine 48–72 hours postintervention.Methods and analysisA single-centre randomised controlled trial will be conducted. Patients >18 years in need of a PTA of the lower extremities and diagnosed with CKD will be randomly assigned to receive either standard of care prehydration and posthydration or furosemide forced diuresis with matched hydration periprocedural using the RenalGuard system. Four hours postintervention, a urine sample will be collected of all participating patients. Serum creatinine will be sampled within 10 days prior to intervention as well as 1, 3 and 30 days postintervention. The primary endpoint is incidence of PC-AKI post-PTA. Secondary endpoint is the rise of urine biomarkers 4 hours postintervention.Ethics and disseminationStudy protocol is approved by the research ethics committee and institutional review board (reference number 16 T-201 and NL59809.096.16). Study results will be disseminated by oral presentation at conferences and will be submitted to a peer-reviewed journal. It is anticipated that study results will offer a solution to contrast-induced nephropathy in patients with CKD receiving a PTA of the lower extremities.Trial registration numberNTR6236; Pre-results.EudraCT number2016-005072-10

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