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

Beneficial Effect ◽

Controlled Trial ◽

Experimental Treatment ◽

Medium Effect ◽

Clinical Settings ◽

Treatment Benefit ◽

Experimental Intervention ◽

Study Results ◽

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.

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 ◽

10.1136/bmjopen-2020-044833 ◽

2021 ◽

Vol 11 (5) ◽

pp. e044833

Author(s):

Gabriel Silver ◽

Yordanka Krastev ◽

Miriam K Forbes ◽

Brenton Hamdorf ◽

Barry Lewis ◽

...

Keyword(s):

Health Effects ◽

Whole Blood ◽

Sulfonic Acid ◽

Controlled Trial ◽

Adverse Health Effects ◽

Plasma Donation ◽

Adverse Health ◽

Study Results ◽

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).

A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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 ◽

10.1136/bmjopen-2020-042953 ◽

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 ◽

Phase Ii ◽

Metastatic Prostate Cancer ◽

Controlled Trial ◽

Pelvic Lymph Node ◽

Study Results ◽

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

Training to enhance psychiatrist communication with patients with psychosis (TEMPO): cluster randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.115.179499 ◽

2016 ◽

Vol 209 (6) ◽

pp. 517-524 ◽

Cited By ~ 32

Author(s):

Rose McCabe ◽

Paula John ◽

Jemima Dooley ◽

Patrick Healey ◽

Annie Cushing ◽

...

Keyword(s):

Therapeutic Relationship ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Medium Effect ◽

Secondary Outcome ◽

Shared Understanding ◽

Cluster Randomised ◽

Self Repair ◽

BackgroundA better therapeutic relationship predicts better outcomes. However, there is no trial-based evidence on how to improve therapeutic relationships in psychosis.AimsTo test the effectiveness of communication training for psychiatrists on improving shared understanding and the therapeutic relationship (trial registration: ISRCTN94846422).MethodIn a cluster randomised controlled trial in the UK, 21 psychiatrists were randomised. Ninety-seven (51% of those approached) out-patients with schizophrenia/schizoaffective disorder were recruited, and 64 (66% of the sample recruited at baseline) were followed up after 5 months. The intervention group received four group and one individualised session. The primary outcome, rated blind, was psychiatrist effort in establishing shared understanding (self-repair). Secondary outcome was the therapeutic relationship.ResultsPsychiatrists receiving the intervention used 44% more self-repair than the control group (adjusted difference in means 6.4, 95% CI 1.46–11.33, P<0.011, a large effect) adjusting for baseline self-repair. Psychiatrists rated the therapeutic relationship more positively (adjusted difference in means 0.20, 95% CI 0.03–0.37, P = 0.022, a medium effect), as did patients (adjusted difference in means 0.21, 95% CI 0.01–0.41, P = 0.043, a medium effect).ConclusionsShared understanding can be successfully targeted in training and improves relationships in treating psychosis.

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

BMJ Open ◽

10.1136/bmjopen-2017-019142 ◽

2018 ◽

Vol 8 (1) ◽

pp. e019142 ◽

Cited By ~ 7

Author(s):

Kate Jolly ◽

Jenny Ingram ◽

Joanne Clarke ◽

Debbie Johnson ◽

Heather Trickey ◽

...

Keyword(s):

Infant Feeding ◽

Feasibility Study ◽

Breast Feeding ◽

Controlled Trial ◽

Feasibility Trial ◽

Study Results ◽

Service Staff ◽

Before And After ◽

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.

Peri-implant soft tissue integration in humans – influence of materials: A study protocol for a randomised controlled trial and a pilot study results

Contemporary Clinical Trials Communications ◽

10.1016/j.conctc.2020.100643 ◽

2020 ◽

Vol 19 ◽

pp. 100643

Author(s):

Manon Borie ◽

France Lambert ◽

Geoffrey Lecloux ◽

Dieter Bosshardt ◽

Alejandro Barrantes ◽

...

Keyword(s):

Pilot Study ◽

Soft Tissue ◽

Study Protocol ◽

Controlled Trial ◽

Tissue Integration ◽

Study Results ◽

Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) – a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial

BMC Psychiatry ◽

10.1186/s12888-019-2297-y ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Trudie Chalder ◽

Meenal Patel ◽

Kirsty James ◽

Matthew Hotopf ◽

Philipp Frank ◽

...

Keyword(s):

Cost Effectiveness ◽

Health Service ◽

Social Adjustment ◽

Secondary Care ◽

Service Use ◽

Controlled Trial ◽

Physical Symptoms ◽

Medium Effect ◽

Abstract Background Persistent physical symptoms (PPS), also known as medically unexplained symptoms (MUS), affect approximately 50% of patients in secondary care and are often associated with disability, psychological distress and increased health care costs. Cognitive behavioural therapy (CBT) has demonstrated both short- and long-term efficacy with small to medium effect sizes for PPS, with larger treatment effects for specific PPS syndromes, including non-cardiac chest pain, irritable bowel syndrome (IBS) and chronic fatigue syndrome (CFS). Research indicates that PPS conditions share similar cognitive and behavioural responses to symptoms, such as avoidance and unhelpful beliefs. This suggests that a transdiagnostic approach may be beneficial for patients with PPS. Methods A randomised controlled trial (RCT) will be conducted to evaluate the efficacy and cost-effectiveness of a transdiagnostic CBT-based intervention for PPS. 322 participants with PPS will be recruited from secondary care clinics. Participants stratified by clinic and disability level will be randomised to CBT plus standard medical care (SMC) versus SMC alone. The intervention consists of 8 CBT sessions delivered by a qualified therapist over a period of 20 weeks. Outcomes will be assessed at 9, 20, 40- and 52-weeks post randomisation. Efficacy will be assessed by examining the difference between arms in the primary outcome Work and Social Adjustment Scale (WSAS) at 52 weeks after randomisation. Secondary outcomes will include mood, symptom severity and clinical global impression at 9, 20, 40 and 52 weeks. Cost-effectiveness will be evaluated by combining measures of health service use, informal care, loss of working hours and financial benefits at 52 weeks. Discussion This trial will provide a powered evaluation of the efficacy and cost-effectiveness of a transdiagnostic CBT approach versus SMC for patients with PPS. It will also provide valuable information about potential healthcare pathways for patients with PPS within the National Health Service (NHS). Trial registration ClinicalTrials.gov NCT02426788. Registered 27 April 2015. Overall trial status: Ongoing; Recruitment status: No longer recruiting.

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 ◽

10.1136/bmjopen-2019-032110 ◽

2019 ◽

Vol 9 (12) ◽

pp. e032110 ◽

Cited By ~ 1

Author(s):

Christian Baumgartner ◽

Elena Bilevicius ◽

Yasser Khazaal ◽

Sophia Achab ◽

Susanne Schaaf ◽

...

Keyword(s):

Problem Gambling ◽

Medical Devices ◽

Controlled Trial ◽

Intervention Programme ◽

Web Based ◽

Related Disorder ◽

Self Help ◽

Study Results ◽

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).

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 ◽

10.1136/bmjopen-2016-015505 ◽

2017 ◽

Vol 7 (11) ◽

pp. e015505 ◽

Cited By ~ 1

Author(s):

Liesbeth M van Vliet ◽

Sandra van Dulmen ◽

Bram Thiel ◽

Gerard W van Deelen ◽

Stephanie Immerzeel ◽

...

Keyword(s):

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.

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

BJPsych Open ◽

10.1192/bjpo.bp.115.000166 ◽

2016 ◽

Vol 2 (2) ◽

pp. 107-115 ◽

Cited By ~ 8

Author(s):

Marleen Bink ◽

Ilja L. Bongers ◽

Arne Popma ◽

Tieme W. P. Janssen ◽

Chijs van Nieuwenhuizen

Keyword(s):

Attention Deficit Hyperactivity Disorder ◽

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.