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Prolong: a double-blind randomised placebo-controlled trial of broccoli sprout extract in women with early onset preeclampsia. A clinical trial protocol

Por: Langston-Cox · A. G. · Marshall · S. A. · Palmer · K. R. · Wallace · E. M.
Introduction

Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. There is a need for adjuvant, targeted therapies to improve outcomes. Broccoli sprout extract, rich in the antioxidant sulforaphane, reduces oxidative stress and placental secretion of the antiangiogenic factors that contribute to vascular dysfunction in preeclampsia. We propose a phase III trial investigating broccoli sprout extract. We will assess broccoli sprout extract in women with early onset (

Methods

A double-blind, placebo-controlled randomised trial will be conducted at Monash Health, Melbourne, Australia. One hundred and eighty women (45 each arm of each stratum) with early onset preeclampsia (defined as per Society for Obstetric Medicine of Australia and New Zealand guidelines) will be recruited. Consenting women will be randomised to receive an oral dose of either broccoli sprout extract (24 mg of activated sulforaphane) or identical placebo, twice daily until delivery. Maternal blood will be collected antenatally for measurement of biomarkers of preeclampsia, including soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor (PlGF), soluble endoglin (sEng) and activin A, as well as circulating sulforaphane metabolites. Maternal and perinatal outcomes will be monitored throughout. All clinical care decisions, including the timing of delivery, will be made by the treating team, blinded to treatment allocation. Participation in this trial will not affect routine care. At delivery, maternal and cord blood and placentae will be collected to measure sulforaphane metabolites and sFlt-1, PlGF, sEng and activin A.

Ethics and dissemination

Approval to conduct the trial has been granted by Monash Health Human Research and Ethics Committee (RES-18-0000-109A). Deidentified data will be published in peer-reviewed journals and presented at learnt society conferences, both nationally and internationally. This study has not yet commenced and is pre-results.

Trial registration number

ACTRN12618000216213

Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients

Por: McLean · K. A. · Mountain · K. E. · Shaw · C. A. · Drake · T. M. · Ots · R. · Knight · S. R. · Fairfield · C. J. · Sgro · A. · Skipworth · R. J. E. · Wigmore · S. J. · Potter · M. A. · Harrison · E. M.
Introduction

National data suggest that surgical site infection (SSI) complicates 2%–10% of general surgery cases, although the patient-reported incidence is much higher. SSIs cause significant patient morbidity and represent a significant burden on acute healthcare services, in a cohort predominantly suitable for outpatient management. Over three-quarters of UK adults now own smartphones, which could be harnessed to improve access to care. We aim to investigate if a smartphone-delivered wound assessment tool results in earlier treatment.

Methods and analysis

This is a randomised controlled trial aiming to recruit 500 patients across National Health Service (NHS) hospitals. All emergency abdominal surgery patients over the age of 16 who own smartphones will be considered eligible, with the exclusion of those with significant visual impairment. Participants will be randomised in a 1:1 ratio between standard postoperative care and the intervention – use of the smartphone tool in addition to standard postoperative care. The main outcome measure will be time-to-diagnosis of SSI with secondary outcome measures considering use of emergency department and general practitioner services and patient experience. Follow-up will be conducted by clinicians blinded to group allocation. Analysis of time-to-diagnosis will be by comparison of means using an independent two sample t-test.

Ethics and dissemination

This is the first randomised controlled trial on the use of a smartphone-delivered wound assessment tool to facilitate the assessment of SSI and the impact on time-to-diagnosis. The intervention is being used in addition to standard postoperative care. The study design and protocol were reviewed and approved by Southeast Scotland Research and Ethics Committee (REC Ref: 16/SS/0072 24/05/2016). Study findings will be presented at academic conferences, published in peer-reviewed journals and are expected in 2020. A written lay summary will be available to study participants on request.

Trial registration number

NCT02704897; Pre-results.

What Do Nurses Need to Practice Effectively in the Hospital Environment? An Integrative Review With Implications for Nurse Leaders

Abstract

Background

When staffing legislation was introduced, New Jersey nurse leaders recognized from the research and their years of clinical leadership experience that the work environment is a multidimensional concept and that staffing is not the only variable related to nurse and patient outcomes. Thus, an understanding of what nurses need in their hospital environment to practice nursing effectively was sought.

Aims

The aim of this study was to examine the evidence regarding clinical nurses’ perception of what they need to practice nursing effectively in the acute care hospital environment.

Methods

The following population, intervention, comparison, outcome question was used to search the literature databases PubMed, CINAHL, Johanna Briggs, and the Sigma Theta Tau Henderson Library: In the hospital environment what do nurses perceive as needed to practice nursing effectively? Specific search criteria and the Johns Hopkins nursing guidelines and tools were used to identify relative studies.

Results

The final review, which addressed what nurses in the hospital environment need to practice nursing effectively, included 25 articles: 20 were an evidence level III, and five were evidence level II. From this review, five key concepts were identified: Leadership, autonomy/decision making, respect/teamwork, resources/staffing, and organizational commitment to nursing.

Linking Evidence to Action

This integrative review, which explored nurses’ perceptions of what is needed to provide effective quality care, identified that providing quality care is multifactorial in nature. Resources, including but not limited to staffing, and leadership were identified as important by nurses as a key factor in supporting quality care. Nurses must be provided with resources and infrastructure to do their jobs, in an environment supported by authentic transformational leadership.

Optimizing bacterial DNA extraction in urine

by Matthew M. Munch, Laura C. Chambers, Lisa E. Manhart, Dan Domogala, Anthony Lopez, David N. Fredricks, Sujatha Srinivasan

Urine is an acceptable, non-invasive sample for investigating the human urogenital microbiota and for the diagnosis of sexually transmitted infections. However, low quantities of bacterial DNA and PCR inhibitors in urine may prevent efficient PCR amplification for molecular detection of bacteria. Furthermore, cold temperatures used to preserve DNA and bacteria in urine can promote precipitation of crystals that interfere with DNA extraction. Saline, Dulbecco’s Phosphate Buffered Saline, or Tris-EDTA buffer were added to urine from adult men to determine if crystal precipitation could be reversed without heating samples beyond ambient temperature. Total bacterial DNA concentrations and PCR inhibition were measured using quantitative PCR assays to compare DNA yields with and without buffer addition. Dissolution of crystals with Tris-EDTA prior to urine centrifugation was most effective in increasing bacterial DNA recovery and reducing PCR inhibition. DNA recovery using Tris-EDTA was further tested by spiking urine with DNA from bacterial isolates and median concentrations of Lactobacillus jensenii and Escherichia coli 16S rRNA gene copies were found to be higher in urine processed with Tris-EDTA. Maximizing bacterial DNA yield from urine may facilitate more accurate assessment of bacterial populations and increase detection of specific bacteria in the genital tract.

Are socioenvironmental factors associated with psychotic symptoms in people with first-episode psychosis? A cross-sectional study of a West London clinical sample

Por: Tibber · M. S. · Kirkbride · J. B. · Mutsatsa · S. · Harrison · I. · Barnes · T. R. E. · Joyce · E. M. · Huddy · V.
Objectives

To determine whether neighbourhood-level socioenvironmental factors including deprivation and inequality predict variance in psychotic symptoms after controlling for individual-level demographics.

Design

A cross-sectional design was employed.

Setting

Data were originally collected from secondary care services within the UK boroughs of Ealing, Hammersmith and Fulham, Wandsworth, Kingston, Richmond, Merton, Sutton and Hounslow as part of the West London First-Episode Psychosis study.

Participants

Complete case analyses were undertaken on 319 participants who met the following inclusion criteria: aged 16 years or over, resident in the study’s catchment area, experiencing a first psychotic episode, with fewer than 12 weeks’ exposure to antipsychotic medication and sufficient command of English to facilitate assessment.

Outcome measures

Symptom dimension scores, derived from principal component analyses of the Scale for the Assessment of Positive Symptoms and Scale for the Assessment of Negative Symptoms, were regressed on neighbourhood-level predictors, including population density, income deprivation, income inequality, social fragmentation, social cohesion, ethnic density and ethnic fragmentation, using multilevel regression. While age, gender and socioeconomic status were included as individual-level covariates, data on participant ethnicity were not available.

Results

Higher income inequality was associated with lower negative symptom scores (coefficient=–1.66, 95% CI –2.86 to –0.46, p

Conclusions

These findings provide further evidence that particular characteristics of the environment may be linked to specific symptom clusters in psychosis. Longitudinal studies are required to begin to tease apart the underlying mechanisms involved as well as the causal direction of such associations.

Prevalence of self-reported knee symptoms and management strategies among elderly individuals from Frederiksberg municipality: protocol for a prospective and pragmatic Danish cohort study

Por: Ginnerup-Nielsen · E. M. · Henriksen · M. · Christensen · R. · Heitmann · B. L. · Altman · R. · March · L. · Woolf · A. · Karlsen · H. · Bliddal · H.
Introduction

The Global Burden of Disease 2010 study ranked osteoarthritis (OA) as a leading cause of years lived with disability. With an ageing population, increasing body weight and sedentary lifestyle, a substantial increase especially in knee OA (KOA) is expected. Management strategies for KOA include non-pharmacological, pharmacological and surgical interventions. Meanwhile, over-the-counter pain medications have been discredited as they are associated with several risks with long-term usage. By consequence, the use of exercise and all sorts of complementary and alternative medicine (CAM) for joint pain has increased. The available self-management strategies are plenty, but there is no overview of their use at a population level and whether they are used along with doctors’ prescriptions or replace these. The aim of this study is to estimate the population incidence of developing knee symptoms and analyse the association between (and impact of) the use of self-reported preventive measures and knee symptoms.

Methods and analysis

This prospective cohort study pragmatically recruits individuals from the municipality of Frederiksberg, Denmark. All citizens aged 60–69 years old will be contacted annually for 10 years and asked to participate in a web-based survey. The major outcomes are self-reported knee symptoms and their association with use of various management strategies, including use of non-pharmacological treatments and CAM. Secondary outcomes include the influence of treatments on use of healthcare system and surgical procedures. Descriptive and analytic statistics (eg, logistic regression) will be used to provide summaries about the sample and observations made and the associations between self-management and development of knee symptoms.

Ethics and dissemination

This study can be implemented without permission from the Health Research Ethics Committee. Permission has been obtained from the Danish Data Protection Agency. Study findings will be disseminated in peer-reviewed journals and presented at relevant conferences.

Trial registration number

NCT03472300.

Optimising neonatal service provision for preterm babies born between 27 and 31 weeks gestation in England (OPTI-PREM), using national data, qualitative research and economic analysis: a study protocol

Por: Pillay · T. · Modi · N. · Rivero-Arias · O. · Manktelow · B. · Seaton · S. E. · Armstrong · N. · Draper · E. S. · Dawson · K. · Paton · A. · Ismail · A. Q. T. · Yang · M. · Boyle · E. M.
Introduction

In England, for babies born at 23–26 weeks gestation, care in a neonatal intensive care unit (NICU) as opposed to a local neonatal unit (LNU) improves survival to discharge. This evidence is shaping neonatal health services. In contrast, there is no evidence to guide location of care for the next most vulnerable group (born at 27–31 weeks gestation) whose care is currently spread between 45 NICU and 84 LNU in England. This group represents 12% of preterm births in England and over onr-third of all neonatal unit care days. Compared with those born at 23–26 weeks gestation, they account for four times more admissions and twice as many National Health Service bed days/year.

Methods

In this mixed-methods study, our primary objective is to assess, for babies born at 27–31 weeks gestation and admitted to a neonatal unit in England, whether care in an NICU vs an LNU impacts on survival and key morbidities (up to age 1 year), at each gestational age in weeks. Routinely recorded data extracted from real-time, point-of-care patient management systems held in the National Neonatal Research Database, Hospital Episode Statistics and Office for National Statistics, for January 2014 to December 2018, will be analysed. Secondary objectives are to assess (1) whether differences in care provided, rather than a focus on LNU/NICU designation, drives gestation-specific outcomes, (2) where care is most cost-effective and (3) what parents’ and clinicians' perspectives are on place of care, and how these could guide clinical decision-making. Our findings will be used to develop recommendations, in collaboration with national bodies, to inform clinical practice, commissioning and policy-making. The project is supported by a parent advisory panel and a study steering committee.

Ethics and dissemination

Research ethics approval has been obtained (IRAS 212304). Dissemination will be through publication of findings and development of recommendations for care.

Trial registration number

NCT02994849 and ISRCTN74230187.

Qualitative study exploring the key determinants of information gathering to inform the management of over-the-counter (OTC) consultations in community pharmacies

Por: Cassie · H. · Duncan · E. M. · Gibb · E. A. · Power · A. · Young · L. · Newlands · R. · Watson · M. C.
Objectives

Gathering relevant patient information during over-the-counter (OTC) consultations increases the likelihood of safe, effective and person-centred outcomes. The aim of this study was to explore the key determinants to information gathering during consultations for non-prescription medicine requests in community pharmacies in Scotland.

Design

Semi-structured interviews using the Theoretical Domains Framework (TDF), with community pharmacy teams across Scotland. Interviews explored participants’ knowledge of current guidance, skills required to elicit information and barriers and facilitators associated with this behaviour. Theory-based content analysis was undertaken using the TDF as an initial coding framework to identify key determinants and map them to salient domains. Salience was determined by prominence or variation in views. Comparative analysis was undertaken by professional role.

Results

Thirty interviews were conducted with pharmacists (n=19) and medicine counter assistants (MCAs) (n=11). Eight salient domains were identified: environmental context and resources (privacy), beliefs about consequences (patient safety), skills (communication, decision-making), social influences (patient awareness of pharmacist role), knowledge (awareness and use of standard operating procedures), social professional role and identity (perception of own role), behavioural regulation (training) and intention (to gather information). Similar domains were salient for pharmacists and MCAs; however, different beliefs were associated with different roles. Overarching themes were identified: best practice, health literacy, decision-making and professionalism.

Conclusions

Multiple influences and complexities affect the effective management of OTC consultations. While similar factors impact on both pharmacists and MCAs at a patient, professional and environmental level, subtle differences exist in how these influence their management of OTC consultations. This study highlights the importance of tailoring interventions to reflect different roles, functions and responsibilities of community pharmacy personnel.

Investigating the effect of a symposium on sexual health care in prostate cancer among Dutch healthcare professionals

Abstract

Aims and objectives

To investigate whether a symposium aimed at healthcare professionals in the uro‐oncological field changes knowledge, competence and general practice regarding sexual dysfunction after prostate cancer treatment.

Background

Sexual dysfunction is not frequently discussed by healthcare professionals; lack of knowledge and training are two of the most often reported barriers. Provision of additional training could improve knowledge, competence and general practice of healthcare professionals.

Design

Two questionnaires were used in this pre–post study to determine knowledge, competence and general practice at the time of the symposium and six months afterwards.

Methods

In order to perform repeated measures to analyse alterations among participating healthcare professionals (n = 55), the McNemar's test was used. A STROBE checklist was completed.

Results

Seventy‐three per cent (n = 40) stated that not enough attention was paid to prostate cancer‐related sexual dysfunction during their education. Nurses felt significantly less competent in discussing sexual function, advising on sexual dysfunction and actively inquiring sexual complaints compared to other healthcare professionals. After the symposium, sexual dysfunction was significantly more often discussed. No significant effects were found on knowledge on sexual dysfunction, knowledge on treatment of sexual dysfunction, competence in discussing sexual function, advising on sexual dysfunction, actively inquiring sexual complaints and rate of referral. Tools needed to address sexual dysfunction concerned written information materials (75.5%) and a website containing adequate information (56.6%).

Conclusions

The symposium had no significant influence on knowledge, competence and rate of referral in men with sexual dysfunction after prostate cancer treatment. However, sexual dysfunction was more frequently discussed after the symposium, so increase of awareness of consequences of prostate cancer treatment was achieved.

Relevance to clinical practice

Consequences of prostate cancer treatment to sexual function should be taken in consideration in daily practice; written information materials and a website containing adequate information were indicated as valuable resources to address sexual dysfunction in routine consultations.

Technology‐assisted nursing for postpartum support: A randomized controlled trial 产后支持的技术辅助护理:一项随机对照试验

Abstract

Aim

To determine if an electronic nursing intervention during the first 6 months postpartum was effective in improving mood and decreasing stress.

Background

Unmet needs postpartum can have a negative impact on mood and parenting stress. Technology‐assisted nursing care may provide needed support and reduce risk.

Design

Randomized controlled trial (RCT) with three conditions.

Methods

Enrollment began on 11 May 2017. Participants were randomized into one of three groups after completion of the baseline survey. Intervention I participants received standardized electronic messages four times/week for 6 months postpartum. Intervention II participants additionally received the option for nurse contact. Depression and parenting stress as measured using the Edinburgh Postnatal Depression Scale (EPDS) and Parenting Stress Index‐Short form (PSI‐SF) was obtained at 3 weeks, 3 months and 6 months postpartum and results compared with a usual care group. Patient satisfaction and nursing factors were measured.

Results

Significantly higher satisfaction scores were found in both intervention groups as compared with control, but there were no significant changes in EPDS or PSI‐SF.

Conclusion

The interventions were perceived as helpful and not burdensome. Better nurse‐sensitive outcome measures are needed to adequately assess effectiveness.

Impact

Postpartum women report unmet needs for support and education. The interventions were perceived as being helpful but did not significantly reduce depressive symptoms or parenting stress. Nurses can use this research to inform development of innovative approaches to support postpartum women.

Trial registration number

ClinicalTrials.gov NCT 02843022.

目的

探讨产后6个月的电子护理措施对改善情绪、减轻压力是否有效。

背景

未满足的产后需求会对情绪和育儿压力产生负面影响。技术辅助护理可以提供必要的帮助并降低风险。

设计

三种情况下的随机对照试验(RCT)。

方法

2017年5月11日开始招收受试人员。在完成基线调查后,将参与者随机分为三组。干预I组参与者在产后6个月内每周收到4次标准化电子信息。干预II组参与者还可以选择与护士接触。使用爱丁堡产后抑郁量表(EPDS)和育儿压力指数简表(PSI‐SF)测量产后3周、3个月和6个月的抑郁和育儿压力,并与普通护理组进行比较。测量患者满意度和护理因素。

结果

与对照组相比,两个干预组中满意度评分均显著高于对照组,但EPDS和PSI‐SF无明显变化。

结论

干预措施有助于减轻患者的负担。需要更好的护士敏感结果充分测量来评估疗效。

影响

产后妇女报告未满足的援助和教育需求。这些干预措施是有帮助的,但没有显著降低抑郁症状或育儿压力。护士可以利用这项研究来指导发展创新方法,以帮助产后妇女。

试验注册号

ClinicalTrials.gov NCT 02843022。

Low-dose aspirin as a promising agent for the prevention of spontaneous preterm birth

Commentary on: Andrikopoulou M, Purisch SE, Handal-Orefice R, et al. Low-dose aspirin is associated with reduced spontaneous preterm birth in nulliparous women. Am J Obstet Gynecol. 2018;219:399.e1–399.e6.

Implications for practice and research

  • At this moment, there is insufficient evidence to implement low-dose aspirin for the prevention of spontaneous preterm birth.

  • Placebo-controlled randomised controlled trials are needed to confirm the effectiveness of aspirin for the prevention of spontaneous preterm birth.

  • Context

    Preterm birth is the most important cause of perinatal morbidity and mortality worldwide. Despite the administration of progesterone to women with a previous spontaneous preterm birth, ~20%–30% will deliver preterm again.1 Accumulating evidence suggests that uteroplacental ischaemia plays an important role in the aetiology of spontaneous preterm birth, comparable to its role in preeclampsia. As aspirin is proven to reduce the risk of developing preeclampsia, it is hypothesised that aspirin might also be...

    Standard reference values of the postural control in healthy young female adults in Germany: an observational study

    Por: Ohlendorf · D. · Doerry · C. · Fisch · V. · Schamberger · S. · Erbe · C. · Wanke · E. M. · Groneberg · D. A.
    Objective

    Many people of all ages suffer from vertigo due to different reasons. The comparison of patient data with standard values can highlight deteriorations or changes in postural control and thus indicate, for example, an increased risk of falling. Our aim is to measure standard values for the postural control of young healthy women.

    Design

    Observational study.

    Setting

    Institute of Occupational Medicine, Social Medicine and Environmental Medicine, Goethe-University Frankfurt/Main.

    Participants

    106 healthy German female subjects aged between 21 and 30 years (25±2.7 years) were measured. Their average body mass index (BMI) was 21.1±2.61 kg/m².

    Outcome measures

    A pressure measuring platform was used to measure the weight distribution and postural sway in habitual standing. Median, tolerance range and CI were calculated.

    Results

    Height, weight and BMI are comparable to the average young German female population. The load distribution between right and left foot was 49.91%:50.09%. The forefoot was less loaded than the rear foot (33.3%:66.67%). The right rear foot carried most of the body weight (34.34%). The average body sway was 9.50 mm in the frontal and 13.00 mm in the sagittal plane.

    Conclusions

    Standard values for the postural control of the women aged 21–30 years correlate with the already collected data of healthy subjects and can therefore be described as representative. The standard values enable diagnosing and treating impaired balance.

    Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: protocol for a multicentre, randomised, placebo-controlled study

    Por: Hendricks · O. · Andersen · T. E. · Christiansen · A. A. · Primdahl · J. · Hauge · E. M. · Ellingsen · T. · Horsted · T. I. · Bachmann · A. G. · Loft · A. G. · Bojesen · A. B. · Ostergaard · M. · Lund Hetland · M. · Krogh · N. S. · Roessler · K. K. · Petersen · K. H.
    Introduction

    Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity.

    Methods and analysis

    A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan.

    Ethics and dissemination

    The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.

    Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

    Por: Gudbergsen · H. · Henriksen · M. · Waehrens · E. E. · Overgaard · A. · Bliddal · H. · Christensen · R. · Boesen · M. P. · Knop · F. K. K. · Astrup · A. · Rasmussen · M. U. · Bartholdy · C. · Daugaard · C. · Bartels · E. M. · Ellegaard · K. · Heitmann · B. L. · Kristensen · L. E.
    Introduction

    With an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.

    Methods and analysis

    150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week –8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.

    Ethics and dissemination

    The trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.

    Trial registration numbers

    2015-005163-16, NCT02905864, U1111-1171-4970

    Based on protocol version

    V.6; 30 January 2017, 15:30 hours

    Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: protocol of a multicentre randomised trial

    Por: Browne · P. D. · den Hollander · B. · Speksnijder · E. M. · van Wering · H. M. · Tjon a Ten · W. · George · E. K. · Groeneweg · M. · Bevers · N. · Wessels · M. M. S. · van den Berg · M. M. · Goede · J. · Teklenburg-Roord · S. T. A. · Frankenhuis · C. · Benninga · M. A. · Vlieger · A
    Introduction

    The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea.

    Methods and analysis

    To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8–18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months’ follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months’ follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea.

    Ethics and dissemination

    Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands.

    Trial registration number

    NTR5814.

    Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans

    Por: Mathersul · D. C. · Tang · J. S. · Schulz-Heik · R. J. · Avery · T. J. · Seppälä · E. M. · Bayley · P. J.
    Introduction

    Post-traumatic stress disorder (PTSD) is a debilitating, highly prevalent condition. Current clinical practice guidelines recommend trauma-focused psychotherapy (eg, cognitive processing therapy; CPT) as the first-line treatment for PTSD. However, while these treatments show clinically meaningful symptom improvement, the majority of those who begin treatment retain a diagnosis of PTSD post-treatment. Perhaps for this reason, many individuals with PTSD have sought more holistic, mind–body, complementary and integrative health (CIH) interventions. However, there remains a paucity of high-quality, active controlled efficacy studies of CIH interventions for PTSD, which precludes their formal recommendation.

    Methods and analyses

    We present the protocol for an ongoing non-inferiority parallel group randomised controlled trial (RCT) comparing the efficacy of a breathing meditation intervention (Sudarshan Kriya Yoga [SKY]) to a recommended evidence-based psychotherapy (CPT) for PTSD among veterans. Assessors are blinded to treatment group. The primary outcome measure is the PTSD Checklist-Civilian Version and a combination of clinical, self-report, experimental and physiological outcome measures assess treatment-related changes across each of the four PTSD symptom clusters (re-experiencing, avoidance, negative cognitions or mood and hyperarousal/reactivity). Once the RCT is completed, analyses will use both an intent-to-treat (using the ‘last observation carried forward’ for missing data) and a per-protocol or ‘treatment completers’ procedure, which is the most rigorous approach to non-inferiority designs.

    Ethics and dissemination

    To the best of our knowledge, this is this first non-inferiority RCT of SKY versus CPT for PTSD among veterans. The protocol is approved by the Stanford University Institutional Review Board. All participants provided written informed consent prior to participation. Results from this RCT will inform future studies including larger multi-site efficacy RCTs of SKY for PTSD and other mental health conditions, as well as exploration of cost-effectiveness and evaluation of implementation issues. Results will also inform evidence-based formal recommendations regarding CIH interventions for PTSD.

    Trial registration number

    NCT02366403; Pre-results.

    eHealth-based intervention to increase physical activity levels in people with cancer: protocol of a feasibility trial in an Irish acute hospital setting

    Por: Haberlin · C. · Broderick · J. · Guinan · E. M. · Darker · C. · Hussey · J. · ODonnell · D. M.
    Introduction

    Exercise and physical activity (PA) are established and effective treatment options for various side effects of cancer treatments such as surgery, chemotherapy and radiotherapy. The advent of eHealth brings new opportunities to influence healthy behaviours, using interactive and novel approaches. Influencing PA behaviours in people with cancer presents a potential application of this. The aim of this study is to evaluate the feasibility and preliminary efficacy of an intervention, using eHealth, for increasing PA in cancer survivors.

    Methods and analysis

    This will be a single-arm pre–post feasibility study. We aim to recruit a heterogeneous sample of 60 participants from cancer clinics in St. James’s Hospital, Dublin, Ireland. Eligibility criteria will include patients who have completed chemotherapy and/or radiotherapy with curative intent between 3 and 36 months prior to enrolment. The intervention will include the delivery of a 12-week PA programme. The eHealth aspect of the intervention will involve the provision of a Fitbit activity tracker, which will be used in conjunction with specific PA goals remotely prescribed and monitored by a physiotherapist. Primary outcomes will be feasibility measures related to the study (recruitment capability, data collection procedures, adherence and compliance, evaluation of the resources to implement the study and evaluation of participant responses to the intervention). Secondary measures will evaluate preliminary efficacy of the intervention in terms of clinical outcomes (body composition, PA (objective and self-report), quality of life and aerobic capacity). Primary and secondary outcomes will be assessed at baseline (as appropriate), at conclusion of the intervention and at a 6-month follow-up.

    Ethics and dissemination

    Ethical approval has been granted by the St. James’s Hospital/AMNCH Joint Ethics Committee (2016/05/02). Results from this study will be submitted for publication in peer-reviewed journals, as well as for presentation and dissemination at conferences in the field of oncology and survivorship.

    Trial registration

    NCT03036436; Pre-results.

    HeART of Stroke: randomised controlled, parallel-arm, feasibility study of a community-based arts and health intervention plus usual care compared with usual care to increase psychological well-being in people following a stroke

    Por: Ellis-Hill · C. · Thomas · S. · Gracey · F. · Lamont-Robinson · C. · Cant · R. · Marques · E. M. R. · Thomas · P. W. · Grant · M. · Nunn · S. · Paling · T. · Thomas · C. · Werson · A. · Galvin · K. T. · Reynolds · F. · Jenkinson · D.
    Introduction

    People often experience distress following stroke due to fundamental challenges to their identity.

    Objectives

    To evaluate (1) the acceptability of ‘HeART of Stroke’ (HoS), a community-based arts and health group intervention, to increase psychological well-being; and (2) the feasibility of a definitive randomised controlled trial (RCT).

    Design

    Two-centre, 24-month, parallel-arm RCT with qualitative and economic components. Randomisation was stratified by centre and stroke severity. Participant blinding was not possible. Outcome assessment blinding was attempted.

    Setting

    Community.

    Participants

    Community-dwelling adults ≤2 years poststroke recruited via hospital clinical teams/databases or community stroke/rehabilitation teams.

    Interventions

    Artist-facilitated arts and health group intervention (HoS) (ten 2-hour sessions over 14 weeks) plus usual care (UC) versus UC.

    Outcomes

    The outcomes were self-reported measures of well-being, mood, capability, health-related quality of life, self-esteem and self-concept (baseline and 5 months postrandomisation). Key feasibility parameters were gathered, data collection methods were piloted, and participant interviews (n=24) explored the acceptability of the intervention and study processes.

    Results

    Despite a low recruitment rate (14%; 95% CI 11% to 18%), 88% of the recruitment target was met, with 29 participants randomised to HoS and 27 to UC (57% male; mean (SD) age=70 (12.1) years; time since stroke=9 (6.1) months). Follow-up data were available for 47 of 56 (84%; 95% CI 72% to 91%). Completion rates for a study-specific resource use questionnaire were 79% and 68% (National Health Service and societal perspectives). Five people declined HoS postrandomisation; of the remaining 24 who attended, 83% attended ≥6 sessions. Preliminary effect sizes for candidate primary outcomes were in the direction of benefit for the HoS arm. Participants found study processes acceptable. The intervention cost an estimated £456 per person and was well-received (no intervention-related serious adverse events were reported).

    Conclusions

    Findings from this first community-based study of an arts and health intervention for people poststroke suggest a definitive RCT is feasible. Recruitment methods will be revised.

    Trial registration number

    ISRCTN99728983.

    Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial

    Por: Ryan · E. G. · Harrison · E. M. · Pearse · R. M. · Gates · S.
    Objective

    The traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.

    Design, setting, participants and interventions

    The OPTIMISE trial was a pragmatic, multicentre, observer-blinded, randomised controlled trial of 734 high-risk patients undergoing major gastrointestinal surgery in 17 acute care hospitals in the UK. Patients were randomly allocated to a cardiac output-guided haemodynamic therapy algorithm for intravenous fluid and inotropic drug administration during and in the 6 hours following surgery (n=368) or to standard care (n=366). The primary outcome was a binary outcome consisting of a composite of predefined 30-day moderate or major complications and mortality.

    Methods

    We repeated the primary outcome analysis of the OPTIMISE trial using Bayesian statistical methods to calculate the probability that the intervention was superior, and the probability that a clinically relevant difference existed. We explored the impact of a flat prior and an evidence-based prior on our analyses.

    Results

    Although OPTIMISE was not powered to detect a statistically significant difference between the treatment arms for the observed effect size (relative risk=0.84, 95% CI 0.70 to 1.01; p=0.07), by using Bayesian analyses we were able to demonstrate that there was a 96.9% (flat prior) to 99.5% (evidence-based prior) probability that the intervention was superior to the control.

    Conclusions

    The use of a Bayesian analytical approach provided a different interpretation of the findings of the OPTIMISE trial (compared with the original frequentist analysis), and suggested patient benefit from the intervention. Incorporation of information from previous studies provided further evidence of a benefit from the intervention. Bayesian analyses can produce results that are more easily interpretable and relevant to clinicians and policy-makers.

    Trial registration number

    ISRCTN04386758; Post-results.

    Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication: the ELECT Registry

    Por: van den Houten · M. M. · Jansen · S. C. · Sinnige · A. · van der Laan · L. · Vriens · P. W. · Willigendael · E. M. · Lardenoije · J.-W. H. · Elshof · J.-W. M. · van Hattum · E. S. · Lijkwan · M. A. · Nyklicek · I. · Rouwet · E. V. · Koelemay · M. J. · Scheltinga · M. R. · Teijink
    Introduction

    Despite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the Effect of Disease Level on Outcomes of Supervised Exercise in Intermittent Claudication Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease.

    Methods and analysis

    This multicentre prospective cohort study aims to enrol 320 patients in 10 vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1–3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularisation in case of insufficient effect (at the discretion of patient and vascular surgeon). For the primary objectives, patients are grouped according to anatomical characteristics of disease (aortoiliac, femoropopliteal or multilevel disease) as apparent on the preferred imaging modality in the participating centre (either duplex, CT angiography or magnetic resonance angiography). Changes in walking performance (treadmill tests, 6 min walk test) and quality of life (QoL; Vascular QoL Questionnaire-6, WHO QoL Questionnaire-Bref) will be compared between groups, after multivariate adjustment for possible confounders. Freedom from revascularisation and major adverse cardiovascular disease events, and attainment of the treatment goal between anatomical groups will be compared using Kaplan-Meier survival curves.

    Ethics and dissemination

    This study has been exempted from formal medical ethical approval by the Medical Research Ethics Committees United ‘MEC-U’ (W17.071). Results are intended for publication in peer-reviewed journals and for presentation to stakeholders nationally and internationally.

    Trial registration number

    NTR7332; Pre-results.

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