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1.  Effectiveness of a multifactorial intervention on preventing development of frailty in pre-frail older people: study protocol for a randomised controlled trial 
BMJ Open  2015;5(2):e007091.
Introduction
Frailty is a major concern due to its costly and widespread consequences, yet evidence of effective interventions to delay or reduce frailty is lacking. Our previous study found that a multifactorial intervention was feasible and effective in reducing frailty in older people who were already frail. Identifying and treating people in the pre-frail state may be an effective means to prevent or delay frailty. This study describes a randomised controlled trial that aims to evaluate the effectiveness of a multifactorial intervention on development of frailty in older people who are pre-frail.
Methods and analysis
A single centre randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. Two hundred and thirty people aged above 70 who meet the Cardiovascular Health Study frailty criteria for pre-frailty, reside in the community and are without severe cognitive impairment will be recruited. Participants will be randomised to receive a multifactorial intervention or usual care. The intervention group will receive a 12-month interdisciplinary intervention targeting identified characteristics of frailty and problems identified during geriatric assessment. Participants will be followed for a 12-month period. Primary outcome measures will be degree of frailty measured by the number of Cardiovascular Health Study frailty criteria present, and mobility measured with the Short Physical Performance Battery. Secondary outcomes will include measures of mobility, mood and use of health and community services.
Ethics and dissemination
The study was approved by the Northern Sydney Local Health District Health Research Ethics Committee (1207-213M). The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals.
Trial registration number
Australian New Zealand Clinical Trials Registry: ACTRN12613000043730.
doi:10.1136/bmjopen-2014-007091
PMCID: PMC4322196  PMID: 25667151
GERIATRIC MEDICINE; frail elderly; randomised trial
2.  Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial 
BMJ Open  2015;5(2):e007031.
Introduction
Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described.
Methods and analysis
This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ≥50 mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100 mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8 weeks after treatment.
Ethics and dissemination
Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences.
Trial registration number
This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250.
doi:10.1136/bmjopen-2014-007031
PMCID: PMC4322200  PMID: 25652804
COMPLEMENTARY MEDICINE; NEUROSURGERY; PAIN MANAGEMENT; REHABILITATION MEDICINE
3.  Ear for recovery: protocol for a prospective study on parent–child communication and psychological recovery after paediatric injury 
BMJ Open  2015;5(2):e007393.
Introduction
One in six children who have been admitted to hospital with an injury develop persistent stress symptoms that put their development at risk. Parents play a crucial role in children's psychological recovery, however, it is unknown how specific parenting behaviours can help or hinder. We aim to describe the nature and quantity of parent–child communication after a child has been injured, and to examine how these interactions are related to children's psychological recovery.
Methods and analysis
We are conducting a prospective observational study among children aged 3–16 years, who have been admitted to a tertiary children's hospital with a serious injury. Data collection involves a naturalistic observation of spontaneous, everyday parent–child communication at home, shortly after discharge, and an assessment of children's psychological recovery at 6 weeks and 3 months post-injury. Main analyses comprise descriptive statistics, cluster analysis and analyses of variance.
Ethics and dissemination
This study has been approved by the Human Research Ethics Committee of the Royal Children's Hospital Melbourne (33103) and Monash University Human Research Ethics Committee (CF13/2515—2013001322). We aim to disseminate the findings through international peer-reviewed journals, international conferences and social media. Participants will be sent a summary of the overall study findings.
doi:10.1136/bmjopen-2014-007393
PMCID: PMC4322211  PMID: 25652805
PAEDIATRICS; MENTAL HEALTH; SOCIAL MEDICINE
4.  Positive and negative behaviours in workplace relationships: a scoping review protocol 
BMJ Open  2015;5(2):e007685.
Introduction
Engaging in teamwork requires a clear understanding of positive and negative behaviours that act as facilitators and barriers to collegial workplace relationships. Identifying and correcting underlying barriers, while promoting facilitators, is fundamental to improving care delivery and, ultimately, clinical outcomes. Despite a considerable amount of literature in this area, there is a lack of clarity of the different behaviours as several parallel literatures address similar questions about antecedents, processes and outcomes. The purpose of this study is to synthesise the current state of literature reporting on behaviours in workplace relationships. Using a scoping review methodology, the following research question will be addressed: “What is known about positive and negative behaviours in workplace relationships?”
Methods and analysis
We will employ the methodological frameworks used by Arksey and O'Malley and Levac et al. The search strategy will include numerous electronic databases, grey literature sources and hand-searching of reference lists from 1990 to present with a limit to English language. Search strategies will be developed using controlled vocabulary and keyword terms related to various components of workplace relationships. Two reviewers will independently screen titles and abstracts for inclusion, followed by screening of the full text of potential articles to determine final inclusion. A descriptive numerical analysis will describe characteristics of included studies. A thematic analysis will provide an overview of the literature, including definitions, conceptual frameworks, antecedents, outcomes and interventions.
Dissemination
In reviewing a wide range of positive and negative behaviours, then integrating into a manageable, meaningful whole, this study is a critical step in helping policymakers, leaders and healthcare professionals effectively use what is known thus far. Knowledge translation activities will occur throughout the study with dissemination of findings to local, national, and international stakeholders, including a wide range of clinicians, leaders and administrators in all sectors.
doi:10.1136/bmjopen-2015-007685
PMCID: PMC4322213  PMID: 25652806
5.  Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial) 
BMJ Open  2015;5(2):e007257.
Introduction
Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3–4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload.
Methods and analysis
This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant.
Ethics and dissemination
Relevant ethical approvals have been received. CONSORT Statement recommendations will be used to guide preparation of any publication. Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care.
Trial registration number
Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000).
doi:10.1136/bmjopen-2014-007257
PMCID: PMC4322194  PMID: 25649214
6.  Effectiveness of knowledge translation tools addressing multiple high-burden chronic diseases affecting older adults: protocol for a systematic review alongside a realist review 
BMJ Open  2015;5(2):e007640.
Introduction
The burden of chronic disease is a global phenomenon, particularly among people aged 65 years and older. More than half of older adults have more than one chronic disease and their care is not optimal. Chronic disease management (CDM) tools have the potential to meet this challenge but they are primarily focused on a single disease, which fails to address the growing number of seniors with multiple chronic conditions.
Methods and analysis
We will conduct a systematic review alongside a realist review to identify effective CDM tools that integrate one or more high-burden chronic diseases affecting older adults and to better understand for whom, under what circumstances, how and why they produce their outcomes. We will search MEDLINE, EMBASE, CINAHL, AgeLine and the Cochrane Library for experimental, quasi-experimental, observational and qualitative studies in any language investigating CDM tools that facilitate optimal disease management in one or more high-burden chronic diseases affecting adults aged ≥65 years. Study selection will involve calibration of reviewers to ensure reliability of screening and duplicate assessment of articles. Data abstraction and risk of bias assessment will also be performed independently. Analysis will include descriptive summaries of study and appraisal characteristics, effectiveness of each CDM tool (meta-analysis if appropriate); and a realist programme theory will be developed and refined to explain the outcome patterns within the included studies.
Ethics and dissemination
Ethics approval is not required for this study. We anticipate that our findings, pertaining to gaps in care across high-burden chronic diseases affecting seniors and highlighting specific areas that may require more research, will be of interest to a wide range of knowledge users and stakeholders. We will publish and present our findings widely, and also plan more active dissemination strategies such as workshops with our key stakeholders.
Trial registration number
Our protocol is registered with PROSPERO (registration number CRD42014014489).
doi:10.1136/bmjopen-2015-007640
PMCID: PMC4322198  PMID: 25649215
GENERAL MEDICINE (see Internal Medicine); INTERNAL MEDICINE
7.  Protocol of a longitudinal cohort study on physical activity behaviour in physically disabled patients participating in a rehabilitation counselling programme: ReSpAct 
BMJ Open  2015;5(1):e007591.
Introduction
Stimulating physical activity behaviour in persons with a physical disability is important, especially after discharge from rehabilitation. A tailored counselling programme covering both the period of the rehabilitation treatment and the first months at home seems on the average effective. However, a considerable variation in response is observed in the sense that some patients show a relevant beneficial response while others show no or only a small response on physical activity behaviour. The Rehabilitation, Sports and Active lifestyle (ReSpAct) study aims to estimate the associations of patient and programme characteristics with patients’ physical activity behaviour after their participation in a tailored counselling programme.
Methods and analysis
A questionnaire-based nationwide longitudinal prospective cohort study is conducted. Participants are recruited from 18 rehabilitation centres and hospitals in The Netherlands. 2000 participants with a physical disability or chronic disease will be followed during and after their participation in a tailored counselling programme. Programme outcomes on physical activity behaviour and patient as well as programme characteristics that may be associated with differences in physical activity behaviour after programme completion are being assessed. Data collection takes place at baseline and 14, 33 and 52 weeks after discharge from rehabilitation.
Ethics and dissemination
The study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Groningen and at individual participating institutions. All participants give written informed consent. The study results will provide new insights into factors that may help explain the differences in physical activity behaviour of patients with a physical disability after they have participated in the same physical activity and sports stimulation programme. Thereby, it will support healthcare professionals to tailor their guidance and care to individual patients in order to stimulate physical activity after discharge in a more efficient and effective way.
Trial registration number
NTR3961.
doi:10.1136/bmjopen-2015-007591
PMCID: PMC4316554  PMID: 25633288
SPORTS MEDICINE; REHABILITATION MEDICINE; PREVENTIVE MEDICINE; PUBLIC HEALTH; COMPLEMENTARY MEDICINE
8.  Protocol for a human in vivo model of acute cigarette smoke inhalation challenge in smokers with COPD: monitoring the nasal and systemic immune response using a network biology approach 
BMJ Open  2015;5(1):e005750.
Introduction
Cigarette smoke contributes to a diverse range of diseases including chronic obstructive pulmonary disease (COPD), cardiovascular disorders and many cancers. There currently is a need for human challenge models, to assess the acute effects of a controlled cigarette smoke stimulus, followed by serial sampling of blood and respiratory tissue for advanced molecular profiling. We employ precision sampling of nasal mucosal lining fluid by absorption to permit soluble mediators measurement in eluates. Serial nasal curettage was used for transcriptomic analysis of mucosal tissue.
Methods and analysis
Three groups of strictly defined patients will be studied: 12 smokers with COPD (GOLD Stage 2) with emphysema, 12 matched smokers with normal lung function and no evidence of emphysema, and 12 matched never smokers with normal spirometry. Patients in the smoking groups are current smokers, and will be given full support to stop smoking immediately after this study. In giving a controlled cigarette smoke stimulus, all patients will have abstained from smoking for 12 h, and will smoke two cigarettes with expiration through the nose in a ventilated chamber. Before and after inhalation of cigarette smoke, a series of samples will be taken from the blood, nasal mucosal lining fluid and nasal tissue by curettage. Analysis of plasma nicotine and metabolites in relation to levels of soluble inflammatory mediators in nasal lining fluid and blood, as well as assessing nasal transcriptomics, ex vivo blood platelet aggregation and leucocyte responses to toll-like receptor agonists will be undertaken.
Implications
Development of acute cigarette smoke challenge models has promise for the study of molecular effects of smoking in a range of pathological processes.
Ethics and dissemination
This study was approved by the West London National Research Ethics Committee (12/LO/1101). The study findings will be presented at conferences and will be reported in peer-reviewed journals.
doi:10.1136/bmjopen-2014-005750
PMCID: PMC4316420  PMID: 25631307
9.  The POPPY Research Programme protocol: investigating opioid utilisation, costs and patterns of extramedical use in Australia 
BMJ Open  2015;5(1):e007030.
Introduction
Opioid prescribing is increasing in many countries. In Australia, there is limited research on patterns of prescribing and access, or the outcomes associated with this use. The aim of this research programme is to use national dispensing data to estimate opioid use and costs, including problematic or extramedical use in the Australian population.
Methods and analysis
In a cohort of persons dispensed at least one opioid in 2013, we will estimate monthly utilisation and costs of prescribed opioids, overall and according to individual opioid formulations and strengths. In a cohort of new opioid users, commencing therapy between 1 July 2009 and 31 December 2013, we will examine patterns of opioid use including initiation of therapy, duration of treatment and concomitant use of opioids and other prescribed medicines. We will also examine patterns of extramedical opioid use based on indicators including excess dosing, use of more than one opioid concomitantly, doctor/pharmacy shopping and accelerated time to prescription refill.
Ethics and dissemination
This protocol was approved by the NSW Population and Health Services Ethics Committee (March 2014) and data access approved by the Department of Human Services External Review Evaluation Committee (June 2014). This will be one of the first comprehensive Australian studies with the capability to investigate individual patterns of use and track extramedical use. In the first instance our analysis will be based on 5 years of dispensing data but will be expanded with ongoing annual data updates. This research has the capability to contribute significantly to pharmaceutical policy within Australia and globally. In particular, the trajectory of extramedical prescription-opioid use has been the subject of limited research to date. The results of this research will be published widely in general medical, pharmacoepidemiology, addiction and psychiatry journals.
doi:10.1136/bmjopen-2014-007030
PMCID: PMC4316424  PMID: 25631315
EPIDEMIOLOGY; PAIN MANAGEMENT; PUBLIC HEALTH
10.  A scoping review protocol to map the research foci trends in tobacco control over the last decade 
BMJ Open  2015;5(1):e006643.
Introduction
Tobacco dependence and smoke exposure have been global epidemics with health consequences recognised by the US Surgeon General since the 1960s and 1970s, respectively. During this period, a vast body of research evidence has emerged including many reviews of primary research studies targeting various tobacco control strategies. Published review studies synthesise primary evidence, providing a rich source for mapping the broad range of topics and research foci along with revealing areas of evidence deficits. In this paper, we outline our scoping review protocol to systematically review published review articles specific to tobacco control and primary prevention over the last 10 years.
Methods and analysis
Using Arksey and O'Malley's scoping review methodology as a guide, our scoping review of published reviews begins by searching several databases: PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and the Educational Resources Information Centre (ERIC). Our multidisciplinary team has formulated search strategies and two reviewers will independently screen eligible studies for final study selection. Bibliographic data and abstract content will be collected and analysed using a tool developed iteratively by the research team.
Ethics and dissemination
A scoping review of published review articles is a novel approach for examining the breadth of literature regarding tobacco control strategies and, as a secondary analysis, does not require ethics approval. We anticipate results will identify research gaps as well as novel ideas for primary prevention research specific to tobacco control strategies concerning intervention, programming and policy. Although this is our first step in establishing a foundation for a research agenda, we will be disseminating results through journals and conferences targeting primary care providers and tobacco control.
doi:10.1136/bmjopen-2014-006643
PMCID: PMC4316427  PMID: 25631312
PREVENTIVE MEDICINE; STATISTICS & RESEARCH METHODS; PRIMARY CARE; PUBLIC HEALTH
11.  Understanding the motivation and performance of community health volunteers involved in the delivery of health programmes in Kampala, Uganda: a realist evaluation protocol 
BMJ Open  2015;5(1):e006752.
Introduction
The recruitment of community health volunteers to support the delivery of health programmes is a well-established approach in many countries, particularly where health services are not readily available. However, studies on management of volunteers are scarce and current research on human resource management of volunteers faces methodological challenges. This paper presents the protocol of a realist evaluation that aims at identifying the factors influencing the performance of community health volunteers involved in the delivery of a Red Cross immunisation programme in Kampala (Uganda) with a specific focus on motivation.
Methods and analysis
The realist evaluation cycle structures the protocol. To develop the theoretical basis for the evaluation, the authors conducted interviews and reviewed the literature on community health volunteers’ performance, management and organisational behaviour. This led to the formulation of the initial programme theory, which links the intervention inputs (capacity-building strategies) to the expected outcomes (positive work behaviour) with mechanisms that point in the direction of drivers of motivation. The contextual elements include components such as organisational culture, resource availability, etc. A case study design will be adopted. We define a case as a Red Cross branch, run by a programme manager, and will select two cases at the district level in Kampala. Mixed methods will be used in data collection, including individual interviews of volunteers, participant observation and document review. The thematic analysis will be based on the initial programme theory and will seek for context-mechanism-outcome configurations. Findings from the two cases will be compared.
Discussion
We discuss the scope for applying realist evaluation and the methodological challenges we encountered in developing this protocol.
Ethics and dissemination
The study was approved by the Ethical Committee at Rennes University Hospital, France. Results will be published in scientific journals, and communicated to respondents and relevant institutions.
doi:10.1136/bmjopen-2014-006752
PMCID: PMC4316434  PMID: 25631314
PUBLIC HEALTH
12.  Evidence of and recommendations for non-pharmacological interventions for common geriatric conditions: the SENATOR-ONTOP systematic review protocol 
BMJ Open  2015;5(1):e007488.
Introduction
Non-pharmacological therapies for common chronic medical conditions in older patients are underused in clinical practice. We propose a protocol for the assessment of the evidence of non-pharmacological interventions to prevent or treat relevant outcomes in several prevalent geriatric conditions in order to provide recommendations.
Methods and analysis
The conditions of interest for which the evidence about efficacy of non-pharmacological interventions will be searched include delirium, falls, pressure sores, urinary incontinence, dementia, heart failure, orthostatic hypotension, sarcopaenia and stroke. For each condition, the following steps will be undertaken: (A) prioritising clinical questions; (B) retrieving the evidence (MEDLINE, the Cochrane Library, CINAHL and PsychINFO will be searched to identify systematic reviews); (C) assessing the methodological quality of the evidence (risk of bias according to the Cochrane method will be applied to the primary studies retrieved from the systematic reviews); (D) developing recommendations based on the evidence (Grading of Recommendations Assessment, Development and Evaluation (GRADE) items—risk of bias, imprecision, inconsistency, indirectness and publication bias—will be used to rate the overall evidence and develop recommendations).
Dissemination
For each target condition, at least one systematic overview concerning the evidence of non-pharmacological interventions will be produced and published in peer-reviewed journals.
doi:10.1136/bmjopen-2014-007488
PMCID: PMC4316555  PMID: 25628049
non-pharmacological interventions; systematic overview; GRADE method
13.  Real-time continuous glucose monitoring versus conventional glucose monitoring in critically ill patients: a systematic review study protocol 
BMJ Open  2015;5(1):e006579.
Introduction
Stress-induced hyperglycaemia, which has been shown to be associated with an unfavourable prognosis, is common among critically ill patients. Additionally, it has been reported that hypoglycaemia and high glucose variabilities are also associated with adverse outcomes. Thus, continuous glucose monitoring (CGM) may be the optimal method to detect severe hypoglycaemia, hyperglycaemia and decrease glucose excursion. However, the overall accuracy and reliability of CGM systems and the effects of CGM systems on glucose control and prognosis in critically ill patients remain inconclusive. Therefore, we will conduct a systematic review and meta-analysis to clarify the associations between CGM systems and clinical outcome.
Methods and analysis
We will search PubMed, EMBASE and the Cochrane Library from inception to October 2014. Studies comparing CGM systems with any other glucose monitoring methods in critically ill patients will be eligible for our meta-analysis. The primary endpoints include the incidence of hypoglycaemia and hyperglycaemia, mean glucose level, and percentage of time within the target range. The second endpoints include intensive care unit (ICU) mortality, hospital mortality, duration of mechanical ventilation, length of ICU and hospital stay, and the Pearson correlation coefficient and the results of error grid analysis. In addition, we will record all complications (eg, acquired infections) in control and intervention groups and local adverse events in intervention groups (eg, bleeding or infections).
Ethics and dissemination
Ethics approval is not required as this is a protocol for a systematic review. The findings will be disseminated in a peer-reviewed journal and presented at a relevant conference.
Trial registration number
PROSPERO registration number: CRD42014013488.
doi:10.1136/bmjopen-2014-006579
PMCID: PMC4305078  PMID: 25616512
glucose; continuous monitoring; hyperglycemia; hypoglycemia; mortality
14.  Body composition and bone health in long-term survivors of acute lymphoblastic leukaemia in childhood and adolescence: the protocol for a cross-sectional cohort study 
BMJ Open  2015;5(1):e006191.
Introduction
Success in the treatment of young people with cancer, as measured conventionally by survival rates, is mitigated by late effects of therapy that impose a burden of morbidity and limit life expectancy. Among these adverse sequelae are altered body composition, especially obesity, and compromised bone health in the form of osteoporosis and increased fragility. These outcomes are potentially reversible and even preventable. This study will examine measures of body composition and bone health in long-term survivors of acute lymphoblastic leukaemia (ALL) in childhood and adolescence. These measures will be complemented by measures of physical activity and health-related quality of life (HRQL).
Methods and analysis
Survivors of ALL who are at least 10 years from diagnosis, following treatment on uniform protocols, will undergo measurements of body mass index; triceps skin fold thickness and mid-upper arm circumference; fat mass, lean body mass, skeletal muscle mass and bone mineral density by dual energy X-ray absorptiometry; trabecular and cortical bone indices and muscle density by peripheral quantitative CT; physical activity by the Habitual Activity Estimation Scale; and HRQL by Health Utilities Index instruments. Descriptive measures will be used for continuous variables and number (percent) for categorical variables. Associations between variables will be assessed using Fisher's exact t test and the χ2 test; correlations will be tested by the Pearson correlation coefficient.
Ethics and dissemination
The study is approved by the institutional research ethics board and is supported by a competitive funding award. Dissemination of the results will occur by presentations to scientific meetings and publications in peer-reviewed journals, and by posting summaries of the results on websites accessed by adolescent and young adult survivors of cancer.
doi:10.1136/bmjopen-2014-006191
PMCID: PMC4305072  PMID: 25603918
15.  Clinical effects of blood donor characteristics in transfusion recipients: protocol of a framework to study the blood donor–recipient continuum 
BMJ Open  2015;5(1):e007412.
Introduction
When used appropriately, transfusion of red blood cells (RBCs) is a necessary life-saving therapy. However, RBC transfusions have been associated with negative outcomes such as infection and organ damage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource. This study will create a framework to analyse the influence of blood donor characteristics on recipient outcomes.
Methods and analysis
We will conduct a multisite, longitudinal cohort study using blood donor data routinely collected by Canadian Blood Services, and recipient data from health administrative databases. Our project will include a thorough validation of primary data, the linkage of various databases into one large longitudinal database, an in-depth epidemiological analysis and a careful interpretation and dissemination of the results to assist the decision-making process of clinicians, researchers and policymakers in transfusion medicine. Our primary donor characteristic will be age of blood donors and our secondary donor characteristics will be donor–recipient blood group compatibility and blood donor sex. Our primary recipient outcome will be a statistically appropriate survival analysis post-RBC transfusion up to a maximum of 8 years. Our secondary recipient outcomes will include 1-year, 2-year and 5-year mortality; hospital and intensive care unit length of stay; rehospitalisation; new cancer and cancer recurrence rate; infection rate; new occurrence of myocardial infarctions and need for haemodialysis.
Ethics and dissemination
Our results will help determine whether we need to tailor transfusion based on donor characteristics, and perhaps this will improve patient outcome. Our results will be customised to target the different stakeholders involved with blood transfusions and will include presentations, peer-reviewed publications and the use of the dissemination network of blood supply organisations. We obtained approval from the Research Ethics boards and privacy offices of all involved institutions.
doi:10.1136/bmjopen-2014-007412
PMCID: PMC4305074  PMID: 25600255
EPIDEMIOLOGY; HAEMATOLOGY
16.  Establishment of a prospective cohort of mechanically ventilated patients in five intensive care units in Lima, Peru: protocol and organisational characteristics of participating centres 
BMJ Open  2015;5(1):e005803.
Introduction
Mechanical ventilation is a cornerstone in the management of critically ill patients worldwide; however, less is known about the clinical management of mechanically ventilated patients in low and middle income countries where limitation of resources including equipment, staff and access to medical information may play an important role in defining patient-centred outcomes. We present the design of a prospective, longitudinal study of mechanically ventilated patients in Peru that aims to describe a large cohort of mechanically ventilated patients and identify practices that, if modified, could result in improved patient-centred outcomes and lower costs.
Methods and analysis
Five Peruvian intensive care units (ICUs) and the Medical ICU at the Johns Hopkins Hospital were selected for this study. Eligible patients were those who underwent at least 24 h of invasive mechanical ventilation within the first 48 h of admission into the ICU. Information on ventilator settings, clinical management and treatment were collected daily for up to 28 days or until the patient was discharged from the unit. Vital status was assessed at 90 days post enrolment. A subset of participants who survived until hospital discharge were asked to participate in an ancillary study to assess vital status, and physical and mental health at 6, 12, 24 and 60 months after hospitalisation, Primary outcomes include 90-day mortality, time on mechanical ventilation, hospital and ICU lengths of stay, and prevalence of acute respiratory distress syndrome. In subsequent analyses, we aim to identify interventions and standardised care strategies that can be tailored to resource-limited settings and that result in improved patient-centred outcomes and lower costs.
Ethics and dissemination
We obtained ethics approval from each of the four participating hospitals in Lima, Peru, and at the Johns Hopkins School of Medicine, Baltimore, USA. Results will be disseminated as several separate publications in different international journals.
doi:10.1136/bmjopen-2014-005803
PMCID: PMC4298097  PMID: 25596196
EPIDEMIOLOGY
17.  Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial 
BMJ Open  2015;5(1):e007247.
Introduction
Otitis media (OM) starts within weeks of birth in almost all Indigenous infants living in remote areas of the Northern Territory (NT). OM and associated hearing loss persist from infancy throughout childhood and often into adulthood. Educational and social opportunities are greatly compromised. Pneumococcus and non-typeable Haemophilus influenzae (NTHi) are major OM pathogens that densely colonise the nasopharynx and infect the middle ear from very early in life. Our hypothesis is that compared to current single vaccine schedules, a combination of vaccines starting at 1 month of age, may provide earlier, broadened protection.
Methods and analyses
This randomised outcome assessor, blinded controlled trial will recruit 425 infants between 28 and 38 days of age and randomly allocate them (1:1:1) to one of three pneumococcal conjugate vaccine (PCV) schedules: Synflorix at 2, 4, 6 months of age, Prevenar13 at 2, 4 and 6 months of age, or an investigational schedule of Synflorix at 1, 2 and 4 months plus Prevenar13 at 6 months of age. The blinded primary outcomes at 7 months of age are immunogenicity of specific vaccine antigens (geometric mean concentration (GMC) and proportion of participants with above threshold GMC of 0.35 µg/L). Secondary outcomes at all timepoints are additional immunogenicity measures and proportion of participants with nasopharyngeal carriage of vaccine-type pneumococci and NTHi, and any OM, including any tympanic membrane perforation. Parental interviews will provide data on common risk factors for OM.
Ethics and dissemination
Ethical approval has been obtained from NT Department of Health and Menzies HREC (EC00153), Central Australian HREC (EC00155) and West Australian Aboriginal Health Ethics Committee (WAAHEC- 377-12/2011). Final trial results, data analyses, interpretation and conclusions will be presented in appropriate written and oral formats to parents and guardians, participating communities, local, national and international conferences, and published in peer-reviewed open access journals.
Trial registration numbers
ACTRN12610000544077 and NCT01174849.
doi:10.1136/bmjopen-2014-007247
PMCID: PMC4298104  PMID: 25596202
IMMUNOLOGY; MICROBIOLOGY; PUBLIC HEALTH
18.  Low-dose dexamethasone as a treatment for women with heavy menstrual bleeding: protocol for response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM) 
BMJ Open  2015;5(1):e006837.
Introduction
Heavy menstrual bleeding (HMB) diminishes individual quality-of-life and poses substantial societal burden. In HMB endometrium, inactivation of cortisol (by enzyme 11β hydroxysteroid dehydrogenase type 2 (11βHSD2)), may cause local endometrial glucocorticoid deficiency and hence increased angiogenesis and impaired vasoconstriction. We propose that ‘rescue’ of luteal phase endometrial glucocorticoid deficiency could reduce menstrual bleeding.
Methods and analysis
DexFEM is a double-blind response-adaptive parallel-group placebo-controlled trial in women with HMB (108 to be randomised), with active treatment the potent oral synthetic glucocorticoid dexamethasone, which is relatively resistant to 11βHSD2 inactivation. Participants will be aged over 18 years, with mean measured menstrual blood loss (MBL) for two screening cycles ≥50 mL. The primary outcome is reduction in MBL from screening. Secondary end points are questionnaire assessments of treatment effect and acceptability. Treatment will be for 5 days in the mid-luteal phases of three treatment menstrual cycles. Six doses of low-dose dexamethasone (ranging from 0.2 to 0.9 mg twice daily) will be compared with placebo, to ascertain optimal dose, and whether this has advantage over placebo. Statistical efficiency is maximised by allowing randomisation probabilities to ‘adapt’ at five points during enrolment phase, based on the response data available so far, to favour doses expected to provide greatest additional information on the dose–response. Bayesian Normal Dynamic Linear Modelling, with baseline MBL included as covariate, will determine optimal dose (re reduction in MBL). Secondary end points will be analysed using generalised dynamic linear models. For each dose for all end points, a 95% credible interval will be calculated for effect versus placebo.
Ethics and dissemination
Dexamethasone is widely used and hence well-characterised safety-wise. Ethical approval has been obtained from Scotland A Research Ethics Committee (12/SS/0147). Trial findings will be disseminated via open-access peer-reviewed publications, conferences, clinical networks, public lectures, and our websites.
Trial registration number
ClinicalTrials.gov NCT01769820; EudractCT 2012-003405-98.
doi:10.1136/bmjopen-2014-006837
PMCID: PMC4298087  PMID: 25588784
STATISTICS & RESEARCH METHODS
19.  Efficacy of metformin in pregnant obese women: a randomised controlled trial 
BMJ Open  2015;5(1):e006854.
Introduction
Increasing evidence suggests obesity has its origins prior to birth. There is clear correlation between maternal obesity, high birthweight and offspring risk of obesity in later life. It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes, including gestational diabetes and stillbirth. The mechanism(s) by which obesity causes these problems is unknown, although hyperglycaemia and insulin resistance are strongly implicated. We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women, thereby reducing the incidence of high birthweight babies and other pregnancy complications.
Methods and analysis
The Efficacy of Metformin in Pregnant Obese Women, a Randomised controlled (EMPOWaR) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese (body mass index >30 kg/m2) pregnant women from 16 weeks’ gestation until delivery reduces the incidence of high birthweight babies. A secondary aim is to test the mechanism(s) of any effect. Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16 weeks’ gestation and prescribed study medication, metformin or placebo, to be taken until delivery. Further study visits will occur at 28 and 36 weeks’ gestation for glucose tolerance testing and to record anthropometric measurements. Birth weight and other measurements will be recorded at time of delivery. Anthropometry of mother and baby will be performed at 3 months postdelivery. As of January 2014, 449 women had been randomised across the UK.
Ethics and dissemination
The study will be conducted in accordance with the principles of Good Clinical Practice. A favourable ethical opinion was obtained from Scotland A Research Ethics Committee, reference number 10/MRE00/12. Results will be disseminated at conferences and published in peer-reviewed journals.
Trial registration number
ISRCTN51279843.
doi:10.1136/bmjopen-2014-006854
PMCID: PMC4298109  PMID: 25588785
20.  Identifying postoperative atrial fibrillation in cardiac surgical patients posthospital discharge, using iPhone ECG: a study protocol 
BMJ Open  2015;5(1):e006849.
Introduction
Postoperative atrial fibrillation (AF) occurs in 30–40% of patients after cardiac surgery. Identification of recurrent postoperative AF is required to initiate evidence-based management to reduce the risk of subsequent stroke. However, as AF is often asymptomatic, recurrences may not be detected after discharge. This study determines feasibility and impact of a self-surveillance programme to identify recurrence of postoperative AF in the month of posthospital discharge.
Methods and analysis
This is a feasibility study, using a cross-sectional study design, of self-screening for AF using a hand-held single-lead iPhone electrocardiograph device (iECG). Participants will be recruited from the cardiothoracic surgery wards of the Royal North Shore Hospital and North Shore Private Hospital, Sydney, Australia. Cardiac surgery patients admitted in sinus rhythm and experiencing a transient episode of postoperative AF will be eligible for recruitment. Participants will be taught to take daily ECG recordings for 1 month posthospital discharge using the iECG and will be provided education regarding AF, including symptoms and health risks. The primary outcome is the feasibility of patient self-monitoring for AF recurrence using an iECG. Secondary outcomes include proportion of patients identified with recurrent AF; estimation of stroke risk and patient knowledge. Process outcomes and qualitative data related to acceptability of patient's use of the iECG and sustainability of the screening programme beyond the trial setting will also be collected.
Ethics and dissemination
Primary ethics approval was received on 25 February 2014 from Northern Sydney Local Health District Human Resource Ethics Committee, and on 17 July 2014 from North Shore Private Hospital Ethics Committee. Results will be disseminated via forums including, but not limited to, peer-reviewed publications and presentation at national and international conferences.
Trial registration number
ACTRN12614000383662.
doi:10.1136/bmjopen-2014-006849
PMCID: PMC4298095  PMID: 25586373
postoperative; atrial fibrillation; screening; monitoring; electrocardiogram; prevention
21.  Protocol for a multicentre, prospective, population-based cohort study of variation in practice of cholecystectomy and surgical outcomes (The CholeS study) 
BMJ Open  2015;5(1):e006399.
Introduction
Cholecystectomy is one of the most common general surgical operations performed. Despite level one evidence supporting the role of cholecystectomy in the management of specific gallbladder diseases, practice varies between surgeons and hospitals. It is unknown whether these variations account for the differences in surgical outcomes seen in population-level retrospective data sets. This study aims to investigate surgical outcomes following acute, elective and delayed cholecystectomies in a multicentre, contemporary, prospective, population-based cohort.
Methods and analysis
UK and Irish hospitals performing cholecystectomies will be recruited utilising trainee-led research collaboratives. Two months of consecutive, adult patient data will be included. The primary outcome measure of all-cause 30-day readmission rate will be used in this study. Thirty-day complication rates, bile leak rate, common bile duct injury, conversion to open surgery, duration of surgery and length of stay will be measured as secondary outcomes. Prospective data on over 8000 procedures is anticipated. Individual hospitals will be surveyed to determine local policies and service provision. Variations in outcomes will be investigated using regression modelling to adjust for confounders.
Ethics and dissemination
Research ethics approval is not required for this study and has been confirmed by the online National Research Ethics Service (NRES) decision tool. This novel study will investigate how hospital-level surgical provision can affect patient outcomes, using a cross-sectional methodology. The results are essential to inform commissioning groups and implement changes within the National Health Service (NHS). Dissemination of the study protocol is primarily through the trainee-led research collaboratives and the Association of Upper Gastrointestinal Surgeons (AUGIS). Individual centres will have access to their own results and the collective results of the study will be published in peer-reviewed journals and presented at relevant surgical conferences.
doi:10.1136/bmjopen-2014-006399
PMCID: PMC4298090  PMID: 25582453
22.  [No title available] 
PMCID: PMC4289725  PMID: 25575875
23.  [No title available] 
PMCID: PMC4289716  PMID: 25573525
24.  [No title available] 
PMCID: PMC4289734  PMID: 25573527
25.  [No title available] 
PMCID: PMC4289726  PMID: 25567064

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