HRB Open Research

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EISSN : 25154826
Current Publisher: F1000 Research, Ltd. (10.12688)
Total articles ≅ 97
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Published: 17 February 2020
HRB Open Research; doi:10.12688/hrbopenres

Ladislav Timulak, Daragh Keogh, James McElvaney, Sonja Schmitt, Natalie Hession, Katarina Timulakova, Ciaran Jennings, Fiona Ward
Published: 13 February 2020
HRB Open Research, Volume 3; doi:10.12688/hrbopenres.12993.1

Abstract:Background: Depression, anxiety and related disorders, including obsessive-compulsive disorders and trauma/stressor related disorders, have high prevalence, chronic courses and cause significant impairment. These disorders are also highly co-morbid, and appear to share etiology and maintenance factors. Recent developments have seen the emergence of transdiagnostic approaches that systematically address the common/shared features of these disorders. A key advantage of transdiagnostic approaches is that they can reduce the pressure on mental health professionals to be proficient in a plethora of single-disorder focused treatments. Currently almost all transdiagnostic approaches come from cognitive-behavioural therapy (CBT). However, not all clients prefer or benefit from CBT. Emotion-focused therapy (EFT) represents an evidence-based alternative to CBT. This study aims to examine a transdiagnostic adaptation of EFT (EFT-T) as a treatment for depression, anxiety and related disorders. Method: The current study is a randomised controlled trial that aims to establish the efficacy of EFT-T vs. wait-list control in the treatment of depression, anxiety and related disorders. Up to 40 clients presenting in a psychology/counselling service will be randomly assigned to two conditions: EFT-T (n=20) and wait-list control, with delayed intervention (n=20). Primary outcome measures will be the Overall Anxiety Severity and Impairment Symptoms, the Overall Depression Severity and Impairment Symptoms, and the Clinical Outcome in Routine Evaluation – Outcome Measure. Disorder specific self-report measures will also be used to assess the main symptomatology of respective primary diagnoses. Clients will be assessed prior to therapy, at week 16, at end of therapy, and at 6 months follow-up. Discussion: This study aims to provide an initial test of EFT-T as a transdiagnostic treatment for depression, anxiety and related disorders. It will provide estimates of effects sizes that can inform power calculations for a comparative trial, comparing EFT-T to a standard transdiagnostic treatment, CBT. Registration: ISRCTN11430110; registered on 07 January 2019.
Lorna Roe, Miriam Galvin, Laura Booi, Lenisa Brandao, Jorge Leon Salas, Eimear McGlinchey, Dana Walrath
Published: 12 February 2020
HRB Open Research, Volume 3; doi:10.12688/hrbopenres.12990.1

Abstract:This Open Letter discusses the theme of ‘diversity in brain health’ in research, practice and policy for older LGBT+ people. It is written by a multidisciplinary group of Atlantic Fellows for Equity in Brain Health at the Global Brain Health Institute in Trinity College Dublin (TCD), from a variety of disciplines (health economics, human geography, anthropology, psychology, gerontology) and professions (researcher, clinicians, writers, practicing artists). The group developed a workshop to explore the theme of ‘Diversity and Brain Health’ through the lens of non-normative gender identities and sexualities. Guided by two advisors (Prof Agnes Higgins, TCD; Mr Ciaran McKinney, Age and Opportunity), we invited older LGBT+ people and those interested in the topic of LGBT+ and ageing, healthcare providers, policy makers and interested members of the research community. We partnered with colleagues in the School of Law to include socio-legal perspectives. Following the workshop, Roe and Walrath wrote an opinion editorial, published in the Irish Times during the 2019 PRIDE festival, and were subsequently invited by HRB Open Access to provide a more detailed expansion of that work. In this Open Letter we describe the theme of ‘diversity and brain health’ and some of the lessons we learned from listening to the lived experience of older LGBT+ people in Ireland today. We illustrate why it’s important to understand the lived experience of older LGBT+ people and highlight the failure of the State to evaluate the experience of LGBT+ people in policy implementation. We call on researchers, clinicians, service planners and policy makers, to recognize and address diversity as an important way to address health inequities in Ireland.
Niamh McGrath, Sheena McHugh, Patricia M. Kearney, Elaine Toomey
Published: 11 February 2020
HRB Open Research, Volume 2; doi:10.12688/hrbopenres.12947.2

Abstract:Background: Depression and diabetes distress are common in people with type 2 diabetes (T2DM). These conditions are independently associated with poorer T2DM outcomes and increased healthcare utilisation and costs. Questions remain regarding the most appropriate ways of initially detecting depression and diabetes distress in this group. Diabetes guidelines recommend depression screening in primary care for people with T2DM but their implementation in practice is suboptimal. As health care professionals influence detection practices, their perceptions and experiences of these guidelines can improve understanding of aspects of the guidelines that work, and those which are more difficult to implement in practice. This study describes the protocol for a qualitative evidence synthesis of primary care health professionals’ perceived barriers and enablers to screen for and diagnose depression and diabetes distress in people with T2DM. Methods and analysis: Primary qualitative studies will be identified using a systematic search of electronic databases and supplementary searching. We selected ‘best-fit framework synthesis’ as the approach to synthesise primary data using the RETREAT (Review question-Epistemology-Time/Timescale-Resources-Expertise-Audience and purpose-Type of Data) framework. Quality appraisal of primary studies and confidence in the overall review findings will be determined using the CASP (Critical Appraisal Skills Programme) and the GRADE-CERQual (Grading of Recommendations Assessment, Development, and Evaluation Confidence in the Evidence from Reviews of Qualitative research), respectively. Discussion: The planned review will provide the first, single point of reference of the available synthesised qualitative evidence on this topic. It will apply recommended approaches to ensure rigor and robustness of study and contribute meaningfully to understanding of how depression and diabetes distress can be initially detected in people with T2DM. This protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO) [registration number: CRD42019145483].
David Byrne, Tom Fahey, Frank Moriarty
Published: 10 February 2020
HRB Open Research, Volume 3; doi:10.12688/hrbopenres.12951.1

Abstract:Background: Sacubitril/valsartan is a first-in-class angiotensin-receptor neprilysin inhibitor used to treat heart failure with reduced ejection fraction. The evidence base for this novel medication is largely based on one pivotal phase III trial which was stopped early due to significant clinical benefits being shown. However potential limitations in the trial design have been highlighted in recent medical literature, necessitating a thorough review of the evidence base for sacubitril/valsartan. Methods: This review will be conducted using the PRISMA reporting guidelines. Relevant randomised controlled trials (RCTs) for sacubitril/valsartan will be systematically searched for in Medline (PubMed), Embase, Cochrane library, Google Scholar, Web of Science, Toxline and Scopus. Clinical trials registries will be searched, as will eight grey literature databases. In addition, unpublished clinical study reports (CSRs) of relevant trials will be requested from the European Medicines Agency (EMA) and the Clinical Study Data Request database. Studies will be included if they involve randomising adult patients with heart failure to either sacubitril/valsartan or usual care with either an active comparator or placebo as a control. All relevant clinical and safety outcomes will be reviewed, particularly hospitalisation due to heart failure and cardiovascular mortality. Two reviewers will assess eligibility of selected trials for inclusion. Data extraction will be performed separately for trial publications, clinical trial registries and for CSRs using a piloted form. Methodological quality of included trials from published sources will be assessed separately using the recently updated Cochrane Risk of Bias tool version 2. Narrative synthesis of included studies will be conducted and, if appropriate, meta-analysis for clinical efficacy and safety outcomes. Discussion: This review will collate all available RCT data on sacubitril/valsartan including published and unpublished sources in order to obtain a more complete picture of the evidence base for sacubitril/valsartan. Registration: This protocol has been submitted for registration on PROSPERO.
Peter May, Bridget M. Johnston, Charles Normand, Irene J. Higginson, Rose Anne Kenny, Karen Ryan
Published: 28 January 2020
HRB Open Research, Volume 2; doi:10.12688/hrbopenres.12975.2

Abstract:Background: All countries face growing demand for palliative care services. Projections of need are essential to plan care in an era of demographic change. We aim to estimate palliative care needs in the Republic of Ireland from 2016 to 2046. Methods: Static modelling of secondary data. First, we estimate the numbers of people who will die from a disease associated with palliative care need. We combine government statistics on cause of death (2007-2015) and projected mortality (2016-2046). Second, we combine these statistics with survey data to estimate numbers of people aged 50+ living and dying with diseases associated with palliative care need. Third, we use these projections and survey data to estimate disability burden, pain prevalence and health care utilisation among people aged 50+ living and dying with serious medical illness. Results: In 2016, the number of people dying annually from a disease indicating palliative care need was estimated as 22,806, and the number of people not in the last year of life aged 50+ with a relevant diagnosis was estimated as 290,185. Equivalent estimates for 2046 are up to 40,355 and 548,105, increases of 84% and 89% respectively. These groups account disproportionately for disability burden, pain prevalence and health care use among older people, meaning that population health burdens and health care use will increase significantly in the next three decades. Conclusion: The global population is ageing, although significant differences in intensity of ageing can be seen between countries. Prevalence of palliative care need will nearly double over 30 years, reflecting Ireland’s relatively young population. Older people living with a serious disease outnumber those in the last year of life by approximately 12:1, necessitating implementation of integrated palliative care across the disease trajectory. Urgent steps on funding, workforce development and service provision are required to address these challenges.
Christopher Dwyer, Robert A. Joyce, Eimear M. Bane, Anusha Moses, Alberto Alvarez-Iglesias, Sinéad M. Hynes
Published: 24 January 2020
HRB Open Research, Volume 3; doi:10.12688/hrbopenres.12981.1

Abstract:Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.
Emma Nicholson, Edel Doherty, Suja Somanadhan, Suzanne Guerin, James Schreiber, Gerard Bury, Thilo Kroll, Meredith Raley, Eilish McAuliffe
Published: 23 January 2020
HRB Open Research, Volume 3; doi:10.12688/hrbopenres.12973.1

Abstract:Background: Health inequities for children with intellectual disabilities (ID) are prevalent within different health systems, and children with ID have shorter life expectancies than the general population, higher mortality rates before the age of 17 and have a greater risk of potentially preventable hospitalisations. A health systems approach to research in this area provides a useful means through which research can inform policy and practice to ensure people with ID receive equitable healthcare; however, there is a paucity of evidence regarding how to address differences that have been described in the literature to date. The overall aim of this research is to establish the extent of health inequities for children with ID in Ireland compared to children without ID with respect to their utilisation of primary care and rates of hospitalisation, and to gain a better understanding of what influences utilisation of primary care and ED services in this population. Methods and analysis: The design of this research adopts a mixed-methods approach: statistical analysis of health data to determine the extent of health inequities in relation to healthcare utilisation; discrete choice experiments to explore General Practitioners’ decision making and parental preferences for optimal care; and concept mapping to develop consensus between stakeholders on how to address current healthcare inequities. Discussion: By applying a systems lens to the issue of health inequities for children with ID, the research hopes to gain a thorough understanding of the varying components that can contribute to the maintenance of such healthcare inequities. A key output from the research will be a set of feasible solutions and interventions that can address health inequities for this population.
Karen Kyne, Caroline McCarthy, Bridget Kiely, Susan M. Smith, Barbara Clyne, SPPiRE Study team
Published: 21 January 2020
HRB Open Research, Volume 2; doi:10.12688/hrbopenres.12920.2

Abstract:Background: Multimorbidity (the presence of two or more chronic conditions) is associated with poorer health outcomes, particularly for patients with significant polypharmacy (≥15 medications), due to the higher risk of adverse events and drug interactions. The SPPiRE study will assess the effectiveness of a complex intervention to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and significant polypharmacy. The aim of the SPPiRE process evaluation is to understand how and why the intervention is effective or ineffective and to explore the potential for system wide implementation of the intervention using the Medical Research Council general themes of context, implementation and mechanism of impact. Methods: The SPPiRE study is a clustered randomised controlled trial (RCT), aiming to recruit 55 general practices and 400 patients (≥65 years) on ≥15 medications throughout the Republic of Ireland. This mixed-methods process evaluation of the SPPiRE study will integrate both quantitative and qualitative data. Quantitative data will be collected on use of the intervention elements and from GP questionnaires. Qualitative data will be collected from semi-structured telephone interviews with all intervention GPs and a purposeful sample of patients from intervention practices. The topic guide will explore barriers and facilitators to participation and implementation of the intervention. Quantitative data will be analysed using descriptive statistics. Interviews will be transcribed and analysed using thematic analysis. Quantitative and qualitative data will be then be integrated. Discussion: The SPPiRE cluster RCT will provide evidence regarding the effectiveness and practicability of delivering a structured medication review in reducing polypharmacy and potentially inappropriate prescribing for patients with multimorbidity. This process evaluation will provide information on how the intervention was implemented, how it was or was not effective and the potential for a system wide implementation. Trial registration: ISRCTN 12752680, registration: 20/10/2016
Vicki Slater, Jennie Rose, Ellinor K. Olander, Karen Matvienko-Sikar, Sarah Redsell
Published: 16 January 2020
HRB Open Research, Volume 3; doi:10.12688/hrbopenres.12980.1

Abstract:Background: Childhood overweight and obesity is a major public health issue. Responsive feeding has been identified as having a protective effect against child overweight and obesity, and is associated with healthy weight gain during infancy. Responsive feeding occurs when the caregiver recognises and responds in a timely and developmentally appropriate manner to infant hunger and satiety cues. Despite its benefits, responsive feeding is not ubiquitous. To better support caregivers to engage in responsive feeding behaviours, it is necessary to first systematically identify the barriers and enablers associated with this behaviour. This mixed-methods systematic review therefore aims to synthesise evidence on barriers and enablers to responsive feeding using the COM-B model of behavioural change. Methods: 7 electronic databases will be searched (Maternal and Infant Care, CINAHL, Cochrane, PubMed, Medline, PsycINFO, EMBASE). Studies examining factors associated with parental responsive and non-responsive feeding of infants and children ( Ethics and dissemination: Ethical approval is not required for this review as no primary data will be collected, and no identifying personal information will be present. The review will be disseminated in a peer reviewed journal. PROSPERO registration: CRD42019144570 (06/08/2019)