Harmonising the human biobanking consent process: an Irish experience

Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by the Participant Information Leaflets and Informed Consent Form (PI/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation and the related Irish Health Research Regulation presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, General Data Protection Regulation/Health Research Regulation-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network.

Management of psychotropic medications in adults with intellectual disability: a scoping review protocol

Introduction: Psychotropic medications are commonly prescribed among adults with intellectual disability (ID), often in the absence of a psychiatric diagnosis. As such, there is great disparity between the estimated prevalence of mental illness and the rates of psychotropic medication use amongst people with ID. ‘Off-label’ use of these medications may account for much of this discrepancy, in particular their use in the management of challenging behaviour. This has come under scrutiny due to the myriad of side effects and the deficiency of high-quality data supporting their use for this indication. Understanding the causes and justifications for such disparity is essential in discerning the efficacy of current prescription practice. Objective: To explore the existing evidence base regarding the prescription and management of psychotropic medications in adults with ID. The aim will be achieved through identifying the psychotropic medications commonly prescribed, the underlying rationale(s) for their prescription and the evidence available that demonstrates their appropriateness and effectiveness. Additionally, the paper will seek to evaluate the availability of any existing guidance that informs the management of these medications, and the evidence and outcomes of psychotropic medication dose reduction and/or cessation interventions. Inclusion criteria: This review will consider studies that focus on the use of psychotropic medications amongst patients with ID. Methods: Research studies (qualitative, quantitative and mixed design) and Grey Literature (English) will be included. The search will be conducted without time restrictions. Databases will include: Ovid MEDLINE, Embase, CINAHL, JBI Evidence Synthesis, Cochrane Central Register of Controlled Trials, Cochrane Databased of Systematic Reviews, PsycINFO and Scopus. A three-step search strategy will be followed, with results screened by two independent reviewers. Data will be extracted independently by two reviewers using a data extraction tool with results mapped and presented using a narrative form supported by tables and diagrams.

Modified poly(L-lysine)-based structures as novel antimicrobials for diabetic foot infections, an in-vitro study

Background: Wound infections occur as sequelae to skin trauma and cause significant hospitalizations, morbidity and mortality. Skin traumas arise more frequently in those with diabetes or cardiovascular disease and in these settings, may be chronic with poorer outcomes including lower limb amputation. Treatment of chronic wound infection is challenging due to antibiotic resistance and biofilm formation by bacteria including S. aureus and P. aeruginosa, which are among the most frequent causative pathogens. Managing these challenging infections requires new molecules and modalities. Methods: We evaluated antimicrobial and anti-biofilm activity of star-shaped poly(L-lysine) (PLL) polymers against S. aureus and P. aeruginosa strains and clinical isolates recovered from wounds including diabetic foot wounds (DFW) in a Dublin Hospital in 2019. A star-shaped PLL polypeptide series, specifically G2(8)PLL20, G3(16)PLL10, G4(32)PLL5 with variation in polypeptide chain length and arm-multiplicity, were compared to a linear peptide, PLL160 with equivalent number of lysine residues. Results: All PLLs, including the linear polypeptide, were bactericidal at 1mM against S. aureus 25923 and P. aeruginosa PAO1, with log reduction in colony forming units/ml between 2.7-3.6. PLL160 demonstrated similar killing potency against 20 S. aureus and five P. aeruginosa clinical isolates from DFW, mean log reductions: 3.04 ± 0.16 and 3.96 ± 0.82 respectively after 1 hour incubation. Potent anti-biofilm activity was demonstrated against S. aureus 25923 but for clinical isolates, low to moderate loss of biofilm viability was shown using PLL160 and G3(16)PLL10 at 50 mM (S. aureus) and 200 mM (P. aeruginosa) with high inter-isolate variability. In the star-shaped architecture, antimicrobial activity was retained with incorporation of 5-mer hydrophobic amino-acid modifications to the arms of the polypeptides (series G3(16)PLL20-coPLT5, G3(16)PLL20-coPLI5, G3(16)PLL20-coPLP5). Conclusion: These polypeptides offer structural flexibility for clinical applications and have potential for further development, particularly in the setting of diabetic foot and other chronic wound infections.

An exploration of the consequences of, and coping with loneliness in an ageing intellectual disability population

Background: Loneliness has been associated with hypervigilance and sad passivity. The physiological and psychological reactions of people with an intellectual disability to loneliness have never been investigated. This research aims to explore the outcomes of loneliness for an ageing intellectual disability population. Methods: In Ireland, data from a nationally representative data set of people aged over 40 years with an intellectual disability (N=317) was applied to a social environment model that describes the effects of loneliness in five pre-disease pathways health behaviours, exposure to stressful life events, coping, health and recuperation. The data was tested through chi-squared, ANCOVA and binary logistic regression. Results: Being lonely predicted raised systolic blood pressure (A.O.R=2.051, p=0.039), sleeping difficulties (AOR=2.526, p=0.002) and confiding in staff (AOR=0.464 p=0.008). Additionally, participants who did moderate activity had significantly higher loneliness scores (F=4.171, p<0.05). Conclusions: The analysis supports the concept of hypervigilance in older people with an intellectual disability and limited support for the use of coping mechanisms that differ from those found in the wider population. Future research needs to investigate the longitudinal relationships between loneliness and health.

Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study

Background: Older people are among the most vulnerable patients in acute care hospitals. The hospitalisation process can result in newly acquired functional or cognitive deficits termed hospital associated decline (HAD). Prioritising fundamental care including mobilisation, nutrition, and cognitive engagement can reduce HAD risk. Aim: The Frailty Care Bundle (FCB) intervention aims to implement and evaluate evidence-based principles on early mobilisation, enhanced nutrition and increased cognitive engagement to prevent functional decline and HAD in older patients. Methods: A hybrid implementation science study will use a pragmatic prospective cohort design with a pre-post mixed methods evaluation to test the effect of the FCB on patient, staff, and health service outcomes. The evaluation will include a description of the implementation process, intervention adaptations, and economic costs analysis. The protocol follows the Standards for Reporting Implementation Studies (StaRI). The intervention design and implementation strategy will utilise the behaviour change theory COM-B (capability, motivation, opportunity) and the Promoting Action on Research Implementation in Health Services (i-PARIHS). A clinical facilitator will use a co-production approach with staff. All patients will receive care as normal, the intervention is delivered at ward level and focuses on nurses and health care assistants (HCA) normative clinical practices. The intervention will be delivered in three hospitals on six wards including rehabilitation, acute trauma, medical and older adult wards. Evaluation: The evaluation will recruit a volunteer sample of 180 patients aged 65 years or older (pre 90; post 90 patients). The primary outcomes are measures of functional status (modified Barthel Index (MBI)) and mobilisation measured as average daily step count using accelerometers. Process data will include ward activity mapping, staff surveys and interviews and an economic cost-impact analysis. Conclusions: This is a complex intervention that involves ward and system level changes and has the potential to improve outcomes for older patients.

Health literacy education programmes developed for qualified health professionals: a scoping review protocol

Introduction: Health literacy education, for health professionals, has been identified as having the potential to improve patient outcomes and has been recognized as such in policy developments. Health literacy, as a relational concept, encompasses individuals’ skills and how health information is processed in relation to the demands and complexities of the surrounding environment. Focus has been predominantly on the dimension of functional health literacy (reading, writing and numeracy), although increasing emphasis has been placed on interactive and critical domains. Such dimensions often guide the development of health professional education programmes, where the aim is to enhance the patient-practitioner relationship, and ultimately reduce the health literacy burden experienced by patients navigating health services. Currently little is known about qualified health professionals’ education in health literacy and communication skills, and development, implementation or evaluation of such interventions. Aim: To identify and map current educational interventions to improve health literacy competencies and communication skills of qualified health professionals. Methods: A scoping review will be conducted drawing on methods and guidance from the Joanna Briggs Institute, and will be reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist. This study will retrieve literature on health professional education for health literacy and communication skills through a comprehensive search strategy in the following databases: CINAHL; Medline (Ovid); the Cochrane Library; EMBASE; ERIC; UpToDate; PsycINFO. Grey literature will be searched within the references of identified articles; Lenus; ProQuest E-Thesis Portal; RIAN and OpenGrey. A data charting form will be developed with categories including: article details, demographics, intervention details, implementation and evaluation methods. Conclusion: Little is known about the extent and nature of the current evidence base therefore a scoping review will be conducted, in order to identify programme characteristics in relation to health literacy competencies and communication skills.

Does the use of mobile applications or mobile health technology improve diet quality in adults? A protocol for a systematic literature review

Background: Mobile technology has grown at an exceptional rate and is now a huge part of our daily living. This use of mobile technology has opened up new possibilities in treating health, with almost half of the current applications linked to the mHealth sector. In particular, dietary measurement, applications have become very accessible and very popular. As dietary issues have become more prevalent, more mobile and mHealth applications offer various solutions. This systematic review aims to address if the use of such mobile applications or mobile health technology can improve diet quality in adults that interact with them. Methods: A systematic review of randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) will be conducted. The Cumulative Index to Nursing and Allied Health Literature (Cinahl), The American Psychological Association’s (APA Psycinfo), and PubMed will be searched from January 2010 to November 2021. Primary outcomes will include identifying if adults who use mobile applications and health technology improve their diet quality compared to adults who do not use this technology. Study selection will follow the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines. The methodological appraisal of the studies will be assessed independently by two different reviewers (AS and JR) using the Cochrane Risk-of-Bias Tool for RCTs and the Risk-of Bias In Non-Randomised Studies Tool for NRCTs. Ethics and dissemination: Ethical approval is not essential for this systematic review. Only data from studies that are publically available from previously published studies will be used. The findings of this systematic review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. PROSPERO registration: CRD42021240224 (01/03/2021).

Exploring experiences of supports for suicide bereavement in Ireland: protocol for a national survey

Background A suicide death impacts upon the wellbeing of close family members and friends but has also been shown to affect many people outside of this immediate circle. This will be the first large-scale national study of adults bereaved or affected by suicide in Ireland, using a cross-sectional online survey. The overarching aim will be to gain insight into the experiences of supports received by people bereaved or affected by suicide and to identify the barriers to engagement following their loss. Methods A cross-sectional survey will be conducted among adults in Ireland who have been bereaved or affected by suicide. This project will seek to represent people with different demographics and backgrounds in the Irish population using a multifaceted approach to survey recruitment. A range of validated measures will be used to examine participants’ current wellbeing and grief experience. A combination of closed and open-ended questions will provide participants the opportunity to share their individual experiences, the services and supports available to them, and barriers and enablers to accessing supports. Results Quantitative data will be analysed using descriptive statistics. Chi-squared tests will be used to compare subgroups within categorical data items, and multivariable regression models will be used to examine differences in psychosocial and physical wellbeing across key groups. Qualitative content analysis will be used for qualitative responses to open-ended questions. Conclusions The survey will provide an in-depth understanding of the psychosocial and mental health impacts of suicide bereavement in Ireland; insight into the range of informal and formal supports accessed; and will identify unmet needs and challenges of accessing appropriate and timely supports. The findings will inform current national actions aimed at ensuring the standardisation and quality of the services and supports for those bereaved or affected by suicide.

A systematic review protocol of quantitative instruments of income inequality in studies of children and adolescents

Background: Income inequality is an important indicator of socioeconomic position which is a determinant of social, psychological, and physical health outcomes from childhood to adulthood. Different income inequality instruments (metrics) are used to investigate associations between income inequality and health outcomes (e.g. Gini coefficient, Theil Index). Income inequality instruments provide unique information on the construct of socioeconomic inequality. Albeit there is variation in studies as to the type and rationale for using a particular quantitative instrument of income inequality. The aim of this systematic review will investigate and identify the most used quantitative income inequality instrument in studies of children and adolescents Methods: The PRISMA-P framework will be applied to identify high quality articles (PROSPERO: CRD42021259114). A search will be conducted in PubMed, Embase, and PsycINFO. The search will include studies concerned with income inequality and/or socioeconomic inequality in children and adolescents. All articles will be independently reviewed, data extracted, and quality appraised by two reviewers and a third to arbitrate disputes. Articles will be initially reviewed by title and abstract using inclusion criteria. A data extraction form will be used. Three questions will be answered on the quality of the rationale for using a particular income inequality instrument and the Newcastle-Ottawa Scale will be used to assess bias and quality. The primary outcome of interest is the type and frequency of quantitative income inequality instrument used and the study outcome associated with that income inequality instrument. Conclusions: This systematic review will aim to explore and provide a summary of the different types of quantitative income inequality instruments used in studies of child and adolescent populations. This will help to guide researchers and policy makers on the inclusion and use of income inequality metrics in future studies aimed at understanding associations with health and social outcomes in children and adolescents.

Proficiency-based progression intern training to reduce critical blood sampling errors including ‘wrong blood in tube’

Background: Blood sampling errors including ‘wrong blood in tube’ (WBIT) may have adverse effects on clinical outcomes. WBIT errors occur when the blood sample in the tube is not that of the patient identified on the label. This study aims to determine the effect of proficiency-based progression (PBP) training in phlebotomy on the rate of blood sampling errors (including WBIT). Methods: A non-randomised controlled trial compared the blood sampling error rate of 43 historical controls who had not undergone PBP training in 2016 to 44 PBP trained interventional groups in 2017. In 2018, the PBP training programme was implemented and the blood sampling error rate of 46 interns was compared to the 43 historical controls in 2016. Data analysis was performed using logistic regression analysis adjusting for sample timing. Results: In 2016, 43 interns had a total blood sample error rate of 2.4%, compared to 44 interns in 2017, who had error rate of 1.2% (adjusted OR=0.50, 95% CI 0.36-0.70; <0.01). In 2018, 46 interns had an error rate of 1.9% (adjusted OR=0.89, 95% CI 0.65-1.21; p=0.46) when compared to the 2016 historical controls. There were three WBITs in 2016, three WBITs in 2017 and five WBITs in 2018. Conclusions: The study demonstrates that PBP training in phlebotomy has the potential to reduce blood sampling errors. Trial registration number: NCT03577561