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    Use of participant data and biological samples is insufficiently described in participant information leaflets
    (Elsevier Inc., 2025-11-03) McGrath, Emer R.; Kirby, Nigel; Shiely, Frances
    Background: With greater availability of participant data and biobank repositories following clinical trial completion, adequately describing future data and biological sample reuse plans to trial participants is increasingly important. We evaluated how trial teams currently describe current and future use of participant data and biological samples in participant information leaflets (PILs). Methods: Retrospective qualitative analysis of 240 PILs (182 clinical trials) in Ireland and the UK. Descriptions of data and sample use/reuse were extracted and analyzed using a 4-stage pragmatic content analysis approach. A recommended list of questions to be addressed by trial teams when designing PILs was developed. Results: Of the 240 included PILs, 85% specifically mentioned, or directly implied, how confidentiality of participant data would be maintained; 38% were considered by the authors to adequately describe how data confidentiality would be maintained (ie, the PIL specifically mentioned data deidentification and compliance with data protection regulations); 47% reported the intended duration of data storage (mean 15; SD ± 9 years); 40% specified if data would be used in future research studies and 28% stated if data would be shared with other researchers. Of the 117 PILs stating biological samples would be collected from participants, 80% provided a reason for requesting the sample, 66% stated whether stored samples would be deidentified, 21% specified if individual-level results would be made available to participants and 70% specified whether samples may be used for future studies. Of the 73 PILs specifying planned future sample storage, 18% stated the intended duration of storage and 48% specified if samples would be shared with other researchers. A list of 8 recommended questions to be addressed by trial teams when designing PILs were identified, for example, ‘What is the intended duration of data and sample storage for the current study?’. Conclusions: PILs often provide insufficient detail regarding plans for current use and future reuse of participants’ data and their biological samples. The majority do not adequately describe plans for maintaining data confidentiality. Best practice approaches to describing data use and reuse in PILs are needed. This will require multistakeholder input, including potential trial participants to progress this.
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    Factors influencing smartwatch use and comfort with health data sharing: a sequential mixed-method study protocol
    (BMJ Journals, 2024) Goodings, Anthony James; Fadahunsi, Kayode Philip; Tarn, Derjung Mimi; Henn, Patrick; Shiely, Frances; O'Donoghue, John
    Introduction Smartwatches have become ubiquitous for tracking health metrics. These data sets hold substantial potential for enhancing healthcare and public health initiatives; it may be used to track chronic health conditions, detect previously undiagnosed health conditions and better understand public health trends. By first understanding the factors influencing one’s continuous use of the device, it will be advantageous to assess factors that may influence a person’s willingness to share their individual data sets. This study seeks to comprehensively understand the factors influencing the continued use of these devices and people’s willingness to share the health data they generate. Methods and analysis A two-section online survey of smartwatch users over the age of 18 will be conducted (n ≥200). The first section, based on the expectation-confirmation model, will assess factors influencing continued use of smartwatches while the second section will assess willingness to share the health data generated from these devices. Survey data will be analysed descriptively and based on structural equation modelling. Subsequently, six focus groups will be conducted to further understand the issues raised in the survey. Each focus group (n=6) will consist of three smartwatch users: a general practitioner, a public health specialist and an IT specialist. Young smartwatch users (aged 18–44) will be included in three of the focus groups and middle-aged smartwatch users (aged 45–64) will be included in the other three groups. This is to enhance comparison of opinions based on age groups. Data from the focus groups will be analysed using the microinterlocutor approach and an executive summary. After the focus group, participants will complete a brief survey to indicate any changes in their opinions resulting from the discussion. Ethics and dissemination The results of this study will be disseminated through publication in a peer-reviewed journal, and all associated data will be deposited in a relevant, publicly accessible data repository to ensure transparency and facilitate future research endeavours.
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    Energy retrofits: factors affecting a just transition to better indoor air quality
    (Elsevier, 2024) Coggins, Ann Marie; Hogan, Victoria; Mishra, Asit Kumar; Norton, Daniel; Foster, Declan; Wemken, Nina; Cowie, Hilary; Doherty, Edel
    In comparison with other European countries, Ireland has a disproportionately high number of poorly performing energy-inefficient buildings. Consequently, Ireland has one of the most ambitious energy retrofit programmes in Europe. The aim of this study was to evaluate the impact of deep energy renovation measures i.e. (replacement of heating system and upgrade to building envelope) on indoor air quality, thermal comfort and ventilation in a sample of primarily social housing in Ireland. A mixed methods approach including measurement of indoor air quality and a thermal comfort questionnaire survey was employed. Indoor concentration measurements of PM 2.5 , carbon dioxide, formaldehyde, and radon along with measurements of air temperature and relative humidity were made (N=14). Occupants (n=56) completed a thermal comfort questionnaire survey pre- and post-retrofit. Data collection ran from autumn 2020 until autumn 2023. Thermal comfort improved post-retrofit along with occupant satisfaction with the indoor thermal environment and heating-systems. Post-retrofit, higher bedroom CO 2 , and higher PM 2.5 concentrations were recorded in both living areas and bedrooms. Occupant behaviours e.g. blocking wall vents were significant predictors of poorer ventilation while smoking indoors was related to higher concentrations of PM 2.5 . In general, homes that had mechanical ventilation systems installed were better ventilated. Underventilation, as indicated by visible condensation or mould was observed in half of the social homes surveyed and reported by questionnaire respondents (26 %). Tailored communications to occupants regarding the important role of ventilation and indoor air quality is required as part of retrofit to optimise impacts on IEQ.
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    Prescriber adherence to antihypertensive prescription guidelines and the impact of patient socioeconomic factors: a cross‐sectional study using data from the irish longitudinal study on ageing
    (Wiley, 2024) Akhtar, Alizeh; Burton, Edel; Bermingham, Margaret; Kearney, Patricia M.; Irish Research eLibrary
    Purpose Uncontrolled hypertension causes significant morbidity and mortality worldwide. Several prescribing guidelines have been created to address this, however, prescriber adherence to guidelines is influenced by various sociodemographic patient factors. This study aims to determine the effects of these patient factors on prescriber adherence to antihypertensive prescription guidelines. Methods A secondary analysis of data from the first wave of The Irish Longitudinal Study on Ageing (TILDA), was conducted. Participants were included if they reported previous hypertension diagnoses. Antihypertensive medication regimes were compared with the prescribing guidance in the 2011 NICE hypertension guidelines. The effects of patient sociodemographic factors on prescriber adherence to guidelines, and the effect of prescriber adherence on blood pressure control (≥ 140/90 mmHg), were determined using binomial logistic regression models. Results A total of 2992 participants were included in this analysis; 54.9% female with mean age 65.7 years (±9.23). Male sex and older age, and lower socioeconomic status were associated with increased prescriber guideline adherence. Prescribers were less likely to adhere to guidelines in female patients ≥ 55 years (Relative Risk [RR] 0.75 [0.62, 0.91]), and female patients across all age groups (RR 0.80 [0.67, 0.95]). Better blood pressure control was seen with medication regimes adherent to prescription guidelines (140.38 (±18.98)/83.09 (±11.02) mmHg adherent vs. 141.66 (±19.86)/84.77 (±11.71) mmHg non-adherent). Conclusions This study highlights the effect of patient sex on prescriber adherence to antihypertensive prescription guidelines, emphasizing a larger issue of systemic undertreatment of females observed within healthcare. Further research is needed to determine the reasons for such differences in hypertensive care.
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    Determinants of receiving child protection and welfare services following initial assessment: A cross-sectional study from the Republic of Ireland
    (Elsevier Ltd., 2024-05-13) O'Leary, Donna; Christie, Alistair; Perry, Ivan J.; Khashan, Ali S.; Irish Research Council; Child and Family Agency
    Background: Children receive child protection and welfare services when an initial assessment concludes that their needs and care would be significantly compromised without intervention or support. Evidence is lacking on this decision to provide services in the Irish child protection and welfare system. Objective: To identify determinants of receiving services following an Initial Assessment. Participants and Setting: All children (n = 508) whose Initial Assessments were completed during the first quarter of 2016 in one of the four regions (spanning seven social work departments) of Tusla, the national Child and Family Agency. Methods: A cross-sectional study used data manually coded from social workers’ case records. Poisson regression analysis calculated incident rate ratios for receiving ongoing service, adjusting for demographic factors, family level and wider determinants of child welfare to investigate associations between predictor variables and the decision to provide services. Results: 38.5 % of children (n = 185) received ongoing child protection and welfare services. Risk factors for service provision included mother-perpetrated domestic violence (Incident Rate Ratio (IRR) 1.70 (95 % Confidence Interval (CI) 1.33, 2.19)), concerns about guidance and boundaries (IRR 1.66 (95 % CI 1.29, 1.14)), lack of emotional warmth (IRR 1.62 (95 % CI 1.30, 2.02)), prior abuse (IRR 1.59 (95 % CI 1.30, 1.95)), prior involvement (IRR 1.51 (95 % CI 1.15, 1.98)), intergenerational involvement (IRR 1.40 (95 % CI 1.10, 1.76)), health concerns (IRR 1.30 (95 % CI 1.07, 1.57)), and being aged 0–4 years (IRR 1.28 (95 % CI 1.03, 1.59)). Being reported by mandated professionals (IRR 0.71 (95 % CI 0.56, 0.90)), assessed by female social workers (IRR 0.72 (95 % CI 0.59, 0.89)), and, when separately examined, parental cooperation (IRR 0.64 (95 % CI 0.53, 0.77)) reduced the likelihood of receiving service. No differences were noted between departments. Conclusions: Service provision is largely driven by parental factors, prior involvement, and intergenerational abuse but gender disparities exist. Findings can be used to enhance decision strategies to improve outcomes for children and families.