Background Public and Patient Involvement (PPI) refers to the active collaboration of patients and the public in health and social care research decision-making, enhancing research success, cost-effectiveness, and impact. Children, young people, and their families bring unique lived experiences to PPI in research, relating to others with similar experiences, while factors like age, cognitive maturation, and developmental stage create differences between researchers and patients or the public. Collaboration with children, young people, and their families should be guided by specific project context and a strong evidence base. However, existing systematic reviews reveal inconsistencies in reporting and a lack of standardised methods for these groups, limiting effective PPI implementation. This protocol details methods for an umbrella review to identify the current state-of-science and future priorities for collaborating with children, young people and families in health and social care research. Methods The protocol was developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines, which will also direct the reporting of findings. The Joanna Briggs Institute's methodology for conducting umbrella reviews will be adhered to throughout. MEDLINE, CINAHL, EMBASE, PsycINFO, Cochrane, DARE, JBI Evidence Synthesis, PROSPERO, grey literature databases, targeted international networks, and the Google search engine will be searched for systematic reviews on PPI with children, young people, and families in health and social care research. Two reviewers will independently conduct eligibility screening, data extraction, and quality appraisal. Conclusions This umbrella review will provide critical insights into the state-of-science of PPI with children, young people and families in health and social care research. The synthesis of findings could yield important information for researchers and other stakeholders conducting health and social care research in collaboration with children, young people and families by highlighting key patterns, gaps, and recommendations to guide future PPI practices, policies, and research. Registration This umbrella review was registered in PROSPERO, the International Prospective Register of Systematic Reviews (Prospero registration number: CRD42024608935, registered 14th of November 2024).

Background: Incorporating Public and Patient Involvement (PPI) into doctoral research is valued by PhD scholars. The importance of providing early career researchers with appropriate education and training to develop skills to conduct meaningful involvement has been articulated. The Collaborative Doctoral Award in MultiMorbidity (CDA-MM) PhD programme embedded formal PPI training as a postgraduate education component. Four PhD scholars taking part in the CDA-MM established a PPI panel comprising people, and carers of people, living with multimorbidity (≥2 chronic conditions), presenting an opportuning for experiential PPI training. The proposed study aims to evaluate the process and impact of formal and experiential PPI training during a PhD programme. Design: Embedding PPI training in a PhD programme is a novel approach. This evaluation will include a process evaluation to provide an understanding of the workings of the PPI panel and explore the experiences of key stakeholders involved, and an impact evaluation to assess the impact of embedding PPI training in a PhD programme. This study is a longitudinal mixed-methods evaluation, conducted over 24 months. Participants include PhD scholars, PPI contributors and PhD supervisors. An independent researcher not aligned with the CDA-MM will lead the evaluation. Data collection methods include focus groups, individual interviews, an impact log and group reflections. Qualitative data will be analysed using thematic and content analysis and quantitative data will be analysed using descriptive statistics. Discussion: This evaluation will report the learnings from embedding formal and experiential PPI training and education across a PhD programme.

BackgroundDementia is a chronic, progressive and ultimately fatal neurodegenerative disease. Advanced dementia is characterised by profound cognitive impairment, inability to communicate verbally and complete functional dependence. Usual care of people with advanced dementia is not underpinned universally by a palliative approach. Palliative care has focused traditionally on care of people with cancer but for more than a decade, there have been increased calls worldwide to extend palliative care services to include all people with life-limiting illnesses in need of specialist care, including people with dementia.ObjectivesTo assess the effect of palliative care interventions in advanced dementia and to report on the range of outcome measures used.Search methodsWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's Specialized Register on 4 February 2016. ALOIS contains records of clinical trials identified from monthly searches of several major healthcare databases, trial registries and grey literature sources. We ran additional searches across MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), LILACS (BIREME), Web of Science Core Collection (ISI Web of Science), ClinicalTrials.gov and the World Health Organization ICTRP trial portal to ensure that the searches were as comprehensive and as up-to-date as possible.Selection criteriaWe searched for randomised (RCT) and non-randomised controlled trials (nRCT), controlled before-and-after studies (CBA) and interrupted time series studies evaluating the impact of palliative care interventions for adults with dementia of any type, staged as advanced dementia by a recognised and validated tool. Participants could be people with advanced dementia, their family members, clinicians or paid care staff. We included clinical interventions and non-clinical interventions. Comparators were usual care or another palliative care intervention. We did not exclude studies on the basis of outcomes measured and recorded all outcomes measured in included studies.Data collection and analysisTwo review authors independently assessed for inclusion all the potential studies we identified as a result of the search strategy. We resolved any disagreement through discussion or, when required, consulted with the rest of the review team. We independently extracted data and conducted assessment of methodological quality, using standard Cochrane methods.Main resultsWe identified two studies of palliative care interventions for people with advanced dementia. We did not pool data due to the heterogeneity between the two trials in terms of the interventions and the settings. The two studies measured 31 different outcomes, yet they did not measure the same outcome. There are six ongoing studies that we expect to include in future versions of this review.Both studies were at high risk of bias, in part because blinding was not possible. This and small sample sizes meant that the overall certainty of all the evidence was very low.One individually randomised RCT (99 participants) evaluated the effect of a palliative care team for people with advanced dementia hospitalised for an acute illness. While this trial reported that a palliative care plan was more likely to be developed for participants in the intervention group (risk ratio (RR) 5.84, 95% confidence interval (CI) 1.37 to 25.02), the plan was only adopted for two participants, both in the intervention group, while in hospital. The palliative care plan was more likely to be available on discharge in the intervention group (RR 4.50, 95% CI 1.03 to 19.75). We found no evidence that the intervention affected mortality in hospital (RR 1.06, 95% CI 0.53 to 2.13), decisions to forgo cardiopulmonary resuscitation in hospital or the clinical care provided during hospital admission, but for the latter, event rates were low and the results were associated with a lot of uncertainty.One cluster RCT (256 participants, each enrolled with a family carer) evaluated the effect of a decision aid on end-of-life feeding options on surrogate decision-makers of nursing home residents with advanced dementia. Data for 90 participants (35% of the original study) met the definition of advanced dementia for this review and were re-analysed for the purposes of the review. In this subset, intervention surrogates had lower scores for decisional conflict measured on the Decisional Conflict Scale (mean difference -0.30, 95% CI -0.61 to 0.01, reduction of 0.3 to 0.4 units considered meaningful) and were more likely than participants in the control group to discuss feeding options with a clinician (RR 1.57, 95% CI 0.93 to 2.64), but imprecision meant that there was significant uncertainty about both results.Authors' conclusionsVery little high quality work has been completed exploring palliative care interventions in advanced dementia. There were only two included studies in this review, with variation in the interventions and in the settings that made it impossible to conduct a meta-analysis of data for any outcome. Thus, we conclude that there is insufficient evidence to assess the effect of palliative care interventions in advanced dementia. The fact that there are six ongoing studies at the time of this review indicates an increased interest in this area by researchers, which is welcome and needed.

The research community is responding with speed to the COVID-19 pandemic, with rapid response mechanisms to fund research, shortened application turnaround times, and expedited research ethics processes. Public and patient involvement (PPI) is under pressure in this rapid response research, where it is easy for researchers and funders to dismiss PPI as non-essential, an added extra, a “nice to have”. In this open letter, we, researchers and PPI contributors, argue that PPI is important, now more than ever. The pandemic is impacting everyone in society, with normal rules of engagement discarded. The solution to overcoming this virus will come from many different sources and many changes will emerge to healthcare delivery and to how we live our lives. It is essential that the research to find solutions is shaped by all who will be impacted: the public and the patient must be central contributors and their voice must be hear.

Background Despite efforts to improve the accuracy and transparency of the design, conduct, and reporting of randomised controlled trials (RCTs), deficiencies remain. Such deficiencies contribute to significant, avoidable waste of health research investment and impede reproducibility. This study aimed to synthesise and critically analyse changes over time in the conduct and reporting of internationally published evidence on patient and/or population health-oriented RCTs conducted in one country. Methods This observational study drew on systematic review methods. We searched six databases for published RCTs (database inception to December 2018) where ≥ 80% of participants were recruited in the Republic of Ireland. RCTs of interventions targeted at patients, providers and/or policy makers intended to improve health, healthcare or health research were included. For each study, screening, data extraction and methodological quality appraisal were conducted by one member of the author team. Results From 17,560 titles and abstracts, 752 unique RCTs were published in 745 papers between 1968 and 2018, with a steady year-on-year increase since 1968. The number of participants was in the range of 2–8628. The majority were parallel design (86%) and classified as treatment evaluation. Of the 418 RCTs published since the introduction of mandatory clinical trial registration by the International Committee of Medical Journal Editors in 2005, 32% ( n = 134) provided a trial registration number. This increased to 47% when taking studies published between 2013 and 2018 ( n = 232). Since the 1996 publication of the CONSORT statement, 16% of included RCTs made specific reference to a standardised reporting guideline and this increased to 31% for more recent studies published between 2013 and 2018. Overall, 7% ( n = 53) of studies referred to a published study protocol, increasing to 20% for studies published between 2013 and 2018. Conclusion Evidence from this single-country study of RCTs published in the international literature suggests that both the number overall, the number registered and the number referencing reporting guidelines have increased steadily over time. Despite widespread endorsement of reporting standards, reporting of RCTs remains suboptimal in domains such as compliance with the CONSORT statement and prospective trial registration. Researchers, funders and journal editors, nationally and internationally, should continue to focus on improving reporting and examining avoidable waste of health research investment.

The research community is responding with speed to the COVID-19 pandemic, with rapid response mechanisms to fund research, shortened application turnaround times, and expedited research ethics processes. Public and patient involvement (PPI) is under pressure in this rapid response research, where it is easy for researchers and funders to dismiss PPI as non-essential, an added extra, a “nice to have”. In this open letter, we, researchers and PPI contributors, argue that PPI is important, now more than ever. The pandemic is impacting everyone in society, with normal rules of engagement discarded. The solution to overcoming this virus will come from many different sources and many changes will emerge to healthcare delivery and to how we live our lives. It is essential that the research to find solutions is shaped by all who will be impacted: the public and the patient must be central contributors and their voice must be hear.

The University College Dublin (UCD) Public and Patient Invovlement (PPI) ignite program is focused on embedding PPI in health and social care related research, education and training, professional practice and administration. During a PPI knowledge sharing event challenges were noted during the pre-commencement stage of research projects. This stage includes the time before a research projects/partnership starts or when funding is being applied for. As a response, we agreed there was a need to spend time developing a values-based approach to be used from the pre-commencement of PPI projects and partnerships. Values are deeply held ideals that people consider to be important. They are vital in shaping our attitudes and motivating our choices and behaviours. Using independent facilitators, we invited a diverse group of participants to a full-day workshop in February. During the workshop, the concept of a values statement and values-based approaches was introduced. The group via a majority consensus, agreed on a core set of values and a shared understanding of them. After the workshop, a draft was shared with participants for further comment and final agreement. The workshop had 22 people representing experts by experience, PPI charity partners, funders, academics and national PPI Ignite partners. The group via consensus identified four values of respect, openness, reciprocity and flexibility for the pre-commencement stage. A frequently reported experience of PPI partners was that some felt that the pre-commencement activities appeared at times like a performance; an act that had to be completed in order to move to the next stage rather than a genuine interest in a mutually beneficial partnership. Being open and transparent with all invovled that the funding application may not be successful was stressed. Another important feature related to ‘openness’ was the ‘spaces’ and ‘places’ in which meetings between partners could occur in an accessible and equitable way. The issue of ‘space’ is particularly critical for the involvement of seldom heard groups. The benefits of the research are often clear for academics, but for PPI partners, these are often less certain. To achieve reciprocity, academic and PPI partners need to engage in a timely, repeated and transparent dialogue to achieve beneficial outcomes for all stakeholders. Being open to new inputs and differing modes of knowledge and ideas was also stressed. For some, this will require a change in attitudes and behaviours and should result in more collective decision making. Several areas were identified using the four values. This work via majority consensus identified four values of respect, openness, reciprocity, and flexibility for the pre-commencement stage. These values should be used to support inclusive, effective and collective PPI across all stages of involvement. We hope this work will stimulate further action in this area. In particular, we would welcome the evaluation of these values involving diverse PPI groups.

Benralizumab was approved in the U.S. in November 2017 for patients 12 years and older with severe eosinophilic asthma. Pivotal trials have shown reduction in asthma exacerbations at 48- and 56-weeks treatment with benralizumab, however, real-life evaluation of efficacy is limited.

AIM The aim of this randomized controlled trial was to examine the impact of daily supportive text messages over a 6-month treatment period on mood and alcohol consumption in individuals with a dual diagnosis of alcohol use disorder (AUD) and depression following completion of an inpatient treatment programme. METHOD Ninety-five adult participants with AUD and comorbid depression were recruited into this randomized control trial, which took place after completing a 30-day rehabilitation programme. The intervention group (n = 47) received twice-daily supportive text messages over 6-months while control participants (n = 48) had treatment as usual for a 6-month period, with an added 6-month post-treatment follow-up for both groups. Drinking history in the previous 90 days as well as symptoms of depression, anxiety and stress were measured at baseline, 3- and 6-month treatment points and 6-month post treatment follow up. RESULTS Depression scores (P = 0.02) and perceived stress scores (P < 0.01) were significantly reduced at 3-month treatment point in the intervention group relative to control participants with small to medium effect. The intervention group also showed a significantly greater reduction in units per drinking day from baseline to 6-month treatment point compared to the control group with a medium effect size (P = 0.03). There were no differences in drinking or mood measures at 6-month post treatment follow-up. CONCLUSIONS Supportive text messages provide an early initial benefit in decreasing symptoms of depression and stress, with a further positive impact on alcohol consumption following a longer treatment period. Benefits did not persist six months after the intervention ended.

Background: While there is growing public and patient involvement (PPI) in health research in Ireland, there is little information on the extent to which PPI has permeated the field of health economics research. The aim of this scoping study is to explore the knowledge and use of PPI among health economists in Ireland. Methods: This paper is based on a survey questionnaire administered electronically to all members of Health Economics Association of Ireland (HEAI). The study provides a baseline audit on the knowledge and use of PPI in health economics research. A review of the international literature on the interface between PPI and health economics informed the design of the questions used in the survey. Results: Half of respondents incorporate PPI in their health economics research. Two thirds report their knowledge of PPI as weak or fair; only 8% say it is excellent. PPI, when it occurs, is largely focused on the identification of research priorities and appropriate outcomes. Just over one third of respondents currently evaluate their PPI activities in health economic research; there is almost no focus on impact as part of the evaluation process. Conclusion: Health economists in Ireland do not have a strong knowledge of PPI, either in practice or in theory. They find PPI challenging due to limited time, resources, information and the absence of appropriate skills to engage patients and the public in their work. Education and training are needed to support greater use of PPI in health economics research.

Purpose. Patients with coronary heart disease (CHD) experience reduced quality of life which may be associated with mortality in the longer term. This study explores whether patient-rated physical and mental health status was associated with mortality at 6-year follow-up among patients with CHD attending primary care in Ireland and Northern Ireland. Methods. This study is a secondary data analysis of patients with CHD recruited to a cluster randomized controlled trial from 2004 to 2010. Data collected included patient-rated physical component summary (PCS) and mental component summary (MCS) scores of health status (from the 12-Item Short-Form Health Survey (SF-12)), demographics and clinical parameters at baseline, and all-cause mortality at 6-year follow-up. Multivariate regression was conducted using generalized estimating equations (GEE) with a log-link function. Results are presented as odds ratios (ORs) and 95% confidence intervals (CIs). Results. The study consisted of 762 individuals with mean age 67.6 years [standard deviation (SD): 9.8], and was 29% female. Mean baseline SF-12 mental (MCS) and physical (PCS) component scores were 50.0 (SD: 10.8) and 39.6 (SD: 11.2), respectively. At 6-year follow-up, the adjusted OR for the baseline MCS for mortality was 0.97 (95% CI: 0.95-0.99) and for the PCS 0.97 (95% CI: 0.95-0.99). For every five-point increase in MCS and PCS scores, there was a 14% reduction in the likelihood of all-cause mortality. Conclusions. Overall, the magnitude of effect for both mental health status and physical health status was similar; higher scores were significantly associated with a lower risk of mortality at 6-year follow-up.

This is a protocol for a Cochrane Review (Methodology). The objectives are as follows: To evaluate the effectiveness of design‐based methods to influence the completeness of item response to self‐administered questionnaires. This will be achieved by assessing the effects of aspects of style, appearance and layout of self‐administered questionnaires on the proportion of items completed in returned questionnaires.

While cardiac secondary prevention in primary care is established practice, little is known about its long-term cost effectiveness. This study examines the cost effectiveness of a secondary prevention intervention in primary care in the Republic of Ireland and Northern Ireland over 6 years. An economic evaluation, based on a cluster randomised controlled trial of 903 patients with heart disease, was conducted 4.5 years after the intervention ceased to be delivered. Patients originally randomised to the control received usual practice while those randomised to the intervention received a tailored care package over the 1.5-year delivery period. Data on healthcare costs and quality adjusted life expectancy were used to undertake incremental cost utility analysis. Multilevel regression was used to estimate mean cost effectiveness and uncertainty was examined using cost effectiveness acceptability curves. At 6 years, there was a divergence in the results across jurisdictions. While the probability of the intervention being cost effective in the Republic of Ireland was 0.434, 0.232, 0.180, 0.150, 0.115 and 0.098 at selected threshold values of €5000, €15,000, €20,000, €25,000, €35,000 and €45,000, respectively, all equivalent probabilities for Northern Ireland equalled 1.000. Our findings suggest that the intervention in its current format is likely to be more cost effective than usual general practice care in Northern Ireland, but this is not the case in the Republic of Ireland.

Introduction Alcohol use disorders (AUDs) and mood disorders commonly co-occur, and are associated with a range of negative outcomes for patients. Mobile phone technology has the potential to provide personalised support for such patients and potentially improve outcomes in this difficult-to-treat cohort. The aim of this study is to examine whether receiving supporting SMS text messages, following discharge from an inpatient dual diagnosis treatment programme, has a positive impact on mood and alcohol abstinence in patients with an AUD and a comorbid mood disorder. Methods and analysis The present study is a single-blind randomised controlled trial. Patients aged 18–70 years who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV Axis I will be randomised to receive twice-daily supportive SMS text messages for 6 months plus treatment as usual, or treatment as usual alone, and will be followed-up at 3, 6, 9 and 12 months postdischarge. Primary outcome measures will include changes from baseline in cumulative abstinence duration, which will be expressed as the proportion of days abstinent from alcohol in the preceding 90 days, and changes from baseline in Beck Depression Inventory scores. Ethics and dissemination The trial has received full ethical approval from the St. Patrick’s Hospital Research Ethics Committee (protocol 13/14). Results of the trial will be disseminated through peer-reviewed journal articles and at academic conferences. Trial registration number NCT02404662; Pre-results.