Toward best practice methods for delirium biomarker studies: An international modified Delphi study

Background: Delirium is a serious and distressing neurocognitive condition common in people with advanced illness. The understanding of delirium pathophysiology is limited and largely hypothetical. To accelerate empirical understanding of delirium pathophysiology, robust scientific methods for conducting and reporting delirium biomarker studies are urgently needed. The aim of this study was to develop international consensus on the core elements of high‐quality delirium biomarker studies. Methods: A three‐round modified Delphi survey was conducted from February to August 2019. Participants were international researchers experienced in conducting delirium studies from a range of settings (hospital, university, research centres). Round one commenced with open‐ended questions developed from results from a prior systematic review and the REMARK (REporting recommendations for tumour MARKer prognostic studies) checklist. Responses were qualitatively analysed, and closed statements were developed. Participants then ranked the importance of these statements using a 5‐point Likert scale in rounds 2 and 3. A priori consensus was defined as ≥70% participant agreement. Descriptive statistics for each item were computed including the mean Likert scores, SD and median participant scores. Results: Twenty-eight participants completed survey round one, 16 completed round two and 19 completed the final round. Consensus was achieved for a total of 60 items. Conclusion: The Delphi survey identified items that expert researchers agreed were important in the conduct of delirium biomarker studies. These reporting items provide a strong platform for improved methodological quality and opportunities to synthesise future delirium biomarker studies

Older persons’ and their caregivers’ perspectives and experiences of research participation with impaired decision-making capacity: A scoping review

Background and Objectives: Human research ethics statements support equitable inclusion of diverse groups. Yet older people are under-represented in clinical research, especially those with impaired decision-making capacity. The aim of this study was to identify perspectives and experiences of older persons and their caregivers of research participation with impaired decision-making capacity. Research Design and Methods: Scoping review of literature and online sources in January-February 2019 (updated June 2020) according to Joanna Briggs Institute methodology and PRISMA Extension for Scoping Reviews. English-language peer-reviewed research articles and Australian online narratives were included. Data were tabulated and narratively synthesized. Results: From 4171 database records and 93 online resources, 22 articles (2000-2019, 82% United States, 16 first authors) and one YouTube webinar (2018) were initially included; updated searches yielded an additional article (2020) and YouTube webinar (2020). Studies were heterogeneous in terminology, methods and foci, with hypothetical scenarios, quantitative analyses and examination of proxy consent predominating. Participants (n=7331) were older persons (71%), caregivers of older persons with dementia/cognitive impairment (23%) and older persons with dementia/cognitive impairment (6%). Synthesis identified two themes: willingness to participate and decision-making approaches. Discussion and Implications: Research participation by older persons with dementia may be optimized through reducing risks and burdens and increasing benefits for participants, greater consumer input into study development, and shared and supported decision-making. Older persons’ and caregivers’ perspectives and experiences of research participation with impaired decision-making capacity require investigation in a greater range of countries and conditions other than dementia, and dissemination through more varied media

The Koolungar Moorditj Healthy Skin Project: Elder and Community Led Resources Strengthen Aboriginal Voice for Skin Health

In partnership with local Aboriginal Community Controlled Health Organisations, the Elder-led co-designed Koolungar Moorditj Healthy Skin project is guided by principles of reciprocity, capacity building, respect, and community involvement. Through this work, the team of Elders, community members, clinicians and research staff have gained insight into the skin health needs of urban-living Aboriginal koolungar (children); and having identified a lack of targeted and culturally appropriate health literacy and health promotion resources on moorditj (strong) skin, prioritised development of community-created healthy skin resources. Community members self-appointed to Aboriginal Community Advisory Groups (CAG) on Whadjuk (Perth) and Wardandi (Bunbury) boodjar (land/place) provided local leadership and led the development of moorditj skin resources. Over several online and face-to-face meetings facilitated by an Aboriginal project officer, CAG members shared local perspectives and cultural knowledge to develop and inform the messaging, medium, and dissemination of health literacy and health promotion resources for healthy skin. All CAG-created research approaches, resources and materials were presented to the Elder Researchers for discussion, final review, and implementation by the project team. Culturally appropriate moorditj skin resources, designed by community for community, build on knowledge of healthy skin to achieve moorditj skin and moorditj health for urban-living Aboriginal koolungar

Development of the Reporting Essentials for DElirium bioMarker Studies (REDEEMS) guideline

Background Delirium is a serious and distressing neurocognitive condition manifesting as an acute change in mental status due to medical illness, injury and/or treatment. The understanding of delirium pathophysiology is limited and largely hypothetical and this evidence gap impedes the development of effective therapies. Delirium biomarker studies have a key role in building knowledge of the pathophysiology of delirium, subject to the robustness of their methods and reporting. Our objective was to describe the multi-method development and finalisation of a new reporting guideline for delirium fluid biomarker studies: REDEEMS. Methods A previously published systematic review on delirium and advanced cancer biomarkers informed a three-round modified Delphi study with international experts in delirium research in 2019. We held a follow-up consensus meeting with a newly configured expert panel of 12 delirium researchers in June, 2020 to determine the inclusion or exclusion of 16 items that achieved 70-80% (i.e., borderline) consensus in the Delphi study. Results Of the 16 items presented at the consensus meeting, seven were excluded, six remained as discrete items, and three were merged with another item. The final REDEEMS guideline contained nine items specific to reporting delirium biomarker studies. Conclusion The REDEEMS guideline was developed through a rigorously conducted Delphi and follow-up consensus meeting with international experts in delirium research. The REDEEMS will support the improved reporting rigour and synthesis of future delirium biomarker research. The next step is dissemination to promote uptake of the guideline and evaluate the influence on improved study methods and capacity to address research hypotheses

Delirium researchers\u27 perspectives of the challenges in delirium biomarker research: A qualitative study

Background: Despite the prevalence and impact of delirium, its pathophysiology remains unclear. In order to advance this field of research, robust scientific methodology is required, yet quality of reporting in this field of research has been highly inconsistent. Delirium biomarker research poses several challenges, none of which have been documented in the literature before. The aim of this study was to explore the perspectives of delirium researchers about key methodological issues in delirium biomarker research. Methods: Following a Delphi study with delirium experts resulting in 60 recommendations for reporting delirium biomarker studies, semi-structured interviews with international delirium researchers were conducted. Interviews were audio-taped and transcribed verbatim, followed by thematic analysis of the qualitative data. Results: Fifteen participants were interviewed between August and November 2019. Most were male (n = 12; 75%), clinician researchers (n = 13; 86%), and had more than ten years’ experience in conducting delirium research (n = 9; 60%). Analysis revealed two major themes and ten sub-themes, outlining key considerations to advance the field of delirium biomarker research. The major themes were: 1) Practical and scientific challenges of delirium biomarker research: stagnation versus driving improved methods and reporting; and 2) Valuing delirium research through investment and collaboration. Conclusions: Findings identified a range of factors that contribute to the practical and ethical challenges of conducting delirium biomarker research, which have not previously been explicitly acknowledged or reported. A clear vision for collaborative efforts to enhance research quality for improved impact was also presented by the delirium researchers. This work complements the preceding Delphi and together these studies provide an in-depth understanding of what is needed in the field to inform and improve methods and reporting of delirium biomarker research

Inclusion, characteristics and outcomes of people requiring palliative care in studies of non-pharmacological interventions for delirium: A systematic review

© The Author(s) 2019. Background: Delirium is common, distressing, serious and under-researched in specialist palliative care settings. Objectives: To examine whether people requiring palliative care were included in non-pharmacological delirium intervention studies in inpatient settings, how they were characterised and what their outcomes were. Design: Systematic review (PROSPERO 2017 CRD42017062178). Data sources: Systematic search in March 2017 for non-pharmacological delirium intervention studies in adult inpatients. Database search terms were ‘delirium’, ‘hospitalisation’, ‘inpatient’, ‘palliative care’, ‘hospice’, ‘critical care’ and ‘geriatrics’. Scottish Intercollegiate Guidelines Network methodological checklists guided risk of bias assessment. Results: The 29 included studies were conducted between 1994 and 2015 in diverse settings in 15 countries (9136 participants, mean age = 76.5 years (SD = 8.1), 56% women). Most studies tested multicomponent interventions (n = 26) to prevent delirium (n = 19). Three-quarters of the 29 included studies (n = 22) excluded various groups of people requiring palliative care; however, inclusion criteria, participant diagnoses, illness severity and mortality indicated their presence in almost all studies (n = 26). Of these, 21 studies did not characterise participants requiring palliative care or report their specific outcomes (72%), four reported outcomes for older people with frailty, dementia, cancer and comorbidities, and one was explicitly focused on people receiving palliative care. Study heterogeneity and limitations precluded definitive determination of intervention effectiveness and only allowed interpretations of feasibility for people requiring palliative care. Acceptability outcomes (intervention adverse events and patients’ subjective experience) were rarely reported overall. Conclusion: Non-pharmacological delirium interventions have frequently excluded and under-characterised people requiring palliative care and infrequently reported their outcomes

Eating and drinking-related care for persons with advanced dementia in long-term care

Background: Advanced dementia is a life-limiting illness that requires a palliative approach to care. Decline in eating/drinking represents a milestone in progression that warrants decision-making and planning of care. In long-term care (LTC), this is best conducted via family case conferences. Aim: To explore decision-making and planning regarding eating/drinking-related care in case conferences for persons with advanced dementia in LTC to inform future practice. Methods: A qualitative approach was taken, using observation of audio-recorded case conferences. Case conferences were conducted in 6 LTC facilities within the intervention arm of a cluster randomized controlled trial. Participants were LTC personnel, doctors, and families of persons with advanced dementia. Content was analysed for eating/drinking-related goals of care and the degree to which decision-making was shared. Findings: Thirty-two case conferences considered eating/drinking-related care. The goals included nutrition, hydration, weight gain and maintenance, food enjoyment, social interaction, and independence. Key considerations included secondary health issues impacting comfort, and tensions between food enjoyment versus nutrition and risk of aspiration. While families contributed essential information about eating/drinking history, sometimes decision-making was dominated by professionals and overlooked overall goals of care. Discussion: Shared decision-making regarding eating/drinking-related care for persons with advanced dementia in LTC should start with consensus on overall goals of care and include contributions to quality of life as well as risks. Family involvement should be supported beyond information-giving. Conclusion: Future studies are needed to identify the most sensitive and understandable ways for families of discussing eating/drinking-related decline in dementia.</p

Reporting Essentials for DElirium bioMarker Studies (REDEEMS): Explanation and Elaboration

Despite many studies of potential delirium biomarkers, delirium pathophysiology remains unclear. Evidence shows that the quality of reporting delirium biomarker studies is sub-optimal. Better reporting of delirium biomarker studies is needed to understand delirium pathophysiology better. To improve robustness, transparency and uniformity of delirium biomarker study reports, the REDEEMS (Reporting Essentials for DElirium bioMarker Studies) guideline was developed by an international group of delirium researchers through a three-stage process, including a systematic review, a three-round Delphi study, and a follow-up consensus meeting. This process resulted in a 9-item guideline to inform delirium fluid biomarker studies. To enhance implementation of the REDEEMS guideline, this Explanation and Elaboration paper provides a detailed explanation of each item. We anticipate that the REDEEMS guideline will help to accelerate our understanding of delirium pathophysiology by improving the reporting of delirium biomarker research and, consequently the capacity to synthesise results across studies

Older Persons’ and Their Caregivers’ Perspectives and Experiences of Research Participation With Impaired Decision-Making Capacity: A Scoping Review

Background and Objectives: Human research ethics statements support the equitable inclusion of diverse groups. Yet older people are underrepresented in clinical research, especially those with impaired decision-making capacity. The aim of this study was to identify the perspectives and experiences of older persons and their caregivers of research participation with impaired decision-making capacity. Research Design and Methods: Scoping review of the literature and online sources in January-February 2019 (updated June 2020) according to Joanna Briggs Institute methodology and PRISMA Extension for Scoping Reviews. English-language peer-reviewed research articles and Australian online narratives were included. Data were tabulated and narratively synthesized. Results: From 4,171 database records and 93 online resources, 22 articles (2000-2019, 82% United States, 16 first authors) and one YouTube webinar (2018) were initially included; updated searches yielded an additional article (2020) and YouTube webinar (2020). Studies were heterogeneous in terminology, methods, and foci, with hypothetical scenarios, quantitative analyses, and examination of proxy consent predominating. Participants (N = 7,331) were older persons (71%), caregivers of older persons with dementia/cognitive impairment (23%), and older persons with dementia/cognitive impairment (6%). Synthesis identified 2 themes: willingness to participate and decision-making approaches. Discussion and Implications: Research participation by older persons with dementia may be optimized through reducing risks and burdens and increasing benefits for participants, greater consumer input into study development, and shared and supported decision-making. Older persons' and caregivers' perspectives and experiences of research participation with impaired decision-making capacity require investigation in a greater range of countries and conditions other than dementia, and dissemination through more varied media