Systematic reviews demonstrate that advance care planning (ACP) has many positive effects for residents of aged care facilities, including decreased hospitalisation. The proposed Residential Aged Care Facility (RACF) ‘Goals of Patient Care’ (GOPC) form incorporates a resident’s prior advance care plan into medical treatment orders. Where none exists, it captures residents’ preferences. This documentation helps guide healthcare decisions made at times of acute clinical deterioration. METHODS AND ANALYSIS: This is a mixed methods study. An unblinded cluster randomised controlled trial is proposed in three pairs of RACFs. In the intervention arm, GOPC forms will be completed by a doctor incorporating advance care plans or wishes. In the control arm, residents will have usual care which may include an advance care plan. The primary hypothesis is that the GOPC form is superior to standard ACP alone and will lead to decreased hospitalisation due to clearer documentation of residents’ medical treatment plans. The primary outcome will be an analysis of the effect of the GOPC medical treatment orders on emergency department attendances and hospital admissions at 6 months. Secondary outcome measurements will include change in hospitalisation rates at 3 and 12 months, length of stay and external mortality rates among others. Qualitative interviews, 12 months post GOPC implementation, will be used for process evaluation of the GOPC and to evaluate staff perceptions of the form’s usefulness for improving communication and medical decision-making at a time of deterioration. DISSEMINATION: The results will be disseminated in peer review journals and research conferences. This robust randomised controlled trial will provide high-quality data about the influence of medical treatment orders that incorporate ACP or preferences adding to the current gap in knowledge and evidence in this area.
Calls for Abstracts
CALL FOR ABSTRACTS:
Choosing Wisely Canada National Meeting 2018
This year’s meeting themes are measurement and implementation of the recommendations. We encourage the submission of abstracts on these themes from a variety of perspectives, including medical education, quality improvement, de-prescribing, patient engagement, implementation challenges and successes, and measurement and evaluation. Abstract submissions are welcome from clinicians, students and trainees, healthcare leaders and administrators. Selected abstracts will be presented as oral presentations and workshops.
CALL FOR ABSTRACTS:
KT Canada Scientific Meeting 2018
The theme will be “Advancing the methods of patient-oriented knowledge translation research”.
Grants & Awards
The purpose of this funding opportunity is to support knowledge syntheses and scoping reviews, which are the cornerstone of knowledge translation. They transform vast libraries of scientific literature into knowledge that is reliable, relevant and readable for knowledge users.
Individuals from any discipline are encouraged to apply, so long as their proposed summer activities align with the strategic priorities of CFN related to improving care for older Canadians living with frailty. Fellowships begin September 1, 2018. The number of fellowships will be determined by the quality of the applicants and the number of applicants received per fellowship level.
The competition is open to students enrolled full-time in an undergraduate degree program at an eligible Canadian university who have completed at least two full academic terms at the time of application. Students from any discipline are encouraged to apply, so long as their proposed summer activities align with the strategic priorities of CFN related to improving care for older Canadians living with frailty.
Comparative analysis of system scalable programmatic innovations in health care delivery involves the assessment of innovations in care delivery that may include any or all of changes in health care delivery models aimed at improving care delivery models for complex high system users such as: new services, change in health professional or provider roles, integrated service delivery approaches, new funding models, etc.
The GFC University Teaching Awards Committee (UTAC) invites nominations for the following 2018 Awards for Teaching Excellence:
Award for Excellence in Graduate Teaching
Provost’s Award for Early Achievement of Excellence in Undergraduate Teaching
Rutherford Award for Excellence in Undergraduate Teaching
Teaching Unit Award
William Hardy Alexander Award for Excellence in Undergraduate Teaching
The Society for Teaching and Learning in Higher Education (STLHE) and Desire2Learn (D2L) invite submissions for the 2018 D2L Innovation Award in Teaching and Learning. This award (up to five per year) recognizes innovative approaches that promote student-centered teaching and learning. The award is open to instructors who are currently teaching at a post-secondary institution, regardless of discipline, level, or term of appointment.
A range of evidence informs decision-making on innovation in health care, including formal research findings, local data and professional opinion. However, cultural and organisational factors often prevent the translation of evidence for innovations into practice. In addition to the characteristics of evidence, it is known that processes at the individual level influence its impact on decision-making. Less is known about the ways in which processes at the professional, organisational and local system level shape evidence use and its role in decisions to adopt innovations. METHODS: A systematic scoping review was used to review the health literature on innovations within acute and primary care and map processes at the professional, organisational and local system levels which influence how evidence informs decision-making on innovation. Stakeholder feedback on the themes identified was collected via focus groups to test and develop the findings. RESULTS: Following database and manual searches, 31 studies reporting primary qualitative data met the inclusion criteria: 24 were of sufficient methodological quality to be included in the thematic analysis. Evidence use in decision-making on innovation is influenced by multi-level processes (professional, organisational, local system) and interactions across these levels. Preferences for evidence vary by professional group and health service setting. Organisations can shape professional behaviour by requiring particular forms of evidence to inform decision-making. Pan-regional organisations shape innovation decision-making at lower levels. Political processes at all levels shape the selection and use of evidence in decision-making. CONCLUSIONS: The synthesis of results from primary qualitative studies found that evidence use in decision-making on innovation is influenced by processes at multiple levels. Interactions between different levels shape evidence use in decision-making (e.g. professional groups and organisations can use local systems to validate evidence and legitimise innovations, while local systems can tailor or frame evidence to influence activity at lower levels). Organisational leaders need to consider whether the environment in which decisions are made values diverse evidence and stakeholder perspectives. Further qualitative research on decision-making practices that highlights how and why different types of evidence come to count during decisions, and tracks the political aspects of decisions about innovation, is needed.
Health care leaders are responsible for oversight of multiple and competing change interventions. These interventions regularly fail to achieve the desired outcomes and/or sustainable results. This often occurs because of the mental models and approaches that are used to plan, design, implement, and evaluate the system. These do not account for inherent characteristics that determine the system’s likely ability to innovate while maintaining operational effectiveness. Theories exist on how to assess a system’s readiness to change, but the definitions, constructs, and assessments are diverse and often look at facets of systems in isolation. The Systems Transformation Framework prescriptively defines and characterizes system domains on the basis of complex adaptive systems theory so that domains can be assessed in tandem. As a result, strengths and challenges to implementation are recognized before implementation begins. The Systems Transformation Framework defines 8 major domains: vision, leadership, organizational culture, organizational behavior, organizational structure, performance measurements, internal learning, and external learning. Each domain has principles that are critical for creating the conditions that lead to successful organizational adaptation and change. The Systems Transformation Framework can serve as a guide for health care leaders at all levels of the organization to (1) create environments that are change ready and (2) plan, design, implement, and evaluate change within complex adaptive systems.
While there has been continued growth in family nursing knowledge, the complex process of implementing and sustaining family nursing in health care settings continues to be a challenge for family nursing researchers and clinicians alike. Developing knowledge and skills about how to translate family nursing theory to practice settings is a global priority to make family nursing more visible. There is a critical need for more research methods and research evidence about how to best move family nursing knowledge into action. Enhancing health care practice is a multifactorial process that calls for a systemic perspective to ensure its efficacy and sustainability. This article presents insights derived from lessons learned through recent research experiences of using a knowledge translation model to promote practice changes in health care settings.
Policymaking decisions are often uninformed by research and research is rarely influenced by policymakers. To bridge this ‘know-do’ gap, a boundary-spanning knowledge mobilisation (KM) team was created by embedding researchers-in-residence and local policymakers into each other’s organisations. Through increasing the two-way flow of knowledge via social contact, KM team members fostered collaborations and the sharing of ‘mindlines’, aiming to generate more relevant research bids and research-informed decision-making. This paper describes the activities of the KM team, types of knowledge and how that knowledge was exchanged to influence mindlines. Discussion: KM team activities were classified into: relational, dissemination, transferable skills, evaluation, research and awareness raising. Knowledge available included: profession-specific (for example, research methods, healthcare landscape), insider (for example, relational, organisation and experiential) and KM theory and practice. KM team members brokered relationships through conversations interweaving different types of knowledge, particularly organisational and relational. Academics were interested in policymakers’ knowledge of healthcare policy and the commissioning landscape. More than research results, policymakers valued researchers’ methodological knowledge. Both groups appreciated each other as ‘critical friends’. Conclusion: To increase research impact, ‘expertise into practice’ could be leveraged, specifically researchers’ critical thinking and research methodology skills. As policymakers’ expertise into practice also bridges the know-do gap, future impact models could focus less on evidence into practice and more on fostering this mutual flow of expertise. Embedded knowledge brokers from the two communities working in teams can influence the mindlines of both. These ambassadors can create improvements in ‘inter-cultural competence’ to draw academia and policymaking closer.
Partnerships in public health form an important component of commissioning and implementing services, in England and internationally. In this research, we examine the views of staff involved in a City-wide health improvement programme which ran from 2009 to 2013 in England. We examine the practicalities of partnership work in community settings, and we describe some of barriers faced when implementing a large, multi-organisation health improvement programme. METHODS: Qualitative, semi-structured interviews were performed. Purposive sampling was used to identify potential participants in the programme: programme board of directors, programme and project managers and intervention managers. Interviews were conducted one-to-one. We conducted a thematic analysis using the ‘one sheet of paper’ technique. This involved analysing data deductively, moving from initial to axial coding, developing categories and then identifying emerging themes. RESULTS: Fifteen interviews were completed. Three themes were identified. The first theme reflects how poor communication approaches hindered the ability of partnerships to deliver their aims and objectives in a range of ways and for a range of reasons. Our second theme reflects how a lack of appropriate knowledge exchange hindered decision-making, affected trust and contributed to protectionist approaches to working. This lack of shared, and communicated, understanding of what type of knowledge is most appropriate and in which circumstance made meaningful knowledge exchange challenging for decision-making and partnership-working in the City-wide health improvement programme. Theme three demonstrates how perceptions about silos in partnership-working could be problematic, but silos themselves were at times beneficial to partnerships. This revealed a mismatch between rhetoric and a realistic understanding of what components of the programme were functional and which were more hindrance than help. DISCUSSION: There were high expectations placed on the concept of what partnership work was, or how it should be done. We found our themes to be interdependent, and reflective of the ‘dynamic fluid process’ discussed within the knowledge mobilisation literature. We contend that reframing normal and embedded processes of silos and silo-working already in use might ease resistance to some knowledge exchange processes and contribute to better long-term functioning of public health partnerships.
Few measures of research use in health policymaking are available, and the reliability of such measures has yet to be evaluated. A new measure called the Staff Assessment of Engagement with Evidence (SAGE) incorporates an interview that explores policymakers’ research use within discrete policy documents and a scoring tool that quantifies the extent of policymakers’ research use based on the interview transcript and analysis of the policy document itself. We aimed to conduct a preliminary investigation of the usability, sensitivity, and reliability of the scoring tool in measuring research use by policymakers. METHODS: Nine experts in health policy research and two independent coders were recruited. Each expert used the scoring tool to rate a random selection of 20 interview transcripts, and each independent coder rated 60 transcripts. The distribution of scores among experts was examined, and then, interrater reliability was tested within and between the experts and independent coders. Average- and single-measure reliability coefficients were computed for each SAGE subscales. RESULTS: Experts’ scores ranged from the limited to extensive scoring bracket for all subscales. Experts as a group also exhibited at least a fair level of interrater agreement across all subscales. Single-measure reliability was at least fair except for three subscales: Relevance Appraisal, Conceptual Use, and Instrumental Use. Average- and single-measure reliability among independent coders was good to excellent for all subscales. Finally, reliability between experts and independent coders was fair to excellent for all subscales. CONCLUSIONS: Among experts, the scoring tool was comprehensible, usable, and sensitive to discriminate between documents with varying degrees of research use. Secondly, the scoring tool yielded scores with good reliability among the independent coders. There was greater variability among experts, although as a group, the tool was fairly reliable. The alignment between experts’ and independent coders’ ratings indicates that the independent coders were scoring in a manner comparable to health policy research experts. If the present findings are replicated in a larger sample, end users (e.g. policy agency staff) could potentially be trained to use SAGE to reliably score research use within their agencies, which would provide a cost-effective and time-efficient approach to utilising this measure in practice.
Better use of research evidence (one form of “knowledge”) in health systems requires partnerships between researchers and those who contend with the real-world needs and constraints of health systems. Community-based participatory research (CBPR) and integrated knowledge translation (IKT) are research approaches that emphasize the importance of creating partnerships between researchers and the people for whom the research is ultimately meant to be of use (“knowledge users”). There exist poor understandings of the ways in which these approaches converge and diverge. Better understanding of the similarities and differences between CBPR and IKT will enable researchers to use these approaches appropriately and to leverage best practices and knowledge from each. The co-creation of knowledge conveys promise of significant social impacts, and further understandings of how to engage and involve knowledge users in research are needed. MAIN TEXT: We examine the histories and traditions of CBPR and IKT, as well as their points of convergence and divergence. We critically evaluate the ways in which both have the potential to contribute to the development and integration of knowledge in health systems. As distinct research traditions, the underlying drivers and rationale for CBPR and IKT have similarities and differences across the areas of motivation, social location, and ethics; nevertheless, the practices of CBPR and IKT converge upon a common aim: the co-creation of knowledge that is the result of knowledge user and researcher expertise. We argue that while CBPR and IKT both have the potential to contribute evidence to implementation science and practices for collaborative research, clarity for the purpose of the research-social change or application-is a critical feature in the selection of an appropriate collaborative approach to build knowledge. CONCLUSION: CBPR and IKT bring distinct strengths to a common aim: to foster democratic processes in the co-creation of knowledge. As research approaches, they create opportunities to challenge assumptions about for whom, how, and what is defined as knowledge, and to develop and integrate research findings into health systems. When used appropriately, CBPR and IKT both have the potential to contribute to and advance implementation science about the conduct of collaborative health systems research.
Objectives: To develop a framework for understanding the evidence needs of health systems to inform the AHRQ EPC Program future efforts. We identified several domains to facilitate interaction between health systems and evidence synthesis producers. Successful engagement will require specifying the type of decision or question of the health system; type of evidence synthesis to best address the question(s) of interest; tools to promote the use of evidence; and a feedback or auditing mechanism to determine the impact of evidence integration into health system decisions. Both the trustworthiness of the evidence synthesis process and communication of the trustworthiness of the evidence are additional key domains. Partnerships with health systems are critical for understanding their evidence needs and establishing trust.
Health Care Administration and Organization
Physician burnout is a critical factor influencing the quality of care delivered in various healthcare settings. Although the prevalence and consequences of burnout have been well documented for physicians in various jurisdictions, no studies to date have reported on burnout in the postacute and long-term care setting. In this exploratory study, we sought to quantify the prevalence of burnout among 3 cohorts of physicians, each practicing in nursing homes in the United States (US), Canada, or The Netherlands. International comparisons were solicited to highlight cultural and health system factors potentially impacting burnout levels. Using standard survey techniques, a total of 721 physicians were solicited to participate (Canada 393; US 110; The Netherlands 218). Physicians agreeing to participate were asked to complete the “Maslach Burnout Inventory” using the Survey Monkey platform. A total of 118 surveys were completed from The Netherlands, 59 from Canada, and 65 from the US for response rates of 54%, 15%, and 59%, respectively. While US physicians demonstrated more negative scores in the emotional exhaustion subscale compared with their counterparts in Canada and The Netherlands, there were no meaningful differences on the depersonalization and personal accomplishments subscales. Factors explaining these differences are explored as well as approaches to future research on physician burnout in postacute and long-term care.
To explore global changes in the prescription of analgesic drugs over time in the international long-term care (LTC) population. DESIGN: Systematic review. SETTING: We included original research articles in English, published and unpublished, that included number of participants, country and year(s) of data collection, and prescription of analgesics (analgesics not otherwise specified, opioids, acetaminophen; scheduled only, or scheduled plus as needed (PRN)). PARTICIPANTS: LTC residents. MEASUREMENTS: We searched PubMed, EMBASE, CINAHL, International Pharmaceutical Abstracts, PsycINFO, Cochrane, Web of Science, Google Scholar, using keywords for LTC facilities and analgesic medication; hand-searched references of eligible papers; correspondence. Studies were quality rated using an adapted Newcastle-Ottawa scale. Pearson correlation coefficients were generated between percentage of residents prescribed an analgesic and year of data collection. If available, we investigated changes in acetaminophen and opioid prescriptions. RESULTS: Forty studies met inclusion criteria. A moderate correlation (0.59) suggested that scheduled prescription rates for analgesics have increased over time. Similar findings were reflected in scheduled prescriptions for acetaminophen and opioids. No increase was seen when analyzing scheduled plus PRN analgesics. Use of opioids (scheduled plus PRN) appears to have increased over time. CONCLUSION: Worldwide, use of opioids and acetaminophen has increased in LTC residents. Research is needed to explore whether this reflects appropriate pain management for LTC residents and if PRN medication is used effectively.
The goal of this study was to examine current rates of resident deaths, Emergency Department (ED) use within the last year of life, and hospital deaths for long-term care (LTC) residents. Using a mixed-methods approach, we compared these rates across four LTC homes in Ontario, Canada, and explored potential explanations of variations across homes to stimulate staff reflections and improve performance based on a quality improvement approach. Chart audits revealed that 59% of residents across sites visited EDs during the last month of life and 26% of resident deaths occurred in hospital. Staff expressed surprise at the amount of hospital use during end of life (EOL). Reflections suggested that clinical expertise, comfort with EOL communication, clinical resources (i.e., equipment), and family availability for EOL decision making could all affect nondesirable hospital transfers at EOL. Staff appeared motivated to address these areas of practice following this reflective process.
OBJECTIVE: To estimate the additional societal costs for people living with dementia (PwD) with agitation in home care (HC) and institutional long-term care (ILTC) settings in 8 European countries. DESIGN: Cross-sectional data from the RightTimePlaceCare cohort. SETTING: HC and ILTC settings from 8 European countries (Estonia, Finland, France, Germany, Netherlands, Spain, Sweden, and England). PARTICIPANTS: A total of 1997 PwD (1217 in HC group and 780 lived in an ILTC) and their caregivers. MAIN OUTCOME MEASURES: Medical care, community care, and informal care were recorded using the Resource Utilization in Dementia (RUD) questionnaire. Agitation was assessed based on the agitation symptoms cluster defined by the presence of agitation and/or irritability and/or disinhibition and/or aberrant motor behavior items of the Neuropsychiatric Inventory Questionnaire (NPI-Q). RESULTS: Total monthly mean cost differences due to agitation were 445euro in the HC setting and 561euro in the ILTC setting (P = .01 and .02, respectively). Informal care costs were the main driver in the HC group (73% of total costs) and institutional care costs were the main driver in the ILTC group (53% of total costs). After adjustments, the log link generalized linear mixed model showed an association between agitation symptoms and an increase of informal care costs by 17% per month in HC setting (P < .05). CONCLUSION: This study found that agitation symptoms have a substantial impact on informal care costs in the community care setting. Future research is needed to evaluate which strategies may be efficient by improving the cost-effectiveness ratio and reducing the burden associated with informal care in the management of agitation in PwD.
This study explores staff responses, in terms of common practices, toward partnered sexual relationships in long-term care facilities where one or both people involved have dementia. It also tries to determine personal and institutional factors influencing these responses. BACKGROUND: Although some studies, mostly qualitative, have focused on reactions to residents’ sexual expressions so far the issue has not been assessed in a study using large and diverse samples. DESIGN: Cross-sectional quantitative study using vignette technique. METHODS: Participants were 2,295 staff members at 152 Spanish long-term care facilities. Data were collected during 2016. A vignette describing sexual situations involving people with dementia was presented to participants. After the vignette, participants had to answer the question ‘What do you think most of your colleagues would do in this situation?’ with nine possible responses. RESULTS: Results showed that relationships involving persons with dementia were perceived as potentially problematic by staff. In both conditions, discussing the case with a colleague or supervisor was the most frequently chosen reaction. More restrictive reactions were mentioned when only one person with dementia was involved in the relationship. Factors such as participants’ age and years of experience, professional post and commitment to person-centered care practices were related with the frequency of common restriction practices. CONCLUSION: Results highlight the importance of providing staff with clear guidelines regarding the management of specific sexual situations to avoid stereotyped restrictive reactions.
There has been much recent discussion internationally about the emergence in modern society of a new class of workers – the precariat – with a common consciousness based on features such as low wages, insecurity, short-term jobs, minority status and restricted rights. This paper critically explores the extent to which the growing, large-scale group of personal support workers (PSWs) can be viewed as part of a new precariat in terms of their position in the healthcare labour market. Drawing on currently available empirical data, this issue is examined particularly with reference to PSWs in Canada – drawing out some of the implications for government health policy in this sphere.
Building palliative care (PC) capacity in nursing homes (NH) is a national priority and essential to providing high quality care for residents with advanced illness. We report on NH staff experiences in developing and sustaining Palliative Care Teams (PCTeams) as part of a randomized clinical trial to â€œImprove Palliative Care through Teamworkâ€ (IMPACTT).Research Design and MethodsWe conducted rapid ethnographic assessments of all NH (N = 14) in the intervention arm. Data included semistructured interviews with direct care and administrative staff (n = 41), field observations, and written materials. We used a phased approach to data analysis including open coding and comparative analyses within and across homes.ResultsWe found four key structural themes in our analysis including: administrative support, financial considerations, turnover and staffing, and competing priorities. The development and sustainability of the nascent PCTeams were constantly threatened by competing priorities and the key factor in their success was consistent and tangible administrative support.Discussion and ImplicationsWhile improving PC in NHs is a recognized priority, lack of stable infrastructure and unintended consequences of reimbursement policies created conditions which often thwarted the sustainability of the PCTeams.
Health Care Innovation and Quality Assurance
Despite the passage of OBRA’87 for nursing home reform, concerns about care in facilities continue. The Centers for Medicare and Medicaid developed new regulations and the Traditional Survey (TS) process for annual nursing home survey. The survey is conducted by state regional offices to determine facility compliance with federal regulations. Despite the regulations and new survey process, the TS inconsistently identified problems. A computerized process called the Quality Indicator Survey (QIS) was subsequently developed. This study was designed to compare results from TS and QIS on overall deficiencies, select quality indicators, high-severity deficiencies, and severity differences of seven quality indicators in New York State over a 6-year period from 2010 through 2015. Results of t-tests determined a significant difference in the overall mean number of deficiencies (p < .001), and on four indicators: choices (p < .001), nursing staff (p < .001), dental (p < .001), and dignity (p < .05). Facilities using the TS showed a higher mean number of harm level or higher deficiencies (p < .001). Chi-square tests for severity levels showed significantly more higher severity deficiencies on two quality indicators: nutrition (p < 0.001) and hydration (p < 0.05). Thus, the QIS produced a greater mean number of deficiencies, while TS produced more higher severity deficiencies in New York State.
Despite much attention including national initiatives, concerns remain about the approaches to managing behavior symptoms and psychiatric conditions across all settings, including in long-term care settings such as nursing homes and assisted living facilities. One key reason why problems persist is because most efforts to “reform” and “correct” the situation have failed to explore or address root causes and instead have promoted inadequate piecemeal “solutions.” Further improvement requires jumping off the bandwagon and rethinking the entire issue, including recognizing and applying key concepts of clinical reasoning and the care delivery process to every situation. The huge negative impact of cognitive biases and rote approaches on related clinical problem solving and decision making and patient outcomes also must be addressed.
Quality improvement projects to address transitions of care across care boundaries are increasingly common but meet with mixed success for reasons that are poorly understood. We aimed to characterise challenges in a project to improve transitions for older people between hospital and care homes. DESIGN: Independent process evaluation, using ethnographic observations and interviews, of a quality improvement project. SETTING AND PARTICIPANTS: An English hospital and two residential care homes for older people. DATA: 32 hours of non-participant observations and 12 semistructured interviews with project members, hospital and care home staff. RESULTS: A hospital-based improvement team sought to reduce unplanned readmissions from residential care homes using interventions including a community-based geriatric team that could be accessed directly by care homes and a communication tool intended to facilitate transfer of information between homes and hospital. Only very modest (if any) impacts of these interventions on readmission rates could be detected. The process evaluation identified multiple challenges in implementing interventions and securing improvement. Many of these arose because of lack of consensus on the nature of the problem and the proper solutions: while the hospital team was keen to reduce readmissions and saw the problems as lying in poor communication and lack of community-based support for care homes, the care home staff had different priorities. Care home staff were unconvinced that the improvement interventions were aligned with their needs or addressed their concerns, resulting in compromised implementation. CONCLUSIONS: Process evaluations have a valuable role in quality improvement. Our study suggests that a key task for quality improvement projects aimed at transitions of care is that of developing a shared view of the problem to be addressed. A more participatory approach could help to surface assumptions, interpretations and interests and could facilitate the coproduction of solutions. This finding is likely to have broader applicability.
Compliant flooring aims to prevent fall-related injuries among high-risk older adults in long-term care, but uptake of compliant flooring in this setting is limited. We hosted a one-day stakeholder symposium to identify advantages and disadvantages of implementing compliant flooring in long-term care and the most pressing directions for future research from the perspective of key stakeholders. Twenty-three stakeholders representing health care, industry, and research attended the symposium. Attendees believed the most important advantages of compliant flooring were reducing injuries in residents who have fallen, potential benefits to care staff, and potential increases in quality of life for residents. Attendees perceived the most significant disadvantages of compliant flooring were financial considerations, lack of research evidence, and challenges with installation. Attendees indicated a need for additional research on cost-effectiveness and clinical effectiveness. While stakeholders perceived compliant flooring to add value to long-term care, there are significant informational and financial barriers to uptake.
Fidelity is the degree to which a change is implemented as intended. Improvement project teams should measure fidelity, because if the change is not implemented, nothing will change. However, measurement resources are usually limited, especially in the early stages of implementation. A frequent problem in quality improvement is that people waste time collecting too much data. A previous paper showed how to demonstrate local gaps in care with very small samples of 5–10 patients. In evaluative clinical trials, the goal is to detect small differences between groups with precise estimates of these differences.
The purpose of the current study was to identify initial effects of a coaching training intervention using Level of Assistance (LoA) strategies compared with traditional lecture techniques on the appropriateness of LoA use by certified nursing assistants (CNAs) and independence of dressing of nursing home residents with dementia. Seventeen CNA-resident dyads participated in this pilot randomized controlled trial (RCT). Control and experimental group CNAs received a 25-minute traditional lecture. Experimental group CNAs also underwent three coaching sessions over 4 weeks. There were significant between-group differences in the percentage of dyads who had improved scores for appropriateness of LoA use and dressing independence from pretest to posttest (experimental: n = 9, 100%; control: n = 8, 50%; p = 0.029). However, there were no statistically significant median differences between groups in appropriateness of LoA use by CNAs and resident dressing independence scores. There were significant within-group median improvements in appropriateness of LoA use (p = 0.004) and independence of dressing scores (p = 0.004) between pretest and posttest in the experimental group, but not in the control group. This initial pilot RCT supports coach training as a method to improve appropriate use of LoA strategies by CNAs and independence of resident dressing.
The project aimed to develop a unit level quality measurement and improvement programme using evidence based fundamentals of care. BACKGROUND: Feedback from patients, families, whanau, staff, and audit data in 2014 indicated variability in the delivery of fundamental aspects of care such as monitoring, nutrition, pain management and environmental cleanliness at a New Zealand District Health Board. DESIGN: A general inductive approach was used to explore the fundamentals of care and design a measurement and improvement programme, the Patient and Whanau Centred Care Standards (PWCCS), focused on fundamental care. METHODS: Five phases were used to explore the evidence, and design and test a measurement and improvement framework. RESULTS: Nine identified fundamental elements of care were used to define expected standards of care and develop and test a measurement and improvement framework. Four six-monthly peer reviews have been undertaken since June 2015. Charge Nurse Managers used results to identify quality improvements. Significant improvement was demonstrated overall, in six of the 27 units, in seven of the nine standards and three of the four measures. In all, 89% (n=24) of units improved their overall result. CONCLUSION: The PWCCS measurement and improvement framework makes visible nursing fundamentals of care in line with continuous quality improvement to increase quality of care
Research Practice and Methodology
While the efficacy of peer review for allocating institutional funding and benchmarking is often studied, not much is known about issues faced in peer review for organizational learning and advisory purposes. We build on this concern by analyzing the largely formative evaluation by external committees of new large, ‘translational’ research programs in a University Medical Center in the Netherlands. By drawing on insights from studies which report problems associated with evaluating and monitoring large, complex, research programs, we report on the following tensions that emerged in our analysis: (1) the provision of self-evaluation information to committees and (2) the selection of appropriate committee members. Our article provides a timely insight into challenges facing organizational evaluations in public research systems where pushes toward ‘social’ accountability criteria and large cross-disciplinary research structures are intensifying. We end with suggestions about how the procedure might be improved.
Women and racial/ethnic minority dementia caregivers have unique caregiving experiences and support needs. To ensure the identification of potentially important differences in outcomes within these groups, the amended National Institutes of Health (NIH) Policy on Inclusion of Women and Minorities mandates reporting by gender and race/ethnicity. The objective of this study was to determine the inclusion and reporting rates among NIH-funded dementia caregiver support interventions. A focused systematic literature review of studies published from 1994 to 2015 located 48 articles meeting inclusion criteria. The majority of studies included women and racial/ethnic minorities; however, 67% did not report results by gender or racial/ethnic group. Acknowledgment of underreporting was more common for race/ethnicity than gender. Our findings suggest limited NIH guideline compliance that may reflect a lack of awareness regarding potential gender disparities in caregiving roles. Ensuring NIH guideline compliance necessitates shared investments from researchers, editors, and reviewers to ensure group differences are systematically identified and reported.
The trend toward increasingly collaborative research involving multiple investigators and research groups has been referred to as group science, ensemble science, or more commonly, team science.1 How authors and nonauthor collaborators can be identified in publications to ensure appropriate credit and recognition of team science is evolving, can be challenging, and is of great importance to the scientific community and individual investigators.
Background: physical activity is recommended for people living with dementia, but evidence for the positive effects of physical activity is limited by the use of heterogeneous outcomes and measurement tools. This systematic literature review aimed to summarise previously reported outcomes and identify the measurement tools used most frequently in physical activity interventions for people with dementia. Methods: literature searches were conducted in April 2015, on Delphis and Medline. Qualitative, quantitative and mixed methods studies reporting on any type of physical activity, in any setting, across types of dementia, stages of disease progression and published from 2005 onwards were included. A content analysis approach was used to report on the frequency of reported outcomes and measurement tools. Results: the 130 included studies reported on 133 different outcome domains and 267 different measurement tools. ‘Functional abilities and independence’ (n = 69), ‘Global cognitive function’ (n = 65), ‘Balance’ (n = 43), ‘Global behavioural symptoms of dementia’ (n = 42) and ‘Health-related quality of life’ (n = 40) were the most frequently reported outcome domains. ‘Enjoyment’ was the outcome most frequently sought by patients and carers. Conclusion: the need for the development and implementation of a Core Outcome Set has been reinforced. Ahead of the completion of the Core Outcome Set, researchers and clinicians are advised to measure the impact of physical activity interventions on these frequently reported outcome domains.
Objectives: to evaluate the frequency of potentially inappropriate medication (PIM) prescription among older people with dementia (PwD) from eight countries participating in the European study ‘RightTimePlaceCare’, and to evaluate factors and adverse outcomes associated with PIM prescription. Methods: survey of 2,004 PwD including a baseline assessment and follow-up after 3 months. Interviewers gathered data on age, sex, prescription of medication, cognitive status, functional status, comorbidity, setting and admission to hospital, fall-related injuries and mortality in the time between baseline and follow-up. The European Union(7)-PIM list was used to evaluate PIM prescription. Multivariate regression analysis was used to investigate factors and adverse outcomes associated with PIM prescription. Results: overall, 60% of the participants had at least one PIM prescription and 26.4% at least two. The PIM therapeutic subgroups most frequently prescribed were psycholeptics (26% of all PIM prescriptions) and ‘drugs for acid-related disorders’ (21%). PwD who were 80 years and older, lived in institutional long-term care settings, had higher comorbidity and were more functionally impaired were at higher risk of being prescribed two PIM or more. The prescription of two or more PIM was associated with higher chance of suffering from at least one fall-related injury and at least one episode of hospitalisation in the time between baseline and follow-up. Conclusions: PIM use among PwD is frequent and is associated with institutional long-term care, age, advanced morbidity and functional impairment. It also appears to be associated with adverse outcomes. Special attention should be paid to psycholeptics and drugs for acid-related disorders.
Comprehensive Geriatric Assessment (CGA) is now the accepted gold standard for caring for frail older people in hospital. However, there is uncertainty about identifying and targeting suitable recipients and which patients benefit the most. Objectives: our objectives were to describe the key elements, principal measures of outcome and the characteristics of the main beneficiaries of inpatient CGA. Methods: we used the Joanna Briggs Institute umbrella review method. We searched for systematic reviews and meta-analyses describing CGA services for hospital inpatients in the Cochrane Database of Systematic Reviews, Database of Reviews of Effectiveness (DARE), MEDLINE and EMBASE and a range of other sources. Results: we screened 1,010 titles and evaluated 419 abstracts for eligibility, 143 full articles for relevance and included 24 in a final quality and relevance check. Thirteen reviews, reported in 15 papers, were selected for review. The most widely used definition of CGA was: ‘a multidimensional, multidisciplinary process which identifies medical, social and functional needs, and the development of an integrated/co-ordinated care plan to meet those needs’. Key clinical outcomes included mortality, activities of daily living and dependency. The main beneficiaries were people >/=55 years in receipt of acute care. Frailty in CGA recipients and patient related outcomes were not usually reported. Conclusions: we confirm a widely used definition of CGA. Key outcomes are death, disability and institutionalisation. The main beneficiaries in hospital are older people with acute illness. The presence of frailty has not been widely examined as a determinant of CGA outcome.
The terms multimorbidity and frailty are increasingly used in the medical literature to measure the risk profile of an older individual in order to support clinical decisions and design ad hoc interventions. The construct of multimorbidity was initially developed and used in nongeriatric settings. It generates a monodimensional nosological risk profile, grounding its roots in the somewhat inadequate framework of disease. On the other hand, frailty is a geriatric concept that implies a more exhaustive and comprehensive assessment of the individual and his/her environment, facilitating the implementation of multidimensional and tailored interventions. This article aims to promote among geriatricians the use of terms that may better enhance their background and provide more value to their unrivaled expertise in caring for biologically aged persons.
Families of persons with dementia continue to report unmet needs during end of life (EOL). Strategies to improve care and quality of life for persons with dementia include development of clinical practice guidelines (CPGs) and an integrative palliative approach. OBJECTIVES: We aimed to assess palliative care content in dementia CPGs to identify the presence or limitations of recommendations and discussion pertaining to common issues or domains affected by illness as described by the Canadian Hospice Palliative Care Association “Square of Care.” DESIGN: A systematic review of databases and gray literature was conducted for recent CPGs. Guidelines meeting inclusion criteria were evaluated using the Appraisal of Guidelines for Research and Evaluation II instrument. Quality CPGs were analyzed through organizational template analysis using illness domains described by the “Canadian Hospice Palliative Care Association Model.” The study protocol is registered at PROSPERO (CRD 42015025369). RESULTS: Eleven CPGs were selected and analyzed from 3779 citations. Nine guidelines demonstrated the maximum level of content regarding physical, psychological, and social care. Conversely, spiritual care was either absent (three) or minimal (three) in CPGs. Six CPGs did not address loss or grief, and seven CPGs did not address or had minimal content regarding EOL care. CONCLUSIONS: The lack of content surrounding grief represents a gap for this population at high risk for complicated grief and chronic sorrow. Results of this review require attention by CPG developers and researchers to develop evidence-based recommendations surrounding spiritual care, EOL, and grief.
Antibiotic stewardship has been called for across all sites of health care, including nursing homes (NHs). Skin and soft tissue infections (SSTIs) are the third most common indication for antibiotics in the NH, and so should be a focus of stewardship. This study audited medical records to identify signs and symptoms of SSTIs treated with antibiotics in relation to the McGeer criteria for surveillance, the Loeb minimum criteria for antibiotic initiation, and prescribing recommendations of the Infectious Disease Society of America. DESIGN: Cross-sectional study. SETTING: Thirty-one NHs in Southeastern United States. MEASUREMENTS: Chart data from a random sample of 161 antibiotic prescriptions for SSTIs were abstracted. To meet the McGeer criteria, pus was present at a suspected SSTI site, or at least four of the following findings were documented as present at the site: new or worsening warmth, redness, swelling, tenderness, serous drainage, or a constitutional finding. The Loeb minimum criteria for initiating antibiotics included findings of new or increasing purulent drainage at a suspected SSTI site or at least two of the following findings: fever or new or worsening redness, tenderness, warmth, or swelling at the suspected site. Audits also collected the name, route, and duration of the associated antibiotic. Analyses calculated the types of diagnoses and evaluated associations between published criteria and prescribing. RESULTS: Cellulitis, skin/soft tissue injury with infection, and abscess were diagnosed in 37% (N = 59), 18% (N = 29), and 16% (N = 26) of cases, respectively; 27% (N = 43) had less specific diagnoses. The McGeer criteria were met in 25% (N = 40), and the Loeb minimum criteria were met in 48% (N = 77) of cases. Doxycycline was the most frequently prescribed antibiotic. The mean treatment length was 9.6 days (standard deviation, 5.6), and the median length of treatment was 8.5 days (range, 3-45). CONCLUSION: SSTIs are not routinely diagnosed or treated according to recommended standards of care, and prescriptions for systemic antibiotics appear to be frequently initiated without regard to recommended definitions of infection or therapies for the associated diagnoses. These findings indicate that SSTIs present various opportunities to improve antibiotic stewardship.
Art galleries are becoming more inclusive in their activities for those with specific needs. The interdisciplinary team on an inpatient behavioural health unit collaborated with artist-educators at the Art Gallery of Hamilton (Ontario, Canada) to create an arts-based programme. ‘Artful Moments’ involved using a combination of art appreciation and hands-on art making activities and took place on the unit at the hospital and at the art gallery. A pilot study of eight participants and their care partners who attended the programme is presented. The purpose of the study was to determine if ‘Artful Moments’ facilitated positive engagement ‘in the moment’ for persons in the middle-to-late stages of dementia. The perception of the programme’s impact from their care partners’ perspectives, as well as their satisfaction with the programme is also reported. Extensive education of art gallery staff and clinical staff preceded the programming, with each team sharing expertize with the other. Sessions (n = 27) took place about twice per month. Data were collected through systematic structured observations of patient participants during the activities and through surveys of care partners. Persons with dementia maintained interest, though not necessarily pleasure, during art appreciation and art making, rarely became sad or anxious, and never became angry. Generally the care partners felt that participants enjoyed the experience, and often they were surprised by the very positive response of the participants. Successful engagement was attributed to a dementia-friendly environment; supportive communication strategies; and a suitable, well-planned activity.
erson-centered care (PCC), which considers nursing home resident preferences in care delivery, has been linked to important outcomes such as improved quality of life, resident satisfaction with care, and mood and reduced behavioral symptoms for residents with dementia. Delivery of PCC fundamentally relies on knowledge of resident preferences. The Minimum Data Set (MDS) 3.0 Preference Assessment Tool (PAT) is a standardized, abbreviated assessment that facilitates systematic examination of preferences from a population of nursing home residents. However, it is unknown how well the PAT discriminates preferences across residents or items. The purpose of this study was to use MDS 3.0 PAT data to describe (1) overall resident preferences, (2) variation in preferences across items, and (3) variation in preferences across residents. DATA: Data from admission MDS assessments between October 1, 2011 and December 31, 2011 were used for this study. SAMPLE: A nationally representative sample of 244,718 residents over the age of 65 years who were able to complete the resident interview version of preference, cognition, and depression assessments were included. MEASUREMENTS: Importance ratings of 16 daily care and activity preferences were the primary outcome measures. Resident factors including function (MDS Activities of Daily Living-Long Form), depression (Patient Health Questionnaire-9), cognitive impairment (Brief Interview for Mental Status), and sociodemographics (age, race, sex, and marital status) were used as predictors of important preferences. ANALYSIS: Overall preferences were examined using descriptive statistics. Proportional differences tests were used to describe variation across items. Logistic regression was used to describe variation in preferences across residents. RESULTS: The majority of residents rated all 16 preferences important. However, there was variation across items and residents. Involvement of family in care and individualizing daily care and activities were rated important by the largest proportion of residents. Several resident factors including cognitive impairment, depression, sex, and race were significant predictors of preferences. CONCLUSIONS: Findings demonstrate the PAT captures variation in preferences across items and residents. Residents with possible depression and cognitive impairment were less likely to rate preferences important than residents without those conditions. Non-Caucasian and male residents reported some preferences differently than Caucasian and female residents. Additional assessment and care planning may be important for these residents. More research is needed to determine the factors that influence preferences and the ways to incorporate them into care.
As part of the Missouri Quality Initiative (MOQI) to reduce hospitalizations for long-stay nursing home residents, this article describes reasons MOQI advanced practice registered nurses (APRNs) recommended medication order changes as part of their medication review process as well as the outcomes of their recommendations. DESIGN: Cross-sectional descriptive study of MOQI APRN-conducted medication reviews. SETTING: Long-stay nursing homes participating in the MOQI project. PARTICIPANTS: Seventeen MOQI APRNs recorded medication reviews for 3314 long-stay residents residing in 16 Midwestern nursing homes over a 2-year period. INTERVENTION: APRNs conducted medication reviews and made recommendations for medication order changes to residents’ medical providers. MEASUREMENTS: The MOQI medication review database was used to abstract data. RESULTS: There were 19,629 medication reviews recorded for 3314 residents during the 2-year period. Of the 19,629 reviews, 50% (n = 9841) resulted in recommended order changes of which 82% (n = 8037) of order changes occurred. More than two-thirds of recommendations were because of changes in the residents’ plans of care. Other recommendations included adjusting and/or discontinuing medications that had the potential for harm. CONCLUSION: Resident care needs are dynamic, resulting in the need for frequent medication order changes. MOQI APRNs, because of their advanced pharmacological education and daily presence in the nursing home, are uniquely positioned to ensure residents’ medications aligned with their overall goals of care while minimizing risk of harm.
Disability declined in lower levels of impairment during the late 20th century. However, it is unclear whether ADL disability also declined, or whether it did so across race. In this study, we examine cohorts entering later life between 1984 and 1999, by race, to understand changing ADL disability. METHOD: We used latent class methods to model trajectories of ADL disability and subsequent mortality in the National Long-Term Care Survey among cohorts entering older adulthood (ages 65-69) between 1984 and 1999. We examined patterns by race, focusing on chronic condition profiles. RESULTS: White cohorts experienced consistent declines in ADL disability but Blacks saw little improvement with some evidence for increased disability. Stroke, diabetes, and heart attack were predominant in predicting disability among Blacks. DISCUSSION: Declining disability trends were only observed consistently among Whites, suggesting previous and future disability trends and their underlying causes should be examined by race.
To explore inequalities in oral health impact among care home residents using OHIP-14 and ADHS criteria. Basic research design: Cross-sectional survey with structured interview and clinical examination using 2009 ADHS criteria including OHIP-14. Comparisons were made between groups of residents and with findings from the ADHS 2009. Participants: Care homes and residents were randomly selected. Those without capacity and non-English/Welsh speakers were excluded. 447 residents answered all OHIP-14 questions and had full oral examination. Main Outcome Measure: OHIP-14. Results: Reporting of OHIP problems was more common among care home residents compared with older people examined in the ADHS 2009 (50% vs 40%). There was no difference in the mean number of impacts between residents who were: dentate/edentate; denture wearing/non-denture wearing; with/without caries. Residents reporting ‘problems and pain in your mouth at the moment’, or ‘occasional or more frequent dry mouth’, more often experienced OHIP-14 impacts. Conclusion: Compared with peers living in the community, both dentate and edentate care home residents are more likely to live with one or more impacts. Two simple questions related to ‘Any problems and pain in your mouth?’ and ‘Do you have frequent dry mouth?’ may help to target care home residents more likely to experience oral health impacts.
Existing measures designed to assess family involvement in the lives of older adults residing in long-term care facilities are basic, using visitation frequency as the prominent gauge of involvement in a situation specific fashion. The purpose of this study was to design and validate a measure of family involvement that could be used to gauge more aspects of family involvement than visitation alone and be useful in a variety of settings for both researchers and long-term care facility administrators.MethodsLong-term facility staff were asked to assist in creating a 40-item questionnaire that used 4-point Likert scales to measure various aspects of family involvement. The finalized Family Involvement Questionnaire-Long-Term Care (FIQ-LTC) was distributed to the family members of older adults residing in long-term care facilities around the country.ResultsA total of 410 participants responded. Researchers found that the FIQ-LTC was highly reliable (Î± = .965). Results also indicated that a significant correlation between distance and overall involvement (r = âˆ’.121, p = .015) was no longer significant (r = .17, p = .740) when the effect of a question asking the frequency of visitation was controlled for.DiscussionThese results indicate that existing measures that use visitation frequency as the sole measure of involvement are insufficient. The newly developed FIQ-LTC can serve as a more complete measure of family involvement.
KT Canada Summer Institute 2018
The theme will be “Knowledge Translation Interventions”. Applications will open in January. Confirmed speakers:
Dr. Melissa Brouwers, McMaster University
Dr. Heather Colquhoun, University of Toronto
Dr. Janet Curran, Dalhousie University
Dr. Sophie Desroches, Laval University
Dr. David Johnson, University of Calgary
Dr. Monika Kastner, North York General Hospital
Dr. Krystina Lewis, University of Ottawa Heart Institute
Dr. Linda Li, University of British Columbia
Dr. Julia Moore, St. Michael’s Hospital
Dr. Byron Powell, University of North Carolina
For questions please contact Meghan Storey firstname.lastname@example.org
The research team, led by Dr. Holly Tuokko and funded by the Alzheimer Society of Canada and the Pacific Alzheimer Research Foundation, is examining detailed information about the cognitive performance of English and French-speaking participants in the Canadian Longitudinal Study on Aging (CLSA). The researchers are characterizing typical performances of neurologically healthy people on the cognitive measures employed in the CLSA for use as standards when identifying cognitive impairment. They are also developing various easily-accessed, plain language tools (e.g., derived variables, online tools for generating cognitive classification) for use by clinicians and researchers regarding cognitive functioning as measured in the CLSA.
Research Impact Canada is producing this journal club series as a way to make evidence on KMb more accessible to knowledge brokers and to create on line discussion about research on knowledge mobilization. It is designed for knowledge brokers and other knowledge mobilization stakeholders. Read this open access article. Then come back to this post and join the journal club by posting your comments.
Practicing Knowledge Translation (PKT): Implementing evidence. Achieving outcomes is a 5-day course with a pre and post workshop webinar that focuses on applying KT science to inform implementation. The course presents a method of using evidence-based implementation strategies to produce behavior and practice changes and achieve desired outcome
KT Canada Research Operations webinar: the AGREE tool
These webinars are broadcast via Webex. To register, please contact Meghan Storey StoreyM@smh.ca
The NCCMT has developed a Rapid Review Guidebook that details each step in the rapid review process, with notes on how to tailor the process given resource limitations. The Guidebook also includes a guide to writing the final report, with details on how to structure the report and what to include in each section. Join us for an overview of the rapid review process. Participants will learn about the steps of a rapid review and resources required to support the rapid review process.
The goal of the project was to identify differences between two leading frailty tools in their accuracy and ease of use for patients and clinicians. These new discoveries will be provided to clinicians to help them choose which frailty tool to use before surgery to identify older patients at a high-risk of bad outcomes after surgery.
Medical science has failed to prove that any treatment, therapy or brain exercise can help prevent dementias such as Alzheimer’s disease, an extensive new review has concluded.
While rates of mental decline and dementia have dropped among American seniors overall, they remain higher in rural areas than in cities, a new study finds.
It’s widely believed that older age is darkened by persistent loneliness. But a considerable body of research confirms this isn’t the case. In fact, loneliness is the exception rather than the rule in later life. And when it occurs, it can be alleviated: It’s a mutable psychological state.
Because the job title is not protected, anyone can call themselves a nurse. It diminishes the work of the highly trained staff on the NHS frontline.
The world of stakeholder engagement and consultation is an emerging and progressive area of practice. By participating in the North American Stakeholder Engagement and Consultation Practitioners Survey you will help compile a definitive industry report. After the survey closes, results will be compiled into an engaging and easy-to-understand report. This free report will provide insights such as how often are organizations consulting, what tactics and tools they are using, and what they consider to be best practices.
A doctor examining a veteran — a 20-year Air Force mechanic named Walter Savage who had been living alone — decided he was in no shape to care for himself and should be admitted to the hospital. A second doctor running the inpatient ward agreed. But the hospital administration said no.
Language matters: We need a term that aging people can embrace.
More than 200,000 Americans live with younger-onset Alzheimer’s, with symptoms developing in their 40s and 50s. Younger-onset Alzheimer’s can put an unexpected strain on relationships and finances; one couple living with the disease created a podcast to help others cope.
Reporting to the Principal Investigators, the Research Project Manager will be responsible for the overall management of a three-year Canadian Institute of Health Research (CIHR) funded research project about acute low back pain based in a primary care setting. The incumbent will provide leadership and expert level technical advice into the implementation and conduct of the project, including being responsible for the overall project plan and activities, staffing and training, budget development, and financial accountability. The incumbent will establish project priorities, develop training requirements for participating primary care practices, ensure there is active communication with study sites, and promote effective collaboration with the study investigators.