The Healthy Aging Brain Care (HABC) Monitor: validation of the Patient Self-Report Version of the clinical tool designed to measure and monitor cognitive, functional, and psychological health

BACKGROUND: Primary care providers need an inexpensive, simple, user-friendly, easily standardized, sensitive to change, and widely available multidomain instrument to measure the cognitive, functional, and psychological symptoms of patients suffering from multiple chronic conditions. We previously validated the Caregiver Report Version of the Healthy Aging Brain Care Monitor (HABC Monitor) for measuring and monitoring the severity of symptoms through caregiver reports. The purpose of this study was to assess the reliability and validity of the Patient Self-Report Version of the HABC Monitor (Self-Report HABC Monitor). DESIGN: Cross-sectional study. SETTING: Primary care clinics affiliated with a safety net urban health care system in Indianapolis, Indiana, USA. SUBJECTS: A total of 291 subjects aged ≥65 years with a mean age of 72.7 (standard deviation 6.2) years, 76% female, and 56% African Americans. ANALYSIS: Psychometric validity and reliability of the Self-Report HABC Monitor. RESULTS: Among 291 patients analyzed, the Self-Report HABC Monitor demonstrated excellent fit for the confirmatory factor analysis model (root mean square error of approximation =0.030, comparative fit index =0.974, weighted root mean square residual =0.837) and good internal consistency (0.78-0.92). Adequate convergent-divergent validity (differences between the Telephone Interview for Cognitive Status test-based cognitive function impairment versus nonimpairment groups) was demonstrated only when patients were removed from analysis if they had both cognitive function test impairment and suspiciously perfect self-report HABC Monitor cognitive floor scores of 0. CONCLUSION: The Self-Report HABC Monitor demonstrates good reliability and validity as a clinically practical multidimensional tool for measuring symptoms. The tool can be used along with its caregiver version to provide useful feedback (via monitoring of symptoms) for modifying care plans. Determining the validity of HABC Monitor scores from patients who self-report a perfect cognitive score of 0 requires cognitive function test results (eg, Telephone Interview for Cognitive Status or Mini Mental State Examination) or Caregiver Report HABC Monitor scores or further clinical examination to rule out the possibility that the patient is denying or unaware of their cognitive symptoms

Human factors in mental healthcare : A work system analysis of a community-based program for older adults with depression and dementia

Mental healthcare is a critical but largely unexplored application domain for human factors/ergonomics. This paper reports on a work system evaluation of a home-based dementia and depression care program for older adults, the Aging Brain Care program. The Workflow Elements Model was used to guide data collection and analysis of 59 h of observation, supplemented by key informant input. We identified four actors, 37 artifacts across seven types, ten action categories, and ten outcomes including improved health and safety. Five themes emerged regarding barriers and facilitators to care delivery in the program: the centrality of relationship building; the use of adaptive workarounds; performance of duplicate work; travel and scheduling challenges; and communication-related factors. Findings offer new insight into how mental healthcare services are delivered in a community-based program and key work-related factors shaping program outcomes

Workforce development to provide person-centered care

OBJECTIVES: Describe the development of a competent workforce committed to providing patient-centered care to persons with dementia and/or depression and their caregivers; to report on qualitative analyses of our workforce's case reports about their experiences; and to present lessons learned about developing and implementing a collaborative care community-based model using our new workforce that we call care coordinator assistants (CCAs). METHOD: Sixteen CCAs were recruited and trained in person-centered care, use of mobile office, electronic medical record system, community resources, and team member support. CCAs wrote case reports quarterly that were analyzed for patient-centered care themes. RESULTS: Qualitative analysis of 73 cases using NVivo software identified six patient-centered care themes: (1) patient familiarity/understanding; (2) patient interest/engagement encouraged; (3) flexibility and continuity of care; (4) caregiver support/engagement; (5) effective utilization/integration of training; and (6) teamwork. Most frequently reported themes were patient familiarity - 91.8% of case reports included reference to patient familiarity, 67.1% included references to teamwork and 61.6% of case reports included the theme flexibility/continuity of care. CCAs made a mean number of 15.7 (SD = 15.6) visits, with most visits for coordination of care services, followed by home visits and phone visits to over 1200 patients in 12 months. DISCUSSION: Person-centered care can be effectively implemented by well-trained CCAs in the community

Care coordinator assistants: Job satisfaction and the importance of teamwork in delivering person-centered dementia care

As the prevalence of persons with dementia increases, a larger, trained, and skilled healthcare workforce is needed. Attention has been given to models of person-centered care as a standard for dementia care. One promising role to deliver person-centered care is the care coordinator assistant. An inquiry about care coordinator assistant’s job satisfaction is reasonable to consider for retention and quality improvement purposes. We evaluated care coordinator assistant’s job satisfaction quantitatively and qualitatively. This study was part of a Centers for Medicare & Medicaid Services Health Care Innovation Award to the Indiana University School of Medicine. Sixteen care coordinator assistants, predominately female, African American or Caucasian, college graduates with a mean age of 43.1 years participated. Care coordinator assistants wrote quarterly case reports to share stories, lessons learned, and/or the impact of their job and completed the revised Job Satisfaction Inventory and Job in General scales during the second year of the Centers for Medicare & Medicaid Services award. For the Job Descriptive Index subscales promotion, supervision, and coworkers and Job in General, care coordinator assistants scored similar to normative means. Care coordinator assistants reported significantly higher satisfaction on the work subscale and significantly lower satisfaction on the pay subscale compared to normative data. Care coordinator assistants completed 119 quarterly case reports. Job satisfaction and teamwork were recurring themes in case reports, referenced in 47.1% and 60.5% of case reports, respectively. To address the demands of increasing dementia diagnoses, care coordinator assistants can constitute a compassionate, competent, and satisfied workforce. Training care coordinator assistants to work together in a team to address the needs of persons with dementia and caregivers provides a viable model of workforce development necessary to meet the growing demands of this population

Training the Workforce to Conduct Embedded Pragmatic Clinical Trials to Improve Care for People Living with Dementia and Their Caregivers

The National Institute on Aging IMbedded Pragmatic Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias Clinical Trials (IMPACT) Collaboratory serves as a national resource for the conduct of embedded pragmatic clinical trials to improve the care of people living with dementia (PLWD) in partnership with the healthcare systems that serve them. Inherent in this objective is the need to train and support a cadre of investigators prepared to conduct this work now and in the future. The Training Core of the IMPACT Collaboratory supports the training of investigators to become experts in this field through three objectives: (1) curricula development and dissemination; (2) network generation and navigation; and (3) a career development award program. The innovative approach of the Training Core will require developing content and providing training experiences that recognize the unique challenges of research at the intersection of health systems, pragmatic trials, and PLWD and their caregivers. Ultimately, we seek to build the nation’s capacity to conduct research that bridges the gaps between efficacy studies to effectiveness research to implementation science. Although foundational resources in the methods of each of these areas are already available, few actually focus on pragmatic trials embedded within healthcare systems that focus on PLWD. To bring new interventions for PLWD from efficacy to widespread implementation, researchers must build diffusability, adaptability, heterogeneity, and scalability into the design of the intervention. In achieving these objectives, the Training Core will utilize the network of investigators, institutions, and stakeholders represented in the IMPACT Collaboratory

Developing the Agile Implementation Playbook for Integrating Evidence-Based Health Care Services into Clinical Practice

Problem: Despite the more than $32 billion the National Institutes of Health has invested annually, evidence-based health care services are not reliably implemented, sustained, or distributed in health care delivery organizations, resulting in suboptimal care and patient harm. New organizational approaches and frameworks that reflect the complex nature of health care systems are needed to achieve this goal. Approach: To guide the implementation of evidence-based health care services at their institution, the authors used a number of behavioral theories and frameworks to develop the Agile Implementation (AI) Playbook, which was finalized in 2015. The AI Playbook leverages these theories in an integrated approach to selecting an evidence-based health care service to meet a specific opportunity, rapidly implementing the service, evaluating its fidelity and impact, and sustaining and scaling up the service across health care delivery organizations. The AI Playbook includes an interconnected eight-step cycle: (1) identify opportunities; (2) identify evidence-based health care services; (3) develop evaluation and termination plans; (4) assemble a team to develop a minimally viable service; (5) perform implementation sprints; (6) monitor implementation performance; (7) monitor whole system performance; and (8) develop a minimally standardized operating procedure. Outcomes: The AI Playbook has helped to improve care and clinical outcomes for intensive care unit survivors and is being used to train clinicians and scientists in AI to be quality improvement advisors. Next Steps: The authors plan to continue disseminating the details of the AI Playbook and illustrating how health care delivery organizations can successfully leverage it

Identification and Validation of Novel Cerebrospinal Fluid Biomarkers for Staging Early Alzheimer's Disease

Ideally, disease modifying therapies for Alzheimer disease (AD) will be applied during the 'preclinical' stage (pathology present with cognition intact) before severe neuronal damage occurs, or upon recognizing very mild cognitive impairment. Developing and judiciously administering such therapies will require biomarker panels to identify early AD pathology, classify disease stage, monitor pathological progression, and predict cognitive decline. To discover such biomarkers, we measured AD-associated changes in the cerebrospinal fluid (CSF) proteome.CSF samples from individuals with mild AD (Clinical Dementia Rating [CDR] 1) (n = 24) and cognitively normal controls (CDR 0) (n = 24) were subjected to two-dimensional difference-in-gel electrophoresis. Within 119 differentially-abundant gel features, mass spectrometry (LC-MS/MS) identified 47 proteins. For validation, eleven proteins were re-evaluated by enzyme-linked immunosorbent assays (ELISA). Six of these assays (NrCAM, YKL-40, chromogranin A, carnosinase I, transthyretin, cystatin C) distinguished CDR 1 and CDR 0 groups and were subsequently applied (with tau, p-tau181 and Aβ42 ELISAs) to a larger independent cohort (n = 292) that included individuals with very mild dementia (CDR 0.5). Receiver-operating characteristic curve analyses using stepwise logistic regression yielded optimal biomarker combinations to distinguish CDR 0 from CDR>0 (tau, YKL-40, NrCAM) and CDR 1 from CDR<1 (tau, chromogranin A, carnosinase I) with areas under the curve of 0.90 (0.85-0.94 95% confidence interval [CI]) and 0.88 (0.81-0.94 CI), respectively.Four novel CSF biomarkers for AD (NrCAM, YKL-40, chromogranin A, carnosinase I) can improve the diagnostic accuracy of Aβ42 and tau. Together, these six markers describe six clinicopathological stages from cognitive normalcy to mild dementia, including stages defined by increased risk of cognitive decline. Such a panel might improve clinical trial efficiency by guiding subject enrollment and monitoring disease progression. Further studies will be required to validate this panel and evaluate its potential for distinguishing AD from other dementing conditions

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population

Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK ‘Alert Level 4’ phase of the B-MaP-C study

Abstract: Background: The B-MaP-C study aimed to determine alterations to breast cancer (BC) management during the peak transmission period of the UK COVID-19 pandemic and the potential impact of these treatment decisions. Methods: This was a national cohort study of patients with early BC undergoing multidisciplinary team (MDT)-guided treatment recommendations during the pandemic, designated ‘standard’ or ‘COVID-altered’, in the preoperative, operative and post-operative setting. Findings: Of 3776 patients (from 64 UK units) in the study, 2246 (59%) had ‘COVID-altered’ management. ‘Bridging’ endocrine therapy was used (n = 951) where theatre capacity was reduced. There was increasing access to COVID-19 low-risk theatres during the study period (59%). In line with national guidance, immediate breast reconstruction was avoided (n = 299). Where adjuvant chemotherapy was omitted (n = 81), the median benefit was only 3% (IQR 2–9%) using ‘NHS Predict’. There was the rapid adoption of new evidence-based hypofractionated radiotherapy (n = 781, from 46 units). Only 14 patients (1%) tested positive for SARS-CoV-2 during their treatment journey. Conclusions: The majority of ‘COVID-altered’ management decisions were largely in line with pre-COVID evidence-based guidelines, implying that breast cancer survival outcomes are unlikely to be negatively impacted by the pandemic. However, in this study, the potential impact of delays to BC presentation or diagnosis remains unknown