Clinical Outcome Assessments and Digital Health Technologies Supporting Clinical Trial Endpoints in Early Parkinson's Disease: Roundtable Proceedings and Roadmap for Research.

This article summarizes the Parkinson's Disease (PD) Endpoints Roundtable, which was held in Washington, D.C., on November 2-3, 2022, and hosted by The Michael J. Fox Foundation for Parkinson's Research, Parkinson's UK, and Parkinson Canada. This event brought representatives from academia and industry together with those from regulatory agencies, community partners, and research funders to discuss challenges in clinical outcome assessment development for treatments in early PD and to identify priorities for the field and opportunities for collaboration. This article provides a summary of the presentations given and topics discussed at the roundtable and synthesizes the discussions about the development of clinical outcome assessments and the use of digital health technologies for developing clinical trial endpoints.

Patient-reported pain and physical health for acupuncture and chiropractic care delivered by Veterans Affairs versus community providers.

BACKGROUND: Acupuncture and chiropractic care are evidence-based pain management alternatives to opioids. The Veterans Health Administration (VA) provides this care in some VA facilities, but also refers patients to community providers. We aimed to determine if patient-reported outcomes differ for acupuncture and chiropractic care from VA versus community providers. MATERIALS AND METHODS: We conducted an observational study using survey outcome data and electronic medical record utilization data for acupuncture and chiropractic care provided in 18 VA facilities or in community facilities reimbursed by VA. Study participants were users of VA primary care, mental health, pain clinic, complementary and integrative therapies, coaching or education services in 2018-2019. Patients received 1) 4+ acupuncture visits (N = 201) or 4+ chiropractic care visits (N = 178) from a VA or community provider from 60 days prior to baseline to six-months survey and 2) no acupuncture or chiropractic visits from 1 year to 60 days prior to baseline. Outcomes measured included patient-reported pain (PEG) and physical health (PROMIS) at baseline and six-month surveys. Multivariate analyses examined outcomes at six months, adjusting for baseline outcomes and demographics. RESULTS: In unadjusted analyses, pain and physical health improved for patients receiving community-based acupuncture, while VA-based acupuncture patients experienced no change. Unadjusted analyses also showed improvements in physical health, but not pain, for patients receiving VA-based chiropractic care, with no changes for community-based chiropractic care patients. Using multivariate models, VA-based acupuncture was no different from community-based acupuncture for pain (-0.258, p = 0.172) or physical health (0.539, p = 0.399). Similarly, there were no differences between VA- and community-based chiropractic care in pain (-0.273, p = 0.154) or physical health (0.793, p = 0.191). CONCLUSIONS: Acupuncture and chiropractic care were associated with modest improvements at six months, with no meaningful differences between VA and community providers. The choice to receive care from VA or community providers could be based on factors other than quality, like cost or convenience.

Role matters in understanding 'quality' in palliative care: a qualitative analysis of patient, caregiver and practitioner perspectives.

OBJECTIVES: To compare the discussions from two panels on the concept of palliative care quality for patients with advanced cancer, exploring the priorities reflected in each group's perspectives. DESIGN: We convened two RAND-UCLA appropriateness panel discussions on palliative care quality in advanced cancer. Discussions were audio-recorded and transcribed verbatim. Panel transcripts were analysed thematically using a matrix approach to examine perceptions and experiences of quality. SETTING: Discussions were framed within the context of advanced cancer care and palliative care. PARTICIPANTS: The patient-caregiver panel had 9 patients with current or a history of cancer and caregivers, and the practitioner panel had 10 expert practitioners representing fields of oncology, primary care, social work, palliative care, nursing, pain management and ethics. RESULTS: Our analysis identified three thematic categories for understanding quality common across both groups and nine subthemes within those categories. At the highest level, quality was conceived as: (1) the patient and caregiver experience of care, (2) technical competence and (3) the structure of health system. Among the subthemes, four were present in only one of the two group's discussions: 'purpose and action' was specific to the patient-caregiver panel, whereas 'adhering to best medical practice', 'mitigating unintended consequences and side effects', and 'health system resources and costs' were specific to the practitioner panel. CONCLUSIONS: While both panels aligned on the three key domains of quality, the particular dimensions through which they perceived quality varied in relation to their experience and role as a professional provider of care versus recipient of healthcare services. These differences suggest the importance of adopting a collaborative approach to quality measurement and improvement so that the values of all interested parties are represented in improvement efforts.

What Patients Facing Cancer and Caregivers Want From Communication in Times of Crisis: A Qualitative Study in the Early Months of the COVID-19 Pandemic.

BACKGROUND: Interpersonal communication is a cornerstone of patient-centered care. We aimed to identify what patients with cancer and caregivers may want from communication during a public health crisis. METHODS: We interviewed 15 patients (8 Veteran, 7 non-Veteran) and caregivers from regionally, racially, and ethnically diverse backgrounds across the US about serious illness care and quality of care during the COVID-19 pandemic Using an iterative, inductive and deductive process, 2 coders analyzed content associated with the code "Communication," which appeared 71 times, and identified 5 themes. RESULTS: Participants identified as White (10), Latino/a (3), Asian (1), and Black (1). (1) Help patients and caregivers prepare for care during crisis by communicating medical information directly and proactively. (2) Explain how a crisis might influence medical recommendations and impact on recovery from illness. (3) Use key messengers to improve communication between primary teams, patients, and caregivers. (4) Include caregivers and families in communication when they cannot be physically present. (5) Foster bidirectional communication with patients and families to engage them in shared decision-making during a vulnerable time. CONCLUSION: Communication is critical during a public health crisis yet overwhelmed clinicians may not be able to communicate effectively. Communicating with caregivers and family, transparent and timely communication, ensuring diverse providers are on the same page, and effective listening are known gaps even before the COVID-19 pandemic. Clinicians may need quick interventions, like education about goals of care, to remind them about what seriously ill patients and their caregivers want from communication and offer patient-centered care during crises.

Depression care quality among patients with solid tumor cancers detected to have depression in Veterans Health Administration primary care clinics.

Patients with cancer, especially advanced cancer, experience depression at high rates. We aimed to evaluate the quality of depression care received by patients with solid tumor cancer and advanced solid tumor cancer in Veterans Affairs (VA) primary care clinics. This is a retrospective cohort study of patients seen in 82 VA primary care clinics who newly screened positive for depression on the Patient Health Questionnaire (PHQ-2). Outcomes included timely follow-up within 84 or 180 days (3+ mental health specialty, 3+ psychotherapy, or 3+ primary care visits with depression diagnosis codes) and minimum treatment within 1 year (60+ days antidepressants prescribed, 4+ mental health specialty visits, or 3+ psychotherapy visits). 608,042 individuals were seen in VA primary care clinics during this period; 49,839 patients (8.2%) had solid tumor cancer and 9,278 (1.5%) had advanced or poor-prognosis solid tumor cancer. For 686 observations of patients with cancer and new depression, rates of appropriate follow-up were 22.3% within 84 days and 38.2% within 180 days. For 73 observations of patients with advanced or poor-prognosis cancer and new depression, rates of appropriate follow-up were 21.9% within 84 days and 34.3% within 180 days. Rates of minimum treatment within 1 year were 68.4% and 64.4% for patients with cancer and patients with advanced or poor-prognosis cancer, respectively. Quality of timely depression management is low in patients with solid tumor cancers. Even in health systems with well-integrated mental health services, care gaps remain for patients with cancer and depression. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Integrating Patient and Expert Perspectives to Conceptualize High-Quality Palliative Cancer Care for Symptoms in the US Veterans Health Administration: A Qualitative Study.

Quality measurement is typically the domain of clinical experts and health system leaders; patient/caregiver perspectives are rarely solicited. We aimed to describe and integrate clinician and patient/caregiver conceptualizations of high-quality palliative symptom care for patients receiving care for advanced cancer within the US Veterans Health Administration in the context of existing quality measures. We conducted a secondary qualitative analysis of transcripts from prioritization discussions of process quality measures relevant to cancer palliative care. These discussions occurred during 2 modified RAND-UCLA appropriateness panels: a panel of 10 palliative care clinical expert stakeholders (7 physicians, 2 nurses, 1 social worker) and a panel of 9 patients/caregivers with cancer experience. Discussions were recorded, transcribed, and independently double-coded using an a priori logical framework. Content analysis was used to identify subthemes within codes and axial coding was used to identify crosscutting themes. Patients/caregivers and clinical experts contributed important perspectives to 3 crosscutting themes. First, proactive elicitation of symptoms is critical. Patients/caregivers especially emphasized importance of comprehensive and proactive screening and assessment, especially for pain and mental health. Second, screening and assessment alone is not enough; information elicited from patients must inform care. Measuring screening/assessment and management care processes separately has important limitations. Lastly, high-quality symptom management can be broadly defined if it is patient-centered; high-quality care takes an individualized approach and might include non-medical or non-pharmacological symptom management. Integrating the perspectives of clinical experts and patients/caregivers is critical for health systems to consider as they design and implement quality measures for palliative cancer care.

Patient and Caregiver Prioritization of Palliative and End-of-Life Cancer Care Quality Measures.

BACKGROUND: Development and prioritization of quality measures typically relies on experts in clinical medicine, but patients and their caregivers may have different perspectives on quality measurement priorities. OBJECTIVE: To inform priorities for health system implementation of palliative cancer and end-of-life care quality measures by eliciting perspectives of patients and caregivers. DESIGN: Using modified RAND-UCLA Appropriateness Panel methods and materials tailored for knowledgeable lay participants, we convened a panel to rate cancer palliative care process quality measure concepts before and after a 1-day, in-person meeting. PARTICIPANTS: Nine patients and caregivers with experience living with or caring for patients with cancer. MAIN MEASURES: Panelists rated each concept on importance for providing patient- and family-centered care on a nine-point scale and each panelist nominated five highest priority measure concepts ("top 5"). KEY RESULTS: Cancer patient and caregiver panelists rated all measure concepts presented as highly important to patient- and family- centered care (median rating ≥ 7) in pre-panel (mean rating range, 6.9-8.8) and post-panel ratings (mean rating range, 7.2-8.9). Forced choice nominations of the "top 5" helped distinguish similarly rated measure concepts. Measure concepts nominated into the "top 5" by three or more panelists included two measure concepts of communication (goals of care discussions and discussion of prognosis), one measure concept on providing comprehensive assessments of patients, and three on symptoms including pain management plans, improvement in pain, and depression management plans. Patients and caregivers nominated one additional measure concept (pain screening) back into consideration, bringing the total number of measure concepts under consideration to 21. CONCLUSIONS: Input from cancer patients and caregivers helped identify quality measurement priorities for health system implementation. Forced choice nominations were useful to discriminate concepts with the highest perceived importance. Our approach serves as a model for incorporating patient and caregiver priorities in quality measure development and implementation.

Comparing Post-Acute Populations and Care in Veterans Affairs and Community Nursing Homes.

OBJECTIVE: The quality of care provided by the US Department of Veterans Affairs (VA) is increasingly being compared to community providers. The objective of this study was to compare the VA Community Living Centers (CLCs) to nursing homes in the community (NHs) in terms of characteristics of their post-acute populations and performance on 3 claims-based ("short-stay") quality measures. DESIGN: Observational, cross-sectional. SETTING AND PARTICIPANTS: CLC and NH residents admitted from hospitals during July 2015-June 2016. METHODS: CLC residents were compared with 3 NH populations: males, Veterans, and all NH residents. CLC and NH performance was compared on risk-adjusted claims-based measures: unplanned rehospitalizations and emergency department visits within 30 days of CLC or NH admission and successful discharge to the community within 100 days of NH admission. RESULTS: Veterans admitted from hospitals to CLCs (n = 23,839 Veterans/135 CLCs) were less physically impaired, less likely to have anxiety, congestive heart failure, hypertension, and dementia than Veterans (n = 241,177/14,818 NHs), males (n = 661,872/15,280 NHs), and all residents (n = 1,674,578/15,395 NHs) admitted to NHs from hospitals. Emergency department and successful discharge risk-adjusted rates of CLCs were statistically significantly better than those of NHs [mean (standard deviation): 8.3% (4.6%) and 67.7% (11.5%) in CLCs vs 11.9% (5.3%) and 57.0% (10.5%) in NHs, respectively]. CLCs had slightly worse rehospitalization rates [22.5% (6.2%) in CLCs vs 21.1% (5.9%) in NHs], but lower combined emergency department and rehospitalization rates [30.8% (0.8%) in CLCs vs 33.0% (0.7%) in NHs]. CONCLUSIONS AND IMPLICATIONS: CLCs and NHs serve different post-acute care populations. Using the same risk-adjusted NH quality metrics, CLCs provided better post-acute care than community NHs.

Expert Stakeholder Prioritization of Process Quality Measures to Achieve Patient- and Family-Centered Palliative and End-of-Life Cancer Care.

Importance: Quality measures of palliative and end-of-life care relevant to patients with advanced cancer have been developed, but few are in routine use. It is unclear which of these measures are most important for providing patient- and family-centered care and have high potential for improving quality of care. Objective: To prioritize process quality measures for assessing delivery of patient- and family-centered palliative and end-of-life cancer care in US Veterans Affairs (VA) health care facilities. Design, Setting, Participants: A panel of 10 palliative and cancer care expert stakeholders (7 physicians, 2 nurses, 1 social worker) rated process quality measure concepts before and after a 1-day meeting. Measures: Panelists rated 64 measure concepts on a nine-point scale on: (1) importance to providing patient- and family-centered care, and (2) potential for quality improvement (QI). Panelists also nominated five highest priority measure concepts ("top 5") on each attribute. Results: Panelists rated most measure concepts (54 premeeting, 56 post-meeting) as highly important to patient- and family-centered care (median rating ≥7). Considerably fewer (17 premeeting, 22 post-meeting) were rated as having high potential for QI. Measure concepts having postpanel median ratings ≥7 and nominated by one or more panelists as "top 5" on either attribute comprised a shortlist of 20 measure concepts. Conclusions: A panel of expert stakeholders helped prioritize 64 measure concepts into a shortlist of 20. Half of the shortlisted measures were related to communication about patient preferences and decision making, and half were related to symptom assessment and treatment.

Measure Scan and Synthesis of Palliative and End-of-Life Process Quality Measures for Advanced Cancer.

PURPOSE: Monitoring and improving the quality of palliative and end-of-life cancer care remain pressing needs in the United States. Among existing measures that assess the quality of palliative and end-of-life care, many operationalize similar concepts. We identified existing palliative care process measures and synthesized these measures to aid stakeholder prioritization that will facilitate health system implementation in patients with advanced cancer. METHODS: We reviewed MEDLINE/PubMed-indexed articles for process quality measures related to palliative and end-of-life care for patients with advanced cancer, supplemented by expert input. Measures were inductively grouped into "measure concepts" and higher-level groups. RESULTS: Literature review identified 226 unique measures from 23 measure sources, which we grouped into 64 measure concepts within 12 groups. Groups were advance care planning (11 measure concepts), pain (7), dyspnea (9), palliative care-specific issues (6), other specific symptoms (17), comprehensive assessment (2), symptom assessment (1), hospice/palliative care referral (1), spiritual care (2), mental health (5), information provision (2), and culturally appropriate care (1). CONCLUSION: Measure concepts covered the spectrum of care from acute symptom management to advance care planning and psychosocial needs, with variability in the number of measure concepts per group. This taxonomy of process quality measure concepts can be used by health systems seeking stakeholder input to prioritize targets for improving palliative and end-of-life care quality in patients with advanced cancer.

Impacts of Health Care Industry Consolidation in Pittsburgh, Pennsylvania: A Qualitative Study.

While most studies of health care industry consolidation focus on impacts on prices or quality, these are not its only potential impacts. This exploratory qualitative study describes industry and community stakeholder perceptions of the impacts of cumulative hospital, practice, and insurance mergers, acquisitions, and affiliations in Pittsburgh, Pennsylvania. Since the 1980s, Pittsburgh's health care landscape has been transformed and is now dominated by competition between 2 integrated payer-provider networks, health care system UPMC (and its insurance arm UPMC Health Plan) and insurer Highmark (and its health care system Allegheny Health Network). Semi-structured interviews with 20 boundary-spanning stakeholders revealed a mix of perceived impacts of consolidation: some positive, some neutral or ambiguous, and some negative. Stakeholders perceived consolidation's positive impacts on long-term viability of health care facilities and their ability to adopt new care models, enhanced competition in health insurance, creation of foundations, and pioneering medical research and innovation. Stakeholders also believed that consolidation changed geographic access to care, physician referral behaviors, how educated patients were about their health care, the health care advertising environment, and economies of surrounding neighborhoods. Interviewees noted that consolidation raised questions about what the responsibilities of non-profit organizations are to their communities. However, stakeholders also reported their perceptions of negative outcomes, including ways in which consolidation had potentially reduced patient access to care, accountability and transparency, systems' willingness to collaborate, and physician autonomy. As trends toward consolidation are not slowing, there will be many opportunities to experiment with policy levers to mitigate its potentially negative consequences.

Access, Quality, And Financial Performance Of Rural Hospitals Following Health System Affiliation.

More than 100 rural hospitals have closed since 2010. Some rural hospitals have affiliated with health systems to improve their financial performance and potentially avoid closure, but the effects of affiliation on rural hospitals and their patients are unclear. To examine the relationship between affiliation and performance, we compared rural hospitals that affiliated with a health system in the period 2008-17 and a propensity score-weighted set of nonaffiliating rural hospitals on twelve measures of structure, utilization, financial performance, and quality. Following health system affiliation, rural hospitals experienced a significant reduction in on-site diagnostic imaging technologies, the availability of obstetric and primary care services, and outpatient nonemergency visits, as well as a significant increase in operating margins (by 1.6-3.6 percentage points from a baseline of -1.6 percent). Changes in patient experience scores, readmissions, and emergency department visits were similar for affiliating and nonaffiliating hospitals. While joining health systems may improve rural hospitals' financial performance, affiliation may reduce access to services for patients in rural areas.

Spread tools: a systematic review of components, uptake, and effectiveness of quality improvement toolkits.

BACKGROUND: The objective was to conduct a systematic review of toolkit evaluations intended to spread interventions to improve healthcare quality. We aimed to determine the components, uptake, and effectiveness of publicly available toolkits. METHODS: We searched PubMed, CINAHL, and the Web of Science from 2005 to May 2018 for evaluations of publicly available toolkits, used a forward search of known toolkits, screened references, and contacted topic experts. Two independent reviewers screened publications for inclusion. One reviewer abstracted data and appraised the studies, checked by a second reviewer; reviewers resolved disagreements through discussion. Findings, summarized in comprehensive evidence tables and narrative synthesis addressed the uptake and utility, procedural and organizational outcomes, provider outcomes, and patient outcomes. RESULTS: In total, 77 studies evaluating 72 toolkits met inclusion criteria. Toolkits addressed a variety of quality improvement approaches and focused on clinical topics such as weight management, fall prevention, vaccination, hospital-acquired infections, pain management, and patient safety. Most toolkits included introductory and implementation material (e.g., research summaries) and healthcare provider tools (e.g., care plans), and two-thirds included material for patients (e.g., information leaflets). Pre-post studies were most common (55%); 10% were single hospital evaluations and the number of participating staff ranged from 17 to 704. Uptake data were limited and toolkit uptake was highly variable. Studies generally indicated high satisfaction with toolkits, but the perceived usefulness of individual tools varied. Across studies, 57% reported on adherence to clinical procedures and toolkit effects were positive. Provider data were reported in 40% of studies but were primarily self-reported changes. Only 29% reported patient data and, overall, results from robust study designs are missing from the evidence base. CONCLUSIONS: The review documents publicly available toolkits and their components. Available uptake data are limited but indicate variability. High satisfaction with toolkits can be achieved but the usefulness of individual tools may vary. The existing evidence base on the effectiveness of toolkits remains limited. While emerging evidence indicates positive effects on clinical processes, more research on toolkit value and what affects it is needed, including linking toolkits to objective provider behavior measures and patient outcomes. TRIAL REGISTRATION: PROSPERO registration number: PROSPERO 2014: CRD42014013930 .

Medical Practice Consolidation and Physician Shared Patient Network Size, Strength, and Stability.

BACKGROUND: Properties of social networks and shared patient networks of physicians are associated with important outcomes, including costs, quality, information exchange, and organizational effectiveness. OBJECTIVES: To determine whether practice consolidation affects size, strength, and stability of US practice-based physician shared patient networks. RESEARCH DESIGN: We used a dynamic difference-in-differences (event study) design to determine how 2 types of vertical consolidation (hospital and health system practice acquisition) and 2 types of horizontal consolidation (medical group membership and practice-practice mergers) affect individual shared patient network characteristics, controlling for physician fixed effects and geographic market (metropolitan statistical area). SUBJECTS: Practice-based US physicians whose practices consolidated 2009-2014 are identified via health system, hospital, and medical group affiliation information and appearance/disappearance of listed practice affiliations in the SK&A Physician Database. MEASURES: Outcomes measured were network size (number of individual physicians with whom a physician shares patients within 30 d), strength (average number of shared patients within those relationships), and stability (percent of shared patient relationships that persist in the current and prior year), all generated from Medicare Shared Patient Patterns (30-d) data. RESULTS: Shared patient network stability increases significantly after acquisition of practices by horizontal practice-practice mergers [ßt=1=0.041 (P<0.001), ßt=2=0.047 (P<0.001), ßt=3=0.041 (P<0.001), ßt=4=0.031 (P<0.05), where t is the number of years after the consolidation event]. These effects were robust to sensitivity analyses. Shared patient network size and strength are not observably associated with practice consolidation events. CONCLUSIONS: Practice consolidation can increase the stability of physician networks, which may have positive implications for organizational effectiveness.

What kills us and what moves us: A comparative discourse analysis of heart disease and breast cancer.

INTRODUCTION: Heart disease kills nearly 300,000 US women annually, while approximately 40,000 US women die of breast cancer. Breast cancer online patient communities are well known for their high engagement and emotional support. This exploratory study compared social media discourse on breast cancer with discourse related to heart disease. METHODS: Computer-assisted text analysis of two corpora composed of Twitter posts using #BreastCancer and #HeartDisease hashtags from December 2013 to December 2014. Lexical analysis (word and hashtag level) used AntConc software and lexicogrammatical analysis (style and stance) was conducted with DocuScope. RESULTS: The #BreastCancer corpus consisted of 592,046 posts, 57% of which were not original to the user (retweets). #HeartDisease had 269,769 posts (13% retweets). Social media discourse about #BreastCancer and #HeartDisease drew attention to women, new developments, appeals for help and disease risks. The #BreastCancer corpus incorporates gendered language and associations with art and activism, while posts about #HeartDisease were discussed scientifically in concert with other diseases. The #BreastCancer corpus uniquely included community-specific initialism hashtags. Stance analysis of the #BreastCancer corpus revealed more socially oriented posts, marked by language of constructive reasoning, inclusive language and abstract thought, while #HeartDisease corpus posts were more scholarly, used contingent and oppositional reasoning, language from institutional and academic registers, citations and meta-discourse. CONCLUSION: The #HeartDisease social media community is less engaged, and content is less specific to both the disease and individual experience than #BreastCancer. Cultivating a women-focused heart disease online community might replicate some of the #BreastCancer community's successes.