Cost-Effectiveness of a Homeless Care Transition Program: Durham Homeless Care Transitions.

BACKGROUND Transitional care and medical respite programs provide assistance to people experiencing homelessness as they move from acute care into community settings. These programs can address issues that may fall outside the reach of traditional medical care yet have a profound impact on the health of vulnerable populations. This article focuses on the cost-effectiveness of the Durham Homeless Care Transitions (DHCT) program.METHOD This intervention study of the DHCT program uses a comparison group of people experiencing homelessness who were referred but did not participate. Encounter-level data, aggregated by quarterly segments of charges and reimbursements, were abstracted for all persons referred. Descriptive statistics were computed and models of charges and reimbursements were created using ordinary least squares (OLS) regression to compare utilization for 12 months pre- and post-referral.RESULTS Patients referred to the DHCT program (N = 485) were primarily non-Hispanic Black (62.5%), male (68.4%), uninsured (35.5%), and had an average of 5.3 chronic conditions and an average age of 50.0 years (SD = 11.3). There was variability among charges and reimbursement based on health care visit type but a negative association between treatment and charges, indicating that being part of the DHCT program led to lower charges post-referral.LIMITATIONS The study is limited by lack of access to line-item details of charges, reimbursement, and payer mix.CONCLUSION There is evidence of benefit to patients from transitional care and medical respite programs that does not substantially increase the overall societal cost of care; however, health systems commonly require evidence of cost savings and benefit as a return on investment.

Selection Bias in Observational Studies of Palliative Care: Lessons Learned.

CONTEXT: Palliative care (PC) programs are typically evaluated using observational data, raising concerns about selection bias. OBJECTIVES: To quantify selection bias because of observed and unobserved characteristics in a PC demonstration program. METHODS: Program administrative data and 100% Medicare claims data in two states and a 20% sample in eight states (2013-2017). The sample included 2983 Medicare fee-for-service beneficiaries aged 65+ participating in the PC program and three matched cohorts: regional; two states; and eight states. Confounding because of observed factors was measured by comparing patient baseline characteristics. Confounding because of unobserved factors was measured by comparing days of follow-up and six-month and one-year mortality rates. RESULTS: After matching, evidence for observed confounding included differences in observable baseline characteristics, including race, morbidity, and utilization. Evidence for unobserved confounding included significantly longer mean follow-up in the regional, two-state, and eight-state comparison cohorts, with 207 (P < 0.001), 192 (P < 0.001), and 187 (P < 0.001) days, respectively, compared with the 162 days for the PC cohort. The PC cohort had higher six-month and one-year mortality rates of 53.5% and 64.5% compared with 43.5% and 48.0% in the regional comparison, 53.4% and 57.4% in the two-state comparison, and 55.0% and 59.0% in the eight-state comparison. CONCLUSION: This case study demonstrates that selection of comparison groups impacts the magnitude of measured and unmeasured confounding, which may change effect estimates. The substantial impact of confounding on effect estimates in this study raises concerns about the evaluation of novel serious illness care models in the absence of randomization. We present key lessons learned for improving future evaluations of PC using observational study designs.

Associations of Patient Characteristics and Care Setting with Complexity of Specialty Palliative Care Visits.

Background: Information routinely collected during a palliative care consultation request may help predict the level of complexity of that patient encounter. Objectives: We examined whether patient and consultation characteristics, as captured in consultation requests, are associated with the number of unmet palliative care needs that emerge during consultation, as an indicator of complexity. Design: We performed a retrospective cohort analysis of palliative care consultations. Setting: We analyzed quality-of-care data from specialty palliative care consultations contained in the Quality Data Collection Tool of the Global Palliative Care Quality Alliance from 2012 to 2017. Measurements: Using 13 point-of-care assessments of quality of life, symptoms, advance care planning, and prognosis, we created a complexity score ranging from 0 (not complex) to 13 (highest complexity). Using multivariable linear regression, we examined the relationships of consultation setting and patient characteristics with complexity score. Results: Patients in our cohort (N = 3121) had an average complexity score of 6.7 (standard deviation = 3.7). Female gender, nonwhite race, and neurological (e.g., dementia) and noncancer primary diagnosis were associated with increased complexity score. The hospital intensive care unit, compared with the general floor, was associated with higher complexity scores. In contrast, outpatient and residence, compared with the general floor, were associated with lower complexity scores. Conclusion: Patient, disease, and care setting factors known at the time of specialty palliative care consultation request are associated with level of complexity, and they may inform teams about the right service provisions, including time and expertise, required to meet patient needs.

Provision and Utilization of Team- and Community-Based Operative Care for Patients With Cleft Lip/Palate in North Carolina.

OBJECTIVE: To characterize operative care for cleft lip and/or palate (CL/P) based on location (ie, from American Cleft Palate Craniofacial Association [ACPA]-approved multidisciplinary teams or from community providers). DESIGN: Cross-sectional analysis of Healthcare Cost and Utilization Project State Inpatient Database and State Ambulatory Surgery & Services Database databases for North Carolina from 2012 to 2015. SETTING/PATIENTS AND MAIN OUTCOME MEASURES: Clinical encounters for children with CL/P undergoing operative procedures were identified, classified by location as "Team" versus "Community," and characterized by demographic, geographic, clinical, and procedural factors. A secondary evaluation reviewed concordance of team and community practices with an ACPA guideline related to coordination of care. RESULTS: Three teams and 39 community providers performed a total of 3010 cleft-related procedures across 2070 encounters. Teams performed 69.7% of total volume and performed the majority of cleft procedures, including cleft lip repair, palate repair, alveolar bone grafting, and correction of velopharyngeal insufficiency. Community locations principally offered myringotomy and rhinoplasty. Team care was associated with higher guideline concordance. CONCLUSIONS: American Cleft Palate Craniofacial Association -approved team-based care accounts for the majority of cleft-related care in North Carolina; however, a substantial volume of cleft-related procedures was provided by community providers, with 3 providers accounting for the vast majority of community cases.

Feasibility of Cancer Clinical Trial Enrollment Goals Based on Cancer Incidence.

PURPOSE: More than 20% of US clinical trials fail to accrue sufficiently. Our purpose was to provide a benchmark for better understanding clinical trial enrollment feasibility and to assess relative levels of competition for patients by cancer diagnosis. METHODS: The Database for Aggregate Analysis of ClinicalTrials.gov, up to date as of September 3, 2017, was used to identify actively recruiting, interventional oncology trials with US sites. Observational studies were excluded because not all are registered. Trials were categorized through Medical Subject Headings or free-text condition terms and sorted by cancer diagnosis. Trials that included more than one cancer diagnosis were included in the overall cohort but excluded when evaluating enrollment by cancer type. Trial enrollment slot availability was estimated between September 1, 2017, and August 31, 2018. Availability was estimated from total anticipated enrollment and duration, assuming a constant recruitment rate. Estimates for studies with both foreign and domestic sites were then prorated to calculate available enrollment in the United States alone. Ratios of the number of newly diagnosed patients in the United States available per trial slot were estimated using the American Cancer Society cancer incidence estimates for 2017. RESULTS: A total of 4,598 interventional oncology trials were identified. Overall, the estimated ratio of newly diagnosed patients available per trial slot was 12.6. Estimated ratios of patients per trial slot for six cancer diagnoses with the highest potential of 12-month US enrollment were as follows: colorectal, 24.7; lung and bronchus, 20.1; prostate, 17.6; breast (female), 13.8; leukemia, 11.6; and brain and other nervous system, 6.0. CONCLUSION: For all cancers, successfully accruing trials currently open would require that more than one in every 13 recently diagnosed patients (7.9%) enroll. This ratio and relative difficulty of accrual varies among cancers examined.

Use of Hospital Referral Regions in Evaluating End-of-Life Care.

Background: Hospital referral regions (HRRs) are often used to characterize inpatient referral patterns, but it is unknown how well these geographic regions are aligned with variation in Medicare-financed hospice care, which is largely provided at home. Objective: Our objective was to characterize the variability in hospice use rates among elderly Medicare decedents by HRR and county. Methods: Using 2014 Master Beneficiary File for decedents 65 and older from North and South Carolina, we applied Bayesian mixed models to quantify variation in hospice use rates explained by HRR fixed effects, county random effects, and residual error among Medicare decedents. Results: We found HRRs and county indicators are significant predictors of hospice use in NC and SC; however, the relative variation within HRRs and associated residual variation is substantial. On average, HRR fixed effects explained more variation in hospice use rates than county indicators with a standard deviation (SD) of 10.0 versus 5.1 percentage points. The SD of the residual error is 5.7 percentage points. On average, variation within HRRs is about half the variation between regions (52%). Conclusions: The magnitude of unexplained residual variation in hospice use for NC and SC suggests that novel, end-of-life-specific service areas should be developed and tested to better capture geographic differences and inform research, health systems, and policy.

Paying for Palliative Care in Medicare: Evidence From the Four Seasons/Duke CMMI Demonstration.

CONTEXT: Palliative care improves patient and family outcomes and may reduce the cost of care, but this service is underutilized among Medicare beneficiaries. OBJECTIVES: To describe enrollment patterns and outcomes associated with the Center for Medicare and Medicaid Innovation expansion of a multisetting community palliative care program in North and South Carolina. METHODS: This observational study characterizes the Center for Medicare and Medicaid Innovation cohort's care and cost trajectories after enrollment. Program participants were age-eligible Medicare fee-for-service beneficiaries living in Western North Carolina and South Carolina who enrolled in a palliative care program from September 1, 2014, to August 31, 2017. End-of-life costs were compared between enrolled and nonenrolled decedents. Program administrative data and 100% Medicare claims data were used. RESULTS: A total of 5243 Medicare beneficiaries enrolled in the program from community (19%), facility (21%), small hospital (27%), or large hospital (33%) settings. Changes in Medicare expenditures in the 30 days after enrollment varied by setting. Adjusted odds of hospice use were 60% higher (OR = 1.60; CI = 1.47, 1.75) for enrolled decedents relative to nonenrolled decedents. Participants discharged to hospice vs. participants not had 17% (OR = 0.83 CI = 0.72, 0.94) lower costs. Among enrolled decedents those enrolled for at least 30 days vs. <30 days had 42% (OR = 0.58, CI = 0.49, 0.69) lower costs in the last 30 days of life. CONCLUSIONS: Expansion of community palliative care programs into multiple enrollment settings is feasible. It may improve hospice utilization among enrollees. Heterogeneous program participation by program setting pose challenges to a standardizing reimbursement policy.

Death of outrage over talking about dying.

OBJECTIVES: We examined public reaction to the proposed Center for Medicare and Medicaid Services rule reimbursing physicians for advanced care planning (ACP) discussions with patients. METHODS: Public comments made on regulations.gov were reviewed for relevance to ACP policy and their perceived position on ACP (ie, positive, negative and neutral). Descriptive statistics were used to quantify the results. RESULTS: A total of 2225 comments were submitted to regulations.gov. On review, 69.0% were categorised as irrelevant; among relevant comments (n=689), 81.1% were positive, 18.6% were negative and 0.002% were neutral. Individuals submitted a greater percentage of the total comments as compared to organisations (63.5% and 36.5%, respectively). CONCLUSIONS: The US Medicare programme is a tax financed social insurance programme that covers all patients 65 years of age and older, including 8 in 10 decedents annually, and it is the part of the US healthcare system most similar to the rest of world. There has been a trend globally towards recognising the importance of aligning patient preferences with care options, including palliative care to deal with advanced life limiting illness. However, ACP is not widely used in the USA, potentially reducing the use of palliative care. Reimbursing ACP discussions between physicians, patients and their family has the potential to have a large impact on the quality of life of persons near death, which can greatly impact public health and the comfort in dealing with our ultimate demise.

Predicting Length of Hospice Stay: An Application of Quantile Regression.

BACKGROUND: Use of the Medicare hospice benefit has been associated with high-quality care at the end of life, and hospice length of use in particular has been used as a proxy for appropriate timing of hospice enrollment. Quantile regression has been underutilized as an alternative tool to model distributional changes in hospice length of use and hospice payments outside of the mean. OBJECTIVE: To test for heterogeneity in the relationship between patient characteristics and hospice outcomes across the distribution of hospice days. SETTING: Medicare Beneficiary Summary File and survey data (2014) for hospice beneficiaries in North and South Carolina with common terminal diagnoses. MEASUREMENTS: Distributional shifts associated with patient characteristics were evaluated at the 25th and 75th percentiles of hospice days and hospice payments using quantile regressions and compared to the mean shift estimated by ordinary least squares (OLS) regression. PRINCIPAL FINDINGS: Significant (p < 0.001) heterogeneity in the marginal effects on hospice days and costs was observed, with patient characteristics associated with generally larger shifts in the 75th percentile than the 25th percentile. Mean effects estimated by OLS regression overestimate the magnitude of the median marginal effects for all patient characteristics except for race. Results for hospice payments in 2014 were similar. CONCLUSIONS: Methodological decisions can have a meaningful impact in the evaluation of factors influencing hospice length of use or cost.

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

OBJECTIVE: To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. METHODS: In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. RESULTS: Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that "wishful thinking" may cloud their recommendations. CONCLUSIONS: Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project.

BACKGROUND: While patient groups, regulators, and sponsors are increasingly considering engaging with patients in the design and conduct of clinical development programs, sponsors are often reluctant to go beyond pilot programs because of uncertainty in the return on investment. We developed an approach to estimate the financial value of patient engagement. METHODS: Expected net present value (ENPV) is a common technique that integrates the key business drivers of cost, time, revenue, and risk into a summary metric for project strategy and portfolio decisions. We assessed the impact of patient engagement on ENPV for a typical oncology development program entering phase 2 or phase 3. RESULTS: For a pre-phase 2 project, the cumulative impact of a patient engagement activity that avoids one protocol amendment and improves enrollment, adherence, and retention is an increase in net present value (NPV) of $62MM ($65MM for pre-phase 3) and an increase in ENPV of $35MM ($75MM for pre-phase 3). Compared with an investment of $100,000 in patient engagement, the NPV and ENPV increases can exceed 500-fold the investment. This ENPV increase is the equivalent of accelerating a pre-phase 2 product launch by 2½ years (1½ years for pre-phase 3). CONCLUSIONS: Risk-adjusted financial models can assess the impact of patient engagement. A combination of empirical data and subjective parameter estimates shows that engagement activities with the potential to avoid protocol amendments and/or improve enrollment, adherence, and retention may add considerable financial value. This approach can help sponsors assess patient engagement investment decisions.

Hospital-Based Palliative Care with Medicare Claims: Evidence From Colorado.

BACKGROUND: The prevalence of hospital-based palliative care has been largely anecdotal as an increasing service being provided and there is a need to understand what trends can be analyzed with Medicare data. OBJECTIVE: To compare 2 methods of identifying hospital-based palliative care in the Medicare population in Colorado. STUDY DESIGN: Through Medicare claims data and phone surveys, we ascertained the presence of hospital-based palliative care services, number of patients receiving palliative care, and number of care visits provided during the previous year. DATA SOURCES/STUDY SETTING: Data were collected from every Medicare-certified hospital in Colorado during 2008 and 2013. MEASUREMENTS: We measured the presence of hospital-based palliative care teams and their average number of consultations through a phone survey and cross-referenced using a v-code modifier of Medicare claims indicating a palliative care consult visit. RESULTS: The number of hospital-based palliative care consultations increased five-fold from 2008-2013, and Medicare claims under-counted the number of these consultations compared to phone surveys. CONCLUSION: The systematic measurement of palliative care nationally is a key priority. More evidence is needed from other states to better understand the usefulness of Medicare claims in this effort.

Standardization and Scaling of a Community-Based Palliative Care Model.

BACKGROUND: Although limited, the descriptions of Community-Based Palliative Care (CBPC) demonstrates variability in team structures, eligibility, and standardization across care settings. OBJECTIVE: In 2014, Four Seasons Compassion for Life, a nonprofit hospice and palliative care (PC) organization in Western North Carolina (WNC), was awarded a Centers for Medicare and Medicaid Services Health Care Innovation (CMMI) Award to expand upon their existing innovative model to implement, evaluate, and demonstrate CBPC in the United States. The objective of this article is to describe the processes and challenges of scaling and standardizing the CBPC model. DESIGN: Four Season's CBPC model serves patients in both inpatient and outpatient settings using an interdisciplinary team to address symptom management, psychosocial/spiritual care, advance care planning, and patient/family education. Medicare beneficiaries who are ≥65 years of age with a life-limiting illness were eligible for the CMMI project. RESULTS: The CBPC model was scaled across numerous counties in WNC and Upstate South Carolina. Over the first two years of the project, scaling occurred into 21 counties with the addition of 2 large hospitals, 52 nursing facilities, and 2 new clinics. To improve efficiency and effectiveness, a PC screening referral guide and a risk stratification approach were developed and implemented. Care processes, including patient referral and initial visit, were mapped. CONCLUSION: This article describes an interdisciplinary CBPC model in all care settings to individuals with life-limiting illness and offers guidance for risk stratification assessments and mapping care processes that may help PC programs as they develop and work to improve efficiencies.

One Size Does Not Fit All: Disease Profiles of Serious Illness Patients Receiving Specialty Palliative Care.

INTRODUCTION: Understanding the symptom profiles of seriously ill patients who receive palliative care, especially noncancer diagnoses where the data are sparse and are critical to better targeting our resources to the needs of patients. METHODS: We performed a retrospective, multicohort study of patients evaluated during their first consultative palliative care visit in a community-based palliative care registry. We placed into one of seven major disease categories based on clinician-reported primary diagnosis for consultation. Our primary aim of this analysis was to determine the univariate association between several patient-specific characteristics (e.g., demographics, care of setting, initial screening score) and the primary diagnosis. RESULTS: We evaluated the first visit consultation records of 1615 patients. Most prevalent diagnosis was Neurologic (564; 35%), followed by Cardiovascular (266; 16%), Pulmonary (229; 14%), and Cancer (208; 13%). Patients in the study with the highest symptom burden were those diagnosed with cancer or pulmonary disease, with 45% and 37% of cancer and pulmonary patients, respectively, having two or more moderate-to-severe symptoms; 26% of cardiovascular disease patients reported two or more moderate-to-severe symptoms, whereas 11% reported three or more. Patients with a neurologic or infectious diagnosis had less symptom burden, but a large percentage of neurologic patients were unable to respond. DISCUSSION: This study is one of the first to describe symptom burden and functional scores by diagnostic categories and care settings across a community-based interdisciplinary specialty palliative care program. Results demonstrated statistically significant and clinically relevant differences among settings of care, functional status, and symptom profiles between patients with various serious illnesses.

Tracking Patients in Community-Based Palliative Care through the Centers for Medicare & Medicaid Services Healthcare Innovation Project.

BACKGROUND: Although limited, the evidence base for Community-Based Palliative Care (CBPC) has shown that it improves patient health outcomes, increases satisfaction, and decreases cost. Minimal data exist comparing points of entry into palliative care and patient transition outcomes. OBJECTIVES: In 2014, Four Seasons Compassion for Life was awarded a Centers for Medicare & Medicaid Services Healthcare Innovation Award to expand an existing CBPC model into additional counties and to propose a new payment approach. The goal of this article is to evaluate the tracking of point of entry into palliative care and patient transition outcomes in the model. DESIGN: All participant transition outcomes are tracked from point of entry, including large and small hospitals, nursing facilities, and home/clinic. Evaluation of tracking data was conducted over the first two years of the project (September 1, 2014-September 1, 2016). RESULTS: A total of 2482 patients entered the project, 905 through smaller hospitals (<300 beds, 32%), 474 through larger hospital systems (>500 beds, 17%), 823 from nursing facilities (29%), and 640 in the home/clinic (22%). Hospice transition was highest with home/clinic referrals, followed by nursing facilities, smaller hospitals, and larger hospitals. Palliative care deaths and discharges are higher in larger hospitals. Re-enrollment back into palliative care after previous discharge occurred in 177 (17.8%) of discharged patients. CONCLUSION: CBPC leads to the highest percentage of hospice transitions coming from the home/clinic setting. Differences between small and large hospitals demonstrate a different patient population with higher transitions to hospice and lower palliative care deaths in smaller hospitals.

Delivery of Community-Based Palliative Care: Findings from a Time and Motion Study.

BACKGROUND: Use of palliative care has increased substantially as the population ages and as evidence for its benefits grows. However, there is limited information regarding which care activities are necessary for delivering high-quality, interdisciplinary, community-based palliative care. OBJECTIVES: This study aims to identify and measure the discrete clinical and administrative activities completed by a multidisciplinary team in a hospice provider-led model for providing community-based palliative care. STUDY DESIGN: A time and motion study was conducted at three care settings within a large hospice and palliative care network and a process map was drawn to describe the personnel and activities recorded. METHODS: Researchers recorded activities performed by clinical and administrative staff. Activities were categorized into those related to patient care, administrative duties, care coordination, and other. A process map of palliative care delivery was created and descriptive statistics were used to calculate the proportion of time spent on discrete activities and within each activity category. RESULTS: Over 50 hours of activities were recorded during which the clinicians interacted with 25 patients and engaged in 20 distinct tasks. Physicians spent 94% of their time on tasks related to patient care and 1% on administrative tasks. Nurse practitioners and registered nurses spent 82% and 53% of their time on patient-related tasks and 2% and 37% on administrative tasks, respectively. CONCLUSION: The delivery of palliative care is interdisciplinary and involves numerous discrete tasks and activities. Understanding the components of a community-based palliative care model is the first step to designing incentives to encourage its spread.

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey.

OBJECTIVE: Patient-centered clinical trial design and execution is becoming increasingly important. No best practice guidelines exist despite a key stakeholder declaration to create more effective engagement models. This study aims to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed. METHODS: Individuals from industry, academic institutions, and patient groups were identified through Clinical Trials Transformation Initiative and Drug Information Association rosters and mailing lists. Objectives, practices, and perceived barriers related to engaging patient groups in the planning, conduct, and interpretation of clinical trials were reported in an online survey. Descriptive and inferential statistical analysis of survey data followed a literature review to inform survey questions. RESULTS: Survey respondents (n = 179) valued the importance of involving patient groups in research; however, patient group respondents valued their contributions to research protocol development, funding acquisition, and interpretation of study results more highly than those contributions were valued by industry and academic respondents (all p < .001). Patient group respondents placed higher value in open communications, clear expectations, and detailed contract execution than did non-patient group respondents (all p < .05). Industry and academic respondents more often cited internal bureaucratic processes and reluctance to share information as engagement barriers than did patient group respondents (all p < .01). Patient groups reported that a lack of transparency and understanding of the benefits of collaboration on the part of industry and academia were greater barriers than did non-patient group respondents (all p< .01). CONCLUSIONS: Despite reported similarities among approaches to engagement by the three stakeholder groups, key differences exist in perceived barriers and benefits to partnering with patient groups among the sectors studied. This recognition could inform the development of best practices for patient-centered clinical trial design and execution. Additional research is needed to define and optimize key success factors.

A prescription for clinical immunology: the pills are available and ready for testing. A review.

OBJECTIVE: Modern immunology has been extremely successful in elucidating many features of the immune system, but not in stemming pandemics of non-infectious, immune-related disease associated with industrialized populations. These pandemics involve a broad range of allergic, autoimmune, and inflammatory diseases, potentially including neuroinflammatory-associated disorders. It is the purpose of this review to outline the literature pointing toward the causes and potential treatments of these problems. CONCLUSIONS: A wide range of evidence from the fields of clinical medicine, biomedical research, evolutionary biology, anthropology, epidemiology, immunology, and ecology point to the conclusion that pandemics of non-infectious, immune-related conditions arise from consequences of industrialization. Primary among these consequences is the loss of helminths from the ecosystem of the human body, the 'human biome'. In this view, helminths comprise a 'keystone species' of the human biome, and their loss is profoundly felt as pandemics of non-infectious, immune-related disease. Fortunately, evidence indicates that the consequences of industrialization that cause immune disease, such as helminth depletion, can be effectively avoided. Using this approach, it is expected that further pandemics of immune disease may be prevented, although it remains to be established whether prophylaxis rather than treatment of disease is required for some disorders. Thus, it is predicted that those who will succeed in curing and preventing immune-related disease will focus on addressing 'evolutionary mismatches' rather than simply on the molecular and genetic underpinnings of immunological disorders.

Establishing a regional, multisite database for quality improvement and service planning in community-based palliative care and hospice.

BACKGROUND: Outpatient palliative care, an evolving delivery model, seeks to improve continuity of care across settings and to increase access to services in hospice and palliative medicine (HPM). It can provide a critical bridge between inpatient palliative care and hospice, filling the gap in community-based supportive care for patients with advanced life-limiting illness. Low capacities for data collection and quantitative research in HPM have impeded assessment of the impact of outpatient palliative care. APPROACH: In North Carolina, a regional database for community-based palliative care has been created through a unique partnership between a HPM organization and academic medical center. This database flexibly uses information technology to collect patient data, entered at the point of care (e.g., home, inpatient hospice, assisted living facility, nursing home). HPM physicians and nurse practitioners collect data; data are transferred to an academic site that assists with analyses and data management. Reports to community-based sites, based on data they provide, create a better understanding of local care quality. CURRENT STATUS: The data system was developed and implemented over a 2-year period, starting with one community-based HPM site and expanding to four. Data collection methods were collaboratively created and refined. The database continues to grow. Analyses presented herein examine data from one site and encompass 2572 visits from 970 new patients, characterizing the population, symptom profiles, and change in symptoms after intervention. CONCLUSION: A collaborative regional approach to HPM data can support evaluation and improvement of palliative care quality at the local, aggregated, and statewide levels.