The effect of immigration status on racial differences in health insurance coverage, access to care, and utilization in the United States

Background. Lack of coverage, lack of access, and failure to utilize health care services have all been linked to dismal health outcomes in the US. Such consequences have been a longstanding challenge that US minorities are faced with, in the context of a health care system believed to be lacking efficiency and equity. National population surveys in the US suggest that the number of uninsured approaches 50 millions, while some concerns and suspicions are raised by opponents to the growing number of foreign born US residents, many of whom are Hispanic. Research shows that race is a significant predictor of lack of coverage, access, and utilization, while age, gender, education, and income are also linked to these outcomes. We investigated the potential effect of immigration status or duration in the US on the association between coverage, access, use, and race. Methods. Using National Health Interview Survey (NHIS) data of 2006, we selected 22, 667 individuals of Non-Hispanic Black, Hispanic, and Non-Hispanic White descent, at least 18 years of age, US-born and foreign-born who reported their duration of residence in the US. Through complex sample survey logistic regression analysis, we computed odds ratios, beta coefficients, and 95% confidence intervals using models which excluded then included immigration status. Results. Although a significant predictor of the outcomes, immigration status did not change the relationship between each of the dependent variables (coverage, access, utilization), and the factor race, while adjusting for age, gender, education, and income. Our results show that Hispanics were least likely to have coverage (OR=.58; 95% CI[.49, .68]), access (OR=.62; 95% CI[.50, .76]), and to utilize services (OR=.60; 95% CI[.46, .79]) followed by Non-Hispanic Blacks, and Non-Hispanic Whites. These results were not changed by stratification, or the inclusion of interaction terms to eliminate the potential effect of relationships between independent variables. Recent immigrants (<5 years in US) were 0.12 times less likely to be insured, but also 0.26 times less likely to utilize services (p<0.001), and in addition they represented only 7.3% of the uninsured and 1.9% of the US population in 2006. Furthermore, 12% of the Non-Hispanic White population in the US was not covered, and 65% of the uninsured individuals were US-Born Citizens. Other predictors of lack of coverage, access and use were age below 45, male gender, education at high school or below, and income of less than $20,000. Conclusion. This investigation shows that the high percentage of uninsured was not directly caused by Hispanics, and immigration status alone could not explain racial differences in coverage, access, and utilization. An immigration reform may not be the solution to the healthcare crisis, and more specifically, will not stop the increase in the number of uninsured in the US, nor reduce the cost of health care. As a better alternative, universal health insu rance coverage should be considered, when aiming to eliminate racial disparities, and to solve the health care crisis. ^ Keywords. health insurance, coverage, access, utilization, race, immigration, disparities.^

An analysis of the effects of a peer mentor program and other factors on HIV patients' retention in care and clinical outcomes at Thomas Street Health Clinic, Houston Texas

Research examining programs designed to retain patients in health care focus on repeated interactions between outreach workers and patients (Bradford et al. 2007; Cheever 2007). The purpose of this study was to determine if patients who are peer-mentored at their intake exam remain in care longer and attend more physicians' visits than those who were not mentored. Using patients' medical records and a previously created mentor database, the study determined how many patients attended their intake visit but subsequently failed to establish regular care. The cohort study examined risk factors for establishing care, determined if patients lacking a peer mentor failed to establish care more than peer mentor assisted patients, and subsequently if peer mentored patients had better health outcomes. The sample consists of 1639 patients who were entered into the Thomas Street Patient Mentor Database between May 2005 and June 2007. The assignment to the mentored group was haphazardly conducted based on mentor availability. The data from the Mentor Database was then analyzed using descriptive statistical software (SPSS version 15; SPSS Inc., Chicago, Illinois, USA). Results indicated that patients who had a mentor at intake were more likely to return for primary care HIV visits at 90 and 180 days. Mentored patients also were more likely to be prescribed ART within 180 days from intake. Other risk factors that impacted remaining in care included gender, previous care status, time from diagnosis to intake visit, and intravenous drug use. Clinical health outcomes did not differ significantly between groups. This supports that mentoring did improve outcomes. Continuing to use peer-mentoring programs for HIV care may help in increasing retention of patients in care and improving patients' health in a cost effective manner. Future research on the effects of peer mentoring on mentors, and effects of concordance of mentor and patient demographics may help to further improve peer-mentoring programs. ^

The impact of Medicare, Medicaid and Schip Extension Act of 2007 (MMSEA) on the long term acute care hospitals

The Long Term Acute Care Hospitals (LTACH), which serve medically complex patients, have grown tremendously in recent years, by expanding the number of Medicare patient admissions and thus increasing Medicare expenditures (Stark 2004). In an attempt to mitigate the rapid growth of the LTACHs and reduce related Medicare expenditures, Congress enacted Section 114 of P.L. 110-173 (§114) of the Medicare, Medicaid and SCHIP Extension Act (MMSEA) in December 29, 2007 to regulate the LTCAHs industry. MMSEA increased the medical necessity reviews for Medicare admissions, imposed a moratorium on new LTCAHs, and allowed the Centers for Medicare and Medicaid Services (CMS) to recoup Medicare overpayments for unnecessary admissions. ^ This study examines whether MMSEA impacted LTACH admissions, operating margins and efficiency. These objectives were analyzed by comparing LTACH data for 2008 (post MMSEA) and data for 2006-2007 (pre-MMSEA). Secondary data were utilized from the American Hospital Association (AHA) database and the American Hospital Directory (AHD).^ This is a longitudinal retrospective study with a total sample of 55 LTACHs, selected from 396 LTACHs facilities that were fully operational during the study period of 2006-2008. The results of the research found no statistically significant change in total Medicare admissions; instead there was a small but not statistically significant reduction of 5% in Medicare admissions for 2008 in comparison to those for 2006. A statistically significant decrease in mean operating margins was confirmed between the years 2006 and 2008. The LTACHs' Technical Efficiency (TE), as computed by Data Envelopment Analysis (DEA), showed significant decrease in efficiency over the same period. Thirteen of the 55 LTACHs in the sample (24%) in 2006 were calculated as “efficient” utilizing the DEA analysis. This dropped to 13% (7/55) in 2008. Longitudinally, the decrease in efficiency using the DEA extension technique (Malmquist Index or MI) indicated a deterioration of 10% in efficiency over the same period. Interestingly, however, when the sample was stratified into high efficient versus low efficient subgroups (approximately 25% in each group), a comparison of the MIs suggested a significant improvement in Efficiency Change (EC) for the least efficient (MI 0.92022) and reduction in efficiency for the most efficient LTACHs (MI = 1.38761) over same period. While a reduction in efficiency for the most efficient is unexpected, it is not particularly surprising, since efficiency measure can vary over time. An improvement in efficiency, however, for the least efficient should be expected as those LTACHs begin to manage expenses (and controllable resources) more carefully to offset the payment/reimbursement pressures on their margins from MMSEA.^

Charity care and community benefits by hospital type in Texas

Hospital care is the largest component of the health care sector. This industry is made up of for profit hospital (FPH) organizations, not for profit (NFP) hospitals, and government (GOV) run hospital facilities. Objectives of this analysis were: (a) to conduct a literature review on NFP hospital legislation at the state level in Texas and at the federal level in the broader U.S.; and (b) to describe the types of charity care and community benefits currently being provided: by NFP hospitals compared to FPH hospitals and GOV hospitals; by hospitals geographic proximity to the Texas-Mexico border; and by hospital community type (rural, suburban, and urban); and (c) propose specific policy changes that may be needed to improve the current Texas State statute. Methods. In describing the historical and current policy context of NFP hospital legislation in the United States, federal legislation was reviewed from 1913 to the present and Texas State legislation was reviewed from 1980 to the present. In describing the provision of charity care, data from the 2008 Annual Cooperative Hospital Survey were examined by hospital organizational type, size, proximity to the border, and community type using linear regression and chi-squared tests to assess differences in charity care and community benefits. Results. The data included 123 NFP hospitals, 114 GOV hospitals, and 123 FPH. Results. Small sized (p<0.001) and medium sized (p<0.001) NFP hospitals provide a greater percent of total charity care when compared to FPH hospitals and to both GOV and FPH hospitals respectively; however, no significant difference in total charity care was found among large sized NFP hospitals when compared to FPH hospitals alone (p=.345) and both GOV and FPH facilities (p=.214). The amount of charity care provided was not found to be different based on proximity to the border or community type. Community benefit planning and budgeting was found to be similar regardless of community type and proximity to the border. Conclusion. No differences in charity care in Texas were found for large sized NFP hospitals compared to FPH and GOV hospitals. Contrary to widely held beliefs, this study did not find the border region to provide a greater amount of charity care or bad debt. Charity care also did not vary by community type. These findings underscore the need for continued collection of transparent data from all hospitals in order to provide policy makers and consumers with information on utilization trends to ensure benefits are being provided to the community. Policy changes or revoking tax-benefits may occur as charity care utilization declines with the implementation of health reform in the next few years.^

The determinants of improvements in health outcomes and of cost reduction in hospital inpatient care

This study aims to address two research questions. First, ‘Can we identify factors that are determinants both of improved health outcomes and of reduced costs for hospitalized patients with one of six common diagnoses?’ Second, ‘Can we identify other factors that are determinants of improved health outcomes for such hospitalized patients but which are not associated with costs?’ The Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) database from 2003 to 2006 was employed in this study. The total study sample consisted of hospitals which had at least 30 patients each year for the given diagnosis: 954 hospitals for acute myocardial infarction (AMI), 1552 hospitals for congestive heart failure (CHF), 1120 hospitals for stroke (STR), 1283 hospitals for gastrointestinal hemorrhage (GIH), 979 hospitals for hip fracture (HIP), and 1716 hospitals for pneumonia (PNE). This study used simultaneous equations models to investigate the determinants of improvement in health outcomes and of cost reduction in hospital inpatient care for these six common diagnoses. In addition, the study used instrumental variables and two-stage least squares random effect model for unbalanced panel data estimation. The study concluded that a few factors were determinants of high quality and low cost. Specifically, high specialty was the determinant of high quality and low costs for CHF patients; small hospital size was the determinant of high quality and low costs for AMI patients. Furthermore, CHF patients who were treated in Midwest, South, and West region hospitals had better health outcomes and lower hospital costs than patients who were treated in Northeast region hospitals. Gastrointestinal hemorrhage and pneumonia patients who were treated in South region hospitals also had better health outcomes and lower hospital costs than patients who were treated in Northeast region hospitals. This study found that six non-cost factors were related to health outcomes for a few diagnoses: hospital volume, percentage emergency room admissions for a given diagnosis, hospital competition, specialty, bed size, and hospital region.^

Assessing the impact of electronic health record technology adoption on hospital labor efficiency

Information technology (IT) in the hospital organization is fast becoming a key asset, particularly in light of recent reform legislation in the United States calling for expanding the role of IT in our health care system. Future payment reductions to hospitals included in current health reform are based on expected improvements in hospital operating efficiency. Since over half of hospital expenses are for labor, improved efficiency in use of labor resources can be critical in meeting this challenge. Policy makers have touted the value of IT investments to improve efficiency in response to payment reductions. ^ This study was the first to directly examine the relationship between electronic health record (EHR) technology and staffing efficiency in hospitals. As the hospital has a myriad of outputs for inpatient and outpatient care, efficiency was measured using an industry standard performance metric – full time equivalent employees per adjusted occupied bed (FTE/AOB). Three hypotheses were tested in this study.^ To operationalize EHR technology adoption, we developed three constructs to model adoption, each of which was tested by separate hypotheses. The first hypothesis that a larger number of EHR applications used by a hospital would be associated with greater staffing efficiency (or lower values of FTE/AOB) was not accepted. Association between staffing efficiency and specific EHR applications was the second hypothesis tested and accepted with some applications showing significant impacts on observed values for FTE/AOB. Finally, the hypothesis that the longer an EHR application was used in a hospital would be associated with greater labor efficiency was not accepted as the model showed few statistically significant relationships to FTE/AOB performance. Generally, there does not appear a strong relationship between EHR usage and improved labor efficiency in hospitals.^ While returns on investment from EHR usage may not come from labor efficiencies, they may be better sought using measures of quality, contribution to an efficient and effective local health care system, and improved customer satisfaction through greater patient throughput.^

Effect of primary care availability and health insurance coverage on risk and cost of Preventable Hospitalizations in Harris County

Preventable Hospitalizations (PHs) are hospitalizations that can be avoided with appropriate and timely care in the ambulatory setting and hence are closely associated with primary care access in a community. Increased primary care availability and health insurance coverage may increase primary care access, and consequently may be significantly associated with risks and costs of PHs. Objective. To estimate the risk and cost of preventable hospitalizations (PHs); to determine the association of primary care availability and health insurance coverage with the risk and costs of PHs, first alone and then simultaneously; and finally, to estimate the impact of expansions in primary care availability and health insurance coverage on the burden of PHs among non-elderly adult residents of Harris County. Methods. The study population was residents of Harris County, age 18 to 64, who had at least one hospital discharge in a Texas hospital in 2008. The primary independent variables were availability of primary care physicians, availability of primary care safety net clinics and health insurance coverage. The primary dependent variables were PHs and associated hospitalization costs. The Texas Health Care Information Collection (THCIC) Inpatient Discharge data was used to obtain information on the number and costs of PHs in the study population. Risk of PHs in the study population, as well as average and total costs of PHs were calculated. Multivariable logistic regression models and two-step Heckman regression models with log-transformed costs were used to determine the association of primary care availability and health insurance coverage with the risk and costs of PHs respectively, while controlling for individual predisposing, enabling and need characteristics. Predicted PH risk and cost were used to calculate the predicted burden of PHs in the study population and the impact of expansions in primary care availability and health insurance coverage on the predicted burden. Results. In 2008, hospitalized non-elderly adults in Harris County had 11,313 PHs and a corresponding PH risk of 8.02%. Congestive heart failure was the most common PH. PHs imposed a total economic burden of $84 billion at an average of $7,449 per PH. Higher primary care safety net availability was significantly associated with the lower risk of PHs in the final risk model, but only in the uninsured. A unit increase in safety net availability led to a 23% decline in PH odds in the uninsured, compared to only a 4% decline in the insured. Higher primary care physician availability was associated with increased PH costs in the final cost model (β=0.0020; p<0.05). Lack of health insurance coverage increased the risk of PH, with the uninsured having 30% higher odds of PHs (OR=1.299; p<0.05), but reduced the cost of a PH by 7% (β=-0.0668; p<0.05). Expansions in primary care availability and health insurance coverage were associated with a reduction of about $1.6 million in PH burden at the highest level of expansion. Conclusions. Availability of primary care resources and health insurance coverage in hospitalized non-elderly adults in Harris County are significantly associated with the risk and costs of PHs. Expansions in these primary care access factors can be expected to produce significant reductions in the burden of PHs in Harris County.^

Global practice experience: A useful lens for understanding patient and staff perceptions of successful integration of health information technology in primary care

Making healthcare comprehensive and more efficient remains a complex challenge. Health Information Technology (HIT) is recognized as an important component of this transformation but few studies describe HIT adoption and it's effect on the bedside experience by physicians, staff and patients. This study applied descriptive statistics and correlation analysis to data from the Patient-Centered Medical Home National Demonstration Project (NDP) of the American Academy of Family Physicians. Thirty-six clinics were followed for 26 months by clinician/staff questionnaires and patient surveys. This study characterizes those clinics as well as staff and patient perspectives on HIT usefulness, the doctor-patient relationship, electronic medical record (EMR) implementation, and computer connections in the practice throughout the study. The Global Practice Experience factor, a composite score related to key components of primary care, was then correlated to clinician and patient perspectives. This study found wide adoption of HIT among NDP practices. Patient perspectives on HIT helpfulness on the doctor-patient showed a suggestive trend that approached statistical significance (p = 0.172). Clinicians and staff noted successful integration of EMR into clinic workflow and their perception of helpfulness to the doctor-patient relationship show a suggestive increase also approaching statistical significance (p=0.06). GPE was correlated with clinician/staff assessment of a helpful doctor-patient relationship midway through the study (R 0.460, p = 0.021) with the remaining time points nearing statistical significance. GPE was also correlated to both patient perspectives of EMR helpfulness in the doctor-patient relationship (R 0.601, p = 0.001) and computer connections (R 0.618, p = 0.0001) at the start of the study. ^

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Packages of interventions for family planning, safe abortion care, maternal, newborn and child health

The evidence shows that high maternal, perinatal, neonatal and child mortality rates are associated with inadequate and poor quality health services. Evidence also suggests that explicit, evidence-based, cost effective packages of interventions can improve the processes and outcomes of health care when appropriately implemented. This document describes the key effective interventions organized in packages across the continuum of care through pre-pregnancy, pregnancy, childbirth, postpartum, newborn care and care of the child. The packages are defined for community and/or facility levels in developing countries and provide guidance on the essential components needed to assure adequacy and quality of care

Indian Patent Policy and Publich Health : implications from the Japanese Experience

The introduction of pharmaceutical product patents in India and other developing countries is expected to have a significant effect on public health and local pharmaceutical industries. This paper draws implications from the historical experience of Japan when it introduced product patents in 1976. In Japan, narrow patents and promotion of cross-licensing were effective tools to keep drug prices in check while ensuring the introduction of new drugs. While the global pharmaceutical market surrounding India today differs considerably from that of the 1970's, the Japanese experience offers a policy option that may profitably be considered by India today. The Indian patent system emphasizes the patentability requirement in contrast to the Japanese patent policy which relied on narrow patents and extensive licensing. R&D by local firms and the development of local products may be promoted more effectively under the Japanese model.

Service needs forecasting: an approach for the automotive industry using analogies with medical ER management models.

During the past years, the industry has shifted position and moved towards “the luxury universe” whose customers are demanding, treating individuals as unique and valued customer for the business, offering vehicles produced with the state of the art technologies and implementing the highest finishing standards. Due to the competitive level in the market, car makers enable processes which equalizes customer services to E.R. management, being dealt with the maximum urgency that allows the comparison between both, car workshops and emergency rooms, where workshop bays or ramps will be equal to emergency boxes and skilled technicians are equivalent to the health care specialist, who will carry out tests and checks prior to afford any final operation, keeping the “patient” under control before it is back to normal utilization. This paper establishes a valid model for the automotive industry to estimate customer service demand forecasting under variable demand conditions using analogies with patient demand models used for the medical ER.

SERVICE NEEDS FORECASTING: An Approach for the Motor Industry Using Analogies with Medical ER Management Models.

During the past years, the industry has shifted position and moved towards “the luxury universe” whose customers are demanding, treating individuals as unique and valued customer for the business, offering vehicles produced with the state of the art technologies and implementing the highest finishing standards. Due to the competitive level in the market, motor makers enable processes which equalizes customer services to E.R. management, being dealt with the maximum urgency that allows the comparison between both, car workshops and emergency rooms, where workshop bays or ramps will be equal to emergency boxes and skilled technicians are equivalent to the health care specialist, who will carry out tests and checks prior to afford any final operation, keeping the “patient” under control before it is back to normal utilization. This paper ratify a valid model for the automotive industry to estimate customer service demand forecasting under variable demand conditions using analogies with patient demand models used for the medical ER

A model to develop a platform for personalised health applications

Antecedentes Europa vive una situación insostenible. Desde el 2008 se han reducido los recursos de los gobiernos a raíz de la crisis económica. El continente Europeo envejece con ritmo constante al punto que se prevé que en 2050 habrá sólo dos trabajadores por jubilado [54]. A esta situación se le añade el aumento de la incidencia de las enfermedades crónicas, relacionadas con el envejecimiento, cuyo coste puede alcanzar el 7% del PIB de un país [51]. Es necesario un cambio de paradigma. Una nueva manera de cuidar de la salud de las personas: sustentable, eficaz y preventiva más que curativa. Algunos estudios abogan por el cuidado personalizado de la salud (pHealth). En este modelo las prácticas médicas son adaptadas e individualizadas al paciente, desde la detección de los factores de riesgo hasta la personalización de los tratamientos basada en la respuesta del individuo [81]. El cuidado personalizado de la salud está asociado a menudo al uso de las tecnologías de la información y comunicación (TICs) que, con su desarrollo exponencial, ofrecen oportunidades interesantes para la mejora de la salud. El cambio de paradigma hacia el pHealth está lentamente ocurriendo, tanto en el ámbito de la investigación como en la industria, pero todavía no de manera significativa. Existen todavía muchas barreras relacionadas a la economía, a la política y la cultura. También existen barreras puramente tecnológicas, como la falta de sistemas de información interoperables [199]. A pesar de que los aspectos de interoperabilidad están evolucionando, todavía hace falta un diseño de referencia especialmente direccionado a la implementación y el despliegue en gran escala de sistemas basados en pHealth. La presente Tesis representa un intento de organizar la disciplina de la aplicación de las TICs al cuidado personalizado de la salud en un modelo de referencia, que permita la creación de plataformas de desarrollo de software para simplificar tareas comunes de desarrollo en este dominio. Preguntas de investigación RQ1 >Es posible definir un modelo, basado en técnicas de ingeniería del software, que represente el dominio del cuidado personalizado de la salud de una forma abstracta y representativa? RQ2 >Es posible construir una plataforma de desarrollo basada en este modelo? RQ3 >Esta plataforma ayuda a los desarrolladores a crear sistemas pHealth complejos e integrados? Métodos Para la descripción del modelo se adoptó el estándar ISO/IEC/IEEE 42010por ser lo suficientemente general y abstracto para el amplio enfoque de esta tesis [25]. El modelo está definido en varias partes: un modelo conceptual, expresado a través de mapas conceptuales que representan las partes interesadas (stakeholders), los artefactos y la información compartida; y escenarios y casos de uso para la descripción de sus funcionalidades. El modelo fue desarrollado de acuerdo a la información obtenida del análisis de la literatura, incluyendo 7 informes industriales y científicos, 9 estándares, 10 artículos en conferencias, 37 artículos en revistas, 25 páginas web y 5 libros. Basándose en el modelo se definieron los requisitos para la creación de la plataforma de desarrollo, enriquecidos por otros requisitos recolectados a través de una encuesta realizada a 11 ingenieros con experiencia en la rama. Para el desarrollo de la plataforma, se adoptó la metodología de integración continua [74] que permitió ejecutar tests automáticos en un servidor y también desplegar aplicaciones en una página web. En cuanto a la metodología utilizada para la validación se adoptó un marco para la formulación de teorías en la ingeniería del software [181]. Esto requiere el desarrollo de modelos y proposiciones que han de ser validados dentro de un ámbito de investigación definido, y que sirvan para guiar al investigador en la búsqueda de la evidencia necesaria para justificarla. La validación del modelo fue desarrollada mediante una encuesta online en tres rondas con un número creciente de invitados. El cuestionario fue enviado a 134 contactos y distribuido en algunos canales públicos como listas de correo y redes sociales. El objetivo era evaluar la legibilidad del modelo, su nivel de cobertura del dominio y su potencial utilidad en el diseño de sistemas derivados. El cuestionario incluía preguntas cuantitativas de tipo Likert y campos para recolección de comentarios. La plataforma de desarrollo fue validada en dos etapas. En la primera etapa se utilizó la plataforma en un experimento a pequeña escala, que consistió en una sesión de entrenamiento de 12 horas en la que 4 desarrolladores tuvieron que desarrollar algunos casos de uso y reunirse en un grupo focal para discutir su uso. La segunda etapa se realizó durante los tests de un proyecto en gran escala llamado HeartCycle [160]. En este proyecto un equipo de diseñadores y programadores desarrollaron tres aplicaciones en el campo de las enfermedades cardio-vasculares. Una de estas aplicaciones fue testeada en un ensayo clínico con pacientes reales. Al analizar el proyecto, el equipo de desarrollo se reunió en un grupo focal para identificar las ventajas y desventajas de la plataforma y su utilidad. Resultados Por lo que concierne el modelo que describe el dominio del pHealth, la parte conceptual incluye una descripción de los roles principales y las preocupaciones de los participantes, un modelo de los artefactos TIC que se usan comúnmente y un modelo para representar los datos típicos que son necesarios formalizar e intercambiar entre sistemas basados en pHealth. El modelo funcional incluye un conjunto de 18 escenarios, repartidos en: punto de vista de la persona asistida, punto de vista del cuidador, punto de vista del desarrollador, punto de vista de los proveedores de tecnologías y punto de vista de las autoridades; y un conjunto de 52 casos de uso repartidos en 6 categorías: actividades de la persona asistida, reacciones del sistema, actividades del cuidador, \engagement" del usuario, actividades del desarrollador y actividades de despliegue. Como resultado del cuestionario de validación del modelo, un total de 65 personas revisó el modelo proporcionando su nivel de acuerdo con las dimensiones evaluadas y un total de 248 comentarios sobre cómo mejorar el modelo. Los conocimientos de los participantes variaban desde la ingeniería del software (70%) hasta las especialidades médicas (15%), con declarado interés en eHealth (24%), mHealth (16%), Ambient Assisted Living (21%), medicina personalizada (5%), sistemas basados en pHealth (15%), informática médica (10%) e ingeniería biomédica (8%) con una media de 7.25_4.99 años de experiencia en estas áreas. Los resultados de la encuesta muestran que los expertos contactados consideran el modelo fácil de leer (media de 1.89_0.79 siendo 1 el valor más favorable y 5 el peor), suficientemente abstracto (1.99_0.88) y formal (2.13_0.77), con una cobertura suficiente del dominio (2.26_0.95), útil para describir el dominio (2.02_0.7) y para generar sistemas más específicos (2_0.75). Los expertos también reportan un interés parcial en utilizar el modelo en su trabajo (2.48_0.91). Gracias a sus comentarios, el modelo fue mejorado y enriquecido con conceptos que faltaban, aunque no se pudo demonstrar su mejora en las dimensiones evaluadas, dada la composición diferente de personas en las tres rondas de evaluación. Desde el modelo, se generó una plataforma de desarrollo llamada \pHealth Patient Platform (pHPP)". La plataforma desarrollada incluye librerías, herramientas de programación y desarrollo, un tutorial y una aplicación de ejemplo. Se definieron cuatro módulos principales de la arquitectura: el Data Collection Engine, que permite abstraer las fuentes de datos como sensores o servicios externos, mapeando los datos a bases de datos u ontologías, y permitiendo interacción basada en eventos; el GUI Engine, que abstrae la interfaz de usuario en un modelo de interacción basado en mensajes; y el Rule Engine, que proporciona a los desarrolladores un medio simple para programar la lógica de la aplicación en forma de reglas \if-then". Después de que la plataforma pHPP fue utilizada durante 5 años en el proyecto HeartCycle, 5 desarrolladores fueron reunidos en un grupo de discusión para analizar y evaluar la plataforma. De estas evaluaciones se concluye que la plataforma fue diseñada para encajar las necesidades de los ingenieros que trabajan en la rama, permitiendo la separación de problemas entre las distintas especialidades, y simplificando algunas tareas de desarrollo como el manejo de datos y la interacción asíncrona. A pesar de ello, se encontraron algunos defectos a causa de la inmadurez de algunas tecnologías empleadas, y la ausencia de algunas herramientas específicas para el dominio como el procesado de datos o algunos protocolos de comunicación relacionados con la salud. Dentro del proyecto HeartCycle la plataforma fue utilizada para el desarrollo de la aplicación \Guided Exercise", un sistema TIC para la rehabilitación de pacientes que han sufrido un infarto del miocardio. El sistema fue testeado en un ensayo clínico randomizado en el cual a 55 pacientes se les dio el sistema para su uso por 21 semanas. De los resultados técnicos del ensayo se puede concluir que, a pesar de algunos errores menores prontamente corregidos durante el estudio, la plataforma es estable y fiable. Conclusiones La investigación llevada a cabo en esta Tesis y los resultados obtenidos proporcionan las respuestas a las tres preguntas de investigación que motivaron este trabajo: RQ1 Se ha desarrollado un modelo para representar el dominio de los sistemas personalizados de salud. La evaluación hecha por los expertos de la rama concluye que el modelo representa el dominio con precisión y con un balance apropiado entre abstracción y detalle. RQ2 Se ha desarrollado, con éxito, una plataforma de desarrollo basada en el modelo. RQ3 Se ha demostrado que la plataforma es capaz de ayudar a los desarrolladores en la creación de software pHealth complejos. Las ventajas de la plataforma han sido demostradas en el ámbito de un proyecto de gran escala, aunque el enfoque genérico adoptado indica que la plataforma podría ofrecer beneficios también en otros contextos. Los resultados de estas evaluaciones ofrecen indicios de que, ambos, el modelo y la plataforma serán buenos candidatos para poderse convertir en una referencia para futuros desarrollos de sistemas pHealth. ABSTRACT Background Europe is living in an unsustainable situation. The economic crisis has been reducing governments' economic resources since 2008 and threatening social and health systems, while the proportion of older people in the European population continues to increase so that it is foreseen that in 2050 there will be only two workers per retiree [54]. To this situation it should be added the rise, strongly related to age, of chronic diseases the burden of which has been estimated to be up to the 7% of a country's gross domestic product [51]. There is a need for a paradigm shift, the need for a new way of caring for people's health, shifting the focus from curing conditions that have arisen to a sustainable and effective approach with the emphasis on prevention. Some advocate the adoption of personalised health care (pHealth), a model where medical practices are tailored to the patient's unique life, from the detection of risk factors to the customization of treatments based on each individual's response [81]. Personalised health is often associated to the use of Information and Communications Technology (ICT), that, with its exponential development, offers interesting opportunities for improving healthcare. The shift towards pHealth is slowly taking place, both in research and in industry, but the change is not significant yet. Many barriers still exist related to economy, politics and culture, while others are purely technological, like the lack of interoperable information systems [199]. Though interoperability aspects are evolving, there is still the need of a reference design, especially tackling implementation and large scale deployment of pHealth systems. This thesis contributes to organizing the subject of ICT systems for personalised health into a reference model that allows for the creation of software development platforms to ease common development issues in the domain. Research questions RQ1 Is it possible to define a model, based on software engineering techniques, for representing the personalised health domain in an abstract and representative way? RQ2 Is it possible to build a development platform based on this model? RQ3 Does the development platform help developers create complex integrated pHealth systems? Methods As method for describing the model, the ISO/IEC/IEEE 42010 framework [25] is adopted for its generality and high level of abstraction. The model is specified in different parts: a conceptual model, which makes use of concept maps, for representing stakeholders, artefacts and shared information, and in scenarios and use cases for the representation of the functionalities of pHealth systems. The model was derived from literature analysis, including 7 industrial and scientific reports, 9 electronic standards, 10 conference proceedings papers, 37 journal papers, 25 websites and 5 books. Based on the reference model, requirements were drawn for building the development platform enriched with a set of requirements gathered in a survey run among 11 experienced engineers. For developing the platform, the continuous integration methodology [74] was adopted which allowed to perform automatic tests on a server and also to deploy packaged releases on a web site. As a validation methodology, a theory building framework for SW engineering was adopted from [181]. The framework, chosen as a guide to find evidence for justifying the research questions, imposed the creation of theories based on models and propositions to be validated within a scope. The validation of the model was conducted as an on-line survey in three validation rounds, encompassing a growing number of participants. The survey was submitted to 134 experts of the field and on some public channels like relevant mailing lists and social networks. Its objective was to assess the model's readability, its level of coverage of the domain and its potential usefulness in the design of actual, derived systems. The questionnaires included quantitative Likert scale questions and free text inputs for comments. The development platform was validated in two scopes. As a small-scale experiment, the platform was used in a 12 hours training session where 4 developers had to perform an exercise consisting in developing a set of typical pHealth use cases At the end of the session, a focus group was held to identify benefits and drawbacks of the platform. The second validation was held as a test-case study in a large scale research project called HeartCycle the aim of which was to develop a closed-loop disease management system for heart failure and coronary heart disease patients [160]. During this project three applications were developed by a team of programmers and designers. One of these applications was tested in a clinical trial with actual patients. At the end of the project, the team was interviewed in a focus group to assess the role the platform had within the project. Results For what regards the model that describes the pHealth domain, its conceptual part includes a description of the main roles and concerns of pHealth stakeholders, a model of the ICT artefacts that are commonly adopted and a model representing the typical data that need to be formalized among pHealth systems. The functional model includes a set of 18 scenarios, divided into assisted person's view, caregiver's view, developer's view, technology and services providers' view and authority's view, and a set of 52 Use Cases grouped in 6 categories: assisted person's activities, system reactions, caregiver's activities, user engagement, developer's activities and deployer's activities. For what concerns the validation of the model, a total of 65 people participated in the online survey providing their level of agreement in all the assessed dimensions and a total of 248 comments on how to improve and complete the model. Participants' background spanned from engineering and software development (70%) to medical specialities (15%), with declared interest in the fields of eHealth (24%), mHealth (16%), Ambient Assisted Living (21%), Personalized Medicine (5%), Personal Health Systems (15%), Medical Informatics (10%) and Biomedical Engineering (8%) with an average of 7.25_4.99 years of experience in these fields. From the analysis of the answers it is possible to observe that the contacted experts considered the model easily readable (average of 1.89_0.79 being 1 the most favourable scoring and 5 the worst), sufficiently abstract (1.99_0.88) and formal (2.13_0.77) for its purpose, with a sufficient coverage of the domain (2.26_0.95), useful for describing the domain (2.02_0.7) and for generating more specific systems (2_0.75) and they reported a partial interest in using the model in their job (2.48_0.91). Thanks to their comments, the model was improved and enriched with concepts that were missing at the beginning, nonetheless it was not possible to prove an improvement among the iterations, due to the diversity of the participants in the three rounds. From the model, a development platform for the pHealth domain was generated called pHealth Patient Platform (pHPP). The platform includes a set of libraries, programming and deployment tools, a tutorial and a sample application. The main four modules of the architecture are: the Data Collection Engine, which allows abstracting sources of information like sensors or external services, mapping data to databases and ontologies, and allowing event-based interaction and filtering, the GUI Engine, which abstracts the user interface in a message-like interaction model, the Workow Engine, which allows programming the application's user interaction ows with graphical workows, and the Rule Engine, which gives developers a simple means for programming the application's logic in the form of \if-then" rules. After the 5 years experience of HeartCycle, partially programmed with pHPP, 5 developers were joined in a focus group to discuss the advantages and drawbacks of the platform. The view that emerged from the training course and the focus group was that the platform is well-suited to the needs of the engineers working in the field, it allowed the separation of concerns among the different specialities and it simplified some common development tasks like data management and asynchronous interaction. Nevertheless, some deficiencies were pointed out in terms of a lack of maturity of some technological choices, and for the absence of some domain-specific tools, e.g. for data processing or for health-related communication protocols. Within HeartCycle, the platform was used to develop part of the Guided Exercise system, a composition of ICT tools for the physical rehabilitation of patients who suffered from myocardial infarction. The system developed using the platform was tested in a randomized controlled clinical trial, in which 55 patients used the system for 21 weeks. The technical results of this trial showed that the system was stable and reliable. Some minor bugs were detected, but these were promptly corrected using the platform. This shows that the platform, as well as facilitating the development task, can be successfully used to produce reliable software. Conclusions The research work carried out in developing this thesis provides responses to the three three research questions that were the motivation for the work. RQ1 A model was developed representing the domain of personalised health systems, and the assessment of experts in the field was that it represents the domain accurately, with an appropriate balance between abstraction and detail. RQ2 A development platform based on the model was successfully developed. RQ3 The platform has been shown to assist developers create complex pHealth software. This was demonstrated within the scope of one large-scale project, but the generic approach adopted provides indications that it would offer benefits more widely. The results of these evaluations provide indications that both the model and the platform are good candidates for being a reference for future pHealth developments.

A guide for providers of mental health and addictive disorder services in managed care contracting /

Shipping list no.: 99-0117-P.