BACKGROUND: Patient reported outcomes (PROs) are important cancer outcomes that can be measured electronically but are understudied in the safety-net hospital setting. Routine electronic screening to address social determinants of health (SDH) has been established in primary care clinics and the emergency department of New England’s largest safety-net hospital. The burden of SDH in safety-net oncology patients is less well-studied. This study aimed to determine the feasibility and challenges of routine administration of ePROMs in a safety-net Radiation Oncology clinic, describe treatment toxicities and quality of life (QOL) experienced by this vulnerable population during radiotherapy, and evaluate SDH and the need for SDH screening in the oncology clinic. METHODS: Patients with lung or head and neck cancer scheduled for radiation oncology consultation from 3/2019–1/2020 were deemed eligible for electronic questionnaire participation based on primary language spoken and absence of metastases. At consultation, patients were administered a set of baseline ePROMs (EQ-5D-3L, FACT, PRO-CTCAE) and a social needs screener (THRIVE) using a widely-used cloud-based, patient-centered outcomes platform. Associations between patient demographics and questionnaire completion were retrospectively evaluated. The set of ePROMs were collected at the end of treatment to characterize treatment-related toxicities and changes in self-reported QOL. RESULTS: In total, 99 eligible head and neck cancer (51.5%) and lung cancer (48.5%) patients were identified. Median age was 65. The majority of patients were male (71.7%), and English-speaking (82.8%). Whites, Blacks, and Asians/Others comprised 42.4%, 38.4%, and 6.1% of patients, respectively. Fifteen patients were Hispanic (15.2%). Patients were most likely to have private health insurance (39.4%), followed by joint Medicare-Medicaid (25.3%), Medicaid (17.2%), and Medicare (16.2%). Two patients were insured by Corrections (2.0%). Eight patients (8.1%) no-showed or cancelled, while 91 patients were seen in consultation. Forty-four patients (48.4%) completed the initial questionnaires. For the remaining 47 patients (51.6%), the most common reason for lack of ePROM completion was clinic understaffing and/or clinical decision based on the absence of indication for radiotherapy (n=27, 57.4%). Ten patients refused to complete questionnaires (21.3%), with reasons cited including length of questionnaires and low energy. Ten patients were physically unable to attempt questionnaires (21.3%), for reasons including disabilities and low-literacy. Age, language, race, ethnicity, insurance, marital status, gender, and disease site were not significantly associated with ePROM completion (P≥0.05). For patients who completed the general (QOL) questionnaire EQ-5D-3L, there was no significant difference in general QOL domains nor self-reported overall health score at baseline vs. end of treatment. For head and neck cancer patients, FACT-H&N Total scores, measuring disease-specific QOL, were significantly worse at end of treatment vs. baseline (P=0.006). For lung cancer patients, FACT-L Total scores at the end of radiation treatment were not significantly worse at end of treatment vs. baseline (P=0.953). For head and neck cancer patients who completed PRO-CTCAE, there was a significant increase in the number with moderate to very severe taste issues (P=0.008) and decrease in appetite (P=0.025) by end of treatment. For lung cancer patients, there was a trend towards an increase in the number reporting moderate to very severe nausea (P=0.083). Eighty-one of 99 patients (81.8%) were screened for at least one SDH domain using the THRIVE screener at the study hospital. Nineteen patients (19.1%) had all 8 THRIVE social determinants of health statuses documented. Only housing status was documented for 61 patients (61.6%). There was a trend for married individuals (P=0.068) and females (P=0.074) to be associated with the completion of at least one THRIVE domain. Age, race, language, and insurance status were not associated with THRIVE screening (P>0.05). Transportation to appointments (21.1%), food insecurity (20%), and affording medications (10.5%) were the most prevalent concerns among these oncology patients, with 100% of patients who reported insecurities with medication and transportation requesting resources for these needs. CONCLUSION: Routine ePROs collection in a busy safety-net oncology setting is feasible, but challenging and labor-intensive. Implementation was met with both patient and staff challenges and revealed the need for dedicated project management, staff training, and opportunities to increase patient accessibility. Preliminary PROs analyses revealed several significant detriments in quality of life and increased symptoms for this patient population during treatment, but additional data collection is required. Safety-net oncology patients report significant social needs. Routine SDH screening and resource referral should be considered in these vulnerable patients. Efforts in a specialized department such as Radiation Oncology could fill gaps in existing efforts in a large safety-net hospital. Safety-net oncology clinics can likely help vulnerable cancer patients access available community resources and reduce disparities due to SDH.

Chronic low back pain (CLBP) is a nonspecific and persistent ailment that entails many physiological, psychological, social, and economic consequences for individuals and societies. Although there is a plethora of treatments available to treat CLBP, each treatment has varying efficacy for different patients, and it is currently unknown how to best link patients to their ideal treatment. However, it is known that biopsychosocial influences associated with CLBP affect the way that we move. It has been hypothesized that identifying phenotypes of spinal motion could facilitate an objective and repeatable method of determining the optimal treatment for each patient. The objective of this research was to develop an array of high deflection strain gauges to monitor spinal motion, and use that information to identify spinal-motion phenotypes. The high deflection strain gauges used in this endeavor exhibit highly nonlinear electrical signal due to their viscoelastic material properties. Two sub-models were developed to account for these nonlinearities: the first characterizes the relationship between quasistatic strain and resistance, and the second accounts for transient electrical phenomena due to the viscoelastic response to dynamic loads. These sub-models are superimposed to predict and interpret the electrical signal under a wide range of applications. The combined model accurately predicts sensor strain with a mean absolute error (MAE) of 1.4% strain and strain rate with an MAE of 0.036 mm/s. Additionally, a multilayered architecture was developed for the strain gauges to provide mechanical support during high strain, cyclic loads. The architecture significantly mitigates sensor creep and viscoplastic deformation, thereby reducing electrical signal drift by 74%. This research also evaluates the effects of CLBP on patient-reported outcomes. An exploratory factor analysis revealed that there are five primary components of well-being: Pain and Physical Limitations, Psychological Distress, Physical Activity, Sleep Deprivation, and Pain Catastrophizing. The presence of CLBP has adverse effects on all these components. It was also observed that different patient reported outcomes are highly correlated with each other, and the presence of CLBP is a significant moderating factor in many of these relationships. Arrays of high-deflection strain gauges were used to collect spinal kinematic data from 274 subjects. Seven phenotypes of spinal motion were identified among study participants. Statistical analyses revealed significant differences in the patient-reported outcomes of subjects who exhibited different phenotypes. This is a promising indication that the phenotypes may also provide important information to clinicians who treat patients suffering from CLBP. Future research will be conducted to develop and identify the optimal treatments for patients according to their phenotypes, which has the potential to reduce medical costs, expedite recovery, and improve the lives of millions of patients worldwide.

BACKGROUND:Available measures of patient-reported outcomes for complementary and alternative medicine (CAM) inadequately capture the range of patient-reported treatment effects. The Self-Assessment of Change questionnaire was developed to measure multi-dimensional shifts in well-being for CAM users. With content derived from patient narratives, items were subsequently focused through interviews on a new cohort of participants. Here we present the development of the final version in which the content and format is refined through cognitive interviews.METHODS:We conducted cognitive interviews across five iterations of questionnaire refinement with a culturally diverse sample of 28 CAM users. In each iteration, participant critiques were used to revise the questionnaire, which was then re-tested in subsequent rounds of cognitive interviews. Following all five iterations, transcripts of cognitive interviews were systematically coded and analyzed to examine participants' understanding of the format and content of the final questionnaire. Based on this data, we established summary descriptions and selected exemplar quotations for each word pair on the final questionnaire.RESULTS:The final version of the Self-Assessment of Change questionnaire (SAC) includes 16 word pairs, nine of which remained unchanged from the original draft. Participants consistently said that these stable word pairs represented opposite ends of the same domain of experience and the meanings of these terms were stable across the participant pool. Five pairs underwent revision and two word pairs were added. Four word pairs were eliminated for redundancy or because participants did not agree on the meaning of the terms. Cognitive interviews indicate that participants understood the format of the questionnaire and considered each word pair to represent opposite poles of a shared domain of experience.CONCLUSIONS:We have placed lay language and direct experience at the center of questionnaire revision and refinement. In so doing, we provide an innovative model for the development of truly patient-centered outcome measures. Although this instrument was designed and tested in a CAM-specific population, it may be useful in assessing multi-dimensional shifts in well-being across a broader patient population.

Introduction: There has been a continuous development of new technologies in healthcare that are derived from national quality registries. However, this innovation needs to be translated into the workflow of healthcare delivery, to enable children with long-term conditions to get the best support possible to manage their health during everyday life. Since children living with long-term conditions experience different interference levels in their lives, healthcare professionals need to assess the impact of care on children’s day-to-day lives, as a complement to biomedical assessments. Aim: The overall aim of this thesis was to explore and describe the use of instruments about health-related quality of life (HRQOL) in outpatient care for children with long-term conditions on the basis of a national quality registry system. Methods: The research was conducted by using comparative, cross-sectional and explorative designs and data collection was performed by using different methods. The questionnaire DISABKIDS Chronic Generic Measure -37 was used as well as semi-structured interviews and video-recordings from consultations. Altogether, 156 children (8–18 years) and nine healthcare professionals participated in the studies. Children with Type 1 Diabetes (T1D) (n 131) answered the questionnaire DISABKIDS and children with rheumatic diseases, kidney diseases and T1D (n 25) were interviewed after their consultation at the outpatient clinic after the web-DISABKIDS had been used. In total, nine healthcare professionals used the HRQOL instrument as an assessment tool during the encounters which was video-recorded (n 21). Quantitative deductive content analysis was used to describe content in different HRQOL instruments. Statistical inference was used to analyse results from DISABKIDS and qualitative content analysis was used to analyse the interviews and video-recordings. Results: The findings showed that based on a biopsychosocial perspective, both generic and disease-specific instruments should be used to gain a comprehensive evaluation of the child’s HRQOL. The DISABKIDS instrument is applicable when describing different aspects of health concerning children with T1D. When DISABKIDS was used in the encounters, children expressed positive experiences about sharing their results with the healthcare professional. It was discovered that different approaches led to different outcomes for the child when the healthcare professionals were using DISABKIDS during the encounter. When an instructing approach is used, the child’s ability to learn more about their health and how to improve their health is limited. When an inviting or engaging approach is used by the professional, the child may become more involved during the conversations. Conclusions: It could be argued that instruments of HRQOL could be used as a complement to biomedical variables, to promote a biopsychosocial perspective on the child’s health. According to the children in this thesis, feedback on their results after answering to web-DISABKIDS is important, which implies that healthcare professionals need to prioritize time for discussions about results from HRQOL instruments in the encounters. If healthcare professionals involve the child in the discussion of the results of the HRQOL, misinterpreted answers could be corrected during the conversation. Concurrently, this claims that healthcare professionals invite and engage the child.

The Patient Reported Outcomes Measurement Information System (PROMIS) initiative aims to provide reliable and precise item banks measuring patient-reported outcomes in different health domains.The aimof the present work was to provide a German translation of the PROMIS itembanks for satisfaction with participation and to psychometrically test these German versions. Cognitive interviews followed a forward–backward translation. Distribution characteristics, unidimensionality, Rasch model fit, reliability, construct validity, and internal responsiveness were tested in 262 patients with chronic low back pain undergoing rehabilitation. Results for the final 13- and 10-item

No description available.

Contexte : Les neuroleptiques sont souvent prescrits chez les sujets âgés et les patients souffrant de schizophrénie qui sont des personnes vulnérables. Notre objectif était d’étudier l’impact des NLP en situation réelle de prescription, dans ces deux populations. Etude 1. Consommation de neuroleptiques et décès en période de canicule chez les sujets âgés. A partir de données de l’Assurance Maladie, nous avons comparé les prescriptions de NLP chez des sujets âgés décédés pendant la canicule d’août 2003 (n=11624) aux prescriptions de témoins non décédés. Nous avons mis en évidence une association entre risque de décès et consommation de neuroleptiques, que ce soit juste avant ou pendant le pic de canicule et indépendamment d’autres médicaments, d’une démence ou d’une pathologie cardiaque. Etude 2. Efficacité réelle des NLP chez les patients souffrant de schizophrénie. A partir de données d’une cohorte observationnelle ayant inclus en France entière des schizophrènes adultes, nous avons montré que chez les patients déjà traités par NLP (n=5500), il y avait une association entre traitement par antipsychotique atypique (vs. NLP classique) et une meilleure satisfaction avec les soins et ce, pour tous les AA pris en compte et indépendamment du niveau de symptomatologie. Par ailleurs, chez les patients naïfs vis-à-vis de tout NLP et pour qui un traitement était introduit pour la première fois (n=467), un tiers des patients ne s’améliorait pas. Les facteurs prédictifs d’une meilleure réponse clinique étaient une moindre sévérité initiale globale des symptômes et des symptômes négatifs de schizophrénie. Au total, il existait cinq types de trajectoires d’évolution clinique. / Context : Antipsychotic drugs (AD) are often prescribed to elderly people and patients with schizophrenia and both populations are fragile. The aim of the present thesis was to investigate the impact of AD in these patients, in a real-life setting. Study 1. Antipsychotic drug use during a heatwave and risk of death, in older people. Using data from the French Social Security, prescriptions of older people who died during the heatwave in August 2003 (n=11624) were compared to these of controls who survived. An association was evidenced between a prescription of AD and death, in the periods just preceding and during the heatwave, independently of other psychotropic drugs, dementia or cardiac disease. Study 2. Effectiveness of AD in schizophrenia patients. Using data from a French nationwide observational study, we found that in patients treated for schizophrenia (n=5500), a higher level of satisfaction was independently associated with being on second-generation AD as compared to first-generation AD. Also, in drug-naive patients (n=467) followed up during 6 months after a first AD initiation, one third of the patients did not experience any improvement of symptoms. The factors predictive of a better clinical response were lower levels of baseline negative symptoms and overall severity of symptoms. A total of 5 trajectories of clinical evolution were identified.

L’objectif de cette thèse d’articles était de préciser la place respective des mesures objectives (ex., durée et sévérité de la maladie, traitements reçus) et subjectives (ex., troubles psychiatriques, personnalité) en tant que déterminants potentiels de dépression, de qualité de vie (QV) et d’addiction à l’alimentation chez des patient(e)s souffrant de cancer du sein ou d’obésité sévère. En nous basant sur des modèles biopsychosociaux issus du modèle de Wilson et Cleary, nous avons démontré que : 1) La dépression était plus fortement associée aux caractéristiques psychopathologiques de l’individu (personnalité, dépression avant traitement) qu’à la sévérité de la maladie ou aux types de traitements reçus ; 2) Les facteurs associés à la QV dépendent de la dimension de QV considérée (association entre mesures objectives et QV physique ; association entre mesures subjectives et toutes les dimensions de QV) ; 3) Les patients obèses souffrant d’addiction à l’alimentation ont une vulnérabilité psychopathologique spécifique. Nos travaux suggèrent qu’en cas de maladie chronique, les mesures subjectives sont des déterminants potentiels importants de la santé / This article thesis aimed to assess risk factors for three different health outcome measures (depression, health-related quality of life and food addiction) in two populations (breast cancer patients and morbidly obese patients), by assessing the relative impact of biological and physiological variables (i.e., disease duration and severity, types of treatment used), and individual and psychological variables (i.e., psychiatric disorders, personality). By proposing and putting to the test several integrative biopsychosocial models based on Wilson and Cleary’s theoretical model, we demonstrated that : 1) Depression after breast cancer treatment is more strongly associated with variables related to the premorbid individual and psychological characteristics (i.e., personality and depression before treatment) than to biological and physiological variables (i.e., disease severity, types of treatment used) ; 2) Risk factors for lower quality of life are different depending on the quality of life dimension considered (e.g., physical, psychological or sexual) : biological and physiological variables are associated with physical quality of life ; individual and psychological factors are associated with all quality of life dimensions ; 3) Obese patients with food addiction exhibit some specific psychopathological risk factors. Our work suggest to systematically assess individual and psychological variables in patients with chronic diseases because these variables are important potential predictors for different health outcomes

Abstract The aim of this thesis was to measure patient reported outcomes, such as health related quality of life and general diabetes knowledge of elderly diabetes mellitus type 2 (DMT2) patients in Slovenia. Patient reported outcomes demonstrate patient perspectives when evaluating the delivery of care. In Slovenia, a new, multidisciplinary model of chronic care was introduced in 2011, which yet needs to demonstrate the efficiency, care improvement and cost reduction. Thus, another aim of the study was to research if multidisciplinary teams in diabetes care are economically viable. To achieve the above, the study was divided into 4 subprojects. Firstly, the general level of diabetes knowledge of elderly DMT2 patients (n=179) was measured. Secondly, the reliability and validity of generic, European Quality of Life- 5 Dimensions (EQ-5D), and disease specific, Audit on Diabetes Dependent Quality of Life (ADDQoL ) instruments were examined. Thirdly, health related quality of life of elderly diabetic patients (n=285) was assessed. Fourthly, the systematic literature review on the cost-effectiveness of multidisciplinary teams was conducted. The data were collected during the period 2011–2012. The main contributions of the current thesis can be summarised as follows: This was the first study to measure general diabetes knowledge of elderly DMT2 patients in Slovenia. The results showed that the place of living does not have an impact neither on diabetes knowledge nor the health related quality of life of these patients. Secondly, a pioneering example of measuring health related quality of life (HRQoL) in elderly diabetic patients in Slovenia, using a validated and reliable instrument (ADDQoL) was provided. A study to evaluate the relationships between diabetic and other co-existing chronic medical conditions on health related quality of life was performed. As part of that study, the reliability and validity of the instruments (EQ-5D and ADDQoL) were measured, and the analysis showed that both instruments are reliable. Thirdly, a systematic way of finding evidence for understanding the cost-effectiveness of multidisciplinary teams was applied. The results of the literature review show weak improvements in the economic outcomes. In general, the thesis contributes to the improved understanding of patient reported outcomes in elderly diabetic patients, which can be a measure in assessing diabetes care program in Slovenia, and offers a basis for a national evaluation of the Model Practices. Furthermore, patient reported outcomes of elderly diabetic patients is important to Slovenian decision makers to identify and implement appropriate interventions for achieving better management of diabetes and ultimately improving the quality of life of diabetes patients. / Tiivistelmä Tutkimuksen tarkoitus oli mitata iäkkäiden tyypin 2 diabetespotilaiden itse ilmoittamia tuloksia, kuten terveyteen liittyvä elämänlaatu ja yleinen diabetekseen liittyvä tietämys Sloveniassa. Tulokset valottavat potilaiden näkökulmaa hoidon arvioinnissa. Sloveniassa otettiin 2011 käyttöön monitieteellinen hoitomalli, jonka tehoa sekä kykyä parantaa hoitoa ja vähentää hoitokustannuksia ei ole osoitettu. Toisena tavoitteena oli selvittää, onko moniammatillisten tiimien käyttö diabeteshoidossa taloudellisesti järkevää. Tutkimus jaettiin neljään osaprojektiin. Ensin mitattiin iäkkäiden tyypin 2 diabetespotilaiden (n=179) yleistä diabetestietämystä. Toiseksi selvitettiin geneerisen European Quality of Life- 5 Dimensions- (EQ-5D) ja diabeteskohtaisen ADDQoL -mittarin luotettavuus ja validiteetti. Kolmanneksi arvioitiin iäkkäiden diabetespotilaiden (n=285) terveyteen liittyvää elämänlaatua. Neljänneksi tehtiin moniammatillisten tiimien kustannus¬tehokkuutta koskeva systemaattinen kirjallisuuskatsaus. Tiedot kerättiin vuosina 2011–2012. Tulokset voidaan tiivistää seuraavasti: Kyseessä oli ensimmäinen tutkimus, jossa mitattiin iäkkäiden tyypin 2 diabetespotilaiden yleistä diabetestietämystä Sloveniassa. Tulosten mukaan asuinpaikka ei vaikuta potilaiden diabetestietämykseen tai terveyteen liittyvään elämänlaatuun. Toiseksi, Sloveniassa toteutettiin pioneerihanke, jossa mitattiin iäkkäiden potilaiden terveyteen liittyvää elämänlaatua (HRQoL) validoidun ja luotettavan instrumentin (ADDQoL) avulla. Tutkimuksessa selvitettiin diabeteksen ja muiden pitkäaikaissairauksien yhteisvaikutusta terveyteen liittyvään elämänlaatuun. Osana tutkimusta selvitettiin instrumenttien (EQ-5D ja ADDQoL) luotettavuus ja validiteetti. Molemmat osoittautuivat luotettaviksi. Kolmanneksi, tutkimuksessa etsittiin systemaattisesti näyttöä moniammatillisten tiimien kustannustehokkuuden arvioimiseksi. Kirjallisuuskatsauksen mukaan taloudellinen tulos paranee vain vähän. Tutkimus lisää tietoa potilaiden ilmoittamista tuloksista iäkkäiden diabetespotilaiden kohdalla, mitä voidaan käyttää diabeteshoito-ohjelman arvioinnissa Sloveniassa sekä mallikäytäntöjen kansallisen arvioinnin perustana. Diabetespotilaiden itse ilmoittava terveystieto on Slovenian päätöksentekijöille tärkeää sopivien interventioiden löytämisessä ja toteuttamisessa, kun halutaan parantaa diabeteshoitoa ja potilaiden elämänlaatua.

Individuals born with primary immune deficiency diseases (PIDD) have a dysfunctional immune system, and many are treated by lifelong injections of immunoglobulin therapy. Studies have shown that these patients have low health-related quality of life (HRQOL) and well-being (WB) and that these outcomes might be improved by the availability of therapy innovated according to preferences for fewer needle sticks or a shorter infusion time. Regulators at the U.S. Food and Drug Administration (FDA) have approved therapies innovated per these preferences. However, there is limited data demonstrating how these innovations impact HRQOL and WB. Using the biopsychosocial model, the purpose of this cross sectional quantitative study was to evaluate whether patients with PIDD using therapies innovated for fewer needle sticks or a shorter infusion time had a higher mean HRQOL and WB compared to those who were not. The study included 153 patients who completed the Patient Reported Outcomes Measurement Information System (PROMIS)-29 survey. The dependent variables were HRQOL and WB measured by PROMIS-29, and the independent variables were the medical product innovations. Independent samples t tests results showed mean PROMIS-29 scores were not statistically different (p > .05). This suggests patients were optimized according to their treatment preference. A subgroup of patients who had taken the PROMIS-29 survey more than once concurrent with switching to a therapy aligned with patient preferences showed improved HRQOL and WB. These findings have implications for positive social change in that seeking the patient's voice to inform medical product innovation and FDA regulatory decision-making has potential to improve biopsychosocial outcomes.