BACKGROUND: Prolonged mechanical ventilation for acute medical conditions increases the risk of chronic critical illness (CCI). Close family members are confronted with the life-threatening condition of the CCI patients and are prone to develop posttraumatic stress disorder affecting their health-related quality of life (HRQL). Main aim of the present study was to investigate patient- and family-related risk factors for posttraumatic stress and decreased HRQL in family members of CCI patients. METHODS: In a cross-sectional design nested within a prospective longitudinal cohort study, posttraumatic stress symptoms and quality of life were assessed in family members of CCI patients (n = 83, aged between 18 and 72 years) up to 6 months after transfer from ICU at acute care hospital to post-acute rehabilitation. Patients admitted a large rehabilitation hospital for ventilator weaning. The Posttraumatic Stress Scale-10 and the Euro-Quality of life-5D-3L were applied in both patients and their family members via telephone interview. RESULTS: A significant proportion of CCI patients and their family members (14.5 and 15.7 %, respectively) showed clinically relevant scores of posttraumatic stress. Both CCI patients and family members reported poorer HRQL than a normative sample. Factors independently associated with posttraumatic stress in family members were the time following ICU discharge (β = .256, 95 % confidence interval .053-.470) and the patients\' diagnosis of PTSD (β = .264, 95 % confidence interval .045-.453). Perceived satisfaction with the relationship turned out to be a protective factor for posttraumatic stress in family members of CCI patients (β = -.231, 95 % confidence interval -.423 to -.015). Regarding HRQL in family members, patients\' acute posttraumatic stress at ICU (β = -.290, 95 % confidence interval -.360 to -.088) and their own posttraumatic stress 3 to 6 months post-transfer (β = -.622, 95 % confidence interval -.640 to -.358) turned out to be significant predictors. CONCLUSIONS: Posttraumatic stress and HRQL should be routinely assessed in family members of CCI patients at regular intervals starting early at ICU. Preventive family-centered interventions are needed to improve posttraumatic stress and HRQL in both patients and their family members.

BACKGROUND: Prolonged mechanical ventilation for acute medical conditions increases the risk of chronic critical illness (CCI). Close family members are confronted with the life-threatening condition of the CCI patients and are prone to develop posttraumatic stress disorder affecting their health-related quality of life (HRQL). Main aim of the present study was to investigate patient- and family-related risk factors for posttraumatic stress and decreased HRQL in family members of CCI patients. METHODS: In a cross-sectional design nested within a prospective longitudinal cohort study, posttraumatic stress symptoms and quality of life were assessed in family members of CCI patients (n = 83, aged between 18 and 72 years) up to 6 months after transfer from ICU at acute care hospital to post-acute rehabilitation. Patients admitted a large rehabilitation hospital for ventilator weaning. The Posttraumatic Stress Scale-10 and the Euro-Quality of life-5D-3L were applied in both patients and their family members via telephone interview. RESULTS: A significant proportion of CCI patients and their family members (14.5 and 15.7 %, respectively) showed clinically relevant scores of posttraumatic stress. Both CCI patients and family members reported poorer HRQL than a normative sample. Factors independently associated with posttraumatic stress in family members were the time following ICU discharge (β = .256, 95 % confidence interval .053-.470) and the patients\' diagnosis of PTSD (β = .264, 95 % confidence interval .045-.453). Perceived satisfaction with the relationship turned out to be a protective factor for posttraumatic stress in family members of CCI patients (β = -.231, 95 % confidence interval -.423 to -.015). Regarding HRQL in family members, patients\' acute posttraumatic stress at ICU (β = -.290, 95 % confidence interval -.360 to -.088) and their own posttraumatic stress 3 to 6 months post-transfer (β = -.622, 95 % confidence interval -.640 to -.358) turned out to be significant predictors. CONCLUSIONS: Posttraumatic stress and HRQL should be routinely assessed in family members of CCI patients at regular intervals starting early at ICU. Preventive family-centered interventions are needed to improve posttraumatic stress and HRQL in both patients and their family members.

Background Fatigue often occurs as long-term complication in chronically critically ill (CCI) patients after prolonged intensive care treatment. The Multidimensional Fatigue Inventory (MFI-20) has been established as valid instrument to measure fatigue in a wide range of medical illnesses. Regarding the measurement of fatigue in CCI patients, the psychometric properties of the MFI-20 have not been investigated so far. Thus, the present study examines reliability and validity of the MFI-20 in CCI patients. Methods A convenience sample of n = 195 patients with Critical Illness Polyneuropathy (CIP) or Myopathy (CIM) were recruited via personal contact within four weeks (t1) following the transfer from acute care ICU to post-acute ICU at a large rehabilitation hospital. N = 113 (median age 61.1 yrs., 72.6% men) patients were again contacted via telephone three (t2) and six (t3) months following the transfer to post-acute ICU. The MFI-20, the Euro-Quality of Life (EQ-5D-3 L) and the Structured Clinical Interview for the Diagnostic and Statistical Manual of mental disorders DSM-IV (SCID-I) were applied within this prospective cohort study. Results The internal consistency Cronbach’s α was adequate for the MFI-total and all but the subscale Reduced Motivation (RM) (range: .50–.91). Item-to-total correlations (range: .22–.80) indicated item redundancy for the subscale RM. Confirmatory Factor analyses (CFAs) revealed poor model fit for the original 5-factor model of the MFI-20 (t2/t3, Confirmatory Fit Index, CFI = .783/ .834; Tucker-Lewis Index, TLI = .751/ .809; Root Mean Square Error of Approximation, RMSEA = .112/ .103). Among the alternative models (1-, 2-, 3-factor models), the data best fit to a 3-factor solution summarizing the highly correlated factors General −/ Physical Fatigue/ Reduced Activity (GF/ PF/ RA) (t2/ t3, CFI = .878/ .896, TLI = .846/ .869, RMSEA = .089/ .085, 90% Confidence Interval .073–.104/ .066–.104). The MFI-total score significantly correlated with the health-related quality of life (range: −.65-(−).66) and the diagnosis of major depression (range: .27–.37). Conclusions In the present sample of CCI patients, a reliable and valid factor structure of the MFI-20 could not be ascertained. Especially the subscale RM should be revised. Since the factors GF, PF and RA cannot be separated from each other and the unclear factorial structure in the present sample of CCI patients, the MFI-20 is not recommended for use in this context.

No description available.

Due to the successful rollout of the Antiretroviral Therapy Program, an increasing number of perinatally HIV infected adolescents are emerging into young adulthood throughout Botswana. Young adulthood is a critical period of human development, with long-lasting implications for a person’s economic security, health and well-being. During this time, young women and men normally complete school, find employment and start working, develop relationships, form families, bear children and pursue those things that help set them on the path to healthy and productive adult life. However, the presence of a chronic illness such as HIV can interfere with the achievement of the developmental milestones of young adulthood and affect their Health Related Quality of Life (HRQOL). The purpose of this study was to identify the factors that affected the HRQOL of young adults living with perinatally acquired HIV (YALPH) and to propose policy guidelines to promote their HRQOL. A mixed-methods sequential explanatory research design was used. HRQOL assessments were made using the WHOQOL-HIV BREF instrument. Data about the clinical characteristics of the respondents was obtained from medical records. In-depth interviews were conducted with a purposefully selected subsample of respondents who completed the WHOQOL-HIV BREF instrument. All the respondents were recruited from Botswana-Baylor Children’s Clinical Centre of Excellence, in Gaborone, Botswana. Data were analyzed using SPSS Inc. software version 16.0 (statistical package for social science, SPSS Inc, Chicago, IL, USA). The study population consisted of 509 YALPH including 255 (50.1%) females and 254 (49.9%) males. The mean age of the population was 21.7 (± 2.6) years (range 18-29.8 years). The majority of the respondents were single (98.1%), living in their parental homes (90.8%), neither in school nor working (47.35%) and 14% were parents (range 1-3 children). The mean duration on ART was 12.4 years (± 4.0). Based on the BMI classifications by WHO, 38.5% of respondents were underweight (BMI < 18.5 kg/m2) and 7.3% were overweight (BMI ≥ 25.0 kg/m2). Unsuppressed viral load (>400 cell/mL) occurred in 13.4% of the sample. Most respondents had good HROQL (78.4%). The highest mean HRQOL score was recorded in the Physical domain (15.4 (± 2.9) and the lowest in the Environment domain 13.8 (± 2.7). The results fitted using the multivariable logistic regression suggest the odds for good general QOL were increased amongst individuals with a higher level of education and 6 those who were employed. The odds for good general QOL were reduced for individuals with unsuppressed viral load (> 400 cells/mm2) and those who had illnesses (self-reported). The odds for good general QOL increased by almost two folds (OR = 1.97, 95% CI = (1.11 – 3.48)) when comparing respondents with higher level of education against those with lower education. The odds for good general QOL were increased for employed respondents OR = 1.73 (95% CI = (0.92 – 3.23) when compared to the unemployed group. Whereas the odds for good general QOL declined by almost two folds (OR = 0.60, 95% CI = (0.33 – 1.08)) amongst patients with VL > 400 cell/mm2 compared to those with VL < 400 cells/mm2. Also, respondents who were ill had lower odds ratios for good general QOL compared to those who were not ill (OR = 0.42, 95% CI = (0.25 – 0.70)). The results of in-depth interviews with 45 respondents showed that the majority of YALPH were in good physical health and they had positive perspectives about the future including health, completing school, finding employment, marriage and childbearing. The main sources of social support for YALPH were close family members and health care workers (HCWs). However, worries and concerns about disclosure, fear of stigma, lack of financial independence, and limited social relationships and networks were the most identified stressors that put the YALPH at risk of compromised HRQOL. Some sub-groups of YALPH were at higher risk for poor HRQOL including: young mothers, YALPH who were aging out of institutional care, YALPH with disabilities and impairments, YALPH who were neither in school nor working and YALPH with maladaptive coping strategies. Therefore, the promotion of the HRQOL of YALPH will require policies and interventions to increase educational attainment, provide employment and livelihood opportunities, promote good ART adherence and VL suppression, and effectively prevent and manage illnesses. Special attention should be paid to sub-groups of YALPH who are at increased risk of compromised HRQOL. / Health Studies / D. Litt. et Phil. (Health Studies)

No description available.

No description available.

Dans un système de santé avec budget limité, l’efficience des différentes options thérapeutiques doit être comparée afin d’assurer une allocation optimale des ressources. À cette fin, l’analyse coût-utilité (ACU) est privilégiée par les agences d’évaluation des technologies de la santé et requiert des données pharmacoéconomiques telles que les coûts et les scores d’utilité. Toutefois, les données pharmacoéconomiques ne sont pas systématiquement collectées lors des essais contrôlés randomisés (ECR). Lorsqu’elles le sont, elles sont soumises aux limites des ECR affectant ainsi la validité externe des résultats. Cela a mené à l’émergence des études en pratique réelle (real-world evidence studies) comme évidence complémentaire aux ECR aux fins de remboursement. Les données en pratique réelle peuvent être des données primaires (recueillies spécifiquement pour répondre à un objectif particulier) ou des données secondaires (données déjà collectées pour répondre à d’autres objectifs). D’importantes données pharmacoéconomiques, telles que l’utilité, la perte de productivité et les coûts non médicaux, étant généralement manquantes dans les banques de données traditionnelles, les chercheurs en pharmacoéconomie doivent parfois générer leurs propres données. Néanmoins, il n’existe pas de lignes directrices spécifiques pour guider les chercheurs désirant générer des données pharmacoéconomiques en pratique réelle. Le but de cette thèse était d’étudier et contribuer à l’amélioration des pratiques méthodologiques pour la génération de données pharmacoéconomiques en pratique réelle. Précisément, l’objectif du volet 1 était donc de caractériser les pratiques méthodologiques des études collectant des données de pharmacoéconomie et d’évaluer la qualité des résultats obtenus. Une revue systématique de la littérature a permis de confirmer certaines craintes face aux études de pratique réelle, c’est-à-dire le manque de transparence et de crédibilité. Le volet 1 a mis de l’avant le besoin d’améliorer les méthodologies actuelles qui ne produisent pas toujours des résultats robustes, pouvant ainsi affecter la validité et la pertinence des évaluations économiques. Un cadre de recherche spécifique à la collecte de données pharmacoéconomiques en pratique réelle pourrait augmenter la qualité des résultats générés. L’objectif du volet 2 était donc d’identifier les lignes directrices spécifiques à la génération de données d’utilité. Ensuite, d’incorporer les bonnes pratiques méthodologiques dans une boîte à outils destinée spécifiquement aux investigateurs cherchant à générer des valeurs d’utilité en pratique réelle. Bien que cette thèse englobe plus largement l’ensemble des données pharmacoéconomiques, telles que les coûts et l’utilité, la boîte à outils se concentre sur les scores d’utilité uniquement. Il s’agit d’un premier pas vers des lignes directrices officielles fournissant des bonnes pratiques méthodologiques pour la conception et conduite d’études en pharmacoéconomie. Pour ce qui est du volet 3, l’objectif était de mettre en pratique la boîte à outils en rédigeant un protocole de recherche de qualité, pertinent et applicable à la réalité des chercheurs en pratique réelle. Précisément, d’utiliser les recommandations de la boîte à outils afin de mettre en place un devis d’étude et des procédures d’étude qui limitent le risque de biais. Cette thèse contribue à l’avancement des bonnes pratiques et sensibilise la communauté de chercheurs à viser un niveau hiérarchique d’évidence plus élevé. La standardisation des méthodologies pour générer des données pharmacoéconomiques en pratique réelle est un besoin qui demeure non comblé. / In a resource-constrained healthcare system, the effectiveness of various therapeutic interventions must be compared by the means of economic evaluations to ensure optimal resource allocation. The cost-utility analysis (CUA) is favored by health technology assessment (HTA) agencies, and requires health economics and outcomes research (HEOR) data such as costs and utilities. Although they have gained prominence, HEOR data are not systematically collected in randomized controlled trials (RCTs). Even if they were, RCTs are well-known to have inherent limitations leading to a low external validity. Consequently, real-world evidence (RWE) studies have been used as complementary evidence in reimbursement decision-making. Real-world data can be primary data (specifically collected to achieve a certain objective) or secondary data (data that have already been collected for other purposes). However, important HEOR data, such as utility scores, productivity and non-medical costs, are not routinely collected in traditional databases. Therefore, HEOR investigators may need to generate their own pharmacoeconomic data. Nevertheless, there is no single guideline for investigators seeking guidance on methodological steps to estimate HEOR data in a real-world setting. The goal of this thesis was to study and improve good practices for HEOR data generation in a real-world setting. Specifically, the objective of the first article was to characterize methodological practices for collecting HEOR data as well as critically appraise the quality of the results. The systematic literature review confirmed concerns about RWE studies, namely the lack of transparency and credibility. The first article highlighted the need for good practices as current methodologies may not generate robust estimates, thereby affecting the validity and relevance of economic evaluations. A research framework specifically designed for HEOR data collection in a real-world setting could help improve the quality of results. Thus, the objective of the second article was to review current recommendations for health state utility (HSU) generation, and incorporate methodological standards into a single toolbox intended for investigators seeking to collect HSU in a real-world setting. Although this thesis broadly encompasses HEOR data, such as costs and utilities, the toolbox focuses on utility scores only. This is a first step toward official guidelines providing good practice recommendations for designing and conducting HEOR studies. As for the third article, the objective was to use the toolbox to develop a study protocol that is relevant, realistic and of good methodological quality. The recommendations of the toolbox were followed to design the study and limit bias. This thesis provides good practices to help generate high quality HEOR estimates, and motivate investigators to improve the level of evidence to be generated. Standardization of RWE studies collecting HSU has yet to come.

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In Anbetracht steigender Inzidenzraten für Tumorerkrankungen, bei gleichzeitig steigenden Überlebensraten, gewinnt die Frage nach der verbleibenden gesundheitsbezogenen Lebensqualität (HRQOL) im klinischen Alltag immer größere Bedeutung. Für einige HRQOL- Domänen bzw. Symptom-Items konnte bereits gezeigt werden, dass diese mit der Überlebenszeit von Patienten korrelieren bzw. Prädiktoren für längeres Überleben sind. Ziel der vorliegenden Studie war es die gesundheitsbezogenen Lebensqualität (HRQOL) bei einer großen Kohorte (N=1879) deutscher Tumorpatienten zu untersuchen. Mit Hilfe des Fragebogens EORTC QLQ-C30 (Version 3.0) wurde die physische Funktion, Rollenfunktion, emotionale Funktion, kognitive Funktion, soziale Funktion, Fatigue und die globale Lebensqualität gemessen. Aus der Krankenakte der betreffenden Patienten wurden relevante soziodemographische Merkmale (Alter, Geschlecht, Nationalität, Body-Mass-Index) und klinische Merkmale (Diagnose, TNM- Stadium, Therapieform, Intervall seit Diagnose, Rehabilitationsmaßnahme) extrahiert und statistisch ausgewertet. Wir stellten fest, dass die Tumorpatienten in allen HRQOL-Domänen starke Beeinträchtigungen im Vergleich zur gesunden deutschen Allgemeinbevölkerung zeigen. In besonderem Maße zeigten sich jüngere Tumorpatienten (≤59Jahre) beeinträchtigt. Weiterhin sahen wir klinisch relevante Beeinträchtigungen bei Patienten mit einer Therapiekombination aus Radio- und Chemotherapie, Patientinnen mit Brustkrebs und Tumoren des weiblichen Genitaltrakts und Patienten mit Migrationshintergrund aus Südosteuropa. Im gesamten Patientenkollektiv stellten wir eine überdurchschnittlich hohe Ausprägung von Fatigue (CRF) fest. Aufgrund der gemessenen Beeinträchtigungen der HRQOL, sowie der hohen Ausprägung von CRF sollten den betroffenen Patienten möglichst frühzeitig zusätzliche spezifische Therapie-Angebote unterbreitet werden, wie z.B. eine onkologische Rehabilitation und psycho-onkologische Therapiemaßnahmen, denn diese Intervention zeigte eine klinisch relevante Verbesserung in allen HRQOL-Domänen. Die routinemäßige Erfassung der subjektiven Lebensqualität der Betroffenen stellt in unseren Augen eine wichtige Zielgröße dar, welcher in der Routineversorgung neben objektiven Befunden (wie Tumoransprechen usw.) viel mehr Beachtung geschenkt werden sollte.