Wirtschaftlichkeit und Management in der Rehabilitation von Patienten mit chronischen Rückenschmerzen

Hintergrund: Die Trends stark steigender Ausgaben, innovativer medizinischer Verfahren und der Alterung der Gesellschaft machen eine stärkere Effizienzorientierung auch in der Rehabilitation unumgänglich. Die ökonomische Evaluation bietet einen Ansatz, diese Neuorientierung auf eine Evidenzbasis zu stellen. Ziel: In einem weit greifenden Ansatz sollte eine Intensivierung der stationären Rehabilitation von Patienten mit chronischen Rückenschmerzen auf ihre Wirksamkeit und Wirtschaftlichkeit untersucht und Ansatzpunkte einer Einbindung der Erkenntnisse in die Versorgung gesucht werden. Methoden: Die ökonomische Evaluation begleitete einen klinischen Versuch, in dem ein intensiviertes psychologisches Programm mit der herkömmlichen stationären Rehabilitation mit einer Nachverfolgung von einem halben Jahr verglichen wurde. Zuvor waren in Pilotstudien Instrumente zur Messung der poststationären Kosten mittels eines Kostenwochenbuchs und der Effekte – in Form gesundheitsbezogener Lebensqualität – mittels des Fragebogens des EuroQol 5D getestet worden. Die Einbindung von Studienergebnissen wurde durch konzeptionelle Analysen zur Entscheidungsfindung und zum Rehabilitationsmanagement untersucht. Ergebnisse: In jedem Studienarm nahmen etwa 200 Patienten teil. Die intensivierte psychologische Betreuung führte zu einer leichten Verbesserung der gesundheitsbezogenen Lebensqualität – gemessen auch in qualitätsbereinigten Lebensjahren (QALYs), die aber nicht statistisch signifikant war. Den leicht erhöhten Versorgungskosten standen deutliche Einsparungen durch eine Verbesserung der Erwerbsfähigkeit in der Nachbeobachtungszeit gegenüber. Auf Grund einer hohen Streuung der Resultate war die Verbesserung der Wirtschaftlichkeit aber statistisch nicht signifikant, was eine Empfehlung an Entscheidungsträger erschwert. Durch das Setzen von Anreizen, die an der Erwerbsfähigkeit und dem langfristigen Gesundheitszustand der behandelten Patientengruppen anknüpfen, könnte das Rehabilitationsmanagement stärker ökonomisch ausgerichtet werden. Diskussion: Die Untersuchung der Wirtschaftlichkeit von Rehabilitationsmaßnahmen kann in einem aufwändigen Verfahren begleitend zu einem klinischen Versuch durchgeführt werden. In der vorliegenden Studie gehörten die Prüfung der eingesetzten Instrumente, der Umgang mit fehlenden Werten an den verschiedenen Messzeitpunkten und die Interpretation der hohen Unsicherheit der Effekte und der Kosten-Effektivitätsrelation sowie zu den methodischen Herausforderungen. Schlussfolgerung: Bezogen auf die Kosten des Produktivitätsausfalls weist die Intensivierung der Rehabilitation in eine Erfolg versprechende Richtung. Hinsichtlich der Lebensqualitätseffekte ist weiter nach wirksameren Rehabilitationsmaßnahmen zu suchen. Grundsätzlich könnten Anreize zu beiden Teilendpunkte ein effizientes Rehabilitationsmanagement fördern

Kosten und Lebensqualität bei ambulanter vs. stationärer kardiologischer Rehabilitation – ein gesundheitsökonomischer Ansatz

Hintergrund: Die ischämischen Herzerkrankungen wie der Myokardinfarkt gewinnen in Deutschland, unter anderem auf Grund des demographischen Wandels, zunehmend auch ökonomisch an Bedeutung. Die sich an die Phase der Akutversorgung anschließende kardiologische Rehabilitation wurde bisher in Deutschland überwiegend stationär durchgeführt. Ziel: Das Ziel der SARAH-Studie war es, basierend auf einem klinischen Versuch, die Kosten für die unterschiedlichen Rehabilitationsmaßnahmen sowie die erzielten Effekte hinsichtlich der Lebensqualität zu ermitteln und die Ergebnisse von ambulanter und stationärer Rehabilitation miteinander zu vergleichen. Methoden: Es wurde eine kontrollierte Beobachtungsstudie mit 163 Patienten durchgeführt, die einem comprehensive cohort design folgte. Die Beobachtung erstreckte sich über einen Zeitraum von 12 Monaten nach der Rehabilitation. Die Kosten wurden anhand der Kostenrechnung der Rehazentren und anhand der Patientenangaben zu einer retrospektiven Kostenbefragung ermittelt. Die gesundheitsbezogene Lebensqualität wurde mit dem EuroQol (EQ-5D) gemessen und bewertet. Ergebnisse: Über den gesamten Beobachtungszeitraum konnten die Daten von 140 Patienten ausgewertet werden, d.h. es wurde eine Rücklaufquote von 86% erreicht. Die Studie ergab einen deutlichen Lebensqualitätsgewinn, sowohl bei der stationären, als auch bei der ambulanten Rehabilitationsmaßnahme; diese Verbesserung der Lebensqualität bleibt bei beiden Settings größtenteils über den gesamten Nachbeobachtungszeitraum erhalten. Zwischen den Settings gab es allerdings keinen statistisch signifikanten Unterschied. Bei den direkten Kosten war das ambulante Setting auf Grund der niedrigeren tagesgleichen Kosten um 760€ günstiger als die stationäre Rehabilitation. Diskussion: Einschränkungen der Studie ergeben sich durch die geringe Bereitschaft der Patienten, sich wie vorgesehen randomisieren zu lassen, was eine entsprechende Analyse verhinderte und zu einer geringen Besetzung des ambulanten Arms führte; ferner konnten nur Kosten jeweils einer Angebotseinheit untersucht werden. Stärken sind im Einsatz vorab getesteter Messinstrumente, im hohen Rücklauf und in der Plausibilität der Angaben zu finden. Schlussfolgerung: Auch nach Betrachtung der indirekten Kosten und der statistischen Anpassung der Daten kann ein Kostenvorteil einer ambulanten Rehabilitationsmaßnahme gegenüber einer stationären Maßnahme nicht ausgeschlossen werden

Valuing health-related quality of life: systematic variation in health perception

Background: Population-based value sets are widely used to transform health states into utilities, but may deviate from actual patient experience. Whether this occurs in a systematic way can be analyzed, in a first step, for respondents who do not report problems on the five domains of the EQ-5D-5L instrument in population studies. Methods: EQ-5D-5L results from three annual cross-sectional surveys (2012, 2013, and 2014) were filtered for participants who reported being problem-free. Continuous visual analog scale (VAS) scores, ranging from 0 (worst imaginable health) to 100 (best imaginable health) were then used to measure their actual health perception and to compare results with the proposed EQ-5D-5L value. A multiple linear regression model was used to identify possible risk factors for low VAS scores. Results: Some 3739 (615%) participants reported being problem-free. Their mean age was 41.1 years and mean VAS score was 91.9. Age and BMI were significantly associated with lower VAS scores. Age groups from 50 years onwards reported VAS means of 90.0 and below. Female gender and low education also had small but significant negative effects on patient experience. The presence of BMI class III as well as diabetes had the greatest negative effect on VAS results (- 9.0 and - 8.4) and reached the range of minimally important differences. Heart disease (- 6.2) and musculoskeletal disease (- 3.4) also had strong negative effects. The 25th percentile of VAS scores in our sample was 90.0, and the 50th percentile was 95.0. Conclusions: For some groups in population studies, especially older people with high BMI and those affected by specific diseases, no problems on all five domains of the EQ-5D-5L fails to reflect the respondents' health perception as measured by the VAS

Comorbid Influences on Generic Health-Related Quality of Life in COPD: A Systematic Review

Background Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and of loss of disability-adjusted life years worldwide. It often is accompanied by the presence of comorbidity. Objectives To systematically review the influence of COPD comorbidity on generic health-related quality of life (HRQoL). Methods A systematic review approach was used to search the databases Pubmed, Embase and Cochrane Library for studies evaluating the influence of comorbidity on HRQoL in COPD. Identified studies were analyzed according to study characteristics, generic HRQoL measurement instrument, COPD severity and comorbid HRQoL impact. Studies using only nongeneric instruments were excluded. Results 25 studies met the selection criteria. Seven studies utilized the EQ-5D, six studies each used the SF-36 or SF-12. The remaining studies used one of six other instruments each. Utilities were calculated by four EQ-5D studies and one 15D study. Patient populations covered both early and advanced stages of COPD and ranged from populations with mostly stage 1 and 2 to studies with patients classified mainly stage 3 and 4. Evidence was mainly created for cardiovascular disease, depression and anxiety as well as diabetes but also for quantitative comorbid associations. Strong evidence is pointing towards the significant negative association of depression and anxiety on reduced HRQoL in COPD patients. While all studies found the occurrence of specific comorbidities to decrease HRQoL in COPD patients, the orders of magnitude diverged. Due to different patient populations, different measurement tools and different concomitant diseases the study heterogeneity was high. Conclusions Facilitating multimorbid intervention guidance, instead of applying a parsimony based single disease paradigm, should constitute an important goal for improving HRQoL of COPD patients in research and in clinical practice

Health-Related Quality of Life of the General German Population in 2015: Results from the EQ-5D-5L

The EQ-5D-5L is a widely used generic instrument to measure health-related quality of life. This study evaluates health perception in a representative sample of the general German population from 2015. To compare results over time, a component analysis technique was used that separates changes in the description and valuation of health states. The whole sample and also subgroups, stratified by sociodemographic parameters as well as disease affliction, were analyzed. In total, 2040 questionnaires (48.4% male, mean age 47.3 year) were included. The dimension with the lowest number of reported problems was self-care (93.0% without problems), and the dimension with the highest proportion of impairment was pain/discomfort (71.2% without problems). Some 64.3% of the study population were identified as problem-free. The visual analog scale (VAS) mean for all participants was 85.1. Low education was connected with significantly lower VAS scores, but the effect was small. Depression, heart disease, and diabetes had a strong significant negative effect on reported VAS means. Results were slightly better than those in a similar 2012 survey;the most important driver was the increase in the share of the study population that reported to be problem-free. In international comparisons, health perception of the general German population is relatively high and, compared with previous German studies, fairly stable over recent years. Elderly and sick people continue to report significant reductions in perceived health states

Quality of life assessment in interstitial lung diseases:a comparison of the disease-specific K-BILD with the generic EQ-5D-5L

Background: Patients with interstitial lung diseases (ILD) have impaired health-related quality of life (HRQL). Little is known about the applicability of the disease-specific King’s Brief Interstitial Lung Disease questionnaire (K-BILD) and the generic EQ-5D-5L in a German setting. Methods: We assessed disease-specific (K-BILD) and generic HRQL (EQ-5D experience based value set (EBVS) and Visual Analog Scale (VAS)) in 229 patients with different ILD subtypes in a longitudinal observational study (HILDA). Additionally, we assessed the correlation of the HRQL measures with lung function and comorbidities. In a linear regression model, we investigated predictors (including age, sex, ILD subtype, FVC percentage of predicted value (FVC%pred), DLCO percentage of predicted value, and comorbidities). Results: Among the 229 patients mean age was 63.2 (Standard deviation (SD): 12.9), 67.3% male, 24.0% had idiopathic pulmonary fibrosis, and 22.3% sarcoidosis. Means scores were as follows for EQ-5D EBVS 0.66(SD 0.17), VAS 61.4 (SD 19.1) and K-BILD Total 53.6 (SD 13.8). K-BILD had good construct validity (high correlation with EQ-5D EBVS (0.71)) and good internal consistency (Cronbach’s alpha 0.89). Moreover, all HRQL measures were highly accepted by patients including low missing items and there were no ceiling or floor effects. A higher FVC % pred was associated with higher HRQL in all measures meanwhile comorbidities had a negative influence on HRQL. Conclusions: K-BILD and EQ-5D had similar HRQL trends and were associated similarly to the same disease-related factors in Germany. Our data supports the use of K-BILD in clinical practice in Germany, since it captures disease specific effects of ILD. Additionally, the use of the EQ-5D-5L could provide comparison to different disease areas and give an overview about the position of ILD patients in comparison to general population

COMPANION: development of a patient-centred complexity and casemix classification for adult palliative care patients based on needs and resource use – a protocol for a cross-sectional multi-centre study

BACKGROUND: A casemix classification based on patients’ needs can serve to better describe the patient group in palliative care and thus help to develop adequate future care structures and enable national benchmarking and quality control. However, in Germany, there is no such an evidence-based system to differentiate the complexity of patients’ needs in palliative care. Therefore, the study aims to develop a patient-oriented, nationally applicable complexity and casemix classification for adult palliative care patients in Germany. METHODS: COMPANION is a mixed-methods study with data derived from three subprojects. Subproject 1: Prospective, cross-sectional multi-centre study collecting data on patients’ needs which reflect the complexity of the respective patient situation, as well as data on resources that are required to meet these needs in specialist palliative care units, palliative care advisory teams, and specialist palliative home care. Subproject 2: Qualitative study including the development of a literature-based preliminary list of characteristics, expert interviews, and a focus group to develop a taxonomy for specialist palliative care models. Subproject 3: Multi-centre costing study based on resource data from subproject 1 and data of study centres. Data and results from the three subprojects will inform each other and form the basis for the development of the casemix classification. Ultimately, the casemix classification will be developed by applying Classification and Regression Tree (CART) analyses using patient and complexity data from subproject 1 and patient-related cost data from subproject 3. DISCUSSION: This is the first multi-centre costing study that integrates the structure and process characteristics of different palliative care settings in Germany with individual patient care. The mixed methods design and variety of included data allow for the development of a casemix classification that reflect on the complexity of the research subject. The consecutive inclusion of all patients cared for in participating study centres within the time of data collection allows for a comprehensive description of palliative care patients and their needs. A limiting factor is that data will be collected at least partly during the COVID-19 pandemic and potential impact of the pandemic on health care and the research topic cannot be excluded. TRIAL REGISTRATION: German Register for Clinical Studies trial registration number: DRKS00020517

An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations?:Analysis and recommendations

Introduction: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that will hopefully increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to ad-hoc accelerated MD approval processes elsewhere (e.g., US). Areas covered: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in pre-market clinical evidence generation and lack of oversight for post-approval evidence requirements. Implications for MD approval, HTA and coverage are explored. Expert opinion: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed that can fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers’ evidence generation plans along the MD lifecycle (pre-, post-market), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.</p

Assessing quality of life in a clinical study on heart rehabilitation patients: how well do value sets based on given or experienced health states reflect patients' valuations?

Background: Quality of life as an endpoint in a clinical study may be sensitive to the value set used to derive a single score. Focusing on patients' actual valuations in a clinical study, we compare different value sets for the EQ-5D-3L and assess how well they reproduce patients' reported results. Methods: A clinical study comparing inpatient (n = 98) and outpatient (n = 47) rehabilitation of patients after an acute coronary event is re-analyzed. Value sets include: 1. Given health states and time-trade-off valuation (GHS-TTO) rendering economic utilities;2. Experienced health states and valuation by visual analog scale (EHS-VAS). Valuations are compared with patient-reported VAS rating. Accuracy is assessed by mean absolute error (MAE) and by Pearson's correlation.. External validity is tested by correlation with established MacNew global scores. Drivers of differences between value sets and VAS are analyzed using repeated measures regression. Results: EHS-VAS had smaller MAEs and higher. in all patients and in the inpatient group, and correlated best with MacNew global score. Quality-adjusted survival was more accurately reflected by EHS-VAS. Younger, better educated patients reported lower VAS at admission than the EHS-based value set. EHS-based estimates were mostly able to reproduce patient-reported valuation. Economic utility measurement is conceptually different, produced results less strongly related to patients' reports, and resulted in about 20 % longer quality-adjusted survival. Conclusion: Decision makers should take into account the impact of choosing value sets on effectiveness results. For transferring the results of heart rehabilitation patients from another country or from another valuation method, the EHS-based value set offers a promising estimation option for those decision makers who prioritize patient-reported valuation. Yet, EHS-based estimates may not fully reflect patient-reported VAS in all situations