Max Geraedts

Assessing health-related quality of life in patients with restless legs syndrome

BACKGROUND Restless Legs Syndrome (RLS) has a substantial impact on normal daily activities. Because of the high prevalence it is necessary to evaluate the impact on the health-related quality of life (HRQoL). OBJECTIVE To assess health-related quality of life in patients with RLS. METHODS A total of 519 patients (327 female patients; mean age: 64.2 y) were recruited in five different German centers according to the diagnostic criteria of the International RLS Study Group. Patients were either interviewed or completed a mailed questionnaire. The questionnaire consisted of an evaluation of the sociodemographic, clinical and health-related status. HRQoL was evaluated with the EuroQoL (EQ-5D). In addition, the IRLS scale, the MOS Sleep Scale, the Epworth Sleepiness Scale, and the BDI were applied as clinical rating scales. RESULTS HRQoL is substantially affected by RLS. The mean EQ-5D-VAS was 55.6 and considerably lower compared to the general population. It was found to be as low as in other chronic neurological disorders such as Parkinsons disease and stroke. From different factors investigated by uni- and multivariate analyses, severity of RLS and depressive symptoms had the most significant impact on HRQoL. Additionally, sleep deficits, the duration of the disease and net household income were identified as predictors for different EQ-5D outcome scores. CONCLUSIONS RLS considerably affects HRQoL. Further comparative studies are necessary to evaluate the effect of disease symptoms on HRQoL and their change due to medication.

Evaluation of quality of life and description of the sociodemographic state in adolescent and young adult patients with phenylketonuria (PKU)

BackgroundNormal intellectual and personal development can be expected in early-diagnosed and treated PKU patients. Aim of the study was to analyse quality of life and social status, which are important parameters for an overall estimation of success of treatment apart from intellectual outcome in adult PKU patients.Methods67 patients completed a questionnaire on quality of life and social status. Data was compared to the German census on an age matched control collective.ResultsQuality of life measured with the Profile of Quality of Life in the Chronically Ill (PLC) revealed mean values for capacity of performance in the patient group in the same range as in the control collective.The analysis of the social state of PKU patients revealed a tendency towards lower or delayed autonomy, and a low rate of forming normal adult relationships in which to have children. Schooling and professional career corresponded approximately to the control collective.ConclusionThough every chronic disorder must be regarded as restraining, it shows that PKU does not preclude healthy emotional adjustment when the disease is diagnosed early and treated well.

Stufe-3-Leitlinie Brustkrebs-Früherkennung in Deutschland 2008

ZusammenfassungDie aktualisierte Stufe-3-Leitlinie Brustkrebs-Früherkennung in Deutschland 2008 vermittelt den wissenschaftlichen Kenntnisstand in evidenz- und konsensbasierter Form und ist unter Beteiligung der Deutschen Gesellschaft für Chirurgie e.V, der Deutschen Gesellschaft der Plastischen, Rekonstruktiven und Ästhetischen Chirurgen e.V. und 29 weiterer Fachgesellschaften, Berufsverbänden und nichtärztlichen Organisationen erstellt. Ziel der Stufe-3-Leitlinie ist es, Ärzte sowie gesunde und betroffene Frauen durch evidenzbasierte und formal konsentierte Empfehlungen bei anstehenden medizinischen Entscheidungen im Rahmen der Diagnosekette zur Früherkennung von Brustkrebs zu unterstützen. Die Leitlinie umfasst neben den Empfehlungen zur Diagnosekette die Beschreibung zur Ausgestaltung der Qualitätssicherung von Struktur-, Prozess- und Ergebnisqualität (Outcomes) sowie deren Evaluation durch einen Qualitätsindikatorensatz.Die aktualisierte Stufe-3-Leitlinie 2008 löst die 2003 erstellte Leitlinie ab.Die Leitlinienempfehlungen werden dargestellt. Die Details sind der Publikation in Geburtsh Frauenh 2008; 68: 251–26 zu entnehmen. Die Langfassung der Leitlinie ist als Buch im W. Zuckschwerdt Verlag GmbH/München erschienen und ist, wie der Methodenreport und der Evidenzreport auch, über die Internetseite www.awmf-leitlinien.de (Reg.: Nr. 077/001) frei zugänglich.AbstractThe updated 2008 German Guideline for Early Detection of Breast Cancer provides evidence-based and consensus-based recommendations of the knowledge gained by the German Society for Surgery and the German Society of Plastic, Aesthetic, and Reconstructive Surgeons together with 29 professional societies, associations, and nonmedical organizations. The guideline is meant to assist physicians, healthy women, and patients in medical decisions with recommendations regarding the diagnostic chain in early detection of breast cancer. In addition to these recommendations, the guideline also includes descriptions of quality assurance for resources, procedures, outcomes, and evaluation using a set of quality indicators. It updates the previous version from 2003. The guideline’s recommendations are presented. They are described in detail in the full publication (in German) Geburtsh Frauenh 2008; 68:251–261. The long version of the Guideline, methods report, and evidence report are available on the internet at www.awmf-leitlinien.de (reg. no. 077/001) with free access.The updated 2008 German Guideline for Early Detection of Breast Cancer provides evidence-based and consensus-based recommendations of the knowledge gained by the German Society for Surgery and the German Society of Plastic, Aesthetic, and Reconstructive Surgeons together with 29 professional societies, associations, and nonmedical organizations. The guideline is meant to assist physicians, healthy women, and patients in medical decisions with recommendations regarding the diagnostic chain in early detection of breast cancer. In addition to these recommendations, the guideline also includes descriptions of quality assurance for resources, procedures, outcomes, and evaluation using a set of quality indicators. It updates the previous version from 2003. The guidelines recommendations are presented. They are described in detail in the full publication (in German) Geburtsh Frauenh 2008; 68:251-261. The long version of the Guideline, methods report, and evidence report are available on the internet at www.awmf-leitlinien.de (reg. no. 077/001) with free access.

Germany’s Long-Term-Care Insurance: Putting a Social Insurance Model into Practice

A growing population of elderly has intensified the demand for long-term care (LTC) services. In response to the mounting need, Germany put into effect a LTC Insurance Act in 1995 that introduced mandatory public or private LTC insurance for the entire population of 82 million. The program was based on the organizational principles that define the German social insurance system. Those individuals in the public system and their employers each pay contributions equal to 0.85 percent of each employees gross wages or salary. Ten percent of the population with the highest incomes have chosen the option of purchasing private long term care insurance. Provisions were made for uniform eligibility criteria, benefits based on level of care needs, cost containment, and quality assurance. Over the first four years of its operation, the system has proved financially sound and has expanded access to organized LTC services. The German system thus may serve as an example for other countries that are planning to initiate social LTC insurance systems in other nations.

Two Short-Term Outcomes After Instituting a National Regulation Regarding Minimum Procedural Volumes for Total Knee Replacement

BACKGROUND Several studies have demonstrated positive relationships between high hospital volume and improved outcome following total knee replacement. To our knowledge, it has not been demonstrated whether improved outcomes are causally determined by selective referral to high-volume hospitals. We therefore evaluated the effect of a national regulation regarding minimum hospital volume for total knee replacement on two short-term outcome parameters. METHODS We performed a comparison of the years before (2004, 2005) and after (2006) the implementation of a national regulation on minimum hospital volume for total knee replacement through a secondary analysis of a national database on the quality of inpatient care in Germany as reflected by the number of cases per hospital and the postoperative rates of wound infection and wound hematoma or secondary hemorrhage. RESULTS We analyzed 110,349 cases from 2004, 118,922 cases from 2005, and 125,322 cases from 2006. Implementation of the regulation had a significant effect on the number of cases per hospital. Of the hospitals that had performed one to forty-nine cases in 2005, 35.6% moved to higher-volume categories and 21.2% dropped out in 2006. Multiple logistic regression analysis adjusting for patient characteristics demonstrated risk reductions of 22.5% (odds ratio, 0.775; 95% confidence interval, 0.700 to 0.857) for postoperative wound infection and of 44% (odds ratio, 0.562; 95% confidence interval, 0.531 to 0.596) for wound hematoma or secondary hemorrhage from 2005 to 2006. For wound infection, approximately half of the improvement was attributable to the effects of the minimum-volume regulation. For wound hematoma and secondary hemorrhage, the improvement could not be explained by the minimum-volume regulation. CONCLUSIONS Implementation of the minimum-volume regulation for total knee replacement resulted in more patients being managed at higher-volume hospitals than expected. Following the implementation of a minimum-volume regulation, effects on two short-term outcome parameters were observed, but definite conclusions could only be made regarding wound infection, with the minimum-volume regulation resulting in a decreased rate of infection.

2008 update of the guideline: early detection of breast cancer in Germany

IntroductionThe goal of the 2008 updated guideline: early detection of breast cancer in Germany is to support physicians as well as healthy and affected women in the decision-making process involved in the diagnostic chain for the early detection of breast cancer by providing them with evidence- and consensus-based recommendations. The updated guideline replaces the guideline issued in 2003.Materials and methodsThe guideline forms the basis for developing an effective and efficient national early breast cancer detection program that meets the standards set by the Council of Europe and WHO for cancer control programs. The guideline presents the current, evidence- and consensus-based state of scientific knowledge in a multidisciplinary approach for the entire diagnostic chain, consisting of history taking and risk consultation, information on health behavior, clinical breast examination, diagnostic imaging, image-guided percutaneous tissue-acquisition techniques, open surgical excisional biopsy and pathomorphological tissue evaluation. The guideline recommends a set of quality indicators to assure resource availability, performance quality and outcomes enhancing total quality management for early breast cancer diagnosis.Conclusion Currently, early detection of breast cancer offers the most promising possibility to optimize the diagnosis and treatment of breast cancer and, as a result, reduce breast cancer mortality and improve health related quality of life in women.

Health Economic Burden of Patients with Restless Legs Syndrome in a German Ambulatory Setting

AbstractBackground: The primary characteristics of restless legs syndrome (RLS), including severe sleep disorders, restlessness in the evening and discomfort while at rest, have substantial impact on normal daily activities. Because of the high prevalence of RLS in the general population, it is necessary to evaluate the economic impact of RLS. Objective: To determine the health economic burden of patients with RLS in Germany. Methods: A total of 519 RLS patients (mean age: 65.2–11.1 years) in different stages of disease were recruited in five health centres (university hospitals, district hospitals and office-based neurologists) by applying the diagnostic criteria of the International Restless Legs Syndrome Study Group. A questionnaire was administered that assessed healthcare resource consumption as well as socioeconomic, demographic, clinical and health status.In addition, the International RLS severity scale (IRLS), Epworth Sleepiness Scale (ESS), EQ-5D and Beck Depression Inventory (BDI) were addressed in the assessment. Direct and indirect costs (€, year 2006 values) were derived from various German economic resources and calculated from the perspective of the healthcare and transfer payment providers. Results: We calculated average total costs over the 3-month observation period. It was determined that average total costs were €2090 for this period. The average direct medical and non-medical costs from the perspective of the health insurance provider were determined to be €780, with €300 attributed to drug costs and €354 to hospitalization costs. Average total indirect costs amounted to h1308 and were calculated based on productivity loss, using the human capital approach. As cost-driving factors we identified disease severity according to the IRLS (p < 0.01) and ESS (p < 0.04). Health-related quality of life was determined to be substantially affected by RLS; the mean EQ-5D visual analogue scale (VAS) was 55.6, considerably lower than that of the agematched general population. Conclusion: RLS places a notable financial burden on society as well as on patients and their families. More detailed studies are needed to evaluate the health economic impact of this disorder.

Placebo effect sizes in homeopathic compared to conventional drugs - a systematic review of randomised controlled trials

BACKGROUND It has been hypothesised that randomised, placebo-controlled clinical trials (RCTs) of classical (individualised) homeopathy often fail because placebo effects are substantially higher than in conventional medicine. OBJECTIVES To compare placebo effects in clinical trials on homeopathy to placebo effects on trials of conventional medicines. METHODS We performed a systematic literature analysis on placebo-controlled double-blind RCTs on classical homeopathy. Each trial was matched to three placebo-controlled double-blind RCTs from conventional medicine (mainly pharmacological interventions) involving the same diagnosis. Matching criteria included severity of complaints, choice of outcome parameter, and treatment duration. Outcome was measured as the percentage change of symptom scores from baseline to end of treatment in the placebo group. 35 RCTs on classical homeopathy were identified. 10 were excluded because no relevant data could be extracted, or less than three matching conventional trials could be located. RESULTS In 13 matched sets the placebo effect in the homeopathic trials was larger than the average placebo effect of the conventional trials, in 12 matched sets it was lower (P=0.39). Additionally, no subgroup analysis yielded any significant difference. CONCLUSIONS Placebo effects in RCTs on classical homeopathy did not appear to be larger than placebo effects in conventional medicine.

Evaluating compulsory minimum volume standards in Germany: how many hospitals were compliant in 2004?

BackgroundMinimum hospital procedure volumes are discussed as an instrument for quality assurance. In 2004 Germany introduced such annual minimum volumes nationwide on five surgical procedures: kidney, liver, stem cell transplantation, complex oesophageal, and pancreatic interventions. The present investigation is the first part of a study evaluating the effects of these minimum volumes on health care provision. Research questions address how many hospitals and cases were affected by minimum volume regulations in 2004, how affected hospitals were distributed according to minimum volumes, and how many hospitals within the 16 German states complied with the standards set for 2004.MethodsThe evaluation is based on the mandatory hospital quality reports for 2004. In the reports, all hospitals are statutorily obliged to state the number of procedures performed for each minimum volume. The data were analyzed descriptively.ResultsIn 2004, 485 out of 1710 German hospitals providing acute care and approximately 0.14% of all hospital cases were affected by minimum volume regulations. Liver, kidney, and stem cell transplantation affected from 23 to hospitals; complex oesophageal and pancreatic interventions affected from 297 to 455 hospitals. The inter-state comparison of the average hospital care area demonstrates large differences between city states and large area states and the eastern and western German states ranging from a minimum 51 km2 up to a maximum 23.200 km2, varying according to each procedure. A range of 9% – 16% of the transplantation hospitals did not comply with the standards affecting 1% – 2% of the patients whereas 29% and 18% of the hospitals treating complex oesophageal and pancreatic interventions failed the standards affecting 2% – 5% of the prevailing cases.ConclusionIn 2004, the newly introduced minimum volume regulations affected only up to a quarter of German acute care hospitals and few cases. However, excluding the hospitals not meeting the minimum volume standards from providing the respective procedures deserves considering two aspects: the hospital health care provision concepts by the German states as being responsible and from a patient perspective the geographically equal access to hospital care.

Germany's Long Term Care Insurance Model: Lessons for the United States

The implementation of public long term care (LTC) insurance in 1995 in Germany is an important public policy development that offers lessons for the U.S. The German LTC model is comprehensive and mandatory, covering 88 percent of its population, by equal premium contributions on wages from employees and employers. The new German system has uniform eligibility and benefit criteria, covers both institutional and home care, pays for family caregivers, is financially solvent, and is considered a success by the public. In contrast, the U.S. financing of LTC is largely private, with the government serving as the safety net for the majority of the LTC costs after individuals spend down their resources. This paper considers whether a German-type LTC system is feasible and affordable and discusses the issues and complexities of public LTC insurance, including cost containment, home care services, quality control, and administrative structure.