Andrej Rasch

Cataract Surgery and the Development or Progression of Age-related Macular Degeneration: A Systematic Review

Age-related macular degeneration and cataract are the most frequent eye disorders of elderly people worldwide. The aim of this systematic review was to evaluate the effect of cataract surgery on the development and progression of age-related macular degeneration. Data were collected by means of a systematic literature search in 28 databases and an additional update in Pubmed. Search results were evaluated using pre-defined inclusion and exclusion criteria. All relevant publications were rated in terms of scientific quality and analyzed regarding their results. The literature search generated a total of 2,827 hits. Seven publications on five observational studies and two non-randomized clinical trials were eligible for analysis. The observational studies provided some evidence for an increased incidence of late age-related macular degeneration, respectively, for a promoting influence of cataract surgery on the progression of early types of age-related macular degeneration. The clinical trials did yield inconsistent results. In conclusion, only a small number of published studies investigated the development or progression of age-related macular degeneration following cataract surgery. The scientific level of evidence of these articles was not high and results were inconsistent, nevertheless a promoting influence of cataract surgery on the progression of early age-related macular degeneration can be assumed.

Long-term effectiveness of behavioural interventions to prevent smoking among children and youth

Objectives: To evaluate the long-term effectiveness of recent behavioural interventions in the prevention of cigarette use among children and youth and to compare the effectiveness of different school-based, community-based and multisectorial intervention strategies. Methods: A structured search of databases and a manual search of reference lists was conducted. Randomised controlled trials published in English or German between August 2001 and August 2006 targeting youths up to 18 years of age were assessed independently by two researchers according to predefined inclusion criteria and with regard to methodological quality. Data abstraction was performed and crosschecked by two researchers. Where appropriate, pooled effect estimates were calculated and tested in sensitivity analyses. Results: Of 3555 articles, 35 studies met the inclusion criteria. The follow-up duration ranged from 12 months to 120 months. Although the overall effectiveness of prevention programs showed considerable heterogeneity, the majority of studies reported some positive long-term effects for behavioural smoking prevention programs. There was evidence that community-based and multisectorial interventions were effective in reducing smoking rates; in contrast, the evidence for school-based programs alone was inconclusive. Regardless of the type of intervention, the reductions observed in smoking rates were only modest. Conclusions: The present work identified moderate evidence for the effectiveness of behavioural interventions to prevent smoking. Although evidence for the effectiveness of school-based interventions was inconclusive, evidence for the effectiveness of community-based and multisectorial interventions was somewhat stronger. Future research should investigate the effectiveness of specific intervention components and the cost-effectiveness of interventions analysed in methodologically high-quality studies.

Determinants of Willingness to Pay for a New Therapy in a Sample of Menopausal-Aged Women

AbstractBackground: Menopause is a natural physiological event that usually begins in women between the ages of 48 and 55 years. In many cases, this event is associated with unpleasant somatic-vegetative, urogenital or psychological symptoms. Objective: To test the health and social demographic factors (especially household income level) that influence willingness to pay (WTP) for a new hormone-free treatment in women of menopausal age. Methods: 1365 women between the ages of 45 and 73 years were surveyed about their health and WTP for the new treatment. WTP was evaluated with a closed-ended binary questionnaire (four groups with different levels of co-payment between €15 and €60), using the contingent valuation method. The average WTP was calculated according to the area under the demand function. Factors contributing to payment readiness were examined by means of binary logistic regression. Results: WTP was significantly affected by women’s opinion of the new medication, the level of co-payment required, net household income, whether currently in treatment for menopausal symptoms, and Menopause Rating Scale (MRS) values. Compared with other factors, the level of co-payment was predicted to have a negative impact on WTP. Income level is an important factor in WTP and correlates highly with several other health-related variables (WHO-5 index, MRS value, receipt of other menopause medicines and existing co-morbidity). The average co-payment that our group of women was willing to pay was between €17 and €35 per month, or €24 to €42 for women who were currently receiving treatment for symptoms of menopause. While interpreting the results, it should be considered that the hypothetical therapy was assumed to be a new non-reimbursable alternative to conventional therapy offered under the existing statutory framework for health insurance in Germany. Conclusions: Despite some methodological limitations, these results are useful for examining the factors affecting WTP and incremental utilities for future medicine dealing with menopause.

GRADE Leitlinien: 8. Einschätzung der Qualität der Evidenz – Indirektheit☆

Zusammenfassung Direkte Evidenz ergibt sich aus Analysen, die Interventionen von Interesse in relevanten Populationen direkt miteinander vergleichen und hierbei patientenrelevante Zielkriterien messen. Aus vier Grunden kann die Evidenz aber als indirekt bezeichnet werden. Erstens, die Patienten in den Studien konnen von der relevanten Population abweichen (der Begriff Ubertragbarkeit wird oft fur diese Form der Indirektheit verwendet). Zweitens, die untersuchte Intervention (und/oder der Komparator) konnen von den relevanten Interventionen abweichen. Dabei hangen die Entscheidungen hinsichtlich der Indirektheit von Patienten und Intervention vom Verstandnis ab, ob biologische oder soziale Faktoren so wesentlich abweichen, dass substanzielle Differenzen in der Effektgrose zu erwarten sind. Drittens, die Zielkriterien konnen von den primar relevanten Endpunkten abweichen, wenn z.B. Surrogatendpunkte (die selbst nicht relevant sind) mit der Annahme erhoben werden, dass die Veranderung der Surrogate die patientenrelevanten Endpunkte widerspiegelt. Der vierte Typ der Indirektheit unterscheidet sich konzeptionell von den ersten drei. Er liegt vor, wenn zwischen Interventionen gewahlt werden muss, die nicht im direkten Vergleich zueinander untersucht wurden. In solchen Fallen werden fur den Vergleich von Behandlungen spezifische statistische Methoden benotigt, die jedoch zu einer Abwertung der Qualitat von einer oder zwei Stufen fuhren konnen. Eine Herabstufung hangt vom Umfang der Unterschiede zwischen den Patientenpopulationen, den begleitenden Interventionen, der Ergebnismessung und der Studienmethodik der in Frage kommenden Intervention im Vergleich zu einem anderen Komparator ab.Direct evidence comes from research that directly compares the interventions in which we are interested when applied to the populations in which we are interested and measures outcomes important to patients. Evidence can be indirect in one of four ways. First, patients may differ from those of interest (the term applicability is often used for this form of indirectness). Second, the intervention tested may differ from the intervention of interest. Decisions regarding indirectness of patients and interventions depend on an understanding of whether biological or social factors are sufficiently different that one might expect substantial differences in the magnitude of effect. Third, outcomes may differ from those of primary interest - for instance, surrogate outcomes that are not themselves important, but measured in the presumption that changes in the surrogate reflect changes in an outcome important to patients. A fourth type of indirectness, which is conceptually different from the first three, occurs when clinicians must choose between interventions that have not been tested in head to head comparisons. Making comparisons between treatments under these circumstances requires specific statistical methods and will be rated down in quality by one or two levels depending on the extent of differences between the patient populations, co-interventions, measurements of the outcome, and the methods of the trials of the candidate interventions against some other comparator.

PSM4 HEALTH ECONOMIC MODEL OF SMOKING CESSATION TREATMENT WITH VARENICLINE IN GERMANY

pies. The transition probabilities of morbidity and mortality and the efficacy were taken from published studies. The model allows cost effectiveness analyses for different time frames (10 years, 20 years and life time). Outcomes are measured in terms of incremental life years gained (LYG) and QALYs. Pharmacological costs and costs of medical visits for the treatment with varenicline and bupropion were considered. Treatment costs of smoking associated morbidity were taken from Spanish studies. Results were expressed in terms of incremental cost per life year gained and incremental cost per QALY of varenicline versus comparators. The analyses were done under the perspective of the National Health System, discounting costs and health benefits at 3 percent. RESULTS: The life time cost-effectiveness analysis shows that varenicline dominates all other smoking cessation interventions (more effective at a lower cost). This is due to the higher efficacy of varenicline associated with a reduction in smoking related morbimortality, which, in the long term, accounts for health care cost savings that overcome the extra cost of varenicline. When shorter timeframes are considered, varenicline presents values under 9.000 €/QALY and 50.000 €/QALY (analyses at 20 and 10 years respectively). CONCLUSION: Varenicline is a dominant option (more effective at a lower cost) compared with all other smoking cessation treatments when the timeframe is the life span of the patient. Varenicline is costeffective even when shorter timeframes are considered (20 years or more), with an estimated incremental cost per QALY well bellow the threshold commonly accepted in our environment: 30,000 €/QALY.

Rauchen und gesundheitsbezogene Lebensqualität: ein systematisches Review

Fragestellung: Die Studie gibt einen Uberblick uber den aktuellen Forschungsstand zur Assoziation des Rauchens und gesundheitsbezogener Lebensqualitat. Methodik: Es wurde eine systematische Recherche in der MEDLINE-Datenbank (mit anschliesender Handrecherche) durchgefuhrt. Ergebnisse: Es werden 24 Publikationen in die Analyse eingeschlossen. Die Lebensqualitat wird uberwiegend mittels SF-36 erfasst. Insgesamt berichten 23 Studien eine signifikant negative Assoziation des Rauchens und gesundheitsbezogener Lebensqualitat. Zehn dieser Publikationen belegen den signifikant negativen Zusammenhang in allen untersuchten Lebensqualitatsbereichen. Neben dem Raucherstatus konnen auch signifikante Assoziationen mit der Dauer und der Intensitat des Tabakkonsums sowie der Abstinenzdauer festgestellt werden. Inwieweit eher psychische oder physische Dimensionen starker mit dem Rauchen korrelieren, kann abschliesend nicht beantwortet werden. Schlussfolgerungen: Die Studien bestatigen die Annahme, ...

Cost-effectiveness of smoking prevention measures in adolescents

IntroductionIn view of the serious health risks and high costs to the health care system of tobacco consumption, getting young people to avoid smoking is an important element of preventive health care. The aim of this study was to give an overview of the scientific literature on cost-effectiveness in smoking preventive interventions within this age group.MethodsA literature search was conducted in publicly available databases.ResultsEight studies confirming the cost-effectiveness of those programmes were identified. These publications evaluate behaviour-based as well as environment-related interventions. Depending on the specific measures used, the results varied enormously. Nevertheless, in most scenarios the cost-effectiveness was favourable with less than 20,000 euros per life year gained (LYG) or quality-adjusted life year (QALY). In the long-term perspective some studies estimate significant cost savings from a societal perspective.ConclusionAccording to the available evidence, the authors assume that smoking prevention in adolescents is cost-effective. Due to the small number of comparable studies, there is a lack of reliable evidence regarding the economic aspects of primary tobacco prevention.

Subgruppen in der frühen Nutzenbewertung von Arzneimitteln: eine methodische Bestandsaufnahme

Benefit assessments according to Sect. 35a of the Social Code Book V are frequently divided into subsets of populations. This division of therapeutic indications is evident in almost every other of the completed appraisals by the Federal Joint Committee (G-BA). The subsets can be deduced from the wording of the approved therapeutic indication (subpopulations) or from potential effect modification (subgroups). Methodological challenges are illustrated on the basis of current scientific knowledge of how to tackle subgroups. Practical assessment examples are used to explain the methods implemented by IQWiG and the G-BA and reveal major problem areas concerning subgroup analyses, subpopulations as well as mismatches between the requirements of early benefit assessment and approval. Overall, it appears there is a need for establishing a more comprehensive discussion regarding the validity of subgroup analyses and their associated limitations.

PMC50 MEASUREMENT OF OUTPATIENT REHABILITATION OUTCOMES WITH EQ-5D

assumption of impractical unlimited vaccine supply, we developed a generalized methodology based on dynamic stochastic model utilizing the flow of limited vaccine supply to the individuals between two mutually exclusive subgroups (e.g. different age groups or different risk groups) in order to examine the long term impact of different vaccination programs on overall health outcomes from the whole population. In this model, both age dependency and seasonality in FOI were explicitly considered. This study aims to answer two key questions: 1) what is the best vaccination strategy in order to attain maximal quantitative post-vaccination health benefits among two subpopulations? and 2) how different structures of age-specific FOI’s influence our selection on the vaccinated population? Most of the time, one needs to have various parameter values in the models targeting spreading of infectious diseases in populations which cannot be estimated accurately. Therefore, a series of scenarios with different FOI’s, demographic structures, vaccine efficacy and other model parameters were used in our simulation studies using this stochastic age-structured framework. In summary, our study dynamically acquired both important biomedical and mathematical implications by successfully analyzing the current mass vaccination strategy, evaluating the effect of different prevention and intervention options, and served as an accurate basis for outcome research that may facilitate further costeffectiveness analysis.