Karl W. Lauterbach

Cost-effectiveness of FDG-PET for the management of potentially operable non-small cell lung cancer: priority for a PET-based strategy after nodal-negative CT results

Abstract. Decision analysis is used here to establish the most cost-effective strategy for management of potentially operable non-small cell lung cancers (NSCLCs). The strategies compared were conventional staging (strategy A), dedicated systems of positron emission tomography (PET) using fluorine-18 fluorodeoxyglucose (FDG) in patients with normal-sized (strategy B) or in patients with enlarged mediastinal lymph nodes (part of strategy C), and FDG-PET followed by exclusion from surgical procedures when both computed tomography (CT) and PET were positive for mediastinal lymph nodes (strategy D) or when PET alone was positive (strategy E). Based on published data, the sensitivity and specificity of FDG-PET were estimated at 0.74 and 0.96 for detecting metastasis in normal-sized mediastinal lymph nodes, and at 0.95 and 0.76 when these lymph nodes were enlarged. The calculated probability of up-staging to M1 by using PET was 0.05. The costs quoted correspond to the cost reimbursed in 1999 by the public health provider in Germany. The incremental cost-effectiveness ratio (ICER) of strategy B was much more favourable (143 EUR/LYS; LYS = life year saved) than the ICER of strategy C (36,667 EUR/LYS). In strategy B, the use of PET did not raise the overall costs because the costs of PET were almost balanced by a better selection of patients for beneficial cancer resection. The exclusion from biopsy confirmation in strategies D and E led to cost savings that did not justify the expected reduction in life expectancy. In sensitivity analyses, the ICERs of strategy B were robust to the pretest likelihood of N2/N3, to penalized test parameters of PET and to reimbursement of PET. However, the ICER of strategy B would be raised to 28,000 EUR/LYS through use of thoracic PET without whole-body scanning. To conclude, the implementation of whole-body PET with a full ring of detectors in the preoperative staging of patients with NSCLC and normal-sized lymph nodes is clearly cost-effective. However, patients with nodal-positive PET results should not be excluded from biopsy.

Threshold volumes associated with higher survival in health care: a systematic review.

Background. To date, systematic reviews on the relationship between the volume of specific diagnoses and procedures and patient outcomes have several limitations, including the omission of the most recent publications. Objective. To investigate the relationship between hospital and physician volume and patient mortality rate for all diagnoses and interventions in health care. Research Design. Medline and the Cochrane Library were searched from January 1990 to December 2000 for all studies published in Dutch, English, French, German, and Italian. The following Boolean search statement was used:hospitals AND volume AND (outcome OR mortality OR quality). Studies were included in which patient enrollment ended within 10 years of the current study and that were adjusted for case-mix. For each diagnosis and intervention, the study most likely to provide an unbiased estimate of the effect of volume on mortality rate was identified using a specific algorithm (best study). Results. A total of 34 diagnoses and interventions with at least one qualifying study on the volume–outcome relationship were identified. The summary odds ratio/relative risk for the best studies on hospital and physician volume were 0.87 (95% confidence interval [CI], 0.85–0.89) and 0.87 (95% CI, 0.81–0.94), respectively. From the best studies on hospital volume, 48.5% (16 of 33) were published either in 1999 or 2000. Conclusions. There is evidence for a volume–mortality relationship for hospitals and physicians. The use of appropriate methods for analyzing additional diagnoses and interventions as well as a continuous systematic evaluation of the evidence is recommended.

Deutsche Empfehlungen zur gesundheitsökonomischen Evaluation

Zusammenfassung□ Finanzielle Restriktionen und eine stärkere Ergebnisorientierung erfordern mehr und mehr rationale Entscheidungen über den Mitteleinsatz im Gesundheitswesen. Solche Entscheidungen sind Gegenstand medizinischer, ethischer und wirtschaftlicher Erwägungen. Die Steuerung des Gesundheitswesens bedarf sowohl auf gesamtwirtschaftlicher Ebene der medizinischen und wirtschaftlichen Orientierung als auch bei der Auswahl von geeigneten Versorgungsformen in Klinik und Praxis. Die evaluative Gesundheitsökonomie kann dabei ein wichtiges Hilfsmittel zur Entscheidungsfindung sein.□ Damit die Ergebnisse von gesundheitsökonomischen Evaluationsstudien valide interpretiert werden können, ist ein Mindestmaß an gemeinsamer Methodik und ausreichender Transparenz erforderlich. Zu diesem Zweck wurden Empfehlungen entwickelt. Sie sollen einerseits Standards vermitteln, andererseits den methodischen Fortschritt und die wissenschaftliche Freiheit in der Gesundheitsökonomie nicht unnötig einengen.□ Für die Zukunft ist eine ständige Weiterentwicklung der Empfehlungen und ihre Anpassung an den jeweiligen Stand der gesundheitsökonomischen Forschung anzustreben.Abstract□ Financial restrictions and stronger orientation towards outcomes increasingly demand rational decisions to be made about the use of resources in the health care system. Such decisions are the subject of medical, ethical and economic considerations. Management of the health care system requires medical and economic orientation both at the general level and with regard to the selection of suitable forms of care in hospital and medical practices. In this context, evaluative health economics can be a valuable decision-making aid.□ In order for the results of health economic evaluation studies to be validly interpreted, a minimum of standard methodology and sufficient transparency is required. To this end, recommendations were developed. They are intended to convey standard approaches, without unnecessarily constraining methodologic progress and scientific freedom.□ Ongoing refinement of the guidelines and adaptation of the current state of health economic research are desirable.

Management Patterns and Health Care Use after Intracerebral Hemorrhage

Background: The German cost-of-illness study of stroke is a multicenter study in 6 departments of internal medicine, 9 departments of general neurology and 15 departments of neurology with an acute stroke unit. The aims of this study are to describe the management patterns, cost of treatment and overall resource utilization after intracerebral hemorrhage (ICH) as well as the major differences to ischemic stroke (IS). Methods: During a 12-month period, 30 participating centers with a special interest in stroke prospectively included 586 patients with ICH which were collected in a joint data bank. About 75% of all patients could be centrally followed up via structured telephone interviews after 3 and 12 months to assess further acute hospital and rehabilitation stays, outpatient resource utilization, functional outcome and quality of life. Results: Mortality after 3 months (33.5%) was markedly higher than in patients with IS from the same hospitals. Accordingly, only 30.9% of patients had regained independent functional status after 3 months. Cumulative cost of treatment amounted to 5,301 EUR for inpatient stay in the documenting hospital and 8,920 EUR for the overall hospital stay including rehabilitation. Mean direct cost after discharge during the first year amounted to 4,598 EUR and the loss of work force was equivalent to 5,537 EUR in all surviving patients. Conclusion: This study provides a comprehensive overview of patient characteristics, treatment strategies and health care cost of ICH from a societal perspective in Germany.

Diabetes—prevalence and cost of illness in Germany: a study evaluating data from the statutory health insurance in Germany

Objective  This population‐based study assesses the prevalence and cost of illness as a result of diabetes mellitus in Germany by retrospectively analysing routine health insurance data. Prevalence and costs were analysed from statutory health insurance (GKV) and societal perspectives.

Review of Quality-of-Life Evaluations in Patients with Angina Pectoris

AbstractPatients with angina pectoris have a reduced quality of life because of their symptoms, impaired activity and anxiety. However, there is no consensus on the best method of measuring quality of life. A systematic literature search of randomised controlled trials (RCTs) in angina showed that the most common generic questionnaire was the Nottingham Health Profile (NHP) Part 1, and the most common angina-specificmeasure was the Quality-of-Life after AcuteMyocardial Infarction Questionnaire. A comparison of NHP scores with those of the healthy population revealed that patients with angina particularly seem to experience a lack of energy, poor sleep and decreased physical mobility. In the RCTs evaluated, antianginal drugs did not show a significant benefit over placebo in terms of quality of life. As a result of a lack of valid data from RCTs, a strong conclusion regarding the impact of revascularisation procedures on quality of life could not be derived.

Kosten koronarer Herzkrankheiten über die verbleibende Lebenszeit von KHK-Fällen – Eine Analyse des aktuellen Bestandes an KHK-Fällen in Deutschland aus gesellschaftlicher Perspektive

Cardiovascular diseases are the major cause of death not only in Germany. Coronary heart diseases result in substantial disability and loss of productivity and contribute to escalating costs of health care. Objective: It was out objective to estimate the costs of CHD for the German population from the perspective of the society. The characteristic of this approach is the calculating of costs until the approximated end of life. Methods: In the study, all health care costs concerning CHD in Germany were allocated to age, sex, health care sector and primary diagnosis on the basis of comprehensive data on morbidity, mortality, direct and indirect costs. For the estimate of indirect costs the human capital approach was taken. Considered as cases were all patients hospitalized in the reference year (1996). The costs of this cohort in 1996 and up to their protected end of life were estimated. It was taken into account that, in comparison to the general population, life expectancy of cases with risk factors of CHD would have been reduced. In calculating indirect costs, gender and age specific unemployment rates were considered. All future costs were discounted by 4% from the reference year onward. Results: Direct costs are approximately 39 billion DM discounted at 4%, indirect costs total 73 billion DM. The average cost per case (including morbiditiy and mortality) until the approximated end of life is nearly 125,000 DM. Conclusion: In our cost analysis, the indirect costs are higher than the direct costs. For the future, it will be important to estimate the costs of prevalent cases until the end of life and to compare the influence of different interventions on these parameters and on the whole budget of the social security system. Herz-Kreislauf-Erkrankungen sind in der Bundesrepublik die häufigste Todesursache. Trotz rückläufiger KHK-Mortalität steigt die Zahl der Patienten weiter an. Ziel: Um die ökonomische Relevanz der KHK in Deutschland zu bewerten, werden in der vorliegenden Kostenanalyse die direkten und indirekten Kosten über alle Altersgruppen ermittelt. Die Besonderheit dieser Analyse liegt darin, daß die Kosten aller im Basisjahr prävalenten Fälle (alte und neue Fälle) über die erwartete Restlebenszeit der betrachteten Patienten ermittelt werden. Methode: Es wird die gesellschaftliche Perspektive gewählt. Die direkten Kosten werden für die einzelnen Sektoren des Gesundheitswesens getrennt ermittelt. Indirekte Kosten in Form von Produktivitätsausfällen werden unter Verwendung des Humankapitalansatzes berücksichtigt. Darüber hinausgehende Kosten werden in die Berechnungen nicht einbezogen. Den Berechnungen liegt die Gesamtheit aller im Basisjahr (1996) vorkommenden KHK-Fälle zugrunde, ganz gleich, ob es sich dabei um alte oder neue Fälle handelt. Die Kosten des Basisjahres werden über die verbleibenden Lebensjahre fortgeschrieben. Dabei wird der Tatsache Rechnung getragen, daß die Lebenserwartung aufgrund von die KHK begünstigenden Risikofaktoren bzw. der eingetretenen KHK gegenüber der durchschnittlichen Lebenserwartung der Bevölkerung verkürzt ist. Des weiteren wird die Alters- und Geschlechtsverteilung der KHK-Ereignisse, die alters- und geschlechtsspezifische Erwerbsquote und die Zahl der Berufsaussteiger berücksichtigt. Alle in Zukunft zu erwartenden Kostenkomponenten werden mit 4% p. a. diskontiert. Ergebnis: Als Ergebnis erhält man die Kosten, welche die im Basisjahr prävalenten KHK-Patienten in den verbleibenden Lebensjahr insgesamt verursachen. Dies sind insgesamt 113 Mrd. DM. Davon sind rd. 39 Mrd. DM den direkten und rd. 73 Mrd. DM den indirekten Kosten zuzurechnen. Die durchschnittlichen Kosten je KHK-Patient (Morbidität und Mortalität) über die verbleibende Lebenszeit belaufen sich damit auf rund 125 000 DM. Schlußfolgerung: In dieser Analyse sind die indirekten Kosten der KHK höher als die direkten Kosten. Interessant ist besonders die Perspektive der entstehenden Restkosten über die verbleibende Lebenszeit. Auf der Basis der vorliegenden Analyse ist es möglich, eine zukünftige Abschätzung vorzunehmen, ob und um wieviel eine neu eingeführte Intervention die Restkosten der prävalenten und neuen Fälle erhöht oder senkt. Hiermit können auch die Auswirkungen präventiver und therapeutischer Verfahren auf das Gesamtbudget untersucht werden. Darüber hinaus kann die Kostenanalyse als Grundlage für die Bedarfsplanung herangezogen werden.

Economic evaluation studies in nuclear medicine: the need for standardization

Abstract. The guidelines for publishing economic evaluations require a statement of the economic importance of the analysis and the viewpoint from which it has been carried out, as well as specification of at least two alternative programmes or interventions, the form of economic evaluation, the outcome measure, the method of costing, the time horizon and adjustment for timing of costs and benefits (e.g. by a discount factor), and the allowance for uncertainties (e.g. by implementation of a sensitivity analysis). The decision analysis can be based on clinical trial data, on retrospective or administrative databases, or on modelling. The choice of outcome measures is the key issue in an economic evaluation. In cost-effectiveness analysis, benefits are usually measured in natural units. This is the form of economic evaluation most frequently used in nuclear medicine. Endpoints of effectiveness applied in studies in this field have been procedures avoided, procedures initiated, cardiac events, survival probability, morbidity, quality of life and protracted or failed surgical procedures. In other instances, surrogate endpoints have been used such as metastases detected, staging, viability or tumour response. This, however, limits comparability of cost-effectiveness considerably, as proof of a change in the health outcome cannot be obtained. Measures of utility such as QALYs (quality-adjusted life years) have so far only been applied for decision tree analysis. Useful examples of economic evaluation studies in nuclear medicine are presented here for fluorodeoxyglucose positron emission tomography (FDG-PET) in the preoperative staging of non-small cell lung cancer, for FDG-PET in differentiating indeterminate solitary pulmonary nodules, for somatostatin receptor scintigraphy in detecting metastases of carcinoid tumours, for routine preoperative scintigraphy with sestamibi in patients with parathyroid adenoma, for periodic measurement of thyroid-stimulating hormone in detecting mild thyroid failure, for diagnostic algorithms including a lung scan in patients with suspected pulmonary embolism, for myocardial perfusion imaging as an incremental prognostic factor in patients with coronary artery disease, and for the use of radioiodine as first-line therapy of Graves’ hyperthyroidism and of toxic nodular goitres. Further evaluations of effectiveness or utility should be carried out within a multidisciplinary framework to ensure that nuclear medical procedures are included in the general management guidelines.

When Is It Worth Introducing a Quality Improvement Program? A Mathematical Model

Quality improvement programs must compete with other health care interventions for limited health care resources. The goal of the research presented here was to develop a model that portrays the mathematical relationship between the size of a quality deficit caused by the noncompliance of health professionals and the cost-effectiveness of a quality improvement program. The model allows the determination of the minimum size of a quality deficit for which it is worth introducinga quality improvement program. If a quality improvement program has already been implemented, the model can be used to define the quality threshold beyond which a reduction in quality becomes economically unattractive. An example consideringthe reduction of underuse in depression treatment demonstrates that an intervention with a favorable cost-effectiveness ratio may become economically unattractive once the costs for the implementation effort are considered.

Economic Evaluation of the Treatment of Chronic Wounds Hydroactive Wound Dressings in Combination with Enzymatic Ointment Versus Gauze Dressings in Patients with Pressure Ulcer and Venous Leg Ulcer in Germany

AbstractObjective: The treatment costs for pressure ulcers and venous leg ulcers were estimated based on the hospital administrator’s perspective in Germany. Design: Aspreadsheet model using input data from various hospitals in Germany was developed. Interventions: Five currently used treatment strategies were analysed: gauze, impregnated gauze, calcium alginate and hydroactive wound dressing with enzymatic ointment. Participants: All cases used for and in the analysis were treated in the inpatient setting (4 hospitals and 120 patients were included). Main outcome measures and results: The outcome distributions were calculated using the Monte Carlo method. For the whole treatment process, the attributable costs for the hospital were calculated for different cases (severity) and all treatment strategies (1997 values).The costs for treatment with gauze were the highest, whereas the costs for treatment with hydroactive wound dressings and enzymatic ointment were the lowest. The relation between personnel and material costs for gauze is approximately 95 to 5% and for hydroactive wound dressings 67 to 33%, respectively. The cost savings per case were between 1196 deutschmark (DM) and DM9826 using hydroactive wound dressings instead of gauze dressings (depending on the severity of the pressure ulcer), and between DM135 and DM677 for venous leg ulcers. The results were robust and did not change in any performed sensitivity analysis (parameter: ‘personnel costs per minute’, ‘time required for changing a wound dressing’, ‘total number of wound dressing changes’). Conclusions: Despite the higher material costs of the hydroactive wound dressings in combination with enzymatic wound cleaning compared with other wound dressings, they should be recommended for the treatment of pressure ulcers and venous leg ulcers. This therapy alternative brings about significant reductions in total costs for hospitals because of significant reductions in personnel costs and the duration of treatment.