, Bern Bea. SULM Tagung: Nutzen der Labormedizin Labor und Outcome

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1 Akkreditierung ISO/IEC ISO STS 0264 Swiss Medlab , Bern Bea SULM Tagung: Nutzen der Labormedizin Labor und Outcome Andreas Huber

2 Outcome Ergebnis, Endergebnis Überprüfung von Wirksamkeit und Eignung einer Massnahme (Operation, Eingriff, Therapie, Medikation, Test) Bewertung eines Entscheides Something that happens as a result or consequence of an activity or process

3 Where does outcome happen? The 4 C Community Patient & Relatives Control Hospital Management Cure Doctors Care Nurses Adapted from Glouberman S, Health Care Mgmt Rev 2001

4 Customized Personalized Medicine using the lab OPTIMIZED risk-adapted medicine with biomarkers in a integrated, clinical interdisciplinary and multiprofessional setting applicable in real-life for most patients Meier-Abt P. 2014, adapted BM

5 Time is one critical factor for outcome Admission Labtesting Radiology Labtesting Treatment Imaging Pharmacy Discharce Anamnese Ops Bericht Kernprozess Patientenpfad For patient and cost Röntgen Mikrobiologie Pathologie Radiotherapie Medikation

6 Steps for lab test development Ges. Outcome Klin. Outcome Bayes Theorem (PPW / NPW) Charakterisierung des Tests (Sens. / Spez. ) Methoden-Entwicklung Pathophysiologie Grundlagenforschung

7 Important benefits of laboratory medicine There is an urgent need for additional studies, especially when introducing new methods (pressure from competition, regulators, ). Analytic and diagnostic characteristics are not enough. Outcome studies: Performing laboratory tests leads e.g. - Reduction of mortality, morbidity - Reduction of lenghts of hospital stay - Reduction of medication (spending) - Guidance for appropriate nursing care, Flow - Reduction of other means (Radiation, X-ray, MRI, CT, etc.) - Reduction of side effects of drug therapy - Reduction of health care spending overall - Improvment of quality of life - Release of presure on relatives, community Of note: Aim is not investigation of sensitivity/specificity /PPV/NPV/LR

8 Some examples of outcome studies Nr Parameter Topic Bewertung Quelle 1 Lc Harnwegs-Infekt Bedeutung von Biomarkern [1] 2 PCT Infekt Wertigkeit von PCT bei Infekten [2] 3 PCT Harnwegs-Infekt Wertigkeit von PCT bei speziellen Infekten [3] 4 Lc Harnwegs-Infekt Einsatz von Lc-Zahl bei Harnwegs-Infekt [4] 5 PCT Harnwegs-Infekt Gezielte Antibiose, optimierte Behandlungsdauer sowie gesteuerte empirische Therapie [5] 6 PSA Prostata CA Konzentrationsabhängiges Screening mit Stufenschema [6] 7 BCR-ABL CML Steuerung der Therapie mit Tyrosinkinase Blocker [7] 8 Copeptin Hypo-natriämie Beurteilung des Verlaufs [8] 9 Proadrenomedullin Community-Acquired Pneumonia Alogrithmus zusammen mit klinischem Score [9] 10 PSA Prostata CA Überlebensvorteil und mehr QUALY dank PSA gesteuerter Behandlung [10] 11 Mehrere Biomarker Pneumonie Verbessertes Management des Patienten in der Notfallstation [11] 12 Mehrere Biomarker Herz-insuffizien Verbesserung der Hospitalisationsdauer [12] 13 PCT Pneumonie Bessere Behandlungsstrategie im Notfall und Spital [13] 14 Mehrere Biomarker Mehrere Krankheiten Übersichtsartikel [14]

9 Gesellschaftlicher (monetärer) Outcome 3 % 3.5% 3 % 3.5% 38.6% 38.8 % 97 % 96.5% Kosten Labormedizin Kosten Gesundheitswesen Die Laborkosten betragen etwa 3% der Kosten des Gesundheitswesens % 57.9% Laborbefunde steuern in 60% der Fälle die klinischen Entscheide.

10 Nutzen: Prävention, Diagnose, Monitoring Erfassung Risiko-faktoren Früh-Diagnose Spezifische Tests Monitoring Präventive Medizin Präklinische Medizin Diagnose Therapie Klinische Medizin

11 Einsatz von Labortests Krankheit / Frage Parameter als Beispiel Ausschluss Infarkt Prostata Carcinom Myoglobin PSA Diagnose Infarkt Infekt Troponin Mikrobiologie Stratifizierung Monitoring Atemnot Dickes Bein Fieber Malignom Medikation HIV BNP D-Dimere PCT Tumormarker Medikamenten-Spiegel Viralload und CD4/8

12 Nutzen: Weichenstellung / Patientenpfad Symptom Labor- Determinator Massnahme Laborkontrolle Manual Doppler- Ultraschall Blutverdünnung Wirkung Guideline C Guideline D Dickes Bein D-Dimer D-Dimer Guideline E (Gerinselabbauprodukt) Guideline F Rheumatologie Guideline H

13 EINIGE JÜNGSTE BEISPIELE VON LABOR UND OUTCOME

14 The BRUTUS study T. Kahles, J. Kejda-Scharler, K. Nedeltchev, L. Bernasconi, A. Huber, P. Schütz, B. Müller, M. Katan Biomarker Signature for RescUe Therapy in Wake-Up Stroke Background Thrombolysis is only effective in strokes with symptom onset < 4.5h. In 25% time of symptom onset is unknown (=WUS) à thrombolysis is contraindicated. Blood biomarkers may reflect aspects of stroke pathophysiology and evolution in time & space Aim Identification of WUS, which are still eligible for i.v. thrombolysis using blood biomarkers.

15 The EFFORT Project (Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial) Prof. Dr. med. Philipp Schütz & Team MUK Endocrinology, Diabetes and Clinical Nutrition & Internal Medicine, Medizinische Universitätsklinik, Kantonsspital Aarau SNF Professorship

16 EFFORT Nutritional Screening with NRS Inclusion (N = 3000) NRS 3 Estimated LOS 8 days Informed Consent Randomisiation Intervention Individualized early nutrition along guidelines Control Nutrition according kitchen and patient s will Daily reassessment, Blinded interviews after 30 und 180 days

17 ProADM improves the prognostic posttest accuracy of the PSI Score to predict mortality Pre-test Probability LR Post-test Probability CAP PSI I-III ~ 1% CAP overall ~ 7% CAP PSI IV-V ~ 20% ProADM < 1.8 nm LR ProADM > 1.8 nm LR % 20 % 3 % 0.2 % ICU? Outpatient? Fagan. NEJM 1975; 293: 257

18 Etiology and prognosis of LRTD Krankheit Setting Erkältung Bronchitis Pneumonie Sepsis Hausarzt Notfallstation Spital IPS Ambulant Diagnose Infektion? Therapie Antibiotika? Management Prognose? Stationär IPS Prävalenz viral Mortalität bakteriell EU 500Mio 50Mio 5Mio 0.05Mio <<1% <1-3% 5-20% 30-70% Medicine is the science of uncertainty and the art of probability. Sir William Osler, 1902

19 Prognostic Biomarkers in LRTI Prediction of Mortality & SAE (PSI & CURB65: validated only for mortality in CAP) à Biomarkers predict both outcomes in CAP & LRTI ProHOSP, LRTI n=1359

20 OPTIMA Imagine this RISK would be YOU -3d: Cough, dyspnea, sputum T: 38.8 C, basal crackles (!?) 8-9h: 9h: Culture (sputum, blood)? WBC, CRP, other? Antibiotics? Hospitalisation?

21 Risk-adapted Antibiotic Therapy? Hausarzt! ( Gatekeeper ) Overruling? (High-risk, Co-Morbidities) Diagnosis Respiratory Infection? Therapy Antibiotics? Clinical Exam (pivotal & valuable!) Procalcitonin ( hormonal Biomarker ) Signs & Symptoms Acute Bronchi>s Cultur, serology COPD Exazerba>on Radio -logy CAP Pneumonia < STOP An>bio>cs Stop/Start based on Algorithm START An>bio>cs

22 Risk-adapted Medicine Family Physician! ( Gatekeeper ) Overruling (High-risk, Co-Morbidities) Overruling (Wish of patients & relatives) Diagnosis Respiratory Tract Infection? Therapy Antibiotics? Management Hospitalisation? OPTIMA History & Clinical Exam (essential!) Procalcitonin (Grenzbereiche) Prognost. Assessment (Scores, Biomarker, Pflege) Signs & Symptoms Culture, Serology Radio -logy < Sehr >ef Tief Hoch Sehr hoch Acute Bronchi>s COPD Exacerba>on CAP Pneumonia STOP An>bio>cs Stop/Start based on Algorithm START An>bio>c Outpa>ent Short stay NLU / Rehab Home-Nursing Hospital. ICU

23 14 RCTs 4221 patients with acute RTIs Safety! Efficacy! Schuetz P, et al, Clin Infect Dis & Cochrane Syst DB 2012 & JAMA 2013

24 If PCT would be used in real life for RTI... 95%? Reduced AB-Prescription using PCT-Guidance 75% Asia! USA! Latin America! PCT PARTI - study, Briel M., Arch Int Med 2008 Filippini M, Health Policy, 2006

25 What are good Predictors of Bloodculture positivity? Collection of 2x2 blood cultures in 925 patients with CAP 91% negative blood cultures (n=844) 9% positive bood cultures (n=81) (84% Strept. pneumoniae) Sensitivity Specificity Clinical predictors AUC Age: 0.55 BD systolic: 0.63 Previous AB: 0.59 Temperature: 0.61 Risk predictors PSI: 0.55 Biomarkers Leukocytes: 0.57 CRP: 0.67 PCT 0.83 Müller F. (in preparation)

26 Multimarker-Approach AUC s for detection of a bacterial cause of inflammation: 0.50 ( ) 0.61 ( ) 0.63 ( ) 0.74 ( ) 0.72 ( ) 0.81 ( ) 0.84 ( ) 0.88 ( ) Kofoed et al., Crit Care 2007

27 Schlussfolgerungen Biomarker haben ein grosses Potential wichtige Outcomes zu generieren Mehr Studien sollten auf diese Aspekte fokussieren Ärzte, Krankenkassen, Politiker und Gesundheitsökonomen sollten die Steigerung des klinischen Mehrwertes durch Labortests kennen Morbidität, Mortalität, LOS, Behandlungseffizienz, Elimination unnötiger (teurer) Massnahmen Verbesserung des Patienten-Flows (ICU, Homecare, Notfall, NLU, Ambulant, stationär) Dx-Industrie sollte neue Marker und Tools entwickeln, die den Outcome verbessern

28 Medicine is the science of uncertainty and the art of probability. Sir William Osler, 1902 Lab-testing should reduce uncertainty and increase probability. Andreas Huber, 2016

29 Red carpet!

30 Thanks for your attention!