Two meaningful outcomes in healthcare: EFFICACY and EFFECTIVENESS
Clinical Economics: it is about value, not about money
During the past 25 years, the medical profession has been subjected to an economizing process. Economization was considered to be a new type of healthcare management and was well defined by Porter & Teisberg (Porter & Teisberg 2006): “The original idea of ‘managed care’ was simple and elegant – a primary care physician close to the patient would ensure that the care delivered was neither too much nor too little, involved appropriate specialists, and reflected the individual patient’s needs and values.” This brief description of the actual service provided by the managed-care concept requires the difficult balance between too much and too little in patient care. Monetary aspects cannot be found in this original concept, in which, the authors speak of a service provided by a physician. We postulated a nearly identical content in the field of medical oncology (Porzsolt et al. 1993), referred to as “Clinical Economics” (Porzsolt 1994; Porzsolt & Kaplan 2006).
The term Clinical Economics describes the physicians’ contributions in guiding the healthcare system. This system functions when both physicians and economists make complete economic decisions. The complete economic analysis includes three components: what has to be given up (the costs), what will be gained (the consequences), and comparison of at least two possible options (e.g. two different treatments). Figure 1 shows that physicians’ decisions have to include patients’ perspectives, which are related to non-monetary values. The economists’ decisions have to include the institution’s or company’s perspectives and are related to monetary values. It is plausible that physicians’ and economists’ decisions require specific viewpoints, skills, and knowledge and can neither be exchanged nor replaced by each other. The medical and financial success of the institution will depend on the synergism between physicians and economists. The difficult part of this synergism has to be contributed by physicians. They have to provide the evidence that confirms the value of health care. At this point, the Pragmatic Controlled Trial (Porzsolt et al. 2015) can make an essential contribution; it enables the assessment of the patient benefit generated under real-world conditions.
We have to work on the changed relationship between the medical profession and the public as requested by Donald Irvine, President of the Royal Society of Medicine (Irvine 2001): “What has not changed is the fact that the public need doctors who are knowledgeable and skilled, ethical and committed… We have to start respecting and understanding each other’s values and motives …” Five major actions were suggested to re-form the relationship between the medical profession and the public (Porzsolt 2016): (a) consensus to describe real-world effects (effectiveness) by ’Pragmatic Controlled Trials’ (Porzsolt et al. 2015), (b) when there is a lack of effectiveness data, the critical appraisal of the validity of efficacy data should be mandatory to avoid commercial and academic conflicts of interest, as well as harm to patients and the public (Porzsolt et al 2012),. (c) no use of surrogate parameters unless the correlation with the endpoint has been demonstrated, (d) the ‘Supplementing the Choosing Wisely’ strategy by real-world outcome data and by incentives, such as re-investment of the saved resources (Porzsolt & Correia 2016), and (e) ‘Perceived Safety’ (Fig. 2) is a basic human need, an important patient value and an ethical challenge to doctors and the system (Porzsolt 2015). The proposed Safety Loop reflects Gray’s statement ‘values control decisions’ (Gray 2004). Healthcare is primarily about value, not money.
Gray JA Muir (2004) Evidence based policy making. BMJ 329:988-989
Irvine D (2001) The changing relationship between the public and the medical profession. J R Soc Med 94:162-169
Porter M, Teisberg E (2006) Redefining Health Care – Creating Value-Based Competitionon Results, Harvard Business School Press, p.76
Porzsolt F (1994) Klinische Ökonomik – Eine Forderung der Gesellschaft an die Ärzte. Münch med Wschr 136: 221-225.
Porzsolt F, Ohletz A, Thim A, Gardner D, Ruatti H, Meier H, Schlotz-Gorton N, Schrott L (2003): Evidence – based decision making. The six step approach. Editorial. Evidence-Based Medicine 8:165-6.
Porzsolt f, Kaplan RM (2006) „CLINECS“: Strategy and Tactics to provide Evidence of the Usefulness of Health Care Services from the Patient’s Perspective (Value for Patients). In: Porzsolt F, Kaplan RM (eds.) Optimizing Health – Improving the Value of Healthcare Delivery. Springer, New York, pp 1-9
Porzsolt F, Braubach P, Flurschütz PI, Göller A, Sailer MB, Weiss M, Wyer P (2012) Medical Students Help Avoid the Expert Bias in Medicine. Creative Education 3:1115-1121 doi:10.4236/ce.2012.326167
Porzsolt F (2015) Evidence-based Risk Management: safety means “perception of risk”.
4th World Congress on Clinical Safety, Vienna/Austria, Sept 28-30.
Porzsolt F, Rocha NG, Toledo-Arruda AC, Thomaz TG, Moraes C, Bessa-Guerra TR, Leão M, Migowski A, Araujo de Silva AR, Weiss C (2015) Efficacy and Effectiveness Trials Have Different Goals, Use Different Tools, and Generate Different Messages. Pragmatic and Observational Research 6:47-54
Porzsolt F (2016) Klug entscheiden – Nutzen mehren. Dtsch Ärztebl 2016;113:A1705.
Porzsolt F (2016) Clinical Economics – It is about Values not about Money. Brazil J Medicine Human Health 2016;4 (3). DOI: http://dx.doi.org/10.17267/2317-3386bjmhh.v4i3.1052
The results are summarized in three books.
Porzsolt F, Williams AR, Kaplan RM (eds): Klinische Ökonomik. Effektivität und Effizienz von Gesundheitsleistungen. Ecomed Verlagsgesellschaft 2003, pp 1-372
Porzsolt F, Kaplan RM (eds.) Optimizing Health – Improving the Value of Healthcare Delivery. Springer, New York, 2006, pp 1-313
Porzsolt F (Hrsg). Grundlagen der Klinischen Ökonomik. Schriftenreihe PVS Verband Band 11, 1.Auflage. Berlin 2011, pp 1-270