Evidenced based falsification of data or validation of the individual patient in front of us?

Often, we hear: “We only use evidenced based research in our clinical work” – or? Is this really correct or misunderstanding the difference between scientific and clinical focus?

If we think a little deeper, what does it indicated?
If we plan and carry out normative (nomothetic) studies we focus on falsification (see http://biopsychosocialmedicine.com/paradigm/) of data of reductionistic hypothesis far from an individual´s real biopsychosocial-cultural world and the falsified interpretation of the obtained data does not have much if anything to said about the patient in front of me. We certainly do not what to falsify the patient but find out a individual specific hypothesis diagnosis for temporary validation of the particular patient – or? A diagnosis hypothesis to be carefully followed and adjusted over time, that is, what it specially concerns complex life-style related diseases and problems.

Of course, in clinical work we have the responsibility to focus on the individual patient and her/his problems/symptoms/… especially (again) life style and stress related dysfunctions associated with individuals particular way of every day living in a complex real world of which we have still very limited knowledge about. In opposites; as scientists” we try to control for one or few variables and use Fisher (usually) statistics to get significances which have no or almost no significance for the patient in front of us. But, we learn that we should work according to evidence based criteria – or? Evidenced based empirical research of what? Of course, some of us try to find a middle way with “evidenced based practice”, which may lead to development of ideographic a priori predicted repeated measurement single case methodology enabled to be “moved” towards normative levels emphasizing sub, subsub, subsbsub … within levels using the AI-toolboxes to get some guidelines have to help the suffering patient in front of me.

Some more on the notion of Evidenced Based Practice paradigms https://en.wikipedia.org/wiki/Evidence-based_practice, then? “The goal of evidence-based practice is to eliminate unsound or outdated practices in favor of more-effective ones by shifting the basis for decision making from tradition, intuition, and unsystematic experience to firmly grounded scientific research” (link above).

Is the above enough for welcoming patients into the scientific work?

We are a growing number of clinicians who want (a) validate individuals before (b) falsify (reductionistic) data/approaches including pharmacological substances. Bringing the patient in front of me back to best possible health is my goal.

One thing more to be considered from “scientific language” is what is the difference between  dependent and independent variables, e.g. “We regard the respiration behavior of our patients as a key and a tool for a better understanding. It provides a practical clinical measure for the diagnosis and training both
on-line and over time. Respiration is both the independent and dependent variable (Ley,
1994) depending on where you are positioned—and so is the patient (Kelly, 1955)” from https://www.semanticscholar.org/paper/The-measurement-of-respiratory-and-metabolic-of-and-Sch%C3%A9ele-Sch%C3%A9ele/188e53f53d6df56f3d6ad1b64c8aacb730248220. Or differences between induction, deduction and abduction. Also – the problem of excluding REAL placebo effects (when appropriate and possible) can e.g. the reversed example serve when a pharmacological company in their study for did a study to identify spontaneous placebo-reacting subjects from not such, Then they carefully placed the placebo-reacting subjects in the treatment group and the not-responders in the control. Bingo before it was discovered.

A way to do seriously is to identify first not placebo responders and then randomize out of this group!


Single-subject designs as a tool for evidence-based clinical practice: Are they unrecognized and undervalued? “One could be forgiven for thinking that the only road to evidence-based clinical practice is the application of results from randomized controlled trials (or systematic reviews of such). By contrast, single-subject designs in the context of evidence-based clinical practice are believed by many to be strange bedfellows. In this paper, we argue that single-subject designs play an important role in evidence-based clinical practice. We survey the contents of Neuropsychological Rehabilitation in relation to single-subject designs and tackle the main criticisms that have been levelled against them. We offer practical guidance for rating the methodological quality of single-subject designs and applying statistical techniques to measure treatment efficacy”. https://www.researchgate.net/publication/15980584_Single_Case_Experimental_Design_and_Empirical_Clinical_Practice

Actually, the above is very simple, if we simplify! To understand more about a single person we need to use single case design, mostly referring to Kazdin  https://www.researchgate.net/publication/254359681_Kazdin_A_E_2011_Single-Case_Research_Designs_Second_Edition but also quite difficult, apparently, to accomplish? If we see what is the normal behaviors in clinical work.

Example on more, perhaps forgotten work?
Single-case Experimental Designs: Strategies for Studying Behavioral Change David H. Barlow, PhD; Michel Hersen, PhD, “The difficulty of developing and evaluating effective treatments in psychiatry and clinical psychology points out the inadequacy of current research methodology involving comparisons of large groups. An alternative approach firmly founded in the scientific method, but particularly appropriate to the study of complex behavior disorders, is the single-case experimental design. In this paper, examples of different single-case designs actually employed in applied clinical research are presented and discussed. Practical problems arising during the course of research are highlighted and some basic procedures outlined. General questions on variability, representativeness of findings, and clinical versus statistical significance are briefly discussed”. https://jamanetwork.com/journals/jamapsychiatry/article-abstract/490969

My way concerning clinical methodology during 40 years has been IBED, Individual Biological Evidenced based Documentation within the manual “patient as a reasonable competent by us educated recourse and coworker”, where intake assessment are used for a priori prediction which is carefully followed up in DATA! Explaining and discussing together with patients’ findings ways ahead, where patient not only grow while being respectfully attended and listened to but also increasing motivated to do their job. Patients motivation problems during the years where excellent except what I remember now – one case. Also, one other main indication; Many patients seems (according to answers in questionnaires during two different working periods) continued their behavioral changes, which was one main reason for the education – “learning while doing while learning”.

If you say; “No evidenced based”, I say “Yes, the best available toolbox and design (so far), but far better than existing options. If you say; “If you use a toolbox, you do not know what worked or no”, I say; “Of course not, we never do also with a single, or few traditional evidenced based intervention, but ask the patients, they know more than present reductionistic science – or”?

Today we have more practical ideas of how to use single case designs within clinical psychophysiology – or? Including also “How to move from collecting ideographic data in clinical settings in a user friendly way within the every day clinical context to nomothetic levels giving both levels perspectives” in an all winner way – science and clinical real world!

Bo von Schéele, professor