“United Nations Educational, Scientific and Cultural Organization (UNESCO) defines research as systematic and creative actions taken to increase knowledge about humans, culture, and society and to apply it in new areas of interest. Scientific research is the research performed by applying systematic and constructed scientific methods to obtain, analyze, and interpret data.
“Scientific research is the neutral, systematic, planned, and multiple-step process that uses previously discovered facts to advance knowledge that does not exist in the literature. It can be classified as observational or experimental with respect to data collection techniques, descriptive or analytical with respect to causality, and prospective, retrospective, or cross-sectional with respect to time (1).
“All scientific investigations start with a specific research question and the formulation of a hypothesis to answer this question. Hypothesis should be clear, specific, and directly aim to answer the research question. A strong and testable hypothesis is the fundamental part of the scientific research. The next step is testing the hypothesis using scientific method to approve or disapprove it.
“Scientific method should be neutral, objective, rational, and as a result, should be able to approve or disapprove the hypothesis. The research plan should include the procedure to obtain data and evaluate the variables. It should ensure that analyzable data are obtained. It should also include plans on the statistical analysis to be performed. The number of subjects and controls needed to get valid statistical results should be calculated, and data should be obtained in appropriate numbers and methods. The researcher should be continuously observing and recording all data obtained.
“Data should be analyzed with the most appropriate statistical methods and be rearranged to make more sense if needed. Unfortunately, results obtained via analyses are not always sufficiently clear. Multiple reevaluations of data, review of the literature, and interpretation of results in light of previous research are required. Only after the completion of these stages can a research be written and presented to the scientific society. A well-conducted and precisely written research should always be open to scientific criticism. It should also be kept in mind that research should be in line with ethical rules all through its stages.
“Actually, psychiatric research has been developing rapidly, possibly even more than any other medical field, thus reflecting the utilization of new research methods and advanced treatment technologies. Nevertheless, basic research principles and ethical considerations keep their importance.
“Ethics are standards used to differentiate acceptable and unacceptable behavior. Adhering to ethical standards in scientific research is noteworthy because of many different reasons. First, these standards promote the aims of research, such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating, falsifying, or misrepresenting research data promote truth and minimize error. In addition, ethical standards promote values that are essential to collaborative work, such as trust, accountability, mutual respect, and fairness. Many ethical standards in research, such as guidelines for authorship, copyright and patenting policies, data-sharing policies, and confidentiality rules in peer review, are designed to protect intellectual property interests while encouraging collaboration. Many ethical standards such as policies on research misconduct and conflicts of interest are necessary to ensure that researchers can be held accountable to the public. Last but not the least, ethical standards of research promote a variety of other important moral and social values, such as social responsibility, human rights, animal welfare, compliance with the law, and public health and safety (2). In conclusion, for the good of science and humanity, research has the inevitable responsibility of precisely transferring the knowledge to new generations (3).
“In medical research, all clinical investigations are obliged to comply with some ethical principles. These principles could be summarized as respect to humans, respect to the society, benefit, harmlessness, autonomy, and justice. Respect to humans indicates that all humans have the right to refuse to participate in an investigation or to withdraw their consent any time without any repercussions. Respect to society indicates that clinical research should seek answers to scientific questions using scientific methods and should benefit the society. Benefit indicates that research outcomes are supposed to provide solutions to a health problem. Harmlessness describes all necessary precautions that are taken to protect volunteers from potential harm. Autonomy indicates that participating in research is voluntary and with freewill. Justice indicates that subject selection is based on justice and special care is taken for special groups that could be easily traumatized (4).
In psychiatric studies, if the patient is not capable of giving consent, the relatives have the right to consent on behalf of the patient. This is based on the idea of providing benefit to the patient with discovery of new treatment methods via research. However, the relatives’ consent rights are under debate from an ethical point of view. On the other hand, research on those patients aim to directly get new knowledge about them, and it looks like an inevitable necessity. The only precaution that could be taken to overcome this ambivalence has been the scrupulous audit of the Research Ethic Committees. Still, there are many examples that show that this method is not always able to prevent patient abuse (5). Therefore, it is difficult to claim autonomy when psychiatric patients are studied, and psychiatric patients are considered among patients to require special care.
Even the world authority on research claims “all clinical investigations are obliged to comply with some ethical principals.”
- As respect to Humans (can refuse or withdraw)
- As respect to Society (benefit society)
- Benefit (for solutions to health concern)
- Harmlessness (do no harm)
- Autonomy (voluntary and free will)
- Justice (fairness)
Though scientific research is unbiased and provable, there is strict concerns over harm, just, ethical, free will and trauma. Therefore, as a society we must be well versed in these terms as well. Merriam-Webster definitions:
- Harm – injury, and damage mean an act that causes loss or pain. harm can be used of anything that causes suffering or loss.
- Just – having a basis in or conforming to fact or reason, acting or being in conformity with what is morally upright or good.
- Ethical – dealing with what is good and bad and with moral duty and obligation, moral approval or disapproval, conforming to accepted standards of conduct
- Free Will – voluntary choice or decision, freedom of humans to make choices that are not determined by prior causes or by divine intervention
- Traumatic – relating to, being, or caused by a sudden, severe, often life-threatening injury, psychologically or emotionally stressful in a way that can lead to serious mental and emotional problems, an injury caused by an extrinsic agent (something outside)
NATIONAL INSTITUTE OF HEALTH (1887)
“The National Institutes of Health is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late 1870s, and is now part of the United States Department of Health and Human Services.” Wikipedia
MISSION: “NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.”
‘In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research:
- in the causes, diagnosis, prevention, and cure of human diseases;
- in the processes of human growth and development;
- in the biological effects of environmental contaminants;
- in the understanding of mental, addictive and physical disorders; and
- in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists.
NATIONAL SCIENCE FOUNDATION (1944)
“1944 – November 17: President Franklin D. Roosevelt writes Vannevar Bush, Director of the Office of Scientific Research and Development, asking how the successful application of scientific knowledge to wartime problems could be carried over into peacetime.” (President Roosevelt’s Letter)
EVIDENCE BASED SCIENCE (1991)
“Clinical practice was historically viewed as the “art of medicine.” Expert opinion, experience, and authoritarian judgment were the foundation for decision making. The use of scientific methodology, as in biomedical research, and statistical analysis, as in epidemiology, were rare in the world of medicine. Historical precedence and indoctrinated political mistrust of these other disciplines posed barriers to incorporating these tools into medicine.”
“Although EBM is now formally taught in many centres of higher education, such as the renowned McMasters Workshop, the Oxford University workshop, the University of North Carolina, and Duke University, there has been substantial criticism of its inherent weaknesses. Critics claim that EBM lacks utility on several levels. Some claim that it transforms the complex process of clinical decision making—which includes data gathering, years of medical knowledge, experience, and astute intuition—into an algorithmic exercise that is not individualized for specific clinical scenarios and therefore subject to error in patient care. Even Alvan Feinstein himself critiqued the work of McMasters University. The argument that EBM incorporates the “the best available external clinical evidence from systematic search” requires an understanding of what constitutes “best…evidence.” For questions about treatment, the RCT and systematic review/meta-analysis are the “gold standard” for EBM, over non-experimental approaches. And yet Feinstein highlighted that both insulin for diabetic acidosis and penicillin for bacterial endocarditis were introduced through single study articles and therefore would never have been included in the work of the Cochrane Collaboration. He argued EBM proponents have an over-reliance on the RCT [ randomized control trial]. RCTs are simply a comparison of one treatment to another treatment, not some superior form of truth. In relying on these epidemiological tools, EBM does not incorporate the “soft” data that clinicians use to formulate diagnoses and treatments. These “soft” data include type and severity of symptoms, and rate of growth of illness. Additionally, social and political contexts within which patients live are equally not addressed in EBM Lastly, critiques of EBM cite the potential for abuse of the label “best available evidence.” Health care policy makers and both government and private payers can coerce and justify reimbursement based on the “best available evidence” and marginalize practice that does not conform to these standards.
“Notwithstanding these potential deficiencies, EBM has made a clear and probable permanent mark on the face of medicine. The introduction of clinical epidemiology into the daily practice of clinicians has offered a systematized, scientific approach to the practice of medicine.
JAMA. 1992 Nov 4;268(17):2420-5. Evidence-based medicine. A new approach to teaching the practice of medicine.
“Evidence-based medicine de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research.”
November 4, 1992 Evidence-Based MedicineA New Approach to Teaching the Practice of Medicine
The concern is a “standard of care” that no longer relates or understands the patient in a patient centric way and the unique considerations to everything that make them unique.
EVIDENCE BASED RESEARCH does not consider knowledge, experience and intuitions or what they consider “soft”:
- Type of symptoms
- Severity of symptoms
- Rate of growth of symptoms
- Social Context
- Political Context
The decisions of the EBM is based on hard data of a “standard”. This does not include all the information that is personal to the patient. The choice over one or the other is not based on a superior truth, just a “randomized control trial”. Thus, when a family or individual crisis is based on a very specific set of circumstances and is personal to the individual or familial group, a standard practice will not necessarily benefit the person or group given their unique experience(s) and response(s). Human dynamics are complex. Their dynamics are complex. Their experience is complex. Thus, recovery will be complex.
The focus can not be on LONG TERM INTERVENTIONS. The focus needs to shift to an empowerment of the individual and family within the community. The biggest challenge will be the shift in public professional opinion. The families will readily get involved once they realize the design is to help them do what they want to do. This will not be achieved through a one sized standard of care that is mandated from the government or a specialist. The recovery has to be based on the the person, their experience and what works to empower them again. Not a behavioral evaluation, but a self evaluation of their best experience of self.
EVIDENCE BASED MEDICINE (1996)
BMJ. 1996 Jan 13;312(7023):71-2. Evidence based medicine: what it is and what it isn’t.
Medicine needs both research and expertise. Without both, they can become tyrannized or out of date, thus potentially harmful. Both can be a detriment to someone seeking help. The idea that Evidence Based Medicine is not a “cookbook” guide to medicine. A bottom up approach is much more appropriate. Persons choice, professionals expertise and best practices.
EVIDENCE BASED MEDICINE (1997)
Am J Med. 1997 Dec;103(6):529-35. Problems in the “evidence” of “evidence-based medicine”.
“The proposed practice of “evidence-based medicine,” which calls for careful clinical judgment in evaluating the “best available evidence,” should be differentiated from the special collection of data regarded as suitable evidence. Although the proposed practice does not seem new, the new collection of “best available” information has major constraints for the care of individual patients. Derived almost exclusively from randomized trials and meta-analyses, the data do not include many types of treatments or patients seen in clinical practice; and the results show comparative efficacy of treatment for an “average” randomized patient, not for pertinent subgroups formed by such cogent clinical features as severity of symptoms, illness, co-morbidity, and other clinical nuances. The intention-to-treat analyses do not reflect important post-randomization events leading to altered treatment; and the results seldom provide suitable background data when therapy is given prophylactically rather than remedially, or when therapeutic advantages are equivocal. Randomized trial information is also seldom available for issues in etiology, diagnosis, and prognosis, and for clinical decisions that depend on pathophysiologic changes, psychosocial factors and support, personal preferences of patients, and strategies for giving comfort and reassurance. The laudable goal of making clinical decisions based on evidence can be impaired by the restricted quality and scope of what is collected as “best available evidence.” The authoritative aura given to the collection, however, may lead to major abuses that produce inappropriate guidelines or doctrinaire dogmas for clinical practice.”
Evidence Based Medicine is for an “average randomized patient” from randomized trials and a mega data analysis. History, circumstance, experience, personal dna, preferences, feelings, etiology (causation), diagnosis, prognosis, pathophysiologic changes, psychosocial factors, support and strategies for comfort and reassurance.
These are all the reason, family are not able to move forward after crisis. Leaving out the data that is specific to the individual and their circumstance is a formula for failure. Crisis recovery and personal empowerment is related to the unique individual.