In the medical community, there is a strong consensus that external evidence on “efficacy and safety of therapeutic, rehabilitative, and preventive regimens” should be the basis of decision-making in clinical practice.1 The same principle should also be used when choosing diagnostic tests, laboratory analysis, and imaging techniques.
The Informed Medical Decisions Foundation defines shared decision-making as “a collaborative process that allows patients or their surrogates, and clinicians to make health care decisions together, taking into account the best scientific evidence available, as well as the patient’s values, and preferences.”2
However, Sackett1 also pointed out that the clinical judgment, based on training and experience of the physician, plays an important role in the decision-making process with regard to the individual treatment plan. Last but not the least, he stressed that the patients’ individual values and preferences must be taken into account for choosing the best procedures for the individual case.1 These three factors are often visualized in a three-circle graph showing the three factors and their overlap (Fig. 1).3 Recently, patients’ goals are also included, in addition to values and preferences.2
Building off of the Sackett’s model, a more complex framework was published in 1998.4 In this publication, the authors highlighted that contextual factors significantly influence the implementation of evidence-based practice at the individual level. The identified three main factors include culture, leadership, and measurement. The authors integrated these factors in a three-axis model together with evidence and facilitators. Another more complex model is provided by Lomas5 (1994). The latter model stressed the relevance of the economic and community environment together with the administrative environment and personal. These are influenced by external factors such as economic recession, media, availability of new information, and perception by society.
DECISION-MAKING IN REHABILITATION
Despite the development of more complex models, the current literature fails to account for the complexity of factors, including personal and environmental ones that influence both the individuals’ state of functioning and the outcomes of rehabilitation interventions. Environmental and personal factors are part of domains of International Classification of Functioning, Disability and Health (ICF) (Fig. 2).6 Within the ICF framework, functioning is defined as an interaction of a person with a health condition and the material and social environment. This concept has been proven in numerous studies.7–9 It also has been shown that environmental factors influence decision-making for setting up an individual treatment plan.
From theoretical models and clinical practice model of decision-making in rehabilitation, it is clear that health system and service organization also influence the decision-making. This factor not only includes the availability of treatment, quality of treatments, and financing but also facilities, which include technical equipment and human resources. The structure of the health systems including the availability of health insurances or national health systems, the spectrum of coverage of interventions, and the rules for the registration of medicines can clearly influence the clinical decision-making process. It also should include the importance of access to assistive devices or social compensation payment for successful rehabilitation outcomes.10,11
More in detail, some of these factors may be described as follows (lists not exhaustive):
- At the meso level of the health care system and services relevant factors concern both the availability of services and health work force. This includes:
- ○ Coverage and affordability of medicines, treatments, and other health goods within the health system (or health insurances, respectively)
- Example: if a health insurance only covers essential medicines to treat severe diseases, the patient will not receive additional treatment. Although evidences have shown that the additional treatment can improve well-being and quality of life.
- ○ Availability and quality of medicines, treatments, and other health goods on the national or local market.
- Example: if an innovative drug has been developed to treat a certain infectious disease (eg, new antibiotic or antiviral drug) and it is not available in a country, the patient will not receive it.
- ○ Rules and quality of training of physician, therapists, pharmacists, and other health professionals.
- Example: If there are specific rules for additional qualification to prescribe certain intervention (eg, prescription of rehabilitation interventions) or diagnostic procedure (eg, ultrasound imaging), and the physician does not have this qualification, the patient may not receive this treatment or diagnostic procedure.
- ○ Availability and capacity as well as access to health professionals
- Example: if a specific group of health professionals (eg, psychotherapists, occupational therapist) are not available in a country or region or do not have enough capacity, the patient might not receive this intervention even he or she is in need
- At the macro level of the health system, these factors are (for example):
- ○ “Philosophy” or principles of treatment goals in national health systems (eg, full-service vs. minimal services philosophy).
- Example: If in a health system to secure survival and to treat severe diseases is the only scope of a health system, patients may not receive interventions aiming at mobility or work capacity.
- ○ (legal or administrative) rules and procedures for registration of medicines, treatments and other health goods.
- Example: If a country does not have very extensive administrative rules for the registration of a new treatment even its efficacy has been proven elsewhere, in the early stage patients might not receive this treatment.
- ○ Availability of certain interventions in a country or region
- Example: if in a country postacute rehabilitation services do not exist, the patients will not get any postacute rehabilitation.
- ○ Access and prescription rules for medicines, treatments and other health goods (eg, type of prescription, distribution via special sellers [eg, pharmacies], direct access to therapists)
- Example: If physiotherapy need prescription by a physician and he or she does not make the prescription (eg, because auf budget limitations), the patient might not get this treatment even if he or she is in need.
- ○ Information systems for physicians, therapists, pharmacists, and other relevant players in the process as well as for the patients
- Example: if a physician and the patient are not informed about a newly discovered side effect or risk of a specific drug, the physician might continue prescribing it even though it is risky for the individual patient.
The given list of examples shows the relevance and influence of the health system and service organization for the decision-making in an individual case.
In the ICF,6 most of these factors are classified in the chapter “Environmental Factors” (Table 1). The factors at meso level additionally can be classified using the International Classification of Service Organization in Rehabilitation.12,13
Based on these considerations, it is proposed to add a fourth factor to David L Sackett’s model of evidence-based practice (Fig. 3), which can be summarized as a factor of “Health System and Service Organization.” As described previously, this includes health policies, funding, availability and quality of diagnostic tools, and interventions.
For rehabilitation medicine, aspects of health system and service organization are of major relevance in individual decision-making at micro level (the individual rehabilitation plan). They consist of both the meso (rehabilitation services and workforce) and macro level (health and social systems) components. Physical and rehabilitation medicine specialists have knowledge about the importance of the health system and service organization and are trained to integrate its component into individual decision-making. Even if the influence of health systems and service organization is less important in other medical fields, the authors are convinced that it influences decision-making process. To make the reason of decision-making process more transparent, health system components such as compensation payment by insurances and availability of interventions are important to be documented and reported. This will allow the patient to set more realistic expectations and understand limitations and outcomes given the multifactor contribution. It may also facilitate the implementation of guidelines, ie, if they require behavioral changes in patients (which is the case in most chronic health conditions). In the end, it might also influence users’ acceptance.
The examples of the relevance of availability of rehabilitation interventions have been highlighted in many documents and scientific papers. For example, the lack of rehabilitation services at country level and its consequences have been studied among others by Shirazikhah et al.14–16 (see also Gutenbrunner and Nugraha17–19). Nonavailability and/or lack of specialized rehabilitation services have been shown in different countries.20–22 In many countries, ie, in low and lower middle-income countries, the availability of affordable assistive devices is far below the needs of persons with disabilities.23 This is also the case for other rehabilitation interventions and the access to rehabilitation professionals, for example, the nonexistence and/or lack of occupational therapists and/or physical and rehabilitation medicine specialists in many countries in the world.17,19,24 These examples show that health systems factors, ie, the availability of services and interventions have a strong influence on decision-making in rehabilitation and the services and individual’s acceptance.
As previously mentioned, understanding the health system and service organization will promote the setting of more realistic expectations and the understanding of outcomes given the multifactor contributions. Furthermore, this evidence-based practice, which is based on the four factors, also fits with the framework of health system response and individual’s need (Fig. 4).25
As health systems and service organization influence decision-making in interaction of health professional and patients/health care users, it is proposed to integrate this as a fourth factor into the Sackett’s model of evidence-based clinical decision-making. The authors are aware that such a proposal will require a more in-depth expert discussion. The relevance of single component needs to be elucidated more by using appropriate scientific methodology. However, the authors are convinced that health system and service organization are relevant and influential factors for evidence-based clinical decision-making process. It will increase transparency and acceptance by the users and improve outcomes. In any case, physicians and therapists should be informed about relevant component of health system and service organization that are relevant and influencing their daily practice.
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