Study On Conceptual Framework Of Clinician-Reported Outcomes (CROs) In Traditional Chinese Medicine (TCM)

BackgroundClinician-reported outcomes (CROs) are one of outcomes from the angle of reporters. At present, most of the CROs studies in the west are mainly based on physiological outcomes combined with the explanation from the clinicians. Through reviews on the Chinese medical classics, we found that CROs, as a common mode of treatment evaluation, existed imperceptibly in the process of healthcare service. However, CROs in Traditional Chinese Medicine (TCM) remain at the experience level, and a thorough, in-depth and systematic research is rarely seen.Prof. Ron D. Hays, the specialist in the methodology of patient-reported outcomes (PROs), said that "CROs is not as widely thought about in the west because PROs are a backlash to the doctor being seen as the all knowing expert." In the past, providers may neglect symptoms even when their importance to patients is clear, but the changes of symptoms play quite important roles in outcomes assessments, especially for the TCM clinicians. Both CROs and PROs in TCM are the perspective of patients’ health status, and the patients’ concerns might have an overlap with what clinicians care about, so it appears that the experience of PRO research in western medicine maybe used to guide evaluation methods for CROs in TCM.In the light of the early results, we put forward the working hypothesis that CROs follow closely TCM pathogenesis and focus on the harmony of treatment and pathogenesis, and clinicians capture the changing signs of pathogenesis to judge the prognosis and guide the decision."TCM pathogenesis" is the abstraction and description of body functions from the clinician’s viewpoint in the occurrence and development of diseases. The key point of this study is to define the concept of CROs in TCM, classify concepts hierarchically, translate abstract concepts into specific indications and construct a conceptual framework of CROs, which provides the foundation for later studies. SignificancePattern differentiation and individual treatment are the characteristics of TCM. Clinicians do not always follow the same prescription, but make adjustments continuously according to the pathological pattern differentiation from the beginning to the current status. It is a creative work to measure CROs in TCM based on the TCM characteristics and modern methodology. The first step in this process involves the articulation of a conceptual framework of subjective clinician-reported outcomes.ObjectiveWe aimed to develop a conceptual framework of CROs in TCM to support measurement clarity.MethodsTo develop the conceptual framework, we combined top-down and bottom up approaches. As to top down approach, the principles of sequence are from the abstract to the concrete. It is to be the first to define concept, the next to identify domains and last to analyze indications. Literature review is the main method in this study. Bottom up approach is contrary to that mentioned above, it is from the concrete to the abstract. Clinical observation is used in this study.ResultsThe conceptual framework of CROs in TCM is a structured representation of outcome concepts, domains and indications. Specifically, it is a diagram of the expected relationships between specific outcome issues and the overall concepts.The concept of CROs:CROs are any report coming from clinicians about a health condition and its treatment, reflecting the effect of the treatment on the human body observed by clinicians, including efficacy, safety and satisfaction. The content of "efficacy" is the therapeutic effect, which includes not only clinicians’ observation and interpretation, but also measures used to elicit clinicians’ inputs. The content of "safety" is the possible adverse consequences, such as adverse reaction (AR), adverse events (AE) and severe adverse events (SAE). Satisfaction is a psychology status of clinicians who usually make treatment decisions from the comparison of the actual effect and the expected effect.The definition of CROs in TCM:CROs in TCM are any report coming from clinicians about a health condition and its treatment from the last visit to the current visit of the patient. The domains of CROs in TCM:"Efficacy" of CROs in TCM is a clinician’s perspective on his patient’s health status based on the changing signs of pathogenesis. It is the main point of CROs in TCM. The changing signs of pathogenesis adjusted by a clinician are chiefly manifested in the disharmony of "body" and "mind". The disharmony of "body" is closely related to the eight kinds of therapy in TCM. It shows in the following respects:diaphoresis, wastes and toxins, urine, feces, appetite, temperature of four limbs, symptoms related to mouth, blood stasis/worm/secretion, strength/energy, some skin diseases and ulcers. The following concerns reflect the disharmony of "mind":spirits, consciousness, thought, sensibility, response, figure, movement, complexion, eye expression, respiration, speech, tongue picture and pulse manifestation."Safety" of CROs in TCM is adverse consequences influenced by the herbal decoction, such as AR, AE and SAE. The following issues not based on pattern differentiation are outlined:compatibility, processing, decoction preparation, dosage and period of treatment, misuse, quality, the bogus or substandard, combined administration and patient’s constitution. And besides, there are some complications caused by inappropriate pattern differentiation and mistreatment."Satisfaction" of CROs in TCM is a clinician’s attitude to the last treatment which has an effect on the next clinical decision. The clinician usually does not change prescriptions with good satisfactory therapeutic effect. However, if the effects are not visible, the clinician might follow his former result of pattern differentiation to make out a prescription based on the original formula, or represent a new way of thinking to deal with another prescription.ConclusionPROs are any report coming from patients about a health condition and its treatment. The main point is the Health-Related Quality of Life (HRQL). Both of the PROs in TCM and in western medicine are the experience and sufferings of the patients.CROs are any report coming from clinicians about a patient’s health condition and its treatment, including efficacy, safety and satisfaction. CROs in western medicine are mainly based on physiological outcomes combined with the explanation from the clinicians, which focus on the relationship of morphological structure and body functions. CROs in TCM lay particular emphasis on the changing signs of pathogenesis from the clinician’s viewpoint, which reflect the individual treatment based on pattern differentiation.This form of CROs grasps the essence of pattern differentiation and can be used as an intermediate and dynamic assessment of effect during the treatment. In order to accurately assess the treatment effect, we should use a comprehensive evaluation model by combination of CROs in TCM with PROs, laboratory tests and device measurements.The conceptual framework is referred to as generic because it assesses health concepts that represent basic clinician’s values and are relevant to every patient’s health status.