Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID.

OBJECTIVE: The reporting of patient-reported outcomes (PRO) instrument development is vital for both researchers and clinicians to determine its validity, thus, we propose the Preferred Reporting Items for PRO Instrument Development (PRIPROID) to improve the quality of reports. METHODS: Abiding by the guidance published by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, we had performed 6 steps for items development: identified the need for a guideline, performed a literature review, obtained funding for the guideline initiative, identified participants, conducted a Delphi exercise and generated a list of PRIPROID items for consideration at the face-to-face meeting. RESULTS: Twenty three items subheadings under 7 topics were included: title and structured abstract, rationale, objectives, intention, eligibility criteria, conceptual framework, items generation, response options, scoring, times, administrative modes, burden assessment, properties assessment, statistical methods, participants, main results, and additional analysis, summary of evidence, limitations, clinical attentions, and conclusions, item pools or final form, and funding. CONCLUSIONS: The PRIPROID contains many elements of the PRO research, and this assists researchers to report their results more accurately and to a certain degree use this instrument to evaluate the quality of the research methods.

[On the necessity of developing quality of life instruments in traditional Chinese medicine].

The development of health-related quality of life (HRQL) instrument in traditional Chinese medicine (TCM) is increasing rapidly in China, but few studies focus on their necessity. This study explores the necessity of the development of TCM instruments from both theoretical and practice perspectives, and aims to explain whether the adoption of the cross-medical style is valid. Through theoretical analysis, both TCM and Western medicine instruments show the same objectives, whereas TCM instruments are more suitable for the Chinese social behavior, customs and expectations. In practical analysis, 47 TCM instruments were identified, among which 17 had 18 corresponding Western medical instruments. In the domains layer, except for physiological, psychological and social factors, TCM instruments focus more on the harmony between body and spirit, humanity and nature or human and society and the constitution, etc. In the facts layer, TCM instruments focus on the emotions, initiative social intercourse, TCM symptoms, diet, sleep, taste, feces and urine, etc. In addition, significant differences existed in the methods of information selection. There is no need to modify cross-medical style research except when TCM characteristic terms exist, but attention must be paid to the influence of culture in different areas. Therefore, the TCM instruments can resolve the limitations of the application of Western medical instruments to the Chinese setting, while also having remarkable abilities of information coverage and detection. Both forms of instruments have the capacity and requirement to inter-communicate with each other in order to serve the whole Chinese cultural system. Generally speaking, there is no need to modify the instruments in cross-medical style research. But this point requires further demonstration in the rigorous designed clinical trials.