Initiative evidence-based establishment of an indicator pool for clinical evaluation of nutritional and functional food for the elderly with sarcopenia
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(Department of Clinical Nutrition,West China Hospital,Sichuan University,Chengdu 610041, China)

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    Abstract:

    Objective To establish an indicator pool for clinical trials on nutritional and functional food interventions for the elderly with sarcopenia as the basis of subsequent core outcome set. Methods CNKI, VIP, WANFANG DATA, Ovid-Embase, Cochrane Library and PubMed databases were electronically searched to collect randomized control trials on nutritional and functional food interventions for the elderly with sarcopenia. The outcome indicators were extracted as set A. Chi-CTR and the Clinical Trials were then searched to collect the related registration schemes, and the outcome indicators were extracted to form set B. Using the convenience sampling, a semi-open questionnaire survey was conducted among the clinicians and patients in 17 first-class tertiary hospitals with great influence in this field to collect the set (C) of outcome indicators concerned by the doctors and the set (D) of outcome indicators concerned by the patient. A 5-dimension indicators pool of 64 end-class indicators was initially constructed by integrating the sets A, B, C and D. Results A total of 16 randomized control studies and 15 clinical trial protocols were included, yielding 95 outcomes in set A and 86 in set B. A total of 86 doctors and 85 patients′ opinions were investigated, and 38 and 35 outcome indicators were collected in set C and set D. According to inclusion and exclusion standard of indicators, a final pool of 64 terminal indicators was established. Conclusion This study established an indicator pool for the elderly patients with sarcopenia and found heterogeneity and inconsistencies in the outcome indicators of clinical trials in this field. It is of great significance to continue constructing the core outcome set on nutritional and functional food interventions for those patients.

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History
  • Received:January 18,2021
  • Revised:
  • Adopted:
  • Online: November 02,2021
  • Published: