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Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement. The table shows the enrollment, interventions, and data collection protocols

From: Factors contributing to cognitive improvement effects of acupuncture in patients with mild cognitive impairment: a pilot randomized controlled trial

  Study period
Enrolment Allocation Post-allocation Close-out
Timepoint Screening Visit1–3 Visit4–6 Visit7–9 Visit10–12 Visit13–15 Visit16–18 Visit19–21 Visit22–24 Visit25
Week 1 2 3 4 5 6 7 8 20
 Informed consent X           
 Sociodemographic profile X           
 Medical history X           
 Vital signs X X X X X X X X X X X
  Inclusion/exclusion criteria X           
  Allocation   X          
  K-MMSE, MoCA-K X           
 Acupuncture treatment    X X X X X X X X  
 Change of medical history    X X X X X X X X X
 Safety assessment    X X X X X X X X X
  ADAS-K-cog    X        X X
  MoCA-K    X        X X
  CES-D    X        X X
  K-ADL, K-IADL    X        X X
  EQ-5D-5L    X        X X
  1. K-MMSE, Korean version of Mini-Mental State Examination; MoCA-K, Korean version of the Montreal Cognitive Assessment; ADAS-K-cog, Korean version of Alzheimer’s Disease Assessment Scale-cognitive subscale; CES-D, Center for Epidemiological Studies-Depression Scale; K-ADL, Korean Activities of Daily Living; K-IADL, Korean Instrumental Activities of Daily Living; EQ-5D-5L, European Quality of Life Five Dimension-Five Level Scale