title: Developing clinical practice guidelines for Chinese herbal treatment of polycystic ovary syndrome: A mixed-methods modified Delphi study.
abstract: OBJECTIVE
  Preliminary evidence suggests Chinese herbal medicine (CHM) could be a viable treatment option for polycystic ovary syndrome (PCOS). Prior to conducting a clinical trial it is important to consider the characteristics of good clinical practice. This study aims to use professional consensus to establish good clinical practice guidelines for the CHM treatment of PCOS.
  
  
  METHODS
  CHM practitioners participated in a mixed-methods modified Delphi study involving three rounds of structured group communication. Round 1 involved qualitative interviews with practitioners to generate statements regarding good clinical practice. In round 2, these statements were distributed online to the same practitioners to rate their agreement using a 7-point Likert scale, where group consensus was defined as a median rating of ≥5. Statements reaching consensus were accepted for consideration onto the guideline whilst those not reaching consensus were re-distributed for consideration in round 3. Statements presented in the guidelines were graded from A (strong consensus) to D (no consensus) determined by median score and interquartile range.
  
  
  RESULTS
  11 CHM practitioners in the UK were recruited. After three Delphi rounds, 91 statement items in total had been considered, of which 89 (97.8%) reached consensus and 2 (2.2%) did not. The concluding set of guidelines consists of 85 items representing key features of CHM prescribing for PCOS.
  
  
  CONCLUSIONS
  These guidelines can be viewed as an initial framework that captures fundamental principles of good clinical practice for CHM.
authors.affiliation: University of Southampton, Primary Care and Population Sciences, Aldermoor Health Centre, Aldermoor Close, Southampton, Hampshire SO16 5ST, United Kingdom. Electronic address: L.Y.W.Lai@southampton.ac.uk.
authors.forename: Lily
authors.initials: L
authors.lastname: Lai
authors.affiliation: University of Southampton, Primary Care and Population Sciences, Aldermoor Health Centre, Aldermoor Close, Southampton, Hampshire SO16 5ST, United Kingdom. Electronic address: flower.power@which.net.
authors.forename: Andrew
authors.initials: A
authors.lastname: Flower
authors.affiliation: University of Southampton, Primary Care and Population Sciences, Aldermoor Health Centre, Aldermoor Close, Southampton, Hampshire SO16 5ST, United Kingdom. Electronic address: mvm198@southampton.ac.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: Moore
authors.affiliation: University of Southampton, Primary Care and Population Sciences, Aldermoor Health Centre, Aldermoor Close, Southampton, Hampshire SO16 5ST, United Kingdom. Electronic address: GL3@southampton.ac.uk.
authors.forename: George
authors.initials: G
authors.lastname: Lewith
mesh_terms: D003697:Delphi Technique; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006282:Health Personnel / Q000193:education; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D011085:Polycystic Ovary Syndrome / Q000188:drug therapy*; D017410:Practice Guidelines as Topic
chemical_list: D004365:Drugs, Chinese Herbal
keywords: Chinese herbal medicine; Delphi; Menstrual disorders; Mixed methods; Polycystic ovary syndrome