Developing clinical practice guidelines for the treatment of polycystic ovary syndrome with Chinese herbal medicine: a mixed-method modified Delphi study

摘要

Background: polycystic ovary syndrome (PCOS) is the most common female reproductive endocrine disorder, affecting 6–18% of women of reproductive age. Chinese herbal medicine (CHM) is gaining popularity in the UK and has been historically effective for symptoms of PCOS. However, it remains unclear what constitutes routine clinical practice in CHM in order to conduct further rigorous research.Aim: the aim of this study was to develop clinical practice guidelines for the treatment of PCOS using CHM.Method: following a modified Delphi method, CHM practitioners were purposively sampled and interviewed to explore their views on CHM prescribing for PCOS. Interviews were transcribed verbatim and thematic and framework analysis was applied to transcriptions to formulate statements of key clinical practice points. These statements were distributed via an online questionnaire to the same herbalists who were invited to rate their agreement with each statement on a 7-point Likert scale. Group consensus on a statement was defined a priori as a median Likert score of 5 or more. Questionnaire statements not reaching consensus were re-distributed to herbalists for re-consideration via a further questionnaire.Results: eleven CHM practitioners based in the UK were recruited. Six themes emerged from interviews and 85 statements regarding clinical practice were produced. When these were distributed via a questionnaire, 83 reached group consensus (97.6%) with a response rate of 100%. In the subsequent questionnaire containing eight statements, six reached group consensus (75%) with a response rate of 100%. A total of 84 statements are presented in the concluding set of clinical practice guidelines, each one included following an assessment of relevance to clinical practice, which was independent of final group consensus rating. These statements were graded from A (strong consensus) to D (consensus not achieved), determined by considering the median and interquartile range of responses per statement.Conclusion: the Delphi method has been used successfully to facilitate a systematic and rigorous practitioner consultation exercise. This has resulted in the development of clinical practice guidelines that reflect routine CHM prescribing practices for PCOS. These guidelines will be used to inform the design of a forthcoming clinical study