Developing and Evaluating a Patient Decision Aid for Managing Early Surgical Menopause

  • Author / Creator
    Siyam, Tasneem
  • Background: Early surgical menopause results in severe and prolonged health consequences due to early estrogen deprivation. Hormone therapy (HT) is a recommended treatment when no contraindications exist, yet it is poorly utilized by women with early surgical menopause. Given women perceived uncertainty about HT risks, a situation of complex decision-making ensues when deciding if HT is a suitable option. Other barriers to effective decision-making inherent in early surgical menopause are the abrupt presentation of severe menopausal symptoms, the long-term health sequelae and the need to make a decision on a short timeline. Patient decision aids (PDAs) are useful interventions when patients are faced with complex therapy decisions. No peer-reviewed, evidence-based PDAs currently exist to support women who go through early surgical menopause. Considering the complexity of decision-making about HT and the paucity of decision support strategies for early surgical menopause, we systematically developed and evaluated an evidence-based, self-administered PDA to help women make HT decisions for managing early surgical menopause. Methods: The PDA development was guided by the Ottawa decision support framework (ODSF) and the International Patient Decision Aid Standards (IPDAS) and involved: (1) assessing the need and feasibility of developing a PDA; (2) exploring the decision support needs of the target population; and (3) developing the PDA and evaluating for acceptability in a non-clinical setting. In phase one, a scoping review was completed to identify the nature and extent of research done in the area of decision aids for surgical menopause. A systematic review to assess the effect of HT in a sub-population of women who go through early surgical menopause was also completed to assess for feasibility of development. In phase two, the decisional needs of the target population were identified from five focus groups completed as part of a descriptive qualitative study to explore the process of decision-making about menopausal therapies in a sample of women who have had an early surgical menopause. As well, a narrative review to identify the decisional needs in a broader population of women with surgical menopause was conducted. In phase three, findings from phases one and two were used to inform the PDA development. The PDA was then evaluated in a cross-sectional mixed method study to elicit evidence on acceptability. To draft the PDA, relevant guidelines were targeted to gather information on surgical menopause, HT and evidence on risks and benefits. For outcome probabilities, systematic reviews addressing the risks and benefits of HT in surgical/natural menopause were searched. Data on HT outcome probabilities were evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). The development of the PDA was driven by a steering committee consisting of a multidisciplinary group of researchers, clinicians and patient partners to ensure women priorities were met. For the focus groups and the mixed method study, women were recruited from two menopause clinics in Edmonton, Alberta. The PDA was assessed against the IPDAS quality criteria for conformity with internationally recognized standards. Results: Informed by identified decisional needs and findings from the scoping and systematic reviews, a prototype of the SheEmpowers PDA was developed. The PDA focuses on five domains: information on surgical menopause and HT, outcomes and resources for menopausal support; HT outcome probabilities; patient stories; explicit values clarification; and guidance in deliberation. Clinician and patient experts from the steering committee provided positive feedback about the PDA and suggested improvements were implemented. Participants in the evaluation phase perceived the tool as acceptable and offered useful suggestions for targeted modifications. The tool met 39 of the 46 IPDAS quality criteria for content and development. Conclusion: Through our adopted, systematic, evidence-based and multidisciplinary approach the SheEmpowers PDA was developed that aims to help women overcome deterrents to decision-making related to lack of knowledge, decision-making skills and involvement in therapy decisions, for an ultimate goal of attaining informed and value-based decisions about HT, and a long-term goal of optimizing medication use among women of the target population. The effectiveness of the tool in terms of achieving those outcomes is yet to be assessed. The practice implications of such tools are of specific significance to health care professionals, particularly pharmacists, being the most accessible and trusted front-line healthcare professionals, as they support women in shared, informed and value-based decision-making for optimal medication use and health outcomes.

  • Subjects / Keywords
  • Graduation date
    Spring 2019
  • Type of Item
  • Degree
    Doctor of Philosophy
  • DOI
  • License
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