Abstract

BackgroundShared decision-making (SDM) is a patient-centred approach in which clinicians and patients work side-by-side to decide together on the best course of action for each patient’s particular situation. Six key elements of SDM can be distinguished: situation diagnosis, choice awareness, option clarification, discussion of harms and benefits, deliberation of patient preferences and making the decision. Decision aids (DAs) are tools that facilitate SDM. The impact of DAs for chronic illnesses on SDM, clinical and patient reported outcomes remains uncertain.MethodsWe will perform a systematic review aiming to describe (a) which SDM elements are incorporated in DAs for adult patients with chronic conditions and (b) the effects of DA use on SDM, clinical and patient reported outcomes. This manuscript reports on the protocol for this systematic review. The following databases will be searched for relevant articles: PubMed, Embase, Web of Science, CINAHL and PsycINFO, from their inception to October 2016. We will ascertain ongoing research by querying experts and searching trial registries. To enhance feasibility, we will limit the review to randomized controlled trials (RCTs) including patients with chronic cardiovascular and/or respiratory diseases and/or diabetes. SDM elements incorporated in DAs, DA effects and DA itself will be described.DiscussionThis study will characterize DAs for chronic illness and will provide an overview of their effects on SDM, clinical and patient reported outcomes. We anticipate this review will bring to light knowledge gaps and inform further research into the design and use of DAs for patients with chronic conditions.Systematic review registrationPROSPERO registration number: CRD42016050320.

Highlights

  • Shared decision-making (SDM) is a patient-centred approach in which clinicians and patients work side-by-side to decide together on the best course of action for each patient’s particular situation

  • Decision aid (DA) can increase patient knowledge, reduce decisional conflict, help patients choose an option that is congruent with their values, reduce the proportion of patients remaining undecided and/or who play a passive role in the decision-making process and can have a positive effect on patient-clinician communication [12, 14,15,16,17]

  • This includes the SDM elements incorporated in DAs, the effects of DAs on SDM outcomes (i.e. decisional conflict, knowledge, patient participation in decision-making, treatment decision, treatment satisfaction, decision satisfaction, conversation satisfaction, risk expectations and perceptions, consultation time), clinical outcomes (i.e. lipid levels (LDL cholesterol, HDL cholesterol, total cholesterol, triglycerides), blood pressure, smoking status, oxygen uptake, glycaemic control, body mass index (BMI), adherence and achieving treatment goals) and patient reported outcomes (i.e. quality of life, perceived health status, emotional distress self-efficacy)

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Summary

Methods

Study design This protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols (PRISMA-P) (see “Additional file 1 PRISMA-P checklist.pdf” for the PRISMA-P checklist) [21]. After a pilot with 20 included full-texts, discrepancies will be discussed and instructions and/or criteria adapted if needed Disagreements and this phase will be resolved by consensus or arbitration by a third reviewer. Outcomes and data synthesis We will describe the RCTs included in our review, as well as the DAs that are tested in these studies This includes the SDM elements incorporated in DAs, the effects of DAs on SDM outcomes (i.e. decisional conflict, knowledge, patient participation in decision-making, treatment decision (preference), treatment satisfaction, decision satisfaction, conversation satisfaction, risk expectations and perceptions, consultation time), clinical outcomes (i.e. lipid levels (LDL cholesterol, HDL cholesterol, total cholesterol, triglycerides), blood pressure, smoking status, (maximal) oxygen uptake, glycaemic control, body mass index (BMI), adherence and achieving treatment goals) and patient reported outcomes (i.e. quality of life, perceived health status, emotional distress (anxiety, illness-related distress) self-efficacy).

Discussion
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