Shared decision making in pain care: a systematic review study protocol of decision aids

Abstract

Introduction

Shared decision making (SDM) in healthcare is an ethical imperative and essential to patient-centred care. SDM is particularly useful when several preference-sensitive treatment options exist and in the setting of chronic conditions or longitudinal management. Chronic pain management embodies these characteristics, yet SDM often remains insufficient in this population. Decision aids are designed to facilitate SDM by helping patients and clinicians understand treatment options, clarify patient values, and guide collaborative decision processes. Despite their importance, the use of decision aids in pain management is inconsistent and their reported effectiveness has been variable. However, the current landscape of decision aids for pain management has not been described. This lack of understanding of what tools exist, how they are structured, what decisions they address and how they were developed makes it difficult to advance implementation efforts or identify meaningful gaps in available resources. As such, the purpose of this systematic review is to identify and characterise decision aids for pain management across the lifespan. Specifically, this review will describe the clinical decisions addressed, decision aid structures and delivery formats, development processes and outcomes used to evaluate the impact of existing decision aids.

Methods and analysis

Electronic searches were performed in PubMed, CINAHL and Ovid Embase from inception through January 2026. Studies will be assessed for quality using the Mixed Methods Appraisal Tool. Data will be extracted and presented with the aim of describing the: (a) content and structures of pain-related decision aids, (b) development processes used to create existing pain-related decision aids and (c) outcome measures used to evaluate the impact of decision aids in clinical care.

Ethics and dissemination

This review does not require ethics approval. Findings will be disseminated to clinicians, researchers and patients through journal publications, conference presentations and in collaboration with patient partners.

PROSPERO registration number

CRD420251085288

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This is the first systematic review of decision aids for pain management across the lifespan.

• Findings will provide a comprehensive overview of the characteristics of current decision aids for pain management as well as the processes used to develop them and outcomes used to assess their impact.

• Due to limitations of language proficiency of authors, this review is restricted to papers published in English which can cause bias in our interpretation and limit generalisability to other language contexts.

• Given that our search is restricted to published data, unpublished decision aids or those in the early stages of development will not be included, which introduces publication bias.

• Given the definitions of pain used in the outlined study, other forms of pain (eg, postoperative, post-traumatic) would be grouped in either acute or chronic pain based on length of time (>3 months) rather than the unique features of those forms of pain.

Introduction

Chronic pain represents a significant global health burden, affecting millions.¹,³ Chronic pain causes impairments in physical function, diminished emotional well-being, decrements to overall quality of life,⁴,¹⁰ and is the leading cause of disability worldwide.¹¹ The multidimensional nature of chronic pain requires a comprehensive and interprofessional approach to management.¹² Multidisciplinary pain teams commonly comprise a range of healthcare professionals, including physicians (eg, anaesthesiologists), psychologists, nurses, nurse practitioners and rehabilitation specialists, including physical and occupational therapists.¹³ Despite the collaborative nature of these teams, patients often have limited opportunities to actively participate in discussions regarding their care and frequently report feeling invalidated, stigmatised and dismissed by their providers.¹⁴,¹⁶

Shared decision making (SDM) is a recommended health communication approach to increase patient engagement in treatment and outcomes.¹⁷,¹⁹ SDM emphasises a collaborative and patient-centred care model in which the knowledge and expertise of providers is integrated alongside the lived experience, values and family goals of patients to create an informed, evidence-based treatment plan.²⁰,²³ Increasing SDM in healthcare can provide numerous benefits, including improved decision-making outcomes (eg, increased decisional knowledge and self-efficacy, decreased decisional conflict and regret), improved patient-provider relationships and improvements in health-related outcomes (eg, improved health-related quality of life, reduction in healthcare use and unnecessary costs).²¹²⁴,²⁶ While most patients want to be involved in making decisions regarding their care,^{27 28} existing evidence indicates that SDM in healthcare is often insufficient,²⁹ including within chronic pain management.²⁵³⁰,³³ The gaps in SDM are even greater when addressing chronic pain management in children and youth.^{34 35}

Decision aids are the most common SDM tools.^{36 37} Decision aids help orient patients to the healthcare decision and their option to be involved, provide information and evidence on available treatment or management options, and support clarification and alignment of patient values and goals with available treatment options.³⁸ Decision aids have been developed in several healthcare populations, including for the management of pain and painful conditions (eg, cancer care, diabetes, osteoarthritis and orthopaedic surgery).³⁹,⁴² Decision aids may be particularly useful for chronic pain management where treatment is longitudinal in nature and often consists of several preference-sensitive treatment options, including self-management approaches. However, the current landscape of pain-related decision aids is unknown, which may contribute to documented variability in their effectiveness and uptake in clinical care. As such, this article outlines a protocol for a systematic review to identify and characterise decision aids for pain management across the lifespan. Specifically, this review will describe the clinical decisions addressed, decision aid structures and delivery formats, development processes and outcomes used to evaluate the impact of existing decision aids. The goal of this review is to identify existing pain-related decision aids that can be used in clinical care as well as gaps in current pain-related decision aids which can promote future research to improve SDM in chronic pain management.

Objectives

1. Identify and describe all published decision aids that address the management of pain for acute and chronic pain, including primary (eg, fibromyalgia) and secondary chronic pain conditions (eg, osteoarthritis).

2. Describe the processes and frameworks adopted by researchers in their development of decision aids for pain management.

3. Identify the outcomes used to assess the impact of developed decision aids for pain across three primary outcome domains: (a) decisional, (b) clinical and (c) implementation.

Methods/design

Protocol and registration

Methods for this review were developed using the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).⁴³ The protocol is registered on the international prospective register of systematic reviews (PROSPERO: CRD420251085288). The study planning and protocol development started in June 2025, the systematic search was conducted in January 2026 and data analysis and manuscript preparation are planned to end in January 2027. Only published studies and decision aids will be examined for this review. No ethical approval is required.

Patient and public involvement

Prior to forming the study protocol, the lead author met with patient partner panel embedded within the research laboratory. The patient advisory board developed in 2022, termed the BETTER panel (Bringing Everyone Together to Enhance Research), consists of 8 patient and 3 caregiver partners. During a quarterly panel meeting, the lead author gave a presentation on SDM and identified potential projects, including the outlined systematic review. Panel members were provided the opportunity to ask questions, propose changes to the method and were asked to comment on the relevance of the study to patient needs. Given endorsement from the panel, we continued in pursuing the project with integrated changes from the patient partners. We will continue to work alongside the BETTER panel in this project, presenting the decision aids to panel members for their review and feedback which will be integrated into our narrative synthesis. One of the panel members also elected to be part of the study team more directly. As such, the study’s purpose, methods and dissemination plans were further co-designed with one of the authors (AM), who is a young adult with chronic pain that onset in adolescence and who will continue to be a collaborator in the conduct of this review. She will be involved in guiding feedback from other patient partners on the panel and will provide feedback on data analysis with a focus on data important to communicate to patients and families. She will support the development of knowledge translation tools as indicated to communicate to the patient community the availability of decision aids that they can use in their clinical care. One additional team member and co-author (HS) joined the study team and has the lived experience of chronic pain. She will offer her insights as a person with lived experience and support the decision aid review process with the BETTER panel. No additional patients or the public are planned to be directly involved in the conduct of this study.

Eligibility criteria

We will include peer-reviewed studies that describe, develop or evaluate decision aids for the management of primary and secondary pain concerns for individuals across the lifespan. Eligible study designs include observational and comparator (randomised and non-randomised) studies as well as development (qualitative) and feasibility studies. Systematic reviews and meta-analyses will not be included but will be reviewed manually by study staff to identify any additional relevant references. In addition, if an included study references a previous publication associated with the same decision aid (eg, the development paper and additional trials), they will also be reviewed for inclusion. To be included, studies must report on at least one of the following: the content or structure of a pain-related decision aid, the development or design process for a pain-related decision aid, or the outcomes used to evaluate the impact, implementation (eg, feasibility) or effectiveness of a designed decision aid. We will exclude opinion papers, protocols and theoretical papers that overview decision-making frameworks and models without the development or implementation of an actual decision aid.

Types of interventions

Studies with decision aids developed to improve SDM between patients and providers regarding their pain management will be included. We will not limit inclusion based on the format of the decision aid (eg, paper-based and digital). Decision aids without a pain management component or developed to support healthcare provider decision making alone will not be included. Interventions to improve SDM that are not decision aids (eg, patient coaching) will not be included.

Types of participants

We will include studies and decision aids related to acute and chronic pain defined by the International Association for the Study of Pain as ‘an unpleasant sensory and emotional experience associated with, or resembling that associated with, real or potential tissue damage’.⁴⁴ Chronic pain, defined as pain lasting 3 months or longer, includes primary (pain as the disease entity)⁴⁵ and secondary (pain associated with an underlying condition)⁴⁴ pain conditions. Study eligibility will not be restricted based on age; however, we will classify decision aids according to their intended patient population (eg, children/adolescents, older adults >65 years). Additionally, we will classify whether decision aids were aimed at patients, caregivers or both.

Outcome measures

We will extract all reported outcomes from eligible studies. Outcomes will be classified across three primary domains: (1) decisional outcomes, (2) clinical outcomes and (3) implementation outcomes (table 1). Decisional outcomes will be further categorised into intrapersonal and interpersonal domains. Intrapersonal decisional outcomes are factors internal to the individual (eg, decisional conflict, decision self-efficacy and treatment expectancy), whereas interpersonal decisional outcomes capture relational aspects relevant to the clinical encounter (eg, patient-provider alliance, communication quality, trust and perceived invalidation). Other outcomes not included here will be described as ‘other’. Identification of outcomes will be collected regardless of what time point in the study they are collected. For paediatric studies, we will denote whether the outcome assessment was completed by the patient or caregiver.

Table 1. Decision aid impact outcome domains.

Outcome domains	Example constructs and measures
Decisional
Intrapersonal	Extent of shared decision making (eg, shared decision-making questionnaire), decision self-efficacy (eg, decision self-efficacy scale), decisional (eg, decision regret scale), decisional conflict (eg, decisional conflict scale)
Interpersonal	Communication quality, patient–provider trust (eg, working alliance inventory), perceived validation
Clinical
Process	Treatment adherence (eg, treatment adherence phone interview), treatment expectancy (eg, treatment expectancy questionnaire)
Endpoint	Pain (eg, intensity Visual Analogue Scale (VAS), unpleasantness VAS), functional disability (eg, functional disability index), quality of life (eg, Pediatric Quality of Life)
Implementation
	Feasibility (eg, recruitment rate), usability (eg, system usability scale), patient and provider acceptability (eg, acceptability of intervention measure)

Search strategy for identification of relevant studies

We designed and conducted a search strategy in collaboration with a biomedical librarian (CW). We conducted a systematic search across three databases recommended by the Institute of Medicine, including PubMed, CINAHL and Embase. The search strategy was initially formulated for PubMed (online supplemental appendix 1) and then adapted as necessary for use with the remaining two databases. Databases were searched from the time of their inception to the time of the conducted search (January 2026). All publications were restricted to English.

Selection of studies

Search results will be uploaded into a systematic review software (Covidence, Melbourne, AUS). Prior to title and abstract review, all team members will undergo training to ensure familiarity with the review purpose and identified inclusion/exclusion criteria. A random selection of n=50 study titles and abstracts will be used for training purposes. Following training, team members will independently review titles and abstracts to determine eligibility. The Covidence software makes determinations once two unique reviewers have entered a decision on a study. Studies that were given the determination ‘yes’ by both the reviewers will be automatically moved into the full-text screening section, whereas those with two ‘no’ decisions will be identified as irrelevant and removed. A third reviewer (CWH) will spot-check the list of irrelevant studies to ensure accuracy. Covidence will also automatically identify disagreements in reviewer determinations, which will then be resolved through independent examination by the third reviewer. If any questions or uncertainties arise, a fourth reviewer (YZ-I) will be consulted. Eligible publications will then undergo full-text screening using the same review process as above to confirm inclusion criteria are met.

Assessment of methodological quality of included studies

To assess the quality of included studies, we will use the Mixed Methods Appraisal Tool (MMAT)⁴⁶ given its ability to be flexibly applied to a variety of study designs (qualitative, randomised and non-randomised controlled trials, and mixed-method design). The MMAT consists of 15 total items with varying items per design type (qualitative (6 items), quantitative experimental (3 items), quantitative observational (3 items), mixed-methods (3 items)). To improve consistency, quality assessment will be completed by study design groups. To initiate quality assessment, reviewers will separate studies into one of the four study design categories outlined by the MMAT. It is possible that studies will fall into multiple study categories, in which case, they will be categorised as mixed methods to ensure all applicable design criteria are reviewed. Once group consensus is reached on study design allocation, two reviewers will independently apply the MMAT criteria to each study and document their assessment in a quality assessment form created by the senior author. Once independent assessment is completed for all studies in a study design group, the review team and senior author will meet to discuss and resolve any discrepancies. This same process will be followed for all study-design subgroups. Once all studies have been assessed, we will create a summary table presenting which quality criteria were met and the total quality score for each study. In future studies, we also plan to evaluate decision aid quality once we have a more comprehensive understanding of the current scope and depth of decision aids for pain management.

Data extraction and management

For each study, data will be extracted using a standardised data extraction form. Single decision aids may have multiple studies that meet review criteria (eg, development paper and implementation paper). In these instances, all studies that meet criteria will be included in the review, with their common decision aid noted. A preliminary data extraction form has been created and will be pilot tested on a subset of included studies. The drafted extraction sheet includes 4 sections, including (1) basic bibliographic information, (2) decision aid design characteristics (eg, target user, pain condition, number of treatment options and inclusion of values clarification), (3) development process features (eg, use of a standardised approach and co-design or stakeholder involvement), and (4) outcomes used to evaluate impact, including identification of outcome domains for primary and secondary outcomes, measures used and the general direction of the outcome (eg, positive, neutral and negative). The extraction form may be revised according to user feedback to ensure usability and comprehensiveness. Once finalised, studies will be allocated across team members who will independently extract data from included studies. If data presented in the study are unclear or a reviewer is uncertain about the presented data, we will engage in a team discussion to clarify and support data extraction. If aspects of the data are unavailable, it will be noted as such in the extraction form. Senior members of the research team will review the final data extraction form for completeness and spot-check a proportion of the studies for accuracy. Additionally, throughout the data extraction process, the research team will meet to discuss challenges or questions to increase consistency in data extraction across reviewers.

Data synthesis and presentation

Given the anticipated heterogeneity in pain conditions, decision aid formats, development processes and evaluation methods, quantitative synthesis or meta-analysis is not planned. Instead, narrative synthesis will be used to present findings. Aligned with the guidance of Popay et al,⁴⁷ we will adopt an iterative approach in which we (1) identify theories related to the intervention under study (ie, decision aids), (2) create preliminary synthesis and identify relevant patterns, (3) explore relationships in the data and (4) assess and describe the robustness of our synthesis.

To begin step 1, we will be broadly guided by the theory that characteristics of decision aids and the approaches used to design them are related to the impact a decision aid has across important outcome domains (table 1). While this will be a guiding theory, after reading the included studies, we will refine and identify specific theories to examine in steps 2 through 4. In step 2, we will use general descriptive and visual summaries (eg, tables and graphs) to present the characteristics of currently available decision aids (eg, target condition, target user, treatment options and inclusion of values clarification), descriptions of how currently available decision aids were developed (eg, systematic review and focus groups, with stakeholder involvement), and what outcome domains are most commonly used to assess the impact of decision aids for pain management (eg, feasibility, functional disability and extent of SDM). These findings are planned to be presented in tabular format and grouped by decision aid to allow for visual analysis and identification of patterns in the data which will inform step 3 and subgroup analyses. In step 3, we will examine commonalities and differences across decision aids. Relationships of interest will be identified through steps 1 and 2 and may include separating decision aids according to their implementation outcomes (positive, neutral and negative) to assess for characteristics or development approach differences. We may also group decision aids according to their development process, separating those who adopted a co-design approach and those who did not, to examine differences in reported outcomes. It is possible that outcomes may differ within a single study (eg, positive implementation outcomes, neutral or negative clinical outcomes). If this emerges, it will both prompt further pattern evaluation to understand what patterns exist related to the impact decision aids have on different outcomes and will be integrated into the narrative synthesis of the findings, which allows for nuanced explanation of observed outcomes. In step 4, we will present a summary of the methodological quality of the included studies to highlight the robustness of our synthesis. This summary will primarily synthesise the results of the MMAT for each study and highlight common strengths and gaps in the included studies.

Subgroup analysis

A component of our step 3 will be to examine how relationships between the data differ across age groups. Based on existing knowledge of the literature, we anticipate that decision aids will exist across differing age groups. As such, we will make a distinction between decision aids for children/adolescents (<18 years), those for adults (≥18–64 years), and those designed for older adults (>65 years). It is possible that a further collapse of these age differences may result in two subgroups (children/adolescents and adults), given the documented limitations to our current involvement of children in healthcare decision making.^{34 35 48} In addition, we will distinguish between decision aids designed to support the management of acute pain (eg, labour pain) and those designed to support chronic pain, including primary (eg, fibromyalgia) and secondary pain conditions (eg, osteoarthritis). Subgroup analyses will be informed by steps 1 and 2 and may focus on differences in the design and development of decision aids for these differing patient populations. The goal of subgroup analyses will be to illuminate where necessary differences exist to meet the needs of the patient population and where disparities in decision aids may still exist regarding age or presenting concern. For example, we may observe that most decision aids that use a co-design approach are those designed for adults with acute pain concerns, highlighting a gap in current decision aid development to expand this co-design approach to other age groups (eg, adolescents) and pain concerns (eg, fibromyalgia).

Ethics and data dissemination

Chronic pain is a complex condition that requires an individualised and collaborative approach to care. SDM is central to helping patients understand their options and participate in meaningful collaboration with their healthcare provider(s) to develop and implement a treatment plan for pain management. The use of a decision aid to support SDM is especially relevant to chronic pain management where treatment is typically longitudinal and requires self-management. Additionally, available evidence-based treatment options are often preference sensitive, requiring consideration of accompanying trade-offs such as increased functioning at the risk of increased pain or vice versa. While decision aids have been implemented in other health sectors (eg, cancer care) little is known about what current decision aids for pain exist and how they were developed. This protocol outlines methods for a systematic review to identify and characterise current decision aids for pain management across the lifespan, including assessment of decision aid quality, overviewing the processes of decision aid development and identifying the outcomes used to assess the impact of developed decision aids. This review will focus on analysis of secondary data and does not require ethics review.

Through identification of existing pain-related decision aids, the findings of this review will be disseminated widely to target researchers, clinicians and patients. We will disseminate our findings through journal publication, conference presentation and in partnership with patient advocacy groups. Given the established importance of SDM in healthcare, a collated discussion of currently available decision aids for pain management will inform providers interested in improving SDM in their pain care, including guiding them in decision aid tool selection for their clinic. It may also support patients who wish to advocate for increased SDM within their clinical encounters. This review will also reveal current development practices for creating decision aids, and common outcome measures to assess the impact of decision aids, which can guide future research efforts focused on increasing SDM in pain care. A review and quality assessment of existing decision aids is anticipated to be especially beneficial for the development of decision aids to support paediatric pain care, a population often left out of SDM intervention research. This is particularly concerning as paediatric care has added barriers and complexities regarding SDM, including the need to navigate decision preferences between the patient and their caregivers as well as facilitating shared decision-making between families and, often, more than one healthcare provider.