Protocol for development, calibration and validation of the Patient-Reported Inventory of Self-Management of Chronic Conditions (PRISM-CC)

Abstract

IntroductionAssessing and measuring patients’ chronic condition self-management needs are critical to quality health care and to related research. One in three adults around the world live with multiple chronic conditions. While many patient-reported measures of self-management have been developed, none has emerged as the gold standard, and all have one or more of the following limitations: (1) they fail to measure the different domains of self-management important to patients, (2) they lack sufficient specificity to support patient-centred care or identify the specific components of self-management interventions that work and/or (3) they lack suitability for patients with multiple chronic conditions.Methods and analysisThe Patient-Reported Inventory of Self-Management of Chronic Conditions (PRISM-CC) is being developed to overcome these shortcomings. It will measure respondents’ perceived success (or difficulty) in self-managing seven domains important to patients. The protocol has three phases. Phase 1 is conceptual model development and item generation. Phase 2 is assessment of the relevance and understanding of items by people with chronic conditions. Phase 3 is item analysis, dimensionality assessment, scaling and preliminary validation of the PRISM-CC using an online survey of people with chronic conditions (n~750). The expected completion date is early 2021.Ethics and disseminationThis study will adhere to the Canadian Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans. Ethics approval for all phases has been obtained from the Nova Scotia Health Authority Research Ethics Board. Once completed, the PRISM-CC will be made available for research and healthcare at minimal to no cost.

Item selection, scaling and construct validation of the Patient-Reported Inventory of Self-Management of Chronic Conditions (PRISM-CC) measurement tool in adults

“…To address this, further assessment of measurement equivalence across patients with different socio-demographic and chronic disease attributes is needed. Confirmation of a priori, hypothesized associations between PRISM-CC domains and variables, as detailed in the study protocol [19], provides additional evidence of construct validity. While this is encouraging, additional evidence of validity is needed.…”

“…The first step in development was to operationally reframe the seven TEDSS domain definitions to reflect perceived success or difficulty in self-managing each domain (Table 1 ). Item generation (Phase 1) and assessment of relevance and understanding to people living with chronic conditions (Phase 2) are previously reported [ 19 ]. Briefly, item development and selection were conducted by an international, multidisciplinary study team, which included clinicians, researchers and people living with chronic conditions.…”

“…As per our published protocol [ 19 ], analyses proceeded through item selection, model refinement and then assessment of construct validity. Confirmatory factor analysis (CFA) and item response theory (IRT) models provided complementary approaches to inform item selection, scaling, and assessment of construct validity of the PRISM-CC [ 32 , 33 ].…”

“…Development of the PRISM-CC followed the Patient-Reported Outcomes Measurement Information System (PROMIS) ® Scientific Standard [19] and the COSMIN Study Design checklist for Patient-Reported outcome measures [22][23][24]. The first step in development was to operationally reframe the seven TEDSS domain definitions to reflect perceived success or difficulty in self-managing each domain (Table 1).…”

“…The Patient-Reported Inventory of Self-Management of Chronic Conditions (PRISM-CC) is a new, patient-reported instrument designed to address the limitations of existing measures [ 19 ]. Designed to be applicable to patients living with multiple chronic conditions, it will differentiate domains of self-management relevant to patient experiences, and be feasible for use in diverse settings.…”