Generating Items for Measuring Needs-Based Quality of Life and Self-Perceived Health Inequity in Patients with Multimorbidity: Development of the MultiMorbidity Questionnaire (MMQ).

Purpose: To describe the processes of developing domains and items for the MultiMorbidity Questionnaire (MMQ), a multimorbidity-specific PROM for the assessment of Needs-based QoL. Patients and Methods: We developed items and domains for the MMQ through 17 qualitative content validity questionnaire interviews with adults with multimorbidity by testing items from an item bank (covering items with content inspired by existing Needs-based QoL measures for single diseases). The interviews alternated between an explorative part and more focused cognitive interview techniques. Results: Testing the 47 items from the first draft of the MMQ items showed that the Needs-based approach as a framework did not cover all the QoL aspects our informants stated as being important. Therefore, the conceptual framework was supplemented by Self-perceived health inequity, and new items were generated. MMQ, measuring Needs-based QoL (MMQ1) and Self-perceived health inequity (MMQ2), was assembled. MMQ1 covers the domains: "Physical ability" (10 items), "Limitations in everyday life" (15 items), "Worries" (11 items), "My social life" (11 items), "Self-image" (12 items), and "Personal finances" (2 items). Self-perceived health inequity proved to be a relevant framework for other aspects of QoL not covered by the Needs-based approach to QoL. MMQ2 covers the domains: "Experiences of being stigmatized" (five items), "Experiences of not being seen and heard" (four items), "Insufficient understanding of the burden of disease" (three items) and "Experiences of feeling powerless" (five items). Conclusion: We have developed the final MMQ draft, a multimorbidity-specific PROM for the assessment of Needs-based QoL (MMQ1) and Self-perceived health inequity (MMQ2) with high content validity (regarding content relevance and comprehensiveness). The final MMQ draft will be assessed for its psychometric properties using Modern Test Theory.

The patients' perspective on multimorbidity and polypharmacy and how do we accommodate it in the healthcare system.

Patients living with multimorbidity, and polypharmacy can have difficulties handling the treatment burden they face daily. They often experience disjointed treatment courses and demand a more holistic approach to their multimorbidity and to be involved in decisions about their treatments. In the healthcare system, there are examples of new initiatives that go beyond the classic diagnostic silo thinking. However, this review finds that further development of new structures, approaches, and collaboration models in the healthcare system, as well as research, is still necessary to meet the needs of these patients.

Measuring needs-based quality of life and self-perceived health inequity in patients with multimorbidity: investigating psychometric measurement properties of the MultiMorbidity Questionnaire (MMQ) using primarily Rasch models.

BACKGROUND: Multimorbidity is a burden for the individual and to the healthcare sector worldwide, leading to a rising number of intervention studies towards this patient group. To measure a possible effect of such interventions, an adequate patient-reported outcome measure (PROM) is essential. The aim of this study was to assess the draft MultiMorbidity Questionnaire (MMQ), a PROM measuring needs-based quality of life and self-perceived inequity in patients with multimorbidity, for its psychometric properties and to adjust it accordingly to create a content- and construct valid measure. METHODS: The draft MMQ was sent to 1198 eligible respondents with multimorbidity. Modern test theory and classical test theory were used to analyse data. Dimensionality of the suggested domains and invariance of the items were assessed through item analysis, examining the fit to a psychometric model. RESULTS: The psychometric analyses were based on responses from 390 patients with multimorbidity. In the MMQ1, measuring needs-based QoL, evidence of six unidimensional scales was confirmed: physical ability (6 items), worries (6 items), limitations in everyday life (10 items), my social life (6 items), self-image (6 items), and personal finances (3 items). The psychometric analyses of the MMQ2 outlined four unidimensional scales measuring the feeling of Self-perceived inequity in patients with multimorbidity: experiences of being stigmatised (4-5 items), Experiences of insufficient understanding of the burden of disease (3 items), Experiences of not being seen and heard (4 items), Experience of powerlessness (5 items). These scales are relevant for patients' with multimorbidity encounters with (1) their general pratitioner, (2) staff at their general practitioner's surgery, (3) healthcare professionals, (4) staff at the local authorities and (5) friends, family, and others. CONCLUSION: The MMQ, a QoL measure for patients living with multimorbidity has been validated: the MMQ1 is a condition-specific PROM with adequate psychometric properties designed to measure needs-based QoL. The MMQ2 measuring Self-perceived inequity, has also been found to possess adequate measurement properties; however due to the risk of type 2 error a revalidation of MMQ2 is suggested.

The SOFIA pilot study: assessing feasibility and fidelity of coordinated care to reduce excess mortality and increase quality of life in patients with severe mental illness in a general practice setting; a cluster-randomised pilot trial.

OBJECTIVE: To evaluate the feasibility and fidelity of implementing and assessing the SOFIA coordinated care program aimed at lowering mortality and increasing quality of life in patients with severe mental illness by improving somatic health care in general practice. DESIGN: A cluster-randomised, non-blinded controlled pilot trial. SETTING: General Practice in Denmark. INTERVENTION: The SOFIA coordinated care program comprised extended structured consultations carried out by the GP, group-based training of GPs and staff, and a handbook with information on signposting patients to relevant municipal, health, and social initiatives. PATIENTS: Persons aged 18 years or older with a diagnosis of psychotic, bipolar, or severe depressive disorder. MAIN OUTCOME MEASURES: We collected quantitative data on the delivery, recruitment and retention rates of practices and patients, and response rates of questionnaires MMQ and EQ-5D-5 L. RESULTS: From November 2020 to March 2021, nine practices were enrolled and assigned in a 2:1 ratio to the intervention group (n = 6) or control group (n = 3). Intervention group practices included 64 patients and Control practices included 23. The extended consultations were delivered with a high level of fidelity in the general practices; however, thresholds for collecting outcome measures, and recruitment of practices and patients were not reached. CONCLUSION: Our findings suggest that delivering the coordinated care program in a fully powered trial in primary care is likely feasible. However, the recruitment methodology requires improvement to ensure sufficient recruitment and minimize selective inclusion. TRIAL REGISTRATION: The date of pilot trial protocol registration was 05/11/2020, and the registration number is NCT04618250.

Conceptualisation of a measurement framework for Needs-based Quality of Life among patients with multimorbidity.

BACKGROUND: Multimorbidity is both an individual and societal problem. For society, patients with multimorbidity increase healthcare costs. For the individual, living with multimorbidity is complex, and there is an inverse relationship between a patient's Quality of Life (QoL) and their number of chronic conditions. Numerous intervention studies target these problems, yet there is no multimorbidity-specific patient-reported outcome measure (PROM) developed specifically for this group with adequate measurement properties to assess QoL. This study explores what overall needs regarding QoL are affected by living with multimorbidity through qualitative interviews. With this, we conceptualise Needs-based QoL specifically for this group, ensuring high content validity (regarding relevance and comprehensiveness) of using the Needs-based approach to measure their QoL. This is essential as this preliminary study leads to the development of the MultiMorbidity Questionnaire (MMQ), a PROM measuring QoL among patients with multimorbidity. METHODS: This study draws upon qualitative interviews with fifteen patients with multimorbidity based on a semi-structured interview guide following the Needs-based approach. This approach allowed the patients to cover needs relevant for their QoL in relation to the complexities of living with multimorbidity. The transcribed interviews were thematically analysed, inspired by Braun and Clarke's reflexive approach. RESULTS: Analysis of the interviews resulted in the construction of six intertwined domains relevant to patients with multimorbidity, covering their Needs-based QoL; "Physical ability", "Self-determination", "Security", "Partner and social life", "Self-image", and "Personal finances". "Physical limitations" and "Personal finances" were stated as core needs implicating the other domains. CONCLUSION: This study shows six intertwined overall domains relevant for patients with multimorbidity regarding their Needs-based QoL; "Physical ability", "Self-determination", "Security", "Partner and social life", "Self-image", and "Personal finances". These needs are relevant in a Danish context, with a generally high standard of living. Based on this conceptual framework of Need-based QoL for patients with multimorbidity, we will develop items for a new patient-reported outcome measure called the MMQ.

Validity of Current Assessment Tools Aiming to Measure the Affective Component of Pain: A Systematic Review.

The objective of this study was to identify patient-reported outcome measures (PROMs), which aim to measure the affective component of pain and to assess their content validity, unidimensionality, measurement invariance, and Internal consistency in patients with chronic pain. The study was reported according to the PRISMA guidelines. A protocol of the review was submitted to PROSPERO before data extraction. Eligible studies were any type of study that investigated at least one of the domains: PROM development, content validity, dimensionality, internal consistency, or measurement invariance of any type of scale that claimed to measure the affective component of pain among patients with chronic pain. The databases Medline, Embase, PsycINFO, and the Cochrane Library were searched for eligible studies. The database search was supplemented by looking for relevant articles in the reference list of included studies, ie backtracking. All included studies were assessed independently by two authors according to the "COSMIN methodology on Systematic Reviews of Patient-Reported Outcome Measures". Descriptive data synthesis of the identified PROMs was conducted. The search yielded 11,242 titles of which 283 were assessed at the full-text level. Full-text screening led to the inclusion of 11 studies and an additional 28 studies were identified via backtracking, leading to the inclusion of 39 studies in total in the review. Included studies described the development and validity of 10 unique PROMs, all of which we assessed to have potentially inadequate content validity and doubtful psychometric properties. No studies reported whether the PROMs possessed invariant measurement properties. The existing PROMs measuring affective components of chronic pain potentially lack content validity and have inadequate psychometric measurement properties. There is a need for new PROMs measuring the affective component of chronic pain that possess high content validity and adequate psychometric measurement properties.

Specific Measures of Quality of Life in Patients with Multimorbidity in Primary Healthcare: A Systematic Review on Patient-Reported Outcome Measures' Adequacy of Measurement.

PURPOSE: The aim of this study is to search systematically for Patient Reported Outcome Measures (PROMs) used among patients with multimorbidity. Furthermore, the aim is to evaluate the adequacy and validity of the PROMs identified. DESIGN AND SETTING: This systematic review follows the PRISMA guidelines. To assess the adequacy and validity of the identified PROMs the COSMIN Risk of Bias Checklist is used, more specifically a validation of the development, content validity, structural validity, and internal consistency of the PROMs. RESULTS: Four PROMs were identified in the primary search, and one was found from references. The sixth PROM was published after the primary search. None of the identified PROMs were aimed specifically at measuring the quality of life in patients with multimorbidity. According to the checklist, the development process and content validity were rated "adequate" in only one measure and "invalid"/"doubtful"/"inadequate" in the rest of the measures. The structural validity of the measures was rated "adequate" in four measures and "very good" in one. Regarding the internal consistency, two measures were rated doubtful and three "very good". None of the six PROMs reported analyses about invariant measurement. The COSMIN Risk of Bias Checklist proved easy to use; however, there are some concerns in the rating of bias, that are discussed further. CONCLUSION: All six PROMs developed for patients with multimorbidity identified possessed inadequacy in their measurement properties. Therefore, the aim for the future is to develop a valid and adequate measure of the quality of life among patients with multimorbidity.