First Things First: How to Elicit the Initial Program Theory for a Realist Evaluation of Complex Integrated Care Programs.

Policy Points Realist evaluation (RE) is an emerging and promising research approach for evaluating integrated care, addressing what works, how, for whom, and in what circumstances. The rich philosophical foundation of RE, critical realism, can help to systematically unravel an integrated care program's initial theory prior to implementation, as a first step within RE. RE can be considered a robust methodological asset in integrated care research by facilitating a deeper level of insight into program functioning than traditional forms of evaluation do and by shaping a realist-informed monitoring and evaluation process. CONTEXT: The complexity of integrated care and the need for transferable evaluation insights ask for a suitable evaluation paradigm. Realist evaluation (RE), underpinned by the philosophy of critical realism, is a theory-driven approach that addresses what works, how, for whom, and in what circumstances. The current study illustrates the process needed for RE's first step: eliciting the initial program theory (IPT). The TARGET program, a Dutch primary care initiative to facilitate more integrated care for chronically ill patients, i.e., care that is efficient, tailored, and holistic,  was taken as a real-world case. METHODS: An RE approach informed the phased IPT elicitation: (1) identifying an abstract theory framework; (2) formulating the preliminary IPT, building on the abstract theory and informed by previous scientific studies that underpin TARGET; and (3) refining the preliminary IPT, informed by RE expert interviews (n = 7). An RE heuristic tool, specifying the interplay between intervention-context-actors-mechanisms-outcomes (ICAMO) and retroductive reasoning, was applied to synthesize the underlying theory of individual TARGET components into TARGET's IPT. FINDINGS: Separate but related IPTs were identified for the two main types of actors involved in TARGET: primary care professionals (PCPs) and patients. For both actors, two sorts of mechanisms are assumed to be activated by TARGET, which-via instrumental outcomes-contribute to long-term quadruple aim targets. The first is confidence to enhance PCPs' person-centered conversational skills and to increase patients' active engagement in TARGET. The second is mutual trust, between PCPs and patients and between PCPs and their network partners. A supportive context is assumed crucial for activating these mechanisms-for example, sufficient resources to invest in integrated care. CONCLUSIONS: Although the IPT elicitation process is time intensive and requires a mind shift, it facilitates a deeper insight into program functioning than accommodated by the prevailing experimental designs in integrated care. Furthermore, the design of a realist-informed evaluation process can be informed by the IPT.

The Patient Centered Assessment Method (PCAM) for Action-Based Biopsychosocial Evaluation of Patient Needs: Validation and Perceived Value of the Dutch Translation.

The Patient Centered Assessment Method (PCAM) is an action-based tool that supports professionals to engage in a biopsychosocial assessment with patients and measure their needs. It is a promising tool for person-centered care. As the Netherlands lacks such a tool, a Dutch version was developed. Furthermore, we aimed to contribute to the relatively limited insights into the psychometric properties and value of the tool when used as part of a needs assessment in primary care. Confirmatory factor analysis was used to study construct validity and Cronbach's alpha was computed to assess reliability. Furthermore, we interviewed 15 primary care professionals who used the PCAM. It was confirmed that each PCAM domain measures a separate construct, informed by the biopsychosocial model. The tool showed adequate reliability (Cronbach's alpha = 0.83). Despite face validity concerns, the tool was mainly valued for measurement of patient needs and to facilitate action planning. Criticism of the PCAM pertained to a limited focus on the patient perspective, which is one of the crucial aspects of person-centered care. These rich, mixed-method insights can help to improve the value of the PCAM, as one of the few multifunctional tools to support professionals in holistic assessments.

Relevant patient characteristics for guiding tailored integrated diabetes primary care: a systematic review.

AimTo identify which patient-related effect modifiers influence the outcomes of integrated care programs for type 2 diabetes in primary care. BACKGROUND: Integrated care is a widespread management strategy for the treatment of type 2 diabetes. However, most integrated care programs are not tailored to patients' needs, preferences and abilities. There is increasing consensus that such a patient-centered approach could improve the management of type 2 diabetes. Thus far, it remains unclear which patient-related effect modifiers should guide such an approach. METHODS: PubMed, CINAHL and EMBASE were searched for empirical studies published after 1998. A systematic literature review was conducted according to the PRISMA guidelines.FindingsIn total, 23 out of 1015 studies were included. A total of 21 studies measured the effects of integrated diabetes care programs on hemoglobin A1c (HbA1c) and three on low-density lipoprotein cholesterol, systolic blood pressure and health-care utilization. In total, 49 patient characteristics were assessed as potential effect modifiers with HbA1c as an outcome, of which 46 were person or health-related and only three were context-related. Younger age, insulin therapy and longer disease duration were associated with higher HbA1c levels in cross-sectional and longitudinal studies. Higher baseline HbA1c was associated with higher HbA1c at follow-up in longitudinal studies. Information on context- and person-related characteristics was limited, but is necessary to help identify the care needs of individual patients and implement an effective integrated type 2 diabetes tailored care program.

Profiling Patients' Healthcare Needs to Support Integrated, Person-Centered Models for Long-Term Disease Management (Profile): Research Design.

BACKGROUND: This article presents the design of PROFILe, a study investigating which (bio)medical and non-(bio)medical patient characteristics should guide more tailored chronic care. Based on this insight, the project aims to develop and validate 'patient profiles' that can be used in practice to determine optimal treatment strategies for subgroups of chronically ill with similar healthcare needs and preferences. METHODS/DESIGN: PROFILe is a practice-based research comprising four phases. The project focuses on patients with type 2 diabetes. During the first study phase, patient profiles are drafted based on a systematic literature research, latent class growth modeling, and expert collaboration. In phase 2, the profiles are validated from a clinical, patient-related and statistical perspective. Phase 3 involves a discrete choice experiment to gain insight into the patient preferences that exist per profile. In phase 4, the results from all analyses are integrated and recommendations formulated on which patient characteristics should guide tailored chronic care. DISCUSSION: PROFILe is an innovative study which uses a uniquely holistic approach to assess the healthcare needs and preferences of chronically ill. The patient profiles resulting from this project must be tested in practice to investigate the effects of tailored management on patient experience, population health and costs.

Nutritional status of children and young adults with Ewing sarcoma or osteosarcoma at diagnosis and during multimodality therapy.

OBJECTIVE: Objective of our study was to evaluate the nutritional status and growth of children and adolescents with common malignancies of the musculoskeletal system at diagnosis, and undergoing multimodality therapy. METHODS: A retrospective analysis of data from 2001 to 2009 was conducted. Hospital charts were used as a source of clinical data. Primary endpoint of the analyses was to identify variations in anthropometric parameters at diagnosis and during the first 2 years of follow-up in children and adolescents with osteosarcoma or Ewing sarcoma. Factors contributing to disorders of growth in this population were sought. RESULTS: A total of 139 children were registered, 62 with Ewing sarcoma and 77 with osteosarcoma. At diagnosis 72.7% of all patients were classified as adequately nourished (BMI 5th to <85th percentiles). During treatment all anthropometric parameters were markedly reduced (P < 0.001) in both groups with extreme changes in body weight from -30% to +44%. This was pronounced in children affected by osteosarcoma (P < 0.05). During follow-up, recovery of body weight was noted in both groups. Height Z-scores remained low (P < 0.001) in comparison to the general population. After the observation period 43.4% of the children with osteosarcoma and 25.5% of the patients with Ewing sarcoma demonstrated an altered body mass. CONCLUSIONS: Pediatric patients with Ewing sarcoma or osteosarcoma are at an increased risk for developing malnutrition, in the form of either over- or underweight during multimodality therapy. Early recognition of abnormal body mass is required to prevent and to treat long-term comorbidities caused by malnutrition.