Considerations to Support Use of Patient-Reported Outcomes Measurement Information System Pediatric Measures in Ambulatory Clinics.

OBJECTIVE: To identify challenges to the use of Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric measures in the ambulatory pediatric setting and possible solutions to these challenges. STUDY DESIGN: Eighteen semistructured telephone interviews of health system leaders, measurement implementers, and ambulatory pediatric clinicians were conducted. Five coders used applied thematic analysis to iteratively identify and refine themes in interview data. RESULTS: Most interviewees had roles in leadership or the implementation of patient-centered outcomes; 39% were clinicians. Some had experience using PROMIS clinically (44%) and 6% were considering this use. Analyses yielded 6 themes: (1) selection of PROMIS measures, (2) method of administration, (3) use of PROMIS Parent Proxy measures, (4) privacy and confidentiality of PROMIS responses, (5) interpretation of PROMIS scores, and (6) using PROMIS scores clinically. Within the themes, interviewees illuminated specific unique considerations for using PROMIS with children, including care transitions and privacy. CONCLUSIONS: Real-world challenges continue to hamper PROMIS use. Ongoing efforts to disseminate information about the integration of PROMIS measures in clinical care is critical to impacting the health of children.

Content validity of the PROMIS® pediatric family relationships measure for children with chronic illness.

BACKGROUND: Families play a critical role in supporting the health and well-being of children with chronic illnesses, who face a lifetime of responsibility for self-management of their condition. Our goal was to investigate whether the novel Patient-Reported Outcomes Measurement Information System® (PROMIS®) Pediatric Family Relationships measure, developed primarily within the general pediatric population, reflects the experiences of family relationships for chronically ill children and their parents. METHODS: We conducted semi-structured qualitative interviews with children (aged 8-17) with common chronic conditions: asthma (n = 6), type 1 diabetes (n = 5), or sickle cell disease (n = 5), and separately with one of their parents (n = 16). Interviews were recorded, and two team members independently coded the written transcripts facilitated by Nvivo 10. The systematic content analysis used a combination of: 1) pre-specified themes corresponding to the six facets of the domain identified during measure development and reflected in the content of the items (i.e., Sense of Family; Love and Caring; Value and Acceptance; Trust, Dependability, and Support; Communication; Enjoyment), as well as 2) open-coding, allowing participants to define important concepts (i.e., disease impact). RESULTS: Family relationships were conceptualized in a similar way to the general population, as evidenced by child and parent responses to open-ended questions about family relationships and to specific probes that corresponded with the item content in the Family Relationship 8-item short form. Children spontaneously discussed the impact of their disease on family relationships less often than parents did. Although participants described how living with a chronic illness positively and negatively impacted aspects of family relationships, nearly all participants believed their responses to the PROMIS® Family Relationships items would not change if they (or their child) did not have a chronic illness. CONCLUSIONS: Among a sample of families of children with one of 3 chronic illnesses, participants described family relationships in a way that was consistent with the facets of the PROMIS® Family Relationship domain. This study adds to the content validity of the measure for children with chronic illness.

Patient-centred outcomes research: brave new world meets old institutional policies.

Background: Engaging patients across the research trajectory supports research that is generalizable, high quality, timely and actionable. However, this approach comes with challenges and opportunities as investigators and engaged patient stakeholders encounter institutional policies around patient engagement, privacy and research participant protection. Objective: To describe the resolution and impact of quandaries arising when patient stakeholders' values and preferences conflicted with institutional policies. Methods: Case study from a Patient-Centered Outcomes Research Institute-funded trial. Results: The first example focuses on the tension between the health care organization's requirements for background checks for all patient advisors and the funders' requirement to engage hard-to-reach populations. To create an environment of mutual trust and respect with patient stakeholders, the research team decided against imposing background checks. All 53 patient and parent advisors have served continuously for 2 years and meeting attendance exceeds 95%. The second example describes parent stakeholders' role in revising a letter informing patients about a privacy violation. Among 49 families affected by and informed about this violation, 35 (71%) agreed to participate. The third example focuses on how patient stakeholder preferences about study reminders conflict with the 1996 Health Insurance Portability and Accountability Act rules. While patient stakeholders strongly endorsed text message reminders, regulations and technology do not permit reminders with enough detail to ensure clarity. Although retention rates exceeded 90%, attendance at study appointments was below 75% and below 60% for minority and low socio-economic status families. Conclusion: Patient engagement positively impacts research. Resolving conflicts between patient-engaged research and existing institutional policies and regulations would allow this impact to become fully realized.

Development and validation of the self-management Barriers and Supports Evaluation for working-aged adults with type 1 diabetes mellitus.

INTRODUCTION: To optimize type 1 diabetes mellitus self-management, experts recommend a person-centered approach, in which care is tailored to meet people's needs and preferences. Existing tools for tailoring type 1 diabetes mellitus education and support are limited by narrow focus, lack of strong association with meaningful outcomes like A1c, or having been developed before widespread use of modern diabetes technology. To facilitate comprehensive, effective tailoring for today's working-aged adults with type 1 diabetes mellitus, we developed and validated the Barriers and Supports Evaluation (BASES). RESEARCH DESIGN AND METHODS: Participants 25-64 years of age with type 1 diabetes mellitus were recruited from clinics and a population-based registry. Content analysis of semistructured interviews (n=33) yielded a pool of 136 items, further refined to 70 candidate items on a 5-point Likert scale through cognitive interviewing and piloting. To develop and validate the tool, factor analyses were applied to responses to candidate items (n=392). Additional survey data included demographics and the Diabetes-Specific Quality of Life (QOL) Scale-Revised. To evaluate concurrent validity, hemoglobin A1c (HbA1c) values and QOL scores were regressed on domain scores. RESULTS: Factor analyses yielded 5 domains encompassing 30 items: Learning Opportunities, Costs and Insurance, Family and Friends, Coping and Behavioral Skills, and Diabetes Provider Interactions. Models exhibited good to adequate fit (Comparative Fit Index >0.88 and Root Mean Squared Error of Approximation <0.06). All domains demonstrated significant associations with HbA1c and QOL in the expected direction, except Family and Friends. Coping and Behavioral Skills had the strongest associations with both HbA1c and QOL. CONCLUSIONS: The BASES is a valid, comprehensive, person-centered tool that can tailor diabetes support and education to individuals' needs in a modern practice environment, improving effectiveness and uptake of services. Clinicians could use the tool to uncover patient-specific barriers that limit success in achieving HbA1c goals and optimal QOL.

Outcomes That Matter to Teens With Type 1 Diabetes.

Purpose The purpose of the study was to describe outcomes that matter to teens with type 1 diabetes. Understanding outcomes that matter to teens could support successful interventions to improve diabetes self-management. Methods Fifty publicly available posts published in the "teen" sections of 2 major diabetes online forums between 2011 and 2013 were analyzed using qualitative research methods. From each post, content and descriptive data (eg, duration of diabetes and age) were collected. Two members of the research team independently used open coding techniques to identify outcomes (defined as impacts or consequences of type 1 diabetes) and organized them into themes and subthemes. A codebook was jointly developed to facilitate the identification of meaningful outcomes from the posts. Results Teens' average age was 15.7 years, and the average time since diabetes diagnosis was 6.3 years. The 3 most commonly mentioned outcomes were (1) interactions with peers ("I want to talk to someone who understands"), (2) emotional well-being ("Diabetes makes me want to cry"), and (3) blood glucose management ("My blood sugar never goes down"). Other identified outcomes included (4) physical well-being, (5) education and motivation of others, (6) family interactions, (7) academic achievement, and (8) interactions with important others such as teachers. Conclusions While teens are concerned about control of their blood glucose, there are many other outcomes that matter to them. Health care providers and diabetes educators may want to consider these other outcomes when motivating teens with type 1 diabetes to improve blood glucose control.

The good doctor: a qualitative study of German homeopathic physicians.

OBJECTIVES: The objective of this study was to identify the factors that make a good doctor, both from a patient and a physician perspective. Is there a connection between practicing homeopathy and being a good doctor? METHODS: This was a qualitative study of homeopathically trained physicians and their patients, using observation of patient-physician interactions (n = 29) and interviews with patients (n = 20) and with physicians (n = 4). RESULTS: Patients identified the availability of time, both in itself and as a prerequisite for other physician characteristics, as the single most important factor. Other factors include scope of diagnosis/holistic approach, patient-centeredness/empathy, and perceived competence/therapeutic success. Patients did not link these factors to the homeopathic orientation of their physician, while physicians clearly made this connection. CONCLUSIONS: The findings confirm other studies of patient satisfaction and physician characteristics. The availability of time, a holistic approach, and high physician empathy lead to high patient satisfaction. Homeopathic physicians probably are more likely to exhibit these characteristics. PRACTICE IMPLICATIONS: Health care policy should create conditions that enable individual physicians to be "good doctors." For medical education, a stronger emphasis on interpersonal skills and practitioner empathy could lead to higher patient satisfaction and potentially better treatment outcomes. Homeopathy might provide a good role model for this type of education.

Barriers to routine risk-score use for healthy primary care patients: survey and qualitative study.

BACKGROUND: Risk scores for the primary prevention of chronic diseases in healthy adults are frequently recommended but often underused by general practitioners (GPs). The objectives of this study were to assess the use of and attitudes regarding the use of risk scores among GPs and to identify possible barriers to use. METHODS: Between November 7, 2007, and April 4, 2008, 68 GPs in Berlin, Germany, participated in the survey, and 24 were additionally invited to participate in focus groups. Quantitative data were analyzed descriptively and qualitative data were analyzed according to grounded theory. RESULTS: Survey data of 42 GPs indicated that physicians regularly perform risk assessments for healthy patients, although most did not use risk scores. The usefulness of risk scores was rated largely positive. Focus groups revealed some confusion about the definition of risk scores and that participants resisted general use. Barriers to risk-score use were lack of lifestyle recommendations, regulatory constraints, the patient's role, and lack of accuracy. Suggestions for improvement included computerized risk prediction for multiple diseases simultaneously, better computer-generated visual presentation, and the integration of lifestyle recommendations. CONCLUSIONS: The GPs perceive the routine use of risk scores as infeasible because of regulatory constraints and the nature of the physician-patient relationship. These factors need to be considered to increase risk-score use. Training of physicians could also help somewhat to overcome underuse. Use of computerized approaches that enable the prediction of risks for several chronic diseases simultaneously and improved computer-generated visual presentation may increase acceptance. Risk profiles should further be related to recommendations for health-behavior modification.