Stakeholders' Perspectives on Stakeholder-engaged Research (SER): Strategies to Operationalize Patient-centered Outcomes Research Principles for SER.

BACKGROUND: US federal funding agencies increasingly incentivize stakeholder-engaged research which represents a paradigm shift toward incorporating a range of stakeholders in research design, conduct, and dissemination. OBJECTIVES: We use qualitative methods to capture experience-based recommendations on how to operationalize 4 Patient-Centered Outcomes Research (PCOR) principles in stakeholder-engaged research, specifically: (1) reciprocal relationships; (2) colearning; (3) partnership; and (4) trust, transparency, and honesty. RESEARCH DESIGN: We conducted semistructured interviews with members of a stakeholder panel who participated in a 2-year comparative effectiveness study of cholesterol screening and treatment among young adults. SAMPLE: Participants included 8 young adults and parent panelists and 11 professional panelists (clinicians, researchers, policy developers, and disseminators). MEASURES: The interview guide included questions about the 4 PCOR principles and queried preferred strategies to attain them. Interview transcripts were analyzed using an a priori and emergent coding structure. RESULTS: Participants provided strategies to promote the 4 PCOR principles. Although some stakeholder-identified strategies were complementary, others conflicted due to (1) competing ideologies identified among the principles, and (2) distinct stakeholder preferences. Illustrative of competing ideologies, participants simultaneously preferred receiving relevant articles before calls (to facilitate colearning) but also minimal outside reading (to achieve partnership). Illustrative of distinct stakeholder preferences, young adult and parent panelists generally preferred calls to occur on weekends/evenings, whereas professional panelists preferred mid-week work hours. CONCLUSIONS: Our exploratory study provides stakeholder-identified strategies to achieve the 4 PCOR principles, and demonstrates the need to identify, acknowledge, and address potentially conflicting strategies due to the potential for competing ideologies or variation in stakeholder preferences.

Health-related quality of life in Hodgkin lymphoma: a systematic review.

PURPOSE: Hodgkin Lymphoma (HL) is highly curable with well-established treatment regimens; however, the impact on patient's health-related quality of life (HRQL) from diagnosis through survivorship is unclear. This systematic review aimed to describe the available literature on HRQL in HL, assess the quality of these studies, identify gaps in the literature and recommend further areas of research. METHODS: Following PRISMA guidelines, we performed a systematic review to include studies assessing the HRQL in HL patients. Articles identified through database searches were screened and data extracted. Quality was evaluated using a 6-point scale, adapted from published HRQL systematic reviews. RESULTS: Sixty five articles published between 1986 and 2015 met inclusion criteria. These included 53 (82 %) cross-sectional studies; 12 (18 %) longitudinal studies, including three embedded in randomized trials; and three additional longitudinal studies that began assessment at diagnosis. Study sample sizes of HL patients varied considerably with only five (42 %) longitudinal studies including more than 50 patients. Multidimensional HRQL was assessed in 45 studies, single HRQL domains in 22 studies, and symptoms, including fatigue, in 28 studies. CONCLUSIONS: The majority of studies employed a cross-sectional design, enrolling HL survivors at least 10 years after the completion of therapy. Emphasis on HRQL following therapy may inform initial treatment decisions and long-term survivorship goals. We recommend that future research include prospective, longitudinal randomized designs across both treatment and time.

A systematic review of stakeholder engagement in comparative effectiveness and patient-centered outcomes research.

OBJECTIVES: We conducted a review of the peer-reviewed literature since 2003 to catalogue reported methods of stakeholder engagement in comparative effectiveness research and patient-centered outcomes research. METHODS AND RESULTS: We worked with stakeholders before, during and after the review was conducted to: define the primary and key research questions; conduct the literature search; screen titles, abstracts and articles; abstract data from the articles; and analyze the data. The literature search yielded 2,062 abstracts. The review was conducted on 70 articles that reported on stakeholder engagement in individual research projects or programs. FINDINGS: Reports of stakeholder engagement are highly variable in content and quality. We found frequent engagement with patients, modestly frequent engagement with clinicians, and infrequent engagement with stakeholders in other key decision-making groups across the healthcare system. Stakeholder engagement was more common in earlier (prioritization) than in later (implementation and dissemination) stages of research. The roles and activities of stakeholders were highly variable across research and program reports. RECOMMENDATIONS: To improve on the quality and content of reporting, we developed a 7-Item Stakeholder Engagement Reporting Questionnaire. We recommend three directions for future research: 1) descriptive research on stakeholder-engagement in research; 2) evaluative research on the impact of stakeholder engagement on the relevance, transparency and adoption of research; and 3) development and validation of tools that can be used to support stakeholder engagement in future work.

Transitioning from pediatric to adult health care with familial hypercholesterolemia: Listening to young adult and parent voices.

BACKGROUND: Young adults with familial hypercholesterolemia (FH) are at a critical period for establishing behaviors to promote future cardiovascular health. OBJECTIVE: To examine challenges transitioning to adult care for young adults with FH and parents of FH-affected young adults in the context of 2 developmental tasks, transitioning from childhood to early adulthood and assuming responsibility for self-management of a chronic disorder. METHODS: Semistructured, qualitative interviews were conducted with 12 young adults with FH and 12 parents of affected young adults from a pediatric subspecialty preventive cardiology program in a northeastern academic medical center. Analyses were conducted using a modified grounded theory framework. RESULTS: Respondents identified 5 challenges: (1) recognizing oneself as a decision maker, (2) navigating emerging independence, (3) prioritizing treatment for a chronic disorder with limited signs and symptoms, (4) managing social implications of FH, and (5) finding credible resources for guidance. Both young adults and parents proposed similar recommendations for addressing these challenges, including the need for family and peer involvement to establish and maintain diet and exercise routines and to provide medication reminders. Systems-level recommendations included early engagement of adolescents in shared decision-making with health care team; providing credible, educational resources regarding FH; and using blood tests to track treatment efficacy. CONCLUSION: Young adults with FH transitioning to adult care may benefit from explicit interventions to address challenges to establishing healthy lifestyle behaviors and medication adherence as they move toward being responsible for their medical care. Further research should explore the efficacy of recommended interventions.

Young adult and parent stakeholder perspectives on participation in patient-centered comparative effectiveness research.

AIM: Explore perspectives of adolescent and young adult (AYA) and parent stakeholders regarding their engagement in comparative effectiveness research (CER) evaluating cholesterol screening and treatment strategies for 17-21 year olds. METHODS: All nine AYAs and parent stakeholders participating in a 20-member panel of AYAs, parents and professionals (i.e., clinicians, researchers, policy makers, payers), completed a quantitative survey and a semistructured interview at the completion of the core CER study. RESULTS & CONCLUSION: AYAs and parents stakeholders emphasized the role of power differentials regarding shared knowledge, relationships and trust, and logistics. To mitigate power differentials, stakeholders recommended more materials, clearer definition of roles and in-person meetings. Perceived positive outcomes included diversity of perspectives provided, better understanding their own health and decision-making and improving CER.

Child and adolescent psychiatrists' reported monitoring behaviors for second-generation antipsychotics.

OBJECTIVE: The number of children and adolescents (hereafter referred to as "children") who have been prescribed second-generation antipsychotics (SGAs) has increased over the last decade, but little is known about monitoring practices in pediatric patients who are vulnerable to adverse effects. We examined factors associated with psychiatrists' self-reported monitoring of children who were prescribed SGAs. METHODS: A survey was mailed to a national, randomly selected sample of 1600 child and adolescent psychiatrists from the American Medical Association mailing list. Using logistic regression, we tested whether psychiatrist characteristics, attitudes, and practice characteristics were associated with monitoring (baseline and/or periodic) the following: Patient history, height and weight, blood pressure, waist circumference, lipid and glucose levels, and electrocardiogram. RESULTS: Among the analytic sample of 308, at least two thirds reported monitoring patient history, height and weight, blood pressure, and fasting plasma lipids and glucose; 23% reported monitoring waist circumference; and 12% reported conducting an electrocardiogram. More than one third stated that they routinely monitored thyroid levels and more than half reported monitoring complete blood count and electrolytes/blood urea nitrogen. Psychiatrists reporting that they were able to measure vital signs on site were more likely to measure height and weight. Those who reported feeling comfortable conducting a physical examination were more likely to measure blood pressure. Those answering that the risk of metabolic syndrome was low were less likely to measure blood pressure and waist circumference. Being board certified and able to measure vital signs on site were associated with more monitoring of glucose and lipid levels. Conversely, years in practice and feeling that patients were nonadherent with blood work were associated with less monitoring of glucose and lipid levels. CONCLUSIONS: In this sample, inconsistent monitoring patterns of children prescribed SGAs were found. Efforts to communicate guidelines' evidence base and improve office capacity to measure and track adverse effects are needed to increase appropriate adverse effect monitoring in children who have been prescribed SGAs.

Variations in Physician Attitudes Regarding ADHD and Their Association With Prescribing Practices.

OBJECTIVE: The objective of this study was to test whether physicians' attitudes regarding the impact of ADHD on health-related quality of life (HRQL) explain differences in practices for prescribing psychostimulants in children. METHOD: In a cross-sectional survey, U.S.-based pediatricians and psychiatrists ("physicians") used the Paper-Standard Gamble--a widely used preference-based assessment of HRQL--to rate four vignettes describing ADHD health states of varying severity. Associations between standard gamble scores and questions about prescribing practices were analyzed using ordinal logistic regression. RESULTS: Surveys were mailed to 291 physicians; 127 (44%) returned complete forms. Lower standard gamble scores were associated with more emphasis on children's ADHD symptoms (p = .03) and less emphasis on parents' concerns about stimulant side effects (p = .03) when prescribing psychostimulants. CONCLUSION: Differences in physician perceptions of the severity of ADHD symptoms and in their emphasis on parental concerns about side effects may help explain variations in ADHD psychostimulant prescription patterns.

Evaluation of the economic burden of diseases associated with poor nutrition status.

BACKGROUND: Geriatric acutely ill patients may frequently have insufficient nutrition intake, leading to malnutrition and increased susceptibility to additional morbidity. This compromised health status can increase costs by extending length of stay in the hospital, promoting the development of comorbidities, and requiring more intensive care. Understanding the value of measures improving the health of these patients depends in part on estimating the costs of prevented adverse outcomes. Because clinical trials often do not record these costs, it is difficult to assess the value of nutrition interventions. MATERIALS AND METHODS: This article comprehensively reviews 15 years of clinical trials of nutrition interventions to identify salient diseases and complications measured by previous clinical trials and then estimates costs corresponding with these conditions associated with poor nutrition status. RESULTS: The most costly complication associated with poor nutrition status is acute respiratory infections ($13,350-$19,530 per hospitalization), while institutional long-term care is the greatest chronic cost contributor across many diseases ($77,000 per year of care). CONCLUSION: This review can facilitate imputation of nutrition intervention benefits for acutely ill patients by characterizing the costs of clinical outcomes often reported in trials.

Child and adolescent psychiatrists' attitudes and practices prescribing second generation antipsychotics.

OBJECTIVE: The purpose of this study was to examine psychiatrists' attitudes and practices in prescribing second-generation antipsychotics (SGA) to children and adolescents (referred to here as "children") and identify factors associated with off-label SGA use. METHODS: A survey was mailed to a national, randomly selected sample of 1600 child and adolescent psychiatrists identified by the American Medical Association. Multivariable logistic regression was used to identify factors, including psychiatrists' characteristics, practice characteristics, and psychiatrists' attitudes, that are associated with off-label SGA use (i.e., SGAs used in children with attention-deficit/hyperactivity disorder (ADHD), oppositional defiant disorder, conduct disorder, or nonbipolar mood disorders). RESULTS: The final sample included 340 psychiatrists. Overall, respondents reported higher use and appropriateness of SGAs for United States Food and Drug Administration (FDA)-approved disorders, symptoms of aggression, and older child age. More than one third (36%) of respondents reported some off-label SGA use. Significant predictors of off-label use were: Practicing at inpatient/residential facilities (odds ratio [OR]=4.2, p=0.001); white/non-Hispanic race/ethnicity (OR=0.3, p<0.0001), agreeing that SGAs should be used for ADHD with aggression (OR=7.1, p<0.0001); and agreeing that SGAs should be used for severe delinquent behaviors (OR=1.9, p=0.03). CONCLUSIONS: Psychiatrists' attitudes about prescribing SGAs to children exhibiting aggressive symptoms were associated with off-label SGA use. Research is needed to understand the construct of aggression, potential interaction effects of aggression with diagnostic criteria, and their impact on SGA use.

Survey of United States child and adolescent psychiatrists' cardiac screening practices prior to starting patients on stimulants.

OBJECTIVE: The purpose of this study was to determine psychiatrists' barriers, attitudes, and practices regarding cardiac screening prior to initiating stimulants in children with attention-deficit/hyperactivity disorder. BACKGROUND: Professional and federal oversight organizations recently have debated the evidence regarding sudden cardiac death (SCD) risk with stimulants, and have published guidelines recommending cardiac screening. It is not known how psychiatrists have responded. METHODS: This study was a cross-sectional survey of 1,600 randomly-selected U.S. members of the American Academy of Child and Adolescent Psychiatry. Analyses included descriptive statistics and logistic regression. RESULTS: Response rate was 40%; 96% met eligibility criteria. Barriers to identifying cardiac disorders in general included ability to perform a routine physical examination (74%) and care coordination with primary care providers (35%). Only 27% agreed that SCD risk warranted cardiac assessment. Prior to starting a patient on stimulants, 95% of psychiatrists obtained a routine history. The majority either conducted (9%), or relied on primary care providers to conduct (67%) a physical examination; 26% did not obtain a physical examination. Nineteen percent of psychiatrists ordered an electrocardiogram (ECG), of those, non-mutually exclusive reasons for ordering an ECG included standard practice procedure (62%), clinical findings (27%), medicolegal considerations (25%), and guideline adherence (24%). On multivariate modeling, psychiatrists were less likely to conduct cardiac screening themselves if in private practice (referent: academic medical center), if >50% of their patients had private insurance, or if they believed their ability to perform a physical examination to be a barrier. When modeling cardiac screening performed by any healthcare professional (e.g., psychiatrist, primary care practitioner), screening was less likely if the psychiatrist was practicing in a community mental health center (referent: academic medical center), was male, or if >50% of that psychiatrist's patients had private insurance. CONCLUSION: Findings suggest the tacit interplay between primary care and psychiatry for the assessment and management of medical risks associated with psychotropic medications should be improved, and solutions prioritized.

Cardiac screening prior to stimulant treatment of ADHD: a survey of US-based pediatricians.

OBJECTIVES: To determine pediatricians' attitudes, barriers, and practices regarding cardiac screening before initiating treatment with stimulants for attention-deficit/hyperactivity disorder. METHODS: A survey of 1600 randomly selected, practicing US pediatricians with American Academy of Pediatrics membership was conducted. Multivariate models were created for 3 screening practices: (1) performing an in-depth cardiac history and physical (H & P) examination, (2) discussing potential stimulant-related cardiac risks, and (3) ordering an electrocardiogram (ECG). RESULTS: Of 817 respondents (51%), 525 (64%) met eligibility criteria. Regarding attitudes, pediatricians agreed that both the risk for sudden cardiac death (SCD) (24%) and legal liability (30%) were sufficiently high to warrant cardiac assessment; 75% agreed that physicians were responsible for informing families about SCD risk. When identifying cardiac disorders, few (18%) recognized performing an in-depth cardiac H & P as a barrier; in contrast, 71% recognized interpreting a pediatric ECG as a barrier. When asked about cardiac screening practices before initiating stimulant treatment for a recent patient, 93% completed a routine H & P, 48% completed an in-depth cardiac H & P, and 15% ordered an ECG. Almost half (46%) reported discussing stimulant-related cardiac risks. Multivariate modeling indicated that ≥1 of these screening practices were associated with physicians' attitudes about SCD risk, legal liability, their responsibility to inform about risk, their ability to perform an in-depth cardiac H & P, and family concerns about risk. CONCLUSIONS: Variable pediatrician attitudes and cardiac screening practices reflect the limited evidence base and conflicting guidelines regarding cardiac screening. Barriers to identifying cardiac disorders influence practice.