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BackgroundMaternal weight gain during pregnancy is one of the few potentially modifiable risk factors for many adverse maternal and child health outcomes. Defining the optimal pregnancy weight gain range is difficult because, while lower weight gain may prevent some outcomes, such as maternal and child obesity, it may increase the risk of others such as fetal growth restriction and infant death. These health outcomes vary in their seriousness to mothers and their health care providers, and these differences in seriousness should be taken into account when determining optimal weight gain ranges. However, the relative seriousness that women and their care providers place on different health outcomes is unknown. ObjectiveWe will determine the seriousness of 11 maternal and child health outcomes that have been consistently associated with pregnancy weight gain. We will achieve this by engaging patients and maternal and child health professionals using an online modified Delphi panel process. MethodsWe aim to recruit a racially/ethnically and geographically diverse group of 90 US maternal and child health professionals and 90 women who are pregnant or less than 2 years postpartum. We will conduct 3 concurrent panels using the ExpertLens system, a previously evaluated online modified Delphi system that combines 2 rounds of rating with 1 round of feedback and moderated online discussion. In Round 1, panelists are asked to rate the seriousness of each health outcome on a scale of 0-100 and to provide a rationale for their scores. In Round 2, panelists will review their responses relative to those of other panelists. They will discuss their seriousness ratings anonymously using a moderated online discussion board. In Round 3, participants will revise their Round 1 responses based on group feedback and discussion. Each round will be open for 1-2 weeks. ResultsThe study protocol was reviewed by our ethics boards and did not require approval as human research. A pilot study of 6 professionals and 7 patients was completed in December 2019. ConclusionsOur numeric estimates of the seriousness of maternal and child health outcomes will enable future studies to determine pregnancy weight gain ranges that balance the risks of low and high weight gain for mothers and children. International Registered Report Identifier (IRRID)DERR1-10.2196/16478

BACKGROUND: Clinicians treating cancer-related pain with opioids regularly encounter nonmedical stimulant use (i.e., methamphetamine, cocaine), yet there is little evidence-based management guidance. The aim of the study is to identify expert consensus on opioid management strategies for an individual with advanced cancer and cancer-related pain with nonmedical stimulant use according to prognosis. METHODS: The authors conducted two modified Delphi panels with palliative care and addiction experts. In Panel A, the patients prognosis was weeks to months and in Panel B the prognosis was months to years. Experts reviewed, rated, and commented on the case using a 9-point Likert scale from 1 (very inappropriate) to 9 (very appropriate) and explained their responses. The authors applied the three-step analytical approach outlined in the RAND/UCLA to determine consensus and level of clinical appropriateness of management strategies. To better conceptualize the quantitative results, they thematically analyzed and coded participant comments. RESULTS: Consensus was achieved for all management strategies. The 120 Experts were mostly women (47 [62%]), White (94 [78%]), and physicians (115 [96%]). For a patient with cancer-related and nonmedical stimulant use, regardless of prognosis, it was deemed appropriate to continue opioids, increase monitoring, and avoid opioid tapering. Buprenorphine/naloxone transition was inappropriate for a patient with a short prognosis and of uncertain appropriateness for a patient with a longer prognosis. CONCLUSION: Study findings provide urgently needed consensus-based guidance for clinicians managing cancer-related pain in the context of stimulant use and highlight a critical need to develop management strategies to address stimulant use disorder in people with cancer. PLAIN LANGUAGE SUMMARY: Among palliative care and addiction experts, regardless of prognosis, it was deemed appropriate to continue opioids, increase monitoring, and avoid opioid tapering in the context of cancer-related pain and nonmedical stimulant use. Buprenorphine/naloxone transition as a harm reduction measure was inappropriate for a patient with a short prognosis and of uncertain appropriateness for a patient with a longer prognosis.

IntroductionManagement of opioid misuse and opioid use disorder (OUD) among individuals with serious illness is an important yet understudied issue. Palliative care clinicians caring for individuals with serious illness, many of whom may live for months or years, describe a complex tension between weighing the benefits of opioids, which are considered a cornerstone of pain management in serious illness, and serious opioid-related harms like opioid misuse and OUD. And yet, little literature exists to inform the management of opioid misuse and OUDs among individuals with serious illness. Our objective is to provide evidence-based management guidance to clinicians caring for individuals with serious illness who develop opioid misuse or OUD.Methods and analysisWe chose a modified Delphi approach, which is appropriate when empirical evidence is lacking and expert input must be used to shape clinical guidance. We sought to recruit 60 clinicians with expertise in palliative care, addiction or both to participate in this study. We created seven patient cases that capture important management challenges in individuals with serious illness prescribed opioid therapy. We used ExpertLens, an online platform for conducting modified Delphi panels. Participants completed three rounds of data collection. In round 1, they rated and commented on the appropriateness of management choices for cases. In round 2, participants reviewed and discussed their own and other participants' round 1 numerical responses and comments. In round 3 (currently ongoing), participants again reviewed rounds 1 and 2, and are allowed to change their final numerical responses. We used ExpertLens to automatically identify whether there is consensus, or disagreement, among responses in panels. Only round 3 responses will be used to assess final consensus and disagreement.Ethics and disseminationThis project received ethical approval from the University of Pittsburgh's Institutional Review Board (study 19110301) and the RAND Institutional Research Board (study 2020-0142). Guidance from this work will be disseminated through national stakeholder networks to gain buy-in and endorsement. This study will also form the basis of an implementation toolkit for clinicians caring for individuals with serious illness who are at risk of opioid misuse or OUD.

Background: There is a growing interest in creating large-scale repositories that store genetic, behavioral, and environmental data for future, unspecified uses. The All of Us Research Program is one example of such a repository. Its participants will get access to their personal data and the results of the studies that used them. However, little is known about what researchers should return to participants and how they should do it in a way that is valuable and meaningful to participants. Methods: To better understand the concept of "return of value" and the practice of returning valuable study information, we conducted semi-structured telephone interviews with 44 stakeholders with diverse perspectives on this topic. All interviews have been transcribed and coded thematically to identify the most salient themes, to explore differences between returning different types of study results, and to describe differences and similarities in perspectives of different stakeholder groups. Results: We found that one size does not fit all when it comes to returning value to participants: the decisions about return of results are affected by participant preferences, researchers' concerns about feasibility, the types of data collected, their level of granularity, and available options for supporting result interpretation. Conclusions: Our findings suggest that the key to operationalizing return of value and to identifying ways to return valuable information to study participants may be to find a point of equilibrium between criteria that may affect usefulness and feasibility. The point of equilibrium may vary by study, by participants' backgrounds and preferences, by their health literacy and access to regular healthcare, and by the resources available to professionals controlling the data. Future studies should explore the factors that determine the point of equilibrium between feasibility and usefulness.

Introduction/objectivesThe engagement of patients and other stakeholders is a critical element in the design of patient-centered outcomes research studies. However, methodology for scalable engagement in research management particularly activities such as operationalization of principles and setting of priorities is not well-developed. The objective of this study is to describe a novel approach for scalable stakeholder engagement in research aligned with the Patient-Centered Outcomes Research Institute (PCORI) engagement principles, which was evaluated in a national clinical data research network.Materials and methodsPatient, patient advocate, clinician, and researcher stakeholders were recruited from clinical sites, as well as social media sites related to the 3 conditions of focus, heart failure, obesity, and Kawasaki disease. The engagement strategy was designed, implemented, and mapped to the PCORI engagement principles. Evaluation included internal assessment and quantitative measures of online engagement.ResultsWe operationalized the PCORI principles with 12 stakeholder engagement strategies and convened stakeholder advisory boards and online research prioritization panels to determine research priorities in a rigorous, deliberative process. A total of 46 advisors (20 patients) and 339 panelists (159 patients) actively participated. There were not significant differences between patients and clinicians in level of online engagement. Nonetheless, while patients reported a slightly greater challenge with following online discussion, they overall had a more favorable opinion about use of the online format.Discussion/conclusionAn efficient way to engage large numbers of representative stakeholders in research is a necessary first step to assure the public of trustworthy use of data networks for health research. This paper describes a comprehensive approach to engagement in patient-centered outcomes research management that informs ongoing development of rigorous methodologies in this area.

ObjectiveDepressed individuals may require help from different agencies to address health and social needs, but how such coordination occurs in under-resourced communities is poorly understood. This study sought to identify priorities of Latino and African American depressed clients, explore whether service providers understand client priorities, and describe how providers address them.MethodsBetween October 2014 and February 2015, we interviewed 104 clients stratified by depression history and 50 representatives of different programs in health and social community agencies who participated in Community Partners in Care, a cluster-randomized trial of coalition-building approaches to delivering depression quality improvement programs. Clients were queried about their most pressing needs; program representatives identified their clients' needs and explained how they addressed them.ResultsPhysical and mental health were clients' top priorities, followed by housing, caring for and building relationships with others, and employment. While persistently depressed clients prioritized mental health, those with improved depression prioritized relationships with others. Program representatives identified housing, employment, mental health, and improving relationships with others as clients' top priorities. Needs assessment, client-centered services, and linkages to other agencies were main strategies used to address client needs.ConclusionDepressed clients have multiple health and social needs, and program representatives in under-resourced communities understand the complexity of clients' needs. Agencies rely on needs assessment and referrals to meet their clients' needs, which enhances the importance of agency partnership in "whole person" initiatives. Our results illustrate agency capacity to adopt integrated care models that will address clients' multiple needs through multi-sector collaboration and describe potential strategies to help reach the goal of whole person care.

ObjectiveThe effectiveness of community coalition building and program technical assistance was compared in implementation of collaborative care for depression among health care and community sector clients.MethodsIn under-resourced communities, within 93 programs randomly assigned to coalition building (Community Engagement and Planning) or program technical assistance (Resources for Services) models, 1,018 clients completed surveys at baseline and at six, 12, or 36 months. Regression analysis was used to estimate intervention effects and intervention-by-sector interaction effects on depression, mental health-related quality of life, and community-prioritized outcomes and on services use.ResultsFor outcomes, there were few significant intervention-by-sector interactions, and stratified findings suggested benefits of coalition building in both sectors. For services use, at 36 months, increases were found for coalition building in primary care visits, self-help visits, and appropriate treatment for community clients and in community-based services use for health care clients.ConclusionsRelative to program technical assistance, community coalition building benefited clients across sectors and shifted long-term utilization across sectors.

ObjectiveCommunity Partners in Care, a community-partnered, cluster-randomized trial with depressed clients from 93 Los Angeles health and community programs, examined the added value of a community coalition approach (Community Engagement and Planning [CEP]) versus individual program technical assistance (Resources for Services [RS]) for implementing depression quality improvement in underserved communities. CEP was more effective than RS in improving mental health-related quality of life, reducing behavioral health hospitalizations, and shifting services toward community-based programs at six months. At 12 months, continued evidence of improvement was found. This study examined three-year outcomes.MethodsAmong 1,004 participants with depression who were eligible for three-year follow-up, 600 participants from 89 programs completed surveys. Multiple regression analyses estimated intervention effects on poor mental health-related quality of life and depression, physical health-related quality of life, behavioral health hospital nights, and use of services.ResultsAt three years, no differences were found in the effects of CEP versus RS on depression or mental health-related quality of life, but CEP had modest effects in improving physical health-related quality of life and reducing behavioral health hospital nights, and CEP participants had more social- and community-sector depression visits and greater use of mood stabilizers. Sensitivity analyses with longitudinal modeling reproduced these findings but found no significant differences between groups in change from baseline to three years.ConclusionsAt three years, CEP and RS did not have differential effects on primary mental health outcomes, but CEP participants had modest improvements in physical health and fewer behavioral health hospital nights.

BackgroundA decade ago, the Institute for Healthcare Improvement pioneered a quality improvement (QI) campaign, leveraging organizational and personal social networks to disseminate new practices. There have been few rigorous studies of the QI campaign approach.MethodsProject JOINTS (Joining Organizations IN Tackling SSIs) engaged a network of state-based organizations and professionals in a 6-month QI campaign promoting adherence to three new evidence-based practices known to reduce the risk of infection after joint replacement. We conducted a cluster-randomized trial including ten states (five campaign states and five non-campaign states) with 188 hospitals providing joint replacement to Medicare. We measured adherence to the evidence-based practices before and after the campaign using a survey of surgical staff and a difference-in-difference design with multivariable adjustment to compare adherence to each of the relevant practices and an all-or-none composite measure of the three new practices.ResultsIn the campaign states, there were statistically significant increases in adherence to the three new evidence-based practices promoted by the campaign. Compared to the non-campaign states, the relative increase in adherence to the three new practices in the campaign states ranged between 1.9 and 15.9 percentage points, but only one of these changes (pre-operative nasal screening for Staphylococcus aureus carriage and decolonization prior to surgery) was statistically significant (p

Following the publication of the original article [1], it was brought to our attention that the title contained an error: "The Institute for Healthcare Improvement's Project JOINTS" was incorrectly included as "the Institute for Health Improvement's Project JOINTS". The title has been corrected to read: "Does a quality improvement campaign accelerate take-up of new evidence? A ten-state cluster-randomized controlled trial of the IHI's Project JOINTS". The corrected title has been included in this erratum and updated in the original article.

ObjectiveLittle evidence exists about effective and scalable methods for meaningful stakeholder engagement in research. We explored patient/caregiver experiences with a high-tech online engagement approach for patient-centered research prioritization, compared their experiences with those of professional stakeholders, and identified factors associated with favorable participant experiences.MethodsWe conducted 8 online modified-Delphi (OMD) panels. Panelists participated in 2 rating rounds with a statistical feedback/online discussion round in between. Panels focused on weight management/obesity, heart failure, and Kawasaki disease. We recruited a convenience sample of adults with any of the 3 conditions (or parents/guardians of Kawasaki disease patients), clinicians, and researchers. Measures included self-reported willingness to use OMD again, the panelists' study participation and online discussion experiences, the system's perceived ease of use, and active engagement metrics.ResultsOut of 349 panelists, 292 (84%) completed the study. Of those, 46% were patients, 36% were clinicians, and 19% were researchers. In multivariate models, patients were not significantly more actively engaged (Odds ratio (OR) = 1.69, 95% confidence interval (CI), 0.94-3.05) but had more favorable study participation (β = 0.49; P  ≤ .05) and online discussion (β = 0.18; P  ≤ .05) experiences and were more willing to use OMD again (β = 0.36; P  ≤ .05), compared to professional stakeholders. Positive perceptions of the OMD system's ease of use (β = 0.16; P  ≤ .05) and favorable study participation (β = 0.26; P  ≤ .05) and online discussion (β = 0.57; P  ≤ .05) experiences were also associated with increased willingness to use OMD in the future. Active engagement was not associated with online experience indices or willingness to use OMD again.ConclusionOnline approaches to engaging large numbers of stakeholders are a promising and efficient adjunct to in-person meetings.

This article describes the patient-centered Scalable National Network for Effectiveness Research (pSCANNER), which is part of the recently formed PCORnet, a national network composed of learning healthcare systems and patient-powered research networks funded by the Patient Centered Outcomes Research Institute (PCORI). It is designed to be a stakeholder-governed federated network that uses a distributed architecture to integrate data from three existing networks covering over 21 million patients in all 50 states: (1) VA Informatics and Computing Infrastructure (VINCI), with data from Veteran Health Administration's 151 inpatient and 909 ambulatory care and community-based outpatient clinics; (2) the University of California Research exchange (UC-ReX) network, with data from UC Davis, Irvine, Los Angeles, San Francisco, and San Diego; and (3) SCANNER, a consortium of UCSD, Tennessee VA, and three federally qualified health systems in the Los Angeles area supplemented with claims and health information exchange data, led by the University of Southern California. Initial use cases will focus on three conditions: (1) congestive heart failure; (2) Kawasaki disease; (3) obesity. Stakeholders, such as patients, clinicians, and health service researchers, will be engaged to prioritize research questions to be answered through the network. We will use a privacy-preserving distributed computation model with synchronous and asynchronous modes. The distributed system will be based on a common data model that allows the construction and evaluation of distributed multivariate models for a variety of statistical analyses.

ObjectiveContinuous quality improvement (CQI) methods are foundational approaches to improving healthcare delivery. Publications using the term CQI, however, are methodologically heterogeneous, and labels other than CQI are used to signify relevant approaches. Standards for identifying the use of CQI based on its key methodological features could enable more effective learning across quality improvement (QI) efforts. The objective was to identify essential methodological features for recognizing CQI.DesignPrevious work with a 12-member international expert panel identified reliably abstracted CQI methodological features. We tested which features met rigorous a priori standards as essential features of CQI using a three-phase online modified-Delphi process.SettingPrimarily United States and Canada.Participants119 QI experts randomly assigned into four on-line panels.InterventionParticipants rated CQI features and discussed their answers using online, anonymous and asynchronous discussion boards. We analyzed ratings quantitatively and discussion threads qualitatively. Main outcome measure(s) Panel consensus on definitional CQI features.Results/st> Seventy-nine (66%) panelists completed the process. Thirty-three completers self-identified as QI researchers, 18 as QI practitioners and 28 as both equally. The features 'systematic data guided activities,' 'designing with local conditions in mind' and 'iterative development and testing' met a priori standards as essential CQI features. Qualitative analyses showed cross-cutting themes focused on differences between QI and CQI.ConclusionsWe found consensus among a broad group of CQI researchers and practitioners on three features as essential for identifying QI work more specifically as 'CQI.' All three features are needed as a minimum standard for recognizing CQI methods.

Active participation of community partners in research aspects of community-academic partnered projects is often assumed to have a positive impact on the outcomes of such projects. The value of community engagement in research, however, cannot be empirically determined without good measures of the level of community participation in research activities. Based on our recent evaluation of community-academic partnered projects centered around behavioral health issues, this article uses semistructured interview and survey data to outline two complementary approaches to measuring the level of community participation in research--a "three-model" approach that differentiates between the levels of community participation and a Community Engagement in Research Index (CERI) that offers a multidimensional view of community engagement in the research process. The primary goal of this article is to present and compare these approaches, discuss their strengths and limitations, summarize the lessons learned, and offer directions for future research. We find that whereas the three-model approach is a simple measure of the perception of community participation in research activities, CERI allows for a more nuanced understanding by capturing multiple aspects of such participation. Although additional research is needed to validate these measures, our study makes a significant contribution by illustrating the complexity of measuring community participation in research and the lack of reliability in simple scores offered by the three-model approach. (Contains 3 tables, 2 figures, and 3 notes.)