Patient, caregiver and other knowledge user engagement in consensus-building healthcare initiatives: a scoping review protocol.

INTRODUCTION: Patient engagement and integrated knowledge translation (iKT) processes improve health outcomes and care experiences through meaningful partnerships in consensus-building initiatives and research. Consensus-building is essential for engaging a diverse group of experienced knowledge users in co-developing and supporting a solution where none readily exists or is less optimal. Patients and caregivers provide invaluable insights for building consensus in decision-making around healthcare, policy and research. However, despite emerging evidence, patient engagement remains sparse within consensus-building initiatives. Specifically, our research has identified a lack of opportunity for youth living with chronic health conditions and their caregivers to participate in developing consensus on indicators/benchmarks for transition into adult care. To bridge this gap and inform our consensus-building approach with youth/caregivers, this scoping review will synthesise the extent of the literature on patient and other knowledge user engagement in consensus-building healthcare initiatives. METHODS AND ANALYSIS: Following the scoping review methodology from Joanna Briggs Institute, published literature will be searched in MEDLINE, EMBASE, CINAHL and PsycINFO databases from inception to July 2023. Grey literature will be hand-searched. Two independent reviewers will determine the eligibility of articles in a two-stage process, with disagreements resolved by a third reviewer. Included studies must be consensus-building studies within the healthcare context that involve patient engagement strategies. Data from eligible studies will be extracted and charted on a standardised form. Abstracted data will be analysed quantitatively and descriptively, according to specific consensus methodologies, and patient engagement models and/or strategies. ETHICS AND DISSEMINATION: Ethics approval is not required for this scoping review protocol. The review process and findings will be shared with and informed by relevant knowledge users. Dissemination of findings will also include peer-reviewed publications and conference presentations. The results will offer new insights for supporting patient engagement in consensus-building healthcare initiatives. PROTOCOL REGISTRATION: https://osf.io/beqjr.

Use of Persuasive Language in Communication of Risk during Prostate Cancer Treatment Consultations.

BACKGROUND: Physician treatment preference may influence how risks are communicated in prostate cancer consultations. We identified persuasive language used when describing cancer prognosis, life expectancy, and side effects in relation to a physician's recommendation for aggressive (surgery/radiation) or nonaggressive (active surveillance/watchful waiting) treatment. METHODS: A qualitative analysis was performed on transcribed treatment consultations of 40 men with low- and intermediate-risk prostate cancer across 10 multidisciplinary providers. Quotes pertaining to cancer prognosis, life expectancy, and side effects were randomized. Coders predicted physician treatment recommendations from isolated blinded quotes. Testing characteristics of consensus predictions against the physician's treatment recommendation were reported. Coders then identified persuasive strategies favoring aggressive/nonaggressive treatment for each quote. Frequencies of persuasive strategies favoring aggressive/nonaggressive treatment were reported. Logistic regression quantified associations between persuasive strategies and physician treatment recommendations. RESULTS: A total of 496 quotes about cancer prognosis (n = 127), life expectancy (n = 51), and side effects (n = 318) were identified. The accuracy of predicting treatment recommendation based on individual quotes containing persuasive language (n = 256/496, 52%) was 91%. When favoring aggressive treatment, persuasive language downplayed side effect risks and amplified cancer risk (recurrence, progression, or mortality). Significant predictors (P < 0.05) of aggressive treatment recommendation included favorable side effect interpretation, downplaying side effects, and long time horizon for cancer risk due to longevity. When favoring nonaggressive treatment, persuasive language amplified side effect risks and downplayed cancer risk. Significant predictors of nonaggressive treatment recommendation included unfavorable side effect interpretation, favorable interpretation of cancer risk, and short time horizon for cancer risk due to longevity. CONCLUSIONS: Physicians use persuasive language favoring their preferred treatment, regardless of whether their recommendation is appropriate. IMPLICATIONS: Clinicians should quantify risk so patients can judge potential harm without solely relying on persuasive language. HIGHLIGHTS: Physicians use persuasive language favoring their treatment recommendation when communicating risks of prostate cancer treatment, which may influence a patient's treatment choice.Coders predicted physician treatment recommendations based on isolated, randomized quotes about cancer prognosis, life expectancy, and side effects with 91% accuracy.Qualitative analysis revealed that when favoring nonaggressive treatment, physicians used persuasive language that amplified side effect risks and downplayed cancer risk. When favoring aggressive treatment, physicians did the opposite.Providers should be cognizant of using persuasive strategies and aim to provide quantified assessments of risk that are jointly interpreted with the patient so that patients can make evidence-based conclusions regarding risks without solely relying on persuasive language.

Variation in communication of side effects in prostate cancer treatment consultations.

BACKGROUND: Effective communication of treatment side effects (SE) is critical for shared decision-making (SDM) in localized prostate cancer. We sought to qualitatively characterize how physicians communicate SE in consultations. METHODS: We transcribed 50 initial prostate cancer treatment consultations across nine multidisciplinary providers (Urologists, Radiation Oncologists, Medical Oncologists) at our tertiary referral, academic center. Coders identified quotes describing SE and used an inductive approach to establish a hierarchy for granularity of communication: (1) not mentioned, (2) name only, (3) generalization("high"), (4) average incidence without timepoint, (5) average incidence with timepoint, and (6) precision estimate. We reported the most granular mode of communication for each SE throughout the consultation overall and across specialty and tumor risk. RESULTS: Among consultations discussing surgery (n = 40), erectile dysfunction (ED) and urinary incontinence (UI) were omitted in 15% and 12%, not quantified (name only or generalization) in 47% and 30%, and noted as average incidence without timeline in 8% and 8%, respectively. In only 30% and 49% were ED and UI quantified with timeline (average incidence with timeline or precision estimate), respectively. Among consultations discussing radiation (n = 36), irritative urinary symptoms, ED, and other post-radiotherapy SE were omitted in 22%, 42%, and 64-67%, not quantified in 61%, 33%, and 23-28%, and noted as average incidence without timeline in 8%, 22%, and 6-8%, respectively. In only 3-8% were post-radiotherapy SE quantified with timeline. Specialty concordance (but not tumor risk) was associated with higher granularity of communication, though physicians frequently failed to quantify specialty-concordant SE. CONCLUSIONS: SE was often omitted, not quantified, and/or lacked a timeline in treatment consultations in our sample. Physicians should articulate, quantify, and assign a timeline for SE to optimize SDM.

Do current pregnancy weight gain guidelines balance risks of adverse maternal and child health in a United States cohort?

BACKGROUND: The Institute of Medicine pregnancy weight gain guidelines were developed without evidence linking high weight gain to maternal cardiometabolic disease and child obesity. The upper limit of current recommendations may be too high for the health of the pregnant individual and child. OBJECTIVES: The aim of this study was to identify the range of pregnancy weight gain for pregnancies within a normal body mass index (BMI) range that balances the risks of high and low weight gain by simultaneously considering 10 different health conditions. METHODS: We used data from an United States prospective cohort study of nulliparae followed until 2 to 7 y postpartum (N = 2344 participants with a normal BMI). Pregnancy weight gain z-score was the main exposure. The outcome was a composite consisting of the occurrence of ≥1 of 10 adverse health conditions that were weighted for their seriousness. We used multivariable Poisson regression to relate weight gain z-scores with the weighted composite outcome. RESULTS: The lowest risk of the composite outcome was at a pregnancy weight gain z-score of -0.6 SD (standard deviation) (equivalent to 13.1 kg at 40 wk). The weight gain ranges associated with no more than 5%, 10%, and 20% increase in risks were -1.0 to -0.2 SD (11.2-15.3 kg), -1.4 to 0 SD (9.4-16.4 kg), and -2.0 to 0.4 SD (7.0-18.9 kg). When we used a lower threshold to define postpartum weight increase in the composite outcome (>5 kg compared with >10 kg), the ranges were 1.6 to -0.7 SD (8.9-12.6 kg), -2.2 to -0.3 SD (6.3-14.7 kg), and ≤0.2 SD (≤17.6 kg). Compared with the ranges of the current weight gain guidelines (-0.9 to -0.1 SD, 11.5-16 kg), the lower limits from our data tended to be lower while upper limits were similar or lower. CONCLUSIONS: If replicated, our results suggest that policy makers should revisit the recommended pregnancy weight gain range for individuals within a normal BMI range.

Expert consensus-based guidance on approaches to opioid management in individuals with advanced cancer-related pain and nonmedical stimulant use.

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 patient's 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.

Disciplinary trends in the use of the Delphi method: A bibliometric analysis.

The Delphi method is an iterative, anonymous, group-based process for eliciting and aggregating opinion on a topic to explore the existence of consensus among experts. The year 2023 marks the 60th anniversary of the first peer-reviewed journal article on the Delphi method. Originally developed for operations research, this method is now applied extensively by researchers representing diverse scientific fields. We used a bibliometric analysis to describe general trends in the expansion of its use across disciplines over time. We conducted a systematic literature search for all English-language, peer-reviewed journal articles on the Delphi method through its first 60 years. We found 19,831 articles: 96.8% (n = 19,204) on the actual use of the Delphi method in an empirical study and 3.2% (n = 627) describing, examining, or providing some guidance on how to use the Delphi method. Almost half (49.9%) of all articles were published in the 2010s and an additional third (32.5%) in the first few years of the 2020s. Nearly two-thirds (65%, n = 12,883) of all published articles have appeared in medical journals, compared to 15% in science and technology (n = 3,053) or social science (n = 3,016) journals. We conclude that the expanded use of the Delphi method has been driven largely by the medical field, though social scientists and technologists continue to be at the forefront of methodological work on the Delphi method. Therefore, we call for greater transdisciplinary collaboration on methodological guidance and standards for the Delphi method.

Consensus-Based Guidance on Opioid Management in Individuals With Advanced Cancer-Related Pain and Opioid Misuse or Use Disorder.

Importance: Opioid misuse and opioid use disorder (OUD) are important comorbidities in people with advanced cancer and cancer-related pain, but there is a lack of consensus on treatment. Objective: To develop consensus among palliative care and addiction specialists on the appropriateness of various opioid management strategies in individuals with advanced cancer-related pain and opioid misuse or OUD. Design, Setting, and Participants: For this qualitative study, using ExpertLens, an online platform and methodology for conducting modified Delphi panels, between August and October 2020, we conducted 2 modified Delphi panels to understand the perspectives of palliative and addiction clinicians on 3 common clinical scenarios varying by prognosis (weeks to months vs months to years). Of the 129 invited palliative or addiction medicine specialists, 120 participated in at least 1 round. A total of 84 participated in all 3 rounds. Main Outcomes and Measures: Consensus was investigated for 3 clinical scenarios: (1) a patient with a history of an untreated opioid use disorder, (2) a patient taking more opioid than prescribed, and (3) a patient using nonprescribed benzodiazepines. Results: Participants were mostly women (47 [62%]), White (94 (78 [65%]), and held MD/DO degrees (115 [96%]). For a patient with untreated OUD, regardless of prognosis, it was deemed appropriate to begin treatment with buprenorphine/naloxone and inappropriate to refer to a methadone clinic. Beginning split-dose methadone was deemed appropriate for patients with shorter prognoses and of uncertain appropriateness for those with longer prognoses. Beginning a full opioid agonist was deemed of uncertain appropriateness for those with a short prognosis and inappropriate for those with a longer prognosis. Regardless of prognosis, for a patient with no medical history of OUD taking more opioids than prescribed, it was deemed appropriate to increase monitoring, inappropriate to taper opioids, and of uncertain appropriateness to increase the patient's opioids or transition to buprenorphine/naloxone. For a patient with a urine drug test positive for non-prescribed benzodiazepines, regardless of prognosis, it was deemed appropriate to increase monitoring, inappropriate to taper opioids and prescribe buprenorphine/naloxone. Conclusions and Relevance: The findings of this qualitative study provide urgently needed consensus-based guidance for clinicians and highlight critical research and policy gaps.

Variation in Communication of Competing Risks of Mortality in Prostate Cancer Treatment Consultations.

PURPOSE: Men with prostate cancer prefer patient-specific, quantitative assessments of longevity in shared decision making. We sought to characterize how physicians communicate the 3 components of competing risks-life expectancy (LE), cancer prognosis and treatment-related survival benefit-in treatment consultations. MATERIALS AND METHODS: Conversation related to LE, cancer prognosis and treatment-related survival benefit was identified in transcripts from treatment consultations of 42 men with low- and intermediate-risk disease across 10 multidisciplinary providers. Consensus of qualitative coding by multiple reviewers noted the most detailed mode of communication used to describe each throughout the consultation. RESULTS: Physicians frequently failed to provide patient-specific, quantitative estimates of LE and cancer mortality. LE was omitted in 17% of consultations, expressed as a generalization (eg "long"/"short") in 17%, rough number of years in 31%, probability of mortality/survival at an arbitrary timepoint in 17% and in only 19% as a specific number of years. Cancer mortality was omitted in 24% of consultations, expressed as a generalization in 7%, years of expected life in 2%, probability at no/arbitrary timepoint in 40% and in only 26% as the probability at LE. Treatment-related survival benefit was often omitted; cancer mortality was reported without treatment in 38%, with treatment in 10% and in only 29% both with and without treatment. Physicians achieved "trifecta"-1) quantifying probability of cancer mortality 2) with and without treatment 3) at the patient's LE-in only 14% of consultations. CONCLUSIONS: Physicians often fail to adequately quantify competing risks. We recommend the "trifecta" approach, reporting 1) probability of cancer mortality 2) with and without treatment 3) at the patient's LE.

The Effect of the Medicare Advantage Value-Based Insurance Design Model Test on Utilization in 2017.

In 2015, the Centers for Medicare and Medicaid Services announced the Medicare Advantage (MA) Value-Based Insurance Design (VBID) model test, which allows MA insurers to use flexible benefit design strategies, such as reduced cost-sharing, to encourage beneficiaries with chronic disease to use high-value care. During the first year of implementation (2017), nine MA insurers offered VBID in 45 health plans to a total of 96 053 eligible beneficiaries. We used MA encounter data to estimate the impact of VBID on health services utilization in 2017 using a difference-in-differences research design. We found that VBID increased use of 10 out of 18 targeted services, and led to general increases in primary care visits, specialty care visits, and drug fills across eligible beneficiaries. The model was also associated with increases in ambulatory care sensitive inpatient and emergency department visits, an unanticipated effect that may be temporary. Overall, our findings suggest that VBID successfully increased the use of high-value services among eligible MA beneficiaries, an important first step along the pathway to better chronic disease management, lower spending, and improved beneficiary health.

Development of a Metric to Detect and Decrease Low-Value Prescribing in Older Adults.

Importance: Metrics that detect low-value care in common forms of health care data, such as administrative claims or electronic health records, primarily focus on tests and procedures but not on medications, representing a major gap in the ability to systematically measure low-value prescribing. Objective: To develop a scalable and broadly applicable metric that contains a set of quality indicators (EVOLV-Rx) for use in health care data to detect and reduce low-value prescribing among older adults and that is informed by diverse stakeholders' perspectives. Design, Setting, and Participants: This qualitative study used an online modified-Delphi method to convene an expert panel of 15 physicians and pharmacists. This panel, comprising clinicians, health system leaders, and researchers, was tasked with rating and discussing candidate low-value prescribing practices that were derived from medication safety criteria; peer-reviewed literature; and qualitative studies of patient, caregiver, and physician perspectives. The RAND ExpertLens online platform was used to conduct the activities of the panel. The panelists were engaged for 3 rounds between January 1 and March 31, 2021. Main Outcomes and Measures: Panelists used a 9-point Likert scale to rate and then discuss the scientific validity and clinical usefulness of the criteria to detect low-value prescribing practices. Candidate low-value prescribing practices were rated as follows: 1 to 3, indicating low validity or usefulness; 3.5 to 6, uncertain validity or usefulness; and 6.5 to 9, high validity or usefulness. Agreement among panelists and the degree of scientific validity and clinical usefulness were assessed using the RAND/UCLA (University of California, Los Angeles) Appropriateness Method. Results: Of the 527 low-value prescribing recommendations identified, 27 discrete candidate low-value prescribing practices were considered for inclusion in EVOLV-Rx. After round 1, 18 candidate practices were rated by the panel as having high scientific validity and clinical usefulness (scores of ≥6.5). After round 2 panel deliberations, the criteria to detect 19 candidate practices were revised. After round 3, 18 candidate practices met the inclusion criteria, receiving final median scores of 6.5 or higher for both scientific validity and clinical usefulness. Of those practices that were not included in the final version of EVOLV-Rx, 3 received high scientific validity (scores ≥6.5) but uncertain clinical usefulness (scores <6.5) ratings, whereas 6 received uncertain scientific validity rating (scores <6.5). Conclusions and Relevance: This study culminated in the development of EVOLV-Rx and involved a panel of experts who identified the 18 most salient low-value prescribing practices in the care of older adults. Applying EVOLV-Rx may enhance the detection of low-value prescribing practices, reduce polypharmacy, and enable older adults to receive high-value care across the full spectrum of health services.

The impact of panel composition and topic on stakeholder perspectives: Generating hypotheses from online maternal and child health modified-Delphi panels.

INTRODUCTION: Multistakeholder engagement is crucial for conducting health services research. Delphi-based methodologies combining iterative rounds of questions with feedback on and discussion of group results are a well-documented approach to multistakeholder engagement. This study develops hypotheses about the impact of panel composition and topic on the propensity and meaningfulness of response changes in multistakeholder modified-Delphi panels. METHODS: We conducted three online modified-Delphi (OMD) multistakeholder panels using the same protocol. We assigned 60 maternal and child health professionals to a homogeneous (professionals only) panel, 60 pregnant or postpartum women (patients) to a homogeneous panel, and 30 professionals and 30 patients to a mixed panel. In Round 1, participants rated the seriousness of 11 maternal and child health outcomes using a 0-100 scale and explained their ratings. In Round 2, participants saw their own and their panel's Round 1 results and discussed them using asynchronous, anonymous discussion boards moderated by the study investigators. In Round 3, participants revised their original ratings. Our outcome measures included binary indicators of response changes to ratings of the low, medium and high severity maternal and child health outcomes and their meaningfulness, measured by a change of 10 or more points. RESULTS: Participants changed 818 of 1491 (55%) of responses; the majority of response changes were meaningful. Patterns of response changes were different for patients and professionals and for different levels of outcome seriousness. Using study results and the literature, we developed three hypotheses. First, OMD participants, regardless of their stakeholder group, are more likely to change their responses on preference-sensitive topics where there is a range of viable alternatives or perspectives. Second, patients are more likely to change their responses and to do so meaningfully in mixed panels, whereas professionals are more likely to do so in homogeneous panels. Third, the association between panel composition and response change varies according to the topic (e.g., the level of outcome seriousness). CONCLUSIONS: Results of our work not only helped generate empirically derived hypotheses to be tested in future research but also offer practical recommendations for designing multistakeholder OMD panels. PATIENT OR PUBLIC CONTRIBUTION: Pregnant or postpartum women were involved in this study.

Improving Mental Health Guardianship: From Prevention to Treatment.

OBJECTIVE: The authors sought to identify the most promising strategies for improving the mental health guardianship process in Los Angeles County for adults with mental illness who are gravely disabled. METHODS: In May and June 2019, 56 experts, working in hospitals or outpatient facilities or representing legal, advocacy, policy, or forensic organizations, participated in an online modified-Delphi panel, rating the ethical appropriateness, impact on care quality, efficiency, and feasibility of nine strategies for improvement of mental health guardianship. Agreement was determined with the RAND/UCLA appropriateness method, and comments were thematically analyzed. RESULTS: The strategy ranked highest by the participating experts was improving the administrative functioning and judicial processes of entities involved in mental health guardianship proceedings-it was the only strategy that achieved agreement among panelists and was rated highly on all four criteria. Other preferred strategies were enhancing the ability of assertive outpatient mental health teams to serve individuals before they experience a crisis and expanding the continuum of unlocked residential treatment settings. CONCLUSIONS: Opportunities exist to improve all stages of the mental health guardianship process. Experts favored strategies that streamline administrative processes, facilitate community integration into treatment, and ensure fidelity to best practices. Improving the mental health guardianship process has the potential to speed up delivery of services, better manage resources, and increase access to treatment for individuals with mental illness who are gravely disabled.

Standardizing the Clinical Definition of Opioid Withdrawal in the Neonate.

OBJECTIVE: To standardize the clinical definition of opioid withdrawal in neonates to address challenges in clinical care, quality improvement, research, and public policy for this patient population. STUDY DESIGN: Between October and December 2020, we conducted 2 modified-Delphi panels using ExpertLens, a virtual platform for performing iterative expert engagement panels. Twenty clinical experts specializing in care for the substance-exposed mother-neonate dyad explored the necessity of key evidence-based clinical elements in defining opioid withdrawal in the neonate leading to a diagnosis of neonatal abstinence syndrome (NAS)/neonatal opioid withdrawal syndrome (NOWS). Expert consensus was assessed using descriptive statistics, the RAND/UCLA Appropriateness Method, and thematic analysis of participants' comments. RESULTS: Expert panels concluded the following were required for diagnosis: in utero exposure (known by history, not necessarily by toxicology testing) to opioids with or without the presence of other psychotropic substances, and the presence of at least two of the most common clinical signs characteristic of withdrawal (excessive crying, fragmented sleep, tremors, increased muscle tone, gastrointestinal dysfunction). CONCLUSIONS: Results indicate that both a known history of in utero opioid exposure and a distinct set of withdrawal signs are necessary to standardize a definition of neonatal withdrawal. Implementation of a standardized definition requires both patient engagement and a mother-neonate dyadic approach mindful of program and policy implications.

Expert Panel Consensus on Management of Advanced Cancer-Related Pain in Individuals With Opioid Use Disorder.

Importance: Opioid use disorder (OUD) is an important comorbidity in individuals with advanced cancer, in whom pain is common. Full-agonist opioid medications are the cornerstone of cancer pain management, but the existing literature does not address how to manage cancer pain in patients with OUD. Objective: To conduct an expert panel to develop consensus on the appropriateness of management of cancer pain in individuals with co-occurring advanced cancer and OUD. Evidence Review: A 3-round modified Delphi process was completed from August to October 2020 with 2 cases: patient with advanced cancer, pain, and OUD treated with buprenorphine-naloxone or methadone. Participants rated management strategies in round 1, discussed results in round 2, and provided final responses in round 3. ExpertLens, an online approach to conducting modified Delphi panels, was used. Participants were experts in palliative care, addiction, or both, recruited by email from palliative care and addiction-focused professional groups, lists from prior studies, and snowball sampling. Data analysis was performed from November 2020 to July 2021. Findings: Of 120 experts (median age, 40-49 years), most were White (78 participants [94%]), female (74 participants [62%]), and held MD or DO degrees (115 participants [96%]); 84 (70%) participated in all rounds. For a patient with OUD taking buprenorphine-naloxone, it was deemed appropriate to continue buprenorphine-naloxone with thrice-daily dosing. Continuing buprenorphine-naloxone and adding a full-agonist opioid was deemed to be appropriate for patients with a prognosis of weeks to months and of uncertain appropriateness for patients with a prognosis of months to years. For a patient with OUD taking methadone dispensed at a methadone clinic, it was deemed appropriate to take over prescribing and dose twice or thrice daily. Continuing methadone daily while adding another full-agonist opioid was deemed appropriate for patients with a prognosis of weeks to months and of uncertain appropriateness for those with a prognosis of months to years. Conclusions and Relevance: The findings of this qualitative study provide urgently needed, consensus-based guidance for clinicians and highlight critical research and policy gaps needed to facilitate implementation.

Informing the Development of a Standardized Clinical Definition of Neonatal Abstinence Syndrome: Protocol for a Modified-Delphi Expert Panel.

BACKGROUND: Neonatal abstinence syndrome (NAS) is a postnatal withdrawal syndrome that most commonly results from prenatal opioid exposure. Every 15 minutes, an infant is born in the United States with signs of NAS. The field lacks a standardized clinical definition of NAS, complicating discussions on programmatic and policy development to support opioid-exposed mothers and infants. OBJECTIVE: The goal of this paper is to describe a protocol for a systematic expert panel process to inform the development of a clinical definition of NAS. METHODS: We will conduct two three-round online modified-Delphi panels using the ExpertLens system and will follow the recommendations for Conducting and REporting of DElphi Studies (CREDES). One panel will focus on developing key components of a clinical definition of NAS, and the second panel will focus on neonatal opioid withdrawal syndrome (NOWS), which is a term that has come into use to differentiate opioid-exposed infants from infants exposed to other substances in utero. However, there is lack of agreement on the precise clinical definition of NOWS and how it is distinct from or overlaps with NAS. Each panel will complete two rating rounds and a discussion round using a similar protocol. We will analyze all rating data descriptively and determine the presence of agreement within and between the two panels. We will also perform thematic analysis of the qualitative comments to contextualize the panel findings. RESULTS: The panels were convened between October 29 and December 17, 2020. Their results were disseminated and discussed at a national conference on NAS that took place on March 17-18, 2021. CONCLUSIONS: A standardized clinical definition of NAS will help to better characterize NAS incidence and to design effective clinical, public health, and policy interventions to support opioid-exposed mother-infant dyads. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25387.

Alignment Between Objective and Subjective Assessments of Health System Performance: Findings From a Mixed-Methods Study.

EXECUTIVE SUMMARY: The article examines whether subjective performance assessments from health system executives match objective performance assessments and qualitatively explores ways to achieve high performance. We interviewed 138 C-suite executives of 24 health systems in California, Minnesota, Washington, and Wisconsin between 2017 and 2019. We used maximum variation sampling to select health systems to achieve diversity in performance on objective measures of clinical performance. Our interviews focused on executives' perceptions of their own health system's performance and factors they thought generally contributed to high performance. In our analysis, we grouped health systems based on objective performance levels (high, medium, and low) used in sampling, compared objective performance ratings with executives' subjective performance assessments, and used thematic analysis to identify reasons for subjective assessment of health system performance and levers of high performance in general. There was poor agreement between objective and subjective performance assessments (kappa = 0.082). Subjective assessments were higher than objective assessments and captured more factors than are typically considered in performance accountability and value-based payment initiatives. Executives whose views were inconsistent with objective performance assessments did not cite clinical care quality per se as the basis for their assessment, focusing instead on market competition, financial performance, and high customer satisfaction and loyalty. Executives who cited clinical quality metrics as the basis of their assessment offered subjective ratings consistent with objective ratings. Executives identified organizational culture, organizational governance, and staff engagement as levers for achieving high performance. Future research should explore the benefits and drawbacks of considering subjective performance assessments in value-based payment initiatives.

Consensus-based approach to managing opioids, including opioid misuse and opioid use disorder, in patients with serious illness: protocol for a modified Delphi process.

INTRODUCTION: Management 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 ANALYSIS: We 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 DISSEMINATION: This 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.