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.

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.

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.

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.

Rating the seriousness of maternal and child health outcomes linked with pregnancy weight gain.

BACKGROUND: Current pregnancy weight gain guidelines were developed based on implicit assumptions of a small group of experts about the relative seriousness of adverse health outcomes. Therefore, they will not necessarily reflect the values of women. OBJECTIVE: To estimate the seriousness of 11 maternal and child health outcomes that have been consistently associated with pregnancy weight gain by engaging patients and health professionals. METHODS: We collected data using an online panel approach with a modified Delphi structure. We selected a purposeful sample of maternal and child health professionals (n = 84) and women who were pregnant or recently postpartum (patients) (n = 82) in the United States as panellists. We conducted three concurrent panels: professionals only, patients only, and patients and professionals. During a 3-round online modified Delphi process, participants rated the seriousness of health outcomes (Round 1), reviewed and discussed the initial results (Round 2), and revised their original ratings (Round 3). Panellists assigned seriousness ratings (0, [not serious] to 100 [most serious]) for infant death, stillbirth, preterm birth, gestational diabetes, preeclampsia, small-for-gestational-age (SGA) birth, large-for-gestational-age (LGA) birth, unplanned caesarean delivery, maternal obesity, childhood obesity, and maternal metabolic syndrome. RESULTS: Each panel individually came to a consensus on all seriousness ratings. The final median seriousness ratings combined across all panels were highest for infant death (100), stillbirth (95), preterm birth (80), and preeclampsia (80). Obesity in children, metabolic syndrome in women, obesity in women, and gestational diabetes had median seriousness ratings ranging from 55 to 65. The lowest seriousness ratings were for SGA birth, LGA birth, and unplanned caesarean delivery (30-40). CONCLUSION: Professionals and women rate some adverse outcomes as being more serious than others. These ratings can be used to establish the range of pregnancy weight gain associated with the lowest risk of a broad range of maternal and child health outcomes.

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.

Nature and Predictors of Response Changes in Modified-Delphi Panels.

OBJECTIVES: To describe the extent and nature of changes in participants' responses after exposure to group feedback and discussion in modified-Delphi panels and to identify factors affecting those changes. METHODS: We analyzed data from 2 online modified-Delphi panels, each consisting of 2 rating rounds and an online discussion round. We included responses from 55 participants who answered 38 questions in both rating rounds. Because not all participants answered each question twice, our sample consisted of 1846 cases (response changes). We used mixed-effect logistic and multinomial logistic regression to identify factors predicting response changes and their direction relative to group median-our consensus measure. RESULTS: Participants changed, on average, 49% of their responses. A response was changed in 47% of the 1846 cases: 28% of responses were changed toward consensus and 19% away from it. Although some measures of subjective participation experiences had a marginally significant impact on the propensity and direction of response changes, several objective measures of discussion engagement were statistically significant predictors of both the presence and direction of response changes. CONCLUSION: Our results illustrate the nature of response changes and highlight the importance of exposing participants to alternative perspectives and encouraging them to explain their perspectives.

A Novel Stakeholder Engagement Approach for Patient-centered Outcomes Research.

INTRODUCTION/OBJECTIVES: The 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 METHODS: Patient, 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. RESULTS: We 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/CONCLUSION: An 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.

Whole Person Care in Under-resourced Communities: Stakeholder Priorities at Long-Term Follow-Up in Community Partners in Care.

Objective: Depressed 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. Methods: Between 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. Results: Physical 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. Conclusion: Depressed 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.

Patient engagement in the process of planning and designing outpatient care improvements at the Veterans Administration Health-care System: findings from an online expert panel.

CONTEXT: There is a strong interest in the Veterans Administration (VA) Health-care System in promoting patient engagement to improve patient care. METHODS: We solicited expert opinion using an online expert panel system with a modified Delphi structure called ExpertLens™ . Experts reviewed, rated and discussed eight scenarios, representing four patient engagement roles in designing and improving VA outpatient care (consultant, implementation advisor, equal stakeholder and lead stakeholder) and two VA levels (local and regional). Rating criteria included desirability, feasibility, patient ability, physician/staff acceptance and impact on patient-centredness and care quality. Data were analysed using the RAND/UCLA Appropriateness Method for determining consensus. FINDINGS: Experts rated consulting with patients at the local level as the most desirable and feasible patient engagement approach. Engagement at the local level was considered more desirable than engagement at the regional level. Being an equal stakeholder at the local level received the highest ratings on the patient-centredness and health-care quality criteria. CONCLUSIONS: Our findings illustrate expert opinion about different approaches to patient engagement and highlight the benefits and challenges posed by each. Although experts rated local consultations with patients on an as-needed basis as most desirable and feasible, they rated being an equal stakeholder at the local level as having the highest potential impact on patient-centredness and care quality. This result highlights a perceived discrepancy between what is most desirable and what is potentially most effective, but suggests that routine local engagement of patients as equal stakeholders may be a desirable first step for promoting high-quality, patient-centred care.

Collaborative learning framework for online stakeholder engagement.

BACKGROUND: Public and stakeholder engagement can improve the quality of both research and policy decision making. However, such engagement poses significant methodological challenges in terms of collecting and analysing input from large, diverse groups. OBJECTIVE: To explain how online approaches can facilitate iterative stakeholder engagement, to describe how input from large and diverse stakeholder groups can be analysed and to propose a collaborative learning framework (CLF) to interpret stakeholder engagement results. METHODS: We use 'A National Conversation on Reducing the Burden of Suicide in the United States' as a case study of online stakeholder engagement and employ a Bayesian data modelling approach to develop a CLF. RESULTS: Our data modelling results identified six distinct stakeholder clusters that varied in the degree of individual articulation and group agreement and exhibited one of the three learning styles: learning towards consensus, learning by contrast and groupthink. Learning by contrast was the most common, or dominant, learning style in this study. CONCLUSION: Study results were used to develop a CLF, which helps explore multitude of stakeholder perspectives; identifies clusters of participants with similar shifts in beliefs; offers an empirically derived indicator of engagement quality; and helps determine the dominant learning style. The ability to detect learning by contrast helps illustrate differences in stakeholder perspectives, which may help policymakers, including Patient-Centered Outcomes Research Institute, make better decisions by soliciting and incorporating input from patients, caregivers, health-care providers and researchers. Study results have important implications for soliciting and incorporating input from stakeholders with different interests and perspectives.

From subject to participant: ethics and the evolving role of community in health research.

Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research.

JOURNAL CLUB: Radiologists' Perceptions of Computerized Decision Support: A Focus Group Study From the Medicare Imaging Demonstration Project.

OBJECTIVE: The purpose of this study was to discern radiologists' perceptions regarding the implementation of a decision support system intervention as part of the Medicare Imaging Demonstration project and the effect of decision support on radiologists' interactions with ordering clinicians, their radiology work flow, and appropriateness of advanced imaging. SUBJECTS AND METHODS: A focus group study was conducted with a diverse sample of radiologists involved in interpreting advanced imaging studies at Medicare Imaging Demonstration project sites. A semistructured moderator guide was used, and all focus group discussions were recorded and transcribed verbatim. Qualitative data analysis software was used to code thematic content and identify representative segments of text. Participating radiologists also completed an accompanying survey designed to supplement focus group discussions. RESULTS: Twenty-six radiologists participated in four focus group discussions. The following major themes related to the radiologists' perceptions after decision support implementation were identified: no substantial change in radiologists' interactions with referring clinicians; no substantial change in radiologist work flow, including protocol-writing time; and no perceived increase in imaging appropriateness. Radiologists provided suggestions for improvements in the decision support system, including increasing the usability of clinical data captured, and expressed a desire to have greater involvement in future development and implementation efforts. CONCLUSION: Overall, radiologists from health care systems involved in the Medicare Imaging Demonstration did not perceive that decision support had a substantial effect, either positive or negative, on their professional roles and responsibilities. Radiologists expressed a desire to improve efficiencies and quality of care by having greater involvement in future efforts.

How can we recognize continuous quality improvement?

OBJECTIVE: Continuous 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. DESIGN: Previous 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. SETTING: Primarily United States and Canada. PARTICIPANTS: 119 QI experts randomly assigned into four on-line panels. INTERVENTION: Participants 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. CONCLUSIONS: We 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.

An implementation evaluation of the community engagement and planning intervention in the CPIC Depression Care Improvement Trial.

The goal of this paper is to document and evaluate the process of implementing an evidence-based depression intervention in community settings through the use of community-academic partnered approaches. We discuss how and to what extent the goals of community engagement and collaborative planning were achieved in the intervention arm of the Community Partners in Care study that aimed to adapt evidence-based depression care toolkits for diverse agencies in Hollywood and South Los Angeles. We find that partnered research strategies have a potential to effectively engage community members around depression and involve them in intervention planning activities. Our results suggest that successful collaboration among diverse agencies requires that they understand what is expected of them, are comfortable with the role they choose to perform, and have organizational support to contribute to the project. To facilitate the development of collaborative relationships, time and effort should be devoted to explaining how collaboration among diverse agencies may take place.

Assessing the feasibility and likelihood of policy options to lower specialty drug costs.

Specialty drugs are high-cost medications often used to treat complex chronic conditions. Even with insurance coverage, patients may face very high out-of-pocket costs, which in turn may restrict access. While the Inflation Reduction Act of 2022 included policies designed to reduce specialty drug costs, relatively few policies have been enacted during the past decade. In 2022-2023, we conducted a scoping literature review to identify a range of policy options and selected a set of 9 that have been regularly discussed or recently considered to present to an expert stakeholder panel to seek consensus on (1) the feasibility of implementing each policy and (2) its likely impact on drug costs. Experts rated only 1 policy highly on both feasibility and impact: grouping originator biologics and biosimilars under the same Medicare Part B reimbursement code. They rated 3 policies focused on setting payment limits as likely to have positive (downward) impact on costs but of uncertain feasibility. They considered 4 policies as uncertain on both criteria. Experts rated capping monthly out-of-pocket costs as feasible but unlikely to reduce specialty drug costs. Based on these results, we offer 4 recommendations to policymakers considering ways to reduce specialty drug costs.

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.

Gestational weight gain below recommendations and adverse maternal and child health outcomes for pregnancies with overweight or obesity: a United States cohort study.

BACKGROUND: The current Institute of Medicine (IOM) pregnancy weight gain guidelines were developed using the best available evidence but were limited by substantial knowledge gaps. Some have raised concern that the guidelines for individuals affected by overweight or obesity are too high and contribute to short- and long-term complications for the mother and child. OBJECTIVES: To determine the association between pregnancy weight gain below the lower limit of the current IOM recommendations and risk of 10 adverse maternal and child health outcomes among individuals with overweight and obesity. METHODS: We used data from a prospective cohort study of United States nulliparae with prepregnancy overweight (n = 955) or obesity (n = 897) followed from the first trimester to 2-7 y postpartum. We used multivariable Poisson regression to relate pregnancy weight gain z-scores with a severity-weighted composite outcome consisting of ≥1 of 10 adverse outcomes (gestational diabetes, preeclampsia, unplanned cesarean delivery, maternal postpartum weight increase >10 kg, maternal postpartum metabolic syndrome, infant death, stillbirth, preterm birth, small-for-gestational age birth, and childhood obesity). RESULTS: Pregnancy weight gain z-scores below, within, and above the IOM-recommended ranges occurred in 5%, 13%, and 80% of pregnancies with overweight and 17%, 13%, and 70% of pregnancies with obesity. There was a positive association between pregnancy weight gain z-scores and all adverse maternal outcomes, childhood obesity, and the composite outcome. Pregnancy weight gain z-scores below the lower limit of the recommended ranges (<6.8 kg for overweight, <5 kg for obesity) were not associated with the severity-weighted composite outcome. For example, compared with the lower limit, adjusted rate ratios (95% confidence interval) for z-scores of -2 standard deviations in pregnancies with overweight (equivalent to 3.6 kg at 40 wk) and obesity (-2.8 kg at 40 wk) were 0.99 (95% confidence interval [CI]: 0.91, 1.06) and 0.97 (95% CI: 0.87, 1.07). CONCLUSIONS: These findings support arguments to decrease the lower limit of recommended weight gain ranges in these prepregnancy body mass index groups.

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.