Abnormal uterine bleeding diagnoses and care following COVID-19 vaccination.

BACKGROUND: There is evidence suggesting that COVID-19 vaccination may be associated with small, transitory effects on uterine bleeding, possibly including menstrual timing, flow, and duration, in some individuals. However, changes in health care seeking, diagnosis, and workup for abnormal uterine bleeding in the COVID-19 vaccine era are less clear. OBJECTIVE: This study aimed to assess the impact of COVID-19 vaccination on incident abnormal uterine bleeding diagnosis and diagnostic evaluation in a large integrated health system. STUDY DESIGN: Using segmented regression, we assessed whether the availability of COVID-19 vaccines was associated with changes in monthly, population-based rates of incident abnormal uterine bleeding diagnoses relative to the prepandemic period in health system members aged 16 to 44 years who were not menopausal. We also compared clinical and demographic characteristics of patients diagnosed with incident abnormal uterine bleeding between December 2020 and October 13, 2021 by vaccination status (never vaccinated, vaccinated in the 60 days before diagnosis, vaccinated >60 days before diagnosis). Furthermore, we conducted detailed chart review of patients diagnosed with abnormal uterine bleeding within 1 to 60 days of COVID-19 vaccination in the same time period. RESULTS: In monthly populations ranging from 79,000 to 85,000 female health system members, incidence of abnormal uterine bleeding diagnosis per 100,000 person-days ranged from 8.97 to 19.19. There was no significant change in the level or trend in the incidence of abnormal uterine bleeding diagnoses between the prepandemic (January 2019-January 2020) and post-COVID-19 vaccine (December 2020-December 2021) periods. A comparison of clinical characteristics of 2717 abnormal uterine bleeding cases by vaccination status suggested that abnormal bleeding among recently vaccinated patients was similar or less severe than abnormal bleeding among patients who had never been vaccinated or those vaccinated >60 days before. There were also significant differences in age and race of patients with incident abnormal uterine bleeding diagnoses by vaccination status (Ps<.02). Never-vaccinated patients were the youngest and those vaccinated >60 days before were the oldest. The proportion of patients who were Black/African American was highest among never-vaccinated patients, and the proportion of Asian patients was higher among vaccinated patients. Chart review of 114 confirmed postvaccination abnormal uterine bleeding cases diagnosed from December 2020 through October 13, 2021 found that the most common symptoms reported were changes in timing, duration, and volume of bleeding. Approximately one-third of cases received no diagnostic workup; 57% had no etiology for the bleeding documented in the electronic health record. In 12% of cases, the patient mentioned or asked about a possible link between their bleeding and their recent COVID-19 vaccine. CONCLUSION: The availability of COVID-19 vaccination was not associated with a change in incidence of medically attended abnormal uterine bleeding in our population of over 79,000 female patients of reproductive age. In addition, among 2717 patients with abnormal uterine bleeding diagnoses in the period following COVID-19 vaccine availability, receipt of the vaccine was not associated with greater bleeding severity.

Resident training to optimize patient-focused menopause management: a multispecialty menopause curriculum to enhance knowledge and preparedness.

OBJECTIVE: Surveys of residents in obstetrics and gynecology, internal medicine, and family medicine have demonstrated low levels of knowledge and comfort in treating patients with menopausal symptoms, suggesting a need for improved training during residency. To address this problem, we used a flipped classroom design to deliver a novel menopause curriculum for medical residents. The curriculum included six podcast episodes followed by an interactive case-based classroom session. We then assessed effects of the curriculum on the residents' knowledge and preparedness to manage menopause symptoms. METHODS: We targeted 200 residents (43 obstetrics and gynecology, 86 internal medicine, and 71 family medicine) from six residency programs from 2019 to 2020. Of these, 115 (58%) completed both pre- and postcurriculum assessments, including a 15-item knowledge test and self-ratings of their knowledge, comfort, and preparedness to manage menopause. RESULTS: Following the curriculum, the proportion of correctly answered knowledge questions rose from 60.8% to 79.1% (+18.3%; 95% confidence interval, 15.4-21.2; Cohen's d = 1.2). Improvement did not significantly differ by specialty or year of residency. There were higher gains for residents who listened to the entirety of all six podcast episodes ( b = 11.4, P < 0.001) and who attended the classroom session ( b = 11.6, P = 0.003). Residents' self-ratings of knowledge, comfort, and preparedness also improved following the curriculum across all medical specialties (Cohen's d = 0.47-1.2). Residents rated the podcast format as convenient (73%) and effective (65%) compared with an equivalent amount of reading. CONCLUSIONS: Pairing a podcast with a classroom discussion was found to be an effective combination for improving menopause knowledge.

Incidence of Adolescent Syncope and Related Injuries Following Vaccination and Routine Venipuncture.

PURPOSE: Vaccination is associated with syncope in adolescents. However, incidence of vaccine-associated syncope and resulting injury, and how it compares to syncope incidence following other medical procedures, is not known. Here, we describe the incidence of syncope and syncope-related injury in adolescents following vaccination and routine venipuncture. METHODS: We identified all Kaiser Permanente Northwest members ages 9-18 years with a vaccination or routine venipuncture and a same-day International Classification of Diseases diagnosis of syncope from 2013 through 2019. All cases were chart reviewed to establish chronology of events (vaccination, venipuncture, syncope, and injury, as applicable) and to attribute cause to vaccination or venipuncture. Incidence rates for vaccine-associated and venipuncture-associated syncope were calculated overall, by sex and age group. Syncope events resulting in injury were assessed for each event type. RESULTS: Of 197,642 vaccination and 12,246 venipuncture events identified, 549 vaccination and 67 venipuncture events had same-day syncope codes. Chart validation confirmed 59/549 (10.7%) events as vaccine-associated syncope, for a rate of 2.99 per 10,000 vaccination events (95% confidence interval (CI): 2.27-3.85) and 20/67 (29.9%) events as venipuncture-associated syncope, for a rate of 16.33 per 10,000 venipuncture events (95% CI: 9.98-25.21). The incidence rate ratio of vaccine-associated to venipuncture-associated syncope events was 0.18 (95% CI: 0.11-0.31). The incidence of vaccine-associated syncope increased with each additional simultaneously administered vaccine, from 1.51 per 10,000 vaccination events (95% CI: 0.93-2.30) following a single vaccine to 9.94 per 10,000 vaccination events (95% CI: 6.43-14.67) following three or more vaccines. Syncope resulted in injury in about 15% of both vaccine and venipuncture events. DISCUSSION: Syncope occurs more commonly following venipuncture than vaccination. The number of simultaneously administered vaccines is a risk factor for postvaccination syncope in adolescents.

Postmenopausal bleeding after COVID-19 vaccination.

BACKGROUND: There is a growing literature base regarding menstrual changes following COVID-19 vaccination among premenopausal people. However, relatively little is known about uterine bleeding in postmenopausal people following COVID-19 vaccination. OBJECTIVE: This study aimed to examine trends in incident postmenopausal bleeding diagnoses over time before and after COVID-19 vaccine introduction, and to describe cases of new-onset postmenopausal bleeding after COVID-19 vaccination. STUDY DESIGN: For postmenopausal bleeding incidence calculations, monthly population-level cohorts consisted of female Kaiser Permanente Northwest members aged ≥45 years. Those diagnosed with incident postmenopausal bleeding in the electronic medical record were included in monthly numerators. Members with preexisting postmenopausal bleeding or abnormal uterine bleeding, or who were at increased risk of bleeding due to other health conditions, were excluded from monthly calculations. We used segmented regression analysis to estimate changes in the incidence of postmenopausal bleeding diagnoses from 2018 through 2021 in Kaiser Permanente Northwest members meeting the inclusion criteria, stratified by COVID-19 vaccination status in 2021. In addition, we identified all members with ≥1 COVID-19 vaccination between December 14, 2020 and August 14, 2021, who had an incident postmenopausal bleeding diagnosis within 60 days of vaccination. COVID-19 vaccination, diagnostic procedures, and presumed bleeding etiology were assessed through chart review and described. A temporal scan statistic was run on all cases without clear bleeding etiology. RESULTS: In a population of 75,530 to 82,693 individuals per month, there was no statistically significant difference in the rate of incident postmenopausal bleeding diagnoses before and after COVID-19 vaccine introduction (P=.59). A total of 104 individuals had incident postmenopausal bleeding diagnosed within 60 days following COVID-19 vaccination; 76% of cases (79/104) were confirmed as postvaccination postmenopausal bleeding after chart review. Median time from vaccination to bleeding onset was 21 days (range: 2-54 days). Among the 56 postmenopausal bleeding cases with a provider-attributed etiology, the common causes of bleeding were uterine or cervical lesions (50% [28/56]), hormone replacement therapy (13% [7/56]), and proliferative endometrium (13% [7/56]). Among the 23 cases without a clear etiology, there was no statistically significant clustering of postmenopausal bleeding onset following vaccination. CONCLUSION: Within this integrated health system, introduction of COVID-19 vaccines was not associated with an increase in incident postmenopausal bleeding diagnoses. Diagnosis of postmenopausal bleeding in the 60 days following receipt of a COVID-19 vaccination was rare.

Influenza Vaccination Among Pregnant People Before and During the Coronavirus Disease 2019 (COVID-19) Pandemic.

There are limited data on influenza vaccination coverage among pregnant people in the United States during the coronavirus disease 2019 (COVID-19) pandemic. Within the Vaccine Safety Datalink, we conducted a retrospective cohort study to examine influenza vaccination coverage during the 2016-2017 through the 2021-2022 influenza seasons among pregnant people aged 18-49 years. Using influenza vaccines administered through March each season, we assessed crude coverage by demographic and clinical characteristics. Annual influenza vaccination coverage increased from the 2016-2017 season (63.0%) to a high of 71.0% in the 2019-2020 season. After the start of the COVID-19 pandemic, it decreased to a low of 56.4% (2021-2022). In each of the six seasons, coverage was lowest among pregnant people aged 18-24 years and among non-Hispanic Black pregnant people. The 2021-2022 season had the lowest coverage across all age and race and ethnicity groups. The recent decreases highlight the need for continued efforts to improve coverage among pregnant people.

Patient Interest in Receiving Assistance with Self-Reported Social Risks.

OBJECTIVES: This study evaluated how often patients who reported social risk factors requested assistance with these risks in an integrated health system. METHODS: We examined how self-reports of risk related to stated desire for help with that risk reported during social risk screenings at Kaiser Permanente Northwest (KPNW). We examined how patient characteristics were associated with desire for help with each social risk domain using logistic regression. RESULTS: Approximately 24% (n = 7,807) of the 32,865 KPNW members aged ≥ 18 years who were screened between June 1, 2017, and December 31, 2019, reported at least 1 social risk. More than half of patients who reported a risk were risk/help concordant (i.e., they also wanted help with that risk). The highest concordance (81.7%) was observed among patients reporting medical financial hardship. Several demographic, health, and other factors were associated with concordance across domains. CONCLUSIONS: Patients do not request assistance for all reported social needs. Our findings could help shape future work examining patients' reasons for not accepting assistance and developing interventions to help patients with high social risk more effectively.

Examining the association of medical-dental integration with closure of medical care gaps among the elderly population.

BACKGROUND: The integration of medical and dental care in the dental setting offers a unique opportunity to close medical care gaps, such as providing immunizations and laboratory-based tests, compared with traditional nonintegrated settings. METHODS: We used a matched cohort study design among patients 65 years or older (n = 2,578) with an index dental visit to the Kaiser Permanente Northwest medical-dental integration (MDI) program from June 1, 2018, through December 31, 2019. MDI patients were matched 1:1 to non-MDI controls (n = 2,578) on 14 characteristics. The Kaiser Permanente Northwest MDI program focuses on closing 23 preventive (for example, flu vaccines) and disease management care gaps (for example, glycated hemoglobin testing) within the dental setting. The closure of all care gaps (yes versus no) was the outcome for the analysis. Multivariable logistic regression was used to evaluate the association between exposure to the MDI program and level of office integration (least, moderate, and most integration) with closure of care gaps. All data were obtained through Kaiser Permanente Northwest's electronic health record. RESULTS: MDI patients had significantly higher odds (odds ratio [OR], 1.46, 95% confidence interval [CI], 1.29 to 1.65) of closing all medical care gaps than non-MDI patients. Greater MDI integration was associated with significantly higher odds of gap closure compared with non-MDI (least integration: OR, 1.18, 95% CI, 1.02 to 1.37; moderate integration: OR, 1.70, 95% CI, 1.36 to 2.12; most integration: OR, 2.08, 95% CI, 1.73 to 2.50). CONCLUSIONS: Patients receiving dental care in an MDI program had higher odds of closing medical care gaps compared with similar patients receiving dental care in a non-MDI program. PRACTICAL IMPLICATIONS: MDI is effective at facilitating delivery of preventive and disease management medical services.

Social Isolation Associated with Future Health Care Utilization.

Social isolation among individuals ages 65 years and older is associated with poor health outcomes. However, little is known about health care utilization patterns of socially isolated individuals. This retrospective, observational study evaluated associations between social isolation and hospital and emergency department (ED) utilization among Medicare patients ages 65 years and older. In a cohort of 18,557 Medicare members age 65 years and older at Kaiser Permanente Northwest, the authors compared rates of hospitalization and ED visits in the 12 months following a baseline survey between respondents who reported feeling lonely or socially isolated and those who did not, controlling for demographic and health variables and utilization in the 12 months prior to the survey. Statistical analysis was conducted in February 2020. In adjusted models, those who reported "sometimes" experiencing social isolation were more likely to have at least 1 hospital admission (odds ratio [ORsometimes]: 1.17, 95% confidence interval [CI]: 1.01-1.35, P = 0.04), than those who "rarely" or "never" experienced social isolation. Those who experienced social isolation "sometimes" or "often/always" were more likely to have at least 1 ED visit (ORsometimes: 1.28, 95% CI: 1.15-1.41, P < 0.0001, and ORoften/always: 1.51, 95% CI: 1.25-1.84, P < 0.0001, respectively) than those who "rarely" or "never" experienced social isolation. These findings suggest that self-reported social isolation may be predictive of future hospital admissions and ED utilization. Research is needed to determine how addressing social isolation needs within the health care system affects health care utilization and health outcomes.

Trends in smoking documentation rates in safety net clinics.

OBJECTIVE: To assess the impact of provider incentive policy on smoking status documentation. DATA SOURCES: Primary data were extracted from structured electronic medical records (EMRs) from 15 community health centers (CHCs). STUDY DESIGN: This was an observational study of data from 2006 to 2013, assessing changes in documentation of smoking status over time. DATA EXTRACTION METHODS: We extracted structured EMR data for patients age 18 and older with at least one primary care visit. PRINCIPAL FINDINGS: Rates of documented smoking status rose from 30 percent in 2006 to 90 percent in 2013; the largest increase occurred from 2011 to 2012 following policy changes (21.3% [95% CI, 8.2%, 34.4%] from the overall trend). Rates varied by clinic and across patient subgroups. CONCLUSIONS: Documentation of smoking status improved markedly after introduction of new federal standards. Further improvement in documentation is still needed, especially for males, nonwhite patients, those using opioids, and HIV + patients. More research is needed to study whether changes in documentation lead to improvements in counseling, cessation, and patient outcomes.

Demographic, Clinical, and Prescribing Characteristics Associated with Future Opioid Use in an Opioid-Naive Population in an Integrated Health System.

INTRODUCTION: Health systems and prescribers need additional tools to reduce the risk of opioid dependence, abuse, and overdose. Identifying opioid-naive individuals who are at risk of opioid dependence could allow for the development of needed interventions. METHODS: We conducted a retrospective cohort analysis of 23,804 adults in an integrated health system who had received a first opioid prescription between 2010 and 2015. We compared the demographic, clinical, and prescribing characteristics of individuals who later received a third opioid dispense at least 27 days later, indicating long-term opioid use, with those who did not. RESULTS: The strongest predictors of continued opioid use were an initial prescription dosage of 90 morphine milligram equivalence or more; prescription of extended-release opioids, rather than short-release; and being prescribed outside of a hospital setting. Patients with a third prescription were also more likely to be older than 45 years, white, and non-Hispanic and to have physical comorbidities or prior substance abuse or mental health diagnoses. DISCUSSION: Our findings are largely consistent with prior research but provide new insight into differences in continued opioid use by opioid type, prescribing location, ethnicity, and comorbidities. Together with previous research, our data support a pattern of higher opioid use among older adults but higher rates of diagnosed opioid abuse among younger adults. CONCLUSIONS: By identifying population characteristics associated with continued opioid use following a first prescription, our data pave the way for quality improvement interventions that target individuals who are at higher risk of opioid dependence.

Adherence to behavioral recommendations for weight loss and associated psychosocial factors among African American adults.

PURPOSE: To identify patterns of behavioral adherence among 388 African Americans who participated in the Weight Loss Maintenance trial and examine associated psychosocial factors. METHODS: Using repeated measures latent class analysis, we modeled patterns of adherence to recommendations regarding fruit and vegetable, total fat, and saturated fat intake and physical activity at baseline, 6, and 18 months. Latent classes were compared on the SF-36 (mental health composite and vitality subscale), Perceived Stress Scale, and PHQ-8 at each time point. RESULTS: Three distinct latent classes emerged: Nutrition Adherers (n = 96); Physical Activity Adherers (n = 61); and Non-Adherers (n = 231). All groups showed initial improvement in psychosocial measures followed by relapse. Non-Adherers had significantly lower mean mental health and vitality scores and higher depression scores than adherers at 6 and 18 months. CONCLUSION: Psychological well-being should be addressed with African Americans in weight loss treatment to enhance behavior change and improve weight loss outcomes.

The effect of multiple recruitment contacts on response rates and patterns of missing data in a survey of bladder cancer survivors 6 months after cystectomy.

PURPOSE: The Bladder Cancer Quality of Life Study collected detailed and sensitive patient-reported outcomes from bladder cancer survivors in the period after bladder removal surgery, when participation in survey research may present a burden. This paper describes the study recruitment methods and examines the response rates and patterns of missing data. METHODS: Detailed surveys focusing on quality of life, healthcare decision-making, and healthcare expenses were mailed to patients 5-7 months after cystectomy. We conducted up to 10 follow-up recruitment calls. We analyzed survey completion rates following each contact in relation to demographic and clinical characteristics, and patterns of missing data across survey content areas. RESULTS: The overall response rate was 71% (n = 269/379). This was consistent across patient clinical characteristics; response rates were significantly higher among patients over age 70 and significantly lower among racial and ethnic minority patients compared to non-Hispanic white patients. Each follow-up contact resulted in marginal survey completion rates of at least 10%. Rates of missing data were low across most content areas, even for potentially sensitive questions. Rates of missing data differed significantly by sex, age, and race/ethnicity. CONCLUSIONS: Despite the effort required to participate in research, this population of cancer survivors showed willingness to share detailed information about quality of life, health care decision-making, and expenses, soon after major cancer surgery. Additional contacts were effective at increasing participation. Response patterns differed by race/ethnicity and other demographic factors. Our data collection methods show that it is feasible to gather detailed patient-reported outcomes during this challenging period.

Association Between Social and Economic Needs With Future Healthcare Utilization.

INTRODUCTION: Unmet social and economic needs are associated with poor health outcomes, but little is known about how these needs are predictive of future healthcare utilization. This study examined the association of social and economic needs identified during medical visits with future hospitalizations and emergency department visits. METHODS: Individuals with electronic health record-coded social and economic needs during a primary care, emergency department, or urgent care visit at Kaiser Permanente Northwest from October 1, 2016 to November 31, 2017 (case patients) were identified, as well as individuals who had visits during that time period but had no electronic health record-coded needs (control patients). The 2 groups were compared on sociodemographic characteristics, comorbidities, and healthcare utilization in the prior year. Finally, logistic regression assessed the relationship between documented needs and hospitalizations and emergency department visits in the 12 months following the index visit, controlling for sociodemographic characteristics, comorbidities, and prior healthcare utilization. Statistical analysis was completed in April 2019. RESULTS: Case patients differed significantly from control patients on sociodemographic characteristics and had higher rates of comorbidities and prior healthcare utilization. Social and economic needs documented during the index visit were associated with significantly higher rates of hospitalization and emergency department visits in the 12 months following the visit, controlling for sociodemographic characteristics, comorbidities, and prior utilization. CONCLUSIONS: These results demonstrate that documented social and economic needs are a powerful predictor of future hospitalization and emergency department use and suggest the need for research into whether interventions to address these needs can influence healthcare utilization.

Origins of the concepts cause, cost, and goal in prereaching infants.

We investigated the origins and interrelations of causal knowledge and knowledge of agency in 3-month-old infants, who cannot yet effect changes in the world by reaching for, grasping, and picking up objects. Across 5 experiments, n = 152 prereaching infants viewed object-directed reaches that varied in efficiency (following the shortest physically possible path vs. a longer path), goal (lifting an object vs. causing a change in its state), and causal structure (action on contact vs. action at a distance and after a delay). Prereaching infants showed no strong looking preference between a person's efficient and inefficient reaches when the person grasped and displaced an object. When the person reached for and caused a change in the state of the object on contact, however, infants looked longer when this action was inefficient than when it was efficient. Three-month-old infants also showed a key signature of adults' and older infants' causal inferences: This looking preference was abolished if a short spatial and temporal gap separated the action from its effect. The basic intuition that people are causal agents, who navigate around physical constraints to change the state of the world, may be one important foundation for infants' ability to plan their own actions and learn from the acts of others.

Food Insecurity Associated with Self-Reported Falls Among Medicare Advantage Members.

More than 3 million older US adults injure themselves by falling each year. Falls are a major cause of morbidity and mortality for this population, and account for nearly $30 billion in Medicare expenditures annually. Falls have been linked to frailty and vitamin D deficiency, both of which are linked to low nutrient intake and food insecurity. This retrospective, observational study is the first the authors know of to directly assess the relationship between food insecurity and falls. The study sample consisted of 26,525 Medicare Advantage members at Kaiser Permanente Northwest, a group model health maintenance organization, who had completed a quality of care survey between April 2013 and March 2017 and who maintained continuous enrollment in the 12 months prior to the survey date. Multivariable logistic regression analysis was used to assess the association between self-reported food insecurity and falls; electronic health record variables for age, sex, socioeconomic status, comorbidity, and health care utilization were included as covariates. Medicare Advantage members who reported food insecurity had 1.69 times higher odds of experiencing a fall in the past year than those without food insecurity, in adjusted analysis. Age, sex, comorbidity, and health care utilization also were significantly associated with falls. Food insecurity is significantly associated with falls among Medicare Advantage members. Routine assessment for food insecurity within the health care system, with subsequent referral to food resources, may help reduce rates of falls in older populations.

Recovering from Cystectomy: Patient Perspectives.

BACKGROUND: Bladder cancer patients who undergo cystectomy and urinary diversion face functional and quality-of-life challenges. Little is known about these patients' experiences during decision-making, surgery, and recovery, or how they vary by treatment setting. OBJECTIVE: To learn about patients' experiences with treatment choice, surgical care, and recovery across health settings. Understanding patient experiences is essential to closing care gaps and developing patient-reported measures. METHODS: We conducted focus groups with cystectomy patients and family caregivers at a large comprehensive health care system (N = 32 patients) and an NCI-designated comprehensive cancer center (N = 25 patients and 5 caregivers). Using standard qualitative methods, we identified themes that are not well-represented in existing research. RESULTS: Across both systems, patients described variable experiences in decision-making about their cystectomy and urinary diversion. Some felt overwhelmed by information; others felt poorly informed. Many found self-care equipment challenging; many felt they knew little about what to expect regarding chemotherapy, recovery, and transitioning home. At times, health care personnel could not help manage patients' ostomies or catheterization equipment. Our study also contributes a grounded theoretical framework for describing meaningful domains of patient experience with cystectomy and urinary diversion. We identified a common trajectory that includes decision-making, surgery and post-operative recovery, mastery of self-care, and reintegration. CONCLUSIONS: Patients with radical cystectomy and urinary diversion report a wide variety of experiences not captured by quantitative measures. These findings demonstrate that many cystectomy patients could benefit from additional post-operative support. We offer a framework to measure patient-centered domains in future research.

Predictors of Long-Term Adherence to Multiple Health Behavior Recommendations for Weight Management.

BACKGROUND: We have demonstrated previously that patterns of behavioral adherence in the first 6 months of behavioral lifestyle interventions were associated with significant weight loss at 18 months. In this article, we extend this work to examine patterns of behavioral adherence over 18 months and to explore baseline demographic and psychosocial predictors. METHOD: Latent class analysis was applied separately to the Weight Loss Maintenance and PREMIER trials data to examine patterns of adherence to the following recommendations: (1) consuming ≥9 servings of fruits and vegetables per day, (2) ≤25% of energy from total fat, (3) ≤7% energy from saturated fat, and (4) ≥180 minutes of moderate-to-vigorous physical activity per week. Multinomial logistic regression was used to test demographic and psychosocial predictors of latent class membership. RESULTS: Four distinct subgroups with common patterns of behavioral adherence were identified in each trial including, Behavioral Maintainers, who maintained adherence to all behavioral recommendations for 1 year, Nonresponders, who did not adhere to the recommendations at any time point, and latent classes that reflected patterns of adherence to one or two behaviors or behavioral relapse. A significantly higher proportion of Behavioral Maintainers sustained ≥5% weight loss for 1 year compared with Nonresponders. Participants with higher vitality scores at baseline were more likely to belong to a latent class with long-term adherence to one or more recommendations than the Nonresponders class. CONCLUSIONS: Regular assessment of health behaviors and psychosocial measures such as vitality may help identify nonresponders and inform treatment tailoring to improve long-term behavioral and weight outcomes.

The Role of Gesture in Supporting Mental Representations: The Case of Mental Abacus Arithmetic.

People frequently gesture when problem-solving, particularly on tasks that require spatial transformation. Gesture often facilitates task performance by interacting with internal mental representations, but how this process works is not well understood. We investigated this question by exploring the case of mental abacus (MA), a technique in which users not only imagine moving beads on an abacus to compute sums, but also produce movements in gestures that accompany the calculations. Because the content of MA is transparent and readily manipulated, the task offers a unique window onto how gestures interface with mental representations. We find that the size and number of MA gestures reflect the length and difficulty of math problems. Also, by selectively interfering with aspects of gesture, we find that participants perform significantly worse on MA under motor interference, but that perceptual feedback is not critical for success on the task. We conclude that premotor processes involved in the planning of gestures are critical to mental representation in MA.

Approving cancer treatments based on endpoints other than overall survival: an analysis of historical data using the PACE Continuous Innovation Indicators™ (CII).

BACKGROUND: There is an active debate about the role that endpoints other than overall survival (OS) should play in the drug approval process. Yet the term 'surrogate endpoint' implies that OS is the only critical metric for regulatory approval of cancer treatments. We systematically analyzed the relationship between U.S. Food and Drug Administration (FDA) approval and publication of OS evidence to understand better the risks and benefits of delaying approval until OS evidence is available. SCOPE: Using the PACE Continuous Innovation Indicators (CII) platform, we analyzed the effects of cancer type, treatment goal, and year of approval on the lag time between FDA approval and publication of first significant OS finding for 53 treatments approved between 1952 and 2016 for 10 cancer types (n = 71 approved indications). FINDINGS: Greater than 59% of treatments were approved before significant OS data for the approved indication were published. Of the drugs in the sample, 31% had lags between approval and first published OS evidence of 4 years or longer. The average number of years between approval and first OS evidence varied by cancer type and did not reliably predict the eventual amount of OS evidence accumulated. CONCLUSIONS: Striking the right balance between early access and minimizing risk is a central challenge for regulators worldwide. We illustrate that endpoints other than OS have long helped to provide timely access to new medicines, including many current standards of care. We found that many critical drugs are approved many years before OS data are published, and that OS may not be the most appropriate endpoint in some treatment contexts. Our examination of approved treatments without significant OS data suggests contexts where OS may not be the most relevant endpoint and highlights the importance of using a wide variety of fit-for-purpose evidence types in the approval process.

Better together: Simultaneous presentation of speech and gesture in math instruction supports generalization and retention.

When teachers gesture during instruction, children retain and generalize what they are taught (Goldin-Meadow, 2014). But why does gesture have such a powerful effect on learning? Previous research shows that children learn most from a math lesson when teachers present one problem-solving strategy in speech while simultaneously presenting a different, but complementary, strategy in gesture (Singer & Goldin-Meadow, 2005). One possibility is that gesture is powerful in this context because it presents information simultaneously with speech. Alternatively, gesture may be effective simply because it involves the body, in which case the timing of information presented in speech and gesture may be less important for learning. Here we find evidence for the importance of simultaneity: 3rd grade children retain and generalize what they learn from a math lesson better when given instruction containing simultaneous speech and gesture than when given instruction containing sequential speech and gesture. Interpreting these results in the context of theories of multimodal learning, we find that gesture capitalizes on its synchrony with speech to promote learning that lasts and can be generalized.