Intentions to Use Cannabis Postpartum: A Qualitative Study of Pregnant Individuals Who Used Cannabis During Early Pregnancy.

Objective: To examine plans for postpartum cannabis use among pregnant individuals who used cannabis during early pregnancy. Materials and Methods: Eighteen virtual focus groups were conducted from November 17, 2021, to December 17, 2021, with 23 Black and 30 White pregnant adults in Kaiser Permanente Northern California, who self-reported prenatal cannabis use during early pregnancy. Focus groups were recorded, transcribed, and analyzed using thematic analysis. Results: The sample (N = 53) had a mean age of 30.3 years (standard deviation = 5.2) at recruitment; 70% reported daily, 25% weekly, and 6% ≤ monthly cannabis use at entrance to prenatal care. Some participants viewed cannabis as critical for coping with postpartum mental and physical health challenges, while others questioned whether cannabis use would fit with their parental lifestyle, and some planned to abstain altogether. Most planned to use cannabis postpartum, but with lower frequency than before pregnancy, and in ways consistent with harm reduction (e.g., smoking outside to avoid secondhand or thirdhand smoke exposure). Many were motivated to abstain from cannabis while breastfeeding, and some desired more data on the safety of cannabis and breastfeeding, or intended to "pump and dump," believing it would reduce potential transfer of Δ9-tetrahydrocannabinol (THC) to their infant. Responses from Black and White participants were generally similar, but White participants were more likely to report plans to use cannabis while breastfeeding and to want information about cannabis and breastfeeding. Conclusions: Pregnant individuals with prenatal cannabis use had varied plans for cannabis use postpartum. Many were motivated to abstain or use cannabis less frequently than pre-pregnancy, especially during lactation.

A patient activation intervention in primary care for patients with chronic pain on long term opioid therapy: results from a randomized control trial.

BACKGROUND: Given significant risks associated with long-term prescription opioid use, there is a need for non-pharmacological interventions for treating chronic pain. Activating patients to manage chronic pain has the potential to improve health outcomes. The ACTIVATE study was designed to evaluate the effectiveness of a 4-session patient activation intervention in primary care for patients on long-term opioid therapy. METHODS: The two-arm, pragmatic, randomized trial was conducted in two primary care clinics in an integrated health system from June 2015-August 2018. Consenting participants were randomized to the intervention (n = 189) or usual care (n = 187). Participants completed online and interviewer-administered surveys at baseline, 6- and 12- months follow-up. Prescription opioid use was extracted from the EHR. The primary outcome was patient activation assessed by the Patient Activation Measure (PAM). Secondary outcomes included mood, function, overall health, non-pharmacologic pain management strategies, and patient portal use. We conducted a repeated measure analysis and reported between-group differences at 12 months. RESULTS: At 12 months, the intervention and usual care arms had similar PAM scores. However, compared to usual care at 12 months, the intervention arm demonstrated: less moderate/severe depression (odds ratio [OR] = 0.40, 95%CI 0.18-0.87); higher overall health (OR = 3.14, 95%CI 1.64-6.01); greater use of the patient portal's health/wellness resources (OR = 2.50, 95%CI 1.42-4.40) and lab/immunization history (OR = 2.70, 95%CI 1.29-5.65); and greater use of meditation (OR = 2.72; 95%CI 1.61-4.58) and exercise/physical therapy (OR = 2.24, 95%CI 1.29-3.88). At 12 months, the intervention arm had a higher physical health measure (mean difference 1.63; 95%CI: 0.27-2.98). CONCLUSION: This trial evaluated the effectiveness of a primary care intervention in improving patient activation and patient-reported outcomes among adults with chronic pain on long-term opioid therapy. Despite a lack of improvement in patient activation, a brief intervention in primary care can improve outcomes such as depression, overall health, non-pharmacologic pain management, and engagement with the health system. TRIAL REGISTRATION: The study was registered on 10/27/14 on ClinicalTrials.gov (NCT02290223).

Neonatal outcomes associated with in utero cannabis exposure: a population-based retrospective cohort study.

BACKGROUND: The full spectrum of associations between in utero cannabis exposure and adverse neonatal outcomes is still unclear. OBJECTIVE: This study aimed to evaluate the associations between in utero cannabis exposure and neonatal outcomes. STUDY DESIGN: This population-based retrospective cohort study of singleton births among Kaiser Permanente Northern California members (January 1, 2011-July 31, 2020) included parent-infant dyads in which the pregnant parent was screened for cannabis use as part of standard prenatal care, generally upon entrance into care. Data were ascertained from electronic health records. Generalized estimating equation models were adjusted for sociodemographic characteristics, other non-cannabis prenatal substance use, medical and mental health comorbidities, and adequacy of prenatal care. In utero cannabis exposure was defined as self-reported use since becoming pregnant and/or a positive urine toxicology test for cannabis at any time during pregnancy (yes/no; primary exposure). Frequency of use was self-reported and categorized as daily, weekly, monthly or less, never, or unknown (secondary exposure). Neonatal outcomes included low birthweight, small for gestational age, preterm birth, neonatal intensive care unit admission, and infant respiratory support. RESULTS: Of 364,924 infants, 22,624 (6.2%) were exposed to cannabis in utero. After adjustment for potential confounders, including in utero exposure to other substances, in utero exposure to cannabis was associated with greater odds of low birthweight (adjusted odds ratio, 1.20; 95% confidence interval, 1.12-1.28), small for gestational age (adjusted odds ratio, 1.24; 95% confidence interval, 1.18-1.30), preterm birth (<37 weeks; adjusted odds ratio, 1.06; 95% confidence interval, 1.00-1.13), and neonatal intensive care unit admission (adjusted odds ratio, 1.06; 95% confidence interval, 1.01-1.11). There was a suggestive association with early preterm birth (<34 weeks; adjusted odds ratio, 1.11; 95% confidence interval, 1.00-1.23; P=.055), but no significant association with respiratory support (adjusted odds ratio, 1.07; 95% confidence interval, 0.97-1.18). Dose-response analysis found an increasing likelihood of low birthweight and small for gestational age with increasing frequency of prenatal cannabis use by the pregnant individual. Sensitivity analyses further supported an increased likelihood of low birthweight and small for gestational age, although associations with other outcomes did not reach statistical significance. CONCLUSION: In utero cannabis exposure was associated with increased likelihood of low birthweight, small for gestational age, preterm birth, and neonatal intensive care unit admission. Clinicians should counsel individuals who are pregnant or considering pregnancy about the potential adverse neonatal health outcomes associated with prenatal cannabis use.

Patient Perceptions of Prenatal Cannabis Use and Implications for Clinicians.

OBJECTIVE: To understand pregnant patients' reasons for prenatal cannabis use and perceptions of safety, desired and undesirable health care experiences, and desired information about prenatal cannabis use and secondarily to understand racial differences in these perceptions and preferences. METHODS: We conducted a qualitative study including 18 semi-structured, race-concordant virtual focus groups with pregnant individuals who self-reported cannabis use at prenatal care entry in a large integrated health care system in Northern California from November 2021 to December 2021. The focus groups included semi-structured questions that were recorded, transcribed, and coded by the research team. Thematic analysis was used to analyze the data. RESULTS: Overall, 53 participants were included; 30 self-identified, as White and 23 self-identified as Black. Participants averaged 30.3 years of age (SD 5.2 years) and were on average at 20.9 weeks of gestation at study enrollment; 69.8% reported daily cannabis use, 24.5% reported weekly cannabis use, and 5.7% reported monthly or less cannabis use at entrance to prenatal care. Although some participants quit cannabis use in early pregnancy because of concerns about potential health risks, many perceived a lack of scientific evidence or believed that prenatal cannabis use was safe. Many preferred cannabis to over-the-counter or prescription medications for treating mood, morning sickness, pain, and sleep. Participants valued open interactions with obstetricians that acknowledged their motivations for use, and they desired information about potential risks through conversations and educational materials. White and Black participants' perspectives were generally similar, but a few Black participants uniquely described concerns about racial bias related to their prenatal cannabis use. CONCLUSION: Pregnant patients used cannabis to manage mood and medical symptoms, and many believed that prenatal cannabis use was safer than the use of prescription medications. Obstetrician-initiated, patient-centered conversations around prenatal cannabis use, advice to discontinue cannabis use during pregnancy, and exploration of willingness to switch to medically recommended interventions for pregnancy-related symptoms may benefit patients.

Exploring preferences for different modes of cannabis use during early pregnancy: A qualitative study.

OBJECTIVE: Rates of prenatal cannabis use are rising, yet little is known about modes of cannabis use during pregnancy. This focus group study with pregnant individuals aimed to examine use patterns and perceptions regarding common modes of prenatal cannabis use. METHOD: Kaiser Permanente Northern California pregnant adult patients who identified as White or Black and self-reported cannabis use during pregnancy were recruited to participate (N = 53; 40% Black, 60% White; Meanage = 30.3, SD = 5.2). Eighteen focus groups with race-concordant facilitators followed a semi-structured format that queried participants on their prenatal cannabis use, including preferred modes of use (e.g., vapes, blunts, dabs, joints, edibles, topicals, pipes). Focus group discussions were coded and analyzed using a general inductive approach. RESULTS: A range of modes were preferred, with no single mode predominant. Participants' preferences aligned with four themes: perceived effects and benefits of cannabis, health and safety, convenience and familiarity, and partner and friend influences. Participants sought modes that were accessible and familiar, provided consistent and quick relief for pregnancy-related symptoms, were aligned with partners or friends, and minimized perceived risks while also providing symptom relief. Participants desired evidence-based information about mode safety to better inform mode selection during pregnancy. CONCLUSIONS: A range of personal and social factors influenced mode preferences during pregnancy. Many participants desired to reduce harms and use cannabis more safely in pregnancy but received little mode-specific information to guide these preferences. Further research identifying mode-specific risks is needed to guide harm reduction approaches during pregnancy.

Patient Engagement in a Multimodal Digital Phenotyping Study of Opioid Use Disorder.

BACKGROUND: Multiple digital data sources can capture moment-to-moment information to advance a robust understanding of opioid use disorder (OUD) behavior, ultimately creating a digital phenotype for each patient. This information can lead to individualized interventions to improve treatment for OUD. OBJECTIVE: The aim is to examine patient engagement with multiple digital phenotyping methods among patients receiving buprenorphine medication for OUD. METHODS: The study enrolled 65 patients receiving buprenorphine for OUD between June 2020 and January 2021 from 4 addiction medicine programs in an integrated health care delivery system in Northern California. Ecological momentary assessment (EMA), sensor data, and social media data were collected by smartphone, smartwatch, and social media platforms over a 12-week period. Primary engagement outcomes were meeting measures of minimum phone carry (≥8 hours per day) and watch wear (≥18 hours per day) criteria, EMA response rates, social media consent rate, and data sparsity. Descriptive analyses, bivariate, and trend tests were performed. RESULTS: The participants' average age was 37 years, 47% of them were female, and 71% of them were White. On average, participants met phone carrying criteria on 94% of study days, met watch wearing criteria on 74% of days, and wore the watch to sleep on 77% of days. The mean EMA response rate was 70%, declining from 83% to 56% from week 1 to week 12. Among participants with social media accounts, 88% of them consented to providing data; of them, 55% of Facebook, 54% of Instagram, and 57% of Twitter participants provided data. The amount of social media data available varied widely across participants. No differences by age, sex, race, or ethnicity were observed for any outcomes. CONCLUSIONS: To our knowledge, this is the first study to capture these 3 digital data sources in this clinical population. Our findings demonstrate that patients receiving buprenorphine treatment for OUD had generally high engagement with multiple digital phenotyping data sources, but this was more limited for the social media data. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3389/fpsyt.2022.871916.

Pregnant individual's lived experience of cannabis use during the COVID-19 pandemic: a qualitative study.

Introduction: Quantitative studies indicate that the COVID-19 pandemic has contributed to increased rates of prenatal cannabis use. However, little is known about how the pandemic has impacted cannabis use from the perspective of pregnant individuals themselves. Our objective was to characterize COVID-19-related changes in cannabis use among pregnant individuals who used cannabis during the pandemic. Methods: We conducted 18 focus groups (from 11/17/2021 to 12/17/2021) with Black and White pregnant individuals aged 18+ who self-reported prenatal cannabis use during universal screening at entrance to prenatal care (at ~8 weeks gestation) in Kaiser Permanente Northern California. Virtual focus groups were transcribed and analyzed using thematic analysis. Results: The sample of 53 pregnant individuals (23 Black, 30 White) was 30.3 years old (SD = 5.2) on average, and most (70%) self-reported daily versus weekly or monthly prenatal cannabis use. Major themes regarding the impact of the pandemic on cannabis use included increases in use (resulting from depression, anxiety, stress, boredom), and changes in social use (less sharing of smoked cannabis products), modes of use (from smoking to other modes due to respiratory concerns) and source (from storefront retailers to delivery). Conclusion: Coping with mental health symptoms and stress were identified drivers of perceived pandemic-related increases in prenatal cannabis use in 2021. Pregnant individuals adapted their use in ways consistent with public health recommendations to decrease social contact and reduce or quit smoking to mitigate COVID-19 transmission and harms. Proactive, mental health outreach for pregnant individuals during future pandemic waves may reduce prenatal cannabis use.

Cannabis Use for Medical Reasons Among Patients in a Large California Health Care System After Legalization of Nonmedical Use.

OBJECTIVE: In 2018, California legalized the sale of cannabis for adult nonmedical use. To understand use of cannabis after legalization, we surveyed a stratified random sample of adults in a large health system (ages 19-64 years) with and without documented chronic pain about their reasons for cannabis use from November 2018 to March 2019. METHOD: We compared patients with and without chronic pain on measures for medical, nonmedical, pain-related, and mental health-related cannabis use based on self-reported symptoms. RESULTS: Patients with chronic pain reported higher past-year medical use (34.6%) compared to patients without chronic pain (22.8%), past-year pain-related use (29.7% vs. 15.5%), and past-year mental health-related use (24.8% vs. 18.9%). In adjusted models, relative to patients without chronic pain, those with chronic pain had a 6.2% (95% CI [0.010, 0.11]) higher probability of past-year medical cannabis use and an 8.0% (95% CI [0.035, 0.13]) higher probability of past-year pain-related cannabis use. CONCLUSIONS: Compared to patients without chronic pain, patients with chronic pain were more likely to use cannabis for reasons related to medical and pain symptoms in the past year. Use for past-year mental health symptoms did not differ between these two groups. Cannabis use among patients with and without chronic pain is common after legalization for nonmedical use, and understanding reasons for use is important to improve overall patient care.

Association of the COVID-19 Pandemic With Unstable and/or Unsafe Living Situations and Intimate Partner Violence Among Pregnant Individuals.

Importance: The social, behavioral, and economic consequences of the COVID-19 pandemic may be associated with unstable and/or unsafe living situations and intimate partner violence (IPV) among pregnant individuals. Objective: To investigate trends in unstable and/or unsafe living situations and IPV among pregnant individuals prior to and during the COVID-19 pandemic. Design, Setting, and Participants: A cross-sectional population-based interrupted time-series analysis was conducted among Kaiser Permanente Northern California members who were pregnant and screened for unstable and/or unsafe living situation and IPV as part of standard prenatal care between January 1, 2019, and December 31, 2020. Exposures: COVID-19 pandemic (prepandemic period: January 1, 2019, to March 31, 2020; during pandemic period: April 1 to December 31, 2020). Main Outcomes and Measures: The 2 outcomes were unstable and/or unsafe living situations and IPV. Data were extracted from electronic health records. Interrupted time-series models were fit and adjusted for age and race and ethnicity. Results: The study sample included 77 310 pregnancies (74 663 individuals); 27.4% of the individuals were Asian or Pacific Islander, 6.5% were Black, 29.0% were Hispanic, 32.3% were non-Hispanic White, and 4.8% were other/unknown/multiracial, with a mean (SD) age of 30.9 (5.3) years. Across the 24-month study period there was an increasing trend in the standardized rate of unsafe and/or unstable living situations (2.2%; rate ratio [RR], 1.022; 95% CI, 1.016-1.029 per month) and IPV (4.9%; RR, 1.049; 95% CI, 1.021-1.078 per month). The ITS model indicated a 38% increase (RR, 1.38; 95% CI, 1.13-1.69) in the first month of the pandemic for unsafe and/or unstable living situation, with a return to the overall trend afterward for the study period. For IPV, the interrupted time-series model suggested an increase of 101% (RR, 2.01; 95% CI, 1.20-3.37) in the first 2 months of the pandemic. Conclusions and Relevance: This cross-sectional study noted an overall increase in unstable and/or unsafe living situations and IPV over the 24-month period, with a temporary increase associated with the COVID-19 pandemic. It may be useful for emergency response plans to include IPV safeguards for future pandemics. These findings suggest the need for prenatal screening for unsafe and/or unstable living situations and IPV coupled with referral to appropriate support services and preventive interventions.

Association of cannabis use during pregnancy with severe acute respiratory syndrome coronavirus 2 infection: a retrospective cohort study.

BACKGROUND AND AIMS: Cannabis use is increasingly common among pregnant individuals and might be a risk factor for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We aimed to test whether prenatal cannabis use is associated with increased risk of SARS-CoV-2 infection during pregnancy. DESIGN: This is a retrospective cohort study. SETTING: The study was conducted in California, USA. PARTICIPANTS: A total of 58 114 pregnancies (with outcomes from 5 March 2020 to 30 September 2021) among 57 287 unique pregnant women aged 14-54 years who were screened for prenatal substance use, enrolled in Kaiser Permanente Northern California (KPNC) (a health-care system) and had not tested positive for COVID-19 prior to pregnancy onset. MEASUREMENTS: We utilized data from the KPNC electronic health record. Cannabis use status (current, recently quit and non-user) was based on universal screenings during prenatal care (including urine toxicology testing and self-reported use on a self-administered questionnaire). SARS-CoV-2 infection [based on polymerase chain reaction (PCR) tests] was estimated in time-to-event analyses using Cox proportional hazard regression models adjusting for covariates. Secondary analyses examined differences in (a) SARS-CoV-2 testing rates and (b) SARS-CoV-2 infection rates among those tested. FINDINGS: We observed 348 810 person-months of follow-up time in our cohort with 41 064 SARS-CoV-2 PCR tests and 6% (n = 2414) of tests being positive. At the start of follow-up, 7% of pregnant individuals had current use, 12% had recently quit and 81% did not use cannabis. Adjusting for covariates, current use was associated with lower rates of SARS-CoV-2 infection [adjusted hazard ratio (aHR) = 0.60, 95% confidence interval (CI) = 0.49-0.74 than non-use. Those who had recently quit did not differ from non-cannabis users in infection rates (aHR = 0.96, 95% CI = 0.86-1.08). Sensitivity analyses among patients who received a SARS-CoV-2 test also found lower odds of infection associated with current versus no cannabis use (aOR = 0.76, CI = 0.61-0.93). CONCLUSIONS: Current cannabis use appears to be associated with a reduced risk of SARS-CoV-2 infection among pregnant individuals.

Perceptions About Cannabis Following Legalization Among Pregnant Individuals With Prenatal Cannabis Use in California.

Importance: As rates of prenatal cannabis use increase and cannabis legalization spreads across the US, studies are needed to understand the potential impacts of legalization from the perspectives of pregnant individuals who use cannabis. Objective: To characterize pregnant individuals' perspectives on legalization of cannabis for adult use in California (effective in 2018) in relation to prenatal cannabis use behaviors and beliefs. Design, Setting, and Participants: This qualitative study was conducted in Kaiser Permanente Northern California, a large health care system with universal screening for self-reported cannabis use at entrance to prenatal care. Eighteen semistructured focus groups were conducted from November 17 to December 17, 2021, using a secure video conferencing platform with Black and White pregnant participants who self-reported cannabis use during early pregnancy. Data were analyzed from March to June 2022. Main Outcomes and Measures: Video-recorded interviews were transcribed and analyzed using thematic analysis to identify major themes and subthemes. Results: Among 53 participants (mean [SD] age, 30.3 [5.2] years), 23 (43%) identified as non-Hispanic Black and 30 (57%) identified as non-Hispanic White; 16 participants (30%) reported continued cannabis use at the time of recruitment. Major themes regarding the perceived impact of legalization included easier access (via retailers and delivery), greater acceptance (including reduced stigma and more discussions about prenatal cannabis use with health care practitioners), and trust in cannabis retailers (including safety and effectiveness of diverse products sold and perceptions of cannabis retailer employees as knowledgeable, nonjudgmental, and caring). Responses were mixed about whether retailer marketing and advertising were associated with prenatal cannabis use and whether legalization resulted in reduced concerns about Child Protective Services involvement. Conclusion and Relevance: The findings of this qualitative study suggest pregnant individuals perceive cannabis legalization as having reduced barriers to prenatal cannabis use and that legalization has created challenges and opportunities for supporting the health of pregnant individuals. The results of this qualitative study highlight key areas that can be further explored in future educational materials, public health campaigns, and policy adaptations to address increasing rates of prenatal cannabis use.

Geographic Accessibility of Retail Cannabis in Northern California and Prenatal Cannabis Use During the COVID-19 Pandemic.

Importance: Prenatal cannabis use is associated with health risks for mothers and their children. Prior research suggests that rates of prenatal cannabis use in Northern California increased during the COVID-19 pandemic, but it is unknown whether increases varied with the local cannabis retail and policy environment. Objective: To test whether pandemic-related increases in prenatal cannabis use were greater among pregnant individuals with greater retail availability of cannabis around their homes or among those living in jurisdictions that allowed storefront retailers. Design, Setting, and Participants: A cross-sectional, population-based time series study used data from pregnancies in the Kaiser Permanente Northern California health care system screened for cannabis use before (January 1, 2019, to March 31, 2020) and during (April 1 to December 31, 2020) the early COVID-19 pandemic. Proximity to the nearest retailer and number of retailers within a 15-minute drive from one's home and local cannabis storefront retailer policy (banned vs permitted) were calculated. Interrupted time series models were fit using multiplicative and additive Poisson regression, adjusting for age and race and ethnicity. Exposures: The COVID-19 pandemic. Main Outcomes and Measures: Prenatal cannabis use based on universal urine toxicology tests conducted during early pregnancy at entrance to prenatal care. Results: The sample (n = 99 127 pregnancies) included 26.2% Asian or Pacific Islander, 6.8% Black, 27.6% Hispanic, 34.4% non-Hispanic White, and 4.9% other, unknown, or multiracial individuals, with a mean (SD) age of 30.8 (5.3) years. Prenatal cannabis use before (6.8%) and during (8.2%) the pandemic was associated with closer proximity to a retailer, greater retailer density, and residing in a jurisdiction that permitted vs banned retailers. There was a greater absolute increase in cannabis use from before to during the pandemic among those within a 10-minute drive (<10 minutes: adjusted rate difference [aRD], 0.93 cases/100 patients; 95% CI, 0.56-1.29 cases/100 patients; ≥10 minutes: aRD, 0.40 cases/100 patients; 95% CI, 0.12-0.68 cases/100 patients; interaction P = .02). Otherwise, relative and absolute rates increased similarly across categories of cannabis retailer proximity/density and local policy (interaction P > .05). Conclusions and Relevance: Prenatal cannabis use was more common among individuals living in areas with greater retail availability of cannabis. Although relative rates increased similarly during the pandemic regardless of local cannabis retail and policy environment, there was a larger absolute increase associated with living closer to a storefront cannabis retailer. Continued monitoring of local cannabis policy, the retail environment, and prenatal cannabis use is needed.

The Feasibility and Utility of Harnessing Digital Health to Understand Clinical Trajectories in Medication Treatment for Opioid Use Disorder: D-TECT Study Design and Methodological Considerations.

Introduction: Across the U.S., the prevalence of opioid use disorder (OUD) and the rates of opioid overdoses have risen precipitously in recent years. Several effective medications for OUD (MOUD) exist and have been shown to be life-saving. A large volume of research has identified a confluence of factors that predict attrition and continued substance use during substance use disorder treatment. However, much of this literature has examined a small set of potential moderators or mediators of outcomes in MOUD treatment and may lead to over-simplified accounts of treatment non-adherence. Digital health methodologies offer great promise for capturing intensive, longitudinal ecologically-valid data from individuals in MOUD treatment to extend our understanding of factors that impact treatment engagement and outcomes. Methods: This paper describes the protocol (including the study design and methodological considerations) from a novel study supported by the National Drug Abuse Treatment Clinical Trials Network at the National Institute on Drug Abuse (NIDA). This study (D-TECT) primarily seeks to evaluate the feasibility of collecting ecological momentary assessment (EMA), smartphone and smartwatch sensor data, and social media data among patients in outpatient MOUD treatment. It secondarily seeks to examine the utility of EMA, digital sensing, and social media data (separately and compared to one another) in predicting MOUD treatment retention, opioid use events, and medication adherence [as captured in electronic health records (EHR) and EMA data]. To our knowledge, this is the first project to include all three sources of digitally derived data (EMA, digital sensing, and social media) in understanding the clinical trajectories of patients in MOUD treatment. These multiple data streams will allow us to understand the relative and combined utility of collecting digital data from these diverse data sources. The inclusion of EHR data allows us to focus on the utility of digital health data in predicting objectively measured clinical outcomes. Discussion: Results may be useful in elucidating novel relations between digital data sources and OUD treatment outcomes. It may also inform approaches to enhancing outcomes measurement in clinical trials by allowing for the assessment of dynamic interactions between individuals' daily lives and their MOUD treatment response. Clinical Trial Registration: Identifier: NCT04535583.

Maternal pregnancy loss, birth characteristics, and childhood leukemia (United States).

OBJECTIVE: The authors evaluated the relation between maternal pregnancy loss, birth characteristics, and childhood leukemia in the Northern California Childhood Leukemia Study. METHODS: Incident cases of childhood leukemia (age 0-14 years) were rapidly ascertained, and controls were randomly selected from birth records and individually matched to cases. A total of 366 cases [313 acute lymphoblastic leukemia (ALL) and 53 acute myeloid leukemia (AML)] and 460 controls were included in this analysis. The biological mothers of all subjects provided detailed reproductive history and birth characteristics of the index children during a personal interview. Odds ratio (OR) and 95% confidence intervals (CI) were estimated using conditional logistic regression. Data on maternal pregnancy loss and birth characteristics were also available from the birth certificates of 96.3% of all subjects. RESULTS: History of miscarriage was associated with a significantly increased risk of AML (OR = 2.94, 95% CI: 1.03, 8.34), but not ALL. Neither birth weight, birth order, or parental ages appeared to be an important predictor of the risk of ALL or AML. A comparison between data from two different sources (interview versus birth certificate) indicated good reproducibility and offered some evidence against recall bias. CONCLUSION: Maternal history of miscarriage is associated with an increased risk of childhood AML.

Ethnic difference in daycare attendance, early infections, and risk of childhood acute lymphoblastic leukemia.

A role for infectious agents has been proposed in the etiology of childhood acute lymphoblastic leukemia (ALL), particularly for common ALL (c-ALL; ALL diagnosed in children ages 2-5 years and expressing CD10 and CD19 surface antigens). We evaluated the possible etiologic role of daycare attendance (a proxy measure for exposure to infectious agents) and infections during infancy in the Northern California Childhood Leukemia Study. A total of 294 incident ALL cases (ages 1-14 years) and 376 individually matched controls were included in this analysis. In non-Hispanic White children, daycare attendance measured by child-hours was associated with a significantly reduced risk of ALL. Compared with children who did not attend any daycare, the odds ratio (OR) for those who had >5,000 child-hours during infancy was 0.42 [95% confidence interval (95% CI), 0.18-0.99] for ALL and 0.33 (95% CI, 0.11-1.01) for c-ALL. Test for trend is also significant, which supports a dose-response relationship. The magnitude of effect associated with the same number of child-hours was stronger for daycare attendance during infancy than for daycare attendance before diagnosis. In addition, self-reported ear infection during infancy was associated with a significantly reduced risk of c-ALL (OR, 0.32; 95% CI, 0.14-0.74) in non-Hispanic White children. In Hispanic children, no association was observed among daycare attendance, early infections, and risk of childhood ALL or c-ALL. These results offer indirect yet strong support for the infectious disease hypothesis in the etiology of ALL in non-Hispanic White children and highlight an important ethnic difference.

Vaccination history and risk of childhood leukaemia.

BACKGROUND: Previous studies on vaccination and childhood leukaemia generated inconsistent results. METHODS: In the Northern California Childhood Leukaemia Study, a case-control study with incident cases and matched birth certificate controls, detailed written vaccination records were collected. A total of 323 cases aged 0-14 years at diagnosis and 409 controls were included in this analysis. All vaccinations were censored on the reference date (date of diagnosis for cases and the corresponding date for matched controls). Conditional logistic regression analysis was conducted, adjusting for potential confounding factors. A primary variable of interest is the number of administrations (doses) of various types of vaccines. RESULTS: Vaccinations against diphtheria, pertussis, tetanus, poliomyelitis, measles, mumps, and rubella were not associated with the risk of leukaemia. The odds ratio for each dose of Haemophilus influenzae type b (Hib) vaccine was 0.81 (95% CI 0.68-0.96). Compared with children who received two or fewer doses of Hib vaccine, those who received three or more doses had a significantly reduced risk of childhood leukaemia (odds ratio = 0.55, 95% confidence interval 0.32-0.94). The number of doses of hepatitis B vaccine received was not associated with leukaemia risk. CONCLUSIONS: Hib vaccination is associated with a reduced risk of childhood leukaemia. Future studies with detailed exposure assessment and large sample sizes are needed to further address the role of vaccinations in the etiology of childhood leukaemia.

Control selection strategies in case-control studies of childhood diseases.

To address concerns regarding the representativeness of controls in case-control studies, two selection strategies were evaluated in a study of childhood leukemia, which commenced in California in 1995. The authors selected two controls per case: one from among children identified by using computerized birth records and located successfully, the other from a roster of friends; both were matched on demographic factors. Sixty-four birth certificate-friend control pairs were enrolled (n = 128). Additionally, 192 "ideal" controls were selected without tracing from the birth records. Data on parental ages, parental education, mother's reproductive history, and birth weight were obtained from the birth certificates of all 320 subjects. For all variables except birth weight, the differences between birth certificate and ideal controls were smaller than those between friend and ideal controls. None of the differences between birth certificate and ideal controls was significant, whereas two factors were significantly different between friend and ideal controls. These findings suggest that friend controls may be less representative than birth certificate controls. Despite difficulty in tracing and a seemingly low participation rate (49.0% for 560 enrolled birth certificate controls), using birth records to recruit controls appears to provide a representative sample of children and an opportunity to assess the representativeness of controls.