Use of Artificial Intelligence in Improving Outcomes in Heart Disease: A Scientific Statement From the American Heart Association.

A major focus of academia, industry, and global governmental agencies is to develop and apply artificial intelligence and other advanced analytical tools to transform health care delivery. The American Heart Association supports the creation of tools and services that would further the science and practice of precision medicine by enabling more precise approaches to cardiovascular and stroke research, prevention, and care of individuals and populations. Nevertheless, several challenges exist, and few artificial intelligence tools have been shown to improve cardiovascular and stroke care sufficiently to be widely adopted. This scientific statement outlines the current state of the art on the use of artificial intelligence algorithms and data science in the diagnosis, classification, and treatment of cardiovascular disease. It also sets out to advance this mission, focusing on how digital tools and, in particular, artificial intelligence may provide clinical and mechanistic insights, address bias in clinical studies, and facilitate education and implementation science to improve cardiovascular and stroke outcomes. Last, a key objective of this scientific statement is to further the field by identifying best practices, gaps, and challenges for interested stakeholders.

Principles for Health Information Collection, Sharing, and Use: A Policy Statement From the American Heart Association.

The evolution of the electronic health record, combined with advances in data curation and analytic technologies, increasingly enables data sharing and harmonization. Advances in the analysis of health-related and health-proxy information have already accelerated research discoveries and improved patient care. This American Heart Association policy statement discusses how broad data sharing can be an enabling driver of progress by providing data to develop, test, and benchmark innovative methods, scalable insights, and potential new paradigms for data storage and workflow. Along with these advances come concerns about the sensitive nature of some health data, equity considerations about the involvement of historically excluded communities, and the complex intersection of laws attempting to govern behavior. Data-sharing principles are therefore necessary across a wide swath of entities, including parties who collect health information, funders, researchers, patients, legislatures, commercial companies, and regulatory departments and agencies. This policy statement outlines some of the key equity and legal background relevant to health data sharing and responsible management. It then articulates principles that will guide the American Heart Association's engagement in public policy related to data collection, sharing, and use to continue to inform its work across the research enterprise, as well as specific examples of how these principles might be applied in the policy landscape. The goal of these principles is to improve policy to support the use or reuse of health information in ways that are respectful of patients and research participants, equitable in impact in terms of both risks and potential benefits, and beneficial across broad and demographically diverse communities in the United States.

Design and Rationale of the Social Determinants of the Risk of Hypertension in Women of Reproductive Age (SAFE HEART) Study: An American Heart Association Research Goes Red Initiative.

BACKGROUND: Cardiovascular health literacy (CVHL) and social determinants of health (SDoH) play interconnected and critical roles in shaping cardiovascular health (CVH) outcomes. However, awareness of CVH risk has declined markedly, from 65% of women being aware that cardiovascular disease (CVD) is the leading cause of death for women in 2009 to just 44% being aware in 2019. The American Heart Association Research Goes Red (RGR) initiative seeks to develop an open-source, longitudinal, dynamic registry that will help women to be aware of and participate in research studies, and to learn about CVD prevention. We proposed to leverage this platform, particularly among Black and Hispanic women of reproductive age, to address CVHL gaps and advance health equity. METHODS: The primary objective of the study is to evaluate the cross-sectional association of cardiovascular health literacy (CVHL), SDoH using a polysocial score, and CVH in women of reproductive age at increased risk of developing hypertension (HTN). To achieve this we will use a cross-sectional study design, that engages women already enrolled in the RGR registry (registry-enrolled). To enhance the racial and ethnic/social economic diversity of the cohort, we will additionally enroll 300 women from the Baltimore and Washington D.C. community into the Social Determinants of the Risk of Hypertension in Women of Reproductive Age (SAFE HEART) Study. Community-enrolled and registry-enrolled women will undergo baseline social phenotyping including detailed SDoH questionnaire, CVH metrics assessment, and CVHL assessment. The secondary objective is to assess whether a 4-month active health education intervention will result in a change in CVHL in the 300 community-enrolled women. DISCUSSION: The SAFE HEART study examines the association between CVHL, SDoH, and CVH, with a focus on racial and ethnic minority groups and socioeconomically disadvantaged women of reproductive age, and the ability to improve these parameters by an educational intervention. These findings will inform the future development of community-engaged strategies that address CVHL and SDoH among women of reproductive age.

Research Goes Red: Early Experience With a Participant-Centric Registry.

RATIONALE: Cardiovascular disease remains the leading cause of death in women. To address its determinants including persisting cardiovascular risk factors amplified by sex and race inequities, novel personalized approaches are needed grounded in the engagement of participants in research and prevention. OBJECTIVE: To report on a participant-centric and personalized dynamic registry designed to address persistent gaps in understanding and managing cardiovascular disease in women. METHODS AND RESULTS: The American Heart Association and Verily launched the Research Goes Red registry (RGR) in 2019, as an online research platform available to consenting individuals over the age of 18 years in the United States. RGR aims to bring participants and researchers together to expand knowledge by collecting data and providing an open-source longitudinal dynamic registry for conducting research studies. As of July 2021, 15 350 individuals have engaged with RGR. Mean age of participants was 48.0 48.0±0.2 years with a majority identifying as female and either non-Hispanic White (75.7%) or Black (10.5%). In addition to 6 targeted health surveys, RGR has deployed 2 American Heart Association-sponsored prospective clinical studies based on participants' areas of interest. The first study focuses on perimenopausal weight gain, developed in response to a health concerns survey. The second study is designed to test the use of social media campaigns to increase awareness and participation in cardiovascular disease research among underrepresented millennial women. CONCLUSIONS: RGR is a novel online participant-centric platform that has successfully engaged women and provided critical data on women's heart health to guide research. Priorities for the growth of RGR are centered on increasing reach and diversity of participants, and engaging researchers to work within their communities to leverage the platform to address knowledge gaps and improve women's health.

Reflections on co-producing an obesity-prevention toolkit for Islamic Religious Settings: a qualitative process evaluation.

BACKGROUND: Islamic leaders, staff, and Muslim parents in the UK are supportive of healthy lifestyle intervention delivery through Islamic Religious Settings. Such interventions are necessary given high obesity rates in British South Asian (40%) compared to White British (32%) children of equivalent age. Co-production can facilitate the development of culturally appropriate health interventions, however it can be theoretically and practically challenging, and evaluation of co-production within an Islamic Religious Setting context is lacking. The aim of this study was to examine the feasibility and acceptability of taking a co-production approach to develop an obesity-prevention toolkit for Islamic Religious Settings. METHODS: An obesity-prevention toolkit for use in Islamic Religious Settings, incorporating physical activity, healthy diet, and organisational change, has been co-produced to be evidence-informed and contextually relevant. A qualitative process evaluation was employed to examine experiences of co-production. Semi-structured interviews (n = 15) and a focus group (n = 5) were conducted with toolkit co-production stakeholders, e.g., subject experts, an Islamic scholar, and Islamic Religious Setting staff. Transcripts were analysed inductively using reflexive thematic analysis. RESULTS: The analysis revealed four major themes regarding stakeholders' experiences of co-producing a childhood obesity-prevention toolkit for Islamic Religious Settings. These themes are: (1) attitudes towards obesity-prevention through Islamic Religious Settings, (2) benefits of co-production including capacity building and ownership (3) negotiating involvement, power, and perspectives within the co-production process, and (4) the complexities of effective communication in co-production. CONCLUSION: This study adds to the evidence-base in support of delivering health promotion through faith settings. Taking a co-production approach to develop an obesity-prevention toolkit for Islamic Religious Settings provided benefit to the toolkit product and local stakeholders. The toolkit is currently being implemented across Bradford, UK and there is potential to adapt the toolkit to other geographical contexts, and for evaluating effectiveness for preventing obesity in British Muslim families.

How, when, and who should ask about pregnancy intentions in primary care? A qualitative study of women's preferences.

BACKGROUND: For health services to help people plan for or prevent pregnancy, health professionals need an acceptable way to identify individuals' preferences. OBJECTIVE: To assess women's views on the acceptability of specific questions about pregnancy preferences when asked by health professionals in a variety of primary care contexts. METHODS: One-to-one in-depth interviews with 13 women aged 18-48 from across the UK, involving role-play scenarios and ranking exercises. Interviews covered a range of settings and health professionals, different question wording, and ways of asking (in person or digitally). We conducted a thematic Framework Analysis, focussing on themes relating to feelings and preferences. RESULTS: Women were generally open to being asked about pregnancy preferences if they understood the rationale, it was asked in a relevant context, such as in women's health-related consultations, and there was follow-up. After signposting, an open question, such as 'How would you feel about having a baby in the next year?' was preferred in a face-to-face context as it enabled discussion. While some women valued a face-to-face discussion with a health professional, for others the privacy and convenience of a digital option was preferred; methods should be tailored to the target population. CONCLUSION: Discussion of pregnancy preferences via a range of formats is acceptable to, and valued by, women in the UK across a range of primary care settings. Acceptability to health professionals and feasibility of implementation needs further exploration and would benefit from greater public awareness of the benefits of pregnancy planning.

'Yeah, they suck. It's like they don't care about our health.' Medical mistrust among Black women under community supervision in New York city.

Black women in the USA experience some of the poorest health outcomes and this is especially true for those involved in the carceral system who are at elevated risks for HIV/STIs, reproductive health, and chronic diseases. This study aimed to investigate Black women's experience accessing healthcare services. We conducted semi-structured interviews with 43 women from Project EWORTH under community supervision in New York City. We analysed responses focusing on barriers to healthcare engagement. All interviews were recorded, and data analysis was conducted using NVivo. Themes influencing Black women's ability to engage with healthcare providers and systems included: 1) disclosed provider mistrust/judgement; 2) feeling disrespected by providers and the medical system; 3) mistrust of medical providers/system/hospital/government; 4) lack of health communication; 5) low health literacy; 6) provider gender preference. Findings highlight the need to improve trust and collaboration between healthcare providers and Black women. This study addresses the critical gap in understanding perceptions of discrimination, stigma, and barriers to attaining health care. Funders and accreditation agencies must hold providers and organisations accountable for acquiring and making available diversity, equity and inclusion training for providers, demonstrating increasingly equitable medical relationships through responsiveness to patient feedback, and increasing the number of Black providers.

Characteristics of drug-involved black women under community supervision; implications for retention in HIV clinical trials and healthcare.

This study examined retention and its relationship to mental health, substance use, and social determinants of health in a randomized clinical trial of a behavioral HIV/sexually transmitted infection prevention intervention with drug-involved Black women (N = 348) under community supervision programs in New York City. Using secondary analysis, we used logistic models to test the association between factors related to mental health, substance use, and social determinants of health and follow-up assessment completion (three, six, and 12 months). Participants who were diagnosed with schizophrenia had lower odds of retention. Participants who misused prescription opiates during their lifetime or food insecure in the past 90 days had higher odds of retention throughout the intervention.

Call to Action for Cardiovascular Disease in Women: Epidemiology, Awareness, Access, and Delivery of Equitable Health Care: A Presidential Advisory From the American Heart Association.

Addressing the pervasive gaps in knowledge and care delivery to reduce sex-based disparities and achieve equity is fundamental to the American Heart Association's commitment to advancing cardiovascular health for all by 2024. This presidential advisory serves as a call to action for the American Heart Association and other stakeholders around the globe to identify and remove barriers to health care access and quality for women. A concise and current summary of existing data across the areas of risk and prevention, access and delivery of equitable care, and awareness and education provides a framework to consider knowledge gaps and research needs critical toward achieving significant progress for the health and well-being of all women.

Community-Level Economic Distress, Race, and Risk of Adverse Outcomes After Heart Failure Hospitalization Among Medicare Beneficiaries.

BACKGROUND: Socioeconomic disadvantage is a strong determinant of adverse outcomes in patients with heart failure. However, the contribution of community-level economic distress to adverse outcomes in heart failure may differ across races and ethnicities. METHODS: Patients of self-reported Black, White, and Hispanic race and ethnicity hospitalized with heart failure between 2014 and 2019 were identified from the Medicare MedPAR Part A 100% Files. We used patient-level residential ZIP code to quantify community-level economic distress on the basis of the Distressed Community Index (quintile 5: economically distressed versus quintiles 1-4: nondistressed). The association of continuous and categorical measures (distressed versus nondistressed) of Distressed Community Index with 30-day, 6-month, and 1-year risk-adjusted mortality, readmission burden, and home time were assessed separately by race and ethnicity groups. RESULTS: The study included 1 611 586 White (13.2% economically distressed), 205 840 Black (50.6% economically distressed), and 89 199 Hispanic (27.3% economically distressed) patients. Among White patients, living in economically distressed (versus nondistressed) communities was significantly associated with a higher risk of adverse outcomes at 30-day and 1-year follow-up. Among Black and Hispanic patients, the risk of adverse outcomes associated with living in distressed versus nondistressed communities was not meaningfully different at 30 days and became more prominent by 1-year follow-up. Similarly, in the restricted cubic spline analysis, a stronger and more graded association was observed between Distressed Community Index score and risk of adverse outcomes in White patients (versus Black and Hispanic patients). Furthermore, the association between community-level economic distress and risk of adverse outcomes for Black patients differed in rural versus urban areas. Living in economically distressed communities was significantly associated with a higher risk of mortality and lower home time at 1-year follow-up in rural areas but not urban areas. CONCLUSIONS: The association between community-level economic distress and risk of adverse outcomes differs across race and ethnic groups, with a stronger association noted in White patients at short- and long-term follow-up. Among Black patients, the association of community-level economic distress with a higher risk of adverse outcomes is less evident in the short term and is more robust and significant in the long-term follow-up and rural areas.

Effects of Second Dose of SARS-CoV-2 Vaccination on Household Transmission, England.

A single SARS-CoV-2 vaccine dose reduces onward transmission from case-patients. We assessed the potential effects of receiving 2 doses on household transmission for case-patients in England and their household contacts. We used stratified Cox regression models to calculate hazard ratios (HRs) for contacts becoming secondary case-patients, comparing contacts of 2-dose vaccinated and unvaccinated index case-patients. We controlled for age, sex, and vaccination status of case-patients and contacts, as well as region, household composition, and relative socioeconomic condition based on household location. During the Alpha-dominant period, HRs were 0.19 (0.13-0.28) for contacts of 2-dose BNT162b2-vaccinated case-patients and 0.54 (0.41-0.69) for contacts of 2-dose Ch4dOx1-vaccinated case-patients; during the Delta-dominant period, HRs were higher, 0.74 (0.72-0.76) for BNT162b2 and 1.06 (1.04-1.08) for Ch4dOx1. Reduction of onward transmission was lower for index case-patients who tested positive ≥2 months after the second dose of either vaccine.

The late-evolving salmon and trout join the GnRH1 club.

Although it is known that the whitefish, an ancient salmonid, expresses three distinct gonadotropin-releasing hormone (GnRH) forms in the brain, it has been thought that the later-evolving salmonids (salmon and trout) had only two types of GnRH: GnRH2 and GnRH3. We now provide evidence for the expression of GnRH1 in the gonads of Atlantic salmon by rapid amplification of cDNA ends, real-time quantitative PCR and immunohistochemistry. We examined six different salmonid genomes and found that each assembly has one gene that likely encodes a viable GnRH1 prepropeptide. In contrast to both functional GnRH2 and GnRH3 paralogs, the GnRH1 homeolog can no longer express the hormone. Furthermore, the viable salmonid GnRH1 mRNA is composed of only three exons, rather than the four exons that build the GnRH2 and GnRH3 mRNAs. Transcribed gnrh1 is broadly expressed (in 17/18 tissues examined), with relative abundance highest in the ovaries. Expression of the gnrh2 and gnrh3 mRNAs is more restricted, primarily to the brain, and not in the gonads. The GnRH1 proximal promoter presents composite binding elements that predict interactions with complexes that contain diverse cell fate and differentiation transcription factors. We provide immunological evidence for GnRH1 peptide in the nucleus of 1-year-old type A spermatogonia and cortical alveoli oocytes. GnRH1 peptide was not detected during other germ cell or reproductive stages. GnRH1 activity in the salmonid gonad may occur only during early stages of development and play a key role in a regulatory network that controls mitotic and/or meiotic processes within the germ cell.

How common is natural conception in women who have had a livebirth via assisted reproductive technology? Systematic review and meta-analysis.

STUDY QUESTION: What is the proportion of women who experience natural conception after a livebirth via assisted reproductive technology (ART)? SUMMARY ANSWER: Current evidence suggests that natural conception pregnancy may occur in at least one in five women after having a baby via IVF or ICSI. WHAT IS KNOWN ALREADY: It is widely known that some women having babies via ART go on to conceive naturally. This reproductive history is of media interest and often described as 'miracle' pregnancies. STUDY DESIGN, SIZE, DURATION: A systematic review with meta-analysis was carried out. Ovid Medline, Embase, and PsycINFO were searched until 24 September 2021 for English language, human studies from 1980. Search terms were used for the concepts of natural conception pregnancy, assisted reproduction, and livebirth. PARTICIPANTS/MATERIALS, SETTING, METHODS: The inclusion criterion was studies with an outcome measure of the proportion of women experiencing natural conception pregnancy after an ART livebirth. Quality of studies was assessed using the Critical Appraisal Skills Programme cohort study checklist or AXIS Appraisal tool for cross-sectional studies, and a risk of bias assessment was carried out. No studies were excluded based on quality. Random-effects meta-analyses were adopted to produce a pooled effect estimate of the proportion of natural conception pregnancy after ART livebirth. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 1108 distinct studies were identified, resulting in 54 studies after screening by title and abstract. Eleven studies including 5180 women were selected for this review. The included studies were mostly of moderate quality with a maximum follow-up period ranging from 2 to 15 years. Four studies reported natural conception livebirths which were used as known underestimates of natural conception pregnancies. The pooled estimate for the proportion of women having natural conception pregnancies after ART livebirth was 0.20 (95% CI, 0.17-0.22). LIMITATIONS, REASONS FOR CAUTION: The studies varied widely according to methodology, population, cause of subfertility, type and outcome of fertility treatment, and length of follow-up, leading to potential bias relating to confounding, selection bias, and missing data. WIDER IMPLICATIONS OF THE FINDINGS: Current evidence suggests that contrary to widely held views, natural conception pregnancy after ART livebirth is far from rare. National, data-linked studies are needed to provide more accurate estimates of this incidence and analysis of associated factors and trends over time to facilitate tailored counselling of couples considering further ART. STUDY FUNDING/COMPETING INTEREST(S): This work was conducted as part of an academic clinical fellowship awarded to AT by the National Institute for Health Research (NIHR). NIHR has had no input into the study design, data collection, and analysis, nor the writing of this study. No authors have any conflicts of interest. REGISTRATION NUMBER: PROSPERO (CRD42022322627).

Delivery of Cervical and Colorectal Cancer Screenings During the Pandemic in Community Health Centers: Practice Changes and Recovery Strategies.

BACKGROUND: The coronavirus disease 2019 pandemic led to clinical practice changes, which affected cancer preventive care delivery. OBJECTIVES: To investigate the impact of the coronavirus disease 2019 pandemic on the delivery of colorectal cancer (CRC) and cervical cancer (CVC) screenings. RESEARCH DESIGN: Parallel mixed methods design using electronic health record data (extracted between January 2019 and July 2021). Study results focused on 3 pandemic-related periods: March-May 2020, June-October 2020, and November 2020-September 2021. SUBJECTS: Two hundred seventeen community health centers located in 13 states and 29 semistructured interviews from 13 community health centers. MEASURES: Monthly up-to-date CRC and CVC screening rates and monthly rates of completed colonoscopies, fecal immunochemical test (FIT)/fecal occult blood test (FOBT) procedures, Papanicolaou tests among age and sex-eligible patients. Analysis used generalized estimating equations Poisson modeling. Qualitative analysts developed case summaries and created a cross-case data display for comparison. RESULTS: The results showed a reduction of 75% for colonoscopy [rate ratio (RR) = 0.250, 95% CI: 0.224-0.279], 78% for FIT/FOBT (RR = 0.218, 95% CI: 0.208-0.230), and 87% for Papanicolaou (RR = 0.130, 95% CI: 0.125-0.136) rates after the start of the pandemic. During this early pandemic period, CRC screening was impacted by hospitals halting services. Clinic staff moved toward FIT/FOBT screenings. CVC screening was impacted by guidelines encouraging pausing CVC screening, patient reluctance, and concerns about exposure. During the recovery period, leadership-driven preventive care prioritization and quality improvement capacity influenced CRC and CVC screening maintenance and recovery. CONCLUSIONS: Efforts supporting quality improvement capacity could be key actionable elements for these health centers to endure major disruptions to their care delivery system and to drive rapid recovery.

Global retrospective analysis of clinician- and patient-reported clinical characteristics and humanistic burden of patients with gastroesophageal cancers on first-line treatment.

BACKGROUND: Gastric cancer (GC), gastroesophageal junction cancer (GEJC), and esophageal adenocarcinoma (EAC), together, are leading causes of cancer deaths worldwide. Patient health-related quality of life (HRQoL) and well-being has become increasingly important alongside traditional oncologic outcomes for both patients and clinicians and may aid treatment decisions. We conducted a survey to examine the clinical characteristics, humanistic burden, and the effects of first-line (1L) treatment in patients with GC/GEJC/EAC, across different geographic regions, to address the paucity of real-world data. METHODS: Clinicians treating patients with unresectable advanced or metastatic GC/GEJC/EAC in China, France, Germany, Japan, the United Kingdom, and the United States, during April-October 2019, were invited to provide data on their patients' demographics, clinical characteristics, treatment, and HRQoL via medical chart reviews, clinician surveys, and patient questionnaires. Data were analyzed using descriptive statistics, regression analyses comparing active treatment and best supportive care. Patients were also stratified into subgroups that were identified either as human epidermal growth factor receptor 2 (HER2) positive, HER2 negative (which has a higher prevalence but for whom there are limited treatment options), or unknown HER2 status. RESULTS: Survey data were analyzed for 995 patients, 87% of whom were on active treatment, most commonly dual or triple chemotherapy. Demographics and clinical characteristics were similar across countries with most patients having GC and the lowest incidence of GEJC and EAC in China. Overall, most patients had de novo disease with good response to 1L treatment, while their HRQoL and well-being was significantly worse than the general population. In 682 patients on active treatment with HER2 negative or unknown status, HRQoL also appeared to be worse in those with recurrent disease. Regression analysis identified several drivers of treatment decisions and factors impacting patients' HRQoL, including stage of disease and comorbidities. CONCLUSIONS: In patients with advanced GC/GEJC/EAC, screening and assessment of HER2 status as well as patient-reported HRQoL outcomes are invaluable in aiding treatment decisions. The introduction of appropriate therapy soon after diagnosis has the prospect of achieving improved HRQoL and survival in these patients.

Using a validated instrument to assess pregnancy planning and preconception care at antenatal booking visits: a retrospective cohort study.

OBJECTIVE: To determine the completion rate for the London Measure of Unplanned Pregnancy (LMUP), a psychometrically validated measure of a woman's intention with regard to a current or recent pregnancy, during booking visits at two metropolitan antenatal care clinics; to identify socio-demographic characteristics associated with unplanned pregnancy. DESIGN, SETTING, PARTICIPANTS: Retrospective cohort study; analysis of LMUP data for women attending antenatal care booking consultations as public patients in the Sydney Local Health District, 31 December 2019 - 30 November 2020. MAIN OUTCOME MEASURES: Proportions of women with LMUP scores indicating unplanned (0-9) or planned pregnancies (10-12); associations between planned pregnancy and socio-demographic characteristics, crude and adjusted for age, parity, and socio-economic status (Index of Relative Socioeconomic Disadvantage). RESULTS: Of 4993 women with antenatal care bookings, the LMUP was completed by 2385 (47.8%; 1142 of 3564 women at the tertiary referral hospital [32.0%], 1118 of 1160 at the secondary hospital [96.3%]). Planned pregnancies were indicated by the total LMUP scores of 1684 women (70.6%); 1290 women (59.1%) reported no health actions in preparation for pregnancy. In multivariable analyses, planned pregnancies were more likely in all age groups than for women aged 24 years or younger (30-34 years: adjusted odds ratio [aOR], 2.54; 95% confidence interval [CI], 1.76-3.66; 35-39 years: aOR, 2.91; 95% CI, 1.95-4.33). The likelihood of planned pregnancy declined with increasing parity (v no previous births: three previous births: aOR, 0.25; 95% CI, 0.16-0.40; four or more previous births: aOR, 0.10; 95% CI, 0.05-0.19). CONCLUSION: Seven in ten women who completed the LMUP had planned their pregnancies, but fewer than half had undertaken health-related actions prior to conceiving. Higher parity was associated with unplanned pregnancy, indicating the importance of postpartum contraception advice. Overcoming barriers to implementing the LMUP more widely would enhance preconception health monitoring.

Using interprofessional education to build dynamic teams to help drive collaborative, coordinated and effective newborn care.

BACKGROUND: As countries strive to achieve sustainable development goal 3.2, high-quality medical education is crucial for high-quality neonatal care. Women are encouraged to deliver in health units attended by a skilled team. Traditionally, the team is doctors and nurses, but they are members of a large group of interdependent experts from other disciplines. Each discipline trains separately, yet the goal of good neonatal care is common to all. The use of interprofessional education breaks down these professional silos improving collaborative practice and promoting excellent clinical care. Introduction of new educational materials and training requires a rigorous approach to ensure sustainability. METHODS: An extensive needs assessment identified gaps in neonatal training. Specifically, there was a lack of inclusion of medical devices used in clinical care. In each country, national key stakeholders came together to develop and revise their own neonatal curricula, trainings or guidelines. A core writing education team were tasked to develop evidence-based materials on pertinent medical devices to include in these national materials. These then underwent internal and external review. A provider course for biomedical engineers and technicians was introduced. Skills labs were established to improve practical skills teaching. To improve the quality of teaching, a NEST360 generic instructors course (GIC) was developed. RESULTS: Twenty modules, 14 scenarios, 17 job aids and 34 videos have been published to date. Materials have been embedded into neonatal curricula and national trainings. Forty-one skills labs were installed in pre-service learning institutions and, up to June 2022, have been used by 7281 students. Pre- and in-service interprofessional training was implemented at all NEST360 institutions (clinical and biomedical). GIC courses were conducted at least twice a year in all countries. Three hundred seventeen nurses, biomedical and clinical staff have undertaken the GIC in all four countries. GIC participants report that the course has very positively influenced their teaching practice. CONCLUSIONS: Inclusion of key stakeholders throughout has ensured training is embedded within the four countries. Use of interprofessional education and inclusion of biomedical engineers and technicians has been very successful. Introduction of the GIC has developed a pool of high-quality educators for neonatal care. This approach has ensured that high-quality interprofessional neonatal training is included within national agendas for neonatal care and beyond.

Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF.

BACKGROUND: Medical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context. METHODS: We developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with < 75% agreement between respondents were discussed and voted on using Mentimeter™ at an in-person consensus meeting. FINDINGS: The TPP online survey was sent to 180 people, of which 103 responded (57%). The majority of respondents were implementers/clinicians (51%, 53/103), with 50% (52/103) from LMIC. Across the 15 TPPs, 403 (60%) of the 668 performance characteristics did not achieve > 75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023). CONCLUSIONS: These 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care.

The impact of depression at preconception on pregnancy planning and unmet need for contraception in the first postpartum year: a cohort study from rural Malawi.

BACKGROUND: The impact of depression on women's use of contraception and degree of pregnancy planning in low-income settings has been poorly researched. Our study aims to explore if symptoms of depression at preconception are associated with unplanned pregnancy and nonuse of contraception at the point of conception and in the postpartum period. METHODS: Population-based cohort of 4244 pregnant women in rural Malawi were recruited in 2013 and were followed up at 28 days, 6 months and 12 months postpartum. Women were asked about symptoms of depression in the year before pregnancy and assessed for depression symptoms at antenatal interview using the Self-Reporting Questionnaire-20, degree of pregnancy planning using the London Measure of Unplanned Pregnancy and use of contraception at conception and the three time points postpartum. RESULTS: Of the 3986 women who completed the antenatal interview, 553 (13.9%) reported depressive symptoms in the year before pregnancy and 907 (22.8%) showed current high depression symptoms. History of depression in the year before pregnancy was associated with inconsistent use of contraception at the time of conception [adjusted relative risk (adjRR) 1.52; 95% confidence interval (1.24-1.86)] and higher risk of unplanned [adjRR 2.18 (1.73-2.76)] or ambivalent [adj RR 1.75 (1.36-2.26)] pregnancy. At 28 days post-partum it was also associated with no use of contraception despite no desire for a further pregnancy [adjRR 1.49 (1.13-1.97)] as well as reduced use of modern contraceptives [adj RR 0.74 (0.58-0.96)]. These results remained significant after adjusting for socio-demographic factors known to impact on women's access and use of family planning services, high depression symptoms at antenatal interview as well as disclosure of interpersonal violence. Although directions and magnitudes of effect were similar at six and 12 months, these relationships were not statistically significant. CONCLUSIONS: Depression in the year before pregnancy impacts on women's use of contraception at conception and in the early postpartum period. This places these women at risk of unplanned pregnancies in this high fertility, high unmet need for contraception cohort of women in rural Malawi. Our results call for higher integration of mental health care into family planning services and for a focus on early postnatal contraception.

Family planning programmes have traditionally focused on increasing access to modern contraceptive methods. There is growing evidence that merely increasing access will not reach every woman. More focus on improving the quality of the family planning programmes and developing targeted interventions for women and men not currently reached with the current models is necessary. Despite the high prevalence of depression in women of reproductive age living in LMICs, its impact on women's access and use of contraception has been largely neglected. Our study using data from a cohort of pregnant women recruited in rural Malawi aimed to investigate if depression in the year before pregnancy impacted on women's risk of having an unintended pregnancy and on contraceptive use at time of pregnancy and in the postpartum period. Our results show that women who reported depression in the year before pregnancy had increased risk of inconsistent contraceptive use and having an unplanned pregnancy. They were also more likely to not use contraception in the early postpartum period and choose less effective methods, with important consequences for risk of subsequent unplanned pregnancies. Our results highlight a need for health services to develop holistic models of care for women where both their mental and reproductive health needs are met.

Predictive ability of the Desire to Avoid Pregnancy scale.

BACKGROUND: A longstanding gap in the reproductive health field has been the availability of a screening instrument that can reliably predict a person's likelihood of becoming pregnant. The Desire to Avoid Pregnancy Scale is a new measure; understanding its sensitivity and specificity as a screening tool for pregnancy as well as its predictive ability and how this varies by socio-demographic factors is important to inform its implementation. METHODS: This analysis was conducted on a cohort of 994 non-pregnant participants recruited in October 2018 and followed up for one year. The cohort was recruited using social media as well as advertisements in a university, school, abortion clinic and outreach sexual health service. Almost 90% of eligible participants completed follow-up at 12 months; those lost to follow-up were not significantly different on key socio-demographic factors. We used baseline DAP score and a binary variable of whether participants experienced pregnancy during the study to assess the sensitivity, specificity, area under the ROC curve (AUROC) and positive and negative predictive values (PPV and NPV) of the DAP at a range of cut-points. We also examined how the predictive ability of the DAP varied according to socio-demographic factors and by the time frame considered (e.g., pregnancy within 3, 6, 9 and 12 months). RESULTS: At a cut-point of 2 on the 0-4 range of the DAP scale, the DAP had a sensitivity of 0.78, a specificity of 0.81 and an excellent AUROC of 0.87. In this sample the cumulative incidence of pregnancy was 16% (95%CI 13%, 18%) making the PPV 43% and the NPV 95% at this cut-point. The DAP score was the factor most strongly associated with pregnancy, even after age and number of children were taken into account. The association between baseline DAP score and pregnancy did not differ across time frames. CONCLUSIONS: This is the first study to assess the DAP scale as a screening tool and shows that its predictive ability is superior to the limited pre-existing pregnancy prediction tools. Based on our findings, the DAP could be used with a cut-point selected according to the purpose.