SAGES guidelines for the use of laparoscopy during pregnancy.

BACKGROUND: When pregnant patients present with nonobstetric pathology, the physicians caring for them may be uncertain about the optimal management strategy. The aim of this guideline is to develop evidence-based recommendations for pregnant patients presenting with common surgical pathologies including appendicitis, biliary disease, and inflammatory bowel disease (IBD). METHODS: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Guidelines Committee convened a working group to address these issues. The group generated five key questions and completed a systematic review and meta-analysis of the literature. An expert panel then met to form evidence-based recommendations according to the Grading of Recommendations Assessment, Development, and Evaluation approach. Expert opinion was utilized when the available evidence was deemed insufficient. RESULTS: The expert panel agreed on ten recommendations addressing the management of appendicitis, biliary disease, and IBD during pregnancy. CONCLUSIONS: Conditional recommendations were made in favor of appendectomy over nonoperative treatment of appendicitis, laparoscopic appendectomy over open appendectomy, and laparoscopic cholecystectomy over nonoperative treatment of biliary disease and acute cholecystitis specifically. Based on expert opinion, the panel also suggested either operative or nonoperative treatment of biliary diseases other than acute cholecystitis in the third trimester, endoscopic retrograde cholangiopancreatography rather than common bile duct exploration for symptomatic choledocholithiasis, applying the same criteria for emergent surgical intervention in pregnant and non-pregnant IBD patients, utilizing an open rather than minimally invasive approach for pregnant patients requiring emergent surgical treatment of IBD, and managing pregnant patients with active IBD flares in a multidisciplinary fashion at centers with IBD expertise.

Public perspectives on inequality and mental health: A peer research study.

INTRODUCTION: Associations between structural inequalities and health are well established. However, there is limited work examining this link in relation to mental health, or that centres public perspectives. This study explores people's experience and sense-making of inequality in their daily lives, with particular consideration of impacts on mental health. METHODS: We conducted a peer research study. Participants had to live in one of two London Boroughs and have an interest in inequalities and mental health. Using social media, newsletters, local organisations and our peer researchers' contacts, we recruited 30 participants who took photos representing their experience of inequality and discussed them during semi-structured interviews. Data were analysed using reflexive thematic analysis. RESULTS: Three themes were identified in this study: (1) inequalities are unjust, multilayered and intertwined with mental health. Accounts demonstrated a deep understanding of inequalities and their link to mental health outcomes, describing inequalities as 'suffering' and 'not good for anyone'. Financial, housing, immigration and healthcare problems exacerbated poor mental health, with racism, gender-based violence and job loss also contributing factors for both poor mental health and experiences of inequality; (2) inequalities exclude and have far-reaching mental health consequences, impacting personal sense of belonging and perceived societal value and (3) moving forwards-addressing long-standing inequality and poor public mental health necessitated coping and resilience strategies that are often unacknowledged and undervalued by support systems. CONCLUSION: Lived experience expertise was central in this study, creating an innovative methodological approach. To improve public mental health, we must address the everyday, painful structural inequalities experienced by many as commonplace and unfair. New policies and strategies must be found that involve communities, redistributing resources and power, building on a collective knowledge base, to coproduce actions combatting inequalities and improving population mental health. PATIENT OR PUBLIC CONTRIBUTION: This study was peer-led, designed and carried out by researchers who had experiences of poor mental health. Six authors of the paper worked as peer researchers on this study.

How co-locating public mental health interventions in community settings impacts mental health and health inequalities: a multi-site realist evaluation.

BACKGROUND: Public mental health interventions are non-clinical services that aim to promote wellbeing and prevent mental ill health at the population level. In England, the health, social and community system is characterised by complex and fragmented inter-sectoral relationships. To overcome this, there has been an expansion in co-locating public mental health services within clinical settings, the focus of prior research. This study evaluates how co-location in community-based settings can support adult mental health and reduce health inequalities. METHODS: A qualitative multi-site case study design using a realist evaluation approach was employed. Data collection took place in three phases: theory gleaning, parallel testing and refining of theories, and theory consolidation. We collected data from service users (n = 32), service providers (n = 32), funders, commissioners, and policy makers (n = 11), and members of the public (n = 10). We conducted in-depth interviews (n = 65) and four focus group discussions (n = 20) at six case study sites across England, UK, and two online multi-stakeholder workshops (n = 20). Interview guides followed realist-informed open-ended questions, adapted for each phase. The realist analysis used an iterative, inductive, and deductive data analysis approach to identify the underlying mechanisms for how community co-location affects public mental health outcomes, who this works best for, and understand the contexts in which co-location operates. RESULTS: Five overarching co-location theories were elicited and supported. Co-located services: (1) improved provision of holistic and person-centred support; (2) reduced stigma by creating non-judgemental environments that were not associated with clinical or mental health services; (3) delivered services in psychologically safe environments by creating a culture of empathy, friendliness and trust where people felt they were being treated with dignity and respect; (4) helped to overcome barriers to accessibility by making service access less costly and more time efficient, and (5) enhance the sustainability of services through better pooling of resources. CONCLUSION: Co-locating public mental health services within communities impacts multiple social determinants of poor mental health. It has a role in reducing mental health inequalities by helping those least likely to access services. Operating practices that engender inter-service trust and resource-sharing are likely to support sustainability.

Diagnosis of Pulmonary Embolism in Pregnancy.

Pulmonary embolism (PE) is a significant cause of obstetric morbidity and mortality. However, overdiagnosis related to excessive use of diagnostic testing is also associated with long-term major health issues, including impact on future pregnancies and subsequent health care. Accurate diagnosis of PE depends on the knowledge of prevalence of PE in the pregnant population, the a priori probability of a PE based on specific findings in a given patient, and understanding of the accuracy of computed tomography pulmonary angiography (CTPA), the dominant diagnostic modality employed for this diagnosis. Venous thromboembolism is widely considered to be more common in pregnancy. However, this term includes both deep venous thrombosis as well as PE. While the former appears to be more common, published data on the prevalence of PE in pregnancy show little or no increase relative to the general population. Given the published data on the sensitivity and specificity of CTPA, a positive reading is more likely to be a false positive unless the probability of a PE in a given patient is at least 5% (a 200-fold increase from baseline). Doubling the probability to 10% (a 400-fold increase) only improves the positive predictive value to approximately 67%. Strategies to refine the a priori probability of a PE in a given patient are detailed, including scoring systems and D-dimer measurements. A careful history and physical examination and thoughtful development of a differential diagnosis are key elements of clinical practice and should include both the likelihood of each possible diagnosis and the accuracy of diagnostic modalities. This approach should precede the application of a given algorithm. Such a structured approach can decrease utilization and limit false positive diagnoses without increasing morbidity or mortality. KEY POINTS: · Incidence of PE is lower than assumed.. · Incidence is critical for assessing predictive value of a test.. · Computed tomography angiography is likely overused in pregnancy.. · Clinical scoring and D-dimer have a role in PE diagnosis..

The understanding, application and influence of complexity in national physical activity policy-making.

BACKGROUND: Complexity theory and systems-thinking are increasingly popular in physical activity (PA) research and policy discourse. The impact of this perspective shift, across many sectors, may be underwhelming. We explore why, by focusing on how these concepts are understood and applied by PA policy-makers. This is of particular interest given the challenges of multisectoral interest and poorly defined stakeholder boundaries that are associated with PA promotion. In this study, we critique key elements of complexity theory and consider how it is understood and put into practice in PA policy-making. METHODS: We adopted a complex realist position. Ten semi-structured interviews were conducted with national-level policy-makers from United Kingdom government settings (five civil servants, three politicians, two policy advisors). An inductive thematic analysis was conducted, and managed with NVivo 10 software. RESULTS: Three overarching themes were constructed to reflect policy-makers' uncertainty about complexity and the application of such perspectives to this policy space, their sense that PA was an unexceptionable yet unclaimed policy issue, and their desire for influence and change. Participants discussed complexity in contrasting ways. Its meaning was context-dependent and dynamic, which generated uncertainty about applying the concept. Participants also perceived an increasingly diverse but ill-defined PA policy system that spans the domains of expertise and responsibility. Collaborative practices may contribute to a previously unobserved sense of detachment from the systems' complexity. Nevertheless, participants suggested potentially effective ways to stimulate system change, which require passionate and enterprising leadership, and included varied evidence use, a focus on localised implementation and different ways to connect people. CONCLUSIONS: This research highlighted the importance of extending complexity theory and systems-thinking. While emphasizing the prevalence of these ideas across the PA sector, there is uncertainty as to their meaning and implications. This may prevent their use in ways that enhance PA policies and programmes. Participants conceptualised PA as a tool, which was imposed on the system. While this may support participative decision-making and localised implementation, further research is needed to understand how local systems foster leadership, the practical application of complexity and systems-thinking, and how to support system-wide change in the development and implementation of PA policies.

The Physical Activity Messaging Framework (PAMF) and Checklist (PAMC): International consensus statement and user guide.

Effective physical activity messaging plays an important role in the pathway towards changing physical activity behaviour at a population level. The Physical Activity Messaging Framework (PAMF) and Checklist (PAMC) are outputs from a recent modified Delphi study. This sought consensus from an international expert panel on how to aid the creation and evaluation of physical activity messages. In this paper, we (1) present an overview of the various concepts within the PAMF and PAMC, (2) discuss in detail how the PAMF and PAMC can be used to create physical activity messages, plan evaluation of messages, and aid understanding and categorisation of existing messages, and (3) highlight areas for future development and research. If adopted, we propose that the PAMF and PAMC could improve physical activity messaging practice by encouraging evidence-based and target population-focused messages with clearly stated aims and consideration of potential working pathways. They could also enhance the physical activity messaging research base by harmonising key messaging terminologies, improving quality of reporting, and aiding collation and synthesis of the evidence.

Timing of Repeat Cesarean Delivery for Women with a Prior Classical Incision.

OBJECTIVE: This study aimed to compare neonatal outcomes for delivery at 36 weeks compared with 37 weeks in women with prior classical cesarean delivery (CCD). STUDY DESIGN: This was a secondary analysis of the prospective observational cohort of the Eunice Kennedy National Institute for Child and Human Development's Maternal-Fetal Medicine Unit Network Cesarean Registry. Data on cases of repeat cesarean delivery (RCD) in the setting of a prior CCD were abstracted and used for analysis. This study compared outcomes of women who delivered at 360/7 to 366/7 versus 370/7 to 376/7 weeks. The primary outcome was a composite of adverse neonatal outcomes that included neonatal intensive care unit (NICU) admission, respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN), hypoglycemia, mechanical ventilation, sepsis, length of stay ≥5 days, and neonatal death. A composite of maternal outcomes that included uterine rupture, blood transfusion, general anesthesia, cesarean hysterectomy, venous thromboembolism, maternal sepsis, intensive care unit admission, and surgical complications was also evaluated. RESULTS: There were 436 patients included in the analysis. Women who delivered at 36 weeks (n = 176) were compared those who delivered at 37 weeks (n = 260). There were no differences in baseline characteristics. Delivery at 37 weeks was associated with a reduction in composite neonatal morbidity (24 vs. 34%, adjusted odds ratio [aOR] = 0.61 [0.31-0.94]), including a decrease in NICU admission rates (20 vs. 29%, aOR = 0.63 [0.40-0.99]), hospitalization ≥5 days (13 vs. 24%, aOR = 0.48 [0.29-0.8]), and RDS or TTN (9 vs. 19%, aOR = 0.43 [0.24-0.77]). There was no difference in adverse maternal outcomes (7 vs. 7%, aOR = 0.98 [0.46-2.09]). CONCLUSION: Delivery at 37 weeks for women with a history of prior CCD is associated with a decrease in adverse neonatal outcomes, compared with delivery at 36 weeks. KEY POINTS: · Classical cesarean section may have increased risk of uterine rupture in future pregnancies.. · This study compares outcomes of delivery at 370/7 to 376/7 versus 360/7 to 366/7 weeks.. · Delivery at 370/7 to 376/7 weeks was associated with decreased neonatal morbidity..

Is It Safe to Manage Acute Cholecystitis Nonoperatively During Pregnancy?: A Nationwide Analysis of Morbidity According to Management Strategy.

OBJECTIVES: To compare cholecystectomy (CCY) and nonoperative treatment (no-CCY) for acute cholecystitis in pregnancy. SUMMARY OF BACKGROUND DATA: Current Society of Gastrointestinal and Endoscopic Surgery guidelines recommend CCY over nonoperative management of acute cholecystitis during pregnancy, and the American College of Obstetricians and Gynecologists recommend medically necessary surgery regardless of trimester. This approach has been recently questioned. METHODS: Pregnant women admitted with acute cholecystitis were identified using the Nationwide Readmission Database 2010-2015. Propensity-score adjusted logistic regression models were used to compare CCY and no-CCY. The primary outcome was a composite measure of adverse maternal-fetal outcomes (intrauterine death/stillbirth, poor fetal growth, abortion, preterm delivery, C-section, obstetric bleeding, infection of the amniotic fluid, venous thromboembolism). RESULTS: There were 6390 pregnant women with acute cholecystitis: 38.2% underwent CCY, of which 5.1% were open. Patients were more likely to be managed operatively in their second trimester (First 43.9%, Second 59.1%, Third 34.2%; P < 0.01). Patients managed with CCY did not differ in age, insurance, income, Charlson Comorbidity Index, diabetes or obesity when compared to no-CCY (all P > 0.05), but were less likely to have a previous C-section, gestational diabetes, preeclampsia/eclampsia or be in the third trimester (P ≤ 0.01). Risk-adjusted analyses showed that no-CCY was associated with significantly increased maternal-fetal complications during the index admission [odds ratio 3.0 (95% confidence interval 2.08-4.34), P < 0.01] and 30-day readmissions [odds ratio 1.61 (confidence interval % CI 1.12-2.32), P < 0.01]. CONCLUSIONS: Contrary to current guidelines, most pregnant women admitted in the US with acute cholecystitis are managed nonoperatively. This is associated with over twice the odds of maternal-fetal complications in addition to increased readmissions.

A modified Delphi study to gain consensus for a taxonomy to report and classify physical activity referral schemes (PARS).

BACKGROUND: Physical Activity Referral Schemes (PARS), including exercise referral schemes, are a popular approach to health improvement, but understanding of effectiveness is limited by considerable heterogeneity in reporting and evaluation. We aimed to gain consensus for a PARS taxonomy as a comprehensive method for reporting and recording of such schemes. METHODS: We invited 62 experts from PARS policy, research and practice to complete a modified Delphi study. In round one, participants rated the need for a PARS taxonomy, the suitability of three proposed classification levels and commented on proposed elements. In round two, participants rated proposed taxonomy elements on an 11-point Likert scale. Elements scoring a median of ≥7, indicating high agreement, were included in the final taxonomy. RESULTS: Of those invited, 47 (75.8%) participated in round one, with high retention in round two (n = 43; 91.5%). 42 were UK-based, meaning the resultant taxonomy has been scrutinised for fit to the UK context only. The study gained consensus for a three-level taxonomy: Level 1: PARS classification (primary classification, provider, setting, conditions accepted [have or at risk of], activity type and funding). Level 2: scheme characteristics (staff structure, staff qualifications, behaviour change theories, behaviour change techniques, referral source, referrers, referral process, scheme duration, session frequency, session length, session times, session type, exit routes, action in case of non-attendance, baseline assessment, exit assessment, feedback to referrer and exclusion criteria) and Level 3: participant measures (demographics, monitoring and evaluation, and measures of change). CONCLUSION: Using a modified Delphi method, this study developed UK-based consensus on a PARS classification taxonomy. We encourage PARS practitioners and public health colleagues, especially those working with similar service models internationally, to test, refine and use this taxonomy to inform policy and practice.

Tenascin-X in amniotic fluid and reproductive tissues of pregnancies complicated by infection and preterm prelabor rupture of membranes†.

Preterm prelabor rupture of membranes (PPROM), which can precede or follow intra-amniotic infection/inflammation (IAI), is a poorly understood pregnancy complication. Tenascin-X (TNX) is a connective tissue extracellular matrix protein that regulates fibrillogenesis of collagens I, III, and V. Our goal was to investigate the presence and level of soluble TNX (sTNX) in amniotic fluid (AF) and TNX expression in reproductive tissues of pregnancies complicated by PPROM and IAI. We prospectively recruited 334 women pregnant with singletons who had a clinically indicated amniocentesis for genetic karyotyping, lung maturity testing, or rule-out IAI in the presence or absence of PPROM. We quantified TNX expression in fetal membranes, myometrium, cervix, and placenta using immunological methods and qRT-PCR. In pregnancies with normal outcomes, AF sTNX levels were GA-regulated with lower levels toward term. IAI significantly upregulated AF sTNX levels independent of membrane status. AF sTNX levels inversely correlated with fetal membranes tenascin XB (TNXB) mRNA level, which was significantly downregulated by IAI. Western blotting identified characteristic ∼75 and ∼140 kDa sTNX forms in both AF and fetal membranes. Fetal membranes, placenta, and cervix constitutively express TNX with the highest abundance in the amnion. Amnion TNX richness is significantly lost in the setting of IAI. Our results suggest that fetal membranes may be a source of AF sTNX whereby protein and mRNA expression seem to be significantly impacted by inflammation independent of fetal membrane status. A more thorough understanding of TNX changes may be valuable for understanding spontaneous PPROM and to potentially develop therapeutic targets.

Seven-year itch: the UK Government's difficult relationship with the food and drink industry since Healthy Lives, Healthy People: A Call to Action on Obesity in England (2011).

OBJECTIVE: Unhealthy food and drink consumption is associated with a range of physical and mental health concerns. In response, public health policies have been developed targeting a reduction in obesity in particular. In the present commentary we argue that government-industry partnerships have reduced the effectiveness of resultant policies and explore why. DESIGN: Perspectives of authors. SETTING: UK.ParticipantsPopulations in the UK; UK Government. RESULTS: Industry involvement has presented three interrelated challenges for the UK Government: (i) balancing collaboration while maintaining appropriate distance from industry stakeholders; (ii) resultant production of 'watertight' and effective legislation or intervention; and (iii) actual or perceived limited sanctioning or bargaining power. CONCLUSIONS: Industry involvement in public health policy making has led to weak action. Support with policy implementation (rather than development) and genuine 'buy-in' from industry could accelerate the pace of public health improvement.

Acceptability and Feasibility of Implementing Accelorometry-Based Activity Monitors and a Linked Web Portal in an Exercise Referral Scheme: Feasibility Randomized Controlled Trial.

BACKGROUND: Exercise referral schemes (ERSs) are recommended for patients with health conditions or risk factors. Evidence points to the initial effectiveness and cost-effectiveness of such schemes for increasing physical activity, but effects often diminish over time. Techniques such as goal setting, self-monitoring, and personalized feedback may support motivation for physical activity and maintenance of effects. Wearable technologies could provide an opportunity to integrate motivational techniques into exercise schemes. However, little is known about acceptability to exercise referral populations or implementation feasibility within exercise referral services. OBJECTIVE: To determine the feasibility and acceptability of implementing an activity-monitoring device within the Welsh National ERS to inform a decision on whether and how to proceed to an effectiveness trial. METHODS: We conducted a feasability randomized controlled trial with embedded mixed-methods process evaluation and an exploratory economic analysis. Adults (N=156) were randomized to intervention (plus usual practice; n=88) or usual practice only (n=68). Usual practice was a 16-week structured exercise program. The intervention group additionally received an accelerometry-based activity monitor (MyWellnessKey) and associated Web platform (MyWellnessCloud). The primary outcomes were predefined progression criteria assessing acceptability and feasibility of the intervention and proposed evaluation. Postal questionnaires were completed at baseline (time 0:T0), 16 weeks (T1), and 12 months after T0 (T2). Routine data were accessed at the same time-points. A subsample of intervention participants and scheme staff were interviewed following the initiation of intervention delivery and at T2. RESULTS: Participants were on average aged 56.6 (SD 16.3) years and mostly female (101/156, 64.7%) and white (150/156, 96.2%). Only 2 of 5 progression criteria were met; recruitment and randomization methods were acceptable to participants, and contamination was low. However, recruitment and retention rates (11.3% and 67.3%, respectively) fell substantially short of target criteria (20% and 80%, respectively), and disproportionally recruited from the least deprived quintile. Only 57.4% of intervention participants reported receipt of the intervention (below the 80% progression threshold). Less than half reported the intervention to be acceptable at T2. Participant and staff interviews revealed barriers to intervention delivery and engagement related to the device design as well as context-specific technological challenges, all of which made it difficult to integrate the technology into the service. Routinely collected health economic measures had substantial missing data, suggesting that other methods for collecting these should be used in future. CONCLUSIONS: To our knowledge, this is the first study to evaluate short- and long-term feasibility and acceptability of integrating wearable technologies into community-based ERSs. The findings highlight device- and context-specific barriers to doing this in routine practice, with typical exercise referral populations. Key criteria for progression to a full-scale evaluation were not met. TRIAL REGISTRATION: ISRCTN Registry ISRCTN85785652; http://www.isrctn.com/ISRCTN85785652.

Patterns of Empiric Antibiotic Administration for Presumed Early-Onset Neonatal Sepsis in Neonatal Intensive Care Units in the United States.

Objective To evaluate current patterns in empiric antibiotic use for early-onset neonatal sepsis (EONS). Study Design Retrospective population-based cohort study of newborns admitted on postnatal day 0 to 1 and discharged from NICUs participating in the Pediatric Health Information System (PHIS 2006-2013). Analyses included frequency of antibiotic initiation within 3 days of birth, duration of first course, and variation among hospitals. Results Of 158,907 newborns, 118,624 (74.7%) received antibiotics on or before postnatal day 3. Within 3 days of treatment, 49.4% (n = 58,610) were discharged home or remained hospitalized without antibiotics. There was marked interhospital variation in the proportion of infants receiving antibiotics (range: 52.3-90.9%, mean 77.9%, SD 11.0%) and in treatment days (range: 3.2-8.6, mean 5.3, SD 1.4). Facilities with higher number of newborns started on antibiotics had longer courses (r = 0.643, p < 0.001). The cost of admissions for infants born at ≥35 weeks started on antibiotics and discharged home after no more than 3 days of antibiotics was $76,692,713. Conclusion Site variation in antibiotic utilization suggests antibiotic overtreatment of infants with culture unconfirmed EONS is common and costly.

Swa2, the yeast homolog of mammalian auxilin, is specifically required for the propagation of the prion variant [URE3-1].

Yeast prions require a core set of chaperone proteins including Sis1, Hsp70 and Hsp104 to generate new amyloid templates for stable propagation, yet emerging studies indicate that propagation of some prions requires additional chaperone activities, demonstrating chaperone specificity beyond the common amyloid requirements. To comprehensively assess such prion-specific requirements for the propagation of the [URE3] prion variant [URE3-1], we screened 12 yeast cytosolic J-proteins, and here we report a novel role for the J-protein Swa2/Aux1. Swa2 is the sole yeast homolog of the mammalian protein auxilin, which, like Swa2, functions in vesicle-mediated endocytosis by disassembling the structural lattice formed by the protein clathrin. We found that, in addition to Sis1, [URE3-1] is specifically dependent upon Swa2, but not on any of the 11 other J-proteins. Further, we show that [URE3-1] propagation requires both a functional J-domain and the tetratricopeptide repeat (TPR) domain, but surprisingly does not require Swa2-clathrin binding. Because the J-domain of Swa2 can be replaced with the J-domains of other proteins, our data strongly suggest that prion-chaperone specificity arises from the Swa2 TPR domain and supports a model where Swa2 acts through Hsp70, most likely to provide additional access points for Hsp104 to promote prion template generation.

High Mobility Group-Box 1 (HMGB1) levels are increased in amniotic fluid of women with intra-amniotic inflammation-determined preterm birth, and the source may be the damaged fetal membranes.

BACKGROUND: High Mobility Group Box-1 (HMGB1) is considered a prototype alarmin molecule. Upon its extracellular release, HMGB1 engages pattern recognition receptors and the Receptor for Advanced Glycation End-products (RAGE) followed by an outpouring of inflammatory cytokines, including interleukin (IL)-6. METHODS: We assayed the amniotic fluid (AF) levels of HMGB1 and IL-6 in 255 women that either had a normal pregnancy outcome or delivered preterm. Immunohistochemistry on fetal membranes was used for cellular localization and validation of immunoassay findings. HMGB1 also was analyzed in amniochorion tissue explants subjected to endotoxin. RESULTS: AF HMGB1 levels are not gestational age regulated but are increased in women with intra-amniotic inflammation and preterm birth. The likely source is the damaged amniochorion, as demonstrated by immunohistochemistry and explant experiments. CONCLUSIONS: Our research supports a role for HMGB1 in the inflammatory response leading to preterm birth. As a delayed phase cytokine, in utero exposure to elevated AF HMGB1 levels may have an impact on the newborn beyond the time of birth.

Development and Validation of an Algorithm to Determine Spontaneous versus Provider-Initiated Preterm Birth in US Vital Records.

BACKGROUND: Determining whether initiation of preterm birth was spontaneous, or through labour induction or caesarean without labour or membrane rupture is critical in surveillance and aetiological research on preterm birth, although this information is not explicitly included on the US Birth Certificate. Algorithms combining several fields from birth certificates have been developed to infer the initiating event, but none has been validated against manual review of original obstetric records. Our objective was to develop a birth certificate-based algorithm to determine initiation of preterm birth and validate it by manual review of original records. METHODS: We developed an algorithm from the 2003 US Standard Birth Certificate to determine spontaneous vs. indicated preterm birth. The algorithm was first tested on obstetrical records from 80 preterm (<37 weeks) births in Columbus OH (2006-12) abstracted by an obstetrics research nurse and reviewed by an obstetrician-gynecologist. Onset of delivery was spontaneous if the initiating event was premature rupture of membranes (PROM) or contractions, or indicated if the initiating event was induction or caesarean without labour or PROM. The algorithm was validated in an independent sample of 100 preterm births from four hospitals. RESULTS: Codes for tocolysis, fetal intolerance of labour, and anaesthesia during labour did not predict labour and were dropped. The final algorithm correctly classified 73/80 cases, kappa = 0.83. In the validation, 86/100 cases were correctly classified. The kappa statistic was 0.68 (0.52, 0.83); predictive values for spontaneous and indicated onset were 85% (75%, 92%) and 89% (71%, 98%). CONCLUSIONS: The algorithm distinguished spontaneous from indicated preterm birth, using birth certificates, with good accuracy.