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Supplementary Information | The online version contains supplementary material available at 10.1186/s12879-023-08297-7. | PMC10594805 | ||
Keywords | PMC10594805 | |||
Background | death, VTE, respiratory syndrome, bleeding | CORONAVIRUS DISEASE 19, BLEEDING, ARTERIAL THROMBOSIS | Governments and health official worldwide are still facing the challenge of the severe respiratory syndrome epidemic due to the Coronavirus Disease 19 (COVID-19) [Studies in ICU patients, such as the INSPIRATION trial, showed no benefit of intermediate doses of LMWH when compared with standard-dose prophylaxis, on the ... | PMC10594805 |
Methods | PMC10594805 | |||
Experimental design | A non-randomized parallel assignment study was conducted with two arms: a phase II single-arm interventional study including all patients treated with the study drug and an observational cohort including all patients screened for receiving the study drug but not included in the phase II study. | PMC10594805 | ||
Objectives | The primary objective was to analyze the safety of intermediate weight adjusted enoxaparin in hospitalized patients with moderate-severe COVID-19. Secondary objective was to investigate the efficacy of intermediate weight adjusted enoxaparin in improving the clinical outcome of hospitalized patients with moderate-sever... | PMC10594805 | ||
Setting | The study INHIXACOVID19 was conducted in 13 Italian centers (see Supplementary Table | PMC10594805 | ||
Study population | bleeding, arteriovenous malformations, vascular aneurysms, malignant tumors, venous thromboembolism, hypersensitivity | BLEEDING, HEMORRHAGIC STROKE, DISEASE, COVID-19 INFECTION, MALIGNANT TUMORS, PEPTIC ULCER, COAGULOPATHY, HEPARIN INDUCED THROMBOCYTOPENIA, ATRIAL FIBRILLATION, HYPERSENSITIVITY, IMPAIRED RENAL FUNCTION | The same inclusion and exclusion criteria were applied for patients included either in the interventional or in the observational arms. Inclusion criteria were: age > = 18 y; hospital admission; microbiologically confirmed COVID-19 infection; moderate-severe disease according to study definitions (see below); and abil... | PMC10594805 |
Clinical severity definitions | respiratory failure, pneumonia, fever | RESPIRATORY FAILURE, PNEUMONIA, MULTIPLE ORGAN FAILURE, SEPTIC SHOCK | Clinical severity of COVID-19 was assessed at the time of diagnosis, during the treatment with the study drug, and at the end of treatment according to the following criteria [Mild: only mild symptoms without radiographic featuresModerate: fever, respiratory symptoms, and radiographic signs of pneumoniaSevere: fever, r... | PMC10594805 |
Treatments | EMA | Patients included in the observational cohort received standard thromboprophylaxis with enoxaparin 40 mg od, while patients included in the interventional cohort received subcutaneous enoxaparin in a single daily dose of:60 mg (body weight of 45–60 kg)80 mg (body weight of 61–100 kg)100 mg (body weight > 100 kg)The int... | PMC10594805 | |
Laboratory tests | VIRUS, HEPARIN INDUCED THROMBOCYTOPENIA | After reaching the steady state (usually after the third dose), heparin levels were measured with the determination of anti-Xa activity on a blood sample obtained at 4 h after the morning injection. LMWH dose could then be increased or reduced according anti-FXa (anti-Xa) activity (0.4–0.6 anti-Xa UI/ml for intermediat... | PMC10594805 | |
Follow-up | Follow-up was 90 days after study drug initiation. Follow-up information was collected via telephone calls, patient medical records and/or clinical visits according to clinical evolution. | PMC10594805 | ||
Outcomes | pulmonary embolism, stroke, bleeding | PULMONARY EMBOLISM, ACUTE MYOCARDIAL INFARCTION, BLEEDING, THROMBOEMBOLIC EVENT, DEEP VEIN THROMBOSIS (DVT), ADVERSE EVENTS, STROKE, COMPLICATIONS | Primary outcome was the rate of adverse events (AEs) in particular bleeding complications during treatment, at the end of treatment (EOT) and at 30 days after EOT, and occurrence of thromboembolic event at 90 days after COVID-19 diagnosis. Symptomatic thromboembolic events were objectively confirmed deep vein thrombosi... | PMC10594805 |
Outcome assessment | thromboembolic, death, bleeding | EVENTS, BLEEDING | The cause of death was evaluated by an independent adjudication safety committee. The evolution of the clinical severity during treatment was assessed by the attending physician. All outcomes related to thromboembolic and bleeding events were assessed by an independent adjudication safety committee with an interim safe... | PMC10594805 |
Sample size determination | This was a pilot study and an initial sample of 100 patients for the phase II single-arm interventional trial was established. | PMC10594805 | ||
Statistical analyses | Binary variables, such as the presence/absence of a given underlying condition, were reported as raw number and prevalence rates along with the | PMC10594805 | ||
Results | PMC10594805 | |||
Analysis of safety | Bleeding, bleeding, venous thrombosis | PULMONARY EMBOLISM, BLEEDING, THROMBOEMBOLIC EVENT, BLEEDING, EVENTS, VENOUS THROMBOSIS | The bleeding events within 30 days were 5.4% and 0.5% in the interventional and in the observational arms (Bleeding and thromboembolic events in the interventional and observational cohortsAt 30 days, four patients in the observational cohort had a thromboembolic event; of these two were venous thrombosis and two were ... | PMC10594805 |
Analysis of efficacy | hypertension, COPD, diabetes | DISEASE, COPD, EVENTS, HYPERTENSION, DIABETES | Crude comparison of outcome variables between interventional and observational arms are shown in supplementary Table To account for differences in the two groups, a propensity score matching algorithm was done identifying a match for 90 patients both in the interventional and observational cohort, based on age, gender,... | PMC10594805 |
Discussion | bleeding, thromboembolic, DVT, thrombotic, VTE | BLEEDING, MINOR, EVENT, DEEP VEIN THROMBOSES, ADVERSE EVENT, BLIND, EVENTS, COMPLICATIONS, DVT | This phase II pilot study showed that thromboprophylaxis with intermediate dose heparin with anti-FXa monitoring in patients with moderate or severe COVID-19 and moderately increased D-dimer was not associated with a higher risk of major bleeding compared to patients receiving standard dose prophylaxis. Indeed, there w... | PMC10594805 |
Conclusions | BLEEDING | Intermediate dose heparin with anti-Factor Xa monitoring in patients with moderate or severe COVID-19 and moderately increased D-dimer was not associated with an increased risk of major bleeding. Our data seems to suggest a more favorable clinical course and shorter length of hospitalization in patients treated with in... | PMC10594805 | |
Authors’ contributions | P. | B. Cosmi, F. Drago, M. Giannella, A. Stella and P. Viale designed the study, managed and coordinated responsibility for research activity planning and execution and wrote the draft; A. Romagnoli managed activities to annotate (produce metadata), scrub data and maintain research data (including software code, where it i... | PMC10594805 | |
Funding | No funding. | PMC10594805 | ||
Availability of data and materials | The datasets generated and/or analysed during the current study are not publicly available due to local privacy policy but are available from the corresponding author on reasonable request. | PMC10594805 | ||
Declarations | PMC10594805 | |||
Ethics approval and consent to participate | INFECTIOUS DISEASES | The study was approved by the Ethics Committee of the Lazzaro Spallanzani National Institute for Infectious Diseases of Rome which has been attributed the role of National Ethics Committee for assessing clinical trials on medicines for human use and medical devices for patients with COVID-19 and by the Italian Drug Age... | PMC10594805 | |
Consent for publication | Not applicable. | PMC10594805 | ||
Competing interests | Werfen; A. Castagna | EVENTS | B. Cosmi received speakers honoraria by Sanofi, Werfen IL, fees for advisory board from Viatris and Techdow Pharma Italy; E. Grandone received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Sanofi, ItalFarmaco, Rovi, Stago Werfen; A. Castagna received c... | PMC10594805 |
References | PMC10594805 | |||
Key Points | PMC10509729 | |||
Question | Is use of artificial intelligence (AI) in a simulated surgical skills curriculum associated with unintended performance outcomes? | PMC10509729 | ||
Findings | tumor, tissue damage | TUMOR | This cohort study of 46 medical students and 14 experts found that the AI-enhanced simulation curriculum demonstrated significant unintended changes in 52 performance metrics outside the curriculum that were not observed in the control cohort. These unintended changes included significantly improved procedural safety (... | PMC10509729 |
Meaning | SECONDARY | This cohort study found that use of AI in designing a simulated surgical skills curriculum was associated with unintended learning outcomes, with both positive and negative consequences for learner competency, suggesting that intervention from human experts may be required to optimize educational goals.This cohort stud... | PMC10509729 | |
Importance | To better elucidate the role of artificial intelligence (AI) in surgical skills training requires investigations in the potential existence of a hidden curriculum. | PMC10509729 | ||
Objective | To assess the pedagogical value of AI-selected technical competencies and their extended effects in surgical simulation training. | PMC10509729 | ||
Design, Setting, and Participants | MAY, SECONDARY | This cohort study was a follow-up of a randomized clinical trial conducted at the Neurosurgical Simulation and Artificial Intelligence Learning Centre at the Montreal Neurological Institute, McGill University, Montreal, Canada. Surgical performance metrics of medical students exposed to an AI-enhanced training curricul... | PMC10509729 | |
Exposure | Performance assessment and personalized feedback by an intelligent tutor on 4 AI-selected learning objectives during simulation training. | PMC10509729 | ||
Main Outcomes and Measures | Outcomes of interest were unintended performance outcomes, measured by significant within-participant difference from baseline in 270 performance metrics in the intervention cohort that was not observed in the control cohort. | PMC10509729 | ||
Results | tumor | TUMOR | A total of 46 medical students (median [range] age, 22 [18-27] years; 27 [59%] women) and 14 surgeons (median [range] age, 45 [35-59] years; 14 [100%] men) were included in this study, and no participant was lost to follow-up. Feedback on 4 AI-selected technical competencies was associated with additional performance c... | PMC10509729 |
Conclusions and Relevance | In this cohort study of medical students, an AI-enhanced curriculum for bimanual surgical skills resulted in unintended changes that improved performance in safety but negatively affected some efficiency metrics. Incorporating AI in course design requires ongoing assessment to maintain transparency and foster evidence-... | PMC10509729 | ||
Introduction | In surgical education, technical competency is one of the key factors of efficacy in the curriculum, and it is an independent factor that is directly associated with postoperative patient outcomes.Simulation is an important component of competency-based medical education.In our previous work,To assess the pedagogical v... | PMC10509729 | ||
Methods | PMC10509729 | |||
Study Participants | SECONDARY | We conducted a planned secondary analysis using retrospective data from 2 previously conducted studies, a cohort study of 14 experts and a randomized clinical trial involving 46 medical students. In the first study, skilled consultants performed a simulated neurosurgical procedure with no feedback to establish expert b... | PMC10509729 | |
Study Procedure and Simulation | tumor | TUMOR | All participant performed 5 simulated neurosurgical tumor resection procedures within a fixed time and either received an intervention (VOA group) or no intervention (control and skilled groups) after the completion of each attempt. | PMC10509729 |
Performance Metric Extraction and Expertise Benchmarks | tumor | TUMOR | Raw data from the initial and final attempts were used to extract 270 assessment metrics for each procedure. These metrics were selected based on their ability to differentiate experts from novices and are equally divided into 3 groups depending on the state of the operation: during tumor resection, while suctioning bl... | PMC10509729 |
Statistical Analysis | Collected data were examined for normality with the Shapiro-Wilk test, and Wilcoxon rank test was used when | PMC10509729 | ||
Results | All 46 medical students (median [range] age, 22 [18-27] years; 27 [59%] women) and 14 surgeons (median [range] age, 45 [35-59] years; 14 [100%] men) completed the trial, and no one was lost to follow-up. Medical students were in the preclinical period of their studies (19 students [41%] in premedicine program; 16 stude... | PMC10509729 | ||
Demographic Characteristics of Participants | Abbreviations: AI, artificial intelligence; NA, not applicable.Range, 1 to 5, with higher scores indicating greater motivation to pursue a surgical specialty in postgraduate training.Participants in the VOA group responded successfully to performance feedback and achieved expert benchmarks in the curriculum’s learning ... | PMC10509729 | ||
Performance in the Learning Objectives of the Virtual Operative Assistant (VOA) Curriculum | tumor | TUMOR | The skilled group’s mean and SD in each metric are represented by the solid and dashed lines, respectively. Because the variables are recorded at a frequency of 50 Hz by the simulator, each unit of time (t) is equal to 20 ms. Error bars indicate 95% CIs.Damage to healthy brain tissue is an important safety metric in ne... | PMC10509729 |
Extended Associations of the Virtual Operative Assistant (VOA) Curriculum With Safety Competencies | tumor | TUMOR | The skilled group’s mean and SD in each metric are represented by the solid and dashed lines, respectively. Because the variables are recorded at a frequency of 50 Hz by the simulator, each unit of time (t) is equal to 20 ms. Error bars indicate 95% CIs.Two other important metrics of safety are maintaining a focused bi... | PMC10509729 |
Extended Associations of the Virtual Operative Assistant (VOA) Curriculum With Movement and Efficiency Metrics | tumor | TUMOR | The skilled group’s mean and SD in each metric are represented by the solid and dashed lines, respectively. Because the variables are recorded at a frequency of 50 Hz by the simulator, each unit of time (t) is equal to 20 ms. Error bars indicate 95% CIs.Finally, we looked at the rate of tumor resection over the entire ... | PMC10509729 |
Discussion | tumor, tissue damage | TUMOR | This cohort study is the first study to demonstrate unintended surgical skill acquisition with both positive and negative consequences following an AI-enhanced curriculum, to our knowledge. In the competency-based framework of postgraduate medical training, AI provides a tool to identify and teach quantifiable metrics ... | PMC10509729 |
Future Directions | ADVERSE EVENTS | With advancements in live intraoperative data acquisition for quality improvement, AI systems are believed to play a key role in mitigating adverse events and suggesting instructions in the operating room. | PMC10509729 | |
Limitations | This study has some limitations. One limitation is the number of surgeons in the skilled group and their range of experience in neuro-oncological surgery. However, most participants in the skilled group primarily practiced cranial neurosurgery, and subpial resection is a fundamental technique that is mastered throughou... | PMC10509729 | ||
Conclusion | This cohort study found that learning bimanual surgical skills in simulation with metric-specific instructions on AI-selected competencies was associated with unintended changes in other competency domains. These extrinsic outcomes had both positive and negative associations with learners’ expertise level compared with... | PMC10509729 | ||
Zora Kesich | (MPH) is a graduate of the Emory University Rollins School of Public Health, Department of Behavioral, Social, & Health Education Sciences; her focus areas include harm reduction, safer consumption, and qualitative methods. | PMC10636969 | ||
Umedjon Ibragimov | (PhD, MPH) is a Research Assistant Professor in the Emory University Rollins School of Public Health; his key research areas include structural determinants of HIV/AIDS and implementation of harm reduction services in the U.S. and globally. | PMC10636969 | ||
Kelli Komro | (PhD, MPH) is a Professor jointly appointed in the Rollins School of Public Health Department of Behavioral, Social, & Health Education Sciences and Department of Epidemiology; her focus areas include child and adolescent health and reducing health disparities driven by racial and economic inequities. | PMC10636969 | ||
Kenneth Lane | of the University of Kentucky College of Public Health Department of Epidemiology was a CARE2HOPE Project Coordinator and delivered intervention sessions to participants. | PMC10636969 | ||
Melvin Livingston | (PhD) is a Research Associate Professor in the Rollins School of Public Health Department of Behavioral, Social, & Health Education Sciences; his expertise is in the application of quasi-experimental design principles to the evaluation of community interventions and state policies. | PMC10636969 | ||
April Young | (PhD, MPH) is a Professor in the University of Kentucky College of Public Health in the Department of Epidemiology and a Faculty Associate with the Center on Drug and Alcohol Research; her expertise includes substance use, social network analysis, rural health, and community engagement. | PMC10636969 | ||
Hannah L. F. Cooper | DISORDER | (ScD) is the Rollins School of Public Health Chair in Substance Use Disorder Research and a Professor jointly appointed in the school’s Department of Behavioral, Social, & Health Education Sciences and Department of Epidemiology; her areas of expertise include studying the social determinants of drug-related harms, wit... | PMC10636969 | |
Background | Overdoses, Overdose, overdose | Overdoses have surged in rural areas in the U.S. and globally for years, but harm reduction interventions have lagged. Overdose education and naloxone distribution (OEND) programs reduce overdose mortality, but little is known about people who use drugs’ (PWUD) experience with these interventions in rural areas. Here, ... | PMC10636969 | |
Methods | Twenty-nine one-on-one, semi-structured qualitative interviews were conducted with rural PWUD engaged in the CARE2HOPE OEND intervention in Appalachian Kentucky. Interviews were conducted via Zoom, audio-recorded, and transcribed verbatim. Thematic analysis was conducted, guided by the Rural Risk Environment Framework. | PMC10636969 | ||
Results | overdose | Participants’ naloxone experiences were shaped by all domains of their rural risk environments. The OEND intervention transformed participants’ roles locally, so they became an essential component of the local rural healthcare environment. The intervention provided access to naloxone and information, thereby increasing... | PMC10636969 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12954-023-00900-z. | PMC10636969 | ||
Keywords | PMC10636969 | |||
Background | Overdose, overdose | EVENTS, EVENT | Overdose burden is elevated in the United States’ rural communities [Much of what we know about how PWUD perceive and engage with naloxone comes from studies in urban and suburban areas [While these studies provide valuable insight, there remain several areas for growth in this body of research. First, there is a pauci... | PMC10636969 |
Methods | PMC10636969 | |||
Overview & design | overdose | All participants in this sample were part of a parent study, This qualitative sub-study, nested within the larger C2H study described above, used in-depth, semi-structured interviews to explore participant perceptions of the intervention. The current analysis focuses on data relevant to perceptions of the OEND componen... | PMC10636969 | |
Sample & recruitment | arrest, overdose | RECRUITMENT, ARREST | Individuals were eligible for C2H if they lived in one of the Kentucky counties targeted by the study; were 18 years old or older; had been engaged in the criminal-legal system in the past 30 days prior to enrollment screening; and either used opioids to get high or injected drugs to get high 30 days prior to criminal ... | PMC10636969 |
Data collection | In-depth, semi-structured interviews were conducted with all participants between March 18th, 2022, and October 24th, 2022 ($30 honorarium, provided via a Western Union card). Interviews took place over a HIPAA-protected Zoom interface and lasted between 30 and 94 min. Participants without access to private space and/o... | PMC10636969 | ||
Ethics | The study was approved by the University of Kentucky IRB (#52439). Prior to all interviews, oral informed consent was obtained. All recordings, transcripts, and other study materials were stored on secure, password-protected devices. | PMC10636969 | ||
Results | The final sample for this study included 29 participants (see Table Results Visual Model | PMC10636969 | ||
Accessing/accepting naloxone | PMC10636969 | |||
Carrying naloxone | Approximately two-thirds (n = 19) of participants opted to carry naloxone at least some of the time. The C2H OEND impacted participants’ experiences of carrying naloxone by, (a) providing access to naloxone, (b) increasing participant confidence in their legal right to carry naloxone, (c) mitigating impact of police st... | PMC10636969 | ||
Safer with naloxone: “you never know when you can run into someone that is overdosing” | While interviewers did not directly query about perceived safety, several participants (n = 10) independently volunteered that despite potential consequences, they felt safer with naloxone than they did without it. No participants described feeling You can't ever tell in wherever you're at, what kind of situations goin... | PMC10636969 | ||
Helper role: “it feels good to have a part in something” | overdose | SAID | Regarding the “People would always come running to us when they would need [Narcan], when people would OD. We actually saved eight or nine, 10 lives. People would OD, we would be the ones to have the Narcan. Everywhere we go, we got Narcan. People we don't know, we have saved their lives with Narcan […] Just because we... | PMC10636969 |
Stigma and criminal-legal systems: “wear a badge, they think they’re better than everyone else” | overdose, arrest, trauma | ARREST | Stigma codified and perpetuated by law enforcement obstructed some participants’ comfort with carrying naloxone. Because all participants were criminal-legal system involved, relationships with law enforcement were rooted in prior conflict and experienced trauma. Several participants (n = 5) described law enforcement s... | PMC10636969 |
Administering naloxone | overdose | EVENT | Over half (n = 16) of participants described recent experience administering C2H-provided naloxone. Fourteen participants administered C2H-provided naloxone on someone else, one participant had C2H-provided naloxone administered on her, and one participant handed someone else the naloxone to administer to another indiv... | PMC10636969 |
Recipient reaction: “now they’re sober and they’re broke” | anger, overdose, adverse recipient reaction | WASTED, SAID | Participants expressed that when they used naloxone to reverse someone’s overdose, they were often met with anger and frustration upon the recipient’s revival. Participants offered various explanations for these reactions, including loss of high, acute withdrawal symptoms, and frustration of having spent limited funds ... | PMC10636969 |
Prior communication: “wait three minutes before you Narcan me” | Participants’ Another component of these conversations was the recipient’s communicated desire, or lack thereof, to receive naloxone. Participants described receiving or giving instructions to wait for a specified benchmark or time limit before administering naloxone. These conversations often involved one party’s inte... | PMC10636969 | ||
Discussion | overdose | This study qualitatively assessed the pathways through which risk environments influence how rural PWUD accept, carry, and administer naloxone, and the role of an OEND intervention on these experiences. Analyses found that the C2H OEND intervention altered some participants’ healthcare environments by providing access ... | PMC10636969 | |
Accessing/Accepting naloxone | Other studies conducted in non-rural settings identified For many participants, decisions to accept naloxone were predicated not only on understanding what naloxone was and learning about its effectiveness, but also on learning about protections offered by the state’s medical amnesty/Good Samaritan policies. These crim... | PMC10636969 | ||
Carrying naloxone | overdose | Previous studies conducted in both urban and rural areas identified feelings of purpose and empowerment [Our findings identified that participants’ rural physical environments often facilitated their desire to carry naloxone, highlighting the high prevalence of overdose in their community combined with slow emergency r... | PMC10636969 | |
Administering naloxone | Our findings highlight fear of disrupting someone’s high and fear of imposed economic loss as paired barriers to naloxone administration decisions. Previous studies in urban areas identified fear of recipient reaction and fear of disrupting someone’s high [ | PMC10636969 | ||
Strengths & limitations | overdose, fatigue | EVENTS, RECRUITMENT | Results of this study fill a gap in the literature regarding naloxone experiences of PWUD in rural Appalachian communities. Furthermore, our study explored the ways that PWUD discuss naloxone with their social networks, before, during, and after overdose events. This focus area yielded rich data, providing meaningful c... | PMC10636969 |
Conclusion | anger, overdose | EVENT | Factors that influence rural PWUDs’ decisions to accept, carry, and administer naloxone are complex and touch upon all domains of their rural risk environment. Our sample included participants who had never heard of naloxone or had gaps in their understanding of its effectiveness and/or how to administer it. The C2H in... | PMC10636969 |
Acknowledgements | Overdose, overdose | RECRUITMENT | We are grateful to KORE (Kentucky Overdose Response Effort) for providing naloxone to the project. We are grateful Dr. Patricia Freeman for creating the overdose education and naloxone distribution protocol and materials, and for training the team in both. We are grateful to Dr. Michelle Lofwall for executing the stand... | PMC10636969 |
Author contributions | RECRUITMENT | ZK contributed to recruitment, data collection, conceptualization of the research project, iterative revision of the interview guide, development and revision of the codebook, coding, thematic analysis, and development of the paper. HC and AY were both PIs of CARE2HOPE, the larger research project under which this stud... | PMC10636969 | |
Funding | ABUSE | This research has been supported by National Institute on Drug Abuse (NIDA) (4UH3DA044798-03; PIs: Young and Cooper). | PMC10636969 | |
Availability of data and materials | The interview transcripts are not publicly available for confidentiality reasons. | PMC10636969 | ||
Declarations | PMC10636969 | |||
Ethics approval and consent to participate | The study was approved by the University of Kentucky IRB (#52439). Prior to all interviews, oral informed consent was obtained. All recordings, transcripts, and other study materials were stored on secure, password-protected devices. The ClinicalTrials.gov ID for the CARE2HOPE intervention is NCT04134767. The registrat... | PMC10636969 | ||
Consent for publication | Not Applicable. | PMC10636969 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10636969 | ||
References | PMC10636969 | |||
1. Introduction | obesity, −2.7, gestational diabetes, ’, macrosomia, Weight loss, congenital anomalies, weight gain, overweight or obesity, 3rd-trimester, weight loss | OBESITY, GESTATIONAL DIABETES, HYPERTENSIVE DISORDER, COMPLICATIONS, PREECLAMPSIA | Preconception obesity is associated with adverse pregnancy outcomes and deprivation. The postnatal period provides an opportunity for preconception intervention. There is a lack of published postnatal behaviour and weight data to inform intervention needs. Secondary analysis of the GLOWING study explored postnatal diet... | PMC10490453 |
2. Materials and Methods | obesity | OBESITY, SECONDARY | A secondary analysis of data collected as part of the GLOWING pilot trial was undertaken. GLOWING was developed to support midwives’ implementation of UK guidelines for weight management during pregnancy; full details of the intervention are published elsewhere [The northeast of England has a high prevalence of both de... | PMC10490453 |
2.1. Socio-Demographic Data Collection | obesity | OBESITY | The socio-demographic questions include both quantitative and free-text items relating to the women’s 1st trimester BMI, ethnic group, employment, marital, smoking, and breastfeeding status, alcohol intake, and dietary preference. Women’s 1st trimester BMI were collected from electronic health records and used to categ... | PMC10490453 |
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