title
stringlengths 1
1.19k
| keywords
stringlengths 0
668
| concept
stringlengths 0
909
| paragraph
stringlengths 0
61.8k
| PMID
stringlengths 10
11
|
|---|---|---|---|---|
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 primary outcome (a composite of adjudicated acute VTE, arterial thrombosis, treatment with extracorporeal membrane oxygenation, or death) with more bleeding in the intermediate-dose group [ | 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-severe COVID-19. | 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 ability to provide consent to participate and to use data for interventional study, only to use data for observational cohort. Patients were excluded in case of coagulopathy: INR > 1.5, aPTT ratio > 1.4; impaired renal function (clearance to creatinine less than 15 ml/min); known hypersensitivity to heparin; history of heparin induced thrombocytopenia; presence of an active bleeding or condition susceptible of bleeding in presence of anticoagulation (e.g. recent hemorrhagic stroke, peptic ulcer, malignant tumors at high risk of bleeding, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations); body weight < 45 or > 150 kg; concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves); dual antiplatelet therapy; pregnant or breast-feeding women. | 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, respiratory symptoms, and radiographic signs of pneumonia Critical: meet one of three criteria: (1) respiratory failure needing invasive ventilation, (2) septic shock, (3) multiple organ failure. | 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 intermediate dose was chosen to be 1 mg/kg/day which corresponds to half of the recommended enoxaparin therapeutic dose, that is 1 mg/kg twice daily, according to the European Medicines Agency (EMA) technical data sheet of Inhixa [Enoxaparin was to be started on the first day of COVID-19 diagnosis and continued for 14 days, after determination of baseline PT, aPTT, complete blood cell count and creatinine levels. Standard thromboprophylaxis was allowed for a maximum of 72 h before enrollment. | 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 intermediate doses) [The determination of anti-Xa activity was repeated on the fifth or sixth day to monitor any drug accumulation. anti-Xa activity was measured according to locally available test. The effective doses of study drugs received by each participant during the study were recorded.Complete blood cell count was obtained every second day to monitor for heparin induced thrombocytopenia.D-dimer values were determined locally, and values were expressed as ng/ml in FEU (Fibrinogen Equivalent Units) and those measurements expressed as D-Dimer unit were converted into FEU. D-dimer values were expressed as a ratio of the upper limit of reference value (x ULN). In all patients, RT-PCR nasopharyngeal swabs were performed every 7 days to assess virus clearance and determined locally. All other laboratory tests were determined locally. | 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 thrombosis (DVT with compression ultrasound), pulmonary embolism (PE with CT pulmonary angiography), stroke (with CT scan), acute myocardial infarction (according to the 4 | 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 safety analysis after enrolling the first 50 patients. | 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 pulmonary embolism. At 90 days, there were 3 thromboembolic events among patients in the interventional cohort; one patient had both venous thrombosis and pulmonary embolism, two patients had venous thrombosis only. Patients were not routinely evaluated for thromboembolic events in the observational cohort at 90 days. | 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, BMI, diabetes, COPD, hypertension and disease severity at enrollment. Baseline characteristics in the matched groups showed no statistical differences between the two groups after matching (see supplementary Table Mortality at 30 and 90 days did not differ significantly between the two cohorts (Mortality, ICU admission and related events after propensity score matchingLength of hospital days in patients in the interventional and observation cohort after propensity-score matchingThe composite outcome of all-cause mortality at 30-day and 90-day, evolution of the clinical severity during treatment, ICU admission, length of hospital stay was calculated. The composite outcome was 54% (53 /98) in the interventional cohort and 65% (132/203) in the observational cohort ( | 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 was only one major bleeding event in the interventional cohort in a subject on aspirin. Our results suggest that intermediate dose heparin with anti-FXa adjustment could be considered safe. Regarding efficacy assessment, although at the unadjusted analysis the rates of clinical improvement over study visits and the length of hospital stay were more favorable in the interventional group patients, their significance was reduced after the propensity score matching.Differently from the RAPID [Several other randomized clinical trials have been conducted evaluating increased subtherapeutic doses or intermediate dose of LMWH in comparison with standard dose prophylaxis such as the study by Perepu et al. [Several systematic reviews and meta-analyses have also been conducted to assess the efficacy and safety of intermediate/therapeutic in comparison with standard prophylactic doses in hospitalized patients with COVID-19 [Five-thousand four-houndred and five hospitalized patients with COVID-19 were analyzed in a meta-analysis including 8 randomized controlled trials. This meta-analysis showed a statistically significant reduction in the odds of development of thrombotic events in patients underwent to intermediate dose prophilaxis or to therapeutic anti-coagulation relative to ones underwent to prophylactic anticoagulation. However, the main problem was an increased risk of bleeding [A meta-analysis including 33 studies (31 observational, 2 RCT) for a total overall population of 32,688 patients showed that both prophylactic and full dose heparins reduced mortality. However, the full dose was associated with a higher risk of major bleeding compared to prophylactic dose [A Cochrane systematic review included seven RCT (16,185 participants) and showed little to no difference in all-cause mortality or DVT with higher dose UFH, LMWH or rivaroxaban when compared with standard thromboprophylaxis with higher risk of minor bleeding and a slightly higher risk of major bleeding [Finally, a systematic review including a total of 5470 patients from 9 RCTs showed that in hospitalized patients with COVID-19, high-dose thromboprophylaxis with either UFH or LMWH or fondaparinux is more effective than low-dose for the prevention of VTE but increases the risk of major bleeding [The most important results of the INHIXACOVID study appear to be the safety of intermediate dose heparin. anti-Xa adjustment led to a change of dosage in 30 patients and this seems to have increased the safety of intermediate dose heparin. No serious adverse event was correlated to the study drug.Regarding a potential favorable impact on COVID-19 course, although the length of hospitalization was lower in the interventional cohort compared to the observational cohort (median 13 vs. 14 days, The main limitation of this study is the lack of a randomized control group. However, at the time of trial design, a double blind randomized clinical trial was deemed not feasible, to limit the burden on extremely strained healthcare systems because of the pandemic, especially in Italy. Another limitation is the limited sample size with reduced statistical power and the lack of assessment of thromboembolic complications at 90 days of the patients of the observational cohort. Patient’s characteristics may have influenced the decision to enroll patients (selection bias). In addition, clinicians’ decisions to admit patients to ICU or treat them with non-invasive mechanical ventilation could have been influenced by knowledge of the allocated treatment (performance bias). Moreover, random variation could have been caused by the pandemic’s variable impact on hospital resources over time and across regions. Investigation or reporting of potential events (especially incidental deep vein thromboses or bleeding) in patients receiving intermediate heparin could have been less likely than events in patients receiving prophylactic heparin (detection bias). However, an independent clinical events committee blindly adjudicated all relevant outcomes based on clinical reports. Propensity score matching was employed to reduce or eliminate the effects of confounding when using observational data to estimate treatment effects and it was based on those variables which were different at baseline in the two cohorts. | 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 intermediate dose heparin as revealed by other studies in the literature. | 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 is necessary for interpreting the data itself) for initial use and later reuse. All other authors reviewed and edited the paper. The author(s) read and approved the final manuscript. | 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 Agency (AIFA), EudraCT Number: 2020-001308-40. Informed consent was obtained from all enrolled patients.The study was performed in accordance with relevant guidelines/regulations.Informed consent was obtained from all participants and/or their legal guardians. | 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 consulting fees, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events and participated to Data Safety Monitoring Board or Advisory Board from MSD, Gilead Sciences, Jannsen Cilag and Viiv Healthcare and Theratechnologies; A. Stella received consulting fees from Techdow Pharma Italy; A. Romagnoli is employed by Ricerche Nuove Pisa, Italy and received Contract from Techdow Italy Srl for the INHIXACOVID19 Study Management. Other authors declare no known competing financial interest or personal relationship that could have appeared influence the study. | 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 (eg, healthy tissue damage) but significantly worsened movement (eg, dominant hand velocity) and efficiency (eg, rate of tumor removal) metrics. | 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 study is a secondary analysis of a randomized clinical trial and assesses the pedagogical value of technical competencies selected by artificial intelligence (AI) and their extended effects in surgical simulation training. | 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 curriculum were compared with a control group of participants who received no feedback and with expert benchmarks. Cross-sectional data were collected from January to April 2021 from medical students and from March 2015 to May 2016 from experts. This follow-up secondary analysis was conducted from June to September 2022. Participants included medical students (undergraduate year 0-2) in the intervention cohorts and neurosurgeons to establish expertise benchmarks. | 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 change in 32 metrics over the entire procedure and 20 metrics during tumor removal that was not observed in the control group. Participants exposed to the AI-enhanced curriculum demonstrated significant improvement in safety metrics, such as reducing the rate of healthy tissue removal (mean difference, −7.05 × 10 | 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-based learning objectives. | 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 value of AI-selected competencies, we explored their extended associations with other performance criteria and investigated how this changed students’ competency compared with the level of skilled surgeons. To do so, we used a cohort study design by following up medical student’s exposure in the VOA group and comparing their performance outcomes with a control cohort and a skilled cohort. We hypothesized that medical students exposed to the VOA will demonstrate significant changes on several performance criteria related to the AI-selected competencies, and that the observed extended effects are partially responsible for achieving expert performance benchmarks. | 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 benchmarks. | 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 blood, or over the entire scenario. | 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 students [35%] in first year of medical school; and 11 students [24%] in second year of medical school) and had minimal surgical experience. | 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 objectives ( | 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 neurosurgical tumor resection surgery. | 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 bimanual control of the operative field and applying steady force with the bipolar forceps in the nondominant hand. We explored these qualities by looking at instrument divergence and rate of change in the forces applied by the nondominant hand during tumor resection, respectively (Compared with baseline, the change in maximum bipolar force during tumor resection was significantly reduced in the VOA group (mean difference −6.40 × 10VOA participants also demonstrated significant changes in movement metrics of their dominant hand. Notably, by the end of the AI curriculum, students performed with a significantly lower velocity (mean difference, −0.13 [95% CI, −0.17 to −0.09] mm/t, | 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 procedure to appreciate the efficiency of performance. In this metric, although the control group significantly increased their rate (mean difference, 3.10 × 10 | 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 of expertise. Harnessing this power in neurosurgical simulation led our team to design and test the first curriculum with AI-selected competencies. The previous randomized trial involving medical students compared the efficacy of AI tutoring with remote expert instruction using performance outcomes that included only the 4 metrics taught by the VOA.Metrics affected by this AI-enhanced curriculum fall into 1 of 3 categories. The first group includes the intrinsic metrics taught by the intelligent tutoring system. Because the feedback provided by the tutor was focused on these preselected learning objectives, observing the expected outcome provides evidence for feedback efficacy. The second group involves implicit metrics, such as instrument divergence or changes in bipolar force, that despite receiving no direct feedback demonstrated significant change by virtue of their close association with the intrinsic learning objectives. The last group are extrinsic metrics, such as the rate of healthy tissue removal, that have a more complex relationship with the intended learning objectives that cannot be easily implied.Among extrinsic metrics, changes in dominant hand movement were an interesting observation because the students were instructed by the tutor to monitor the acceleration of their nondominant hand and to keep their instruments close together. Nondominant hand training was previously demonstrated to be an effective mode of surgical skill acquisition because of its close association with expertise.It is possible that the modality of feedback presentation contributes to the extended effects observed in this study. As part of the VOA feedback, participants were exposed to four 60-second videos of both competent and novice performance covering each learning objective. Although instructions in each video were specific to 1 metric, participants could potentially gain further information to improve their performance by seeing the expert demonstrations. However, this fails to explain the divergence from benchmarks in some efficiency and movement metrics.The extended effects of this AI curriculum show both productive and counterproductive changes to skill acquisition. Although VOA’s unintentional learning outcomes resulted in students scoring within expert safety benchmarks for this procedure, it diverged some efficiency metrics away from the expert’s benchmarks. In general, VOA participants demonstrated a safer approach with more focused and steady control of the instruments that also resulted in less healthy tissue damage. However, they became significantly slower in movements of their dominant hand and were less efficient in removing the tumor. Such unintended effects must be considered carefully and require a cost-benefit evaluation by experts to determine the acceptability of an intelligent tutoring system. Furthermore, given the extent of unintended outcomes observed in this study, future studies may benefit from measuring the slope of each metric’s learning curve to investigate the learning rate elicited by an AI-enhanced curriculum using extrinsic performance outcomes.One method to evaluate the gains and losses of skill due to unintended effects is to refer to participants’ previously reported expert-rated Objective Structured Assessment of Technical Skills. These results demonstrated that the VOA group achieved a significantly higher overall performance score and a higher economy of movement compared with the control group. | 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 throughout postgraduate training.Students in the VOA group were limited to only post-hoc performance feedback provided by the AI tutor, which lacks important contextual and directional components. For example, unidirectional instructions to reduce force or acceleration at the end of each attempt are likely to result in cumulative rather than time-specific behavioral changes. | 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 the skilled consultant’s benchmarks. Considering these unintended changes, assessment of AI-enhanced curricula requires a cost-benefit evaluation by subject matter experts to determine their acceptance in formal training. Finally, this AI-enhanced curriculum may benefit from contextual and timely feedback either from a live instructor or a real-time performance assessment system. | 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, with a focus on harm reduction and health equity. | 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, we analyze qualitative data with rural PWUD to learn about participants’ experiences with an OEND intervention, and about how participants’ perceptions of their rural risk environments influenced the interventions’ effects. | 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 PWUDs’ confidence in naloxone administration. Through the intervention, over half of participants gained knowledge on naloxone (access points, administration technique) and on the criminal-legal environment as it pertained to naloxone. Most participants opted to accept and carry naloxone, citing factors related to the social environment (responsibility to their community) and physical/healthcare environments (overdose prevalence, suboptimal emergency response systems). Over half of participants described recent experiences administering intervention-provided naloxone. These experiences were shaped by features of the local rural social environment (anticipated negative reaction from recipients, prior naloxone conversations). | 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 paucity of research exploring PWUDs’ first-hand naloxone training and administration experiences in rural settings in the United States, despite the high overdose burden these areas experience. One study based in rural Alaska found that PWUD had positive feelings toward naloxone and perceived it to be highly effective [Most studies focus on the overdose event itself, with limited research exploring the surrounding environmental context, including PWUD’ decisions to carry or not carry naloxone, how PWUD develop plans governing naloxone administration with one another before an overdose occurs, or how they discuss it with other PWUD after overdose events. Understanding how PWUD perceive and experience naloxone within the context of their environment is critical to addressing and reducing barriers to peer naloxone administration, thereby decreasing rates of fatal overdose.One approach to exploring environmental features of drug-related harm is Rhodes’ The current analysis builds on this work by using the | 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 component of the intervention through which participants received nasal naloxone and overdose education. | 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 legal system involvement. Criminal-legal system involvement was defined as arrest; incarceration; community supervision (probation or parole); or involvement with the courts, including the Child Protective Services system. The population of criminal-legal involved people who use opioids/people who inject drugs was selected in collaboration with community coalitions in each of the study counties. These community coalitions highlighted the elevated risk of overdose and pressing healthcare and social service needs among the study population.Individuals were recruited into C2H via multiple community-based pathways, including via tabling outside probation and parole offices, courthouses, and harm reduction programs; cookouts near places where eligible individuals might live or seek services; flyers; and word of mouth.To be eligible for this qualitative sub-study, individuals had to have been enrolled in the larger C2H intervention for at least three months prior to the interview and to have taken part in an initial screening and a baseline survey. We (ZK, LP) purposively sampled C2H participants, seeking to create a qualitative sample of people that varied by county and gender. We invited individuals to take part in a qualitative interview through the means of communication they permitted staff to use (phone calls, texts, emails, and/or Facebook messages). Some recruitment was facilitated through C2H REHNs who helped qualitative study staff contact hard-to-reach participants. See Table Description of Sample | 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/or Zoom-equipped technology utilized C2H office space; REHNs were not in the offices while interviews were conducted.The interview guide (see Table Naloxone/Narcan Questions from Interview GuideSub-set of codebook pertaining to naloxone/narcan | 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 stigma, and (d) enhancing positive feelings toward naloxone. | 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 going on, anything can happen in the spur of a moment. And I know as long as I've got [Narcan] on me, if something like that ever happens around me, it could save somebody's life.– Female, County 7The local rural | 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 knew we had it and they didn't.”– Male, County 7One participant shared that her social role as a naloxone carrier was important because “One participant expressed that she had not experienced social obligation in the past:I was a very careless addict. I didn't really care. I was the type of addict on heroin that my friend would overdose in front of me and I would pick their pockets for their dope and not even call an ambulance. So I didn't really care. I didn't feel the need to have it.– Female, County 7Later in the interview, this participant went on to say that several recent life changes (e.g., moving, drug cessation, family loss) had led changes in her perceptions and behavior, and that she now does carry intervention-distributed naloxone with her.The helper role was a critical driver for some participants’ (n = 7) decision to carry naloxone. Participants said that they carried naloxone in part because they had access to it and their fellow community members often did not, amplifying their sense of social responsibility. | 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 stigma as something that had made them hesitant to carry naloxone:There's times I have been stopped, afraid the law would try to charge me with something... But [that was] before I got into the CARE2HOPE. Once I got into this program, it lightened my feelings up on if I got stopped, because [Narcan] actually helps people…I realized not to worry if I've got it, because it's actually to help people.– Male, County 7In this participant’s case, the intervention mitigated the impact of police stigma. Through engaging with naloxone training, he both enhanced his positive feelings toward naloxone and reduced his fear of consequences to carrying it. Another participant explained that the desire to be prepared to respond to overdose outweighed the fear of arrest: Community-level stigma, defined as experienced and anticipated judgment from community members, was less salient to participants’ decisions to carry naloxone. Some reported that carrying naloxone was normalized in his community, stating, In addition to stigma, participants who opted not to carry naloxone (n = 10) offered various reasons for their decision. Two participants explained that their preference not to carry naloxone was rooted in a desire to distance themselves from social network members who use drugs: “I keep [my naloxone] at home… I don’t mess with nobody that does drugs. I stay away from them.” Others (n = 5) simply expressed a preference for keeping naloxone in their drawer or medicine cabinet. One participant explained that she was currently residing in a crisis stabilization center and was unable to carry naloxone:Where I’m at in this crisis home right now, there’s not really a need [to carry naloxone]. They also have to lock it up. I’m not really allowed to have anything… I can get [the naloxone] if I need it, but I can’t carry it.– Female, County 7While some participants’ experiences | 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 individual during an overdose event. A sub-group of participants (n = 6) described administering naloxone in the past but did not have recent experience with administering C2H-provided naloxone. Another sub-group (n = 6) recalled no experiences administering naloxone, before, during, or after the intervention.Participants with recent naloxone administration experience (n = 16) described a range of barriers and facilitators to administering naloxone, largely rooted in the | 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 on drugs they can no longer feel the effects of.Several participants had experienced overdose reversal themselves and empathized with their peers’ response. Apprehension about administering naloxone was often rooted in first-hand knowledge of overdose reversal discomfort. Participants described rapid-onset withdrawal symptoms associated with overdose reversal. One participant explained that she had been angry with people in the past for using naloxone on her because, Often, recipients’ negative reactions to overdose reversal stemmed from the loss of high in addition to the physiological withdrawal symptoms described above. Nine participants spoke to recipients’ Some participants (n = 3) explained that the recipients’ reactions upon revival were driven in part by feelings of having lost or “wasted” money, a feature of the Some of them are just like, "That's the only money I got. If you Narcan me and I go back to being completely sober, I'm going to be mad because, pretty much, I bought those drugs for nothing. I'm not going to feel them, and I'm not going to be able to get anymore," which, even as an addict, it's crazy to me. I just couldn't imagine being in that min7dset and thinking that that high is more important than me waking up.– Female, County 4Participants often administered naloxone Two participants said that anticipation of the recipient’s reaction made them delay naloxone administration or exhaust alternative options prior to trying naloxone. One participant explicitly stated that naloxone was a last resort: Participants overcame barriers to administering naloxone by weighing the consequences of naloxone administration (e.g., adverse recipient reaction) against the consequences of doing nothing (fatal overdose). The C2H intervention helped participants overcome barriers by providing access to naloxone (reducing scarcity, actual and perceived), increasing confidence in naloxone administration through training, and reducing fear of | 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 intention to administer naloxone despite the other party’s objections. | 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 to naloxone, increasing participants’ knowledge of naloxone efficacy and administration technique, and increasing some participants’ confidence in naloxone administration. Over half of participants gained knowledge on naloxone through the intervention related to the healthcare environment (how to access naloxone, administration technique) and political/law enforcement environment (medical amnesty policies). Through knowledge and skills gained in the intervention, participants became a part of their local healthcare environment: most participants opted to carry naloxone, citing factors related to the social environment (responsibility to community) and physical/healthcare environments (high overdose prevalence, suboptimal emergency response systems). Over half of participants had recent experience administering intervention-provided naloxone. Experiences administering naloxone to peers was largely shaped by social environment considerations (anticipated negative reaction from recipients attributable to physiological withdrawal, loss of high, and economic loss). Participants who felt strong social ties to their community often administered naloxone despite anticipated consequences.While there is a growing body of research on naloxone experiences [ | 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 criminal-legal system/political considerations were especially relevant because our participants were criminal-legal involved and distrusted law enforcement. Learning about their legal rights helped participants feel more confident carrying and administering naloxone. However, the intervention did not impact policy or conduct outreach and education to law enforcement or other criminal-legal system representatives. Therefore, the intervention’s impact was limited to participants’ knowledge and confidence surrounding naloxone. | 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 response systems in a geographically dispersed area with few roads per acre. One participant reasoned, | 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 context to the existing body of literature. The application of the R-REF as the guiding framework for our study is a key strength of this study, missing from other studies that explore naloxone experiences in rural environments. This framework helps us to contextualize findings in relation to a long-standing body of scholarly work [Among the limitations of this study is missing perspectives. Our sample was skewed toward participants with sustained engagement in the intervention. We lack perspectives of people who were re-incarcerated or otherwise disengaged from the program during our recruitment period. Furthermore, our sample was largely comprised of white participants, meaning that we lack important perspectives of rural people of color. Our sample was also solely comprised of participants with criminal-legal system involvement. Individuals who had not been recently involved in this system might have expressed less concern about police response to finding naloxone during a search.During data collection, some interviews were impacted by poor cellular/internet connection. While the researchers took steps to mitigate disruption (e.g., arranging office space/computers for participants to use, supplementing transcripts with detailed notes), transcripts still reflect some inaudible moments.Another limitation is that naloxone experiences were not the sole focus of the interview guide. Furthermore, the naloxone questions were placed toward the end of the guide. While this structure allowed the interviewer to build trust and rapport with participants before discussing naloxone experiences, it also increased risk of participant fatigue.Regarding positionality, the primary interviewer is not from a rural Appalachian community. While the interviewer strived to build rapport and avoid stigmatizing language, she may have been perceived as an outsider by participants. However, having third party distinct from the C2H REHNS conducting interviews was a methodological strength as it enabled participants to openly share their experiences. | 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 intervention altered participants’ healthcare environment by providing education on naloxone’s existence, effectiveness, and administration technique. Participants’ trust in REHNs (driven by REHNs’ knowledge of the community and non-stigmatizing approach) allowed participants to be receptive to new information about naloxone. Participants’ physical environments, characterized by slow emergency response systems, high prevalence of overdose, and presence of fentanyl drive decisions to carry naloxone despite anticipated and realized consequences (e.g., police harassment). Participants’ decisions to administer naloxone are sometimes complicated by social environment considerations. When PWUD administer naloxone to a network member, they are often acting against the recipient’s communicated desires and are sometimes met with anger. Although many rural PWUD administer naloxone despite social consequences, participants report that the event can be emotionally difficult, necessitating multipronged means of support.Findings highlight need for more community-centered OEND interventions; greater outreach to rural PWUD on local policy that impacts them; tailored strategies to help PWUD engage in productive dialogue with peers about naloxone and navigate interpersonal conflict associated with overdose reversal; and opportunities for rural PWUD to formally participate in emergency response systems as peer overdose responders. | 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 standing order that allowed us to obtain the naloxone from KORE. We would like to thank Lauren Pieczykolan, MPH, who contributed to recruitment and data collection; Edward Freeman, MPhil, who ensured each participant was compensated for their time; the CARE2HOPE Rural Health Navigators for supporting with recruitment and working diligently to enhance the health and wellbeing of their community; and all the participants who shared their experiences with us. | 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 study falls. HC also contributed to conceptualization of the research project, development of interview guide, interpretation of results, and development of the paper. AY also reviewed early results as well as the final paper and provided feedback. UI contributed to development and revision of the interview guide, development and revision of the codebook, interpretation of results, and provided feedback on the paper’s contents. ML reviewed early results and provided feedback and contributed to the development of Table 1, description of the sample. KL contributed to recruitment, reviewed the paper, and provided feedback. KK reviewed the paper and provided feedback. | 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 registration date was October 19th, 2019. | 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, physical activity (PA) and weight among women living with obesity in deprivation. Thirty-nine women completed food frequency and PA questionnaires and provided weight measurement(s) between 3–12 months postnatal. Women’s diet and PA fell short of national guidelines, especially for fruit/vegetables (median 1.6–2.0 portions/day) and oily fish (0–4 g/day). PA was predominantly light intensity. Patterns in weight change across time points indicated postnatal weight loss compared with 1st (median −0.8 to −2.3 kg) and 3rd-trimester weights (−9.0 to −11.6 kg). Weight loss was higher among women without excessive gestational weight gain (GWG) (−2.7 to −9.7 kg) than those with excessive GWG (2.3 to −1.8 kg), resulting in postnatal weight measurements lower than their 1st trimester. These pilot data suggest preconception interventions should commence in pregnancy with a focus on GWG, and postnatal women need early support to achieve guideline-recommendations for diet and PA. Further research in a larger population could inform preconception intervention strategies to tackle inequalities in maternal obesity and subsequent pregnancy outcomes.The association between pre-pregnancy obesity and adverse maternal and infant health outcomes in pregnancy and throughout the life course is well-established, highlighting the need for preconception weight management support. Complications include hypertensive disorders (e.g., preeclampsia), gestational diabetes, caesarean deliveries, stillbirth, maternal mortality, congenital anomalies, and macrosomia [Supporting women with weight management in the postnatal period is an opportunity for preconception intervention for subsequent pregnancies—the inter-pregnancy period. A recent systematic review showed that, for women with overweight or obesity, interpregnancy weight loss decreased the risk of caesarean delivery, gestational diabetes and hypertensive disorders in subsequent pregnancies [Despite the existence of guidelines, there are no published data reporting patterns of postnatal PA, diet, and weight change in women with obesity in the UK or globally. A 2015 systematic review, not restricted to women with obesity [Gaining a better understanding of women’s dietary and PA behaviours’ and weight change during the postnatal period would highlight areas where women might benefit from additional intervention and support to improve their overall health and contribute to healthy weight management. This study aimed to explore the patterns of diet PA behaviours, and weight change among postnatal women living with obesity in a highly deprived region of the UK. | 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 deprivation and maternal obesity [ | 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 categorise their obesity class using the WHO criteria: class 1 BMI 30.0–34.9 kg/m | PMC10490453 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.