34 results on '"T. Lavin"'
Search Results
2. REAL TIME QUALITY ASSURANCE OF DEPRESSION RATINGS IN PSYCHIATRIC CLINICAL TRIALS
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MS, Marc Korczykowski,, primary, FRAPS, Philip T. Lavin, PhD, FASA,, additional, Kolesar, Courtney, additional, PhD, Ian R. Sharp,, additional, PhD, Michael T. Sapko, MD,, additional, and MPH, Jonathan C. Javitt, MD,, additional
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- 2023
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3. Data from Three-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study
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Barry M. Berger, Anas Daghestani, Seth Sweetser, Paul J. Limburg, Folasade P. May, Steven H. Itzkowitz, Debbie Jakubowski, Tara N. Marti, Philip T. Lavin, and Thomas F. Imperiale
- Abstract
Data supporting the clinical utility of multi-target stool DNA (mt-sDNA) at the guideline-recommended 3-year interval have not been reported.Between April 2015 and July 2016, candidates for colorectal cancer screening whose providers prescribed the mt-sDNA test were enrolled. Participants with a positive baseline test were recommended for colonoscopy and completed the study. Those with a negative baseline test were followed annually for 3 years. In year 3, the mt-sDNA test was repeated and colonoscopy was recommended independent of results. Data were analyzed using the Predictive Summary Index (PSI), a measure of the gain in certainty for dichotomous diagnostic tests (where a positive value indicates a net gain), and by comparing observed versus expected colorectal cancers and advanced precancerous lesions.Of 2,404 enrolled subjects, 2,044 (85%) had a valid baseline mt-sDNA result [284 (13.9%) positive and 1,760 (86.1%) negative]. Following participant attrition, the year 3 intention to screen cohort included 591 of 1,760 (33.6%) subjects with valid mt-sDNA and colonoscopy results, with no colorectal cancers and 63 advanced precancerous lesions [22 (34.9%) detected by mt-sDNA] and respective PSI values of 0% (P = 1) and 9.3% (P = 0.01). The observed 3-year colorectal cancer yield was lower than expected (one-sided P = 0.09), while that for advanced precancerous lesions was higher than expected (two-sided P = 0.009).Repeat mt-sDNA screening at a 3-year interval resulted in a statistically significant gain in detection of advanced precancerous lesions. Due to absence of year 3 colorectal cancers, the PSI estimate for colorectal cancer was underpowered and could not be reliably quantified. Larger studies are required to assess the colorectal cancer study findings.Prevention Relevance:Understanding the 3-year yield of mt-sDNA for colorectal cancer and advanced precancerous polyps is required to ensure the clinical appropriateness of the 3-year interval and to optimize mt-sDNA's screening effectiveness.
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- 2023
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4. Supplementary Tables S1-S2 from Three-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study
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Barry M. Berger, Anas Daghestani, Seth Sweetser, Paul J. Limburg, Folasade P. May, Steven H. Itzkowitz, Debbie Jakubowski, Tara N. Marti, Philip T. Lavin, and Thomas F. Imperiale
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Supplemental Table S1: Distribution of colorectal lesions among subjects at baseline (T0) and year 3 (T3). Supplemental Table S2: Study subject accountability in the baseline negative population
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- 2023
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5. Supplementary Text from Three-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study
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Barry M. Berger, Anas Daghestani, Seth Sweetser, Paul J. Limburg, Folasade P. May, Steven H. Itzkowitz, Debbie Jakubowski, Tara N. Marti, Philip T. Lavin, and Thomas F. Imperiale
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This Supplemental Text file provides additional information regarding the clinical procedures and sample processing/lab procedures, as well as an explanation of the sensitivity and robustness analyses.
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- 2023
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6. Three-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study
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Thomas F. Imperiale, Philip T. Lavin, Tara N. Marti, Debbie Jakubowski, Steven H. Itzkowitz, Folasade P. May, Paul J. Limburg, Seth Sweetser, Anas Daghestani, and Barry M. Berger
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Aging ,screening and diagnosis ,Cancer Research ,Prevention ,Clinical Sciences ,Oncology and Carcinogenesis ,DNA ,Colonoscopy ,Colo-Rectal Cancer ,Feces ,Detection ,Oncology ,Clinical Research ,Genetics ,Humans ,Mass Screening ,Longitudinal Studies ,Oncology & Carcinogenesis ,Colorectal Neoplasms ,Digestive Diseases ,Precancerous Conditions ,Early Detection of Cancer ,Cancer ,4.2 Evaluation of markers and technologies - Abstract
Data supporting the clinical utility of multi-target stool DNA (mt-sDNA) at the guideline-recommended 3-year interval have not been reported. Between April 2015 and July 2016, candidates for colorectal cancer screening whose providers prescribed the mt-sDNA test were enrolled. Participants with a positive baseline test were recommended for colonoscopy and completed the study. Those with a negative baseline test were followed annually for 3 years. In year 3, the mt-sDNA test was repeated and colonoscopy was recommended independent of results. Data were analyzed using the Predictive Summary Index (PSI), a measure of the gain in certainty for dichotomous diagnostic tests (where a positive value indicates a net gain), and by comparing observed versus expected colorectal cancers and advanced precancerous lesions. Of 2,404 enrolled subjects, 2,044 (85%) had a valid baseline mt-sDNA result [284 (13.9%) positive and 1,760 (86.1%) negative]. Following participant attrition, the year 3 intention to screen cohort included 591 of 1,760 (33.6%) subjects with valid mt-sDNA and colonoscopy results, with no colorectal cancers and 63 advanced precancerous lesions [22 (34.9%) detected by mt-sDNA] and respective PSI values of 0% (P = 1) and 9.3% (P = 0.01). The observed 3-year colorectal cancer yield was lower than expected (one-sided P = 0.09), while that for advanced precancerous lesions was higher than expected (two-sided P = 0.009). Repeat mt-sDNA screening at a 3-year interval resulted in a statistically significant gain in detection of advanced precancerous lesions. Due to absence of year 3 colorectal cancers, the PSI estimate for colorectal cancer was underpowered and could not be reliably quantified. Larger studies are required to assess the colorectal cancer study findings. Prevention Relevance: Understanding the 3-year yield of mt-sDNA for colorectal cancer and advanced precancerous polyps is required to ensure the clinical appropriateness of the 3-year interval and to optimize mt-sDNA's screening effectiveness.
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- 2022
7. National, Regional, and Global Estimates of Preterm Birth in 2020, With Trends From 2010: A Systematic Analysis.
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E. O., Ohuma, A.-B., Moller, E., Bradley, S., Chakwera, L., Hussain-Alkhateeb, A., Lewin, Y. B., Okwaraji, W. R., Mahanani, E. W., Johansson, T., Lavin, D. E., Fernandez, G. G., Domínguez, A., de Costa, J. A., Cresswell, J., Krasevec, J. E., Lawn, H., Blencowe, J., Requejo, and A. C., Moran
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- 2024
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8. Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients With Celiac Disease Exposed to a Gluten Challenge
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Joseph A. Murray, Jack A. Syage, Tsung-Teh Wu, Matthew A. Dickason, Ana G. Ramos, Carol Van Dyke, Irina Horwath, Philip T. Lavin, Markku Mäki, Isabel Hujoel, Konstantinos A. Papadakis, Adam C. Bledsoe, Chaitan Khosla, Jennifer A. Sealey-Voyksner, Chad Hinson, Vasiliy Loskutov, Anna Norum, Steven Linberg, Lawrence Goldkind, Jorma Isola, Robert Voyksner, Pauline Luong, Matthew Baldwin, and Jennifer Nezzer
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Celiac Disease ,Glutens ,Hepatology ,Gastroenterology ,Humans ,Intestinal Mucosa ,Peptide Hydrolases - Abstract
Gluten ingestion in patients with celiac disease can lead to gastrointestinal symptoms and small intestinal mucosal injury.This gluten challenge phase 2 trial was double blind and placebo controlled, and it assessed the efficacy and safety of a 1200-mg dose of IMGX003 in patients with celiac disease exposed to 2 g of gluten per day for 6 weeks. The change in the ratio of villus height to crypt depth was the primary endpoint. Secondary endpoints included density of intraepithelial lymphocytes and symptom severity. These endpoints were evaluated by analysis of covariance. Additional endpoints included serology and gluten-immunogenic peptides in urine.Fifty patients were randomized, and 43 patients completed the study (IMGX003, n = 21; placebo, n = 22). The mean change in the ratio of villus height to crypt depth (primary endpoint) for IMGX003 vs placebo was -0.04 vs -0.35 (P = .057). The mean change in the density of intraepithelial lymphocytes (secondary endpoint) for IMGX003 vs placebo was 9.8 vs 24.8 cells/mm epithelium (P = .018). The mean change (worsening) in symptom severity in relative units (secondary endpoint) for IMGX003 vs placebo was 0.22 vs 1.63 (abdominal pain, P = .231), 0.96 vs 3.29 (bloating, P = .204), and 0.02 vs 3.20 (tiredness, P = .113). The 3 × 2-week trend line significance values for these symptoms, respectively, were P = .014, .030, and .002.IMGX003 reduced gluten-induced intestinal mucosal damage and symptom severity. (ClinicalTrials.gov, Number: NCT03585478).
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- 2022
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9. Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma head and neck (SCCHN): Using pretreatment data only
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Eyal Talor, Philip T Lavin, and Dusan Markovic
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Cancer Research ,Oncology - Abstract
e18070 Background: Locally advanced primary SCCHN, DDT options (radiotherapy (RTx) or concurrent Chemoradiotherapy (CRTx)) is performed only following surgery (National Comprehensive Cancer Network [NCCN] Guidelines). A novel 2-step exclusion algorithm was developed, based only on N classification and imaging (CT; MRI +/- PET) to detect clinical features only from screening/entry findings. The algorithm was developed using the IT-MATTERS SCCHN pivotal study (Clinical trials.gov NCT01265849) data to identify treatment naïve lower risk (LR) for recurrence subjects receiving neoadjuvant immunotherapy prior to surgery to optimize long-term overall survival (OS). Methods: SCCHN patients are routinely examined and imaged at entry/screening to establish TNM classification and disease stage. Imaging is performed using CT, MRI, and/or PET-CT/PET-MRI per NCCN Guidelines. These imaging techniques can reliably detect extracapsular cervical lymph node spread before surgery, allowing the algorithm to be constructed and validated. Algorithm rules target CRTx bound (“High-Risk”) patients leaving RTx bound (“Low-Risk”) locally advanced primary disease patients at entry. The 2-step exclusions are: (1) exclude all N2 leaving only those with N0-N1, (2) further exclude those exhibiting extra capsular spread (PET-CT or PET-MRI). We retained those determined by study physicians to receive CRTx for the algorithm validation exercise only. The n = 923 pivotal study intent to treat (ITT) population was used to validate the algorithm. Results: Overall algorithm coverage was 99.9% (922/923 ITT except one missing N case) with 24.6% having N2 and 75.3% N0/N1. Among algorithm exclusions, 81.3% (282/347) were High-Risk; among algorithm inclusions, 60.6% (349/576) were Low-Risk. Algorithm validation: Among all Low-Risk cases in the study (n = 380), 91.8% (349/380) met the algorithm criteria; among all High-Risk cases, 60.4% (282/467) were correctly excluded by the algorithm. Remaining were physician choice. Overall, algorithm alone predicted 74.5% (631/847) risk group (combined low and high) accurately. Significant OS advantage (2-sided log rank p = 0.0376) to Immunotherapy regimen + standard of care (SOC) surgery + RTx vs SOC alone was seen for Low-Risk cases selected only by the 2-step algorithm. Conclusions: The algorithm provided near perfect (99.9%) ITT population coverage, achieved near 75% overall accuracy, with 91.8% accurate predictive value for the low-risk group demonstrating significant OS. Thus, risk group can be inferred at screening consistent with clinical practice and NCCN Guidelines. The algorithm can be used to help identify low risk SCCHN patients at entry to receive neoadjuvant immunotherapy before surgery.
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- 2022
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10. NF2 -related schwannomatosis and other schwannomatosis: an updated genetic and epidemiological study.
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Forde C, Smith MJ, Burghel GJ, Bowers N, Roberts N, Lavin T, Halliday J, King AT, Rutherford S, Pathmanaban ON, Lloyd S, Freeman S, Halliday D, Parry A, Axon P, Buttimore J, Afridi S, Obholzer R, Laitt R, Thomas O, Stivaros SM, Vassallo G, and Evans DG
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- Humans, Male, Female, Transcription Factors genetics, Prevalence, Adult, Mutation genetics, Middle Aged, Genetic Predisposition to Disease, Adolescent, Neurilemmoma genetics, Neurilemmoma epidemiology, Neurilemmoma pathology, Neurofibromatoses genetics, Neurofibromatoses epidemiology, Neurofibromatoses pathology, Neurofibromatosis 2 genetics, Neurofibromatosis 2 epidemiology, Skin Neoplasms genetics, Skin Neoplasms epidemiology, Skin Neoplasms pathology, SMARCB1 Protein genetics, Neurofibromin 2 genetics
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Objectives: New diagnostic criteria for NF2-related schwannomatosis (NF2) were published in 2022. An updated UK prevalence was generated in accordance with these, with an emphasis on the rate of de novo NF2 (a 50% frequency is widely quoted in genetic counselling). The distribution of variant types among de novo and familial NF2 cases was also assessed., Methods: The UK National NF2 database identifies patients meeting updated NF2 criteria from a highly ascertained population cared for by England's specialised service. Diagnostic prevalence was assessed on 1 February 2023. Molecular analysis of blood and, where possible, tumour specimens for NF2, LZTR1 and SMARCB1 was performed., Results: 1084 living NF2 patients were identified on prevalence day (equivalent to 1 in 61 332). The proportion with NF2 inherited from an affected parent was only 23% in England. If people without a confirmed molecular diagnosis or bilateral vestibular schwannoma are excluded, the frequency of de novo NF2 remains high (72%). Of the identified de novo cases, almost half were mosaic. The most common variant type was nonsense variants, accounting for 173/697 (24.8%) of people with an established variant, but only 18/235 (7.7%) with an inherited NF2 pathogenic variant (p<0.0001). Missense variants had the highest proportion of familial association (56%). The prevalence of LZTR1 -related schwannomatosis and SMARCB1 -related schwannomatosis was 1 in 527 000 and 1 in 1.1M, respectively, 8.4-18.4 times lower than NF2., Conclusions: This work confirms a much higher rate of de novo NF2 than previously reported and highlights the benefits of maintaining patient databases for accurate counselling., Competing Interests: Competing interests: DGE has received consultancy fees from AstraZeneca, Springworks and Everything Genetic Ltd., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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11. Prevalence, perinatal outcomes and factors associated with neonatal sepsis in Nigeria.
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Onubogu CU, Ekwochi U, Obumneme-Anyim I, Nwokeji-Onwe LN, Eleje GU, Ojiegbe NO, Ezebialu IU, Ezenkwele EP, Nzeribe EA, Umeh UA, Ugwu IA, Chianakwana O, Ibekwe NT, Ezeaku OI, Ekweagu GN, Onwe AB, Lavin T, Ezekwe B, Settecase E, Tukur J, and Ikechebelu JI
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- Humans, Female, Nigeria epidemiology, Infant, Newborn, Pregnancy, Prevalence, Adult, Risk Factors, Pregnancy Outcome epidemiology, Prenatal Care statistics & numerical data, Young Adult, Male, Logistic Models, Neonatal Sepsis epidemiology
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Objective: To examine the prevalence, perinatal outcomes and factors associated with neonatal sepsis in referral-level facilities across Nigeria., Design: Secondary analysis of data from the Maternal and Perinatal Database for Quality, Equity and Dignity Programme in 54 referral-level hospitals across Nigeria., Setting: Records covering the period from 1 September 2019 to 31 August 2020., Population: Mothers admitted for birth during the study period, and their live newborns., Methods: Analysis of prevalence and sociodemographic and clinical factors associated with neonatal sepsis and perinatal outcomes. Multilevel logistic regression modelling identified factors associated with neonatal sepsis., Main Outcome Measures: Neonatal sepsis and perinatal outcomes., Results: The prevalence of neonatal sepsis was 16.3 (95% CI 15.3-17.2) per 1000 live births (1113/68 459) with a 10.3% (115/1113) case fatality rate. Limited education, unemployment or employment in sales/trading/manual jobs, nulliparity/grand multiparity, chronic medical disorder, lack of antenatal care (ANC) or ANC outside the birthing hospital and referral for birth increased the odds of neonatal sepsis. Birthweight of <2500 g, non-spontaneous vaginal birth, preterm birth, prolonged rupture of membranes, APGAR score of <7 at 5 min, birth asphyxia, birth trauma or jaundice were associated with neonatal sepsis. Neonates with sepsis were more frequently admitted to a neonatal intensive care unit (1037/1110, 93.4% vs 8237/67 346, 12.2%) and experienced a higher rate of death (115/1113, 10.3% vs 933/67 343, 1.4%)., Conclusions: Neonatal sepsis remains a critical challenge in neonatal care, underscored by its high prevalence and mortality rate. The identification of maternal and neonatal risk factors underscores the importance of improved access to education and employment for women and targeted interventions in antenatal and intrapartum care., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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12. Neonatal jaundice incidence, risk factors and outcomes in referral-level facilities in Nigeria.
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Ochigbo S, Ekpebe P, Nyong EE, Ikechukwu O, Ibeawuchi A, Eigbedion A, Adeyemi OO, Abasiattai A, Orazulike N, Ekott M, Omo-Aghoja L, Ande B, Uwagboe C, Igbarumah S, Idemudia E, Okagua J, Lavin T, Gibbons L, Settecase E, Njoku A, Ibrahim IA, and Etuk S
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- Humans, Nigeria epidemiology, Infant, Newborn, Risk Factors, Female, Cross-Sectional Studies, Incidence, Pregnancy, Male, Adult, Jaundice, Neonatal epidemiology, Referral and Consultation statistics & numerical data
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Objective: To determine the incidence, risk factors and outcomes of babies with neonatal jaundice in a network of referral-level hospitals in Nigeria., Design: A cross-sectional analysis of perinatal data collected over a 1-year period., Setting: Fifty-four referral-level hospitals (48 public and 6 private) across the six geopolitical zones of Nigeria., Population: A total of 77 026 babies born at or admitted to the participating facilities (67 697 hospital live births; plus 9329 out-born babies), with information on jaundice between 1 September 2019 and 31 August 2020., Methods: Data were extracted and analysed to calculate incidence and sociodemographic and clinical risk factors for neonatal jaundice., Main Outcome Measures: Incidence and risk factors of neonatal jaundice in the 54-referral hospitals in Nigeria., Results: Of 77 026 babies born in or admitted to the participating facilities, 3228 had jaundice (41.92 per 1000 live births). Of the 67 697 hospital live births, 845 babies had jaundice (12.48 per 1000 live births). The risk factors associated with neonatal jaundice were no formal education (adjusted odds ratio [aOR] 1.68, 95% CI 1.11-2.52) or post-secondary education (aOR 1.17, 95% CI 0.99-1.38), previous caesarean section (aOR 1.68, 95% CI 1.40-2.03), booked antenatal care at <13 weeks or 13-26 weeks of gestation (aOR 1.58, 95% CI 1.20-2.08; aOR 1.15, 95% CI 0.93-1.42, respectively), preterm birth (aOR 1.43, 95% CI 1.14-1.78) and labour more than 18 hours (aOR 2.14, 95% CI 1.74-2.63)., Conclusions: Hospital-level and regional-level strategies are needed to address newborn jaundice, which include a focus on management and discharge counselling on signs of jaundice., (© 2024 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)
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- 2024
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13. Outcomes and quality of care for women and their babies after caesarean section in Nigeria.
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Adeniran AS, Nwachukwu DC, Ocheke AN, Mohammed SO, Musa AO, Ochejele S, Ibraheem RS, Pam S, Mairami AB, Gobir AA, Olateju EK, Baba FJ, Medupin PF, Ahmed G, Ango S, Akaba G, Ogunkunle TO, Agada E, Gibbons L, Oladapo OT, Lavin T, Tukur J, and Aboyeji AP
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- Humans, Female, Nigeria epidemiology, Pregnancy, Adult, Cross-Sectional Studies, Infant, Newborn, Young Adult, Cesarean Section statistics & numerical data, Maternal Mortality, Quality of Health Care statistics & numerical data, Perinatal Mortality
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Objective: To describe the outcomes and quality of care for women and their babies after caesarean section (CS) in Nigerian referral-level hospitals., Design: Secondary analysis of a nationwide cross-sectional study., Setting: Fifty-four referral-level hospitals., Population: All women giving birth in the participating facilities between 1 September 2019 and 31 August 2020., Methods: Data for the women were extracted, including sociodemographic data, clinical information, mode of birth, and maternal and perinatal outcomes. A conceptual hierarchical framework was employed to explore the sociodemographic and clinical factors associated with maternal and perinatal death in women who had an emergency CS., Main Outcome Measures: Overall CS rate, outcomes for women who had CS, and factors associated with maternal and perinatal mortality., Results: The overall CS rate was 33.3% (22 838/68 640). The majority of CS deliveries were emergency cases (62.8%) and 8.1% of CS deliveries had complications after delivery, which were more common after an emergency CS. There were 179 (0.8%) maternal deaths in women who had a CS and 29.6% resulted from complications of hypertensive disorders of pregnancy. The overall maternal mortality rate in women who delivered by CS was 778 per 100 000 live births, whereas the perinatal mortality at birth was 51 per 1000 live births. Factors associated with maternal mortality in women who had an emergency CS were being <20 or >35 years of age, having a lower level of education and being referred from another facility or informal setting., Conclusions: One-third of births were delivered via CS (mostly emergency), with almost one in ten women experiencing a complication after a CS. To improve outcomes, hospitals should invest in care and remove obstacles to accessible quality CS services., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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14. Predictors, prevalence and outcome of hypertensive disorders in pregnancy in Nigerian tertiary health facilities.
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Abdurrahman A, Adamu AN, Ashimi A, Adekunle OO, Bature SB, Aliyu LD, Akeem O, Abdullahi H, Lavin T, Daneji S, Musa B, Muazu Z, Tukur J, and Galadanci HS
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- Humans, Female, Pregnancy, Adult, Nigeria epidemiology, Prevalence, Cross-Sectional Studies, Risk Factors, Tertiary Care Centers statistics & numerical data, Young Adult, Eclampsia epidemiology, Hypertension, Pregnancy-Induced epidemiology, Pregnancy Outcome epidemiology
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Objective: Determine prevalence, risk factors and outcomes of hypertensive disorders in pregnancy (HDP)., Design: Cross-sectional analysis of data captured in the Maternal and Perinatal Database for Quality, Equity and Dignity (MPD-4-QED) between September 2019 and August 2020., Setting: Fifty-four referral level facilities in Nigeria., Population: Women whose pregnancy ended (irrespective of the location or duration of pregnancy) or who were admitted within 42 days of delivery., Methods: Descriptive statistics and multilevel mixed-effects logistic regression models., Main Outcome Measures: Prevalence of HDP, sociodemographic and clinical factors associated with HDP and perinatal outcomes., Results: Among the 71 758 women 6.4% had HDP and gestational hypertension accounted for 49.8%. Preeclampsia and eclampsia were observed in 9.5% and 7.0% of all pregnancies, respectively. The predictors of HDP were age over 35 years (OR1.96, 95% CI 1.82-2.12; p < 0.001), lack of formal educational (OR 1.18, 95% CI 1.06-1.32; p = 0.002), primary level of education (OR 1.20, 95% CI 1.03-1.4; p < 0.002), nulliparity (OR 1.21, 95% CI 1.12-1.31; p < 0.001), grand-multiparity (OR 1.36, 95%CI 1.21-1.52; p < 0.001), previous caesarean section (OR 1.26, 95%CI 1.15-1.38; p < 0.001) and previous miscarriage (OR 1.22, 95% CI 1.13-1.31; p < 0.001). Overall 3.7% of the patients with HDP died, with eclampsia having the highest case fatality rate of 27.9%. Stillbirth occurred in 11.9% of pregnancies with hypertensive disorders., Conclusions: Hypertensive disorders in pregnancy are not uncommon in Nigeria. They are associated with adverse outcomes with over one-quarter of women with eclampsia dying. The main predictors include older age, poor education, extremes of parity and previous CS or miscarriage. Maternal and perinatal outcomes are poor with about a quarter developing complications and about 1 in 10 having stillbirths., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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15. Establishment of Maternal and Perinatal Database for Quality, Equity and Dignity programme: Processes, challenges, lessons and prospects.
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Adanikin A, Tukur J, Lavin T, Ezekwe B, Aminu I, Aboyeji P, Adesina O, Chama C, Etuk S, Galadanci H, Ikechebelu J, and Oladapo OT
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- Humans, Female, Pregnancy, Health Equity, Perinatal Care standards, Maternal Health Services standards, Databases, Factual
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- 2024
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16. Determinants of obstructed labour and associated outcomes in referral hospitals in Nigeria.
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Adelaiye S, Wanonyi I, Adanikin A, Mairiga A, Kadas A, Morrupa J, Lavin T, Lamara A, Yahaya I, Tukur J, and Chama C
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- Humans, Female, Pregnancy, Nigeria epidemiology, Adult, Retrospective Studies, Risk Factors, Young Adult, Prevalence, Maternal Mortality, Cesarean Section statistics & numerical data, Uterine Rupture epidemiology, Postpartum Hemorrhage epidemiology, Pregnancy Outcome epidemiology, Stillbirth epidemiology, Obstetric Labor Complications epidemiology, Referral and Consultation statistics & numerical data
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Objective: To estimate the prevalence of obstructed labour, associated risk factors and outcomes across a network of referral hospitals in Nigeria., Design: Retrospective observational study., Setting: A total of 54 referral-level hospitals across the six geopolitical regions of Nigeria., Population: Pregnant women who were diagnosed with obstructed labour during childbirth and subsequently underwent an emergency caesarean section between 1 September 2019 and 31 August 2020., Methods: Secondary analysis of routine maternity care data sets. Random-effects multivariable logistic regression was used to ascertain the factors associated with obstructed labour., Main Outcome Measures: Risk factors for obstructed labour and related postpartum complications, including intrapartum stillbirth, maternal death, uterine rupture, postpartum haemorrhage and sepsis., Results: Obstructed labour was diagnosed in 1186 (1.7%) women. Among these women, 31 (2.6%) cases resulted in maternal death and 199 (16.8%) cases resulted in postpartum complications. Women under 20 years of age (OR 2.03, 95% CI 1.50-2.75), who lacked formal education (OR 1.88, 95% CI 1.55-2.30), were unemployed (OR 1.94, 95% CI 1.57-2.41), were nulliparous (OR 2.11, 95% CI 1.83-2.43), did not receive antenatal care (OR 3.34, 95% CI 2.53-4.41) or received antenatal care in an informal healthcare setting (OR 8.18, 95% CI 4.41-15.14) were more likely to experience obstructed labour. Ineffective referral systems were identified as a major contributor to maternal death., Conclusions: Modifiable factors contributing to the prevalence of obstructed labour and associated adverse outcomes in Nigeria can be addressed through targeted policies and clinical interventions., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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17. Determinants and outcomes of preterm births in Nigerian tertiary facilities.
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Fajolu IB, Dedeke IOF, Oluwasola TA, Oyeneyin L, Imam Z, Ogundare E, Campbell I, Akinkunmi B, Ayegbusi EO, Agelebe E, Adefemi AK, Awonuga D, Jagun O, Salau Q, Kuti B, Tongo OO, Adebayo T, Adebanjo-Aina D, Adenuga E, Adewumi I, Lavin T, Tukur J, and Adesina O
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- Humans, Female, Pregnancy, Nigeria epidemiology, Infant, Newborn, Adult, Young Adult, Infant, Risk Factors, Prenatal Care statistics & numerical data, Maternal Age, Incidence, Infant, Premature, Premature Birth epidemiology, Perinatal Mortality, Tertiary Care Centers statistics & numerical data
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Objective: To describe the incidence, and sociodemographic and clinical factors associated with preterm birth and perinatal mortality in Nigeria., Design: Secondary analysis of data collected through the Maternal Perinatal Database for Quality, Equity and Dignity (MPD-4-QED) Programme., Setting: Data from births in 54 referral-level hospitals across Nigeria between 1 September 2019 and 31 August 2020., Population: A total of 69 698 births., Methods: Multilevel modelling was used to determine the factors associated with preterm birth and perinatal mortality., Outcome Measures: Preterm birth and preterm perinatal mortality., Results: Of 62 383 live births, 9547 were preterm (153 per 1000 live births). Maternal age (<20 years - adjusted odds ratio [aOR] 1.52, 95% CI 1.36-1.71; >35 years - aOR 1.23, 95% CI 1.16-1.30), no formal education (aOR 1.68, 95% CI 1.54-1.84), partner not gainfully employed (aOR 1.94, 95% CI 1.61-2.34) and no antenatal care (aOR 2.62, 95% CI 2.42-2.84) were associated with preterm births. Early neonatal mortality for preterm neonates was 47.2 per 1000 preterm live births (451/9547). Father's occupation (manual labour aOR 1.52, 95% CI 1.20-1.93), hypertensive disorders of pregnancy (aOR 1.37, 95% CI 1.02-1.83), no antenatal care (aOR 2.74, 95% CI 2.04-3.67), earlier gestation (28 to <32 weeks - aOR 2.94, 95% CI 2.15-4.10; 32 to <34 weeks - aOR 1.80, 95% CI 1.3-2.44) and birthweight <1000 g (aOR 21.35, 95% CI 12.54-36.33) were associated with preterm perinatal mortality., Conclusions: Preterm birth and perinatal mortality in Nigeria are high. Efforts should be made to enhance access to quality health care during pregnancy, delivery and the neonatal period, and improve the parental socio-economic status., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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18. Burden and outcomes of postpartum haemorrhage in Nigerian referral-level hospitals.
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Adebayo T, Adefemi A, Adewumi I, Akinajo O, Akinkunmi B, Awonuga D, Aworinde O, Ayegbusi E, Dedeke I, Fajolu I, Imam Z, Jagun O, Kuku O, Ogundare E, Oluwasola T, Oyeneyin L, Adebanjo-Aina D, Adenuga E, Adeyanju A, Akinsanya O, Campbell I, Kuti B, Olofinbiyi B, Salau Q, Tongo O, Ezekwe B, Lavin T, Oladapo OT, Tukur J, and Adesina O
- Subjects
- Humans, Female, Nigeria epidemiology, Pregnancy, Adult, Cross-Sectional Studies, Prevalence, Risk Factors, Delivery, Obstetric statistics & numerical data, Referral and Consultation statistics & numerical data, Young Adult, Infant, Newborn, Maternal Mortality, Cesarean Section statistics & numerical data, Pregnancy Outcome epidemiology, Postpartum Hemorrhage epidemiology, Postpartum Hemorrhage etiology
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Objective: To determine the prevalence of primary postpartum haemorrhage (PPH), risk factors, and maternal and neonatal outcomes in a multicentre study across Nigeria., Design: A secondary data analysis using a cross-sectional design., Setting: Referral-level hospitals (48 public and six private facilities)., Population: Women admitted for birth between 1 September 2019 and 31 August 2020., Methods: Data collected over a 1-year period from the Maternal and Perinatal Database for Quality, Equity and Dignity programme in Nigeria were analysed, stratified by mode of delivery (vaginal or caesarean), using a mixed-effects logistic regression model., Main Outcome Measures: Prevalence of PPH and maternal and neonatal outcomes., Results: Of 68 754 women, 2169 (3.2%, 95% CI 3.07%-3.30%) had PPH, with a prevalence of 2.7% (95% CI 2.55%-2.85%) and 4.0% (95% CI 3.75%-4.25%) for vaginal and caesarean deliveries, respectively. Factors associated with PPH following vaginal delivery were: no formal education (aOR 2.2, 95% CI 1.8-2.6, P < 0.001); multiple pregnancy (aOR 2.7, 95% CI 2.1-3.5, P < 0.001); and antepartum haemorrhage (aOR 11.7, 95% CI 9.4-14.7, P < 0.001). Factors associated with PPH in a caesarean delivery were: maternal age of >35 years (aOR 1.7, 95% CI 1.5-2.0, P < 0.001); referral from informal setting (aOR 2.4, 95% CI 1.4-4.0, P = 0.002); and antepartum haemorrhage (aOR 3.7, 95% CI 2.8-4.7, P < 0.001). Maternal mortality occurred in 4.8% (104/2169) of deliveries overall, and in 8.5% (101/1182) of intensive care unit admissions. One-quarter of all infants were stillborn (570/2307), representing 23.9% (429/1796) of neonatal intensive care unit admissions., Conclusions: A PPH prevalence of 3.2% can be reduced with improved access to skilled birth attendants., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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19. Incidence, predictors and immediate neonatal outcomes of birth asphyxia in Nigeria.
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Ikechebelu JI, Eleje GU, Onubogu CU, Ojiegbe NO, Ekwochi U, Ezebialu IU, Ezenkwele EP, Nzeribe EA, Umeh UA, Obumneme-Anyim I, Nwokeji-Onwe LN, Settecase E, Ugwu IA, Chianakwana O, Ibekwe NT, Ezeaku OI, Ekweagu GN, Onwe AB, Lavin T, and Tukur J
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- Humans, Female, Nigeria epidemiology, Pregnancy, Infant, Newborn, Incidence, Adult, Risk Factors, Young Adult, Male, Pregnancy Outcome epidemiology, Asphyxia Neonatorum epidemiology
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Objective: To determine the incidence and sociodemographic and clinical risk factors associated with birth asphyxia and the immediate neonatal outcomes of birth asphyxia in Nigeria., Design: Secondary analysis of data from the Maternal and Perinatal Database for Quality, Equity and Dignity Programme., Setting: Fifty-four consenting referral-level hospitals (48 public and six private) across the six geopolitical zones of Nigeria., Population: Women (and their babies) who were admitted for delivery in the facilities between 1 September 2019 and 31 August 2020., Methods: Data were extracted and analysed on prevalence and sociodemographic and clinical factors associated with birth asphyxia and the immediate perinatal outcomes. Multilevel logistic regression modelling was used to ascertain the factors associated with birth asphyxia., Main Outcome Measures: Incidence, case fatality rate and factors associated with birth asphyxia., Results: Of the available data, 65 383 (91.1%) women and 67 602 (90.9%) babies had complete data and were included in the analysis. The incidence of birth asphyxia was 3.0% (2027/67 602) and the case fatality rate was 16.8% (339/2022). The risk factors for birth asphyxia were uterine rupture, pre-eclampsia/eclampsia, abruptio placentae/placenta praevia, birth trauma, fetal distress and congenital anomaly. The following factors were independently associated with a risk of birth asphyxia: maternal age, woman's education level, husband's occupation, parity, antenatal care, referral status, cadre of health professional present at the birth, sex of the newborn, birthweight and mode of birth. Common adverse neonatal outcomes included: admission to a special care baby unit (SCBU), 88.4%; early neonatal death, 14.2%; neonatal sepsis, 4.5%; and respiratory distress, 4.4%., Conclusions: The incidence of reported birth asphyxia in the participating facilities was low, with around one in six or seven babies with birth asphyxia dying. Factors associated with birth asphyxia included sociodemographic and clinical considerations, underscoring a need for a comprehensive approach focused on the empowerment of women and ensuring access to quality antenatal, intrapartum and postnatal care., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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20. Maternal morbidity and death associated with pregnancy loss before 28 weeks in Nigeria.
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Etuk SJ, Orazulike N, Abasiattai AM, Omo-Aghoja LO, Njoku A, Ande AB, Uwagboe C, Igbarumah S, Ibrahim IA, Ekpebe P, Ochigbo S, Nyong EE, Ibeawuchi A, Idemudia E, Okagua J, Eigbedion A, Ezekwe B, Adeyemi OO, Lavin T, and Tukur J
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- Humans, Female, Nigeria epidemiology, Pregnancy, Adult, Cross-Sectional Studies, Prevalence, Young Adult, Risk Factors, Abortion, Induced statistics & numerical data, Abortion, Induced adverse effects, Abortion, Induced mortality, Abortion, Spontaneous epidemiology, Maternal Mortality
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Objective: To determine the prevalence of maternal morbidity and death from pregnancy loss before 28 weeks in referral-level hospitals in Nigeria., Design: Secondary analysis of a nationwide cross-sectional study., Setting: Fifty-four referral-level hospitals., Population: Women admitted for complications arising from pregnancy loss before 28 weeks between 1 September 2019 to 31 August 2020., Methods: Frequency and type of pregnancy loss were calculated using the extracted data. Multilevel logistic regression was used to determine sociodemographic and clinical factors associated with early pregnancy loss. Factors contributing to death were also analysed., Main Outcome Measures: Prevalence and outcome of pregnancy loss at <28 weeks; sociodemographic and clinical predictors of morbidity after early pregnancy loss; contributory factors to death., Results: Of the 4798 women who had pregnancy loss at <28 weeks of pregnancy, spontaneous abortion accounted for 49.2%, followed by missed abortion (26.9%) and ectopic pregnancy (15%). Seven hundred women (14.6%) had a complication following pregnancy loss and 99 women died (2.1%). Most complications (26%) and deaths (7%) occurred after induced abortion. Haemorrhage was the most frequent complication in all types of pregnancy loss with 11.5% in molar pregnancy and 6.9% following induced abortion. Predictors of complication or death were low maternal education, husband who was not gainfully employed, grand-multipara, pre-existing chronic medical condition and referral from another facility or informal setting., Conclusion: Pregnancy loss before 28 weeks is a significant contributor to high maternal morbidity and mortality in Nigeria. Socio-economic factors and delays in referral to higher levels of care contribute significantly to poor outcomes for women., (© 2024 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)
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- 2024
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21. Intrapartum antibiotic prophylaxis to prevent Group B streptococcal infections in newborn infants: a systematic review and meta-analysis comparing various strategies.
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Panneflek TJR, Hasperhoven GF, Chimwaza Y, Allen C, Lavin T, Te Pas AB, Bekker V, and van den Akker T
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Background: Early-onset Group B Streptococcus (EOGBS) infection leads to substantial morbidity and mortality in newborn infants. Intrapartum antibiotic prophylaxis (IAP) prevents EOGBS infection, but IAP strategies vary. The approach to the provision of IAP can be risk-based, universal or a combination of the two strategies. Previous systematic reviews reported that universal strategies might be most optimal in lowering EOGBS infection, but there is no consensus. Therefore, we aimed to provide up-to-date evidence on effectiveness of different strategies by comparing perinatal outcomes., Methods: A systematic search for EOGBS prevention strategies was performed in MEDLINE, Embase and Web of Science on May 2024. Studies were included if they reported on different strategies and outcomes of interest, including EOGBS infection, IAP administration and antimicrobial resistance regardless of publication date. Summary data was extracted from published reports. Study quality was assessed using the ROBINS-I tool. Random-effects meta-analyses were used to determine risk ratios (RR) and 95%-confidence intervals. PROSPERO registration CRD42023411806., Findings: A total of 6293 records were identified, of which 72 observational studies were included for synthesis with more than 10 million live births. Meta-analysis demonstrated that implementation of any strategy (n = 34 studies, RR 0.46 (0.36-0.60)), risk-based strategies (n = 11 studies, RR 0.65 (0.48-0.87)), or universal strategies (n = 16 studies, RR 0.37 (0.25-0.55)) was associated with a reduced risk of EOGBS infection compared to no strategy. In direct comparison, universal strategies were associated with a reduced risk of EOGBS compared to a risk-based strategy (n = 17 studies, RR 0.41 (0.30-0.55)), while the proportion of women receiving IAP did not differ between risk-based (16%) and universal (21%) strategies (n = 9 studies, RR 1.29 (0.95-1.75)). There was no antimicrobial resistance of EOGBS isolates to penicillin or ampicillin (n = 11 studies)., Interpretation: Any IAP strategy could reduce the risk of EOGBS infection without evidence of increasing antimicrobial resistance. Universal strategies give the largest reduction in the EOGBS burden, while not exposing a significantly higher proportion of pregnancies to IAP compared to risk-based strategies., Funding: UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, a cosponsored programme executed by the World Health Organization., Competing Interests: Authors have no competing or conflicts of interests to declare., (© 2024 The Author(s).)
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- 2024
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22. Nutritional Challenges among African Refugee and Internally Displaced Children: A Comprehensive Scoping Review.
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Gooding C, Musa S, Lavin T, Sibeko L, Ndikom CM, Iwuagwu S, Ani-Amponsah M, Maduforo AN, and Salami B
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Background: Children's nutrition in Africa, especially among those displaced by conflicts, is a critical global health concern. Adequate nutrition is pivotal for children's well-being and development, yet those affected by displacement confront distinctive challenges. This scoping review seeks to enhance our current knowledge, filling gaps in understanding nutritional and associated health risks within this vulnerable population., Objective: We conducted a scoping review of the literature on the nutritional status and associated health outcomes of this vulnerable population with the goal of informing targeted interventions, policy development, and future research efforts to enhance the well-being of African refugee and internally displaced children., Methods: This scoping review adopted Arksey and O'Malley (2005)'s methodology and considered studies published between 2000 and 2021., Results: Twenty-three published articles met the inclusion criteria. These articles highlighted a wide variation in the levels of malnutrition among African refugee/internally displaced (IDP) children, with the prevalence of chronic malnutrition (stunting) and acute malnutrition (wasting) ranging from 18.8 to 52.1% and 0.04 to 29.3%, respectively. Chronic malnutrition was of 'high' or 'very high' severity (according to recent WHO classifications) in 80% of studies, while acute malnutrition was of 'high' or 'very high' severity in 50% of studies. In addition, anemia prevalence was higher than the 40% level considered to indicate a severe public health problem in 80% of the studies reviewed., Conclusion: In many settings, acute, chronic, and micronutrient malnutrition are at levels of great concern. Many countries hosting large, displaced populations are not represented in the literature, and research among older children is also lacking. Qualitative and intervention-focused research are urgently needed.
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- 2024
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23. Neglected medium-term and long-term consequences of labour and childbirth: a systematic analysis of the burden, recommended practices, and a way forward.
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Vogel JP, Jung J, Lavin T, Simpson G, Kluwgant D, Abalos E, Diaz V, Downe S, Filippi V, Gallos I, Galadanci H, Katageri G, Homer CSE, Hofmeyr GJ, Liabsuetrakul T, Morhason-Bello IO, Osoti A, Souza JP, Thakar R, Thangaratinam S, and Oladapo OT
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- Pregnancy, Female, Humans, Delivery, Obstetric, Parturition, Labor, Obstetric
- Abstract
Over the past three decades, substantial progress has been made in reducing maternal mortality worldwide. However, the historical focus on mortality reduction has been accompanied by comparative neglect of labour and birth complications that can emerge or persist months or years postnatally. This paper addresses these overlooked conditions, arguing that their absence from the global health agenda and national action plans has led to the misconception that they are uncommon or unimportant. The historical limitation of postnatal care services to the 6 weeks after birth is also a contributing factor. We reviewed epidemiological data on medium-term and long-term complications arising from labour and childbirth beyond 6 weeks, along with high-quality clinical guidelines for their prevention, identification, and treatment. We explore the complex interplay of human evolution, maternal physiology, and inherent predispositions that contribute to these complications. We offer actionable recommendations to change the current trajectories of these neglected conditions and help achieve the targets of Sustainable Development Goal 3. This paper is the third in a Series of four papers about maternal health in the perinatal period and beyond., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 World Health Organization. Published by Elsevier Ltd. All rights reserved. This is an Open Access article published under the CC BY 3.0 IGO license which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.)
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- 2024
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24. National, regional, and global estimates of preterm birth in 2020, with trends from 2010: a systematic analysis.
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Ohuma EO, Moller AB, Bradley E, Chakwera S, Hussain-Alkhateeb L, Lewin A, Okwaraji YB, Mahanani WR, Johansson EW, Lavin T, Fernandez DE, Domínguez GG, de Costa A, Cresswell JA, Krasevec J, Lawn JE, Blencowe H, Requejo J, and Moran AC
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- Child, Female, Humans, Infant, Infant, Newborn, Bayes Theorem, Birth Rate, Global Health, Infant Mortality, Infant, Low Birth Weight, Premature Birth epidemiology
- Abstract
Background: Preterm birth is the leading cause of neonatal mortality and is associated with long-term physical, neurodevelopmental, and socioeconomic effects. This study updated national preterm birth rates and trends, plus novel estimates by gestational age subgroups, to inform progress towards global health goals and targets, and aimed to update country, regional, and global estimates of preterm birth for 2020 in addition to trends between 2010 and 2020., Methods: We systematically searched population-based, nationally representative data on preterm birth from Jan 1, 2010, to Dec 31, 2020 and study data (26 March-14 April, 2021) for countries and areas with no national-level data. The analysis included 679 data points (86% nationally representative administrative data [582 of 679 data points]) from 103 countries and areas (62% of countries and areas having nationally representative administrative data [64 of 103 data points]). A Bayesian hierarchical regression was used for estimating country-level preterm rates, which incoporated country-specific intercepts, low birthweight as a covariate, non-linear time trends, and bias adjustments based on a data quality categorisation, and other indicators such as method of gestational age estimation., Findings: An estimated 13·4 million (95% credible interval [CrI] 12·3-15·2 million) newborn babies were born preterm (<37 weeks) in 2020 (9·9% of all births [95% CrI 9·1-11·2]) compared with 13·8 million (12·7-15·5 million) in 2010 (9·8% of all births [9·0-11·0]) worldwide. The global annual rate of reduction was estimated at -0·14% from 2010 to 2020. In total, 55·6% of total livebirths are in southern Asia (26·8% [36 099 000 of 134 767 000]) and sub-Saharan Africa (28·7% [38 819 300 of 134 767 000]), yet these two regions accounted for approximately 65% (8 692 000 of 13 376 200) of all preterm births globally in 2020. Of the 33 countries and areas in the highest data quality category, none were in southern Asia or sub-Saharan Africa compared with 94% (30 of 32 countries) in high-income countries and areas. Worldwide from 2010 to 2020, approximately 15% of all preterm births occurred at less than 32 weeks of gestation, requiring more neonatal care (<28 weeks: 4·2%, 95% CI 3·1-5·0, 567 800 [410 200-663 200 newborn babies]); 28-32 weeks: 10·4% [9·5-10·6], 1 392 500 [1 274 800-1 422 600 newborn babies])., Interpretation: There has been no measurable change in preterm birth rates over the last decade at global level. Despite increasing facility birth rates and substantial focus on routine health data systems, there remain many missed opportunities to improve preterm birth data. Gaps in national routine data for preterm birth are most marked in regions of southern Asia and sub-Saharan Africa, which also have the highest estimated burden of preterm births. Countries need to prioritise programmatic investments to prevent preterm birth and to ensure evidence-based quality care when preterm birth occurs. Investments in improving data quality are crucial so that preterm birth data can be improved and used for action and accountability processes., Funding: The Children's Investment Fund Foundation and the UNDP, United Nations Population Fund-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2023 World Health Organization. Published by Elsevier Ltd. All rights reserved. This is an Open Access article published under the CC BY 3.0 IGO license which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.)
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- 2023
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25. Antenatal corticosteroids in specific groups at risk of preterm birth: a systematic review.
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Saito K, Nishimura E, Ota E, Namba F, Swa T, Ramson J, Lavin T, Cao J, and Vogel JP
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- Infant, Newborn, Pregnancy, Humans, Female, Cesarean Section, Adrenal Cortex Hormones therapeutic use, Fetal Growth Retardation, Chorioamnionitis, Premature Birth prevention & control, Diabetes, Gestational drug therapy
- Abstract
Objective: This study aimed to synthesise available evidence on the efficacy of antenatal corticosteroid (ACS) therapy among women at risk of imminent preterm birth with pregestational/gestational diabetes, chorioamnionitis or fetal growth restriction (FGR), or planned caesarean section (CS) in the late preterm period., Methods: A systematic search of MEDLINE, EMBASE, CINAHL, Cochrane Library, Web of Science and Global Index Medicus was conducted for all comparative randomised or non-randomised interventional studies in the four subpopulations on 6 June 2021. Risk of Bias Assessment tool for Non-randomised Studies and the Cochrane Risk of Bias tool were used to assess the risk of bias. Grading of Recommendations Assessment, Development and Evaluations tool assessed the certainty of evidence., Results: Thirty-two studies involving 5018 pregnant women and 10 819 neonates were included. Data on women with diabetes were limited, and evidence on women undergoing planned CS was inconclusive. ACS use was associated with possibly reduced odds of neonatal death (pooled OR: 0.51; 95% CI: 0.31 to 0.85, low certainty), intraventricular haemorrhage (pooled OR: 0.41; 95% CI: 0.23 to 0.72, low certainty) and respiratory distress syndrome (pooled OR: 0.59; 95% CI: 0.45 to 0.77, low certainty) in women with chorioamnionitis. Among women with FGR, the rates of surfactant use (pooled OR: 0.38; 95% CI: 0.23 to 0.62, moderate certainty), mechanical ventilation (pooled OR: 0.42; 95% CI: 0.26 to 0.66, moderate certainty) and oxygen therapy (pooled OR: 0.48; 95% CI: 0.30 to 0.77, moderate certainty) were probably reduced; however, the rate of hypoglycaemia probably increased (pooled OR: 2.06; 95% CI: 1.27 to 3.32, moderate certainty)., Conclusions: There is a paucity of evidence on ACS for women who have diabetes. ACS therapy may have benefits in women with chorioamnionitis and is probably beneficial in FGR. There is limited direct trial evidence on ACS efficacy in women undergoing planned CS in the late preterm period, though the totality of evidence suggests it is probably beneficial., Prospero Registration Number: CRD42021267816., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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26. Effect of antenatal corticosteroid administration-to-birth interval on maternal and newborn outcomes: a systematic review.
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McDougall ARA, Aboud L, Lavin T, Cao J, Dore G, Ramson J, Oladapo OT, and Vogel JP
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Background: Antenatal corticosteroids (ACS) are highly effective at improving outcomes for preterm newborns. Evidence suggests the benefits of ACS may vary with the time interval between administration-to-birth. However, the optimal ACS administration-to-birth interval is not yet known. In this systematic review, we synthesised available evidence on the relationship between ACS administration-to-birth interval and maternal and newborn outcomes., Methods: This review was registered with PROSPERO (CRD42021253379). We searched Medline, Embase, CINAHL, Cochrane Library, Global Index Medicus on 11 Nov 2022 with no date or language restrictions. Randomised and non-randomised studies of pregnant women receiving ACS for preterm birth where maternal and newborn outcomes were reported for different administration-to-birth intervals were eligible. Eligibility screening, data extraction and risk of bias assessment were performed by two authors independently. Fetal and neonatal outcomes included perinatal and neonatal mortality, preterm birth-related morbidity outcomes and mean birthweight. Maternal outcomes included chorioamnionitis, maternal mortality, endometritis, and maternal intensive care unit admission., Findings: Ten trials (4592 women; 5018 neonates), 45 cohort studies (at least 22,992 women; 30,974 neonates) and two case-control studies (355 women; 360 neonates) met the eligibility criteria. Across studies, 37 different time interval combinations were identified. There was considerable heterogeneity in included administration-to-birth intervals and populations. The odds of neonatal mortality, respiratory distress syndrome and intraventricular haemorrhage were associated with the ACS administration-to-birth interval. However, the interval associated with the greatest improvements in newborn outcomes was not consistent across studies. No reliable data were available for maternal outcomes, though odds of chorioamnionitis might be associated with longer intervals., Intepretation: An optimal ACS administration-to-birth interval likely exists, however variations in study design limit identification of this interval from available evidence. Future research should consider advanced analysis techniques such as individual patient data meta-analysis to identify which ACS administration-to-birth intervals are most beneficial, and how these benefits can be optimised for women and newborns., Funding: This study was conducted with funding support from the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research (SRH), a co-sponsored programme executed by the World Health Organization., Competing Interests: Authors have no competing interests to declare., (© 2023 World Health Organization.)
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- 2023
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27. Radiation treatment of benign tumors in NF2-related-schwannomatosis: A national study of 266 irradiated patients showing a significant increase in malignancy/malignant progression.
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Evans DG, Halliday D, Obholzer R, Afridi S, Forde C, Rutherford SA, Hammerbeck-Ward C, Lloyd SK, Freeman SM, Pathmanaban ON, Thomas OM, Laitt RD, Stivaros S, Kilday JP, Vassallo G, McBain C, Lavin T, Paterson C, Whitfield G, McCabe MG, Axon PR, Halliday J, Mackeith S, Parry A, Harkness EF, Buttimore J, and King AT
- Abstract
Background: Radiation treatment of benign tumors in tumor predisposition syndromes is controversial, but short-term studies from treatment centers suggest safety despite apparent radiation-associated malignancy being reported. We determined whether radiation treatment in NF2-related schwannomatosis patients is associated with increased rates of subsequent malignancy (M)/malignant progression (MP)., Methods: All UK patients with NF2 were eligible if they had a clinical/molecular diagnosis. Cases were NF2 patients treated with radiation for benign tumors. Controls were matched for treatment location with surgical/medical treatments based on age and year of treatment. Prospective data collection began in 1990 with addition of retrospective cases in 1969. Kaplan-Meier analysis was performed for malignancy incidence and survival. Outcomes were central nervous system (CNS) M/MP (2cm annualized diameter growth) and survival from index tumor treatment., Results: In total, 1345 NF2 patients, 266 (133-Male) underwent radiation treatments between 1969 and 2021 with median first radiotherapy age of 32.9 (IQR = 22.4-46.0). Nine subsequent CNS malignancies/MPs were identified in cases with only 4 in 1079 untreated ( P < .001). Lifetime and 20-year CNS M/MP was ~6% in all irradiated patients-(4.9% for vestibular schwannomas [VS] radiotherapy) versus <1% in the non-irradiated population ( P < .001/.01). Controls were well matched for age at NF2 diagnosis and treatment (Males = 133%-50%) and had no M/MP in the CNS post-index tumor treatment ( P = .0016). Thirty-year survival from index tumor treatment was 45.62% (95% CI = 34.0-56.5) for cases and 66.4% (57.3-74.0) for controls ( P = .02), but was nonsignificantly worse for VS radiotherapy., Conclusion: NF2 patients should not be offered radiotherapy as first-line treatment of benign tumors and should be given a frank discussion of the potential 5% excess absolute risk of M/MP., Competing Interests: None other than many of the authors are surgeons, but 4 are oncologists., (© The Author(s) 2023. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.)
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- 2023
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28. Truncating Variants in RFC1 in Cerebellar Ataxia, Neuropathy, and Vestibular Areflexia Syndrome.
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Ronco R, Perini C, Currò R, Dominik N, Facchini S, Gennari A, Simone R, Stuart S, Nagy S, Vegezzi E, Quartesan I, El-Saddig A, Lavin T, Tucci A, Szymura A, Novis De Farias LE, Gary A, Delfeld M, Kandikatla P, Niu N, Tawde S, Shaw J, Polke J, Reilly MM, Wood NW, Crespan E, Gomez C, Chen JYH, Schmahmann JD, Gosal D, Houlden H, Das S, and Cortese A
- Subjects
- Adult, Humans, Syndrome, Cerebellar Ataxia genetics, Cerebellar Ataxia diagnosis, Bilateral Vestibulopathy genetics, Bilateral Vestibulopathy diagnosis, Neurodegenerative Diseases, Vestibular Diseases genetics, Peripheral Nervous System Diseases
- Abstract
Background and Objective: Cerebellar ataxia, neuropathy, and vestibular areflexia syndrome (CANVAS) is an autosomal recessive neurodegenerative disease characterized by adult-onset and slowly progressive sensory neuropathy, cerebellar dysfunction, and vestibular impairment. In most cases, the disease is caused by biallelic (AAGGG)
n repeat expansions in the second intron of the replication factor complex subunit 1 ( RFC1 ). However, a small number of cases with typical CANVAS do not carry the common biallelic repeat expansion. The objective of this study was to expand the genotypic spectrum of CANVAS by identifying sequence variants in RFC1 -coding region associated with this condition., Methods: Fifteen individuals diagnosed with CANVAS and carrying only 1 heterozygous (AAGGG)n expansion in RFC1 underwent whole-genome sequencing or whole-exome sequencing to test for the presence of a second variant in RFC1 or other unrelated gene. To assess the effect of truncating variants on RFC1 expression, we tested the level of RFC1 transcript and protein on patients' derived cell lines., Results: We identified 7 patients from 5 unrelated families with clinically defined CANVAS carrying a heterozygous (AAGGG)n expansion together with a second truncating variant in trans in RFC1 , which included the following: c.1267C>T (p.Arg423Ter), c.1739_1740del (p.Lys580SerfsTer9), c.2191del (p.Gly731GlufsTer6), and c.2876del (p.Pro959GlnfsTer24). Patient fibroblasts containing the c.1267C>T (p.Arg423Ter) or c.2876del (p.Pro959GlnfsTer24) variants demonstrated nonsense-mediated mRNA decay and reduced RFC1 transcript and protein., Discussion: Our report expands the genotype spectrum of RFC1 disease. Full RFC1 sequencing is recommended in cases affected by typical CANVAS and carrying monoallelic (AAGGG)n expansions. In addition, it sheds further light on the pathogenesis of RFC1 CANVAS because it supports the existence of a loss-of-function mechanism underlying this complex neurodegenerative condition., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.)- Published
- 2023
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29. The forms and adverse effects of insecurities among internally displaced children in Ethiopia.
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Kemei J, Salami BO, Soboka M, Gommaa HIM, Okeke-Ihejirika P, and Lavin T
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- Humans, Child, Ethiopia epidemiology, Parents, Violence psychology, Mental Health, Housing
- Abstract
Background: Ethiopia has seen an increase in the number of internally displaced persons (IDPs) due to conflict and violence related to border-based disputes and climate change. This study examines the insecurities experienced by IDPs in the Burayu camp and how they navigate and challenge them. Violence and insecurity have daunted Ethiopian regions for decades, violated children's rights, and impeded the achievement of the United Nation's sustainable development goals related to children, such as good healthcare and mental health, quality education, clean water, and sanitation. The deteriorating security concerns in Ethiopia could also expose IDP children to poor health outcomes associated with a lack of access to healthcare services., Methods: This was an exploratory qualitative case study guided by intersectionality theoretical lens to explore the forms of insecurities perceived and experienced by IDPs in Ethiopia. Participants were selected using a purposeful sampling approach. We interviewed 20 children, 20 parents or guardians, and 13 service providers. Interviews were audio recorded and transcribed verbatim in Afan Oromo, then translated into English. We used NVivo 12 qualitative data analysis software to analyze data following Braun & Clarke's approach to thematic data analysis., Results: The participants reported that IDP children in Burayu town faced many challenges related to poor socioeconomic conditions that exposed them to several insecurities and negatively affected their well-being. They reported inadequate access to clothing and shelter, clean water, sanitary facilities, food, and adequate healthcare due to financial barriers, lack of drugs, and quality of care. Our data analysis shows that socioeconomic and contextual factors intersect to determine the health and well-being of children in the Ethiopian IDP camp studied. The children experienced insecurities while navigating their daily lives. This is compounded by institutional practices that shape gender relations, income status, and access to healthcare, education, and food. These deficiencies expose children to traumatic events that could decrease future livelihood prospects and lead to compromised mental health, rendering them susceptible to prolonged post-traumatic stress disorder and depression. Results are presented under the following topics: (1) basic needs insecurity, (2) healthcare insecurity, (3) academic insecurity, (4) economic insecurity, (5) food insecurity, and (6) physical and mental health insecurity., Conclusion: Successful relocation and reintegration of IDPs would help to alleviate both parent and child post-conflict stressors. Managing and following up on economic reintegration efforts is needed in both the short and long term. Such measures will help to achieve goals for specific projects attached to donor support outcomes, consequently enabling social support and conflict resolution management efforts., (© 2023. The Author(s).)
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- 2023
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30. Rasch-built overall disability scale for POEMS syndrome (POEMS-RODS).
- Author
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Keh RYS, Lilleker JB, Lavin T, Sive J, D'Sa S, Ramdharry G, Carr AS, and Lunn MP
- Subjects
- Humans, Reproducibility of Results, Surveys and Questionnaires, Severity of Illness Index, POEMS Syndrome diagnosis, Disabled Persons
- Abstract
Patient-reported outcome measures engage patients in disease severity measurement and the metrics reported can be meaningful to their lives. The Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein and Skin changes syndrome (POEMS) is a complex multisystem disorder with disabling neuropathy which is distinct from other acquired inflammatory neuropathies. No current POEMS-specific validated disability scales exist. To address this, we have produced a Rasch-built overall disability scale (RODS) specific to POEMS. A 146-item preliminary questionnaire containing relevant activity and participation items for neuropathic disability was applied to 49 clinically stable patients with POEMS from the UK national POEMS cohort. A total of 123 items not fulfilling Rasch model expectations were sequentially removed. The final 23-item POEMS-RODS fulfilled Rasch model expectations and showed acceptable test-retest reliability. The 23-item POEMS-RODS is a disease-specific patient-reported outcome measure able to detect activity limitations within the range of ability demonstrated by the UK POEMS cohort. Larger international studies are needed to confirm the broader applicability and responsiveness of this scale in other countries., (© 2022 The Authors. Journal of the Peripheral Nervous System published by Wiley Periodicals LLC on behalf of Peripheral Nerve Society.)
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- 2022
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31. Pragmatic guide to peripheral nerve disease and the role of clinical biomarkers.
- Author
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Keh RYS, Shah S, Lilleker JB, Lavin T, Morrow J, Carr AS, and Lunn MP
- Abstract
In clinical neurology practice, there are few sensitive, specific and responsive serological biomarkers reflecting pathological processes affecting the peripheral nervous system. Instead, we rely on surrogate multimodality biomarkers for diagnosis and management. Correct use and interpretation of the available tests is essential to ensure that appropriate treatments are used and adjusted in a timely fashion. The incorrect application or interpretation of biomarkers can result in misdiagnosis and delays in appropriate treatment. Here, we discuss the uses and limitations of such biomarkers and discuss possible future developments., Competing Interests: Competing interests: No specific funding was received for this work. MPL, ASC and JM are supported by the National Institute for Health Research, University College London Hospitals NHS Foundation Trust and Biomedical Research Centre. RYSK is funded by GBS‐CIDP Foundation International., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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32. Quality and outcomes of maternal and perinatal care for 76,563 pregnancies reported in a nationwide network of Nigerian referral-level hospitals.
- Author
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Tukur J, Lavin T, Adanikin A, Abdussalam M, Bankole K, Ekott MI, Godwin A, Ibrahim HA, Ikechukwu O, Kadas SA, Nwokeji-Onwe L, Nzeribe E, Ogunkunle TO, Oyeneyin L, Tunau KA, Bello M, Aminu I, Ezekwe B, Aboyeji P, Adesina OA, Chama C, Etuk S, Galadanci H, Ikechebelu J, and Oladapo OT
- Abstract
Background: The WHO in collaboration with the Nigeria Federal Ministry of Health, established a nationwide electronic data platform across referral-level hospitals. We report the burden of maternal, foetal and neonatal complications and quality and outcomes of care during the first year., Methods: Data were analysed from 76,563 women who were admitted for delivery or on account of complications within 42 days of delivery or termination of pregnancy from September 2019 to August 2020 across the 54 hospitals included in the Maternal and Perinatal Database for Quality, Equity and Dignity programme., Findings: Participating hospitals reported 69,055 live births, 4,498 stillbirths and 1,090 early neonatal deaths. 44,614 women (58·3%) had at least one pregnancy complication, out of which 6,618 women (8·6%) met our criteria for potentially life-threatening complications, and 940 women (1·2%) died. Leading causes of maternal death were eclampsia ( n = 187,20·6%), postpartum haemorrhage (PPH) ( n = 103,11·4%), and sepsis ( n = 99,10·8%). Antepartum hypoxia ( n = 1455,31·1%) and acute intrapartum events ( n = 913,19·6%) were the leading causes of perinatal death. Predictors of maternal and perinatal death were similar: low maternal education, lack of antenatal care, referral from other facility, previous caesarean section, latent-phase labour admission, operative vaginal birth, non-use of a labour monitoring tool, no labour companion, and non-use of uterotonic for PPH prevention., Interpretation: This nationwide programme for routine data aggregation shows that maternal and perinatal mortality reduction strategies in Nigeria require a multisectoral approach. Several lives could be saved in the short term by addressing key predictors of death, including gaps in the coverage of internationally recommended interventions such as companionship in labour and use of labour monitoring tool., Funding: This work was funded by MSD for Mothers; and UNDP/UNFPA/ UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a co-sponsored programme executed by the World Health Organization (WHO)., Competing Interests: The authors declare no competing interests., (© 2022 World Health Organization.)
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- 2022
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33. Predicting long-term trends in inflammatory neuropathy outcome measures using latent class modelling.
- Author
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Keh RYS, Selby DA, Jones S, Gosal D, Lavin T, Lilleker JB, Carr AS, and Lunn MP
- Subjects
- Hand Strength, Humans, Immunoglobulins, Outcome Assessment, Health Care, Retrospective Studies, Polyneuropathies, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating drug therapy
- Abstract
Immunoglobulin (Ig) is used to treat chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy with conduction block (MMNCB). Regular infusions may be used for symptom control. Disease activity is monitored with clinical outcome measurements. We examined outcome measure variation during clinically stable periods in Ig-treated CIDP and MMNCB patients. We explored utility of serial outcome measurement in long-term outcome prediction. Retrospective longitudinal analysis of a single neuroscience centre's Ig-treated CIDP and MMNCB patients, 2009-2020, was performed. Mean and percentage change for grip strength, Rasch-built overall disability scales (RODS) and MRC sum scores (MRC-SS) during periods of clinical stability were compared to score-specific minimal clinically important differences (MCID). Latent class mixed modelling (LCMM) was used to identify longitudinal trends and factors influencing long-term outcome. We identified 85 CIDP and 23 MMNCB patients (1423 datapoints; 5635 treatment-months). Group-averaged outcome measures varied little over time. Intra-individual variation exceeded MCID for RODS in 44.2% CIDP and 16.7% MMNCB datapoints, grip strength in 10.6% (CIDP) and 8.8%/27.2% (MMNCB right/left hand) and MRC-SS in 43.5% (CIDP) and 20% (MMNCB). Multivariate LCMM identified subclinical trends towards improvement (32 patients) and deterioration (73 patients) in both cohorts. At baseline, CIDP 'deteriorators' were older than 'improvers' (66.2 vs 57 years, P = .025). No other individual factors predicted categorisation. The best model for 'deteriorator' identification was contiguous sub-MCID decline in more than one outcome measure (CIDP: sensitivity 74%, specificity 59%; MMNCB: sensitivity 73%, specificity 88%). Outcome measure interpretation determines therapeutic decision-making in Ig-dependent neuropathy patients, but intra-individual variation is common, often exceeding MCID. Here we show sub-MCID contiguous changes in more than one outcome measurement are a better predictor of long-term outcome., (© 2021 Peripheral Nerve Society.)
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- 2022
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34. Hereditary transthyretin amyloidosis presenting with neuropathy and a bullous rash.
- Author
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Keh RY, Fitzgerald D, Green R, Roncaroli F, and Lavin T
- Subjects
- Humans, Prealbumin genetics, Amyloid Neuropathies, Familial diagnosis, Exanthema diagnosis, Exanthema etiology
- Published
- 2022
- Full Text
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