Skip to content
World Today News
  • Business
  • Entertainment
  • Health
  • News
  • Sport
  • Technology
  • World
World Today News
  • Business
  • Entertainment
  • Health
  • News
  • Sport
  • Technology
  • World
Friday, December 5, 2025
World Today News
World Today News
  • Business
  • Entertainment
  • Health
  • News
  • Sport
  • Technology
  • World
Copyright 2021 - All Right Reserved
Home » Medicine/Public Health » Page 2
Tag:

Medicine/Public Health

Health

The Royal College of Ophthalmologists’ National Ophthalmology Database study of cataract surgery: report 20, the hidden cost of intraocular lens choices for National Health Service funded cataract surgery in England

by Dr. Michael Lee – Health Editor October 4, 2025
written by Dr. Michael Lee – Health Editor

NHS Cataract Surgery Costs Rise Due⁤ to IOL Choices, New Data ‍Reveals

A new​ report ‍from ⁤The Royal College of Ophthalmologists’ National Ophthalmology Database⁤ (NOD) ⁢study reveals critically important hidden costs associated with intraocular lens ‍(IOL) choices during NHS-funded cataract surgery in England. Report 20, published⁣ in Eye in⁤ November 2023, ​demonstrates that while‍ the overall cost of cataract surgery remains relatively ‍stable, variations in IOL selection contribute ⁢to ​substantial financial discrepancies-potentially reaching £11.5 million annually.

the study, analyzing data from over 580,000 cataract⁢ surgeries performed between April 2018 and March 2023, highlights that the use of more expensive IOLs, notably those offering multifocal‌ or toric correction, drives up costs without‌ necessarily improving patient outcomes for‍ all.This impacts the National Health Service budget and ⁣raises questions about⁤ equitable access to⁤ advanced lens technology, as well as the value proposition of these lenses given their associated costs. The findings underscore the need for standardized guidelines and informed consent processes to ensure appropriate IOL ​selection aligned with individual patient needs and visual goals.

researchers found that the average cost of cataract surgery, including the IOL, was £928. However, the cost varied⁣ significantly depending on the ‌type of IOL used. ​Monofocal IOLs, providing clear distance vision, were the least expensive, while multifocal ‍and toric ⁤IOLs-designed to correct astigmatism and reduce reliance on glasses-added substantially to the overall expense. The report estimates that ‌if ‍all patients received monofocal IOLs, the NHS could save⁣ approximately £6.8 million per year. Further ⁢savings, potentially reaching £11.5 million annually,could be realized by ⁤optimizing IOL utilization and reducing instances where more expensive lenses are used without clear clinical justification.

The NOD study also examined the incidence ⁤of Nd:YAG laser capsulotomy⁤ following cataract surgery,finding a rate of 14.2% overall.‌ A ⁢separate population-based study, FreYAG1, published in BMC Ophthalmology in 2023, reported a similar incidence of 14.1% following cataract ​surgery, reinforcing the need for ongoing monitoring of post-operative complications and ​their associated costs. These findings, combined with the IOL cost analysis, paint a comprehensive picture of the economic burden ‍of cataract‍ surgery and the importance of evidence-based ‍decision-making in optimizing resource allocation within the NHS.

October 4, 2025 0 comments
0 FacebookTwitterPinterestEmail
Health

Promoting healthy lifestyle behaviours in the preschool setting: perceptions and needs of teachers and principals | BMC Public Health

by Dr. Michael Lee – Health Editor September 9, 2025
written by Dr. Michael Lee – Health Editor

Preschool Teachers Key to Boosting Young Children‘s Activity Levels, Study Finds

New york, NY – Preschool ⁤teachers play a pivotal role in fostering physical activity in young children, according to new research highlighting the ​importance of ⁣educator engagement⁤ and a supportive learning environment. The‌ study underscores that teachers ​aren’t just facilitators ‍ of ‌activity,

September 9, 2025 0 comments
0 FacebookTwitterPinterestEmail
Health

Birth weight in relation to maternal and neonatal biomarker concentration of perfluorooctane sulfonic acid: a meta-analysis and meta-regression from a systematic review

by Dr. Michael Lee – Health Editor August 23, 2025
written by Dr. Michael Lee – Health Editor
  • Jarvis AL, Justice JR, Elias MC, Schnitker B, Gallagher K. Perfluorooctane sulfonate in US ambient surface waters: a review of occurrence in aquatic environments and comparison to global concentrations. Environ Toxicol Chem. 2021;40:2425–42.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • U.S. EPA 2024a. Final Human Health Toxicity Assessment for Perfluorooctane Sulfonic Acid (PFOS) and Related Salts. U.S. EPA Office of Water, Washington, DC. EPA Document No. 815-R-24-007. April 2024.

  • Dzierlenga MW, Crawford L, Longnecker MP. Birth weight and perfluorooctane sulfonic acid: a random-effects meta-regression analysis. Environ Epidemiol. 2020;4:e095.

    PubMed
    PubMed Central

    Google Scholar

  • U.S. EPA, 2022. ORD Staff Handbook for Developing IRIS Assessments. U.S. EPA Office of Research and Development, Washington, DC. EPA/600/R-22/268. https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=356370.

  • U.S. EPA, 2021. Systematic Review Protocol for the PFAS IRIS Assessments. U.S. Environmental Protection Agency, Washington, DC. EPA/635/R-19/050. http://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=345065.

  • Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg. 2010;8:336–41.

    PubMed

    Google Scholar

  • U.S. EPA 2024b. Appendix—office of water final human health toxicity assessment for Perfluorooctane Sulfonic Acid (PFOS). 815–R–24–009. https://www.epa.gov/system/files/documents/2024-05/appendix-final-human-health-toxicity-assessment-pfos.pdf.

  • U.S. EPA, 2016. Drinking water health advisory for perfluorooctane sulfonate (PFOS). Office of Water, Health and Ecological Criteria Division. EPA Document No. 822-R-16-004.

  • U.S. EPA. 2024c. Toxicological review of Perfluorodecanoic Acid (PFDA) and related salts (Final Report, 2024). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-24/172Fa, 2024.

  • Gardener H, Sun Q, Grandjean P. PFAS concentration during pregnancy in relation to cardiometabolic health and birth outcomes. Environ Res. 2021;192:110287.

    CAS
    PubMed

    Google Scholar

  • Yao Q, Gao Y, Zhang Y, Qin K, Liew Z, Tian Y. Associations of paternal and maternal per- and polyfluoroalkyl substances exposure with cord serum reproductive hormones, placental steroidogenic enzyme and birth weight. Chemosphere. 2021;285:131521.

    CAS
    PubMed

    Google Scholar

  • Rohatgi A. WebPlotDigitizer version 4.6, Pacifica, CA, USA. https://plotdigitizer.com/. 2022.

  • Ehresman DJ, Froehlich JW, Olsen GW, Chang SC, Butenhoff JL. Comparison of human whole blood, plasma, and serum matrices for the determination of perfluorooctanesulfonate (PFOS), perfluorooctanoate (PFOA), and other fluorochemicals. Environ Res. 2007;103:176–84.

    CAS
    PubMed

    Google Scholar

  • Barr DB, Kannan K, Cui Y, Merrill L, Petrick LM, Meeker JD, et al. The use of dried blood spots for characterizing children’s exposure to organic environmental chemicals. Environ Res. 2021;195:110796.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Ru H, Lee AL, Rappazzo K, Dzierlenga MW, Radke E, Bateson TF, et al. Systematic review and meta-analysis of birth weight and perfluorohexane sulfonate exposures: examination of sample timing and study confidence. Occup Environ Med. 2024;81:266–76.

    PubMed

    Google Scholar

  • Wright JM, Lee AL, Rappazzo K, Ru H, Radke E, Bateson TF. Systematic review and meta-analysis of birth weight and PFNA exposures. Environ Res. 2023;222:115357.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Steenland K, Barry V, Savitz D. Serum perfluorooctanoic acid and birthweight: an updated meta-analysis with bias analysis. Epidemiology. 2018;29:765–76.

    PubMed

    Google Scholar

  • Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al. (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane, 2023. Available from www.training.cochrane.org/handbook.

  • Borenstein M, Hedges LV, Higgins JPT, Rothstein HR. Publication Bias. In: Borenstein M, Hedges LV, Higgins JPT, Rothstein JPT, editors. Introduction to meta-analysis. 2009. https://doi.org/10.1002/9780470743386.ch30.

  • American College of Obstetrics and Gynecology. How Your Fetus Grows During Pregnancy. https://www.acog.org/womens-health/faqs/how-your-fetus-grows-during-pregnancy. last accessed 8-5–25.

  • Gui SY, Chen YN, Wu KJ, et al. Association between exposure to per- and polyfluoroalkyl substances and birth outcomes: a systematic review and meta-analysis. Front Public Health. 2022;10:855348.

    PubMed
    PubMed Central

    Google Scholar

  • Callan AC, Rotander A, Thompson K, Heyworth J, Mueller JF, Odland JØ, et al. Maternal exposure to perfluoroalkyl acids measured in whole blood and birth outcomes in offspring. Sci Total Environ. 2016;569-570:1107–13.

    CAS

    Google Scholar

  • Cao W, Liu X, Liu X, Zhou Y, Zhang X, Tian H, et al. Perfluoroalkyl substances in umbilical cord serum and gestational and postnatal growth in a Chinese birth cohort. Environ Int. 2018;116:197–205.

    CAS
    PubMed

    Google Scholar

  • Espindola Santos AS, Meyer A, Dabkiewicz VE, Câmara VM, Asmus CIRF. Serum levels of perfluorooctanoic acid and perfluorooctane sulfonic acid in pregnant women: Maternal predictors and associations with birth outcomes in the PIPA Project. J Obstet Gynaecol Res. 2021;47:3107–18.

    CAS
    PubMed

    Google Scholar

  • Gao K, Zhuang T, Liu X, Fu J, Zhang J, Fu J, et al. Prenatal exposure to per- and polyfluoroalkyl substances (PFAS) and association between the placental transfer efficiencies and dissociation constant of serum proteins-PFAS complexes. Environ Sci Technol. 2019;53:6529–38.

    CAS
    PubMed

    Google Scholar

  • Mwapasa M, Huber S, Chakhame BM, Maluwa A, Odland ML, Röllin H, et al. Serum concentrations of selected poly- and perfluoroalkyl substances (PFAS) in pregnant women and associations with birth outcomes. a cross-sectional study from southern Malawi. Int J Environ Res Public Health. 2023;20:1689.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Shi Y, Yang L, Li J, Lai J, Wang Y, Zhao Y, et al. Occurrence of perfluoroalkyl substances in cord serum and association with growth indicators in newborns from Beijing. Chemosphere. 2017;169:396–402.

    CAS
    PubMed

    Google Scholar

  • Workman CE, Becker AB, Azad MB, Moraes TJ, Mandhane PJ, Turvey SE, et al. Associations between concentrations of perfluoroalkyl substances in human plasma and maternal, infant, and home characteristics in Winnipeg, Canada. Environ Pollut. 2019;249:758–66.

    CAS
    PubMed

    Google Scholar

  • Xu C, Yin S, Liu Y, Chen F, Zhong Z, Li F, et al. Prenatal exposure to chlorinated polyfluoroalkyl ether sulfonic acids and perfluoroalkyl acids: potential role of maternal determinants and associations with birth outcomes. J Hazard Mater. 2019;380:120867.

    CAS
    PubMed

    Google Scholar

  • Zhang B, Wei Z, Gu C, Yao Y, Xue J, Zhu H, et al. First evidence of prenatal exposure to emerging poly- and perfluoroalkyl substances associated with e-waste dismantling: chemical structure-based placental transfer and health risks. Environ Sci Technol. 2022;56:17108–18.

    CAS
    PubMed

    Google Scholar

  • Apelberg BJ, Witter FR, Herbstman JB, Calafat AM, Halden RU, Needham LL, et al. Cord serum concentrations of perfluorooctane sulfonate (PFOS) and perfluorooctanoate (PFOA) in relation to weight and size at birth. Environ Health Perspect. 2007;115:1670–6.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Cai D, Li QQ, Mohammed Z, Chou WC, Huang J, Kong M, et al. Fetal glucocorticoid mediates the association between prenatal per- and polyfluoroalkyl substance exposure and neonatal growth index: evidence from a birth cohort study. Environ Sci Technol. 2023;57:11420–9.

    CAS
    PubMed

    Google Scholar

  • Chang CJ, Barr DB, Ryan PB, Panuwet P, Smarr MM, Liu K, et al. Per- and polyfluoroalkyl substance (PFAS) exposure, maternal metabolomic perturbation, and fetal growth in African American women: a meet-in-the-middle approach. Environ Int. 2022;158:106964.

    CAS
    PubMed

    Google Scholar

  • Chen MH, Ha EH, Wen TW, Su YN, Lien GW, Chen CY, et al. Perfluorinated compounds in umbilical cord blood and adverse birth outcomes. PLoS One. 2012;7:e42474.

  • de Cock M, De Boer MR, Lamoree M, Legler J, Van De Bor M. Prenatal exposure to endocrine disrupting chemicals and birth weight-A prospective cohort study. J Environ Sci Health A Tox Hazard Subst Environ Eng. 2016;51:178–85.

    PubMed

    Google Scholar

  • Gyllenhammar I, Diderholm B, Gustafsson J, Berger U, Ridefelt P, Benskin JP, et al. Perfluoroalkyl acid levels in first-time mothers in relation to offspring weight gain and growth. Environ Int. 2018;111:191–9.

    CAS
    PubMed

    Google Scholar

  • Hamm MP, Cherry NM, Chan E, Martin JW, Burstyn I. Maternal exposure to perfluorinated acids and fetal growth. J Expo Sci Environ Epidemiol. 2010;20:589–97.

    CAS
    PubMed

    Google Scholar

  • Hjermitslev MH, Long M, Wielsøe M, Bonefeld-Jørgensen EC. Persistent organic pollutants in Greenlandic pregnant women and indices of foetal growth: the ACCEPT study. Sci Total Environ. 2020;698:134118.

    CAS
    PubMed

    Google Scholar

  • Kashino I, Sasaki S, Okada E, Matsuura H, Goudarzi H, Miyashita C, et al. Prenatal exposure to 11 perfluoroalkyl substances and fetal growth: a large-scale, prospective birth cohort study. Environ Int. 2020;136:105355.

    CAS
    PubMed

    Google Scholar

  • Kwon EJ, Shin JS, Kim BM, Shah-Kulkarni S, Park H, Kho YL, et al. Prenatal exposure to perfluorinated compounds affects birth weight through GSTM1 polymorphism. J Occup Environ Med. 2016;58:e198–e205.

    CAS
    PubMed

    Google Scholar

  • Lenters V, Portengen L, Rignell-Hydbom A, Jönsson BA, Lindh CH, Piersma AH, et al. Prenatal Phthalate, Perfluoroalkyl Acid, and Organochlorine Exposures and Term Birth Weight in Three Birth Cohorts: Multi-Pollutant Models Based on Elastic Net Regression. Environ Health Perspect. 2016;124:365–72.

    CAS
    PubMed

    Google Scholar

  • Maisonet M, Terrell ML, McGeehin MA, Christensen KY, Holmes A, Calafat AM, et al. Maternal concentrations of polyfluoroalkyl compounds during pregnancy and fetal and postnatal growth in British girls. Environ Health Perspect. 2012;120:1432–7.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Meng Q, Inoue K, Ritz B, Olsen J, Liew Z. Prenatal exposure to perfluoroalkyl substances and birth outcomes; an updated analysis from the Danish National Birth Cohort. J Environ Res Public Health. 2018;15:1832.

    Google Scholar

  • Peterson AK, Eckel SP, Habre R, Yang T, Faham D, Amin M, et al. Detected prenatal perfluorooctanoic acid (PFOA) exposure is associated with decreased fetal head biometric parameters in participants experiencing higher perceived stress during pregnancy in the MADRES cohort. Environ Adv. 2022;9:100286.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Robledo CA, Yeung E, Mendola P, Sundaram R, Maisog J, Sweeney AM, et al. Preconception maternal and paternal exposure to persistent organic pollutants and birth size: the LIFE study. Environ Health Perspect. 2015;123:88–94.

    PubMed

    Google Scholar

  • Sevelsted A, Gürdeniz G, Rago D, Pedersen CT, Lasky-Su JA, Checa A, et al. Effect of perfluoroalkyl exposure in pregnancy and infancy on intrauterine and childhood growth and anthropometry. Sub study from COPSAC2010 birth cohort. EBioMedicine. 2022;83:104236.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Siwakoti RC, Cathey A, Ferguson KK, Hao W, Cantonwine DE, Mukherjee B, et al. Prenatal per- and polyfluoroalkyl substances (PFAS) exposure in relation to preterm birth subtypes and size-for-gestational age in the LIFECODES cohort 2006-2008. Environ Res. 2023;237:116967.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Wang H, Du H, Yang J, Jiang H, O K, Xu L, et al. PFOS, PFOA, estrogen homeostasis, and birth size in Chinese infants. Chemosphere. 2019;221:349–55.

    CAS
    PubMed

    Google Scholar

  • Wang Z, Zhang J, Dai Y, Zhang L, Guo J, Xu S, et al. Mediating effect of endocrine hormones on association between per- and polyfluoroalkyl substances exposure and birth size: findings from Sheyang Mini Birth Cohort Study. Environ Res. 2023a;226:115658.

    CAS
    PubMed

    Google Scholar

  • Zheng T, Kelsey K, Zhu C, Pennell KD, Yao Q, Manz KE, et al. Adverse birth outcomes related to concentrations of per- and polyfluoroalkyl substances (PFAS) in maternal blood collected from pregnant women in 1960-1966. Environ Res. 2024;241:117010.

    CAS
    PubMed

    Google Scholar

  • Ashley-Martin J, Dodds L, Arbuckle TE, Bouchard MF, Fisher M, Morriset AS, et al. Maternal concentrations of perfluoroalkyl substances and fetal markers of metabolic function and birth weight. Am J Epidemiol. 2017;185:185–93.

    PubMed
    PubMed Central

    Google Scholar

  • Bach CC, Bech BH, Nohr EA, Olsen J, Matthiesen NB, Bonefeld-Jørgensen EC, et al. Perfluoroalkyl acids in maternal serum and indices of fetal growth: the Aarhus Birth Cohort. Environ Health Perspect. 2016;124:848–54.

    CAS
    PubMed

    Google Scholar

  • Bell EM, Yeung EH, Ma W, Kannan K, Sundaram R, Smarr MM, et al. Concentrations of endocrine disrupting chemicals in newborn blood spots and infant outcomes in the Upstate KIDS study. Environ Int. 2018;121:232–9.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Buck Louis GM, Zhai S, Smarr MM, Grewal J, Zhang C, Grantz KL, et al. Endocrine disruptors and neonatal anthropometry, NICHD Fetal Growth Studies – Singletons. Environ Int. 2018;119:515–26.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Chu C, Zhou Y, Li QQ, Bloom MS, Lin S, Yu YJ, et al. Are perfluorooctane sulfonate alternatives safer? New insights from a birth cohort study. Environ Int. 2020;135:105365.

    CAS
    PubMed

    Google Scholar

  • Darrow LA, Stein CR, Steenland K. Serum perfluorooctanoic acid and perfluorooctane sulfonate concentrations in relation to birth outcomes in the Mid-Ohio Valley, 2005-2010. Environ Health Perspect. 2013;121:1207–13.

    PubMed
    PubMed Central

    Google Scholar

  • Eick SM, Hom Thepaksorn EK, Izano MA, Cushing LJ, Wang Y, Smith SC, et al. Associations between prenatal maternal exposure to per- and polyfluoroalkyl substances (PFAS) and polybrominated diphenyl ethers (PBDEs) and birth outcomes among pregnant women in San Francisco. Environ Health. 2020;19:100.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Govarts E, Remy S, Bruckers L, Den Hond E, Sioen I, Nelen V, et al. Combined effects of prenatal exposures to environmental chemicals on birth weight. Int J Environ Res Public Health. 2016;13:495.

    PubMed
    PubMed Central

    Google Scholar

  • Lauritzen HB, Larose TL, Øien T, Sandanger TM, Odland JØ, van de Bor M, et al. Maternal serum levels of perfluoroalkyl substances and organochlorines and indices of fetal growth: a Scandinavian case-cohort study. Pediatr Res. 2017;81:33–42.

    PubMed

    Google Scholar

  • Lind DV, Priskorn L, Lassen TH, Nielsen F, Kyhl HB, Kristensen DM, et al. Prenatal exposure to perfluoroalkyl substances and anogenital distance at 3 months of age in a Danish mother-child cohort. Reprod Toxicol. 2017;68:200–6.

    CAS
    PubMed

    Google Scholar

  • Luo D, Wu W, Pan Y, Du B, Shen M, Zeng L. Associations of prenatal exposure to per- and polyfluoroalkyl substances with the neonatal birth size and hormones in the growth hormone/insulin-like growth factor axis. Environ Sci Technol. 2021;55:11859–73.

    CAS
    PubMed

    Google Scholar

  • Manzano-Salgado CB, Casas M, Lopez-Espinosa MJ, Ballester F, Iñiguez C, Martinez D, et al. Prenatal exposure to perfluoroalkyl substances and birth outcomes in a Spanish birth cohort. Environ Int. 2017;108:278–84.

    CAS
    PubMed

    Google Scholar

  • Sagiv SK, Rifas-Shiman SL, Fleisch AF, Webster TF, Calafat AM, Ye X, et al. Early-pregnancy plasma concentrations of perfluoroalkyl substances and birth outcomes in Project Viva: confounded by pregnancy hemodynamics?. Am J Epidemiol. 2018;187:793–802.

    PubMed

    Google Scholar

  • Shen C, Ding J, Xu C, Zhang L, Liu S, Tian Y. Perfluoroalkyl mixture exposure in relation to fetal growth: potential roles of maternal characteristics and associations with birth outcomes. Toxics. 2022;10:650.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Shoaff J, Papandonatos GD, Calafat AM, Chen A, Lanphear BP, Ehrlich S, et al. Prenatal exposure to perfluoroalkyl substances: infant birth weight and early life growth. Environ Epidemiol. 2018;2:e10.

    Google Scholar

  • Starling AP, Adgate JL, Hamman RF, Kechris K, Calafat AM, Ye X, et al. Perfluoroalkyl substances during pregnancy and offspring weight and adiposity at birth: examining mediation by maternal fasting glucose in the Healthy Start Study. Environ Health Perspect. 2017;125:067016.

    PubMed
    PubMed Central

    Google Scholar

  • Valvi D, Oulhote Y, Weihe P, Dalgård C, Bjerve KS, Steuerwald U, et al. Gestational diabetes and offspring birth size at elevated environmental pollutant exposures. Environ Int. 2017;107:205–15.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Wang Z, Luo J, Zhang Y, Li J, Zhang J, Tian Y, et al. High maternal glucose exacerbates the association between prenatal per- and polyfluoroalkyl substance exposure and reduced birth weight. Sci Total Environ. 2023b;858:160130.

    CAS
    PubMed

    Google Scholar

  • Whitworth KW, Haug LS, Baird DD, Becher G, Hoppin JA, Skjaerven R, et al. Perfluorinated compounds in relation to birth weight in the Norwegian Mother and Child Cohort Study. Am J Epidemiol. 2012;175:1209–16.

    PubMed
    PubMed Central

    Google Scholar

  • Wikström S, Lin PI, Lindh CH, Shu H, Bornehag CG. Maternal serum levels of perfluoroalkyl substances in early pregnancy and offspring birth weight. Pediatr Res. 2020;87:1093–9.

    PubMed

    Google Scholar

  • Xiao C, Grandjean P, Valvi D, Nielsen F, Jensen TK, Weihe P, et al. Associations of exposure to perfluoroalkyl substances with thyroid hormone concentrations and birth size. J Clin Endocrinol Metab. 2020;105:735–45.

    PubMed

    Google Scholar

  • Zhang Y, Mustieles V, Martin L, Sun Y, Hillcoat A, Fang X, et al. Maternal and paternal preconception serum concentrations of per and polyfluoroalkyl substances in relation to birth outcomes. Environ Sci Technol. 2024;58:2683–92.

    CAS
    PubMed
    PubMed Central

    Google Scholar

  • Linakis MW, Van Landingham C, Gasparini A, Longnecker MP. Re-expressing coefficients from regression models for inclusion in a meta-analysis. BMC Med Res Methodol. 2024;24:6.

    PubMed
    PubMed Central

    Google Scholar

  • Kopylev L, Dzierlenga MW 2025. The importance of considering variability in re-expression of effect estimate. BMC Medical Research Methodology. In Review.

  • Padula AM, Ning X, Bakre S, Barrett ES, Bastain T, Bennett DH, et al. Birth outcomes in relation to prenatal exposure to per- and polyfluoroalkyl substances and stress in the environmental influences on child health outcomes (ECHO) program. Environ Health Perspect. 2023;131:37006.

    CAS
    PubMed

    Google Scholar

  • Guo P, Warren JL, Deziel NC, Liew Z. Exposure range matters: considering non-linear associations in the meta-analysis of environmental pollutant exposure using examples of per- and polyfluoroalkyl substances and birth outcomes. Am J Epidemiol. 2024:kwae309. https://doi.org/10.1093/aje/kwae309.

  • Marks KJ, Cutler AJ, Jeddy Z, Northstone K, Kato K, Hartman TJ. Maternal serum concentrations of perfluoroalkyl substances and birth size in British boys. Int. J. Hyg Environ. Health 2019;222:889–95.

  • August 23, 2025 0 comments
    0 FacebookTwitterPinterestEmail
    Health

    Enzyme replacement therapy for the treatment of late onset Pompe disease: A systematic review and network meta-analysis | Orphanet Journal of Rare Diseases

    by Dr. Michael Lee – Health Editor August 22, 2025
    written by Dr. Michael Lee – Health Editor

    Search results

    Table of Contents

    • Search results
    • Study details and baseline characteristics
    • IPD from eligible trials
    • Risk of bias assessment
    • NMAs of RCT evidence
    • RCT extension studies
    • Registry studies
    • Other prospective studies
      • 6MWD results
      • Other outcomes

    After screening 4286 titles and abstracts, 237 full-texts were retrieved and screened. Thirty-eight studies (encompassing 106 unique records) were included in the review: three RCTs (LOTS[[3], PROPEL[[24]and COMET[[25]), three RCT extension studies[[26,27,28], seven Pompe disease registry studies[[29,30,31,32,33,34,35]and 25 single-group prospective studies[[2, 6, 36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58]. The process of identifying and selecting records is presented in the PRISMA flowchart (Fig. 2).

    Fig. 2

    Study details and baseline characteristics

    The LOTS RCT evaluated the safety and efficacy of alglucosidase alfa compared to placebo (plus BSC). The COMET and PROPEL RCTs assessed the safety and efficacy of avalglucosidase alfa and cipaglucosidase alfa plus miglustat, respectively, compared to alglucosidase alfa. Mean ages across the three trials ranged from 44 to 48 years (Table 2, Additional file 2). The proportion of participants using a walking aid at baseline was 43% in LOTS and 23% in PROPEL (data were not reported for COMET). LOTS and COMET recruited only ERT-naïve patients, whereas PROPEL recruited mostly ERT-experienced patients.

    Of the seven registry studies, there were three studies from Sanofi’s international Pompe Registry cohort[[29,30,31], with sample sizes ranging from 396 to 1390 patients, three studies from the French Pompe disease registry[[32,33,34](range 29 to 177 patients) and one Spanish Pompe registry study (N = 113)[[35], (Table 1, Additional file 3). The largest study was reported only as a conference abstract[[31]. The mean ages when starting ERT ranged between 45 and 56 years, except for the Spanish registry study which was of a younger cohort (mean 29 years). Follow-up durations ranged from one to 10 years.

    All other prospective studies (n = 25) included in the review were single-group studies: none compared an ERT with a specific type of best supportive care, although some studies did compare ERT patients with those not taking an ERT. Sample sizes ranged from 11 to 209 patients (Table 3, Additional file 3). Eleven studies included 30 or fewer patients and 6 studies included 100 or more patients; the number of patients included in individual analyses was often notably smaller than the number recruited e.g. some patients were not physically able to undertake an assessment of 6-minute walk distance. Two studies were reported only as conference abstracts[[41, 47]. All studies were of alglucosidase alfa, except for the NEO1/NEO-EXT study of avalglucosidase alfa[[57], and the ATB200-02 study of cipaglucosidase alfa plus miglustat[[58]. Most studies were conducted in Italy, Germany or the Netherlands. Five of the 25 studies[[39, 40, 45, 55, 59]reported results for a child cohort or subgroup (mean age ranged between 6 and 12 years), with the remaining studies being of adults (mean age range between 43 and 53 years). In one small study[[40]all patients were ERT-experienced at study entry, with patients typically having been on an ERT for around nine years. There was substantial variation across studies in the proportion of patients requiring wheelchair or respiratory support at baseline. Follow up durations ranged from 6 months to 15 years, with most patients being followed up for between 2 and 5 years.

    IPD from eligible trials

    IPD was sought from the three identified RCTs: PROPEL, LOTS and COMET. However, no IPD was provided by any of the sponsors. Amicus Therapeutics was contacted regarding sharing data from the PROPEL trial. In email correspondence, Amicus Therapeutics representatives indicated they were working on a process and platform to make these data available but failed to respond to further email contacts. Access to data from the LOTS and COMET trials was sought from the sponsor Sanofi via the data-sharing platform Vivli. Sanofi declined the request stating that they considered the proposed research not to be in the interest of patients or the patient community.

    In the absence of IPD from the sponsors of the RCTs, we digitised the mean difference plots of the outcomes (FVC % predicted and 6MWD) using the PlotDigitzer website (https://plotdigitizer.com/) to obtain estimates of the mean differences at 12/13 weeks, 24/25 weeks, 36/38 weeks, and 49/52 weeks.

    Risk of bias assessment

    Risk of bias assessment results are presented in Additional file 2, Table 1. The COMET trial results were judged to have a low overall risk of bias but the LOTS and PROPEL trial results were judged to be at high risk of bias. Both LOTS and PROPEL had high risk judgements for the ‘bias in the selection of the reported result’ domain, since both trials failed to report results for all pre-specified analyses, as noted in the respective EMA reports[[60]. , [[61]

    Another study quality issue identified was the reporting of results using only means in the published reports. Results data from regulatory documents showed skewing of the 6MWD data by outliers, with the means and medians differing substantially. The reporting of only means in the presence of outliers in a sample is not an accurate representation of the efficacy data. For example, the FDA reported that in COMET the mean change in 6MWD from baseline to week 49 for the alglucosidase arm was − 1.7 m, whereas the median was 16.0 m;[[20]the EMA reported that in LOTS the mean change in 6MWD from baseline to week 78 for the alglucosidase arm was 26.1 m, whereas the median was 15.0 m[[62].

    NMAs of RCT evidence

    Results from the primary analysis are reported on Table 1 and results of the sensitivity analyses and additional analyses are presented in Additional file 2.

    In the primary analysis of FVC % predicted at 49/52 weeks, the results indicate that all three ERTs exhibit numerical superiority over placebo (which includes BSC). However, the estimated mean differences did not reach statistical significance for any of the ERTs (Table 2). In contrast, for 6MWD there were statistically significant improvements compared to placebo for both alglucosidase alfa (by around 25 m) and avalglucosidase alfa (by around 54 m). Cipaglucosidase alfa with miglustat, while numerically superior to placebo, did not show statistically significant differences. Credible intervals for this comparison were wide, reflecting the small number of ERT-naïve patients in the PROPEL trial.

    Analysis of additional time points revealed a consistent pattern (Additional File 2 – Tables 8 and 9), with no statistically significant differences between any ERT and placebo for FVC % predicted at any time point. For each ERT versus placebo for 6MWD, statistically significant differences were observed favouring alglucosidase alfa beginning at week 12/13 and persisting through later time points. Similarly, statistically significant differences for avalglucosidase alfa were estimated from week 24/26, with sustained effects observed at subsequent time points. Cipaglucosidase alfa with miglustat showed numerical superiority across all remaining time points, but differences did not reach statistical significance.

    Intra-ERT comparisons showed a numerical difference between avalglucosidase alfa and alglucosidase alfa at 49/52 weeks for both FVC% predicted and a meaningful numerical difference in 6MWD. Sensitivity analyses conducted at other time points, including an analysis at 49/52 weeks using imputed values for the COMET trial, similarly did not demonstrate statistically significant differences for either outcome. Results of the sensitivity analysis (Additional File 2, Table 7) also show a smaller numerical difference between avalglucosidase alfa and alglucosidase alfa; mean difference 12.43 m, (95%CrI: -13.17 to 38.07) vs. 28.87 m (95% CrI: 1.74 vs. 55.66). Cipaglucosidase alfa with miglustat exhibited numerical inferiority compared to avalglucosidase alfa for both outcomes across all time points and sensitivity analyses (Additional File 2, Tables 6, 7, 8 and 9); however, the differences were not statistically significant, and credible intervals were wide. Compared to alglucosidase alfa, cipaglucosidase alfa with miglustat demonstrated numerical inferiority for both outcomes in the primary and sensitivity analysis, but the differences were small and credible intervals were wide. This pattern of numerical inferiority was consistent across all time points (except week 24/26) for 6MWD. Differences for FVC% predicted were, however, inconsistent, with weeks 12/13 and 24/26 favouring alglucosidase alfa, and the week 37/38 analysis favouring cipaglucosidase alfa with miglustat. At all-time points and for both outcomes, differences between alglucosidase alfa and cipaglucosidase alfa with miglustat were not statistically significant.

    Table 1 Relative treatment effects of FVC and 6MWD (random effect NMA), primary analysis (49/52 weeks of follow-up for all RCTs)

    The combined treatment effectiveness of all ERTs demonstrated significant numerical superiority over placebo for 6MWD at all time points (Additional File 2, Table 16). For FVC% predicted, ERTs also showed numerical superiority; however, the difference was not statistically significant using the random-effects model.

    Evidence in the ERT-experienced population was limited to a subgroup from the PROPEL trial which included participants who had received ERT for at least 2 years. Results from the PROPEL trial favoured cipaglucosidase alfa with miglustat with statistically significant differences in both 6MWD and FVC% predicted reported, mean difference: 16.8 m (95% CrI: 0.2 to 33.3) and 3.5 (95% CrI: 1.0 to 6.0) respectively. However, the reported results of this trial were judged to be at high risk of bias.

    RCT extension studies

    Each of the three RCTs had open-label extension studies. PROPEL was extended by 52 weeks[[26], LOTS by 26 weeks (and by 52 weeks for a subset of U.S. patients)[[27], and COMET by 48 weeks (reported in a published paper[[28]) and 96 weeks (reported in two conference abstracts[[63, 64]). Given that patients may potentially receive ERTs for many years, these extension studies are relatively short in terms of providing evidence of the long-term effects of ERTs. Results are reported in Table 14, and 15 of Additional file 2.

    In PROPEL, the ERT-experienced group which continued taking cipaglucosidase alfa with miglustat had small increases in % predicted 6MWD and % predicted FVC from week 52 to week 78, followed by small declines by week 104; however, no details were reported on how missing data were handled in the analyses (11 patients discontinued treatment). The LOTS cohort also showed a small decline in 6MWD and FVC % predicted from week 78 to week 104 for the group which continued taking alglucosidase alfa (data were missing for only one patient). In the COMET extension study FVC % predicted remained relatively stable, but 6MWD and hand-held dynamometry had decreased notably by week 97. In mitigation, the authors stated that some patients missed infusions due to the COVID-19 pandemic. A further difficulty when interpreting the COMET extension results is that data were missing at week 97 for 9 (6MWD), and 8 (FVC % predicted), of the 51 patients who continued taking avalglucosidase alfa and the analyses assumed that data were missing at random. This assumption does not appear reasonable for those patients who discontinued due to adverse events.

    Registry studies

    Semplicini et al.[[32]followed 158 patients for a median of around five years, finding a 1.4% annual increase in % predicted 6MWD up to 2.2 years, followed by a 2.3% decline (Table 2, Additional file 3). For muscle function outcomes, the Motor Function Measurement D2 sub-score showed a progressive 1.0% decline per year, and the D3 sub-score had a slower progressive decline (0.2% per year).

    Tard et al. reported on the effect of switching from alglucosidase alfa to avalglucosidase alfa in 29 patients, reporting stabilisation of 6MWD results after one year of avalglucosidase alfa (when compared to pre-switch one year data, which showed declines)[[34]. The reporting of 6MWD results data in Lefeuvre et al.’s study was somewhat unclear`, although the treated population experienced a decline in 6MWD. Martinez–Marin et al.’s Spanish registry study reported yearly 6MWD declines of between 5 and 9 m in subgroups treated for < 5 years, 5–10 years and > 10 years[[35].

    All studies reported FVC % predicted, mostly as a long-term outcome. Annual declines in %FVC after up to five years of ERT ranged between 0.17% and 0.9%. Declines at time points between 5 and 13 years were similar across two studies ranging between 1.0 and 1.2%[[29, 35]. Tard et al. found no statistically significant difference in %FVC in patients who switched ERT[[34]. Three studies reported mortality, with mean or median ages at death ranging between 60 and 66 years[[29, 32, 33].

    Other prospective studies

    6MWD results

    The reporting of the 18 studies with 6MWD results varied (Table 5, Additional file 3). Only three studies reported results as medians[[39, 48, 53]and only seven reported results as changes from baseline as absolute values;[[2, 36, 40, 47, 48, 51, 58]five studies reported results as changes in % predicted 6MWD[[41, 46, 55, 57, 58]. The remaining studies either reported results only graphically[[49], or reported baseline and end of follow up data but with the difference represented only as a p-value[[37,38,39, 52, 53].

    Of the studies reporting changes from baseline, two very small studies reported improvements at 6 months of 37 m[[2]and 47 m;[[47]the result was statistically significant for the former, though level of statistical significance was not reported for the latter. One study reported a statistically significant improvement at up to one year of around 44 m, although this result was also based on a small cohort (n = 20)[[36]. For later time points, a non-statistically significant improvement of 16 m at > 3 years[[36], and a statistically significant increase of 41 m at 5 years[[48]were reported. Ravaglia et al. followed a small cohort up to 15 years; although most of the data were only reported graphically, the study’s results showed significant improvement of around 55 m at one year, a return to baseline at around three years, and continued decline up to 15 years[[50].

    The studies reporting % predicted 6MWD results were generally limited by very small samples sizes or by being available only as an abstract. However, Harlaar et al., including 30 patients from the LOTS trial cohort reported initial improvements for around two years, followed by gradual decline up to 10 years[[46]. Thirteen patients had some wheelchair dependency at the end of follow-up compared to 7 patients at the start. The remaining 6MWD studies reported statistically significant improvements up to two years and of the two studies which also reported results at three years, one found a statistically significant improvement[[39]while the other did not[[52].

    Other outcomes

    The 16 studies which reported FVC % predicted results were broadly consistent across their results. These indicated little change after up to one or two years of ERT, thereafter followed by slow declines over up to 10 years of follow up (Table 5, Additional file 3). The most common muscle function or strength outcomes reported were the Medical Research Council (MRC) scale (8 studies), handheld dynamometry (HHD, 4 studies) and the quick motor function test (QMFT, 3 studies). The studies reporting MRC scores had heterogeneous results with two studies (both n > 50) showing small but statistically significant increases during the first 2–3 years of ERT[[36, 42]whereas other studies reporting results for up to three years did not find statistically significant improvements[[52, 53]. No statistically significant improvements were seen in any of the studies reporting MRC scores at later time points. Two quite large studies which reported HHD outcomes found statistically significant improvements after up to two years of ERT[[42, 48], with one also reporting a plateauing of effect at around three years[[48]. These two studies also reported QMFT, which did not improve significantly in either study at up to five years of follow up.

    One study analysed the effect of ERT on mortality by comparing ERT patients with patients not taking ERT[[44]. It found that the use of ERT was positively and statistically significantly associated with survival. Van der Meijden et al.[[54]also compared ERT users with non-ERT users in their large survey study, finding that ERT significantly reduced the risk for wheelchair use, but not the risk of needing respiratory support. Most of the six studies reporting ERT infusion-associated reactions found the occurrence rate to be around 25% (Table 5, Additional file 3).

    August 22, 2025 0 comments
    0 FacebookTwitterPinterestEmail
    Health

    Lessons for synthetic data from care.data’s past

    by Dr. Michael Lee – Health Editor August 10, 2025
    written by Dr. Michael Lee – Health Editor

    Synthetic Data Must Learn From NHS Data Fumbles

    Confidentiality, Consent, and Transparency Key to Public Trust

    Future use of synthetic health data hinges on addressing critical concerns that previously derailed NHS data initiatives, like the ill-fated care.data programme. Lessons learned highlight the absolute necessity of robust patient confidentiality, clear consent protocols, and unwavering transparency to build public confidence.

    Confidentiality: A Constant Battle

    Concerns over patient re-identification were central to opposition against care.data, a point championed by groups like medConfidential. Even with pseudo-anonymisation, the risk of linking data back to individuals persists, subjecting it to stringent UK General Data Protection Regulation laws.

    Professional bodies, including the British Medical Association (BMA) and the Royal College of General Practitioners (RCGP), echoed these anxieties, fearing a detrimental impact on the patient-doctor relationship and ultimately, patient care. NHS England’s inability to sufficiently allay public and professional fears regarding re-identification risk ultimately contributed to care.data’s downfall.

    Risk Stratification for Synthetic Data

    To navigate these challenges, a tiered approach to privacy metrics for synthetic datasets is proposed. Categorising data by risk level—low, medium, and high—will enable policymakers to implement proportionate safeguards and reassure stakeholders.

    Such risk stratification should involve national consensus from cross-functional teams, merging technical expertise with sector-specific knowledge. Low-fidelity synthetic data, posing minimal re-identification risk, could face less rigorous access protocols, facilitating broader data sharing. For instance, a pilot program offers publicly downloadable low-fidelity synthetic data derived from Hospital Episode Statistics aggregate data.

    Medium-risk datasets might necessitate enhanced security measures, such as Trusted Research Environments (TREs). Organisations unable to support TREs would be guided towards generating low-fidelity synthetic data. High-fidelity synthetic data, however, would require adherence to the same stringent access procedures as real-world data, potentially leading organisations to opt for direct real-world data acquisition instead.

    Consent: Rebuilding the Social Contract

    A significant failure of care.data was its inadequate approach to patient consent, widely perceived as a breach of patient autonomy. Proposed consent strategies, such as posters in GP practices and mailed leaflets, proved problematic.

    These methods relied on assumptions of readership and excluded individuals with literacy or language barriers. Unaddressed leaflets were often dismissed as junk mail, and households opting out of unsolicited mail were entirely missed. Furthermore, feedback indicated a lack of explicit mention of care.data by name, insufficient detail on risks, including re-identification, and unclear opt-out mechanisms.

    Public acceptance is paramount for the success of synthetic data initiatives. While legal compliance is necessary, it does not guarantee social legitimacy. As noted by **Carter et al.**, data-sharing projects depend on a ‘social contract’ built on trust and transparency.

    Patients must grasp the nature of synthetic data, its associated risks and benefits, and their rights as data subjects. Without this clear communication, synthetic data projects risk facing public backlash, mirroring care.data’s fate due to a fractured social contract. Consequently, meaningful engagement with Patient and Public Involvement and Engagement groups must be a priority for policymakers.

    Transparency: Who Holds the Data?

    A key critique leading to care.data’s demise was the lack of clarity regarding data access. Amendments to the Care Act 2014 later prohibited data release to certain commercial entities, like marketing and insurance firms.

    While research indicates public concern lessens when data access conditions include clear public benefit, care.data’s clarifications arrived too late. More recent NHS data-sharing plans, such as those involving a federated learning platform, have encountered difficulties, largely stemming from controversy over a contract awarded to the US tech company Palantir.

    To prevent similar transparency failures, synthetic data initiatives must clearly inform patients about intended users before implementation. External organisations seeking access to medium and high-fidelity synthetic data should undergo a vetting process to ensure their rationale serves the public good.

    Patients should retain the right to opt out of synthetic data generation from their personal data and decide whether commercial entities can access it. This approach respects patient autonomy and choice, addressing concerns about commercial data usage.

    In the wake of controversies surrounding NHS England’s £480 million contract with Palantir for its federated learning platform, synthetic data projects must be transparent about data creation. A designated NHS public body should ideally own and manage access to synthetic data, fostering public reassurance and avoiding the pitfalls seen in other privacy-enhancing technology (PET) initiatives.

    When outsourcing is unavoidable, potential conflicts of interest must be thoroughly assessed and disclosed to ensure partner trustworthiness in handling sensitive information. The openSAFELY federated platform, a publicly funded collaborative effort, has garnered support from the BMA, RCGP, and medConfidential, demonstrating that trust in the same technology can vary significantly depending on the platform’s management.

    In conclusion, synthetic data holds significant promise for addressing AI development challenges related to data availability and imbalance. For UK-based synthetic data initiatives to succeed, they must internalise the lessons from past endeavours like care.data by prioritizing patient confidentiality, informed consent, and organisational transparency, all with the ultimate goal of enhancing patient care.

    August 10, 2025 0 comments
    0 FacebookTwitterPinterestEmail
    Health

    Finding trials for participants: an ethnographic study of successful recruitment strategies for clinical trials | Trials

    by Dr. Michael Lee – Health Editor August 8, 2025
    written by Dr. Michael Lee – Health Editor

    UK Clinical Trials Offer Insights into Hypertension Treatment Strategies

    Ethnographic Study Reveals Complexities of Trust and Practice in Medical Research

    A comprehensive 17-month ethnographic study, focusing on building trust in clinical trials, has shed light on the intricate realities of medical research within a diverse London community. The research, part of a larger PhD, utilized an immersive approach to understand trial operations and participant experiences.

    Diverse London Setting for Landmark Study

    The study was conducted at a UK clinical trial center situated in a vibrant, multicultural area of London, reflecting the UK’s 2021 census data which reported the locale as 61.3% white, 14.1% Asian, and 10.5% Black. The personnel and participants mirrored this demographic richness, representing various nationalities and ethnicities. This center was selected for its proven track record and success in managing clinical trials, notably leading recruitment for a significant, long-term international hypertension study. This success has been linked to a substantial decline in local cardiovascular event rates, with improvements reportedly exceeding the national average by approximately 300%. The center’s research portfolio includes numerous areas of cardiovascular disease and diabetes.

    Investigating Novel Hypertension Interventions

    Three distinct trials investigating hypertension management were the focus of the observational study. These trials explored diverse therapeutic avenues: combinations of existing licensed drugs, the consumption of an organic substance in liquid form, and the implantation of a device into a major artery. The trials represented a mix of commercial and non-commercial funding, chosen to provide a broad understanding of trial practices within the same facility. One of the trials, “Snowdon,” aimed to personalize hypertension treatment by examining how “self-defined” ethnicity might influence responses to antihypertensive medications. Participants in this trial were prescribed combinations of established hypertension drugs. The study, jointly funded by a government body and a charitable organization, planned to recruit a high number of participants across more than ten UK sites.

    ‘Ben Nevis’ Trial Explores Device Implantation

    “Ben Nevis” was a commercially sponsored study by a private biotechnology firm, focusing on implanting a device into a major artery via a delivery catheter. Its primary objective was to assess the safety and effectiveness of this device in reducing blood pressure for individuals with refractory hypertension. The global trial aimed to recruit up to 200 participants at 50 international locations, with the London center targeting single-figure recruitment. This trial employed a sham-controlled design.

    ‘Scafell Pike’ Examines Natural Substance Efficacy

    The “Scafell Pike” trial investigated whether a natural, organic substance, administered in juice form, could mitigate the thickening of heart muscle (left ventricular hypertrophy) and arterial stiffness in hypertensive patients. This trial aimed for triple-digit participant recruitment at the London center. It was sponsored by a UK university and a UK hospital charity, utilizing a double-blind, randomized, placebo-controlled methodology.

    All participants in these trials received travel expense reimbursement. Additionally, “Ben Nevis” and “Scafell Pike” offered participants a nominal fee of £150 for their time. A common motivation cited by participants across all trials was the prospect of optimizing or reducing their existing medication regimen.

    Immersive Data Collection Techniques

    Data collection spanned the entire participant journey, including pre-screening, routine consultations, and post-trial follow-ups, alongside observations of the center’s reception area. Lead researcher, DJR, conducted all observations, adopting a minimally disruptive approach. For the “Snowdon” trial, observations were opportunistic, occurring on scheduled participant days. For “Ben Nevis” and “Scafell Pike,” visits were coordinated with Principal Investigators (PIs) based on appointment schedules. Staff provided consent for observation at the study’s inception. Participants were asked for consent upon arrival, with DJR introducing himself and the study before commencing note-taking in the corner of the room. His unobtrusive presence led one clinical trial practitioner to describe him as “a piece of the furniture,” indicating successful immersion.

    Ethnographic interviews, characterized by their informal and spontaneous nature during observations, were also utilized to gain deeper insights into participants’ perspectives. These often occurred when staff briefly left the room. Staff interviews were typically conducted after participant visits had concluded. Interviews with healthcare professionals and some participants were conducted. However, due to the COVID-19 pandemic, interviews with some staff, including a PI on the “Snowdon” trial and both staff members on “Ben Nevis,” were not feasible. The PI for “Scafell Pike” was interviewed pre-pandemic. Participant interviews were limited post-lockdown due to concerns about their “vulnerable” status, though researchers felt sufficient data was collected to reach “information power,” indicating data saturation and meaningful insights.

    Rigorous Thematic Analysis Underpins Findings

    The analysis of 136 pages of fieldnotes and 86 pages of interview transcripts was conducted using NVIVO 12, employing thematic analysis. This qualitative method allowed for in-depth exploration of identified themes. Initial familiarization with the data, achieved through typing fieldnotes and transcribing interviews, facilitated the spotting of patterns. Thematic analysis involved iterative coding, with codes refined through discussions between DJR and co-authors, critically examining assumptions from an outsider’s disciplinary viewpoint. The writing process itself was integral to analysis, involving continuous data review and connection-making.

    August 8, 2025 0 comments
    0 FacebookTwitterPinterestEmail
    Newer Posts
    Older Posts

    Search:

    Recent Posts

    • Olivia Nuzzi Exits Vanity Fair Amidst Contract Expiration

      December 5, 2025
    • Margot Robbie Defends Jacob Elordi Casting in Wuthering Heights

      December 5, 2025
    • Jacksonville Baseball 2026 Schedule

      December 5, 2025
    • Title: Yahoo Consent Notice: Data Usage and Cookie Policy

      December 5, 2025
    • Title: Iowa State vs. Northern Illinois: Preview & Key Stats

      December 5, 2025

    Follow Me

    Follow Me
    • Live News Feeds
    • Short Important News
    • Most Important News
    • Headlinez
    • Most Recommended Web Hosting
    • About Us
    • Accessibility statement
    • California Privacy Notice (CCPA/CPRA)
    • Contact
    • Cookie Policy
    • Copyright Notice
    • Disclaimer
    • DMCA Policy
    • EDITORIAL TEAM
    • Links
    • Privacy Policy
    • Terms & Conditions

    @2025 - All Right Reserved.

    Hosted by Byohosting – Most Recommended Web Hosting – for complains, abuse, advertising contact: contact@world-today-news.com


    Back To Top
    World Today News
    • Business
    • Entertainment
    • Health
    • News
    • Sport
    • Technology
    • World
    World Today News
    • Business
    • Entertainment
    • Health
    • News
    • Sport
    • Technology
    • World
    @2025 - All Right Reserved.

    Hosted by Byohosting – Most Recommended Web Hosting – for complains, abuse, advertising contact: contact@world-today-news.com