A set of 21 early maternal serum samples (19 first-trimester and two at 14 weeks) from pregnancies resulting in a child with Down syndrome was matched for gestation and length of storage with 63 samples from unaffected pregnancies. The concentrations of alpha-fetoprotein (AFP), unconjugated oestriol (uE3), human chorionic gonadotrophin (hCG), pregnancy-specific beta 1-glycoprotein (SP1), and placental alkaline phosphatase (PALP) were measured. The ratios of the medians for Down syndrome pregnancies compared with the medians for controls were AFP 0.71, uE3 0.67, hCG 1.43, SP1 0.79, and PALP 0.92. Although the differences between the medians for affected and unaffected pregnancies were not significant, the trends for AFP, uE3, and hCG confirm earlier findings on first-trimester samples.
BackgroundTesting for human papillomavirus (HPV) is being incorporated into the cervical screening programme, with the probable future introduction of HPV as a primary test and a possibility of HPV self‐sampling. In anticipation of this development, we sought to inform future policy and practice by identifying potential barriers to HPV self‐sampling.MethodsA cross‐sectional survey of 194 women aged 20‐64 years was conducted. Logistic regression analysis was used to identify determinants of self‐sampling intentions. A purposive subsample of 19 women who reported low self‐sampling intentions were interviewed. Interviews were framework‐analysed.ResultsMost survey participants (N=133, 69.3%) intended to HPV self‐sample. Lower intention was associated with lower self‐efficacy (OR=24.96, P≤.001), lower education (OR=6.06, P≤.05) and lower perceived importance of HPV as a cause of cervical cancer (OR=2.33, P≤.05). Interviews revealed personal and system‐related barriers. Personal barriers included a lack of knowledge about HPV self‐sampling, women's low confidence in their ability to self‐sample correctly and low confidence in the subsequent results. System‐related factors included a lack of confidence in the rationale for modifying the current cervical screening programme, and concerns about sample contamination and identity theft.ConclusionsInsights gained from this research can be used to guide further enquiry into the possibility of HPV self‐sampling and to help inform future policy and practice. Personal and system‐related barriers including low confidence in the reasons for changing current cervical screening provision need to be addressed, should HPV self‐sampling be incorporated into the cervical screening programme.
BACKGROUND The currently recommended technologies of HPLC and isoelectric focusing for newborn blood spot screening for sickle cell disease (SCD) identify both the disease and carrier states, resulting in large numbers of infants being followed up unnecessarily. Analysis of blood spot tryptic peptides performed by using tandem mass spectrometry (MS/MS) is an alternative technology to detect hemoglobin (Hb) variant disorders. METHODS We analyzed 2154 residual newborn blood spots and 675 newborn blood spots from infants with Hb variants by using MS/MS after trypsin digestion. Screening cutoffs were developed by using the ratio between the variant peptide–to–wild-type peptide abundance for HbS, C, DPunjab, OArab, Lepore, and E peptides. A postanalytical data analysis protocol was developed using these cutoffs to detect only the disease states of SCD and not to identify carrier states. A parallel study of 13 249 newborn blood spots from a high-prevalence SCD area were analyzed by both MS/MS and HPLC. RESULTS Screening cutoffs developed distinguished the infants with the disease states of SCD, infants who were carriers of SCD, and infants with normal Hb. In the parallel study no false-negative results were identified, and all clinically relevant cases were correctly identified using the MS/MS protocol. Unblinding the data revealed a total of 328 carrier infants that were successfully excluded by the protocol. CONCLUSIONS The screening protocol developed correctly identified infants with the disease states of SCD. Furthermore, large numbers of sickle cell carrier infants were successfully not identified, thereby avoiding unnecessary follow-up testing and referral for genetic counseling.
The distribution of blood spot TSH data from neonates in Wales has revealed no evidence to support the hypothesis that the population is iodine deficient. However, given that mild iodine deficiency has been reported in a cohort that will be childbearing in the next decade, we recommend that the distribution of neonatal blood spot TSH concentrations is monitored by the UK newborn screening programmes to identify any emerging trends in iodine status. Further studies to correlate maternal urinary iodine and newborn blood spot TSH are required to clarify the TSH cut-off points associated with mild iodine deficiency relevant to the time of blood spot sampling in the UK.
Background Most post-colonoscopy interval colorectal cancers are proximal; serrated polyps are often precursors to these cancers and are considered difficult to detect. We assessed the safety, feasibility, and economic effect of chromocolonoscopy on detection of proximal serrated neoplasia. Methods We did an open-label, multicentre, randomised, controlled non-inferiority trial including patients from Bowel Screening Wales centres. Participants who tested positive for faecal occult blood and who were eligible for and considered fit to have colonoscopy (patients with known cases of polyposis syndromes, Lynch syndrome, and chronic inflammatory disease were excluded) were randomly assigned (1:1; with the use of minimisation, stratified by centre with an 80:20 random element) to either standard white light colonoscopy (standard group) or chromocolonoscopy (indigo carmine dye [0•2%]; chromocolonoscopy group) using a secure, internet-based, computerised, randomisation system that used centralised, dynamic allocation. Participants were followed up for 1 year and data from index colonoscopies and associated clearance procedures were analysed. All proximal polyps were reviewed by an expert pathologist panel. The main outcome on which power was based was time taken to perform the colonoscopy procedure, defined as from the time when the scope was inserted to withdrawal from the anus, assessed in the per-protocol population. The non-inferiority margin was 15 min. This trial is complete and is registered with ClinicalTrials.gov, number NCT01972451.
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