Pilot Screening Program Research Articles

Molecular Heterogeneity of Thalassemia among Pregnant Laotian Women

Background and Aims: A pilot screening program for thalassemia was initiated in the Lao People's Democratic Republic. This study aimed to describe the genotype diversity and hematologic features of thalassemia among the participating pregnant women. Methods: Blood samples of 411 pregnant Laotian women were collected. Hemoglobin (Hb) profiles were determined using a capillary zone electrophoresis system. Mutations of α- and β-globin genes were investigated using a polymerase chain reaction and related techniques. Results: As many as 26 different thalassemia genotypes including non-transfusion-dependent thalassemia, i.e. Hb E-β-thalassemia, Hb H, and EA Bart's diseases, were identified. A variety of phenotypic expressions of hematologic features and Hb profiles were observed, including an unusual phenotype of Hb E-β⁰ thalassemia with 89.1% Hb E, 1.6% Hb F, and 9.3% Hb A₂. Conclusions: The remarkable genotype-phenotype diversity indicates a need for careful laboratory interpretation in order to provide appropriate genetic counseling and care to the Laotian population.

HPV prevalence and risk of pre-cancer and cancer in regular immigrants in Italy: results from HPV DNA test-based screening pilot programs.

ᅟImmigrants from low- and medium-income countries have a higher risk of cervical cancer due both to barriers in access to screening and to higher human papillomavirus (HPV) prevalence.In the near future many screening programmes in industrialised countries will replace Pap test with HPV as primary test. In order to plan future interventions, it is essential to understand how the HPV screening performs in immigrant women.MethodsWe conducted a survey on the main performance indicators from some of the HPV DNA-based pilot programmes in Italy, comparing regular immigrant women, identified as women resident in Italy who were born abroad, with women who were born in Italy. All the programmes applied the same protocol, with HPV as stand-alone test starting for women of 25 or 35 to 64 years of age. Cytology triage is performed for positive women; those ASC-US or more severe are referred directly to colposcopy; negative women are referred to repeat HPV after one year.ResultsOverall, 162,829 women were invited, of whom 22,814 were born abroad. Participation was higher for Italy-born than born abroad (52.2% vs. 43.6%), particularly for women over 45 years. HPV positivity rate was higher in immigrants: 7.8% vs. 6.1%, age-adjusted Relative Risk (age-adj RR) 1.18, 95% confidence interval (95% CI) 1.13-1.22. The proportion of women with positive cytology triage was similar in the two groups (42%). Cervical Intraepithelial Neoplasia (CIN) grade 2 or more severe detection rate was higher for born abroad (age-adj RR 1.65, 95% CI 1.45-1.89). The difference was stronger when considering only CIN3 or more severe (age-adj RR 2.29, 95% CI 1.90-2.75). Both HPV positivity and CIN2 or more severe detection rate had a different age curve in born abroad compared with Italy-born: in the former, the risk was almost flat, while in the latter it declined rapidly with age.ConclusionCompliance with HPV screening is lower for migrant women, who are affected by higher HPV positivity and CIN3 cancer detection rates.

Pilot program of newborn screening for sickle cell disease in angola- Angola Sickle Cell Initiative (ASCI)

Pilot program of newborn screening for sickle cell disease in angola- Angola Sickle Cell Initiative (ASCI)

Papshop: Not a ‘melon’choly Pap smear workshop!

As Head of Undergraduate Education in the Department of Obstetrics and Gynaecology at the University of Cape Town, South Africa, I have a particular interest in the competencies needed to perform primary care gynaecological procedures, one of which is the Pap smear. I was approached by a group of keen volunteer students to assist with Pap smear training to roll out a pilot screening programme at student-run after-hours clinics in Cape Town and at volunteer rural health promotion clinics. This article describes a novel approach to teaching the Pap smear technique, using fruit and toilet rolls, which can easily be replicated in resource-constrained areas. Students branded the workshops as ‘Papshops’, and the name has stuck. Increasing numbers of students are now taught by peers already trained in prior Papshops, thereby expanding the teaching workforce. To date, during 2013 - 2014, Papshop students have performed almost 300 Pap smears for eligible women in under-resourced areas.

Systematic review and meta-analysis to estimate the birth prevalence of five inherited metabolic diseases.

Many newborn screening programmes now use tandem mass spectrometry in order to screen for a variety of diseases. However, countries have embraced this technology with a differing pace of change and for different conditions. This has been facilitated by the ability of this diagnostic method to limit analysis to specific metabolites of interest, enabling targeted screening for particular conditions. MS/MS was introduced in 2009 in England to implement newborn bloodspot screening for medium chain acyl-CoA dehydrogenase deficiency (MCADD) raising the possibility of screening for other inherited metabolic disorders. Recently, a pilot screening programme was conducted in order to evaluate the health and economic consequences of screening for five additional inherited metabolic disorders in England. As part of this study we conducted a systematic review and meta-analysis to estimate the birth prevalence of these conditions: maple syrup urine disease, homocystinuria (pyridoxine unresponsive), glutaric aciduria type I, isovaleric acidaemia and long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency including trifunctional protein deficiency. We identified a total of 99 studies that were able to provide information on the prevalence of one or more of the disorders. The vast majority of studies were of screening programmes with some reporting on clinically detected cases.

The accuracy of polyp assessment during colonoscopy in FIT-screening is not acceptable on a routine basis.

Background: During colonoscopy, correct assessment of polyps is important. Recognition of early carcinomas is needed for tailor-made treatment and avoidance of unnecessary complications. Moreover, accurate diagnosis of diminutive lesions could result in a safe resect and discard strategy. We assessed the accuracy of polyp assessment by general endoscopists without specific training or experience in image-enhanced endoscopy during routine colonoscopies within a fecal immunochemical test (FIT)-based screening program. Methods: Data were collected in the third round of a FIT-based colorectal cancer screening pilot program. Patients diagnosed as FIT-positive (318) underwent colonoscopy using Olympus (160 and 180 series) endoscopes without magnification or routine use of (virtual) chromoendoscopy. Endoscopists received no special training. They made an on-site evaluation and classified detected polyps as hyperplastic, adenoma, carcinoma. Samples of resected lesions were sent for histopathology. Sensitivity and specificity were calculated. We differentiated for fellows and consultants. Results: In the 318 patients with a positive FIT-screening result, 683 lesions were detected; 564 lesions were included in the analyses. The pathologist classified these lesions as 141 hyperplastic polyps, 349 adenomas, 16 carcinomas, and 58 other. Sensitivity for diagnosis of adenomas was 88 % (95 %CI 84 – 91); specificity 49 % (95 %CI 42 – 55). Of the 16 colorectal carcinomas, endoscopists diagnosed four incorrectly (sensitivity 75 % [95 %CI 44 – 89]; specificity 99 % [95 %CI 98 – 100]), including three stage I cancers and one stage III cancer. There were no differences in accuracy of diagnosis that related to different sizes of lesions or the experience of the endoscopist. Conclusion: In a routine FIT-based screening setting and without specific training or routine use of (digital) chromoendoscopy, endoscopic prediction of the histopathology of colonic lesions is inaccurate when the procedure is performed by general endoscopists.

Glycated Hemoglobin in 14,850 Adolescent Blood Donors: A Pilot Screening Program

Substantial attention has been paid to the global epidemic of diabetes among adults, but much less data are available for adolescents. Given the recent endorsement by the American Diabetes Association of glycated hemoglobin (HbA1c) for diabetes screening (1), a pilot HbA1c screening program was implemented in adolescent blood donors by Carter BloodCare, the largest independent blood program in Texas. HbA1c was measured in 14,850 donors 16–19 years old during school blood drives conducted between 1 September 2011 and 30 April 2012. All donors gave informed consent. The main study measures were the prevalence of HbA1c levels in the prediabetes range (5.7–6.4%; 39–46 mmol/mol) and in the diabetes range (≥6.5%; ≥48 mmol/mol), with further stratification by sex, race/ethnicity, and sociodemographic characteristics. The cohort included 48.7% girls, 54.7% whites, 3.5% blacks, 24.6% Hispanics, 2.3% Asians, and 15% participants of other/unknown race/ethnicity. Table 1 presents cohort characteristics stratified by HbA1c category. The HbA1c level was above the diabetes threshold in 94 donors (0.6%), and in the prediabetes range in 1,479 donors (10%). View this table: Table 1 Sociodemographic characteristics and selected cardiovascular …

Human Papillomavirus Types Distribution in Organised Cervical Cancer Screening in France

BackgroundKnowledge of prevalence rates and distribution of human papillomavirus (HPV) genotypes prior high HPV vaccine coverage is necessary to assess its expected impact on HPV ecology and on cervical lesions and cancers.MethodsResidual specimens of cervical cytology (N = 6,538) were obtained from 16 sites participating in organised cervical cancer screening pilot programs throughout France, anonymised and tested for HPV DNA using the PapilloCheck® genotyping test. Samples were stratified according to age of women and cytological grades.ResultsThe age-standardised prevalence rates of HPV 16 and/or 18 (with or without other high-risk types) was 47.2% (95% Confidence Interval, CI: 42.4–52.1) in high-grade squamous intraepithelial lesions (HSILs), 20.2% in low-grade SIL (95% CI: 16.7–23.7) and 3.9% (95% CI: 2.8–5.1) in normal cytology. Overall HR HPV were detected in 13.7% (95%I CI: 11.7–15.6) of normal cytology. In women below 30 years of age, 64% of HSILs were associated with HPV16 and/or 18. In our study population, HPV16 was the most commonly detected type in all cervical grades with prevalence rates ranking from 3.0% in normal cytology to 50.9% in HSILs. HPV16 was also detected in 54% (27/50) of invasive cervical cancers including 5 adenocarcinomas.ConclusionHPV16 was strongly associated with cervical precancer and cancer. The high prevalence rates of HPV16/18 infection among women below 30 years of age with HSILs suggests that the impact of vaccination would be primarily observed among young women.

Evaluation of a Seven State Criminal History Screening Pilot Program for Long-Term Care Workers

This article summarizes results from an evaluation of a federally sponsored criminal history screening (CHS) pilot program to improve screening for workers in long-term care settings. The evaluation addressed eight key issues specified through enabling legislation, including efficiency, costs, and outcomes of screening procedures. Of the 204,339 completed screenings, 3.7% were disqualified due to criminal history, and 18.8% were withdrawn prior to completion for reasons that may include relevant criminal history. Lessons learned from the pilot program experiences may inform a new national background check demonstration program.

Study Protocol for the Most Effective Recall Method in a Cervical Cancer Screening Program in Klang, Malaysia

Cervical cancer is the second most common cancer among Malaysian women with an ASR of 17.9 and a mortality rate of 5.6 per 100,000 population in 2008 (GLOBOCAN, 2008). The 5 year prevalence was estimated to be 14.5 per 100,000 population. As the second most common cancer affecting productive females, cervical cancer imposes an impact to the socioeconomic aspect of the country. However, the poor uptake of cervical cancer screening is a major problem in detecting early pre-cancerous lesions and thus, delay in initiating treatment for cervical cancer. Realizing the urgency to increase the uptake of PAP smear, besides enhancing the promotion of PAP smear screening for women above 35 years old, the call-recall system for pap smear screening had been piloted in one of the suburban districts which aimed to improve regular participation of women for cervical and breast cancer screening. This is of public health importance as identifying the best feasible option to increase patient's respond to participate in the screening program effectively in our setting will be helpful in implementing an organized regular population based screening program tailored to our setting. The pilot program of cervical cancer screening in Klang was an opportunity to assess different options in recalling patients for a repeat pap smear to increase their participation and adherence to the program. This was a population based randomized control trial. Women aged 20-65 years in the population that matched the inclusion and exclusion criteria were re-called for a repeat smear. There are four different intervention groups; letter, registered letters, short messages services (SMS) and phone calls where 250 subjects were recruited into each group. Samples were generated randomly from the same population in Klang into four different groups. The first group received a recall letter for a repeat smear similar to the one that has been given during the first invitation. The intervention groups were either be given a registered letter, an SMS or a phone call to re-call them. The socio-demographic data of the patients who came for uptake were collected for further analysis. All the groups were followed up after 8 weeks to assess their compliance to the recall. The study will provide recommendations about the most effective methods for recall in a population based pap smear screening program on two outcomes: i) patients response; ii) uptake for repeat pap smear.

Jeddah Breast Cancer Pilot Screening Program: The First Program in the Western Region of the Kingdom of Saudi Arabia

Jeddah Breast Cancer Pilot Screening Program: The First Program in the Western Region of the Kingdom of Saudi Arabia

A pilot newborn screening program for Mucopolysaccharidosis type I in Taiwan

BackgroundMucopolysaccharidosis type I (MPS I) is a genetic disease caused by the deficiency of α-L-iduronidase (IDUA) activity. MPS I is classified into three clinical phenotypes called Hurler, Scheie, and Hurler-Scheie syndromes according to their clinical severity. Treatments for MPS I are available. Better outcomes are associated with early treatment, which suggests a need for newborn screening for MPS I. The goal of this study was to determine whether measuring IDUA activity in dried blood on filter paper was effective in newborn screening for MPS I.MethodsWe conducted a newborn screening pilot program for MPS I from October 01, 2008 to April 30, 2013. Screening involved measuring IDUA activity in dried blood spots from 35,285 newborns using a fluorometric assay.ResultsOf the 35,285 newborns screened, 19 did not pass the tests and had been noticed for a recall examination. After completing further recheck process, 3 were recalled again for leukocyte IDUA enzyme activity testing. Two of the three had deficient leukocyte IDUA activity. Molecular DNA analyses confirmed the diagnosis of MPS I in these two newborns.ConclusionsIt is feasible to use the IDUA enzyme assay for newborn screening. The incidence of MPS I in Taiwan estimated from this study is about 1/17,643.

Individual responsibility, solidarity and differentiation in healthcare

ObjectivesAccess to healthcare in most western societies is based on equality. Rapidly rising costs have fuelled debates about differentiation in access to healthcare. We assessed the public's perceptions and attitudes...

An analysis of the duplicate testing strategy of an Irish immunochemical faecal occult blood test colorectal cancer screening programme

This study examined the relevance of using a two-sample quantitative immunochemical faecal occult blood test (FIT) at a high cut-off stringency by the first population-based colorectal cancer (CRC) pilot screening programme in Ireland. Approximately 10,000 individuals between the ages of 50 and 74 years were invited to perform two consecutive FITs. These were analysed in tandem using the OC Sensor and participants with at least one positive result with a haemoglobin cut-off for positivity at 100 ng/ml were offered colonoscopy. A total of 5023 (52%) [2177 (43%) male, 2846 (57%) female] individuals with a median age of 64 years participated. At least one positive FIT was detected from 514 (10%) individuals. From the 419 (82%) patients who proceeded to colonoscopy 17 (4%) had CRC and 132 (33%) had an advanced adenoma. The detection rate for these screen-relevant lesions was 3% (95% CI 2.5-3.5) and the FIT-positive colonoscopy detection rate was 36% (95% CI 31-40). The number needed to undergo colonoscopy to find an advanced lesion was 2.8. The two-test system detected four (23.5%) additional patients with CRC and 37 (28%) with an advanced adenoma compared with a single test. The CRC miss rate estimated for a single test (23.5%) was unacceptably high when the goal was to maximize the discovery of advanced lesions in the initial screening round. We conclude that the two-test protocol at a high cut-off threshold is suitable for optimizing FIT screening in Ireland.

Implementation of Critical Congenital Heart Disease Screening in Minnesota

To assess the level of preparedness and resources needed in Minnesota for the implementation of newborn screening for critical congenital heart diseases (CCHDs). A cross sectional survey of all birth centers in Minnesota was performed to assess the capacity to deliver care essential for the CCHD screening program. Compliance with the screening algorithm, nursing workload, and cost were assessed by using a pilot program implemented in 6 normal newborn nurseries. Ninety-one of 99 eligible centers participated in the survey and 90 reported the ability to screen newborns in accordance with recommendations. Only 22 centers, with 63% of births, had access to echocardiography and routinely stocked prostaglandins for neonatal use. Our pilot study screened 7549 newborns with 6 failed screens and 1 CCHD diagnosis. Two of the failed screens were due to misinterpretation of the algorithm, 1 failed screen was not reported, and 4 failed screens were not recognized. Repeated screens were required for 115 newborns, with 29% of retesting due to misinterpretation of the algorithm. The mean nursing time required was 5.5 minutes, and the cost was $5.10 per screen. In Minnesota, two-thirds of newborns are born in centers with resources for initial diagnosis and management of CCHD. Implementation of a pilot screening program demonstrated minimal increase in nursing workload, but identified problems with interpretation of the algorithm and data reporting. This pilot project suggests the need for simplification of the algorithm, additional training of health care providers, and development of a centralized reporting mechanism.

Colorectal neoplasia in long‐standing ulcerative colitis – a prospective study from a low‐prevalence area

Despite increasing recognition of ulcerative colitis (UC) in Asia in recent decades, reports on the occurrence of colorectal neoplasia (CRN) in UC are scarce and surveillance for this complication is not routinely practised in this region. We aimed to assess the outcome of a newly initiated pilot screening programme for screening CRN among UC patients in India. In this prospective study from an academic hospital setting, patients with UC at high risk of CRN were offered screening by magnifying chromocolonoscopy and the frequency of neoplastic lesions was assessed. Twenty-nine (70.7%) of 41 eligible patients [a median age of 46 (interquartile range 36-54.5) years; 17 (58.6%) men] enrolled for surveillance; 41 colonoscopies were undertaken over 42 months. The median disease duration was 10 (interquartile range 7.5-14.5) years. Sixteen (55.1%) had extensive colitis. On initial screening, low-grade dysplasia (LGD) was seen in five (17.2%) and high-grade dysplasia (HGD) in three (10.3%). Of these three, one accepted proctocolectomy immediately, one underwent surgery for adenocarcinoma and one refused surgery. Twelve follow-up colonoscopies in nine patients revealed three new LGD. High-grade dysplasia and subsequent adenocarcinoma can be detected with careful follow-up in Indian patients with long-standing UC but acceptance of surveillance and subsequent therapy are suboptimal. We found evidence that screening and surveillance programmes are useful for detecting neoplasias in UC, and need to be customized for this region.

The National Health Service Bowel Cancer Screening Program: the early years

The National Health Service Bowel Cancer Screening Program (NHS BCSP) was developed to improve outcomes from colorectal cancer, the third most frequent cancer and the second highest cause of cancer deaths in the UK. Screening pilot programs were developed after previous trials demonstrated a reduction in mortality with the use of fecal occult blood population screening. A successful pilot period led to the roll out of national biennial screening for all 60–69 year olds in 2006, and extended to 60–74 year olds in 2010. To the end of 2012, there have been over 16 million invitations to screening, with uptake of 55.35%. FOBt positivity was 2.08%. Almost 15,000 cancers have been identified; screen-detected cancers have been shown to be at an earlier stage than non-screen-detected, with 35% Dukes’ stage A. The BCSP provides high quality colonoscopy with low adverse events rates. It is also a rich data source for research.

Patient and health-care impact of a pilot rheumatic heart disease screening program.

The aim of this study was to assess the impact of a pilot screening program for rheumatic heart disease (RHD) on patient quality of life (QOL) and health services. A QOL questionnaire (CHQ-PF28) was used to assess the impact of RHD screening on children with a potentially abnormal screening echocardiogram and matched normal controls. The health service response to a potentially abnormal screening echocardiogram and the impact of the screening program on health services was evaluated using medical record review, carer interviews and surveys of health-care providers. QOL was assessed in 68 children. Potentially abnormal screening echocardiograms were associated with poorer QOL in the General Health Perception (P < 0.05) and Parental Impact - Emotional (P < 0.05) domains. Health services contacted 82% of children with potentially abnormal echocardiograms, and clinical review occurred in 56%. A potentially abnormal echocardiogram was associated with a change in management in 6% (2/34) of children. When surveyed, 49% of health providers were aware of the RHD screening program, 29% had seen children referred with screening abnormalities and 85% of these providers stated this had an impact on local health-care delivery. This pilot RHD screening program was associated with poorer child and carer QOL for those with potentially abnormal results, greater health provider workload and suboptimal clinical follow-up. The adoption of screening for RHD in high-risk populations should be approached cautiously. Further research is required to facilitate and validate improved echocardiographic diagnostic criteria for RHD and the systematic assessment of the benefits and adverse effects of such screening.

Résultats d’un essai pilote de dépistage de cancer du sein par mammographie dans la région de Sfax, Tunisie

Evaluation of three rounds of mammography screening pilot programme operated between 2004and 2010in Sfax by the founders of Dar El Amal association. A biennial screening was offered to women aged over 45years and residing in five delegations of Sfax. Two radiologists independently interpret the mammograms. Twelve thousand six hundred and fifty-seven mammographies were performed. The rate of participation was 17.35%. Women under 50years had the higher rate of participation (34.7%). Some 17.2%/8% (prevalent/incident round) of participants were recalled for further assessment. The chirurgical biopsy rate was 2.1% in prevalence and 1.34% in incidence. The predictive positive value (PPV) of biopsy was 26.5% and 47.14% in the prevalent and incident rounds, respectively. The cancer detection rate amounted to 5.6‰ in prevalent round and to 6.3‰ in incident round. Twenty-five percent of invasive detected cancers were less or equal to 10mm in size and 65.5% were node-negative. The rate of interval cancer was 0.78‰. The performance of screening in this study was undermined by the relative importance of women younger than 50years. The cost of one test was 26,200TD and the cost of one cancer case screening was 6142TD. This study identified the benefits and limitations of this pilot programme to inform policy makers on the importance and feasibility of an organized mammography screening of breast cancer in Tunisia in a context of a generalization.

Assessing knowledge and attitudes towards screening among users of Faecal Immunochemical Test (FIT)

Informed decision making is recognized as important in screening. Invitees should be provided with relevant information, enabling them to make an informed decision. This may be more difficult in ethnic minority and low socio-economic status groups. We aimed to assess the proportion of informed decisions to participate in a faecal immunochemical test (FIT)-based colorectal cancer (CRC) screening pilot and to explore differences in knowledge and attitude across various subgroups. Asymptomatic persons aged 50-74 were invited to a second round of a Dutch FIT-based pilot screening programme for CRC. An information leaflet containing all information relevant to enable informed decision making accompanied the invitation. Informed choice was assessed by a mailed questionnaire. Knowledge was elicited through 18 items and attitude towards screening through four items. Main outcome measure was the proportion of informed decision makers among participants. Differences between subgroups were evaluated using logistic regression. Of 5367 screening participants, 2774 (52%) completed the questionnaire. Knowledge was adequate in 2554 (92%); 2736 (99%) showed a positive attitude towards screening. A total of 2525 persons had made an informed choice (91%); male gender, low education level, non-Dutch ethnicity and not speaking Dutch at home were negatively associated with having adequate knowledge in multivariable analysis. In FIT-based screening for CRC, the majority of responders made an informed decision to participate. However, we did not succeed in equally providing all population subgroups with sufficient information. Future initiatives should be aimed at reaching these groups to further enable informed decision making.