Quality Assurance In Screening Research Articles

New Quality Assurance of Mammographic Breast Cancer Screening with Special Reference to the Cause of Harms in Image Diagnosis

New Quality Assurance of Mammographic Breast Cancer Screening with Special Reference to the Cause of Harms in Image Diagnosis

Ethical and Regulatory Issues with Residual Newborn Screening Dried Bloodspots

After newborn screening is completed, most states retain leftover dried bloodspots. These dried bloodspots are stored for varying lengths of time among different state newborn screening programs. Dried bloodspots are a unique and valuable resource for the development of new newborn screening tests, quality assurance and biomedical research. Recent changes to the 2014 Newborn Screening Reauthorization Saves Lives Act require explicit parental consent for the retention and use of dried bloodspots in federally funded research. This has raised several ethical and regulatory issues and highlighted the challenges of respecting individual autonomy and public health goals. This article provides an overview of these issues and discusses methods for obtaining parental consent. These issues may be applicable to consent for the storage and use of biospecimens among other settings according to proposed changes to the Common Rule.

Influence of Hematocrit and Total-Spot Volume on Performance Characteristics of Dried Blood Spots for Newborn Screening.

Dried blood spots (DBS) have been used in newborn screening (NBS) tests for over 50 years. The Newborn Screening Quality Assurance Program (NSQAP) at the Centers for Disease Control and Prevention (CDC) conducted studies to assess the individual impacts of hematocrit and total-spot volume on characteristics of DBS samples. Per-punch serum volumes decreased 27%, RBC volumes more than doubled, absorption times increased over 300%, and spot diameters decreased marginally between the hematocrits of 40% to 65%. Per-punch serum and RBC volumes decreased logarithmically with lowering total-spot volumes. Patient hematocrit is an uncontrollable variable and inevitably affects the resulting punch from a DBS sample. It may be possible, though, to identify samples that fall outside of an acceptable range by noting certain physical characteristics of the DBS.

Quality assurance in diabetic retinal screening in South Africa.

Diabetic retinopathy (DR) is an important biomarker for microvascular disease and blindness. Digital fundus photography is a cost-effective way of screening for DR. Access to DR screening is difficult for many South Africans with diabetes. To perform external quality assurance (EQA) on graders registered in the Ophthalmological Society of South Africa DR screening programme. Graders registered on the South African (SA) Diabetic Register website were invited to participate in the study. The Scottish EQA software system was used to enable on-line grading of 100 retinal photographs. Expert National Health Service graders provided the consensus expert grading for the image set. Two hundred and sixty-one participants completed the EQA process, including nine ophthalmologists, 243 optometrists, and nine other graders. A wide range of outcomes were demonstrated, with a mean sensitivity of 0.905 (range 0.286 - 1.000) and mean specificity of 0.507 (0.000 - 0.935). The mean diagnostic odds ratio was calculated to be 12.3 (range 0.147 - 148.2). This is the first quality assurance study conducted with SA healthcare professionals. The outcomes are of interest to all stakeholders dealing with the diabetes epidemic. The disparity in grader performance indicates room for improvement. The results demonstrate a high referral rate to ophthalmology, suggesting that on average graders are performing safely, but with a high number of inappropriate referrals.

Impact of unilateral vocal fold mobility impairment on laryngopulmonary physiology.

To examine the impact of unilateral vocal fold mobility impairment (UVFMI) on airway physiology. Cross-sectional observational study. There were 21 patients with UVFMI and 53 controls. All patients and patient controls underwent a maximum-effort flow-volume loop examination. Forced expiratory flow in one second (FEV1 ), forced expiratory volume (FVC), peak inspiratory flow rate and peak expiratory flow rate (PIFR and PEFR, respectively) and area under the inspiratory and expiratory flow-volume loops (AUCI nspiratory and AUCE xpiratory, respectively) were measured. The ratio of PEFR to PIFR and AUCE xpiratory to AUCI nspiratory was derived. There were 48 males and 26 females. Mean age at measurement was 39 ± 11 years. Patients and controls were matched for age, sex, height and weight. None of the expiratory variables were significantly different between the groups. PIFR was significantly lower in UVFMI patients compared with controls (3.4 ± 1.2 versus 5.3 ± 1.8; P < 0.0001), as was AUCI nspiratory (11.5 ± 6.3 versus 17.5 ± 8.5; P = 0.0002). PEFR/PIFR provided the best differentiation between patients with UVFMI and controls with an area under the Receiver Operating Characteristic (ROC) curve of 0.96 and at a threshold of 1.9, and PEFR/PIFR had sensitivity and specificity of 95.2% and 90.6%, respectively. Flow-volume loops are a non-invasive method of studying vocal abduction and could compliment voice assessment and laryngoscopy in UVFMI. With further research, they could provide an outcome measure for laryngeal rehabilitative procedures, and a shared physiological language for screening and surgical quality assurance.

Quality assurance in ultrasound screening for hepatocellular carcinoma using a standardized phantom and standard clinical images: a 3-year national investigation in Korea.

The purpose of this study was to investigate the quality of ultrasound (US) imaging for hepatocellular carcinoma screening. The investigation was performed at all medical institutes participating in the National Cancer Screening Program in Korea. For assessment of personnel, we inquired who was performing the US screenings. For phantom image evaluation, the dead zone, vertical and horizontal measurements, axial and lateral resolution, sensitivity, and gray scale/dynamic range were evaluated. For clinical image evaluation, US images of patients were evaluated in terms of the standard images, technical information, overall image quality, appropriateness of depth, foci, annotations, and the presence of any artifacts. Failure rates for phantom and clinical image evaluations at general hospitals, smaller hospitals, and private clinics were 20.9%, 24.5%, 24.1% and 5.5%, and 14.8% and 9.5%, respectively. No statistically significant difference was observed in the failure rates for the phantom images among groups of different years of manufacture. For the clinical image evaluation, the results of radiologists were significantly better than those of other professional groups (P = .0001 and .0004 versus nonradiology physicians and nonphysicians, respectively). The failure rate was also higher when the storage format was analog versus digital (P < .001). Approximately 20% of US scanners failed the phantom image evaluation. The year of scanner manufacture was not significantly associated with the results of the phantom image evaluation. The quality of the clinical images obtained by radiologists was the best.

PWE-019 An Evaluation Of Quantitative Faecal Immunochemical Tests For Haemoglobin

IntroductionThe NHS Bowel Cancer Screening Programme (BCSP) in England provides biennial screening using a guaiac-based faecal occult blood test (gFOBT) for people aged 60–74 years. The European guidelines1 recommend use...

Tests and investigations for colorectal cancer screening

Worldwide, colorectal (CRC) is the third most common form of cancer, after lung and breast cancer, and the fourth most common cause of cancer death, although in developed countries CRC incidence is higher and it accounts for an even higher proportion of cancer deaths. Successful treatment of early-stage CRC confers substantial survival advantage, and there is now overwhelming evidence that screening average-risk individuals for CRC reduces the incidence and disease-specific mortality. In spite of considerable research for new biomarkers for CRC, the detection of blood in faeces remains the most effective screening tool. The best evidence to date for population-based CRC screening comes from randomised-controlled trials that used a guaiac-based faecal occult blood test (gFOBt) as the first-line screening modality, whereby test-positive individuals are referred for follow-up investigations, usually colonoscopy. A major innovation in the last ten years or so has been the development of other more analytically sensitive and specific screening techniques for blood in faeces. The faecal immunochemical test for haemoglobin (FIT) confers substantial benefits over gFOBt in terms of analytical sensitivity, specificity and practicality and FIT are now recommended for CRC screening by the European guidelines for quality assurance in colorectal cancer screening and diagnosis. The challenge internationally is to develop high quality CRC screening programmes for which uptake is high. This is especially important for developing countries witnessing an increase in the incidence of CRC as populations adopt more westernised lifestyles.This review describes the tests available for CRC screening and how they are being used worldwide. The reader will gain an understanding of developments in CRC screening and issues that arise in choosing the most appropriate screening test (or tests) for organised population-based screening internationally and optimising the performance of the chosen test (or tests). Whilst a wide range of literature has been cited, this is not a systematic review. The authors provide FOBT CRC screening for a population of 14.6 million in the south of England and the senior author (SPH) was the lead author of the European guidelines for quality assurance in colorectal cancer screening and diagnosis and leads the World Endoscopy Organization Colorectal Cancer Committee’s Expert Working Group on ‘FIT for Screening’.

Automatic classification of DMSA scans using an artificial neural network

DMSA imaging is carried out in nuclear medicine to assess the level of functional renal tissue in patients. This study investigated the use of an artificial neural network to perform diagnostic classification of these scans. Using the radiological report as the gold standard, the network was trained to classify DMSA scans as positive or negative for defects using a representative sample of 257 previously reported images. The trained network was then independently tested using a further 193 scans and achieved a binary classification accuracy of 95.9%. The performance of the network was compared with three qualified expert observers who were asked to grade each scan in the 193 image testing set on a six point defect scale, from ‘definitely normal’ to ‘definitely abnormal’. A receiver operating characteristic analysis comparison between a consensus operator, generated from the scores of the three expert observers, and the network revealed a statistically significant increase (α < 0.05) in performance between the network and operators. A further result from this work was that when suitably optimized, a negative predictive value of 100% for renal defects was achieved by the network, while still managing to identify 93% of the negative cases in the dataset. These results are encouraging for application of such a network as a screening tool or quality assurance assistant in clinical practice.

Guideline for Determining the Mean Glandular Dose According to DIN 6868-162 and Threshold Contrast Visibility According to the Quality Assurance Guideline for Digital Mammography Systems

As part of the physico-technical quality assurance of the German breast cancer screening program, the threshold contrast visibility and the average glandular dose of every digital mammography system have to fulfill the requirements of the "European guidelines for quality assurance in breast cancer screening and diagnosis" (4th Edition). To accomplish uniform measurements in all federal states of Germany, the physical board of the reference centers developed a special guideline in 2009. Due to recent changes in the guidelines and standards, a second version of the guideline was developed by the reference centers. This guideline describes the determination of the average glandular dose as well as the CDMAM image acquisition and the CDMAM image evaluation. The determination of the threshold contrast visibility can be performed visually or automatically. The determination of the average glandular dose is based on DIN 6868 - 162 and the threshold contrast visibility test is based on the German "Quality Assurance Guideline".

精度管理の標準化に伴う品質管理の諸問題

がん検診の目的である乳癌死亡を減少させるためには，有効性のある検診方法で精度の高い検診を多くの対象者に行う必要がある。精度の高いマンモグラフィ検診は，検診，精密検査施設に関わらず，高品質のマンモグラムで高い読影を行うことが求められている。そのため，マンモグラフィ検診精度管理中央委員会(現 日本乳がん検診精度管理中央機構；精中機構)・施設画像評価委員会は，2004年9月からアナログ画像とデジタル画像を，2012年4月からはソフトコピー画像評価の活動を行っている。本パネルディスカッションでは，施設画像評価からみた精度管理の標準化に伴うデジタルマンモグラフィの品質管理における諸問題を検討し，改善策の話題を提供した。

マンモグラフィによる乳がん検診における精度管理の必要性

マンモグラフィによる乳がん検診における精度管理の必要性

Participation rate or informed choice? Rethinking the European key performance indicators for mammography screening

Despite the intensive controversies about the likelihood of benefits and harms of mammography screening almost all experts conclude that the choice to screen or not to screen needs to be made by the individual patient who is adequately informed. However, the “European guideline for quality assurance in breast cancer screening and diagnosis” specifies a participation rate of 70% as the key performance indicator for mammography screening. This paper argues that neither the existing evidence on benefits and harms, nor survey research with women, nor compliance rates in clinical trials, nor cost-effectiveness ratios justify participation rates as a reasonable performance indicator for preference-sensitive condition such as mammography screening. In contrast, an informed choice rate would be more reasonable. Further research needs to address the practical challenges in assessing informed choice rates.

Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Early colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Early colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Breast cancer screening: Current status

The currently available scientific evidence attests that mammographic screening and quality treatment have been able to reduce mortality attributable to breast cancer. Although screening is not without risks, population-based screening has clear advantages over opportunistic detection. Following the Council of the European Union's “Recommendations on cancer screening”, all the regional Autonomous Communities in Spain have screening programs that, in general, follow the same guidelines. The “European guidelines for quality assurance in breast cancer screening and diagnosis” serve as a reference that provides an overview of all aspects of screening. To achieve the foreseen objectives for the reduction of the morbidity and mortality attributable to breast cancer, screening programs must fulfill the established quality criteria and guarantee that patients have access to the best treatment options.

Screening for Cervical Cancer - Minimise Risks - Maximise Benefits. Need for Adaptation in Germany in Light of the European Guidelines and Their Objectives

The national cancer plan calls for adjustment of the early detection scheme for cervical cancer to the quality requirements of the “European guidelines for quality assurance in cervical cancer screening”. The existing scheme should be further developed and carried out in an organized, population-based framework. The objective is to lower the incidence and mortality of cervical cancer while minimising the risks and optimising the benefits of the scheme. The self-determined choice of the patients should be respected. The competence for this task falls in the medical field of activity. The adaptation includes an organisational further development and, in part, re-organisation of the established early detection scheme for cervical cancer. If the national cancer plan is considered as a concept for the discursive further development of the healthcare, the experts from different areas of the system are encouraged to participate. To go to a new version of the national directive for early detection of cancer that will define the procedure in the Federal Republic in future first requires a consensus of the fields of action with regard to the specified objectives of the transformation. The heterogeneity of the approaches in Europe (even within individual countries) as well as the results clearly show that Germany has to find and define its own pathway. The presented overview of the pending fields of action could serve as a basis for the development process and the work of a multisectoral task force in the field of gynaecology.

Development and implementation of guidelines for quality assurance in breast cancer screening: The European experience

In Europe, as in many other regions of the world, breast cancer is a major cause of suffering and death. Early detection of breast cancer by systematic mammography screening can find lesions for which treatment is more effective and generally more favourable for quality of life. Comprehensive quality assurance guidelines for breast cancer screening based on mammography have been developed in the Europe Against Cancer programme with the aim of maximising screening benefits while minimising adverse effects, such as unnecessary examination or treatment resulting from false-positive screening tests. The present report provides an overview of the European experience in developing and implementing quality assurance guidelines for breast cancer screening. It highlights implications relevant to those regions of the world in which the burden of breast cancer in the coming years will make population-based screening an option for cancer control.

European guidelines for quality assurance in colorectal cancer screening and diagnosis: Overview and introduction to the full Supplement publication

Population-based screening for early detection and treatment of colorectal cancer (CRC) and precursor lesions, using evidence-based methods, can be effective in populations with a significant burden of the disease provided the services are of high quality. Multidisciplinary, evidence-based guidelines for quality assurance in CRC screening and diagnosis have been developed by experts in a project co-financed by the European Union. The 450-page guidelines were published in book format by the European Commission in 2010. They include 10 chapters and over 250 recommendations, individually graded according to the strength of the recommendation and the supporting evidence. Adoption of the recommendations can improve and maintain the quality and effectiveness of an entire screening process, including identification and invitation of the target population, diagnosis and management of the disease and appropriate surveillance in people with detected lesions. To make the principles, recommendations and standards in the guidelines known to a wider professional and scientific community and to facilitate their use in the scientific literature, the original content is presented in journal format in an open-access Supplement of Endoscopy. The editors have prepared the present overview to inform readers of the comprehensive scope and content of the guidelines.

European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition – Organisation

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on organisation includes 29 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of the screening process, including multi-disciplinary diagnosis and management of the disease.