Persistent infection with high-risk human papillomavirus (HPV) is the causative agent for cervical cancer (1, 2). Testing for HPV DNA provides better protection against cervical cancer and its precursors, i.e., high-grade cervical intraepithelial neoplasia (CIN), compared to cytology (3-7). For primary cervical cancer screening, it is crucial that the HPV assays that are used are clinically validated to ensure optimal distinction between HPV infections associated with CIN grade 2 or worse (CIN2ϩ) and clinically irrelevant transient HPV infections (8,9).A variety of HPV DNA detection assays are currently considered clinically validated with cervical scraping specimens for cervical cancer screening purposes. Validation has been based on either data from large prospective screening trials (i.e., high-risk HPV Hybrid Capture 2 [HC2] and GP5ϩ/6ϩ PCR) (3, 5, 6, 10) or cross-sectional clinical equivalence analyses according to international guidelines (8, 9) for HPV DNA test requirements (11-13). In addition to clinician-based sampling, HPV self-sampling is an emerging effective strategy for cervical screening. Offering HPV testing on self-collected cervicovaginal specimens reattracts a substantial number of nonattendees into the screening program and effectively detects CIN2ϩ (14, 15). However, standardization of the collection device, HPV test, and sample preparation protocols is important to minimize variations in the CIN2ϩ sensitivity and specificity of HPV self-sampling (reviewed in reference 16). It must be realized that the use of an HPV test that is clinically validated for cervical scraping specimens does not automatically result in high clinical accuracy when it is applied to self-collected specimens (17). Therefore, a separate analysis of the candidate HPV test with self-collected samples, relative to its performance with cervical scraping specimens, is important to ensure suitability for HPV self-sampling. Given the potential variations in target cell yields between different self-samplers (16), such a comparative accuracy analysis ideally should be performed for each selfsampler type, in order to determine the best combination of selfsampler and validated HPV test.Most assays validated for cervical screening purposes use PCRbased assays targeting regions within the HPV E1 or L1 open reading frames (11,13,18). However, malignant progression of cervical lesions is often associated with viral DNA integration into the genome of the host cell (19). Integration often takes place between
Anyplex™ II HPV HR Detection performs clinically non-inferior to HR HPV GP5+/6+-PCR-EIA. Anyplex™ II HPV HR Detection complies with international consensus validation metrics for HPV DNA tests for cervical cancer screening [1].
cThis study showed that the Abbott RealTime High Risk HPV assay fulfilled cross-sectional clinical equivalence and reproducibility criteria of international consensus guidelines, which indicates that this assay can be considered clinically validated for cervical cancer screening purposes. Since infection with high-risk human papillomavirus (hrHPV) is the main causative factor for cervical cancer development, hrHPV testing has been recognized as primary cervical screening tool and is likely to be adopted soon in many countries. However, it is imperative that hrHPV DNA assays to be used for primary cervical screening be clinically validated to ensure, over and above a high clinical sensitivity, a high clinical specificity for cervical intraepithelial neoplasia grade 2/3 and cervical cancer (CIN2ϩ). The latter is important to minimize follow-up procedures done for hrHPV test-positive women without clinically meaningful disease (ϽCIN2), whose infection will generally disappear spontaneously. Clinical validation of a candidate hrHPV DNA assay for screening can be performed by cross-sectional clinical equivalence analysis of the assay relative to one of the established clinically validated reference assays, i.e., high-risk HPV hybrid capture 2 (HC2) or GP5ϩ/6ϩ PCR, as outlined by an international consortium (1, 2). According to these guidelines, candidate assays should exhibit clinical noninferiority to HC2 or GP5ϩ/6ϩ PCR (i.e., relative sensitivity for CIN2ϩ of Ն0.90 and specificity for CIN2ϩ of Ն0.98), and show a sufficiently high intralaboratory reproducibility and interlaboratory agreement (i.e., both showing a percentage of agreement with a lower confidence bound not less than 87% [kappa value of at least 0.5]) to be clinically validated. Several hrHPV assays recently have been partially or completely clinically validated using these criteria (3-5).The Abbott RealTime High Risk (HR) HPV assay is an automated multiplex real-time PCR test that targets the (GP5ϩ/6ϩ) L1 region of 14 hrHPV types (6). It includes an internal sample control (IC; human -globin PCR), and four distinct fluorescent labels allow the separate detection of DNA from HPV16, HPV18, a pool of 12 other high-risk genotypes (i.e., HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV66, and HPV68), and IC. The present study set out to clinically validate the Abbott RealTime HR HPV assay according to the international guidelines by comparing its clinical sensitivity and specificity for CIN2ϩ to that of GP5ϩ/6ϩ PCR and assessing intralaboratory reproducibility and interlaboratory agreement.For clinical sensitivity analysis, a representative set of 68 cervical samples was used. These cervical scrapes were collected within a population-based screening setting in the Utrecht and NorthHolland region of the Netherlands and were derived from women diagnosed with histologically confirmed CIN2ϩ (i.e., 30 CIN2, 34 CIN3, and 4 SCC diagnosed within 12 months from baseline sampling). These clinical cases were detected by cervical screening on ...
BackgroundPatients undergoing chemotherapy are highly burdened by side effects. These may be caused by the pharmacodynamics of the drug or be driven by psychological factors such as negative expectations or pre-conditioning, which reflect nocebo effects. As such, negative pre-treatment expectations or prior experiences might exacerbate the burden of chemotherapy side effects. Educating patients about this nocebo effect has been put forward as a potential strategy to optimize patients’ pre-treatment expectations. In this study, we evaluate whether a briefing about the nocebo effect is efficacious in reducing side effects.MethodsIn this exploratory study, a total number of n = 100 outpatients with newly diagnosed gastrointestinal cancers are randomized 1:1 to an information session about the nocebo effect (nocebo-education) or an attention control group (ACG) with matching interaction time. Assessments take place before the intervention (T1 pre), post-intervention (T1 post), and 10 days (T2) and 12 weeks (T3) after the initial chemotherapy. The primary outcomes are the patient-rated number and intensity of side effects at 10-days and at 12-weeks follow-up. Secondary outcomes include coping with side effects, tendency to misattribute symptoms, compliance intention, attitude towards the chemotherapy, co-medication to treat side effects and the clinician-rated severity of toxicity. Further analyses are conducted to investigate whether a potential beneficial effect is mediated by a change of expectations before and after the intervention.DiscussionInforming patients about the nocebo effect might be an innovative and feasible intervention to reduce the burden of side effects and strengthen patients’ perceived control over adverse symptoms.Trial registrationThe trial is registered at the German Clinical Trials Register (ID: DRKS00009501; retrospectively registered on March 27, 2018). The first patient was enrolled on September 29, 2015.
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