LitCovid-sentences  

PubMed:33419461 JSONTXT 11 Projects

Annnotations TAB TSV DIC JSON TextAE

Id Subject Object Predicate Lexical cue
T1 0-236 Sentence denotes Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): a structured summary of a study protocol for a cluster-randomised, two-factorial controlled trial.
T2 237-248 Sentence denotes OBJECTIVES:
T3 249-531 Sentence denotes In this cluster-randomised controlled study (CoV-Surv Study), four different "active" SARS-CoV-2 testing strategies for general population surveillance are evaluated for their effectiveness in determining and predicting the prevalence of SARS-CoV-2 infections in a given population.
T4 532-631 Sentence denotes In addition, the costs and cost-effectiveness of the four surveillance strategies will be assessed.
T5 632-743 Sentence denotes Further, this trial is supplemented by a qualitative component to determine the acceptability of each strategy.
T6 744-1016 Sentence denotes Findings will inform the choice of the most effective, acceptable and affordable strategy for SARS-CoV-2 surveillance, with the most effective and cost-effective strategy becoming part of the local public health department's current routine health surveillance activities.
T7 1017-1299 Sentence denotes Investigating its everyday performance will allow us to examine the strategy's applicability to real time prevalence prediction and the usefulness of the resulting information for local policy makers to implement countermeasures that effectively prevent future nationwide lockdowns.
T8 1300-1519 Sentence denotes The authors would like to emphasize the importance and relevance of this study and its expected findings in the context of population-based disease surveillance, especially in respect to the current SARS-CoV-2 pandemic.
T9 1520-1835 Sentence denotes In Germany, but also in many other countries, COVID-19 surveillance has so far largely relied on passive surveillance strategies that identify individuals with clinical symptoms, monitor those cases who then tested positive for the virus, followed by tracing of individuals in close contact to those positive cases.
T10 1836-2066 Sentence denotes To achieve higher effectiveness in population surveillance and to reliably predict the course of an outbreak, screening and monitoring of infected individuals without major symptoms (about 40% of the population) will be necessary.
T11 2067-2355 Sentence denotes While current testing capacities are also used to identify such asymptomatic cases, this rather passive approach is not suitable in generating reliable population-based estimates of the prevalence of asymptomatic carriers to allow any dependable predictions on the course of the pandemic.
T12 2356-2656 Sentence denotes To better control and manage the SARS-CoV-2 pandemic, current strategies therefore need to be complemented by an active surveillance of the wider population, i.e. routinely conducted testing and monitoring activities to identify and isolate infected individuals regardless of their clinical symptoms.
T13 2657-2838 Sentence denotes Such active surveillance strategies will enable more effective prevention of the spread of the virus as they can generate more precise population-based parameters during a pandemic.
T14 2839-2998 Sentence denotes This essential information will be required in order to determine the best strategic and targeted short-term countermeasures to limit infection spread locally.
T15 2999-3012 Sentence denotes TRIAL DESIGN:
T16 3013-3231 Sentence denotes This trial implements a cluster-randomised, two-factorial controlled, prospective, interventional, single-blinded design with four study arms, each representing a different SARS-CoV-2 testing and surveillance strategy.
T17 3232-3245 Sentence denotes PARTICIPANTS:
T18 3246-3445 Sentence denotes Eligible are individuals age 7 years or older living in Germany's Rhein-Neckar Region who consent to provide a saliva sample (all four arms) after completion of a brief questionnaire (two arms only).
T19 3446-3636 Sentence denotes For the qualitative component, different samples of study participants and non-participants (i.e. eligible for study, but refuse to participate) will be identified for additional interviews.
T20 3637-3711 Sentence denotes For these interviews, only individuals age 18 years or older are eligible.
T21 3712-3740 Sentence denotes INTERVENTION AND COMPARATOR:
T22 3741-3917 Sentence denotes Of the four surveillance strategies to be assessed and compared, Strategy A1 is considered the gold standard for prevalence estimation and used to determine bias in other arms.
T23 3918-4061 Sentence denotes To determine the cost-effectiveness, each strategy is compared to status quo, defined as the currently practiced passive surveillance approach.
T24 4062-4074 Sentence denotes Strategy A1:
T25 4075-4243 Sentence denotes Individuals (one per household) receive information and study material by mail with instructions on how to produce a saliva sample and how to return the sample by mail.
T26 4244-4390 Sentence denotes Once received by the laboratory, the sample is tested for SARS-CoV-2 using Reverse Transcription Loop-mediated Isothermal Amplification (RT-LAMP).
T27 4391-4403 Sentence denotes Strategy A2:
T28 4404-4622 Sentence denotes Individuals (one per household) receive information and study material by mail with instructions on how to produce their own as well as saliva samples from each household member and how to return these samples by mail.
T29 4623-4708 Sentence denotes Once received by the laboratory, the samples are tested for SARS-CoV-2 using RT-LAMP.
T30 4709-4721 Sentence denotes Strategy B1:
T31 4722-4908 Sentence denotes Individuals (one per household) receive information by mail on how to complete a brief pre-screening questionnaire which asks about COVID-19 related clinical symptoms and risk exposures.
T32 4909-5122 Sentence denotes Only individuals whose pre-screening score crosses a defined threshold, will then receive additional study material by mail with instructions on how to produce a saliva sample and how to return the sample by mail.
T33 5123-5213 Sentence denotes Once received by the laboratory, the saliva sample is tested for SARS-CoV-2 using RT-LAMP.
T34 5214-5226 Sentence denotes Strategy B2:
T35 5227-5394 Sentence denotes Individuals (one per household) receive information by mail on how to complete a brief pre-screening questionnaire which asks about COVID-19 related clinical symptoms.
T36 5395-5655 Sentence denotes Only individuals whose pre-screening score crosses a defined threshold, will then receive additional study material by mail with instructions how to produce their own as well as saliva samples from each household member and how to return these samples by mail.
T37 5656-5741 Sentence denotes Once received by the laboratory, the samples are tested for SARS-CoV-2 using RT-LAMP.
T38 5742-5872 Sentence denotes In each strategy, RT-LAMP positive samples are additionally analyzed with qPCR in order to minimize the number of false positives.
T39 5873-5887 Sentence denotes MAIN OUTCOMES:
T40 5888-5974 Sentence denotes The identification of the one best strategy will be determined by a set of parameters.
T41 5975-6128 Sentence denotes Primary outcomes include costs per correctly screened person, costs per positive case, positive detection rate, and precision of positive detection rate.
T42 6129-6354 Sentence denotes Secondary outcomes include participation rate, costs per asymptomatic case, prevalence estimates, number of asymptomatic cases per study arm, ratio of symptomatic to asymptomatic cases per study arm, participant satisfaction.
T43 6355-6794 Sentence denotes Additional study components (not part of the trial) include cost effectiveness of each of the four surveillance strategies compared to passive monitoring (i.e. status quo), development of a prognostic model to predict hospital utilization caused by SARS-CoV-2, time from test shipment to test application and time from test shipment to test result, and perception and preferences of the persons to be tested with regard to test strategies.
T44 6795-6809 Sentence denotes RANDOMISATION:
T45 6810-6871 Sentence denotes Samples are drawn in three batches of three continuous weeks.
T46 6872-6914 Sentence denotes Randomisation follows a two-stage process.
T47 6915-7004 Sentence denotes First, a total of 220 sampling points have been allocated to the three different batches.
T48 7005-7092 Sentence denotes To obtain an integer solution, the Cox-algorithm for controlled rounding has been used.
T49 7093-7222 Sentence denotes Afterwards, sample points have been drawn separately per batch, following a probability proportional to size (PPS) random sample.
T50 7223-7377 Sentence denotes Second, for each cluster the same number of residential addresses is randomly sampled from the municipal registries (self-weighted sample of individuals).
T51 7378-7669 Sentence denotes The 28,125 addresses drawn per municipality are then randomly allocated to the four study arms A1, A2, B1, and B2 in the ratio 5 to 2.5 to 14 to 7 based on the expected response rates in each arm and the sensitivity and specificity of the pre-screening tool as applied in strategy B1 and B2.
T52 7670-7762 Sentence denotes Based on the assumptions, this allocation should yield 2500 saliva samples in each strategy.
T53 7763-7950 Sentence denotes Although a municipality can be sampled by multiple batches and the overall number of addresses per municipality might vary, the number of addresses contacted in each arm is kept constant.
T54 7951-7970 Sentence denotes BLINDING (MASKING):
T55 7971-8134 Sentence denotes The design is single-blinded, meaning the staff conducting the SARS-CoV-2 tests are unaware of the study arm assignment of each single participant and test sample.
T56 8135-8148 Sentence denotes SAMPLE SIZES:
T57 8149-8281 Sentence denotes Total sample size for the trial is 10,000 saliva samples equally allocated to the four study arms (i.e. 2,500 participants per arm).
T58 8282-8658 Sentence denotes For the qualitative component, up to 60 in-depth interviews will be conducted with about 30 study participants (up to 15 in each arm A and B) and 30 participation refusers (up to 15 in each arm A and B) purposefully selected from the quantitative study sample to represent a variety of gender and ages to explore experiences with admission or rejection of study participation.
T59 8659-8974 Sentence denotes Up to 25 asymptomatic SARS-CoV-2 positive study participants will be purposefully selected to explore the way in which asymptomatic men and women diagnosed with SARS-CoV-2 give meaning to their diagnosis and to the dialectic between feeling concurrently healthy and yet also being at risk for transmitting COVID-19.
T60 8975-9123 Sentence denotes In addition, 100 randomly selected study participants will be included to explore participants' perspective on testing processes and implementation.
T61 9124-9137 Sentence denotes TRIAL STATUS:
T62 9138-9233 Sentence denotes Final protocol version is "Surveillance_Studienprotokoll_03Nov2020_v1_2" from November 3, 2020.
T63 9234-9326 Sentence denotes Recruitment started November 18, 2020 and is expected to end by or before December 31, 2020.
T64 9327-9346 Sentence denotes TRIAL REGISTRATION:
T65 9347-9545 Sentence denotes The trial is currently being registered with the German Clinical Trials Register (Deutsches Register Klinischer Studien), DRKS00023271 ( https://www.drks.de/drks_web/navigate.do?navigationId=trial .
T66 9546-9574 Sentence denotes HTML&TRIAL_ID=DRKS00023271).
T67 9575-9619 Sentence denotes Retrospectively registered 30 November 2020.
T68 9620-9634 Sentence denotes FULL PROTOCOL:
T69 9635-9743 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T70 9744-9924 Sentence denotes In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.