Correction: Comparison of Four Active SARS-CoV-2 Surveillance Strategies in Representative Population Sample Points: Two-Factor Factorial Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/44204.].

Strengthening national public health institutes: a systematic review on institution building in the public sector.

Introduction: Strong and efficient institutions are vital to the development of well-functioning governments and strong societies. The term "institution building" encompasses the creation, support, development, and strengthening of organizations and institutions. Still, there is little aggregated evidence on "institution building" considering a wider system-thinking approach, best practices, or development cooperation specifically in the field of public health. In 2007, the International Association of National Public Health Institutes (IANPHI) created a guiding Framework that countries may use for developing National Public Health Institutes (NPHIs). This Framework is currently being revised. Methods: In this context, we conducted a systematic review to facilitate this revision with recent evidence on institution building and its potential contribution to NPHI. We followed the PRISMA guidelines for systematic reviews, searching for relevant publications in seven scientific databases (Pubmed, VHL/LILACS, EconLit, Google Scholar, Web of Science, World Affairs Online, ECONBIZ) and four libraries (World Bank; European Health for All database of the World Health Organization European Region, WHO; Organization for Economic Cooperation and Development, OECD; and the African Union Common Repository). The search was carried out in October 2021. We used the "framework analysis" tool for systematically processing documents according to key themes. Results: As a result, we identified 3,015 records, of which we included 62 documents in the final review. This systematic review fills a major gap of aggregated information on institution building in the field of public health and National Public Health Institutes. It is to our knowledge the first systematic review of this kind. The overriding result is the identification and definition of six domains of institution building in the health sector: "governance," "knowledge and innovation," "inter-institutional cooperation," "monitoring and control," "participation," and "sustainability and context-specific adaptability." Discussion: Our results show that the described domains are highly relevant to the public health sector, and that managers and the scientific community recognize their importance. Still, they are often not applied consistently when creating or developing NPHIs. We conclude that organizations engaged in institution building of NPHIs, including IANPHI, may greatly benefit from state-of-the-art research on institution building as presented in this study.

Comparison of Four Active SARS-CoV-2 Surveillance Strategies in Representative Population Sample Points: Two-Factor Factorial Randomized Controlled Trial.

BACKGROUND: The COVID-19 pandemic is characterized by rapid increases in infection burden owing to the emergence of new variants with higher transmissibility and immune escape. To date, monitoring the COVID-19 pandemic has mainly relied on passive surveillance, yielding biased epidemiological measures owing to the disproportionate number of undetected asymptomatic cases. Active surveillance could provide accurate estimates of the true prevalence to forecast the evolution of the pandemic, enabling evidence-based decision-making. OBJECTIVE: This study compared 4 different approaches of active SARS-CoV-2 surveillance focusing on feasibility and epidemiological outcomes. METHODS: A 2-factor factorial randomized controlled trial was conducted in 2020 in a German district with 700,000 inhabitants. The epidemiological outcome comprised SARS-CoV-2 prevalence and its precision. The 4 study arms combined 2 factors: individuals versus households and direct testing versus testing conditioned on symptom prescreening. Individuals aged ≥7 years were eligible. Altogether, 27,908 addresses from 51 municipalities were randomly allocated to the arms and 15 consecutive recruitment weekdays. Data collection and logistics were highly digitized, and a website in 5 languages enabled low-barrier registration and tracking of results. Gargle sample collection kits were sent by post. Participants collected a gargle sample at home and mailed it to the laboratory. Samples were analyzed with reverse transcription loop-mediated isothermal amplification (RT-LAMP); positive and weak results were confirmed with real-time reverse transcription-polymerase chain reaction (RT-PCR). RESULTS: Recruitment was conducted between November 18 and December 11, 2020. The response rates in the 4 arms varied between 34.31% (2340/6821) and 41.17% (2043/4962). The prescreening classified 16.61% (1207/7266) of the patients as COVID-19 symptomatic. Altogether, 4232 persons without prescreening and 7623 participating in the prescreening provided 5351 gargle samples, of which 5319 (99.4%) could be analyzed. This yielded 17 confirmed SARS-CoV-2 infections and a combined prevalence of 0.36% (95% CI 0.14%-0.59%) in the arms without prescreening and 0.05% (95% CI 0.00%-0.108%) in the arms with prescreening (initial contacts only). Specifically, we found a prevalence of 0.31% (95% CI 0.06%-0.58%) for individuals and 0.35% (95% CI 0.09%-0.61%) for households, and lower estimates with prescreening (0.07%, 95% CI 0.0%-0.15% for individuals and 0.02%, 95% CI 0.0%-0.06% for households). Asymptomatic infections occurred in 27% (3/11) of the positive cases with symptom data. The 2 arms without prescreening performed the best regarding effectiveness and accuracy. CONCLUSIONS: This study showed that postal mailing of gargle sample kits and returning home-based self-collected liquid gargle samples followed by high-sensitivity RT-LAMP analysis is a feasible way to conduct active SARS-CoV-2 population surveillance without burdening routine diagnostic testing. Efforts to improve participation rates and integration into the public health system may increase the potential to monitor the course of the pandemic. TRIAL REGISTRATION: Deutsches Register Klinischer Studien (DRKS) DRKS00023271; https://tinyurl.com/3xenz68a. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-021-05619-5.

Cost and cost-effectiveness of four different SARS-CoV-2 active surveillance strategies: evidence from a randomised control trial in Germany.

INTRODUCTION: The COVID-19 pandemic has entered its third year and continues to affect most countries worldwide. Active surveillance, i.e. testing individuals irrespective of symptoms, presents a promising strategy to accurately measure the prevalence of SARS-CoV-2. We aimed to identify the most cost-effective active surveillance strategy for COVID-19 among the four strategies tested in a randomised control trial between 18th November 2020 and 23rd December 2020 in Germany. The four strategies included: (A1) direct testing of individuals; (A2) direct testing of households; (B1) testing conditioned on upstream COVID-19 symptom pre-screening of individuals; and (B2) testing conditioned on upstream COVID-19 symptom pre-screening of households. METHODS: We adopted a health system perspective and followed an activity-based approach to costing. Resource consumption data were collected prospectively from a digital individual database, daily time records, key informant interviews and direct observations. Our cost-effectiveness analysis compared each strategy with the status quo and calculated the average cost-effective ratios (ACERs) for one primary outcome (sample tested) and three secondary outcomes (responder recruited, case detected and asymptomatic case detected). RESULTS: Our results showed that A2, with cost per sample tested at 52,89 EURO, had the lowest ACER for the primary outcome, closely followed by A1 (63,33 EURO). This estimate was much higher for both B1 (243,84 EURO) and B2 (181,06 EURO). CONCLUSION: A2 (direct testing at household level) proved to be the most cost-effective of the four evaluated strategies and should be considered as an option to strengthen the routine surveillance system in Germany and similar settings.

Mental health indicators for children and adolescents in OECD countries: a scoping review.

Background: This scoping review is a further step to build up the Mental Health Surveillance System for Germany. It summarizes and analyzes indicators used or described in Organization for Economic Co-operation and Development (OECD) countries for public mental health monitoring in children and adolescents aged 0-18 years. Methods: We searched PubMed-MEDLINE, PsycINFO, Cochrane Databases, and Google Scholar from 2000 to September 2022. The search used five general keyword categories: 1) "indicators/monitoring/surveillance" at the population level, 2) "mental/psychological," 3) "health/disorders," 4) "children and adolescents," and 5) 38 OECD countries. The search was complemented with an extensive grey literature search, including OECD public health institutions and an internet search using Google. A predefined set of inclusion and exclusion criteria was applied. Results: Over 15,500 articles and documents were screened (scientific search N = 10,539, grey literature search more than 5,000). More than 700 articles and documents have been full-text assessed, with 382 being ultimately included. Out of 7,477 indicators extracted, an initial set of 6,426 indicators met our inclusion criteria for indicators. After consolidating duplicates and similar content, this initial set was categorized into 19 topics, resulting in a final set of 210 different indicators. The analysis highlighted an increasing interest in the topic since 2008, but indicators for the younger age, particularly those aged 0 to 2 years, were less readily available. Conclusion: Our research provides a comprehensive understanding of the current state of mental health indicators for children and adolescents, identifying both (1) indicators of public mental health noted in a previous scoping review on adults and (2) new indicators specific to this age group. These findings contribute to the development of effective public health surveillance strategies for children and adolescents and inform future research in this field.

From disgusting and complicated to simple and brilliant: Implementation perspectives and lessons learned from users and rejectors of mail-in SARS-CoV-2 gargle tests.

Background: Despite the important role of testing as a measure against the COVID-19 pandemic, user perspectives on SARS-CoV-2 tests remain scarce, inhibiting an improvement of testing approaches. As the world enters the third year of the pandemic, more nuanced perspectives of testing, and opportunities to expand testing in a feasible and affordable manner merit consideration. Methods: Conducted amid the second pandemic wave (late 2020-early 2021) during and after a multi-arm trial evaluating SARS-CoV-2 surveillance strategies in the federal state Baden-Württemberg, Germany, this qualitative sub-study aimed to gain a deeper understanding of how test users and test rejectors perceived mail-in SARS-CoV-2 gargle tests. We conducted 67 semi-structured in-depth interviews (mean duration: 60 min) via telephone or video call. Interviews were audio-recorded, transcribed verbatim and analyzed inductively using thematic analysis. The Consolidated Framework for Implementation Research guided the findings' presentation. Results: Respondents generally described gargle sampling as simple and comfortable. However, individual perceptions of the testing method and its feasibility varied widely from disgusting and complicated to simple and brilliant. Self-sampling was appreciated for lowering infection risks during testing, but also considered more complex. Gargle-sampling increased participants' self-efficacy to sample correctly. Communication (first contact, quantity and content of information, reminders, support system) and trust (in the study, its institutional affiliation and test method) decisively influenced the intervention's acceptability. Conclusion: User-driven insights on how to streamline testing include: consider communication, first impressions of tests and information as key for successful mail-in testing; pay attention to the role of mutual trust between those taking and administering tests; implement gargle self-sampling as a pleasant alternative to swab testing; offer multiple test methods to increase test up-take.

Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): study protocol for a two-factorial randomized controlled multi-arm trial with cluster sampling.

BACKGROUND: To achieve higher effectiveness in population-based SARS-CoV-2 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. 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. METHODS: This trial implements a two-factorial, randomized, controlled, multi-arm, prospective, interventional, single-blinded design with cluster sampling and four study arms, each representing a different SARS-CoV-2 testing and surveillance strategy based on individuals' self-collection of saliva samples which are then sent to and analyzed by a laboratory. The targeted sample size for the trial is 10,000 saliva samples equally allocated to the four study arms (2500 participants per arm). Strategies differ with respect to tested population groups (individuals vs. all household members) and testing approach (without vs. with pre-screening survey). The trial is complemented by an economic evaluation and qualitative assessment of user experiences. Primary outcomes include costs per completely screened person, costs per positive case, positive detection rate, and precision of positive detection rate. DISCUSSION: Systems for active surveillance of the general population will gain more importance in the context of pandemics and related disease prevention efforts. The pandemic parameters derived from such active surveillance with routine population monitoring therefore not only enable a prospective assessment of the short-term course of a pandemic, but also a more targeted and thus more effective use of local and short-term countermeasures. TRIAL REGISTRATION: ClinicalTrials.gov DRKS00023271 . Registered November 30, 2020, with the German Clinical Trials Register (Deutsches Register Klinischer Studien).

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.

OBJECTIVES: 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. In addition, the costs and cost-effectiveness of the four surveillance strategies will be assessed. Further, this trial is supplemented by a qualitative component to determine the acceptability of each strategy. 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. 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. 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. 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. 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. 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. 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. 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. This essential information will be required in order to determine the best strategic and targeted short-term countermeasures to limit infection spread locally. TRIAL DESIGN: 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. PARTICIPANTS: 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). 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. For these interviews, only individuals age 18 years or older are eligible. INTERVENTION AND COMPARATOR: 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. To determine the cost-effectiveness, each strategy is compared to status quo, defined as the currently practiced passive surveillance approach. Strategy A1: 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. Once received by the laboratory, the sample is tested for SARS-CoV-2 using Reverse Transcription Loop-mediated Isothermal Amplification (RT-LAMP). Strategy A2: 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. Once received by the laboratory, the samples are tested for SARS-CoV-2 using RT-LAMP. Strategy B1: 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. 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. Once received by the laboratory, the saliva sample is tested for SARS-CoV-2 using RT-LAMP. Strategy B2: 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. 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. Once received by the laboratory, the samples are tested for SARS-CoV-2 using RT-LAMP. In each strategy, RT-LAMP positive samples are additionally analyzed with qPCR in order to minimize the number of false positives. MAIN OUTCOMES: The identification of the one best strategy will be determined by a set of parameters. Primary outcomes include costs per correctly screened person, costs per positive case, positive detection rate, and precision of positive detection rate. 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. 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. RANDOMISATION: Samples are drawn in three batches of three continuous weeks. Randomisation follows a two-stage process. First, a total of 220 sampling points have been allocated to the three different batches. To obtain an integer solution, the Cox-algorithm for controlled rounding has been used. Afterwards, sample points have been drawn separately per batch, following a probability proportional to size (PPS) random sample. Second, for each cluster the same number of residential addresses is randomly sampled from the municipal registries (self-weighted sample of individuals). 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. Based on the assumptions, this allocation should yield 2500 saliva samples in each strategy. 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. BLINDING (MASKING): 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. SAMPLE SIZES: 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). 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. 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. In addition, 100 randomly selected study participants will be included to explore participants' perspective on testing processes and implementation. TRIAL STATUS: Final protocol version is "Surveillance_Studienprotokoll_03Nov2020_v1_2" from November 3, 2020. Recruitment started November 18, 2020 and is expected to end by or before December 31, 2020. TRIAL REGISTRATION: 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 . HTML&TRIAL_ID=DRKS00023271). Retrospectively registered 30 November 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). 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.

How to prioritise in quality improvement? Targeted implementation as a key for quality improvement in Kenyan health facilities.

BACKGROUND: Data from national surveys of low- and middle income countries indicates that there is still a need to improve the quality of healthcare in resource-poor settings. This study aims to understand the benefit of an integral, facility-driven, indicator-based approach used as a decision-making tool to define effective quality improvement interventions in Kenya. OBJECTIVE: The aim of the study is to understand whether the integral approach developed leads to effective interventions. METHODS: Categorical data is collected from ten health facilities covered by the Integrated Quality Management System (IQMS) project in Kenya. First the information on concrete improvement interventions implemented within the facilities is collected and merged into five different intervention topics. Second, groups of facilities with similar quality improvement interventions are selected to compare between the first and second quality assessment rounds. Those IQMS indicators matching the content of the intervention topic are extracted from the software VISOTOOL. In a third step, the data is summarised using means and SD. A one sample T-test is applied on the mean changes and SD. Frequency counts and percentages were used for the presentation of categorical data. RESULTS: All improvement interventions resulted in positive and higher change values (T2-T1). Four of five intervention topics, show statistically significant improvements including neonatal mortality (42%; p<0.0001), waiting time (39%; p=0.0490), infection prevention control (28%; p=0.0007) and with shortages of staffing and transport in remote areas (32%; p=0.0194). CONCLUSIONS: In all facilities the interventions selected have a positive impact, some of which markedly improved. It demonstrates that this integral quality improvement approach in Kenya can serve as an effective decision-making tool for identification and prioritisation of interventions. Those targeted interventions, being performed under institutionalisation in form of coaching and tutoring, effectively contribute to improving the quality of care in resource poor settings.

Quality improvement of health systems in an epidemic context: A framework based on lessons from the Ebola virus disease outbreak in West Africa.

Quality improvement (QI) in health generally focuses on the provision of health services with the aim of improving service delivery. Yet QI can be applied not only to health services but also to health systems overall. This is of growing relevance considering that due to deficiencies in health systems, the main countries affected by Ebola virus disease (EVD) outbreak in West Africa (2014-2016) were insufficiently prepared for the epidemic, and according to the WHO, epidemics are increasingly becoming a threat to global health. Our objective is to analyze QI constraints in health systems during that EVD epidemic and to propose a practical framework for QI in health systems for epidemics in developing countries. We applied a framework analysis using experiences shared at the "Second International Quality Forum" organized by the University of Heidelberg and partners in July 2015 and information gathered from a systematic literature review. Empirical results revealed multiple deficiencies in the health systems. We systemized these shortfalls as well as the QI measures taken as a response during the epidemic. On the basis of these findings, we identified six specific "priority intervention areas," which ultimately resulted in the synthesis of a practical QI framework. We deem that this framework that integrates the priority intervention areas with the WHO building blocks is suitable to improve, monitor, and evaluate health system performance in epidemic contexts in developing countries.