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Policymakers increasingly rely on behavioral science in response to global challenges, such as climate change or global health crises. But applications of behavioral science face an important problem: Interventions often exert substantially different effects across contexts and individuals. We examine this heterogeneity for different paradigms that underlie many behavioral interventions. We study the paradigms in a series of five preregistered studies across one in-person and 10 online panels, with over 11,000 respondents in total. We find substantial heterogeneity across settings and paradigms, apply techniques for modeling the heterogeneity, and introduce a framework that measures typically omitted moderators. The framework's factors (Fluid Intelligence, Attentiveness, Crystallized Intelligence, and Experience) affect the effectiveness of many text-based interventions, producing different observed effect sizes and explaining variations across samples. Moderators are associated with effect sizes through two paths, with the intensity of the manipulation and with the effect of the manipulation directly. Our results motivate observing these moderators and provide a theoretical and empirical framework for understanding and predicting varying effect sizes in the social sciences.
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Ciencias de la Conducta , Ciencias Sociales , Humanos , AtenciónRESUMEN
The American Heart Association/American Stroke Association released a revised spontaneous intracerebral hemorrhage guideline in 2022. A working group of stroke experts reviewed this guideline and identified a subset of recommendations that were deemed suitable for creating performance measures. These 15 performance measures encompass a wide spectrum of intracerebral hemorrhage patient care, from prehospital to posthospital settings, highlighting the importance of timely interventions. The measures also include 5 quality measures and address potential challenges in data collection, with the aim of future improvements.
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American Heart Association , Hemorragia Cerebral , Humanos , Hemorragia Cerebral/terapia , Estados Unidos , Accidente Cerebrovascular/terapia , Guías de Práctica Clínica como Asunto/normasRESUMEN
In this study, we compared location data from a dedicated Global Positioning System (GPS) device with location data from smartphones. Data from the Interventions, Equity, and Action in Cities Team (INTERACT) Study, a study examining the impact of urban-form changes on health in 4 Canadian cities (Victoria, Vancouver, Saskatoon, and Montreal), were used. A total of 337 participants contributed data collected for about 6 months from the Ethica Data smartphone application (Ethica Data Inc., Toronto, Ontario, Canada) and the SenseDoc dedicated GPS (MobySens Technologies Inc., Montreal, Quebec, Canada) during the period 2017-2019. Participants recorded an average total of 14,781 Ethica locations (standard deviation, 19,353) and 197,167 SenseDoc locations (standard deviation, 111,868). Dynamic time warping and cross-correlation were used to examine the spatial and temporal similarity of GPS points. Four activity-space measures derived from the smartphone app and the dedicated GPS device were compared. Analysis showed that cross-correlations were above 0.8 at the 125-m resolution for the survey and day levels and increased as cell size increased. At the day or survey level, there were only small differences between the activity-space measures. Based on our findings, we recommend dedicated GPS devices for studies where the exposure and the outcome are both measured at high frequency and when the analysis will not be aggregate. When the exposure and outcome are measured or will be aggregated to the day level, the dedicated GPS device and the smartphone app provide similar results.
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Aplicaciones Móviles , Teléfono Inteligente , Humanos , Sistemas de Información Geográfica , Encuestas y Cuestionarios , OntarioRESUMEN
Deep learning is a subfield of artificial intelligence and machine learning based mostly on neural networks and often combined with attention algorithms that has been used to detect and identify objects in text, audio, images, and video. Serghiou and Rough (Am J Epidemiol. 0000;000(00):0000-0000) present a primer for epidemiologists on deep learning models. These models provide substantial opportunities for epidemiologists to expand and amplify their research in both data collection and analyses by increasing the geographic reach of studies, including more research subjects, and working with large or high dimensional data. The tools for implementing deep learning methods are not quite yet as straightforward or ubiquitous for epidemiologists as traditional regression methods found in standard statistical software, but there are exciting opportunities for interdisciplinary collaboration with deep learning experts, just as epidemiologists have with statisticians, healthcare providers, urban planners, and other professionals. Despite the novelty of these methods, epidemiological principles of assessing bias, study design, interpretation and others still apply when implementing deep learning methods or assessing the findings of studies that have used them.
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In 2023, Martinez et al. examined trends in the inclusion, conceptualization, operationalization and analysis of race and ethnicity among studies published in US epidemiology journals. Based on a random sample of papers (N=1,050) published from 1995-2018, the authors describe the treatment of race, ethnicity, and ethnorace in the analytic sample (N=414, 39% of baseline sample) over time. Between 32% and 19% of studies in each time stratum lacked race data; 61% to 34% lacked ethnicity data. The review supplies stark evidence of the routine omission and variability of measures of race and ethnicity in epidemiologic research. Informed by public health critical race praxis (PHCRP), this commentary discusses the implications of four problems the findings suggest pervade epidemiology: 1) a general lack of clarity about what race and ethnicity are; 2) the limited use of critical race or other theory; 3) an ironic lack of rigor in measuring race and ethnicity; and, 4) the ordinariness of racism and white supremacy in epidemiology. The identified practices reflect neither current publication guidelines nor the state of the knowledge on race, ethnicity and racism; therefore, we conclude by offering recommendations to move epidemiology toward more rigorous research in an increasingly diverse society.
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INTRODUCTION: Structured data capture requires defined languages such as minimal Common Oncology Data Elements (mCODE). This pilot assessed the feasibility of capturing 5 mCODE categories (stage, disease status, performance status (PS), intent of therapy and intent to change therapy). METHODS: A tool (SmartPhrase) using existing and custom structured data elements was Built to capture 4 data categories (disease status, PS, intent of therapy and intent to change therapy) typically documented as free-text within notes. Existing functionality for stage was supported by the Build. Participant survey data, presence of data (per encounter), and time in chart were collected prior to go-live and repeat timepoints. The anticipated outcome was capture of >50% sustained over time without undue burden. RESULTS: Pre-intervention (5-weeks before go-live), participants had 1390 encounters (1207 patients). The median percent capture across all participants was 32% for stage; no structured data was available for other categories pre-intervention. During a 6-month pilot with 14 participants across three sites, 4995 encounters (3071 patients) occurred. The median percent capture across all participants and all post-intervention months increased to 64% for stage and 81%-82% for the other data categories post-intervention. No increase in participant time in chart was noted. Participants reported that data were meaningful to capture. CONCLUSIONS: Structured data can be captured (1) in real-time, (2) sustained over time without (3) undue provider burden using note-based tools. Our system is expanding the pilot, with integration of these data into clinical decision support, practice dashboards and potential for clinical trial matching.
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An integrated computer software system for macromolecular crystallography (MX) data collection at the BL02U1 and BL10U2 beamlines of the Shanghai Synchrotron Radiation Facility is described. The system, Finback, implements a set of features designed for the automated MX beamlines, and is marked with a user-friendly web-based graphical user interface (GUI) for interactive data collection. The Finback client GUI can run on modern browsers and has been developed using several modern web technologies including WebSocket, WebGL, WebWorker and WebAssembly. Finback supports multiple concurrent sessions, so on-site and remote users can access the beamline simultaneously. Finback also cooperates with the deployed experimental data and information management system, the relevant experimental parameters and results are automatically deposited to a database.
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The National Comprehensive Cancer Control Program, a Centers for Disease Control and Prevention funded program, supports cancer coalitions across the United States (US) in efforts to prevent and control cancer including development of comprehensive cancer control (CCC) plans. CCC plans often focus health equity within their priorities, but it is unclear to what extent lesbian, gay, bisexual, transgender, queer/questioning, plus (LGBTQ+) populations are considered in CCC plans. We qualitatively examined to what extent LGBTQ+ populations were referenced in 64 U.S. state, jurisdiction, tribes, and tribal organization CCC plans. A total of 55% of CCC plans mentioned LGBTQ+ populations, however, only one in three CCC plans mentioned any kind of LGBTQ+ inequity or LGBTQ+ specific recommendations. Even fewer plans included mention of LGBTQ+ specific resources, organizations, or citations. At the same time almost three fourths of plans conflated sex and gender throughout their CCC plans. The findings of this study highlight the lack of prioritization of LGBTQ+ populations in CCC plans broadly while highlighting exemplar plans that can serve as a roadmap to more inclusive future CCC plans. Comprehensive cancer control plans can serve as a key policy and advocacy structure to promote a focus on LGBTQ+ cancer prevention and control.
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To control human-to-human mpox transmission during the 2022 outbreak, European Union (EU)/European Economic Area (EEA) countries conducted case investigation and contact tracing (CT). We aimed to provide an overview of CT activities, describe CT data collection practices, and identify related facilitators, barriers, and potential opportunities for improvement. Between April 03, 2023 and May 12, 2023, a survey was distributed to CT stakeholders in 30 EU/EEA countries, asking about mpox CT activities and data collection and requesting to rank enablers, barriers, and improvements for CT on a five-point Likert scale. The 139 respondents from 27 countries indicated having performed case investigations (96%, n = 133), backward CT (88%, n = 122), forward CT (87%, n = 121), and follow-up on contacts' outcomes (77%, n = 107). Sixty percent (n = 80/134) used standardized data collection forms and 73% (n = 91/124) used databases. The highest-rated enablers were clear guidelines (mean = 3.9), quick access to laboratory results (3.6), and sufficient expertise (3.6). Highly rated barriers were inability to contact contacts (3.0) or cases (2.5) and lack of staff (2.4). The most needed improvements were availability of staff (3.5), expertise on affected populations (3.4) and data reporting tools and systems (3.3). To improve CT of mpox and diseases with similar transmission patterns, EU/EEA countries should increase workforce capacity in public and sexual health, offer training on CT operations and communication with affected communities, and use common CT data collection tools and systems.
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Trazado de Contacto , Mpox , Humanos , Unión Europea , Recolección de Datos , Brotes de Enfermedades/prevención & controlRESUMEN
BACKGROUND: People with dementia are routinely included as research participants in trials and other quantitative studies in which they are invited to respond to standardised measures. This paper reviews the reporting of standardised data collection from people with dementia in reports published in the National Institute for Health and Care Research (NIHR) Journals Library. The aim was to understand how the administration of standardised, self-report measures with people with dementia is reported in NIHR monographs and what could be learnt from this about the feasibility and acceptability of data collection approaches for future studies. METHODS: This was a systematic review with narrative synthesis. Broad search terms (Dementia OR Alzheimer*) were used to search the NIHR Journals Library website in December 2021. All studies that used (or intended to use) standardised measures to collect research data directly from people with dementia were eligible for inclusion. Information was extracted (where reported) on the process of data collection, dementia severity, levels of missing data and the experiences and reflections of those involved. RESULTS: Searches returned 42 records, from which 17 reports were assessed as eligible for inclusion, containing 22 studies. Response rates from participants with dementia in these studies varied considerably and appeared to be related to dementia severity and place of residence. Little information was reported on the process of data collection or the reasons for missing data, and most studies did not report the experiences of participants or those administering the measures. However, there was an indication from two studies that standardised data collection could provoke emotional distress in some participants with dementia. CONCLUSIONS: Through this review we identified both variation in levels of missing data and gaps in reporting which make it difficult to ascertain the reasons for this variation. We also identified potential risks to the well-being of participants with dementia which may be associated with the content of standardised measures and the context of data collection. Open reporting of and reflection upon data collection processes and the experiences of people involved is essential to ensure both the success of future data collection and the wellbeing of study participants. TRIAL REGISTRATION: Registered with Research on Research https://ror-hub.org/study/2905/ .
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Recolección de Datos , Demencia , Humanos , Demencia/psicología , Recolección de Datos/métodos , Recolección de Datos/normas , Recolección de Datos/estadística & datos numéricos , Narración , Autoinforme , Proyectos de Investigación/normasRESUMEN
Semantic relatedness and expectation were investigated in inattentional blindness-failure to perceive an unexpected object in plain sight when attention is engaged elsewhere. Participants named primary-task pictures and ignored distractor pictures. Four trials preceded a 'critical' trial where an unexpected six-letter-word appeared at fixation, simultaneously with the pictures. In Experiment 1, we found robust effects for both in-lab and on-line-Zoom methodology. More participants reported the unexpected word semantically-related to the primary-task pictures than a semantically-unrelated word. In Experiment 2, expectations were violated, by changing the semantic category of the primary-task pictures. More participants reported the unexpected word semantically-related to the unexpected picture category than a semantically-unrelated word. When attentional resources are consumed by a task, a violation to task expectations is not enough to reorient attention to an unexpected word. Attention reorients to what is meaningful to the task, and what is meaningful is updated in light of unexpected information.
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Atención , Semántica , Humanos , Atención/fisiología , Adulto , Adulto Joven , Masculino , Femenino , Reconocimiento Visual de Modelos/fisiología , Percepción Visual/fisiología , Anticipación Psicológica/fisiologíaRESUMEN
BACKGROUND: Despite a glaring need and proven efficacy, prospective surgical registries are lacking in low- and middle-income countries. The objective of this study was to design and implement a comprehensive prospective perioperative registry in a low-income country. METHODS: This study was conducted at Hawassa University Comprehensive Specialized Hospital in Hawassa, Ethiopia. Design of the registry occurred from June 2021 to May 2022 and pilot implementation from May 2022 to May 2023. All patients undergoing elective or emergent general surgery were included. Following one year, operability and fidelity of the registry were analyzed by assessing capture rate, incidence of missing data, and accuracy. RESULTS: A total of 67 variables were included in the registry including demographics, preoperative, operative, post-operative, and 30-day data. Of 440 eligible patients, 226 (51.4%) were successfully captured. Overall incidence of missing data and accuracy was 5.4% and 90.2% respectively. Post pilot modifications enhanced capture rate to 70.5% and further optimized data collection processes. CONCLUSION: The establishment of a low-cost electronic prospective perioperative registry in a low-income country represents a significant step forward in enhancing surgical care in under-resourced settings. The initial success of this registry highlights the feasibility of such endeavors when strong partnerships and local context are at the center of implementation. Continuous efforts to refine this registry are ongoing, which will ultimately lead to enhanced surgical quality, research output, and expansion to other sites.
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Mejoramiento de la Calidad , Sistema de Registros , Etiopía , Humanos , Estudios Prospectivos , Femenino , Masculino , Procedimientos Quirúrgicos Operativos/estadística & datos numéricos , Procedimientos Quirúrgicos Operativos/normas , Adulto , Persona de Mediana Edad , Países en Desarrollo , Proyectos Piloto , Atención Perioperativa/normasRESUMEN
While ample research has shown that sport injuries are associated with poor psychological status, scant attention has been given to changes in injured athletes' psychological status over the full course of recovery and return to sport. The aim of the present study was to prospectively investigate potential changes in injured athletes' psychological status across four phases of recovery and return to sport. A total of 38 severely injured adult competitive athletes (58% female; mean age 24.1 ± 7.18 years) participated in this prospective weekly investigation (n = 319 observations). Athletes' were asked to indicate their current phase of recovery or return to sport (acute care, rehabilitation, adapted training, or full return to sport) after which they responded to visual analog scales assessing post-injury psychological status, including: perceived pain (frequency and intensity), emotions (positive and negative), anxiety (cognitive and physiological), motivation, self-efficacy, and satisfaction. During the acute care phase, participants showed higher scores of perceived pain, and physiological anxiety compared to the other phases. During the adapted training phase, amotivation was higher than in the acute care phase, and self-efficacy was lower than in other phases. At full return to sport, athletes showed less perceived pain, cognitive anxiety, and more satisfaction than during other phases. The present study provides a deeper prospective understanding of changes in athlete's psychological status over the course of injury recovery and return to sport and highlight the importance of monitoring psychological status.
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Ansiedad , Traumatismos en Atletas , Volver al Deporte , Autoeficacia , Humanos , Femenino , Volver al Deporte/psicología , Estudios Prospectivos , Traumatismos en Atletas/psicología , Traumatismos en Atletas/rehabilitación , Masculino , Adulto , Adulto Joven , Ansiedad/psicología , Atletas/psicología , Motivación , Adolescente , Emociones , Satisfacción PersonalRESUMEN
BACKGROUND: Violence against women (VAW) research is a sensitive topic, which has been conducted mainly using face-to-face methods. The COVID-19 pandemic lockdown and restrictions on movement presented an opportunity to conduct VAW research using remote methods. We discuss how we adapted methods, reflect on lessons learned, and make recommendations highlighting key considerations when conducting remote research on a sensitive topic of VAW. METHODS: We designed and conducted an exploratory qualitative study using remote methods with 18 men and 19 women, aged 18 years and older, who lived with their partner or spouse during lockdown in South Africa. The aim of the study was to explore experiences of COVID-19 lockdown, and its link to women and children's experiences of violence in the homes. Data presented in this paper draws from researchers' reflections drawn from debriefing sessions during the research process, and from participants' interview transcripts. FINDINGS: Remote recruitment of participants took longer than anticipated, and we had to re-advertise the study. We could not ensure safety and privacy during interviews. Regardless of all the safety and privacy measures we put in place during the research process, some participants had an adult person present in the room during interviews, and the researchers had no control over interruptions. Rapport was difficult to establish without an in-person connection, which limited disclosure about violence experience (amongst women) and perpetration (amongst men). CONCLUSIONS: Given the methodological and ethical challenges which limited disclosure of VAW remotely, we conclude that telephone interviews used in our study impacted on the quality of study data. Therefore, we do not recommend VAW research to be conducted remotely, unless it is essential and participants are already known to the interviewer and trust has been established.
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COVID-19 , Violencia de Pareja , Adulto , Masculino , Niño , Humanos , Femenino , Sudáfrica/epidemiología , Pandemias , Control de Enfermedades Transmisibles , Violencia , Investigación CualitativaRESUMEN
CropLife Europe collected literature values from monitoring studies measuring air concentrations of Plant Protection Products (PPPs) that may be inhaled by humans located in rural areas but not immediately adjacent to PPP applications. The resulting "Combined Air Concentration Database" (CACD) was used to determine whether air concentrations of PPPs reported by the French "Agency for Food, Environmental and Occupational Health & Safety" (ANSES) are consistent with those measured by others to increase confidence in values of exposure to humans. The results were put into risk assessment context. Results show that 25-90% of samples do not contain measurable PPP concentrations. Measured respirable fractions were below EU default air concentrations used for risk assessment for resident exposure by the European Food Safety Authority. All measured exposures in the CACD were also below established toxicological endpoints, even when considering the highest maximum average reported concentrations and very conservative inhalation rates. The highest recorded air concentration was for prosulfocarb (0.696 µg/m³ measured over 48 h) which is below the EFSA default limit of 1 µg/m³ for low volatility substances. In conclusion, based on the CACD, measured air concentrations of PPPs are significantly lower than EFSA default limits and relevant toxicological reference values.
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Contaminantes Atmosféricos , Bases de Datos Factuales , Monitoreo del Ambiente , Medición de Riesgo , Humanos , Contaminantes Atmosféricos/análisis , Monitoreo del Ambiente/métodos , Exposición por Inhalación/análisis , Exposición por Inhalación/efectos adversosRESUMEN
BACKGROUND: Health outcomes are strongly impacted by social determinants of health, including social risk factors and patient demographics, due to structural inequities and discrimination. Primary care is viewed as a potential medical setting to assess and address individual health-related social needs and to collect detailed patient demographics to assess and advance health equity, but limited literature evaluates such processes. METHODS: We conducted an analysis of cross-sectional survey data collected from n = 507 Maryland Primary Care Program (MDPCP) practices through Care Transformation Requirements (CTR) reporting in 2022. Descriptive statistics were used to summarize practice responses on social needs screening and demographic data collection. A stepwise regression analysis was conducted to determine factors predicting screening of all vs. a targeted subset of beneficiaries for unmet social needs. RESULTS: Almost all practices (99%) reported conducting some form of social needs screening and demographic data collection. Practices reported variation in what screening tools or demographic questions were employed, frequency of screening, and how information was used. More than 75% of practices reported prioritizing transportation, food insecurity, housing instability, financial resource strain, and social isolation. CONCLUSIONS: Within the MDPCP program there was widespread implementation of social needs screenings and demographic data collection. However, there was room for additional supports in addressing some challenging social needs and increasing detailed demographics. Further research is needed to understand any adjustments to clinical care in response to identified social needs or application of data for uses such as assessing progress towards health equity and the subsequent impact on clinical care and health outcomes.
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Vivienda , Medicare , Anciano , Humanos , Estados Unidos , Maryland , Estudios Transversales , Atención Primaria de Salud , Recolección de DatosRESUMEN
Ethics in social science experimentation and data collection are often discussed but rarely articulated in writing as part of research outputs. Although papers typically reference human subjects research approvals from relevant institutional review boards, most recognize that such boards do not carry out comprehensive ethical assessments. We propose a structured ethics appendix to provide details on the following: policy equipoise, role of the researcher, potential harms to participants and nonparticipants, conflicts of interest, intellectual freedom, feedback to participants, and foreseeable misuse of research results. We discuss each of these and some of the norms and challenging situations of each. We believe that discussing such issues explicitly in appendices of papers, even if briefly, will serve two purposes: more complete communication of ethics can improve discussions of papers and can clarify and improve the norms themselves.
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Publicaciones/ética , Ciencias Sociales/ética , Comités de Ética en Investigación/ética , Ética en Investigación , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Investigadores/éticaRESUMEN
BACKGROUND: In-depth interviews are a common method of qualitative data collection, providing rich data on individuals' perceptions and behaviors that would be challenging to collect with quantitative methods. Researchers typically need to decide on sample size a priori. Although studies have assessed when saturation has been achieved, there is no agreement on the minimum number of interviews needed to achieve saturation. To date, most research on saturation has been based on in-person data collection. During the COVID-19 pandemic, web-based data collection became increasingly common, as traditional in-person data collection was possible. Researchers continue to use web-based data collection methods post the COVID-19 emergency, making it important to assess whether findings around saturation differ for in-person versus web-based interviews. OBJECTIVE: We aimed to identify the number of web-based interviews needed to achieve true code saturation or near code saturation. METHODS: The analyses for this study were based on data from 5 Food and Drug Administration-funded studies conducted through web-based platforms with patients with underlying medical conditions or with health care providers who provide primary or specialty care to patients. We extracted code- and interview-specific data and examined the data summaries to determine when true saturation or near saturation was reached. RESULTS: The sample size used in the 5 studies ranged from 30 to 70 interviews. True saturation was reached after 91% to 100% (n=30-67) of planned interviews, whereas near saturation was reached after 33% to 60% (n=15-23) of planned interviews. Studies that relied heavily on deductive coding and studies that had a more structured interview guide reached both true saturation and near saturation sooner. We also examined the types of codes applied after near saturation had been reached. In 4 of the 5 studies, most of these codes represented previously established core concepts or themes. Codes representing newly identified concepts, other or miscellaneous responses (eg, "in general"), uncertainty or confusion (eg, "don't know"), or categorization for analysis (eg, correct as compared with incorrect) were less commonly applied after near saturation had been reached. CONCLUSIONS: This study provides support that near saturation may be a sufficient measure to target and that conducting additional interviews after that point may result in diminishing returns. Factors to consider in determining how many interviews to conduct include the structure and type of questions included in the interview guide, the coding structure, and the population under study. Studies with less structured interview guides, studies that rely heavily on inductive coding and analytic techniques, and studies that include populations that may be less knowledgeable about the topics discussed may require a larger sample size to reach an acceptable level of saturation. Our findings also build on previous studies looking at saturation for in-person data collection conducted at a small number of sites.
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COVID-19 , Entrevistas como Asunto , Humanos , Tamaño de la Muestra , Entrevistas como Asunto/métodos , Investigación Cualitativa , SARS-CoV-2 , Pandemias , Recolección de Datos/métodos , InternetRESUMEN
BACKGROUND: The COVID-19 pandemic posed significant challenges to global health systems. Efficient public health responses required a rapid and secure collection of health data to improve the understanding of SARS-CoV-2 and examine the vaccine effectiveness (VE) and drug safety of the novel COVID-19 vaccines. OBJECTIVE: This study (COVID-19 study on vaccinated and unvaccinated subjects over 16 years; eCOV study) aims to (1) evaluate the real-world effectiveness of COVID-19 vaccines through a digital participatory surveillance tool and (2) assess the potential of self-reported data for monitoring key parameters of the COVID-19 pandemic in Germany. METHODS: Using a digital study web application, we collected self-reported data between May 1, 2021, and August 1, 2022, to assess VE, test positivity rates, COVID-19 incidence rates, and adverse events after COVID-19 vaccination. Our primary outcome measure was the VE of SARS-CoV-2 vaccines against laboratory-confirmed SARS-CoV-2 infection. The secondary outcome measures included VE against hospitalization and across different SARS-CoV-2 variants, adverse events after vaccination, and symptoms during infection. Logistic regression models adjusted for confounders were used to estimate VE 4 to 48 weeks after the primary vaccination series and after third-dose vaccination. Unvaccinated participants were compared with age- and gender-matched participants who had received 2 doses of BNT162b2 (Pfizer-BioNTech) and those who had received 3 doses of BNT162b2 and were not infected before the last vaccination. To assess the potential of self-reported digital data, the data were compared with official data from public health authorities. RESULTS: We enrolled 10,077 participants (aged ≥16 y) who contributed 44,786 tests and 5530 symptoms. In this young, primarily female, and digital-literate cohort, VE against infections of any severity waned from 91.2% (95% CI 70.4%-97.4%) at week 4 to 37.2% (95% CI 23.5%-48.5%) at week 48 after the second dose of BNT162b2. A third dose of BNT162b2 increased VE to 67.6% (95% CI 50.3%-78.8%) after 4 weeks. The low number of reported hospitalizations limited our ability to calculate VE against hospitalization. Adverse events after vaccination were consistent with previously published research. Seven-day incidences and test positivity rates reflected the course of the pandemic in Germany when compared with official numbers from the national infectious disease surveillance system. CONCLUSIONS: Our data indicate that COVID-19 vaccinations are safe and effective, and third-dose vaccinations partially restore protection against SARS-CoV-2 infection. The study showcased the successful use of a digital study web application for COVID-19 surveillance and continuous monitoring of VE in Germany, highlighting its potential to accelerate public health decision-making. Addressing biases in digital data collection is vital to ensure the accuracy and reliability of digital solutions as public health tools.
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Vacunas contra la COVID-19 , COVID-19 , SARS-CoV-2 , Humanos , Alemania/epidemiología , COVID-19/prevención & control , COVID-19/epidemiología , Estudios Prospectivos , Vacunas contra la COVID-19/administración & dosificación , Femenino , Masculino , Persona de Mediana Edad , Adulto , SARS-CoV-2/inmunología , Pandemias , Eficacia de las Vacunas/estadística & datos numéricos , Anciano , Internet , Autoinforme , Adulto Joven , Estudios de Cohortes , AdolescenteRESUMEN
BACKGROUND: The Network University Medicine projects are an important part of the German COVID-19 research infrastructure. They comprise 2 subprojects: COVID-19 Data Exchange (CODEX) and Coordination on Mobile Pandemic Apps Best Practice and Solution Sharing (COMPASS). CODEX provides a centralized and secure data storage platform for research data, whereas in COMPASS, expert panels were gathered to develop a reference app framework for capturing patient-reported outcomes (PROs) that can be used by any researcher. OBJECTIVE: Our study aims to integrate the data collected with the COMPASS reference app framework into the central CODEX platform, so that they can be used by secondary researchers. Although both projects used the Fast Healthcare Interoperability Resources (FHIR) standard, it was not used in a way that data could be shared directly. Given the short time frame and the parallel developments within the CODEX platform, a pragmatic and robust solution for an interface component was required. METHODS: We have developed a means to facilitate and promote the use of the German Corona Consensus (GECCO) data set, a core data set for COVID-19 research in Germany. In this way, we ensured semantic interoperability for the app-collected PRO data with the COMPASS app. We also developed an interface component to sustain syntactic interoperability. RESULTS: The use of different FHIR types by the COMPASS reference app framework (the general-purpose FHIR Questionnaire) and the CODEX platform (eg, Patient, Condition, and Observation) was found to be the most significant obstacle. Therefore, we developed an interface component that realigns the Questionnaire items with the corresponding items in the GECCO data set and provides the correct resources for the CODEX platform. We extended the existing COMPASS questionnaire editor with an import function for GECCO items, which also tags them for the interface component. This ensures syntactic interoperability and eases the reuse of the GECCO data set for researchers. CONCLUSIONS: This paper shows how PRO data, which are collected across various studies conducted by different researchers, can be captured in a research-compatible way. This means that the data can be shared with a central research infrastructure and be reused by other researchers to gain more insights about COVID-19 and its sequelae.