ABSTRACT
OBJECTIVES: To explore whether UK primary care databases arising from two different software systems can be feasibly combined, by comparing rates of Huntington's disease (HD, which is rare) and 14 common cancers in the two databases, as well as characteristics of people with these conditions. DESIGN: Descriptive study. SETTING: Primary care electronic health records from Clinical Practice Research Datalink (CPRD) GOLD and CPRD Aurum databases, with linked hospital admission and death registration data. PARTICIPANTS: 4986 patients with HD and 1 294 819 with an incident cancer between 1990 and 2019. PRIMARY AND SECONDARY OUTCOME MEASURES: Incidence and prevalence of HD by calendar period, age group and region, and annual age-standardised incidence of 14 common cancers in each database, and in a subset of 'overlapping' practices which contributed to both databases. Characteristics of patients with HD or incident cancer: medical history, recent prescribing, healthcare contacts and database follow-up. RESULTS: Incidence and prevalence of HD were slightly higher in CPRD GOLD than CPRD Aurum, but with similar trends over time. Cancer incidence in the two databases differed between 1990 and 2000, but converged and was very similar thereafter. Participants in each database were most similar in terms of medical history (median standardised difference, MSD 0.03 (IQR 0.01-0.03)), recent prescribing (MSD 0.06 (0.03-0.10)) and demographics and general health variables (MSD 0.05 (0.01-0.09)). Larger differences were seen for healthcare contacts (MSD 0.27 (0.10-0.41)), and database follow-up (MSD 0.39 (0.19-0.56)). CONCLUSIONS: Differences in cancer incidence trends between 1990 and 2000 may relate to use of a practice-level data quality filter (the 'up-to-standard' date) in CPRD GOLD only. As well as the impact of data curation methods, differences in underlying data models can make it more challenging to define exactly equivalent clinical concepts in each database. Researchers should be aware of these potential sources of variability when planning combined database studies and interpreting results.
Subject(s)
Huntington Disease , Neoplasms , Humans , Huntington Disease/epidemiology , Electronic Health Records , Databases, Factual , Neoplasms/epidemiology , Primary Health Care , United Kingdom/epidemiologyABSTRACT
INTRODUCTION: Forensic nurses routinely provide services to sexual assault victims who are uncertain about reporting their assault to police. The purpose of this study was to determine whether assault characteristics are related to the concerns about police reporting expressed by sexual assault victims who have forensic evidence collected but do not report their assault to police at that time. METHODS: We analyzed medical records of patients who received services at a hospital-based forensic nursing program between 2010 and 2021. Records were included if a sexual assault evidence kit was collected, the patient declined to report the assault to police, and the patient completed a nonreport sexual assault evidence kit supplement form that included a question asking why they chose not to report the assault ( N = 296). We qualitatively analyzed patients' reasons for not reporting the assault and then used two-variable case-ordered matrices and chi-square analyses to explore relationships between reasons for not reporting and assault characteristics. RESULTS: Identified reasons for not reporting included lacking information about the assault, fear of harm/retaliation, and self-blame/minimization. Physical force, drug/alcohol consumption, and victim-offender relationship were related to patients referencing lacking information and fearing harm/retaliation as reasons for not reporting, but not related to the frequency of patients referencing self-blame/minimization. IMPLICATIONS: Results indicate that assault characteristics are related to reasons for not reporting at the time of the medical forensic examination. Being aware of these relationships may help forensic nurses provide patient-centered services and anticipatory guidance.
Subject(s)
Crime Victims , Forensic Nursing , Police , Sex Offenses , Humans , Female , Adult , Male , Middle Aged , Young Adult , AdolescentABSTRACT
After a sexual assault, survivors have the option of seeking a medical forensic exam, which includes medical evaluation and treatment, as well as forensic evidence collection. Forensic evidence is collected in a sexual assault evidence kit (SAEK) and typically released to police to aid in the investigation and potential prosecution of the assault. However, 20% to 25% of survivors who have a SAEK collected do not report their assault to police at that time and choose instead to have their SAEK stored for possible future use. This study sought to understand the reasons for not reporting among this group of survivors. We examined medical records of 296 individuals aged 18 and older who had documented their reasons for not reporting to police in their medical record and used a non-theory-driven coding framework to conduct a reflexive thematic analysis based on that data. We identified four themes: Reporting Won't Help, Reporting Will Harm, Not Now, and Not What I'm Here For. These data illustrate that survivors are making an active choice which, for many, was based on concerns that reporting would not meaningfully help their situation or may even make their situations worse. For some survivors, the decision to have forensic evidence collected without a police report was based on their needs at that moment, whereas for other survivors it was based on their desire to move on from the assault more permanently. Practice and policy recommendations are discussed, including the importance of providing survivors information about what police reporting would look like in specific circumstances as well as ensuring that financial concerns are not a barrier to survivors receiving post-assault medical care without forensic evidence collection.
Subject(s)
Crime Victims , Sex Offenses , Humans , Police , SurvivorsABSTRACT
In the United States, sexual assault survivors are advised to have a medical forensic exam and the collection of a sexual assault kit (SAK) to preserve biological evidence (e.g. semen, blood, saliva, hair) if they are considering reporting the assault to the police. Law enforcement personnel are supposed to submit the SAK (also known as a "rape kit") to a crime laboratory for forensic DNA testing, which can help identify or confirm the identity of the offender. However, police do not routinely submit SAKs for testing, and large stockpiles of untested kits have been found in police storage throughout the United States. Public outrage has prompted many cities to submit these older rape kits for DNA analysis, and this testing has identified thousands of suspected perpetrators. Police and prosecutors are re-opening these older sexual assault cases, which requires reestablishing contact with survivors who made the initial report years ago - a process referred to as "victim notification." In this study, we conducted qualitative interviews with survivors who received a SAK victim notification and participated in the re-investigation and prosecution of their cases. We explored how survivors reacted to this de facto admission of an institutional betrayal and the emotions they felt during and after the notification. Participants experienced considerable emotional distress (e.g. PTSD, anxiety, fear), anger and betrayal, and hope after they were recontacted by the police. Implications for making victim notifications more trauma informed are discussed.
Subject(s)
Crime Victims , Criminals , Rape , Sex Offenses , Humans , United States , Law Enforcement , Betrayal , Police , DNA , EmotionsABSTRACT
Current estimates suggest there are 300,000-400,000 untested sexual assault kits (SAKs) in police department storage facilities throughout the United States. As these kits are being discovered and then submitted for forensic DNA testing, legal system personnel may recontact victims. These "victim notifications" involve informing survivors their kits were previously untested, sharing the results of new DNA testing, and asking for their engagement in reinvestigating and prosecuting the case. Typically, victim notifications are conducted by police, and survivors are connected with victim advocates soon thereafter. In this study, we interviewed survivors about their experiences of being notified by the police. We also interviewed about their work supporting survivors. Both survivors and advocates expressed strong concerns about police conducting notifications without an advocate present.
Subject(s)
Crime Victims , Rape , Sex Offenses , Humans , United States , Law Enforcement/methods , Survivors , DNAABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic forced victim service organizations to establish new service provision protocols to include remote/telehealth services. We conducted N = 12 qualitative interviews with sexual assault advocates working in an urban agency in a predominately African American U.S. city to understand how they adapted services to meet the needs of their community. A thematic analysis revealed this organization was under-prepared for prolonged interruption of in-person services. Even though this agency was able to create telehealth options, many clients did not have the financial and technological resources to utilize these services. Advocates reported that survivors expressed a strong preference for in-person services, which afford more privacy and confidentiality. The pervasive digital divide within this urban community limited survivors' access to comprehensive services and jeopardized their safety.
Subject(s)
Community Health Services , Sex Offenses , Telemedicine , Humans , Black or African American , Confidentiality , COVID-19/therapy , Survivors , Urban Population , Community Health Services/methods , Community Health Services/organization & administrationABSTRACT
Intimate partner violence remains a significant public health issue and survivors often need various forms of support to achieve safety. The increased likelihood of experiencing housing instability and homelessness among survivors has led to an uptake in domestic violence agencies implementing housing-based interventions, such as Domestic Violence Housing First (DVHF), to address survivors' needs. The present study expands on prior research supporting the effectiveness of DVHF to examine situational factors that moderate the outcomes associated with this model among 406 survivors seeking services from domestic violence agencies located in the Pacific Northwestern region of the United States. Using latent profile analysis, participants were grouped into three latent classes: (a) "high abuse/instability," (b) "still affected," and (c) "doing better." Latent transition analysis was used to estimate the probability that participants would transition into a different latent class over time with social support (SS), material hardship, and receipt of DVHF services included as model predictors. Receipt of DVHF predicted improvements in survivors' safety, housing stability, mental health, and well-being, such that receiving DVHF was associated with higher odds of survivors transitioning into the "doing better" class. Social support and material hardship also emerged as significant factors predicting class membership, such that higher levels of social support and financial stability predicted membership in the "doing better" class. Additionally, social support and financial stability appeared to augment receipt of DVHF services, with DVHF being more strongly associated with positive outcomes among participants who also had high levels of social support and lower levels of material hardship. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Subject(s)
Domestic Violence , Housing , Intimate Partner Violence , Survivors , Domestic Violence/psychology , Survivors/psychology , Humans , Male , Female , Mental Health , Public Assistance , Social Support , Financial Stress , Intimate Partner Violence/psychology , Anxiety , Depression , Adult , Middle AgedABSTRACT
PURPOSE: Real-world data represents a valuable tool for pregnancy research. However, an algorithmic approach is needed to ascertain pregnancy timings from this complex data. The Clinical Practice Research Datalink (CPRD) GOLD Pregnancy Register, based on UK Primary care data, has therefore proven to be a valuable research tool. The same algorithmic approach was applied to the CPRD Aurum data to generate an equivalent register in the larger database. METHODS: Records of female patients registered with a CPRD Aurum contributing practice between the 1st of January 1987 and the 30th of April 2021 were searched for evidence of pregnancy. The algorithm used to generate the CPRD GOLD Pregnancy Register was redeveloped and applied first to CPRD GOLD and then to CPRD Aurum. The resulting CPRD Aurum Pregnancy Register was validated against the CPRD GOLD register, linked Hospital Episode Statistics (HES) and the Office of National Statistics (ONS) live birth data. RESULTS: There are 16 833 427 pregnancy episodes in the CPRD Aurum Pregnancy Register from 6 724 615 women, more than double the number in CPRD GOLD. The distribution of pregnancy outcome types was comparable between the registers. Across the whole register, there was good concordance between pregnancy episodes found in CPRD Aurum and linked HES. However, both CPRD registers saw a declining number of pregnancy episodes from 2007 onwards, steeper than in HES or the ONS birth data. CONCLUSIONS: A pregnancy register has been created in CPRD Aurum. Changes in antenatal care policies in the UK have led to declining numbers of pregnancies in EHR primary care data. However, the creation of this pregnancy register has tripled the number of patients in the CPRD Pregnancy Registers and will increase the capacity to study pregnancy in CPRD data, particularly rare or emerging exposures, and outcomes.
Subject(s)
Data Management , Pregnancy Outcome , Humans , Female , Pregnancy , Prenatal Care , Databases, Factual , Primary Health Care , United KingdomABSTRACT
This study examined how the COVID-19 pandemic affected sexual assault healthcare services in a predominately African American U.S. city. In mixed methods research design, we used quantitative interrupted time series modeling to evaluate changes in service rates for three core post-assault healthcare services-medical forensic exams (MFEs), medical advocacy MFE accompaniment, and counseling-from January 2019 through June 2021. We also conducted qualitative interviews with 12 sexual assault advocates to understand how their clients were impacted by COVID and how their agency adapted services to respond to the needs of their community. Both the quantitative and qualitative data revealed marked disruptions in service provision. The number of MFEs, medical advocacy accompaniments, and counseling sessions significantly decreased during the pandemic's initial surge, and survivors feared seeking hospital-based health care due to concerns that they might contract COVID-19 in hospital emergency departments. The number of MFEs performed by program staff did not return to pre-pandemic levels during this study's observation period, but the number of medical advocacy accompaniments and counseling sessions did significantly rebound. Counseling services eventually exceeded pre-pandemic levels as agency staff supported clients with both assault- and COVID-related trauma and loss. These results underscore the need for community-based sexual assault healthcare services, so that if public health emergencies limit the availability, accessibility, and safety of hospital emergency department care, sexual assault survivors have other settings for obtaining post-assault health care.
Subject(s)
COVID-19 , Crime Victims , Sex Offenses , Humans , Black or African American , Pandemics , Sex Offenses/psychology , Crime Victims/psychology , Survivors/psychology , Delivery of Health CareABSTRACT
OBJECTIVE: The open science movement seeks to make research more transparent, and to that end, researchers are increasingly expected or required to archive their data in national repositories. In qualitative trauma research, data sharing could compromise participants' safety, privacy, and confidentiality because narrative data can be more difficult to de-identify fully. There is little guidance in the traumatology literature regarding how to discuss data-sharing requirements with participants during the informed consent process. Within a larger research project in which we interviewed assault survivors, we developed and evaluated a protocol for informed consent for qualitative data sharing and engaging participants in data de-identification. METHOD: We conducted qualitative interviews with N = 32 adult sexual assault survivors regarding (a) how to conduct informed consent for data sharing, (b) whether participants should have input on sharing their data, and (c) whether they wanted to redact information from their transcripts prior to archiving. RESULTS: No potential participants declined participation after learning about the archiving mandate. Survivors indicated that they wanted input on archiving because the interview is their story of trauma and abuse and it would be disempowering not to have control over how this information was shared and disseminated. Survivors also wanted input on this process to help guard their privacy, confidentiality, and safety. None of the participants elected to redact substantive data prior to archiving. CONCLUSIONS: Engaging participants in the archiving process is a feasible practice that is important and empowering for trauma survivors. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Subject(s)
Confidentiality , Sex Offenses , Adult , Humans , Informed Consent , Surveys and Questionnaires , Qualitative Research , Information DisseminationABSTRACT
Research studies have identified multiple study- and sample-related factors that predict variation in the proportion of participants who report experiences of rape (non-consensual oral, anal, or vaginal penetration obtained by force, threat of force, and/or victim incapacitation). The magnitude of variation introduced by these methodological variables is often unclear, which can complicate attempts to compare findings across research studies. With the goal of identifying and quantifying sources of variation, we conducted a meta-analysis that compared rates of rape experienced by women in the United States during adolescence or adulthood. 6391 research articles were evaluated for inclusion and 84 studies (89 independent samples) met inclusion criteria. Results of a random-effects meta-analysis found that an average of 17.0 % (95 % CI [15.7 %, 18.3 %]) of participants across samples reported experiences of rape in adolescence or adulthood. The mean participant age, source of the sample, perpetration tactics included in the measure, and interaction between sample source and perpetration tactics each predicted significant variation in the proportion of victims identified. Participant recruitment method, publication year, and the earliest age included in the reference period did not predict significant variation. These findings clarify the impact of methodological variables on observed victimization rates and provide context that can inform comparisons across sexual victimization studies.
ABSTRACT
OBJECTIVE: To compare patient-reported anxiety, depression and quality-of-life (QoL) outcomes, with data registered in patients' primary care electronic health record (EHR). DESIGN: Cross-sectional study. SETTING: Primary care in the UK. PARTICIPANTS: A convenience sample of 608 women registered in the Clinical Practice Research Datalink GOLD primary care database (data from a previous study on 356 breast cancer survivors (8.1 years postdiagnosis) and 252 women with no prior cancer). OUTCOME MEASURES: Patient-reported data on anxiety, depression and QoL, collected through postal questionnaires, and compared with coded information in EHR up to 2 years prior. RESULTS: Abnormal anxiety symptoms were reported by 118 of 599 women who answered the relevant questions (21%); 59/118 (50%) had general practitioner (GP)-recorded anxiolytic/antidepressant use, and 2 (1.6%) had anxiety coded in the EHR. 26/601 women (11%) reported depression symptoms, of whom 17 (65.4%) had GP-recorded antidepressant use and none had depression coded. 65 of 123 women reporting distress on the pain QoL domain (52.8%) had a corresponding record in the EHR <3 months before and 92 (74.8%) <24 months before. No patients reporting fatigue (n=157), sexual health problems (156), social avoidance (82) or cognitive problems (93) had corresponding codes in the EHR. There were no meaningful differences in the concordance results between breast cancer survivors and women with no history of cancer. CONCLUSION: Many patients reporting mental health and QoL problems had no record of this in coded primary care data. This finding suggests that coded data does not fully reflect the burden of disease. Further research is needed to understand whether or not GPs are aware of patient distress in cases where codes have not been recorded.
Subject(s)
Breast Neoplasms , Quality of Life , Humans , Female , Depression/epidemiology , Mental Health , Cross-Sectional Studies , Anxiety/epidemiology , Antidepressive Agents , Primary Health Care , United Kingdom/epidemiologyABSTRACT
INTRODUCTION: The COVID-19 pandemic has led to concerns about potential adverse pregnancy outcomes associated with infection, resulting in intensive research. Numerous studies have attempted to examine whether COVID-19 is associated with an increased risk of pregnancy loss. However, studies and reviews to date have drawn differing conclusions. The aim of this systematic review is to provide a summary of all quantitative research on the relationship between pregnancy loss and COVID-19 infection and, if appropriate, to synthesise the evidence into an overall effect estimate. METHODS AND ANALYSIS: Three publication databases (Embase, PubMed and Cochrane) and four preprint databases (medRxiv, Lancet Preprint, Gates Open Research and Wellcome Open Research) will be searched. Boolean logic will be used to combine terms associated with pregnancy loss and COVID-19. The population of interest are pregnant women. Retrieved results will be assessed in two phases: (1) abstract screening and (2) full text evaluation. All studies which compare pregnancy loss outcomes in women who had COVID-19 versus those who did not quantitatively will be included. Narrative and non-English studies will be excluded. Two reviewers will screen independently, with results compared and discrepancies resolved by the study team. Study quality and risk of bias will be assessed using a quality appraisal tool. Results will be summarised descriptively and where possible synthesised in a meta-analysis. ETHICS AND DISSEMINATION: This systematic review requires no ethical approval. This review will be published in a peer-reviewed journal and provide an important update in a rapidly evolving field of research. PROSPERO REGISTRATION NUMBER: CRD42022327437.
Subject(s)
Abortion, Spontaneous , COVID-19 , Abortion, Spontaneous/epidemiology , COVID-19/epidemiology , Female , Humans , Meta-Analysis as Topic , Pandemics , Pregnancy , Pregnancy Outcome/epidemiology , Research Design , Stillbirth/epidemiology , Systematic Reviews as TopicSubject(s)
Advance Care Planning , Aged , Documentation , Hospitals , Humans , Residential FacilitiesABSTRACT
OBJECTIVE: The aim of this study was to identify latent classes of posttraumatic stress disorder (PTSD) symptoms in a community sample of sexual assault survivors whose assaults occurred varying lengths of time in the past and to explore patterns of transition between those latent classes over time. METHOD: Latent class analysis was used to identify naturally occurring subgroups of PTSD symptoms in a sample of sexual assault survivors who completed two mailed surveys 1 year apart (N = 1,271). Latent transition analysis was then used to examine individuals' probabilities of transitioning into each latent class at Time 2 based on their latent class membership at Time 1. RESULTS: A four-class model emerged as the best fitting model at both Time 1 and Time 2. Classes demonstrated overall severity and symptom cluster severity differences. Transition into a lower severity class was more common than transition into a higher severity class, though escalation was demonstrated by 6-20% of participants in each latent class. CONCLUSIONS: The substantial heterogeneity in sexual assault survivors' PTSD symptoms highlights the variety of ways that posttraumatic stress may be experienced years after a sexual assault. Future research should explore factors that affect long-term symptoms, including cumulative lifetime trauma and social support. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
ABSTRACT
Traditional and more modern conceptualizations of psychopathy cite problems with impulse control. However, the extent to which these problems represent a cardinal feature of the disorder has been debated. In this study, we conducted a preregistered systematic review and meta-analysis, searching Embase, Medline, PsycINFO, and PubMed, for studies from inception to January 6th, 2022. We included 21 studies, published between 2009 and 2021, that reported on the relationship of psychopathy with performance on the go/no-go or stop signal task. A multilevel random-effects meta-analysis, including 43 effect sizes from 17 studies (total N = 1394), showed a significant pooled association between psychopathy and response inhibition r = -0.143 (95 % CI: -0.250 to -0.034). The relatively small effect size, although statistically significant, calls in to question the extent to which difficulties in response inhibition should be considered a cardinal feature of psychopathic personality. The strength of the relationship did not significantly differ between non-criminal and criminal samples, gender, task type, tasks with or without an affective component, or by psychopathy trait dimension.
Subject(s)
Antisocial Personality Disorder , Task Performance and Analysis , Humans , Antisocial Personality Disorder/psychologyABSTRACT
The impact of influenza and pneumonia on individuals in clinical risk groups in England has not previously been well characterized. Using nationally representative linked databases (Clinical Practice Research Database (CPRD), Hospital Episode Statistics (HES) and Office for National Statistics (ONS)), we conducted a retrospective cohort study among adults (≥ 18 years) during the 2010/2011-2019/2020 influenza seasons to estimate the incidence of influenza- and pneumonia-diagnosed medical events (general practitioner (GP) diagnoses, hospitalisations and deaths), stratified by age and risk conditions. The study population included a seasonal average of 7.2 million individuals; approximately 32% had ≥1 risk condition, 42% of whom received seasonal influenza vaccines. Medical event incidence rates increased with age, with ~1% of adults aged ≥75 years hospitalized for influenza/pneumonia annually. Among individuals with vs. without risk conditions, GP diagnoses occurred 2-5-fold more frequently and hospitalisations were 7-10-fold more common. Among those with obesity, respiratory, kidney or cardiovascular disorders, hospitalisation were 5-40-fold more common than in individuals with no risk conditions. Though these findings likely underestimate the full burden of influenza, they emphasize the concentration of disease burden in specific age and risk groups and support existing recommendations for influenza vaccination.
Subject(s)
Influenza Vaccines , Influenza, Human , Pneumonia , Adult , Aged , England/epidemiology , Humans , Influenza, Human/prevention & control , Pneumonia/epidemiology , Pneumonia/prevention & control , Retrospective StudiesABSTRACT
BACKGROUND: Although primary care is a well suited context for conducting advance care planning (ACP), there are many barriers to initiating discussions regarding future health preference and end-of-life conversations. METHODS: This qualitative study conducted 30 detailed individual interviews with senior administrators, medical and nurse practitioners of a local health district, NSW Ambulance, e-Health NSW, general practitioners and practice nurses to find out about barriers to ACP in South Western Sydney. RESULTS: Thematic analysis was conducted on the interviews. Six major themes were identified: Prevalence; Empowerment of roles and responsibilities; Lack of training/knowledge/confidence; Fragmentation of care; Patient/family readiness; and Prognostication. Half of the participants were willing to use a prognostic tool to identify when a patient was likely to be at the end of their life and provide a prompt to initiate ACP. CONCLUSION: In addition to addressing training and acknowledging resource constraints, these findings suggest that if a prognostic tool was validated and practical in a primary care setting, it may provide valuable assistance to encourage everyone in society to begin discussing this issue and completing ACP.
Subject(s)
Advance Care Planning , General Practitioners , Communication , Humans , Primary Health Care , Qualitative ResearchABSTRACT
Sexual assault advocates provide support to survivors as they navigate medical, legal, housing, and other complex systems. However, social distancing measures enacted in response to coronavirus disease 2019 (COVID-19) forced changes to traditional advocacy services. The current study aimed to understand how the COVID-19 pandemic transformed survivors' engagement with sexual assault advocacy services. Semi-structured interviews were conducted with 12 sexual assault advocates from a community-based advocacy organization in Detroit. Thematic analysis was employed to uncover emergent themes reflecting COVID-19's impact on survivors' engagement with advocacy services. Three themes were identified: (1) Disruption to advocacy services; (2) difficulty obtaining tangible resources; and (3) desire for COVID-related support, information, and resources. This study highlights the needs of sexual assault survivors during the COVID-19 pandemic and explores how public health emergencies have the potential to exacerbate the needs of this vulnerable population. Implications and future directions for service provision and research are considered.
Subject(s)
COVID-19 , Sex Offenses , Humans , Pandemics , SurvivorsABSTRACT
We estimated the frequency of non-specific influenza-associated clinical endpoints to inform the feasibility of pragmatic randomized controlled trials (RCT) assessing relative vaccine effectiveness (rVE). Hospitalization rates of respiratory, cardiovascular and diabetic events were estimated from Denmark and England's electronic databases and stratified by age, comorbidity and influenza vaccination status. We included a seasonal average of 4.5 million Danish and 7.2 million English individuals, 17 and 32% with comorbidities. Annually, approximately 1% of Danish and 0.5% of English individuals were hospitalized for selected events, ~50% of them respiratory. Hospitalization rates were 40-50-fold and 2-10-fold higher in those >50 years and with comorbidities, respectively. Our findings suggest that a pragmatic RCT using non-specific endpoints is feasible. However, for outcomes with rates <2.5%, it would require randomization of ~100,000 participants to have the power to detect a rVE difference of ~13%. Targeting selected groups (older adults, those with comorbidities) where frequency of events is high would improve trial efficiency.