Electronic health records (EHRs) are increasingly recognized as a cost-effective resource for patient recruitment in clinical research. However, how to optimally select a cohort from millions of individuals to answer a scientific question of interest remains unclear. Consider a study to estimate the mean or mean difference of an expensive outcome. Inexpensive auxiliary covariates predictive of the outcome may often be available in patients\' health records, presenting an opportunity to recruit patients selectively, which may improve efficiency in downstream analyses. In this paper we propose a two-phase sampling design that leverages available information on auxiliary covariates in EHR data. A key challenge in using EHR data for multiphase sampling is the potential selection bias, because EHR data are not necessarily representative of the target population. Extending existing literature on two-phase sampling design, we derive an optimal two-phase sampling method that improves efficiency over random sampling while accounting for the potential selection bias in EHR data. We demonstrate the efficiency gain from our sampling design via simulation studies and an application evaluating the prevalence of hypertension among U.S. adults leveraging data from the Michigan Genomics Initiative, a longitudinal biorepository in Michigan Medicine.

UNASSIGNED: The survival rates of patients with nasopharyngeal carcinoma (NPC) have improved significantly, but there is no consensus on whether they can be considered cured. We aimed to determine whether a statistical cure could be achieved for patients with NPC in the contemporary therapeutic landscape.
UNASSIGNED: This retrospective multicenter study enrolled 6315 patients with nonmetastatic NPC from nonendemic and endemic regions of China from 2007 to 2020. We applied mixture and nonmixture cure models to estimate the cure probabilities and cure times by incorporating background mortality for the general population, matching by gender, age, and diagnosed year.
UNASSIGNED: With death as the uncured event, the probability of patients with NPC achieving a life expectancy at par with the general population was 78.1%. Considering progression as the uncured event, the likelihood of patients attaining a life expectancy without progression equivalent to that of the general population was 72.4%. For individuals, the probabilities of achieving cure were conditional and time-dependent, requiring approximately 7.1 and 4.7 years with 95% certainty, respectively. The corresponding cure times for uncured patients were 8.9 and 6.8 years, respectively. The cure probability was correlated with age, Eastern Cooperative Oncology Group score, TNM staging, Epstein-Barr virus DNA copies, and lactate dehydrogenase. The correlation was excellent between 5-year overall survival/progression-free survival and cure fractions.
UNASSIGNED: Statistical cure is potentially achievable among patients with NPC undergoing contemporary treatment modalities. The results hold significant potential implications for both clinical practice and patient perspectives.
UNASSIGNED: National High Level Hospital Clinical Research Funding; Beijing Xisike Clinical Oncology Research Foundation; Beijing hope run fund.

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) swept across the world in the waning months of 2019 and emerged as the cause of the coronavirus disease 19 (COVID-19) pandemic in early 2020. The use of convalescent plasma (CP) for prior respiratory pandemics provided a strong biological rationale for the rapid deployment of COVID-19 convalescent plasma (CCP) in early 2020 when no validated treatments or prior immunity existed. CCP is an antiviral agent, with its activity against SARS-CoV-2 stemming from specific antibodies elicited by the virus. Early efforts to investigate the efficacy of CCP in randomized clinical trials (RCTs) that targeted hospitalized patients with COVID-19 did not demonstrate the overall efficacy of CCP despite signals of benefit in certain subgroups, such as those treated earlier in disease. In contrast, studies adhering to the principles of antibody therapy in their study design, choice of patient population, and product qualification, i.e., those that administered high levels of specific antibody during the viral phase of disease in immunocompromised or very early in immunocompetent individuals, demonstrated benefits. In this chapter, we leverage the knowledge gained from clinical studies of CCP for COVID-19 to propose a framework for future studies of CP for a new infectious disease. This framework includes obtaining high-quality CP and designing clinical studies that adhere to the principles of antibody therapy to generate a robust evidence base for using CP.

UNASSIGNED: The Korean Journal of Family Medicine (KJFM), which is an official journal of the Korean Academy of Family Medicine, is an English-text medical journal published since 2009. Although nearly 15 years have passed since the journal was launched, to the best of our knowledge, no study has reviewed articles published in the KJFM. Accordingly, we analyzed articles published in the KJFM for the first time.
UNASSIGNED: Articles published in the KJFM between January 2018 and November 2023 were categorized according to article type. Information about author affiliations, study subjects, research methods, and modes of data collection was then scrutinized. Moreover, we compared the frequencies of subjects, research methods and modes of data collection before, during, and after the coronavirus disease 2019 pandemic.
UNASSIGNED: Original article was the most common article type. Approximately 52% of the articles were published by authors affiliated with departments other than family medicine, and 40% were published by family medicine. Approximately 60% and 38% of the articles were published by Korean authors and authors of international affiliations, respectively. Throughout the pandemic periods, research subjects focusing on \"diseases & symptoms\" have diminished, while \"principles of family medicine\" have progressively increased. Additionally, the use of cross-sectional study methods has declined. In terms of data collection, the use of \"big data,\" \"medical records,\" and \"questionnaires\" has decreased, whereas the use of \"study results\" has increased.
UNASSIGNED: KJFM is journal with wide and international participation covering various research subjects and study methods. We believe that our study provides valuable data for the future direction and development of the KJFM.

A successful clinical trial requires participants, but many factors can impede effective study recruitment. To better recruit for quality veterinary clinical trials in client-owned animals that lead to improved evidence-based patient care and outcomes, there is a collective need to share and implement current best practices for recruitment strategies. These strategies should utilize a holistic view of recruitment, encompassing study design and logistics, representative participation, incentives, personnel resources, advertising, and participant retention. Although human clinical trial data and resources can provide guidance, effort also needs to be put into evaluating current practices and opportunities for process improvement that are specific to the conduct of veterinary clinical trials. Considering the power of pets as naturally occurring models of disease and as sentinels, improved conduct of veterinary clinical research has the potential to inform human health outcomes. Continued development of collaborations surrounding best practices and training opportunities in veterinary clinical research will improve the impact of veterinary clinical trials teams, while also promoting workforce development and alternate career paths for veterinary professionals.

BACKGROUND: Research has established the effects of romantic relationships on individuals\' morbidity and mortality. However, the interplay between relationship functioning, affective processes, and health behaviors has been relatively understudied. During the COVID-19 pandemic, relational processes may influence novel health behaviors such as social distancing and masking.
OBJECTIVE: We describe the design, recruitment, and methods of the relationships, risk perceptions, and cancer-related behaviors during the COVID-19 pandemic study. This study was developed to understand how relational and affective processes influence romantic partners\' engagement in cancer prevention behaviors as well as health behaviors introduced or exacerbated by the COVID-19 pandemic.
METHODS: The relationships, risk perceptions, and cancer-related behaviors during the COVID-19 pandemic study used online survey methods to recruit and enroll 2 cohorts of individuals involved in cohabiting romantic relationships, including 1 cohort of dyads (n=223) and 1 cohort of cancer survivors (n=443). Survey assessments were completed over 2 time points that were 5.57 (SD 3.14) weeks apart on average. Health behaviors assessed included COVID-19 vaccination and social distancing, physical activity, diet, sleep, alcohol use, and smoking behavior. We also examined relationship factors, psychological distress, and household chaos.
RESULTS: Data collection occurred between October 2021 and August 2022. During that time, a total of 926 participants were enrolled, of which about two-thirds were from the United Kingdom (n=622, 67.8%) and one-third were from the United States (n=296, 32.2%); about two-thirds were married (n=608, 66.2%) and one-third were members of unmarried couples (n=294, 32%). In cohorts 1 and 2, the mean age was about 34 and 50, respectively. Out of 478 participants in cohort 1, 19 (4%) identified as Hispanic or Latino/a, 79 (17%) as non-Hispanic Asian, 40 (9%) as non-Hispanic Black or African American, and 306 (64%) as non-Hispanic White; 62 (13%) participants identified their sexual orientation as bisexual or pansexual, 359 (75.1%) as heterosexual or straight, and 53 (11%) as gay or lesbian. In cohort 2, out of 440 participants, 13 (3%) identified as Hispanic or Latino/a, 8 (2%) as non-Hispanic Asian, 5 (1%) as non-Hispanic Black or African American, and 398 (90.5%) as non-Hispanic White; 41 (9%) participants identified their sexual orientation as bisexual or pansexual, 384 (87.3%) as heterosexual or straight, and 13 (3%) as gay or lesbian. The overall enrollment rate for individuals was 66.14% and the overall completion rate was 80.08%.
CONCLUSIONS: We discuss best practices for collecting online survey data for studies examining relationships and health, challenges related to the COVID-19 pandemic, recruitment of underrepresented populations, and enrollment of dyads. Recommendations include conducting pilot studies, allowing for extra time in the data collection timeline for marginalized or underserved populations, surplus screening to account for expected attrition within dyads, as well as planning dyad-specific data quality checks.
UNASSIGNED: DERR1-10.2196/48516.

BACKGROUND: Designing effective health interventions and evaluating their impact is crucial to improving the health of the population. To ensure interventions are of high quality and effective, evidence-based research is essential, particularly studies that use randomised controlled trials (RCTs) or systematic reviews. However, RCTs may not be feasible or ethical in certain situations, such as in intensive care units. Cluster or stepped-wedge RCTs are alternative ways to assess interventions that also address these ethical concerns.
OBJECTIVE: To explain the stepped-wedge design and its main features as well as how to use it to evaluate nursing interventions.
CONCLUSIONS: Understanding stepped-wedge designs empowers nurses to implement evidence-based interventions and improve patient outcomes. The use of stepped-wedge designs has increased in nursing research over the past two decades, indicating growing recognition of its advantages: efficient evaluation of healthcare interventions, ensuring all clusters receive treatment over time; smaller sample sizes; ethical considerations; and time control. However, challenges remain: ensuring nurse researchers\' understanding and application of it is consistent, extended duration and logistical complexities. Methodological rigour, collaboration and understanding of secular trends are crucial, and nurses\' involvement in RCTs enhances cluster selection, data collection and dissemination.
CONCLUSIONS: The stepped-wedge design offers an ethical and adaptable method for studying interventions, considering healthcare complexities and allocating resources. Its versatility assists the advancement of nursing care delivery and in promoting evidence-based practice.
CONCLUSIONS: Understanding stepped-wedge designs in nursing practice enhances evidence-based care, decision-making, collaboration and professional development, benefiting patient outcomes.

While recognition of the link between physical activity and mental health dates back nearly two millennia, the academic study of physical activity is a relatively young discipline emerging over the last 50 years. This chapter provides an overview of key terms and measurement techniques in physical activity, exercise, and mental health research. The most common study designs in physical activity research include cross-sectional, cohort, randomized controlled trials, systematic reviews, and meta-analytic studies. Examples from the literature as well as the advantages and disadvantages of various methodological approaches are discussed throughout the chapter in the context of mental health research.