Sex contextualism in laboratory research: Enhancing rigor and precision in the study of sex-related variables.

Understanding sex-related variation in health and illness requires rigorous and precise approaches to revealing underlying mechanisms. A first step is to recognize that sex is not in and of itself a causal mechanism; rather, it is a classification system comprising a set of categories, usually assigned according to a range of varying traits. Moving beyond sex as a system of classification to working with concrete and measurable sex-related variables is necessary for precision. Whether and how these sex-related variables matter-and what patterns of difference they contribute to-will vary in context-specific ways. Second, when researchers incorporate these sex-related variables into research designs, rigorous analytical methods are needed to allow strongly supported conclusions. Third, the interpretation and reporting of sex-related variation require care to ensure that basic and preclinical research advance health equity for all.

An overview of real-world data sources for oncology and considerations for research.

Generating evidence on the use, effectiveness, and safety of new cancer therapies is a priority for researchers, health care providers, payers, and regulators given the rapid pace of change in cancer diagnosis and treatments. The use of real-world data (RWD) is integral to understanding the utilization patterns and outcomes of these new treatments among patients with cancer who are treated in clinical practice and community settings. An initial step in the use of RWD is careful study design to assess the suitability of an RWD source. This pivotal process can be guided by using a conceptual model that encourages predesign conceptualization. The primary types of RWD included are electronic health records, administrative claims data, cancer registries, and specialty data providers and networks. Careful consideration of each data type is necessary because they are collected for a specific purpose, capturing a set of data elements within a certain population for that purpose, and they vary by population coverage and longitudinality. In this review, the authors provide a high-level assessment of the strengths and limitations of each data category to inform data source selection appropriate to the study question. Overall, the development and accessibility of RWD sources for cancer research are rapidly increasing, and the use of these data requires careful consideration of composition and utility to assess important questions in understanding the use and effectiveness of new therapies.

Discordance in chromosomal and self-reported sex in the UK Biobank: Implications for transgender- and intersex-inclusive data collection.

There is growing need to distinguish between sex and gender. While sex is assigned at birth, gender is socially constructed and may not correspond to one's assigned sex. However, in most research studies, sex or gender is assessed in isolation or the terms are used interchangeably, which has implications for research accuracy and inclusivity. We used data from the UK Biobank to quantify the prevalence of disagreement between chromosomal and self-reported sex and identify potential reasons for discordance. Among approximately 200 individuals with sex discordance, 71% of discordances were potentially explained by the presence of intersex traits or transgender identity. The findings indicate that when describing sex- and/or gender-specific differences in health, researchers may be limited in their ability to draw conclusions regarding specific sex and/or gender health information.

A Review of Meta-Analyses in Plastic Surgery: Need for Adequate Assessment of Publication Bias.

INTRODUCTION: Publication bias describes a phenomenon in which significant positive results have a higher likelihood of being published compared to negative or nonsignificant results. Publication bias can confound the estimated therapeutic effect in meta-analyses and needs to be adequately assessed in the surgical literature. METHODS: A review of meta-analyses published in five plastic surgery journals from 2002 to 2022 was conducted. The inclusion criteria for meta-analyses were factors that demonstrated an obligation to assess publication bias, such as interventions with comparable treatment groups and enough power for statistical analysis. Acknowledgment of publication bias risk, quality of bias assessment, methods used in assessment, and individual article factors were analyzed. RESULTS: 318 unique meta-analyses were identified in literature search, and after full-text reviews, 143 met the inclusion criteria for obligation to assess publication bias. 64% of eligible meta-analyses acknowledged the confounding potential of publication bias, and only 46% conducted a formal assessment. Of those who conducted an assessment, 49% used subjective inspection of funnel plots alone, while 47% used any statistical testing in analysis. Overall, only 9/143 (6.3%) assessed publication bias and attempted to correct for its effect. Journals with a higher average impact factor were associated with mention and assessment of publication bias, but more recent publication year and higher number of primary articles analyzed were not. CONCLUSIONS: This review identified low rates of proper publication bias assessment in meta-analyses published in five major plastic surgery journals. Assessment of publication bias using objective statistical testing is necessary to ensure quality literature within surgical disciplines.

Recruiting people with selected citizenships for the health interview survey GEDA Fokus throughout Germany: evaluation of recruitment efforts and recommendations for future research.

BACKGROUND: Germany is the second most common country of immigration after the US. However, people with own or familial history of migration are not represented proportionately to the population within public health monitoring and reporting. To bridge this data gap and enable differentiated analyses on migration and health, we conducted the health interview survey GEDA Fokus among adults with Croatian, Italian, Polish, Syrian, or Turkish citizenship living throughout Germany. The aim of this paper is to evaluate the effects of recruitment efforts regarding participation and sample composition. METHODS: Data collection for this cross-sectional and multilingual survey took place between 11/2021 and 5/2022 utilizing a sequential mixed-mode design, including self-administered web- and paper-based questionnaires as well as face-to-face and telephone interviews. The gross sample (n = 33436; age range 18-79 years) was randomly drawn from the residents' registers in 120 primary sampling units based on citizenship. Outcome rates according to the American Association for Public Opinion Research, the sample composition throughout the multistage recruitment process, utilization of survey modes, and questionnaire languages are presented. RESULTS: Overall, 6038 persons participated, which corresponded to a response rate of 18.4% (range: 13.8% for Turkish citizenship to 23.9% for Syrian citizenship). Home visits accounted for the largest single increase in response. During recruitment, more female, older, as well as participants with lower levels of education and income took part in the survey. People with physical health problems and less favourable health behaviour more often took part in the survey at a later stage, while participants with symptoms of depression or anxiety more often participated early. Utilization of survey modes and questionnaire languages differed by sociodemographic and migration-related characteristics, e.g. participants aged 50 years and above more often used paper- than web-based questionnaires and those with a shorter duration of residence more often used a translated questionnaire. CONCLUSION: Multiple contact attempts, including home visits and different survey languages, as well as offering different modes of survey administration, increased response rates and most likely reduced non-response bias. In order to adequately represent and include the diversifying population in public health monitoring, national public health institutes should tailor survey designs to meet the needs of different population groups considered hard to survey to enable their survey participation.

Examining Concordance Between Self-Report and Biomedical HIV Viral Load Data: A Scoping Review.

Assessment of HIV viral load based on laboratory results is the gold standard in HIV care and research. However, blood assay or accessing medical records is not always possible due to research or service contexts and constraints. Self-report of viral load test results expands data resources, is a convenient method of collecting data in both research and service settings, and is useful for HIV surveillance. The purpose of this scoping review was to identify existing literature on the validity of self-reported viral load data compared to blood assay or medical record review. We found that the existing literature is limited, with varied data collection methods, self-report measures, and study designs, as well as predictors of accuracy. Concordance between self-reported viral load and biomedical data varied across studies but appeared to be more consistent among samples recruited from clinical populations that reported engagement in HIV care. While it is difficult to draw definitive conclusions about the validity of self-reported viral load across existing studies, there is a need for a standardized measure and method of collection that can be utilized across diverse populations living with HIV.

RESUMEN: La evaluación de la carga viral del VIH basada en resultados de laboratorio es el patrón-oro en la atención e investigación del VIH. Sin embargo, el análisis de sangre o el acceso a los registros médicos no siempre es posible debido a los contextos y limitaciones de la investigación o los servicios. El autoinforme de los resultados de las pruebas de carga viral aumenta los recursos de datos, es un método conveniente de recopilación de datos tanto en contextos de investigación como de servicios, y es útil para la vigilancia de VIH. El propósito de esta revisión de alcance fue identificar la literatura existente sobre la validez de los datos de carga viral autoinformados en comparación con análisis de sangre o revisión de registros médicos. Encontramos que la literatura existente es limitada, con variados métodos de recopilación de datos, medidas de autoinforme y diseños de estudio, así como predictores de exactitud. La concordancia entre la carga viral autoinformada y los datos biomédicos varió entre los estudios, pero pareció ser más consistente entre las muestras reclutadas de poblaciones clínicas que indicaron participación en la atención del VIH. Aunque es difícil extraer conclusiones definitivas sobre la validez de la carga viral autoinformada en los estudios existentes, existe la necesidad de una medida y un método de recopilación estandarizados que puedan utilizarse en diversas poblaciones que viven con el VIH.

How do dental practices respond to changes in scope of practice regulations?

Regulations that restrict the tasks that credentialed workers are allowed to perform may affect a firm's input choices, output, and which part of the market the firm serves. Using dental practice survey data from 1989 to 2014 and a stacked difference-in-differences design, this paper examines the effects of state-level scope of practice regulations on the behavior of dental practices. Results suggest that scope of practice deregulation in regards to dental hygienists' ability to administer nitrous oxide or local anesthesia is associated with fewer dentist visits per week in the short-term, lower patient wait times, and an increased likelihood of treating lower revenue generating publicly insured patients. There is weak evidence that scope of practice deregulation alters a practice's labor inputs.

Distinguishing Emotion Regulation Success in Daily Life From Maladaptive Regulation and Dysregulation.

ACADEMIC ABSTRACT: This paper aims to motivate research on emotion regulation success in naturalistic settings. We define emotion regulation success as achieving one's emotion regulation goal and differentiate it from related concepts (i.e., maladaptive regulation and dysregulation). As goals vary across individuals and situations, it is insufficient to conceptualize emotion regulation success as maximizing positive affect and minimizing negative affect. Instead, emotion regulation success can be measured through novel approaches targeting the achievement of emotion regulation goals. In addition to utilizing novel data analytic tools (e.g., response surface analyses), future research can make use of informant reports and observing ambulatory behavior or physiology. Considering emotion regulation goals when measuring daily emotion regulation success has the potential to answer key questions about personality, development, and mental health. PUBLIC ABSTRACT: People differ in how they want to feel in daily situations (e.g., excited) and why they want to feel that way (e.g., to make others feel better), depending on factors such as culture or age. Although people manage their emotions to reach these goals, most research assessing emotion regulation success has not taken individual goals into account. When assessing if people successfully regulate their emotions, most research in daily life has been focused on whether people feel more positive or less negative. To help study emotion regulation success in a more thoughtful and inclusive way, we propose a new approach to conceptualizing emotion regulation success that incorporates individual differences in what motivates people to regulate and discuss future research directions and applications.

Power to Detect What? Considerations for Planning and Evaluating Sample Size.

ACADEMIC ABSTRACT: In the wake of the replication crisis, social and personality psychologists have increased attention to power analysis and the adequacy of sample sizes. In this article, we analyze current controversies in this area, including choosing effect sizes, why and whether power analyses should be conducted on already-collected data, how to mitigate the negative effects of sample size criteria on specific kinds of research, and which power criterion to use. For novel research questions, we advocate that researchers base sample sizes on effects that are likely to be cost-effective for other people to implement (in applied settings) or to study (in basic research settings), given the limitations of interest-based minimums or field-wide effect sizes. We discuss two alternatives to power analysis, precision analysis and sequential analysis, and end with recommendations for improving the practices of researchers, reviewers, and journal editors in social-personality psychology. PUBLIC ABSTRACT: Recently, social-personality psychology has been criticized for basing some of its conclusions on studies with low numbers of participants. As a result, power analysis, a mathematical way to ensure that a study has enough participants to reliably "detect" a given size of psychological effect, has become popular. This article describes power analysis and discusses some controversies about it, including how researchers should derive assumptions about effect size, and how the requirements of power analysis can be applied without harming research on hard-to-reach and marginalized communities. For novel research questions, we advocate that researchers base sample sizes on effects that are likely to be cost-effective for other people to implement (in applied settings) or to study (in basic research settings). We discuss two alternatives to power analysis, precision analysis and sequential analysis, and end with recommendations for improving the practices of researchers, reviewers, and journal editors in social-personality psychology.

The Scientific Basis for the Regulation of Flavors in Tobacco Products.

Effective tobacco policies are important for reducing the harm of tobacco use and can have a broad impact at the population level. This review provides an overview of how clinical science can inform tobacco policies with a focus on policies related to flavored tobacco products, using menthol cigarettes as an illustrative example. Specifically, this review summarizes the role of flavors in tobacco use and the history of regulation of flavored tobacco products by the US Food and Drug Administration (FDA), provides an overview of clinical research methods used to contribute to the scientific evidence to inform FDA tobacco policies, discusses key findings related to menthol tobacco products using these methods, and proposes future directions for clinical research. As the tobacco marketplace continues to evolve with new products and flavor chemicals, ongoing clinical science will be essential for establishing evidence-based policies to protect public health and reduce tobacco-related health disparities.

Birthing a new maternal cognition literature: 10 recommendations for future research.

Whilst the field of maternal cognition is gaining interest, with a recent increase in publications, there are still only a handful of existing studies. This presents a unique opportunity for reflection and growth, advancing scientific rigor to ensure that future interpretations of maternal cognitive functioning are based on robust, generalizable data. With this in mind, we offer ten recommendations for future cognitive research in motherhood, with a focus on intentional study design. A study's design dictates the questions that can be asked, and the answers that can be gleaned from collected data, making study design a cornerstone of robust and reproducible science. These recommendations are intended as a resource for study conceptualization and design, participant recruitment, result interpretation, and peer review.

'Keeping it real': A qualitative exploration of preferences of people with lived experience for participation and active involvement in mental health research in Australia.

BACKGROUND: Historically, researchers have been apt at conducting research on, rather than with, the people who are the focus of their efforts. Such approaches often fail to effectively support and benefit the populations they are intended to. This study aimed to explore the preferences of people with lived experience for engagement with research either as research participants within studies, or through active involvement in mental health research. METHODS: Data for this paper were collected in three separate lived experience agenda-setting studies conducted over a 9-year period from 2013 to 2022; two group discussions and an open-ended online survey. Data were combined and thematic analysis undertaken. RESULTS: Participants described the inclusion of lived experience as a critical ingredient and the highest level of knowledge and expertise in mental health research that should lead to knowledge generation and research agendas. Participants discussed the importance and value of research that enables sharing experiences and stories, expressed a need for flexibility in research methods for choice and agency, and support for greater active involvement of people with lived experience across all stages of research. Participants also spoke to the need for perspective and knowledge generated from people with lived experience to have equal power in research, making space for lived experience voices across multiple aspects of research, and greater respect and recognition of the value of lived experience. CONCLUSION: Lived experience in mental health research is coming of age, but dedicated, cocreated development is needed to get it right. People with lived experience increasingly understand the value their experiential knowledge brings to the mental health research effort, and describe a wide range of ways that researchers can support them to be research participants, and to get actively involved. Power-sharing, respect and recognition of lived experience as central to effective mental health research are the keys to 'keeping it real'. PATIENT OR PUBLIC CONTRIBUTION: People with lived experience of mental health problems or distress either personally, and/or as carers, family and kinship group members, were involved in the coideation and codesign of this research. All authors identify as people with lived experience.

Unlocking gender dynamics in food and nutrition security in Ghana: assessing dietary diversity, food security, and crop diversification among cocoa household heads in the Juaboso-Bia cocoa landscape.

BACKGROUND: Malnutrition is a worldwide problem that impacts every country, affecting one in three individuals, including Ghana. According to estimates from the Food and Agriculture Organization (FAO), 690 million people were undernourished globally in 2019. Malnutrition is no exception in rural cocoa communities in Ghana. The expansion of cocoa is causing food insecurity and low dietary diversity in most cocoa-growing areas. There is little information on the food security status and dietary diversity among male-headed and female-headed cocoa households in the Juaboso-Bia cocoa landscape. Thus, this study sought to explore the dietary diversity distribution, food security status, sources of staple food, food unavailability periods, food production status, themes contributing to low dietary diversity and food insecurity, and perception of the impact of cocoa expansion on crop diversification among male-headed and female-headed cocoa households in the study area. METHODS: Both quantitative and qualitative research methods were employed to address the research questions. The study collected 200 semi-structured questionnaire data and 14 in-depth interview data from cocoa household heads in the Juaboso-Bia landscape. The survey data was cleaned and analysis, such as household dietary diversity status, food security status, and binary logistic regression were performed in the Statistical Package for Social Scientists (SPSS). The in-depth interviews were analyzed using thematic analysis. RESULTS: Through this study, it was revealed that 62.8% of the male-headed cocoa households had medium to high dietary diversity compared to their female counterparts 39.3%. About 47.9% of the male-headed households were food secure than the female-headed households (29.1%). Moreover, the months that both male and female-headed households recalled facing severe food unavailability were July and June. In addition, climate change/variability, unavailable lands, poverty, large household size, and gender stereotypes were themes promoting low dietary diversity and food insecurity among male and female-headed households. Furthermore, sex, total household income, and cropland conversion to cocoa were the variables influencing household heads' perception of the impact of cocoa expansion on crop diversification. CONCLUSIONS: The study showed that the male-headed cocoa households had high dietary diversity and were food secure than the female-headed cocoa households, lending credence to the conceptual framework applied in this study. There is a significant relationship between household head gender and food security status. Therefore, this study recommends the following interventions to improve dietary diversity and food security among male and female-headed cocoa households: raise awareness about the need for diverse diets and provide practical information on how to incorporate a greater variety of food groups into their daily meals; and promote gender equity and inclusivity in food security interventions. Future research could investigate how gender mainstreaming policies in agriculture have helped empower and improve the food security of female-headed households in Ghana.

Translational or translationable? A call for ethno-immersion in (empirical) bioethics research.

The shift towards "empirical bioethics" was largely triggered by a recognition that stakeholders' views and experiences are vital in ethical analysis where one hopes to produce practicable recommendations. Such perspectives can provide a rich resource in bioethics scholarship, perhaps challenging the researcher's perspective. However, overreliance on a picture painted by a group of research participants-or on pre-existing literature in that field-can lead to a biased view of a given context, as the subjectivity of data generated in these ways cannot (and should not wholly) be escaped. In response, we propose the implementation of a complementary approach of ethno-immersion in bioethics research. By positioning oneself in the context being researched, the researcher can better understand the realities of that context. The researcher's understanding will, naturally, be subjective too. However, it will act as a better developed and more informed outsider view, when considering the picture painted by participants and previous studies, thus enabling the researcher to introduce more nuance when analysing data. We introduce this approach after examining what we call the context detachment problem, whereby some bioethics scholarship-empirical or otherwise-fails to reflect the reality of the healthcare setting it concerns. Our proposed ethno-immersion (which differs from formal ethnography) is then explored as a response, highlighting its benefits, and answering the question of timing within a research project. Finally, we reflect on the applicability of our proposal to non-empirical bioethics scholarship, concluding that it remains important but may require some adjustments.

Evidence-based medicine or statistically manipulated medicine? Are we slaves to the P-value?

First popularized almost a century ago in epidemiologic research by Ronald Fisher and Jerzy Neyman, the P-value has become perhaps the most misunderstood and even misused statistical value or descriptor. Indeed, modern clinical research has now come to be centered around and guided by an arbitrary P-value of <0.05 as a magical threshold for significance, so much so that experimental design, reporting of experimental findings, and interpretation and adoption of such findings have become largely dependent on this "significant" P-value. This has given rise to multiple biases in the overall body of biomedical literature that threatens the very validity of clinical research. Ultimately, a drive toward reporting a "significant" P-value (by various statistical manipulations) risks creating a falsely positive body of science, leading to (i) wasted resources in pursuing fruitless research and (ii) futile or even harmful policies/therapeutic recommendations. This article reviews the history of the P-value, the conceptual basis of P-value in the context of hypothesis testing and challenges in critically appraising clinical evidence vis-à-vis the P-value. This review is aimed at raising awareness of the pitfalls of this rigid observation of the threshold of statistical significance when evaluating clinical trials and to generate discussion regarding whether the scientific body needs a rethink about how we decide clinical significance.

Dynamite plots in surgical research over 10 years: a meta-study using machine-learning analysis.

PURPOSE: Bar charts of numerical data, often known as dynamite plots, are unnecessary and misleading. Their tendency to alter the perception of mean's position through the within-the-bar bias and their lack of information on the distribution of the data are two of numerous reasons. The machine learning tool, Barzooka, can be used to rapidly screen for different graph types in journal articles.We aim to determine the proportion of original research articles using dynamite plots to visualize data, and whether there has been a change in their use over time. METHODS: Original research articles in nine surgical fields of research were sampled based on MeSH terms and then harvested using the Python-based biblio-glutton-harvester tool. After harvesting, they were analysed using Barzooka. Over 40 000 original research articles were included in the final analysis. The results were adjusted based on previous validation data with 95% confidence bounds. Kendall τ coefficient with the Mann-Kendall test for significance was used to determine the trend of dynamite plot use over time. RESULTS: Eight surgical fields of research showed a statistically significant decrease in use of dynamite plots over 10 years. Oral and maxillofacial surgery showed no significant trend in either direction. In 2022, use of dynamite plots, dependent on field and 95% confidence bounds, ranges from ~30% to 70%. CONCLUSION: Our results show that the use of dynamite plots in surgical research has decreased over time; however, use remains high. More must be done to understand this phenomenon and educate surgical researchers on data visualization practices.

Indigenous research methods for healing sexual trauma with Cree women.

In this study, exploratory research on self-determination using Indigenous research methods provided a model to help heal trauma and discuss recovery for traumatic sexual experiences. The methods and healing were based on a Cree worldview. Informed consent and questions were developed by the principal investigator prior to the research commencing. Eleven co-creators had the opportunity to revise questions, discuss the research, speak the Cree language, and participate in one-to-one interviews, group meetings and ceremonies. They also had the chance to review the transcripts and approve/disapprove the content, provide guidance on sacred knowledge and suggest terms to use, and co-author the paper, if they chose and three did. A Cree concept was developed from the work, namely, nehiyaw isecikewena which involved promoting self-determination and sovereignty alongside recovery.

Patients' and Clinicians' Perceptions of the Clinical Utility of Predictive Risk Models for Chemotherapy-Related Symptom Management: Qualitative Exploration Using Focus Groups and Interviews.

BACKGROUND: Interest in the application of predictive risk models (PRMs) in health care to identify people most likely to experience disease and treatment-related complications is increasing. In cancer care, these techniques are focused primarily on the prediction of survival or life-threatening toxicities (eg, febrile neutropenia). Fewer studies focus on the use of PRMs for symptoms or supportive care needs. The application of PRMs to chemotherapy-related symptoms (CRS) would enable earlier identification and initiation of prompt, personalized, and tailored interventions. While some PRMs exist for CRS, few were translated into clinical practice, and human factors associated with their use were not reported. OBJECTIVE: We aim to explore patients' and clinicians' perspectives of the utility and real-world application of PRMs to improve the management of CRS. METHODS: Focus groups (N=10) and interviews (N=5) were conducted with patients (N=28) and clinicians (N=26) across 5 European countries. Interactions were audio-recorded, transcribed verbatim, and analyzed thematically. RESULTS: Both clinicians and patients recognized the value of having individualized risk predictions for CRS and appreciated how this type of information would facilitate the provision of tailored preventative treatments or supportive care interactions. However, cautious and skeptical attitudes toward the use of PRMs in clinical care were noted by both groups, particularly in relationship to the uncertainty regarding how the information would be generated. Visualization and presentation of PRM information in a usable and useful format for both patients and clinicians was identified as a challenge to their successful implementation in clinical care. CONCLUSIONS: Findings from this study provide information on clinicians' and patients' perspectives on the clinical use of PRMs for the management of CRS. These international perspectives are important because they provide insight into the risks and benefits of using PRMs to evaluate CRS. In addition, they highlight the need to find ways to more effectively present and use this information in clinical practice. Further research that explores the best ways to incorporate this type of information while maintaining the human side of care is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT02356081; https://clinicaltrials.gov/study/NCT02356081.

Determining an Appropriate Sample Size for Qualitative Interviews to Achieve True and Near Code Saturation: Secondary Analysis of Data.

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.

Technical article: Overview of hospital-based data capture systems that acquire continuous ECG and physiologic data.

Data capture systems that acquire continuous hospital-based electrocardiographic (ECG) and physiologic (vital signs) data can foster robust research (i.e., large sample sizes from consecutive patients). However, the application of these systems and the data generated are complex and requires careful human oversight to ensure that accurate and high quality data are procured. This technical article will describe two different data capture systems created by our research group designed to examine false alarms associated with alarm fatigue in nurses. The following aspects regarding these data capture systems will be discussed: (1) history of development; (2) summary of advantages, challenges, and important considerations; (3) their use in research; (4) their use in clinical care; and (5) future developments.