Scientific guidelines for evaluating the validity of forensic feature-comparison methods.

When it comes to questions of fact in a legal context-particularly questions about measurement, association, and causality-courts should employ ordinary standards of applied science. Applied sciences generally develop along a path that proceeds from a basic scientific discovery about some natural process to the formation of a theory of how the process works and what causes it to fail, to the development of an invention intended to assess, repair, or improve the process, to the specification of predictions of the instrument's actions and, finally, empirical validation to determine that the instrument achieves the intended effect. These elements are salient and deeply embedded in the cultures of the applied sciences of medicine and engineering, both of which primarily grew from basic sciences. However, the inventions that underlie most forensic science disciplines have few roots in basic science, and they do not have sound theories to justify their predicted actions or results of empirical tests to prove that they work as advertised. Inspired by the "Bradford Hill Guidelines"-the dominant framework for causal inference in epidemiology-we set forth four guidelines that can be used to establish the validity of forensic comparison methods generally. This framework is not intended as a checklist establishing a threshold of minimum validity, as no magic formula determines when particular disciplines or hypotheses have passed a necessary threshold. We illustrate how these guidelines can be applied by considering the discipline of firearm and tool mark examination.

Distribution of rapid HCV antibody self-test kits via needle/syringe dispensing machines: Implementation and evaluation of the Vend-C pilot study in Melbourne, Australia.

Recent guidance from the World Health Organization strongly recommended hepatitis C virus (HCV) self-testing. We implemented the Vend-C pilot study to explore the effectiveness and feasibility of distributing rapid HCV antibody self-test kits to people who inject drugs via needle/syringe dispensing machines (SDMs). Over a 51-day study period between August and September 2022, we distributed HCV antibody self-test kits via two SDMs. During the study period, 63 self-test kits were dispensed, averaging 1.2 self-test kits per day. Our access methods for evaluation questionnaires failed to attract participants (n = 4). We implemented the Vend-C pilot study in direct response to recent WHO recommendations. While self-test kits were effectively distributed from the two SDMs, our evaluation methodology failed. Consequently, we cannot determine the success of linkage to care. Even so, with HCV treatment numbers dropping in Australia, innovative engagement solutions are needed, and considering the number of self-test kits provided in our pilot, the model could have an important future place in HCV elimination efforts.

Neighborhood ethnic density and disparities in proximal blood donation opportunities.

BACKGROUND: Despite being the largest racial/ethnic minority group in the United States, Hispanic/Latinos (H/L) are significantly underrepresented among blood donors. A lack of proximal blood donation opportunities may be one factor contributing to these disparities. However, few studies have investigated this possibility. STUDY DESIGN AND METHODS: Proprietary data on mobile blood collections in Maricopa County, Arizona, were gathered for the period of January 01, 2022 to April 30, 2022 and paired with census tract information using ArcGIS. Maricopa County encompasses the city of Phoenix with a total population of approximately 4.5 million people, including 1.5 million H/L residents. Blood drive count was regressed on H/L ethnic density and total population, and model estimates were exponentiated to obtain odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: During the specified period, approximately 27,000 red blood cell units were collected through mobile drives. Consistent with expectations, when controlling for total neighborhood population, each 10% increase in H/L ethnic density lowered the odds of having a blood drive in the corresponding neighborhood by 12% (OR = 0.88, 95% CI (0.83, 0.92), p < .001). DISCUSSION: These findings provide initial evidence of fewer proximal donation opportunities in areas with greater H/L population density which may contribute to H/L underrepresentation in blood donation and the need for more inclusive collection efforts. Improved access to blood collection is modifiable and could help to increase the overall blood supply, enhance the ability to successfully match specific blood antigen needs of an increasingly diverse population, and bring about a more resilient blood system.

Opportunities to improve feedback to reduce blood component wastage: Results of a national scheme evaluation.

BACKGROUND: Blood components are costly and scarce. The Blood Stocks Management Scheme (BSMS) was established in the United Kingdom (UK) to support hospital transfusion services and national blood services through collection, analysis, and monthly feedback of data on blood component inventory and wastage management. There is a growing evidence base on how best to deliver feedback for quality improvement. We assessed the quality and utility of the monthly BSMS component reports. METHODS: We assessed the content of BSMS reports issued in March 2023 against established criteria for effective feedback. Two researchers independently rated whether criteria spanning the five domains of goal setting, data collection, feedback content, feedback display and feedback delivery were fully, partially or not met. Disagreements were resolved through discussion. We conducted an online questionnaire survey of recipients of BSMS reports during March 2023 to assess their use of reports and seek suggestions for improvement. RESULTS: Five out of 20 criteria for effective feedback were fully met. Areas for improvement included placing more emphasis in the feedback on positive change, linking data and summary messages, and including specific suggestions for action. Respondents highlighted the value of benchmarked comparisons with other hospital transfusion services. CONCLUSION: There is scope for enhancing the effectiveness and utility of BSMS feedback reports and hence reducing wastage of blood components. This methodology for evaluation of feedback could be utilized to improve other areas of transfusion practice.

How do we achieve blinding in modern electronic and paper medical records during the conduct of transfusion trials?

BACKGROUND: Regulatory aspects of transfusion medicine add complexity in blinded transfusion trials when considering various electronic record keeping software and blood administration processes. The aim of this study is to explore strategies when blinding transfusion components and products in paper and electronic medical records. METHODS: Surveys were collected and interviews were conducted for 18 sites across various jurisdictions in North America to determine solutions applied in previous transfusion randomized control trials. RESULTS: Sixteen responses were collected of which 11 had previously participated in a transfusion randomized control trial. Various solutions were reported which were specific to the laboratory information system (LIS) and electronic medical record (EMR) combinations although solutions could be grouped into four categories which included the creation of a study product code in the LIS, preventing the transmission of data from the LIS to the EMR, utilizing specialized stickers and labels to conceal product containers and documents in the paper records, and modified bedside procedures and documentation. DISCUSSION: LIS and EMR combinations varied across sites, so it was not possible to determine combination-specific solutions. The study was able to highlight solutions that may be emphasized in future iterations of LIS and EMR software as well as procedural changes that may minimize the risk of unblinding.

Patient and caregiver perceptions of the possibility of home blood transfusions.

BACKGROUND: Patients with hematologic malignancies (HM) often develop transfusion dependence. The patient and caregiver burdens associated with the need for frequent transfusions are high. Home blood transfusions has the potential to reduce these burdens, but is not widely practiced in the United States. We designed a qualitative study to evaluate the patient and caregiver perceptions of the potential for a home blood transfusion program. STUDY DESIGN AND METHODS: Eligible patients included Adult (≥18 years) patients who were English speaking and met the definition for transfusion dependence within 3 months of study enrollment. We identified and interviewed eligible participants (patients and caregivers), using a semi-structured interview guide to elicit patient perceptions of the acceptability, barriers, and benefits related to home blood product transfusions. Interviews were audio recorded and transcribed. Results were imported into NVivo 12 (version 12; QSR International, Burlington, VT) for coding and analysis. RESULTS: We recruited participants until we reached thematic saturation, which occurred at 29 participants (20 patients, 9 caregivers). Among the 20 patient participants, nine had MDS (45%) and 11 had acute leukemia (55%). Most of the patients (60%) reported getting one transfusion per week. Four themes emerged when the participants discussed their perception regarding the potential of a home blood transfusion program: (1) current in-person experience, (2) caregiver burden, (3) perceptions of home blood transfusions, and (4) interest in participating in a home blood transfusion program. CONCLUSION: The concept of home blood transfusions was well received and further research to study its implementation is warranted.

Assessing cardiovascular disease risk in women with a history of hypertensive disorders of pregnancy: A guidance paper for studies using administrative data.

BACKGROUND: Hypertensive disorders of pregnancy (HDP) are a major cause of maternal morbidity and mortality, and their association with increased cardiovascular disease (CVD) risk represents a major public health concern. However, assessing CVD risk in women with a history of these conditions presents unique challenges, especially when studies are carried out using routinely collected data. OBJECTIVES: To summarise and describe key challenges related to the design and conduct of administrative studies assessing CVD risk in women with a history of HDP and provide concrete recommendations for addressing them in future research. METHODS: This is a methodological guidance paper. RESULTS: Several conceptual and methodological factors related to the data-generating mechanism and study conceptualisation, design/data management and analysis, as well as the interpretation and reporting of study findings should be considered and addressed when designing and carrying out administrative studies on this topic. Researchers should develop an a priori conceptual framework within which the research question is articulated, important study variables are identified and their interrelationships are carefully considered. CONCLUSIONS: To advance our understanding of CVD risk in women with a history of HDP, future studies should carefully consider and address the conceptual and methodological considerations outlined in this guidance paper. In highlighting these challenges, and providing specific recommendations for how to address them, our goal is to improve the quality of research carried out on this topic.

Transforming research to improve therapies for trauma in the twenty-first century.

Improvements have been made in optimizing initial care of trauma patients, both in prehospital systems as well as in the emergency department, and these have also favorably affected longer term outcomes. However, as specific treatments for bleeding are largely lacking, many patients continue to die from hemorrhage. Also, major knowledge gaps remain on the impact of tissue injury on the host immune and coagulation response, which hampers the development of interventions to treat or prevent organ failure, thrombosis, infections or other complications of trauma. Thereby, trauma remains a challenge for intensivists. This review describes the most pressing research questions in trauma, as well as new approaches to trauma research, with the aim to bring improved therapies to the bedside within the twenty-first century.

Systematic reviews and meta-analyses in neurosurgery Part II: a guide to designing the protocol.

Despite clearly established guidelines, recent audits have found the conduct and reporting of systematic reviews and meta-analyses (SRMAs) within neurosurgery to be relatively lackluster in methodological rigor and compliance. Protocols of SRMAs allow for planning and documentation of review methods, guard against arbitrary decision-making during the review process, and enable readers to assess for the presence of selective reporting. To aid transparency, authors should provide sufficient detail in their protocol so that the readers could reproduce the study themselves. Development of our guideline drew heavily from the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P) initiative. The objective of this article is not to enumerate every detail of this checklist, but to provide guidance to authors preparing their protocol, with examples, for a systematic review in neurosurgery. Particularly, we emphasize on the PICO framework - population (P), interventions (I), comparators (C), outcomes (O) - which is central to constructing a clinical question, defining the scope of the systematic review, defining and prioritizing the primary outcome, to specifying the eligibility criteria, designing the search strategy, and identifying potential sources of heterogeneity. We encourage our readers to make use of this guideline alongside the PRISMA-P 2015 statement, when drafting and appraising systematic review protocols.

Systematic reviews and meta-analyses in neurosurgery part I: interpreting and critically appraising as a guide for clinical practice.

Neurosurgeons are inundated with the Herculean task to keep abreast with the rapid pace at which clinical research is proliferating. Systematic reviews and meta-analyses (SRMAs) have consequently surged in popularity because when executed properly, they constitute the highest level of evidence, and may save busy neurosurgeons many hours of combing the literature. Well-executed SRMAs may prove instructive for clinical practice, but poorly conducted reviews sow confusion and may potentially cause harm. Unfortunately, many SRMAs within neurosurgery are relatively lackluster in methodological rigor. When neurosurgeons apply the results of an SRMA to patient care, they should start by evaluating the extent to which the employed methods have likely protected against misleading results. The present article aims to educate the reader about how to interpret an SRMA, to assess the potential relevance of its results in the special context of the neurosurgical patient population.

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.

Particularity, Engagement, Actionable Inferences, Reflexivity, and Legitimation tool for rigor in mixed methods implementation research.

BACKGROUND: Implementation science helps generate approaches to expedite the uptake of evidence in practice. Mixed methods are commonly used in implementation research because they allow researchers to integrate distinct qualitative and quantitative methods and data sets to unravel the implementation process and context and design contextual tools for optimizing the implementation. To date, there has been limited discussion on how to ensure rigor in mixed methods implementation research. PURPOSE: To present Particularity, Engagement, Actionable Inferences, Reflexivity, and Legitimation (PEARL) as a practical tool for understanding various components of rigor in mixed methods implementation research. DATA SOURCES: This methodological discussion is based on a nurse-led mixed methods implementation study. The PEARL tool was developed based on an interpretive, critical reflection, and purposive reading of selected literature sources drawn from the researchers' knowledge, experiences of designing and conducting mixed methods implementation research, and published methodological papers about mixed methods, implementation science, and research rigor. CONCLUSION: An exemplar exploratory sequential mixed methods study in nursing is provided to illustrate the application of the PEARL tool. The proposed tool can be a useful and innovative tool for researchers and students intending to use mixed methods in implementation research. The tool offers a straightforward approach to learning the key rigor components of mixed methods implementation research for application in designing and conducting implementation research using mixed methods. CLINICAL RELEVANCE: Rigorous implementation research is critical for effective uptake of innovations and evidence-based knowledge into practice and policymaking. The proposed tool can be used as the means to establish rigor in mixed methods implementation research in nursing and health sciences.

Building Family Interventions for Scalability and Impact.

Family nursing researchers are charged with addressing the conceptual and methodological underpinnings of family research when developing family-focused interventions. Step-by-step guidance is needed that integrates current science of intervention development with family science and helps researchers progress from foundational work to experimental work with policy integration. The purpose of this manuscript is to provide pragmatic, evidence-based guidance for advancing family intervention research from foundational work through efficacy testing. Guidance regarding the development of family interventions is presented using the first three of Sidani's five-stage method: (a) foundational work to understand the problem targeted for change; (b) intervention development and assessment of acceptability and feasibility; and (c) efficacy testing. Each stage of family intervention development is described in terms of process, design considerations, and policy and practice implications. Examples are included to emphasize the family lens. This manuscript provides guidance to family scientists for intervention development and implementation to advance family nursing science and inform policy.

Barriers and Facilitators to Youth Decision-Making Involvement in Families Referred for Stem Cell Transplant.

Youth prefer to be involved in treatment decisions, yet youth participation is minimally present in decisions like stem cell transplant (SCT) that require frequent medications and social isolation to be successful in curing cancer and chronic illness. The purpose of our study is to identify the barriers and facilitators to youth decision-making involvement in the youth-parent interaction when referred for treatment with SCT. We report qualitative findings from our theory-driven mixed-methods study. We thematically analyzed our field notes of youth and parent observations and audio-recordings during SCT consultations and semi-structured interviews. Data were collected from 10 youth, 8 to 16 (median 12) years of age, and their parents (n = 20). Three themes emerged: (a) Reluctant unless motivated, (b) Uncertain but capable, and (c) Limited unless supported. Our findings emphasize the critical role parents may take in facilitating youth involvement in decisions.

DENTAL PATIENT-REPORTED OUTCOMES UPDATE 2023.

The emergence and rapid development of disruptive innovations are quickly turning our profession into personalized dentistry, built upon evidence-based, data-oriented, and patient-centered research. In order to help improve the quality and quantity of patient-centered evidence in dentistry, further promote the wide and standard use of dental patient-reported outcomes (dPROs) and dental patient-reported outcome measures (dPROMs), the Journal of Evidence-Based Dental Practice has put together this special issue, the third of a series entitled Dental Patient-Reported Outcomes Update. A total of 7 solicited articles are collected in this issue. To put them into a broader perspective, this review provides a concise summary of key, selected PRO and dPRO articles published during 2023. A brief introduction to those articles included in this Special Issue follows. Four main domains are covered in this Special Issue: (1) dPROs and digital dentistry, (2) standardization of dPRO-related methodology, (3) current usage of dPROs and dPROMs in published research, and (iv) the significance and relevance of dPRO usage.

Improving the inclusion of transgender and nonbinary individuals in the planning, completion, and mobilization of cardiovascular research.

Cardiovascular disease is the leading cause of morbidity and mortality globally. Transgender and nonbinary (TNB) individuals face unclear but potentially significant cardiovascular health inequities, yet no TNB-specific evidence-based interventions for cardiovascular risk reduction currently exist. To address this gap, we propose a road map to improve the inclusion of TNB individuals in the planning, completion, and mobilization of cardiovascular research. In doing so, the adoption of inclusive practices would optimize cardiovascular health surveillance and care for TNB communities.

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

BACKGROUND: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed 'Studies Within A Trial' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment. METHODS: Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part. RESULTS: Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I2 = 0%). There was no effect on any other outcomes. CONCLUSIONS: Multimedia alongside written information did not improve trial recruitment rates. TRIAL REGISTRATION: ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

How do we build a comprehensive Vein-to-Vein (V2V) database for conduct of observational studies in transfusion medicine? Demonstrated with the Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric V2V database protocol.

BACKGROUND: The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is the fourth iteration of the National Heart, Lung, and Blood Institute's REDS program and includes a focus on pediatric populations. The REDS-IV-P Vein-to-Vein (V2V) database encompasses linked information from blood donors, blood components, and patients to facilitate studies in transfusion medicine. STUDY DESIGN AND METHODS: The V2V database is an Observational Medical Outcomes Partnership Common Data Model database. The study period is April 1, 2019 through December 31, 2023. Data from all donors and donations at participating blood centers, all blood components derived from the donations, and all inpatient visits and selected outpatient visits at participating hospitals are included. The database captures all information within patient data domains not restricting data to a preselected subset of medical records. RESULTS: The V2V database contains data from 7 blood centers and 22 hospitals. We project the database will have over 2 billion pieces of information from 1.3 million patients with 20.6 million healthcare encounters. The database will include data on approximately 1 million transfused units and 2.3 million donors with approximately 6.8 million donation visits. CONCLUSION: The REDS-IV-P V2V database is a comprehensive database with data from millions of blood donors, blood components, and patients. A diverse set of data from the encounters are included in the database such that emerging questions can likely be addressed. The Observational Medical Outcomes Partnership Common Data Model is an efficient, flexible, and increasingly used common data model. The final de-identified database will be publicly available.

Sickle cell disease and the need for blood: Barriers to donation for African, Caribbean, and Black young adults in Canada.

BACKGROUND: Many blood operators around the world face the challenge of increasing the number of donors of African ancestry to meet the transfusion needs of people living with sickle cell disease. This article reports results of the barriers to blood donation for young adults (aged 19-35) in Canada who identify as African, Caribbean, or Black. STUDY DESIGN AND METHODS: A community-based qualitative study was conducted by researchers from community organizations, blood operator, and universities. In-depth focus groups and interviews (n = 23) were conducted from Dec 2021 to Apr 2022 and thematic analysis was completed. RESULTS: Applying a socio-ecological model, multiple levels of interacting barriers to blood donation were identified. These included macro-level barriers (e.g., systemic racism, mistrust of the healthcare system, sociocultural beliefs and views about blood and sickle cell disease), mezzo-level barriers (e.g., deferral criteria, minimum hemoglobin levels, donor questionnaire, access, parental concerns), and microlevel barriers (e.g., limited knowledge of blood needs for people with sickle cell disease, lacking information about blood donation process, fear of needles, personal health concerns). DISCUSSION: This study is the first to focus on barriers to donation for African, Caribbean, and Black young adults across Canada. Parental concerns, informed by parents' experiences of inequitable healthcare and mistrust, emerged as a novel finding in our study population. Results suggest that higher order (macro-level) barriers influence and may reinforce lower order (mezzo- and microlevel) barriers. As such, interventions aimed at addressing barriers to donation should keep in view all levels with particular attention paid to higher order barriers.

Regular high-frequency whole blood donation and risk of cardiovascular disease in middle-aged and older blood donors in Australia.

BACKGROUND: Previous mixed findings on the associations between whole blood (WB) donation and risk of cardiovascular diseases (CVD) may in part reflect inadequate adjustment for the "healthy donor effect" (HDE). METHODS: We used the Sax Institute's 45 and Up Study linked with blood donation history and other health-related databases to examine the association between regular, high-frequency WB donation and the risk of CVD. To mitigate the impact of HDE, we used a "5-years qualification period," in which donors must donate at least 1 WB donation in the 1st and 5th year of "qualification period." We then compared the risk of CVD in the years following the "qualification period" between the regular high-frequency WB donors (≥2 WB donation in each qualification year) and others using Cox proportional-hazards models. Analyses were adjusted for potential confounders, such as sociodemographic, lifestyle, and health-related variables, and results are reported separately for male and female donors. RESULTS: A total of 2736 male and 2917 female donors were included in the analyses. The median years of follow-up per donor was 5.84 years (Q1-Q3, 5.47-6.23). The rate of CVD hospitalization was 11.20 and 4.50 per 1000 person-years for males and females, respectively. In fully adjusted models, the risk (hazard ratio) of CVD in regular high-frequency donors compared to other donors was 0.93 (95% Confidence Interval (CI), 0.68-1.29) for males and 0.79 (95% CI, 0.49-1.28) for females. CONCLUSIONS: We did not observe a statistically significant reduction of CVD risk in regular, high-frequency WB donors when adjusted for potential confounders.