Patient attitudes towards faecal sampling for gut microbiome studies and clinical care reveal positive engagement and room for improvement.

Faecal sample collection is crucial for gut microbiome research and its clinical applications. However, while patients and healthy volunteers are routinely asked to provide stool samples, their attitudes towards sampling remain largely unknown. Here, we investigate the attitudes of 780 Dutch patients, including participants in a large Inflammatory Bowel Disease (IBD) gut microbiome cohort and population controls, in order to identify barriers to sample collection and provide recommendations for gut microbiome researchers and clinicians. We sent questionnaires to 660 IBD patients and 112 patients with other disorders who had previously been approached to participate in gut microbiome studies. We also conducted 478 brief interviews with participants in our general population cohort who had collected stool samples. Statistical analysis of the data was performed using R. 97.4% of respondents reported that they had willingly participated in stool sample collection for gut microbiome research, and most respondents (82.9%) and interviewees (95.6%) indicated willingness to participate again, with their motivations for participating being mainly altruistic (57.0%). Responses indicated that storing stool samples in the home freezer for a prolonged time was the main barrier to participation (52.6%), but clear explanations of the sampling procedures and their purpose increased participant willingness to collect and freeze samples (P = 0.046, P = 0.003). To account for participant concerns, gut microbiome researchers establishing cohorts and clinicians trying new faecal tests should provide clear instructions, explain the rationale behind their protocol, consider providing a small freezer and inform patients about study outcomes. By assessing the attitudes, motives and barriers surrounding participation in faecal sample collection, we provide important information that will contribute to the success of gut microbiome research and its near-future clinical applications.

Assessing comfort level with pediatric skin specimens among dermatopathologists and pediatric pathologists: A national cross-sectional survey.

BACKGROUND: Cutaneous histopathologic diagnoses in children often differ from those in adults. Depending on practice setting, these specimens may be evaluated by dermatopathologists or pediatric pathologists. We sought to determine whether comfort level with pediatric dermatopathology is associated with prior training, pediatric dermatopathology exposure during fellowship, career duration, or specimen subtype. METHODS: We surveyed dermatopathologists and pediatric pathologists practicing in the United States. Training and practice variables were evaluated by multivariable regression for association with comfort level. RESULTS: Of the 156 respondents, 72% were dermatopathologists (response rate 11.6%) and 28% were pediatric pathologists (response rate 9.3%). Dermatopathologists reported higher comfort overall (P < .001); this was also true for inflammatory dermatoses and melanocytic neoplasms (P < .001). Thirty-four percent and 75% of dermatopathologists and pediatric pathologists, respectively, reported lower comfort with pediatric skin specimens than their usual cases. Pediatric pathologists were 28% more likely to refer these cases to colleagues. Among dermatopathologists, dermatology-trained were more comfortable than pathology-trained colleagues interpreting inflammatory dermatoses (P < .001). CONCLUSIONS: Pathologists' comfort with pediatric dermatopathology varied significantly based upon prior training, career duration, and specimen subtype. These results suggest opportunities for improving education in this domain.

Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection - a qualitative study.

BACKGROUND: Investigation of the microbiome during early life has stimulated an increasing number of cohort studies in pregnant and breastfeeding women that require non-invasive biospecimen collection. The objective of this study was to explore pregnant and breastfeeding women's perspectives on longitudinal clinical studies that require non-invasive biospecimen collection and how they relate to study logistics and research participation. METHODS: We completed in-depth semi-structured interviews with 40 women who were either pregnant (n = 20) or breastfeeding (n = 20) to identify their understanding of longitudinal clinical research, the motivations and barriers to their participation in such research, and their preferences for providing non-invasive biospecimen samples. RESULTS: Perspectives on research participation were focused on breastfeeding and perinatal education. Participants cited direct benefits of research participation that included flexible childcare, lactation support, and incentives and compensation. Healthcare providers, physician offices, and social media were cited as credible sources and channels for recruitment. Participants viewed lengthy study visits and child protection as the primary barriers to research participation. The barriers to biospecimen collection were centered on stool sampling, inadequate instructions, and drop-off convenience. CONCLUSION: Women in this study were interested in participating in clinical studies that require non-invasive biospecimen collection, and motivations to participate center on breastfeeding and the potential to make a scientific contribution that helps others. Effectively recruiting pregnant or breastfeeding participants for longitudinal microbiome studies requires protocols that account for participant interests and consideration for their time.

The psychological impact of COVID-19 on 'hidden' frontline healthcare workers.

BACKGROUND: The novel coronavirus disease (COVID-19) pandemic has led to rising death tolls and stressed healthcare systems, resulting in an unprecedented psychological stress on healthcare workers worldwide. However, the majority of studies only accounted for frontline healthcare workers with direct patient exposure. AIM: This study aims to look at the psychological impact of COVID-19 in a specific, vulnerable and yet hidden group of healthcare workers, namely laboratory healthcare workers who are at high risk exposure to SARS-CoV-2 virus from handling infected patients' blood samples, in addition to a marked increase in workload. METHOD: A multicentre study was conducted in Singapore via online questionnaire looking at psychological and physical impact of COVID-19 on laboratory healthcare workers. The Generalized Anxiety Disorder 7-item (GAD-7) scale, Zung Self-Rating Depression Scale (SDS) and Numeric rating scale on fear (NRS) were validated scores used in this study. Data analysis was performed using SPSS statistical software version 23 (IBM Corp). RESULTS: A total of 122 staffs participated and more than half of the cohort experienced mild to severe fear, anxiety and depression. Increase in depression score was also found to be associated with increased physical exhaustion (OR = 6.1, 95% CI 1.4-29.1, p = .02), loss of appetite (OR = 2.7, 95% CI 1.2-6.0, p = .02), poor sleep quality (OR = 7.5, 95% CI 2.9-19.4, p = .005), and the use of sedative (OR = 3.9, 95% CI 1.1-13.5, p = .03). CONCLUSIONS: Hence, it is imperative that prompt action needs to be taken to address the psychological needs of this vulnerable group of healthcare workers as the pandemic continues.

Perceptions on the collection of body fluids for research on persistence of Ebola virus: A qualitative study.

BACKGROUND: Against the background of the international public health emergency related to the Ebola outbreak in the Democratic Republic of Congo, in addition to other recent large Ebola epidemics, the issue of transmission due to viral persistence from survivors' body fluids is becoming increasingly urgent. Clinical research in which body fluids play a role is critical and semen testing programs are part of the suggested response to the outbreak. Broad acceptance and understanding of testing programs and research, often in resource poor settings, is essential for the success and sustainability of clinical studies and an accurate epidemic response. Study participants' perceptions on the collection of body fluids are therefore relevant for the programmatic planning and implementation of clinical studies. STUDY AIM AND METHODS: In this qualitative study we aimed to explore the perceptions on bio-sampling in the Sierra Leone Ebola Virus Persistence Study (SLEVP study). We were interested to understand how norms on gender and sexuality related to perceptions and experiences of study participants and staff, specifically, in what way perceptions of the body, on intimacy and on body fluids related to the study process. We purposively sampled former study participants for in-depth interviews and focus-group discussions. We conducted 56 in-depth interviews and eight focus group discussions with 93 participants. In a participatory approach we included study participants in the analysis of data. RESULTS: Overall the SLEVP study was well perceived by study participants and study staff. Study participants conceived the testing of their body fluids positively and saw it as a useful means to know their status. However, some study participants were ambivalent and sometimes reluctant towards sampling of certain body fluids (especially semen, blood and vaginal fluid) due to religious or cultural reasons. Self-sampling was described by study participants as a highly unusual phenomenon. Several narratives were related to the loss of body fluids (especially semen) that would make men weak and powerless, or women dizzy and sick (especially blood). Some rumors indicated mistrust related to study aims that may have been expressions of broader societal challenges and historical circumstances. These reservations could eventually be overcome by guaranteeing confidentiality and privacy and by comprehensive professional counseling. CONCLUSION: In the course of the sampling exercise, study participants were often obliged to transgress cultural and intimate boundaries. It is therefore important to understand the potential importance some of these perceptions have on the recruitment of study participants and the acceptability of studies, on a symbolic as well as a structural level. In order to capture any reservations it is necessary to provide plenty of possibilities of information sharing and follow-up of continuous consent.

Reasons for Not Attending Cervical Cancer Screening and Associated Factors in Rural Ethiopia.

Social, economic, and cultural factors have been associated with the level of participation in cervical cancer screening programs. This study identified factors associated with nonparticipation in cervical cancer screening, as well as reasons for not attending, in the context of a population-based, cluster-randomized trial in Ethiopia. A total of 2,356 women aged 30 to 49 years in 22 clusters were invited to receive one of two screening approaches, namely human papillomavirus (HPV) self-sampling or visual inspection with acetic acid (VIA). Participants and nonparticipants were analyzed according to their sociodemographic and economic characteristics. Reasons were determined for the refusal of women to participate in either screening method. More women in the VIA arm compared to the HPV arm declined participation in the screening [adjusted OR (AOR) 3.5; 95% confidence interval (CI), 2.6-4.8]. Women who declined attending screening were more often living in rural areas (AOR = 2.0; 95% CI, 1.1-3.5) and were engaged in informal occupations (AOR = 1.6; 95% CI, 1.1-2.4). The majority of nonattendants perceived themselves to be at no risk of cervical cancer (83.1%). The main reasons given for not attending screening for both screening approaches were lack of time to attend screening, self-assertion of being healthy, and fear of screening. We found that perceived time constraints and the perception of being at no risk of getting the disease were the most important barriers to screening. Living in rural settings and informal occupation were also associated with lower participation. Offering a swift and convenient screening service could increase the participation of women in cervical cancer screening at the community level.

Participant-Centered Strategies for Overcoming Barriers to Biospecimen Collection among Spanish-Speaking Latina Breast Cancer Survivors.

BACKGROUND: Latinos are underrepresented in biomedical research, particularly biomarker research, yet they constitute the nation's largest ethnic/racial minority. Optimal methods for obtaining biospecimens for biomarker research among Latinos need to be identified. To minimize barriers and enhance participation, this study developed and tested tailored strategies for collecting biomarkers of chronic stress and premature aging among Spanish-speaking Latina breast cancer survivors. METHODS: This study used a community-based participatory approach and selected hair and saliva as noninvasive biospecimens to assess telomere length, the cortisol awakening response (CAR), and hair cortisol concentration. We developed bilingual multimedia instructional materials, and community health workers assisted in collections. Telephone surveys assessed willingness to participate in future studies, barriers to sample collection, and recommendations for improving the strategies. RESULTS: A total of 103 participants were recruited over 18 months from two rural sites in California, and 88 were retained at 6-month follow-up. At baseline, rates of donating salivary DNA for telomere length measurement, saliva for CAR analysis, and hair for cortisol concentration were 98%, 89%, and 52%, respectively. At follow-up, rates were 83%, 76%, and 55%, respectively. The majority of participants reported being very willing to provide hair (72%) or saliva (74%) for future studies. CONCLUSIONS: Our results support the feasibility of including minorities in biomedical research. We report excellent rates of saliva collection when community partners are engaged in the process, and when patient-centered and culturally tailored recruitment methods are implemented. IMPACT: The development of methods to facilitate the inclusion of minorities in biomedical research is critical to eliminate racial/ethnic health disparities.

A Community-Based Approach to Biospecimen Collection Among Pacific Islanders.

This study tested the feasibility of collecting saliva samples from Pacific Islanders (PIs) via a community-based participatory research approach. Collection of saliva samples were conducted by trained and trusted PI community leaders at various partner sites. A total of 214 saliva samples were donated by PIs living in Southern California, more than half of whom were females between the ages of 18 and 35 years. Donors indicated that they donated because they wanted to help science and their community. A majority of donors reported a very positive experience with the donation process and were willing to donate saliva and hair samples in the future. The positive findings of this article highlight the importance of community input and participation.

Patient Perspectives About Decisions to Share Medical Data and Biospecimens for Research.

Importance: Patients increasingly demand transparency in and control of how their medical records and biospecimens are shared for research. How much they are willing to share and what factors influence their sharing preferences remain understudied in real settings. Objectives: To examine whether and how various presentations of consent forms are associated with differences in electronic health record and biospecimen sharing rates and whether these rates vary according to user interface design, data recipients, data and biospecimen items, and patient characteristics. Design, Setting, and Participants: For this survey study, a data and biospecimen sharing preference survey was conducted at 2 academic hospitals from May 1, 2017, to September 31, 2018, after simple randomization of patients to 1 of 4 options with different layout and formats of indicating sharing preferences: opt-in simple, opt-in detailed, opt-out simple, and opt-out detailed. Interventions: All participants were presented with a list of data and biospecimen items that could be shared for research within the same health care organization or with other nonprofit or for-profit institutions. Participating patients were randomly asked to select the items that they would share (opt-in) or were asked to select items they would not share (opt-out). Patients in these 2 groups were further randomized to select only among 18 categories vs 59 detailed items (simple vs detailed form layout). Main Outcomes and Measures: The primary end points were the percentages of patients willing to share data and biospecimen categories or items. Results: Among 1800 eligible participants, 1246 (69.2%) who completed their data sharing survey were included in the analysis, and 850 of these patients (mean [SD] age, 51.1 [16.7] years; 507 [59.6%] female; 677 [79.6%] white) responded to the satisfaction survey. A total of 46 participants (3.7%) declined sharing with the home institution, 352 (28.3%) with nonprofit institutions, and 590 (47.4%) with for-profit institutions. A total of 836 (67.1%) indicated that they would share all items with researchers from the home institution. When comparing opt-out with opt-in interfaces, all 59 sharing choice variables (100%) were associated with the sharing decision. When comparing simple with detailed forms, only 14 variables (23.7%) were associated with the sharing decision. Conclusions and Relevance: The findings suggest that most patients are willing to share their data and biospecimens for research. Allowing patients to decide with whom they want to share certain types of data may affect research that involves secondary use of electronic health records and/or biosamples for research.

Uptake of Cervical Cancer Screening in Ethiopia by Self-Sampling HPV DNA Compared to Visual Inspection with Acetic Acid: A Cluster Randomized Trial.

In Ethiopia, the standard method of cervical cancer screening is using Visual Inspection with Acetic Acid (VIA). Self-collection-based human papillomavirus (HPV) testing is assumed to improve the uptake of screening, especially for hard to reach populations. We investigated whether HPV DNA testing with the self-collection of cervical samples would be associated with increased uptake and adherence to procedures at the population level compared with VIA within defined rural population in Ethiopia. A total of 22 clusters (comprising 2,356 women ages 30-49 years) were randomized in two arms. Following the community mobilization, women of the clusters were invited to go either to the local health post for a self-collection-based HPV DNA testing (arm A) or Butajira Hospital for VIA screening (arm B). In the HPV arm, of the 1,213 sensitized women, 1,020 (84.1%) accessed the health post for self-sampling compared with the VIA arm, where 575 of 1,143 (50.5%) visited the hospital for VIA (P < 0.0001). Of those women who attended the VIA and HPV arms, 40% and 65.4% adhered to all procedures expected after screening, respectively. Out of women positive for high risk HPV, 122 (85%) attended VIA as a follow-up test. The trial demonstrated significantly higher levels of population-based uptake and adherence for self-collection HPV testing. Women were more receptive for VIA after their HPV testing result was positive. Self-collection HPV testing can be done at the local health facility and may significantly improve the uptake of cervical cancer screening in Ethiopia.

Evaluation of satisfaction with three different cervical cancer screening modalities: clinician-collected Pap test vs. HPV test by self-sampling vs. HPV test by urine sampling.

OBJECTIVE: Human papillomavirus testing by self-sampling and urine sampling might be alternatives to Papanicolaou test (Pap test) for cervical cancer screening (CCS), and may increase compliance and adherence thereto. The present study aimed to explore satisfaction and preferences for cervical screening modalities among Korean women. METHODS: In total, 732 women aged between 20 and 69 years responded to a questionnaire designed to survey the women's perceived satisfaction for the 3 CCS modalities: clinician-collected Pap test, self-collected vaginal sampling (self-sampling) and urine sampling. RESULTS: Overall satisfaction was significantly higher with both the self-sampling and urine sampling than the clinician-collected Pap test (odds ratio [OR]=2.01; 95% confidence interval [CI]=1.48-3.00 and OR=2.47; 95% CI=1.75-3.48, respectively). Psychological distress, including embarrassment, pain, anxiety, discomfort, and stress, with self-sampling and urine sampling were significantly lower than that with the Pap test. 52% of participants reported preferences for self-sampling in the next screening round. CONCLUSIONS: Korean women were more likely to report satisfaction with alternative modalities (self-sampling and urine sampling) for CCS in comparison to the Pap test. This suggests that self-collected modalities may help with improving CCS uptake rates by eliminating burden related with the Pap test. However, further studies for test accuracy and cost-effective analysis of the alternative modalities should be conducted in order to apply CCS.

Avaliação do serviço de coleta para exame colpocitológico pela escala SERVQUAL.

OBJECTIVE: To analyze women's perception of the quality of the service provided for colposcopy test in the city of Belém (PA), Brazil. METHOD: Quantitative-descriptive study on 400 women who underwent Pap test on the public healthcare network, using the Service Quality (SERVQUAL) model. We used the Cronbach's alpha index to measure the reliability of the scale, and data were analyzed by quartiles of the gaps of the dimensions: tangibility, responsiveness, reliability, assurance, and empathy. RESULTS: The assurance dimension, corresponding to the knowledge and courtesy of staff, featured the highest degree of importance to users; and empathy, which corresponds to the staff's concern with women's needs, featured the lower degree. The most expressive negative gaps concerned the structure of services and the attitude of healthcare professionals when collecting the material. CONCLUSION: All gaps featured negative relationship between what was expected and perceived, expressing dissatisfaction regarding the service.

Developing a culturally appropriate illustrated tool for the self-collection of anorectal specimens for the testing of sexually transmitted infections: lessons from Papua New Guinea.

BACKGROUND: Papua New Guinea (PNG) has a high prevalence of sexually transmitted infections (STIs). There is increasing evidence that anorectal STIs are important in terms of the dual epidemics of HIV and STIs in this setting. At the time of this study, anorectal STI testing was not possible, and there was no mechanism for self-collection of anorectal specimen among at risk 'key populations'. This paper documents the development of a culturally appropriate tool that has been used to facilitate self-collection of anorectal specimens with key populations in PNG. METHODS: This qualitative study involved four focus groups conducted with a purposive sample of 35 participants, including female sex workers, men who have sex with men and transgender women in Port Moresby and Goroka in 2015. During focus groups, participants reviewed and provided critical feedback for the adaption of a previously piloted and published pictorial anorectal specimen collection tool for use with key populations in PNG. RESULTS: The final instruction tools are presented in English language and Tok Pisin. To develop these, participants feedback resulted in six key areas of the existing instruction document being modified to ensure it was appropriate for use in PNG. These included translating complex words for sexual health issues (i.e. 'STIs', 'anorectal STIs', 'anus', 'anal sex'), biomedical instruments (i.e. 'specimen bottle', 'specimen packet' and 'swab'), and aspects of the clinical procedure (i.e. inserting the swab 3-4 cm into the anus to collect a specimen). The visual identity of the graphics was redesigned to localise the images for use in PNG. CONCLUSIONS: This paper describes the development of a culturally and linguistically appropriate tool for a biomedical and clinical intervention with key populations in PNG based around self-collection of anorectal specimens for molecular STI testing. The final tools have been used to facilitate the self-collection of anorectal specimens following a clear clinical protocol during a large bio-behavioural survey in PNG.

Avaliação do serviço de coleta para exame colpocitológico pela escala SERVQUAL / Evaluación del servicio de recolección para examen colpocitológico por la escala SERVQUAL / Avaliação do serviço de coleta para exame colpocitológico pela escala SERVQUAL

ABSTRACT Objective: To analyze women's perception of the quality of the service provided for colposcopy test in the city of Belém (PA), Brazil. Method: Quantitative-descriptive study on 400 women who underwent Pap test on the public healthcare network, using the Service Quality (SERVQUAL) model. We used the Cronbach's alpha index to measure the reliability of the scale, and data were analyzed by quartiles of the gaps of the dimensions: tangibility, responsiveness, reliability, assurance, and empathy. Results: The assurance dimension, corresponding to the knowledge and courtesy of staff, featured the highest degree of importance to users; and empathy, which corresponds to the staff's concern with women's needs, featured the lower degree. The most expressive negative gaps concerned the structure of services and the attitude of healthcare professionals when collecting the material. Conclusion: All gaps featured negative relationship between what was expected and perceived, expressing dissatisfaction regarding the service.

RESUMEN Objetivo: Analizar la percepción de mujeres acerca de la calidad del servicio de colpocitología oncótica en Belém (PA). Método: Estudio cuantitativo-descriptivo con 400 mujeres que realizaron el examen de colpocitología oncótica en la red pública de salud, utilizando el modelo Service Quality (SERVQUAL). Se utilizó el Alpha de Cronbach para medir la confiabilidad de la escala, y los datos fueron analizados por los cuartiles de los gaps de las dimensiones: tangibilidad, responsividad, confiabilidad, credibilidad y empatía. Resultados: La dimensión credibilidad, correspondiente al conocimiento y a la cortesía de los funcionarios, presentó mayor grado de importancia para las usuarias; y la empatía, que corresponde a la preocupación demostrada por los funcionarios con las necesidades de las mujeres, exhibió menor grado. Los gaps negativos más expresivos se refieren a la estructura de los servicios y a la actitud de los profesionales con ocasión de la recolección del material. Conclusión: Todos los gaps presentaron relación negativa entre lo esperado y lo percibido expresando la insatisfacción con relación al servicio.

RESUMO Objetivo: Analisar a percepção de mulheres acerca da qualidade do serviço de colpocitologia oncótica em Belém (PA). Método: Estudo quantitativo-descritivo com 400 mulheres que realizaram o exame de colpocitologia oncótica na rede pública de saúde, utilizando o modelo Service Quality (SERVQUAL). Utilizou-se o Alpha de Cronbach para medir a confiabilidade da escala, e os dados foram analisados pelos quartis dos gaps das dimensões: tangibilidade, responsividade, confiabilidade, credibilidade e empatia. Resultados: A dimensão credibilidade, correspondente ao conhecimento e cortesia dos funcionários, apresentou maior grau de importância para as usuárias, e a empatia, que corresponde à preocupação demonstrada pelos funcionários com as necessidades das mulheres, exibiu menor grau. Os gaps negativos mais expressivos dizem respeito à estrutura dos serviços e a atitude dos profissionais por ocasião da coleta de material. Conclusão: Todos os gaps apresentaram relação negativa entre o esperado e o percebido expressando a insatisfação em relação ao serviço.

A qualitative assessment of the acceptability of hepatitis C remote self-testing and self-sampling amongst people who use drugs in London, UK.

BACKGROUND: Hepatitis C (HCV) diagnosis and care is a major challenge for people who use illicit drugs, and is characterised by low rates of testing and treatment engagement globally. New approaches to fostering engagement are needed. We explored the acceptability of remote forms of HCV testing including self-testing and self-sampling among people who use drugs in London, UK. METHODS: A qualitative rapid assessment was undertaken with people who use drugs and stakeholders in London, UK. Focus groups were held with men who have sex with men engaged in drug use, people who currently inject drugs and people who formerly injected drugs (22 participants across the 3 focus groups). Stakeholders participated in semi-structured interviews (n = 5). We used a thematic analysis to report significant themes in participants' responses. RESULTS: We report an overarching theme of 'tension' in how participants responded to the acceptability of remote testing. This tension is evident across four separate sub-themes we explore. First, choice and control, with some valuing the autonomy and privacy remote testing could support. Second, the ease of use of self testing linked to its immediate result and saliva sample was preferred over the delayed result from a self administered blood sample tested in a laboratory. Third, many respondents described the need to embed remote testing within a supportive care pathway. Fourth, were concerns over managing a positive result, and its different meanings, in isolation. CONCLUSIONS: The concept of remote HCV testing is acceptable to some people who use drugs in London, although tensions with lived experience of drug use and health system access limit its relevance. Future development of remote testing must respond to concerns raised in order for acceptable implementation to take place.

A pilot study to understand feasibility and acceptability of stool and cord blood sample collection for a large-scale longitudinal birth cohort.

BACKGROUND: Few data are available to guide biological sample collection around the time of birth for large-scale birth cohorts. We are designing a large UK birth cohort to investigate the role of infection and the developing immune system in determining future health and disease. We undertook a pilot to develop methodology for the main study, gain practical experience of collecting samples, and understand the acceptability of sample collection to women in late pregnancy. METHODS: Between February-July 2014, we piloted the feasibility and acceptability of collecting maternal stool, baby stool and cord blood samples from participants recruited at prolonged pregnancy and planned pre-labour caesarean section clinics at University College London Hospital. Participating women were asked to complete acceptability questionnaires. RESULTS: Overall, 265 women were approached and 171 (65%) participated, with ≥1 sample collected from 113 women or their baby (66%). Women had a mean age of 34 years, were primarily of white ethnicity (130/166, 78%), and half were nulliparous (86/169, 51%). Women undergoing planned pre-labour caesarean section were more likely than those who delivered vaginally to provide ≥1 sample (98% vs 54%), but less likely to provide maternal stool (10% vs 43%). Pre-sample questionnaires were completed by 110/171 women (64%). Most women reported feeling comfortable with samples being collected from their baby (<10% uncomfortable), but were less comfortable about their own stool (19% uncomfortable) or a vaginal swab (24% uncomfortable). CONCLUSIONS: It is possible to collect a range of biological samples from women around the time of delivery, and this was acceptable for most women. These data inform study design and protocol development for large-scale birth cohorts.

Accuracy and Safety of the Cytosponge for Assessing Histologic Activity in Eosinophilic Esophagitis: A Two-Center Study.

OBJECTIVES: Management of eosinophilic esophagitis (EoE) requires repeated endoscopic mucosal sampling to assess disease activity. A less invasive and expensive means of monitoring of EoE is required. The objective of this study was to assess the accuracy, safety, and tolerability of the cytosponge compared to endoscopy and biopsy for histologic assessment of EoE. METHODS: In this prospective two-center cross-sectional study, patients with known EoE underwent cytosponge sampling followed by endoscopy and biopsy. Sample adequacy and eosinophil counts (eos/HPF) were determined for both cytosponge and endoscopic samples. The cytosponge was assessed for diagnostic accuracy, safety, and patient preference as compared to endoscopy. RESULTS: Six patients (7%) failed to swallow the sponge. One hundred and five procedures were successfully performed in 80 patients (66% male, 100% white, 19% stricture). The cytosponge sample was adequate in 102 and the biopsy in 104; 101 procedures had adequate samples by both techniques. Fifty-seven biopsies were graded as active EoE with ≥15 eos/HPF as the gold standard. Eosinophil counts highly correlated between the biopsy and cytosponge (r=0.78, P<0.0001). Using a cutoff of ≤15 eos/HPF for inactive disease, the sensitivity and specificity of the cytosponge was 75% and 86%, respectively. Six patients had active EoE on cytosponge not found on biopsy. For biopsies with inactive EoE, the cytosponge identified 38/44. No complications occurred, and cytosponge endoscopic abrasion scores were low (0.34/4). Patients preferred cytosponge to endoscopy with higher rating scores (7.27 vs. 6.11, P=0.002). CONCLUSIONS: Compared to endoscopy with biopsy, cytosponge provided a minimally invasive, safe, well tolerated, and accurate method to assess EoE histologic activity. (ClinicalTrial.gov number NCT01585103).

[Health agents' perspective on the incorporation of self-collected samples in HPV screening programs]. / La perspectiva de los agentes sanitarios sobre la incorporación programática de la autotoma del test de VPH.

The objective of this study was to analyze health agents' perception of self-collecting of samples for HPV testing among women and the degree of agreement by the agents to incorporate this approach into their daily tasks. A self-administered questionnaire was applied to 127/191 health agents that participated in the EMA Project (Proyecto Evaluación Modalidad Autotoma) in the province of Jujuy, Argentina, in 2012-2013. The health agents with and without the experience of offering self-collected sampling expressed a high degree of agreement towards adoption of the strategy (78.7%), given its potential to prevent cervical cancer and its contribution to health care for the women under their coverage. However, the health agents identified the extra work and problems linking to the formal health system as the main barriers to offering this modality in the future. The study found that self-collecting of samples is a practice that can be adopted by health agents in the province of Jujuy, but that it should be accompanied by support measures from the formal health system.

Enhancing Biospecimen Knowledge Among Health Care Providers and Representatives From Community Organizations.

In a personalized medicine environment, it is necessary to have access to a range of biospecimens to establish optimal plans for disease diagnosis and treatment for individual patients. Cancer research is especially dependent on biospecimens for determining ideal personalized treatment for patients. Unfortunately, the vast majority of biospecimens are collected from non-Hispanic White individuals; thus, minority representation is lacking. This has negative implications for comprehensive cancer treatment. The Geographic Management of Cancer Health Disparities Program (GMaP) Region 6 implemented a series of biospecimen education seminars adapted from the Biospecimen and Biobanking module of an existing Cancer Education and Training Program. Regional GMaP partners participated in a train-the-trainer webinar to familiarize themselves with the training materials. Participants trained by the trainers completed pre- and posttests to document changes in awareness, knowledge, and intention. Nine biospecimen education seminars were offered in 2013; 255 health care professionals and representatives from community organizations attended. Participants demonstrated a significant increase in knowledge, intention to donate samples, and intention to talk to patients about biospecimen sample donation. Representatives from community organizations had more improvement on knowledge scores than health care providers. Participation in a well-designed biospecimen education program may ameliorate some of the distrust of biomedical research experienced by racial/ethnic minorities and, in turn, increase needed minority representation in biospecimen collection.