Recruitment Of Study Participants Research Articles

Evaluation of Technology-Based Peer Support Intervention Program for Preventing Postnatal Depression: Protocol for a Randomized Controlled Trial.

BackgroundMultiple international agencies, including the World Health Organization and the International Monetary Fund, have emphasized the importance of maternal mental health for optimal child health and development. Adequate social support is vital for the most vulnerable to postpartum mood disorders. Hence, an urgent need for sustainable social support programs to aid mothers ease into their new parenting role exists.ObjectiveThis study protocol aims to examine the effectiveness of a technology-based peer support intervention program among mothers at risk for postnatal depression in the early postpartum period.MethodsA randomized controlled 2-group pretest and repeated posttest experimental design will be used. The study will recruit 118 mothers from the postnatal wards of a tertiary public hospital in Singapore. Eligible mothers will be randomly allocated to receive either the peer support intervention program or routine perinatal care from the hospital. Peer volunteers will be mothers who have experienced self-reported depression and will be receiving face-to-face training to support new mothers at risk of depression. Outcome measures include postnatal depression, anxiety, loneliness, and social support. Data will be collected at immediate postnatal period (day of discharge from the hospital), at fourth week and twelfth week post childbirth.ResultsThe recruitment and training of peer support volunteers (N=20) ended in June 2017, whereas recruitment of study participants commenced in July 2017 and is still ongoing. The current recruitment for new mothers stands at 73, with 36 in the control group and 37 in the intervention group. Data collection is projected to be completed by May 2018.ConclusionsThis study will identify a potentially effective and clinically useful method to prevent postnatal depression in new mothers, which is the top cause of maternal morbidity. Receiving social support from others who share similar experiences may enhance the positive parenting experiences of mothers, which in turn can improve the psychosocial well-being of the mothers, tighten mother-child bond, and enhance overall family dynamics for mothers and infants.Trial RegistrationInternational Standard Randomized Controlled Trial Number ISRCTN14864807; http://www.isrctn.com/ISRCTN14864807 (Archived by WebCite at http://www.webcitation.org/6xtBNvBTX)

Detecting Anatomical Variations of Coeliac Trunk Branching Pattern in the Population of Karachi Using 3D Multidetector Computed Tomographic Angiography (MDCTA)

Objective: To find out the frequency of variations in coeliac trunk branching pattern by Using 3D Multidetector Computer Tomographic Angiography (MDCTA),in patients referred to Radiology Department of Ziauddin University Hospital with abdominal pain, altered bowel habits, kidney or adrenal pathologies
 Method: For this study, 160 individuals aged 20-60 years, without any abdominal vascular or upper ab- dominal visceral disease who presented to Radiology Department, Ziauddin University Hospital, Clifton Karachi, for abdominal 3D-MDCTA (3-dimensional multidetector computed tomographic angiography) from March 2017 to August 2017 were recruited in this study. It was a cross-sectional study and samples were collected through non-probability convenience sampling technique. Recruitment of study participants was done from patients who were referred to radiology department of Ziauddin University Hospital for abdominal contrast MDCTA examination due to various indications such as abdominal pain, altered bowel habits, kidney and adrenal pathologies. Persons having serum creatinine levels <1.4 mg/dl with no hepatobiliary pathologies, pancreatic or abdominal vascular lesions were included while patient having, abdominal malignancy distorting vascular anatomy, vasculitis and atherosclerosis were ex- cluded from the study. Patients having history of liver transplant or upper abdominal surgeries or those having history of allergic reaction to contrast agents and pregnant ladies were also excluded from the study. Coeliac trunk variations were categorised according to Uflacker's classification into 8 types. Statis- tical analysis was done on SPSS version 20. Data is presented in percentages and frequencies.
 Results: Classical coeliac trunk (type I) was present in 134 out of 160 (83.9%) individuals while 26 (16.1%) individuals showed coeliac trunk variations. Type II and type V variations were second most fre- quent variations i.e. in 9 (5.6%) individuals each, followed by type VII in 5 (3.6%) individuals. Type III, IV and VI showed variations in 1 (0.6%) individual each. Type VIII was not found in our sample.
 Conclusion: The present study reports normal configuration of coeliac trunk i.e, classic or type I coeliac trunk in 83.9% individuals and coeliac trunk variations in 16.1% individuals.

Role of pharmacokinetic modeling and simulation in precision dosing of anticancer drugs

: The prospect of precision dosing in oncology is attractive for several reasons. Many anticancer drugs display narrow therapeutic indices, where suboptimal therapy may lead to severe patient outcomes. Clinical study participant recruitment is seldom extended beyond the intended patient population, leading to difficulties in patient recruitment in dedicated clinical trials. The high rate of non-responders and high cost of cancer therapy warrant novel solutions to increase clinical effectiveness and cost-benefit, pharmacokinetic (PK) modeling and model-informed precision dosing (MIPD) can help to maximize these. PK modeling provides a quantitative framework to account for inter-individual variability in drug exposure, the influence of covariates and extrapolation to special populations or drug-drug interactions, using physiologically-based PK (PBPK) modeling. Here we present the current state of PK modeling in precision dosing of anticancer drugs and illustrate its utility, based on an extensive literature review and numerous case examples from both pharmaceutical industry and healthcare focused research. While some great progress has been made in implementing model-informed dosage guidance in the drug label and much research has been carried out to address clinically relevant dosing questions, the uptake of MIPD has been modest in healthcare. The success of PK modeling in industry has been made possible through collaborative efforts between regulators, industry and academia. Collaboration between academia, healthcare and industry, and financial support for research into patient benefit, cost-benefit and clinical effectiveness of these approaches is imperative for wider adaption of PK modeling in precision dosing of anticancer drugs.

Anal sexual experience and HIV risk awareness among female sex workers in Dire Dawa, eastern Ethiopia

BackgroundFemale sex workers have been disproportionately affected with HIV and anal sexual experience elevate their vulnerability. Anal intercourse has more risk of HIV transmission than vaginal intercourse for receptors that coupled with low condom and proper lubricant use behavior during anal sex. Besides majority of them did not understand HIV transmission risk of anal intercourse. In Ethiopia, studies on anal sexual experience is almost none existent, so the purpose of this study is to explored anal sexual experience and HIV transmission risk awareness among female sex worker in Dire Dawa, Eastern Ethiopia.MethodQualitative study with thematic analysis approach was conducted among 18 female sex workers and recruitment of study participants performed until saturation of information. The principal investigator conducted in-depth interviews using local language (Amharic) and it was recorded on audio recorder. Tape recorded data was transcribed and translated to English and entered into open code version 3.4 for coding and theme identification. Data collection conducted simultaneously with data analysis.ResultFemale sex workers practiced anal sex for different themes like financial influence, coercion, intentionally, peer pressure and as a sign of intimacy and love. Coercion, negative attitudes, poor awareness about HIV transmission risks of anal sex and protection capacity of condom and proper lubricants are the identified themes for not using condom and proper lubricants during anal sex by female sex workers. Inaccessibility and unavailability of health services for issues related to anal sex was the core reason for female sex workers’ misperception and risk anal sexual experience.ConclusionFemale sex workers practiced anal sex without risk reduction approaches and they did not understand exacerbated risk of anal sex to HIV transmission. Stakeholders including ministry of health need to incorporate potential awareness raising tasks and programs about risk of anal sex and methods of risk reduction for female sex workers.

Prevalence and pattern of helmet-induced headache among Danish military personnel

Abstract Aims Headache is a leading reason to seek medical care. Several subtypes of headaches have been defined, one of which is external compression headache. This headache is due to an external physical compression applied on the head. It affects approximately 4% of the general population; however, certain populations for example construction workers and military personnel with particular needs of headwear or helmet are at higher risk for development of this type of headache. Generally, external compression headache is poorly studied and there is no report on helmet-induced headache among Danish military personnel. This survey-based study was designed to investigate prevalence and pattern of helmet-induced external compression headache among these personnel. Methods Questionnaires were carefully developed and delivered to a total of 279 participants who use helmets in the Danish military service. The military of the Northern Jutland region of Denmark facilitated recruitment of study participants. Questionnaires were delivered on paper and anonymous answers were collected and used for further analysis. Data were handled using descriptive statistics. Results Up to 30% of the participants reported headache in relation to wearing the military helmet. Headache was defined as moderate intensity with pressing pain quality mostly located in front of the head. Two types of helmets in this study were different in the weight and padding of the inner part and delivered different pattern of pressure; while one evenly delivered pressure on multiple head regions, the other delivered pressure mostly on the sides and top of the head. This suggests that helmet pressure and headache location might be associated. Conclusions This study was first to demonstrate prevalence and pattern of helmet-induced headache among military personnel in North Jutland, Denmark. Findings of this study call for further attention to helmet-induced headache and strategies to minimize the burden, for example by design of appropriate helmets.

Does the use of the Informed Healthcare Choices (IHC) primary school resources improve the ability of grade-5 children in Uganda to assess the trustworthiness of claims about the effects of treatments: protocol for a cluster-randomised trial

BackgroundThe ability to appraise claims about the benefits and harms of treatments is crucial for informed health care decision-making. This research aims to enable children in East African primary schools (the clusters) to acquire and retain skills that can help them make informed health care choices by improving their ability to obtain, process and understand health information. The trial will evaluate (at the individual participant level) whether specially designed learning resources can teach children some of the key concepts relevant to appraising claims about the benefits and harms of health care interventions (treatments).MethodsThis is a two-arm, cluster-randomised trial with stratified random allocation. We will recruit 120 primary schools (the clusters) between April and May 2016 in the central region of Uganda. We will stratify participating schools by geographical setting (rural, semi-urban, or urban) and ownership (public or private).The Informed Healthcare Choices (IHC) primary school resources consist of a textbook and a teachers’ guide. Each of the students in the intervention arm will receive a textbook and attend nine lessons delivered by their teachers during a school term, with each lesson lasting 80 min. The lessons cover 12 key concepts that are relevant to assessing claims about treatments and making informed health care choices. The second arm will carry on with the current primary school curriculum.We have designed the Claim Evaluation Tools to measure people’s ability to apply key concepts related to assessing claims about the effects of treatments and making informed health care choices. The Claim Evaluation Tools use multiple choice questions addressing each of the 12 concepts covered by the IHC school resources. Using the Claim Evaluation Tools we will measure two primary outcomes: (1) the proportion of children who ‘pass’, based on an absolute standard and (2) their average scores.DiscussionAs far as we are aware this is the first randomised trial to assess whether key concepts needed to judge claims about the effects of treatment can be taught to primary school children. Whatever the results, they will be relevant to learning how to promote critical thinking about treatment claims.Trial status: the recruitment of study participants was ongoing at the time of manuscript submission.Trial registrationPan African Clinical Trial Registry, trial identifier: PACTR201606001679337. Registered on 13 June 2016.

Sequential recruitment of study participants may inflate genetic heritability estimates.

After the success of genome-wide association studies to uncover complex trait loci, attempts to explain the remaining genetic heritability (h 2) are mainly focused on unraveling rare variant associations and gene-gene or gene-environment interactions. Little attention is paid to the possibility that h 2 estimates are inflated as a consequence of the epidemiological study design. We studied the time series of 54 biochemical traits in 4373 individuals from the Cooperative Health Research In South Tyrol (CHRIS) study, a pedigree-based study enrolling ten participants/day over several years, with close relatives preferentially invited within the same day. We observed distributional changes of measured traits over time. We hypothesized that the combination of such changes with the pedigree structure might generate a shared-environment component with consequent h 2 inflation. We performed variance components (VC) h 2 estimation for all traits after accounting for the enrollment period in a linear mixed model (two-stage approach). Accounting for the enrollment period caused a median h 2 reduction of 4%. For 9 traits, the reduction was of >20%. Results were confirmed by a Bayesian Markov chain Monte Carlo analysis with all VCs included at the same time (one-stage approach). The electrolytes were the traits most affected by the enrollment period. The h 2 inflation was independent of the h 2 magnitude, laboratory protocol changes, and length of the enrollment period. The enrollment process may induce shared-environment effects even under very stringent and standardized operating procedures, causing h 2 inflation. Including the day of participation as a random effect is a sensitive way to avoid overestimation.

Motivations of participants in the citizen science of microbiomics: data from the British Gut Project.

The establishment of databases for research in human microbiomics is dependent on the recruitment of sufficient numbers and diversity of participants. Factors that support or impede participant recruitment in studies of this type have not yet been studied. We report the results of a survey aimed at establishing the motivations of participants in the British Gut Project, a research project that relies on volunteers to provide samples and to help fund the project. The two most frequently reported motivations for participation were altruism and solidarity. Low education levels appeared to be a recruitment obstacle. More than half of our 151 respondents said they would participate in further citizen-science projects; 38% said they would not participate in a similar project if it was for-profit or in a project that did not release data sets in repositories accessible to scientists (30%). The desire to take part in research was reported as a key motivation for participation in the British Gut Project (BGP). Such prosocial motivations can be mobilized for the establishment of large data sets for research.Genet Med advance online publication 26 January 2017.

Factors Affecting Recruitment of Participants for Studies of Diabetes Technology in Newly Diagnosed Youth with Type 1 Diabetes: A Qualitative Focus Group Study with Parents and Children.

Background: Relatively little is known about parents' or children's attitudes toward recruitment for, and participation in, studies of new diabetes technologies immediately after diagnosis. This study investigated factors affecting recruitment of participants for studies in newly diagnosed youth with type 1 diabetes.Methods: Qualitative focus group study incorporating four recorded focus groups, conducted in four outpatient pediatric diabetes clinics in large regional hospitals in England. Participants comprised four groups of parents (n = 22) and youth (n = 17) with type 1 diabetes, purposively sampled on the basis of past involvement (either participation or nonparticipation) in an ongoing two-arm randomized trial comparing multiple daily injection with conventional continuous subcutaneous insulin infusion regimens from the onset of type 1 diabetes.Results: Stress associated with diagnosis presents significant challenges in terms of study recruitment, with parents demonstrating varied levels of willingness to be approached soon after diagnosis. Additional challenges arise regarding the following: randomization when study arms are perceived as sharply differentiated in terms of therapy effectiveness; burdens arising from study participation; and the need to surrender new technologies following the end of the study. However, these challenges were mostly insufficient to rule out study participation. Participants emphasized the benefits and reassurance arising from support provided by staff and fellow study participants.Conclusions: Recruitment to studies of new diabetes technologies immediately after diagnosis in youth presents significant challenges, but these are not insurmountable. The stress and uncertainty arising from potential participation may be alleviated by personalized discussion with staff and peer support from fellow study participants.

Rare neurological channelopathies--networks to study patients, pathogenesis and treatment.

Each of the thousands of rare neurological diseases requires a widely distributed network of centres, investigators and patients, so as to foster multidisciplinary investigations and involve sufficient numbers of patients in the discovery of disease pathogenesis and novel treatment. In this Review, we highlight the value of this collaborative approach in patient-oriented research into rare neurological channelopathies. Two networks, the Consortium for Clinical Investigations of Neurological Channelopathies (CINCH) and the Clinical Research Consortium for Studies of Cerebellar Ataxias (CRC-SCA), provide a link between patients with rare channelopathies and investigators who are studying disease pathogenesis and developing novel treatments. Interactions between patients, researchers and advocacy groups promote shared agendas that benefit patient education and recruitment, research collaboration and funding, and training and mentoring of junior investigators who are attracted to the study of the diseases that provide the focus for the two networks. Here, we discuss how linkage of national and international centres has enabled recruitment of study participants, provided opportunities for novel studies of pathogenesis, and facilitated successful clinical trials.

A Systematic Review of Experimental Strategies Aimed at Improving Motor Function after Acute and Chronic Spinal Cord Injury.

While various approaches have been proposed in clinical trials aimed at improving motor function after spinal cord injury in humans, there is still limited information regarding the scope, methodological quality, and evidence associated with single-intervention and multi-intervention approaches. A systematic review performed using the PubMed search engine and the key words "spinal cord injury motor recovery" identified 1973 records, of which 39 were selected (18 from the search records and 21 from reference list inspection). Study phase ( clinicaltrials.org criteria) and methodological quality (Cochrane criteria) were assessed. Studies included proposed a broad range of single-intervention (encompassing cell therapies, pharmacology, electrical stimulation, rehabilitation) (encompassing cell therapies, pharmacology, electrical stimulation, rehabilitation) and multi-intervention approaches (that combined more than one strategy). The highest evidence level was for Phase III studies supporting the role of multi-intervention approaches that contained a rehabilitation component. Quality appraisal revealed that the percentage of selected studies classified with high risk of bias by Cochrane criteria was as follows: random sequence generation = 64%; allocation concealment = 77%; blinding of participants and personnel = 69%; blinding of outcome assessment = 64%; attrition = 44%; selective reporting = 44%. The current literature contains a high proportion of studies with a limited ability to measure efficacy in a valid manner because of low methodological strength in all items of the Cochrane risk of bias assessment. Recommendations to decrease bias are discussed and include increased methodological rigor in the study design and recruitment of study participants, and the use of electrophysiological and imaging measures that can assess functional integrity of the spinal cord (and may be sufficiently sensitive to detect changes that occur in response to therapeutic interventions).

Integrating Social Media into Urologic Health care: What Can We Learn from Other Disciplines?

Social media (SoMe) have become an integral part in many aspects of personal and professional life. With current uptake rates of 50-70% among urologists, SoMe platforms merit huge potential for dissemination of information and professional exchange among stakeholders in urology. Application of SoMe includes conference conversations via tweet chats, health education via YouTube videos, and Twitter online journal clubs. In addition, a number of urology journals have embraced SoMe to allow rapid dissemination of their content and engagement with their readers. Guidance for the appropriate use of SoMe is provided to urologists by several organizations. Besides urology, other disciplines have adopted SoMe for a variety of areas: continuing professional development, awareness of rare diseases, recruitment of study participants, patient education and support, and publicizing research. Openness to new approaches is the basic prerequisite for a transfer of successful concepts embraced by other specialties, to the field of urology.

Feasibility and acceptability of TRANSFoRm to improve clinical trial recruitment in primary care.

Recruitment of study participants is a challenging process for health professionals and patients. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) clinical trial tools enable automated identification, recruitment and follow-up in clinical trials, potentially saving time, effort and costs for all parties involved. This study evaluates the acceptability and feasibility of TRANSFoRm to improve clinical trial recruitment in primary care. A feasibility study was conducted in three general practices in Poland. Participants were physicians and patients with gastro-oesophageal reflux disease. Semi-structured interviews were held to obtain feedback about the usefulness, ease of use and overall experience with the TRANSFoRm tools and to identify potential usability issues. Data were analysed thematically. A total of 5 physicians and 10 patients participated in the study. Physicians were satisfied with the usefulness of the system, as it enabled easier and faster identification, recruitment and follow-up of patients compared with existing methods. Patients found the TRANSFoRm apps easy to use to report patient outcomes. However, they also felt that the apps may not be useful for patients with limited exposure to smartphone and web technologies. Two main usability issues were identified: physicians could not access the result of the randomization at the end of each visit, and participants could not locate the follow-up reminder email. This study provides new evidence on the acceptability and feasibility of TRANSFoRm to enable automated identification, recruitment and follow-up of study participants in primary care trials. It also helps to better understand and address users' requirements in eHealth-supported clinical research.

Validation and application of a core set of patient-relevant outcome domains to assess the effectiveness of multimodal pain therapy (VAPAIN): a study protocol

IntroductionMultimodal pain therapy (MPT) has been established accounting for biopsychosocial consideration in diagnostic and therapy. MPT seems to be effective, but comparability of studies is limited due to diversity of...

A Novel Health Information Technology Communication System to Increase Caregiver Activation in the Context of Hospital-Based Pediatric Hematopoietic Cell Transplantation: A Pilot Study.

BackgroundPediatric hematopoietic cell transplantation (HCT), commonly referred to as blood and marrow transplantation (BMT), is an intense treatment modality that requires the involvement of engaged caregivers during the patient’s (child’s) prolonged hospitalization. The ubiquity of electronic health records (EHRs) and a trend toward patient-centered care could allow a novel health information technology (IT) system to increase parental engagement. The paucity of research on acute care, hospital-based (inpatient) health IT applications for patients or caregivers provides an opportunity for testing the feasibility of such applications. The pediatric BMT population represents an ideal patient group to conduct an evaluation due to the lengthy inpatient stays and a heightened need for patient activation.ObjectiveThe primary objective of this study is to assess the feasibility of implementing the BMT Roadmap in caregivers as an intervention during their child’s inpatient hospitalization. The BMT Roadmap is an inpatient portal prototype optimized for tablet with a user-centered design. It integrates patient-specific laboratory and medication data from the EHR in real-time and provides support in terms of discharge goals, home care education, and other components. Feasibility will be proven if (1) the BMT Roadmap functions and can be managed by the study team without unexpected effort, (2) the system is accessed by users at a defined minimum threshold, and (3) the qualitative and quantitative research conducted provides quality data that address the perceived usefulness of the BMT Roadmap and could inform a study in a larger sample size.MethodsThis will be a single-arm, nonrandomized feasibility study. We aim to enroll 10 adult caregivers (age ≥ 18 years) of pediatric patients (aged 0-25 years) undergoing autologous (self-donor) or allogeneic (alternative donor) BMT. Assenting minors (aged 10-18) will also be invited to participate. Recruitment of study participants will take place in the outpatient pediatric BMT clinic. After signing an informed consent, the research study team will provide participants with the BMT Roadmap, available on an Apple iPad, which will used throughout the inpatient hospitalization. To measure the study outcomes, approximately 6-8 semistructured qualitative interviews will be conducted periodically from pre-BMT to 100 days post-BMT and an additional 15-20 semistructured interviews will be conducted among BMT health care providers to assess perceived usefulness and usability of the system, as well as any associated workflow impacts. Quantitative survey instruments will only be administered to adult participants (age ≥ 18 years).ResultsRecruitment will begin in September 2015, and preliminary findings are expected in 2016.ConclusionsThis protocol offers a framework for the design and analysis of a personalized health IT system that has the potential to increase patient and caregiver engagement in acute care, hospital-based contexts.

Participant Recruitment for Studies on Disability and Work: Challenges and Solutions.

Purpose A number of key issues related to employment of persons with disabilities demand ongoing and effective lines of inquiry. There is evidence, however, that work researchers struggle with recruitment of participants, and that this may limit the types and appropriateness of methods selected. This two phase study sought to identify the nature of recruitment challenges in workplace-based disability research, and to identify strategies for addressing identified barriers. Methods The first phase of this study was a scoping review of the literature to identify the study designs and approaches frequently used in this field of inquiry, and the success of the various recruitment methods in use. In the second phase, we used qualitative methods to explore with employers and other stakeholders in the field their perceived challenges related to participating in disability-related research, and approaches that might address these. Results The most frequently used recruitment methods identified in the literature were non-probability approaches for qualitative studies, and sampling from existing worker databases for survey research. Struggles in participant recruitment were evidenced by the use of multiple recruitment strategies, and heavy reliance on convenience sampling. Employers cited a number of barriers to participation, including time pressures, fear of legal reprisal, and perceived lack of relevance to the organization. Conclusions Participant recruitment in disability-related research is a concern, particularly in studies that require collection of new data from organizations and individuals, and where large probability samples and/or stratified or purposeful samples are desirable. A number of strategies may contribute to improved success, including development of participatory research models that will enhance benefits and perceived benefits of workplace involvement.

Are patient and relationship variables associated with participation of intimate partners in couples research?

Recruitment of participants for studies focusing on couples facing illness is a challenging task and participation decline may be associated with nonrandom factors creating bias. This study examines whether patient and relationship characteristics are associated with partner participation in research. Patients invited to participate in a cross-sectional study on adaptation and quality of life after renal transplantation were asked to forward information about an add-on study to their partners. A total of 456 participating patients had a partner; 293 of the partners showed interest in the study and 206 actually completed the questionnaire. Backward logistic regression analyses revealed that demographic, illness, and personal characteristics of the patient were not associated with partner interest in the study nor actual partner participation. However, partners who indicated interest in the study showed more active engagement toward the patients (as reported by the patients). Furthermore, patients of partners who actually completed the questionnaire reported less negative affect and higher relationship satisfaction than patients whose partner did not participate in the study. It is encouraging that of the large number of variables tested, only 2 were associated with the participation of partners. Nevertheless, well-functioning couples appear to be overrepresented in our study, calling for specific effort to include marital distressed couples in research focusing on dyadic adaptation to illness.

Abstract A35: Barriers faced and enablers used by community health workers in 3 underserved communities on cervical cancer screening among Haitian, Hispanic, and African American women

Abstract As trusted members of their communities, community health workers (CHWs) have the potential to link hard-to-reach underserved populations with appropriate health care. As part of a National Cancer Institute (NCI)-funded initiative, we are examining the effectiveness of CHWs at increasing cervical cancer screening among minority women. CHWs are placed at one of three federally qualified health centers (FQHCs)/FHQC-look alike and obtain additional input from project specific Community Advisory Boards (CABs) in each community. Using a mixed methods approach consisting of quantitative recruitment data as well as key informant interviews we have identified several barriers and enablers for outreach, recruitment and retention of participants in our project. CHW characteristics facilitating study participant recruitment and retention include: personality, prior field experience, language, cultural congruence, degree of familiarity with community, ability to connect with their CAB members and degree of interaction with existing resources at their respective FQHCs (programmatic, structural, environmental and personnel). Ongoing CWH training and quality control were also important enablers of achieving our recruitment targets. Study participant characteristics such as cultural norms/beliefs, immigration status, health insurance, and economic factors (ability to meet clinic co-payments) were frequently cited as barriers. Structural/organizational characteristics of each FQHCs such as how health services are delivered, paperwork requirements, accessibility of location and tight linkages with local health departments also served as enablers and/or barriers. Lessons learned from our CHW led cervical cancer screening study can be applied to many distinct community based programs aimed at improving health care in underserved communities. Note: This abstract was withdrawn after the Proceedings was printed and was not presented at the conference. Citation Format: Brendaly Rodriguez, Shelia McCann, Olveen Carrasquillo, Erin Kobetz, Anthony Amofah, Tulay Koru-Sengul. Barriers faced and enablers used by community health workers in 3 underserved communities on cervical cancer screening among Haitian, Hispanic, and African American women. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A35. doi:10.1158/1538-7755.DISP13-A35

Feasibility and quality development of biomaterials in the pretest studies of the German National Cohort

The German National Cohort (GNC) is designed to address research questions concerning a wide range of possible causes of major chronic diseases (e.g. cancer, diabetes, infectious, allergic, neurologic and cardiovascular diseases) as well as to identify risk factors and prognostic biomarkers for early diagnosis and prevention of these diseases. The collection of biomaterials in combination with extensive information from questionnaires and medical examinations represents one of the central study components. In two pretest studies of the German National Cohort conducted between 2011 and 2013, a range of biomaterials from a defined number of participants was collected. Ten study centres were involved in pretest1 and 18study centres were involved in pretest2. Standard operation procedures (SOP) were developed and evaluated to minimize pre-analytical artefacts during biosample collection. Within the pretest studies different aspects concerning feasibility of sample collection/preparation [pretest1 (a)] and quality control of biomarkers and proteome analyses were investigated [pretest 1 (b), (c)]. Additionally, recruitment of study participants for specific projects and examination procedures of all study centres in a defined time period according to common standards as well as transportation and decentralized storage of biological samples were tested (pretest2). These analyses will serve as the basis for the biomaterial collection in the main study of the GNC starting in 2014. Participants, randomly chosen from the population (n = 1000 subjects recruited at ten study sites in pretest1) were asked to donate blood, urine, saliva and stool samples. Additionally, nasal and oropharyngeal swabs were collected at the study sites and nasal swabs were collected by the participants at home. SOPs for sample collection, preparation, storage and transportation were developed and adopted for pretest2. In pretest2, 18study sites (n = 599subjects) collected biomaterials mostly identical to pretest 1. Biomarker analyses to test the quality of the biomaterials were performed. In pretest1 and 2, it was feasible to collect all biomaterials from nearly all invited participants without major problems. The mean response rate of the subjects was 95 %. As one important result we found for example that after blood draw the cellular fraction should be separated from the plasma and serum fractions during the first hour with no significant variation for up to 6h at 4 ℃ for all analysed biomarkers. Moreover, quality control of samples using a proteomics approach showed no significant clustering of proteins according to different storage conditions. All developed SOPs were validated for use in the main study after some adaptation and modification. Additionally, electronic and paper documentation sheets were developed and tested to record time stamps, volumes, freezing times, and aliquot numbers of the collected biomaterials. The collection of the biomaterials was feasible without major problems at all participating study sites. However, the processing times were in some cases too long. To avoid pre-analytical artefacts in sample collection, appropriate standardisation among the study sites is necessary. To achieve this, blood and urine collection will have to be adapted to specific conditions of usage of liquid handling robots, which will be available at all participating study centres in the main study of the GNC. Strict compliance with the SOPs, thorough training of the staff and accurate documentation are mandatory to obtain high sample quality for later analyses. The so obtained biomaterials represent a valuable resource for research on infectious and other common complex diseases in the GNC.

Blood pressure components and stroke in Inner Mongolians — A prospective cohort study

Stroke is the leading cause of disability and the second-leading cause of death in the world [1]. It is becoming an ever-increasing public health burden in China [2]. There is a strong association between both systolic blood pressure (SBP) and diastolic blood pressure (DBP) and stroke, but even in cases of normal BP stroke can still occur [3]. This indicates that other risk factors and BP components other than SBP or DBP may play a role in the development of stroke. In addition to SBP and DBP, BP is also characterized by pulse pressure (PP) and mean arterial pressure (MAP). It is notable that the effect of BP components on stroke is controversial and studies are limited in Inner Mongolians. As a result, we sought to analyze the relationship between BP components and stroke in a cohort of Inner Mongolians. This prospective cohort study was conducted from June 2002 to July 2012 in Inner Mongolia, China. After obtaining approval from the Soochow University Ethics Committee, informed, written consent was received from 2589 participants. At baseline examination, participants underwent a physical examination, anthropometry, BP determination, and phlebotomy for vascular risk factors. Up to 2012, 2583 individuals (99.8%) were successfully contacted and who provided comprehensive health information. Additional details on the methods of study participant recruitment and baseline data collection have been detailed elsewhere [4]. For our analysis, stroke incidence during the follow-up period is the primary study outcome. Stroke was defined as the sudden onset of neurological symptoms lasting ≥24 h or by using a cranial computed tomography or magnetic resonance imaging examination [5]. Participants who did not have a stroke, died from other causes, or were lost to follow-up were defined as censored. Trained staff interviewed either the participants or their relatives every two years to find new stroke cases. When a new case was found during follow-up, the staff reviewed the hospital records and completed a standard event form. The questionnaires were sent to a professional review board to determine the participants' stroke diagnosis. In our cohort, there was a total follow-up time of 23,292 person–years; 124 (76 ischemic stroke, 46 hemorrhagic stroke and 2 unknown subtype stroke) individuals developed stroke. Notably, participants who developed stroke had higher BP levels for all components compared to those who did not develop stroke. As shown in Table 1, SBP, DBP, PP and MAP were all significantly associated with an increased risk for stroke, as well as ischemic and hemorrhagic stroke. As shown in Fig. 1, SBP was significantly better than DBP (P = 0.038) and PP (P = 0.005) at predicting stroke. There was no significant difference in the area under the ROC curves between SBP and MAP (P = 0.817). Similarly, SBP and MAP were also the best predictors for ischemic stroke and hemorrhagic stroke. Fig. 1 Receiver operating characteristic curves between each blood pressure component and stroke (A), ischemic stroke (B), and hemorrhagic stroke (C). Panel A shows the discriminatory value of the four blood pressure components for predicting stroke. The areas ... Table 1 Multivariate adjusted relative risk of stroke, ischemic stroke, and hemorrhagic stroke associated with each blood pressure component. The effect of BP components on stroke is controversial. According to a recent study done in a population of Chinese Han women, MAP and DBP may be slightly more informative in predicting stroke mortality [6]. Some other studies found that PP was a major determinant of stroke [7]. In our cohort of Inner Mongolians, SBP was the best predictor of stroke, which is consistent with previous researches [8,9]. MAP was also a strong predictor of stroke in our study, which confirms research conducted in a cohort of middle aged and older Asians [10]. When examining the various BP components, MAP is the steady pressure gradient that transports blood from the heart toward other peripheral tissues. Individuals with hypertension typically have higher SBP and DBP levels, so MAP is generally higher in these individuals as well. In Mongolians, increased MAP is also associated with stroke, though SBP is a slightly better predictor. These results suggest that in addition to SBP, MAP also needs to be monitored in clinical practice and in self-management of hypertension at home.