Participant Eligibility Research Articles

Eligibility and Disqualification Recommendations for Competitive Athletes With Cardiovascular Abnormalities: Task Force 6: Hypertension: A Scientific Statement from the American Heart Association and the American College of Cardiology.

An elevation of blood pressure (BP) in the systemic circulation (hypertension) is the most common cardiovascular condition in the general population and considered to be the most ubiquitous cardiovascular risk factor in competitive athletes. Competitive athletes include those athletes involved in organized sports that typically occur in schools, communities, and professional leagues, including but not limited to intramural and league sports in which medical supervision is typically required. Although most competitive athletes are between the ages of 20 and 40 years, many younger people now participate in competitive athletics. The 2013 update from the American Heart Association using the National Health and Nutrition Examination (NHANES) data from 2007 to 2010 estimates that 9.1% of men aged 20 to 34 years and 6.7% of women of that age are hypertensive, based on having an elevated BP measurement or answering “yes” to the question, “Are you taking antihypertensive medication or were you told that you had hypertension?”1 The prevalence in children and adolescents is estimated to be ≈3.5%, with higher percentages in older and obese children.2 The diagnosis of hypertension is based on the subject having an elevated BP at or above certain levels measured by routine sphygmomanometry under appropriate conditions on at least 2 separate occasions separated by at least 1 week.3 However, BP measurements in the competitive athlete are typically obtained by different healthcare providers, which makes it particularly necessary that the testing conditions be standardized before the diagnosis of hypertension is made. People >18 years of age with a BP >140 mm Hg systolic and/or >90 mm Hg diastolic are considered to have hypertension.3 In children and adolescents, hypertension is defined as average systolic or diastolic BP levels greater than the 95th percentile for sex, age, and height; however, earlier physical maturation of the competitive athlete leaves …

Abstract A62: Psychosocial resources and needs of cancer survivors treated at a comprehensive cancer center or a minority-serving institution

Abstract There are more than 13.7 million cancer survivors in the United States and this number is expected to grow to 18 million by 2020 because of improved outcomes from care and the aging of the population. Although cancer health disparities are well-described for incidence, diagnosis, and treatment, little is known about qualitative disparities among long-term survivors. At Vanderbilt-Ingram Cancer Center (VICC), an NCI-designated comprehensive cancer center, and Meharry Medical College, a minority serving institutional partner, we conducted focus groups with cancer survivors as part of formative research for reducing disparities in cancer survivorship. Methods: Adult cancer survivors were recruited from the institutional tumor registry lists at VICC (n=21) and MMC (n=20). Eligibility for participation included a primary breast (female), colorectal, lung or prostate cancer (male) diagnosed during 1995-2010 with survival for a least one year since diagnosis; age >35 years at the time of diagnosis; and English speaking. Four focus groups at MMC and at VICC, one for each cancer site at both institutions, included 15/20 African Americans at MCC and 1/21 African Americans at VICC. The responses of 41 survivors to questions about their sources of information and support, stressors, coping strategies, caregiver concerns, and unmet needs were audio-recorded. Transcriptions were analyzed using Atlas.ti and narrative methodology to identify psychosocial needs and assets. Results: Information about cancer and cancer treatment was obtained from physicians and/or and family members by almost half of focus group participants, followed by the internet and print materials. The number of sources of information reported by focus group participants ranged from 0 to 5, with MCC survivors reporting they used slightly more sources of information than those from VICC. Family and friends were identified most often by survivors from both settings as sources of support during cancer treatment, followed by healthcare providers, mentioned more often by VICC focus group participants. God was mentioned more frequently at MMC as a source of support, while survivors from VICC were more likely to say they were supported by church friends. Almost half of focus group participants at both sites described a variety of lingering thoughts associated with psychosocial difficulties at diagnosis and treatment. While changes in functioning were mentioned by more than half of the focus group participants, several individuals described those changes as resolving or not stressful. Current stressors identified by focus group participants included neuropathy, incontinence or excessive urination, memory loss, hot flashes, heat and cold sensitivity, pain secondary to medication, fatigue, impotence, and respiratory difficulty. Fear of recurrence or second cancers were indicated as current stressors by just under half of the focus group participants. Next most frequently mentioned stressors were concerns about the well-being and health of partners and children, and difficult emotions, followed by financial worries (including lack of or uncertainty about insurance coverage) and stress associated with work. One survivor at MCC and four at VICC indicated they are experiencing no significant stress associated with cancer treatment or other aspects of their lives. Discussion: Given the small number of study participants, the results are useful primarily for generating hypotheses to be examined with a larger sample. They suggest that populations served in the two settings may differ in the sources of information and support they access, and the kinds of stressors they face following the end of treatment for cancer. Outcomes from this study and a needs survey study are being used to design nurse navigation interventions to improve health outcomes among survivors. Citation Format: Rebecca Selove, Maya Foster, Debra Wujcik, Maureen Sanderson, Pamela C. Hull, Dira R. Ashworth, Amaka Okafor, David Shen-Miller, Steven Wolff, Debra L. Friedman. Psychosocial resources and needs of cancer survivors treated at a comprehensive cancer center or a minority-serving institution. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr A62.

Perspectives in Implementing a Pragmatic Pediatric Primary Care-Based Intervention Trial.

The 2013 U.S. Preventive Services Task Force (USPSTF) concluded that behavioral interventions are effective in reducing initiation of smoking in youth, recommending primary care clinicians provide education or brief counseling to prevent initiation, and that there are promising trends toward behavioral interventions improving cessation in this population. Our primary care-based intervention RCT conducted between 2000 and 2004, Air It Out, informed these USPSTF recommendations. Our trial was designed to determine whether a pediatric primary care practice-based smoking prevention and cessation intervention would be effective in increasing abstinence rates among adolescents under usual clinic conditions, to inform clinical practice. Therefore, the trial was designed to be largely a pragmatic trial. In this paper, we describe where each of the Air It Out study components falls along the pragmatic-explanatory continuum regarding participant eligibility criteria, intervention and comparison condition design, follow-up and outcomes, compliance and adherence assessments, and analysis. Such an assessment assists researchers by providing a framework to guide decisions regarding study design and implementation. We then share a few principles and lessons learned in developing and implementing the primary care-based intervention trial, focusing on study setting selection, engaging providers who will be delivering the intervention and the target population who will be receiving it in designing the trial and interventions to be tested, and the need to carefully plan recruitment and retention procedures. The hope is to increase the number of well-designed studies that can be included in the evidence reviews to guide future USPSTF recommendation statements.

The study of women, infant feeding and type 2 diabetes after GDM pregnancy and growth of their offspring (SWIFT Offspring study): prospective design, methodology and baseline characteristics.

BackgroundBreastfeeding is associated with reduced risk of becoming overweight or obese later in life. Breastfed babies grow more slowly during infancy than formula-fed babies. Among offspring exposed in utero to maternal glucose intolerance, prospective data on growth during infancy have been unavailable. Thus, scientific evidence is insufficient to conclude that breastfeeding reduces the risk of obesity among the offspring of diabetic mothers (ODM).To address this gap, we devised the Study of Women, Infant Feeding and Type 2 Diabetes after GDM Pregnancy and Growth of their Offspring, also known as the SWIFT Offspring Study. This prospective, longitudinal study recruited mother-infant pairs from the SWIFT Study, a prospective study of women with recent gestational diabetes mellitus (GDM). The goal of the SWIFT Offspring Study is to determine whether breastfeeding intensity and duration, compared with formula feeding, are related to slower growth of GDM offspring during the first year life. This article details the study design, participant eligibility, data collection, and methodologies. We also describe the baseline characteristics of the GDM mother-infant pairs.MethodsThe study enrolled 466 mother-infant pairs among GDM deliveries in northern California from 2009–2011. Participants attended three in-person study exams at 6–9 weeks, 6 months and 12 months after delivery for infant anthropometry (head circumference, body weight, length, abdominal circumference and skinfold thicknesses), as well as maternal anthropometry (body weight, waist circumference and percent body fat). Mothers also completed questionnaires on health and lifestyle behaviors, including infant diet, sleep and temperament. Breastfeeding intensity and duration were assessed via several sources (diaries, telephone interviews, monthly mailings and in-person exams) from birth through the first year of life. Pregnancy course, clinical perinatal and newborn outcomes were obtained from health plan electronic medical records. Infant saliva samples were collected and stored for genetics studies.DiscussionThis large, racially and ethnically diverse cohort of GDM offspring will enable evaluation of the relationship of infant feeding to growth during infancy independent of perinatal characteristics, sociodemographics and other risk factors. The longitudinal design provides the first quantitative measures of breastfeeding intensity and duration among GDM offspring during early life.

New Measures of Economic Security and Development: Savings Goals for Short‐ and Long‐Term Economic Needs

The long‐term economic security and development of a family depend largely upon saving and asset accumulation, yet most measures of economic well‐being focus on short‐term consumption needs. In this study, we take a broader view by specifying four types of savings goals for US families: precautionary, retirement, homeownership, and education goals. This study develops methods of calculating these savings goals for different types of families under various assumptions, using information from various sources. Our calculations also consider investment gains and differences in dollar values over time. We show that families should save between $155 and $572 every month to address all four savings goals. We find that the number of children in a family affects total monthly savings goals considerably but that the number of adults has limited impact. Savings goals can assist families in making financial plans and provide savings targets useful in development of policy.

Using facebook to recruit young adult veterans: online mental health research.

BackgroundVeteran research has primarily been conducted with clinical samples and those already involved in health care systems, but much is to be learned about veterans in the community. Facebook is a novel yet largely unexplored avenue for recruiting veteran participants for epidemiological and clinical studies.ObjectiveIn this study, we utilized Facebook to recruit a sample of young adult veterans for the first phase of an online alcohol intervention study. We describe the successful Facebook recruitment process, including data collection from over 1000 veteran participants in approximately 3 weeks, procedures to verify participation eligibility, and comparison of our sample with nationally available norms.MethodsParticipants were young adult veterans aged 18-34 recruited through Facebook as part of a large study to document normative drinking behavior among a large community sample of veterans. Facebook ads were targeted toward young veterans to collect information on demographics and military characteristics, health behaviors, mental health, and health care utilization.ResultsWe obtained a sample of 1023 verified veteran participants over a period of 24 days for the advertising price of approximately US $7.05 per verified veteran participant. Our recruitment strategy yielded a sample similar to the US population of young adult veterans in most demographic areas except for race/ethnicity and previous branch of service, which when we weighted the sample on race/ethnicity and branch a sample better matched with the population data was obtained. The Facebook sample recruited veterans who were engaged in a variety of risky health behaviors such as binge drinking and marijuana use. One fourth of veterans had never since discharge been to an appointment for physical health care and about half had attended an appointment for service compensation review. Only half had attended any appointment for a mental health concern at any clinic or hospital. Despite more than half screening positive for current probable mental health disorders such as post-traumatic stress disorder, depression, anxiety, only about 1 in 3 received mental health care in the past year and only 1 in 50 received such care within the past month.ConclusionsThis work expands on the work of other studies that have examined clinical samples of veterans only and suggests Facebook can be an adequate method of obtaining samples of veterans in need of care.Trial RegistrationClinicaltrials.gov NCT02187887; http://clinicaltrials.gov/ct2/show/NCT02187887 (Archived by WebCite at http://www.webcitation.org/6YiUKRsXY).

Pulmonary function tests (PFT) results in a phase 1 (Ph1) oncology patient (pt) population.

e17759 Background: In a prior Ph1 oncology trial at our institution, 9 out of 14 patients (pts) consented were screen failures due to Grade (G) ≥ 2 PFT results, based on the Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 3. This current study was done to obtain the distribution of the PFT parameters in a typical Ph1 oncology pt population. Methods: Pts underwent a PFT according to the American Thoracic Society (ATS) consensus. Eligibility: no history (hx) of lung radiation or symptomatic lung metastases. Pts had to be non-smokers or had a smoking hx less than 10 pack-year and quit smoking > 1 year. Study objectives were to determine: 1) diffusing capacity of the lungs for carbon monoxide (DLCO) (as % of predicted) corrected for hemoglobin (DLCOc); 2) the percentage of pts who met defined PFT eligibility for Ph1 trial participation, i.e. the number of pts having DLCOc ≥ 75-90% of predicted (CTCAE v 3 Grade 1 (G1)) or normal. A 1-stage study design assumed a reference DLCO standard devia...

Short- and Long-Term Outcomes of Mental Health Court Participants by Psychiatric Diagnosis.

The goal of mental health courts (MHCs) is to decrease incarceration and recidivism while increasing continuity of mental health treatment. Although previous research has found positive outcomes, questions remain unanswered regarding the population for which MHCs work best. No studies have assessed potential differences in MHC outcomes by psychiatric diagnosis. This study filled the gap by addressing the following research question: Are there differences in short-term program outcomes and in long-term recidivism and mental health engagement outcomes by psychiatric diagnosis? The study was a cross-site evaluation of eight MHCs in a single state. To assess long-term outcomes, this study analyzed data from participants who had been discharged from an MHC for at least one year (N=234). Four diagnostic categories were used: bipolar disorder, depressive disorder, schizophrenia, and "other" disorder. Demographic, programmatic, recidivism, and mental health treatment data for each individual were collected from state administrative agencies. The findings suggest no differences by diagnosis in short-term outcomes or recidivism; however, significant reductions in use of high-intensity mental health services were noted for individuals with schizophrenia. Findings support inclusive eligibility for MHC participation across diagnostic categories and should inform policy and practice in regard to MHC development and operation. Future research should examine other key characteristics to determine ways in which resources can be best utilized.

Comorbid depression/anxiety and teeth removed: Behavioral Risk Factor Surveillance System 2010.

The purpose of this study was to examine the association between participants (i) who reported having had clinical diagnoses of depression and anxiety with 6+ teeth removed and (ii) who reported having had clinical diagnoses of depression and anxiety with edentulism. The Behavioral Risk Factor Surveillance System (BRFSS) Survey 2010 was used for the study. Analyses involved using SAS 9.3® to determine variable frequencies, Rao-Scott chi-square bivariate analyses, and Proc Surveylogistic for the logistic regressions on complex survey designs. Participants eligibility included being 18 years or older and having complete data on depression, anxiety, and number of teeth removed. There were 76 292 eligible participants; 13.4% reported an anxiety diagnosis, 16.7% reported a depression diagnosis, and 8.6% reported comorbid depression and anxiety. The adjusted logistic regression models were significant for anxiety and depression alone and in combination for 6+ teeth removed (AOR: anxiety 1.23; 95% CI: 1.10, 1.38; P = 0.0773; AOR: depression 1.23; 95% CI: 1.10, 1.37; P = 0.0275; P < 0.0001; and AOR: comorbid depression and anxiety 1.30; 95% CI: 1.14, 1.49; P = 0.0001). However, the adjusted models with edentulism as the outcome failed to reach significance. Comorbid depression and anxiety are associated independently with 6+ teeth removed compared with 0-5 teeth removed in a national study conducted in United States. Comorbid depression and anxiety were not shown to be associated with edentulism as compared with any teeth present.

Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community contexts. Method: First, we summarize existing studies with current and former prisoner samples that highlight RCT methodological techniques. Then, we introduce the trial of Support Matters and discuss obstacles and efforts to overcome those obstacles. Results and Conclusions: We focus on factors related to sampling frame, participant eligibility, sample size, engagement, and attrition. We conclude with general recommendations related to project delays, compromised research sites, and retention. This article provides guidance based on lessons learned from an RCT of a social support intervention with releasing prisoners and their loved ones. Barriers discussed and recommendations presented here will help interventionists develop and implement RCTs in prison to community contexts.

TRIALS AND TRIBULATIONS: THE STORY OF THE SAFER 2 STUDY

BackgroundThe SAFER 2 study is an RCT looking to improve the care provided by ambulance service to elderly patients who fall, by providing paramedics with a complex intervention consisting of...

Mo1062 Adenoma Prevalence and Distribution Among U.S., Puerto Ricans, and Dominicans Undergoing Screening Colonoscopy: A Prospective Cohort Study

Background: Latinos in the U.S. represent a heterogeneous amalgam of subgroups varying in genetic background, culture, and socioeconomic status. Colorectal cancer is the second leading cancer diagnosed among U.S. Latinos. Little is known about the pathological findings at screening colonoscopy (SC) among Latino subgroups. Aim: To determine the prevalence and distribution of histologically confirmed adenomas found at SC among asymptomatic, average-risk U.S.-dwelling Puerto Ricans and Dominicans. Methods: An IRB-approved prospective cohort study was conducted at an academic medical center in New York City using patient navigation to decrease barriers to SC among Latinos. Primary care physicians directly referred patients to SC from 5/2008-12/2011. Participant eligibility included asymptomatic, average-risk Latinos aged ≥ 50, without colorectal cancer screening within the past 5 years, and without significant comorbidities. Statistical analyses were performed on SC findings, characterized by the most advanced lesion on histology, and socio-demographic factors. Results: Of the 461 referrals that qualified for the patient navigation program, 392 were successfully navigated, and 314 completed their SC. Of these, 251 were Puerto Rican (n=194) or Dominican (n=57) with a mean age of 59.4 years and 73.3% women. At least one adenoma was detected in 30.9% of Puerto Ricans and 22.8% of Dominicans (p=NS). Proximal adenomas, with or without distal lesions, were present in 23.7% of Puerto Ricans and 21.1% of Dominicans (p=NS). The prevalence of advanced adenomas (size ≥ 1 cm, any villous component, high-grade dysplasia, or cancer) was 13.4% in Puerto Ricans and 7.0% in Dominicans (p=NS), and the prevalence of proximal advanced adenomas was 10.8% in Puerto Ricans and 7.0% in Dominicans (p=NS). On multivariate regression analysis (Tables), after adjusting for sex, age, nationality, language, education, and smoking status, Puerto Ricans had an increased prevalence of advanced adenomas (odds ratio [OR] 4.12; 95% confidence interval [CI] 1.04-16.42; p=0.04), and a trend toward increased prevalence of adenomas (OR 2.41; 95% CI 0.99-5.86; p=0.05) and proximal advanced adenomas (OR 3.42; 95% CI 0.83-14.10; p=0.09) compared to Dominicans. Notably, compared to English and bilingual speakers, Spanish speakers had higher rates of advanced adenomas and proximal advanced adenomas. Conclusions: Puerto Ricans had an increased prevalence of advanced adenomas and a trend toward increased prevalence of adenomas and proximal advanced adenomas compared to Dominicans. Both subgroups had high rates of neoplasia relative to rates found at SC among U.S. whites (Aliment Pharmacol Ther. 2012;35:1467). These data underscore the importance of better understanding colorectal cancer risk patterns among U.S. Latino subgroups, and promoting screening among those at higher risk.

Potentiators (specific therapies for class III and IV mutations) for cystic fibrosis.

Potentiators (specific therapies for class III and IV mutations) for cystic fibrosis.

A Multipronged, Adaptive Approach for the Recruitment of Diverse Community-Residing Elders with Memory Impairment: The MIND at Home Experience.

To provide a critical review of a multipronged recruitment approach used to identify, recruit, and enroll a diverse community-based sample of persons with memory disorders into an 18-month randomized, controlled dementia care coordination trial. Descriptive analysis of a recruitment approach comprised five strategies: community liaison ("gatekeepers") method, letters sent from trusted community organizations, display and distribution of study materials in the community, research registries, and general community outreach and engagement activities. Participants were 55 community organizations and 63 staff of community organizations in Baltimore, Maryland. Participant referral sources, eligibility, enrollment status, demographics, and loss to follow-up were tracked in a relational access database. In total, 1,275 referrals were received and 303 socioeconomically, cognitively, and racially diverse community-dwelling persons with cognitive disorders were enrolled. Most referrals came from letters sent from community organizations directly to clients on the study's behalf (39%) and referrals from community liaison organizations (29%). African American/black enrollees were most likely to come from community liaison organizations. A multipronged, adaptive approach led to the successful recruitment of diverse community-residing elders with memory impairment for an intervention trial. Key factors for success included using a range of evidence-supported outreach strategies, forming key strategic community partnerships, seeking regular stakeholder input through all research phases, and obtaining "buy-in" from community stakeholders by aligning study objectives with perceived unmet community needs.

Determining Participation Eligibility for Amusement Attractions

Amusement attraction participation eligibility requirements may be expressed in terms of age, height, weight, health condition, (dis)ability, and combinations of these, and potentially other criteria. Restrictive eligibility criteria can protect manufacturer and operator from liability for injury, since no guest could sustain injury without exposure to the ride. However, new forms of liability have emerged, through litigation under general human rights codes or specific regulations of the Americans with Disabilities Act. This paper describes and compares two approaches to more specifically determining participation eligibility for guests with disabilities and health conditions: the medical approach and the human factors engineering approach. Although many conditions are manifest in a range of severities, the medical approach will either impose the most restrictive eligibility on all guests with the same disability type, or require park personnel to make diagnostic determinations outside their expertise, and requires compilation of data about every disability and condition. The human factors engineering approach identifies functions to be performed by the guest to fulfill the ride experience. Clear description of functions and risks will enable guests to determine whether they are able to safely ride, in consultation with their own advisors. The approach to determining eligibility affects not only whether a particular guest can ride, but also operational practices that affect guests’ relationship with the park.

Incidence and correlates of HIV and syphilis in a prospective cohort of men who have sex with men in Mianyang, China, over a 36-month period.

Background Estimates for the HIV/AIDS epidemic from the China Ministry of Health show that the epidemic is spreading rapidly among men who have sex with men (MSM). Respondent-driven sampling (RDS) was adapted in 2009 and snowball sampling was adapted to supplement the number of participants in 2010 and 2011. Interviewer-administered questionnaires and blood tests were conducted to confirm enrolment eligibility of participants. A total of 725 HIV-negative participants were included into the cohort study. The cohort had a HIV incidence density of 5.6 (95% CI: 3.9-7.3)/100 person-years (PY) and a syphilis incidence density of 5.6 (95% CI:3.7-7.6)/100 PY. Age ≤20 years (21-25 years, hazard ratio (HR)=0.32, 95%CI: 0.11-0.95/≥26 years, HR=0.17, 95%CI: 0.05-0.66), having not participated in peer education in the past year (HR=2.96, 95%CI: 1.19-7.35), seeking male sexual partners in a public washroom/park (HR=3.61, 95%CI: 1.03-12.47), being currently infected with syphilis (HR=3.21, 95%CI: 1.31-7.91), having sex partners aged ≥30 years (HR=3.40, 95%CI: 1.11-10.39) and having more than four male sexual partners within the past 6 months (HR=3.34, 95%CI: 1.24-9.04) were found to be risk factors for HIV seroconversion (each P<0.05). Being married (HR=2.38, 95%CI: 1.04-5.46), having not participated in peer education in the past year (HR=2.28, 95%CI: 1.08-4.82), having limited HIV/AIDS knowledge (HR=4.28, 95%CI: 1.94-9.43) and having a sexually transmitted disease infection in the past 6 months (HR=4.74, 95%CI: 1.83-12.30) were identified as factors for syphilis infection (each P<0.05). The incidence rates of HIV and syphilis in Mianyang City reamained high in the cohort of MSM for 36 months. Increased attention should be given to this serious epidemic, and appropriate interventions should be implemented to address MSM-specific issues in order to prevent HIV and syphilis infection in China.

Imaging atlas for eligibility and on-study safety of potential knee adverse events in anti-NGF studies (Part 1)

Monoclonal antibodies that bind and inhibit nerve growth factor (NGF) have demonstrated both, good analgesic efficacy and improvement in function in patients with osteoarthritis (OA). Despite initial promising data, trials in OA had been suspended by the Federal Food and Drug Administration (FDA) due to concerns over accelerated rates of OA progression. Imaging will play a crucial role in future clinical trials to define eligibility of potential participants and to monitor safety during the course of these studies. This will require baseline and frequent follow-up radiographs of both, the index joints and other large weight bearing joints to identify subjects at risk prior inclusion and on study so treatment can be discontinued. This imaging overview in the form of an atlas describes and illustrates potential exclusionary joint imaging findings at eligibility and potential adverse joint events on radiography and magnetic resonance imaging (MRI) in studies investigating a-NGF compounds. The overarching goal of this atlas is to facilitate trial design and to promote a common language and understanding between potential expert readers. This first section of the atlas will focus on knee joint specific findings that are relevant to a-NGF studies.

Strategies to influence attitudes towards pharmacotherapies for alcohol and opioid use disorders

Clinical Trials Network 0019 (CTN 0019) (Tross et al., 2008). The CTN 0019 protocol was a multi-site randomized clinical trial that assessed the intervention of Safer Sex Skills Building (SSSB) in women substance abusers on reducing HIV sexual risk. The current study consists of 124 AA women from the CTN 0019 dataset. Participation eligibility required women to be at least 18 years of age, proficient in English, enrolled in substance abuse treatment, and to acknowledge unprotected heterosexual intercourse within the past 6 months. Results: In the current sample, 70.2% (N=87) endorsed lifetime physical abuse from a male sexual partner. Of the women experiencing physical abuse, 33.3% (N=29) reported physical abuse from their current main partner. Independent sample t-tests showed that women who self-reported physical abuse had lower levels of SRP than those who did not (t(118) =3.18; p< .01). The moderation model of SRP decreasing the relationship between victimization and risky sexual behavior approached significance (p= .064). Conclusions: The current study is among the first to examine moderating factors of SRP in substance-abusing African American women. The findings from this study provide evidence that substance abuse interventions may benefit from activities promoting the development of sexual relationship power and self-efficacy in substance-abusing African American women who have experienced victimization. Financial support: No financial support was provided for the current study.

Evaluation of non-invasive screening measures to identify individuals with prediabetes

AimsBecause blood-based screening to identify those with prediabetes to take part in Diabetes Prevention Program (DPP) translation efforts can be costly and time-consuming, non-invasive methods are needed. The aims of this paper are to evaluate the ability of the American Diabetes Association (ADA) risk test in identifying individuals with prediabetes, as well as the use of body composition measures for this purpose. In addition the utility of these alternate methods to ascertain the presence of the metabolic syndrome was assessed. MethodsPotential participants were recruited from a worksite and three community centers to take part in a DPP translation study. Participants completed onsite screening where anthropometric measures, fasting lipids and glucose, and hemoglobin A1c were assessed. Those with a BMI ≥24kg/m2 and prediabetes and/or the metabolic syndrome were eligible to participate. Non-invasive screening methods were evaluated for their ability to identify those with prediabetes and the metabolic syndrome based on clinically measured values. ResultsAll non-invasive methods were highly sensitive (68.9% to 98.5%) in the detection of prediabetes, but specificity was low (6.7% to 44.5%). None of the alternatives evaluated achieved acceptable discrimination levels in ROC analysis. Similar results were noted in identifying the metabolic syndrome. ConclusionsThe non-invasive methods evaluated in this study effectively identify participants with prediabetes, but would also allow for enrollment of a large number of individuals who do not have prediabetes. Deciding whether to use these alternatives, blood-based measures, or a combination of both will ultimately depend on the purpose of the program and the level of flexibility regarding participant eligibility.

Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study).

BackgroundThere is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD).MethodsTwo trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis.ResultsWe obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration.ConclusionsCluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for research governance approval and intervention implementation. Pretrial data analyses should inform trial design and analysis plans.Trial registrationCurrent Controlled Trials ISRCTN 47558792 and ISRCTN 35701810 (both registered on 17 March 2010).