Interest In Study Participation Research Articles

Assessment of Adolescent and Parent Willingness to Participate in a Comparative Study of Scoliosis Braces.

Adolescents with idiopathic scoliosis (IS) are often prescribed an orthosis to prevent curve progression and avoid surgery. Standard-of-care scoliosis orthoses are designed for full-time (FT) wear, which can be burdensome for some patients. Nighttime (NT) hypercorrective scoliosis orthoses are another option that has a lower impact on daily life, however, additional research is needed to guide the prescription of NT orthoses. The aim of this study was to assess the willingness of patients with IS and their parents/guardians to enroll in a randomized controlled study on bracing in scoliosis. A cross-sectional study was conducted to survey adolescents with IS and their parents/guardians. Eligibility criteria for adolescent participants included: (1) diagnosis of IS, (2) no previous orthosis use, (3) currently seeing a provider for their scoliosis, and (4) able to communicate in English. Parent/guardian participants were the parent or guardian of an adolescent participant and were able to communicate in English. Separate online surveys were designed for adolescents and their parents/guardians. Surveys provided information about a hypothetical study and queried respondents about whether they would participate in the study, their willingness to randomize brace treatment, and their preferences for NT or FT bracing. Descriptive statistics were used to summarize survey data. One hundred four adolescent/parent dyads completed the survey (104 adolescents and 103 parents). Most participants (adolescents: 55.8%, parents: 55.3%) indicated an interest in study participation, and approximately one-third of participants (adolescents: 31.8%, parents: 30.1%) reported that they would be willing to randomize to brace type. Most participants (adolescent: 77.0%, parent: 81.6%) preferred the NT brace if they needed brace treatment. High-quality evidence is needed to inform the use of FT and NT scoliosis orthoses. Approximately a third of respondents would enroll in a randomized trial, indicating that multiple collaborative sites will be needed to recruit a sufficient sample into a randomized study on scoliosis bracing. Study findings also demonstrate support from adolescents and their parents/guardians for research on scoliosis bracing.

Dorsal Subluxation of the First Metacarpal During Thumb Flexion is an Indicator of Carpometacarpal Osteoarthritis Progression.

Dorsal Subluxation of the First Metacarpal During Thumb Flexion is an Indicator of Carpometacarpal Osteoarthritis Progression.

%PT-GSDesign: A SAS Macro for group sequential designs with time-to-event endpoint using the concept of proportional time

Sequential testing can be used to meet the specific needs of a clinical trial, all while adhering to the study's ethical, financial, and administrative considerations. When the assumption of proportional hazards or exponentially distributed lifetimes is not satisfied, the researcher can rely on the Proportional Time assumption for sample size calculation. The proportional time method has the advantage that previous study results can be used to bolster the current study design and provide an easier interpretation of the treatment benefit by reporting results as an improvement in longevity versus the more traditional interpretation of reduction in risk. This ease in interpretation of treatment benefit helps in raising interest in study participation. This novel method can be applied through a SAS macro and can be utilized for all distributions that belong to the generalized gamma family. The macro incorporates features specific to time-to-event data such as loss to follow-up, administrative censoring, differing accrual times and patterns, binding or non-binding futility rules with or without skips, and flexible alpha and beta spending functions. The macro includes validation for any parameters defined by the user, as well as suggestions for correcting erroneous input. This paper demonstrates two practical applications of the SAS macro with varying design inputs.

Trends in Human Immunodeficiency Virus and Sexually Transmitted Infection Testing Among Gay, Bisexual, and Other Men Who Have Sex With Men After Rapid Scale-up of Preexposure Prophylaxis in Victoria, Australia.

Scale-up of human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) has raised concerns regarding its impact on clinic capacity and access to HIV testing. We describe enrolment in PrEPX, a large PrEP implementation study in Victoria, Australia, and the impact of PrEP uptake and maintenance on existing health services. We describe enrolment between July 26, 2016, and March 31, 2018, and trends in HIV testing among PrEPX participating and nonparticipating gay and bisexual and other men who have sex with men (GBM) at 5 study clinics participating in a sentinel surveillance system (ACCESS). We evaluated HIV and STI testing trends using segmented linear regression across the prestudy (January 2015 to June 2016) and PrEPX study (July 2016 to March 2018) periods. There were 2,049 individuals who registered interest in study participation: 72% enrolled into the study. Study clinics enrolled participants rapidly; of 4265 people enrolled in PrEPX (98% GBM), 1000 enrolled by week 3, 88% (n = 876) of whom enrolled at ACCESS sites.Prestudy period HIV testing rates were increasing at all ACCESS sites. In the month PrEPX commenced, there was an additional 247 HIV tests among PrEPX participants (P < 0.01) and no significant change among non-PrEPX GBM (P = 0.72). Across the study period, HIV testing increased by 7.2 (P < 0.01) and 8.9 (P < 0.01) tests/month among PrEPX participants and non-PrEPX GBM, respectively. The HIV testing increased among non-PrEPX GBM at sexual health clinics (18.8 tests/month, P < 0.01) and primary care clinics (7.9 tests/month, P < 0.01). Similar trends were observed across testing for all measured STIs. Rapid PrEP scale-up is possible without a reduction in HIV testing among GBM not using PrEP.

Validation of a Simple Tool for Electronic Documentation of Behavioral Responses to Anesthesia Induction.

Anxiety and distress behaviors during anesthesia induction are associated with negative postoperative outcomes for pediatric patients. Documenting behavioral responses to induction is useful to evaluate induction quality at hospitals and to optimize future anesthetics for returning patients, but we lack a simple tool for clinical documentation. The Induction Compliance Checklist is a tool for grading induction behaviors that is well validated for research purposes, but it is not practical for routine documentation in busy clinical practice settings. The Child Induction Behavioral Assessment tool was developed to provide a simple and easy to use electronic tool for clinical documentation of induction behaviors. The aim of this study was to test the Child Induction Behavioral Assessment tool's concurrent validity with the Induction Compliance Checklist and the interrater reliability. This prospective, observational study included 384 pediatric patients undergoing anesthesia inhalation induction. Concurrent validity with the Induction Compliance Checklist and interrater reliability of the Child Induction Behavioral Assessment were evaluated. Two researchers alternated scoring the Induction Compliance Checklist. The 2 researchers independently scored the Child Induction Behavioral Assessment. The anesthesia clinician caring for the patient also independently scored the Child Induction Behavioral Assessment by completing their routine documentation in the patient's medical record. Two age groups were evaluated (ages 1-3 and 4-12 years old). Clinicians' and researchers' Child Induction Behavioral Assessment scores demonstrated a strong correlation with the Induction Compliance Checklist (P < .0001). There was an excellent agreement between the 2 researchers' Child Induction Behavioral Assessment scores for the younger and older age groups, respectively (Kappa [95% CI] = 0.97 (0.94-0.99); K = 0.94 (0.89-0.99)]. The agreement between the researchers and the 117 clinicians who documented Child Induction Behavioral Assessment assessments in the medical record was good overall (intraclass correlation coefficient = 0.70), with fair agreement with the 1- to 3-year-old patients (intraclass correlation coefficient = 0.56) and good agreement for the 4- to 12-year-old patients (intraclass correlation coefficient = 0.74). The Child Induction Behavioral Assessment scale is a simple and practical electronic tool used to document pediatric behavioral responses to anesthesia inductions. This study provides evidence of the tool's validity and reliability for inhalation inductions. Future research is needed at other hospitals to confirm validity.

Community-engaged Research with Rural Latino Adolescents: Design and Implementation Strategies to Study the Social Determinants of Health

The health of adolescents, perhaps more than in any other period of their life, is shaped by the social determinants of health (SDH). The constellation of SDH that disadvantages a specific group’s health may also make members of that population unable or unwilling to engage in health research. To build a comprehensive body of knowledge about how SDH operate within a specific social context, researchers must design studies that take into account how various vulnerabilities and oppressions may affect people’s experiences of being recruited, interviewed and retained in a study. In 2014, we initiated a prospective cohort study with Latino youth living in the agricultural area of Salinas, California. We began this study with the understanding that it was imperative to develop methodological strategies that actively addressed potential challenges in ways that were culturally responsive, community engaged and inclusive. In this article, we describe our approach to developing best practices in four key areas: 1) building community partnerships and engagement; 2) consideration of staffing and staff support; 3) engaging youth’s perspectives; and 4) developing culturally appropriate research protocols. In our sample of 599 participants, nearly all youth identify as Latinx (94 per cent), half (49 per cent) have at least one parent employed as a farmworker, 60 per cent reside in crowded housing conditions, and 42 per cent have mothers who did not complete high school. Given these multiple vulnerabilities, we view a robust number of youth expressing interest in study participation, the willingness of their parents to permit their children to be enrolled, and the achievement of an ambitious sample target as evidence that our efforts to undertake best practices in community-engaged and inclusive research were well received.

Implementation of nasal naloxone across health-care settings: a case report from Ohio

Drug overdose is now the leading cause of injury death in the United States, surpassing deaths from motor vehicle accidents in 2008 [1]. Naloxone, a short-acting mu opioid receptor antagonist, can reverse an opioid overdose and prevent fatality [2]. Opioid overdose prevention programs (OOPPs) provide education on overdose prevention and some have begun to distribute naloxone. As of June 2010, there were an estimated 188 OOPPs operating in the United States [3]; despite the fact that Ohio has one of the highest overdose fatality rates, there were no OOPPs at that time. The purpose of this study is to: 1) describe overdose prevention education and/or naloxone distribution programs in Ohio across various health-care settings; and 2) identify implementation barriers. A two-page survey was emailed to known Ohio OOPPs and snowball sampling was used to identify other programs. OOPP staff were contacted by phone to confirm their interest in study participation, and 19 of 21 programs completed the survey and are included in this analysis. As of October 2014 these 19 OOPPs were operating in 14 Ohio cities. The primary funding sources were: 1) Ohio Department of Health; 2) Interact for Health (a foundation serving southwest Ohio); and 3) other local public and private agencies. Overall, these programs have distributed 1935 naloxone kits and reported 152 confirmed overdose reversals. There was significant expansion of OOPPs in Ohio after the passage of House Bill 170 in 2014, which removed criminal and civil penalties for clinicians that prescribe naloxone and bystanders that administer naloxone. Identified barriers to OOPPs include: 1) cost in terms of both the provision of naloxone kits and the operational costs associated with prescribing naloxone; 2) stigma of addiction and perceptions of naloxone as a harm reduction strategy that would enable continued drug use; 3) legal/administrative concerns related to possession and distribution of naloxone; and 4) lack of standardized protocols or models that would facilitate operational integration of OOPPs into existing programming. In conclusion, OOPPs have recently expanded significantly in Ohio. Additional research is needed to determine whether this expansion is associated with a decrease in overdose fatalities. Language: en

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting.

BackgroundRapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.MethodsMixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities.ResultsIn their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed.ConclusionThe study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended.

Assessment of Interest for Breast Cancer Prevention Trial Participation among BRCA Mutation Carriers

Purpose: BRCA1 and BRCA2 mutation carriers develop breast cancers with a tumor phenotype unique from spontaneous tumors. We surveyed known BRCA mutation carriers to determine willingness to be contacted about participation in future breast cancer prevention research studies directed to their unique phenotype. Methods: Data were collected through self-reported surveys at 3 participating institutions from women who: wereat least 20 years of age; had a documented germline, deleterious mutation in BRCA1 or BRCA2; and had no prior history of breast cancer. Survey questions related to willingness regarding possible participation in future breast cancer prevention trials, including studies that may involve breast biopsies. Survey results were summarized using descriptive statistics. Results: Among 56 BRCA1 and BRCA2 mutation carriers who responded, 55.4% of women reported high or very high interest in participating in a randomized control study of chemoprevention agent vs. placebo. Within this population, post-menopausal women demonstrated a higher interest in study participation (64.5%) versus premenopausal women (38.9%). When examining willingness to undergo breast biopsy for a chemoprevention study, women expressed near equal willingness (42.9%) and unwillingness (44.6%) for biopsy. Conclusions: BRCA1 and BRCA2 mutation carriers demonstrated significant interest in breast cancer prevention study participation involving active versus placebo agents, and an equal expression of willingness and unwillingness to undergo breast biopsy. These data should be highly informative for planning future breast cancer chemoprevention trials.

Board 339 - Research Abstract Patient Simulation for Assessment and Reinforcement of Layperson Management of Opioid Overdose with Intranasal Naloxone in a Recently Released Prison Inmate Cohort (Submission #66)

Introduction/Background Individuals who accidentally overdose (OD) with opioids, especially those recently released from prison, are at significant risk for death. Investigators initiated a program to assess, educate, equip and reassess at-risk, volunteering prison inmates in opiate OD prevention, recognition and naloxone administration for post-release exposure to OD situations. Methods Inmates expressing an interest in study participation after recruitment announcements, mailings and posters were approached for consent. Those agreeing to participate underwent a baseline assessment of OD-related knowledge, including recognition of opioid OD and awareness of naloxone. The study intervention was an educational DVD with standardized didactics; skills practice was not feasible during incarceration. Subjects were provided with an intra-nasal naloxone kit at time of release and scheduled for followup assessment. In order to evaluate subjects perception, acquisition, retention and delivery of layperson resuscitative skills for opioid OD at post-release followup, emergency medicine, simulation and substance abuse investigators developed an OD simulation script with accompanying 24 item assessment checklist for a low-fidelity full-body manikin. The scenario was designed to elicit, record and positively reinforce subjects performance of basic airway maneuvers, rescue breathing, naloxone administration, accessing of emergency services, avoidance of harmful actions and continued monitoring. Drug use props, distractor decoys (for common OD treatment errors) and ambient noise were provided. Investigators designed the simulation scenario for administration with video-recording as part of an assessment battery* that evaluated each subject soon after release. Pre-pilot sessions tested the scenario for feasibility and research utility. The study was IRB approved. *Assessments include the validated Brief Overdose Recognition and Response Assessment [BORR],1 questionnaires on OD risks, naloxone risks and perceptions of self-efficacy/confidence in pertinent knowledge and skills. Results One hundred sixty six inmates expressed an interest in study participation, of whom 99 (60%) consented to participate and completed the baseline assessment; 94 completed the study intervention training while incarcerated. Subject demographics were representative of the target population: average age 34.2 years; male 85%; race: white 81%, African American 7%, American Indian 5%, Hispanic/Latino 11%. 88 subjects received a naloxone kit. Six-month interim follow-up data were available for 40 subjects (43% of trained recruits) out of a projected cohort of 100 subjects. None of the follow-up subjects reported OD’s after release; 60% reported engaging in OD protective behaviors since release, including 3 naloxone administrations. At followup, subjects exhibited significant gains in OD recognition and response (naloxone administration) knowledge and self-efficacy scores as recorded by BORRA and questionnaires. Subjects scores on critical action checklists during simulation scenario at followup averaged 11.4±4.0 (range 3–22, out of 24 total correct actions). Average time to assemble the kit and administer intranasal naloxone was 55 seconds. Naloxone was administered IV, IM and without intra-nasal atomizer to the manikin by one participant each. Five participants incorrectly administered the naloxone (e.g., one nostril only or half the dose). Three participants stated they did not know how to put the naloxone together during the simulation; 5 individuals (12%) self-corrected themselves during the simulation. Additionally, potentially harmful interventions such as slapping, kicking or hitting the manikin were observed during 17 (46%) simulation sessions and unnecessary chest compressions were often performed. Conclusion Investigators developed and initiated an opioid OD prevention program for at-risk prison inmates, with a simulation component for hands-on demonstration of knowledge and assessment of skills at follow-up. The variation in in-simulation performance across subjects and relative to traditional assessment tools appears to support the utility of simulation as an evaluative methodology to assess layperson OD management skills. Reference 1. Green TC, Heimer R, Grau LE. Distinguishing signs of opioid overdose and indication for naloxone: an evaluation of six overdose training and naloxone distribution programs in the United States. Addiction, 2008; 103(6): 979–89. Disclosures Part-time employee of Inflexxion Inc. University Emergency Medicine Foundation (research grant 2009) intellectual property (copyrights; patent pending) on GLIDEPATH system.

Abstract C01: Assessment of interest for breast cancer prevention trial participation among BRCA mutation carriers

Abstract Purpose: BRCA1 and BRCA2 mutation carriers develop breast cancers with a tumor phenotype unique from spontaneous tumors. We surveyed documented BRCA mutation carriers to determine willingness to be contacted about participation in future breast cancer prevention research studies directed to their unique phenotype that may or may not require breast biopsies. Methods: At each of the 3 participating institutions, women at least 20 years of age with a documented germline deleterious mutation in BRCA1 or BRCA2 and no prior history of breast cancer were contacted to participate in a survey to ascertain their willingness to be contacted to participate in future prevention trials. Survey results were summarized using descriptive statistics. Results: Among 56 BRCA1 and BRCA2 mutation carriers who responded, 55.4% of women reported high or very high interest in participating in randomized control study of chemoprevention agent vs. placebo. Within this population, post-menopausal women demonstrated a higher interested in study participation (64.5%) versus pre-menopausal women (38.9%). When examining willingness to undergo breast biopsy for a chemoprevention study, women expressed near equal willingness (42.9%) and unwillingness (44.6%) for biopsy. Conclusions: BRCA1 and BRCA2 mutation carriers demonstrated significant interest in breast cancer prevention study participation involving trial agent versus placebo, and an equal expression of willingness and unwillingness to undergo breast biopsy, establishing the feasibility for future research elucidating targeted chemoprevention agents. Citation Format: Rachel M. Hurley, Vera J. Suman, Mary Daly, Funmi Olopade, Paul J. Limburg, Sandhya Pruthi. Assessment of interest for breast cancer prevention trial participation among BRCA mutation carriers. [abstract]. In: Proceedings of the Twelfth Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2013 Oct 27-30; National Harbor, MD. Philadelphia (PA): AACR; Can Prev Res 2013;6(11 Suppl): Abstract nr C01.

Enrollment in YFV Vaccine Trial: An Evaluation of Recruitment Outcomes Associated with a Randomized Controlled Double-Blind Trial of a Live Attenuated Yellow Fever Vaccine.

This investigation evaluated several factors associated with diverse participant enrollment of a clinical trial assessing safety, immunogenicity, and comparative viremia associated with administration of 17-D live, attenuated yellow fever vaccine given alone or in combination with human immune globulin. We obtained baseline participant information (e.g., sociodemographic, medical) and followed recruitment outcomes from 2005 to 2007. Of 355 potential Yellow Fever vaccine study participants, 231 cases were analyzed. Strong interest in study participation was observed among racial and ethnically diverse persons with 36.34% eligible following initial study screening, resulting in 18.75% enrollment. The percentage of white participants increased from 63.66% (prescreened sample) to 81.25% (enrollment group). The regression model was significant with white race as a predictor of enrollment (OR=2.744, 95% CI=1.415-5.320, p=0.003).In addition, persons were more likely to enroll via direct outreach and referral mechanisms compared to mass advertising (OR=2.433, 95% CI=1.102-5.369). The findings indicate that racially diverse populations can be recruited to vaccine clinical trials, yet actual enrollment may not reflect that diversity.

The Power of Videotaped Personal Statements of Patients With Lung Cancer: A Recruitment Strategy for Smoking Prevention and Cessation Programs

igarette smoking continues to be the leading cause of prevent-able morbidity and mortality in the United States (U.S. Department of Health and Human Services, 2004). Cigarette smoking causes an estimated 443,000 deaths each year, including approximately 49,400 deaths from ex-posure to secondhand smoke. In 2009, about 21% of U.S. adults were cigarette smokers; 90% of lung cancer deaths among men and approximately 80% of lung cancer deaths among women are related to smoking (National Cancer Institute, 2010). Although 70% of smok-ers report that smoking is hazardous to health (Viscusi, 1990), rates of smoking have not significantly declined and an estimated 21% of adults in the United States continue to smoke. Patients with cancer are willing to intervene with their families, and family members self-report a decrease in their smoking habits that may be a result of the occurrence of lung cancer in the family (Gerrard & Hingorani, 2001; Schilling et al., 1997). However, professed interest in study participation, unfortunately, does not ensure that family members will then participate in an intervention. The effec-tiveness of a recruitment strategy when working with patients with cancer and their families can determine the success or failure of the intervention.Krant and Johnston (1977) reported that families of patients with cancer ex-pressed feelings of tension and helpless -ness and voiced their desire of finding a way to best help the patient. McBride and Ostroff (2003) identified a cancer diagnosis as a catalyst that can person-alize the dangers of smoking, therefore directing the patient and loved ones who smoke toward restoration and mainte-nance of good health. In addition, rela-tives of patients with lung cancer who smoke were found to be more inclined to quit than were the family members of patients diagnosed with cancers other

Recruitment of Black Women for a Study of Inherited Breast Cancer Using a Cancer Registry–Based Approach

We sought to understand the factors associated with recruitment activities while conducting a registry-based study of black women found to have breast cancer <age 50 to investigate mutations in the BRCA1 and BRCA2 genes. State mandated recruitment methods included TWO mailings, followed by a telephone response card for patients who did not wish to be contacted by phone. If no response was received within 3 weeks of the second mailing, the study team contacted the patient by phone. Of the 209 eligible patients identified by the cancer registry, contact was established in 87, of whom 82 were eligible for study participation. The overall rate of interest in study participation was 80% (including 93% for those with passive follow-up and 68% for those with active follow-up), with the primary factor cited being the desire to understand more about the risk of cancer for family members. This is the first study conducted through a State Cancer Registry, in which the primary goal was to recruit participants for genetic counseling and testing for inherited breast cancer. In contrast to many prior studies, our results suggest that young black women with breast cancer are interested in participating in genetics studies.

Title: Comparison of characteristics in study participants and nonparticipants in the Louisiana Healthy Aging Study

Purpose Differences between study participants and nonparticipants are a concern in epidemiologic studies. Study results may be biased if those participating are not representative of the reference population for whom the research in question is targeted. The purpose of this study is to compare demographic characteristics of individuals who choose or refuse to participate in the Louisiana Healthy Aging Study. Methods Louisiana Healthy Aging Study is a population-based study which examines the determinants of healthy aging in adulthood in eight Louisiana parishes. The Louisiana Voter Registration File (VRF) and Medicare Beneficiary Enrollment Data Files (CMS) were used to generate sampling populations of age 20 to 64 and age 65 and older, respectively. An introductory letter with a prepaid postcard was mailed to potential participants and a follow-up letter was sent after two weeks of lag time from initial attempt. Potential subjects who did not respond to the mailing were contacted by phone to check on their potential interest in study participation. Chi-square test and logistic regression were used to determine what factors were associated with those participating in the study. Results Overall, 1729 potential subjects have been identified. Participation rate declined with age (p Conclusion Studies involving in-clinic examination may under-represent elderly, especially those with health and physical difficulties, even transportation is offered. However, gender and race do not seem to affect the decision to participate in research studies.