Prospective Participants Research Articles

Thigh Laxity After Massive Weight Loss

The presence of excess skin after massive weight loss, particularly in the thighs, not only contributes to a negative body image but can also lead to functional deficits in mobility. In the present study, we quantified the health state utility of living with excess skin in the thighs in an attempt to objectively establish the burden on the quality of life in patients living with excess thigh skin laxity. Using visual analog scale (VAS), time trade-off (TTO), and standard gamble (SG), we compared the utility outcome scores for thigh skin excess with monocular and binocular blindness from a prospective sample of medical students and the general population. Utility scores were compared using paired t test. Linear regression was performed using age, race, and education as independent predictors of each of the utility scores. One hundred thirty-four prospective participants were enrolled during a 6-month period, and 112 participants met our inclusion criteria. The utility outcome scores for thigh lift (VAS, TTO, and SG, 0.77 ± 0.15, 0.90 ± 0.11, and 0.89 ± 0.14, respectively) were statistically different from binocular blindness (VAS, TTO, and SG, 0.37 ± 0.18, 0.70 ± 0.23, and 0.70 ± 0.26; P < 0.001), but other than VAS (0.67 ± 0.15, P < 0.001), similar to monocular blindness (TTO and SG, 0.89 ± 0.13 and 0.81 ± 0.14, respectively; P > 0.05). SG (0.89 ± 0.14 vs 0.97 ± 0.02, P = 0.003) and TTO (0.89 ± 0.11 vs 0.95 ± 0.03, P = 0.038) were different between general population and medical students, respectively, corresponding to 3.96 versus 1.80 potential years willing to be traded (P < 0.05). Additionally, SG was higher in whites versus nonwhites who were willing to take a potential 8% chance of mortality compared to 15%, respectively (P = 0.001), to achieve "perfect" health. We have objectified the utility of living with thigh deformity after massive weight loss. Our sample population if faced with the condition was willing to sacrifice a potential 3.6 years of life and potentially undergo a procedure with 11% chance of mortality to address excess thigh laxity.

Taking Culture into Account: A Maori Perspective on Visual Impairment

Jill Bevan-Brown and Taingunguru Walker There is substantial research evidence showing that ethnic culture affects how disability is perceived and managed, and that taking a person's culture into account maximizes the effectiveness of the person's education (Artiles, Kozleski, Trent, Osher, & Ortiz, 2010; Bevan-Brown, 2002; Massey University, 2002). Research on the cultural implications of visual impairment is relatively scarce, however, as are accounts of culturally appropriate provisions for students who are visually impaired and who are from ethnic minority groups. This article contributes to addressing this gap in knowledge by describing research that investigated the life experiences of persons who are visually impaired and Maori, the indigenous people of New Zealand. The study identified the general, educational, and cultural barriers faced by the participants and their suggestions for how these barriers may be overcome. Although the findings relate to a specific ethnic group, they raise issues that deserve consideration for all people who are visually impaired regardless of their ethnicity. METHODS The study involved in-depth, face-to-face interviews conducted by two researchers, both of whom are Maori. One researcher is visually impaired. Ethical approval from the Massey University Human Ethics Committee was obtained. Approval and support were also given by executive committee members of Ngati Kapo, a national provider of Maori health and disability services run by and for Maori who are visually impaired (for more information, visit: ). Participants From a list of Ngati Kapo members, purposive sampling was used to identify prospective participants in a specific geographic area. All who were approached agreed to participate, resulting in a sample of 8 men and 2 women. Of the 10 participants, 2 young men were attending secondary school, 3 were aged 20-60, and 3 were aged 60 or older; 1 woman was in her 50s, and the other was aged 76. Five participants had studied or were still studying at the tertiary level. Two of these participants studied at waananga (Maori universities), and the other three attended mainstream universities. The degree of visual impairment varied among the participants. All met the Royal New Zealand Foundation of the Blind (n.d.) criteria for registration: a visual acuity of 6/24 (20/80) in the better eye after correction or a field of view that does not exceed 20 degrees at its widest angle. One participant was totally blind, and one had low vision from birth. Data collection and analysis Although a formal questionnaire was used, the interviews were more in the nature of informal chats covering a wide range of topics introduced by the researchers and participants. The discussions focused on barriers that the participants faced, helpful services and strategies, and suggestions for improving education and services to Ma ori who are visually impaired. The interviews were approximately two hours long and were conducted in the homes of 9 participants and the workplace and home of the other participant. Five of the 10 interviews also included whanau (extended family members) who contributed information. The interviews were audiotaped and transcribed, and a thematic approach was used to analyze the data. Barriers experienced and suggestions for overcoming them were sorted into three areas: general, educational, and cultural. A compact disc (CD) that provided a record of the results of the research was sent to each participant. The results were shared with participants to give them the opportunity to provide feedback on the findings. RESULTS General barriers Nine general barriers were identified. These barriers were psychological and practical adjustments to becoming blind; difficulty in maintaining relationships and forming new ones; negative attitudes, perceptions, and the lack of understanding of visual impairment by others; problems associated with restricted mobility, such as inaccessible and costly public transportation, unhelpful bus drivers, and footpaths in disrepair; bureaucratic-related difficulties in accessing resources and services; challenges in performing activities of daily living, such as shopping, cooking, and handling money; environmental barriers; reading difficulties mainly associated with small print, such as website addresses; and financial barriers, including expensive adaptive equipment, the cost of attending rehabilitation courses, and the extra costs that employers incur when hiring people who are visually impaired--costs that can discourage them from doing so. …

Feasibility of an Interdisciplinary Early Intervention for Patients with Low Levels of Responsiveness Following an Acquired Brain Injury

There is a scarcity of research investigating interdisciplinary early rehabilitation intervention models for people with low levels of responsiveness following acquired brain injury. This is particularly problematic for service models in acute hospital settings where early rehabilitation of such patients may be assigned a low priority in comparison to other competing demands. This pilot study investigated the feasibility of implementing an interdisciplinary early rehabilitation intervention in an acute neurosciences ward within existing staffing, and describes clinical changes among intervention participants. A prospective longitudinal study, with a matched historical control (individually matched by Glasgow Coma Scale) was undertaken. Prospective intervention participants (n= 13) received up to twice-weekly interdisciplinary intervention in addition to usual care. Matched historical controls (n= 13) received only usual care. Implementing an interdisciplinary early intervention proved feasible in this acute care setting. Significant improvement (alpha = .05) among the patients receiving the interdisciplinary intervention was observed across all clinical outcomes, including: Coma Recovery Scale-Revised, Glasgow Coma Scale, Mental Status Questionnaire, Royal Brisbane Hospital Outcome Measure for Swallowing, selected subtests of the Functional Independence Measure, Acquired Brain Injury Physiotherapy Assessment and the Clinical Outcomes Variable Scale. A future randomised clinical trial is warranted.

Substitute consent practices in the face of uncertainty: a survey of Canadian researchers in aging

In Canada and elsewhere, research policies require researchers to secure consent from a legally authorized representative (LAR) for prospective participants unable to consent. Few jurisdictions, however, offer a clear legislative basis for LAR identification. We investigated Canadian researchers' practices regarding the involvement of decisionally incapacitated participants and tested whether reported practices were associated with (1) researchers' understanding of the law on third-party authorization of research and (2) their comfort with allowing a family member to consent on behalf of an incapacitated relative. We surveyed researchers in aging from four Canadian provinces about their practices with prospective participants deemed incapable of consent, their understanding of relevant law, and comfort with family consent for research purposes. Understanding and comfort were measured with research vignettes that briefly described hypothetical studies in which an adult who lacks the capacity to consent was invited to participate. Many respondents reported soliciting consent from a family member (45.7% for low-risk studies and 10.7% for serious risks studies), even in jurisdictions where such authority is uncertain at law. Researchers' tendency to solicit family consent was associated with their comfort in doing so, but not with their understanding of the law on substitute consent for research. Findings underscore the need to clarify who may authorize an incapacitated adult's participation in research. Meanwhile, people should inform their relatives of their desire to participate or not in research in the event of incapacity, given researchers' tendency to turn to family for consent, even where not supported by law.

The VA Women’s Health Practice-Based Research Network: Amplifying Women Veterans’ Voices in VA Research

The VA Women’s Health Practice-Based Research Network: Amplifying Women Veterans’ Voices in VA Research

Awareness and interest in biospecimen donation for cancer research: views from gatekeepers and prospective participants in the Latino community

Latinos are one of the fastest-growing population groups in the USA, and are underrepresented in scientific research and even more so in genetic research. The disproportionately lower number of certain subpopulations participating in biomedical research has a significant impact on the representativeness of scientific outcomes. We established a collaboration with scientists at a designated National Cancer Institute comprehensive cancer center to test the feasibility of community-based approaches for engaging Latinos in biospecimen donation for cancer genomic research. A methods triangulation approach was applied to gain a deeper understanding from the community, that included key informant interviews with Latino community leaders (N = 6), four focus groups (N = 22) with members of the Latino community, and the use of an audience response system within the focus groups to capture quantitative data. Overall, the majority of participants had never participated in biospecimen donation; however, despite being unaware of the biobank, they expressed willingness to participate as a way to help advance research. Themes included: Confusion on what biospecimen donation process entails; Barriers to and incentives for participation; Strategies and locations for reaching the Latino community. Clear communication of the "public good" as it relates to biospecimen donation by healthy/non-patient participants is a less clearly conceptualized message; yet, the significance of delivering this message is important to gaining participation and increasing the diversity of samples available for cancer genomic studies from a broader community context.

PHP53 - Successful Recruitment Strategies For Women Participation In Health Research Studies: A Meta-Analysis

To evaluate and synthesize the evidence regarding effective and efficient interventions to enhance enrollment of women into health research study. Comprehensive search done in PubMed, EBSCO, and ProQuest databases looking for studies evaluating different recruitment interventions (RI) for women participation in clinical trials/observational studies. Studies were excluded if their target population did not specifically focus on women recruitment. We estimated the frequency of RI with which women were recruited by pooling across studies that presented data for RI used to enhance participation in HRS as proportions and 95% confidence intervals (CIs) for each RI using random-effects model. STATA (version 11.0) was used to perform the analysis. We analyzed 15 interventional studies (n=9266) and 5 observational studies (n=2536). RI were classified into four categories; Referral, Social marketing (SM), health system (HS) and community outreach (CO). SM used in 96%, referrals 77%, CO in 50% and HS 88% studies. In aggregate, SM lead to 63.9%(63–64.7), referrals 14.5% (13–15.2), CO 20%(19–22), and HS 13.6% (13–14.7) participant recruitment. SM was the most effective RI in 69% (14 of 20) of studies it was attempted. This study found that social marketing as most effective strategy in the studies it attempted compared to other intervention.The identification of such RI to enhance participation in HRS should help researchers to develop strategies that will keep to a maximum participation and cooperation in HRS, while informing and protecting prospective participants adequately.

Long‐term effect of selective dorsal rhizotomy on gross motor function in ambulant children with spastic bilateral cerebral palsy, compared with reference centiles

The aim of this study was to evaluate the long-term effect of selective dorsal rhizotomy (SDR) on the gross motor function of ambulant children with spastic bilateral cerebral palsy (CP), compared with reference centiles. The study used a prospective cohort design and participants comprised 29 children classified using the Gross Motor Function Classification System (GMFCS) in level I (n=7), II (n=4), or III (n=18; 18 males, 11 females; median age at time of surgery 6 y 4 mo; range 2 y 10 mo-12 y 1 mo), who were examined 5 years and 10 years after SDR. We used individual centiles based on Gross Motor Function Measure (GMFM-66) scores and age, corresponding to the GMFCS levels. Individual improvement or deterioration was defined as a change of more than 20 centiles. Side effects experienced and additional treatment received after SDR were also recorded. Five years after SDR, 10 out of 28 children showed improvement, and 10 years after SDR 6 out of 20 children had improved. Spinal side effects were noted in two children and hip subluxation in three. Additional treatments included subtalar arthrodesis (n=13), endorotational osteotomy of the tibia (n=5), and botulinum toxin treatment (n=13). None of the children showed deterioration of gross motor function based on centile ranking. Five and 10 years after SDR, gross motor function in some children had improved more than would have been expected according to the reference centiles. This suggests, taking the limitations of this study into account, that the applied criteria for selection were adequate. However, the children still required additional treatment after SDR.

Catalog of Canadian Fitness Screening Protocols for Public Safety Occupations That Qualify as a Bona Fide Occupational Requirement

The purpose of this paper was to provide succinct descriptions of prominent job-specific physical fitness protocols (JSPFPs) that were constructed to satisfy the legal obligations to qualify as a bona fide occupational requirement for physically demanding public safety occupations. The intent of a JSPFP is to determine whether an applicant or incumbent possesses the necessary physical capabilities to safely and efficiently perform the critical on-the-job tasks encountered in a physically demanding occupation. The JSPFP information summarized in this report is accessible in full detail in the public domain. Therefore, prospective JSPFP participants and fitness professionals who require the information to train participants can fully inform themselves about the specific protocol requirements and associated fitness training implications.

English

INTRODUCTION: Performance evaluation of any learning – teaching activity by the students is routine exercise at most of the international institutions for higher education. Some speakers prefer to evaluate their own skills by giving pre-designed set of questions to the prospective participants for their own record and further improvement. Here, we have tried to evaluate overall performance of a CME programme as conceived by the participants. The reasons for doing so were many folds. Firstly, the topic of CME was out of context to medical curriculum and it was sensitive too. Secondly, there were no incentives for the participants to attend the programme other than CME theme i.e. no MMC credit hours, no gifts, no food but only a certificate of participation. Lastly, during the planning of CME programme, doubts were expressed by some of the college authorities as regard to success of CME. All these prompted us to seek first hand information from the participants regarding their views on CME topic, speakers and academic content. MATERIAL & METHODS: This was a questionnaire based evaluation. All three resident doctors under the guidance of CME faculty prepared a set of questions to evaluate CME performance in respect of the topic, the speakers and overall assessment of entire activity. The questions were prepared accordingly and pilot tested in some volunteers. Each question had five options ranging from strongly agreed to strongly disagree. Result was expressed in term of percentage response in either ‘agree’ or ‘disagree category’. RESULTS: The response of participants to CME activity was unexpectedly overwhelming. Almost, 85 to 95% of participants liked the topic. All the speakers were highly appreciated for their presentation and knowledge. Nearly 95% of the participants opined favourably to overall success of CME. CONCLUSIONS: From the results, it can be concluded that there was overwhelming response from the participants to this CME activity. More such CMEs may be planned in future without fear of any controversy.

American Indian Cultures: How CBPR Illuminated Intertribal Cultural Elements Fundamental to an Adaptation Effort

The ever-increasing numbers of ethnic minority populations in the USA seeking social services suggest that a "multicultural paradigm shift" is underway and gaining speed. This shift will increasingly demand that prevention programs and interventions be more culturally responsive. Interventions that are not aligned with prospective participants' world views and experiences are only minimally effective. Existing models for conducting culturally grounded program adaptations emphasize identifying distinct levels of cultural influences while preserving core elements of the original intervention. An effective adaptation requires competent language translation as well as trained translations of program concepts and principles that will be meaningful to the targeted group, without compromising program fidelity. This article describes how a university research team and curriculum developers worked with American Indian youth and adults in a large southwestern city using a CBPR process to identify cultural elements that became foundational to the adaptation of a prevention curriculum that is a national model program, with the objective of increasing its applicability for urban native youth.

It’s plain and simple: transparency is good for science and in the public interest

In the past couple of years, there has been a growing focus on the need to make scientific output accessible to a greater number of people, especially in the field of clinical research. The public are being urged to become more well-informed and to ask their doctors about taking part in clinical trials.A key finding of a report from the Association of Medical Research Charities was that all published scientific papers would benefit from having a section in plain English. Researchers running a clinical trial are expected to provide a summary of their intended research at various stages of the research process. However, there is evidence that existing summaries are of variable length and quality and not always in plain English.As a result, the National Institute for Health Research (NIHR) commissioned a review of the guidance that is available to researchers. However, recent initiatives demonstrate that there are still a number of challenges in making current research both accessible and understandable by prospective participants.BioMed Central also has a number of ongoing initiatives involving trial registration services and journals.

Quality of life of patients with implant-retained maxillofacial prostheses: A prospective and retrospective study

Clinical studies on implant-retained maxillofacial prostheses have focused on biological outcomes. An assessment of the effect of prostheses on patients' quality of life (QOL) by using specific questionnaires developed for this patient population provides important information on treatment outcomes from the patients' perspectives. The purpose of this study was to report patient-based outcomes of implant-retained maxillofacial prostheses and to evaluate the effect of implant-retained maxillofacial prostheses on QOL of participants in a prospective study. Eighty-two participants were treated with implant-retained maxillofacial prostheses. Participants were divided into 2 groups: a retrospective group (participants treated and under care) and a prospective group (participants willing to be treated). The posttreatment patient satisfaction scores for each question were statistically analyzed by 2-way ANOVA with variables of defect type and retention type. The Student-Newman-Keuls test was used to determine any significant differences among the groups. In the prospective group, mean scores before and after prosthetic treatment were compared with the paired t test (α=.05). The details of 54 retrospective and 28 prospective participants were reviewed. The posttreatment results of 82 patients showed that patient satisfaction with implant-retained maxillofacial prostheses was significantly different for cleaning the prostheses and recommending treatment to other people, depending on the defect and retention type. In the prospective group, participants reported significant increases in satisfaction for all questions. Implant-retained prostheses were considered highly satisfactory, indicating good QOL for patients with maxillofacial defects. A comparison of pretreatment and posttreatment assessments revealed that implant-retained maxillofacial prostheses increased patient QOL.

Acceptability and Adherence in a Chemoprevention Trial among Women at Increased Risk for Breast Cancer Attending the Modena Familial Breast and Ovarian Cancer Center (Italy)

Chemoprevention for women at risk for breast cancer has been shown to be effective, but in actual practice, women's uptake of chemoprevention has been poor. We explored factors that influence acceptability, adherence, and dropout in the International Breast (Prevention) Intervention Study during our first 3 years of activity at the Modena Familial Breast and Ovarian Cancer Center. We evaluated socio-demographic characteristics, health status, adherence, and side effect intensity. Semi-structured interviews analyzed reasons for accepting/refusing/stopping the trial. A total of 471 postmenopausal women were invited to participate, of which 319 declined to participate (68%), 137 accepted to participate (29%), and 15 participants did not make a final decision (3%). Breast cancer-related worries and trust in our preventive and surveillance programs were the most frequent reasons for accepting. Side effect-related worry was the most frequent reason for refusing. General practitioners' and family members' opinions played an important role in the decision-making process. Adherence significantly decreased after a 12-month follow-up, but it remained unchanged after 24- and 36-month follow-ups. Mild/moderate side effects reported by women did not change after 12 months of treatment. Forty percent of women withdrew from the study due to complaints of side effects. We concluded that chemoprevention trials are difficult medical experiments and that the process of deciding about whether or not to participate is based mainly on beliefs and values. This study has important clinical implications. During counselling with prospective participants, it is important to emphasize the potential benefits and to promote an informed choice. How participants make decisions, their belief systems, and their perception of risk are all factors that should be investigated in future research.

Free Spaces as Organizational Weapons of the Weak

Free spaces are arenas insulated from the control of elites in organizations and societies. A basic question is whether they incubate challenges to authority. We suggest that free spaces foster collective empowerment when they assemble large numbers of people, arouse intense emotion, trigger collective identities, and enable individuals to engage in costly collective action. We analyze challenges to authority that invite repression: mutinies of regiments in the East India Company’s Bengal Native Army in India in 1857. We take advantage of an exogenous source of variation in the availability of free spaces—religious festivals. We predict that mutinies are most likely to occur at or right after a religious festival and find that the hazard of mutiny declines with time since a festival. We expect community ties to offer alternate avenues of mobilization, such as when regiments were stationed close to the towns and villages from which they were recruited. Moreover, festivals are likely to be more potent instantiations of free spaces when regiments were exposed to an oppositional identity, such as a Christian mission. Yet even free spaces have a limited ability to trigger collective action, such as when the political opportunity structure is adverse and prospective participants are deterred by greater chances of failure. These predictions are supported by analyses of daily event-history data of mutinies in 1857, suggesting that free spaces are an organizational weapon of the weak and not a substitute for dissent.

Feasibility of Electronic Directly Observed Therapy for Pediatric Leukemia Patients

Abstract 3538 Introduction:Acute Lymphoblastic Leukemia (ALL) is the most common pediatric cancer, accounting for approximately 3000 cases per year. Although the cure rate of pediatric ALL exceeds 80% in developing countries, treatment usually lasts 2.5–3.5 years and consists of a prolonged maintenance therapy phase. This phase consists is a 20 to 32 month regimen of daily oral 6-mercaptopurine (6MP), weekly oral methotrexate, monthly intravenous vincristine, and monthly oral steroid pulses. It is estimated that non-adherence rates range from 10–40%, which increase the risk of relapse and have a negative impact on disease free survival. Prior studies show that directly observed therapy (DOT) is the most effective way to improve medication adherence, and it is widely used in anti-tuberculosis and anti-retroviral therapy. DOT is defined as a strategy for ensuring patient compliance with therapy, where a healthcare worker watches the patient swallow each dose of a prescribed medication. While DOT may be a successful strategy for pediatric ALL, cost, inconvenience, perceived intrusiveness, and stigma relating to frequent visits by healthcare workers make it less viable strategy for pediatric ALL patients. A modified version of DOT utilizes existing cellular and computer technology (Mobile DOT) to view patients taking their medications over the internet without the need for custom hardware or programming. This technique is being studied in the pediatric sickle cell population, and preliminary results show adherence rates of ≥90%. The primary aim of this study is to see if Mobile DOT is a feasible and acceptable way to monitor pediatric ALL patients’ 6MP adherence. Methods:This was a 30-day pilot study. ALL patients in their first remission were recruited if they were between 1–22 years of age, were in maintenance therapy for ≥1 month, and had daily access to a phone or computer capable of recording and submitting videos to Mobile DOT. We instructed participants how to submit the videos and they received daily reminders alerts as text messages and emails to take their medication. As adherence measures, we used direct observation and self-reported adherence using the Moriskey Medication Adherence Surveys (MMAS-4). The MMAS-4 is a validated adherence survey on a scale of 0–4, where lower scores indicate higher adherence. We measured Mobile DOT participant satisfaction with a 12 question Likert scale survey at the end of the study. Participants received a small monetary compensation for completing surveys and if they achieved ≥90% adherence for the 30 days. Results:We approached 20 prospective participants and 11 enrolled. Two subjects withdrew from the study; one was withdrawn because he was instructed to stop 6MP therapy due to myelosuppression and the other was withdrawn because his software was incompatible with our system.At enrollment, mean MMAS-4 score was 0.8 (SD ± 1.2, range 0–3), suggesting good overall adherence. By the end of study, MMAS-4 score trended toward improvement to 0.3 (SD ± 0.5, range: 0–1). Of the participants with moderate adherence (scores 2–3, n=3), all improved to good adherence (score 0–1) at the end of the study.Mean adherence measured with direct observation was 27.0/30 (SD ± 2.5 range 23–30) or 90.0% (SD ± 8.3% range 76–100%).Survey data shows that most patients (n=5) found Mobile DOT and the alerts to be helpful. Also, most participants (n=8) found that Mobile DOT took less than five minutes each day and did not invade privacy. All participants agreed that Mobile DOT was easy to use. Conclusions:This study suggests that Mobile DOT is a feasible way to monitor medication adherence in pediatric ALL patients. In addition, we found pediatric ALL patients had high adherence rates and most found Mobile DOT to be acceptable. These results suggest that Mobile DOT may be an effective strategy to ensure adequate 6MP medication adherence in pediatric ALL throughout maintenance therapy. Disclosures:No relevant conflicts of interest to declare.

Mobile Directly Observed Therapy: Monitoring and Improving Hydroxyurea Adherence in Pediatric Sickle Cell Patients

AbstractAbstract 2060Sickle cell disease (SCD) is a serious inherited red blood cell disorder that results in significant morbidity and premature mortality. Hydroxyurea (HU) is an efficacious medicine that reduces pediatric SCD complications, but poor medication adherence is common and limits effective HU utilization.Directly observing therapy (DOT) involves healthcare workers traveling to observe medication ingestion and it is a successful strategy used for anti-tuberculosis therapy. While DOT has the potential to improve adherence to chronic medications such as HU, high cost, inconvenience, and intrusiveness limit this strategy. We hypothesize that a modified version of DOT which uses mobile phones and computers (Mobile DOT), is feasible, can improve adherence, and is acceptable to patients and caregivers.Patients with SCD were eligible for this 6-month pilot study if they were 1–22 years old, prescribed HU for ≥6 months, and had daily access to a mobile phone or computer capable of recording and submitting videos.Mobile DOT participants record a daily video of their HU administrations with their phone or computer and submit these videos to a secure website for review. It does not require custom hardware or software. Participants receive automated daily reminder electronic messages. They are called to encourage adherence when needed and to provide them with technical support. Participants receive token monetary compensation when they meet adherence goals and complete surveys.To measure adherence, this study used the Morisky Medication Adherence Scale (MMAS-4, score range 0–4), the medication possession ratio (MPR) calculated from prescription refill records, laboratory markers including hemoglobin F percentage (HgbF) and mean corpuscular volume (MCV) that increase with HU therapy, and direct observation. Participants completed the Abbreviated Treatment Satisfaction for Medication survey (TSQM-9) and a 12-question survey to measure satisfaction with HU and Mobile DOT respectively.Investigators discussed this study with 19 prospective participants and 15 enrolled. Mean participant age was 13.7 years (SD ± 6.3 years, range 4–21 years). One participant withdrew because he lost computer access. Videos were approximately 10–30 seconds long and an investigator performed the observations, tracking, and phone calls in <1 hour each day. Most participants had Hemoglobin SS disease (n=11) and took HU for frequent pain crises (n=7) or acute chest syndrome (n=6).At enrollment, mean MMAS-4 score was 2.0 (SD ± 0.4), indicating moderate self- reported adherence. MPR was 67% (SD ± 26%, range 18–100%). Laboratory markers indicated good adherence (MCV>100fL and HgbF>15%) in 3 participants, moderate adherence (MCV≥90fL and HgbF>12%) in 4 participants, and poor adherence (MCV<90fL or HgbF<12%) in 7 participants. The TSQM-9 survey showed participants had 79.5% (SD ± 20.4%) global HU satisfaction rate, they felt HU was 76.2% (SD ± 22.2%) effective, and they felt taking HU was 81.7% (SD ± 16.4%) convenient.To date, all participants completed ≥30 days of the study. Direct observation showed that mean adherence was 92.1% (SD ± 0.7%, range 76–100%) at 30 days.Seven participants thus far have completed ≥2 months on study and have additional survey and laboratory data. Mean adherence in these patients was 90.5% (SD ± 6%, range 80–100%) at 60 days. MMAS-4 scores decreased from 2.1 (SD ± 0.4) to 1.3 (SD ± 1.1), suggesting improved adherence. Laboratory markers also showed improved adherence trends. Mean MCV increased from 94.3fL (SD ± 4.2fL) to 101.2fL (SD ± 8.3fL) and mean HgbF increased from 10.0% (SD ± 5.6%) to 11.3% (SD ± 4.7%). Mobile DOT surveys showed that participants found Mobile DOT easy to use, took <5 minutes each day, helped remind them to take HU, and did not invade their privacy.These results suggest that Mobile DOT is a feasible way to monitor and improve HU adherence in patients with pediatric SCD. Patients were willing to enroll on the study and surveys suggest that participants find Mobile DOT to be convenient, non-intrusive, and an acceptable. This strategy is potentially easy to disseminate because it does not include additional hardware or programming and requires minimal staff support. A larger clinical trial is needed to determine if long term Mobile DOT can impact clinical outcomes in pediatric SCD. Disclosures:No relevant conflicts of interest to declare.

Toward Improved Understanding of the Ethical and Clinical Issues Surrounding Mandatory Research Biopsies

To date, the terms of the debate, occurring within scientific meetings and the literature, have focused on the presumed scientific necessity for mandatory research biopsies versus the rights of prospective trial participants to freely consider consent to a research biopsy separately from consent to a clinical trial. Proponents argue that some important scientific questions can only be addressed by evaluation of tumor tissue from all trial participants. They claim that in the era of molecular medicine, clinical researchers frequently need to understand not just who benefits or fails to benefit from a drug, but why benefit has occurred as assessed by whether the drug reached its intended target, and whether there are molecular factors that can predict response or guide further therapy. They assume that clinical samples will be unavailable or inappropriate to address some questions, that participation rates in optional research biopsies will be inadequate, and that biopsies can be conducted safely, with informed consent, and yield meaningful knowledge to advance the field. Opponents of mandatory research biopsies do not dispute the need for research biopsies in some settings. However, they argue that linking consent to a biopsy to trial participation is at minimum unfair, and at worst coercive. Access to promising, if unproven, experimental therapy within a trial is viewed by many as an important component of quality cancer care. It is clear that patients in some settings feel that they will be harmed, through loss of access to the experimental intervention, if they fail to pursue trial care. This arguably creates a sense of coercion that violates the principle of voluntarily informed consent to the research biopsy. Further, some trial participants mistakenly assume that all aspects of trial care and procedures are intended to provide direct clinical benefit. This therapeutic misconception complicates achieving informed consent in this setting. In addition, some argue that technical limitations in our ability to conduct meaningful correlative science make requirements for universal biopsies within a trial inappropriate at this time. Achievement of evaluable molecular analysis on all patients is rareevenwhenallarerequiredtoparticipate,andevaluationofasubsetof participants can be achieved through optional biopsies. The science, according to this view, should be improved before mandatory research biopsies are considered. It should be noted that no one supports asking trial participants to undergo a biopsy for research purposes in the absence of a strong scientific rationale, meaningful informed consent, and a low to minimal risk of expected complications. In addition, there is very little, if any, debate over trials that require a biopsy to guide management within the study, such as dose of a drug or choice of intervention, termed “integral biomarker” trials. Concerns arise when the purpose of the mandatory research biopsy is correlative science, or, most controversially, when a research biopsy is planned for purely exploratory purposes or for collection for future unspecified research. Acknowledged in most of the policy statements and position papers on this subject is a relative lack of data to inform discussions of the strength of the scientific rationale used to justify inclusion of mandatory research biopsies in a protocol, the quality of informed consent, participation rates and efficiency of accrual, safety, and outcomes of the procedures. Into this relative void, and a debate that at times brings more heat than light, step Overman et al, with a welcome report on the experience with mandatory research biopsies at a single institution over a recent 5-year period. The authors conducted a retrospective analysis of clinical trials contained in the MD Anderson interventional radiology database. They identified 19 clinical trials involving mandatory research biopsies conducted for purely correlative or exploratory purposes. For these trials, they reviewed the protocol, the informed consent document, and the medical record. Overman et al found that in the trial protocols the rationale for the biopsy was inconsistently explained and a statistical plan justifying the collectionofmandatorybiopsieswasfoundinonly30%oftrials involving correlativescience.Consentdocumentswerealsoproblematic.Only40% of informed consent documents for studies using mandatory research biopsies for correlative purposes explained the research nature of the biopsy, 70% explained the scientific rationale for the biopsy, and 30% addressed biopsy safety. With regard to safety, in analysis that included trials with optional biopsies and integral biomarker studies, the investigators reported an overall complication rate of 5.2% and a major complication rate (indicating need for hospitalization or surgery) of 0.8%. When considering intrathoracic and abdominal biopsies alone the overall complication rate rose to 9.8% with a major complication rate of 1.5%. They reported no biopsy-related deaths. JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 31 NUMBER 1 JANUARY 1 2013

How do you Recruit and Retain a Prebirth Cohort? Lessons Learnt from Growing Up in New Zealand

Growing Up in New Zealand, a longitudinal study following nearly 7,000 children, has faced some unique challenges in identifying, enrolling, and retaining a large and diverse antenatal cohort. Identification of a study region with population demographics that enabled enrollment of an appropriately diverse sample was required as was intensive community and participant engagement in order to promote the study. Complementary methods used included direct engagement with prospective participants and the community and indirect engagement via media. Thus far, retention rates above 95% have been achieved by maintaining a multimethod approach that includes valuing participants and building trusting relationships, strong brand recognition, community engagement, maintenance of participant contact and location records, ensuring high-quality interactions between the participants and the study, pretesting measures and methods prior to the main cohort, and using participant feedback to inform the measures and methods used in future waves of data collection.

Educational Advantage

The goal of JERHRE is to provide empirical evidence that enables researchers and ethics committees to interpret ethical principles sensibly. The range of topics in this issue exemplifies the kinds of questions that call for empirical evidence: How to think about protecting research data from subpoena; Revised how to work with communities of stigmatized individuals; Revised how to understand and meet the needs of vulnerable pediatric populations in developing countries; Revised how to facilitate ethical decision making in the context of gaining informed consent from prospective participants in clinical trials; Revised and how to best educate students in courses on research ethics. The discussion questions posed in this article are designed to produce critical thinking among people who have read the articles in this issue. The following questions are best addressed in the context of group discussion.