Online Consent Research Articles

Impact of Lockdown due to Covid-19 on the Lifestyle Changes of Employees in India: A Cross-sectional Analysis of Personnel Who Work at Office Versus Work from Home

The nationwide lockdown implemented due to COVID-19 drastically affected the working pattern of people. Only limited staff were allowed to Work At Office (WAO) while the rest were asked to Work From Home (WFH). Employees of both the categories faced challenges due to restricted movements and safety policies. The study was planned to assess and compare the lifestyle changes of WAO and WFH employees during the lockdown. An online cross-sectional study was designed which included employees of both Government and private sectors. Electronic Data Capture method was used to collect the data after obtaining their online consent and/assent forms by circulating a web-page developed using Research Electronic Data Capture software system. Multinomial logistic regression analysis revealed that the employees of WFH were at a higher risk than WAO with respect to their food intake and eating patterns. Our analysis indicated that the risk of weight gain was higher (OR: 1.51, P < 0.005) in WFH group besides, a significant (P<0.005) increase in time spent on mobile by the WFH. An increase in the intake of fruits and vegetables was observed in both the groups. The study highlights the need for awareness on timely eating habits and minimal use of gadgets while working from home. Encouraging periodic rotation of the staff will facilitate a balanced lifestyle among working personnel. Fitness programmes may be made for the WFH staffs, especially to the younger employees to avoid the risk of obesity.

Abstract PD8-01: The metastatic breast cancer project: Generating the clinical and genomic landscape of metastatic breast cancer through patient-partnered research

Abstract Background: The Metastatic Breast Cancer Project (MBCproject) is a research study that directly engages patients (pts) through social media and advocacy groups, and empowers them to share their samples, clinical information, and experiences. The goal is to create a publicly available dataset of linked genomic, clinical, and pt-reported data to enable research. Methods: In collaboration with pts, advocates, and advocacy groups, a website (MBCproject.org) was developed that allows pts with metastatic breast cancer (MBC) anywhere in the U.S. or Canada to register. Registered pts are sent an online consent form that asks for permission to obtain and analyze their medical records and samples. Once enrolled, pts are sent a saliva kit and a blood kit and asked to mail back a saliva sample, which is used to extract germline DNA, and/or a blood sample, which is used to extract germline DNA and cell free DNA (cfDNA). We contact participants’ medical providers and obtain medical records and a portion of their stored tumor biopsies. Whole exome sequencing (WES) is performed on tumor DNA, germline DNA, and cfDNA; transcriptome sequencing (RNA-seq) is performed on tumor RNA. Medical records and pt-reported data are abstracted to create a detailed clinical record for each pt. All de-identified data are shared regularly via public databases (cbioportal.org, mbcproject.org, dbGaP, NCI Genomic Data Commons) without restrictions. Study updates are shared with participants regularly. Results: From 10/20/15-7/8/19, 5357 women and men with MBC registered. 3290 pts receiving care at over 1700 different institutions consented to share medical records and tumor/saliva/blood samples, and to have genomic analysis performed. Details of clinical data collection, biospecimen acquisition, and genomic data generation to date are outlined in the Table. WES from 463 tumors obtained from 326 pts have been generated (with matched germline WES), including 61 pts with 2 timepoints, 19 pts w 3 timepoints, and 11 pts w 4+ timepoints. 278 tumor exomes were from the breast/regional lymph nodes, 63 from distant metastatic sites and 122 from cfDNA. 110 tumor exomes were from samples obtained before the diagnosis of MBC, 258 from after the diagnosis of MBC, and 95 to be determined (TBD). 161 tumor exomes were obtained prior to any therapy, 204 following some therapy, and 98 TBD. Clinically annotated genomic data are used to study specific pt cohorts (including rare subsets and outliers) and to identify mechanisms of response and resistance to therapies. Examples of the clinical and genomic analyses that will be presented include: - Pts diagnosed <40 yrs of age (1108 pts enrolled; 120 with tumor WES) - de novo MBC (1122 pts enrolled; 121 with tumor WES) - Late recurrence, >5 yrs after diagnosis (830 pts enrolled; 77 with tumor WES) - Long-term survivors, >10 yrs with MBC (159 pts enrolled; 11 with tumor WES) - Resistance to CDK4/6 inhibitors (709 pts enrolled; 148 with tumor WES) Conclusions: Partnering directly with pts enables rapid identification of thousands of pts willing to share tumors, blood, saliva, and medical records to accelerate research. This approach allows for identification of patients with specific phenotypes, who have been challenging to identify with traditional approaches. Remote acquisition of medical records and saliva/blood/tumor samples is feasible. This clinically annotated dataset is a shared resource for the research community. Table 1Clinical data collection, biospecimen acquisition, and genomic data generation:NumberConsent signed3290 ptsSurvey #1 submitted3290 pts(demographics, diagnosis details, receptor status, clinical experiences)Survey #2 submitted1435 pts(pathology details, sites of metastasis, treatments with start and stop dates)Medical record received1307 ptsSaliva sample received1976 ptsBlood sample received1121 ptsTumor samples received482 tumor samples from 346 ptsDigital image of tumor slide H&E generated482 tumor samplesWES from germline complete310 germline samplesWES from tumor sample complete341 tumor samplesRNA-seq from tumor sample complete229 tumor samplesULP-WGS from cfDNA complete947 blood samplesWES from circulating tumor DNA complete122 blood samples Citation Format: Nikhil Wagle, Corrie Painter, Elana Anastasio, Michael Dunphy, Mary McGillicuddy, Esha Jain, Tania G Hernandez, Sara Balch, Beena Thomas, Dewey Kim, Alyssa L. Damon, Shahrayz Shah, Brett N. Tomson, Rachel Stoddard, Colleen Nguyen, Jorge Buendia-Buendia, Ofir Cohen, Jorge Gomez Tejeda Zanudo, Netsanet Tsegai, Lauren Sterlin, Ulcha Fergie Ulysse, Kathryn Sine, Oyin Alao, Jacqueline Lucia, Eric S. Lander, Todd R. Golub. The metastatic breast cancer project: Generating the clinical and genomic landscape of metastatic breast cancer through patient-partnered research [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr PD8-01.

A cross sectional study on the immediate response and mental health of the people during the initial phase of covid-19 lockdown in Chennai

Introduction: On 24th March 2020, a 21-day nationwide lockdown was announced by the prime minister of India. This was a beginning of more phases of lockdown. People had to stay indoors, with worries about an uncertain future, about the well-being of near and dear, the lockdown added to the stress of the pandemic. Aims and Objectives: Our study aims at finding out the responses of the residents of Chennai in the immediate aftermath of the initial 21-day lockdown and to assess their mental health at that time. Materials and Methods: The study design was cross-sectional with a sample of 800. An online questionnaire was created using Google forms and was circulated via social media platforms. Post online consent, the participants filled up the questionnaire which included two psychiatric scales: ADNM-20 and HADS. IBM SPSS Software version 25 was used for analysing data. Results: Out of the total 800, 215(26.84%) participants had adjustment disorder, 109(13.6%) had anxiety and 50(6.24%) had depression. Significant mean difference was observed between males and females in the scores ADNM20 (t= 81.5, p= 0.0290), ANXIETY (t= 27.5, p=0.010), DEPRESSION (t= 25.9, p=0.039). For occupations, a significant group difference was on ANXIETY scale (F= 2.427, p= 0.047) and DEPRESSION scale (F= 3.994, p=0.003). A significant group difference was observed in adjustment (F= 2.973, p= 0.019) and anxiety (F= 2.786, P= 0.026) for time spent on watching corona news. Financial worries showed a significant association with adjustment (chi =28.128, p= 0.0001), anxiety (chi= 50.252, p=0.0001) and depression (chi = 16.661, p= 0.002). A significant association was found). A significant association was found between participants picking a fight with a family members and adjustment disorder (chi =64.328, p= 0.0001), anxiety (chi= 78.089, p= 0.0001) and depression (chi= 54.667, p= 0.0001). Conclusion: This study findings will prompt the policymakers, to intervene and prioritize mental health resourc

Sunlight alone is not a disinfectant: Consent and the futility of opening Big Data black boxes (without assistance)

In our attempts to achieve privacy and reputation deliverables, advocating for service providers and other data managers to open Big Data black boxes and be more transparent about consent processes, algorithmic details, and data practice is easy. Moving from this call to meaningful forms of transparency, where the Big Data details are available, useful, and manageable is more difficult. Most challenging is moving from that difficult task of meaningful transparency to the seemingly impossible scenario of achieving, consistently and ubiquitously, meaningful forms of consent, where individuals are aware of data practices and implications, understand these realities, and agree to them as well. This commentary unpacks these concerns in the online consent context. It emphasizes that self-governance fallacy pervades current approaches to achieving digital forms of privacy, exemplified by the assertion that transparency and information access alone are enough to help individuals achieve privacy and reputation protections.

Results of the feasibility phase of the managed activity graded exercise in teenagers and pre-adolescents (MAGENTA) randomised controlled trial of treatments for chronic fatigue syndrome/myalgic encephalomyelitis

BackgroundChronic fatigue syndrome (CFS) also known as myalgic encephalomyelitis (ME) is relatively common in young people and causes significant disability. Graded exercise therapy (GET) and activity management are recommended by the National Institute for Health and Care Excellence (NICE) despite a limited evidence-base for either treatment in paediatric CFS/ME. This paper reports on feasibility and acceptability measures from the feasibility phase of the ongoing MAGENTA randomised controlled trial (RCT) investigating GET versus activity management for young people with CFS/ME.MethodsSetting: Three specialist secondary care National Health Service (NHS) Paediatric CFS/ME services (Bath, Cambridge and Newcastle).Participants: Young people aged 8–17 years with a diagnosis of mild to moderate CFS/ME. Young people were excluded if they were severely affected, referred to cognitive behavioural therapy (CBT) at initial assessment or unable to attend clinical sessions.Interventions: GET and activity management delivered by physiotherapists, occupational therapists, nurses and psychologists. Families and clinicians decided the number (typically 8–12) and frequency of appointments (typically every 2–6 weeks).Outcome Measures: Recruitment and follow-up statistics. We used integrated qualitative methodology to explore the feasibility and acceptability of the trial processes and the interventions.Results80/161 (49.7%) of eligible young people were recruited at two sites between September 2015 and August 2016, indicating recruitment to the trial was feasible. Most recruitment (78/80; 97.5%) took place at one centre. Recruitment consultations, online consent and interventions were acceptable, with less than 10% in each arm discontinuing trial treatment. Response rate to the primary outcome (the SF36-PFS at 6 months) was 91.4%. Recruitment, treatment and data collection were not feasible at one centre. The site was withdrawn from the study.In response to data collected, we optimised trial processes including using Skype for recruitment discussions; adapting recruiter training to improve recruitment discussions; amending the accelerometer information leaflets; shortening the resource use questionnaires; and offering interventions via Skype. These amendments have been incorporated into the full trial protocol.ConclusionsConducting an RCT investigating GET versus activity management is feasible and acceptable for young people with CFS/ME.Trial registrationISRCTN23962803 https://doi.org/10.1186/ISRCTN23962803, date of registration: 03 September 2015

Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study

BackgroundEthical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals.MethodsThis is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review.ResultsA total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P < 0.05).ConclusionThe reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.

Is there respectful maternity care in Poland? Women\u2019s views about care during labor and birth

BackgroundAbuse against women in labor starts with subtle forms of discrimination that can turn into overt violence. Therefore it is crucial to work towards prevention and elimination of disrespect and ill-treatment in medical facility perinatal care in which staff allows such abuse.The aim of the study was to analyze the experiences of women related to perinatal care. Special emphasis was put on experiences that had traits indicating disrespectful and offensive care during childbirth in medical facilities providing perinatal care.MethodsThis was a cross-sectional survey. A questionnaire was prepared for respondents who gave birth in medical facilities. Information about the study was posted on the website of a non-governmental foundation dealing with projects aimed at improving perinatal care. The respondents gave online consent for processing the submitted data. 8378 questionnaires were submitted. The study was carried out between February 06 and March 20, 2018. The results were analyzed using the Chi-square independence test. The analysis was carried out at the significance level of 0.05 in Excel, R and SPSS.ResultsDuring their hospital stay, 81% of women in the study experienced violence or abuse from medical staff on at least one occasion. The most common abuse was having medical procedures without prior consent. Inappropriate comments made by staff related to their own or a woman’s situation were reported in 25% of situations, whilst 20% of women experienced nonchalant treatment. In the study 19.3% of women reported that the staff did not properly care for their intimacy and 1.7% of the respondents said that the worst treatment was related to feeling anonymous in the hospital.ConclusionsThe study shows that during Polish perinatal care women experience disrespectful and abusive care. Most abuse and disrespect involved violation of the right to privacy, the right to information, the right to equal treatment, and the right to freedom from violence. The low awareness of abuses and complaints reported in the study may result from women’s ignorance about relevant laws related to human rights.

Access to an online video enhances the consent process, increases knowledge, and decreases anxiety of caregivers with children scheduled for inguinal hernia repair: A randomized controlled study

BackgroundThere is limited time within the clinical workflow of most pediatric surgeons to obtain a comprehensive, well informed consent. This study evaluates whether ad-lib access to an online video on the consent dialogue enhances the consent process for inguinal hernia repair (IHR) in children. MethodsThe study was approved by the state ethics board. A 6-min video of a consent speech on IHR was produced and uploaded to a nonpublic online channel, explaining the condition, procedure, complications, and postoperative expectations. A total of 50 families were randomized to conventional, face-to-face consenting in clinic either with (intervention) or without (control) access to the online video. During their child's IHR, the parents were asked to complete the State–Trait–Anxiety Inventory (STAI), a modified Friedlander questionnaire on assessing knowledge sufficient to provide informed consent, and a validated satisfaction survey. Scores of the intervention and control group were statistically compared. ResultsThe intervention group demonstrated significantly decreased anxiety measured with the STAI (p = 0,026) and increased knowledge (p = 0,016) compared to controls. There was no difference in satisfaction (p = 0,557). ConclusionPreoperatively providing access to an online consent video regarding IHR reduces anxiety and enhances knowledge without altering satisfaction level. Adjunct online videos are a useful tool to enhance the consent process. Type of studyProspective randomized controlled trial. Level of evidenceLevel I.

Retrospective Evaluation of an Online Diabetes Health Coaching Program: A Pilot Study.

An estimated one third of American adults have prediabetes; over 30 million have type 2 diabetes mellitus. Health and wellness coaching is an emerging tool for preventing and treating chronic disease. Mastering Diabetes (MD) promotes a low-fat, plant-based, whole-food diet, utilizing online education, day-to-day accountability and support, and video conferencing. This pilot study provides a retrospective view of the effectiveness of MD to treat diabetes. Current and former clients of MD were invited to participate in a survey. On completion of the online consent, subjects were asked a series of questions in a REDCap-based survey: age, gender, enrollment date in MD, changes in weight, HbA1c, medication use, overall health, and current level of adherence to achieved changes. Overall, 253 (8.9%) participants responded to the survey; 80.6% were females, mean age was 56 years. Most of those responding (78.4%, P < .001) reported weight loss; 68.8% (P < .001) reported decreased HbA1c; 52.4% reported decreased medication use; 86.8% reported continued health improvement since having participated in MD; and 83.5% found the online program very helpful. This study demonstrated improvement in HbA1c and weight in participants in an online health and wellness coaching. Study limitations prevent drawing generalizable conclusions; further prospective evaluation is needed.

Automated Voice Biomarkers for Depression Symptoms Using an Online Cross-Sectional Data Collection Initiative

Importance: Depression is an illness affecting a large percentage of the world's population throughout the lifetime. To date, there is no available biomarker for depression and detection and tracking of symptoms relies on patient self-report. Objective: To explore and validate features extracted from recorded voice samples of depressed subjects as digital biomarkers for suicidality, psychomotor retardation, and depression severity. Design: We conducted a cross-sectional study over the course of 12 months using a frequently visited web form version of the PHQ9 hosted by Mental Health America (MHA) to ask subjects for anonymous voice samples via a separate web form hosted by NeuroLex Laboratories. Subjects were asked to provide demographics, answers to the PHQ9, and two voice samples. Setting: Online only. Participants: Users of the MHA website. Main Outcomes and Measures: Performance of statistical models using extracted voice features to predict psychomotor retardation, suicidality, and depression severity as indicated by the PHQ9. Results: Voice features extracted from recorded audio of depressed subjects were able to predict PHQ9 question 9 and total scores with an area under the curve of 0.85 and a mean absolute error of 4.7, respectively. Psychomotor retardation prediction was less powerful with an area under the curve of 0.61. Conclusion and Relevance: Automated voice analysis using short recordings of patient speech may be used to augment depression screen and symptom management. Funding Statement: Funding for this study was provided by NeuroLex Laboratories, Inc. Funding supported study staff time only and there were no honoraria provided to participants. Our study partner, Mental Health America, provided depression survey and demographic data in addition to directing users to the voice survey. Declaration of Interests: The authors have no conflicts to disclose except for: Dr. Hosseini Ghomi is a stockholder of NeuroLex Laboratories, Inc. Ethics Approval Statement: Ethical oversight of the study was provided by the Western Institutional Review Board (WIRB #1174369). Subjects who participated were required to complete an online consent process.

Perceived usefulness of receiving a potential smoking cessation intervention via mobile phones among smokers in Indonesia

Background: The use of technology to support healthcare in Indonesia holds new promise in light of decreasing costs of owning mobile devices and ease of access to internet. However, it is necessary to assess end-user perceptions regarding mobile health interventions prior to its implementation. This would throw light on the acceptability of mobile phone communication in bringing about behavioral changes among the target Indonesian population. The aim of this study was to explore the perceived usefulness of receiving a potential smoking cessation intervention via mobile phones. Methods: This is an exploratory cross-sectional study involving current and former adult tobacco smokers residing in Indonesia. Online advertisement and snowballing were used to recruit respondents. Data was collected using a web-based survey over a period of 4 weeks. Those willing to participate signed an online consent and were subsequently directed to the online questionnaire that obtained demographics, tobacco usage patterns, perceived usefulness of a mobile phone smoking cessation application and its design. Results: A total of 161 people who smoked tobacco responded to the online survey. The mean age of the participants was 29.4. Of the 123 respondents, 102 were men. Prior experience with using a mobile phone for health communication (OR 3.6, P=0.014) and those willing to quit smoking (OR 5.1, P=0.043) were likely to perceive a mobile phone smoking cessation intervention as useful. A smartphone application was preferred over text messages, media messages or interactive voice response technology. Content consisting of motivational messages highlighting the methods and benefits of quitting smoking were requested. Conclusion: People who smoke in Indonesia perceived receiving a potential smoking cessation intervention via mobile phones as useful. A multi-component, personalized smartphone application was the desired intervention technique. Such an intervention developed and implemented within a public health program could help address the tobacco epidemic in Indonesia.

The Use of an Online Learning and Consent Platform in Infertility Treatment

The Use of an Online Learning and Consent Platform in Infertility Treatment

The effect of sukshma vyayama joint loosening yoga on aromatase inhibitor-induced arthralgia (AI) in breast cancer patients: A feasibility study conducted on Facebook.

e23129 Background: AI therapy causes joint pain in up to half of women, and up to 20% become non-compliant with treatment due to pain and discomfort. This pilot study investigated the efficacy of sukshma vyayama in improving AI-induced joint pain and evaluated the feasibility of delivering the intervention on Facebook. Methods: Breast cancer patients undergoing treatment with AI's with self-reported arthralgia were recruited via an IRB-approved announcement posted in two closed breast cancer support groups on Facebook to participate in a yoga study delivered on Facebook. Participants completed BPI, DASH, PRAI and WOMAC questionnaires before and after the study. Intervention consisted of 12 joint loosening exercises performed in a chair, once daily for 12 minutes, Monday-Friday for 4 weeks. Asynchronous video demonstrations were available in a secret Facebook group and viewing confirmed by typing "done" (time-stamped) in comments. Results: 200 women responded. 38 met the inclusion criteria/consent, 26 completed the online consent, interventions and pre/post questionnaires. Paired simple t tests results showed significant (P &lt; 0.05) improvement in all the pain measures and quality of life parameters after yoga intervention compared to baseline. Conclusions: This study provides the first evidence that it is feasible to teach sukshma vyayama to patients on Facebook and that the intervention significantly improves AI-induced arthralgia. Teaching yoga via social media may provide better access to this therapeutic modality to patients at all points in the cancer care continuum globally. [Table: see text]

Attachment styles, self-compassion, and psychological adjustment in long-term breast cancer survivors.

The increasing numbers of breast cancer survivors highlight the importance of delineating factors that identify women who are at risk of poor psychological adjustment in the long term. In breast cancer survivors, higher attachment anxiety and attachment avoidance have been associated with poorer psychological adjustment. Moreover, there is evidence that self-compassion, a kind manner of treating oneself during difficulties, is associated with psychological adjustment in this population. This study aimed to extend the association between attachment styles and psychological adjustment to the context of long-term breast cancer survivors and to determine whether lower self-compassion underlies this association. Participants (N=82) were recruited through emailed invitations to members of the Review and Survey Group of Breast Cancer Network Australia. Following online consent, participants completed measures assessing attachment styles, self-compassion, psychological stress, and the perceived negative impact of cancer. Bootstrapping analyses using the PROCESS macro were used to test the significance of indirect effects. As hypothesised, correlational analyses revealed that higher attachment anxiety and attachment avoidance were significantly and positively associated with stress and perceived negative impact of cancer. Bootstrapping analyses revealed significant indirect effects of attachment anxiety and attachment avoidance (on both stress and perceived negative impact of cancer) through lower self-compassion. These findings suggest that self-compassion training may be useful for enhancing the psychological adjustment of long-term breast cancer survivors. Future longitudinal and experimental studies in more diverse samples are needed to confirm causal directionality of these relationships and to expand upon these findings.

Consumption of Health-Related Content on Social Media Among Adolescent Girls: Mixed-Methods Pilot Study.

BackgroundConsumption of health- and fitness-related social media content is a predominant behavior among teenage girls, which puts them at risk for consuming unreliable health-related information.ObjectiveThis mixed-methods study (qualitative and quantitative) assessed health behavior attitudes and practices as well as social media use among adolescent girls. Additionally, similar practices and behaviors of adults who regularly interact with this population were studied.MethodsGirls aged 12-18 years were recruited to complete a 28-item survey and participate in a 45- to 60-minute focus group. Adults who regularly interact with adolescent girls, including parents, teachers, and healthcare professionals, were recruited from the local community and given a link to provide online consent and complete a survey.ResultsA total of 27 adolescent girls participated in one of nine focus groups. Participants included 18 high school (age: mean 16.1 years; SD 1.3 years) and 9 middle school (age: mean 12.4 years; SD 0.7 years) girls. Eleven adults completed the online survey. Adolescents used social media to communicate and connect with friends, rather than as a source of health information. Although adolescents may see health-related content, most do not follow health-related pages or share such pages themselves, and fewer are actively searching for this information. Adolescents tend to trust information from familiar sources, and the participants reported that they do not follow official news accounts. Adults considered modeling and discussing healthy behaviors important and reportedly expected adolescents to see some level of health-related, especially fitness-related, content on social media.ConclusionsEducation interventions are warranted for both adolescents and adults with whom adolescent girls regularly interact, in the areas of sedentary behavior to guide them to access reliable online health-related information and be judicious consumers of online health information.

Perspectives of New Zealand patients and GPs at the beginning of patient portal implementation

ABSTRACT INTRODUCTIONNew Zealand health policy encourages patient access to their electronic medical records via portals. AIMTo discover patient and general practitioner (GP) perspectives of access to electronic medical records and e-messaging in the early portal implementation phase. METHODSIn 2014, Auckland primary health organisations and an Accident &amp;amp; Medical organisation were asked to invite their GPs to complete an online survey and consent for a researcher to attend their waiting room and invite patients to complete a survey. RESULTSIn total, 421 patients (13% Māori, 18% Pacific, 7% Asian, 53% NZ European/Other) participated from 13 general practices. Most (77%) knew they were entitled to see their medical records and 90% were interested in viewing them. Over two-thirds thought that viewing their records online and e-messaging their practice was a good idea. Over 80% disagreed that they would be worried, confused or embarrassed by seeing their records, with 59% expecting portals to facilitate understanding of their medical conditions. Internet security and privacy concerned 40% of patients. Among 83 GPs who completed the survey, six (7%) had already implemented portals. Few were comfortable to open up the whole health record, especially visit notes. While GPs thought that portal access may help patients better understand their plan of care, their main concerns related to causing confusion and worry. Portal implementation was expected to change GP documentation and increase practice workload and costs without demonstrable benefit to practices. DISCUSSIONAt the beginning of portal adoption, patients were interested. GPs were more reticent, unsure whether the benefits would outweigh the downsides for their patients and practice workload.

Sun Safe Partners: A pilot and feasibility trial of a couple-focused intervention to improve sun protection practices.

This single arm pilot intervention study evaluated the feasibility and preliminary impact of a Sun Safe Partners, which is a couple-focused intervention targeting improved sun protection behavior. Data were collected from New Jersey between August 2015 and March 2016. Participants were 61 couples reporting low levels of sun protection recruited from an online panel. After providing online consent, couples received mailed pamphlets and participated in a call where they discussed current levels of sun protection, made an Action Plan to improve sun protection, and discussed ways of assisting one another in improving sun protection. A call summary was mailed afterwards. Feasibility was assessed by study enrollment, call participation, follow-up survey completion, and intervention evaluation. Participants completed a baseline survey, and a one month and six month post-intervention survey assessing sun protection as well as individual and relationship-centered sun protection attitudes and practices. Results indicated that acceptance into the trial was 22.1%. Call participation was high (84%) and the intervention was well-evaluated. Among the 51 couples who completed the call and a follow-up, the intervention improved sun protection behaviors. Sun protection benefits, photo-aging risk, and relationship-centered attitudes and practices increased. A couple-focused intervention shows promise for improving sun protection. Future studies using a randomized clinical trial as well as strategies to improve study participation are recommended.

Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep

IntroductionInsomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socioeconomic...

Examining Health Behaviors, Health Literacy, and Self-efficacy in College Students With Chronic Conditions

ABSTRACTBackground: Every year, young adults with chronic conditions matriculate into college, which is a unique transitional period in that students may be managing a chronic condition on their own for the first time. Therefore, it is important to examine which factors may contribute to positive health behaviors and risky behaviors in college students with chronic conditions. Purpose: The current study examined associations between health literacy, self-efficacy, and health behaviors in a sample of college students with chronic conditions. Methods: Data were collected from 147 undergraduate students at a Mid-Atlantic U.S. university. Students completed an online consent and questionnaires assessing chronic conditions, health literacy, self-efficacy, and health behaviors (general behavior, wellness maintenance, substance use). Results: Asthma was the most prevalent self-reported chronic condition (26.1%). Higher levels of health literacy and self-efficacy were significantly associated with general health behaviors and wellness maintenance and fewer substance use behaviors. Discussion: These findings highlight health literacy and self-efficacy as potential foci for maintaining healthy behaviors in college students with chronic conditions. Translation to Health Education Practice: College health centers are important facilitators of promoting college student health. Incorporating health literacy and self-efficacy into Health Education interventions could be effective in improving student health.

Abstract 5371: The Metastatic Breast Cancer Project: Partnering with patients to accelerate progress in cancer research

Abstract The Metastatic Breast Cancer Project (MBCproject) is a research study that directly engages patients (pts) through social media and advocacy groups, and empowers them to share samples, clinical data, and experiences. The goal is to create a publicly available database of genomic, molecular, clinical, and patient-reported data to enable research. Working with pts and advocates, a website (MBCproject.org) was developed that allows pts with metastatic breast cancer (MBC) to register. Registered pts are sent an online consent form that asks for permission to obtain and analyze their medical records and samples. Once enrolled, pts are sent a saliva kit and asked to mail back a saliva sample, which is used to extract germline DNA. We contact participants' medical providers and obtain medical records and a portion of their stored tumor biopsies. Pts may be asked to mail in a blood sample, which is used to extract cell free DNA (cfDNA). Whole-exome sequencing (WES) is performed on tumor DNA, germline DNA, and cfNDA; transcriptome sequencing is performed on tumor RNA. Clinically annotated genomic data are used to study specific pt cohorts (including outliers) and to identify mechanisms of response and resistance to therapies. All de-identified data are shared via public databases. Study updates are shared with participants regularly. From 10/2015-11/2017, 4237 MBC pts registered, representing over 1,000 institutions. 95% answered the 16-question survey about their cancer, treatments, and demographic information. 2471 (58%) completed the consent form. 2,136 saliva kits were mailed to pts and 1,523 saliva samples were sent in (71%). 408 blood kits were mailed to pts and 175 blood samples have been received for cfDNA analysis. To date, we have obtained medical records from 311 pts and 190 tumors from 127 pts. In 10/2017, all data generated so far were publicly released on cbioportal.org, including WES for 103 tumors from 78 pts linked to clinical data including pathology (22 elements), medical record abstraction including all treatments and timelines/durations (67 elements), and patient-reported data (11 elements). 81% of biopsies included in this release were from the breast and 19% from metastatic sites. 75% were obtained prior to any therapy, 24% following therapy. New data will be released 4/2018 and every six months thereafter, as they are generated. Additional patient-reported data, including treatments, side effects, quality of life, family history, pregnancies, and sites of metastasis, will also be collected and shared. In summary, a patient-driven approach enabled rapid identification of thousands of MBC pts willing to share samples and clinical data. Remote acquisition of medical records, saliva, blood, and tumor tissue for pts across the U.S. is feasible. This shared clinico-genomic database should enable research in MBC and may serve as a model for patient-driven research in other cancers. Citation Format: Nikhil Wagle, Corrie Painter, Elana Anastasio, Michael Dunphy, Mary McGillicuddy, Rachel Stoddard, Esha Jain, Dewey Kim, Simona Di Lascio, Brett N. Tompson, Sara Balch, Beena Thomas, Priti Kumari, Shawn Johnson, Jamie Holloway, Ofir Cohen, Erik H. Knelson, Katie Larkin, Sam Pollock, Alicia Wong, Samira Bahl, Simone Maiwald, Andrew Zimmer, Esme O. Baker, Jen Hendry Lapan, Scott Sutherland, Scott Sassone, Viktor Adalsteinsson, Eric S. Lander, Todd R. Golub. The Metastatic Breast Cancer Project: Partnering with patients to accelerate progress in cancer research [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 5371.