Pain assessment & management decision-making in pediatric critical care.

PURPOSE: The aim of this study was to explore how nurses in the Pediatric Intensive Care Unit (PICU) reach their pain management decisions in children who are mechanically ventilated and chemically paralyzed. DESIGN AND METHODS: A qualitative descriptive design was used following a quantitative phase of a multi-method study. Eighteen PICU nurses participated in semi-structured interviews aiming at understanding how they assess pain and make management decisions. Content analysis was used to guide coding and generate themes. RESULTS: Three major themes were identified: 1) Assessment or cues that nurses use to trigger a pain assessment; 2) Mental models or patterns that nurses create to interpret cues to guide decision-making; 3) External factors that inhibit or facilitate decision-making. Overall, nurses rely on physiological cues to assess pain. From there, a large amount of variation exists on how nurses interpret those cues to make their pain management decision. External factors such as unit culture, perceived barriers and facilitators, and the nurse's experiences impacted how decisions are made. CONCLUSIONS: Variation exists in the mental models' nurses create to make their pain management decision in this population. Nurses reported confusion on pain and sedation scale selection and various documentation practices for pain assessment. "Assume pain present" was identified as a concept and documentation practice that may guide decisions; further research is needed. PRACTICE IMPLICATIONS: Development of clinician decision support tools that not only aid their understanding of reliable pain cues but also help create clear documentation practices may help nurses make pain management decisions.

Frequency and Prediction of Burnout Among Physicians Who Completed Palliative Care Fellowship Training - A 10 Year Survey.

CONTEXT: Palliative Care (PC) physicians are vulnerable to burnout given the nature of practice. Reports suggest that burnout frequency is variable across different countries. OBJECTIVE: The main objective of our study was to determine knowledge, attitudes and frequency of burnout among Hospice and Palliative Medicine (HPM) Fellowship graduates trained at a comprehensive cancer center. METHODS: We conducted a survey to determine the knowledge, attitudes, and frequency of burnout in former fellows, consisting of the Maslach Burnout Inventory (MBI) and 41 custom questions. Palliative care fellows who trained at a Comprehensive Cancer Center from 2008 to 2018 were included in the survey. RESULTS: Eighty-four percent of the 52 eligible physicians completed surveys. Median age was 38 years, with 68% females. Seventy-seven percent practiced PC more than 50% of time. Median practice duration was four years, and 84% were board certified. Most common disease types treated were cancer (89%), cardiac (43%) and pulmonary (43%). Burnout rate was high at 52% (n=20). The median scores for emotional exhaustion were 25.5, depersonalization 9, and personal accomplishment 48. Female gender (P=0.07) and having administration as a component in the job description (P=0.044) were associated with risk of burnout. Clinical care setting, work hours/week, frequency of weekend calls, and size of team were not significantly associated with burnout. CONCLUSION: Burnout among former fellows trained in HPM between 2008 and 2018 is high. More research is needed to develop strategies to better prevent and manage burnout among HPM fellowship trained PC physicians.

Economic Evaluation of Universal Lynch Syndrome Screening Protocols among Newly Diagnosed Patients with Colorectal Cancer.

We conducted an updated economic evaluation, from a healthcare system perspective, to compare the relative effectiveness and efficiency of eight Lynch syndrome (LS) screening protocols among newly diagnosed colorectal cancer (CRC) patients. We developed decision analytic models for a hypothetical cohort of 1000 patients. Model assumptions and parameter values were based on literature and expert opinion. All costs were in 2018 USD. For identifying LS cases, the direct germline sequencing (DGS) protocol provided the best performance (sensitivity 99.90%, 99.57-99.93%; specificity 99.50%, 97.28-99.85%), followed by the tumor sequencing to germline sequencing (TSGS) protocol (sensitivity, 99.42%, 96.55-99.63%; specificity, 96.58%, 96.46-96.60%). The immunohistochemistry (IHC) protocol was most efficient at $20,082 per LS case identified, compared to microsatellite instability (MSI) ($22,988), DGS ($31,365), and TSGS ($104,394) protocols. Adding double-somatic testing to IHC and MSI protocols did not change sensitivity and specificity, increased costs by 6% and 3.5%, respectively, but reduced unexplained cases by 70% and 50%, respectively. DGS would be as efficient as the IHC protocol when the cost of germline sequencing declines under $368 indicating DGS could be an efficient option in the near future. Until then, IHC and MSI protocols with double-somatic testing would be the optimal choices.

Development of the Tiers of Service framework to support system and operational planning for children's healthcare services.

BACKGROUND: Providing access to pediatric healthcare services in British Columbia, Canada, presents unique challenges given low population densities spread across large geographic distances combined with a lack of availability of specialist providers in remote areas, leading to quality of care shortcomings and inequalities in care delivery. The study objective was to develop a framework that provides a common language and methodology for defining and planning child and youth healthcare services across the province. METHODS: The framework was developed in two phases. In Phase 1, a literature and jurisdictional review was completed using the following inclusion criteria: (i) description of a framework focusing on organizing service delivery systems (ii) that supports health service planning, (iii) includes specialty or subspecialty services and (iv) has been published since 2008. In Phase 2, a series of meetings with key provincial stakeholders were held to receive feedback on the developed Tiers of Service framework versions that were based on the literature and jurisdictional review and adjusted to the British Columbian health care context. The final version was endorsed by the Child Health BC Steering Committee. RESULTS: Ten medical articles and thirteen jurisdictional papers met the established selection criteria and were included in this study. Most frameworks were developed by the Australian national or state jurisdictions and published in jurisdictional papers (n = 8). Frameworks identified in the medical literature were mainly developed in Canada (n = 3) and the US (n = 3) and focused on maternity, neonatal, critical care and oncology services. Based on feedback received from the expert group, the framework was expanded to include community-based services, prevention and health determinants. The final version of the Tiers of Service framework describes the specific services to be delivered at each tier, which are categorized as Tier 1 (community services) through Tier 6 (sub-specialized services). Two consecutive steps were identified to effectively use the framework for operational and system planning: (i) development of a 'module' outlining the responsibilities and requirements to be delivered at each tier; and (ii) assessment of services provided at the health care facility against those described in the module, alignment to a specific tier, identification of gaps at the local, regional and provincial level, and implementation of quality improvement initiatives to effectively address the gaps. CONCLUSIONS: The benefits of the Tiers of Service framework and accompanying modules for health service planning are being increasingly recognized. Planning and coordinating pediatric health services across the province will help to optimize flow and improve access to high-quality services for children living in British Columbia.

Edmonton Symptom Assessment Scale Time Duration of Self-Completion Versus Assisted Completion in Patients with Advanced Cancer: A Randomized Comparison.

INTRODUCTION: To compare the time duration of self-completion (SC) of the Edmonton Symptom Assessment Scale (ESAS) by patients with advanced cancer (ACPs) versus assisted completion (AC) with a health care professional. MATERIALS AND METHODS: In this randomized comparison of ACPs seen in initial consultation at the outpatient Supportive Care Center at MD Anderson, ACPs who have never completed the ESAS at MD Anderson were allocated (1:1) to either SC of the ESAS form versus AC by a nurse. Time of completion was measured by the nurse using a stopwatch. Patients completed the Rapid Estimate of Adult Literacy in Medicine (REALM) test prior to administration of the ESAS. In the SC group, the nurse reviewed the responses to verify that the reported ESAS scores were correct. RESULTS: A total of 126 ACPs were enrolled (69 patients to AC and 57 to SC). Seventy-one patients were female, median age was 60 years, and median REALM score was 65. Median (interquartile range) time (in seconds) of SC was significantly less than AC (73 [42.9-89.1] vs. 109 [79.5-136.7], p < .0001). With nurse review time included, median time of SC increased to 117 seconds, which was not significantly different from AC (p = .28). Lower literacy (REALM) score and shortness of breath were significantly associated with increased completion time (p = .007). CONCLUSION: Regular use of ESAS will have minimal impact on clinical time, as it can be completed in about 1 minute and provides a concise yet comprehensive and multidimensional perspective of symptoms that affect quality of life of patients with cancer. IMPLICATIONS FOR PRACTICE: Because the Edmonton Symptom Assessment Scale can be completed in less than 2 minutes, hopefully the routine use of this simple yet comprehensive and multidimensional symptom assessment tool will be used at all medical visits in all patients with cancer so that the timely management of symptoms affecting patients' lives and treatment courses can occur, further enhancing personalized cancer care.

Positive impact of genetic counseling assistants on genetic counseling efficiency, patient volume, and cost in a cancer genetics clinic.

PURPOSE: Cancer genetics clinics have seen increasing demand, challenging genetic counselors (GCs) to increase efficiency and prompting some clinics to implement genetic counseling assistants (GCAs). To evaluate the impact of GCAs on Geisinger's cancer genetics clinic, we tracked GC time utilization, new patient volume, and clinic cost per patient before and after implementing a GCA program. METHODS: GCs used time-tracking software while completing preappointment activities. Electronic health records were reviewed for appointment length and number of patients per week. Internal salary data for GCs and GCAs were used to calculate clinic costs per patient. RESULTS: Time spent by GCs completing each preappointment activity (21.8 vs. 15.1 minutes) and appointment length (51.6 vs. 44.5 minutes) significantly decreased after GCA program implementation (p values < 0.001). New patients per week per GC significantly increased (7.9 vs. 11.4, p < 0.001). Weekly clinic cost per patient significantly decreased ($233 vs. $176, p = 0.03). CONCLUSION: Implementing a GCA program increased GC efficiency in preappointment activities and clinic appointments, increased patient volume, and decreased clinic cost per patient. Such a program can improve access to GC services and assist GCs in focusing on the direct patient care for which they are specially trained.

THE DEPRESSION INVENTORY DEVELOPMENT SCALE: Assessment of Psychometric Properties Using Classical and Modern Measurement Theory in a CAN-BIND Trial.

Objective: The goal of the Depression Inventory Development (DID) project is to develop a comprehensive and psychometrically sound rating scale for major depressive disorder (MDD) that reflects current diagnostic criteria and conceptualizations of depression. We report here the evaluation of the current DID item bank using Classical Test Theory (CTT), Item Response Theory (IRT) and Rasch Measurement Theory (RMT). Methods: The present study was part of a larger multisite, open-label study conducted by the Canadian Biomarker Integration Network in Depression (ClinicalTrials.gov: NCT01655706). Trained raters administered the 32 DID items at each of two visits (MDD: baseline, n=211 and Week 8, n=177; healthy participants: baseline, n=112 and Week 8, n=104). The DID's "grid" structure operationalizes intensity and frequency of each item, with clear symptom definitions and a structured interview guide, with the current iteration assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain, and appetite. Participants were also administered the Montgomery- Åsberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) that allowed DID items to be evaluated against existing "benchmark" items. CTT was used to assess data quality/reliability (i.e., missing data, skewness, scoring frequency, internal consistency), IRT to assess individual item performance by modelling an item's ability to discriminate levels of depressive severity (as assessed by the MADRS), and RMT to assess how the items perform together as a scale to capture a range of depressive severity (item targeting). These analyses together provided empirical evidence to base decisions on which DID items to remove, modify, or advance. Results: Of the 32 DID items evaluated, eight items were identified by CTT as problematic, displaying low variability in the range of responses, floor effects, and/or skewness; and four items were identified by IRT to show poor discriminative properties that would limit their clinical utility. Five additional items were deemed to be redundant. The remaining 15 DID items all fit the Rasch model, with person and item difficulty estimates indicating satisfactory item targeting, with lower precision in participants with mild levels of depression. These 15 DID items also showed good internal consistency (alpha=0.95 and inter-item correlations ranging from r=0.49 to r=0.84) and all items were sensitive to change following antidepressant treatment (baseline vs. Week 8). RMT revealed problematic item targeting for the MADRS and QIDSSR, including an absence of MADRS items targeting participants with mild/moderate depression and an absence of QIDS-SR items targeting participants with mild or severe depression. Conclusion: The present study applied CTT, IRT, and RMT to assess the measurement properties of the DID items and identify those that should be advanced, modified, or removed. Of the 32 items evaluated, 15 items showed good measurement properties. These items (along with previously evaluated items) will provide the basis for validation of a penultimate DID scale assessing anhedonia, cognitive slowing, concentration, executive function, recent memory, drive, emotional fatigue, guilt, self-esteem, hopelessness, tension, rumination, irritability, reduced appetite, insomnia, sadness, worry, suicidality, and depressed mood. The strategies adopted by the DID process provide a framework for rating scale development and validation.

Advocacy and actions to address disparities in access to genomic health care: A report on a National Academies workshop.

BACKGROUND: In the United States, access to genomic risk assessment, testing, and follow up care is most easily obtained by those who have sufficient financial, educational, and social resources. Multiple barriers limit the ability of populations without those resources to benefit from health care that integrates genomics in assessment of disease risk, diagnosis, and targeted treatment. PURPOSE: To summarize barriers and potential actions to reduce genomic health care disparities. METHOD: Summarize authors' views on discussions at a workshop hosted by the National Academy of Medicine. DISCUSSION: Barriers include access to health care providers that utilize genomics, genetic literacy of providers and patients, and absence of evidence of gene variants importance in ancestrally diverse underserved populations. CONCLUSION: Engagement between underserved communities, health care providers, and policy makers is an essential component to raise awareness and seek solutions to barriers in access to genomic health care for all populations.

Integration of a Mandatory Palliative Care Education Into Hematology-Oncology Fellowship Training in a Comprehensive Cancer Center: A Survey of Hematology Oncology Fellows.

PURPOSE: The primary aim of this study was to determine the attitudes and beliefs of hematology and medical oncology (HMO) fellows regarding palliative care (PC) after they completed a 4-week mandatory PC rotation. METHODS: The PC rotation included a 4-week standardized curriculum covering all PC domains. HMO fellows were provided educational materials and attended all didactic sessions. All had clinical rotation in an acute PC unit and an outpatient clinic. All HMO fellows from 2004 to 2017 were asked to complete a 32-item survey on oncology trainee perception of PC. RESULTS: Of 105 HMO fellows, 77 (73%) completed the survey. HMO fellows reported that PC rotation improved assessment and management of symptoms (98%); opioid prescription (89%), opioid rotation (78%), and identification of opioid adverse effects (87%); communication with patients and families (91%), including advance care planning discussion (88%) and do-not-resuscitate discussion (88%); and they reported comfort with discussing ethical issues (74%). Participants reported improvement in knowledge of symptom assessment and management (n = 76; 98%) as compared with efficacy in ethics (n = 57 [74%]; P = .0001) and for coping with stress of terminal illness (n = 45 [58%]; P = .0001). The PC rotation educational experience was considered either far better or better (53%) or the same (45%) as other oncology rotations. Most respondents (98%) would recommend PC rotations to other HMO fellows, and 95% felt rotation should be mandatory. CONCLUSION: HMO fellows reported PC rotation improved their attitudes and knowledge in all PC domains. PC rotation was considered better than other oncology rotations and should be mandatory.

Patients' Perspective of Timeliness and Usefulness of an Outpatient Supportive Care Referral at a Comprehensive Cancer Center.

CONTEXT: Current guidelines recommend early referral to palliative care for patients with advanced cancer; however, no studies have examined the optimal timing of referral from the patients' perspective. OBJECTIVES: To examine patients' perceptions of timeliness of referral and its association with survival among patients with advanced cancer referred to an outpatient supportive care (SC) clinic. METHODS: This cross-sectional prospective study in an SC clinic at a comprehensive cancer center included patients aged 18 years or older with locally advanced, recurrent, or metastatic cancer. Patients were asked to complete an anonymous survey regarding the timeliness and perceived usefulness of SC referral within four weeks of their first SC consultation. RESULTS: Of 253 eligible patients, 209 (83%) enrolled in the study and 200 completed the survey. Median survival was 10.3 months. Most patients (72%) perceived that referral occurred "just in time," whereas 21% felt it was "late," and 7% felt "early." A majority (83%) found the referral useful, and 88% would recommend it to other patients with cancer. The perception of being referred early was associated with lower reported levels of pain (P = 0.043), fatigue (P = 0.004), drowsiness (P = 0.005), appetite loss (P = 0.041), poor well-being (P = 0.041), and lower physical (P = 0.001) and overall symptom distress (P = 0.001). No other associations were found between perceived timeliness and usefulness and patients' baseline characteristics. CONCLUSION: Most patients with a median survival of 10 months perceived that SC referral was timely and useful. Patient care needs rather than the timing of advanced cancer diagnosis drove this perception of referral timing. Lower symptom burden was associated with the perception of being referred to early.

Patterns of Opioid Prescription, Use, and Costs Among Patients With Advanced Cancer and Inpatient Palliative Care Between 2008 and 2014.

PURPOSE: An understanding of opioid prescription and cost patterns is important to optimize pain management for patients with advanced cancer. This study aimed to determine opioid prescription and cost patterns and to identify opioid prescription predictors in patients with advanced cancer who received inpatient palliative care (IPC). MATERIALS AND METHODS: We reviewed data from 807 consecutive patients with cancer who received IPC in each October from 2008 through 2014. Patient characteristics; opioid types; morphine equivalent daily dose (MEDD) in milligrams per day of scheduled opioids before, during, and after hospitalization; and in-admission opioid cost per patient were assessed. We determined symptom changes between baseline and follow-up palliative care visits and the in-admission opioid prescription predictors. RESULTS: A total of 714 (88%) of the 807 patients were evaluable. The median MEDD per patient decreased from 150 mg/d in 2008 to 83 mg/d in 2014 ( P < .001). The median opioid cost per patient decreased and then increased from $22.97 to $40.35 over the 7 years ( P = .03). The median MEDDs increased from IPC to discharge by 67% ( P < .001). The median Edmonton Symptom Assessment Scale pain improvement at follow-up was 1 ( P < .001). Younger patients with advanced cancer (odds ratio [OR[, 0.95; P < . 001) were prescribed higher preadmission MEDDs (OR, 1.01; P < .001) more often in the earlier study years (2014 v 2009: OR, 0.18 [ P = .004] v 0.30 [ P = .02]) and tended to use high MEDDs (> 75 mg/d) during hospitalization. CONCLUSION: The MEDD per person decreased from 2008 to 2014. The opioid cost per patient decreased from 2008 to 2011 and then increased from 2012 to 2014. Age, prescription year, and preadmission opioid doses were significantly associated with opioid doses prescribed to patients with advanced cancer who received IPC.

Enrichment sampling for a multi-site patient survey using electronic health records and census data.

Objective: We describe a stratified sampling design that combines electronic health records (EHRs) and United States Census (USC) data to construct the sampling frame and an algorithm to enrich the sample with individuals belonging to rarer strata. Materials and Methods: This design was developed for a multi-site survey that sought to examine patient concerns about and barriers to participating in research studies, especially among under-studied populations (eg, minorities, low educational attainment). We defined sampling strata by cross-tabulating several socio-demographic variables obtained from EHR and augmented with census-block-level USC data. We oversampled rarer and historically underrepresented subpopulations. Results: The sampling strategy, which included USC-supplemented EHR data, led to a far more diverse sample than would have been expected under random sampling (eg, 3-, 8-, 7-, and 12-fold increase in African Americans, Asians, Hispanics and those with less than a high school degree, respectively). We observed that our EHR data tended to misclassify minority races more often than majority races, and that non-majority races, Latino ethnicity, younger adult age, lower education, and urban/suburban living were each associated with lower response rates to the mailed surveys. Discussion: We observed substantial enrichment from rarer subpopulations. The magnitude of the enrichment depends on the accuracy of the variables that define the sampling strata and the overall response rate. Conclusion: EHR and USC data may be used to define sampling strata that in turn may be used to enrich the final study sample. This design may be of particular interest for studies of rarer and understudied populations.

Group Yoga Effects on Cancer Patient and Caregiver Symptom Distress: Assessment of Self-reported Symptoms at a Comprehensive Cancer Center.

BACKGROUND: Complementary and integrative health approaches such as yoga provide support for psychosocial health. We explored the effects of group-based yoga classes offered through an integrative medicine center at a comprehensive cancer center. METHODS: Patients and caregivers had access to two yoga group classes: a lower intensity (YLow) or higher intensity (YHigh) class. Participants completed the Edmonton Symptom Assessment System (ESAS; scale 0-10, 10 most severe) immediately before and after the class. ESAS subscales analyzed included global (GDS; score 0-90), physical (PHS; 0-60), and psychological distress (PSS; 0-20). Data were analyzed examining pre-yoga and post-yoga symptom scores using paired t-tests and between types of classes using ANOVAs. RESULTS: From July 18, 2016, to August 8, 2017, 282 unique participants (205 patients, 77 caregivers; 85% female; ages 20-79 years) attended one or more yoga groups (mean 2.3). For all participants, we observed clinically significant reduction/improvement in GDS, PHS, and PSS scores and in symptoms (ESAS decrease ≥1; means) of anxiety, fatigue, well-being, depression, appetite, drowsiness, and sleep. Clinically significant improvement for both patients and caregivers was observed for anxiety, depression, fatigue, well-being, and all ESAS subscales. Comparing yoga groups, YLow contributed to greater improvement in sleep versus YHigh (-1.33 vs -0.50, P = .054). Improvement in fatigue for YLow was the greatest mean change (YLow -2.12). CONCLUSION: A single yoga group class resulted in clinically meaningful improvement of multiple self-reported symptoms. Further research is needed to better understand how yoga class content, intensity, and duration can affect outcomes.

Omics research ethics considerations.

BACKGROUND: Pending revisions to the Common Rule include topics consistent with respect for persons, justice, and beneficence for research subjects in studies using omics technologies and are relevant to omics research. PURPOSE: Synthesize trends in bioethics, precision health, and omics nursing science for novice and experienced nursing scholars from which to consider bioethics questions. METHODS: Review topics addressed in the National Institute of Nursing Research (NINR) strategic plan, Common Rule pending revisions, and publications regarding human subjects protection policies. DISCUSSION: Omics research involves decisions regarding understandable informed consent, broad consent, data sharing, trust, equal benefit, equal access, societal variables, privacy, data security, and return of findings to participants. CONCLUSION: Principles of respect for persons, justice, and beneficence as articulated in the Belmont report and reflected in the American Nurses Association (ANA) Code of Ethics provide guidance for human subjects protection procedures to advance omics and nursing science.

Timing of Referral and Characteristics of Uninsured, Medicaid, and Insured Patients Referred to the Outpatient Supportive Care Center at a Comprehensive Cancer Center.

CONTEXT: Low-income patients face barriers to palliative care access, which might negatively influence symptom management and advanced care planning. OBJECTIVE: Our aim was to compare time of referral and characteristics (level of symptom distress) among uninsured (indigent), low-insured (Medicaid), and insured patients presenting to our supportive care center (SCC). METHODS: We conducted a retrospective review of randomly selected 100 indigent, 100 Medicaid, and 300 insured outpatients referred during the same five-year period. We reviewed demographic and clinical characteristics including date of diagnosis of advanced cancer and of first visit to SCC, symptom assessment (Edmonton Symptom Assessment System), type and dose of opioid medication, number of total outpatient visits, and date of last contact with palliative care team. RESULTS: Among 482 evaluable patients, indigent, Medicaid, and insured patients, respectively, had mean (SD) ages of 48 (11), 50 (12), and 63 (13) years (P < 0.001); Edmonton Symptom Assessment System pain scores at first visit of 6.7 (2.5), 5.6 (3.2), and 4.9 (3.2) (P < 0.001); nonwhite race in 60%, 49%, and 25% of cases (P < 0.001); unmarried status in 68%, 64%, and 33% of cases (P < 0.001), while 63%, 87%, and 54% of patients (P < 0.001) were on opioids with median number of encounters per month of 0.6, 0.8, and 0.5 (P = 0.001). Median survival (95% CI) from first visit to last contact was 4.6 (2.8-6.2), 5.4 (3.5-7), and 5.6 (4.7-7.3) months (P = 0.036). CONCLUSION: Patients with limited or no insurance had significantly higher pain and were more frequently on opioids, younger, nonwhite, and not married. They required higher number of SCC follow-up visits. Insurance status did not affect timing of SCC referral or follow-ups at our cancer center.

Self-reported race and ethnicity of US biobank participants compared to the US Census.

Precision medicine envisions a future of effective diagnosis, treatment, and prevention grounded in precise understandings of the genetic and environmental determinants of disease. Given that the original genome-wide association studies represented a predominately European White population, and that diversity in genomic studies must account for genetic variation both within and across racial categories, new research studies are at a heightened risk for inadequate representation. Currently biological samples are being made available for sequencing in biobanks across the USA, but the diversity of those samples is unknown. The aims of this study were to describe the types of recruitment and enrollment materials used by US biobanks and the diversity of the samples contained within their collection. Biobank websites and brochures were evaluated for reading level, health literacy, and factors known to encourage the recruitment of minorities, such as showing pictures of diverse populations. Biobank managers were surveyed by mail on the methods and materials used for enrollment, recruitment, consent, and the self-reported race/ethnicity of biobank participants. From 51 US biobanks (68% response rate), recruitment and enrollment materials were in English only, and most of the websites and brochures exceeded a fifth-grade reading level. When compared to the 2015 US Census, self-reported race/ethnicity of participants was not significantly different for Whites (61%) and blacks (13%). The percentages were significantly lower for Hispanics and Latinos (18 vs. 7%, p = 0.00) and Hawaiian/Pacific Islanders (0.2 vs. 0.01%; p = 0.01) and higher for Asians (13 vs. 5%, p = 0.01). Materials for recruitment predominantly in English may limit participation by underrepresented populations.

Fetal Alcohol Research Caring for Patients with Prenatal Alcohol Exposure: A Needs Assessment.

BACKGROUND: Prenatal alcohol exposure (PAE) is the United States' most common preventable cause of birth defects and intellectual and developmental disabilities collectively referred to as Fetal Alcohol Spectrum Disorders (FASD). OBJECTIVES: This study was designed to identify gaps in pediatric providers' knowledge and practices regarding FASD patient identification, diagnosis, management and referral, and to inform needs-based FASD resource development. METHODS: Pediatric providers (pediatricians, trainees, nurse practitioners) were exposed to survey links embedded in newsletters electronically distributed to the membership of two national professional societies. Survey responses were compiled and analyzed using descriptive statistics. RESULTS: Of the 436 respondents, 71% were pediatricians and 88.2% suspected that a child in their practice could have an FASD. Only 29.2% of respondents felt "very comfortable" diagnosing or referring an individual with suspected FASD. Merely 11.5% were satisfied with their current FASD knowledge base and practice behaviour. Most respondents (89.6%) indicated online continuing education courses as preferred learning method and suggested their knowledge and practices would be best enhanced through FASD-specific diagnostic and referral checklists or algorithms, and patient education brochures and fact sheets. CONCLUSIONS: This study showed that few respondents were satisfied with their current FASD knowledge or practice behaviours. Continuing FASD education, particularly through online courses, was strongly desired. To maximize FASD recognition and optimize care for patients with FASDs, pediatric care providers must ensure that their FASD knowledge base, practice skills and provision of medical home care remain current.

Public Attitudes toward Consent and Data Sharing in Biobank Research: A Large Multi-site Experimental Survey in the US.

Individuals participating in biobanks and other large research projects are increasingly asked to provide broad consent for open-ended research use and widespread sharing of their biosamples and data. We assessed willingness to participate in a biobank using different consent and data sharing models, hypothesizing that willingness would be higher under more restrictive scenarios. Perceived benefits, concerns, and information needs were also assessed. In this experimental survey, individuals from 11 US healthcare systems in the Electronic Medical Records and Genomics (eMERGE) Network were randomly allocated to one of three hypothetical scenarios: tiered consent and controlled data sharing; broad consent and controlled data sharing; or broad consent and open data sharing. Of 82,328 eligible individuals, exactly 13,000 (15.8%) completed the survey. Overall, 66% (95% CI: 63%-69%) of population-weighted respondents stated they would be willing to participate in a biobank; willingness and attitudes did not differ between respondents in the three scenarios. Willingness to participate was associated with self-identified white race, higher educational attainment, lower religiosity, perceiving more research benefits, fewer concerns, and fewer information needs. Most (86%, CI: 84%-87%) participants would want to know what would happen if a researcher misused their health information; fewer (51%, CI: 47%-55%) would worry about their privacy. The concern that the use of broad consent and open data sharing could adversely affect participant recruitment is not supported by these findings. Addressing potential participants' concerns and information needs and building trust and relationships with communities may increase acceptance of broad consent and wide data sharing in biobank research.

Patient-reported sleep disturbance in advanced cancer: frequency, predictors and screening performance of the Edmonton Symptom Assessment System sleep item.

AIMS: Sleep Disturbance (SD) is a severe debilitating symptom in advanced cancer patients (ACP). However, routine screening of SD is uncommon. The primary aim of this study was to determine the optimal cutoff score for SD screening for Edmonton Symptom Assessment system (ESAS) sleep item using Pittsburgh Sleep Quality Index (PSQI) as a gold standard. We also determined the frequency of SD, obstructive sleep apnea symptoms (OSA) and restless leg syndrome (RLS) and factors associated with SD. METHODS: We prospectively surveyed 180 consecutive ACP. Patients completed validated assessment for symptoms. We determined epidemiological performance, receiver operating characteristics, and correlations of SD. RESULTS: SD according to PSQI was diagnosed in 112/180 (62%), and median (IQR) ESAS sleep was 5 (2-7). ESAS sleep ≥ 4 had a sensitivity of 74% and 80%, and specificity of 71% and 64% in the training and validation samples, respectively for screening of SD. The frequency of OSA was 61%; RLS was 38%. ESAS sleep was associated [r, p-value] with PSQI (0.61, <0.0001), pain (0.4, <0.0001); fatigue (0.35, <0.0001); depression (0.20, 0.006); anxiety (0.385, <0.0001); drowsiness (0.385, <0.0001), shortness of breath (0.24, <0.0014); anorexia (0.32, <0.0001), well-being (0.36, <0.0001). Multivariate analysis found well-being (OR per point 1.34, p=0.0003), pain (OR 1.21, p<0.0037), dyspnea (OR 1.16, p=0.027), and OSA (OR 0.31, P=0.003) as independent predictors of SD. There was no association between SD and survival. CONCLUSIONS: SD is frequent and ESAS SD item ≥ 4 has good sensitivity for SD screening.

The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder.

The Depression Inventory Development project is an initiative of the International Society for CNS Drug Development whose goal is to develop a comprehensive and psychometrically sound measurement tool to be utilized as a primary endpoint in clinical trials for major depressive disorder. Using an iterative process between field testing and psychometric analysis and drawing upon expertise of international researchers in depression, the Depression Inventory Development team has established an empirically driven and collaborative protocol for the creation of items to assess symptoms in major depressive disorder. Depression-relevant symptom clusters were identified based on expert clinical and patient input. In addition, as an aid for symptom identification and item construction, the psychometric properties of existing clinical scales (assessing depression and related indications) were evaluated using blinded datasets from pharmaceutical antidepressant drug trials. A series of field tests in patients with major depressive disorder provided the team with data to inform the iterative process of scale development. We report here an overview of the Depression Inventory Development initiative, including results of the third iteration of items assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain and appetite. The strategies adopted from the Depression Inventory Development program, as an empirically driven and collaborative process for scale development, have provided the foundation to develop and validate measurement tools in other therapeutic areas as well.