Hybrid-delivered cognitive behavioral symptom management and activity coaching intervention for patients undergoing hematopoietic stem cell transplant: Findings from intervention development and a pilot randomized trial.

OBJECTIVE: Develop and pilot test a mobile health (mHealth) cognitive behavioral coping skills training and activity coaching protocol (HCT Symptoms and Steps) for hematopoietic stem cell transplant (HCT) patients. DESIGN: Two-phase, mixed methods study. SAMPLE: HCT patients and healthcare providers. METHODS: Phase I was patient (n = 5) and provider (n = 1) focus groups and user testing (N = 5) to develop the HCT Symptoms and Steps protocol. Phase II was a pilot randomized trial (N = 40) to evaluate feasibility, acceptability, and pre-to-post outcomes (e.g., physical disability, pain, fatigue, distress, physical activity, symptom self-efficacy) compared to an education control. FINDINGS: Qualitative feedback on symptoms, recruitment strategies, coping skills, and mHealth components (e.g., Fitbit, mobile app) were integrated into the protocol. HCT Symptoms and Steps were feasible and acceptable. Pre-post changes suggest physical disability and activity improved while symptoms (e.g., fatigue, distress) decreased. CONCLUSIONS: HCT Symptoms and Steps have strong feasibility and acceptability and shows promise for benefits. Larger, fully-powered randomized trials are needed to examine intervention efficacy. IMPLICATIONS: HCT Symptoms and Steps may reduce physical disability and improve health outcomes post-transplant. CLINICAL TRIAL REGISTRATION NUMBER: NCT03859765.

Does Cancer Treatment-Related Financial Distress Worsen Over Time?

BACKGROUND Patients with cancer are at risk for both objective and subjective financial distress. Financial distress during treatment is adversely associated with physical and mental well-being. Little is known about whether patients' subjective financial distress changes during the course of their treatment.method This is a cross-sectional study of insured adults with solid tumors on anti-cancer therapy for ≥1 month, surveyed at a referral center and three rural oncology clinics. The goal was to investigate how financial distress varies depending on where patients are in the course of cancer therapy. Financial distress (FD) was assessed via a validated measure; out-of-pocket (OOP) costs were estimated and medical records were reviewed for disease/treatment data. Logistic regression was used to evaluate the potential association between treatment length and financial distress.RESULTS Among 300 participants (86% response rate), median age was 60 years (range 27-91), 52.3% were male, 78.3% had stage IV cancer or metastatic recurrence, 36.7% were retired, and 56% had private insurance. Median income was $60,000/year and median OOP costs including insurance premiums were $592/month. Median FD score (7.4/10, SD 2.5) corresponded to low FD with 16.3% reporting high/overwhelming distress. Treatment duration was not associated with the odds of experiencing high/overwhelming FD in single-predictor (OR = 1.01, CI [.93, 1.09], P = .86) or multiple predictor regression models (OR = .98, CI [.86, 1.12], P = .79). Treatment duration was not correlated with FD as a continuous variable (P = .92).LIMITATIONS This study is limited by its cross-sectional design and generalizability to patients with early-stage cancer and those being treated outside of a major referral center.CONCLUSION Severity of cancer treatment-related financial distress did not correlate with time on treatment, indicating that patients are at risk for FD throughout the treatment continuum. Screening for and addressing financial distress should occur throughout the course of cancer therapy.

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery.

OBJECTIVE: Behavioral cancer pain interventions are efficacious for improving important pain outcomes; yet, traditional in-person delivery limits patient access. This study compared videoconference-delivered mobile health pain coping skills training (mPCST) to in-person pain coping skills training (PCST-traditional). METHODS: This study was a randomized, noninferiority trial with cancer patients. Participants (N = 178) were randomly assigned to four, 45-minute sessions of mPCST or PCST-traditional. Session content focused on evidence-based cognitive and behavioral pain management skills. Assessments were completed at baseline, posttreatment, and 3-month posttreatment, and included measures of primary intervention outcomes (ie, pain severity and pain interference) and secondary intervention outcomes (ie, physical symptoms, psychological distress, physical well-being, and self-efficacy). The main study aim tested whether mPCST was more accessible (defined as feasibility, acceptability, patient burden, and engagement) than PCST-traditional. The second aim tested whether mPCST was noninferior to PCST-traditional. RESULTS: mPCST demonstrated significantly greater feasibility (ie, attrition, adherence, and time to completion) than PCST-traditional. Both groups reported similar patient burden and engagement as well as a high degree of acceptability. All intervention outcomes demonstrated noninferiority at posttreatment and, with the exception of physical symptoms, 3-month posttreatment. Concerning the primary intervention outcomes, 95% CIs for the mean differences (d) were below the noninferiority margin of 1 for pain severity (posttreatment d = 0.09, 95% CI, -0.63-0.81; 3 months d = -0.43 95% CI, -1.22-0.36) and pain interference (posttreatment d = -0.11, 95% CI, -0.99-0.76; 3 months d = -0.26 95% CI, -1.14-0.62). CONCLUSION: mPCST is highly accessible and noninferior to PCST-traditional.

Patient-reported distress in Hodgkin lymphoma across the survivorship continuum.

PURPOSE: Hodgkin lymphoma (HL) survivors face long-term, elevated risk of treatment-related sequelae, including psychosocial distress associated with poor health outcomes. The magnitude and sources of distress are not well described in the routine care of HL outside of clinical trials. METHODS: We conducted a retrospective cohort study of patients visiting a tertiary-care center for treatment or long-term follow-up of HL. Patient-reported distress was documented using the National Comprehensive Cancer Network Distress Thermometer (DT) and Problem List. Three survivor groups were compared using descriptive methods: on treatment, surviving < 5 years, and surviving ≥ 5 years since diagnosis. RESULTS: A total of 1524 DT were abstracted for 304 patients (106 on treatment, 77 surviving < 5 years, and 121 surviving ≥ 5 years). Distress was low overall (median DT = 1, inter-quartile range 0-4) and was similar across survivor groups. However, actionable distress (score ≥ 4) was reported at 29.5% of clinical encounters. Patients on treatment more frequently reported actionable distress (32.5% of visits) compared with patients surviving < 5 years (20.4%) and ≥ 5 years (28.7%) (P = 0.065). Distress was associated primarily with physical and emotional problems, especially fatigue, worry, and sleep. We did not observe any associations between distress and clinical prognostic factors. CONCLUSIONS: Distress burden is low in HL, but survivorship is marked by periods of actionable distress, largely related to physical symptoms and emotional issues. This burden may be higher when on treatment and is unrelated to disease-related prognostic factors. Survivorship research typically focuses on the post-therapy period, but our results support testing the efficacy of interventions to address distress in HL during active treatment as well.

Patient-Reported Distress in Myelodysplastic Syndromes and Its Association With Clinical Outcomes: A Retrospective Cohort Study.

Background: NCCN defines distress as a multifactorial, unpleasant emotional experience of a psychological nature that may interfere with patients' ability to cope with cancer symptoms and treatment. Patients with myelodysplastic syndromes (MDS) are at risk for distress due to the largely incurable nature of this hematopoietic malignancy and its symptom burden, yet associations with clinical outcomes are unknown. Methods: We retrospectively reviewed patient-reported distress data from adult ambulatory patients with MDS visiting a single, tertiary care medical center from July 2013 to September 2015. Demographic, diagnostic, treatment, and comorbidity information were abstracted from records along with NCCN Distress Thermometer (DT) and Problem List (PL) scores. Survival was analyzed using the Kaplan-Meier method and Cox proportional hazards regression. Results: We abstracted 376 DT scores (median, 1; range, 0-10) from 606 visits and 110 patients (median, 2 DT scores/patient; range, 1-16). NCCN Guidelines suggest that patients with DT scores ≥4 should be evaluated for referral to specialty services to address unmet needs. A total of 54 patients (49%) had at least 1 DT score ≥4 and 20 (18%) had 2 or more DT scores ≥4; 98 patients (89.1%) reported 1,379 problems during 23,613 person-days of follow-up (median, 4 problems/patient/visit; range, 1-23). The 5 most frequently reported problems were fatigue (181 times; 78 patients), pain (95 times; 46 patients), worry (80 times; 45 patients), sleep (78 times; 41 patients), and tingling hands/feet (68 times; 33 patients). After adjustment for risk stratification at diagnosis, a single point increase on the DT was associated with an increased risk of death (hazard ratio, 1.18; 95% CI, 1.01-1.36). Conclusions: Patients with MDS experience a high burden of distress, and patient-reported distress is associated with clinical outcomes. Distress should be further studied as a prognostic variable and a marker of unmet needs in MDS.

Design and Rationale of the Metastatic Renal Cell Carcinoma (MaRCC) Registry: A Prospective Academic and Community-Based Study of Patients With Metastatic Renal Cell Cancer.

The Metastatic Renal Cell Cancer Registry, a large, nationally representative, prospective registry of patients with metastatic renal cell carcinoma (mRCC), aims to understand real-world treatment patterns and outcomes of patients with mRCC in routine clinical practice across the United States. This observational study is designed to enroll 500 patients with previously untreated mRCC from approximately 60 academic and community treatment sites; as of December 7, 2016, 500 patients have enrolled at 54 sites. Key endpoints include real-world data on reasons for treatment initiation and discontinuation; treatment regimens; disease progression; patient-reported outcomes; and healthcare resource utilization in this patient population.

Quality of Life is Similar between Long-term Survivors of Indolent and Aggressive Non-Hodgkin Lymphoma.

Differences in quality of life (QOL) of long-term survivors of aggressive or indolent subtypes of non-Hodgkin lymphoma (NHL) have not been frequently evaluated. We assessed these differences by analyzing results of a large QOL survey of long-term NHL survivors. We hypothesized that the incurable nature of indolent NHL would relate to worse QOL in long-term survivors while the potentially cured long-term survivors of aggressive lymphoma would have better QOL. We found that QOL was similar between the two groups. Results suggest that patients with indolent NHL are coping well with their disease, yet experience some overall feelings of life threat.

Validation and real-world assessment of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) scale in patients with advanced non-small cell lung cancer and the cancer anorexia-cachexia syndrome (CACS).

PURPOSE: Patients with cancer anorexia-cachexia syndrome (CACS) suffer a significant symptom burden, impaired quality of life (QoL), and shorter survival. Measurement of QoL impairments related to CACS is thereby important both in clinical practice and in research. We aimed to further validate the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) scale in an advanced lung cancer population. METHODS: We tested the performance of the FAACT and its anorexia-cachexia subscale (ACS) within a dataset of patients with advanced non-small cell lung cancer (aNSCLC), using standard statistical methods. We then compared the performance of commonly used QoL measures stratified by CACS status and by patient self-report of appetite and weight loss. RESULTS: The FAACT and its ACS demonstrate internal validity consistent with acceptable published ranges for other QoL scales (Cronbach alpha = 0.9 and 0.79, respectively). Correlation coefficients demonstrate moderate correlations in the expected directions between FAACT and ACS and scales that measure related constructs. Comparing patients with and without CACS, the ACS is more sensitive to change than other QoL instruments (mean score 33.1 vs. 37.2, p = 0.011, ES = 0.58). CONCLUSION: In patients with aNSCLC, the FAACT and its ACS performed well compared with other instruments, further supporting their validity and value in clinical research. FAACT and ACS scores covaried with symptoms and other QoL changes that are typical hallmarks of CACS, lending further support to their use as QoL endpoints in clinical trials among patients with CACS.

Patient preferences in advanced or recurrent ovarian cancer.

BACKGROUND: The objective of this study was to elucidate relative preferences of women with ovarian cancer for symptoms, treatment-related side effects, and progression-free survival (PFS) relevant to choosing a treatment regimen. METHODS: Women with advanced or recurrent ovarian cancer participated in a survey that included 3 methods to measure patient preferences (ratings, rankings, and a discrete-choice experiment) for 7 attributes: mode of administration, visit frequency, peripheral neuropathy, nausea and vomiting, fatigue, abdominal discomfort, and PFS. Participants were asked to choose between 2 unlabeled treatment scenarios that were characterized using the 7 attributes. Each participant completed 12 choice questions in which attribute levels were assigned according to an experimental design and a fixed-choice question representing 2 chemotherapy regimens for ovarian cancer. RESULTS: In total, 95 women completed the survey. Participants' ratings and rankings revealed greater concern and importance for PFS than for any other attribute (P < .0001 for all). The discrete-choice experiment revealed that the relative odds that a participant would choose a scenario with 18 months, 21 months, and 24 months of PFS versus 15 months of PFS were 1.5 (P = .01), 3.4 (P < .001), and 7.5 (P < .001), respectively. However, participants' choices indicated that they were willing to accept a shorter PFS to avoid severe side effects: 6.7 months to reduce nausea and vomiting from severe to mild, 5.0 months to reduce neuropathy from severe to mild, and 3.7 months to reduce abdominal symptoms from severe to moderate. CONCLUSIONS: PFS is the predominant driver of patient preferences for chemotherapy regimens. However, women in the current study were willing to trade significant PFS time for reductions in treatment-related toxicity.

Is there a relationship between posttraumatic stress and growth after a lymphoma diagnosis?

OBJECTIVE: There are conflicting empirical data regarding the relationship between posttraumatic stress (PTS) and growth (PTG) observed in cancer survivors. Clarification of this association could inform evidence-based therapeutic recommendations to promote adjustment in survivors following a cancer diagnosis. METHODS: This cross-sectional study employed standardized measures to examine the association between PTS and PTG in a sample of long-term lymphoma survivors. In addition, associations between PTG and demographic, clinical and psychosocial variables were identified to inform clinical recommendations. RESULTS: Long-term survivors of non-Hodgkin lymphoma provided informed consent (n = 886; 74% response rate). Subjects averaged 10.2 years post-diagnosis and 62.9 years of age. No significant association was found between the PTS and PTG summary scores. Several demographic and clinical variables (e.g., female gender and greater social support) were independently associated with greater PTG. CONCLUSIONS: Clinicians are advised to be attentive to psychosocial needs throughout the post-cancer diagnosis adjustment period by screening for PTS symptomatology and recognizing that survivors who report growth may also be highly distressed.

Fabrication in a study about honesty: A lost episode of columbo illustrating how forensic statistics is performed.

The three steps of a typical forensic statistical analysis are (1) verify that the raw data file is correct; (2) verify that the statistical analysis file derived from the raw data file is correct; and (3) verify that the statistical analyses are appropriate. We illustrate applying these three steps to a manuscript which was subsequently retracted, focusing on step 1. In the absence of an external source for comparison, criteria for assessing the raw data file were internal consistency and plausibility. A forensic statistical analysis isn't like a murder mystery, and it many circumstances discovery of a mechanism for falsification or fabrication might not be realistic.

Index Symptoms and Prognosis Awareness of Patients With Pancreatic Cancer: A Multi-Site Palliative Care Collaborative.

BACKGROUND: Pancreatic cancer has a poor 5-year survival and carries significant morbidity. Pain is a commonly studied symptom in pancreatic cancer; however, few studies examine the frequency of multiple patient-reported symptoms. Our aim is to ascertain patient-reported symptom burden at initial consultation with a palliative care provider and compare patient prognostic awareness to provider estimation of prognosis. METHODS: Data were extracted from the standardized Quality Data Collection Tool (QDACT). Adults with pancreatic cancer seen by a palliative care provider were included. Descriptive statistics were used to describe demographic features, symptom prevalence and burden, as well as assess patient prognosis awareness defined by congruence or incongruence with provider estimated prognosis. RESULTS: 285 patients were included in our analysis. The average age was 68 years (SD: 12.4), 87.2% were white, 50% male. The mean number of moderate/severe symptoms was 2.6 (SD: 2) out of 9 symptoms. Tiredness (66.7%), appetite (64.5%) and pain (46.2%) had the highest rates of moderate/severe symptom burden. Patients with a prognosis of 1-6 months had the lowest proportion of congruence with provider estimation (56.5%). CONCLUSION: Our study suggests targets to improve patient-centered care of pancreatic cancer. Patients commonly have multiple symptoms that are moderate/severe at time of palliative care referral. While pain has been well-reported, tiredness and decreased appetite are more prevalent at initial visit. This emphasizes the importance of assessing multiple symptoms and working closely with palliative care for early referral. Overall, one third of patient prognosis estimates differed from the provider assessment of prognosis. Our data support the importance of early referral to palliative care to manage symptoms and better prepare patients for end-of-life care.

Needles in a Haystack: Finding Qualitative and Quantitative Collaborators in Academic Medical Centers.

Translational research is a data-driven process that involves transforming scientific laboratory- and clinic-based discoveries into products and activities with real-world impact to improve individual and population health. Successful execution of translational research requires collaboration between clinical and translational science researchers, who have expertise in a wide variety of domains across the field of medicine, and qualitative and quantitative scientists, who have specialized methodologic expertise across diverse methodologic domains. While many institutions are working to build networks of these specialists, a formalized process is needed to help researchers navigate the network to find the best match and to track the navigation process to evaluate an institution's unmet collaborative needs. In 2018, a novel analytic resource navigation process was developed at Duke University to connect potential collaborators, leverage resources, and foster a community of researchers and scientists. This analytic resource navigation process can be readily adopted by other academic medical centers. The process relies on navigators with broad qualitative and quantitative methodologic knowledge, strong communication and leadership skills, and extensive collaborative experience. The essential elements of the analytic resource navigation process are as follows: (1) strong institutional knowledge of methodologic expertise and access to analytic resources, (2) deep understanding of research needs and methodologic expertise, (3) education of researchers on the role of qualitative and quantitative scientists in the research project, and (4) ongoing evaluation of the analytic resource navigation process to inform improvements. Navigators help researchers determine the type of expertise needed, search the institution to find potential collaborators with that expertise, and document the process to evaluate unmet needs. Although the navigation process can create a basis for an effective solution, some challenges remain, such as having resources to train navigators, comprehensively identifying all potential collaborators, and keeping updated information about resources as methodologists join and leave the institution.

Experiential Learning Methods for Biostatistics Students: A Model for Embedding Student Interns in Academic Health Centers.

This manuscript describes an experiential learning program for future collaborative biostatisticians (CBs) developed within an academic medical center. The program is a collaborative effort between the Biostatistics, Epidemiology, and Research Design (BERD) Methods Core and the Master of Biostatistics (MB) program, both housed in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine and supported in partnership with the Duke Clinical and Translational Science Institute. To date, the BERD Core Training and Internship Program (BCTIP) has formally trained over 80 students to work on collaborative teams that are integrated throughout the Duke School of Medicine. This manuscript focuses on the setting for the training program, the experiential learning model on which it is based, the structure of the program, and lessons learned to date.

Effects of aerobic vs. resistance training on visceral and liver fat stores, liver enzymes, and insulin resistance by HOMA in overweight adults from STRRIDE AT/RT.

While the benefits of exercise are clear, many unresolved issues surround the optimal exercise prescription. Many organizations recommend aerobic training (AT) and resistance training (RT), yet few studies have compared their effects alone or in combination. The purpose of this study, part of Studies Targeting Risk Reduction Interventions Through Defined Exercise-Aerobic Training and/or Resistance Training (STRRIDE/AT/RT), was to compare the effects of AT, RT, and the full combination (AT/RT) on central ectopic fat, liver enzymes, and fasting insulin resistance [homeostatic model assessment (HOMA)]. In a randomized trial, 249 subjects [18-70 yr old, overweight, sedentary, with moderate dyslipidemia (LDL cholesterol 130-190 mg/dl or HDL cholesterol ≤ 40 mg/dl for men or ≤ 45 mg/dl for women)] performed an initial 4-mo run-in period. Of these, 196 finished the run-in and were randomized into one of the following 8-mo exercise-training groups: 1) RT, which comprised 3 days/wk, 8 exercises, 3 sets/exercise, 8-12 repetitions/set, 2) AT, which was equivalent to ∼19.2 km/wk (12 miles/wk) at 75% peak O(2) uptake, and 3) full AT + full RT (AT/RT), with 155 subjects completing the intervention. The primary outcome variables were as follows: visceral and liver fat via CT, plasma liver enzymes, and HOMA. AT led to significant reductions in liver fat, visceral fat, alanine aminotransferase, HOMA, and total and subcutaneous abdominal fat (all P < 0.05). RT resulted in a decrease in subcutaneous abdominal fat (P < 0.05) but did not significantly improve the other variables. AT was more effective than RT at improving visceral fat, liver-to-spleen ratio, and total abdominal fat (all P < 0.05) and trended toward a greater reduction in liver fat score (P < 0.10). The effects of AT/RT were statistically indistinguishable from the effects of AT. These data show that, for overweight and obese individuals who want to reduce measures of visceral fat and fatty liver infiltration and improve HOMA and alanine aminotransferase, a moderate amount of aerobic exercise is the most time-efficient and effective exercise mode.

Exploration of a hypothesized independent association of a common 9p21.3 gene variant and ischemic stroke in patients with and without angiographic coronary artery disease.

BACKGROUND: Single-nucleotide polymorphisms (SNPs) at the chromosome 9p21.3 locus are associated with coronary artery disease (CAD). An association of this genomic region with ischemic stroke independent of its effect on CAD could suggest an additional, stroke-specific pathophysiological relationship. METHODS: Medical record review was used to identify 548 patients without a history of cerebrovascular disease and 232 who had a verified ischemic stroke or transient ischemic attack (TIA) from the Duke CATHGEN biorepository of patients who had a cardiac catheterization. ANCOVA and multivariable logistic regression modeling were performed to determine independent genetic associations between the key chromosome 9p21.3 SNP, rs10757278, and ischemic stroke by comparing allele frequencies between 229 patients with stroke or TIA and an equal number of matched nonstroke controls, adjusting for other risk factors. In a secondary analysis, controls were further divided based on the presence (n = 353) or absence (n = 195) of angiographic CAD. RESULTS: Allele frequencies were similar between patients with and without a history of ischemic stroke in both additive (p = 0.83) and dominant (p = 0.92) models of genetic risk. There was no association between rs10757278 allele frequency and stroke status based on the presence or absence of angiographically demonstrated CAD in nonstroke controls (ANCOVA, p = 0.99). CONCLUSION: These results provide no evidence of a stroke-specific association of the 9p21.3 locus regardless of the presence or absence of angiographic CAD and highlight the need for larger studies to further evaluate this hypothesized relationship.

Associations of Patient Characteristics and Care Setting with Complexity of Specialty Palliative Care Visits.

Background: Information routinely collected during a palliative care consultation request may help predict the level of complexity of that patient encounter. Objectives: We examined whether patient and consultation characteristics, as captured in consultation requests, are associated with the number of unmet palliative care needs that emerge during consultation, as an indicator of complexity. Design: We performed a retrospective cohort analysis of palliative care consultations. Setting: We analyzed quality-of-care data from specialty palliative care consultations contained in the Quality Data Collection Tool of the Global Palliative Care Quality Alliance from 2012 to 2017. Measurements: Using 13 point-of-care assessments of quality of life, symptoms, advance care planning, and prognosis, we created a complexity score ranging from 0 (not complex) to 13 (highest complexity). Using multivariable linear regression, we examined the relationships of consultation setting and patient characteristics with complexity score. Results: Patients in our cohort (N = 3121) had an average complexity score of 6.7 (standard deviation = 3.7). Female gender, nonwhite race, and neurological (e.g., dementia) and noncancer primary diagnosis were associated with increased complexity score. The hospital intensive care unit, compared with the general floor, was associated with higher complexity scores. In contrast, outpatient and residence, compared with the general floor, were associated with lower complexity scores. Conclusion: Patient, disease, and care setting factors known at the time of specialty palliative care consultation request are associated with level of complexity, and they may inform teams about the right service provisions, including time and expertise, required to meet patient needs.

The need for a Serious Illness Digital Ecosystem (SIDE) to improve outcomes for patients receiving palliative and hospice care.

Palliative and hospice care services produce immense benefits for patients living with serious illness and for their families. Due to the national shift toward value-based payment models, health systems and payers share a heightened awareness of the need to incorporate palliative and hospice services into their service mix for seriously ill patient populations. During the last decade, a tremendous amount of capital has been invested to better integrate information technology into healthcare. This includes development of technologies to promote utilization of palliative and hospice services. However, no coordinated strategy exists to link such efforts together to create a cohesive strategy that transitions from identification of patients through receipt of services. A Serious Illness Digital Ecosystem (SIDE) is the intentional aggregation of disparate digital and mobile health technologies into a single system that connects all of the actors involved in serious illness patient care. A SIDE leverages deployed health technologies across disease continuums and geographic locations of care to facilitate the flow of information among patients, providers, health systems, and payers. Five pillars constitute a SIDE, and each one is critical to the success of the system. The 5 pillars of a SIDE are: Identification, Education, Engagement, Service Delivery, and Remote Monitoring. As information technology continues to evolve and becomes a part of the care delivery landscape, it is necessary to develop cohesive ecosystems that inform all parts of the serious illness patient experience and identifies patients for the right services, at the right time.

Methods for training collaborative biostatisticians.

The emphasis on team science in clinical and translational research increases the importance of collaborative biostatisticians (CBs) in healthcare. Adequate training and development of CBs ensure appropriate conduct of robust and meaningful research and, therefore, should be considered as a high-priority focus for biostatistics groups. Comprehensive training enhances clinical and translational research by facilitating more productive and efficient collaborations. While many graduate programs in Biostatistics and Epidemiology include training in research collaboration, it is often limited in scope and duration. Therefore, additional training is often required once a CB is hired into a full-time position. This article presents a comprehensive CB training strategy that can be adapted to any collaborative biostatistics group. This strategy follows a roadmap of the biostatistics collaboration process, which is also presented. A TIE approach (Teach the necessary skills, monitor the Implementation of these skills, and Evaluate the proficiency of these skills) was developed to support the adoption of key principles. The training strategy also incorporates a "train the trainer" approach to enable CBs who have successfully completed training to train new staff or faculty.

A Guide to Reproducibility in Preclinical Research.

Many have raised concerns about the reproducibility of biomedical research. In this Perspective, the authors address this "reproducibility crisis" by distilling discussions around reproducibility into a simple guide to facilitate understanding of the topic.Reproducibility applies both within and across studies. The following questions address reproducibility within studies: "Within a study, if the investigator repeats the data management and analysis, will she get an identical answer?" and "Within a study, if someone else starts with the same raw data, will she draw a similar conclusion?" Contrastingly, the following questions address reproducibility across studies: "If someone else tries to repeat an experiment as exactly as possible, will she draw a similar conclusion?" and "If someone else tries to perform a similar study, will she draw a similar conclusion?"Many elements of reproducibility from clinical trials can be applied to preclinical research (e.g., changing the culture of preclinical research to focus more on transparency and rigor). For investigators, steps toward improving reproducibility include specifying data analysis plans ahead of time to decrease selective reporting; more explicit data management and analysis protocols; and increasingly detailed experimental protocols, which allow others to repeat experiments. Additionally, senior investigators should take greater ownership of the details of their research (e.g., implementing active laboratory management practices, such as random audits of raw data [or at least reduced reliance on data summaries], more hands-on time overseeing experiments, and encouraging a healthy skepticism from all contributors). These actions will support a culture where rigor + transparency = reproducibility.