Complications among colorectal cancer survivors: SF-6D preference-weighted quality of life scores

Background Societal preference-weighted health-related quality of life (HRQOL) scores enable comparing multi-dimensional health states across diseases and treatments for research and policy. Objective To assess the effects of living with a permanent intestinal stoma, compared to a major bowel resection, among colorectal cancer (CRC) survivors. Research Design Cross-sectional multivariate linear regression analysis to explain preference-weighted HRQOL scores. Subjects Six-hundred-forty CRC survivors (≥5 years) from three group-model HMOs; ostomates and non-ostomates with colorectal resections for CRC were matched on gender, age (±5 years), time since diagnosis, and tumor site (rectum vs. colon). Measures SF-6D scoring system applied to Medical Outcomes Study Short Form-36 version 2 (SF-36v2); City of Hope Quality of Life-Ostomy (mCOH-QOL-O); Charlson-Deyo comorbidity index. Methods Survey of CRC survivors linked to respondents’ clinical data extracted from HMO files. Results Response rate was 52%. Ostomates and non-ostomates had similar sociodemographic characteristics. Mean SF-6D score was 0.69 for ostomates, compared to 0.73 for non-ostomates (p <.001), but other factors explained this difference. Complications of initial cancer surgery, and prior-year comorbidity burden and hospital use were negatively associated with SF-6D scores, while household income was positively associated. Conclusions CRC survivors’ SF-6D scores were not associated with living with a permanent ostomy after other factors were taken into account. Surgical complications, comorbidities, and metastatic disease lowered the preference-weighted HRQOL of CRC survivors with and without ostomies. Further research to understand and reduce late complications from CRC surgeries as well as associated depression is warranted

Generating a taxonomy for genetic conditions relevant to reproductive planning

As genome or exome sequencing (hereafter genome-scale sequencing) becomes more integrated into standard care, carrier testing is an important possible application. Carrier testing using genome-scale sequencing can identify a large number of conditions, but choosing which conditions/genes to evaluate as well as which results to disclose can be complicated. Carrier testing generally occurs in the context of reproductive decision-making and involves patient values in a way that other types of genetic testing may not. The Kaiser Permanente Clinical Sequencing Exploratory Research program is conducting a randomized clinical trial of preconception carrier testing that allows participants to select their preferences for results from among broad descriptive categories rather than selecting individual conditions. This paper describes 1) the criteria developed by the research team, the return of results committee (RORC), and stakeholders for defining the categories; 2) the process of refining the categories based on input from patient focus groups and validation through a patient survey; and, 3) how the RORC then assigned specific gene-condition pairs to taxonomy categories being piloted in the trial. The development of four categories (serious, moderate/mild, unpredictable, late onset) for sharing results allows patients to select results based on their values without separately deciding their interest in knowing their carrier status for hundreds of conditions. A fifth category, lifespan limiting, was always shared. The lessons learned may be applicable in other results disclosure situations, such as incidental findings

Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine

Despite rapid technical progress and demonstrable effectiveness for some types of diagnosis and therapy, much remains to be learned about clinical genome and exome sequencing (CGES) and its role within the practice of medicine. The Clinical Sequencing Exploratory Research (CSER) consortium includes 18 extramural research projects, one National Human Genome Research Institute (NHGRI) intramural project, and a coordinating center funded by the NHGRI and National Cancer Institute. The consortium is exploring analytic and clinical validity and utility, as well as the ethical, legal, and social implications of sequencing via multidisciplinary approaches; it has thus far recruited 5,577 participants across a spectrum of symptomatic and healthy children and adults by utilizing both germline and cancer sequencing. The CSER consortium is analyzing data and creating publically available procedures and tools related to participant preferences and consent, variant classification, disclosure and management of primary and secondary findings, health outcomes, and integration with electronic health records. Future research directions will refine measures of clinical utility of CGES in both germline and somatic testing, evaluate the use of CGES for screening in healthy individuals, explore the penetrance of pathogenic variants through extensive phenotyping, reduce discordances in public databases of genes and variants, examine social and ethnic disparities in the provision of genomics services, explore regulatory issues, and estimate the value and downstream costs of sequencing. The CSER consortium has established a shared community of research sites by using diverse approaches to pursue the evidence-based development of best practices in genomic medicine

Biobank Recruitment: Motivations for Nonparticipation

Molecular data, essential for genomics research, can be captured more efficiently in large-scale, population-based biobanks of genetic material rather than by individual studies. Biobanks also offer improved quality and reliability of genetic samples and access through automated sample retrieval. However, it is challenging to adequately inform participants of the broad nature of the research and participation risks and benefits. In addition, recent studies suggest concerns about data sharing and return of research results, or future research topics (eg, stereotypical or potentially stigmatizing traits). We evaluated the interest in participating in a biobank and reasons for nonparticipation

Partnering With Patient Advisors in the PORTAL Clinical Data Research Network

Background/Aims: PORTAL, composed of Kaiser Permanente, Group Health Cooperative, Health Partners and Denver Health, is a PCORnet network focusing start-up efforts on identifying what matters most for patients with obesity, colorectal cancer and congenital heart disease (three cohorts) and building capacity to conduct patient-centered research to address those priorities. This presentation will describe the Patient Engagement Council (PEC) and an associated Online Advisor group guiding PORTAL’s development. Methods: The PEC is composed of 10 patients representing each of the cohorts as well as three representatives from cohort-specific advocacy organizations. PEC members attend an in-person meeting for orientation/team-building and subsequently offer guidance through 10 webinars, emails and conference calls. PORTAL seeks PEC members’ input about how to engage patients in research, identify research questions and methods that matter to patients, and facilitate communication between PORTAL and broader audiences. Eighteen online advisors are being recruited to help PORTAL establish three cohort-specific online Smart Patients communities –– where patients and caregivers learn from each other about the latest science, treatments and patient concerns. Online advisors work with Smart Patients to identify key topics and develop early content for the online communities’ discussion boards. Results: Eligible members were identified within each health system through clinical and operational liaisons and were then interviewed by PORTAL staff. Selected candidates were invited to join as PEC members or online advisors. All of the PEC members have been recruited, completed the orientation, and participated in the first webinar focused on cohort-specific survey questions/modes of survey administration. The successes and challenges of recruitment, hosting in-person and online meetings, and PEC contributions to PORTAL’s start-up phase will be presented. Prior to the conference, all 18 online advisors will have been recruited and completed their work setting up online communities. The benefits and challenges of engaging online advisors will be presented and the online communities will be described. Discussion: This presentation of the process and initial outcomes of engaging patients in the development of a large multisite network will have broad significance as a model for engaging patients in research network development

Partnering With Patient Advisors in the PORTAL Clinical Data Research Network

Background/Aims: PORTAL, composed of Kaiser Permanente, Group Health Cooperative, Health Partners and Denver Health, is a PCORnet network focusing start-up efforts on identifying what matters most for patients with obesity, colorectal cancer and congenital heart disease (three cohorts) and building capacity to conduct patient-centered research to address those priorities. This presentation will describe the Patient Engagement Council (PEC) and an associated Online Advisor group guiding PORTAL’s development. Methods: The PEC is composed of 10 patients representing each of the cohorts as well as three representatives from cohort-specific advocacy organizations. PEC members attend an in-person meeting for orientation/team-building and subsequently offer guidance through 10 webinars, emails and conference calls. PORTAL seeks PEC members’ input about how to engage patients in research, identify research questions and methods that matter to patients, and facilitate communication between PORTAL and broader audiences. Eighteen online advisors are being recruited to help PORTAL establish three cohort-specific online Smart Patients communities –– where patients and caregivers learn from each other about the latest science, treatments and patient concerns. Online advisors work with Smart Patients to identify key topics and develop early content for the online communities’ discussion boards. Results: Eligible members were identified within each health system through clinical and operational liaisons and were then interviewed by PORTAL staff. Selected candidates were invited to join as PEC members or online advisors. All of the PEC members have been recruited, completed the orientation, and participated in the first webinar focused on cohort-specific survey questions/modes of survey administration. The successes and challenges of recruitment, hosting in-person and online meetings, and PEC contributions to PORTAL’s start-up phase will be presented. Prior to the conference, all 18 online advisors will have been recruited and completed their work setting up online communities. The benefits and challenges of engaging online advisors will be presented and the online communities will be described. Discussion: This presentation of the process and initial outcomes of engaging patients in the development of a large multisite network will have broad significance as a model for engaging patients in research network development

Adaptive Resources and Unmet Needs Related to Ostomy Self-Care Among Long-Term Rectal Cancer Survivors

Background/Aims: Surgical treatment for rectal cancer can result in an intestinal ostomy that requires lifelong adaptation and investment of physical, cognitive and financial resources. However, little is known about the prevalence of functional limitation related to ostomies among long-term cancer survivors. Methods: In 2010–2011, we mailed questionnaires to 313 long-term rectal cancer survivors with ostomies (≥5 years postdiagnosis) from two Kaiser regions, Northern California and Northwest. Potential participants (KP members age ≥18 years) were identified through tumor registries. The response rate was 66% (183/277). Data from the electronic medical record included hernia diagnoses and comorbidity score. Results: Of respondents with ostomy who reported wearing a pouch (not irrigating), 64% (103/160) were male. Mean age at survey was 75 years. Health status: Health problems that could affect ostomy care capacity were fairly common. Mean body mass index (BMI) at time of survey was 26.76 (standard deviation 5.42), with 70% (105/150) of respondents reporting a significant change (+/-) in BMI since time of surgery; 28% (45/160) of respondents had a hernia diagnosis at some time after their surgery. Adaptive resources: Of participants who reported paying for their ostomy supplies, 55% (39/71) had at least some difficulty paying the cost. Women were significantly more likely to report difficulty than men (P=0.011). Fifteen percent (23/155) reported receiving help with their ostomy care. While 63% (100/160) of respondents were partnered at time of survey, women were significantly less likely to be partnered than men (p\u3c 0.001). Functional limitations related to ostomy: 27% (39/147) of respondents reported changing their ostomy wafer or appliance more often than every 3 days, 27% (41/154) had problems with ostomy leakage, 25% (39/155) had problems with the skin around the ostomy, and 21% (33/155) reported having difficulty caring for their ostomy. Discussion: Most rectal cancer survivors have health conditions that can worsen impairment and undermine adaptive capacity related to ostomy care and report difficulty paying for their ostomy supplies. Approximately 25% of survivors experienced limitations across multiple domains of ostomy-related functioning, yet only 14% reported receiving assistance with ostomy care. Further research should explore whether/how gender and partnered status influence resources or unmet needs for ostomy care assistance

Association between treatment of superficial bladder cancer and 10-year mortality in older adults with multiple chronic conditions

Background: Multiple chronic conditions (MCC) are common among older patients with cancer; however, the exclusion of these patients from clinical trials has resulted in scarce knowledge concerning outcomes, resulting in variations in treatment. Superficial bladder cancer (SBC) disproportionately affects older adults, yet to the authors’ knowledge few studies to date have examined whether treatment improves long-term survival. In the current study, the authors evaluated the association between treatment of SBC and 10-year mortality in medically complex older adults. Methods: The authors identified 1800 older (aged ≥60 years) patients with SBC (American Joint Committee on Cancer stage ≤I) from 2 community-based health systems who received treatment (bladder instillation and/or transurethral resection) or observation. Cox proportional hazards regression was performed adjusting for age, sex, race, health system, stage of disease/grade, and MCC (≥2 baseline chronic conditions). Propensity score analysis using stabilized inverse probability of treatment weights was used to compare 10-year mortality in the 2 treatment groups with adjustment for covariates. Results: Overall, 1485 patients (82.5%) and 315 patients (17.5%) received treatment and observation, respectively. In unweighted multivariable analysis, treatment was associated with a 30% reduction in death (adjusted hazard ratio [HR], 0.70; 95% confidence interval [95% CI], 0.58-0.85 [P\u3c.01]) and MCC with a 72% increase in death (adjusted HR, 1.72; 95% CI, 1.44-2.05 [P\u3c.01]). Weighted analysis with adjustment (doubly robust) also demonstrated a survival benefit for treatment (adjusted HR, 0.66; 95% CI, 0.52-0.84 [P\u3c.01]). Conclusions: The results of the current study demonstrated a clinically meaningful association between cancer treatment and survival benefit in older, medically complex patients with SBC, even after adjustment for medical complexity. These data provide a foundation for future work aimed at personalizing the treatment guidance of older patients with cancer with MCC