ABSTRACT
PURPOSE: The ClinGen Actionability Working Group (AWG) developed an evidence-based framework to generate actionability reports and scores of gene-condition pairs in the context of secondary findings from genome sequencing. Here we describe the expansion of the framework to include actionability assertions. METHODS: Initial development of the actionability rubric was based on previously scored adult gene-condition pairs and individual expert evaluation. Rubric refinement was iterative and based on evaluation, feedback, and discussion. The final rubric was pragmatically evaluated via integration into actionability assessments for 27 gene-condition pairs. RESULTS: The resulting rubric has a 4-point scale (limited, moderate, strong, and definitive) and uses the highest-scoring outcome-intervention pair of each gene-condition pair to generate a preliminary assertion. During AWG discussions, predefined criteria and factors guide discussion to produce a consensus assertion for a gene-condition pair, which may differ from the preliminary assertion. The AWG has retrospectively generated assertions for all previously scored gene-condition pairs and are prospectively asserting on gene-condition pairs under assessment, having completed over 170 adult and 188 pediatric gene-condition pairs. CONCLUSION: The AWG expanded its framework to provide actionability assertions to enhance the clinical value of their resources and increase their utility as decision aids regarding return of secondary findings.
Subject(s)
Evidence-Based Medicine , Humans , Evidence-Based Medicine/methods , Genetic Testing/methods , Incidental Findings , Whole Genome SequencingABSTRACT
PURPOSE: With increasing utilization of genetic testing, sharing genetic information can become part of general family health communication while providing biological relatives with important information about their own genetic risk. Importantly, little is known about motivations for and barriers to family communication of genetic information in historically underserved populations. METHODS: Using mixed methods, we explored patient experiences with family communication in a study population of English- and Spanish-speaking adults aged 18 to 49 years, enriched for participants from historically underserved backgrounds. Risk screening for hereditary cancer guided genetic testing for cancer risk genes and other medically actionable findings. RESULTS: Most participants overall (91%), including most with normal findings (89%), shared or planned to share their results with relatives. Common motivations for sharing results were to give relatives information about their genetic risk and because the participant thought the results were interesting. Reasons for not sharing were limited contact with relatives, perceptions of limited clinical utility for relatives, and concern that discussion of genetic information was stigmatized or taboo. CONCLUSION: Results demonstrate high rates of sharing genetic information, indicate motivations for sharing go beyond facilitating genetic testing for relatives, and suggest general willingness to share genetic information as part of family health communication.
Subject(s)
Genetic Testing , Neoplasms , Adult , Humans , Genetic Testing/methods , Communication , Neoplasms/genetics , Family , Surveys and Questionnaires , Genetic Predisposition to DiseaseABSTRACT
Underserved patients face substantial barriers to receiving cancer genetic services. The Cancer Health Assessments Reaching Many (CHARM) study evaluated ways to increase access to genetic testing for individuals in underserved populations at risk for hereditary cancer syndromes (HCS). Here, we report the successful implementation of CHARM in a low-resource environment and the development of sustainable processes to continue genetic risk assessment in this setting. The research team involved key clinical personnel and patient advisors at Denver Health to provide input on study methods and materials. Through iterative and collaborative stakeholder engagement, the team identified barriers and developed solutions that would both facilitate participation in CHARM and be feasible to implement and sustain long term in clinical care. With a focus on infrastructure building, educational modules were developed to increase awareness among referring providers, and standard methods of identifying and managing HCS patients were implemented in the electronic medical record. Three hundred sixty-four DH patients successfully completed the risk assessment tool within the study, and we observed a sustained increase in referrals to genetics for HCS (from 179 in 2017 to 427 in 2021 post-intervention). Implementation of the CHARM study at a low-resourced safety net health system resulted in sustainable improvements in access to cancer genetic risk assessment and services that continue even after the study ended.Trial registration NCT03426878.
ABSTRACT
BACKGROUND: All families experience financial and time costs related to caring for their children's health. Understanding the economic burden faced by families of children with chronic health conditions (CHC) is crucial for designing effective policies to support families. METHODS: In this prospective study we used electronic health records to identify children between 3 and 17 years old with autism spectrum disorder (ASD), asthma, or neither (control) from three Kaiser Permanente regions and several community health centers in the OCHIN network. We oversampled children from racial and ethnic minority groups. Parent/guardian respondents completed surveys three times, approximately four months apart. The surveys included the Family Economic Impact Inventory (measuring financial, time, and employment costs of caring for a child's health), and standardized measures of children's quality of life, behavioral problems, and symptom severity for children with ASD or asthma. We also assessed parenting stress and parent physical and mental health. All materials were provided in English and Spanish. RESULTS: Of the 1,461 families that enrolled (564 ASD, 468 asthma, 429 control), children were predominantly male (79%), with a mean age of 9.0 years, and racially and ethnically diverse (43% non-Hispanic white; 22% Hispanic; 35% Asian, Black, Native Hawaiian, or another race/ethnicity). The majority of survey respondents were female (86%), had a college degree (62%), and were married/partnered (79%). ASD group respondents were less likely to be employed (73%) than those in the asthma or control groups (both 80%; p = .023). Only 32% of the control group reported a household income ≤ $4,000/month compared with 41% of asthma and 38% of ASD families (p = .006). CONCLUSIONS: Utilizing a novel measure assessing family economic burden, we successfully collected survey responses from a large and diverse sample of families. Drawing upon the conceptual framework, survey measures, and self-report data described herein we will conduct future analyses to examine the economic burdens related to CHC and the incremental differences in these burdens between health groups. This information will help policy makers to design more equitable health and social policies that could reduce the burden on families.
Subject(s)
Autism Spectrum Disorder , Ethnicity , Child , Humans , Male , Female , Child, Preschool , Adolescent , Child Health , Quality of Life , Prospective Studies , Minority GroupsABSTRACT
Parents of children with autism spectrum disorder (ASD) and other chronic health conditions often face exceptional caregiving demands that can lead to challenges related to maintaining and succeeding in employment. Detailed information on the specific ways in which these health conditions impact parent employment could aid in designing equitable, effective policies to support families. The r-Kids study used electronic health records to identify three groups of children: those with ASD, asthma, or neither condition (control), from several health care systems. We oversampled racial and ethnic minorities and matched the asthma and control groups to the age and sex distribution of the ASD group. Parents completed three online surveys over the course of a year to measure annual employment outcomes. Surveys included the Family Economic Impact Inventory (measuring employment impacts) and measures of quality of life and symptom severity. All materials were provided in English and Spanish. The study enrolled 1461 families (564 ASD, 468 asthma, 429 control). Youth were 3-16.5 years old and predominantly male (79%). The sample was diverse (43% non-Hispanic White; 35% non-Hispanic Asian, Black, Native Hawaiian, or Other; and 21% Hispanic ethnicity). Parents of children with ASD were significantly less likely to be employed than parents of youth with asthma and control combined (OR: 14.2, p < 0.001), and were more likely to have other difficulties with employment and productivity while at work. Public and employer policies to help mitigate these impacts could aid families in managing care for youth with ASD.
Subject(s)
Asthma , Autism Spectrum Disorder , Child , Adolescent , Humans , Male , Child, Preschool , Female , Autism Spectrum Disorder/diagnosis , Quality of Life , Parents , EmploymentABSTRACT
Large research teams and consortia present challenges for authorship. The number of disciplines involved in the research can further complicate approaches to manuscript development and leadership. The CHARM team, representing a multi-disciplinary, multi-institutional genomics implementation study, participated in facilitated discussions inspired by team science methodologies. The discussions were centered on team members' past experiences with authorship and perspectives on authorship in a large research team context. Team members identified challenges and opportunities that were used to create guidelines and administrative tools to support manuscript development. The guidelines were organized by the three values of equity, inclusion, and efficiency and included eight principles. A visual dashboard was created to allow all team members to see who was leading or involved in each paper. Additional tools to promote equity, inclusion, and efficiency included providing standardized project management for each manuscript and making "concept sheets" for each manuscript accessible to all team members. The process used in CHARM can be used by other large research teams and consortia to equitably distribute lead authorship opportunities, foster coauthor inclusion, and efficiently work with large authorship groups.
ABSTRACT
PURPOSE: Effective approaches to communicate genomic information are needed to ensure equitable care. In a randomized controlled superiority trial, we tested a novel practice model that aims to make genetic counseling inclusive, by making the communication accessible, relational, and actionable (ARIA). METHODS: In total, 696 English- and Spanish-speaking patients aged 18 to 49 years, enriched for individuals from historically underserved backgrounds, were randomized in 1:1 ratio to ARIA or usual care. Primary outcomes were accuracy of recall, communication satisfaction, and perceived understanding. In total, 33 participants completed qualitative interviews. RESULTS: Recall and understanding were high for all participants. ARIA participants scored higher on the relationship scale of communication satisfaction (mean difference = 0.09, 95% CI = <0.01 to 0.17). Moderator analyses of communication satisfaction showed that those with lower health literacy reported less communication difficulty in ARIA and those using medical interpreters reported greater communication ease in ARIA. No significant difference was found on other primary and secondary outcomes. Qualitative data enhanced understanding of how and why ARIA can be effective. CONCLUSION: This study provides evidence that a genetic counseling intervention that focuses on specific communication skills to enhance relationship-building, patient engagement, and comprehension can be effective with all patients and may be especially valuable for patients of lower health literacy and Spanish-speakers who use a medical interpreter.
Subject(s)
Communication , Genetic Counseling , Health Literacy , Humans , Data Collection , Genetic Counseling/methods , Hispanic or LatinoABSTRACT
PURPOSE: Synthesis and curation of evidence regarding the clinical actionability of secondary findings (SFs) from genome-scale sequencing are needed to support decision-making on reporting of these findings. To assess actionability of SFs in children and adolescents, the Clinical Genome Resource established the Pediatric Actionability Working Group (AWG). METHODS: The Pediatric AWG modified the framework of the existing Adult AWG, which included production of summary reports of actionability for genes and associated conditions and consensus actionability scores for specific outcome-intervention pairs. Modification of the adult framework for the pediatric setting included accounting for special considerations for reporting presymptomatic or predictive genetic findings in the pediatric context, such as maintaining future autonomy by not disclosing conditions not actionable until adulthood. The Pediatric AWG then applied this new framework to genes and associated conditions with putative actionability. RESULTS: As of September 2021, the Pediatric AWG applied the new framework to 70 actionability topics representing 143 genes. Reports and scores are publicly available at www.clinicalgenome.org. CONCLUSION: The Pediatric AWG continues to curate gene-condition topics and build an evidence-based resource, supporting clinical communities and decision-makers with policy development on the return of SFs in pediatric populations.
Subject(s)
Genetic Testing , Research Report , Adolescent , Adult , Child , Chromosome Mapping , HumansABSTRACT
OBJECTIVE: Emotional and behavioral problems (EBPs) may co-occur with autism spectrum disorder (ASD) and impair children's functioning beyond autism symptomatology. We compared the prevalence of EBPs in youths with or without ASD and evaluated their unique contribution to impairment in ASD. METHODS: We surveyed 1267 children (79.4% boys, mean age: 9.2 years, range: 3-17) recruited at 3 sites in Kaiser Permanente and OCHIN primary care clinical networks, with confirmed International Classification of Diseases-10th ed. diagnosis of ASD (N = 564), asthma (N = 468), or neither (N = 429). Children from the 2 comparison groups were age-matched and sex-matched to the ASD group. EBPs and impairment were measured by the Strengths and Difficulties Questionnaire and autism symptomatology by the Social Responsiveness Scale in the ASD group only. RESULTS: EBPs and impairment mean scores were significantly (p < 0.001) higher in participants with ASD compared with children from the 2 comparison groups, across sexes and age groups, with no significant difference between the asthma and control groups. Among children with ASD, both EBPs and autistic symptoms were significantly correlated with impairment (r = 0.64 and r = 0.65, respectively) and explained a significant proportion of impairment variance (R2 = 0.525; p < 0.001) in multiple linear regression. In the relative importance analysis, EBPs and autistic symptoms explained comparable proportions of impairment variance (46% and 52%, respectively) with no significant difference between their relative weights (mean difference: 0.03; 95% confidence interval: -0.049 to 0.114). CONCLUSION: Among youth with ASD, high levels of EBPs impair daily functioning as much as autistic symptoms. Systematic detection and management of EBPs may improve functioning and outcomes in youth with ASD.
Subject(s)
Asthma , Autism Spectrum Disorder , Autistic Disorder , Problem Behavior , Adolescent , Autism Spectrum Disorder/complications , Child , Female , Humans , Male , PrevalenceABSTRACT
PURPOSE: To evaluate whether limited participation in life activities is associated with quality of life (QOL) in rectal cancer survivors, and if so, whether this association is independent of bowel function difficulties. METHODS: We surveyed rectal cancer survivors from four healthcare systems about their QOL, bowel function, and participation in life activities. Additional demographic and clinical variables were extracted from the electronic health record. We examined independent associations between bowel function, participation in life activities, and QOL, controlling for potential confounders. We also identified factors, including ostomy status, that correlate with participation in life activities. RESULTS: Of the 527 respondents, 52% were male, 80% were non-Hispanic white, and the mean age was 63. In fully adjusted models for all rectal cancer survivors, participation in life activities was positively associated with QOL, while bowel function was not. Bowel function retained an independent association with QOL for those who previously had an ostomy and were therefore more likely to have a low rectal anastomosis. Lower participation in life activities was correlated with lower self-reported physical and cognitive function, younger age, financial difficulty, and being non-Hispanic white. CONCLUSIONS: Rectal cancer survivors' participation in life activities was strongly associated with QOL, even when controlling for numerous confounders, including bowel function. Identifying ways to improve participation in life activities may be critical to developing rehabilitative and other supportive interventions that optimize QOL among rectal cancer survivors.
Subject(s)
Cancer Survivors , Ostomy , Rectal Neoplasms , Humans , Male , Middle Aged , Quality of Life/psychology , SurvivorsABSTRACT
BACKGROUND: Informatics tools within electronic health records (EHRs)-for example, data rosters and clinical reminders-can help disseminate care guidelines into clinical practice. Such tools' adoption varies widely, however, possibly because many primary care providers receive minimal training in even basic EHR functions. OBJECTIVES: This mixed-methods evaluation of a pilot training program sought to identify factors to consider when providing EHR use optimization training in community health centers (CHCs) as a step toward supporting CHC providers' adoption of EHR tools. METHODS: In spring 2018, we offered 10 CHCs a 2-day, 16-hour training in EHR use optimization, provided by clinician trainers, and customized to each CHC's needs. We surveyed trainees pre- and immediately post-training and again 3 months later. We conducted post-training interviews with selected clinic staff, and conducted a focus group with the trainers, to assess satisfaction with the training, and perceptions of how it impacted subsequent EHR use. RESULTS: Six CHCs accepted and received the training; 122 clinic staff members registered to attend, and most who completed the post-training survey reported high satisfaction. Three months post-training, 80% of survey respondents said the training had changed their daily EHR use somewhat or significantly. CONCLUSION: Factors to consider when planning EHR use optimization training in CHCs include: CHCs may face barriers to taking part in such training; it may be necessary to customize training to a given clinic's needs and to different trainees' clinic roles; identifying trainees' skill level a priori would help but is challenging; in-person training may be preferable; and inclusion of a practice coach may be helpful. Additional research is needed to identify how to provide such training most effectively.
ABSTRACT
BACKGROUND: In the United States, the prevalence of anemia, iron deficiency (ID), and iron-deficiency anemia (IDA) during pregnancy remains largely unknown as data at the national or state level are limited or nonexistent, respectively. OBJECTIVES: In an effort to identify opportunities to improve maternal health surveillance, we assessed the feasibility of anemia, ID, and IDA surveillance among first-trimester pregnancies using electronic health records (EHRs). METHODS: We identified pregnancies among Kaiser Permanente Northwest members aged ≥18 y during 2005-2016 with first-trimester prenatal care (n = 41,991). Earliest laboratory test results for hemoglobin or hematocrit and ferritin were selected. We describe the proportion of pregnancies screened for and the prevalence of anemia, ID, and IDA; the concordance of anemia status by hemoglobin compared with hematocrit; and the proportion of pregnancies with laboratory-confirmed anemia that also had an International Classification of Diseases diagnostic code related to anemia. RESULTS: Identified pregnancies included women who were 73.1% non-Hispanic (NH) white, 11.5% Hispanic, 8.5% NH Asian/Pacific Islander, and 2.9% NH black. Hemoglobin and hematocrit results were available for 92.7% (n = 38,923) pregnancies. Anemia prevalence was 2.7% (n = 1045) based on hemoglobin <11.0 g/dL or hematocrit <33%; 45.2% of anemia cases had both low hemoglobin and low hematocrit. Among pregnancies with anemia, 18.9% (n = 197) had a ferritin result; of those, 48.2% had ID (ferritin <15 µg/L). In pregnancies without anemia, 3.4% (n = 1275) had a ferritin result; of those, 23.5% had ID. Based on 1472 pregnancies with both anemia and ID assessed, prevalence of ID and IDA was 26.8% and 6.5%, respectively; estimates likely represent selective screening. CONCLUSIONS: EHR data have potential to monitor anemia prevalence and trends in health systems where prenatal anemia screening is nearly universal. However, if iron assessment is not routine, then representative estimates of ID or IDA are unattainable.
Subject(s)
Anemia, Iron-Deficiency , Anemia , Iron Deficiencies , Adolescent , Adult , Anemia/epidemiology , Anemia, Iron-Deficiency/epidemiology , Electronic Health Records , Female , Hemoglobins/analysis , Humans , Pregnancy , Prevalence , Young AdultABSTRACT
OBJECTIVES: Prepregnancy body mass index (BMI) and gestational weight gain (GWG) are known determinants of maternal and child health; calculating both requires an accurate measure of prepregnancy weight. We compared self-reported prepregnancy weight to measured weights to assess reporting bias by maternal and clinical characteristics. METHODS: We conducted a retrospective cohort study among pregnant women using electronic health records (EHR) data from Kaiser Permanente Northwest, a non-profit integrated health care system in Oregon and southwest Washington State. We identified women age ≥ 18 years who were pregnant between 2000 and 2010 with self-reported prepregnancy weight, ≥ 2 measured weights between ≤ 365-days-prior-to and ≤ 42-days-after conception, and measured height in their EHR. We compared absolute and relative difference between self-reported weight and two "gold-standards": (1) weight measured closest to conception, and (2) usual weight (mean of weights measured 6-months-prior-to and ≤ 42-days-after conception). Generalized-estimating equations were used to assess predictors of misreport controlling for covariates, which were obtained from the EHR or linkage to birth certificate. RESULTS: Among the 16,227 included pregnancies, close agreement (± 1 kg or ≤ 2%) between self-reported and closest-measured weight was 44% and 59%, respectively. Overall, self-reported weight averaged 1.3 kg (SD 3.8) less than measured weight. Underreporting was higher among women with elevated BMI category, late prenatal care entry, and pregnancy outcome other than live/stillbirth (p < .05). Using self-reported weight, BMI was correctly classified for 91% of pregnancies, but ranged from 70 to 98% among those with underweight or obesity, respectively. Results were similar using usual weight as gold standard. CONCLUSIONS FOR PRACTICE: Accurate measure of prepregnancy weight is essential for clinical guidance and surveillance efforts that monitor maternal health and evaluate public-health programs. Identification of characteristics associated with misreport of self-reported weight can inform understanding of bias when assessing the influence of prepregnancy BMI or GWG on health outcomes.
Subject(s)
Gestational Weight Gain , Body Mass Index , Child , Female , Humans , Infant, Newborn , Overweight , Pregnancy , Pregnancy Outcome/epidemiology , Retrospective Studies , Self ReportABSTRACT
BACKGROUND: Genitourinary symptoms are common in postmenopausal women and adversely affect the quality of life. National surveys and data collected from our healthcare system indicate that postmenopausal women with the genitourinary syndrome of menopause often fail to receive appropriate diagnosis or treatment. OBJECTIVE: To promote greater detection and treatment of the genitourinary syndrome of menopause, we created and tested a clinician-focused health system intervention that included clinician education sessions and a suite of evidence-based electronic health record tools. STUDY DESIGN: Using a cluster-randomized design, we allocated primary care (16) and gynecology (6) clinics to the intervention or control group. From September to November 2014, we provided training about the diagnosis and treatment of genitourinary syndrome of menopause in face-to-face presentations at each intervention clinic and in an online video. We developed clinical decision support tools in the electronic health record that contained an evidence-based, point-of-care knowledge resource, a standardized order set, and a checklist of patient education materials for the patient's after visit summary. The tools aimed to facilitate accurate diagnostic coding and prescribing (SmartSet, SmartRx) along with relevant patient information (SmartText). Clinicians who only performed visits at control clinics received no training or notification about the tools. Our primary outcome was vulvovaginal diagnoses made at well visits for women at the age of 55 years and older from November 15, 2014 to November 15, 2015. We also assessed urinary diagnoses, vaginal estrogen prescriptions, and use of the electronic tools. There was departmental support for the intervention but no prioritization within the healthcare system to incentivize change. RESULTS: In the 1-year period, 386 clinicians performed 14,921 well visits for women at the age of 55 years and older. Among the 190 clinicians who performed well visits in the intervention clinics, 109 (57.4%) completed either in-person or online educational training. The proportion of visits that included a vulvovaginal (7.2% vs 5.8%; odds ratio, 1.27; 95% confidence interval, 0.65-2.51) or urinary diagnosis (2.5% vs 3.1%; odds ratio, 0.79; 95% confidence interval, 0.55-1.13) or vaginal estrogen prescription (4.5% vs 3.7%; odds ratio, 1.24; 95% confidence interval, 0.63-2.46) did not differ between study arms. There was a significant interaction for primary care and gynecology, which revealed more vulvovaginal diagnoses by gynecology but not primary care intervention clinics (odds ratio, 1.63; 95% confidence interval, 1.15-2.31), but there was no significant interaction for prescriptions. Clinicians in the intervention clinics were more likely to use decision support tools than those in control clinics-SmartSet (22.2% vs 1.5%; odds ratio, 18.8; 95% confidence interval, 5.5-63.8) and SmartText for patient information (38.0% vs 24.4%; odds ratio, 1.91; 95% confidence interval, 1.10-3.34). A per-protocol analysis revealed similar findings. CONCLUSION: Overall, the intervention did not lead to more diagnoses or prescription therapy for postmenopausal genitourinary symptoms but did result in greater distribution of patient information. Gynecology clinicians were more likely to address genitourinary symptoms generally and were more likely to make a vulvovaginal diagnosis after the intervention. Further efforts for improving care should consider ongoing clinician education beginning with enhanced menopause curricula in residency training. Additional interventions to consider include greater access for postmenopausal women to gynecologic care, addressing treatment barriers, and development of national performance metrics.
Subject(s)
Decision Support Techniques , Gynecology , Menopause , Practice Patterns, Physicians' , Primary Health Care , Urogenital System , Urologic Diseases/diagnosis , Vulvovaginitis/diagnosis , Adult , Female , Humans , Middle Aged , Oregon , Syndrome , Urologic Diseases/drug therapy , Vulvovaginitis/drug therapy , WashingtonABSTRACT
PURPOSE: The Bladder Cancer Quality of Life Study collected detailed and sensitive patient-reported outcomes from bladder cancer survivors in the period after bladder removal surgery, when participation in survey research may present a burden. This paper describes the study recruitment methods and examines the response rates and patterns of missing data. METHODS: Detailed surveys focusing on quality of life, healthcare decision-making, and healthcare expenses were mailed to patients 5-7 months after cystectomy. We conducted up to 10 follow-up recruitment calls. We analyzed survey completion rates following each contact in relation to demographic and clinical characteristics, and patterns of missing data across survey content areas. RESULTS: The overall response rate was 71% (n = 269/379). This was consistent across patient clinical characteristics; response rates were significantly higher among patients over age 70 and significantly lower among racial and ethnic minority patients compared to non-Hispanic white patients. Each follow-up contact resulted in marginal survey completion rates of at least 10%. Rates of missing data were low across most content areas, even for potentially sensitive questions. Rates of missing data differed significantly by sex, age, and race/ethnicity. CONCLUSIONS: Despite the effort required to participate in research, this population of cancer survivors showed willingness to share detailed information about quality of life, health care decision-making, and expenses, soon after major cancer surgery. Additional contacts were effective at increasing participation. Response patterns differed by race/ethnicity and other demographic factors. Our data collection methods show that it is feasible to gather detailed patient-reported outcomes during this challenging period.
Subject(s)
Cancer Survivors/statistics & numerical data , Cystectomy/economics , Cystectomy/psychology , Quality of Life/psychology , Surveys and Questionnaires/statistics & numerical data , Urinary Bladder Neoplasms/surgery , Adult , Decision Making , Delivery of Health Care/economics , Ethnicity , Female , Humans , Male , Middle Aged , Minority Groups , Patient Reported Outcome Measures , Urinary Bladder/surgery , Urinary Bladder Neoplasms/economics , Urinary Bladder Neoplasms/psychology , Young AdultABSTRACT
PURPOSE: Patients who undergo cystectomy due to bladder cancer can elect an ileal conduit or a neobladder for urinary diversion. Decision regret related to this choice is an important and undesirable patient reported outcome. Our objective was to compare the severity of decision regret experienced by patients with a neobladder vs an ileal conduit. MATERIALS AND METHODS: We analyzed data from a longitudinal cohort study of patients who underwent cystectomy from 2013 to 2015. We applied multivariable linear regression to examine associations of the urinary diversion method (neobladder vs ileal conduit) with decision regret measured with the DRS (Decision Regret Scale) 6 and 18 months after cystectomy. Covariates included demographic and clinical characteristics, health care utilization and complications after cystectomy, quality of life and factors related to the decision making process, including informed and shared decision making, and goal concordance. RESULTS: Of the 192 patients in our cohort 141 received an ileal conduit and 51 received a neobladder. We observed no significant difference in the DRS score in patients with a neobladder vs an ileal conduit at 6 or 18 months (b=-1.28, 95% CI -9.07-6.53, vs b=-1.55, 95% CI -12.48-9.38). However, informed decision making was negatively related to decision regret at 6 and 18 months (b=-13.08, 95% CI -17.05--9.11, and b=-8.54, 95% CI -4.26--2.63, respectively). Quality of life was negatively associated with decision regret at 18 months (b=-5.50, 95% CI -8.95--2.03). CONCLUSIONS: Patients treated with cystectomy who were more informed about bladder reconstruction options experienced less regret independent of the method selected. Efforts to inform and prepare patients for the bladder reconstruction decision may help prevent decision regret.
Subject(s)
Cystectomy , Decision Making , Urinary Bladder Neoplasms/surgery , Urinary Diversion/methods , Female , Humans , Longitudinal Studies , Male , Middle Aged , Neoplasm Invasiveness , Patient Reported Outcome Measures , Patient Satisfaction , Quality of Life , Urinary Bladder Neoplasms/pathologyABSTRACT
BACKGROUND: Relatively little is known about factors associated with long-term survival (LTS) following a diagnosis of ovarian cancer. METHODS: We conducted a retrospective study of high-grade serous ovarian cancer (HGSOC) to explore predictors of LTS (defined as ≥7 years of survival) using electronic medical record data from a network of integrated health care systems. Multivariable logistic regression with forward selection was used to compare characteristics of women who survived ≥7 years after diagnosis (n = 148) to those who died within 7 years of diagnosis (n = 494). RESULTS: Our final model included study site, age, stage at diagnosis, CA-125, comorbidity score, receipt of chemotherapy, BMI, and four separate comorbid conditions: weight loss, depression, hypothyroidism, and liver disease. Of these, only younger age, lower stage, and depression were statistically significantly associated with LTS. CONCLUSIONS: We did not identify any new characteristics associated with HGSOC survival. IMPACT: Prognosis of ovarian cancer generally remains poor. Large, pooled studies of ovarian cancer are needed to identify characteristics that may improve survival.
Subject(s)
Cancer Survivors/statistics & numerical data , Cystadenocarcinoma, Serous/mortality , Ovarian Neoplasms/mortality , Adolescent , Adult , Age Factors , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , California/epidemiology , Colorado/epidemiology , Comorbidity , Cystadenocarcinoma, Serous/drug therapy , Cystadenocarcinoma, Serous/pathology , Female , Follow-Up Studies , Humans , Middle Aged , Neoplasm Grading , Neoplasm Staging , Ovarian Neoplasms/drug therapy , Ovarian Neoplasms/pathology , Prognosis , Retrospective Studies , Survival Rate , Washington/epidemiology , Young AdultABSTRACT
PURPOSE: Patient centered care aims to align treatment with patient goals, especially when treatment options have equivalent clinical outcomes. For surgeries with lasting impacts that alignment is critical. To our knowledge no psychometrically tested preference elicitation measures exist to support patients with bladder cancer treated with cystectomy, who can often choose between ileal conduit and neobladder diversions. In this study we created a scale to measure how patient goals align with each type of urinary diversion and the associated surgical outcomes. MATERIALS AND METHODS: We performed formative research through focus groups and clinician outreach to adapt a goal dissonance measure. We mailed a survey to adult Kaiser Permanente® members who underwent cystectomy for bladder cancer between January 2013 and June 2015. Eligible patients were identified through electronic health records and chart review. Surveys were mailed 5 to 7 months postoperatively. We administered our 10-item decision dissonance scale along with other decision making measures. We explored goal alignment as well as dissonance. Psychometric analysis included factor analysis, evaluation of scale scores between surgery groups and evaluation with other decision making scores. RESULTS: We identified 10 goals associated with ileal conduit or neobladder diversion. Using survey data on 215 patients our scale differentiated patient goals associated with each diversion choice. On average patients with a neobladder strongly valued neobladder aligned goals such as maintaining body integrity and volitional voiding through the urethra. Patients with an ileal conduit had neutral values on average across all goals. CONCLUSIONS: Our measure lays the foundation for a simple value elicitation approach which could facilitate shared decision making about urinary diversion choice.
Subject(s)
Clinical Decision-Making/methods , Decision Making , Patient Preference , Urinary Bladder Neoplasms/surgery , Urinary Diversion/psychology , Aged , Cystectomy/adverse effects , Female , Focus Groups , Goals , Humans , Male , Middle Aged , Psychometrics , Surveys and Questionnaires , Urinary Diversion/adverse effects , Urinary Diversion/methodsABSTRACT
OBJECTIVE: To assess the relative contributions of patient and surgeon factors for predicting selection of ileal conduit (IC), neobladder (NB), or continent pouch (CP) urinary diversions (UD) for patients diagnosed with muscle-invasive/high-risk nonmuscle invasive bladder cancer. This information is needed to enhance research comparing cancer survivors' outcomes across different surgical treatment options. METHODS: Bladder cancer patients' age ≥21 years with cystectomy/UD performed from January 2010 to June 2015 in 3 Kaiser Permanente regions were included. All patient and surgeon data were obtained from electronic health records. A mixed effects logistic regression model was used treating surgeon as a random effect and region as a fixed effect. RESULTS: Of 991 eligible patients, 794 (80%) received IC. One hundred sixty-nine surgeons performed the surgeries and accounted for a sizeable proportion of the variability in patient receipt of UD (intraclass correlation coefficientâ¯=â¯0.26). The multilevel model with only patient factors showed good fit (area under the curveâ¯=â¯0.93, Hosmer-Lemeshow test Pâ¯=â¯.44), and older age, female sex, estimated glomerular filtration rate <45, 4+ comorbidity index score, and stage III/IV tumors were associated with higher odds of receiving an IC vs neobladder/continent pouch. However, including surgeon factors (annual cystectomy volume, specialty training, clinical tenure) had no association (Pâ¯=â¯.29). CONCLUSION: In this community setting, patient factors were major predictors of UD received. Surgeons also played a substantial role, yet clinical training and experience were not major predictors. Surgeon factors such as beliefs about UD options and outcomes should be explored.