Stakeholder perceptions of using "opt-out" for tobacco use treatment in a cancer care setting: a qualitative evaluation of patients, providers, and desk staff.

BACKGROUND: Continued tobacco use in cancer patients increases the risk of cancer treatment failure and decreases survival. However, currently, most cancer patients do not receive evidence-based tobacco treatment. A recently proposed "opt-out" approach would automatically refer all cancer patients who use tobacco to tobacco treatment, but its acceptability to cancer patients and providers is unknown. We aimed to understand stakeholder beliefs, concerns, and receptivity to using the "opt-out" approach for tobacco treatment referrals in a cancer care setting. METHODS: Semi-structured interviews were conducted with oncology patients, providers, and desk staff. The sample size was determined when theoretical saturation was reached. Given the differences among participant roles, separate interview guides were developed. Transcripts were analyzed using standard coding techniques for qualitative data using the Consolidated Framework for Implementation Research (CFIR) codebook. Emergent codes were added to the codebook to account for themes not represented by a CFIR domain. Coded transcripts were then entered into the qualitative analysis software NVivo to generate code reports for CFIR domains and emergent codes for each stakeholder group. Data were presented by stakeholder group and subcategorized by CFIR domains and emergent codes when appropriate. RESULTS: A total of 21 providers, 19 patients, and 6 desk staff were interviewed. Overall acceptance of the "opt out" approach was high among all groups. Providers overwhelmingly approved of the approach as it requires little effort from them to operate and saves clinical time. Desk staff supported the opt-out system and believed there are clinical benefits to patients receiving information about tobacco treatment. Many patients expressed support for using an opt-out approach as many smokers need assistance but may not directly ask for it. Patients also thought that providers emphasizing the benefits of stopping tobacco use to cancer treatment and survival would be an important factor motivating them to attend treatment. CONCLUSIONS: While providers appreciated that the system required little effort on their part, patients clearly indicated that promotion of tobacco cessation treatment by their provider would be vital to enhance willingness to engage with treatment. Future implementation efforts of opt-out systems will require implementation strategies that promote provider engagement with their patients around smoking cessation while continuing to limit burden on providers.

Hearing and Heeding the Voices of those With Advanced Illnesses.

OBJECTIVES: To describe the feasibility of a chaplain-led spiritually focused life review interview and the development of a spiritual legacy document (SLD) for patients with advanced diseases and to describe changes in spiritual well-being (SWB), spiritual coping strategies (SC), and quality of life (QOL) after receiving the SLD. PATIENTS AND METHODS: In all, 130 patients and support person (SP) pairs were recruited from July 2012 to January 2019. Following enrollment, demographic information was gathered and baseline questionnaires were administered. Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12) and a linear analog scale assessment (LASA) measured SWB. LASAs also measured QOL and emotional well-being (EWB). Positive Religious Coping Scale (RCOPE) measured SC. After completion of baseline forms, participants were interviewed (individually) by a chaplain. Interviews were digitally recorded, transcribed, and verified. Transcripts were edited and participants were given the opportunity to make adaptations. The participant-approved draft was then developed into a professionally printed SLD. Follow-up questionnaires were administered to assess change. RESULTS: Significant improvements from baseline to post-SLD follow-up were found for patients on the LASAs: SWB (average 7.7-8.3, P = .01), QOL (average 6.7-7.3, P = .03), EWB (average 6.9-7.5, P = .01), and on the positive RCOPE (average 1.8-2.0, P = .007). Effect sizes were approximately 0.25. Considering any improvement, 61.0% improved their positive RCOPE score, 46.6% improved EWB, and 39.7% improved SWB. No significant changes were found on the FACIT-Sp-12. No significant changes were found for SPs. CONCLUSION: The results suggest that the primary participants who completed the study benefited by significantly increasing their QOL, SWB, EWB, and SC.

Should Researchers Offer Results to Family Members of Cancer Biobank Participants? A Mixed-Methods Study of Proband and Family Preferences.

BACKGROUND: Genomic analysis may reveal both primary and secondary findings with direct relevance to the health of probands' biological relatives. Researchers question their obligations to return findings not only to participants but also to family members. Given the social value of privacy protection, should researchers offer a proband's results to family members, including after the proband's death? METHODS: Preferences were elicited using interviews and a survey. Respondents included probands from two pancreatic cancer research resources, plus biological and nonbiological family members. Hypothetical scenarios based on actual research findings from the two cancer research resources were presented; participants were asked return of results preferences and justifications. Interview transcripts were coded and analyzed; survey data were analyzed descriptively. RESULTS: Fifty-one individuals (17 probands, 21 biological relatives, 13 spouses/partners) were interviewed. Subsequently, a mailed survey was returned by 464 probands, 1,040 biological family members, and 399 spouses/partners. This analysis highlights the interviews, augmented by survey findings. Probands and family members attribute great predictive power and lifesaving potential to genomic information. A majority hold that a proband's genomic results relevant to family members' health ought to be offered. While informants endorse each individual's choice whether to learn results, most express a strong moral responsibility to know and to share, particularly with the younger generation. Most have few concerns about sharing genetic information within the family; rather, their concerns focus on the health consequences of not sharing. CONCLUSIONS: Although additional studies in diverse populations are needed, policies governing return of genomic results should consider how families understand genomic data, how they value confidentiality within the family, and whether they endorse an ethics of sharing. A focus on respect for individual privacy-without attention to how the broad social and cultural context shapes preferences within families-cannot be the sole foundation of policy.

Comparative Assessment of Patient Preferences and Tolerability in Barrett Esophagus Screening: Results From a Randomized Trial.

GOALS: To determine patient preference for the Barrett esophagus (BE) screening techniques. BACKGROUND: Sedated esophagogastroduodenoscopy (sEGD) and unsedated transnasal endoscopy (uTNE) are both potential techniques for BE screening. However, systematic assessment of patient preference for these 2 techniques is lacking. As part of a comparative effectiveness randomized trial of BE screening modalities, we measured short-term patient preferences for the following approaches: in-clinic uTNE (huTNE), mobile-based uTNE (muTNE), and sEGD using a novel assessment instrument. STUDY: Consenting community patients without known BE were randomly assigned to receive huTNE, muTNE, or sEGD, followed by a telephone administered preference and tolerability assessment instrument 24 hours after study procedures. Patient preference was measured by the waiting trade-off method. RESULTS: In total, 201 patients completed screening with huTNE (n=71), muTNE (n=71), or sEGD (n=59), and a telephone interview. Patients' preferences for sEGD and uTNE using the waiting trade-off method were comparable (P=0.51). Although tolerability scores were superior for sEGD (P<0.001) compared with uTNE, scores for uTNE examinations were acceptable. CONCLUSIONS: Patient preference is comparable between sEGD and uTNE for diagnostic examinations conducted in an endoscopy suite or in a mobile setting. Given acceptable tolerability, uTNE may be a viable alternative to sEGD for BE screening.

I'm Still Me: Inspiration and Instruction from Individuals with Brain Cancer.

Individuals with brain cancer face many challenges, including threats to cognition, personality, and sensory and motor functioning. These can alter one's sense of identity and result in despair. Chaplain-led spiritual interviews were conducted with 19 patients with brain cancer as part of a larger spiritual legacy intervention called "Hear My Voice." The majority was female (58%), married (68%) and had aggressive/advanced tumors (63%). Participants were 22-68 years of age and expressed the following religious affiliations: Protestant (42%), Catholic (21%), Muslim (5%), and none (32%). Framework analysis was applied to reduce and understand the interview data. Primary codes were relationships with: God or the spiritual, others, and self. Brain cancer was reported to deepen and enrich patients' commitment to these relationships. Struggle and grief were also revealed. Results suggest the continued vitality, growth and generativity of these participants and provide insight for chaplains and others on the medical team.

Development and validation of the Patient Experience with Treatment and Self-management (PETS): a patient-reported measure of treatment burden.

PURPOSE: The purpose of this study was to develop and validate a new comprehensive patient-reported measure of treatment burden-the Patient Experience with Treatment and Self-management (PETS). METHODS: A conceptual framework was used to derive the PETS with items reviewed and cognitively tested with patients. A survey battery, including a pilot version of the PETS, was mailed to 838 multi-morbid patients from two healthcare institutions for validation. RESULTS: A total of 332 multi-morbid patients returned completed surveys. Diagnostics supported deletion and consolidation of some items and domains. Confirmatory factor analysis supported a domain model for scaling comprised of 9 factors: medical information, medications, medical appointments, monitoring health, interpersonal challenges, medical/healthcare expenses, difficulty with healthcare services, role/social activity limitations, and physical/mental exhaustion. Scales showed good internal consistency (α range 0.79-0.95). Higher PETS scores, indicative of greater treatment burden, were correlated with more distress, less satisfaction with medications, lower self-efficacy, worse physical and mental health, and lower convenience of healthcare (Ps < 0.001). Patients with lower health literacy, less adherence to medications, and more financial difficulties reported higher PETS scores (Ps < 0.01). CONCLUSION: A comprehensive patient-reported measure of treatment burden can help to better characterize the impact of treatment and self-management burden on patient well-being and guide care toward minimally disruptive medicine.

Building a measurement framework of burden of treatment in complex patients with chronic conditions: a qualitative study.

BACKGROUND: Burden of treatment refers to the workload of health care as well as its impact on patient functioning and well-being. We set out to build a conceptual framework of issues descriptive of burden of treatment from the perspective of the complex patient, as a first step in the development of a new patient-reported measure. METHODS: We conducted semistructured interviews with patients seeking medication therapy management services at a large, academic medical center. All patients had a complex regimen of self-care (including polypharmacy), and were coping with one or more chronic health conditions. We used framework analysis to identify and code themes and subthemes. A conceptual framework of burden of treatment was outlined from emergent themes and subthemes. RESULTS: Thirty-two patients (20 female, 12 male, age 26-85 years) were interviewed. Three broad themes of burden of treatment emerged including: the work patients must do to care for their health; problem-focused strategies and tools to facilitate the work of self-care; and factors that exacerbate the burden felt. The latter theme encompasses six subthemes including challenges with taking medication, emotional problems with others, role and activity limitations, financial challenges, confusion about medical information, and health care delivery obstacles. CONCLUSION: We identified several key domains and issues of burden of treatment amenable to future measurement and organized them into a conceptual framework. Further development work on this conceptual framework will inform the derivation of a patient-reported measure of burden of treatment.

The effects of incremental costs of smoking and obesity on health care costs among adults: a 7-year longitudinal study.

OBJECTIVE: To provide the simultaneous 7-year estimates of incremental costs of smoking and obesity among employees and dependents in a large health care system. METHODS: We used a retrospective cohort aged 18 years or older with continuous enrollment during the study period. Longitudinal multivariate cost analyses were performed using generalized estimating equations with demographic adjustments. RESULTS: The annual incremental mean costs of smoking by age group ranged from $1274 to $1401. The incremental costs of morbid obesity II by age group ranged from $5467 to $5530. These incremental costs drop substantially when comorbidities are included. CONCLUSIONS: Obesity and smoking have large long-term impacts on health care costs of working-age adults. Controlling comorbidities impacted incremental costs of obesity but may lead to underestimation of the true incremental costs because obesity is a risk factor for developing chronic conditions.

Who is counseled to lose weight? Survey results and anthropometric data from 3,149 lower socioeconomic women.

Because obesity is a grave public health concern, this study examined the percentage of disadvantaged women who recalled ever having received weight loss advice from a healthcare provider and factors associated with such advice. This study was part of a 5-clinic, cervical cancer prevention trial. Patients not immediately post-partum completed a Spanish/English survey; height and weight were also obtained. Of the 3,149 respondents (response rate 83%), 2,138 (68%) were overweight or obese (body mass index (BMI) ≥ 25); 94% reported a household income of <$35,000/year; 69% were Hispanic; 10% non-Hispanic black; and 40% completed the survey in Spanish. Only one-third reported ever having been told to lose weight. Based on BMI, these rates were 15% in the 25-29.9 range (overweight); 34% within 30-34.9; 57% within 35-39.9; and 73% ≥ 40. In univariate analyses, among overweight women, diabetes or English-speaking was associated with weight loss advice. In multivariate analyses, being older, more educated, and diabetic were associated with such advice. 48% of non-Hispanic whites, 31% of non-Hispanic blacks, and 29% of Hispanic had a home scale. Among disadvantaged women, obesity alone does not determine who recalls weight loss advice. Language barriers and lack of a home scale merit further study to address obesity.

Cost modeling of preoperative axillary ultrasound and fine-needle aspiration to guide surgery for invasive breast cancer.

PURPOSE: Preoperative axillary lymph node ultrasound (US) and fine-needle aspiration (FNA) biopsy can identify a proportion of node-positive patients and avoid sentinel lymph node (SLN) surgery and direct surgical treatment. We compared the costs with preoperative US/FNA to without US/FNA (standard of care) for invasive breast cancer. METHODS: Using decision-analytic software we constructed a model to assess the costs associated with the two preoperative strategies. Diagnostic test sensitivities and specificities were obtained from literature review. Costs were derived from Medicare payment rates and actual resource utilization. Base-case results were fully probabilistic to capture parameter uncertainty in economic results. RESULTS: Base-case results estimate total mean costs per patient of $10,947 ("$" indicates US dollars throughout) with the US/FNA strategy and $10,983 with standard of care, an incremental cost savings of $36, on average, per patient [95% confidence interval (CI) of cost difference: -$248 to $179]. Most (63%) of the simulations resulted in cost saving with axillary US/FNA. One-way sensitivity analyses suggest that results are sensitive to assumed diagnostic and surgical costs and selected diagnostic test parameters. US/FNA approach was similar in costs or cost saving relative to the standard of care for all tumor stages. CONCLUSIONS: The additional cost of performing axillary US with possible FNA in every patient is balanced, on average, by the savings from avoiding SLN in cases where metastasis can be documented preoperatively. Routine use of preoperative axillary US with FNA to guide surgical planning can decrease the overall cost of patient care for invasive breast cancer.