What do patients want to know about surgery for low-risk thyroid cancer? A qualitative study.

BACKGROUND: Shared decision-making about treatment for low-risk thyroid cancer requires patients and surgeons to work together to select treatment that best balances risks and expected outcomes with patient preferences and values. To participate, patients must be activated and ask questions. We aimed to characterize what topics patients prioritize during treatment decision-making. METHODS: We identified substantive questions by patients with low-risk (cT1-2, N0) thyroid cancer during audio-recorded consultations with 9 surgeons at 2 unique health care systems. Logistics questions were excluded. Qualitative content analysis was used to identify major themes among patients' questions and surgeon responses. RESULTS: Overall, 28 of 30 patients asked 253 substantive questions, with 2 patients not asking any substantive questions (median 8, range 0-25). Patients were 20 to 71 years old, mostly White (86.7%) and female (80.0%). The questions addressed extent of surgery, hormone supplementation, risk of cancer progression, radioactive iodine, and etiology of thyroid cancer. When patients probed for a recommendation regarding extent of surgery, surgeons often responded indirectly. When patients asked how surgery could impact quality of life, surgeons focused on oncologic benefits and surgical risk. Patients commonly asked about hormone supplementation and radioactive iodine. CONCLUSION: Patient questions focused on the decision regarding extent of surgery, quality of life, and nonsurgical aspects of thyroid cancer care. Surgeon responses do not consistently directly answer patients' questions but focus on the risks, benefits, and conduct of surgery itself. These findings suggest an opportunity to help surgeons with resources to improve shared decision-making by providing information that patients prioritize.

Deficiencies in postoperative surveillance for veterans with gastrointestinal cancer.

BACKGROUND AND OBJECTIVES: National guidelines for gastrointestinal (GI) cancers offer surveillance algorithms to facilitate detection of recurrent disease, yet adherence rates are unknown. We sought to characterize postoperative surveillance patterns for veterans with GI cancer at a tertiary care Veterans Affairs Hospital. METHODS: A single-center retrospective cohort study identified patients who underwent surgical resection for colorectal, gastroesophageal or hepatopancreaticobiliary malignancy from 2010-2016. We calculated the annual rate of cancer-directed clinic visits and abdominal imaging and used National Comprehensive Cancer Network guidelines as a benchmark by which to assess adequate surveillance. RESULTS: Ninety-seven patients met inclusion criteria. Median surveillance time was 1203 days. Overall, 44% of patients had insufficient surveillance. Specifically, 11% received no postoperative imaging and 7% had no cancer-directed clinic visits. An additional 30% received less than recommended surveillance imaging and 12% attended fewer than recommended clinic visits. By disease site, insufficient imaging was most common for patients with hepatopancreaticobiliary cancer (63%), while inadequate clinic follow-up was highest for colorectal cancer (24%). CONCLUSION: A significant proportion of veterans with GI cancer received either inadequate postoperative surveillance based on national guidelines. This deficiency represents an opportunity for improvement through targeted efforts, including telemedicine and education of patients and providers.

A logic model for precision medicine implementation informed by stakeholder views and implementation science.

PURPOSE: Precision medicine promises to improve patient outcomes, but much is unknown about its adoption within health-care systems. A comprehensive implementation plan is needed to realize its benefits. METHODS: We convened 80 stakeholders for agenda setting to inform precision medicine policy, delivery, and research. Conference proceedings were audio-recorded, transcribed, and thematically analyzed. We mapped themes representing opportunities, challenges, and implementation strategies to a logic model, and two implementation science frameworks provided context. RESULTS: The logic model components included inputs: precision medicine infrastructure (clinical, research, and information technology), big data (from data sources to analytics), and resources (e.g., workforce and funding); activities: precision medicine research, practice, and education; outputs: precision medicine diagnosis; outcomes: personal utility, clinical utility, and health-care utilization; and impacts: precision medicine value, equity and access, and economic indicators. Precision medicine implementation challenges include evidence gaps demonstrating precision medicine utility, an unprepared workforce, the need to improve precision medicine access and reduce variation, and uncertain impacts on health-care utilization. Opportunities include integrated health-care systems, partnerships, and data analytics to support clinical decisions. Examples of implementation strategies to promote precision medicine are: changing record systems, data warehousing techniques, centralized technical assistance, and engaging consumers. CONCLUSION: We developed a theory-based, context-specific logic model that can be used by health-care organizations to facilitate precision medicine implementation.

Veterans Affairs Primary Care Provider Perceptions of Insomnia Treatment.

STUDY OBJECTIVES: Insomnia is a widespread issue among United States adults and rates of insomnia among veterans are even higher than the general population. Prior research examining primary care provider (PCP) perspectives on insomnia treatment found that: sleep hygiene and pharmacotherapy are the primary treatments offered; PCPs tend to focus on perceived causes of insomnia rather than the insomnia itself; and neither patients nor providers are satisfied with insomnia treatment options. Although insomnia complaints are typically first reported to primary care providers, little research has focused on perspectives regarding insomnia treatment among PCPs working in the largest integrated health care system in the United States-the Veterans Affairs (VA) health care system. This study was conducted to examine VA PCP perceptions of the availability of insomnia treatments, identify specific strategies offered by PCPs, and examine perceptions regarding the importance of treating insomnia and the role of comorbid conditions. METHODS: A survey was conducted within the VA health care system. Primary care providers completed surveys electronically. RESULTS: A high percentage of veterans (modal response = 20% to 39%) seen in VA primary care settings report an insomnia complaint to their provider. Almost half of respondents do not consistently document insomnia in the medical record (46% endorsed "sometimes," "rarely," or "never"). PCPs routinely advise sleep hygiene recommendations for insomnia (ie, avoid stimulants before bedtime [84.3%], and keep the bedroom environment quiet and dark and comfortable [68.6%]) and many are uncertain if cognitive behavioral therapy for insomnia is available at their facility (43.1%). CONCLUSIONS: Findings point to the need for systems-level changes within health care systems, including the adoption of evidence-based clinical practice standards for insomnia and PCP education about the processes that maintain insomnia. COMMENTARY: A commentary on this article appears in this issue on page 937.

Patient factors associated with initiation of behavioral weight loss treatment: a prospective observational study in an integrated care setting.

Low enrollment in behavioral weight loss treatments limits their impact. We aimed to identify factors associated with treatment initiation. The participants were outpatients (n = 198) at Veterans Affairs (VA) healthcare facilities who were referred to a free VA-based behavioral weight loss treatment. Participants were assessed on psychosocial factors potentially relevant to treatment initiation. Subsequent treatment initiation was determined via medical record review. Study participants were 77 % male, 60 % African American, and 54 % initiated treatment. In multivariable analyses, treatment initiation was associated with being single, higher anxiety, and patients' perceptions that referring provider supported their weight autonomy. Endorsement of treatment barriers was not associated with treatment initiation. Treatments offering in-person sessions and mood management components were rated as more preferred. Initiation of behavioral weight loss treatments may increase if patients believe that providers respect their weight control autonomy and if healthcare organizations offer treatments that match patients' preferences.

Study design and protocol for a theory-based behavioral intervention focusing on maintenance of weight loss: the Maintenance After Initiation of Nutrition TrAINing (MAINTAIN) study.

BACKGROUND: Obesity is a significant public health problem. Although various lifestyle approaches are effective for inducing significant weight loss, few effective behavioral weight maintenance strategies have been identified. It has been proposed that behavior maintenance is a distinct state that involves different psychological processes and behavioral skills than initial behavior change. Previously, we created a conceptual model that distinguishes behavior initiation from maintenance. This model was used to generate Maintenance After Initiation of Nutrition TrAINing (MAINTAIN), an intervention to enhance weight loss maintenance following initiation. The effectiveness of MAINTAIN is being evaluated in an ongoing trial, the rationale and procedures of which are reported herein. METHODS/DESIGN: Veterans aged ≤ 75 with body mass index ≥ 30 kg/m(2) participate in a 16-week, group-based weight loss program. Participants who lose ≥ 4 kg by the end of 16 weeks (target n = 230) are randomized 1:1 to receive (a) usual care for 56 weeks or (b) MAINTAIN, a theoretically-informed weight loss maintenance intervention for 40 weeks, followed by 16 weeks of no intervention contact. MAINTAIN involves 3 in-person group visits that transition to 8 individualized telephone calls with decreasing contact frequency. MAINTAIN focuses on satisfaction with outcomes, weight self-monitoring, relapse prevention, and social support. We hypothesize that, compared to usual care, MAINTAIN will result in at least 3.5 kg less regain and better relative levels of caloric intake and physical activity over 56 weeks, and that it will be cost-effective. DISCUSSION: If effective, MAINTAIN could serve as a model for redesigning existing weight loss programs. CLINICALTRIALSGOV IDENTIFIER: NCT01357551.

Validation of a measure of family experience of patients with serious illness: the QUAL-E (Fam).

CONTEXT: Family members of seriously ill patients experience significant burden as they advocate with providers and participate in key decisions for loved ones. Most assessments focus on patient experience, yet family members' own quality of experience is central to comprehensive care. OBJECTIVES: This study validated a measure of the quality of family experience, the QUAL-E (Fam), in palliative care. METHODS: We enrolled family members of terminally ill patients admitted to general medicine services at two hospitals. Items were based on foundational work originally done for the patient instrument, QUAL-E, and interviews of family members of terminally ill patients. Cognitive interviewing was used to refine items, which then underwent formal testing factor analysis. In the first sample, we assessed factor structure. A subsequent sample established predictive validity and test-retest reliability. RESULTS: The initial item pool was reduced to a four-domain, 35-item scale and administered to the validation sample. Further analyses produced a final brief scale comprising 17 items, demonstrating appropriate convergent and divergent validity. Test-retest reliability demonstrated expected levels of stability in a highly changeable population. The scale provides an assessment of family experience and includes subscales assessing relationship with health care provider and completion. Additional scale items assess symptom experience and issues of preparation. CONCLUSION: The QUAL-E (Fam) is a companion instrument to the patient QUAL-E measure of quality of life at the end of life and is part of a package of assessment tools that can help evaluate the entire patient experience and contribute to quality care.

Obesity-related health status changes and weight-loss treatment utilization.

BACKGROUND: Behavioral weight-loss treatment can improve health, yet it is underutilized. Factors leading to initiation of weight-loss treatment are not well characterized. In particular, it is unknown whether changes in obesity-related health status contribute to weight-loss treatment initiation. PURPOSE: To determine if recent weight change or diagnosis of an obesity-related comorbidity was associated with utilization of a behavioral weight-loss program in an integrated healthcare setting. METHODS: In a retrospective cohort study of 45,272 Veterans Affairs (VA) patients with BMI >30, logistic regression was used to examine whether recent weight change or obesity-related comorbidities newly diagnosed in the past 6 months were associated with initiation of a VA behavioral weight management program (called MOVE!) in 2010 or sustained MOVE! use (eight or more sessions). Weight change in prior year was categorized as >3% weight loss; weight stable (<3% change); or weight gain of 3%-4.9%, 5%-9.9%, or ≥10%. Data were analyzed in 2013. RESULTS: Patients were 91% male, 68% white, and had a mean age of 58 years. Patients were more likely to initiate treatment if they had ≥3% weight gain (3%-4.9%: OR=1.64, 95% CI=1.52, 1.77; 5%-9.9%: OR=1.99, 95% CI=1.84, 2.16; ≥10%: OR=2.68, 95% CI=2.32, 3.10) or were newly diagnosed with any obesity-related comorbidity (ORs: 2.14-3.59). Weight change and new comorbidity diagnoses were not associated, however, with sustained MOVE! use. CONCLUSIONS: Adverse obesity-related health events were associated with initiation of behavioral weight-loss treatment offered in an integrated healthcare setting.

Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) - a randomized, controlled trial.

BACKGROUND: Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans. METHODS: Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support.The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C. DISCUSSION: Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes. TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT00321789.

Validation of a questionnaire to assess self-reported colorectal cancer screening status using face-to-face administration.

PURPOSE: The aim of this study was to assess the accuracy of a National Cancer Institute (NCI)-developed colorectal cancer screening questionnaire. METHODS: We conducted 36 cognitive interviews and made iterative changes to the questionnaire to improve comprehension. The revised questionnaire was administered face-to-face to 201 participants. The primary outcome was agreement between questionnaire responses and medical records for whether or not a participant was up-to-date for any colorectal cancer screening test. RESULTS: Comprehension of descriptions and questions was generally good; however, the barium enema description required several revisions. The sensitivity of the questionnaire for up-to-date screening status was 94%, specificity 63%, and concordance 88%. CONCLUSIONS: The modified questionnaire was highly sensitive for determining if a person was up-to-date for any colorectal cancer screening test, although the specificity was low. Given the difficulty of obtaining all relevant records, self-report using this questionnaire is a reasonable option for identifying people who have undergone testing.

"Are you at peace?": one item to probe spiritual concerns at the end of life.

BACKGROUND: Physicians may question their role in probing patients' spiritual distress and the practicality of addressing such issues in the time-limited clinical encounter. Yet, patients' spirituality often influences treatment choices during a course of serious illness. A practical, evidence-based approach to discussing spiritual concerns in a scope suitable to a physician-patient relationship may improve the quality of the clinical encounter. METHODS: Analysis of the construct of being "at peace" using a sample of patients with advanced cancer, congestive heart failure, or chronic obstructive pulmonary disease. Descriptive statistics were used to compare response distributions among patient subgroups. Construct validity of the concept of being "at peace" was evaluated by examining Spearman rank correlations between the item and existing spirituality and quality-of-life subscales. RESULTS: Variation in patient responses was not explained by demographic categories or diagnosis, indicating broad applicability across patients. Construct validity showed that feeling at peace was strongly correlated with emotional and spiritual well-being. It was equally correlated with faith and purpose subscales, indicating applicability to traditional and nontraditional definitions of spirituality. CONCLUSIONS: Asking patients about the extent to which they are at peace offers a brief gateway to assessing spiritual concerns. Although these issues may be heightened at the end of life, research suggests they influence medical decision making throughout a lifetime of care.