First-Line Selpercatinib or Chemotherapy and Pembrolizumab in RET Fusion-Positive NSCLC.

BACKGROUND: Selpercatinib, a highly selective potent and brain-penetrant RET inhibitor, was shown to have efficacy in patients with advanced RET fusion-positive non-small-cell lung cancer (NSCLC) in a nonrandomized phase 1-2 study. METHODS: In a randomized phase 3 trial, we evaluated the efficacy and safety of first-line selpercatinib as compared with control treatment that consisted of platinum-based chemotherapy with or without pembrolizumab at the investigator's discretion. The primary end point was progression-free survival assessed by blinded independent central review in both the intention-to-treat-pembrolizumab population (i.e., patients whose physicians had planned to treat them with pembrolizumab in the event that they were assigned to the control group) and the overall intention-to-treat population. Crossover from the control group to the selpercatinib group was allowed if disease progression as assessed by blinded independent central review occurred during receipt of control treatment. RESULTS: In total, 212 patients underwent randomization in the intention-to-treat-pembrolizumab population. At the time of the preplanned interim efficacy analysis, median progression-free survival was 24.8 months (95% confidence interval [CI], 16.9 to not estimable) with selpercatinib and 11.2 months (95% CI, 8.8 to 16.8) with control treatment (hazard ratio for progression or death, 0.46; 95% CI, 0.31 to 0.70; P<0.001). The percentage of patients with an objective response was 84% (95% CI, 76 to 90) with selpercatinib and 65% (95% CI, 54 to 75) with control treatment. The cause-specific hazard ratio for the time to progression affecting the central nervous system was 0.28 (95% CI, 0.12 to 0.68). Efficacy results in the overall intention-to-treat population (261 patients) were similar to those in the intention-to-treat-pembrolizumab population. The adverse events that occurred with selpercatinib and control treatment were consistent with those previously reported. CONCLUSIONS: Treatment with selpercatinib led to significantly longer progression-free survival than platinum-based chemotherapy with or without pembrolizumab among patients with advanced RET fusion-positive NSCLC. (Funded by Eli Lilly and others; ClinicalTrials.gov number, NCT04194944.).

Association of race/ethnicity and patient care experiences with receipt of definitive treatment among prostate cancer survivors: a SEER-CAHPS study.

PURPOSE: This study aimed to evaluate the association of race/ethnicity, patient care experiences (PCEs), and receipt of definitive treatment and treatment modality among older adults in the United States (US) with localized prostate cancer (PCa). METHODS: Using Surveillance, Epidemiology and End Results dataset linked to Medicare Consumer Assessment of Healthcare Providers and Systems (SEER-CAHPS) for 2007-2015, we identified men aged ≥ 65 years who completed a CAHPS survey within one year before and one year after PCa diagnosis. Associations of race/ethnicity (non-Hispanic White (NHW), non-Hispanic Black (NHB), Hispanic, non-Hispanic Asian (NHA), and other) and of interactions between race/ethnicity and PCEs (getting needed care, getting care quickly, doctor communication, and care coordination) with the receipt of definitive PCa treatment and treatment modality within 3 and 6 months of diagnosis were examined using logistic regressions. RESULTS: Among 1,438 PCa survivors, no racial/ethnic disparities in the receipt of definitive treatment were identified. However, NHB patients were less likely to receive surgery (vs. radiation) within 3 and 6 months of PCa diagnosis than NHW patients (OR 0.397, p = 0.006 and OR 0.419, p = 0.005), respectively. Among NHA patients, a 1-point higher score for getting care quickly was associated with lower odds (OR 0.981, p = 0.043) of receiving definitive treatment within 3 months of PCa diagnosis, whereas among NHB patients, a 1-point higher score for doctor communication was associated with higher odds (OR 1.023, p = 0.039) of receiving definitive treatment within 6 months of PCa diagnosis. DISCUSSION: We observed differential associations between PCEs and receipt of definitive treatment based on patient race/ethnicity. Further research is needed to explore these associations.

Changes in Arkansans' attitudes toward pharmacist involvement and regulation of medical cannabis following its availability in Arkansas.

BACKGROUND: Pharmacists are likely to encounter questions from patients regarding medical cannabis (MC). This serves as an opportunity for pharmacists to provide reliable medical information about MC dosing, drug interactions, and impact on preexisting health conditions. OBJECTIVES: This study examined changes in perceptions of the Arkansan community toward MC regulation and pharmacist involvement in MC dispensing after MC products became available in Arkansas. METHODS: A longitudinal, self-administered online survey was conducted in February 2018 (baseline) and September 2019 (follow-up). Baseline participants were recruited through Facebook posts, emails, and printed flyers. Participants from the baseline survey (N = 1526) were invited to participate in the follow-up survey. Paired t tests were used to determine changes in responses, and multivariable regression analysis was used to identify factors associated with follow-up perceptions. RESULTS: Participants (n = 607, response rate 39.8%) started the follow-up survey, resulting in 555 usable surveys. The largest group of participants was 40-64 year old (40.9%). The majority were female (67.9%), white (90.6%), and reported past 30-day cannabis use (83.1%). Compared to baseline, participants preferred less regulatory control of MC. They were also less likely to agree that pharmacists helped improve MC-related patient safety. Participants favoring less MC regulation were more likely to report 30-day cannabis use and perceived cannabis to have low health risk. Past 30-day cannabis use was also significantly associated with disagreement that pharmacists improve patient safety and are well-trained to provide MC counseling. CONCLUSION: After MC product availability, Arkansans' attitudes changed toward less MC regulation and less agreement with the pharmacist's role in improving MC safety. These findings call for pharmacists to better promote their role in public health safety and demonstrate their knowledge concerning MC. Pharmacists should advocate for an expanded, active consultant role in dispensaries to improve safety of MC use.

Improving quality of life assessments for high-need adult Medicaid service users with mental health conditions.

PURPOSE: There is a lack of consensus on how to evaluate health and social service programs for people with mental health (MH) conditions. Having service users be the primary decision makers in selecting outcome measures can inform a meaningful evaluation strategy. We sought to identify the quality of life (QoL) survey preferences of high-need adult service users with MH conditions. METHODS: A systematic review identified generic, self-reported QoL surveys with evidence of validity in MH populations of interest. An advisory panel selected the most promising surveys to assess the success of programs like Medicaid for MH service users. Three groups of high-need, adult service users with MH conditions and one group of direct care staff ranked the surveys from the advisory panel, and generated and ranked characteristics that were desirable or undesirable in a QoL survey. RESULTS: Twenty-two surveys met the inclusion criteria. Of the six surveys selected by the advisory panel, groups of service users and direct care staff most preferred the Warwick-Edinburg Mental Well-being Scale (WEMWBS). The WEMWBS best embodied the features prioritized by the groups: to have a user-friendly format and positive focus, to be clearly worded and brief, and to avoid presumptive or unrealistic items. Service user groups appreciated survey topics most amenable to self-report, such as satisfaction with relationships. CONCLUSION: Using QoL surveys that service users prefer can reduce the chance that deteriorating QoL is going unchecked, and increase the chance that decisions based on survey findings are meaningful to service users.

Using a Facebook group to facilitate faculty-student interactions during preclinical medical education: a retrospective survey analysis.

BACKGROUND: Strong learner-teacher relationships are associated with more successful learning outcomes. With shortened modular curricula and increased availability of online resources, fostering faculty interaction with preclinical medical students has become more challenging. We sought to enhance learner-teacher relationships by engaging in discussion with preclinical medical students in their own online space. METHODS: We utilized a closed Facebook discussion group, where faculty and students voluntarily joined in informal discussions and shared announcements related to their courses. The closed discussion group allowed only participating students and faculty to see others' posts within the group. This provided a platform to freely interact within the confines of the group while maintaining privacy for the personal Facebook accounts of both faculty and students. We utilized the discussion group through three separate organ system-based modules for 14 weeks. Afterward, students were asked to complete an anonymous, voluntary online survey about their experience. RESULTS: 94.1% (160/170) of enrolled second-year medical students joined the voluntary FB discussion group. There were 214 posts, 628 comments, and 4166 reactions in this discussion group during the three modules. Of the students in the group, 74.4% (119/160) responded to the online survey. Overall, students strongly agreed that the Facebook discussion group fostered better rapport with faculty, helped content learning, and improved emotional well-being. Also, they felt more comfortable seeking academic help after using the discussion group. They reported a slight preference for Facebook over email as a medium for asking questions, but no preference for either as a medium for distributing announcements. Students overwhelmingly recommended that the discussion group should be continued in future years. CONCLUSION: The Facebook discussion group was a free, efficient, and effective method of cultivating the learner-teacher relationship with the preclinical medical students, resulting in reported enhancement of learning and morale.

Arkansas community's attitudes toward the regulation of medical cannabis and the pharmacist's involvement in Arkansas medical cannabis.

OBJECTIVES: This study explored the attitudes of the Arkansas community toward medical cannabis (MC) regulation and the role of pharmacists in dispensing MC before the product became available and examined whether participants' demographics (e.g., age, gender) and characteristics (e.g., history of cannabis use) were associated with these attitudes. DESIGN: Cross-sectional survey. SETTING AND PARTICIPANTS: Using social media, a university research registry, and posted flyers, we invited residents of Arkansas to participate in the self-administered online survey study during a 3-month period, February to April, in 2018. OUTCOME MEASURES: Five questions that inquired about participants' attitudes toward MC regulation and pharmacists' roles regarding MC use. RESULTS: Participants (n = 1343) who completed at least 1 of the 5 questions were included. The majority were aged 40-64 years (52.2%), female (69.1%), and white (88.7%). Most participants reported a history of cannabis use (81.8%) and possession or intention to apply for an MC card (52.9%). Among the conditions approved for MC use, pain (20.3%), arthritis (15.4%), and posttraumatic stress disorder (14.5%) were reported frequently. Likewise, prescription use for mood disorders (46.1%) and pain (37.4%) were also reported. In multivariable regression analyses, participants' history of cannabis use was associated with a preference for lesser oversight of MC, disagreement with MC being available through a pharmacy only, and disagreement on whether MC should be regulated before it is legalized for recreational use (all P < 0.001). It was also associated with a decrease in agreement that pharmacists are well-trained to improve patient safety (P < 0.001) and counsel patients regarding appropriate MC use (P = 0.032). CONCLUSION: Participants who had previously used cannabis were in favor of fewer restrictions and negatively perceived pharmacists' involvement in ensuring appropriate dispensing and MC use. The findings may highlight the need for Arkansas pharmacists to explore alternative ways to promote the safe and proper MC use.

Validation of Newly Developed Surveys to Evaluate Patients' and Providers' Satisfaction with Telehealth Obstetric Services.

Background: Patient and/or provider satisfaction and experience are among the most important indicators for quality assurance of health care services, including telehealth. Validated surveys should be used for this purpose to provide reliable information for a program evaluation. Objective: To validate the newly developed satisfaction surveys, report patient, and provider satisfaction with Antenatal and Neonatal Guidelines, Education and Learning Systems (ANGELS) telehealth services. Methods: Two self-administered paper surveys were developed by a multidisciplinary team. The surveys were validated among obstetric patients who received telehealth services in 2016 and providers in Arkansas from July to August 2017. Psychometric testing was performed to establish reliability and validity of both the surveys. Descriptive statistics was performed to describe patient and provider satisfaction. Results: A total of 89 patient- and 66 provider surveys were analyzed. Construct validity and internal consistency reliability (Cronbach's α >0.7) were confirmed on both the surveys. The majority of patients were highly satisfied with telehealth services and reported positive perceptions toward future use of services. In the past 12 months, telehealth (78.6%) was the most used ANGELS service by providers. Finally, >90% of the providers reported high satisfaction and rated telehealth services as "excellent." Conclusions: The newly developed patient and provider telehealth surveys were reliable and valid. The surveys also demonstrated that the telehealth services were well-accepted and highly valued in a sample of obstetric patients and providers. As both surveys are short, they can be used in routine evaluation of patient and provider satisfaction with similar telehealth programs in the country.

Correction to: Do Insurance Mandates Affect Racial Disparities in Outcomes for Children with Autism?

The original version of this article unfortunately contained a mistake in the analysis of the Tables 4 and 5.

Cost-related Nonadherence to Medication Treatment Plans: Native Hawaiian and Pacific Islander National Health Interview Survey, 2014.

BACKGROUND: Adherence to medication treatment plans is important for chronic disease (CD) management. Cost-related nonadherence (CRN) puts patients at risk for complications. Native Hawaiians and Pacific Islanders (NHPI) suffer from high rates of CD and socioeconomic disparities that could increase CRN behaviors. OBJECTIVE: Examine factors related to CRN to medication treatment plans within an understudied population. RESEARCH DESIGN: Using 2014 NHPI-National Health Interview Survey data, we examined CRN among a nationally representative sample of NHPI adults. Bonferroni-adjusted Wald test and multivariable logistic regression were performed to examine associations among financial burden-related factors, CD status, and CRN. RESULTS: Across CD status, NHPI engaged in CRN behaviors had, on an average, increased levels of perceived financial stress, financial insecurity with health care, and food insecurity compared with adults in the total NHPI population. Regression analysis indicated perceived financial stress [adjusted odds ratio (AOR)=1.16; 95% confidence intervals (CI), 1.10-1.22], financial insecurity with health care (AOR=1.96; 95% CI, 1.32-2.90), and food insecurity (AOR=1.30; 95% CI, 1.06-1.61) all increase the odds of CRN among those with CD. We also found significant associations between perceived financial stress (AOR=1.15; 95% CI, 1.09-1.20), financial insecurity with health care (AOR=1.59; 95% CI, 1.19-2.12), and food insecurity (AOR=1.31; 95% CI, 1.04-1.65) and request for lower cost medication. CONCLUSIONS: This study demonstrated health-related and non-health-related financial burdens can influence CRN behaviors. It is important for health care providers to collect and use data about the social determinants of health to better inform their conversations about medication adherence and prevent CRN.

Assessment of Reliability and Validity of SF-12v2 among a Diabetic Population.

OBJECTIVES: To validate the Medical Outcomes Study Short Form version 2 (SF-12v2) in diabetic patients. METHODS: Adults with self-reported diabetes from the Medical Expenditure Panel Survey (2011-2013) were identified. Reliability (internal consistency and test-retest) and validity (construct, concurrent, criterion, and predictive) of the SF-12v2 were assessed. The SF-12v2 consists of two normalized composite scores: the physical component summary score (PCS12) and the mental component summary score (MCS12). Confirmatory factor analysis was conducted to assess the instrument structure. Concurrent (convergent and discriminant) validity was assessed by a multitrait-multimethod matrix using the Patient Health Questionnaire, the Kessler Scale, and perceived health and mental health questions. The predictive validity was assessed by estimating future limitations. The concurrent validity was tested by comparing the MCS12, PCS12, and utility scores (six-dimensional health state short form) across comorbidity scores. RESULTS: The final sample comprised 2214 diabetic patients with mean normalized (population mean 50; range 0-100) PCS12 and MCS12 scores of 40.81 (standard error 0.33) and 49.82 (standard error 0.26), respectively. The PCS12 and MCS12 scores showed good internal consistency (Cronbach α: PCS12 0.85; MCS12 0.83) and acceptable test-retest reliability (intraclass correlation coefficient: PCS12 0.72; MCS12 0.63) and produced acceptable goodness-of-fit indices (normed fit index 0.95; comparative fit index 0.95; root mean square error of approximation 0.11 [95% confidence interval 0.1017-0.1188]). The PCS12 and MCS12 were moderately correlated with perceived health and perceived mental health. The MCS12 was highly correlated with the Patient Health Questionnaire and the Kessler Scale. Both the PCS12 and the MCS12 could predict the future health limitations. The PCS12, MCS12, and utility scores demonstrated sensitivity to the presence of comorbidity scores. CONCLUSIONS: The SF-12v2 is a valid generic instrument for measuring quality of life in diabetic patients.

Evaluation of opioid use among patients with back disorders and arthritis.

PURPOSE: Long-term opioid use for chronic pain has increased, but limited evidence exists on its benefits. Evaluation of long-term benefits in pain is based on patient-reported measures such as health-related quality of life (HRQoL). This study examined the long-term effects of opioid use on HRQoL and its subdomains in patients with back pain or arthritis by comparing opioid users to non-opioid users for three metrics: (1) any opioid use, (2) duration of opioid use, and (3) average daily morphine equivalent dose. METHODS: A nationally representative sample of cancer-free adults with chronic back pain or arthritis was selected. Using the 12-Item Short Form Survey, HRQoL measures of Mental Component Score (MCS), Physical Component Score (PCS), and individual subdomains were assessed at baseline and 1 year later. Opioid users were matched to non-opioid users in a 1:1 greedy match using propensity scores estimated based on many patient demographics and baseline HRQoL measures. RESULTS: At year one, PCS was significantly lower among opioid users, mostly driven by bodily pain subdomain; MCS was not different. Short-term opioid users (< 1 month) had higher MCS while long-term users (≥ 1 month) had lower PCS. Low-dose [< 20 morphine milligram equivalents (MME)/day] opioid use was associated with lower PCS, while no difference was found between high dose (≥ 20 MME/day) and non-opioid users. However, most differences were not clinically significant. CONCLUSIONS: Long-term opioid use is not associated with improvements in HRQoL. Clinicians should carefully evaluate the need for opioid use, especially long-term use in managing chronic back pain and arthritis.

Correction to: Frequency and predictors of health services use by native Hawaiians and Pacific islanders: evidence from the U.S. National Health Interview Survey.

Following publication of the original article [1], the author reported the following errors in Table 1 and Table 2.

Frequency and predictors of health services use by Native Hawaiians and Pacific Islanders: evidence from the U.S. National Health Interview Survey.

BACKGROUND: Native Hawaiians and Pacific Islanders (NHPIs) are one of the fasting growing racial groups in the United States (US). NHPIs have a significantly higher disease burden than the US population as a whole, yet they remain underrepresented in research. The purpose of this study is to examine factors associated with health care utilization among NHPIs. METHODS: Drawing from the 2014 NHPI-National Health Interview Survey, we used stereotype logistic regressions to examine utilization of emergency department (ED) and outpatient services among 2172 individuals aged 18 and older. RESULTS: NHPIs with chronic diseases were twice as likely to be multiple ED users and nearly four times as likely to be frequent-users of outpatient services. Social support played a protective role in preventing multiple use of ED. Having a usual source of care made it more than eight times as likely to be a frequent-user of outpatient services. Use of eHealth information increased the odds of using ED and outpatient services. Ability to afford health care increased the odds of using outpatient services. There was no association between health insurance coverage and use of ED and outpatient services among NHPIs. CONCLUSIONS: This research provides the first available national estimates of health services use by NHPIs. Efforts to improve appropriate use of health services should consider leveraging the protective factors of social support to reduce the odds of frequent ED use, and having a usual source of care to increase use of outpatient services.

Do Insurance Mandates Affect Racial Disparities in Outcomes for Children with Autism?

Objective The study investigated whether state mandates for private insurers to provide services for children with autism influence racial disparities in outcomes. Methods The study used 2005/2006 and 2009/2010 waves of the National Survey of Children with Special Health Care Needs. Children with a current diagnosis of autism were included in the sample. Children residing in 14 states and the District of Columbia that were not covered by the mandate in the 2005/2006 survey, but were covered in the 2009/2010 survey, served as the mandate group. Children residing in 32 states that were not covered by a mandate in either wave served as the comparison group. Outcome measures assessed included care quality, family economics, and child health. A difference-in-difference-in-differences (DDD) approach was used to assess the impact of the mandates on racial disparities in outcomes. Results Non-white children had less access to family-centered care compared to white children in both waves of data, but this difference was not apparent across mandate and comparison states as only the comparison states had significant differences. Parents of non-white children reported paying less in annual out-of-pocket expenses compared to parents of white children across waves and groups. DDD estimates did not provide evidence that the mandates had statistically significant effects on improving or worsening racial disparities for any outcome measure. Conclusions This study did not find evidence that state mandates on private insurers affected racial disparities in outcomes for children with autism.

Exploring Implementation of m-Health Monitoring in Postpartum Women with Hypertension.

BACKGROUND: Preeclampsia is a hypertensive disorder in pregnancy where a patients' blood pressure and warning signs of worsening disease need to be closely monitored during pregnancy and the postpartum period. INTRODUCTION: No studies have examined remote patient monitoring using mobile health (m-health) technologies in obstetrical care for women with preeclampsia during the postpartum period. Remote monitoring and m-health technologies can expand healthcare coverage to the patient's home. This may be especially beneficial to patients with chronic conditions who live far from a healthcare facility. MATERIALS AND METHODS: The study was designed to identify and examine the potential factors that influenced use of m-health technology and adherence to monitoring symptoms related to preeclampsia in postpartum women. A sample of 50 women enrolled into the study. Two participants were excluded, leaving a total sample size of 48 women. Users were given m-health devices to monitor blood pressure, weight, pulse, and oxygen saturation over a 2-week period. Nonusers did not receive equipment. The nurse call center monitored device readings and contacted participants as needed. Both groups completed a baseline and follow-up survey. RESULTS: Women who elected to use the m-health technology on average had lower levels of perceived technology barriers, higher facilitating condition scores, and higher levels of perceived benefits of the technology compared with nonusers. Additionally, among users, there was no statistical difference between full and partial users at follow-up related to perceived ease of use, perceived satisfaction, or perceived benefits. DISCUSSION: This study provided a basis for restructuring the management of care for postpartum women with hypertensive disorders through the use of m-health technology. CONCLUSION: Mobile health technology may be beneficial during pregnancy and the postpartum period for women with preeclampsia to closely manage and monitor their blood pressure and warning signs of worsening disease.

Qualitative Analysis of Pre and Postpromotion/Tenure Review Processes Employed by US Pharmacy Schools.

OBJECTIVE: Policies related to prepromotion/tenure reviews and postpromotion/tenure reviews are critical to faculty advancement and retention. The objective of this study is to describe the utilization, timing, and application of such policies as described within promotion and/or tenure documents from US colleges/schools of pharmacy. METHODS: PT documents were collected from internet searches and/or contact with administrators at each institution. Qualitative content analysis was used to systematically review policies related to pre and postpromotion/tenure reviews. Policies were reviewed for required vs optional status, timing, possible outcomes, and other characteristics. RESULTS: PT documents were analyzed from 121 (85%) colleges/schools. Of these, 26% included policies for prepromotion review of nontenure-track faculty, while 45% included pretenure reviews for tenure-track faculty. The majority of prereviews were required (65% and 91%, respectively) and conducted after 3 years in rank on average. Only 22 (18%) included postpromotion/tenure reviews, with most (17, 77%) conducting reviews after a prespecified time in advanced rank (mean 3.9 years). Potential negative consequences of postpromotion/tenure reviews were more frequently described than potential rewards. CONCLUSION: This analysis of promotion and/or tenure documents revealed that pre/posttenure reviews were more commonly employed than pre/postpromotion reviews. Documents most frequently described potential negative consequences that may result from unsatisfactory postpromotion/tenure reviews. Academic leaders should consider the implications of these trends within their own institutions and how their own policies may be improved to create clearly articulated, fair, and parallel processes for both tenure-track and nontenure-track faculty.

Perceptions of tech-based mental health screening.

Background: An estimated one-third of patients experience post-traumatic stress disorder (PTSD) or depression in the year following a traumatic injury. The American College of Surgeons requires postinjury PTSD and depression screening in trauma centers, although implementation has been limited. Tech-based solutions have been proposed to improve uptake of postinjury mental health screening. The goals of this pilot study were to assess the usability and acceptability of Blueprint, a tech-based mental health screening platform, and explore attitudes toward tech-based screening and intervention. Methods: This pilot study included trauma patients (n=10) admitted to the trauma service. Participants completed the PTSD Checklist-5 and Patient Health Questionnaire-9 using Blueprint to test usability and acceptability of the platform. Participants completed the System Usability Scale (SUS) and a semi-structured interview to assess several domains including attitudes toward tech-based screening, potential barriers to implementation, and its usefulness in a postinjury context. Summative Template Analysis, a data abstraction procedure, was used to analyze qualitative data. Results: Blueprint received an average SUS score of 93.25/100 suggesting participants found the interface to be an 'excellent' means to assess postinjury mental health concerns. Participants were supportive of universal screening and identified several benefits to engaging in tech-based routine monitoring of postinjury PTSD and depressive symptoms including convenience, personalization, and trauma-informed care. Regarding intervention, patients valued web-based psychoeducation on topics related to their overall care and local resources. Conclusions: Tech-based mental health screening was highly usable and valuable to trauma patients at risk for postinjury PTSD and depression. Participants valued web-based psychoeducation and resources, but overall preferred Blueprint be used to facilitate access to in-person mental health services. Further evaluation of Blueprint as a means of assessment, intervention, and referral is needed.

Mixed-methods research to support the use of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library.

BACKGROUND: No specific measures exist to assess patient-reported symptoms experienced by individuals with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle cell lymphoma (MCL). This study was conducted to elicit patient-reported CLL/SLL- and MCL-related symptoms and their impact on patients' lives. The study qualitatively and quantitatively evaluated sets of conceptually-selected EORTC Item Library items for assessing CLL/SLL- and MCL-related symptoms. METHODS: The qualitative component of the research included a literature review, clinician consultations, and patient interviews. Concepts important to patients were identified and coded; cognitive debriefing of the selected library items was completed with patients. CLL/SLL and MCL-related symptoms and impacts were organized in a structured conceptual model, which was mapped to item sets from the Item Library. The quantitative component comprised exploratory macro-level Rasch measurement theory (RMT) analysis conducted to provide supportive quantitative insight on the item sets. RESULTS: 41 patients (21-MCL; 20-CLL/SLL) and 5 clinicians participated in the qualitative study; 57 unique patients (30-MCL; 27-CLL/SLL) completed the EORTC items. The conceptual models generated from the qualitative work included symptoms and functional impacts of CLL/SLL and MCL. Symptom domains included swollen lymph nodes, B symptoms, abdominal issues, pain, fatigue, subjective cognitive impairment, anemia-related symptoms, bleeding, infection, and other issues (appetite loss, temperature fluctuation, rash, weight gain, sleep problems, cough). Impacts included physical function, role function, and other functions (psychological, social). Cognitive debriefing demonstrated that the separate item sets for CLL/SLL and MCL-related symptoms were well understood and aligned with patients' experiences. All selected items were included in the conceptual models. The exploratory RMT analysis showed that the item sets provided adequate coverage of the continuum of CLL/SLL- and MCL-related symptom severity. CONCLUSIONS: This study gathered qualitative and early quantitative evidence supporting use of the EORTC Item Library to assess CLL/SLL- and MCL-related symptoms and impacts. These items are promising candidates for measurement of patient-reported disease symptoms in these populations. A larger sample size will be essential to establish the psychometric properties necessary to support use in clinical trials. Patients who suffer from rare cancers of the blood, bone marrow, and lymph nodes can experience chronic and debilitating symptoms. At present, however, there are no dedicated instruments for assessing the patient's experience of symptoms of conditions like chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle cell lymphoma (MCL), or for assessing their impact on patients' lives. This research project aimed to address that need. The researchers selected relevant and clinically meaningful symptoms from the EORTC Item Library that assess fatigue, B symptoms, and CLL/SLL- and MCL-specific symptoms. Using patients and clinician interviews as well as quantitative analyses, the research revealed no major concerns with using these item sets to assess symptoms of CLL/SLL and MCL. Interviews with patients demonstrated that the separate item sets for CLL/SLL and MCL-related symptoms were well understood and aligned with patients' experiences. All selected items were included in the conceptual models. Item sets identified in this study can potentially be used to assess patient-reported symptom endpoints in clinical trial settings in these disease areas.

Association of race/ethnicity and patient care experiences with healthcare utilization and healthcare costs among prostate cancer survivors: A SEER-CAHPS study.

INTRODUCTION: This study aimed to evaluate the association of race/ethnicity and patient care experiences (PCEs) with healthcare utilization and costs among US older adults with prostate cancer (PCa). MATERIALS AND METHODS: The study used data from 2007 to 2015 Surveillance, Epidemiology, and End Results dataset linked to Medicare Consumer Assessment of Healthcare Providers and Systems survey and Medicare claims (SEER-CAHPS). We identified males aged ≥65 years who completed a CAHPS survey within 6-60 months post-PCa diagnosis. Covariate-adjusted associations of six CAHPS PCE composite measures with any emergency department visit and any inpatient stay (using logistic regressions), and with total part A and part B Medicare costs (using generalized linear models) were examined by race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, non-Hispanic Asian, and other). RESULTS: Among 1834 PCa survivors, a 1-point higher score for getting care quickly was associated with higher odds (odds ratio 1.08; 95% confidence interval [CI]: 1.02-1.15; p = 0.009) of any inpatient stay in Hispanic patients. Higher total costs were associated with a 1-point higher score for getting needed care among Hispanic patients ($590.84; 95% CI: $262.15, $919.53; p < 0.001); a 1-point higher score for getting care quickly among Hispanic patients ($405.26; 95% CI: $215.83, $594.69; p < 0.001); and a 1-point higher score for customer service among patients belonging to other races ($361.69; 95% CI: $15.68, $707.69; p = 0.04). DISCUSSION: We observed differential associations by race/ethnicity between PCEs and healthcare utilization and costs. Further research is needed to explore the causes of these associations.

Impact of psychosocial factors on the success of neuromodulation treatment for patients with persistent pain.

INTRODUCTION: Significant interindividual variability in spinal cord stimulation (SCS) outcomes exists. Due to its high cost and risks of complications, criteria to guide patient selection for SCS trials and their outcomes would be helpful. With increased focus on the use of patient-reported outcomes to improve care, we aim to evaluate the National Institute of Health Patient Reported Outcome Measurement Information System measures for an association with successful SCS trials in patients with persistent pain. METHODS: Our prospective, observational study enrolled 60 patients with persistent pain who underwent an SCS trial. Patients completed demographic and Patient Reported Outcome Measurement Information System computer adaptive test (PROMIS CAT) assessments to measure self-reported pain interference, depression, anxiety, physical functioning, and sleep disturbance at the time they presented for placement of their trial device. RESULTS: Of the 58 patients who underwent successful electrode placement, 11 had an unsuccessful trial. There were no differences in patient demographics between patients with a successful and an unsuccessful trial. Patients who had a successful SCS trial reported lower pre-trial levels of anxiety, depression, and sleep disturbance and decreased post-trial levels of depression, sleep disturbance, and pain interference. CONCLUSIONS: We found that patients with high levels of depression, anxiety, and sleep disturbance using the PROMIS CAT were predictive of unsuccessful trials. In addition, we found that patients with successful SCS trials reported lower levels of these domains on PROMIS CAT administered at the end of the trial.