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Background This study compares classical test theory and item response theory frameworks to determine reliable change. Reliable change followed by anchoring to the change in categorically distinct responses on a criterion measure is a useful method to detect meaningful change on a target measure. Methods Adult cancer patients were recruited from five cancer centers. Baseline and follow-up assessments at 6 weeks were administered. We investigated short forms derived from PROMIS® item banks on anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance. We detected reliable change using reliable change index (RCI). We derived the T-scores corresponding to the RCI calculated under IRT and CTT frameworks using PROMIS® short forms. For changes that were reliable, meaningful change was identified using patient-reported change in PRO-CTCAE by at least one level. For both CTT and IRT approaches, we applied one-sided tests to detect reliable improvement or worsening using RCI. We compared the percentages of patients with reliable change and reliable/meaningful change. Results The amount of change in T score corresponding to RCICTT of 1.65 ranged from 5.1 to 9.2 depending on domains. The amount of change corresponding to RCIIRT of 1.65 varied across the score range, and the minimum change ranged from 3.0 to 8.2 depending on domains. Across domains, the RCICTT and RCIIRT classified 80% to 98% of the patients consistently. When there was disagreement, the RCIIRT tended to identify more patients as having reliably changed compared to RCICTT if scores at both timepoints were in the range of 43 to 78 in anxiety, 45 to 70 in depression, 38 to 80 in fatigue, 35 to 78 in sleep disturbance, and 48 to 74 in pain interference, due to smaller standard errors in these ranges using the IRT method. The CTT method found more changes compared to IRT for the pain intensity domain that was shorter in length. Using RCICTT, 22% to 66% had reliable change in either direction depending on domains, and among these patients, 62% to 83% had meaningful change. Using RCIIRT, 37% to 68% had reliable change in either direction, and among these patients, 62% to 81% had meaningful change. Conclusion Applying the two-step criteria demonstrated in this study, we determined how much change is needed to declare reliable change at different levels of baseline scores. We offer reference values for percentage of patients who meaningfully change for investigators using the PROMIS instruments in oncology.

Supplementary Table 1 from Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer

Prior studies suggest that tumor cell lines harboring RAS mutations display remarkable sensitivity to gemcitabine and etoposide. In a phase II clinical trial of patients with locally advanced or metastatic pancreatic cancer, we evaluated the response rate to a combination of these drugs. Forty chemo-naïve patients with nonresectable and histologically confirmed pancreatic cancer were accrued. Patients received gemcitabine 1,000 mg/m2 (days 1 and 8) and etoposide 80 mg/m2 (days 8, 9, and 10; 21-day cycle). The primary end point was radiological response rate. Secondary objectives were determination of overall survival, response duration (time to progression), quality of life, toxicity, and CA 19-9 biomarker response. In 35 evaluable patients, 10 exhibited a radiological partial response and 12 had stable disease in response to treatment. Twenty patients exhibited a >20% decrease in CA 19-9 biomarker levels. Median overall survival was 6.7 months for all patients (40) and 7.2 months for evaluable patients (35). Notably, four patients survived for longer than 1 year, with two patients surviving for more than 2 years. Median time to progression for evaluable patients was 3.1 months. The median overall survival for locally advanced patients was 8.8 months and 6.75 months for metastatic patients. One-year survival was 10% for all patients and 11.4% for evaluable patients. Quality of life improved in 12 patients and remained stable in 3 of the evaluable patients. The primary dose-limiting toxicities were hematologic toxicity and fatigue. These results show that the gemcitabine and etoposide combination is generally well-tolerated and exhibits a response rate similar to other published studies. Mol Cancer Ther; 9(8); 2423–9. ©2010 AACR.

Supplementary Form 1 from Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer

Background In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered. Methods This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach’s alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran–Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent. Results A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach’s alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106. Conclusion The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.

The development of major low anterior resection syndrome (LARS) after low anterior resection is severely detrimental to quality of life, yet awareness of it by clinicians and patients and the frequency of treatment of LARS is unclear.Patients who underwent low anterior resection for sigmoid or rectal cancer at a tertiary center between 2007 and 2017 (n = 798) were surveyed in 2019 to assess LARS symptoms and report medications or treatment received for LARS. LARS scores were calculated (score range 0-42) and normalized to published data on LARS prevalence in the general population in Europe, stratified by age (50 or ≥50) and sex.Of the 594 patients (74%) who returned the survey, 255 (43%) were identified as having major LARS (LARS score ≥30). This prevalence was significantly higher than published normative data from Denmark and Amsterdam when stratified by age greater than or less than 50 and sex. Patients with major LARS infrequently reported current use of first-line therapies (antidiarrheal medications 32%, fiber supplements 16%, and both 13%). Only 3% reported receiving second-line therapy of transanal irrigations and/or pelvic floor rehabilitation, and only 1% had undergone third-line therapy of sacral nerve stimulator implantation.Major LARS is common yet seemingly underrecognized by clinicians because less than half of patients are on first-line therapy and practically none are on second- and third-line therapies. Long-term follow-up of patients after low anterior resection, improved preoperative and postoperative education, and continued symptom assessment is necessary to improve treatment of major LARS.

TAPUR is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. The results of a cohort of patients with colorectal cancer (CRC) withEligible patients had advanced CRC, no standard treatment options, measurable disease (RECIST), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, tumors withThirty patients were enrolled from August 2016 to August 2018; all had CRC with aThe combination of C + V has antitumor activity in heavily pretreated patients with CRC with

BACKGROUND The pattern of perioperative use of personal electronic devices (PEDs) among anesthesia providers in the United States is unknown. METHODS We developed a 31-question anonymous survey of perioperative PED use that was sent to 813 anesthesiologists, anesthesiology residents, and certified registered nurse anesthetists at 3 sites within one health system. The electronic survey assessed patterns of PED use inside the operating room (OR), outside the OR, and observed in others. Questions were designed to explore the various purposes for PED use, the potential impact of specific hospital policies or awareness of medicolegal risk on PED use, and whether PED was a source of perioperative distraction. RESULTS The overall survey response rate was 36.8% (n = 299). With regard to often/frequent PED activity inside the OR, 24% reported texting, 5% reported talking on the phone, and 11% reported browsing on the Internet. With regard to often/frequent PED activity outside the OR, 88% reported texting, 26% reported talking on the phone, and 63% reported browsing the Internet. With regard to often/frequent PED activity observed in others, 52% reported others texting, 14% reported others talking on the phone, and 34% reported others browsing the Internet. Two percent of respondents self-reported a distraction compared to 15% who had observed a distraction in others. Eighty percent of respondents recognized PED as a potential distraction for patient safety. CONCLUSIONS Our data reinforce that PED use is prevalent among anesthesia providers.

To compare patient-reported outcomes before and after implementation of evidence-based, procedure-specific opioid prescribing guidelines.The opioid epidemic remains a significant public health issue. Many institutions have responded by reducing opioid prescribing after surgery. However, the impact of this on patient-reported outcomes remains poorly understood.Opioid-naïve adults undergoing 12 elective general surgery procedures at a single institution prospectively completed telephone surveys at median 26 days from discharge. Patients were compared before (3/2017-1/2018) and after (5/2019-11/2019) implementation of evidence-based, procedure-specific opioid prescribing guidelines.603 pre-guideline and 138 post-guideline patients met inclusion criteria and completed surveys. 60.5% of pre-guideline and 92.5% of post-guideline prescriptions fell within recommendations ( P0.001), while refill rates were similar (4.5% vs. 5.8%, P =0.50). A statistically significant drop in median Morphine Milligram Equivalent prescribed was observed for 9 out of 12 procedures (75%). No opioids were prescribed for 16.7% of patients in both cohorts ( P =0.98). While 93.3% of pre-guideline and 87.7% of post-guideline patients were very/somewhat satisfied with their pain control, the proportion of patients who were very/somewhat dissatisfied increased from 4.2% to 9.4% ( P =0.039).Prescribing guidelines successfully reduced opioid prescribing without increased refill rates. Despite decreased prescribing overall, there was a continued reluctance to prescribe no opioids after surgery. Although most patients experienced good pain control, there remains a subset of patients whose pain is not optimally managed in the era of reduced opioid prescribing.

The objective of this study was to assess the criterion validity of score thresholds for the Upper Digestive Disease (UDD) App.From December 15, 2017, to December 15, 2020, patients presenting after esophagectomy were offered the UDD App concurrent with a provider visit. This tool consists of 67 questions including 5 novel domains. Score thresholds were used to assign patients to a good, moderate, or poor category on the basis of domain scores. Providers were given performance descriptions for each domain and asked to assign patients to a category on the basis of their clinical evaluation. The weighted κ statistic was used to determine the magnitude of agreement between classifications based on the patients' UDD App scores and the providers' clinical evaluation.Fifty-nine patients in the study (76% male; median age, 63 years [interquartile range, 57-72 years]) reported outcomes using the UDD App. Providers reviewed between 1 and 10 patients at a median time of 296.5 days (interquartile range, 50-975 days) after esophagectomy. The magnitude of agreement between patients and providers was moderate for dysphagia (κ = 0.52; P.001) and reflux (κ = 0.42; P.001). Dumping-related hypoglycemia (κ = 0.03; P = .148), gastrointestinal complaints (κ = 0.02; P = .256), and pain (κ = 0.05; P.184) showed minimal agreement, with providers underestimating the symptoms and problems reported by patients in these domains.Although there was agreement between UDD App assessment and provider evaluation of dysphagia and reflux after esophagectomy, there was discordance of scoring for dumping-related symptoms and pain. Future research is needed to determine whether thresholds for pain and dumping domains need to be revised or whether additional provider education on performance descriptions is needed.

The past decade witnessed a rapid rise in the public reporting of surgeon- and hospital-specific quality-of-care measures. However, patients’ interpretations of star ratings and their importance relative to other considerations (for example, cost, distance traveled) are poorly understood. We conducted a discrete choice experiment in an outpatient setting (an academic joint arthroplasty practice) to study trade-offs that patients are willing to make in choosing a provider for a hypothetical total joint arthroplasty. Two hundred consecutive new patients presenting for hip or knee pain in 2018 were included. The average patient was willing to pay $2,607 and $3,152 extra for an additional hospital or physician star, respectively, and an extra $11.45 to not travel an extra mile for arthroplasty care. History of prior surgery and prior experience with rating systems reduced the relative value of an incremental star by $539.25 and $934.50, respectively. Patients appear willing to accept significantly higher copayments for higher quality of care, and surgeon quality seems relatively more important than hospital quality. Further study is needed to understand the value and trust patients place in publicly reported hospital and surgeon quality ratings.

OBJECTIVE Facial nerve function, hearing preservation, and tumor control have been the primary benchmarks used to assess vestibular schwannoma (VS) outcomes. Acknowledging the frequent discrepancy between what physicians prioritize and what patients value, there has been increasing prioritization of patient-reported outcome measures when evaluating the impact of VS diagnosis and its treatment. Motivated by reported limitations of prior instruments used to assess quality of life (QOL) in patients with VS, the authors describe the development and validation of a new disease-specific QOL measure: the Vestibular Schwannoma Quality of Life (VSQOL) Index. METHODS The content development phase comprised identification of clinically important domains and prioritization of feelings or concerns individuals with VS may have. The validation phase encompassed determining how items were grouped into domains and eliminating redundant items. Both phases leveraged data from cross-sectional and longitudinal surveys, expertise from a multidisciplinary working group, and patients with a broad range of experiences with VS (n = 42 during content development and n = 263 during validation). Domain scores from the new instrument were assessed for reliability and correlation with other measures of similar constructs. RESULTS The VSQOL Index consists of 40 items that evaluate the impact of VS diagnosis and its management on QOL, treatment satisfaction, and employment and is estimated to take 8–10 minutes to complete. Domain scores range from 0 (worst) to 100 (best) and demonstrate excellent psychometric properties, including content, construct, and convergent validity and both internal consistency (Cronbach’s alphas 0.83 to 0.91) and test-retest reliability (reliability coefficients 0.86 to 0.96). CONCLUSIONS The VSQOL Index is a valid and reliable measure that overcomes several limitations of prior instruments, including omission or underrepresentation of domains that frequently impact well-being, such as pain, cognition, satisfaction or regret surrounding treatment decisions, and occupational limitations, to comprehensively evaluate the impact of VS diagnosis or its treatment on QOL.

ObjectiveEndometrial cancer surgical staging includes lymph node assessment which can lead to lower extremity lymphedema. The aim of this study was to estimate prevalence after sentinel lymph node biopsy versus lymphadenectomy.MethodsConsecutive patients who underwent minimally invasive surgery at the Mayo Clinic, Rochester, Minnesota, USA, between January 2009 and June 2016 for newly diagnosed endometrial cancer were mailed our validated 13 item lower extremity lymphedema screening questionnaire. We also ascertained via questionnaire whether the patient was ever diagnosed with lower extremity lymphedema.ResultsAmong 378 patients included in the analysis, 127 (33.5%) had sentinel lymph node biopsy with or without side specific lymphadenectomy (sentinel lymph node cohort) and 251 (66.4%) underwent bilateral lymphadenectomy prior to sentinel lymph node biopsy implementation at our institution or as 'backup' after sentinel lymph node mapping (lymphadenectomy cohort). The prevalence of lower extremity lymphedema was 41.5% (157/378), with 69 patients (18.3%) self-reporting a lower extremity lymphedema diagnosis after their endometrial cancer surgery at a median of 54.3 months (interquartile range 31.2–70.1 months), and an additional 88 patients (23.3%) identified by the screening questionnaire. The prevalence of lower extremity lymphedema was significantly higher in the lymphadenectomy cohort compared with the sentinel lymph node group (49.4% (124/251) vs 26.0% (33/127); pConclusionsSentinel lymph node biopsy was associated with a decreased risk of post-treatment lymphedema compared with lymphadenectomy in patients who underwent surgical staging for endometrial carcinoma.

Background: Health literacy is an area of growing research and clinical interest, necessitating short, accurate measures of this complex construct. Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT) measures prose, document, and quantitative literacy by self-administration on a touchscreen computer. Objective: The objective of this study was to assess the validity of a short form of Health LiTT and to identify a meaningful cutoff score for adequate health literacy. Methods: A subsample of 137 participants from the Literacy and Cognitive Function among Older Adults study completed a 10-item Health LiTT short form and three interviewer-administered health literacy measures: Test of Functional Health Literacy in Adults (TOFHLA), Rapid Estimate of Adult Literacy in Medicine (REALM), and Newest Vital Sign (NVS). Convergent validity was assessed by correlating scores for all measures, and known-groups validity was assessed by comparing mean Health LITT scores across TOFHLA levels (inadequate, marginal, adequate). Internal consistency reliability was estimated with Cronbach's alpha. A cutoff score for adequate health literacy was established using the TOFHLA cutoff for adequate versus inadequate/marginal health literacy. Key Results: Spearman correlations between Health LiTT scores and total TOFHLA, REALM, and NVS scores were 0.65, 0.69, and 0.56, respectively (all p < .001). Mean Health LiTT scores were significantly and meaningfully different across inadequate (40.4), marginal (50.1), and adequate (57.1) TOFHLA categories (F = 60.6; p < .001). Cronbach's alpha for the Health LiTT short form was .73. A cutoff score of 55 on Health LiTT showed acceptable sensitivity and specificity to identify adequate health literacy. Conclusions: This 10-item Health LiTT short form demonstrated excellent convergent and known-groups validity and acceptable internal consistency reliability in older adults. The established cutoff also showed excellent sensitivity and specificity. Validation of other custom Health LiTT short forms with varying items from the bank and computer adaptive test-generated Health LiTT scores is ongoing. [ HLRP: Health Literacy Research and Practice . 2020;4(4):e200–e207.] Plain Language Summary: This article provides evidence of the need for and psychometric properties of a valid and reliable short form of the flexible, technologically advanced Health Literacy Assessment Using Talking Touchscreen Technology measure, as well as a cutoff score to note adequate versus marginal/inadequate health literacy.

Objectives The purpose of this study was to determine if health literacy is associated with mortality, hospitalizations, or emergency department (ED) visits among patients living with heart failure (HF). Background Growing evidence suggests an association between health literacy and health-related outcomes in patients with HF. Methods We searched Embase, MEDLINE, PsycINFO, and EBSCO CINAHL from inception through January 1, 2019, with the help of a medical librarian. Eligible studies evaluated health literacy among patients with HF and assessed mortality, hospitalizations, and ED visits for all causes with no exclusion by time, geography, or language. Two reviewers independently selected studies, extracted data, and assessed the methodological quality of the identified studies. Results We included 15 studies, 11 with an overall high methodological quality. Among the observational studies, an average of 24% of patients had inadequate or marginal health literacy. Inadequate health literacy was associated with higher unadjusted risk for mortality (risk ratio [RR]: 1.67; 95% confidence interval [CI]: 1.18 to 2.36), hospitalizations (RR: 1.19; 95% CI: 1.09 to 1.29), and ED visits (RR: 1.17; 95% CI: 1.03 to 1.32). When the adjusted measurements were combined, inadequate health literacy remained statistically associated with mortality (RR: 1.41; 95% CI: 1.06 to 1.88) and hospitalizations (RR: 1.12; 95% CI: 1.01 to 1.25). Among the 4 interventional studies, 2 effectively improved outcomes among patients with inadequate health literacy. Conclusions In this study, the estimated prevalence of inadequate health literacy was high, and inadequate health literacy was associated with increased risk of death and hospitalizations. These findings have important clinical and public health implications and warrant measurement of health literacy and deployment of interventions to improve outcomes.

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study identifies signals of antitumor activity of commercially available targeted agents in patients with advanced cancers that harbor genomic alterations known as drug targets. In this article, data from two cohorts of patients with pancreatic and biliary cancers withEligible patients age 12 years and older with advanced measurable or evaluable solid tumors are provided treatment according to protocol-specified genomic matching rules. The primary study end point is objective response or stable disease of at least 16 weeks duration. For each cohort, a Simon two-stage design was used with a futility evaluation after 10 patients. Secondary end points include safety, progression-free survival (PFS), and overall survival (OS).Between July 2016 and November 2017, 12 and 10 patients with pancreatic and biliary cancer, respectively, withPalbociclib monotherapy does not have clinical activity in patients with advanced pancreatic or biliary cancers with

Background Several registry-based analyses suggested a survival advantage for married versus single patients with pancreatic cancer. The mechanisms underlying the association of marital status and survival are likely multiple and complex and, therefore, may be obscured in analyses generated from large population-based databases. The goal of this research was to characterize this potential association of marital status with outcomes in patients with resected pancreatic cancer who underwent combined modality adjuvant therapy on a prospective clinical trial. Materials and methods This is an ancillary analysis of 367 patients with known marital status treated on NRG Oncology/RTOG 97-04. Survival analysis was performed using the Kaplan-Meier method and compared using the log-rank test. Multivariate analysis was performed using the Cox proportional hazards regression model. Results Of 367 patients, 271 (74%) were married or partnered and 96 (26%) were single. Married or partnered patients were more likely to be male. There was no association between marital status and overall survival (OS) or disease-free survival (DFS) on univariate (hazard ratio [HR], 1.09 and 1.01, respectively) or multivariate analyses (HR, 1.05 and 0.98, respectively). Married or partnered male patients did not have improved survival compared with female or single patients. Conclusion Ancillary analysis of data from NRG Oncology/RTOG 97-04 demonstrated no association between marital and/or partner status and OS or DFS in patients with resected pancreatic cancer who received adjuvant postoperative chemotherapy followed by concurrent external beam radiation therapy and chemotherapy. Clinical trial identification number. NCT00003216. Implications for practice Several population-based studies have shown an epidemiological link between marital status and survival in patients with pancreatic cancer. A better understanding of this association could offer an opportunity to improve outcomes through psychosocial interventions designed to mitigate the negative effects of not being married. Based on the results of this analysis, patients who have undergone a resection and are receiving adjuvant therapy on a clinical trial are unlikely to benefit from such interventions. Further efforts to study the association between marital status and survival should be focused on less selected subgroups of patients with pancreatic cancer.

Objective To collect patient-reported outcomes after esophagectomy to establish a set of preliminary normative standards to aid in symptom-score interpretation. Patients and Methods Patients undergoing esophagectomy often have little understanding about postoperative symptom management. The Mayo Clinic esophageal CONDUIT tool is a validated questionnaire comprising 5 multi-item symptom-assessment domains and 2 health-assessment domains. A prospective nonrandomized cohort study was conducted on adult patients who have had esophagectomies using the CONDUIT tool from August 17, 2015, to July 30, 2018 (NCT02530983). The Statistical Analysis System v9.4 (SAS Institute Inc., Cary, NC) was used to calculate and analyze the scores. Results Over the study period, 569 patients were assessed for eligibility, and 241 patients consented and were offered the tool. Of these, 188 patients (median age: 65 years; range: 24 to 87 years; 80% male patients) had calculable scores. Of the 188 patients, 50 (26.6%) patients were identified as potential beneficiaries for educational intervention to improve symptoms (received moderate scores for a domain), and 131 (69.7%) patients were identified as needing further testing or provider intervention (received poor scores for a domain) based on the tool. Conclusion The CONDUIT tool scores, when compared with standardized scales with established preliminary normative scores, could be used to identify and triage patients who need targeted education, further testing, or provider interventions. These score ranges will serve as the first set of normative standards to aid in the interpretation of conduit performance among providers and patients.

PURPOSEThe Targeted Agent and Profiling Utilization Registry (TAPUR) Study identifies signals of antitumor activity of commercially available targeted agents in patients with advanced cancers that harbor genomic alterations known as drug targets. In this article, data from two cohorts of patients with pancreatic and biliary cancers with CDKN2A loss or mutation treated with palbociclib are reported.METHODSEligible patients age 12 years and older with advanced measurable or evaluable solid tumors are provided treatment according to protocol-specified genomic matching rules. The primary study end point is objective response or stable disease of at least 16 weeks duration. For each cohort, a Simon two-stage design was used with a futility evaluation after 10 patients. Secondary end points include safety, progression-free survival (PFS), and overall survival (OS).RESULTSBetween July 2016 and November 2017, 12 and 10 patients with pancreatic and biliary cancer, respectively, with CDKN2A loss or mutation were treated with palbociclib. Twenty evaluable patients (10 per cohort) were included in the analysis. No patients had objective response or stable disease at 16 weeks, and both cohorts were closed. Two patients, neither with response, were determined to be ineligible. All patients were evaluated for safety, PFS, and OS. A median PFS of 7.2 weeks (90% CI, 4.0 to 8.0 weeks) and median OS of 12.4 weeks (90% CI, 4.7 to 23.1 weeks) were observed in the pancreatic cohort. A median PFS of 7.3 weeks (90% CI, 3.9 to 7.9 weeks) and median OS of 11.1 weeks (90% CI, 5.1 to 14.0 weeks) were observed in the biliary cohort. No unexpected toxicities were observed.CONCLUSIONPalbociclib monotherapy does not have clinical activity in patients with advanced pancreatic or biliary cancers with CDKN2A loss or mutation. Toxicity is similar to reported experience with palbociclib in other tumor types.

Cutaneous melanoma is strongly associated with tanning bed use.To describe local residents' knowledge, attitudes, and behavior regarding skin cancer and tanning bed use and to estimate prevalence of high risk for melanoma.A survey was mailed to 886 local residents (549, aged 18-39 years; 337, aged ≥40 years). Logistic and linear regression and univariate and multivariable analysis were used to assess perceived risk and skin cancer knowledge.The response rate was 21%; 55% of the younger group and 37% of the older group had used indoor tanning, and prevalence of high risk for melanoma according to a skin cancer risk calculator was 18% in the younger group and 33% in the older group. Individuals with high risk scores were more likely to correctly perceive that they were at high risk for skin cancer. Most participants with high risk scores and those who previously used tanning beds reported low likelihood of future indoor tanning.Female sex, high risk score, and previous indoor tanning were associated with participants' views of higher skin cancer risk. No specific knowledge gaps were identified. Understanding community residents' attitudes about skin cancer and indoor tanning can help guide interventions.

Background The study tests the effects of data collection modes on patient responses associated with the multi-item measures such as Patient-Reported Outcomes Measurement System (PROMIS®), and single-item measures such as Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Numerical Rating Scale (NRS) measures. Methods Adult cancer patients were recruited from five cancer centers and administered measures of anxiety, depression, fatigue, sleep disturbance, pain intensity, pain interference, ability to participate in social roles and activities, global mental and physical health, and physical function. Patients were randomized to complete the measures on paper (595), interactive voice response (IVR, 596) system, or tablet computer (589). We evaluated differential item functioning (DIF) by method of data collection using the R software package, lordif. For constructs that showed no DIF, we concluded equivalence across modes if the equivalence margin, defined as ± 0.20 × pooled SD, completely surrounds 95% confidence intervals (CI's) for difference in mean score. If the 95% CI fell totally outside the equivalence margin, we concluded systematic score difference by modes. If the 95% CI partly overlaps the equivalence margin, we concluded neither equivalence nor difference. Results For all constructs, no DIF of any kind was found for the three modes. The scores on paper and tablet were more comparable than between IVR and other modes but none of the 95% CI’s were completely outside the equivalence margins, in which we established neither equivalence nor difference. Percentages of missing values were comparable for paper and tablet modes. Percentages of missing values were higher for IVR (2.3% to 6.5% depending on measures) compared to paper and tablet modes (0.7% to 3.3% depending on measures and modes), which was attributed to random technical difficulties experienced in some centers. Conclusion Across all mode comparisons, there were some measures with CI’s not completely contained within the margin of small effect. Two visual modes agreed more than visual-auditory pairs. IVR may induce differences in scores unrelated to constructs being measured in comparison with paper and tablet. The users of the surveys should consider using IVR only when paper and computer administration is not feasible.

Purpose To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making. Methods In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives. Results We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them. Conclusions Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit. Clinical trial registration ClinicalTrial.gov: NCT01502891.

PURPOSE: The Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey is a systematic assessment of health care experiences of patients with cancer. It supports comparisons among all cancer treatment settings and modalities. METHODS: Formative research included 16 focus groups with patients receiving treatment and family members; advice from a panel of oncology and quality improvement experts; and interviews with stakeholders representing oncology associations, accredited cancer centers, and community oncology practices. We conducted cognitive tests of the instrument and field tests at six cancer centers and four community oncology practices, after which the survey was finalized and obtained the CAHPS trademark. RESULTS: The survey includes 56 questions that form six core composite measures (Getting Timely Care; Supporting Patient Self-Management; Available to Provide Care and Information; Provider Communication; Care Coordination; and Courteous Office Staff); two single-item measures of family participation in care and interpreter services; and two global ratings of cancer care and the treatment team. Sixteen additional items form three supplemental composite measures: Shared Decision-Making, Keeping Patients Informed, and Access to Care. CONCLUSION: Mail-only, mail-telephone mixed-mode, and Web-mail mixed-mode data collection methods are recommended. The questionnaires and instructions for use are free and available in English and Spanish on the CAHPS Website ( www.ahrq.gov/cahps ).

Background Little is known about how complementary and alternative medicine (CAM) is discussed in cancer care across varied settings in the U.S. Methods In two practices affiliated with one academic medical center in southern California (SoCal), and one in the upper Midwest (UM), we audio-recorded patient-clinician interactions in medical oncology outpatient practices. We counted the frequency and duration of CAM-related conversations. We coded recordings using the Roter Interaction Analysis System. We used chi-square tests for bivariate analysis of categorical variables and generalized linear models for continuous variables to examine associations between dialogue characteristics, practice setting, and population characteristics with the occurrence of CAM discussion in each setting followed by multivariate models adjusting for clinician clustering. Results Sixty-one clinicians and 529 patients participated. Sixty-two of 529 (12%) interactions included CAM discussions, with significantly more observed in the SoCal university practice than in the other settings. Visits that included CAM were on average 6 minutes longer, with CAM content lasting an average of 78 seconds. In bivariate tests of association, conversations containing CAM included more psychosocial statements from both clinicians and patients, higher patient-centeredness, more positive patient and clinician affect, and greater patient engagement. In a multivariable model including significant bivariate terms, conversations containing CAM were independently associated with higher patient-centeredness, slightly longer visits, and being at the SoCal university site. Conclusion The frequency of CAM-related discussion in oncology varied substantially across sites. Visits that included CAM discussion were longer and more patient centered. Implications for Practice The Institute of Medicine and the American Society of Clinical Oncology have called for more open discussions of complementary and alternative medicine (CAM). But little is known about the role population characteristics and care contexts may play in the frequency and nature of those discussions. The present data characterizing actual conversations in practice complements a much larger literature based on patient and clinician self-report about CAM disclosure and use. It was found that CAM discussions in academic oncology visits varied significantly by practice context, that the majority were initiated by the patient, and that they may occur more when visit time exists for lifestyle, self-care, and psychosocial concerns.

12004 Background: The majority of head/neck (HN) patients who undergo radiotherapy develop RIX. Unfortunately, existing treatments are of limited benefit and have side effects. Initial small studies suggest acupuncture may treat chronic RIX. A multicenter, phase III, randomized, sham-controlled trial (NCT02589938) was conducted to compare true acupuncture (TA) with sham acupuncture (SA) and wait list control (WLC) group in treating chronic RIX. Methods: HN patients with chronic RIX at least 12 months post-RT were recruited through the WF NCORP RB network (2UG1CA189824). Patients must have received bilateral radiation therapy with subsequent grade 2 or 3 xerostomia per modified RTOG scale, with no history of xerostomia or other illness known to affect salivation prior to HN XRT. All patients received standard oral hygiene and were randomized to TA, SA, or WLC. Patients in TA and SA were treated 2 times per week for 4 weeks. Those experiencing a marginal response (10-19 point decrease on the Xerostomia questionnaire (XQ)) received another 4 weeks of the respective treatment. Patients who had no response (increase in XQ score or decrease of < 10 points from baseline), partial response (20 or more point decrease in XQ score from baseline), or complete response (XQ score = 0) did not receive further treatment. Patient outcomes including XQ and FACT-HN were collected at baseline, 4, 8, and 12 weeks; the primary endpoint was XQ at 4 weeks. A sample size of 80 per group (240 total), had 80% power to detect a difference of 10 points between groups, assuming two-sided alpha = 0.013 and 20% attrition. Analysis of covariance adjusted for baseline XQ and Bonferroni corrections for pairwise comparisons. Results: 258 from 33 different practices participated. Average age was 65 years, 78% male, and 67% had AJCC stage IV a,b disease. At week 4, there was a group main effect on the XQ (P = 0.02) revealing significant between group differences between TA and WLC (51.1 vs 56.8, P = 0.008), with marginal between group difference between TA and SA (51.1 vs 54.5, P = 0.066) and no difference between SA and WLC (P = 0.36). A similar pattern was seen at week 8 (TA = 48.3, SA = 50.8, WLC = 54.8; only TA vs WLC significant, P = 0.012) and 12 (TA = 48.6, SA = 49.3.8, WLC = 54.6; TA vs WLC, P = 0.02; SA vs WLC, P = 0.04; TA vs SA, P = 0.79). Incidence of clinically significant RIX (XQ scores > 30) followed a similar pattern. The FACT-HN at week 12 revealed statistically and clinically significant group differences for the total score and several subscales between TA vs SA and WLC with no differences between SA and WLC. Completer and mediation analyses will be presented. Conclusions: True acupuncture was more effective in treating chronic RIX and improving QOL one or more years after the end of XRT than sham acupuncture or standard oral hygiene. Clinical trial information: NCT02589938.

An amendment to this paper has been published and can be accessed via the original article.

Background Researchers and clinicians studying symptoms experienced by people with cancer must choose from various scales. It would be useful to know how the scores on one measure translate to another. Methods Using item response theory (IRT) with the single-group design, in which the same sample answers all measures, we produced crosswalk tables linking five 0–10 numeric rating scale (NRS) and 15 items from Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE, scored on a 1–5 scale) to the T-Score metric of six different scales from the NIH Patient reported Outcomes Measurement Information System (PROMIS®). The constructs, for which we conducted linking, include emotional distress-anxiety, emotional distress-depression, fatigue, sleep disturbance, pain intensity, and pain interference. We tested the IRT linking assumption of construct similarity between measures by comparing item content and testing unidimensionality of item sets comprising each construct. We also investigated the correlation of the measures to be linked and, by inspecting standardized mean differences, whether the linkage is invariant across age and gender subgroups. For measures that satisfied the assumptions, we conducted linking. Results In general, an NRS score of 0 corresponded to about 38.2 on the PROMIS T-Score scale (mean = 50; SD = 10); whereas an NRS score of 10 corresponded to a PROMIS T-Score of approximately 72.7. Similarly, the lowest/best score of 1 on PRO-CTCAE corresponded to 39.8 on T-score scale and the highest/worst score of 5 corresponded to 72.0. Conclusion We produced robust linking between single item symptom measures and PROMIS short forms.

Introduction The purpose of this study was to find out whether 3-dimensional (3D)-printed models improved the learners' ability to identify liver segments. Methods A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images. Adjusted multilevel-mixed models were used to compare scores at baseline and after 3D and 2D. Results Accuracy in identifying hepatic segments was higher with 3D first than 2D (77% vs 69%; P = 0.05) and not significantly improved by a combination of 3D and 2D. Increased confidence in segment identification was highest in trainees after 3D (P = 0.04). Discussion 3D-printed models facilitate learning hepatic segmental anatomy.