Exploration of model misspecification in latent class methods for longitudinal data: Correlation structure matters.

Modeling longitudinal trajectories and identifying latent classes of trajectories is of great interest in biomedical research, and software to identify latent classes of such is readily available for latent class trajectory analysis (LCTA), growth mixture modeling (GMM) and covariance pattern mixture models (CPMM). In biomedical applications, the level of within-person correlation is often non-negligible, which can impact the model choice and interpretation. LCTA does not incorporate this correlation. GMM does so through random effects, while CPMM specifies a model for within-class marginal covariance matrix. Previous work has investigated the impact of constraining covariance structures, both within and across classes, in GMMs-an approach often used to solve convergence problems. Using simulation, we focused specifically on how misspecification of the temporal correlation structure and strength, but correct variances, impacts class enumeration and parameter estimation under LCTA and CPMM. We found (1) even in the presence of weak correlation, LCTA often does not reproduce original classes, (2) CPMM performs well in class enumeration when the correct correlation structure is selected, and (3) regardless of misspecification of the correlation structure, both LCTA and CPMM give unbiased estimates of the class trajectory parameters when the within-individual correlation is weak and the number of classes is correctly specified. However, the bias increases markedly when the correlation is moderate for LCTA and when the incorrect correlation structure is used for CPMM. This work highlights the importance of correlation alone in obtaining appropriate model interpretations and provides insight into model choice.

Identification of Trajectory-Based Acute Kidney Injury Phenotypes Among Cardiac Surgery Patients.

BACKGROUND: Acute kidney injury (AKI) is a common and serious complication of cardiac surgical procedures for which unrecognized heterogeneity may underpin poor success in identifying effective therapies. We aimed to identify phenotypically similar groups of patients as defined by their postoperative creatinine trajectories. METHODS: This was a retrospective, single-center cohort study in an academic tertiary care center including patients undergoing coronary artery bypass graft procedures. AKI phenotypes were evaluated through latent class mixed modeling of serum creatinine patterns (trajectories). To identify trajectory phenotypes, modeling was performed using postoperative creatinine values from 50% of patients (development cohort) and for comparison similarly conducted for the remaining sample (validation cohort). Subsequent assessments included comparisons of classes between development and validation cohorts for consistency and stability, and among classes for patient and procedural characteristics, complications, and long-term survival. RESULTS: We identified 12 AKI trajectories in both the development (n = 2647) and validation cohorts (n = 2647). Discrimination among classes was good (mean posterior class membership probability, 66%-88%), with differences in rate, timing, and degree of serum creatinine rise/fall, and recovery. In matched class comparisons between cohorts, many other phenotypic similarities were present. Notably, 4 high-risk phenotypes had greater long-term risk for death relative to lower risk classes. CONCLUSIONS: Latent class mixed modeling identified 12 reproducible AKI classes (serum creatinine trajectory phenotypes), including 4 with higher risk of poor outcome, in patients following coronary artery bypass graft procedures. Such hidden structure offers a novel approach to grouping patients for renoprotection investigations in addition to reanalysis of previously conducted trials.

Preferences for and Experiences of Shared and Informed Decision Making Among Patients Choosing Kidney Replacement Therapies in Nephrology Care.

RATIONALE & OBJECTIVE: Chronic kidney disease (CKD) can progress rapidly, and patients are often unprepared to make kidney failure treatment decisions. We aimed to better understand patients' preferences for and experiences of shared and informed decision making (SDM) regarding kidney replacement therapy before kidney failure. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: Adults receiving nephrology care at CKD clinics in rural Pennsylvania. PREDICTORS: Estimated glomerular filtration rate, 2-year risk for kidney failure, duration and frequency of nephrology care, and preference for SDM. OUTCOMES: Occurrence and extent of kidney replacement therapy discussions and participants' satisfaction with those discussions. ANALYTIC APPROACH: Multivariable logistic regression to quantify associations between participants' characteristics and whether they had discussions. RESULTS: The 447 study participants had a median age of 72 (IQR, 64-80) years and mean estimated glomerular filtration rate of 33 (SD, 12) mL/min/1.73 m2. Most (96%) were White, high school educated (67%), and retired (65%). Most (72%) participants preferred a shared approach to kidney treatment decision making, and only 35% discussed dialysis or transplantation with their kidney teams. Participants who had discussions (n = 158) were often completely satisfied (63%) but infrequently discussed potential treatment-related impacts on their lives. In multivariable analyses, those with a high risk for kidney failure within 2 years (OR, 3.24 [95% CI, 1.72-6.11]; P < 0.01), longer-term nephrology care (OR, 1.12 [95% CI, 1.05-1.20] per 1 additional year; P < 0.01), and more nephrology visits in the prior 2 years (OR, 1.34 [95% CI, 1.20-1.51] per 1 additional visit; P < 0.01) had higher odds of having discussed dialysis or transplantation. LIMITATIONS: Single health system study. CONCLUSIONS: Most patients preferred sharing CKD treatment decisions with their providers, but treatment discussions were infrequent and often did not address key treatment impacts. Longitudinal nephrology care and frequent visits may help ensure that patients have optimal SDM experiences.

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study.

RATIONALE & OBJECTIVE: Digital health system tools to support shared decision making and preparation for kidney replacement treatments for patients with chronic kidney disease (CKD) are needed. STUDY DESIGN: Descriptive study of the implementation of digital infrastructure to support a patient-centered health system intervention. SETTING & PARTICIPANTS: 4 CKD clinics within a large integrated health system. EXPOSURE: We developed an integrated suite of digital engagement tools to support patients' shared decision making and preparation for kidney failure treatments. Tools included an automated CKD patient registry and risk prediction algorithm within the electronic health record (EHR) to identify and prioritize patients in need of nurse case management to facilitate shared decision making and preparation for kidney replacement treatments, an electronic patient-facing values clarification tool, a tracking application to document patients' preparation for treatments, and an EHR work flow to broadcast patients' treatment preferences to all health care providers. OUTCOMES: Uptake and acceptability. ANALYTIC APPROACH: Mixed methods. RESULTS: From July 1, 2017, through June 30, 2018, the CKD registry identified 1,032 patients in 4 nephrology clinics, of whom 243 (24%) were identified as high risk for progressing to kidney failure within 2 years. Kidney Transitions Specialists enrolled 117 (48%) high-risk patients by the end of year 1. The values tool was completed by 30/33 (91%) patients who attended kidney modality education. Nurse case managers used the tracking application for 100% of patients to document 287 planning steps for kidney replacement therapy. Most (87%) high-risk patients had their preferred kidney replacement modality documented and displayed in the EHR. Nurse case managers reported that the tools facilitated their identification of patients needing support and their navigation activities. LIMITATIONS: Single institution, short duration. CONCLUSIONS: Digital health system tools facilitated rapid identification of patients needing shared and informed decision making and their preparation for kidney replacement treatments. FUNDING: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (IHS-1409-20967). TRIAL REGISTRATION: ClinicalTrials.gov NCT02722382.

Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access.

Background: Guidelines recommend pre-emptive creation of arteriovenous (AV) access. However, <20% of US patients initiate hemodialysis (HD) with a functional AV access. We implemented a quality improvement (QI) program to improve pre-HD vascular access care. Methods: After conducting qualitative research with key informants, we implemented a 7-month vascular access support QI program at Geisinger Health. The program targeted patient and health system barriers to AV access through education, needs assessment, peer support, care navigation, and electronic supports. We performed pre-, intra-, and postprogram stakeholder interviews to identify program barriers and facilitators and to assess acceptability. In a research substudy, we compared pre- and postprogram self-efficacy, knowledge, and confidence navigating vascular access care. Results: There were 37 patient and 32 clinician/personnel participants. Of the 37 patients, 34 (92%) completed vascular access-specific education, 33 (89%) underwent needs assessment, eight (22%) engaged with peer mentors, 21 (57%) had vein mapping, 18 (49%) had an initial surgical appointment, 15 (40%) underwent AV access surgery, and six (16%) started HD during the 7-month program. Qualitative findings demonstrated program acceptability to participants and suggested that education provision and emotional barrier identification were important to engaging patients in vascular access care. Research findings showed pre- to postprogram improvements in patient self-efficacy (28.1-30.8, P=0.05) and knowledge (4.9-6.9, P=0.004), and trends toward improvements in confidence among patients (8.0-8.7, P=0.2) and providers (7.5-7.8, P=0.1). Conclusions: Our intervention targeting patient and health system barriers improved patient vascular access knowledge and self-efficacy. Clinical Trial registry name and registration number: Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation, NCT04032613.

Transplant social worker and donor financial assistance to increase living donor kidney transplants among African Americans: The TALKS Study, a randomized comparative effectiveness trial.

Lack of donors hinders living donor kidney transplantation (LDKT) for African Americans. We studied the effectiveness of a transplant social worker intervention (TALK SWI) alone or paired with living donor financial assistance to activate African Americans' potential living kidney donors. African Americans (N = 300) on the transplant waiting list were randomly assigned to usual care; TALK SWI; or TALK SWI plus Living Donor Financial Assistance. We quantified differences in live kidney donor activation (composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) after 12 months. Participants' mean age was 52 years, 56% were male, and 43% had annual household income less than $40,000. Most previously pursued LDKT. Participants were highly satisfied with TALK social workers, but they rarely utilized Financial Assistance. After 12 months, few (n = 39, 13%) participants had a new donor activation event (35 [12%] new donor inquiries; 17 [6%] new donor evaluations; 4 [1%] LDKT). There were no group differences in donor activation events (subdistribution hazard ratio [95% CI]: 1.09 [0.51-2.30] for TALK SWI and 0.92 [0.42-2.02] for TALK SWI plus Financial Assistance compared to Usual Care, p = 91). Alternative interventions to increase LDKT for African Americans on the waiting list may be needed. Trial registration: ClinicalTrials.gov (NCT02369354).

Advanced CKD Care and Decision Making: Which Health Care Professionals Do Patients Rely on for CKD Treatment and Advice?

RATIONALE & OBJECTIVE: Chronic kidney disease (CKD) care is often fragmented across multiple health care providers. It is unclear whether patients rely mostly on their nephrologists or non-nephrologist providers for medical care, including CKD treatment and advice. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: Adults receiving nephrology care at CKD clinics in Pennsylvania. PREDICTORS: Frequency, duration, and patient-centeredness (range, 1 [least] to 4 [most]) of participants' nephrology care. OUTCOME: Participants' reliance on nephrologists, primary care providers, or other specialists for medical care, including CKD treatment and advice. ANALYTICAL APPROACH: Multivariable logistic regression to quantify associations between participants' reliance on their nephrologists (vs other providers) and their demographics, comorbid conditions, kidney function, and nephrology care. RESULTS: Among 1,412 patients in clinics targeted for the study, 676 (48%) participated. Among these, 453 (67%) were eligible for this analysis. Mean age was 71 (SD, 12) years, 59% were women, 97% were white, and 65% were retired. Participants were in nephrology care for a median of 3.8 (IQR, 2.0-6.6) years and completed a median of 4 (IQR, 3-5) nephrology appointments in the past 2 years. Half (56%) the participants relied primarily on their nephrologists, while 23% relied on primary care providers, 18% relied on all providers equally, and 3% relied on other specialists. Participants' adjusted odds of relying on their nephrologists were higher for those in nephrology care for longer (OR, 1.08 [95% CI, 1.02-1.15]; P = 0.02), those who completed more nephrology visits in the previous 2 years (OR, 1.16 [95% CI, 1.05-1.29]; P = 0.005), and those who perceived their last interaction with their nephrologists as more patient-centered (OR, 2.63 [95% CI, 1.70-4.09]; P < 0.001). LIMITATIONS: Single health system study. CONCLUSIONS: Many nephrology patients relied on non-nephrologist providers for medical care. Longitudinal patient-centered nephrology care may encourage more patients to follow nephrologists' recommendations.

Associations of perceived information adequacy and knowledge with pursuit of live donor kidney transplants and living donor inquiries among African American transplant candidates.

We studied associations between perceived adequacy of live donor kidney transplant (LDKT) information or knowledge with pursuit of LDKT or receipt of live donor inquiries among 300 African American kidney transplant candidates. Participants reported via questionnaire how informed or knowledgeable they felt regarding LDKT. Participants also reported their pursuit of LDKT, categorized as "low" (no discussion with family or friends about LDKT and no identified donor), "intermediate" (discussed LDKT with family but no identified donor) or "high" (discussed LDKT with family and identified a potential donor). We reviewed participants' electronic health records to identify potential donors' transplant center inquiries on participants' behalves. A minority of participants reported they felt "very" or "extremely" well informed about LDKT (39%) or had "a great deal" of LDKT knowledge (38%). Participants perceiving themselves as "very" or "extremely" (vs "not" or "slightly") well informed about LDKT had statistically significantly greater odds of intermediate or high (vs low) pursuit of LDKT (odds ratio [95% confidence interval] 2.71 [1.02-7.17]). Perceived LDKT knowledge was not associated with pursuit of LDKT. Neither perceived information adequacy nor knowledge was associated with living donor inquiries. Efforts to better understand the role of education in the pursuit of LDKT among African American transplant candidates are needed.

Hypertension Self-management in Socially Disadvantaged African Americans: the Achieving Blood Pressure Control Together (ACT) Randomized Comparative Effectiveness Trial.

BACKGROUND: Effective hypertension self-management interventions are needed for socially disadvantaged African Americans, who have poorer blood pressure (BP) control compared to others. OBJECTIVE: We studied the incremental effectiveness of contextually adapted hypertension self-management interventions among socially disadvantaged African Americans. DESIGN: Randomized comparative effectiveness trial. PARTICIPANTS: One hundred fifty-nine African Americans at an urban primary care clinic. INTERVENTIONS: Participants were randomly assigned to receive (1) a community health worker ("CHW") intervention, including the provision of a home BP monitor; (2) the CHW plus additional training in shared decision-making skills ("DoMyPART"); or (3) the CHW plus additional training in self-management problem-solving ("Problem Solving"). MAIN MEASURES: We assessed group differences in BP control (systolic BP (SBP) < 140 mm Hg and diastolic BP (DBP) < 90 mmHg), over 12 months using generalized linear mixed models. We also assessed changes in SBP and DBP and participants' BP self-monitoring frequency, clinic visit patient-centeredness (i.e., extent of patient-physician discussions focused on patient emotional and psychosocial concerns), hypertension self-management behaviors, and self-efficacy. KEY RESULTS: BP control improved in all groups from baseline (36%) to 12 months (52%) with significant declines in SBP (estimated mean [95% CI] - 9.1 [- 15.1, - 3.1], - 7.4 [- 13.4, - 1.4], and - 11.3 [- 17.2, - 5.3] mmHg) and DBP (- 4.8 [- 8.3, - 1.3], - 4.0 [- 7.5, - 0.5], and - 5.4 [- 8.8, - 1.9] mmHg) for CHW, DoMyPART, and Problem Solving, respectively). There were no group differences in BP outcomes, BP self-monitor use, or clinic visit patient-centeredness. The Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 18.7 [4.0, 87.3]) and self-efficacy scores (OR [95% CI] 4.7 [1.5, 14.9]) at 12 months compared to baseline, while other groups did not. Compared to DoMyPART, the Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 5.7 [1.3, 25.5]) at 12 months. CONCLUSION: A context-adapted CHW intervention was correlated with improvements in BP control among socially disadvantaged African Americans. However, it is not clear whether improvements were the result of this intervention. Neither the addition of shared decision-making nor problem-solving self-management training to the CHW intervention further improved BP control. TRIAL REGISTRY: ClinicalTrials.gov Identifier: NCT01902719.

Smoking Status and Survival Among a National Cohort of Lung and Colorectal Cancer Patients.

INTRODUCTION: The purpose of this study was to explore the association of smoking status and clinically relevant duration of smoking cessation with long-term survival after lung cancer (LC) or colorectal cancer (CRC) diagnosis. We compared survival of patients with LC and CRC who were never-smokers, long-term, medium-term, and short-term quitters, and current smokers around diagnosis. METHODS: We studied 5575 patients in Cancer Care Outcomes Research and Surveillance (CanCORS), a national, prospective observational cohort study, who provided smoking status information approximately 5 months after LC or CRC diagnosis. Smoking status was categorized as: never-smoker, quit >5 years prior to diagnosis, quit between 1-5 years prior to diagnosis, quit less than 1 year before diagnosis, and current smoker. We examined the relationship between smoking status around diagnosis with mortality using Cox regression models. RESULTS: Among participants with LC, never-smokers had lower mortality risk compared with current smokers (HR 0.71, 95% CI 0.57 to 0.89). Among participants with CRC, never-smokers had a lower mortality risk as compared to current smokers (HR 0.79, 95% CI 0.64 to 0.99). CONCLUSIONS: Among both LC and CRC patients, current smokers at diagnosis have higher mortality than never-smokers. This effect should be further studied in the context of tumor biology. However, smoking cessation around the time of diagnosis did not affect survival in this sample. IMPLICATIONS: The results from our analysis of patients in the CanCORS consortium, a large, geographically diverse cohort, show that both LC and CRC patients who were actively smoking at diagnosis have worse survival as compared to never-smokers. While current smoking is detrimental to survival, cessation upon diagnosis may not mitigate this risk.

Self-reported Physical Function Decline and Mortality in Older Adults Receiving Hemodialysis.

RATIONALE & OBJECTIVE: Timely recognition of functional decline in older adults receiving dialysis will allow clinicians to pursue interventions to prevent further disability and/or lead patient-centered goals of care discussions. Annual change in the 12-Item Short Form Health Survey (SF-12) physical component score (PCS) could identify patients with functional decline. Our objectives were to assess SF-12 PCS change over a year, risk factors associated with SF-12 PCS change, and the association of SF-12 PCS change with mortality in a survivor cohort of older adults receiving dialysis. STUDY DESIGN: Retrospective study. SETTING & PARTICIPANTS: 1,371 adults 65 years or older receiving hemodialysis for 6 or more months who completed SF-12 PCSs 300 or more days apart from 2012 to 2013. EXPOSURES: Serum albumin level; hemodialysis access type; SF-12 PCS change (for mortality analyses). OUTCOMES: SF-12 PCS change and mortality. ANALYTICAL APPROACH: Multivariable-adjusted linear regression model; Cox proportional hazards model. RESULTS: We excluded 24% (n = 801) of our cohort for death before the second SF-12 PCS. Among the 1,371 with sufficient SF-12 PCS data, mean age was 79.9 ± 4.5 years. Average SF-12 PCS change in 1 year was minimal (-0.9 ± 9.6), but 39.3% (n = 539) and 32.2% (n = 442) had clinically relevant SF-12 PCS decline and improvement, respectively. Albumin level and access type were not statistically associated with SF-12 PCS change. SF-12 PCS change was not associated with mortality (adjusted HR, 0.98; 95% CI, 0.96-1.00). LIMITATIONS: 2 time points to assess SF-12 PCS change; covariate assessment only at baseline; survivor bias. CONCLUSIONS: In this cohort of older adults receiving hemodialysis, nearly one-fourth died, while among survivors, it was more common for SF-12 PCS to decline than improve in a year. Annual SF-12 PCS change was not associated with traditional risk factors for functional impairment or mortality risk. Additional research is needed to identify appropriate measures and frequency of assessment for functional decline.

Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial.

Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This manuscript describes the study protocol, recruitment, and baseline participant characteristics for the Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study. The STOP-DKD study is a randomized controlled trial designed to evaluate the effectiveness of a multifactorial behavioral and medication management intervention to mitigate kidney function decline at 3 years compared to usual care. The intervention consists of up to 36 monthly educational modules delivered via telephone by a study pharmacist, home blood pressure monitoring, and medication management recommendations delivered electronically to primary care physicians. Patients seen at seven primary care clinics in North Carolina, with diabetes and [1] uncontrolled hypertension and [2] evidence of kidney dysfunction (albuminuria or reduced estimated glomerular filtration rate [eGFR]) were eligible to participate. Study recruitment completed in December 2014. Of the 281 participants randomized, mean age at baseline was 61.9; 52% were male, 56% were Black, and most were high school graduates (89%). Baseline co-morbidity was high- mean blood pressure was 134/76 mmHg, mean body mass index was 35.7 kg/m2, mean eGFR was 80.7 ml/min/1.73 m2, and mean glycated hemoglobin was 8.0%. Experiences of recruiting and implementing a comprehensive DKD program to individuals at high risk seen in the primary care setting are provided. TRIAL REGISTRATION: NCT01829256.

12-month trajectories of depressive symptoms among nurses-Contribution of personality, job characteristics, coping, and burnout.

BACKGROUND: Job related factors have been associated with higher risk for developing depression, but past studies lacked full consideration of individual factors such as personality and coping. We sought to evaluate associations of personality, coping, job characteristics, and burnout with 12-month trajectories of depressive symptoms among nursing workers. METHODS: Cohort of nursing workers (N = 281) in a private hospital system, with baseline assessments of personality, job characteristics, and coping. Burnout and depression were measured at baseline and during monthly follow-ups. Linear mixed modeling was used to examine contributions to between- and within-individual variation in monthly depressive symptoms. RESULTS: Personality trait of negative affectivity accounted for 36% of between-individual variation in depressive symptoms over 12 months, while job characteristics and coping explained an additional 5% and 8% of this variation, respectively. Exhaustion dimension of burnout was associated with between-individual variation in depressive symptoms (fixed effect ß coefficient 2.44, p < 0.001), but not with within-individual variation in symptoms. Disengagement dimension of burnout was not associated with between-individual variation in depressive symptoms, but contributed to within-individual variation in depressive symptoms over time (fixed effect ß coefficient 0.52, p = 0.01). LIMITATIONS: Participants were nursing workers within a single hospital system. Participants who were excluded due to missing baseline data were more likely of non-white race, which may also limit the generalizability of our results. We used latent variables to represent certain job and coping characteristics, which may make our results less comparable with other studies examining the role of these factors in work-associated depression. CONCLUSIONS: Future interventions to prevent depression in healthcare workers should consider multiple job and individual factors. Potential components include strategies to manage negative affectivity and reduce avoidant coping, such as cognitive reframing and mindfulness-based techniques, and organizational approaches to address burnout through augmentation of job resources.

Racial differences in nocturnal dipping status in diabetic kidney disease: Results from the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) study.

While racial variation in ambulatory blood pressure (BP) is known, patterns of diurnal dipping in the context of diabetic kidney disease have not been well defined. The authors sought to determine the association of race with nocturnal dipping status among participants with diabetic kidney disease enrolled in the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) trial. The primary outcome was nocturnal dipping-percent decrease in average systolic BP from wake to sleep-with categories defined as reverse dippers (decrease <0%), nondippers (0%-<10%), and dippers (≥10%). Twenty-four-hour ambulatory BP monitoring was completed by 108 participants (54% were nondippers, 24% were dippers, and 22% were reverse dippers). In adjusted models, the common odds of reverse dippers vs nondippers/dippers and reverse dippers/nondippers vs dippers was 2.6 (95% confidence interval, 1.2-5.8) times higher in blacks than in whites. Without ambulatory BP monitoring data, interventions that target BP in black patients may be unable to improve outcomes in this high-risk group.

Physical resilience of older cancer survivors: An emerging concept.

OBJECTIVES: To characterize factors contributing to physical resilience in older cancer survivors, as demonstrated by resistance to decline or recovery (resilience). MATERIALS AND METHODS: We conducted a secondary analysis of data from a randomized controlled trial of cancer survivors ≥65years old and ≥5years from cancer diagnoses. Physical function was assessed quarterly over 2years, with Short-Form 36 physical function subscale. Participants with ≥2 follow-up assessments (n=594) were evaluated for physical resilience: 1) Resistance was defined as lack of any decline, where decline was a drop of ≥13 points, and 2) resilience (i.e., recovery) was defined as regaining ≥50% of lost function, subsequent to decline. RESULTS: Mean age was 73.1years and 89.1% were Caucasian. Forty-nine percent (n=289) were resistant to decline in function; these individuals were younger, had higher education and income, were more likely to be Caucasian, and had higher baseline physical function (mean difference [MD] 7.8 points, 95% CI 5.0-10.8) and general health (MD 7.5 points, 95% CI 4.9-10.1). Fifty-seven percent (n=137 of 239) demonstrated resilience, with 91.2% (n=125) recovering within 6months of declines; these participants had higher baseline physical function (MD 6.6 points, 95% CI 1.8-11.4), but similar pre-decline function. More participants who were resistant, and more who showed resilience, reported high self-efficacy and social support. CONCLUSIONS: The majority of older cancer survivors exhibited physical resilience; this was associated with high baseline health, physical function, self-efficacy, and social support. Assessing and targeting psychosocial factors may be important for interventions seeking to promote physical resilience.

Effect of Clinical and Attitudinal Characteristics on Obtaining Comprehensive Medication Reviews.

BACKGROUND: Comprehensive medication reviews (CMRs) consist of in-depth reviews of patients' medications to identify effectiveness or safety problems and often generate cost savings for individuals. Despite their advantages, CMRs are not widely obtained. Previous studies found that older age, female sex, and experience of side effects were associated with obtaining a medication review. OBJECTIVE: To quantify the association between attitudinal and clinical factors with intention and predict future behavior to obtain a CMR among Medicare Part D beneficiaries. METHODS: A sample of Medicare Part D beneficiaries from 1 health care plan (n = 660) completed a 14-item survey over the telephone assessing factors that were hypothesized to affect their intention and behavior to obtain a CMR. The survey collected medication use history and health care information with the medication user self-evaluation tool, health status, adherence, intention to obtain a CMR, and demographic characteristics. Subjects subsequently were informed that they could obtain a CMR from their pharmacies. Claims data were obtained that indicated which subjects received a CMR. Two dependent variables were predicted: intention to schedule a CMR using a multivariate linear regression model and receipt of a CMR using a logistic regression and including intention as a predictor variable. RESULTS: The mean age of participants was 76.6 (SD = 7.61) years; 71% were female; and participants took an average of 5.2 (SD = 3.18) medications. The intention to have a CMR was 2.85 (SD = 1.41) on a 5-point scale, and 5.6% of the participants actually had a CMR. Worrying about medications doing more harm than good, number of pharmacies where participants obtained their medications from, number of medications, and number of medical conditions predicted intention to obtain a CMR. Patients who perceived their health status to be poorer compared with others their age were more likely to have a CMR. Intention to obtain a CMR was not associated with receipt of a CMR. CONCLUSIONS: Stakeholders should target patients who perceive their health to be poor for a CMR, hence expanding the scope of CMRs and increasing the number of older adults benefiting from this service. DISCLOSURES: This study was funded by a grant from the Agency for Healthcare Research and Quality (1R18HS018353). Frank is an employee of Outcomes MTM. Pendergast has received grants from the NIH, NIA, and PICORI. Farris has received grants from NIH and speaker fees from Chulalongkorn University, Bangkok, Thailand, and the American College of Clinical Pharmacy. All other authors declare that they have no conflicts of interest. Study concept was developed by Farris, Pendergast, Chrischilles, and Doucette. Pendergast, Frank, Farris, and Aneese collected the data, with assistance from Chrischilles and Doucette. Data interpretation was performed by Farris, Marshall, Salgado, and Aneese, with assistance from the other authors. The manuscript was written by Farris, Salgado, and Aneese, with assistance from the other authors, and revised by Salgado and Marshall, assisted by the other authors.

The Effect of Receiving Treatment Within a Clinical Trial Setting on Survival and Quality of Care Perception in Advanced Stage Non-Small Cell Lung Cancer.

OBJECTIVES: Treatment outcomes of advanced stage (IIIB and IV) non-small cell lung cancer (NSCLC) are poor. In this study, we explore the survival outcomes and the perception of the quality of care delivered in stage IIIB and IV NSCLC patients treated within versus outside a clinical trial. MATERIALS AND METHODS: Data were obtained from the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS). Baseline characteristics according to clinical trial participation were determined. The association between clinical trial enrollment and survival was assessed using a Cox proportional hazard model after adjusting for age, income, primary data collection and research site, comorbidities, self-reported performance status, presence of brain metastasis, stage IIIB versus IV, and cancer histology. RESULTS: Of 815 stage IIIB and IV NSCLC patients, 56 (7%) were enrolled in clinical trials. Median survival for the patients treated within versus outside a clinical trial was 20.5 versus 16.7 months, respectively (P=0.21). Using a multivariate survival model, clinical trial enrollment did not correlate with longer survival (P=0.81). Comparing patients according to clinical trial enrollment, patients treated within a clinical trial setting perceived a better overall quality of care (P<0.01). CONCLUSIONS: Management of stage IIIB and IV NSCLC patients within a clinical trial setting conveyed a perception of superior care that did not translate into survival benefit. These findings suggest that providing cancer care within a clinical trial should not imply a survival benefit when counseling stage IIIB and IV NSCLC patients about entering clinical trials.

Stimulating comprehensive medication reviews among Medicare Part D beneficiaries.

OBJECTIVES: To assess the impact of a patient engagement intervention utilizing the Medication User Self-Evaluation (MUSE) tool on the completion percentage of comprehensive medication reviews (CMRs) among Medicare Part D beneficiaries. STUDY DESIGN: A case-control study. METHODS: Beneficiaries from 2 Medicare Part D plans were randomly assigned to 3 study arms (1 control arm plus 2 intervention arms for 2011 and 2012, respectively). Each beneficiary who participated in the MUSE intervention met 3 inclusion criteria and was matched with a single control group beneficiary based on: gender; age (within 5-year interval); plan type (ie, Medicare Prescription Drug Plan, Medicare Advantage Prescription Drug Plan); number of unique prescriptions; pharmacy medication therapy management (MTM) training status; and time period (2011, 2012). The outcome of interest was whether or not the beneficiary received a CMR in the 6 months following the index date. Generalized estimating equation (GEE) models were used to compare CMR percentages over time and between MUSE intervention groups. This study used MTM service claims data. RESULTS: The final sample of 1015 beneficiaries received MUSE intervention, of which 1007 were successfully matched to a control beneficiary. The estimated odds of having a CMR among those who received the MUSE intervention were 2 times that of their counterparts (P = .0048) across both study years. CONCLUSIONS: Given the strong evidence found for a positive association between participation in a CMR and the MUSE intervention, Part D plans could use the MUSE to engage targeted beneficiaries in using pharmacist-provided MTM services.

Predictors of Long-Term Quality of Life for Survivors of Stage II/III Rectal Cancer in the Cancer Care Outcomes Research and Surveillance Consortium.

PURPOSE: Many patients do not receive guideline-recommended neoadjuvant chemoradiotherapy for resectable rectal cancer. Little is known regarding long-term quality of life (QOL) associated with various treatment approaches. Our objective was to determine patient characteristics and subsequent QOL associated with treatment approach. METHODS: Our study was a geographically diverse population- and health system-based cohort study that included adults age 21 years or older with newly diagnosed stage II/III rectal cancer who were recruited from 2003 to 2005. Eligible patients were contacted 1 to 4 months after diagnosis and asked to participate in a telephone survey and to consent to medical record review, with separate follow-up QOL surveys conducted 1 and 7 years after diagnosis. RESULTS: Two hundred thirty-nine patients with stage II/III rectal cancer were included in this analysis. Younger age (< 65 v ≥ 65 years: odds ratio, 2.49; 95% CI, 1.33 to 4.65) was significantly associated with increased odds of receiving neoadjuvant or adjuvant chemoradiotherapy. The adjuvant chemoradiotherapy group had significantly worse mean EuroQol-5D (range, 0 to 1) and Short Form-12 physical health component scores (standardized mean, 50) at 1-year follow-up than the neoadjuvant chemoradiotherapy group (0.75 v 0.85; P = .002; 37.2 v 43.3; P = .01, respectively) and the group that received only one or neither form of treatment (0.75 v 0.85; P = .02; 37.2 v 45.1; P = .008, respectively). CONCLUSION: Neoadjuvant treatment may result in better QOL and functional status 1 year after diagnosis. Further evaluation of patient and provider reasons for not pursuing neoadjuvant therapy is necessary to determine how and where to target process improvement and/or education efforts to ensure that patients have access to recommended treatment options.

Factors affecting Medicare Part D beneficiaries' decision to receive comprehensive medication reviews.

OBJECTIVES: To identify factors influencing Medicare Part D beneficiaries' decision to receive pharmacist-provided comprehensive medication reviews (CMRs) and to evaluate their experiences with pharmacist-provided CMRs. DESIGN: Cross-sectional descriptive study. SETTING: Beneficiaries living in Maryland or Minnesota, from November 2011 to January 2012. PARTICIPANTS: Medicare beneficiaries of two Medicare Part D plans who had completed a previous telephone interview for a larger project of medication therapy management quality improvement. INTERVENTION: Self-reported mail survey. MAIN OUTCOME MEASURES: Responses to survey items assessing beneficiaries' perceived importance of proposed factors affecting their decision to receive CMRs and items evaluating patients' experiences with pharmacist-provided CMRs if they had one in the previous year. RESULTS: The valid response rate was 33.4% (238 of 713). Among the proposed factors, "knowing the out-of-pocket cost" (4.12 ± 1.28 [mean ± SD]) and "conducting in the usual pharmacy" (4.01 ± 1.37) were most important in making a decision to get a CMR. Factors rated significantly more important by those who had versus had not received a CMR included "usual pharmacy," "receiving medication list," "physician's support," and "pharmacists discuss changes with physicians." About one-third (30.6%) of respondents reported having pharmacist-provided CMRs within the previous year. Most respondents believed that having CMRs was important for their health (90.6%) and were satisfied with the results of CMRs (94.7%). CONCLUSION: Patients preferred their usual pharmacy or convenient places to have a CMR. Also, a collaborative pharmacist-physician working relationship would be helpful in providing CMRs. Patients who received CMRs expressed a positive attitude toward and satisfaction with pharmacist-provided services.