Citations

AbstractAlthough pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

AbstractObjectiveDisparities in tobacco use persist despite successful policies reducing use within the United States. In particular, the prevalence of tobacco use in rural and certain minority communities is significantly higher compared to that of their counterparts. In this work, we examine the impact of rurality, mental health, and racial discrimination on tobacco use.MethodsData come from the 2003 California Health Interview Survey (n = 42,044). Modified Poisson regression models were adjusted for age, sex, race/ethnicity, birth origin, education, income, insurance, and marital status.ResultsCompared to urban residents, rural residents had a significantly higher risk for smoking after adjustment (RR = 1.10, 95% CI: 1.01‐1.19). Those who reported having experienced racial discrimination also had a significantly greater risk for smoking compared to those who did not (RR = 1.17, 95% CI: 1.07‐1.27). Additionally, those who reported higher stress had a significantly greater risk for smoking (RR = 1.61, 95% CI: 1.07‐1.67). There was evidence of interaction between rurality and race/ethnicity, and rurality and gender (P < .05).ConclusionResiding in rural areas was associated with an increased risk for smoking, above and beyond sociodemographics. There were no significant differences across rural‐urban environments for the relationship between stress and tobacco use—an indication that the impact of stress and discrimination is not buffered or exacerbated by environmental characteristics potentially found in either location. Mechanisms that explain rural‐urban tobacco use disparities need to be explored, and smoking cessation programs and policies should be tailored to target these factors within rural communities.

Abstract To move beyond a select few genes/drugs, the successful adoption of pharmacogenomics into routine clinical care requires a curated and machine-readable database of pharmacogenomic knowledge suitable for use in an electronic health record (EHR) with clinical decision support (CDS). Recognizing that EHR vendors do not yet provide a standard set of CDS functions for pharmacogenetics, the Clinical Pharmacogenetics Implementation Consortium (CPIC) Informatics Working Group is developing and systematically incorporating a set of EHR-agnostic implementation resources into all CPIC guidelines. These resources illustrate how to integrate pharmacogenomic test results in clinical information systems with CDS to facilitate the use of patient genomic data at the point of care. Based on our collective experience creating existing CPIC resources and implementing pharmacogenomics at our practice sites, we outline principles to define the key features of future knowledge bases and discuss the importance of these knowledge resources for pharmacogenomics and ultimately precision medicine.

Posttraumatic stress disorder (PTSD) has symptoms that exist along a spectrum that includes depression and the 2 disorders may coexist. Collaborative care management (CCM) has been successfully used in outpatient mental health management (especially depression and anxiety) with favorable outcomes. Despite this, there exist limited data on clinical impact of a diagnosis of PTSD on depression outcomes in CCM. The present study used a retrospective cohort design to examine the association of PTSD with depression outcomes among 2121 adult patients involved in CCM in a primary care setting. Using standardized self-report measures, baseline depression scores and 6-month outcome scores were evaluated. Seventy-six patients had a diagnosis of PTSD documented in their electronic medical record. Patients with PTSD reported more severe depressive symptoms at baseline (Patient Health Questionnaire–9 score of 17.9 vs 15.4, P < .001) than those without PTSD. Controlling for sociodemographic and clinical characteristics, a clinical diagnosis of PTSD was associated with lower odds (AOR = 0.457, CI = 0.274-0.760, P = .003) of remission at 6 months and was also associated with higher odds (AOR = 3.112, CI = 1.921-5.041, P < .001) of persistent depressive symptoms at 6 months after CCM. When coexisting with depression, a diagnosis of PTSD was associated with worse depression outcomes, when managed with CCM in primary care. Opportunities still exist for more aggressive management of depression in these patients to help improve remission as well as reduce persistent depressive symptoms.

Abstract Background: End-stage renal disease is a life-limiting illness associated with significant morbidity. Half of all individuals with end-stage renal disease are unable to participate in decision making at the end of life, which makes advance care planning critical in this population. Objective: We sought to determine the feasibility of embedding palliative medicine consultations in the hemodialysis unit during treatment runs and the impact of this intervention on advance care planning and symptom management. Design: Single-center, prospective cohort study. Setting/Subjects: Adults receiving in-center hemodialysis at a single outpatient unit were eligible. All consultations occurred during the patients' hemodialysis runs between January 1 and June 30, 2012. Measurement: Medical records were reviewed for documentation of advance directives, resuscitation status, and goals of care discussions before and after palliative medicine intervention. Symptom surveys with the Modified Edmonton Symptom Assessment Scale (validated for end-stage renal disease) were performed preintervention and postintervention. Results: Ninety-two patients were eligible; 91 underwent palliative medicine consultation. Symptoms were well controlled at baseline prior to any intervention. After palliative medicine consultation, the prevalence of unknown code status decreased from 23% to 1% and goals of care documentation improved from 3% to 59%. Conclusion: Palliative medicine consultation during in-center outpatient hemodialysis was well received by patients and clinical staff. Patients' symptoms were well managed at baseline by the primary nephrology team. The frequency of goals of care documentation and clarification of code status improved significantly. Embedded palliative medicine specialists on the dialysis care team may be effective in improving multidisciplinary patient-centered care for patients with end-stage renal disease.

SummaryThe rituximab extended schedule or retreatment trial (RESORT; E4402) was a phase 3 randomized prospective trial comparing maintenance rituximab (MR) versus a retreatment (RR) dosing strategy in asymptomatic, low tumour burden indolent lymphoma. A planned exploratory sub‐study compared the two strategies for small lymphocytic (SLL) and marginal zone lymphomas (MZL). Patients responding to rituximab weekly × 4 were randomized to MR (single dose rituximab every 3 months until treatment failure) or RR (rituximab weekly × 4) at the time of each progression until treatment failure. The primary endpoint was time to treatment failure (TTTF). Patients with SLL (n = 57), MZL (n = 71) and unclassifiable small B‐cell lymphoma (n = 3) received induction rituximab. The overall response rate (ORR) was 40% [95% confidence interval (CI) 31–49%; SLL ORR 22·8%; MZL ORR 52·1%]; all 52 responders were randomized. At a median of 4·3 years from randomization, treatment failure occurred in 18/23 RR and 15/29 MR. The median TTTF was 1·4 years for RR and 4·8 years for MR (P = 0·012); median time to first cytotoxic therapy was 6·3 years for RR and not reached for MR (P = 0·0002). Survival did not differ (P = 0·72). In low tumour burden SLL and MZL patients responding to rituximab induction, MR significantly improved TTTF as compared with RR.