Cross Disciplinary Role Agreement is Needed When Coordinating Long-Term Opioid Prescribing for Cancer: a Qualitative Study.

BACKGROUND: Cancer pain is highly prevalent and often managed in primary care or by oncology providers in combination with primary care providers. OBJECTIVES: To understand interdisciplinary provider experiences coordinating opioid pain management for patients with chronic cancer-related pain in a large integrated healthcare system. DESIGN: Qualitative research. PARTICIPANTS: We conducted 20 semi-structured interviews with interdisciplinary providers in two large academically affiliated VA Medical Centers and their associated community-based outpatient clinics. Participants included primary care providers (PCPs) and oncology-based personnel (OBPs). APPROACH: We deductively identified 94 examples of care coordination for cancer pain in the 20 interviews. We secondarily used an inductive open coding approach and identified themes through constant comparison coming to research team consensus. RESULTS: Theme 1: PCPs and OBPs generally believed one provider should handle all opioid prescribing for a specific patient, but did not always agree on who that prescriber should be in the context of cancer pain. Theme 2: There are special circumstances where having multiple prescribers is appropriate (e.g., a pain crisis). Theme 3: A collaborative process to opioid cancer pain management would include real-time communication and negotiation between PCPs and oncology around who will handle opioid prescribing. Theme 4: Providers identified multiple barriers in coordinating cancer pain management across disciplines. CONCLUSIONS: Our findings highlight how real-time negotiation about roles in opioid pain management is needed between interdisciplinary clinicians. Lack of cross-disciplinary role agreement may result in delays in clinically appropriate cancer pain management.

Bivalent engagement of endothelial surface antigens is critical to prolonged surface targeting and protein delivery in vivo.

Targeted drug delivery to the endothelium has the potential to generate localized therapeutic effects at the blood-tissue interface. For some therapeutic cargoes, it is essential to maintain contact with the bloodstream to exert protective effects. The pharmacokinetics (PK) of endothelial surface-targeted affinity ligands and biotherapeutic cargo remain a largely unexplored area, despite obvious translational implications for this strategy. To bridge this gap, we site-specifically radiolabeled mono- (scFv) and bivalent (mAb) affinity ligands specific for the endothelial cell adhesion molecules, PECAM-1 (CD31) and ICAM-1 (CD54). Radiotracing revealed similar lung biodistribution at 30 minutes post-injection (79.3% ± 4.2% vs 80.4% ± 10.6% ID/g for αICAM and 58.9% ± 3.6% ID/g vs. 47.7% ± 5.8% ID/g for αPECAM mAb vs. scFv), but marked differences in organ residence time, with antibodies demonstrating an order of magnitude greater area under the lung concentration vs. time curve (AUCinf 1698 ± 352 vs. 53.3 ± 7.9 ID/g*hrs for αICAM and 1023 ± 507 vs. 114 ± 37 ID/g*hrs for αPECAM mAb vs scFv). A physiologically based pharmacokinetic model, fit to and validated using these data, indicated contributions from both superior binding characteristics and prolonged circulation time supporting multiple binding-detachment cycles. We tested the ability of each affinity ligand to deliver a prototypical surface cargo, thrombomodulin (TM), using one-to-one protein conjugates. Bivalent mAb-TM was superior to monovalent scFv-TM in both pulmonary targeting and lung residence time (AUCinf 141 ± 3.2 vs 12.4 ± 4.2 ID/g*hrs for ICAM and 188 ± 90 vs 34.7 ± 19.9 ID/g*hrs for PECAM), despite having similar blood PK, indicating that binding strength is more important parameter than the kinetics of binding. To maximize bivalent target engagement, we synthesized an oriented, end-to-end anti-ICAM mAb-TM conjugate and found that this therapeutic had the best lung residence time (AUCinf 253 ± 18 ID/g*hrs) of all TM modalities. These observations have implications not only for the delivery of TM, but also potentially all therapeutics targeted to the endothelial surface.

Cost-sharing for prescriptions of sildenafil and finasteride: a case study in veteran patients.

OBJECTIVE: To evaluate patients willingness to share the costs of 2 medications (often described as "lifestyle medications"): sildenafil for erectile dysfunction and finasteride for hair loss, which are not routinely covered by the Department of Veterans Affairs (VA) healthcare system. STUDY DESIGN: Self-administered, anonymous survey. PATIENTS AND METHODS: Adult men (n = 339) were recruited from waiting rooms for primary care or erectile dysfunction clinic appointments at 2 Los Angeles VA facilities. RESULTS: Participants with self-reported need were analyzed separately for finasteride (primary care patients only) and sildenafil (both primary care and erectile dysfunction clinic patients). The mean age of the participants was 56 and 60 years for the finasteride and sildenafil groups, respectively. Mean annual household income for both groups was under $10,000. Respondents reported a mean willingness to cost-share $4.20 for a 30-day prescription of daily finasteride (VA wholesale cost = $27) and $5.40 for 4 sildenafil pills (VA wholesale cost = $20). In the multivariate analysis, higher income (P = .002) and increasing self-reported need for medication (P = .04) were associated with increased willingness to cost-share for finasteride after controlling for age, race/ethnicity, insured status, comorbid conditions, and type of clinic. In addition, younger age (P = .01) was associated with greater willingness to cost-share for sildenafil. CONCLUSIONS: In this low-income veteran population, patients with a self-reported need for sildenafil and finasteride would be willing to make a higher copayment than the current VA maximum copayment of $2.00 per 30-day prescription, if these medicines were made available.

Physician perceptions of a national formulary.

OBJECTIVE: To assess the perceptions of US Department of Veterans Affairs (VA) physicians regarding effects of a National Formulary (NF) on patient care, access to drugs, physician workload, and resident training approximately 1 year after it was implemented. STUDY DESIGN: Cross-sectional survey. METHODS: A questionnaire was sent to attending physicians working within the VA healthcare system. Participants included general internists (n = 2824), neurologists (n = 238), psychiatrists (n = 997), general surgeons (n = 429), and urologists (n = 152). The response rate was 45%. RESULTS: Most physicians (63%) thought that they could prescribe needed drugs; 65% agreed that patients could obtain needed nonformulary drugs. One third disagreed that access to prescription pharmaceuticals had increased; 29% stated the NF impinged on providing quality care to their own patients, and 21% thought it did so to patients from other VA facilities. Thirty eight percent of physicians perceived the NF to be more restrictive than private sector formularies; 16% thought that the NF diminished the ability to train residents for managed care. Forty percent thought that the NF added to workload. Generalists more often perceived that the NF improved their ability to provide care compared with neurologists (27% vs 18%, P = .046), psychiatrists (27% vs 22%, P = .027), and internal medicine subspecialists (27% vs 18%, P = .001). Physicians with more clinic time were more likely to perceive that the NF increased workload. CONCLUSION: Although differences of opinions among physicians were noted, most responding VA physicians did not perceive that the NF adversely affected patient care, access to pharmaceuticals, physician workload, or resident training.

The long-term safety and efficacy of pramipexole in advanced Parkinson's disease.

Objective: To assess the long-term safety and efficacy of pramipexole in advanced Parkinson's disease over a four year time period.Methods: This study is an open-label extension trial of pramipexole for Parkinson's disease open to patients completing a double-blind placebo controlled safety and efficacy trial of this drug. Three hundred and six patients entered the trial. These patients had moderate to severe PD (stage II-IV Hoehn and Yahr during off time) and were experiencing motor fluctuations. Patients were titrated over a six week period and then entered a maintenance phase which lasted up to 50 months. Patients were evaluated every 3 months using the Unified Parkinson's Disease Rating Scale (UPDRS II, III and IV) and modified Schwab and England scale (S/E).Results: Sixty-four percent (197) of the 306 patients who entered this study completed it. Patients showed steady improvement over the 6 week ascending dose interval when pramipexole was reintroduced into the trial as the open-label study medication. Over the duration of the trial patients slowly returned to their baseline levels. This was true for all measures evaluated except for the UPDRS part IV. On UPDRS part IV patients remained below their baseline score which indicated an improvement for the duration of the study. Patterns similar to the overall scores were seen when the individual components of the UPDRS scale part II for "on" and "off" periods and part III were evaluated. However tremor during "on" periods showed improvement over baseline for the duration of the trial. The most common adverse events secondary to pramipexole occurring in greater than 10% of patients included dyskinesias, asymptomatic orthostatic hypotension, dizziness, insomnia, and hallucinations.Conclusion: Pramipexole was well tolerated for up to 4 years. Pramipexole treatment appeared to show continued efficacy in the treatment of Parkinson's disease for 3 years in this open-label descriptive study. After 3 years there was a gradual return to baseline motor states perhaps suggesting progression of Parkinson's disease.

Using standardized patients to measure quality: evidence from the literature and a prospective study.

BACKGROUND: Use of standardized patients for evaluating the clinical skills of medical students and medical trainees is commonplace. This has encouraged the use of standardized patients to evaluate the quality of physician practice in outpatient settings. However, there may be substantive differences between observing student performance and evaluating whether the provision of care meets defined quality criteria. OBJECTIVES: This study had two primary objectives: (1) to review studies that use standardized patients to evaluate physician performance and (2) to ascertain directly whether standardized patients could be useful in assessing quality of outpatient care. METHODS: A comprehensive literature review of studies that used standardized patients to assess physician performance was conducted. A prospective study that included 20 physicians at two outpatient settings and 27 actor patients assessed quality of care using eight clinical cases divided into five clinical domains, each of which had explicit criteria checklists based on widely accepted guidelines. RESULTS: The literature review identified five important issues: developing scenarios, selecting explicit criteria, standardizing standardized patient training, creating subterfuges, and ensuring reliability and validity of measures. In the study, trained standardized patients were able to assess physician practice accurately for common medical conditions, using proven criteria linked to health outcomes. The detection rate was 3%. There was no performance variation between actors for seven of the eight cases. CONCLUSIONS: Using standardized patients to measure the quality of care is practical and feasible. The major methodological challenge is incorporating observable evidence-based criteria into realistic scripts and objective checklists. The major logistical challenge is obtaining and maintaining undetected entry into physicians' offices.

How well does chart abstraction measure quality? A prospective comparison of standardized patients with the medical record.

PURPOSE: Despite widespread reliance on chart abstraction for quality measurement, concerns persist about its reliability and validity. We prospectively evaluated the validity of chart abstraction by directly comparing it with the gold standard of reports by standardized patients. SUBJECTS AND METHODS: Twenty randomly selected general internal medicine residents and attending faculty physicians at the primary care clinics of two Veterans Affairs Medical Centers blindly evaluated and treated actor-patients (standardized patients) who had one of four common diseases: diabetes, chronic obstructive pulmonary disease, coronary artery disease, or low back pain. Charts from the visits were abstracted using explicit quality criteria; standardized patients completed a checklist containing the same criteria. For each physician, quality was measured for two different cases of the four conditions (a total of 160 physician-patient encounters). We compared chart abstraction with standardized-patient reports for four aspects of the encounter: taking the history, examining the patient, making the diagnosis, and prescribing appropriate treatment. The sensitivity and specificity of chart abstraction were calculated. RESULTS: The mean (+/- SD) chart abstraction score was 54% +/- 9%, substantially less than the mean score on the standardized-patient checklist of 68% +/- 9% (P <0.001). This finding was similar for all four conditions and at both sites. "False positives"-chart-recorded necessary care actions not reported by the standardized patients-resulted in a specificity of only 81%. The overall sensitivity of chart abstraction for necessary care was only 70%. CONCLUSIONS: Chart abstraction underestimates the quality of care for common outpatient general medical conditions when compared with standardized-patient reports. The medical record is neither sensitive nor specific. Quality measurements derived from chart abstraction may have important shortcomings, particularly as the basis for drawing policy conclusions or making management decisions.

Management of malnutrition in the elderly and the appropriate use of commercially manufactured oral nutritional supplements.

The risk of protein calorie malnutrition among the community dwelling elderly is high. If undetected or untreated malnutrition can raise risks of morbidity and mortality. Therefore, improving screening, assessment and treatment of malnutrition, particularly in ambulatory settings that serve the elderly is imperative. The aim of this paper is to briefly detail the diagnostic criteria for protein calorie malnutrition and discuss the special considerations necessary in evaluating risk and causes of malnutrition in the elderly. We conclude with a review of current management options and discuss the cost effectiveness and potential inappropriate use of commercially manufactured oral nutritional supplements.

Assessment of objectives of post-doctoral general dentistry programs in Canada.

Objectives of hospital-based post-doctoral general dentistry programs in Canada were assessed by questionnaire. Seventy percent (14 of 20) of the program directors responded. Educational goals and objectives were assessed in professional skills and practice management, public health and preventive dentistry, oral medicine and pathology, special needs patient care, trauma and emergency care, restorative/prosthodontic care, endodontics, orthodontics/pediatric dentistry, oral surgery, periodontics, pharmacology, and functioning in a hospital. High rankings of proficiency were related to primary care, restorative/prosthodontic, endodontic, and surgical care. Emergency care, sedation, and pharmacology were also ranked highly. Lower rankings of proficiency were reported in orthodontics, aspects of public health dentistry, practice management, and advanced oral and maxiliofacial surgery. When the results of the Canadian survey were compared with those of a survey of US post-doctoral general dentistry programs, substantial similarity was seen. The findings support continuing reciprocity in accreditation standards between the Canadian and American Commissions on Dental Education and Dental Accreditation.

Comparison of vignettes, standardized patients, and chart abstraction: a prospective validation study of 3 methods for measuring quality.

CONTEXT: Better health care quality is a universal goal, yet measuring quality has proven to be difficult and problematic. A central problem has been isolating physician practices from other effects of the health care system. OBJECTIVE: To validate clinical vignettes as a method for measuring the competence of physicians and the quality of their actual practice. DESIGN: Prospective trial conducted in 1997 comparing 3 methods for measuring the quality of care for 4 common outpatient conditions: (1) structured reports by standardized patients (SPs), trained actors who presented unannounced to physicians' clinics (the gold standard); (2) abstraction of medical records for those same visits; and (3) physicians' responses to clinical vignettes that exactly corresponded to the SPs' presentations. Setting Outpatient primary care clinics at 2 Veterans Affairs medical centers. PARTICIPANTS: Ninety-eight (97%) of 101 general internal medicine staff physicians, faculty, and second- and third-year residents consented to be randomized for the study. From this group, 10 physicians at each site were randomly selected for inclusion. MAIN OUTCOME MEASURES: A total of 160 quality scores (8 cases x 20 physicians) were generated for each method using identical explicit criteria based on national guidelines and local expert panels. Scores were defined as the percentage of process criteria correctly met and were compared among the 3 methods. RESULTS: The quality of care, as measured by all 3 methods, ranged from 76.2% (SPs) to 71.0% (vignettes) to 65.6% (chart abstraction). Measuring quality using vignettes consistently produced scores closer to the gold standard of SP scores than using chart abstraction. This pattern was robust when the scores were disaggregated by the 4 conditions (P<.001 to <.05), by case complexity (P<.001), by site (P<.001), and by level of physician training (P values from <.001 to <.05). The pattern persisted, although less dominantly, when we assessed the component domains of the clinical encounter--history, physical examination, diagnosis, and treatment. Vignettes were responsive to expected directions of variation in quality between sites and levels of training. The vignette responses did not appear to be sensitive to physicians' having seen an SP presenting with the same case. CONCLUSIONS: Our data indicate that quality of health care can be measured in an outpatient setting by using clinical vignettes. Vignettes appear to be a valid and comprehensive method that directly focuses on the process of care provided in actual clinical practice. Vignettes show promise as an inexpensive case-mix adjusted method for measuring the quality of care provided by a group of physicians.