Faculty Bibliography

BACKGROUND: In order to generate valid results in RCTs, it is important to collect unbiased data. Behavioral intervention trials are more difficult to blind than pharmacologic trials. In our ongoing behavioral trial, PATRIOT, which aims to prevent foot complications in diabetes through improved self-care, we are intervening both face-to-face as well as remotely. Consequently blinding is more difficult. Here we illustrate the different blinding processes used. METHODS: In the PATRIOT trial, following randomization during the baseline visit, the intervention group receives computer-based education and demonstration on how to use a special foot thermometer. Following that, intervention participants receive a comprehensive intervention that includes regular telephone counseling and tailored mailings. The control group receives health prevention strategies not related to foot care. For this complex intervention, we needed to develop new strategies to maintain blinding at the participant, research assistant (RA), counselor, outcome adjudicator and data analyst levels. We created a "Blinding Tracker" to identify unblinded and blinded staff so that participants pass from unblinded to blinded staff so that only blinded staff collect data. The integrity of the study is maintained by careful monitoring of blinding with any break in blinding being contained. RESULTS: To date, we have enrolled 221 participants. While participants know the arm to which they are randomized, we needed to make sure that the staff collecting data are blinded. Participants are educated throughout the whole study process by the telephone counselors about the importance of blinding using non-scientific descriptions. Though the counselors know their participant's treatment assignment, they do not know their foot photography results and other outcomes. The RA's, who conduct study visits and collect data, are blinded to treatment assignment. To improve efficiency and preserve blinding, we have different RAs for different phases of a participant's progress. Initially, RAs are initially blinded, but by the end of their involvement with a particular subject, when data collection is done, they become unblinded so they can show the educational videos and demonstrate foot thermometer use. However, RA's can also become unblinded prematurely. To date, out of 96 six-month visits, there have been 26 such instances. RAs are subsequently transitioned off a particular subject to be replaced by a blinded RA. We will also control for RA blinding in the analysis. The adjudicators who read the foot photographs to determine outcomes and the statisticians are blinded to treatment assignment. CONCLUSIONS: Novel techniques have been used to achieve and maintain blinding, but it is resource intensive. While conducting complex trials, vigilance and responsiveness are needed. Finally, blinding information should be incorporated in the analysis in order to get the most valid results

LEARNING OBJECTIVE #1: Recognize the clinical features and complications of Lemierre's syndrome. CASE: A healthy 25-year-old male presented with 8 days of progressively worsening sore throat, fever and neck swelling which were unresponsive to 2 outpatient courses of clarithromycin. On presentation, he was febrile, tachycardic, hypotensive, tachypneic and hypoxic. Physical examination was significant for a palpable left-sided neck mass, trismus, and muffled voice. Initial labs revealed a white blood cell count of 26k, creatinine of 1.9mg/dL, and serum lactate of 4.5mg/dL. The patient was intubated for airway protection, and started on antibiotics and vasopressors. Ultrasound and CT imaging revealed left tonsillar, peritonsillar, and sublingual abscesses, pulmonary septic emboli, bilateral parapneumonic effusions and left internal jugular (IJ) thrombus. Wound cultures of left tonsillar abscess grew Fusobacterium necrophorum and antibiotics were narrowed to piperacillin-tazobactam. He underwent left IJ ligation and left lower lobe lobectomy, and gradually improved and was discharged home on a prolonged course of antibiotics. IMPACT: Lemierre's syndrome is a potentially fatal disease that can cause rapid decompensation if untreated. When a young adult presents with worsening symptoms of acute pharyngitis, one must have a high suspicion for this disease in order to diagnose and treat it early. DISCUSSION: Lemierre's syndrome is a rare and serious disease entity that primarily affects healthy young adults with an incidence of 1 in 1 million and a mortality rate of 4-12%. It involves oropharyngeal fusobacteriuminfection that can form abscesses and internal jugular thrombophlebitis. IJ thrombophlebitis results in bacteremia with septic emboli, commonly to the lungs and joints. The prevalence of Lemierre's syndrome has been rising in recent years due to more judicious use of antibiotics for acute pharyngitis.2 This is also attributed to rising resistance of fusobacterium to macrolides that are often prescribed for pharyngitis, as illustrated by our patient who was initially treated with clarithromycin

LEARNING OBJECTIVE #1: Recognize the clinical presentation and physical exam findings of chronic tophaceous gout LEARNING OBJECTIVE #2: Discuss the management and complications of tophaceous gout CASE: A 40 year-old man with no past medical history presented with 8 months of worsening pain and deforming growths in multiple joints. He first noticed intermittent pain and swelling in the heels of both feet 2 years prior to admission, which progressed to constant pain in his feet, knees, hands, and elbows. Starting 8 months ago, distinct nodules formed on the affected joints; these occasionally burst and released a "toothpaste-like" discharge. He increasingly had difficulty walking and using his hands. The patient had not sought any medical care since emigrating from Mexico 8 years ago, due to lack of insurance. On exam, he had diffuse subcutaneous nodules on the feet, ankles, knees, elbows, earlobes, and hands, most concentrated in the joint spaces. They were firm, non-tender, and yellow to white in color. One nodule was draining a chalky white exudate. He had numerous cyst-like lesions on the shaft of the penis, restricting movement of the foreskin. Range of motion was severely impaired in all extremities. He had a uric acid level of 10.4, alkaline phosphatase of 164, and C-reactive protein of 16.5. Rheumatologic serologies were negative. X-rays of the affected joints showed osteopenic bone, with areas of periarticular erosions, joint space narrowing, and subchondral sclerosis with overlying tophi, all consistent with advanced gout. Fluid from the draining tophus revealed large collections of monosodium urate crystals. IMPACT: This case is a reminder that physicians should be prepared to recognize and manage not only acute gout flares, but also advanced presentations of chronic gout. Particularly when working in populations with limited healthcare access, the diagnosis and treatment of gout may be considerably delayed. Perhaps more importantly from an internist's perspective, recognizing and treating the sequelae and comorbidities of gout may reduce morbidity and mortality in these patients. DISCUSSION: In gout patients, the presence of one or more tophi is an indication to begin urate-lowering therapy (ULT), using xanthase-oxidase inhibitors, which decrease production of urate, and uricosuric agents, which increase renal excretion of uric acid. ULT targets a serum urate of <6 mg/dL; in severe cases, a target of <5 mg/dL is often used. If serum urate remains elevated on both agents, the next step is to add pegloticase, a recombinant uricase that converts urate into the renally cleared allantoin. Even with optimal control of hyperuricemia, tophi may persist for years before disappearing. Notably, all gout patients are at increased risk for cardiovascular disease, metabolic syndrome, and renal disease. However, patients with tophi have additional complications of joint and bone destruction, compressive neuropathies, and ulceration and infection of the tophi. The presence of tophi is also an independent predictor of mortality

BACKGROUND: All physicians need to be skilled at diagnosing, treating, and managing depression. We designed an unannounced standard patient (USP) case to assess residents' clinical skills in addressing depression and explored how those skills are associated with residents' general clinical skills in order to design targeted curriculum on depression. METHODS: The USP was a 26 y.o. male presenting as a new patient to a clinic complaining of fatigue and problems sleeping. Goals of the case were to diagnose a common presentation of depression and make a treatment/follow-up plan. The USP was trained to have a positive PHQ 2 &PHQ 9, family history of depression, and be willing to engage in medication and/or therapy if offered. A post-visit checklist was used by the SPs to assess communication, patient education, and assessment skills using behaviorally anchored items rated as not done, partly done, or well done. A systematic chart review was conducted to examine treatment, quality of documentation, and referrals. Case fidelity was checked by audiotape and confirmed by PHQ 9 score in the EHR. Evidence based treatment was defined as prescribing an SSRI and/or providing a psychiatric referral; if neither of those, scheduling follow-up for within 2 weeks. RESULTS: 122 residents saw the USP case from 2009-2015. Mean visit length = 45 min, SD 25 (14 to 183 min). The patient was screened for depression with a PHQ 2 in 93% of visits; 82% also had a PHQ 9. Overall, 77 residents (63%) provided appropriate treatment: 8% prescribed an SRRI, 23% provided a referral, 19% did both, 7% prescribed a sleep aid and <2 week follow-up, and 43% provided a combination of these treatments. 45 residents (37%) did not provide appropriate treatment: 27 (60%) prescribed a sleep aid and follow-up >2 weeks and 18 (40%) provided no treatment/referral and follow-up >2 weeks. There were no differences in exploration of medical history or substance use, but 83% of residents who treated appropriately had a PHQ 9 compared to 62% of residents who did not treat appropriately. 71% also included depression on the problem list compared to 13%of residents who did not treat appropriately. Residents who treated appropriately had significantly better clinical skills assessed by the USP including: overall communication (71% vs. 54%, p = 0.00), information gathering (72% vs. 55%, p = 0.01), relationship development (75% vs. 60%, p = 0.03), patient education (55% vs. 21%, p = 0.00), and patient activation skills (33% vs. 13%, p = 0.01). CONCLUSIONS: Although almost all residents obtained the relevant information, only about 50% of residents diagnosed depression. PHQ 9 appears to be associated with providing more effective treatment, supporting the importance of health system screening protocols. Residents' communication and depression-specific patient education and activation skills seem to be related to how they identify and manage depression, suggesting that interventions to build these skills may lead to higher quality care

LEARNING OBJECTIVE #1: Describe the mechanism of septic arthritis LEARNINGOBJECTIVE #2: Recognize the epidemiology, risk factors, and prognosis of patients with septic arthritis caused by Streptococcus pneumoniae CASE: A 43 year-old man with a history of Hodgkin's Lymphoma, treated with chemotherapy and radiation, complicated by avascular necrosis requiring bilateral hip replacements, and myelodysplastic syndrome requiring a splenectomy and stem cell transplant, presented with one month of productive cough, two days of myalgias, and acute on chronic bilateral shoulder and hip pain. On presentation to our institution, he was found to have profound leukocytosis with neutrophilia and bandemia and a computed tomography of the chest suggestive of a multi-lobar pneumonia. His physical exam was remarkable for a high fever, rigors, diminished breath sounds at the lung bases, and decreased range of motion in his right lower extremity due to right hip pain. He was treated empirically with intravenous vancomycin and piperacillin-tazobactam. Blood cultures grew pan-sensitive S. pneumoniae and his antibiotics were narrowed to intravenous ceftriaxone. His hospital course was complicated by persistent leukocytosis, fevers, and right hip pain. Magnetic resonance imaging and a gallium nuclear scan were performed, which suggested infection of his right hip. He underwent an arthrocentesis followed by a right hip wash out without prosthesis removal. He was discharged home on an extended course of antibiotics with resolution of his leukocytosis, fevers, and right hip pain. IMPACT: Our case highlights a relatively uncommon phenomenon, which is septic arthritis caused by S. pneumoniae. Clinicians should be aware of predisposing factors that place patients at risk for developing a joint infection from this organism. DISCUSSION: Septic arthritis occurs via bacterial invasion of the synovial membrane, most commonly by hematogenous spread, leading to an acute inflammatory response involving synovial membrane hyperplasia, local cytokine production, and cartilage destruction. Several studies report a widely disparate prevalence of septic arthritis caused by S. pneumoniae, with most studies reporting a low single digit prevalence. While relatively uncommon, S. pneumoniae arthritis should be considered in patients with extra-articular infections, such as pneumonia or meningitis, and predisposing factors, which include alcoholism, rheumatoid arthritis, immunosuppression, splenectomy, preexisting joint disease, or patients with prosthetic joints. Prosthetic joints pose a fifteen-time greater risk of infection by providing a surface for S. pneumoniae to multiply and form biofilms to defend against circulating leukocytes, complement, and antibiotics. Good functional outcome is seen in the majority of patients treated with appropriate antibiotic therapy and surgical intervention, and often patients with prostheses do not require removal

BACKGROUND: Diabetic medications are approved by the Food and Drug Administration (FDA) based on efficacy in controlled clinical settings. Real world effectiveness may often vary from the results of clinical trials. We attempted to quantify the "efficacy versus effectiveness" gap at our institution. METHODS: We performed a retrospective analysis of all patients prescribed oral diabetic medications at New York University Langone Medical Center, a large urban tertiary care center, using data extracted from our electronic health record from October 2009 to September 2014. We limited the dataset to include newly diagnosed diabetic patients who were started on monotherapy or a combination pill. We excluded patients who were prescribed insulin or multiple diabetic agents. We used two-tailed Welch's t-tests to compare the initial Hemoglobin A1c (HbA1c), final HbA1c, and total HbA1c reduction to clinical trial data used for FDA approval, with statistical significance defined as p<0.05. RESULTS: Among the 566 of the 2452 patients who met our inclusion criteria, the mean age was 62.9 +/- 12.2 years, the majority of whom were male (51.1%), white (61.1%), non-Hispanic (80.4%), and prescribed metformin monotherapy (70.3%). The mean treatment time for each drug class ranged from 32-39 weeks. The mean initial HbA1c for all groups was 8.95%, the mean final HbA1c was 7.44%, and the mean HbA1c reduction was 0.51%. For almost all drug classes, the initial HbA1c was lower than the initial HbA1c from efficacy trials. For most drug classes, effectiveness was about half of the expected value from efficacy trials. Most patients achieved their goal HbA1c levels [Table]. CONCLUSIONS: In our study population, real world effectiveness did not reflect measures of efficacy from controlled clinical settings. The results highlight the need for clinicians to realize that a medication may not perform as well as it does in a controlled setting and they may need to increase the intensity of treatment more quickly than expected. Also, replicating the results of clinical trials in an actual clinical setting is challenging, both from the perspective of data availability and clinical practice patterns. (Table Presented)

BACKGROUND: Electronic health record (EHR)-based clinical decision support tools (CDS) incorporate individualized data to produce patient-specific recommendations at the point-of-care. However, these tools are often limited in their effectiveness, which may be due to poor consideration of usability. The purpose of this study was to evaluate the utilization of a CDS intervention to increase prescription of Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) for patients with heart failure. METHODS: We performed a retrospective study of hospitalized patients with heart failure from the time of CDS implementation, 7/10/13, through 11/30/15. The CDS that we investigated offers providers an opportunity to prescribe an ACEi or ARB or report a contraindication to therapy for patients with documented heart failure. All patients with an EF < 40% who were not on an ACEi or ARB at time of discharge were included in the study. We identified the number of patients for whom the CDS triggered; of those, we categorized provider response as: dismissed, ordered an ACEi/ARB, or contraindication reported. We then performed manual chart review to identify the CDS reported contraindication and structured chart abstraction with standard guidelines to identify gold standard contraindications. We compared each CDS contraindication to gold standard contraindications to determine their accuracy. RESULTS: Out of the 618 subjects who had an EF < 40% but no ACEi or ARB at the time or discharge, 435/618 (70%) had a triggered CDS. Of these 435 subjects for who a CDS was triggered, 180 (41%) were dismissed, 225 (52%) had a contraindication response and 30 (7%) had a prescription for an ACEi/ARB therapy. Overall the accuracy of the documented CDS was 42% (Table 1). CONCLUSIONS: The CDS that we reviewed was poorly utilized and contraindications documented in the tool poorly correlated with patient clinical status reflected elsewhere in the EHR. These findings identify this CDS as a possible impedance to user workflow. One way to improve CDS tools at the point of care is through thorough usability testing and consideration of physician workflow prior to implementation. (Table Presented)

Paclitaxel-coated drug-coated balloons have significantly improved short-term and mid-term clinical outcomes in patients with symptomatic femoropopliteal peripheral artery disease. However, long-term results are awaited. Furthermore, the clinical success of drug-coated balloons in the infrapopliteal peripheral arteries has been more modest and overall similar to traditional balloon angioplasty, and remains an area of unmet clinical need. This article provides an overview of the clinical evidence for paclitaxel-coated balloons in the femoropopliteal and infrapopliteal peripheral artery distributions and future directions in this area.

BACKGROUND: In the Spring and Summer of 2016, a text-messaging intervention to titrate basal insulin in patients with type 2 diabetes and poor glycemic control was implemented at two safety net health care systems in New York City. The goal of the current study was to conduct a qualitative evaluation assessing barriers to, and facilitators of, implementation of the mobile insulin titration intervention (called "MITI"). METHODS: We conducted in-depth qualitative interviews with patients (N = 36) and physician, nursing and administrative staff (N = 19) at the two health care systems implementing MITI. Interviews were transcribed and coded by two study investigators using a codebook guided by the Consolidated Framework for Implementation Research and through iterative, consensus driven content analysis. RESULTS: Patients and staff perceived MITI as convenient and timesaving for patients, easy to use, and effective at achieving its clinical goals. Patients were comfortable sharing health information via text, and felt good about communicating with their health team remotely. Interviewees across stakeholder groups felt that MITI was helpful beyond insulin titration by reminding and motivating patients to engage in healthy behaviors and improving medication adherence. Staff felt MITI worked well with existing workflows and expressed a desire to see MITI expanded to other chronic conditions. Nurses responsible for weekly titration reported initial concerns over safety/liability, time required to deliver the program, difficulties reaching patients for titration calls and the need for ongoing support/training in using the online texting platform. Perceived barriers to MITI implementation reported by providers included perceived lack of patient cell phone access or texting capabilities and patient language barriers. There was also a theme that emerged across interviewees of an unmet need for additional diabetes management support among this population, beyond insulin support provided by MITI. The project team made several modifications to MITI operations in response to these findings. CONCLUSIONS: Patients and staff were overwhelmingly supportive of MITI and believed it had many benefits. Initial implementation of MITI should address nurse comfort, workload and training, and sites should provide ongoing support and training for nurses after implementation. Future research should explore options for integrating additional diabetes support for patients enrolled in MITI or after they are discharged from the program