Christopher M. Wittich

Ten Common Questions (and Their Answers) About Off-label Drug Use

The term off-label drug use (OLDU) is used extensively in the medical literature, continuing medical education exercises, and the media. Yet, we propose that many health care professionals have an underappreciation of its definition, prevalence, and implications. This article introduces and answers 10 questions regarding OLDU in an effort to clarify the practices meaning, breadth of application, acceptance, and liabilities. Off-label drug use involves prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US Food and Drug Administration. Since the Food and Drug Administration does not regulate the practice of medicine, OLDU has become common. It occurs in every specialty of medicine, but it may be more common in areas of medicine in which the patient population is less likely to be included in clinical trials (eg, pediatric, pregnant, or psychiatric patients). Pharmaceutical companies are not allowed to promote their medications for an off-label use, which has lead to several large settlements for illegal marketing. To limit liability, physicians should prescribe medications only for indications that they believe are in the best interest of the patient. In addition, health care professionals should educate themselves about OLDU to weigh the risks and benefits and provide the best possible care for their patients.

Perspective: Transformative learning: a framework using critical reflection to link the improvement competencies in graduate medical education.

Quality improvement (QI) in health care involves activities ranging from enhancing personal practice to reforming the larger health care system. The Accreditation Council for Graduate Medical Education recognizes this broad definition of QI in its requirement that physicians-in-training demonstrate competence in practice-based learning and improvement (PBLI) and systems-based practice (SBP). Creative metaphors have been used to teach the PBLI and SBP competencies, but conceptual frameworks describing the relationship between these competencies are needed. Transformative learning is an adult education theory that states individuals must critically reflect on life events in order to change their beliefs or behaviors. The authors propose that critical reflection during transformative learning can conceptually link PBLI and SBP. Reflection on personal experience with suboptimal patient care leads to recognizing personal or system limitations. Addressing personal limitations improves individual practice (PBLI), whereas applying QI methodologies leads to large-scale improvements (SBP). Educators who adopt the transformative learning framework should be able to design meaningful QI curricula that encourage residents to be reflective and empower them with QI skills.

Kearns–Sayre syndrome: a case series of 35 adults and children

Background Kearns–Sayre syndrome (KSS) is a rare mitochondrial cytopathy, first described at Mayo Clinic in 1958. Aims We aimed to define patient and disease characteristics in a large group of adult and pediatric patients with KSS. Methods We retrospectively searched the Mayo Clinic medical index patient database for the records of patients with KSS between 1976 and 2009. The 35 patients identified with KSS were analyzed in terms of demographic characteristics, presenting signs and symptoms, diagnostic features, clinical evolution, and associations between disease features and the development of disability. Results The mean (standard [SD]) age at KSS presentation was 17 (10) years, but the mean age at diagnosis was 26 (15) years. Ophthalmologic symptoms developed in all patients, and neurologic and cardiac involvement was common. Only four patients (11%) in the series died, but all deaths were from sudden cardiac events. The development of physical disability was significantly associated with cognitive decline (P=0.004) but not with other clinical features, such as sex or sudden cardiac death. Conclusion We report the largest case series to date of patients with KSS from a single institution. In addition to the conduction system abnormalities identified in previous series, our cohort included patients with syncope and sudden cardiac death. This underscores the need to consider formal electrophysiologic studies and prophylactic defibrillators in patients with KSS.

Incentive and Reminder Strategies to Improve Response Rate for Internet-Based Physician Surveys: A Randomized Experiment

Background Most research on how to enhance response rates in physician surveys has been done using paper surveys. Uncertainties remain regarding how to enhance response rates in Internet-based surveys. Objective To evaluate the impact of a low-cost nonmonetary incentive and paper mail reminders (formal letter and postcard) on response rates in Internet-based physician surveys. Methods We executed a factorial-design randomized experiment while conducting a nationally representative Internet-based physician survey. We invited 3966 physicians (randomly selected from a commercial database of all licensed US physicians) via email to complete an Internet-based survey. We used 2 randomly assigned email messages: one message offered a book upon survey completion, whereas the other did not mention the book but was otherwise identical. All nonrespondents received several email reminders. Some physicians were further assigned at random to receive 1 reminder via paper mail (either a postcard or a letter) or no paper reminder. The primary outcome of this study was the survey response rate. Results Of the 3966 physicians who were invited, 451 (11.4%) responded to at least one survey question and 336 (8.5%) completed the entire survey. Of those who were offered a book, 345/2973 (11.6%) responded compared with 106/993 (10.7%) who were not offered a book (odds ratio 1.10, 95% CI 0.87-1.38, P=.42). Regarding the paper mail reminder, 168/1572 (10.7%) letter recipients, 148/1561 (9.5%) postcard recipients, and 69/767 (9.0%) email-only recipients responded (P=.35). The response rate for those receiving letters or postcards was similar (odds ratio 1.14, 95% CI 0.91-1.44, P=.26). Conclusions Offering a modest nonmonetary incentive and sending a paper reminder did not improve survey response rate. Further research on how to enhance response rates in Internet-based physician surveys is needed.

Validation of a method to measure resident doctors' reflections on quality improvement

Medical Education 2010: 44 : 248–255

Flipping the Quality Improvement Classroom in Residency Education

Purpose The flipped classroom (FC), in which instructional content is delivered before class with class time devoted to knowledge application, has the potential to engage residents. A Mayo Clinic Internal Medicine Residency Program study was conducted to validate an FC perception instrument (FCPI); determine whether participation improved FC perceptions; and determine associations between resident characteristics, change in quality improvement (QI) knowledge, and FC perception scores. Method All 143 internal medicine residents at Mayo Clinic, Rochester participated from 2014 to 2015; some experienced a flipped QI curriculum and others completed the traditional nonflipped course. The FCPI was developed, and factor analysis revealed an intuitive two-factor structure: preclass activity and in-class application. Residents were surveyed before and after the monthlong curriculum to measure changes in perception, and the QI Knowledge Assessment Tool was employed to measure knowledge improvement. Results Postcourse FCPI scores significantly increased for three of the eight items. QI knowledge increased significantly among residents who experienced the FC compared with residents who completed the non-FC curriculum. Those without prior FC exposure demonstrated a significant increase in QI knowledge compared with those with previous FC experience. The FCPI had compelling validity evidence with improved scores after curriculum exposure and associations with greater engagement in online modules. Conclusions Residents who participated in the FC demonstrated improved QI knowledge compared with the control group. Residents valued the in-class application sessions more than the online component. These findings have important implications for graduate medical education as residency training programs increasingly use FC models.

Validation of a method for measuring medical students' critical reflections on professionalism in gross anatomy

Improving professional attitudes and behaviors requires critical self reflection. Research on reflection is necessary to understand professionalism among medical students. The aims of this prospective validation study at the Mayo Medical School and Cleveland Clinic Lerner College of Medicine were: (1) to develop and validate a new instrument for measuring reflection on professionalism, and (2) determine whether learner variables are associated with reflection on the gross anatomy experience. An instrument for assessing reflections on gross anatomy, which was comprised of 12 items structured on five‐point scales, was developed. Factor analysis revealed a three‐dimensional model including low reflection (four items), moderate reflection (five items), and high reflection (three items). Item mean scores ranged from 3.05 to 4.50. The overall mean for all 12 items was 3.91 (SD = 0.52). Internal consistency reliability (Cronbachs α) was satisfactory for individual factors and overall (Factor 1 α = 0.78; Factor 2 α = 0.69; Factor 3 α = 0.70; Overall α = 0.75). Simple linear regression analysis indicated that reflection scores were negatively associated with teamwork peer scores (P = 0.018). The authors report the first validated measurement of medical student reflection on professionalism in gross anatomy. Critical reflection is a recognized component of professionalism and may be important for behavior change. This instrument may be used in future research on professionalism among medical students. Anat Sci Educ 6: 232–238.

Functional Neuroimaging Correlates of Burnout among Internal Medicine Residents and Faculty Members

Burnout is prevalent in residency training and practice and is linked to medical error and suboptimal patient care. However, little is known about how burnout affects clinical reasoning, which is essential to safe and effective care. The aim of this study was to examine how burnout modulates brain activity during clinical reasoning in physicians. Using functional Magnetic Resonance Imaging (fMRI), brain activity was assessed in internal medicine residents (n = 10) and board-certified internists (faculty, n = 17) from the Uniformed Services University (USUHS) while they answered and reflected upon United States Medical Licensing Examination and American Board of Internal Medicine multiple-choice questions. Participants also completed a validated two-item burnout scale, which includes an item assessing emotional exhaustion and an item assessing depersonalization. Whole brain covariate analysis was used to examine blood-oxygen-level-dependent (BOLD) signal during answering and reflecting upon clinical problems with respect to burnout scores. Higher depersonalization scores were associated with less BOLD signal in the right dorsolateral prefrontal cortex and middle frontal gyrus during reflecting on clinical problems and less BOLD signal in the bilateral precuneus while answering clinical problems in residents. Higher emotional exhaustion scores were associated with more right posterior cingulate cortex and middle frontal gyrus BOLD signal in residents. Examination of faculty revealed no significant influence of burnout on brain activity. Residents appear to be more susceptible to burnout effects on clinical reasoning, which may indicate that residents may need both cognitive and emotional support to improve quality of life and to optimize performance and learning. These results inform our understanding of mental stress, cognitive control as well as cognitive load theory.

Speaker Introductions at Internal Medicine Grand Rounds: Forms of Address Reveal Gender Bias

BACKGROUND Gender bias has been identified as one of the drivers of gender disparity in academic medicine. Bias may be reinforced by gender subordinating language or differential use of formality in forms of address. Professional titles may influence the perceived expertise and authority of the referenced individual. The objective of this study is to examine how professional titles were used in the same and mixed-gender speaker introductions at Internal Medicine Grand Rounds (IMGR). METHODS A retrospective observational study of video-archived speaker introductions at consecutive IMGR was conducted at two different locations (Arizona, Minnesota) of an academic medical center. Introducers and speakers at IMGR were physician and scientist peers holding MD, PhD, or MD/PhD degrees. The primary outcome was whether or not a speakers professional title was used during the first form of address during speaker introductions at IMGR. As secondary outcomes, we evaluated whether or not the speakers professional title was used in any form of address during the introduction. RESULTS Three hundred twenty-one forms of address were analyzed. Female introducers were more likely to use professional titles when introducing any speaker during the first form of address compared with male introducers (96.2% [102/106] vs. 65.6% [141/215]; p < 0.001). Female dyads utilized formal titles during the first form of address 97.8% (45/46) compared with male dyads who utilized a formal title 72.4% (110/152) of the time (p = 0.007). In mixed-gender dyads, where the introducer was female and speaker male, formal titles were used 95.0% (57/60) of the time. Male introducers of female speakers utilized professional titles 49.2% (31/63) of the time (p < 0.001). CONCLUSION In this study, women introduced by men at IMGR were less likely to be addressed by professional title than were men introduced by men. Differential formality in speaker introductions may amplify isolation, marginalization, and professional discomfiture expressed by women faculty in academic medicine.

Measuring Faculty Reflection on Adverse Patient Events: Development and Initial Validation of a Case-Based Learning System

ABSTRACTBACKGROUNDCritical reflection by faculty physicians on adverse patient events is important for changing physician’s behaviors. However, there is little research regarding physician reflection on quality improvement (QI).OBJECTIVETo develop and validate a computerized case-based learning system (CBLS) to measure faculty physicians’ reflections on adverse patient events.DESIGNProspective validation study.PARTICIPANTSStaff physicians in the Department of Medicine at Mayo Clinic Rochester.MAIN MEASURESThe CBLS was developed by Mayo Clinic information technology, medical education, and QI specialists. The reflection questionnaire, adapted from a previously validated instrument, contained eight items structured on five-point scales. Three cases, representing actual adverse events, were developed based on the most common error types: systems, medication, and diagnostic. In 2009, all Mayo Clinic hospital medicine, non-interventional cardiology, and pulmonary faculty were invited to participate. Faculty reviewed each case, determined the next management step, rated case generalizability and relevance, and completed the reflection questionnaire. Factor analysis and internal consistency reliability were calculated. Associations between reflection scores and characteristics of faculty and patient cases were determined.KEY RESULTSForty-four faculty completed 107 case reflections. The CBLS was rated as average to excellent in 95 of 104 (91.3%) completed satisfaction surveys. Factor analysis revealed two levels of reflection: Minimal and High. Internal consistency reliability was very good (overall Cronbach’s α = 0.77). Item mean scores ranged from 2.89 to 3.73 on a five-point scale. The overall reflection score was 3.41 (standard deviation 0.64). Reflection scores were positively associated with case generalizability (p = 0.001), and case relevance (p = 0.02).CONCLUSIONSThe CBLS is a valid method for stratifying faculty physicians’ levels of reflection on adverse patient events. Reflection scores are associated with case generalizability and relevance, indicating that reflection improves with pertinent patient encounters. We anticipate that this instrument will be useful in future research on QI among low versus high-reflecting physicians.