C. Christopher Smith

Esophageal sphincter device for gastroesophageal reflux disease.

BACKGROUND Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter. METHODS We prospectively assessed 100 patients with gastroesophageal reflux disease before and after sphincter augmentation. The study did not include a concurrent control group. The primary outcome measure was normalization of esophageal acid exposure or a 50% or greater reduction in exposure at 1 year. Secondary outcomes were 50% or greater improvement in quality of life related to gastroesophageal reflux disease and a 50% or greater reduction in the use of proton-pump inhibitors at 1 year. For each outcome, the prespecified definition of successful treatment was achievement of the outcome in at least 60% of the patients. The 3-year results of a 5-year study are reported. RESULTS The primary outcome was achieved in 64% of patients (95% confidence interval [CI], 54 to 73). For the secondary outcomes, a reduction of 50% or more in the use of proton-pump inhibitors occurred in 93% of patients, and there was improvement of 50% or more in quality-of-life scores in 92%, as compared with scores for patients assessed at baseline while they were not taking proton-pump inhibitors. The most frequent adverse event was dysphagia (in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years). Serious adverse events occurred in six patients, and in six patients the device was removed. CONCLUSIONS In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety. (Funded by Torax Medical; ClinicalTrials.gov number, NCT00776997.).

The Return of Bedside Rounds: An Educational Intervention

BackgroundBedside rounds have decreased in frequency on teaching services. Perceived barriers toward bedside rounds are inefficiency and patient and house staff lack of preference for this mode of rounding.ObjectivesTo evaluate the impact of a bedside rounding intervention on the frequency of bedside rounding, duration of patient encounters and rounding sessions, and patient and resident attitudes toward bedside rounds.DesignA pre- and postintervention design, with a bedside rounding workshop midway through two consecutive internal medicine rotations, with daily resident interviews, patient surveys, and an end-of-the-year survey given to all Medicine house staff.ParticipantsMedicine house staff and medicine patients.MeasuresFrequency of bedside rounds, duration of new patient encounters and rounding sessions, and patient and house staff attitudes regarding bedside rounds.ResultsForty-four residents completed the bedside rounding workshop. Comparing the preintervention and postintervention phases, bedside rounds increased from <1% to 41% (p < 0.001). The average duration of walk rounding encounters was 16 min, and average duration of bedside rounding encounters was 15 min (p = 0.42). Duration of rounds was 95 and 98 min, respectively (p = 0.52). Patients receiving bedside rounds preferred bedside rounds (99% vs. 83%, p = 0.03) and perceived more time spent at the bedside by their team (p < 0.001). One hundred twelve house staff (71%) responded, with 73% reporting that bedside rounds are better for patient care. House staff performing bedside rounds were less likely to believe that bedside rounds were more educational (53% vs. 78%, p = 0.01).ConclusionsBedside rounding increased after an educational intervention, and the time to complete bedside rounding encounters was similar to alternative forms of rounding. Patients preferred bedside rounds and perceived more time spent at the bedside when receiving bedside rounds. Medicine residents performing bedside rounds were less likely to believe bedside rounds were more educational, but all house staff valued the importance of bedside rounding for the delivery of patient care.

Colorectal cancer screening and familial risk: a survey of internal medicine residents’ knowledge and practice patterns

OBJECTIVE:Risk stratification is essential to the appropriate use of colorectal cancer screening recommendations. The principal objective of this study was to assess the knowledge and screening behavior of internal medicine (IM) residents regarding familial colorectal cancer.METHODS:We conducted a survey of IM residents in their second and third year of postgraduate training from two university-based programs (n = 127). The survey instrument assessed physician knowledge of screening recommendations and current practices for individuals with a family history of colorectal cancer, adenomatous polyps, familial adenomatous polyposis, and hereditary nonpolyposis colorectal cancer. The instrument also elicited data regarding familial risk assessment, documentation, and notification of at-risk family members.RESULTS:Eighty-one IM eligible residents (81%) completed the survey. Most respondents identified a family history of colorectal cancer as an important factor in assessing colorectal cancer risk and appropriately implemented relevant screening recommendations. However, for patients with a family history of adenomatous polyps diagnosed before age 60 yr, knowledge and adherence to recommendations advocating screening at age 40 was relatively poor. More importantly, for patients with familial adenomatous polyposis and hereditary nonpolyposis colorectal cancer, respondents lacked the necessary risk assessment skills and knowledge to appropriately implement current recommendations. There were no consistent differences in knowledge or screening behavior when stratified on the basis of program site or postgraduate year status.CONCLUSION:Many IM residents are deficient in their knowledge, risk assessment skills, and screening practices for patients at familial risk of colorectal cancer. Effective educational strategies that promote awareness regarding familial risk, risk assessment skills, and appropriate use of relevant screening guidelines are needed.

Procedural Competence in Internal Medicine Residents: Validity of a Central Venous Catheter Insertion Assessment Instrument

Purpose Despite mandates from accreditation bodies for programs to ensure procedural competence, standardized measures do not exist to assess residents’ skills in performing central venous catheter (CVC) insertion. The objective of the present study was to develop an instrument to assess residents in subclavian (SC) CVC insertion, to set performance standards, and to validate the tool using performance data. Method In 2007, the authors convened experts to create an assessment tool for CVC insertion using a modified Delphi method. They applied the Angoff method to a second set of experts to determine minimum passing scores (MPSs) for both the borderline trainee and the competent trainee. Two faculty evaluators then used the checklist to assess residents performing CVCs on simulators. Results The authors created and experts confirmed a 24-item checklist. Using the Angoff method, the MPS required completion of 10 major and 2 minor criteria for a trainee to show borderline proficiency with CVC insertion under supervision. This MPS was correlated with a global rating of 2 on a 5-point scale. The MPS for competence was 17 major and 5 minor criteria. None of the residents deemed competent on a global rating scale achieved the MPS for competence. Conclusions The authors were able to create and validate a consensus-driven procedural assessment tool with data-driven standards for basic proficiency and competence that faculty can use to assess residents as they perform CVC insertion.

Simulation training and its effect on long-term resident performance in central venous catheterization

Introduction: Simulation is a safe alternative to practicing procedural skills on patients. However, few published studies have examined the long-term effect of simulation technology on bedside procedures such as central venous catheter (CVC) insertion. Methods: To determine whether simulation-based teaching improves procedural comfort, performance, and clinical events in CVC insertion, over traditional methods of procedural teaching, and to assess the long-term effect of this training, we conducted a prospective, randomized controlled trial with 53 postgraduate year-1 and postgraduate year-2 medical residents at a tertiary-care teaching hospital. At the start of the study, we assessed all residents’ procedural comfort and previous training and experience with CVCs. We then measured their baseline performance in placing CVCs on simulators, using a validated assessment tool (pretest). For the intervention group, we reassessed performance immediately after simulation training (posttest). All subjects then placed actual CVCs as clinically indicated while on their medical intensive care unit rotations, under the supervision of critical care faculty. We measured clinical events associated with these CVCs. After their medical intensive care unit rotations, we reassessed CVC insertion skills on simulators and procedural comfort of all subjects (delayed posttest). Results: Intervention subjects demonstrated a significant improvement in skills immediately after simulation training. At delayed posttesting, performance diminished somewhat in the intervention subjects and was not significantly different from control subjects; however, a significant increase over pretest scores persisted in both groups. Conclusions: A CVC insertion simulation course improves procedural skills. These skills decline over time, and simulation conferred no long-term additional benefit over traditional methods of procedural teaching.

Creation of an innovative inpatient medical procedure service and a method to evaluate house staff competency

INTRODUCTION: Training residents in medical procedures is an area of growing interest. Studies demonstrate that internal medicine residents are inadequately trained to perform common medical procedures, and program directors report residents do not master these essential skills. The American Board of Internal Medicine requires substantiation of competence in procedure skills for all internal medicine residents; however, for most procedures, standards of competence do not exist.OBJECTIVE: 1) Create a new and standardized approach to teaching, performing, and evaluating inpatient medical procedures; 2) Determine the number of procedures required until trainees develop competence, by assessing both clinical knowledge and psychomotor skills; 3) Improve patient safety.DESIGN: A Medical Procedure Service (MPS), consisting of select faculty who are experts at common impatient procedures, was established to supervise residents performing medical procedures. Faculty monitor residents’ psychomotor performance, while clinical knowledge is taught through a complementary, comprehensive curriculum. After the completion of each procedure, the trainee and supervising faculty member independently complete online questionnaires.RESULTS: During this pilot program, 246 procedures were supervised, with a pooled major complication rate of 3.7%. 123 thoracenteses were supervised, with a pneumothorax rate of 3.3%; this compares favorably with a pooled analysis of the literature. 87% of surveyed house staff felt the procedure service helped in their education of medical procedures.CONCLUSIONS: The “see one, do one, teach one” model of procedure education is dangerously inadequate. Through the development of a Medical Procedure Service, and an associated procedure curriculum and a mechanism of evaluation, we hope to reduce the rate of complications and errors related to medical procedures and to determine at what point competency is achieved for these procedures.

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux

BACKGROUND & AIMS Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. METHODS We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. RESULTS Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. CONCLUSIONS Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.

Effect of a Systems Intervention on the Quality and Safety of Patient Handoffs in an Internal Medicine Residency Program

ABSTRACTBACKGROUNDPoor quality handoffs have been identified as a major patient safety issue.In residency programs, problematic handoffs may be an unintended consequence of duty-hour restrictions, and key data are frequently omitted from written handoffs because of the lack of standardization of content.OBJECTIVEDetermine whether an intervention that facilitates face-to-face communication supported by an electronic template improves the quality and safety of handoffs.DESIGNBefore-after trial.PARTICIPANTSThirty-nine interns providing nighttime coverage over 132 intern shifts, representing ∼9,200 handoffs.INTERVENTIONSTwo interventions were implemented serially—an alteration of the shift model to facilitate face-to-face verbal communication between the primary and nighttime covering physicians and an electronic template for the day-to-night handoff.MEASUREMENTSOverall satisfaction and handoff quality were measured using a survey tool administered at the end of each intern shift. Written handoff quality, specifically the documentation of key components, was also assessed before and after the template intervention by study investigators. Interns used the survey tool to report patient safety events related to poor quality handoffs, which were validated by study investigators.RESULTSIn adjusted analyses comparing intern cohorts with similar levels of training, overall satisfaction with the new handoff processes improved significantly (p < 0.001) post intervention. Verbal handoff quality (4/10 measures) and written handoff quality (5/6 measures) also improved significantly. Study investigators also found significant improvement in documentation of key components in the written handoff. Interns reported significantly fewer reported data omissions (p = 0.001) and a non-significant reduction in near misses (p = 0.056), but no significant difference in adverse events (p = 0.41) post intervention.CONCLUSIONSRedesign of shift models common in residency programs to minimize the number of handoffs and facilitate face-to-face communication, along with implementation of electronic handoff templates, improves the quality of handoffs in a learning environment.

Development of key performance indicators to evaluate centralized intake for patients with osteoarthritis and rheumatoid arthritis

IntroductionCentralized intake is integral to healthcare systems to support timely access to appropriate health services. The aim of this study was to develop key performance indicators (KPIs) to evaluate centralized intake systems for patients with osteoarthritis (OA) and rheumatoid arthritis (RA).MethodsPhase 1 involved stakeholder meetings including healthcare providers, managers, researchers and patients to obtain input on candidate KPIs, aligned along six quality dimensions: appropriateness, accessibility, acceptability, efficiency, effectiveness, and safety. Phase 2 involved literature reviews to ensure KPIs were based on best practices and harmonized with existing measures. Phase 3 involved a three-round, online modified Delphi panel to finalize the KPIs. The panel consisted of two rounds of rating and a round of online and in-person discussions. KPIs rated as valid and important (≥7 on a 9-point Likert scale) were included in the final set.ResultsTwenty-five KPIs identified and substantiated during Phases 1 and 2 were submitted to 27 panellists including healthcare providers, managers, researchers, and patients in Phase 3. After the in-person meeting, three KPIs were removed and six were suggested. The final set includes 9 OA KPIs, 10 RA KPIs and 9 relating to centralized intake processes for both conditions. All 28 KPIs were rated as valid and important.ConclusionsArthritis stakeholders have proposed 28 KPIs that should be used in quality improvement efforts when evaluating centralized intake for OA and RA. The KPIs measure five of the six dimensions of quality and are relevant to patients, practitioners and health systems.

Procedural instruction in invasive bedside procedures: a systematic review and meta-analysis of effective teaching approaches

Importance Optimal approaches to teaching bedside procedures are unknown. Objective To identify effective instructional approaches in procedural training. Data sources We searched PubMed, EMBASE, Web of Science and Cochrane Library through December 2014. Study selection We included research articles that addressed procedural training among physicians or physician trainees for 12 bedside procedures. Two independent reviewers screened 9312 citations and identified 344 articles for full-text review. Data extraction and synthesis Two independent reviewers extracted data from full-text articles. Main outcomes and measures We included measurements as classified by translational science outcomes T1 (testing settings), T2 (patient care practices) and T3 (patient/public health outcomes). Due to incomplete reporting, we post hoc classified study outcomes as ‘negative’ or ‘positive’ based on statistical significance. We performed meta-analyses of outcomes on the subset of studies sharing similar outcomes. Results We found 161 eligible studies (44 randomised controlled trials (RCTs), 34 non-RCTs and 83 uncontrolled trials). Simulation was the most frequently published educational mode (78%). Our post hoc classification showed that studies involving simulation, competency-based approaches and RCTs had higher frequencies of T2/T3 outcomes. Meta-analyses showed that simulation (risk ratio (RR) 1.54 vs 0.55 for studies with vs without simulation, p=0.013) and competency-based approaches (RR 3.17 vs 0.89, p<0.001) were effective forms of training. Conclusions and relevance This systematic review of bedside procedural skills demonstrates that the current literature is heterogeneous and of varying quality and rigour. Evidence is strongest for the use of simulation and competency-based paradigms in teaching procedures, and these approaches should be the mainstay of programmes that train physicians to perform procedures. Further research should clarify differences among instructional methods (eg, forms of hands-on training) rather than among educational modes (eg, lecture vs simulation).