Publications by authors named "Tejal K Gandhi"

120 Publications

Don't Go to the Hospital Alone: Ensuring Safe, Highly Reliable Patient Visitation.

Authors:
Tejal K Gandhi

Jt Comm J Qual Patient Saf 2022 Jan 29;48(1):61-64. Epub 2021 Oct 29.

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http://dx.doi.org/10.1016/j.jcjq.2021.10.006DOI Listing
January 2022

COVID-19 and Patient Safety: Time to Tap Into Our Investment in High Reliability.

J Patient Saf 2021 06;17(4):331-333

Press Ganey Associates LLC, Boston, MA.

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http://dx.doi.org/10.1097/PTS.0000000000000843DOI Listing
June 2021

Fighting a common enemy: a catalyst to close intractable safety gaps.

BMJ Qual Saf 2021 02 16;30(2):141-145. Epub 2020 Jul 16.

Press Ganey Associates LLC, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1136/bmjqs-2020-011390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841492PMC
February 2021

Reducing the Risk of Diagnostic Error in the COVID-19 Era.

J Hosp Med 2020 06;15(6):363-366

Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas.

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http://dx.doi.org/10.12788/jhm.3461DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7289509PMC
June 2020

Impact of multidisciplinary team huddles on patient safety: a systematic review and proposed taxonomy.

BMJ Qual Saf 2020 10 7;29(10):1-2. Epub 2020 Apr 7.

Department of Emergency Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.

Background: Despite significant advances, patient safety remains a critical public health concern. Daily huddles-discussions to identify and respond to safety risks-have been credited with enhancing safety culture in operationally complex industries including aviation and nuclear power. More recently, huddles have been endorsed as a mechanism to improve patient safety in healthcare. This review synthesises the literature related to the impact of hospital-based safety huddles.

Methods: We conducted a systematic review of peer-reviewed literature related to scheduled, multidisciplinary, hospital-based safety huddles through December 2019. We screened for studies (1) in which huddles were the primary intervention being assessed and (2) that measured the huddle programme's apparent impact using at least one quantitative metric.

Results: We identified 1034 articles; 24 met our criteria for review, of which 19 reflected unit-based huddles and 5 reflected hospital-wide or multiunit huddles. Of the 24 included articles, uncontrolled pre-post comparison was the prevailing study design; we identified only two controlled studies. Among the 12 unit-based studies that provided complete measures of statistical significance for reported outcomes, 11 reported statistically significant improvement among some or all outcomes. The objectives of huddle programmes and the language used to describe them varied widely across the studies we reviewed.

Conclusion: While anecdotal accounts of successful huddle programmes abound and the evidence we reviewed appears favourable overall, high-quality peer-reviewed evidence regarding the effectiveness of hospital-based safety huddles, particularly at the hospital-wide level, is in its earliest stages. Additional rigorous research-especially focused on huddle programme design and implementation fidelity-would enhance the collective understanding of how huddles impact patient safety and other targeted outcomes. We propose a taxonomy and standardised reporting measures for future huddle-related studies to enhance comparability and evidence quality.
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http://dx.doi.org/10.1136/bmjqs-2019-009911DOI Listing
October 2020

Advancing Safety and Equity Together.

N Engl J Med 2020 Jan;382(4):301-303

From the Department of Quality and Safety and the Department of Diversity, Inclusion, and Experience, Brigham and Women's Hospital (K.S.), and the Institute for Healthcare Improvement (K.S., T.K.G.) - both in Boston.

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http://dx.doi.org/10.1056/NEJMp1911700DOI Listing
January 2020

Transforming concepts in patient safety: a progress report.

BMJ Qual Saf 2018 12 17;27(12):1019-1026. Epub 2018 Jul 17.

Medicine, University of California San Francisco, San Francisco, California, USA.

In 2009, the National Patient Safety Foundation's Lucian Leape Institute (LLI) published a paper identifying five areas of healthcare that require system-level attention and action to advance patient safety.The authors argued that to truly transform the safety of healthcare, there was a need to address medical education reform; care integration; restoring joy and meaning in work and ensuring the safety of the healthcare workforce; consumer engagement in healthcare and transparency across the continuum of care. In the ensuing years, the LLI convened a series of expert roundtables to address each concept, look at obstacles to implementation, assess potential for improvement, identify potential implementation partners and issue recommendations for action. Reports of these activities were published between 2010 and 2015. While all five areas have seen encouraging developments, multiple challenges remain. In this paper, the current members of the LLI (now based at the Institute for Healthcare Improvement) assess progress made in the USA since 2009 and identify ongoing challenges.
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http://dx.doi.org/10.1136/bmjqs-2017-007756DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6288701PMC
December 2018

Enhancing problem list documentation in electronic health records using two methods: the example of prior splenectomy.

BMJ Qual Saf 2018 Jan 28;27(1):40-47. Epub 2017 Jul 28.

Information Systems, Partners HealthCare, Somerville, Massachusetts, USA.

Background: Quality improvement professionals often choose between patient-specific interventions, like clinical decision support (CDS), and population-based interventions, like registries or care management. In this paper, we explore the synergy of these two strategies, targeting the problem of procedure documentation for patients with a history of splenectomy.

Methods: We developed a population health documentation (PHD) intervention and a CDS intervention to improve splenectomy documentation within our electronic health record. Rates of splenectomy documentation were collected before and after the implementation of both interventions to assess their impact on the rate of procedure documentation.

Results: Both the PHD and CDS interventions led to statistically significant (p<0.001) increases in the baseline rate of splenectomy documentation of 27.4 documentations per month. During the PHD intervention, 444.7 splenectomies were documented per month, while 40.8 splenectomies per month were documented during the CDS intervention.

Discussion: Both approaches were successful, with the PHD intervention leading to a larger number of incremental procedure documentations, in batches, and the CDS intervention augmenting procedure documentation on an ongoing basis. Our results suggest that population health and CDS strategies complement each other and, where possible, should be used in conjunction.

Conclusions: PHD and CDS strategies may best be used in conjunction to create a symbiotic relationship in which current problem and procedure documentation gaps are closed using PHD strategies, while new gaps are prevented through ongoing CDS interventions.
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http://dx.doi.org/10.1136/bmjqs-2017-006707DOI Listing
January 2018

Partnering to Lead a Culture of Safety.

J Healthc Manag 2017 Jul/Aug;62(4):234-237

Gary S. Kaplan, MD, FACMPE, chairman and CEO, Virginia Mason Health System, Seattle, Washington; Tejal K. Gandhi, MD, CPPS, chief clinical and safety officer, Institute for Healthcare Improvement, president, Lucian Leape Institute, and president, Certification Board for Professionals in Patient Safety, Boston, Massachusetts; Deborah J. Bowen, FACHE, CAE, president and CEO, American College of Healthcare Executives (ACHE), Chicago, Illinois; and Charles D. Stokes, FACHE, interim president and CEO, Memorial Hermann Health System, Houston, Texas, and Chairman, ACHE Board of Governors.

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http://dx.doi.org/10.1097/JHM-D-17-00084DOI Listing
July 2018

Closing the Gap and Raising the Bar: Assessing Board Competency in Quality and Safety.

Jt Comm J Qual Patient Saf 2017 06 18;43(6):267-274. Epub 2017 Apr 18.

Background: Despite recognition of the important role that governance and executive leaders play in ensuring patient safety and quality, little research has examined leaders' involvement in these areas beyond surveys that assess higher-level knowledge and understanding of patient and workforce safety concepts.

Methods: A survey was sent to a convenience sample of board members and CEOs, as well as unpaired safety and quality leaders (SQLs). The survey included approximately 36 questions asking board members and other non-CEO executives their knowledge, understanding, and board activities related to safety and quality, and SQLs their perceptions of their own boards' knowledge, understanding, and activities related to safety and quality. An analysis of the responses of each of the three groups was conducted to assess baseline ratings, as well as to examine similarities and differences.

Results: Overall, similar patterns of self-reported knowledge, understanding, and activities related to safety and quality were evident between the board and CEO groups across virtually all areas examined in this survey, although groups were unpaired. Differences of varying degree were found at the level of individual survey items between board members' and CEOs' responses. SQL ratings were generally lower than the ratings of both board members and CEOs.

Conclusion: This survey reveals specific areas of focus for improving governance and leadership practices at board meetings, as well as several areas where knowledge and understanding of safety and quality were variable. Further research and consensus would be beneficial to identify best practices for board education and governance activities to drive quality and safety.
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http://dx.doi.org/10.1016/j.jcjq.2017.03.003DOI Listing
June 2017

Safety Lessons from the NIH Clinical Center.

Authors:
Tejal K Gandhi

N Engl J Med 2016 Nov;375(18):1705-1707

From the National Patient Safety Foundation, Boston.

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http://dx.doi.org/10.1056/NEJMp1609208DOI Listing
November 2016

Patient Safety at the Crossroads.

JAMA 2016 May;315(17):1829-30

Centre for Quality Improvement and Patient Safety, University of Toronto, Toronto, Canada.

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http://dx.doi.org/10.1001/jama.2016.1759DOI Listing
May 2016

Effect of Pharmacist Counseling Intervention on Health Care Utilization Following Hospital Discharge: A Randomized Control Trial.

J Gen Intern Med 2016 May;31(5):470-7

Center for Health Services Research, Vanderbilt University, Nashville, TN, USA.

Background: Reduction in 30-day readmission rates following hospitalization for acute coronary syndrome (ACS) and acute decompensated heart failure (ADHF) is a national goal.

Objective: The aim of this study was to determine the effect of a tailored, pharmacist-delivered, health literacy intervention on unplanned health care utilization, including hospital readmission or emergency room (ER) visit, following discharge.

Design: Randomized, controlled trial with concealed allocation and blinded outcome assessors

Setting: Two tertiary care academic medical centers

Participants: Adults hospitalized with a diagnosis of ACS and/or ADHF.

Intervention: Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge

Main Measures: The primary outcome was time to first unplanned health care event, defined as hospital readmission or an ER visit within 30 days of discharge. Pre-specified analyses were conducted to evaluate the effects of the intervention by academic site, health literacy status (inadequate versus adequate), and cognition (impaired versus not impaired). Adjusted hazard ratios (aHR) and 95% confidence intervals (CI) are reported.

Key Results: A total of 851 participants enrolled in the study at Vanderbilt University Hospital (VUH) and Brigham and Women's Hospital (BWH). The primary analysis showed no statistically significant effect on time to first unplanned hospital readmission or ER visit among patients who received interventions compared to controls (aHR = 1.04, 95% CI 0.78-1.39). There was an interaction of treatment effect by site (p = 0.04 for interaction); VUH aHR = 0.77, 95% CI 0.51-1.15; BWH aHR = 1.44 (95% CI 0.95-2.12). The intervention reduced early unplanned health care utilization among patients with inadequate health literacy (aHR 0.41, 95% CI 0.17-1.00). There was no difference in treatment effect by patient cognition.

Conclusion: A tailored, pharmacist-delivered health literacy-sensitive intervention did not reduce post-discharge unplanned health care utilization overall. The intervention was effective among patients with inadequate health literacy, suggesting that targeted practice of pharmacist intervention in this population may be advantageous.
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http://dx.doi.org/10.1007/s11606-016-3596-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4835388PMC
May 2016

On the safe side.

Healthc Financ Manage 2015 Aug;69(8):94, 96-7

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August 2015

HTM Plays 'Critical Role' in Patient Safety, NPSF Leader Says.

Authors:
Tejal K Gandhi

Biomed Instrum Technol 2015 Jul-Aug;49(4):269-72

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http://dx.doi.org/10.2345/0899-8205-49.4.269DOI Listing
December 2015

Report of the AMIA EHR-2020 Task Force on the status and future direction of EHRs.

J Am Med Inform Assoc 2015 Sep 28;22(5):1102-10. Epub 2015 May 28.

Sparrow Health System, Lansing, MI and Department of Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA.

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http://dx.doi.org/10.1093/jamia/ocv066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5009932PMC
September 2015

Ambulatory Computerized Prescribing and Preventable Adverse Drug Events.

J Patient Saf 2016 06;12(2):69-74

From the *Siemens Health Services, Malvern, PA;, †Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital; ‡Harvard Medical School, Boston, MA; §National Library of Medicine VA Medical Informatics Fellow, Salt Lake City, UT; ∥Purdue University College of Pharmacy, Indianapolis, IN; ¶Regenstrief Institute, Indianapolis, IN; and **Harvard School of Public Health, Boston, MA.

Background: Adverse drug events (ADEs) represent a significant cause of injury in the ambulatory care setting. Computerized physician order entry reduces rates of serious medication errors that can lead to ADEs in the inpatient setting, but few studies have evaluated whether computerized prescribing in the ambulatory setting reduces preventable ADE rates in ambulatory care.

Objective: To determine the rates of preventable ADEs before and after the implementation of computerized prescribing with basic clinical decision support for ordering medications.

Design: Before-after study of ADE rates in practices implementing computer order entry.

Participants: Adult patients seeking care in primary care practices at academic medical centers in Boston, Massachusetts (n = 41,819), and Indianapolis, Indiana (n = 9128).

Main Measures: We attempted to standardize the medication-related decision support knowledge base provided at the 2 sites, although the electronic records and presentation layers used at the 2 sites differed. The primary outcome was preventable ADEs identified based on structured results or symptoms defined by extracting symptom concepts from provider notes; potential ADEs were a secondary outcome.

Results: Computerized prescribing did not significantly change the rate of preventable ADEs at either site. Compared with Boston practices, the rate of potential ADEs was more than seven-fold greater at Indianapolis (6.4/10,000 patient-months vs. 49.5/10,000 patient-months, P < 0.001). Computerized prescribing was associated with a 56% decrease in the potential ADE rate at Indianapolis (49.5 to 21.9/10,000 patient-months, P < 0.001) but a 104% increase at Boston (6.4 to 13.0/10,000 patient-months, P < 0.001). Preventable ADEs that occurred after computerized prescribing was implemented were due to patient education issues, physicians ignoring feedback from CDSS, and incomplete computerized knowledge base was incomplete (34%, 33%, and 33% in Indianapolis and 44%, 28%, and 28% in Boston).

Conclusions: The implementation of computerized prescribing in the ambulatory setting was not associated with any change in preventable ADEs but was associated with a decrease in potential ADEs at Indianapolis but an increase at Boston, although the absolute rate of ADEs was much lower in Boston.
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http://dx.doi.org/10.1097/PTS.0000000000000194DOI Listing
June 2016

Patient safety is not elective: a debate at the NPSF Patient Safety Congress.

BMJ Qual Saf 2015 Feb 19;24(2):162-6. Epub 2014 Nov 19.

National Patient Safety Foundation, Boston, Massachusetts, USA.

The opening keynote session of the 16th Annual National Patient Safety Foundation Patient Safety Congress, held 14-16 May 2014, featured a debate addressing the merits and challenges of accountability with respect to key issues in patient safety. The specific resolution debated was: Certain safety practices should be inviolable, and transgressions should result in penalties, potentially including fines, suspensions, and firing. The themes discussed in the debate are issues that healthcare professionals and leaders commonly struggle with in their day-to-day work. How do we draw a line between systems problems and personal failings? When should clinicians and staff be penalised for failing to follow a known safety protocol? The majority of those who listened to the live debate agreed that it is time to begin holding health professionals accountable when they wilfully or repeatedly violate policies or protocols put in place by their institutions to protect the safety of patients. This article summarises the debate as well as the questions and discussion generated by each side. A video of the original debate can be found at http://bit.ly/Npsf_debate.
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http://dx.doi.org/10.1136/bmjqs-2014-003429DOI Listing
February 2015

Creating a Fellowship Curriculum in Patient Safety and Quality.

Am J Med Qual 2016 Jan-Feb;31(1):27-30. Epub 2014 Sep 2.

Tufts Medical Center, Boston, MA.

The authors sought to create a curriculum suitable for a newly created clinical fellowship curriculum across Harvard Medical School-affiliated teaching hospitals as part of a newly created 2-year quality and safety fellowship program described in the companion article "Design and Implementation of the Harvard Fellowship in Patient Safety and Quality." The aim of the curriculum development process was to define, coordinate, design, and implement a set of essential skills for future physician-scholars of any specialty to lead operational quality and patient safety efforts. The process of curriculum development and the ultimate content are described in this article.
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http://dx.doi.org/10.1177/1062860614549012DOI Listing
February 2017

Design and Implementation of the Harvard Fellowship in Patient Safety and Quality.

Am J Med Qual 2016 Jan-Feb;31(1):22-6. Epub 2014 Sep 2.

Tufts Medical Center, Boston, MA.

The Harvard Fellowship in Patient Safety and Quality is a 2-year physician-oriented training program with a strong operational orientation, embedding trainees in the quality departments of participating hospitals. It also integrates didactic and experiential learning and offers the option of obtaining a master's degree in public health. The program focuses on methodologically rigorous improvement and measurement, with an emphasis on the development and implementation of innovative practice. The operational orientation is intended to foster the professional development of future quality and safety leaders. The purpose of this article is to describe the design and development of the fellowship.
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http://dx.doi.org/10.1177/1062860614549183DOI Listing
February 2017

A safe practice standard for barcode technology.

J Patient Saf 2015 Jun;11(2):89-99

From the *Brigham and Women's Hospital, Boston, Massachusetts; †Texas Medical Institute of Technology, Austin, Texas; and ‡Boston Medical Center, Boston, Massachusetts.

Objective: Safety advocates have identified barcode verification technology as an important tool to improve health-care practices.

Methods: We evaluated the evidence for the role of barcode technology in improving a wide range of medication safety outcomes across a broad range of settings. Important implementation issues were highlighted to guide standards for the safe adoption of barcode technology.

Results: Adverse drug events are common, occurring frequently in both inpatient and outpatient settings. Although approximately half of all preventable adverse drug events in inpatients result from medication errors arising from transcription, dispensing, and administration, these errors are far less likely to be caught than in any of the earlier stages of the medication use process and are therefore most amenable to improvement. When integrated with electronic medication administration records, barcode systems are associated with complete elimination of transcription errors. Furthermore, barcode-assisted dispensing systems are associated with 93% to 96% reductions in dispensing errors, and 85% reductions in potential adverse drug events in dispensing. Most studies have reported large and significant reductions in administration errors by up to 80% after implementation of barcode medication administration systems. Although most studies of barcode technology have been conducted in the adult inpatient setting, the limited data available also support their benefit in pediatric and outpatient settings.

Conclusions: There is growing evidence for the efficacy of barcode solutions in improving overall medication safety. Standards for the implementation of barcode technology are proposed.
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http://dx.doi.org/10.1097/PTS.0000000000000049DOI Listing
June 2015

An initiative to improve the management of clinically significant test results in a large health care network.

Jt Comm J Qual Patient Saf 2013 Nov;39(11):517-27

Brigham and Women's Hospital, Boston, USA.

Background: The failure of providers to communicate and follow up clinically significant test results (CSTR) is an important threat to patient safety. The Massachusetts Coalition for the Prevention of Medical Errors has endorsed the creation of systems to ensure that results can be received and acknowledged.

Methods: In 2008 a task force was convened that represented clinicians, laboratories, radiology, patient safety, risk management, and information systems in a large health care network with the goals of providing recommendations and a road map for improvement in the management of CSTR and of implementing this improvement plan during the sub-force sequent five years. In drafting its charter, the task broadened the scope from "critical" results to "clinically significant" ones; clinically significant was defined as any result that requires further clinical action to avoid morbidity or mortality, regardless of the urgency of that action.

Results: The task force recommended four key areas for improvement--(1) standardization of policies and definitions, (2) robust identification of the patient's care team, (3) enhanced results management/tracking systems, and (4) centralized quality reporting and metrics. The task force faced many challenges in implementing these recommendations, including disagreements on definitions of CSTR and on who should have responsibility for CSTR, changes to established work flows, limitations of resources and of existing information systems, and definition of metrics.

Conclusions: This large-scale effort to improve the communication and follow-up of CSTR in a health care network continues with ongoing work to address implementation challenges, refine policies, prepare for a new clinical information system platform, and identify new ways to measure the extent of this important safety problem.
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http://dx.doi.org/10.1016/s1553-7250(13)39068-0DOI Listing
November 2013

Using an Objective Structured Clinical Examination to test adherence to Joint Commission National Patient Safety Goal--associated behaviors.

Jt Comm J Qual Patient Saf 2012 Sep;38(9):414-8

Department of Surgery, Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, USA.

Background: A study was conducted at a tertiary care academic medical center to assess a simulation-based, single-station Objective Structured Clinical Examination (OSCE) designed to evaluate intern trainees' familiarity with and adherence to behaviors associated with Joint Commission National Patient Safety Goals and The Joint Commission Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery.

Method: Subjects were interns, from all disciplines, completing basic skills training during intern orientation. The OSCE scenario was designed to assess 13 behaviors associated with four National Patient Safety Goals (1, 2, 3, and 7) from 2009 and 2010 and the Universal Protocol. Sessions were digitally recorded and independently reviewed by two observers, who scored behaviors using a standardized score sheet. Behaviors were assigned point values and tabulated for all trainees. Kappa coefficient was calculated to assess interrater reliability.

Results: One-hundred eleven (74.5%) of 149 interns completed the station. The average time to completion was 6.9 minutes (standard deviation [SD] 1.8; range, 3.5-12.6). Interns scored an average of 9.5 points (SD, 4.7; range, 2-20; mode, 8) of 26. The interrater reliability for the two reviewers was 0.9. Interns most frequently requested chlorhexidine to sterilize the patient's skin (98.2% of interns demonstrated); identifying an unlabeled medication vial as inappropriate for use was the most frequently missed item (8.1% of interns demonstrated).

Conclusions: Behaviors related to tenets of patient safety and quality care can be assessed using a simple to design and execute OSCE. Using simulation to test behaviors associated with the National Patient Safety Goals may be a desirable adjunct to traditional simple knowledge-based tests.
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http://dx.doi.org/10.1016/s1553-7250(12)38053-7DOI Listing
September 2012

Adverse drug events caused by serious medication administration errors.

BMJ Qual Saf 2012 Nov 12;21(11):933-8. Epub 2012 Jul 12.

Division of General Medicine and Primary Care, Brigham & Women's Hospital, 1620 Tremont St, Boston, MA 02120, USA.

Objective: To determine how often serious or life-threatening medication administration errors with the potential to cause harm (potential adverse drug events) result in actual harm (adverse drug events (ADEs)) in the hospital setting.

Design: Retrospective chart review of clinical events following observed medication administration errors.

Background: Medication errors are common at the medication administration stage for inpatients. While many errors can cause harm, it is unclear exactly how often.

Methods: In a previous study where 14 041 medication administrations were directly observed, 1271 medication administration errors were discovered, of which 133 had the potential to cause serious or life-threatening harm and were considered serious or life-threatening potential adverse drug events. As a follow-up, clinical reviewers conducted detailed chart review of serious or life-threatening potential ADEs to determine if they caused an ADE. Reviewers assessed severity of the ADE and attribution to the error.

Results: Ten (7.5% (95% CI 6.98 to 8.01)) actual ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% (95% CI 2.12 to 3.6)) of serious or life threatening potential ADEs led to serious or life threatening ADEs. Half of the ADEs were caused by dosage or monitoring errors for anti-hypertensives.

Conclusions: Unintercepted potential ADEs at the medication administration stage can cause serious patient harm. At hospitals where 6 million doses are administered per year, about 4000 preventable ADEs would be attributable to medication administration errors annually.
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http://dx.doi.org/10.1136/bmjqs-2012-000946DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4454622PMC
November 2012

Effect of a pharmacist intervention on clinically important medication errors after hospital discharge: a randomized trial.

Ann Intern Med 2012 Jul;157(1):1-10

Department of Medicine, Vanderbilt University, 1215 21st Avenue South, Suite 6000 Medical Center East, Nashville, TN 37232, USA.

Background: Clinically important medication errors are common after hospital discharge. They include preventable or ameliorable adverse drug events (ADEs), as well as medication discrepancies or nonadherence with high potential for future harm (potential ADEs).

Objective: To determine the effect of a tailored intervention on the occurrence of clinically important medication errors after hospital discharge.

Design: Randomized, controlled trial with concealed allocation and blinded outcome assessors. (ClinicalTrials.gov registration number: NCT00632021)

Setting: Two tertiary care academic hospitals.

Patients: Adults hospitalized with acute coronary syndromes or acute decompensated heart failure.

Intervention: Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge.

Measurements: The primary outcome was the number of clinically important medication errors per patient during the first 30 days after hospital discharge. Secondary outcomes included preventable or ameliorable ADEs, as well as potential ADEs.

Results: Among 851 participants, 432 (50.8%) had 1 or more clinically important medication errors; 22.9% of such errors were judged to be serious and 1.8% life-threatening. Adverse drug events occurred in 258 patients (30.3%) and potential ADEs in 253 patients (29.7%). The intervention did not significantly alter the per-patient number of clinically important medication errors (unadjusted incidence rate ratio, 0.92 [95% CI, 0.77 to 1.10]) or ADEs (unadjusted incidence rate ratio, 1.09 [CI, 0.86 to 1.39]). Patients in the intervention group tended to have fewer potential ADEs (unadjusted incidence rate ratio, 0.80 [CI, 0.61 to 1.04]).

Limitation: The characteristics of the study hospitals and participants may limit generalizability.

Conclusion: Clinically important medication errors were present among one half of patients after hospital discharge and were not significantly reduced by a health-literacy-sensitive, pharmacist-delivered intervention.

Primary Funding Source: National Heart, Lung, and Blood Institute.
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http://dx.doi.org/10.7326/0003-4819-157-1-201207030-00003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3575734PMC
July 2012

Factors associated with radiologists' adherence to Fleischner Society guidelines for management of pulmonary nodules.

J Am Coll Radiol 2012 Jul;9(7):468-73

Center for Evidence-Based Imaging and Department of Radiology, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts 02445, USA.

Purpose: In 2005, the Fleischner Society guidelines (FSG) for managing pulmonary nodules detected on CT scans were published. The aim of this study was to evaluate adherence to the FSG, adjusting for demographic and clinical variables that may contribute to adherence.

Methods: Radiology reports were randomly obtained for 1,100 chest and abdominal CT scans performed between January and June 2010 in a tertiary hospital's emergency department and outpatient clinics. An automated document retrieval system using natural language processing was used to identify patients with pulmonary nodules from the data set. Features relevant to evaluating variation in adherence to the FSG, including age, sex, race, nodule size, and scan site (eg, the emergency department) and type, were extracted by manual review from reports retrieved using natural language processing. All variables were entered into a logistic regression model.

Results: Three hundred fifteen reports were identified to have pulmonary nodules, 75 of which were for patients with concurrent malignancies or aged < 35 years. Of the remaining 240 reports, 34% of recommendations for pulmonary nodules were adherent to the FSG. Nodule size demonstrated an association with guideline adherence, with adherence highest in the >4-mm to 6-mm nodule group (P = .04) and progressively diminishing for smaller and bigger nodules.

Conclusions: Pulmonary nodules are prevalent findings on chest and abdominal CT scans. Although most radiologists recommend follow-up imaging for these findings, recommendations for pulmonary nodules were consistent with the FSG in 34% of radiology reports. Nodule size demonstrated an association with guideline adherence, after adjusting for key variables.
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http://dx.doi.org/10.1016/j.jacr.2012.03.009DOI Listing
July 2012

Cognitive errors and logistical breakdowns contributing to missed and delayed diagnoses of breast and colorectal cancers: a process analysis of closed malpractice claims.

J Gen Intern Med 2012 Nov 19;27(11):1416-23. Epub 2012 May 19.

Division of General Medicine and Primary Care, Department of Medicine, Brigham & Women's Hospital, 3/F 1620 Tremont Street, Boston, MA, 02120, USA.

Purpose: To erform a process analysis of missed and delayed diagnoses of breast and colorectal cancers to identify: (1) the cognitive and logistical factors that lead to these diagnostic errors, and (2) prevention strategies.

Methods: Using 56 cases (43 breast, 13 colon) of missed and delayed diagnosis, we performed structured analyses to identify specific points in the diagnostic process in which errors occurred. Each error was classified as either a cognitive error or logistical breakdown. Finally, two physician-investigators identified strategies to prevent the errors in each case.

Results: Virtually all cases involved one or more cognitive errors (53/56, 95 %) and approximately half (31/56, 55 %) involved logistical breakdowns. The clinical activity most prone to cognitive error was the selection of the diagnostic strategy, both during the office visit (25/56, 45 %) and during interpretation of test results (22/50, 44 %). Arrangement of follow-up visits with a primary care physician (8/29, 28 %) or specialist physician (7/29, 26 %) were especially prone to logistical breakdowns. Adherence to current clinical guidelines could have prevented at least one error in 66 % of cases and assistance from a patient advocate could have prevented at least one error in 48 % of cases.

Conclusions: Cognitive errors and logistical breakdowns are common among missed and delayed diagnoses of breast and colorectal cancers. Prevention strategies should focus on ensuring improving the effectiveness and use of clinical guidelines in the selection of diagnostic strategy, both during office visits and when interpreting test results. Tools to facilitate communication and to ensure that follow-up visits occur should also be considered.
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http://dx.doi.org/10.1007/s11606-012-2107-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475819PMC
November 2012

Effects of an online personal health record on medication accuracy and safety: a cluster-randomized trial.

J Am Med Inform Assoc 2012 Sep-Oct;19(5):728-34. Epub 2012 May 3.

Division of General Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts 02120-1613, USA.

Objective: To determine the effects of a personal health record (PHR)-linked medications module on medication accuracy and safety.

Design: From September 2005 to March 2007, we conducted an on-treatment sub-study within a cluster-randomized trial involving 11 primary care practices that used the same PHR. Intervention practices received access to a medications module prompting patients to review their documented medications and identify discrepancies, generating 'eJournals' that enabled rapid updating of medication lists during subsequent clinical visits.

Measurements: A sample of 267 patients who submitted medications eJournals was contacted by phone 3 weeks after an eligible visit and compared with a matched sample of 274 patients in control practices that received a different PHR-linked intervention. Two blinded physician adjudicators determined unexplained discrepancies between documented and patient-reported medication regimens. The primary outcome was proportion of medications per patient with unexplained discrepancies.

Results: Among 121,046 patients in eligible practices, 3979 participated in the main trial and 541 participated in the sub-study. The proportion of medications per patient with unexplained discrepancies was 42% in the intervention arm and 51% in the control arm (adjusted OR 0.71, 95% CI 0.54 to 0.94, p=0.01). The number of unexplained discrepancies per patient with potential for severe harm was 0.03 in the intervention arm and 0.08 in the control arm (adjusted RR 0.31, 95% CI 0.10 to 0.92, p=0.04).

Conclusions: When used, concordance between documented and patient-reported medication regimens and reduction in potentially harmful medication discrepancies can be improved with a PHR medication review tool linked to the provider's medical record.

Trial Registration Number: This study was registered at ClinicalTrials.gov (NCT00251875).
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http://dx.doi.org/10.1136/amiajnl-2011-000723DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3422826PMC
January 2013

Randomized controlled trial of health maintenance reminders provided directly to patients through an electronic PHR.

J Gen Intern Med 2012 Jan 9;27(1):85-92. Epub 2011 Sep 9.

Brigham & Women's Hospital, Boston, MA 02115, USA.

Background: Provider and patient reminders can be effective in increasing rates of preventive screenings and vaccinations. However, the effect of patient-directed electronic reminders is understudied.

Objective: To determine whether providing reminders directly to patients via an electronic Personal Health Record (PHR) improved adherence to care recommendations.

Design: We conducted a cluster randomized trial without blinding from 2005 to 2007 at 11 primary care practices in the Partners HealthCare system.

Participants: A total of 21,533 patients with access to a PHR were invited to the study, and 3,979 (18.5%) consented to enroll.

Interventions: Patients in the intervention arm received health maintenance (HM) reminders via a secure PHR "eJournal," which allowed them to review and update HM and family history information. Patients in the active control arm received access to an eJournal that allowed them to input and review information related to medications, allergies and diabetes management.

Main Measures: The primary outcome measure was adherence to guideline-based care recommendations.

Key Results: Intention-to-treat analysis showed that patients in the intervention arm were significantly more likely to receive mammography (48.6% vs 29.5%, p = 0.006) and influenza vaccinations (22.0% vs 14.0%, p = 0.018). No significant improvement was observed in rates of other screenings. Although Pap smear completion rates were higher in the intervention arm (41.0% vs 10.4%, p < 0.001), this finding was no longer significant after excluding women's health clinics. Additional on-treatment analysis showed significant increases in mammography (p = 0.019) and influenza vaccination (p = 0.015) for intervention arm patients who opened an eJournal compared to control arm patients, but no differences for any measure among patients who did not open an eJournal.

Conclusions: Providing patients with HM reminders via a PHR may be effective in improving some elements of preventive care.
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http://dx.doi.org/10.1007/s11606-011-1859-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3250545PMC
January 2012
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