Patient safety research has focused largely on hospital settings despite the fact that in many countries, the majority of patient contacts are in primary care. The knowledge base about patient safety in primary care is developing but sparse and diagnostic error is a relatively understudied and an unmeasured area of patient safety. Diagnostic error rates vary according to how ‘error’ is defined but one suggested hallmark is clear evidence of ‘missed opportunity’ (MDOs) makes a correct or timely diagnosis to prevent them. While there is no agreed definition or method of measuring MDOs, retrospective manual chart or patient record reviews are a ‘gold standard’. This study protocol aims to (1) determine the incidence of MDOs in English general practice, (2) identify the confounding and contributing factors that lead to MDOs and (3) determine the (potential) impact of the detected MDOs on patients.
We plan to conduct a two-phase retrospective review of electronic health records in the Greater Manchester (GM) area of the UK. In the first phase, clinician reviewers will calibrate their performance in identifying and assessing MDOs against a gold standard ‘primary reviewer’ through the use of ‘double’ reviews of records. The findings will enable a preliminary estimate of the incidence of MDOs in general practice, which will be used to calculate the number of records to be reviewed in the second phase in order to estimate the true incidence of MDO in general practice. A sample of 15 general practices is required for phase 1 and up to 35 practices for phase 2. In each practice, the sample will consist of 100 patients aged ≥18 years on 1 April 2013 who have attended a face-to-face ‘index consultation’ between 1 April 2013 and 31 March 2015. The index consultation will be selected randomly from each unique patient record, occurring between 1 July 2013 and 30 June 2014.
There are no reliable estimates of safety problems related to diagnosis in English general practice. This study will lay the foundation for safety improvements in this area by providing a more reliable estimate of MDOs, their impact and their contributory factors.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0296-z) contains supplementary material, which is available to authorized users.
Patient safety; Primary care; Diagnoses; Missed diagnostic opportunities; Diagnostic error; General practice
We conducted a systematic review to determine the effect of providing patients access to their medical records (electronic or paper-based) on healthcare quality, as defined by measures of safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity.
Articles indexed in PubMed from January 1970 to January 2012 were reviewed. Twenty-seven English-language controlled studies were included. Outcomes were categorized as measures of effectiveness (n=19), patient-centeredness (n=16), and efficiency (n=2); no study addressed safety, timeliness, or equity.
Outcomes were equivocal with respect to several aspects of effectiveness and patient-centeredness. Efficiency outcomes in terms of frequency of in-person and telephone encounters were mixed. Access to health records appeared to enhance patients’ perceptions of control and reduced or had no effect on patient anxiety.
Although few positive findings generally favored patient access, the literature is unclear on whether providing patients access to their medical records improves quality.
Patient Access; Personal Health Record
Electronic health record systems (EHRs) can improve safety and reliability of health care, but they can also introduce new vulnerabilities by failing to accommodate changes within a dynamic EHR-enabled health care system. Continuous assessment and improvement is thus essential for achieving resilience in EHR-enabled health care systems. Given the rapid adoption of EHRs by many organizations that are still early in their experiences with EHR safety, it is important to understand practices for maintaining resilience used by organizations with a track record of success in EHR use. We conducted interviews about safety practices with 56 key informants (including information technology managers, chief medical information officers, physicians, and patient safety officers) at two large health care systems recognized as leaders in EHR use. We identified 156 references to resilience-related practices from 41 informants. Framework analysis generated five categories of resilient practices: (a) sensitivity to dynamics and interdependencies affecting risks, (b) basic monitoring and responding practices, (c) management of practices and resources for monitoring and responding, (d) sensitivity to risks beyond the horizon, and (e) reflecting on risks with the safety and quality control process itself. The categories reflect three functions that facilitate resilience: reflection, transcending boundaries, and involving sharp-end practitioners in safety management.
health care delivery; domains; information systems; resilience engineering; topics; naturalistic decision making
Patients are increasingly using the Internet to communicate with health care providers and access general and personal health information. Missed test results have been identified as a critical safety issue with studies showing up to 75% of tests for emergency department (ED) patients not being followed-up. One strategy that could reduce the likelihood of important results being missed is for ED patients to have direct access to their test results. This could be achieved electronically using a patient portal tied to the hospital’s electronic medical record or accessed from the relevant laboratory information system. Patients have expressed interest in accessing test results directly, but there have been no reported studies on emergency physicians’ opinions.
The aim was to explore emergency physicians’ current practices of test result notification and attitudes to direct patient notification of clinically significant abnormal and normal test results.
A cross-sectional survey was self-administered by senior emergency physicians (site A: n=50; site B: n=39) at 2 large public metropolitan teaching hospitals in Australia. Outcome measures included current practices for notification of results (timing, methods, and responsibilities) and concerns with direct notification.
The response rate was 69% (61/89). More than half of the emergency physicians (54%, 33/61) were uncomfortable with patients receiving direct notification of abnormal test results. A similar proportion (57%, 35/61) was comfortable with direct notification of normal test results. Physicians were more likely to agree with direct notification of normal test results if they believed it would reduce their workload (OR 5.72, 95% CI 1.14-39.76). Main concerns were that patients could be anxious (85%, 52/61), confused (92%, 56/61), and lacking in the necessary expertise to interpret their results (90%, 55/61).
Although patients’ direct access to test results could serve as a safety net reducing the likelihood of abnormal results being missed, emergency physicians’ concerns need further exploration: which results are suitable and the timing and method of direct release to patients. Methods of access, including secure Web-based patient portals with drill-down facilities providing test descriptions and result interpretations, or laboratories sending results directly to patients, need evaluation to ensure patient safety is not compromised and the processes fit with ED clinician and laboratory work practices and patient needs.
Internet; patient safety; electronic health records; patient empowerment; diagnostic tests; emergency care; radiology
Tie overdressing is commonly used to secure the graft against the raw surface and prevent loss due to of hematoma or seroma. A conventional tie over dressing with silk sutures, is a useful method of securing the graft to raw area. Refixation is difficult when repeated tie over dressings are needed. We assessed a low cost repeated tie over dressing method using sterile sample collection containers and silk suture threads in eight patients. After the graft is applied on the bed, tie-over stitches are taken, and paraffin gauze is applied over with adequate padding; the tie over sutures are passed through the container and the lid is tightened over it to complete the dressing. The lid can be unscrewed easily at any time to inspect the graft and can be easily reapplied in the outpatient department. The skin graft take in all the patients was complete without any seroma or hematoma. A novel and low-cost tie over dressing that enables simple fixation of the dressing, to maintain proper position of grafts that require repeated fixation is reported here.
Low cost; novel; skin graft; tie-over dressing
Systemic issues can adversely affect the diagnostic process. Many system-related barriers can be masked by ‘resilient’ actions of frontline providers (ie, actions supporting the safe delivery of care in the presence of pressures that the system cannot readily adapt to). We explored system barriers and resilient actions of primary care providers (PCPs) in the diagnostic evaluation of cancer.
We conducted a secondary data analysis of interviews of PCPs involved in diagnostic evaluation of 29 lung and colorectal cancer cases. Cases covered a range of diagnostic timeliness and were analyzed to identify barriers for rapid diagnostic evaluation, and PCPs’ actions involving elements of resilience addressing those barriers. We rated these actions according to whether they were usual or extraordinary for typical PCP work.
Resilient actions and associated barriers were found in 59% of the cases, in all ranges of timeliness, with 40% involving actions rated as beyond typical. Most of the barriers were related to access to specialty services and coordination with patients. Many of the resilient actions involved using additional communication channels to solicit cooperation from other participants in the diagnostic process.
Diagnostic evaluation of cancer involves several resilient actions by PCPs targeted at system deficiencies. PCPs’ actions can sometimes mitigate system barriers to diagnosis, and thereby impact the sensitivity of ‘downstream’ measures (eg, delays) in detecting barriers. While resilient actions might enable providers to mitigate system deficiencies in the short run, they can be resource intensive and potentially unsustainable. They complement, rather than substitute for, structural remedies to improve system performance. Measures to detect and fix system performance issues targeted by these resilient actions could facilitate diagnostic safety.
patient safety; systems resilience; quality and safety measurements; test results; care delays
Electronic health record (EHR)-based alerts can facilitate transmission of test results to healthcare providers, helping ensure timely and appropriate follow-up. However, failure to follow-up on abnormal test results (missed test results) persists in EHR-enabled healthcare settings. We aimed to identify contextual factors associated with facility-level variation in missed test results within the Veterans Affairs (VA) health system.
Design, setting and participants
Based on a previous survey, we categorised VA facilities according to primary care providers’ (PCPs’) perceptions of low (n=20) versus high (n=20) risk of missed test results. We interviewed facility representatives to collect data on several contextual factors derived from a sociotechnical conceptual model of safe and effective EHR use. We compared these factors between facilities categorised as low and high perceived risk, adjusting for structural characteristics.
Facilities with low perceived risk were significantly more likely to use specific strategies to prevent alerts from being lost to follow-up (p=0.0114). Qualitative analysis identified three high-risk scenarios for missed test results: alerts on tests ordered by trainees, alerts ‘handed off’ to another covering clinician (surrogate clinician), and alerts on patients not assigned in the EHR to a PCP. Test result management policies and procedures to address these high-risk situations varied considerably across facilities.
Our study identified several scenarios that pose a higher risk for missed test results in EHR-based healthcare systems. In addition to implementing provider-level strategies to prevent missed test results, healthcare organisations should consider implementing monitoring systems to track missed test results.
Elecronic Health Records; Missed Test Results; Patient Follow-up; Social-Technical Model; Patient Safety; Diagnostic Errors
Delays in diagnosis and treatment are widely considered to be threats to outpatient safety. However, few studies have identified and described what factors contribute to delays that might result in patient harm in the outpatient setting. We analyzed 111 root cause analysis reports that investigated such delays and were submitted to the Veterans Affairs National Center for Patient Safety in the period 2005–12. The most common contributing factors noted in the reports included coordination problems resulting from inadequate follow-up planning, delayed scheduling for unspecified reasons, inadequate tracking of test results, and the absence of a system to track patients in need of short-term follow-up. Other contributing factors were team-level decision making problems resulting from miscommunication of urgency between providers and providers' lack of awareness of or knowledge about a patient's situation; and communication failures among providers, patients, and other health care team members. Our findings suggest that to support care goals in the Affordable Care Act and the National Quality Strategy, even relatively sophisticated electronic health record systems will require enhancements. At the same time, policy initiatives should support programs to implement, and perhaps reward the use of, more rigorous interprofessional teamwork principles to improve outpatient communication and coordination.
A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system.
The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports.
We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or ‘hidden dependencies’ within the EHR.
EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after ‘go-live’ and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA.
Because EHR-related safety concerns have complex sociotechnical origins, institutions with long-standing as well as recent EHR implementations should build a robust infrastructure to monitor and learn from them.
Electronic Health Records; sociotechnical; reporting systems; medical errors; human factors; patients safety
diagnostic errors; patient safety; test results; care delays; health information technology; primary care; electronic health records; usability
Diagnostic errors are an understudied aspect of ambulatory patient safety.
To determine the types of diseases missed and the diagnostic process involved in the cases of confirmed diagnosis errors in primary care settings and to determine whether record reviews could shed light on potential contributory factors to inform future interventions.
We reviewed medical records of diagnostic errors detected at two sites through electronic health records-based triggers. Triggers were based on patterns of patients’ unexpected return visits after an initial primary care “index” visit.
A larger urban Veterans Affairs facility and a large integrated private health care system.
Our study focused on 190 unique instances of diagnostic errors detected in primary care visits between October 1, 2006, and September 30, 2007.
Main Outcome Measures
Through medical record reviews, we collected data on presenting symptoms at the index visit, types of diagnoses missed, process breakdowns, potential contributory factors, and potential for harm from errors.
In 190 cases, a total of 68 unique diagnoses were missed. Most missed diagnoses were common conditions in primary care, with pneumonia (6.7%), decompensated congestive heart failure (5.7%), acute renal failure (5.3%), cancer (primary) (5.3%), and urinary tract infection or pyelonephritis (4.8%) being most common. Process breakdowns most frequently involved the patient-practitioner clinical encounter (78.9%) but were also related to referrals (19.5%), patient-related factors (16.3%), follow-up and tracking of diagnostic information (14.7%), and performance and interpretation of diagnostic tests (13.6%). A total of 43.7% of cases involved more than one of these processes. Patient- practitioner encounter breakdowns were primarily related to problems with history-taking (56.3%), examination (47.4%), and/or ordering diagnostic tests for further work-up (57.4%). Most errors were associated with potential for moderate-to-severe harm.
Conclusions and Relevance
Diagnostic errors identified in our study involved a large variety of common diseases and had significant potential for harm. Most errors were related to process breakdowns in the patient-practitioner clinical encounter. Preventive interventions should target common contributory factors across diagnoses, especially those that involve data gathering and synthesis in the patient- practitioner encounter.
diagnostic errors; patient safety; follow-up; primary care; electronic health records
Background and Objective
On March 11, 2009, the Veterans Health Administration (VA) implemented an electronic health record (EHR)-based intervention that required all pathology results to be transmitted to ordering providers via mandatory automated notifications. We examined the impact of this intervention on improving follow-up of abnormal outpatient pathology results.
Research Design and Subjects
We extracted pathology reports from the EHR of two VA sites. From 16,738 pre- and 17,305 post-intervention reports between 09/01/2008 and 09/30/2009, we randomly selected about 5% and evaluated follow-up outcomes using a standardized chart review instrument. Documented responses to the alerted report (e.g., ordering follow-up tests or referrals, notifying patients, and prescribing/changing treatment) were recorded.
Primary outcome measures included proportion of timely follow-up responses (within 30 days) and median time to direct response for abnormal reports.
Of 816 pre- and 798 post-intervention reports reviewed, 666 (81.6%) and 688 (86.2%) were abnormal. Overall, there was no apparent intervention effect on timely follow-up (69% vs. 67.1%;p=0.4) or median time to direct response (8 days vs. 8 days; p=0.7). However, logistic regression uncovered a significant intervention effect (pre-intervention OR, 0.7; 95%CI 0.5-1.0) after accounting for site-specific differences in follow-up, with a lower likelihood of timely follow-up at one site (OR,0.4; 95%CI 0.2-0.7).
An electronic intervention to improve test result follow-up at two VA institutions using the same EHR was found effective only after accounting for certain local contextual factors. Aggregating the effect of EHR interventions across different institutions and EHRs without controlling for contextual factors might underestimate their potential benefits.
Anatomic pathology; electronic health record; communication; follow-up; post-analytic phase
Delays in colorectal cancer (CRC) diagnosis are one of the most common reasons for malpractice claims and lead to poor outcomes. However, they are not well studied.
We used a mixed quantitative-qualitative approach to analyze post-referral colonoscopy delays in CRC patients and explored referring physician’s perception of processes surrounding these delays.
Two physician-raters conducted independent electronic health record reviews of new CRC cases in a large integrated safety-net system to determine post-referral colonoscopy delays, which we defined as failures to perform colonoscopy within 60 days of referral for an established indication(s). To explore perceptions of colonoscopy processes, we conducted semi-structured interviews with a sample of primary care physicians (PCPs) and used a content analysis approach.
Of 104 CRC cases that met inclusion criteria, reviewers agreed on the presence of post-referral colonoscopy delays in 35 (33.7%) cases; κ = 0.99 (95% CI, 0.83–0.99). The median time between first referral and completion of colonoscopy was 123.0 days (range 62.0–938.0; IQR=90.0 days). In about two-thirds of instances (64.8%), the reason for delay was a delayed future appointment with the gastroenterology service. On interviews, PCPs attributed long delays in scheduling to reduced endoscopic capacity and inefficient processes related to colonoscopy referral and scheduling, including considerable ambiguity regarding referral guidelines. Many suggested that navigation models be applied to streamline CRC diagnosis.
Post-referral delays in CRC diagnosis are potentially preventable. A comprehensive mixed-methods methodology might be useful for others to identify the steps in the diagnostic process that are in most need for improvement.
Diagnostic delays; colorectal cancer; primary care; referrals; practice patterns
Resident duty-hour regulations potentially shift workload from resident to attending physicians. We sought to understand how current or future regulatory changes might impact safety in academic pediatric and neonatal intensive care units (ICUs).
US academic pediatric and neonatal ICUs
Attending pediatric and neonatal intensivists
We evaluated perceptions on four ICU safety-related risk measures potentially affected by current duty-hour regulations: 1) Attending physician and resident fatigue, 2) Attending physician work-load, 3) Errors (self-reported rates by attending physicians or perceived resident error rates), and 4) Safety culture. We also evaluated perceptions of how these risks would change with further duty hour restrictions.
Measurements and Main Results
We administered our survey between February and April 2010 to 688 eligible physicians, of which 360 (52.3%) responded. Most believed that resident error rates were unchanged or worse (91.9%) and safety culture was unchanged or worse (84.4%) with current duty-hour regulations. Of respondents, 61.9% believed their own work-hours providing direct patient care increased and 55.8% believed they were more fatigued while providing direct patient care. Most (85.3%) perceived no increase in their own error rates currently, but in the scenario of further reduction in resident duty-hours, over half (53.3%) believed that safety culture would worsen and a significant proportion (40.3%) believed that their own error rates would increase.
Pediatric intensivists do not perceive improved patient safety from current resident duty hour restrictions. Policies to further restrict resident duty hours should consider unintended consequences of worsening certain aspects of ICU safety.
Resident duty hours; graduate medical education; Patient Safety; Intensive Care; Pediatrics; Medical Errors
Although misdiagnosis in the outpatient setting leads to significant patient harm and wasted resources, it is not well studied. We surveyed primary care physicians (PCPs) about barriers to timely diagnosis in the outpatient setting and assessed their perceptions of diagnostic difficulty.
We conducted a survey of general internists and family physicians practicing in an integrated health system across 10 geographically dispersed states in 2005. The survey elicited information on key cognitive failures (such as in clinical knowledge or judgment) for a specific case, and solicited strategies for reducing diagnostic delays. Content analysis was used to categorize cognitive failures and strategies for improvement. We examined the extent and predictors of diagnostic difficulty, defined as reporting >5% patients difficult to diagnose.
Of 1817 physicians surveyed, 1054 (58%) responded; 848 (80%) respondents primarily practiced in outpatient settings and had an assigned patient panel (inclusion sample). Inadequate knowledge (19.9%) was the most commonly reported cognitive factor. Half reported >5% of their patients were difficult to diagnose; more experienced physicians reported less diagnostic difficulty. In adjusted analyses, problems with information processing (information availability and time to review it) and the referral process, were associated with greater diagnostic difficulty. Strategies for improvement most commonly involved workload issues (panel size, non-visit tasks).
PCPs report a variety of reasons for diagnostic difficulties in primary care practice. In our study, knowledge gaps appear to be a prominent concern. Interventions that address these gaps as well as practice level issues such as time to process diagnostic information and better subspecialty input may reduce diagnostic difficulties in primary care.
diagnostic error; missed and delayed diagnosis; primary care; cognitive errors; patient safety
To explore perceptions of primary care physicians’ (PCPs) and oncologists’ roles, responsibilities, and patterns of communication related to shared cancer care in three integrated health systems that used electronic health records (EHRs).
We conducted semi-structured interviews with ten early stage colorectal cancer patients and fourteen oncologists and PCPs. Sample sizes were determined by thematic saturation. Dominant themes and codes were identified and subsequently applied to all transcripts.
Physicians reported that EHRs improved communication within integrated systems, but communication with physicians outside their system was still difficult. PCPs expressed uncertainty about their role during cancer care, even though medical oncologists emphasized the importance of co-morbidity control during cancer treatment. Both patients and physicians described additional roles for PCPs, including psychological distress support and behavior modification.
Integrated systems that use EHRs likely facilitate shared cancer care through improved PCP-oncologist communication. However, strategies to facilitate a more active role for PCPs in managing co-morbidities, psychological distress and behavior modification, as well as to overcome communication challenges between physicians not practicing within the same integrated system, are still needed to improve shared cancer care.
Diagnostic errors in primary care are harmful but poorly studied. To facilitate understanding of diagnostic errors in real-world primary care settings using electronic health records (EHRs), this study explored the use of the Situational Awareness (SA) framework from aviation human factors research.
A mixed-methods study was conducted involving reviews of EHR data followed by semi-structured interviews of selected providers from two institutions in the US. The study population included 380 consecutive patients with colorectal and lung cancers diagnosed between February 2008 and January 2009. Using a pre-tested data collection instrument, trained physicians identified diagnostic errors, defined as lack of timely action on one or more established indications for diagnostic work-up for lung and colorectal cancers. Twenty-six providers involved in cases with and without errors were interviewed. Interviews probed for providers' lack of SA and how this may have influenced the diagnostic process.
Of 254 cases meeting inclusion criteria, errors were found in 30 (32.6%) of 92 lung cancer cases and 56 (33.5%) of 167 colorectal cancer cases. Analysis of interviews related to error cases revealed evidence of lack of one of four levels of SA applicable to primary care practice: information perception, information comprehension, forecasting future events, and choosing appropriate action based on the first three levels. In cases without error, the application of the SA framework provided insight into processes involved in attention management.
A framework of SA can help analyze and understand diagnostic errors in primary care settings that use EHRs.
diagnostic error; decision-making; patient safety; primary care; medical errors; human factors; cancer; electronic health records; diagnostic delays
Diagnostic errors in primary care are harmful but difficult to detect. We tested an electronic health record (EHR)-based method to detect diagnostic errors in routine primary care practice.
We conducted a retrospective study of primary care visit records “triggered” through electronic queries for possible evidence of diagnostic errors: Trigger 1: A primary care index visit followed by unplanned hospitalization within 14 days; and Trigger 2: A primary care index visit followed by ≥ 1 unscheduled visit(s) within 14 days. Control visits met neither criterion. Electronic trigger queries were applied to EHR repositories at two large healthcare systems between October 1, 2006 and September 30, 2007. Blinded physician-reviewers independently determined presence or absence of diagnostic errors in selected triggered and control visits. An error was defined as a missed opportunity to make or pursue the correct diagnosis when adequate data was available at the index visit. Disagreements were resolved by an independent third reviewer.
Queries were applied to 212,165 visits. On record review, we found diagnostic errors in 141 of 674 Trigger 1-positive records (PPV=20.9%, 95% CI, 17.9%-24.0%) and 36 of 669 Trigger 2-positive records (PPV=5.4%, 95% CI, 3.7%-7.1%). The control PPV of 2.1% (95% CI, 0.1%-3.3%) was significantly lower than that of both triggers (P ≤ .002). Inter-rater reliability was modest, though higher than in comparable previous studies (κ = 0.37 [95% CI=0.31-0.44]).
While physician agreement on diagnostic error remains low, an EHR-facilitated surveillance methodology could be useful for gaining insight into the origin of these errors.
diagnostic errors; primary care; patient safety; electronic health records; triggers; automated surveillance; error detection
Electronic health records (EHRs) have potential quality and safety benefits. However, reports of EHR-related safety hazards are now emerging. The Office of the National Coordinator (ONC) for Health Information Technology (HIT) recently sponsored an Institute of Medicine committee to evaluate how HIT use affects patient safety. In this paper, we propose the creation of a national EHR oversight program to provide dedicated surveillance of EHR-related safety hazards and to promote learning from identified errors, close calls, and adverse events. The program calls for data gathering, investigation/analysis and regulatory components. The first two functions will depend on institution-level EHR safety committees that will investigate all known EHR-related adverse events and near-misses and report them nationally using standardized methods. These committees should also perform routine safety self-assessments to proactively identify new risks. Nationally, we propose the long-term creation of a centralized, non-partisan board with an appropriate legal and regulatory infrastructure to ensure the safety of EHRs. We discuss the rationale of the proposed oversight program and its potential organizational components and functions. These include mechanisms for robust data collection and analyses of all safety concerns using multiple methods that extend beyond reporting; multidisciplinary investigation of selected high-risk safety events; and enhanced coordination with other national agencies in order to facilitate broad dissemination of hazards information. Implementation of this proposed infrastructure can facilitate identification of EHR-related adverse events and errors and potentially create a safer and more effective EHR-based health care delivery system.
Diagnostic errors (missed, delayed, or wrong diagnosis) have gained recent attention and are associated with significant preventable morbidity and mortality. We reviewed the recent literature to identify interventions that have been, or could be, implemented to address systems-related factors that contribute directly to diagnostic error.
We conducted a comprehensive search using multiple search strategies. We first identified candidate articles in English between 2000 and 2009 from a PubMed search that exclusively evaluated for articles related to diagnostic error or delay. We then sought additional papers from references in the initial dataset, searches of additional databases, and subject matter experts. Articles were included if they formally evaluated an intervention to prevent or reduce diagnostic error; however, we also included papers if interventions were suggested and not tested in order to inform the state-of-the science on the topic. We categorized interventions according to the step in the diagnostic process they targeted: patient-provider encounter, performance and interpretation of diagnostic tests, follow-up and tracking of diagnostic information, subspecialty and referral-related; and patient-specific.
We identified 43 articles for full review, of which 6 reported tested interventions and 37 contained suggestions for possible interventions. Empirical studies, though somewhat positive, were non-experimental or quasi-experimental and included a small number of clinicians or health care sites. Outcome measures in general were underdeveloped and varied markedly between studies, depending on the setting or step in the diagnostic process involved.
Despite a number of suggested interventions in the literature, few empirical studies have tested interventions to reduce diagnostic error in the last decade. Advancing the science of diagnostic error prevention will require more robust study designs and rigorous definitions of diagnostic processes and outcomes to measure intervention effects.