Associations Between Organizational Communication and Patients' Experience of Prolonged Emotional Impact Following Medical Errors.

BACKGROUND: The emotional impact of medical errors on patients may be long-lasting. Factors associated with prolonged emotional impacts are poorly understood. METHODS: The authors conducted a subanalysis of a 2017 survey (response rate 36.8% [2,536/6,891]) of US adults to assess emotional impact of medical error. Patients reporting a medical error were included if the error occurred ≥ 1 year prior. Duration of emotional impact was categorized into no/short-term impact (impact lasting < 1 month), prolonged impact (> 1 month), and especially prolonged impact (> 1 year). Based on their reported experience with communication about the error, patients' experience was categorized as consistent with national disclosure guidelines, contrary to guidelines, mixed, or neither. Multinomial regression was used to examine associations between patient factors, event characteristics, and organizational communication with prolonged emotional impact (> 1 month, > 1 year). RESULTS: Of all survey respondents, 17.8% (451/2,536) reported an error occurring ≥ 1 year prior. Of these, 51.2% (231/451) reported prolonged/especially prolonged emotional impact (30.8% prolonged, 20.4% especially prolonged). Factors associated with prolonged emotional impact included female gender (adjusted odds ratio 2.1 [95% confidence interval 1.5-2.9]); low socioeconomic status (SES; 1.7 [1.1-2.7]); physical impact (7.3 [4.3-12.3]); no organizational disclosure and no patient/family error reporting (1.5 [1.03-2.3]); communication contrary to guidelines (4.0 [2.1-7.5]); and mixed communication (2.2 [1.3-3.7]). The same factors were significantly associated with especially prolonged emotional impact (female, 1.7 [1.2-2.5]; low SES, 2.2 [1.3-3.6]; physical impact, 6.8 [3.8-12.5]; no disclosure/reporting, 1.9 [1.2-3.2]; communication contrary to guidelines, 4.6 [2.2-9.4]; mixed communication, 2.1 [1.1-3.9]). CONCLUSION: Prolonged emotional impact affected more than half of Americans self-reporting a medical error. Organizational failure to communicate according to disclosure guidelines after patient-perceived errors may exacerbate harm, particularly for patients at risk of health care disparities.

Partnering with Patients and Families to Improve Diagnostic Safety through the OurDX Tool: Effects of Race, Ethnicity, and Language Preference.

BACKGROUND: Patients and families at risk for health disparities may also be at higher risk for diagnostic errors but less likely to report them. OBJECTIVES: This study aimed to explore differences in race, ethnicity, and language preference associated with patient and family contributions and concerns using an electronic previsit tool designed to engage patients and families in the diagnostic process (DxP). METHODS: Cross-sectional study of 5,731 patients and families presenting to three subspecialty clinics at an urban pediatric hospital May to December 2021 who completed a previsit tool, codeveloped and tested with patients and families. Prior to each visit, patients/families were invited to share visit priorities, recent histories, and potential diagnostic concerns. We used logistic regression to determine factors associated with patient-reported diagnostic concerns. We conducted chart review on a random subset of visits to review concerns and determine whether patient/family contributions were included in the visit note. RESULTS: Participants provided a similar mean number of contributions regardless of patient race, ethnicity, or language preference. Compared with patients self-identifying as White, those self-identifying as Black (odds ratio [OR]: 1.70; 95% confidence interval [CI]: [1.18, 2.43]) or "other" race (OR: 1.48; 95% CI: [1.08, 2.03]) were more likely to report a diagnostic concern. Participants who preferred a language other than English were more likely to report a diagnostic concern than English-preferring patients (OR: 2.53; 95% CI: [1.78, 3.59]. There were no significant differences in physician-verified diagnostic concerns or in integration of patient contributions into the note based on race, ethnicity, or language preference. CONCLUSION: Participants self-identifying as Black or "other" race, or those who prefer a language other than English were 1.5 to 2.5 times more likely than their counterparts to report potential diagnostic concerns when proactively asked to provide this information prior to a visit. Actively engaging patients and families in the DxP may uncover opportunities to reduce the risk of diagnostic errors and potential safety disparities.

Diagnostic error experiences of patients and families with limited English-language health literacy or disadvantaged socioeconomic position in a cross-sectional US population-based survey.

BACKGROUND: Language barrier, reduced self-advocacy, lower health literacy or biased care may hinder the diagnostic process. Data on how patients/families with limited English-language health literacy (LEHL) or disadvantaged socioeconomic position (dSEP) experience diagnostic errors are sparse. METHOD: We compared patient-reported diagnostic errors, contributing factors and impacts between respondents with LEHL or dSEP and their counterparts in the 2017 Institute for Healthcare Improvement US population-based survey, using contingency analysis and multivariable logistic regression models for the analyses. RESULTS: 596 respondents reported a diagnostic error; among these, 381 reported LEHL or dSEP. After adjusting for sex, race/ethnicity and physical health, individuals with LEHL/dSEP were more likely than their counterparts to report unique contributing factors: "(No) qualified translator or healthcare provider that spoke (the patient's) language" (OR and 95% CI 4.4 (1.3 to 14.9)); "not understanding the follow-up plan" (1.9 (1.1 to 3.1)); "too many providers… but no clear leader" (1.8 (1.2 to 2.7)); "not able to keep follow-up appointments" (1.9 (1.1 to 3.2)); "not being able to pay for necessary medical care" (2.5 (1.4 to 4.4)) and "out-of-date or incorrect medical records" (2.6 (1.4 to 4.8)). Participants with LEHL/dSEP were more likely to report long-term emotional, financial and relational impacts, compared with their counterparts. Subgroup analysis (LEHL-only and dSEP-only participants) showed similar results. CONCLUSIONS: Individuals with LEHL or dSEP identified unique and actionable contributing factors to diagnostic errors. Interpreter access should be viewed as a diagnostic safety imperative, social determinants affecting care access/affordability should be routinely addressed as part of the diagnostic process and patients/families should be encouraged to access and update their medical records. The frequent and disproportionate long-term impacts from self-reported diagnostic error among LEHL/dSEP patients/families raises urgency for greater prevention and supportive efforts.

The Reliability of Intraoperative Assessment on Predicting Tumor Size, Myometrial Invasion, and Cervical Involvement in Patients With a Preoperative Diagnosis of Complex Atypical Hyperplasia or (Clinical Stage I) Endometrial Cancer: A Prospective Cohort Study.

OBJECTIVES: The objective of this study is to assess the reliability of intraoperative uterine assessment compared with the final pathologic evaluation in patients with endometrial cancer (EC) and whether assessment improves with experience. METHODS: After Institutional Review Board approval, a prospective cohort study of women surgically managed with biopsy-proven complex atypical hyperplasia (CAH) or EC between March 2015 and December 2016 was performed. Demographics, preoperative biopsy results, procedure, intraoperative and final pathologic evaluation of lesion size, myometrial invasion, and lower uterine segment/cervical involvement were abstracted. The agreement between the intraoperative and final pathologic evaluation of tumor involvement of the uterus was determined using the kappa statistic and the intraclass correlation coefficient. RESULTS: A total of 264 patients with a preoperative diagnosis of CAH or EC were included-71 (26.9%) with CAH and 193 (73.1%) with EC. The mean age was 62.6±11.5, and mean body mass index was 37.2±10.1. The majority of women were white (67%). A total of 227 (85.9%) patients underwent a laparoscopic or robotic hysterectomy, whereas 36 (13.6%) underwent an abdominal hysterectomy. 233 (88.3%) patients had EC and 21 (7.9%) patients had CAH on final pathology. There was a fair agreement between the intraoperative estimation of myometrial invasion (κ=0.37). A moderate agreement exists between the intraoperative estimation of lower uterine segment/cervical involvement (κ=0.57). There was a strong agreement between intraoperative tumor size assessment and the final path (intraclass correlation coefficient=0.74). The intraoperative correlation of tumor size was similar for the first half of the cohort (κ=0.50) and the second half (κ=0.46) chronologically. CONCLUSIONS: Despite only a fair correlation in the myometrial invasion, intraoperative assessment of cervical involvement and especially tumor size is more readily identified and overall accurate. Therefore, intraoperative evaluation is an additional tool to use when making the decision to proceed with surgical staging.

Potential Changes to Louisiana Hardwood Timber Industry Economic Contributions Following Emerald Ash Borer (EAB) Invasion: An Input-Output Approach.

The emerald ash borer (EAB) Agrilus planipennis (Fairmaire, Coleoptera: Buprestidae) will have untold impacts on the contributions hardwood timber products provide Louisiana's economy. We modeled a scenario where ash mortality was assumed to follow a PERT-Beta distribution to kill essentially all Louisiana ash within 25 yr. Future ash mortality volumes were discounted to the present and valued using market prices to estimate a present effect on timber receipts. Assuming the dead timber would have otherwise been typical trees of average quality, stumpage was presently valued at US$1.57 million, with deliveries totaling US$3.48 million. A salvage arrangement using the double declining balance method coupled with a second PERT-Beta distribution centered upon Louisiana's current 2.84% harvest-to-inventory proportion depreciated the timber's value monthly over 1 yr. Following salvage, average stumpage revenue declined -US$1.54 million, mill deliveries fell -US$3.41 million, whereas state timber severance tax collections declined by -US$46,800. The value added and employment direct effects to Louisiana's economy averaged -US$882,400 and -41.6 jobs, respectively. The multiplier effects of these losses emanating from the timber industry resulted in additional declines averaging -US$2.56 million in value added and -45.6 jobs across the state economy on the drop in output of -US$4.51 million. The total economic effects summed to -US$3.44 million in value added and -87.1 jobs on output declines of -US$9.46 million.

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.

Can Communication-And-Resolution Programs Achieve Their Potential? Five Key Questions.

Communication-and-resolution programs (CRPs) are intended to promote accountability, transparency, and learning after adverse events. In this article we address five key challenges to the programs' future success: implementation fidelity, the evidence base for CRPs and their link to patient safety, fair compensation of harmed patients, alignment of CRP design with participants' needs, and public policy on CRPs. While the field has arrived at an understanding of the core communication-and-resolution practices, limited adherence fuels skepticism that programs are meeting the needs of patients and families who have been injured by care or improving patient safety. Adherence to communication-and-resolution practices could be enhanced by adopting measures of CRP quality and implementing programs in a comprehensive, principled, and systematic manner. Of particular importance is offering fair compensation to patients in CRPs and supporting their right to attorney representation. There is evidence that the use of CRPs reduces liability costs, but research on other outcomes is limited. Additional research is especially needed on the links between CRPs and quality and on the programs' alignment with patients' and families' needs. By honoring principles of transparency, quality improvement, and patient and family empowerment, organizations can use their CRPs to help revitalize the medical profession.

Resolving Malpractice Claims after Tort Reform: Experience in a Self-Insured Texas Public Academic Health System.

OBJECTIVE: To describe the litigation experience in a state with strict tort reform of a large public university health system that has committed to transparency with patients and families in resolving medical errors. DATA SOURCES/STUDY SETTING: Secondary data collected from The University of Texas System, which self-insures approximately 6,000 physicians at six health campuses across the state. We obtained internal case management data for all medical malpractice claims closed during 1 year before and 6 recent years following the enactment of state tort reform legislation. STUDY DESIGN: We retrospectively reviewed information about malpractice claimants, malpractice claims, and the process and outcome of dispute resolution. DATA COLLECTION/EXTRACTION METHODS: We accessed an internal case management database, supplemented by both electronic and paper records compiled by the university's Office of General Counsel. PRINCIPAL FINDINGS: Closed claims dropped from 244 in 2001-2002 to an annual mean of 96 in 2009-2015, closures following lawsuits from 136 in 2001-2002 to an annual mean of 28 in 2009-2015, and paid claims from 60 in 2001 to an annual mean of 20 in 2009-2015. Patterns of resolution suggest efforts by the university to provide some compensation to injured patients in cases that were no longer economically viable for plaintiffs' lawyers to litigate. The percentage of payments relating to cases in which lawsuits had been filed decreased from 82 percent in 2001-2002 to 47 percent in 2009-2012 and again to 29 percent in 2012-2015, although most paid claimants were represented by attorneys. Unrepresented patients received payment in 13 cases closed in 2009-2012 (22 percent of payments; mean amount $60,566) and in 24 cases closed in 2012-2015 (41 percent of payments; mean amount $109,410). Even after tort reform, however, claims that resulted in payment remained slow to resolve, which was worsened for claimants subject to Medicare secondary payer rules. Strict confidentiality became a more common condition of settlement, although restrictions were subsequently relaxed in order to further transparency and improve patient safety. CONCLUSIONS: Malpractice litigation risk diminished substantially for a public university health system in Texas following legal changes that reduced rights to sue and available damages. Health systems operating in a low-tort environment should work with policy makers, plaintiffs' attorneys, and patient groups to assist unrepresented patients, facilitate early mediation, limit nondisclosure obligations following settlement, and expedite the resolution of Medicare liens.

Distance from a Comprehensive Cancer Center: A proxy for poor cervical cancer outcomes?

OBJECTIVE: To evaluate the potential relationship between outcomes in cervical cancer patients based on distance from our Comprehensive Cancer Center (CCC). METHODS: A retrospective cohort study of cervical cancer patients was performed. Abstracted data included: demographics, clinicopathologic variables, treatment, and survival. Analyses both by quartiles and distance <100 and ≥100miles from our institution were performed. Data were analyzed using SAS version 9.2. RESULTS: 390 patients living a median distance of 58.1miles (range 1.2-571miles) from our CCC were identified. Patients were generally white (n=249), non-smokers (n=226), with Stage IB disease (n=222), squamous histology (n=295) and underwent primary surgical therapy (n=229). Patients were divided into both quartiles as well as two strata: <100 and ≥100miles for comparison. Progression-free survival (PFS) and overall survival (OS) favored patients living closer to our center with a lower median OS for patients living ≥100miles (65.4vs. 99.4months; p=0.040). Cox proportional hazard modeling noted that advanced stage was predictive of inferior PFS and OS, while other clinical covariates including age, BMI, race, smoking status and histology had a variable impact on outcomes and distance >100miles was associated with a higher risk of death (hazard ratio [HR]=1.68, 95% confidence interval [CI] 1.11-2.54). CONCLUSION: Overall survival for patients living >100miles from our CCC was worse when compared to patients in closer proximity. Outreach efforts and utilization of navigators may help decrease the impact of geographic and racial disparities on outcomes.

Structuring patient and family involvement in medical error event disclosure and analysis.

The study of adverse event disclosure has typically focused on the words that are said to the patient and family members after an event. But there is also growing interest in determining how patients and their families can be involved in the analysis of the adverse events that harmed them. We conducted a two-phase study to understand whether patients and families who have experienced an adverse event should be involved in the postevent analysis following the disclosure of a medical error. We first conducted twenty-eight interviews with patients, family members, clinicians, and administrators to determine the extent to which patients and family members are included in event analysis processes and to learn how their experiences might be improved. Then we reviewed our interview findings with patients and health care experts at a one-day national conference in October 2011. After evaluating the findings, conference participants concluded that increasing the involvement of patients and their families in the event analysis process was desirable but needed to be structured in a patient-centered way to be successful. We conclude by describing when and how information from patients might be incorporated into the event analysis process and by offering recommendations on how this might be accomplished.

Error disclosure: a new domain for safety culture assessment.

OBJECTIVE: To (1) develop and test survey items that measure error disclosure culture, (2) examine relationships among error disclosure culture, teamwork culture and safety culture and (3) establish predictive validity for survey items measuring error disclosure culture. METHOD: All clinical faculty from six health institutions (four medical schools, one cancer centre and one health science centre) in The University of Texas System were invited to anonymously complete an electronic survey containing questions about safety culture and error disclosure. RESULTS: The authors found two factors to measure error disclosure culture: one factor is focused on the general culture of error disclosure and the second factor is focused on trust. Both error disclosure culture factors were unique from safety culture and teamwork culture (correlations were less than r=0.85). Also, error disclosure general culture and error disclosure trust culture predicted intent to disclose a hypothetical error to a patient (r=0.25, p<0.001 and r=0.16, p<0.001, respectively) while teamwork and safety culture did not predict such an intent (r=0.09, p=NS and r=0.12, p=NS). Those who received prior error disclosure training reported significantly higher levels of error disclosure general culture (t=3.7, p<0.05) and error disclosure trust culture (t=2.9, p<0.05). CONCLUSIONS: The authors created and validated a new measure of error disclosure culture that predicts intent to disclose an error better than other measures of healthcare culture. This measure fills an existing gap in organisational assessments by assessing transparent communication after medical error, an important aspect of culture.

Impact of resident duty hour limits on safety in the intensive care unit: a national survey of pediatric and neonatal intensivists.

OBJECTIVE: Resident duty-hour regulations potentially shift the 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. DESIGN: Web-based survey. SETTING: U.S. academic pediatric and neonatal intensive care units. SUBJECTS: Attending pediatric and neonatal intensivists. INTERVENTIONS: We evaluated perceptions on four intensive care unit safety-related risk measures potentially affected by current duty-hour regulations: 1) attending physician and resident fatigue; 2) attending physician workload; 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 whom 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. CONCLUSIONS: 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 intensive care unit safety.

Costs and cost-effectiveness of a telemedicine intensive care unit program in 6 intensive care units in a large health care system.

PURPOSE: The purpose of this study is to estimate the costs and cost-effectiveness of a telemedicine intensive care unit (ICU) (tele-ICU) program. MATERIALS AND METHODS: We used an observational study with ICU patients cared for during the pre-tele-ICU period and ICU patients cared for during the post-tele-ICU period in 6 ICUs at 5 hospitals that are part of a large nonprofit health care system in the Gulf Coast region. We obtained data on a sample of 4142 ICU patients: 2034 in the pre-tele-ICU period and 2108 in the post-tele-ICU period. Economic outcomes were hospital costs, ICU costs and floor costs, measured for average daily costs, costs per case, and costs per patient. RESULTS: After the implementation of the tele-ICU, the hospital daily cost increased from $4302 to $5340 (24%); the hospital cost per case, from $21,967 to $31,318 (43%); and the cost per patient, from $20,231 to $25,846 (28%). Although the tele-ICU intervention was not cost-effective in patients with Simplified Acute Physiology Score II 50 or less, it was cost-effective in the sickest patients with Simplified Acute Physiology Score II more than 50 (17% of patients) because it decreased hospital mortality without increasing costs significantly. CONCLUSIONS: Hospital administrators may conclude that a tele-ICU program aimed at the sickest patients is cost-effective.

Navigating towards improved surgical safety using aviation-based strategies.

Safety practices in the aviation industry are being increasingly adapted to healthcare in an effort to reduce medical errors and patient harm. However, caution should be applied in embracing these practices because of limited experience in surgical disciplines, lack of rigorous research linking these practices to outcome, and fundamental differences between the two industries. Surgeons should have an in-depth understanding of the principles and data supporting aviation-based safety strategies before routinely adopting them. This paper serves as a review of strategies adapted to improve surgical safety, including the following: implementation of crew resource management in training operative teams; incorporation of simulation in training of technical and nontechnical skills; and analysis of contributory factors to errors using surveys, behavioral marker systems, human factors analysis, and incident reporting. Avenues and challenges for future research are also discussed.