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Liability Claims and Costs Before and After Implementation of a Medical Error Disclosure Program
480 , CHEST-COMPRESSION-ONLY VERSUS STANDARD CARDIOPULMONARY RESUSCITATION: A METAANALYSIS. Hupfl M, Selig H, Nagele P. Lancet 2010;376; 1552–7. This meta-analysis evaluated chest-compression-only cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest vs. standard bystander CPR (chest compression plus rescue ventilation). Several previous randomized trials and observational cohort studies have shown benefits of chest-compression-only CPR that were not statistically significant. Medline and Embase were systematically reviewed for studies published between January 1985 and August 2010, in which chestcompression-only CPR was compared to standard bystander CPR for out-of-hospital cardiac arrest. Ten studies were included in the meta-analysis. Three were randomized controlled trials and seven were observational cohorts. All three randomized controlled trials showed a small benefit in patients who received chest-compression-only CPR, but the differences were not significant (p values of 0.15, 0.31, and 0.17). Meta-analysis of these studies showed a significantly increased chance of survival with chest-compression-only CPR compared with standard CPR, with an absolute increase in survival of 2.4% (95% confidence interval [CI] 0.1–4.9). The number needed to treat was 41 (95% CI 20–1250). Seven observational cohort studies were also used for a secondary meta-analysis. All seven studies prospectively or retrospectively investigated the association between bystander CPR technique and survival. Apart from one study, none of the observational studies showed a significant survival difference between the two CPR techniques (8% vs. 8%, risk ratio 0.96, 95% CI 0.83–1.11). The authors concluded that for adults with out-of-hospital cardiac arrest, instructions to bystanders from Emergency Medical Services dispatch should focus on chest-compression-only CPR as opposed to standard CPR with chest compression plus rescue ventilation). [Erik Adler, MD Denver Health Medical Center, Denver, CO] Comment: Numerous prior studies have documented that uninterrupted, high-quality chest compression is optimal for successful CPR. Advocating for chest-compression-only CPR will likely increase the probably of bystander assistance, given the common reluctance to perform mouth-to-mouth resuscitation. Although flawed by its design, this study’s finding that the two methods are essentially equal should make this advocacy standard.
, FACTORS ASSOCIATED WITH NON-ADHERENCE TO EARLY GOAL-DIRECTED THERAPY IN THE ED. Mikkelsen ME, Gaieski DF, Goyal M, et al. Chest 2010;138; 551–8. Early goal-directed therapy (EGDT) has been shown to decrease mortality in emergency department patients with severe sepsis and septic shock. This single-center retrospective cohort study consisting of 340 patients from 2005–2007 sought to identify patient, provider, and organizational factors associated with non-adherence to EGDT. Inclusion criteria consisted of a serum lactate > 4 mmol/L or systolic blood pressure of < 90 mm Hg
Abstracts after volume resuscitation. Initiation of EGDT was defined as measurement of central venous oxygen saturation via central venous catheter. The authors concluded that EGDT was not initiated in 42% of eligible patients, and not completed in 43% of patients in which EGDT was initiated. They noted no decrease in mortality (both in-hospital and 28-day) with the initiation of EGTD. However, they did find increase in hospital mortality of 36% from 30% in those patients in which EGTD was initiated but not completed. Using multivariable logistic regression, they identified four risk factors expressed as odds ratios associated with EGDT non-compliance, including female gender of the patient (p = 0.01), female gender of the clinician (p = 0.041), serum lactate (rather than hemodynamic) criterion for EGDT (p = 0.018), and no consultation to the Severe Sepsis Service (p < 0.001). Of note, follow-up lactate levels were decreasing in 98% (60/61) of occult shock patients who did not receive EGDT. The authors conclude that although the generalizability of their study is limited and the decision to initiate EGDT is complex, identifying barriers of EGDT adherence is an important step in translating evidence into practice. [Nicole Seleno, MD Denver Health Medical Center, Denver, CO] Comment: EGDT has to date been the only ED intervention that positively impacts survival in septic patients. Although this study was small and limited to one institution, it highlights the importance of identifying the factors behind non-adherence to protocols in the management of the sickest patients. In this manner, change could be effected that could have an impact on survival. , LIABILITY CLAIMS AND COSTS BEFORE AND AFTER IMPLEMENTATION OF A MEDICAL ERROR DISCLOSURE PROGRAM. Kachalia A, Kaufman S, Boothman R, et al. Ann Intern Med 2010;153:213–21. This retrospective study from the University of Michigan Health System (UMHS) evaluated liability claims and costs before and after the implementation of the UMHS disclosure-withoffer program. In July of 2001, UMHS began responding to all open and new malpractice claims by admitting fault and offering compensation when an internal investigation revealed medical error. By February 2003, the disclosure program was fully integrated with patient safety efforts. Reporting employees, patients, family members, or patients’ attorneys identified patient injuries. Experienced risk managers with clinical backgrounds led investigations and determined the appropriate conclusions and settlements. Claims included those reported to risk management from July 1, 1995 to September 30, 2007, with July 1, 2001 as the date of initial implementation of the disclosure program and February 1, 2003 as the date of full implementation. The four primary study measures included the number of new claims, number of claims receiving compensation, time to claim resolution, and claims-related costs. Of the 1121 total claims contained in the UMHS risk management claims database during the study period, 633 were asserted before and 498 after implementation of the disclosure-with-offer program. The monthly rate of new claims decreased from 7.03 (95% confidence interval [CI] 5.98–8.08) per 100,000 patient encounters before initial
The Journal of Emergency Medicine program implementation to 4.52 (95% CI 3.96–5.08) after implementation (relative risk [RR] 0.64; 95% CI 0.44–0.95). The trend in monthly claims rate decreased after the program was initially implemented with a before-after difference of 0.059 (95% CI 0.110 to 0.008); p = 0.023. The average monthly rate of lawsuits decreased from 2.13 to 0.75 per 100,000 patient encounters (RR 0.35; 95% CI 0.22–0.58). Median time to claim resolution was 1.36 years (interquartile range [IQR] 0.72–2.44 years) before initial implementation and 0.95 year (IQR 0.55– 1.96 years) after initial program implementation. The rate of resolution increased after program implementation with an adjusted hazard ratio of 1.27 (95% CI 1.11–1.45; p < 0.001). Median and mean total liability costs decreased after full program implementation (RR for mean costs, 0.41; 95% CI 0.26–0.66; p < 0.001). The average cost per lawsuit significantly decreased from $405,921 before to $228,308 after initial program implementation (RR 0.40; 95% CI 0.24–0.68; p < 0.001). The authors concluded that all four primary end points were met and that it is possible to implement a disclosure-with-offer program without increasing liability to claims and costs. [Zahir Basrai, MD Denver Health Medical Center, Denver, CO] Comment: This study continues to build evidence of the importance of transparency and communication with patients in minimizing liability claims and costs. Although the net costs involved with claims decreased with a statistical significance, the study does not provide an actuarial perspective of the projected financial savings from the decrease in litigation costs vs. the costs of implementing the disclosure program. Nonetheless, this program seems to combine the best elements of doing the right thing and containing costs. , ACUTE ACHILLES TENDON RUPTURE: A RANDOMIZED, CONTROLLED STUDY COMPARING SURGICAL AND NONSURGICAL TREATMENTS USING VALIDATED OUTCOME MEASURES. Nilsson-Helander K, Gravare K, Thomee R, et al. Am J Sports Med 2010;38; 2186–93. Acute Achilles tendon rupture is a common complaint encountered by many emergency physicians. There is considerable debate as to optimal treatment. Previous studies favor a surgical over a non-surgical approach due to higher re-rupture rates seen in patients treated non-surgically. Meta-analyses generally agree that the re-rupture rate is much higher in patients treated non-surgically (12.6%) than in patients treated surgically (3.5%). Few studies, however, standardize mobilization technique and physical therapy protocol for both groups. Typically, surgically treated patients were mobilized much sooner than non-operative patients, with the rationale being that the non-surgical patient requires a longer time period of immobilization to allow the free ends of the Achilles tendon to attach. This randomized controlled trial attempted to compare outcomes of patients with acute Achilles tendon rupture treated with or without surgery using early mobilization and identical rehabilitation protocols. One hundred patients with acute Achilles tendon rupture seen at the Emergency Department at the Sahlgrenska University Hospital in Gothenburg, Sweden from
481 2004 to 2007 were included in this study. Exclusion criteria were diabetes mellitus, previous Achilles tendon rupture, other lower leg injuries, immunosuppressive therapy, and neurovascular disease. Patients between 16 and 65 years of age with a unilateral Achilles tendon rupture were randomized to either a surgical or non-surgical treatment group. Surgery technique was standardized for all 49 surgical patients. The non-surgical group included 48 patients. Both groups were treated with a below-the-knee cast with the foot in equinus position for 2 weeks, followed by an adjustable brace for the next 6 weeks, with progressive decrease in plantar flexion as time progressed. The primary end point was re-rupturing, but patients were also evaluated using the Achilles tendon Total Rupture Score, functional tests, and clinical examination at 6 and 12 months after injury. The results demonstrated six (12%) re-ruptures in the non-surgical group and two (4%) in the surgical group (p value of 0.377). At the 6-month evaluation, the surgical group had better results compared with the non-surgically treated group in some of the muscle function tests; however, at the 12-month evaluation there were no differences between the two groups except for one of the many exercises (heel-rise work test, which favored the surgical group). The authors concluded that there was no statistically significant difference between surgical and non-surgical treatment for acute Achilles tendon rupture. However, early mobilization is beneficial. [Erik Adler, MD Denver Health Medical Center, Denver, CO] Comment: Although not statistically significant, the difference in the rate of re-rupture certainly seems clinically significant. It is possible that with a larger study this difference would have become statistically significant, representing a type II error. In addition, the finding that early mobilization is important, although a benign intervention, should also be evaluated in a larger study. , PREVALENCE OF MAJOR COMORBIDITIES IN SUBJECTS WITH COPD AND INCIDENCE OF MYOCARDIAL INFARCTION AND STROKE: A COMPREHENSIVE ANALYSIS USING DATA FROM PRIMARY CARE. Feary JR, Rodrigues LC, Smith CJ, et al. Thorax 2010 65:956–62. It is well known that in addition to airflow limitation and inflammation, chronic obstructive pulmonary disease (COPD) is associated with significant extrapulmonary effects. This case control study from the United Kingdom evaluated 1,204,100 members (35 years old or older) of the general UK population on February 25, 2005 using a computerized database from primary care records of 311 general practices throughout the United Kingdom. The authors sought to quantify the number of COPD patients (defined as ‘‘recorded diagnosis’’ in medical chart) and evaluate for additional comorbidities, specifically, diabetes mellitus (DM), cardiovascular disease (CVD) (which was defined as angina, myocardial infarction [MI], heart failure, peripheral vascular disease, aortic aneurysm, and previous angioplasty procedure), and cerebrovascular disease present in COPD patients. Multivariate logistic regression was used to analyze data, and results were expressed in both odds ratios (OR)
, FACTORS ASSOCIATED WITH NON-ADHERENCE TO EARLY GOAL-DIRECTED THERAPY IN THE ED. Mikkelsen ME, Gaieski DF, Goyal M, et al. Chest 2010;138; 551–8. Early goal-directed therapy (EGDT) has been shown to decrease mortality in emergency department patients with severe sepsis and septic shock. This single-center retrospective cohort study consisting of 340 patients from 2005–2007 sought to identify patient, provider, and organizational factors associated with non-adherence to EGDT. Inclusion criteria consisted of a serum lactate > 4 mmol/L or systolic blood pressure of < 90 mm Hg
Abstracts after volume resuscitation. Initiation of EGDT was defined as measurement of central venous oxygen saturation via central venous catheter. The authors concluded that EGDT was not initiated in 42% of eligible patients, and not completed in 43% of patients in which EGDT was initiated. They noted no decrease in mortality (both in-hospital and 28-day) with the initiation of EGTD. However, they did find increase in hospital mortality of 36% from 30% in those patients in which EGTD was initiated but not completed. Using multivariable logistic regression, they identified four risk factors expressed as odds ratios associated with EGDT non-compliance, including female gender of the patient (p = 0.01), female gender of the clinician (p = 0.041), serum lactate (rather than hemodynamic) criterion for EGDT (p = 0.018), and no consultation to the Severe Sepsis Service (p < 0.001). Of note, follow-up lactate levels were decreasing in 98% (60/61) of occult shock patients who did not receive EGDT. The authors conclude that although the generalizability of their study is limited and the decision to initiate EGDT is complex, identifying barriers of EGDT adherence is an important step in translating evidence into practice. [Nicole Seleno, MD Denver Health Medical Center, Denver, CO] Comment: EGDT has to date been the only ED intervention that positively impacts survival in septic patients. Although this study was small and limited to one institution, it highlights the importance of identifying the factors behind non-adherence to protocols in the management of the sickest patients. In this manner, change could be effected that could have an impact on survival. , LIABILITY CLAIMS AND COSTS BEFORE AND AFTER IMPLEMENTATION OF A MEDICAL ERROR DISCLOSURE PROGRAM. Kachalia A, Kaufman S, Boothman R, et al. Ann Intern Med 2010;153:213–21. This retrospective study from the University of Michigan Health System (UMHS) evaluated liability claims and costs before and after the implementation of the UMHS disclosure-withoffer program. In July of 2001, UMHS began responding to all open and new malpractice claims by admitting fault and offering compensation when an internal investigation revealed medical error. By February 2003, the disclosure program was fully integrated with patient safety efforts. Reporting employees, patients, family members, or patients’ attorneys identified patient injuries. Experienced risk managers with clinical backgrounds led investigations and determined the appropriate conclusions and settlements. Claims included those reported to risk management from July 1, 1995 to September 30, 2007, with July 1, 2001 as the date of initial implementation of the disclosure program and February 1, 2003 as the date of full implementation. The four primary study measures included the number of new claims, number of claims receiving compensation, time to claim resolution, and claims-related costs. Of the 1121 total claims contained in the UMHS risk management claims database during the study period, 633 were asserted before and 498 after implementation of the disclosure-with-offer program. The monthly rate of new claims decreased from 7.03 (95% confidence interval [CI] 5.98–8.08) per 100,000 patient encounters before initial
The Journal of Emergency Medicine program implementation to 4.52 (95% CI 3.96–5.08) after implementation (relative risk [RR] 0.64; 95% CI 0.44–0.95). The trend in monthly claims rate decreased after the program was initially implemented with a before-after difference of 0.059 (95% CI 0.110 to 0.008); p = 0.023. The average monthly rate of lawsuits decreased from 2.13 to 0.75 per 100,000 patient encounters (RR 0.35; 95% CI 0.22–0.58). Median time to claim resolution was 1.36 years (interquartile range [IQR] 0.72–2.44 years) before initial implementation and 0.95 year (IQR 0.55– 1.96 years) after initial program implementation. The rate of resolution increased after program implementation with an adjusted hazard ratio of 1.27 (95% CI 1.11–1.45; p < 0.001). Median and mean total liability costs decreased after full program implementation (RR for mean costs, 0.41; 95% CI 0.26–0.66; p < 0.001). The average cost per lawsuit significantly decreased from $405,921 before to $228,308 after initial program implementation (RR 0.40; 95% CI 0.24–0.68; p < 0.001). The authors concluded that all four primary end points were met and that it is possible to implement a disclosure-with-offer program without increasing liability to claims and costs. [Zahir Basrai, MD Denver Health Medical Center, Denver, CO] Comment: This study continues to build evidence of the importance of transparency and communication with patients in minimizing liability claims and costs. Although the net costs involved with claims decreased with a statistical significance, the study does not provide an actuarial perspective of the projected financial savings from the decrease in litigation costs vs. the costs of implementing the disclosure program. Nonetheless, this program seems to combine the best elements of doing the right thing and containing costs. , ACUTE ACHILLES TENDON RUPTURE: A RANDOMIZED, CONTROLLED STUDY COMPARING SURGICAL AND NONSURGICAL TREATMENTS USING VALIDATED OUTCOME MEASURES. Nilsson-Helander K, Gravare K, Thomee R, et al. Am J Sports Med 2010;38; 2186–93. Acute Achilles tendon rupture is a common complaint encountered by many emergency physicians. There is considerable debate as to optimal treatment. Previous studies favor a surgical over a non-surgical approach due to higher re-rupture rates seen in patients treated non-surgically. Meta-analyses generally agree that the re-rupture rate is much higher in patients treated non-surgically (12.6%) than in patients treated surgically (3.5%). Few studies, however, standardize mobilization technique and physical therapy protocol for both groups. Typically, surgically treated patients were mobilized much sooner than non-operative patients, with the rationale being that the non-surgical patient requires a longer time period of immobilization to allow the free ends of the Achilles tendon to attach. This randomized controlled trial attempted to compare outcomes of patients with acute Achilles tendon rupture treated with or without surgery using early mobilization and identical rehabilitation protocols. One hundred patients with acute Achilles tendon rupture seen at the Emergency Department at the Sahlgrenska University Hospital in Gothenburg, Sweden from
481 2004 to 2007 were included in this study. Exclusion criteria were diabetes mellitus, previous Achilles tendon rupture, other lower leg injuries, immunosuppressive therapy, and neurovascular disease. Patients between 16 and 65 years of age with a unilateral Achilles tendon rupture were randomized to either a surgical or non-surgical treatment group. Surgery technique was standardized for all 49 surgical patients. The non-surgical group included 48 patients. Both groups were treated with a below-the-knee cast with the foot in equinus position for 2 weeks, followed by an adjustable brace for the next 6 weeks, with progressive decrease in plantar flexion as time progressed. The primary end point was re-rupturing, but patients were also evaluated using the Achilles tendon Total Rupture Score, functional tests, and clinical examination at 6 and 12 months after injury. The results demonstrated six (12%) re-ruptures in the non-surgical group and two (4%) in the surgical group (p value of 0.377). At the 6-month evaluation, the surgical group had better results compared with the non-surgically treated group in some of the muscle function tests; however, at the 12-month evaluation there were no differences between the two groups except for one of the many exercises (heel-rise work test, which favored the surgical group). The authors concluded that there was no statistically significant difference between surgical and non-surgical treatment for acute Achilles tendon rupture. However, early mobilization is beneficial. [Erik Adler, MD Denver Health Medical Center, Denver, CO] Comment: Although not statistically significant, the difference in the rate of re-rupture certainly seems clinically significant. It is possible that with a larger study this difference would have become statistically significant, representing a type II error. In addition, the finding that early mobilization is important, although a benign intervention, should also be evaluated in a larger study. , PREVALENCE OF MAJOR COMORBIDITIES IN SUBJECTS WITH COPD AND INCIDENCE OF MYOCARDIAL INFARCTION AND STROKE: A COMPREHENSIVE ANALYSIS USING DATA FROM PRIMARY CARE. Feary JR, Rodrigues LC, Smith CJ, et al. Thorax 2010 65:956–62. It is well known that in addition to airflow limitation and inflammation, chronic obstructive pulmonary disease (COPD) is associated with significant extrapulmonary effects. This case control study from the United Kingdom evaluated 1,204,100 members (35 years old or older) of the general UK population on February 25, 2005 using a computerized database from primary care records of 311 general practices throughout the United Kingdom. The authors sought to quantify the number of COPD patients (defined as ‘‘recorded diagnosis’’ in medical chart) and evaluate for additional comorbidities, specifically, diabetes mellitus (DM), cardiovascular disease (CVD) (which was defined as angina, myocardial infarction [MI], heart failure, peripheral vascular disease, aortic aneurysm, and previous angioplasty procedure), and cerebrovascular disease present in COPD patients. Multivariate logistic regression was used to analyze data, and results were expressed in both odds ratios (OR)