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Delays in Diagnosis and Treatment
Clostridium difficileassociated disease (CDAD) is a well‐known complication of hospitalization and is the most frequently identified cause of nosocomial diarrhea that hospitalists encounter. Despite widespread epidemiologic attempts to control the disease, its prevalence and clinical severity appear to be increasing.1 The resulting social and economic consequences are profound. The estimated 3 million inpatient cases of CDAD a year result in an average increase in the length of stay of 3.6 days at a cost in inpatient health care of more than $1 billion.2
Early diagnosis of index cases is crucial. A diagnostic delay can result in a treatment delay for the index case, as well as in a delay in implementing isolation procedures to prevent horizontal transmission. Acquisition of CDAD is time dependent and occurs in 20% to 30% of hospitalized patients at a rate of approximately 8% per week.3, 4 This transmission is primarily a result of environmental contamination with CDAD spores, found on 59% of the hands of hospital personnel caring for infected patients, in 49% of rooms of symptomatic patients, and in 29% of rooms of asymptomatic carriers.5 Despite the need for early diagnosis, a study from the United Kingdom documented that the average time from the onset of diarrhea to sampling of CDAD patients is 4.7 days.6 An additional challenge for early diagnosis is the delay in microbiological confirmation of CDAD in a suspected patient. Cytotoxic assays, which have become the standard diagnostic technique for CDAD, exhibit excellent sensitivity and specificity but have a lengthy processing time, between 2 and 4 days. Although antigen detection assays can be rapidly performed, many have inadequate sensitivity and specificity.7
These issues of diagnostic and treatment delays are compounded in patients with recurrent CDAD. As many as 15%35% of patients with an initial CDAD infection will experience a recurrence, usually within 2 months. At least half these infections are a result of reinfection, not relapse.8 This implies that early detection and strict isolation of infected patients is essential for reducing the exposure of at‐risk patients to the disease. There is evidence that the burden of patients on the same ward simultaneously having CDAD increases a patient's risk of acquiring the disease.9 It is currently unknown if recurrent CDAD cases are diagnosed or treated earlier than initial cases. If not, this is a potentially important patient population for hospitalists to target for aggressive containment strategies. This study sought to determine the mean time to sampling and treatment in patients with recurrent CDAD infection compared with those in patients who are initially infected.
Design
The study cohort consisted of all adult patients more than 18 years old with CDAD (by ICD9 code) who had been hospitalized at Brigham and Women's Hospital between 1997 and 2004. Retrospectively, patients were identified through the Partners Healthcare Research Patient Data Repository (RPDR). The RPDR is a centralized clinical data registry that gathers data from various hospital legacy systems and was used to determine the patient demographics and first date of treatment (with vancomycin or metronidazole). Medical and microbiologic records were reviewed to determine the dates of cytotoxic assay submission and symptom onset. Symptoms were defined as diarrhea, abdominal pain/cramping, or radiological/colonoscopic evidence of colitis. Recurrence was defined as any repeat inpatient CDAD diagnosis within 2 months (regardless of admission diagnosis). Baseline characteristics in the recurrence and no‐recurrence populations were compared by the 2‐sided Student t test or the chi‐square test (for continuous and categorical variables, respectively). Mean time from symptom to sampling, from symptom to treatment, and from sampling to treatment were compared between initial and recurrent disease episodes by the 2‐sided Student t test. All P values < .05 were considered significant. Institutional review board approval was obtained by Partners Healthcare.
RESULTS
Between 1997 and 2004 there were 1309 patients with an ICD9 code for CDAD, 151 of whom (12%) had a recurrence. Of these, 125 had 1 recurrence, 23 had 2 recurrences, and 3 had 3 recurrences. There were no significant differences between the groups in basic demographics (Table 1). The mean time to sampling was not significantly different between initial and recurrent CDAD hospital episodes (Table 2). However, the mean time to treatment (from symptoms and sampling) was shorter in recurrent episodes (Table 2). From 1997 to 2004 there was no significant reduction in time to sampling, but there was a significant reduction in time to treatment, from 3.89 days (19972000) to 2.30 days (2001 2004), P = .0012.
| Characteristic | Patients without recurrent disease (n = 1158) | Patients with recurrent disease (n = 151) | P value |
|---|---|---|---|
| Sex (% male) | 45% | 45% | .98 |
| Age (mean) | 68.3 years | 69.9 years | .72 |
| Race (% white) | 80% | 80% | .97 |
| Language (English) | 94% | 92% | .83 |
| First episode (n = 1309) | Recurrence (n = 180)* | P value | |
|---|---|---|---|
| |||
| Symptoms to sampling | 2.24 days (117 days) | 2.09 days (116 days) | 0.700 |
| Symptoms to treatment | 3.64 days (118 days) | 2.52 days (119 days) | 0.024 |
| Sampling to treatment | 3.76 days (119 days) | 2.57 days (119 days) | 0.006 |
DISCUSSION
Clostridium difficileassociated disease (CDAD) has become a significant nosocomial infection in medical institutions, and recurrent CDAD is emerging as a disease of concern for hospitalists. Diagnostic delays represent a major epidemiologic problem, resulting in both delay of treatment delay of the index case and delay in implementing isolation procedures to prevent horizontal transmission. In this study, patients with recurrent disease did not have stool collected any earlier than did patients with their initial episode of CDAD, and these diagnostic delays did not change in successive eras. Recurrent disease patients did receive treatment earlier than did patients with initial episodes. Although this empiric treatment strategy is encouraging and likely reflects heightened awareness of the disease over time, the 2.5‐day span from symptoms to treatment is still a clinically significant delay. Also of concern is the range of time from symptoms to treatment, as long as 19 days in the recurrent treatment group. Although most patients were treated within 12 days, this variability represents the burden of infectious patients with the potential for infecting others. Targeting recurrent CDAD populations for early diagnosis, treatment, and isolation would almost certainly reduce the morbidity associated with horizontal transmission rates.9
This study had several limitations. Our data found a lower incidence of recurrent CDAD than previously published in the literature. This can be accounted for by the identification of cases by ICD9 code, which previously has been documented to underestimate true disease.10, 11 We also were not able to capture recurrent episodes in outpatients or episodes that occurred after the 2004 cohort, which underestimated the true frequency of recurrence. At worst, this underestimation could bias the results toward the null hypothesis. An additional limitation of the study was the assumption that time to treatment was accurately reflected by time to prescription of either vancomycin or flagyl. Some patients may have been treated by suspending treatment with the offending antibiotic along with watchful waiting, which is a reasonable strategy for patients with mild disease and is endorsed by the American College of Gastroenterology and the Society for Healthcare Epidemiology of America.12, 13 This would overestimate time to treatment for those individuals and would make time to treatment appear longer, but would not affect time to sampling. In addition, the symptoms collected from chart review were assumed to be a result of the patient's CDAD, but there is a chance that these symptoms such as diarrhea, abdominal pain, and cramping may have been a result of a different diagnosis. These data were also limited to a cohort from a single institution and may not reflect the patient characteristics or practice patterns at other institutions.
In conclusion, CDAD is a major contributor to morbidity from nosocomial infections, and recurrent CDAD patients are a likely source of horizontal disease transmission. This study documented that there are significant diagnostic and treatment delays, even in populations with recurrent disease. It is especially important that hospitalists take measures to improve the early diagnosis, treatment, and isolation of these patients in order to improve these deficiencies in care.
- ,,,.Ten years of prospective Clostridium difficile‐associated disease surveillance and treatment at the Minneapolis VA Medical Center, 1982–1991.Infect Control Hosp Epidemiol.1994;15:371–381.
- ,,,.Health care costs and mortality associated with nosocomial diarrhea due to clostridium difficile.Clin Infect Dis.2002;34:346–353.
- ,,, et al.Nosocomial Clostridium difficile colonization and disease.Lancet.1990;336:97–100.
- ,,,.Asymptomatic carriage of Clostridium difficile and serum levels of IgG antibody against Toxin A.N Engl J Med.2000;342:390–397.
- ,,,.Nosocomial acquisition of Clostridium difficile infection.N Engl J Med.1989;320:204–210.
- ,.Reducing delays in the diagnosis and treatment of Clostridium difficile diarrhoea.QJM.2003;96:579–582.
- ,,, et al.Multicenter evaluation of four methods for Clostridium difficile detection: ImmunoCard C. difficile, cytotoxin assay, culture, and latex agglutination.J Clin Microbiol.1996;34:2718–2721.
- ,,, et al.Epidemiology of recurrences or reinfections of Clostridium difficile–associated diarrhea.J Clin Microbiol.2000;38:2386–2388.
- ,,, et al.Evaluation of Clostridium difficile‐associated disease pressure as a risk factor for C difficile–associated disease.Arch Intern Med.2007;167:1092–1097.
- ,,,.Accuracy of ICD9 coding for Clostridium difficile infections.Epidemiol Infect.2006;135:1010–1013.
- Emerging Infectious Diseases online publication Available at: http://www.cdc.gov/ncidod/EID/vol12no10/06‐0016.htm. Accessed July 12,2007.
- .Guidelines for the diagnosis and management of Clostridium difficile–associated diarrhea and colitis.American College of Gastroenterology, Practice Parameters Committee.Am J Gastroenterol.1997;92:739–750.
- ,,,,.SHEA position paper. Clostridium difficile associated diarrhea and colitis.Infect Control Hosp Epidemiol.1995;16:459–477.
Clostridium difficileassociated disease (CDAD) is a well‐known complication of hospitalization and is the most frequently identified cause of nosocomial diarrhea that hospitalists encounter. Despite widespread epidemiologic attempts to control the disease, its prevalence and clinical severity appear to be increasing.1 The resulting social and economic consequences are profound. The estimated 3 million inpatient cases of CDAD a year result in an average increase in the length of stay of 3.6 days at a cost in inpatient health care of more than $1 billion.2
Early diagnosis of index cases is crucial. A diagnostic delay can result in a treatment delay for the index case, as well as in a delay in implementing isolation procedures to prevent horizontal transmission. Acquisition of CDAD is time dependent and occurs in 20% to 30% of hospitalized patients at a rate of approximately 8% per week.3, 4 This transmission is primarily a result of environmental contamination with CDAD spores, found on 59% of the hands of hospital personnel caring for infected patients, in 49% of rooms of symptomatic patients, and in 29% of rooms of asymptomatic carriers.5 Despite the need for early diagnosis, a study from the United Kingdom documented that the average time from the onset of diarrhea to sampling of CDAD patients is 4.7 days.6 An additional challenge for early diagnosis is the delay in microbiological confirmation of CDAD in a suspected patient. Cytotoxic assays, which have become the standard diagnostic technique for CDAD, exhibit excellent sensitivity and specificity but have a lengthy processing time, between 2 and 4 days. Although antigen detection assays can be rapidly performed, many have inadequate sensitivity and specificity.7
These issues of diagnostic and treatment delays are compounded in patients with recurrent CDAD. As many as 15%35% of patients with an initial CDAD infection will experience a recurrence, usually within 2 months. At least half these infections are a result of reinfection, not relapse.8 This implies that early detection and strict isolation of infected patients is essential for reducing the exposure of at‐risk patients to the disease. There is evidence that the burden of patients on the same ward simultaneously having CDAD increases a patient's risk of acquiring the disease.9 It is currently unknown if recurrent CDAD cases are diagnosed or treated earlier than initial cases. If not, this is a potentially important patient population for hospitalists to target for aggressive containment strategies. This study sought to determine the mean time to sampling and treatment in patients with recurrent CDAD infection compared with those in patients who are initially infected.
Design
The study cohort consisted of all adult patients more than 18 years old with CDAD (by ICD9 code) who had been hospitalized at Brigham and Women's Hospital between 1997 and 2004. Retrospectively, patients were identified through the Partners Healthcare Research Patient Data Repository (RPDR). The RPDR is a centralized clinical data registry that gathers data from various hospital legacy systems and was used to determine the patient demographics and first date of treatment (with vancomycin or metronidazole). Medical and microbiologic records were reviewed to determine the dates of cytotoxic assay submission and symptom onset. Symptoms were defined as diarrhea, abdominal pain/cramping, or radiological/colonoscopic evidence of colitis. Recurrence was defined as any repeat inpatient CDAD diagnosis within 2 months (regardless of admission diagnosis). Baseline characteristics in the recurrence and no‐recurrence populations were compared by the 2‐sided Student t test or the chi‐square test (for continuous and categorical variables, respectively). Mean time from symptom to sampling, from symptom to treatment, and from sampling to treatment were compared between initial and recurrent disease episodes by the 2‐sided Student t test. All P values < .05 were considered significant. Institutional review board approval was obtained by Partners Healthcare.
RESULTS
Between 1997 and 2004 there were 1309 patients with an ICD9 code for CDAD, 151 of whom (12%) had a recurrence. Of these, 125 had 1 recurrence, 23 had 2 recurrences, and 3 had 3 recurrences. There were no significant differences between the groups in basic demographics (Table 1). The mean time to sampling was not significantly different between initial and recurrent CDAD hospital episodes (Table 2). However, the mean time to treatment (from symptoms and sampling) was shorter in recurrent episodes (Table 2). From 1997 to 2004 there was no significant reduction in time to sampling, but there was a significant reduction in time to treatment, from 3.89 days (19972000) to 2.30 days (2001 2004), P = .0012.
| Characteristic | Patients without recurrent disease (n = 1158) | Patients with recurrent disease (n = 151) | P value |
|---|---|---|---|
| Sex (% male) | 45% | 45% | .98 |
| Age (mean) | 68.3 years | 69.9 years | .72 |
| Race (% white) | 80% | 80% | .97 |
| Language (English) | 94% | 92% | .83 |
| First episode (n = 1309) | Recurrence (n = 180)* | P value | |
|---|---|---|---|
| |||
| Symptoms to sampling | 2.24 days (117 days) | 2.09 days (116 days) | 0.700 |
| Symptoms to treatment | 3.64 days (118 days) | 2.52 days (119 days) | 0.024 |
| Sampling to treatment | 3.76 days (119 days) | 2.57 days (119 days) | 0.006 |
DISCUSSION
Clostridium difficileassociated disease (CDAD) has become a significant nosocomial infection in medical institutions, and recurrent CDAD is emerging as a disease of concern for hospitalists. Diagnostic delays represent a major epidemiologic problem, resulting in both delay of treatment delay of the index case and delay in implementing isolation procedures to prevent horizontal transmission. In this study, patients with recurrent disease did not have stool collected any earlier than did patients with their initial episode of CDAD, and these diagnostic delays did not change in successive eras. Recurrent disease patients did receive treatment earlier than did patients with initial episodes. Although this empiric treatment strategy is encouraging and likely reflects heightened awareness of the disease over time, the 2.5‐day span from symptoms to treatment is still a clinically significant delay. Also of concern is the range of time from symptoms to treatment, as long as 19 days in the recurrent treatment group. Although most patients were treated within 12 days, this variability represents the burden of infectious patients with the potential for infecting others. Targeting recurrent CDAD populations for early diagnosis, treatment, and isolation would almost certainly reduce the morbidity associated with horizontal transmission rates.9
This study had several limitations. Our data found a lower incidence of recurrent CDAD than previously published in the literature. This can be accounted for by the identification of cases by ICD9 code, which previously has been documented to underestimate true disease.10, 11 We also were not able to capture recurrent episodes in outpatients or episodes that occurred after the 2004 cohort, which underestimated the true frequency of recurrence. At worst, this underestimation could bias the results toward the null hypothesis. An additional limitation of the study was the assumption that time to treatment was accurately reflected by time to prescription of either vancomycin or flagyl. Some patients may have been treated by suspending treatment with the offending antibiotic along with watchful waiting, which is a reasonable strategy for patients with mild disease and is endorsed by the American College of Gastroenterology and the Society for Healthcare Epidemiology of America.12, 13 This would overestimate time to treatment for those individuals and would make time to treatment appear longer, but would not affect time to sampling. In addition, the symptoms collected from chart review were assumed to be a result of the patient's CDAD, but there is a chance that these symptoms such as diarrhea, abdominal pain, and cramping may have been a result of a different diagnosis. These data were also limited to a cohort from a single institution and may not reflect the patient characteristics or practice patterns at other institutions.
In conclusion, CDAD is a major contributor to morbidity from nosocomial infections, and recurrent CDAD patients are a likely source of horizontal disease transmission. This study documented that there are significant diagnostic and treatment delays, even in populations with recurrent disease. It is especially important that hospitalists take measures to improve the early diagnosis, treatment, and isolation of these patients in order to improve these deficiencies in care.
Clostridium difficileassociated disease (CDAD) is a well‐known complication of hospitalization and is the most frequently identified cause of nosocomial diarrhea that hospitalists encounter. Despite widespread epidemiologic attempts to control the disease, its prevalence and clinical severity appear to be increasing.1 The resulting social and economic consequences are profound. The estimated 3 million inpatient cases of CDAD a year result in an average increase in the length of stay of 3.6 days at a cost in inpatient health care of more than $1 billion.2
Early diagnosis of index cases is crucial. A diagnostic delay can result in a treatment delay for the index case, as well as in a delay in implementing isolation procedures to prevent horizontal transmission. Acquisition of CDAD is time dependent and occurs in 20% to 30% of hospitalized patients at a rate of approximately 8% per week.3, 4 This transmission is primarily a result of environmental contamination with CDAD spores, found on 59% of the hands of hospital personnel caring for infected patients, in 49% of rooms of symptomatic patients, and in 29% of rooms of asymptomatic carriers.5 Despite the need for early diagnosis, a study from the United Kingdom documented that the average time from the onset of diarrhea to sampling of CDAD patients is 4.7 days.6 An additional challenge for early diagnosis is the delay in microbiological confirmation of CDAD in a suspected patient. Cytotoxic assays, which have become the standard diagnostic technique for CDAD, exhibit excellent sensitivity and specificity but have a lengthy processing time, between 2 and 4 days. Although antigen detection assays can be rapidly performed, many have inadequate sensitivity and specificity.7
These issues of diagnostic and treatment delays are compounded in patients with recurrent CDAD. As many as 15%35% of patients with an initial CDAD infection will experience a recurrence, usually within 2 months. At least half these infections are a result of reinfection, not relapse.8 This implies that early detection and strict isolation of infected patients is essential for reducing the exposure of at‐risk patients to the disease. There is evidence that the burden of patients on the same ward simultaneously having CDAD increases a patient's risk of acquiring the disease.9 It is currently unknown if recurrent CDAD cases are diagnosed or treated earlier than initial cases. If not, this is a potentially important patient population for hospitalists to target for aggressive containment strategies. This study sought to determine the mean time to sampling and treatment in patients with recurrent CDAD infection compared with those in patients who are initially infected.
Design
The study cohort consisted of all adult patients more than 18 years old with CDAD (by ICD9 code) who had been hospitalized at Brigham and Women's Hospital between 1997 and 2004. Retrospectively, patients were identified through the Partners Healthcare Research Patient Data Repository (RPDR). The RPDR is a centralized clinical data registry that gathers data from various hospital legacy systems and was used to determine the patient demographics and first date of treatment (with vancomycin or metronidazole). Medical and microbiologic records were reviewed to determine the dates of cytotoxic assay submission and symptom onset. Symptoms were defined as diarrhea, abdominal pain/cramping, or radiological/colonoscopic evidence of colitis. Recurrence was defined as any repeat inpatient CDAD diagnosis within 2 months (regardless of admission diagnosis). Baseline characteristics in the recurrence and no‐recurrence populations were compared by the 2‐sided Student t test or the chi‐square test (for continuous and categorical variables, respectively). Mean time from symptom to sampling, from symptom to treatment, and from sampling to treatment were compared between initial and recurrent disease episodes by the 2‐sided Student t test. All P values < .05 were considered significant. Institutional review board approval was obtained by Partners Healthcare.
RESULTS
Between 1997 and 2004 there were 1309 patients with an ICD9 code for CDAD, 151 of whom (12%) had a recurrence. Of these, 125 had 1 recurrence, 23 had 2 recurrences, and 3 had 3 recurrences. There were no significant differences between the groups in basic demographics (Table 1). The mean time to sampling was not significantly different between initial and recurrent CDAD hospital episodes (Table 2). However, the mean time to treatment (from symptoms and sampling) was shorter in recurrent episodes (Table 2). From 1997 to 2004 there was no significant reduction in time to sampling, but there was a significant reduction in time to treatment, from 3.89 days (19972000) to 2.30 days (2001 2004), P = .0012.
| Characteristic | Patients without recurrent disease (n = 1158) | Patients with recurrent disease (n = 151) | P value |
|---|---|---|---|
| Sex (% male) | 45% | 45% | .98 |
| Age (mean) | 68.3 years | 69.9 years | .72 |
| Race (% white) | 80% | 80% | .97 |
| Language (English) | 94% | 92% | .83 |
| First episode (n = 1309) | Recurrence (n = 180)* | P value | |
|---|---|---|---|
| |||
| Symptoms to sampling | 2.24 days (117 days) | 2.09 days (116 days) | 0.700 |
| Symptoms to treatment | 3.64 days (118 days) | 2.52 days (119 days) | 0.024 |
| Sampling to treatment | 3.76 days (119 days) | 2.57 days (119 days) | 0.006 |
DISCUSSION
Clostridium difficileassociated disease (CDAD) has become a significant nosocomial infection in medical institutions, and recurrent CDAD is emerging as a disease of concern for hospitalists. Diagnostic delays represent a major epidemiologic problem, resulting in both delay of treatment delay of the index case and delay in implementing isolation procedures to prevent horizontal transmission. In this study, patients with recurrent disease did not have stool collected any earlier than did patients with their initial episode of CDAD, and these diagnostic delays did not change in successive eras. Recurrent disease patients did receive treatment earlier than did patients with initial episodes. Although this empiric treatment strategy is encouraging and likely reflects heightened awareness of the disease over time, the 2.5‐day span from symptoms to treatment is still a clinically significant delay. Also of concern is the range of time from symptoms to treatment, as long as 19 days in the recurrent treatment group. Although most patients were treated within 12 days, this variability represents the burden of infectious patients with the potential for infecting others. Targeting recurrent CDAD populations for early diagnosis, treatment, and isolation would almost certainly reduce the morbidity associated with horizontal transmission rates.9
This study had several limitations. Our data found a lower incidence of recurrent CDAD than previously published in the literature. This can be accounted for by the identification of cases by ICD9 code, which previously has been documented to underestimate true disease.10, 11 We also were not able to capture recurrent episodes in outpatients or episodes that occurred after the 2004 cohort, which underestimated the true frequency of recurrence. At worst, this underestimation could bias the results toward the null hypothesis. An additional limitation of the study was the assumption that time to treatment was accurately reflected by time to prescription of either vancomycin or flagyl. Some patients may have been treated by suspending treatment with the offending antibiotic along with watchful waiting, which is a reasonable strategy for patients with mild disease and is endorsed by the American College of Gastroenterology and the Society for Healthcare Epidemiology of America.12, 13 This would overestimate time to treatment for those individuals and would make time to treatment appear longer, but would not affect time to sampling. In addition, the symptoms collected from chart review were assumed to be a result of the patient's CDAD, but there is a chance that these symptoms such as diarrhea, abdominal pain, and cramping may have been a result of a different diagnosis. These data were also limited to a cohort from a single institution and may not reflect the patient characteristics or practice patterns at other institutions.
In conclusion, CDAD is a major contributor to morbidity from nosocomial infections, and recurrent CDAD patients are a likely source of horizontal disease transmission. This study documented that there are significant diagnostic and treatment delays, even in populations with recurrent disease. It is especially important that hospitalists take measures to improve the early diagnosis, treatment, and isolation of these patients in order to improve these deficiencies in care.
- ,,,.Ten years of prospective Clostridium difficile‐associated disease surveillance and treatment at the Minneapolis VA Medical Center, 1982–1991.Infect Control Hosp Epidemiol.1994;15:371–381.
- ,,,.Health care costs and mortality associated with nosocomial diarrhea due to clostridium difficile.Clin Infect Dis.2002;34:346–353.
- ,,, et al.Nosocomial Clostridium difficile colonization and disease.Lancet.1990;336:97–100.
- ,,,.Asymptomatic carriage of Clostridium difficile and serum levels of IgG antibody against Toxin A.N Engl J Med.2000;342:390–397.
- ,,,.Nosocomial acquisition of Clostridium difficile infection.N Engl J Med.1989;320:204–210.
- ,.Reducing delays in the diagnosis and treatment of Clostridium difficile diarrhoea.QJM.2003;96:579–582.
- ,,, et al.Multicenter evaluation of four methods for Clostridium difficile detection: ImmunoCard C. difficile, cytotoxin assay, culture, and latex agglutination.J Clin Microbiol.1996;34:2718–2721.
- ,,, et al.Epidemiology of recurrences or reinfections of Clostridium difficile–associated diarrhea.J Clin Microbiol.2000;38:2386–2388.
- ,,, et al.Evaluation of Clostridium difficile‐associated disease pressure as a risk factor for C difficile–associated disease.Arch Intern Med.2007;167:1092–1097.
- ,,,.Accuracy of ICD9 coding for Clostridium difficile infections.Epidemiol Infect.2006;135:1010–1013.
- Emerging Infectious Diseases online publication Available at: http://www.cdc.gov/ncidod/EID/vol12no10/06‐0016.htm. Accessed July 12,2007.
- .Guidelines for the diagnosis and management of Clostridium difficile–associated diarrhea and colitis.American College of Gastroenterology, Practice Parameters Committee.Am J Gastroenterol.1997;92:739–750.
- ,,,,.SHEA position paper. Clostridium difficile associated diarrhea and colitis.Infect Control Hosp Epidemiol.1995;16:459–477.
- ,,,.Ten years of prospective Clostridium difficile‐associated disease surveillance and treatment at the Minneapolis VA Medical Center, 1982–1991.Infect Control Hosp Epidemiol.1994;15:371–381.
- ,,,.Health care costs and mortality associated with nosocomial diarrhea due to clostridium difficile.Clin Infect Dis.2002;34:346–353.
- ,,, et al.Nosocomial Clostridium difficile colonization and disease.Lancet.1990;336:97–100.
- ,,,.Asymptomatic carriage of Clostridium difficile and serum levels of IgG antibody against Toxin A.N Engl J Med.2000;342:390–397.
- ,,,.Nosocomial acquisition of Clostridium difficile infection.N Engl J Med.1989;320:204–210.
- ,.Reducing delays in the diagnosis and treatment of Clostridium difficile diarrhoea.QJM.2003;96:579–582.
- ,,, et al.Multicenter evaluation of four methods for Clostridium difficile detection: ImmunoCard C. difficile, cytotoxin assay, culture, and latex agglutination.J Clin Microbiol.1996;34:2718–2721.
- ,,, et al.Epidemiology of recurrences or reinfections of Clostridium difficile–associated diarrhea.J Clin Microbiol.2000;38:2386–2388.
- ,,, et al.Evaluation of Clostridium difficile‐associated disease pressure as a risk factor for C difficile–associated disease.Arch Intern Med.2007;167:1092–1097.
- ,,,.Accuracy of ICD9 coding for Clostridium difficile infections.Epidemiol Infect.2006;135:1010–1013.
- Emerging Infectious Diseases online publication Available at: http://www.cdc.gov/ncidod/EID/vol12no10/06‐0016.htm. Accessed July 12,2007.
- .Guidelines for the diagnosis and management of Clostridium difficile–associated diarrhea and colitis.American College of Gastroenterology, Practice Parameters Committee.Am J Gastroenterol.1997;92:739–750.
- ,,,,.SHEA position paper. Clostridium difficile associated diarrhea and colitis.Infect Control Hosp Epidemiol.1995;16:459–477.
In the Literature
In This Edition
- Pay-for-performance associated with limited benefits on quality in acute myocardial infarction patients.
- Meta-analysis finds increased risk of acute myocardial infarction with use of rosiglitazone.
- Rosiglitazone increases risk of heart failure, but not acute myocardial infarction or death, interim analysis shows.
- Surgery versus prolonged conservative treatment for severe sciatica.
- Predicting poor outcomes in upper gastrointestinal bleeds.
- Discharging patients with unresolved medical issues.
Does Pay for Performance Improve Hospital Quality?
Background: In 2003, the Centers for Medicare and Medicaid Services (CMS) instituted a pay-for-performance (P4P) pilot program in which participating hospitals would be reimbursed more if they met specific quality standards of care for patients with certain conditions, including acute myocardial infarction (AMI). It is unknown if this type of financial incentive produces improvements in the processes or outcomes of care.
Study design: Observational cohort.
Setting: 500 hospitals across the U.S.
Synopsis: This study compared compliance with CMS quality indicators in the treatment of more than 100,000 patients with acute non-ST-elevation myocardial infarction at 54 participating and 446 non-participating hospitals in the P4P pilot. They found no significant difference in mortality or in a composite measure of the six quality indicators but a slight improvement in two of the six quality indicators (aspirin at discharge and smoking cessation counseling). They did not find that P4P adversely affected indicators not subject to financial incentives.
Bottom line: P4P is associated with limited improvements in compliance with CMS quality indicators in patients with AMI.
Citation: Glickman SW, Ou F-S, DeLong ER, et al. Pay for performance, quality of care, and outcomes in acute myocardial infarction. JAMA. 2007 Jun;297(21):2373-2380.
Is Rosiglitazone Associated with Adverse Cardiovascular Outcomes in a Meta-analysis?
Background: Rosiglitazone (Avandia) is one of two approved oral thiazolidinedione drugs used for diabetic control. Muraglitazar, another thiazolidinedione drug, was not approved for market due to adverse cardiovascular outcomes. The cardiovascular effects of rosiglitazone had not previously been evaluated.
Study design: Meta-analysis.
Setting: All clinical trials (published and unpublished) involving rosiglitazone.
Synopsis: The authors reviewed data from all randomized trials of rosiglitazone versus placebo or other drugs for at least 24 weeks. From the 42 included trials (including more than 28,000 patients) researchers found a statistically significant increased risk of the odds of AMI (odds ratio 1.43, confidence interval 1.03-1.98) in the rosiglitazone group, and a non-significant risk of death from any cardiovascular cause (odds ratio 1.64, confidence interval 0.98-2.74) and all-cause mortality (odds ratio 1.18, confidence interval 0.89-1.55). The meta-analysis was criticized due to the small number of events (fewer than 100 acute AMIs in each group) and lack of patient-level data, but one expert wrote that “in view of the potential cardiovascular risks and in the absence of evidence of other health advantages ... the rationale for prescribing rosiglitazone at this time is unclear.”
The study raised larger concerns regarding Food and Drug Administration drug approvals, because the drug was approved due to its effect on lowering blood sugar levels (a surrogate outcome) without enough scrutiny of other patient outcomes.
Bottom line: Rosiglitazone is associated with increased risk of AMI. Alternative oral agents should be considered first for blood sugar control in diabetics.
Citation: Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007 Jun;356(24):2457-2471.
Editorial: Psaty BM, Furberg CD. Rosiglitazone and cardiovascular risk. N Engl J Med. 2007 Jun;356(24):2522-2524.
Is Rosiglitazone Associated with Adverse Cardiovascular Outcomes in Interim Analysis?
Background: In response to a meta-analysis, an interim analysis of an ongoing open-label manufacturer-sponsored trial was undertaken to determine the cardiovascular risks of rosiglitazone.
Study design: Unplanned interim analysis of a randomized, multicenter, open-label, non-inferiority trial.
Subjects: Outpatient, inadequately controlled type 2 diabetics.
Synopsis: This was an unplanned interim analysis of an open-label manufacturer-sponsored trial. There were 4,447 inadequately controlled type 2 diabetics on either metformin or sulfonylurea. The patients were randomized to receive both drugs (controls) or add-on rosiglitazone. After a mean follow up of 3.75 years, there was no statistically significant difference between the groups in the primary end point (hospitalization or death from cardiovascular causes), or other end points (MI and death from cardiovascular causes or any cause). However, rosiglitazone was associated with an increased risk of heart failure (hazard ratio 2.15, confidence interval 1.30-3.57). Because this was an unplanned interim analysis for a trial expected to continue for six years, experts caution that the results are inconclusive due to low statistical significance and small event rates.
Bottom line: Rosiglitazone is associated with an increased risk of heart failure, but the risks of hospitalization, death, and acute MI remain unclear.
Citation: Home PD, Phil D, Pockock SJ, et al. Rosiglitazone evaluated for cardiovascular outcomes—an interim analysis. N Engl J Med. 2007 Jul;357(1):28-38.
How Often do Discharged Patients with Unresolved Medical Issues Require Outpatient Workups?
Background: Patients are often discharged from the hospital with incomplete workups, but it is unknown how often and what factors affect the completion of the intended workup.
Study design: Retrospective cohort.
Setting: Single institution teaching hospital.
Synopsis: The authors evaluated the inpatient and outpatient medical records of all patients discharged from the medicine or geriatric service over 18 months. Of almost 700 discharges, 28% of the patients had outpatient workups recommended (48% diagnostic procedures, 35% referrals, and 17% lab tests) by the discharging physician. Completion of the workup did not occur 36% of the time, and the likelihood of non-completion increased with time to the first follow-up appointment and lack of availability of the discharge summary.
Bottom line: Outpatient workups are intended in almost a third of discharged patient, the completion of which can likely be enhanced by timely follow-up and discharge summary availability.
Citation: Moore C, McGinn T, Halm E. Tying up loose ends: discharging patients with unresolved medical issues. Arch Intern Med. 2007;167(12):1305-1311.
Can We Predict Patients at Low Risk for Compli-cations from Acute Upper Gastrointestinal Bleeds?
Background: Although multiple risk-prediction scales exist for patients with upper gastrointestinal (UGI) bleeds, few have been prospectively validated or widely used in clinical practice.
Study design: Prospective cohort.
Setting: Veterans Affairs (VA) hospitals.
Synopsis: VA researchers created and validated a risk predictor in 391 patients with acute upper gastrointestinal bleeding. Data from the derivation set (two-thirds of the patients) was used to create the model tested on the validation set (one-third of the patients). Outcome one (re-bleeding, need for intervention to stop bleeding, or all-cause hospital mortality) was predicted by an APACHE score >11, stigmata of recent bleeding, or varices. Outcome two (outcome one plus new/worsening co-morbidity) was predicted by the above three factors plus an unstable co-morbidity at admission. In the validation group, outcome one occurred in 1%, 5%, and 25% of patients with zero, one, and two or more factors. Outcome two occurred in 6%, 18%, and 49%, respectively. A score of zero accurately identified 93% and 91% of patients for outcomes one and two. The authors speculated that these patients could be safely treated as outpatients. The study excluded patients on anticoagulation, and this VA cohort (99% male) may not be generalizable to other populations.
Bottom line: This validated prediction model can accurately predict more than 90% of patients at low-risk of poor outcomes with UGI bleeding, which could be used to stratify patients in need of hospital admission.
Citation: Imperiale TF, Dominitz JA, Provenzale DT, et al. Predicting poor outcome from acute upper gastrointestinal hemorrhage. Arch Intern Med. 2007 Jun;167(12):1291-1296.
Does Surgery or Conservative Therapy Improve Symptoms of Sciatica Faster?
Background: The optimal timing and benefit of lumbar-disk surgery in patients with symptomatic lumbar disk herniation is unknown.
Study design: Multicenter randomized trial.
Setting: Netherlands.
Synopsis: 283 patients with severe sciatica were randomly chosen to receive early surgery or conservative treatment (with surgery as needed) for six to 12 weeks. The methods for determining the three primary outcomes were: score on the Roland Disability Questionnaire, leg pain score, and self-report of perceived recovery. At one year, 89% of the surgery group and 39% of the control group underwent surgery after a mean of 2.2 and 18.7 weeks, respectively. There was no difference between the groups in the disability score, but time to relief of leg pain and recovery was faster in the surgery group. At one year, 95% in each group reported perceived recovery.
Bottom line: Rates of pain relief and perceived recovery are faster with early surgery than conservative treatment in patients with severe sciatica, but one-year recovery rates are the same. TH
Citation: Peul WC, Van Houwelingen HC, van den Hout WB, et al. Surgery versus prolonged conservative treatment for sciatica. NEJM. 2007 May;356(22):2245-2256.
In This Edition
- Pay-for-performance associated with limited benefits on quality in acute myocardial infarction patients.
- Meta-analysis finds increased risk of acute myocardial infarction with use of rosiglitazone.
- Rosiglitazone increases risk of heart failure, but not acute myocardial infarction or death, interim analysis shows.
- Surgery versus prolonged conservative treatment for severe sciatica.
- Predicting poor outcomes in upper gastrointestinal bleeds.
- Discharging patients with unresolved medical issues.
Does Pay for Performance Improve Hospital Quality?
Background: In 2003, the Centers for Medicare and Medicaid Services (CMS) instituted a pay-for-performance (P4P) pilot program in which participating hospitals would be reimbursed more if they met specific quality standards of care for patients with certain conditions, including acute myocardial infarction (AMI). It is unknown if this type of financial incentive produces improvements in the processes or outcomes of care.
Study design: Observational cohort.
Setting: 500 hospitals across the U.S.
Synopsis: This study compared compliance with CMS quality indicators in the treatment of more than 100,000 patients with acute non-ST-elevation myocardial infarction at 54 participating and 446 non-participating hospitals in the P4P pilot. They found no significant difference in mortality or in a composite measure of the six quality indicators but a slight improvement in two of the six quality indicators (aspirin at discharge and smoking cessation counseling). They did not find that P4P adversely affected indicators not subject to financial incentives.
Bottom line: P4P is associated with limited improvements in compliance with CMS quality indicators in patients with AMI.
Citation: Glickman SW, Ou F-S, DeLong ER, et al. Pay for performance, quality of care, and outcomes in acute myocardial infarction. JAMA. 2007 Jun;297(21):2373-2380.
Is Rosiglitazone Associated with Adverse Cardiovascular Outcomes in a Meta-analysis?
Background: Rosiglitazone (Avandia) is one of two approved oral thiazolidinedione drugs used for diabetic control. Muraglitazar, another thiazolidinedione drug, was not approved for market due to adverse cardiovascular outcomes. The cardiovascular effects of rosiglitazone had not previously been evaluated.
Study design: Meta-analysis.
Setting: All clinical trials (published and unpublished) involving rosiglitazone.
Synopsis: The authors reviewed data from all randomized trials of rosiglitazone versus placebo or other drugs for at least 24 weeks. From the 42 included trials (including more than 28,000 patients) researchers found a statistically significant increased risk of the odds of AMI (odds ratio 1.43, confidence interval 1.03-1.98) in the rosiglitazone group, and a non-significant risk of death from any cardiovascular cause (odds ratio 1.64, confidence interval 0.98-2.74) and all-cause mortality (odds ratio 1.18, confidence interval 0.89-1.55). The meta-analysis was criticized due to the small number of events (fewer than 100 acute AMIs in each group) and lack of patient-level data, but one expert wrote that “in view of the potential cardiovascular risks and in the absence of evidence of other health advantages ... the rationale for prescribing rosiglitazone at this time is unclear.”
The study raised larger concerns regarding Food and Drug Administration drug approvals, because the drug was approved due to its effect on lowering blood sugar levels (a surrogate outcome) without enough scrutiny of other patient outcomes.
Bottom line: Rosiglitazone is associated with increased risk of AMI. Alternative oral agents should be considered first for blood sugar control in diabetics.
Citation: Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007 Jun;356(24):2457-2471.
Editorial: Psaty BM, Furberg CD. Rosiglitazone and cardiovascular risk. N Engl J Med. 2007 Jun;356(24):2522-2524.
Is Rosiglitazone Associated with Adverse Cardiovascular Outcomes in Interim Analysis?
Background: In response to a meta-analysis, an interim analysis of an ongoing open-label manufacturer-sponsored trial was undertaken to determine the cardiovascular risks of rosiglitazone.
Study design: Unplanned interim analysis of a randomized, multicenter, open-label, non-inferiority trial.
Subjects: Outpatient, inadequately controlled type 2 diabetics.
Synopsis: This was an unplanned interim analysis of an open-label manufacturer-sponsored trial. There were 4,447 inadequately controlled type 2 diabetics on either metformin or sulfonylurea. The patients were randomized to receive both drugs (controls) or add-on rosiglitazone. After a mean follow up of 3.75 years, there was no statistically significant difference between the groups in the primary end point (hospitalization or death from cardiovascular causes), or other end points (MI and death from cardiovascular causes or any cause). However, rosiglitazone was associated with an increased risk of heart failure (hazard ratio 2.15, confidence interval 1.30-3.57). Because this was an unplanned interim analysis for a trial expected to continue for six years, experts caution that the results are inconclusive due to low statistical significance and small event rates.
Bottom line: Rosiglitazone is associated with an increased risk of heart failure, but the risks of hospitalization, death, and acute MI remain unclear.
Citation: Home PD, Phil D, Pockock SJ, et al. Rosiglitazone evaluated for cardiovascular outcomes—an interim analysis. N Engl J Med. 2007 Jul;357(1):28-38.
How Often do Discharged Patients with Unresolved Medical Issues Require Outpatient Workups?
Background: Patients are often discharged from the hospital with incomplete workups, but it is unknown how often and what factors affect the completion of the intended workup.
Study design: Retrospective cohort.
Setting: Single institution teaching hospital.
Synopsis: The authors evaluated the inpatient and outpatient medical records of all patients discharged from the medicine or geriatric service over 18 months. Of almost 700 discharges, 28% of the patients had outpatient workups recommended (48% diagnostic procedures, 35% referrals, and 17% lab tests) by the discharging physician. Completion of the workup did not occur 36% of the time, and the likelihood of non-completion increased with time to the first follow-up appointment and lack of availability of the discharge summary.
Bottom line: Outpatient workups are intended in almost a third of discharged patient, the completion of which can likely be enhanced by timely follow-up and discharge summary availability.
Citation: Moore C, McGinn T, Halm E. Tying up loose ends: discharging patients with unresolved medical issues. Arch Intern Med. 2007;167(12):1305-1311.
Can We Predict Patients at Low Risk for Compli-cations from Acute Upper Gastrointestinal Bleeds?
Background: Although multiple risk-prediction scales exist for patients with upper gastrointestinal (UGI) bleeds, few have been prospectively validated or widely used in clinical practice.
Study design: Prospective cohort.
Setting: Veterans Affairs (VA) hospitals.
Synopsis: VA researchers created and validated a risk predictor in 391 patients with acute upper gastrointestinal bleeding. Data from the derivation set (two-thirds of the patients) was used to create the model tested on the validation set (one-third of the patients). Outcome one (re-bleeding, need for intervention to stop bleeding, or all-cause hospital mortality) was predicted by an APACHE score >11, stigmata of recent bleeding, or varices. Outcome two (outcome one plus new/worsening co-morbidity) was predicted by the above three factors plus an unstable co-morbidity at admission. In the validation group, outcome one occurred in 1%, 5%, and 25% of patients with zero, one, and two or more factors. Outcome two occurred in 6%, 18%, and 49%, respectively. A score of zero accurately identified 93% and 91% of patients for outcomes one and two. The authors speculated that these patients could be safely treated as outpatients. The study excluded patients on anticoagulation, and this VA cohort (99% male) may not be generalizable to other populations.
Bottom line: This validated prediction model can accurately predict more than 90% of patients at low-risk of poor outcomes with UGI bleeding, which could be used to stratify patients in need of hospital admission.
Citation: Imperiale TF, Dominitz JA, Provenzale DT, et al. Predicting poor outcome from acute upper gastrointestinal hemorrhage. Arch Intern Med. 2007 Jun;167(12):1291-1296.
Does Surgery or Conservative Therapy Improve Symptoms of Sciatica Faster?
Background: The optimal timing and benefit of lumbar-disk surgery in patients with symptomatic lumbar disk herniation is unknown.
Study design: Multicenter randomized trial.
Setting: Netherlands.
Synopsis: 283 patients with severe sciatica were randomly chosen to receive early surgery or conservative treatment (with surgery as needed) for six to 12 weeks. The methods for determining the three primary outcomes were: score on the Roland Disability Questionnaire, leg pain score, and self-report of perceived recovery. At one year, 89% of the surgery group and 39% of the control group underwent surgery after a mean of 2.2 and 18.7 weeks, respectively. There was no difference between the groups in the disability score, but time to relief of leg pain and recovery was faster in the surgery group. At one year, 95% in each group reported perceived recovery.
Bottom line: Rates of pain relief and perceived recovery are faster with early surgery than conservative treatment in patients with severe sciatica, but one-year recovery rates are the same. TH
Citation: Peul WC, Van Houwelingen HC, van den Hout WB, et al. Surgery versus prolonged conservative treatment for sciatica. NEJM. 2007 May;356(22):2245-2256.
In This Edition
- Pay-for-performance associated with limited benefits on quality in acute myocardial infarction patients.
- Meta-analysis finds increased risk of acute myocardial infarction with use of rosiglitazone.
- Rosiglitazone increases risk of heart failure, but not acute myocardial infarction or death, interim analysis shows.
- Surgery versus prolonged conservative treatment for severe sciatica.
- Predicting poor outcomes in upper gastrointestinal bleeds.
- Discharging patients with unresolved medical issues.
Does Pay for Performance Improve Hospital Quality?
Background: In 2003, the Centers for Medicare and Medicaid Services (CMS) instituted a pay-for-performance (P4P) pilot program in which participating hospitals would be reimbursed more if they met specific quality standards of care for patients with certain conditions, including acute myocardial infarction (AMI). It is unknown if this type of financial incentive produces improvements in the processes or outcomes of care.
Study design: Observational cohort.
Setting: 500 hospitals across the U.S.
Synopsis: This study compared compliance with CMS quality indicators in the treatment of more than 100,000 patients with acute non-ST-elevation myocardial infarction at 54 participating and 446 non-participating hospitals in the P4P pilot. They found no significant difference in mortality or in a composite measure of the six quality indicators but a slight improvement in two of the six quality indicators (aspirin at discharge and smoking cessation counseling). They did not find that P4P adversely affected indicators not subject to financial incentives.
Bottom line: P4P is associated with limited improvements in compliance with CMS quality indicators in patients with AMI.
Citation: Glickman SW, Ou F-S, DeLong ER, et al. Pay for performance, quality of care, and outcomes in acute myocardial infarction. JAMA. 2007 Jun;297(21):2373-2380.
Is Rosiglitazone Associated with Adverse Cardiovascular Outcomes in a Meta-analysis?
Background: Rosiglitazone (Avandia) is one of two approved oral thiazolidinedione drugs used for diabetic control. Muraglitazar, another thiazolidinedione drug, was not approved for market due to adverse cardiovascular outcomes. The cardiovascular effects of rosiglitazone had not previously been evaluated.
Study design: Meta-analysis.
Setting: All clinical trials (published and unpublished) involving rosiglitazone.
Synopsis: The authors reviewed data from all randomized trials of rosiglitazone versus placebo or other drugs for at least 24 weeks. From the 42 included trials (including more than 28,000 patients) researchers found a statistically significant increased risk of the odds of AMI (odds ratio 1.43, confidence interval 1.03-1.98) in the rosiglitazone group, and a non-significant risk of death from any cardiovascular cause (odds ratio 1.64, confidence interval 0.98-2.74) and all-cause mortality (odds ratio 1.18, confidence interval 0.89-1.55). The meta-analysis was criticized due to the small number of events (fewer than 100 acute AMIs in each group) and lack of patient-level data, but one expert wrote that “in view of the potential cardiovascular risks and in the absence of evidence of other health advantages ... the rationale for prescribing rosiglitazone at this time is unclear.”
The study raised larger concerns regarding Food and Drug Administration drug approvals, because the drug was approved due to its effect on lowering blood sugar levels (a surrogate outcome) without enough scrutiny of other patient outcomes.
Bottom line: Rosiglitazone is associated with increased risk of AMI. Alternative oral agents should be considered first for blood sugar control in diabetics.
Citation: Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007 Jun;356(24):2457-2471.
Editorial: Psaty BM, Furberg CD. Rosiglitazone and cardiovascular risk. N Engl J Med. 2007 Jun;356(24):2522-2524.
Is Rosiglitazone Associated with Adverse Cardiovascular Outcomes in Interim Analysis?
Background: In response to a meta-analysis, an interim analysis of an ongoing open-label manufacturer-sponsored trial was undertaken to determine the cardiovascular risks of rosiglitazone.
Study design: Unplanned interim analysis of a randomized, multicenter, open-label, non-inferiority trial.
Subjects: Outpatient, inadequately controlled type 2 diabetics.
Synopsis: This was an unplanned interim analysis of an open-label manufacturer-sponsored trial. There were 4,447 inadequately controlled type 2 diabetics on either metformin or sulfonylurea. The patients were randomized to receive both drugs (controls) or add-on rosiglitazone. After a mean follow up of 3.75 years, there was no statistically significant difference between the groups in the primary end point (hospitalization or death from cardiovascular causes), or other end points (MI and death from cardiovascular causes or any cause). However, rosiglitazone was associated with an increased risk of heart failure (hazard ratio 2.15, confidence interval 1.30-3.57). Because this was an unplanned interim analysis for a trial expected to continue for six years, experts caution that the results are inconclusive due to low statistical significance and small event rates.
Bottom line: Rosiglitazone is associated with an increased risk of heart failure, but the risks of hospitalization, death, and acute MI remain unclear.
Citation: Home PD, Phil D, Pockock SJ, et al. Rosiglitazone evaluated for cardiovascular outcomes—an interim analysis. N Engl J Med. 2007 Jul;357(1):28-38.
How Often do Discharged Patients with Unresolved Medical Issues Require Outpatient Workups?
Background: Patients are often discharged from the hospital with incomplete workups, but it is unknown how often and what factors affect the completion of the intended workup.
Study design: Retrospective cohort.
Setting: Single institution teaching hospital.
Synopsis: The authors evaluated the inpatient and outpatient medical records of all patients discharged from the medicine or geriatric service over 18 months. Of almost 700 discharges, 28% of the patients had outpatient workups recommended (48% diagnostic procedures, 35% referrals, and 17% lab tests) by the discharging physician. Completion of the workup did not occur 36% of the time, and the likelihood of non-completion increased with time to the first follow-up appointment and lack of availability of the discharge summary.
Bottom line: Outpatient workups are intended in almost a third of discharged patient, the completion of which can likely be enhanced by timely follow-up and discharge summary availability.
Citation: Moore C, McGinn T, Halm E. Tying up loose ends: discharging patients with unresolved medical issues. Arch Intern Med. 2007;167(12):1305-1311.
Can We Predict Patients at Low Risk for Compli-cations from Acute Upper Gastrointestinal Bleeds?
Background: Although multiple risk-prediction scales exist for patients with upper gastrointestinal (UGI) bleeds, few have been prospectively validated or widely used in clinical practice.
Study design: Prospective cohort.
Setting: Veterans Affairs (VA) hospitals.
Synopsis: VA researchers created and validated a risk predictor in 391 patients with acute upper gastrointestinal bleeding. Data from the derivation set (two-thirds of the patients) was used to create the model tested on the validation set (one-third of the patients). Outcome one (re-bleeding, need for intervention to stop bleeding, or all-cause hospital mortality) was predicted by an APACHE score >11, stigmata of recent bleeding, or varices. Outcome two (outcome one plus new/worsening co-morbidity) was predicted by the above three factors plus an unstable co-morbidity at admission. In the validation group, outcome one occurred in 1%, 5%, and 25% of patients with zero, one, and two or more factors. Outcome two occurred in 6%, 18%, and 49%, respectively. A score of zero accurately identified 93% and 91% of patients for outcomes one and two. The authors speculated that these patients could be safely treated as outpatients. The study excluded patients on anticoagulation, and this VA cohort (99% male) may not be generalizable to other populations.
Bottom line: This validated prediction model can accurately predict more than 90% of patients at low-risk of poor outcomes with UGI bleeding, which could be used to stratify patients in need of hospital admission.
Citation: Imperiale TF, Dominitz JA, Provenzale DT, et al. Predicting poor outcome from acute upper gastrointestinal hemorrhage. Arch Intern Med. 2007 Jun;167(12):1291-1296.
Does Surgery or Conservative Therapy Improve Symptoms of Sciatica Faster?
Background: The optimal timing and benefit of lumbar-disk surgery in patients with symptomatic lumbar disk herniation is unknown.
Study design: Multicenter randomized trial.
Setting: Netherlands.
Synopsis: 283 patients with severe sciatica were randomly chosen to receive early surgery or conservative treatment (with surgery as needed) for six to 12 weeks. The methods for determining the three primary outcomes were: score on the Roland Disability Questionnaire, leg pain score, and self-report of perceived recovery. At one year, 89% of the surgery group and 39% of the control group underwent surgery after a mean of 2.2 and 18.7 weeks, respectively. There was no difference between the groups in the disability score, but time to relief of leg pain and recovery was faster in the surgery group. At one year, 95% in each group reported perceived recovery.
Bottom line: Rates of pain relief and perceived recovery are faster with early surgery than conservative treatment in patients with severe sciatica, but one-year recovery rates are the same. TH
Citation: Peul WC, Van Houwelingen HC, van den Hout WB, et al. Surgery versus prolonged conservative treatment for sciatica. NEJM. 2007 May;356(22):2245-2256.
Urine for a Surprise
A58-year-old white female presented with a two-week history of severe fatigue. She was admitted for acute renal failure (creatinine of 3.0 mg/dL with baseline 0.9 mg/dL two months prior) and anemia (hematocrit of 27.9 with baseline 37.5 two month prior). She had no prior history of renal failure. Her review of systems was otherwise negative. Her urine was orange and dipstick was positive for bilirubin but serum bilirubin was normal. (See photo at right.) Blood smear showed schistocytes and haptoglobin was undetectable. Physical exam showed yellow sclera, but was otherwise normal.
What is the most appropriate treatment for this patient?
- Draw serum complement levels and spin urine for sediment analysis;
- Order a STAT renal ultrasound;
- Ask the patient about over-the-counter medication use;
- Check urine porphyrin levels; or
- Order immediate referral for plasmapheresis.
Discussion
The answer is C: Ask the patient about over-the-counter (OTC) medication use. This patient’s presentation was consistent with overuse of phenazopyridine. Phenazopyridine is an azo dye, which appears to exert a local anesthetic action on urinary tract mucosa. It’s reported adverse reactions include acute renal failure, hemolytic anemia, hepatitis, and methemoglobinemia, which have been reported after acute ingestions, chronic overdoses, and in chronically appropriate doses.1-7 The mechanism of these adverse reactions is not well understood. Although the differential diagnosis for renal failure and hemolytic anemia is extensive, yellow sclera and orange urine in the setting of a normal bilirubin level raised the suspicion of phenazopyridine use in this patient.
This case highlights the common overuse of over the counter medications, as well as global lack of knowledge of their potential adverse reactions. Although phenazopyridine is widely used, 50% of product consumers do not know that it is a urinary tract analgesic, and 80% do not know either the cause of their symptoms or the action of the drug.8
Additionally, although OTC medication use is reported by two-thirds of all hospitalized patients, documentation of them is present in only 10% of admission paperwork.9-10 Given that drug related hospitalizations account for 5%-8% of all hospital stays, it is essential that a complete OTC medication list be included as a routine part of the history obtained from all patients at the time of hospital admission.11-12 With history taking vigilance and patient education, adverse events from OTC medications can be minimized. TH
References
- Gabor EP, Lowenstein L, De Leeuw NK. Hemolytic anemia induced by Phenylazo-Diamino-Pyridine (Pyridium). Can Med Assoc J. 1964 Oct;91:756-759.
- Nathan DM, Siegel AJ, Bunn HF. Acute methemoglobinemia and hemolytic anemia with phenazopyridine: possible relation to acute renal failure. Arch Int Med. 1977 Nov;137(11):1636-1638.
- Gavish D, Knobler H, Gottehrer N, et al. Methemoglobinemia, muscle damage and renal failure complicating phenazopyridine overdose. Isr J Med Sci. 1986 Jan;22(1):45-47.
- Vega J. Acute Renal Failure caused by phenazopyridine. Rev Med Chil. 2003 May;131(5):541-544.
- Kornowski R, Averbuch M, Jaffe A, et al. Sedural toxicity. Harefuah. 1991 Mar 15;120(6):324-325.
- Thomas RJ, Doddabele S, Karnad AB. Chronic severe hemolytic anemia related to surreptitious phenazopyridine abuse. Ann Int Med. 1994;121:308.
- Landman J, Kavaler E, Waterhouse R. Acquired methemoglobinemia possibly related to phenazopyridine in a woman with normal renal function. J Urol. 1997 Oct;158(4):1520-1521.
- Chih-Wen S, Asch SM, Fielder E, et al. Consumer knowledge of over-the-counter phenazopyridine. Ann Fam Med. 2004 May-Jun;2(3):240-244.
- Chrischilles EA, Foley DJ, Wallace RB, et al. Use of medications by persons 65 and over; data from the established populations for epidemiologic studies of the elderly. J Geront. 1992 Sep;47(5):M137-144.
- Simons LA, Tett S, Simons J, et al. Multiple medication use in the elderly. Use of prescription and non-prescription drugs in an Australian community setting. Med J Aust. 1992 Aug 17;157(4):242-246.
- Hallas J, Jensen KB, Grodum E, et al. Drug-related admissions to a department of medical gastroenterology. The role of self-medicated and prescribed drugs. Scand J Gastroenterol. 1991 Feb;26(2):174-180.
- Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ. 2004 Jul;329(7456):15-19.
A58-year-old white female presented with a two-week history of severe fatigue. She was admitted for acute renal failure (creatinine of 3.0 mg/dL with baseline 0.9 mg/dL two months prior) and anemia (hematocrit of 27.9 with baseline 37.5 two month prior). She had no prior history of renal failure. Her review of systems was otherwise negative. Her urine was orange and dipstick was positive for bilirubin but serum bilirubin was normal. (See photo at right.) Blood smear showed schistocytes and haptoglobin was undetectable. Physical exam showed yellow sclera, but was otherwise normal.
What is the most appropriate treatment for this patient?
- Draw serum complement levels and spin urine for sediment analysis;
- Order a STAT renal ultrasound;
- Ask the patient about over-the-counter medication use;
- Check urine porphyrin levels; or
- Order immediate referral for plasmapheresis.
Discussion
The answer is C: Ask the patient about over-the-counter (OTC) medication use. This patient’s presentation was consistent with overuse of phenazopyridine. Phenazopyridine is an azo dye, which appears to exert a local anesthetic action on urinary tract mucosa. It’s reported adverse reactions include acute renal failure, hemolytic anemia, hepatitis, and methemoglobinemia, which have been reported after acute ingestions, chronic overdoses, and in chronically appropriate doses.1-7 The mechanism of these adverse reactions is not well understood. Although the differential diagnosis for renal failure and hemolytic anemia is extensive, yellow sclera and orange urine in the setting of a normal bilirubin level raised the suspicion of phenazopyridine use in this patient.
This case highlights the common overuse of over the counter medications, as well as global lack of knowledge of their potential adverse reactions. Although phenazopyridine is widely used, 50% of product consumers do not know that it is a urinary tract analgesic, and 80% do not know either the cause of their symptoms or the action of the drug.8
Additionally, although OTC medication use is reported by two-thirds of all hospitalized patients, documentation of them is present in only 10% of admission paperwork.9-10 Given that drug related hospitalizations account for 5%-8% of all hospital stays, it is essential that a complete OTC medication list be included as a routine part of the history obtained from all patients at the time of hospital admission.11-12 With history taking vigilance and patient education, adverse events from OTC medications can be minimized. TH
References
- Gabor EP, Lowenstein L, De Leeuw NK. Hemolytic anemia induced by Phenylazo-Diamino-Pyridine (Pyridium). Can Med Assoc J. 1964 Oct;91:756-759.
- Nathan DM, Siegel AJ, Bunn HF. Acute methemoglobinemia and hemolytic anemia with phenazopyridine: possible relation to acute renal failure. Arch Int Med. 1977 Nov;137(11):1636-1638.
- Gavish D, Knobler H, Gottehrer N, et al. Methemoglobinemia, muscle damage and renal failure complicating phenazopyridine overdose. Isr J Med Sci. 1986 Jan;22(1):45-47.
- Vega J. Acute Renal Failure caused by phenazopyridine. Rev Med Chil. 2003 May;131(5):541-544.
- Kornowski R, Averbuch M, Jaffe A, et al. Sedural toxicity. Harefuah. 1991 Mar 15;120(6):324-325.
- Thomas RJ, Doddabele S, Karnad AB. Chronic severe hemolytic anemia related to surreptitious phenazopyridine abuse. Ann Int Med. 1994;121:308.
- Landman J, Kavaler E, Waterhouse R. Acquired methemoglobinemia possibly related to phenazopyridine in a woman with normal renal function. J Urol. 1997 Oct;158(4):1520-1521.
- Chih-Wen S, Asch SM, Fielder E, et al. Consumer knowledge of over-the-counter phenazopyridine. Ann Fam Med. 2004 May-Jun;2(3):240-244.
- Chrischilles EA, Foley DJ, Wallace RB, et al. Use of medications by persons 65 and over; data from the established populations for epidemiologic studies of the elderly. J Geront. 1992 Sep;47(5):M137-144.
- Simons LA, Tett S, Simons J, et al. Multiple medication use in the elderly. Use of prescription and non-prescription drugs in an Australian community setting. Med J Aust. 1992 Aug 17;157(4):242-246.
- Hallas J, Jensen KB, Grodum E, et al. Drug-related admissions to a department of medical gastroenterology. The role of self-medicated and prescribed drugs. Scand J Gastroenterol. 1991 Feb;26(2):174-180.
- Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ. 2004 Jul;329(7456):15-19.
A58-year-old white female presented with a two-week history of severe fatigue. She was admitted for acute renal failure (creatinine of 3.0 mg/dL with baseline 0.9 mg/dL two months prior) and anemia (hematocrit of 27.9 with baseline 37.5 two month prior). She had no prior history of renal failure. Her review of systems was otherwise negative. Her urine was orange and dipstick was positive for bilirubin but serum bilirubin was normal. (See photo at right.) Blood smear showed schistocytes and haptoglobin was undetectable. Physical exam showed yellow sclera, but was otherwise normal.
What is the most appropriate treatment for this patient?
- Draw serum complement levels and spin urine for sediment analysis;
- Order a STAT renal ultrasound;
- Ask the patient about over-the-counter medication use;
- Check urine porphyrin levels; or
- Order immediate referral for plasmapheresis.
Discussion
The answer is C: Ask the patient about over-the-counter (OTC) medication use. This patient’s presentation was consistent with overuse of phenazopyridine. Phenazopyridine is an azo dye, which appears to exert a local anesthetic action on urinary tract mucosa. It’s reported adverse reactions include acute renal failure, hemolytic anemia, hepatitis, and methemoglobinemia, which have been reported after acute ingestions, chronic overdoses, and in chronically appropriate doses.1-7 The mechanism of these adverse reactions is not well understood. Although the differential diagnosis for renal failure and hemolytic anemia is extensive, yellow sclera and orange urine in the setting of a normal bilirubin level raised the suspicion of phenazopyridine use in this patient.
This case highlights the common overuse of over the counter medications, as well as global lack of knowledge of their potential adverse reactions. Although phenazopyridine is widely used, 50% of product consumers do not know that it is a urinary tract analgesic, and 80% do not know either the cause of their symptoms or the action of the drug.8
Additionally, although OTC medication use is reported by two-thirds of all hospitalized patients, documentation of them is present in only 10% of admission paperwork.9-10 Given that drug related hospitalizations account for 5%-8% of all hospital stays, it is essential that a complete OTC medication list be included as a routine part of the history obtained from all patients at the time of hospital admission.11-12 With history taking vigilance and patient education, adverse events from OTC medications can be minimized. TH
References
- Gabor EP, Lowenstein L, De Leeuw NK. Hemolytic anemia induced by Phenylazo-Diamino-Pyridine (Pyridium). Can Med Assoc J. 1964 Oct;91:756-759.
- Nathan DM, Siegel AJ, Bunn HF. Acute methemoglobinemia and hemolytic anemia with phenazopyridine: possible relation to acute renal failure. Arch Int Med. 1977 Nov;137(11):1636-1638.
- Gavish D, Knobler H, Gottehrer N, et al. Methemoglobinemia, muscle damage and renal failure complicating phenazopyridine overdose. Isr J Med Sci. 1986 Jan;22(1):45-47.
- Vega J. Acute Renal Failure caused by phenazopyridine. Rev Med Chil. 2003 May;131(5):541-544.
- Kornowski R, Averbuch M, Jaffe A, et al. Sedural toxicity. Harefuah. 1991 Mar 15;120(6):324-325.
- Thomas RJ, Doddabele S, Karnad AB. Chronic severe hemolytic anemia related to surreptitious phenazopyridine abuse. Ann Int Med. 1994;121:308.
- Landman J, Kavaler E, Waterhouse R. Acquired methemoglobinemia possibly related to phenazopyridine in a woman with normal renal function. J Urol. 1997 Oct;158(4):1520-1521.
- Chih-Wen S, Asch SM, Fielder E, et al. Consumer knowledge of over-the-counter phenazopyridine. Ann Fam Med. 2004 May-Jun;2(3):240-244.
- Chrischilles EA, Foley DJ, Wallace RB, et al. Use of medications by persons 65 and over; data from the established populations for epidemiologic studies of the elderly. J Geront. 1992 Sep;47(5):M137-144.
- Simons LA, Tett S, Simons J, et al. Multiple medication use in the elderly. Use of prescription and non-prescription drugs in an Australian community setting. Med J Aust. 1992 Aug 17;157(4):242-246.
- Hallas J, Jensen KB, Grodum E, et al. Drug-related admissions to a department of medical gastroenterology. The role of self-medicated and prescribed drugs. Scand J Gastroenterol. 1991 Feb;26(2):174-180.
- Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ. 2004 Jul;329(7456):15-19.