- Email: [email protected]
August abstracts
ABSTRACTS
The following abstracts from leading journals have been selected on the basis of their importance to the practice of obstetrics and gynecology.
Outcomes of screening to prevent cancer: Analysis of cumulative incidence of cervical abnormality and modelling of cases and deaths prevented OBJECTIVE: To determine the frequency of different outcomes in women participating in cervical screening. DESIGN: Analysis of screening records from 348 419 women, and modelling of cases of cervical cancer and deaths with and without screening. SETTING: Cervical screening programme in Bristol. RESULTS: For every 10 000 women screened from 1976 to 1996, 1564 had abnormal cytology, 818 were investigated, and 543 had abnormal histology. One hundred and seventy six had persistent abnormality for two years or more. In the absence of screening 80 women would be expected to develop cancer of the cervix by 2011, of whom 25 would die. With screening 10 of these deaths would be avoided. Comparison of cumulative abnormality rates with numbers expected to develop cancer in the absence of screening suggests that at least 80% of high grade dyskaryosis and of high grade dysplasia would not progress to cancer. The lifetime risk of having abnormal cytology detected could be as high as 40% for women born since 1960. CONCLUSIONS: Screening is labour and resource intensive. It involves treatment for many women not destined to develop invasive cancer. The increased intervention rate for cervical abnormality in England is due to change in practice, not a cohort effect, and is probably the reason for the marked fall in incidence and mortality during the 1990s. For other cancers there is scope for major iatrogenic harm from screening because of invasive tests and treatments. Raffle AE, Alden B, Quinn M, Babb PJ, Brett MT. BMJ 2003; 326(7395):901. (http://bmj.com)
Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial CONTEXT: Hypertensive patients are often given a calcium antagonist to reduce cardiovascular disease risk, but the benefit compared with other drug classes is controversial. OBJECTIVE: To determine whether initial therapy with controlled-onset extended-release (COER) verapamil is equivalent to a physician’s choice of atenolol or hydrochlorothiazide in preventing cardiovascular disease.
DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized clinical trial conducted at 661 centers in 15 countries. A total of 16 602 participants diagnosed as having hypertension and who had 1 or more additional risk factors for cardiovascular disease were enrolled between September 1996 and December 1998 and followed up until December 31, 2000. After a mean of 3 years of follow-up, the sponsor closed the study before unblinding the results. INTERVENTION: Initially, 8241 participants received 180 mg of COER verapamil and 8361 received either 50 mg of atenolol or 12.5 mg of hydrochlorothiazide. Other drugs (eg, diuretic, beta-blocker, or an angiotensin-converting enzyme inhibitor) could be added in specified sequence if needed. MAIN OUTCOME MEASURES: First occurrence of stroke, myocardial infarction, or cardiovascular disease-related death. RESULTS: Systolic and diastolic blood pressure were reduced by 13.6 mm Hg and 7.8 mm Hg for participants assigned to the COER verapamil group and by 13.5 and 7.1 mm Hg for partcipants assigned to the atenolol or hydrochlorothiazide group. There were 364 primary cardiovascular disease-related events that occurred in the COER verapamil group vs 365 in atenolol or hydrochlorothiazide group (hazard ratio [HR], 1.02; 95% confidence interval [CI], 0.88-1.18; P ⫽.77). For fatal or nonfatal stroke, the HR was 1.15 (95% CI, 0.90-1.48); for fatal or nonfatal myocardial infarction, 0.82 (95% CI, 0.651.03); and for cardiovascular disease-related death, 1.09 (95% CI, 0.87-1.37). The HR was 1.05 (95% CI, 0.95-1.16) for any prespecified cardiovascular disease-related event and 1.08 (95% CI, 0.93-1.26) for all-cause mortality. Nonstroke hemorrhage was more common with participants in the COERverapamil group (n ⫽ 118) compared with the atenolol or hydrochlorothiazide group (n ⫽ 79) (HR, 1.54 [95% CI, 1.162.04]; P ⫽.003). More cardiovascular disease-related events occurred between 6 AM and noon in both the COER verapamil (99/277) and atenolol or hydrochlorothiazide (88/274) groups; HR, 1.15 (95% CI, 0.86-1.53). CONCLUSIONS: The CONVINCE trial did not demonstrate equivalence of a COER verapamil-based antihypertensive regimen compared with a regimen beginning with a diuretic or beta-blocker. When considered in the context of other trials of calcium antagonists, these data indicate that the effectiveness of calcium-channel therapy in reducing cardiovascular disease is similar but not better than diuretic or beta-blocker treatment. Black HR, Elliott WJ, Grandits G, Grambsch P, Lucente T, White WB, et al. JAMA 2003;289:2073– 82. (http://jama.ama-assn.org)
Laparoscopic adhesiolysis in patients with chronic abdominal pain: A blinded randomised controlled multi-centre trial BACKGROUND: Laparoscopic adhesiolysis for chronic abdominal pain is controversial and is not evidence based. We aimed
VOL. 102, NO. 2, AUGUST 2003 © 2003 by The American College of Obstetricians and Gynecologists. Published by Elsevier.
0029-7844/03/$30.00 doi:10.1016/S0029-7844(03)00605-7
409
to test our hypothesis that laparoscopic adhesiolysis leads to substantial pain relief and improvement in quality of life in patients with adhesions and chronic abdominal pain. METHODS: Patients had diagnostic laparoscopy for chronic abdominal pain attributed to adhesions; other causes for their pain had been excluded. If adhesions were confirmed during diagnostic laparoscopy, patients were randomly assigned either to laparoscopic adhesiolysis or no treatment. Treatment allocation was concealed from patients, and assessors were unaware of patients’ treatment and outcome. Pain was assessed for 1 year by visual analogue score (VAS) score (scale 0-100), pain change score, use of analgesics, and quality of life score. Analysis was by intention to treat. FINDINGS: Of 116 patients enrolled for diagnostic laparoscopy, 100 were randomly allocated either laparoscopic adhesiolysis (52) or no treatment (48). Both groups reported substantial pain relief and a significantly improved quality of life, but there was no difference between the groups (mean change from baseline of VAS score at 12 months: difference 3 points, p⫽0.53; 95% CI -7 to 13). INTERPRETATION: Although laparoscopic adhesiolysis relieves chronic abdominal pain, it is not more beneficial than diagnostic laparoscopy alone. Therefore, laparoscopic adhesiolysis cannot be recommended as a treatment for adhesions in patients with chronic abdominal pain. Swank DJ, Swank-Bordewijk SC, Hop WC, van Erp WF, Janssen IM, Bonjer HJ, et al. Lancet 2003;361(9365):1247–51. (http://www.thelancet.com)
Hypertensive diseases of pregnancy and risk of hypertension and stroke in later life: Results from cohort study OBJECTIVE: To examine the association between hypertensive diseases of pregnancy (gestational hypertension and preeclampsia) and the development of circulatory diseases in later life. DESIGN: Cohort study of women who had pre-eclampsia during their first singleton pregnancy. Two comparison groups were matched for age and year of delivery, one with gestational hypertension and one with no history of raised blood pressure. SETTING: Maternity services in the Grampian region of Scotland. PARTICIPANTS: Women selected from the Aberdeen maternity and neonatal databank who were resident in Aberdeen and who delivered a first, live singleton from 1951 to 1970. MAIN OUTCOME MEASURES: Current vital and cardiovascular health status ascertained through postal questionnaire survey, clinical examination, linkage to hospital discharge, and mortality data. RESULTS: There were significant positive associations between pre-eclampsia/eclampsia or gestational hypertension and later hypertension in all measures. The adjusted relative risks varied from 1.13-3.72 for gestational hypertension and 1.403.98 for pre-eclampsia or eclampsia. The adjusted incident rate ratio for death from stroke for the pre-eclampsia/eclampsia group was 3.59 (95% confidence interval 1.04 to 12.4).
410
Abstracts
CONCLUSIONS: Hypertensive diseases of pregnancy seem to be associated in later life with diseases related to hypertension. If greater awareness of this association leads to earlier diagnosis and improved management, there may be scope for reducing a proportion of the morbidity and mortality from such diseases. Wilson BJ, Watson MS, Prescott GJ, Sunderland S, Campbell DM, Hannaford P, et al. BMJ 2003;326(7394):845. (http://bmj.com)
Incidence and preventability of adverse drug events among older persons in the ambulatory setting CONTEXT: Adverse drug events, especially those that may be preventable, are among the most serious concerns about medication use in older persons cared for in the ambulatory clinical setting. OBJECTIVE: To assess the incidence and preventability of adverse drug events among older persons in the ambulatory clinical setting. DESIGN, SETTING, AND PATIENTS: Cohort study of all Medicare enrollees (30 397 person-years of observation) cared for by a multispecialty group practice during a 12-month study period (July 1, 1999, through June 30, 2000), in which possible drug-related incidents occurring in the ambulatory clinical setting were detected using multiple methods, including reports from health care providers; review of hospital discharge summaries; review of emergency department notes; computergenerated signals; automated free-text review of electronic clinic notes; and review of administrative incident reports concerning medication errors. MAIN OUTCOME MEASURES: Number of adverse drug events, severity of the events (classified as significant, serious, lifethreatening, or fatal), and whether the events were preventable. RESULTS: There were 1523 identified adverse drug events, of which 27.6% (421) were considered preventable. The overall rate of adverse drug events was 50.1 per 1000 person-years, with a rate of 13.8 preventable adverse drug events per 1000 person-years. Of the adverse drug events, 578 (38.0%) were categorized as serious, life-threatening, or fatal; 244 (42.2%) of these more severe events were deemed preventable compared with 177 (18.7%) of the 945 significant adverse drug events. Errors associated with preventable adverse drug events occurred most often at the stages of prescribing (n ⫽ 246, 58.4%) and monitoring (n ⫽ 256, 60.8%), and errors involving patient adherence (n ⫽ 89, 21.1%) also were common. Cardiovascular medications (24.5%), followed by diuretics (22.1%), nonopioid analgesics (15.4%), hypoglycemics (10.9%), and anticoagulants (10.2%) were the most common medication categories associated with preventable adverse drug events. Electrolyte/renal (26.6%), gastrointestinal tract (21.1%), hemorrhagic (15.9%), metabolic/endocrine (13.8%), and neuropsychiatric (8.6%) events were the most common types of preventable adverse drug events. CONCLUSIONS: Adverse drug events are common and often preventable among older persons in the ambulatory clinical setting. More serious adverse drug events are more likely to be
OBSTETRICS & GYNECOLOGY
preventable. Prevention strategies should target the prescribing and monitoring stages of pharmaceutical care. Interventions focused on improving patient adherence with prescribed regimens and monitoring of prescribed medications also may be beneficial. Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, et al. JAMA 2003;289:1107–16. (http://jama.ama-assn.org)
The epidemiology of sepsis in the United States from 1979 through 2000* BACKGROUND: There is little demographic information available on the cases of sepsis that occur in the United States. Because sepsis remains an important condition, the authors performed an epidemiological investigation of such cases. METHODS: The authors used a nationally representative sample of the cases of sepsis that occurred in the United States from 1979 through 2000. The cases were limited to those that were cared for in nonfederal acute care hospitals. The cases were identified using appropriate ICD-9-CM codes listed on the discharge records. RESULTS: Approximately 750 million discharges occurred during the study period and 10,319,418 cases of sepsis were identified. Sepsis was more common among men than women (mean annual relative risk, 1.28, 95%CI 1.24 to 1.32), and among nonwhite persons than white (mean annual relative risk 1.90, 95%CI 1.81 to 2.00). Between 1979 and 2000 there was an annualized increase in the incidence of sepsis of 8.7% from about 83 per 100,000 population to about 240 per 100,000 population. The rate of fungal organisms increased by 207%. After 1987 the predominant pathogens were gram-positive bacteria. In-hospital mortality fell from 27.8% during the years 1979 to 1984 to 17.9% between 1995 and 2000. Mortality was highest among black males. The average length of hospital stay decreased, but the rate of discharge to nonacute care medical facilities increased. CONCLUSIONS: The incidence and the number of sepsis-related deaths are increasing in the United States, although the overall mortality rate is declining. There are racial and gender differences in the incidence of sepsis. Gram-positive bacteria and fungal organisms are increasingly common causes of sepsis. Martin GS, Mannino DM, Eaton S, Moss M. N Engl J Med 2003;348:1546 –54. (http://www.nejm.org)
Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults* BACKGROUND: The influence of excess body weight on the risk of death from cancer has not been fully characterized. METHODS: A group of more than 900,000 adults (404,576 men and 495,477 women) who were participants in the Cancer * Modified abstract.
VOL. 102, NO. 2, AUGUST 2003
Prevention Study II of the American Cancer Society were the study participants for this project. All participants were free of cancer in 1982. During the 16 years of follow up there were 57,145 deaths from cancer. The authors studied the relation in men and women between the body mass index (BMI) in 1982 and the risk of death from all cancers and from cancers at individual sites, while controlling for other risk factors in multivariate proportional-hazards models. The risk of death from cancer attributable to overweight was calculated. RESULTS: The heaviest members of the cohort (BMI of at least 40) had death rates from all cancers combined that were 52% higher for men (RR 1.52, 95%CI 1.13 to 2.05) and 62% higher for women (RR 1.62, 95%CI 1.40 to 1.87) than the rates of those of normal weight. BMI was related to higher rates of death due to cancer of the esophagus, colon, rectum, liver, gallbladder, and kidney, as well as from non-Hodgkin lymphoma and multiple myeloma. On the basis of associations observed in this study we estimate that current patterns of overweight and obesity in the United States could account for 14% of all deaths from cancer in men and 20% of those in women. CONCLUSIONS: In this study of US adults, increased body weight was found to be associated with an increased rate of death for all cancers combined, and for several specific cancer sites. Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. N Engl J Med 2003;348:1625–38. (http://www.nejm.org)
Risk of subsequent thromboembolism for patients with pre-eclampsia† BACKGROUND: More than 16% of individuals are predisposed to venous thromboembolism due to inherited thrombophilias. These disorders are also associated with an increased risk of pre-eclampsia. The authors tested the hypothesis that women with pre-eclampsia have a higher risk of subsequent venous thromboembolism. METHODS: The study used an administrative database that recorded all hospitalizations during the study period that began on April 1, 1990. All discharges with an ICD-9-CM code that indicated any degree of pre-eclampsia, eclampsia, or toxemia between the start date and January 1, 1994 were identified. Any code indicating venous thromboembolism during the study period, or after it until January 1, 1995 was identified. Multiple control groups were identified based on the ten most common obstetrical diagnoses. RESULTS: 12,849 women were identified and assigned to the pre-eclampsia group, and 284,188 in the various control groups. Venous thromboembolism was more common in the pre-eclampsia group (0.12%; 41.7 events per 100,000 person years of observation) than in any of the control groups (range 0.01% to 0.08%; 3.0 to 33.8 events per 100,000 person years of observation). After using proportional hazards modeling to control for appropriate factors, women with pre-eclampsia †
Constructed abstract.
Abstracts
411
were 2.2 times more likely (95%CI 1.3 to 3.7) to be admitted with venous thromboembolism. CONCLUSIONS: Women with pre-eclampsia have a small but significantly higher risk of subsequent venous thromboembolism compared with women diagnosed as having other common obstetrical conditions. However, the absolute risk from
412
Abstracts
pre-eclampsia was not of sufficient magnitude to warrant prophylaxis for such patients. Van Walraven C, Mamdani M, Cohn A, Katib Y, Walker M, Rodger MA. BMJ 2003;326(7393):791–2. (http://bmj.com)
OBSTETRICS & GYNECOLOGY
The following abstracts from leading journals have been selected on the basis of their importance to the practice of obstetrics and gynecology.
Outcomes of screening to prevent cancer: Analysis of cumulative incidence of cervical abnormality and modelling of cases and deaths prevented OBJECTIVE: To determine the frequency of different outcomes in women participating in cervical screening. DESIGN: Analysis of screening records from 348 419 women, and modelling of cases of cervical cancer and deaths with and without screening. SETTING: Cervical screening programme in Bristol. RESULTS: For every 10 000 women screened from 1976 to 1996, 1564 had abnormal cytology, 818 were investigated, and 543 had abnormal histology. One hundred and seventy six had persistent abnormality for two years or more. In the absence of screening 80 women would be expected to develop cancer of the cervix by 2011, of whom 25 would die. With screening 10 of these deaths would be avoided. Comparison of cumulative abnormality rates with numbers expected to develop cancer in the absence of screening suggests that at least 80% of high grade dyskaryosis and of high grade dysplasia would not progress to cancer. The lifetime risk of having abnormal cytology detected could be as high as 40% for women born since 1960. CONCLUSIONS: Screening is labour and resource intensive. It involves treatment for many women not destined to develop invasive cancer. The increased intervention rate for cervical abnormality in England is due to change in practice, not a cohort effect, and is probably the reason for the marked fall in incidence and mortality during the 1990s. For other cancers there is scope for major iatrogenic harm from screening because of invasive tests and treatments. Raffle AE, Alden B, Quinn M, Babb PJ, Brett MT. BMJ 2003; 326(7395):901. (http://bmj.com)
Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial CONTEXT: Hypertensive patients are often given a calcium antagonist to reduce cardiovascular disease risk, but the benefit compared with other drug classes is controversial. OBJECTIVE: To determine whether initial therapy with controlled-onset extended-release (COER) verapamil is equivalent to a physician’s choice of atenolol or hydrochlorothiazide in preventing cardiovascular disease.
DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized clinical trial conducted at 661 centers in 15 countries. A total of 16 602 participants diagnosed as having hypertension and who had 1 or more additional risk factors for cardiovascular disease were enrolled between September 1996 and December 1998 and followed up until December 31, 2000. After a mean of 3 years of follow-up, the sponsor closed the study before unblinding the results. INTERVENTION: Initially, 8241 participants received 180 mg of COER verapamil and 8361 received either 50 mg of atenolol or 12.5 mg of hydrochlorothiazide. Other drugs (eg, diuretic, beta-blocker, or an angiotensin-converting enzyme inhibitor) could be added in specified sequence if needed. MAIN OUTCOME MEASURES: First occurrence of stroke, myocardial infarction, or cardiovascular disease-related death. RESULTS: Systolic and diastolic blood pressure were reduced by 13.6 mm Hg and 7.8 mm Hg for participants assigned to the COER verapamil group and by 13.5 and 7.1 mm Hg for partcipants assigned to the atenolol or hydrochlorothiazide group. There were 364 primary cardiovascular disease-related events that occurred in the COER verapamil group vs 365 in atenolol or hydrochlorothiazide group (hazard ratio [HR], 1.02; 95% confidence interval [CI], 0.88-1.18; P ⫽.77). For fatal or nonfatal stroke, the HR was 1.15 (95% CI, 0.90-1.48); for fatal or nonfatal myocardial infarction, 0.82 (95% CI, 0.651.03); and for cardiovascular disease-related death, 1.09 (95% CI, 0.87-1.37). The HR was 1.05 (95% CI, 0.95-1.16) for any prespecified cardiovascular disease-related event and 1.08 (95% CI, 0.93-1.26) for all-cause mortality. Nonstroke hemorrhage was more common with participants in the COERverapamil group (n ⫽ 118) compared with the atenolol or hydrochlorothiazide group (n ⫽ 79) (HR, 1.54 [95% CI, 1.162.04]; P ⫽.003). More cardiovascular disease-related events occurred between 6 AM and noon in both the COER verapamil (99/277) and atenolol or hydrochlorothiazide (88/274) groups; HR, 1.15 (95% CI, 0.86-1.53). CONCLUSIONS: The CONVINCE trial did not demonstrate equivalence of a COER verapamil-based antihypertensive regimen compared with a regimen beginning with a diuretic or beta-blocker. When considered in the context of other trials of calcium antagonists, these data indicate that the effectiveness of calcium-channel therapy in reducing cardiovascular disease is similar but not better than diuretic or beta-blocker treatment. Black HR, Elliott WJ, Grandits G, Grambsch P, Lucente T, White WB, et al. JAMA 2003;289:2073– 82. (http://jama.ama-assn.org)
Laparoscopic adhesiolysis in patients with chronic abdominal pain: A blinded randomised controlled multi-centre trial BACKGROUND: Laparoscopic adhesiolysis for chronic abdominal pain is controversial and is not evidence based. We aimed
VOL. 102, NO. 2, AUGUST 2003 © 2003 by The American College of Obstetricians and Gynecologists. Published by Elsevier.
0029-7844/03/$30.00 doi:10.1016/S0029-7844(03)00605-7
409
to test our hypothesis that laparoscopic adhesiolysis leads to substantial pain relief and improvement in quality of life in patients with adhesions and chronic abdominal pain. METHODS: Patients had diagnostic laparoscopy for chronic abdominal pain attributed to adhesions; other causes for their pain had been excluded. If adhesions were confirmed during diagnostic laparoscopy, patients were randomly assigned either to laparoscopic adhesiolysis or no treatment. Treatment allocation was concealed from patients, and assessors were unaware of patients’ treatment and outcome. Pain was assessed for 1 year by visual analogue score (VAS) score (scale 0-100), pain change score, use of analgesics, and quality of life score. Analysis was by intention to treat. FINDINGS: Of 116 patients enrolled for diagnostic laparoscopy, 100 were randomly allocated either laparoscopic adhesiolysis (52) or no treatment (48). Both groups reported substantial pain relief and a significantly improved quality of life, but there was no difference between the groups (mean change from baseline of VAS score at 12 months: difference 3 points, p⫽0.53; 95% CI -7 to 13). INTERPRETATION: Although laparoscopic adhesiolysis relieves chronic abdominal pain, it is not more beneficial than diagnostic laparoscopy alone. Therefore, laparoscopic adhesiolysis cannot be recommended as a treatment for adhesions in patients with chronic abdominal pain. Swank DJ, Swank-Bordewijk SC, Hop WC, van Erp WF, Janssen IM, Bonjer HJ, et al. Lancet 2003;361(9365):1247–51. (http://www.thelancet.com)
Hypertensive diseases of pregnancy and risk of hypertension and stroke in later life: Results from cohort study OBJECTIVE: To examine the association between hypertensive diseases of pregnancy (gestational hypertension and preeclampsia) and the development of circulatory diseases in later life. DESIGN: Cohort study of women who had pre-eclampsia during their first singleton pregnancy. Two comparison groups were matched for age and year of delivery, one with gestational hypertension and one with no history of raised blood pressure. SETTING: Maternity services in the Grampian region of Scotland. PARTICIPANTS: Women selected from the Aberdeen maternity and neonatal databank who were resident in Aberdeen and who delivered a first, live singleton from 1951 to 1970. MAIN OUTCOME MEASURES: Current vital and cardiovascular health status ascertained through postal questionnaire survey, clinical examination, linkage to hospital discharge, and mortality data. RESULTS: There were significant positive associations between pre-eclampsia/eclampsia or gestational hypertension and later hypertension in all measures. The adjusted relative risks varied from 1.13-3.72 for gestational hypertension and 1.403.98 for pre-eclampsia or eclampsia. The adjusted incident rate ratio for death from stroke for the pre-eclampsia/eclampsia group was 3.59 (95% confidence interval 1.04 to 12.4).
410
Abstracts
CONCLUSIONS: Hypertensive diseases of pregnancy seem to be associated in later life with diseases related to hypertension. If greater awareness of this association leads to earlier diagnosis and improved management, there may be scope for reducing a proportion of the morbidity and mortality from such diseases. Wilson BJ, Watson MS, Prescott GJ, Sunderland S, Campbell DM, Hannaford P, et al. BMJ 2003;326(7394):845. (http://bmj.com)
Incidence and preventability of adverse drug events among older persons in the ambulatory setting CONTEXT: Adverse drug events, especially those that may be preventable, are among the most serious concerns about medication use in older persons cared for in the ambulatory clinical setting. OBJECTIVE: To assess the incidence and preventability of adverse drug events among older persons in the ambulatory clinical setting. DESIGN, SETTING, AND PATIENTS: Cohort study of all Medicare enrollees (30 397 person-years of observation) cared for by a multispecialty group practice during a 12-month study period (July 1, 1999, through June 30, 2000), in which possible drug-related incidents occurring in the ambulatory clinical setting were detected using multiple methods, including reports from health care providers; review of hospital discharge summaries; review of emergency department notes; computergenerated signals; automated free-text review of electronic clinic notes; and review of administrative incident reports concerning medication errors. MAIN OUTCOME MEASURES: Number of adverse drug events, severity of the events (classified as significant, serious, lifethreatening, or fatal), and whether the events were preventable. RESULTS: There were 1523 identified adverse drug events, of which 27.6% (421) were considered preventable. The overall rate of adverse drug events was 50.1 per 1000 person-years, with a rate of 13.8 preventable adverse drug events per 1000 person-years. Of the adverse drug events, 578 (38.0%) were categorized as serious, life-threatening, or fatal; 244 (42.2%) of these more severe events were deemed preventable compared with 177 (18.7%) of the 945 significant adverse drug events. Errors associated with preventable adverse drug events occurred most often at the stages of prescribing (n ⫽ 246, 58.4%) and monitoring (n ⫽ 256, 60.8%), and errors involving patient adherence (n ⫽ 89, 21.1%) also were common. Cardiovascular medications (24.5%), followed by diuretics (22.1%), nonopioid analgesics (15.4%), hypoglycemics (10.9%), and anticoagulants (10.2%) were the most common medication categories associated with preventable adverse drug events. Electrolyte/renal (26.6%), gastrointestinal tract (21.1%), hemorrhagic (15.9%), metabolic/endocrine (13.8%), and neuropsychiatric (8.6%) events were the most common types of preventable adverse drug events. CONCLUSIONS: Adverse drug events are common and often preventable among older persons in the ambulatory clinical setting. More serious adverse drug events are more likely to be
OBSTETRICS & GYNECOLOGY
preventable. Prevention strategies should target the prescribing and monitoring stages of pharmaceutical care. Interventions focused on improving patient adherence with prescribed regimens and monitoring of prescribed medications also may be beneficial. Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, et al. JAMA 2003;289:1107–16. (http://jama.ama-assn.org)
The epidemiology of sepsis in the United States from 1979 through 2000* BACKGROUND: There is little demographic information available on the cases of sepsis that occur in the United States. Because sepsis remains an important condition, the authors performed an epidemiological investigation of such cases. METHODS: The authors used a nationally representative sample of the cases of sepsis that occurred in the United States from 1979 through 2000. The cases were limited to those that were cared for in nonfederal acute care hospitals. The cases were identified using appropriate ICD-9-CM codes listed on the discharge records. RESULTS: Approximately 750 million discharges occurred during the study period and 10,319,418 cases of sepsis were identified. Sepsis was more common among men than women (mean annual relative risk, 1.28, 95%CI 1.24 to 1.32), and among nonwhite persons than white (mean annual relative risk 1.90, 95%CI 1.81 to 2.00). Between 1979 and 2000 there was an annualized increase in the incidence of sepsis of 8.7% from about 83 per 100,000 population to about 240 per 100,000 population. The rate of fungal organisms increased by 207%. After 1987 the predominant pathogens were gram-positive bacteria. In-hospital mortality fell from 27.8% during the years 1979 to 1984 to 17.9% between 1995 and 2000. Mortality was highest among black males. The average length of hospital stay decreased, but the rate of discharge to nonacute care medical facilities increased. CONCLUSIONS: The incidence and the number of sepsis-related deaths are increasing in the United States, although the overall mortality rate is declining. There are racial and gender differences in the incidence of sepsis. Gram-positive bacteria and fungal organisms are increasingly common causes of sepsis. Martin GS, Mannino DM, Eaton S, Moss M. N Engl J Med 2003;348:1546 –54. (http://www.nejm.org)
Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults* BACKGROUND: The influence of excess body weight on the risk of death from cancer has not been fully characterized. METHODS: A group of more than 900,000 adults (404,576 men and 495,477 women) who were participants in the Cancer * Modified abstract.
VOL. 102, NO. 2, AUGUST 2003
Prevention Study II of the American Cancer Society were the study participants for this project. All participants were free of cancer in 1982. During the 16 years of follow up there were 57,145 deaths from cancer. The authors studied the relation in men and women between the body mass index (BMI) in 1982 and the risk of death from all cancers and from cancers at individual sites, while controlling for other risk factors in multivariate proportional-hazards models. The risk of death from cancer attributable to overweight was calculated. RESULTS: The heaviest members of the cohort (BMI of at least 40) had death rates from all cancers combined that were 52% higher for men (RR 1.52, 95%CI 1.13 to 2.05) and 62% higher for women (RR 1.62, 95%CI 1.40 to 1.87) than the rates of those of normal weight. BMI was related to higher rates of death due to cancer of the esophagus, colon, rectum, liver, gallbladder, and kidney, as well as from non-Hodgkin lymphoma and multiple myeloma. On the basis of associations observed in this study we estimate that current patterns of overweight and obesity in the United States could account for 14% of all deaths from cancer in men and 20% of those in women. CONCLUSIONS: In this study of US adults, increased body weight was found to be associated with an increased rate of death for all cancers combined, and for several specific cancer sites. Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. N Engl J Med 2003;348:1625–38. (http://www.nejm.org)
Risk of subsequent thromboembolism for patients with pre-eclampsia† BACKGROUND: More than 16% of individuals are predisposed to venous thromboembolism due to inherited thrombophilias. These disorders are also associated with an increased risk of pre-eclampsia. The authors tested the hypothesis that women with pre-eclampsia have a higher risk of subsequent venous thromboembolism. METHODS: The study used an administrative database that recorded all hospitalizations during the study period that began on April 1, 1990. All discharges with an ICD-9-CM code that indicated any degree of pre-eclampsia, eclampsia, or toxemia between the start date and January 1, 1994 were identified. Any code indicating venous thromboembolism during the study period, or after it until January 1, 1995 was identified. Multiple control groups were identified based on the ten most common obstetrical diagnoses. RESULTS: 12,849 women were identified and assigned to the pre-eclampsia group, and 284,188 in the various control groups. Venous thromboembolism was more common in the pre-eclampsia group (0.12%; 41.7 events per 100,000 person years of observation) than in any of the control groups (range 0.01% to 0.08%; 3.0 to 33.8 events per 100,000 person years of observation). After using proportional hazards modeling to control for appropriate factors, women with pre-eclampsia †
Constructed abstract.
Abstracts
411
were 2.2 times more likely (95%CI 1.3 to 3.7) to be admitted with venous thromboembolism. CONCLUSIONS: Women with pre-eclampsia have a small but significantly higher risk of subsequent venous thromboembolism compared with women diagnosed as having other common obstetrical conditions. However, the absolute risk from
412
Abstracts
pre-eclampsia was not of sufficient magnitude to warrant prophylaxis for such patients. Van Walraven C, Mamdani M, Cohn A, Katib Y, Walker M, Rodger MA. BMJ 2003;326(7393):791–2. (http://bmj.com)
OBSTETRICS & GYNECOLOGY