Carol Conell

Complications of Colonoscopy in an Integrated Health Care Delivery System

Context Data on the frequency of colonoscopy complications from population-based samples are lacking. Contribution The authors searched electronic health records at Kaiser-Permanente of Northern California for patients who died or who had complications due to colonoscopy within 30 days of the procedure. Almost all procedures were diagnostic or for surveillance of previous abnormal findings. Of16318 eligible procedures, 82 involved serious complications (5 in 1000 procedures). Of the 82 complications, 95% followed biopsy or removal of polyps, and 62% of the polyps removed were smaller than 10 mm. The perforation rate was 1 in 1000 procedures. One death was related to colonoscopy. Cautions Less than 1% of procedures studied were screening colonoscopies, so these complication rates might not apply to screening examinations. The Editors Colonoscopy is the final step in colorectal cancer screening, regardless of the initial test chosen, and is recommended for primary colorectal cancer screening in average- risk persons (14). Colorectal cancer screening targets apparently healthy people; therefore, the magnitude of the risk and severity of the harms from screening are important issues to consider when selecting a screening strategy (5). Described complications of colonoscopy include colonic perforation, postbiopsy and postpolypectomy bleeding, and postpolypectomy syndrome (a transmural colonic burn, marked by localized abdominal pain without evidence of frank perforation) (6). Diverticulitis, which is caused by a microscopic perforation of the colon, can also theoretically be caused by colonoscopy in persons with preexisting diverticulosis. Most estimates of colonoscopy complications come from referral centers (712) or closely monitored clinical trials (13), limiting the generalizability of the results to community practice. In a large series by a group of ambulatory endoscopy centers (14), endoscopists self-reported complications, possibly underestimating them (15). In this study, researchers were unable to evaluate postpolypectomy bleeding. Postpolypectomy bleeding is particularly difficult to assess in studies because its occurrence is often delayed. The U.S. Preventive Services Task Force (16), in a recent evidence review of colonoscopy complications, concluded that postpolypectomy bleeding was reported in relatively few studies and delayed bleeding was not reported at all. Studies using administrative databases typically lack access to detailed records, including indications, depth of insertion, and whether or how polyps are removed (17). For the present study, we relied on the automated data of Kaiser Permanente, Northern California (KPNC), an integrated health care delivery system. Colonoscopy was most often used to follow-up other tests, such as fecal occult blood tests, flexible sigmoidoscopy, or barium enema, or to conduct surveillance in persons with a personal or family history of colorectal cancer or colorectal adenoma. Few colonoscopies were performed for primary screening. We identified patients undergoing colonoscopy and followed them for 30 days after the procedure for hospitalization for procedure-related complications. For this analysis, we defined any procedure-related complication that led to hospitalization as a serious complication. Methods We used KPNC electronic medical records to select patients who had undergone colonoscopies between 1 January 1994 and 16 July 2002. This was an observational study, conducted in medical centers throughout the KP health care system, evaluating practice patterns as they existed at the time the included colonoscopies were performed by the endoscopists in the study. Electronic records were reviewed to identify immediate complications, outpatient visits, or hospital admission within 30 days of colonoscopy. Colonoscopies were included in the analysis if they were performed for patients 40 years of age or older who were undergoing coloscopy because of a family history of colorectal cancer or adenomatous polyp, as a follow-up to a positive screening test (that is, polyp or cancer at sigmoidoscopy, positive results on a fecal occult blood test, or abnormal barium enema radiography), for surveillance because of a previously detected adenomatous polyp or colorectal cancer, or for primary screening. Colonoscopies were not included if the procedure was being performed to diagnose symptoms (for example, diarrhea, abdominal pain, gastrointestinal bleeding, history of rectal bleeding, or anemia) or if patients had outpatient visits 6 months before the procedure for abdominal pain, anemia, diarrhea, or constipation. A total of 35945 procedures performed at KPNC between 1 January 1994 and 16 July 2002 were identified by using 2 electronic KPNC endoscopy databases. The first database, the Colorectal Cancer Prevention (CoCaP) program database, contains detailed information from 1994 to 1996 on sigmoidoscopies, follow-up colonoscopies, and the results of pathologic testing. Information available in the CoCaP database includes depth of insertion; size, number, and treatment of polyps; limitations of the procedure; and identity of the examiner. The second database, the EndoLog Pro database, includes colonoscopy reports from 1995 to 2002 from 5 KP facilities. The database contains information on number of polyps found and their treatment, depth of insertion, quality of bowel preparation, identity of the examiner, and any immediate complications. Some patients underwent more than 1 colonoscopy during the study period. If a colonoscopy was incomplete because of poor bowel preparation, and a second colonoscopy was performed within 3 months, only the second colonoscopy was included in the cohort. If a patient required a second colonoscopy to complete removal of a polyp, only the first colonoscopy was included in the cohort. Patients requiring frequent surveillance may have been screened more than once during the 7-year study period; colonoscopies were included for these patients if the interval between the colonoscopies was greater than 6 months. Identification of Eligible Cases Of the 35945 procedures, 4646 were excluded because patients were younger than 40 years of age; 9499 were excluded because the procedures were performed for excluded indications or for symptoms; and 2411 were excluded because of poor preparation (with a second examination rescheduled in 90 days), interval since previous procedure was less than 6 months, previous colon surgery, or because the procedure was for follow-up removal of residual polyps or for marking polyp site for surgery. Inpatient procedures (n= 125) and procedures for KPNC nonmembers (n= 57) were excluded. Procedures were also excluded if patients had inpatient or outpatient visits for lower gastrointestinal bleeding, abdominal pain, anemia, diarrhea, or constipation 6 months before the procedures (n= 2689). A total of 16318 procedures were included in the analysis. Identification of Possible Complications A 2-step procedure was used to identify serious complications. First, we analyzed KP electronic databases for evidence of patients being admitted to the hospital (a KPNC or nonprogram hospital) within 30 days of colonoscopy. We focused on admissions that could be associated with colonoscopy complications or complications of procedural sedation, including colonic perforation (International Classifications of Diseases, 9th revision, [ICD-9] codes 569.83 and 998.2]; lower gastrointestinal bleeding (ICD-9 558.9, 578.1, 995.2, 995.89, and 998.1 to 998.13); anemia, not explained by preexisting conditions (ICD-9 280.0 and 285.0 to 285.9); diverticulitis (ICD-9 562.11); colitis, not present during initial endoscopy (ICD-9 556 to 556.9); aspiration pneumonia (ICD-9 507); pneumonia, organism unspecified (ICD-9 486); infection (ICD-9 780.6, 790.7, and 424.9 to 424.99); abdominal pain (ICD-9 789.0 to 789.09); complications of procedure (E872, E872.8, E872.9, E879, E879.8, and E879.9); complications secondary to anesthesia (ICD-9 995.4, 997.1, and 997.3); myocardial infarction (ICD-9 410 to 410.92 and 414); and stroke (ICD-9 436). Deaths within 30 days of colonoscopy were identified through linkage with the National Death Index. After possible cases were identified from electronic records, medical records analysts at KPNC reviewed the hardcopy medical records, computerized medical records, and laboratory records of 183 patients by using chart review forms. Analysts made photocopies of histories and physicals, discharge summaries, colonoscopy reports, operative notes, and pathology reports, and these were used to make decisions. Two physicians reviewed the photocopied records to determine whether the hospitalization or death was related to colonoscopy. Clinical judgment was used in making these decisions through a collaborative process, and decisions were made by mutual agreement. A third physician adjudicated the 1 case in which there were ongoing questions. A subsample of 44 records was reviewed by both physicians independently. The -statistic for this statistical analysis was 0.71 (CI, 0.52 to 0.89). Statistical Analysis Individual complication measures were created to reflect the incidence of serious complications in the first 30 days after colonoscopy for the following: 1) colonic perforation; 2) the postpolypectomy syndrome; 3) bleeding requiring overnight hospitalization, overall and separately for patients with or without surgery or transfusion; 4) diverticulitis requiring overnight hospitalization, overall and separately for patients with or without surgery; and 5) any other hospitalization within 30 days that was likely to have been caused or exacerbated by the procedure. Two aggregate measures were used. The first was for all of the above categories combined and the second for the most serious complications, including perforation, bleeding with transfusion, and diverticulitis requiring surgery. For each complication measure, we calculated the inc

Statin Use During Ischemic Stroke Hospitalization Is Strongly Associated With Improved Poststroke Survival

Background and Purpose— Statins reduce infarct size in animal models of stroke and have been hypothesized to improve clinical outcomes after ischemic stroke. We examined the relationship between statin use before and during stroke hospitalization and poststroke survival. Methods— We analyzed records from 12 689 patients admitted with ischemic stroke to any of 17 hospitals in a large integrated healthcare delivery system between January 2000 and December 2007. We used multivariable survival analysis and grouped-treatment analysis, an instrumental variable method that uses treatment differences between facilities to avoid individual patient-level confounding. Results— Statin use before ischemic stroke hospitalization was associated with improved survival (hazard ratio, 0.85; 95% CI, 0.79–0.93; P<0.001), and use before and during hospitalization was associated with better rates of survival (hazard ratio, 0.59; 95% CI, 0.53–0.65; P<0.001). Patients taking a statin before their stroke who underwent statin withdrawal in the hospital had a substantially greater risk of death (hazard ratio, 2.5; 95% CI, 2.1–2.9; P<0.001). The benefit was greater for high-dose (>60 mg/day) statin use (hazard ratio, 0.43; 95% CI, 0.34–0.53; P<0.001) than for lower dose (<60 mg/day) statin use (hazard ratio, 0.60; 95% CI, 0.54–0.67; P<0.001; test for trend P<0.001), and earlier treatment in-hospital further improved survival. Grouped-treatment analysis showed that the association between statin use and survival cannot be explained by patient-level confounding. Conclusions— Statin use early in stroke hospitalization is strongly associated with improved poststroke survival, and statin withdrawal in the hospital, even for a brief period, is associated with worsened survival.

Alcohol drinking patterns and medical care use in an HMO setting.

The objective of this study was to examine the association of medical care use (outpatient visits and hospitalization) with alcohol drinking patterns in a large health maintenance organization (HMO). Data were gathered from a random sample of 10,292 adult respondents through a telephone survey conducted between June 1994 and February 1996. Findings indicate that current non-drinkers with no past history of drinking had higher rates of outpatient visits and hospitalizations than current drinkers. Among current drinkers, medical care use declined slightly as drinking levels increased. Among nondrinkers, those with a drinking history exhibited significantly higher use of outpatient visits and hospital care than nondrinkers with no drinking history and current drinkers. Controlling for demographic and socioeconomic factors, health status, and common medical conditions in multivariate analyses suggests that nondrinkers with a drinking history use more services because they are sicker than other nondrinkers or current drinkers.

Effect of Statin Use During Hospitalization for Intracerebral Hemorrhage on Mortality and Discharge Disposition

IMPORTANCE Statin use during hospitalization is associated with improved survival and a better discharge disposition among patients with ischemic stroke. It is unclear whether inpatient statin use has a similar effect among patients with intracerebral hemorrhage (ICH). OBJECTIVE To determine whether inpatient statin use in ICH is associated with improved outcomes and whether the cessation of statin use is associated with worsened outcomes. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study of 3481 patients with ICH admitted to any of 20 hospitals in a large integrated health care delivery system over a 10-year period. Detailed electronic medical and pharmacy records were analyzed to explore the association between inpatient statin use and outcomes. MAIN OUTCOMES AND MEASURES The primary outcome measures were survival to 30 days after ICH and discharge to home or inpatient rehabilitation facility. We used multivariable logistic regression, controlling for demographics, comorbidities, initial severity, and code status. In addition, we used instrumental variable modeling to control for confounding by unmeasured covariates at the individual patient level. RESULTS Among patients hospitalized for ICH, inpatient statin users were more likely than nonusers to be alive 30 days after ICH (odds ratio [OR], 4.25 [95% CI, 3.46-5.23]; P < .001) and were more likely than nonusers to be discharged to their home or an acute rehabilitation facility (OR, 2.57 [95% CI, 2.16-3.06]; P < .001). Patients whose statin therapy was discontinued were less likely than statin users to survive to 30 days (OR, 0.16 [95% CI, 0.12-0.21]; P < .001) and were less likely than statin users to be discharged to their home or an acute rehabilitation facility (OR, 0.26 [95% CI, 0.20-0.35]; P < .001). Instrumental variable models of local treatment environment (to control for confounding by unmeasured covariates) confirmed that a higher probability of statin therapy was associated with a higher probability of 30-day survival (with an increase in probability of 0.15 [95% CI, 0.04-0.25]; P = .01) and a better chance of being discharged to home or an acute rehabilitation facility (with an increase in probability of 0.13 [95% CI, 0.02-0.24]; P = .02). CONCLUSIONS AND RELEVANCE Inpatient statin use is associated with improved outcomes after ICH, and the cessation of statin use is associated with worsened outcomes after ICH. Given the association between statin cessation and substantially worsened outcomes, the risk-benefit balance of discontinuing statin therapy in the acute setting of ICH should be carefully considered.

Rapid Warfarin Reversal in the Setting of Intracranial Hemorrhage: A Comparison of Plasma, Recombinant Activated Factor VII, and Prothrombin Complex Concentrate

OBJECTIVE To compare the safety and effectiveness of three methods of reversing coagulopathic effects of warfarin in patients with potentially life-threatening intracranial hemorrhage. METHODS A retrospective electronic medical record review of 63 patients with warfarin-related intracranial hemorrhage between 2007 and 2010 in an integrated health care delivery system was conducted. The three methods of rapid warfarin reversal were fresh-frozen plasma (FFP), activated factor VII (FVIIa; NovoSevenRT [Novo Nordisk, Bagsværd, Denmark]), and prothrombin complex concentrate (PCC; BebulinVH [Baxter, Westlake Village, California, USA], ProfilnineSD [Grifols, North Carolina, USA]), each used adjunctively with vitamin K (Vit K, phytonadione). We determined times from reversal agent order to laboratory evidence of warfarin reversal (international normalized ratio [INR]) in the first 48 hours and compared INR rebound rates and complications in the first 48 hours. RESULTS Reversal with FFP took more than twice as long compared with FVIIa or PCC. To reach an INR of 1.3, mean (±SD) reversal times were 1933 ± 905 minutes for FFP, 784 ± 926 minutes for FVIIa, and 980 ± 1021 minutes for PCC (P < 0.001; P < 0.01 between FFP and FVIIa, P < 0.05 between FFP and PCC). INR rebound occurred in 0 of 31 patients for FFP, 4 of 8 for FVIIa, and 0 of 7 for PCC (P = 0.001). Complications were uncommon. FVIIa was 15 and 3.5 times as expensive as FFP and PCC, respectively. CONCLUSION As an adjunct to Vit K for rapid warfarin reversal, FVIIa and PCC appear more effective than FFP. Either FVIIa or PCC are reasonable options for reversal, but FVIIa is considerably more expensive and may have greater risk of INR rebound.

Inpatient statin use predicts improved ischemic stroke discharge disposition

Objective: To determine whether statin use is associated with improved discharge disposition after ischemic stroke. Methods: We used generalized ordinal logistic regression to analyze discharge disposition among 12,689 patients with ischemic stroke over a 7-year period at 17 hospitals in an integrated care delivery system. We also analyzed treatment patterns by hospital to control for the possibility of confounding at the individual patient level. Results: Statin users before and during stroke hospitalization were more likely to have a good discharge outcome (odds ratio [OR] for discharge to home = 1.38, 95% confidence interval [CI] 1.25–1.52, p < 0.001; OR for discharge to home or institution = 2.08, 95% CI 1.72–2.51, p < 0.001). Patients who underwent statin withdrawal were less likely to have a good discharge outcome (OR for discharge to home = 0.77, 95% CI 0.63–0.94, p = 0.012; OR for discharge to home or institution = 0.43, 95% CI 0.33–0.55, p < 0.001). In grouped-treatment analysis, an instrumental variable method using treatment patterns by hospital, higher probability of inpatient statin use predicted a higher likelihood of discharge to home (OR = 2.56, 95% CI 1.71–3.85, p < 0.001). In last prior treatment analysis, a novel instrumental variable method, patients with a higher probability of statin use were more likely to have a good discharge outcome (OR for each better level of ordinal discharge outcome = 1.19, 95% CI 1.09–1.30, p = 0.001). Conclusions: Statin use is strongly associated with improved discharge disposition after ischemic stroke.

Prediction of intracerebral haemorrhage expansion with clinical, laboratory, pharmacologic, and noncontrast radiographic variables.

Background Hematoma expansion confers excess mortality in intracerebral haemorrhage, and is potentially preventable if at-risk patients can be identified. Contrast extravasation on initial computed tomographic angiography strongly predicts hematoma expansion but is not very sensitive, and most centers have not yet integrated computed tomographic angiography into acute intracerebral haemorrhage management. We therefore asked whether other presentation variables can predict hematoma expansion. Methods We searched the electronic medical records of a large integrated healthcare delivery system to identify patients with a hospitalization discharge diagnosis of intracerebral haemorrhage between the years 2008 and 2010. Hematoma expansion was defined as radiographic increase by 1/3 or by 12·5 ml within 48 h of presentation. Pre-specified patient demographic and clinical presentation variables were extracted. Stepwise multivariable logistic regression was performed to model hematoma expansion. Because some patients may have died from hematoma expansion without a second head computed tomography, we constructed a separate model including patients that died without a second head computed tomography in 48 h, hematoma expansion or death. Results Ninety-one of 257 patients (35%) had hematoma expansion. Antithrombotic use (odds ratio = 1·9, P = 0·04) and initial mNIHSS (modified National Institutes of Health Stroke Scale; odds ratio = 1·06, P = 0·001) were significant predictors in the hematoma expansion model (area under the Receiver–Operator Characteristics curve, AUROC = 0·6712, pseudo-r2 = 0·0641). 163 of 343 patients (48%) had hematoma expansion or death. Age (odds ratio = 1·02, P = 0·02), initial mNIHSS (odds ratio = 1·07, P < 0·001), and initial hematoma volume (odds ratio = 1·01, P = 0·03) were significant predictors of hematoma expansion or death (AUROC = 0·7579, pseudo-r2 = 0·1722). Conclusion Clinical and noncontrast radiographic variables only weakly predict hematoma expansion. Examination of other indicators, such as computed tomographic angiography contrast extravasation (the ‘spot sign’), may prove more valuable in acute intracerebral haemorrhage care.

Osteoporosis risk and management in BRCA1 and BRCA2 carriers who undergo risk-reducing salpingo-oophorectomy

OBJECTIVE Characterize current management of osteoporosis risk in BRCA carriers following risk-reducing salpingo-oophorectomy (RRSO). METHODS Women with a BRCA1 or BRCA2 mutation who underwent RRSO were identified from a community-based health system in Northern California from 1995 to 2012. Retrospective chart review using the electronic medical record was performed. The primary outcome was the number of women who had a dual-energy X-ray absorptiometry scan post-RRSO. Secondary outcomes included new diagnoses of osteopenia, osteoporosis, and fracture. Information on the following risk factors was also recorded: calcium and vitamin D use, history of breast cancer, chemotherapy, use of aromatase inhibitors, and use of hormone replacement therapy. RESULTS Two hundred and twenty five women tested positive for a BRCA1 or BRCA2 mutation and underwent RRSO. Median follow-up was 41 months from testing. Ninety-nine (44.0%) had at least one DXA scan following testing. The median time from RRSO to a diagnosis of bone disease was 29 months (range 1-170). Seventy-two percent had only one DXA scan (range 1-7) following testing. Thirty-two percent had normal results, 55.6% had osteopenia and 12.1% had osteoporosis. Four percent of women had an atraumatic fracture after surgery. Age, breast cancer history, prior chemotherapy, and tamoxifen or aromatase inhibitor (AI) use were not associated with having osteoporosis or osteopenia. CONCLUSIONS Women with BRCA mutations who undergo RRSO have many risk factors for bone loss. The majority of these women are not being screened for bone loss. A clear guideline for screening needs to be established to improve detection of post-RRSO bone disease.

Statin Adherence Is Associated With Reduced Recurrent Stroke Risk in Patients With or Without Atrial Fibrillation

Background and Purpose— Outpatient statin use reduces the risk of recurrent ischemic stroke among patients with stroke of atherothrombotic cause. It is not known whether statins have similar effects in ischemic stroke caused by atrial fibrillation (AFib). Methods— We studied outpatient statin adherence, measured by percentage of days covered, and the risk of recurrent ischemic stroke in patients with or without AFib in a 21-hospital integrated healthcare delivery system. Results— Among 6116 patients with ischemic stroke discharged on a statin over a 5-year period, 1446 (23.6%) had a diagnosis of AFib at discharge. The mean statin adherence rate (percentage of days covered) was 85, and higher levels of percentage of days covered correlated with greater degrees of low-density lipoprotein suppression. In multivariable survival models of recurrent ischemic stroke over 3 years, after controlling for age, sex, race/ethnicity, medical comorbidities, and hospital center, higher statin adherence predicted reduced stroke risk both in patients without AFib (hazard ratio, 0.78; 95% confidence interval, 0.63–0.97) and in patients with AFib (hazard ratio, 0.59; 95% confidence interval, 0.43–0.81). This association was robust to adjustment for the time in the therapeutic range for international normalized ratio among AFib subjects taking warfarin (hazard ratio, 0.61; 95% confidence interval, 0.41–0.89). Conclusions— The relationship between statin adherence and reduced recurrent stroke risk is as strong among patients with AFib as it is among patients without AFib, suggesting that AFib status should not be a reason to exclude patients from secondary stroke prevention with a statin.

Venous thromboembolism following minimally invasive surgery among women with endometrial cancer

OBJECTIVE To determine the rate of venous thromboembolism (VTE) among women undergoing minimally invasive surgery (MIS) for endometrial cancer. METHODS Women undergoing robotic or laparoscopic hysterectomy for endometrial carcinoma or complex hyperplasia with atypia were identified between January 2009 and 2014 in a community based health care system. Patient data including age, race, cancer stage, grade, procedure type, length of hospital stay, use of prophylaxis, and diagnosis of VTE were collected retrospectively. The primary outcome was the rate of VTE within 30days following surgery. Fischers exact tests were performed to evaluate factors associated with VTE. RESULTS During the study period, 1433 patients underwent MIS for endometrial cancer, with 20 excluded due to known thrombophilia, VTE history, or long-term anticoagulation. A total of 1413 patients were included (739 robotic and 674 laparoscopic cases). All women received mechanical prophylaxis per hospital policy and 61% had additional pharmacologic prophylaxis. The rate of VTE was 0.35% (5/1413), which did not differ among those who received pharmacologic compared to mechanical prophylaxis (0.23% [2/865] versus 0.55% [3/548] respectively, p=0.38). No factors were associated with increased risk of VTE due to the low event rate. CONCLUSION VTE in patients undergoing MIS for endometrial cancer was very low irrespective of the mode of prophylaxis received in this large cohort. National guidelines for VTE prophylaxis need to differentiate the low risk associated with MIS surgery from the risk associated with laparotomy for endometrial cancer. We recommend mechanical prophylaxis is sufficient for these women undergoing MIS.