Janet Grubber - Academia.edu (original) (raw)
Papers by Janet Grubber
Research investigators and clinicians are often interested in producing personalized risk graphs ... more Research investigators and clinicians are often interested in producing personalized risk graphs for research participants or patients. We used the GKPI procedure in SAS version 9.2 to produce batches of risk graphs for a randomized trial of an intervention to communicate participants’ individual risks for developing type 2 diabetes based on demographic, clinical, and genetic risk factors. We pilot-tested a variety of potential graphs with 35 participants to determine, based on participant feedback, which graphs were most easily understood and most clearly communicated risk. Graphs created by PROC GKPI can only be produced by hard coding the data values within the procedure rather than by passing the values to the procedure through the “DATA=Data Set Name” option. We present a macro and CALL EXECUTE code to demonstrate a method for producing batches of graphs without having to hard code the data values within the GKPI procedure. This paper presents the final versions of these risk g...
When you are creating “Table 1 – Demographics” type tables for journal articles or presentations,... more When you are creating “Table 1 – Demographics” type tables for journal articles or presentations, do you find it tedious to manually type or cut and paste output from SAS PROC FREQ or PROC UNIVARIATE into Microsoft Word documents? Do you find yourself spending a lot of time double-checking to make sure you didn’t make any typos during that process? Do you feel like you’re wasting precious time when you have to go back and manually redo a table because you discover that you should have presented your data stratified by an additional variable (such as race) rather than just your overall data? Fear not…there is a way to cut down on your effort and the need to check for typos with a little bit of up-front effort in SAS. This paper describes methods for automating the production of demographic-type tables by using PROC TEMPLATE, PROC FORMAT, PROC TABULATE, LABEL statements, and ODS RTF in SAS. In addition, this paper describes how the following special features can be used in SAS to make...
JAMA internal medicine, Jan 30, 2017
The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose... more The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose computed tomography for current and former heavy smokers aged 55 to 80 years. There is little published experience regarding implementing this recommendation in clinical practice. To describe organizational- and patient-level experiences with implementing an LCS program in selected Veterans Health Administration (VHA) hospitals and to estimate the number of VHA patients who may be candidates for LCS. This clinical demonstration project was conducted at 8 academic VHA hospitals among 93 033 primary care patients who were assessed on screening criteria; 2106 patients underwent LCS between July 1, 2013, and June 30, 2015. Implementation Guide and support, full-time LCS coordinators, electronic tools, tracking database, patient education materials, and radiologic and nodule follow-up guidelines. Description of implementation processes; percentages of patients who agreed to undergo LCS, had ...
Obesity Science & Practice, 2016
A weight loss maintenance trial involving weight loss prior to randomization is challenging to im... more A weight loss maintenance trial involving weight loss prior to randomization is challenging to implement due to the potential for dropout and insufficient weight loss. We examined rates and correlates of non-initiation, dropout, and insufficient weight loss during a weight loss maintenance trial. Methods The MAINTAIN trial involved a 16-week weight loss program followed by randomization among participants losing at least 4 kg. Psychosocial measures were administered during a screening visit. Weight was obtained at the first group session and 16 weeks later to determine eligibility for randomization. Results Of 573 patients who screened as eligible, 69 failed to initiate the weight loss program. In adjusted analyses, failure to initiate was associated with lower age, lack of a support person, and less encouragement for making dietary changes. Among participants who initiated, 200 dropped out, 82 lost insufficient weight, and 222 lost sufficient weight for randomization. Compared to losing sufficient weight, dropping out was associated with younger age and tobacco use, whereas losing insufficient weight was associated with non-White race and controlled motivation for physical activity. Conclusions Studies should be conducted to evaluate strategies to maximize recruitment and retention of subgroups that are less likely to initiate and be retained in weight loss maintenance trials.
Journal of the National Medical Association, 2009
Background-Individual variation in circulating insulin-like growth factor-I (IGF1) and its major ... more Background-Individual variation in circulating insulin-like growth factor-I (IGF1) and its major binding protein, insulin-like growth factor binding protein-3 (IGFBP3) have been etiologically linked to several chronic diseases, including some cancers. Factors associated with variation in circulating levels of these peptide hormones remain unclear. Methods-Multiple linear regression models were used to determine the extent to which sociodemographic characteristics, lifestyle factors, personal and family history of chronic disease, and common genetic variants, the (CA) n repeat polymorphism in the IGF1 promoter and the IGFBP3-202 A/C polymorphism (rs2854744) predict variation in IGF1 or IGFBP3 serum levels in 33 otherwise healthy African American and 37 white males recruited from Durham Veterans Administration Medical Center. Results-Predictors of serum IGF1, IGFBP3 and the IGF1:IGFBP3 molar ratio varied by race. In African Americans, 17% and 28% of the variation in serum IGF1 and the IGF1:IGFBP3 molar ratio, respectively, was explained by cigarette smoking and carrying the IGF1 (CA) 19 repeat allele, respectively. Not carrying at least one IGF1 (CA) 19 repeat allele and a high BMI explained 8%
Sleep, Jan 12, 2015
Sleep disorders are often unrecognized and/or poorly managed in primary care. Objective: To test ... more Sleep disorders are often unrecognized and/or poorly managed in primary care. Objective: To test a collaborative care model for interfacing sleep specialists with primary care providers to enhance patients' sleep disorders management. A prospective, randomized, parallel group, clinical intervention trial with patients assigned to an intervention (INT) or waiting-list, usual primary care (UPC) group. One university-affiliated Veterans Affairs (VA) Medical Center. A total of 137 adult (29 women) VA outpatients with sleep complaints. A one-time sleep specialty consultation with diagnostic feedback and treatment recommendations provided to the patient and the patient's primary care provider. Provider outcomes included rates of adherence to recommended diagnostic procedures and sleep-focused interventions. Patient outcomes included measures taken from sleep diaries and actigraphy; Pittsburgh Sleep Quality Index (PSQI) scores; and self-report measures of sleepiness, fatigue, mood,...
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, Jan 19, 2015
Regular screening with colonoscopy lowers colorectal cancer incidence and mortality. We aimed to ... more Regular screening with colonoscopy lowers colorectal cancer incidence and mortality. We aimed to determine patterns of repeat and surveillance colonoscopy and identify factors associated with over- and underuse of colonoscopy. We analyzed data from participants in a previous Veterans Health Administration (VHA) study who underwent outpatient colonoscopy at 25 VHA facilities between October 2007 and September 2008 (n=1455). The proportion of patients who received a follow-up colonoscopy was calculated for 3 risk groups, defined based on the index colonoscopy: no adenoma, low-risk adenoma, or high-risk adenoma. Colonoscopy was overused (used more frequently than intervals recommended by guidelines) by 16% of patients with no adenomas, 26% with low-risk adenomas, and 29% with high-risk adenomas. Most patients with high-risk adenomas (54%) underwent colonoscopy after the recommended interval or did not undergo colonoscopy. Patients who received a follow-up recommendation that was discor...
Bone, 2015
With ethical requirements to the enrollment of lower risk subjects, osteoporosis trials are under... more With ethical requirements to the enrollment of lower risk subjects, osteoporosis trials are underpowered to detect reduction in hip fractures. Different skeletal sites have different levels of fracture risk and response to treatment. We sought to identify fracture sites which cluster with hip fracture at higher than expected frequency; if these sites respond to treatment similarly, then a composite fracture endpoint could provide a better estimate of hip fracture reduction. Methods: Cohort study using Veterans Affairs and Medicare administrative data. Male Veterans (n=5,036,536) aged 50-99 years receiving VA primary care between1999-2009 were included. Fractures were ascertained using ICD9 and CPT codes and classified by skeletal site. Pearson correlation coefficients, logistic regression and kappa statistics, were used to describe the correlation between each fracture type and hip fracture within individuals, without regards to the timing of the events. Results: 595,579 (11.8%) men suffered 1 or more fractures and 179,597 (3.6%) suffered 2 or more fractures during the time under study. Of those with one or more fractures, rib was the most common site (29%), followed by spine (22%), hip (21%) and femur (20%). The fracture types most highly correlated with hip fracture were pelvic/acetabular (Pearson correlation coefficient 0.25, p<0.0001), femur (0.15, p<0.0001), and shoulder (0.11, p<0.0001). Conclusions: Pelvic, acetabular, femur, and shoulder fractures cluster with hip fractures within individuals at greater than expected frequency. If we observe similar treatment risk reductions within that cluster, subsequent trials could consider use of a composite endpoint to better estimate hip fracture risk.
Journal of general internal medicine, Jan 16, 2015
We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling w... more We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling with DM genetic test results and counseling. In this randomized controlled trial, non-diabetic overweight/obese veteran outpatients aged 21 to 65 years received DM risk estimates for lifetime risk, family history, and fasting plasma glucose, followed by either genetic test results (CR+G; N = 303) or control eye disease counseling (CR+EYE; N = 298). All participants received brief lifestyle counseling encouraging weight loss to reduce the risk of DM. The mean age was 54 years, 53% of participants were black, and 80% were men. There was no difference between arms in weight (estimated mean difference between CR+G vs. CR+EYE at 3 months = 0.2 kg, 95% CI: -0.3 to 0.7; at 6 months = 0.4 kg, 95 % CI: -0.3 to 1.1), insulin resistance, perceived risk, or physical activity at 3 or 6 months. Calorie and fat intake were lower in the CR+G arm at 3 months (p's ≤ 0.05) but not at 6 months (p's &...
American Journal of Hypertension, 2010
Background The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent... more Background The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent telephonic behavioral lifestyle intervention, patient self-monitoring, and both interventions combined compared with usual care on reducing systolic blood pressure during 24 months. The combined intervention led to a significant reduction in systolic blood pressure compared with usual care alone. We examined direct and patient time costs associated with each intervention. Methods We conducted a prospective economic evaluation alongside a randomized controlled trial of 636 patients with hypertension participating in the study interventions. Medical costs were estimated using electronic data representing medical services delivered within the health system. Intervention-related costs were derived using information collected during the trial, administrative records, and published unit costs.
JAMA Ophthalmology, 2013
5. Schachtschabel DO, Binninger E. Stimulatory effects of ascorbic acid on hyaluronic acid synthe... more 5. Schachtschabel DO, Binninger E. Stimulatory effects of ascorbic acid on hyaluronic acid synthesis of in vitro cultured normal and glaucomatous trabecular meshwork cells of the human eye.
nature genetics • volume 22 • may 1999 19 et al. 1 , showing ORs of 2.13 and 2.17, respectively. ... more nature genetics • volume 22 • may 1999 19 et al. 1 , showing ORs of 2.13 and 2.17, respectively. Similar though non-significant trends were also observed in the NIA sample (P = 0.1; P = 0.1). Combined analyses of the NIMH and NIA samples showed significant genotypic (P = 0.007, OR=2.13, CI=1.22− 3.7) and allelic (P=0.003, OR=2.02, CI=1.3−3.2) associations with AD. We did not find associations between AD and A2M*2, or genotypes containing A2M*2, in a powerful, case-control sample. We did, however, detect significant but weaker associations in the NIMH sample than those quoted by Blacker et al. 1 using the same sample, together with similar but non-significant trends in an independent family sample (NIA). We believe the ORs we observed provide more accurate estimates of the effect sizes than those quoted originally 1. We conclude that if these data are not due to chance, A2M, or a gene in linkage disequilibrium with it, may be weakly associated with AD in some samples and may reflect either an interaction with other susceptibility gene/s segregating in these families or a stronger genetic effect in some of these families. Either case would limit the power of conventional case-control samples to detect association. the Conseil Régional du Nord-Pas de Calais axe régional de recherche sur les maladies neurodégénératives et le vieillissement cérébral and the
Value in Health, 2009
The cost savings following the use of Iodixanol compared to Iopromide in coronarography averaged ... more The cost savings following the use of Iodixanol compared to Iopromide in coronarography averaged 2287 RUB (72 USD) in common population, 2866 RUB (USD91) in patients with CKD, and 3427 RUB (US$109) in patients with diabetes mellitus and CKD. CONCLUSIONS: The results of this study demonstrated Iodixanol to be costsaving compared to low-osmolar contrast media both in risk groups and in general population.
Trials, 2012
Background: We describe the study design, procedures, and development of the risk counseling prot... more Background: We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. Methods/Design: Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m 2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion: A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling.
Patient Education and Counseling, 2008
Objectives-Evaluating a randomized controlled trial involving a tailored behavioral intervention ... more Objectives-Evaluating a randomized controlled trial involving a tailored behavioral intervention conducted to improve blood pressure control. Methods-Adults with hypertension from two outpatient primary care clinics were randomly allocated to receive a nurse-administered behavioral intervention or usual care. In this ongoing study, patients receive the tailored behavioral intervention bimonthly for two years via telephone; the goal of the intervention is to promote medication adherence and improve hypertension-related health behaviors. Patient factors targeted in the tailored behavioral intervention include perceived risk of hypertension and knowledge, memory, medical and social support, patients' relationship with their health care provider, adverse effects of medication therapy, weight management, exercise, diet, stress, smoking, and alcohol use. Results-The sample randomized to the behavioral intervention consisted of 319 adults with hypertension (average age = 60.5 years; 47% African-American). A comparable sample of adults was assigned to usual care (n=317). We had a 96% retention rate for the overall sample for the first 6 months of the study (93% at 12 months). The average phone call has lasted 18 minutes (range 2 to 51 minutes). From baseline to six months, self-reported medication adherence increased by 9% in the behavioral group vs. 1% in the non-behavioral group. Conclusion-The intervention is easily implemented and is designed to enhance adherence with prescribed hypertension regimen. The study includes both general and patient-tailored information based upon need assessment. The study design ensures internal validity as well as the ability to generalize study findings to the clinic settings.
Journal of General Internal Medicine, 2012
BACKGROUND: African Americans are significantly more likely than whites to have uncontrolled hype... more BACKGROUND: African Americans are significantly more likely than whites to have uncontrolled hypertension, contributing to significant disparities in cardiovascular disease and events. OBJECTIVE: The goal of this study was to examine whether there were differences in change in blood pressure (BP) for African American and non-Hispanic white patients in response to a medication management and tailored nurse-delivered telephone behavioral program. PARTICIPANTS: Five hundred and seventy-three patients (284 African American and 289 non-Hispanic white) primary care patients who participated in the Hypertension Intervention Nurse Telemedicine Study (HINTS) clinical trial. INTERVENTIONS: Study arms included: 1) nurseadministered, physician-directed medication management intervention, utilizing a validated clinical decision support system; 2) nurse-administered, behavioral management intervention; 3) combined behavioral management and medication management intervention; and 4) usual care. All interventions were activated based on poorly controlled home BP values. MAIN MEASURES: Post-hoc analysis of change in systolic and diastolic blood pressure. General linear models (PROC MIXED in SAS, version 9.2) were used to estimate predicted means at 6-month, 12-month, and 18-month time points, by intervention arm and race subgroups (separate models for systolic and diastolic blood pressure). KEY RESULTS: Improvement in mean systolic blood pressure post-baseline was greater for African Ameri-can patients in the combined intervention, compared to African American patients in usual care, at 12 months (6.6 mmHg; 95 % CI:-12.5,-0.7; p=0.03) and at 18 months (9.7 mmHg;-16.0,-3.4; p=0.003). At 18 months, mean diastolic BP was 4.8 mmHg lower (95 % CI:-8.5,-1.0; p=0.01) among African American patients in the combined intervention arm, compared to African American patients in usual care. There were no analogous differences for non-Hispanic white patients. CONCLUSIONS: The combination of home BP monitoring, remote medication management, and telephone tailored behavioral self-management appears to be particularly effective for improving BP among African Americans. The effect was not seen among non-Hispanic white patients.
Journal of General Internal Medicine, 2012
Genomics, 2000
The discussion of the prospects of using a dense map of single nucleotide polymorphisms (SNPs) to... more The discussion of the prospects of using a dense map of single nucleotide polymorphisms (SNPs) to identify disease genes with association analysis has been extensive. However, there is little empiric evidence to support this strategy. To begin to examine the practical issues surrounding this methodology, we identified 10 SNPs in the region immediately surrounding the apolipoprotein E locus (APOE), an established susceptibility gene for Alzheimer disease. Our goal was to examine patterns of allelic association to begin to investigate the question of whether APOE could have been identified using SNPs. Our strongest evidence of association was at the 2 SNPs immediately flanking APOE.
Digestive Diseases and Sciences, 2008
Purpose-To assess the accuracy of an NCI-developed colorectal cancer screening questionnaire. Met... more Purpose-To assess the accuracy of an NCI-developed colorectal cancer screening questionnaire. Methods-We conducted 36 cognitive interviews and made iterative changes to the questionnaire to improve comprehension. The revised questionnaire was administered face-to-face to 201 participants. The primary outcome was agreement between questionnaire responses and medical records for whether or not a participant was up-to-date for any colorectal cancer screening test. Results-Comprehension of descriptions and questions was generally good; however, the barium enema description required several revisions. The sensitivity of the questionnaire for up-to-date screening status was 94%, specificity was 63%, and concordance was 88%. Conclusions-The modified questionnaire was highly sensitive for determining if a person was up-to date for any colorectal cancer screening test, although the specificity was low. Given the difficulty of obtaining all relevant records, self-report using this questionnaire is a reasonable option for identifying people who have undergone testing.
Research investigators and clinicians are often interested in producing personalized risk graphs ... more Research investigators and clinicians are often interested in producing personalized risk graphs for research participants or patients. We used the GKPI procedure in SAS version 9.2 to produce batches of risk graphs for a randomized trial of an intervention to communicate participants’ individual risks for developing type 2 diabetes based on demographic, clinical, and genetic risk factors. We pilot-tested a variety of potential graphs with 35 participants to determine, based on participant feedback, which graphs were most easily understood and most clearly communicated risk. Graphs created by PROC GKPI can only be produced by hard coding the data values within the procedure rather than by passing the values to the procedure through the “DATA=Data Set Name” option. We present a macro and CALL EXECUTE code to demonstrate a method for producing batches of graphs without having to hard code the data values within the GKPI procedure. This paper presents the final versions of these risk g...
When you are creating “Table 1 – Demographics” type tables for journal articles or presentations,... more When you are creating “Table 1 – Demographics” type tables for journal articles or presentations, do you find it tedious to manually type or cut and paste output from SAS PROC FREQ or PROC UNIVARIATE into Microsoft Word documents? Do you find yourself spending a lot of time double-checking to make sure you didn’t make any typos during that process? Do you feel like you’re wasting precious time when you have to go back and manually redo a table because you discover that you should have presented your data stratified by an additional variable (such as race) rather than just your overall data? Fear not…there is a way to cut down on your effort and the need to check for typos with a little bit of up-front effort in SAS. This paper describes methods for automating the production of demographic-type tables by using PROC TEMPLATE, PROC FORMAT, PROC TABULATE, LABEL statements, and ODS RTF in SAS. In addition, this paper describes how the following special features can be used in SAS to make...
JAMA internal medicine, Jan 30, 2017
The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose... more The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose computed tomography for current and former heavy smokers aged 55 to 80 years. There is little published experience regarding implementing this recommendation in clinical practice. To describe organizational- and patient-level experiences with implementing an LCS program in selected Veterans Health Administration (VHA) hospitals and to estimate the number of VHA patients who may be candidates for LCS. This clinical demonstration project was conducted at 8 academic VHA hospitals among 93 033 primary care patients who were assessed on screening criteria; 2106 patients underwent LCS between July 1, 2013, and June 30, 2015. Implementation Guide and support, full-time LCS coordinators, electronic tools, tracking database, patient education materials, and radiologic and nodule follow-up guidelines. Description of implementation processes; percentages of patients who agreed to undergo LCS, had ...
Obesity Science & Practice, 2016
A weight loss maintenance trial involving weight loss prior to randomization is challenging to im... more A weight loss maintenance trial involving weight loss prior to randomization is challenging to implement due to the potential for dropout and insufficient weight loss. We examined rates and correlates of non-initiation, dropout, and insufficient weight loss during a weight loss maintenance trial. Methods The MAINTAIN trial involved a 16-week weight loss program followed by randomization among participants losing at least 4 kg. Psychosocial measures were administered during a screening visit. Weight was obtained at the first group session and 16 weeks later to determine eligibility for randomization. Results Of 573 patients who screened as eligible, 69 failed to initiate the weight loss program. In adjusted analyses, failure to initiate was associated with lower age, lack of a support person, and less encouragement for making dietary changes. Among participants who initiated, 200 dropped out, 82 lost insufficient weight, and 222 lost sufficient weight for randomization. Compared to losing sufficient weight, dropping out was associated with younger age and tobacco use, whereas losing insufficient weight was associated with non-White race and controlled motivation for physical activity. Conclusions Studies should be conducted to evaluate strategies to maximize recruitment and retention of subgroups that are less likely to initiate and be retained in weight loss maintenance trials.
Journal of the National Medical Association, 2009
Background-Individual variation in circulating insulin-like growth factor-I (IGF1) and its major ... more Background-Individual variation in circulating insulin-like growth factor-I (IGF1) and its major binding protein, insulin-like growth factor binding protein-3 (IGFBP3) have been etiologically linked to several chronic diseases, including some cancers. Factors associated with variation in circulating levels of these peptide hormones remain unclear. Methods-Multiple linear regression models were used to determine the extent to which sociodemographic characteristics, lifestyle factors, personal and family history of chronic disease, and common genetic variants, the (CA) n repeat polymorphism in the IGF1 promoter and the IGFBP3-202 A/C polymorphism (rs2854744) predict variation in IGF1 or IGFBP3 serum levels in 33 otherwise healthy African American and 37 white males recruited from Durham Veterans Administration Medical Center. Results-Predictors of serum IGF1, IGFBP3 and the IGF1:IGFBP3 molar ratio varied by race. In African Americans, 17% and 28% of the variation in serum IGF1 and the IGF1:IGFBP3 molar ratio, respectively, was explained by cigarette smoking and carrying the IGF1 (CA) 19 repeat allele, respectively. Not carrying at least one IGF1 (CA) 19 repeat allele and a high BMI explained 8%
Sleep, Jan 12, 2015
Sleep disorders are often unrecognized and/or poorly managed in primary care. Objective: To test ... more Sleep disorders are often unrecognized and/or poorly managed in primary care. Objective: To test a collaborative care model for interfacing sleep specialists with primary care providers to enhance patients' sleep disorders management. A prospective, randomized, parallel group, clinical intervention trial with patients assigned to an intervention (INT) or waiting-list, usual primary care (UPC) group. One university-affiliated Veterans Affairs (VA) Medical Center. A total of 137 adult (29 women) VA outpatients with sleep complaints. A one-time sleep specialty consultation with diagnostic feedback and treatment recommendations provided to the patient and the patient's primary care provider. Provider outcomes included rates of adherence to recommended diagnostic procedures and sleep-focused interventions. Patient outcomes included measures taken from sleep diaries and actigraphy; Pittsburgh Sleep Quality Index (PSQI) scores; and self-report measures of sleepiness, fatigue, mood,...
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, Jan 19, 2015
Regular screening with colonoscopy lowers colorectal cancer incidence and mortality. We aimed to ... more Regular screening with colonoscopy lowers colorectal cancer incidence and mortality. We aimed to determine patterns of repeat and surveillance colonoscopy and identify factors associated with over- and underuse of colonoscopy. We analyzed data from participants in a previous Veterans Health Administration (VHA) study who underwent outpatient colonoscopy at 25 VHA facilities between October 2007 and September 2008 (n=1455). The proportion of patients who received a follow-up colonoscopy was calculated for 3 risk groups, defined based on the index colonoscopy: no adenoma, low-risk adenoma, or high-risk adenoma. Colonoscopy was overused (used more frequently than intervals recommended by guidelines) by 16% of patients with no adenomas, 26% with low-risk adenomas, and 29% with high-risk adenomas. Most patients with high-risk adenomas (54%) underwent colonoscopy after the recommended interval or did not undergo colonoscopy. Patients who received a follow-up recommendation that was discor...
Bone, 2015
With ethical requirements to the enrollment of lower risk subjects, osteoporosis trials are under... more With ethical requirements to the enrollment of lower risk subjects, osteoporosis trials are underpowered to detect reduction in hip fractures. Different skeletal sites have different levels of fracture risk and response to treatment. We sought to identify fracture sites which cluster with hip fracture at higher than expected frequency; if these sites respond to treatment similarly, then a composite fracture endpoint could provide a better estimate of hip fracture reduction. Methods: Cohort study using Veterans Affairs and Medicare administrative data. Male Veterans (n=5,036,536) aged 50-99 years receiving VA primary care between1999-2009 were included. Fractures were ascertained using ICD9 and CPT codes and classified by skeletal site. Pearson correlation coefficients, logistic regression and kappa statistics, were used to describe the correlation between each fracture type and hip fracture within individuals, without regards to the timing of the events. Results: 595,579 (11.8%) men suffered 1 or more fractures and 179,597 (3.6%) suffered 2 or more fractures during the time under study. Of those with one or more fractures, rib was the most common site (29%), followed by spine (22%), hip (21%) and femur (20%). The fracture types most highly correlated with hip fracture were pelvic/acetabular (Pearson correlation coefficient 0.25, p<0.0001), femur (0.15, p<0.0001), and shoulder (0.11, p<0.0001). Conclusions: Pelvic, acetabular, femur, and shoulder fractures cluster with hip fractures within individuals at greater than expected frequency. If we observe similar treatment risk reductions within that cluster, subsequent trials could consider use of a composite endpoint to better estimate hip fracture risk.
Journal of general internal medicine, Jan 16, 2015
We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling w... more We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling with DM genetic test results and counseling. In this randomized controlled trial, non-diabetic overweight/obese veteran outpatients aged 21 to 65 years received DM risk estimates for lifetime risk, family history, and fasting plasma glucose, followed by either genetic test results (CR+G; N = 303) or control eye disease counseling (CR+EYE; N = 298). All participants received brief lifestyle counseling encouraging weight loss to reduce the risk of DM. The mean age was 54 years, 53% of participants were black, and 80% were men. There was no difference between arms in weight (estimated mean difference between CR+G vs. CR+EYE at 3 months = 0.2 kg, 95% CI: -0.3 to 0.7; at 6 months = 0.4 kg, 95 % CI: -0.3 to 1.1), insulin resistance, perceived risk, or physical activity at 3 or 6 months. Calorie and fat intake were lower in the CR+G arm at 3 months (p's ≤ 0.05) but not at 6 months (p's &...
American Journal of Hypertension, 2010
Background The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent... more Background The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent telephonic behavioral lifestyle intervention, patient self-monitoring, and both interventions combined compared with usual care on reducing systolic blood pressure during 24 months. The combined intervention led to a significant reduction in systolic blood pressure compared with usual care alone. We examined direct and patient time costs associated with each intervention. Methods We conducted a prospective economic evaluation alongside a randomized controlled trial of 636 patients with hypertension participating in the study interventions. Medical costs were estimated using electronic data representing medical services delivered within the health system. Intervention-related costs were derived using information collected during the trial, administrative records, and published unit costs.
JAMA Ophthalmology, 2013
5. Schachtschabel DO, Binninger E. Stimulatory effects of ascorbic acid on hyaluronic acid synthe... more 5. Schachtschabel DO, Binninger E. Stimulatory effects of ascorbic acid on hyaluronic acid synthesis of in vitro cultured normal and glaucomatous trabecular meshwork cells of the human eye.
nature genetics • volume 22 • may 1999 19 et al. 1 , showing ORs of 2.13 and 2.17, respectively. ... more nature genetics • volume 22 • may 1999 19 et al. 1 , showing ORs of 2.13 and 2.17, respectively. Similar though non-significant trends were also observed in the NIA sample (P = 0.1; P = 0.1). Combined analyses of the NIMH and NIA samples showed significant genotypic (P = 0.007, OR=2.13, CI=1.22− 3.7) and allelic (P=0.003, OR=2.02, CI=1.3−3.2) associations with AD. We did not find associations between AD and A2M*2, or genotypes containing A2M*2, in a powerful, case-control sample. We did, however, detect significant but weaker associations in the NIMH sample than those quoted by Blacker et al. 1 using the same sample, together with similar but non-significant trends in an independent family sample (NIA). We believe the ORs we observed provide more accurate estimates of the effect sizes than those quoted originally 1. We conclude that if these data are not due to chance, A2M, or a gene in linkage disequilibrium with it, may be weakly associated with AD in some samples and may reflect either an interaction with other susceptibility gene/s segregating in these families or a stronger genetic effect in some of these families. Either case would limit the power of conventional case-control samples to detect association. the Conseil Régional du Nord-Pas de Calais axe régional de recherche sur les maladies neurodégénératives et le vieillissement cérébral and the
Value in Health, 2009
The cost savings following the use of Iodixanol compared to Iopromide in coronarography averaged ... more The cost savings following the use of Iodixanol compared to Iopromide in coronarography averaged 2287 RUB (72 USD) in common population, 2866 RUB (USD91) in patients with CKD, and 3427 RUB (US$109) in patients with diabetes mellitus and CKD. CONCLUSIONS: The results of this study demonstrated Iodixanol to be costsaving compared to low-osmolar contrast media both in risk groups and in general population.
Trials, 2012
Background: We describe the study design, procedures, and development of the risk counseling prot... more Background: We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. Methods/Design: Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m 2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion: A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling.
Patient Education and Counseling, 2008
Objectives-Evaluating a randomized controlled trial involving a tailored behavioral intervention ... more Objectives-Evaluating a randomized controlled trial involving a tailored behavioral intervention conducted to improve blood pressure control. Methods-Adults with hypertension from two outpatient primary care clinics were randomly allocated to receive a nurse-administered behavioral intervention or usual care. In this ongoing study, patients receive the tailored behavioral intervention bimonthly for two years via telephone; the goal of the intervention is to promote medication adherence and improve hypertension-related health behaviors. Patient factors targeted in the tailored behavioral intervention include perceived risk of hypertension and knowledge, memory, medical and social support, patients' relationship with their health care provider, adverse effects of medication therapy, weight management, exercise, diet, stress, smoking, and alcohol use. Results-The sample randomized to the behavioral intervention consisted of 319 adults with hypertension (average age = 60.5 years; 47% African-American). A comparable sample of adults was assigned to usual care (n=317). We had a 96% retention rate for the overall sample for the first 6 months of the study (93% at 12 months). The average phone call has lasted 18 minutes (range 2 to 51 minutes). From baseline to six months, self-reported medication adherence increased by 9% in the behavioral group vs. 1% in the non-behavioral group. Conclusion-The intervention is easily implemented and is designed to enhance adherence with prescribed hypertension regimen. The study includes both general and patient-tailored information based upon need assessment. The study design ensures internal validity as well as the ability to generalize study findings to the clinic settings.
Journal of General Internal Medicine, 2012
BACKGROUND: African Americans are significantly more likely than whites to have uncontrolled hype... more BACKGROUND: African Americans are significantly more likely than whites to have uncontrolled hypertension, contributing to significant disparities in cardiovascular disease and events. OBJECTIVE: The goal of this study was to examine whether there were differences in change in blood pressure (BP) for African American and non-Hispanic white patients in response to a medication management and tailored nurse-delivered telephone behavioral program. PARTICIPANTS: Five hundred and seventy-three patients (284 African American and 289 non-Hispanic white) primary care patients who participated in the Hypertension Intervention Nurse Telemedicine Study (HINTS) clinical trial. INTERVENTIONS: Study arms included: 1) nurseadministered, physician-directed medication management intervention, utilizing a validated clinical decision support system; 2) nurse-administered, behavioral management intervention; 3) combined behavioral management and medication management intervention; and 4) usual care. All interventions were activated based on poorly controlled home BP values. MAIN MEASURES: Post-hoc analysis of change in systolic and diastolic blood pressure. General linear models (PROC MIXED in SAS, version 9.2) were used to estimate predicted means at 6-month, 12-month, and 18-month time points, by intervention arm and race subgroups (separate models for systolic and diastolic blood pressure). KEY RESULTS: Improvement in mean systolic blood pressure post-baseline was greater for African Ameri-can patients in the combined intervention, compared to African American patients in usual care, at 12 months (6.6 mmHg; 95 % CI:-12.5,-0.7; p=0.03) and at 18 months (9.7 mmHg;-16.0,-3.4; p=0.003). At 18 months, mean diastolic BP was 4.8 mmHg lower (95 % CI:-8.5,-1.0; p=0.01) among African American patients in the combined intervention arm, compared to African American patients in usual care. There were no analogous differences for non-Hispanic white patients. CONCLUSIONS: The combination of home BP monitoring, remote medication management, and telephone tailored behavioral self-management appears to be particularly effective for improving BP among African Americans. The effect was not seen among non-Hispanic white patients.
Journal of General Internal Medicine, 2012
Genomics, 2000
The discussion of the prospects of using a dense map of single nucleotide polymorphisms (SNPs) to... more The discussion of the prospects of using a dense map of single nucleotide polymorphisms (SNPs) to identify disease genes with association analysis has been extensive. However, there is little empiric evidence to support this strategy. To begin to examine the practical issues surrounding this methodology, we identified 10 SNPs in the region immediately surrounding the apolipoprotein E locus (APOE), an established susceptibility gene for Alzheimer disease. Our goal was to examine patterns of allelic association to begin to investigate the question of whether APOE could have been identified using SNPs. Our strongest evidence of association was at the 2 SNPs immediately flanking APOE.
Digestive Diseases and Sciences, 2008
Purpose-To assess the accuracy of an NCI-developed colorectal cancer screening questionnaire. Met... more Purpose-To assess the accuracy of an NCI-developed colorectal cancer screening questionnaire. Methods-We conducted 36 cognitive interviews and made iterative changes to the questionnaire to improve comprehension. The revised questionnaire was administered face-to-face to 201 participants. The primary outcome was agreement between questionnaire responses and medical records for whether or not a participant was up-to-date for any colorectal cancer screening test. Results-Comprehension of descriptions and questions was generally good; however, the barium enema description required several revisions. The sensitivity of the questionnaire for up-to-date screening status was 94%, specificity was 63%, and concordance was 88%. Conclusions-The modified questionnaire was highly sensitive for determining if a person was up-to date for any colorectal cancer screening test, although the specificity was low. Given the difficulty of obtaining all relevant records, self-report using this questionnaire is a reasonable option for identifying people who have undergone testing.