jennifer gassman | Cleveland Clinic (original) (raw)

Papers by jennifer gassman

Journal of the American Dietetic Association, 1994

The Modification of Diet in Renal Disease (MDRD) Feasibility Study was designed to test procedure... more The Modification of Diet in Renal Disease (MDRD) Feasibility Study was designed to test procedures and evaluate the feasibility of a full-scale clinical trial aimed at assessing the effects of reduction of dietary protein and phosphorus on progression of renal disease. Ninety-six patients with chronic renal insufficiency were randomly assigned to different diets in one of two studies depending on their glomerular filtration rate. The diets contained three different protein and phosphorus levels: moderate diet = 1.3 g protein per kilogram per day and 16 to 20 mg phosphorus per kilogram per day; low diet = 0.575 g protein per kilogram per day and 5 to 10 mg phosphorus per kilogram per day; and very low diet with keto or amino acids = 0.28 g protein per kilogram per day and 4 to 9 mg phosphorus per kilogram per day. Eight-five patients were monitored for at least 6 months; maximum follow-up was 22 months. Compliance with study diets was measured monthly using urea nitrogen appearance and 3-day diet diaries plus one 24-hour recall. The main outcome measure was change or maintenance of glomerular filtration rate. Data were analyzed by analysis of variance and paired t tests. Mean dietary protein intake, as determined by urea nitrogen appearance, decreased significantly in participants assigned to the diets low and very low in protein and phosphorus (P < .05). Overall, the follow-up protein intake (based on urea nitrogen appearance) as a percentage of baseline ranged from 45.8% to 83.1%. Analysis of diet diaries showed better dietary adherence than indicated by urea nitrogen appearance. Review of the exchange methodology used in dietary instruction suggests that imprecision of the exchange lists may have been a factor in the difficulty study participants had in achieving +/- 10% of the target protein goal. Based on the MDRD Feasibility Study, the protocol for the full-scale study was modified to include protein counting instead of food exchange methodology to monitor protein intake.

Controlled Clinical Trials

The American journal of otology, 1986

The distribution and variability of brain stem auditory evoked potentials (BAEP) were studied in ... more The distribution and variability of brain stem auditory evoked potentials (BAEP) were studied in 30 guinea pigs under controlled conditions. Coefficient of variation showed amplitude variables to have a greater intersubject variability than latency variables. However, amplitude variables were not found to be normally distributed. Therefore, evaluation of amplitude variables using statistics which assume that the underlying data are normally distributed can be misleading. One must either transform the data so they fit a normal distribution or use statistical methods that do not depend on a normal distribution. A nonparametric analysis study on amplitude variables in humans in recommended to update its clinical applicability.

The Anatomical Record, 1998

The kidneys of all Cetacea are composed of many small relatively independent kidneys (renicules) ... more The kidneys of all Cetacea are composed of many small relatively independent kidneys (renicules) containing considerable interrenicular tissue. Although reniculism is not entirely confined to the Cetacea, it is desirable to consider the possible advantage of reniculism to mammals of gigantic size. The kidneys of the killerwhale, Orcinus orca, are compared from this standpoint to the kidneys of diverse mammals. The specific renal parenchymal mass, glomerular counts, glomerular size, and specific glomerular mass of the killerwhale are measured and compared quantitatively (statistically) with similar data from numerous diverse mammals. Simultaneously, a method is described for enumerating the renicules of a cetacean kidney. Specific parenchymal mass of a killerwhale adult's two kidneys (0.33%) is close to the expected value for mammals of its adult body mass (2,087 kg). The diameter of the adult's glomerular capsules (153 microm) is strikingly less than that expected from its body mass (regression equation and graph for mammals in general). However, the number of glomeruli per kidney (approximately 100 x 10[6]) is markedly greater than that for mammals of its body mass (regression equation and graph for mammals in general) and is the first such count for a cetacean. The total glomerular mass relative to parenchymal renal mass of the O. orca infant and adult is, nevertheless, 5.5% and 6.0%, respectively, and is thus close to the general mammalian value of approximately 5%. Organization of a cetacean kidney into numerous renicules does not increase specific renal parenchymal mass or specific glomerular mass. The apparent advantage of numerous independent renicules is the limit that is afforded for length of tubules in the necessarily large kidneys of gigantic mammals.

Controlled Clinical Trials, 1995

analyses. 4) Outcome analysis models can be evaluated regarding expected power befbre trial unbli... more analyses. 4) Outcome analysis models can be evaluated regarding expected power befbre trial unblinding. This can include assessment of the time path of expected outcome events and selection of appropriate statistical model as well as specification of risk-treatment interaction if treatment is not expected to be equally efficacious across the patient risk spectrum. These methods have been developed most fully in studies for acute sepsis, although similar models and applications in other acute diseases such as COPD, pneumonia, intraabdominal infections, ARDS, and heart failure are under development.

Controlled Clinical Trials, 1995

Accurate assessment of adherence to medication regimens is a significant challenge in clinical tr... more Accurate assessment of adherence to medication regimens is a significant challenge in clinical trials. In the AASK Pilot Study, 94 participants were randomized to one of three antihypertensive regimens (atenolol, amlodipine, or enalapril) and to one of two levels of blood pressure control to assess their effects in slowing the progression of renal disease in hypertensive African Americans with moderately reduced renal function. Measures of adherence were pill counts and the Medication Events Monitoring System (MEMS) which records each time the vial is opened.

Controlled Clinical Trials, 1995

Abstracts two centers and age (55-69, 70 +). The interim analysis will be performed after every 2... more Abstracts two centers and age (55-69, 70 +). The interim analysis will be performed after every 200 patients have been randomized and subsequently, after every 100 patients. The equivalent fixed sample size design would require a total of 1085 patients. This design will provide unbiased estimates of the efficacy of the gel pad compared to standard foam mattress at the time of stopping. Consequently this design will provide a valid method of analysis together with a probable 35 % (conservative) reduction in the number of patients required, and therefore reduced costs.

Controlled Clinical Trials, 1996

American Journal of Kidney Diseases, 1997

Contr Clin Trial, 1995

Conclusion: Community accruak to clinicaI trials have similar inevaluabihty rates compared to a C... more Conclusion: Community accruak to clinicaI trials have similar inevaluabihty rates compared to a ComprehensiveCancer Center.

American Journal of Hypertension, 2003

African Americans are 6 times more likely to develop end-stage renal disease (ESRD) than whites. ... more African Americans are 6 times more likely to develop end-stage renal disease (ESRD) than whites. While observational studies show a direct relationship between the level of casual (office) BP and renal disease progression, level of casual BP can not account for the excess ESRD in African Americans. The primary objective of the AASK (African American Study of Kidney Disease and Hypertension) Cohort Study is to determine prospectively the course of kidney function and risk factors for kidney disease progression in African Americans with hypertensive kidney disease who receive recommended antihypertensive therapy that includes ramipril (JAMA, 2002;288:2421-2431. We hypothesize that abnormal diurnal patterns of BP, specifically, lack of a nocturnal decline in BP, may contribute to kidney disease progression in African Americans. In year 1 of the cohort phase of AASK, we performed ambulatory BP monitoring in 438 subjects. We defined daytime BP as the mean BP between 06:01-24:00 hours and nighttime BP as the mean BP between 00:01-06:00. Nocturnal fall of SBP was calculated as (daytime SBPnighttime SBP)/daytime SBP. Based on the nocturnal fall in SBP we classified subjects into 5 categories: extreme dippers (Ͼ20%), dippers (Ͼϭ10% to 20%), non-dippers (Ͻ10%), reverse dippers as 0 to -10% and extreme reverse dippers as Ͼ -10%. Mean daytime BP was 136/81 mm Hg and nighttime BP was 133/76 mm Hg. The distribution of nocturnal BP patterns is shown below:

Annals of Surgery

The therapy and survival rates of patients with esophageal carcinoma at the Cleveland Clinic over... more The therapy and survival rates of patients with esophageal carcinoma at the Cleveland Clinic over the 12-year period 1969-1980 are reviewed. Data on 238 patients were analyzed. Seventyone per cent of the patients underwent surgery, with esophagogastrectomy being performed in half of these. One or more early postoperative complications occurred in 72.6% of these patients.

Hemodialysis international. International Symposium on Home Hemodialysis, Jan 5, 2015

Hypertension is a common complication of chronic kidney disease and persists among most patients ... more Hypertension is a common complication of chronic kidney disease and persists among most patients with end-stage renal disease despite the provision of conventional thrice weekly hemodialysis (HD). We analyzed the effects of frequent HD on blood pressure in the randomized controlled Frequent Hemodialysis Network trials. The daily trial randomized 245 patients to 12 months of 6× ("frequent") vs. 3× ("conventional") weekly in-center hemodialysis; the nocturnal trial randomized 87 patients to 12 months of 6× weekly nocturnal HD vs. 3× weekly predominantly home-based hemodialysis. In the daily trial, compared with 3× weekly HD, 2 months of frequent HD lowered predialysis systolic blood pressure by -7.7 mmHg [95% confidence interval (CI): -11.9 to -3.5] and diastolic blood pressure by -3.9 mmHg [95% CI: -6.5 to -1.3]. In the nocturnal trial, compared with 3× weekly HD, 2 months of frequent HD lowered systolic blood pressure by -7.3 mmHg [95% CI: -14.2 to -0.3] and dias...

Kidney International, 2007

Observational studies suggest improvements with frequent hemodialysis (HD), but its true efficacy... more Observational studies suggest improvements with frequent hemodialysis (HD), but its true efficacy and safety remain uncertain. The Frequent Hemodialysis Network Trials Group is conducting two multicenter randomized trials of 250 subjects each, comparing conventional three times weekly HD with (1) in-center daily HD and (2) home nocturnal HD. Daily HD will be delivered for 1.5-2.75 h, 6 days/week, with target eK t /V n X0.9/session, whereas nocturnal HD will be delivered for X6 h, 6 nights/week, with target stdK t /V of X4.0/week. Subjects will be followed for 1 year. The composite of mortality with the 12-month change in (i) left ventricular mass index (LVMI) by magnetic resonance imaging, and (ii) SF-36 RAND Physical Health Composite (PHC) are specified as co-primary outcomes. The seven main secondary outcomes are between group comparisons of: change in LVMI, change in PHC, change in Beck Depression Inventory score, change in Trail Making Test B score, change in pre-HD serum albumin, change in pre-HD serum phosphorus, and rates of non-access hospitalization or death. Changes in blood pressure and erythropoeisis will also be assessed. Safety outcomes will focus on vascular access complications and burden of treatment. Data will be obtained on the cost of delivering frequent HD compared to conventional HD. Efforts will be made to reduce bias, including blinding assessment of subjective outcomes. Because no large-scale randomized trials of frequent HD have been previously conducted, the first year has been designated a Vanguard Phase, during which feasibility of randomization, ability to deliver the interventions, and adherence will be evaluated.

The New England journal of medicine, Jan 9, 2010

In this randomized clinical trial, we aimed to determine whether increasing the frequency of in-c... more In this randomized clinical trial, we aimed to determine whether increasing the frequency of in-center hemodialysis would result in beneficial changes in left ventricular mass, self-reported physical health, and other intermediate outcomes among patients undergoing maintenance hemodialysis.

Controlled Clinical Trials, 1996

Controlled Clinical Trials, 1993

Controlled Clinical Trials, 1995

Clinical Journal of the American Society of Nephrology, 2012

Abnormal ambulatory BP (ABP) profiles are commonplace in CKD, yet the prognostic value of ABP for... more Abnormal ambulatory BP (ABP) profiles are commonplace in CKD, yet the prognostic value of ABP for renal and cardiovascular outcomes is uncertain. This study assessed the relationship of baseline ABP profiles with CKD progression and subsequent cardiovascular outcomes to determine the prognostic value of ABP beyond that of clinic BP measurements. Between 2002 and 2003, 617 African Americans with hypertensive CKD treated to a clinic BP goal of <130/80 mmHg were enrolled in this prospective, observational study. Participants were followed for a median of 5 years. Primary renal outcome was a composite of doubling of serum creatinine, ESRD, or death. The primary cardiovascular outcome was a composite of myocardial infarction, hospitalized congestive heart failure, stroke, revascularization procedures, cardiovascular death, and ESRD. Multivariable Cox proportional hazard analysis showed that higher 24-hour systolic BP (SBP), daytime, night-time, and clinic SBP were each associated with subsequent renal (hazard ratio, 1.17-1.28; P<0.001) and cardiovascular outcomes (hazard ratio, 1.22-1.32; P<0.001). After controlling for clinic SBP, ABP measures were predictive of renal outcomes in participants with clinic SBP <130 mmHg (P<0.05 for interaction). ABP predicted cardiovascular outcomes with no interaction based on clinic BP control. ABP provides additional information beyond that of multiple clinic BP measures in predicting renal and cardiovascular outcomes in African Americans with hypertensive CKD. The primary utility of ABP in these CKD patients was to identify high-risk individuals among those patients with controlled clinic BP.

Blood Purification, 2011

End-stage renal disease patients experience significant impairments in health-related quality of ... more End-stage renal disease patients experience significant impairments in health-related quality of life (HRQOL). Testing various strategies to improve patient HRQOL in multicenter clinical trials, such as the Frequent Hemodialysis Network (FHN) trials is vitally important. The aim of this paper is to describe the design and conduct of HRQOL and patient-reported outcomes (PRO) assessment in the FHN trials. In the FHN trials, HRQOL was examined as a multidimensional concept, and the SF-36 RAND Physical Health Composite score was one of the co-primary outcomes. The instruments completed to assess HRQOL included the Medical Outcomes Study Short Form SF-36, Health Utilities Index 3, Sleep Problems Index, Beck Depression Inventory and feeling thermometer. These instruments have been shown to have high reliability, validity and responsiveness to change in the end-stage renal disease population. Additional items evaluating PRO including sexual function, time to recovery after dialysis and patients' self-perceived burden to caregiver were also assessed. All questionnaires were administered by trained interviewers using computer-assisted telephone interviewing to ensure blinding and minimizing selection bias. Interim analysis reveals that these instruments can be used to collect a comprehensive set of HRQOL measures with minimal patient burden. Accurate measurement of HRQOL and PRO can help us test whether hemodialysis interventions improve the health and well-being of this compromised patient population. We have shown that a comprehensive set of HRQOL measures can be centrally collected through telephone interviews in a blinded fashion, in a way that is well tolerated with minimum respondent burden.

Journal of the American Dietetic Association, 1994

The Modification of Diet in Renal Disease (MDRD) Feasibility Study was designed to test procedure... more The Modification of Diet in Renal Disease (MDRD) Feasibility Study was designed to test procedures and evaluate the feasibility of a full-scale clinical trial aimed at assessing the effects of reduction of dietary protein and phosphorus on progression of renal disease. Ninety-six patients with chronic renal insufficiency were randomly assigned to different diets in one of two studies depending on their glomerular filtration rate. The diets contained three different protein and phosphorus levels: moderate diet = 1.3 g protein per kilogram per day and 16 to 20 mg phosphorus per kilogram per day; low diet = 0.575 g protein per kilogram per day and 5 to 10 mg phosphorus per kilogram per day; and very low diet with keto or amino acids = 0.28 g protein per kilogram per day and 4 to 9 mg phosphorus per kilogram per day. Eight-five patients were monitored for at least 6 months; maximum follow-up was 22 months. Compliance with study diets was measured monthly using urea nitrogen appearance and 3-day diet diaries plus one 24-hour recall. The main outcome measure was change or maintenance of glomerular filtration rate. Data were analyzed by analysis of variance and paired t tests. Mean dietary protein intake, as determined by urea nitrogen appearance, decreased significantly in participants assigned to the diets low and very low in protein and phosphorus (P < .05). Overall, the follow-up protein intake (based on urea nitrogen appearance) as a percentage of baseline ranged from 45.8% to 83.1%. Analysis of diet diaries showed better dietary adherence than indicated by urea nitrogen appearance. Review of the exchange methodology used in dietary instruction suggests that imprecision of the exchange lists may have been a factor in the difficulty study participants had in achieving +/- 10% of the target protein goal. Based on the MDRD Feasibility Study, the protocol for the full-scale study was modified to include protein counting instead of food exchange methodology to monitor protein intake.

Controlled Clinical Trials

The American journal of otology, 1986

The distribution and variability of brain stem auditory evoked potentials (BAEP) were studied in ... more The distribution and variability of brain stem auditory evoked potentials (BAEP) were studied in 30 guinea pigs under controlled conditions. Coefficient of variation showed amplitude variables to have a greater intersubject variability than latency variables. However, amplitude variables were not found to be normally distributed. Therefore, evaluation of amplitude variables using statistics which assume that the underlying data are normally distributed can be misleading. One must either transform the data so they fit a normal distribution or use statistical methods that do not depend on a normal distribution. A nonparametric analysis study on amplitude variables in humans in recommended to update its clinical applicability.

The Anatomical Record, 1998

The kidneys of all Cetacea are composed of many small relatively independent kidneys (renicules) ... more The kidneys of all Cetacea are composed of many small relatively independent kidneys (renicules) containing considerable interrenicular tissue. Although reniculism is not entirely confined to the Cetacea, it is desirable to consider the possible advantage of reniculism to mammals of gigantic size. The kidneys of the killerwhale, Orcinus orca, are compared from this standpoint to the kidneys of diverse mammals. The specific renal parenchymal mass, glomerular counts, glomerular size, and specific glomerular mass of the killerwhale are measured and compared quantitatively (statistically) with similar data from numerous diverse mammals. Simultaneously, a method is described for enumerating the renicules of a cetacean kidney. Specific parenchymal mass of a killerwhale adult's two kidneys (0.33%) is close to the expected value for mammals of its adult body mass (2,087 kg). The diameter of the adult's glomerular capsules (153 microm) is strikingly less than that expected from its body mass (regression equation and graph for mammals in general). However, the number of glomeruli per kidney (approximately 100 x 10[6]) is markedly greater than that for mammals of its body mass (regression equation and graph for mammals in general) and is the first such count for a cetacean. The total glomerular mass relative to parenchymal renal mass of the O. orca infant and adult is, nevertheless, 5.5% and 6.0%, respectively, and is thus close to the general mammalian value of approximately 5%. Organization of a cetacean kidney into numerous renicules does not increase specific renal parenchymal mass or specific glomerular mass. The apparent advantage of numerous independent renicules is the limit that is afforded for length of tubules in the necessarily large kidneys of gigantic mammals.

Controlled Clinical Trials, 1995

analyses. 4) Outcome analysis models can be evaluated regarding expected power befbre trial unbli... more analyses. 4) Outcome analysis models can be evaluated regarding expected power befbre trial unblinding. This can include assessment of the time path of expected outcome events and selection of appropriate statistical model as well as specification of risk-treatment interaction if treatment is not expected to be equally efficacious across the patient risk spectrum. These methods have been developed most fully in studies for acute sepsis, although similar models and applications in other acute diseases such as COPD, pneumonia, intraabdominal infections, ARDS, and heart failure are under development.

Controlled Clinical Trials, 1995

Accurate assessment of adherence to medication regimens is a significant challenge in clinical tr... more Accurate assessment of adherence to medication regimens is a significant challenge in clinical trials. In the AASK Pilot Study, 94 participants were randomized to one of three antihypertensive regimens (atenolol, amlodipine, or enalapril) and to one of two levels of blood pressure control to assess their effects in slowing the progression of renal disease in hypertensive African Americans with moderately reduced renal function. Measures of adherence were pill counts and the Medication Events Monitoring System (MEMS) which records each time the vial is opened.

Controlled Clinical Trials, 1995

Abstracts two centers and age (55-69, 70 +). The interim analysis will be performed after every 2... more Abstracts two centers and age (55-69, 70 +). The interim analysis will be performed after every 200 patients have been randomized and subsequently, after every 100 patients. The equivalent fixed sample size design would require a total of 1085 patients. This design will provide unbiased estimates of the efficacy of the gel pad compared to standard foam mattress at the time of stopping. Consequently this design will provide a valid method of analysis together with a probable 35 % (conservative) reduction in the number of patients required, and therefore reduced costs.

Controlled Clinical Trials, 1996

American Journal of Kidney Diseases, 1997

Contr Clin Trial, 1995

Conclusion: Community accruak to clinicaI trials have similar inevaluabihty rates compared to a C... more Conclusion: Community accruak to clinicaI trials have similar inevaluabihty rates compared to a ComprehensiveCancer Center.

American Journal of Hypertension, 2003

African Americans are 6 times more likely to develop end-stage renal disease (ESRD) than whites. ... more African Americans are 6 times more likely to develop end-stage renal disease (ESRD) than whites. While observational studies show a direct relationship between the level of casual (office) BP and renal disease progression, level of casual BP can not account for the excess ESRD in African Americans. The primary objective of the AASK (African American Study of Kidney Disease and Hypertension) Cohort Study is to determine prospectively the course of kidney function and risk factors for kidney disease progression in African Americans with hypertensive kidney disease who receive recommended antihypertensive therapy that includes ramipril (JAMA, 2002;288:2421-2431. We hypothesize that abnormal diurnal patterns of BP, specifically, lack of a nocturnal decline in BP, may contribute to kidney disease progression in African Americans. In year 1 of the cohort phase of AASK, we performed ambulatory BP monitoring in 438 subjects. We defined daytime BP as the mean BP between 06:01-24:00 hours and nighttime BP as the mean BP between 00:01-06:00. Nocturnal fall of SBP was calculated as (daytime SBPnighttime SBP)/daytime SBP. Based on the nocturnal fall in SBP we classified subjects into 5 categories: extreme dippers (Ͼ20%), dippers (Ͼϭ10% to 20%), non-dippers (Ͻ10%), reverse dippers as 0 to -10% and extreme reverse dippers as Ͼ -10%. Mean daytime BP was 136/81 mm Hg and nighttime BP was 133/76 mm Hg. The distribution of nocturnal BP patterns is shown below:

Annals of Surgery

The therapy and survival rates of patients with esophageal carcinoma at the Cleveland Clinic over... more The therapy and survival rates of patients with esophageal carcinoma at the Cleveland Clinic over the 12-year period 1969-1980 are reviewed. Data on 238 patients were analyzed. Seventyone per cent of the patients underwent surgery, with esophagogastrectomy being performed in half of these. One or more early postoperative complications occurred in 72.6% of these patients.

Hemodialysis international. International Symposium on Home Hemodialysis, Jan 5, 2015

Hypertension is a common complication of chronic kidney disease and persists among most patients ... more Hypertension is a common complication of chronic kidney disease and persists among most patients with end-stage renal disease despite the provision of conventional thrice weekly hemodialysis (HD). We analyzed the effects of frequent HD on blood pressure in the randomized controlled Frequent Hemodialysis Network trials. The daily trial randomized 245 patients to 12 months of 6× ("frequent") vs. 3× ("conventional") weekly in-center hemodialysis; the nocturnal trial randomized 87 patients to 12 months of 6× weekly nocturnal HD vs. 3× weekly predominantly home-based hemodialysis. In the daily trial, compared with 3× weekly HD, 2 months of frequent HD lowered predialysis systolic blood pressure by -7.7 mmHg [95% confidence interval (CI): -11.9 to -3.5] and diastolic blood pressure by -3.9 mmHg [95% CI: -6.5 to -1.3]. In the nocturnal trial, compared with 3× weekly HD, 2 months of frequent HD lowered systolic blood pressure by -7.3 mmHg [95% CI: -14.2 to -0.3] and dias...

Kidney International, 2007

Observational studies suggest improvements with frequent hemodialysis (HD), but its true efficacy... more Observational studies suggest improvements with frequent hemodialysis (HD), but its true efficacy and safety remain uncertain. The Frequent Hemodialysis Network Trials Group is conducting two multicenter randomized trials of 250 subjects each, comparing conventional three times weekly HD with (1) in-center daily HD and (2) home nocturnal HD. Daily HD will be delivered for 1.5-2.75 h, 6 days/week, with target eK t /V n X0.9/session, whereas nocturnal HD will be delivered for X6 h, 6 nights/week, with target stdK t /V of X4.0/week. Subjects will be followed for 1 year. The composite of mortality with the 12-month change in (i) left ventricular mass index (LVMI) by magnetic resonance imaging, and (ii) SF-36 RAND Physical Health Composite (PHC) are specified as co-primary outcomes. The seven main secondary outcomes are between group comparisons of: change in LVMI, change in PHC, change in Beck Depression Inventory score, change in Trail Making Test B score, change in pre-HD serum albumin, change in pre-HD serum phosphorus, and rates of non-access hospitalization or death. Changes in blood pressure and erythropoeisis will also be assessed. Safety outcomes will focus on vascular access complications and burden of treatment. Data will be obtained on the cost of delivering frequent HD compared to conventional HD. Efforts will be made to reduce bias, including blinding assessment of subjective outcomes. Because no large-scale randomized trials of frequent HD have been previously conducted, the first year has been designated a Vanguard Phase, during which feasibility of randomization, ability to deliver the interventions, and adherence will be evaluated.

The New England journal of medicine, Jan 9, 2010

In this randomized clinical trial, we aimed to determine whether increasing the frequency of in-c... more In this randomized clinical trial, we aimed to determine whether increasing the frequency of in-center hemodialysis would result in beneficial changes in left ventricular mass, self-reported physical health, and other intermediate outcomes among patients undergoing maintenance hemodialysis.

Controlled Clinical Trials, 1996

Controlled Clinical Trials, 1993

Controlled Clinical Trials, 1995

Clinical Journal of the American Society of Nephrology, 2012

Abnormal ambulatory BP (ABP) profiles are commonplace in CKD, yet the prognostic value of ABP for... more Abnormal ambulatory BP (ABP) profiles are commonplace in CKD, yet the prognostic value of ABP for renal and cardiovascular outcomes is uncertain. This study assessed the relationship of baseline ABP profiles with CKD progression and subsequent cardiovascular outcomes to determine the prognostic value of ABP beyond that of clinic BP measurements. Between 2002 and 2003, 617 African Americans with hypertensive CKD treated to a clinic BP goal of <130/80 mmHg were enrolled in this prospective, observational study. Participants were followed for a median of 5 years. Primary renal outcome was a composite of doubling of serum creatinine, ESRD, or death. The primary cardiovascular outcome was a composite of myocardial infarction, hospitalized congestive heart failure, stroke, revascularization procedures, cardiovascular death, and ESRD. Multivariable Cox proportional hazard analysis showed that higher 24-hour systolic BP (SBP), daytime, night-time, and clinic SBP were each associated with subsequent renal (hazard ratio, 1.17-1.28; P<0.001) and cardiovascular outcomes (hazard ratio, 1.22-1.32; P<0.001). After controlling for clinic SBP, ABP measures were predictive of renal outcomes in participants with clinic SBP <130 mmHg (P<0.05 for interaction). ABP predicted cardiovascular outcomes with no interaction based on clinic BP control. ABP provides additional information beyond that of multiple clinic BP measures in predicting renal and cardiovascular outcomes in African Americans with hypertensive CKD. The primary utility of ABP in these CKD patients was to identify high-risk individuals among those patients with controlled clinic BP.

Blood Purification, 2011

End-stage renal disease patients experience significant impairments in health-related quality of ... more End-stage renal disease patients experience significant impairments in health-related quality of life (HRQOL). Testing various strategies to improve patient HRQOL in multicenter clinical trials, such as the Frequent Hemodialysis Network (FHN) trials is vitally important. The aim of this paper is to describe the design and conduct of HRQOL and patient-reported outcomes (PRO) assessment in the FHN trials. In the FHN trials, HRQOL was examined as a multidimensional concept, and the SF-36 RAND Physical Health Composite score was one of the co-primary outcomes. The instruments completed to assess HRQOL included the Medical Outcomes Study Short Form SF-36, Health Utilities Index 3, Sleep Problems Index, Beck Depression Inventory and feeling thermometer. These instruments have been shown to have high reliability, validity and responsiveness to change in the end-stage renal disease population. Additional items evaluating PRO including sexual function, time to recovery after dialysis and patients' self-perceived burden to caregiver were also assessed. All questionnaires were administered by trained interviewers using computer-assisted telephone interviewing to ensure blinding and minimizing selection bias. Interim analysis reveals that these instruments can be used to collect a comprehensive set of HRQOL measures with minimal patient burden. Accurate measurement of HRQOL and PRO can help us test whether hemodialysis interventions improve the health and well-being of this compromised patient population. We have shown that a comprehensive set of HRQOL measures can be centrally collected through telephone interviews in a blinded fashion, in a way that is well tolerated with minimum respondent burden.