Introduction Electronic health record (EHR) or medical claims-based algorithms (i.e., operational... more Introduction Electronic health record (EHR) or medical claims-based algorithms (i.e., operational definitions) can be used to define safety outcomes using real-world data. However, existing tools do not allow researchers and decision-makers to adequately appraise whether a particular algorithm is fit for purpose (FFP) to support regulatory decisions on drug safety surveillance. Our objective was to develop a tool to enable regulatory decision-makers and other stakeholders to appraise whether a given algorithm is FFP for a specific decision context. Methods We drafted a set of 77 generic items informed by regulatory guidance documents, existing instruments, and publications. The outcome of ischemic stroke served as an exemplar to inform the development of draft items. The items were designed to be outcome independent. We conducted a three-round online Delphi panel to develop and refine the tool and achieve consensus on items (> 70% agreement) among panel participants composed of regulators, researchers from pharmaceutical organizations, academic clinicians, methodologists, pharmacoepidemiologists, and cardiologists. We conducted a qualitative analysis of panel responses. Five pairs of reviewers independently evaluated two ischemic stroke algorithm validation studies to test its application. We developed a user guide, with explanation and elaboration for each item, guidance on essential and additional elements for user responses, and an illustrative example of a complete assessment. Furthermore, we conducted a 2-h online stakeholder panel of 16 participants from regulatory agencies, academic institutions, and industry. We solicited input on key factors for an FFP assessment, their general reaction to the Algorithm CErtaInty Tool (ACE-IT), limitations of the tool, and its potential use. Results The expert panel reviewed and made changes to the initial list of 77 items. The panel achieved consensus on 38 items, and the final version of the ACE-IT includes 34 items after removal of duplicate items. Applying the tool to two ischemic stroke algorithms demonstrated challenges in its application and identified shared concepts addressed by more than one item. The ACE-IT was viewed positively by the majority of stakeholders. They identified that the tool could serve as an educational resource as well as an information-sharing platform. The time required to complete the assessment was identified as an important limitation. We consolidated items with shared concepts and added a preliminary screen section and a summary assessment box based on their input. The final version of the ACE-IT is a 34-item tool for assessing whether algorithm validation studies on safety outcomes are FFP. It comprises the domains of internal validity (24 items), external validity (seven items), and ethical conduct and reporting of the validation study (three items). The internal validity domain includes sections on objectives, data sources, population, outcomes, design and setting, statistical methods, reference standard, accuracy, and strengths and limitations. The external validity domain includes items that assess the generalizability to a proposed target study. The domain on ethics and transparency includes items on ethical conduct and reporting of the validation study. Conclusion The ACE-IT supports a structured, transparent, and flexible approach for decision-makers to appraise whether electronic health record or medical claims-based algorithms for safety outcomes are FFP for a specific decision context. Reliability and validity testing using a larger sample of participants in other therapeutic areas and further modifications to reduce the time needed to complete the assessment are needed to fully evaluate its utility for regulatory decision-making.
The correct title of the article [1] should be "Integrating multiple data sources (MUDS) for... more The correct title of the article [1] should be "Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol". The article is a protocol for a methodological study, not a systematic review.
The federal and provincial governments have undertaken a universal immunization program to protec... more The federal and provincial governments have undertaken a universal immunization program to protect school-aged girls against cervical cancer using the new human papillomavirus vaccine Gardasil®. While the vaccine appears to be effective and safe, there are a number of important unanswered questions regarding it and the effects of the immunization program. Here we briefly review key literature about the vaccine and then use the Erickson criteria, which offer an evidence basis for decision-making regarding national immunization strategies, to evaluate whether the program is congruent with sound public health policy. Our analysis of the national decision to recommend and fund a vaccination program using Gardasil® raises significant questions about the basis for this program.
Publish with Bio Med Central and every scientist can read your work free of charge "BioMed Centra... more Publish with Bio Med Central and every scientist can read your work free of charge "BioMed Central will be the most significant development for disseminating the results of biomedical researc h in our lifetime."
Philosophy, Ethics, and Humanities in Medicine, 2007
Public health ethics is neither taught widely in medical schools or schools of public health in t... more Public health ethics is neither taught widely in medical schools or schools of public health in the US or around the world. It is not surprising that health care professionals are particularly challenged when faced with ethical questions which extend beyond safeguarding the interests of their individual patients to matters that affect overall public good. The perceived threat of terror after September 11 2007, the anthrax attacks and the Katrina debacle are recent circumstances which may result in coercion. These have piqued the interest of medical professionals and the general public on public health ethics. The Ethics of Coercion in Mass Casualty Medicine written by Griffin Trotter MD, PhD attempts to fill a timely void in this area by examining the ethics of coercion in times of public health disasters.
This study aimed to identify the risk association between pioglitazone exposure and bladder cance... more This study aimed to identify the risk association between pioglitazone exposure and bladder cancer. A nested case–control study was performed using a representative database randomly sampled from National Health Insurance enrollees. The source cohort consisted of newly diagnosed diabetic patients from 1997 to 2009. Cases were identified as those with a diagnosis of bladder cancer from 2002 to 2009. For each case, four matched control individuals were randomly selected. A multiple logistic regression model was used to estimate the relative magnitude of risk in relation to the use of pioglitazone. In total, 259 cases and 1036 controls were identified. The prevalent use of pioglitazone is similar in cases and controls (adjusted odds ratio, 1.20; 95% confidence interval, 0.58–2.49). Compared to nonusers, these values were 1.08 (0.41–2.88) for those with cumulative pioglitazone use ≤ 8268 mg and 1.35 (0.48–3.79) for those with cumulative pioglitazone use > 8268 mg. This study does not...
A 2‐stage survey was carried out to establish the point‐prevalence of mental disorders and help‐s... more A 2‐stage survey was carried out to establish the point‐prevalence of mental disorders and help‐seeking behaviour in children aged 8, 11 and 15 living in the city of Valencia. Global prevalence rates, rates by age and rates by sex, as well as rates of specific diagnosis according to DSM‐III‐R criteria are described. Help‐seeking behaviour was found to be related to an interaction between internalizing and externalizing symptoms and sex.
Context Potentially inappropriate prescribing of medications in older adults, particular those wi... more Context Potentially inappropriate prescribing of medications in older adults, particular those with dementia, can lead to adverse drug events including falls and fractures, worsening cognitive impairment, emergency department visits, and hospitalizations. Educational mailings from health plans to patients and their providers to encourage deprescribing conversations may represent an effective, low-cost, "light touch", approach to reducing the burden of potentially inappropriate prescription use in older adults with dementia. Objectives The objective of the Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease (D-PRESCRIBE-AD) trial is to evaluate the effect of a health plan based multi-faceted educational outreach
We report a unusual case of idiopathic nodular glomerulosclerosis mimicking changes that develop ... more We report a unusual case of idiopathic nodular glomerulosclerosis mimicking changes that develop in diabetic nephropathy. A 66-year-old non-diabetic female developed nephrotic range proteinuria and the work up was unremarkable. Light and electron microscopy showed mesangial expansion with Kimmelsteil-Wilson nodules and diffuse glomerular basement membrane thickening without any electron dense deposits. Diabetes mellitus was excluded by repeated clinical and laboratory investigations. Forty two similar cases have been reported. Exact etiology for the development of non-diabetic glomerulosclerosis is unclear. But, hypertension, smoking, obesity, intermittent hyperglycemia predating the diagnosis of diabetes possibly explain the development of nodular glomerulosclerosis in these patients. Long-term follow-up to screen for the delayed onset of diabetes or its complications may be worthwhile.
Cocaine-induced acute renal failure has been reported in association with rhabdomyolysis. We desc... more Cocaine-induced acute renal failure has been reported in association with rhabdomyolysis. We describe a case of a young African American male who developed acute renal failure, which possibly occurred after inhalation of cocaine without concomitant rhabdomyolysis. His renal function recovered with supportive hydration. The most likely mechanism was intense vasoconstriction. Clinicians need to be mindful of this unique feature of cocaine intoxication.
MedGenMed : Medscape general medicine, Jan 14, 2004
A 74-year-old, white woman was admitted to the hospital for pleural effusion. Her medical history... more A 74-year-old, white woman was admitted to the hospital for pleural effusion. Her medical history included orthotopic cardiac transplantation, hypertension, hypercholesterolemia, peripheral vascular disease, diabetes mellitus, and renal insufficiency secondary to cyclosporine. She was on ...
Objectives: B-type natriuretic peptide (BNP) levels have been associated with sudden cardiac deat... more Objectives: B-type natriuretic peptide (BNP) levels have been associated with sudden cardiac death among patients with congestive heart failure (CHF). However, the relationship between BNP levels and arrhythmogenic substrates is poorly understood. We assessed whether there is a correlation between N-terminal pro-BNP levels (ProBNP) and device therapies in patients with CHF and defibrillators (ICD) or biventricular pacemakers-ICD (BiV-ICD). Methods: ProBNP levels were analyzed in 24 patients (19 men, age 64.2 Ϯ 12 years) with dilated cardiomyopathy (DCM), CHF, and ICD or BiV-ICD. Levels were studied among patients with and without device therapies. In patients with therapies, baseline ProBNP measurements were compared with the closest-to-therapy level. A two-tailed paired t test analyzed differences of mean ProBNP plasma levels. Results: Eighteen patients had ischemic and six nonischemic DCM; left ventricular ejection fraction. 25.1 Ϯ 6.1%. Twelve patients had BiV-ICD and 12 had ICD. Ten patients received therapies during a mean follow-up of 171 days: five appropriate therapies for VT/VF and five inappropriate therapies for atrial tachycardia. No change in the functional class of CHF preceded device therapies. There was no difference between baseline ProBNP levels in patients with therapies versus no therapies (therapies, 1800 Ϯ 1712 pg/mL; no therapies, 2587 Ϯ 2433 pg/mL; P value, 0.56). In the group with therapies, closest-totherapy ProBNP levels drawn within 3 days were higher than baseline levels in the limit of statistical significance (therapies, 3816.2 Ϯ 2842 pg/mL vs baseline, 1860.6 Ϯ 1398 pg/mL; P value, 0.05). Conclusions: In patients with CHF and defibrillation devices, baseline ProBNP levels were not different among patients that received device therapies as compared with patients without therapies. Closest-to-therapy ProBNP levels showed a trend to higher levels as compared with baseline. More severe left ventricular damage and greater hemodynamic derangement may account for higher proBNP levels in patients with device therapies. *This abstract was one of 25 selected for oral presentation in SMA's Physicians-in-Training Competition.
African Americans are over-represented in the endstage renal disease (ESRD) population in the Uni... more African Americans are over-represented in the endstage renal disease (ESRD) population in the United States secondary to the higher incidence of diabetes and hypertension (1). Their lower socioeconomic status and poor access to health care worsens this problem. The total number of renal transplantations done in the United States is increasing. Renal transplantation has improved the mortality, morbidity, and quality of life for patients with ESRD in comparison with patients continuing on dialysis (2). Similar to the disparities that exist in other medical procedures, African Americans with ESRD are less likely than whites to undergo renal transplantation despite being younger than whites (younger patients do better with transplantation) (3-5). Epidemiologic studies have shown that differences between whites and African Americans exist Navaneethan SD, Singh S. A systematic review of barriers in access to renal transplantation among African Americans in the United States.
Background: To identify patient and health system characteristics associated with late referral o... more Background: To identify patient and health system characteristics associated with late referral of patients with chronic kidney disease to nephrologists. Methods: MEDLINE, CENTRAL, and CINAHL were searched using the appropriate MESH terms in March 2007. Two reviewers individually and in duplicate reviewed the abstracts of 256 articles and selected 18 observational studies for inclusion. The reasons for late referral were categorized into patient or health system characteristics. Data extraction and content appraisal were done using a prespecified protocol. Results: Older age, the existence of multiple comorbidities, race other than Caucasian, lack of insurance, lower socioeconomic status and educational levels were patient characteristics associated with late referral of patients with chronic kidney disease. Lack of referring physician knowledge about the appropriate timing of referral, absence of communication between referring physicians and nephrologists, and dialysis care delivered at tertiary medical centers were health system characteristics associated with late referral of patients with chronic kidney disease. Most studies identified multiple factors associated with late referral, although the relative importance and the combined effect of these factors were not systematically evaluated. Conclusion: A combination of patient and health system characteristics is associated with late referral of patients with chronic kidney disease. Overall, being older, belonging to a minority group, being less educated, being uninsured, suffering from multiple comorbidities, and the lack of communication between primary care physicians and nephrologists contribute to late referral of patients with chronic kidney disease. Both primary care physicians and nephrologists need to engage in multisectoral collaborative efforts that ensure patient education and enhance physician awareness to improve the care of patients with chronic kidney disease. Background Chronic kidney disease is an emerging public health problem. A recent study reported that nearly 26 million Americans suffer from Chronic Kidney Disease (CKD) [1]. Future projections for the US population estimate more than 700,000 prevalent cases of End Stage Renal Disease (ESRD) by the year 2015 [2]. Observational studies and their meta-analysis have shown that late referral of
Introduction Electronic health record (EHR) or medical claims-based algorithms (i.e., operational... more Introduction Electronic health record (EHR) or medical claims-based algorithms (i.e., operational definitions) can be used to define safety outcomes using real-world data. However, existing tools do not allow researchers and decision-makers to adequately appraise whether a particular algorithm is fit for purpose (FFP) to support regulatory decisions on drug safety surveillance. Our objective was to develop a tool to enable regulatory decision-makers and other stakeholders to appraise whether a given algorithm is FFP for a specific decision context. Methods We drafted a set of 77 generic items informed by regulatory guidance documents, existing instruments, and publications. The outcome of ischemic stroke served as an exemplar to inform the development of draft items. The items were designed to be outcome independent. We conducted a three-round online Delphi panel to develop and refine the tool and achieve consensus on items (> 70% agreement) among panel participants composed of regulators, researchers from pharmaceutical organizations, academic clinicians, methodologists, pharmacoepidemiologists, and cardiologists. We conducted a qualitative analysis of panel responses. Five pairs of reviewers independently evaluated two ischemic stroke algorithm validation studies to test its application. We developed a user guide, with explanation and elaboration for each item, guidance on essential and additional elements for user responses, and an illustrative example of a complete assessment. Furthermore, we conducted a 2-h online stakeholder panel of 16 participants from regulatory agencies, academic institutions, and industry. We solicited input on key factors for an FFP assessment, their general reaction to the Algorithm CErtaInty Tool (ACE-IT), limitations of the tool, and its potential use. Results The expert panel reviewed and made changes to the initial list of 77 items. The panel achieved consensus on 38 items, and the final version of the ACE-IT includes 34 items after removal of duplicate items. Applying the tool to two ischemic stroke algorithms demonstrated challenges in its application and identified shared concepts addressed by more than one item. The ACE-IT was viewed positively by the majority of stakeholders. They identified that the tool could serve as an educational resource as well as an information-sharing platform. The time required to complete the assessment was identified as an important limitation. We consolidated items with shared concepts and added a preliminary screen section and a summary assessment box based on their input. The final version of the ACE-IT is a 34-item tool for assessing whether algorithm validation studies on safety outcomes are FFP. It comprises the domains of internal validity (24 items), external validity (seven items), and ethical conduct and reporting of the validation study (three items). The internal validity domain includes sections on objectives, data sources, population, outcomes, design and setting, statistical methods, reference standard, accuracy, and strengths and limitations. The external validity domain includes items that assess the generalizability to a proposed target study. The domain on ethics and transparency includes items on ethical conduct and reporting of the validation study. Conclusion The ACE-IT supports a structured, transparent, and flexible approach for decision-makers to appraise whether electronic health record or medical claims-based algorithms for safety outcomes are FFP for a specific decision context. Reliability and validity testing using a larger sample of participants in other therapeutic areas and further modifications to reduce the time needed to complete the assessment are needed to fully evaluate its utility for regulatory decision-making.
The correct title of the article [1] should be "Integrating multiple data sources (MUDS) for... more The correct title of the article [1] should be "Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol". The article is a protocol for a methodological study, not a systematic review.
The federal and provincial governments have undertaken a universal immunization program to protec... more The federal and provincial governments have undertaken a universal immunization program to protect school-aged girls against cervical cancer using the new human papillomavirus vaccine Gardasil®. While the vaccine appears to be effective and safe, there are a number of important unanswered questions regarding it and the effects of the immunization program. Here we briefly review key literature about the vaccine and then use the Erickson criteria, which offer an evidence basis for decision-making regarding national immunization strategies, to evaluate whether the program is congruent with sound public health policy. Our analysis of the national decision to recommend and fund a vaccination program using Gardasil® raises significant questions about the basis for this program.
Publish with Bio Med Central and every scientist can read your work free of charge "BioMed Centra... more Publish with Bio Med Central and every scientist can read your work free of charge "BioMed Central will be the most significant development for disseminating the results of biomedical researc h in our lifetime."
Philosophy, Ethics, and Humanities in Medicine, 2007
Public health ethics is neither taught widely in medical schools or schools of public health in t... more Public health ethics is neither taught widely in medical schools or schools of public health in the US or around the world. It is not surprising that health care professionals are particularly challenged when faced with ethical questions which extend beyond safeguarding the interests of their individual patients to matters that affect overall public good. The perceived threat of terror after September 11 2007, the anthrax attacks and the Katrina debacle are recent circumstances which may result in coercion. These have piqued the interest of medical professionals and the general public on public health ethics. The Ethics of Coercion in Mass Casualty Medicine written by Griffin Trotter MD, PhD attempts to fill a timely void in this area by examining the ethics of coercion in times of public health disasters.
This study aimed to identify the risk association between pioglitazone exposure and bladder cance... more This study aimed to identify the risk association between pioglitazone exposure and bladder cancer. A nested case–control study was performed using a representative database randomly sampled from National Health Insurance enrollees. The source cohort consisted of newly diagnosed diabetic patients from 1997 to 2009. Cases were identified as those with a diagnosis of bladder cancer from 2002 to 2009. For each case, four matched control individuals were randomly selected. A multiple logistic regression model was used to estimate the relative magnitude of risk in relation to the use of pioglitazone. In total, 259 cases and 1036 controls were identified. The prevalent use of pioglitazone is similar in cases and controls (adjusted odds ratio, 1.20; 95% confidence interval, 0.58–2.49). Compared to nonusers, these values were 1.08 (0.41–2.88) for those with cumulative pioglitazone use ≤ 8268 mg and 1.35 (0.48–3.79) for those with cumulative pioglitazone use > 8268 mg. This study does not...
A 2‐stage survey was carried out to establish the point‐prevalence of mental disorders and help‐s... more A 2‐stage survey was carried out to establish the point‐prevalence of mental disorders and help‐seeking behaviour in children aged 8, 11 and 15 living in the city of Valencia. Global prevalence rates, rates by age and rates by sex, as well as rates of specific diagnosis according to DSM‐III‐R criteria are described. Help‐seeking behaviour was found to be related to an interaction between internalizing and externalizing symptoms and sex.
Context Potentially inappropriate prescribing of medications in older adults, particular those wi... more Context Potentially inappropriate prescribing of medications in older adults, particular those with dementia, can lead to adverse drug events including falls and fractures, worsening cognitive impairment, emergency department visits, and hospitalizations. Educational mailings from health plans to patients and their providers to encourage deprescribing conversations may represent an effective, low-cost, "light touch", approach to reducing the burden of potentially inappropriate prescription use in older adults with dementia. Objectives The objective of the Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease (D-PRESCRIBE-AD) trial is to evaluate the effect of a health plan based multi-faceted educational outreach
We report a unusual case of idiopathic nodular glomerulosclerosis mimicking changes that develop ... more We report a unusual case of idiopathic nodular glomerulosclerosis mimicking changes that develop in diabetic nephropathy. A 66-year-old non-diabetic female developed nephrotic range proteinuria and the work up was unremarkable. Light and electron microscopy showed mesangial expansion with Kimmelsteil-Wilson nodules and diffuse glomerular basement membrane thickening without any electron dense deposits. Diabetes mellitus was excluded by repeated clinical and laboratory investigations. Forty two similar cases have been reported. Exact etiology for the development of non-diabetic glomerulosclerosis is unclear. But, hypertension, smoking, obesity, intermittent hyperglycemia predating the diagnosis of diabetes possibly explain the development of nodular glomerulosclerosis in these patients. Long-term follow-up to screen for the delayed onset of diabetes or its complications may be worthwhile.
Cocaine-induced acute renal failure has been reported in association with rhabdomyolysis. We desc... more Cocaine-induced acute renal failure has been reported in association with rhabdomyolysis. We describe a case of a young African American male who developed acute renal failure, which possibly occurred after inhalation of cocaine without concomitant rhabdomyolysis. His renal function recovered with supportive hydration. The most likely mechanism was intense vasoconstriction. Clinicians need to be mindful of this unique feature of cocaine intoxication.
MedGenMed : Medscape general medicine, Jan 14, 2004
A 74-year-old, white woman was admitted to the hospital for pleural effusion. Her medical history... more A 74-year-old, white woman was admitted to the hospital for pleural effusion. Her medical history included orthotopic cardiac transplantation, hypertension, hypercholesterolemia, peripheral vascular disease, diabetes mellitus, and renal insufficiency secondary to cyclosporine. She was on ...
Objectives: B-type natriuretic peptide (BNP) levels have been associated with sudden cardiac deat... more Objectives: B-type natriuretic peptide (BNP) levels have been associated with sudden cardiac death among patients with congestive heart failure (CHF). However, the relationship between BNP levels and arrhythmogenic substrates is poorly understood. We assessed whether there is a correlation between N-terminal pro-BNP levels (ProBNP) and device therapies in patients with CHF and defibrillators (ICD) or biventricular pacemakers-ICD (BiV-ICD). Methods: ProBNP levels were analyzed in 24 patients (19 men, age 64.2 Ϯ 12 years) with dilated cardiomyopathy (DCM), CHF, and ICD or BiV-ICD. Levels were studied among patients with and without device therapies. In patients with therapies, baseline ProBNP measurements were compared with the closest-to-therapy level. A two-tailed paired t test analyzed differences of mean ProBNP plasma levels. Results: Eighteen patients had ischemic and six nonischemic DCM; left ventricular ejection fraction. 25.1 Ϯ 6.1%. Twelve patients had BiV-ICD and 12 had ICD. Ten patients received therapies during a mean follow-up of 171 days: five appropriate therapies for VT/VF and five inappropriate therapies for atrial tachycardia. No change in the functional class of CHF preceded device therapies. There was no difference between baseline ProBNP levels in patients with therapies versus no therapies (therapies, 1800 Ϯ 1712 pg/mL; no therapies, 2587 Ϯ 2433 pg/mL; P value, 0.56). In the group with therapies, closest-totherapy ProBNP levels drawn within 3 days were higher than baseline levels in the limit of statistical significance (therapies, 3816.2 Ϯ 2842 pg/mL vs baseline, 1860.6 Ϯ 1398 pg/mL; P value, 0.05). Conclusions: In patients with CHF and defibrillation devices, baseline ProBNP levels were not different among patients that received device therapies as compared with patients without therapies. Closest-to-therapy ProBNP levels showed a trend to higher levels as compared with baseline. More severe left ventricular damage and greater hemodynamic derangement may account for higher proBNP levels in patients with device therapies. *This abstract was one of 25 selected for oral presentation in SMA's Physicians-in-Training Competition.
African Americans are over-represented in the endstage renal disease (ESRD) population in the Uni... more African Americans are over-represented in the endstage renal disease (ESRD) population in the United States secondary to the higher incidence of diabetes and hypertension (1). Their lower socioeconomic status and poor access to health care worsens this problem. The total number of renal transplantations done in the United States is increasing. Renal transplantation has improved the mortality, morbidity, and quality of life for patients with ESRD in comparison with patients continuing on dialysis (2). Similar to the disparities that exist in other medical procedures, African Americans with ESRD are less likely than whites to undergo renal transplantation despite being younger than whites (younger patients do better with transplantation) (3-5). Epidemiologic studies have shown that differences between whites and African Americans exist Navaneethan SD, Singh S. A systematic review of barriers in access to renal transplantation among African Americans in the United States.
Background: To identify patient and health system characteristics associated with late referral o... more Background: To identify patient and health system characteristics associated with late referral of patients with chronic kidney disease to nephrologists. Methods: MEDLINE, CENTRAL, and CINAHL were searched using the appropriate MESH terms in March 2007. Two reviewers individually and in duplicate reviewed the abstracts of 256 articles and selected 18 observational studies for inclusion. The reasons for late referral were categorized into patient or health system characteristics. Data extraction and content appraisal were done using a prespecified protocol. Results: Older age, the existence of multiple comorbidities, race other than Caucasian, lack of insurance, lower socioeconomic status and educational levels were patient characteristics associated with late referral of patients with chronic kidney disease. Lack of referring physician knowledge about the appropriate timing of referral, absence of communication between referring physicians and nephrologists, and dialysis care delivered at tertiary medical centers were health system characteristics associated with late referral of patients with chronic kidney disease. Most studies identified multiple factors associated with late referral, although the relative importance and the combined effect of these factors were not systematically evaluated. Conclusion: A combination of patient and health system characteristics is associated with late referral of patients with chronic kidney disease. Overall, being older, belonging to a minority group, being less educated, being uninsured, suffering from multiple comorbidities, and the lack of communication between primary care physicians and nephrologists contribute to late referral of patients with chronic kidney disease. Both primary care physicians and nephrologists need to engage in multisectoral collaborative efforts that ensure patient education and enhance physician awareness to improve the care of patients with chronic kidney disease. Background Chronic kidney disease is an emerging public health problem. A recent study reported that nearly 26 million Americans suffer from Chronic Kidney Disease (CKD) [1]. Future projections for the US population estimate more than 700,000 prevalent cases of End Stage Renal Disease (ESRD) by the year 2015 [2]. Observational studies and their meta-analysis have shown that late referral of
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