Longitudinal Changes in Liver Enzyme Levels Among Transgender People Receiving Gender Affirming Hormone Therapy.

BACKGROUND: The effect of gender affirming hormone therapy (GAHT) on clinical laboratory parameters, including levels of liver enzymes alanine aminotransferase (ALT) and aspartate transaminase (AST), is an area of uncertainty in transgender health. AIM: We sought to estimate the distribution parameters of liver enzyme levels among transmasculine (TM) and transfeminine (TF) persons receiving GAHT relative to the corresponding measures in cisgender reference groups, and to evaluate longitudinal changes in these laboratory measures following GAHT initiation. METHODS: The data for this longitudinal study included 624 TF and 438 transmasculine (TM) people as well as 4,090 cisgender males and 4,797 cisgender females enrolled in 3 integrated health systems. Time under observation was divided into 2 intervals: from the first blood test to the date of the first filled GAHT prescription and from GAHT initiation to the most recent ALT or AST measurement. Linear mixed models were used to compare changes in log-transformed ALT and AST values among transgender cohort members before and after GAHT initiation, and relative to the reference groups. The results were expressed as relative differences (in %) and the ratios of these differences (ratios-of-ratios) along with the 95% confidence intervals (CIs). OUTCOMES: Changes in ALT and AST levels among transgender people over time and relative to the corresponding changes in cisgender referents. RESULTS: Among TM study participants, the post GAHT ratios-of-ratios for AST were 1.61 (95% CI: 1.13, 2.31) and 1.57 (95% CI: 1.06, 2.31) relative to cisgender males and females respectively. For ALT, the corresponding comparisons yielded the ratios-of-ratios (95% CIs) of 2.06 (1.67, 2.54) and 1.90 (1.50, 2.40). No statistically significant changes were observed among TF participants. Other factors associated with higher liver enzyme levels included alcohol use/abuse and obesity. CLINICAL IMPLICATIONS: TM persons may experience modest increases in ALT and AST concentrations following testosterone initiation; however, clinical significance of the observed association remains unclear and requires further investigation. By contrast, feminizing GAHT is unlikely to induce appreciable changes in liver enzyme levels. STRENGTH AND LIMITATIONS: The strengths of this study are the longitudinal design and the ability to assemble an unselected cohort nested within large health systems. The main limitations include the lack of information on hormone levels and the inability to take into account GAHT doses and routes of administration. CONCLUSION: The influence of long-term GAHT on ALT and AST levels appears modest and not likely to reflect clinically meaningful changes in liver function. Hashemi L, Zhang Q, Getahun D, et al. Longitudinal Changes in Liver Enzyme Levels Among Transgender People Receiving Gender Affirming Hormone Therapy. J Sex Med 2021;18:1662-1675.

Changes in Size and Demographic Composition of Transgender and Gender Non-Binary Population Receiving Care at Integrated Health Systems.

OBJECTIVE: To examine temporal changes in the number and demographic composition of transgender/gender non-binary (TGNB) population using data from integrated health care systems. METHODS: Electronic health records from Kaiser Permanente health plans in Georgia and Northern and Southern California were used to identify TGNB individuals, who sought care from January 2006 to December 2014, and the data were analyzed by year, site, age, and sex assigned at birth. RESULTS: In 2006, the number of TGNB people (and corresponding 95% CI) per 100 000 population were 3.5 (1.9, 6.3) in Georgia, 5.5 (4.8, 6.4) in Southern California, and 17 (16, 19) in Northern California. In 2014, these frequencies increased to 38 (32, 45), 44 (42, 46), and 75 (72, 78) per 100 000 population, respectively. When analyzed by age, the most rapid increase was observed among persons 18 to 25 years old, and this increase accelerated after 2010. The ratio of transmasculine to transfeminine persons also changed from 1:1.7 in 2006 to 1:1 in 2014 overall and from 1:1 in 2006 to 1.8:1 in 2014 among persons <18 years of age. CONCLUSION: This analysis confirms previous observations that the proportion of TGNB people is growing, especially among young adults. The composition of the TGNB population is also changing from predominantly transfeminine to roughly 1:1 overall and to predominantly transmasculine in children and adolescents.

Visual Conformity With Affirmed Gender or "Passing": Its Distribution and Association With Depression and Anxiety in a Cohort of Transgender People.

BACKGROUND: Visual conformity with affirmed gender (VCAG) or "passing" is thought to be an important, but poorly understood, determinant of well-being in transgender people. VCAG is a subjective measure that is different from having an inner sense of being congruent with one's gender identity. AIM: We examined the frequency and determinants of VCAG and explored its association with mental health outcomes in a cohort of transgender adults. METHODS: The "Study of Transition, Outcomes & Gender (STRONG)" is a cohort of transgender individuals recruited from 3 Kaiser Permanente health plans located in Georgia, Northern California and Southern California. A subset of cohort members completed a survey between 2015 and 2017. VCAG was assessed as the difference between 2 scales: scale 1 reflecting the person's sense of how they are perceived by others, and scale 2 reflecting the person's desire to be perceived. Participants were considered to have achieved VCAG when their scale 1 scores were equal to or exceeded their scale 2 scores. The frequency of VCAG and their independent associations with anxiety and depression symptoms were explored using data from 620 survey respondents including 309 transwomen and 311 transmen. Based on self-described gender identity, none of the participants identified as nonbinary or gender fluid. OUTCOMES: VCAG, depression, and anxiety. RESULTS: VCAG was achieved in 28% of transwomen and 62% of transmen and was more common in persons who reported greater sense of acceptance and pride in their gender identity as measured on the Transgender Congruence Scale. Another factor associated with greater likelihood of VCAG was receipt of gender-affirming surgery, but the association was only evident among transmen. Participants who achieved VCAG had a lower likelihood of depression and anxiety with prevalence ratios (95% confidence intervals) of 0.79 (0.65, 0.96) and 0.67 (0.46, 0.98), respectively. CLINICAL IMPLICATIONS: VCAG may serve as an important outcome measure after gender-affirming therapy. STRENGTHS AND LIMITATIONS: Strengths of this study include a well-defined sampling frame and use of a novel patient-centered outcome of interest. Cross-sectional design and uncertain generalizability of results are the limitations. CONCLUSION: These results, once confirmed by prospective studies, may help better characterize the determinants of well-being in the transgender community, facilitating the design of interventions to improve the well-being and quality of life of this vulnerable population. To M, Zhang Q, Bradlyn A, et al. Visual Conformity With Affirmed Gender or "Passing": Its Distribution and Association With Depression and Anxiety in a Cohort of Transgender People. J Sex Med 2020;17:2084-2092.

Systematic Review for the 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Objective To review the literature systematically and perform meta-analyses to address these questions: 1) Is there evidence that self-measured blood pressure (BP) without other augmentation is superior to office-based measurement of BP for achieving better BP control or for preventing adverse clinical outcomes that are related to elevated BP? 2) What is the optimal target for BP lowering during antihypertensive therapy in adults? 3) In adults with hypertension, how do various antihypertensive drug classes differ in their benefits and harms compared with each other as first-line therapy? Methods Electronic literature searches were performed by Doctor Evidence, a global medical evidence software and services company, across PubMed and EMBASE from 1966 to 2015 using key words and relevant subject headings for randomized controlled trials that met eligibility criteria defined for each question. We performed analyses using traditional frequentist statistical and Bayesian approaches, including random-effects Bayesian network meta-analyses. Results Our results suggest that: 1) There is a modest but significant improvement in systolic BP in randomized controlled trials of self-measured BP versus usual care at 6 but not 12 months, and for selected patients and their providers self-measured BP may be a helpful adjunct to routine office care. 2) systolic BP lowering to a target of <130 mm Hg may reduce the risk of several important outcomes including risk of myocardial infarction, stroke, heart failure, and major cardiovascular events. No class of medications (ie, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers, or beta blockers) was significantly better than thiazides and thiazide-like diuretics as a first-line therapy for any outcome.

Delays in anti-hyperglycaemic therapy initiation and intensification are associated with cardiovascular events, hospitalizations for heart failure and all-cause mortality.

AIMS: The aims of this study were to assess the impact of delays in treatment intensification (TI) on cardiovascular events, heart failure, and all-cause mortality at typical stages of anti-hyperglycaemic therapy. MATERIALS AND METHODS: Using electronic health record data, we created three TI cohorts of diabetes patients who: 1) initiated metformin (MET) as their first anti-hyperglycaemic therapy; 2) added a sulfonylurea (SU) to MET; and 3) initiated insulin (INS) while using MET or SU, alone or in combination. Primary exposure variables were haemoglobin A1C value preceding cohort therapy (pre-TI A1C) and time to intensification, that is, the time between pre-TI A1C >7% and cohort index date. Cox regression models were used to analyse the associated risk of cardiovascular events, hospitalizations for heart failure and all-cause mortality. RESULTS: In the MET cohort, each additional percentage point of pre-TI A1C was associated with a 10% increased risk of a CV event (HR, 1.10; 95% CI, 1.03-1.07; P = 0.004), a 7% increased risk of HF hospitalization (HR, 1.07; 95% CI, 1.01-1.14; P = 0.034) and a 7% increased risk of all-cause mortality (HR, 1.07; 95% CI, 1.01-1.14; P = 0.032). Pre-TI A1C was associated with a 9% increased risk of a CV event in the INS cohort (HR,1.09; 95% CI, 1.04-1.13; P < 0.001). Each month of delay in TI was significantly associated with a 6% increased risk of hospitalization for HF (HR, 1.06; 95% CI, 1.00-1.13; P = 0.040) and all-cause mortality (HR, 1.06; 95% CI, 1.00-1.13; P = 0.050) in the MET cohort. CONCLUSIONS: Delays in TI were associated with poor outcomes over a mean follow-up period of nearly five years. Earlier initiation and more rapid intensification of pharmacotherapy could reduce the risk of poor outcomes.

Agreement between medical records and self-reports: Implications for transgender health research.

A key priority of transgender health research is the evaluation of long-term effects of gender affirmation treatment. Thus, accurate assessment of treatment receipt is critical. The data for this analysis came from an electronic medical records (EMR) based cohort of transgender individuals. A subset of cohort members were also asked to complete a self-administered survey. Information from the EMR was compared with survey responses to assess the extent of agreement regarding transmasculine (TM)/transfeminine (TF) status, hormone therapy receipt, and type of surgery performed. Logistic regression models were used to assess whether participant characteristics were associated with disagreement between data sources. Agreement between EMR and survey-derived information was high regarding TM/TF status (99%) and hormone therapy receipt (97%). Lower agreement was observed for chest reconstruction surgery (72%) and genital reconstruction surgery (84%). Using survey responses as the "gold standard", both chest and genital reconstruction surgeries had high specificity (95 and 93%, respectively), but the corresponding sensitivities were low (49 and 68%, respectively). A lower proportion of TM had concordant results for chest reconstruction surgery (64% versus 79% for TF) while genital reconstruction surgery concordance was lower among TF (79% versus 89% for TM). For both surgery types, agreement was highest among the youngest participants. Our findings offer assurance that EMR-based data appropriately classify cohort participants with respect to their TM/TF status or hormone therapy receipt. However, current EMR data may not capture the complete history of gender affirmation surgeries. This information is useful in future studies of outcomes related to gender affirming therapy.

Improving Adherence to Cardiovascular Therapies: An Economic Evaluation of a Randomized Pragmatic Trial.

OBJECTIVE: Preplanned economic analysis of a pragmatic trial using electronic-medical-record-linked interactive voice recognition (IVR) reminders for enhancing adherence to cardiovascular medications (i.e., statins, angiotensin-converting enzyme inhibitors [ACEIs], and angiotensin receptor blockers [ARBs]). METHODS: Three groups, usual care (UC), IVR, and IVR plus educational materials (IVR+), with 21,752 suboptimally adherent patients underwent follow-up for 9.6 months on average. Costs to implement and deliver the intervention (from a payer perspective) were tracked during the trial. Medical care costs and outcomes were ascertained using electronic medical records. RESULTS: Per-patient intervention costs ranged from $9 to $17 for IVR and from $36 to $47 for IVR+. For ACEI/ARB, the incremental cost-effectiveness ratio for each percent adherence increase was about 3 times higher with IVR+ than with IVR ($6 and $16 for IVR and IVR+, respectively). For statins, the incremental cost-effectiveness ratio for each percent adherence increase was about 7 times higher with IVR+ than with IVR ($6 and $43 for IVR and IVR+, respectively). Considering potential cost offsets from reduced cardiovascular events, the probability of breakeven was the highest for UC, but the IVR-based interventions had a higher probability of breakeven for subgroups with a baseline low-density lipoprotein (LDL) level of more than 100 mg/dl and those with two or more calls. CONCLUSIONS: We found that the use of an automated voice messaging system to promote adherence to ACEIs/ARBs and statins may be cost-effective, depending on a decision maker's willingness to pay for unit increase in adherence. When considering changes in LDL level and downstream medical care offsets, UC is the optimal strategy for the general population. However, IVR-based interventions may be the optimal choice for those with elevated LDL values at baseline.

Association of Housing Instability with Obesity Status Among Insured Adults.

INTRODUCTION: Obesity affects four in ten US adults. One of the most prevalent health-related social risk factors in the US is housing instability, which is also associated with cardiovascular health outcomes, including obesity. The objective of this research brief is to examine the association between housing instability with obesity status among a representative sample of insured adults across seven integrated health systems. METHODS: Kaiser Permanente National Social Needs Survey used a multistage stratified sampling framework to administer a cross-sectional survey across seven integrated health systems (administered Jan.-Sept. 2020). Survey data were linked with electronic health records (EHR). Housing instability was categorized into levels of risk: (1) "No Risk"; (2) "Moderate Risk"; and (3) "Severe Risk." Based on established BMI thresholds, obesity, and severe obesity served as the primary outcome variables. In 2023, weighted multivariable logistic regression accounted for the complex sampling design and response probability and controlled for covariates. RESULTS: The analytic cohort comprised 6,397 adults. Unadjusted weighted prevalence of obesity and severe obesity was 31.1% and 5.3%, respectively; and 15.5% reported housing instability. Adjusted regression models showed that the odds of severe obesity was nearly double among adults exposed to severe housing instability (Adjusted OR=1.93; 95% CI 1.14-3.26). Other BMI categories were not associated with housing instability. CONCLUSIONS: Among a representative cohort of insured adults, this study suggested increasing levels of housing instability are associated with increasing levels of obesity. Future research should further explore the temporal, longitudinal, and independent association of housing instability with obesity.

Association between gender-affirming hormone therapy and measures of glucose metabolism: A longitudinal study.

CONTEXT: The long-term effect of gender-affirming hormone therapy (GAHT) on glucose metabolism is an area of priority in transgender health research. OBJECTIVES: To evaluate the relation between GAHT and changes in fasting blood glucose (FG) and glycosylated hemoglobin (HbA1c) in transmasculine (TM) and transfeminine (TF) persons relative to the corresponding temporal changes in presumably cisgender persons (i.e. without any evidence of TGD status). DESIGN: Retrospective cohort study. SETTING: Three large integrated health systems. PARTICIPANTS: 2,425 TF and 2,127 TM persons compared with 33,995 cisgender males (CM) and 38,913 cisgender females (CF) enrolled in the same health plans. OUTCOMES/MEASURES: Temporal changes in FG and HbA1c levels examined using linear mixed models with main results expressed as ratios-of-ratios. RESULTS: The pre- versus post-GAHT ratios-of-ratio (95% confidence interval) estimates adjusted for age, race/ethnicity, study site, and body mass index in the model comparing TF and CM groups were 1.05 (1.01, 1.09) for FG and 1.03 (0.99, 1.06) for HbA1c. By contrast, the corresponding results in the models contrasting TM and cisgender cohort members were in the 0.99-1.00 range. The ratio-of-ratios comparing post-GAHT changes among transgender and cisgender persons were close to the null and without a discernable pattern. CONCLUSION: Though the within-transgender cohort data suggest an increase in the levels of FG and HbA1c following feminizing GAHT initiation, these changes were no longer evident when compared with the corresponding changes in cisgender referents. Based on these results, clinically important effects of GAHT on routine laboratory markers of glucose metabolism appear unlikely.

Initial antiretroviral therapy regimen and risk of heart failure.

OBJECTIVES: Heart failure risk is elevated in people with HIV (PWH). We investigated whether initial antiretroviral therapy (ART) regimens influenced heart failure risk. DESIGN: Cohort study. METHODS: PWH who initiated an ART regimen between 2000 and 2016 were identified from three integrated healthcare systems. We evaluated heart failure risk by protease inhibitor, nonnucleoside reverse transcriptase inhibitors (NNRTI), and integrase strand transfer inhibitor (INSTI)-based ART, and comparing two common nucleotide reverse transcriptase inhibitors: tenofovir disoproxil fumarate (tenofovir) and abacavir. Follow-up for each pairwise comparison varied (i.e. 7 years for protease inhibitor vs. NNRTI; 5 years for tenofovir vs. abacavir; 2 years for INSTIs vs. PIs or NNRTIs). Hazard ratios were from working logistic marginal structural models, fitted with inverse probability weighting to adjust for demographics, and traditional cardiovascular risk factors. RESULTS: Thirteen thousand six hundred and thirty-four PWH were included (88% men, median 40 years of age; 34% non-Hispanic white, 24% non-Hispanic black, and 24% Hispanic). The hazard ratio (95% CI) were: 2.5 (1.5-4.3) for protease inhibitor vs. NNRTI-based ART (reference); 0.5 (0.2-1.8) for protease inhibitor vs. INSTI-based ART (reference); 0.1 (0.1-0.8) for NNRTI vs. INSTI-based ART (reference); and 1.7 (0.5-5.7) for tenofovir vs. abacavir (reference). In more complex models of cumulative incidence that accounted for possible nonproportional hazards over time, the only remaining finding was evidence of a higher risk of heart failure for protease inhibitor compared with NNRTI-based regimens (1.8 vs. 0.8%; P  = 0.002). CONCLUSION: PWH initiating protease inhibitors may be at higher risk of heart failure compared with those initiating NNRTIs. Future studies with longer follow-up with INSTI-based and other specific ART are warranted.

Geographic variation in cardiovascular procedure use among Medicare fee-for-service vs Medicare Advantage beneficiaries.

IMPORTANCE: Little is known about how different financial incentives between Medicare Advantage and Medicare fee-for-service (FFS) reimbursement structures influence use of cardiovascular procedures. OBJECTIVE: To compare regional cardiovascular procedure rates between Medicare Advantage and Medicare FFS beneficiaries. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional study of Medicare beneficiaries older than 65 years between 2003-2007 comparing rates of coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG) surgery across 32 hospital referral regions in 12 states. MAIN OUTCOMES AND MEASURES: Rates of coronary angiography, PCI, and CABG surgery. RESULTS: We evaluated a total of 878,339 Medicare Advantage patients and 5,013,650 Medicare FFS patients. Compared with Medicare FFS patients, Medicare Advantage patients had lower age-, sex-, race-, and income-adjusted procedure rates per 1000 person-years for angiography (16.5 [95% CI, 14.8-18.2] vs 25.9 [95% CI, 24.0-27.9]; P < .001) and PCI (6.8 [95% CI, 6.0-7.6] vs 9.8 [95% CI, 9.0-10.6]; P < .001) but similar rates for CABG surgery (3.1 [95% CI, 2.8-3.5] vs 3.4 [95% CI, 3.1-3.7]; P = .33). There were no significant differences between Medicare Advantage and Medicare FFS patients in the rates per 1000 person-years of urgent angiography (3.9 [95% CI, 3.6-4.2] vs 4.3 [95% CI, 4.0-4.6]; P = .24) or PCI (2.4 [95% CI, 2.2-2.7] vs 2.7 [95% CI, 2.5-2.9]; P = .16). Procedure rates varied widely across hospital referral regions among Medicare Advantage and Medicare FFS patients. For angiography, the rates per 1000 person-years ranged from 9.8 to 40.6 for Medicare Advantage beneficiaries and from 15.7 to 44.3 for Medicare FFS beneficiaries. For PCI, the rates ranged from 3.5 to 16.8 for Medicare Advantage and from 4.7 to 16.1 for Medicare FFS. The rates for CABG surgery ranged from 1.5 to 6.1 for Medicare Advantage and from 2.5 to 6.0 for Medicare FFS. Across regions, we found no statistically significant correlation between Medicare Advantage and Medicare FFS beneficiary utilization for angiography (Spearman r = 0.19, P = .29) and modest correlations for PCI (Spearman r = 0.33, P = .06) and CABG surgery (Spearman r = 0.35, P = .05). Among Medicare Advantage beneficiaries, adjustment for additional cardiac risk factors had little influence on procedure rates. CONCLUSIONS AND RELEVANCE: Although Medicare beneficiaries enrolled in capitated Medicare Advantage programs had lower angiography and PCI procedure rates than those enrolled in Medicare FFS, the degree of geographic variation in procedure rates was substantial among Medicare Advantage beneficiaries and was similar in magnitude to that observed among Medicare FFS beneficiaries.

Prevalence of self-inflicted injuries among transgender and gender diverse adolescents and young adults compared to their peers: an examination of interaction with mental health morbidity.

PURPOSE: Compare occurrence of self-inflicted injuries among transgender and gender diverse (TGD) youth to that of their cisgender peers while accounting for mental health diagnoses. METHODS: Review of electronic health records from three integrated health care systems identified 1087 transfeminine and 1431 transmasculine adolescents and young adults. Poisson regression was used to calculate prevalence ratios comparing the proportion of TGD participants with at least one self-inflicted injury (a surrogate for suicide attempt) before index date (first evidence of TGD status) to the corresponding proportions in presumed cisgender male and female referents matched on age, race/ethnicity, and health plan. Interactions between gender identities and mental health diagnoses were assessed on multiplicative and additive scales. RESULTS: TGD adolescents and young adults were more likely to have a self-inflicted injury, various mental health diagnoses, and multiple mental health diagnoses than their cisgender peers. The prevalence of self-inflicted injuries among TGD adolescents and young adults was high even in the absence of mental health diagnoses. Results were consistent with positive additive interaction and negative multiplicative interaction. CONCLUSIONS: Universal suicide prevention efforts for all youth, including those with no mental health diagnoses, and more intensive suicide prevention efforts for TGD adolescents and young adults and those with at least one mental health diagnosis are warranted.

Patient Pill Organization Strategies and Adherence Measured in a Cross-Sectional Study of Hypertension.

Background: The strategies patients use to organize medications (eg, pill dispenser) may be reflected in adherence measured at follow-up. We studied whether medication organization strategies patients use at home are associated with adherence measured using pharmacy-fills, self-report, and pill counts. Design: Secondary analysis of data from a prospective randomized clinical trial. Setting: Eleven US safety-net and community primary care clinics. Patients: Of the 960 enrolled self-identified non-Hispanic Black and White patients prescribed antihypertensive medications, 731 patients reported pill organization strategies and were included. Variable: Patients were asked if they use any of the following medication organization strategies: finish previous refills first; use a pill dispenser; combine same prescriptions; or combine dissimilar prescriptions. Outcomes: Adherence to antihypertensive medications using pill counts (range, 0.0-1.0% of the days covered), pharmacy-fill (proportion of days covered >90%), and self-report (adherent/non-adherent). Results: Of the 731 participants, 38.3% were men, 51.7% were age ≥65, 52.9% self-identified as Black or African American. Of the strategies studied, 51.7% finished previous refills first, 46.5% used a pill dispenser, 38.2% combined same prescriptions and 6.0% combined dissimilar prescriptions. Median (IQR) pill count adherence was 0.65 (0.40-0.87), pharmacy-fill adherence was 75.7%, and self-reported adherence was 63.2%. Those who combined same prescriptions had significantly lower measured pill count adherence than those who did not (0.56 (0.26-0.82) vs 0.70 (0.46-0.90), p<0.01) with no significant difference in pharmacy-fill (78.1% vs 74%, p=0.22) or self-reported adherence (63.0% vs 63.3%, p=0.93). Conclusion: Self-reported medication organization strategies were common. Combining same prescriptions was associated with lower adherence as measured using pill counts but not pharmacy-fills or self-report. Clinicians and researchers should identify the pill organization strategies used by their patients to understand how these strategies may influence measures of patient adherence. Trial Registration: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB).

Clinician's use of automated reports of estimated glomerular filtration rate: a qualitative study.

BACKGROUND: There is a growing awareness in primary care of the importance of identifying patients with chronic kidney disease (CKD) so that they can receive appropriate clinical care; one method that has been widely embraced is the use of automated reporting of estimated glomerular filtration rate (eGFR) by clinical laboratories. We undertook a qualitative study to examine how clinicians use eGFR in clinical decision making, patient communication issues, barriers to use of eGFR, and suggestions to improve the clinical usefulness of eGFR reports. METHODS: Our study used qualitative methods with structured interviews among primary care clinicians including both physicians and allied health providers, recruited from Kaiser Permanente Northwest, a non-profit health maintenance organization. RESULTS: We found that clinicians generally held favorable views toward eGFR reporting but did not use eGFR to replace serum creatinine in their clinical decision-making. Clinicians used eGFR as a tool to help identify CKD, educate patients about their kidney function and make treatment decisions. Barriers noted by several clinicians included a desire for greater education regarding care for patients with CKD and tools to facilitate discussion of eGFR findings with patients. CONCLUSIONS: The manner in which clinicians use eGFRs appears to be more complex than previously understood, and our study illustrates some of the efforts that might be usefully undertaken (e.g. specific clinician education) when encouraging further promulgation of eGFR reporting and usage.

Proteinuria among patients with chronic kidney disease: a performance measure for improving patient outcomes.

BACKGROUND: In an effort to improve identification and treatment of patients with chronic kidney disease (CKD), the National Kidney Foundation (NKF) developed the Kidney Disease Quality Outcomes Initiative (KDQOI) clinical practice guidelines, which include measurement of proteinuria among all patients with CKD who are not receiving chronic dialysis therapy. Encouraging dissemination and utilization of these guidelines may be enhanced by the development of performance measures. The question of whether adequate evidence exists to advocate for the measurement of proteinuria in CKD as a performance measure was explored. METHODS: The US Preventive Services Task Force "chain of evidence" framework was used to guide evidence synthesis from the systematic review. Five questions were applied to specific links in the evidence chain: (1) Is there direct evidence that testing for proteinuria improves health outcomes? (2) What is the yield of testing, in terms of both accuracy and reliability of the test and the prevalence of undiagnosed proteinuria? (3) What adverse effects result from testing a person for proteinuria? (4) Does treatment of proteinuria as a result of testing provide an incremental benefit in health outcomes? and (5) What adverse effects result from treating a person for proteinuria? The systematic search specifically targeted meta-analyses and systematic reviews. FINDINGS: The systematic review revealed no direct evidence that testing for proteinuria among patients with CKD reduced incidence of end-stage renal disease (ESRD). However, the strong links between testing, treatment, and outcome suggest a correlation between proteinuria testing and ESRD. CONCLUSIONS: Current evidence suggests that proteinuria testing (using the albumin-to-creatinine ratio [ACR]) among patients with CKD would be an appropriate health care quality performance measure for improving patient outcomes.

Construction of a multisite DataLink using electronic health records for the identification, surveillance, prevention, and management of diabetes mellitus: the SUPREME-DM project.

INTRODUCTION: Electronic health record (EHR) data enhance opportunities for conducting surveillance of diabetes. The objective of this study was to identify the number of people with diabetes from a diabetes DataLink developed as part of the SUPREME-DM (SUrveillance, PREvention, and ManagEment of Diabetes Mellitus) project, a consortium of 11 integrated health systems that use comprehensive EHR data for research. METHODS: We identified all members of 11 health care systems who had any enrollment from January 2005 through December 2009. For these members, we searched inpatient and outpatient diagnosis codes, laboratory test results, and pharmaceutical dispensings from January 2000 through December 2009 to create indicator variables that could potentially identify a person with diabetes. Using this information, we estimated the number of people with diabetes and among them, the number of incident cases, defined as indication of diabetes after at least 2 years of continuous health system enrollment. RESULTS: The 11 health systems contributed 15,765,529 unique members, of whom 1,085,947 (6.9%) met 1 or more study criteria for diabetes. The nonstandardized proportion meeting study criteria for diabetes ranged from 4.2% to 12.4% across sites. Most members with diabetes (88%) met multiple criteria. Of the members with diabetes, 428,349 (39.4%) were incident cases. CONCLUSION: The SUPREME-DM DataLink is a unique resource that provides an opportunity to conduct comparative effectiveness research, epidemiologic surveillance including longitudinal analyses, and population-based care management studies of people with diabetes. It also provides a useful data source for pragmatic clinical trials of prevention or treatment interventions.

Occupational silica exposure and chronic kidney disease.

INTRODUCTION: Occupational exposure to silica may be associated with chronic kidney disease (CKD). Most studies have been conducted in occupational cohorts with high levels of exposure but small numbers of cases. We analyzed data from a population-based case-control study of occupational silica exposure and CKD. METHODS: Cases were hospital patients with newly diagnosed CKD, and community controls were selected using random digit dialing and frequency matched by age, gender, race, and proximity to the hospital. Silica exposure estimates were assigned by industrial hygiene review of lifetime job history data and weighted for certainty and intensity. Conditional logistic regression was used to estimate the odds ratios (ORs) for CKD conditioned on demographic, lifestyle, and clinical variables. RESULTS: The mean age of participants was 63 years (range 30-83 years); 59% were male and 55% were white. Any silica exposure (compared with none) was associated with a 40% increased risk of CKD [OR = 1.40, 95% confidence interval (CI): 1.04, 1.89] in a multivariable adjusted model. The mean cumulative duration of silica exposure was significantly higher in exposed cases than in exposed controls (33.4 vs. 24.8 years, respectively). Overall, compared with nonexposed participants, the ORs (95% CI) for those below and above the median duration of silica exposure were 1.20 (0.77, 1.86) and 1.76 (1.14, 2.71), respectively. CONCLUSIONS: We found a positive relationship between occupational silica exposure and CKD. A dose-response trend of increasing CKD risk with increasing duration of silica exposure was observed and was particularly strong among nonwhites.

Early Referral, Living Donation, and Preemptive Kidney Transplant.

BACKGROUND: Preemptive kidney transplant (PKT) is recognized as the most beneficial and cost-effective form of renal replacement therapy among patients with end-stage renal disease. Despite optimal outcomes and improved quality of life associated with PKT, its use as a first renal replacement therapy remains low among patients with end-stage renal disease. The goal of this retrospective cohort study was to compare, among adult kidney transplant recipients, characteristics across PKT status. METHODS: We compared the characteristics of patients who did and did not have a PKT over 5 years, from 2010 to 2014, using the electronic health records of Kaiser Permanente Mid-Atlantic States. RESULTS: A total of 233 patients received a kidney-alone transplant, and, of these, 44 patients (19%) were PKT and 189 patients (81%) were non-PKT. Of the patients in the PKT group, 43% received a kidney from a deceased donor. PKT recipients were more often White, had polycystic kidney disease or glomerulonephritis, received a living donor organ, and were transplanted at certain transplant centers. Estimated glomerular filtration rate on listing for those who received a deceased donor transplant was higher in PKT than non-PKT patients listed pre-dialysis. CONCLUSIONS: PKT was associated with having a living kidney donor and with having a higher estimated glomerular filtration rate at listing for deceased donor recipients.

Health Behavior Theory and Hypertension Management: Comparisons Among Black, White, and American Indian and Alaska Native Patients.

In the United States, hypertension is more common among individuals from racial and ethnic minority groups. Hypertension control rates are also lower for minority group members compared with White Americans. However, little research has employed well-established theoretical perspectives on health behavior, such as the Theory of Planned Behavior (TPB) and the Model of Goal-Directed Behavior (MGB), to better understand racial differences in rates of hypertension control. The present study examines the psychological processes involved in efforts to control blood pressure, through the lens of the TPB augmented by the MGB, in hypertensive patients of three racial groups: American Indian/Alaska Native, Black/African American, and White. Participants completed measures of past efforts to control blood pressure, attitudes, norms, perceived behavioral control, intentions, and anticipated emotions. Analyses employed confirmatory factor analysis and cross-groups path analysis. Measurement of the theoretical constructs and core putative mediators of blood pressure control intentions were largely similar across racial groups. With regard to the patterns of relationships among the constructs, differences among the groups were most apparent in pathways from past efforts to both cognitive and affective theoretical antecedents of intentions. These findings contribute to the sparse literature on factors involved in racial differences in hypertension control rates and may inform future interventions aimed at increasing hypertension control behaviors. Trial Registration ClinicalTrials.gov, NCT03028597, registered 23 January 2017, https://clinicaltrials.gov/ct2/show/NCT03028597; ClinicalTrials.gov, NCT04414982, registered 4 June 2020 (retrospectively registered), https://www.clinicaltrials.gov/ct2/show/NCT04414982.