Trends in Prevalence and Treatment of Diabetic Macular Edema and Vision-Threatening Diabetic Retinopathy Among Medicare Part B Fee-for-Service Beneficiaries.

IMPORTANCE: While diabetes prevalence among US adults has increased in recent decades, few studies document trends in diabetes-related eye disease. OBJECTIVE: To examine 10-year trends (2009-2018) in annual prevalence of Medicare beneficiaries with diabetes with a diagnosis of diabetic macular edema (DME) or vision-threatening diabetic retinopathy (VTDR) and trends in treatment. DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study using Centers for Medicare & Medicaid Services research identifiable files, data for patients 65 years and older were analyzed from claims. Beneficiaries were continuously enrolled in Medicare Part B fee-for-service (FFS) insurance for the calendar year and had a diagnosis of diabetes on 1 or more inpatient claims or 2 or more outpatient claims during the calendar year or a 1-year look-back period. MAIN OUTCOMES AND MEASURES: Using diagnosis and procedure codes, annual prevalence was determined for beneficiaries with 1 or more claims for (1) any DME, (2) either DME or VTDR, and (3) anti-vascular endothelial growth factor (VEGF) injections, laser photocoagulation, or vitrectomy, stratified by any DME, VTDR with DME, and VTDR without DME. Racial and ethnic disparities in diagnosis and treatment are presented for 2018. RESULTS: In 2018, 6 960 823 beneficiaries (27.4%) had diabetes; half were aged 65 to 74 years (49.7%), half (52.7%) were women, and 75.7% were non-Hispanic White. From 2009 to 2018, there was an increase in the annual prevalence of beneficiaries with diabetes who had 1 or more claims for any DME (1.0% to 3.3%) and DME/VTDR (2.8% to 4.3%). Annual prevalence of anti-VEGF increased, particularly among patients with any DME (15.7% to 35.2%) or VTDR with DME (20.2% to 47.6%). Annual prevalence of laser photocoagulation decreased among those with any DME (45.5% to 12.5%), VTDR with DME (54.0% to 20.3%), and VTDR without DME (22.5% to 5.8%). Among all 3 groups, prevalence of vitrectomy in 2018 was less than half that in 2009. Prevalence of any DME and DME/VTDR was highest among Hispanic beneficiaries (5.0% and 7.0%, respectively) and Black beneficiaries (4.5% and 6.2%, respectively) and lowest among non-Hispanic White beneficiaries (3.0% and 3.8%, respectively). Among those with DME/VTDR, anti-VEGF was most prevalent among non-Hispanic White beneficiaries (30.3%). CONCLUSIONS AND RELEVANCE: From 2009 to 2018, prevalence of DME or VTDR increased among Medicare Part B FFS beneficiaries alongside an increase in anti-VEGF treatment and a decline in laser photocoagulation and vitrectomy.

The Prevalence of Diagnosis of Major Eye Diseases and their Associated Payments in the Medicare Fee-for-Service Program.

PURPOSE: To estimate the prevalence of diagnosis of major eye disorders and their associated payments, in total and per-person diagnosed, among Medicare fee-for-service (FFS) beneficiaries in 2018. METHODS: We analyzed 100% Medicare Part B FFS claims and Part D Events among beneficiaries continuously enrolled for 12 months in 2018 to calculate the proportion of beneficiaries with ≥1 claim indicating age-related macular degeneration (AMD), cataract, diabetic retinopathy (DR), or glaucoma, and their associated payments, including Medicare and patient out-of-pocket. Eye disease and eye care services were identified using case definitions from the Centers for Disease Control and Prevention's (CDC) Vision & Eye Health Surveillance System (VEHSS). Outcomes are reported by disease overall and by age group (0-39, 40-64, 65-84, 85+ years), sex, race/ethnicity, and U.S. state. RESULTS: Among nearly 30 million Medicare Part B FFS beneficiaries in 2018, over 41% (12.4 million) had a claim containing a diagnosis of at least one of the four eye disorders; 33.7% with cataract, 13.3% with glaucoma, 9.2% with AMD and 3.2% with DR. Payments for eye care services and drugs associated with these four conditions were $10.1billion; $3.6 billion for cataract, $3.5 billion for AMD, $2.2 billion for glaucoma and $0.8 billion for DR. The average cost per beneficiary diagnosed was $816: $1,290 for AMD, $781 for DR, $543 for glaucoma, and $360 for cataract. CONCLUSIONS: Major eye disorders are common among Medicare FFS beneficiaries and account for approximately 4.3% of Medicare Part B and 1% of Medicare Part D spending.

Metformin decreases testicular damages following ischaemia/reperfusion injury in rats.

The effects of metformin on a testicular torsion injury in adolescent rat testis after I/R were evaluated in the present study. Forty adolescent rats were divided into five groups with eight rats per group: a control group; a sham-operated group; an ischaemia group, where torsion was applied for 4 hr and testis was examined immediately after detorsion; an I/R group, where torsion was applied for 4 hr and the testis was examined 4 hr after detorsion; and an I/R + M group, where the metformin (300 mg/kg) administration was added to the identical procedures used for the I/R group. Spermatogenesis, basal membrane integrity and cleaved caspase-3 expression were assessed. The I/R + M group had a significantly higher Johnsen score than the I/R group (7.9 ± 0.1 vs. 7.5 ± 0.2; p < .001; F-value = 14.2). Failure of basal membrane integrity was highest in the ischaemia group (45 ± 5) compared to the other groups (control group, 20 ± 5; sham-operated group, 16.6 ± 2.8), but not different between the I/R + M (31.6 ± 12.5) and the I/R groups (25 ± 3.5). Cleaved caspase-3 expression was highest in the ischaemia group (73.5 ± 0.7), and significantly lower in the I/R + M group (33.4 ± 0.9) than the I/R group (58.5 ± 0.2; p < .05; F-value = 7.6). Metformin decreases testicular damage by exerting protection against the harmful effects of I/R on spermatogenesis and alleviating apoptosis in adolescent rat testis.

Results of intracytoplasmic sperm injection performed with sperm retrieved by microscopic testicular sperm extraction in azoospermic patients.

OBJECTIVE: The absence of any sperm in the ejaculate is called azoospermia and it is detected in 1% of males and 10-15% of those with infertility complaints. Azoospermia may be due to obstructive (OA) and non-obstructive (NOA) causes. Today, healthy pregnancies can be achieved in azoospermic patients by intracytoplasmic sperm injection (ICSI) performed using sperm retrieved from microscopic testicular sperm extraction (m-TESE). In this study, we examined the sperm retrieval rates with m-TESE in azoospermic patients, the results of ICSI in OA and NOA patients with sperm and the underlying testicular pathologies in patients without sperm. MATERIAL AND METHODS: Patients who underwent m-TESE at IVF unit of our hospital between January 2005 and April 2017 were retrospectively reviewed. A total of 342 azoospermic patients (117 OA and 225 NOA cases) with regular follow-up were included in the study. In these cases, sperm retrieval and clinical pregnancy rates after ICSI were compared. RESULTS: In the m-TESE procedure, motile sperm was found in all of the OA patients and in 52.4% (118/225) of the NOA patients. Clinical pregnancy rate in the OA group was 29.9% (35/117) and live birth rate was 25.6% (30/117). In the NOA group, the clinical pregnancy rate was 27.1% (32/118) and the live birth rate was 23.7% (27/118). Histopathologic evaluation was made in 107 cases in the NOA group with no testicular sperm, revealing that 59 cases with germ-cell aplasia (sertoli-cell only syndrome), 42 cases with maturation arrest, and 6 cases with hypospermatogenesis. Postoperative hematoma developed in 3 of m-TESE cases and subsided with conservative treatment. CONCLUSION: If motile sperm is retrieved with m-TESE application in azoospermic patients, pregnancy resulting in one live birth in about 4 couples who undergo ICSI application can be achieved. In the presence of motile sperm, live birth rates are similar between OA and NOA case with very low complication rates.

Health Indicators for Older Sexual Minorities: National Health Interview Survey, 2013-2014.

PURPOSE: Advances in lesbian, gay, and bisexual (sexual minority [SM]) acceptance and equality have been made in the past decade. However, certain SM subgroups continue to be disadvantaged due to lack of data and, thus, lack of knowledge about these populations. Data for older sexual minorities are especially lacking and will be increasingly important as more sexual minorities enter older age. This research explores results from a nationally representative health survey to elucidate some health indicators for older sexual minorities. METHODS: Data from the 2013 and 2014 National Health Interview Surveys (NHIS) were pooled for increased sample size, and established research methods were followed as recommended by prior NHIS sexual orientation studies. We conducted descriptive analyses on the differences between SM and heterosexual groups, aged 65 years and older, for 12 health indicators. RESULTS: Four out of the 12 health indicators were significantly different for sexual minorities, and three out of those four indicated positive health outcomes or behaviors when compared with heterosexuals. Sexual minorities were more than three times as likely to receive HIV testing as heterosexual peers. Sexual minorities were more likely to receive an influenza vaccination, and much more likely to report excellent or very good health, than their heterosexual peers. Sexual minorities were more than twice as likely to report binge drinking, which is consistent with prior research for adult sexual minorities. CONCLUSION: This analysis is the first to examine national data on health indicators for sexual minorities, aged 65 years and older, using NHIS data. As more surveys begin to collect SMdata and more years of data are collected by NHIS, a clearer picture of the health of older adult sexual minorities should emerge.

Osteogenesis imperfecta Type IV: a newly identified variant at position c.560 (G > T; p.Gly187Val) in the COL1A2 gene.

Osteogenesis imperfecta is a clinically heterogenous disease caused by defective collagen syntesis associated with a mutation in the COL1A1 or COL1A2 genes. In this report, we present a case of osteogenesis imperfecta (OI) type IV, seen in a female fetus with incurved femurs at 18 weeks of gestation. Molecular analysis of the newborn revealed a novel mutation at position c.560 (c.560 G > T) of the exon 12 in the COL1A2 gene; which lead to the glycine modification with valine (p.Gly187Val) at codon 187. The pregnancy follow-up was uneventful. After delivery, the newborn underwent biphosponat therapy and no fracture was detected until 1 year old.

Gonadotropin-releasing hormone agonist triggering with concomitant administration of low doses of human chorionic gonadotropin or a freeze-all strategy in high responders.

OBJECTIVES: To compare the live birth rates and moderate/severe ovarian hyperstimulation syndrome (OHSS) rates of 2 different approaches using gonadotropin-releasing hormone (GnRH) agonist triggering in high responder women. Methods: A retrospective cohort study was performed to evaluate intracytoplasmic sperm injection (ICSI) and embryo transfer (ET) outcomes in high responder women who underwent ovulation induction with a GnRH antagonist protocol between April 2011 and March 2015. In group 1 (n=74), GnRH agonist was used for ovulation triggering with the concomitant use of 1500 IU of urinary human chorionic gonadotropin (hCG) immediately after oocyte retrieval followed by fresh ET and standard luteal support. In group 2 (n=48), GnRH agonist was used for triggering after freezing all embryos and subsequent frozen/thawed embryo transfer (FET); this approach is considered the "freeze-all" approach. Results: Baseline characteristics were similar between the groups. The clinical pregnancy rates for group 1 was 45.9% and group 2 was 43.8% (p=0.812, chi-squared test) and live birth rates for group 1 was 40.5% and for group 2 41.7% (p=0.902, chi-squared test) were comparable between groups. In group 1, late-onset OHSS was observed (one severe case and one moderate case) in 2 patients (2.7%). In group 2, none of the patients experienced moderate/severe OHSS. Conclusion: The live birth rate with GnRH agonist triggering and concomitant use of 1500 IU of hCG immediately after oocyte retrieval was similar to that obtained with the freeze-all approach and FET in a subsequent cycle. The administration of a low dose of hCG in GnRH agonist trigger cycles caused moderate/severe OHSS in 2.7% of the patients.

A retrospective analysis of nebulized versus intravenous fentanyl for renal colic.

STUDY OBJECTIVE: To assess the effectiveness of nebulized fentanyl used for analgesia in renal colic. MATERIALS/METHODS: This research was planned as a randomized, blinded study in which prospectively collected data were analyzed retrospectively to compare nebulized and intravenous (iv) fentanyl therapies. Patients with renal colic with 'moderate' or worse pain on a four-point verbal pain score (VPS) or with pain of 20mm or above on a 100-mm visual analogue score (VAS) at time of presentation were randomized into iv fentanyl (n=62) or nebulized fentanyl (n=53) study groups. Decreases in VAS and VPS scores at 15 and 30min compared to baseline, rescue analgesia requirements and side-effects between the groups were compared. RESULTS: Both iv fentanyl and nebulized fentanyl provided effective analgesia in renal colic patients at the end of 30min. However, iv fentanyl provided more rapid and more effective analgesia than nebulized fentanyl. Patients receiving iv fentanyl had lower rescue analgesia requirements than those receiving nebulized fentanyl (37.1% vs 54.7%), although the difference was not statistically significant (p=0.058). In addition, side-effects were more common in the iv fentanyl group compared to the nebulized fentanyl group (22.1% vs 9.4%), although the difference was also not significant (p=0.058). CONCLUSION: Nebulized fentanyl provides effective analgesia in patients with renal colic. However, iv fentanyl exhibits more rapid and more powerful analgesic effects than nebulized fentanyl. Nonetheless, due to its ease of use and few potential risks and side-effects the nebulized form can be used as an alternative in renal colic.

The High Risk of Contrast-induced Nephropathy in Patients with Suspected Pulmonary Embolism Despite Three Different Prophylaxis: A Randomized Controlled Trial.

OBJECTIVE: The objective was to compare the protective effects of N-acetylcysteine (NAC) plus normal saline (NS), sodium bicarbonate (NaHCO3 ) plus NS, and NS alone in the prevention of contrast-induced nephropathy (CIN) after computed tomography pulmonary angiography (CTPA) in emergency patients. METHODS: This study was planned as a randomized, controlled clinical research. Patients undergoing contrast-enhanced CTPA on suspicion of pulmonary embolism (PE) in the emergency department and with at least one risk factor for development of CIN were included in one of three different prophylaxis groups. The groups received 3 mL/kg intravenous (IV) NAC+NS or NaHCO3 +NS solution or NS alone 1 hour before CTPA and 1 mL/kg IV per hour for a minimum of 6 hours after CTPA. CIN was evaluated as the primary outcome and moderate or severe renal insufficiency and in-hospital mortality as secondary outcomes. RESULTS: A total of 257 patients were enrolled in the study. The total level of CIN development was 23.7% (61/257), the level of moderate and severe renal failure was 12.5% (32/257), and the in-hospital mortality rate was 12.8% (33/257). Rates of CIN development in the drug groups were 23.5% in the NAC group (20/85), 21.2% (18/85) in the NaHCO3 group, and 26.4% in the NS group (23/87). Rates of development of moderate or severe renal insufficiency were 9.4% in the NAC group (8/85), 10.6% in the NaHCO3 group (9/85), and 17.2% in the NS group (15/87). In-hospital mortality rates were 12.9% in the NAC group (11/85), 11.8% in the NaHCO3 group (10/85), and 13.8% in the NS group (12/87). No difference was determined between the drug groups in terms of CIN, moderate or severe renal injury, or hospital mortality. CONCLUSIONS: Our results indicate that there is a high risk of CIN in patients with suspected PE despite three different types of prophylaxis being administered, and no statistically significant differences were observed among prophylactic NAC, NaHCO3 , and NS in prevention of CIN following contrast-enhanced CTPA.

Medicare claims data as public use files: a new tool for public health surveillance.

Claims data are an important source of data for public health surveillance but have not been widely used in the United States because of concern with personally identifiable health information and other issues. We describe the development and availability of a new set of public use files created using de-identified health care claims for fee-for-service Medicare beneficiaries, including individuals 65 years and older and individuals with disabilities younger than 65 years, and their application as tools for public health surveillance. We provide an overview of these files and their attributes; a review of beneficiary de-identification procedures and implications for analysis; a summary of advantages and limitations for use of the public use files for surveillance, alone and in combination with other data sources; and discussion and examples of their application for public health surveillance using examples that address chronic conditions monitoring, hospital readmissions, and prevalence and expenditures in diabetes care.

Self-management program participation by older adults with diabetes: Chronic Disease Self-Management Program and Diabetes Self-Management Program.

The Chronic Disease Self-Management Program and the Diabetes Self-Management Program offer evidence-based self-management for persons with diabetes. We examined participation and completion rates for older adults in the Communities Putting Prevention to Work initiative and found that completion is more likely (1) in Diabetes Self-Management Program for individuals with diabetes; (2) for Chronic Disease Self-Management Program and Diabetes Self-Management Program with introductory class zero; and (3) in small classes. We also found that participants reporting depression were less likely to complete either workshop. Future research is needed to examine workshop availability and selection, health and behavioral outcomes, and participant/completer experience.

Prevalence of chronic conditions among Medicare Part A beneficiaries in 2008 and 2010: are Medicare beneficiaries getting sicker?

INTRODUCTION: Medicare beneficiaries who have chronic conditions are responsible for a disproportionate share of Medicare fee-for-service expenditures. The objective of this study was to analyze the change in the health of Medicare beneficiaries enrolled in Part A (hospital insurance) between 2008 and 2010 by comparing the prevalence of 11 chronic conditions. METHODS: We conducted descriptive analyses using the 2008 and 2010 Chronic Conditions Public Use Files, which are newly available from the Centers for Medicare and Medicaid Services and have administrative (claims) data on 100% of the Medicare fee-for-service population. We examined the data by age, sex, and dual eligibility (eligibility for both Medicare and Medicaid). RESULTS: Medicare Part A beneficiaries had more chronic conditions on average in 2010 than in 2008. The percentage increase in the average number of chronic conditions was larger for dual-eligible beneficiaries (2.8%) than for nondual-eligible beneficiaries (1.2%). The prevalence of some chronic conditions, such as congestive heart failure, ischemic heart disease, and stroke/transient ischemic attack, decreased. The deterioration of average health was due to other chronic conditions: chronic kidney disease, depression, diabetes, osteoporosis, rheumatoid arthritis/osteoarthritis. Trends in Alzheimer's disease, cancer, and chronic obstructive pulmonary disease showed differences by sex or dual eligibility or both. CONCLUSION: Analyzing the prevalence of 11 chronic conditions by using Medicare claims data provides a monitoring tool that can guide health care providers and policy makers in devising strategies to address chronic conditions and rising health care costs.

Racial and ethnic minority participants in chronic disease self-management programs: findings from the Communities Putting Prevention to Work initiative.

BACKGROUND: The Communities Putting Prevention to Work: Chronic Disease Self-Management Program (CDSMP) Initiative funded grantees in 45 states, the District of Columbia and Puerto Rico to implement and expand delivery of CDSMP to older adults. We examine whether there are differences in the enrollment and completion rates of members of racial and ethnic minority groups and what sites have done to enhance their delivery of the CDSMP to such groups. METHOD: This study used a multi-method approach including: site visits to 6 states, telephone interviews with the 47 program grantees and delivery sites, review of program reports, and analysis of administrative data on participants, completers, workshops and leaders. RESULTS: Grantees served 89,861 participants, including 56.3% who self-identified as White, 17.3% as Black, 5.0% as other/multi-racial, 3.2% as Asian/Asian Americans, 1.4% as American Indian/Alaskans, .8% as Native Hawaiian/Pacific Islanders, and 16.0% individuals of unknown race. Overall, completion rates averaged 74.5%, with Native Hawaiian/Pacific Islanders completing workshops at a higher rate (90.6%) than other groups. Completion rates for participants aged > or = 75 were higher than for younger participants. Senior centers, health care organizations, and residential facilities served 63.1% of the participants. CONCLUSIONS: Grantees have successfully delivered CDSMP to racially and ethnically diverse participants in a range of settings. As the Administration for Community Living/Administration on Aging (ACL/AoA) grantees have demonstrated, CDSMP can be brought to scale by community organizations, partnerships and networks to reach diverse populations in diverse settings. The program can be a significant tool for addressing health disparities and empowering racial/ethnic minorities to take charge, promote better health and self-management of chronic conditions.

Medicare payments: how much do chronic conditions matter?

OBJECTIVE: Analyze differences in Medicare Fee-for-Service utilization (i.e., program payments) by beneficiary characteristics, such as gender, age, and prevalence of chronic conditions. METHODS: Using the 2008 and 2010 Chronic Conditions Public Use Files, we conduct a descriptive analysis of enrollment and program payments by gender, age categories, and eleven chronic conditions. RESULTS: We find that the effect of chronic conditions on Medicare payments is dramatic. Average Medicare payments increase significantly with the number of chronic conditions. Finally, we quantify the effect of individual conditions and find that "Stroke / Transient Ischemic Attack" and "Chronic Kidney Disease" are the costliest chronic conditions for Part A, and "Cancer" and "Chronic Kidney Disease" are the costliest for Part B.

What do researchers say about proposed Medicare claims public use files?

BACKGROUND: Medicare claims data sets have been used widely in outcomes research over the last decade. In 2010, the Centers for Medicare & Medicaid Services established a program to create de-identified basic standalone public use files (PUFs) from Medicare claims data, each one containing claims information from a 5% sample of beneficiaries. METHODS: We conducted a series of structured key informant interviews with research stakeholders to compile recommendations that would guide the creation of these PUFs. In this paper, we describe the interview methodology and present our findings. Fifteen researchers, representing a range of clinical health services and health policy expertise, were interviewed. RESULTS: All respondents supported the use of Medicare claims in comparative effectiveness research and responded favorably to the creation of PUFs for this purpose. The interviews resulted in administrative-, technical- and content-related recommendations, some of which led to important changes in the PUFs. DISCUSSION: A primary trade-off in the development of the proposed PUFs involved assuring maximum research utility of the files while assuring security of beneficiaries' protected health information. Protection of protected health information was considered a requirement. Given this constraint, the proposed PUFs may be most useful for two primary activities in comparative effectiveness research: first, working through the beginning stages of a research project; and second, examining high-level questions.

The effect of vascular endothelial growth factor on spermatogenesis and apoptosis in experimentally varicocele-induced adolescent rats.

OBJECTIVE: To investigate the effect of vascular endothelial growth factor (VEGF) injection into the testes on spermatogenesis and apoptosis in a varicocele-induced adolescent rat model. SETTING: University hospital urology research laboratory. ANIMAL(S): Six-week-old male Wistar rats (n = 32). INTERVENTION: The rats were divided into six groups: control group (n = 6), sham operated group (n = 6), left varicocele-induced group (n = 6), varicocele + varicocelectomy group (n = 6), varicocele + VEGF-injected group (n = 4), and varicocele + varicocelectomy + VEGF-injected group (n = 4). MAIN OUTCOME MEASURE(S): Johnsen's score and apoptotic cells. RESULT(S): The mean Johnsen's score was lower in the varicocele group compared with in the control and sham groups. The mean apoptotic index was significantly higher in the varicocele group compared with in the control and sham groups. Compared with the varicocele group, the mean apoptotic index was significantly lower in the varicocele + varicocelectomy, varicocele + VEGF, and varicocele + varicocelectomy + VEGF groups. CONCLUSION(S): Varicocele may cause a decrease in spermatogenesis and an increase in the apoptotic index. VEGF may play a positive role in improving testicular damage and may also play a significant role in decreasing apoptosis in a varicocele-induced adolescent rat model.

Ham's F-10 medium and Ham's F-10 medium plus vitamin E have protective effect against oxidative stress in human semen.

OBJECTIVES: To investigate possible protective effects of vitamin E and Ham's F-10 medium (HF-10) on lipid peroxidation, apoptosis, motility, and vitality of spermatozoa. METHODS: Normozoospermic semen samples were obtained from 35 volunteers. Normal saline solution, HF-10 only, or HF-10 with vitamin E were added to split semen samples (control, group 1, and group 2, respectively). Sperm motility and vitality were evaluated at the end of 1, 2, and 24 hours. Superoxide dismutase, catalase, and malondialdehyde levels were assessed at the end of the first hour. Flow cytometric DNA analysis was performed at the end of 24 hours. RESULTS: Superoxide dismutase, sperm motility, and vitality were not different among the groups. The catalase values decreased in group 1, but not in group 2. Malondialdehyde values in supernatants decreased in group 2 and apoptosis of spermatozoa decreased in groups 1 and 2. CONCLUSIONS: Our data suggest that vitamin E and HF-10 protect against the reactive oxygen species-mediated damage on spermatozoa.