A Case for Synthetic Data in Regulatory Decision-Making in Europe.

Regulators are faced with many challenges surrounding health data usage, including privacy, fragmentation, validity, and generalizability, especially in the European Union, for which synthetic data may provide innovative solutions. Synthetic data, defined as data artificially generated rather than captured in the real world, are increasingly being used for healthcare research purposes as a proxy to real-world data (RWD). Currently, there are barriers particularly challenging in Europe, where sharing patient's data is strictly regulated, costly, and time-consuming, causing delays in evidence generation and regulatory approvals. Recent initiatives are encouraging the use of synthetic data in regulatory decision making and health technology assessment to overcome these challenges, but synthetic data have still to overcome realistic obstacles before their adoption by researchers and regulators in Europe. Thus, the emerging use of RWD and synthetic data by pharmaceutical and medical device industries calls regulatory bodies to provide a framework for proper evidence generation and informed regulatory decision making. As the provision of data becomes more ubiquitous in scientific research, so will innovations in artificial intelligence, machine learning, and generation of synthetic data, making the exploration and intricacies of this topic all the more important and timely. In this review, we discuss the potential merits and challenges of synthetic data in the context of decision making in the European regulatory environment. We explore the current uses of synthetic data and ongoing initiatives, the value of synthetic data for regulatory purposes, and realistic barriers to the adoption of synthetic data in healthcare.

High unmet treatment needs in patients with chronic kidney disease and type 2 diabetes: real-world evidence from a US claims database.

BACKGROUND: Chronic kidney disease (CKD), a serious complication of type 2 diabetes (T2D) increases the comorbid risk of cardiovascular disease (CVD) and end-stage kidney disease(ESKD). Treatment guidelines recommend renin-angiotensin blockade and antihyperglycemic treatment with metformin and sodium-glucose cotransporter 2 inhibitors (SGLT2is) as first-line treatment. We evaluated treatment initiation and discontinuation overall and in subgroups of T2D patients with incident CKD (incident cohort) and rates of clinical and economic outcomes in patients with T2D and any CKD (prevalent cohort). METHODS: In this retrospective study of administrative claims in the USA between 1 January 2007 and 31 March 2019, we evaluated the proportion of patients with concomitant, newly initiated and discontinued use of antihypertensive [angiotensin-converting enzyme inhibitor (ACEi)/angiotensin II receptor blockers (ARBs), steroidal mineralocorticoid receptor antagonists (sMRAs)] and antidiabetic [SGLT2is, dipeptidyl peptidase-4 inhibitors (DPP4is), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), insulin and sulfonylureas] medications, rates of clinical outcomes per 1000 person-years and mean total healthcare costs. RESULTS: We identified 63 127 and 326 763 patients in the incident and prevalent CKD cohorts, respectively. Low initiation and high discontinuation rates were observed with 17.8% and 56.0% for ACEi/ARBs, 1.3% and 66.0% for sMRAs, 2.5% and 65.0% for SGLT2is, 3.7% and 66.8% for DPP4is, 2.31% and 69.0% for GLP-1 RAs, 4% and 75.7% for insulin and 5.5% and 56.9% for sulfonylureas. Similar results were seen by subgroups. Rates of clinical outcomes ranged from 35.07 per 1000 person-years for all-cause mortality to 104.19 for ESKD, with rates of hospitalization ranging from 36.61 for kidney hospitalizations to 283.14 for all-cause hospitalizations. Among patients with comorbidities, higher clinical and economic outcomes were found. CONCLUSION: Our results highlight high unmet needs of CKD and T2D, particularly subgroups of patients with multimorbid CVD, high-risk CKD (low estimated glomerular filtration rate or high urinary albumin:creatinine ratio) or rapidly progressing CKD. Low initiation and high discontinuation of recommended treatments suggest that adherence to guidelines for halting CKD progression is suboptimal. These high-risk patients may benefit from further treatment options to improve morbidity and mortality and reduce the economic burden.

Durability of the Single-Dose Ad26.COV2.S Vaccine in the Prevention of COVID-19 Infections and Hospitalizations in the US Before and During the Delta Variant Surge.

Importance: Vaccination against the SARS-CoV-2 virus is critical to control the pandemic. Randomized clinical trials demonstrated efficacy of the single-dose Ad26.COV2.S COVID-19 vaccine, but data on longer-term protection in clinical practice and effectiveness against variants are needed. Objective: To assess the association between receiving the Ad26.COV2.S vaccine and COVID-19-related infections and hospitalizations before and during the Delta variant surge. Design, Setting, and Participants: This cohort study included adults aged 18 years and older who were newly Ad26.COV2.S-vaccinated matched to as many as 10 unvaccinated individuals by date, location, age, sex, and comorbidity index. This was followed by 1:4 propensity score matching on COVID-19 risk factors. Data were collected from US insurance claims data from March 1, 2020, through August 31, 2021. Exposures: Vaccination with Ad26.COV2.S vs no vaccination. Main Outcomes and Measures: Vaccine effectiveness (VE) was estimated for recorded COVID-19 infection and COVID-19-related hospitalization, nationwide and in subgroups by age, high-risk factors, calendar time, and states with high incidences of the Delta variant. VE estimates were corrected for underrecording of vaccinations in insurance data. Results: Among 422 034 vaccinated individuals (mean [SD] age, 54.7 [17.4] years; 236 437 [56.0%] women) and 1 645 397 matched unvaccinated individuals (mean [SD] age, 54.5 [17.5] years; 922 937 [56.1%] women), VE was 76% (95% CI, 75%-77%) for COVID-19 infections and 81% (95% CI, 78%-82%) for COVID-19-related hospitalizations. VE was stable for at least 180 days after vaccination and over calendar time. Among states with high Delta variant incidence, VE during June to August 2021 was 74% (95% CI, 71%-77%) for infections and 81% (95% CI, 75%-86%) for hospitalizations. VE for COVID-19 was higher in individuals younger than 65 years (78%; 95% CI, 77%-79%) and lower in immunocompromised patients (64%; 95% CI, 59%-68%). All estimates were corrected for vaccination underrecording; uncorrected VE, which served as a lower bound, was 66% (95% CI, 64%-67%) for any recorded COVID-19 infection and 72% (95% CI, 69%-74%) for COVID-19-related hospitalization. Conclusions and Relevance: This cohort study in US clinical practice showed stable VE of Ad26.COV2.S for at least 6 months before as well as during the time the Delta variant emerged and became dominant.

Predictors of cardio-kidney complications and treatment failure in patients with chronic kidney disease and type 2 diabetes treated with SGLT2 inhibitors.

BACKGROUND: Clinical practice guidelines recommend sodium-glucose co-transporter 2 inhibitors (SGLT2is) to mitigate adverse kidney and cardiovascular outcomes in patients with type 2 diabetes (T2D), including patients with comorbid chronic kidney disease (CKD), also referred to as diabetic kidney disease (DKD), who are at even higher risk. In this study, we sought to identify predictors of cardio-kidney events, cardio-kidney complications, and treatment failure (i.e., addition/initiation of a new T2D class, insulin, or discontinuation of SGLT2is) after new initiation of SGLT2is in patients with CKD and T2D (DKD). METHODS: In this retrospective cohort study, we identified adult patients with DKD who initiated SGLT2is between April 1, 2012, and June 30, 2019, in Optum claims data. Outcome rates per 1000 person-years (PY) are reported with 95% confidence intervals (CIs). Cox proportional hazards regression identified patient characteristics associated with each outcome. RESULTS: The study population consisted of 6389 initiators of SGLT2is. The rate of CV hospitalization was 26.0 (95% CI 21.6, 30.4) per 1000 PY. Baseline characteristics associated with higher risk of CV hospitalization included age, atrial fibrillation, peripheral vascular disease (PVD), and cancer. The rate of kidney hospitalization was 12.0 (95% CI 9.0, 15.0) per 1000 PY. The risk increased significantly with baseline evidence of heart failure, hyperkalemia, respiratory failure, depression, and use of loop diuretics. In total, 55.0% of all SGLT2i initiators discontinued treatment during the follow-up period. The rate of treatment failure was 510.5 (95% CI 492.9, 528.1) per 1000 PY. Analysis of key time-dependent SGLT2i-associated adverse events showed that experiencing diabetic ketoacidosis and volume depletion were associated with risk of treatment failure. CONCLUSIONS: Our study demonstrated high rates of residual cardio-kidney outcomes and treatment failure in patients with DKD treated with SGLT2is. Patients with high baseline CV risk and the presence of certain conditions, such as atrial fibrillation, PVD, and heart failure, were at higher risk for cardio-kidney events. Further research is needed to assess the potential relationship between adverse events and SGLT2i treatment failure.

Real-world healthcare resource utilization and costs of weekly versus every-2-week cetuximab in metastatic colorectal cancer.

Aim: To compare healthcare resource utilization (HRU) and healthcare costs (HC) for every-2-week (Q2W) versus weekly (Q1W) cetuximab in metastatic colorectal cancer (mCRC). Patients & methods: Patients with mCRC receiving cetuximab plus chemotherapy in a line-agnostic setting. Cohort study of patients with mCRC treated with cetuximab and chemotherapy in IBM MarketScan. Analyses were weighted by inverse probability of treatment based on propensity score. Results: HRU was numerically lower with the Q2W versus Q1W regimen (weighted mean, 8.1 vs 9.5 encounters per-patient-per-month). The weighted average of HC was $17,653 and $16,469 per-patient-per-month for the Q2W and Q1W regimens, respectively; the difference between regimens decreased when restricting to CRC-related claims. Conclusion: HRU was lower and HC were similar between the Q2W and Q1W regimens.

The "Empty Merchant Sign" in acute patellar tendon ruptures.

INTRODUCTION: We introduce a new sign on a Merchant view present in acute patellar tendon ruptures (APTR). We aim to determine the accuracy, sensitivity, and specificity of this new radiographic sign and measure the effect of a tutorial on these measures between trainees and non-trainees. METHODS: Lateral and Merchant radiographs (22 images) of knees with four conditions (patellar instability, APTR, quadriceps tendon rupture, and controls) were randomly shown to 50 trainees and non-trainees who were asked to make a diagnosis based on radiographs. A brief tutorial was administered describing the "Empty Merchant Sign" and the same 22 images were randomly shown after the tutorial. Accuracy, sensitivity, specificity, and positive predictive value were calculated between the two image types and the effect of tutorial on these measures was assessed. RESULTS: After the tutorial: 1. the "Empty Merchant Sign" had a higher specificity (100%) and positive predictive value (99%) compared to the lateral radiograph (81% and 64% respectively, P < 0.001), 2. There was significant improvement (from 56% to 95.3%; P < 0.001) in the accuracy of the Merchant view, making it as accurate as the lateral view (95.3% vs. 90.7%, respectively; P = 0.113). There was no difference in the accuracy of the Merchant view between trainees (97.2%) and non-trainees (90.5%) (P = 0.079). CONCLUSION: The "Empty Merchant Sign" is a highly sensitive and specific diagnostic sign in cases of APTR. With very little training, physicians can identify this sign to diagnose APTRs on a Merchant view.

Comparative effectiveness of weekly versus every-2-weeks cetuximab in metastatic colorectal cancer in a US-insured population.

Aim: To test the noninferiority of cetuximab administered every 2 weeks (Q2W) versus once weekly (Q1W) in treating metastatic colorectal cancer (mCRC) with regard to overall survival (OS). Patients: Patients receiving cetuximab plus chemotherapy for mCRC in a line-agnostic setting. Methods: This cohort study in IBM MarketScan followed patients from initiation of cetuximab for mCRC until the end of the data availability period, proxy-based death or loss of insurance coverage for >30 days. Results: The hazard ratio for OS was 0.94 (0.85-1.03), and the inferiority hypothesis was rejected at p < 0.001. No significant differences were noted in rates of safety events between Q2W and Q1W. Conclusion: Our real-world study confirmed the noninferiority of cetuximab administered Q2W versus Q1W for OS.

Is there a difference in the acromiohumeral distances measured on radiographic and magnetic resonance images of the same shoulder with a massive rotator cuff tear?

BACKGROUND: The purpose of our study was to compare the acromiohumeral distance (AHD) between radiographic and magnetic resonance images (MRIs) of the same shoulder with massive rotator cuff tears (MRCTs). METHODS: Thirty-four shoulders with MRCTs that had an MRI and radiograph of the same shoulder within an average of 40.3 days (range: 8-109 days) were identified. AHD was measured digitally on radiograph and MRI by 3 examiners. Shoulders were grouped into Hamada grades <3 (group 1) and Hamada grades ≥3 (group 2). RESULTS: The mean age was 66.4 years (range: 51-89). There were 19 men (59%). The Kappa for inter-rater reliability was 0.982 (95% confidence interval [CI] 0.975, 0.988) for radiographs and 0.88 (95% CI 0.75, 0.94) for MRI. There was a significant difference in the mean AHD of group 1 on radiograph vs. MRI (7.9 mm vs. 2.5 mm, respectively; P < .0001), but no difference in group 2 (1.8 mm vs. 2.2 mm, respectively; P = .45). There was no difference in AHD in group 1 between shoulders with Goutallier stage <3 (8.1 ± 1.9 mm) and those with Goutallier stage ≥3 (7.3 ± 2.1 mm) (P = .3479). There was no difference in AHD in group 2 between shoulders with Goutallier stage <3 (3.0 ± 0.1 mm) and those with Goutallier stage ≥3 (1.5 ± 1.0 mm) (P = .079). CONCLUSION: There is a significant difference in AHD measurements between radiograph and MRI of the same shoulder with MRCT in early Hamada grades. AHDs measured on radiograph and MRI should not be used interchangeably in early Hamada grades to assess outcomes of superior capsule reconstruction and similar procedures.

Bipolar Osteochondral Allograft Transplantation of the Patella and Trochlea.

OBJECTIVE: To evaluate clinical, functional, and radiographic outcomes of patients who underwent bipolar osteochondral allograft transplantation (OCAT) of the patellofemoral joint (PFJ). DESIGN: Prospectively collected data on 18 knees who underwent fresh osteochondral allograft transplantation of the patella and trochlea by a single surgeon were reviewed. Inclusion criteria were: high-grade chondral lesions of PFJ (5 knees), or recurrent patella dislocations with trochlear dysplasia and chondral injury to the patella and/or trochlea (13 knees). Functional scores were obtained preoperatively and at follow-up appointments included Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC), Oxford, Cincinnati, Tenger-Lysholm, visual analogue scale (VAS)-pain, and Single Assessment Numeric Evaluation (SANE). Grafts were also evaluated using Osteochondral Allograft MRI Scoring System (OCAMRISS). RESULTS: Three patients were lost to follow-up, leaving 4 knees in group 1, and 11 knees in group 2. Average age was 28.9 years (range 16-52 years). The average follow-up was 33.2 months (range 12-64 months). There was significant improvement of KOOS (from 38.7 to 83.1), IKDC (from 28.2 to 76.6), Tegner-Lysholm (from 38.3 to 88.3), Oxford (from 22.7 to 42.9), Cincinnati (from 35.1 to 83.6), VAS (from 71 to 17.9.), and SANE (from 43.3 to 83) (P < 0.0001). The OCAMRISS score for patella was 2.23 and for trochlea 4.69. There were no revisions or conversions to arthroplasty. CONCLUSION: Bipolar OCAT of the patella and trochlea provide significant improvement in functional outcomes, relief from pain, activity level, and prevent recurrent instability.

Failed Dermal Allograft Procedures for Irreparable Rotator Cuff Tears Can Still Improve Pain and Function: The "Biologic Tuberoplasty Effect".

BACKGROUND: Acellular dermal matrices (ADMs) have been used in the treatment of shoulders with massive rotator cuff tears (MRCTs). Despite clinical improvement, correlation of clinical findings with ADM integrity on imaging has not been investigated. HYPOTHESIS: The pain in shoulders with MRCTs is partially due to bone-to-bone contact between the tuberosity and acromion. Coverage of the tuberosity with an intact graft or a graft that is torn in a way that the tuberosity remains covered will act as an interpositional tissue, preventing bone-to-bone contact and leading to clinical improvement. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Between 2006 and 2016, a total of 25 shoulders with MRCTs underwent a procedure with an ADM. Pre- and postoperative visual analog scale (VAS) results, American Shoulder and Elbow Surgeons (ASES) score, Hamada grade, and Goutallier classification were reviewed. A postoperative magnetic resonance imaging (MRI) was obtained in 22 (88%) shoulders. The status of the graft was divided into the following categories: type I, intact graft; type II, graft tear with tuberosity covered; and type III, graft tear with tuberosity uncovered (bare). RESULTS: The mean patient age was 61 years (range, 49-73 years), and the mean follow-up was 25.6 months (range, 10-80 months). Mean length from surgery to postoperative MRI was 13.9 months (range, 6-80 months). The graft was torn in 59% (13/22 shoulders). Significant improvements were found in VAS and ASES scores (7 vs 0.7 and 32.6 vs 91.2, respectively; P < .01) for type I grafts and in VAS and ASES scores (8.1 vs 1.3 and 26.3 vs 84.6, respectively; P < .01) for type II grafts. No difference was found in postoperative VAS and ASES (0.7 vs 1.3 and 91.2 vs 84.6, respectively; P = .8) between type I and type II grafts. No improvement was seen in VAS (7.3 vs 5.7; P = .2) or ASES (30.6 vs 37.2; P = .5) for type III grafts. CONCLUSION: MRI appearance of the graft has a significant impact on functional outcomes. Patients with an intact graft or a graft tear leaving the tuberosity covered have lower pain and higher functional scores than those in whom the torn graft leaves the tuberosity uncovered.

Health Status of Young Adults with Insurance Coverage Before and After Affordable Care Act Passage.

INTRODUCTION: The purpose of this study was to assess changes in health status of California young adults with insurance coverage before and after passage of the Affordable Care Act (ACA). METHODS: For this cross-sectional descriptive study, electronic health record information for young adults between ages 18 and 25 years enrolled in a large Southern California Health Plan in 2008, 2010, or 2015 was obtained (N = 665,686). Absolute changes and standardized annual differences in demographics and age-sex-race standardized prevalence of Elixhauser health conditions for pre-ACA (2008-2010) and post-ACA (2010-2015) periods were calculated. RESULTS: The number of young adults enrolled in the Health Plan increased by 145,000 (65%) during the ACA transition with a shift toward low-income young adults. The increase in high-deductible insurance plans observed pre-ACA stabilized with a standardized annual difference of 0.22 pre-ACA vs 0.05 post-ACA. The prevalences of obesity and other health conditions between pre-ACA and post-ACA periods essentially were unaltered and comparable between young adults who became new members (< 1 year) and those with long-term memberships (≥ 3 years). CONCLUSION: In this California health care system, the health status of new young adult members was comparable to that of long-term members. Future research should assess whether these young adults retain their health insurance coverage after turning age 26 years and being removed from their parents' insurance plans.

Influence of Ambulatory Triglyceride Levels on Risk of Recurrence in Patients with Hypertriglyceridemic Pancreatitis.

BACKGROUND AND AIMS: To evaluate impact of ambulatory triglyceride levels on risk of recurrent pancreatitis in patients with hypertriglyceridemic pancreatitis. METHODS: We conducted a longitudinal retrospective cohort study of patients with serum triglyceride level ≥ 500 mg/dL during index hospitalization for acute pancreatitis within a regional integrated healthcare system between 2006 and 2013 (follow-up through 2015). Cases were identified based on combination of diagnosis codes and serum amylase/lipase. We used multivariable robust Poisson regression to determine independent effect of baseline (first outpatient) triglyceride measurement on risk of recurrent pancreatitis. Ambulatory triglyceride levels were categorized as normal (0-200 mg/dL), moderately elevated (201-500 mg/dL), and highly elevated (> 500 mg/dL). We further assessed factors related to likelihood of normalization of serum triglycerides (< 200 mg/dL) in the outpatient setting. RESULTS: One hundred and fifty-one patients met study inclusion criteria with median follow-up of 3 years. Overall, 45 (29.8%) patients experienced at least 1 recurrent attack with 25 (16.6%) experiencing multiple episodes. In multivariable analysis, patients that continued to have moderately elevated ((adjusted rate ratio RR 5.47 (95% CL 1.80, 16.65)) as well as highly elevated (RR 8.45 (2.55, 27.96)) triglycerides were at increased risk of disease recurrence compared to patients that achieved normalization. Patients with triglyceride measurement performed within 30 days from discharge were more likely to achieve normalization, 40 versus 26%, p = 0.03. CONCLUSIONS: For patients with hypertriglyceridemic pancreatitis, even modest elevation in subsequent triglyceride levels was associated with increased risk of recurrence. Future efforts should focus on ensuring timely care in the outpatient setting with a goal of normalizing triglycerides.

Complications of biceps tenodesis based on location, fixation, and indication: a review of 1526 shoulders.

BACKGROUND: Long head of the biceps tendon (LHBT) tenodesis is predominantly performed for 2 reasons: anterior shoulder pain (ASP) or structural reasons (partial tear, dislocation). METHODS: Between 2006 and 2014, all cases of primary LHBT tenodesis performed at an integrated health care system were retrospectively reviewed. Complications were analyzed by tenodesis location (below or out of the groove [OOG] vs leaving tendon in the groove [ITG]), fixation method (soft tissue vs implant), and indication (preoperative ASP vs structural). RESULTS: Among 1526 shoulders, persistent ASP did not differ by fixation method (11.0% for implant vs 12.8% for soft tissue, P = .550) or location (10.8% for OOG vs 12.9% for ITG, P = .472). Soft-tissue tenodesis cases had more frequent new-onset ASP (11.9% vs 2.6%, P < .001) and subjective weakness (8.50% vs 3.92%, P < .001) but less frequent revisions (0% vs 1.19%, P = .03) than implant tenodesis cases. No difference was found between ITG and OOG for persistent ASP (12.9% vs 10.8%, P = .550), new-onset ASP (6.5% vs 2.8%, P = .339), cramping (1.70% vs 2.31%, P = .737), deformity (4.72% vs 4.62%, P = .532), or subjective weakness (6.23% vs 4.32%, P = .334), but ITG cases had more revisions (1.51% vs 0.60%, P = .001). Among implant tenodesis cases, 1 shoulder (0.085%) sustained a fracture. CONCLUSION: The overall complication rate of LHBT tenodesis was low. Of the shoulders, 10.8% to 12.9% continued to have ASP, regardless of whether the LHBT was left ITG. Soft-tissue tenodesis cases had higher rates of new-onset ASP and subjective weakness. No significant difference for tenodesis ITG or OOG was found in biceps-related complications.

Myopia prevalence and risk factors in children.

PURPOSE: To evaluate the prevalence and risk factors for pediatric myopia in a contemporary American cohort. METHODS: A cross-sectional study of pediatric patients enrolled in the Kaiser Permanente Southern California health plan was done. Eligible patients were 5- to 19-years old between January 1, 2008, through December 31, 2013, and received an ophthalmologic or optometric refraction. Electronic medical records were reviewed for demographic data, refraction results, and exercise data. Prevalence and relative risks of myopia (defined as ≤-1.0 diopter) were characterized. Age, sex, race/ethnicity, median neighborhood income, and minutes of exercise per day were examined as risk factors. RESULTS: There were 60,789 patients who met the inclusion criteria, of which 41.9% had myopia. Myopia was more common in older children (14.8% in 5- to 7-year olds, 59.0% in 17- to 19-year olds). Asian/Pacific Islander patients (OR 1.64, CI 1.58-1.70) had an increased rate of myopia compared to White patients as did African Americans to a lesser extent (OR 1.08, CI 1.03-1.13). Median neighborhood household income of $25,000-40,000 was associated with lower rates of myopia (OR 0.90, CI 0.83-0.97) compared to median neighborhood household incomes less than $25,000. Having at least 60 min of daily exercise was associated with lower prevalence of myopia (OR 0.87, CI 0.85-0.89). DISCUSSION: Myopia was common in this large and diverse Southern Californian pediatric cohort. The prevalence of myopia increases with age. Asian children are at highest risk for myopia. Exercise is associated with a lower rate of myopia and represents an important potentially modifiable risk factor that may be a target for future public health efforts.

Association between encounter frequency and time to blood pressure control among patients with newly diagnosed hypertension: a retrospective cohort study.

This retrospective cohort study of 95 957 patients from a large integrated healthcare organization was conducted to examine whether the frequency and intervals between outpatient encounters were associated with achieving blood pressure (BP) control. Patients were followed up until they were censored or achieved BP control up to 1 year. Additionally, this study examined the time to BP control. On average, follow-up was significantly longer in patients with uncontrolled BP at 292.9 days compared with 232.2 days in those with BP control. The controlled BP group had significantly more encounters on average compared with the uncontrolled BP group (4.1 vs 3.1, standardized difference 0.33). As the number of days increased between encounters from the 1 to < 14 days, there was a consistently lower likelihood of achieving BP control. Encounter intervals of ≥180 days were associated with the lowest likelihood of achieving BP control. These findings suggest that there may be an optimal number of encounters to benefit patients with hypertension.

End-Stage Renal Disease and Mortality Outcomes Across Different Glomerulonephropathies in a Large Diverse US Population.

OBJECTIVE: To compare renal function decline, incident end-stage renal disease (ESRD), and mortality among patients with 5 common glomerular diseases in a large diverse population. PATIENTS AND METHODS: A retrospective cohort study (between January 1, 2000, and December 31, 2011) of patients with glomerulonephropathy using the electronic health record of an integrated health system was performed. Estimated glomerular filtration rate (eGFR) change, incident ESRD, and mortality were compared among patients with biopsy-proven focal segmental glomerulosclerosis (FSGS), membranous glomerulonephritis (MN), minimal change disease (MCD), immunoglobulin A nephropathy (IgAN), and lupus nephritis (LN). Competing risk models were used to estimate hazard ratios for different glomerulonephropathies for incident ESRD, with mortality as a competing outcome after adjusting for potential confounders. RESULTS: Of the 2350 patients with glomerulonephropathy (208 patients [9%] younger than 18 years) with a mean follow-up of 4.5±3.6 years, 497 (21%) progressed to ESRD and 195 (8%) died before ESRD. The median eGFR decline was 1.0 mL/min per 1.73 m2 per year but varied across different glomerulonephropathies (P<.001). The highest ESRD incidence (per 100 person-years) was observed in FSGS 8.72 (95% CI, 3.93-16.72) followed by IgAN (4.54; 95% CI, 1.37-11.02), LN (2.38; 95% CI, 0.37-7.82), MN (2.15; 95% CI, 0.29-7.46), and MCD (1.67; 95% CI, 0.15-6.69). Compared with MCD, hazard ratios (95% CIs) for incident ESRD were 3.43 (2.32-5.08) and 2.35 (1.46-3.81), 1.28 (0.79-2.07), and 1.02 (0.62-1.68) for FSGS, IgAN, LN, and MN, respectively. No significant association between glomerulonephropathy types and mortality was detected (P=.24). CONCLUSION: Our findings from a real-world clinical environment revealed significant differences in eGFR decline and ESRD risk among patients with 5 glomerulonephropathies. These variations in presentation and outcomes warrant different management strategies and expectations.

Surgical Treatment of Distal Biceps Tendon Ruptures: An Analysis of Complications in 784 Surgical Repairs.

BACKGROUND: Distal biceps brachii tendon ruptures lead to substantial deficits in elbow flexion and supination; surgical repair restores muscle strength and endurance. PURPOSE: To examine clinical and surgical outcomes for distal biceps tendon repairs in a large, multispecialty, integrated health care system. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Retrospective cohort study of distal biceps tendon repairs performed between January 1, 2008, and December 31, 2015. The repair methods were classified as double-incision approach using bone tunnel-suture fixation or anterior single-incision approach. Anterior single incisions were further classified according to the fixation method: cortical button alone, cortical button and interference screw, or suture anchors alone. Patient demographics, surgeon characteristics, range of motion, and complications were analyzed for all repair types. RESULTS: Of the 784 repairs that met the inclusion criteria, 639 (81.5%) were single-incision approaches. When comparing double-incision and single-incision repairs, there was a significantly higher rate of posterior interosseous nerve palsy (3.4% vs 0.8%, P = .010), heterotopic bone formation (7.6% vs 2.7%, P = .004), and reoperation (8.3% vs 2.3%, P < .001). The most common nerve complication encountered was a lateral antebrachial cutaneous nerve palsy (n = 162), which was significantly more common in the single-incision repairs than in the double-incision repairs (24.4% vs 4.1%, P < .001). When excluding lateral antebrachial cutaneous nerve palsies, there was no significant difference in the overall nerve palsies between single-incision and double-incision (5.8% vs 6.9%, P = .612). The overall rate of tendon rerupture was 1.9% (single incision, 1.6%; double incision, 2.8%; P = .327). The overall rate of postoperative wound infection was 1.5% (single incision, 1.3%; double incision, 2.8%; P = .182). The average time from surgery to release from medical care was 14.4 weeks (single incision, 14 weeks; double incision, 16 weeks; P = .286). Patients treated with cortical button plus interference screw were released significantly sooner than were patients with other single-incision repair types (13.1 ± 8.01 weeks, P = .011). There were no significant differences in rates of motor neurapraxia, infection, rerupture, and reoperation with regard to surgeon's years of practice, fellowship training, or case volume. CONCLUSION: The surgical repair of distal biceps tendon ruptures has an overall low rate of serious complications, regardless of approach or technique. However, the double-incision technique has a higher rate of posterior interosseous nerve palsy, heterotopic bone formation, and reoperation rate. Surgeon's years of practice, fellowship training, and case volume do not affect the rate of major complications.

Effect of Serum Triglycerides on Clinical Outcomes in Acute Pancreatitis: Findings From a Regional Integrated Health Care System.

OBJECTIVES: The aim of this study was to evaluate the effect of serum triglycerides on the development of multiple or persistent organ failure in patients with acute pancreatitis. METHODS: A retrospective cohort study was conducted among patients hospitalized for acute pancreatitis between 2006 and 2013. Triglyceride levels measured before and within 72 hours of admission were compared. In addition, the effect of triglyceride levels on the development of multiple or persistent organ failure during hospitalization for acute pancreatitis was assessed. RESULTS: Among 2519 patients, 267 patients (10.6%) developed organ failure, of which 75 patients developed multiple system organ failure and 82 patients developed persistent organ failure. Triglyceride levels in patients who developed organ failure were initially much higher than in patients who did not develop organ failure, but by 72 hours into admission, approached levels of patients who did not develop organ failure. Approximately 8% of patients had triglyceride levels greater than 500 mg/dL, the majority of which had similarly high levels before admission. CONCLUSIONS: Increased triglyceride levels were associated with the development of multiple or persistent organ failure among patients hospitalized with acute pancreatitis. Patients with high triglyceride levels at the time of admission were likely to have high triglyceride levels before admission.

In Vivo Analysis of Biceps Tendon Characteristics in Subpectoral Tenodesis.

PURPOSE: To report the in vivo characteristics of the long head of the biceps tendon (LHBT); to evaluate the relation of age, gender, height, weight, and body mass index to the length and sutured and tubularized diameter of the LHBT; and to determine the smallest possible tunnel diameter for a subpectoral biceps tenodesis (SPBT) that can accommodate most patients. METHODS: The study included 66 patients (33 men and 33 women) with an average age of 54 years (range, 29-73 years) undergoing SPBT. After tenotomy, the length from the biceps musculotendinous junction to the released end was measured. The tendon was transected 3 cm proximal to the musculotendinous junction and sutured, and the diameter was measured. The depth of the reamed tunnel was recorded. RESULTS: The average tendon length was 84.0 mm, measuring 91.9 mm in men and 76.2 mm in women (P < .001), and the average tendon diameter was 4.4 mm, varying slightly between men (4.5 mm) and women (4.3 mm) (P < .001). Mean bone tunnel depth was 17.5 mm, with 19 mm in men and 16.1 mm in women (P < .001). Patient height showed a significant relation to both tendon length and tendon diameter. Weight was not correlated with tendon diameter but did show a significant relation to tendon length. CONCLUSIONS: We have characterized the in vivo length and diameter of the LHBT at the time of an SPBT. Our findings have shown that there was a statistically significant gender difference in tendon length and diameter, but the diameter of the sutured tendon, which was placed into the tunnel, averaged 4.4 mm and ranged from 3.5 to 5 mm for all ages, both genders, all heights, and all weights. This finding is clinically relevant in that a small tunnel measuring 5.5 mm or less is sufficient to perform an SPBT. LEVEL OF EVIDENCE: Level IV, case series, anatomic study.