The helping older people engage (HOPE) study: Protocol & COVID modifications for a randomized trial.

Objectives: Evidence-based strategies to reduce loneliness in later life are needed because loneliness impacts all domains of health, functioning, and quality of life. Volunteering is a promising strategy, as a large literature of observational studies documents associations between volunteering and better health and well-being. However, relatively few studies have used randomized controlled trials (RCTs) to examine benefits of volunteering, and none have examined loneliness. The primary objective of the Helping Older People Engage (HOPE) study is to examine the social-emotional benefits of a social volunteering program for lonely older adults. This manuscript describes the rationale and design of the trial. Methods: We are randomly assigning adults aged 60 or older (up to 300) who report loneliness to 12 months of either AmeriCorps Seniors volunteering program or an active control (self-guided life review). Co-primary outcomes are assessed via self-report-loneliness (UCLA Loneliness Scale) and quality of life (WHOQOL-Bref). Enrollment was completed in May 2022 and follow-up assessments will continue through May 2023, with completion of primary outcomes soon thereafter. Conclusions: Since older adults who report loneliness are less likely to actively seek out volunteering opportunities, if results support efficacy of volunteering for reducing loneliness, dissemination and scaling up efforts may involve connecting primary care patients who are lonely with AmeriCorps Seniors through aging services agencies.This RCT is registered at clinicaltrials.gov (NCT03343483).

Effect of altitude on mortality of end-stage renal disease patients on hemodialysis in Peru.

BACKGROUND: In Latin America, the prevalence of end-stage kidney disease (ESKD) has risen tremendously during the last decade. Previous studies have suggested that receiving dialysis at high altitude confers mortality benefits; however, this effect has not been demonstrated at >2000 m above sea level (masl) or in developing countries. METHODS: This historical cohort study analyzed medical records from six Peruvian hemodialysis (HD) centers located at altitudes ranging from 44 to 3827 masl. Adult ESKD patients who started maintenance HD between 2000 and 2010 were included. Patients were classified into two strata based on the elevation above sea level of their city of residence: low altitude (<2000 masl) and high altitude (≥2000 masl). Death from any cause was collected from national registries and Cox proportional hazards models were built. RESULTS: A total of 720 patients were enrolled and 163 (22.6%) resided at high altitude. The low-altitude group was significantly younger, more likely to have diabetes or glomerulonephritis as the cause of ESKD and higher hemoglobin. The all-cause mortality rate was 84.3 per 1000 person-years. In the unadjusted Cox model, no mortality difference was found between the high- and low-altitude groups {hazard ratio [HR] 1.20 [95% confidence interval (CI) 0.89-1.62]}. After multivariable adjustment, receiving HD at high altitude was not significantly associated with higher mortality, but those with diabetes as the cause of ESKD had significantly higher mortality [HR 2.50 (95% CI 1.36-4.59)]. CONCLUSIONS: In Peru, patients receiving HD at high altitudes do not have mortality benefits.

Interrater reliability between in-person and telemedicine evaluations in obstructive sleep apnea.

STUDY OBJECTIVES: We examined how telemedicine evaluation compares to face-to-face evaluation in identifying risk for sleep-disordered breathing. METHODS: This was a randomized interrater reliability study of 90 participants referred to a university sleep center. Participants were evaluated by a clinician investigator seeing the patient in-person, then randomized to a second clinician investigator who performed a patient evaluation online via audio-video conferencing. The primary comparator was pretest probability for obstructive sleep apnea. RESULTS: The primary outcome comparing pretest probability for obstructive sleep apnea showed a weighted kappa value of 0.414 (standard error 0.090, P = .002), suggesting moderate agreement between the 2 raters. Kappa values of our secondary outcomes varied widely, but the kappa values were lower for physical exam findings compared to historical elements. CONCLUSIONS: Evaluation for pretest probability for obstructive sleep apnea via telemedicine has a moderate interrater correlation with in-person assessment. A low degree of interrater reliability for physical exam elements suggests telemedicine assessment for obstructive sleep apnea could be hampered by a suboptimal physical exam. Employing standardized scales for obstructive sleep apnea when performing telemedicine evaluations may help with risk-stratification and ultimately lead to more tailored clinical management.

Effect of gabapentin on hyperemesis gravidarum: a double-blind, randomized controlled trial.

BACKGROUND: Hyperemesis gravidarum is a disabling disease of nausea, vomiting, and undernutrition in early pregnancy for which there are no effective outpatient therapies. Poor weight gain in hyperemesis gravidarum is associated with several adverse fetal outcomes including preterm delivery, low birthweight, small for gestational age, low 5-minute Apgar scores, and neurodevelopmental delay. Gabapentin is most commonly used clinically for treating neuropathic pain but also substantially reduces chemotherapy-induced and postoperative nausea and vomiting. Pregnancy registry data have shown maternal first-trimester gabapentin monotherapy to be associated with a 1.2% rate of major congenital malformations among 659 infants, which compares favorably with the 1.6% to 2.2% major congenital malformation rate in the general population. Open-label gabapentin treatment in hyperemesis gravidarum was associated with reduced nausea and vomiting and improved oral nutrition. OBJECTIVE: This study aimed to determine whether gabapentin is more effective than standard-of-care therapy for treating hyperemesis gravidarum. STUDY DESIGN: A double-blind, randomized, multicenter trial was conducted among patients with medically refractory hyperemesis gravidarum requiring intravenous hydration. Patients were randomized (1:1) to either oral gabapentin (1800-2400 mg/d) or an active comparator of either oral ondansetron (24-32 mg/d) or oral metoclopramide (45-60 mg/d) for 7 days. Differences in Motherisk-pregnancy-unique quantification of nausea and emesis total scores between treatment groups averaged over days 5 to 7, using intention-to-treat principle employing a linear mixed-effects model adjusted for baseline Motherisk-pregnancy-unique quantification of nausea and emesis scores, which served as the primary endpoint. Secondary outcomes included Motherisk-pregnancy-unique quantification of nausea and emesis nausea and vomit and retch subscores, oral nutrition, global satisfaction of treatment, relief, desire to continue therapy, Nausea and Vomiting of Pregnancy Quality of Life, and Hyperemesis Gravidarum Pregnancy Termination Consideration. Adjustments for multiple comparisons were made employing the false discovery rate. RESULTS: A total of 31 patients with hyperemesis gravidarum were enrolled from October 2014 to May 2019. Among the 21 patients providing primary outcome data (12 assigned to gabapentin and 9 to the active comparator arm), 18 were enrolled as outpatients and all 21 were outpatients from days 5 to 7. The study groups' baseline characteristics were well matched. Gabapentin treatment provided a 52% greater reduction in days 5 to 7 baseline adjusted Motherisk-pregnancy-unique quantification of nausea and emesis total scores than treatment with active comparator (95% confidence interval, 16-88; P=.01). Most secondary outcomes also favored gabapentin over active comparator treatment including 46% and 49% decreases in baseline adjusted Motherisk-pregnancy-unique quantification of nausea and emesis nausea (95% confidence interval, 19-72; P=.005) and vomit and retch subscores (95% confidence interval, 21-77; P=.005), respectively; a 96% increase in baseline adjusted oral nutrition scores (95% confidence interval, 27-165; P=.01); and a 254% difference in global satisfaction of treatment (95% confidence interval, 48-459; P=.03). Relief (P=.06) and desire to continue therapy (P=.06) both showed trends favoring gabapentin treatment but Nausea and Vomiting of Pregnancy Quality of Life (P=.68) and Hyperemesis Gravidarum Pregnancy Termination Consideration (P=.58) did not. Adverse events were roughly equivalent between the groups. There were no serious adverse events. CONCLUSION: In this small trial, gabapentin was more effective than standard-of-care therapy for reducing nausea and vomiting and increasing oral nutrition and global satisfaction in outpatients with hyperemesis gravidarum. These data build on previous findings in other patient populations supporting gabapentin as a novel antinausea and antiemetic therapy and support further research on gabapentin for this challenging complication of pregnancy.

Impact of Patient-Centered Medical Home Transformation on Providers, Staff, and Quality.

The Patient-Centered Medical Home (PCMH) has become a widely implemented model to transform the delivery of care, but little evidence exists regarding the model's impact on providers, nurses, and staff. This study examined the impact of the PCMH model on (1) provider and staff satisfaction, (2) work-life balance, (3) teamwork, (4) professional experience, (5) patient care factors, and (6) quality outcomes. The authors confidentially surveyed physicians, advanced practice providers (APPs), nurses, care managers, and office staff in 2011 prior to implementation of the PCMH model and in 2016 after implementation at 34 primary care offices providing care to 171,045 patients. A total of 349 pre-PCMH implementation surveys (84% response rate) and 549 follow-up surveys (92% response rate) were received. Implementation of the PCMH model did not result in changes in provider, nurse, and staff responses to composite measures of satisfaction (P = 0.45), work-life balance (P = 0.68), teamwork (P = 0.26), patient care (P = 0.62), or professional experience (P = 0.14). Physicians and APPs experienced a negative, but mostly nonsignificant, change in all composite measures with implementation of the PCMH model. Quality markers improved for diabetes control HbA1c <8 (62.6% to 67.9%; P < 0.001), hypertension control (60.9% to 75.0%; P < 0.001), breast cancer screening (53.9% to 77.4%; P < 0.001), and colorectal cancer screening (43.9% to 70.3%; P < 0.001). Across a large primary care network, implementation of the PCMH model failed to improve overall satisfaction, work-life balance, teamwork, patient care, or professional experience. The model, combined with financial incentives, did result in improvements across multiple patient quality domains.

Peer Companionship for Mental Health of Older Adults in Primary Care: A Pragmatic, Nonblinded, Parallel-Group, Randomized Controlled Trial.

OBJECTIVES: To determine whether peer companionship delivered by an aging services agency to socially-disconnected older adult primary care patients was associated with improvement in suicidal ideation depression, anxiety, and psychological connectedness. DESIGN: Pragmatic, nonblinded, parallel-group, randomized controlled trial comparing peer companionship, The Senior Connection (TSC), to care-as-usual (CAU). SETTING: Lifespan, a nonmedical, community-based aging services agency. PARTICIPANTS: Adult primary care patients ages 60 years or older who endorsed feelings of loneliness or being a burden on others. INTERVENTION: TSC was delivered by Lifespan volunteers who provided supportive visits and phone calls in the subjects' homes. CAU involved no peer companion assignment. MEASUREMENTS: The primary outcome was suicidal ideation assessed by the Geriatric Suicide Ideation Scale; secondary outcomes were depression, anxiety, and feelings of belonging and being a burden on others. Data were collected at baseline, 3-, 6-, and 12-months. RESULTS: Subjects (55% female) had a mean age of 71 years. There was no difference between groups in change in suicidal ideation or belonging. Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01). CONCLUSIONS: TSC was superior to CAU for improving depression, anxiety, and perceived burden, but not suicidal ideation. Although effect sizes were small, the low-cost and nationwide availability of peer companionship justify further examination of its effectiveness and scalability in improving mental health outcomes of socially disconnected older adults.

Early childhood risk exposures and inflammation in early adolescence.

There is now reliable evidence that early psychosocial stress exposures are associated with behavioral health in children; the degree to which these same kinds of stress exposures predict physical health outcomes is not yet clear. We investigated the links between economic adversity, family and caregiving stress in early childhood and several markers of immune function in early adolescence. The sample is derived from the Family Life Project, a prospective longitudinal study of at-risk families. Socio-demographic and psychosocial risks have been assessed at regular intervals since the children were first assessed at 2 months of age. When the children were early adolescents, we conducted an in-depth health assessment of a subsample of families; blood samples were collected from venipuncture for interleukin(IL)-6, Tumor Necrosis Factor (TNF)-alpha, and C-reactive protein (CRP), as well as glucocorticoid resistance. Results indicated limited but reliable evidence of an association between early risk exposure and inflammation in adolescence. Specifically, caregiver depressive symptoms in early childhood predicted elevated CRP almost a decade later, and the prediction was significant after accounting for multiple covariates such as socio-economic adversity, health behaviors and body mass index. Our findings provide strong but limited evidence that early stress exposures may be associated with inflammation, suggesting one mechanism linking early stress exposure to compromised behavioral and somatic health.

Geriatric assessment and treatment outcomes in older adults with cancer receiving immune checkpoint inhibitors.

OBJECTIVES: Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, but outcomes in older adults are not well defined. We evaluated the associations of geriatric assessment (GA) domains with treatment-related outcomes in older adults with solid tumors receiving ICIs. METHODS: We performed a single-center, retrospective study of patients age ≥65 years diagnosed with solid tumors who received ICIs and were evaluated with a GA from January 2011 to April 2017. Using Wilcoxon rank sum test, we examined the associations of GA domains and treatment-related outcomes, including the number of ICI cycles received, best response, immune-related adverse events (irAEs), and hospitalizations during ICI treatment. RESULTS: We identified 28 patients (median age at ICI treatment = 78 years, range 66-93); 60% had Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥2; 39% had lung cancer; 89% had stage IV cancer; and 50% received pembrolizumab. Seventy-five percent had at least one GA domain impairment. Patients with any instrumental activities of daily living (IADL) impairment received fewer cycles of ICI (median: 2.0 vs. 7.0 cycles, p = 0.02). In this small sample, neither age nor GA domain measures were associated with best response, irAEs, or hospitalization during ICI treatment. CONCLUSIONS: Older adults treated with ICIs had a high prevalence of impairments in GA domains, and IADL impairments were associated with shorter duration of ICI treatment. Future prospective studies are needed to evaluate the role of the GA further in this vulnerable patient population in the immunotherapy era.

Ambulatory Training Program to Expand Procedural Skills in Primary Care.

INTRODUCTION: Outpatient procedures are an important component of primary care, yet few programs incorporate procedural training into their curriculum. We examined a 4-year procedural curriculum to improve understanding of ambulatory procedures and increase the number of procedures performed. METHODS: A total of 56 resident and 8 faculty physicians participated in a procedural curriculum directed at joint injections (knee, shoulder, elbow, trochanteric bursa, carpal tunnel, wrist, and ankle), subdermal contraceptive insertion/removal, skin biopsies, and ultrasound use in primary care. We administered annual surveys and used generalized estimating equations to model changes. RESULTS: Across the 4 years, there was an average 96% response rate. Mean comfort level with the indications for procedures increased for both resident (62.5 to 78.8; P < .0001) and faculty physicians (61.5 to 94.8; P < .0001). Similarly, mean comfort with performing procedures increased for both resident (32.1 to 62.3; P < .0001) and faculty physicians (42.2 to 85.4; P < .0001). Residents' comfort level performing procedures increased for all individual procedures measured. The mean number of procedures performed per year increased for resident (1.9 to 8.2; P < .0001) and faculty physicians (14.7 to 25.2; P = .087). CONCLUSIONS: A longitudinal ambulatory-based procedural curriculum can increase resident and faculty physician understanding and comfort performing primary-care-based procedures. This, in turn, increased the total number of procedures performed.

Comparison of the Michigan Hand Outcomes Questionnaire, Boston Carpal Tunnel Questionnaire, and PROMIS Instruments in Carpal Tunnel Syndrome.

PURPOSE: Patient-reported outcomes are important to assess improvement after surgery. Common instruments for carpal tunnel syndrome include the Michigan Hand Outcomes Questionnaire (MHQ) and Boston Carpal Tunnel Questionnaire (CTQ). The Patient-Reported Outcomes Measurement Information System (PROMIS) are newer measures. We evaluated how the PROMIS Pain Interference (PI) and Upper Extremity (UE) scores change after carpal tunnel release. METHODS: All adult patients with carpal tunnel syndrome treated surgically were asked to participate in this prospective study. PROMIS instruments, MHQ, and CTQ were completed by 101 patients. Estimated means and standard errors were calculated, and piecewise linear fixed effects regression models were applied to the data. Standardized response means were calculated for each outcome measure. RESULTS: The MHQ Total Score did not show a considerable change from the preoperative to 1-week postoperative visit but improved from the 1-week to 3-month postoperative visit (55 to 80). The CTQ Functional Status Score (FSS) worsened from 2.3 preoperatively to 2.6 at the 1-week postoperative visit before improving through the 3-month postoperative visit (1.6). PROMIS UE showed responsiveness similar to the CTQ FSS with a decline at the 1-week visit, 38 to 33, followed by improvement (45 at 3 mo). However, the standardized response mean values were greater for the CTQ FSS compared with PROMIS UE. The average administration time was shortest for PROMIS UE. The CTQ Symptom Severity Scale and MHQ Pain Scores showed improvements as early as the 1-week visit. The CTQ Symptom Severity Scale improved from 3.1 to 2.3, and MHQ Pain Scores improved from 55 to 46. PROMIS PI did not change at the 1-week visit but improved at 6 weeks and 3 months, from 56 to 52 and 49. The standardized response means for PROMIS PI achieved a large effect size only at 3 months. CONCLUSIONS: The CTQ FSS is more responsive than PROMIS UE and the MHQ, with the CTQ FSS showing the largest effect sizes. PROMIS PI does not show the responsiveness seen in the CTQ Symptom Severity Scale and MHQ Pain Score. PROMIS instruments require less time to complete. CLINICAL RELEVANCE: This study demonstrates the change in PROMIS scores after carpal tunnel release and how they compare with legacy outcome instruments.

CIED malfunction in patients receiving radiation is a rare event that could be detected by remote monitoring.

INTRODUCTION: An increasing number of patients with cardiac devices require radiation therapy for treatment of a variety of cancers. This study aimed to identify the incidence and predictors of cardiac implantable electronic devices (CIED) malfunction in a real-world population that has received radiation therapy. METHODS: This retrospective cohort study included 109 adult patients who received radiation therapy at the University of Rochester Medical Center, Radiation Oncology Department, between 2000 and 2015. Sixty patients had pacemakers and 49 had automatic implantable cardioverter defibrillators. Subjects received either high energy (16 MV) and/or low energy (6 MV) photon beams with or without electron beams (6-16 MeV). We included interrogations done from first day of radiation and up to 3 months' postradiation therapy. Outcomes analyzed were device-related malfunctions and device-related clinical events. Fisher's exact, Wilcoxon, and Kruskall-Wallis tests were used for bivariate analysis. Logistic regression with robust adjustment was used for multivariate analysis. RESULTS: We identified six device-related malfunctions. All events were minor and included partial settings reset leading to loss of historical data, pacing thresholds changes, lead impedance changes, and LV output increase. Two patients had device-related clinical events, including dyspnea and diaphragmatic-stimulation. In bivariate analysis, CIED malfunction was associated with CIED duration in situ. In multivariate analysis, there was no significant statistical association between adverse events and beam energy type, CIED location, or dose of radiation delivered to the target. CONCLUSIONS: CIED malfunctions are uncommon in real-world patients and associated with minor clinical events. In our cohort, remote CIED monitoring would have identified all events.

Defining Tip-Frenulum Length for Ankyloglossia and Its Impact on Breastfeeding: A Prospective Cohort Study.

OBJECTIVE: The purpose of this study was to investigate the normal lingual frenulum anatomy in newborns and to evaluate tip-frenulum distance as an objective diagnostic tool for identifying newborns at risk for anterior and posterior tongue tie and breastfeeding difficulty. MATERIALS AND METHODS: The distance from the tongue tip to the insertion of the lingual frenulum was measured in a group of 100 healthy newborns to establish normative data. The presence of a visible or palpable cord was noted. Inter-rater reliability was assessed. Breastfeeding surveys including a maternal pain scale and Infant Breastfeeding Assessment Tool (IBFAT) were administered on days of life 2 and 14 to determine whether these findings predict breastfeeding difficulty. RESULTS: Mean tip-frenulum length was 9.07 mm. Intraclass correlation coefficient between observers for tip-frenulum length was 0.82. A visible cord was identified in 21 subjects (21%). A palpable cord was identified in 59 subjects (59%). Unweighted κ coefficients for inter-rater reliability of visible and palpable cords were 0.91 and 0.47, respectively. Visible cord and shorter tip-frenulum distance were independently predictive of higher maternal pain scores. A positive correlation was identified between tip-frenulum length and IBFAT scores for mothers with two or more previous breastfed children. CONCLUSIONS: Tongue tip-frenulum length correlated with maternal nipple pain, and was useful as an objective tool for identifying newborns at risk for ankyloglossia. Maternal breastfeeding experience appears to be an important factor in the link between tongue anatomy and breastfeeding difficulty. The presence of a palpable cord was variable across examiners, and should be interpreted with caution when evaluating newborns for posterior tongue tie.

Validation of telephone-based behavioral assessments in aging services clients.

BACKGROUND: The Behavioral Health Laboratory (BHL), a telephone-based mental health assessment, is a cost-effective approach that can improve mental illness identification and management. The individual BHL instruments, which were originally designed to be administered in-person, have not yet been validated with an in-person BHL assessment. This study therefore aims to characterize the concordance between the BHL data gathered by telephone and in-person interviews. METHODS: A cross-sectional study was conducted with English-speaking aging services network (ASN) clients aged 60 years and older in Monroe County, NY who were randomized to a BHL interview either in-person (n = 55) or by telephone (n = 53). RESULTS: There was strong evidence of equivalence between telephone and in-person interviews for depressive disorders, generalized anxiety, panic disorder, drug misuse, psychosis, PTSD, mental illness symptom severity, and five of the six questions assessing suicidality. There was marginal equivalence in PHQ-9 total scores and one of the six questions assessing suicidal ideation, and no evidence of equivalence between interview modalities for assessing cognitive impairment. CONCLUSIONS: With a few exceptions, the BHL gathered nearly equivalent information via telephone as compared to in-person interviews. This suggests that the BHL may be a cost-effective approach appropriate for dissemination in a wide variety of settings including the ASN. Dissemination of the BHL has the potential to strengthen the linkages between primary care, mental healthcare, and social service providers and improve identification and management of those with late-life mental illness.

Inflammation investigated as a source of pharmacokinetic variability of atazanavir in AIDS Clinical Trials Group protocol A5224s.

BACKGROUND: Inflammation is associated with the downregulation of drug metabolizing enzymes and transporters. Thus, we investigated the chronic inflammatory state associated with HIV infection as a source of pharmacokinetic variability of atazanavir. We also explored the association of total bilirubin concentrations with markers of inflammation and endothelial activation. METHODS: Apparent oral clearance (CL/F) of atazanavir was estimated from plasma samples collected from participants in AIDS Clinical Trials Group Study A5202. Several inflammatory and endothelial activation biomarkers were measured at baseline and weeks 24 and 96 as part of metabolic substudy A5224s: high-sensitivity C-reactive protein (hsCRP), interleukin-6, tumour necrosis factor-α and its soluble receptors, soluble vascular cellular and intracellular adhesion molecules and total bilirubin. Statistical analysis was performed by a matrix of correlation coefficients between atazanavir CL/F and biomarker concentrations measured at week 24. The correlation between atazanavir clearance and percentage change in bilirubin from baseline to weeks 24 and 96, and between biomarkers and bilirubin concentrations at each week were also evaluated. RESULTS: Among 107 participants, there were no significant correlations observed between atazanavir CL/F and inflammatory and endothelial activation biomarkers measured at week 24 (P≥0.24). As expected, bilirubin increased with increasing exposure to atazanavir (rho=-0.25, P=0.01). Bilirubin concentrations were inversely correlated (P<0.01) with each of the biomarkers except hsCRP. CONCLUSIONS: Atazanavir CL/F did not correlate with the inflammatory biomarkers changes. Inflammatory-mediated inhibition of cytochrome P450 3A may have been attenuated due to atazanavir-associated increases of bilirubin, which has known anti-inflammatory properties.

Effectiveness of Corticosteroid Injections for Treatment of de Quervain's Tenosynovitis.

BACKGROUND: Although surgery can provide definitive treatment for de Quervain's tenosynovitis, nonoperative treatment could be preferable if symptoms are predictably relieved. We sought to determine the effectiveness of corticosteroid injections as treatment for de Quervain's tenosynovitis and to evaluate patient characteristics as predictors of treatment outcome. METHODS: A retrospective study was conducted using our institutional database International Classification of Disease, version 9 (ICD-9) code list for de Quervain's tenosynovitis. Treatment success was defined as relief of symptoms after 1 or 2 injections. Relief was defined as resolution or improvement to the extent that the patient did not seek further intervention. Failure was defined as a subsequent surgical release or a third injection. Logistic regression analyses were performed to look for univariate associations between patient demographics/comorbidities and risk of treatment failure. RESULTS: The treatment outcome of 222 limbs from 199 patients was studied. Of the 222 limbs, 73.4% (95% confidence interval [CI], 66.9%-79.1%) experienced treatment success within 2 injections, and 51.8% (95% CI, 45.0%-58.6%) experienced success after 1 injection. Body mass index (BMI) >30 and female sex were found to be significantly associated with treatment failure, with a 2.4-fold increase (95% CI, 1.02%-5.72%) in odds and 3.23 times greater (95% CI, 1.08%-9.67%) odds of failure, respectively. Although not reaching statistical significance, African American race, hypothyroidism, and carpal tunnel syndrome suggested increased odds of failure. CONCLUSIONS: This study indicates that corticosteroid injections are a useful treatment for de Quervain's tenosynovitis, leading to treatment success 73.4% of the time within 2 injections. This study also suggests that female sex and BMI >30 are associated with increased treatment failure.

Total Hip Arthroplasty for Femoral Neck Fractures: Improved Outcomes With Higher Hospital Volumes.

OBJECTIVES: To determine if hospital arthroplasty volume affects patient outcomes after undergoing total hip arthroplasty (THA) for displaced femoral neck fractures. METHODS: The Statewide Planning and Research Cooperative System database from the New York State Department of Health was used to group hospitals into quartiles based on overall THA volume from 2000 to 2010. The database was then queried to identify all patients undergoing THA specifically for femoral neck fracture during this time period. The data were analyzed to investigate outcomes between the 4 volume quartiles in 30-day and 1-year mortality, 1-year revision rate, and 90-day complication rate (readmission for dislocation, deep vein thrombosis, pulmonary embolism, prosthetic joint infection, or other complications related to arthroplasty in the treatment of femoral neck fractures with THA). RESULTS: Patients undergoing THA for femoral neck fracture at hospitals in the top volume quartile had significantly lower 30-day (0.9%) and 1-year (7.51%) mortality than all other volume quartiles. There were no significant differences on pairwise comparisons between the second, third, and fourth quartiles with regard to postoperative mortality. There was no significant difference in revision arthroplasty at 1 year between any of the volume quartiles. On Cox regression analysis, THA for fracture at the lowest volume (fourth) quartile [hazard ratio (HR), 1.91; P = 0.016, 95% confidence interval (CI), (1.13-3.25)], second lowest volume (third) quartile (HR, 2.01; P = 0.013, 95% CI, 1.16-3.5) and third lowest volume (second) quartile (HR, 2.13; P = 0.005, 95% CI, 1.26-3.62) were associated with increased risk for a 1-year postoperative mortality event. Hospital volume quartile was also a significant risk factor for increased 90-day complication (pulmonary embolism/deep vein thrombosis, acute dislocation, prosthetic joint infection) following THA for femoral neck fracture. Having surgery in the fourth quartile (HR, 2.71; P < 0.001, 95% CI, 1.7-4.31), third quartile (HR, 2.61; P < 0.001, 95% CI, 1.61-4.23), and second quartile (HR, 2.41; P < 0.001, 95% CI, 1.51-3.84), all were significant risk factors for increased 90-day complication risk. CONCLUSIONS: The results of this population-based study indicate that THA for femoral neck fractures at high-volume arthroplasty centers is associated with lower mortality and 90-day complication rates but does not influence 1-year revision rate. THA for femoral neck fractures at top arthroplasty volume quartile hospitals are performed on healthier patients more quickly. Patient health is a critical factor that influences mortality outcomes following THA for femoral neck fractures. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Effect of oral sodium bicarbonate on fibroblast growth factor-23 in patients with chronic kidney disease: a pilot study.

BACKGROUND: The regulation of fibroblast growth factor-23 (FGF23) secretion in patients with chronic kidney disease (CKD) is incompletely understood. An in vitro study showed that metabolic acidosis increased FGF23 in mouse bone. The objective of this study is to evaluate the effect of oral sodium bicarbonate on circulating FGF23 levels in patients with CKD. METHODS: This was a single-blind pilot study. Twenty adults with estimated glomerular filtration rate between 15-45 mL/min/1.73 m(2) and serum bicarbonate between 20-24 mEq/L were treated with placebo for 2 weeks, followed by increasing doses of oral sodium bicarbonate (0.3, 0.6 and 1.0 mEq/kg/day) in 2 week intervals for a total of 6 weeks. C-terminal FGF23 levels were measured at the initial visit, after 2 weeks of placebo and after 6 weeks of bicarbonate therapy. Wilcoxon matched-pairs signed-rank test was used to compare FGF23 before and after sodium bicarbonate. RESULTS: After 6 weeks of oral sodium bicarbonate, the median FGF23 increased significantly from 150.9 RU/mL (IQR 107.7-267.43) to 191.4 RU/mL (IQR 132.6-316.9) (p = 0.048) and this persisted after excluding participants who received activated vitamin D. CONCLUSIONS: FGF23 increased after short-term oral sodium bicarbonate therapy in patients with CKD and mild metabolic acidosis. It is unclear whether this was due to the alkalinizing effect of sodium bicarbonate or other factors. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov ( NCT00888290 ) on April 23, 2009.

Immunohistochemistry as a surrogate for molecular subtyping of gastric adenocarcinoma.

The Cancer Genome Atlas Research Network recently classified gastric adenocarcinoma into 4 molecular subtypes: Epstein-Barr virus-positive tumors, microsatellite-unstable tumors, tumors with chromosomal instability, and genomically stable tumors. We theorized that immunohistochemistry might be useful in similar categorization and that that HER2 expression might relate to subtype. We stained 104 gastric adenocarcinomas for MLH1, p53, and EBER in situ hybridization. We grouped them based on staining pattern and compared the groups. Cases were categorized as follows: group 1 (EBER positive), 7 cases (7%); group 2 (MLH1 deficient), 17 cases (16%); group 3 (aberrant p53 staining, EBER negative, retained MLH1), 40 cases (38%); group 4 (unremarkable staining), 40 cases (38%). This distribution was comparable to that found by the Research Network after accounting for the TP53 mutation rate in the chromosomal instability group. Group 1 patients had significantly longer follow-up times (median, 70 months versus 13 months for other groups; P = .0324). No group 2 cases overexpressed HER2. In group 3, 3 of 40 cases were HER2 immunohistochemistry positive, but 7 of 27 were HER2 positive by fluorescence in situ hybridization. Staining offers an efficient, reasonably accurate alternative for molecular subtyping of gastric adenocarcinoma, although some cases with chromosomal instability cannot be identified. These findings have potential prognostic and therapeutic implications.

Aortic anatomic severity grade correlates with resource utilization.

BACKGROUND: Potential cost effectiveness of endovascular aneurysm repair (EVAR) compared with open aortic repair (OAR) is offset by the use of intraoperative adjuncts (components) or late reinterventions. Anatomic severity grade (ASG) can be used preoperatively to assess abdominal aortic aneurysms, and provide a quantitative measure of anatomic complexity. The hypothesis of this study is that ASG is directly related to the use of intraoperative adjuncts and cost of aortic repair. METHODS: Patients who undergo elective OAR and EVAR for abdominal aortic aneurysms were identified over a consecutive 3-year period. ASG scores were calculated manually using three-dimensional reconstruction software by two blinded reviewers. Statistical analysis of cost data was performed using a log transformation. Regression analyses, with a continuous or dichotomous outcome, used a generalized estimating equations approach with the sandwich estimator, being robust with respect to deviations from model assumptions. RESULTS: One hundred forty patients were identified for analysis, n = 33 OAR and n = 107 EVAR. The mean total cost (± standard deviation) for OAR was per thousand (k) $38.3 ± 49.3, length of stay (LOS) 13.5 ± 14.2 days, ASG score 18.13 ± 3.78; for EVAR, mean total cost was k $24.7 ± 13.0 (P = .016), LOS 3.0 ± 4.4 days (P = .012), ASG score 15.9 ± 4.13 (P = .010). In patients who underwent EVAR, 25.2% required intraoperative adjuncts, and analysis of this group revealed a mean total cost of k $31.5 ± 15.9, ASG score 18.48 ± 3.72, and LOS 3.9 ± 4.5, which were significantly greater compared with cases without adjunctive procedures. An ASG score of ≥15 correlated with an increased propensity for requirement of intraoperative adjuncts; odds ratio, 5.75 (95% confidence interval, 1.82-18.19). ASG >15 was also associated with chronic kidney disease, end stage renal disease, hypertension, female sex, increased cost, and use of adjunctive procedures. CONCLUSIONS: Complex aneurysm anatomy correlates with increased total cost and need for adjunctive procedures during EVAR. Preoperative assessment with ASG scores can delineate patients at greater risk for increased resource use. Patient comorbid factors are associated with anatomic complexity defined according to ASG. A critical examination of the relationship between anatomic complexity and finances is required within the context of aggressive endovascular treatment strategies and shifts toward value-based reimbursement.

Distal Radioulnar Joint Reaction Force Following Ulnar Shortening: Diaphyseal Osteotomy Versus Wafer Resection.

PURPOSE: To compare how ulnar diaphyseal shortening and wafer resection affect distal radioulnar joint (DRUJ) joint reaction force (JRF) using a nondestructive method of measurement. Our hypothesis was that ulnar shortening osteotomy would increase DRUJ JRF more than wafer resection. METHODS: Eight fresh-frozen human cadaveric upper limbs were obtained. Under fluoroscopic guidance, a threaded pin was inserted into the lateral radius orthogonal to the DRUJ and a second pin was placed in the medial ulna coaxial to the radial pin. Each limb was mounted onto a mechanical tensile testing machine and a distracting force was applied across the DRUJ while force and displacement were simultaneously measured. Data sets were entered into a computer and a polynomial was generated and solved to determine the JRF. This process was repeated after ulnar diaphyseal osteotomy, ulnar re-lengthening, and ulnar wafer resection. The JRF was compared among the 4 conditions. RESULTS: Average baseline DRUJ JRF for the 8 arms increased significantly after diaphyseal ulnar shortening osteotomy (7.2 vs 10.3 N). Average JRF after re-lengthening the ulna and wafer resection was 6.9 and 6.7 N, respectively. There were no differences in JRF among baseline, re-lengthened, and wafer resection conditions. CONCLUSIONS: Distal radioulnar joint JRF increased significantly after ulnar diaphyseal shortening osteotomy and did not increase after ulnar wafer resection. CLINICAL RELEVANCE: Diaphyseal ulnar shortening osteotomy increases DRUJ JRF, which may lead to DRUJ arthrosis.