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.

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.

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.

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.

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.

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.

The Effect of the Epitendinous Suture on Gliding in a Cadaveric Model of Zone II Flexor Tendon Repair.

PURPOSE: We hypothesized that increasing core sutures (4-6) may be preferable in terms of gliding coefficient (GC) measurements when compared with adding an epitendinous suture to zone II flexor tendon repairs. We hypothesized that the inclusion of epitendinous suture in 2 standard repairs would contribute negatively to the GC of the repaired tendon. METHODS: Nineteen fresh-frozen cadaveric fingers were used for testing. We compared a control group (dissected digits without repair) and 4-strand or 6-strand core tendon repairs with and without epitendinous suture. Arc of motion was driven by direct loading, and digital images were acquired and analyzed. Outcomes were defined as the difference in GC between the native uninjured and the repaired state at each load. A linear mixed-model analysis was performed with comparisons between repairs to evaluate the statistically relevant differences between groups. RESULTS: The test of fixed effects in the linear model revealed that repair type and the use of epitendinous suture significantly affected the change in GC. The addition of an epitendinous suture produced a significant decrement in gliding regardless of repair type. CONCLUSIONS: There was significant improvement in GC with the omission of the epitendinous suture in both repair types (4- or 6-strand). CLINICAL RELEVANCE: The epitendinous suture used in this model resulted in poorer gliding of the repair, which may correspond with an expected increase in catching or triggering.

Caffeine consumption and risk of dyskinesia in CALM-PD.

BACKGROUND: Adenosine A2A receptor antagonists reduce or prevent the development of dyskinesia in animal models of levodopa-induced dyskinesia. METHODS: We examined the association between self-reported intake of the A2A receptor antagonist caffeine and time to dyskinesia in the Comparison of the Agonist Pramipexole with Levodopa on Motor Complications of Parkinson's Disease (CALM-PD) and CALM Cohort extension studies, using a Cox proportional hazards model adjusting for age, baseline Parkinson's severity, site, and initial treatment with pramipexole or levodopa. RESULTS: For subjects who consumed >12 ounces of coffee/day, the adjusted hazard ratio for the development of dyskinesia was 0.61 (95% CI, 0.37-1.01) compared with subjects who consumed <4 ounces/day. For subjects who consumed between 4 and 12 ounces/day, the adjusted hazard ratio was 0.73 (95% CI, 0.46-1.15; test for trend, P = .05). CONCLUSIONS: These results support the possibility that caffeine may reduce the likelihood of developing dyskinesia.

Effect of highly active antiretroviral therapy (HAART) and menopause on risk of progression of cervical dysplasia in human immune-deficiency virus- (HIV-) infected women.

BACKGROUND: More HIV-infected women are reaching older age and menopause, but there is limited information on cervical squamous intraepithelial lesions (SILs) on these women. METHODS: To assess the effect of HAART and menopause on SILs in HIV-infected women, we reviewed the results of Papanicolaou (Pap) tests obtained between 1991 and 2011 on 245 women. Progression to SILs was determined by comparing Pap test results. The association of HAART and transition to menopause on SILs was assessed using survival analysis. RESULTS: Women receiving HAART had a 52% reduced risk in the progression to SILs compared to women receiving any other antiretroviral regimen or no regimen (CI: 0.33-0.70, P = 0.0001). A greater increase of CD4(+) cell counts was associated with a greater reduction on the risk of progression to SILs. Menopausal women had a 70% higher risk of progression to SILs than premenopausal women (CI: 1.11-2.62, P < 0.0001), adjusting for HIV medications, CD4(+) count, duration of HIV infection, moderation effect of menopause by age, prior IV drug use, and smoking. CONCLUSION: HAART had a positive long-term effect on the progression to SILs. However, being younger and menopausal increases the risk of progression.

Full body photography in the massive weight loss population: an inquiry to optimize patient-centered care.

Medical photography of body contouring patients often requires complete nudity, placing patients in a vulnerable situation. We investigated patient perspectives on full body photography in an effort to better protect the patients and enhance comfort with the photography process. Sixty-five massive weight loss patients were identified who underwent body contouring surgery with full body photography. Photographs were taken at the time of initial consult, time of marking, and postoperatively. A retrospective chart review was performed to assess body mass indices and comorbidities, and a telephone survey inquired about several aspects of the photographic process. Fifty-six (86%) patients participated. Patients were more comfortable at the time of markings (P = 0.0004) and at the postoperative session (P = 0.0009). Patients' perception of positive body image increased after body contouring surgery (P < 0.0001). Patients who reported being comfortable at their initial session had a higher body mass index (P = 0.0027). Professionalism of the staff was rated as the most important aspect of the photographic process. Patients preferring a chaperone of the same sex tended to be less comfortable with the process (P = 0.015). Most patients preferred the surgeon as the photographer (P = 0.03). Patient comfort with full body photography improves quickly as they move through the surgical process. Maintaining professionalism is the most important factor in achieving patient trust and comfort. Limiting the number of observers in the room, providing explicit details of the photography process, and having at least 1 person of the same sex in the room can optimize patient safety and comfort.

Vitamin D deficiency and psychotic features in mentally ill adolescents: a cross-sectional study.

BACKGROUND: Vitamin D deficiency is a re-emerging epidemic, especially in minority populations. Vitamin D is crucial not only for bone health but for proper brain development and functioning. Low levels of vitamin D are associated with depression, seasonal affective disorder, and schizophrenia in adults, but little is known about vitamin D and mental health in the pediatric population. METHODS: One hundred four adolescents presenting for acute mental health treatment over a 16-month period were assessed for vitamin D status and the relationship of 25-OH vitamin D levels to severity of illness, defined by presence of psychotic features. RESULTS: Vitamin D deficiency (25-OH D levels <20 ng/ml) was present in 34%; vitamin D insufficiency (25-OH D levels 20-30 ng/ml) was present in 38%, with a remaining 28% in the normal range. Adolescents with psychotic features had lower vitamin D levels (20.4 ng/ml vs. 24.7 ng/ml; p=0.04, 1 df). The association for vitamin D deficiency and psychotic features was substantial (OR 3.5; 95% CI 1.4-8.9; p <0.009). Race was independently associated with vitamin D deficiency and independently associated with psychosis for those who were Asian or biracial vs. white (OR=3.8; 95% CI 1.1‒13.4; p<0.04). Race was no longer associated with psychosis when the results were adjusted for vitamin D level. CONCLUSIONS: Vitamin D deficiency and insufficiency are both highly prevalent in adolescents with severe mental illness. The preliminary associations between vitamin D deficiency and presence of psychotic features warrant further investigation as to whether vitamin D deficiency is a mediator of illness severity, result of illness severity, or both. Higher prevalence of vitamin D deficiency but no greater risk of psychosis in African Americans, if confirmed, may have special implications for health disparity and treatment outcome research.

Factors independently associated with complications and length of stay after hip arthroplasty: analysis of the National Surgical Quality Improvement Program.

By analysis of the American College of Surgeons National Surgical Quality Improvement Program database, we identified factors associated with postoperative complications and increased hospital stay after total hip arthroplasty in 4281 patients. There was a minor complication rate of 2.7%, a major complication rate of 4.2%, and a mortality rate of 0.26% within 30 days of the procedure. After adjusted analysis, obesity, preoperative anemia, and longer operative time were all associated with wound complications. Preoperative anemia, higher American Society of Anesthesiologists class, and prolonged operative time were associated with development of a major complication. A predischarge major complication resulted in an increased length of stay of 6.248 days (±0.286, P < .0001). One in 25 hip arthroplasty patients developed a major postoperative complication, and 1 in 16, a medical complication after elective hip arthroplasty.

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).

Smoking in dialysis patients: a systematic review and meta-analysis of mortality and cardiovascular morbidity.

BACKGROUND: Cigarette smoking is associated with increased cardiovascular morbidity and mortality in the general population, but the effect of smoking on these outcomes in the dialysis population is less well studied. STUDY DESIGN: Systematic review and meta-analysis of cohort studies. SETTING & POPULATION: Adults treated with long-term hemodialysis or peritoneal dialysis. SELECTION CRITERIA FOR INCLUDED STUDIES: Cohort studies of unselected dialysis patients reporting the association between smoking status and cardiovascular morbidity and/or mortality. PREDICTOR: Smoking status (determined using patient report). OUTCOMES: (1) All-cause or cardiovascular mortality; (2) incident cardiovascular events. RESULTS: We identified 34 studies that fulfilled all inclusion criteria. Of these, 26 studies provided data for smoking and mortality and 10 (n = 6,538) were included in a meta-analysis. The pooled HR for all-cause mortality in smokers compared with nonsmokers was 1.65 (95% CI, 1.26-2.14; P < 0.001). 11 studies provided data for smoking and incident cardiovascular events; 5 (pooled n = 845) were included in a meta-analysis. The pooled HR for composite cardiovascular events in smokers compared with nonsmokers was 1.01 (95% CI, 0.98-1.05; P = 0.4). LIMITATIONS: Data for these meta-analyses were heterogeneous. Few individual studies assessed smoking as the primary variable of interest. CONCLUSIONS: Active smoking is associated with a significant increase in all-cause mortality in dialysis patients, although there was no corresponding increased risk of cardiovascular events.

A laparoscopic approach does reduce short-term complications in patients undergoing ileal pouch-anal anastomosis.

BACKGROUND: Studies to date examining the impact of laparoscopy in the IPAA have failed to demonstrate a significant, consistent benefit in terms of a reduction in short-term morbidity or length of stay. OBJECTIVE: The aim of this study was to establish the impact of the operative approach (laparoscopic or open) on outcomes after IPAA formation. DESIGN, SETTING, AND PATIENTS: With use of the American College of Surgeons National Surgical Quality Improvement Program participant use file (2005-2008), the records of patients who underwent open or laparoscopic IPAA with diverting ileostomy were examined. MAIN OUTCOME MEASURES: Risk-adjusted 30-day outcomes and length of stay were assessed by use of regression modeling, adjusting for patient characteristics, comorbidities, and operative approach. RESULTS: Six hundred seventy-six cases were included, of which 339 (50.1%) were laparoscopic procedures. After adjustment, a laparoscopic approach was associated with a lower rate of major (OR = 0.67, 95% CI: 0.45-0.99, P = .04) and minor (OR = 0.44, 95% CI: 0.27-0.70, P = .01) complications. Laparoscopy was not associated with a significant reduction in length of postoperative stay compared with open pouch formation (laparoscopic vs open approach, -0.05 ± 0.30 d (P = .87)). LIMITATIONS: The sampling strategy used by the National Surgical Quality Improvement Program means that only a proportion of all relevant cases would have been analyzed and no data are available about the potential impact of surgeon experience on outcome. CONCLUSIONS: A laparoscopic approach to ileal pouch formation was associated with a significant reduction in both major and minor complications compared with the traditional open approach. Given the high financial costs associated with complications arising from this procedure, this study provides support for the adoption of the laparoscopic approach in the formation of an IPAA.

Laparoscopic appendectomy is safe and efficacious for the elderly: an analysis using the National Surgical Quality Improvement Project database.

BACKGROUND: Despite increasing use of laparoscopic appendectomy, data demonstrating outcomes of this technique exclusively among the elderly population are scarce. This study aimed to compare 30-day postoperative morbidity and length of hospital stay among elderly patients after appendectomy. METHODS: Appendicitis patients older than 65 years were extracted from the National Surgical Quality Improvement Project (NSQIP) database. Demographics and rates of complications for patients undergoing open and laparoscopic appendectomies were compared. Uni- and multivariate analyses adjusted for differences between groups compared the end points of major and minor complications as well as the days of hospital stay after initial surgery. RESULTS: A total of 3,335 patients underwent appendectomy, with 2,235 patients (67%) receiving a laparoscopic procedure. The open appendectomy patients were significantly older and more likely to have various preoperative comorbidities (p<0.05). No difference in median operative time between the two techniques was found. Both required 51 min (p=0.11). The open cases had higher rates of both major and minor postoperative complications than the laparoscopic cases (p<0.0001), both overall and before discharge. Multivariate analysis showed no association between operative approach and major complications, and a reduced risk of minor complications with laparoscopy. Length of surgical stay was longer for the open group than for the laparoscopically treated group (median, 4 days vs 2 days; p<0.05). After adjustment, laparoscopy still was significantly associated with a shorter hospital stay than open appendectomy (p<0.0001). CONCLUSIONS: Laparoscopic appendectomy is a safe procedure for elderly patients. During the 30-day postoperative period, no correlation with major complications was found, and the findings showed a beneficial association with regard to minor complications. After adjustment for perioperative factors, laparoscopy is associated with a shorter hospital stay than open appendectomy.

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.

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.