Comparing the Efficacy and Safety of Galcanezumab Versus Rimegepant for Prevention of Episodic Migraine: Results from a Randomized, Controlled Clinical Trial.

INTRODUCTION: There have been no prior trials directly comparing the efficacy of different calcitonin gene-related peptide (CGRP) antagonists for migraine prevention. Reported are the results from the first head-to-head study of two CGRP antagonists, galcanezumab (monoclonal antibody) versus rimegepant (gepant), for the prevention of episodic migraine. METHODS: In this 3-month, double-blind, double-dummy study, participants were randomized (1:1) to subcutaneous (SC) galcanezumab 120 mg per month (after a 240 mg loading dose) and a placebo oral disintegrating tablet (ODT) every other day (q.o.d.) or to rimegepant 75 mg ODT q.o.d. and a monthly SC placebo. The primary endpoint was the proportion of participants with a ≥ 50% reduction in migraine headache days per month from baseline across the 3-month double-blind treatment period. Key secondary endpoints were overall mean change from baseline in: migraine headache days per month across 3 months and at month 3, 2, and 1; migraine headache days per month with acute migraine medication use; Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive domain score at month 3; and a ≥ 75% and 100% reduction from baseline in migraine headache days per month across 3 months. RESULTS: Of 580 randomized participants (galcanezumab: 287, rimegepant: 293; mean age: 42 years), 83% were female and 81% Caucasian. Galcanezumab was not superior to rimegepant in achieving a ≥ 50% reduction from baseline in migraine headache days per month (62% versus 61% respectively; P = 0.70). Given the pre-specified multiple testing procedure, key secondary endpoints cannot be considered statistically significant. Overall, treatment-emergent adverse events were reported by 21% of participants, with no significant differences between study intervention groups. CONCLUSIONS: Galcanezumab was not superior to rimegepant for the primary endpoint; however, both interventions demonstrated efficacy as preventive treatments in participants with episodic migraine. The efficacy and safety profiles observed in galcanezumab-treated participants were consistent with previous studies. TRIAL REGISTRATION: ClinTrials.gov-NCT05127486 (I5Q-MC-CGBD).

Galcanezumab and rimegepant are preventive treatments for episodic migraine. The goal of this study was to compare the efficacy of galcanezumab and rimegepant in reducing the number of monthly migraine headaches and to determine if galcanezumab was better than rimegepant. The study provides important information to doctors and their patients when making treatment decisions.People with episodic migraine were assigned to the galcanezumab (given as an injection under the skin) or rimegepant (given as a tablet that dissolves in the mouth) group and treated for 3 months. The doctor and the patient did not know which group they were assigned to, and to keep it unknown to both, people in the galcanezumab group got an injection with real medicine and a fake tablet, and people in the rimegepant group got a tablet with real medicine and a fake injection. The researchers wanted to know how many people in each group had at least a 50% reduction in their monthly migraine headaches.Of the 580 people in the study, 287 were assigned to galcanezumab and 293 to rimegepant. In both groups, most were female and white. After 3 months of treatment, 62% of the people in the galcanezumab group and 61% of people in the rimegepant group had at least a 50% reduction in monthly migraine headaches. Both treatments were effective, but galcanezumab was not better than rimegepant. About 20% of the people in each treatment group had a side effect from the medication, and most were mild or moderate in severity.

Returning to sexual stigma: post-trafficking lives.

This article is concerned with returning to sexual stigma in two key respects. First, it prompts a return to the conceptual understanding of sexual stigma and makes an important contribution to critiques of the individualized frameworks that have dominated much of the literature on stigma to date, through a critical analysis of sexual stigma as a collective process at different scales and locations. Second, using empirical data from a qualitative study of post-trafficking experiences of women in Nepal as a case study to develop theoretical understandings of the production of stigma, it explores modalities of sexualized stigma encountered on return from trafficking situations. Within the trafficking literature there has been very little attention to what happens after trafficking. This article addresses this gap in focusing on lives post-trafficking and, in addition, contributes to the limited research on trafficking in Nepal.

Outcomes of Care for Ischemic Heart Disease and Chronic Heart Failure in the Veterans Health Administration.

Importance: The Department of Veterans Affairs (VA) operates a nationwide system of hospitals and hospital-affiliated clinics, providing health care to more than 2 million veterans with cardiovascular disease. While data permitting hospital comparisons of the outcomes of acute cardiovascular care (eg, myocardial infarction) are publicly available, little is known about variation across VA medical centers (VAMCs) in outcomes of care for populations of patients with chronic, high-risk cardiovascular conditions. Objective: To determine whether there are substantial differences in cardiovascular outcomes across VAMCs. Design, Setting, and Participants: Retrospective cohort study comprising 138 VA hospitals and each hospital's affiliated outpatient clinics. Patients were identified who received VA inpatient or outpatient care between 2010 and 2014. Separate cohorts were constructed for patients diagnosed as having either ischemic heart disease (IHD) or chronic heart failure (CHF). The data were analyzed between June 24, 2015, and November 21, 2017. Exposures: Hierarchical linear models with VAMC-level random effects were estimated to compare risk-standardized mortality rates for IHD and for CHF across 138 VAMCs. Mortality estimates were risk standardized using a wide array of patient-level covariates derived from both VA and Medicare health care encounters. Main Outcomes and Measures: All-cause mortality. Results: The cohorts comprised 930 079 veterans with IHD and 348 015 veterans with CHF; both cohorts had a mean age of 77 years and were predominantly white (IHD, n = 822 665 [89%] and CHF, n = 287 871 [83%]) and male (IHD, n = 916 684 [99%] and CHF n = 341 352 [98%]). The VA-wide crude annual mortality rate was 7.4% for IHD and 14.5% for CHF. For IHD, VAMCs' risk-standardized mortality varied from 5.5% (95% CI, 5.2%-5.7%) to 9.4% (95% CI, 9.0%-9.9%) (P < .001 for the difference). For CHF, VAMCs' risk-standardized mortality varied from 11.1% (95% CI, 10.3%-12.1%) to 18.9% (95% CI, 18.3%-19.5%) (P < .001 for the difference). Twenty-nine VAMCs had IHD mortality rates that significantly exceeded the national mean, while 35 VAMCs had CHF mortality rates that significantly exceeded the national mean. Veterans Affairs medical centers' mortality rates among their IHD and CHF populations were not associated with 30-day mortality rates for myocardial infarction (R2 = 0.01; P = .35) and weakly associated with hospitalized heart failure 30-day mortality (R2 = 0.16; P < .001) and the VA's star rating system (R2 = 0.06; P = .005). Conclusions and Relevance: Risk-standardized mortality rates for IHD and CHF varied widely across the VA health system, and this variation was not well explained by differences in demographics or comorbidities. This variation may signal substantial differences in the quality of cardiovascular care between VAMCs.

Rethinking Sexual Citizenship.

Over the last two decades sexuality has emerged as a key theme in debates about citizenship, leading to the development of the concept of sexual citizenship. This article reviews this literature and identifies four main areas of critical framing: work that contests the significance of sexuality to citizenship; critiques that focus on the possibilities and limitations of mobilising the language of citizenship in sexual politics; analyses of sexual citizenship in relation to nationalisms and border making; and literature that critically examines western constructions of sexuality and sexual politics underpinning understandings of sexual citizenship. In order to progress the field theoretically, the article seeks to extend critiques of sexual citizenship focusing on two key aspects of its construction: the sexual citizen-subject and spaces of sexual citizenship. It argues for a critical rethink that encompasses a de-centring of a 'western-centric' focus in order to advance understandings of how sexual citizenship operates both in the Global North and South.

Effect of a Decision Aid on Access to Total Knee Replacement for Black Patients With Osteoarthritis of the Knee: A Randomized Clinical Trial.

Importance: Black patients with advanced osteoarthritis (OA) of the knee are significantly less likely than white patients to undergo surgery. No strategies have been proved to improve access to surgery for black patients with end-stage OA of the knee. Objective: To assess whether a decision aid improves access to total knee replacement (TKR) surgery for black patients with OA of the knee. Design, Setting, and Participants: In a randomized clinical trial, 336 eligible participants who self-identified as black and 50 years or older with chronic and frequent knee pain, a Western Ontario McMaster Universities Osteoarthritis Index score of at least 39, and radiographic evidence of OA of the knee were recruited from December 1, 2010, to May 31, 2014, at 3 medical centers. Exclusion criteria were history of major joint replacement, terminal illness, inflammatory arthritis, prosthetic leg, cognitive impairment, lack of a telephone, or contraindications to elective replacement surgery. Data were analyzed on a per-protocol and intention-to-treat (ITT) basis. Exposure: Access to a decision aid for OA of the knee, a 40-minute video that describes the risks and benefits of TKR surgery. Main Outcomes and Measures: Receipt of TKR surgery within 12 months and/or a recommendation for TKR surgery from an orthopedic surgeon within 6 months after the intervention. Results: Among 336 patients (101 men [30.1%]; 235 women [69.9%]; mean [SD] age, 59.1 [7.2] years) randomized to the intervention or control group, 13 of 168 controls (7.7%) and 25 of 168 intervention patients (14.9%) underwent TKR within 12 months (P = .04). These changes represent a 70% increase in the TKR rate, which increased by 86% (11 of 154 [7.1%] vs 23 of 150 [15.3%]; P = .02) in the per-protocol sample. Twenty-six controls (15.5%) and 34 intervention patients (20.2%) in the ITT analysis received a recommendation for surgery within 6 months (P = .25). The difference in the surgery recommendation rate between the controls (24 of 154 [15.6%]) and the intervention group (31 of 150 [20.7%]) in the per-protocol analysis also was not statistically significant (P = .25). Adjustment for study site yielded similar results: for receipt of TKR at 12 months, adjusted ORs were 2.10 (95% CI, 1.04-4.27) for the ITT analysis and 2.39 (95% CI, 1.12-5.10) for the per-protocol analysis; for recommendation of TKR at 6 months, 1.39 (95% CI, 0.79-2.44) and 1.41 (95% CI, 0.78-2.55). Conclusions and Relevance: A decision aid increased rates of TKR among black patients. However, rates of recommendation for surgery did not differ significantly. A patient-centered counseling and educational intervention may help to address racial variations in the use of TKR for the management of end-stage OA of the knee. Trial Registration: clinicaltrials.gov Identifer: NCT01851785.

Women and citizenship post-trafficking: the case of Nepal.

This article analyses the relationship between gender, sexuality and citizenship embedded in models of citizenship in the Global South, specifically in South Asia, and the meanings associated with having - or not having - citizenship. It does this through an examination of women's access to citizenship in Nepal in the context of the construction of the emergent nation state in the 'new' Nepal 'post-conflict'. Our analysis explores gendered and sexualized constructions of citizenship in this context through a specific focus on women who have experienced trafficking, and are beginning to organize around rights to sustainable livelihoods and actively lobby for changes in citizenship rules which discriminate against women. Building from this, in the final section we consider important implications of this analysis of post-trafficking experiences for debates about gender, sexuality and citizenship more broadly.

Does a Patient-centered Educational Intervention Affect African-American Access to Knee Replacement? A Randomized Trial.

BACKGROUND: A TKA is the most effective and cost-effective surgical option for moderate to severe osteoarthritis (OA) of the knee. Yet, black patients are less willing to undergo knee replacement surgery than white patients. Decision aids help people understand treatment options and consider the personal importance of possible benefits and harms of treatments, including TKA. QUESTIONS/PURPOSES: We asked: (1) Does a patient-centered intervention consisting of a decision aid for knee OA and motivational interviewing improve the proportion of referrals of blacks with knee OA to orthopaedic surgery? (2) Does the intervention increase patients' willingness to undergo TKA? METHODS: Adults who self-identified as black who were at least 50 years old with moderate to severe knee OA were enrolled from urban primary care clinics in a two-group randomized, controlled trial. A total of 1253 patients were screened for eligibility, and 760 were excluded for not meeting inclusion criteria, declining to participate, or other reasons. Four hundred ninety-three patients were randomized and completed the intervention; three had missing referral data at followup. The mean age of the patients was 61 years, and 51% were women. The majority had an annual household income less than USD 15,000. Participants in the treatment group were shown a decision-aid video and had a brief session with a trained counselor in motivational interviewing. Participants in the control group received an educational booklet about OA that did not mention joint replacement. The two groups had comparable demographic and socioeconomic characteristics. The primary outcome was referral to orthopaedic surgery 12 months after treatment exposure. Receipt of referral was defined as the receipt of a recommendation or prescription from a primary care provider for orthopaedic evaluation. The secondary outcome was change in patient willingness to undergo TKA based on patient self-report. RESULTS: The odds of receiving a referral to orthopaedic surgery did not differ between the two study groups (36%, 90 of 253 of the control group; 32%, 76 of 240 of the treatment group; odds ratio [OR], 0.81; 95% CI, 0.56-1.18; p = 0.277). At 2 weeks followup, there was no difference between the treatment and the control groups in terms of increased willingness to consider TKA relative to baseline (34%, 67 of 200 patients in the treatment group; 33%, 68 of 208 patients in the control group; OR, 1.06; p = 0.779). At 12 months followup, the percent increase in willingness to undergo TKA still did not differ between patients in the treatment and control groups (29%, 49 of 174 in the treatment group; 27%, 51 of 191 in the control group; OR, 1.10; p = 0.679). CONCLUSION: A combination decision aid and motivational interviewing strategy was no better than an educational pamphlet in improving patients' preferences toward joint replacement surgery for knee OA. The type of intervention treatment also did not affect access to surgical evaluation. Other tools that target patient knowledge, beliefs, and attitudes regarding surgical treatments for OA may be further developed and tested in the future. LEVEL OF EVIDENCE: Level I, therapeutic study.

Remote Ambulatory Management of Veterans with Obstructive Sleep Apnea.

STUDY OBJECTIVES: Despite significant medical sequelae of obstructive sleep apnea (OSA), the condition remains undiagnosed and untreated in many affected individuals. We explored the feasibility of a comprehensive, telemedicine-based OSA management pathway in a community-based Veteran cohort. METHODS: This prospective, parallel-group randomized pilot study assessed feasibility of a telemedicine-based pathway for OSA evaluation and management in comparison to a more traditional, in-person care model. The study included 60 Veterans at the Philadelphia Veterans Affairs Medical Center and two affiliated community-based outpatient clinics. Telemedicine pathway feasibility, acceptability, and outcomes were assessed through a variety of quantitative (Functional Outcomes of Sleep Questionnaire, dropout rates, positive airway pressure [PAP] adherence rates, participant satisfaction ratings) and qualitative (verbal feedback) metrics. RESULTS: There was no significant difference in functional outcome changes, patient satisfaction, dropout rates, or objectively measured PAP adherence between groups after 3 months of treatment. Telemedicine participants showed greater improvement in mental health scores, and their feedback was overwhelmingly positive. CONCLUSIONS: Our pilot study suggests that telemedicine-based management of OSA patients is feasible in terms of patient functional outcomes and overall satisfaction with care. Future studies should include larger populations to further elucidate these findings while assessing provider- and patient-related cost effectiveness.

Race, Rehabilitation, and 30-Day Readmission After Elective Total Knee Arthroplasty.

INTRODUCTION: To examine racial variations in access to postacute care (PAC) and rehabilitation (Rehab) services following elective total knee arthroplasty and whether where patients go after surgery for PAC/Rehab is associated with 30-day readmission to acute care facility. MATERIALS AND METHODS: Sample consisted of 129 522 patients discharged from 169 hospitals in the State of Pennsylvania between fiscal years 2008 and 2012. We used multinomial regression models to assess the relationship between patient race and discharge destination after surgery, for patients aged 18 to 64 years and for those aged 65 and older. We used multivariable (MV) regression and propensity score (PS) approaches to examine the relationship between patient discharge destination after surgery for PAC/Rehab and 30-day readmission, controlling for key individual- and facility-level factors. RESULTS: Lower proportions of younger patients compared to those older than 65 were discharged to inpatient rehabilitation facilities (IRFs; 5.8% vs 12.6%, respectively) and skilled nursing facilities (SNFs; 15.2% vs 32.7%, respectively) compared to home-based Rehab (self-care; 23.3% vs 14.2%, respectively). Compared to whites, African American patients had significantly higher odds of discharge to IRF (age < 65, odds ratio = 2.04; age ≥ 65, odds ratio = 1.64) and to SNF (age < 65, odds ratio = 2.86; age ≥ 65, odds ratio = 2.19) and discharge to home care in patients younger than 65 years (odds ratio = 1.31). The odds of 30-day readmission among patients discharged to an IRF (MV odds ratio = 7.76; PS odds ratio = 8.34) and SNF (MV odds ratio = 2.01; PS odds ratio = 1.83) were significantly higher in comparison to patients discharged home with self-care. CONCLUSION: African American patients with knee replacement are more likely to be discharged to inpatient Rehab settings following surgery. Inpatient Rehab is significantly associated with 30-day readmission to acute care facility.

Comparative effectiveness of high-dose versus standard-dose influenza vaccination in community-dwelling veterans.

BACKGROUND: Influenza is a significant cause of morbidity and mortality in older adults. High-dose (HD) trivalent inactivated vaccine has increased immunogenicity in older adults compared with standard-dose (SD) vaccine. We assessed the relative effectiveness of HD influenza vaccination (vs SD influenza vaccination). METHODS: We conducted a retrospective cohort study among patients who receive primary care at Veteran Health Administration (VHA) medical centers, and who received influenza vaccine in the 2010-2011 influenza season. The primary outcome was hospitalization for influenza or pneumonia. We also conducted an analysis in subgroups defined by age. RESULTS: We evaluated 25 714 patients who received HD vaccine and 139 511 who received SD vaccine in 23 VHA medical centers. The rate of hospitalization for influenza or pneumonia was 0.3% in both groups in the influenza season. After accounting for patient characteristics in propensity-adjusted analyses, the risk of hospitalization for influenza or pneumonia was not significantly lower among patients receiving HD vaccine vs those receiving SD vaccine (risk ratio, 0.98; 95% confidence interval, .68-1.40). In the subgroup of patients ≥85 years of age, receiving HD (compared with SD) vaccine was associated with lower rates of hospitalization for influenza or pneumonia. CONCLUSIONS: HD vaccine was not found to be more effective than SD vaccine in protecting against hospitalization for influenza or pneumonia; however, we found a protective effect in the oldest subgroup of patients. Additional studies are needed to evaluate the effectiveness of HD vaccine.

Financial incentives for completion of fecal occult blood tests among veterans: a 2-stage, pragmatic, cluster, randomized, controlled trial.

BACKGROUND: Rates of patient completion of fecal occult blood tests (FOBTs) are often low. OBJECTIVE: To examine whether financial incentives increase rates of FOBT completion. DESIGN: A 2-stage, parallel-design, pragmatic, cluster, randomized, controlled trial with clustering by clinic day (ClinicalTrials.gov: NCT01516489). SETTING: Primary care clinic of the Philadelphia Veterans Affairs Medical Center. PATIENTS: 1549 patients who were prescribed an FOBT (unique samples of 713 patients for stage 1 and 836 patients for stage 2). INTERVENTION: In stage 1, patients were assigned to usual care or receipt of $5, $10, or $20 for FOBT completion. In stage 2, different patients were assigned to usual care or receipt of $5, a 1 in 10 chance of $50, or entry into a $500 raffle for FOBT completion. MEASUREMENTS: Primary outcome was FOBT completion within 30 days. Preplanned subgroup analyses examined 30-day FOBT completion by previous nonadherence to a prescribed FOBT. RESULTS: In stage 1, none of the incentives increased rates of FOBT completion. In stage 2, a 1 in 10 chance of $50 increased FOBT completion compared with usual care (between-group difference, 19.6% [95% CI, 10.7% to 28.6%]; P < 0.001) but a $5 fixed payment and entry into a raffle for $500 did not. None of the incentives were more effective among patients who had previously been nonadherent to an FOBT than among patients who had previously completed an FOBT. LIMITATIONS: Single Veterans Affairs medical center setting, short follow-up, use of 3-sample rather than 1-sample immunochemical FOBTs, limited power to detect small effects of incentives, inability to evaluate cost-effectiveness. CONCLUSION: A 1 in 10 chance of receiving $50 was effective at increasing rates of FOBT completion, but 5 other tested incentives were not. PRIMARY FUNDING SOURCE: Veterans Affairs Center for Health Equity Research and Promotion.

Family involvement at the end-of-life and receipt of quality care.

CONTEXT: Most patients will lose decision-making capacity at the end of life. Little is known about the quality of care received by patients who have family involved in their care. OBJECTIVES: To evaluate differences in the receipt of quality end-of-life care for patients who died with and without family involvement. METHODS: We retrospectively reviewed the charts of 34,290 decedents from 146 acute and long-term care Veterans Affairs facilities between 2010 and 2011. Outcomes included: (1) palliative care consult, (2) chaplain visit, and 3) death in an inpatient hospice or palliative care unit. We also assessed "do not resuscitate" (DNR) orders. Family involvement was defined as documented discussions with the health care team in the last month of life. We used logistic regression adjusted for demographics, comorbidity, and clustered by facility. For chaplain visit, hospice or palliative care unit death, and DNR, we additionally adjusted for palliative care consults. RESULTS: Mean (SD) age was 74 (±12) years, 98% were men, and 19% were nonwhite. Most decedents (94.2%) had involved family. Veterans with involved family were more likely to have had a palliative care consult, adjusted odds ratio (AOR) 4.31 (95% CI 3.90-4.76); a chaplain visit, AOR 1.18 (95% CI 1.07-1.31); and a DNR order, AOR 4.59 (95% CI 4.08-5.16) but not more likely to die in a hospice or palliative care unit. CONCLUSION: Family involvement at the end of life is associated with receipt of palliative care consultation and a chaplain visit and a higher likelihood of a DNR order. Clinicians should support early advance care planning for vulnerable patients who may lack family or friends.

A nationwide study comparing end-of-life care for men and women veterans.

BACKGROUND: The quality of end-of-life (EOL) care at Veterans Affairs Medical Centers (VAMC) has improved. To date, however, the quality and outcomes of end-of-life care delivered to women veterans have not been examined. OBJECTIVE: The goal of this study was to evaluate gender differences in the quality of EOL care received by patients in VAMCs nationwide. DESIGN: The study was conducted via retrospective medical chart review and telephone survey with next of kin of recently deceased inpatients. SETTING/SUBJECTS: The chart review included records for all patients who died in acute and long-term care units in 145 VAMCs nationwide (n=36,618). For the survey, the documented next of kin were invited to respond on behalf of the deceased veteran; a total of 25,638 next of kin completed the survey. MEASUREMENTS: Chart review measures included five indicators of optimal end-of-life care. Bereaved family survey items included one global and nine specific items (e.g., bereavement care, pain management) describing care in the last month of life. RESULTS: Receipt of optimal end-of-life care did not differ significantly between women and men with respect to frequency of discussion of treatment goals with a family member, receipt of palliative consult, bereavement contact, and chaplain contact with a family member. Family members of women were more likely than those of men to report that the overall care provided to the veteran had been "excellent" (adjusted proportions: 63% versus 56%; odds ratio (OR)=1.33; 95% confidence interval (CI) 1.10-1.61; p=0.003). CONCLUSIONS: In this nationwide study of all inpatient deaths in VAMCs, women received comparable and on some metrics better quality EOL care than that received by male patients.

Sex and surgical outcomes and mortality after primary total knee arthroplasty: a risk-adjusted analysis.

OBJECTIVE: Total knee arthroplasty (TKA) is a widely utilized and effective treatment option for end-stage knee osteoarthritis (OA). Knee OA is more prevalent among women compared to men, but there are limited data on the sex differences in surgical outcomes after primary TKA. METHODS: Our sample consisted of all primary TKAs performed in Pennsylvania during the fiscal year 2002. We used International Classification of Diseases, Ninth Revision, Clinical Modification codes to identify major complications and surgical revision. We used mixed-effects logistic regression models to examine the associations between sex and all-cause mortality, readmissions, and major surgical complications. We used proportional hazards models to assess the risk of surgical revision after index arthroplasty. We adjusted for race, age, hospital teaching status, hospital procedure volume, insurance status, and risk of mortality. RESULTS: In 17,994 primary TKAs, there were 46 and 220 deaths at 30 days and 1 year, respectively. Compared to women, men had higher adjusted odds of 1-year mortality (odds ratio [OR] 1.48 [95% confidence interval (95% CI) 1.13-1.94]) after primary TKA. The overall odds of most major 30-day complications did not differ by sex except for surgical wound infections, which were higher in men compared to women (OR 1.31 [95% CI 1.08-1.60]); 30-day readmission was higher in men (OR 1.25 [95% CI 1.10-1.43]). Men had significantly higher rates of revision of index knee arthroplasty at 5 years (hazard ratio 1.20 [95% CI 1.05-1.36]) compared to women. CONCLUSION: The higher rates of mortality, hospital readmissions, revision surgery, and wound infections in men undergoing elective primary TKA compared to women indicate there is a sex disparity in these outcomes.

Patient race and surgical outcomes after total knee arthroplasty: an analysis of a large regional database.

OBJECTIVE: To examine racial differences in surgical complications, mortality, and revision rates after total knee arthroplasty. METHODS: We studied patients undergoing primary total knee arthroplasty using 2001-2007 Pennsylvania Health Care Cost Containment Council data. We conducted bivariate analyses to assess the risk of complications such as myocardial infarction, venous thromboembolism, wound infections, and failure of prosthesis, as well as 30-day and 1-year overall mortality after elective total knee arthroplasty, between racial groups. We estimated Kaplan-Meier 1- and 5-year surgical revision rates, and fit multivariable Cox proportional hazards models to compare surgical revision by race, incorporating 5 years of followup. We adjusted for patient age, sex, length of hospital stay, surgical risk of death, type of health insurance, hospital surgical volume, and hospital teaching status. RESULTS: In unadjusted analyses, there were no significant differences by racial group for either overall 30-day or in-hospital complication rates, or 30-day and 1-year mortality rates. Adjusted Cox models incorporating 5 years of followup showed an increased risk of revisions for African American patients (hazard ratio [HR] 1.39, 95% confidence interval [95% CI] 1.08-1.80), younger patients (HR 2.30, 95% CI 1.96-2.69), and lower risk for female patients (HR 0.81, 95% CI 0.71-0.92). CONCLUSION: In this sample of patients who underwent knee arthroplasty, we found no significant racial differences in major complication rates or mortality. However, African American patients, younger patients, and male patients all had significantly higher rates of revision based on 5 years of followup.

A retrospective study of cervical screening in women under 25 years (2005-2009).

OBJECTIVE: Since 2003, when the age threshold of cervical screening in England has been raised from 20 to 25, there have been many calls to restore the previous starting age for cervical screening as there are concerns about the delaying of initiating cervical screening may result in an increase in the risk of cervical cancer. We conducted a retrospective study to analyse the safety of changing the starting age of cervical screening programme in England to the age of 25, by reviewing the cervical cytology performed in 426 women under 25 years in Bromley Borough of London, UK, between 2005 and 2009. STUDY DESIGN: We conducted a retrospective analysis of 426 women under 25 years, who were referred with cervical smears taken at Bromley PCT's to the colposcopy clinic at Bromley Hospitals, South London Healthcare NHS Trust, over a 4-year period, between 2005 and 2009. The colposcopy findings and histology results were reviewed and analysed. RESULTS: In our review, 44.80 % of smears showed mild dyskaryosis. 23 and 12 % showed moderate dyskaryosis and severe dyskaryosis, respectively. 11.2 % had borderline smear, and 0.2 % revealed glandular changes. On colposcopic examination, only 16.2 % (69) were reported as normal; however, 25.8, 20 % of the women were diagnosed with low and high grade abnormalities, respectively. 12 % (53) of the cases showed HPV-related changes, whereas no suspected malignancy was found. Colposcopic-directed cervical biopsy was obtained in 228 women (~54 %) depending on the colposcopic examination findings. The most histological finding was CIN I which constitutes 48 % (110) of all biopsies. However, 25 % (58) and 9 % (20) revealed CIN II and CIN III, respectively. The glandular changes noticed in only one case (0.44 %). The treatment was planned for 130 women, a significant proportion (30.5 %) of the 426 women who referred for colposcopy. The histological examination of the biopsies showed CIN in 91 % of the cases (115), 74.8 % (86) of them had CIN II (36) or CIN III (50). In addition, the glandular changes found in two cases (1.6 %). More importantly, there was one case diagnosed with micro-invasive cervical cancer (0.79 %) and this comprises 0.23 % of our sample. CONCLUSION: In view of the size and the heterogeneity of our sample, it is difficult to recommend changing the starting age of the cervical screening programme. However, we strongly recommend to have a low threshold to offering cervical cytology to the women under 25 on clinical basis, particularly, after the recent introduction of HPV triage (outside the scope of this study), which will enable us to avoid the two main disadvantages of the early screening, namely over-diagnosis and over-treatment.

Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial.

BACKGROUND: Compared with white persons, African Americans have a greater incidence of diabetes, decreased control, and higher rates of microvascular complications. A peer mentorship model could be a scalable approach to improving control in this population and reducing disparities in diabetic outcomes. OBJECTIVE: To determine whether peer mentors or financial incentives are superior to usual care in helping African American veterans decrease their hemoglobin A(1c) (HbA(1c)) levels. DESIGN: A 6-month randomized, controlled trial. (ClinicalTrials.gov registration number: NCT01125956) SETTING: Philadelphia Veterans Affairs Medical Center. PATIENTS: African American veterans aged 50 to 70 years with persistently poor diabetes control. INTERVENTION: 118 patients were randomly assigned to 1 of 3 groups: usual care, a peer mentoring group, and a financial incentives group. Usual care patients were notified of their starting HbA(1c) level and recommended goals for HbA(1c). Those in the peer mentoring group were assigned a mentor who formerly had poor glycemic control but now had good control (HbA(1c) level ≤7.5%). The mentor was asked to talk with the patient at least once per week. Peer mentors were matched by race, sex, and age. Patients in the financial incentive group could earn $100 by decreasing their HbA(1c) level by 1% and $200 by decreasing it by 2% or to an HbA(1c) level of 6.5%. MEASUREMENTS: Change in HbA(1c) level at 6 months. RESULTS: Mentors and mentees talked the most in the first month (mean calls, 4; range, 0 to 30), but calls decreased to a mean of 2 calls (range, 0 to 10) by the sixth month. Levels of HbA(1c) decreased from 9.9% to 9.8% in the control group, from 9.8% to 8.7% in the peer mentor group, and from 9.5% to 9.1% in the financial incentive group. Mean change in HbA(1c) level from baseline to 6 months relative to control was -1.07% (95% CI, -1.84% to -0.31%) in the peer mentor group and -0.45% (CI, -1.23% to 0.32%) in the financial incentive group. LIMITATION: The study included only veterans and lasted only 6 months. CONCLUSION: Peer mentorship improved glucose control in a cohort of African American veterans with diabetes. PRIMARY FUNDING SOURCE: National Institute on Aging Roybal Center.

The optimal delivery of palliative care: a national comparison of the outcomes of consultation teams vs inpatient units.

BACKGROUND: Growing attention to end-of-life care has led to intensive efforts to provide better palliative care. However, it is not known whether palliative care is best provided by consultative teams or in dedicated units. METHODS: This nationwide telephone survey was conducted in 77 Veterans Affairs medical centers that offer palliative care consultation services and dedicated palliative care units. One family member per patient who died at a participating Veterans Affairs medical center between July 1, 2008, and December 31, 2009, was invited to participate. The telephone survey included 1 global rating item and 9 core items describing the patient's care in the last month of life. RESULTS: Interviews were completed with family members for 5901 of 9546 patients. Of these, 1873 received usual care, 1549 received a palliative care consultation, and 2479 received care in a palliative care unit. After nonresponse weighting and propensity score adjustment, families of patients who received a palliative care consultation were more likely than those who received usual care to report that the patient's care in the last month of life had been "excellent" (adjusted proportions: 51% vs 46%; odds ratio [OR], 1.25; 95% confidence interval [CI], 1.02-1.55; P = .04). However, families of patients who received care in a palliative care unit were even more likely to report excellent care (adjusted proportions: 63% vs 53%; OR, 1.52; 95% CI, 1.25-1.85; P < .001). CONCLUSION: Care received in palliative care units may offer more improvements in care than those achieved with palliative care consultations.

Can we make reports of end-of-life care quality more consumer-focused? results of a nationwide quality measurement program.

OBJECTIVES: The goal of this study was to define families' priorities for various aspects of end-of-life care, and to determine whether scores that reflect these priorities alter facilities' quality rankings. DESIGN: Nationwide telephone survey. SETTING: 62 VA medical centers, including acute and long term care. PARTICIPANTS: For each patient who died in a participating facility, one family member was invited to participate. MEASUREMENTS: A survey included 14 items describing key aspects of the patient's care in his or her last month of life, and one global rating. A weighted score was calculated based on the association between each item and the global rating. RESULTS: Interviews were completed with family members for 3,897 of 7,110 patients (55%). Items showed an approximately 5-fold range of weights, indicating a wide variation in the importance that families placed on aspects of palliative care (low: pain management, weight = 0.54, 95% CI 0.38-0.70;/P/<0.001; high: providers were "kind, caring, and respectful: weight = 2.46, 95% CI 2.24-2.68;/P/<0.001). Weights were homogeneous across patient subgroups, and there were no significant changes in facilities' quality rankings when weights were used. Both weighted and unweighted scores showed similar evidence of the impact of process measures. CONCLUSION: There appears to be wide variation in the importance that families place on several aspects of end-of-life care. However, the impact of weighting was generally even across patient subgroups and facilities. Therefore, the use of weights to account for families' priorities is not likely to alter a facility's quality score.