110 research outputs found

    Projecting the potential impact of the Cap-Score™ on Clinical Pregnancy, Live Births, and Medical Costs in Couples with Unexplained Infertility.

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    Purpose The Cap-Score™ was developed to assess the capacitation status of men, thereby enabling personalized management of unexplained infertility by choosing timed intrauterine insemination (IUI), versus immediate in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) in individuals with a low Cap-Score™. The objective of this study was to estimate the differences in outcomes and costs comparing the use of the Cap-Score™ with timed IUI (CS-TI) and the standard of care (SOC), which was assumed to be three IUI cycles followed by three IVF-ICSI cycles. Methods We developed and parameterized a decision-analytic model of management of unexplained infertility for women based on data from the published literature. We calculated the clinical pregnancy rates, live birth rates, and medical costs comparing CS-TI and SOC. We used Monte Carlo simulation to quantify uncertainty in projected estimates and performed univariate sensitivity analysis. Results Compared to SOC, CS-TI was projected to increase the pregnancy rate by 1–26%, marginally reduce live birth rates by 1–3% in couples with women below 40 years, increase live birth rates by 3–7% in couples with women over 40 years, reduce mean medical costs by 40004000–19,200, reduce IUI costs by 600600–1370, and reduce IVF costs by 34003400–17,800, depending on the woman’s age. Conclusion The Cap-Score™ is a potentially valuable clinical tool for management of unexplained infertility because it is projected to improve clinical pregnancy rates, save money, and, depending on the price of the test, increase access to treatment for infertility

    Effects of Ohio Opioid Prescribing Policy on Postsurgical Prescriptions Following Sports Procedures

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    Background: Prescribed opioid medication after orthopedic sports surgery has been shown to exceed patient requirements. In 2017, as a response to the opioid epidemic, Ohio passed Opioid Prescribing Guidelines (OPG) limiting narcotic prescriptions for acute pain. This study sought to evaluate the effects of the OPG on prescribing behavior of orthopedists following knee arthroscopy (KA), shoulder arthroscopy (SA), and anterior cruciate ligament reconstruction (ACLR). Methods: An institutional database was queried to calculate morphine equivalent dose (MED) prescribed at discharge, acute follow-up (\u3c90 days), and chronic follow-up (\u3e90 days) and compare MED pre- and post-OPG. Cases were identified over a 2-year period starting 1 year prior to OPG implementation. Individual surgeon data were tracked to control for inter-surgeon variability. Results: A total of 1663 patients were included in the analysis. Demographic variables were similar pre- and post-OPG for each procedure group. With all surgeons included, average discharge MED decreased significantly for all procedures from pre- to post-OPG. Surgeons qualified for individual analysis if they had at least 10 surgeries pre- and post-OPG. Of qualifying providers, 80% of KA, 25% of SA, and 0% of ACLR surgeons reduced discharge MED prescribed post-OPG. MED prescribed during follow-up was largely unaffected by implementation of the OPG. Conclusion: Average discharge morphine equivalent dose (MED) prescribed after SA, KA, and ACLR decreased following the implementation of the OPG. The MED reduction effect of the OPG was the greatest in magnitude after SA, and SA was the only surgery that showed MED reductions that persisted during acute follow up. Opioid prescriptions beyond 90 days postoperatively were unchanged by the OPG for all surgeries. Policy that restricts postoperative opioid prescriptions can be an effective, but incomplete method to address the opioid crisis

    Effects of Ohio Opioid Prescribing Policy on Postsurgical Prescriptions Following Sports Procedures

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    Background: Prescribed opioid medication after orthopedic sports surgery has been shown to exceed patient requirements. In 2017, as a response to the opioid epidemic, Ohio passed Opioid Prescribing Guidelines (OPG) limiting narcotic prescriptions for acute pain. This study sought to evaluate the effects of the OPG on prescribing behavior of orthopedists following knee arthroscopy (KA), shoulder arthroscopy (SA), and anterior cruciate ligament reconstruction (ACLR). Methods: An institutional database was queried to calculate morphine equivalent dose (MED) prescribed at discharge, acute follow-up (\u3c90 days), and chronic follow-up (\u3e90 days) and compare MED pre- and post-OPG. Cases were identified over a 2-year period starting 1 year prior to OPG implementation. Individual surgeon data were tracked to control for inter-surgeon variability. Results: A total of 1663 patients were included in the analysis. Demographic variables were similar pre- and post-OPG for each procedure group. With all surgeons included, average discharge MED decreased significantly for all procedures from pre- to post-OPG. Surgeons qualified for individual analysis if they had at least 10 surgeries pre- and post-OPG. Of qualifying providers, 80% of KA, 25% of SA, and 0% of ACLR surgeons reduced discharge MED prescribed post-OPG. MED prescribed during follow-up was largely unaffected by implementation of the OPG. Conclusion: Average discharge morphine equivalent dose (MED) prescribed after SA, KA, and ACLR decreased following the implementation of the OPG. The MED reduction effect of the OPG was the greatest in magnitude after SA, and SA was the only surgery that showed MED reductions that persisted during acute follow up. Opioid prescriptions beyond 90 days postoperatively were unchanged by the OPG for all surgeries. Policy that restricts postoperative opioid prescriptions can be an effective, but incomplete method to address the opioid crisis

    Primary Hemiarthroplasty for the Treatment of Basicervical Femoral Neck Fractures

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    Purpose Basicervical femoral neck fractures are uncommon injuries that occur at the extracapsular base of the femoral neck at its transition with the intertrochanteric line. Controversy remains in the orthopedic literature as to the optimal method of treatment for this fracture type given the inherent instability and greater rate of implant failure with traditional fixation constructs. The purpose of this study is to quantify the incidence and preferred treatment methods of basicervical hip fractures at a single, regional, Level 1 trauma center and to identify differences in postoperative complications between treatment options. Methods The present study is a retrospective case series from a single regional health network, including 316 patients with hip fractures. Basicervical femoral neck fractures were identified. Reoperation rates within 90 days, implant failures or nonunions, postoperative ambulation distances and range of motion, and discharge dispositions were compared across patients grouped by surgical treatment with either cephalomedullary nail, sliding hip screw, or hemiarthroplasty (HA). Results Basicervical femoral neck fractures represented 6.6% of this study population. The cephalomedullary nail group demonstrated rates of implant failure and return to the operating room within 90 days of 40% (4/10) and 20% (2/10), respectively. No patients who underwent hemiarthroplasty experienced a failure of fixation or return to the operating room. Conclusions This study suggests a much lower rate of fixation failure or need for reoperation with hemiarthroplasty treatment compared to cephalomedullary nail construct for basicervical femoral neck fractures and may be an underutilized treatment method for this fracture type. The promising results seen with this case series should encourage further investigation into HA as a primary treatment for these uncommon, yet challenging, fractures

    Clinical outcomes of escalation vs early intensive disease-modifying therapy in patients with multiple sclerosis

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    IMPORTANCE Uncertainty remains about how aggressively to treat early multiple sclerosis. High-efficacy disease-modifying therapies (DMTs) are often reserved for individuals expressing poor prognostic features at baseline. OBJECTIVE To analyze long-term outcomes in a population-based cohort according to initial treatment strategy. DESIGN, SETTING AND PARTICIPANTS In this cohort study, data were derived from January 1998 to December 2016, and analysis was performed in January 2017. From a total of 720 patients prescribed a DMT, 592 (82%) were included in analysis. Reasons for exclusion were first treated elsewhere or privately (n = 39), clinical trial participant (n = 25), and insufficient clinical data (n = 45). EXPOSURES Patients were classified according to first-line treatment strategy: high-efficacy (early intensive treatment [EIT]) or moderate-efficacy DMT (escalation [ESC]). MAIN OUTCOMES AND MEASURES Primary outcome was 5-year change in Expanded Disability Status Scale score. Secondary outcome was time to sustained accumulation of disability (SAD). Models were adjusted for sex, age at treatment, year of starting DMT, and escalation to high-efficacy treatment in the ESC group. RESULTS Mean (SD) age of 592 patients at symptom onset was 27.0 (9.4) years. Mean (SD) 5-year change in Expanded Disability Status Scale score was lower in the EIT group than the ESC group (0.3 [1.5] vs 1.2 [1.5]); this remained significant after adjustment for relevant covariates (β = −0.85; 95% CI, −1.38 to −0.32; P = .002). Median (95% CI) time to SAD was 6.0 (3.17-9.16) years for EIT and 3.14 (2.77-4.00) years for ESC (P = .05). For those within the ESC group who escalated to high-efficacy DMT as second-line treatment, median (95% CI) time to SAD was 3.3 years (1.8-5.6; compared with EIT group log-rank test P = .08). After adjustment for relevant covariates, there was no difference in hazard of SAD between the groups. However, 60% of those who escalated to high-efficacy DMTs were observed to develop SAD while still receiving initial moderate-efficacy treatment before escalation. CONCLUSIONS AND RELEVANCE In a real-life setting, long-term outcomes were more favorable following early intensive therapy vs first-line moderate-efficacy DMT. Contemporary surveillance strategies and escalation protocols may be insufficiently responsive. This finding is particularly relevant as patients in real-world practice are typically selected for an EIT approach to therapy on the basis of clinical and radiological features predictive of a poor outcome. These data support the need for a prospective randomized clinical trial

    How common is truly benign MS in a UK population?

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    Objectives The prevalence and definition of benign multiple sclerosis (BMS) remain controversial. Most definitions are based on the Expanded Disability Status Scale (EDSS), not encompassing the wider impact of disease. The explanation for favourable outcomes remains unclear. We aim to provide a detailed characterisation of patients with low EDSS scores at long disease durations. Methods We screened a population-based registry containing 3062 people with MS to identify individuals with unlimited walking ability at disease durations >15 years. A representative cohort underwent detailed clinical assessment and classified as having BMS according to EDSS score <3, no significant fatigue, mood disturbance, cognitive impairment or disrupted employment, and had not received a disease-modifying therapy. We determined patient-reported perceptions of MS status and made comparisons with EDSS-based definitions. Results Of 1049 patients with disease duration of >15 years, 200 (19.1%) had most recent EDSS score <4.0. Detailed contemporary clinical assessment of a representative sample of 60 of these patients revealed 48 (80%) had an EDSS score of <4.0, 35 (58%) <3.0 and 16 (27%) <2.0. Only nine (15%) fulfilled our criteria for BMS; impaired cognition (57%) and effects on employment (52%) the most common causes for exclusion. Meanwhile, 33/60 (69%) patients considered their disease benign. Population frequency for BMS was estimated at 2.9% (95% CI 2.0 to 4.1). Conclusions Comprehensive assessment reveals a small minority of people with MS who appear genuinely benign after 15 years. Study of such individuals may uncover insights about disease pathogenesis. However, discrepancy between patient perception and clinician perception of BMS undermines use of the term ‘benign’ in clinical settings

    A contemporary study of mortality in the multiple sclerosis population of south east Wales

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    Background Mortality studies in multiple sclerosis (MS) are valuable to identify changing disease patterns and inform clinical management. This study examines mortality in a British MS cohort. Methods Patients were selected from the southeast Wales MS registry. Hazard of death was analysed using Cox proportional hazards regression, adjusted for onset age, annualised relapse rate, initial disease course, time to EDSS 4.0, sex, socioeconomic status, and onset year. Age- and sex-stratified standardised mortality ratios (SMRs) were calculated by EDSS scores. Results Median time from MS diagnosis to death was 35.5 years and median age 73.9. Older onset age (hazard ratio [HR] 1.05, 95% confidence interval 1.03–1.06) was associated with increased hazard of death. Primary progressive course was associated with increased hazard of death in women (HR 2.04, 1.15–3.63) but not men (HR 1.23, 0.61–2.47). Slow time to EDSS 4.0 (HR 0.41, 0.28–0.60) and high socioeconomic status (HR 0.54, 0.37–0.79) were associated with reduced hazard of death. SMR increased from EDSS 6.0 (3.86, 2.63–5.47) but more substantially at EDSS 8.0 (22.17, 18.20–26.75). Conclusions Risk of death in MS varies substantially with degree of disability. This has important implications for clinical management and health economic modelling

    Sarcoidosis following alemtuzumab treatment for multiple sclerosis

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    Despite proven efficacy of alemtuzumab in multiple sclerosis (MS), approximately 50% of individuals will develop a new autoimmune disease following treatment. To date, these have largely been antibody mediated and organ specific (primarily affecting the thyroid gland). In a retrospective case series of 187 patients from two UK specialist centres (Cardiff and Cambridge) followed up for a median of 10 years, we report three (1.6%) cases of sarcoidosis following alemtuzumab treatment of MS. This report increases the spectrum of auto-inflammatory disease following alemtuzumab and should be considered by clinicians when using this therapeutic agent for MS
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