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Management of coronary artery disease (CAD) has evolved over the past decade, but there are few prospective studies evaluating long-term outcomes in a real-world setting of evolving technical approaches and secondary prevention. The aim of this study was to determine how the mortality and morbidity of CAD has changed in patients who have undergone percutaneous coronary intervention (PCI), in the setting of co-morbidities and evolving management. The National Heart, Lung, and Blood Institute Dynamic Registry was a cohort study of patients undergoing PCI at various time points. Cohorts were enrolled in 1999 (cohort 2, n = 2,105), 2004 (cohort 4, n = 2,112), and 2006 (cohort 5, n = 2,176), and each was followed out to 5 years. Primary outcomes were death, myocardial infarction (MI), coronary artery bypass grafting, repeat PCI, and repeat revascularization. Secondary outcomes were PCI for new obstructive lesions at 5 years, 5-year rates of death and MI stratified by the severity of coronary artery and co-morbid disease. Over time, patients were more likely to have multiple co-morbidities and more severe CAD. Despite greater disease severity, there was no significant difference in death (16.5% vs 17.6%, adjusted hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.74 to 1.08), MI (11.0% vs 10.6%, adjusted HR 0.87, 95% CI 0.70 to 1.08), or repeat PCI (20.4% vs 22.2%, adjusted HR 0.98, 95% CI 0.85 to 1.17) at 5-year follow-up, but there was a significant decrease in coronary artery bypass grafting (9.1% vs 4.3%, adjusted HR 0.44, 95% CI 0.32 to 0.59). Patients with 5 co-morbidities had a 40% to 60% death rate at 5 years. There was a modestly high rate of repeat PCI for new lesions, indicating a potential failure of secondary prevention for this population in the face of increasing co-morbidity. Overall 5-year rates of death, MI, repeat PCI, and repeat PCI for new lesions did not change significantly in the context of increased co-morbidities and complex disease.

Background We aimed to conduct a qualitative prospective preference assessment (PPA) to assess participants’ willingness to enroll in a planned randomized controlled trial (RCT). The planned RCT would enroll participants with meniscal tear with persistent knee pain following a course of physical therapy (PT) and would compare outcomes of arthroscopic partial meniscectomy (APM) vs. enhanced conservative care. Methods We identified participants 45–85 years old with suspected meniscal tear who were referred to PT. After 10 weeks of PT, participants were sent a questionnaire that assessed knee pain. We asked participants reporting persistent knee pain to participate in a follow-up interview. We conducted semi-structured interviews and coded and analyzed transcripts to identify themes related to enrollment in our planned RCT. Results We analyzed transcripts from twenty participants (mean age (SD): 61.6 (6.16); 60% male, 100% White). 70% said they would participate in the trial. Willingness to enroll was associated with participants’ preferences for treatment modality and most were willing to continue PT, despite reporting persistent pain. Of those unwilling to enroll, all were averse to surgery or did not believe they needed surgery. Others had concerns about oral medications and injections, but these were not “dealbreakers” for willingness to enroll. Provider trust was a dominant decision-making factor in respondents’ willingness to enroll. Conclusion These findings suggest that investigators should consider additional education for participants regarding the benefits and risks of all treatment options at the time of enrollment invitation. Additionally, the trial should be introduced by a trusted provider.

In patients in a large registry who received coronary stents for off-label indications, there was no difference in mortality or rates of myocardial infarction at 1 year between those receiving bare-metal stents and those receiving drug-eluting stents. In the group receiving drug-eluting stents, there was a reduced need for revascularization. There was no difference in mortality or rates of myocardial infarction at 1 year between those receiving bare-metal stents and those receiving drug-eluting stents. In the group receiving drug-eluting stents, there was a reduced need for revascularization. In 2003, the Food and Drug Administration (FDA) approved drug-eluting stents for the treatment of coronary artery disease. This decision was based on the results of clinical trials that compared a bare-metal stent with a drug-eluting stent in highly selected patients. 1 – 10 Because of the magnitude of the treatment effect of drug-eluting stents in suppressing the recurrence of lesions, consistent positive reports from subsequent trials of small subgroups, and firsthand experiences, physicians extended the use of drug-eluting stents to patients with clinical and anatomical features beyond those of patients in the FDA-approval trials. The use of drug-eluting stents in this . . .

The Ponseti Method has dramatically altered the management of clubfoot, with particular implications for limited-resource settings. We sought to describe outcomes of care and risk factors for sub-optimal results using the Ponseti Method in Haiti. We conducted a records review of patients presenting from 2011-2015 to a CURE Clubfoot clinic in Port-au-Prince, Haiti. We report patient characteristics (demographics and clinical), treatment patterns (cast number/duration and tenotomy rates), and outcomes (relapse and complications). We compared treatment with benchmarks in high-income nations and used generalized linear models to identify risk factors for delayed presentation, increased number of casts, and relapse. Amongst 168 children, age at presentation ranged from 0 days (birth) to 4.4 years, 62% were male, 35% were born at home, 63% had bilateral disease, and 46% had idiopathic clubfeet. Prior treatment (RR 6.33, 95% CI 3.18-12.62) was associated with a higher risk of delayed presentation. Risk factors for requiring ≥ 10 casts included having a non-idiopathic diagnosis (RR 2.28, 95% CI 1.08-4.83) and higher Pirani score (RR 2.78 per 0.5 increase, 95% CI 1.17-6.64). Female sex (RR 1.54, 95% CI 1.01-2.34) and higher Pirani score (RR 1.09 per 0.5 increase, 95% CI 1.00-1.17) were risk factors for relapse. Compared to North American benchmarks, children presented later (median 4.1 wks [IQR 1.6-18.1] vs. 1 wk), with longer casting (12.5 wks [SD 9.8] vs. 7.1 wks), and higher relapse (43% vs. 22%). Higher Pirani score, prior treatment, non-idiopathic diagnosis, and female sex were associated with a higher risk of sub-optimal outcomes in this low-resource setting. Compared to high-income nations, serial casting began later, with longer duration and higher relapse. Identifying patients at risk for poor outcomes in a low-resource setting can guide counseling, program development, and resource allocation.

Insulin Therapy and Glycemic Control in Hospitalized Patients With Diabetes During Enteral Nutrition Therapy A randomized controlled clinical trial Mary T. Korytkowski , MD , 1 , Rose J. Salata , MD 1 , Glory L. Koerbel , RN, MSN 1 , Faith Selzer , PHD 2 , Esra Karslioglu , MD 1 , Almoatazbellah M. Idriss , MD 1 , Kenneth K.W. Lee , MD 3 , A. James Moser , MD 3 and Frederico G.S. Toledo , MD 1 1 Division of Endocrinology, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania; 2 Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania; 3 Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Corresponding author: Mary T. Korytkowski, korytkowski{at}dom.pitt.edu . Abstract OBJECTIVE To compare two subcutaneous insulin strategies for glycemic management of hyperglycemia in non–critically ill hospitalized patients with diabetes during enteral nutrition therapy (ENT). RESEARCH DESIGN AND METHODS Fifty inpatients were prospectively randomized to receive sliding-scale regular insulin (SSRI) alone ( n = 25) or in combination with insulin glargine ( n = 25). NPH insulin was added for persistent hyperglycemia in the SSRI group (glucose >10 mmol/l). RESULTS Glycemic control was similar in the SSRI and glargine groups (mean ± SD study glucose 8.9 ± 1.6 vs. 9.2 ± 1.6 mmol/l, respectively; P = 0.71). NPH insulin was added in 48% of the SSRI group subjects. There were no group differences in frequency of hypoglycemia (1.3 ± 4.1 vs. 1.1 ± 1.8%; P = 0.35), total adverse events, or length of stay. CONCLUSIONS Both insulin strategies (SSRI with the addition of NPH for persistent hyperglycemia and glargine) demonstrated similar efficacy and safety in non–critically ill hospitalized patients with type 2 diabetes during ENT. Footnotes The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. Received August 4, 2008. Accepted November 26, 2008. © 2009 by the American Diabetes Association.

Background Knee osteoarthritis (OA) is prevalent and often associated with meniscal tear. Physical therapy (PT) and exercise regimens are often used to treat OA or meniscal tear, but, to date, few programs have been designed specifically for conservative treatment of meniscal tear with concomitant knee OA. Clinical care and research would be enhanced by a standardized, evidence–based, conservative treatment program and the ability to study the effects of the contextual factors associated with interventions for patients with painful, degenerative meniscal tears in the setting of OA. This paper describes the process of developing both a PT intervention and a home exercise program for a randomized controlled clinical trial that will compare the effectiveness of these interventions for patients with knee pain, meniscal tear and concomitant OA. Methods This paper describes the process utilized by an interdisciplinary team of physical therapists, physicians, and researchers to develop and refine a standardized in-clinic PT intervention, and a standardized home exercise program to be carried out without PT supervision. The process was guided in part by Medical Research Council guidance on intervention development. Results The investigators achieved agreement on an in-clinic PT intervention that included manual therapy, stretching, strengthening, and neuromuscular functional training addressing major impairments in range of motion, musculotendinous length, muscle strength and neuromotor control in the major muscle groups associated with improving knee function. The investigators additionally achieved agreement on a progressive, protocol-based home exercise program (HEP) that addressed the same major muscle groups. The HEP was designed to allow patients to perform and progress the exercises without PT supervision, utilizing minimal equipment and a variety of methods for instruction. Discussion This multi-faceted in-clinic PT program and standardized HEP provide templates for in-clinic and home-based care for patients with symptomatic degenerative meniscal tear and concomitant OA. These interventions will be tested as part of the Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial. Trial registration The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 on February 14, 2017. TeMPO was also approved by the Institutional Review Board at Partners HealthCare/Brigham and Women’s Hospital.

Background: Understanding the factors contributing to willingness to participate in randomized clinical trials (RCTs) after anterior cruciate ligament reconstruction (ACLR) is crucial to optimizing recruitment and understanding whether interested participants represent the patient population that may benefit from the studied treatment. Purpose: To understand patients’ willingness to participate in a future RCT of an oral medication to prevent posttraumatic osteoarthritis (PTOA) after ACLR. Study Design: Cross-sectional study; Level of evidence, 3. Methods: A total of 103 patients aged 18 to 45 years who were either planning to undergo ACLR in the next 4 months or had undergone ACLR within 1 year of the screening date were recruited from 2 institutions. The patients viewed a video explaining the trial and completed a questionnaire that included demographic characteristics, pain intensity, activity level, willingness to participate in the hypothetical trial, and their perceived risk (on a scale of 0%-100%) of developing knee PTOA (next 10 years or lifetime). Results: Within the cohort, 31% stated they were “definitely willing,” 38% were “probably willing,” 17% were “unsure,” and 14% were “unwilling” to participate in a hypothetical trial. Willingness did not differ by pain or activity level; however, younger patients stated they were less willing to participate. The most common reasons for unwillingness to participate included not wanting to take a medication daily (59%) and concerns about medication risks or side effects (59%). Respondents who indicated a definite willingness to participate in the trial had higher perceptions of their own PTOA risk over the next 10 years than those who indicated they would not participate (70% vs 50%). Conclusion: In this prospective preference assessment, 69% of survey respondents expressed a willingness to participate in an RCT involving an oral medication to potentially alter the progression of PTOA after ACLR. The results suggest that an RCT in this study should include clear and concise information on the risk of developing PTOA after ACLR and the safety and tolerability of study medications in the recruitment materials.

Background Meniscal tears often accompany knee osteoarthritis, a disabling condition affecting 14 million individuals in the United States. While several randomized controlled trials have compared physical therapy to surgery for individuals with knee pain, meniscal tear, and osteoarthritic changes (determined via radiographs or magnetic resonance imaging), no trial has evaluated the efficacy of physical therapy alone in these subjects. Methods The Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial is a four-arm multi-center randomized controlled clinical trial designed to establish the comparative efficacy of two in-clinic physical therapy interventions (one focused on strengthening and one containing placebo) and two protocolized home exercise programs. Discussion The goal of this paper is to present the rationale behind TeMPO and describe the study design and implementation strategies, focusing on methodologic and clinical challenges. Trial registration The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 . on February 14, 2017.

The optimal duration of dual-antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important, unanswered question. This study was designed to evaluate the association of varying durations of DAPT on clinical outcomes after DES implantation for the treatment of coronary artery disease. Using the National Heart, Lung, and Blood Institute Dynamic Registry, patients enrolled in the last 2 waves after index percutaneous coronary intervention with DES and who were event free at the time of landmark analysis were included. Landmark analysis was performed 12 and 24 months after percutaneous coronary intervention, and patients were stratified according to continued use of DAPT or not. Subjects were evaluated for rates of death, myocardial infarction, and stent thrombosis at 4 years from their index procedures. The numbers of evaluable patients were 2,157 and 1,918 for the 12- and 24-month landmarks, respectively. In both landmark analyses, there was a significantly lower 4-year rate of death or myocardial infarction in the group that continued DAPT compared to the group that did not (12 months: 10.5% vs 14.5%, p = 0.01; 24 months: 5.7% vs 8.6%, p = 0.02). Beneficial differences in the group that continued on DAPT were preserved after multivariate and propensity adjustment. There were no significant differences in definite stent thrombosis in either landmark analysis. In conclusion, at 12 and 24 months after DES implantation, continued use of DAPT was associated with lower 4-year risk for death and myocardial infarction.

Objective To examine impact of pre‐existing and incident problematic musculoskeletal (MSK) areas after total knee replacement (TKR) on postoperative 60‐month Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain/function scores. Methods Using data from a randomized controlled trial of subjects undergoing TKR for osteoarthritis, we assessed problematic MSK areas in six body regions before TKR and 12, 24, 36, and 48 months after TKR. We defined the following two variables: 1) density count (number of problematic MSK areas occurring after TKR; range 0‐24) and 2) cumulative density count (problematic MSK areas both before and after TKR, categorized into four levels: no preoperative areas and density count of 0‐1 [reference group]; no preoperative areas and density count of 2 or more; one or more preoperative areas and density count of 0‐1; and one or more preoperative areas and density count of 2 or greater). We evaluated the associations between categorized 60‐month WOMAC and cumulative density count by ordinal logistic regression. Results Among 230 subjects, 24% reported one or more preoperative problematic MSK area. After TKR, 75% reported a density count of 0 to 1; 25% reported a density count of 2 or more. Compared with the reference group, each cumulative density count category was associated with an increased odds of having a higher category of 60‐month WOMAC pain score, as follows: 2.97 (95% confidence interval [CI], 1.48‐5.98) for no preoperative problematic areas and density count of 2 or greater, 3.31 (95% CI, 1.64‐6.66) for one or more preoperative problematic areas and density count of 0 to 1, and 2.85 (95% CI, 0.97‐8.39) for one or more preoperative problematic areas and density count of 2 or greater. Similar associations were observed with 60‐month WOMAC function score. Conclusion In TKR recipients, the presence of problematic musculoskeletal areas beyond the index knee—preoperatively and/or postoperatively—was associated with worse 60‐month WOMAC pain/function score.