Early Stage Blood Purification for Paraquat Poisoning: A Multicenter Retrospective Study.

PubMed

Li, An; Li, Wenxiong; Hao, Fengtong; Wang, Haishi

2016-01-01

To evaluate the efficacy of conservative treatment vs. hemoperfusion (HP) vs. HP + continuous veno-venous hemofiltration (CVVH) for acute Paraquat (PQ) poisoning. This was a multicenter retrospective study of patients with PQ poisoning between January 2013 and June 2014. Clinical data and PQ serum levels were collected at baseline and after 24, 48, and 72 h of treatment. Seventy-five, 65, and 43 underwent conservative treatment only (conservative treatment group), conservative treatment + HP (HP group), and conservative treatment + HP + CVVH (HP + CVVH group), respectively. PQ serum levels decreased in all groups after 72 h of treatment (p < 0.001); meanwhile, these values decreased faster in the HP and HP + CVVH groups compared with the conservative treatment group. More importantly, PQ blood levels were significantly lower in the HP + CVVH group compared with the HP group at 24 h (p < 0.05). Sequential organ failure assessment (ΔSOFA) values in the HP and HP + CVVH groups were significantly lower compared with that obtained for the conservative treatment group (p < 0.05). The 60-day survival rates were 21.3, 43.1 and 46.5%, respectively. Multivariate analysis indicated that age, PQ dose, admission PQ levels, and admission SOFA score were independently associated with mortality. HP and HP + CVVH were protective factors. Early HP or HP + CVVH after PQ poisoning could decrease PQ blood levels, alleviate organ damage, and increase survival. © 2016 S. Karger AG, Basel.

IgM myeloma: A multicenter retrospective study of 134 patients.

PubMed

Castillo, Jorge J; Jurczyszyn, Artur; Brozova, Lucie; Crusoe, Edvan; Czepiel, Jacek; Davila, Julio; Dispenzieri, Angela; Eveillard, Marion; Fiala, Mark A; Ghobrial, Irene M; Gozzetti, Alessandro; Gustine, Joshua N; Hajek, Roman; Hungria, Vania; Jarkovsky, Jiri; Jayabalan, David; Laubach, Jacob P; Lewicka, Barbara; Maisnar, Vladimir; Manasanch, Elisabet E; Moreau, Philippe; Morgan, Elizabeth A; Nahi, Hareth; Niesvizky, Ruben; Paba-Prada, Claudia; Pika, Tomas; Pour, Ludek; Reagan, John L; Richardson, Paul G; Shah, Jatin; Spicka, Ivan; Vij, Ravi; Waszczuk-Gajda, Anna; Gertz, Morie A

2017-08-01

IgM myeloma is a rare hematologic malignancy for which the clinicopathological features and patient outcomes have not been extensively studied. We carried out a multicenter retrospective study in patients with diagnosis of IgM myeloma defined by >10% marrow involvement by monoclonal plasma cells, presence of an IgM monoclonal paraproteinemia of any size, and anemia, renal dysfunction, hypercalcemia, lytic lesions and/or t(11;14) identified by FISH. A total of 134 patients from 20 centers were included in this analysis. The median age at diagnosis was 65.5 years with a male predominance (68%). Anemia, renal dysfunction, elevated calcium and skeletal lytic lesions were found in 37, 43, 19, and 70%, respectively. The median serum IgM level was 2,895 mg dL -1 with 19% of patients presenting with levels >6,000 mg dL -1 . International Staging System (ISS) stages 1, 2, and 3 were seen in 40 (33%), 54 (44%), and 29 (24%) of patients, respectively. The malignant cells expressed CD20 (58%) and cyclin D1 (67%), and t(11;14) was the most common cytogenetic finding (39%). The median overall survival (OS) was 61 months. Higher ISS score was associated with worse survival (P = 0.02). Patients with IgM myeloma present with similar characteristics and outcomes as patients with more common myeloma subtypes. © 2017 Wiley Periodicals, Inc.

Efficacy and tolerability of lacosamide for secondary epileptic seizures in patients with brain tumor: A multicenter, observational retrospective study

PubMed Central

Sepúlveda-Sánchez, Juan Manuel; Conde-Moreno, Antonio; Barón, Manuel; Pardo, Javier; Reynés, Gaspar; Belenguer, Antonio

2017-01-01

The present observational, multicenter, retrospective study investigated the efficacy and tolerability of lacosamide in controlling secondary epileptic seizures in patients with brain tumors in Spain. Data from the medical records of patients ≥18 years of age with brain tumors, who had received at least one dose of lacosamide for seizure management between July 2013 and November 2013, were collected. The primary and secondary objectives of the present study were to assess the effectiveness and tolerability of lacosamide. Data from 39 patients (mean age, 54.1 years; 66.7% male) were collected, where the two main reasons for initiation of lacosamide treatment were the lack of efficacy of other antiepileptic drugs (in 76.9% of patients) and the presence of adverse events (12.8%) associated with other antiepileptic drugs. At the initiation of treatment, patients received a mean lacosamide dose of 138.5±68.3 mg/day. At 6 months, lacosamide had significantly reduced the mean number of seizures from 26.4 (standard deviation [SD], 50.4) seizures for the 6 months prior to lacosamide initiation to a mean of 9.4 (SD, 22.8) seizures during the 6 months subsequent to lacosamide initiation; P<0.001. Lacosamide was generally well tolerated; of the 25 patients who had complete safety data available at a 6-month follow-up, 3 patients (12%) reported an adverse event, including dizziness, asthenia, instability and irritability. The present retrospective analysis suggested that lacosamide is an effective and well-tolerated treatment in patients experiencing seizures due to brain tumors. Additional prospective studies with a larger patient population and randomized trial design are warranted. PMID:28599411

Efficacy and tolerability of lacosamide for secondary epileptic seizures in patients with brain tumor: A multicenter, observational retrospective study.

PubMed

Sepúlveda-Sánchez, Juan Manuel; Conde-Moreno, Antonio; Barón, Manuel; Pardo, Javier; Reynés, Gaspar; Belenguer, Antonio

2017-06-01

The present observational, multicenter, retrospective study investigated the efficacy and tolerability of lacosamide in controlling secondary epileptic seizures in patients with brain tumors in Spain. Data from the medical records of patients ≥18 years of age with brain tumors, who had received at least one dose of lacosamide for seizure management between July 2013 and November 2013, were collected. The primary and secondary objectives of the present study were to assess the effectiveness and tolerability of lacosamide. Data from 39 patients (mean age, 54.1 years; 66.7% male) were collected, where the two main reasons for initiation of lacosamide treatment were the lack of efficacy of other antiepileptic drugs (in 76.9% of patients) and the presence of adverse events (12.8%) associated with other antiepileptic drugs. At the initiation of treatment, patients received a mean lacosamide dose of 138.5±68.3 mg/day. At 6 months, lacosamide had significantly reduced the mean number of seizures from 26.4 (standard deviation [SD], 50.4) seizures for the 6 months prior to lacosamide initiation to a mean of 9.4 (SD, 22.8) seizures during the 6 months subsequent to lacosamide initiation; P<0.001. Lacosamide was generally well tolerated; of the 25 patients who had complete safety data available at a 6-month follow-up, 3 patients (12%) reported an adverse event, including dizziness, asthenia, instability and irritability. The present retrospective analysis suggested that lacosamide is an effective and well-tolerated treatment in patients experiencing seizures due to brain tumors. Additional prospective studies with a larger patient population and randomized trial design are warranted.

Changing requirements and resulting needs for IT-infrastructure for longitudinal research in the neurosciences.

PubMed

Buckow, Karoline; Quade, Matthias; Rienhoff, Otto; Nussbeck, Sara Y

2016-01-01

The observation of growing "difficulties" in IT-infrastructures in neuroscience research during the last years led to a search for reasons and an analysis on how this phenomenon is reflected in the scientific literature. With a retrospective analysis of nine examples of multicenter research projects in the neurosciences and a literature review the observation was systematically analyzed. Results show that the rise in complexity mainly stems from two reasons: (1) more and more need for information on quality and context of research data (metadata) and (2) long-term requirements to handle the consent and identity/pseudonyms of study participants and biomaterials in relation to legal requirements. The combination of these two aspects together with very long study times and data evaluation periods are components of the subjectively perceived "difficulties". A direct consequence of this result is that big multicenter trials are becoming part of integrated research data environments and are not standing alone for themselves anymore. This drives up the resource needs regarding the IT-infrastructure in neuroscience research. In contrast to these findings, literature on this development is scarce and the problem probably underestimated. Copyright © 2014 Elsevier Ireland Ltd and the Japan Neuroscience Society. All rights reserved.

Multicenter Analysis of Long-Term Oncologic Impact of Anastomotic Leakage After Laparoscopic Total Mesorectal Excision

PubMed Central

Kang, Jeonghyun; Choi, Gyu-Seog; Oh, Jae Hwan; Kim, Nam Kyu; Park, Jun Seok; Kim, Min Jung; Lee, Kang Young; Baik, Seung Hyuk

2015-01-01

Abstract This study aims to validate the oncologic outcomes of anastomotic leakage (AL) after laparoscopic total mesorectal excision (TME) in a large multicenter cohort. The impact of AL after laparoscopic TME for rectal cancer surgery has not yet been clearly described. This was a multicenter retrospective study of 1083 patients who underwent laparoscopic TME for nonmetastatic rectal cancer (stage 0–III). AL was defined as an anastomotic complication within 30 days of surgery irrespective of requiring a reoperation or interventional radiology. Estimated local recurrence (LR), disease-free survival (DFS), and overall survival (OS) were compared between the leakage group and the no leakage group using the log-rank method. Multivariate Cox-regression analysis was used to adjust confounding for survival. The incidence of AL was 6.4%. Mortality within 30 days of surgery occurred in 1 patient (1.4%) in the leakage group and 2 patients (0.2%) in the no leakage group. The leakage group showed a higher LR rate (6.4% vs 1.8%, P = 0.011). Five-year DFS and OS were significantly lower in the leakage group than the no leakage group (DFS 71.7% vs 82.1%, P = 0.016, OS 81.8% vs 93.5%, P = 0.007). Multivariate analysis showed that AL was an independent poor prognostic factor for DFS and OS (hazard ratio [HR] = 1.6; 95% confidence intervals [CI]: 1.0–2.6; P = 0.042, HR = 2.1; 95% CI: 1.0–4.2; P = 0.028, respectively). AL after laparoscopic TME was significantly associated with an increased rate of LR, systemic recurrence and poor OS. PMID:26200636

Cervical spine injury: a ten-year multicenter analysis of evolution of care and risk factors for poor outcome in southeast Nigeria.

PubMed

Uche, E O; Nwankwo, O E; Okorie, E; Nnezianya, I

2015-01-01

Retrospective study. To describe the evolution of care and risk factors for poor outcome in patients with cervical spine injury (CSI) treated at three centers in southeast Nigeria. Nigeria, southeast. A 10-year retrospective multicenter analysis of patients with CSI, managed at three centers in southeast Nigeria, from January 2003 to December 2012. Two hundred and seven patients (55%) had CSI out of 377 spinal injury cases in the three study centers, but 195 cases had complete records and were studied. There were 148 males and 47 females. The age range was 3-74 years with a mean of 32.6 (± 1.9) years 95% CI. Most injuries (149 cases) resulted from motor vehicular accidents (MVA). The C5 spinal level was involved in 75 (38%) cases One hundred and seventeen patients (60%) presented with American Spinal Injury Association A (ASIA A) injury. CSI care evolved from the application of a Minerva jacket or cervical traction only to cervical traction and spinal fusion resulting in a reduction in hospital stay (F = 52.5, DF (2, 3) P < 0.05). When compared to 51 patients with incomplete injuries, who improved in neurologic al status at discharge, only three patients with ASIA grade A experienced some improvement. The mortality rate from our series is 16% (32 patients). Those who died were more likely to have a complete injury (25 patients) or a high cervical injury (X² = 61.2, P < 0.05) among other factors. The cervical spine is the most commonly injured spinal segment in southeast Nigeria. Although treatment evolution has resulted in reduction of hospital stay, the associated mortality risk still remains high.

Anorectal gastrointestinal stromal tumors: a retrospective multicenter analysis of 15 cases emphasizing their high local recurrence rate and the need for standardized therapeutic approach.

PubMed

Agaimy, Abbas; Vassos, Nikolaos; Märkl, Bruno; Meidenbauer, Norbert; Köhler, Jens; Spatz, Johann; Hohenberger, Werner; Haller, Florian; Croner, Roland S; Schneider-Stock, Regine; Matzel, Klaus

2013-08-01

This study aims to report our multicenter experience with diagnosis, management, and prognosis of anorectal gastrointestinal stromal tumors (GIST). We retrospectively reviewed cases treated and/or followed up at our institutions in the period 2000-2011. Fifteen patients were identified (eight men and seven women; mean age, 55 years). Presenting symptoms were rectal/perirectal (eight), rectovaginal space (four), or retrovesical/prostatic (three) mass. Primary surgical treatment was local excision (six), deep anterior resection (eight), and palliative diagnostic excision (one). Tumor mean size was 4.8 cm. All but two cases were high risk (Miettinen and Lasota, Semin Diagn Pathol 23:70-83, 2006). R0 resection was achieved in 46% of cases: one of six local excisions vs. five of seven deep anterior resection (16 vs. 71%, respectively). All three cases who received total mesorectal excision had R0. Non-R0 status was mainly due to opening of tumor capsule at surgery (Rx). Seven of 14 patients (50%) developed ≥1 pelvic local recurrences at a mean period of 48.4 months (mean follow-up, 61.6 months). Only two patients developed distant metastasis (adrenal, liver, and peritoneal). Recurrences developed after Rx (three), R1 (two), and unknown R-status (two). Successful mutational analysis in 13 patients revealed KIT mutations in all (10 exon 11, 2 exon 9, and 1 exon 13). Our results confirm the high local recurrence rate of anorectal GISTs (50%) which correlates with the common practice of suboptimal oncological primary tumor resection (Rx or R1 = 7/13). This uncommon subset of GISTs needs more standardized oncological surgical approach to minimize the propensity for local disease recurrence.

Multicenter retrospective study of cetuximab plus platinum-based chemotherapy for recurrent or metastatic oral squamous cell carcinoma.

PubMed

Yanamoto, Souichi; Umeda, Masahiro; Kioi, Mitomu; Kirita, Tadaaki; Yamashita, Tetsuro; Hiratsuka, Hiroyoshi; Yokoo, Satoshi; Tanzawa, Hideki; Uzawa, Narikazu; Shibahara, Takahiko; Ota, Yoshihide; Kurita, Hiroshi; Okura, Masaya; Hamakawa, Hiroyuki; Kusukawa, Jingo; Tohnai, Iwai

2018-03-01

The purpose of this study was to assess the efficacy and safety of cetuximab plus platinum-based chemotherapy for patients specifically diagnosed with recurrent or metastatic oral squamous cell carcinoma (OSCC). We conducted a multicenter retrospective observational study of patients who underwent first-line cetuximab plus platinum-based chemotherapy between December 2012 and June 2015. 65 patients received weekly cetuximab (week 1, 400 mg/m 2 ; subsequent weeks, 250 mg/m 2 ) plus a maximum of six 3-weekly cycles of cisplatin (80 or 100 mg/m 2 , day 1) or carboplatin (at an area under the curve of 5 mg/mL/min as a 1-h intravenous infusion on day 1) and 5-fluorouracil (800 or 1000 mg/m 2 /day, days 1-4). Patients with stable disease who received cetuximab plus platinum-based chemotherapy continued to receive cetuximab until disease progression or unacceptable toxicities, whichever occurred first. The median follow-up was 10.5 (range 1.2-34.2) months. The best overall response and the disease control rates were 46.2 and 67.7%, respectively. The median overall survival and progression-free survival rates were 12.1 and 7.8 months, respectively. The most common grades 3-4 adverse events were skin rash (9.2%) followed by leukopenia (6.2%). None of the adverse events were fatal. The results of our multicenter retrospective study, which was the largest of its kind to date, suggest that first-line cetuximab plus platinum-based chemotherapy is suitable and well-tolerated for the systemic therapy of recurrent or metastatic OSCC.

Factors predicting survival in ALS: a multicenter Italian study.

PubMed

Calvo, Andrea; Moglia, Cristina; Lunetta, Christian; Marinou, Kalliopi; Ticozzi, Nicola; Ferrante, Gianluca Drago; Scialo, Carlo; Sorarù, Gianni; Trojsi, Francesca; Conte, Amelia; Falzone, Yuri M; Tortelli, Rosanna; Russo, Massimo; Chiò, Adriano; Sansone, Valeria Ada; Mora, Gabriele; Silani, Vincenzo; Volanti, Paolo; Caponnetto, Claudia; Querin, Giorgia; Monsurrò, Maria Rosaria; Sabatelli, Mario; Riva, Nilo; Logroscino, Giancarlo; Messina, Sonia; Fini, Nicola; Mandrioli, Jessica

2017-01-01

The aim of this multicenter, retrospective study is to investigate the role of clinical characteristics and therapeutic intervention on ALS prognosis. The study included patients diagnosed from January 1, 2009 to December 31, 2013 in 13 Italian referral centers for ALS located in 10 Italian regions. Caring neurologists collected a detailed phenotypic profile and follow-up data until death into an electronic database. One center collected also data from a population-based registry for ALS. 2648 incident cases were collected. The median survival time from onset to death/tracheostomy was 44 months (SE 1.18, CI 42-46). According to univariate analysis, factors related to survival from onset to death/tracheostomy were: age at onset, diagnostic delay, site of onset, phenotype, degree of certainty at diagnosis according to revised El Escorial criteria (R-EEC), presence/absence of dementia, BMI at diagnosis, patients' provenance. In the multivariate analysis, age at onset, diagnostic delay, phenotypes but not site of onset, presence/absence of dementia, BMI, riluzole use, R-EEC criteria were independent prognostic factors of survival in ALS. We compared patients from an ALS Registry with patients from tertiary centers; the latter ones were younger, less frequently bulbar, but more frequently familial and definite at diagnosis. Our large, multicenter study demonstrated the role of some clinical and demographic factors on ALS survival, and showed some interesting differences between referral centers' patients and the general ALS population. These results can be helpful for clinical practice, in clinical trial design and to validate new tools to predict disease progression.

Systemic fluoroquinolone prescriptions for hospitalized children in Belgium, results of a multicenter retrospective drug utilization study.

PubMed

Meesters, Kevin; Mauel, Reiner; Dhont, Evelyn; Walle, Johan Vande; De Bruyne, Pauline

2018-02-23

Fluoroquinolones (FQ) are increasingly prescribed for children, despite being labeled for only a limited number of labeled pediatric indications. In this multicenter retrospective drug utilization study, we analyzed indications for systemic FQ prescriptions in hospitalized children and the appropriateness of the prescribed dose. Using data obtained from electronic medical files, the study included all children who received a systemic FQ prescription in two Belgian university children's hospitals between 2010 and 2013. Two authors reviewed prescribed daily doses. Univariate and multivariate logistic regression models were used to analyze risk factors for inadequately dosing. Results262 FQ prescriptions for individual patients were included for analysis. 16.8% of these prescriptions were for labeled indications, and 35.1% were guided by bacteriological findings. Prescribed daily dose was considered to be inappropriate in 79 prescriptions (30.2%). Other FQ than ciprofloxacin accounted for 9 prescriptions (3.4%), of which 8 were correctly dosed. Underdosing represented 45 (56.9%) dosing errors. Infants and preschool children were at particular risk for dosing errors, with associated adjusted OR of 0.263 (0.097-0.701) and 0.254 (0.106-0.588) respectively. FQ were often prescribed off-label and not guided by bacteriological findings in our study population. Dosing errors were common, particularly in infants and preschool children. FQ prescriptions for children should be improved by specific pediatric antimicrobial stewardship teams. Furthermore, pharmacokinetic studies should optimise dosing recommendations for children.

[Risk factors for thromboembolism in patients with atrial fibrillation during treatment with aspirin: a multicenter, cooperative retrospective study. Research Group for Antiarrhythmic Drug Therapy].

PubMed

2000-05-01

Warfarin is effective in preventing thromboembolism in patients with atrial fibrillation, but aspirin is frequently used as an alternative treatment. A multicenter, retrospective study was undertaken to identify patients at risk for thromboembolism during treatment with aspirin. The study group consisted of 470 patients (318 males, 152 females, mean age 59.9 +/- 11.8 years at initial examination) with atrial fibrillation who were treated with aspirin. Thirty-seven percent of patients had paroxysmal atrial fibrillation and 65% of patients received aspirin at a daily dose of 81 mg. Thromboembolism occurred in 31 patients (6.6%) during the follow-up period, resulting in cerebral infarction in 19 patients, transient ischemic attack in 7, and embolism of peripheral arteries in 5. Patients with thromboembolism had lower prevalence of New York Heart Association (NYHA) functional class I (52% vs 72%, p < 0.02) and paroxysmal atrial fibrillation (23% vs 38%, p = 0.085) compared with patients without thromboembolism. Multivariate analysis with the Cox proportional hazard model determined age (> or = 65 years, relative risk 2.29, p = 0.032) as an independent risk factor. NYHA functional class (> or = class II) tended to indicate an increased risk of thromboembolic events (relative risk 1.90, p = 0.076). These results suggest that aspirin has limited efficacy for prevention of thromboembolism in patients with atrial fibrillation who are old (> or = 65 years) or have symptomatic heart failure.

Long-term effects of edaravone on survival of patients with amyotrophic lateral sclerosis.

PubMed

Okada, Masamitsu; Yamashita, Satoshi; Ueyama, Hidetsugu; Ishizaki, Masatoshi; Maeda, Yasushi; Ando, Yukio

2018-06-01

Oxidative stress has been implicated in the pathogenesis of amyotrophic lateral sclerosis (ALS). Edaravone, a free radical scavenger, was approved as a therapeutic drug for ALS in 2015 in Japan. A phase 3 clinical trial demonstrated a smaller decline in ALS functional scale scores compared with placebo. However, the long-term effects of edaravone on ALS patients remain unclear. This study aimed to retrospectively investigate the long-term effects of edaravone on the survival of ALS patients. We retrospectively analyzed 27 consecutive patients with ALS who were treated with edaravone and 30 consecutive ALS patients who were not treated with edaravone between 2010 and 2016. The differences of ALSFRS-R scores from baseline to 6 months was significantly reduced in the edaravone group, compared to the control group. The changes in serum creatinine, as a possible marker of ALS severity, from baseline to 6 and 12 months were significantly improved in the edaravone group, compared to the control group. The survival rate was significantly improved in the edaravone group compared with control patients. Our retrospective single-center analysis suggests slower progression and better prognosis of ALS patients with edaravone treatment. Further investigation, including prospective multicenter analysis, is warranted to confirm the usefulness of edaravone for a better prognosis of ALS.

Dynamic changes in the hypothalamic-pituitary-adrenal axis during growth hormone therapy in children with growth hormone deficiency: a multicenter retrospective study.

PubMed

Wang, Limin; Wang, Qian; Li, Guimei; Liu, Wendong

2015-09-01

The objective of this study was to investigate changes in the hypothalamic-pituitary-adrenal (HPA) axis after recombinant human growth hormone (rhGH) therapy. Subjects included children with growth hormone deficiency (GHD). We conducted a multicenter, retrospective study that assessed 72 GHD patients treated with rhGH during 6 months. Patients were classified into two groups: isolated GHD (IGHD; n=20) and multiple pituitary hormone deficiencies (MPHD; n=52). The HPA axis and other hormones were evaluated at baseline and every 3 months. In the MPHD group, 32 patients had adrenocorticotrophic hormone deficiency and received hydrocortisone before rhGH therapy. In the other 20/52 MPHD patients, the cortisol (COR) level was significantly reduced after rhGH therapy. Moreover, 10 patients showed low COR levels. In the IGHD group, COR levels also decreased, but remained within the normal range. During rhGH therapy, COR levels were reduced, particularly in patients with MPHD. HPA axis should be monitored during rhGH therapy.

Diagnosis, Treatment and Long-Term Follow Up of Patients with ADA Deficiency: a Single-Center Experience.

PubMed

Baffelli, Renata; Notarangelo, Lucia D; Imberti, Luisa; Hershfield, Michael S; Serana, Federico; Santisteban, Ines; Bolda, Federica; Porta, Fulvio; Lanfranchi, Arnalda

2015-10-01

We carried out a retrospective analysis of 27 patients with Adenosine Deaminase (ADA) deficiency diagnosed in a single center from 1997 to the 2013, for evaluating whether data regarding types of disease-inducing mutations, biochemical and immunological features as well as clinical outcomes of patients treated with enzyme replacement or transplantation, were comparable to those obtained in multicenter studies. The ADA deficiency diagnosis was performed with biochemical, immunological and molecular techniques. Ten patients treated with hematopoietic stem cell transplantation and three in treatment with enzyme replacement were followed up in our center. Twenty-four different mutations were identified and five were not previously reported. Identical mutations were found among patients from the same Romani ethnic group or from the same geographical region. A more rapid recovery was observed in enzyme replacement treated patients in comparison with those transplanted that, however, showed a continuous and long-lasting improvement both in terms of immune and metabolic recovery. The data obtained in our single center are comparable with those that have been reported in multicenter surveys.

Prognosis after surgical treatment for pancreatic cancer in patients aged 80 years or older: a multicenter study.

PubMed

Sho, Masayuki; Murakami, Yoshiaki; Kawai, Manabu; Motoi, Fuyuhiko; Satoi, Sohei; Matsumoto, Ippei; Honda, Goro; Uemura, Kenichiro; Yanagimoto, Hiroaki; Kurata, Masanao; Akahori, Takahiro; Kinoshita, Shoichi; Nagai, Minako; Nishiwada, Satoshi; Fukumoto, Takumi; Unno, Michiaki; Yamaue, Hiroki; Nakajima, Yoshiyuki

2016-03-01

The optimal therapeutic strategy for very elderly pancreatic cancer patients remains to be determined. The aim of this study was to clarify the role of pancreatic resection in patients 80 years of age or older. A retrospective multicenter analysis of 1401 patients who had undergone pancreatic resection for pancreatic cancer was performed. The patients aged ≥ 80 years (n = 99) were compared with a control group <80 years of age (n = 1302). There were no significant differences in the postoperative complications and mortality between the two groups. However, the prognosis of octogenarians was poorer than that of younger patients for both resectable and borderline resectable tumors. Importantly, there were few long-term survivors in the elderly group, especially among those with borderline resectable pancreatic cancer. A multivariate analysis of the prognostic factors in the very elderly patients indicated that the completion of adjuvant chemotherapy was the only significant factor. In addition, preoperative albumin level was the only independent risk factor for a failure to complete adjuvant chemotherapy. This study demonstrates that the postoperative prognosis in octogenarian patients was not good as that in younger patients possibly due to less frequent completion of adjuvant chemotherapy. © 2016 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Safety of Endovascular Intervention for Stroke on Therapeutic Anticoagulation: Multicenter Cohort Study and Meta-Analysis.

PubMed

Kurowski, Donna; Jonczak, Karin; Shah, Qaisar; Yaghi, Shadi; Marshall, Randolph S; Ahmad, Haroon; McKinney, James; Torres, Jose; Ishida, Koto; Cucchiara, Brett

2017-05-01

Intravenous (IV) tissue plasminogen activator (tPA) is contraindicated in therapeutically anti-coagulated patients. Such patients may be considered for endovascular intervention. However, there are limited data on its safety. We performed a multicenter retrospective study of patients undergoing endovascular intervention for acute ischemic stroke while on therapeutic anticoagulation. We compared the observed rate of National Institute of Neurological Disorders and Stroke defined symptomatic intracerebral hemorrhage (sICH) with risk-adjusted historical control rates of sICH after IV tPA using weighted averages of the hemorrhage after thrombolysis (HAT) and Multicenter Stroke Survey (MSS) prediction scores. We also performed a metaanalysis of studies assessing risk of sICH with endovascular intervention in patients on anticoagulation. Of 94 cases, mean age was 73 years and median National Institutes of Health Stroke Scale was 19. Anticoagulation consisted of warfarin (n = 51), dabigatran (n = 6), rivaroxaban (n = 13), apixaban (n = 1), IV heparin (n = 19), low molecular weight heparin (n = 3), and combined warfarin and IV heparin (n = 3). sICH was seen in 7 patients (7%, 95% confidence interval 4-15), all on warfarin. Predicted sICH rates for the cohort based on HAT and MSS scoring were 12% and 7%, respectively. Meta-analysis of 6 studies showed no significant difference in sICH between patients undergoing endovascular intervention on anticoagulation and comparator groups. Endovascular intervention in subjects on therapeutic anticoagulation appears reasonably safe, with a sICH rate similar to patients not on anticoagulation receiving IV tPA. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

A Multicenter Retrospective Survey of Refractive Surgery in 78,248 Eyes.

PubMed

Kamiya, Kazutaka; Igarashi, Akihito; Hayashi, Ken; Negishi, Kazuno; Sato, Masaki; Bissen-Miyajima, Hiroko

2017-09-01

To retrospectively evaluate the current practice, trends, and outcomes of refractive surgery in Japan. This multicenter survey comprised 78,248 eyes of 39,727 consecutive patients who underwent refractive surgery at 45 major institutions in Japan. The corresponding ophthalmologists responded to a selfadministered questionnaire. The authors especially evaluated the safety, efficacy, predictability, stability, and adverse events of LASIK and phakic intraocular lens (IOL) implantation 3 months postoperatively. The most common refractive surgery was LASIK (90.9%), followed by corneal inlay (5.0%), posterior chamber phakic IOL implantation (1.3%), laser-assisted subepithelial keratomileusis (1.0%), refractive lens exchange (0.9%), photorefractive keratectomy (0.3%), and refractive lenticule extraction (0.2%). For subgroup analysis, 69,987 eyes (99.5%) and 67,512 eyes (95.9%) achieved corrected and uncorrected distance visual acuity of 20/20 or better, respectively, after LASIK, and 935 eyes (98.8%) and 890 eyes (94.1%), respectively, after phakic IOL implantation. There were 69,176 eyes (98.3%) and 908 eyes (96.0%) within ±1.00 diopter (D) of the attempted correction after LASIK and phakic IOL implantation, respectively. There were 1,926 eyes (2.7%) and 1 eye (0.1%) with changes in refraction of 1.00 D or less from 1 week to 3 months after LASIK and phakic IOL implantation, respectively. No vision-threatening complications occurred in any case. According to this survey, LASIK remains the most prevalent surgical technique in Japan. Both LASIK and phakic IOL implantation offered good safety and efficacy outcomes, yielding predictable and stable results. [J Refract Surg. 2017;33(9):598-602.]. Copyright 2017, SLACK Incorporated.

QIN DAWG Validation of Gradient Nonlinearity Bias Correction Workflow for Quantitative Diffusion-Weighted Imaging in Multicenter Trials.

PubMed

Malyarenko, Dariya I; Wilmes, Lisa J; Arlinghaus, Lori R; Jacobs, Michael A; Huang, Wei; Helmer, Karl G; Taouli, Bachir; Yankeelov, Thomas E; Newitt, David; Chenevert, Thomas L

2016-12-01

Previous research has shown that system-dependent gradient nonlinearity (GNL) introduces a significant spatial bias (nonuniformity) in apparent diffusion coefficient (ADC) maps. Here, the feasibility of centralized retrospective system-specific correction of GNL bias for quantitative diffusion-weighted imaging (DWI) in multisite clinical trials is demonstrated across diverse scanners independent of the scanned object. Using corrector maps generated from system characterization by ice-water phantom measurement completed in the previous project phase, GNL bias correction was performed for test ADC measurements from an independent DWI phantom (room temperature agar) at two offset locations in the bore. The precomputed three-dimensional GNL correctors were retrospectively applied to test DWI scans by the central analysis site. The correction was blinded to reference DWI of the agar phantom at magnet isocenter where the GNL bias is negligible. The performance was evaluated from changes in ADC region of interest histogram statistics before and after correction with respect to the unbiased reference ADC values provided by sites. Both absolute error and nonuniformity of the ADC map induced by GNL (median, 12%; range, -35% to +10%) were substantially reduced by correction (7-fold in median and 3-fold in range). The residual ADC nonuniformity errors were attributed to measurement noise and other non-GNL sources. Correction of systematic GNL bias resulted in a 2-fold decrease in technical variability across scanners (down to site temperature range). The described validation of GNL bias correction marks progress toward implementation of this technology in multicenter trials that utilize quantitative DWI.

QIN DAWG Validation of Gradient Nonlinearity Bias Correction Workflow for Quantitative Diffusion-Weighted Imaging in Multicenter Trials

PubMed Central

Malyarenko, Dariya I.; Wilmes, Lisa J.; Arlinghaus, Lori R.; Jacobs, Michael A.; Huang, Wei; Helmer, Karl G.; Taouli, Bachir; Yankeelov, Thomas E.; Newitt, David; Chenevert, Thomas L.

2017-01-01

Previous research has shown that system-dependent gradient nonlinearity (GNL) introduces a significant spatial bias (nonuniformity) in apparent diffusion coefficient (ADC) maps. Here, the feasibility of centralized retrospective system-specific correction of GNL bias for quantitative diffusion-weighted imaging (DWI) in multisite clinical trials is demonstrated across diverse scanners independent of the scanned object. Using corrector maps generated from system characterization by ice-water phantom measurement completed in the previous project phase, GNL bias correction was performed for test ADC measurements from an independent DWI phantom (room temperature agar) at two offset locations in the bore. The precomputed three-dimensional GNL correctors were retrospectively applied to test DWI scans by the central analysis site. The correction was blinded to reference DWI of the agar phantom at magnet isocenter where the GNL bias is negligible. The performance was evaluated from changes in ADC region of interest histogram statistics before and after correction with respect to the unbiased reference ADC values provided by sites. Both absolute error and nonuniformity of the ADC map induced by GNL (median, 12%; range, −35% to +10%) were substantially reduced by correction (7-fold in median and 3-fold in range). The residual ADC nonuniformity errors were attributed to measurement noise and other non-GNL sources. Correction of systematic GNL bias resulted in a 2-fold decrease in technical variability across scanners (down to site temperature range). The described validation of GNL bias correction marks progress toward implementation of this technology in multicenter trials that utilize quantitative DWI. PMID:28105469

Canary TMA — EDRN Public Portal

Cancer.gov

This protocol describes a multi-center, retrospective, case-cohort tissue microarray (TMA) study to evaluate tissue biomarkers for their ability to predict recurrent prostate cancer at the time of radical prostatectomy (RP). Candidate biomarkers will be assessed by performing tissue localization studies on TMAs containing recurrent prostate cancer and non-recurrent prostate cancer. De-identified data will be transferred to a central repository for statistical analysis. Participating institutions will use a variation of case-cohort sampling to randomly select a subset of patients from a retrospectively constructed RP cohort and/or perform selected assays on the cohort. The study endpoint is time to recurrence; of primary interest is five year recurrence free survival. Recurrent prostate cancer is defined by 1) a single serum prostate-specific antigen (PSA) level greater than 0.2 ng/mL after RP and/or 2) receipt of salvage or secondary therapy after RP and/or 3) clinical or radiological evidence of metastatic disease. Non-recurrent prostate cancer is defined as disease with no evidence of recurrence.

Resective surgical approach shows a high performance in the management of advanced cases of bisphosphonate-related osteonecrosis of the jaws: a retrospective survey of 347 cases.

PubMed

Graziani, Filippo; Vescovi, Paolo; Campisi, Giuseppina; Favia, Gianfranco; Gabriele, Mario; Gaeta, Giovanni Maria; Gennai, Stefano; Goia, Franco; Miccoli, Mario; Peluso, Franco; Scoletta, Matteo; Solazzo, Luigi; Colella, Giuseppe

2012-11-01

The aim of this study was to evaluate the results of the surgical treatment of bisphosphonate-related osteonecrosis of the jaw (BRONJ) in a large cohort. A retrospective cohort multicenter study was designed. Patients were enrolled if they were diagnosed with BRONJ and received operative treatment. Data on demographic, health status, perioperative, and surgical factors were collected retrospectively. The primary outcome variable was a change in BRONJ staging (improvement, worsening, or no change). Interventions were grouped by local debridement and resective surgery. Data were collected for other variables as cofactors. Univariate analysis and logistic regressions were then performed. Of the 347 BRONJ-affected subjects, 59% showed improvement, 30% showed no change, and 11% showed worsening. Improvement was observed in 49% of cases treated with local debridement and 68% of cases treated with resective surgery. Multivariate analysis indicated that maxillary location, resective surgery, and no additional corticosteroid treatment were associated with a positive outcome. Surgical treatment of BRONJ appeared to be more effective when resective procedures were performed. Nonetheless, other factors, such as the absence of symptoms and the types of drug administration, should be taken into account before clinical decisions are made. Copyright © 2012 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Long-Term Renal Function Recovery following Radical Nephrectomy for Kidney Cancer: Results from a Multicenter Confirmatory Study.

PubMed

Zabor, Emily C; Furberg, Helena; Lee, Byron; Campbell, Steven; Lane, Brian R; Thompson, R Houston; Antonio, Elvis Caraballo; Noyes, Sabrina L; Zaid, Harras; Jaimes, Edgar A; Russo, Paul

2018-04-01

We sought to confirm the findings from a previous single institution study of 572 patients from Memorial Sloan Kettering Cancer Center in which we found that 49% of patients recovered to the preoperative estimated glomerular filtration rate within 2 years following radical nephrectomy for renal cell carcinoma. A multicenter retrospective study was performed in 1,928 patients using data contributed from 3 independent centers. The outcome of interest was postoperative recovery to the preoperative estimated glomerular filtration rate. Data were analyzed using cumulative incidence and competing risks regression with death from any cause treated as a competing event. This study demonstrated that 45% of patients had recovered to the preoperative estimated glomerular filtration rate by 2 years following radical nephrectomy. Furthermore, this study confirmed that recovery of renal function differed according to preoperative renal function such that patients with a lower preoperative estimated glomerular filtration rate had an increased chance of recovery. This study also suggested that larger tumor size and female gender were significantly associated with an increased chance of renal function recovery. In this multicenter retrospective study we confirmed that in the long term a large proportion of patients recover to preoperative renal function following radical nephrectomy for kidney tumors. Recovery is more likely among those with a lower preoperative estimated glomerular filtration rate. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Prospective Validation of Objective Prognostic Score for Advanced Cancer Inpatients in South Korea: A Multicenter Study.

PubMed

Yoon, Seok Joon; Suh, Sang-Yeon; Lee, Yong Joo; Park, Jeanno; Hwang, Sunwook; Lee, Sanghee Shiny; Ahn, Hong Yup; Koh, Su-Jin; Park, Keon Uk

2017-01-01

Objective Prognostic Score (OPS) was developed as an easy and simple prognosticating tool in South Korea. It has been validated retrospectively in a single center in South Korea. We aimed to validate the OPS prospectively for advanced cancer inpatients in South Korea using a multicenter study. This was a prospective cohort study. We enrolled 243 advanced cancer patients admitted in five palliative care units in South Korea from May 2013 till March 2015. Seven members of the Korean Palliative Medicine Research Network who are experts of palliative care led the study. Clinical variables (dyspnea/anorexia/performance status) and laboratory variables (total leukocyte counts/serum total bilirubin/serum creatinine/lactate dehydrogenase) were collected at the enrollment. Survival time was calculated as days from enrollment to death during admission. A total of 217 patients were included in the final analysis (feasibility: 89.3%). Survival time of the higher OPS group (OPS ≥3) and the lower OPS group (OPS <3) was 10.0 (95% confidence interval (CI) 7.72-12.28) days and 32.0 (95% CI 25.44-38.56) days, respectively. There were significant differences between the 2 groups (p < 0.001). Overall accuracy of OPS ≥3 for predicting survival less than three weeks was 71.0%. OPS was successfully validated using a prospective multicenter study in South Korea. It is a useful method to predict three-week survival of Korean inpatients with advanced cancer.

Candidacy for Bilateral Hearing Aids: A Retrospective Multicenter Study

ERIC Educational Resources Information Center

Boymans, Monique; Goverts, S. Theo; Kramer, Sophia E.; Festen, Joost M.; Dreschler, Wouter A.

2009-01-01

Purpose: The goal of this study was to find factors for refining candidacy criteria for bilateral hearing aid fittings. Clinical files of 1,000 consecutive hearing aid fittings were analyzed. Method: Case history, audiometric, and rehabilitation data were collected from clinical files, and an extensive questionnaire on long-term outcome measures…

A Multicenter Radiographic Evaluation of the Rates of Preoperative and Postoperative Malalignment in Degenerative Spinal Fusions.

PubMed

Leveque, Jean-Christophe A; Segebarth, Bradley; Schroerlucke, Samuel R; Khanna, Nitin; Pollina, John; Youssef, Jim A; Tohmeh, Antoine G; Uribe, Juan S

2018-07-01

Multicenter, retrospective, institutional-review-board -approved study at 18 institutions in the United States with 24 treating investigators. This study was designed to retrospectively assess the prevalence of spinopelvic malalignment in patients who underwent one- or two-level lumbar fusions for degenerative (nondeformity) indications and to assess the incidence of malalignment after fusion surgery as well as the rate of alignment preservation and/or correction in this population. Spinopelvic malalignment after lumbar fusion has been associated with lower postoperative health-related quality of life and elevated risk of adjacent segment failure. The prevalence of spinopelvic malalignment in short-segment degenerative lumbar fusion procedures from a large sample of patients is heretofore unreported and may lead to an under-appreciation of these factors in surgical planning and ultimate preservation or correction of alignment. Lateral preoperative and postoperative lumbar radiographs were retrospectively acquired from 578 one- or two-level lumbar fusion patients and newly measured for lumbar lordosis (LL), pelvic incidence (PI), and pelvic tilt. Patients were categorized at preop and postop time points as aligned if PI-LL < 10° or malaligned if PI-LL≥10°. Patients were grouped into categories based on their alignment progression from pre- to postoperative, with preserved (aligned to aligned), restored (malaligned to aligned), not corrected (malaligned to malaligned), and worsened (aligned to malaligned) designations. Preoperatively, 173 (30%) patients exhibited malalignment. Postoperatively, 161 (28%) of patients were malaligned. Alignment was preserved in 63%, restored in 9%, not corrected in 21%, and worsened in 7% of patients. This is the first multicenter study to evaluate the preoperative prevalence and postoperative incidence of spinopelvic malalignment in a large series of short-segment degenerative lumbar fusions, finding over 25% of patients out of alignment at both time points, suggesting that alignment preservation/restoration considerations should be incorporated into the decision-making of even degenerative lumbar spinal fusions. 3.

German Multicenter Study Investigating 177Lu-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients.

PubMed

Rahbar, Kambiz; Ahmadzadehfar, Hojjat; Kratochwil, Clemens; Haberkorn, Uwe; Schäfers, Michael; Essler, Markus; Baum, Richard P; Kulkarni, Harshad R; Schmidt, Matthias; Drzezga, Alexander; Bartenstein, Peter; Pfestroff, Andreas; Luster, Markus; Lützen, Ulf; Marx, Marlies; Prasad, Vikas; Brenner, Winfried; Heinzel, Alexander; Mottaghy, Felix M; Ruf, Juri; Meyer, Philipp Tobias; Heuschkel, Martin; Eveslage, Maria; Bögemann, Martin; Fendler, Wolfgang Peter; Krause, Bernd Joachim

2017-01-01

177 Lu-labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castration-resistant prostate cancer (mCRPC). Initiated by the German Society of Nuclear Medicine, a retrospective multicenter data analysis was started in 2015 to evaluate efficacy and safety of 177 Lu-PSMA-617 in a large cohort of patients. One hundred forty-five patients (median age, 73 y; range, 43-88 y) with mCRPC were treated with 177 Lu-PSMA-617 in 12 therapy centers between February 2014 and July 2015 with 1-4 therapy cycles and an activity range of 2-8 GBq per cycle. Toxicity was categorized by the common toxicity criteria for adverse events (version 4.0) on the basis of serial blood tests and the attending physician's report. The primary endpoint for efficacy was biochemical response as defined by a prostate-specific antigen decline ≥ 50% from baseline to at least 2 wk after the start of RLT. A total of 248 therapy cycles were performed in 145 patients. Data for biochemical response in 99 patients as well as data for physician-reported and laboratory-based toxicity in 145 and 121 patients, respectively, were available. The median follow-up was 16 wk (range, 2-30 wk). Nineteen patients died during the observation period. Grade 3-4 hematotoxicity occurred in 18 patients: 10%, 4%, and 3% of the patients experienced anemia, thrombocytopenia, and leukopenia, respectively. Xerostomia occurred in 8%. The overall biochemical response rate was 45% after all therapy cycles, whereas 40% of patients already responded after a single cycle. Elevated alkaline phosphatase and the presence of visceral metastases were negative predictors and the total number of therapy cycles positive predictors of biochemical response. The present retrospective multicenter study of 177 Lu-PSMA-617 RLT demonstrates favorable safety and high efficacy exceeding those of other third-line systemic therapies in mCRPC patients. Future phase II/III studies are warranted to elucidate the survival benefit of this new therapy in patients with mCRPC. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.

[Demographic Analysis of Patients with Osteosarcoma, Chonddrosarcoma, Ewing's Sarcoma from one Sarcoma Center in Switzerland].

PubMed

Hodel, Sandro; Seeli, Franziska; Fuchs, Bruno

2015-06-17

Retrospective analysis of presentation, diagnosis and outcome of patients with osteosarcoma, chondrosarcoma and Ewing's sarcoma was performed for a single Sarcoma Center in Zurich at the University Hospital Balgrist. 201 patients were included. Overall survival at five and ten years were 74 ± 6%, 69 ± 7% for osteosarcoma (n = 85, since 2000), 85 ± 7%, 80 ± 9% for Ewing's sarcoma (n = 43, since 1990) and 86 ± 5%, 78 ± 9% for chondrosarcoma (n = 73, since 2000). The here presented overall survival rates from a single Sarcoma Center in Switzerland appear to be equivalent to other large international monocenter studies. The presentation and epidemiology of these patients are in accordance with large multicenter epidemiological studies. A nationwide sarcoma database (SwissSARCOS; www.sarcoma.ch) seems indispensable for more detailed analysis and quality management in such rare diseases.

Switching From Donepezil to Rivastigmine Is Well Tolerated: Results of an Open-Label Safety and Tolerability Study

PubMed Central

Sadowsky, Carl H.; Farlow, Martin R.; Atkinson, Leone; Steadman, Jennifer; Koumaras, Barbara; Chen, Michael; Mirski, Dario

2005-01-01

Background: Transitioning patients between cholinesterase inhibitors was thought to require a washout period to avoid cholinergic toxicity; however, evidence suggests that abrupt discontinuation of donepezil may lead to cognitive decline. We evaluated the safety and tolerability of an immediate switch from donepezil to rivastigmine. Method: This is an analysis of the safety and tolerability data from the first 28 days of an open-label, multicenter, prospective trial, conducted from August 2002 to August 2003, in which patients satisfying NINCDS-ADRDA criteria for probable Alzheimer's disease were administered rivastigmine 1.5 mg b.i.d. within 24 to 36 hours of donepezil discontinuation. Results are compared with adverse event rates from a retrospective analysis of a pivotal, placebo-controlled trial examining patients not previously treated with a cholinesterase inhibitor. Results: Fifty-eight of 61 patients completed the first 28 days, with no suspected drug-related discontinuations during this period. Incidence of overall gastrointestinal adverse events at day 7 was 8.2%, and at day 28 was 11.5%. The corresponding rate for rivastigmine-treated patients in the retrospective analysis of the pivotal trial for day 7 was 3.3%. Conclusion: These study results suggest that transitioning patients from donepezil to rivastigmine without a washout period is safe and well tolerated. PMID:15841194

Effect of perioperative oral care on prevention of postoperative pneumonia associated with esophageal cancer surgery: A multicenter case-control study with propensity score matching analysis.

PubMed

Soutome, Sakiko; Yanamoto, Souichi; Funahara, Madoka; Hasegawa, Takumi; Komori, Takahide; Yamada, Shin-Ichi; Kurita, Hiroshi; Yamauchi, Chika; Shibuya, Yasuyuki; Kojima, Yuka; Nakahara, Hirokazu; Oho, Takahiko; Umeda, Masahiro

2017-08-01

The aim of this study was to investigate the effectiveness of oral care in prevention of postoperative pneumonia associated with esophageal cancer surgery.Postoperative pneumonia is a severe adverse event associated with esophageal cancer surgery. It is thought to be caused by aspiration of oropharyngeal fluid containing pathogens. However, the relationship between oral health status and postoperative pneumonia has not been well investigated.This study included 539 patients with esophageal cancer undergoing surgery at 1 of 7 university hospitals. While 306 patients received perioperative oral care, 233 did not. Various clinical factors as well as occurrence of postoperative pneumonia were retrospectively evaluated. Propensity-score matching was performed to minimize selection biases associated with comparison of retrospective data between the oral care and control groups. Factors related to postoperative pneumonia were analyzed by logistic regression analysis.Of the original 539 patients, 103 (19.1%) experienced postoperative pneumonia. The results of multivariate analysis of the 420 propensity score-matched patients revealed longer operation time, postoperative dysphagia, and lack of oral care intervention to be significantly correlated with postoperative pneumonia.The present findings demonstrate that perioperative oral care can reduce the risk of postoperative pneumonia in patients undergoing esophageal cancer surgery.

BIOCHEMICAL CONTROL DURING LONG-TERM FOLLOW-UP OF 230 ADULT PATIENTS WITH CUSHING DISEASE: A MULTICENTER RETROSPECTIVE STUDY.

PubMed

Geer, Eliza B; Shafiq, Ismat; Gordon, Murray B; Bonert, Vivien; Ayala, Alejandro; Swerdloff, Ronald S; Katznelson, Laurence; Lalazar, Yelena; Manuylova, Ekaterina; Pulaski-Liebert, Karen J; Carmichael, John D; Hannoush, Zeina; Surampudi, Vijaya; Broder, Michael S; Cherepanov, Dasha; Eagan, Marianne; Lee, Jackie; Said, Qayyim; Neary, Maureen P; Biller, Beverly M K

2017-08-01

Cushing disease (CD) results from excessive exposure to glucocorticoids caused by an adrenocorticotropic hormone-secreting pituitary tumor. Inadequately treated CD is associated with significant morbidity and elevated mortality. Multicenter data on CD patients treated in routine clinical practice are needed to assess treatment outcomes in this rare disorder. The study purpose was to describe the burden of illness and treatment outcomes for CD patients. Eight pituitary centers in four U.S. regions participated in this multicenter retrospective chart review study. Subjects were CD patients diagnosed at ≥18 years of age within the past 20 years. Descriptive statistical analyses were conducted to examine presenting signs, symptoms, comorbidities, and treatment outcomes. Of 230 patients, 79% were female (median age at diagnosis, 39 years; range, 18 to 78 years). Length of follow-up was 0 to 27.5 years (median, 1.9 years). Pituitary adenomas were 0 to 51 mm. The most common presenting comorbidities included hypertension (67.3%), polycystic ovary syndrome (43.5%), and hyperlipidemia (41.5%). Biochemical control was achieved with initial pituitary surgery in 41.4% patients (91 of 220), not achieved in 50.0% of patients (110 of 220), and undetermined in 8.6% of patients (19 of 220). At the end of follow-up, control had been achieved with a variety of treatment methods in 49.1% of patients (110 of 224), not achieved in 29.9% of patients (67 of 224), and undetermined in 21.0% of patients (47 of 224). Despite multiple treatments, at the end of follow-up, biochemical control was still not achieved in up to 30% of patients. These multicenter data demonstrate that in routine clinical practice, initial and long-term control is not achieved in a substantial number of patients with CD. BLA = bilateral adrenalectomy CD = Cushing disease CS = Cushing syndrome eCRF = electronic case report form MRI = magnetic resonance imaging PCOS = polycystic ovary syndrome.

Changes in oncological outcomes after radical nephroureterectomy in patients with upper urinary tract urothelial carcinoma treated in the last two decades: a retrospective analysis based on a multicenter collaborative study.

PubMed

Miyake, Makito; Tatsumi, Yoshihiro; Fujimoto, Kiyohide; Nagao, Kazuhiro; Sakano, Shigeru; Matsuyama, Hideyasu; Inamoto, Teruo; Azuma, Haruhito; Yasumoto, Hiroaki; Shiina, Hiroaki

2016-12-01

We investigated chronological changes in the outcomes of patients with upper urinary tract urothelial carcinoma treated in the past two decades, during which there was an important change in treatment paradigm. A retrospective review was conducted of 1180 urinary tract urothelial carcinoma patients who underwent radical nephroureterectomy in multicenter collaborative institutions between 1996 and 2015. The patients were divided into four groups according to the year when radical nephroureterectomy was performed, as follows: 1996-2000 (period 1; P1), 2001-05 (P2), 2006-10 (P3) and 2011-15 (P4). Variables including tumor grade, T and N categories, administration of perioperative chemotherapy and treatment outcomes were compared among the four groups. There were 146 (12%), 312 (27%), 459 (39%) and 263 (22%) patients in the P1, P2, P3 and P4 groups, respectively. The proportion of patients harboring pT2/3 and Grade 3 tumors increased gradually from 42% (P1) to 58% (P4) and from 49% (P1) to 65% (P4), respectively. The 5-year disease-free survival rates were 74%, 74%, 73% and 75%, and the 5-year overall survival rates were 74%, 65%, 67% and 72% for the P1, P2, P3, and P4 groups, respectively. Multivariate analysis with adjustment for possible confounding factors revealed no significant differences in disease-specific survival, overall survival or intravesical recurrence-free survival among the four groups. Despite advances in diagnostic instruments, surgery and systemic chemotherapy, the clinical outcome of urinary tract urothelial carcinoma after radical surgery has not significantly improved over the last two decades, and further research is therefore required. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Determining the Threshold for HbA1c as a Predictor for Adverse Outcomes After Total Joint Arthroplasty: A Multicenter, Retrospective Study.

PubMed

Tarabichi, Majd; Shohat, Noam; Kheir, Michael M; Adelani, Muyibat; Brigati, David; Kearns, Sean M; Patel, Pankajkumar; Clohisy, John C; Higuera, Carlos A; Levine, Brett R; Schwarzkopf, Ran; Parvizi, Javad; Jiranek, William A

2017-09-01

Although HbA1c is commonly used for assessing glycemic control before surgery, there is no consensus regarding its role and the appropriate threshold in predicting adverse outcomes. This study was designed to evaluate the potential link between HbA1c and subsequent periprosthetic joint infection (PJI), with the intention of determining the optimal threshold for HbA1c. This is a multicenter retrospective study, which identified 1645 diabetic patients who underwent primary total joint arthroplasty (1004 knees and 641 hips) between 2001 and 2015. All patients had an HbA1c measured within 3 months of surgery. The primary outcome of interest was a PJI at 1 year based on the Musculoskeletal Infection Society criteria. Secondary outcomes included orthopedic (wound and mechanical complications) and nonorthopedic complications (sepsis, thromboembolism, genitourinary, and cardiovascular complications). A regression analysis was performed to determine the independent influence of HbA1c for predicting PJI. Overall 22 cases of PJI occurred at 1 year (1.3%). HbA1c at a threshold of 7.7 was distinct for predicting PJI (area under the curve, 0.65; 95% confidence interval, 0.51-0.78). Using this threshold, PJI rates increased from 0.8% (11 of 1441) to 5.4% (11 of 204). In the stepwise logistic regression analysis, PJI remained the only variable associated with higher HbA1c (odds ratio, 1.5; confidence interval, 1.2-2.0; P = .0001). There was no association between high HbA1c levels and other complications assessed. High HbA1c levels are associated with an increased risk for PJI. A threshold of 7.7% seems to be more indicative of infection than the commonly used 7% and should perhaps be the goal in preoperative patient optimization. Copyright © 2017 Elsevier Inc. All rights reserved.

Retrospective multicenter evaluation of the "fly-catching syndrome" in 24 dogs: EEG, BAER, MRI, CSF findings and response to antiepileptic and antidepressant treatment.

PubMed

Wrzosek, Marcin; Płonek, Marta; Nicpoń, Józef; Cizinauskas, Sigitas; Pakozdy, Akos

2015-12-01

The fly-catching syndrome (FCS) is a rare canine condition of sudden, occasional, or constant episodes of biting the air. It may be accompanied by jumping, licking, and swallowing. The etiology of FCS is unknown and controversial. Various explanations for its occurrence have included epileptoid disorders such as visual cortex epileptiform disturbances and simple and complex partial seizures as well as compulsive disorders, hallucinatory behavior, and stereotypy. A retrospective multicenter analysis of 24 dogs with clinical symptoms of FCS is presented. Clinical signs at the time of presentation, the mean age at onset of the disease, the response to treatment, and the clinical outcome were recorded and analyzed in all patients. All dogs underwent clinical, neurological, and otoscopic examinations. Complete blood cell counts (CBCs) and serum chemistry panels were obtained from each dog. Diagnostic testing included MRI and EEG examinations in 21 cases, BAER in 19 cases, and CSF analysis in 20 cases. The EEG revealed spike activity in 8 (38%) of the 21 cases, 7 of which had activity in the occipital lobes. The brainstem auditory evoked response (BAER) revealed three cases of bilateral deafness. The MRI revealed six cases of Chiari malformation (CM), one case of syringohydromyelia (SM), and one case of a falx cerebri meningioma. The dogs were divided into groups according to their treatment protocol. Group A included dogs treated with phenobarbital (PB), and group B consisted of dogs treated with fluoxetine (FLX). Thirty-six percent of the dogs in group A responded to PB, while 100% of the dogs in group B responded to FLX. The results suggest that FCS is more responsive to FLX than PB. However, the etiology of this behavior remains unclear in most cases. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Clinical characteristics and outcomes of Castleman disease: A multicenter study of 185 Chinese patients.

PubMed

Zhang, Xuanye; Rao, Huilan; Xu, Xiaolu; Li, Zhihua; Liao, Bing; Wu, Hongmei; Li, Mei; Tong, Xiuzhen; Li, Juan; Cai, Qingqing

2018-01-01

Castleman disease (CD) is a rare lymphoproliferative disorder. To assess the clinical features, outcomes, and prognostic factors of this disease, we retrospectively analyzed 185 HIV-negative CD patients from four medical centers in southern China. The median age was 37 years. One hundred and twenty-one patients (65.4%) were classified as unicentric CD (UCD) and 64 patients (34.6%) were classified as multicentric CD (MCD). The histology subtype was hyaline-vascular for 132 patients (71.4%), plasma cell for 50 patients (27%), and mixed type for 3 patients (1.6%). The 5-year overall survival (OS) of 185 CD cases was 80.3%. All UCD patients underwent surgical excision, whereas the treatment strategies of MCD patients were heterogeneous. The outcome for UCD patients was better than MCD patients, with 5-year OS rates of 93.6% and 51.2%, respectively. In further analysis of the MCD subgroup, a multivariate analysis using a Cox regression model revealed that age, splenomegaly and pretreatment serum albumin level were independent prognostic factors for OS. This multicenter study comprising the largest sample size to date suggested that MCD is a distinct entity from UCD with a significantly worse outcome. Older age (≥40 years), splenomegaly, and hypoalbuminemia were risk factors for poorer MCD prognosis. © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Second-line chemotherapy in advanced biliary cancer progressed to first-line platinum-gemcitabine combination: a multicenter survey and pooled analysis with published data.

PubMed

Fornaro, Lorenzo; Vivaldi, Caterina; Cereda, Stefano; Leone, Francesco; Aprile, Giuseppe; Lonardi, Sara; Silvestris, Nicola; Santini, Daniele; Milella, Michele; Caparello, Chiara; Musettini, Gianna; Pasquini, Giulia; Falcone, Alfredo; Brandi, Giovanni; Sperduti, Isabella; Vasile, Enrico

2015-12-23

After progression to a standard first-line platinum and gemcitabine combination (GP), there is no established second-line therapy for patients with advanced biliary tract cancers (aBTC). Indeed, literature data suggest limited activity of most second-line agents evaluated so far. We collected a large retrospective series of aBTC patients treated with second-line chemotherapy after progression to a first-line GP regimen at different Italian institutions. We then pooled the data with those reported in previous studies, which were identified with a Medline search and the on-line abstract datasets of major international oncology meetings. A total of 174 patients were included in the multicenter survey: response rate (RR) with second-line chemotherapy was low (3.4 %), with median PFS and OS of 3.0 months and 6.6 months, respectively. At multivariate analysis, preserved performance status, low CA19.9 levels and absence of distant metastases were favorable prognostic factors. Data from other five presented or published series were identified, for a total of 499 patients included in the pooled analysis. The results confirmed marginal activity of second-line chemotherapy (RR: 10.2 %), with limited efficacy in unselected patient populations (median PFS: 3.1 months; median OS: 6.3 months). The current analysis highlights the limited value of second-line chemotherapy after a first-line GP combination in aBTC. While waiting for effective biologic agents in this setting, ongoing randomized trials will identify the optimal second-line chemotherapy regimen and validate prognostic factors for individual patient management.

Multicenter study of endoscopic preoperative biliary drainage for malignant hilar biliary obstruction: E-POD hilar study.

PubMed

Nakai, Yousuke; Yamamoto, Ryuichi; Matsuyama, Masato; Sakai, Yuji; Takayama, Yukiko; Ushio, Jun; Ito, Yukiko; Kitamura, Katsuya; Ryozawa, Shomei; Imamura, Tsunao; Tsuchida, Kouhei; Hayama, Jo; Itoi, Takao; Kawaguchi, Yoshiaki; Yoshida, Yu; Sugimori, Kazuya; Shimura, Kenji; Mizuide, Masafumi; Iwai, Tomohisa; Nishikawa, Ko; Yagioka, Hiroshi; Nagahama, Masatsugu; Toda, Nobuo; Saito, Tomotaka; Yasuda, Ichiro; Hirano, Kenji; Togawa, Osamu; Nakamura, Kenji; Maetani, Iruru; Sasahira, Naoki; Isayama, Hiroyuki

2018-05-01

Endoscopic nasobiliary drainage (ENBD) is often recommended in preoperative biliary drainage (PBD) for hilar malignant biliary obstruction (MBO), but endoscopic biliary stent (EBS) is also used in the clinical practice. We conducted this large-scale multicenter study to compare ENBD and EBS in this setting. A total of 374 cases undergoing PBD including 281 ENBD and 76 EBS for hilar MBO in 29 centers were retrospectively studied. Extrahepatic cholangiocarcinoma (ECC) accounted for 69.8% and Bismuth-Corlette classification was III or more in 58.8% of the study population. Endoscopic PBD was technically successful in 94.6%, and adverse event rate was 21.9%. The rate of post-endoscopic retrograde cholangiopancreatography pancreatitis was 16.0%, and non-endoscopic sphincterotomy was the only risk factor (odds ratio [OR] 2.51). Preoperative re-intervention was performed in 61.5%: planned re-interventions in 48.4% and unplanned re-interventions in 31.0%. Percutaneous transhepatic biliary drainage was placed in 6.4% at the time of surgery. The risk factors for unplanned procedures were ECC (OR 2.64) and total bilirubin ≥ 10 mg/dL (OR 2.18). In surgically resected cases, prognostic factors were ECC (hazard ratio [HR] 0.57), predraiange magnetic resonance cholangiopancreatography (HR 1.62) and unplanned re-interventions (HR 1.81). EBS was not associated with increased adverse events, unplanned re-interventions, or a poor prognosis. Our retrospective analysis did not demonstrate the advantage of ENBD over EBS as the initial PBD for resectable hilar MBO. Although the technical success rate of endoscopic PBD was high, its re-intervention rate was not negligible, and unplanned re-intervention was associated with a poor prognosis in resected hilar MBO. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Success of Intubation Rescue Techniques after Failed Direct Laryngoscopy in Adults: A Retrospective Comparative Analysis from the Multicenter Perioperative Outcomes Group.

PubMed

Aziz, Michael F; Brambrink, Ansgar M; Healy, David W; Willett, Amy Wen; Shanks, Amy; Tremper, Tyler; Jameson, Leslie; Ragheb, Jacqueline; Biggs, Daniel A; Paganelli, William C; Rao, Janavi; Epps, Jerry L; Colquhoun, Douglas A; Bakke, Patrick; Kheterpal, Sachin

2016-10-01

Multiple attempts at tracheal intubation are associated with mortality, and successful rescue requires a structured plan. However, there remains a paucity of data to guide the choice of intubation rescue technique after failed initial direct laryngoscopy. The authors studied a large perioperative database to determine success rates for commonly used intubation rescue techniques. Using a retrospective, observational, comparative design, the authors analyzed records from seven academic centers within the Multicenter Perioperative Outcomes Group between 2004 and 2013. The primary outcome was the comparative success rate for five commonly used techniques to achieve successful tracheal intubation after failed direct laryngoscopy: (1) video laryngoscopy, (2) flexible fiberoptic intubation, (3) supraglottic airway as part of an exchange technique, (4) optical stylet, and (5) lighted stylet. A total of 346,861 cases were identified that involved attempted tracheal intubation. A total of 1,009 anesthesia providers managed 1,427 cases of failed direct laryngoscopy followed by subsequent intubation attempts (n = 1,619) that employed one of the five studied intubation rescue techniques. The use of video laryngoscopy resulted in a significantly higher success rate (92%; 95% CI, 90 to 93) than other techniques: supraglottic airway conduit (78%; 95% CI, 68 to 86), flexible bronchoscopic intubation (78%; 95% CI, 71 to 83), lighted stylet (77%; 95% CI, 69 to 83), and optical stylet (67%; 95% CI, 35 to 88). Providers most frequently choose video laryngoscopy (predominantly GlideScope [Verathon, USA]) to rescue failed direct laryngoscopy (1,122/1,619; 69%), and its use has increased during the study period. Video laryngoscopy is associated with a high rescue intubation success rate and is more commonly used than other rescue techniques.

A machine learning tool for re-planning and adaptive RT: A multicenter cohort investigation.

PubMed

Guidi, G; Maffei, N; Meduri, B; D'Angelo, E; Mistretta, G M; Ceroni, P; Ciarmatori, A; Bernabei, A; Maggi, S; Cardinali, M; Morabito, V E; Rosica, F; Malara, S; Savini, A; Orlandi, G; D'Ugo, C; Bunkheila, F; Bono, M; Lappi, S; Blasi, C; Lohr, F; Costi, T

2016-12-01

To predict patients who would benefit from adaptive radiotherapy (ART) and re-planning intervention based on machine learning from anatomical and dosimetric variations in a retrospective dataset. 90 patients (pts) treated for head-neck cancer (H&N) formed a multicenter data-set. 41 H&N pts (45.6%) were considered for learning; 49 pts (54.4%) were used to test the tool. A homemade machine-learning classifier was developed to analyze volume and dose variations of parotid glands (PG). Using deformable image registration (DIR) and GPU, patients' conditions were analyzed automatically. Support Vector Machines (SVM) was used for time-series evaluation. "Inadequate" class identified patients that might benefit from replanning. Double-blind evaluation by two radiation oncologists (ROs) was carried out to validate day/week selected for re-planning by the classifier. The cohort was affected by PG mean reduction of 23.7±8.8%. During the first 3weeks, 86.7% cases show PG deformation aligned with predefined tolerance, thus not requiring re-planning. From 4th week, an increased number of pts would potentially benefit from re-planning: a mean of 58% of cases, with an inter-center variability of 8.3%, showed "inadequate" conditions. 11% of cases showed "bias" due to DIR and script failure; 6% showed "warning" output due to potential positioning issues. Comparing re-planning suggested by tool with recommended by ROs, the 4th week seems the most favorable time in 70% cases. SVM and decision-making tool was applied to overcome ART challenges. Pts would benefit from ART and ideal time for re-planning intervention was identified in this retrospective analysis. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Postoperative Outcomes in Vedolizumab-Treated Patients Undergoing Major Abdominal Operations for Inflammatory Bowel Disease: Retrospective Multicenter Cohort Study.

PubMed

Lightner, Amy L; Mathis, Kellie L; Tse, Chung Sang; Pemberton, John H; Shen, Bo; Kochlar, Gursimran; Singh, Amandeep; Dulai, Parambir S; Eisenstein, Samuel; Sandborn, William J; Parry, Lisa; Stringfield, Sarah; Hudesman, David; Remzi, Feza; Loftus, Edward V

2018-03-19

Vedolizumab is now widely available for the treatment of moderate to severe ulcerative colitis (UC) and Crohn's disease (CD). We sought to quantify the rates of postoperative complications with preoperative vedolizumab compared with anti-tumor necrosis factor (anti-TNF) therapy. A multicenter retrospective review of adult inflammatory bowel disease (IBD) patients who underwent an abdominal operation between May 20, 2014, and December 31, 2015, was performed. The study cohort was comprised of patients who had received vedolizumab within 12 weeks of their abdominal operation, and the control cohort was IBD patients who had received anti-TNF therapy. A total of 146 patients received vedolizumab within 12 weeks before an abdominal operation (64% female; n = 93; median age, 33 years; range, 15-74 years), and 289 patients received anti-TNF therapy (49% female; n = 142; median age, 36 years; range, 17-73 years). Vedolizumab-treated patients were younger (P = 0.015) and were more likely to have taken corticosteroids (P < 0.01) within the 12 weeks before surgery. Vedolizumab-treated patients had a significantly increased risk of any postoperative surgical site infection (SSI; P < 0.01), superficial SSI (P < 0.01), deep space SSI (P = 0.39), and mucocutaneous separation of the diverting stoma (P < 0.00) as compared with patients taking anti-TNF therapy. On multivariate analysis, after adjusting for body mass index, steroids at the time of operation, and institution, exposure to vedolizumab remained a significant predictor of postoperative SSI (P < 0.01). We observed that vedolizumab-treated patients were at significantly increased risk of postoperative SSIs after a major abdominal operation, as compared with anti-TNF-treated patients.

Efficacy of Sleeve Gastrectomy with Duodenal-Jejunal Bypass for the Treatment of Obese Severe Diabetes Patients in Japan: a Retrospective Multicenter Study.

PubMed

Naitoh, Takeshi; Kasama, Kazunori; Seki, Yosuke; Ohta, Masayuki; Oshiro, Takashi; Sasaki, Akira; Miyazaki, Yasuhiro; Yamaguchi, Tsuyoshi; Hayashi, Hideki; Imoto, Hirofumi; Tanaka, Naoki; Unno, Michiaki

2018-02-01

The incidence of obesity with type 2 diabetes (T2DM) is increasing in Japan. The main bariatric surgery procedures in Japan are laparoscopic sleeve gastrectomy (LSG) and LSG with duodenal-jejunal bypass (LSG/DJB) because of the high incidence of gastric cancer and difficulty exploring a remnant stomach after gastric bypass. However, few studies have compared the antidiabetic effect of LSG/DJB with LSG alone. The purpose of this study is to compare the antidiabetic effect of LSG/DJB with that of LSG alone in Japanese obese diabetic patients. This was a retrospective multicenter study including 298 cases: 177 and 121 LSG and LSG/DJB cases, respectively. We investigated the antidiabetic effect of these two procedures at 12 months after surgery. Univariate and multivariate analyses were done to evaluate the predictive factors of T2DM remission. The diabetes remission rate at 12 months after surgery was 80.8% for LSG and 86.0% for LSG/DJB. Insulin use and HbA1c ≤ 6.7% were significant predictive factors in multivariate analysis for all patients. In patients with ABCD score ≥ 6, the diabetes remission rate was 94.8% and there was no difference between procedures. Only duration of diabetes and insulin use were significant predictive factors both in univariate and multivariate analyses. However, in cases with ABCD score ≤ 5, the remission rate was 70.3% and procedure type was the most significant predictive factor for diabetes remission (odds ratio [OR] 5.140). Although both LSG and LSG/DJB have good antidiabetic effects in Japanese obese patients, LSG/DJB is more effective for patients with lower ABCD scores.

[Whole-body-CT in Severely Injured Children. Results of Retrospective, Multicenter Study with Patients from the TraumaRegsiter DGU®].

PubMed

Hilbert-Carius, P; Hofmann, G O; Lefering, R; Stuttmann, R; Bucher, M; Goebel, P; Gronwald, G H

2015-07-01

A fast and comprehensive diagnostic by means of whole-body CT has been shown to reduce mortality in the adult trauma population. Therefore whole-body CT seems to be the standard in adult trauma-patients. Due to the higher radiation exposure of whole-body CT the use of this diagnostic toll in pediatric trauma patients is still under debate. It is not yet clear if whole-body CT in children can increase the probability of survival. In a retrospective, multicenter study, we used the data recorded in the TraumaRegister DGU(®) to calculate the probability of survival according to the revised injury severity classification (RISC) and standardized mortality ratio (SMR). The SMR reflects the ratio of recorded to expected mortality. Included in the study were all children (1-15 years) and adults (16-50 years) with an Injury Severity Score (ISS)>9, who were directly admitted to the hospital from the scene of accident. We compared the groups of patients given whole-body CT or non-whole-body CT. Subgroup analysis was performed for children 1-9 years, children 10-15 years and adults. A total of 1,456 pediatric trauma patients (mean age 9.9 years) and 20,796 adults (mean age 32.7 years) were included in the study. In contrast to adult trauma patients, were the SMR in the whole-body CT group was significant lower; we observed no advantage for the whole-body CT in pediatric trauma patients. Due to the missing advantage of whole-body CT in the pediatric trauma population and the higher radiation exposure of whole-body CT a non-whole-body CT approach seems equivalent with a lower radiation exposure. © Georg Thieme Verlag KG Stuttgart · New York.

Monotherapy versus Combination Therapy against Nonbacteremic Carbapenem-resistant Gram-negative Infections: A Retrospective Observational Study.

PubMed

Ghafur, Abdul; Devarajan, Vidyalakshmi; Raja, T; Easow, Jose; Raja, M A; Sreenivas, Sankar; Ramakrishnan, Balasubramaniam; Raman, S G; Devaprasad, Dedeepiya; Venkatachalam, Balaji; Nimmagadda, Ramesh

2017-12-01

Superiority of colistin-carbapenem combination therapy (CCCT) over colistin monotherapy (CMT) against carbapenem-resistant Gram-negative bacterial (CRGNB) infections is not conclusively proven. The aim of the current study was to analyze the effectiveness of both strategies against CRGNB nonbacteremic infections. This was a retrospective observational cohort study. Case record analysis of patients who had CRGNB nonbacteremic infections identified over a period of 4 years (January 2012-December 2015) was done by medical record review at a tertiary care center in India. P < 0.05 was considered as significant. Multivariate analysis was performed using Cox regression. Out of 153 patients (pneumonia 115, urinary tract infection 17, complicated skin and soft-tissue infection 18, intra-abdominal infection 1, and meningitis 2), 92 patients received CCCT and 61 received CMT. Univariate analysis revealed higher Acute Physiology and Chronic Health Evaluation II (APACHE II) score, pneumonia as the diagnosis, and Klebsiella as the causative organism to be the risk factors for higher 28-day mortality ( P = 0.036, 0.006, 0.016, respectively). Combination therapy had no significant impact on mortality (odds ratio [OR] = 0.91, 95% confidence interval [CI] = 0.327-2.535, P = 0.857). Multivariate analysis revealed that higher APACHE II score and infection due to Klebsiella were found to be independent risk factors for higher mortality (OR = 3.16 and 4.9, 95% CI = 1.34-7.4 and 2.19-11.2, P = 0.008 and 0.0001, respectively). In our retrospective single-center series of CRGNB nonbacteremic infections, CCCT was not superior to CMT. Multicenter large observational studies or prospective randomized clinical trials are the need of the hour.

The Value of Serum CA125 in the Diagnosis of Borderline Tumors of the Ovary: A Subanalysis of the Prospective Multicenter ROBOT Study.

PubMed

Fotopoulou, Christina; Sehouli, Jalid; Ewald-Riegler, Nina; de Gregorio, Nikolaus; Reuss, Alexander; Richter, Rolf; Mahner, Sven; Kommoss, Friedrich; Schmalfeldt, Barbara; Fehm, Tanja; Hanker, Lars; Wimberger, Pauline; Canzler, Ulrich; Pfisterer, Jacobus; Kommoss, Stefan; Hauptmann, Steffen; du Bois, Andreas

2015-09-01

The value of the serum tumor marker CA125 in borderline tumors of the ovary (BOTs) is not well defined, with unclear benefit in both diagnosis and follow-up. The aim of the present project was to identify the predictive value of CA125 for stage and relapse. CA125 data were extracted from the ROBOT multicenter study of patients with BOT treated between 1998 and 2008 in 24 German centers. While patients' data were retrieved retrospectively from hospital records and clinical tumor registries, follow-up and independent central pathology review were performed prospectively. We identified 127 patients from the ROBOT database fulfilling the eligibility criterion of available CA125 at initial diagnosis. Eighty-three (65.3%) patients had increased CA125 levels (>35 U/L). Of the patients, 85.0% presented with serous and 13.4% with mucinous BOT histology, whereas 29.9% had stage I disease. Fifteen (11.8%) patients experienced a relapse. Multivariate analysis identified raised CA125, young age, and serous histology as independent predictors of peritoneal implants of any type at initial presentation. Raised CA125 at initial diagnosis was, however, not an independent predictor of future relapse. Elevated CA125 seems to be associated with the presence of peritoneal implants of any type at initial diagnosis of serous BOT, but failed to have any independent predictive value on future relapse. Prospective multicenter studies are warranted to evaluate CA125 measurements in the follow-up management of BOT.

Outcomes for patients with congenital hepatoblastoma.

PubMed

Trobaugh-Lotrario, Angela D; Chaiyachati, Barbara H; Meyers, Rebecka L; Häberle, Beate; Tomlinson, Gail E; Katzenstein, Howard M; Malogolowkin, Marcio H; von Schweinitz, Dietrich; Krailo, Mark; Feusner, James H

2013-11-01

Congenital hepatoblastoma, diagnosed in the first month of life, has been reported to have a poor prognosis; however, a comprehensive evaluation of this entity is lacking. We retrospectively reviewed two patients from the senior authors' personal series and 25 cases identified in the databases of several multicenter group studies (INT-0098, P9645, 881, P9346, HB 89, HB94, and HB 99). We compared this series with cases of congenital hepatoblastoma previously published in the literature. The 3-year survival in our case series was 86% (18/21) with a follow-up of 44-230 months (median 85.5 months). Presentation and treatment were not substantially different from hepatoblastoma cohorts unselected for age. Survival was comparable to the reported disease free survival for a similar cohort of hepatoblastoma patients unselected for age between 1986 and 2002 (82.5%) [von Schweinitz et al., Eur J Cancer 1997; 33:1243-1249]. The 2-year survival of cases reported in the literature was 0% (0/9) and 42% (10/24) for patients reported before and after 1990, respectively. Congenital hepatoblastoma does not appear to confer a worse prognosis. The improved survival of our current series of patients, collected from the past 20 years of German and American multicenter trials and personal series, suggests that the outcome of hepatoblastoma at this young age is much better than has been historically reported. More rigorous analysis should be conducted in future multicenter trials. It is possible that congenital hepatoblastoma should be treated like all other patients with hepatoblastoma provided that the child is stable enough to proceed with surgery and chemotherapy. Copyright © 2013 Wiley Periodicals, Inc.

Delaying Surgical Treatment of Penile Fracture Results in Poor Functional Outcomes: Results from a Large Retrospective Multicenter European Study.

PubMed

Bozzini, Giorgio; Albersen, Maarten; Otero, Javier Romero; Margreiter, Markus; Cruz, Eduard Garcia; Mueller, Alexander; Gratzke, Christian; Serefoglu, Ege Can; Salamanca, Juan Ignacio Martinez; Verze, Paolo

2018-01-01

Penile fracture is a rare clinical entity that represents a urologic emergency. It involves traumatic rupture of the tunica albuginea of the corpora cavernosa due to twisting or bending of the penile shaft during erection. To determine the differences in preoperative diagnostic evaluation patterns and outcomes of penile fracture patients to investigate the impact of surgical delay on functional outcomes. A retrospective analysis was performed using data obtained from 137 patients presenting with penile fracture at seven different European academic medical centers between 1996 and 2013. Age, imaging modalities used, timing of surgical intervention, length of tunica albuginea defect, and surgical technique were recorded. Postoperative erectile function outcomes were assessed with the International Index of Erectile Function (IIEF-5), and the presence of postoperative penile curvature was noted. The association between timing of surgical intervention and postoperative IIEF-5 results was evaluated with discriminant function analysis. The median age of the patients was 34.50 yr (interquartile range [IQR]: 28.0-46.5 yr). Of the 137 patients, 82 (59.85%) underwent penile Doppler ultrasound, and 5 patients (3.64%) were evaluated with magnetic resonance imaging. All patients were treated surgically, and the duration between emergency room admission and surgical intervention was 5.0h (IQR: 3.6-8.0h). The median length of tunica albuginea defect was 10mm (IQR: 8-20mm). Postoperative IIEF-5 scores were 21 (IQR: 12-23) and 23 (IQR: 15-24) at the first and third postoperative months, respectively. Discriminant function analysis revealed that if the surgical intervention was performed >8.23hours after emergency room admission, postoperative erectile function was significantly worse (p=0.0051 at first month and p=0.0057 at third month postoperatively). Our multicenter study showed that delaying surgical intervention results in significantly impaired erectile function. Surgical treatment must be planned as soon as possible to avoid postoperative erectile dysfunction. We looked at sexual outcomes following the repair of penile fracture in a large European population. We found that outcomes worsened if surgical repair was delayed. Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Carotid Artery Injury in Anterior Cervical Spine Surgery: Multicenter Cohort Study and Literature Review.

PubMed

Härtl, Roger; Alimi, Marjan; Abdelatif Boukebir, Mohamed; Berlin, Connor D; Navarro-Ramirez, Rodrigo; Arnold, Paul M; Fehlings, Michael G; Mroz, Thomas E; Riew, K Daniel

2017-04-01

Retrospective study and literature review. To provide more comprehensive data about carotid artery injury (CAI) or cerebrovascular accident (CVA) related to anterior cervical spine surgery. We conducted a retrospective, multicenter, case series study involving 21 high-volume surgical centers from the AOSpine North America Clinical Research Network. Medical records of 17 625 patients who went through cervical spine surgery (levels from C2 to C7) between January 1, 2005, and December 31, 2011, were analyzed. Also, we performed a literature review using Medline and PubMed databases. The following terms were used alone, and in combination, to search for relevant articles: cervical, spine, surgery, complication, iatrogenic, carotid artery, injury, cerebrovascular accident, CVA, and carotid stenosis. Among 17 625 patients that were analyzed, no cases were reported to experienced CAI or CVA after cervical spine surgery. Nevertheless, in our PubMed search we found 157 articles, but only 5 articles matched our study objective criteria; 2 cases were reported to present CAI and 3 cases presented CVA. CAI and CVA related to anterior cervical spine surgeries are extremely rare. We were not able to find neither in our retrospective study nor in our literature research a correlation between the type or length of anterior cervical spine procedure with CVA or CAI complications. However, surgeons should be aware of the possibility of vascular complications and minimize intraoperative direct vascular manipulations or retraction. Preoperative screening for underlying vascular pathology and risk factors is also important.

Esophageal Perforation Following Anterior Cervical Spine Surgery: Case Report and Review of the Literature

PubMed Central

Hershman, Stuart H.; Kunkle, William A.; Kelly, Michael P.; Buchowski, Jacob M.; Ray, Wilson Z.; Bumpass, David B.; Gum, Jeffrey L.; Peters, Colleen M.; Singhatanadgige, Weerasak; Kim, Jin Young; Smith, Zachary A.; Hsu, Wellington K.; Nassr, Ahmad; Currier, Bradford L.; Rahman, Ra’Kerry K.; Isaacs, Robert E.; Smith, Justin S.; Shaffrey, Christopher; Thompson, Sara E.; Wang, Jeffrey C.; Lord, Elizabeth L.; Buser, Zorica; Arnold, Paul M.; Fehlings, Michael G.; Mroz, Thomas E.

2017-01-01

Study Design: Multicenter retrospective case series and review of the literature. Objective: To determine the rate of esophageal perforations following anterior cervical spine surgery. Methods: As part of an AOSpine series on rare complications, a retrospective cohort study was conducted among 21 high-volume surgical centers to identify esophageal perforations following anterior cervical spine surgery. Staff at each center abstracted data from patients’ charts and created case report forms for each event identified. Case report forms were then sent to the AOSpine North America Clinical Research Network Methodological Core for data processing and analysis. Results: The records of 9591 patients who underwent anterior cervical spine surgery were reviewed. Two (0.02%) were found to have esophageal perforations following anterior cervical spine surgery. Both cases were detected and treated in the acute postoperative period. One patient was successfully treated with primary repair and debridement. One patient underwent multiple debridement attempts and expired. Conclusions: Esophageal perforation following anterior cervical spine surgery is a relatively rare occurrence. Prompt recognition and treatment of these injuries is critical to minimizing morbidity and mortality. PMID:28451488

Esophageal Perforation Following Anterior Cervical Spine Surgery: Case Report and Review of the Literature.

PubMed

Hershman, Stuart H; Kunkle, William A; Kelly, Michael P; Buchowski, Jacob M; Ray, Wilson Z; Bumpass, David B; Gum, Jeffrey L; Peters, Colleen M; Singhatanadgige, Weerasak; Kim, Jin Young; Smith, Zachary A; Hsu, Wellington K; Nassr, Ahmad; Currier, Bradford L; Rahman, Ra'Kerry K; Isaacs, Robert E; Smith, Justin S; Shaffrey, Christopher; Thompson, Sara E; Wang, Jeffrey C; Lord, Elizabeth L; Buser, Zorica; Arnold, Paul M; Fehlings, Michael G; Mroz, Thomas E; Riew, K Daniel

2017-04-01

Multicenter retrospective case series and review of the literature. To determine the rate of esophageal perforations following anterior cervical spine surgery. As part of an AOSpine series on rare complications, a retrospective cohort study was conducted among 21 high-volume surgical centers to identify esophageal perforations following anterior cervical spine surgery. Staff at each center abstracted data from patients' charts and created case report forms for each event identified. Case report forms were then sent to the AOSpine North America Clinical Research Network Methodological Core for data processing and analysis. The records of 9591 patients who underwent anterior cervical spine surgery were reviewed. Two (0.02%) were found to have esophageal perforations following anterior cervical spine surgery. Both cases were detected and treated in the acute postoperative period. One patient was successfully treated with primary repair and debridement. One patient underwent multiple debridement attempts and expired. Esophageal perforation following anterior cervical spine surgery is a relatively rare occurrence. Prompt recognition and treatment of these injuries is critical to minimizing morbidity and mortality.

Incidence of cervical lymph node metastasis and its association with outcomes in patients with adenoid cystic carcinoma. An international collaborative study

PubMed Central

Amit, Moran; Binenbaum, Yoav; Sharma, Kanika; Ramer, Naomi; Ramer, Ilana; Agbetoba, Abib; Glick, Joelle; Yang, Xinjie; Lei, Delin; Bjørndal, Kristine; Godballe, Christian; Mücke, Thomas; Wolff, Klaus-Dietrich; Fliss, Dan; Eckardt, André M.; Copelli, Chiara; Sesenna, Enrico; Palmer, Frank; Ganly, Ian; Patel, Snehal; Gil, Ziv

2016-01-01

Background The patterns of regional metastasis in adenoid cystic carcinoma (ACC) of the head and neck and its association with outcome is not established. Methods We conducted a retrospective multicentered multivariate analysis of 270 patients who underwent neck dissection. Results The incidence rate of neck metastases was 29%. The rate observed in the oral cavity is 37%, and in the major salivary glands is 19% (p = .001). The rate of occult nodal metastases was 17%. Overall 5-year survival rates were 44% in patients undergoing therapeutic neck dissections, and 65% and 73% among those undergoing elective neck dissections, with and without nodal metastases, respectively (p = .017). Multivariate analysis revealed that the primary site, nodal classification, and margin status were independent predictors of survival. Conclusion Our findings support the consideration of elective neck treatment in patients with ACC of the oral cavity. PMID:25060927

Comparative Effectiveness of DPP-4 Inhibitors Versus Sulfonylurea for the Treatment of Type 2 Diabetes in Routine Clinical Practice: A Retrospective Multicenter Real-World Study.

PubMed

Fadini, Gian Paolo; Bottigliengo, Daniele; D'Angelo, Federica; Cavalot, Franco; Bossi, Antonio Carlo; Zatti, Giancarlo; Baldi, Ileana; Avogaro, Angelo

2018-06-01

DPP-4 inhibitors (DPP4i) and sulfonylureas are popular second-line therapies for type 2 diabetes (T2D), but there is a paucity of real-world studies comparing their effectiveness in routine clinical practice. This was a multicenter retrospective study on diabetes outpatient clinics comparing the effectiveness of DPP4i versus gliclazide extended release. The primary endpoint was change from baseline in HbA1c. Secondary endpoints were changes in fasting plasma glucose, body weight, and systolic blood pressure. Automated software extracted data from the same clinical electronic chart system at all centers. Propensity score matching (PSM) was used to generate comparable cohorts to perform outcome analysis. We included data on 2410 patients starting DPP4i and 1590 patients starting gliclazide (mainly 30-60 mg/day). At baseline, the two groups differed in disease duration, body weight, blood pressure, HbA1c, fasting glucose, HDL cholesterol, triglycerides, liver enzymes, eGFR, prevalence of microangiopathy, and use of metformin. Among DPP4i molecules, no difference in glycemic effectiveness was detected. In matched cohorts (n = 1316/group), patients starting DPP4i, as compared with patients starting gliclazide, experienced greater reductions in HbA1c (- 0.6% versus - 0.4%; p < 0.001), fasting glucose (- 14.1 mg/dl versus - 8.8 mg/dl; p = 0.007), and body weight (- 0.4 kg versus - 0.1 kg; p = 0.006) after an average 6 months follow-up. DPP4i improved glucose control more than gliclazide, especially in patients who had failed with other glucose-lowering medications or were on basal insulin. This large retrospective real-world study shows that, in routine clinical practice, starting a DPP4i allows better glycemic control than starting low-dose gliclazide. The Italian Diabetes Society, with external support from AstraZeneca.

Luminal-like HER2-negative stage IA breast cancer: a multicenter retrospective study on long-term outcome with propensity score analysis

PubMed Central

De Angelis, Carmine; Di Maio, Massimo; Crispo, Anna; Giuliano, Mario; Schettini, Francesco; Bonotto, Marta; Gerratana, Lorenzo; Iacono, Donatella; Cinausero, Marika; Riccardi, Ferdinando; Ciancia, Giuseppe; De Laurentiis, Michelino; Puglisi, Fabio; De Placido, Sabino; Arpino, Grazia

2017-01-01

The benefit of adding chemotherapy (CT) to adjuvant hormone therapy (HT) in stage IA luminal-like HER2-negative breast cancer (BC) is unclear. We retrospectively evaluated predictive factors and clinical outcome of 1,222 patients from 4 oncologic centers. Three hundred and eighty patients received CT and HT (CT-cohort) and 842 received HT alone (HT-cohort). Disease-free survival (DFS) and overall survival (OS) were evaluated with univariate and multivariate analyses. We also applied the propensity score methodology. Compared with the HT-cohort, patients in the CT-cohort were more likely to be younger, have larger tumors of a higher histological grade that were Ki67-positive, and lower estrogen and progesterone receptor expression. At univariate analysis, a higher histological grade and Ki67 were significantly associated to a lower DFS. At multivariable analysis, only histological grade was predictive of DFS. The CT-cohort had a worse outcome than the HT-cohort in terms of DFS and OS, but differences disappeared when matched according to propensity score. In summary, patients with stage IA luminal-like BC had an excellent prognosis, however relapse and mortality were higher in the CT-cohort than in the HT-cohort. Longer use of adjuvant HT or other therapeutic strategies may be needed to improve outcome. PMID:29348868

Nationwide, Multicenter, Retrospective Study on High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yoshioka, Yasuo, E-mail: yoshioka@radonc.med.osaka-u.ac.jp; Kotsuma, Tadayuki; Komiya, Akira

Purpose: To present, analyze, and discuss results of a nationwide, multicenter, retrospective study on high-dose-rate brachytherapy (HDR-BT) as monotherapy for low-, intermediate-, and high-risk prostate cancer. Methods and Materials: From 1995 through 2013, 524 patients, 73 (14%) with low-risk, 207 (40%) with intermediate-risk, and 244 (47%) with high-risk prostate cancer, were treated with HDR-BT as monotherapy at 5 institutions in Japan. Dose fractionations were 27 Gy/2 fractions for 69 patients (13%), 45.5 Gy/7 fractions for 168 (32%), 49 Gy/7 fractions for 149 (28%), 54 Gy/9 fractions for 130 (25%), and others for 8 (2%). Of these patients, 156 (30%) did not receive androgen deprivationmore » therapy, and 202 patients (39%) did receive androgen deprivation therapy <1 year, 112 (21%) for 1-3 years, and 54 (10%) for >3 years. Median follow-up time was 5.9 years (range, 0.4-18.1 years), with a minimum of 2 years for surviving patients. Results: After 5 years, respective actuarial rates of no biochemical evidence of disease, overall survival, cause-specific survival, and metastasis-free survival for all patients were 92%, 97%, 99%, and 94%. For low/intermediate/high-risk patients, the 5-year no biochemical evidence of disease rates were 95%/94%/89%, the 5-year overall survival rates were 98%/98%/94%, the 5-year cause-specific survival rates were 98%/100%/98%, and the 5-year metastasis-free survival rates were 98%/95%/90%, respectively. The cumulative incidence of late grade 2 to 3 genitourinary toxicity at 5 years was 19%, and that of late grade 3 was 1%. The corresponding incidences of gastrointestinal toxicity were 3% and 0% (0.2%). No grade 4 or 5 of either type of toxicity was detected. Conclusions: The findings of this nationwide, multicenter, retrospective study demonstrate that HDR-BT as monotherapy was safe and effective for all patients with low-, intermediate-, and high-risk prostate cancer.« less

A Multicenter Analysis of Factors Associated With Apixaban-Related Bleeding in Hospitalized Patients With End-Stage Renal Disease on Hemodialysis.

PubMed

Steuber, Taylor D; Shiltz, Dane L; Cairns, Alex C; Ding, Qian; Binger, Katie J; Courtney, Julia R

2017-11-01

In 2014, the United States Food and Drug Administration approved a labeling change for apixaban to include recommendations for patients with severe renal impairment and patients with end-stage renal disease (ESRD) on hemodialysis (HD), though these recommendations are largely based on pharmacokinetic and pharmacodynamic data. Identify variables associated with bleeding events in hospitalized patients with ESRD on HD receiving apixaban. This retrospective, multicenter cohort study evaluated hospitalized patients with ESRD on HD receiving apixaban from January 1, 2013, through March 31, 2016. Correlational analysis and logistic regression were completed to identify factors associated with bleeding. A total of 114 adults were included in the analysis. The median length of stay (LOS) was 6.2 (interquartile range = 3.8-11.9) days and bleeding events occurred in a total of 17 patients (15%). A weak correlation was identified for higher cumulative apixaban exposure, increased number of HD sessions while receiving apixaban, and increased hospital LOS ( P < 0.05; correlation coefficient < 0.40). When controlling for confounders, logistic regression revealed that composite bleeding events were independently increased by continuation of outpatient apixaban (odds ratio = 13.07; 95% CI = 1.54-110.54; P = 0.018), increased total daily dose of apixaban (odds ratio = 1.72; 95% CI = 1.20 to 2.48; P = 0.003), and total HD sessions while receiving apixaban (odds ratio = 2.04; 95% CI = 1.06-3.92; P = 0.033). The association between these factors and increased bleeding should prompt concern for long-term anticoagulation with apixaban in patients with ESRD receiving chronic HD.

Characteristics and Risk Factors for Type 2 Endoleak in an East Asian Population From a Japanese Multicenter Database.

PubMed

Fujimura, Naoki; Obara, Hideaki; Matsubara, Kentaro; Watada, Susumu; Shibutani, Shintaro; Akiyoshi, Takurin; Harada, Hirohisa; Kitagawa, Yuko

2016-01-01

Clinically distinct differences exist between East Asian and Caucasian subjects, but data for type 2 endoleak (T2EL) are limited in the East Asian population. The aim of this study was to analyze the characteristics of East Asian T2EL using a Japanese multicenter database. Retrospective analysis of 832 endovascular aneurysm repairs performed from 2008 to 2014 were conducted. T2EL was observed in 234 cases (28.1%), and in 32 cases (3.8%) it led to sac expansion >5 mm caused by isolated T2EL (median follow-up, 35.6 months). On univariate and multivariate analysis, non-smoker status (odds ratio [OR], 2.216; P<0.001), Excluder stent graft (OR, 2.027; P<0.001), and T2EL at final angiogram (OR, 2.080; P<0.001) were risk factors for T2EL. On multivariate analysis for isolated T2EL with sac expansion, only non-smoker status remained (OR, 2.671; P<0.001). Other than T1EL, isolated T2EL was the most significant risk factor for sac expansion (OR, 18.486; P<0.001). Furthermore, out of 11 transarterial embolization procedures initiated, 4 led to rupture during follow-up. East Asian T2EL had a strong relationship with non-smoker status. Also, T2EL was a significant risk factor for sac expansion, which sometimes led to rupture even after intervention. Along with the high prevalence of T2EL observed, East Asian T2EL may not always be benign.

Perioperative hemoglobin area under the curve is an independent predictor of renal failure after cardiac surgery. Results from a Spanish multicenter retrospective cohort study

PubMed Central

Duque-Sosa, Paula; Iribarren, María Josefa; Rábago, Gregorio

2017-01-01

Perioperative anemia is an important risk factor for cardiac surgery-associated acute kidney injury (CSA-AKI). Nonetheless, the severity of the anemia and the time in the perioperative period in which the hemoglobin level should be considered as a risk factor is conflicting. The present study introduces the concept of perioperative hemoglobin area under the curve (pHb-AUC) as a surrogate marker of the evolution of perioperative hemoglobin concentration. Through a retrospective analysis of prospectively collected data, we assessed this new variable as a risk factor for the development of acute kidney injury after cardiac surgery in 966 adult patients who underwent cardiac surgery with cardiopulmonary bypass, at twenty-three academic hospitals in Spain. Exclusion criteria were patients on renal replacement therapy, who needed a reoperation because of bleeding and/or with missing perioperative hemoglobin or creatinine values. Using a multivariate regression analysis, we found that a pHb-AUC <19 g/dL was an independent risk factor for CSA-AKI even after adjustment for intraoperative red blood cell transfusion (OR 1.41, p <0.05). It was also associated with mortality (OR 2.48, p <0.01) and prolonged hospital length of stay (4.67 ± 0.99 days, p <0.001) PMID:28225801

Cubital tunnel syndrome: comparative results of a multicenter study of 4 surgical techniques with a mean follow-up of 92 months.

PubMed

Bacle, G; Marteau, E; Freslon, M; Desmoineaux, P; Saint-Cast, Y; Lancigu, R; Kerjean, Y; Vernet, E; Fournier, J; Corcia, P; Le Nen, D; Rabarin, F; Laulan, J

2014-06-01

Cubital tunnel syndrome is the second most frequent entrapment syndrome. Physiopathology is mixed, and treatment options are multiple, none having yet proved superior efficacy. The present retrospective multicenter study compared results and rates of complications and recurrence between the 4 main cubital tunnel syndrome treatments, to identify trends and optimize outcome. Patients presenting with primary clinical cubital tunnel syndrome diagnosed on electroneuromyography were included and operated on using 1 of the following 4 techniques: open or endoscopic in situ decompression, or subcutaneous or submuscular anterior transposition. Four specialized upper-limb surgery centers participated, each systematically performing 1 of the above procedures. Subjective and objective results and rates of complications and recurrence were compared at end of follow-up. Five hundred and two patients were included and 375 followed up for a mean 92 months (range, 9-144 months); 103 were lost to follow-up and 24 died. Whichever the procedure, more than 90% of patients were cured or showed improvement. There was a single case of scar pain at end of follow-up, managed by endoscopic decompression; there were no other long-term complications. None of the 4 techniques aggravated symptoms. There were 6 recurrences by end of follow-up: 1 associated with open in situ decompression and 5 with submuscular transposition. Surgery was effective in treating cubital tunnel syndrome. Submuscular anterior transposition was associated with recurrence. In contrast to literature reports, subcutaneous anterior transposition, which is a reliable and valid technique, was not associated with a higher complication rate than in situ decompression. Level IV. Multicenter retrospective. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Outcomes of Robot-assisted Partial Nephrectomy for Clinical T2 Renal Tumors: A Multicenter Analysis (ROSULA Collaborative Group).

PubMed

Bertolo, Riccardo; Autorino, Riccardo; Simone, Giuseppe; Derweesh, Ithaar; Garisto, Juan D; Minervini, Andrea; Eun, Daniel; Perdona, Sisto; Porter, James; Rha, Koon Ho; Mottrie, Alexander; White, Wesley M; Schips, Luigi; Yang, Bo; Jacobsohn, Kenneth; Uzzo, Robert G; Challacombe, Ben; Ferro, Matteo; Sulek, Jay; Capitanio, Umberto; Anele, Uzoma A; Tuderti, Gabriele; Costantini, Manuela; Ryan, Stephen; Bindayi, Ahmet; Mari, Andrea; Carini, Marco; Keehn, Aryeh; Quarto, Giuseppe; Liao, Michael; Chang, Kidon; Larcher, Alessandro; De Naeyer, Geert; De Cobelli, Ottavio; Berardinelli, Francesco; Zhang, Chao; Langenstroer, Peter; Kutikov, Alexander; Chen, David; De Luyk, Nicolo; Sundaram, Chandru P; Montorsi, Francesco; Stein, Robert J; Haber, Georges Pascal; Hampton, Lance J; Dasgupta, Prokar; Gallucci, Michele; Kaouk, Jihad; Porpiglia, Francesco

2018-05-18

While partial nephrectomy (PN) represents the standard surgical management for cT1 renal masses, its role for cT2 tumors is controversial. Robot-assisted PN (RAPN) is being increasingly implemented worldwide. To analyze perioperative, functional, and oncological outcomes of RAPN for cT2 tumors. Retrospective analysis of a large multicenter, multinational dataset of patients with nonmetastatic cT2 masses treated with robotic surgery (ROSULA: RObotic SUrgery for LArge renal mass). Robotic-assisted PN. Patients' demographics, lesion characteristics, perioperative variables, renal functional data, pathology, and oncological data were analyzed. Univariable and multivariable regression analyses assessed the relationships with the risk of intra-/postoperative complications, recurrence, and survival. A total of 298 patients were analyzed. Median tumor size was 7.6 (7-8.5) cm. Median RENAL score was 9 (8-10). Median ischemia time was 25 (20-32) min. Median estimated blood loss was 150 (100-300) ml. Sixteen patients had intraoperative complications (5.4%), whereas 66 (22%) had postoperative complications (5% were Clavien grade ≥3). Multivariable analysis revealed that a lower RENAL score (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.21-0.65, p=0.02) and pathological pT2 stage (OR 0.51, 95% CI 0.12-0.86, p=0.001) were protective against postoperative complications. A total of 243 lesions (82%) were malignant. Twenty patients (8%) had positive surgical margins. Ten deaths and 25 recurrences/metastases occurred at a median follow-up of 12 (5-35) mo. At univariable analysis, higher pT stage was predictive of a likelihood of recurrences/metastases (p=0.048). While there was a significant deterioration of renal function at discharge, this remained stable over time at 1-yr follow-up. The main limitation of this study is its retrospective design. RAPN in the setting of select cT2 renal masses can safely be performed with acceptable outcomes. Further studies are warranted to corroborate our findings and to better define the role of robotic nephron sparing for this challenging indication. This report shows that robotic surgery can be used for safe removal of a large renal tumor in a minimally invasive fashion, maximizing preservation of renal function, and without compromising cancer control. Published by Elsevier B.V.

The efficacy of hydroxychloroquine for obstetrical outcome in anti-phospholipid syndrome: Data from a European multicenter retrospective study.

PubMed

Mekinian, Arsène; Lazzaroni, Maria Grazia; Kuzenko, Anna; Alijotas-Reig, Jaume; Ruffatti, Amelia; Levy, Pierre; Canti, Valentina; Bremme, Katarina; Bezanahary, Holy; Bertero, Tiziana; Dhote, Robin; Maurier, Francois; Andreoli, Laura; Benbara, Amélie; Tigazin, Ahmed; Carbillon, Lionel; Nicaise-Roland, Pascale; Tincani, Angela; Fain, Olivier

2015-06-01

In European multicenter study, we aimed to describe the real-life hydroxychloroquine use in APS patients during pregnancy and determine its benefit in refractory obstetrical APS. We analyzed the outcome of pregnancies treated by hydroxychloroquine in patients with APS or asymptomatic antiphospholipid (aPL) antibodies carriers. Thirty patients with APS with 35 pregnancies treated by hydroxychloroquine were analyzed. Comparing the outcome of pregnancies treated by the addition of hydroxychloroquine to previous pregnancies under the conventional treatment, pregnancy losses decreased from 81% to 19% (p<0.05), without differences in the associated treatments. The univariate analysis showed that the previous intrauterine deaths and higher hydroxychloroquine amount (400mg per day) were the factors associated with pregnancy outcome. Considering 14 patients with previous refractory obstetrical APS (n=5 with obstetrical and thrombotic primary APS and n=9 with purely obstetrical APS), all with previous pregnancy losses under treatment (aspirin with LMWH in 11 cases and LMWH in 3 cases), the addition of hydroxychloroquine resulted in live born babies in 11/14 (78%) cases (p<0.05). Our study shows the benefit of hydroxychloroquine addition in patients with refractory obstetrical APS and raises the need of prospective studies to confirm our preliminary study. Copyright © 2015 Elsevier B.V. All rights reserved.

Multicenter validation study of a transplantation-specific cytogenetics grouping scheme for patients with myelodysplastic syndromes.

PubMed

Armand, P; Deeg, H J; Kim, H T; Lee, H; Armistead, P; de Lima, M; Gupta, V; Soiffer, R J

2010-05-01

Cytogenetics is an important prognostic factor for patients with myelodysplastic syndromes (MDS). However, existing cytogenetics grouping schemes are based on patients treated with supportive care, and may not be optimal for patients undergoing allo-SCT. We proposed earlier an SCT-specific cytogenetics grouping scheme for patients with MDS and AML arising from MDS, based on an analysis of patients transplanted at the Dana-Farber Cancer Institute/Brigham and Women's Hospital. Under this scheme, abnormalities of chromosome 7 and complex karyotype are considered adverse risk, whereas all others are considered standard risk. In this retrospective study, we validated this scheme on an independent multicenter cohort of 546 patients. Adverse cytogenetics was the strongest prognostic factor for outcome in this cohort. The 4-year relapse-free survival and OS were 42 and 46%, respectively, in the standard-risk group, vs 21 and 23% in the adverse group (P<0.0001 for both comparisons). This grouping scheme retained its prognostic significance irrespective of patient age, disease type, earlier leukemogenic therapy and conditioning intensity. Therapy-related disease was not associated with increased mortality in this cohort, after taking cytogenetics into account. We propose that this SCT-specific cytogenetics grouping scheme be used for patients with MDS or AML arising from MDS who are considering or undergoing SCT.

Multicenter retrospective analysis of cardiovascular risk factors affecting long-term outcome of de novo cardiac transplant recipients.

PubMed

Kobashigawa, Jon A; Starling, Randall C; Mehra, Mandeep R; Kormos, Robert L; Bhat, Geetha; Barr, Mark L; Sigouin, Chris S; Kolesar, June; Fitzsimmons, William

2006-09-01

Previous risk factor studies in cardiac transplant patients have analyzed pre-transplant risk factors as they relate to outcomes. This study is the first in-depth multicenter assessment of ongoing post-transplant risk factors in heart transplant patients and their impact on 5-year outcomes. We reviewed 280 heart transplant patients who survived > 1 year for the impact of post-transplant risk factors (hyperlipidemia, hypertension, diabetes, body mass index [BMI] and renal dysfunction: 8 to 18 possible measurements over 5 years) on outcomes, including death, cardiac allograft vasculopathy (CAV) and non-fatal major adverse cardiac events (NF-MACE). Upon multivariate Cox regression analysis, significant findings were high total-cholesterol for NF-MACE (relative risk [RR] = 4.34, confidence interval [CI] 1.35 to 13.98, p = 0.01), presence of diabetes for NF-MACE (RR = 3.96, CI 1.24 to 12.65, p = 0.02) and high serum creatinine for graft death (RR = 1.59, CI 1.35 to 1.87, p < 0.001). No covariates were found to be significant for CAV. Other significant risk factors by univariate Cox regression models with time-dependent covariates included BMI > or = 33 for graft death. Post-transplant risk factors of hypercholesterolemia and diabetes are associated with NF-MACE, whereas high serum creatinine and BMI > or = 33 are associated with graft death. Risk factor modification, including direct therapy to minimize risk factors, should be considered.

Clinical and Procedural Predictors of Outcomes From the Endovascular Treatment of Posterior Circulation Strokes.

PubMed

Mokin, Maxim; Sonig, Ashish; Sivakanthan, Sananthan; Ren, Zeguang; Elijovich, Lucas; Arthur, Adam; Goyal, Nitin; Kan, Peter; Duckworth, Edward; Veznedaroglu, Erol; Binning, Mandy J; Liebman, Kenneth M; Rao, Vikas; Turner, Raymond D; Turk, Aquilla S; Baxter, Blaise W; Dabus, Guilherme; Linfante, Italo; Snyder, Kenneth V; Levy, Elad I; Siddiqui, Adnan H

2016-03-01

Patients with posterior circulation strokes have been excluded from recent randomized endovascular stroke trials. We reviewed the recent multicenter experience with endovascular treatment of posterior circulation strokes to identify the clinical, radiographic, and procedural predictors of successful recanalization and good neurological outcomes. We performed a multicenter retrospective analysis of consecutive patients with posterior circulation strokes, who underwent thrombectomy with stent retrievers or primary aspiration thrombectomy (including A Direct Aspiration First Pass Technique [ADAPT] approach). We correlated clinical and radiographic outcomes with demographic, clinical, and technical characteristics. A total of 100 patients were included in the final analysis (mean age, 63.5±14.2 years; mean admission National Institutes of Health Stroke Scale score, 19.2±8.2). Favorable clinical outcome at 3 months (modified Rankin Scale score ≤2) was achieved in 35% of patients. Successful recanalization and shorter time from stroke onset to the start of the procedure were significant predictors of favorable clinical outcome at 90 days. Stent retriever and aspiration thrombectomy as primary treatment approaches showed comparable procedural and clinical outcomes. None of the baseline advanced imaging modalities (magnetic resonance imaging, computed tomographic perfusion, or computed tomography angiography assessment of collaterals) showed superiority in selecting patients for thrombectomy. Time to the start of the procedure is an important predictor of clinical success after thrombectomy in patients with posterior circulation strokes. Both stent retriever and aspiration thrombectomy as primary treatment approaches are effective in achieving successful recanalization. © 2016 American Heart Association, Inc.

Survival after Second and Subsequent Recurrences in Osteosarcoma: A Retrospective Multicenter Analysis.

PubMed

Tirtei, Elisa; Asaftei, Sebastian D; Manicone, Rosaria; Cesari, Marilena; Paioli, Anna; Rocca, Michele; Ferrari, Stefano; Fagioli, Franca

2017-05-01

Purpose Osteosarcoma (OS) is the most common primary bone tumor. Despite complete surgical removal and intensive chemotherapeutic treatment, 30%-35% of patients with OS have local or systemic recurrence. Some patients survive multiple recurrences, but overall survival after OS recurrence is poor. This analysis aims to describe and identify factors influencing post-relapse survival (PRS) after a second OS relapse. Methods This is a retrospective analysis of 60 patients with a second relapse of OS of the extremities in 2 Italian centers between 2003 and 2013. Results Treatment for first and subsequent relapses was planned according to institutional guidelines. After complete surgical remission (CSR) following the first recurrence, patients experienced a second OS relapse with a median disease-free interval (DFI) of 6 months. Lung disease was prevalent: 44 patients (76%) had pulmonary metastases. Survival after the second relapse was 22% at 5 years. Lung disease only correlated with better survival at 5 years (33.6%) compared with other sites of recurrence (5%; p = 0.008). Patients with a single pulmonary lesion had a better 5-year second PRS (42%; p = 0.02). Patients who achieved a second CSR had a 5-year second PRS of 33.4%. Chemotherapy (p<0.001) benefited patients without a third CSR. Conclusions This analysis confirms the importance of an aggressive, repeated surgical approach. Lung metastases only, the number of lesions, DFI and CSR influenced survival. It also confirms the importance of chemotherapy in patients in whom surgical treatment is not feasible.

Laparoscopic cholecystectomy for acute cholecystitis: are intended operative approach, timing and outcome affected by BMI? A multicenter retrospective study.

PubMed

Lauro, A; Vaccari, S; Cervellera, M; Casella, Giuseppina; D'Andrea, V; Di Matteo, F M; Panarese, A; Santoro, A; Cirocchi, R; Tonini, V

2018-01-01

Laparoscopy is the gold-standard for cholecystectomy after acute cholecystitis, but the issue is controversial in obese subjects. We reviewed 464 patients operated for acute cholecystitis (59 open and 405 laparoscopic) over the last five years at St Orsola University Hospital-Bologna and Umberto I University Hospital-Rome, comparing retrospectively: 1) BMI < 30 (397 patients) and BMI =/> 30 (67 patients) and moreover 2) BMI < 25 (207 patients) and BMI =/> 25 (257 patients). In the first comparison, obese patients showed higher cardiovascular co-morbidity (61.1% vs 44.5%, p=0.01), worse symptoms (Murphy's sign positive in 92.5% vs 80.8%, p=0.02; fever >38.5°C in 88.0% vs 76.0 %, p=0.02) and significant radiologic imaging (95.5% vs 85.1%, p=0.01) of acute cholecystitis. Laparoscopy was used in 83.6% of obese patients vs 87.9% without any difference, and operative time or conversion rate were similar. According to Tokyo Guidelines 2013, the number of patients who underwent surgery within 3 days or after 6 weeks was similar without statistical difference between the two groups. Hospital stay, morbidity and mortality were similar. Complications were seen in 25.4% of obese patients vs 15.9% (p= 0.03), mainly represented by wound infections. The second comparison did show no difference between two groups BMI =/>25 and BMI < 25. Our retrospective multicenter study showed no difference related to intended operative approach, timing and outcome in higher BMI versus lower BMI patients operated for acute cholecystitis.

A Large Multicenter Experience With Endoscopic Suturing for Management of Gastrointestinal Defects and Stent Anchorage in 122 Patients: A Retrospective Review.

PubMed

Sharaiha, Reem Z; Kumta, Nikhil A; DeFilippis, Ersilia M; Dimaio, Christopher J; Gonzalez, Susana; Gonda, Tamas; Rogart, Jason; Siddiqui, Ali; Berg, Paul S; Samuels, Paul; Miller, Larry; Khashab, Mouen A; Saxena, Payal; Gaidhane, Monica R; Tyberg, Amy; Teixeira, Julio; Widmer, Jessica; Kedia, Prashant; Loren, David; Kahaleh, Michel; Sethi, Amrita

2016-01-01

To describe a multicenter experience using an endoscopic suturing device for management of gastrointestinal (GI) defects and stent anchorage. Endoscopic closure of GI defects including perforations, fistulas, and anastomotic leaks as well as stent anchorage has improved with technological advances. An endoscopic suturing device (OverStitch; Apollo Endosurgery Inc.) has been used. Retrospective study of consecutive patients who underwent endoscopic suturing for management of GI defects and/or stent anchorage were enrolled between March 2012 and January 2014 at multiple academic medical centers. Data regarding demographic information and outcomes including long-term success were collected. One hundred and twenty-two patients (mean age, 52.6 y; 64.2% females) underwent endoscopic suturing at 8 centers for stent anchorage (n=47; 38.5%), fistulas (n=40; 32.7%), leaks (n=15; 12.3%), and perforations (n=20; 16.4%). A total of 44.2% underwent prior therapy and 97.5% achieved technical success. Immediate clinical success was achieved in 79.5%. Long-term clinical success was noted in 78.8% with mean follow-up of 68 days. Clinical success was 91.4% in stent anchorage, 93% in perforations, 80% in fistulas, but only 27% in anastomotic leak closure. Endoscopic suturing for management of GI defects and stent anchoring is safe and efficacious. Stent migration after stent anchoring was reduced compared with published data. Long-term success without further intervention was achieved in the majority of patients. The role of endoscopic suturing for repair of anastomotic leaks remains unclear given limited success in this retrospective study.

Carotid Artery Injury in Anterior Cervical Spine Surgery: Multicenter Cohort Study and Literature Review

PubMed Central

Alimi, Marjan; Abdelatif Boukebir, Mohamed; Berlin, Connor D.; Navarro-Ramirez, Rodrigo; Arnold, Paul M.; Fehlings, Michael G.; Mroz, Thomas E.; Riew, K. Daniel

2017-01-01

Study Design: Retrospective study and literature review. Objective: To provide more comprehensive data about carotid artery injury (CAI) or cerebrovascular accident (CVA) related to anterior cervical spine surgery. Methods: We conducted a retrospective, multicenter, case series study involving 21 high-volume surgical centers from the AOSpine North America Clinical Research Network. Medical records of 17 625 patients who went through cervical spine surgery (levels from C2 to C7) between January 1, 2005, and December 31, 2011, were analyzed. Also, we performed a literature review using Medline and PubMed databases. The following terms were used alone, and in combination, to search for relevant articles: cervical, spine, surgery, complication, iatrogenic, carotid artery, injury, cerebrovascular accident, CVA, and carotid stenosis. Results: Among 17 625 patients that were analyzed, no cases were reported to experienced CAI or CVA after cervical spine surgery. Nevertheless, in our PubMed search we found 157 articles, but only 5 articles matched our study objective criteria; 2 cases were reported to present CAI and 3 cases presented CVA. Conclusions: CAI and CVA related to anterior cervical spine surgeries are extremely rare. We were not able to find neither in our retrospective study nor in our literature research a correlation between the type or length of anterior cervical spine procedure with CVA or CAI complications. However, surgeons should be aware of the possibility of vascular complications and minimize intraoperative direct vascular manipulations or retraction. Preoperative screening for underlying vascular pathology and risk factors is also important. PMID:28451496

Assessment of the current D-dimer cutoff point in pulmonary embolism workup at a single institution: Retrospective study.

PubMed

Alhassan, S; Bihler, E; Patel, K; Lavudi, S; Young, M; Balaan, M

2018-06-06

The currently used D-dimer (DD) cutoff point is associated with a large number of negative CT-pulmonary angiographies (CTPA). We hypothesized presence of deficiency in the current cutoff and a need to look for a better DD threshold. We conducted a retrospective medical records analysis of all patients who had a CTPA as part of pulmonary embolism (PE) workup over a 1-year period. All emergency room (ER) patients who had DD assay checked prior to CTPA were included in the analysis. We assessed our institutional cutoff point and tried to test other presumptive DD thresholds retrospectively. At our institution 1591 CTPA were performed in 2014, with 1220 scans (77%) performed in the ER. DD test was ordered prior to CTPA imaging in 238 ER patients (19.5%) as part of the PE workup. PE was diagnosed in 14 cases (6%). The sensitivity and specificity of the currently used DD cutoff (0.5 mcg/mL) were found to be 100% and 13%, respectively. Shifting the cutoff value from 0.5 to 0.85 mcg/mL would result in a significant increase in the specificity from 13% to 51% while maintaining the same sensitivity of 100%. This would make theoretically 84 CTPA scans, corresponding to 35% of CTPA imaging, unnecessary because DD would be considered negative based on this presumptive threshold. Our results suggest a significant deficiency in the institutional DD cutoff point with the need to find a better threshold through a large multicenter prospective trial to minimize unnecessary CTPA scans and to improve patient safety.

Seizures in juvenile Huntington's disease: frequency and characterization in a multicenter cohort.

PubMed

Cloud, Leslie J; Rosenblatt, Adam; Margolis, Russel L; Ross, Christopher A; Pillai, Jagan A; Corey-Bloom, Jody; Tully, Hannah M; Bird, Thomas; Panegyres, Peter K; Nichter, Charles A; Higgins, Donald S; Helmers, Sandra L; Factor, Stewart A; Jones, Randi; Testa, Claudia M

2012-12-01

Little is known about the epilepsy that often occurs in the juvenile form of Huntington's disease (HD), but is absent from the adult-onset form. The primary aim of this study was to characterize the seizures in juvenile HD (JHD) subjects with regard to frequency, semiology, defining EEG characteristics, and response to antiepileptic agents. A multicenter, retrospective cohort was identified by database query and/or chart review. Data on age of HD onset, primary HD manifestations, number of CAG repeats, the presence or absence of seizures, seizure type(s), antiepileptic drugs used, subjects' response to antiepileptic drugs (AEDs), and EEG results were assembled, where available. Ninety subjects with genetically confirmed JHD were included. Seizures were present in 38% of subjects and were more likely to occur with younger ages of HD onset. Generalized tonic-clonic seizures were the most common seizure type, followed by tonic, myoclonic, and staring spells. Multiple seizure types commonly occurred within the same individual. Data on EEG findings and AED usage are presented. Seizure risk in JHD increases with younger age of HD onset. Our ability to draw firm conclusions about defining EEG characteristics and response to AEDs was limited by the retrospective nature of the study. Future prospective studies are required. Copyright © 2012 Movement Disorder Society.

Real-world outcome and healthcare costs of relapsed or refractory multiple myeloma: A retrospective analysis from the Chinese experience.

PubMed

Zhou, Xin; Xia, Jun; Mao, Jingjue; Cheng, Feng; Qian, Xifeng; Guo, Hongfeng

2016-06-01

Our aim was to retrospectively investigate the real-world outcome and healthcare costs associated with the treatment of patients with relapsed or refractory multiple myeloma (RRMM) in a Chinese single center. A retrospective study was conducted for 93 patients between January 2008 and December 2013 in a Chinese hematology department. Total monthly costs attributable to each cost component were described across all regimens and for bortezomib-based treatment regimens. Mean total cost per patient-month ($1139.85) varied depending on the sequence of therapy (range: mean $51.63-$6600.96). Drugs and hospital visit were the most and the least consumed resource (65.48% and 2.87%, respectively). Mean total monthly costs were $2071.96 (range: $679.73-$6600.96) and $551.14 (range: $51.63-$1698.59) for patients receiving bortezomib and patients not receiving bortezomib, respectively. Differences between the two groups were significant for drugs; drugs costs were higher for patients treated with bortezomib. Kaplan-Meier curves showed a longer overall survival (mean [median] 31.43 [25] vs. 21.93 [18] months) for patients treated with bortezomib. Real-world costs during treatment of RRMM varied greatly. Total costs during bortezomib-based regimens are significantly higher compared with non-bortezomib regimens. Further multi-center studies are needed to assess the cost-effectiveness of bortezomib for the treatment of RRMM in China.

Characterization of dermatitis after PD-1/PD-L1 inhibitor therapy and association with multiple oncologic outcomes: a retrospective case-control study.

PubMed

Min Lee, Charles Kyung; Li, Shufeng; Tran, Duy Cong; Zhu, Gefei Alex; Kim, Jinah; Kwong, Bernice Y; Chang, Anne Lynn S

2018-05-29

Cutaneous adverse events are common with Programmed Death (PD)-1/ PD-Ligand (L)1 inhibitors. However, the nature of the specific cutaneous adverse event of dermatitis has not been investigated across various PD-1/PD-L1 inhibitors. Oncologic outcomes potentially associated with dermatitis are not well characterized. (s): To assess the nature of dermatitis after PD-1/PD-L1 inhibitor exposure and oncologic outcomes associated with dermatitis. Retrospective, matched, case-control study conducted at a single academic center. The most common histologic patterns were lichenoid dermatitis (50%) and spongiotic dermatitis (40%). Overall tumor response rate was 65.0% for cases and 17.0% for controls (p=0.0007), odds ratio: 7.3 (95% CI 2.3-23.1). Progression Free Survival (PFS) and Overall Survival (OS) times were significantly longer for cases than controls by Kaplan-Meier analysis (p<0.0001 and 0.0203, respectively). Retrospective design and relatively small sample size precluded matching on all cancer types. Lichenoid and spongiotic dermatitis associated with PD-1/PD-L1 inhibitors could be a sign of robust immune response and improved oncologic outcomes. The predictive value of PD-1/PD-L1 related dermatitis on cancer outcomes awaits investigation through prospective multicenter studies for specific cancer types. Copyright © 2018. Published by Elsevier Inc.

Refractory obstetrical antiphospholipid syndrome: Features, treatment and outcome in a European multicenter retrospective study.

PubMed

Mekinian, Arsène; Alijotas-Reig, Jaume; Carrat, Fabrice; Costedoat-Chalumeau, Nathalie; Ruffatti, Amelia; Lazzaroni, Maria Grazia; Tabacco, Sara; Maina, Aldo; Masseau, Agathe; Morel, Nathalie; Esteve-Valverde, Enrique Esteve; Ferrer-Oliveras, Raquel; Andreoli, Laura; De Carolis, Sara; Josselin-Mahr, Laurence; Abisror, Noémie; Nicaise-Roland, Pascale; Tincani, Angela; Fain, Olivier

2017-07-01

To describe the consecutive pregnancy outcome and treatment in refractory obstetrical antiphospholipid syndrome (APS). Retrospective multicenter open-labelled study from December 2015 to June 2016. We analyzed the outcome of pregnancies in patients with obstetrical APS (Sydney criteria) and previous adverse obstetrical event despite low-dose aspirin and low-molecular weight heparin LMWH (LMWH) conventional treatment who experienced at least one subsequent pregnancy. Forty nine patients with median age 27years (23-32) were included from 8 European centers. Obstetrical APS was present in 71%, while 26% had obstetrical and thrombotic APS. Lupus anticoagulant was present in 76% and triple antiphospholipid antibody (APL) positivity in 45% of patients. Pregnancy loss was noted in 71% with a median age of gestation of 11 (8-21) weeks. The presence of APS non-criteria features (35% vs 17% in pregnancies without adverse obstetrical event; p=0.09), previous intrauterine death (65% vs 38%; p=0.06), of LA (90% vs 65%; p=0.05) were more frequent in pregnancies with adverse pregnancy outcome, whereas isolated recurrent miscarriage profile was more frequent in pregnancies without any adverse pregnancy outcome (15% vs 41%; p=0.04). In univariate analysis considering all pregnancies (index and subsequent ones), an history of previous intrauterine death was associated with pregnancy loss (odds-ratio 2.51 (95% CI 1.274.96); p=0.008), whereas previous history of prematurity related to APS (odds-ratio 0.13 95%CI 0.04 0.41, P=0.006), steroids use during the pregnancy (odds-ratio 0.30 95% CI 0.11-0.82, p=0.019) and anticardiolipids isolated profile (odds-ratio 0.51 95% CI 0.26-1.03, p=0.0588) were associated with favorable outcome. In multivariate analysis, only previous history of prematurity, steroids use and anticardiolipids isolated profiles were associated with live-birth pregnancy. The main features of refractory obstetrical APS were the high rates of LA and triple APL positivity. Steroids could be effective in this APS profile, but prospective studies are necessary. Copyright © 2017 Elsevier B.V. All rights reserved.

Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.

PubMed

Mantke, Rene; Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

2016-09-07

Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).

MiDas: Automatic Extraction of a Common Domain of Discourse in Sleep Medicine for Multi-center Data Integration

PubMed Central

Sahoo, Satya S.; Ogbuji, Chimezie; Luo, Lingyun; Dong, Xiao; Cui, Licong; Redline, Susan S.; Zhang, Guo-Qiang

2011-01-01

Clinical studies often use data dictionaries with controlled sets of terms to facilitate data collection, limited interoperability and sharing at a local site. Multi-center retrospective clinical studies require that these data dictionaries, originating from individual participating centers, be harmonized in preparation for the integration of the corresponding clinical research data. Domain ontologies are often used to facilitate multi-center data integration by modeling terms from data dictionaries in a logic-based language, but interoperability among domain ontologies (using automated techniques) is an unresolved issue. Although many upper-level reference ontologies have been proposed to address this challenge, our experience in integrating multi-center sleep medicine data highlights the need for an upper level ontology that models a common set of terms at multiple-levels of abstraction, which is not covered by the existing upper-level ontologies. We introduce a methodology underpinned by a Minimal Domain of Discourse (MiDas) algorithm to automatically extract a minimal common domain of discourse (upper-domain ontology) from an existing domain ontology. Using the Multi-Modality, Multi-Resource Environment for Physiological and Clinical Research (Physio-MIMI) multi-center project in sleep medicine as a use case, we demonstrate the use of MiDas in extracting a minimal domain of discourse for sleep medicine, from Physio-MIMI’s Sleep Domain Ontology (SDO). We then extend the resulting domain of discourse with terms from the data dictionary of the Sleep Heart and Health Study (SHHS) to validate MiDas. To illustrate the wider applicability of MiDas, we automatically extract the respective domains of discourse from 6 sample domain ontologies from the National Center for Biomedical Ontologies (NCBO) and the OBO Foundry. PMID:22195180

MiDas: automatic extraction of a common domain of discourse in sleep medicine for multi-center data integration.

PubMed

Sahoo, Satya S; Ogbuji, Chimezie; Luo, Lingyun; Dong, Xiao; Cui, Licong; Redline, Susan S; Zhang, Guo-Qiang

2011-01-01

Clinical studies often use data dictionaries with controlled sets of terms to facilitate data collection, limited interoperability and sharing at a local site. Multi-center retrospective clinical studies require that these data dictionaries, originating from individual participating centers, be harmonized in preparation for the integration of the corresponding clinical research data. Domain ontologies are often used to facilitate multi-center data integration by modeling terms from data dictionaries in a logic-based language, but interoperability among domain ontologies (using automated techniques) is an unresolved issue. Although many upper-level reference ontologies have been proposed to address this challenge, our experience in integrating multi-center sleep medicine data highlights the need for an upper level ontology that models a common set of terms at multiple-levels of abstraction, which is not covered by the existing upper-level ontologies. We introduce a methodology underpinned by a Minimal Domain of Discourse (MiDas) algorithm to automatically extract a minimal common domain of discourse (upper-domain ontology) from an existing domain ontology. Using the Multi-Modality, Multi-Resource Environment for Physiological and Clinical Research (Physio-MIMI) multi-center project in sleep medicine as a use case, we demonstrate the use of MiDas in extracting a minimal domain of discourse for sleep medicine, from Physio-MIMI's Sleep Domain Ontology (SDO). We then extend the resulting domain of discourse with terms from the data dictionary of the Sleep Heart and Health Study (SHHS) to validate MiDas. To illustrate the wider applicability of MiDas, we automatically extract the respective domains of discourse from 6 sample domain ontologies from the National Center for Biomedical Ontologies (NCBO) and the OBO Foundry.

Risk factor analysis of bloodstream infection in pediatric patients after hematopoietic stem cell transplantation.

PubMed

Sarashina, Takeo; Yoshida, Makoto; Iguchi, Akihiro; Okubo, Hitoshi; Toriumi, Naohisa; Suzuki, Daisuke; Sano, Hirozumi; Kobayashi, Ryoji

2013-01-01

Bloodstream infection (BSI) is a recognized cause of morbidity and mortality in children after hematopoietic stem cell transplantation (HSCT). However, there are limited reports on BSI after HSCT in pediatric patients in multiple centers. This study was a retrospective cohort analysis of consecutive patients who underwent allogeneic and autologous HSCT at the Department of Paediatrics, Hokkaido University Hospital, between 1988 and 2009; the Department of Paediatrics, Sapporo Hokuyu Hospital, between 2007 and 2009; and the Department of Paediatrics, Asahikawa Medical University, between 1989 and 2009. A total of 277 patients underwent HSCT during the study period. In this multicenter analysis, cases of BSI after HSCT were recorded in the early posttransplant period (within the first 100 d), and BSI was observed in 24 of 277 HSCT patients. Multivariate analysis showed that nonmalignant disease was an independent factor associated with BSI after HSCT (hazard ratio 6.3 for aplastic anemia or Wiskott-Aldrich syndrome patients; confidence interval, 1.4-12.8; P = 0.012). We conclude that aplastic anemia and Wiskott-Aldrich syndrome were the novel risk factors for BSI in pediatric patients after HSCT.

Mycophenolate mofetil as maintenance therapy for childhood-onset systemic lupus erythematosus patients with severe lupus nephritis.

PubMed

Kizawa, Toshitaka; Nozawa, Tomo; Kikuchi, Masako; Nagahama, Kiyotaka; Okudela, Koji; Miyamae, Takako; Imagawa, Tomoyuki; Nakamura, Tomoko; Mori, Masaaki; Yokota, Shumpei; Tsutsumi, Hiroyuki

2015-03-01

We evaluated histological changes occurring in renal biopsy specimens, between the time before initial induction therapy and after 12 months' maintenance therapy, as well as changes in laboratory parameters, SLE disease activity (SLEDAI), and dosage of corticosteroid (CS) in childhood-onset systemic lupus erythematosus (SLE) patients treated with mycophenolate mofetil (MMF). A retrospective analysis was performed on nine patients diagnosed with childhood-onset SLE and lupus nephritis. They were treated with pulsed mPSL and intravenous cyclophosphamide as induction therapy and MMF (500-1500 mg/day) plus CS as maintenance therapy. Renal biopsy was performed before the initial induction therapy and after 12 months' maintenance therapy. Pathological findings at second biopsy were improved in eight of nine patients (89%). The findings of SLEDAI, urinalysis, and blood tests also showed improvement. CS doses could be tapered satisfactorily. Adverse events were observed in two patients. No patients treated with MMF experienced any disease flares during maintenance therapy. MMF as maintenance therapy might be useful in that not only the histological findings of lupus nephritis were improved, but also CS doses could be beneficially tapered. Nonetheless, this is a retrospective report of only nine cases and further prospective multicenter studies are necessary.

Detection of Parathyroid Autofluorescence Using Near-Infrared Imaging: A Multicenter Analysis of Concordance Between Different Surgeons.

PubMed

Kahramangil, Bora; Dip, Fernando; Benmiloud, Fares; Falco, Jorge; de La Fuente, Martin; Verna, Silvina; Rosenthal, Raul; Berber, Eren

2018-04-01

Parathyroid glands (PGs) exhibit autofluorescence (AF) when excited by near-infrared laser. This multicenter study aims to analyze how this imaging could facilitate the detection of PGs during thyroidectomy and parathyroidectomy procedures. This was a retrospective Institutional Review Board-approved analysis of prospectively collected data at three centers. Near-infrared fluorescence imaging (NIFI) was used to detect AF from PGs during thyroidectomy and parathyroidectomy procedures. Logistic regression analysis was performed to assess the utility of NIFI to identify PGs and concordance at these centers. Overall, 210 patients underwent total thyroidectomy (n = 95), thyroid lobectomy (n = 41), and parathyroidectomy (n = 74) (n = 70 per center). Using NIFI, AF was detected from 98% of visually identified PGs. Upon initial exploration, 46% of PGs were not visible to the naked eye due to coverage by soft tissue, but AF from these glands could be detected by NIFI without any further dissection. Overall, a median of one PG per patient was detected by NIFI in this fashion before being identified visually (p = nonsignificant between centers). On logistic regression, smaller PGs were more likely to be missed visually, but localized by AF on NIFI (odds ratio with increasing size, 0.91; p = 0.02). In our experience, NIFI facilitated PG identification by detecting their AF, before conventional recognition by the surgeon, in 37-67% of the time. Despite the variability in this rate across centers, there was a concordance in detecting AF from 97 to 99% of the PGs using NIFI. We suggest the incorporation of AF on NIFI alongside conventional visual cues to aid identification of PGs during neck operations.

Lymphoma occurring during pregnancy: antenatal therapy, complications, and maternal survival in a multicenter analysis.

PubMed

Evens, Andrew M; Advani, Ranjana; Press, Oliver W; Lossos, Izidore S; Vose, Julie M; Hernandez-Ilizaliturri, Francisco J; Robinson, Barrett K; Otis, Stavroula; Nadav Dagan, Liat; Abdallah, Ramsey; Kroll-Desrosiers, Aimee; Yarber, Jessica L; Sandoval, Jose; Foyil, Kelley; Parker, Linda M; Gordon, Leo I; Blum, Kristie A; Flowers, Christopher R; Leonard, John P; Habermann, Thomas M; Bartlett, Nancy L

2013-11-10

Lymphoma is the fourth most frequent cancer in pregnancy; however, current clinical practice is based largely on small series and case reports. In a multicenter retrospective analysis, we examined treatment, complications, and outcomes for Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) occurring during pregnancy. Among 90 patients (NHL, n = 50; HL, n = 40), median age was 30 years (range, 18 to 44 years) and median diagnosis occurred at 24 weeks gestation. Of patients with NHL, 52% had advanced-stage versus 25% of patients with HL (P = .01). Pregnancy was terminated in six patients. Among the other 84 patients, 28 (33%) had therapy deferred to postpartum; these patients were diagnosed at a median 30 weeks gestation. This compared with 56 patients (67%) who received antenatal therapy with median lymphoma diagnosis at 21 weeks (P < .001); 89% of these patients received combination chemotherapy. The most common preterm complication was induction of labor (33%). Gestation went to full term in 56% of patients with delivery occurring at a median of 37 weeks. There were no differences in maternal complications, perinatal events, or median infant birth weight based on deferred versus antenatal therapy. At 41 months, 3-year progression-free survival (PFS) and overall survival (OS) for NHL were 53% and 82%, respectively, and 85% and 97%, respectively, for HL. On univariate analysis for NHL, radiotherapy predicted inferior PFS, and increased lactate dehydrogenase and poor Eastern Cooperative Oncology Group performance status (ECOG PS) portended worse OS. For HL patients, nulliparous status and "B" symptoms predicted inferior PFS. Standard (non-antimetabolite) combination chemotherapy administered past the first trimester, as early as 13 weeks gestation, was associated with few complications and expected maternal survival with lymphoma occurring during pregnancy.

Open versus robotic-assisted transabdominal preperitoneal (R-TAPP) inguinal hernia repair: a multicenter matched analysis of clinical outcomes.

PubMed

Gamagami, R; Dickens, E; Gonzalez, A; D'Amico, L; Richardson, C; Rabaza, J; Kolachalam, R

2018-04-26

To compare the perioperative outcomes of initial, consecutive robotic-assisted transabdominal preperitoneal (R-TAPP) inguinal hernia repair (IHR) cases with consecutive open cases completed by the same surgeons. Multicenter, retrospective, comparative study of perioperative results from open and robotic IHR using standard univariate and multivariate regression analyses for propensity score matched (1:1) cohorts. Seven general surgeons at six institutions contributed 602 consecutive open IHR and 652 consecutive R-TAPP IHR cases. Baseline patient characteristics in the unmatched groups were similar with the exception of previous abdominal surgery and all baseline characteristics were comparable in the matched cohorts. In matched analyses, postoperative complications prior to discharge were comparable. However, from post discharge through 30 days, fewer patients experienced complications in the R-TAPP group than in the open group [4.3% vs 7.7% (p = 0.047)]. The R-TAPP group had no reoperations post discharge through 30 days of follow-up compared with five patients (1.1%) in the open group (p = 0.062), respectively. Multivariate logistic regression analysis which demonstrated patient age > 65 years and the open approach were risk factors for complications within 30 days post discharge in the matched group [age > 65 years: odds ratio (OR) = 3.33 (95% CI 1.89, 5.87; p < 0.0001); open approach: OR = 1.89 (95% CI 1.05, 3.38; p = 0.031)]. In this matched analysis, R-TAPP provides similar postoperative complications prior to discharge and a lower rate of postoperative complications through 30 days compared to open repair. R-TAPP is a promising and reproducible approach, and may facilitate adoption of minimally invasive repairs of inguinal hernias.

Pre-transplantation risk factors to develop sclerotic chronic GvHD after allogeneic HSCT: a multicenter retrospective study from the Société Française de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC).

PubMed

Detrait, M Y; Morisset, S; Peffault de Latour, R; Yakoub-Agha, I; Crocchiolo, R; Tabrizi, R; Bay, J-O; Chevalier, P; Barraco, F; Raus, N; Vigouroux, S; Magro, L; Mohty, M; Milpied, N; Blaise, D; Socié, G; Michallet, M

2015-02-01

Sclerotic chronic GvHD (cGvHD) is one of the most severe complications after allo-hematopoietic stem cell transplantation (HSCT). Risk factors associated with this complication remain not very well defined. With the aim to define a pre-transplantation risk profile, we have conducted a French retrospective analysis in 705 consecutive patients between 2005 and 2010. Analyses to determine pre-transplantation risk factors included as variables: patient and donor age, kind of donor, HLA matching, ABO matching, sex-matching, diagnosis, stem cell source, gender, GvHD prophylaxis and antithymocyte globulin (ATG) in the conditioning regimen. The cumulative incidence of sclerotic cGvHD was 18% (95% CI, 16.6-19.6) 3 years after onset of cGvHD. In univariate analysis, we found a significantly lower number of sclerotic cGvHD form in patients transplanted from cord blood cells (P=0.0021), in patients with a one mismatched donor (P=0.041) and in patients who had received ATG in the conditioning regimen (P=0.002). In multivariate analysis, factors associated with an increased risk of sclerotic cGvHD were young patient age, multiple myeloma and PBSC as the stem cell source. ATG in conditioning regimen and cord blood unit as the stem cell source were associated with a lower risk.

Resective Epilepsy Surgery for Tuberous Sclerosis in Children: Determining Predictors of Seizure Outcomes in a Multicenter Retrospective Cohort Study.

PubMed

Fallah, Aria; Rodgers, Shaun D; Weil, Alexander G; Vadera, Sumeet; Mansouri, Alireza; Connolly, Mary B; Major, Philippe; Ma, Tracy; Devinsky, Orrin; Weiner, Howard L; Gonzalez-Martinez, Jorge A; Bingaman, William E; Najm, Imad; Gupta, Ajay; Ragheb, John; Bhatia, Sanjiv; Steinbok, Paul; Witiw, Christopher D; Widjaja, Elysa; Snead, O Carter; Rutka, James T

2015-10-01

There are no established variables that predict the success of curative resective epilepsy surgery in children with tuberous sclerosis complex (TSC). We performed a multicenter observational study to identify preoperative factors associated with seizure outcome in children with TSC undergoing resective epilepsy surgery. A retrospective chart review was performed in eligible children at New York Medical Center, Miami Children's Hospital, Cleveland Clinic Foundation, BC Children's Hospital, Hospital for Sick Children, and Sainte-Justine Hospital between January 2005 and December 2013. A time-to-event analysis was performed. The "event" was defined as seizures after resective epilepsy surgery. Seventy-four patients (41 male) were included. The median age of the patients at the time of surgery was 120 months (range, 3-216 months). The median time to seizure recurrence was 24.0 ± 12.7 months. Engel Class I outcome was achieved in 48 (65%) and 37 (50%) patients at 1- and 2-year follow-up, respectively. On univariate analyses, younger age at seizure onset (hazard ratio [HR]: 2.03, 95% confidence interval [CI]: 1.03-4.00, P = .04), larger size of predominant tuber (HR: 1.03, 95% CI: 0.99-1.06, P = .12), and resection larger than a tuberectomy (HR: 1.86, 95% CI: 0.92-3.74, P = .084) were associated with a longer duration of seizure freedom. In multivariate analyses, resection larger than a tuberectomy (HR: 2.90, 95% CI: 1.17-7.18, P = .022) was independently associated with a longer duration of seizure freedom. In this large consecutive cohort of children with TSC and medically intractable epilepsy, a greater extent of resection (more than just the tuber) is associated with a greater probability of seizure freedom. This suggests that the epileptogenic zone may include the cortex surrounding the presumed offending tuber.

Association of day 4 cumulative fluid balance with mortality in critically ill patients with influenza: A multicenter retrospective cohort study in Taiwan.

PubMed

Chao, Wen-Cheng; Tseng, Chien-Hua; Chien, Ying-Chun; Sheu, Chau-Chyun; Tsai, Ming-Ju; Fang, Wen-Feng; Chen, Yu-Mu; Kao, Kuo-Chin; Hu, Han-Chung; Perng, Wann-Cherng; Yang, Kuang-Yao; Chen, Wei-Chih; Liang, Shinn-Jye; Wu, Chieh-Liang; Wang, Hao-Chien; Chan, Ming-Cheng

2018-01-01

Fluid balance is a fundamental management of patients with sepsis, and this study aimed to investigate the impact of cumulative fluid balance on critically ill patients with influenza admitted to an intensive care unit (ICU). This multicenter retrospective cohort study was conducted by the Taiwan Severe Influenza Research Consortium (TSIRC) which includes eight medical centers. Patients with virology-proven influenza infection admitted to ICUs between October 2015 and March 2016 were included for analysis. A total of 296 patients were enrolled (mean age: 61.4±15.6 years; 62.8% men), and 92.2% (273/296) of them required mechanical ventilation. In the survivors, the daily fluid balance was positive from day 1 to day 3, and then gradually became negative from day 4 to day 7, whereas daily fluid balance was continuously positive in the non-survivors. Using the cumulative fluid balance from day 1-4 as a cut-off point, we found that a negative cumulative day 1-4 fluid balance was associated with a lower 30-day mortality rate (log-rank test, P = 0.003). To evaluate the impact of shock on this association, we divided the patients into shock and non-shock groups. The positive correlation between negative day 1-4 fluid balance and mortality was significant in the non-shock group (log-rank test, P = 0.008), but not in the shock group (log-rank test, P = 0.396). In a multivariate Cox proportional hazard regression model adjusted for age, sex, cerebrovascular disease, and PaO2/FiO2, day 1-4 fluid balance was independently associated with a higher 30-day mortality rate (aHR 1.088, 95% CI: 1.007-1.174). A negative day 1-4 cumulative fluid balance was associated with a lower mortality rate in critically ill patients with influenza. Our findings indicate the critical role of conservative fluid strategy in the management of patients with complicated influenza.

Medical expenditure for esophageal cancer in China: a 10-year multicenter retrospective survey (2002-2011).

PubMed

Guo, Lan-Wei; Huang, Hui-Yao; Shi, Ju-Fang; Lv, Li-Hong; Bai, Ya-Na; Mao, A-Yan; Liao, Xian-Zhen; Liu, Guo-Xiang; Ren, Jian-Song; Sun, Xiao-Jie; Zhu, Xin-Yu; Zhou, Jin-Yi; Gong, Ji-Yong; Zhou, Qi; Zhu, Lin; Liu, Yu-Qin; Song, Bing-Bing; Du, Ling-Bin; Xing, Xiao-Jing; Lou, Pei-An; Sun, Xiao-Hua; Qi, Xiao; Wu, Shou-Ling; Cao, Rong; Lan, Li; Ren, Ying; Zhang, Kai; He, Jie; Zhang, Jian-Gong; Dai, Min

2017-09-07

Esophageal cancer is associated with substantial disease burden in China, and data on the economic burden are fundamental for setting priorities in cancer interventions. The medical expenditure for the diagnosis and treatment of esophageal cancer in China has not been fully quantified. This study aimed to examine the medical expenditure of Chinese patients with esophageal cancer and the associated trends. From 2012 to 2014, a hospital-based multicenter retrospective survey was conducted in 37 hospitals in 13 provinces/municipalities across China as a part of the Cancer Screening Program of Urban China. For each esophageal cancer patient diagnosed between 2002 and 2011, clinical information and expense data were extracted by using structured questionnaires. All expense data were reported in Chinese Yuan (CNY; 1 CNY = 0.155 USD) based on the 2011 value and inflated using the year-specific health care consumer price index for China. A total of 14,967 esophageal cancer patients were included in the analysis. It was estimated that the overall average expenditure per patient was 38,666 CNY, and an average annual increase of 6.27% was observed from 2002 (25,111 CNY) to 2011 (46,124 CNY). The average expenditures were 34,460 CNY for stage I, 39,302 CNY for stage II, 40,353 CNY for stage III, and 37,432 CNY for stage IV diseases (P < 0.01). The expenditure also differed by the therapy type, which was 38,492 CNY for surgery, 27,933 CNY for radiotherapy, and 27,805 CNY for chemotherapy (P < 0.05). Drugs contributed to 45.02% of the overall expenditure. These conservative estimates suggested that medical expenditures for esophageal cancer in China substantially increased in the last 10 years, treatment for early-stage esophageal cancer costs less than that for advanced cases, and spending on drugs continued to account for a considerable proportion of the overall expenditure.

A retrospective analysis of the clinical efficacies of Q-switched Alexandrite and Q-switched Nd:YAG lasers in the treatment of nevus of Ota in Korean patients.

PubMed

Choi, Jae Eun; Lee, Joo Bong; Park, Ki Beom; Kim, Bang Soon; Yeo, Un-Cheol; Huh, Chang Hun; Kim, Jie Hoon; Kye, Young Chul

2015-06-01

While the Q-switched Alexandrite laser (QSAL) and the Q-switched neodymium: yttrium-aluminum-garnet (QSNY) laser have been widely used in treating nevus of Ota, few studies compared them. To compare the efficacies of the QSAL and the QSNY laser in the treatment of nevus of Ota in Korean patients. A retrospective multicenter study was conducted in 76 patients with nevus of Ota. Thirty-one patients were treated with a QSAL (5.5-8.0 J/cm(2), 4-mm spot size) and 45 patients were treated with QSNY laser (6.0-12.0 J/cm(2), 2-mm spot size). Treatment outcomes were categorized into five grades and the results were compared with the relevant variables taken into account using multivariate logistic regression analysis. QSAL treatment was more likely to achieve a better response compared with that with QSNY laser treatment. The odds ratio of achieving an excellent response, compared with the odds ratio of having a poor response, was 12.213-times more likely when a QSAL was used than when a QSNY laser was used (p = 0.026). The QSAL tends to be more efficient than the QSNY laser in the treatment of nevus of Ota in Korean patients. Further controlled, prospective comparison studies are needed.

Multicenter evaluation of efficacy and safety of low-dose versus high-dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D+/R+) renal transplant recipients.

PubMed

Heldenbrand, Seth; Li, Chenghui; Cross, Rosemary P; DePiero, Kelly A; Dick, Travis B; Ferguson, Kara; Kim, Miae; Newkirk, Erin; Park, Jeong M; Sudaria-Kerr, Janice; Tichy, Eric M; Ueda, Kimi R; Weng, Renee; Wisniewski, Jesse; Gabardi, Steven

2016-12-01

The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediate-risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900 mg/day for 3 months. This study is the first head-to-head analysis, to our knowledge, comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs 900 mg/day for 3 months in D+/R+ RTR. A multicenter, retrospective analysis evaluated 478 adult RTR between January 2008 and October 2011. Study participants received VGCV 450 mg/day (Group 1; n=398) or 900 mg/day (Group 2; n=89)×3 months for CMV prophylaxis. All VGCV was adjusted for renal function. All groups included in this study received study-approved induction and maintenance immunosuppression regimens. The primary endpoint was incidence of CMV disease at 12 months. The rates of graft loss, patient survival, T-cell and/or antibody-mediated rejection, hematological adverse events, opportunistic infections, and early VGCV discontinuation were evaluated. Patient demographics were comparable, but had significant differences in ethnicity and donor type between the groups. The occurrence of CMV disease at 12 months was similar between the groups (3.5% vs 3.4%; P=1.000). Log-rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939). © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Common Strategy for Adult and Pediatric Medulloblastoma: A Multicenter Series of 253 Adults

DOE Office of Scientific and Technical Information (OSTI.GOV)

Padovani, Laetitia; Sunyach, Marie-Pierre; Perol, David

2007-06-01

Purpose: To assess prognostic factors for adults with medulloblastoma in a multicenter, retrospective study. Methods and Materials: Data were collected by file review or mail inquiry for 253 adults treated between 1975 to 2004. Radiologists or surgeons assessed disease characteristics, such as volume and extension. Patients were classified as having either high- or standard-risk disease. Prognostic factors were analyzed. Results: Median patient age was 29 years. Median follow-up was 7 years. Radiotherapy was delivered in 246 patients and radiochemotherapy in 142. Seventy-four patients relapsed. Respective 5- and 10-year overall survival rates were 72% and 55%. Univariate analysis showed that survivalmore » significantly correlated with metastasis, postsurgical performance status, brainstem involvement, involvement of the floor of the fourth ventricle (V4), and radiation dose to the spine and to the posterior cerebral fossa (PCF). By multivariate analysis, brainstem, V4 involvement, and dose to the PCF were negative prognostic factors. In the standard-risk subgroup there was no overall survival difference between patients treated with axial doses of {>=}34 Gy and patients treated with craniospinal doses <34 Gy plus chemotherapy. Conclusion: We report the largest series of medulloblastoma in adults. Prognostic factors were similar to those observed in children. Results suggest that patients with standard-risk disease could be treated with radiochemotherapy, reducing doses to the craniospinal area, maintaining at least 50 Gy to the PCF. The role of chemotherapy for this group is still unclear. A randomized study should be performed to confirm these results, but because frequency is very low, such a study would be difficult.« less

Brentuximab vedotin for relapsed or refractory CD30+ Hodgkin lymphoma: a multicenter analysis from Asia.

PubMed

Yang, Qing-Ming; Hong, Jung Yong; Ko, Young Hyeh; Lin, Shek-Ying; Au, Wing-Yan; Choi, Moon Ki; Park, Silvia; Kim, Seok Jin; Kim, Won Seog

2014-01-01

Brentuximab vedotin (SGN-35), an anti-cluster of differentiation (CD)-30 antibody conjugated to the anti-tubulin agent monomethyl auristatin E, has demonstrated promising efficacy and tolerability in relapsed and heavily treated Hodgkin lymphoma (HL). In this study, we report the Asian experience with brentuximab vedotin in patients with relapsed or refractory CD30-positive (CD30+) HL. This is an observational, multicenter, retrospective study. Between October 2011 and June 2013, a total of 22 patients were treated with brentuximab vedotin under a named patient program in Asia. Patients received a 30 min infusion of brentuximab vedotin at a dose of 1.8 mg/kg of body weight every 3 weeks. Four patients (18.2%) showed a complete response, and the overall response rate was 72.7%. The median duration of response was 4.4 months (range 1.0-17.4). The median progression-free survival was 5.7 months, and the median overall survival has not yet been reached. The 1-year expected survival rate was 67.2%. The most common grade 3/4 adverse events were neutropenia (n=7; 31.8%). No patients experienced grade 3/4 sensory neuropathy. These results confirm that brentuximab vedotin as a single agent is also effective and well tolerated when used in Asian patients with relapsed and refractory CD30+ HL.

Initial multicenter technical experience with the Apollo device for minimally invasive intracerebral hematoma evacuation.

PubMed

Spiotta, Alejandro M; Fiorella, David; Vargas, Jan; Khalessi, Alexander; Hoit, Dan; Arthur, Adam; Lena, Jonathan; Turk, Aquilla S; Chaudry, M Imran; Gutman, Frederick; Davis, Raphael; Chesler, David A; Turner, Raymond D

2015-06-01

No conventional surgical intervention has been shown to improve outcomes for patients with spontaneous intracerebral hemorrhage (ICH) compared with medical management. We report the initial multicenter experience with a novel technique for the minimally invasive evacuation of ICH using the Penumbra Apollo system (Penumbra Inc, Alameda, California). Institutional databases were queried to perform a retrospective analysis of all patients who underwent ICH evacuation with the Apollo system from May 2014 to September 2014 at 4 centers (Medical University of South Carolina, Stony Brook University, University of California at San Diego, and Semmes-Murphy Clinic). Cases were performed either in the neurointerventional suite, operating room, or in a hybrid operating room/angiography suite. Twenty-nine patients (15 female; mean age, 62 ± 12.6 years) underwent the minimally invasive evacuation of ICH. Six of these parenchymal hemorrhages had an additional intraventricular hemorrhage component. The mean volume of ICH was 45.4 ± 30.8 mL, which decreased to 21.8 ± 23.6 mL after evacuation (mean, 54.1 ± 39.1% reduction; P < .001). Two complications directly attributed to the evacuation attempt were encountered (6.9%). The mortality rate was 13.8% (n = 4). Minimally invasive evacuation of ICH and intraventricular hemorrhage can be achieved with the Apollo system. Future work will be required to determine which subset of patients are most likely to benefit from this promising technology.

Temporal trends in patient characteristics and survival of intensive care admissions with sepsis: a multicenter analysis*.

PubMed

Dreiher, Jacob; Almog, Yaniv; Sprung, Charles L; Codish, Shlomi; Klein, Moti; Einav, Sharon; Bar-Lavie, Yaron; Singer, Pierre P; Nimrod, Adi; Sachs, Jeffrey; Talmor, Daniel; Friger, Michael; Greenberg, Dan; Olsfanger, David; Hersch, Moshe; Novack, Victor

2012-03-01

To estimate in-hospital, 1-yr, and long-term mortality and to assess time trends in incidence and outcomes of sepsis admissions in the intensive care unit. A population-based, multicenter, retrospective cohort study. Patients hospitalized with sepsis in the intensive care unit in seven general hospitals in Israel during 2002-2008. None. Survival data were collected and analyzed according to demographic and background clinical characteristics, as well as features of the sepsis episode, using Kaplan-Meier approach for long-term survival. A total of 5,155 patients were included in the cohort (median age: 70, 56.3% males; median Charlson comorbidity index: 4). The mean number of intensive care unit admissions per month increased over time, while no change in in-hospital mortality was observed. The proportion of patients surviving to hospital discharge was 43.9%. The 1-, 2-, 5-, and 8-yr survival rates were 33.0%, 29.8%, 23.3%, and 19.8%, respectively. Mortality was higher in older patients, patients with a higher Charlson comorbidity index, and those with multiorgan failure, and similar in males and females. One-year age-standardized mortality ratio was 21-fold higher than expected, based on the general population rates. Mortality following intensive care unit sepsis admission remains high and is correlated with underlying patients' characteristics, including age, comorbidities, and the number of failing organ systems.

A retrospective study on the efficacy and safety of intraveinous immunoglobulin (Tegeline®) in patients with chronic inflammatory demyelinating polyneuropathy.

PubMed

Robert, Florence; Edan, Gilles; Nicolas, Guillaume; Pouget, Jean; Vial, Christophe; Antoine, Jean-Christophe; Puget, Sophie

2015-01-01

To assess the efficacy and safety of intraveinous immunoglobulin (IV Ig) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) at 4, 7 and 12months. A national multicenter retrospective study was conducted by LFB Biotehcnologies in patients with CIDP who had received at least one cycle of a 5% polyvalent IV Ig, Tegeline(®), from LFB biomédicaments between 1995 and 2004. The primary endpoint was the efficacy of IV Ig at 4 months, which was defined as the responder rate based on the modified Rankin scale. Several secondary endpoints were assessed: safety and efficacy (i.e., responders according to the investigators' overall assessment of the patients' status) at 4, 7 and 12 months. The analysis was performed at 7 months only (due to missing data for 12 months and few patients). A total of 26 patients were included who had received between 1 and 6 cycles of IV Ig (mean 3±2) with a median follow-up of 9.9 months. The responder rate at 4 months based on the modified Rankin scale was 52% (95% CI 0.313-0.722), whereas the responder rate with placebo reported in the literature (meta-analysis including results from van Schaik and an ICE study) is 18% (P<0.001). Responder patients at 4 months were still responders at 7 months. The overall safety of IV Ig was good, with adverse events of mild to moderate severity, which resolved without sequelae and were expected adverse events of IV Ig. This retrospective study confirmed both the efficacy of IV Ig at 4 months in the treatment of chronic inflammatory demyelinating polyneuropathy and the favorable safety profile of the product. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Low-grade Glioma Surgery in Intraoperative Magnetic Resonance Imaging: Results of a Multicenter Retrospective Assessment of the German Study Group for Intraoperative Magnetic Resonance Imaging.

PubMed

Coburger, Jan; Merkel, Andreas; Scherer, Moritz; Schwartz, Felix; Gessler, Florian; Roder, Constantin; Pala, Andrej; König, Ralph; Bullinger, Lars; Nagel, Gabriele; Jungk, Christine; Bisdas, Sotirios; Nabavi, Arya; Ganslandt, Oliver; Seifert, Volker; Tatagiba, Marcos; Senft, Christian; Mehdorn, Maximilian; Unterberg, Andreas W; Rössler, Karl; Wirtz, Christian Rainer

2016-06-01

The ideal treatment strategy for low-grade gliomas (LGGs) is a controversial topic. Additionally, only smaller single-center series dealing with the concept of intraoperative magnetic resonance imaging (iMRI) have been published. To investigate determinants for patient outcome and progression-free-survival (PFS) after iMRI-guided surgery for LGGs in a multicenter retrospective study initiated by the German Study Group for Intraoperative Magnetic Resonance Imaging. A retrospective consecutive assessment of patients treated for LGGs (World Health Organization grade II) with iMRI-guided resection at 6 neurosurgical centers was performed. Eloquent location, extent of resection, first-line adjuvant treatment, neurophysiological monitoring, awake brain surgery, intraoperative ultrasound, and field-strength of iMRI were analyzed, as well as progression-free survival (PFS), new permanent neurological deficits, and complications. Multivariate binary logistic and Cox regression models were calculated to evaluate determinants of PFS, gross total resection (GTR), and adjuvant treatment. A total of 288 patients met the inclusion criteria. On multivariate analysis, GTR significantly increased PFS (hazard ratio, 0.44; P < .01), whereas "failed" GTR did not differ significantly from intended subtotal-resection. Combined radiochemotherapy as adjuvant therapy was a negative prognostic factor (hazard ratio: 2.84, P < .01). Field strength of iMRI was not associated with PFS. In the binary logistic regression model, use of high-field iMRI (odds ratio: 0.51, P < .01) was positively and eloquent location (odds ratio: 1.99, P < .01) was negatively associated with GTR. GTR was not associated with increased rates of new permanent neurological deficits. GTR was an independent positive prognostic factor for PFS in LGG surgery. Patients with accidentally left tumor remnants showed a similar prognosis compared with patients harboring only partially resectable tumors. Use of high-field iMRI was significantly associated with GTR. However, the field strength of iMRI did not affect PFS. EoR, extent of resectionFLAIR, fluid-attenuated inversion recoveryGTR, gross total resectionIDH1, isocitrate dehydrogenase 1iMRI, intraoperative magnetic resonance imagingLGG, low-grade gliomaMGMT, methylguanine-deoxyribonucleic acid methyltransferasenPND, new permanent neurological deficitOS, overall survivalPFS, progression-free survivalSTR, subtotal resectionWHO, World Health Organization.

Epidemiology of infective endocarditis in Tunisia: a 10-year multicenter retrospective study.

PubMed

Letaief, Amel; Boughzala, Essia; Kaabia, Naoufel; Ernez, Samia; Abid, Fekria; Ben Chaabane, Taoufik; Ben Jemaa, Mounir; Boujnah, Rachid; Chakroun, Mohamed; Daoud, Moncef; Gaha, Rafika; Kafsi, Naceur; Khalfallah, Ali; Slimane, Lotfi; Zaouali, Mohamed

2007-09-01

Since the first description of infective endocarditis, the profile of the disease has evolved continuously with stable incidence. However, epidemiological features are different in developing countries compared with western countries. To describe epidemiological, microbiological and outcome characteristics of infective endocarditis in Tunisia. This was a descriptive multicenter retrospective study of inpatients treated for infective endocarditis from 1991 to 2000. Charts of patients with possible or definite infective endocarditis according to the Duke criteria were included in the study. Four hundred and forty episodes of infective endocarditis among 435 patients (242 males, 193 females; mean (SD) age=32.4 (16.8) years, range 1-78 years) were reviewed. The most common predisposing heart disease was rheumatic valvular disease (45.2%). Infective endocarditis occurred on prosthetic valves in 17.3% of cases. Causative microorganisms were identified in 50.2% of cases: streptococci (17.3%), enterococci (3.9%), staphylococci (17.9%), and other pathogens (11.1%). Blood cultures were negative in 53.6% and no microorganism was identified in 49.8%. Early valve surgery was performed in 51.2% of patients. The in-hospital mortality was 20.6%. Infective endocarditis is still frequently associated with rheumatic disease among young adults in Tunisia, with a high frequency of negative blood cultures and high in-hospital mortality, given that the population affected is relatively young.

Alveolar Ridge Reconstruction with Titanium Meshes and Simultaneous Implant Placement: A Retrospective, Multicenter Clinical Study

PubMed Central

Paraud Freixas, Andres; Han, Chang-Hun; Bechara, Sohueil; Tawil, Isaac

2016-01-01

Objective. To evaluate horizontal bone gain and implant survival and complication rates in patients treated with titanium meshes placed simultaneously with dental implants and fixed over them. Methods. Twenty-five patients treated with 40 implants and simultaneous guided bone regeneration with titanium meshes (i–Gen®, MegaGen, Gyeongbuk, Republic of Korea) were selected for inclusion in the present retrospective multicenter study. Primary outcomes were horizontal bone gain and implant survival; secondary outcomes were biological and prosthetic complications. Results. After the removal of titanium meshes, the CBCT evaluation revealed a mean horizontal bone gain of 3.67 mm (±0.89). The most frequent complications were mild postoperative edema (12/25 patients: 48%) and discomfort after surgery (10/25 patients: 40%); these complications were resolved within one week. Titanium mesh exposure occurred in 6 patients (6/25 : 24%): one of these suffered partial loss of the graft and another experienced complete graft loss and implant failure. An implant survival rate of 97.5% (implant-based) and a peri-implant marginal bone loss of 0.43 mm (±0.15) were recorded after 1 year. Conclusions. The horizontal ridge reconstruction with titanium meshes placed simultaneously with dental implants achieved predictable satisfactory results. Prospective randomized controlled trials on a larger sample of patients are required to validate these positive outcomes. PMID:27999799

Bronchiectasis diagnosed after renal transplantation: a retrospective multicenter study.

PubMed

Dury, Sandra; Colosio, Charlotte; Etienne, Isabelle; Anglicheau, Dany; Merieau, Elodie; Caillard, Sophie; Rivalan, Joseph; Thervet, Eric; Essig, Marie; Babinet, François; Subra, Jean-François; Toubas, Olivier; Rieu, Philippe; Launois, Claire; Perotin-Collard, Jeanne-Marie; Lebargy, François; Deslée, Gaëtan

2015-11-07

Bronchiectasis is characterized by abnormal, permanent and irreversible dilatation of the bronchi, usually responsible for daily symptoms and frequent respiratory complications. Many causes have been identified, but only limited data are available concerning the association between bronchiectasis and renal transplantation. We conducted a retrospective multicenter study of cases of bronchiectasis diagnosed after renal transplantation in 14 renal transplantation departments (French SPIESSER group). Demographic, clinical, laboratory and CT scan data were collected. Forty-six patients were included (mean age 58.2 years, 52.2 % men). Autosomal dominant polycystic kidney disease (32.6 %) was the main underlying renal disease. Chronic cough and sputum (50.0 %) were the major symptoms leading to chest CT scan. Mean duration of symptoms before diagnosis was 1.5 years [0-12.1 years]. Microorganisms were identified in 22 patients, predominantly Haemophilus influenzae. Hypogammaglobulinemia was observed in 46.9 % patients. Bronchiectasis was usually extensive (84.8 %). The total bronchiectasis score was 7.4 ± 5.5 with a significant gradient from apex to bases. Many patients remained symptomatic (43.5 %) and/or presented recurrent respiratory tract infections (37.0 %) during follow-up. Six deaths (13 %) occurred during follow-up, but none were attributable to bronchiectasis. These results highlight that the diagnosis of bronchiectasis should be considered in patients with de novo respiratory symptoms after renal transplantation. Further studies are needed to more clearly understand the mechanisms underlying bronchiectasis in this setting.

Crestal sinus lift with sequential drills and simultaneous implant placement in sites with <5 mm of native bone: a multicenter retrospective study.

PubMed

Bernardello, Fabio; Righi, Davide; Cosci, Ferdinando; Bozzoli, Paolo; Soardi, Carlo Maria; Carlo, Maria Soardi; Spinato, Sergio

2011-12-01

The aim of this multicenter retrospective clinical study was to evaluate the survival rate of implants placed in the posterior maxilla with a residual bone height of <5 mm. One hundred seventeen patients, recruited from 6 different centers, had 134 implants placed below the maxillary sinus. The patient population consisted of 52 men and 65 women ranging in age from 39 to 78 years (mean age, 53.2 years). Sinus lift procedures were performed following a crestal approach using a specific sequence of drills (Cosci's technique). All implants were submerged. Periapical radiographs were obtained with a paralleling technique and were digitized. The pattern of bone remodeling was subsequently evaluated. The average (±SD) follow-up time was 48.2 months (±29.30 months; range, 24 to 120 months). Of the original 134 implants placed, 5 implants (3.7%) failed. The implant survival rate was 96.3%. The average residual bone height was 3.46 mm (±0.91 mm) at baseline. The average height of the alveolar crest in the treated implant sites was 9.94 ± 2.29 mm. The radiographic bone gain was 6.48 ± 2.38 mm. The investigation suggests that this crestal drill approach can be a successful sinus lifting procedure in a severe atrophic maxilla with <5 mm of crestal bone height.

AURORA: bariatric surgery registration in women of reproductive age - a multicenter prospective cohort study.

PubMed

Jans, Goele; Matthys, Christophe; Bel, Sarah; Ameye, Lieveke; Lannoo, Matthias; Van der Schueren, Bart; Dillemans, Bruno; Lemmens, Luc; Saey, Jean-Pierre; van Nieuwenhove, Yves; Grandjean, Pascale; De Becker, Ben; Logghe, Hilde; Coppens, Marc; Roelens, Kristien; Loccufier, Anne; Verhaeghe, Johan; Devlieger, Roland

2016-07-29

The expansion of the obesity epidemic is accompanied with an increase in bariatric procedures, in particular in women of reproductive age. The weight loss induced by the surgery is believed to reverse the negative impact of overweight and obesity on female reproduction, however, research is limited to in particular retrospective cohort studies and a growing number of small case-series and case-(control) studies. AURORA is a multicenter prospective cohort study. The main objective is to collect long-term data on reproductive outcomes before and after bariatric surgery and in a subsequent pregnancy. Women aged 18-45 years are invited to participate at 4 possible inclusion moments: 1) before surgery, 2) after surgery, 3) before 15 weeks of pregnancy and 4) in the immediate postpartum period (day 3-4). Depending on the time of inclusion, data are collected before surgery (T1), 3 weeks and 3, 6, 12 or x months after surgery (T2-T5) and during the first, second and third trimester of pregnancy (T6-T8), at delivery (T9) and 6 weeks and 6 months after delivery (T10-T11). Online questionnaires are send on the different measuring moments. Data are collected on contraception, menstrual cycle, sexuality, intention of becoming pregnant, diet, physical activity, lifestyle, psycho-social characteristics and dietary supplement intake. Fasting blood samples determine levels of vitamin A, D, E, K, B-1, B-12 and folate, albumin, total protein, coagulation parameters, magnesium, calcium, zinc and glucose. Participants are weighted every measuring moment. Fetal ultrasounds and pregnancy course and complications are reported every trimester of pregnancy. Breastfeeding is recorded and breast milk composition in the postpartum period is studied. AURORA is a multicenter prospective cohort study extensively monitoring women before undergoing bariatric surgery until a subsequent pregnancy and postpartum period. Retrospectively registered (July 2015 - NCT02515214 ).

The impact of the lung allocation score on short-term transplantation outcomes: a multicenter study.

PubMed

Kozower, Benjamin D; Meyers, Bryan F; Smith, Michael A; De Oliveira, Nilto C; Cassivi, Stephen D; Guthrie, Tracey J; Wang, Honkung; Ryan, Beverly J; Shen, K Robert; Daniel, Thomas M; Jones, David R

2008-01-01

The lung allocation score restructured the distribution of scarce donor lungs for transplantation. The algorithm ranks waiting list patients according to medical urgency and expected benefit after transplantation. The purpose of this study was to evaluate the impact of the lung allocation score on short-term outcomes after lung transplantation. A multicenter retrospective cohort study was performed with data from 5 academic medical centers. Results of patients undergoing transplantation on the basis of the lung allocation score (May 4, 2005 to May 3, 2006) were compared with those of patients receiving transplants the preceding year before the lung allocation score was implemented (May 4, 2004, to May 3, 2005). The study reports on 341 patients (170 before the lung allocation score and 171 after). Waiting time decreased from 680.9 +/- 528.3 days to 445.6 +/- 516.9 days (P < .001). Recipient diagnoses changed with an increase in idiopathic pulmonary fibrosis and a decrease in emphysema and cystic fibrosis (P = .002). Postoperatively, primary graft dysfunction increased from 14.1% (24/170) to 22.9% (39/171) (P = .04) and intensive care unit length of stay increased from 5.7 +/- 6.7 days to 7.8 +/- 9.6 days (P = .04). Hospital mortality and 1-year survival were the same between groups (5.3% vs 5.3% and 90% vs 89%, respectively; P > .6) This multicenter retrospective review of short-term outcomes supports the fact that the lung allocation score is achieving its objectives. The lung allocation score reduced waiting time and altered the distribution of lung diseases for which transplantation was done on the basis of medical necessity. After transplantation, recipients have significantly higher rates of primary graft dysfunction and intensive care unit lengths of stay. However, hospital mortality and 1-year survival have not been adversely affected.

Subjective perception of safety in healthy individuals working with 7 T MRI scanners: a retrospective multicenter survey.

PubMed

Fatahi, Mahsa; Demenescu, Liliana Ramona; Speck, Oliver

2016-06-01

To retrospectively assess perception of safety of healthy individuals working with human 7 Tesla (T) magnetic resonance imaging (MRI) scanners. A total of 66 healthy individuals with a mean age of 31 ± 7 years participated in this retrospective multicentre survey study. Nonparametric correlation analysis was conducted to evaluate the relation between self-reported perception of safety and prevalence of sensory effects while working with 7 T MRI scanners for an average 47 months. The results indicated that 98.5 % of the study participants had a neutral or positive feeling about safety aspects at 7 T MRI scanners. 45.5 % reported that they feel very safe and none of the participants stated that they feel moderately or very unsafe while working with 7 T MRI scanners. Perception of safety was not affected by the number of hours per week spent in the vicinity of the 7 T MRI scanner or the duration of experience with 7 T MRI. More than 50 % of individuals experienced vertigo and metallic taste while working with 7 T MRI scanners. However, participants' perceptions of safety were not affected by the prevalence of MR-related symptoms. The overall data indicated an average perception of a moderately safe work environment. To our knowledge, this study delineates the first attempt to assess the subjective safety perception among 7 T MRI workers and suggests further investigations are indicated.

QIN. Early experiences in establishing a regional quantitative imaging network for PET/CT clinical trials

PubMed Central

Doot, Robert K.; Thompson, Tove; Greer, Benjamin E.; Allberg, Keith C.; Linden, Hannah M.; Mankoff, David A.; Kinahan, Paul E.

2012-01-01

The Seattle Cancer Care Alliance (SCCA) is a Pacific Northwest regional network that enables patients from community cancer centers to participate in multicenter oncology clinical trials where patients can receive some trial-related procedures at their local center. Results of positron emission tomography (PET) scans performed at community cancer centers are not currently used in SCCA Network trials since clinical trials customarily accept results from only trial-accredited PET imaging centers located at academic and large hospitals. Oncologists would prefer the option of using standard clinical PET scans from Network sites in multicenter clinical trials to increase accrual of patients for whom additional travel requirements for imaging is a barrier to recruitment. In an effort to increase accrual of rural and other underserved populations to Network trials, researchers and clinicians at the University of Washington, SCCA and its Network are assessing feasibility of using PET scans from all Network sites in their oncology clinical trials. A feasibility study is required because the reproducibility of multicenter PET measurements ranges from approximately 3% to 40% at national academic centers. Early experiences from both national and local PET phantom imaging trials are discussed and next steps are proposed for including patient PET scans from the emerging regional quantitative imaging network in clinical trials. There are feasible methods to determine and characterize PET quantitation errors and improve data quality by either prospective scanner calibration or retrospective post hoc corrections. These methods should be developed and implemented in multicenter clinical trials employing quantitative PET imaging of patients. PMID:22795929

Early experiences in establishing a regional quantitative imaging network for PET/CT clinical trials.

PubMed

Doot, Robert K; Thompson, Tove; Greer, Benjamin E; Allberg, Keith C; Linden, Hannah M; Mankoff, David A; Kinahan, Paul E

2012-11-01

The Seattle Cancer Care Alliance (SCCA) is a Pacific Northwest regional network that enables patients from community cancer centers to participate in multicenter oncology clinical trials where patients can receive some trial-related procedures at their local center. Results of positron emission tomography (PET) scans performed at community cancer centers are not currently used in SCCA Network trials since clinical trials customarily accept results from only trial-accredited PET imaging centers located at academic and large hospitals. Oncologists would prefer the option of using standard clinical PET scans from Network sites in multicenter clinical trials to increase accrual of patients for whom additional travel requirements for imaging are a barrier to recruitment. In an effort to increase accrual of rural and other underserved populations to Network trials, researchers and clinicians at the University of Washington, SCCA and its Network are assessing the feasibility of using PET scans from all Network sites in their oncology clinical trials. A feasibility study is required because the reproducibility of multicenter PET measurements ranges from approximately 3% to 40% at national academic centers. Early experiences from both national and local PET phantom imaging trials are discussed, and next steps are proposed for including patient PET scans from the emerging regional quantitative imaging network in clinical trials. There are feasible methods to determine and characterize PET quantitation errors and improve data quality by either prospective scanner calibration or retrospective post hoc corrections. These methods should be developed and implemented in multicenter clinical trials employing quantitative PET imaging of patients. Copyright © 2012 Elsevier Inc. All rights reserved.

Caspofungin versus fluconazole as prophylaxis of invasive fungal infection in high-risk liver transplantation recipients: A propensity score analysis.

PubMed

Fortún, Jesús; Muriel, Alfonso; Martín-Dávila, Pilar; Montejo, Miguel; Len, Oscar; Torre-Cisneros, Julian; Carratalá, Jordi; Muñoz, Patricia; Fariñas, Carmen; Moreno, Asunción; Fresco, Gema; Goikoetxea, Josune; Gavaldá, Joan; Pozo, Juan Carlos; Bodro, Marta; Vena, Antonio; Casafont, Fernando; Cervera, Carlos; Silva, José Tiago; Aguado, José M

2016-04-01

Targeted prophylaxis has proven to be an efficient strategy in liver transplantation recipients (LTRs). The aim of this study was to compare the effectiveness and safety of caspofungin with that of fluconazole in high-risk (HR) LTRs. Caspofungin and fluconazole were compared in a multicenter, retrospective, cohort study in HR-LTRs in Spain. Outcomes were assessed at 180 days after transplantation. A propensity score approach was applied. During the study period (2005-2012), we analyzed 195 HR-LTRs from 9 hospitals. By type of prophylaxis, 97 patients received caspofungin and 98 received fluconazole. Of a total of 17 (8.7%) global invasive fungal infections (IFIs), breakthrough IFIs accounted for 11 (5.6%) and invasive aspergillosis (IA) accounted for 6 (3.1%). By univariate analysis, no differences were observed in the prevention of global IFIs. However, caspofungin was associated with a significant reduction in the rate of breakthrough IFIs (2.1% versus 9.2%, P = 0.04). In patients requiring dialysis (n = 62), caspofungin significantly reduced the frequency of breakthrough IFIs (P = 0.03). The propensity score analysis confirmed a significant reduction in the frequency of IA in patients receiving caspofungin (absolute risk reduction, 0.06; 95% confidence interval [CI], 0.001-0.11; P = 0.044). Linear regression analysis revealed a significant decrease in blood alanine aminotransferase levels and a significant increase in bilirubin levels after administration of caspofungin. Caspofungin and fluconazole have similar efficacy for the prevention of global IFIs in HR-LTRs in this observational, multicenter cohort study. However, caspofungin was associated with a significant reduction of breakthrough IFIs and, after adjusting for confounders, caspofungin was associated with a lower rate of IA. This benefit is probably more favorable in patients on dialysis. Caspofungin is safe in HR-LTRs, although bilirubin levels may be increased. © 2015 American Association for the Study of Liver Diseases.

Primary mucosal melanoma of the head and neck in Denmark, 1982-2012: Demographic and clinical aspects. A retrospective DAHANCA study.

PubMed

Lawaetz, Mads; Birch-Johansen, Fatima; Friis, Søren; Eriksen, Jesper G; Kiss, Katalin; Gade, Søren; Møller-Madsen, Maria; Pourbordbari, Negar; von Buchwald, Christian

2016-08-01

Background The study was performed to determine the epidemiological, clinical, and histopathological characteristics and prognosis of primary mucosal melanoma of the head and neck (MMHN) in Denmark. Material and methods This was a national retrospective multicenter study of patients diagnosed with MMHN between 1982 and 2012 in Denmark. Data were retrieved from national databases and patient records. Incidence trends were examined for the entire period. We prepared survival curves and performed univariate and multivariate analysis for the period 1992-2012 to identify possible prognostic factors. Results No significant trends in incidence were found in the study period. The three-year overall and disease-free survival rates for MMHN were 46.5% and 35.5%, respectively. Negative margins was an independent predictor of disease-free survival, and age below 65, absence of distant metastases, and low overall TNM stage were predictors of overall survival. Radiotherapy did not improve survival significantly. Recurrence rates were high, even for patients with negative margins. Conclusions MMHN remains a rare disease with a poor prognosis, particularly for patients aged over 65, those with distant metastasis, and those with advanced TNM stage. Importantly, the rate of recurrence is lowest in patients with negative margins.

Unknown primary squamous cell carcinoma of the head and neck: retrospective analysis of 80 cases.

PubMed

Mizuta, Masanobu; Kitamura, Morimasa; Tateya, Ichiro; Tamaki, Hisanobu; Tanaka, Shinzo; Asato, Ryo; Shinohara, Shogo; Takebayashi, Shinji; Maetani, Toshiki; Kitani, Yoshiharu; Kumabe, Yohei; Kojima, Tsuyoshi; Ushiro, Koji; Ichimaru, Kazuyuki; Honda, Keigo; Yamada, Koichiro; Omori, Koichi

2018-06-01

The management of patients with cervical metastasis in head and neck cancer of unknown primary (HNCUP) remains controversial. This current multicenter retrospective study investigated the treatment outcomes of patients with HNCUP. The study included patients who were treated curatively at 12 institutions in Japan from January 2006 to December 2015. Eighty patients with HNCUP were included. The median follow-up period was 34 months. The three-year overall survival (OS), disease-specific survival (DSS), regional relapse-free survival (RRFS), local progression-free survival (LPFS), and distant metastasis-free survival (DMFS) rates were 72.5%, 80.3%, 74.0%, 89.7%, and 86.9%, respectively. Nodal status was a significant factor for OS, DSS, RRFS, and DMFS; and extracapsular extension (ECE) was significant for OS and DSS. There was a distinct difference between the survival rates of patients with N1-2a and N2b-3 disease. RT was a significant positive factor for LPFS (3-year LPFS, RT 93.0% vs. no RT 83.0%, p = .043). For N2a as well as N1 disease without ECE, a single treatment modality, including ND or RT alone is acceptable. When ND alone is performed, thorough monitoring should be continued during follow-up to identify the emergence of the primary lesion.

Predictors of Enteral Autonomy in Children with Intestinal Failure: A Multicenter Cohort Study.

PubMed

Khan, Faraz A; Squires, Robert H; Litman, Heather J; Balint, Jane; Carter, Beth A; Fisher, Jeremy G; Horslen, Simon P; Jaksic, Tom; Kocoshis, Samuel; Martinez, J Andres; Mercer, David; Rhee, Susan; Rudolph, Jeffrey A; Soden, Jason; Sudan, Debra; Superina, Riccardo A; Teitelbaum, Daniel H; Venick, Robert; Wales, Paul W; Duggan, Christopher

2015-07-01

In a large cohort of children with intestinal failure (IF), we sought to determine the cumulative incidence of achieving enteral autonomy and identify patient and institutional characteristics associated with enteral autonomy. A multicenter, retrospective cohort analysis from the Pediatric Intestinal Failure Consortium was performed. IF was defined as severe congenital or acquired gastrointestinal diseases during infancy with dependence on parenteral nutrition (PN) >60 days. Enteral autonomy was defined as PN discontinuation >3 months. A total of 272 infants were followed for a median (IQR) of 33.5 (16.2-51.5) months. Enteral autonomy was achieved in 118 (43%); 36 (13%) remained PN dependent and 118 (43%) patients died or underwent transplantation. Multivariable analysis identified necrotizing enterocolitis (NEC; OR 2.42, 95% CI 1.33-4.47), care at an IF site without an associated intestinal transplantation program (OR 2.73, 95% CI 1.56-4.78), and an intact ileocecal valve (OR 2.80, 95% CI 1.63-4.83) as independent risk factors for enteral autonomy. A second model (n = 144) that included only patients with intraoperatively measured residual small bowel length found NEC (OR 3.44, 95% CI 1.36-8.71), care at a nonintestinal transplantation center (OR 6.56, 95% CI 2.53-16.98), and residual small bowel length (OR 1.04 cm, 95% CI 1.02-1.06 cm) to be independently associated with enteral autonomy. A substantial proportion of infants with IF can achieve enteral autonomy. Underlying NEC, preserved ileocecal valve, and longer bowel length are associated with achieving enteral autonomy. It is likely that variations in institutional practices and referral patterns also affect outcomes in children with IF. Copyright © 2015 Elsevier Inc. All rights reserved.

Efficacy of gemfibrozil in the primary prevention of atrial fibrillation in a large randomized controlled trial.

PubMed

Adabag, A Selcuk; Mithani, Salima; Al Aloul, Basel; Collins, Dorothea; Bertog, Stefan; Bloomfield, Hanna E

2009-05-01

Peroxisome proliferator-activated receptor alpha (PPARalpha) activators reduce inflammation and oxidative stress. Inflammation plays an important role in the initiation and maintenance of atrial fibrillation (AF). It has been suggested that PPARalpha activators may have antiarrhythmic properties, but no clinical data exist. The objective of this study was to investigate whether the PPARalpha activator gemfibrozil prevents or delays the development of AF in patients with coronary heart disease. We retrospectively analyzed the electrocardiograms (ECGs) performed in the Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial, a multicenter, randomized, double-blinded, secondary prevention trial of gemfibrozil and matching placebo. The ECGs were performed annually or biannually and when clinically indicated. Participants who were in AF on baseline ECG were excluded from the present analysis. Relative risk for AF was calculated from Cox regression with death as a competing risk factor. A total of 12,605 ECGs from 2,130 participants were interpreted (5.9 +/- 2.1 ECGs per participant, range 2-20). At baseline, the gemfibrozil (n = 1,070) and placebo (n = 1,060) groups were well matched. Mean age was 64.1 +/- 7.1 years. Over 4.4 +/- 1.5 years of follow-up, 123 (5.8%) participants developed new AF. There was no difference in AF incidence between the gemfibrozil and placebo groups (64/1,070 vs 59/1,060, respectively; P = .33). In Cox regression, the risk of AF was similar between the 2 study groups (hazard ratio 1.04, 95% CI 0.73-1.49, P = .82). In this post hoc analysis of a multicenter, double-blinded, randomized controlled trial, the PPARalpha activator gemfibrozil did not reduce the 4-year incidence of AF among men with coronary heart disease.

Towards a standardized nutrition and dietetics terminology for clinical practice: An Austrian multicenter clinical documentation analysis based on the International Classification of Functioning, Disability and Health (ICF)-Dietetics.

PubMed

Gäbler, Gabriele; Coenen, Michaela; Lycett, Deborah; Stamm, Tanja

2018-03-03

High quality, continuity and safe interdisciplinary healthcare is essential. Nutrition and dietetics plays an important part within the interdisciplinary team in many health conditions. In order to work more effectively as an interdisciplinary team, a common terminology is needed. This study investigates which categories of the ICF-Dietetics are used in clinical dietetic care records in Austria and which are most relevant to shared language in different medical areas. A national multicenter retrospective study was conducted to collect clinical dietetic care documentation reports. The analysis included the "best fit" framework synthesis, and a mapping exercise using the ICF Linking Rules. Medical diagnosis and intervention concepts were excluded from the mapping, since they are not supposed to be classified by the ICF. From 100 dietetic records, 307 concepts from 1807 quotations were extracted. Of these, 241 assessment, dietetics diagnosis, goal setting and evaluation concepts were linked to 153 ICF-Dietetics categories. The majority (91.3%) could be mapped to a precise ICF-Dietetics category. The highest number of ICF-Dietetics categories was found in the medical area of diabetes and metabolism and belonged to the ICF component Body Function, while very few categories were used from the component Participation and Environmental Factors. The integration of the ICF-Dietetics in nutrition and dietetic care process is possible. Moreover, it could be considered as a conceptual framework for interdisciplinary nutrition and dietetics care. However, a successful implementation of the ICF-Dietetics in clinical practice requires a paradigm shift from medical diagnosis-focused health care to a holistic perspective of functioning with more attention on Participation and Environmental Factors. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Multicenter study of endoscopic preoperative biliary drainage for malignant distal biliary obstruction

PubMed Central

Sasahira, Naoki; Hamada, Tsuyoshi; Togawa, Osamu; Yamamoto, Ryuichi; Iwai, Tomohisa; Tamada, Kiichi; Kawaguchi, Yoshiaki; Shimura, Kenji; Koike, Takero; Yoshida, Yu; Sugimori, Kazuya; Ryozawa, Shomei; Kakimoto, Toshiharu; Nishikawa, Ko; Kitamura, Katsuya; Imamura, Tsunao; Mizuide, Masafumi; Toda, Nobuo; Maetani, Iruru; Sakai, Yuji; Itoi, Takao; Nagahama, Masatsugu; Nakai, Yousuke; Isayama, Hiroyuki

2016-01-01

AIM: To determine the optimal method of endoscopic preoperative biliary drainage for malignant distal biliary obstruction. METHODS: Multicenter retrospective study was conducted in patients who underwent plastic stent (PS) or nasobiliary catheter (NBC) placement for resectable malignant distal biliary obstruction followed by surgery between January 2010 and March 2012. Procedure-related adverse events, stent/catheter dysfunction (occlusion or migration of PS/NBC, development of cholangitis, or other conditions that required repeat endoscopic biliary intervention), and jaundice resolution (bilirubin level < 3.0 mg/dL) were evaluated. Cumulative incidence of jaundice resolution and dysfunction of PS/NBC were estimated using competing risk analysis. Patient characteristics and preoperative biliary drainage were also evaluated for association with the time to jaundice resolution and PS/NBC dysfunction using competing risk regression analysis. RESULTS: In total, 419 patients were included in the study (PS, 253 and NBC, 166). Primary cancers included pancreatic cancer in 194 patients (46%), bile duct cancer in 172 (41%), gallbladder cancer in three (1%), and ampullary cancer in 50 (12%). The median serum total bilirubin was 7.8 mg/dL and 324 patients (77%) had ≥ 3.0 mg/dL. During the median time to surgery of 29 d [interquartile range (IQR), 30-39 d]. PS/NBC dysfunction rate was 35% for PS and 18% for NBC [Subdistribution hazard ratio (SHR) = 4.76; 95%CI: 2.44-10.0, P < 0.001]; the pig-tailed tip was a risk factor for PS dysfunction. Jaundice resolution was achieved in 85% of patients and did not depend on the drainage method (PS or NBC). CONCLUSION: PS has insufficient patency for preoperative biliary drainage. Given the drawbacks of external drainage via NBC, an alternative method of internal drainage should be explored. PMID:27076764

Efficacy of Alteplase® in a mouse model of acute ischemic stroke: a retrospective pooled analysis

PubMed Central

Orset, Cyrille; Haelewyn, Benoit; Allan, Stuart M.; Ansar, Saema; Campos, Francesco; Cho, Tae Hee; Durand, Anne; El Amki, Mohamad; Fatar, Marc; Garcia-Yébenes, Isaac; Gauberti, Maxime; Grudzenski, Saskia; Lizasoain, Ignacio; Lo, Eng; Macrez, Richard; Margaill, Isabelle; Maysami, Samaneh; Meairs, Stephen; Nighoghossian, Norbert; Orbe, Josune; Paramo, Jose Antonio; Parienti, Jean-Jacques; Rothwell, Nancy J.; Rubio, Marina; Waeber, Christian; Young, Alan R.

2016-01-01

Background and purpose The debate over the fact that experimental drugs proposed for the treatment of stroke fail in the translation to the clinical situation, has attracted considerable attention in the literature. In this context, we present a retrospective pooled analysis of a large dataset from pre-clinical studies, in order to examine the effects of early versus late administration of intravenous recombinant tissue type plasminogen activator (rt-PA). Methods We collected data from 26 individual studies from 9 international centers (13 researchers, 716 animals) that compared rt-PA to controls, in a unique mouse model of thromboembolic stroke induced by an in situ injection of thrombin into the middle cerebral artery. Studies were classified into early (<3h) versus late (≥3h) drug administration. Final infarct volumes, assessed by histology or MRI, were compared in each study and the absolute differences were pooled in a random-effect meta-analysis. The influence of time of administration was tested. Results When compared to saline controls, early rt-PA administration was associated with a significant benefit (absolute difference = −6.63 mm3; 95%CI, −9.08 to −4.17; I2=76%) whereas late rt-PA treatment showed a deleterious effect (+5.06 mm3; 95%CI, +2.78 to +7.34; I2=42%, Pint<0.00001). Results remained unchanged following subgroup analyses. Conclusion Our results provide the basis needed for the design of future pre-clinical studies on recanalization therapies using this model of thromboembolic stroke in mice. The power analysis reveals that a multi-center trial would require 123 animals per group instead of 40 for a single center trial. PMID:27032444

Ventricular fibrillation in acute myocardial infarction in Spanish patients: Results of the ARIAM database.

PubMed

Ruiz-Bailén, Manuel; Aguayo de Hoyos, Eduardo; Ruiz-Navarro, Silvia; Issa-Khozouz, Ziad; Reina-Toral, Antonio; Díaz-Castellanos, Miguel Angel; Rodríguez-García, Juan-José; Torres-Ruiz, Juan Miguel; Cárdenas-Cruz, Antonio; Camacho-Víctor, Angel

2003-08-01

The aim of this study has been to investigate the factors predisposing to primary or secondary ventricular fibrillation (VF) and the prognosis in Spanish patients with acute myocardial infarction (AMI) during their admission to the intensive care unit or the coronary care unit. A retrospective, observational study. The intensive care units and coronary care units of 119 Spanish hospitals. A retrospective cohort study including all the AMI patients listed in the ARIAM registry (Analysis of Delay in Acute Myocardial Infarction), a Spanish multicenter study. The study period was January 1995 to January 2001. Factors associated with the onset of VF were studied by univariate analysis. Multivariate analysis was used to evaluate the independent factors for the onset of VF and for mortality. A total of 17,761 patients with AMI were included in the study; 964 (5.4%) developed VF (primary in 735 patients, secondary in 229). In multivariate analysis, the variables that continued to show an association with the development of VF were the Killip and Kimball class, peak creatine kinase, APACHE II score, age, and time from the onset of symptoms to the initiation of thrombolysis. The mortality in the patients with any VF was 31.8% (27.8% in patients with primary VF and 49.1% in patients with secondary VF). The development of VF is an independent predictive factor for mortality in patients with AMI, with a crude odds ratio of 5.12 (95% confidence interval, 4.41-5.95) and an adjusted odds ratio of 2.73 (95% confidence interval, 2.12-3.51). Despite the considerable improvement in the treatment of AMI in recent years, the onset of either primary or secondary VF is associated with a poor prognosis. It is usually accompanied by extensive necrosis.

Review and Analysis of Publication Trends over Three Decades in Three High Impact Medicine Journals.

PubMed

Ivanov, Alexander; Kaczkowska, Beata A; Khan, Saadat A; Ho, Jean; Tavakol, Morteza; Prasad, Ashok; Bhumireddy, Geetha; Beall, Allan F; Klem, Igor; Mehta, Parag; Briggs, William M; Sacchi, Terrence J; Heitner, John F

2017-01-01

Over the past three decades, industry sponsored research expanded in the United States. Financial incentives can lead to potential conflicts of interest (COI) resulting in underreporting of negative study results. We hypothesized that over the three decades, there would be an increase in: a) reporting of conflict of interest and source of funding; b) percentage of randomized control trials c) number of patients per study and d) industry funding. Original articles published in three calendar years (1988, 1998, and 2008) in The Lancet, New England Journal of Medicine and Journal of American Medical Association were collected. Studies were reviewed and investigational design categorized as prospective and retrospective clinical trials. Prospective trials were categorized into randomized or non-randomized and single-center or multi-center trials. Retrospective trials were categorized as registries, meta-analyses and other studies, mostly comprising of case reports or series. Study outcomes were categorized as positive or negative depending on whether the pre-specified hypothesis was met. Financial disclosures were researched for financial relationships and profit status, and accordingly categorized as government, non-profit or industry sponsored. Studies were assessed for reporting COI. 1,671 original articles were included in this analysis. Total number of published studies decreased by 17% from 1988 to 2008. Over 20 year period, the proportion of prospective randomized trials increased from 22 to 46% (p < 0.0001); whereas the proportion of prospective non-randomized trials decreased from 59% to 27% (p < 0.001). There was an increase in the percentage of prospective randomized multi-center trials from 11% to 41% (p < 0.001). Conversely, there was a reduction in non-randomized single-center trials from 47% to 10% (p < 0.001). Proportion of government funded studies remained constant, whereas industry funded studies more than doubled (17% to 40%; p < 0.0001). The number of studies with negative results more than doubled (10% to 22%; p<0.0001). While lack of funding disclosure decreased from 35% to 7%, COI reporting increased from 2% to 84% (p < 0.0001). Improved reporting of COI, clarity in financial sponsorship, increased publication of negative results in the setting of larger and better designed clinical trials represents a positive step forward in the scientific publications, despite the higher percentage of industry funded studies.

A retrospective multicenter study of carbon-ion radiotherapy for major salivary gland carcinomas: Subanalysis of J-CROS 1402 HN.

PubMed

Hayashi, Kazuhiko; Koto, Masashi; Demizu, Yusuke; Saitoh, Jun-Ichi; Suefuji, Hiroaki; Okimoto, Tomoaki; Ohno, Tatsuya; Shioyama, Yoshiyuki; Takagi, Ryo; Ikawa, Hiroaki; Nemoto, Kenji; Nakano, Takashi; Kamada, Tadashi

2018-03-01

A retrospective multicenter study was carried out to assess the clinical outcomes of carbon-ion radiotherapy for head and neck malignancies (Japan Carbon-Ion Radiation Oncology Study Group [J-CROS] study: 1402 HN). We evaluated the safety and efficacy of carbon-ion radiotherapy in patients with major salivary gland carcinoma. Sixty-nine patients treated with carbon-ion radiotherapy at four Japanese institutions were analyzed. Thirty-three patients (48%) had adenoid cystic carcinomas, 10 (14%) had mucoepidermoid carcinomas, and 26 (38%) had other disease types. Three patients (4%) had T1 disease, 8 (12%) had T2, 25 (36%) had T3, and 33 (48%) had T4. The median radiation dose was 64 Gy (relative biological effectiveness) in 16 fractions. The median gross tumor volume was 27 mL. The median follow-up period was 32.7 months. The 3-year local control rate and overall survival rate were 81% and 94%, respectively. Regarding acute toxicities, seven patients had grade 3 mucositis and seven had grade 3 dermatitis. Regarding late toxicities, one patient had grade 3 dysphagia and one had a grade 3 brain abscess. No grade 4 or worse late reactions were observed. In conclusion, definitive carbon-ion radiotherapy was effective with acceptable toxicity for major salivary gland carcinomas. © 2018 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Antibiotic resistance of Helicobacter pylori in Chinese children: A multicenter retrospective study over 7 years.

PubMed

Li, Lan; Ke, Yini; Yu, Chaohui; Li, Guogang; Yang, Ningmin; Zhang, Jianzhong; Li, Youming

2017-06-01

To determine the prevalence of resistance to metronidazole, clarithromycin, levofloxacin, amoxicillin, and furazolidone in Helicobacter pylori isolated from Chinese children. This multicenter retrospective study was conducted from January 2009 to December 2015. A total of 1746 isolates of H. pylori were collected from nine areas of Zhejiang province in the southeast coastal region of China. H. pylori strains were examined for antibiotics susceptibility by agar dilution method. The resistance rates were 75.20% for metronidazole, 16.38% for clarithromycin, 6.70% for levofloxacin, 0.06% for amoxicillin, and 0.06% for furazolidone. The pattern of H. pylori antibiotic resistance demonstrated no significant changes in the rates of resistance to clarithromycin, amoxicillin, furazolidone, and metronidazole over 7 years. A significant trend of increasing resistance to metronidazole was observed as children aged, but a downward trend in clarithromycin resistance was observed as children aged. No difference in the resistance to other antibiotics was observed among different age groups. Also, there was no significant difference between male and female subjects in rates of resistance to these five types of antibiotics. The predominant dual resistance to metronidazole and clarithromycin was presented in 10.65% of the isolates. The resistance rates of H. pylori in children from southeast coastal region of China were very high to metronidazole, moderate to clarithromycin and levofloxacin, and low to amoxicillin and furazolidone. It is important to continue monitoring the resistance profiles of H. pylori isolated in this region. © 2017 John Wiley & Sons Ltd.

The Role of Azacitidine in the Treatment of Elderly Patients with Acute Myeloid Leukemia: Results of a Retrospective Multicenter Study

PubMed Central

Tombak, Anıl; Uçar, Mehmet Ali; Akdeniz, Aydan; Tiftik, Eyüp Naci; Gören Şahin, Deniz; Akay, Olga Meltem; Yıldırım, Murat; Nevruz, Oral; Kis, Cem; Gürkan, Emel; Medeni Solmaz, Şerife; Özcan, Mehmet Ali; Yıldırım, Rahşan; Berber, İlhami; Erkurt, Mehmet Ali; Tuğlular, Tülin Fıratlı; Tarkun, Pınar; Yavaşoğlu, İrfan; Doğu, Mehmet Hilmi; Sarı, İsmail; Merter, Mustafa; Özcan, Muhit; Yıldızhan, Esra; Kaynar, Leylagül; Mehtap, Özgür; Uysal, Ayşe; Şahin, Fahri; Salim, Ozan; Sungur, Mehmet Ali

2016-01-01

Objective: In this study, we aimed to investigate the efficacy and safety of azacitidine (AZA) in elderly patients with acute myeloid leukemia (AML), including patients with >30% bone marrow (BM) blasts. Materials and Methods: In this retrospective multicenter study, 130 patients of ≥60 years o ld who were ineligible for intensive chemotherapy or had progressed despite conventional treatment were included. Results: The median age was 73 years and 61.5% of patients had >30% BM blasts. Patients received AZA for a median of four cycles (range: 1-21). Initial overall response [including complete remission (CR)/CR with incomplete recovery/partial remission] was 36.2%. Hematologic improvement (HI) of any kind was documented in 37.7% of all patients. HI was also documented in 27.1% of patients who were unresponsive to treatment. Median overall survival (OS) was 18 months for responders and 12 months for nonresponders (p=0.005). In the unresponsive patient group, any HI improved OS compared to patients without any HI (median OS was 14 months versus 10 months, p=0.068). Eastern Cooperative Oncology Group performance status of <2, increasing number of AZA cycles (≥5 courses), and any HI predicted better OS. Age, AML type, and BM blast percentage had no impact. Conclusion: We conclude that AZA is effective and well tolerated in elderly comorbid AML patients, irrespective of BM blast count, and HI should be considered a sufficient response to continue treatment with AZA. PMID:27095141

Evaluation of 5-year-old children with complete cleft lip and palate: Multicenter study. Part 1: Lip and nose aesthetic results.

PubMed

Dissaux, Caroline; Bodin, Frédéric; Grollemund, Bruno; Picard, Arnaud; Vazquez, Marie-Paule; Morand, Béatrice; James, Isabelle; Kauffmann, Isabelle; Bruant-Rodier, Catherine

2015-12-01

Cleft surgery is marked by all the controversies and the multiplication of protocols, as it has been shown by the Eurocleft study. The objective of this pilot study is to start a comparison and analyzing procedure between primary surgical protocols in French centers. Four French centers with different primary surgical protocols for cleft lip and palate repair, have accepted to be involved in this retrospective study. In each center, 20 consecutive patients with complete cleft lip and palate (10 UCLP and 10 BCLP per center), non syndromic, have been evaluated at a mean age of 5 [4,6]. In this first part, the aesthetic results of nose and lip repair were assessed based on the scale established by Mortier et al. (1997). Considering nose outcome, primary cleft repair surgery including a nasal dissection gives a statistically significant benefit in terms of septum deviation. Considering lip result, muscular dehiscence rate is significantly higher in BCLP patients with a two-stage lip closure. The centers using Millard one-stage lip closure do not have uniform results. For UCLP patients, the quality of scar is not statistically different between Skoog and Millard techniques. Primary results based on a simple, reproducible evaluation protocol. Extension to other centers required. Therapeutic study. Level III/retrospective multicenter comparative study. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis: a multicenter retrospective study of 377 adult patients from the United States.

PubMed

Micheletti, Robert G; Chiesa-Fuxench, Zelma; Noe, Megan H; Stephen, Sasha; Aleshin, Maria; Agarwal, Ashwin; Boggs, Jennifer; Cardones, Adela R; Chen, Jennifer K; Cotliar, Jonathan; Davis, Mark Dp; Dominguez, Arturo; Fox, Lindy P; Gordon, Shayna; Hamrick, Ronald; Ho, Baran; Hughey, Lauren C; Jones, Larry M; Kaffenberger, Benjamin H; Kindley, Kimball; Kroshinsky, Daniela; Kwong, Bernice Y; Miller, Daniel D; Mostaghimi, Arash; Musiek, Amy; Ortega-Loayza, Alex G; Patel, Raj; Posligua, Alba; Rani, Monica; Saluja, Sandeep; Sharon, Victoria R; Shinkai, Kanade; John, Jessica St; Strickland, Nicole; Summers, Erika M; Sun, Natalie; Wanat, Karolyn A; Wetter, David A; Worswick, Scott; Yang, Caroline; Margolis, David J; Gelfand, Joel M; Rosenbach, Misha

2018-05-11

Stevens-Johnson syndrome / toxic epidermal necrolysis (SJS/TEN) is a rare, severe mucocutaneous reaction with few large cohorts reported. This multicenter retrospective study included patients with SJS/TEN seen by inpatient consultative dermatologists at 18 academic medical centers in the United States. 377 adult patients with SJS/TEN between 1/1/2000 and 6/1/2015 were entered, including 69.0% from 2010 onward. The most frequent cause of SJS/TEN was medication reaction (89.7%), most often trimethoprim / sulfamethoxazole (27.2%). The majority of patients were managed in an intensive care (27.2%) or burn unit (41.0%). Most received pharmacologic therapy (70.7%) versus supportive care alone (29.3%)-typically corticosteroids (42.5%), IVIG (35.3%), or both therapies (20.3%). Based on Day 1 SCORTEN predicted mortality, 78 in-hospital deaths were expected (21%), while the observed mortality of 54 patients (14.7%) was significantly lower (SMR 0.70; CI 0.58, 0.79). Stratified by therapy received, the standardized mortality ratio was lowest among those receiving both steroids and IVIG (0.52; CI 0.21, 0.79). This large cohort provides contemporary information regarding US patients with SJS/TEN. Mortality, while substantial, was significantly lower than predicted. While the precise role of pharmacotherapy remains unclear, co-administration of corticosteroids and IVIG, among other therapies, may warrant further study. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Evaluation of 5-year-old children with complete cleft lip and palate: Multicenter study. Part 2: Functional results.

PubMed

Dissaux, Caroline; Grollemund, Bruno; Bodin, Frédéric; Picard, Arnaud; Vazquez, Marie-Paule; Morand, Béatrice; James, Isabelle; Kauffmann, Isabelle; Bruant-Rodier, Catherine

2016-02-01

Cleft surgery is marked by all the controversies and the multiplication of protocols, as it has been shown by the Eurocleft study. The objective of this pilot study is to start a comparison and analyzing procedure between primary surgical protocols in French centers. Four French centers with different primary surgical protocols for cleft lip and palate repair, have accepted to be involved in this retrospective study. In each center, 20 consecutive patients with complete cleft lip and palate (10 UCLP, 10 BCLP per center), non syndromic, have been evaluated at a mean age of 5 [range, 4-6]. In this second part, maxillary growth and palatine morphology were assessed on clinical examination and on dental casts (Goslon score). Speech was also evaluated clinically (Borel-maisonny classification) and by Aerophonoscope. Veau-Wardill-Killner palatoplasty involves a higher rate of transversal maxillary deficiency and retromaxillary. The fistula rate is statistically lower with tibial periosteum graft hard palate closure but this technique seems to give retromaxillary. Malek and Talmant two-stage-palatoplasty techniques reach Goslon scores of 1 or 2. Considering speech, Sommerlad intravelar veloplasty got higher outcomes. Primary results. Extension to other centers required. The two-stage palatoplasty, including a Sommerlad intravelar veloplasty seems to have the less negative impact on maxillary growth, and to give good speech outcomes. Therapeutic study. Level III/retrospective multicenter comparative study. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

CMV Infection in Pediatric Severe Ulcerative Colitis - A Multicenter Study from the Pediatric IBD Porto Group of ESPGHAN.

PubMed

Cohen, Shlomi; Martinez-Vinson, Christine; Aloi, Marina; Turner, Dan; Assa, Amit; de Ridder, Lissy; Wolters, Victorien M; de Meij, Tim; Alvisi, Patrizia; Bronsky, Jiri; Kopylov, Uri

2017-07-31

Data on the clinical course and outcomes of pediatric patients with cytomegalovirus (CMV) infection complicating acute severe ulcerative colitis (ASC) are very limited. The aim of our study was to compare outcomes of children with ASC who were CMV-positive or CMV-negative. This was a multicenter retrospective case-controlled study, from centers affiliated with the Pediatric IBD Porto Group of ESPGHAN. We included CMV -positive children hospitalized for ASC and compared their colectomy rate during hospitalization and up to 1 year thereafter, matched with CMV-negative controls. A total of 56 children were included; 15 CMV-positive and 41 CMV-negative. More CMV-positive patients were resistant to intravenous corticosteroids as compare to CMV negative (93% and 56% respectively, p=0.009). Fourteen of the CMV-positive children (93%) were treated with ganciclovir (5/14 (36%) with 5mg/kg and 9/14 (64%) with 10mg/kg). During hospitalization, 3 (20%) CMV-positive and 3 (7.8%) CMV-negative patients required colectomy (p=0.17). By 12 months, 5 (33%) and 5 (13%) CMV-positive and negative patients required colectomy, respectively (p=0.049); the significance was not retained on multivariate analysis. A higher prevalence of CMV-positivity was found in pediatric UC patients who required colectomy within 12 months of hospitalization for ASC. Further studies are needed to clarify the impact of CMV infection on the outcome of acute severe colitis in pediatric patients.

Safety and Efficacy of the ACE-Inhibitor Ramipril in Alport Syndrome: The Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III EARLY PRO-TECT Alport Trial in Pediatric Patients.

PubMed

Gross, Oliver; Friede, Tim; Hilgers, Reinhard; Görlitz, Anke; Gavénis, Karsten; Ahmed, Raees; Dürr, Ulrike

2012-01-01

Introduction. Retrospective observational data show that ACE-inhibitor therapy delays renal failure and improves life expectancy in Alport patients with proteinuria. The EARLY PRO-TECT Alport trial assesses the safety and efficacy of early therapy onset with ramipril in pediatric Alport patients. Methods and analysis. This double-blind, randomized, placebo-controlled, multicenter phase III trial (NCT01485978; EudraCT-number 2010-024300-10) includes 120 pediatric patients aged 24 months to 18 years with early stages of Alport syndrome (isolated hematuria or microalbuminuria). From March 2012, up to 80 patients will be randomized 1:1 to ramipril or placebo. In the event of disease progression during 3-year treatment, patients are unblinded and ramipril is initiated, if applicable. Approximately 40 patients receive open-label ramipril contributing to the safety database. Primary end-points are "time to progression to next disease level" and "incidence of adverse drug events before disease progression." Treatment effect estimates from the randomized comparison and Alport registry data will be combined in supportive analyses to maximize evidence. Conclusion. Without this trial, ACE inhibitors may become standard off-label treatment in Alport syndrome without satisfactory evidence base. The results are expected to be of relevance for therapy of all pediatric patients with kidney disease, and the trial protocol might serve as a model for other rare pediatric glomerulopathies.

Effect of blood transfusion on outcome after major burn injury: a multicenter study.

PubMed

Palmieri, Tina L; Caruso, Daniel M; Foster, Kevin N; Cairns, Bruce A; Peck, Michael D; Gamelli, Richard L; Mozingo, David W; Kagan, Richard J; Wahl, Wendy; Kemalyan, Nathan A; Fish, Joel S; Gomez, Manuel; Sheridan, Robert L; Faucher, Lee D; Latenser, Barbara A; Gibran, Nicole S; Klein, Robert L; Solem, Lynn D; Saffle, Jeffrey R; Morris, Stephen E; Jeng, James C; Voigt, David; Howard, Pamela A; Molitor, Fred; Greenhalgh, David G

2006-06-01

To delineate blood transfusion practices and outcomes in patients with major burn injury. Patients with major burn injury frequently require multiple blood transfusions; however, the effect of blood transfusion after major burn injury has had limited study. Multicenter retrospective cohort analysis. Regional burn centers throughout the United States and Canada. Patients admitted to a participating burn center from January 1 through December 31, 2002, with acute burn injuries of >or=20% total body surface area. Outcome measurements included mortality, number of infections, length of stay, units of blood transfused in and out of the operating room, number of operations, and anticoagulant use. A total of 21 burn centers contributed data on 666 patients; 79% of patients survived and received a mean of 14 units of packed red blood cells during their hospitalization. Mortality was related to patient age, total body surface area burn, inhalation injury, number of units of blood transfused outside the operating room, and total number of transfusions. The number of infections per patient increased with each unit of blood transfused (odds ratio, 1.13; p<.001). Patients on anticoagulation during hospitalization received more blood than patients not on anticoagulation (16.3+/-1.5 vs. 12.3+/-1.5, p<.001). The number of transfusions received was associated with mortality and infectious episodes in patients with major burns even after factoring for indices of burn severity. The utilization of blood products in the treatment of major burn injury should be reserved for patients with a demonstrated physiologic need.

Clinical experience with adalimumab in a multicenter Swiss cohort of patients with Crohn's disease.

PubMed

Nichita, Cristina; Stelle, Marc; Vavricka, Stephan; El-Wafa Ali, Abdou; Ballabeni, Pierluigi; de Saussure, Philippe; Straumann, Alex; Rogler, Gerhard; Michetti, Pierre

2010-01-01

Controlled clinical trials have demonstrated the efficacy and safety of adalimumab in patients with moderate-to-severe Crohn's disease (CD), but there is, however, only limited long-term experience with adalimumab in daily practice. To assess the long-term effectiveness and safety of adalimumab in a multicenter cohort of practice-based patients with moderate-to-severe CD. We retrospectively reviewed the charts of CD patients who received adalimumab over a 3-year period. Disease severity was scored using the Harvey-Bradshaw index (HBI). Remission was defined as an HBI of 3 points at evaluation compared to the baseline. Univariate logistic regression analysis was used to identify the predictive variables associated with response. The charts of 55 patients were reviewed; remission and response rates observed at weeks 4-6 were 52.7 and 83.6%, respectively. Remission was maintained at weeks 12, 24 and 52 in 89.6, 72.4 and 44.7% of patients, respectively. Remission and response rates were not influenced by smoking status, disease location or duration, the first month total dose, or previous infliximab therapy. The remission rate at weeks 4-6 was significantly higher in patients intolerant of infliximab as compared to those who lost response to this drug. Adalimumab was well tolerated overall. Adalimumab can be considered a suitable option in patients with moderate-to-severe CD, demonstrating sustained long-term effectiveness. Copyright (c) 2010 S. Karger AG, Basel.

Multi-center prediction of hemorrhagic transformation in acute ischemic stroke using permeability imaging features.

PubMed

Scalzo, Fabien; Alger, Jeffry R; Hu, Xiao; Saver, Jeffrey L; Dani, Krishna A; Muir, Keith W; Demchuk, Andrew M; Coutts, Shelagh B; Luby, Marie; Warach, Steven; Liebeskind, David S

2013-07-01

Permeability images derived from magnetic resonance (MR) perfusion images are sensitive to blood-brain barrier derangement of the brain tissue and have been shown to correlate with subsequent development of hemorrhagic transformation (HT) in acute ischemic stroke. This paper presents a multi-center retrospective study that evaluates the predictive power in terms of HT of six permeability MRI measures including contrast slope (CS), final contrast (FC), maximum peak bolus concentration (MPB), peak bolus area (PB), relative recirculation (rR), and percentage recovery (%R). Dynamic T2*-weighted perfusion MR images were collected from 263 acute ischemic stroke patients from four medical centers. An essential aspect of this study is to exploit a classifier-based framework to automatically identify predictive patterns in the overall intensity distribution of the permeability maps. The model is based on normalized intensity histograms that are used as input features to the predictive model. Linear and nonlinear predictive models are evaluated using a cross-validation to measure generalization power on new patients and a comparative analysis is provided for the different types of parameters. Results demonstrate that perfusion imaging in acute ischemic stroke can predict HT with an average accuracy of more than 85% using a predictive model based on a nonlinear regression model. Results also indicate that the permeability feature based on the percentage of recovery performs significantly better than the other features. This novel model may be used to refine treatment decisions in acute stroke. Copyright © 2013 Elsevier Inc. All rights reserved.

National registry of patients with systemic lupus erythematosus of the Spanish Society of Rheumatology: objectives and methodology.

PubMed

Rúa-Figueroa, Iñigo; López-Longo, Francisco Javier; Calvo-Alén, Jaime; Galindo-Izquierdo, María; Loza, Estíbaliz; García de Yebenes, M Jesús; Pego-Reigosa, José M

2014-01-01

To describe the objectives, design and methods of the Spanish Society of Rheumatology systemic lupus erythematosus (SLE) registry (RELESSER). Multicenter, hospital-based registry, with retrospective collection of data from a large representative sample of adult patients with SLE (1997 ACR criteria) attending Spanish rheumatology services. The registry includes demographic data, frequent and infrequent (<1%) clinical manifestations, information about activity, damage, severity, comorbidity, treatments and mortality, collecting 359 variables per patient, with highly standardized definitions. We performed a preliminary descriptive analysis of the data. Forty-five centers were involved and 4,024 SLE patients (91% with ≥ 4 ACR criteria) have been included; 90% are women and 93% caucasians, with a median age at diagnosis of 33 years, median disease duration: 120 months, median follow-up duration: 104 months; 3,222 (81%) of the patients are in active follow-up and 591 (14%) were lost to follow-up. The median values of the SELENA-SLEDAI score, SLICC/ACR damage index and Katz severity index have been 2, 1 and 2, respectively. A total of 211 patients (6%) died. RELESSER represents the largest European SLE registry built to date, providing comprehensive and reliable information on SLE manifestations, disease status, comorbid conditions and treatments in daily clinical practice. RELESSER is constituted as a tool of great potential for multicenter clinical research in SLE. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Predictive factors for a one-year improvement in nontuberculous mycobacterial pulmonary disease: An 11-year retrospective and multicenter study.

PubMed

Cadelis, Gilbert; Ducrot, Rodolphe; Bourdin, Arnaud; Rastogi, Nalin

2017-08-01

Nontuberculous mycobacterial pulmonary disease (NTM-PD) has become an emerging infectious disease and is responsible for more deaths than tuberculosis in industrialized countries. NTM-PD mortality remains high in some series reportedly ranging from 25% to 40% at five years and often due to unfavorable evolution of NTM-PD despite established treatment. The purpose of our study was to search for early factors that could predict the favorable or unfavorable evolution of NTM-PD at the first year of treatment. In this retrospective and multicenter study, we selected 119 patients based on clinical, radiological and microbiological data from 2002 to 2012 from three French university hospitals (Guadeloupe, Martinique, Montpellier) with definite (meeting the criteria of the American Thoracic Society and the Infectious Disease Society of America in 2007; ATS/IDSA) or probable (one positive sputum culture) NTM-PD. We compared two patient groups: those who improved at one year (clinical symptoms, radiological lesions and microbiology data) and those who did not improve at one year. The data were analyzed for all patients as well as for subgroups by gender, HIV-positive patients, and Mycobacterium avium complex (MAC) infection. The average patient age was 50 years ± 19.4; 58% had respiratory comorbidities, 24% were HIV positive and 19% had cystic fibrosis. Coughing concerned 66% of patients and bronchiectasis concerned 45%. The most frequently isolated NTM were MAC (46%). 57% (n = 68) of patients met the ATS criteria and improved status concerned 38.6% (n = 46). The improvement factors at one year of NTM-PD were associated with the duration of ethambutol treatment: (Odds ratio adjusted [ORa]: 2.24, 95% Confidence interval [CI]; 2.11-3.41), HIV-positive status: (ORa: 3.23, 95% CI; 1.27-8.45), and male gender: (ORa: 2.34, 95% CI; 1.26-8.16). For the group with NTM-PD due to MAC, improvement was associated with the duration of macrolide treatment (ORa: 3.27, 95% CI; 1.88-7.30) and an age <50 years (ORa: 1.88, 95% CI; 1.55-8.50). In this retrospective multicenter study, improvement at one year in patients with definite or probable NTM-PD was associated with the duration of ethambutol treatment, HIV-positive status and male gender. For the group of patients infected with MAC, improvement was associated with the duration of macrolide treatment and an age <50 years. Identifying predictors of improvement at one year of NTM-PD is expected to optimize the management of the disease in its early stages.

Multicenter review of robotic versus laparoscopic ventral hernia repair: is there a role for robotics?

PubMed

Walker, Peter A; May, Audriene C; Mo, Jiandi; Cherla, Deepa V; Santillan, Monica Rosales; Kim, Steven; Ryan, Heidi; Shah, Shinil K; Wilson, Erik B; Tsuda, Shawn

2018-04-01

The utilization of robotic platforms for general surgery procedures such as hernia repair is growing rapidly in the United States. A limited amount of data are available evaluating operative outcomes in comparison to standard laparoscopic surgery. We completed a retrospective review comparing robotic and laparoscopic ventral hernia repair to provide safety and outcomes data to help design a future prospective trial design. A retrospective review of 215 patients undergoing ventral hernia repair (142 robotic and 73 laparoscopic) was completed at two large academic centers. Primary outcome measure evaluated was recurrence. Secondary outcomes included incidence of primary fascial closure, and surgical site occurrences. Propensity for treatment match comparison demonstrated that robotic repair was associated with a decreased incidence of recurrence (2.1 versus 4.2%, p < 0.001) and surgical site occurrence (4.2 versus 18.8%, p < 0.001). This may be because robotic repair was associated with increased incidence of primary fascial closure (77.1 versus 66.7%, p < 0.01). Analysis of baseline patient populations showed that robotic repairs were completed on patients with lower body mass index (28.1 ± 3.6 versus 34.2 ± 6.4, p < 0.001) and fewer comorbidities. Our retrospective data show that robotic repair was associated with decreased recurrence and surgical site occurrence. However, the differences noted in the patient populations limit the interpretability of these results. As adoption of robotic ventral hernia repair increases, prospective trials need to be designed in order to investigate the efficacy, safety, and cost effectiveness of this evolving technique.

Technical tips during implantation of selective upper airway stimulation.

PubMed

Heiser, Clemens; Thaler, Erica; Soose, Ryan J; Woodson, B Tucker; Boon, Maurits

2018-03-01

Selective upper airway stimulation is now well-established in the United States and in several European countries, with more than 1,000 patients implanted since U.S. Food and Drug Administration approval in April 2014. The authors herein, all head and neck surgeons, account for approximately one of every five implants completed to date. Several of the authors also provide comprehensive longitudinal care of their patients as dual-specialty sleep medicine physicians. Multi-center, retrospective clinical analysis. More than 300 implants have been evaluated and reviewed in five different implant centers (Germany, United States). This analysis shares tips and techniques from the collective experiences with more than 300 implants, which can help newer implanters learn vicariously both for standard practices in executing routine implants through activation and, importantly, for working through more challenging encounters with anatomy, special patient phenotypes, system testing, and troubleshooting. These tips should help new implanters handle most of the situations arising during implantation and avoid common pitfalls. Laryngoscope, 128:756-762, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Prospective multi-center study of an automatic online seizure detection system for epilepsy monitoring units.

PubMed

Fürbass, F; Ossenblok, P; Hartmann, M; Perko, H; Skupch, A M; Lindinger, G; Elezi, L; Pataraia, E; Colon, A J; Baumgartner, C; Kluge, T

2015-06-01

A method for automatic detection of epileptic seizures in long-term scalp-EEG recordings called EpiScan will be presented. EpiScan is used as alarm device to notify medical staff of epilepsy monitoring units (EMUs) in case of a seizure. A prospective multi-center study was performed in three EMUs including 205 patients. A comparison between EpiScan and the Persyst seizure detector on the prospective data will be presented. In addition, the detection results of EpiScan on retrospective EEG data of 310 patients and the public available CHB-MIT dataset will be shown. A detection sensitivity of 81% was reached for unequivocal electrographic seizures with false alarm rate of only 7 per day. No statistical significant differences in the detection sensitivities could be found between the centers. The comparison to the Persyst seizure detector showed a lower false alarm rate of EpiScan but the difference was not of statistical significance. The automatic seizure detection method EpiScan showed high sensitivity and low false alarm rate in a prospective multi-center study on a large number of patients. The application as seizure alarm device in EMUs becomes feasible and will raise the efficiency of video-EEG monitoring and the safety levels of patients. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Differential diagnosis between tuberculous spondylodiscitis and pyogenic spontaneous spondylodiscitis: a multicenter descriptive and comparative study.

PubMed

Yoon, Young K; Jo, Yu M; Kwon, Hyun H; Yoon, Hee J; Lee, Eun J; Park, So Y; Park, Seong Y; Choo, Eun J; Ryu, Seong Y; Lee, Mi S; Yang, Kyung S; Kim, Shin W

2015-08-01

Although tuberculous and pyogenic spondylodiscitis are common causes of spinal infections, their protean manifestation complicates differential diagnosis. The clinical, laboratory, and radiologic characteristics of tuberculous and pyogenic spontaneous spondylodiscitis were compared in this study. This multicenter retrospective study was conducted in 11 teaching hospitals in the Republic of Korea from January 2011 to December 2013. Study subjects included adult patients (≥18 years) diagnosed with tuberculous (n=60) or pyogenic (n=117) spontaneous spondylodiscitis. Risk factors for tuberculous spondylodiscitis were determined, and their predictive performance was evaluated. Multivariate logistic regression analysis was performed to determine predictors independently associated with tuberculous spondylodiscitis. Receiver-operating characteristic curve analysis using the presence or absence of risk factors was used to generate a risk index to identify patients with increased probability of tuberculous spondylodiscitis. Of 177 patients, multivariate logistic regression analysis showed that patients with tuberculous spondylodiscitis (n=60) were more frequently women, with increased nonlumbar spinal involvement and associated non-spinal lesions, delayed diagnosis, higher serum albumin levels, reduced white blood cell counts, and lower C-reactive protein and procalcitonin levels. Among 117 patients with pyogenic spondylodiscitis, the most frequent causative microorganism was Staphylococcus aureus (64.1%). The mean diagnostic delay was significantly shorter, which may reflect higher clinical expression leading to earlier diagnosis. A combination of clinical data and biomarkers had better predictive value for differential diagnosis compared with biomarkers alone, with an area under the curve of 0.93, and sensitivity, specificity, and positive and negative predictive values of 95.0%, 79.5%, 70.4%, and 96.9%, respectively. This study provides guidance for clinicians to predict the causative organisms of spondylodiscitis in uncertain situations and before culture or pathologic examinations. Clinical data and single biomarkers combined can be useful for differential diagnoses between tuberculous and pyogenic spondylodiscitis. Copyright © 2015. Published by Elsevier Inc.

Cardiovascular risk in peritoneal dialysis - a Portuguese multicenter study.

PubMed

Neves, Marta; Machado, Susana; Rodrigues, Luís; Borges, Andreia; Maia, Pedro; Campos, Mário

2014-01-01

Cardiovascular (CV) disease is the major cause of mortality in patients undergoing renal replacement therapy. The primary aim of the study was to evaluate the CV risk profile and prevalence of CV disease in patients on peritoneal dialysis (PD) in Portugal. The secondary goal was to establish parameters most associated with CV disease. Retrospective, multicenter study of the prevalent adult population on PD. Six hundred patients were included (56.7% male; mean age 53.5 ± 15.3 years), on PD for 25.6 ± 21.9 months. Patients were divided into two groups: group 1 (n=166) with CV disease and group 2 (n=434) without CV disease. Comparisons were made regarding traditional CV risk factors and those associated with uremia and PD itself, and a multivariate analysis was performed to determine variables independently associated with CV disease. At the end of the study, the prevalence of CV disease was 28%. At univariate analysis, group 1 presented a higher frequency of males (p<.01), older patients (p<.01), diabetics (p<.01), occurrence of left ventricular hypertrophy (LVH) (p<.01), mean C-reactive protein (CRP) (p=.04), lower mean parathormone level (p=.014), lower serum phosphorus (p=.02), lower daily urine output (p=.04), lower weekly Kt/V (p=.008), increased use of icodextrin and hypertonic glucose-based PD solutions (p<.001 and p=.006, respectively) and more were under continuous ambulatory PD (CAPD) (p=.014) and had a high peritoneal transport status (p=.02). Multivariate analysis provided a significant discriminatory influence pertaining to age >50 years, CRP>0.6 mg/dl, male gender, diabetes, LVH, CAPD and anuria, when comparing group 1 and group 2. Risk factors most related to the development of CV disease in PD in Portugal are age >50 years, CRP>0.6 mg/dL, male gender, diabetes, LVH, CAPD and anuria.

Clinical evaluation of XaraColl(®), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies.

PubMed

Cusack, Susan L; Jaros, Mark; Kuss, Michael; Minkowitz, Harold S; Winkle, Peter; Hemsen, Lisa

2012-01-01

XaraColl(®), a collagen-based implant that delivers bupivacaine to the site of surgical trauma, is under development for postoperative analgesia. Because of differing patient attitudes to postoperative pain control and the inability to assess baseline pain, standard clinical methods for evaluating analgesic efficacy are compromised and justify application of novel integrated approaches. We conducted two independent, multicenter, double-blind, placebo-controlled studies in men undergoing unilateral inguinal hernioplasty by open laparotomy to evaluate the safety and efficacy of XaraColl at different doses (100 mg and 200 mg of bupivacaine hydrochloride; study 1 and 2, respectively). Enrolled patients (50 in study 1 and 53 in study 2) were randomized to receive active or placebo implants in a 1:1 ratio. Postoperative pain intensity and use of supplementary opioid medication were recorded through 72 hours. Safety was assessed through 30 days. The principal efficacy variables were the summed pain intensity (SPI), total use of opioid analgesia (TOpA), and an integrated endpoint (I-SPI-TOpA). Each variable was analyzed at 24, 48, and 72 hours after implantation. A pooled analysis of both studies was also performed retrospectively. Through 24 and 48 hours, XaraColl-treated patients experienced significantly less pain in study 1 (P < 0.001 and P = 0.012, respectively) whereas they took significantly less opioid analgesia in study 2 (P = 0.004 and P = 0.042, respectively). Over the same time intervals in the pooled analysis, treated patients experienced both significantly less pain (P < 0.001 and P = 0.006, respectively) and took significantly less opioid analgesia (P = 0.001 and P = 0.024, respectively). The I-SPI-TOpA endpoint that combined both SPI and TOpA demonstrated a significant treatment effect through 72 hours in the pooled analysis (P = 0.021). XaraColl offers great potential for improving the management of postoperative pain and warrants further investigation in definitive clinical trials.

Effectiveness and Safety of Vedolizumab in Anti-TNF-Naïve Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study.

PubMed

Kopylov, Uri; Verstockt, Bram; Biedermann, Luc; Sebastian, Shaji; Pugliese, Daniela; Sonnenberg, Elena; Steinhagen, Peter; Arebi, Naila; Ron, Yulia; Kucharzik, Torsten; Roblin, Xavier; Ungar, Bella; Shitrit, Ariella Bar-Gil; Ardizzone, Sandro; Molander, Pauliina; Coletta, Marina; Peyrin-Biroulet, Laurent; Bossuyt, Peter; Avni-Biron, Irit; Tsoukali, Emmanouela; Allocca, Mariangela; Katsanos, Konstantinos; Raine, Tim; Sipponen, Taina; Fiorino, Gionata; Ben-Horin, Shomron; Eliakim, Rami; Armuzzi, Alessandro; Siegmund, Britta; Baumgart, Daniel C; Kamperidis, Nikolaos; Maharshak, Nitsan; Maaser, Christian; Mantzaris, Gerassimos; Yanai, Henit; Christodoulou, Dimitrious K; Dotan, Iris; Ferrante, Marc

2018-05-18

Vedolizumab (VDZ) is effective for treatment of ulcerative colitis (UC) and Crohn's disease (CD). In GEMINI trials, anti-tumor necrosis factor (anti-TNF)-naïve patients had a superior response compared with anti-TNF-exposed patients. In real-world experience (RWE), the number of included anti-TNF-naïve patients was low. We aimed to evaluate the effectiveness and safety of VDZ in anti-TNF-naïve patients in an RWE setting. This retrospective multicenter European pooled cohort study included consecutive active anti-TNF-naïve IBD patients treated with VDZ. The primary end point was clinical response at week 14. Patients with follow-up beyond week 14 and those discontinuing VDZ at any time were included for maintenance outcomes analysis. Since January 2015, 184 anti-TNF-naïve patients from 23 centers initiated VDZ treatment (Crohn's disease [CD], 50; ulcerative colitis [UC], 134). In CD, 42/50 (82%) patients responded by week 14 and 32 (64%) were in clinical remission; 26/50 (52%) achieved corticosteroid-free remission (CSFR). At last follow-up (44 weeks; interquartile range [IQR], 30-52 weeks), 27/35 (77.1%) patients with available data responded to treatment; 24/35 (68.6%) were in clinical remission, 21/35 (60%) were in CSFR. For UC, 116/134 (79.1%) responded to treatment by week 14, including 53 (39.5%) in clinical remission; 49/134 (36.6%) achieved CSFR. At last follow-up (42.5 weeks; IQR, 30-52 weeks), 79/103 (76.7%) patients responded to treatment, 69/103 (67.0%) were in remission, and 61/103 (59.2%) were in CSFR. Adverse effects were reported in 20 (11%) of the patients, leading to treatment discontinuation in 6 (3.3%). VDZ is similarly effective in ant-TNF-naïve CD and UC patients. The efficacy is higher than reported in anti-TNF-experienced patients and is comparable to that of anti-TNF biologics in this population.

Association of day 4 cumulative fluid balance with mortality in critically ill patients with influenza: A multicenter retrospective cohort study in Taiwan

PubMed Central

Chien, Ying-Chun; Sheu, Chau-Chyun; Tsai, Ming-Ju; Fang, Wen-Feng; Chen, Yu-Mu; Kao, Kuo-Chin; Hu, Han-Chung; Perng, Wann-Cherng; Yang, Kuang-Yao; Chen, Wei-Chih; Liang, Shinn-Jye; Wu, Chieh-Liang; Wang, Hao-Chien; Chan, Ming-Cheng

2018-01-01

Background Fluid balance is a fundamental management of patients with sepsis, and this study aimed to investigate the impact of cumulative fluid balance on critically ill patients with influenza admitted to an intensive care unit (ICU). Methods This multicenter retrospective cohort study was conducted by the Taiwan Severe Influenza Research Consortium (TSIRC) which includes eight medical centers. Patients with virology-proven influenza infection admitted to ICUs between October 2015 and March 2016 were included for analysis. Results A total of 296 patients were enrolled (mean age: 61.4±15.6 years; 62.8% men), and 92.2% (273/296) of them required mechanical ventilation. In the survivors, the daily fluid balance was positive from day 1 to day 3, and then gradually became negative from day 4 to day 7, whereas daily fluid balance was continuously positive in the non-survivors. Using the cumulative fluid balance from day 1–4 as a cut-off point, we found that a negative cumulative day 1–4 fluid balance was associated with a lower 30-day mortality rate (log-rank test, P = 0.003). To evaluate the impact of shock on this association, we divided the patients into shock and non-shock groups. The positive correlation between negative day 1–4 fluid balance and mortality was significant in the non-shock group (log-rank test, P = 0.008), but not in the shock group (log-rank test, P = 0.396). In a multivariate Cox proportional hazard regression model adjusted for age, sex, cerebrovascular disease, and PaO2/FiO2, day 1–4 fluid balance was independently associated with a higher 30-day mortality rate (aHR 1.088, 95% CI: 1.007–1.174). Conclusions A negative day 1–4 cumulative fluid balance was associated with a lower mortality rate in critically ill patients with influenza. Our findings indicate the critical role of conservative fluid strategy in the management of patients with complicated influenza. PMID:29315320

Tumors masquerading in patients with thyroid eye disease.

PubMed

Griepentrog, Gregory J; Burkat, Cat N; Kikkawa, Don O; Lucarelli, Mark J

2013-08-01

Thyroid eye disease (TED) is the most common cause of proptosis in adults. The external manifestations of TED are characteristic and the diagnosis is typically made without imaging. Although there are multiple descriptions of primary and secondary orbital tumors initially mistaken for TED in the literature, there are limited reports detailing the findings of patients with long-standing TED whom developed an orbital tumor at a later date. Herein, we present a 6-year retrospective multi-center report of three patients with long-standing TED who developed an initially unsuspected orbital or cavernous sinus tumor.

Performance of FDG-PET/CT in solitary pulmonary nodule based on pre-test likelihood of malignancy: results from the ITALIAN retrospective multicenter trial.

PubMed

Evangelista, Laura; Cuocolo, Alberto; Pace, Leonardo; Mansi, Luigi; Del Vecchio, Silvana; Miletto, Paolo; Sanfilippo, Silvia; Pellegrino, Sara; Guerra, Luca; Pepe, Giovanna; Peluso, Giuseppina; Salvatore, Marco; Galicchio, Rosj; Zuffante, Michele; Annunziata, Salvatore; Farsad, Mohsen; Chiaravalloti, Agostino; Spadafora, Marco

2018-05-07

The aim of this study was to determine the performance of 18 F-FDG-PET/CT in patients with solitary pulmonary nodule (SPN), stratifying the risk according to the likelihood of pulmonary malignancy. FDG-PET/CT of 502 patients, stratified for pre-test cancer risk, were retrospectively analyzed. FDG uptake in SPN was assessed by a 4-point scoring system and semiquantitative analysis using the ratio between SUVmax in SPN and SUVmean in mediastinal blood pool (BP) and between SUVmax in SPN and SUVmean in liver (L). Histopathology and/or follow-up data were used as standard of reference. SPN was malignant in 180 (36%) patients, benign in 175 (35%), and indeterminate in 147 (29%). The 355 patients with a definitive SPN nature (malignant or benign) were considered for the analysis. Considering FDG uptake ≥ 2, sensitivity, specificity, positive (PPV) and negative (NPV) predictive values, and accuracy were 85.6%, 85.7%, 86%, 85.2%, and 85.6% respectively. Sensitivity and PPV were higher (P < 0.05) in intermediate and high-risk patients, while specificity and NPV were higher (P < 0.05) in low-risk patients. On receiver operating characteristic curve analysis, the cut-offs for better discrimination between benign and malignant SPN were 1.56 (sensitivity 81% and specificity 87%) and 1.12 (sensitivity 81% and specificity 86%) for SUVmax/SUVmeanBP and SUVmax/SUVmeanL respectively. In intermediate and high-risk patients, including the SUVmax/SUVmeanBP, the specificity shifted from 85% and 50% to 100%. Visual FDG-PET/CT has an acceptable performance in patients with SPN, but accuracy improves when SUVratios are considered, particularly in patients with intermediate and high risk of malignancy.

Medical expenditure for liver cancer in urban China: A 10-year multicenter retrospective survey (2002-2011).

PubMed

Qiu, Wu-Qi; Shi, Ju-Fang; Guo, Lan-Wei; Mao, A-Yan; Huang, Hui-Yao; Hu, Guang-Yu; Dong, Pei; Bai, Fang-Zhou; Yan, Xiao-Ling; Liao, Xian-Zhen; Liu, Guo-Xiang; Bai, Ya-Na; Ren, Jian-Song; Sun, Xiao-Jie; Zhu, Xin-Yu; Zhou, Jin-Yi; Gong, Ji-Yong; Zhu, Lin; Mai, Ling; Du, Ling-Bing; Zhou, Qi; Xing, Xiao-Jing; Song, Bing-Bing; Liu, Yu-Qin; Lou, Pei-An; Sun, Xiao-Hua; Wu, Shou-Ling; Cao, Rong; Qi, Xiao; Lan, Li; Ren, Ying; Zhang, Kai; He, Jie; Qu, Chunfeng; Dai, Min

2018-01-01

This study aims to understand the medical expenditure for liver cancer during 2002-2011 in urban areas of China. This is a retrospective study. Based on a stratified cluster sampling method, a medical expenditure survey collected basic personal information from related medical records. Two-tailed independent sample t-test, variance analysis, and Student-Newman-Keuls Tests were used in cost analysis for the corresponding data types. A total of 12,342 liver cancer patients were included in the analysis. Overall average medical expenditure per case for liver cancer diagnosis and treatment in China has increased from ¥21, 950 to ¥40, 386 over the study period. For each liver cancer patient diagnosed between 2009 and 2011, the average expenditures were 29,332 CNY for stage I, 35,754 CNY for stage II, 34,288 CNY for stage III, and 30,275 CNY for stage IV diseases (P < 0.001). Pharmaceuticals accounted for the biggest part of the medical expenditure and it rose from 48.01% to 52.96% during these ten years, and the share of nursing fee expenses was the lowest (around 1%). Over the entire 10-year data period, the per capita expenditure of the east region (32,983 CNY) was higher than that of the west region (26,219 CNY) and slightly higher than the central region (31,018 CNY, P < 0.001). As a major cancer in China, liver cancer accounts for a large portion of health economic burden and its medical expenditure is heavy for families. Early diagnosis and treatment for liver cancer will save medical expenditure. The economic burden of liver cancer is high in China and related medical expenditure has increased.

A new prognostic model identifies patients aged 80 years and older with diffuse large B-cell lymphoma who may benefit from curative treatment: A multicenter, retrospective analysis by the Spanish GELTAMO group.

PubMed

Pardal, Emilia; Díez Baeza, Eva; Salas, Queralt; García, Tomás; Sancho, Juan M; Monzón, Encarna; Moraleda, José M; Córdoba, Raúl; de la Cruz, Fátima; Queizán, José A; Rodríguez, María J; Navarro, Belén; Hernández, José A; Díez, Rosana; Vahi, María; Viguria, María C; Canales, Miguel; Peñarrubia, María J; González-López, Tomás J; Montes-Moreno, Santiago; González-Barca, Eva; Caballero, Dolores; Martín, Alejandro

2018-04-15

The means of optimally managing very elderly patients with diffuse large B-cell lymphoma (DLBCL) has not been established. We retrospectively analyzed 252 patients aged 80-100 years, diagnosed with DLBCL or grade 3B follicular lymphoma, treated in 19 hospitals from the GELTAMO group. Primary objective was to analyze the influence of the type of treatment and comorbidity scales on progression-free survival (PFS) and overall survival (OS). One hundred sixty-three patients (63%) were treated with chemotherapy that included anthracyclines and/or rituximab, whereas 15% received no chemotherapeutic treatment. With a median follow-up of 44 months, median PFS and OS were 9.5 and 12.5 months, respectively. In an analysis restricted to the 205 patients treated with any kind of chemotherapy, comorbidity scales did not influence the choice of treatment type significantly. Independent factors associated with better PFS and OS were: age < 86 years, cumulative illness rating scale (CIRS) score < 6, intermediate risk (1-2) R-IPI, and treatment with R-CHOP at full or reduced doses. We developed a prognostic model based on the multivariate analysis of the 108 patients treated with R-CHOP-like: median OS was 45 vs. 12 months (P = .001), respectively, for patients with 0-1 vs. 2-3 risk factors (age > 85 years, R-IPI 3-5 or CIRS > 5). In conclusion, treatment with R-CHOP-like is associated with good survival in a significant proportion of patients. We have developed a simple prognostic model that may aid the selection patients who could benefit from a curative treatment, although it needs to be validated in larger series. © 2018 Wiley Periodicals, Inc.

A multicenter study shows PTEN deletion is strongly associated with seminal vesicle involvement and extracapsular extension in localized prostate cancer.

PubMed

Troyer, Dean A; Jamaspishvili, Tamara; Wei, Wei; Feng, Ziding; Good, Jennifer; Hawley, Sarah; Fazli, Ladan; McKenney, Jesse K; Simko, Jeff; Hurtado-Coll, Antonio; Carroll, Peter R; Gleave, Martin; Lance, Raymond; Lin, Daniel W; Nelson, Peter S; Thompson, Ian M; True, Lawrence D; Brooks, James D; Squire, Jeremy A

2015-08-01

Loss of the phosphatase and tensin homolog (PTEN) tumor suppressor gene is a promising marker of aggressive prostate cancer. Active surveillance and watchful waiting are increasingly recommended to patients with small tumors felt to be low risk, highlighting the difficulties of Gleason scoring in this setting. There is an urgent need for predictive biomarkers that can be rapidly deployed to aid in clinical decision-making. Our objectives were to assess the incidence and ability of PTEN alterations to predict aggressive disease in a multicenter study. We used recently developed probes optimized for sensitivity and specificity in a four-color FISH deletion assay to study the Canary Retrospective multicenter Prostate Cancer Tissue Microarray (TMA). This TMA was constructed specifically for biomarker validation from radical prostatectomy specimens, and is accompanied by detailed clinical information with long-term follow-up. In 612 prostate cancers, the overall rate of PTEN deletion was 112 (18.3%). Hemizygous PTEN losses were present in 55/612 (9.0%) of cancers, whereas homozygous PTEN deletion was observed in 57/612 (9.3%) of tumors. Significant associations were found between PTEN status and pathologic stage (P < 0.0001), seminal vesicle invasion (P = 0.0008), extracapsular extension (P < 0.0001), and Gleason score (P = 0.0002). In logistic regression analysis of clinical and pathological variables, PTEN deletion was significantly associated with extracapsular extension, seminal vesicle involvement, and higher Gleason score. In the 406 patients in which clinical information was available, PTEN homozygous (P = 0.009) deletion was associated with worse post-operative recurrence-free survival (number of events = 189), pre-operative prostate specific antigen (PSA) (P < 0.001), and pathologic stage (P = 0.03). PTEN status assessed by FISH is an independent predictor for recurrence-free survival in multivariate models, as were seminal vesicle invasion, extracapsular extension, and Gleason score, and preoperative PSA. Furthermore, these data demonstrate that the assay can be readily introduced at first diagnosis in a cost effective manner analogous to the use of FISH for analysis of HER2/neu status in breast cancer. Combined with published research beginning 17 years ago, both the data and tools now exist to implement a PTEN assay in the clinic. © 2015 The Authors. The Prostate, published by Wiley Periodicals, Inc.

Impact of Infliximab and Cyclosporine on the Risk of Colectomy in Hospitalized Patients with Ulcerative Colitis Complicated by Cytomegalovirus-A Multicenter Retrospective Study.

PubMed

Kopylov, Uri; Papamichael, Konstantinos; Katsanos, Konstantinos; Waterman, Matti; Bar-Gil Shitrit, Ariella; Boysen, Trine; Portela, Francisco; Peixoto, Armando; Szilagyi, Andrew; Silva, Marco; Maconi, Giovanni; Har-Noy, Ofir; Bossuyt, Peter; Mantzaris, Gerassimos; Barreiro de Acosta, Manuel; Chaparro, Maria; Christodoulou, Dimitrios K; Eliakim, Rami; Rahier, Jean-Francois; Magro, Fernando; Drobne, David; Ferrante, Marc; Sonnenberg, Elena; Siegmund, Britte; Muls, Vinciane; Thurm, Tamara; Yanai, Henit; Dotan, Iris; Raine, Tim; Levin, Avi; Israeli, Eran; Ghalim, Fahd; Carbonnel, Franck; Vermeire, Severine; Ben-Horin, Shomron; Roblin, Xavier

2017-09-01

Cytomegalovirus (CMV) is frequently detected in patients with ulcerative colitis (UC). The impact of CMV infection on the outcome of UC exacerbation remains unclear. The benefit of combining antiviral with anti-inflammatory treatment has not been evaluated yet. The aim of this study was to compare the outcome of CMV-positive hospitalized patients with UC treated with antiviral therapy either alone or combined with salvage anti-inflammatory therapy (infliximab [IFX] or cyclosporine A [CsA]). This was a multicenter retrospective study of hospitalized CMV-positive patients with UC. The patients were classified into 2 groups: antiviral-if treated with antivirals alone; combined-if treated with both antiviral and anti-inflammatory therapy. The outcomes included the rate of colectomy in both arms during the course of hospitalization and after 3/12 months. A total of 110 patients were included; 47 (42.7%) patients did not receive IFX nor CsA; 36 (32.7%) received IFX during hospitalization or within 1 month before hospitalization; 20 (18.1%) patients received CsA during hospitalization; 7 (6.4%) were exposed to both IFX and CsA. The rate of colectomy was 14.5% at 30 days, 20.0% at 3 months, and 34.8% at 12 months. Colectomy rates were similar across treatment groups. No clinical and demographic variables were independently associated with the risk of colectomy. IFX or cyclosporine therapy is not associated with additional risk for colectomy over antiviral therapy alone in hospitalized CMV-positive patients with UC.

Radiological Insertion of Denver Peritoneovenous Shunts for Malignant Refractory Ascites: A Retrospective Multicenter Study (JIVROSG-0809)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sugawara, Shunsuke, E-mail: suga_shun@hotmail.com; Sone, Miyuki; Arai, Yasuaki

Purpose: Peritoneal venous shunts (PVSs) are widely used for palliating symptoms of refractory malignant ascites and are recognized as one of the practical methods. However, reliable clinical data are insufficient because most previous reports have been small studies from single centers. We conducted a retrospective, multicenter study to evaluate the safety and efficacy of radiologically placed PVSs in patients with malignant refractory ascites. Methods: A total of 133 patients with malignant ascites refractory to medical therapies were evaluated for patient characteristics, technical success, efficacy, survival times, adverse events, and changes in laboratory data. Results: PVSs were successfully placed in allmore » patients and were effective (i.e., improvement of ascites symptoms lasting 7 days or more) in 110 (82.7%). The median duration of symptom palliation was 26 days and median survival time was 41 days. The most frequent adverse event was PVS dysfunction, which occurred in 60 (45.1%) patients, among whom function was recovered with an additional minimally invasive procedure in 9. Abnormalities in coagulation (subclinical disseminated intravascular coagulation) occurred in 37 (27.8%) patients, although only 7 (5.3%) developed clinical disseminated intravascular coagulation. Other major adverse events were gastrointestinal bleeding (9.8%), sepsis (3.8%), and acute heart failure (3.0%). PVS was least effective in patients with elevated serum creatinine, bloody ascites, or gynecologic tumor. Conclusions: Radiological PVS is a technically feasible and effective method for palliating the symptoms from refractory malignant ascites, but preoperative evaluation and monitoring the postprocedural complications are mandatory to preclude severe adverse events after PVS.« less

Roux-en-Y Gastric Bypass vs. Sleeve Gastrectomy vs. Gastric Banding: The First Multicenter Retrospective Comparative Cohort Study in Obese Korean Patients.

PubMed

Lee, Sang Kuon; Heo, Yoonseok; Park, Joong Min; Kim, Yong Jin; Kim, Seong Min; Park, Do Joong; Han, Sang Moon; Shim, Kyung Won; Lee, Yeon Ji; Lee, Ja Youn; Kwon, Jin Won

2016-07-01

Bariatric surgery is relatively new in Korea, and studies comparing different bariatric procedures in Koreans are lacking. This study aimed to compare the clinical outcomes of laparoscopic adjustable gastric banding (LAGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG) for treating morbidly obese Korean adults. In this multicenter retrospective cohort study, we reviewed the medical records of 261 obese patients who underwent different bariatric procedures. Clinical outcomes were measured in terms of weight loss and resolution of comorbidities, such as diabetes, hypertension, and dyslipidemia. Safety profiles for the procedures were also evaluated. In terms of weight loss, the three procedures showed similar results at 18 months (weight loss in 52.1% for SG, 61.0% for LAGB, and 69.2% for RYGB). Remission of diabetes, hypertension, and dyslipidemia was more frequent in patients who underwent RYGB (65.9%, 63.6%, and 100% of patients, respectively). Safety profiles were similar among groups. Early complications occurred in 26 patients (9.9%) and late complications in 32 (12.3%). In the LAGB group, five bands (6.9%) were removed. Among all patients, one death (1/261=0.38%) occurred in the RYGB group due to aspiration pneumonia. The three bariatric procedures were comparable in regards to weight-loss outcomes; nevertheless, RYGB showed a higher rate of comorbidity resolution. Bariatric surgery is effective and relatively safe; however, due to complications, some bands had to be removed in the LAGB group and a relatively high rate of reoperations was observed in the RYGB group.

Trends in childhood type 1 diabetes mellitus incidence in Beijing from 1995 to 2010: a retrospective multicenter study based on hospitalization data.

PubMed

Gong, Chunxiu; Meng, Xi; Jiang, Yuwu; Wang, Xinli; Cui, Hong; Chen, Xiaobo

2015-03-01

The incidence of type 1 diabetes mellitus (T1DM) is increasing rapidly worldwide for children of every age group. A retrospective analysis of hospital registration data from five tertiary hospitals in Beijing, China, identified 485 patients (210 boys, 275 girls) younger than 15 years of age with newly diagnosed T1DM between 1995 and 2010. From 1995 to 2010, the incidence of T1DM in patients <15 years of age ranged from 0.935-3.26 per 100,000 per year. During this period, the average age-standardized incidence rate was 1.7 per 100,000 per year, and the average annual increase in T1DM incidence was 4.36%. The highest rate increases occurred in boys and in patients <5 years of age. For both genders and all age groups, T1DM incidence increased at an accelerated rate after 2006. By 2020, the incidence of T1DM among children in Beijing is projected to increase by a factor of 1.69. The incidence of T1DM among patients younger than 15 years of age in Beijing increased from 1995 to 2010, with rates growing at an accelerated pace since 2006. Based on recent trends, we project continued rapid growth in the number of new childhood T1DM cases in Beijing.

Low incidence but poor prognosis of complicated coeliac disease: a retrospective multicentre study.

PubMed

Biagi, Federico; Gobbi, Paolo; Marchese, Alessandra; Borsotti, Edoardo; Zingone, Fabiana; Ciacci, Carolina; Volta, Umberto; Caio, Giacomo; Carroccio, Antonio; Ambrosiano, Giuseppe; Mansueto, Pasquale; Corazza, Gino R

2014-03-01

Coeliac disease is a chronic enteropathy characterized by an increased mortality caused by its complications, mainly refractory coeliac disease, small bowel carcinoma and abdominal lymphoma. Aim of the study was to study the epidemiology of complications in patients with coeliac disease. Retrospective multicenter case-control study based on collection of clinical and laboratory data. The incidence of complicated coeliac disease was studied among coeliac patients directly diagnosed in four Italian centres. Patients referred to these centres after a diagnosis of coeliac disease and/or complicated coeliac disease in other hospitals were therefore excluded. Between 1/1999 and 10/2011, 1840 adult coeliac patients were followed up for 7364.3 person-years. Fourteen developed complications. Since five patients died, at the end of the observation period (10/2011), the prevalence of complicated coeliac disease was 9/1835 (1/204, 0.49%, 95% CI 0.2-0.9%). The annual incidence of complicated coeliac disease in the study period was 14/7364 (0.2%, 95% CI 0.1-0.31%). Although complications tend to occur soon after the diagnosis of coeliac disease, Kaplan-Meier curve analysis showed that they can actually occur at any time after the diagnosis of coeliac disease. Complications of coeliac disease in our cohort were quite rare, though characterised by a very high mortality. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

AB0 blood groups and rhesus factor expression as prognostic parameters in patients with epithelial ovarian cancer - a retrospective multi-centre study.

PubMed

Seebacher, Veronika; Polterauer, Stephan; Reinthaller, Alexander; Koelbl, Heinz; Achleitner, Regina; Berger, Astrid; Concin, Nicole

2018-04-19

AB0 blood groups and Rhesus factor expression have been associated with carcinogenesis, response to treatment and tumor progression in several malignancies. The aim of the present study was to test the hypothesis that AB0 blood groups and Rhesus factor expression are associated with clinical outcome in patients with epithelial ovarian cancer (EOC). AB0 blood groups and Rhesus factor expression were evaluated in a retrospective multicenter study including 518 patients with EOC. Their association with patients' survival was assessed using univariate and multivariable analyses. Neither AB0 blood groups nor Rhesus factor expression were associated with clinico-pathological parameters, recurrence-free, cancer-specific, or overall survival. In a subgroup of patients with high-grade serous adenocarcinoma, however, blood groups B and AB were associated with a better 5-year cancer-specific survival rate compared to blood groups A and 0 (60.3 ± 8.6% vs. 43.8 ± 3.6%, p = 0.04). Yet, this was not significant in multivariable analysis. AB0 blood groups and Rhesus factor expression are both neither associated with features of biologically aggressive disease nor clinical outcome in patients with EOC. Further investigation of the role of the blood group B antigen on cancer-specific survival in the subgroup of high-grade serous should be considered.

A multicenter retrospective analysis of the clinical features of pernicious anemia in a Korean population.

PubMed

Song, Ik-Chan; Lee, Hyo Jin; Kim, Han-Jo; Bae, Sang-Byung; Lee, Kyu-Taek; Yang, Young-Jun; Park, Suk-Young; Cho, Do-Yeun; Kim, Nae Yu; Cho, In-Sung; Jo, Deog-Yeon

2013-02-01

To determine the approximate incidence and clinical features of pernicious anemia in a Korean population, we retrospectively analyzed clinical data for patients with pernicious anemia who were diagnosed between 1995 and 2010 at five hospitals in Chungnam province. Ninety-seven patients were enrolled, who accounted for 24% of patients with vitamin B(12) deficiency anemia. The approximate annual incidence of pernicious anemia was 0.3 per 100,000. The median age was 66 (range, 32-98) yr, and the male/female ratio was 1.25. Anemia-associated discomfort was the most common symptom (79.4%), followed by gastrointestinal and neurological symptoms (78.4% and 38.1%, respectively). Pancytopenia was found in 36 patients (37.1%), and autoimmune disorders were found in 15 patients (15.5%). Antibody to intrinsic factor was detected in 62 (77.5%) of 80 patients examined, and antibody to parietal cells was detected in 35 (43.2%) of 81 patients examined. Of the 34 patients who underwent tests for Helicobacter pylori, 7 (12.5%) were positive. The anemia-associated and gastrointestinal symptoms resolved completely in all patients after intramuscular injection of cobalamin, whereas neurological symptoms remained in some. In conclusion, pernicious anemia is less frequent in Koreans than in Western populations; however, the clinical features of this disorder in Koreans do not differ from those of Western cases.

A Multicenter Retrospective Analysis of the Clinical Features of Pernicious Anemia in a Korean Population

PubMed Central

Song, Ik-Chan; Lee, Hyo Jin; Kim, Han-Jo; Bae, Sang-Byung; Lee, Kyu-Taek; Yang, Young-Jun; Park, Suk-Young; Cho, Do-Yeun; Kim, Nae Yu; Cho, In-Sung

2013-01-01

To determine the approximate incidence and clinical features of pernicious anemia in a Korean population, we retrospectively analyzed clinical data for patients with pernicious anemia who were diagnosed between 1995 and 2010 at five hospitals in Chungnam province. Ninety-seven patients were enrolled, who accounted for 24% of patients with vitamin B12 deficiency anemia. The approximate annual incidence of pernicious anemia was 0.3 per 100,000. The median age was 66 (range, 32-98) yr, and the male/female ratio was 1.25. Anemia-associated discomfort was the most common symptom (79.4%), followed by gastrointestinal and neurological symptoms (78.4% and 38.1%, respectively). Pancytopenia was found in 36 patients (37.1%), and autoimmune disorders were found in 15 patients (15.5%). Antibody to intrinsic factor was detected in 62 (77.5%) of 80 patients examined, and antibody to parietal cells was detected in 35 (43.2%) of 81 patients examined. Of the 34 patients who underwent tests for Helicobacter pylori, 7 (12.5%) were positive. The anemia-associated and gastrointestinal symptoms resolved completely in all patients after intramuscular injection of cobalamin, whereas neurological symptoms remained in some. In conclusion, pernicious anemia is less frequent in Koreans than in Western populations; however, the clinical features of this disorder in Koreans do not differ from those of Western cases. PMID:23400269

Cantharides poisoning: A retrospective analysis from 1996 to 2016 in China.

PubMed

Zhang, Youyou; Zhou, Xiaowei; Zhang, Jie; Guan, Chuhuai; Liu, Liang

2018-05-10

Cantharides poisoning may cause serious adverse reactions or even death.We attempt to retrieval articles automatically and manually with the key words of "cantharides" and " poisoning " or " side effects ", then summarized and analyzed the cases of cantharides poisoning from 1996 to 2016 in China, to provide some reference for clinical drug use and forensic identification. Finally, 91 cases were conformance to require; general data, clinical data, prognosis, autopsy results were analyzed.We found that the health education of cantharides in primary doctors and people is lackable, the case fatality rate was 18.68% . The death patients of cantharides poisoning had cardiomyocyte necrosis and neuronal apoptosis in the histopathological examination of autopsy , but the toxicological mechanism was unclear. There may be redistribution of cantharidin in vivo after death. Collectively, we hope that an anthropological database for cantharides poisoning established by multicenter cooperation, include medical institutions and forensic identified centers, and conduct more further studies on its cardiotoxicity and neurotoxicity. Copyright © 2018. Published by Elsevier Inc.

Development and Validation of an Abbreviated Questionnaire to Easily Measure Cognitive Failure in ICU Survivors: A Multicenter Study.

PubMed

Wassenaar, Annelies; de Reus, Jorn; Donders, A Rogier T; Schoonhoven, Lisette; Cremer, Olaf L; de Lange, Dylan W; van Dijk, Diederik; Slooter, Arjen J C; Pickkers, Peter; van den Boogaard, Mark

2018-01-01

To develop and validate an abbreviated version of the Cognitive Failure Questionnaire that can be used by patients as part of self-assessment to measure functional cognitive outcome in ICU survivors. A retrospective multicenter observational study. The ICUs of two Dutch university hospitals. Adult ICU survivors. None. Cognitive functioning was evaluated between 12 and 24 months after ICU discharge using the full 25-item Cognitive Failure Questionnaire (CFQ-25). Incomplete CFQ-25 questionnaires were excluded from analysis. Forward selection in a linear regression model was used in hospital A to assess which of the CFQ-25 items should be included to prevent a significant loss of correlation between an abbreviated and the full CFQ-25. Subsequently, the performance of an abbreviated Cognitive Failure Questionnaire was determined in hospital B using Pearson's correlation. A Bland-Altman plot was used to examine whether the reduced-item outcome scores of an abbreviated Cognitive Failure Questionnaire were a replacement for the full CFQ-25 outcome scores. Among 1,934 ICU survivors, 1,737 were included, 819 in hospital A, 918 in hospital B. The Pearson's correlation between the abbreviated 14-item Cognitive Failure Questionnaire (CFQ-14) and the CFQ-25 was 0.99. The mean of the difference scores was -0.26, and 95% of the difference scores fell within +5 and -5.5 on a 100-point maximum score. It is feasible to use the abbreviated CFQ-14 to measure self-reported cognitive failure in ICU survivors as this questionnaire has a similar performance as the full CFQ-25.

A multicenter study of routine versus selective intraoperative leak testing for sleeve gastrectomy.

PubMed

Bingham, Jason; Kaufman, Jedediah; Hata, Kai; Dickerson, James; Beekley, Alec; Wisbach, Gordon; Swann, Jacob; Ahnfeldt, Eric; Hawkins, Devon; Choi, Yong; Lim, Robert; Martin, Matthew

2017-09-01

Staple line leaks after sleeve gastrectomy are dreaded complications. Many surgeons routinely perform an intraoperative leak test (IOLT) despite little evidence to validate the reliability, clinical benefit, and safety of this procedure. To determine the efficacy of IOLT and if routine use has any benefit over selective use. Eight teaching hospitals, including private, university, and military facilities. A multicenter, retrospective analysis over a 5-year period. The efficacy of the IOLT for identifying unsuspected staple line defects and for predicting postoperative leaks was evaluated. An anonymous survey was also collected reflecting surgeons' practices and beliefs regarding IOLT. From January 2010 through December 2014, 4284 patients underwent sleeve gastrectomy. Of these, 37 patients (.9%) developed a postoperative leak, and 2376 patients (55%) received an IOLT. Only 2 patients (0.08%) had a positive finding. Subsequently, 21 patients with a negative IOLT developed a leak. IOLT demonstrated a sensitivity of only 8.7%. There was a nonsignificant trend toward increased leak rates when an IOLT was performed versus when IOLT was not performed. Leak rates were not statistically different between centers that routinely perform IOLT versus those that selectively perform IOLT. Routine IOLT had very poor sensitivity and was negative in 91% of patients who later developed postoperative leaks. The use of IOLT was not associated with a decrease in the incidence of postoperative leaks, and routine IOLT had no benefit over selective leak testing. IOLT should not be used as a quality indicator or "best practice" for bariatric surgery. Published by Elsevier Inc.

Endovascular treatment of mycotic aortic aneurysms: a European multicenter study.

PubMed

Sörelius, Karl; Mani, Kevin; Björck, Martin; Sedivy, Petr; Wahlgren, Carl-Magnus; Taylor, Peter; Clough, Rachel E; Lyons, Oliver; Thompson, Matt; Brownrigg, Jack; Ivancev, Krassi; Davis, Meryl; Jenkins, Michael P; Jaffer, Usman; Bown, Matt; Rancic, Zoran; Mayer, Dieter; Brunkwall, Jan; Gawenda, Michael; Kölbel, Tilo; Jean-Baptiste, Elixène; Moll, Frans; Berger, Paul; Liapis, Christos D; Moulakakis, Konstantinos G; Langenskiöld, Marcus; Roos, Håkan; Larzon, Thomas; Pirouzram, Artai; Wanhainen, Anders

2014-12-09

Mycotic aortic aneurysm (MAA) is a rare and life-threatening disease. The aim of this European multicenter collaboration was to study the durability of endovascular aortic repair (EVAR) of MAA, by assessing late infection-related complications and long-term survival. All EVAR treated MAAs, between 1999 and 2013 at 16 European centers, were retrospectively reviewed. One hundred twenty-three patients with 130 MAAs were identified. Mean age was 69 years (range 39-86), 87 (71%) were men, 58 (47%) had immunodeficiency, and 47 (38%) presented with rupture. Anatomic locations were ascending/arch (n=4), descending (n=34), paravisceral (n=15), infrarenal aorta (n=63), and multiple (n=7). Treatments were thoracic EVAR (n=43), fenestrated/branched EVAR (n=9), and infrarenal EVAR (n=71). Antibiotic was administered for mean 30 weeks. Mean follow-up was 35 months (range 1 week to 149 months). Six patients (5%) were converted to open repair during follow-up. Survival was 91% (95% confidence interval, 86% to 96%), 75% (67% to 83%), 55% (44% to 66%), and 41% (28% to 54%) after 1, 12, 60, and 120 months, respectively. Infection-related death occurred in 23 patients (19%), 9 after discontinuation of antibiotic treatment. A Cox regression analysis demonstrated non-Salmonella-positive culture as predictors for late infection-related death. Endovascular treatment of MAA is feasible and for most patients a durable treatment option. Late infections do occur, are often lethal, and warrant long-term antibiotic treatment and follow-up. Patients with non-Salmonella-positive blood cultures were more likely to die from late infection. © 2014 American Heart Association, Inc.

Many multicenter trials had few events per center, requiring analysis via random-effects models or GEEs.

PubMed

Kahan, Brennan C; Harhay, Michael O

2015-12-01

Adjustment for center in multicenter trials is recommended when there are between-center differences or when randomization has been stratified by center. However, common methods of analysis (such as fixed-effects, Mantel-Haenszel, or stratified Cox models) often require a large number of patients or events per center to perform well. We reviewed 206 multicenter randomized trials published in four general medical journals to assess the average number of patients and events per center and determine whether appropriate methods of analysis were used in trials with few patients or events per center. The median number of events per center/treatment arm combination for trials using a binary or survival outcome was 3 (interquartile range, 1-10). Sixteen percent of trials had less than 1 event per center/treatment combination, 50% fewer than 3, and 63% fewer than 5. Of the trials which adjusted for center using a method of analysis which requires a large number of events per center, 6% had less than 1 event per center-treatment combination, 25% fewer than 3, and 50% fewer than 5. Methods of analysis that allow for few events per center, such as random-effects models or generalized estimating equations (GEEs), were rarely used. Many multicenter trials contain few events per center. Adjustment for center using random-effects models or GEE with model-based (non-robust) standard errors may be beneficial in these scenarios. Copyright © 2015 Elsevier Inc. All rights reserved.

A novel strategy to translate the biomechanical rupture risk of abdominal aortic aneurysms to their equivalent diameter risk: method and retrospective validation.

PubMed

Gasser, T C; Nchimi, A; Swedenborg, J; Roy, J; Sakalihasan, N; Böckler, D; Hyhlik-Dürr, A

2014-03-01

To translate the individual abdominal aortic aneurysm (AAA) patient's biomechanical rupture risk profile to risk-equivalent diameters, and to retrospectively test their predictability in ruptured and non-ruptured aneurysms. Biomechanical parameters of ruptured and non-ruptured AAAs were retrospectively evaluated in a multicenter study. General patient data and high resolution computer tomography angiography (CTA) images from 203 non-ruptured and 40 ruptured aneurysmal infrarenal aortas. Three-dimensional AAA geometries were semi-automatically derived from CTA images. Finite element (FE) models were used to predict peak wall stress (PWS) and peak wall rupture index (PWRI) according to the individual anatomy, gender, blood pressure, intra-luminal thrombus (ILT) morphology, and relative aneurysm expansion. Average PWS diameter and PWRI diameter responses were evaluated, which allowed for the PWS equivalent and PWRI equivalent diameters for any individual aneurysm to be defined. PWS increased linearly and PWRI exponentially with respect to maximum AAA diameter. A size-adjusted analysis showed that PWS equivalent and PWRI equivalent diameters were increased by 7.5 mm (p = .013) and 14.0 mm (p < .001) in ruptured cases when compared to non-ruptured controls, respectively. In non-ruptured cases the PWRI equivalent diameters were increased by 13.2 mm (p < .001) in females when compared with males. Biomechanical parameters like PWS and PWRI allow for a highly individualized analysis by integrating factors that influence the risk of AAA rupture like geometry (degree of asymmetry, ILT morphology, etc.) and patient characteristics (gender, family history, blood pressure, etc.). PWRI and the reported annual risk of rupture increase similarly with the diameter. PWRI equivalent diameter expresses the PWRI through the diameter of the average AAA that has the same PWRI, i.e. is at the same biomechanical risk of rupture. Consequently, PWRI equivalent diameter facilitates a straightforward interpretation of biomechanical analysis and connects to diameter-based guidelines for AAA repair indication. PWRI equivalent diameter reflects an additional diagnostic parameter that may provide more accurate clinical data for AAA repair indication. Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Efficacy of trabectedin in malignant solitary fibrous tumors: a retrospective analysis from the French Sarcoma Group.

PubMed

Khalifa, J; Ouali, M; Chaltiel, L; Le Guellec, S; Le Cesne, A; Blay, J-Y; Cousin, P; Chaigneau, L; Bompas, E; Piperno-Neumann, S; Bui-Nguyen, B; Rios, M; Delord, J-P; Penel, N; Chevreau, C

2015-10-15

Advanced malignant solitary fibrous tumors (SFTs) are rare soft-tissue sarcomas with a poor prognosis. Several treatment options have been reported, but with uncertain rates of efficacy. Our aim is to describe the activity of trabectedin in a retrospective, multi-center French series of patients with SFTs. Patients were mainly identified through the French RetrospectYon database and were treated between January 2008 and May 2013. Trabectedin was administered at an initial dose of 1.5 mg/m(2), q3 weeks. The best tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors 1.1. The Kaplan-Meier method was used to estimate median progression-free survival (PFS) and overall survival (OS). The growth-modulation index (GMI) was defined as the ratio between the time to progression with trabectedin (TTPn) and the TTP with the immediately prior line of treatment (TTPn-1). Eleven patients treated with trabectedin for advanced SFT were identified. Trabectedin had been used as second-line treatment in 8 patients (72.7 %) and as at least third-line therapy in a further 3 (27.3 %). The best RECIST response was a partial response (PR) in one patient (9.1 %) and stable disease (SD) in eight patients (72.7 %). Disease-control rate (DCR = PR + SD) was 81.8 %. After a median follow-up of 29.2 months, the median PFS was 11.6 months (95 % CI = 2.0; 15.2 months) and the median OS was 22.3 months (95 % CI = 9.1 months; not reached). The median GMI was 1.49 (range: 0.11-4.12). Trabectedin is a very promising treatment for advanced SFTs. Further investigations are needed.

Surpassing the Target: How a Recruitment Campaign Transformed the Participant Accrual Trajectory in the Epilepsy Phenome/Genome Project

PubMed Central

Freyer Karn, Catharine; Fox, Kristen

2015-01-01

Abstract Participant recruitment challenges pervade the majority of publicly funded clinical trials. However, little is known about methods for enhancing participant accrual. The Epilepsy Phenome/Genome Project (EPGP), a multicenter study funded by the National Institute of Neurological Disorders and Stroke (NINDS), aimed to enroll a total of 5,250 participants to better understand the genetic causes and phenotypic manifestations of epilepsy. However, similar to other trials, EPGP encountered recruitment challenges, and by the end of its first year, net enrollment was only 48% of the target for that time. To address this, EPGP established a National Participant Recruitment Campaign and began implementing and tracking the enrollment outcomes of a variety of proven and relatively novel recruitment methods. At the conclusion of the project, EPGP had successfully enrolled a total of 5,445 participants, thus surpassing its enrollment target. Data pertaining to EPGP's National Participant Recruitment Campaign was analyzed retrospectively, and the results are reported here, so that other multicenter trials may consider these methods in their recruitment planning and potentially avoid the costly repercussions of participant accrual issues. PMID:26176343

Shunting normal-pressure hydrocephalus: do the benefits outweigh the risks? A multicenter study and literature review.

PubMed

Vanneste, J; Augustijn, P; Dirven, C; Tan, W F; Goedhart, Z D

1992-01-01

We performed a multicenter retrospective study in 166 consecutive patients shunted for presumed normal-pressure hydrocephalus (NPH) in the four neurosurgical departments of Amsterdam. Overall improvement occurred in 36%, substantial improvement in 21%. In the subgroup of idiopathic NPH (N = 127), marked improvement was only 15%. The incidence of shunt-responsive NPH in our area was 2.2/million/year. The rate of severe and moderate shunt-related complications was 28%, leading to death or severe residual morbidity in 7%. The substantial benefit/serious harm ration in the whole group was only three (21%/7%), decreasing to 1.7 in idiopathic NPH. By excluding patients at high surgical risk, this ratio might have risen to 10 in the whole group and to six in idiopathic NPH. Our experience is much less favorable than that encountered in the literature, reporting overall improvement in 74% and marked improvement in 55% of the shunted patients. We conclude that NPH is probably a very rare and still overdiagnosed syndrome and that the overall morbidity rate for each patient demonstrating meaningful improvement is high.

Tug-of-war between classical and multicenter bonds in H-(Be)n-H species

NASA Astrophysics Data System (ADS)

Lundell, Katie A.; Boldyrev, Alexander I.

2018-05-01

Quantum chemical calculations were performed for beryllium homocatenated compounds [H-(Be)n-H]. Global minimum structures were found using machine searches (Coalescence Kick method) with density functional theory. Chemical bonding analysis was performed with the Adaptive Natural Density Partitioning method. It was found that H-(Be)2-H and H-(Be)3-H clusters are linear with classical two-center two-electron bonds, while for n > 3, three-dimensional structures are more stable with multicenter bonding. Thus, at n = 4, multicenter bonding wins the tug-of-war vs. the classical bonding.

Loop ileostomy versus total colectomy as surgical treatment for Clostridium difficile-associated disease: An Eastern Association for the Surgery of Trauma multicenter trial.

PubMed

Ferrada, Paula; Callcut, Rachael; Zielinski, Martin D; Bruns, Brandon; Yeh, Daniel Dante; Zakrison, Tanya L; Meizoso, Jonathan P; Sarani, Babak; Catalano, Richard D; Kim, Peter; Plant, Valerie; Pasley, Amelia; Dultz, Linda A; Choudhry, Asad J; Haut, Elliott R

2017-07-01

The mortality of patients with Clostridium difficile-associated disease (CDAD) requiring surgery continues to be very high. Loop ileostomy (LI) was introduced as an alternative procedure to total colectomy (TC) for CDAD by a single-center study. To date, no reproducible results have been published. The objective of this study was to compare these two procedures in a multicentric approach to help the surgeon decide what procedure is best suited for the patient in need. This was a retrospective multicenter study conducted under the sponsorship of the Eastern Association for the Surgery of Trauma. Demographics, medical history, clinical presentation, APACHE score, and outcomes were collected. We used the Research Electronic Data Capture tool to store the data. Mann-Whitney (continuous data) and Fisher exact (categorical data) were used to compare TC with LI. Logistic regression was performed to determine predictors of mortality. A propensity score analysis was done to control for potential confounders and determine adjusted mortality rates by procedure type. We collected data from 10 centers of patients who presented with CDAD requiring surgery between July 1, 2010 and July 30, 2014. Two patients died during the surgical procedure, leaving 98 individuals in the study. The overall mortality was 32%, and 75% had postoperative complications. Median age was 64.5 years; 59% were male. Concerning preoperative patient conditions, 54% were on pressors, 47% had renal failure, and 36% had respiratory failure. When comparing TC and LI, there was no statistical difference regarding these conditions. Univariate preprocedure predictors of mortality were age, lactate, timing of operation, vasopressor use, and acute renal failure. There was no statistical difference between the APACHE score of patients undergoing either procedure (TC, 22 vs LI, 16). Adjusted mortality (controlled for preprocedure confounders) was significantly lower in the LI group (17.2% vs 39.7%; p = 0.002). This is the first multicenter study comparing TC with LI for the treatment of CDAD. In this study, LI carried less mortality than TC. In patients without contraindications, LI should be considered for the surgical treatment of CDAD. Therapeutic study, level III.

Predictive factors for a one-year improvement in nontuberculous mycobacterial pulmonary disease: An 11-year retrospective and multicenter study

PubMed Central

Ducrot, Rodolphe; Bourdin, Arnaud; Rastogi, Nalin

2017-01-01

Background Nontuberculous mycobacterial pulmonary disease (NTM-PD) has become an emerging infectious disease and is responsible for more deaths than tuberculosis in industrialized countries. NTM-PD mortality remains high in some series reportedly ranging from 25% to 40% at five years and often due to unfavorable evolution of NTM-PD despite established treatment. The purpose of our study was to search for early factors that could predict the favorable or unfavorable evolution of NTM-PD at the first year of treatment. Methods In this retrospective and multicenter study, we selected 119 patients based on clinical, radiological and microbiological data from 2002 to 2012 from three French university hospitals (Guadeloupe, Martinique, Montpellier) with definite (meeting the criteria of the American Thoracic Society and the Infectious Disease Society of America in 2007; ATS/IDSA) or probable (one positive sputum culture) NTM-PD. We compared two patient groups: those who improved at one year (clinical symptoms, radiological lesions and microbiology data) and those who did not improve at one year. The data were analyzed for all patients as well as for subgroups by gender, HIV-positive patients, and Mycobacterium avium complex (MAC) infection. Results The average patient age was 50 years ± 19.4; 58% had respiratory comorbidities, 24% were HIV positive and 19% had cystic fibrosis. Coughing concerned 66% of patients and bronchiectasis concerned 45%. The most frequently isolated NTM were MAC (46%). 57% (n = 68) of patients met the ATS criteria and improved status concerned 38.6% (n = 46). The improvement factors at one year of NTM-PD were associated with the duration of ethambutol treatment: (Odds ratio adjusted [ORa]: 2.24, 95% Confidence interval [CI]; 2.11–3.41), HIV-positive status: (ORa: 3.23, 95% CI; 1.27–8.45), and male gender: (ORa: 2.34, 95% CI; 1.26–8.16). For the group with NTM-PD due to MAC, improvement was associated with the duration of macrolide treatment (ORa: 3.27, 95% CI; 1.88–7.30) and an age <50 years (ORa: 1.88, 95% CI; 1.55–8.50). Conclusion In this retrospective multicenter study, improvement at one year in patients with definite or probable NTM-PD was associated with the duration of ethambutol treatment, HIV-positive status and male gender. For the group of patients infected with MAC, improvement was associated with the duration of macrolide treatment and an age <50 years. Identifying predictors of improvement at one year of NTM-PD is expected to optimize the management of the disease in its early stages. PMID:28787454

Cannabis use and age at onset of symptoms in subjects at clinical high risk for psychosis.

PubMed

Dragt, S; Nieman, D H; Schultze-Lutter, F; van der Meer, F; Becker, H; de Haan, L; Dingemans, P M; Birchwood, M; Patterson, P; Salokangas, R K R; Heinimaa, M; Heinz, A; Juckel, G; Graf von Reventlow, H; French, P; Stevens, H; Ruhrmann, S; Klosterkötter, J; Linszen, D H

2012-01-01

Numerous studies have found a robust association between cannabis use and the onset of psychosis. Nevertheless, the relationship between cannabis use and the onset of early (or, in retrospect, prodromal) symptoms of psychosis remains unclear. The study focused on investigating the relationship between cannabis use and early and high-risk symptoms in subjects at clinical high risk for psychosis. Prospective multicenter, naturalistic field study with an 18-month follow-up period in 245 help-seeking individuals clinically at high risk. The Composite International Diagnostic Interview was used to assess their cannabis use. Age at onset of high risk or certain early symptoms was assessed retrospectively with the Interview for the Retrospective Assessment of the Onset of Schizophrenia. Younger age at onset of cannabis use or a cannabis use disorder was significantly related to younger age at onset of six symptoms (0.33 < r(s) < 0.83, 0.004 < P < 0.001). Onset of cannabis use preceded symptoms in most participants. Our results provide support that cannabis use plays an important role in the development of psychosis in vulnerable individuals. Cannabis use in early adolescence should be discouraged. © 2011 John Wiley & Sons A/S.

Filgrastim mobilization and collection of allogeneic blood progenitor cells from adult family donors: first interim report of a prospective German multicenter study.

PubMed

Beelen, D W; Ottinger, H; Kolbe, K; Pönisch, W; Sayer, H G; Knauf, W; Stockschläder, M; Scheid, C; Schaefer, U W

2002-12-01

Recombinant human granulocyte colony-stimulating factor (rhG-CSF) mobilized peripheral blood progenitor cells (PBPCs) from healthy individuals are a rapidly emerging alternative source to bone marrow for allogeneic transplantation. Although widely applied in the meantime, only limited information on feasibility and safety of mobilization and collection of PBPCs is currently available from prospective multicenter studies specifically designed to investigate this donation modality. This ongoing multicenter study on the performance as well as the short- and long-term safety profile of rhG-CSF-induced mobilization and collection of PBPCs was initiated in October 1999. The study is designed to recruit a total of 300 healthy family donors who will be followed regularly for a period of 5 years after donation. The first interim report presented here summarizes results obtained after enrollment of 150 donors from nine German institutions. The study protocol allowed the individual choice between two dose regimens of rh-CSF (10 micro g/kg per day vs 2x8 micro g/kg per day of donor body weight). The primary endpoint was defined as a yield of > or =5x10(6) CD34(+) cells/kg of recipient body weight in a single leukapheresis product. This endpoint was attained by 50% of donors receiving the lower rhG-CSF dose regimen and by 75% of donors with the higher dose regimen ( p<0.0009). A total of 478 acute adverse events attributable to the mobilization procedure were recorded and manifested predominantly as transient bone pain and headaches (80%). No persistent hematologic or nonhematologic adverse events have occurred in this study so far. Thus, the current experience in a prospective multicenter study supports previous single-center and retrospective registry reports in that the collection of PBPCs after rhG-CSF mobilization is feasible and associated with frequent, but generally mild and acceptable side effects.

Interim analysis of survival in a prospective, multi-center registry cohort of cutaneous melanoma tested with a prognostic 31-gene expression profile test.

PubMed

Hsueh, Eddy C; DeBloom, James R; Lee, Jonathan; Sussman, Jeffrey J; Covington, Kyle R; Middlebrook, Brooke; Johnson, Clare; Cook, Robert W; Slingluff, Craig L; McMasters, Kelly M

2017-08-29

A 31-gene expression profile (GEP) test that provides risk classification of cutaneous melanoma (CM) patients has been validated in several retrospective studies. The objective of the reported study was a prospective evaluation of the GEP performance in patients enrolled in two clinical registries. Three-hundred twenty two CM patients enrolled in the EXPAND (NCT02355587) and INTEGRATE (NCT02355574) registries met the criteria of age ≥ 16 years, successful GEP result and ≥1 follow-up visit for inclusion in this interim analysis. Primary endpoints were recurrence-free (RFS), distant metastasis-free (DMFS), and overall survival (OS). Median follow-up was 1.5 years for event-free patients. Median age for subjects was 58 years (range 18-87) and median Breslow thickness was 1.2 mm (range 0.2-12.0). Eighty-eight percent (282/322) of cases had stage I/II disease and 74% (237/322) had a SLN biopsy. Seventy-seven percent (248/322) had class 1 molecular profiles. 1.5-year RFS, DMFS, and OS rates were 97 vs. 77%, 99 vs. 89%, and 99 vs. 92% for class 1 vs. class 2, respectively (p < 0.0001 for each). Multivariate Cox regression showed Breslow thickness, mitotic rate, and GEP class to significantly predict recurrence (p < 0.01), while tumor thickness was the only significant predictor of distant metastasis and overall survival in this interim analysis. Interim analysis of patient outcomes from a combined prospective cohort supports the 31-gene GEP's ability to stratify early-stage CM patients into two groups with significantly different metastatic risk. RFS outcomes in this real-world cohort are consistent with previously published analyses with retrospective specimens. GEP testing complements current clinicopathologic features and increases identification of high-risk patients. ClinicalTrials.gov, NCT02355574  and NCT02355587.

Impact of novel techniques on minimally invasive adrenal surgery: trends and outcomes from a contemporary international large series in urology.

PubMed

Pavan, Nicola; Autorino, Riccardo; Lee, Hak; Porpiglia, Francesco; Sun, Yinghao; Greco, Francesco; Jeff Chueh, S; Han, Deok Hyun; Cindolo, Luca; Ferro, Matteo; Chen, Xiang; Branco, Anibal; Fornara, Paolo; Liao, Chun-Hou; Miyajima, Akira; Kyriazis, Iason; Puglisi, Marco; Fiori, Cristian; Yang, Bo; Fei, Guo; Altieri, Vincenzo; Jeong, Byong Chang; Berardinelli, Francesco; Schips, Luigi; De Cobelli, Ottavio; Chen, Zhi; Haber, Georges-Pascal; He, Yao; Oya, Mototsugu; Liatsikos, Evangelos; Brandao, Luis; Challacombe, Benjamin; Kaouk, Jihad; Darweesh, Ithaar

2016-10-01

To evaluate contemporary international trends in the implementation of minimally invasive adrenalectomy and to assess contemporary outcomes of different minimally invasive techniques performed at urologic centers worldwide. A retrospective multinational multicenter study of patients who underwent minimally invasive adrenalectomy from 2008 to 2013 at 14 urology institutions worldwide was included in the analysis. Cases were categorized based on the minimally invasive adrenalectomy technique: conventional laparoscopy (CL), robot-assisted laparoscopy (RAL), laparoendoscopic single-site surgery (LESS), and mini-laparoscopy (ML). The rates of the four treatment modalities were determined according to the year of surgery, and a regression analysis was performed for trends in all surgical modalities. Overall, a total of 737 adrenalectomies were performed across participating institutions and included in this analysis: 337 CL (46 % of cases), 57 ML (8 %), 263 LESS (36 %), and 80 RA (11 %). Overall, 204 (28 %) operations were performed with a retroperitoneal approach. The overall number of adrenalectomies increased from 2008 to 2013 (p = 0.05). A transperitoneal approach was preferred in all but the ML group (p < 0.001). European centers mostly adopted CL and ML techniques, whereas those from Asia and South America reported the highest rate in LESS procedures, and RAL was adopted to larger extent in the USA. LESS had the fastest increase in utilization at 6 %/year. The rate of RAL procedures increased at slower rates (2.2 %/year), similar to ML (1.7 %/year). Limitations of this study are the retrospective design and the lack of a cost analysis. Several minimally invasive surgical techniques for the management of adrenal masses are successfully implemented in urology institutions worldwide. CL and LESS seem to represent the most commonly adopted techniques, whereas ML and RAL are growing at a slower rate. All the MIS techniques can be safely and effectively performed for a variety of adrenal disease.

Comparative Effectiveness of Vancomycin Versus Daptomycin for MRSA Bacteremia With Vancomycin MIC >1 mg/L: A Multicenter Evaluation.

PubMed

Moise, Pamela A; Culshaw, Darren L; Wong-Beringer, Annie; Bensman, Joyce; Lamp, Kenneth C; Smith, Winter J; Bauer, Karri; Goff, Debra A; Adamson, Robert; Leuthner, Kimberly; Virata, Michael D; McKinnell, James A; Chaudhry, Saira B; Eskandarian, Romic; Lodise, Thomas; Reyes, Katherine; Zervos, Marcus J

2016-01-01

Clinical studies comparing vancomycin with alternative therapy for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia are limited. The objective of this study was to compare outcomes of early daptomycin versus vancomycin treatment for MRSA bacteremia with high vancomycin MICs in a geographically diverse multicenter evaluation. This nationwide, retrospective, multicenter (N = 11), matched, cohort study compared outcomes of early daptomycin with vancomycin for MRSA bloodstream infection (BSI) with vancomycin MICs 1.5 to 2 µg/mL. Matching variables, based on propensity regression analysis, included age, intensive care unit (ICU), and type of BSI. Outcomes were as follows: (1) composite failure (60-day all-cause mortality, 7-day clinical or microbiologic failure, 30-day BSI relapse, or end-of-treatment failure (EOT; discontinue/change daptomycin or vancomycin because of treatment failure or adverse event]); (2) nephrotoxicity; and (2) day 4 BSI clearance. A total of 170 patients were included. The median (interquartile range) age was 60 years (50-74); the median (range) Acute Physiology and Chronic Health Evaluation II score was 15 (10-18); 31% were in an ICU; and 92% had an infectious disease consultation. BSI types included endocarditis/endovascular (39%), extravascular (55%), and central catheter (6%). The median daptomycin dose was 6 mg/kg, and the vancomycin trough level was 17 mg/L. Overall composite failure was 35% (59 of 170): 15% due to 60-day all-cause mortality, 14% for lack of clinical or microbiologic response by 7 days, and 17% due to failure at end of therapy (discontinue/change because of treatment failure or adverse event). Predictors of composite failure according to multivariate analysis were age >60 years (odds ratio, 3.7; P < 0.01) and ICU stay (odds ratio, 2.64; P = 0.03). Notable differences between treatment groups were seen with: (1) end of therapy failure rates (11% vs 24% for daptomycin vs vancomycin; P = 0.025); (2) acute kidney injury rates (9% vs 23% for daptomycin vs vancomycin; P = 0.043); and (3) day 4 bacteremia clearance rates for immunocompromised patients (n = 26) (94% vs 56% for daptomycin vs vancomycin; P = 0.035). Results from this multicenter study provide, for the first time, a geographically diverse evaluation of daptomycin versus vancomycin for patients with vancomycin-susceptible MRSA bacteremia with vancomycin MIC values >1 µg/mL. Although the overall composite failure rates did not differ between the vancomycin and daptomycin groups when intensively matched according to risks for failure, the rates of acute kidney injury were significantly lower in the daptomycin group. These findings suggest that daptomycin is a useful therapy for clinicians treating patients who have MRSA bacteremia. Prospective, randomized trials should be conducted to better assess the potential significance of elevated vancomycin MIC. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Increasing incidence of glioblastoma multiforme and meningioma, and decreasing incidence of Schwannoma (2000–2008): Findings of a multicenter Australian study

PubMed Central

Dobes, Martin; Khurana, Vini G.; Shadbolt, Bruce; Jain, Sanjiv; Smith, Sarah F.; Smee, Robert; Dexter, Mark; Cook, Raymond

2011-01-01

Background: The incidence of primary brain tumors by subtype is currently unknown in Australia. We report an analysis of incidence by tumor subtype in a retrospective multicenter study in the state of New South Wales (NSW) and the Australian Capital Territory (ACT), with a combined population of >7 million with >97% retention rate for medical care. Methods: Data from histologically confirmed primary brain tumors diagnosed from January 2000 through December 2008 were weighted for patient outflow and data completeness, and age standardized and analyzed using joinpoint analysis. Results: A significant increasing incidence in glioblastoma multiforme (GBM) was observed in the study period (annual percentage change [APC], 2.5; 95% confidence interval [CI], 0.4–4.6, n = 2275), particularly after 2006. In GBM patients in the ≥65-year group, a significantly increasing incidence for men and women combined (APC, 3.0; 95% CI, 0.5–5.6) and men only (APC, 2.9; 95% CI, 0.1–5.8) was seen. Rising trends in incidence were also seen for meningioma in the total male population (APC, 5.3; 95% CI, 2.6–8.1, n = 515) and males aged 20–64 years (APC, 6.3; 95% CI, 3.8–8.8). Significantly decreasing incidence trends were observed for Schwannoma for the total study population (APC, –3.5; 95% CI, –7.2 to –0.2, n = 492), significant in women (APC, –5.3; 95% CI, –9.9 to –0.5) but not men. Conclusion: This collection is the most contemporary data on primary brain tumor incidence in Australia. Our registries may observe an increase in malignant tumors in the next few years that they are not detecting now due to late ascertainment. We recommend a direct, uniform, and centralized approach to monitoring primary brain tumor incidence by subtype, including the introduction of nonmalignant data collection. PMID:22276231

Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data.

PubMed

Kotsias, Andreas; Mularski, Sven; Kühn, Björn; Hanna, Michael; Suess, Olaf

2017-01-01

Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment. Several types of intervertebral spacers can be used, but there is increasing evidence that PEEK cages yield insufficient fusion and thus less clinical improvement. The study aim was to assess the outcomes of single-level ACDF with an empty PEEK cage partially coated with titanium. This prospective multicenter single-arm clinical study collected follow-up data at 6, 12, and 18 months. A post hoc comparison was made to closely matched patients from another similar trial treated with identically designed, empty, uncoated PEEK cages. There were 49 of 50 patients (98%) who met the MCID of 3+ points of improvement on VAS pain or had an 18-month VAS ≤ 1. Yet even by 18 months post-op, only 40 of 50 (80%) PEEK + Ti patients achieved complete bony fusion. The PEEK + Ti group ( n  = 49) seemed to have somewhat better fusion scores and significantly better pain relief at 6 M than the matched controls ( n  = 49), but these differences did not persist at 12 M or 18 M. Patients (with either implant) who achieved complete bony fusion had significantly better improvement of pain at 6 M and disability at 6 M and 12 M than patients that remained unfused. ACDF is effective treatment for cervical myelopathy and radiculopathy. Although this and other studies show that titanium fuses better, partial coating of a PEEK cage does not improve the fusion rate sufficiently or confer other lasting clinical benefit. PEEK cages fully coated with titanium should be tested in prospective randomized comparative trials. Prospective, multicenter, single-arm clinical observational study without an individual Trial registration number. Study design and post hoc data analysis according to the "PIERCE-PEEK study", ISRCTN42774128, retrospectively registered 14 April 2009.

Comparative evaluation of the immunogenicity of combined hepatitis A and B vaccine by a prospective and retrospective trial.

PubMed

Wolters, Bernd; Müller, Tobias; Ross, R Stefan; Clauberg, Ralf; Werfel, Uwe; Roggendorf, Hedwig; Siggelkow, Cornelius; Hausen, Thomas; Roggendorf, Michael

2009-04-01

In the past, immunogenicity of hepatitis A and B vaccines needed to be questioned in persons of advanced age, especially in those of 40 years and older. We performed a comparative multicenter prospective and retrospective study with the combined hepatitis A and B vaccine Twinrix to identify factors influencing the results of the vaccination in a population of all age groups. Out of 489 subjects enrolled, 241 were vaccinated in a prospective study (group 1) and 248 subjects in a retrospective study (group 2) in 17 German centers with median age of 40.1 (14-79) years. Following three applications of the combined hepatitis A/B vaccine we found 96.2% with protective antibodies against HAV and 88.7% were protected against HBV. With increasing age the subjects developed decreasing anti-HBs antibody levels whereas the seroprotection rate was significantly reduced by age (p < 0.05) in the retrospective study group only. Subjects with arterial hypertension and thyroid disease showed significantly decreased protection rates. The timing of the HBV antibody control seems to be important especially in low-responders because protective antibodies may drop below the detection limit within some month. The combined hepatitis A and B vaccine Twinrix proved to be highly effective against HBV, although antibody concentrations and seroprotection rates decreased with increasing age.

A multicenter retrospective survey of poisoning after consumption of products containing synthetic chemicals in Japan.

PubMed

Kamijo, Yoshito; Takai, Michiko; Fujita, Yuji; Hirose, Yasuo; Iwasaki, Yasumasa; Ishihara, Satoshi; Yokoyama, Takashi; Yagi, Keiichi; Sakamoto, Tetsuya

2014-01-01

We conducted a multicenter retrospective survey of patients poisoned by synthetic chemicals (SCs) in Japan. Letters were sent to 467 emergency facilities requesting participation in the study, and questionnaires were mailed to facilities that agreed to participate. Patients The study participants were patients who were transported to emergency facilities between January 2006 and December 2012 after consuming SC-containing products. We surveyed 518 patients from 60 (12.8%) facilities. Most patients were male (82.0%), in their 20s or 30s (80.5%), and had inhaled SCs (87.5%) contained in herbal products (86.0%). Harmful behavior was observed at the scene of poisoning for 56 patients (10.8%), including violence to others or things in 32, traffic accidents in seven, and self-injury or suicide attempts in four. Other than physical and neuropsychiatric symptoms, some patients also had physical complications, such as rhabdomyolysis (10.0%). Of the 182 patients (35.1%) admitted to hospitals, including 29 (5.6%) who needed respirators, all of the 21 (4.1%) hospitalized for at least seven days were male, and 20 had physical complications (rhabdomyolysis, 12; liver dysfunction, 5; renal dysfunction, 11; and physical injuries, 3). Most patients (95.6%) completely recovered, although 10 (1.9%) were transferred to a psychiatric department or hospital, and three (0.6%) were handed over to the police due to combative or violent behavior. SCs such as synthetic cannabinoids, synthetic cathinones, or methoxetamine were detected in 20 product samples. Consuming products containing SCs can result in physical complications, including rhabdomyolysis, injuries, and physical or neuropsychiatric symptoms, which may require active interventions, such as respirator use or prolonged hospitalization.

A Retrospective, Multicenter Study of the Tolerance of Induction Chemotherapy With Docetaxel, Cisplatin, and 5-Fluorouracil Followed by Radiotherapy With Concomitant Cetuximab in 46 Cases of Squamous Cell Carcinoma of the Head and Neck

DOE Office of Scientific and Technical Information (OSTI.GOV)

Buiret, Guillaume, E-mail: guillaume.buiret@laposte.ne; Service de biostatistique, Hospices Civils de Lyon, Lyon; Combe, Claire

2010-06-01

Purpose: To investigate, in a multicenter study, the tolerance of induction chemotherapy (ICT) and external radiotherapy (ERT) with concomitant cetuximab in the treatment of patients with squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Clinical data from 46 patients with Stage III or IV nonmetastatic SCCHN who received docetaxel, cisplatin, and 5-fluorouracil as ICT, followed by ERT with concomitant cetuximab, were retrospectively analyzed. Clinical safety (weight, allergy, mucositis, and dermatitis) and paraclinical safety (levels of hemoglobin, polynuclear neutrophils, and creatinine clearance) were studied. The primary objective was the proportion of patients who completed the protocol. Results:more » The percentage of patients completing ICT was 73.9%, ERT 93.5%, and cetuximab 69.6%. Induction chemotherapy was better tolerated than that previously reported. The rates of temporary suspensions of radiation (39.1%, mean duration of 13 days) and hospitalization (26.1%) during ERT with concomitant cetuximab were high. Weight loss during treatment (21.4% of patients lost >10% of their body weight), radiodermatitis, and radiomucositis were the main causes of temporary suspension of treatment, although Grade 4 dermatitis was not experienced. There were no allergic reactions to cetuximab. Conclusion: The completed protocol rate for SCCHN patients receiving ICT and ERT with concomitant cetuximab is high and the toxicity acceptable. Future improvements to protocol will be possible through early action and systematic implementation of nutritional support coupled with antibiotic treatment upon the first signs of radiodermatitis. These data could be useful for prospective studies on the safety and efficacy of this protocol.« less

Efficacy and safety of rituximab for systemic lupus erythematosus-associated immune cytopenias: A multicenter retrospective cohort study of 71 adults.

PubMed

Serris, Alexandra; Amoura, Zahir; Canouï-Poitrine, Florence; Terrier, Benjamin; Hachulla, Eric; Costedoat-Chalumeau, Nathalie; Papo, Thomas; Lambotte, Olivier; Saadoun, David; Hié, Miguel; Blanche, Philippe; Lioger, Bertrand; Gottenberg, Jacques-Eric; Godeau, Bertrand; Michel, Marc

2018-03-01

The aim of the study was to assess the efficacy and safety of rituximab (RTX) for treating systemic lupus erythematosus (SLE)-associated immune cytopenias. This multicenter retrospective cohort study of adults from French referral centers and networks for adult immune cytopenias and SLE involved patients ≥18 years old with a definite diagnosis of SLE treated with RTX specifically for SLE-associated immune cytopenia from 2005 to 2015. Response assessment was based on standard definitions. In total, 71 patients, 61 women (85.9%), with median age 36 years [interquartile range 31-48], were included. The median duration of SLE at the time of the first RTX administration was 6.1 years [2.6-11.6] and the reason for using RTX was immune thrombocytopenia (ITP) for 44 patients (62.0%), autoimmune hemolytic anemia (AIHA) for 16 (22.5%), Evans syndrome for 10 (14.1%), and pure red cell aplasia for one patient. Before receiving RTX, patients had received a mean of 3.1 ± 1.3 treatments that included corticosteroids (100%), and hydroxychloroquine (88.5%). The overall initial response rate to RTX was 86% (91% with ITP, 87.5% with AIHA, and 60% with Evans syndrome), including 60.5% with complete response. Median follow-up after the first injection of RTX was 26.4 months [14.3-71.2]. Among 61 initial responders, relapse occurred in 24 (39.3%); for 18, RTX retreatment was successful in 16 (88.8%). Severe infections occurred after RTX in three patients, with no fatal outcome. No cases of RTX-induced neutropenia were observed. In conclusion, RTX seems effective and relatively safe for treating SLE-associated immune cytopenias. © 2017 Wiley Periodicals, Inc.

Nighttime intensivist staffing, mortality, and limits on life support: a retrospective cohort study.

PubMed

Kerlin, Meeta Prasad; Harhay, Michael O; Kahn, Jeremy M; Halpern, Scott D

2015-04-01

Evidence regarding nighttime physician staffing of ICUs is suboptimal. We aimed to determine how nighttime physician staffing models influence patient outcomes. We performed a multicenter retrospective cohort study in a multicenter registry of US ICUs. The exposure variable was the ICU's nighttime physician staffing model. The primary outcome was hospital mortality. Secondary outcomes included new limitations on life support, ICU length of stay, hospital length of stay, and duration of mechanical ventilation. Daytime physician staffing was studied as a potential effect modifier. The study included 270,742 patients in 143 ICUs. Compared with nighttime staffing with an attending intensivist, nighttime staffing without an attending intensivist was not associated with hospital mortality (OR, 1.03; 95% CI, 0.92-1.15; P = .65). This relationship was not modified by daytime physician staffing (interaction P = .19). When nighttime staffing was subcategorized, neither attending nonintensivist nor physician trainee staffing was associated with hospital mortality compared with attending intensivist staffing. However, nighttime staffing without any physician was associated with reduced odds of hospital mortality (OR, 0.79; 95% CI, 0.68-0.91; P = .002) and new limitations on life support (OR, 0.83; 95% CI, 0.75-0.93; P = .001). Nighttime staffing was not associated with ICU or hospital length of stay. Nighttime staffing with an attending nonintensivist was associated with a slightly longer duration of mechanical ventilation (hazard ratio, 1.05; 95% CI, 1.02-1.09; P < .001). We found little evidence that nighttime physician staffing models affect patient outcomes. ICUs without physicians at night may exhibit reduced hospital mortality that is possibly attributable to differences in end-of-life care practices.

Unique characteristics and failure patterns of metaplastic breast cancer in contrast to invasive ductal carcinoma: a retrospective multicenter case-control study (KROG 13-07).

PubMed

Yu, Jeong Il; Choi, Doo Ho; Huh, Seung Jae; Ahn, Sung Ja; Lee, Ji Shin; Shin, Kyung Hwan; Kwon, Youngmee; Kim, Yong Bae; Suh, Chang-Ok; Kim, Jin Hee; Cho, Jihyoung; Kim, In Ah; Lee, Jong Hoon; Park, Won

2015-04-01

This retrospective study was performed to investigate the need for management modification in MBC according to evaluation of characteristics and failure patterns compared with IDC. We performed this multicenter study taking MBC and randomly assigned IDC cases matched for age (± 3 years), pathologic stage (T and N), locoregional treatment methods (surgery with or without radiation therapy), and period of treatment (± 6 months) that occurred from January 1999 to November 2011 in the 6 institutions of the Korean Radiation Oncology Group. A total of 144 female MBC patients were enrolled. The median follow-up was 51 months (range, 1-186 months). The rates of positivity for estrogen receptor (P < .001), progesterone receptor (P < .001), and HER2 (P = .007) were significantly lower in MBC patients. During follow-up, recurrence developed in 22 (15.3%) MBC and 6 (4.2%) IDC patients (P = .002). The median time to recurrence of MBC and IDC was 15 months and 24 months, respectively. Most instances of recurrence in MBC developed in the triple-negative (TN) subgroup (TN-MBC). In particular, locoregional recurrence developed exclusively in the TN-MBC subgroup. In the TN-MBC subgroup, the number of risk factors (pT2-3, N1-3) was related to significant differences in overall survival (P = .001) and recurrence-free survival (P < .001). The MBC patients had a higher rate of TN, poorer differentiation, and a higher recurrence rate than did the IDC patients. Considering the unique characteristics and failure patterns, it is necessary to modify the current management guidelines for MBC. Copyright © 2015 Elsevier Inc. All rights reserved.

A multicenter retrospective survey of poisoning after consumption of products containing novel psychoactive substances from 2013 to 2014 in Japan.

PubMed

Kamijo, Yoshito; Takai, Michiko; Fujita, Yuji; Sakamoto, Tetsuya

2016-09-01

In Japan, fatalities among patients who experienced an acute reaction following self-administration of novel psychoactive substances (NPS) have been more frequently reported since June 2014. This survey aimed to document and analyze trends in NPS consumption in emergency patients. We conducted a multicenter retrospective survey of patients who were transported to emergency facilities after consuming NPS-containing products between January 2013 and December 2014. Letters requesting participation were sent to 467 emergency facilities, and questionnaires were mailed to facilities that agreed to participate. We surveyed 589 patients from 85 (18.2%) facilities. Most patients were male (89.6%) and young (median age, 30 years), and inhaled (88%) NPS contained in herbal products (80.5%). Harmful behavior was observed at the scene of acute reaction, including violence (6.9%), traffic accidents (4.9%), and self-injury or suicidal attempts (1.1%). Other than neuropsychiatric and physical symptoms, many patients also had physical complications such as rhabdomyolysis (17.5%), liver injury (12.4%), acute kidney injury (9%), and physical injury (1.9%). Of the 256 patients (43.5%) admitted to hospitals, 35 (5.9%) were hospitalized for seven or more days. Most patients (93.2%) completely recovered, although a few (1.4%) died. However, synthetic cannabinoids and synthetic cathinones were only detected in the blood of five patients. Consumption of NPS-containing products have been associated with harmful behaviors such as violence and traffic accidents, physical complications (e.g., rhabdomyolysis, liver injury), death, or physical and neuropsychiatric symptoms. Compared to a previous survey (2006-2012), the present survey revealed more severe toxicity.

Multi-Center Retrospective Evaluation of Screw and Polymethylmethacrylate Constructs for Atlantoaxial Fixation in Dogs.

PubMed

Stout Steele, Megan W; Hodshon, Amy W; Hopkins, Andrew L; Tracy, Gaemia M; Cohen, Noah D; Kerwin, Sharon C; Boudreau, C Elizabeth; Thomas, William B; Mankin, Joseph M; Levine, Jonathan M

2016-10-01

To evaluate outcome and adverse events following ventral stabilization of the atlantoaxial (AA) joint in dogs with clinical AA subluxation using screw/polymethymethacrylate (PMMA) constructs in a retrospective, multi-center cohort study. Historical cohort study. 35 client-owned dogs. Medical records from 3 institutions were reviewed to identify dogs with AA subluxation treated with ventral screw and PMMA constructs. Data on signalment, pre- and postoperative neurologic status, imaging performed, and adverse events were retrieved. Neurologic examination data were abstracted to generate a modified Frankel score at admission, discharge, and re-examination. Telephone interview of owners >180 days postoperative was conducted. Thirty-five dogs with AA subluxation treated with ventral screw/PMMA constructs were included. Most dogs were young (median age 1 year), small breed dogs with acute onset of neurologic signs (median duration 22.5 hours). Most dogs were non-ambulatory at the time of admission (median modified Frankel score 3). Adverse events were identified in 15/35 dogs including 9 dogs with major adverse events. Four dogs required a second surgery due to vertebral canal violation (n = 2) or implant failure (n = 2). Re-examination at 4-6 weeks postoperative reported 15/28 dogs with improved neurologic status and 19/28 dogs were ambulatory. Telephone follow-up was available for 23/35 dogs with 23/23 reported as ambulatory (median follow-up 390 days). Ventral application of screw and PMMA constructs for AA subluxation, as described here, is associated with clinical improvement in the majority of dog. Major adverse events are infrequent and the technique is considered relatively safe. © Copyright 2016 by The American College of Veterinary Surgeons.

Treatment of femur fractures in young children: a multicenter comparison of flexible intramedullary nails to spica casting in young children aged 2 to 6 years.

PubMed

Heffernan, Michael J; Gordon, J Eric; Sabatini, Coleen S; Keeler, Kathryn A; Lehmann, Charles L; O'Donnell, June C; Seehausen, Derek A; Luhmann, Scott J; Arkader, Alexandre

2015-03-01

Spica casting is the standard of care for femur fractures in children up to 6 years of age. The indications for surgery are controversial. We sought to compare immediate spica casting (Spica) and flexible intramedullary nailing [titanium elastic nailing (TEN)] in a group of children ages 2 to 6 years. We hypothesized that young children can be successfully treated with flexible nails, resulting in faster return to ambulation and an equivalent complication rate when compared with spica casting. This was a multicenter retrospective review of 215 patients, 141 treated with immediate spica casting, and 74 treated with elastic nails. Patient demographics, fracture characteristics, mechanism of injury, associated injuries, outcomes, and complications were recorded and compared between the 2 groups. Patients in the elastic nailing group were more likely to be injured as a pedestrian struck by an automobile (Spica 8% vs. TEN 26%, P=0.001), and had increased rates of associated injuries (P<0.001). Time to fracture union was similar between the 2 groups (P=0.652). The TEN group had shorter time to independent ambulation (Spica 51±14 vs. TEN 29±14 d, P<0.001) and return to full activities (Spica 87±19 vs. TEN 74±28 d, P=0.023). TEN is a reasonable option for treatment of femur fractures in young children when compared with spica casting with shorter time to independent ambulation and full activities. Fractures associated with a high-energy mechanism are especially appropriate for consideration of treatment with TEN. Level III, this was a retrospective comparative study.

A Retrospective Belgian Multi-Center MRI Biomarker Study in Alzheimer's Disease (REMEMBER).

PubMed

Niemantsverdriet, Ellis; Ribbens, Annemie; Bastin, Christine; Benoit, Florence; Bergmans, Bruno; Bier, Jean-Christophe; Bladt, Roxanne; Claes, Lene; De Deyn, Peter Paul; Deryck, Olivier; Hanseeuw, Bernard; Ivanoiu, Adrian; Lemper, Jean-Claude; Mormont, Eric; Picard, Gaëtane; Salmon, Eric; Segers, Kurt; Sieben, Anne; Smeets, Dirk; Struyfs, Hanne; Thiery, Evert; Tournoy, Jos; Triau, Eric; Vanbinst, Anne-Marie; Versijpt, Jan; Bjerke, Maria; Engelborghs, Sebastiaan

2018-01-01

Magnetic resonance imaging (MRI) acquisition/processing techniques assess brain volumes to explore neurodegeneration in Alzheimer's disease (AD). We examined the clinical utility of MSmetrix and investigated if automated MRI volumes could discriminate between groups covering the AD continuum and could be used as a predictor for clinical progression. The Belgian Dementia Council initiated a retrospective, multi-center study and analyzed whole brain (WB), grey matter (GM), white matter (WM), cerebrospinal fluid (CSF), cortical GM (CGM) volumes, and WM hyperintensities (WMH) using MSmetrix in the AD continuum. Baseline (n = 887) and follow-up (FU, n = 95) T1-weighted brain MRIs and time-linked neuropsychological data were available. The cohort consisted of cognitively healthy controls (HC, n = 93), subjective cognitive decline (n = 102), mild cognitive impairment (MCI, n = 379), and AD dementia (n = 313). Baseline WB and GM volumes could accurately discriminate between clinical diagnostic groups and were significantly decreased with increasing cognitive impairment. MCI patients had a significantly larger change in WB, GM, and CGM volumes based on two MRIs (n = 95) compared to HC (FU>24months, p = 0.020). Linear regression models showed that baseline atrophy of WB, GM, CGM, and increased CSF volumes predicted cognitive impairment. WB and GM volumes extracted by MSmetrix could be used to define the clinical spectrum of AD accurately and along with CGM, they are able to predict cognitive impairment based on (decline in) MMSE scores. Therefore, MSmetrix can support clinicians in their diagnostic decisions, is able to detect clinical disease progression, and is of help to stratify populations for clinical trials.

Conducting multicenter research in healthcare simulation: Lessons learned from the INSPIRE network.

PubMed

Cheng, Adam; Kessler, David; Mackinnon, Ralph; Chang, Todd P; Nadkarni, Vinay M; Hunt, Elizabeth A; Duval-Arnould, Jordan; Lin, Yiqun; Pusic, Martin; Auerbach, Marc

2017-01-01

Simulation-based research has grown substantially over the past two decades; however, relatively few published simulation studies are multicenter in nature. Multicenter research confers many distinct advantages over single-center studies, including larger sample sizes for more generalizable findings, sharing resources amongst collaborative sites, and promoting networking. Well-executed multicenter studies are more likely to improve provider performance and/or have a positive impact on patient outcomes. In this manuscript, we offer a step-by-step guide to conducting multicenter, simulation-based research based upon our collective experience with the International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE). Like multicenter clinical research, simulation-based multicenter research can be divided into four distinct phases. Each phase has specific differences when applied to simulation research: (1) Planning phase , to define the research question, systematically review the literature, identify outcome measures, and conduct pilot studies to ensure feasibility and estimate power; (2) Project Development phase , when the primary investigator identifies collaborators, develops the protocol and research operations manual, prepares grant applications, obtains ethical approval and executes subsite contracts, registers the study in a clinical trial registry, forms a manuscript oversight committee, and conducts feasibility testing and data validation at each site; (3) Study Execution phase , involving recruitment and enrollment of subjects, clear communication and decision-making, quality assurance measures and data abstraction, validation, and analysis; and (4) Dissemination phase , where the research team shares results via conference presentations, publications, traditional media, social media, and implements strategies for translating results to practice. With this manuscript, we provide a guide to conducting quantitative multicenter research with a focus on simulation-specific issues.

Predicting Blunt Cerebrovascular Injury in Pediatric Trauma: Validation of the “Utah Score”

PubMed Central

Ravindra, Vijay M.; Bollo, Robert J.; Sivakumar, Walavan; Akbari, Hassan; Naftel, Robert P.; Limbrick, David D.; Jea, Andrew; Gannon, Stephen; Shannon, Chevis; Birkas, Yekaterina; Yang, George L.; Prather, Colin T.; Kestle, John R.

2017-01-01

Abstract Risk factors for blunt cerebrovascular injury (BCVI) may differ between children and adults, suggesting that children at low risk for BCVI after trauma receive unnecessary computed tomography angiography (CTA) and high-dose radiation. We previously developed a score for predicting pediatric BCVI based on retrospective cohort analysis. Our objective is to externally validate this prediction score with a retrospective multi-institutional cohort. We included patients who underwent CTA for traumatic cranial injury at four pediatric Level I trauma centers. Each patient in the validation cohort was scored using the “Utah Score” and classified as high or low risk. Before analysis, we defined a misclassification rate <25% as validating the Utah Score. Six hundred forty-five patients (mean age 8.6 ± 5.4 years; 63.4% males) underwent screening for BCVI via CTA. The validation cohort was 411 patients from three sites compared with the training cohort of 234 patients. Twenty-two BCVIs (5.4%) were identified in the validation cohort. The Utah Score was significantly associated with BCVIs in the validation cohort (odds ratio 8.1 [3.3, 19.8], p < 0.001) and discriminated well in the validation cohort (area under the curve 72%). When the Utah Score was applied to the validation cohort, the sensitivity was 59%, specificity was 85%, positive predictive value was 18%, and negative predictive value was 97%. The Utah Score misclassified 16.6% of patients in the validation cohort. The Utah Score for predicting BCVI in pediatric trauma patients was validated with a low misclassification rate using a large, independent, multicenter cohort. Its implementation in the clinical setting may reduce the use of CTA in low-risk patients. PMID:27297774

Pemetrexed Singlet Versus Nonpemetrexed-Based Platinum Doublet as Second-Line Chemotherapy after First-Line Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Failure in Non-small Cell Lung Cancer Patients with EGFR Mutations.

PubMed

Park, Sehhoon; Keam, Bhumsuk; Kim, Se Hyun; Kim, Ki Hwan; Kim, Yu Jung; Kim, Jin-Soo; Kim, Tae Min; Lee, Se-Hoon; Kim, Dong-Wan; Lee, Jong Seok; Heo, Dae Seog

2015-10-01

Platinum-based doublet chemotherapy is the treatment of choice for patients with non-small cell lung cancer (NSCLC); however, the role of a platinum-based doublet as second-line therapy after failure of an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for NSCLC patients has not yet been elucidated. The purpose of this study was to compare the clinical efficacy of pemetrexed versus a platinum-based doublet as second-line therapy after failure of EGFR TKI used as first-line therapy for NSCLC patients with EGFR mutations. We designed a multicenter retrospective cohort study of 314 NSCLC patients with EGFR mutations who received an EGFR TKI as first-line palliative chemotherapy. Our analysis included 83 patients who failed EGFR TKI therapy and received second-line cytotoxic chemotherapy. Forty-six patients were treated using a platinum-based doublet and 37 patients were treated using singlet pemetrexed. The overall response rates of patients receiving a platinum-based doublet and patients receiving pemetrexed were17.4% and 32.4%, respectively (p=0.111). The median progression-free survival (PFS) of patients receiving pemetrexed was significantly longer than that of patients receiving a platinum-based doublet (4.2 months vs. 2.7 months, respectively; p=0.008). The hazard ratio was 0.54 (95% confidence interval, 0.34 to 0.86; p=0.009). Our retrospective analysis found that second-line pemetrexed singlet therapy provided significantly prolonged PFS compared to second-line platinum-based doublet chemotherapy for NSCLC patients with EGFR mutations who failed first-line EGFR TKI. Conduct of prospective studies for confirmation of our results is warranted.

The specialty of the treating physician affects the likelihood of tumor-free resection margins for basal cell carcinoma: results from a multi-institutional retrospective study.

PubMed

Fleischer, A B; Feldman, S R; Barlow, J O; Zheng, B; Hahn, H B; Chuang, T Y; Draft, K S; Golitz, L E; Wu, E; Katz, A S; Maize, J C; Knapp, T; Leshin, B

2001-02-01

Basal cell carcinoma (BCC) is the most common cutaneous malignancy. Surgical experience and physician specialty may affect the outcome quality of surgical excision of BCC. We performed a multicenter retrospective study of BCC excisions submitted to the respective Departments of Pathology at 4 major university medical centers. Our outcome measure was presence of histologic evidence of tumor present in surgical margins of excision specimens (incomplete excision). Clinician experience was defined as the number of excisions that a clinician performed during the study interval. The analytic sample pool included 1459 tumors that met all inclusion and exclusion criteria. Analyses included univariate and multivariate techniques involving the entire sample and separate subsample analyses that excluded 2 outlying dermatologists. Tumor was present at the surgical margins in 243 (16.6%) of 1459 specimens. A patient's sex, age, and tumor size were not significantly related to the presence of tumor in the surgical margin. Physician experience did not demonstrate a significant difference either in the entire sample (P <.09) or in the subsample analysis (P >.30). Tumors of the head and neck were more likely to be incompletely excised than truncal tumors in all the analyses (P <.03). Compared with dermatologists, otolaryngologists (P <.02) and plastic surgeons (P <.008) were more likely to incompletely excise tumors; however, subsample analysis for plastic surgeons found only a trend toward significance (P <.10). Dermatologists and general surgeons did not differ in the likelihood of performing an incomplete excision (P >.4). The physician specialty may affect the quality of care in the surgical management of BCC.

Ewing-like sarcomas with BCOR-CCNB3 fusion transcript: a clinical, radiological and pathological retrospective study from the Société Française des Cancers de L'Enfant.

PubMed

Cohen-Gogo, Sarah; Cellier, Cécile; Coindre, Jean-Michel; Mosseri, Véronique; Pierron, Gaëlle; Guillemet, Cécile; Italiano, Antoine; Brugières, Laurence; Orbach, Daniel; Laurence, Valérie; Delattre, Olivier; Michon, Jean

2014-12-01

This retrospective multicenter study assessed the clinical, radiological and pathological presentation, treatment and outcome of 26 patients with Ewing-like sarcoma harboring BCOR-CCNB3 gene fusion transcript. Tumor samples had been collected between 1994 and April 2012. Eligibility criteria included assessment of a BCOR-CCNB3 transcript-positive tumor after molecular analysis and availability of minimal clinical and pathological data. Radiological data were also retrieved when possible. Data were analyzed by descriptive statistics and methods for survival analysis. Median age at diagnosis was 13.1 years (5.9 to 25.6 years). Most patients (24/26) had localized tumors. All tumors but five were localized to bone. CCNB3 immunochemistry showed strong nuclear staining on all samples. No specific radiological features were found. Most patients received chemotherapy (15 according to protocols designed for Ewing tumors), before and/or after local treatment (surgery and/or radiotherapy, with 46.2% receiving both). Local and metastatic relapses were of poor prognosis. Induction chemotherapy and treatment according to an Ewing protocol might influence survival for patients with localized tumors. Sixteen patients are alive in complete remission with a median follow-up of 86 months. Five year overall survival and disease-free survival were respectively 76.5% (95% CI, 58%-95%) and 67.9% (95% CI, 48%-88%). BCOR-CCNB3 transcript-positive Ewing-like sarcoma diagnosis should be discussed for a transcript-negative small round cell sarcoma in a child, adolescent or young adult patient. Diagnosis needs to be stated through CCNB3 immunochemistry or transcript identification. The exquisite chemosensitivity of these tumors should encourage the use of polychemotherapy for appropriate care, associated with best local tumor control. © 2014 Wiley Periodicals, Inc.

Safety of endoscopic removal of self-expandable stents after treatment of benign esophageal diseases.

PubMed

van Halsema, Emo E; Wong Kee Song, Louis M; Baron, Todd H; Siersema, Peter D; Vleggaar, Frank P; Ginsberg, Gregory G; Shah, Pari M; Fleischer, David E; Ratuapli, Shiva K; Fockens, Paul; Dijkgraaf, Marcel G W; Rando, Giacomo; Repici, Alessandro; van Hooft, Jeanin E

2013-01-01

Temporary placement of self-expandable stents has been increasingly used for the management of benign esophageal diseases. To evaluate the safety of endoscopic removal of esophageal self-expandable stents placed for the treatment of benign esophageal diseases. Multicenter retrospective study. Six tertiary care centers in the United States and Europe. A total of 214 patients with benign esophageal diseases undergoing endoscopic stent removal. Endoscopic stent removal. Endoscopic techniques for stent removal, time to stent removal, and adverse events related to stent removal. A total of 214 patients underwent a total of 329 stent extractions. Stents were mainly placed for refractory strictures (49.2%) and fistulae (49.8%). Of the removed stents, 52% were fully covered self-expandable metal stents (FCSEMSs), 28.6% were partially covered self-expandable metal stents (PCSEMSs), and 19.5% were self-expandable plastic stents. A total of 35 (10.6%) procedure-related adverse events were reported, including 7 (2.1%) major adverse events. Multivariate analysis revealed that use of PCSEMSs (P < .001) was a risk factor for adverse events during stent removal. Favorable factors for successful stent removal were FCSEMSs (P ≤ .012) and stent migration (P = .010). No significant associations were found for stent indwelling time (P = .145) and stent embedding (P = .194). Retrospective analysis, only tertiary care centers. With an acceptable major adverse event rate of 2.1%, esophageal stent removal in the setting of benign disease was found to be a safe and feasible procedure. FCSEMSs were more successfully removed than self-expandable plastic stents and PCSEMSs. Adverse events caused by stent removal were not time dependent. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Audiometric analyses confirm a cochlear component, disproportional to age, in stapedial otosclerosis.

PubMed

Topsakal, Vedat; Fransen, Erik; Schmerber, Sébastien; Declau, Frank; Yung, Matthew; Gordts, Frans; Van Camp, Guy; Van de Heyning, Paul

2006-09-01

To report the preoperative audiometric profile of surgically confirmed otosclerosis. Retrospective, multicenter study. Four tertiary referral centers. One thousand sixty-four surgically confirmed patients with otosclerosis. Therapeutic ear surgery for hearing improvement. Preoperative audiometric air conduction (AC) and bone conduction (BC) hearing thresholds were obtained retrospectively for 1064 patients with otosclerosis. A cross-sectional multiple linear regression analysis was performed on audiometric data of affected ears. Influences of age and sex were analyzed and age-related typical audiograms were created. Bone conduction thresholds were corrected for Carhart effect and presbyacusis; in addition, we tested to see if separate cochlear otosclerosis component existed. Corrected thresholds were than analyzed separately for progression of cochlear otosclerosis. The study population consisted of 35% men and 65% women (mean age, 44 yr). The mean pure-tone average at 0.5, 1, and 2 kHz was 57 dB hearing level. Multiple linear regression analysis showed significant progression for all measured AC and BC thresholds. The average annual threshold deterioration for AC was 0.45 dB/yr and the annual threshold deterioration for BC was 0.37 dB/yr. The average annual gap expansion was 0.08 dB/year. The corrected BC thresholds for Carhart effect and presbyacusis remained significantly different from zero, but only showed progression at 2 kHz. The preoperative audiological profile of otosclerosis is described. There is a significant sensorineural component in patients with otosclerosis planned for stapedotomy, which is worse than age-related hearing loss by itself. Deterioration rates of AC and BC thresholds have been reported, which can be helpful in clinical practice and might also guide the characterization of allegedly different phenotypes for familial and sporadic otosclerosis.

Use of thalidomide for severe recurrent aphthous stomatitis: a multicenter cohort analysis.

PubMed

Hello, Muriel; Barbarot, Sébastien; Bastuji-Garin, Sylvie; Revuz, Jean; Chosidow, Olivier

2010-05-01

Severe recurrent aphthous stomatitis (SRAS) is a rare, disabling disorder of unknown etiology. Thalidomide is an effective second-line therapy for SRAS, but is suppressive rather than curative, and adverse events limit its use. Few reports describe the efficacy, tolerance, and safety of thalidomide, and how it is actually used as long-term (maintenance) therapy for SRAS. Therefore, we conducted this study to describe thalidomide use in the real-life management of a cohort of patients with SRAS. This multicenter retrospective cohort study covered a period of 5 years and 5 months (January 2003-May 2008). Patients who had started thalidomide monotherapy for SRAS during the 2003-2006 period were eligible. Data were collected from patients' medical charts and supplemented by patients' responses during a targeted telephone interview. Ninety-two patients followed at 14 centers were included: 76 had oral or bipolar aphthosis, and 16 had Behçet disease. Thalidomide was rapidly effective: 85% (78/92) entered complete remission (CR) within a median of 14 days. Response time was independent of the initial thalidomide dose (r = 0.04). Thalidomide was continued for > or =3 months (maintenance therapy) by 77/92 (84%) of the patients on 1 of 2 maintenance regimens: continuous therapy with regular intake (60/77) or intermittent therapy in response to attacks (17/77). Although intermittent therapy was less restrictive than continuous therapy, medical supervision under the former was less rigorous. The median maintenance dose was 100 mg/week, and did not reflect the initial dose (r = 0.18). The intermittent-treatment group's median dose was significantly lower and its median duration of thalidomide intake significantly longer than for patients on continuous therapy (19 vs. 150 mg/wk; p < 0.0001, and 32 vs. 19 mo; p = 0.002, respectively). Adverse events were reported by 84% (77/92) of patients. They were mostly mild (78% of patients), but sometimes severe (21%). Nevertheless, after 40 months of follow-up, 60% of patients were still receiving continuous or intermittent maintenance therapy with favorable efficacy/tolerance ratios. Despite its retrospective nature, this detailed study provides novel information on the different ways thalidomide is used as SRAS maintenance therapy in a large and unselected cohort of patients. Low-dose maintenance regimens appear to be widely used, effective, and relatively well tolerated. These observations suggest the value of undertaking a randomized trial to assess various maintenance regimens.

Transcatheter Arterial Embolization for Bleeding Peptic Ulcers: A Multicenter Study.

PubMed

Spiliopoulos, Stavros; Inchingolo, Riccardo; Lucatelli, Pierleone; Iezzi, Roberto; Diamantopoulos, Athanasios; Posa, Alessandro; Barry, Bryan; Ricci, Carmelo; Cini, Marco; Konstantos, Chrysostomos; Palialexis, Konstantinos; Reppas, Lazaros; Trikola, Artemis; Nardella, Michele; Adam, Andreas; Brountzos, Elias

2018-04-18

To investigate the outcomes of transcatheter arterial embolization (TAE) for the treatment of peptic ulcer bleeding (PUB). This is a retrospective, multicenter study, which investigated all patients who underwent TAE for the treatment of severe upper gastrointestinal hemorrhage from peptic ulcers in five European centers, between January 1, 2012 and May 1, 2017. All patients had undergone failed endoscopic hemostasis. Forty-four patients (male; mean age 74.0 ± 11.1 years, range 49-94), with bleeding from duodenum (36/44; 81.8%) or gastric ulcer (8/44; 18.2%) were followed up to 3.5 years (range 2-1354 days). In 42/44 cases, bleeding was confirmed by pre-procedural CT angiography. In 50% of the cases, coils were deployed, while in the remaining glue, microparticles, gel foam and combinations of the above were used. The study's outcome measures were 30-day survival technical success (occlusion of feeding vessel and/or no extravasation at completion DSA), overall survival, bleeding relapse and complication rates. The technical success was 100%. The 30-day survival rate was 79.5% (35/44 cases). No patients died due to ongoing or recurrent hemorrhage. Re-bleeding occurred in 2/44 cases (4.5%) and was successfully managed with repeat TAE (one) or surgery (one). The rate of major complications was 4.5% (2/44; one acute pancreatitis and one partial pancreatic ischemia), successfully managed conservatively. According to Kaplan-Meier analysis survival was 71.9% at 3.5 years. TAE for the treatment of PUB was technically successful in all cases and resulted in high clinical success rate. Minimal re-bleeding rates further highlight the utility of TAE as the second line treatment of choice, after failed endoscopy.

Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study.

PubMed

Abbott, Sara; Unger, Cecile A; Evans, Janelle M; Jallad, Karl; Mishra, Kevita; Karram, Mickey M; Iglesia, Cheryl B; Rardin, Charles R; Barber, Matthew D

2014-02-01

The purpose of this study was to describe the evaluation and management of synthetic mesh-related complications after surgery for stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). We conducted a multicenter, retrospective analysis of women who attended 4 US tertiary referral centers for evaluation of mesh-related complications after surgery for SUI and/or POP from January 2006 to December 2010. Demographic, clinical, and surgical data were abstracted from the medical record, and complications were classified according to the Expanded Accordion Severity Classification. Three hundred forty-seven patients sought management of synthetic mesh-related complications over the study period. Index surgeries were performed for the following indications: SUI (sling only), 49.9%; POP (transvaginal mesh [TVM] or sacrocolpopexy only), 25.6%; and SUI + POP (sling + TVM or sacrocolpopexy), 24.2%. Median time to evaluation was 5.8 months (range, 0-65.2). Thirty percent of the patients had dyspareunia; 42.7% of the patients had mesh erosion; and 34.6% of the patients had pelvic pain. Seventy-seven percent of the patients had a grade 3 or 4 (severe) complication. Patients with TVM or sacrocolpopexy were more likely to have mesh erosion and vaginal symptoms compared with sling only. The median number of treatments for mesh complications was 2 (range, 1-9); 60% of the women required ≥2 interventions. Initial treatment intervention was surgical for 49% of subjects. Of those treatments that initially were managed nonsurgically, 59.3% went on to surgical intervention. Most of the women who seek management of synthetic mesh complication after POP or SUI surgery have severe complications that require surgical intervention; a significant proportion require >1 surgical procedure. The pattern of complaints differs by index procedure. Copyright © 2014 Mosby, Inc. All rights reserved.

First-line chemotherapy with S-1 alone or S-1 plus cisplatin for elderly patients with advanced gastric cancer: a multicenter propensity score matched study.

PubMed

Makiyama, Akitaka; Kunieda, Kenji; Noguchi, Masaaki; Kajiwara, Takeshi; Tamura, Takao; Takeda, Koji; Sugiyama, Junko; Minashi, Keiko; Moriwaki, Toshikazu; Sugimoto, Naotoshi; Nagase, Michitaka; Negoro, Yuji; Tsuda, Takashi; Shimodaira, Hideki; Okano, Naohiro; Tsuji, Akihito; Sakai, Daisuke; Yanagihara, Kazuhiro; Ueda, Shinya; Tamura, Shingo; Otsu, Satoshi; Honda, Takuya; Matsushita, Yuzo; Okuno, Tatsuya; Kashiwada, Tomomi; Nozaki, Akira; Ebi, Masahide; Okuda, Hiroyuki; Shimokawa, Mototsugu; Hironaka, Shuichi; Hyodo, Ichinosuke; Baba, Eishi; Boku, Narikazu; Muro, Kei; Esaki, Taito

2018-01-20

Fluoropyrimidine and platinum combination is the standard treatment for advanced or recurrent gastric cancer (AGC). However, fluoropyrimidine monotherapy is commonly used for elderly patients with AGC because of its good tolerability. In this multicenter retrospective study, we collected clinical data of AGC patients aged 70 years or older, treated with S-1 alone or S-1 plus cisplatin (SP) as the first-line treatment between January 2009 and December 2011. Propensity score matched cohorts (PSMC) were used for reducing the confounding effects to compare efficacy and safety between the two treatment groups. Cox regression analysis was performed to clarify the prognostic factors. PSMC (n = 109 in each group) were selected from among 444 eligible patients (S-1 group, 210; SP group, 234); the S-1 group included more patients deemed unfit for intensive chemotherapy than the SP group (e.g., higher age, poorer PS, poor renal function). In the PSMC, patients' characteristics were comparable between groups, except the male ratio (S-1 group, 64.2%; SP group, 77.1%; p = 0.04). No significant differences were observed in either overall survival [hazard ratio (HR) 0.93, p = 0.63] or progression-free survival (HR 1.09, p = 0.61). Severe adverse events (AEs) and hospitalization due to AEs were more frequent in the SP group than in the S-1 group (p < 0.001 each). Our findings do not support the survival benefit of SP over S-1 in elderly patients with AGC. We are now conducting a prospective comparative study to optimize treatment strategy and explore applicability of the geriatric assessment for these patients.

Outcomes of gastrointestinal defect closure with an over-the-scope clip system in a multicenter experience: An analysis of a successful suction method

PubMed Central

Kobara, Hideki; Mori, Hirohito; Fujihara, Shintaro; Nishiyama, Noriko; Chiyo, Taiga; Yamada, Takayoshi; Fujiwara, Masao; Okano, Keiichi; Suzuki, Yasuyuki; Murota, Masayuki; Ikeda, Yoshitaka; Oryu, Makoto; AboEllail, Mohamed; Masaki, Tsutomu

2017-01-01

AIM To demonstrate the clinical outcomes of a multicenter experience and to suggest guidelines for choosing a suction method. METHODS This retrospective study at 5 medical centers involved 58 consecutive patients undergoing over-the-scope clips (OTSCs) placement. The overall rates of technical success (TSR), clinical success (CSR), complications, and procedure time were analyzed as major outcomes. Subsequently, 56 patients, excluding two cases that used the Anchor device, were divided into two groups: 14 cases of simple suction (SS-group) and 42 cases using the Twin Grasper (TG-group). Secondary evaluation was performed to clarify the predictors of OTSC success. RESULTS The TSR, CSR, complication rate, and median procedure time were 89.7%, 84.5%, 1.8%, and 8 (range 1-36) min, respectively, demonstrating good outcomes. However, significant differences were observed between the two groups in terms of the mean procedure time (5.9 min vs 14.1 min). The CSR of the SS- and TG-groups among cases with a maximum defect size ≤ 10 mm and immediate or acute refractory bleeding was 100%, which suggests that SS is a better method than TG in terms of time efficacy. The CSR in the SS-group (78.6%), despite the technical success of the SS method (TSR, 100%), tended to decrease due to delayed leakage compared to that in the TG-group (TSR, CSR; 88.1%), indicating that TG may be desirable for leaks and fistulae with defects of the entire layer. CONCLUSION OTSC system is a safe and effective therapeutic option for gastrointestinal defects. Individualized selection of the suction method based on particular clinical conditions may contribute to the improvement of OTSC success. PMID:28321166

[Confronting the practice of surgery on differentiated thyroid cancer with current guidelines in Germany. A multicenter trial].

PubMed

Schwab, R; Wieler, H; Birtel, S; Ostwald-Lenz, E; Kaiser, K P; Becker, H P

2005-01-01

For the surgical therapy of differentiated thyroid cancer precise guidelines are applied by the German medical societies. In a retrospective multicenter study, we investigated the following issues: Are the current guidelines respected? Is there a difference concerning the surgical radicalism and the outcome? Does the perioperative morbidity increase with the higher radicalism of the procedure? Data gained from 102 patients from 17 regional referral hospitals who underwent surgery for thyroid cancer and a following rodioiodine treatment (mean follow up: 42.7 [24-79] months) were analyzed. At least 71 criterias were analyzed in a SPSS file. 46.1% of carcinomas were incidentally detected during goiter surgery. The thyroid cancer (papillary n = 78; follicular n = 24) occurred in 87% unilateral and in 13% bilateral. Papillary carcinomas < 1 cm were detected in 25 cases; in five of these cases (20%) contralateral carcinomas < 1 cm were found. There were significant differences concerning the surgical radicalism: a range from hemithyroidectomy to radical thyroidectomy with lateral neck dissection. Analysis of the histopathologic reports revealed that lymph node dissection was not performed according to guidelines in 55% of all patients. The perioperative morbidity was lower in departments with a high case load. The postoperative dysfunction of the recurrent laryngeal nerve (mean: 7.9% total / 4.9% nerves at risk) variated highly, depending on differences in radicalism and hospitals. Up to now these variations in surgical treatment have shown no differences in their outcome and survival rates, when followed by radioiodine therapy. Current surgical regimes did not follow the guidelines in more than 50% of all cases. This low acceptance has to be discussed. The actual discussion about principles of treatment regarding, the so-called papillary microcarcinomas (old term) has to be respected within the current guidelines.

Natural History of Malignant Bone Disease in Gastric Cancer: Final Results of a Multicenter Bone Metastasis Survey

PubMed Central

Silvestris, Nicola; Pantano, Francesco; Ibrahim, Toni; Gamucci, Teresa; De Vita, Fernando; Di Palma, Teresa; Pedrazzoli, Paolo; Barni, Sandro; Bernardo, Antonio; Febbraro, Antonio; Satolli, Maria Antonietta; Bertocchi, Paola; Catalano, Vincenzo; Giommoni, Elisa; Comandone, Alessandro; Maiello, Evaristo; Riccardi, Ferdinando; Ferrara, Raimondo; Trogu, Antonio; Berardi, Rossana; Leo, Silvana; Bertolini, Alessandro; Angelini, Francesco; Cinieri, Saverio; Russo, Antonio; Pisconti, Salvatore; Brunetti, Anna Elisabetta; Azzariti, Amalia; Santini, Daniele

2013-01-01

Background Bone metastasis represents an increasing clinical problem in advanced gastric cancer (GC) as disease-related survival improves. In literature, few data on the natural history of bone disease in GC are available. Patients and Methods Data on clinicopathology, skeletal outcomes, skeletal-related events (SREs), and bone-directed therapies for 208 deceased GC patients with evidence of bone metastasis were statistically analyzed. Results Median time to bone metastasis was 8 months (CI 95%, 6.125–9.875 months) considering all included patients. Median number of SREs/patient was one. Less than half of the patients (31%) experienced at least one and only 4 and 2% experienced at least two and three events, respectively. Median times to first and second SRE were 2 and 4 months, respectively. Median survival was 6 months after bone metastasis diagnosis and 3 months after first SRE. Median survival in patients who did not experience SREs was 5 months. Among patients who received zoledronic acid before the first SRE, the median time to appearance of first SRE was significantly prolonged compared to control (7 months vs 4 months for control; P: 0.0005). Conclusions To our knowledge, this retrospective analysis is the largest multicenter study to demonstrate that bone metastases from GC are not so rare, are commonly aggressive and result in relatively early onset of SREs in the majority of patients. Indeed, our large study, which included 90 patients treated with ZOL, showed, for the first time in literature, a significant extension of time to first SRE and increase in the median survival time after diagnosis of bone metastasis. Taken together, these data may support the beneficial effects of ZOL in GC patients. PMID:24204569

Initiation of nutritional support is delayed in critically ill obese patients: a multicenter cohort study.

PubMed

Borel, Anne-Laure; Schwebel, Carole; Planquette, Benjamin; Vésin, Aurélien; Garrouste-Orgeas, Maité; Adrie, Christophe; Clec'h, Christophe; Azoulay, Elie; Souweine, Bertrand; Allaouchiche, Bernard; Goldgran-Toledano, Dany; Jamali, Samir; Darmon, Michael; Timsit, Jean-François

2014-09-01

A high catabolic rate characterizes the acute phase of critical illness. Guidelines recommend an early nutritional support, regardless of the previous nutritional status. We aimed to assess whether the nutritional status of patients, which was defined by the body mass index (BMI) at admission in an intensive care unit (ICU), affected the time of nutritional support initiation. We conducted a cohort study that reported a retrospective analysis of a multicenter ICU database (OUTCOMEREA) by using data prospectively entered from January 1997 to October 2012. Patients who needed orotracheal intubation within the first 72 h and >3 d were included. Data from 3257 ICU stays were analyzed. The delay before feeding was different according to BMI groups (P = 0.035). The delay was longer in obese patients [BMI (in kg/m²) ≥30; n = 663] than in other patients with either low weight (BMI <20; n = 501), normal weight (BMI ≥20 and <25; n = 1135), or overweight (BMI ≥25 and <30; n = 958). The association between nutritional status and a delay in nutrition initiation was independent of potential confounding factors such as age, sex, and diabetes or other chronic diseases. In comparison with normal weight, the adjusted RR (95% CI) associated with a delayed nutrition initiation was 0.92 (0.86, 0.98) for patients with low weight, 1.00 (0.94, 1.05) for overweight patients, and 1.06 (1.00, 1.12) for obese patients (P = 0.004). The initiation of nutritional support was delayed in obese ICU patients. Randomized controlled trials that address consequences of early compared with delayed beginnings of nutritional support in critically ill obese patients are needed. © 2014 American Society for Nutrition.

Stereotactic Radiosurgery for Cushing Disease: Results of an International, Multicenter Study.

PubMed

Mehta, Gautam U; Ding, Dale; Patibandla, Mohana Rao; Kano, Hideyuki; Sisterson, Nathaniel; Su, Yan-Hua; Krsek, Michal; Nabeel, Ahmed M; El-Shehaby, Amr; Kareem, Khaled A; Martinez-Moreno, Nuria; Mathieu, David; McShane, Brendan; Blas, Kevin; Kondziolka, Douglas; Grills, Inga; Lee, John Y; Martinez-Alvarez, Roberto; Reda, Wael A; Liscak, Roman; Lee, Cheng-Chia; Lunsford, L Dade; Vance, Mary Lee; Sheehan, Jason P

2017-11-01

Cushing disease (CD) due to adrenocorticotropic hormone-secreting pituitary tumors can be a management challenge. To better understand the outcomes of stereotactic radiosurgery (SRS) for CD and define its role in management. International, multicenter, retrospective cohort analysis. Ten medical centers participating in the International Gamma Knife Research Foundation. Patients with CD with >6 months endocrine follow-up. SRS using Gamma Knife radiosurgery. The primary outcome was control of hypercortisolism (defined as normalization of free urinary cortisol). Radiologic response and adverse radiation effects (AREs) were recorded. In total, 278 patients met inclusion criteria, with a mean follow-up of 5.6 years (0.5 to 20.5 years). Twenty-two patients received SRS as a primary treatment of CD. Mean margin dose was 23.7 Gy. Cumulative initial control of hypercortisolism was 80% at 10 years. Mean time to cortisol normalization was 14.5 months. Recurrences occurred in 18% with initial cortisol normalization. Overall, the rate of durable control of hypercortisolism was 64% at 10 years and 68% among patients who received SRS as a primary treatment. AREs included hypopituitarism (25%) and cranial neuropathy (3%). Visual deficits were related to treatment of tumor within the suprasellar cistern (P = 0.01), whereas both visual (P < 0.0001) and nonvisual cranial neuropathy (P = 0.02) were related to prior pituitary irradiation. SRS for CD is well tolerated and frequently results in control of hypercortisolism. However, recurrences can occur. SRS should be considered for patients with persistent hypercortisolism after pituitary surgery and as a primary treatment in those unfit for surgery. Long-term endocrine follow-up is essential after SRS. Copyright © 2017 Endocrine Society

Multicenter Evaluation of Octreotide as Secondary Prophylaxis in Patients With Left Ventricular Assist Devices and Gastrointestinal Bleeding.

PubMed

Shah, Keyur B; Gunda, Sampath; Emani, Sitaramesh; Kanwar, Manreet K; Uriel, Nir; Colombo, Paolo C; Uber, Patricia A; Sears, Melissa L; Chuang, Joyce; Farrar, David J; Brophy, Donald F; Smallfield, George B

2017-11-01

Gastrointestinal (GI) bleeding is one of the most common complications after continuous-flow left ventricular assist device implantation. More than one third of patients with incident bleed go on to develop recurrent GI bleeding. Octreotide, a somatostatin analog, is proposed to reduce the risk of recurrent GI bleeding in this population. This multicenter, retrospective analysis evaluated 51 continuous-flow left ventricular assist device patients who received secondary prophylaxis with octreotide after their index GI bleed from 2009 to 2015. All patients had a hospitalization for GI bleed and received octreotide after discharge. Patient demographics, medical and medication history, and clinical characteristics of patients who rebled after receiving octreotide were compared with non-rebleeders. These data were also compared with matched historical control patients previously enrolled in the HMII (HeartMate II) clinical trials, none of whom received octreotide, to provide a context for the bleeding rates. Twelve patients (24%) who received secondary octreotide prophylaxis developed another GI bleed, whereas 39 (76%) did not. There were similar intergroup demographics; however, significantly more bleeders had a previous GI bleeding history before left ventricular assist device placement (33% versus 5%; P =0.02) and greater frequency of angiodysplasia confirmed during endoscopy (58% versus 23%; P =0.03). Fewer patients in this study experienced a recurrent GI bleed compared with a matched historical control group that did not receive octreotide (24% versus 43%; P =0.04). Patients with continuous-flow left ventricular assist device receiving secondary prophylaxis with octreotide had a significantly lower GI bleed recurrence compared with historical controls not treated with octreotide. Additional prospective studies are needed to confirm these data. © 2017 American Heart Association, Inc.

Clinical presentation and visual status of retinitis pigmentosa patients: a multicenter study in southwestern Nigeria.

PubMed

Onakpoya, Oluwatoyin Helen; Adeoti, Caroline Olufunlayo; Oluleye, Tunji Sunday; Ajayi, Iyiade Adeseye; Majengbasan, Timothy; Olorundare, Olayemi Kolawole

2016-01-01

To review the visual status and clinical presentation of patients with retinitis pigmentosa (RP). Multicenter, retrospective, and analytical review was conducted of the visual status and clinical characteristics of patients with RP at first presentation from January 2007 to December 2011. Main outcome measure was the World Health Organization's visual status classification in relation to sex and age at presentation. Data analysis by SPSS (version 15) and statistical significance was assumed at P<0.05. One hundred and ninety-two eyes of 96 patients with mean age of 39.08±18.5 years and mode of 25 years constituted the study population; 55 (57.3%) were males and 41 (42.7%) females. Loss of vision 67 (69.8%) and night blindness 56 (58.3%) were the leading symptoms. Twenty-one (21.9%) patients had a positive family history, with RP present in their siblings 15 (71.4%), grandparents 11 (52.3%), and parents 4 (19.4%). Forty (41.7%) were blind at presentation and 23 (24%) were visually impaired. Blindness in six (15%) patients was secondary to glaucoma. Retinal vascular narrowing and retinal pigmentary changes of varying severity were present in all patients. Thirty-five (36.5%) had maculopathy, 36 (37.5%) refractive error, 19 (20%) lenticular opacities, and eleven (11.5%) had glaucoma. RP was typical in 85 patients (88.5%). Older patients had higher rates of blindness at presentation (P=0.005); blindness and visual impairment rate at presentation were higher in males than females (P=0.029). Clinical presentation with advanced diseases, higher blindness rate in older patients, sex-related difference in blindness/visual impairment rates, as well as high glaucoma blindness in RP patients requires urgent attention in southwestern Nigeria.

Development, implementation, and compliance of treatment pathways in radiation medicine.

PubMed

Potters, Louis; Raince, Jadeep; Chou, Henry; Kapur, Ajay; Bulanowski, Daniel; Stanzione, Regina; Lee, Lucille

2013-01-01

While much emphasis on safety in the radiation oncology clinic is placed on process, there remains considerable opportunity to increase safety, enhance outcomes, and avoid ad hoc care by instituting detailed treatment pathways. The purpose of this study was to review the process of developing evidence and consensus-based, outcomes-oriented treatment pathways that standardize treatment and patient management in a large multi-center radiation oncology practice. Further, we reviewed our compliance in incorporating these directives into our day-to-day clinical practice. Using the Institute of Medicine guideline for developing treatment pathways, 87 disease specific pathways were developed and incorporated into the electronic medical system in our multi-facility radiation oncology department. Compliance in incorporating treatment pathways was assessed by mining our electronic medical records (EMR) data from January 1, 2010 through February 2012 for patients with breast and prostate cancer. This retrospective analysis of data from EMR found overall compliance to breast and prostate cancer treatment pathways to be 97 and 99%, respectively. The reason for non-compliance proved to be either a failure to complete the prescribed care based on grade II or III toxicity (n = 1 breast, 3 prostate) or patient elected discontinuance of care (n = 1 prostate) or the physician chose a higher dose for positive/close margins (n = 3 breast). This study demonstrates that consensus and evidence-based treatment pathways can be developed and implemented in a multi-center department of radiation oncology. And that for prostate and breast cancer there was a high degree of compliance using these directives. The development and implementation of these pathways serve as a key component of our safety program, most notably in our effort to facilitate consistent decision-making and reducing variation between physicians.

A multicenter study of primary brain tumor incidence in Australia (2000–2008)

PubMed Central

Dobes, Martin; Shadbolt, Bruce; Khurana, Vini G.; Jain, Sanjiv; Smith, Sarah F.; Smee, Robert; Dexter, Mark; Cook, Raymond

2011-01-01

There are conflicting reports from Europe and North America regarding trends in the incidence of primary brain tumor, whereas the incidence of primary brain tumors in Australia is currently unknown. We aimed to determine the incidence in Australia with age-, sex-, and benign-versus-malignant histology-specific analyses. A multicenter study was performed in the state of New South Wales (NSW) and the Australian Capital Territory (ACT), which has a combined population of >7 million with >97% rate of population retention for medical care. We retrospectively mined pathology databases servicing neurosurgical centers in NSW and ACT for histologically confirmed primary brain tumors diagnosed from January 2000 through December 2008. Data were weighted for patient outflow and data completeness. Incidence rates were age standardized and trends analyzed using joinpoint analysis. A weighted total of 7651 primary brain tumors were analyzed. The overall US-standardized incidence of primary brain tumors was 11.3 cases 100 000 person-years (±0.13; 95% confidence interval, 9.8–12.3) during the study period with no significant linear increase. A significant increase in primary malignant brain tumors from 2000 to 2008 was observed; this appears to be largely due to an increase in malignant tumor incidence in the ≥65-year age group. This collection represents the most contemporary data on primary brain tumor incidence in Australia. Whether the observed increase in malignant primary brain tumors, particularly in persons aged ≥65 years, is due to improved detection, diagnosis, and care delivery or a true change in incidence remains undetermined. We recommend a direct, uniform, and centralized approach to monitoring primary brain tumor incidence that can be independent of multiple interstate cancer registries. PMID:21727214

Safety and Efficacy of Defibrillator Charging During Ongoing Chest Compressions: A Multicenter Study

PubMed Central

Edelson, Dana P.; Robertson-Dick, Brian J.; Yuen, Trevor C.; Eilevstjønn, Joar; Walsh, Deborah; Bareis, Charles J.; Vanden Hoek, Terry L.; Abella, Benjamin S.

2013-01-01

BACKGROUND Pauses in chest compressions during cardiopulmonary resuscitation have been shown to correlate with poor outcomes. In an attempt to minimize these pauses, the American Heart Association recommends charging the defibrillator during chest compressions. While simulation work suggests decreased pause times using this technique, little is known about its use in clinical practice. METHODS We conducted a multicenter, retrospective study of defibrillator charging at three US academic teaching hospitals between April 2006 and April 2009. Data were abstracted from CPR-sensing defibrillator transcripts. Pre-shock pauses and total hands- off time preceding the defibrillation attempts were compared among techniques. RESULTS A total of 680 charge-cycles from 244 cardiac arrests were analyzed. The defibrillator was charged during ongoing chest compressions in 448 (65.9%) instances with wide variability across the three sites. Charging during compressions correlated with a decrease in median pre-shock pause [2.6 (IQR 1.9–3.8) vs 13.3 (IQR 8.6–19.5) s; p < 0.001] and total hands-off time in the 30 s preceding defibrillation [10.3 (IQR 6.4–13.8) vs 14.8 (IQR 11.0–19.6) s; p < 0.001]. The improvement in hands-off time was most pronounced when rescuers charged the defibrillator in anticipation of the pause, prior to any rhythm analysis. There was no difference in inappropriate shocks when charging during chest compressions (20.0 vs 20.1%; p=0.97) and there was only one instance noted of inadvertent shock administration during compressions, which went unnoticed by the compressor. CONCLUSIONS Charging during compressions is underutilized in clinical practice. The technique is associated with decreased hands-off time preceding defibrillation, with minimal risk to patients or rescuers. PMID:20807672

A French multicenter study of over 700 patients with 22q11 deletions diagnosed using FISH or aCGH.

PubMed

Poirsier, Céline; Besseau-Ayasse, Justine; Schluth-Bolard, Caroline; Toutain, Jérôme; Missirian, Chantal; Le Caignec, Cédric; Bazin, Anne; de Blois, Marie Christine; Kuentz, Paul; Catty, Marie; Choiset, Agnès; Plessis, Ghislaine; Basinko, Audrey; Letard, Pascaline; Flori, Elisabeth; Jimenez, Mélanie; Valduga, Mylène; Landais, Emilie; Lallaoui, Hakima; Cartault, François; Lespinasse, James; Martin-Coignard, Dominique; Callier, Patrick; Pebrel-Richard, Céline; Portnoi, Marie-France; Busa, Tiffany; Receveur, Aline; Amblard, Florence; Yardin, Catherine; Harbuz, Radu; Prieur, Fabienne; Le Meur, Nathalie; Pipiras, Eva; Kleinfinger, Pascale; Vialard, François; Doco-Fenzy, Martine

2016-06-01

Although 22q11.2 deletion syndrome (22q11.2DS) is the most recurrent human microdeletion syndrome associated with a highly variable phenotype, little is known about the condition's true incidence and the phenotype at diagnosis. We performed a multicenter, retrospective analysis of postnatally diagnosed patients recruited by members of the Association des Cytogénéticiens de Langue Française (the French-Speaking Cytogeneticists Association). Clinical and cytogenetic data on 749 cases diagnosed between 1995 and 2013 were collected by 31 French cytogenetics laboratories. The most frequent reasons for referral of postnatally diagnosed cases were a congenital heart defect (CHD, 48.6%), facial dysmorphism (49.7%) and developmental delay (40.7%). Since 2007 (the year in which array comparative genomic hybridization (aCGH) was introduced for the routine screening of patients with intellectual disability), almost all cases have been diagnosed using FISH (96.1%). Only 15 cases (all with an atypical phenotype) were diagnosed with aCGH; the deletion size ranged from 745 to 2904 kb. The deletion was inherited in 15.0% of cases and was of maternal origin in 85.5% of the latter. This is the largest yet documented cohort of patients with 22q11.2DS (the most commonly diagnosed microdeletion) from the same population. French cytogenetics laboratories diagnosed at least 108 affected patients (including fetuses) per year from among a national population of ∼66 million. As observed for prenatal diagnoses, CHDs were the most frequently detected malformation in postnatal diagnoses. The most common CHD in postnatal diagnoses was an isolated septal defect.

Multicenter external validation of two malignancy risk prediction models in patients undergoing 18F-FDG-PET for solitary pulmonary nodule evaluation.

PubMed

Perandini, Simone; Soardi, G A; Larici, A R; Del Ciello, A; Rizzardi, G; Solazzo, A; Mancino, L; Zeraj, F; Bernhart, M; Signorini, M; Motton, M; Montemezzi, S

2017-05-01

To achieve multicentre external validation of the Herder and Bayesian Inference Malignancy Calculator (BIMC) models. Two hundred and fifty-nine solitary pulmonary nodules (SPNs) collected from four major hospitals which underwent 18-FDG-PET characterization were included in this multicentre retrospective study. The Herder model was tested on all available lesions (group A). A subgroup of 180 SPNs (group B) was used to provide unbiased comparison between the Herder and BIMC models. Receiver operating characteristic (ROC) area under the curve (AUC) analysis was performed to assess diagnostic accuracy. Decision analysis was performed by adopting the risk threshold stated in British Thoracic Society (BTS) guidelines. Unbiased comparison performed In Group B showed a ROC AUC for the Herder model of 0.807 (95 % CI 0.742-0.862) and for the BIMC model of 0.822 (95 % CI 0.758-0.875). Both the Herder and the BIMC models were proven to accurately predict the risk of malignancy when tested on a large multicentre external case series. The BIMC model seems advantageous on the basis of a more favourable decision analysis. • The Herder model showed a ROC AUC of 0.807 on 180 SPNs. • The BIMC model showed a ROC AUC of 0.822 on 180 SPNs. • Decision analysis is more favourable to the BIMC model.

Upper Gastrointestinal Bleeding in Chinese Children: A Multicenter 10-Year Retrospective Study.

PubMed

Yu, Yi; Wang, Baoxiang; Yuan, Lan; Yang, Hui; Wang, Xinqiong; Xiao, Yuan; Mei, Hong; Xu, Chundi

2016-08-01

Objective This study aims to analyze the clinical and endoscopic presentations of upper gastrointestinal bleeding (UGIB) in the Chinese children. Methods A 10-year retrospective study was made on children with UGIB and undertaken esophagogastroduodenoscopy (EGD) from 4 tertiary referral centers in China. Results Of the 1218 children studied, the bleeding source was found in 76.4%. Erosive gastritis was the most common endoscopic finding (33.5%), followed by duodenal ulcer (23.2%). The proportion of erosive gastritis decreased with age (correlation coefficient = -0.787), and duodenal ulcer increased with age (correlation coefficient = 0.958). The bleeding source was more likely to be determined in children having EGDs within 48 hours (80.6% vs 67.9%). Conclusions In Chinese children with UGIB, erosive gastritis and duodenal ulcer were the leading causes, and their proportions varied with age. EGDs performed within 48 hours may improve the possibility of finding the source of bleeding. © The Author(s) 2015.

Survival of multiple myeloma patients aged 65-70 years in the era of novel agents and autologous stem cell transplantation. A multicenter retrospective collaborative study of the Japanese Society of Myeloma and the European Myeloma Network.

PubMed

Ozaki, Shuji; Harada, Takeshi; Saitoh, Takayuki; Shimazaki, Chihiro; Itagaki, Mitsuhiro; Asaoku, Hideki; Kuroda, Yoshiaki; Chou, Takaaki; Yoshiki, Yumiko; Suzuki, Kenshi; Murakami, Hirokazu; Hayashi, Kunihiko; Mina, Roberto; Palumbo, Antonio; Shimizu, Kazuyuki

2014-01-01

Novel agents such as thalidomide, lenalidomide and bortezomib have dramatically changed the treatment paradigm of multiple myeloma (MM). However, it is not clear whether these agents improve the prognosis of elderly patients who have undergone autologous stem cell transplantation (auto-SCT). We retrospectively analyzed the outcome of 318 newly diagnosed patients aged 65–70 years who were treated between January 1, 2004, and December 31, 2009. As initial therapy, 192 patients were treated with conventional chemotherapy,88 with novel agent-containing regimens, 21 with conventional chemotherapy plus auto-SCT and the remaining 17 with novel agents plus auto-SCT. The median progression-free survival was 19.1, 24.5, 26.8 and 35.2 months, respectively, and the 5-year overall survival (OS) was 40, 62, 63 and 87%, respectively. Initial therapy with novel agents (p < 0.001) or auto-SCT (p < 0.02) significantly improved OS compared with the group without these treatment modalities. Salvage therapy with novel agents also significantly improved survival after relapse compared with conventional chemotherapy alone (p < 0.04). In a multivariate analysis, the use of novel agents was an independent prognostic factor significantly associated with extended OS(p < 0.003). These results indicate that novel agents and auto-SCT had a major impact on OS in eligible patients in this subgroup of MM. © 2014 S. Karger AG, Basel

[Fetal bradycardia: a retrospective study in 9 Spanish centers].

PubMed

Perin, F; Rodríguez Vázquez del Rey, M M; Deiros Bronte, L; Ferrer Menduiña, Q; Rueda Nuñez, F; Zabala Arguelles, J I; García de la Calzada, D; Teodoro Marin, S; Centeno Malfaz, F; Galindo Izquierdo, A

2014-11-01

The aim of this study is to review the current management and outcomes of fetal bradycardia in 9 Spanish centers. Retrospective multicenter study: analysis of all fetuses with bradycardia diagnosed between January 2008 and September 2010. Underlying mechanisms of fetal bradyarrhythmias were studied with echocardiography. A total of 37 cases were registered: 3 sinus bradycardia, 15 blocked atrial bigeminy, and 19 high grade atrioventricular blocks. Sinus bradycardia: 3 cases (100%) were associated with serious diseases. Blocked atrial bigeminy had an excellent outcome, except for one case with post-natal tachyarrhythmia. Of the atrioventricular blocks, 16% were related to congenital heart defects with isomerism, 63% related to the presence of maternal SSA/Ro antibodies, and 21% had unclear etiology. Overall mortality was 20% (37%, if terminations of pregnancy are taken into account). Risk factors for mortality were congenital heart disease, hydrops and/or ventricular dysfunction. Management strategies differed among centers. Steroids were administrated in 73% of immune-mediated atrioventricular blocks, including the only immune-mediated IInd grade block. More than half (58%) of atrioventricular blocks had a pacemaker implanted in a follow-up of 18 months. Sustained fetal bradycardia requires a comprehensive study in all cases, including those with sinus bradycardia. Blocked atrial bigeminy has a good prognosis, but tachyarrhythmias may develop. Heart block has significant mortality and morbidity rates, and its management is still highly controversial. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

Reduced incidence of lung cancer in patients with idiopathic pulmonary fibrosis treated with pirfenidone.

PubMed

Miura, Yukiko; Saito, Takefumi; Tanaka, Toru; Takoi, Hiroyuki; Yatagai, Yohei; Inomata, Minoru; Nei, Takahito; Saito, Yoshinobu; Gemma, Akihiko; Azuma, Arata

2018-01-01

Idiopathic pulmonary fibrosis (IPF) is a disease with a worse prognosis than some types of cancer. In patients with IPF, lung cancer is critical because of the associated high mortality rate from its progression and fatal complications from anticancer treatments. Therefore, preventing lung cancer in patients with IPF is primordial. Pirfenidone is an anti-fibrotic agent that reduces the decline in forced vital capacity. This study aimed to assess the effect of pirfenidone in the development of lung cancer in patients with IPF. Data from 261 patients with IPF with and without pirfenidone were retrospectively reviewed, and the incidence of lung cancer was analyzed. In the pirfenidone group, the incidence of lung cancer was significantly lower than in the non-pirfenidone group (2.4% vs. 22.0%, P < 0.0001). Multivariate Cox proportional hazards regression analysis demonstrated that pirfenidone decreased the risk of lung cancer (hazard ratio, 0.11; 95% confidence interval, 0.03 to 0.46; P = 0.003), whereas coexisting emphysema increased the incidence of lung cancer (hazard ratio, 3.22; 95% confidence interval, 1.35 to 7.70; P = 0.009). Pirfenidone might correlate with a decreased risk of lung cancer in patients with IPF. However, no definite conclusion can be drawn from this retrospective study, and a multicenter, prospective cohort study is still warranted to confirm the effect of pirfenidone on lung cancer in patients with IPF. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

A multicenter study shows PTEN deletion is strongly associated with seminal vesicle involvement and extracapsular extension in localized prostate cancer

PubMed Central

Troyer, Dean A; Jamaspishvili, Tamara; Wei, Wei; Feng, Ziding; Good, Jennifer; Hawley, Sarah; Fazli, Ladan; McKenney, Jesse K; Simko, Jeff; Hurtado-Coll, Antonio; Carroll, Peter R; Gleave, Martin; Lance, Raymond; Lin, Daniel W; Nelson, Peter S; Thompson, Ian M; True, Lawrence D; Brooks, James D; Squire, Jeremy A

2015-01-01

BACKGROUND Loss of the phosphatase and tensin homolog (PTEN) tumor suppressor gene is a promising marker of aggressive prostate cancer. Active surveillance and watchful waiting are increasingly recommended to patients with small tumors felt to be low risk, highlighting the difficulties of Gleason scoring in this setting. There is an urgent need for predictive biomarkers that can be rapidly deployed to aid in clinical decision-making. Our objectives were to assess the incidence and ability of PTEN alterations to predict aggressive disease in a multicenter study. METHODS We used recently developed probes optimized for sensitivity and specificity in a four-color FISH deletion assay to study the Canary Retrospective multicenter Prostate Cancer Tissue Microarray (TMA). This TMA was constructed specifically for biomarker validation from radical prostatectomy specimens, and is accompanied by detailed clinical information with long-term follow-up. RESULTS In 612 prostate cancers, the overall rate of PTEN deletion was 112 (18.3%). Hemizygous PTEN losses were present in 55/612 (9.0%) of cancers, whereas homozygous PTEN deletion was observed in 57/612 (9.3%) of tumors. Significant associations were found between PTEN status and pathologic stage (P < 0.0001), seminal vesicle invasion (P = 0.0008), extracapsular extension (P < 0.0001), and Gleason score (P = 0.0002). In logistic regression analysis of clinical and pathological variables, PTEN deletion was significantly associated with extracapsular extension, seminal vesicle involvement, and higher Gleason score. In the 406 patients in which clinical information was available, PTEN homozygous (P = 0.009) deletion was associated with worse post-operative recurrence-free survival (number of events = 189), pre-operative prostate specific antigen (PSA) (P < 0.001), and pathologic stage (P = 0.03). CONCLUSION PTEN status assessed by FISH is an independent predictor for recurrence-free survival in multivariate models, as were seminal vesicle invasion, extracapsular extension, and Gleason score, and preoperative PSA. Furthermore, these data demonstrate that the assay can be readily introduced at first diagnosis in a cost effective manner analogous to the use of FISH for analysis of HER2/neu status in breast cancer. Combined with published research beginning 17 years ago, both the data and tools now exist to implement a PTEN assay in the clinic. Prostate 75: 1206–1215, 2015. © 2015 The Authors. The Prostate, published by Wiley Periodicals, Inc. PMID:25939393

Prognostic Score of Long-Term Survival After Surgery for Malignant Pleural Mesothelioma: A Multicenter Analysis.

PubMed

Leuzzi, Giovanni; Rea, Federico; Spaggiari, Lorenzo; Marulli, Giuseppe; Sperduti, Isabella; Alessandrini, Gabriele; Casiraghi, Monica; Bovolato, Pietro; Pariscenti, Gianluca; Alloisio, Marco; Infante, Maurizio; Pagan, Vittore; Fontana, Paolo; Oliaro, Alberto; Ruffini, Enrico; Ratto, Giovanni Battista; Leoncini, Giacomo; Sacco, Rocco; Mucilli, Felice; Facciolo, Francesco

2015-09-01

Despite ongoing efforts to improve therapy in malignant pleural mesothelioma, few patients undergoing extrapleural pneumonectomy experience long-term survival (LTS). This study aims to explore predictors of LTS after extrapleural pneumonectomy and to define a prognostic score. From January 2000 to December 2010, we retrospectively reviewed clinicopathologic and oncological factors in a multicenter cohort of 468 malignant pleural mesothelioma patients undergoing extrapleural pneumonectomy. LTS was defined as survival longer than 3 years. Associations were evaluated using χ(2), Student's t, and Mann-Whitney U tests. Logistic regression, Cox regression hazard model, and bootstrap analysis were applied to identify outcome predictors. Survival curves were calculated by the Kaplan-Meier method. Receiver operating characteristic analyses were used to estimate optimal cutoff and area under the curve for accuracy of the model. Overall, 107 patients (22.9%) survived at least 3 years. Median overall, cancer-specific, and disease-free survival times were 60 (95% confidence interval [CI], 51 to 69), 63 (95% CI, 54 to 72), and 49 months (95% CI, 39 to 58), respectively. At multivariate analysis, age (odds ratio, 0.51; 95% CI, 0.31 to 0.82), epithelioid histology (odds ratio, 7.07; 95% CI, 1.56 to 31.93), no history of asbestos exposure (odds ratio, 3.13; 95% CI, 1.13 to 8.66), and the ratio between metastatic and resected lymph nodes less than 22% (odds ratio, 4.12; 95% CI, 1.68 to 10.12) were independent predictors of LTS. According to these factors, we created a scoring system for LTS that allowed us to correctly predict overall, cancer-specific, and disease-free survival in the total sample, obtaining two different groups with favorable or poor prognosis (area under the curve, 0.74; standard error, 0.04; p < 0.0001). Our prognostic model facilitates the prediction of LTS after surgery for malignant pleural mesothelioma and can help to stratify the outcome and, eventually, tailor postoperative treatment. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Computed tomography angiography spot sign predicts intraprocedural aneurysm rupture in subarachnoid hemorrhage.

PubMed

Burkhardt, Jan-Karl; Neidert, Marian Christoph; Stienen, Martin Nikolaus; Schöni, Daniel; Fung, Christian; Roethlisberger, Michel; Corniola, Marco Vincenzo; Bervini, David; Maduri, Rodolfo; Valsecchi, Daniele; Tok, Sina; Schatlo, Bawarjan; Bijlenga, Philippe; Schaller, Karl; Bozinov, Oliver; Regli, Luca

2017-07-01

To analyze whether the computed tomography angiography (CTA) spot sign predicts the intraprocedural rupture rate and outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). From a prospective nationwide multicenter registry database, 1023 patients with aneurysmal subarachnoid hemorrhage (aSAH) were analyzed retrospectively. Descriptive statistics and logistic regression analysis were used to compare spot sign-positive and -negative patients with aneurysmal intracerebral hemorrhage (aICH) for baseline characteristics, aneurysmal and ICH imaging characteristics, treatment and admission status as well as outcome at discharge and 1-year follow-up (1YFU) using the modified Rankin Scale (mRS). A total of 218 out of 1023 aSAH patients (21%) presented with aICH including 23/218 (11%) patients with spot sign. Baseline characteristics were comparable between spot sign-positive and -negative patients. There was a higher clip-to-coil ratio in patients with than without aICH (both spot sign positive and negative). Median aICH volume was significantly higher in the spot sign-positive group (50 ml, 13-223 ml) than in the spot sign-negative group (18 ml, 1-416; p < 0.0001). Patients with a spot sign-positive aICH thus were three times as likely as those with spot sign-negative aICH to show an intraoperative aneurysm rupture [odds ratio (OR) 3.04, 95% confidence interval (CI) 1.04-8.92, p = 0.046]. Spot sign-positive aICH patients showed a significantly worse mRS at discharge (p = 0.039) than patients with spot sign-negative aICH (median mRS 5 vs. 4). Logistic regression analysis showed that the spot sign was an aICH volume-dependent predictor for outcome. Both spot sign-positive and -negative aICH patients showed comparable rates of hospital death, death at 1YFU and mRS at 1YFU. In this multicenter data analysis, patients with spot sign-positive aICH showed higher aICH volumes and a higher rate of intraprocedural aneurysm rupture, but comparable long-term outcome to spot sign-negative aICH patients.

Analysis of Maternal Risk Factors Associated With Congenital Vertebral Malformations

PubMed Central

Hesemann, Jennifer; Lauer, Emily; Ziska, Stephen; Noonan, Kenneth; Nemeth, Blaise; Scott-Schwoerer, Jessica; McCarty, Catherine; Rasmussen, Kristen; Goldberg, Jacob M.; Sund, Sarah; Eickhoff, Jens; Raggio, Cathleen L.; Giampietro, Philip F.

2014-01-01

Study Design A retrospective chart review of cases with congenital vertebral malformations (CVM) and controls with normal spine morphology. Objective To determine the relative contribution of maternal environmental factors (MEF) during pregnancy including maternal insulin dependent diabetes mellitus, valproic acid, alcohol, smoking, hyperthermia, twin gestation, assisted reproductive technology, in-vitro fertilization and maternal clomiphene usage to CVM development. Summary of Background Data Congenital vertebral malformations (CVM) represent defects in formation and segmentation of somites occurring with an estimated incidence of between 0.13–0.50 per 1000 live births. CVM may be associated with congenital scoliosis, Klippel-Feil syndrome, hemifacial microsomia and VACTERL syndromes, and represent significant morbidity due to pain and cosmetic disfigurement. Methods A multicenter retrospective chart review of 229 cases with CVM and 267 controls with normal spine morphology between the ages of 1–50 years was performed in order to obtain the odds ratio (OR) of MEF related to CVM among cases vs. controls. CVM due to an underlying syndrome associated with a known gene mutation or chromosome etiology were excluded. An imputation based analysis was performed in which subjects with no documentation of MEF history were treated as no maternal exposure.” Univariate and multivariate analysis was conducted to calculate the OR. Results Of the 229 total cases, 104 cases had single or multiple CVM without additional congenital malformations (CM) (Group 1) and 125 cases had single or multiple CVM and additional CM (Group 2). Nineteen percent of total cases had an identified MEF. The OR (95% CI, P-value) for MEF history for Group 1 was 6.0 (2.4–15.1, P<0.001) in the univariate analysis. The OR for MEF history in Group 2 was 9.1 (95%CI, P-value) (3.8–21.6, P<0.001) in the univariate analysis. The results were confirmed in the multivariate analysis, after adjusting for age, gender, and institution. Discussion These results support a hypothesis for an association between the above MEF during pregnancy and CVM and have implications for development of prevention strategies. Further prospective studies are needed to quantify association between CVM and specific MEF. PMID:23446706

Incidence and Risk Factors of Subsequent Hip Fractures in Korea: Multicenter Study

PubMed Central

2014-01-01

This study analyzes the incidence of subsequent hip fractures and its risk factors in the northwestern region of Korea. We analyzed hip fracture patients who visited any of the 5 teaching hospitals in the Bucheon and Incheon area from January 2000 to December 2010. Medical records were reviewed and presence of subsequent hip fractures, alcohol history, marital status, live in solitude, dementia, dizziness, American society of anesthesiologists score, osteoporosis treatment after fracture, body mass index (BMI) and initial bone mineral density were analyzed. The average follow-up period was 12 months (range 1-130 months). A total of 2,546 patients (women 1,770, men 776) who had experienced hip fractures were included. Of these, subsequent hip fractures were found in 233 patients (9.2%) (women 187, men 46). Mean age at the time of the first fracture was 79.2 yr old (range 50-100 yr). The average interval between the first fracture and the subsequent hip fractures was 30.2 months (range 4 days-154 months). In this large-scale, retrospective, multicenter study, overall incidence of subsequent hip fractures is 9.2%. Independent risk factors of subsequent fracture are women, BMI<22 kg/m2, and being unmarried. PMID:25045233

Surpassing the Target: How a Recruitment Campaign Transformed the Participant Accrual Trajectory in the Epilepsy Phenome/Genome Project.

PubMed

McGovern, Kathleen; Karn, Catharine Freyer; Fox, Kristen

2015-10-01

Participant recruitment challenges pervade the majority of publicly funded clinical trials. However, little is known about methods for enhancing participant accrual. The Epilepsy Phenome/Genome Project (EPGP), a multicenter study funded by the National Institute of Neurological Disorders and Stroke (NINDS), aimed to enroll a total of 5,250 participants to better understand the genetic causes and phenotypic manifestations of epilepsy. However, similar to other trials, EPGP encountered recruitment challenges, and by the end of its first year, net enrollment was only 48% of the target for that time. To address this, EPGP established a National Participant Recruitment Campaign and began implementing and tracking the enrollment outcomes of a variety of proven and relatively novel recruitment methods. At the conclusion of the project, EPGP had successfully enrolled a total of 5,445 participants, thus surpassing its enrollment target. Data pertaining to EPGP's National Participant Recruitment Campaign was analyzed retrospectively, and the results are reported here, so that other multicenter trials may consider these methods in their recruitment planning and potentially avoid the costly repercussions of participant accrual issues. © 2015 Wiley Periodicals, Inc.

Implantable electrical bone stimulation for arthrodeses of the foot and ankle in high-risk patients: a multicenter study.

PubMed

Saxena, Amol; DiDomenico, Lawrence A; Widtfeldt, Arthur; Adams, Todd; Kim, Will

2005-01-01

This study assessed arthrodesis procedures performed in the foot and ankle of high-risk patients following implantation of an internal electrical bone stimulator. Criteria defining patients as "high risk" included diabetes, obesity, habitual tobacco and/or alcohol use, immunosuppressive therapy, and previous history of nonunion. Standard arthrodesis protocol of bone graft and internal fixation was supplemented with the implantable electrical bone stimulator. A retrospective, multicenter review was conducted of 26 patients (28 cases) who underwent 28 forefoot and hindfoot arthrodeses from 1998 to 2002. Complete fusion was defined as bony trabeculation across the joint, lack of motion across the joint, maintenance of hardware/fixation, and absence of radiographic signs of nonunion or pseudoarthrosis. Radiographic consolidation was achieved in 24 of the 28 cases at an average 10.3+/-4.0 weeks. Followup averaged 27.2 months. Complications included 2 patients who sustained breakage of the cables to the bone stimulator. Five patients underwent additional surgery. Four of the 5 patients had additional surgery in order to achieve arthrodesis. All 4 went on to subsequent arthrodesis. This study demonstrates how arthrodesis of the foot and ankle may be enhanced by the use of implantable electrical bone stimulation.

Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial.

PubMed

Dominguez-Rodriguez, Alberto; Burillo-Putze, Guillermo; Garcia-Saiz, Maria Del Mar; Aldea-Perona, Ana; Harmand, Magali González-Colaço; Mirò, Oscar; Abreu-Gonzalez, Pedro

2017-04-01

Morphine has been used for several decades in cases of acute pulmonary edema (APE) due to the anxiolytic and vasodilatory properties of the drug. The non-specific depression of the central nervous system is probably the most significant factor for the changes in hemodynamics in APE. Retrospective studies have shown both negative and neutral effects in patients with APE and therefore some authors have suggested benzodiazepines as an alternative treatment. The use of intravenous morphine in the treatment of APE remains controversial. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE. The MIMO trial will evaluate as a primary endpoint whether intravenous morphine administration improves clinical outcomes defined as in-hospital mortality. Secondary endpoint evaluation will be mechanical ventilation, cardiopulmonary resuscitation, intensive care unit admission rate, intensive care unit length of stay, and hospitalization length. In the emergency department, morphine is still used for APE in spite of poor scientific background data. The data from the MIMO trial will establish the effect-and especially the risk-when using morphine for APE.

In vivo measurements of proton relaxation times in human brain, liver, and skeletal muscle: a multicenter MRI study.

PubMed

de Certaines, J D; Henriksen, O; Spisni, A; Cortsen, M; Ring, P B

1993-01-01

Quantitative magnetic resonance imaging may offer unique potential for tissue characterization in vivo. In this connection texture analysis of quantitative MR images may be of special importance. Because evaluation of texture analysis needs large data material, multicenter approaches become mandatory. Within the frame of BME Concerted Action on Tissue Characterization by MRI and MRS, a pilot multicenter study was launched in order to evaluate the technical problems including comparability of relaxation time measurements carried out in the individual sites. Human brain, skeletal muscle, and liver were used as models. A total of 218 healthy volunteers were studied. Fifteen MRI scanners with field strength ranging from 0.08 T to 1.5 T were induced. Measurement accuracy was tested on the Eurospin relaxation time test object (TO5) and the obtained calibration curve was used for correction of the in vivo data. The results established that, by following a standardized procedure, comparable quantitative measurements can be obtained in vivo from a number of MR sites. The overall variation coefficient in vivo was in the same order of magnitude as ex vivo relaxometry. Thus, it is possible to carry out international multicenter studies on quantitative imaging, provided that quality control with respect to measurement accuracy and calibration of the MR equipments are performed.

The Natural History of the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Studies: Design and Baseline Characteristics: ProgStar Report No. 1.

PubMed

Strauss, Rupert W; Ho, Alex; Muñoz, Beatriz; Cideciyan, Artur V; Sahel, José-Alain; Sunness, Janet S; Birch, David G; Bernstein, Paul S; Michaelides, Michel; Traboulsi, Elias I; Zrenner, Eberhart; Sadda, SriniVas; Ervin, Ann-Margret; West, Sheila; Scholl, Hendrik P N

2016-04-01

To describe the design and baseline characteristics of patients enrolled into 2 natural history studies of Stargardt disease (STGD1). Multicenter retrospective and prospective cohort studies. Three hundred sixty-five unique patients aged 6 years and older at baseline harboring disease-causing variants in the ABCA4 gene and with specified ocular lesions were enrolled from 9 centers in the United States and Europe. In the retrospective study, patients contributed medical record data from at least 2 and up to 4 visits for at least 1 examination modality: fundus autofluorescence (FAF), spectral-domain (SD) optical coherence tomography (SD OCT), and/or microperimetry (MP). The total observational period was at least 2 years and up to 5 years between single visits. Demographic and visual acuity (VA) data also were obtained. In the prospective study, eligible patients were examined at baseline using a standard protocol, with 6-month follow-up visits planned for a 2-year period for serial Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected VA, SD OCT, FAF, and MP. Design and rationale of a multicenter study to determine the progression of STGD1 in 2 large retrospective and prospective international cohorts. Detailed baseline characteristics of both cohorts are presented, including demographics, and structural and functional retinal metrics. Into the retrospective study, 251 patients (458 eyes) were enrolled; mean follow-up ± standard deviation was 3.9±1.6 years. At baseline, 36% had no or mild VA loss, and 47% of the study eyes had areas of definitely decreased autofluorescence (DDAF) with an average lesion area of 2.5±2.9 mm(2) (range, 0.02-16.03 mm(2)). Two hundred fifty-nine patients (489 eyes) were enrolled in the prospective study. At baseline, 20% had no or mild VA loss, and 64% had areas of DDAF with an average lesion area of 4.0±4.4 mm(2) (range, 0.03-24.24 mm(2)). The mean retinal sensitivity with MP was 10.8±5.0 dB. The ProgStar cohorts have baseline characteristics that encompass a wide range of disease severity and are expected to provide valuable data on progression based on serial quantitative measurements derived from multiple methods, which will be critical to the design of planned clinical trials. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Candidacy for bilateral hearing aids: a retrospective multicenter study.

PubMed

Boymans, Monique; Goverts, S Theo; Kramer, Sophia E; Festen, Joost M; Dreschler, Wouter A

2009-02-01

The goal of this study was to find factors for refining candidacy criteria for bilateral hearing aid fittings. Clinical files of 1,000 consecutive hearing aid fittings were analyzed. Case history, audiometric, and rehabilitation data were collected from clinical files, and an extensive questionnaire on long-term outcome measures was conducted. After at least 2 years of hearing aid use, 505 questionnaires were returned. In order to compare differences in benefits between unilateral and bilateral fittings, two subgroups were composed in which most relevant variables (age, degree of hearing loss, and audiometric asymmetry) were matched for unilateral fittings (n=212) and bilateral fittings (n=477). The bilateral group had significantly higher benefit scores than the unilateral group for detection, speech intelligibility in reverberation, and localization, but poorer scores for comfort of loud sounds. The benefit of bilateral hearing aids was not significantly related to the level of technology of the hearing aids. The analysis of the relation between objective parameters and the subjective outcome measures showed that candidacy for a successful bilateral fitting could not be predicted from age, maximum speech intelligibility, employment, exposure to background noise, or social activities.

Familial hypercholesterolemia: The Italian Atherosclerosis Society Network (LIPIGEN).

PubMed

Averna, Maurizio; Cefalù, Angelo B; Casula, Manuela; Noto, Davide; Arca, Marcello; Bertolini, Stefano; Calandra, Sebastiano; Catapano, Alberico L; Tarugi, Patrizia

2017-10-01

Primary dyslipidemias are a heterogeneous group of disorders characterized by abnormal levels of circulating lipoproteins. Among them, familial hypercholesterolemia is the most common lipid disorder that predisposes for premature cardiovascular disease. We set up an Italian nationwide network aimed at facilitating the clinical and genetic diagnosis of genetic dyslipidemias named LIPIGEN (LIpid TransPort Disorders Italian GEnetic Network). Observational, multicenter, retrospective and prospective study involving about 40 Italian clinical centers. Genetic testing of the appropriate candidate genes at one of six molecular diagnostic laboratories serving as nationwide DNA diagnostic centers. From 2012 to October 2016, available biochemical and clinical information of 3480 subjects with familial hypercholesterolemia identified according to the Dutch Lipid Clinic Network (DLCN) score were included in the database and genetic analysis was performed in 97.8% of subjects, with a mutation detection rate of 92.0% in patients with DLCN score ≥6. The establishment of the LIPIGEN network will have important effects on clinical management and it will improve the overall identification and treatment of primary dyslipidemias in Italy. Copyright © 2017. Published by Elsevier B.V.

Occult invasive cervical cancer after simple hysterectomy: a multi-center retrospective study of 89 cases.

PubMed

Bai, Huimin; Cao, Dongyan; Yuan, Fang; Wang, Huilan; Chen, Jie; Wang, Yue; Shen, Keng; Zhang, Zhenyu

2016-07-20

Occult invasive cervical cancer (OICC) is sometimes incidentally found in surgical specimens after a simple hysterectomy (SH). This study was aimed at identifying a subset of patients with OICC who have a favorable prognosis. This patient group may not require adjuvant radiotherapy and other procedures. The medical records of women in whom OICC was detected after an inadvertent SH were retrospectively reviewed. The relevant data, including clinicopathological characteristics, treatment and clinical outcome were evaluated. The primary and secondary endpoints were overall survival (OS) and relapse-free survival (RFS), respectively. Eighty-nine patients who met the inclusion criteria were included for analysis, and the risk of OICC was found to be 1.9 %. Finding an invasive cancer in a hysterectomy specimen after a conization procedure that shows positive margins was the most common reason (41.6 %) for the performance of inadvertent SH. In the univariate analysis, a tumor width > 20 mm, deep stromal invasion, and lymph node metastasis (LNM) were adversely associated with relapse (P < 0.001, < 0.001, and = 0.001, respectively) and survival (P = 0.003, 0.004, and 0.027, respectively), although these parameters were not independently associated with patient prognoses in the multivariate analysis. In patients with a tumor width ≤ 20 mm and superficial stromal invasion in the observation subgroup, the 5-year RFS and 5-year OS were both 100 %, whereas they were 57.1 % and 66.7 %, respectively, in patients with a tumor size > 20 mm and deep stromal invasion in the radiotherapy or chemotherapy subgroup (P < 0.001, and = 0.008, respectively). Simple observation after a lymphadenectomy procedure may be feasible in OICC patients with a tumor width ≤ 20 mm, superficial stromal invasion, a negative section margin in hysterectomy specimens, and no LNM.

Performance of endoscopic ultrasound in staging rectal adenocarcinoma appropriate for primary surgical resection.

PubMed

Ahuja, Nitin K; Sauer, Bryan G; Wang, Andrew Y; White, Grace E; Zabolotsky, Andrew; Koons, Ann; Leung, Wesley; Sarkaria, Savreet; Kahaleh, Michel; Waxman, Irving; Siddiqui, Ali A; Shami, Vanessa M

2015-02-01

Endoscopic ultrasound (EUS) often is used to stage rectal cancer and thereby guide treatment. Prior assessments of its accuracy have been limited by small sets of data collected from tumors of varying stages. We aimed to characterize the diagnostic performance of EUS analysis of rectal cancer, paying particular attention to determining whether patients should undergo primary surgical resection. We performed a retrospective observational study using procedural databases and electronic medical records from 4 academic tertiary-care hospitals, collecting data on EUS analyses from 2000 through 2012. Data were analyzed from 86 patients with rectal cancer initially staged as T2N0 by EUS. The negative predictive value (NPV) was calculated by comparing initial stages determined by EUS with those determined by pathology analysis of surgical samples. Logistic regression models were used to assess variation in diagnostic performance with case attributes. EUS excluded advanced tumor depth with an NPV of 0.837 (95% confidence interval [CI], 0.742-0.908), nodal metastasis with an NPV of 0.872 (95% CI, 0.783-0.934), and both together with an NPV of 0.767 (95% CI, 0.664-0.852) compared with pathology analysis. Incorrect staging by EUS affected treatment decision making for 20 of 86 patients (23.3%). Patient age at time of the procedure correlated with the NPV for metastasis to lymph node, but no other patient features were associated significantly with diagnostic performance. Based on a multicenter retrospective study, EUS staging of rectal cancer as T2N0 excludes advanced tumor depth and nodal metastasis, respectively, with an approximate NPV of 85%, similar to that of other modalities. EUS has an error rate of approximately 23% in identifying disease appropriate for surgical resection, which is lower than previously reported. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Impact of the Cancer Prevention and Control Research Network

PubMed Central

Ribisl, Kurt M.; Fernandez, Maria E.; Friedman, Daniela B.; Hannon, Peggy; Leeman, Jennifer; Moore, Alexis; Olson, Lindsay; Ory, Marcia; Risendal, Betsy; Sheble, Laura; Taylor, Vicky; Williams, Rebecca; Weiner, Bryan J.

2018-01-01

The Cancer Prevention and Control Research Network (CPCRN) is a thematic network dedicated to accelerating the adoption of evidence-based cancer prevention and control practices in communities by advancing dissemination and implementation science. Funded by the Centers for Disease Control and Prevention and National Cancer Institute, CPCRN has operated at two levels: Each participating Network Center conducts research projects with primarily local partners as well as multicenter collaborative research projects with state and national partners. Through multicenter collaboration, thematic networks leverage the expertise, resources, and partnerships of participating centers to conduct research projects collectively that might not be feasible individually. Although multicenter collaboration often is advocated, it is challenging to promote and assess. Using bibliometric network analysis and other graphical methods, this paper describes CPCRN’s multicenter publication progression from 2004 to 2014. Searching PubMed, Scopus, and Web of Science in 2014 identified 249 peer-reviewed CPCRN publications involving two or more centers out of 6,534 total. The research and public health impact of these multicenter collaborative projects initiated by CPCRN during that 10-year period were then examined. CPCRN established numerous workgroups around topics such as: 2-1-1, training and technical assistance, colorectal cancer control, federally qualified health centers, cancer survivorship, and human papillomavirus. The paper discusses the challenges that arise in promoting multicenter collaboration and the strategies that CPCRN uses to address those challenges. The lessons learned should broadly interest those seeking to promote multisite collaboration to address public health problems, such as cancer prevention and control. PMID:28215371

Live birth sex ratio after in vitro fertilization and embryo transfer in China--an analysis of 121,247 babies from 18 centers.

PubMed

Bu, Zhiqin; Chen, Zi-Jiang; Huang, Guoning; Zhang, Hanwang; Wu, Qiongfang; Ma, Yanping; Shi, Juanzi; Xu, Yanwen; Zhang, Songying; Zhang, Cuilian; Zhao, Xiaoming; Zhang, Bo; Huang, Yuanhua; Sun, Zhengyi; Kang, Yuefan; Wu, Riran; Wu, Xueqing; Sun, Haixiang; Sun, Yingpu

2014-01-01

In order to study the impact of procedures of IVF/ICSI technology on sex ratio in China, we conducted this multi-center retrospective study including 121,247 babies born to 93,895 women in China. There were 62,700 male babies and 58,477 female babies, making the sex ratio being 51.8% (Male: Female  = 107:100). In univariate logistic regression analysis, sex ratio was imbalance toward females of 50.3% when ICSI was preformed compared to 47.7% when IVF was used (P<0.01). The sex ratio in IVF/ICSI babies was significantly higher toward males in transfers of blastocyst (54.9%) and thawed embryo (52.4%) when compared with transfers of cleavage stage embryo (51.4%) and fresh embryo (51.5%), respectively. Multiple delivery was not associated with sex ratio. However, in multivariable logistic regression analysis after controlling for related factors, only ICSI (adjusted OR =  .90, 95%CI: 0.88-0.93; P<0.01) and blastocyst transfer (adjusted OR = 1.14, 95% CI: 1.09-1.20; P<0.01) were associated with sex ratio in IVF/ICSI babies. In conclusion, the live birth sex ratio in IVF/ICSI babies was influenced by the use of ICSI, which may decrease the percentage of male offspring, or the use of blastocyst transfer, which may increase the percentage of male offspring.

Risk Factors for Failure of Male Slings and Artificial Urinary Sphincters: Results from a Large Middle European Cohort Study.

PubMed

Hüsch, Tanja; Kretschmer, Alexander; Thomsen, Frauke; Kronlachner, Dominik; Kurosch, Martin; Obaje, Alice; Anding, Ralf; Pottek, Tobias; Rose, Achim; Olianas, Roberto; Friedl, Alexander; Hübner, Wilhelm; Homberg, Roland; Pfitzenmaier, Jesco; Grein, Ulrich; Queissert, Fabian; Naumann, Carsten Maik; Schweiger, Josef; Wotzka, Carola; Nyarangi-Dix, Joanne; Hofmann, Torben; Ulm, Kurt; Bauer, Ricarda M; Haferkamp, Axel

2017-01-01

We analysed the impact of predefined risk factors: age, diabetes, history of pelvic irradiation, prior surgery for stress urinary incontinence (SUI), prior urethral stricture, additional procedure during SUI surgery, duration of incontinence, ASA-classification and cause for incontinence on failure and complications in male SUI surgery. We retrospectively identified 506 patients with an artificial urinary sphincter (AUS) and 513 patients with a male sling (MS) in a multicenter cohort study. Complication rates were correlated to the risk factors in univariate analysis. Subsequently, a multivariate logistic regression adjusted to the risk factors was performed. A p value <0.05 was considered statistically significant. A history of pelvic irradiation was an independent risk factor for explantation in AUS (p < 0.001) and MS (p = 0.018). Moreover, prior urethral stricture (p = 0.036) and higher ASA-classification (p = 0.039) were positively correlated with explantation in univariate analysis for AUS. Urethral erosion was correlated with prior urethral stricture (p < 0.001) and a history of pelvic irradiation (p < 0.001) in AUS. Furthermore, infection was correlated with additional procedures during SUI surgery in univariate analysis (p = 0.037) in MS. We first identified the correlation of higher ASA-classification and explantation in AUS. Nevertheless, only a few novel risk factors had a significant influence on the failure of MS or AUS. © 2016 S. Karger AG, Basel.

Heart rupture predictors in Spanish myocardial infarction patients: evaluation using propensity score analysis.

PubMed

Ruiz-Bailén, Manuel; Expósito-Ruiz, Manuela; Castillo-Rivera, Ana-María; Rucabado-Aguilar, Luis; Ruiz-García, María Isabel; Ramos-Cuadra, José-Angel; Ruiz-Valverde, Andrés; Gómez-Jiménez, Javier; Benitez-Parejo, José-Luis; Cuñat de la Hoz, José; Abat, Francisco Felices; Valenzuela, Jesús Pérez

2010-05-01

The aim was to evaluate factors associated with the development of heart rupture in a Spanish registry of acute myocardial infarction (AMI) patients. This was a retrospective study of cohorts, including all patients diagnosed with AMI included in the ARIAM Spanish multicenter registry. The study period was from June 1996 to December 2005. The follow-up period was limited to the time of stay in intensive care or coronary care units. Multivariate logistic regression was used to study the factors associated with the development of heart rupture. A propensity score analysis was also performed to determine the involvement of beta blockers, ACE inhibitors, and fibrinolytics in the development of heart rupture. 16,815 AMI patients were included. Heart rupture occurred in 477 (2.8%). Heart rupture was associated with female gender, older age, the absence of previous infarct, and the administration of thrombolysis, while ACE inhibitors and beta blockers acted as protective variables. The propensity score analysis showed that fibrinolysis was a variable associated with heart rupture except in the younger subgroup and in the subgroup with less delay in administration. It was also found that beta blockers and ACE inhibitors are variables providing protection against heart rupture. Heart rupture is associated with older age, female gender, absence of previous infarct, and the administration of thrombolysis, while ACE inhibitors and beta blockers seem to prevent this complication.

Two-year Clinical Outcomes Post Implantation of Epic™ Self-Expanding Nitinol Stents for the Aortoiliac Occlusive Disease in Patients with Peripheral Arterial Disease

PubMed Central

Tsujimura, Takuya; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Ishihara, Takayuki; Nanto, Kiyonori; Kanda, Takashi; Okuno, Shota; Matsuda, Yasuhiro; Fujihara, Masahiko; Yokoi, Yoshiaki; Mano, Toshiaki

2018-01-01

Aim: We investigated 2-year clinical outcomes after implantaton of Epic™ self-expanding nitinol stents for patients with peripheral artery disease (PAD) due to the aortoiliac occlusive disease (AIOD). Methods: This study was a multicenter and retrospective study. From February 2013 through October 2014, 292 lesions (chronic total occlusion, 21%; TASC II C/D, 35%) in 217 consecutive patients (74 ± 8 years; male, 81%; diabetes mellitus, 47%; dialysis, 21%; critical limb ischemia, 29%) who had undergone endovascular therapy (EVT) with Epic™ self-expanding nitinol stents for PAD with AIOD were analyzed. The primary endpoints were 2-year primary patency and target lesion revascularization (TLR)-free rate. The primary patency and freedom from TLR were determined by Kaplan–Meier analysis. Additionally, predictors for loss of patency were estimated by Cox proportional hazard model. Results: The mean follow-up duration was 19.1 ± 8.5 months. Primary patency was 87.3% at 2 years. Freedom from TLR rate was 94.1% at 2 years. Multivariate analysis revealed that the presence of diabetes mellitus was associated with a loss of patency. Conclusion: The Epic™ self-expanding nitinol stent was demonstrated to be safe and effectivene for AIOD when tested for two years in patients with PAD. PMID:28978866

Two-year Clinical Outcomes Post Implantation of EpicTM Self-Expanding Nitinol Stents for the Aortoiliac Occlusive Disease in Patients with Peripheral Arterial Disease.

PubMed

Tsujimura, Takuya; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Ishihara, Takayuki; Nanto, Kiyonori; Kanda, Takashi; Okuno, Shota; Matsuda, Yasuhiro; Fujihara, Masahiko; Yokoi, Yoshiaki; Mano, Toshiaki

2018-04-01

We investigated 2-year clinical outcomes after implantaton of Epic TM self-expanding nitinol stents for patients with peripheral artery disease (PAD) due to the aortoiliac occlusive disease (AIOD). This study was a multicenter and retrospective study. From February 2013 through October 2014, 292 lesions (chronic total occlusion, 21%; TASC Ⅱ C/D, 35%) in 217 consecutive patients (74±8 years; male, 81%; diabetes mellitus, 47%; dialysis, 21%; critical limb ischemia, 29%) who had undergone endovascular therapy (EVT) with Epic TM self-expanding nitinol stents for PAD with AIOD were analyzed. The primary endpoints were 2-year primary patency and target lesion revascularization (TLR)-free rate. The primary patency and freedom from TLR were determined by Kaplan-Meier analysis. Additionally, predictors for loss of patency were estimated by Cox proportional hazard model. The mean follow-up duration was 19.1±8.5 months. Primary patency was 87.3% at 2 years. Freedom from TLR rate was 94.1% at 2 years. Multivariate analysis revealed that the presence of diabetes mellitus was associated with a loss of patency. The Epic TM self-expanding nitinol stent was demonstrated to be safe and effectivene for AIOD when tested for two years in patients with PAD.

Validation of the revised International Prognostic Scoring System in patients with myelodysplastic syndrome in Japan: results from a prospective multicenter registry.

PubMed

Kawabata, Hiroshi; Tohyama, Kaoru; Matsuda, Akira; Araseki, Kayano; Hata, Tomoko; Suzuki, Takahiro; Kayano, Hidekazu; Shimbo, Kei; Zaike, Yuji; Usuki, Kensuke; Chiba, Shigeru; Ishikawa, Takayuki; Arima, Nobuyoshi; Nogawa, Masaharu; Ohta, Akiko; Miyazaki, Yasushi; Mitani, Kinuko; Ozawa, Keiya; Arai, Shunya; Kurokawa, Mineo; Takaori-Kondo, Akifumi

2017-09-01

The Japanese National Research Group on Idiopathic Bone Marrow Failure Syndromes has been conducting prospective registration, central review, and follow-up study for patients with aplastic anemia and myelodysplastic syndrome (MDS) since 2006. Using this database, we retrospectively analyzed the prognosis of patients with MDS. As of May 2016, 351 cases were registered in this database, 186 of which were eligible for the present study. Kaplan-Meier analysis showed that overall survival (OS) curves of the five risk categories stipulated by the revised international prognostic scoring system (IPSS-R) were reasonably separated. 2-year OS rates for the very low-, low-, intermediate-, high-, and very high-risk categories were 95, 89, 79, 35, and 12%, respectively. In the same categories, incidence of leukemic transformation at 2 years was 0, 10, 8, 56, and 40%, respectively. Multivariate analysis revealed that male sex, low platelet counts, increased blast percentage (>2%), and high-risk karyotype abnormalities were independent risk factors for poor OS. Based on these data, we classified Japanese MDS patients who were classified as intermediate-risk in IPSS-R, into the lower risk MDS category, highlighting the need for careful assessment of treatments within low- and high-risk treatment protocols.

Leukocytosis is a risk factor for recurrent arterial thrombosis in young patients with polycythemia vera and essential thrombocythemia.

PubMed

De Stefano, Valerio; Za, Tommaso; Rossi, Elena; Vannucchi, Alessandro M; Ruggeri, Marco; Elli, Elena; Micò, Caterina; Tieghi, Alessia; Cacciola, Rossella R; Santoro, Cristina; Gerli, Giancarla; Guglielmelli, Paola; Pieri, Lisa; Scognamiglio, Francesca; Rodeghiero, Francesco; Pogliani, Enrico M; Finazzi, Guido; Gugliotta, Luigi; Leone, Giuseppe; Barbui, Tiziano

2010-02-01

There is evidence that leukocytosis is associated with an increased risk of first thrombosis in patients with polycythemia vera (PV) and essential thrombocythemia (ET). Whether it is a risk factor for recurrent thrombosis too is currently unknown. In the frame of a multicenter retrospective cohort study, we recruited 253 patients with PV (n = 133) or ET (n = 120), who were selected on the basis of a first arterial (70%) or venous major thrombosis (27.6%) or both (2.4%), and who were not receiving cytoreduction at the time of thrombosis. The probability of recurrent thrombosis associated with the leukocyte count recorded at the time of the first thrombosis was estimated by a receiver operating characteristic analysis and a multivariable Cox proportional hazards regression model. Thrombosis recurred in 78 patients (30.7%); multivariable analysis showed an independent risk of arterial recurrence (hazard ratio [HR] 2.16, 95% CI 1.12-4.18) in patients with a leukocyte count that was >12.4 x 10(9)/L at the time of the first thrombotic episode. The prognostic role for leukocytosis was age-related, as it was only significant in patients that were aged <60 years (HR for arterial recurrence 3.35, 95% CI 1.22-9.19).

Aortic valve sclerosis as a marker of coronary artery atherosclerosis; a multicenter study of a large population with a low prevalence of coronary artery disease.

PubMed

Rossi, Andrea; Gaibazzi, Nicola; Dandale, Raje; Agricola, Eustachio; Moreo, Antonella; Berlinghieri, Nicola; Sartorio, Daniele; Loffi, Marco; De Chiara, Benedetta; Rigo, Fausto; Vassanelli, Corrado; Faggiano, Pompilio

2014-03-15

There are no studies analyzing the association between aortic valve sclerosis (AVS) and coronary artery disease (CAD) in a large and multicenter patient population with an overall low prevalence of CAD. We hypothesized that AVS could predict the presence and degree of CAD in patients with severe organic mitral regurgitation. We retrospectively analyzed consecutive patients with flail mitral leaflet who had coronary angiography for pre-surgical screening and not because suspect of CAD. End-points were considered: 1) any degree of CAD (stenosis>20%) and 2) obstructive CAD (stenosis>75% of at least one coronary artery). AVS was defined as focal areas of increased echogenicity and thickening of the leaflets. Traditional clinical risk factors were considered: age, male gender, hypertension (>140/90 mmHg or medical therapy), hypercholesterolemia (total cholesterol>200 mg/dl or statin), diabetes, family history of CAD and smoking habit. 675 patients (mean age: 64±12; 27% female) formed the study population. Among patients with AVS, 60% and 39% had any-CAD and ob-CAD respectively, on the opposite among patients without AVS 12% and 7% had any-CAD and ob-cad. After adjustment for clinical risk factors, AVS was associated with a 22.7 fold increased risk of any degree of CAD (95% CI 8.1 63.6 p<0.0001) and with a 21.8 fold increased risk of obstructive-CAD (95% CI 6.6 71.9; p<0.0001). In a large and multicenter sample of patient with flail mitral leaflet, AVS was strongly associated with the presence and degree of CAD independently of clinical risk factors. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

PubMed

Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

2006-05-01

To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

Congenital H-type tracheoesophageal fistula: A multicenter review of outcomes in a rare disease.

PubMed

Fallon, Sara C; Langer, Jacob C; St Peter, Shawn D; Tsao, KuoJen; Kellagher, Caroline M; Lal, Dave R; Whitehouse, Jill S; Diesen, Diana L; Rollins, Michael D; Pontarelli, Elizabeth; Malek, Marcus M; Iqbal, Corey W; Upperman, Jeffrey S; Leys, Charles M; Wulkan, Mark L; Hill, Sarah J; Blakely, Martin L; Kane, Timothy D; Wesson, David E

2017-11-01

To perform a multicenter review of outcomes in patients with H-type tracheoesophageal fistula (TEF) in order to better understand the incidence and causes of post-operative complications. H-type TEF without esophageal atresia (EA) is a rare anomaly with a fundamentally different management algorithm than the more common types of EA/TEF. Outcomes after surgical treatment of H-type TEF are largely unknown, but many authoritative textbooks describe a high incidence of respiratory complications. A multicenter retrospective review of all H-type TEF patients treated at 14 tertiary children's hospital from 2002-2012 was performed. Data were systematically collected concerning associated anomalies, operative techniques, hospital course, and short and long-term outcomes. Descriptive analyses were performed. We identified 102 patients (median 9.5 per center, range 1-16) with H-type TEF. The overall survival was 97%. Most patients were repaired via the cervical approach (96%). The in-hospital complication rate, excluding vocal cord issues, was 16%; this included an 8% post-operative leak rate. Twenty-two percent failed initial extubation after repair. A total of 22% of the entire group had vocal cord abnormalities (paralysis or paresis) on laryngoscopy that were likely because of recurrent laryngeal nerve injury. Nine percent required a tracheostomy. Only 3% had a recurrent fistula, all of which were treated with reoperation. There is a high rate of recurrent laryngeal nerve injury after H-type TEF repair. This underscores the need for meticulous surgical technique at the initial repair and suggests that early vocal cord evaluation should be performed for any post-operative respiratory difficulty. Routine evaluation of vocal cord function after H-type TEF repair should be considered. Level IV. Copyright © 2017 Elsevier Inc. All rights reserved.

Outcome of proximal esophageal cancer after definitive combined chemo-radiation: a Swiss multicenter retrospective study.

PubMed

Herrmann, Evelyn; Mertineit, Nando; De Bari, Berardino; Hoeng, Laura; Caparotti, Francesca; Leiser, Dominic; Jumeau, Raphael; Cihoric, Nikola; Jensen, Alexandra D; Aebersold, Daniel M; Ozsahin, Mahmut

2017-06-14

To report oncological outcomes and toxicity rates, of definitive platin-based chemoradiadiationtherapy (CRT) in the management of proximal esophageal cancer. We retrospectively reviewed the medical records of patients with cT1-4 cN0-3 cM0 cervical esophageal cancer (CEC) (defined as tumors located below the inferior border of the cricoid cartilage, down to 22 cm from the incisors) treated between 2004 and 2013 with platin-based definitive CRT in four Swiss institutions. Acute and chronic toxicities were retrospectively scored using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE-NCI v.4.0). Primary endpoint was loco-regional control (LRC). We also evaluated overall survival (OS) and disease-free survival (DFS) rates. The influence of patient- and treatment related features have been calculated using the Log-rank test and multivariate Cox proportional hazards model. We enrolled a total of 55 patients. Median time interval from diagnosis to CRT was 78 days (6-178 days). Median radiation dose was 56Gy (28-72Gy). Induction chemotherapy (ICHT) was delivered in 58% of patients. With a median follow up of 34 months (6-110months), actuarial 3-year LRC, DFS and OS were 52% (95% CI: 37-67%), 35% (95% CI: 22-50%) and 52% (95% CI: 37-67%), respectively. Acute toxicities (dysphagia, pain, skin-toxicity) ranged from grade 0 - 4 without significant dose-dependent differences. On univariable analyses, the only significant prognostic factor for LRC was the time interval > 78 days from diagnosis to CRT. On multivariable analysis, total radiation dose >56Gy (p <0.006) and ICHT (p < 0.004) were statistically significant positive predictive factors influencing DFS and OS. Definitive CRT is a reliable therapeutic option for proximal esophageal cancer, with acceptable treatment related toxicities. Higher doses and ICHT may improve OS and DFS and. These findings need to be confirmed in further prospective studies.

Predictors of Relapse after Discontinuing Systemic Treatment in Childhood Autoimmune Chronic Uveitis.

PubMed

Simonini, Gabriele; Bracaglia, Claudia; Cattalini, Marco; Taddio, Andrea; Brambilla, Alice; De Libero, Cinzia; Pires Marafon, Denise; Caputo, Roberto; Cimaz, Rolando

2017-06-01

To identify clinical predictors of relapse in childhood autoimmune chronic uveitis after stopping systemic treatment. A retrospective, multicenter, cohort study. Ninety-four children in remission, receiving no treatments and with at least a 6-month followup, were enrolled. A higher probability of maintaining remission after discontinuing treatment was shown in idiopathic compared with juvenile idiopathic arthritis uveitis (Mantel-Cox chi-square = 23.21) if inactivity had been obtained within 6 months from starting systemic treatment (Mantel-Cox chi-square = 24.17) and by antitumor necrosis factor-α treatment (Mantel-Cox chi-square = 6.43). Type of disease, time, and type of systemic therapy to achieve inactivity predict different duration of uveitis remission after treatment withdrawal.

Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with post-menopausal estrogen receptor-positive advanced breast cancer: a sub-group analysis of the JBCRG-C06 Safari study.

PubMed

Kawaguchi, Hidetoshi; Masuda, Norikazu; Nakayama, Takahiro; Aogi, Kenjiro; Anan, Keisei; Ito, Yoshinori; Ohtani, Shoichiro; Sato, Nobuaki; Saji, Shigehira; Takano, Toshimi; Tokunaga, Eriko; Nakamura, Seigo; Hasegawa, Yoshie; Hattori, Masaya; Fujisawa, Tomomi; Morita, Satoshi; Yamaguchi, Miki; Yamashita, Hiroko; Yamashita, Toshinari; Yamamoto, Yutaka; Yotsumoto, Daisuke; Toi, Masakazu; Ohno, Shinji

2018-01-01

The JBCRG-C06 Safari study showed that earlier fulvestrant 500 mg (F500) use, a longer time from diagnosis to F500 use, and no prior palliative chemotherapy were associated with significantly longer time to treatment failure (TTF) among Japanese patients with estrogen receptor-positive (ER+) advanced breast cancer (ABC). The objective of this sub-group analysis was to further examine data from the Safari study, focusing on ER + and human epidermal growth factor receptor-negative (HER2-) cases. The Safari study (UMIN000015168) was a retrospective, multi-center cohort study, conducted in 1,072 patients in Japan taking F500 for ER + ABC. The sub-analysis included only patients administered F500 as second-line or later therapy (n = 960). Of these, 828 patients were HER2-. Results Multivariate analysis showed that advanced age (≥65 years; p = .035), longer time (≥3 years) from ABC diagnosis to F500 use (p < .001), no prior chemotherapy (p < .001), and F500 treatment line (p < .001) were correlated with prolonged TTF (median = 5.39 months). In ER+/HER2- patients receiving F500 as a second-line or later therapy, treatment line, advanced age, no prior palliative chemotherapy use, and a longer period from ABC diagnosis to F500 use were associated with longer TTF.

Uso de recursos y costos de hospitalizaciones por insufi ciencia card í aca: un estudio retrospective multic é ntrico en Argentina.

PubMed

Augustovski, Federico; Caporale, Joaquín; Fosco, Matías; Alcaraz, Andrea; Diez, Mirta; Thierer, Jorge; Peradejordi, Margarita; Pichon Riviere, Andrés

2017-12-01

Heart failure has a great impact on health budget, mainly due to the cost of hospitalizations. Our aim was to describe health resource use and costs of heart failure admissions in three important institutions in Argentina. Multi-center retrospective cohort study, with descriptive and analytical analysis by subgroups of ejection fraction, blood pressure and renal function at admission. Generalized linear models were used to assess the association of independent variables to main outcomes. We included 301 subjects; age 75.3±11.8 years; 37% women; 57% with depressed ejection fraction; 46% of coronary etiology. Blood pressure at admission was 129.8±29.7 mmHg; renal function 57.9±26.2 ml/min/1.73 m 2 . Overall mortality was 7%. Average length of stay was 7.82±7.06 days (median 5.69), and was significantly longer in patients with renal impairment (8.9 vs. 8.18; p=0.03) and shorter in those with high initial blood pressure (6.08±4.03; p=0.009). Mean cost per patient was AR$68,861±96,066 (US$=8,071; 1US$=AR$8.532); 71% attributable to hospital stay, 20% to interventional procedures and 6.7% to diagnostic studies. Variables independently associated with higher costs were depressed ejection fraction, presence of valvular disease, and impaired renal function. Resource use and costs associated to hospitalizations for heart failure is high, and the highest proportion is attributable to the costs related to hospital stay. Copyright © 2017. Published by Elsevier Inc.

Using Rasch motor FIM individual growth curves to inform clinical decisions for persons with paraplegia.

PubMed

Pretz, C R; Kozlowski, A J; Charlifue, S; Chen, Y; Heinemann, A W

2014-09-01

A longitudinal retrospective study. To better understand individual-level temporal change in functional status for participants with paraplegia in the National Spinal Cord Injury Database (NSCID), as measured by Rasch Transformed Motor Functional Indepedence Measure (FIM) scores. Multicenter/Multistate longitudinal study across the United States. Non-linear random effects modeling, that is, individual growth curve analysis of retrospective data obtained from the National Institute on Disability and Rehabilitation Research (NIDRR) NSCID. We generated non-linear individual level trajectories of recovery for Rasch Transformed Motor FIM scores that rise rapidly from inpatient rehabilitation admission to a plateau. Trajectories are based on relationships between growth parameters and patient and injury factors: race, gender, level of education at admission, age at injury, neurological level at discharge, American Spinal Injury Association Impairment Scale (AIS) at discharge, days from injury to first system inpatient rehabilitation admission, rehabilitation length of stay, marital status and etiology. On the basis of study results, an interactive tool was developed to represent individual level longitudinal outcomes as trajectories based upon an individual's given baseline characteristics, that is, information supplied by the covariates and provides a robust description of temporal change for those with paraplegia within the NSCID. This methodology allows researchers and clinicians to generate and better understand patient-specific trajectories through the use of an automated interactive tool where a nearly countless number of longitudinal paths of recovery can be explored. Projected trajectories holds promise in facilitating planning for inpatient and outpatient services, which could positively impact long term outcomes.

Mortality and prognostic factors in idiopathic inflammatory myositis: a retrospective analysis of a large multicenter cohort of Spain.

PubMed

Nuño-Nuño, Laura; Joven, Beatriz Esther; Carreira, Patricia E; Maldonado-Romero, Valentina; Larena-Grijalba, Carmen; Cubas, Irene Llorente; Tomero, Eva Gloria; Barbadillo-Mateos, María Carmen; De la Peña Lefebvre, Paloma García; Ruiz-Gutiérrez, Lucía; López-Robledillo, Juan Carlos; Moruno-Cruz, Henry; Pérez, Ana; Cobo-Ibáñez, Tatiana; Almodóvar González, Raquel; Lojo, Leticia; García De Yébenes, María Jesús; López-Longo, Francisco Javier

2017-11-01

The present study was undertaken to assess mortality, causes of death, and associated prognostic factors in a large cohort of patients diagnosed with idiopathic inflammatory myositis (IIM) from Spain. A retrospective longitudinal study was carried out in 467 consecutive patients with IIM, identified from 12 medical centers. Patients were classified as primary polymyositis, primary dermatomyositis (DM), overlap myositis, cancer-associated myositis (CAM), and juvenile idiopathic inflammatory myopathies. A total of 113 deaths occurred (24%) after a median follow-up time of 9.7 years. In the overall cohort, the 2-, 5-, and 10-year survival probabilities were 91.9, 86.7, and 77%, respectively. Main causes of death were infections and cancer (24% each). Multivariate model revealed that CAM (HR = 24.06), OM (HR = 12.00), DM (HR = 7.26), higher age at diagnosis (HR = 1.02), severe infections (HR = 3.66), interstitial lung disease (HR = 1.61), and baseline elevation of acute phase reactants (HR = 3.03) were associated with a worse prognosis, while edema of the hands (HR = 0.39), female gender (HR = 0.39), and longer disease duration (HR = 0.73) were associated with a better prognosis. The standardized mortality ratio was 1.56 (95% CI 1.28-1.87) compared to the Spanish general population. Our findings indicate that IIM has a high long-term mortality, with an excess of mortality compared to the Spanish population. A more aggressive therapy may be required in IIM patients presenting with poor predictive factors.

Toward earlier detection of choroidal neovascularization secondary to age-related macular degeneration: multicenter evaluation of a preferential hyperacuity perimeter designed as a home device.

PubMed

Loewenstein, Anat; Ferencz, Joseph R; Lang, Yaron; Yeshurun, Itamar; Pollack, Ayala; Siegal, Ruth; Lifshitz, Tova; Karp, Joseph; Roth, Daniel; Bronner, Guri; Brown, Justin; Mansour, Sam; Friedman, Scott; Michels, Mark; Johnston, Richards; Rapp, Moshe; Havilio, Moshe; Rafaeli, Omer; Manor, Yair

2010-01-01

The primary purpose of this study was to evaluate the ability of a home device preferential hyperacuity perimeter to discriminate between patients with choroidal neovascularization (CNV) and intermediate age-related macular degeneration (AMD), and the secondary purpose was to investigate the dependence of sensitivity on lesion characteristics. All participants were tested with the home device in an unsupervised mode. The first part of this work was retrospective using tests performed by patients with intermediate AMD and newly diagnosed CNV. In the second part, the classifier was prospectively challenged with tests performed by patients with intermediate AMD and newly diagnosed CNV. The dependence of sensitivity on lesion characteristics was estimated with tests performed by patients with CNV of both parts. In 66 eyes with CNV and 65 eyes with intermediate AMD, both sensitivity and specificity were 0.85. In the retrospective part (34 CNV and 43 intermediate AMD), sensitivity and specificity were 0.85 +/- 0.12 (95% confidence interval) and 0.84 +/- 0.11 (95% confidence interval), respectively. In the prospective part (32 CNV and 22 intermediate AMD), sensitivity and specificity were 0.84 +/- 0.13 (95% confidence interval) and 0.86 +/- 0.14 (95% confidence interval), respectively. Chi-square analysis showed no dependence of sensitivity on type (P = 0.44), location (P = 0.243), or size (P = 0.73) of the CNV lesions. A home device preferential hyperacuity perimeter has good sensitivity and specificity in discriminating between patients with newly diagnosed CNV and intermediate AMD. Sensitivity is not dependent on lesion characteristics.

Control of seizures in different stages of partial epilepsy: LACO-EXP, a Spanish retrospective study of lacosamide.

PubMed

Villanueva, Vicente; López, Francisco Javier; Serratosa, José María; González-Giraldez, Beatriz; Campos, Dulce; Molins, Albert; Rodriguez Uranga, Juan; Mauri, José Angel; Salas-Puig, Javier; Toledo, Manuel; Sánchez-Alvarez, Juan Carlos; Moreno, Antonio; Serrano-Castro, Pedro J; Saiz-Diaz, Rosa Ana; González de la Aleja, Jesús; de la Peña, Pilar; Asensio, Montserrat

2013-11-01

Lacosamide is approved as adjunctive therapy for focal epilepsies. The number of antiepileptic drugs (AEDs) tried is associated with prognosis. This multicenter, retrospective, observational study (LACO-EXP) in Spain in 500 adult patients with focal epilepsies examined the efficacy and tolerability of add-on lacosamide. Factors associated with better efficacy/tolerability were analyzed. After 12months, the responder rate (≥50% reduction in seizure frequency) was 57.1%, and the seizure-free rate was 14.9%. Efficacy was better when lacosamide was the first or second add-on AED, although there was a small chance to be seizure-free even for patients who had received ≤10 prior AEDs. The mechanism of action of concomitant AEDs is important in all the stages, but differences are smaller in the early stages. Lacosamide was generally well tolerated. A slower dosage-titration schedule was associated with a lower adverse event rate. Further investigation of the timing of initiation of lacosamide add-on therapy and ideal combinations of AEDs is required. © 2013.

Prevalence and Outcomes in Patients Undergoing Reintubation After Anterior Cervical Spine Surgery: Results From the AOSpine North America Multicenter Study on 8887 Patients.

PubMed

Nagoshi, Narihito; Fehlings, Michael G; Nakashima, Hiroaki; Tetreault, Lindsay; Gum, Jeffrey L; Smith, Zachary A; Hsu, Wellington K; Tannoury, Chadi A; Tannoury, Tony; Traynelis, Vincent C; Arnold, Paul M; Mroz, Thomas E; Gokaslan, Ziya L; Bydon, Mohamad; De Giacomo, Anthony F; Jobse, Bruce C; Massicotte, Eric M; Riew, K Daniel

2017-04-01

A multicenter, retrospective cohort study. To evaluate clinical outcomes in patients with reintubation after anterior cervical spine surgery. A total of 8887 patients undergoing anterior cervical spine surgery were enrolled in the AOSpine North America Rare Complications of Cervical Spine Surgery study. Patients with or without complications after surgery were included. Demographic and surgical information were collected for patients with reintubation. Patients were evaluated using a variety of assessment tools, including the modified Japanese Orthopedic Association scale, Nurick score, Neck Disability Index, and Short Form-36 Health Survey. Nine cases of postoperative reintubation were identified. The total prevalence of this complication was 0.10% and ranged from 0% to 0.59% across participating institutions. The time to development of airway symptoms after surgery was within 24 hours in 6 patients and between 5 and 7 days in 3 patients. Although 8 patients recovered, 1 patient died. At final follow-up, patients with reintubation did not exhibit significant and meaningful improvements in pain, functional status, or quality of life. Although the prevalence of reintubation was very low, this complication was associated with adverse clinical outcomes. Clinicians should identify their high-risk patients and carefully observe them for up to 2 weeks after surgery.

Comparison of the clinical efficacy between single-agent and dual-agent concurrent chemoradiotherapy in the treatment of unresectable esophageal squamous cell carcinoma: a multicenter retrospective analysis.

PubMed

Li, Jie; Gong, Youling; Diao, Peng; Huang, Qingmei; Wen, Yixue; Lin, Binwei; Cai, Hongwei; Tian, Honggang; He, Bing; Ji, Lanlan; Guo, Ping; Miao, Jidong; Du, Xiaobo

2018-01-22

Some Chinese patients with esophageal squamous cell carcinomaare often treated with single-agent concurrent chemoradiotherapy. However, no results have been reported from randomized controlled clinical trials comparing single-agent with double-agent concurrent chemoradiotherapy. It therefore remains unclear whether these regimens are equally clinically effective. In this study, we retrospectively analyzed and compared the therapeutic effects of single-agent and double-agent concurrent chemoradiotherapy in patients with unresectable esophageal squamous cell carcinoma. This study enrolled 168 patients who received definitive concurrent chemoradiotherapy for locally advanced unresectable esophageal squamous carcinoma at 10 hospitals between 2010 and 2015. We evaluated survival time and toxicity. The Kaplan-Meier method was used to estimate survival data. The log-rank test was used in univariate analysis A Cox proportional hazards regression model was used to conduct a multivariate analysis of the effects of prognostic factors on survival. In this study, 100 (59.5%) and 68 patients (40.5%) received single-agent and dual-agent combination chemoradiotherapy, respectively. The estimate 5-year progression-free survival (PFS) rate and overall survival (OS) rate of dual-agent therapy was higher than that of single-agent therapy (52.5% and 40.9%, 78.2% and 60.7%, respectively), but there were no significant differences (P = 0.367 and 0.161, respectively). Multivariate analysis showed that sex, age,and radiotherapy dose had no significant effects on OS or PFS. Only disease stage was associated with OS and PFS in the multivariable analysis (P = 0.006 and 0.003, respectively). In dual-agent group, the incidence of acute toxicity and the incidence of 3 and4 grade toxicity were higher than single-agent group. The 5-year PFS and OS rates of dual-agent therapy were higher than those of single-agent concurrent chemoradiotherapy for patients with unresectable esophageal squamous cell carcinoma; however, there were no significant differences in univariate analysis and multivariable analysis. Single-agent concurrent chemotherapy had less toxicity than a double-drug regimen. Therefore, we suggest that single therapis not inferior to dual therapy y. In the future, we aim to confirm our hypothesis through a prospective randomized study.

Risk-related 18F-FDG PET/CT and new diagnostic strategies in patients with solitary pulmonary nodule: the ITALIAN multicenter trial.

PubMed

Spadafora, Marco; Pace, Leonardo; Evangelista, Laura; Mansi, Luigi; Del Prete, Francesco; Saladini, Giorgio; Miletto, Paolo; Fanti, Stefano; Del Vecchio, Silvana; Guerra, Luca; Pepe, Giovanna; Peluso, Giuseppina; Nicolai, Emanuele; Storto, Giovanni; Ferdeghini, Marco; Giordano, Alessandro; Farsad, Mohsen; Schillaci, Orazio; Gridelli, Cesare; Cuocolo, Alberto

2018-05-05

Diagnosis of solitary pulmonary nodule (SPN) is an important public health issue and 18 F-FDG PET/CT has proven to be more effective than CT alone. Pre-test risk stratification and clinical presentation of SPN could affect the diagnostic strategy. A relevant issue is whether thoracic segmental (s)-PET/CT could be implemented in patients with SPN. This retrospective multicenter study compared the results of FDG whole-body (wb)-PET/CT to those of s-PET/CT. 18 F-FDG PET/CT of 502 patients, stratified for pre-test cancer risk, were retrospectively analyzed. The thoracic part of wb-PET/CT, considered s-PET/CT, was compared to wb-PET/CT. Clinical and PET/CT variables were investigated for SPN characterization as well as for identification of patients in whom s-PET/CT could be performed. Histopathology or follow-up data were used as a reference. In the study population, 36% had malignant, 35% benign, and 29% indeterminate SPN. 18 F-FDG uptake indicative of thoracic and extra-thoracic lesions was detectable in 13% and 3% of the patients. All patients with extra-thoracic metastases (n = 13) had thoracic lymph node involvement and highest 18 F-FDG uptake at level of SPN (negative predictive value 100%). Compared to wb-PET/CT, s-PET/CT could save about 2/3 of 18 F-FDG dose, radiation exposure or scan-time, without affecting the clinical impact of PET/CT. Pre-test probability of malignancy can guide the diagnostic strategy of 18 FDG-PET/CT in patients with SPN. In subjects with low-intermediate pretest probability s-PET/CT imaging might be planned in advance, while in those at high risk and with thoracic lymph node involvement a wb-PET/CT is necessary.

Comparison of the Performance Between Sepsis-1 and Sepsis-3 in ICUs in China: A Retrospective Multicenter Study.

PubMed

Cheng, Baoli; Li, Zhongwang; Wang, Jingya; Xie, Guohao; Liu, Xu; Xu, Zhipeng; Chu, Lihua; Zhao, Jialian; Yao, Yongming; Fang, Xiangming

2017-09-01

The definition of sepsis was updated to sepsis-3 in February 2016. However, the performance of the previous and new definition of sepsis remains unclear in China. This was a retrospective multicenter study in six intensive care unit (ICUs) from five university-affiliated hospitals to compare the performance between sepsis-1 and sepsis-3 in China. From May 1, 2016 to June 1, 2016, 496 patients were enrolled consecutively. Data were extracted from the electronic clinical records. We evaluated the performance of sepsis-1 and sepsis-3 by measuring the area under the receiver operating characteristic curves (AUROC) to predict 28-day mortality rates. Of 496 enrolled patients, 186 (37.5%) were diagnosed with sepsis according to sepsis-1, while 175 (35.3%) fulfilled the criteria of sepsis-3. The AUROC of systemic inflammatory response syndrome (SIRS) is significantly smaller than that of sequential organ failure assessment (SOFA) (0.55 [95% confidence interval, 0.46-0.64] vs. 0.69 (95% confidence interval, 0.61-0.77], P = 0.008) to predict 28-day mortality rates of infected patients. Moreover, 5.9% infected patients (11 patients) were diagnosed as sepsis according to sepsis-1 but not to sepsis-3. The APACHE II, SOFA scores, and mortality rate of the 11 patients were significantly lower than of patients whose sepsis was defined by both the previous and new criteria (8.6±3.5 vs. 16.3±6.2, P =  < 0.001; 1 (0-1) vs. 6 (4-8), P = <0.001; 0.0 vs. 33.1%, P = 0.019). In addition, the APACHE II, length of stay in ICU, and 28-day mortality rate of septic patients rose gradually corresponding with the raise in SOFA score (but not the SIRS score). Sepsis-3 performed better than sepsis-1 in the study samples in ICUs in China.

Sequential Therapy with Crizotinib and Alectinib in ALK-Rearranged Non-Small Cell Lung Cancer-A Multicenter Retrospective Study.

PubMed

Ito, Kentaro; Hataji, Osamu; Kobayashi, Hiroyasu; Fujiwara, Atsushi; Yoshida, Masamichi; D'Alessandro-Gabazza, Corina N; Itani, Hidetoshi; Tanigawa, Motoaki; Ikeda, Takuya; Fujiwara, Kentaro; Fujimoto, Hajime; Kobayashi, Tetsu; Gabazza, Esteban C; Taguchi, Osamu; Yamamoto, Nobuyuki

2017-02-01

Alectinib and crizotinib have been approved for the therapy of NSCLC caused by anaplastic lymphoma kinase gene (ALK) rearrangement. The effect of alectinib or crizotinib on overall survival (OS) in patients with ALK-rearranged NSCLC remains unknown. A multicenter retrospective study was conducted to compare OS between patients receiving alectinib and crizotinib and between patients treated with alectinib and those treated sequentially with crizotinib and then alectinib after crizotinib failure. The time to treatment failure (TTF), progression-free survival (PFS), and OS were compared. Sixty-one patients with ALK-rearranged NSCLC were enrolled. Forty-six patients were treated with anaplastic lymphoma kinase (ALK) inhibitors (31 with crizotinib, 28 with alectinib, and 13 with both ALK inhibitors). The response rate was 66.7% for the crizotinib-treated group and 80.8% for the alectinib-treated group. Among all patients, TTF and PFS were significantly prolonged in the alectinib-treated group compared with in the crizotinib-treated group. Subgroup analyses revealed significantly prolonged TTF for alectinib compared with crizotinib therapy in the ALK inhibitor-naive population. OS was significantly longer in the alectinib-treated group than in the crizotinib-treated group. The TTF and OS of patients treated sequentially with crizotinib and then with alectinib after crizotinib failure tended to be longer than those of patients treated with alectinib alone. Therapy with alectinib alone was significantly superior to therapy with crizotinib alone in terms of TTF, PFS, and OS, and sequential therapy with crizotinib and alectinib after crizotinib failure tended to provide a better OS benefit than did therapy with alectinib alone in patients with ALK-positive NSCLC. However, large-scale prospective studies are needed to confirm these observations. Copyright © 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

Stereotactic Ablative Radiotherapy for stage I histologically proven non-small cell lung cancer: an Italian multicenter observational study.

PubMed

Ricardi, Umberto; Frezza, Giovanni; Filippi, Andrea Riccardo; Badellino, Serena; Levis, Mario; Navarria, Piera; Salvi, Fabrizio; Marcenaro, Michela; Trovò, Marco; Guarneri, Alessia; Corvò, Renzo; Scorsetti, Marta

2014-06-01

Aim of this retrospective multicenter observational study was to provide data on outcomes and prognostic factors in patients affected with stage I histologically confirmed NSCLC treated with Stereotactic Ablative Radiotherapy (SABR, or Stereotactic Body Radiotherapy, SBRT) outside clinical trials. We analyzed a cohort of 196 patients with histological/cytological diagnosis of NSCLC. Median age at treatment was 75 years old; median tumor diameter was 2.48 cm, and median GTV 13.3 cc. One hundred fifty-five patients had stage IA disease (79.1%) and 41 patients stage IB disease (20.9%). Total doses ranged from 48 to 60 Gy in 3-8 fractions. Primary endpoints of the study were safety (acute and late toxicity) and efficacy (Local Control, Disease-Free Survival, Overall and Cancer-Specific Survival). Median follow-up time was 30 months. The percentage of grade ≥2 pulmonary toxicity was 3%, and the 30 and 60 days mortality rate was 0%. Local Recurrence-Free Survival was 89.7% at 3 years. Fifty-nine patients (30.1%) had at least one failure (local and/or nodal and/or distant), with a Disease-Free Survival (DFS) rate at 3 years of 65.5%. Overall Survival (OS) and Cancer-Specific Survival (CSS) rates were 68% and 82.1% at 3 years, respectively. Median time to any recurrence was 15 months, while median overall survival time was 54 months. At multivariate analysis, stage IB was the only variable associated to a decrease in DFS, OS and CSS (HR 2.77, p = 0.006; HR 2.38, p = 0.009; HR 4.06, p ≤ 0.001, respectively). A difference in survival according to stage was also evident at the log-rank test (p ≤ 0.0001 for CSS and OS). The results of the present study support the routine use of SABR for stage I NSCLC in a daily practice environment. The only prognostic factor that has been confirmed by our analysis was tumor stage (IA vs. IB). Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Italian Percutaneous EVAR (IPER) Registry: outcomes of 2381 percutaneous femoral access sites' closure for aortic stent-graft.

PubMed

Pratesi, G; Barbante, M; Pulli, R; Fargion, A; Dorigo, W; Bisceglie, R; Ippoliti, A; Pratesi, C

2015-12-01

The aim of this paper was to report outcomes of endovascular aneurysm repair with percutaneous femoral access (pEVAR) using Prostar XL and Proglide closure systems (Abbot Vascular, Santa Clara, CA, USA), from the multicenter Italian Percutaneous EVAR (IPER) registry. Consecutive patients affected by aortic pathology treated by EVAR with percutaneous access (pEVAR) between January 2010 and December 2014 at seven Italian centers were enrolled in this multicenter registry. All the operators had an experience of at least 50 percutaneous femoral access procedures. Data were prospectively collected into a dedicated online database including patient's demographics, anatomical features, intra- and postoperative outcomes. A retrospective analysis was carried out to report intraoperative and 30-day technical success and access-related complication rate. Uni- and multivariate analyses were performed to identify factors potentially associated with an increased risk of percutaneous pEVAR failure. A total of 2381 accesses were collected in 1322 patients, 1249 (94.4%) male with a mean age of 73.5±8.3 years (range 45-97). The overall technical success rate was 96.8% (2305/2381). Major intraoperative access-related complications requiring conversion to surgical cut-down were observed in 3.2% of the cases (76/2381). One-month pEVAR failure-rate was 0.25% (6/2381). Presence of femoral artery calcifications resulted to be a significant predictor of technical failure (OR: 1.69; 95% CI: 1.03-2.77; P=0.036) at multivariate analysis. No significant association was observed with sex (P=0.28), obesity (P=0.64), CFA diameter (P=0.32), level of CFA bifurcation (P=0.94) and sheath size >18 F (P=0.24). The use of Proglide was associated with a lower failure rate compared to Prostar XL (2.5% vs. 3.3%) despite not statistically significant (P=0.33). The results of the IPER registry confirm the high technical success rate of percutaneous EVAR when performed by experienced operators, even in presence of demanding anatomies. Femoral calcification represents the only predictor of percutaneous access failure.

Place of upper endoscopy before and after bariatric surgery: A multicenter experience with 3219 patients

PubMed Central

Abd Ellatif, Mohamed E; Alfalah, Haitham; Asker, Walid A; El Nakeeb, Ayman E; Magdy, Alaa; Thabet, Waleed; Ghaith, Mohamed A; Abdallah, Emad; Shahin, Rania; Shoma, Asharf; Dawoud, Ibraheim E; Abbas, Ashraf; Salama, Asaad F; Ali Gamal, Maged

2016-01-01

AIM: To study the preoperative and postoperative role of upper esophagogastroduodenoscopy (EGD) in morbidly obese patients. METHODS: This is a multicenter retrospective study by reviewing the database of patients who underwent bariatric surgery (laparoscopic sleeve gastrectomy, laparoscopic Roux en Y gastric bypass, or laparoscopic minigastric bypass) in the period between 2001 June and 2015 August (Jahra Hospital-Kuwait, Hafr Elbatin Hospital and King Saud Medical City-KSA, and Mansoura University Hospital - Egypt). Patients with age 18-65 years, body mass index (BMI) > 40, or > 35 with comorbidities after failure of many dietetic regimen and acceptable levels of surgical risk were included in the study after having an informed signed consent. We retrospectively reviewed the medical charts of all morbidly obese patients. The patients’ preoperative data included clinical history including upper digestive symptoms and preoperative full workup including EGD. Only patients whose charts revealed weather they were symptomatic or not were studied. We categorized patients accordingly into two groups; with (group A) or without (group B) upper digestive symptoms. The endoscopic findings were categorized into 4 groups based on predetermined criteria. The medical record of patients who developed stricture, leak or bleeding after bariatric surgery was reviewed. Logestic regression analysis was used to identify preoperative predictors that might be associated with abnormal endoscopic findings. RESULTS: Three thousand, two hundred and nineteen patients in the study period underwent bariatric surgery (75% LSG, 10% LRYDB, and 15% MGB). Mean BMI was 43 ± 13, mean age 37 ± 9 years, 79% were female. Twenty eight percent had presented with upper digestive symptoms (group A). EGD was considered normal in 2414 (75%) patients (9% group A vs 66% group B, P = 0.001). The abnormal endoscopic findings were found high in those patients with upper digestive symptoms. Abnormal findings (one or more) were found in 805 (25%) patients (19% group A vs 6% group B, P = 0.001). Seven patients had critical events during conscious sedation due to severe hypoxemia (< 60%). Rate of stricture in our study was 2.6%. Success rate of endoscopic dilation was 100%. One point nine percent patients with gastric leak were identified with 75% success rate of endoscopic therapy. Three point seven percent patients developed acute upper bleeding. Seventy-eight point two percent patients were treated by conservative therapy and EGD was performed in 21.8% with 100% success and 0% complications. CONCLUSION: Our results support the performance of EGD only in patients with upper gastrointestinal symptoms. Endoscopy also offers safe effective tool for anastomotic complications after bariatric surgery. PMID:27247708

Addressing data privacy in matched studies via virtual pooling.

PubMed

Saha-Chaudhuri, P; Weinberg, C R

2017-09-07

Data confidentiality and shared use of research data are two desirable but sometimes conflicting goals in research with multi-center studies and distributed data. While ideal for straightforward analysis, confidentiality restrictions forbid creation of a single dataset that includes covariate information of all participants. Current approaches such as aggregate data sharing, distributed regression, meta-analysis and score-based methods can have important limitations. We propose a novel application of an existing epidemiologic tool, specimen pooling, to enable confidentiality-preserving analysis of data arising from a matched case-control, multi-center design. Instead of pooling specimens prior to assay, we apply the methodology to virtually pool (aggregate) covariates within nodes. Such virtual pooling retains most of the information used in an analysis with individual data and since individual participant data is not shared externally, within-node virtual pooling preserves data confidentiality. We show that aggregated covariate levels can be used in a conditional logistic regression model to estimate individual-level odds ratios of interest. The parameter estimates from the standard conditional logistic regression are compared to the estimates based on a conditional logistic regression model with aggregated data. The parameter estimates are shown to be similar to those without pooling and to have comparable standard errors and confidence interval coverage. Virtual data pooling can be used to maintain confidentiality of data from multi-center study and can be particularly useful in research with large-scale distributed data.

Retrospective evaluation of recurrent secondary septic peritonitis in dogs (2000-2011): 41 cases.

PubMed

Barfield, Dominic M; Tivers, Michael S; Holahan, Matthew; Welch, Kristin; House, Arthur; Adamantos, Sophie E

2016-01-01

To describe the clinical characteristics of recurrent septic peritonitis in dogs. Multicenter retrospective observational study. Client-owned dogs with recurrent septic peritonitis. Three university emergency and referral hospitals. None. Medical records from 3 veterinary university teaching hospitals were reviewed and data were collected using a standardized data collection sheet for all cases of septic peritonitis during the study period (2000-2011). Forty one dogs met the inclusion criteria for recurrent peritonitis. All dogs underwent relaparotomy. The original cause of septic peritonitis in these cases included previous surgery for gastrointestinal foreign body removal (n = 26), gastrointestinal neoplasia (n = 3), gastric or duodenal ulceration (n = 3), biliary tract leakage (n = 2), and single instance for each of the following: penetrating foreign body, hernia strangulation, intussusception, mesenteric volvulus, infection of the laparotomy incision, prostatic abscess, and trauma. Eighteen animals survived to discharge. There was no difference detected between survivors and nonsurvivors with recurrent peritonitis in terms of inciting cause, serum albumin concentration, surgical management, or provision of appropriate initial antimicrobials. The survival rate for dogs having recurrent peritonitis was 43.9% (18/41 dogs). This retrospective study did not identify any significant prognostic indicators for dogs with recurrent peritonitis and that the mortality rate for dogs having more than one surgery for septic peritonitis is similar to that reported for a single surgery for septic peritonitis. ©Veterinary Emergency and Critical Care Society 2015.

Impact of the Cancer Prevention and Control Research Network: Accelerating the Translation of Research Into Practice.

PubMed

Ribisl, Kurt M; Fernandez, Maria E; Friedman, Daniela B; Hannon, Peggy A; Leeman, Jennifer; Moore, Alexis; Olson, Lindsay; Ory, Marcia; Risendal, Betsy; Sheble, Laura; Taylor, Vicky M; Williams, Rebecca S; Weiner, Bryan J

2017-03-01

The Cancer Prevention and Control Research Network (CPCRN) is a thematic network dedicated to accelerating the adoption of evidence-based cancer prevention and control practices in communities by advancing dissemination and implementation science. Funded by the Centers for Disease Control and Prevention and National Cancer Institute, CPCRN has operated at two levels: Each participating network center conducts research projects with primarily local partners as well as multicenter collaborative research projects with state and national partners. Through multicenter collaboration, thematic networks leverage the expertise, resources, and partnerships of participating centers to conduct research projects collectively that might not be feasible individually. Although multicenter collaboration is often advocated, it is challenging to promote and assess. Using bibliometric network analysis and other graphical methods, this paper describes CPCRN's multicenter publication progression from 2004 to 2014. Searching PubMed, Scopus, and Web of Science in 2014 identified 249 peer-reviewed CPCRN publications involving two or more centers out of 6,534 total. The research and public health impact of these multicenter collaborative projects initiated by CPCRN during that 10-year period were then examined. CPCRN established numerous workgroups around topics such as: 2-1-1, training and technical assistance, colorectal cancer control, federally qualified health centers, cancer survivorship, and human papillomavirus. This paper discusses the challenges that arise in promoting multicenter collaboration and the strategies that CPCRN uses to address those challenges. The lessons learned should broadly interest those seeking to promote multisite collaboration to address public health problems, such as cancer prevention and control. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

The value-based medicine comparative effectiveness and cost-effectiveness of penetrating keratoplasty for keratoconus.

PubMed

Roe, Richard H; Lass, Jonathan H; Brown, Gary C; Brown, Melissa M

2008-10-01

To perform a base case, comparative effectiveness, and cost-effectiveness (cost-utility) analysis of penetrating keratoplasty for patients with severe keratoconus. Visual acuity data were obtained from a large, retrospective multicenter study in which patients with keratoconus with less than 20/40 best corrected visual acuity and/or the inability to wear contact lenses underwent penetrating keratoplasty, with an average follow-up of 2.1 years. The results were combined with other retrospective studies investigating complication rates of penetrating keratoplasty. The data were then incorporated into a cost-utility model using patient preference-based, time trade-off utilities, computer-based decision analysis, and a net present value model to account for the time value of outcomes and money. The comparative effectiveness of the intervention is expressed in quality-of-life gain and QALYs (quality-adjusted life-years), and the cost-effectiveness results are expressed in the outcome of $/QALY (dollars spent per QALY). Penetrating keratoplasty in 1 eye for patients with severe keratoconus results in a comparative effectiveness (value gain) of 16.5% improvement in quality of life every day over the 44-year life expectancy of the average patient with severe keratoconus. Discounting the total value gain of 5.36 QALYs at a 3% annual discount rate yields 3.05 QALYs gained. The incremental cost for penetrating keratoplasty, including all complications, is $5934 ($5913 discounted at 3% per year). Thus, the incremental cost-utility (discounted at 3% annually) for this intervention is $5913/3.05 QALYs = $1942/QALY. If both eyes undergo corneal transplant, the total discounted value gain is 30% and the overall cost-utility is $2003. Surgery on the second eye confers a total discounted value gain of 2.5 QALYs, yielding a quality-of-life gain of 11.6% and a discounted cost-utility of $2238/QALY. Penetrating keratoplasty for patients with severe keratoconus seems to be a comparatively effective and cost-effective procedure when compared with other interventions across different medical specialties.

Multicenter retrospective analysis of systemic chemotherapy for advanced neuroendocrine carcinoma of the digestive system.

PubMed

Yamaguchi, Tomohiro; Machida, Nozomu; Morizane, Chigusa; Kasuga, Akiyoshi; Takahashi, Hideaki; Sudo, Kentaro; Nishina, Tomohiro; Tobimatsu, Kazutoshi; Ishido, Kenji; Furuse, Junji; Boku, Narikazu; Okusaka, Takuji

2014-09-01

This study analyzed outcomes of systemic chemotherapy for advanced neuroendocrine carcinoma (NEC) of the digestive system. Clinical data from 258 patients with unresectable or recurrent NEC of the gastrointestinal tract (GI) or hepato-biliary-pancreatic system (HBP), who received chemotherapy, were collected from 23 Japanese institutions and analyzed retrospectively. Patients had primary sites in the esophagus (n = 85), stomach (n = 70), small bowel (n = 6), colorectum (n = 31), hepato-biliary system (n = 31) and pancreas (n = 31). Median overall survival (OS) was 13.4 months the esophagus, 13.3 months for the stomach, 29.7 months for the small bowel, 7.6 months for the colorectum, 7.9 months for the hepato-biliary system and 8.5 months for the pancreas. Irinotecan plus cisplatin (IP) and etoposide plus cisplatin (EP) were most commonly selected for GI-NEC and HBP-NEC. For patients treated with IP/EP (n = 160/46), the response rate was 50/28% and median OS was 13.0/7.3 months. Multivariate analysis among patients treated with IP or EP showed that the primary site (GI vs HBP; hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.35-0.97) and baseline serum lactate dehydrogenase levels (not elevated vs elevated; HR 0.65, 95% CI 0.46-0.94) were independent prognostic factors for OS, while the efficacy of IP was slightly better than for EP (HR 0.80, 95% CI 0.48-1.33; P = 0.389). IP and EP are the most common treatment regimens for NEC of the digestive system. HBP primary sites and elevated lactate dehydrogenase levels are unfavorable prognostic factors for survival. A randomized controlled trial is required to establish the appropriate chemotherapy regimen for advanced NEC of the digestive system. This study was registered at UMIN as trial number 000005176. © 2014 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Cancer Association.

Are mammographic changes in the tumor bed more pronounced after intraoperative radiotherapy for breast cancer? Subgroup analysis from a randomized trial (TARGIT-A).

PubMed

Engel, Dorothee; Schnitzer, Andreas; Brade, Joachim; Blank, Elena; Wenz, Frederik; Suetterlin, Marc; Schoenberg, Stefan; Wasser, Klaus

2013-01-01

Intraoperative radiotherapy (IORT) with low-energy x-rays is increasingly used in breast-conserving therapy (BCT). Previous non-randomized studies have observed mammographic changes in the tumor bed to be more pronounced after IORT. The purpose of this study was to reassess the postoperative changes in a randomized single-center subgroup of patients from a multicenter trial (TARGIT-A). In this subgroup (n = 48) 27 patients received BCT with IORT, 21 patients had BCT with standard whole-breast radiotherapy serving as controls. Overall 258 postoperative mammograms (median follow-up 4.3 years, range 3-8) were retrospectively evaluated by two radiologists in consensus focusing on changes in the tumor bed. Fat necroses showed to be significantly more frequent (56% versus 24%) and larger (8.7 versus 1.6 sq cm, median) after IORT than those in controls. Scar calcifications were also significantly more frequent after IORT (63% versus 19%). The high incidence of large fat necroses in our study confirms previous study findings. However, the overall higher incidence of calcifications in the tumor bed after IORT represents a new finding, requiring further attention. © 2012 Wiley Periodicals, Inc.

Different clinical response to interferon beta and glatiramer acetate related to the presence of oligoclonal IgM bands in CSF in multiple sclerosis patients.

PubMed

Casanova, Bonaventura; Lacruz, Laura; Villar, María Luisa; Domínguez, José Andrés; Gadea, María Carcelén; Gascón, Francisco; Mallada, Javier; Hervás, David; Simó-Castelló, María; Álvarez-Cermeño, José Carlos; Calles, Carmen; Olascoaga, Javier; Ramió-Torrentà, Lluís; Alcalá, Carmen; Cervelló, Angeles; Boscá, Isabel; Pérez-Mirallles, Francisco Carlos; Coret, Francisco

2018-06-07

To study the efficacy of interferon beta (IFNβ) and glatiramer acetate (GA) related to the presence of oligoclonal M bands (OCMB) in the cerebrospinal fluid in relapsing-remitting multiple sclerosis (RRMS). This is an observational, multicenter and retrospective study with prospectively collected data of patients that started treatment with IFNβ or GA. Treatment decision was made blinded to the OCMB status. Time to first attack after starting therapy was compared by using Kaplan-Meier curves, and adjustment by Cox regression analysis was performed. Two hundred and fifty-six patients entered in the study (141-55% received IFNβ; 115-45% received GA). After a mean follow-up of 41 and 65 months, 54.7% of patients remained free from further attacks (RF). The proportion of RF patients was higher in the GA group than in the IFNβ group (72.2 vs. 40.4%, p < 0.001). The IFNβ patients with OCMB+ presented the poorest response, 31.3% RF vs. 48.1% in IFNβ without OCMB, p = 0.03. OCMB in CSF could be a biomarker of treatment response in multiple sclerosis.

[Alternating hemiplegia of childhood: ATP1A3 gene analysis in 16 patients].

PubMed

Ulate-Campos, Adriana; Fons, Carmen; Campistol, Jaume; Martorell, Loreto; Cancho-Candela, Ramón; Eiris, Jesús; López-Laso, Eduardo; Pineda, Mercedes; Sans, Anna; Velázquez, Ramón

2014-07-07

Alternating hemiplegia in childhood (AHC) is a disease characterized by recurrent episodes of hemiplegia, tonic or dystonic crisis and abnormal ocular movements. Recently, mutations in the ATP1A3 gene have been identified as the causal mechanism of AHC. The objective is to describe a series of 16 patients with clinical and genetic diagnosis of AHC. It is a descriptive, retrospective, multicenter study of 16 patients with clinical diagnosis of AHC in whom mutations in ATP1A3 were identified. Six heterozygous, de novo mutations were found in the ATP1A3 gene. The most frequent mutation was G2401A in 8 patients (50%) followed by G2443A in 3 patients (18.75%), G2893A in 2 patients (12.50%) and C2781G, G2893C and C2411T in one patient, respectively (6.25% each). In the studied population with AHC, de novo mutations were detected in 100% of patients. The most frequent mutations were D801N y la E815K, as reported in other series. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Decompression Surgery Alone Versus Decompression Plus Fusion in Symptomatic Lumbar Spinal Stenosis: A Swiss Prospective Multicenter Cohort Study With 3 Years of Follow-up.

PubMed

Ulrich, Nils H; Burgstaller, Jakob M; Pichierri, Giuseppe; Wertli, Maria M; Farshad, Mazda; Porchet, François; Steurer, Johann; Held, Ulrike

2017-09-15

Retrospective analysis of a prospective, multicenter cohort study. To estimate the added effect of surgical fusion as compared to decompression surgery alone in symptomatic lumbar spinal stenosis patients with spondylolisthesis. The optimal surgical management of lumbar spinal stenosis patients with spondylolisthesis remains controversial. Patients of the Lumbar Stenosis Outcome Study with confirmed DLSS and spondylolisthesis were enrolled in this study. The outcomes of this study were Spinal Stenosis Measure (SSM) symptoms (score range 1-5, best-worst) and function (1-4) over time, measured at baseline, 6, 12, 24, and 36 months follow-up. In order to quantify the effect of fusion surgery as compared to decompression alone and number of decompressed levels, we used mixed effects models and accounted for the repeated observations in main outcomes (SSM symptoms and SSM function) over time. In addition to individual patients' random effects, we also fitted random slopes for follow-up time points and compared these two approaches with Akaike's Information Criterion and the chi-square test. Confounders were adjusted with fixed effects for age, sex, body mass index, diabetes, Cumulative Illness Rating Scale musculoskeletal disorders, and duration of symptoms. One hundred thirty-one patients undergoing decompression surgery alone (n = 85) or decompression with fusion surgery (n = 46) were included in this study. In the multiple mixed effects model the adjusted effect of fusion compared with decompression alone surgery on SSM symptoms was 0.06 (95% confidence interval: -0.16-0.27) and -0.07 (95% confidence interval: -0.25-0.10) on SSM function, respectively. Among the patients with degenerative lumbar spinal stenosis and spondylolisthesis our study confirms that in the two groups, decompression alone and decompression with fusion, patients distinctively benefited from surgical treatment. When adjusted for confounders, fusion surgery was not associated with a more favorable outcome in both SSM scores as compared to decompression alone surgery. 3.

Is the timing of surgery associated with avascular necrosis after unstable slipped capital femoral epiphysis? A multicenter study.

PubMed

Kohno, Yusuke; Nakashima, Yasuharu; Kitano, Toshio; Irie, Taichi; Kita, Atsushi; Nakamura, Tomoyuki; Endo, Hirosuke; Fujii, Yosuke; Kuroda, Takayuki; Mitani, Shigeru; Kitoh, Hiroshi; Matsushita, Masaki; Hattori, Tadashi; Iwata, Koji; Iwamoto, Yukihide

2017-01-01

An unstable slipped capital femoral epiphysis (SCFE) is associated with a high rate of avascular necrosis (AVN). The etiology of AVN seems to be multifactorial, although it is not thoroughly known. The aims of our study were to determine the rate of AVN after an unstable SCFE and to investigate the risk factors for AVN, specifically evaluating the notion of an "unsafe window", during which medical interventions would increase the risk for AVN. This retrospective multicenter study included 60 patients with an unstable SCFE diagnosed between 1985 and 2014. Timing of surgery was evaluated for three time periods, from acute onset of symptoms to surgery: period I, <24 h; period II, between 24 h and 7 days; and period III, >7 days. Multivariate logistic regression analysis was used to identify risk factors for AVN. Closed reduction and pinning was performed in 43 patients and in situ pinning in 17. Among these cases, 16 patients (27%) developed AVN. The rate of AVN was significantly higher in patients treated by closed reduction and pinning (15/43, 35%) than in those treated by in situ pinning (1/17, 5.9%) (p = 0.022). In patients treated by closed reduction and pinning, the incidence of AVN was 2/11 (18%) in period I, 10/13 (77%) in period II and 3/15 (20%) in period III, showing the significantly higher rate in period II (p = 0.002). The surgery provided in period II was identified as an independent risk factor for the development of AVN. Our rate of AVN was 27% using two classical treatment methods. Time-to-surgery, between 24 h and 7 days, was independently associated with AVN, supporting the possible existence of an "unsafe window" in patients with unstable SCFE treated by closed reduction and pinning. Copyright © 2016 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

Laparoscopic surgery for colorectal cancer is safe and has survival outcomes similar to those of open surgery in elderly patients with a poor performance status: subanalysis of a large multicenter case-control study in Japan.

PubMed

Niitsu, Hiroaki; Hinoi, Takao; Kawaguchi, Yasuo; Ohdan, Hideki; Hasegawa, Hirotoshi; Suzuka, Ichio; Fukunaga, Yosuke; Yamaguchi, Takashi; Endo, Shungo; Tagami, Soichi; Idani, Hitoshi; Ichihara, Takao; Watanabe, Kazuteru; Watanabe, Masahiko

2016-01-01

It remains controversial whether open or laparoscopic surgery should be indicated for elderly patients with colorectal cancer and a poor performance status. In those patients aged 80 years or older with Eastern Cooperative Oncology Group performance status score of 2 or greater who received elective surgery for stage 0 to stage III colorectal adenocarcinoma and had no concomitant malignancies and who were enrolled in a multicenter case-control study entitled "Retrospective study of laparoscopic colorectal surgery for elderly patients" that was conducted in Japan between 2003 and 2007, background characteristics and short-term and long-term outcomes for open surgery and laparoscopic surgery were compared. Of the 398 patients included, 295 underwent open surgery and 103 underwent laparoscopic surgery. There were no significant differences in the baseline characteristics between open surgery and laparoscopic surgery patients, except for previous abdominal surgery and TNM stage. The median operation duration was shorter with open surgery (open surgery, 153 min; laparoscopic surgery, 202 min; P < 0.001), and less blood loss occurred with laparoscopic surgery (median open surgery, 109 g; median laparoscopic surgery, 30 g; P < 0.001). An operation duration of 180 min or more (odds ratio, 1.97; 95 % confidence interval, 1.17-3.37; P = 0.011) and selection of laparoscopic surgery (odds ratio, 0.41; 95 % confidence interval, 0.22-0.75; P = 0.003) were statistically significant in the multivariate analysis for postoperative morbidity. Moreover, laparoscopic surgery did not result in an inferior overall survival rate compared with open surgery (log-rank test P = 0.289, 0.278, 0.346, 0.199, for all-stage, stage 0-I, stage II, and stage III disease, respectively). Laparoscopic surgery in elderly colorectal cancer patients with a poor performance status is safe and not inferior to open surgery in terms of overall survival.

Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy. A multicenter prospective 8 years follow up study.

PubMed

Sasso, Ferdinando Carlo; Lascar, Nadia; Ascione, Antonella; Carbonara, Ornella; De Nicola, Luca; Minutolo, Roberto; Salvatore, Teresa; Rizzo, Maria Rosaria; Cirillo, Plinio; Paolisso, Giuseppe; Marfella, Raffaele

2016-10-13

Although numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention. We conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B). Notably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012). These findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy. Trial registration ClinicalTrials.gov Identifier NCT00535925. Date of registration: September 24, 2007, retrospectively registered.

Efficacy of the unified protocol for the treatment of emotional disorders in the Spanish public mental health system using a group format: study protocol for a multicenter, randomized, non-inferiority controlled trial.

PubMed

Osma, Jorge; Suso-Ribera, Carlos; García-Palacios, Azucena; Crespo-Delgado, Elena; Robert-Flor, Cristina; Sánchez-Guerrero, Ana; Ferreres-Galan, Vanesa; Pérez-Ayerra, Luisa; Malea-Fernández, Amparo; Torres-Alfosea, Mª Ángeles

2018-03-12

Emotional disorders, which include both anxiety and depressive disorders, are the most prevalent psychological disorders according to recent epidemiological studies. Consequently, public costs associated with their treatment have become a matter of concern for public health systems, which face long waiting lists. Because of their high prevalence in the population, finding an effective treatment for emotional disorders has become a key goal of today's clinical psychology. The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders might serve the aforementioned purpose, as it can be applied to a variety of disorders simultaneously and it can be easily performed in a group format. The study is a multicenter, randomized, non-inferiority controlled clinical trial. Participants will be 220 individuals with emotional disorders, who are randomized to either a treatment as usual (individual cognitive behavioral therapy) or to a Unified Protocol condition in group format. Depression, anxiety, and diagnostic criteria are the primary outcome measures. Secondary measures include the assessment of positive and negative affect, anxiety control, personality traits, overall adjustment, and quality of life. An analysis of treatment satisfaction is also conducted. Assessment points include baseline, post-treatment, and three follow-ups at 3, 6, and 12 months. To control for missing data and possible biases, intention-to-treat and per-protocol analyses will be performed. This is the first randomized, controlled clinical trial to test the effectiveness of a transdiagnostic intervention in a group format for the treatment of emotional disorders in public settings in Spain. Results obtained from this study may have important clinical, social, and economic implications for public mental health settings in Spain. Retrospectively registered at https://clinicaltrials.gov/ . Trial NCT03064477 (March 10, 2017). The trial is active and recruitment is ongoing. Recruitment is expected to finish by January 2020.

A 12-week randomized, double-blind, placebo-controlled multicenter study of choline-stabilized orthosilicic acid in patients with symptomatic knee osteoarthritis.

PubMed

Geusens, Piet; Pavelka, Karel; Rovensky, Jozef; Vanhoof, Johan; Demeester, Nathalie; Calomme, Mario; Vanden Berghe, Dirk

2017-01-05

The aim of this study was to assess the efficacy of choline-stabilized orthosilicic acid (ch-OSA) in patients with symptomatic knee osteoarthritis (OA). In a multicenter, double-blind, placebo-controlled study, 211 patients with knee OA (Kellgren and Lawrence grade II or III) and moderate to moderately severe pain were randomly allocated to ch-OSA or placebo for 12 weeks. The primary outcome was the change in the WOMAC pain subscale from baseline to week 12. Secondary outcomes were changes from baseline to week 12 in WOMAC total, WOMAC stiffness, WOMAC physical function, Subject Global Assessment and levels of cartilage degradation biomarkers C-terminal telopeptide of collagen type II (CTX-II) and cartilage oligomeric matrix protein (COMP). Pre-specified subgroup analyses included the effect of gender. A total of 166 (120 women, 46 men) patients were included in the analysis (87 and 79 in the ch-OSA and placebo group, respectively). In the total study population, no differences were observed between the two treatment groups for the different outcomes but significant treatment x gender interactions were found. In men taking ch-OSA, a significant improvement in WOMAC total, WOMAC stiffness and WOMAC physical function as well as a lower increase in biomarker levels of cartilage degradation was observed, but not in women. The change in WOMAC pain showed a similar positive trend in men taking ch-OSA. After 12 weeks of treatment, no effect was found of ch-OSA in the total study population on clinical parameters and biomarkers, but a gender interaction was observed. In men, ch-OSA was found effective in reducing symptoms of knee OA, which was associated with a slight but significant reduction of biomarkers that are related to cartilage degradation. The study was registered retrospectively: ISRCTN88583133 . Registration date: 2015-10-07.

77 FR 47572 - Retrospective Analysis of Existing Rules

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-09

... INTERNATIONAL TRADE COMMISSION 19 CFR Chapter II Retrospective Analysis of Existing Rules AGENCY... Order 13579 of July 11, 2011, the Commission recently adopted its Plan for Retrospective Analysis of... submitted in connection with the Commission's Preliminary Plan for Retrospective Analysis of Existing Rules...

A Multi-center Comparison of the Safety of Oral versus Intravenous Acetylcysteine for Treatment of Acetaminophen Overdose

PubMed Central

2010-01-01

Oral and intravenous (IV) acetylcysteine are used for treatment of acetaminophen poisoning. The objective of this multi-center study was to compare the safety of these two routes of administration. METHODS We conducted a multi-center chart review of all patients treated with acetylcysteine for acetaminophen poisoning. The primary safety outcome was the percentage of patients with of acetylcysteine-related adverse events. RESULTS A total of 503 subjects were included in the safety analysis (306 IV only, 145 oral only and 52 both routes).There were no serious adverse events related to acetylcysteine for either route. Nausea and vomiting were the most common related adverse events and were more common with oral treatment (23% vs 9%). Anaphylactoid reactions were more common with IV administration (6% vs 2%). Conclusions Intravenous and oral acetylcysteine are both associated with minimal side effects and are safe for treatment of acetaminophen toxicity. PMID:20524832

Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

PubMed

Walden, Anita; Nahm, Meredith; Barnett, M Edwina; Conde, Jose G; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E; Eisenstein, Eric L

2011-01-01

New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

Economic Analysis of Centralized vs. Decentralized Electronic Data Capture in Multi-Center Clinical Studies

PubMed Central

Walden, Anita; Nahm, Meredith; Barnett, M. Edwina; Conde, Jose G.; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E.; Eisenstein, Eric L.

2012-01-01

Background New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. Methods We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. Main Outcome Measures The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Results Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Conclusion Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs. PMID:21335692

Hospitalization rates in patients switched from oral anti-psychotics to aripiprazole once-monthly: final efficacy analysis

PubMed Central

Kane, John M.; Zhao, Cathy; Johnson, Brian R.; Baker, Ross A.; Eramo, Anna; McQuade, Robert D.; Duca, Anna R.; Sanchez, Raymond; Peters-Strickland, Timothy

2015-01-01

Abstract Objective: To compare hospitalization rates in patients with schizophrenia treated prospectively with aripiprazole once-monthly 400 mg (AOM 400; an extended-release injectable suspension) vs the same patients’ retrospective rates with their prior oral anti-psychotic therapy. Research design and methods: Multi-center, open-label, mirror-image, naturalistic study in a community setting in North America. Patients who required a change in treatment and/or would benefit from long-acting injectable anti-psychotic therapy were treated prospectively for 6 months with AOM 400. Retrospective data on hospitalization rates were obtained. Clinical trial registration: ClinicalTrials.gov: NCT01432444. Main outcome measures: The proportion of patients with ≥1 psychiatric inpatient hospitalization with oral anti-psychotic therapy examined retrospectively (months –4 to –1 before oral conversion) and after switching to AOM 400 (months 4–6 after initiating AOM 400). Results: Psychiatric hospitalization rates were significantly lower when patients were treated with AOM 400 compared with oral anti-psychotic therapy both in the 3-month primary efficacy sample (2.7% [n = 9/336] vs 27.1% [n = 91/336], respectively; p < 0.0001) and in the total sample (6-month prospective rate: 8.8% [n = 38/433] vs 6-month retrospective rate: 38.1% [n = 165/433]; p < 0.0001). Discontinuations due to adverse events (AEs) during cross-titration were lower in patients cross-titrated on oral aripiprazole for >1 and <4 weeks (2.9% [n = 7/239]) compared with patients cross-titrated for ≤1 week (10.4% [n = 5/48]). The most common treatment-emergent AEs during the prospective treatment phase were insomnia (6.7% [n = 29/431]) and akathisia (6.5% [n = 28/431]). Patient-rated injection-site pain decreased from the first injection to the last visit. Conclusions: In a community setting, patients with schizophrenia demonstrated significantly lower psychiatric hospitalization rates after switching from their prior oral anti-psychotic therapy to AOM 400. Patients served as their own control, and thus an active control group was not included in this study. Confounding factors, such as insurance coverage and availability of hospital beds, were not examined here and deserve further consideration. PMID:25347448

A nationwide survey of hypoplastic myelodysplastic syndrome (a multicenter retrospective study).

PubMed

Kobayashi, Takashi; Nannya, Yasuhito; Ichikawa, Motoshi; Oritani, Kenji; Kanakura, Yuzuru; Tomita, Akihiro; Kiyoi, Hitoshi; Kobune, Masayoshi; Kato, Junji; Kawabata, Hiroshi; Shindo, Motohiro; Torimoto, Yoshihiro; Yonemura, Yuji; Hanaoka, Nobuyoshi; Nakakuma, Hideki; Hasegawa, Daisuke; Manabe, Atsushi; Fujishima, Naohito; Fujii, Nobuharu; Tanimoto, Mitsune; Morita, Yasuyoshi; Matsuda, Akira; Fujieda, Atsushi; Katayama, Naoyuki; Ohashi, Haruhiko; Nagai, Hirokazu; Terada, Yoshiki; Hino, Masayuki; Sato, Ken; Obara, Naoshi; Chiba, Shigeru; Usuki, Kensuke; Ohta, Masatsugu; Imataki, Osamu; Uemura, Makiko; Takaku, Tomoiku; Komatsu, Norio; Kitanaka, Akira; Shimoda, Kazuya; Watanabe, Kenichiro; Tohyama, Kaoru; Takaori-Kondo, Akifumi; Harigae, Hideo; Arai, Shunya; Miyazaki, Yasushi; Ozawa, Keiya; Kurokawa, Mineo

2017-12-01

Hypoplastic myelodysplastic syndrome (hMDS) is a distinct entity with bone marrow (BM) hypocellularity and the risk of death from BM failure (BMF). To elucidate the characteristics of hMDS, the data of 129 patients diagnosed between April 2003 and March 2012 were collected from 20 institutions and the central review team of the National Research Group on Idiopathic Bone Marrow Failure Syndromes, and compared with 115 non-hMDS patients. More RA and fewer CMMoL and RAEB-t in French-American-British (FAB) and more RCUD and MDS-U and fewer RCMD in World Health Organization (WHO) classifications were found in hMDS than non-hMDS with significant differences. The overall survival (OS) and AML progression-free survival (AML-PFS) of hMDS were higher than those of non-hMDS, especially in patients at age ≥50 and of lower risk in Revised International Prognostic Scoring System (IPSS-R). In competing risks analysis, hMDS exhibited decreased risk of AML-progression in lower IPSS or IPSS-R risk patients, and higher risk of death from BMF in patients at age ≥50. Poor performance status (PS ≥2) and high karyotype risks in IPSS-R (high and very high) were significant risk factors of death and AML-progression in Cox proportional hazards analysis. © 2017 Wiley Periodicals, Inc.

Outcomes assessment in the SPRINT multicenter tibial fracture trial: Adjudication committee size has trivial effect on trial results.

PubMed

Simunovic, Nicole; Walter, Stephen; Devereaux, P J; Sprague, Sheila; Guyatt, Gordon H; Schemitsch, Emil; Tornetta, Paul; Sanders, David; Swiontkowski, Marc; Bhandari, Mohit

2011-09-01

To evaluate how the size of an outcome adjudication committee, and the potential for dominance among its members, potentially impacts a trial's results. We conducted a retrospective analysis of data from the six-member adjudication committee in the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) Trial. We modeled the adjudication process, predicted the results and costs if smaller committees had been used, and tested for the presence of a dominant adjudicator. Use of smaller committee sizes (one to five members) would have had little impact on the final study results, although one analysis suggested that the benefit in reduction of reoperations with reamed nails in closed tibial fractures would have lost significance if committee sizes of three or less were used. We identified a significant difference between adjudicators in the number of times their original minority decisions became the final consensus decision (χ(2)=9.67, P=0.046), suggesting that dominant adjudicators were present. However, their impact on the final study results was trivial. Reducing the number of adjudicators from six to four would have led to little change in the final SPRINT study results irrespective of the significance of the original trial results, demonstrating the potential for savings in trial resources. Copyright © 2011 Elsevier Inc. All rights reserved.

Very low rate of readmission after an early discharge outpatient model for autografting in multiple myeloma patients: an Italian multicenter retrospective study.

PubMed

Martino, Massimo; Montanari, Mauro; Ferrara, Felicetto; Ciceri, Fabio; Scortechini, Ilaria; Palmieri, Salvatore; Marktel, Sarah; Cimminiello, Michele; Messina, Giuseppe; Irrera, Giuseppe; Offidani, Massimo; Console, Giuseppe; Castagna, Luca; Milone, Giuseppe; Bruno, Benedetto; Tripepi, Giovanni; Lemoli, Roberto Massimo; Olivieri, Attilio

2014-07-01

We analyzed the main modalities and clinical outcomes of the early discharge outpatient model in autologous stem cell transplantation (EDOM-ASCT) for multiple myeloma in Italy. EDOM-ASCT was employed in 382 patients, for a total of 522 procedures, between 1998 and 2012. Our study showed high homogeneity among centers in terms of inclusion criteria, supportive care, and in hospital readmission criteria. Overall, readmissions during the aplastic phase occurred in 98 of 522 transplantations (18.8%). The major extrahematological complication was neutropenic fever in 161 cases (30.8%), which required readmission in 76 cases. The incidence of severe World Health Organization grade 3 to 4 mucositis was 9.6%. By univariate analysis, fever, mucositis, altered renal function at diagnosis, second transplantation, and transplantation performed late in the course of the disease were significantly correlated with readmission, whereas fever, mucositis, altered renal function, and timing of transplantation remained the only independent predictors by multivariate analysis. Overall, transplantation-related mortality was 1.0%. No center effect was observed in this study (P = .36). The safety and low rate of readmission of the EDOM-ASCT in myeloma trial suggest that this strategy could be extended to other transplantation centers if a stringent patient selection and appropriate management are applied. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Analysis of maxillofacial prosthetics at university dental hospitals in the capital region of Korea

PubMed Central

Lee, Jong-Ho

2016-01-01

PURPOSE The purpose of this study was to investigate the demographic patterns of maxillofacial prosthetic treatment to identify the characteristics and geographic distribution of patients with maxillofacial prosthetics in the capital region of Korea. MATERIALS AND METHODS This retrospective analytical multicenter study was performed by chart reviews. This study included patients who visited the department of prosthodontics at four university dental hospitals for maxillofacial prosthetic rehabilitation. Patients with facial and congenital defects or with insufficient medical data were excluded. The patients were classified into three categories based on the location of the defect. Patients' sex, age, and residential area were analyzed. Pearson's chi-square test with a significance level of 0.05 was used to analyze the variables. RESULTS Among 540 patients with maxillofacial prosthetics, there were 284 (52.59%) male patients and 256 (47.41%) female patients. The number of the patients varied greatly by hospital. Most patients were older than 70, and the most common defect was a hard palate defect. Chi-square analysis did not identify any significant differences in sex, age, and distance to hospital for any defect group (P>.05). CONCLUSION The results of this study indicated that there was imbalance in the distribution of patients with maxillofacial prosthetic among the hospitals in the capital region of Korea. Considerations on specialists and insurance policies for the improvement of maxillofacial prosthetics in Korea are required. PMID:27350859

Terminal patients in Belgian nursing homes: a cost analysis.

PubMed

Simoens, Steven; Kutten, Betty; Keirse, Emmanuel; Vanden Berghe, Paul; Beguin, Claire; Desmedt, Marianne; Deveugele, Myriam; Léonard, Christian; Paulus, Dominique; Menten, Johan

2013-06-01

Policy makers and health care payers are concerned about the costs of treating terminal patients. This study was done to measure the costs of treating terminal patients during the final month of life in a sample of Belgian nursing homes from the health care payer perspective. Also, this study compares the costs of palliative care with those of usual care. This multicenter, retrospective cohort study enrolled terminal patients from a representative sample of nursing homes. Health care costs included fixed nursing home costs, medical fees, pharmacy charges, other charges, and eventual hospitalization costs. Data sources consisted of accountancy and invoice data. The analysis calculated costs per patient during the final month of life at 2007/2008 prices. Nineteen nursing homes participated in the study, generating a total of 181 patients. Total mean nursing home costs amounted to 3,243 € per patient during the final month of life. Total mean nursing home costs per patient of 3,822 € for patients receiving usual care were higher than costs of 2,456 € for patients receiving palliative care (p = 0.068). Higher costs of usual care were driven by higher hospitalization costs (p < 0.001). This study suggests that palliative care models in nursing homes need to be supported because such care models appear to be less expensive than usual care and because such care models are likely to better reflect the needs of terminal patients.

Factors related to clinical pregnancy after vitrified-warmed embryo transfer: a retrospective and multivariate logistic regression analysis of 2313 transfer cycles.

PubMed

Shi, Wenhao; Zhang, Silin; Zhao, Wanqiu; Xia, Xue; Wang, Min; Wang, Hui; Bai, Haiyan; Shi, Juanzi

2013-07-01

What factors does multivariate logistic regression show to be significantly associated with the likelihood of clinical pregnancy in vitrified-warmed embryo transfer (VET) cycles? Assisted hatching (AH) and if the reason to freeze embryos was to avoid the risk of ovarian hyperstimulation syndrome (OHSS) were significantly positively associated with a greater likelihood of clinical pregnancy. Single factor analysis has shown AH, number of embryos transferred and the reason of freezing for OHSS to be positively and damaged blastomere to be negatively significantly associated with the chance of clinical pregnancy after VET. It remains unclear what factors would be significant after multivariate analysis. The study was a retrospective analysis of 2313 VET cycles from 1481 patients performed between January 2008 and April 2012. A multivariate logistic regression analysis was performed to identify the factors to affect clinical pregnancy outcome of VET. There were 22 candidate variables selected based on clinical experiences and the literature. With the thresholds of α entry = α removal= 0.05 for both variable entry and variable removal, eight variables were chosen to contribute the multivariable model by the bootstrap stepwise variable selection algorithm (n = 1000). Eight variables were age at controlled ovarian hyperstimulation (COH), reason for freezing, AH, endometrial thickness, damaged blastomere, number of embryos transferred, number of good-quality embryos, and blood presence on transfer catheter. A descriptive comparison of the relative importance was accomplished by the proportion of explained variation (PEV). Among the reasons for freezing, the OHSS group showed a higher OR than the surplus embryo group when compared with other reasons for VET groups (OHSS versus Other, OR: 2.145; CI: 1.4-3.286; Surplus embryos versus Other, OR: 1.152; CI: 0.761-1.743) and high PEV (marginal 2.77%, P = 0.2911; partial 1.68%; CI of area under receptor operator characteristic curve (ROC): 0.5576-0.6000). AH also showed a high OR (OR: 2.105, CI: 1.554-2.85) and high PEV (marginal 1.97%; partial 1.02%; CI of area under ROC: 0.5344-0.5647). The number of good-quality embryos showed the highest marginal PEV and partial PEV (marginal 3.91%, partial 2.28%; CI of area under ROC: 0.5886-0.6343). This was a retrospective multivariate analysis of the data obtained in 5 years from a single IVF center. Repeated cycles in the same woman were treated as independent observations, which could introduce bias. Results are based on clinical pregnancy and not live births. Prospective analysis of a larger data set from a multicenter study based on live births is necessary to confirm the findings. Paying attention to the quality of embryos, the number of good embryos, AH and the reasons for freezing that are associated with clinical pregnancy after VET will assist the improvement of success rates.

Extrapleural pneumonectomy for malignant mesothelioma: an Italian multicenter retrospective study.

PubMed

Spaggiari, Lorenzo; Marulli, Giuseppe; Bovolato, Pietro; Alloisio, Marco; Pagan, Vittore; Oliaro, Alberto; Ratto, Giovanni Battista; Facciolo, Francesco; Sacco, Rocco; Brambilla, Daniela; Maisonneuve, Patrick; Mucilli, Felice; Alessandrini, Gabriele; Leoncini, Giacomo; Ruffini, Enrico; Fontana, Paolo; Infante, Maurizio; Pariscenti, Gian Luca; Casiraghi, Monica; Rea, Federico

2014-06-01

This study assessed perioperative outcome and long-term survival in a large series of patients with malignant pleural mesothelioma who underwent extrapleural pneumonectomy (EPP) to identify prognostic factors allowing better patient selection. We retrospectively collected data from nine referral centers for thoracic surgery in Italy. Perioperative outcome and survival data were available for 518 malignant pleural mesothelioma patients (84.4% with epithelial tumors, 68.0% with pathologic stage 3 disease) who underwent EPP with intention-to-treat (R0/R1) between 2000 and 2010. Induction chemotherapy was administered in 271 patients (52.3%) and adjuvant therapy in 373 patients (72.0%), including radiotherapy in 213 patients (41.1%), adjuvant chemotherapy in 43 patients (8.3%), and both in 117 patients (22.6%). In all, 136 patients (26.3%) had major complications after EPP, and 36 (6.9%) died within 90 days after surgery. The median overall survival was 18 months, with a 1-, 2-, and 3-year overall survival of 65%, 41%, and 27%, respectively. At multivariable analysis adjusted for age and disease stage, male sex (hazard ratio [HR] 1.47, 95% confidence interval [CI]: 1.12 to 1.92), nonepithelial histology (HR 1.96, 95% CI: 1.48 to 2.58), and trimodality treatment using induction chemotherapy (HR 0.61, 95% CI: 0.43 to 0.85) were significantly associated with survival. Development of a major complication also significantly worsened outcome (HR 1.85, 95% CI: 1.37 to 2.50). The success of EPP in the context of a multimodality treatment depends on a series of patient characteristics. Female patients, patients with epithelial tumors, and patients who received induction chemotherapy will best benefit from EPP. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Multicenter retrospective analysis of metastatic colorectal cancer (CRC) with high-level microsatellite instability (MSI-H).

PubMed

Goldstein, J; Tran, B; Ensor, J; Gibbs, P; Wong, H L; Wong, S F; Vilar, E; Tie, J; Broaddus, R; Kopetz, S; Desai, J; Overman, M J

2014-05-01

The microsatellite instability-high (MSI-H) phenotype, present in 15% of early colorectal cancer (CRC), confers good prognosis. MSI-H metastatic CRC is rare and its impact on outcomes is unknown. We describe survival outcomes and the impact of chemotherapy, metastatectomy, and BRAF V600E mutation status in the largest reported cohort of MSI-H metastatic colorectal cancer (CRC). A retrospective review of 55 MSI-H metastatic CRC patients from two institutions, Royal Melbourne Hospital (Australia) and The University of Texas MD Anderson Cancer Center (United States), was conducted. Statistical analyses utilized Kaplan-Meier method, Log-rank test, and Cox proportional hazards models. Median age was 67 years (20-90), 58% had poor differentiation, and 45% had stage IV disease at presentation. Median overall survival (OS) from metastatic disease was 15.4 months. Thirteen patients underwent R0/R1 metastatectomies, with median OS from metastatectomy 33.8 months. Thirty-one patients received first-line systemic chemotherapy for metastatic disease with median OS from the start of chemotherapy 11.5 months. No statistically significant difference in progression-free survival or OS was seen between fluoropyrimidine, oxaliplatin, or irinotecan based chemotherapy. BRAF V600E mutation was present in 14 of 47 patients (30%). BRAF V600E patients demonstrated significantly worse median OS; 10.1 versus 17.3 months, P = 0.03. In multivariate analyses, BRAF V600E mutants had worse OS (HR 4.04; P = 0.005), while patients undergoing metastatectomy (HR 0.11; P = <0.001) and patients who initially presented as stage IV disease had improved OS (HR 0.27; P = 0.003). Patients with MSI-H metastatic CRC do not appear to have improved outcomes. BRAF V600E mutation is a poor prognostic factor in MSI-H metastatic CRC.

Effect of roughened micro-threaded implant neck 
and platform switching on marginal bone loss: 
a multicenter retrospective study with 6-year follow-up.

PubMed

Di Stefano, Danilo Alessio; Giacometti, Edoardo; Greco, Gian Battista; Gastaldi, Giorgio; Gherlone, Enrico

2016-01-01

The aim of this retrospective study was to evaluate medium-term marginal peri-implant bone loss following placement of root-form implants featuring a micro-threaded rough-surfaced neck and a platform-switched implant-abutment connection. Records were identified of patients treated with such implants over a 3-year period at three Italian dental centers. Patient radiographs were digitized and subjected to computerized analysis of peri-implant bone resorption. Records of 112 patients who received 257 implants were analyzed. Although implant diameters and lengths varied, all had a 0.3-mm platform-switching width and a 2.5-mm high micro-threaded neck. All patients healed uneventfully, and no peri-implant infection, implant mobility, or radiolucency around the implant were detected at any follow-up control. At the 72-month control (average 71 ± 5 months) all implants were successful according to Albrektsson and Zarb's criteria. At implant level, average peri-implant bone resorption was 0.18 ± 0.12 mm at 6 months, 0.22 ± 0.15 mm at 12 months, 0.23 ± 0.16 mm at 24 months, 0.25 ± 0.17 mm at 36 months, 0.26 ± 0.15 mm at 48 months, and stable at subsequent controls, regardless of the implant diameter and length. At patient level, a similar trend was observed, with crestal bone loss stabilizing from 48 months onward. The surface, geometry, and platform-switching features of the implant under investigation allowed effective bone preservation on a medium-term basis.

A 2011 Updated Systematic Review and Clinical Practice Guideline for the Management of Malignant Extradural Spinal Cord Compression

DOE Office of Scientific and Technical Information (OSTI.GOV)

Loblaw, D. Andrew, E-mail: andrew.loblaw@sunnybrook.ca; Mitera, Gunita; Ford, Michael

2012-10-01

Purpose: To update the 2005 Cancer Care Ontario practice guidelines for the diagnosis and treatment of adult patients with a suspected or confirmed diagnosis of extradural malignant spinal cord compression (MESCC). Methods: A review and analysis of data published from January 2004 to May 2011. The systematic literature review included published randomized control trials (RCTs), systematic reviews, meta-analyses, and prospective/retrospective studies. Results: An RCT of radiation therapy (RT) with or without decompressive surgery showed improvements in pain, ambulatory ability, urinary continence, duration of continence, functional status, and overall survival. Two RCTs of RT (30 Gy in eight fractions vs. 16more » Gy in two fractions; 16 Gy in two fractions vs. 8 Gy in one fraction) in patients with a poor prognosis showed no difference in ambulation, duration of ambulation, bladder function, pain response, in-field failure, and overall survival. Retrospective multicenter studies reported that protracted RT schedules in nonsurgical patients with a good prognosis improved local control but had no effect on functional or survival outcomes. Conclusions: If not medically contraindicated, steroids are recommended for any patient with neurologic deficits suspected or confirmed to have MESCC. Surgery should be considered for patients with a good prognosis who are medically and surgically operable. RT should be given to nonsurgical patients. For those with a poor prognosis, a single fraction of 8 Gy should be given; for those with a good prognosis, 30 Gy in 10 fractions could be considered. Patients should be followed up clinically and/or radiographically to determine whether a local relapse develops. Salvage therapies should be introduced before significant neurologic deficits occur.« less

LabRS: A Rosetta stone for retrospective standardization of clinical laboratory test results.

PubMed

Hauser, Ronald George; Quine, Douglas B; Ryder, Alex

2018-02-01

Clinical laboratories in the United States do not have an explicit result standard to report the 7 billion laboratory tests results they produce each year. The absence of standardized test results creates inefficiencies and ambiguities for secondary data users. We developed and tested a tool to standardize the results of laboratory tests in a large, multicenter clinical data warehouse. Laboratory records, each of which consisted of a laboratory result and a test identifier, from 27 diverse facilities were captured from 2000 through 2015. Each record underwent a standardization process to convert the original result into a format amenable to secondary data analysis. The standardization process included the correction of typos, normalization of categorical results, separation of inequalities from numbers, and conversion of numbers represented by words (eg, "million") to numerals. Quality control included expert review. We obtained 1.266 × 109 laboratory records and standardized 1.252 × 109 records (98.9%). Of the unique unstandardized records (78.887 × 103), most appeared <5 times (96%, eg, typos), did not have a test identifier (47%), or belonged to an esoteric test with <100 results (2%). Overall, these 3 reasons accounted for nearly all unstandardized results (98%). Current results suggest that the tool is both scalable and generalizable among diverse clinical laboratories. Based on observed trends, the tool will require ongoing maintenance to stay current with new tests and result formats. Future work to develop and implement an explicit standard for test results would reduce the need to retrospectively standardize test results. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Real-world Efficacy and Safety of Nivolumab for Advanced Non-Small-cell Lung Cancer: A Retrospective Multicenter Analysis.

PubMed

Kobayashi, Keigo; Nakachi, Ichiro; Naoki, Katsuhiko; Satomi, Ryosuke; Nakamura, Morio; Inoue, Takashi; Tateno, Hiroki; Sakamaki, Fumio; Sayama, Koichi; Terashima, Takeshi; Koh, Hidefumi; Abe, Takayuki; Nishino, Makoto; Arai, Daisuke; Yasuda, Hiroyuki; Kawada, Ichiro; Soejima, Kenzo; Betsuyaku, Tomoko

2018-05-01

Nivolumab, an immune checkpoint inhibitor, is now a standard treatment for previously treated advanced non-small-cell lung cancer based on the results from phase III clinical trials. We evaluated the real-world efficacy and safety of nivolumab in a nonselected population and identified the clinical characteristics that influence efficacy. A total of 142 patients with advanced non-small-cell lung cancer who were administered nivolumab at Keio University and affiliated hospitals in Japan from January to July 2016 were enrolled. The treatment efficacy and adverse events were retrospectively reviewed, and the clinical characteristics associated with the nivolumab response were evaluated using univariate and stratified analyses and the Cochran-Mantel-Haenszel test. The objective response rate was 17.0% (95% confidence interval [CI], 12.0%-24.0%), the median progression-free survival (PFS) was 58 days (95% CI, 50-67 days), and the proportion of patients with adverse events of any grade was 45.0%. EGFR/ALK mutation status was inversely associated with the treatment response (P < .05), and the difference in PFS for the mutation-positive versus mutation-negative patients was statistically significant (49 vs. 63 days; hazard ratio, 1.9; 95% CI, 1.1-5.2; P = .029). Previous radiotherapy also had a positive association with the treatment response (P = .012). The objective response rate, PFS, and adverse event profiles were comparable to those observed in previous clinical trials. EGFR/ALK mutation-negative status and previous radiotherapy might be key clinical characteristics associated with a positive treatment response. Our findings could aid in the efficient immunotherapeutic management of lung cancer. Copyright © 2018 Elsevier Inc. All rights reserved.

Efficacy and safety of nivolumab in previously treated patients with non-small cell lung cancer: A multicenter retrospective cohort study.

PubMed

Fujimoto, Daichi; Yoshioka, Hiroshige; Kataoka, Yuki; Morimoto, Takeshi; Kim, Young Hak; Tomii, Keisuke; Ishida, Tadashi; Hirabayashi, Masataka; Hara, Satoshi; Ishitoko, Manabu; Fukuda, Yasushi; Hwang, Moon Hee; Sakai, Naoki; Fukui, Motonari; Nakaji, Hitoshi; Morita, Mitsunori; Mio, Tadashi; Yasuda, Takehiro; Sugita, Takakazu; Hirai, Toyohiro

2018-05-01

Nivolumab has been shown to be effective and safe in previously treated patients with advanced non-small cell lung cancer (NSCLC). However, little is known regarding its performance in real-world (i.e., non-trial) settings. Furthermore, nivolumab efficacy is unknown in patients who are ineligible for clinical trials or who are categorized into small subgroups in such trials. We conducted a 15-center, observational, retrospective cohort study of patients with advanced NSCLC who received nivolumab monotherapy between January and December 2016. Of 613 patients included in our study, 141 had poor performance status (PS) and 106 were EGFR mutation - or ALK rearrangement-positive. The response and disease control rates were 20% and 44%, respectively; the estimated 1-year progression-free survival (PFS) was 18%. Multivariate analysis identified never smoking, poor PS, and EGFR mutation/ALK rearrangement as independent negative predictors of PFS. The most frequently reported grade ≥3 adverse event was pneumonitis (5% of patients). Severe pneumonitis (grade ≥3) occurred significantly earlier than mild pneumonitis (1.6 vs. 2.3 months, P = 0.031). Patients with pneumonitis achieved higher response rates and longer PFS than those without (37% vs. 18%, and 5.8 vs. 2.1 months, respectively; P = 0.002). Smoking status, PS, and EGFR mutation/ALK rearrangement were independent predictors of PFS. Our study elucidated nivolumab's efficacy in previously underreported patient populations; i.e., those with poor PS and/or with driver oncogenes. We also found that pneumonitis is not infrequent, and carries key implications for outcomes. These data should be useful for improving the clinical courses of nivolumab-treated patients with NSCLC. Copyright © 2018 Elsevier B.V. All rights reserved.

Prognostic factors of HER2-positive breast cancer patients who develop brain metastasis: a multicenter retrospective analysis.

PubMed

Hayashi, Naoki; Niikura, Naoki; Masuda, Norikazu; Takashima, Seiki; Nakamura, Rikiya; Watanabe, Ken-ichi; Kanbayashi, Chizuko; Ishida, Mayumi; Hozumi, Yasuo; Tsuneizumi, Michiko; Kondo, Naoto; Naito, Yoichi; Honda, Yayoi; Matsui, Akira; Fujisawa, Tomomi; Oshitanai, Risa; Yasojima, Hiroyuki; Yamauchi, Hideko; Saji, Shigehira; Iwata, Hiroji

2015-01-01

The clinical course and prognostic factors of HER2-positive breast cancer patients with brain metastases are not well known because of the relatively small population. The aim of this study was to determine prognostic factors associated with HER2-positive patients who develop brain metastases. This retrospective study assessed the largest dataset to date of 432 HER2-positive patients who were diagnosed with brain metastases from 24 institutions of the Japan Clinical Oncology Group, Breast Cancer Study Group. The median age of the 432 patients was 54 years (range, 20-86 years). Of the patients, 162 patients (37.5 %) had ER-positive/HER2-positive (ER+HER2+) breast cancer, and 270 (62.5 %) had ER-negative/HER2-positive (ER-HER2+) breast cancer. The median brain metastasis-free survival period from primary breast cancer was 33.5 months in both groups. The median survival after developing brain metastasis was 16.5 and 11.5 months in the ER+HER2+ and ER-HER2+ groups, respectively, (p = 0.117). Patients with >3 brain metastases had significantly shorter overall survival in both ER+HER2+ (p < 0.001) and ER-HER2+ (p = 0.018) groups. Treatment with trastuzumab before developing brain metastases was not associated with survival duration after developing brain metastases (p = 0.571). However, patients treated with both trastuzumab and lapatinib after developing metastasis had significantly longer survival than patients treated with trastuzumab alone, lapatinib alone, or no HER2-targeting agent (p < 0.001). For HER2-positive patients with brain metastases, regardless of the use of trastuzumab before developing brain metastasis, treatment with both trastuzumab and lapatinib might improve survival.

Histoplasmosis Complicating Tumor Necrosis Factor–α Blocker Therapy: A Retrospective Analysis of 98 Cases

PubMed Central

Vergidis, Paschalis; Avery, Robin K.; Wheat, L. Joseph; Dotson, Jennifer L.; Assi, Maha A.; Antoun, Smyrna A.; Hamoud, Kassem A.; Burdette, Steven D.; Freifeld, Alison G.; McKinsey, David S.; Money, Mary E.; Myint, Thein; Andes, David R.; Hoey, Cynthia A.; Kaul, Daniel A.; Dickter, Jana K.; Liebers, David E.; Miller, Rachel A.; Muth, William E.; Prakash, Vidhya; Steiner, Frederick T.; Walker, Randall C.; Hage, Chadi A.

2015-01-01

Background. Histoplasmosis may complicate tumor necrosis factor (TNF)–α blocker therapy. Published case series provide limited guidance on disease management. We sought to determine the need for long-term antifungal therapy and the safety of resuming TNF-α blocker therapy after successful treatment of histoplasmosis. Methods. We conducted a multicenter retrospective review of 98 patients diagnosed with histoplasmosis between January 2000 and June 2011. Multivariate logistic regression was used to evaluate risk factors for severe disease. Results. The most commonly used biologic agent was infliximab (67.3%). Concomitant corticosteroid use (odds ratio [OR], 3.94 [95% confidence interval {CI}, 1.06–14.60]) and higher urine Histoplasma antigen levels (OR, 1.14 [95% CI, 1.03–1.25]) were found to be independent predictors of severe disease. Forty-six (47.4%) patients were initially treated with an amphotericin B formulation for a median duration of 2 weeks. Azole treatment was given for a median of 12 months. TNF-α blocker therapy was initially discontinued in 95 of 98 (96.9%) patients and later resumed in 25 of 74 (33.8%) patients at a median of 12 months (range, 1–69 months). The recurrence rate was 3.2% at a median follow-up period of 32 months. Of the 3 patients with recurrence, 2 had restarted TNF-α blocker therapy, 1 of whom died. Mortality rate was 3.2%. Conclusions. In this study, disease outcomes were generally favorable. Discontinuation of antifungal treatment after clinical response and an appropriate duration of therapy, probably at least 12 months, appears safe if pharmacologic immunosuppression has been held. Resumption of TNF-α blocker therapy also appears safe, assuming that the initial antifungal therapy was administered for 12 months. PMID:25870331

Surgery for chronic pancreatitis decreases the risk for pancreatic cancer: a multicenter retrospective analysis.

PubMed

Ueda, Junji; Tanaka, Masao; Ohtsuka, Takao; Tokunaga, Shoji; Shimosegawa, Tooru

2013-03-01

Chronic pancreatitis is suggested to be one of the risk factors for the development of pancreatic cancer. The aim of this study was to confirm the high incidence of pancreatic cancer in patients with chronic pancreatitis in Japan and to determine the factors associated with the risk for pancreatic cancer in patients with chronic pancreatitis. The working group of the Research Committee of Intractable Disease supported by the Ministry of Health, Labour and Welfare of Japan carried out a nationwide survey to investigate the relationship between chronic pancreatitis and pancreatic cancer. This retrospective study included patients diagnosed with chronic pancreatitis who had had at least 2 years of follow-up. They were contacted through 22 Japanese referral centers experienced in the management of chronic pancreatitis. The standardized incidence ratio (95 CI) of pancreatic cancer was 11.8 (7.1-18.4). The incidence of pancreatic cancer was significantly lower in patients who had received surgery for chronic pancreatitis than in those who had not undergone surgery (hazard ratio estimated by Cox regression 0.11; 95% CI, 0.0014-0.80; P = .03). Patients who continued to drink alcohol after diagnosis of chronic pancreatitis showed a significantly higher incidence of pancreatic cancer than those who stopped drinking after diagnosis of chronic pancreatitis (hazard ratio, 5.07; 95% CI, 1.13-22.73; P = .03). This study confirmed that chronic pancreatitis is an important risk factor for the development of pancreatic cancer in Japan. Patients who underwent surgery for the treatment of chronic pancreatitis had significantly lower incidences of pancreatic cancer. Surgery for chronic pancreatitis may inhibit the development of pancreatic cancer in patients with chronic pancreatitis. Copyright © 2013 Mosby, Inc. All rights reserved.

Natural course and prognosis of anaplastic gangliogliomas: a multicenter retrospective study of 43 cases from the French Brain Tumor Database

PubMed Central

Terrier, Louis-Marie; Bauchet, Luc; Rigau, Valérie; Amelot, Aymeric; Zouaoui, Sonia; Filipiak, Isabelle; Caille, Agnès; Almairac, Fabien; Aubriot-Lorton, Marie-Hélène; Bergemer-Fouquet, Anne-Marie; Bord, Eric; Cornu, Philippe; Czorny, Alain; Dam Hieu, Phong; Debono, Bertrand; Delisle, Marie-Bernadette; Emery, Evelyne; Farah, Walid; Gauchotte, Guillaume; Godfraind, Catherine; Guyotat, Jacques; Irthum, Bernard; Janot, Kevin; Le Reste, Pierre-Jean; Liguoro, Dominique; Loiseau, Hugues; Lot, Guillaume; Lubrano, Vincent; Mandonnet, Emmanuel; Menei, Philippe; Metellus, Philippe; Milin, Serge; Muckenstrum, Bertrand; Roche, Pierre-Hugues; Rousseau, Audrey; Uro-Coste, Emmanuelle; Vital, Anne; Voirin, Jimmy; Wager, Michel; Zanello, Marc; François, Patrick; Velut, Stéphane; Varlet, Pascale; Figarella-Branger, Dominique; Pallud, Johan

2017-01-01

Abstract Background. Anaplastic gangliogliomas (GGGs) are rare tumors whose natural history is poorly documented. We aimed to define their clinical and imaging features and to identify prognostic factors. Methods. Consecutive cases of anaplastic GGGs in adults prospectively entered into the French Brain Tumor Database between March 2004 and April 2014 were screened. After diagnosis was confirmed by pathological review, clinical, imaging, therapeutic, and outcome data were collected retrospectively. Results. Forty-three patients with anaplastic GGG (median age, 49.4 y) from 18 centers were included. Presenting symptoms were neurological deficit (37.2%), epileptic seizure (37.2%), or increased intracranial pressure (25.6%). Typical imaging findings were unifocal location (94.7%), contrast enhancement (88.1%), central necrosis (43.2%), and mass effect (47.6%). Therapeutic strategy included surgical resection (95.3%), adjuvant radiochemotherapy (48.8%), or radiotherapy alone (27.9%). Median progression-free survival (PFS) and overall survival (OS) were 8.0 and 24.7 months, respectively. Three- and 5-year tumor recurrence rates were 69% and 100%, respectively. The 5-year survival rate was 24.9%. Considering unadjusted significant prognostic factors, tumor midline crossing and frontal location were associated with shorter OS. Temporal and parietal locations were associated with longer and shorter PFS, respectively. None of these factors remained statistically significant in multivariate analysis. Conclusions. We report a large series providing clinical, imaging, therapeutic, and prognostic features of adult patients treated for an intracerebral anaplastic GGG. Our results show that pathological diagnosis is difficult, that survivals are only slightly better than for glioblastomas, and that complete surgical resection followed with adjuvant chemoradiotherapy offers longer survival. PMID:28453747

Pretreatment tables predicting pathologic stage of locally advanced prostate cancer.

PubMed

Joniau, Steven; Spahn, Martin; Briganti, Alberto; Gandaglia, Giorgio; Tombal, Bertrand; Tosco, Lorenzo; Marchioro, Giansilvio; Hsu, Chao-Yu; Walz, Jochen; Kneitz, Burkhard; Bader, Pia; Frohneberg, Detlef; Tizzani, Alessandro; Graefen, Markus; van Cangh, Paul; Karnes, R Jeffrey; Montorsi, Francesco; van Poppel, Hein; Gontero, Paolo

2015-02-01

Pretreatment tables for the prediction of pathologic stage have been published and validated for localized prostate cancer (PCa). No such tables are available for locally advanced (cT3a) PCa. To construct tables predicting pathologic outcome after radical prostatectomy (RP) for patients with cT3a PCa with the aim to help guide treatment decisions in clinical practice. This was a multicenter retrospective cohort study including 759 consecutive patients with cT3a PCa treated with RP between 1987 and 2010. Retropubic RP and pelvic lymphadenectomy. Patients were divided into pretreatment prostate-specific antigen (PSA) and biopsy Gleason score (GS) subgroups. These parameters were used to construct tables predicting pathologic outcome and the presence of positive lymph nodes (LNs) after RP for cT3a PCa using ordinal logistic regression. In the model predicting pathologic outcome, the main effects of biopsy GS and pretreatment PSA were significant. A higher GS and/or higher PSA level was associated with a more unfavorable pathologic outcome. The validation procedure, using a repeated split-sample method, showed good predictive ability. Regression analysis also showed an increasing probability of positive LNs with increasing PSA levels and/or higher GS. Limitations of the study are the retrospective design and the long study period. These novel tables predict pathologic stage after RP for patients with cT3a PCa based on pretreatment PSA level and biopsy GS. They can be used to guide decision making in men with locally advanced PCa. Our study might provide physicians with a useful tool to predict pathologic stage in locally advanced prostate cancer that might help select patients who may need multimodal treatment. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

How accurate are orthopedic surgeons in diagnosing periprosthetic joint infection after total knee arthroplasty?: A multicenter study.

PubMed

Koh, In Jun; Cho, Woo-Shin; Choi, Nam Yong; Parvizi, Javad; Kim, Tae Kyun

2015-06-01

The lack of standardized diagnostic criteria for periprosthetic joint infection (PJI) poses a challenge to accurate diagnosis of PJI. Recently, the Musculoskeletal Infection Society (MSIS) proposed diagnostic criteria for PJI. However, it is not known how well these proposed criteria accommodate real clinical scenarios. We determined what proportion of patients satisfied the MSIS criteria, and if MSIS criteria were not met, what other rationales were used to diagnose PJI. We retrospectively reviewed the records of 303 patients who underwent two-stage exchange arthroplasty for treatment of PJI of the knee at 17 institutions. The rationale for making the diagnosis of PJI was also recorded, if the case did not meet the MSIS criteria. In addition, detailed information about isolated microorganisms were gathered. Among the 303 patients, 198 met the diagnostic criteria proposed by MSIS. Among the 105 patients who did not meet the MSIS criteria, 88% met two or three minor criteria; however joint fluid analysis or histologic analysis was not performed in 85% of these 105 patients. The most common rationale for the diagnosis of PJI was the presence of abnormal physical findings. Microorganisms were identified in only 52% of all patients; the most common organism was coagulase-negative Staphylococcus. The diagnosis of PJI was based on clinical suspicion in approximately one-third of cases. In this series, joint aspiration or histological analysis was not performed in a large number of patients. Thus, surgeons should perform joint fluid and histologic analysis to assure the accuracy of PJI diagnosis. Copyright © 2015 Elsevier B.V. All rights reserved.

Next-generation sequencing diagnostics of bacteremia in sepsis (Next GeneSiS-Trial): Study protocol of a prospective, observational, noninterventional, multicenter, clinical trial.

PubMed

Brenner, Thorsten; Decker, Sebastian O; Grumaz, Silke; Stevens, Philip; Bruckner, Thomas; Schmoch, Thomas; Pletz, Mathias W; Bracht, Hendrik; Hofer, Stefan; Marx, Gernot; Weigand, Markus A; Sohn, Kai

2018-02-01

Sepsis remains a major challenge, even in modern intensive care medicine. The identification of the causative pathogen is crucial for an early optimization of the antimicrobial treatment regime. In this context, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care, although they are associated with relevant limitations. Accordingly, culture-independent molecular diagnostic procedures might be of help for the identification of the causative pathogen in infected patients. The concept of an unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) has recently been identified to be a promising diagnostic platform for critically ill patients suffering from bloodstream infections. Although this new approach might be more sensitive and specific than culture-based state-of-the-art technologies, additional clinical trials are needed to exactly define the performance as well as clinical value of a NGS-based approach. Next GeneSiS is a prospective, observational, noninterventional, multicenter study to assess the diagnostic performance of a NGS-based approach for the detection of relevant infecting organisms in patients with suspected or proven sepsis [according to recent sepsis definitions (sepsis-3)] by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard (culture-based) microbiological diagnostics. The clinical value of this NGS-based approach will be estimated by a panel of independent clinical specialists, retrospectively identifying potential changes in patients' management based on NGS results. Further subgroup analyses will focus on the clinical value especially for patients suffering from a failure of empiric treatment within the first 3 days after onset [as assessed by death of the patient or lack of improvement of the patient's clinical condition (in terms of an inadequate decrease of SOFA-score) or persistent high procalcitonin levels]. This prospective, observational, noninterventional, multicenter study for the first time investigates the performance as well as the clinical value of a NGS-based approach for the detection of bacteremia in patients with sepsis and may therefore be a pivotal step toward the clinical use of NGS in this indication. DRKS-ID: DRKS00011911 (registered October 9, 2017) https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011911; ClinicalTrials.gov Identifier: NCT03356249 (registered November 29, 2017) https://clinicaltrials.gov/ct2/show/NCT03356249.

Test-retest and between-site reliability in a multicenter fMRI study.

PubMed

Friedman, Lee; Stern, Hal; Brown, Gregory G; Mathalon, Daniel H; Turner, Jessica; Glover, Gary H; Gollub, Randy L; Lauriello, John; Lim, Kelvin O; Cannon, Tyrone; Greve, Douglas N; Bockholt, Henry Jeremy; Belger, Aysenil; Mueller, Bryon; Doty, Michael J; He, Jianchun; Wells, William; Smyth, Padhraic; Pieper, Steve; Kim, Seyoung; Kubicki, Marek; Vangel, Mark; Potkin, Steven G

2008-08-01

In the present report, estimates of test-retest and between-site reliability of fMRI assessments were produced in the context of a multicenter fMRI reliability study (FBIRN Phase 1, www.nbirn.net). Five subjects were scanned on 10 MRI scanners on two occasions. The fMRI task was a simple block design sensorimotor task. The impulse response functions to the stimulation block were derived using an FIR-deconvolution analysis with FMRISTAT. Six functionally-derived ROIs covering the visual, auditory and motor cortices, created from a prior analysis, were used. Two dependent variables were compared: percent signal change and contrast-to-noise-ratio. Reliability was assessed with intraclass correlation coefficients derived from a variance components analysis. Test-retest reliability was high, but initially, between-site reliability was low, indicating a strong contribution from site and site-by-subject variance. However, a number of factors that can markedly improve between-site reliability were uncovered, including increasing the size of the ROIs, adjusting for smoothness differences, and inclusion of additional runs. By employing multiple steps, between-site reliability for 3T scanners was increased by 123%. Dropping one site at a time and assessing reliability can be a useful method of assessing the sensitivity of the results to particular sites. These findings should provide guidance toothers on the best practices for future multicenter studies.

Collateral non cardiac findings in clinical routine CT coronary angiography: results from a multi-center registry.

PubMed

La Grutta, Ludovico; Malagò, Roberto; Maffei, Erica; Barbiani, Camilla; Pezzato, Andrea; Martini, Chiara; Arcadi, Teresa; Clemente, Alberto; Mollet, Nico R; Zuccarelli, Alessandra; Krestin, Gabriel P; Lagalla, Roberto; Pozzi Mucelli, Roberto; Cademartiri, Filippo; Midiri, Massimo

2015-12-01

The aim of the study was to evaluate the prevalence of collateral findings detected in computed tomography coronary angiography (CTCA) in a multi-center registry. We performed a retrospective review of 4303 patients (2719 males, mean age 60.3 ± 10.2 years) undergoing 64-slice CTCA for suspected or known coronary artery disease (CAD) at various academic institutions between 01/2006 and 09/2010. Collateral findings were recorded and scored as: non-significant (no signs of relevant pathology, not necessary to be reported), significant (clear signs of pathology, mandatory to be reported), or major (remarkable pathology, mandatory to be reported and further investigated). We detected 6886 non-cardiac findings (1.6 non cardiac finding per patient). Considering all centers, only 865/4303 (20.1 %) patients were completely without any additional finding. Overall, 2095 (30.4 %) non-significant, 4486 (65.2 %) significant, and 305 (4.4 %) major findings were detected. Among major findings, primary lung cancer was reported in 21 cases. In every center, most prevalent significant findings were mediastinal lymph nodes >1 cm. In 256 patients, collateral findings were clinically more relevant than coexisting CAD and justified the symptoms of patients. The prevalence of significant and major collateral findings in CTCA is high. Radiologists should carefully evaluate the entire scan volume in each patient.

Prevalence and Outcomes in Patients Undergoing Reintubation After Anterior Cervical Spine Surgery: Results From the AOSpine North America Multicenter Study on 8887 Patients

PubMed Central

Nagoshi, Narihito; Nakashima, Hiroaki; Tetreault, Lindsay; Gum, Jeffrey L.; Smith, Zachary A.; Hsu, Wellington K.; Tannoury, Chadi A.; Tannoury, Tony; Traynelis, Vincent C.; Arnold, Paul M.; Mroz, Thomas E.; Gokaslan, Ziya L.; Bydon, Mohamad; De Giacomo, Anthony F.; Jobse, Bruce C.; Massicotte, Eric M.; Riew, K. Daniel

2017-01-01

Study Design: A multicenter, retrospective cohort study. Objective: To evaluate clinical outcomes in patients with reintubation after anterior cervical spine surgery. Methods: A total of 8887 patients undergoing anterior cervical spine surgery were enrolled in the AOSpine North America Rare Complications of Cervical Spine Surgery study. Patients with or without complications after surgery were included. Demographic and surgical information were collected for patients with reintubation. Patients were evaluated using a variety of assessment tools, including the modified Japanese Orthopedic Association scale, Nurick score, Neck Disability Index, and Short Form-36 Health Survey. Results: Nine cases of postoperative reintubation were identified. The total prevalence of this complication was 0.10% and ranged from 0% to 0.59% across participating institutions. The time to development of airway symptoms after surgery was within 24 hours in 6 patients and between 5 and 7 days in 3 patients. Although 8 patients recovered, 1 patient died. At final follow-up, patients with reintubation did not exhibit significant and meaningful improvements in pain, functional status, or quality of life. Conclusions: Although the prevalence of reintubation was very low, this complication was associated with adverse clinical outcomes. Clinicians should identify their high-risk patients and carefully observe them for up to 2 weeks after surgery. PMID:28451501

The Impact of the Hospital Volume on the Performance of Residents on the General Medicine In-Training Examination: A Multicenter Study in Japan.

PubMed

Mizuno, Atsushi; Tsugawa, Yusuke; Shimizu, Taro; Nishizaki, Yuji; Okubo, Tomoya; Tanoue, Yusuke; Konishi, Ryota; Shiojiri, Toshiaki; Tokuda, Yasuharu

2016-01-01

Objective Although several studies have been conducted worldwide on factors that might improve residents' knowledge, the relationship between the hospital volume and the internal medicine residents' knowledge has not been fully understood. We conducted a cross-sectional study to compare the relationships of the hospital volume and hospital resources with the residents' knowledge assessed by the In-training Examination. Methods We conducted a retrospective survey and a clinical knowledge evaluation of postgraduate year 1 and 2 (PGY-1 and -2) resident physicians in Japan by using the General Medicine In-training Examination (GM-ITE) in 2014. We compared the ITE score and the hospital volume. Results A total of 2,015 participants (70.6% men; age, 27.3±2.9 years old) from 208 hospitals were retrospectively analyzed. Generalized estimating equations were used, and the results revealed that an increasing number of hospitalizations, decreasing staff number, decreasing age and PGY-2 were significantly associated with higher GM-ITE scores. Conclusion The hospital volume, such as the number of hospitalizations, is thus considered to have a positive impact on the GM-ITE scores.

Comparison of resource utilization of pulmonary vein isolation: cryoablation versus RF ablation with three-dimensional mapping in the Value PVI Study.

PubMed

DeVille, J Brian; Svinarich, J Thomas; Dan, Dan; Wickliffe, Andrew; Kantipudi, Charan; Lim, Hae W; Plummer, Lisa; Baker, James; Kowalski, Marcin; Baydoun, Hassan; Jenkins, Mark; Chang-Sing, Peter

2014-06-01

Point-to-point focal radiofrequency (RF) catheter ablation for aberrant pulmonary vein triggers that manifest into atrial fibrillation (AF) is the traditional method for treating symptomatic drug-resistant paroxysmal AF (PAF) when an ablation procedure is warranted. More recently, pulmonary vein isolation (PVI) using the cryoballoon has been demonstrated to be safe and effective (STOP AF clinical trial). Currently, two small studies have reviewed the procedural efficiency when comparing cryoballoon to focal RF catheter ablation procedures; however, no multicenter study has yet reported on this comparison of the two types of ablation catheters. A multicenter retrospective chart extraction and evaluation was conducted at seven geographically mixed cardiac care centers. The study examined procedural variables during ablation for PVI in PAF patients. In several procedural measurements, the two modalities were comparable in efficiencies, including: acute PVI >96%; length of hospital stay at approximately 27 hours; and about 30% usage of adenosine after procedural testing. However, when compared to RF catheters, the cryoballoon procedure demonstrated a 13% reduction in laboratory occupancy time (247 min vs 283 min), a 13% reduction in procedure time (174 min vs 200 min), and a 21% reduction in fluoroscopy time (33 min vs 42 min). Additionally, when comparing the material usage of both cryoballoon and RF catheters, the cryoballoon used more radiopaque contrast agent (78 cc vs 29 cc) while using less intraprocedural saline (1234 cc vs 2386 cc), intracardiac echocardiography (88% vs 99%), three-dimensional electroanatomic mapping (30% vs 87%), and fewer transseptal punctures (1.5 vs 1.9). This study is the first United States multicenter examination to report the procedural comparisons between the cryoballoon and focal RF catheters when used for the treatment of PAF patients. In this hospital chart review study, potential advantages were found when operating the cryoballoon with regard to hospital resource allocation. There was no statistical difference between cryoballoon and RF catheters for acute PVI success during the ablation procedure.

Traumatic colon injury in damage control laparotomy-A multicenter trial: Is it safe to do a delayed anastomosis?

PubMed

Tatebe, Leah Carey; Jennings, Andrew; Tatebe, Ken; Handy, Alexandra; Prajapati, Purvi; Smith, Michael; Do, Tai; Ogola, Gerald O; Gandhi, Rajesh R; Duane, Therese M; Luk, Stephen; Petrey, Laura Bruce

2017-04-01

Delayed colonic anastomosis after damage control laparotomy (DCL) is an alternative to colostomies during a single laparotomy (SL) in high-risk patients. However, literature suggests increased colonic leak rates up to 27% with DCL, and various reported risk factors. We evaluated our regional experience to determine if delayed colonic anastomosis was associated with worse outcomes. A multicenter retrospective cohort study was performed across three Level I trauma centers encompassing traumatic colon injuries from January 2006 through June 2014. Patients with rectal injuries or mortality within 24 hours were excluded. Patient and injury characteristics, complications, and interventions were compared between SL and DCL groups. Regional readmission data were utilized to capture complications within 6 months of index trauma. Of 267 patients, 69% had penetrating injuries, 21% underwent DCL, and the mortality rate was 4.9%. Overall, 176 received primary repair (26 in DCL), 90 had resection and anastomosis (28 in DCL), and 26 had a stoma created (10 end colostomies and 2 loop ileostomies in DCL). Thirty-five of 56 DCL patients had definitive colonic repair subsequent to their index operation. DCL patients were more likely to be hypotensive; require more resuscitation; and suffer acute kidney injury, pneumonia, adult respiratory distress syndrome, and death. Five enteric leaks (1.9%) and three enterocutaneous fistulas (ECF, 1.1%) were identified, proportionately distributed between DCL and SL (p = 1.00, p = 0.51). No difference was seen in intraperitoneal abscesses (p = 0.13) or surgical site infections (SSI, p = 0.70) between cohorts. Among SL patients, pancreas injuries portended an increased risk of intraperitoneal abscesses (p = 0.0002), as did liver injuries in DCL patients (p = 0.06). DCL was not associated with increased enteric leaks, ECF, SSI, or intraperitoneal abscesses despite nearly two-thirds having delayed repair. Despite this being a multicenter study, it is underpowered, and a prospective trial would better demonstrate risks of DCL in colon trauma. Therapeutic study, level IV.

Anti-ribosomal P antibody: a multicenter study in childhood-onset systemic lupus erythematosus patients.

PubMed

Valões, C C M; Molinari, B C; Pitta, A C G; Gormezano, N W S; Farhat, S C L; Kozu, K; Sallum, A M E; Appenzeller, S; Sakamoto, A P; Terreri, M T; Pereira, R M R; Magalhães, C S; Ferreira, J C O A; Barbosa, C M; Gomes, F H; Bonfá, E; Silva, C A

2017-04-01

Objectives Anti-ribosomal P protein (anti-P) autoantibodies are highly specific for systemic lupus erythematosus (SLE). However, the evaluation of this autoantibody in childhood-onset SLE (cSLE) populations has been limited to a few small series, hampering the interpretation of the clinical and laboratorial associations. Therefore, the objective of this multicenter cohort study was to evaluate demographic, clinical/laboratorial features, and disease damage score in cSLE patients with and without the presence of anti-P antibody. Methods This was a retrospective multicenter study performed in 10 pediatric rheumatology services of São Paulo state, Brazil. Anti-P antibodies were measured by ELISA in 228 cSLE patients. Results Anti-P antibodies were observed in 61/228 (27%) cSLE patients. Frequencies of cumulative lymphadenopathy (29% vs. 15%, p = 0.014), acute confusional state (13% vs. 5%, p = 0.041), mood disorder (18% vs. 8%, p = 0.041), autoimmune hemolytic anemia (34% vs. 15%, p = 0.001), as well as presence of anti-Sm (67% vs. 40%, p = 0.001), anti-RNP (39% vs. 21%, p = 0.012) and anti-Ro/SSA antibodies (43% vs. 25%, p = 0.016) were significantly higher in cSLE patients with anti-P antibodies compared to those without these autoantibodies. A multiple regression model revealed that anti-P antibodies were associated with autoimmune hemolytic anemia (odds ratio (OR) = 2.758, 95% confidence interval (CI): 1.304-5.833, p = 0.008) and anti-Sm antibody (OR = 2.719, 95% CI: 1.365-5.418, p = 0.004). The SLICC/ACR damage index was comparable in patients with and without anti-P antibodies ( p = 0.780). Conclusions The novel association of anti-P antibodies and autoimmune hemolytic anemia was evidenced in cSLE patients and further studies are necessary to determine if anti-P titers may vary with this hematological manifestation.

Retrospective data collection of psoriasis treatment with fumaric acid esters in children and adolescents in Germany (KIDS FUTURE study).

PubMed

Reich, Kristian; Hartl, Christoph; Gambichler, Thilo; Zschocke, Ina

2016-01-01

Given that there is no standard systemic treatment for children and adolescents with plaque psoriasis, this non-interventional, multicenter, retrospective study collected data on the efficacy and safety of long-term treatment with fumaric acid esters (FAEs) in this particular patient group. In patients younger than 18 years of age at the start of FAE treatment, data on efficacy and safety was retrospectively collected for at least 36 months. Data from 127 patients (aged 6-17 years) was collected for treatment durations of up to 60 months. Physician's Global Assessment, Psoriasis Area and Severity Index, and Body Surface Area showed marked improvement in the first six months. After 36 months, these parameters had, on average, improved by up to two-thirds of baseline values. Thirty-seven patients experienced at least one adverse event (AE), which was FAE-related in 36 individuals. Three AEs (proteinuria (one case), flushing (two cases)) persisted during the observation period while on treatment. Fifteen AEs led to the discontinuation of therapy; nearly all of these cases were related to gastrointestinal disorders. The KIDS FUTURE study - for the first time - included a larger population of children and adolescents with psoriasis who were treated with FAEs. The data obtained suggests that long-term FAE therapy in this patient group may be effective and safe. The results are currently being verified in an ongoing clinical study. © 2015 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

Characteristics and Outcomes of Second Malignant Neoplasms after Childhood Cancer Treatment: Multi-Center Retrospective Survey.

PubMed

Koh, Kyung-Nam; Yoo, Keon Hee; Im, Ho Joon; Sung, Ki Woong; Koo, Hong Hoe; Kim, Hyo Sun; Han, Jung Woo; Yoon, Jong Hyung; Park, Hyeon Jin; Park, Byung-Kiu; Baek, Hee Jo; Kook, Hoon; Lee, Jun Ah; Lee, Jae Min; Lee, Kwang Chul; Kim, Soon Ki; Park, Meerim; Lee, Young-Ho; Lyu, Chuhl Joo; Seo, Jong Jin

2016-08-01

This retrospective study investigated the clinical characteristics and outcomes of second malignant neoplasms (SMNs) in survivors of childhood cancer from multiple institutions in Korea. A total of 102 patients from 11 institutions who developed SMN after childhood cancer treatment between 1998 and 2011 were retrospectively enrolled. The most common primary malignant neoplasms (PMNs) were central nervous system (CNS) tumors (n = 17), followed by acute lymphoblastic leukemia (n = 16), non-Hodgkin lymphoma (n = 13), and osteosarcoma (n = 12). The most common SMNs were therapy-related myeloid neoplasms (t-MNs; acute myeloid leukemia [AML], 29 cases; myelodysplastic syndrome [MDS], 12 cases), followed by thyroid carcinomas (n = 15) and CNS tumors (n = 10). The median latency period was 4.9 years (range, 0.5-18.5 years). Among 45 patients with solid tumors defined as an SMN, 15 (33%) developed the lesion in a field previously subjected to radiation. The 5-year overall survival (OS) rate of patients with an SMN was 45% with a median follow-up time of 8.6 years. Patients with AML, MDS, and CNS tumors exhibited the poorest outcomes with 5-year OS rates of 18%, 33%, and 32%, respectively, whereas those with second osteosarcoma showed comparable outcomes (64%) to patients with primary counterpart and those with second thyroid carcinoma had a 100% OS rate. Further therapeutic efforts are recommended to improve the survival outcomes in patients with SMNs, especially in cases with t-MNs and CNS tumors.

Multicenter Off-Label Use of Nit-Occlud Coil in Retrograde Closure of Small Patent Ductus Arteriosus.

PubMed

Zanjani, Keyhan Sayadpour; Sobhy, Rodina; El-Kaffas, Rania; El-Sisi, Amal

2017-04-01

We studied the safety and efficacy of closing patent ductus arteriosus by Nit-Occlud coils via retrograde approach. This is a retrospective study of 46 attempts to close ducts by this method in two hospitals in Egypt and Iran. Ductus arteriosus was crossed by left or right Judkins or endhole catheters. The coil was delivered via the same catheter or the provided endhole catheter after exchange. The procedure was successful in 42 out of 46 attempts. Fluoroscopy and procedural times were significantly shorter when the catheter was not exchanged. This method is effective and safe for the closure of small ducts. Crossing the duct and delivering the coil by a left Judkins catheter is the easiest and fastest way to perform this method.

Rivastigmine in moderately severe-to-severe Alzheimer’s disease: Severe Impairment Battery factor analysis

PubMed Central

2013-01-01

Introduction The Severe Impairment Battery (SIB) is validated for assessing cognition in patients with severe dementia. The current analysis aimed to further investigate the cognitive efficacy of rivastigmine capsules, as assessed by SIB factor scores, in patients with moderately severe-to-severe Alzheimer’s disease (AD). Methods This was a retrospective analysis of a 26-week, multicenter, randomized, double-blind, placebo-controlled study of oral rivastigmine conducted in Spain. Previously reported outcome measures included the full SIB. Current analyses examined calculated scores and effect sizes for the change from baseline at Week 26 on: newly defined SIB subscales (derived by a factor analysis of the 40 SIB items, using the PROC FACTOR function (SAS)); previously defined memory, language and praxis subscales (derived by previous analysis of the nine SIB domains); and the individual SIB items. Treatment differences were assessed. Results SIB data were provided by 104 rivastigmine-treated patients and 106 patients receiving placebo (Intent-To-Treat Last Observation Carried Forward population). Significantly less decline was observed on the previously defined memory and language subscales, and the newly defined working memory/memory subscale in rivastigmine-treated patients (all P < 0.05 versus placebo). Calculation of effect sizes demonstrated numerically greater efficacy of rivastigmine versus placebo on each of the subscales, and a broad range of SIB items; greatest effect sizes were observed on SIB items assessing the current month (effect size = 0.30) and digit span series (effect size = 0.33). Conclusions These data suggest the observed efficacy of rivastigmine in moderately severe-to-severe AD is likely a cumulative effect across a range of tasks. Rivastigmine demonstrates broad cognitive efficacy in this patient population. PMID:24351447

Epidemiology, surgical management and early postoperative outcome in a cohort of gastric cancer patients of a tertiary referral center in relation to multi-center quality assurance studies.

PubMed

Garlipp, Benjamin; Schwalenberg, Jens; Adolf, Daniela; Lippert, Hans; Meyer, Frank

2011-03-01

The aim of the study was to analyze epidemiologic parameters, treatment-related data and prognostic factors in the management of gastric cancer patients of a university surgical center under conditions of routine clinical care before the onset of the era of multimodal therapies. By analyzing our data in relation with multi-center quality assurance trials [German Gastric Cancer Study - GGCS (1992) and East German Gastric Cancer Study - EGGCS (2004)] we aimed at providing an instrument of internal quality control at our institution as well as a base for comparison with future analyses taking into account the implementation of evolving (multimodal) therapies and their influence on treatment results. Retrospective analysis of prospectively gathered data of gastric cancer patients treated at a single institution during a defined 10-year time period with multivariate analysis of risk factors for early postoperative outcome. From 04/01/1993 through 03/31/2003, a total of 328 gastric cancer patients were treated. In comparison with the EGGCS cohort there was a larger proportion of patients with locally advanced and proximally located tumors. 272 patients (82.9%) underwent surgery with curative intent; in 88.4% of these an R0 resection was achieved (EGGCS/GGCS: 82.5%/71.5%). 68.2% of patients underwent preoperative endoluminal ultrasound (EUS) (EGGCS: 27.4%); the proportion of patients undergoing EUS increased over the study period. Diagnostic accuracy of EUS for T stage was 50.6% (EGGCS: 42.6%). 77.2% of operated patients with curative intent underwent gastrectomy (EGGCS/GGCS: 79.8%/71.1%). Anastomotic leaks at the esophagojejunostomy occurred slightly more frequently (8.8%) than in the EGGCS (5.9%) and GGCS (7.2%); however, postoperative morbidity (36.1%) and early postoperative mortality (5.3%) were not increased compared to the multi-center quality assurance study results (EGGCS morbidity, 45%); EGGCS/GGCS mortality, 8%/8.9%). D2 lymphadenectomy was performed in 72.6% of cases (EGGCS: 70.9%). Multivariate analysis revealed splenectomy as an independent risk factor for postoperative morbidity and ASA status 3 or 4 as an independent risk factor for early postoperative mortality. The rate of splenectomies performed during gastric cancer surgery decreased substantially during the study period. Preoperative diagnostics were able to accurately predict resectability in almost 90% of patients which is substantially more than the corresponding results of both the EGGCS and the GGCS. In the future, more wide-spread use of EUS will play an increasing role as stage-dependent differentiation of therapeutic concepts gains acceptance. However, diagnostic accuracy of EUS needs to be improved. Our early postoperative outcome data demonstrate that the quality standard of gastric cancer care established by the EGGCS is being fulfilled at our institution in spite of distinct characteristics placing our patients at higher surgical risk. Besides being a valuable instrument of internal quality control, our study provides a good base for comparison with ongoing analyses on future developments in gastric cancer therapy.

76 FR 66004 - Preliminary Plan for Retrospective Analysis of Existing Rules

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-25

... and 13563 recognize the importance of maintaining a consistent culture of retrospective review and... documents. IV. Elements of the Plan Fostering a Culture of Retrospective Analysis. The Commission intends to strengthen its culture of retrospective analysis by informing all of its employees of the Plan and...

Multicenter Trial of Sentinel Node Biopsy for Breast Cancer Using Both Technetium Sulfur Colloid and Isosulfan Blue Dye

PubMed Central

Tafra, Lorraine; Lannin, Donald R.; Swanson, Melvin S.; Van Eyk, Jason J.; Verbanac, Kathryn M.; Chua, Arlene N.; Ng, Peter C.; Edwards, Maxine S.; Halliday, Bradford E.; Henry, C. Alan; Sommers, Linda M.; Carman, Claire M.; Molin, Melinda R.; Yurko, John E.; Perry, Roger R.; Williams, Robert

2001-01-01

Objective To determine the factors associated with false-negative results on sentinel node biopsy and sentinel node localization (identification rate) in patients with breast cancer enrolled in a multicenter trial using a combination technique of isosulfan blue with technetium sulfur colloid (Tc99). Summary Background Data Sentinel node biopsy is a diagnostic test used to detect breast cancer metastases. To test the reliability of this method, a complete lymph node dissection must be performed to determine the false-negative rate. Single-institution series have reported excellent results, although one multicenter trial reported a false-negative rate as high as 29% using radioisotope alone. A multicenter trial was initiated to test combined use of Tc99 and isosulfan blue. Methods Investigators (both private-practice and academic surgeons) were recruited after attending a course on the technique of sentinel node biopsy. No investigator participated in a learning trial before entering patients. Tc99 and isosulfan blue were injected into the peritumoral region. Results Five hundred twenty-nine patients underwent 535 sentinel node biopsy procedures for an overall identification rate in finding a sentinel node of 87% and a false-negative rate of 13%. The identification rate increased and the false-negative rate decreased to 90% and 4.3%, respectively, after investigators had performed more than 30 cases. Univariate analysis of tumor showed the poorest success rate with older patients and inexperienced surgeons. Multivariate analysis identified both age and experience as independent predictors of failure. However, with older patients, inexperienced surgeons, and patients with five or more metastatic axillary nodes, the false-negative rate was consistently greater. Conclusions This multicenter trial, from both private practice and academic institutions, is an excellent indicator of the general utility of sentinel node biopsy. It establishes the factors that play an important role (patient age, surgical experience, tumor location) and those that are irrelevant (prior surgery, tumor size, Tc99 timing). This widens the applicability of the technique and identifies factors that require further investigation. PMID:11141225

Retrospective multicenter matched case-control study on the risk factors for narcolepsy with special focus on vaccinations (including pandemic influenza vaccination) and infections in Germany.

PubMed

Oberle, Doris; Pavel, Jutta; Mayer, Geert; Geisler, Peter; Keller-Stanislawski, Brigitte

2017-06-01

Studies associate pandemic influenza vaccination with narcolepsy. In Germany, a retrospective, multicenter, matched case-control study was performed to identify risk factors for narcolepsy, particularly regarding vaccinations (seasonal and pandemic influenza vaccination) and infections (seasonal and pandemic influenza) and to quantify the detected risks. Patients with excessive daytime sleepiness who had been referred to a sleep center between April 2009 and December 2012 for multiple sleep latency test (MSLT) were eligible. Case report forms were validated according to the criteria for narcolepsy defined by the Brighton Collaboration (BC). Confirmed cases of narcolepsy (BC level of diagnostic certainty 1-4a) were matched with population-based controls by year of birth, gender, and place of residence. A second control group was established including patients in whom narcolepsy was definitely excluded (test-negative controls). A total of 103 validated cases of narcolepsy were matched with 264 population-based controls. The second control group included 29 test-negative controls. A significantly increased odd ratio (OR) to develop narcolepsy (crude OR [cOR] = 3.9, 95% confidence interval [CI] = 1.8-8.5; adjusted OR [aOR] = 4.5, 95% CI = 2.0-9.9) was detected in individuals immunized with pandemic influenza A/H1N1/v vaccine prior to symptoms onset as compared to nonvaccinated individuals. Using test-negative controls, in individuals immunized with pandemic influenza A/H1N1/v vaccine prior to symptoms onset, a nonsignificantly increased OR of narcolepsy was detected when compared to nonvaccinated individuals (whole study population, BC levels 1-4a: cOR = 1.9, 95% CI = 0.5-6.9; aOR = 1.8, 95% CI = 0.3-10.1). The findings of this study support an increased risk for narcolepsy after immunization with pandemic influenza A/H1N1/v vaccine. Copyright © 2017 Elsevier B.V. All rights reserved.

Sex-Dependent Differences in Preoperative, Radiographic, and Intraoperative Characteristics of Patients Undergoing Hip Arthroscopy: Results From the Multicenter Arthroscopic Study of the Hip Group.

PubMed

Salvo, John P; Nho, Shane J; Wolff, Andrew B; Christoforetti, John J; Van Thiel, Geoffrey S; Ellis, Thomas J; Matsuda, Dean K; Kivlan, Benjamin R; Chaudhry, Zaira S; Carreira, Dominic S

2018-03-01

To compare preoperative, radiographic, and intraoperative findings between male and female patients undergoing hip arthroscopy. We performed a retrospective review of a multicenter registry of patients undergoing hip arthroscopy between January 2014 and January 2017. Perioperative data from patients who consented to undergo surgery and completed preoperative patient-reported outcome questionnaires were analyzed to determine the effect of sex on preoperative symptoms, patient-reported outcomes, radiographic measures, and surgical procedures. A total of 1,437 patients (902 female and 535 male patients) with a mean age of 34 years were enrolled in the study. Female patients reported greater pain preoperatively on a visual analog scale (55.42 vs 50.40, P = .001) and deficits in functional abilities as per the modified Harris Hip Score (53.40 vs 57.83, P < .001) and International Hip Outcome Tool 12 (31.21 vs 38.51, P = .001) than male patients. There was a significant difference in the alpha angle (67.6° in male patients vs 59.5° in female patients, P < .001) corresponding with a higher prevalence of cam deformity in male patients (94.6% vs 84.5%, P < .001). Male patients had less range of motion in flexion (-5.67°, P < .001), internal rotation (-8.23°, P < .001), and external rotation (-4.52°, P < .001) than female patients. Acetabular chondroplasty was performed in 58% of male patients versus 40.2% of female patients (P < .001). Acetabuloplasty was performed in 59.1% of male patients versus 43.9% of female patients (P < .001). Male and female patients undergoing hip arthroscopy differ statistically in terms of preoperative hip function, hip morphology, and self-reported functional deficits, as well as the prevalence of surgical procedures. However, they do not differ significantly in terms of symptom localization, duration, or onset. The observed differences in preoperative functional scores between sexes, although statistically significant, may not represent clinically meaningful differences. Level III, retrospective cross-sectional study. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Retrospective, Multicenter Comparison of the Clinical Presentation of Patients Presenting With Diplopia From Giant Cell Arteritis vs Other Causes.

PubMed

Ross, Ahmara G; Jivraj, Imran; Rodriguez, Geoffrey; Pistilli, Maxwell; Chen, John J; Sergott, Robert C; Moster, Mark; Sheldon, Claire A; Liu, Grant T; Foroozan, Rod; Ko, Melissa W; Francis, Courtney E; Williams, Zoë R; Lee, Andrew G; McClelland, Collin M; Shindler, Kenneth S; Yalamanchili, Sushma; Osborne, Benjamin; Hedges, Thomas R; Van Stavern, Gregory P; Puckett, Ernest; Rigi, Mohammed; García-Basterra, Ignacia; Tamhankar, Madhura A

2018-04-24

Although giant cell arteritis (GCA) is a well-known cause of transient and permanent vision loss, diplopia as a presenting symptom of this condition is uncommon. We compared symptoms and signs of patients presenting with diplopia from GCA to those from other causes. This was a multicenter, retrospective study comparing the clinical characteristics of patients presenting with diplopia from GCA with age-matched controls. Demographic information, review of symptoms, ophthalmic examination, and laboratory data of biopsy-proven patients with GCA were compared with those of age-matched controls presenting with diplopia. A total of 27 patients presented with diplopia from GCA, 19 with constant diplopia, and 8 with transient diplopia. All patients with constant diplopia from GCA were matched with 67 control subjects who had diplopia from other etiologies. Patients with GCA were more likely to describe other accompanying visual symptoms (58% vs 25%, P = 0.008), a greater number of systemic GCA symptoms (3.5, GCA vs 0.6, controls, P < 0.001) such as headache (94% [17/18] vs 39% [23/67]; P < 0.001), jaw claudication (80% [12/15] vs 0% [0/36]; P < 0.001), and scalp tenderness (44% [7/16] vs 7% [3/43]; P < 0.001). Ocular ischemic lesions (26% vs 1%, P < 0.001) were also common in patients with diplopia from GCA. Inflammatory markers were elevated significantly in patients with GCA vs controls (erythrocyte sedimentation rate: 91% [10/11] vs 12% [3/25], P < 0.001; C-reactive protein: 89% [8/9] vs 11% [2/19], P < 0.001). GCA is a rare but serious cause of diplopia among older adults and must be differentiated from other more common benign etiologies. Our study suggests that most patients with diplopia from GCA have concerning systemic symptoms and/or elevated inflammatory markers that should trigger further work-up. Moreover, careful ophthalmoscopic examination should be performed to look for presence of ocular ischemic lesions in older patients presenting with acute diplopia.

Risk factors for acute kidney injury (AKI) in infants with melamine-associated urolithiasis and follow-up: a multi-center retrospective analysis.

PubMed

He, Qiqi; Yue, Zhongjin; Tang, XiaoShuang; Chang, Hong; Wang, Wei; Shi, Wei; Wang, Zhiping; Shang, Panfeng

2014-10-01

Abstract An epidemic of urinary tract stones was noted among infants in China, 2008. This event was believed to be associated with consumption melamine-contaminated powdered formula. The patients with symptoms and clinical manifests had already been analyzed in our previous studies. In this study, our aim is to investigate the risk factors of melamine-associated acute kidney injury (AKI) and the potential relationship toward children growth in our five years follow-up. A total of 619 infants with melamine-associated urolithiasis were admitted into 20 different hospitals in the Gansu province, China. All clinical data were divided into AKI and control groups according to the occurrence of AKI. Univariate and multivariate analyses were performed with a logistic regression model to assess the independent risk factors of AKI. Logistic regression analysis revealed that the odds ratio (OR) of AKI was 19.62 in the group of infants who consumed Sanlu® milk powdered infant milk formula. A higher prevalence of AKI was observed in infants age of 6-11 months (OR: 9.59, p < 0.01) and 12-17 months (OR: 5.06, p < 0.01). Multivariate analysis also indicated that any one symptoms of upper respiratory tract infection (URTI), diarrhea, dehydration and fever (OR: 4.29, p < 0.01) were independent risk factors of AKI. Therefore, this study demonstrated that high melamine infant formula (Sanlu® milk powdered infant formula), age (6-17 months) and symptoms of URTI, diarrhea, dehydration or fever were risk factors of AKI in infants with melamine-associated urolithiasis.

The Impact of Renin-Angiotensin System Blockade on Renal Outcomes and Mortality in Pre-Dialysis Patients with Advanced Chronic Kidney Disease.

PubMed

Oh, Yun Jung; Kim, Sun Moon; Shin, Byung Chul; Kim, Hyun Lee; Chung, Jong Hoon; Kim, Ae Jin; Ro, Han; Chang, Jae Hyun; Lee, Hyun Hee; Chung, Wookyung; Lee, Chungsik; Jung, Ji Yong

2017-01-01

Renin-angiotensin-system (RAS) blockade is thought to slow renal progression in patients with chronic kidney disease (CKD). However, it remains uncertain if the habitual use of RAS inhibitors affects renal progression and outcomes in pre-dialysis patients with advanced CKD. In this multicenter retrospective cohort study, we identified 2,076 pre-dialysis patients with advanced CKD (stage 4 or 5) from a total of 33,722 CKD patients. RAS blockade users were paired with non-users for analyses using inverse probability of treatment-weighted (IPTW) and propensity score (PS) matching. The outcomes were renal death, all-cause mortality, hospitalization for hyperkalemia, and interactive factors as composite outcomes. RAS blockade users showed an increased risk of renal death in PS-matched analysis (hazard ratio [HR], 1.381; 95% CI, 1.071-1.781; P = 0.013), which was in agreement with the results of IPTW analysis (HR, 1.298; 95% CI, 1.123-1.500; P < 0.001). The risk of composite outcomes was higher in RAS blockade users in IPTW (HR, 1.154; 95% CI, 1.016-1.310; P = 0.027), but was marginal significance in PS matched analysis (HR, 1.243; 95% CI, 0.996-1.550; P = 0.054). The habitual use of RAS blockades in pre-dialysis patients with advanced CKD may have a detrimental effect on renal outcome without improving all-cause mortality. Further studies are warranted to determine whether withholding RAS blockade may lead to better outcomes in these patients.

Location in the right hemi-colon is an independent risk factor for delayed post-polypectomy hemorrhage: a multi-center case-control study.

PubMed

Buddingh, K Tim; Herngreen, Thomas; Haringsma, Jelle; van der Zwet, Wil C; Vleggaar, Frank P; Breumelhof, Ronald; Ter Borg, Frank

2011-06-01

Delayed hemorrhage is an infrequent, but serious complication of colonoscopic polypectomy. Large size is the only polyp-related factor that has been unequivocally proven to increase the risk of delayed bleeding. It has been suggested that location in the right hemi-colon is also a risk factor. The objective of this study was to determine whether polyp location is an independent risk factor for delayed post-polypectomy hemorrhage. A retrospective case-control study was conducted in two university hospitals and two community hospitals. Thirty-nine cases and 117 controls were identified. In multivariate analysis, size and location were found to be independent polyp-related risk factors for delayed type hemorrhage. The risk increased by 13% for every 1 mm increase in polyp diameter (odds ratio (OR) 1.13, 95% confidence interval (CI) 1.05-1.20, P<0.001). Polyps located in the right hemi-colon had an OR of 4.67 (1.88-11.61, P=0.001) for delayed hemorrhage. Polyps in the cecum seemed to be especially at high risk in univariate analysis (OR 13.82, 95% CI 2.66-71.73), but this could not be assessed in multivariate analysis as the number of cases was too small. Polyp type (sessile or pedunculated) was not a risk factor. Polyp location in the right hemi-colon seems to be an independent and substantial risk factor for delayed post-polypectomy hemorrhage. A low threshold for preventive hemostatic measures is advised when removing polyps from this region.

Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma: an Italian multicenter study (MOVIE-GOIRC 01-2014).

PubMed

Passalacqua, Rodolfo; Lazzarelli, Silvia; Donini, Maddalena; Montironi, Rodolfo; Tambaro, Rosa; De Giorgi, Ugo; Pignata, Sandro; Palumbo, Raffaella; Ceresoli, Giovanni Luca; Del Conte, Gianluca; Tonini, Giuseppe; Morelli, Franco; Nolè, Franco; Panni, Stefano; Rondini, Ermanno; Guida, Annalisa; Zucali, Paolo Andrea; Doni, Laura; Iezzi, Elisa; Caminiti, Caterina

2017-07-19

Vinflunine is the only chemotherapeutic agent shown to improve survival in platinum-refractory patients with metastatic transitional cell carcinoma of the urothelium (TCCU) in a phase III clinical trial, which led to product registration for this indication in Europe. The aim of this study was to assess the efficacy of vinflunine and to evaluate the prognostic significance of risk factors in a large, unselected cohort of patients with metastatic TCCU treated according to routine clinical practice. This was a retrospective multicenter study. Italian cancer centers were selected if, according to the Registry of the Italian Medicines Agency (AIFA), at least four patients had been treated with vinflunine between February 2011 and June 2014, after first- or second-line platinum-based chemotherapy. The primary objective was to test whether the efficacy measured by overall survival (OS) in the registration study could be confirmed in routine clinical practice. Multivariate analysis was carried out using Cox proportional hazard model. A total of 217 patients were treated in 28 Italian centers. Median age was 69 years (IQR 62-76) and 84% were male; Eastern Cooperative Oncology Group performance status (ECOG PS) was ≥ 1 in 53% of patients. The median number of cycles was 4 (IQR 2-6); 29%, 35%, and 36% received an initial dose of 320 mg/m 2 , 280 mg/m 2 or a lower dose, respectively. Median progression-free survival (PFS) and OS for the entire population was 3.2 months (2.6-3.7) and 8.1 months (6.3-8.9). A complete response was observed in six patients, partial response in 21, stable disease in 60, progressive disease in 108, with a disease control rate of 40%. Multivariate analysis showed that ECOG PS, number of metastatic sites and liver involvement were unfavorable prognostic factors for OS. Toxicity was mild, and grade 3-4 adverse effects were mainly: neutropenia (9%), anemia (6%), asthenia/fatigue (7%) and constipation (5%). In routine clinical practice the results obtained with VFL seem to be better than the results of the registration trial and reinforce evidence supporting its use after failure of a platinum-based chemotherapy.

Multicenter observational prehospital resuscitation on helicopter study.

PubMed

Holcomb, John B; Swartz, Michael D; DeSantis, Stacia M; Greene, Thomas J; Fox, Erin E; Stein, Deborah M; Bulger, Eileen M; Kerby, Jeffrey D; Goodman, Michael; Schreiber, Martin A; Zielinski, Martin D; O'Keeffe, Terence; Inaba, Kenji; Tomasek, Jeffrey S; Podbielski, Jeanette M; Appana, Savitri N; Yi, Misung; Wade, Charles E

2017-07-01

Earlier use of in-hospital plasma, platelets, and red blood cells (RBCs) has improved survival in trauma patients with severe hemorrhage. Retrospective studies have associated improved early survival with prehospital blood product transfusion (PHT). We hypothesized that PHT of plasma and/or RBCs would result in improved survival after injury in patients transported by helicopter. Adult trauma patients transported by helicopter from the scene to nine Level 1 trauma centers were prospectively observed from January to November 2015. Five helicopter systems had plasma and/or RBCs, whereas the other four helicopter systems used only crystalloid resuscitation. All patients meeting predetermined high-risk criteria were analyzed. Patients receiving PHT were compared with patients not receiving PHT. Our primary analysis compared mortality at 3 hours, 24 hours, and 30 days, using logistic regression to adjust for confounders and site heterogeneity to model patients who were matched on propensity scores. Twenty-five thousand one hundred eighteen trauma patients were admitted, 2,341 (9%) were transported by helicopter, of which 1,058 (45%) met the highest-risk criteria. Five hundred eighty-five of 1,058 patients were flown on helicopters carrying blood products. In the systems with blood available, prehospital median systolic blood pressure (125 vs 128) and Glasgow Coma Scale (7 vs 14) was significantly lower, whereas median Injury Severity Score was significantly higher (21 vs 14). Unadjusted mortality was significantly higher in the systems with blood products available, at 3 hours (8.4% vs 3.6%), 24 hours (12.6% vs 8.9%), and 30 days (19.3% vs 13.3%). Twenty-four percent of eligible patients received a PHT. A median of 1 unit of RBCs and plasma were transfused prehospital. Of patients receiving PHT, 24% received only plasma, 7% received only RBCs, and 69% received both. In the propensity score matching analysis (n = 109), PHT was not significantly associated with mortality at any time point, although only 10% of the high-risk sample were able to be matched. Because of the unexpected imbalance in systolic blood pressure, Glasgow Coma Scale, and Injury Severity Score between systems with and without blood products on helicopters, matching was limited, and the results of this study are inconclusive. With few units transfused to each patient and small outcome differences between groups, it is likely large, multicenter, randomized studies will be required to detect survival differences in this important population. Level II.

Multicenter Observational Prehospital Resuscitation on Helicopter Study (PROHS)

PubMed Central

Holcomb, John B.; Swartz, Michael D.; DeSantis, Stacia M.; Greene, Thomas J.; Fox, Erin E.; Stein, Deborah M.; Bulger, Eileen M.; Kerby, Jeffrey D.; Goodman, Michael; Schreiber, Martin A.; Zielinski, Martin D.; O’Keeffe, Terence; Inaba, Kenji; Tomasek, Jeffrey S.; Podbielski, Jeanette M.; Appana, Savitri; Yi, Misung; Wade, Charles E.

2017-01-01

BACKGROUND Earlier use of in-hospital plasma, platelets and red blood cells (RBCs) has improved survival in trauma patients with severe hemorrhage. Retrospective studies have associated improved early survival with prehospital blood product transfusion (PHT). We hypothesized that PHT of plasma and/or RBCs would result in improved survival after injury in patients transported by helicopter. METHODS Adult trauma patients transported by helicopter from the scene to nine Level 1 trauma centers were prospectively observed from Jan–Nov 2015. Five helicopter systems had plasma and/or RBCs while the other four helicopter systems used only crystalloid resuscitation. All patients meeting predetermined high risk criteria were analyzed. Patients receiving PHT were compared to patients not receiving PHT. Our primary analysis compared mortality at 3 hours, 24 hours, and 30 days, using logistic regression to adjust for confounders and site heterogeneity to model patients who were matched on propensity scores. RESULTS 25,118 trauma patients were admitted, 2341 (9%) were transported by helicopter, of which 1058 (45%) met the highest risk criteria. 585/1058 patients were flown on helicopters carrying blood products. In the systems with blood available, prehospital median systolic blood pressure (125 vs 128) and GCS (7 vs 14) was significantly lower, while median ISS was significantly higher (21 vs 14). Unadjusted mortality was significantly higher in the systems with blood products available, at 3 (8.4% vs 3.6%), 24 (12.6% vs 8.9%) hours and 30 days (19.3% vs 13.3%). 24% of eligible patients received a prehospital transfusion. A median of 1 unit of RBCs and plasma were transfused prehospital. Of patients receiving PHT, 24% received only plasma, 7% received only RBCs and 69% received both. In the propensity score matching analysis (n=109), PHT was not significantly associated with mortality at any time point, although only 10% of the high risk sample were able to be matched. CONCLUSIONS Because of the unexpected imbalance in systolic blood pressure, GCS and ISS between systems with and without blood products on helicopters, matching was limited and the results of this study are inconclusive. With few units transfused to each patient and small outcome differences between groups, it is likely large, multicenter, randomized studies will be required to detect survival differences in this important population. PMID:28383476

The impact of medically indicated and spontaneous preterm birth among hypertensive women.

PubMed

Kase, Benjamin A; Carreno, Carlos A; Blackwell, Sean C; Sibai, Baha M

2013-11-01

To (1) describe the frequency of spontaneous preterm birth (SPTB) and medically indicated preterm birth (PTB) among women with chronic hypertension (CHTN) and (2) to evaluate differences in neonatal outcomes according to SPTB or medically indicated PTB. Retrospective analysis of a previously conducted multicenter randomized trial. Deliveries were categorized as SPTB or medically indicated and stratified by gestational ages (<37 weeks, 34 to 366/7 weeks, 30 to 336/7 weeks, < 30 weeks). Rates of neonatal intensive care unit admission, composite respiratory morbidity, perinatal mortality, and small for gestational age (SGA) were evaluated. Of 765 women, 32.2% (n = 246) delivered at < 37 weeks, of which 10.5% (n = 80) were SPTB and 21.6% (n = 166) were medically indicated. Fifty-nine percent of PTBs occurred in the late preterm period (n = 146). SGA was significantly more frequent among those with medically indicated PTB at < 30 weeks (p = 0.03). There were no other differences in adverse neonatal outcomes between medically indicated versus SPTB at any gestational age (p > 0.05). Nearly one-third of women with CHTN delivered preterm. The majority of PTBs were medically indicated and late preterm, but approximately one-third were due to SPTB. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Predictors of Mortality in Patients with Penetrating Inferior Vena Cava Injuries Surviving to the Operating Room.

PubMed

Maciel, James D; Plurad, David; Gifford, Edward; deVirgilio, Christian; Koopmann, Matt; Neville, Angela; Putnam, Brant; Kim, Dennis Y

2015-10-01

Inferior vena cava (IVC) injuries are associated with significant morbidity and mortality. To identify clinical factors associated with mortality in patients undergoing operative intervention for penetrating IVC injuries, a retrospective review of 98 patients was performed, excluding blunt injuries (n = 20) and deaths before surgery (n = 16). The overall mortality was 58 per cent. Nonsurvivors more commonly presented with hypotension (50% vs 23%, P = 0.03) and underwent resuscitative thoracotomy more frequently (42% vs 4%, P = 0.01). Retrohepatic injuries were more common among nonsurvivors (P = 0.04). There was no difference in the use of ligation (7% vs 17%, P = 0.29) or the massive transfusion protocol (35% vs 25%, P = 0.41). On multivariate analysis, after controlling for mechanism of injury, admission hypotension, Glasgow Coma Scale score , preoperative cumulative fluids, resuscitative thoracotomy , absence of spontaneous tamponade, and location of IVC injury, the only independent predictor of mortality was the absence of spontaneous tamponade at the time of laparotomy (odds ratio = 5.4, 95% confidence interval: 1.11-25.95; P = 0.04). Penetrating IVC injuries continue to be associated with a high mortality, particularly among patients with free intraabdominal hemorrhage at laparotomy. Large multicenter studies are required to define the optimal resuscitative and operative management techniques in these severely injured patients.

Can treatment success with 5% lidocaine medicated plaster be predicted in cancer pain with neuropathic components or trigeminal neuropathic pain?

PubMed Central

Kern, Kai-Uwe; Nalamachu, Srinivas; Brasseur, Louis; Zakrzewska, Joanna M

2013-01-01

An expert group of 40 pain specialists from 16 countries performed a first assessment of the value of predictors for treatment success with 5% lidocaine-medicated plaster in the management of cancer pain with neuropathic components and trigeminal neuropathic pain. Results were based on the retrospective analysis of 68 case reports (sent in by participants in the 4 weeks prior to the conference) and the practical experience of the experts. Lidocaine plaster treatment was mostly successful for surgery or chemotherapy-related cancer pain with neuropathic components. A dose reduction of systemic pain treatment was observed in at least 50% of all cancer pain patients using the plaster as adjunct treatment; the presence of allodynia, hyperalgesia or pain quality provided a potential but not definitively clear indication of treatment success. In trigeminal neuropathic pain, continuous pain, severe allodynia, hyperalgesia, or postherpetic neuralgia or trauma as the cause of orofacial neuropathic pain were perceived as potential predictors of treatment success with lidocaine plaster. In conclusion, these findings provide a first assessment of the likelihood of treatment benefits with 5% lidocaine-medicated plaster in the management of cancer pain with neuropathic components and trigeminal neuropathic pain and support conducting large, well-designed multicenter studies. PMID:23630431

The Applicability of the International Staging System in Chinese Patients with Multiple Myeloma Receiving Bortezomib or Thalidomide-Based Regimens as Induction Therapy: A Multicenter Analysis

PubMed Central

Lu, Jing; Lu, Jin; Liu, Aijun; Fu, Weijun; Du, Juan; Huang, Xiaojun; Chen, Wenming; Hou, Jian

2015-01-01

The International Staging System (ISS) is the most important prognostic system for multiple myeloma (MM). It was identified in the era of conventional agents. The outcome of MM has significantly changed by novel agents. Thus the applicability of ISS system in the era of novel agents in Chinese patients needs to be demonstrated. We retrospectively analyzed the clinical outcomes and prognostic significance of ISS system in 1016 patients with newly diagnosed multiple myeloma in Chinese patients between 2008 and 2012, who received bortezomib- or thalidomide-based regimens as first-line therapy. The median overall survival (OS) of patients for ISS stages I/II/III was not reached/55.4 months/41.7 months (p < 0.001), and the median progression-free survival (PFS) was 30/29.5/25 months (p = 0.072), respectively. Statistically significant difference in survival was confirmed among three ISS stages in thalidomide-based group, but not between ISS stages I and II in bortezomib-based group. These findings suggest that ISS system can predict the survival in the era of novel agents in Chinese MM patients, and bortezomib may have the potential to partially overcome adverse effect of risk factors on survival, especially in higher stage of ISS system. PMID:26640799

Oral care with vancomycin paste for reduction in incidence of alpha-hemolytic streptococcal sepsis.

PubMed

Barker, G J; Call, S K; Gamis, A S

1995-05-01

alpha-Hemolytic streptococcal (AHS) sepsis is increasing in oncology patients receiving myelosuppressive chemotherapy. In response to a high rate of AHS sepsis in this population at our institution, an oral care protocol was instituted, including vancomycin 0.5% in flavored methylcellulose (vanc paste) applied orally t.i.d. at the oncologists' discretion. A retrospective cohort study of 239 neutropenic episodes among 42 children receiving myelosuppressive chemotherapy between 1988 and 1991 compared the incidence of septicemia based on the prophylactic use of vanc paste. A total of 236 consecutive neutropenic episodes were evaluable, 121 with vanc paste and 115 without. AHS sepsis occurred in one child using vanc paste and in six children not using vanc paste (p = 0.06). Excluding staph-only positive blood cultures, which would not be reduced with a topical oral antibiotic drug, there were 6 and 13 positive blood cultures in the vanc-paste and nonvanc-paste patients, respectively (p = 0.09). There was no increase in incidence of gram-negative bacteremia among vanc-paste recipients. Vancomycin resistance was not encountered. This analysis suggests that vanc paste effectively reduces AHS sepsis, does not increase gram-negative bacteremia, and is not associated with vancomycin resistance. A multicentered, placebo-controlled, double-blind study is currently planned.

Genotype-Phenotype Relationship in Patients and Relatives with SHOX Region Anomalies in the French Population.

PubMed

Auger, Julie; Baptiste, Amandine; Benabbad, Imane; Thierry, Gaëlle; Costa, Jean-Marc; Amouyal, Mélanie; Kottler, Marie-Laure; Leheup, Bruno; Touraine, Renaud; Schmitt, Sébastien; Lebrun, Marine; Cormier Daire, Valérie; Bonnefont, Jean-Paul; de Roux, Nicolas; Elie, Caroline; Rosilio, Myriam

2016-01-01

The aim of our study was to describe a large population with anomalies involving the SHOX region, responsible for idiopathic short stature and Léri-Weill dyschondrosteosis (LWD), and to identify a possible genotype/phenotype correlation. We performed a retrospective multicenter study on French subjects with a SHOX region anomaly diagnosed by multiplex ligation-dependent probe amplification or Sanger sequencing. Phenotypes were collected in each of the 7 genetic laboratories practicing this technique for SHOX analysis. Among 205 index cases and 100 related cases, 91.3% had LWD. For index cases, median age at evaluation was 11.7 (9.0; 15.9) years and mean height standard deviation score was -2.3 ± 1.1. A deletion of either SHOX or PAR1 or both was found in 74% of patients. Duplications and point mutations/indels affected 8 and 18% of the population, respectively. Genotype-phenotype correlation showed that deletions were more frequently associated with Madelung deformity and mesomelic shortening in girls, as well as with presence of radiologic anomalies, than duplications. Our results highlight genotype-phenotype relationships in the French population with a SHOX defect and provide new information showing that clinical expression is milder in cases of duplication compared to deletions. © 2016 S. Karger AG, Basel.

Endovascular repair of ruptured abdominal aortic aneurysms: experience in a community hospital.

PubMed

Davit, Flavia E; Cole, Theresa; Helling, Thomas; Tretter, James

2007-11-01

The endovascular technique has been recently used as an alternative procedure for selected patients with ruptured abdominal aortic aneurysm (RAAA) as a result of the potential for decreasing morbidity, mortality, and recovery time. We examined our institution's results with endovascular repair of RAAA. Between July 2005 and April 2006, four patients underwent endovascular repair of infrarenal RAAA. We performed a retrospective analysis of our comorbidities, operation time, length of intensive care unit and hospital stay, morbidity and mortality, blood transfusions, and secondary interventions on these patients at our institution. The median age was 73.2 years (range, 66-82 years); 75 per cent were male and 25 per cent were female. Mean operating time was 90 minutes. We had no operative or postoperative mortalities. Five complications occurred in three patients. These included acute renal failure, common femoral artery intimal dissection, graft thrombosis of the iliac limb, ischemic colitis, and chronic obstructive pulmonary disease exacerbation. Endovascular repair of RAAA by an endovascular team is feasible in the community hospital setting. Our limited number of patients in this study does not allow us to compare it directly with results from the standard open procedure. A larger, multicenter study may eventually show this method to be helpful in patients who require repair of RAAA.

Long-Term Survival in Patients Receiving a Continuous-Flow Left Ventricular Assist Device.

PubMed

Gosev, Igor; Kiernan, Michael S; Eckman, Peter; Soleimani, Behzad; Kilic, Ahmet; Uriel, Nir; Rich, Jonathan D; Katz, Jason N; Cowger, Jennifer; Lima, Brian; McGurk, Siobhan; Brisco-Bacik, Meredith A; Lee, Sanjin; Joseph, Susan M; Patel, Chetan B

2018-03-01

Long-term survivors after implantation of left ventricular assist devices (LVADs) are increasing in prevalence. We describe the characteristics and outcomes in patients surviving longer than 4 years on LVAD support. We performed a multicenter, retrospective analysis of patients surviving at least 4 years on continuous-flow LVAD (CF-LVAD) support with a HeartMate II at centers participating in the Evolving Mechanical support Research Group. Between 2005 and 2010, 156 long-term survivors were identified with a mean survival of 7.1 years (95% confidence interval: 6.7 to 7.5 years). The mean age was 58.2 ± 15.2 years and 30.1% were women. Readmission rate was low at 1.1 events per patient per year with the most common reasons leading to readmission being infection (0.10 readmissions per patient per year) and gastrointestinal bleeding (0.07 readmissions per patient per year). Two years after implantation, 97% of patients were either New York Heart Association functional class I or II, with 92% at 4 years. Patients surviving 4 years on CF-LVAD support can anticipate ongoing long-term survival with sustained improvements in functionality and low rates of rehospitalization. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Survival Benefit of Tolvaptan for Refractory Ascites in Patients with Advanced Cirrhosis.

PubMed

Tajiri, Kazuto; Tokimitsu, Yoshiharu; Ito, Hiroyuki; Atarashi, Yoshinari; Kawai, Kengo; Minemura, Masami; Yasumura, Satoshi; Takahara, Terumi; Shimizu, Yukihiro; Sugiyama, Toshiro

2018-05-31

The study aimed to evaluate the effects of tolvaptan treatment on survival of patients with decompensated liver cirrhosis with refractory ascites. This multicenter, retrospective, observational study included patients with cirrhosis who were treated with tolvaptan for hepatic ascites refractory to conventional diuretics. Patients who could and could not decrease accompanying diuretics within 1 month after tolvaptan administration were defined as the "Decreased" and "Not-decreased" groups, respectively. Median body weight change 1 week after tolvaptan treatment was -1.95 kg, with the 50% of patients experiencing a 2 kg/week reduction. Spot urinary sodium was found to be a better predictor of tolvaptan response than liver function and liver fibrosis markers. Median survival was significantly longer (not reached versus 116 days, p = 0.005) and serum creatinine concentrations 12 weeks after tolvaptan administration significantly lower (0.99 vs. 1.55 mg/dL, p < 0.05) in the Decreased than in the Not-decreased group. Multivariate analysis showed that the presence of viable hepatocellular carcinoma (hazards ratio [HR] 2.14, p = 0.02) and a decrease in diuretics were independently prognostic of survival (HR 0.36, p < 0.01). The maintenance of renal function is essential in enhancing survival of patients with cirrhosis. Doses of diuretics should be adjusted appropriately during tolvaptan treatment. © 2018 S. Karger AG, Basel.

A practical scoring system to predict mortality in patients with perforated peptic ulcer.

PubMed

Menekse, Ebru; Kocer, Belma; Topcu, Ramazan; Olmez, Aydemir; Tez, Mesut; Kayaalp, Cuneyt

2015-01-01

The mortality rate of perforated peptic ulcer is still high particularly for aged patients and all the existing scoring systems to predict mortality are complicated or based on history taking which is not always reliable for elderly patients. This study's aim was to develop an easy and applicable scoring system to predict mortality based on hospital admission data. Total 227 patients operated for perforated peptic ulcer in two centers were included. All data that may be potential predictors with respect to hospital mortality were retrospectively analyzed. The mortality and morbidity rates were 10.1% and 24.2%, respectively. Multivariated analysis pointed out three parameters corresponding 1 point for each which were age >65 years, albumin ≤1,5 g/dl and BUN >45 mg/dl. Its prediction rate was high with 0,931 (95% CI, 0,890 to 0,961) value of AUC. The hospital mortality rates for none, one, two and three positive results were zero, 7.1%, 34.4% and 88.9%, respectively. Because the new system consists only age and routinely measured two simple laboratory tests (albumin and BUN), its application is easy and prediction power is satisfactory. Verification of this new scoring system is required by large scale multicenter studies.

Urolithiasis in Tunisian children: a study of 100 cases.

PubMed

Alaya, Akram; Nouri, Abdellatif; Najjar, Mohamed Fadhel

2009-11-01

The aim of this study is to assess the clinical and biological characteristics of renal stone disease among children living in the coastal region of Tunisia. This retrospective multi-center study included 100 children under the age of 16 years, who presented with urinary stones. The patients' charts were reviewed with regard to age at diagnosis, sex, history and physical examination as well as laboratory and radiologic findings. Stone analysis was performed by infrared spectrophotometry. The male/female sex ratio was 1.5 to 1. The clinical presentation of this pathology was dominated by dysuria. Stones were located in the upper urinary tract in 76 cases (76%). A total of 13% of the study subjects had positive urine cultures. Metabolic investigations were performed in all patients and were normal in 80 cases. Whewellite (calcium oxalate) was found in 77 stones (77.0%). Stone section was made of whewellite in 69.0% of cases and ammonium urate in 47.0%. Struvite stones were more frequently seen in the lower urinary tract. Our study suggests that the epidemiological profile of renal stones in Tunisia has changed towards a predominance of calcium oxalate stones and upper tract location. Also, the male predominance of pediatric urolithiasis is becoming less obvious in Tunisia.

MRI-based assessment of the pineal gland in a large population of children aged 0-5 years and comparison with pineoblastoma: part II, the cystic gland.

PubMed

Sirin, Selma; de Jong, Marcus C; Galluzzi, Paolo; Maeder, Philippe; Brisse, Hervé J; Castelijns, Jonas A; de Graaf, Pim; Goericke, Sophia L

2016-07-01

Pineal cysts are a common incidental finding on brain MRI with resulting difficulties in differentiation between normal glands and pineal pathologies. The aim of this study was to assess the size and morphology of the cystic pineal gland in children (0-5 years) and compare the findings with published pineoblastoma cases. In this retrospective multicenter study, 257 MR examinations (232 children, 0-5 years) were evaluated regarding pineal gland size (width, height, planimetric area, maximal cyst(s) size) and morphology. We performed linear regression analysis with 99 % prediction intervals of gland size versus age for the size parameters. Results were compared with a recent meta-analysis of pineoblastoma by de Jong et al. Follow-up was available in 25 children showing stable cystic findings in 48 %, cyst size increase in 36 %, and decrease in 16 %. Linear regression analysis gave 99 % upper prediction bounds of 10.8 mm, 10.9 mm, 7.7 mm and 66.9 mm(2), respectively, for cyst size, width, height, and area. The slopes (size increase per month) of each parameter were 0.030, 0.046, 0.021, and 0.25, respectively. Most of the pineoblastomas showed a size larger than the 99 % upper prediction margin, but with considerable overlap between the groups. We presented age-adapted normal values for size and morphology of the cystic pineal gland in children aged 0 to 5 years. Analysis of size is helpful in discriminating normal glands from cystic pineal pathologies such as pineoblastoma. We also presented guidelines for the approach of a solid or cystic pineal gland in hereditary retinoblastoma patients.

Spine device clinical trials: design and sponsorship.

PubMed

Cher, Daniel J; Capobianco, Robyn A

2015-05-01

Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (p<.0001) and larger sample sizes. There were very few US-based multicenter randomized trials of spine devices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

Macroscopy predicts tumor progression in gastric cancer: A retrospective patho-historical analysis based on Napoleon Bonaparte's autopsy report.

PubMed

Dawson, Heather; Novotny, Alexander; Becker, Karen; Reim, Daniel; Langer, Rupert; Gullo, Irene; Svrcek, Magali; Niess, Jan H; Tutuian, Radu; Truninger, Kaspar; Diamantis, Ioannis; Blank, Annika; Zlobec, Inti; Riddell, Robert H; Carneiro, Fatima; Fléjou, Jean-François; Genta, Robert M; Lugli, Alessandro

2016-11-01

The cause of Napoleon Bonaparte's death remains controversial. Originally suggested to be gastric cancer, whether this was truly neoplastic or a benign lesion has been recently debated. To interpret findings of original autopsy reports in light of the current knowledge of gastric cancer and to highlight the significance of accurate macroscopy in modern-day medicine. Using original autopsy documents, endoscopic images and data from current literature, Napoleon's gastric situation was reconstructed. In a multicenter collection of 2071 gastric cancer specimens, the relationship between tumor size and features of tumor progression was assessed. Greater tumor size was associated with advanced pT, nodal metastases and Borrmann types 3-4 (p<0.001). The best cut-off for predicting pT3-4 tumors was 6.5cm (AUC 0.8; OR 1.397, 95% CI 1.35-1.446), and 6cm for lymph node metastases (AUC 0.775; OR 1.389, 95% CI 1.338-1.442). The 6cm cut-off of had a positive predictive value of 0.820 for nodal metastases and a negative predictive value of 0.880 for distant metastases. This analysis combines Napoleon's autopsy with present-day knowledge to support gastric cancer as his terminal illness and emphasizes the role of macroscopy, which may provide valuable information on gastric cancer progression and aid patient management. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Frontal Lobe Function and Risk of Hip Fracture in Patient With Alzheimer Disease: An Analysis of Linked Data.

PubMed

Roh, Hyun Woong; Hong, Chang Hyung; Lee, SooJin; Lee, Yunhwan; Lee, Kang Soo; Chang, Ki Jung; Oh, Byoung Hoon; Choi, Seong Hye; Kim, Seong Yoon; Back, Joung Hwan; Chung, Young Ki; Lim, Ki Young; Noh, Jai Sung; Son, Sang Joon

2015-11-01

To determine the association between frontal lobe function and risk of hip fracture in patients with Alzheimer disease (AD).Retrospective cohort study using multicenter hospital-based dementia registry and national health insurance claim data was done. Participants who had available data of neuropsychological test, national health insurance claim, and other covariates were included. A total of 1660 patients with AD were included based on Stroop Test results. A total of 1563 patients with AD were included based on the Controlled Oral Word Association Test (COWAT) results. Hip fracture was measured by validated identification criteria using national health insurance claim data. Frontal lobe function was measured by Stroop Test and COWAT at baseline.After adjusting for potential covariates, including cognitive function in other domains (language, verbal and nonverbal memory, and attention), the Cox proportional hazard regression analysis revealed that risk of a hip fracture was decreased with a hazard ratio (HR) of 0.98 per one point of increase in the Stroop Test (adjusted HR = 0.98, 95% confidence interval [CI]: 0.97-1.00) and 0.93 per one point increase in COWAT (adjusted HR = 0.93, 95% CI: 0.88-0.99).The risk of hip fracture in AD patients was associated with baseline frontal lobe function. The result of this research presents evidence of association between frontal lobe function and risk of hip fracture in patients with AD.

Unlocking echocardiogram measurements for heart disease research through natural language processing.

PubMed

Patterson, Olga V; Freiberg, Matthew S; Skanderson, Melissa; J Fodeh, Samah; Brandt, Cynthia A; DuVall, Scott L

2017-06-12

In order to investigate the mechanisms of cardiovascular disease in HIV infected and uninfected patients, an analysis of echocardiogram reports is required for a large longitudinal multi-center study. A natural language processing system using a dictionary lookup, rules, and patterns was developed to extract heart function measurements that are typically recorded in echocardiogram reports as measurement-value pairs. Curated semantic bootstrapping was used to create a custom dictionary that extends existing terminologies based on terms that actually appear in the medical record. A novel disambiguation method based on semantic constraints was created to identify and discard erroneous alternative definitions of the measurement terms. The system was built utilizing a scalable framework, making it available for processing large datasets. The system was developed for and validated on notes from three sources: general clinic notes, echocardiogram reports, and radiology reports. The system achieved F-scores of 0.872, 0.844, and 0.877 with precision of 0.936, 0.982, and 0.969 for each dataset respectively averaged across all extracted values. Left ventricular ejection fraction (LVEF) is the most frequently extracted measurement. The precision of extraction of the LVEF measure ranged from 0.968 to 1.0 across different document types. This system illustrates the feasibility and effectiveness of a large-scale information extraction on clinical data. New clinical questions can be addressed in the domain of heart failure using retrospective clinical data analysis because key heart function measurements can be successfully extracted using natural language processing.

Organizational culture affecting quality of care: guideline adherence in perioperative antibiotic use.

PubMed

Ukawa, Naoto; Tanaka, Masayuki; Morishima, Toshitaka; Imanaka, Yuichi

2015-02-01

The objective of this work was to elucidate aspects of organizational culture associated with hospital performance in perioperative antibiotic prophylaxis using quantitative data in a multicenter and multidimensional study. Cross-sectional retrospective study using a survey data and administrative data. Eighty-three acute hospitals in Japan. A total of 4856 respondents in the organizational culture study, and 23 172 patients for the quality indicator analysis. Multilevel models of various cultural dimensions were used to analyze the association between hospital organizational culture and guideline adherence. The dependent variable was adherence or non-adherence to Japanese and CDC guidelines at the patient level and main independent variable was hospital groups categorized according to organizational culture score. Other control variables included hospital characteristics such as ownership, bed capacity, region and urbanization level of location. The multilevel analysis showed that hospitals with a high score in organizational culture were more likely to adhere to the Japanese and CDC guidelines when compared with lower scoring hospitals. In particular, the hospital group with high scores in the 'collaboration' and 'professional growth' dimensions had three times the odds for Japanese guideline adherence in comparison with low-scoring hospitals. Our study revealed that various aspects of organizational culture were associated with adherence to guidelines for perioperative antibiotic use. Hospital managers aiming to improve quality of care may benefit from improving hospital organizational culture. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Should We Pay Attention to the Delay Before Admission to a Pediatric Intensive Care Unit for Children With Cancer? Impact on 1-Month Mortality. A Report From the French Children's Oncology Study Group, GOCE.

PubMed

Fausser, Jeanne-L; Tavenard, Aude; Rialland, Fanny; Le Moine, Philippe; Minckes, Odile; Jourdain, Anne; Tirel, Olivier; Pellier, Isabelle; Gandemer, Virginie

2017-07-01

Acute complications requiring admission to pediatric intensive care unit (PICU) are frequent for children with cancer. Our objective was to determine early prognostic factors of mortality in a cohort of children with cancer hospitalized in PICU for acute complications and particularly to assess whether the delay before admission to a PICU is an early predictor of mortality. We conduct a retrospective multicenter analysis. All patients transferred in PICU for acute complications between January 2002 and December 2012 were included. One-month mortality of the 224 patients analyzed was 24.5%. Delay before PICU admission was a significant prognostic factor of 1-month mortality with nonsurvivors experiencing a longer median delay than survivors (24 vs. 12 h, respectively, P<0.05). Time from diagnosis to PICU admission (P<0.001), hematopoietic stem cell transplant (P<0.05), the duration of neutropenia (P<0.01), infection type (P<0.001), number of organ dysfunctions (P<0.001), and reaching any grade 4 toxicity before PICU admission (P<0.001) also affected mortality rate at 1-month post-PICU discharge. In the multivariate analysis, only reaching any grade 4 toxicity before PICU admission influenced 1-month mortality (odds ratio, 2.30; 95% confidence interval, 1.07-4.96; P<0.05). These results suggest that PICU admission before severe impairment leads to a better outcome for children with cancer.

Venous thromboembolism in women undergoing pelvic reconstructive surgery with mechanical prophylaxis alone.

PubMed

Montoya, T Ignacio; Leclaire, Edgar L; Oakley, Susan H; Crane, Andrea K; Mcpencow, Alexandra; Cichowski, Sara; Rahn, David D

2014-07-01

The objective of this study was determine the frequency of symptomatic perioperative venous thromboembolism (VTE) and risk factor(s) associated with VTE occurrence in women undergoing elective pelvic reconstructive surgery using only intermittent pneumatic compression (IPC) for VTE prophylaxis. A multi-center case-cohort retrospective review was conducted at six clinical sites over a 66-month period. All sites utilize IPC as standard VTE prophylaxis for urogynecological surgery. VTE cases occurring during the same hospitalization and up to 6 weeks postoperatively were identified by ICD9 code query. Four controls were temporally matched to each case. Information collected included demographics, medical history, route of surgery, operative time, and intraoperative characteristics. Univariate and multivariate backward stepwise logistic regression analyses were performed to identify potential risk factors for VTE. Symptomatic perioperative VTE was diagnosed in 27 subjects from a cohort of 10,627 women who underwent elective urogynecological surgery (0.25 %). Univariate analysis identified surgical route (laparotomy vs others), type of surgery ("major" vs "minor"), history of gynecological cancer, surgery time, and patient age as risk factors for VTE (P < 0.05). Multivariate analysis identified increased frequency of VTE with laparotomy, age ≥ 70, and surgery duration ≥ 5 h. In our study cohort, the frequency of symptomatic perioperative VTE was low. Laparotomy, age ≥ 70 years, and surgery duration ≥ 5 h were associated with VTE occurrence.

77 FR 65645 - Retrospective Analysis of Existing Rules: Notice of Staff Memorandum

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-30

...] Retrospective Analysis of Existing Rules: Notice of Staff Memorandum SUMMARY: Take notice that the Commission... Analysis of Existing Rules prepared in response to Executive Order 13579, which requested independent regulatory agencies issue plans for periodic retrospective analysis of their existing regulations. [[Page...

[Bibliometric analysis of scientific articles on epidemiological study of burns in China].

PubMed

Cheng, W F; Shen, Z A; Zhao, D X; Li, D W; Shang, Y R

2017-04-20

Objective: To analyze the current status of epidemiological study of burns in China, and to explore the related strategies. Methods: Retrospective or cross-sectional scientific articles in Chinese or English on epidemiological study of burns in China published from January 2005 to December 2015 were systemically retrieved from 4 databases. The databases include PubMed, Embase, China Biology Medicine disc, and Chinese Journals Full - text Database . From the results retrieved, data with regard to publication year, journal distribution, number of institutions participated in the study, affiliation of the first author and its location, and admission time span and age of patients in all the scientific articles were collected. Furthermore, the definition of age range and the grouping method of age of pediatric patients in English articles on epidemiological study of pediatric burns of China were recorded. Data were processed with descriptive statistical analysis. Results: A total of 256 scientific articles conforming to the study criteria were retrieved, among which 214 (83.59%) articles were in Chinese, and 42 (16.41%) articles were in English; 242 (94.53%) articles were retrospective studies, and 14 (5.47%) articles were cross-sectional studies. During the 11 years, the number of the relevant articles was fluctuant on the whole. The scientific articles were published in 130 journals, with 42 English articles in source journals for SCIENCE CITATION INDEX EXPANDED - JOURNAL LIST, accounting for 16.41%, and 116 Chinese articles in Source Journal for Chinese Scientific and Technical Papers, accounting for 45.31%. Totally 215 (83.98%) articles were single-center studies, and 29 (11.33%) articles were multicenter studies which were conducted by three or more centers. The number of affiliations of the first author of articles was 161 in total. The top 10 institutions regarding the article publishing number published 58 articles, accounting for 22.66%. Scientific articles on epidemiological study of burns were retrieved with location of affiliation of the first author in 31 provinces, autonomous regions, and municipalities directly under the Central Government in Mainland China, and also in Taiwan Province and Hong Kong Special Administrative Region, among which Shanghai ranked first with 24 (9.38%) articles published. The admission time span of patients in the articles ranged from 3 months to 47 years, with 120 (46.87%) articles from 3 months to 5 years, 79 (30.86%) articles from 6 to 10 years, and 57 (22.27%) articles more than 10 years, respectively. Regarding the age of patients in the study, 123 articles were on epidemiological study of pediatric burns, and 16 articles on epidemiological study of elderly burns, accounting for 48.05% and 6.25%, respectively. Further analysis of articles on epidemiological study of pediatric burns in English showed that there was no standard definition of age range or unified grouping method of age for pediatric burn patients. Conclusions: The epidemiological study of burns in China has been carried out nationwide, but the number of institutions conducted relevant study is not that much, and multicenter epidemiological studies remain scanty. The quality of the articles needs to be further improved. The epidemiological study of elderly burns is relatively deficient and calls for more attention. The epidemiological study of burns in China lacks regularity or continuity in time scope. There is an urgent need for the guideline on classification method for items of epidemiological study of burns in China so as to standardize the related research.

Study of the Factors Leading to Fetal and Neonatal Dysthyroidism in Children of Patients With Graves Disease.

PubMed

Banigé, Maïa; Estellat, Candice; Biran, Valerie; Desfrere, Luc; Champion, Valerie; Benachi, Alexandra; Ville, Yves; Dommergues, Marc; Jarreau, Pierre-Henri; Mokhtari, Mostafa; Boithias, Claire; Brioude, Frederic; Mandelbrot, Laurent; Ceccaldi, Pierre-François; Mitanchez, Delphine; Polak, Michel; Luton, Dominique

2017-06-01

Neonatal hyperthyroidism was first described in 1912 and in 1964 was shown to be linked to transplacental passage of maternal antibodies. Few multicenter studies have described the perinatal factors leading to fetal and neonatal dysthyroidism. To show how fetal dysthyroidism (FD) and neonatal dysthyroidism (ND) can be predicted from perinatal variables, in particular, the levels of anti-thyrotropin receptor antibodies (TRAbs) circulating in the mother and child. This was a retrospective multicenter study of data from the medical records of all patients monitored for pregnancy from 2007 to 2014. Among 280,000 births, the medical records of 2288 women with thyroid dysfunction were selected and screened, and 417 women with Graves disease and positive for TRAbs during pregnancy were included. Using the maternal TRAb levels, the cutoff value of 2.5 IU/L best predicted for FD, with a sensitivity of 100% and specificity of 64%. Using the newborn TRAb levels, the cutoff value of 6.8 IU/L best predicted for ND, with a sensitivity of 100% and a specificity of 94%. In our study, 65% of women with a history of Graves disease did not receive antithyroid drugs during pregnancy but still had infants at risk of ND. In pregnant women with TRAb levels ≥2.5 IU/L, fetal ultrasound monitoring is essential until delivery. All newborns with TRAb levels ≥6.8 IU/L should be examined by a pediatrician with special attention for thyroid dysfunction and treated, if necessary.

Effect of Performance Deficiencies on Graduation and Board Certification Rates: A 10-Year Multicenter Study of Anesthesiology Residents

PubMed Central

Turner, Judi A.; Fitzsimons, Michael G.; Pardo, Manuel C.; Hawkins, Joy L.; Huang, Yue Ming; Rudolph, Maria D. D.; Keyes, Mary A.; Howard-Quijano, Kimberly J.; Naim, Natale Z.; Buckley, Jack C.; Grogan, Tristan R.; Steadman, Randolph H.

2016-01-01

Background This multi-center, retrospective study was conducted to determine how resident performance deficiencies affect graduation and board certification. Methods Primary documents pertaining to resident performance were examined over a 10-year period at four academic anesthesiology residencies. Residents entering training between 2000 and 2009 were included, with follow-up through February 2016. Residents receiving actions by the programs’ Clinical Competency Committee were categorized by the area of deficiency and compared to peers without deficiencies. Results A total of 865 residents were studied (range: 127–275 per program). Of these, 215 residents received a total of 405 actions from their respective Clinical Competency Committee. Among those who received an action compared to those who did not, the proportion graduating differed (93% versus 99%, respectively, P<0.001), as did the proportion achieving board certification (89% versus 99%, respectively, P<0.001). When a single deficiency in an Essential Attribute (e.g., ethical, honest, respectful behavior; absence of impairment) was identified, the proportion graduating dropped to 55%. When more than three Accreditation Council for Graduate Medical Education core competencies were deficient, the proportion graduating also dropped significantly. Conclusions Overall graduation and board certification rates were consistently high in residents with no, or isolated, deficiencies. Residents deficient in an Essential Attribute, or multiple competencies, are at high risk of not graduating or achieving board certification. More research is needed on the effectiveness and selective deployment of remediation efforts, particularly for high-risk groups. PMID:27119434

Effect of Performance Deficiencies on Graduation and Board Certification Rates: A 10-yr Multicenter Study of Anesthesiology Residents.

PubMed

Turner, Judi A; Fitzsimons, Michael G; Pardo, Manuel C; Hawkins, Joy L; Huang, Yue Ming; Rudolph, Maria D D; Keyes, Mary A; Howard-Quijano, Kimberly J; Naim, Natale Z; Buckley, Jack C; Grogan, Tristan R; Steadman, Randolph H

2016-07-01

This multicenter, retrospective study was conducted to determine how resident performance deficiencies affect graduation and board certification. Primary documents pertaining to resident performance were examined over a 10-yr period at four academic anesthesiology residencies. Residents entering training between 2000 and 2009 were included, with follow-up through February 2016. Residents receiving actions by the programs' Clinical Competency Committee were categorized by the area of deficiency and compared to peers without deficiencies. A total of 865 residents were studied (range: 127 to 275 per program). Of these, 215 residents received a total of 405 actions from their respective Clinical Competency Committee. Among those who received an action compared to those who did not, the proportion graduating differed (93 vs. 99%, respectively, P < 0.001), as did the proportion achieving board certification (89 vs. 99%, respectively, P < 0.001). When a single deficiency in an Essential Attribute (e.g., ethical, honest, respectful behavior; absence of impairment) was identified, the proportion graduating dropped to 55%. When more than three Accreditation Council for Graduate Medical Education Core Competencies were deficient, the proportion graduating also dropped significantly. Overall graduation and board certification rates were consistently high in residents with no, or isolated, deficiencies. Residents deficient in an Essential Attribute, or multiple competencies, are at high risk of not graduating or achieving board certification. More research is needed on the effectiveness and selective deployment of remediation efforts, particularly for high-risk groups.

Study protocol of a multicenter randomized controlled trial of mindfulness training to reduce burnout and promote quality of life in police officers: the POLICE study.

PubMed

Trombka, Marcelo; Demarzo, Marcelo; Bacas, Daniel Campos; Antonio, Sonia Beira; Cicuto, Karen; Salvo, Vera; Claudino, Felipe Cesar Almeida; Ribeiro, Letícia; Christopher, Michael; Garcia-Campayo, Javier; Rocha, Neusa Sica

2018-05-25

Police officers experience a high degree of chronic stress. Policing ranks among the highest professions in terms of disease and accident rates. Mental health is particularly impacted, evidenced by elevated rates of burnout, anxiety and depression, and poorer quality of life than the general public. Mindfulness training has been shown to reduce stress, anxiety, burnout and promote quality of life in a variety of settings, although its efficacy in this context has yet to be systematically evaluated. Therefore, this trial will investigate the efficacy of a mindfulness-based intervention versus a waitlist control in improving quality of life and reducing negative mental health symptoms in police officers. This multicenter randomized controlled trial has three assessment points: baseline, post-intervention, and six-month follow-up. Active police officers (n = 160) will be randomized to Mindfulness-Based Health Promotion (MBHP) or waitlist control group at two Brazilian major cities: Porto Alegre and São Paulo. The primary outcomes are burnout symptoms and quality of life. Consistent with the MBHP conceptual model, assessed secondary outcomes include perceived stress, anxiety and depression symptoms, and the potential mechanisms of resilience, mindfulness, decentering, self-compassion, spirituality, and religiosity. Findings from this study will inform and guide future research, practice, and policy regarding police offer health and quality of life in Brazil and globally. ClinicalTrials.gov NCT03114605 . Retrospectively registered on March 21, 2017.

Rheolytic thrombectomy in the management of limb ischemia: 30-day results from a multicenter registry.

PubMed

Ansel, Gary M; George, Barry S; Botti, Charles F; McNamara, Thomas O; Jenkins, J Stephen; Ramee, Steven R; Rosenfield, Kenneth; Noethen, Alice A; Mehta, Tejas

2002-08-01

To evaluate the use of rheolytic thrombectomy (RT) with the AngioJet catheter for treatment of lower extremity ischemia due to arterial/graft thrombotic occlusion. A retrospective multicenter review was performed of 99 consecutive patients (52 men; mean age 67 +/- 13 years, range 30-90) who underwent RT for thrombotic occlusions in native arteries (n=80) or bypass grafts (n=19). Pre- and postprocedural limb ischemia and in-hospital events were evaluated. Amputation and mortality rates at 30 days were determined. The majority of patients (78.8%) presented within 14 days of symptom onset. RT resulted in substantial to complete thrombus removal in 70 (70.7%) patients and partial in 22 (22.2%); there was no angiographic change in 7 (7.1%). Adjunctive post RT thrombolysis was used in 37 patients. Underlying stenoses found in 81 limbs were treated with one or more of the following procedures: balloon angioplasty (n=62), stenting (n=35), or nonemergent surgical revision (n=5). In-hospital complications included 2 major amputations, 5 cases of minor tissue loss, 7 rethromboses, and 3 cases of transient renal insufficiency. Four (4.0% patients died in-hospital; the 95 surviving patients all had viable limbs at discharge. Mortality and amputation rates at 30 days were 7.1% and 4.0%, respectively. Percutaneous treatment of thrombotic occlusions with RT, followed by definitive treatment of the underlying stenosis, is a promising therapeutic option for patients with limb-threatening ischemia.

Noncutaneous malignant melanoma: a prognostic model from a retrospective multicenter study

PubMed Central

2010-01-01

Background We performed multicenter study to define clinical characteristics of noncutaneous melanomas and to establish prognostic factors patients who received curative resection. Methods Of the 141 patients who were diagnosed of non-cutaneous melanoma at 4 institutions in Korea between June 1992 and May 2005, 129 (91.5%) satisfied the selection criteria. Results Of the 129 noncutaneous melanoma patients, 14 patients had ocular melanoma and 115 patients had mucosal melanoma. For mucosal melanoma, anorectum was the most common anatomic site (n = 39, 30.2%) which was followed by nasal cavity (n = 30, 23.3%), genitourinary (n = 21, 16.3%), oral cavity (n = 14, 10.9%), upper gastrointestinal tract (n = 6, 4.7%) and maxillary sinus (n = 5, 3.9%) in the order of frequency. With the median 64.5 (range 4.3-213.0) months follow-up, the median overall survival were 24.4 months (95% CI 13.2-35.5) for all patients, and 34.6 (95% CI 24.5-44.7) months for curatively resected mucosal melanoma patients. Adverse prognostic factors of survival for 87 curatively resected mucosal melanoma patients were complete resection (R1 resection margin), and age > 50 years. For 14 ocular melanoma, Survival outcome was much better than mucosal melanoma with 73.3% of 2 year OS and 51.2 months of median OS (P = .04). Conclusion Prognosis differed according to primary sites of noncutaneous melanoma. Based on our study, noncutaneous melanoma patients should be treated differently to improve survival outcome. PMID:20426858

Is There a Relationship Between Body Mass Index and Fluoroscopy Time During Sacroiliac Joint Injection? A Multicenter Cohort Study.

PubMed

McCormick, Zachary L; Cushman, Daniel; Lee, David T; Scholten, Paul; Chu, Samuel K; Babu, Ashwin N; Caldwell, Mary; Ziegler, Craig; Ashraf, Humaira; Sundar, Bindu; Clark, Ryan; Gross, Claire; Cara, Jeffrey; McCormick, Kristen; Ross, Brendon; Smith, Clark C; Press, Joel; Smuck, Matthew; Walega, David R

2016-07-01

To determine the relationship between BMI and fluoroscopy time during intra-articular sacroiliac joint (SIJ) injections performed for a pain indication. Multicenter retrospective cohort study. Three academic, outpatient pain treatment centers. Patients who underwent fluoroscopy guided SIJ injection with encounter data regarding fluoroscopy time during the procedure and body mass index (BMI). Median and 25-75% Interquartile Range (IQR) fluoroscopy time. 459 SIJ injections (350 patients) were included in this study. Patients had a median age of 57 (IQR 44, 70) years, and 72% were female. The median BMI in the normal weight, overweight, and obese groups were 23 (IQR 21, 24), 27 (IQR 26, 29), and 35 (IQR 32, 40), respectively. There was no significant difference in the median fluoroscopy time recorded between these BMI classes (p = 0.45). First-time SIJ injection (p = 0.53), bilateral injection (p = 0.30), trainee involvement (p = 0.47), and new trainee involvement (trainee participation during the first 2 months of the academic year) (p = 0.85) were not associated with increased fluoroscopy time for any of the three BMI categories. Fluoroscopy time during sacroiliac joint injection is not increased in patients who are overweight or obese, regardless of whether a first-time sacroiliac joint injection was performed, bilateral injections were performed, a trainee was involved, or a new trainee was involved. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Efficacy of liquid nitrogen cryotherapy for Barrett's esophagus after endoscopic resection of intramucosal cancer: A multicenter study.

PubMed

Trindade, Arvind J; Pleskow, Douglas K; Sengupta, Neil; Kothari, Shivangi; Inamdar, Sumant; Berkowitz, Joshua; Kaul, Vivek

2018-02-01

Liquid nitrogen cryotherapy (LNC) allows increased depth of ablation compared with radiofrequency ablation in Barrett's esophagus (BE). Expert centers may use LNC over radiofrequency ablation to ablate Barrett's esophagus after endoscopic resection of intramucosal cancer (IMCA). The aim of our study was to (1) evaluate the safety and efficacy of LNC ablation in patients with BE and IMCA and (2) to evaluate the progression to invasive disease despite therapy. This was a multicenter, retrospective study of consecutive patients with BE who received LNC following endoscopic mucosal resection (EMR) of IMCA. The outcomes evaluated were complete eradication of dysplasia and intestinal metaplasia and development of invasive cancer during follow up. The follow-up period was at least 1 year from initial LNC. Twenty-seven patients were identified. The median Prague score was C3M5 (range C0M1-C14M14). After EMR+LNC, the median Prague score was C0M1 (range C0M0-C9M10); 22/27 patients (82%) achieved complete eradication of dysplasia after cryotherapy, and 19/27 patients (70%) achieved complete eradication of intestinal metaplasia. One out of 27 patients (4%) developed invasive cancer (disease beyond IMCA) over the study period. Cryotherapy is an effective endoscopic tool for eradication of BE dysplasia after EMR for IMCA. Development of invasive cancer is low for this high-risk group. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

GSTA1 diplotypes affect busulfan clearance and toxicity in children undergoing allogeneic hematopoietic stem cell transplantation: a multicenter study.

PubMed

Ansari, Marc; Curtis, Patricia Huezo-Diaz; Uppugunduri, Chakradhara Rao S; Rezgui, Mohammed Aziz; Nava, Tiago; Mlakar, Vid; Lesne, Laurence; Théoret, Yves; Chalandon, Yves; Dupuis, Lee L; Schechter, Tao; Bartelink, Imke H; Boelens, Jaap J; Bredius, Robbert; Dalle, Jean-Hugues; Azarnoush, Saba; Sedlacek, Petr; Lewis, Victor; Champagne, Martin; Peters, Christina; Bittencourt, Henrique; Krajinovic, Maja

2017-10-31

Busulfan (BU) dose adjustment following therapeutic drug monitoring contributes to better outcome of hematopoietic stem cell transplantation (HSCT). Further improvement could be achieved through genotype-guided BU dose adjustments. To investigate this aspect, polymorphism within glutathione S transferase genes were assessed. Particularly, promoter haplotypes of the glutathione S transferase A1 ( GSTA1 ) were evaluated in vitro, with reporter gene assays and clinically, in a pediatric multi-center study (N =138) through association with BU pharmacokinetics (PK) and clinical outcomes. Promoter activity significantly differed between the GSTA1 haplotypes (p<0.001) supporting their importance in capturing PK variability. Four GSTA1 diplotype groups that significantly correlated with clearance (p=0.009) were distinguished. Diplotypes underlying fast and slow metabolizing capacity showed higher and lower BU clearance (ml/min/kg), respectively. GSTA1 diplotypes with slow metabolizing capacity were associated with higher incidence of sinusoidal obstruction syndrome, acute graft versus host disease and combined treatment-related toxicity (p<0.0005). Among other GST genes investigated, GSTP1 313GG correlated with acute graft versus host disease grade 1-4 (p=0.01) and GSTM1 non-null genotype was associated with hemorrhagic cystitis (p=0.003). This study further strengthens the hypothesis that GST diplotypes/genotypes could be incorporated into already existing population pharmacokinetic models for improving first BU dose prediction and HSCT outcomes. (N o Clinicaltrials.gov identifier: NCT01257854. Registered 8 December 2010, retrospectively registered).

GSTA1 diplotypes affect busulfan clearance and toxicity in children undergoing allogeneic hematopoietic stem cell transplantation: a multicenter study

PubMed Central

Ansari, Marc; Curtis, Patricia Huezo-Diaz; Uppugunduri, Chakradhara Rao S.; Rezgui, Mohammed Aziz; Nava, Tiago; Mlakar, Vid; Lesne, Laurence; Théoret, Yves; Chalandon, Yves; Dupuis, Lee L.; Schechter, Tao; Bartelink, Imke H.; Boelens, Jaap J.; Bredius, Robbert; Dalle, Jean-Hugues; Azarnoush, Saba; Sedlacek, Petr; Lewis, Victor; Champagne, Martin; Peters, Christina; Bittencourt, Henrique; Krajinovic, Maja

2017-01-01

Busulfan (BU) dose adjustment following therapeutic drug monitoring contributes to better outcome of hematopoietic stem cell transplantation (HSCT). Further improvement could be achieved through genotype-guided BU dose adjustments. To investigate this aspect, polymorphism within glutathione S transferase genes were assessed. Particularly, promoter haplotypes of the glutathione S transferase A1 (GSTA1) were evaluated in vitro, with reporter gene assays and clinically, in a pediatric multi-center study (N =138) through association with BU pharmacokinetics (PK) and clinical outcomes. Promoter activity significantly differed between the GSTA1 haplotypes (p<0.001) supporting their importance in capturing PK variability. Four GSTA1 diplotype groups that significantly correlated with clearance (p=0.009) were distinguished. Diplotypes underlying fast and slow metabolizing capacity showed higher and lower BU clearance (ml/min/kg), respectively. GSTA1 diplotypes with slow metabolizing capacity were associated with higher incidence of sinusoidal obstruction syndrome, acute graft versus host disease and combined treatment-related toxicity (p<0.0005). Among other GST genes investigated, GSTP1 313GG correlated with acute graft versus host disease grade 1-4 (p=0.01) and GSTM1 non-null genotype was associated with hemorrhagic cystitis (p=0.003). This study further strengthens the hypothesis that GST diplotypes/genotypes could be incorporated into already existing population pharmacokinetic models for improving first BU dose prediction and HSCT outcomes. (No Clinicaltrials.gov identifier: NCT01257854. Registered 8 December 2010, retrospectively registered). PMID:29207608

Possible risk factors associated with greater damage in systemic lupus erythematosus patients: an Egyptian multicenter study.

PubMed

Hammad, M; Eissa, M; Fathi, S

2016-08-01

Systemic lupus erythematosus (SLE) is a prototypic multisystem autoimmune disorder. The total damage in a patient with SLE may result from SLE itself or from any other pathologic process. The aim of this study was to assess risk factors of greater damage in a sample of Egyptian SLE patients. This Egyptian multicenter retrospective study included 100 SLE patients: 64 patients from Cairo University Hospitals and 36 patients from Zagazig University Hospitals. The Systemic Lupus International Collaborative Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (ACR-DI) was used to document the damage in each patient. The total SLICC/ACR-DI score ranged from 0 to 8. A higher DI score was found in hypertensive patients, compared to normotensive patients; and among those with positive anti-phospholipid antibodies, compared to those with negative anti-phospholipid antibodies. This difference was statistically significant (p < 0.01). Also, a higher DI score was found in cyclophosphamide users, compared to non-users; and in those with proteinuria and seizures, compared to those without; and the difference was statistically significant (p < 0.05). There was a significant positive correlation between the DI and patient age (p < 0.05). Damage in SLE cannot be prevented completely, as SLE disease is considered an aggressive disease treated by aggressive medications, but rheumatologists should try to minimize damage as much as possible to maintain the patients' health, functioning and general wellbeing. © The Author(s) 2016.

Prevalence of pilomatricoma in Turner syndrome: findings from a multicenter study.

PubMed

Handler, Marc Z; Derrick, Kristina M; Lutz, Richard E; Morrell, Dean S; Davenport, Marsha L; Armstrong, April W

2013-05-01

The absence of data on the prevalence of pilomatricoma among patients with Turner syndrome served as the catalyst for this multicenter investigation. To ascertain the prevalence of pilomatricoma among patients with Turner syndrome and to determine any association between the development of pilomatricomas and the use of exogenous hormones in patients with Turner syndrome. A retrospective medical record review from January 1, 2000, through January 1, 2010, was performed of all patients with Turner syndrome. Data on pilomatricomas and the use of hormone therapy were collected. University of California-Davis Medical Center, University of Nebraska Medical Center, and The University of North Carolina at Chapel Hill. Patients with a diagnosis of Turner syndrome. Prevalence of concomitant pilomatricoma and diagnosis of Turner syndrome. Secondary outcome measures included the use of the exogenous hormones estrogen or recombinant human growth hormone (rhGH). In total, 311 patients with Turner syndrome were identified from these 3 institutions. Among them, 8 patients (2.6%) were diagnosed as having pilomatricomas. Before the development of pilomatricomas, 5 patients had been treated with rhGH but not estrogen, 1 patient had received estrogen but not rhGH, and 2 patients did not receive either therapy. Although the prevalence of pilomatricoma among the general population is unknown, this study demonstrates a high prevalence (2.6%) of pilomatricomas among patients with Turner syndrome. No apparent relationship was noted among our patients or in the literature between the use of rhGH and the development of pilomatricomas.

A Multicenter Cohort Comparison Study of the Safety, Efficacy, and Cost of Ticagrelor Compared to Clopidogrel in Aneurysm Flow Diverter Procedures.

PubMed

Moore, Justin M; Adeeb, Nimer; Shallwani, Hussain; Gupta, Raghav; Patel, Apar S; Griessenauer, Christoph J; Youn, Roy; Siddiqui, Adnan; Ogilvy, Christopher S; Thomas, Ajith J

2017-10-01

Thromboembolic and hemorrhagic complications are among the most feared adverse events in the endovascular treatment of aneurysms, and this is particularly the case for flow diverter devices. Dual antiplatelet therapy has become standard of care; however, the safety, efficacy, and cost profiles of newer antiplatelet agents are not well characterized in the neurovascular context. To compare the safety, efficacy, and cost of one of these newer agents, ticagrelor, to the most frequently used agent, clopidogrel. A multicenter, retrospective, cohort comparison study design of consecutively treated aneurysms with flow diverter embolization device and treated with either ticagrelor or clopidogrel was performed. Data were collected on patient demographics and risk factors, procedural details, antiplatelet treatment regime, complications, and angiographic and functional outcomes. Fifty patients undergoing flow diverter device deployment and treatment with ticagrelor were compared to 53 patients undergoing flow diversion and treatment with clopidogrel. The patients' age, sex, smoking status, aneurismal morphology and size, and procedural details did not differ between the 2 groups; neither did the rate of thromboembolic and hemorrhagic complications, angiographical, and functional outcomes. Ticagrelor was more expensive when compared to clopidogrel. Ticagrelor is a safe and effective agent for prevention of thromboembolic complications following flow diverter deployment when compared to clopidogrel. However, ticagrelor remains significantly more expensive than clopidogrel, and, thus, we would advise ticagrelor be reserved for patients who are hyporesponsive to clopidogrel. Copyright © 2017 by the Congress of Neurological Surgeons

Early Enteral Nutrition in Burns: Compliance With Guidelines and Associated Outcomes in a Multicenter Study

PubMed Central

Mosier, Michael J.; Pham, Tam N.; Klein, Matthew B.; Gibran, Nicole S.; Arnoldo, Brett D.; Gamelli, Richard L.; Tompkins, Ronald G.; Herndon, David N.

2013-01-01

Early nutritional support is an essential component of burn care to prevent ileus, stress ulceration, and the effects of hypermetabolism. The American Burn Association practice guidelines state that enteral feedings should be initiated as soon as practical. The authors sought to evaluate compliance with early enteral nutrition (EN) guidelines, associated complications, and hospitalization outcomes in a prospective multicenter observational study. They conducted a retrospective review of mechanically ventilated burn patients enrolled in the prospective observational multicenter study “Inflammation and the Host Response to Injury.” Timing of initiation of tube feedings was recorded, with early EN defined as being started within 24 hours of admission. Univariate and multivariate analyses were performed to distinguish barriers to initiation of EN and the impact of early feeding on development of multiple organ dysfunction syndrome, infectious complications, days on mechanical ventilation, intensive care unit (ICU) length of stay, and survival. A total of 153 patients met study inclusion criteria. The cohort comprised 73% men, with a mean age of 41 ± 15 years and a mean %TBSA burn of 46 ± 18%. One hundred twenty-three patients (80%) began EN in the first 24 hours and 145 (95%) by 48 hours. Age, sex, inhalation injury, and full-thickness burn size were similar between those fed by 24 hours vs after 24 hours, except for higher mean Acute Physiology and Chronic Health Evaluation II scores (26 vs 23, P = .03) and smaller total burn size (44 vs 54% TBSA burn, P = .01) in those fed early. There was no significant difference in rates of hyperglycemia, abdominal compartment syndrome, or gastrointestinal bleeding between groups. Patients fed early had shorter ICU length of stay (adjusted hazard ratio 0.57, P = 0.03, 95% confidence interval 0.35–0.94) and reduced wound infection risk (adjusted odds ratio 0.28, P = 0.01, 95% confidence interval 0.10–0.76). The investigators have found early EN to be safe, with no increase in complications and a lower rate of wound infections and shorter ICU length of stay. Across institutions, there has been high compliance with early EN as part of the standard operating procedure in this prospective multicenter observational trial. The investigators advocate that initiation of EN by 24 hours be used as a formal recommendation in nutrition guidelines for severe burns, and that nutrition guidelines be actively disseminated to individual burn centers to permit a change in practice. PMID:21116188

Different patterns of skin manifestations associated with parvovirus B19 primary infection in adults.

PubMed

Mage, Valentia; Lipsker, Dan; Barbarot, Sébastien; Bessis, Didier; Chosidow, Olivier; Del Giudice, Pascal; Aractingi, Sélim; Avouac, Jérôme; Bernier, Claire; Descamps, Vincent; Dupin, Nicolas

2014-07-01

Skin involvement is reported during primary parvovirus B19 infection in adults. We sought to describe the cutaneous presentations associated with parvovirus B19 primary infection in adults. We conducted a descriptive, retrospective, multicenter study. The patients included (>18 years old) had well-established primary infections with parvovirus B19. Twenty-nine patients were identified between 1992 and 2013 (17 women, 12 men). The elementary dermatologic lesions were mostly erythematous (86%) and often purpuric (69%). Pruritus was reported in 48% of cases. The rash predominated on the legs (93%), trunk (55%), and arms (45%), with a lower frequency of facial involvement (20%). Four different but sometimes overlapping patterns were identified (45%): exanthema, which was reticulated and annular in some cases (80%); the gloves-and-socks pattern (24%); the periflexural pattern (28%); and palpable purpura (24%). The limitations of this study were its retrospective design and possible recruitment bias in tertiary care centers. Our findings suggest that primary parvovirus B19 infection is associated with polymorphous skin manifestations with 4 predominant, sometimes overlapping, patterns. The acral or periflexural distribution of the rash and the presence of purpuric or annular/reticulate lesions are highly suggestive of parvovirus B19 infection. Copyright © 2014 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Management of malignant pleural mesothelioma: a French multicenter retrospective study (GFPC 0802 study).

PubMed

Raynaud, C; Greillier, L; Mazieres, J; Monnet, I; Mastroianni, B; Robinet, G; Fraboulet, G; Dixmier, A; Berard, H; Lamy, R; Letreut, J; Lena, H; Oliviero, G; Botta, S; Vergnenegre, A; Borget, I; Chouaid, C

2015-11-06

Malignant pleural mesothelioma (MPM) is a rare disease with poor prognosis in spite of significant improvement in survival, due to new chemotherapy regimens. We describe here patients' profiles and management in daily practice in France. Observational retrospective study. Data were collected from medical files. All patients with histologically proven MPM diagnosed from January 2005 to December 2008 were included in the participating sites. Four hundred and six patients were included in 37 sites: mean age 68.9 ± 9.8 years, male predominance (sex ratio 3.27), latency of the disease 45.7 years, epithelioïd type 83 %. Diagnosis was made using thoracoscopy in 80.8 % of patients. Radical surgery was performed in 6.2 % of cases. Chemotherapy was administered to 74.6 % of patients. First line regimens consisted mainly of platinum + pemetrexed (91 %) or pemetrexed alone (7 %). Objective response rate was 17.2 % and another 41.6 % of patients experienced disease stabilization. Half of these patients underwent second line chemotherapy (platinium + pemetrexed 31.6 %, pemetrexed alone 24.6 %), resulting in a 6 % response rate. Third-line chemotherapy (56 patients) yielded disease control in 5.4 % of cases. The management of MPM in France is usually in accordance with guidelines. Response rates are somewhat lower than those described in clinical trials.

Retrospective multicenter study of leaving the placenta in situ for patients with placenta previa on a cesarean scar.

PubMed

Miyakoshi, Kei; Otani, Toshimitsu; Kondoh, Eiji; Makino, Shintaro; Tanaka, Mamoru; Takeda, Satoru

2018-03-01

To investigate maternal outcomes after leaving the placenta in situ for placenta accreta spectrum (PAS) disorders in patients with placenta previa on a cesarean delivery scar. The present retrospective study reviewed medical records from women with placenta previa on a cesarean scar underwent perinatal care at secondary- or tertiary-level perinatal centers in Japan between January 1, 2010, and December 31, 2014. Perinatal management was conducted based on each leading obstetrician's discretion. The primary outcome was success of the leaving the placenta in situ approach for PAS disorders (defined as preserving the uterus without hysterectomy). Of 178 eligible centers, 126 (71%) participated in this study; data from 613 patients were included. Of these, 41 had the placenta left in situ owing to PAS disorders and follow-up data were available for 36 women. Leaving the placenta in situ was successful in 25 (69%) patients, with placental resorption occurring postpartum (median 89 days; range 6-510). Hysterectomy was performed for 11 patients, primarily owing to hemorrhage and/or infection (median 30 days; range 0-95 days, postpartum). Leaving the placenta in situ, with close postpartum follow-up for at least several months, could be a uterus-preserving option for patient with PAS disorders. © 2017 International Federation of Gynecology and Obstetrics.

Improvement of long-term outcomes in pancreatic cancer and its associated factors within the gemcitabine era: a collaborative retrospective multicenter clinical review of 1,082 patients.

PubMed

Kuroda, Taira; Kumagi, Teru; Yokota, Tomoyuki; Seike, Hirotaka; Nishiyama, Mari; Imai, Yusuke; Inada, Nobu; Shibata, Naozumi; Imamine, Satoshi; Okada, Shin-ichi; Koizumi, Mitsuhito; Yamanishi, Hirofumi; Azemoto, Nobuaki; Miyaike, Jiro; Tanaka, Yoshinori; Tatsukawa, Haruka; Utsunomiya, Hiroki; Ohno, Yoshinori; Miyake, Teruki; Hirooka, Masashi; Furukawa, Shinya; Abe, Masanori; Ikeda, Yoshiou; Matsuura, Bunzo; Hiasa, Yoichi; Onji, Morikazu

2013-08-31

Although the outcomes of pancreatic cancer have been improved by gemcitabine, the changes in its characteristics and long-term outcomes within the gemcitabine era remain unclear. This study was conducted to identify clinical characteristics of pancreatic cancer patients within the gemcitabine era. A retrospective chart review was performed at 10 centers for 1,248 consecutive patients who were ever considered to have a diagnosis of pancreatic cancer between 2001 and 2010. Data collected included demographics, diagnosis date, clinical stage, treatment, and outcome 1,082 patients met the inclusion criteria and were analyzed further. The chi-square test, Student's t-test, and Mann-Whitney U-test were used for statistical analysis. Outcomes were analyzed using the Kaplan-Meier method and Cox proportional hazards regression. Differences in survival analyses were determined using the log-rank test. The distribution of clinical stages was: I, 2.2% II, 3.4% III, 13% IVa, 27% and IVb, 55%. Chemotherapy alone was administered to 42% of patients and 17% underwent resection. The 1-, 3-, and 5-year survival rates were 39%, 13%, and 6.9%, respectively. The median survival time was 257 days, but differed considerably among treatments and clinical stages. Demographics, distribution of clinical stage, and cause of death did not differ between groups A (2001-2005, n=406) and B (2006-2010, n=676). However, group B included more patients who underwent chemotherapy (P<0.0001) and fewer treated with best supportive care (P=0.0004), mirroring improvements in this group's long-term outcomes (P=0.0063). Finally, factors associated with long-term outcomes derived from multivariate analysis were clinical stage (P<0.0001), location of the tumor (P=0.0294) and treatments (surgery, chemotherapy) (<0.0001). Long-term outcomes in pancreatic cancer has improved even within the gemcitabine era, suggesting the importance of offering chemotherapy to patients previously only considered for best supportive care. Most patients are still diagnosed at an advanced stage, making clinical strategy development for diagnosing pancreatic cancer at earlier stages essential.

Retrospective multicenter evaluation of patients diagnosed with mucosal melanoma: a study of Anatolian Society of Medical Oncology.

PubMed

Ercelep, Ozlem; Topcu, Turkan Ozturk; Bayoglu, Ibrahim Vedat; Ekinci, Ahmet Siyar; Koca, Sinan; Kavgaci, Halil; Ozcelik, Melike; Alacacioglu, Ahmet; Uzunoglu, Sernaz; Bozkurt, Oktay; Ulas, Arife; Aksoy, Asude; Taskoylu, Burcu Yapar; Gumussay, Ozge; Yaman, Sebnem; Uysal, Mukremin; Aydin, Dincer; Gumus, Mahmut

2016-09-01

Mucosal melanoma (MM) is a rare type of cancer that differs significantly from cutaneous melanoma. In this study, we aimed to evaluate clinical and demographical characteristics, prognoses and factors influencing survival, treatment alternatives, and features of different subtypes of the patients. The patients were followed up with and treated in different centers due to their diagnoses of MM. We retrospectively analyzed data of 107 patients who were diagnosed with MM in 14 different institutions in Turkey. The mean age of the patients was 64.5 years. Of the patients, 47 % were female and 53 % were male. The median overall survival (OS) was 17 months, and the mean follow-up duration was 27 months. The 2-year survival rate was 42 %, and the 5-year survival rate was 23 %. The best survival rate appeared in those patients with MM in the head-neck region (median survival rate was 27 months, P = 0.034). The most common anatomical site was the head-neck region. In a univariate analysis, variables including age ≥65 years, the anatomical site of the primary lesion other than head and neck region, the metastatic stage of the disease, high levels of lactate dehydrogenase (LDH), and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≥1 were found to be associated with poor survival (P < 0.05). However, in a multivariate analysis, only advanced stage disease (HR = 2.70; 95 % CI, 1.64-4.45; P = 0.000) and high LDH levels (HR = 2.31; 95 % CI, 1.40-3.80; P = 0.001) were determined to be adverse prognostic variables. Primary MM presents a more aggressive behavior and offers a poorer prognosis compared to cutaneous melanoma. Because the disease is rarely seen, is heterogeneous, and lacks randomized studies, issues concerning optimal treatment approaches and management and clinical characteristics of the disease have not been clarified yet.

Improved Long-term Outcomes of Patients With Inflammatory Bowel Disease Receiving Proactive Compared With Reactive Monitoring of Serum Concentrations of Infliximab.

PubMed

Papamichael, Konstantinos; Chachu, Karen A; Vajravelu, Ravy K; Vaughn, Byron P; Ni, Josephine; Osterman, Mark T; Cheifetz, Adam S

2017-10-01

Monitoring serum concentrations of tumor necrosis factor antagonists in patients receiving these drugs as treatment for inflammatory bowel disease (IBD), also called therapeutic drug monitoring, is performed either after patient loss of response (reactive drug monitoring) or in patients in clinical remission in which the drug is titrated to a target concentration (proactive drug monitoring). We compared long-term outcomes of patients with IBD undergoing proactive vs reactive monitoring of serum concentrations of infliximab. We performed a multicenter, retrospective study of 264 consecutive patients with IBD (167 with Crohn's disease) receiving infliximab maintenance therapy. The subjects received proactive (n = 130) or reactive (n = 134) drug monitoring, based on measurements of first infliximab concentration and antibodies to infliximab, from September 2006 to January 2015; they were followed through December 2015 (median time of 2.4 years). We analyzed time to treatment failure, first IBD-related surgery or hospitalization, serious infusion reaction, and detection of antibodies to infliximab. Treatment failure was defined as drug discontinuation for loss of response or serious adverse event, or need for surgery. Multiple Cox regression analysis independently associated proactive drug monitoring, compared with reactive monitoring, with reduced risk for treatment failure (hazard ratio [HR], 0.16; 95% confidence interval [CI], 0.09-0.27; P < .001), IBD-related surgery (HR, 0.30; 95% CI, 0.11-0.80; P = .017), IBD-related hospitalization (HR, 0.16; 95% CI, 0.07-0.33; P < .001), antibodies to infliximab (HR, 0.25; 95% CI, 0.07-0.84; P = .025), and serious infusion reaction (HR, 0.17; 95% CI, 0.04-0.78; P = .023). In a retrospective analysis of patients with IBD receiving proactive vs reactive monitoring of serum concentration of infliximab, proactive monitoring was associated with better clinical outcomes, including greater drug durability, less need for IBD-related surgery or hospitalization, and lower risk of antibodies to infliximab or serious infusion reactions. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Socio-demographic and clinical profiles of paranoid and nonparanoid schizophrenia: a prospective, multicenter study in China.

PubMed

Xiang, Yu-Tao; Wang, Chuan-Yue; Chiu, Helen F K; Weng, Yong-Zhen; Bo, Qi-Jing; Chan, Sandra S M; Lee, Edwin H M; Ungvari, Gabor S

2011-07-01

This study aimed to explore the socio-demographic and clinical characteristics of paranoid and nonparanoid subtypes of schizophrenia. In a multicenter, randomized, controlled, longitudinal study, 374 clinically stable schizophrenia patients were interviewed at entry with standardized assessment instruments and followed for 12-26 months. In the multivariate analysis, male sex, married marital status, urban abode, and more frequent relapse over the study period were independently associated with paranoid schizophrenia. The socio-demographic and clinical characteristics of Chinese patients with the paranoid subtype of schizophrenia are different from those of their Caucasian counterparts who are more likely to be women and have a better outcome. © 2010 Wiley Periodicals, Inc.

Association of prehospitalization aspirin therapy and acute lung injury: results of a multicenter international observational study of at-risk patients.

PubMed

Kor, Daryl J; Erlich, Jason; Gong, Michelle N; Malinchoc, Michael; Carter, Rickey E; Gajic, Ognjen; Talmor, Daniel S

2011-11-01

To evaluate the association between prehospitalization aspirin therapy and incident acute lung injury in a heterogeneous cohort of at-risk medical patients. This is a secondary analysis of a prospective multicenter international cohort investigation. Multicenter observational study including 20 US hospitals and two hospitals in Turkey. Consecutive, adult, nonsurgical patients admitted to the hospital with at least one major risk factor for acute lung injury. None. Baseline characteristics and acute lung injury risk factors/modifiers were identified. The presence of aspirin therapy and the propensity to receive this therapy were determined. The primary outcome was acute lung injury during hospitalization. Secondary outcomes included intensive care unit and hospital mortality and intensive care unit and hospital length of stay. Twenty-two hospitals enrolled 3855 at-risk patients over a 6-month period. Nine hundred seventy-six (25.3%) were receiving aspirin at the time of hospitalization. Two hundred forty (6.2%) patients developed acute lung injury. Univariate analysis noted a reduced incidence of acute lung injury in those receiving aspirin therapy (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.46-0.90; p = .010). This association was attenuated in a stratified analysis based on deciles of aspirin propensity scores (Cochran-Mantel-Haenszel pooled OR, 0.70; 95% CI, 0.48-1.03; p = .072). After adjusting for the propensity to receive aspirin therapy, no statistically significant associations between prehospitalization aspirin therapy and acute lung injury were identified; however, a prospective clinical trial to further evaluate this association appears warranted.

Infant lung function tests as endpoints in the ISIS multicenter clinical trial in cystic fibrosis.

PubMed

Davis, Stephanie D; Ratjen, Felix; Brumback, Lyndia C; Johnson, Robin C; Filbrun, Amy G; Kerby, Gwendolyn S; Panitch, Howard B; Donaldson, Scott H; Rosenfeld, Margaret

2016-05-01

The Infant Study of Inhaled Saline (ISIS) in CF was the first multicenter clinical trial to utilize infant pulmonary function tests (iPFTs) as an endpoint. Secondary analysis of ISIS data was conducted in order to assess feasibility of iPFT measures and their associations with respiratory symptoms. Standard deviations were calculated to aid in power calculations for future clinical trials. Seventy-three participants enrolled, 70 returned for the final visit; 62 (89%) and 45 (64%) had acceptable paired functional residual capacity (FRC) and raised volume measurements, respectively. Mean baseline FEV0.5, FEF75 and FRC z-scores were 0.3 (SD: 1.2), -0.2 (SD: 2.0), and 1.8 (SD: 2.0). iPFTs are not appropriate primary endpoints for multicenter clinical trials due to challenges of obtaining acceptable data and near-normal average raised volume measurements. Raised volume measures have potential to serve as secondary endpoints in future clinical CF trials. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

The Association Between Nutritional Adequacy and Long-Term Outcomes in Critically Ill Patients Requiring Prolonged Mechanical Ventilation: A Multicenter Cohort Study.

PubMed

Wei, Xuejiao; Day, Andrew G; Ouellette-Kuntz, Hélène; Heyland, Daren K

2015-08-01

To examine the association between short-term nutritional adequacy received while in the ICU and long-term outcomes including 6-month survival and health-related quality of life in critically ill patients requiring prolonged mechanical ventilation. Retrospective analysis of data prospectively collected in the context of a multicenter randomized controlled trial. An international sample of ICUs. Adult patients who were mechanically ventilated for more than 8 days in the ICU. None. Nutritional adequacy was obtained from the average proportion of prescribed calories received over the amount prescribed during the first 8 days. Survival status and health-related quality of life as assessed using the Short-Form 36 v2 were obtained at 3- and 6 months post ICU admission. Of the 1,223 patients enrolled in the randomized controlled trial, 475 met the inclusion criteria for this study. At 6-month follow-up, 302 of the 475 patients (64%) were alive. Survival time in those who received low nutritional adequacy was significantly shorter than those who received high nutritional adequacy while adjusting for important covariates (adjusted hazard ratio, 1.7; 95% CI, 1.1-2.6). At 3-month follow-up, a 25% increase in nutritional adequacy was associated with improvements in Physical Functioning and Role Physical of 7.3 (p = 0.02) and 8.3 (p = 0.004) points, respectively. At 6-month follow-up, adjusted increases in Physical Functioning and Role Physical scores for every 25% increase in nutrition adequacy became smaller and were no longer statistically significant (adjusted estimate for Physical Functioning = 4.2, p = 0.14; for Role Physical = 3.2, p = 0.25). Greater amounts of nutritional intake received during the first week in the ICU were associated with longer survival time and faster physical recovery to 3 months but not 6 months post ICU discharge in critically ill patients requiring prolonged mechanical ventilation. Current recommendations to underfeed critically ill patients may cause harm in some long-stay patients.

Optimal sequencing of ibrutinib, idelalisib, and venetoclax in chronic lymphocytic leukemia: results from a multicenter study of 683 patients.

PubMed

Mato, A R; Hill, B T; Lamanna, N; Barr, P M; Ujjani, C S; Brander, D M; Howlett, C; Skarbnik, A P; Cheson, B D; Zent, C S; Pu, J J; Kiselev, P; Foon, K; Lenhart, J; Henick Bachow, S; Winter, A M; Cruz, A-L; Claxton, D F; Goy, A; Daniel, C; Isaac, K; Kennard, K H; Timlin, C; Fanning, M; Gashonia, L; Yacur, M; Svoboda, J; Schuster, S J; Nabhan, C

2017-05-01

Ibrutinib, idelalisib, and venetoclax are approved for treating CLL patients in the United States. However, there is no guidance as to their optimal sequence. We conducted a multicenter, retrospective analysis of CLL patients treated with kinase inhibitors (KIs) or venetoclax. We examined demographics, discontinuation reasons, overall response rates (ORR), survival, and post-KI salvage strategies. Primary endpoint was progression-free survival (PFS). A total of 683 patients were identified. Baseline characteristics were similar in the ibrutinib and idelalisib groups. ORR to ibrutinib and idelalisib as first KI was 69% and 81%, respectively. With a median follow-up of 17 months (range 1-60), median PFS and OS for the entire cohort were 35 months and not reached. Patients treated with ibrutinib (versus idelalisib) as first KI had a significantly better PFS in all settings; front-line [hazard ratios (HR) 2.8, CI 1.3-6.3, P = 0.01], relapsed-refractory (HR 2.8, CI 1.9-4.1, P < 0.001), del17p (HR 2.0, CI 1.2-3.4, P = 0.008), and complex karyotype (HR 2.5, CI 1.2-5.2, P = 0.02). At the time of initial KI failure, use of an alternate KI or venetoclax had a superior PFS when compared with chemoimmunotherapy. Furthermore, patients who discontinued ibrutinib due to progression or toxicity had marginally improved outcomes if they received venetoclax (ORR 79%) versus idelalisib (ORR 46%) (PFS HR .6, CI.3-1.0, P = 0.06). In the largest real-world experience of novel agents in CLL, ibrutinib appears superior to idelalisib as first KI. Furthermore, in the setting of KI failure, alternate KI or venetoclax therapy appear superior to chemoimmunotherapy combinations. The use of venetoclax upon ibrutinib failure might be superior to idelalisib. These data support the need for trials testing sequencing strategies to optimize treatment algorithms. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Shared decision-making in end-stage renal disease: a protocol for a multi-center study of a communication intervention to improve end-of-life care for dialysis patients.

PubMed

Eneanya, Nwamaka D; Goff, Sarah L; Martinez, Talaya; Gutierrez, Natalie; Klingensmith, Jamie; Griffith, John L; Garvey, Casey; Kitsen, Jenny; Germain, Michael J; Marr, Lisa; Berzoff, Joan; Unruh, Mark; Cohen, Lewis M

2015-06-12

End-stage renal disease carries a prognosis similar to cancer yet only 20 % of end-stage renal disease patients are referred to hospice. Furthermore, conversations between dialysis team members and patients about end-of-life planning are uncommon. Lack of provider training about how to communicate prognostic data may contribute to the limited number of end-of-life care discussions that take place with this chronically ill population. In this study, we will test the Shared Decision-Making Renal Supportive Care communication intervention to systematically elicit patient and caretaker preferences for end-of-life care so that care concordant with patients' goals can be provided. This multi-center study will deploy an intervention to improve end-of-life communication for hemodialysis patients who are at high risk of death in the ensuing six months. The intervention will be carried out as a prospective cohort with a retrospective cohort serving as the comparison group. Patients will be recruited from 16 dialysis units associated with two large academic centers in Springfield, Massachusetts and Albuquerque, New Mexico. Critical input from patient advisory boards, a stakeholder panel, and initial qualitative analysis of patient and caretaker experiences with advance care planning have informed the communication intervention. Rigorous communication training for hemodialysis social workers and providers will ensure that standardized study procedures are performed at each dialysis unit. Nephrologists and social workers will communicate prognosis and provide advance care planning in face-to-face encounters with patients and families using a social work-centered algorithm. Study outcomes including frequency and timing of hospice referrals, patient and caretaker satisfaction, quality of end-of-life discussions, and quality of death will be assessed over an 18 month period. The Shared Decision-Making Renal Supportive Care Communication intervention intends to improve discussions about prognosis and end-of-life care with end-stage renal disease patients. We anticipate that the intervention will help guide hemodialysis staff and providers to effectively participate in advance care planning for patients and caretakers to establish preferences and goals at the end of life. NCT02405312.

Survival in HIV-infected patients after a cancer diagnosis in the cART Era: results of an italian multicenter study.

PubMed

Gotti, Daria; Raffetti, Elena; Albini, Laura; Sighinolfi, Laura; Maggiolo, Franco; Di Filippo, Elisa; Ladisa, Nicoletta; Angarano, Gioacchino; Lapadula, Giuseppe; Pan, Angelo; Esposti, Anna Degli; Fabbiani, Massimiliano; Focà, Emanuele; Scalzini, Alfredo; Donato, Francesco; Quiros-Roldan, Eugenia

2014-01-01

We studied survival and associated risk factors in an Italian nationwide cohort of HIV-infected individuals after an AIDS-defining cancer (ADC) or non-AIDS-defining cancer (NADC) diagnosis in the modern cART era. Multi-center, retrospective, observational study of HIV patients included in the MASTER Italian Cohort with a cancer diagnosis from January 1998 to September 2012. Malignancies were divided into ADC or NADC on the basis of the Centre for Disease Control-1993 classification. Recurrence of cancer and metastases were excluded. Survivals were estimated according to the Kaplan-Meier method and compared according to the log-rank test. Statistically significant variables at univariate analysis were entered in a multivariate Cox regression model. Eight hundred and sixty-six cancer diagnoses were recorded among 13,388 subjects in the MASTER Database after 1998: 435 (51%) were ADCs and 431 (49%) were NADCs. Survival was more favorable after an ADC diagnosis than a NADC diagnosis (10-year survival: 62.7%±2.9% vs. 46%±4.2%; p = 0.017). Non-Hodgkin lymphoma had lower survival rates than patients with Kaposi sarcoma or cervical cancer (10-year survival: 48.2%±4.3% vs. 72.8%±4.0% vs. 78.5%±9.9%; p<0.001). Regarding NADCs, breast cancer showed better survival (10-year survival: 65.1%±14%) than lung cancer (1-year survival: 28%±8.7%), liver cancer (5-year survival: 31.9%±6.4%) or Hodgkin lymphoma (10-year survival: 24.8%±11.2%). Lower CD4+ count and intravenous drug use were significantly associated with decreased survival after ADCs or NADCs diagnosis. Exposure to cART was found to be associated with prolonged survival only in the case of ADCs. cART has improved survival in patients with an ADC diagnosis, whereas the prognosis after a diagnosis of NADCs is poor. Low CD4+ counts and intravenous drug use are risk factors for survival following a diagnosis of ADCs and Hodgkin lymphoma in the NADC group.

Multicenter study of subjective acceptance during magnetic resonance imaging at 7 and 9.4 T.

PubMed

Rauschenberg, Jaane; Nagel, Armin M; Ladd, Susanne C; Theysohn, Jens M; Ladd, Mark E; Möller, Harald E; Trampel, Robert; Turner, Robert; Pohmann, Rolf; Scheffler, Klaus; Brechmann, André; Stadler, Jörg; Felder, Jörg; Shah, N Jon; Semmler, Wolfhard

2014-05-01

The aims of this study were to investigate the subjective discomfort and sensory side effects during ultrahigh field (UHF) magnetic resonance imaging (MRI) examinations in a large-scale study and to evaluate differences between magnetic resonance (MR) sites. Four MR sites with a 7-T MR system and 2 MR sites with a 9.4-T MR system participated in this multicenter study with a total number of 3457 completed questionnaires on causes of discomfort and sensations during the examination. For a pooled retrospective analysis of the results from the partially different questionnaires, all data were adapted to an answer option with a 4-point scale (0 = no discomfort/side effect, 3 = very unpleasant/very strong sensation). To differentiate effects evoked by the low-frequency time-varying magnetic fields due to movement through the static magnetic field, most questionnaires separated the manifestation of sensory side effects during movement on the patient table from manifestation while lying still in the isocenter. In general, a high acceptance of UHF examinations was found, where in 82% of the completed questionnaires, the subjects stated the examination to be at least tolerable. Although in 7.6% of the questionnaires, subjects felt discomfort during the examination, only 0.9% of the image acquisitions had to be terminated prematurely. No adverse events occurred in any of the examinations. Only 1% of the subjects were unwilling to undergo further UHF MRI examinations. Examination duration was the most complained cause of discomfort, followed by acoustic noise and lying still. All magnetic-field-related sensations were more pronounced when moving the patient table versus the isocenter position (19%/2% of the subjects felt unpleasant vertigo during the moving/stationary state). In general, vertigo was the most often stated sensory side effect and was more pronounced at 9.4 T compared with 7 T. However, the results varied substantially among the different sites. The high levels of subjective acceptance found in this study lead to the conclusion that UHF MRI would be tolerated as a diagnostic tool in clinical practice. For more consistent data ascertainment, we propose a standardized questionnaire for subjective perception monitoring.

Proposed clinical pathway for nonoperative management of high-grade pediatric pancreatic injuries based on a multicenter analysis: A pediatric trauma society collaborative.

PubMed

Naik-Mathuria, Bindi J; Rosenfeld, Eric H; Gosain, Ankush; Burd, Randall; Falcone, Richard A; Thakkar, Rajan; Gaines, Barbara; Mooney, David; Escobar, Mauricio; Jafri, Mubeen; Stallion, Anthony; Klinkner, Denise B; Russell, Robert; Campbell, Brendan; Burke, Rita V; Upperman, Jeffrey; Juang, David; St Peter, Shawn; Fenton, Stephon J; Beaudin, Marianne; Wills, Hale; Vogel, Adam; Polites, Stephanie; Pattyn, Adam; Leeper, Christine; Veras, Laura V; Maizlin, Ilan; Thaker, Shefali; Smith, Alexis; Waddell, Megan; Drews, Joseph; Gilmore, James; Armstrong, Lindsey; Sandler, Alexis; Moody, Suzanne; Behrens, Brandon; Carmant, Laurence

2017-10-01

Guidelines for nonoperative management (NOM) of high-grade pancreatic injuries in children have not been established, and wide practice variability exists. The purpose of this study was to evaluate common clinical strategies across multiple pediatric trauma centers to develop a consensus-based standard clinical pathway. A multicenter, retrospective review was conducted of children with high-grade (American Association of Surgeons for Trauma grade III-V) pancreatic injuries treated with NOM between 2010 and 2015. Data were collected on demographics, clinical management, and outcomes. Eighty-six patients were treated at 20 pediatric trauma centers. Median age was 9 years (range, 1-18 years). The majority (73%) of injuries were American Association of Surgeons for Trauma grade III, 24% were grade IV, and 3% were grade V. Median time from injury to presentation was 12 hours and median ISS was 16 (range, 4-66). All patients had computed tomography scan and serum pancreatic enzyme levels at presentation, but serial enzyme level monitoring was variable. Pancreatic enzyme levels did not correlate with injury grade or pseudocyst development. Parenteral nutrition was used in 68% and jejunal feeds in 31%. 3Endoscopic retrograde cholangiopancreatogram was obtained in 25%. An organized peripancreatic fluid collection present for at least 7 days after injury was identified in 59% (42 of 71). Initial management of these included: observation 64%, percutaneous drain 24%, and endoscopic drainage 10% and needle aspiration 2%. Clear liquids were started at a median of 6 days (IQR, 3-13 days) and regular diet at a median of 8 days (IQR 4-20 days). Median hospitalization length was 13 days (IQR, 7-24 days). Injury grade did not account for prolonged time to initiating oral diet or hospital length; indicating that the variability in these outcomes was largely due to different surgeon preferences. High-grade pancreatic injuries in children are rare and significant variability exists in NOM strategies, which may affect outcomes and effective resource utilization. A standard clinical pathway is proposed. Therapeutic/care management, level V (case series).

Survival in HIV-Infected Patients after a Cancer Diagnosis in the cART Era: Results of an Italian Multicenter Study

PubMed Central

Gotti, Daria; Raffetti, Elena; Albini, Laura; Sighinolfi, Laura; Maggiolo, Franco; Di Filippo, Elisa; Ladisa, Nicoletta; Angarano, Gioacchino; Lapadula, Giuseppe; Pan, Angelo; Esposti, Anna Degli; Fabbiani, Massimiliano; Focà, Emanuele; Scalzini, Alfredo; Donato, Francesco; Quiros-Roldan, Eugenia

2014-01-01

Objectives We studied survival and associated risk factors in an Italian nationwide cohort of HIV-infected individuals after an AIDS-defining cancer (ADC) or non-AIDS-defining cancer (NADC) diagnosis in the modern cART era. Methods Multi-center, retrospective, observational study of HIV patients included in the MASTER Italian Cohort with a cancer diagnosis from January 1998 to September 2012. Malignancies were divided into ADC or NADC on the basis of the Centre for Disease Control-1993 classification. Recurrence of cancer and metastases were excluded. Survivals were estimated according to the Kaplan-Meier method and compared according to the log-rank test. Statistically significant variables at univariate analysis were entered in a multivariate Cox regression model. Results Eight hundred and sixty-six cancer diagnoses were recorded among 13,388 subjects in the MASTER Database after 1998: 435 (51%) were ADCs and 431 (49%) were NADCs. Survival was more favorable after an ADC diagnosis than a NADC diagnosis (10-year survival: 62.7%±2.9% vs. 46%±4.2%; p = 0.017). Non-Hodgkin lymphoma had lower survival rates than patients with Kaposi sarcoma or cervical cancer (10-year survival: 48.2%±4.3% vs. 72.8%±4.0% vs. 78.5%±9.9%; p<0.001). Regarding NADCs, breast cancer showed better survival (10-year survival: 65.1%±14%) than lung cancer (1-year survival: 28%±8.7%), liver cancer (5-year survival: 31.9%±6.4%) or Hodgkin lymphoma (10-year survival: 24.8%±11.2%). Lower CD4+ count and intravenous drug use were significantly associated with decreased survival after ADCs or NADCs diagnosis. Exposure to cART was found to be associated with prolonged survival only in the case of ADCs. Conclusions cART has improved survival in patients with an ADC diagnosis, whereas the prognosis after a diagnosis of NADCs is poor. Low CD4+ counts and intravenous drug use are risk factors for survival following a diagnosis of ADCs and Hodgkin lymphoma in the NADC group. PMID:24760049

The prognosis of infective endocarditis treated with biological valves versus mechanical valves: A meta-analysis.

PubMed

Tao, Ende; Wan, Li; Wang, WenJun; Luo, YunLong; Zeng, JinFu; Wu, Xia

2017-01-01

Surgery remains the primary form of treatment for infective endocarditis (IE). However, it is not clear what type of prosthetic valve provides a better prognosis. We conducted a meta-analysis to compare the prognosis of infective endocarditis treated with biological valves to cases treated with mechanical valves. Pubmed, Embase and Cochrane databases were searched from January 1960 to November 2016.Randomized controlled trials, retrospective cohorts and prospective studies comparing outcomes between biological valve and mechanical valve management for infective endocarditis were analyzed. The Newcastle-Ottawa Scale(NOS) was used to evaluate the quality of the literature and extracted data, and Stata 12.0 software was used for the meta-analysis. A total of 11 publications were included; 10,754 cases were selected, involving 6776 cases of biological valves and 3,978 cases of mechanical valves. The all-cause mortality risk of the biological valve group was higher than that of the mechanical valve group (HR = 1.22, 95% CI 1.03 to 1.44, P = 0.023), as was early mortality (RR = 1.21, 95% CI 1.02 to 1.43, P = 0.033). The recurrence of endocarditis (HR = 1.75, 95% CI 1.26 to 2.42, P = 0.001), as well as the risk of reoperation (HR = 1.79, 95% CI 1.15 to 2.80, P = 0.010) were more likely to occur in the biological valve group. The incidence of postoperative embolism was less in the biological valve group than in the mechanical valve group, but this difference was not statistically significant (RR = 0.90, 95% CI 0.76 to 1.07, P = 0.245). For patients with prosthetic valve endocarditis (PVE), there was no significant difference in survival rates between the biological valve group and the mechanical valve group (HR = 0.91, 95% CI 0.68 to 1.21, P = 0.520). The results of our meta-analysis suggest that mechanical valves can provide a significantly better prognosis in patients with infective endocarditis. There were significant differences in the clinical features of patients receiving a biological valve compared to patients receiving a mechanical valve. A large, multicenter retrospective study included in our meta-analysis suggested that any mortality risk of the biological valve group was significant higher than that of the mechanical valve group. However, the risk was no different after risk was adjusted. So, we thought the reason for this result may be related to the characteristics of the patient rather than valve dysfunction. It is still necessary to future randomized studies to verify this conclusion.

The pediatric heart network: meeting the challenges to multicenter studies in pediatric heart disease

PubMed Central

Burns, Kristin M.; Pemberton, Victoria L.; Pearson, Gail D.

2017-01-01

Purpose of review Because of the relatively small numbers of pediatric patients with congenital heart disease cared for in any individual center, there is a significant need for multicenter clinical studies to validate new medical or surgical therapies. The Pediatric Heart Network (PHN), with 15 years of experience in multicenter clinical research, has tackled numerous challenges when conducting multicenter studies. Recent findings This review describes the challenges encountered and the strategies employed to conduct high-quality, collaborative research in pediatric cardiovascular disease. Summary Sharing lessons learned from the PHN can provide guidance to investigators interested in conducting pediatric multicenter studies. PMID:26196261

A novel scoring system based on common laboratory tests predicts the efficacy of TNF-inhibitor and IL-6 targeted therapy in patients with rheumatoid arthritis: a retrospective, multicenter observational study.

PubMed

Nakagawa, Jin; Koyama, Yoshinobu; Kawakami, Atsushi; Ueki, Yukitaka; Tsukamoto, Hiroshi; Horiuchi, Takahiko; Nagano, Shuji; Uchino, Ayumi; Ota, Toshiyuki; Akahoshi, Mitsuteru; Akashi, Koichi

2017-08-11

Currently, although several categories of biological disease-modifying antirheumatic drugs (bDMARDs) are available, there are few data informing selection of initial treatment for individual patients with rheumatoid arthritis (RA). Therefore, tumor necrosis factor inhibitor (TNF-i) and tocilizumab (TCZ) are treated as equivalent treatments in the recent disease management recommendations. We focused on two anticytokine therapies, TCZ and TNF-i, and aimed to develop a scoring system that predicts a better treatment for each RA patient before starting an IL-6 or a TNF-i. The expression of IL-6 and TNF-α mRNA in peripheral blood from 45 newly diagnosed RA patients was measured by DNA microarrays to evaluate cytokine activation. Next, laboratory indices immediately before commencing treatment and disease activity score improvement ratio after 6 months in 98 patients treated with TCZ or TNF-i were retrospectively analyzed. Some indices correlated with TCZ efficacy were selected and their cutoff values were defined by receiver operating characteristic (ROC) analysis to develop a scoring system to discriminate between individuals more likely to respond to TCZ or TNF-i. The validity of the scoring system was verified in these 98 patients and an additional 228 patients. There was significant inverse correlation between the expression of IL-6 and TNF-α mRNA in newly diagnosed RA patients. The analysis of 98 patients revealed significant correlation between TCZ efficacy and platelet counts, hemoglobin, aspartate aminotransferase, and alanine aminotransferase; in contrast, there was no similar correlation in the TNF-i group. The cutoff values were defined by ROC analysis to develop a scoring system (1 point/item, maximum of 4 points). A good TCZ response was predicted if the score was ≥2; in contrast, TNF-i seemed to be preferable if the score was ≤1. Similar results were obtained in a validation study of an additional 228 patients. If the case scored ≥3, the good responder rates of TCZ/TNF-i were 75.0%/37.9% (p < 0.01) and the non-responder rates were 3.1%/27.6% (p < 0.01), respectively. The score is easily calculated from common laboratory results. It appears useful for identifying a better treatment at the time of selecting either an IL-6 or a TNF inhibitor.

A New Harmonized Approach to Estimate Busulfan Exposure Predicts Survival and Toxicity after Hematopoietic Cell Transplantation in Children and Young Adults: a Multicenter Retrospective Cohort Analysis

PubMed Central

Bartelink, I.H.; Lalmohamed, Arief; van Reij, Elisabeth M.L.; Dvorak, Chris C.; Savic, Rada M.; Zwaveling, Juliette; Bredius, Robbert. G.M.; Egberts, Antoine C.G.; Bierings, M.; Kletzel, M.; Shaw, Peter J.; Nath, Christa E.; Hempel, George; Ansari, M.; Krajinovic, M.; Theoret, Yves; Duval, Michel; Keizer, Ron J.; Bittencourt, Henriette; Hassan, Moustapha; Güngör, Tayfun; Wynn, Robert F.; Veys, Paul; Cuvelier, Geoff D.E.; Marktel, Sarah; Chiesa, Robert; Cowan, Morton J.; Slatter, Mary A.; Stricherz, Melisa K.; Jennissen, Cathryn; Long-Boyle, Janel R.; Boelens, Jaap Jan

2016-01-01

Background Intravenous-busulfan (IV-busulfan) combined with therapeutic drug monitoring to guide dosing improves outcomes after allogeneic hematopoietic cell transplantation (allo-HCT). The best method to estimate busulfan exposure and the optimal exposure in children/young adults remains unclear. We therefore evaluated three approaches to estimate IV-Bu exposure (expressed as cumulative-area-under-the-curve; AUC) and associated busulfan-AUC with clinical outcomes in children/young adults undergoing allo-HCT. Methods In this retrospective analysis, patients (0.1–30.4 years) receiving busulfan-based conditioning regimen from 15 centers were included. Cumulative AUC was calculated by numerical integration using non-linear mixed effect modeling (AUCNONMEM), non-compartmental analysis (AUC0-infinity and AUC to the end of the dose interval AUC0-tau) and by individual centers using a variety of approaches (AUCcenter). Main outcome of interest was event-free survival (EFS). Other outcomes of interest were overall survival, graft-failure, relapse, transplantation related mortality (TRM), acute toxicity (veno-occlusive disease (VOD) and/or acute graft versus-host disease (aGvHD), chronic GvHD (cGvHD) and cGVHD-free event-free survival (GEFS). Propensity score adjusted cox proportional hazard models, Weibull models, and Fine-Gray competing risk regressions were used. Results 674 patients were included (41% malignant, 59% non-malignant) Estimated 2-year EFS was 69.7%. The median busulfan AUCNONMEM was 74.4 mg*h/L (CI95% 31.1–104.6 mg*h/L). The median AUCNONMEM correlated poorly with AUCcenter (R2 = 0.254). Patients with optimal IV-busulfan AUC of 78–101 mg*h/L showed 81% EFS at 2 years compared to 66.1% and 49.5% in the low (<78 mg*h/L) and high (>101 mg*h/L) busulfan AUC group respectively (P=0.011). Graft-failure/relapse occurred more frequently in the low AUC group (HR=1.75 P<0.001). Acute toxicity, cGvHD and TRM was significantly higher in the high AUC group (HR 1.69, 2.99 and 1.30), independent of indication. Interpretation These results demonstrate that improved clinical outcomes may be achieved by targeting the busulfan-AUC to 78–101 mg*h/L using a new validated pharmacokinetic-model for all indications. PMID:27746112

Management of small cell carcinoma of esophagus in China.

PubMed

Lu, Xu-jing; Luo, Ju-dong; Ling, Yang; Kong, Ying-Ze; Feng, Li-Li; Zhou, Jian; Wang, Feng

2013-07-01

Small cell carcinoma of esophagus (SCEC) is characterized by high malignancy and early metastasis. Although the morbidity of SCEC is very low, few studies of patients with SCEC have been conducted in China, there are no sufficient studies of SCEC conducted and reported in the existing published works, and the choices of treatment remain controversial. In this work, we aim to study the clinical characteristics of SCEC, and explore the corresponding treatment and prognosis through retrospective analysis. The original articles were identified through the leading digital libraries in China in which the terms "esophagus or esophageal" and "small cell esophageal carcinoma" appeared from 2005 to 2009, 1,176 eligible cases were reviewed for clinical data. Analysis of survival was conducted using the Kaplan-Meier method, and differences were compared using the log-rank test. One thousand one hundred seventy-six eligible cases were analyzed; the median age of patients was 57 years, with a male-to-female ratio of 2.4:1. The number of SCEC accounted for 1.26 % of esophageal cancer treated in the same period. Of the tumors, 89.7 % were located in mid- and lower thoracic esophagus. The average tumor length was 5.4 cm (0.5-17 cm). The median overall survival was 11.1 months for all patients. The 1-, 2-, 3-, and 5-year average overall survival rates of 469 patients was 51.1, 25.5, 13.2, 7.9 %, respectively. The median survival time for LD patients who received systemic treatment was 16.8 m, whereas for those who received local treatment (surgery), the median survival time was 10.1 m; the median survival time for ED patients who received systemic treatment was 7.4 m, compared with 5.8 m for those who received sole treatment (chemotherapy or radiotherapy). SCEC is a tumor characterized by high malignancy and early metastasis. Although our retrospective analysis cannot provide definitive conclusions on the optimal treatment modality for SCEC, however, our results suggest that systemic treatment combined with surgical resection plays a major role in the therapy of SCEC, systemic therapy may be an effective approach for the treatment of SCEC, and randomized, prospective, multicenter studies are needed to identify optimal treatment modalities for SCEC.

Lumen-apposing covered self-expandable metal stents for short benign gastrointestinal strictures: a multicenter study.

PubMed

Yang, Dennis; Nieto, Jose M; Siddiqui, Ali; Riff, Brian P; DiMaio, Christopher J; Nagula, Satish; Ismail, Amr M; Ngamreungphong, Saowanee; Khashab, Mouen A; Wagh, Mihir S; Tzimas, Demetrios; Buscaglia, Jonathan M; Strand, Daniel S; Wang, Andrew Y; Chauhan, Shailendra S; Forsmark, Christopher E; Draganov, Peter V

2017-04-01

Background and study aim  Use of the fully covered self-expandable metal stent (SEMS) for benign luminal gastrointestinal (GI) stricture (BLGS) has been limited by the migration rate. The role of the lumen-apposing metal stent (LAMS) for BLGS is not well defined. We assessed the safety, feasibility, and efficacy of LAMS for the treatment of BLGS. Patients and methods  This was an observational, open-label, retrospective, single-arm, multicenter consecutive case series of patients undergoing LAMS placement for BLGS. Technical success was defined as successful placement of the LAMS. Short- and long-term clinical success rates were defined as symptom improvement/resolution with indwelling stent and after stent removal, respectively. All adverse events and additional interventions were recorded. Results  A total of 30 patients (mean age 51.6 years; 63.3 % women) underwent LAMS placement for GI strictures (83.9 % anastomotic). Median stricture diameter and length were 4.5 mm (range 2 - 10 mm) and 8 mm (range 5 - 10 mm), respectively. Technical success was achieved in 29 patients (96.7 %), with an adverse event rate of 13.3 %. The stent migration rate was 8.0 % (2/25) on follow-up endoscopy. Short-term clinical success was achieved in 90.0 % (27/30) at a median of 60 days (interquartile range [IQR] 40 - 90 days). Most patients (19/23; 82.6 %) experienced sustained symptom improvement/resolution without the need for additional interventions at a median follow-up of 100 days (IQR 60 - 139 days) after LAMS removal. Conclusion  This multicenter study demonstrated that LAMS placement represents a safe, feasible, and effective therapeutic option for patients with BLGS and is associated with a low stent migration rate. Our initial findings suggest that future prospective comparative studies are needed on the use of LAMS, endoscopic dilation, and conventional SEMS. . © Georg Thieme Verlag KG Stuttgart · New York.

Multicenter review of diaphragm pacing in spinal cord injury: successful not only in weaning from ventilators but also in bridging to independent respiration.

PubMed

Posluszny, Joseph A; Onders, Raymond; Kerwin, Andrew J; Weinstein, Michael S; Stein, Deborah M; Knight, Jennifer; Lottenberg, Lawrence; Cheatham, Michael L; Khansarinia, Saeid; Dayal, Saraswati; Byers, Patricia M; Diebel, Lawrence

2014-02-01

Ventilator-dependent spinal cord-injured (SCI) patients require significant resources related to ventilator dependence. Diaphragm pacing (DP) has been shown to successfully replace mechanical ventilators for chronic ventilator-dependent tetraplegics. Early use of DP following SCI has not been described. Here, we report our multicenter review experience with the use of DP in the initial hospitalization after SCI. Under institutional review board approval for humanitarian use device, we retrospectively reviewed our multicenter nonrandomized interventional protocol of laparoscopic diaphragm motor point mapping with electrode implantation and subsequent diaphragm conditioning and ventilator weaning. Twenty-nine patients with an average age of 31 years (range, 17-65 years) with only two females were identified. Mechanism of injury included motor vehicle collision (7), diving (6), gunshot wounds (4), falls (4), athletic injuries (3), bicycle collision (2), heavy object falling on spine (2), and motorcycle collision (1). Elapsed time from injury to surgery was 40 days (range, 3-112 days). Seven (24%) of the 29 patients who were evaluated for the DP placement had nonstimulatable diaphragms from either phrenic nerve damage or infarction of the involved phrenic motor neurons and were not implanted. Of the stimulatable patients undergoing DP, 72% (16 of 22) were completely free of ventilator support in an average of 10.2 days. For the remaining six DP patients, two had delayed weans of 180 days, three had partial weans using DP at times during the day, and one patient successfully implanted went to a long-term acute care hospital and subsequently had life-prolonging measures withdrawn. Eight patients (36%) had complete recovery of respiration, and DP wires were removed. Early laparoscopic diaphragm mapping and DP implantation can successfully wean traumatic cervical SCI patients from ventilator support. Early laparoscopic mapping is also diagnostic in that a nonstimulatable diaphragm is a convincing evidence of an inability to wean from ventilator support, and long-term ventilator management can be immediately instituted. Therapeutic study, level V.

Rapid Automated Quantification of Cerebral Leukoaraiosis on CT Images: A Multicenter Validation Study.

PubMed

Chen, Liang; Carlton Jones, Anoma Lalani; Mair, Grant; Patel, Rajiv; Gontsarova, Anastasia; Ganesalingam, Jeban; Math, Nikhil; Dawson, Angela; Aweid, Basaam; Cohen, David; Mehta, Amrish; Wardlaw, Joanna; Rueckert, Daniel; Bentley, Paul

2018-05-15

Purpose To validate a random forest method for segmenting cerebral white matter lesions (WMLs) on computed tomographic (CT) images in a multicenter cohort of patients with acute ischemic stroke, by comparison with fluid-attenuated recovery (FLAIR) magnetic resonance (MR) images and expert consensus. Materials and Methods A retrospective sample of 1082 acute ischemic stroke cases was obtained that was composed of unselected patients who were treated with thrombolysis or who were undergoing contemporaneous MR imaging and CT, and a subset of International Stroke Thrombolysis-3 trial participants. Automated delineations of WML on images were validated relative to experts' manual tracings on CT images, and co-registered FLAIR MR imaging, and ratings were performed by using two conventional ordinal scales. Analyses included correlations between CT and MR imaging volumes, and agreements between automated and expert ratings. Results Automated WML volumes correlated strongly with expert-delineated WML volumes at MR imaging and CT (r 2 = 0.85 and 0.71 respectively; P < .001). Spatial-similarity of automated maps, relative to WML MR imaging, was not significantly different to that of expert WML tracings on CT images. Individual expert WML volumes at CT correlated well with each other (r 2 = 0.85), but varied widely (range, 91% of mean estimate; median estimate, 11 mL; range of estimated ranges, 0.2-68 mL). Agreements (κ) between automated ratings and consensus ratings were 0.60 (Wahlund system) and 0.64 (van Swieten system) compared with agreements between individual pairs of experts of 0.51 and 0.67, respectively, for the two rating systems (P < .01 for Wahlund system comparison of agreements). Accuracy was unaffected by established infarction, acute ischemic changes, or atrophy (P > .05). Automated preprocessing failure rate was 4%; rating errors occurred in a further 4%. Total automated processing time averaged 109 seconds (range, 79-140 seconds). Conclusion An automated method for quantifying CT cerebral white matter lesions achieves a similar accuracy to experts in unselected and multicenter cohorts. © RSNA, 2018 Online supplemental material is available for this article.

Mass Spectrometry Imaging of Biological Tissue: An Approach for Multicenter Studies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rompp, Andreas; Both, Jean-Pierre; Brunelle, Alain

2015-03-01

Mass spectrometry imaging has become a popular tool for probing the chemical complexity of biological surfaces. This led to the development of a wide range of instrumentation and preparation protocols. It is thus desirable to evaluate and compare the data output from different methodologies and mass spectrometers. Here, we present an approach for the comparison of mass spectrometry imaging data from different laboratories (often referred to as multicenter studies). This is exemplified by the analysis of mouse brain sections in five laboratories in Europe and the USA. The instrumentation includes matrix-assisted laser desorption/ionization (MALDI)-time-of-flight (TOF), MALDI-QTOF, MALDIFourier transform ion cyclotronmore » resonance (FTICR), atmospheric-pressure (AP)-MALDI-Orbitrap, and cluster TOF-secondary ion mass spectrometry (SIMS). Experimental parameters such as measurement speed, imaging bin width, and mass spectrometric parameters are discussed. All datasets were converted to the standard data format imzML and displayed in a common open-source software with identical parameters for visualization, which facilitates direct comparison of MS images. The imzML conversion also allowed exchange of fully functional MS imaging datasets between the different laboratories. The experiments ranged from overview measurements of the full mouse brain to detailed analysis of smaller features (depending on spatial resolution settings), but common histological features such as the corpus callosum were visible in all measurements. High spatial resolution measurements of AP-MALDI-Orbitrap and TOF-SIMS showed comparable structures in the low-micrometer range. We discuss general considerations for planning and performing multicenter studies in mass spectrometry imaging. This includes details on the selection, distribution, and preparation of tissue samples as well as on data handling. Such multicenter studies in combination with ongoing activities for reporting guidelines, a common data format (imzML) and a public data repository can contribute to more reliability and transparency of MS imaging studies.« less

Sevelamer is cost effective versus calcium carbonate for the first-line treatment of hyperphosphatemia in new patients to hemodialysis: a patient-level economic evaluation of the INDEPENDENT-HD study.

PubMed

Ruggeri, Matteo; Bellasi, Antonio; Cipriani, Filippo; Molony, Donald; Bell, Cynthia; Russo, Domenico; Di Iorio, Biagio

2015-10-01

The recent multicenter, randomized, open-label INDEPENDENT study demonstrated that sevelamer improves survival in new to hemodialysis (HD) patients compared with calcium carbonate. The objective of this study was to determine the cost-effectiveness of sevelamer versus calcium carbonate for patients new to HD, using patient-level data from the INDEPENDENT study. Cost-effectiveness analysis. Adult patients new to HD in Italy. A patient-level cost-effectiveness analysis was conducted from the perspective of the Servizio Sanitario Nazionale, Italy's national health service. The analysis was conducted for a 3-year time horizon. The cost of dialysis was excluded from the base case analysis. Sevelamer was compared to calcium carbonate. Total life years (LYs), total costs, and the incremental cost per LY gained were calculated. Bootstrapping was used to estimate confidence intervals around LYs, costs, and cost-effectiveness and to calculate the cost-effectiveness acceptability curve. Sevelamer was associated with a gain of 0.26 in LYs compared to calcium carbonate, over the 3-year time horizon. Total drug costs were €3,282 higher for sevelamer versus calcium carbonate, while total hospitalization costs were €2,020 lower for sevelamer versus calcium carbonate. The total incremental cost of sevelamer versus calcium carbonate was €1,262, resulting in a cost per LY gained of €4,897. The bootstrap analysis demonstrated that sevelamer was cost effective compared with calcium carbonate in 99.4 % of 10,000 bootstrap replicates, assuming a willingness-to-pay threshold of €20,000 per LY gained. Data on hospitalizations was taken from a post hoc retrospective chart review of the patients included in the INDEPENDENT study. Patient quality of life or health utility was not included in the analysis. Sevelamer is a cost-effective alternative to calcium carbonate for the first-line treatment of hyperphosphatemia in new to HD patients in Italy.

Retrospective Video Analysis: A Reflective Tool for Teachers and Teacher Educators

ERIC Educational Resources Information Center

Mosley Wetzel, Melissa; Maloch, Beth; Hoffman, James V.

2017-01-01

Teachers may need tools to use video for reflection toward ongoing toward education and teacher leadership. Based on Goodman's (1996) notion of retrospective miscue analysis, a method of reading instruction that revalues the reader and his or her strategies, retrospective video analysis guides teachers in appreciating and understanding their own…

Population pharmacokinetics of Rilpivirine in HIV-1-infected patients treated with the single-tablet regimen rilpivirine/tenofovir/emtricitabine.

PubMed

Néant, Nadège; Gattacceca, Florence; Lê, Minh Patrick; Yazdanpanah, Yazdan; Dhiver, Catherine; Bregigeon, Sylvie; Mokhtari, Saadia; Peytavin, Gilles; Tamalet, Catherine; Descamps, Diane; Lacarelle, Bruno; Solas, Caroline

2018-04-01

Rilpivirine, prescribed for the treatment of HIV infection, presents an important inter-individual pharmacokinetic variability. We aimed to determine population pharmacokinetic parameters of rilpivirine in adult HIV-infected patients and quantify their inter-individual variability. We conducted a multicenter, retrospective, and observational study in patients treated with the once-daily rilpivirine/tenofovir disoproxil fumarate/emtricitabine regimen. As part of routine therapeutic drug monitoring, rilpivirine concentrations were measured by UPLC-MS/MS. Population pharmacokinetic analysis was performed using NONMEM software. Once the compartmental and random effects models were selected, covariates were tested to explain the inter-individual variability in pharmacokinetic parameters. The final model qualification was performed by both statistical and graphical methods. We included 379 patients, resulting in the analysis of 779 rilpivirine plasma concentrations. Of the observed trough individual plasma concentrations, 24.4% were below the 50 ng/ml minimal effective concentration. A one-compartment model with first-order absorption best described the data. The estimated fixed effect for plasma apparent clearance and distribution volume were 9 L/h and 321 L, respectively, resulting in a half-life of 25.2 h. The common inter-individual variability for both parameters was 34.1% at both the first and the second occasions. The inter-individual variability of clearance was 30.3%. Our results showed a terminal half-life lower than reported and a high proportion of patients with suboptimal rilpivirine concentrations, which highlights the interest of using therapeutic drug monitoring in clinical practice. The population analysis performed with data from "real-life" conditions resulted in reliable post hoc estimates of pharmacokinetic parameters, suitable for individualization of dosing regimen.

Systemic treatment in advanced biliary cancers: A multicenter Australian analysis and review.

PubMed

Brungs, Daniel; Aghmesheh, Morteza; Sjoquist, Katrin; Goldstein, David

2017-10-01

While first-line palliative chemotherapy (CT1) improves survival and quality of life in advanced biliary cancer (ABC), there is no randomized evidence to support second-line chemotherapy (CT2) in ABC. We aim to explore to role of CT2 in ABC. We performed a retrospective review of all patients who received one or more lines of chemotherapy for ABC at four Australian cancer centers between 2008 and 2011. A Cox proportional hazard model was developed to determine the impact of clinicopathologic variables on overall survival (OS) from time of progression on CT1. We identified 73 patients who received palliative chemotherapy for ABC. Twenty-five patients (34%) received two or more lines of chemotherapy. Patients with a preserved performance status on progression on first-line chemotherapy (CT1) were more likely to receive second-line chemotherapy (CT2) (P < 0.001). Disease control rate with CT2 was 36%, and mean progression-free survival was 3.2 months (95% confidence interval 1.5-4.9 months). The following variables were significant in the univariate analysis of OS from time of progression on CT1: lines of chemotherapy (P = 0.0001), Eastern Cooperative Oncology Group performance status at progression on CT1 (P < 0.0001) and disease control with CT1 (P = 0.027). Lines of chemotherapy received and performance status remained significant in the multivariate analysis for OS from progression on CT1. Second-line chemotherapy is feasible in a subset of patients with ABC. Even after accounting for confounding variables, CT2 appears to increase OS in ABC, although we are unable to exclude other unmeasured factors such as tumor biology. These findings warrant further evaluation with prospective trials. © 2016 John Wiley & Sons Australia, Ltd.

Sudden death after pediatric heart transplantation: analysis of data from the Pediatric Heart Transplant Study Group.

PubMed

Daly, Kevin P; Chakravarti, Sujata B; Tresler, Margaret; Naftel, David C; Blume, Elizabeth D; Dipchand, Anne I; Almond, Christopher S

2011-12-01

Sudden death is a well-recognized complication of heart transplantation. Little is known about the incidence and risk factors for sudden death after transplant in children. The purpose of this study was to determine the incidence of and risk factors for sudden death. This retrospective multicenter cohort study used the Pediatric Heart Transplant Study Group (PHTS) database, an event-driven registry of children aged <18 at listing undergoing heart transplantation between 1993 and 2007. Standard Kaplan-Meier and parametric analyses were used for survival analysis. Multivariate analysis in the hazard-function domain was used to identify risk factors for sudden death after transplant. Of 604 deaths in 2,491 children who underwent heart transplantation, 94 (16%) were classified as sudden. Freedom from sudden death was 97% at 5 years, and the hazard for sudden death remained constant over time at 0.01 deaths/year. Multivariate risk factors associated with sudden death included black race (hazard ratio [HR], 2.6; p < 0.0001), United Network of Organ Sharing (UNOS) status 2 at transplant (HR, 1.8; p = 0.008), older age (HR, 1.4/10 years of age; p = 0.03), and an increased number of rejection episodes in the first post-transplant year (HR, 1.6/episode; p = 0.03). Sudden death accounts for 1 in 6 deaths after heart transplant in children. Older recipient age, recurrent rejection within the first year, black race, and UNOS status 2 at listing were associated with sudden death. Patients with 1 or more of these risk factors may benefit from primary prevention efforts. Copyright © 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Use of trastuzumab as an adjuvant/neoadjuvant therapy in patients with HER2-positive breast cancer in China: The Nvwa study.

PubMed

Li, Junjie; Shao, Zhimin; Xu, Binghe; Jiang, Zefei; Cui, Shude; Zhang, Jin; Liao, Ning; Jiang, Jun; Wang, Yongsheng; Ouyang, Quchang; Ying, Ziwei

2018-05-01

The aim of this study was to understand current trends in trastuzumab use in China as a neoadjuvant/adjuvant therapy for human epidermal growth factor receptor-2 positive (HER2+) breast cancer and identify factors influencing trastuzumab use.This was a retrospective, multicenter, cross-sectional study of patients diagnosed with HER2+ breast cancer (stage I-III), between July 2013 and June 2014, at 155 hospitals in 29 provinces/cities in China. Demographic and clinical data, including tumor characteristics and details of adjuvant/neoadjuvant therapies used, were collected. Data analysis included univariate analysis, multivariate logistic regression, and subgroup analyses.Of 4994 HER2+ patients (mean age 51.1 ± 9.9 years) included, only 29.8% received trastuzumab, with 30.5% in adjuvant therapy and 18.3% in neoadjuvant therapy. The highest rates of adjuvant trastuzumab were in Beijing (59.3%), Jiangsu (57.1%), and Ningxia (50.0%), while those of neoadjuvant trastuzumab were in Guangdong (24.8%), Beijing (14.1%), and Zhejiang (10.7%). Multivariate regression results revealed that factors associated with trastuzumab use were medical insurance cover for trastuzumab, residing locally to the hospital, more lymph node involvement, and more advanced tumor stage. Subgroup analysis revealed that patients receiving neoadjuvant therapy were likely to be younger, premenopausal and non-local, and had lymph node metastases, more advanced tumor, and progesterone receptor positive tumor.Trastuzumab use in patients with HER2+ breast cancer is relatively low in China, especially for neoadjuvant therapy. Insurance coverage seems to be the most correlated factor that influences the use of trastuzumab in Chinese patients with HER2+ breast cancer.

Role of lymphadenectomy in intermediate-risk endometrial cancer: a matched-pair study

PubMed Central

2018-01-01

Objective To assess the impact of lymph node dissection (LND) on morbidity, survival, and cost for intermediate-risk endometrial cancers (IREC). Methods A multicenter retrospective cohort of 720 women with IREC (endometrioid histology with myometrial invasion <50% and grade 3; or myometrial invasion ≥50% and grades 1–2; or cervical involvement and grades 1–2) was carried out. All patients underwent hysterectomy and bilateral salpingo-oophorectomy. A matched pair analysis identified 178 pairs (178 with LND and 178 without it) equal in age, body mass index, co-morbidities, American Society of Anesthesiologist score, myometrial invasion, and surgical approach. Demographic data, pathology results, perioperative morbidity, and survival were abstracted from medical records. Disease-free survival (DFS) and overall survival (OS) was analyzed using Kaplan-Meier curves and multivariate Cox regression analysis. Cost analysis was carried out between both groups. Results Both study groups were homogeneous in demographic data and pathologic results. The mean follow-up in patients free of disease was 61.7 months (range, 12.0–275.5). DFS (hazard ratio [HR]=1.34; 95% confidence interval [CI]=0.79–2.28) and OS (HR=0.72; 95% CI=0.42–1.23) were similar in both groups, independently of nodes count. In LND group, positive nodes were found in 10 cases (5.6%). Operating time and late postoperative complications were higher in LND group (p<0.05). Infection rate was significantly higher in no-LND group (p=0.035). There were no statistical differences between both groups regarding operative morbidity and hospital stay. The global cost was similar for both groups. Conclusion Systematic LND in IREC has no benefit on survival, although it does not show an increase in perioperative morbidity or global cost. PMID:29185259

KPS/LDH index: a simple tool for identifying patients with metastatic melanoma who are unlikely to benefit from palliative whole brain radiotherapy.

PubMed

Partl, Richard; Fastner, Gerd; Kaiser, Julia; Kronhuber, Elisabeth; Cetin-Strohmer, Klaudia; Steffal, Claudia; Böhmer-Breitfelder, Barbara; Mayer, Johannes; Avian, Alexander; Berghold, Andrea

2016-02-01

Low Karnofsky performance status (KPS) and elevated lactate dehydrogenases (LDHs) as a surrogate marker for tumor load and cell turnover may depict patients with a very short life expectancy. To validate this finding and compare it to other indices, namely, the recursive partitioning analysis (RPA) and diagnosis-specific graded prognostic assessment (DS-GPA), a multicenter analysis was undertaken. A retrospective analysis of 234 metastatic melanoma patients uniformly treated with palliative whole brain radiotherapy (WBRT) was done. Univariate and multivariate analyses were used to determine the impact of patient-, tumor-, and treatment-related parameters on overall survival (OS). KPS and LDH emerged as independent factors predicting OS. By combining KPS and LDH values (KPS/LDH index), groups of patients with statistically significant differences in median OS (days; 95 % CI) after onset of WBRT were identified: group 1 (KPS ≥ 70/normal LDH) 234 (96-372), group 2 (KPS ≥ 70/elevated LDH) 112 (69-155), group 3 (KPS <70/normal LDH) 43 (12-74), and group 4 (KPS <70/elevated LDH) 29 (17-41). Between all four groups, statistically significant differences were observed. The RPA and DS-GPA indices failed to distinguish significantly between good and moderate prognosis and were inferior in predicting a very unfavorable prognosis. The parameters KPS and LDH independently impacted on OS. The combination of both (KPS/LDH index) identified patients with a very short life expectancy, who might be better served by recommending best supportive care instead of WBRT. The KPS/LDH index is simple and effective in terms of time and cost as compared to other prognostic indices.

Flow-Diverting Devices versus Coil Embolization for Intracranial Aneurysms: A Systematic Literature Review and Meta-analysis.

PubMed

Zhou, Geng; Zhu, Yue-Qi; Su, Ming; Gao, Kai-Di; Li, Ming-Hua

2016-04-01

To review the literature on flow-diverting device (FDD) treatments for intracranial aneurysms (IAs) and to compare the safety and efficacy of FDDs with coil embolization treatment (CET) for IAs using a meta-analysis of published studies. A systematic electronic search was conducted of PubMed, Springer Link, EBSCO, and the Cochrane Database on all accessible published articles through September 2015. Abstracts, full-text manuscripts, and the reference lists of retrieved articles were analyzed. Studies that explicitly compared FDD and CET approaches to the treatment of IAs were included. Odds ratios (ORs) and 95% CIs were calculated for the complete occlusion rate and the morbidity rate using a random-effects model. Nine studies were included in the analysis, containing retrospectively collected data for 863 patients. FDD treatment showed a significantly higher complete occlusion rate than CET (OR = 3.13; 95% confidence interval [CI], 2.11-4.65) and the subgroup of stent-assisted coiling did (OR = 2.08; 95% CI, 1.34-3.24). FDDs did not achieve a significantly lower overall morbidity rate compared with CET (OR = 0.87; 95% CI, 0.45-1.69) or the SAC (stent-assisted coiling) subgroup (OR = 0.86; 95% CI, 0.33-2.26), and our results did not show a significant difference in mortality between the two techniques. FDD treatment of IAs yielded satisfactory results in complete occlusion rate compared with CET. The FDD procedure is feasible and has no significant difference in morbidity risk. Despite the findings reported herein, further validation with well-designed, multicenter randomized controlled trials is needed. Copyright © 2016 Elsevier Inc. All rights reserved.

Predictors of decompressive hemicraniectomy in malignant middle cerebral artery stroke.

PubMed

Kamran, Saadat; Salam, Abdul; Akhtar, Naveed; D'soza, Atlantic; Shuaib, Ashfaq

2018-04-12

Identification of factors in malignant middle cerebral artery (MMCA) stroke patients that may be useful in selecting patients for DHC. This study was a retrospective multicenter study of patients referred for DHC based on the criteria of the randomized control trials of DHC in MMCA stroke. Demographic, clinical, and radiology data were analyzed. Patients who underwent DHC were compared to those who survived without surgery. Two hundred three patients with MMCA strokes were identified: 137 underwent DHC, 47 survived without DHC, and 19 refused surgery and died. Multivariate analysis identified the following factors determining DHC in MMCA stroke: age < 55 years (OR 8.5, 95% CI 3.3-22.1, P < 0.001), MCA with involvement of additional vascular territories (anterior cerebral artery, posterior cerebral artery (OR 4.8, 95% CI 1.5-14.9, P = 0.007), septum pellucidum displacement ≥ 7.5 mm (OR 4.8, 95% CI 1.9-11.7, P = 0.001), diabetes (OR 3.7, 95% CI 1.3-10.6, P = 0.012), infarct growth rate (IGR) ml/h (OR 1.11, 95% CI 1.02-1.2, P = 0.015), and temporal lobe involvement (OR 2.5, 95% CI 1.01-6.1, P = 0.048). The internal validation of the multivariate logistic regression model using bootstrapping analysis showed marginal bias. Among patients with MMCA infarctions, an increased possibility of DHC is associated with younger age, MCA with additional infarction, septum pellucidum deviation of > 7.5 mm, diabetes, IGR, and temporal lobe involvement. The presence of these risk factors identifies those MMCA stroke patients who may require DHC. Bootstrapping analysis indicated the model is good enough to predict the outcome in general population.

Glioblastoma: does the pre-treatment geometry matter? A postcontrast T1 MRI-based study.

PubMed

Pérez-Beteta, Julián; Martínez-González, Alicia; Molina, David; Amo-Salas, Mariano; Luque, Belén; Arregui, Elena; Calvo, Manuel; Borrás, José M; López, Carlos; Claramonte, Marta; Barcia, Juan A; Iglesias, Lidia; Avecillas, Josué; Albillo, David; Navarro, Miguel; Villanueva, José M; Paniagua, Juan C; Martino, Juan; Velásquez, Carlos; Asenjo, Beatriz; Benavides, Manuel; Herruzo, Ismael; Delgado, María Del Carmen; Del Valle, Ana; Falkov, Anthony; Schucht, Philippe; Arana, Estanislao; Pérez-Romasanta, Luis; Pérez-García, Víctor M

2017-03-01

The potential of a tumour's volumetric measures obtained from pretreatment MRI sequences of glioblastoma (GBM) patients as predictors of clinical outcome has been controversial. Mathematical models of GBM growth have suggested a relation between a tumour's geometry and its aggressiveness. A multicenter retrospective clinical study was designed to study volumetric and geometrical measures on pretreatment postcontrast T1 MRIs of 117 GBM patients. Clinical variables were collected, tumours segmented, and measures computed including: contrast enhancing (CE), necrotic, and total volumes; maximal tumour diameter; equivalent spherical CE width and several geometric measures of the CE "rim". The significance of the measures was studied using proportional hazards analysis and Kaplan-Meier curves. Kaplan-Meier and univariate Cox survival analysis showed that total volume [p = 0.034, Hazard ratio (HR) = 1.574], CE volume (p = 0.017, HR = 1.659), spherical rim width (p = 0.007, HR = 1.749), and geometric heterogeneity (p = 0.015, HR = 1.646) were significant parameters in terms of overall survival (OS). Multivariable Cox analysis for OS provided the later two parameters as age-adjusted predictors of OS (p = 0.043, HR = 1.536 and p = 0.032, HR = 1.570, respectively). Patients with tumours having small geometric heterogeneity and/or spherical rim widths had significantly better prognosis. These novel imaging biomarkers have a strong individual and combined prognostic value for GBM patients. • Three-dimensional segmentation on magnetic resonance images allows the study of geometric measures. • Patients with small width of contrast enhancing areas have better prognosis. • The irregularity of contrast enhancing areas predicts survival in glioblastoma patients.

Spinal cord ischemia after simultaneous and sequential treatment of multilevel aortic disease.

PubMed

Piffaretti, Gabriele; Bonardelli, Stefano; Bellosta, Raffaello; Mariscalco, Giovanni; Lomazzi, Chiara; Tolenaar, Jip L; Zanotti, Camilla; Guadrini, Cristina; Sarcina, Antonio; Castelli, Patrizio; Trimarchi, Santi

2014-10-01

The aim of the present study is to report a risk analysis for spinal cord injury in a recent cohort of patients with simultaneous and sequential treatment of multilevel aortic disease. We performed a multicenter study with a retrospective data analysis. Simultaneous treatment refers to descending thoracic and infrarenal aortic lesions treated during the same operation, and sequential treatment refers to separate operations. All descending replacements were managed with endovascular repair. Of 4320 patients, multilevel aortic disease was detected in 77 (1.8%). Simultaneous repair was performed in 32 patients (41.5%), and a sequential repair was performed in 45 patients (58.4%). Postoperative spinal cord injury developed in 6 patients (7.8%). At multivariable analysis, the distance of the distal aortic neck from the celiac trunk was the only independent predictor of postoperative spinal cord injury (odds ratio, 0.75; 95% confidence interval, 0.56-0.99; P=.046); open surgical repair of the abdominal aortic disease was associated with a higher risk of spinal cord injury but did not reach statistical significance (odds ratio, 0.16; 95% confidence interval, 0.02-1.06; P=.057). Actuarial survival estimates at 1, 2, and 5 years after the procedure were 80%±5%, 68%±6%, and 63%±7%, respectively. Spinal cord injury did not impair survival (P=.885). In our experience, the risk of spinal cord injury is still substantial at 8% in patients with multilevel aortic disease. The distance of the distal landing zone from the celiac trunk is a significant predictor of spinal cord ischemia. Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Prospective study of tricuspid valve regurgitation associated with permanent leads in patients undergoing cardiac rhythm device implantation: Background, rationale, and design

PubMed Central

Dokainish, Hisham; Elbarasi, Esam; Masiero, Simona; Van de Heyning, Caroline; Brambatti, Michela; Ghazal, Sami; AL-Maashani, Said; Capucci, Alessandro; Buikema, Lisanne; Leong, Darryl; Shivalkar, Bharati; Saenen, Johan; Miljoen, Hielko; Morillo, Carlos; Divarakarmenon, Syam; Amit, Guy; Ribas, Sebastian; Brautigam, Aaron; Baiocco, Erika; Maolo, Alessandro; Romandini, Andrea; Maffei, Simone; Connolly, Stuart; Healey, Jeff

2015-01-01

Given the increasing numbers of cardiac device implantations worldwide, it is important to determine whether permanent endocardial leads across the tricuspid valve can promote tricuspid regurgitation (TR). Virtually all current data is retrospective, and indicates a signal of TR being increased after permanent lead implantation. However, the precise incidence of moderate or greater TR post-procedure, the exact mechanisms (mechanical, traumatic, functional), and the hemodynamic burden and clinical effects of this putative increase in TR, remain uncertain. We have therefore designed a multicenter, international, prospective study of 300 consecutive patients (recruitment completed, baseline data presented) who will undergo echocardiography and clinical assessment prior to, and at 1-year post device insertion. This prospective study will help determine whether cardiac device-associated TR is real, what are its potential mechanisms, and whether it has an important clinical impact on cardiac device patients. PMID:26779517

Biologic switching between interleukin 17A antagonists secukinumab and ixekizumab: A 12-week, multicenter, retrospective study.

PubMed

Georgakopoulos, Jorge R; Phung, Michelle; Ighani, Arvin; Lam, Kaitlyn; Yeung, Jensen

2018-05-30

A recent review by Hu et al. highlights the use of biologic switching in clinical practice to maximize skin clearance and improve clinical outcomes. However, efficacy and safety outcomes of ixekizumab therapy in patients who did not respond to, lost response, or were intolerant to secukinumab was not mentioned in their review and is lacking. As such, dermatologists may be hesitant to switch between interleukin (IL)-17A antagonists, electing to try an alternative biologic with a different mechanism of action. We recently published a series of 17 patients switching between IL-17A antagonists, suggesting ixekizumab is a promising treatment option with good clinical outcome and few adverse events (AE) for plaque psoriasis patients with prior exposure to secukinumab. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Does colostomy prevent infection in open blunt pelvic fractures? A systematic review.

PubMed

Lunsjo, Karl; Abu-Zidan, Fikri M

2006-05-01

Open pelvic fracture is a rare injury. Our aim in this study is to systematically review the literature to define when diverting colostomy is indicated to protect the patient from infection in open blunt pelvic fractures. Papers studying open pelvic fractures and the use of colostomy were retrieved through MEDLINE and PUBMED. The papers were critically appraised regarding their methodology and conclusions. Relevant information was combined. The level of evidence for the use of colostomy in open pelvic fractures is very low. All reports are retrospective and no statistical methods have been used to support conclusions drawn. We found no difference in the overall infectious complication rate between the colostomy and noncolostomy groups. There is an assumption that patients with perineal wounds would benefit from colostomy; however, rectal involvement in these injuries was not detailed. The role of colostomy in open blunt pelvic fractures is unresolved and randomized multicenter trials are needed.

Minimally invasive sinus augmentation using ultrasonic piezoelectric vibration and hydraulic pressure: a multicenter retrospective study.

PubMed

Kim, Ji-Min; Sohn, Dong-Seok; Heo, Jeong-Uk; Park, Jun-Sub; Jung, Heui-Seung; Moon, Jee-Won; Lee, Ju-Hyoung; Park, In-Sook

2012-12-01

The purpose of this study was to evaluate the success rate of implants and vertical bone gain of edentulous posterior maxilla using ultrasonic piezoelectric vibration and hydraulic pressure, namely the hydrodynamic piezoelectric internal sinus elevation (HPISE) technique through a crestal approach. A total of 250 maxillary sinuses were augmented using HPISE and 353 implants (averaging 11.8 mm in length and 4.5 mm in diameter), with 12 different systems, were placed simultaneously with or without additional bone grafting. Plain radiograms and cone beam computed tomograms were taken in all patients to evaluate sinus augmentation. Membrane perforation was recorded at 10 of the 353 implant sites. The perforation rate was 2.83%. The total success rate of implantation was 97.2% after an average of 69.3 weeks of loading. The crestally approached sinus augmentation using ultrasonic piezoelectric vibration and hydraulic pressure is an additional method of maxillary sinus augmentation.

Forced-Air Warming Discontinued: Periprosthetic Joint Infection Rates Drop.

PubMed

Augustine, Scott D

2017-06-23

Several studies have shown that the waste heat from forced-air warming (FAW) escapes near the floor and warms the contaminated air resident near the floor. The waste heat then forms into convection currents that rise up and contaminate the sterile field above the surgical table. It has been shown that a single airborne bacterium can cause a periprosthetic joint infection (PJI) following joint replacement surgery. We retrospectively compared PJI rates during a period of FAW to a period of air-free conductive fabric electric warming (CFW) at three hospitals. Surgical and antibiotic protocols were held constant. The pooled multicenter data showed a decreased PJI rate of 78% following the discontinuation of FAW and a switch to air-free CFW (n=2034; P=0.002). The 78% reduction in joint implant infections observed when FAW was discontinued suggests that there is a link between the waste FAW heat and PJIs.

Forced-Air Warming Discontinued: Periprosthetic Joint Infection Rates Drop

PubMed Central

Augustine, Scott D.

2017-01-01

Several studies have shown that the waste heat from forced-air warming (FAW) escapes near the floor and warms the contaminated air resident near the floor. The waste heat then forms into convection currents that rise up and contaminate the sterile field above the surgical table. It has been shown that a single airborne bacterium can cause a periprosthetic joint infection (PJI) following joint replacement surgery. We retrospectively compared PJI rates during a period of FAW to a period of air-free conductive fabric electric warming (CFW) at three hospitals. Surgical and antibiotic protocols were held constant. The pooled multicenter data showed a decreased PJI rate of 78% following the discontinuation of FAW and a switch to air-free CFW (n=2034; P=0.002). The 78% reduction in joint implant infections observed when FAW was discontinued suggests that there is a link between the waste FAW heat and PJIs. PMID:28713524

Specific immunotherapy for rhinitis and asthma with a subcutaneous hypoallergenic high-dose house dust mite extract: results of a 9-month therapy.

PubMed

El-Qutob, David; Moreno, Francisco; Subtil-Rodríguez, Alicia

2016-07-01

Effectiveness of a 9-month specific immunotherapy with a subcutaneous hypoallergenic high-dose house dust mite extract to reduce allergic symptoms as perceived by patients and physicians was assessed. An observational, retrospective, multicenter study was carried out in patients diagnosed with asthma and/or rhinitis caused by house dust mites having started specific immunotherapy with Acaroid(®). Primary end point was perceived effectiveness. A total of 409 patients were included. According to physician-completed visual analogue scale, a 58.1% clinical improvement was observed. Patient-completed visual analogue scale showed a 69.8% clinical improvement. The need for unscheduled/emergency healthcare, as an indication of poor quality of life, showed a significant reduction. Our results confirm in a real-world setting the findings from randomized clinical trials of high-dose house dust mites allergoid immunotherapy with a subcutaneous hypoallergenic high-dose house dust mite extract.

Comparison of imported Plasmodium ovale curtisi and P. ovale wallikeri infections among patients in Spain, 2005-2011.

PubMed

Rojo-Marcos, Gerardo; Rubio-Muñoz, José Miguel; Ramírez-Olivencia, Germán; García-Bujalance, Silvia; Elcuaz-Romano, Rosa; Díaz-Menéndez, Marta; Calderón, María; García-Bermejo, Isabel; Ruiz-Giardín, José Manuel; Merino-Fernández, Francisco Jesús; Torrús-Tendero, Diego; Delgado-Iribarren, Alberto; Ribell-Bachs, Mónica; Arévalo-Serrano, Juan; Cuadros-González, Juan

2014-03-01

Sequencing data from Plasmodium ovale genotypes co-circulating in multiple countries support the hypothesis that P. ovale curtisi and P. ovale wallikeri are 2 separate species. We conducted a multicenter, retrospective, comparative study in Spain of 21 patients who had imported P. ovale curtisi infections and 14 who had imported P. ovale wallikeri infections confirmed by PCR and gene sequencing during June 2005-December 2011. The only significant finding was more severe thrombocytopenia among patients with P. ovale wallikeri infection than among those with P. ovale curtisi infection (p = 0.031). However, we also found nonsignificant trends showing that patients with P. ovale wallikeri infection had shorter time from arrival in Spain to onset of symptoms, lower level of albumin, higher median maximum core temperature, and more markers of hemolysis than did those with P. ovale curtisi infection. Larger, prospective studies are needed to confirm these findings.

Clinical utility of level-of-evidence-1 disease forecast cancer biomarkers uPA and its inhibitor PAI-1.

PubMed

Schmitt, Manfred; Mengele, Karin; Napieralski, Rudolf; Magdolen, Viktor; Reuning, Ute; Gkazepis, Apostolos; Sweep, Fred; Brünner, Nils; Foekens, John; Harbeck, Nadia

2010-11-01

The prognostic and/or predictive value of the cancer biomarkers, urokinase-type plasminogen activator (uPA) and its inhibitor (plasminogen activator inhibitor [PAI]-1), determined by ELISA in tumor-tissue extracts, was demonstrated for several cancer types in numerous clinically relevant retrospective or prospective studies, including a multicenter breast cancer therapy trial (Chemo-N0). Consequently, for the first time ever for any cancer biomarker for breast cancer, uPA and PAI-1 have reached the highest level of evidence, level-of-evidence-1. At present, two other breast cancer therapy trials, NNBC-3 and Plan B, also incorporating uPA and PAI-1 as treatment-assignment tools are in effect. Furthermore, small synthetic molecules targeting uPA are currently in Phase II clinical trials in patients afflicted with advanced cancer of the ovary, breast or pancreas.

Multicenter study of quantitative computed tomography analysis using a computer-aided three-dimensional system in patients with idiopathic pulmonary fibrosis.

PubMed

Iwasawa, Tae; Kanauchi, Tetsu; Hoshi, Toshiko; Ogura, Takashi; Baba, Tomohisa; Gotoh, Toshiyuki; Oba, Mari S

2016-01-01

To evaluate the feasibility of automated quantitative analysis with a three-dimensional (3D) computer-aided system (i.e., Gaussian histogram normalized correlation, GHNC) of computed tomography (CT) images from different scanners. Each institution's review board approved the research protocol. Informed patient consent was not required. The participants in this multicenter prospective study were 80 patients (65 men, 15 women) with idiopathic pulmonary fibrosis. Their mean age was 70.6 years. Computed tomography (CT) images were obtained by four different scanners set at different exposures. We measured the extent of fibrosis using GHNC, and used Pearson's correlation analysis, Bland-Altman plots, and kappa analysis to directly compare the GHNC results with manual scoring by radiologists. Multiple linear regression analysis was performed to determine the association between the CT data and forced vital capacity (FVC). For each scanner, the extent of fibrosis as determined by GHNC was significantly correlated with the radiologists' score. In multivariate analysis, the extent of fibrosis as determined by GHNC was significantly correlated with FVC (p < 0.001). There was no significant difference between the results obtained using different CT scanners. Gaussian histogram normalized correlation was feasible, irrespective of the type of CT scanner used.

Burr Hole Washout versus Craniotomy for Chronic Subdural Hematoma: Patient Outcome and Cost Analysis

PubMed Central

Regan, Jacqueline M.; Worley, Emmagene; Shelburne, Christopher; Pullarkat, Ranjit; Watson, Joseph C.

2015-01-01

Chronic subdural hematomas (CSDH), which are frequently encountered in neurosurgical practice, are, in the majority of cases, ideally treated with surgical drainage. Despite this common practice, there is still controversy surrounding the best surgical procedure. With lack of clear evidence of a superior technique, surgeons are free to base the decision on other factors that are not related to patient care. A retrospective chart review of 119 patients requiring surgical drainage of CSDH was conducted at a large tertiary care center over a three-year period. Of the cases reviewed, 58 patients underwent craniotomy, while 61 patients underwent burr hole washout. The study focused on re-operation rates, mortality, and morbidity, as measured by Glasgow coma scores (GCS), discharge Rankin disability scores, and discharge disposition. Secondary endpoints included length of stay and cost of procedure. Burr hole washout was superior to craniotomy with respect to patient outcome, length of stay and recurrence rates. In both study groups, patients required additional surgical procedures (6.6% of burr hole patients and 24.1% of craniotomy patients) (P = 0.0156). Of the patients treated with craniotomy, 51.7% were discharged home, whereas 65.6% of the burr hole patients were discharged home. Patients who underwent burr hole washout spent a mean of 78.8 minutes in the operating suite while the patients undergoing craniotomy spent 129.4 minutes (P < 0.001). The difference in mean cost per patient, based solely on operating time, was $2,828 (P < 0.001). This does not include the further cost due to additional procedures and hospital stay. The mean length of stay after surgical intervention was 3 days longer for the craniotomy group (P = 0.0465). Based on this retrospective study, burr hole washout is superior for both patients’ clinical and financial outcome; however, prospective long-term multicenter clinical studies are required to verify these findings. PMID:25611468

Burr hole washout versus craniotomy for chronic subdural hematoma: patient outcome and cost analysis.

PubMed

Regan, Jacqueline M; Worley, Emmagene; Shelburne, Christopher; Pullarkat, Ranjit; Watson, Joseph C

2015-01-01

Chronic subdural hematomas (CSDH), which are frequently encountered in neurosurgical practice, are, in the majority of cases, ideally treated with surgical drainage. Despite this common practice, there is still controversy surrounding the best surgical procedure. With lack of clear evidence of a superior technique, surgeons are free to base the decision on other factors that are not related to patient care. A retrospective chart review of 119 patients requiring surgical drainage of CSDH was conducted at a large tertiary care center over a three-year period. Of the cases reviewed, 58 patients underwent craniotomy, while 61 patients underwent burr hole washout. The study focused on re-operation rates, mortality, and morbidity, as measured by Glasgow coma scores (GCS), discharge Rankin disability scores, and discharge disposition. Secondary endpoints included length of stay and cost of procedure. Burr hole washout was superior to craniotomy with respect to patient outcome, length of stay and recurrence rates. In both study groups, patients required additional surgical procedures (6.6% of burr hole patients and 24.1% of craniotomy patients) (P = 0.0156). Of the patients treated with craniotomy, 51.7% were discharged home, whereas 65.6% of the burr hole patients were discharged home. Patients who underwent burr hole washout spent a mean of 78.8 minutes in the operating suite while the patients undergoing craniotomy spent 129.4 minutes (P < 0.001). The difference in mean cost per patient, based solely on operating time, was $2,828 (P < 0.001). This does not include the further cost due to additional procedures and hospital stay. The mean length of stay after surgical intervention was 3 days longer for the craniotomy group (P = 0.0465). Based on this retrospective study, burr hole washout is superior for both patients' clinical and financial outcome; however, prospective long-term multicenter clinical studies are required to verify these findings.

Cisplatin- Versus Non-Cisplatin-based First-Line Chemotherapy for Advanced Urothelial Carcinoma Previously Treated With Perioperative Cisplatin.

PubMed

Locke, Jennifer A; Pond, Gregory Russell; Sonpavde, Guru; Necchi, Andrea; Giannatempo, Patrizia; Paluri, Ravi Kumar; Niegisch, Guenter; Albers, Peter; Buonerba, Carlo; Di Lorenzo, Giuseppe; Vaishampayan, Ulka N; North, Scott A; Agarwal, Neeraj; Hussain, Syed A; Pal, Sumanta; Eigl, Bernhard J

2016-08-01

The optimal choice of first-line chemotherapy for patients with relapse of urothelial carcinoma (UC) after perioperative cisplatin-based chemotherapy (PCBC) is unclear. We investigated the outcomes with cisplatin rechallenge versus a non-cisplatin regimen in patients with recurrent metastatic UC after PCBC in a multicenter retrospective study. Individual patient-level data were collected for patients who had received various first-line chemotherapy regimens for advanced UC after previous PCBC. Cox proportional hazards models were used to investigate the prognostic ability of the type of perioperative and first-line chemotherapy to independently affect overall survival (OS) and progression-free survival (PFS) after accounting for known prognostic factors. Data were available for 145 patients (12 centers). The mean age was 62 years; the Eastern Cooperative Oncology Group (ECOG) performance status (PS) was > 0 for 42.0% of the patients. Of the 145 patients, 63% had received cisplatin-based first-line chemotherapy. The median time from previous chemotherapy (TFPC) was 6.2 months (range, 1-154 months). The median OS was 22 months (95% confidence interval [CI], 18-27 months), and the median PFS was 6 months (95% CI, 5-7 months). A better ECOG PS and a longer TFPC (> 12 months vs. ≤ 12 months; hazard ratio [HR], 0.32; 95% CI, 0.20-0.52; P < .001) was prognostic for OS and PFS. Cisplatin-based chemotherapy was associated with poor OS (HR, 1.86; 95% CI, 1.13-3.06; P = .015), which appeared to be pronounced in those patients with a TFPC of ≤ 12 months. Retreatment with cisplatin in the first-line setting was associated with worse OS (HR, 3.38; P < .001). The results of the present retrospective analysis suggest that for patients who have undergone previous PCBC for UC, rechallenging with cisplatin might confer a poorer OS, especially for those with progression within < 1 year. Copyright © 2015 Elsevier Inc. All rights reserved.

Chronic lateral ankle instability surgical repairs: the long term prospective.

PubMed

Mabit, C; Tourné, Y; Besse, J-L; Bonnel, F; Toullec, E; Giraud, F; Proust, J; Khiami, F; Chaussard, C; Genty, C

2010-06-01

The present study sought to assess the clinical and radiological results and long-term joint impact of different techniques of lateral ankle ligament reconstruction. A multicenter retrospective review was performed on 310 lateral ankle ligament reconstructions, with a mean 13-year-follow-up (minimum FU: 5 years). Male subjects (53%) and sports trauma (78%) predominated. Mean duration of instability was 92 months; mean age at surgery was 28 years. Twenty-eight percent of cases showed subtalar joint involvement. Four classes of surgical technique were distinguished: C1, direct capsular ligamentous complex reattachment; C2, augmented repair; C3, ligamentoplasty using part of the peroneus brevis tendon and C4, ligamentoplasty using the whole peroneus brevis tendon. Clinical and functional assessment used Karlsson and Good-Jones-Livingstone scores; radiologic assessment combined centered AP and lateral views, hindfoot weight-bearing Méary views and dynamic views (manual technique, Telos or self-imposed varus). The majority of results (92%) were satisfactory. The mean Karlsson score of 90 [19-100] (i.e., 87% good and very good results) correlated with the subjective assessment, and did not evolve over time. Postoperative complications (20%), particularly when neurologic, were associated with poorer results. Control X-ray confirmed the very minor progression in degenerative changes, with improved stability; there was, however, no correlation between functional result and residual laxity on X-ray. Unstable and painful ankles showed poorer clinical results and more secondary osteoarthritis. Analysis by class of technique found poorer results in C4-type plasties and poorer control of laxity on X-ray in C1-type tension restoration. The present results confirm the interest of lateral ankle ligamentoplasty in the management of instability and protection against secondary osteoarthritis, and of precise lesion assessment (CT-scan/MRI) to adapt surgery to the ligamentary and associated lesions. Level IV. Retrospective therapeutic study. Copyright 2010 Elsevier Masson SAS. All rights reserved.

Presence of acute and chronic renal failure in patients with paroxysmal nocturnal hemoglobinuria: results of a retrospective analysis from the Spanish PNH Registry.

PubMed

Villegas, Ana; Núñez, Ramiro; Gaya, Anna; Cuevas-Ruiz, María Victoria; Bosch, José Miguel; Carral, Anna; Arrizabalaga, Beatriz; Gómez-Roncero, María Isabel; Mora, Asunción; Bravo, Pilar; Lavilla, Esperanza; Monteserín, Carmen; Hernández, Belén; Martínez-Barranco, Pilar; Jarque, Isidro; Urquía, María Anunciación; García-Donas, Gloria; Brunet, Salut; González, Fernando Ataulfo; Urbano, Álvaro

2017-10-01

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening blood disease. With the advent of eculizumab treatment, renal function has substantially improved, although no data from real-world clinical practice are available. An observational, retrospective, multicenter study was conducted in Spain on clinical data obtained from outpatient visits of patients with PNH (Spanish PNH Registry) who had experienced acute (ARF) or chronic (CRF) renal failure. Of the 128 patients registered (April 2014), 60 were diagnosed with classic PNH. Twenty-seven (45.0%) patients with a mean age of 48.5 (±16.2) years had renal failure, ARF or CRF, and were included in this study. Near half of the patients (n = 13; 48.1%) presented with ARF alone, 33.3% (n = 9) had CRF with episodes of ARF, while 18.5% (n = 5) were diagnosed with CRF alone. For patients with diagnosis of PNH and renal failure (n = 27), the median time to the first ARF episode was 6.5 (CI 95%; 2.2, 14.9) years, whereas the median to the diagnosis of CRF was 14.5 (CI 95%; 3.8, 19.2) years after the diagnosis of PNH. Patients with ARF (n = 22) were treated with eculizumab and did not experience new episodes of ARF, except for one patient with sepsis. Of the patients with CRF, two received treatment without experiencing further episodes of ARF. Sixteen patients who completed treatment (11 with ARF and 5 with ARF + CRF) recovered from the episode of ARF or from CRF. Of the remaining patients treated with eculizumab, one patient improved from stages III to II, three patients stabilized without showing disease progression, and one patient progressed from stages III to IV. Treatment with eculizumab in PNH patients has beneficial effects on renal function, preventing ARF and progression to CRF.

Diagnosed hematological malignancies in Bangladesh - a retrospective analysis of over 5000 cases from 10 specialized hospitals.

PubMed

Hossain, Mohammad Sorowar; Iqbal, Mohd S; Khan, Mohiuddin Ahmed; Rabbani, Mohammad Golam; Khatun, Hazera; Munira, Sirajam; Miah, M Morshed Zaman; Kabir, Amin Lutful; Islam, Naima; Dipta, Tashmim Farhana; Rahman, Farzana; Mottalib, Abdul; Afrose, Salma; Ara, Tasneem; Biswas, Akhil Ranjan; Rahman, Mizanur; Abedin, Akm Mustafa; Rahman, Mahbubur; Yunus, A B M; Niessen, Louis W; Sultana, Tanvira Afroze

2014-06-14

The global burden from cancer is rising, especially as low-income countries like Bangladesh observe rapid aging. So far, there are no comprehensive descriptions reporting diagnosed cancer group that include hematological malignancies in Bangladesh. This was a multi-center hospital-based retrospective descriptive study of over 5000 confirmed hematological cancer cases in between January 2008 to December 2012. Morphological typing was carried out using the "French American British" classification system. A total of 5013 patients aged between 2 to 90 years had been diagnosed with malignant hematological disorders. A 69.2% were males (n=3468) and 30.8% females (n=1545), with a male to female ratio of 2.2:1. The overall median age at diagnosis was 42 years. Acute myeloid leukemia was most frequent (28.3%) with a median age of 35 years, followed by chronic myeloid leukemia with 18.2% (median age 40 years), non-Hodgkin lymphoma (16.9%; median age 48 years), acute lymphoblastic leukemia (14.1%; median age 27 years), multiple myeloma (10.5%; median age 55 years), myelodysplastic syndromes (4.5%; median age 57 years) and Hodgkin's lymphoma (3.9%; median age 36 years). The least common was chronic lymphocytic leukemia (3.7%; median age 60 years). Below the age of 20 years, acute lymphoblastic leukemia was predominant (37.3%), followed by acute myeloid leukemia (34%). Chronic lymphocytic leukemia and multiple myeloma had mostly occurred among older patients, aged 50-over. For the first time, our study presents the pattern and distribution of diagnosed hematological cancers in Bangladesh. It shows differences in population distributions as compared to other settings with possibly a lower presence of non-Hodgkin lymphoma. There might be under-reporting of affected women. Further studies are necessary on the epidemiology, genetics and potential environmental risk factors within this rapidly aging country.

Diagnosed hematological malignancies in Bangladesh - a retrospective analysis of over 5000 cases from 10 specialized hospitals

PubMed Central

2014-01-01

Background The global burden from cancer is rising, especially as low-income countries like Bangladesh observe rapid aging. So far, there are no comprehensive descriptions reporting diagnosed cancer group that include hematological malignancies in Bangladesh. Methods This was a multi-center hospital-based retrospective descriptive study of over 5000 confirmed hematological cancer cases in between January 2008 to December 2012. Morphological typing was carried out using the “French American British” classification system. Results A total of 5013 patients aged between 2 to 90 years had been diagnosed with malignant hematological disorders. A 69.2% were males (n = 3468) and 30.8% females (n = 1545), with a male to female ratio of 2.2:1. The overall median age at diagnosis was 42 years. Acute myeloid leukemia was most frequent (28.3%) with a median age of 35 years, followed by chronic myeloid leukemia with 18.2% (median age 40 years), non-Hodgkin lymphoma (16.9%; median age 48 years), acute lymphoblastic leukemia (14.1%; median age 27 years), multiple myeloma (10.5%; median age 55 years), myelodysplastic syndromes (4.5%; median age 57 years) and Hodgkin’s lymphoma (3.9%; median age 36 years). The least common was chronic lymphocytic leukemia (3.7%; median age 60 years). Below the age of 20 years, acute lymphoblastic leukemia was predominant (37.3%), followed by acute myeloid leukemia (34%). Chronic lymphocytic leukemia and multiple myeloma had mostly occurred among older patients, aged 50-over. Conclusions For the first time, our study presents the pattern and distribution of diagnosed hematological cancers in Bangladesh. It shows differences in population distributions as compared to other settings with possibly a lower presence of non-Hodgkin lymphoma. There might be under-reporting of affected women. Further studies are necessary on the epidemiology, genetics and potential environmental risk factors within this rapidly aging country. PMID:24929433

Primary Gastrointestinal Lymphoma

PubMed Central

Chen, Yinting; Chen, Yanzhu; Chen, Shaojie; Wu, Lili; Xu, Lishu; Lian, Guoda; Yang, Kege; Li, Yaqing; Zeng, Linjuan; Huang, Kaihong

2015-01-01

Abstract Primary gastrointestinal lymphoma (PGIL) is a rare malignant tumor without standard diagnosis and treatment methods. This study is aimed to systematically analyze its clinical characteristics and draw out an appropriate flow chart of diagnosis and treatment process for PGIL in China. This study retrospectively analyzed the clinicopathological characteristics, diagnostic approaches, prognostic factors, and therapeutic modalities in 415 cases of PGIL in Chinese province of Guangdong. A systematic review was conducted in 118 studies containing 5075 patients to further identify clinical manifestations and mortalities of therapeutic modalities. The most common clinical presentations were abdominal pain and bloody stools. Endoscopic biopsy was an important diagnostic means, and usually more than once to make a definite diagnosis. Retrospective multicenter clinical study showed that younger onset age (<60 years), female, one region involved, one lesion, early stage, International Prognostic Index (IPI ≤1), normal lactate dehydrogenase (LDH), normal albumin, and nonemergency operation were significant prognostic factors for B-cell lymphoma; non-B symptom, tumor restricted to gastric or ileocecal region, one lesion, performance status (PS ≤1), normal LDH, and nonsurgery alone were significant prognostic factors for T-cell lymphoma. Site of origin and IPI were independent prognostic factors for B-cell lymphoma; PS was the independent prognostic factor for T-cell lymphoma. And T-cell lymphoma had worse overall survival (OS) and progression-free survival (PFS) than B-cell lymphoma. Among different therapeutic modalities, chemotherapy alone or combined with surgery showed better OS and PFS than surgery alone for diffuse large B-cell lymphoma (DLBCL) of stage I/II E and T-cell lymphoma. For DLBCL of stage III E/IV and mucosa-associated lymphoid tissue lymphoma, OS and PFS did not differ among different therapeutic groups. In meta-analysis, surgery plus chemotherapy showed lowest mortality. Chemotherapy alone or combined with surgery may be the first-line treatment for DLBCL of stage I/II E and T-cell lymphoma. A flow chart of diagnosis and treatment process for PGIL was approximately drew out. PMID:26632732

Relationship between fracture of mandibular condyle and absence of unerupted mandibular third molar-a retrospective study.

PubMed

Rajan, Ritesh; Verma, Dinesh Kumar; Borle, R M; Yadav, Abhilasha

2016-06-01

The purpose of the present study was to find, if there exists, a co-relation between presence of unerupted mandibular third molar and fracture of mandibular condyle. A retrospective, multicenter study was done collecting the data of all mandibular condyle fractures treated from November 2006 till August 2015. Data was collected from the patient's records and radiographs for the following information: age, sex, etiology of fracture, presence and state of lower third molars, and associated fracture. The results were subjected to statistical analysis. Out of 180 patients of condylar fracture, unerupted third molars were present in 35 (19.44 %) cases compared to 145 (80.55 %) cases of condylar fracture where the unerupted third molars were not present. The difference was statistically significant (p < 0.05). In the unerupted third molar present group, isolated bilateral condylar fracture was seen in 4 (11.4 %) cases, bilateral condylar fracture associated with other mandibular fractures in 9 (25.7 %) cases, isolated unilateral condylar fracture in 0 (0.0 %) cases, and unilateral condylar fracture associated with other mandibular fractures in 17 (48.5 %) cases and condylar fracture associated with mid face fractures in 5 (14.2 %) cases. In the unerupted third molar absent group, isolated bilateral condylar fracture was seen in 5 (3.4 %) cases, bilateral condylar fracture associated with other mandibular fractures in 30 (20.6 %) cases, isolated unilateral condylar fracture in 24 (16.5 %) cases, unilateral condylar fracture associated with other mandibular fractures in 73 (50.34 %) cases, and condylar fracture associated with mid face fractures in 13(8.96 %) cases. The difference between the groups was statistically significant (p = 0.032). This study suggests that the fractures of mandibular condylar region have a significantly higher incidence in patients without an unerupted mandibular third molar.

Delayed Diagnoses in Children with Constipation: Multicenter Retrospective Cohort Study.

PubMed

Freedman, Stephen B; Rodean, Jonathan; Hall, Matthew; Alpern, Elizabeth R; Aronson, Paul L; Simon, Harold K; Shah, Samir S; Marin, Jennifer R; Cohen, Eyal; Morse, Rustin B; Katsogridakis, Yiannis; Berry, Jay G; Neuman, Mark I

2017-07-01

The use of abdominal radiographs contributes to increased healthcare costs, radiation exposure, and potentially to misdiagnoses. We evaluated the association between abdominal radiograph performance and emergency department (ED) revisits with important alternate diagnosis among children with constipation. Retrospective cohort study of children aged <18 years diagnosed with constipation at one of 23 EDs from 2004 to 2015. The primary exposure was abdominal radiograph performance. The primary outcome was a 3-day ED revisit with a clinically important alternate diagnosis. RAND/University of California, Los Angeles methodology was used to define whether the revisit was related to the index visit and due to a clinically important condition other than constipation. Regression analysis was performed to identify exposures independently related to the primary outcome. A total of 65.7% (185 439/282 225) of children with constipation had an index ED visit abdominal radiograph performed. Three-day revisits occurred in 3.7% (10 566/282 225) of children, and 0.28% (784/282 225) returned with a clinically important alternate related diagnosis. Appendicitis was the most common such revisit, accounting for 34.1% of all 3-day clinically important related revisits. Children who had an abdominal radiograph performed were more likely to have a 3-day revisit with a clinically important alternate related diagnosis (0.33% vs 0.17%; difference 0.17%; 95% CI 0.13-0.20). Following adjustment for covariates, abdominal radiograph performance was associated with a 3-day revisit with a clinically important alternate diagnosis (aOR: 1.39; 95% CI 1.15-1.67). Additional characteristics associated with the primary outcome included narcotic (aOR: 2.63) and antiemetic (aOR: 2.35) administration and underlying comorbidities (aOR: 2.52). Among children diagnosed with constipation, abdominal radiograph performance is associated with an increased risk of a revisit with a clinically important alternate related diagnosis. Copyright © 2017 Elsevier Inc. All rights reserved.

Histoplasmosis complicating tumor necrosis factor-α blocker therapy: a retrospective analysis of 98 cases.

PubMed

Vergidis, Paschalis; Avery, Robin K; Wheat, L Joseph; Dotson, Jennifer L; Assi, Maha A; Antoun, Smyrna A; Hamoud, Kassem A; Burdette, Steven D; Freifeld, Alison G; McKinsey, David S; Money, Mary E; Myint, Thein; Andes, David R; Hoey, Cynthia A; Kaul, Daniel A; Dickter, Jana K; Liebers, David E; Miller, Rachel A; Muth, William E; Prakash, Vidhya; Steiner, Frederick T; Walker, Randall C; Hage, Chadi A

2015-08-01

Histoplasmosis may complicate tumor necrosis factor (TNF)-α blocker therapy. Published case series provide limited guidance on disease management. We sought to determine the need for long-term antifungal therapy and the safety of resuming TNF-α blocker therapy after successful treatment of histoplasmosis. We conducted a multicenter retrospective review of 98 patients diagnosed with histoplasmosis between January 2000 and June 2011. Multivariate logistic regression was used to evaluate risk factors for severe disease. The most commonly used biologic agent was infliximab (67.3%). Concomitant corticosteroid use (odds ratio [OR], 3.94 [95% confidence interval {CI}, 1.06-14.60]) and higher urine Histoplasma antigen levels (OR, 1.14 [95% CI, 1.03-1.25]) were found to be independent predictors of severe disease. Forty-six (47.4%) patients were initially treated with an amphotericin B formulation for a median duration of 2 weeks. Azole treatment was given for a median of 12 months. TNF-α blocker therapy was initially discontinued in 95 of 98 (96.9%) patients and later resumed in 25 of 74 (33.8%) patients at a median of 12 months (range, 1-69 months). The recurrence rate was 3.2% at a median follow-up period of 32 months. Of the 3 patients with recurrence, 2 had restarted TNF-α blocker therapy, 1 of whom died. Mortality rate was 3.2%. In this study, disease outcomes were generally favorable. Discontinuation of antifungal treatment after clinical response and an appropriate duration of therapy, probably at least 12 months, appears safe if pharmacologic immunosuppression has been held. Resumption of TNF-α blocker therapy also appears safe, assuming that the initial antifungal therapy was administered for 12 months. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Early Support of Intracranial Perfusion

DTIC Science & Technology

2009-10-01

outcomes after traumatic brain injury: A multicenter analysis. Archives of Physical Medicine and Rehabilitation, 84(10), 1441- 1448. Cremer , O. L...Kolesnik Research Assistant 67.5 Sean Jordan Research Assistant 44.5 Sara Wade Research Assistant 90 David Prakash Research Assistant 63.6 Scott Berry

Development of Novel Criteria of the "Lethal Triad" as an Indicator of Decision Making in Current Trauma Care: A Retrospective Multicenter Observational Study in Japan.

PubMed

Endo, Akira; Shiraishi, Atsushi; Otomo, Yasuhiro; Kushimoto, Shigeki; Saitoh, Daizoh; Hayakawa, Mineji; Ogura, Hiroshi; Murata, Kiyoshi; Hagiwara, Akiyoshi; Sasaki, Junichi; Matsuoka, Tetsuya; Uejima, Toshifumi; Morimura, Naoto; Ishikura, Hiroyasu; Takeda, Munekazu; Kaneko, Naoyuki; Kato, Hiroshi; Kudo, Daisuke; Kanemura, Takashi; Shibusawa, Takayuki; Hagiwara, Yasushi; Furugori, Shintaro; Nakamura, Yoshihiko; Maekawa, Kunihiko; Mayama, Gou; Yaguchi, Arino; Kim, Shiei; Takasu, Osamu; Nishiyama, Kazutaka

2016-09-01

To evaluate the utility of the conventional lethal triad in current trauma care practice and to develop novel criteria as indicators of treatment strategy. Retrospective observational study. Fifteen acute critical care medical centers in Japan. In total, 796 consecutive trauma patients who were admitted to emergency departments with an injury severity score of greater than or equal to 16 from January 2012 to December 2012. None. All data were retrospectively collected, including laboratory data on arrival. Sensitivities to predict trauma death within 28 days of prothrombin time international normalized ratio greater than 1.50, pH less than 7.2, and body temperature less than 35°C were 15.7%, 17.5%, and 15.9%, respectively, and corresponding specificities of these were 96.4%, 96.6%, and 93.6%, respectively. The best predictors associated with hemostatic disorder and acidosis were fibrin/fibrinogen degradation product and base excess (the cutoff values were 88.8 µg/mL and -3.05 mmol/L). The optimal cutoff value of hypothermia was 36.0°C. The impact of the fibrin/fibrinogen degradation product and base excess abnormality on the outcome were approximately three- and two-folds compared with those of hypothermia. Using these variables, if the patient had a hemostatic disorder alone or a combined disorder with acidosis and hypothermia, the sensitivity and specificity were 80.7% and 66.8%. Because of the low sensitivity and high specificity, conventional criteria were unsuitable as prognostic indicators. Our revised criteria are assumed to be useful for predicting trauma death and have the potential to be the objective indicators for activating the damage control strategy in early trauma care.

Clinical Outcomes, Efficacy, and Adverse Events in Patients Undergoing Esophageal Stent Placement for Benign Indications: A Large Multicenter Study.

PubMed

Suzuki, Takayuki; Siddiqui, Ali; Taylor, Linda J; Cox, Kristen; Hasan, Raza A; Laique, Sobia N; Mathew, Arun; Wrobel, Piotr; Adler, Douglas G

2016-01-01

Esophageal stents are commonly used to treat benign esophageal conditions including refractory benign esophageal strictures, anastomotic strictures, fistulae, perforations and anastomotic leaks. Data on outcomes in these settings remain limited. We performed a retrospective multicenter study of patients who underwent fully or partially covered self-expandable stent placement for benign esophageal diseases. Esophageal stent placements were performed for the following indications: (1) benign refractory esophageal strictures, (2) surgical anastomotic strictures, (3) esophageal perforations, (4) esophageal fistulae, and (5) surgical anastomotic leaks. A total of 70 patients underwent esophageal stent placement for benign esophageal conditions. A total of 114 separate procedures were performed. The most common indication for esophageal stent placement was refractory benign esophageal stricture (48.2%). Global treatment success rate was 55.7%. Treatment success rate was 33.3% in refractory benign strictures, 23.1% in anastomotic strictures, 100% in perforations, 71.4% in fistulae, and 80% in anastomotic leaks. Stent migration was noted in 28 of 70 patients (40%), most commonly seen in refractory benign strictures. This is one of the largest studies to date of esophageal stents to treat benign esophageal diseases. Success rates are lowest in benign esophageal strictures. These patients have few other options beyond chronic dilations, feeding tubes, and surgery, and fully covered self-expandable metallic stent give patients a chance to have their problem fixed endoscopically and still eat by mouth. Perforations, fistulas, and leaks respond very well to esophageal stenting, and stenting should be considered as a first-line therapy in these settings.

Study of the Factors Leading to Fetal and Neonatal Dysthyroidism in Children of Patients With Graves Disease

PubMed Central

Estellat, Candice; Biran, Valerie; Desfrere, Luc; Champion, Valerie; Benachi, Alexandra; Ville, Yves; Dommergues, Marc; Jarreau, Pierre-Henri; Mokhtari, Mostafa; Boithias, Claire; Brioude, Frederic; Mandelbrot, Laurent; Ceccaldi, Pierre-François; Mitanchez, Delphine; Polak, Michel; Luton, Dominique

2017-01-01

Context: Neonatal hyperthyroidism was first described in 1912 and in 1964 was shown to be linked to transplacental passage of maternal antibodies. Few multicenter studies have described the perinatal factors leading to fetal and neonatal dysthyroidism. Objective: To show how fetal dysthyroidism (FD) and neonatal dysthyroidism (ND) can be predicted from perinatal variables, in particular, the levels of anti-thyrotropin receptor antibodies (TRAbs) circulating in the mother and child. Design and Patients: This was a retrospective multicenter study of data from the medical records of all patients monitored for pregnancy from 2007 to 2014. Setting: Among 280,000 births, the medical records of 2288 women with thyroid dysfunction were selected and screened, and 417 women with Graves disease and positive for TRAbs during pregnancy were included. Results: Using the maternal TRAb levels, the cutoff value of 2.5 IU/L best predicted for FD, with a sensitivity of 100% and specificity of 64%. Using the newborn TRAb levels, the cutoff value of 6.8 IU/L best predicted for ND, with a sensitivity of 100% and a specificity of 94%. In our study, 65% of women with a history of Graves disease did not receive antithyroid drugs during pregnancy but still had infants at risk of ND. Conclusions: In pregnant women with TRAb levels ≥2.5 IU/L, fetal ultrasound monitoring is essential until delivery. All newborns with TRAb levels ≥6.8 IU/L should be examined by a pediatrician with special attention for thyroid dysfunction and treated, if necessary. PMID:29130077

Left Atrial Appendage Morphology and Embolic Stroke of Undetermined Source: A Cross-Sectional Multicenter Pilot Study.

PubMed

Yaghi, Shadi; Chang, Andrew D; Hung, Peter; Mac Grory, Brian; Collins, Scott; Gupta, Ajay; Reynolds, Jacques; Finn, Caitlin B; Hemendinger, Morgan; Cutting, Shawna M; McTaggart, Ryan A; Jayaraman, Mahesh; Leasure, Audrey; Sansing, Lauren; Panda, Nikhil; Song, Christopher; Chu, Antony; Merkler, Alexander; Gialdini, Gino; Sheth, Kevin N; Kamel, Hooman; Elkind, Mitchell S V; Greer, David; Furie, Karen; Atalay, Michael

2018-06-01

The left atrial appendage (LAA) is the main source of thrombus in atrial fibrillation, and there is an association between non-chicken wing (NCW) LAA morphology and stroke. We hypothesized that the prevalence of NCW LAA morphology would be higher among patients with cardioembolic (CE) stroke and embolic stroke of undetermined source (ESUS) than among those with noncardioembolic stroke (NCS). This multicenter retrospective pilot study included consecutive patients with ischemic stroke from 3 comprehensive stroke centers who previously underwent a qualifying chest computed tomography (CT) to assess LAA morphology. Patients underwent inpatient diagnostic evaluation for ischemic stroke, and stroke subtype was determined based on ESUS criteria. LAA morphology was determined using clinically performed contrast enhanced thin-slice chest CT by investigators blinded to stroke subtype. The primary predictor was NCW LAA morphology and the outcome was stroke subtype (CE, ESUS, NCS). We identified 172 patients with ischemic stroke who had a clinical chest CT performed. Mean age was 70.1 ± 14.3 years and 51.7% were male. Compared with patients with NCS, the prevalence of NCW LAA morphology was higher in patients with CE stroke (58.7% versus 46.3%, P = .1) and ESUS (58.8% versus 46.3%, P = .2), but this difference did not achieve statistical significance. The prevalence of NCW LAA morphology may be similar in patients with ESUS and CE, and may be higher than that in those with NCS. Larger studies are needed to confirm these associations. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Short-segment transverse myelitis lesions in a cohort of Latin American patients with neuromyelitis optica spectrum disorders.

PubMed

Carnero Contentti, Edgar; Daccach Marques, Vanessa; Soto de Castillo, Ibis; Tkachuk, Verónica; Antunes Barreira, Amilton; Armas, Elizabeth; Chiganer, Edson; de Aquino Cruz, Camila; Di Pace, José Luis; Hryb, Javier Pablo; Lavigne Moreira, Carolina; Lessa, Carmen; Molina, Omaira; Perassolo, Mónica; Soto, Arnoldo; Caride, Alejandro

2018-05-22

Multicenter retrospective study. The aim was to determine the frequency and magnetic resonance imaging (MRI) features of short-segment transverse myelitis (STM) in patients with neuromyelitis optica spectrum disorders (NMOSD) during a myelitis attack. Latin American diagnostic centres (Neuroimmunology Unit). A multicenter study from Argentina, Brazil and Venezuela was performed. Seventy-six patients with NMOSD were included. We analyzed 346 attacks and reviewed spinal cord MRIs performed within 30 days from spinal attack onset. Sagittal and axial characteristics on cervical and thoracic MRI (1.5 tesla) were observed. Demographics, clinical, serological, and disability data were collected. Among the 76 patients with NMOSD, isolated STM was observed in 8% (n = 6), multisegmental lesions (longitudinally extensive transverse myelitis (LETM) + STM) in 28% (n = 21; 13 had at least one STM), LETM in 42% (n = 32), and normal spinal MRI in 22% (n = 17). However, isolated STM was increased by 10% in patients with NMOSD with spinal lesions (6 out of 59) with mean attacks of 2.5 (±0.83) and last follow-up expanded disability status scale (EDSS) of 3.1 (±2.63). Positive aquaporin 4 antibodies (AQP4-ab) were found in 50%. Upper-cervical lesion was most frequently observed (5 out of 6). Myelitis was preceded by ON in all isolated patients with STM. Only one had a positive gadolinium lesion and none of these had asymptomatic spinal cord lesion. Isolated STM does not exclude NMOSD diagnosis. Therefore, APQ4-ab testing could be useful during a myelitis attack with STM.

Web-based documentation system with exchange of DICOM RT for multicenter clinical studies in particle therapy

NASA Astrophysics Data System (ADS)

Kessel, Kerstin A.; Bougatf, Nina; Bohn, Christian; Engelmann, Uwe; Oetzel, Dieter; Bendl, Rolf; Debus, Jürgen; Combs, Stephanie E.

2012-02-01

Conducting clinical studies is rather difficult because of the large variety of voluminous datasets, different documentation styles, and various information systems, especially in radiation oncology. In this paper, we describe our development of a web-based documentation system with first approaches of automatic statistical analyses for transnational and multicenter clinical studies in particle therapy. It is possible to have immediate access to all patient information and exchange, store, process, and visualize text data, all types of DICOM images, especially DICOM RT, and any other multimedia data. Accessing the documentation system and submitting clinical data is possible for internal and external users (e.g. referring physicians from abroad, who are seeking the new technique of particle therapy for their patients). Thereby, security and privacy protection is ensured with the encrypted https protocol, client certificates, and an application gateway. Furthermore, all data can be pseudonymized. Integrated into the existing hospital environment, patient data is imported via various interfaces over HL7-messages and DICOM. Several further features replace manual input wherever possible and ensure data quality and entirety. With a form generator, studies can be individually designed to fit specific needs. By including all treated patients (also non-study patients), we gain the possibility for overall large-scale, retrospective analyses. Having recently begun documentation of our first six clinical studies, it has become apparent that the benefits lie in the simplification of research work, better study analyses quality and ultimately, the improvement of treatment concepts by evaluating the effectiveness of particle therapy.

Long-term follow-up of patients with an isolated ovarian recurrence after conservative treatment of epithelial ovarian cancer: review of the results of an international multicenter study comprising 545 patients.

PubMed

Bentivegna, Enrica; Fruscio, Robert; Roussin, Stephanie; Ceppi, Lorenzo; Satoh, Toyomi; Kajiyama, Hiroaki; Uzan, Catherine; Colombo, Nicoletta; Gouy, Sebastien; Morice, Philippe

2015-11-01

To determine the long-term outcomes of patients with an isolated ovarian recurrence after fertility sparing surgery (FSS) for epithelial ovarian cancer (EOC) and to evaluate the recurrence rates (and location) according to the new 2014 International Federation of Gynecology and Obstetrics (FIGO) staging system. Retrospective multicenter study. Teams having reported recurrence after FSS for EOC. Four series comprising 545 patients undergoing FSS and 63 (12%) recurrences. FSS (salpingo-oophorectomy for a majority of cases) for EOC. Recurrences rates and characteristics of recurrent disease. Among 63 recurrent patients, 24 (38%) recurrences were isolated on the spared ovary, and 39 (62%) arose at an extraovarian site. Among the patients with an isolated ovarian recurrence, three patients died after a median follow-up period of 186 months (range: 28-294 months). Among the patients with recurrent extraovarian disease, 24 died and 7 were alive with persistent disease after a median follow-up period of 34 months (range: 3-231 months). The overall rate of isolated ovarian and extrapelvic recurrences was higher for grade 3 tumors (compared with grades 1/2). The long-term survival of patients with an isolated ovarian recurrence after FSS for EOC remains favorable. The prognosis of patients with an extraovarian recurrence is poor compared with those who have an isolated recurrent ovarian tumor. Grade 3 tumors (compared to grades 1/2) give rise to a higher rate of extraovarian recurrences. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Efficacy of infliximab rescue therapy in patients with chronic refractory pouchitis: a multicenter study.

PubMed

Barreiro-de Acosta, M; García-Bosch, O; Souto, R; Mañosa, M; Miranda, J; García-Sanchez, V; Gordillo, J; Chacon, S; Loras, C; Carpio, D; Maroto, N; Menchén, L; Rojas-Feria, M; Sierra, M; Villoria, A; Marin-Jimenez, I

2012-05-01

Despite medical therapy, 30% of patients with ulcerative colitis (UC) need to undergo surgery. Around 50% of patients with proctocolectomy with ileal pouch-anal anastomosis (IPAA) develop complications of the pouch. Clinical evidence for the use of infliximab (IFX) in refractory pouchitis is limited. The aim of this study was to report efficacy of IFX in these patients. A retrospective, multicenter study was designed. Patients older than 18 years with chronic refractory pouchitis treated with IFX (5 mg/kg) were included. Short-term IFX efficacy was evaluated at week 8 and mid-term efficacy at weeks 26 and 52. Complete response was defined as cessation of diarrhea and urgency and partial response as marked clinical improvement but persisting symptoms. The modified Pouchitis Disease Activity Index (mPDAI) without endoscopy was calculated when available. Thirty-three consecutive UC patients with chronic refractory pouchitis were included (18 male, mean age 45 years, range 21-67). At week 8, 21% patients achieved complete response and 63% showed partial clinical response. At weeks 26 and 52, 33% and 27% achieved complete response and 33% and 18% showed partial clinical response, respectively. Thirteen patients (39%) withdrew treatment (four for lack of efficacy, four for loss of response and five for adverse events). None of the potential factors analyzed had an influence on response to IFX. IFX was effective in the short- and mid-term in patients with chronic refractory pouchitis. However, medication had to be discontinued in a high number of patients. Copyright © 2011 Crohn's & Colitis Foundation of America, Inc.

Factors predictive of adverse events following endoscopic papillary large balloon dilation: results from a multicenter series.

PubMed

Park, Soo Jung; Kim, Jin Hong; Hwang, Jae Chul; Kim, Ho Gak; Lee, Don Haeng; Jeong, Seok; Cha, Sang-Woo; Cho, Young Deok; Kim, Hong Ja; Kim, Jong Hyeok; Moon, Jong Ho; Park, Sang-Heum; Itoi, Takao; Isayama, Hiroyuki; Kogure, Hirofumi; Lee, Se Joon; Jung, Kyo Tae; Lee, Hye Sun; Baron, Todd H; Lee, Dong Ki

2013-04-01

Lack of established guidelines for endoscopic papillary large balloon dilation (EPLBD) may be a reason for aversion of its use in removal of large common bile duct (CBD) stones. We sought to identify factors predictive of adverse events (AEs) following EPLBD. This multicenter retrospective study investigated 946 consecutive patients who underwent attempted removal of CBD stones ≥10 mm in size using EPLBD (balloon size 12-20 mm) with or without endoscopic sphincterotomy (EST) at 12 academic medical centers in Korea and Japan. Ninety-five (10.0 %) patients exhibited AEs including bleeding in 56, pancreatitis in 24, perforation in nine, and cholangitis in six; 90 (94.7 %) of these were classified as mild or moderate in severity. There were four deaths, three as a result of perforation and one due to delayed massive bleeding. Causative factors identified in fatal cases were full-EST and continued balloon inflation despite a persistent waist seen fluoroscopically. Multivariate analyses showed that cirrhosis (OR 8.03, p = 0.003), length of EST (full-EST: OR 6.22, p < 0.001) and stone size (≥16 mm: OR 4.00, p < 0.001) were associated with increased bleeding, and distal CBD stricture (OR 17.08, p < 0.001) was an independent predictor for perforation. On the other hand, balloon size was associated with deceased pancreatitis (≥14 mm: OR 0.27, p = 0.015). EPLBD appears to be a safe and effective therapeutic approach for retrieval of large stones in patients without distal CBD strictures and when performed without full-EST.

Multicenter study on costs associated with two surgical procedures: GreenLight XPS 180 W versus the gold standard transurethral resection of the prostate.

PubMed

Benejam-Gual, J M; Sanz-Granda, A; Budía, A; Extramiana, J; Capitán, C

2014-01-01

To analyze the costs associated with two surgical procedures for lower urinary tract symptoms secondary to benign prostatic hyperplasia: GreenLight XPS 180¦W versus the gold standard transurethral resection of the prostate. A multicenter, retrospective cost study was carried out from the National Health Service perspective, over a 3-month time period. Costs were broken down into pre-surgical, surgical and post-surgical phases. Data were extracted from records of patients operated sequentially, with IPSS=15, Qmax=15 mL/seg and a prostate volume of 40-80mL, adding only direct healthcare costs (€, 2013) associated with the procedure and management of complications. A total of 79 patients sequentially underwent GL XPS (n: 39) or TURP (n: 40) between July and October, 2013. Clinical outcomes were similar (94.9% and 92.5%, GL XPS and TURP, respectively) without significant differences (P=.67). The average direct cost per patient was reduced by €114 in GL XPS versus TURP patients; the cost was higher in the surgical phase with GL XPS (difference: €1,209; P<.001) but was lower in the post-surgical phase (difference: €-1,351; P<.001). The GreenLight XPS 180-W laser system is associated with a reduction in costs with respect to transurethral resection of prostate in the surgical treatment of LUTS secondary to PBH. This reduction is due to a shorter inpatient length of stay that offsets the cost of the new technology. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

DEXAMETHASONE IMPLANT FOR DIABETIC MACULAR EDEMA IN NAIVE COMPARED WITH REFRACTORY EYES: The International Retina Group Real-Life 24-Month Multicenter Study. The IRGREL-DEX Study.

PubMed

Iglicki, Matias; Busch, Catharina; Zur, Dinah; Okada, Mali; Mariussi, Miriana; Chhablani, Jay Kumar; Cebeci, Zafer; Fraser-Bell, Samantha; Chaikitmongkol, Voraporn; Couturier, Aude; Giancipoli, Ermete; Lupidi, Marco; Rodríguez-Valdés, Patricio J; Rehak, Matus; Fung, Adrian Tien-Chin; Goldstein, Michaella; Loewenstein, Anat

2018-04-24

To investigate efficacy and safety of repeated dexamethasone (DEX) implants over 24 months, in diabetic macular edema (DME) eyes that were treatment naive compared with eyes refractory to anti-vascular endothelial growth factor treatment, in a real-life environment. This multicenter international retrospective study assessed best-corrected visual acuity and central subfield thickness (CST) of naive and refractory eyes to anti-vascular endothelial growth factor injections treated with dexamethasone implants. Safety data (intraocular pressure rise and cataract surgery) were recorded. A total of 130 eyes from 125 patients were included. Baseline best-corrected visual acuity and CST were similar for naive (n = 71) and refractory eyes (n = 59). Both groups improved significantly in vision after 24 months (P < 0.001). However, naive eyes gained statistically significantly more vision than refractory eyes (+11.3 ± 10.0 vs. 7.3 ± 2.7 letters, P = 0.01) and were more likely to gain ≥10 letters (OR 3.31, 95% CI 1.19-9.24, P = 0.02). At 6, 12, and 24 months, CST was significantly decreased compared with baseline in both naive and refractory eyes; however, CST was higher in refractory eyes than in naive eyes (CST 279 ± 61 vs. 313 ± 125 μm, P = 0.10). Over a follow-up of 24 months, vision improved in diabetic macular edema eyes after treatment with dexamethasone implants, both in eyes that were treatment naive and eyes refractory to anti-vascular endothelial growth factor treatment; however, improvement was greater in naive eyes.

Crotalidae polyvalent immune Fab: in patients with North American crotaline envenomation.

PubMed

Keating, Gillian M

2011-04-01

Crotalidae polyvalent immune Fab is an antivenom comprising purified, sheep-derived, Fab IgG fragments and is indicated for use in patients with North American crotaline envenomation. Crotalidae polyvalent immune Fab is produced using four North American snake venoms: Crotalus atrox, Crotalus adamanteus, Crotalus scutulatus, and Agkistrodon piscivorus. Intravenous crotalidae polyvalent immune Fab was effective in patients aged ≥10 years who had minimal or moderate envenomation by a North American crotaline, who presented within 6 hours of the snakebite, and who had progression of the envenomation syndrome, according to the results of two prospective trials. One trial was a noncomparative, multicenter pilot study and the other trial was a randomized, open-label, multicenter trial in which patients received scheduled or 'as needed' administration of crotalidae polyvalent immune Fab after initial control had been achieved. A prospective, postmarketing trial demonstrated the efficacy of crotalidae polyvalent immune Fab in confirmed Crotalus viridis helleri envenomation (indicating cross-protection against a venom not used in its production). Results of these prospective trials are supported by the findings of additional (mainly retrospective) studies demonstrating the efficacy of crotalidae polyvalent immune Fab in patients with crotaline envenomation, including patients with severe envenomation, pediatric patients, and patients with symptoms of neurotoxicity. Despite treatment with crotalidae polyvalent immune Fab, patients may experience delayed-onset or recurrent venom effects (e.g. coagulopathy). Intravenous crotalidae polyvalent immune Fab was generally well tolerated; acute hypersensitivity reactions (e.g. urticaria, rash, pruritus) were the most commonly occurring adverse event. © 2011 Adis Data Information BV. All rights reserved.

Prevalence of vestibular and balance disorders in children and adolescents according to age: A multi-center study.

PubMed

Lee, Jong Dae; Kim, Chang-Hee; Hong, Seok Min; Kim, Sung Huhn; Suh, Myung-Whan; Kim, Min-Beom; Shim, Dae Bo; Chu, Hosuk; Lee, No Hee; Kim, Minbum; Hong, Sung Kwang; Seo, Jae-Hyun

2017-03-01

Children differ from adults in the expression of dizziness symptoms and the causes of dizziness. In several studies, benign paroxysmal vertigo of childhood (BPVC) and vestibular migraine (VM) were seen exclusively in children with vertigo, but the age threshold used to define 'children' varies, and there are few reported studies about adolescents with dizziness. In this study, we investigated the prevalence of vestibular and balance disorders according to age category in a multi-center study (otolaryngology departments of 11 hospitals) of children and adolescents. Children and adolescents aged under 18 who visited the otolaryngology departments of 11 hospitals for dizziness were included. We classified the patients into three categories: preschool (up to and including 6-year-olds), school age (7- to 12-year-olds), and adolescents (13- to 18-year-olds). These patients were reviewed retrospectively based on their clinical charts. In the preschool age group, BPVC was most common, followed by VM. In the school-age group, BPVC and VMs were most common, followed by psychogenic vertigo and benign paroxysmal positional vertigo (BPPV). In adolescents, VM was the most common, and Ménière's disease, cardiogenic vertigo, and BPVC, which are seen primarily in adults, were also seen in some adolescents. In children and adolescents with dizziness, VM and BPVC were the most common diseases, and prevalence of disease by age showed differing distributions. These findings will help in diagnosing and managing children and adolescents with vertigo. Copyright © 2017 Elsevier B.V. All rights reserved.

Tibiotalocalcaneal fusion using the hindfoot arthrodesis nail: a multicenter study.

PubMed

Rammelt, Stefan; Pyrc, Jaroslaw; Agren, Per-Henrik; Hartsock, Langdon A; Cronier, Patrick; Friscia, David A; Hansen, Sigvard T; Schaser, Klaus; Ljungqvist, Jan; Sands, Andrew K

2013-09-01

Tibiotalocalcaneal arthrodesis is a salvage option for severe ankle and hindfoot deformities, arthritis of the ankle and subtalar joints, avascular necrosis of the talus, failed total ankle arthroplasty, and Charcot arthropathy. This multicenter study reports clinical experience with the hindfoot arthrodesis nail (HAN) in the treatment of patients with severe ankle and foot abnormalities. Seven participating clinics from Europe and North America recruited 38 patients who underwent ankle/subtalar arthrodesis using retrograde nailing with the HAN. Information was collected regarding technical details, complications, and functional and quality of life outcomes (Short Form-36 [SF-36], American Academy of Orthopaedic Surgeons-Foot and Ankle Outcomes [AAOS-FAO], and numeric rating scale [NRS] for pain) after an average of 2 years of follow-up. The rate of superficial wound infection was 2.4%. No deep soft tissue or bone infections were reported. The overall union rate was 84%. At the time of follow-up, low pain levels were reported, with a mean NRS of 2.2; the mean AAOS-FAO score was 38; and the SF-36 mean physical and mental health component scores were 41.2 and 52.5, respectively. All 13 patients who were unable to work prior to surgery were able to fully return to work. The HAN offered a safe and reliable salvage option for tibiotalocalcaneal arthrodesis in patients with severe ankle and hindfoot disease. It achieved acceptable functional outcome and low complication rates despite the challenging patient cohort. A considerable socioeconomic benefit appeared to result based on the high proportion of patients who were able to return to work postoperatively. Level IV, retrospective case series.

Prognostic factors of liver cirrhosis mortality after a first episode of spontaneous bacterial peritonitis. A multicenter study.

PubMed

Melcarne, Luigi; Sopeña, Julia; Martínez-Cerezo, Francisco José; Vergara, Mercedes; Miquel, Mireia; Sánchez-Delgado, Jordi; Dalmau, Blai; Machlab, Salvador; Portilla, Dustin; González-Padrón, Yonaisy; Real Álvarez, Mónica; Carpintero, Chantal; Casas, Meritxell

2018-02-01

Spontaneous bacterial peritonitis is an infectious complication with a negative impact on survival of patients with cirrhosis. To analyze the short- and long-term survival after a first episode of bacterial peritonitis and the associated prognostic factors. This was a retrospective, multicenter study of patients admitted to hospital for spontaneous bacterial peritonitis between 2008 and 2013. Independent variables related to mortality were analyzed by logistic regression. The prognostic power of the Child Pugh Score, the Model for End-Stage Liver Disease (MELD) and the Charlson index was analyzed by ROC curve. A total of 159 patients were enrolled, 72% were males with a mean age of 63.5 years and a mean MELD score of 19 (SD ± 9.5). Mortality at 30 and 90 days and one and two years was 21%, 31%, 55% and 69%, respectively. Hepatic encephalopathy (p = 0.008, OR 3.5, 95% CI 1.4-8.8) and kidney function (p = 0.026, OR 2.7, 95% CI 1.13-16.7) were independent factors for short- and long-term mortality. MELD was a good marker of short- and long-term survival (area under the curve [AUC] 0.7: 95% CI 1.02-1.4). The Charlson index was related to long-term mortality (AUC 0.68: 95% CI 0.6-0.77). Short- and long-term mortality of spontaneous bacterial peritonitis is still high. The main prognostic factors for mortality are impairment of liver and kidney function. MELD and the Charlson index are good markers of survival.

Isolated optic nerve gliomas: a multicenter historical cohort study.

PubMed

Shofty, Ben; Ben-Sira, Liat; Kesler, Anat; Jallo, George; Groves, Mari L; Iyer, Rajiv R; Lassaletta, Alvaro; Tabori, Uri; Bouffet, Eric; Thomale, Ulrich-Wilhelm; Hernáiz Driever, Pablo; Constantini, Shlomi

2017-12-01

OBJECTIVE Isolated optic nerve gliomas (IONGs) constitute a rare subgroup of optic pathway gliomas (OPGs). Due to the rarity of this condition and the difficulty in differentiating IONGs from other types of OPGs in most clinical series, little is known about these tumors. Currently, due to lack of evidence, they are managed the same as any other OPG. METHODS The authors conducted a multicenter retrospective cohort study aimed at determining the natural history of IONGs. Included were patients with clear-cut glioma of the optic nerve without posterior (chiasmatic/hypothalamic) involvement. At least 1 year of follow-up, 2 MRI studies, and 2 neuro-ophthalmological examinations were required for inclusion. RESULTS Thirty-six patients with 39 tumors were included in this study. Age at diagnosis ranged between 6 months and 16 years (average 6 years). The mean follow-up time was 5.6 years. Twenty-five patients had neurofibromatosis Type 1. During the follow-up period, 59% of the tumors progressed, 23% remained stable, and 18% (all with neurofibromatosis Type 1) displayed some degree of spontaneous regression. Fifty-one percent of the patients presented with visual decline, of whom 90% experienced further deterioration. Nine patients were treated with chemotherapy, 5 of whom improved visually. Ten patients underwent operation, and no local or distal recurrence was noted. CONCLUSIONS Isolated optic nerve gliomas are highly dynamic tumors. Radiological progression and visual deterioration occur in greater percentages than in the general population of patients with OPGs. Response to chemotherapy may be better in this group, and its use should be considered early in the course of the disease.

Evaluation of the influence of the definition of an isolated hip fracture as an exclusion criterion for trauma system benchmarking: a multicenter cohort study.

PubMed

Tiao, J; Moore, L; Porgo, T V; Belcaid, A

2016-06-01

To assess whether the definition of an IHF used as an exclusion criterion influences the results of trauma center benchmarking. We conducted a multicenter retrospective cohort study with data from an integrated Canadian trauma system. The study population included all patients admitted between 1999 and 2010 to any of the 57 adult trauma centers. Seven definitions of IHF based on diagnostic codes, age, mechanism of injury, and secondary injuries, identified in a systematic review, were used. Trauma centers were benchmarked using risk-adjusted mortality estimates generated using the Trauma Risk Adjustment Model. The agreement between benchmarking results generated under different IHF definitions was evaluated with correlation coefficients on adjusted mortality estimates. Correlation coefficients >0.95 were considered to convey acceptable agreement. The study population consisted of 172,872 patients before exclusion of IHF and between 128,094 and 139,588 patients after exclusion. Correlation coefficients between risk-adjusted mortality estimates generated in populations including and excluding IHF varied between 0.86 and 0.90. Correlation coefficients of estimates generated under different definitions of IHF varied between 0.97 and 0.99, even when analyses were restricted to patients aged ≥65 years. Although the exclusion of patients with IHF has an influence on the results of trauma center benchmarking based on mortality, the definition of IHF in terms of diagnostic codes, age, mechanism of injury and secondary injury has no significant impact on benchmarking results. Results suggest that there is no need to obtain formal consensus on the definition of IHF for benchmarking activities.

Proportion of Uterine Malignant Tumors in Patients with Laparoscopic Myomectomy: A National Multicenter Study in China

PubMed Central

Yang, Hua; Li, Xiao-Chuan; Yao, Chen; Lang, Jing-He; Jin, Hang-Mei; Xi, Ming-Rong; Wang, Gang; Wang, Lu-Wen; Hao, Min; Ding, Yan; Chen, Jie; Zhang, Jian-Qing; Han, Lu; Guo, Cheng-Xiu; Xue, Xiang; Li, Yan; Zheng, Jian-Hua; Cui, Man-Hua; Li, Huai-Fang; Tao, Guang-Shi; Chen, Long; Wang, Su-Min; Lu, An-Wei; Huang, Ze-Hua; Liu, Qing; Zhuang, Ya-Li; Huang, Xiang-Hua; Zhu, Gen-Hai; Huang, Ou-Ping; Hu, Li-Na; Li, Mu-Jun; Zhou, Hong-Lin; Song, Jing-Hui; Zhu, Lan

2017-01-01

Background: The Food and Drug Administration recently announced that the use of morcellation may cause fibroids or pelvic dissemination and metastasis of uterine sarcoma; therefore, the use of morcellation is limited in the USA. A large sample study is necessary to assess the proportion of uterine malignant tumors found in patients with laparoscopic myomectomy. Methods: A national multicenter study was performed in China. From 2002 to 2014, 33,723 cases were retrospectively selected. We calculated the prevalence and recorded the clinical characteristics of the patients with malignancy after morcellation application. A total of 62 cases were finally pathologically confirmed as malignant postoperatively. Additionally, the medical records of the 62 patients were analyzed in details. Results: The proportion of postoperative malignancy after morcellation application was 0.18% (62/33,723) for patients who underwent laparoscopic myomectomy. Nearly 62.9% (39/62) of patients had demonstrated blood flow signals in the uterine fibroids before surgery. And, 23 (37.1%) patients showed rapid growth at the final preoperative ultrasound. With respect to the pathological types, 38 (61.3%) patients had detectable endometrial stromal sarcoma, 13 (21.0%) had detectable uterine leiomyosarcoma, only 3 (3.2%) had detectable carcinosarcoma, and 5 (8.1%) patients with leiomyoma had an undetermined malignant potential. Conclusions: The proportion of malignancy is low after using morcellation in patients who undergo laparoscopic myomectomy. Patients with fast-growing uterine fibroids and abnormal ultrasonic tumor blood flow should be considered for malignant potential, and morcellation should be avoided. PMID:29133752

A Multicenter Performance Evaluation of a Blood Glucose Monitoring System in 21 Leading Hospitals in Spain

PubMed Central

Bedini, José Luis; Wallace, Jane F.; Petruschke, Thorsten; Pardo, Scott

2015-01-01

Background: Self-monitoring of blood glucose is crucial for the effective self-management of diabetes. The present study evaluated the accuracy of the Contour® XT blood glucose monitoring system (BGMS) compared to the reference method in a large multicenter study under routine lab conditions at each hospital site. Methods: This study was conducted at 21 leading hospitals in Spain using leftover whole blood samples (n = 2100). Samples were tested with the BGMS using 1 commercial strip lot and the local laboratory hexokinase method. BGMS accuracy was assessed and results were compared to ISO 15197:2013 accuracy limit criteria and by using mean absolute relative difference analysis (MARD), consensus (Parkes) error grid (CEG), and surveillance error grid analyses (SEG). Results: Pooled analysis of 2100 measurements from all sites showed that 99.43% of the BGMS results were within the ranges accepted by the accuracy limit criteria. The overall MARD was 3.85%. MARD was 4.47% for glucose concentrations < 70 mg/dL and 3.81% for concentrations of 70-300 mg/dL. In CEG, most results (99.8%) were within zone A (“no effect on clinical action”); the remaining ones (0.2%) were in zone B (“little to no effect on clinical action”). The SEG analysis showed that most of the results (98.4%) were in the “no risk” zone, with the remaining results in the “slight, lower” risk zone. Conclusions: This is the largest multicenter study of Contour XT BGMS to date, and shows that this BGMS meets the ISO 15197:2013 accuracy limit criteria under local routine conditions in 21 leading Spanish hospitals. PMID:26253142

A Multicenter Performance Evaluation of a Blood Glucose Monitoring System in 21 Leading Hospitals in Spain.

PubMed

Bedini, José Luis; Wallace, Jane F; Petruschke, Thorsten; Pardo, Scott

2015-08-07

Self-monitoring of blood glucose is crucial for the effective self-management of diabetes. The present study evaluated the accuracy of the Contour® XT blood glucose monitoring system (BGMS) compared to the reference method in a large multicenter study under routine lab conditions at each hospital site. This study was conducted at 21 leading hospitals in Spain using leftover whole blood samples (n = 2100). Samples were tested with the BGMS using 1 commercial strip lot and the local laboratory hexokinase method. BGMS accuracy was assessed and results were compared to ISO 15197:2013 accuracy limit criteria and by using mean absolute relative difference analysis (MARD), consensus (Parkes) error grid (CEG), and surveillance error grid analyses (SEG). Pooled analysis of 2100 measurements from all sites showed that 99.43% of the BGMS results were within the ranges accepted by the accuracy limit criteria. The overall MARD was 3.85%. MARD was 4.47% for glucose concentrations < 70 mg/dL and 3.81% for concentrations of 70-300 mg/dL. In CEG, most results (99.8%) were within zone A ("no effect on clinical action"); the remaining ones (0.2%) were in zone B ("little to no effect on clinical action"). The SEG analysis showed that most of the results (98.4%) were in the "no risk" zone, with the remaining results in the "slight, lower" risk zone. This is the largest multicenter study of Contour XT BGMS to date, and shows that this BGMS meets the ISO 15197:2013 accuracy limit criteria under local routine conditions in 21 leading Spanish hospitals. © 2015 Diabetes Technology Society.

[Clinical features of invasive candidiasis and risk factors for Candida bloodstream infection in children: a multicenter study in Urumqi, China].

PubMed

Ai Er Ken, Ai Bi Bai; Ma, Zhi-Hua; Xiong, Dai-Qin; Xu, Pei-Ru

2017-04-01

To investigate the clinical features of invasive candidiasis in children and the risk factors for Candida bloodstream infection. A retrospective study was performed on 134 children with invasive candidiasis and hospitalized in 5 tertiary hospitals in Urumqi, China, between January 2010 and December 2015. The Candida species distribution was investigated. The clinical data were compared between the patients with and without Candida bloodstream infection. The risk factors for Candida bloodstream infection were investigated using multivariate logistic regression analysis. A total of 134 Candida strains were isolated from 134 children with invasive candidiasis, and non-albicans Candida (NAC) accounted for 53.0%. The incidence of invasive candidiasis in the PICU and other pediatric wards were 41.8% and 48.5% respectively. Sixty-eight patients (50.7%) had Candida bloodstream infection, and 45 patients (33.6%) had Candida urinary tract infection. There were significant differences in age, rate of use of broad-spectrum antibiotics, and incidence rates of chronic renal insufficiency, heart failure, urinary catheterization, and NAC infection between the patients with and without Candida bloodstream infection (P<0.05). The multivariate logistic regression analysis showed that younger age (1-24 months) (OR=6.027) and NAC infection (OR=1.020) were the independent risk factors for Candida bloodstream infection. The incidence of invasive candidiasis is similar between the PICU and other pediatric wards. NAC is the most common species of invasive candidiasis. Candida bloodstream infection is the most common invasive infection. Younger age (1-24 months) and NAC infection are the risk factors for Candida bloodstream infection.

Seven deadly sins in trauma outcomes research: an epidemiologic post mortem for major causes of bias.

PubMed

del Junco, Deborah J; Fox, Erin E; Camp, Elizabeth A; Rahbar, Mohammad H; Holcomb, John B

2013-07-01

Because randomized clinical trials in trauma outcomes research are expensive and complex, they have rarely been the basis for the clinical care of trauma patients. Most published findings are derived from retrospective and occasionally prospective observational studies that may be particularly susceptible to bias. The sources of bias include some common to other clinical domains, such as heterogeneous patient populations with competing and interdependent short- and long-term outcomes. Other sources of bias are unique to trauma, such as rapidly changing multisystem responses to injury that necessitate highly dynamic treatment regimens such as blood product transfusion. The standard research design and analysis strategies applied in published observational studies are often inadequate to address these biases. Drawing on recent experience in the design, data collection, monitoring, and analysis of the 10-site observational PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, 7 common and sometimes overlapping biases are described through examples and resolution strategies. Sources of bias in trauma research include ignoring (1) variation in patients' indications for treatment (indication bias), (2) the dependency of intervention delivery on patient survival (survival bias), (3) time-varying treatment, (4) time-dependent confounding, (5) nonuniform intervention effects over time, (6) nonrandom missing data mechanisms, and (7) imperfectly defined variables. This list is not exhaustive. The mitigation strategies to overcome these threats to validity require epidemiologic and statistical vigilance. Minimizing the highlighted types of bias in trauma research will facilitate clinical translation of more accurate and reproducible findings and improve the evidence-base that clinicians apply in their care of injured patients.

Multicenter analysis of treatment outcomes in adult patients with lymphoblastic lymphoma who received hyper-CVAD induction followed by hematopoietic stem cell transplantation.

PubMed

Jeong, Seong Hyun; Moon, Joon Ho; Kim, Jin Seok; Yang, Deok-Hwan; Park, Yong; Cho, Seok Goo; Kwak, Jae-Yong; Eom, Hyeon Seok; Won, Jong Ho; Hong, Jun Shik; Oh, Sung Yong; Lee, Ho Sup; Kim, Seok Jin

2015-04-01

The hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (hyper-CVAD) regimen has been widely used for lymphoblastic lymphoma (LBL) as a primary treatment. However, there is few data about its treatment outcome in Asian patients. Thus, we conducted this study to evaluate the efficacy of hyper-CVAD induction and stem cell transplantation (SCT) consolidation in LBL patients. The treatment responses of 49 patients treated with the hyper-CVAD regimen were retrospectively analyzed in 13 institutions. Given 24 patients who responded to hyper-CVAD underwent consolidation treatment with SCT, overall survival (OS) and progression-free survival (PFS) of patients who received SCT were compared with patients who did not. The overall response rate was 79 %: 73 % (36/49) complete responses, 6 % (3/49) partial responses, and 4 % (2/49) induction deaths. The major limitation for the delivery of the planned hyper-CVAD cycles was hematological toxicity. Among 39 responders, 24 patients underwent autologous (n = 16) and allogeneic SCT (n = 8) consolidation. Their 3-year OS and PFS rates were 76 and 78 %, respectively, and there was no difference in survival outcomes between autologous and allogeneic SCT. However, 15 patients without SCT consolidation showed poorer PFS even though they all achieved complete response. Thus, only seven patients maintained their response at the time of analysis. In conclusion, the hyper-CVAD regimen is effective for remission induction in LBL, and SCT consolidation after hyper-CVAD induction produced better clinical outcomes than did continuation of hyper-CVAD.

Calcification of Hydrophilic Acrylic Intraocular Lenses With a Hydrophobic Surface: Laboratory Analysis of 6 Cases.

PubMed

Gartaganis, Sotirios P; Prahs, Philipp; Lazari, Eftichia D; Gartaganis, Panos S; Helbig, Horst; Koutsoukos, Petros G

2016-08-01

To investigate the nature and characteristic features of deposits causing opacification of intraocular lenses (IOLs) based on the examination of clinical findings using scanning electron microscopy (SEM) and energy-dispersive x-ray spectroscopy (EDX) analysis. Retrospective, observational case series. This is a multicenter study of 6 hydrophilic acrylic IOLs (Lentis LS-502-1; Oculentis GmbH, Berlin, Germany) with a hydrophobic surface that were explanted from 5 patients because of opacification. Three patients had an uncomplicated phacoemulsification. One patient underwent combined phacoemulsification and pars plana vitrectomy for retinal detachment and later silicone oil endotamponade owing to redetachment. The last patient had a pars plana vitrectomy and silicone oil instillation combined with phacoemulsification for tractive retinal detachment and diabetic retinopathy. The explanted lenses were submitted to our laboratory and were examined by SEM and EDX in order to identify the morphologic features and the composition of the deposits. SEM and EDX analyses confirmed the presence of calcific deposits in the interior of the opacified hydrophilic IOLs, with a pattern showing the formation of lumps on the surface. The lumps were due to subsurface formation of calcium phosphate crystalline deposits. The crystallite clusters seemed to diffuse from the IOL interior to the surface. We demonstrated the calcification pattern of the hydrophilic IOL (Lentis LS-502-1) with a hydrophobic surface. Although hydrophilic acrylic lenses have a hydrophobic surface, the development of calcification is a possible threat initiating from the hydrophilic subsurface of the IOLs. Copyright © 2016 Elsevier Inc. All rights reserved.

Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial

PubMed Central

Zhang, Heping; Williams, Joanne; Santoro, Nanette F.; Diamond, Michael P.; Schlaff, William D.; Coutifaris, Christos; Carson, Sandra A.; Steinkampf, Michael P.; Carr, Bruce R.; McGovern, Peter G.; Cataldo, Nicholas A.; Gosman, Gabriella G.; Nestler, John E.; Myers, Evan; Legro, Richard S.

2016-01-01

Context: Experimental evidence supports a relevance of vitamin D (VitD) for reproduction; however, data in humans are sparse and inconsistent. Objective: To assess the relationship of VitD status with ovulation induction (OI) outcomes in women with polycystic ovary syndrome (PCOS). Design: A retrospective cohort. Setting: Secondary analysis of randomized controlled trial data. Participants: Participants in the Pregnancy in PCOS I (PPCOS I) randomized controlled trial (n = 540) met the National Institutes of Health diagnostic criteria for PCOS. Interventions: Serum 25OHD levels were measured in stored sera. Main Outcome Measures: Primary, live birth (LB); secondary, ovulation and pregnancy loss after OI. Results: Likelihood for LB was reduced by 44% for women if the 25OHD level was < 30 ng/mL (<75 nmol/L; odds ratio [OR], 0.58 [0.35–0.92]). Progressive improvement in the odds for LB was noted at thresholds of ≥38 ng/mL (≥95 nmol/L; OR, 1.42 [1.08–1.8]), ≥40 ng/mL (≥100 nmol/L; OR, 1.51 [1.05–2.17]), and ≥45 ng/mL (≥112.5 nmol/L; OR, 4.46 [1.27–15.72]). On adjusted analyses, VitD status was an independent predictor of LB and ovulation after OI. Conclusions: In women with PCOS, serum 25OHD was an independent predictor of measures of reproductive success after OI. Our data identify reproductive thresholds for serum 25OHD that are higher than recommended for the nonpregnant population. PMID:27186859

Rheumatic and musculoskeletal features of Whipple disease: a report of 29 cases.

PubMed

Meunier, Marine; Puechal, Xavier; Hoppé, Emmanuel; Soubrier, Martin; Dieudé, Philippe; Berthelot, Jean Marie; Caramaschi, Paola; Gottenberg, Jacques-Eric; Gossec, Laure; Morel, Jacques; Maury, Emilie; Wipff, Julien; Kahan, André; Allanore, Yannick

2013-12-01

Whipple disease is a rare infection caused by Tropheryma whipplei. Although patients commonly complain of osteoarticular involvement, musculoskeletal manifestations have been poorly described. We report cases of Whipple disease with rheumatic symptoms and describe their clinical presentation, modes of diagnosis, and outcomes. This retrospective multicenter study included patients with Whipple disease diagnosed and referenced between 1977 and 2011 in 10 rheumatology centers in France and Italy. Twenty-nine patients were included. The median age was 55 years. The median time to diagnosis from first symptoms was 5 years. Polyarthritis was the most frequent presentation (20/29), and was most often chronic, intermittent (19/29), seronegative (22/23), and nonerosive (22/29). In all cases, the symptoms had led to incorrect diagnosis of inflammatory rheumatic disease and immunosuppressants, including biotherapy, were prescribed in most cases (24/29) without success. The diagnosis of Whipple disease was made by histological analysis, molecular biology tests, or both in 21%, 36%, and 43% of the cases, respectively. Duodenal biopsies were performed in most cases (86%). Synovial biopsies were performed in 18% of cases, but all contributed to diagnosis. The clinical outcomes after antibiotic therapy were good for all patients. Polyarthritis is the main feature observed in cases of Whipple disease; it is seronegative and associated with general and gastrointestinal symptoms. The molecular analysis of duodenal tissue and/or other tissues remains the method of choice to confirm the diagnosis. Reducing the time to diagnosis is important because severe late systemic and fatal forms of the disease may occur.

Clinicopathologic characteristics, treatment outcomes, and prognostic factors of primary thoracic soft tissue sarcoma: A multicenter study of the Anatolian Society of Medical Oncology (ASMO)

PubMed Central

Unal, Olcun Umit; Oztop, Ilhan; Yasar, Nurgul; Urakci, Zuhat; Ozatli, Tahsin; Bozkurt, Oktay; Sevinc, Alper; Gunaydin, Yusuf; Yapar Taskoylu, Burcu; Arpaci, Erkan; Ulas, Arife; Kodaz, Hilmi; Tonyali, Onder; Avci, Nilufer; Aksoy, Asude; Yilmaz, Ahmet Ugur

2015-01-01

Background Soft tissue sarcomas (STSs) are rare malignant tumors of embryogenic mesoderm origin. Primary thoracic STSs account for a small percentage of all STSs and limited published information is available. This study aimed to identify the prognostic factors for thoracic STSs and evaluate the disease's clinical outcomes. Methods The medical records of 109 patients with thoracic STSs who were treated between 2003 and 2013 were retrospectively reviewed. Patients' survival rates were analyzed and potential prognostic factors evaluated. Results The median follow-up period was 29 months (range: 1–121 months). STSs were most frequently localized on the chest wall (n = 42; 38.5%) and lungs (n = 42; 38.5%). The most common histological types were malignant fibrous histiocytoma (n = 23; 21.1%), liposarcoma (n = 17; 15.6%), and leiomyosarcoma (n = 16; 14.7%). The median survival time of all patients was 40.3 months (95% confidence interval, 14.22–66.37 months), with one and five-year survival rates of 93.4% and 63.5%, respectively. Univariate analysis of all groups revealed that metastatic stage, unresectability, tumor diameter of >10 cm, tumor location other than the chest wall, and grade 3 diseases were predictable of poor survival. However, only grade 3 diseases and tumor location other than the chest wall were confirmed by multivariate analysis as poor prognostic factors. Conclusions Primary thoracic STSs are rarely seen malignant tumors. Our results indicated that patients with low-grade tumors and those localized on the chest wall often experienced better survival outcomes. PMID:26273340

Revisiting Hemicraniectomy: Late Decompressive Hemicraniectomy for Malignant Middle Cerebral Artery Stroke and the Role of Infarct Growth Rate

PubMed Central

Akhtar, Naveed; Salam, Abdul; Alboudi, Ayman; Kamran, Kainat; Ahmed, Arsalan; Khan, Rabia A.; Mirza, Mohsin K.; Inshasi, Jihad

2017-01-01

Objective and Methods. The outcome in late decompressive hemicraniectomy in malignant middle cerebral artery stroke and the optimal timings of surgery has not been addressed by the randomized trials and pooled analysis. Retrospective, multicenter, cross-sectional study to measure outcome following DHC under 48 or over 48 hours using the modified Rankin scale [mRS] and dichotomized as favorable ≤4 or unfavorable >4 at three months. Results. In total, 137 patients underwent DHC. Functional outcome analyzed as mRS 0–4 versus mRS 5-6 showed no difference in this split between early and late operated on patients [P = 0.140] and mortality [P = 0.975]. Multivariate analysis showed that age ≥ 55 years, MCA with additional infarction, septum pellucidum deviation ≥1 cm, and uncal herniation were independent predictors of poor functional outcome at three months. In the “best” multivariate model, second infarct growth rate [IGR2] >7.5 ml/hr, MCA with additional infarction, and patients with temporal lobe involvement were independently associated with surgery under 48 hours. Both first infarct growth rate [IGR1] and second infarct growth rate [IGR2] were nearly double [P < 0.001] in patients with early surgery [under 48 hours]. Conclusions. The outcome and mortality in malignant middle cerebral artery stroke patients operated on over 48 hours of stroke onset were comparable to those of patients operated on less than 48 hours after stroke onset. Our data identifies IGR, temporal lobe involvement, and middle cerebral artery with additional infarct as independent predictors for early surgery. PMID:28409051

Revisiting Hemicraniectomy: Late Decompressive Hemicraniectomy for Malignant Middle Cerebral Artery Stroke and the Role of Infarct Growth Rate.

PubMed

Kamran, Saadat; Akhtar, Naveed; Salam, Abdul; Alboudi, Ayman; Kamran, Kainat; Ahmed, Arsalan; Khan, Rabia A; Mirza, Mohsin K; Inshasi, Jihad; Shuaib, Ashfaq

2017-01-01

Objective and Methods. The outcome in late decompressive hemicraniectomy in malignant middle cerebral artery stroke and the optimal timings of surgery has not been addressed by the randomized trials and pooled analysis. Retrospective, multicenter, cross-sectional study to measure outcome following DHC under 48 or over 48 hours using the modified Rankin scale [mRS] and dichotomized as favorable ≤4 or unfavorable >4 at three months. Results. In total, 137 patients underwent DHC. Functional outcome analyzed as mRS 0-4 versus mRS 5-6 showed no difference in this split between early and late operated on patients [ P = 0.140] and mortality [ P = 0.975]. Multivariate analysis showed that age ≥ 55 years, MCA with additional infarction, septum pellucidum deviation ≥1 cm, and uncal herniation were independent predictors of poor functional outcome at three months. In the "best" multivariate model, second infarct growth rate [IGR2] >7.5 ml/hr, MCA with additional infarction, and patients with temporal lobe involvement were independently associated with surgery under 48 hours. Both first infarct growth rate [IGR1] and second infarct growth rate [IGR2] were nearly double [ P < 0.001] in patients with early surgery [under 48 hours]. Conclusions. The outcome and mortality in malignant middle cerebral artery stroke patients operated on over 48 hours of stroke onset were comparable to those of patients operated on less than 48 hours after stroke onset. Our data identifies IGR, temporal lobe involvement, and middle cerebral artery with additional infarct as independent predictors for early surgery.

Decompressive Hemicraniectomy for Malignant Middle Cerebral Artery Stroke: South Asian Experience.

PubMed

Kamran, Saadat; Akhtar, Naveed; Salam, Abdul; Alboudi, Ayman; Rashid, Hiba; Kamran, Kainat; Khan, Rabia Ali; Mirza, Mohsin Khalid; Ahmed, Arsalan; Own, Ahmed M A; Al Rukun, Sohail; Inshasi, Jihad; Deleu, Dirk; Al Sulaiti, Ghanim; Shuaib, Ashfaq

2017-10-01

The randomized trials showed improved outcome and reduced mortality in malignant middle cerebral artery (MMCA) undergoing Decompressive hemicraniectomy (DHC) within 48 hours of stroke onset. Despite high prevalence of stroke, especially in younger individuals, high and short-term mortality from stroke in South Asian and Middle East, there is little published data on DHC in patients with MMCA stroke. This is a retrospective, multicenter cross-sectional study to measure outcome following DHC using the modified Rankin Scale (mRS) and dichotomized as favorable (mRS ≤ 4) or unfavorable (mRS > 4), at 3 months. In total, 137 patients underwent DHC. At 90 days, mortality was 16.8%; 61.3% of patients survived with an mRS of 4 or less and 38.7% had an mRS greater than 4. Age (55 years), diabetes (P = .004), hypertension (P = .021), pupillary abnormality (P = .048), uncal herniation (P = .007), temporal lobe involvement (P = .016), additional infarction (MCA + anterior cerebral artery, posterior cerebral artery) (P = .001), and infarction growth rates (P = .025) were significantly higher in patients with unfavorable prognosis in univariate analysis. Multivariate analysis showed age, additional infarction, septum pellucidum deviation greater than 1 cm, and uncal herniation to be associated with a significantly poor prognosis. Time to surgery had no impact on outcome (P = .109). Similar to the results of the studies from the West, DHC Improves functional outcome in predominantly South Asian patients with MMCA Stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Clinical Factors and Disease Course Related to Diagnostic Delay in Korean Crohn's Disease Patients: Results from the CONNECT Study.

PubMed

Moon, Chang Mo; Jung, Sung-Ae; Kim, Seong-Eun; Song, Hyun Joo; Jung, Yunho; Ye, Byong Duk; Cheon, Jae Hee; Kim, You Sun; Kim, Young-Ho; Kim, Joo Sung; Han, Dong Soo

2015-01-01

Diagnostic delay frequently occurs in Crohn's disease (CD) patients because of diagnostic limitations. However, diagnostic delay and its related factors remain poorly defined. Therefore, we aimed to identify the predictors associated with diagnostic delay and to evaluate the impact of diagnostic delay on clinical course in a Korean CD patient cohort. We performed a multicenter retrospective analysis of 1,047 CD patients registered in the Crohn's Disease Clinical Network and Cohort study in Korea. The mean interval of diagnostic delay was 16.0 ± 33.1 months. Multivariate analysis showed that older age at diagnosis (≥40 years) (p = 0.014), concomitant upper gastrointestinal (UGI) disease (p = 0.012) and penetrating disease behavior at diagnosis (p = 0.001) were positively associated with long diagnostic delay (≥18 months). During the longitudinal follow-up, long diagnostic delay was independently predictive of further development of intestinal stenosis (hazard ratio [HR], 1.43; 95% confidence interval [CI], 1.07-1.93; p = 0.017), internal fistulas (HR, 1.62; 95% CI, 1.12-2.33; p = 0.011), and perianal fistulas (HR, 1.38; 95% CI, 1.06-1.80; p = 0.016). However, as for the risk of abscess formation, bowel perforation, and CD-related abdominal surgery, no significant association with diagnostic delay was observed. Older age at diagnosis, UGI involvement, and penetrating behavior are associated with long diagnostic delay in Korean CD patients. Moreover, diagnostic delay is associated with an increased risk of CD-related complications such as intestinal stenosis, internal fistulas, and perianal fistulas.

Clinical efficacy of adalimumab in Crohn's disease: a real practice observational study in Japan.

PubMed

Takeshima, Fuminao; Yoshikawa, Daisuke; Higashi, Syuntaro; Morisaki, Tomohito; Oda, Hidetoshi; Ikeda, Maho; Machida, Haruhisa; Matsushima, Kayoko; Minami, Hitomi; Akazawa, Yuko; Yamaguchi, Naoyuki; Ohnita, Ken; Isomoto, Hajime; Ueno, Masato; Nakao, Kazuhiko

2016-07-29

There are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. We conducted a Japanese multicenter retrospective observational study. We evaluated patients with CD who were treated with ADA at 11 medical institutions in Japan to investigate the clinical efficacy of remission up to 52 weeks and the associated factors to achieve remission with a CD Activity Index (CDAI) < 150. The effects of preventing postoperative recurrence were also evaluated. In 62 patients, the remission rates were 33.9, 74.2, 75.8, 77.4, and 66.1 % at 0, 4, 12, 26, and 52 weeks, respectively. Although 10 patients discontinued treatment due to primary nonresponse, secondary nonresponse, or adverse events, the ongoing treatment rate at 52 weeks was 83.9 %. Comparison of remission and non-remission on univariate analysis identified colonic type and baseline CDAI value as significant associated factors (P < 0.05). In 16 patients who received ADA to prevent postoperative recurrence, the clinical remission maintenance rate was 93.8 % and the mucosal healing rate was 64.3 % during a mean postoperative follow-up period of 32.3 months. ADA effectively induced remission and prevented postoperative recurrence in patients with CD in a real practice setting.

Initial fluid resuscitation following adjusted body weight dosing is associated with improved mortality in obese patients with suspected septic shock.

PubMed

Taylor, Stephanie Parks; Karvetski, Colleen H; Templin, Megan A; Heffner, Alan C; Taylor, Brice T

2018-02-01

The optimal initial fluid resuscitation strategy for obese patients with septic shock is unknown. We evaluated fluid resuscitation strategies across BMI groups. Retrospective analysis of 4157 patients in a multicenter activation pathway for treatment of septic shock between 2014 and 2016. 1293 (31.3%) patients were obese (BMI≥30). Overall, higher BMI was associated with lower mortality, however this survival advantage was eliminated in adjusted analyses. Patients with higher BMI received significantly less fluid per kilogram at 3h than did patients with lower BMI (p≤0.001). In obese patients, fluid given at 3h mimicked a dosing strategy based on actual body weight (ABW) in 780 (72.2%), adjusted body weight (AdjBW) in 95 (8.8%), and ideal body weight (IBW) in 205 (19.0%). After adjusting for condition- and treatment-related variables, dosing based on AdjBW was associated with improved mortality compared to ABW (OR 0.45; 95% CI [0.19, 1.07]) and IBW (OR 0.29; 95% CI [0.11,0.74]). Using AdjBW to calculate initial fluid resuscitation volume for obese patients with suspected shock may improve outcomes compared to other weight-based dosing strategies. The optimal fluid dosing strategy for obese patients should be a focus of future prospective research. Copyright © 2017 Elsevier Inc. All rights reserved.

[Compliance with the PECARN and AEP guidelines in diagnostic approach of mild head trauma in patients younger than 24 months old].

PubMed

Velasco, R; Arribas, M; Valencia, C; Zamora, N; Fernández, S M; Lobeiras, A; Urbaneja, E; Garrote, R; González, L; Benito, H

2015-09-01

Mild head trauma is a frequent complaint in Pediatric Emergency Departments. Several guidelines have been published in the last few years. However, significant variability can be appreciated in terms of the demand for image tests. The aim of this study is to determine the level of compliance with PECARN and AEP guidelines in the management of patients younger than 24 months old in four different hospitals. A multicenter retrospective study was conducted on patients presenting with mild head trauma between October 1st, 2011 and March 31st, 2013 in the Emergency Departments of four hospitals. In the analysis of the results obtained, only one of the four hospitals complied with the AEP guidelines in more than 50% of the patients. The other three hospitals had a level of compliance lower than 50%. Management was more suitable according to PECARN guidelines, with 3 of the 4 hospitals having a level of compliance greater than 50%. However, the best compliance achieved by a hospital was only of 70%. The study shows that the level of compliance with guidelines for management of mild head trauma in patients younger than 24 months old is low. Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

Correlation between MGMT promoter methylation and response to temozolomide-based therapy in neuroendocrine neoplasms: an observational retrospective multicenter study.

PubMed

Campana, Davide; Walter, Thomas; Pusceddu, Sara; Gelsomino, Fabio; Graillot, Emmanuelle; Prinzi, Natalie; Spallanzani, Andrea; Fiorentino, Michelangelo; Barritault, Marc; Dall'Olio, Filippo; Brighi, Nicole; Biasco, Guido

2018-06-01

Temozolomide (TEM) based therapy has been reported being effective in the treatment of metastatic neuroendocrine neoplasms (NEN), with response rates ranging from 30 to 70%. Among patients affected by advanced glioblastoma or melanoma and treated with TEM, loss of tumoral O6-methylguanine DNA methyltransferase (MGMT) is correlated with improved survival. In NEN patients, the role of MGMT deficiency in predicting clinical outcomes of TEM treatment is still under debate. In this study we evaluated 95 patients with advanced NENs undergoing treatment with TEM-based therapy. MGMT promoter methylation status was evaluated with two techniques: methylation specific-polymerase chain reaction or pyrosequencing. Treatment with TEM-based therapy was associated with an overall response rate of 27.4% according to RECIST criteria (51.8% of patients with and 17.7% without MGMT promoter methylation). Response to therapy, progression free survival and overall survival was correlated to MGMT status at univariate and multivariate analysis. Methylation of MGMT promoter could be a strong predictive factor of objective response and an important prognostic factor of a longer PFS and OS. According to our results, MGMT methylation status, evaluated with methylation specific-polymerase chain reaction or pyrosequencing, should have an important role in patients with metastatic NENs, in order to guide therapeutic options. These results need further confirmation with prospective studies.

Status of diabetes treatment in Japanese adults: an analysis of the 2009 Japan Society of Ningen Dock database.

PubMed

Takahashi, Eiko; Moriyama, Kengo; Yamakado, Minoru

2014-01-01

The Japan Diabetes Society (JDS) has recommended target levels of glycemic control based on guidelines for the management of diabetes mellitus (DM). The Japan Society of Ningen Dock created a database of subjects receiving annual health examinations nationwide. Using this database, we evaluated the efficacy of current treatment for patients with DM based on the JDS recommendations. This multicenter, retrospective study was conducted using data obtained from 21 institutions across Japan. In order to assess the level of glycemic control in the Japanese population, we analyzed previously obtained measurements of HbA1c in 7,180 patients 20 to 79 years of age (mean age: 57.9 ± 8.7 years, 6,007 men and 1,173 women) taking DM medications. According to the JDS guidelines, 44.7% of the patients fell into the good glycemic control group, with an HbA1c level of <7.0% while 22.4% were classified into the poor glycemic control group, with an HbA1c level of ≥ 8.0%. The control of other arteriosclerosis risk factors deteriorated as the glycemic control deteriorated. Lifestyle factors were strongly found to be associated with glycemic control in the patients receiving DM treatment. Aggressive lifestyle modification is needed to improve glycemic control in patients with DM.

Personalized ovarian stimulation for assisted reproductive technology: study design considerations to move from hype to added value for patients.

PubMed

Mol, Ben W; Bossuyt, Patrick M; Sunkara, Sesh K; Garcia Velasco, Juan A; Venetis, Christos; Sakkas, Denny; Lundin, Kersti; Simón, Carlos; Taylor, Hugh S; Wan, Robert; Longobardi, Salvatore; Cottell, Evelyn; D'Hooghe, Thomas

2018-06-01

Although most medical treatments are designed for the average patient with a one-size-fits-all-approach, they may not benefit all. Better understanding of the function of genes, proteins, and metabolite, and of personal and environmental factors has led to a call for personalized medicine. Personalized reproductive medicine is still in its infancy, without clear guidance on treatment aspects that could be personalized and on trial design to evaluate personalized treatment effect and benefit-harm balance. While the rationale for a personalized approach often relies on retrospective analyses of large observational studies or real-world data, solid evidence of superiority of a personalized approach will come from randomized trials comparing outcomes and safety between a personalized and one-size-fits-all strategy. A more efficient, targeted randomized trial design may recruit only patients or couples for which the personalized approach would differ from the previous, standard approach. Multiple monocenter studies using the same study protocol (allowing future meta-analysis) might reduce the major center effect associated with multicenter studies. In certain cases, single-arm observational studies can generate the necessary evidence for a personalized approach. This review describes each of the main segments of patient care in assisted reproductive technologies treatment, addressing which aspects could be personalized, emphasizing current evidence and relevant study design. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Transjugular intrahepatic portosystemic shunt creation for cirrhotic portal hypertension is well tolerated among patients with portal vein thrombosis.

PubMed

Merola, Jonathan; Fortune, Brett E; Deng, Yanhong; Ciarleglio, Maria; Amirbekian, Smbat; Chaudhary, Noami; Shanbhogue, Alampady; Ayyagari, Rajasekhara; Rodriguez-Davalos, Manuel I; Teperman, Lewis; Charles, Hearns W; Sigal, Samuel H

2018-06-01

Portal vein thrombosis (PVT) develops in cirrhotic patients because of stagnation of blood flow. Transjugular intrahepatic portosystemic shunt (TIPS) creates a low-resistance conduit that restores portal venous patency and blood flow. The effect of PVT on transplant-free survival in cirrhotic patients undergoing TIPS creation was evaluated. A multicenter, retrospective cohort study of patients who underwent TIPS creation for cirrhotic portal hypertension was carried out. A Cox model with propensity score adjustment was developed to evaluate the effect of PVT on 90-day and 3-year transplant-free survival. A subgroup analysis examining mortality of those with superior and inferior PVT was also carried out. A total of 252 consecutive TIPS creations were assessed, including 65 in patients with PVT. Survival of patients with high Model for End-stage Liver Disease scores (≥18) and PVT was not statistically different compared with patients with low Model for End-stage Liver Disease scores (<18) and no PVT at 90 days (P=0.46) and 3 years (P=0.42). Those with superior PVT had improved 90-day and 3-year survival both compared with patients with a inferior PVT and those without a PVT (P<0.01, all cases). The presence of PVT does not impair the prognosis of patients following TIPS creation, particularly in patients with superior portal occlusion.

Diffusion-weighted MR imaging of upper abdominal organs at different time points: Apparent diffusion coefficient normalization using a reference organ.

PubMed

Song, Ji Soo; Kwak, Hyo Sung; Byon, Jung Hee; Jin, Gong Yong

2017-05-01

To compare the apparent diffusion coefficient (ADC) of upper abdominal organs acquired at different time points, and to investigate the usefulness of normalization. We retrospectively evaluated 58 patients who underwent three rounds of magnetic resonance (MR) imaging including diffusion-weighted imaging of the upper abdomen. MR examinations were performed using three different 3.0 Tesla (T) and one 1.5T systems, with variable b value combinations and respiratory motion compensation techniques. The ADC values of the upper abdominal organs from three different time points were analyzed, using the ADC values of the paraspinal muscle (ADC psm ) and spleen (ADC spleen ) for normalization. Intraclass correlation coefficients (ICC) and comparison of dependent ICCs were used for statistical analysis. The ICCs of the original ADC and ADC psm showed fair to substantial agreement, while ADC spleen showed substantial to almost perfect agreement. The ICC of ADC spleen of all anatomical regions showed less variability compared with that of the original ADC (P < 0.005). Normalized ADC using the spleen as a reference organ significantly decreased variability in measurement of the upper abdominal organs in different MR systems at different time points and could be regarded as an imaging biomarker for future multicenter, longitudinal studies. 5 J. MAGN. RESON. IMAGING 2017;45:1494-1501. © 2016 International Society for Magnetic Resonance in Medicine.

EORTC, ISCL, and USCLC consensus recommendations for the treatment of primary cutaneous CD30-positive lymphoproliferative disorders: lymphomatoid papulosis and primary cutaneous anaplastic large-cell lymphoma*

PubMed Central

Pfaltz, Katrin; Vermeer, Maarten H.; Cozzio, Antonio; Ortiz-Romero, Pablo L.; Bagot, Martine; Olsen, Elise; Kim, Youn H.; Dummer, Reinhard; Pimpinelli, Nicola; Whittaker, Sean; Hodak, Emmilia; Cerroni, Lorenzo; Berti, Emilio; Horwitz, Steve; Prince, H. Miles; Guitart, Joan; Estrach, Teresa; Sanches, José A.; Duvic, Madeleine; Ranki, Annamari; Dreno, Brigitte; Ostheeren-Michaelis, Sonja; Knobler, Robert; Wood, Gary; Willemze, Rein

2011-01-01

Primary cutaneous CD30+ lymphoproliferative disorders (CD30+ LPDs) are the second most common form of cutaneous T-cell lymphomas and include lymphomatoid papulosis and primary cutaneous anaplastic large-cell lymphoma. Despite the anaplastic cytomorphology of tumor cells that suggest an aggressive course, CD30+ LPDs are characterized by an excellent prognosis. Although a broad spectrum of therapeutic strategies has been reported, these have been limited mostly to small retrospective cohort series or case reports, and only very few prospective controlled or multicenter studies have been performed, which results in a low level of evidence for most therapies. The response rates to treatment, recurrence rates, and outcome have not been analyzed in a systematic review. Moreover, international guidelines for staging and treatment of CD30+ LPDs have not yet been presented. Based on a literature analysis and discussions, recommendations were elaborated by a multidisciplinary expert panel of the Cutaneous Lymphoma Task Force of the European Organization for Research and Treatment of Cancer, the International Society for Cutaneous Lymphomas, and the United States Cutaneous Lymphoma Consortium. The recommendations represent the state-of-the-art management of CD30+ LPDs and include definitions for clinical endpoints as well as response criteria for future clinical trials in CD30+ LPDs. PMID:21841159

[Interpretation on Chinese surgeons' consensus opinion for the definition of gastric stump cancer (version 2018)].

PubMed

Gao, Zhidong; Jiang, Kewei; Ye, Yingjiang; Wang, Shan

2018-05-25

Gastric stump cancer(GSC) is defined as newly developed remnant stomach cancer following gastrectomy. This definition initially referred to carcinoma detected in the remnant stomach more than 5 years after the primary surgery for a benign disease. Subsequently, this timeframe was extended to 10 years after the primary surgery for a malignant disease. Recently, the concept of "carcinoma in the remnant stomach(CRS)" proposed by the Japanese Gastric Cancer Association was introduced in China. The new definition encompasses all carcinomas arising in the remnant stomach following gastrectomy, irrespective of the histology of the primary lesion, extent of resection, or reconstruction method. It includes all carcinoma types that have developed in the remnant stomach, such as newly developed cancer, recurrent cancer, remaining cancer, and multiple cancers. Considering the current diagnosis and treatment status of gastric cancer in China, if CRS is to be used as a direct equivalent to GSC in clinical practice, confusion may arise concerning disease identification and diagnosis. Following several discussion rounds, a meta-analysis of the literatures at home and abroad, and a multicenter national retrospective study with a large sample population, the "Chinese surgeons' consensus opinion for the definition of gastric stump cancer (version 2018)" was completed. By reviewing the detailed evidence-based medicine supporting the consensus document, this paper aims to assist clinical diagnosis and enhance future academic exchange.

Pain and disability determine treatment modality for older patients with adult scoliosis, while deformity guides treatment for younger patients.

PubMed

Bess, Shay; Boachie-Adjei, Oheneba; Burton, Doug; Cunningham, Matthew; Shaffrey, Chris; Shelokov, Alexis; Hostin, Richard; Schwab, Frank; Wood, Kirkham; Akbarnia, Behrooz

2009-09-15

Multi-center, retrospective review. Identify age associated clinical and radiographic features correlating with AS treatment. Little information exists about factors determining treatment for adult scoliosis (AS). Existing studies have not evaluated age stratified differences. Multicenter, retrospective review of 290 patients treated for AS. Patients divided into operative (OP) or nonoperative (NON), and age stratified into 3 groups (G1 = <50 years, G2 = 50-65 years, G3 = >65 years). Demographic and spinopelvic radiographic parameters evaluated. Health-related quality of life (HRQL) measures included SRS-22, Oswestry Disability Index (ODI), visual analog pain scale. Treatment groups (OP, n = 137; NON, n = 153) demonstrated similar age (OP = 52.7 years; NON = 55.5 years; P > 0.05) and comorbidities. OP had larger thoracic curves than NON (OP = 51 degrees, NON = 45 degrees; P < 0.05). OP had worse HRQL scores than NON (SRS = 2.95 vs. 3.12, P < 0.05; ODI = 33.4 vs. 28.7, P < 0.05; visual analog pain scale = 6.9 vs. 5.6, P < 0.05, respectively). Age stratification of OP demonstrated larger curves in G1 and G2 versus G3, progressively worsening sagittal imbalance in older age groups, and worse HRQL scores in G3 versus G1 and G2. Age stratification of NON demonstrated worsening sagittal imbalance with age, however, other radiographic values and HRQL scores were similar between all NON age groups. Treatment stratification of age groups demonstrated G1-OP had greater deformity than G1-NON (mean thoracic curve: G1-OP = 53 degrees, G1-NON = 43 degrees; P < 0.05) but similar HRQL values. Whereas G2 and G3-OP had similar radiographic coronal and sagittal values as G2 and G3-NON, but worse HRQL scores. Counter to previous reports, age, comorbidities, and sagittal balance did not influence treatment modality for AS. Operative treatment for younger patients was driven by increased coronal plane deformity. Conversely, pain and disability mandated treatment for older patients, independent of radiographic measures. These findings suggest that AS patients do not become uniformly disabled with age, and that disability can not be solely predicted by radiographic findings. These data should be considered when considering treatment for AS.

Sweat Chloride as A Biomarker of CFTR Activity: Proof of Concept and Ivacaftor Clinical Trial Data

PubMed Central

Accurso, Frank J.; Van Goor, Fredrick; Zha, Jiuhong; Stone, Anne J.; Dong, Qunming; Ordonez, Claudia L.; Rowe, Steven M.; Clancy, John Paul; Konstan, Michael W.; Hoch, Heather E.; Heltshe, Sonya L.; Ramsey, Bonnie W.; Campbell, Preston W.; Ashlock, Melissa A.

2014-01-01

Background We examined data from a Phase 2 trial {NCT00457821 } of ivacaftor, a CFTR potentiator, in cystic fibrosis (CF) patients with a G551D mutation to evaluate standardized approaches to sweat chloride measurement and to explore the use of sweat chloride and nasal potential difference (NPD) to estimate CFTR activity. Methods Sweat chloride and NPD were secondary endpoints in this placebo-controlled, multicenter trial. Standardization of sweat collection, processing, and analysis was employed for the first time.. Sweat chloride and chloride ion transport (NPD) were integrated into a model of CFTR activity. Results Within-patient sweat chloride determinations showed sufficient precision to detect differences between dose-groups and assess ivacaftor treatment effects. Analysis of changes in sweat chloride and NPD demonstrated that patients treated with ivacaftor achieved CFTR activity equivalent to approximately 35%–40% of normal. Conclusions Sweat chloride is useful in multicenter trials as a biomarker of CFTR activity and to test the effect of CFTR potentiators. PMID:24660233

Sweat chloride as a biomarker of CFTR activity: proof of concept and ivacaftor clinical trial data.

PubMed

Accurso, Frank J; Van Goor, Fredrick; Zha, Jiuhong; Stone, Anne J; Dong, Qunming; Ordonez, Claudia L; Rowe, Steven M; Clancy, John Paul; Konstan, Michael W; Hoch, Heather E; Heltshe, Sonya L; Ramsey, Bonnie W; Campbell, Preston W; Ashlock, Melissa A

2014-03-01

We examined data from a Phase 2 trial {NCT00457821} of ivacaftor, a CFTR potentiator, in cystic fibrosis (CF) patients with aG551D mutation to evaluate standardized approaches to sweat chloride measurement and to explore the use of sweat chloride and nasal potential difference (NPD) to estimate CFTR activity. Sweat chloride and NPD were secondary endpoints in this placebo-controlled, multicenter trial. Standardization of sweat collection, processing,and analysis was employed for the first time. Sweat chloride and chloride ion transport (NPD) were integrated into a model of CFTR activity. Within-patient sweat chloride determinations showed sufficient precision to detect differences between dose-groups and assess ivacaftor treatment effects. Analysis of changes in sweat chloride and NPD demonstrated that patients treated with ivacaftor achieved CFTR activity equivalent to approximately 35%–40% of normal. Sweat chloride is useful in multicenter trials as a biomarker of CFTR activity and to test the effect of CFTR potentiators.

Recurrent Thrombotic Events after Discontinuation of Vitamin K Antagonist Treatment for Splanchnic Vein Thrombosis: A Multicenter Retrospective Cohort Study

PubMed Central

Riva, Nicoletta; Ageno, Walter; Poli, Daniela; Testa, Sophie; Rupoli, Serena; Santoro, Rita; Lerede, Teresa; Piana, Antonietta; Carpenedo, Monica; Nicolini, Alberto; Ferrini, Piera Maria; Martini, Giuliana; Mangione, Catello; Contino, Laura; Bonfanti, Carlo; Gresele, Paolo; Tosetto, Alberto

2015-01-01

It is generally recommended that patients with splanchnic vein thrombosis (SVT) should receive a minimum of 3 months of anticoagulant treatment. However, little information is available on the long-term risk of recurrent thrombotic events. The aim of this study was to evaluate the risk of venous and arterial thrombosis after discontinuation of vitamin K antagonist (VKA) in SVT patients. Retrospective information from a cohort of SVT patients treated with VKA and followed by 37 Italian Anticoagulation Clinics, up to June 2013, was collected. Only patients who discontinued VKA and did not receive any other anticoagulant drug were enrolled in this study. Thrombotic events during follow-up were centrally adjudicated. Ninety patients were included: 33 unprovoked SVT, 27 SVT secondary to transient risk factors, and 30 with permanent risk factors. During a median follow-up of 1.6 years, 6 venous and 1 arterial thrombosis were documented, for an incidence of 3.3/100 patient-years (pt-y). The recurrence rate was highest in the first year after VKA discontinuation (8.2/100'pt-y) and in patients with permanent risk factors (10.2/100'pt-y). Liver cirrhosis significantly increased the risk of recurrence. In conclusion, the rate of recurrent vascular complications after SVT is not negligible, at least in some patient subgroups. PMID:26508913

Recurrent Thrombotic Events after Discontinuation of Vitamin K Antagonist Treatment for Splanchnic Vein Thrombosis: A Multicenter Retrospective Cohort Study.

PubMed

Riva, Nicoletta; Ageno, Walter; Poli, Daniela; Testa, Sophie; Rupoli, Serena; Santoro, Rita; Lerede, Teresa; Piana, Antonietta; Carpenedo, Monica; Nicolini, Alberto; Ferrini, Piera Maria; Martini, Giuliana; Mangione, Catello; Contino, Laura; Bonfanti, Carlo; Gresele, Paolo; Tosetto, Alberto

2015-01-01

It is generally recommended that patients with splanchnic vein thrombosis (SVT) should receive a minimum of 3 months of anticoagulant treatment. However, little information is available on the long-term risk of recurrent thrombotic events. The aim of this study was to evaluate the risk of venous and arterial thrombosis after discontinuation of vitamin K antagonist (VKA) in SVT patients. Retrospective information from a cohort of SVT patients treated with VKA and followed by 37 Italian Anticoagulation Clinics, up to June 2013, was collected. Only patients who discontinued VKA and did not receive any other anticoagulant drug were enrolled in this study. Thrombotic events during follow-up were centrally adjudicated. Ninety patients were included: 33 unprovoked SVT, 27 SVT secondary to transient risk factors, and 30 with permanent risk factors. During a median follow-up of 1.6 years, 6 venous and 1 arterial thrombosis were documented, for an incidence of 3.3/100 patient-years (pt-y). The recurrence rate was highest in the first year after VKA discontinuation (8.2/100'pt-y) and in patients with permanent risk factors (10.2/100'pt-y). Liver cirrhosis significantly increased the risk of recurrence. In conclusion, the rate of recurrent vascular complications after SVT is not negligible, at least in some patient subgroups.

Impact of Clostridium difficile-associated diarrhea on acute care length of stay, hospital costs, and readmission: A multicenter retrospective study of inpatients, 2009-2011.

PubMed

Magee, Glenn; Strauss, Marcie E; Thomas, Sheila M; Brown, Harold; Baumer, Dorothy; Broderick, Kelly C

2015-11-01

The recent epidemiologic changes of Clostridium difficile-associated diarrhea (CDAD) have resulted in substantial economic burden to U.S. acute care hospitals. Past studies evaluating CDAD-attributable costs have been geographically and demographically limited. Here, we describe CDAD-attributable burden in inpatients, overall, and in vulnerable subpopulations from the Premier hospital database, a large, diverse cohort with a wide range of high-risk subgroups. Discharges from the Premier database were retrospectively analyzed to assess length of stay (LOS), total inpatient costs, readmission, and inpatient mortality. Patients with CDAD had significantly worse outcomes than matched controls in terms of total LOS, rates of intensive care unit (ICU) admission, and inpatient mortality. After adjustment for risk factors, patients with CDAD had increased odds of inpatient mortality, total and ICU LOS, costs, and odds of 30-, 60- and 90-day all-cause readmission versus non-CDAD patients. CDAD-attributable costs were higher in all studied vulnerable subpopulations, which also had increased odds of 30-, 60- and 90-day all-cause readmission than those without CDAD. Given the significant economic impact CDAD has on hospitals, prevention of initial episodes and targeted therapy to prevent recurrences in vulnerable patients are essential to decrease the overall burden to hospitals. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Patients' Characteristics, Histopathological Findings, and Tumor Stage in Different Types of Malignant Melanoma: A Retrospective Multicenter Study.

PubMed

Farahmand, Ali-Mohammad; Ehsani, Amir-Hoshang; Mirzaei, Mojtaba; Mohsenian, Maryam; Ghanadan, Alireza

2017-05-01

Cutaneous malignant melanoma (CMM) is currently the most fatal of skin cancers accounting for 50000 deaths annually. Five distinct melanomas are described histopathologically: superficial spreading, lentigo maligna, nodular, acral lentiginous and mucosal melanoma. The aim of this study was to investigate the characteristics of patients with various types of malignant melanoma and evaluate histopathological findings. In this retrospective study, we obtained our data from the records of 111 patients with melanoma. Biopsied specimens were collected and re-evaluated. Demographic information and histopathological findings were noted. SPSS 16 was used for analyzing data. Chi-square and one-way ANOVA was conducted for comparing categorical and numerical variables respectively. The mean age of patients was 59.33±14.68 years old. Most common melanoma type was acral lentiginous (40.5%), followed by nodular (35.1%) and mucosal (10.8%). The highest tumor thickness was viewed in nodular melanoma followed by mucosal melanoma. The highest rate of metastasis, microsatellitosis, perineural invasion and Clark level of the invasion were reported in nodular and acral lentiginous respectively. The most frequent rate of ulceration and vascular invasion was reported in mucosal melanoma. Distribution of melanoma types varies largely in different regions. Lack of classic presentations in some types necessitate specific public education about warning signs. Histopathological and pathological characteristics in melanoma can aid in better staging and management of the tumor.

Treatment of coexistent psoriasis and lupus erythematosus.

PubMed

Varada, Sowmya; Gottlieb, Alice B; Merola, Joseph F; Saraiya, Ami R; Tintle, Suzanne J

2015-02-01

The coexistence of psoriasis and lupus erythematosus (LE) is rare. Anecdotal evidence suggests that anti-tumor necrosis factor alfa (TNF-α) agents may be efficacious in LE, although their use is commonly avoided in this disease because of concern for lupus flare. We sought to describe the epidemiology, serologic findings, and therapeutic choices in patients with coexistent psoriasis/psoriatic arthritis and LE and to determine the risk of lupus flares with TNF-α inhibitors. We performed a retrospective multicenter study of patients given the diagnoses of psoriasis (or psoriatic arthritis) and lupus erythematosus (systemic LE or cutaneous LE, including either subacute cutaneous LE or discoid LE) at 2 academic tertiary-care centers. A total of 96 patients with a mean age of 56 years was included. We report higher-than-expected rates of white race and psoriatic arthritis. One clinical lupus flare was observed in a patient receiving a TNF-α inhibitor, resulting in an incidence of 0.92% lupus flares per patient-year of TNF-α inhibitor use. Retrospective chart review, small sample size, and limited documentation. Anti-TNF-α agents, ustekinumab, and abatacept may be valid treatment options for patients with concomitant LE and psoriasis. Clinical lupus flares in LE patients treated with TNF-α inhibitors were infrequent. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

The Utility of Low-Dose Aripiprazole for the Treatment of Bipolar II and Bipolar NOS Depression.

PubMed

Kelly, Tammas; Lieberman, Daniel Z

2017-02-01

Despite initial reports of efficacy in bipolar depression, multicenter trials did not show aripiprazole to be better than placebo, possibly because the doses used were too high, leading to lower efficacy and high dropout rates. This study evaluated the effects of low-dose aripiprazole. Extensive clinical experience has suggested that doses beyond 5 mg are rarely efficacious. Data were gathered from patients with bipolar II or bipolar not otherwise specified depression using a retrospective chart review. Efficacy was assessed with the Clinical Global Impression-Improvement score. Patients who had at least 2 trials of aripiprazole were included in a retrospective off-on-off-on experimental design. All patients were on other medications when aripiprazole was started. Patients were treated with doses of 1 to 5 mg. On average, patients were rated improved or very much improved compared with baseline. Sixteen of 211 patients worsened or experienced no change. Forty-four patients (21%) discontinued due to adverse effects. The group of patients who underwent off-on-off-on trials experienced statistically significant improvement when they started and restarted aripiprazole, and statistically significant worsening when they discontinued it. When treating bipolar II or bipolar not otherwise specified depression, low doses of aripiprazole, 5 mg or less, may be more effective and better tolerated than higher ones. Clinicians should start treatment with a very low dose and give patients time to respond.

LIS1-associated classic lissencephaly: A retrospective, multicenter survey of the epileptogenic phenotype and response to antiepileptic drugs.

PubMed

Herbst, Saskia M; Proepper, Christiane R; Geis, Tobias; Borggraefe, Ingo; Hahn, Andreas; Debus, Otfried; Haeussler, Martin; von Gersdorff, Gero; Kurlemann, Gerhard; Ensslen, Matthias; Beaud, Nathalie; Budde, Joerg; Gilbert, Michael; Heiming, Ralf; Morgner, Rita; Philippi, Heike; Ross, Sophia; Strobl-Wildemann, Gertrud; Muelleder, Kerstin; Vosschulte, Paul; Morris-Rosendahl, Deborah J; Schuierer, Gerhard; Hehr, Ute

2016-04-01

Patients with LIS1-associated classic lissencephaly typically present with severe psychomotor retardation and drug-resistant epilepsy within the first year. To analyze the epileptogenic phenotype and response to antiepileptic therapy in LIS1-associated classic lissencephaly. Retrospective evaluation of 22 patients (8 months-24 years) with genetically and radiologically confirmed LIS1-associated classic lissencephaly in 16 study centers. All patients in our cohort developed drug-resistant epilepsy. In 82% onset of seizures was noted within the first six months of life, most frequently with infantile spasms. Later in infancy the epileptogentic phenotype became more variable and included different forms of focal seizures as well generalized as tonic-clonic seizures, with generalized tonic-clonic seizures being the predominant type. Lamotrigine and valproate were rated most successful with good or partial response rates in 88-100% of the patients. Both were evaluated significantly better than levetiracetam (p<0.05) and sulthiame (p<0.01) in the neuropediatric assessment and better than levetiracetam, sulthiame (p<0.05) and topiramate (p<0.01) in the family survey. Phenobarbital and vigabatrin achieved good or partial response in 62-83% of the patients. Our findings suggest that patients with LIS1-associated lissencephaly might benefit most from lamotrigine, valproate, vigabatrin or phenobarbital. Copyright © 2015 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

Laparoscopic repair of perforated peptic ulcer: patch versus simple closure.

PubMed

Abd Ellatif, M E; Salama, A F; Elezaby, A F; El-Kaffas, H F; Hassan, A; Magdy, A; Abdallah, E; El-Morsy, G

2013-01-01

Laparoscopic correction of perforated peptic ulcer (PPU) has become an accepted way of management. Patch omentoplasty stayed for decades the main method of repair. The goal of the present study was to evaluate whether laparoscopic simple repair of PPU is as safe as patch omentoplasty. Since June 2005, 179 consecutive patients of PPU were treated by laparoscopic repair at our centers. We conducted a retrospective chart review in December 2012. Group I (patch group) included patients who were treated with standard patch omentoplasty. Group II (non-patch group) included patients who received simple repair without patch. From June 2007 to Dec. 2012, 179 consecutive patients of PPU who were treated by laparoscopic repair at our centers were enrolled in this multi-center retrospective study. 108 patients belong to patch group. While 71 patients were treated with laparoscopic simple repair. Operative time was significantly shorter in group II (non patch) (p = 0.01). No patient was converted to laparotomy. There was no difference in age, gender, ASA score, surgical risk (Boey's) score, and incidence of co-morbidities. Both groups were comparable in terms of hospital stay, time to resume oral intake, postoperative complications and surgical outcomes. Laparoscopic simple repair of PPU is a safe procedure compared with the traditional patch omentoplasty in presence of certain selection criteria. Copyright © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

[Management of ophthalmologic emergencies in general emergency departments: A retrospective multicenter study].

PubMed

Jeannin, A; Mouriaux, F; Mortemousque, B

2016-09-01

The growing shortage of working ophthalmologists makes it more difficult for the patient to access ophthalmological care, especially in an emergent context. These patients are thus taken to general emergency departments for ophthalmologic problems. To observe the epidemiological characteristics of ophthalmic patients in general emergency centers and question the emergency physicians on their practice of ophthalmology. A retrospective epidemiological study was conducted in the emergency departments of Rennes, Lorient and Saint-Brieuc over a period of three months. The demographic characteristics, diagnoses, examinations and procedures performed, opinions obtained from ophthalmologists and patient outcomes were studied. A qualitative study by online questionnaire was sent to the emergency physicians. Seven hundred and eighty-one patients were included, mainly men (68%) under 35 years (45%). The most frequent diagnosis was extra-ocular foreign body (32%). An ophthalmologist opinion was requested in 79% within 24hours. The online questionnaire was sent to 74 emergency physicians: 92% of them were willing to participate in additional training, 90% had sufficient means to practice ophthalmology in the emergency room. Emergency physicians could handle the most frequent ophthalmological emergencies, extra-ocular foreign bodies and minor trauma, with adapted material resources, autonomy for these conditions, and willingness for ophthalmologic training. Protocols could be proposed in order to optimize the care of these patients. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Progression of undiagnosed cutaneous lymphoma after anti-tumor necrosis factor-alpha therapy.

PubMed

Martinez-Escala, Maria Estela; Posligua, Alba L; Wickless, Heather; Rutherford, Audrey; Sable, Kimberly A; Rubio-Gonzalez, Belen; Zhou, Xiaolong A; Kaplan, Jason B; Pro, Barbara; Choi, Jaehyuk; Querfeld, Christiane; Rosen, Steven T; Guitart, Joan

2018-06-01

Cutaneous lymphoma diagnosed after anti-tumor necrosis factor-α therapy (anti-TNF-α) has been reported in the literature, yet a clear link between both events remains elusive. To review our experience with cutaneous lymphoma diagnosed during or after the use of anti-TNF-α therapies. This is a multicenter retrospective study and a literature review. A total of 22 cases, including 20 cutaneous T-cell lymphomas (CTCLs) and 2 cutaneous B-cell lymphomas, were identified. In the CTCL group, 75% of the patients received an anti-TNF-α agent for a presumed inflammatory skin condition. Mycosis fungoides and Sézary syndrome were the most common subtypes of CTCL diagnosed. Advanced disease (stage IIB to IVA) was commonly seen at time of diagnosis and required aggressive therapy, including stem cell transplant in 3 patients; 2 patients in whom cutaneous B-cell lymphomas was diagnosed had an indolent course. A total of 31 cases were gathered from a literature search. This is a retrospective study. Our findings suggest that the disease of most of the identified patients was misdiagnosed as psoriasis or eczema; therefore, a comprehensive morphologic and molecular review of skin biopsy specimens and peripheral blood samples should be considered before initiation of anti-TNF-α therapy in patients with poorly defined dermatitis or atypical presentations of psoriasis. Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Multicenter Analysis of Midterm Clinical Outcomes of Arthroscopic Labral Repair in the Hip: Minimum 5-Year Follow-up.

PubMed

Hevesi, Mario; Krych, Aaron J; Johnson, Nick R; Redmond, John M; Hartigan, David E; Levy, Bruce A; Domb, Benjamin G

2018-02-01

The technique of hip arthroscopic surgery is advancing and becoming more commonly performed. However, most current reported results are limited to short-term follow-up, and therefore, the durability of the procedure is largely unknown. To perform a multicenter analysis of mid-term clinical outcomes of arthroscopic hip labral repair and determine the risk factors for patient outcomes. Cohort study; Level of evidence, 3. Prospectively collected data of primary hip arthroscopic labral repair performed at 4 high-volume centers between 2008 and 2011 were reviewed retrospectively. Patients were assessed preoperatively and postoperatively with the visual analog scale (VAS), modified Harris Hip Score (mHHS), and Hip Outcome Score-Sports-Specific Subscale (HOS-SSS) at a minimum of 5 years' follow-up. Factors including age, body mass index (BMI), Tönnis grade, and cartilage grade were analyzed in relation to outcome scores, and revision rates were determined. Failure was defined as subsequent ipsilateral hip surgery, including revision arthroscopic surgery and open hip surgery. A total of 303 patients (101 male, 202 female) with a mean age of 32.0 years (range, 10.7-58.9 years) were followed for a mean of 5.7 years (range, 5.0-7.9 years). Patients achieved mean improvements in VAS of 3.5 points, mHHS of 20.1 points, and HOS-SSS of 29.3 points. Thirty-seven patients (12.2%) underwent revision arthroscopic surgery, and 12 (4.0%) underwent periacetabular osteotomy, resurfacing, or total hip arthroplasty during the study period. Patients with a BMI >30 kg/m 2 had a mean mHHS score 9.5 points lower and a mean HOS-SSS score 15.9 points lower than those with a BMI ≤30 kg/m 2 ( P < .01). Patients aged >35 years at surgery had a mean mHHS score 4.5 points lower and a HOS-SSS score 6.7 points lower than those aged ≤35 years ( P = .03). Patients with Tönnis grade 2 radiographs demonstrated a 12.5-point worse mHHS score ( P = .02) and a 23.0-point worse HOS-SSS score ( P < .01) when compared with patients with Tönnis grade 0. Patients demonstrated significant improvements in VAS, mHHS, and HOS-SSS scores after arthroscopic labral repair. However, those with Tönnis grade 2 changes preoperatively, BMI >30 kg/m 2 , and age >35 years at the time of surgery demonstrated significantly decreased mHHS and HOS-SSS scores at final follow-up.

Volatility and Growth in Populations of Rural Associations

ERIC Educational Resources Information Center

Wollebaek, Dag

2010-01-01

This article uses unique community-level data aggregated from censuses of associations to analyze growth and volatility in rural populations of grassroots associations. A qualitative comparative analysis (QCA) shows that the two main paths to growth were (1) centralization in polycephalous (multicentered) municipalities and (2) population growth…

An innovative enterostomal therapy nurse model of community wound care delivery: a retrospective cost-effectiveness analysis.

PubMed

Harris, Connie; Shannon, Ronald

2008-01-01

A Canadian specialty nursing association identified the necessity to examine the role and impact of enterostomal (ET) nursing in Canada. We completed a retrospective analysis of the cost-effectiveness and benefits of ET nurse-driven resources for the treatment of acute and chronic wounds in the community. This was a multicenter retrospective pragmatic chart audit of 3 models of nursing care utilizing 4 community nursing agencies and 1 specialty company owned and operated by ET nurses. An analysis was completed using quantitative methods to evaluate healing outcomes, nursing costs, and cost-effectiveness. Kaplan-Meier estimates were calculated to determine the average time to 100% healing of acute and chronic wounds and total nursing visit costs for treatment in a community setting. Average direct nursing costs related to management of each wound were determined by number of nursing visits and related reimbursement for each visit. A Monte Carlo simulation method was used to help account for costs and benefits in determination of cost-effectiveness between caring groups and the uncertainty from variation between patients and wounds. Three hundred sixty chronic wounds and 54 acute surgical wound charts were audited. Involvement of a registered nurse (RN) with ET or advanced wound ostomy skills (AWOS) in community-level chronic and acute wound care was associated with lower overall costs mainly due to reduced time to 100% closure of the wound and reduced number of nursing visits. The differences in health benefits and total costs of nursing care between the ET/AWOS and a hybrid group that includes interventions developed by an ET nurse and followed by general visiting nurses that could include both RNs and registered practical nurses is an expected reduction in healing times of 45 days and an expected cost difference of $5927.00 per chronic wound treated. When outcomes were broken into ET/AWOS involvement categories for treatment of chronic wounds, there was a significantly faster time to 100% closure at a lower mean cost as the ET/AWOS involvement increased in the case. For acute wound treatment, the differences in health benefits and total costs between the ET/AWOS and a hybrid nursing care model were an expected reduction in healing times of 95 days and an expected cost difference of $9578.00 per acute wound treated. Again, there was a significant difference in healing times and reduced mean cost as the ET/AWOS became more involved in the treatment. The financial benefit to the Ontario Ministry of Health and Long-Term Care is estimated to increase as the involvement of nurses with ET/AWOS specialty training increases. The greater the involvement both directly and indirectly of an ET/AWOS nurse in the management of wounds, the greater the savings and the shorter the healing times.

77 FR 12598 - Notice Correction; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice Correction; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) The Federal... project titled, ``A multi-center international hospital-based case-control study of lymphoma in Asia (Asia...

The effectiveness and safety of amisulpride in Chinese patients with schizophrenia: An 8‐week, prospective, open‐label, multicenter, single‐arm study

PubMed Central

Liang, Ying; Cao, Changan; Zhu, Cheng; Wang, Chuanyue; Zhang, Congpei; Dong, Fang; Yang, Fude; Deng, Hong; Yu, Jingjie; Tang, Jisheng; Su, Lei; Xin, Limin; Hong, Ling; Gao, Minglong; Tang, Muni; Xie, Shiping; Lu, Shuiping; Liu, Tiebang; Xu, Xiaojin; Wang, Xijin; Li, Xuanzi; Wang, Xueyi; Li, Yi; Zhang, Yong; Chen, Zhiyu

2016-01-01

Abstract Introduction This study evaluated the effectiveness and safety of amisulpride in Chinese schizophrenia patients. Methods A multicenter, single‐arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Results A total of 316 patients were enrolled; 295 were included in the effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Nine patients discontinued treatment because of adverse events. Discussion Amisulpride had clinical effectiveness and was relatively well tolerated in Chinese patients with schizophrenia. PMID:27020720

ECLAMC Study: prevalence patterns of hypospadias in South America: multi-national analysis over a 24-year period

PubMed Central

Fernández, Nicolás; Pérez, Jaime; Monterrey, Pedro; Poletta, Fernando A.; Bägli, Darius J.; Lorenzo, Armando J.; Zarante, Ignacio

2017-01-01

ABSTRACT Objective To evaluate prevalence trends of hypospadias in South-America it is essential to perform multicenter and multinational studies with the same methodology. Herein we present systematic data as part of an international multicenter initiative evaluating congenital malformations in South America over a 24-year period. Materials and Methods A nested case-control study was conducted using the Latin American Collaborative Study of Congenital Malformations (ECLAMC), between January 1989 and December 2012. Cases were stratified as isolated (IH) and non-isolated hypospadias (NIH). Global prevalence was calculated and discriminated by country. Associations between birth weight and gestational age, and NIH distribution by associated abnormality and severity of hypospadias, were analyzed. Results A total of 159 hospitals from six countries participated, reporting surveillance on 4.020.384 newborns. A total of 4.537 hypospadias cases were detected, with a global prevalence of 11.3/10.000 newborns. Trend analyses showed in Chile, Brazil and Uruguay a statistically significant increase in prevalence. Analysis of severity and associated anomalies did not to find an association for distal cases, but did for proximal (RR=1.64 [95% CI=1.33-2.03]). Conclusion This is one of only a few Latin American multicenter studies reporting on the epidemiology of hypospadias in South America in the last two decades. Our data adds to evidence suggesting an increase in some countries in the region at different times. There were also variations in prevalence according to severity. This study adds to literature describing associated anomalies at a hospital-based level. PMID:27802003

ECLAMC Study: Prevalence patterns of hypospadias in South America: Multi-national analysis over a 24-year period.

PubMed

Fernández, Nicolás; Pérez, Jaime; Monterrey, Pedro; Poletta, Fernando A; Bägli, Darius J; Lorenzo, Armando J; Zarante, Ignacio

2017-01-01

To evaluate prevalence trends of hypospadias in South-America it is essential to perform multicenter and multinational studies with the same methodology. Herein we present systematic data as part of an international multicenter initiative evaluating congenital malformations in South America over a 24-year period. A nested case-control study was conducted using the Latin American Collaborative Study of Congenital Malformations (ECLAMC), between January 1989 and December 2012. Cases were stratified as isolated (IH) and non-isolated hypospadias (NIH). Global prevalence was calculated and discriminated by country. Associations between birth weight and gestational age, and NIH distribution by associated abnormality and severity of hypospadias, were analyzed. A total of 159 hospitals from six countries participated, reporting surveillance on 4.020.384 newborns. A total of 4.537 hypospadias cases were detected, with a global prevalence of 11.3/10.000 newborns. Trend analyses showed in Chile, Brazil and Uruguay a statistically significant increase in prevalence. Analysis of severity and associated anomalies did not to find an association for distal cases, but did for proximal (RR=1.64 [95% CI=1.33-2.03]). This is one of only a few Latin American multicenter studies reporting on the epidemiology of hypospadias in South America in the last two decades. Our data adds to evidence suggesting an increase in some countries in the region at different times. There were also variations in prevalence according to severity. This study adds to literature describing associated anomalies at a hospital-based level. Copyright® by the International Brazilian Journal of Urology.

Inter-vender and test-retest reliabilities of resting-state functional magnetic resonance imaging: Implications for multi-center imaging studies.

PubMed

An, Hyeong Su; Moon, Won-Jin; Ryu, Jae-Kyun; Park, Ju Yeon; Yun, Won Sung; Choi, Jin Woo; Jahng, Geon-Ho; Park, Jang-Yeon

2017-12-01

This prospective multi-center study aimed to evaluate the inter-vendor and test-retest reliabilities of resting-state functional magnetic resonance imaging (RS-fMRI) by assessing the temporal signal-to-noise ratio (tSNR) and functional connectivity. Study included 10 healthy subjects and each subject was scanned using three 3T MR scanners (GE Signa HDxt, Siemens Skyra, and Philips Achieva) in two sessions. The tSNR was calculated from the time course data. Inter-vendor and test-retest reliabilities were assessed with intra-class correlation coefficients (ICCs) derived from variant component analysis. Independent component analysis was performed to identify the connectivity of the default-mode network (DMN). In result, the tSNR for the DMN was not significantly different among the GE, Philips, and Siemens scanners (P=0.638). In terms of vendor differences, the inter-vendor reliability was good (ICC=0.774). Regarding the test-retest reliability, the GE scanner showed excellent correlation (ICC=0.961), while the Philips (ICC=0.671) and Siemens (ICC=0.726) scanners showed relatively good correlation. The DMN pattern of the subjects between the two sessions for each scanner and between three scanners showed the identical patterns of functional connectivity. The inter-vendor and test-retest reliabilities of RS-fMRI using different 3T MR scanners are good. Thus, we suggest that RS-fMRI could be used in multicenter imaging studies as a reliable imaging marker. Copyright © 2017 Elsevier Inc. All rights reserved.

Multilevel mixed effects parametric survival models using adaptive Gauss-Hermite quadrature with application to recurrent events and individual participant data meta-analysis.

PubMed

Crowther, Michael J; Look, Maxime P; Riley, Richard D

2014-09-28

Multilevel mixed effects survival models are used in the analysis of clustered survival data, such as repeated events, multicenter clinical trials, and individual participant data (IPD) meta-analyses, to investigate heterogeneity in baseline risk and covariate effects. In this paper, we extend parametric frailty models including the exponential, Weibull and Gompertz proportional hazards (PH) models and the log logistic, log normal, and generalized gamma accelerated failure time models to allow any number of normally distributed random effects. Furthermore, we extend the flexible parametric survival model of Royston and Parmar, modeled on the log-cumulative hazard scale using restricted cubic splines, to include random effects while also allowing for non-PH (time-dependent effects). Maximum likelihood is used to estimate the models utilizing adaptive or nonadaptive Gauss-Hermite quadrature. The methods are evaluated through simulation studies representing clinically plausible scenarios of a multicenter trial and IPD meta-analysis, showing good performance of the estimation method. The flexible parametric mixed effects model is illustrated using a dataset of patients with kidney disease and repeated times to infection and an IPD meta-analysis of prognostic factor studies in patients with breast cancer. User-friendly Stata software is provided to implement the methods. Copyright © 2014 John Wiley & Sons, Ltd.

Serum reference interval of ARCHITECT alpha-fetoprotein in healthy Chinese Han adults: Sub-analysis of a prospective multi-center study.

PubMed

Yan, Cunling; Yang, Jia; Wei, Lianhua; Hu, Jian; Song, Jiaqi; Wang, Xiaoqin; Han, Ruilin; Huang, Ying; Zhang, Wei; Soh, Andrew; Beshiri, Agim; Fan, Zhuping; Zheng, Yijie; Chen, Wei

2018-02-01

Alpha-fetoprotein (AFP) has been widely used in clinical practice for decades. However, large-scale survey of serum reference interval for ARCHITECT AFP is still absent in Chinese population. This study aimed to measure serum AFP levels in healthy Chinese Han subjects, which is a sub-analysis of an ongoing prospective, cross-sectional, multi-center study (ClinicalTrials.gov Identifier: NCT03047603). This analysis included a total of 530 participants (41.43±12.14years of age on average, 48.49% males), enrolled from 5 regional centers. Serum AFP level was measured by ARCHITECT immunoassay. Statistical analysis was performed using SAS 9.4 and R software. AFP distribution did not show significant correlation with age or sex. The overall median and interquartile range of AFP was 2.87 (2.09, 3.83) ng/mL. AFP level did not show a trend of increasing with age. The new reference interval was 2.0-7.07ng/mL (LOQ- 97.5th percentiles). The reference interval for ARCHITECT AFP is updated with the data of adequate number of healthy Han adults. This new reference interval is more practical and applicable in Chinese adults. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Incidence and risk factors of postoperative pneumonia following cancer surgery in adult patients with selected solid cancer: results of "Cancer POP" study.

PubMed

Jung, Jiwon; Moon, Song Mi; Jang, Hee-Chang; Kang, Cheol-In; Jun, Jae-Bum; Cho, Yong Kyun; Kang, Seung-Ji; Seo, Bo-Jeong; Kim, Young-Joo; Park, Seong-Beom; Lee, Juneyoung; Yu, Chang Sik; Kim, Sung-Han

2018-01-01

The aim of this study was to investigate the incidence and risk factors of postoperative pneumonia (POP) within 1 year after cancer surgery in patients with the five most common cancers (gastric, colorectal, lung, breast cancer, and hepatocellular carcinoma [HCC]) in South Korea. This was a multicenter and retrospective cohort study performed at five nationwide cancer centers. The number of cancer patients in each center was allocated by the proportion of cancer surgery. Adult patients were randomly selected according to the allocated number, among those who underwent cancer surgery from January to December 2014 within 6 months after diagnosis of cancer. One-year cumulative incidence of POP was estimated using Kaplan-Meier analysis. An univariable Cox's proportional hazard regression analysis was performed to identify risk factors for POP development. As a multivariable analysis, confounders were adjusted using multiple Cox's PH regression model. Among the total 2000 patients, the numbers of patients with gastric cancer, colorectal cancer, lung cancer, breast cancer, and HCC were 497 (25%), 525 (26%), 277 (14%), 552 (28%), and 149 (7%), respectively. Overall, the 1-year cumulative incidence of POP was 2.0% (95% CI, 1.4-2.6). The 1-year cumulative incidences in each cancer were as follows: lung 8.0%, gastric 1.8%, colorectal 1.0%, HCC 0.7%, and breast 0.4%. In multivariable analysis, older age, higher Charlson comorbidity index (CCI) score, ulcer disease, history of pneumonia, and smoking were related with POP development. In conclusions, the 1-year cumulative incidence of POP in the five most common cancers was 2%. Older age, higher CCI scores, smoker, ulcer disease, and previous pneumonia history increased the risk of POP development in cancer patients. © 2017 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Health-related Quality of Life After Radical Cystectomy: A Cross-sectional Study With Matched-pair Analysis on Ileal Conduit vs Ileal Orthotopic Neobladder Diversion.

PubMed

Cerruto, Maria Angela; D'Elia, Carolina; Siracusano, Salvatore; Saleh, Omar; Gacci, Mauro; Cacciamani, Giovanni; De Marco, Vincenzo; Porcaro, Antonio Benito; Balzarro, Matteo; Niero, Mauro; Lonardi, Cristina; Iafrate, Massimo; Bassi, Pierfrancesco; Imbimbo, Ciro; Racioppi, Marco; Talamini, Renato; Ciciliato, Stefano; Serni, Sergio; Carini, Marco; Verze, Paolo; Artibani, Walter

2017-10-01

To examine the different and health-related quality of life (HR-QoL) outcomes between ileal conduit (IC) and ileal orthotopic neobladder (IONB) in patients who underwent radical cystectomy (RC), by using validated self-reported cancer-specific instruments. This retrospective, cross-sectional, multicenter cohort study included 148 and 171 patients with either IC or IONB. HR-QoL was evaluated with Quality of Life Core Questionnaire and bladder module (BLM)-30 European Organisation for Research and Treatment of Cancer questionnaires. Baseline HR-QoL scores were dichotomized at the median to give "good" or "poor" score profiles. A matched-pair analysis compared HR-QoL aspects between 79 IC patients and 79 IONB patients. At univariate analysis IONB resulted favorable for physical functioning, emotional functioning, cognitive functioning (CF), fatigue, dyspnea, appetite loss, constipation (CO), and abdominal bloating flatulence (AB). At multivariate analyses, IONB showed better scores for emotional functioning (85 vs 79, P = .023), CF (93 vs 85, P <.001), CO (16 vs 31, P <.001), and AB (12 vs 25, P <.001). A significant worsening of sexual and urinary function was observed for IONB patients in the long-term. At matched-pair analysis, global health status was similar (65 vs 62, P = .385). Significantly better scores were observed in the IONB group for the following items: CF (P = .007), fatigue (P = .003), pain (P = .019), dyspnea (P = .016), CO (P = .001), and AB (P = .00). IONB and IC after RC were similar in terms of global health status. IONB provides better results in some aspects of HR-QoL related to bowel function, but a worsening of urinary and sexual functions. Further randomized controlled trials are needed to confirm these data. Copyright © 2017 Elsevier Inc. All rights reserved.

The extent of intestinal failure-associated liver disease in patients referred for intestinal rehabilitation is associated with increased mortality: an analysis of the pediatric intestinal failure consortium database.

PubMed

Javid, Patrick J; Oron, Assaf P; Duggan, Christopher; Squires, Robert H; Horslen, Simon P

2017-09-05

The advent of regional multidisciplinary intestinal rehabilitation programs has been associated with improved survival in pediatric intestinal failure. Yet, the optimal timing of referral for intestinal rehabilitation remains unknown. We hypothesized that the degree of intestinal failure-associated liver disease (IFALD) at initiation of intestinal rehabilitation would be associated with overall outcome. The multicenter, retrospective Pediatric Intestinal Failure Consortium (PIFCon) database was used to identify all subjects with baseline bilirubin data. Conjugated bilirubin (CBili) was used as a marker for IFALD, and we stratified baseline bilirubin values as CBili<2 mg/dL, CBili 2-4 mg/dL, and CBili>4 mg/dL. The association between baseline CBili and mortality was examined using Cox proportional hazards regression. Of 272 subjects in the database, 191 (70%) children had baseline bilirubin data collected. 38% and 28% of patients had CBili >4 mg/dL and CBili <2 mg/dL, respectively, at baseline. All-cause mortality was 23%. On univariate analysis, mortality was associated with CBili 2-4 mg/dL, CBili >4 mg/dL, prematurity, race, and small bowel atresia. On regression analysis controlling for age, prematurity, and diagnosis, the risk of mortality was increased by 3-fold for baseline CBili 2-4 mg/dL (HR 3.25 [1.07-9.92], p=0.04) and 4-fold for baseline CBili >4 mg/dL (HR 4.24 [1.51-11.92], p=0.006). On secondary analysis, CBili >4 mg/dL at baseline was associated with a lower chance of attaining enteral autonomy. In children with intestinal failure treated at intestinal rehabilitation programs, more advanced IFALD at referral is associated with increased mortality and decreased prospect of attaining enteral autonomy. Early referral of children with intestinal failure to intestinal rehabilitation programs should be strongly encouraged. Treatment Study, Level III. Copyright © 2017 Elsevier Inc. All rights reserved.

The prognosis of infective endocarditis treated with biological valves versus mechanical valves: A meta-analysis

PubMed Central

Tao, Ende; Wan, Li; Wang, WenJun; Luo, YunLong; Zeng, JinFu; Wu, Xia

2017-01-01

Objective Surgery remains the primary form of treatment for infective endocarditis (IE). However, it is not clear what type of prosthetic valve provides a better prognosis. We conducted a meta-analysis to compare the prognosis of infective endocarditis treated with biological valves to cases treated with mechanical valves. Methods Pubmed, Embase and Cochrane databases were searched from January 1960 to November 2016.Randomized controlled trials, retrospective cohorts and prospective studies comparing outcomes between biological valve and mechanical valve management for infective endocarditis were analyzed. The Newcastle-Ottawa Scale(NOS) was used to evaluate the quality of the literature and extracted data, and Stata 12.0 software was used for the meta-analysis. Results A total of 11 publications were included; 10,754 cases were selected, involving 6776 cases of biological valves and 3,978 cases of mechanical valves. The all-cause mortality risk of the biological valve group was higher than that of the mechanical valve group (HR = 1.22, 95% CI 1.03 to 1.44, P = 0.023), as was early mortality (RR = 1.21, 95% CI 1.02 to 1.43, P = 0.033). The recurrence of endocarditis (HR = 1.75, 95% CI 1.26 to 2.42, P = 0.001), as well as the risk of reoperation (HR = 1.79, 95% CI 1.15 to 2.80, P = 0.010) were more likely to occur in the biological valve group. The incidence of postoperative embolism was less in the biological valve group than in the mechanical valve group, but this difference was not statistically significant (RR = 0.90, 95% CI 0.76 to 1.07, P = 0.245). For patients with prosthetic valve endocarditis (PVE), there was no significant difference in survival rates between the biological valve group and the mechanical valve group (HR = 0.91, 95% CI 0.68 to 1.21, P = 0.520). Conclusion The results of our meta-analysis suggest that mechanical valves can provide a significantly better prognosis in patients with infective endocarditis. There were significant differences in the clinical features of patients receiving a biological valve compared to patients receiving a mechanical valve. A large, multicenter retrospective study included in our meta-analysis suggested that any mortality risk of the biological valve group was significant higher than that of the mechanical valve group. However, the risk was no different after risk was adjusted. So, we thought the reason for this result may be related to the characteristics of the patient rather than valve dysfunction. It is still necessary to future randomized studies to verify this conclusion. PMID:28407024

The Significance of Tumoral ERCC1 Status in Patients With Locally Advanced Cervical Cancer Treated With Chemoradiation Therapy: A Multicenter Clinicopathologic Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Doll, Corinne M., E-mail: Corinne.Doll@albertahealthservices.ca; Aquino-Parsons, Christina; Pintilie, Melania

2013-03-01

Purpose: ERCC1 (excision repair cross-complementation group 1) expression has been shown to be a molecular marker of cisplatin resistance in many tumor sites, but has not been well studied in cervical cancer patients. The purpose of this study was to measure tumoral ERCC1 in patients with locally advanced cervical cancer treated with chemoradiation therapy (CRT) in a large multicenter cohort, and to correlate expression with clinical outcome parameters. Methods and Materials: A total of 264 patients with locally advanced cervical cancer, treated with curative-intent radical CRT from 3 major Canadian cancer centers were evaluated. Pretreatment formalin-fixed, paraffin-embedded tumor specimens weremore » retrieved, and tissue microarrays were constructed. Tumoral ERCC1 (FL297 antibody) was measured using AQUA (R) technology. Statistical analysis was performed to determine the significance of clinical factors and ERCC1 status with progression-free survival (PFS) and overall survival (OS) at 5 years. Results: The majority of patients had International Federation of Gynecology and Obstetrics (FIGO) stage II disease (n=119, 45%); median tumor size was 5 cm. OS was associated with tumor size (HR 1.16, P=.018), pretreatment hemoglobin status (HR 2.33, P=.00027), and FIGO stage. In addition, tumoral ERCC1 status (nuclear to cytoplasmic ratio) was associated with PFS (HR 2.33 [1.05-5.18], P=.038) and OS (HR 3.13 [1.27-7.71], P=.013). ERCC1 status was not significant on multivariate analysis when the model was adjusted for the clinical factors: for PFS (HR 1.49 [0.61-3.6], P=.38); for OS (HR 2.42 [0.94-6.24] P=.067). Conclusions: In this large multicenter cohort of locally advanced cervical cancer patients treated with radical CRT, stage, tumor size, and pretreatment hemoglobin status were significantly associated with PFS and OS. ERCC1 status appears to have prognostic impact on univariate analysis in these patients, but was not independently associated with outcome on multivariate analysis.« less

Electronic medical record integration with a database for adult congenital heart disease: Early experience and progress in automating multicenter data collection.

PubMed

Broberg, Craig S; Mitchell, Julie; Rehel, Silven; Grant, Andrew; Gianola, Ann; Beninato, Peter; Winter, Christiane; Verstappen, Amy; Valente, Anne Marie; Weiss, Joseph; Zaidi, Ali; Earing, Michael G; Cook, Stephen; Daniels, Curt; Webb, Gary; Khairy, Paul; Marelli, Ariane; Gurvitz, Michelle Z; Sahn, David J

2015-10-01

The adoption of electronic health records (EHR) has created an opportunity for multicenter data collection, yet the feasibility and reliability of this methodology is unknown. The aim of this study was to integrate EHR data into a homogeneous central repository specifically addressing the field of adult congenital heart disease (ACHD). Target data variables were proposed and prioritized by consensus of investigators at five target ACHD programs. Database analysts determined which variables were available within their institutions' EHR and stratified their accessibility, and results were compared between centers. Data for patients seen in a single calendar year were extracted to a uniform database and subsequently consolidated. From 415 proposed target variables, only 28 were available in discrete formats at all centers. For variables of highest priority, 16/28 (57%) were available at all four sites, but only 11% for those of high priority. Integration was neither simple nor straightforward. Coding schemes in use for congenital heart diagnoses varied and would require additional user input for accurate mapping. There was considerable variability in procedure reporting formats and medication schemes, often with center-specific modifications. Despite the challenges, the final acquisition included limited data on 2161 patients, and allowed for population analysis of race/ethnicity, defect complexity, and body morphometrics. Large-scale multicenter automated data acquisition from EHRs is feasible yet challenging. Obstacles stem from variability in data formats, coding schemes, and adoption of non-standard lists within each EHR. The success of large-scale multicenter ACHD research will require institution-specific data integration efforts. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Application of the cultured epidermal autograft "JACE(®") for treatment of severe burns: Results of a 6-year multicenter surveillance in Japan.

PubMed

Matsumura, Hajime; Matsushima, Asako; Ueyama, Masashi; Kumagai, Norio

2016-06-01

In the 1970s, Green et al. developed a method that involved culturing keratinocyte sheets and used for treatment of burns. Since then, the take rate of cultured epidermal autograft (CEA) onto fascia, granulation tissue, or allografts has been extensively reported, while that on an artificial dermis in a large case series is not. Moreover, the contribution of CEA to patient survival has not been analyzed in a multicenter study. We conducted a 6-year multicenter surveillance on the application of the CEA "JACE(®") for treatment of burns >30% total body surface area (TBSA) across 118 Japanese hospitals. This surveillance included 216 patients and 718 graft sites for efficacy analysis. The CEA take rate at 4 weeks after grafting was evaluated, and safety was monitored until 52 weeks. In addition, the survival curve obtained in this study and the data obtained from the Tokyo Burn Unit Association (TBUA) were compared. The mean CEA take rates at week 4 were 66% (sites) and 68% (patients), and the rate on the artificial dermis was 65% for 226 sites. CEA application combined with wide split-thickness auto or patch autograft increased the CEA take rate. On comparison with the data obtained from the TBUA, which included data on individuals with burns of the same severity, CEA application was found to contribute to patient survival until 7 weeks after burn. We reported the take rate of CEA based on a 6-year multicenter surveillance. From our results, we found that the application of CEA is a useful treatment for the patients with extensive burns. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Out-of-hospital opioid therapy of palliative care patients with "acute dyspnoea": a retrospective multicenter investigation.

PubMed

Wiese, Christoph H R; Barrels, Utz E; Graf, Bernhard M; Hanekop, Gerd G

2009-01-01

Prehospital emergency physicians (EP) are often confronted with the acute care of palliative care patients. Dyspnoea is a frequent acute symptom and its causes often differ from the generally known emergency medical causes. Till now, there have been no relevant concepts for emergency care of palliative care patients for their specific symptoms. Over a 24-month period, the authors retrospectively investigated all out-of-hospital emergency medical services for palliative care patients with acute dyspnoea at four emergency physician support points. The evaluation of these services was followed retrospectively on the basis of the therapy carried out by the EP (Group 1: therapy with morphine and oxygen; Group 2: therapy with morphine, bronchodilator effective drugs and oxygen; Group 3: therapy with bronchodilator effective drugs and oxygen; Group 4: therapy with oxygen; Group 5: no medical treatment). Moreover, EPs were interviewed about their actions and their uncertainties in the treatment of palliative care patients. The diagnosis of acute dyspnoea in palliative care patients occurred 121 times (116 patients were integrated in the present investigation) within the defined period. In total, 116 patients were included (Group 1: 21, Group 2: 29, Group 3: 31, Group 4: 28, and Group 5: 7). Dyspnoea was satisfactorily treated in 41 percent of the patients (Group 1: 67 percent, Group 2: 52 percent, Group 3: 22 percent, Group 4: 18 percent, and Group 5: 71 percent). Most EPs (70 percent) revealed uncertainties in emergency medical therapy for patients at the end of life. The current investigation showed a significant relief of acute dyspnoea when using opioids, in contrast with the established out-of-hospital emergency medical therapy for acute dyspnoea. Therefore, opioids should be recommended for emergency medical therapy of dyspnoea in palliative care patients. Clinical studies that recommend the use of effective opioids for the treatment of dyspnoea in palliative care patients are supported by the current retrospective study. Most EPs felt uncertain in the treatment of palliative care patients. Therefore, advanced training in palliative care medicine and end-of-life care should be integrated into emergency medical training.

Non-Small-Cell Lung Cancer (NSCLC) Harboring ALK Translocations: Clinical Characteristics and Management in a Real-Life Setting: a French Retrospective Analysis (GFPC 02-14 Study).

PubMed

Auliac, Jean-Bernard; Monnet, Isabelle; Dubos-Arvis, Catherine; Chiappa, Anne Marie; Baize, Nathalie; Bota, Suzana; Vergnenegre, Alain; Doubre, Helene; Locher, Chrystele; Bizieux, Acya; Robinet, Gilles; Chouaid, Christos

2017-12-01

Chromosomal translocations involving the anaplastic lymphoma kinase gene (ALK) are rare oncogenic events found in 3-5% of non-small-cell lung cancers (NSCLC). Limited data have been published on the management of these patients outside clinical trials. To investigate the clinical characteristics and management of patients with NSCLC harboring ALK translocations (ALK+) in a real-life setting in France. This multicenter, observational, retrospective study included all NSCLC patients harboring ALK translocations diagnosed in participating centers between January 2012 and December 2014. Patient data include clinical characteristics, disease management, and outcomes [progression-free survival (PFS) and overall survival (OS)]. The 31 participating centers reported data on 132 patients, of whom 51% (n = 67) were male. The median age was 60.1 ± 14.5 (standard deviation) years; 89% (n = 106/119) had performance status 0/1 at diagnosis; 79% (n = 103/130) were non- or former smokers; 93% (n = 120/129) had adenocarcinomas and 74%(n = 97)/19%(n = 25)/7%(n = 10) had disease stages IV/III/I-II at diagnosis, respectively; co-mutations included EGFR (n = 2), BRAF (n  = 2), KRAS (n = 1), and HER2 (n = 1). Of the patients with stage IV NSCLC (n = 97), 96% received first-line treatment [75% chemotherapy-based, 21% ALK tyrosine kinase inhibitor (TKI)], with an associated response rate (RR), disease-control rate (DCR), and PFS of 42%, 64%, and 7.5 [95% confidence interval (CI) 5.9-9.5] months, respectively; 62% received second-line treatment (28% chemotherapy, 72% ALK TKI) with an associated RR, DCR, and PFS of 43.4%, 70%, and 4.7 (95% CI 4.0-8.1) months, respectively. The 2-year OS was 56.7% (95% CI 45.5-70.4%); median OS was not reached. The results of this real-life analysis suggest that the prognosis of NSCLC patients with theALK translocation may be better than that of the overall NSCLC population, but the outcomes were poorer than those of ALK+ NSCLC patients included in clinical studies.

Lack of Early Improvement Predicts Poor Outcome Following Acute Intracerebral Hemorrhage.

PubMed

Yogendrakumar, Vignan; Smith, Eric E; Demchuk, Andrew M; Aviv, Richard I; Rodriguez-Luna, David; Molina, Carlos A; Silva Blas, Yolanda; Dzialowski, Imanuel; Kobayashi, Adam; Boulanger, Jean-Martin; Lum, Cheemun; Gubitz, Gord; Padma, Vasantha; Roy, Jayanta; Kase, Carlos S; Bhatia, Rohit; Ali, Myzoon; Lyden, Patrick; Hill, Michael D; Dowlatshahi, Dar

2018-04-01

There are limited data as to what degree of early neurologic change best relates to outcome in acute intracerebral hemorrhage. We aimed to derive and validate a threshold for early postintracerebral hemorrhage change that best predicts 90-day outcomes. Derivation: retrospective analysis of collated clinical stroke trial data (Virtual International Stroke Trials Archive). retrospective analysis of a prospective multicenter cohort study (Prediction of haematoma growth and outcome in patients with intracerebral haemorrhage using the CT-angiography spot sign [PREDICT]). Neurocritical and ICUs. Patients with acute intracerebral hemorrhage presenting less than 6 hours. Derivation: 552 patients; validation: 275 patients. None. We generated a receiver operating characteristic curve for the association between 24-hour National Institutes of Health Stroke Scale change and clinical outcome. The primary outcome was a modified Rankin Scale score of 4-6 at 90 days; secondary outcomes were other modified Rankin Scale score ranges (modified Rankin Scale, 2-6, 3-6, 5-6, 6). We employed Youden's J Index to select optimal cut points and calculated sensitivity, specificity, and predictive values. We determined independent predictors via multivariable logistic regression. The derived definitions were validated in the PREDICT cohort. Twenty-four-hour National Institutes of Health Stroke Scale change was strongly associated with 90-day outcome with an area under the receiver operating characteristic curve of 0.75. Youden's method showed an optimum cut point at -0.5, corresponding to National Institutes of Health Stroke Scale change of greater than or equal to 0 (a lack of clinical improvement), which was seen in 46%. Early neurologic change accurately predicted poor outcome when defined as greater than or equal to 0 (sensitivity, 65%; specificity, 73%; positive predictive value, 70%; adjusted odds ratio, 5.05 [CI, 3.25-7.85]) or greater than or equal to 4 (sensitivity, 19%; specificity, 98%; positive predictive value, 91%; adjusted odds ratio, 12.24 [CI, 4.08-36.66]). All definitions reproduced well in the validation cohort. Lack of clinical improvement at 24 hours robustly predicted poor outcome and showed good discrimination for individual patients who would do poorly. These findings are useful for prognostication and may also present as a potential early surrogate outcome for future intracerebral hemorrhage treatment trials.

Intravenous immunoglobulin in children with streptococcal toxic shock syndrome.

PubMed

Shah, Samir S; Hall, Matthew; Srivastava, Raj; Subramony, Anupama; Levin, James E

2009-11-01

Streptococcal toxic shock syndrome (TSS) is a rare and severe manifestation of group A streptococcal infection. The role of intravenous immunoglobulin (IVIG) for streptococcal TSS in children is controversial. This study aims to describe the epidemiology of streptococcal TSS in children and to determine whether adjunctive therapy with IVIG is associated with improved outcomes. A multicenter, retrospective cohort study of children with streptococcal TSS from 1 January 2003 through 31 December 2007 was conducted. Propensity scores were used to determine each child's likelihood of receiving IVIG. Differences in the primary outcomes of death, hospital length of stay, and total hospital costs were compared after matching IVIG recipients and nonrecipients on propensity score. The median patient age was 8.2 years. IVIG was administered to 84 (44%) of 192 patients. The overall mortality rate was 4.2% (95% confidence interval, 1.8%-8.0%). Differences in mortality between IVIG recipients (n = 3; 4.5%) and nonrecipients (n = 3; 4.5%) were not statistically significant (p > .99). Although patients receiving IVIG had higher total hospital and drug costs than nonrecipients, differences in hospital costs were not significant once drug costs were removed (median difference between matched patients, $6139; interquartile range, -$8316 to $25,993; P = .06). No differences were found in length of hospital stay between matched IVIG recipients and nonrecipients. This multicenter study is, to our knowledge, the largest to describe the epidemiology and outcomes of children with streptococcal TSS and the first to explore the association between IVIG use and clinical outcomes. IVIG use was associated with increased costs of caring for children with streptococcal TSS but was not associated with improved outcomes.

Efficacy of a ketogenic diet in resistant myoclono-astatic epilepsy: A French multicenter retrospective study.

PubMed

Stenger, Elodie; Schaeffer, Mickael; Cances, Claude; Motte, Jacques; Auvin, Stéphane; Ville, Dorothée; Maurey, Hélène; Nabbout, Rima; de Saint-Martin, Anne

2017-03-01

Recent studies have suggested that the early introduction of a ketogenic diet (KD) could improve seizure control in myoclono-astatic epilepsy (MAE). This multicenter study sought to identify the benefits of KD use on seizure control and epilepsy and on developmental outcomes in children with resistant MAE. Fifty children who were diagnosed with severe MAE in the French network of Reference Centers for Rare Epilepsies and who were treated with KD between 2000 and 2013 were included in this study. The seizure frequency and EEG recordings were assessed two weeks before KD introduction, 2 and 6 months after, and during the last follow-up, which also included an assessment of developmental outcome. Patients had a median follow up of 52 months (range 13-136) and received 4.3 antiepileptic drugs [2-9] before KD introduction. Fifty-four percent (54%) of our patients were seizure-free after 6 months of KD or more, and 86% experienced more than a 70% seizure reduction after 2 months of KD. Forty-four percent (44%) of them had a clear benefit of early KD treatment (after four AEDs failed). Early KD treatment did not result in a greater seizure reduction (p=0.055), but significantly resulted in remission (p<0.028). Fifty percent of patients with resistant MAE had normal development outcomes. Earlier KD treatment, after three AEDs failed, was correlated with a better cognitive outcome (p<0.01). Early introduction of KD treatment in resistant MAE has a strong, persistent anticonvulsant effect with long-term remission and better cognitive outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bagla, Sandeep, E-mail: sandeep.bagla@gmail.com; Sayed, Dawood; Smirniotopoulos, John

BackgroundRadiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM.MethodsFifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancermore » Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval.ResultsTwenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported.ConclusionRFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.« less

Utilization of Subcutaneous Methotrexate in Rheumatoid Arthritis Patients After Failure or Intolerance to Oral Methotrexate: A Multicenter Cohort Study.

PubMed

Branco, Jaime C; Barcelos, Anabela; de Araújo, Filipe Pombo; Sequeira, Graça; Cunha, Inês; Patto, José Vaz; Oliveira, Margarida; Mateus, Margarida Pratas; Couto, Maura; Nero, Patrícia; Pinto, Patrícia; Monteiro, Paulo; Castelão, Walter; Félix, Jorge; Ferreira, Diana; Almeida, João; Silva, Maria João

2016-01-01

Low-dose weekly methotrexate (MTX) is the mainstay in the therapy of rheumatoid arthritis (RA). It can be given via oral, intramuscular or subcutaneous (SC) route. This study sought to determine the real-world pattern of treatment with SC MTX in Portuguese adult patients with active RA. Utilization of Metoject(®) in Rheumatoid Arthritis (UMAR) was a non-interventional, cohort multicenter study with retrospective data collection. Eligible patients had active RA, at least 18 years of age, and started SC MTX treatment in 2009 or 2010 after failure or intolerance to oral MTX. Data were collected from patient's clinical records. Both non-parametric and parametric survival methods were used to obtain a detailed understanding of SC MTX treatment duration. Fifty patients were included, of which only 9 discontinued SC MTX during the study follow-up period. The probability of discontinuation after 1, 2, and 3 years of treatment of SC MTX treatment is expected to be 6.10%, 8.50%, and 23.20%, respectively. The extrapolated median duration of SC MTX using an exponential model was 106.4 months/8.87 years. Mean dose of SC MTX was 18.36 mg. The reasons for treatment discontinuation were occurrence of adverse events in six patients and lack of efficacy in three. The long treatment duration of SC MTX highlights its excellent tolerability compared to oral MTX, especially concerning the frequent adverse gastrointestinal events of MTX. Furthermore, long MTX treatment duration provides the opportunity to postpone or even avoid expensive therapies with biologics. The results obtained from the UMAR study provide important information for the utilization and public financing of SC MTX in Portugal.

Radiographic predictors for the development of myelopathy in patients with ossification of the posterior longitudinal ligament: a multicenter cohort study.

PubMed

Matsunaga, Shunji; Nakamura, Kozo; Seichi, Atsushi; Yokoyama, Toru; Toh, Satoshi; Ichimura, Shoichi; Satomi, Kazuhiko; Endo, Kenji; Yamamoto, Kengo; Kato, Yoshiharu; Ito, Tatsuo; Tokuhashi, Yasuaki; Uchida, Kenzo; Baba, Hisatoshi; Kawahara, Norio; Tomita, Katsuro; Matsuyama, Yukihiro; Ishiguro, Naoki; Iwasaki, Motoki; Yoshikawa, Hideki; Yonenobu, Kazuo; Kawakami, Mamoru; Yoshida, Munehito; Inoue, Shinsuke; Tani, Toshikazu; Kaneko, Kazuo; Taguchi, Toshihiko; Imakiire, Takanori; Komiya, Setsuro

2008-11-15

A multicenter cohort study was performed retrospectively. To identify radiographic predictors for the development of myelopathy in patients with ossification of the posterior longitudinal ligaments (OPLL). The pathomechanism of myelopathy in the OPLL remains unknown. Some patients with large OPLL have not exhibited myelopathy for a long periods of time. Predicting the course of future neurologic deterioration in asyptomatic patients with OPLL is difficult at their initial visit. A total of 156 OPLL patients from 16 spine institutes with an average of 10.3 years of follow-up were reviewed. Subjects underwent a plain roentgenogram, computed tomography (CT), and magnetic resonance imaging of the cervical spine during the follow-up. The trauma history of the cervical spine, maximum percentage of spinal canal stenosis in a plain roentgenogram and CT, range of motion of the cervical spine, and axial ossified pattern in magnetic resonance imaging or CT were reviewed in relation to the existence of myelopathy. All 39 patients with greater than 60% spinal canal stenosis on the plain roentgenogram exhibited myelopathy. Of 117 patients with less than 60% spinal canal stenosis, 57 (49%) patients exhibited myelopathy. The range of motion of the cervical spine was significantly larger in patients with myelopathy than in those of without it. The axial ossified pattern could be classified into 2 types: a central type and a lateral deviated type. The incidence of myelopathy in patients with less than 60% spinal canal stenosis was significantly higher in the lateral deviated-type group than in the central-type group. Fifteen patients of 156 subjects developed trauma-induced myelopathy. Of the 15 patients, 13 had mixed-type OPLL and 2 had segmental-type OPLL. Static and dynamic factors were related to the development of myelopathy in OPLL.

Time trends in antithrombotic management of patients with atrial fibrillation treated with coronary stents: Results from TALENT-AF (The internAtionaL stENT - Atrial Fibrillation study) multicenter registry.

PubMed

Potter, Brian J; Andò, Giuseppe; Cimmino, Giovanni; Ladeiras-Lopes, Ricardo; Frikah, Zied; Chen, Xin Yue; Virga, Vittorio; Goncalves-Almeida, Joao; Camm, A John; Fox, Keith A A

2018-04-01

Antithrombotic management of patients with atrial fibrillation (AF) requiring percutaneous coronary intervention (PCI) is highly variable; limited evidence-based guidelines exist to influence practice. Patient characteristics and availability of novel drugs may have contributed to practice variability. We undertook an international multicenter retrospective registry of AF patients treated with PCI. The primary measures of interest were antiplatelet and OAC prescriptions at discharge. We compared temporal trends between Prior (2010-2012) and Recent (2013-2015) cohorts and investigated variables associated with OAC prescription. We identified 488 cases (140 Prior, 348 Recent). Median CHADS 2 and HAS-BLED scores were 2 (IQR, 1-3) and 2 (IQR, 2-3). Clinical characteristics were similar between cohorts, with high (85%) prevalence of ACS. More patients in the Recent cohort, compared with Prior, received OAC (56.9% vs 44.3%; P = 0.01) and NOAC (27.3% vs 3.6%; P < 0.01) at baseline. Triple therapy at discharge was not different between the cohorts. Clinical presentation with ACS and consequent use of potent P2Y 12 inhibitors were associated with reduced odds of OAC prescription at discharge (OR: 0.57, P = 0.045 and OR: 0.38, P = 0.023, respectively). Despite little change over time in clinical characteristics of AF patients undergoing PCI, significantly more patients received OAC at presentation. However, triple therapy was not more frequent in the Recent cohort, and ACS presentation was associated with lack of OAC at discharge. We underscore the need for trial evidence and use of updated guidelines to assist clinicians in balancing ischemic and bleeding risks. © 2018 Wiley Periodicals, Inc.

Intravenous Immune Globulin in Children with Streptococcal Toxic Shock Syndrome

PubMed Central

Shah, Samir S.; Hall, Matthew; Srivastava, Raj; Subramony, Anupama; Levin, James E.

2009-01-01

Background Streptococcal toxic shock syndrome (TSS) is a rare and severe manifestation of group A streptococcal infection. The role of intravenous immune globulin (IVIG) for streptococcal TSS in children is controversial. Objective To describe the epidemiology of streptococcal TSS in children and to determine whether adjunctive therapy with IVIG is associated with improved outcomes. Methods A multicenter retrospective cohort study of children with streptococcal TSS from 2003-2007 was conducted. Propensity scores were used to determine each child's likelihood of receiving IVIG. Differences in the primary outcomes of death, hospital length of stay, and total hospital costs were compared after matching IVIG-recipients and non-recipients on propensity score. Results The median age was 8.2 years. IVIG was administered to 84 (44%) of 192. Overall mortality was 4.2% (95% confidence interval: 1.8% to 8.0%). Differences in mortality between IVIG recipients (n=3, 4.5%) and non-recipients (n=3, 4.5%) were not statistically significant (P=1.00). While patients receiving IVIG had higher total hospital and drug costs than non-recipients, differences in hospital costs were not significant once drug costs were removed (median difference between matched patients, $6,139; interquartile range: -$8,316 to $25,993; P=0.06). There were no differences in length of stay between matched IVIG recipients and non-recipients. Conclusion This multicenter study is the largest to describe the epidemiology and outcomes of children with streptococcal TSS and the first to explore the association between IVIG use and clinical outcomes. IVIG use was associated with increased costs of caring for children with streptococcal TSS but was not associated with improved outcomes. PMID:19788359

Clinical features and long-term progression of reticular pseudodrusen in age-related macular degeneration: findings from a multicenter cohort.

PubMed

Gil, J Q; Marques, J P; Hogg, R; Rosina, C; Cachulo, M L; Santos, A; Staurenghi, G; Chakravarthy, U; Silva, R

2017-03-01

PurposeTo determine whether reticular pseudodrusen (RPD) confer a long-term increased risk of progression to late age-related macular degeneration (AMD) in the fellow eye of patients with unilateral wet-AMD.Patients and methodsThis was a multicenter, combined prospective and retrospective, longitudinal, observational, study. Patients with wet-AMD in one eye were recruited from two centers and evaluated on the risk of progression to late-AMD in the second eye (study eye). A minimum follow-up of 5 years was required, unless progression occurred first. Baseline retinal profile of patients was evaluated using multimodal imaging. Baseline images were graded by two separate centers.ResultsWe recruited 88 patients (48 female) with a mean age of 75.6±7.1 years and mean follow-up of 65.7±20.9 months. Baseline prevalence of RPD was 58% (n=51). There was no statistically significant association of RPD with increased age (P=0.29) or sex distribution (P=0.39). The most sensitive image modality for RPD was IR (93%), followed by FAF (92%), OCT (74%, RF (33%) and CFP (29%). After 5 years, 54.50% (n=48) of the study eyes progressed to late-AMD. Of those, 81.25% (n=39) developed CNV and 18.75% (n=9) geographic atrophy. After correcting for age and sex, the presence of RPD was significantly associated with development of late-stage AMD (OR=2.55, P=0.03).ConclusionA multimodal approach is mandatory for RPD detection. RPD are highly prevalent in the fellow eyes of patients with unilateral neovascular AMD. Presence of RPD is associated with increased long-term risk of progression, highlighting the importance of comprehensive multimodal retinal imaging and careful monitoring of at-risk patients.

Prognostic Role of Multiple Lymphatic Basin Drainage in Sentinel Lymph Node-Negative Trunk Melanoma Patients: A Multicenter Study from the Italian Melanoma Intergroup.

PubMed

Ribero, Simone; Osella-Abate, Simona; Pasquali, Sandro; Rossi, Carlo Riccardo; Borgognoni, Lorenzo; Piazzalunga, Dario; Solari, Nicola; Schiavon, Mauro; Brandani, Paola; Ansaloni, Luca; Ponte, Erica; Silan, Francesco; Sommariva, Antonio; Bellucci, Francesco; Macripò, Giuseppe; Quaglino, Pietro

2016-05-01

Multiple lymphatic basin drainage (MLBD) is frequently observed in patients with trunk melanoma undergoing sentinel lymph node (SLN) biopsy. Conflicting data regarding the prognostic association of MLBD in SLN-negative patients have been reported. This study aimed to investigate the prognostic role of MLBD in patients with negative SLN biopsy. Retrospective data from 656 melanoma patients who underwent a SLN biopsy (1991-2012) at six Italian centers were gathered in a multicenter database. MLBD was defined as lymphoscintigraphic and intraoperative identification of an SLN in more than one nodal basin. Clinical and pathologic variables were recorded and analyzed for their impact on survival. SLN-negative patients with MLBD were at lower risk of melanoma recurrence [hazard ratio (HR) 0.73, P = 0.05) and melanoma-related death (HR 0.68, P = 0.001) independent of common staging features. Multivariable Cox analyses of disease-free interval (DFI) and disease-specific survival (DSS) showed that MLBD maintained a favorable role and ulceration an unfavorable role. Histologic regression was independently associated only with DFI. When survival was stratified according to presence of MLBD, histologic regression and Breslow thickness <2 mm were associated with improved DFI (5-year DFI: 96.9 vs. 66,1 %, respectively; HR 0.48, P < 0.001) and DSS (5-year DSS: 96.7 vs. 71.8 %, respectively; HR 0.52, P = 0.005) compared to patients without these three favorable parameters. Patients with negative SLN biopsy results have better prognosis when two or more lymphatic basins are identified and analyzed. Further research is required to investigate the mechanisms behind this evidence.