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PubMed2003

Multicenter study of pegylated liposomal doxorubicin in patients with cutaneous T-cell lymphoma.

BACKGROUND: In single center studies and case reports, it was shown that pegylated liposomal doxorubicin (PEG-DOXO) was effective as second-line therapy for patients with cutaneous T-cell lymphoma (CTCL). The objective of this study was to evaluate the efficacy and toxicity of single-agent PEG-DOXO as second-line chemotherapy in patients with CTCL. METHODS: A retrospective, multicenter study was performed evaluating 34 patients (31 male patients and 3 female patients). Twenty-seven patients received PEG-DOXO 20 mg/m(2), 5 patients received PEG-DOXO 20-30 mg/m(2), and 2 patients received PEG-DOXO 40 mg/m(2). PEG-DOXO was administered intravenously every 2 weeks in 6 patients, every 2-3 weeks in 4 patients, and every 4 weeks in 23 patients. One patient received only a single course of PEG-DOXO. Outcomes were evaluated, and adverse effects were recorded. RESULTS: Thirty-four patients received at least 1 cycle of PEG-DOXO. Disease was classified as mycosis fungoides in 28 patients, mycosis fungoides with follicular mucinosis in 2 patients, small or medium-sized pleomorphic CTCL in 2 patients, Sèzary syndrome in 1 patient, and CD30 positive CTCL in 1 patient. Fifteen patients achieved a complete response (CR), including patients who achieved a CR and patients who achieved a CR defined by clinical criteria only with no biopsy (CRu), and 15 patients achieved a partial response (PR), resulting in a response rate (CRs, CRus, and PRs) of 88.2%. Two patients dropped out: one patient after a single PEG-DOXO infusion because of Grade 3 capillary leakage syndrome and one patient after two cycles because of a suicide attempt that was not related to treatment or to CTCL. All other patients received at least four cycles of PEG-DOXO. Overall survival was 17.8 months +/- 10.5 months (n = 33 patients), event-free survival was 12.0 months +/- 9.5 months, and disease-free survival was 13.3 +/- 10.5 months (n = 16 patients). Adverse effects were seen in 14 of 34 patients (41.2%); they were temporary and generally mild. Only 6 patients had Grade 3 or 4 adverse effects. CONCLUSIONS: This multicenter study provided evidence of high efficacy of PEG-DOXO monotherapy with a low rate of severe adverse effects compared with other chemotherapy protocols in patients with CTCL.

Adult↗
PubMed1996

A multicenter comparison of dual-energy X-ray absorptiometers: in vivo and in vitro measurements of bone mineral content and density.

As part of a multicenter research project, we compared dual-energy X-ray absorptiometry (DXA) instruments at three research centers (sites 1, 2 and 3) to determine both intra- and intersite variability of bone mineral content (BMC), bone mineral density (BMD), and bone area (BA). Scans of the total body and lumbar spine were performed in duplicate on five humans (in vivo), and scans of the total body were performed on two whole body phantoms with artificial skeletons and thickness overlays (in vitro) at all sites over 15 days. The average intrasite variability in two consecutive total body BMD measurements, expressed as a percent difference, was significantly higher in vitro, 1.74 +/- 1.97%, than in vivo, 0.71 +/- 0.38% (p < 0.05). Average intrasite variability of the in vivo lumbar spine BMD was 1.08 +/- 1.12%. The intersite coefficients of variation for all BMD, BMC, and BA measurements were < 2.0%. The total body BMD from site 2 was systematically lower than at sites 1 and 3 both in vivo and in vitro (p < 0.05) with no differences in BMC and BA. Although significant, the total body BMD differences between sites were small (< 1.2%) in vivo compared with in vitro (< 2.6%) and are encouraging for the comparison and pooling of human data from multicenter trials, provided that appropriate standardized cross-calibration and analysis procedures are applied.

Absorptiometry, Photon↗
PubMedDate not supplied

Multicenter epidemiologic and health services research on therapeutics in the HMO Research Network Center for Education and Research on Therapeutics.

Research and education programs in therapeutics that combine the data, organizational capabilities, and expertise of several managed care organizations working in concert can serve an important role when a single organization is not large enough to address a question of interest, when diversity in populations or delivery systems is required, and when it is necessary to establish consistency of results in different settings. Nine members of the HMO Research Network, a consortium of health maintenance organizations (HMOs) that perform public domain research, have formed a Center for Education and Research on Therapeutics (CERT), sponsored by the Agency for Healthcare Research and Quality, to conduct multicenter research in therapeutics. The CERT uses a distributed organizational model with shared leadership, in which data reside at the originating organization until they are needed to support a specific study. Extraction of data from the host computer systems, and some manipulation of data, is typically accomplished through computer programs that are developed centrally, then modified for use at each site. For complex studies, pooled analysis files are created by a coordinating center, and then analysed by investigators throughout the HMOs. It is also possible to contact HMO members when necessary. This multicenter environment has several benefits, addressing: (1) a wide array of questions about the safety and effectiveness of therapeutics, (2) the impact of efforts to change clinicians' and patients' behavior, and (3) pharmacoeconomic and pharmacogenetic questions.

Community Networks↗
PubMed2002

Use of nasal potential difference and sweat chloride as outcome measures in multicenter clinical trials in subjects with cystic fibrosis.

One of the goals of current research in cystic fibrosis (CF) is to develop treatments that correct or compensate for defects in function of the cystic fibrosis transmembrane regulator (CFTR) gene. The use of outcome measures that assess CFTR function such as nasal potential difference (NPD) measurements and sweat chloride determinations will be required to evaluate the efficacy of such treatments in multicenter clinical trials. The purpose of this work was to identify the sources and magnitude of variability in NPD and sweat chloride measurements when performed at multiple centers. For the variance component analysis presented here, we used NPD and sweat chloride measurements from 37 subjects with CF participating in a phase I, four-center clinical trial of CPX (8-cyclopentyl-1,3-dipropylxanthine), a drug intended to enhance trafficking of Delta F508 CFTR to the cell membrane. The specific techniques used to measure these outcomes were not standardized, and varied between the four sites. Variability of both NPD measurements (baseline potential difference during infusion with Ringer's solution; change in response to addition of 0.1 mM amiloride; and subsequent change in response to perfusion with low chloride solution containing 0.1 mM amiloride and 0.01 mM isoproterenol) and sweat chloride measurements differed significantly between study sites. For change in NPD, one study site had significantly greater variability (lower reproducibility) of measurement than the other three sites. For sweat chloride measurements, reproducibility was lower at two of the sites relative to the other two sites. Sample size calculations showed that lower reproducibility at one or more sites can substantially reduce the power of studies using NPD or sweat chloride determinations as outcome measures. Standardization of measurement protocols, careful operator training and certification, and ongoing monitoring of individual operator performance may help to improve reliability in multicenter trials.

Adolescent↗
PubMed1999

A multicenter, randomized, double-blind, placebo-controlled trial of high-dose intravenous immunoglobulin for oral corticosteroid-dependent asthma.

To determine the efficacy of high doses of intravenous gammaglobulin (IVIG) for the treatment of severe, steroid-dependent asthma in patients between 6 and 68 years of age, a randomized, double-blind, placebo-controlled multicenter clinical trial was conducted in private and university hospitals in the United States. Patients were randomized to one of three treatment arms: 2 g IVIG/kg/month (16 patients); 1 g IVIG/kg/month (9 patients); or 2 g iv albumin (placebo)/kg/month (15 patients). The treatment consisted of seven monthly infusions followed by a posttreatment observation period. The primary outcome measurement was mean daily prednisone-equivalent dose requirements, determined during the observation month preceding initiation of treatment and compared to the month preceding the seventh infusion. Secondary clinical endpoints measured were pulmonary function, frequency of emergency room visits or hospitalizations, and number of days absent from school or work. When adjusted for body weight, the mean dose requirements fell by 33, 39, and 33% in the placebo, IVIG (1 g/kg), and IVIG (2 g/kg) treatment arms, respectively. The differences between therapies were not statistically different (P = 0.9728). The mean percentage-of-predicted FEV1 fell in all three treatment groups during the treatment period but there was no significant difference between treatment groups (P = 0.8291). There was also no significant difference in the percentage of subjects requiring emergency room visits or hospitalizations or missing days of work/school, among the three treatment groups. The trial was terminated prematurely after interim analysis determined the adverse experience rate was different between the three groups. Three patients, all randomized to the 2-g/kg IVIG dose group, were hospitalized with symptoms consistent with aseptic meningitis. In summary, in this randomized, double-blind, placebo-controlled multicenter study, high doses of IVIG did not demonstrate a clinically or statistically significant advantage over placebo (albumin) infusions for the treatment of corticosteroid-dependent asthma. Subgroup analysis failed to identify markers predicting responsiveness. High-dose IVIG can also be associated with a significant incidence of serious adverse events.

Administration, Oral↗
PubMedDate not supplied

Operational design and quality control in the CATCH multicenter Trial.

BACKGROUND: The Child and Adolescent Trial for Cardiovascular Health (CATCH) was the first multicenter school-based research study to employ the fundamentals of clinical trials including the standardized protocol and Manuals of Operation, a steering committee for study governance, a distributed data system, an extensive quality control system, and a Data and Safety Monitoring Board. METHOD: CATCH tested the effectiveness of changes in school lunches, physical education, smoking policy, curricula, and family activities. Ninety-six elementary schools in four states were randomized to intervention or control conditions. The baseline cohort comprised 5, 106 ethnically diverse third graders followed through fifth grade. RESULTS: The percentages of calories from fat and saturated fat were reduced significantly more in the intervention school lunches than among the controls. Significant increases in moderate to vigorous activity levels in existing physical education classes were made as well. Changes in self-reported dietary, physical activity, and psychosocial measures were significant. There were no significant differences in the physiological measures. Measurement error was generally low for all physiologic measures except skinfolds, indicating a high level of reliability. Across all sites, the coefficients of variation for lipids, height, and weight were less than 3%, whereas for skinfolds, they were considerably higher, ranging from 6 to 8%. Intraclass correlations for lipid studies were also uniformly high at 0.99. Interobserver agreement scores for SOFIT were greater than 90% for 9 of the 11 activities observed. Data entry error rates were low with less than five errors per 1,000 fields for all forms. CONCLUSIONS: The CATCH results provided more scientific evidence on the importance of schools in the population approach to health promotion. Many of the strategies used in this complex multicenter trial in the areas of design and analysis, measurement, training, data management, and quality control protocols might be appropriate for adoption in other studies.

Adolescent↗
PubMed1995

New directions in dietary studies and heart disease: the National Heart, Lung and Blood Institute sponsored Multicenter Study of Diet Effects on Lipoproteins and Thrombogenic Activity.

The National Heart, Blood and Lung Institute-sponsored DELTA study is the first collaborative, multicenter diet study to utilize standardized protocols to feed specific diets to study participants. In the first study, the investigators are focusing on the effects of reducing dietary saturated fat on plasma lipids, lipoproteins, and thrombogenic activity. Future studies will attempt to address important diet/public health questions dealing with high carbohydrate vs. high monounsaturated fat diets, and the cholesterol raising activity of specific saturated fatty acids. Moreover, DELTA will be an invaluable model for other multicenter diet studies.

Adult↗
PubMed1994

Ultrasound measurements on the os calcis in a prospective multicenter study.

Ultrasonic assessment is a new approach to assess both quality and density. Two ultrasonic parameters are measured on the os calcis: the attenuation or broadband ultrasound attenuation (BUA) and the velocity or speed of sound (SOS). The interunit variations in vitro and in vivo of an ultrasound instrument, the Lunar Achilles system, used in a French multicenter study named EPIDOS, were calculated and the stability of these instruments over a 12-month period was evaluated. A third parameter called "stiffness index," calculated from the SOS and BUA, was also used in this study. The average CV in vitro for the BUA and SOS was 0.92% and 0.12%, respectively, and the average CV in vivo for the BUA, the SOS, and the stiffness index was 1.83%, 0.23%, and 1.9%, respectively. The interunit (or inter-machines) variations were calculated by a one-way analysis of variance. We detected small but significant measurement differences among centers on a phantom for both SOS (maximum significant difference 0.4%) and stiffness (maximum significant difference 3.5%) but not for BUA. Similar differences were found in vivo. The precision over 12 months of the interunit variations in vitro was evaluated by measuring a single phantom traveling from one center to another several times. The range of the CV for the BUA (1.54-0.51%), for the SOS (0.25-0.14%), and for the stiffness index (2.26-1.10%) are explained in part by technical failures. The variation among the five Achilles was estimated by the combined CV which was 1.42% for the BUA, 0.32% for the SOS, and 2.33% for the stiffness index. In conclusion, our findings indicate that equipment from one manufacturer appears to be consistent between machines for the BUA, but not completely for the SOS. The results for this stiffness index are necessarily influenced by both SOS and BUA. The short-term and long-term interunit precision is good, both in vitro and in vivo. Such results provide increased confidence in multicenter clinical trials where ultrasonic data are pooled.

Adult↗
PubMed1995

Quality control of DXA instruments in multicenter trials.

Dual-energy X-ray absorptiometry (DXA) has become the measurement of choice for multicenter trials with bone density endpoints. When performing DXA measurements with several different systems, it is important to implement a quality assurance program to guarantee that any observed density changes are real and not due to machine and/or operator variability. In this study, we present a series of procedures based on phantom measurements designed to monitor DXA instrument stability. Techniques for longitudinal evaluation of machine performance and cross-calibration of instruments are described. These procedures are then demonstrated using quality assurance data collected from a number of different DXA scanners. Together these methods provide a defined approach to instrument quality control. Though based primarily on the use of spinal phantoms, these procedures can be generalized for use in any multicenter DXA study.

Absorptiometry, Photon↗
PubMed1994

In vitro antimicrobial activity of cefpirome against ceftazidime-resistant isolates from two multicenter studies.

The in vitro activity of cefpirome against ceftazidime-resistant (MIC > 16 mg/l) isolates from two multicenter studies was analyzed. The first investigation carried out in the USA, was an in vitro comparison of cefpirome and five third-generation cephalosporins in which more than 6,000 isolates were evaluated, including 97 Enterobacteriaceae and 1,509 staphylococci resistant to ceftazidime. The second study was a multicenter international study (> 5,000 strains total) in which 160 ceftazidime-resistant gram-negative bacilli and 509 staphylococci from five countries (Australia, France, Germany, Italy and UK) were tested against cefpirome. The results from the US trial indicated that only 0.8% of enteric bacilli were resistant to cefpirome compared to 4.9% and 4.7% resistant to ceftazidime and cefoperazone, respectively. In the international trial, cefpirome was also active against ceftazidime-resistant, class I beta-lactamase producing enteric bacilli (75% susceptibility, MIC50 of 4 mg/l) especially against Citrobacter spp., Enterobacter spp. and Morganella morganii. Cefpirome was 8- to 64-fold more active than ceftazidime against seven different staphylococcal species. The antimicrobial activity of cefpirome against routine clinical isolates and those organisms resistant to third-generation cephalosporins was highly consistent within a nation (USA) and among various developed countries.

Bacterial Infections↗
PubMed1999

[Incidence of immunogenic hyperthyroidism after radioiodine therapy of focal thyroid gland autonomy. Results of a multicenter study].

BACKGROUND: There are case reports in the literature that patients occasionally develop immunogenic hyperthyroidism 2 to 14 months following iodine-131-therapy of focal, non-immunogenic, autonomous thyroid nodules with a prevalence between 0.05 and 2.5%. Purpose of this multicenter evaluation was to assess the appearance of this phenomenon in a larger patient population. PATIENTS AND METHODS: So far 2867 patients out of 4 university hospitals are included in our study focusing on the appearance of pathologically elevated levels of thyrotropin-receptor-antibodies (TRAb) combined with hyperthyroidism following iodine-therapy. Records of the patients were screened for pre- and post-therapeutic biochemical tests, scintigraphic uptake patterns and ultrasound findings of the thyroid. RESULTS: Nineteen of 2867 patients with pretherapeutically scintigraphic "hot nodules" developed recurrent hyperthyroidism suggestive for immunogenic genesis 2 to 12 months following iodine-131-therapy (elevated TRAb-levels, homogeneous uptake in Tc-99m-pertechnetate scans). Pretherapeutically, 9 of these patients presented with a strictly focal scintigraphic uptake-pattern, 10 cases with a mixed disseminated-focal pattern. Because of missing pretherapeutic TRAb-tests in 8/9 patients presenting with a strictly focal scintigraphic uptake pattern, postradiogenic immunogenic hyperthyroidism could be reliably assessed in 1 case only. CONCLUSION: One could speculate that iodine-131-therapy may stimulate immunogenic mechanisms finally leading to immunogenic hyperthyroidism. Posttherapeutically observed hyperthyroidism following iodine-treatment might be based on an exacerbation of a preexisting--clinically not relevant/detectable--immunothyropathia. Also pretherapeutic TRAb-negative immunogenic hyperthyroidism could not be definitely excluded. Our multicenter data collected in a large patient population show similar results to the case reports of immunogenic hyperthyroidism following iodine-131-treatment in smaller populations. Therfore, the occurrence of this phenomenon plays a minor role regarding to its prevalence. Therapeutical consequences in treatment of functional thyroid autonomy are not recommended.

Adult↗
PubMed2000

An original accelerated radiotherapy schedule in stage III to IV head and neck cancers. Results in a multicenter setting.

BACKGROUND: Accelerated radiotherapy delivery has recently been shown to be effective in overcoming repopulation during fractionated radiotherapy. The therapeutic ratio may be particularly favorable for 5-week regimens. This study reports the feasibility and results of a particular accelerated schedule in Stage III to IV head and neck carcinomas used in a multicenter setting. PATIENTS AND METHODS: Seventy-four patients with Stage III (26 patients) or IV (48 patients) head and neck carcinomas were treated with a 5-week accelerated schedule (69.6 to 69.8 Gy in 41 to 40 fractions over a period of 35 to 36 days). Treatment began with 20 Gy in 10 daily fractions to initial involved sites, followed by bi-fractionated radiotherapy (2 x 1.6 Gy to 1.66 Gy/day) to a larger head and neck volume. Thirty-six (49%) patients received induction chemotherapy (median 3 cycles, range 1 to 4 cycles). RESULTS: Grade 3 or 4 (RTOG) confluent mucositis was observed in 57 patients (77%) and Grade 3 dysphagia in 33 patients (44%). Grade 3 or 4 (RTOG-EORTC) late complications were scored in 10.5% of cases. The 5-year actuarial locoregional control rate was 56% (95% CI: 42 to 71). The 5-year overall actuarial survival was 32% (95% CI: 18 to 46). Induction chemotherapy was not associated with a more favorable outcome. CONCLUSIONS: This study demonstrates the feasibility of this schedule in a multicenter setting. The oncologic results appear similar to those obtained by other accelerated regimens, while the rate of late complications seems acceptable. Five-week accelerated regimens warrant further evaluation, particularly in conjunction with concomitant chemotherapy, in the framework of prospective trials.

Actuarial Analysis↗
PubMed1998

[Review of the results of the ARO multicenter study].

The ARO multicenter study intended to show clinical and radiological differences with regard to different systems of fixation and designs of the prothesis in total hip replacement in patients with hip dysplasia, osteoarthritis and rheumatoid arthritis. In 1987 and 1988 5255 total hip prothesis were implanted by the 24 hospitals which took part in the study. 3133 prothesis (95.6%) were clinically and radiologically examined. The follow-up period averaged 6.9 years. The results of the Aro multicenter-study showed that despite difficult preoperative conditions especially in cases of rheumatoid arthritis the satisfaction rate improved remarkably. During the operation less complications arose in comparison to patients with hip dysplasia and osteoarthritis. Regarding the rate of infection after operation there were no differences between the 3 groups. Only the rate of post-operative luxation concerning rheumatoid patients turned out to be twice the number of the others. In our opinion this is due to the fact that these rheumatics were operated by posterior approach. Patients with rheumatoid arthritis were satisfied most with their surgeries. Results of rheumatic patients according to Harris hip score were slightly worse than the results of the two other groups. This was due to systemic involvement and bad preoperative function of the hip. As a result of the study there were no differences in using cemented or cementless techniques for rheumatic hip replacement. The decision for the method of fixation should depend on the patient's ability to relief the prothesis after operation. The study has shown that cementless implantation can also be used for young rheumatics provided that a suitable design of prothesis will be selected.

Arthritis, Rheumatoid↗
PubMed2001

Superior short-term results with eccentric calf muscle training compared to concentric training in a randomized prospective multicenter study on patients with chronic Achilles tendinosis.

In a previous uncontrolled pilot study we demonstrated very good clinical results with eccentric calf muscle training on patients with painful chronic Achilles tendinosis located at the 2-6 cm level in the tendon. In the present prospective multicenter study (Sundsvall and Umeå) patients with painful chronic Achilles tendinosis at the 2-6 cm level in the tendon were randomized to treatment with either an eccentric or a concentric training regimen for the calf muscles. The study included 44 patients, with 22 patients (12 men, 10 women; mean age 48 years) in each treatment group. The amount of pain during activity (jogging or walking) was recorded by the patients on a visual analogue scale, and patient satisfaction was assessed before and after treatment. The patients were instructed to perform their eccentric or concentric training regimen on a daily basis for 12 weeks. In both types of treatment regimen the patients were told to do their exercises despite experiencing pain or discomfort in the tendon during exercise. The results showed that after the eccentric training regimen 82% of the patients (18/22) were satisfied and had resumed their previous activity level (before injury), compared to 36% of the patients (8/22) who were treated with the concentric training regimen. The results after treatment with eccentric training was significantly better (P<0.002) than after concentric training. The good clinical results previously demonstrated in the pilot study with eccentric calf muscle training on patients with chronic Achilles tendinosis, were thus reproduced in this multicenter, showing superior results to treatment with concentric training.

Achilles Tendon↗
PubMedDate not supplied

The Pediatric Heart Network: a primer for the conduct of multicenter studies in children with congenital and acquired heart disease.

Most contemporary diagnostic and treatment strategies for pediatric patients with cardiovascular disease are not supported by evidence from clinical trials but instead are based on expert opinion, single-institution observational studies, or extrapolated from adult cardiovascular medicine. In response to this concern, the National Heart, Lung, and Blood Institute established the Pediatric Heart Disease Clinical Research Network (PHN) in 2001. The purposes of this article are to describe the initiation, structure, and function of the PHN; to review the ongoing studies; and to address current and future challenges. To date, four randomized clinical trials and two observational studies have been launched. Design and conduct of complex, multicenter studies in children with congenital and acquired heart disease must address numerous challenges, including identification of an appropriate clinically relevant primary endpoint, lack of preliminary data on which to base sample size calculations, and recruitment of an adequate number of subjects. The infrastructure is now well developed and capable of implementing complex, multicenter protocols efficiently and recruiting subjects effectively. The PHN is uniquely positioned to contribute to providing evidence-based medicine for and improving the outcomes of pediatric patients with cardiovascular disease.

Child↗
PubMed1997

Chest radiographic data acquisition and quality assurance in multicenter studies.

BACKGROUND: Multicenter studies rely on data derived from different institutions. Forms can be designed to standardize the reporting process allowing reliable comparison of data. OBJECTIVE: The purpose of the report is to provide a standardized method, developed as a part of a multicenter study of vertically transmitted HIV, for assessing chest radiographic results. MATERIALS AND METHODS: Eight hundred and five infants and children were studied at five centers; 3057 chest radiographs were scored. Data were entered using a forced-choice, graded response for 12 findings. Quality assurance measures and inter-rater agreement statistics are reported. RESULTS: The form used for reporting chest radiographic results is presented. Inter-rater agreement was moderate to high for most findings, with the best correlation reported for the presence of bronchovascular markings and/or reticular densities addressed as a composite question (kappa = 0.71). The presence of nodular densities (kappa = 0.56) and parenchymal consolidation (kappa = 0.57) had moderate agreement. Agreement for lung volume was low. CONCLUSION: The current tool, developed for use in the pediatric population, is applicable to any study involving the assessment of pediatric chest radiographs for a large population, whether at one or many centers.

Child↗
PubMed1999

The prevalence of sacroilitis in psoriatic arthritis: new perspectives from a large, multicenter cohort. A Department of Veterans Affairs Cooperative Study.

OBJECTIVE: To determine the prevalence of radiographic evidence of sacroiliitis in a large population of patients with psoriatic arthritis. PATIENTS AND DESIGN: Patients were recruited from 15 clinical centers. This was part of a large, multicenter study of patients with an established diagnosis of ankylosing spondylitis, psoriatic arthritis, or reactive arthritis. For this cohort, an established diagnosis of psoriatic arthritis was required, with cutaneous manifestations and involvement of at least three appendicular joints. At entry, patients were not selected for the presence of axial involvement. Radiographs - one anteroposterior view of the pelvis and one oblique view of each sacroiliac joint - were graded using the New York classification scale by a musculoskeletal radiologist masked to the specific diagnosis and clinical symptoms. Re-evaluation of 10% of the films 3 years later quantified intraobserver variability. RESULTS: Two hundred and two patients with psoriatic arthritis were studied. Duration of the disease averaged 12 years; all patients had psoriasis and peripheral arthritis. The prevalence of radiographic evidence of sacroiliitis (grade 2 or higher) was 78%; 71% of these had grade 3 disease. CONCLUSIONS: Previously reported prevalence of sacroiliitis in patients with psoriatic arthritis ranges from 30% to 50%. The prevalence of radiographic evidence of sacroiliitis in this large multicenter cohort of patients with appendicular psoriatic arthritis was substantially higher.

Arthritis, Psoriatic↗
PubMed2006

Hemoglobin-based oxygen carriers in trauma care: scientific rationale for the US multicenter prehosptial trial.

BACKGROUND: The greatest need for blood substitutes worldwide is in patients with unanticipated acute blood loss, and trauma is the most likely scenario. The blood substitutes reaching advanced clinical trials today are red blood cell (RBC) substitutes derived from hemoglobin. The hemoglobin-based oxygen carriers (HBOCs) tested currently in advanced clinical trials are polymerized hemoglobin solutions. METHODS: In the USA, the standard approach to restoring oxygen delivery for hemorrhagic shock has been crystalloid administration to expand intravascular volume, followed by stored RBCs for critical anemia. Allogeneic RBCs, however, may have adverse immunoinflammatory effects that increase the risk of postinjury multiple organ failure (MOF). Phase II in hospital clinical trials, as well as in vitro and in vivo work, suggest that resuscitation with an HBOC--in lieu of stored RBCs--attenuates the systemic inflammatory response invoked in the pathogenesis of MOF. Specifically, an HBOC has been shown to obviate stored RBC-provoked polymorphonuclear neutrophil (PMN) priming, endothelial activation, and systemic release of interleukins (IL) 6, 8, and 10. In a 2-event rodent study of shock-induced PMN-mediated acute respiratory distress syndrome (ARDS), the simulated prehospital administration of an HBOC markedly attenuated lung injury. RESULTS: Based on this background and work by others, we have initiated a US multicenter prehospital trial in which severely injured patients with major blood loss [systolic blood pressure (SBP) 500 injured patients have been enrolled in this multicenter trial, and the final interim analyses support the original target of 720.

Blood Substitutes↗