We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention.
Two simulations of draft Phase II and Phase III ...anifrolumab studies for systemic lupus erythematosus (SLE)/lupus nephritis (LN) were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA. The clinical trial simulation included an informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. Patients and staff were interviewed to obtain sentiments and perceptions related to the simulated visits.
The Atlanta study involved 6 African-American patients (5 female) aged 27-60 years with moderate to severe SLE/LN. The Altoona study involved 12 white females aged 32-75 years with mild to moderate SLE/LN. Patient experiences had an impact on four patient-centric care domains: 1) information, communication, and education; 2) responsiveness to needs; 3) access to care; and 4) coordination of care; and continuity and transition. Patients in both studies desired background material, knowledgeable staff, family and friend support, personal results, comfortable settings, shorter wait times, and greater scheduling flexibility. Compared with the Altoona study patients, Atlanta study patients reported greater preferences for information from the Internet, need for strong community and online support, difficulties in discussing SLE, emphasis on transportation and child care help during the visits, and concerns related to financial matters; and they placed greater importance on time commitment, understanding of potential personal benefit, trust, and confidentiality of patient data as factors for participation. Using these results, we present recommendations to improve study procedures to increase retention, recruitment, and compliance for clinical trials.
Insights from these two studies can be applied to the development and implementation of future clinical trials to improve patient recruitment, retention, compliance, and advocacy.
Thalidomide is a putative anti‐angiogenesis agent that has significant anti‐tumour activity in haematological malignancies with increased bone marrow angiogenesis, including multiple myeloma (MM) and ...myelodysplastic syndromes (MDS). Increased levels of the mitogen for angiogenesis, vascular endothelial growth factor (VEGF), correlate with worse survival in acute myeloid leukaemia (AML). A phase II trial of thalidomide was conducted in patients with relapsed‐ or refractory‐AML previously treated with cytarabine‐containing regimens. A total of 16 patients with refractory‐ or relapsed‐AML were treated with thalidomide 200–800 mg orally daily (median dose 400 mg daily) for a median of 27 d (range, 3–94 d). Overall, one patient (6%) achieved complete remission (CR) lasting for 36 months, and two patients had a transient reduction in marrow blasts from 8% and 7% to less than 5% in both cases. There was no correlation between reduction in levels of angiogenesis markers and response. Toxicities related to thalidomide were significant, and precluded dose escalation beyond 400 mg orally daily in most patients. Although there appears to be some evidence of biological activity, single agent thalidomide is not an optimal choice of therapy for salvaging patients with relapsed‐ or refractory‐AML. Thalidomide analogues with more potent immunomodulatory activities and more favourable toxicity profiles may offer more promise as anti‐AML therapy.
Imágenes en oncología: generalidades y aplicaciones Andrés O., Brien S.; David Ladrón, De Guevara H.
Revista Médica Clínica Las Condes,
July 2013, 2013-07-00, 2013-07-01, Letnik:
24, Številka:
4
Journal Article
Recenzirano
Odprti dostop
Las imágenes tienen un rol fundamental en la oncología actual, que incluye el diagnóstico, etapificación, evaluación de respuesta al tratamiento y diagnóstico de complicaciones. El examen de mayor ...importancia en estos pacientes es la Tomografía Computada, que tiene un alto rendimiento y resolución espacial, es rápida y disponible en los distintos centros. Otros exámenes son de ayuda complementaria como el Ultrasonido y la Resonancia Magnética. Los estudios metabólicos, y especialmente los de tipo híbrido como el PET/CT, han mejorado la sensibilidad y especificidad en el estudio de diversas neoplasias, tanto en la etapificación, como en el control de tratamiento y seguimiento. En el futuro, con nuevas técnicas, podremos diagnosticar cánceres en una etapa muy precoz, incluso antes de que se manifiesten clínicamente.
Imaging has a pivotal role in oncology, including diagnosis, staging, response assessment to therapy and the diagnosis of complications. The most important modality is Computed Tomography, with high accuracy and spatial resolution, fast and not so expensive. Other modalities are Ultrasound and Magnetic Resonance. Metabolic studies such as PET/CT have high accuracy in staging, and follow up of different cancers. In the future, newer techniques will be available in order to diagnose even smaller asymptomatic cancers.
Time reversal of seismic wavefields recorded at active volcanoes may provide images of the source process for long‐period (LP) or volcanic tremor events directly, independent of assumptions about ...extent, geometry and mechanics of the source. Time reversal methods involve propagating the original time series from many receiver locations back into the medium. The reversed signals then focus at their origin due to constructive interference, elucidating the source location, extent and radiation pattern. In practice, focusing may be blurred due to inaccurate Earth models or sparse sampling of the wavefield at the surface. Here, we investigate the feasibility of this method for several synthetic volcanic tremor sources and present a gallery of time reversal source images. Wave propagation is computed numerically in a 2D volcano model with realistic topography. Our results indicate that time reversal may be applicable in volcanic settings, possibly yielding new insights into volcano‐seismic LP or tremor sources.
Short tandem repeat polymorphisms (STRP), or microsatellites, are widespread among vertebrate genomes and are useful in gene mapping and population studies due to a high level of length polymorphism. ...We describe here the isolation, characterization, and PCR amplification of 10 microsatellite loci from the domestic cat, Felis catus. The flanking primer sequences were conserved among other Felidae species, and amplification products demonstrated abundant polymorphism in puma, lion, cheetah, and domestic cat. The cheetah sample exhibited the lowest level of polymorphism for these loci among felid species.
Recombinant gp160 derived from human immunodeficiencyvirus type 1 (HIV-1)mB and produced in mammalian tissue culture cells using a vaccinia virus expression system (rgp160-mam) was evaluated as a ...vaccine in combination with alum and deoxycholate adjuvant. Sixty low-risk, uninfected subjects received 12.5 µg, 50.0 µg, or adjuvant control at 0, 1,6, and 12 months in a randomized, double-blind dose-escalation study. A single injection of 200 µg of vaccine was given at 18 months in an open study to 9 vaccinees who had received 50 µg. The vaccine was safe. Six of 16 subjects receiving 50 µg developed neutralizing antibody to HIV-1IIIB. Seven of the 9 boosted with 200 µg of vaccine at 18 months developed neutralizing antibodies. Lymphocyte proliferation to rgp160-mam and baculovirus-derived rgp160 and rgp120 was induced in both groups (12.5 and 50.0 µg) and appeared after the first dose. Further studies with higher doses of rgpl60-mam and vaccines derived from other strains of HIV-1 are warranted.
OBJECTIVETo determine the incidence and causes of drug-induced jaundice in a rural community.
METHODSA retrospective analysis of 800 patients presenting to a single-centre jaundice referral system ...serving a community of 400 000 over a period of 66 months (1998–2004). Standard criteria for drug-induced liver injury were applied to patients with a putative diagnosis of drug-induced jaundice. The incidence rates per prescription of drug-induced jaundice caused by co-amoxiclav and flucloxacillin were derived from local and national annual prescription rates.
RESULTSThe incidence of drug-induced jaundice was 1.27 (confidence limits 0.85–1.8) per 100 000 per annum in a total of 28 patients (17 men, mean age 69 years). Antibiotics were the commonest cause of jaundice (n=21). Of these, co-amoxiclav (n=9) and flucloxacillin (n=7) caused the majority with an incidence rate per 100 000 prescriptions of 9.91 (4.6–18.0) and 3.60 (1.5–7.2), respectively. Co-amoxiclav-induced jaundice was observed more commonly in elderly males (age 65 years, M : F 7 : 2). In those patients with flucloxacillin or co-amoxiclav-induced jaundice, bilirubin ranged from 54 to 599 μmol/l (267 μmol/l) with a resolution of jaundice between 30 and 90 days. Counselling with regard to potential drug-induced liver injury and reporting of the adverse reaction had been performed in 1/28 patients.
CONCLUSIONS8.1% patients with no biliary obstruction and jaundice had a drug-induced and predominantly antibiotic-related aetiology particularly affecting an elderly population. We recommend that all patients receiving co-amoxiclav and flucloxacillin should be counselled before the therapy regarding the potential risk of jaundice and that an alternative antibiotic to co-amoxiclav is used if possible in men over the age of 60 years.
ELBOW PAIN IN A GOLFER Selby, R M.; O??Brien, S J.; Drakos, M C.
Medicine and science in sports and exercise,
05/2002, Letnik:
34, Številka:
5
Journal Article
Subtrochanteric femur fractures result from a variety of mechanisms of injury and underlying pathologies. Radiologists can play a pivotal role by differentiating the etiology of a subtrochanteric ...femur fracture, which assists the orthopedic surgeon in choosing the correct method of treatment. To provide this valuable service, one must be familiar with the characteristic radiologic features of the numerous causative etiologies, ranging from Paget disease to underlying bone lesions to iatrogenic fractures.
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