| 1. |
- Province, M. A., et al.
(author)
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CYP2D6 Genotype and Adjuvant Tamoxifen : Meta-Analysis of Heterogeneous Study Populations
- 2014
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In: Clinical Pharmacology and Therapeutics. - New York, USA : Nature Publishing Group. - 0009-9236 .- 1532-6535. ; 95:2, s. 216-227
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Journal article (peer-reviewed)abstract
- The International Tamoxifen Pharmacogenomics Consortium was established to address the controversy regarding cytochrome P450 2D6 (CYP2D6) status and clinical outcomes in tamoxifen therapy. We performed a meta-analysis on data from 4,973 tamoxifen-treated patients (12 globally distributed sites). Using strict eligibility requirements (postmenopausal women with estrogen receptor-positive breast cancer, receiving 20 mg/day tamoxifen for 5 years, criterion 1), CYP2D6 poor metabolizer status was associated with poorer invasive disease-free survival (IDFS: hazard ratio = 1.25; 95% confidence interval = 1.06, 1.47; P = 0.009). However, CYP2D6 status was not statistically significant when tamoxifen duration, menopausal status, and annual follow-up were not specified (criterion 2, n = 2,443; P = 0.25) or when no exclusions were applied (criterion 3, n = 4,935; P = 0.38). Although CYP2D6 is a strong predictor of IDFS using strict inclusion criteria, because the results are not robust to inclusion criteria (these were not defined a priori), prospective studies are necessary to fully establish the value of CYP2D6 genotyping in tamoxifen therapy.
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| 2. |
- Coorevits, Pascal, et al.
(author)
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Electronic health records : new opportunities for clinical research
- 2013
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In: Journal of Internal Medicine. - : Wiley-Blackwell. - 0954-6820 .- 1365-2796. ; 274:6, s. 547-60
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Journal article (peer-reviewed)abstract
- Clinical research is on the threshold of a new era in which electronic health records (EHRs) are gaining an important novel supporting role. Whilst EHRs used for routine clinical care have some limitations at present, as discussed in this review, new improved systems and emerging research infrastructures are being developed to ensure that EHRs can be used for secondary purposes such as clinical research, including the design and execution of clinical trials for new medicines. EHR systems should be able to exchange information through the use of recently published international standards for their interoperability and clinically validated information structures (such as archetypes and international health terminologies), to ensure consistent and more complete recording and sharing of data for various patient groups. Such systems will counteract the obstacles of differing clinical languages and styles of documentation as well as the recognized incompleteness of routine records. Here, we discuss some of the legal and ethical concerns of clinical research data reuse and technical security measures that can enable such research while protecting privacy. In the emerging research landscape, cooperation infrastructures are being built where research projects can utilize the availability of patient data from federated EHR systems from many different sites, as well as in international multilingual settings. Amongst several initiatives described, the EHR4CR project offers a promising method for clinical research. One of the first achievements of this project was the development of a protocol feasibility prototype which is used for finding patients eligible for clinical trials from multiple sources.
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| 3. |
- Hesser, Hugo, et al.
(author)
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Therapist-assisted Internet-delivered cognitive behavior therapy for depression and anxiety : Translating evidence into clinical practice
- 2014
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In: Journal of Anxiety Disorders. - : Elsevier. - 0887-6185 .- 1873-7897. ; 28:8, s. 884-893
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Journal article (peer-reviewed)abstract
- This dissemination study examined the effectiveness of therapist-assisted Internet-delivered Cognitive Behavior Therapy (ICBT) when offered in clinical practice. A centralized unit screened and coordinated ICBT delivered by newly trained therapists working in six geographically dispersed clinical settings. Using an open trial design, 221 patients were offered 12 modules of ICBT for symptoms of generalized anxiety (n=112), depression (n=83), or panic (n=26). At baseline, midpoint and post-treatment, kpatients completed self-report measures. On average, patients completed 8 of 12 modules. Latent growth curve modeling identified significant reductions in depression, anxiety, stress and impairment (d=.65-.78), and improvements in quality of life (d=.48-.66). Improvements in primary symptoms were large (d=.91-1.25). Overall, therapist-assisted ICBT was effective when coordinated across settings in clinical practice, but further attention should be given to strategies to improve completion of treatment modules.
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