PubMed · 9765633
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K Sharples, T R Fleming, S MacMahon, A Moore, I Reid, B Scoggins. 1998-08-28. Monitoring clinical trials.. https://pubmed.ncbi.nlm.nih.gov/9765633/
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Von Hippel-Lindau disease (VHL) is an autosomal dominantly inherited syndrome with high penetrance, characterised by tumours in various organs. The Dutch VHL working group presents guidelines for DNA testing and clinical monitoring, to enhance early detection and treatment of VHL patients in the Netherlands. Diagnosis of VHL is justified in patients presenting with a typical VHL tumour with a positive family history, but patients with a VHL tumour and a negative family history may also have VHL. Diagnosis of VHL can be confirmed by molecular genetic analysis of the VHL gene which is informative in virtually all VHL families. In a patient with (suspicion for) VHL there is an indication for genetic counselling. A protocol for clinical monitoring of VHL is presented and is recommended for: carriers of a VHL germline mutation; members of VHL families with an unknown familial mutation; members of VHL families who decline testing of the familial mutation; patients suspected for VHL, but without a detectable VHL gene mutation.
In these days, more than one clinical trial is mostly performed to evaluate a new treatment or therapeutic intervention. This necessitates a combined evaluation of their results. An integration of evidence from several trials is also helpful to determine the actual knowledge. These are the main goals of meta-analyses. Since the end of the 80s meta-analyses are widely used in clinical research. At the beginning of a meta-analysis, a protocol has to be developed. Similar to a protocol of a clinical trial, the inclusion and exclusion criteria for trials, the hypotheses and the planned analyses have to be fixed. After a careful localization of trials, a combined statistical analysis is performed. An investigation of heterogeneity, i.e., differences between study results, is indispensable. During the last years, the tool meta-analysis has been criticized. The criticism mainly results from poorly conducted meta-analyses which generated results without prespecifying hypotheses or which merely combined study results. Well-planned meta-analyses, on the contrary, have an increasing influence in clinical research.
BACKGROUND AND OBJECTIVE: On-line monitoring of light fluence during intraperitoneal photodynamic therapy (IP PDT) is crucial for safe light delivery. A flat photodiode-based dosimetry system is compared with an isotropic detector-based system in patients undergoing IP PDT. STUDY DESIGN/MATERIALS AND METHODS: Flat photodiodes and spherical detectors were placed side by side in the abdomen, for simultaneous light dosimetry in 19 patients. Tissue phantom experiments were performed to provide a preliminary estimate of the tissue optical properties of the peritoneum. RESULTS: The conversion factor between systems for 630-nm light was found to be 1.7 +/- 0.12. The mu(eff) of the tissues in the abdomen is estimated to vary between 0.5 cm(-1) to 1.4 cm(-1) assuming a mu(s)' = 7 cm(-1). CONCLUSIONS: The measured conversion factor should allow for comparison of light fluences with future clinical protocols that use an isotropic-based detector system. Differences in the optical properties of the underlying tissues may contribute to the variability in light measurements.