PubMed · 15242006
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S A Fazlani. 2004. Protocols for exercise during pregnancy.. https://pubmed.ncbi.nlm.nih.gov/15242006/
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The von Willebrand Disease Prophylactic Network (vWD PN) has been initiated to study the natural history of vWD bleeding, and to prospectively study the role of von Willebrand Factor (vWF) concentrate prophylaxis in vWD. Patients with all types of vWD in need of treatment with vWF concentrate will be enrolled into the study. Quality of life will be measured and safety and efficacy will be monitored at pre-determined intervals. Between February 2005 and July 18, 2005, 62 investigators from Europe and North America participating in the vWD PN, and 61 have submitted census data. A total 5343 patients have been identified for enrollment, and of these, 991 patients were treated with plasma-derived products in the preceding 12 months, and 99 patients have received prophylaxis, predominantly for joint-related bleeds. The vWD PN aims to further elucidate the role of vWF concentrate prophylaxis in vWD and to identify patients most likely to benefit from prophylaxis.
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BACKGROUND: Choosing an adequate measurement instrument depends on the proposed use of the instrument, the concept to be measured, the measurement properties (e.g. internal consistency, reproducibility, content and construct validity, responsiveness, and interpretability), the requirements, the burden for subjects, and costs of the available instruments. As far as measurement properties are concerned, there are no sufficiently specific standards for the evaluation of measurement properties of instruments to measure health status, and also no explicit criteria for what constitutes good measurement properties. In this paper we describe the protocol for the COSMIN study, the objective of which is to develop a checklist that contains COnsensus-based Standards for the selection of health Measurement INstruments, including explicit criteria for satisfying these standards. We will focus on evaluative health related patient-reported outcomes (HR-PROs), i.e. patient-reported health measurement instruments used in a longitudinal design as an outcome measure, excluding health care related PROs, such as satisfaction with care or adherence. The COSMIN standards will be made available in the form of an easily applicable checklist. METHOD: An international Delphi study will be performed to reach consensus on which and how measurement properties should be assessed, and on criteria for good measurement properties. Two sources of input will be used for the Delphi study: (1) a systematic review of properties, standards and criteria of measurement properties found in systematic reviews of measurement instruments, and (2) an additional literature search of methodological articles presenting a comprehensive checklist of standards and criteria. The Delphi study will consist of four (written) Delphi rounds, with approximately 30 expert panel members with different backgrounds in clinical medicine, biostatistics, psychology, and epidemiology. The final checklist will subsequently be field-tested by assessing the inter-rater reproducibility of the checklist. DISCUSSION: Since the study will mainly be anonymous, problems that are commonly encountered in face-to-face group meetings, such as the dominance of certain persons in the communication process, will be avoided. By performing a Delphi study and involving many experts, the likelihood that the checklist will have sufficient credibility to be accepted and implemented will increase.