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                                        • Appraisal of the quality and accuracy of written consumer health information for patients with chronic myeloid leukaemia on treatment-regimens with dasatinib, nilotinib or imatinib

                                        Appraisal of the quality and accuracy of written consumer health information for patients with chronic myeloid leukaemia on treatment-regimens with dasatinib, nilotinib or imatinib

                                        21
                                        Research area: Oncology

                                        Project leaders: Claudia Wild

                                        Project team: Katharina Hintringer, Jone Gerdvilate
                                        Duration: April 2011 - February 2012

                                        Suggested by: LBI-HTA self-initiative
                                        Language: English
                                        Publication: HTA-Project report No. 52: https://eprints.aihta.at/953/

                                        Background:
                                        With the approval of nilotinib and dasatinib for the first-line treatment of patients with Philadelphia-chromosme positive chronic myeloid leukaemia in the chronic phase (Ph+CML-CP) in 2010, there are now three different chemotherapeutic agents available for the treatment of this indication. Both drugs, nilotinib and dasatinib have been directly compared to the current standard of care, imatinib within phase III pivotal trials. At a median follow-up of 18 months, the estimated overall survival for dasatinib was 96% compared to imatinib 97.9% (DASISION trial) and 98.5% for nilotinib 300mg twice daily, 99.3 for nilotinib 400mg twice daily versus 96.9% for the imatinib group (ENESTnd trial).

                                        Based on the interim efficacy and safety data of these two trials, the question arises which treatment option to choose for which patient and where the patients get the information from. While physicians are still the most important source of health related information for patients, studies show that 80-90% of patients search for additional information about their health issues within the internet and traditional media by themselves. Without access to high quality information about their disease and different treatment options, patients will not be able to make informed choices regarding their therapy. Thus, this project aims to appraise the quality and accuracy of written consumer health information on imatinib, dastatinib and nilotinib for the treatment of Ph+CML-CP.

                                        Aims:
                                        Identification and collection of written (internet and paper-based) consumer health information on imatinib, dasatinib and nilotinib for the treatment of CMLTo identify checklists and criteria to appraise the structural quality and content of patient informationAppraisal of the quality of the identified patient informationAppraisal of the accuracy of the proposed information on efficacy and safety

                                        Research questions:

                                        • What are the sources to identify and comprehensively collect written consumer health information about imatinib, dasatinib and nilotinib?
                                        • What is the most suitable search algorithm within search engines to find the information?
                                        • Which parameters constitute the structural quality of consumer health information?
                                        • Which criteria are relevant to appraise the accuracy of consumer health information?
                                        • Which standardized checklists are available to appraise the quality and accuracy of written consumer health information?
                                        • Do the identified patient information documents provide accurate information about the specific drugs and treatment options?
                                        • To what extend do the patient information meet structural quality requirements?

                                        Methods:

                                        • Identification of consumer health information on imatinib, dasatinib and nilotinib:
                                        • Search within search engines (www.google.com, www.yahoo.com, www.bing.com) with the terms (imatinib, glivec, nilotinib, tasigna, dasatinib, sprycel). For each term a separate search will be conducted and the first 60 links will be checked wether they meet the inclusion criteria (patient information about one of the three drugs for the therapy of CML)
                                        • Directly contact national and European umbrella organisations of patient organisations, medical societies related to leukaemia, health ministries and the Marketing Authorisation Holder of the drugs and ask them to provide their patient information material related to the treatment of CML with these or one of these three drugs.

                                        Appraisal of the quality and accuracy of the information with a suitable quality appraisal instrument (e.g. DISCERN, IPDAS Checklist, …) and by applying criteria for evidence-based patient information.

                                        Time schedule/ milestones:
                                        Aim 1 + 2: April - May 2011
                                        Aim 3 + 4: June - October 2011

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