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Project objectives

The RESET registry is a clinical registry, so the target parameters (endpoints) of all defined subprojects are related to the clinical condition of patients and to the results of applied therapy:

  • survival parameters
    • overall survival
    • survival to the emergence of clearly defined complications or risk events (time-to-event analyses)
  • assessment of therapy results (various indicators of treatment response)
  • assessment of adverse effects of therapy (toxicity scoring, adverse events / adverse effects)

The objectives of the RESET project are defined and realized within individual diagnosis groups. In general, they involve the following trends in research and monitoring:

  1. Identification of patients who for whatever reason are not treated by modern therapy, recognition of causes of this phenomenon, trends description.
  2. Morbidity and mortality comparison in different group of patients, comorbidity evaluation in relation to the basic diagnosis. Reference comparison of these data with demographic characteristics of the whole population.
  3. Comparison of effectiveness of therapeutic strategies used in routine practice with results from trials. Retrospective comparison of results and security of various therapeutic strategies.

Meeting the targets

Since 2008, the following objectives (as defined at the time of project start) have been met:

  1. Electronic documentation of patients has been defined; this documentation is fully compatible with international standards.
  2. On-line system for multicentre data collection has been established, complying with both safety aspects and legal aspects regarding such type of data collection, as required by the legislation and health care facilities.
  3. Database system of the registry allows to update data forms, to initiate new subproject and to perform automatic reporting of data.
  4. Four Czech and four Slovak centres dealing with treatment of patients with expansions in sellar regions have agreed to participate in the project.
  5. Retrospective collection of data on patients from involved centres was the first step, followed by prospective collection of data on newly diagnosed patients.
  6. Project results have been regularly presented at workshops and conferences.

Long-term objectives of the project

Long-term project objectives have been also partly met, particularly the following ones:

  1. Identification of selected groups of patients with sellar expansions (with differentiations to exact diagnoses) and getting a basic overview on their numbers and treatment options.
  2. Realization of subproject as defined for different diagnoses. These subprojects are mainly focused on the following areas: acromegaly, prolactinomas and Cushing's disease.
  3. Based on the acquired data, attempt to optimize therapy approaches, which could possibly direct patients into specialized centres with interdisciplinary continuity (which does not always happen at present). Improvements of therapeutic possibilities are widely expected.
  4. In later stages of registry development, identification of data communication with field doctors, using data forms developed for their purposes. The benefits would include more relevant data from the epidemiological point of view as well as materials allowing the assesment and predictions of capacity costs and financial costs of treatment.