HTA agency, Poland

Protocol

In terms of HTA, protocol is a detailed plan that by providing a list of steps or procedures, guides the development of full HTA report. A protocol usually contains: introduction, objectives of the report, methodology to be followed (ex. inclusion criteria for clinical trials, methodology of data extraction and their analysis), role of each person involved in the process, detailed search strategy, time frame for all stages of the developing full HTA process. The objective of a protocol is to inform all stakeholders and other HTA agencies about the undertaken HTA report and avoid the unnecessary doubling of the work. Protocol also enables reviewer to verify whether the whole process has been carried out properly, and if yes it enables others to update search on topic in question, by using search strategy determined in protocol.

In accordance with the Order of the Director of the AHTAPol of the 27th of March 2007 on preparing recommendations regarding financing medical technologies from public sources, protocol shall constitute a fixed step in procedures of developing full HTA report, implemented by the AHTAPol.

As we have no good example of protocol developed by AHTAPol yet, but we consider that the best example of a protocol would be any protocol regarding systematic reviews provided by Cochrane Collaboration.

Guidelines

There is no doubt, that the purpose of a guideline is to assist practitioners and patients in making decisions about healthcare interventions in managing a specific health condition. Guidelines are produced through different processes and their quality varies. Evidence based guidelines are (usually published) documents based on a systematic review of existing literature and appraisal of the evidence, which are updated regularly. The level of evidence for each existing guideline depends on the quality and amount of existing studies and on uniformity of this evidence. Guidelines need to be updated at regular intervals as the results of new research may either strengthen or weaken the evidence on effectiveness or safety of the medical technology in question.

In terms of HTA, the AHTAPol has developed the Guidelines conducting Health Technology Assessment that has recently been implemented into practice with the Order of the Director of AHTAPol of 27th of March 2007. The basic objective of this guidelines is to assure a high quality standard of conducting health technology assessment in Poland, namely a high reliability credibility of assessments carried out in accordance with the guidelines. The second, equally important objective is to assure the highest possible repeatability of results and to limit differences occurring in assessments of the same technology by different authors, as well as to increase verifiability of results of assessments made for the use of the Agency.

The guidelines for conducting health technology assessments are aimed at:

• enabling the Consultative Council to formulate their recommendations according to transparent and open principles, based on reliable and credible assessments of medical technologies,
• enabling decision-makers, on the basis of presented recommendations, to establish to what extent they can rely on those recommendations, i.e. to what extent the recommendations are justified and credible.

Guidance

In Poland there are few clinical practice guidelines, the most common document that serves as assistance for practitioners in making decision on adequate management of specific conditions is “guidance”. The guidance is usually developed by a consensus of clinical experts, usually based on the reference guidelines developed in other countries, which quality of evidence for making recommendations has been approved and acknowledged.

Guidance refers to best practice used at local setting (sometimes region, sometimes hospital). For instance the practice used in treating one condition may slightly differ from one hospital to another, although both are accepted and in accordance with guidelines.

Example:
One hospital may treat a mild relapse of multiple sclerosis with regard to its severity and use 0,5g of methylprednisolone administered i.v. for 5 consecutive days for mild relapse and 1,0 g of methylprednisolone administered i.v. for 3 consecutive days for medium and severe relapses, whereas other hospital may administer 1,0 g methylprednisolone i.v. for 3 consecutive day with no regard to “severity” of a relapse.

Advice

In our hierarchy of sources of recommendation for medical technology, advice places at the very bottom, as often it’s a recommendation made by an individual, who is guided by his subjective opinion and beliefs based on own experience and not necessarily based on EBM reasoning.