<abstract xmlns="http://www.w3.org/1999/xhtml"><p>The introduction of new pharmacotherapy entities in the last decade accentuate the necessity to set up treatment guidelines based on real life evidence. Randomized controlled trials remain golden standard of a research. Data derived from studies aiming on daily clinical practice should bring needed, added value. Disease prevalence growth, due to increased life expectancy, better diagnostic procedures and earlier medical intervention, as well as ever growing demand for highly priced, sophistically produced drugs put stress on healthcare budgets even in developed countries. Large databases commonly called - therapy registries are implemented to collect data on therapy effectivity in terms of effectiveness, safety and patient long-term on therapy survival. Registries importance rose together with biological therapies introduction. New in class molecules entered the market conditionally being obliged to provide additional e.g. safety data. Such procedures require involvement of many different professionals, e.g. physicians, professional medical bodies, IT experts, database administrators, statisticians and government institutions. Paper based, followed by computer based forms were distributed among physicians to collect these data. eHealth technologies provide physicians with centralized, more intuitive applications. The particularities of different diagnosis caused great variations within each specific registry launched. Important information was missing since they were pointed out as optional and many were redundant causing frustration among physicians due to inadequate administrative workload. The main objective of this work was to set up the therapy registry standards and procedures. Methodology of „ideal“ moderate to severe plaque psoriasis biology therapy registry development, introduction, administration and evaluation was prepared to assist any government institution or professional body when planning registry deployment. Electronic application based on widely used MS Excel platform was developed and installed in the biological therapy centers as a standalone application for the pilot use.</p></abstract>

The introduction of new pharmacotherapy entities in the last decade accentuate the necessity to set up treatment guidelines based on real life evidence. Randomized controlled trials remain golden standard of a research. Data derived from studies aiming on daily clinical practice should bring needed, added value. Disease prevalence growth, due to increased life expectancy, better diagnostic procedures and earlier medical intervention, as well as ever growing demand for highly priced, sophistically produced drugs put stress on healthcare budgets even in developed countries. Large databases commonly called - therapy registries are implemented to collect data on therapy effectivity in terms of effectiveness, safety and patient long-term on therapy survival. Registries importance rose together with biological therapies introduction. New in class molecules entered the market conditionally being obliged to provide additional e.g. safety data. Such procedures require involvement of many different professionals, e.g. physicians, professional medical bodies, IT experts, database administrators, statisticians and government institutions. Paper based, followed by computer based forms were distributed among physicians to collect these data. eHealth technologies provide physicians with centralized, more intuitive applications. The particularities of different diagnosis caused great variations within each specific registry launched. Important information was missing since they were pointed out as optional and many were redundant causing frustration among physicians due to inadequate administrative workload. The main objective of this work was to set up the therapy registry standards and procedures. Methodology of „ideal“ moderate to severe plaque psoriasis biology therapy registry development, introduction, administration and evaluation was prepared to assist any government institution or professional body when planning registry deployment. Electronic application based on widely used MS Excel platform was developed and installed in the biological therapy centers as a standalone application for the pilot use.

Centralised Biological Therapy Registry for Moderate to Severe Plaque Psoriasis – Overview and Methodology

Dermatovenereology Clinic of Martin University Hospital, Jessenius Faculty of Medicine, Comenius University, Martin, Slovakia

Acta Medica Martiniana

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

The introduction of new pharmacotherapy entities in the last decade accentuate the necessity to set up treatment guidelines based on real life evidence....

Centralised Biological Therapy Registry for Moderate to Severe Plaque Psoriasis – Overview and Methodology

Publicado en línea: 08 jun 2016

Páginas: 36 - 48

Recibido: 22 sept 2015

Aceptado: 04 abr 2016

DOI: https://doi.org/10.1515/acm-2016-0005

Palabras clave
therapy registry, patient register, plaque psoriasis, biological therapy, effectiveness, safety, eHealth

© 2016 Sutka R et al., published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Centralised Biological Therapy Registry for Moderate to Severe Plaque Psoriasis – Overview and Methodology

Publicado en línea: 08 jun 2016

Páginas: 36 - 48

Recibido: 22 sept 2015

Aceptado: 04 abr 2016

DOI: https://doi.org/10.1515/acm-2016-0005

Palabras clavetherapy registry, patient register, plaque psoriasis, biological therapy, effectiveness, safety, eHealth

© 2016 Sutka R et al., published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Palabras clave
therapy registry, patient register, plaque psoriasis, biological therapy, effectiveness, safety, eHealth