SJS/TEN is a devastating condition resulting from a severe immune mediated mucocutaneous response which normally occurs as an adverse reaction to medications. In the acute phase, the patient presents with a febrile illness, followed by skin and mucous membrane necrosis and detachment. The global clinical and financial burden of SJS/TEN is considerable with significant long-term multisystem physical and mental health complications. Some of the most common physical sequelae include cutaneous, respiratory, and ocular problems. Long lasting psychological effects have been reported; feelings such as distress, anxiety and depression. Many SJS/TEN patients develop quality of life disruptions such as intense fear of hospitalisation and medications, relationship, and self-image difficulties. SJS/TEN has a long-term impact on survivors and it is important to monitor same at acute phase and thereafter. Finlay (2017) notes the importance of integrating the assessment of QoL impairment into routine clinical dermatology practice.
Little is known about appropriate QoL outcome measures to assess changes in the specific experiences of SJS/TEN survivors. Current QoL measures fail to do this. The Dermatology-Life-Quality-Index does not include fear of taking medication or of doctors which was referred to in the evidence. Many rare skin diseases lack specific QoL outcome measures . Consequently, there is a need to prioritise research in this area. The aim of this research is to develop and psychometrically test a QoL outcome measure for adults with SJS/TEN. Using DeVellis (2016) two phase instrument development framework, the study has four objectives namely to:
Establish the evidence regarding concepts used in HRQoL literature
Reach a consensus on key dimensions for QoLTEN amongst experts
Pilot test the QoLTEN outcome measure
Undertake a nested process evaluation, using Normalisation Process Theory, to help guide and understand how this new outcome measure becomes part of normal practice
