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Table 2 Defining what a serious adverse event is in your trial

From: What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care

 

ACTION trial

Namaste trial

What is the study population?

Advanced colorectal or lung cancer patients with an approximate 50% one-year survival rate. It would not be unexpected that patients may die or be admitted to hospital while taking part in the trial.

Nursing home residents living with advanced dementia (FAST score 6 or 7). In a previous study evaluating the Namaste Care programme, early deaths (< 2 months) were not uncommon in the advanced dementia population [33].

What are the expected risks?

Patient and/or carer distress due to the intervention and/or completion of questionnaires. The risks were expected to be limited in those countries where advance care planning conversations are considered to be part of routine care and mostly validated questionnaires were being used in the study.

The anticipated risks for residents of taking part were viewed as low as the core elements of the programme are sensory activities that involve music, massage, colour, taste and scents. These core elements are viewed as best practice in dementia and end of life care. A potential risk identified was a skin reaction to Namaste Care activities e.g. massage oils or the actigraphy watch that was being used for data collection, with anaphylaxis being viewed as a potential serious adverse event. Nursing home staff completed proxy questionnaires on behalf of the residents taking part in the study as they lacked capacity.

What events should be reported?

‘We ask you to complete this form for every event in the study that takes a course that is significantly more unfavourable to study participants than foreseen in the normal course of the illness.’

*All hospital stays of at least one night and deaths in both arms of the trial were included in reports for the Data Safety Monitoring Committee.

Only deaths, hospitalisations, life threatening or medically significant/important events related to the intervention or data collection procedures were to be reported as serious adverse events.