Participants and those administering interventions were not blinded to the interventions, but participants were not informed of the specific nature of the other interventions applied to other participating households.
The nurse administered intervention is delivered monthly over the telephone.
Other parties involved in the research, such as the clinicians who recruit patients or administer interventions, are not formally asked for their consent in the same way because they are not deemed to be vulnerable in the way that participants may be.
There was no significant association between whether a practitioner was involved in administering interventions that were part of an EC clinical trial (p = 0.4) and perceived impact of deferred consent on the parent-practitioner relationship.
Enrolled patients will be regularly reassessed by the HELP staff, and nurses and supervised volunteers will administer interventions that are reassigned daily and tracked for adherence.
The rationale for administering these interventions is that effecting a decrease of afferent nociceptive information in the cranio-cervical region (i.e. a peripheral mechanism) will lead to a decrease of peripheral sensitization or sensitization of the trigemino-cervical nucleus caudalis [12, 13].
However, it is important to underline that due to the high daily dose administered, the intervention was demanding.
Having been conceived as a pilot study, the main ones are the fact that the geriatrician who administered the intervention was not blinded to group assignment, the relatively small sample size and the short duration of the follow-up period.
The data show that the combination of assessing infant's condition and administered interventions (Combined-Apgar) is better (to predict death) than the description of condition or interventions alone.
Observations from therapists administering the intervention were that the level of adaptive equipment in use in the participating care homes was relatively low and highly variable.
If dignity therapy proves to be effective, it could be a relatively brief and easy to administer intervention that could be made available to people with MND.
