Consumer input helps shape and improve research protocol

Tuesday 18 July 2017

A recent Mater Research protocol submitted to the National Health and Medical Research Council (NHMRC) has demonstrated the vital role consumers play in shaping and improving research trials.

Mater Researcher and Staff Specialist in Palliative Care Dr Phillip Good is seeking funding for a study to investigate the use of medicinal cannabinoids in palliative care and sought consumer input, via the Mater Research Office, to assess:

  • the practicality and ethics of the recruitment approach
  • study requirements including assessment tools
  • study outcomes
  • the qualitative component
  • how the study could be improved.

During the design phase of the project, Dr Good engaged with Health Consumers Queensland (HCQ) and with the Mater Cancer Care Centre (MCCC) to seek patients or carers willing to partner on the project.  Through HCQ and MCCC, a consumer panel was organised to review and critique the research proposal.

“Detailed comments were received from consumer representatives expressing support for the project, but also raising important issues and concerns,” Dr Good said.

Key issues raised by consumers included:

  • the need for carer assistance to complete forms and help with informed consent
  • the continuation of supplies post trial
  • the speed of titration
  • the time taken to complete recruitment
  • the number of questionnaires
  • concern around the threshold for side-effects precipitating study withdrawal and the confounding influence of symptom load with rapidly progressive disease
  • the possibility of withdrawal symptoms post study.

Dr Good said that the consumer feedback was integral to the development of the protocol.

“The feedback we received has enabled us to refine the protocol to minimise the demands on participants and to ensure they are properly informed about the trial and the ongoing impacts once the trial has finished,” Dr Good said.

“We addressed all the issues raised in the protocol and will take on board other points when we have received funding to commence the trial”.

The following changes were made to the proposal to address the consumer feedback:

  • The number and length of questionnaires was reduced to minimise demands on participants
  • Added strategy to manage drug withdrawal, in case participants develop drug dependence. All investigators will be certified cannabis prescribers in order to facilitate post trial supply, if needed.
  • Carers will be encouraged to contribute to the consent process and to help participants conform to trial requirements.
  • Information regarding participants’ cancer types will be captured at baseline to allow any trends regarding response in specific tumour types to be identified for future research.
  • It will be made clear to participants in the consent process that the investigators are unlikely to have funding to continue drug supply post-trial. A small supply will be available, in the case of withdrawal, and we will facilitate ongoing supplies through established channels at the conclusion of the study for those patients who wish to continue.

“The consumer feedback also identified a lack of clarity in the draft proposal regarding participant’s rights and safeguards, which has been addressed in the revised proposal,” Dr Good said.

“In addition, we will engage with consumers in development of the patient information and consent form to ensure that it is clear to participants that they will be fully informed regarding the study objectives, their obligations and risks, and to ensure absolute clarity regarding their option to discontinue participation for any reason, and that withdrawal will not impact their right to receive best quality care.”

Deputy Director Mater Research Prof Mike McGuckin said that Mater Research is committed to conducting exceptional health research and translating outcomes to benefit patients and their communities.

“Our approaches to research and clinical service delivery are unified by an underlying commitment to deliver healthcare which is responsive to the needs and preferences of individual patients and their carers,” Prof McGuckin said.

“The overall goal of Mater Research’s engagement strategy in this and other research projects is to establish an ongoing dialogue, providing continuing input to the project team regarding patients’ needs and concerns, and giving the researchers the opportunity to inform the relevant stakeholders regarding the progress of their research and its implications for cancer care.”