Unit I Thought discussion

Healthcare researchers (particularly those in close contact with patients) have a unique perspective, in that they share the health journey with patients, giving them insight into some of the most personal, emotional and intimate experiences. 

Whilst complimentary to the patient experience, their experience is not equivalent. Only a patient has had to personally experience the illness, the side-effects, and the impact on their physical and mental well-being. Researchers can gain some level of insight into this, but can never fully comprehend or experience it to the same degree as a patient.

Researchers can also have underlying conflicts of interest or pre-conceived views, which may impact (consciously or sub-consciously) on their representation of patients views and needs.

This is why it is important to seek the real patient experience, and not one filtered through the prism that is the researcher's opinion.

KR

adam

Research is, basically, intended to benefit clinical practice. Healthcare researchers need to carry out research on human subjects. The Human subjects then benefit from the findings.

In my experience, several stakeholders - from policy to grass root level - have to be involved at all stages of protocol writing, before research is carried out. Researchers need permission to carryout research. They have, therefore, to have the proposal reviewed by Committees of both experts in the subject as well as lay persons. On the ground, communities have to be consulted for security purposes and for determining the local languages to be used in the informed consent forms and other study documents.

Fliers or adverts may have to be put out in a language that is clear to ordinary/lay people who are potential study participants. Sometimes, Community Advisory Boards consisting of lay people, such as Community and Church leaders and elders who communicate community members’ thoughts or complaints  and return feed back to the community on progress of the study or findings.

Thus, in order to carryout research appropriately, healthcare workers need to involve the wider community of lay stakeholders.  This includes the human research participants or patients.

As the others have already correctly pointed out, despite their clinical expertise and experience in the disease area/scientific discipline, one cannot ever fully understand the patient’s needs without themselves having personal experience of the condition. For this reason, patients are very well placed to advise on the future areas of research which would be of the greatest benefit and relevance to the people it is intended to help. Although important and valuable for obvious ethical and financial reasons, new and effective cure/treatments are a focus of the research projects I work on, however for some conditions, symptom control and improved quality of life may be more of a focus for patients.

Although I think there is much more room for discussion, I wanted to share with you 2 examples that helped me choose a side.

I had the pleasure to listen to Gilly Spurrier-Bernard, president of Melanoma France, speaking about patient involvement in melanoma research at a conference held at our offices last Tuesday. She gave a clear example of the importance of involving patients/carers in early stages of a clinical trial, so that research is relevant to people affected by a condition. Her husband was participating in a melanoma trial and he was experiencing extreme fatigue, a side effect of the treatment he was receiving. However, even though a known side effect, data on fatigue was not being collected in the questionnaires as it was not of interest to the researchers, leaving a gap in knowledge and failing to address what is relevant to patients.

The second example is a personal reflection on the different perspective healthcare workers have compared to that of patients. I think of myself as a dentist that that could greatly empathise with patients I treated. However, I had to realise that I was not fully aware of what my patients were experiencing until I had to undergo dental treatment myself. And between us, it is really unpleasant… :S

I agree that research benefits greatly when patients/public are involved. However, the scope of research is huge and PPI may not be applicable everywhere, mainly in trials led by pharma companies, where other interests and objectives are present.

Hi everyone

I do not believe clinical activities equip healthcare researchers to fully represent and understand patients views or needs without involving them in their research. Regular exposure to patients suffering the 'same' disease can create the illusion of understanding their perspective but this fails to capture an individuals' personal experience. 

As others have suggested, without 'living' with a particular disease it is impossible to fully appreciate the impact on patients' lives and that of their families. It is important that researchers challenge their own arrogance in conducting clinical trials, assuming to know the views and needs of patients involved or thinking of becoming involved in research would be misrepresenting their needs and would demonstrate a lack of understanding.

BW

Stewart

I do not fully agree that this is a misconception. Especially in terms of early phase clinical research. Phase 1 clinical research is the first time a compound is ever given to human subjects. Understanding of pre-clinical data is imperative in writing the protocol. I believe that robust evaluation and examination of trial procedures undertaken by expert and qualified personnel is is essential in ensuring subject safety, therefore in this regard, lay input can be minimised, but this is not to say it should be fully eliminated. In our clinical trials unit, we administer pre, intra and post trial questionnaires that are given to study subjects to quantify their trial experience.  These validated questionnaires are then tabulated and analysed. We are hoping to incorporate the subject experience in the improvement of how we conduct future studies, in terms of improving our information sheets, our consent process, dissemination of trial results, post study medical care if required, involvement in future studies, and safety.

If a picture is worth a thousand words…

I wanted to share with you this 2:52 minutes video that perfectly depicts my side of the discussion.Worth watching, I promise  (sorry about the subtitles though)

“An uplifting story of a man who becomes an extraordinary surgeon, as well as an extraordinary person, once he experiences firsthand what it's like being an ordinary patient.” (The Doctor, 1991)

Very interesting discussion going on and though I join in late , it was wonderful going through the diverse experiences of our class

Based on my own personal experience as a clinical researcher , I agree that it is quite easy to develop a strong false illusion that we know our patients views and needs . I am routinely involved in oncology trials and  I mostly have regular interactions spanning over several months and years with patient enrolled in the projects that I manage . I used to believe that I know all my patients quite well. I was also a firm believer that since research goes through a rigorous process of review for scientific content and ethical concerns by ERC/IRBs that also have 'lay' persons as members so we have adequate representation of patient's point of view in research. I recently had a humbling experience that changed all that.

A pleasant friendly lady enrolled in a phase III oncology trial whom I had been seeing for almost a year was asked to fill in the routine FACT-B (a validated quality of life assessment tool often used in research studies) form at one of the study visits. She said that she would like to know what I think of her quality of life right now and asked me that we should both fill a copy simultaneously and then compare our answers and it was eye opener for me! Here I was thinking that I know her needs and preferences so well and at least 30-40% of our answers did not match. She then went on to explain how that questionnaire was missing few crucial questions related to 'her' quality of life and that in some cases the form was just to not descriptive enough to capture her views on her quality of life

I realized two things that day

The importance of having qualitative research component even while doing quantitative studies (i.e. mixed methods studies)

The value of having patient input in research conduct as well as conceptualization 

I recently wrote to our pharmaceutical sponsor in this regard when they asked for local sites input in how ICFs are developed and translated in local languages . Along with suggestions for improving local language translations I also suggested that they should consider having relevant patient /public groups who give input on research agenda and be involved in pilot testing of documents such as ICFs and QoL assessment forms etc . In my opinion , not only would this improve research outcome this would also create greater public awareness about research and lessen skepticism surrounding pharmaceutical sponsored research that exists in the general public currently

Mariam