Data collection

You probably do not consider it inevitable that patients are involved in the implementation. Yet their input can be important to various types of research. It can help make information materials and questionnaires more relevant. Moreover, patients can also help explain data and identify important variables.

Furthermore, contact with patients throughout the data collection ensures that the patients’ standpoint as well as the objectives and outcome measures are also kept in mind during this phase. This keeps the objective clear for everyone, while the collection of data is more focused.

It is easier to ensure involvement in data collection in research that is ‘close to the patient’, such as clinical studies, implementation research or qualitative research.

However, involvement can also be of added value in more fundamental research. Frequent discussions with a research partner, for example, can inspire both researchers and patients, which in turn can result in new ideas.

It makes perfect sense to us that experts by experience should contribute their thoughts at all levels.

I conducted and analysed the interviews together with an expert by experience. She was able to make better contact with the patients and interpret the answers better because she knew and understood their mindset. She really took the patients’ standpoint in my research to a higher level.

Patients can be beneficial to various practical and content-related matters in terms of data collection:

• determining and monitoring variables to be measured and outcome measures
• providing context to data (including statistics)
• assessing the suitability of informational material
• assessing the relevance and suitability of questionnaires
• facilitating interviews and focus groups as co-researcher
• conducting literature studies

Read the experiences with a patient panel in a clinical trial.

This can include the checking of information letters or questionnaires – are they clear for patients?

Furthermore, you can ask about patients’ priorities and standpoints to determine the main aspects to focus on. Are there particular interrelationships that patients are curious about, for instance? Or are there outcome measures that they consider important?

The patients’ standpoint also benefits statistical research. Experience-based knowledge provides context for the numbers in statistical analysis and when determining the variables to be measured. You can read more about this in this publication by Hannigan (2018).

Experiences have also been gained with involving patients in literature studies. SCIE in Great Britain has collected a number of these.

Patients can also contribute to data collection as co-researchers. An expert by experience as a co-interviewer can, for example, produce better interviews and important information:

We had a co-interviewer in our study with an acquired brain injury. The questions that she asked made me realise that brain injury is more than just a medical diagnosis. Her experience gave her an understanding of the different processes and phases that people with an acquired brain injury go through. This is something that I did not have.

There are various ways to structure this type of input from patients.

You can give patients a permanent place in the research, and thus during the data collection. This could be as a patient-research partner or on an advisory committee.

In addition, you can also opt for consulting patients at regular intervals about relevant subject matters, for example through a focus group or workshop. Here you can, for example, place data in the context of the patients’ daily lives or assess the data against a broader and more diverse group of patients. This can therefore also be a validity step. 

The ‘FIRST’ model is a good model for achieving sustainable relationships between patients and researchers. It recognises the dynamics in the collaboration and focuses on reflection and empowerment. The model describes five practical components that enable collaboration on an equal footing between patients and researchers:
(1) facilitate
(2) identify
(3) respect
(4) support
(5) training
The model has been evaluated within the context of clinical rheumatology research.

It is important to continue to have discussions together throughout the project. Is the study still heading in the direction you had in mind? Are any adjustments necessary?

Include patients in the interim analysis of the results and in determining the future plan of the project. Has your client set certain milestones for your research? Inform patients of these as well.

In clinical trials, patients can be instrumental in defining and interpreting patient-related outcomes (PROs), i.e. “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician”.

PRO methods, such as questionnaires, are increasingly being used in clinical research to better understand the efficacy of a treatment.

The UK COMET initiative (Core Outcome Measures in Effectiveness Trials) is increasingly trying to include patients in the drafting of outcome measures for clinical trials. Read about their experiences.