Designing the PIS research project

Please see this pinned blog post – Patient Information Sheet project – for the background information regarding this project, and to see how this post fits into the project overall.


The planning outlined here is based on the book Designing a Research Project (2010) by Piet Verschuren and Hans Doorewaard, that provides a useful framework that can be applied to the PIS project. The book describes two parts to designing a research project; conceptual design – consisting of the research objective, research framework, research questions and definition of terms; and technical design – consisting of the research strategy, research material and research planning. I will go through each of these in turn for the PIS project. Quotes from the book are in italics; outstanding questions that will need to be addressed during the project are in bold.

Conceptual design – research objective

“An area of the project context that is formulated as an external goal / solution to a practical problem”

“the aim of this proposal is to create a visual and modular PIS for generic PET / MRI studies. … Each module represents a specific step of the study. The PIS is designed to be easily adaptable, with a graphical and simplified appearance, and will include visual solutions” (text from the original proposal document).

The ‘visual solutions’ will be individual images that are themselves adaptable – they can be combined in many different ways and used in other presentations / communications, not necessarily just when communicating with patients.

“Two example PIS’s will be used as templates. The output will be both individual modules and two complete sheets, to serve as examples of what can be done with the modules. The outputs will be in both MS Word and MS PowerPoint format. The outputs will be available to view and download from a website” – from the initial meeting with Dr Nordio and Dr Veronese.

The ultimate objective is to create a methodology that makes it possible for scientists to easily / quickly create a PIS that is more effective at communicating to their patients than the current examples. The outputs of this methodology have two aims – 1. they must be usable, editable and adaptable by the scientists themselves and, 2. they must be capable of creating a visually effective piece of information design in MS software. The two case study PIS’s will be used to test the methodology and show that it works.

Conceptual design – research framework

“A schematic and highly visualised representation of the steps taken in order to achieve the research objective.”

The research object is the PIS. We will confront the existing PIS with the redesigned ‘modular and visual’ PIS. The research perspective has two different angles; 1. is the new PIS easy to use and adapt (scientist’s perspective) and, 2. is the new PIS easy to read and understand (patient’s perspective).

Evaluation research – the use of a criterion is a necessary condition for evaluation – we can evaluate the result of the intervention (product evaluation). Do we need more specific criteria to evaluate the product (the modular PIS) than it just being ‘easier’ to use or to read?

Theoretical framework: 1. key concepts – visual communication / information design, communication between patient & clinician, accessible visual communication. 2. key theories – general information design theory, collaborating with non-designers, communicating health matters to the general public (Zender & other research in this area), creating accessible graphic design (guidelines & research in this area).

Research framework for PIS project
Conceptual design – research questions

“Questions … selected and formulated in such a way that answers will yield the information necessary to accomplish the research objective.”

There are two main research questions, one of which has three sub-questions:

  1. Do the PIS modules provide a better visual communication solution for clinicians than exists at present?
    1. Can a PIS designed for a PET / MRI imaging study be deconstructed into a set of illustrated modules?
    2. Can these modules be successfully created in MS Word and MS PowerPoint?
    3. Can these modules be easily used and adapted by the clinicians themselves?
  2. Do patients find a PIS constructed from the illustrated modules to be easier to read and comprehend than an existing PIS?
Conceptual design – definitions

This research is positioned within the area of visual communication between clinicians and patients in the health sciences. Very specifically, it concentrates on Patient Information Sheets produced for patients taking part in imaging studies at either the Centre for Neuroimaging Sciences at the IoPPN, or the imaging centre at St Thomas’ Hospital, both part of King’s College London.

Two example PIS’s will be used as case studies, one for an MRI imaging study, produced by the CNS, and one for a PET imaging study, produced by St Thomas’s. These are both designed for imaging studies involving adults (no children). Although some of the adults may have a lower than average IQ, they are all capable of giving informed consent to participating in an imaging study.

Technical design – research strategy

“A thorough examination of a complex case – a strategy known as a case study. Research is generally approached along various paths and in a qualitative way.”

The project will be using the two main PIS examples as case studies – they will be examined in great detail and alternate versions will be produced. They will also be used as the starting point to building up a library of modules and a library of images / visual elements that are used to create those modules. There should also be guidelines on how to use the elements and modules, with examples to show what the PIS can look like. Will it be possible to generalise the results from a small, but in-depth, case study project?

Prototype testing – alternate PIS’s will be presented to researchers / clinicians who run imaging studies at KCL. They will be shown how the methodology could work, how the images and elements fit into modules and how the modules are then used to build up a PIS. First draft of the PIS’s will be given to the FAST-R committee for review, and then again for the final draft. Do we already have some feedback from patients and scientists regarding the use of images, etc., in PSI’s? Will we be testing the draft versions on scientists other than Drs Nordio and Veronese?

Technical design – research material

“A plan for gathering research material. The first step is defining the research population (the actual segment of reality that is to be studied). Then select the resources that give information about this population. Resources can be people, objects, situations, media and documents. The last step is to obtain information from these resources via questionnaires, interviews, observation and content analysis.”

The main resource are the example PIS documents, particularly the two template examples. There will be a detailed content analysis of these sheets, the number of sections and what each contains. The next resource is people – researchers and scientists. At first, this will primarily be Drs Nordio and Veronese and there will be frequent email communication and (online) meetings to get feedback. Will there have to be more formal interviews and questionnaires? Feedback from participants will be accessed via the FAST-R service at two points in the research project.

Technical design – research planning

“The plan refers both to processing the research project and writing the research report. Draw up a time schedule with deadlines for various ‘products’ and specify beforehand what activities lead to these products. It is highly valuable to have a mental image of the final report in the form of a table of contents.”

Date Activities
June – Sept 2020– collect PIS examples (GN/MV)
– choose 2 PIS templates to start with (GN/MV)
Sept – Dec 2020– breakdown of templates, identify main components (GN/MV/GB)
– start to design a graphic illustration for each component (GB)
– simplify text to be combined with graphics GN/MV
– send first draft to FAST-R service (need a date for this) GN/MV
– ask REC (Research Ethics Committee) for opinion GN/MV
Dec 2020 – Feb 2021– continue design of PIS templates GB
– design a web-based solution to host PIS GN/MV/GB
– review PIS template based on feedback from FAST-R/REC GN/MV/GB
– send second draft to FAST-R service GN/MV
Feb – May 2021– finalise design of the PIS templates & modules GB
– upload PIS to the website(s) GN/MV
May – June 2021– present project and its outcome at departmental seminar GN/MV/GB
– prepare summary of work completed for grant award GN/MV
Original time schedule from Dr Nordio

Summary of the 7 steps of designing a research project:

  1. Explore the project context of the research project at hand and decide on a single and feasible research objective.
  2. Construct a research framework that gives a general indication of the steps that you plan to take to achieve the research objective.
  3. Examine which information will be useful or necessary in order to achieve the research objective. Then formulate this information into a set of research questions and a conceptual model.
  4. Determine the core concepts of the project and tailor the definitions and operationalisations of the concepts to the research objective and set of research questions.
  5. Determine what research strategy you are going to follow when gathering and processing the material into answers to the questions.
  6. For each research question, examine what type of research material you need in order to arrive at sound answers.
  7. Draw up a research plan that indicates the activities you are going to carry out, when this will take place and which products will result during the separate phases of research.

And some final thoughts on writing up the research project:

“Constructing research design involves trial and error, deciding and reflecting, drafting and revising. Designing iteratively is only possible on paper. While writing, be constantly aware that the writing will need revision at a later time. Drafting and visualising are vehicles for implementing a creative thought process and is a fully normal procedure. The process of designing the research project may even be included in the final report.”

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