Phase 4 Materials used to validate the Framework

In this section, the materials and methods selected to validate the framework, are presented.

3.2.5.1 Why a case study?

Case study research is the best method to use when the objective of the research is to understand a complex issue.

Researchers have used this method for different disciplines, with a big prevalence of social sciences, to examine real-life situations and provide insights towards application of ideas and extension of methods.

Yin defines the case study research method as “an empirical inquiry that investigates a contemporary phenomenon within its real-life context; when the boundaries between phenomenon and context are not clearly evident; and in which multiple sources of evidence are used” (Yin, 1984; Yin, 2010).

Critics are not scarce to this methods: there is the risk that not solid grounds for reliability or generality of results can be generated or that the exposure to study biases findings, while others suggest this method is useful only as an exploratory tool. Important case study researchers have written about this method and suggest techniques for organizing and conducting research successfully. Six steps are usually suggested when conducting a case study:”

1. Determine and define the research questions: case study research generally answers one or more questions which begin with "how" or "why."

2. Select the cases and determine data gathering and analysis techniques: during the design phase of case study research, the researcher determines what approaches to use in selecting single or multiple real-life cases to examine in depth and which instruments and data gathering approaches to use. Selecting multiple or single cases is a key element, but a case study can include more than one unit of embedded analysis. This type of case study involves two levels of analysis and increases the complexity and amount of data to be gathered and analysed.

3. Prepare to collect the data: case study research generates a large amount of data from multiple sources, therefore, systematic organization of the data is important to prevent the researcher from becoming overwhelmed by the amount of data and to prevent the researcher from losing sight of the original research purpose and questions. Good investigators review documents looking for facts, but also read between the lines and pursue collaborative evidence elsewhere when that seems appropriate. Investigators need to be flexible in real-life situations and not feel threatened by unexpected change, missed appointments, or lack of office

103

space. Investigators need to understand the purpose of the study and grasp the issues and must be open to contrary findings.

4. Collect data in the field: the researcher must collect and store multiple sources of evidence comprehensively and systematically, in formats that can be referenced and sorted so that converging lines of inquiry and patterns can be uncovered.

5. Evaluate and analyse the data: the researcher examines raw data using many interpretations in order to find linkages between the research object and the outcomes with reference to the original research questions. Throughout the evaluation and analysis process, the researcher remains open to new opportunities and insights. The case study method, with its use of multiple data collection methods and analysis techniques, provides researchers with opportunities to triangulate data in order to strengthen the research findings and conclusions.

6. Prepare the report: exemplary case studies report the data in a way that transforms a complex issue into one that can be understood, allowing the reader to question and examine the study and reach an understanding independent of the researcher. The goal of the written report is to portray a complex problem in a way that conveys a vicarious experience to the reader.”

3.2.5.2 Design of the Case Study: participant observation.

“Participant observation is the process enabling researchers to learn about the activities of the people under study in the natural setting through observing and participating in those activities. It provides the context for development of sampling guidelines and interview guides” (De Walt & De Walt, 2002).

Schensul et al. define participant observation as "the process of learning through exposure to or involvement in the day-to-day or routine activities of participants in the researcher setting" (Schensul et al., 1999).

Bernard defines participant observation as “the process of establishing rapport within a community and learning to act in such a way as to blend into the community so that its members will act naturally, then removing oneself from the setting or community to immerse oneself in the data to understand what is going on and be able to write about it” (Bernard, 1994).

More elements than just observation are present, according to Bernard, when the observant is also a participant; observation, natural conversations, and interviews of various sorts, checklists, questionnaires, and unobtrusive methods.

“Participant observation is characterized by such actions as having an open, non-judgmental attitude, being interested in learning more about others, being aware of the propensity for feeling culture shock and for making mistakes, the majority of which can be overcome, being a careful observer and a good listener,

104

and being open to the unexpected in what is learned” (DeWALT & DeWALT, 1998).

DeWALT and DeWALT (2002) believe that "the goal for design of research using participant observation as a method is to develop a holistic understanding of the phenomena under study that is as objective and accurate as possible given the limitations of the method”.

Validity is stronger with the use of additional strategies used with observation, such as interviewing, document analysis, or surveys, questionnaires, or other more quantitative methods.

Participant observation can be used to help answer descriptive research questions, to build theory, or to generate or test hypotheses (DeWALT & DeWALT, 2002).

DeMUNCK and SOBO (1998) provide several advantages of using participant observation over other methods of data collection:

 it affords access to the "backstage culture";

 it allows for richly detailed description, which they interpret to mean that one's goal of describing "behaviours, intentions, situations, and events as understood by one's informants" is highlighted;

 it provides opportunities for viewing or participating in unscheduled events.

 it improves the quality of data collection and interpretation;

 it facilitates the development of new research questions or hypotheses. DeMUNCK and SOBO also share several disadvantages:

 the researcher may not be interested in what happens out of the public eye and that one must rely on the use of key informants.

 The MEAD-FREEMAN controversy illustrates how different researchers gain different understanding of what they observe, based on the key informant(s) used in the study.

 Problems related to representation of events and the subsequent interpretations may occur when researchers select key informants who are similar to them or when the informants are community leaders or marginal participants (DeMUNCK & SOBO, 1998).

To alleviate this potential bias problem, Bernard suggests pretesting informants or selecting participants who are culturally competent in the topic being studied (Bernard, 1994).

The degree to which the researcher involves himself/herself in participation in the culture under study makes a difference in the quality and amount of data he/she will be able to collect. GOLD (1958) has provided a description of observer stances that extend Buford JUNKER's explanation of theoretical stances for researchers conducting field observations:

105 1. “At one extreme is the complete participant, who is a member of the group

being studied and who conceals his/her researcher role from the group to avoid disrupting normal activity. The disadvantages of this stance are that the researcher may lack objectivity, the group members may feel distrustful of the researcher when the research role is revealed, and the ethics of the situation are questionable, since the group members are being deceived.

2. In the participant as observer stance, the researcher is a member of the group being studied, and the group is aware of the research activity. In this stance, the researcher is a participant in the group who is observing others and who is interested more in observing than in participating, as his/her participation is a given, since he/she is a member of the group. This role also has disadvantages, in that there is a trade-off between the depth of the data revealed to the researcher and the level of confidentiality provided to the group for the information they provide.

3. The observer as participant stance enables the researcher to participate in the group activities as desired, yet the main role of the researcher in this stance is to collect data, and the group being studied is aware of the researcher's observation activities. In this stance, the researcher is an observer who is not a member of the group and who is interested in participating as a means for conducting better observation and, hence, generating more complete understanding of the group's activities.

4. The opposite extreme stance from the complete participant is the complete observer, in which the researcher is completely hidden from view while observing or when the researcher is in plain sight in a public setting, yet the public being studied is unaware of being observed. In either case, the observation in this stance is unobtrusive and unknown to participants”

3.2.5.3 Description of the Case Study.

The case study is related to the R&D&I activities that the LifeStech research group, of the Universidad Politécnica de Madrid has carried out to improve the management of diabetes since January 2008 till the present date,

These activities started when the METABO research project was funded by the European Commission (European Commission, 2008). In this project, a community of stakeholders active in the healthcare sector of different countries of the European Union worked together for almost 5 years to define, implement, deploy and evaluate a new paradigm in the management of Diabetes Mellitus Type 1 and Type 2, in the area of Personalized Health Systems.

The LifeStech group was represented in the METABO project by the author of this research work, who acted as technical manager of the project. After the end of the project (September 2012), the R&D&I activities undertaken in the LifeStech group, in relation to the case study, have continued and are ongoing till the present days. The case study represents a suitable scenario to test the framework, because:

106

 It is about improving the management of diabetes, an important case of chronic disease, given its prevalence, and given the positive effects that the application of the CCM has demonstrated, as mentioned in chapter 1,

 It is based on activities that contain different aspects of the innovation process: applied research, deployment and piloting, as well as organizational, marketing and business-oriented elements.

 It has a retrospective component: this way it is possible to show how the framework works in evaluating past interventions.

 It has a prospective component: this way it is possible to show how the framework influence future directions.

 It is complete, as it contains all the 3 development cycles of innovation.

 It is wide in terms of number of participants, multidisciplinarity and variety of European regions that constitute the project consortium.