4.1 Introduction
This chapter presents details of the background to the study, the research questions, and aims of the study, hypothesis to be tested and research design. Also included are details relating to the study population, sample size estimates, data collection tools, and ethical issues. This is a prospective longitudinal study using a randomised controlled trial, pre and post-test design with mixed methods for data collection and analysis. Although the design of this study is grounded in positivism, the use of mixed methods for data collection and data analysis demonstrate my belief that qualitative and quantitative paradigms are necessary in order to answer the research questions and can be integrated in meeting the aims of the study.
4.2 Background of the Study
In 2001 the Director of the Denis Burkitt Unit had a chance meeting at the Irish Museum of Modern Art (IMMA) with both an ex-patient who had received a stem cell transplant 10 years previously and an ex-nurse from the unit who was now an artist in residence. Following on from the discussion that arose from this meeting and in addition to feedback from patients over the years, it became clear to the Director that the internal environment for patients undergoing stem cell transplantation lacked imagination and stimulation. Patients also complained that views from their windows included an air conditioning plant for the unit (90cms away from the window), waste ground, or an adjacent hospital building that blocked out the sun and ability to see the sky. Although purpose built, the focus of the design clearly had been on its functionality in providing treatments to patients rather than recognition that bright, airy, and visual and mentally stimulating environments are essential for patients recovering from any illness. This is compounded by restrictions for a 4-6 week period on movement and visiting enforced in order to prevent infection.
Shortly after this, an artist working with the human connectedness group in Media Lab Europe heard about the encounter. His work at that time was investigating the defining features of human interaction and how technologies could be adapted to become an integrated part of this process. As a result of reflection on his media lab project and the environmental issues raised in relation to patients in the Denis Burkitt Unit, the artist proposed the construction of a digitally generated ‘virtual window,’ which could be projected on the wall at the foot of the patient’s bed. This ‘virtual window’ was conceptualised as a virtual art gallery that would be constituted with both visual and auditory artworks.
The Director of the unit was enthusiastic about this proposal and believed that art was possibly an effective medium for alleviating the clinical and unresponsive design of the rooms and also for helping patients to adjust psychologically to having a stem cell transplant as treatment for a life threatening illness and possibly surviving it. Once the concept was agreed in principle by the Director of the unit and the artist, a medical physicist employed by the hospital was introduced to the team. His purpose, in conjunction with the Director of the unit, was to act as a link between the artist, who was regarded as an external agent, and the hospital management. A second key aspect to his role was to provide expertise and guidance in terms of the technology, equipment and processes required to make the ‘virtual window’ a reality in the Denis Burkitt Unit. This was named the ‘Open Window’ Project and over the following two years a prototype was developed that met with the hospital’s guidelines on infection control and patient safety. With funding from the Bone Marrow for Leukaemia Trust and other interested groups, ‘Open Window’ became available to patients in summer 2003. The ‘Open Window’ prototype was installed initially in 2 rooms in the Denis Burkitt Unit in 2003.
A main priority for the ‘Open Window’ Project team was to ensure the provision of artworks for the system and to evaluate its effect on patients undergoing stem
cell transplantation. Following a decision to conduct a study to evaluate the psychological effect of ‘Open Window’, approaches were made to the psycho- oncology services in the hospital and Professor Cecily Begley, Director of the School of Nursing and Midwifery, Trinity College to join the research team. Successful grant applications were made to the Irish Cancer Society and Vodafone Foundation Ireland to conduct the evaluation within the context of a randomised controlled trial. The Irish Cancer Society funding facilitated my employment as a research fellow and my role was to develop, conduct and lead the randomised controlled trial to measure the psychological effect of ‘Open Window’ and assess any potential influence it had on participants’ experiences of having a stem cell or bone marrow transplant. My role included liaising with the psycho-oncology services in the Denis Burkitt Unit in relation to the most appropriate psychometric instruments to measure the psychological effect of ‘Open Window’. In order to evaluate participants’ views on ‘Open Window’ and determine whether it influenced their overall experience of having a transplant, I also developed two further instruments and the interview guide. I applied for the position of research assistant on this project because my research interests are communication and patient-centeredness and, as a nurse, I have a particular interest in treatment interventions that represent a patient-centered approach to care. This funding also provided a salary for an artist as a curator for the project. The funding from Vodafone Foundation Ireland was awarded specifically for the further development and installation of an updated ‘Open Window’ system in 8 rooms in the Denis Burkitt Unit in July 2005.
Although St. James’s Hospital has an Arts Committee and employs an Arts Director that supports the ‘Open Window’ project, it exists outside its structures in terms of funding and control. The Arts Director works with the hospital Arts Committee and hospital management in introducing visual and/or performing arts in various locations around the hospital. Funding for my salary for a three period was secure, costs for conducting the trial, data inputting, transcribing of interviews and statistical advice were not available. In 2006, therefore, I
submitted an application to the Irish Cancer Society for a PhD student grant and was awarded €20,000 to cover these costs.
4.3 Purpose of the Study
The purpose of this study is to measure and evaluate the effect of ‘Open Window’ on patients’ psychological well-being and experience of having a stem cell or bone marrow transplant. The primary outcome related to HRQoL and the level of anxiety, depression and distress experienced by participants over time. These were measured using the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith 1983) and the Distress Thermometer (DT) (Roth et al. 1998). The secondary outcome was determining if participants’ experience of having a transplant met their expectations and this was measured using the expectations questionnaire designed specifically for this study.
4.3.1 Research Questions
1. Does ‘Open Window’ have an effect on a patients’ psychological well- being when undergoing stem cell or bone marrow transplant?
Aim: To test the null hypothesis that ‘Open Window’ has no effect on participants’ levels of anxiety, depression or distress over time.
Aim: To measure participants’ level of anxiety, depression and distress before, during, and after stem cell transplantation.
Aim: To conduct sub-group analysis to compare levels of anxiety, depression and between patient undergoing allogeneic and autologous stem cell or bone marrow transplants.
2. Does ‘Open Window’ influence a person’s overall experience of having a stem cell or bone marrow transplant?
Aim: To determine the type of influence, if any, that ‘Open Window’ has on participants’ experiences of stem cell or bone marrow transplantation.
Aim: To identify patients’ perspectives on the primary factors, including ‘Open Window’ if applicable, that influenced their experience.
3. Does ‘Open Window’ have a long-term effect on a person’s experience of having a life threatening illness?
Aim: To ascertain if participants continue to use art in any way in their lives after the experience of having a stem cell or bone marrow transplant.
4.4 Hypothesis to be tested
‘Open Window’ has no effect on patients’ levels of anxiety, depression, or distress when undergoing a stem cell or bone marrow transplant.
4.5 Study Design
This study is a randomised controlled trial using a pre-test/post-test design and mixed methods for data collection and analysis. This experimental design is a quantitative research approach, which is grounded in the positivist paradigm. This paradigm, or philosophy as it is also referred to, originated in the natural sciences and researchers that use it to underpin and guide their research believe that knowledge is developed through systematic observation and measurement. Research designs based on this philosophy reflect the view that social and physical phenomena are equally observable and measurable and that all research should be objective. The key assumption associated with positivism as a research methodology is that knowledge is independent and objective, and can be used to explain, predict or control a phenomenon regardless of its social or cultural context (Richardson 2000, Burke Johnson and Onwuegbuzie 2004). On the basis of these beliefs, quantitative researchers conduct research in order to determine cause-and-effect relationships and generalise about a phenomenon (Knapp 1998).
4.5.1 Quantitative Research Designs
There are 4 well-recognised designs associated with quantitative research, classified as descriptive, correlation, quasi-experimental and experimental.
4.5.1.1Descriptive Research
Descriptive research is used to generate knowledge on topics about which little is known. The purpose of this research design is to explore and describe concepts and identify relationships within or between phenomena (Burns and Grove 1997). One of the key types of descriptive research is the survey. This research approach facilitates the collection of large amounts of data in relation to the practices, opinions, attitudes and other characteristics of particular populations or groups. Knapp (1998) describes surveys as useful but superficial with careful consideration needed in relation to sampling and measurement issues; this is perhaps an issue for all research designs and not just descriptive research. Burns and Grove (2005) and Parahoo (2006) suggest that the advantage of surveys is that they can be administered to large populations, often include a wide range of topics and are used for descriptive and correlation studies. This study used a survey questionnaire in order to assess participants’ views of ‘Open Window’ on a range of issues; for example, how it made them feel, personal preferences and when and how often they turned it on. A 31-item questionnaire was developed for this purpose and details of its development and testing are discussed in section 4.9.3.
4.5.1.2Correlational Research
Correlational research is a design used to examine relationships between variables but does not actively manipulate the independent variable(s). The purpose of this design is to establish the type (positive or negative) and degree (strength) of the relationship, which can range from -1 (negative correlation) to +1 (positive correlation) with 0 representing no correlation or relationship (Burns and Grove 1997, Knapp 1998). Knapp (1998) classifies correlational studies as ordinary or comparative. Ordinary correlational studies are exploratory, predictive or explanatory. Comparative studies can be prospective, cross- sectional, retrospective, and include case control studies. Although some manipulation of variables may occur in these studies, causality cannot be clearly stated; however, this design is useful for conducting research in contexts where
experimentation is not feasible (Knapp 1998). This design was not appropriate for this study because the absence of control limits its ability to establish cause and effect (Polit et al. 2001).
4.5.1.3Experimental Research
Experimental research is also used to investigate cause-and-effect relationships between dependent and independent variables; however, unlike the research designs already described, this is conducted under highly controlled conditions (Burns and Grove 1997). In order to be classified as an experiment, a research design needs to include three components: manipulation, control and randomisation. The purpose of these components is to control for extraneous variables that could threaten the internal validity of the study. Manipulation refers to the control of the independent variable and observation of its effect on the dependent variable by the researcher. An example of this in health care is the introduction of a treatment intervention (independent variable) to one group of study participants while simultaneously with-holding it from a separate group. Control in experimental research refers to controlling as many variables as possible in terms of the study context and participants and requires the inclusion of a control group in the design (Parahoo 1997, Polit et al. 2001). The control group do not receive the new treatment intervention and their response to ‘standard’ treatment is used as a benchmark for evaluating the response of the experimental or intervention group. The use of a control group in conjunction with an explicit and clearly defined protocol that directs the study provides assurance of high levels of consistency in implementing the independent variable and data collection.
The third essential component for an experimental research design is randomisation or more specifically, random allocation. This means that each participant has an equal chance of being assigned to the intervention or control group, thereby eliminating bias. Friedman et al. (1998) suggest that the essential feature of random allocation of participants is that it greatly increases the chances
of producing comparable groups, as confounding variables should be equally distributed, and it guarantees the validity of statistical tests of significance.
4.5.1.4Quasi-experimental Research
Before discussing the main experimental research designs, it is helpful to briefly refer to quasi-experimental research. Quasi-experimental research designs are similar to experimental research because they include manipulation of an independent variable, i.e. the introduction of a new treatment of therapeutic intervention (Knapp 1998, Polit et al. 2001). Examples of this type of research include the non-equivalent control group and time-series designs. The non- equivalent control group pre and post design includes the use of a control group but not random allocation. The time-series design has neither a control group nor random allocation of participants. The advantage of quasi-experimental research designs is that they are practical in situations where randomisation is difficult. However, the absence of a control group or randomisation procedures in these types of studies greatly limits the researcher’s ability to make cause-and- effect inferences. For this reason, quasi-experimental research is not appropriate for this study because it will not facilitate answering the research questions posed or test the null hypothesis.
4.5.2 Experimental Research Designs
There are a number of main experimental research designs. The most basic of these designs are the pre-test/post-test design and the post-test. Knapp (1998) suggests that although including a pre-test in the study design incurs additional costs and adds complexity to data analysis, its advantage lies in that comparison may be made between the groups prior to the intervention being administered. It allows the identification of differences between the groups at the outset that can be factored into the analysis. A more complex experimental research approach is the factorial design in which two or more variables are manipulated simultaneously. Participants in studies using the factorial design are randomly
assigned to a combination of treatments; however, the participants exposed to one variable may not be the same group that are exposed to the other variables being manipulated in the study. This is known as between-subjects design (Polit et al. 2001).
Another experimental approach to research is the repeated-measures design. This design uses a within-subjects design, which means that the same participants are exposed to more than one treatment. This design has the advantage of allowing equivalence among participants who are exposed to different treatments, but a disadvantage of this design is the carryover effect. This occurs when the first treatment a participant receives influences their response to the second treatment. Polit et al. (2001) propose that the order of presentation of treatments also needs to be randomised when using this design, thereby distributing equally any possible carryover effects.
Perhaps the best known experimental research design in health care is the randomised controlled trial. In medical research this is known as the clinical trial and it is used to test the effect and value of new treatments, procedures or technology (Friedman et al. 1998). This is a prospective design that includes random allocation of participants, large sample sizes, and single or multiple research sites. Clinical trials generally include a pre-test/post-test design, which means they are conducted over a period of time and one key component of this design is that it includes a control group. This experimental research design was regarded as the most appropriate for this study because it would be able to answer research question 1, meet the aims of the study related to this question, and also allow the null hypothesis to be tested, which descriptive or correlational research would not do. The randomised controlled trial design with the use of psychometric tools not only allows any potential psychological effect of ‘Open Window’ to be identified but also, the size of the effect over time to be measured.
4.5.3 Qualitative Research
In contrast to quantitative research designs, qualitative research designs reject positivism and advocate interpretive and constructivist approaches to research. Many qualitative studies are designed as phenomenological, grounded theory or ethnographic. These approaches to research are based on the belief that there are many different realities and that knowledge cannot be decontextualised or objectified. However, the qualitative component of this study was not based in a particular epistemology. It was based on a descriptive design which Sandelowski (2000b, p337) describes as having the purpose of obtaining ‘straight and largely unadorned (minimally theorised or otherwise transformed or spun) answers to questions of specific relevance’ to the researcher. The purpose of using this design was to obtain a summary of patients’ experiences of ‘Open Window’ and their experience of having a stem cell or bone marrow transplant.
This study was not concerned with using the qualitative approach as its primary research design, as the main purpose of the study was to test the psychological effect of an art intervention. It was clear that the randomised controlled trial was the only possible design that could result in a rigorous study. However, by using a mixed methods research design, the study achieves its other aims of exploring patients’ views on ‘Open Window’ and how it influenced their experience of having a stem cell transplant. Friedman et al. (1998, 2) define a clinical trial as “a prospective study comparing the effect and value of intervention(s) against a control in human beings”. In this study the use of psychometric tools elicited the