Research is from the French word “research” which literally means to investigate thoroughly.
It is a process of systematic enquiry into a particular subject (phenomenon) which intends to create new knowledge and is governed by scientific principles (Cormack 1996). The department of health (DOH) defines research as: “the attempt to derive generalised new knowledge by addressing clearly defined questions with systematic and rigorous methods” (DOH 2005).
The Nursing and Midwifery Council (NMC 2008) clearly states that nurses must deliver care based on the best available evidence or best practice.
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Nursing research can provide a hugely exciting and challenging facet to the concept that is nursing. Being the largest workforce within the National Health Service (NHS), they are the professionals with the most direct contact with patients it stands to reason that this workforce should have robust evidence to support their practice interventions (Parahoo2006).
Patients can be asked to make decisions when they are emotionally fragile and thrust into an often unfamiliar world of doctors, nurses, hospital environments where the language used can seem unfamiliar. Working in the field of breast cancer can provide many opportunities to explore the experiences of women as they strive to make decisions about their physical and psychosocial wellbeing.
Making a decision to undergo a breast reconstruction following mastectomy due to breast cancer can be harrowing and efforts must be made to ensure healthcare providers afford the best opportunities that enable women understand this process.
A literature search using databases Medline, [email protected], British Nursing Index, Embase, CINAHL and PsycINFO was conducted to review previous research undertaken to determine influencing factors on decision making. The terms breast cancer, breast reconstruction, decision making, patient satisfaction and quality of life, Breast Care Nurse and Breast Clinical, Nurse Specialist were used.
Results were limited to the English language, relevant to humans.
A literature review should provide a rationale for the study, show why the study is required and how it will add to the body of knowledge already known about the phenomenon. (Parahoo 2006, Cormack1996).
Adjusting to a diagnosis and the treatment options of breast cancer is a complex process (Brennan 2001). The process is influenced by numerous factors (Wenzel, Fairclough, Brady, Cella, Garret, Klushman 1999) and altered body image is one of the most significant (DeFrank, Mehta, Stein, Baker 2007). In the last few years there has been increasing attention paid to the role, perceived body image plays in patient’s, diagnosed with breast cancer has on this adjustment. Pikler and Winterowed (2003) prove that patients who essentially felt good about their body were more firm in their belief in their ability to cope with the disease and the subsequent treatments.
Women’s emotional and psychosocial functioning may be significantly affected when
Coping with a diagnosis of breast cancer, which may impair their decision making ability. Reaby (1999) supports this view suggesting “their ability to make an informed decision about breast restoration is greatly reduced because of the emotional and physiological conditions created by their health crisis”. Literature supports the process of breast reconstruction following mastectomy as increasing long term health and wellbeing (Streu, Chung & Alderman 2009). This assumption is refuted by Harcourt & Rumsey (2001) who suggest this belief is not supported by evidence and further inquiry is required.
However whilst there is much literature available highlighting the effects of timing of breast reconstruction, type of reconstruction (autologous or implant) and of the impact other treatment modalities may have on a technical success there is little robust evidence to support one method in favour of another in terms of quality of life or body image (Potter & Winters 2008) . Guidelines have been produced by The Association of Breast Surgery, The British Association of Plastic, reconstructive and Anaesthetic Surgeons and the Training Interface Group which recognised that it is difficult to conduct controlled trials in this cohort and hopes the guidance will provide standards for safe breast reconstruction following mastectomy for breast cancer (Lee & Bishop 2009). There remains a lack of consensus on when to perform the procedure, what procedure should be performed and which patients are/are not suitable to undergo the procedure. Without consensus guidance from professionals cannot be anything other than subjective and ultimately can lead to decisions which are not fully informed (Lee, Dominik, Levin, Barry,Cosenza, O’Connor, Mulley & Sepucha 2010). The authors of this study report on the necessity of tools to assess the quality of the patient’s decision making which will reflect shared decision making.
The reviewed literature highlights various findings on the decisions women make regarding breast reconstruction. Chevray (2008) suggests that women are not adequately informed about the availability of this option. Older age and the less educated are less likely to opt for breast reconstruction according to (Greenberg, Schneider, Ko, Lipitz, Mallin, Epstein, Weeks & Kahn 2007). Theses particular studies are American where the healthcare system is different from that in theUnited Kingdom. They were quantitative, retrospectively analysed from existing databases and neither study reflected the women’s personal experiences of the process they found themselves having to make decisions within. Limitations to the study such as women’s access to specialist centres for breast reconstruction and financial cost, if not adequately covered by insurance, which may have precluded them from breast reconstruction are not addressed in the findings.
Falbijork, Karlsson, Salander, Rasussen (2010) concluded similar results with regard to age but did not take into consideration the meaning of mastectomy or body image to women although recognise these variables should be considered. They conclude that age is of paramount importance for further studies to enable understanding women’s choices.
Stacey, Spring, Breslin, Rao & Gutowski (2008) reinforced the multifactorial nature of decision making regarding breast reconstruction following mastectomy for breast cancer. They evaluated the attitudes of circa 100 general surgeons to breast reconstruction; 40% did not refer all patients for breast reconstruction citing reasons which included refusal by patient, need for radiation treatment, may delay adjuvant oncological treatment, patient issues or the lack of available plastic surgeons. One of the conclusions they reached highlighted the need for education of the referring surgeon and patient about options and indications for reconstructive surgery.
A related study by Reefy, Patani, Burgoyne Osman & Mokbel (2010) reviewed 127 patients who underwent immediate breast reconstruction following skin sparing mastectomy for early breast cancer. The patients were followed up for 36 months the procedure was associated with low morbidity and deemed oncologically safe for T, T1 & T2 tumours without extensive skin involvement. It stated that 85% of patients who required either prior or post mastectomy radiation treatment underwent capsulotomy for significant capsule formation. In keeping with Stacey et al (2008) focus should be on the education of surgeons and patients on the effective, safest management of breast reconstruction to guide informed decision making.
Lee, Belkora, Chang, Moy Patridge & Sepucha (2011) evaluated patient decision making about breast reconstruction (BR) and patient involvement in the process and concluded that patients were not well informed about BR and as such would benefit from interventions which supported their decision making. Winters, Benson & Pusic (2010) systematically reviewed 1012 abstracts of which 34 papers included Health Related Quality of Life (HRQoL) outcomes in breast reconstruction. Their findings showed that robust scientific data is sparse in methodology on HRQoL studies and increasingly patients and healthcare providers seek meaningful information to guide decision making. They concur with Lee & Bishop (2009) that randomised clinical trials are required to establish guidelines to inform decision making.
Another study carried out by Jeevan, Cromwell, Brown Traveller Pereira, Caddy, Sheppard & Van Der Mullen (2010) identified that of 44, 837 women who underwent mastectomy for breast cancer, 7375 underwent immediate reconstruction. (IR) They showed that the uptake rate for IR was highest in the younger age group (<50 years of age) and lowest in those over 70 years, a finding which concurs with Greenberg et al (2007) & Falbijork et al (2010). Jeevan et al focused on the regional variations of IR uptake and showed that women from more deprived areas were less likely to undergo IR as were non white women.
This is direct contrast to Osborn, Hodin, Drew, Fielder, Vaughn-Williams & Sweetland (2005) who found no association between deprivation and ethnicity and treatment choice but did find older age as an indicator of being less likely to undergo breast reconstruction.
Qualitative studies have attempted to establish patterns in women decision making when considering surgical options. Reaby (1998) developed a decision making model hope to enhance decision making capability of the women. It seems to be designed to essentially slow down the women’s decision making to allow time for her to explore her understanding of the options that should have been presented to her, to alert that there may be options available and to explore the impact such decision making may be having on her and her family. The study Reaby conducted suggested that the specialist nurse was in a valuable position to undertake the role of providing physiological and psychological support, acting as their advocate thus enhancing the decision making process.
Harcourt & Rumsey (2001) conducted a literature review identified the need for further research into the experiences of women deciding for or against reconstruction and the process by which they decide. They highlight that studies in their review did not take cognisance of the nurse specialist. They identified the drawback of randomised controlled trials citing them as inappropriate in this area, and suggest that research in this area should be prospective and from the time of diagnosis. This is an identified gap this study seeks to address.
Three years later Harcourt & Rumsey (2004) followed up their previous research showing that individually, women need appropriate information, time to make decisions and ongoing emotional support. Limitations to the study were that interviews were conducted post decision which left the gathered information subject to recall and there were unidentified difficulties with the study being prospective.
Lally (2009) study involving 18 women newly diagnosed with breast cancer who were to make decisions regarding surgical options, showed that women felt supported by specialist nurses and the surgeon in their decision making. This has implications for clinical practice providing evidence of the importance of the availability of these healthcare professionals to this patient cohort.
Wolf (2004a&b) identified the importance of the role of the breast clinical nurse specialist in facilitating the process of how patients receive information. Information giving has been associated with increased autonomy, moving away from a paternalistic approach and considered to help patients cope with cancer.
Qualitative research seeks to lend understanding of how people think individually and as part of a group. The approach is one that is interactive, holistic and inductive, data collection is flexible and reflexive (Parahoo 2006). This results in data collection and analysis that has evolved as the researcher gains insight and new questions emerge throughout the process (Pollit & Beck 2004).
The following study design describes the approach to enquiry, the methods and methodology to be used to collect data, when, where and from whom the data will be collected and how the data will be analysed.
Methods and Methodology
In quantitative research comes from a philosophical paradigm which suggeststhat human phenomena can be subject to objective study (Parhaoo 2006). Historically quantitative researchers believed that human behaviour could be predicted, a belief based on the positivist approach to natural science that the world works according to fixed laws of cause and effect or causality by testing hypothesis and theories (Muijs 2011). This approach strives for objectivity and to avoid bias advocates distance between researcher and subject (Holloway & Wheeler 2002).
Quantitative research has been used by nurses dating back to the Crimean war (1853-1856) and can produce robust scientific data which is essential for evidence based practice (Parahoo 2006). However it has been criticised for being narrow and inflexible, of focussing on a small part of the human experience where nursing concerns itself with a holistic approach (Pollit & Beck2004).
In comparison qualitative research is flexible and the relationship between researcher and participant less formal. Phenomenology, grounded theory and ethnography are the main research traditions which underpin the philosophical approach to qualitative research (Polit & Hungler 1997). Such research traditions explore the subjective nature of the human experience (Magilvy2003) and aim to collect data in naturalistic environments ensuring a holistic approach to data gathering which requires the researcher to be intensely involved in the fieldwork as “a full co-participant”(Polit & Beck 2008). Each of the disciplines focuses on the experience of human beings and their interpretation of the experience (Holloway& Wheeler 2002). The approaches demand careful collection and analysis of rich in-depth data to provide a comprehensive understanding of peoples thinking and behaviour which can improve efficiency and predict outcomes in the healthcare setting (Parahoo 2006).
Qualitative research has been criticised as anecdotal, for producing findings that are neither scientific nor generalisable and, due to the intense involvement of the researcher, objectivity is lost (Parahoo2006). To reduce researcher bias or maintain objectivity in data collection a process known as bracketing may be used which enables the setting aside any personal beliefs, prior knowledge or expectations the researcher has regarding the study.
Qualitative and quantitative research methods are appropriate for nursing research and both create or increase knowledge that may explain or describe the phenomenon being studied (Harper & Hartman1997).
The intent of this study is to explore and lend understanding about how women decide to uptake breast reconstruction or not following mastectomy for breast cancer therefore a qualitative approach will fit as it seeks to explore the experiences of decision making.
Sampling is the process of selecting a portion of the population from the total population of the subject of the enquiry; a sample is a subset of that population (Pollit & Beck 2004). Sampling allows cost effective research as resources such as time and funds are likely to be limited and can provide robust information.
There are two basic types of sample; probability and non-probability. A probability sample is randomly selected in contrast a non-probability sample is chosen to provide the sought data (Parahoo 2006). The selection of the sample should be robust enough to identify and use the participants who can supply the information to inform the study (Polit & Hungler 1997).Qualitative researchers aim to gather data which is rich and in-depth; this is the underlying principle which guides the sampling technique.
For the purpose of this study the researcher intends to recruit 8-10 participants using purposeful sampling technique. Polit and Beck (2008) describe this as using the researcher’s knowledge about the sample population to “hand pick” potential participants who will most benefit the study. These individuals will be sampled as those most likely to be able to provide information on decision to undergo reconstruction following mastectomy or not.
Sample size does not determine importance of the study or the quality of the data, in qualitative research too large a sample size risks loss of depth and meaning and may reduce the richness of the data (Holloway & Wheeler 2002).Some texts recommend between six and eight participants (Holloway & Wheeler 2002) others suggest size should be based on informational needs (Polit & Beck 2004). If saturation occurs before this number is achieved then recruitment will be limited to the saturation point. Saturation refers to the point when no further meaningful data is obtained and as such the number of participants can be led by the fullness of the data collected (Wood & Ross-Kerr 2006).
To address the research question, the researcher initially considered recruiting female patients requiring mastectomy to the study at the time of diagnosis when discussion regarding breast reconstruction cancer would occur. However, following discussion with the course leader and a period of reflection, it was decided that this was a vulnerable cohort and it would not be ethical to approach them at a time when they were trying to process information regarding a cancer diagnosis and subsequent treatments.
A decision was taken to approach the women 3-6 months post diagnosis when their rationale for their decision was still clear to them and breast cancer support
mechanisms were in place.
The intention is to approach the consultants who are responsible for breast cancer patients in a specific regional area for permission to recruit the patients. Being part of the multidisciplinary team, as a breast clinical nurse specialist, involved in managing the care of these women, the researcher is known to the consultants and does not anticipate any objection to this.
Individual participants will be approached by the researcher and given verbal and written information about the study, a suitable length of time to decide to take part or not will be agreed. The individual will be reassured that their decision will be respected and, regardless of outcome, they will continue to receive care without bias.
The researcher may be the healthcare professional designated to fulfil a particular aspect of care of some of the sample group. It is anticipated that this would not bias any data collection as the same level of professional intervention is given to all patients undertaking this decision making process. Goodman & Moule (2009) highlight the responsibility of the nurse researcher to inform the participant that they are acting as a researcher. Bracketing can be utilised to suspend any researcher beliefs or preconceptions. This theory will be tested in the pilot study and should any bias be revealed then the researcher will ensure the standard care of the study cohort is supplied by an independent practioner.
Potential participants will be recruited at a planned follow up appointment where patients attend for review of their treatment. This negates the requirement of an extra appointment for participants.
Research supports the development of nursing knowledge and as individuals and professionals nurses undertaking research must consider the ethical issues that can arise (Smith & Hunt 1997).
When participants in research are vulnerable, as in the health care system, their rights must be protected (Wood & Ross-Kerr 2006). The Royal College of Nursing Research Society Ethics Guidance Group (2009) highlight that nurses can have a variety of roles in research including carrying out their own projects, that it is important the nurse understands the important issues in research practice and it is their role to protect the participant and their rights. Beauchamp & Childress (1983) illustrate the concept of biomedical standards as four principles; respect for Autonomy, Beneficence, Nonmaleficence and Justice which underpin healthcare ethics.
Without understandable information an individual is not able to make an autonomous decision to participate in research or not; they are therefore unable to give informed consent. Berendt, Golz, Bertz & Wunsch (2011) conducted a qualitative study asking what patients understood about trial participation, specifically assessing their understanding of informed consent and discovered that patients’ understanding was less than anticipated and the patients’ identified needs including “ clear informed consent consultations”.
The notion of informed consent encompasses; the right to be informed, consent to be given voluntarily and competence of the participant (Tschudin 2003).
The participants anonymity and confidentiality must be protected therefore any information provided by interviewees will not identify them nor will it be accessible to others. For the purpose of the study suitable storage for data pertaining to the research will be sought.
Prior to seeking approval for the study from the local National Health Service (NHS) research ethics committee and the local research and development department, the researcher will seek guidance from the appointed academic supervisor.
To ensure informed consent participant information sheets about the study purpose which will include any benefits and risks, dissemination of results, assurance of participant anonymity and consent forms will be provided. Participants will be advised they are free to withdraw from the study at ant time without penalty and asked to sign a consent form a copy of which will be given to the participant and one retained by the researcher. Consent forms and information sheets will be utilised using guidance from the National Research Ethics Service website www.nres.npsa.nhs.uk/.
Participants may recall experiences that cause emotional distress and as their needs are greater than those of the study the process would be suspended or discontinued ( Thompson, Melia & Boyd 2000).
The intention is to generate data using in-depth unstructured interviews which enable the informant unlimited opportunity to convey their perception of events. This is an intentional approach to discovering the participants lived experience of the phenomenon and the interviewers’ ability to listen and convey respect and importance of the experience is crucial (Oman, Krugman & Fink 2003).
Unstructured interviews are purposeful conversations which enable rich but often unquantifiable information about the phenomenon (Smith & Hunt 1997) the conversations are interactive and usually begin with general questions to enable truly unstructured interview, for example “What happened when you first learned you would need to undergo mastectomy?” (Polit & Beck 2004). Interviews can last from thirty minutes to two hours and interviewer/interviewee interaction may vary therefore in qualitative interviews flexibility of the researcher is key to obtaining useful data (Parahoo 2006).
Structuring data generated from unstructured interviews is known as content analysis and themes will be looked for in the data and divided into categories. The categories that will be developed are dependent on the researcher and can be further categorised into frequency tables to indicate the frequency of the response (Wood & Ross-Kerr 2006).
The qualitative interviewer is the tool of data collection as it will be she who analysis data in her mind during interviews thereafter transcribing and presenting the data in a way that can be easily understood (Parahoo 2006).
Qualitative researchers recognise the subjective nature of the interview process and seek to ensure rigor by incorporating reflexivity and validation of data by the interviewee, reflexivity enables the respondent to report on the accurateness of the transcribed interview and can provide opportunity for clarification (Parahoo 2006). Others utilise four criteria to establish trustworthiness; credibility, dependability, confirmability and transferability (Polit & Hungler 1997). Credibility refers to trust in the data enhanced by giving sufficient time to gather data to give in-depth understanding of the study cohort. Member checking is regarded as an important technique for establishing the credibility of qualitative data and involves feedback of the data and researchers findings and recording the respondent’s reactions. Peer debriefing relates to the exposure of the researcher to others who are experienced in either qualitative inquiry or the studied subject who can review aspects of the inquiry. Dependability refers to the ability of the data to stand the test of time regardless of the conditions and is liked to confirmability. Confirmability is a measure of the objectivity of the data and as such the researcher should present an audit trail of the data, methods and decisions to an external auditor to check trustworthiness. This strategy may offer some protection to support trustworthiness but caution should be used; the unique nature of inquiry may not lend themselves well to different interpretations of data. Transferability requires the researcher to demonstrate the extent their findings can be applied to other contexts (Goodman & Moule 2009).
A pilot study is a trial of the research method on a small scale the purpose of which is to ensure the study design is feasible (Presly 1996, Polit & Beck2004).
A pilot study will be conducted using an unstructured interview as planned for the main study. This will enable a trial of the interview process, gauge length of time interviews may take and allow the researcher to familiarise herself with technical equipment (Lacey 2006).
Data collection & analysis
Data collection refers to the way information is collected, recorded and presented to address a research inquiry (Clamp, Gough & Land 2004).High quality data increases the value of the research and the aim of the qualitative data analysis in this study is to structure the data into meaningful units using thematic analysis. This stepwise approach begins with the researcher identifying themes in the data, thereafter categorising the themes; this may be a natural occurrence or the researcher must decide the category. The final step is to structure the data and this can be achieved by developing a frequency table which serves to identify the frequency of every category, the response rate and number of participants who gave the same response (Brink & Wood 2001).
The researcher intends to audio tape participants during unstructured interviews, using field notes to complement data collection. Field notes can facilitate deeper understanding of the data as it enables conveyance intangible elements such as body language and feelings. They are also useful in the event of failure of audio equipment.
Surgery for breast cancer is an emotional experience and mastectomy can be particularly harrowing as women face disfiguring surgery and a potentially life threatening disease. Making decisions at a difficult time may render potential study participants emotionally unavailable which may impact on recruitment to the study and delay the planned recruitment period. Should this situation evolve the intended cohort will be extended to include those women who underwent mastectomy more than six months previously but no longer that eight months to capture the freshness of their experience.
The study forms part of a Masters programme which allows circa ten months for the completion of the study therefore any delay in the timeline could be crucial. As such ethical approval will be sought early to facilitate a prompt beginning to data collection.
Details of the plan of work and timescales show the expected duration of each stage of the study and endeavour to show the feasibility of the study (Cormack1996).
A Timetable for the proposed study has been prepared (appendix 2) and will be adhered to. It demonstrates the beginning and expected conclusion of the study activities and shows where they run simultaneously.
The budget estimation for this enquiry is as follows:
Researcher time Agreed by local management / colleagues
Transcribers’ time (agreed)? 40.00
Postal costs ?
The reviewed literature reveals a variety of reasons why breast reconstructive surgery is undertaken by some women following mastectomy for breast cancer. These include age, socio economic status, ethnicity, availability of surgeon, potential effects of radiotherapy id required amongst others.
It has been highlighted that decision making ability may be impaired due to emotional conditions caused by a health crisis. All of the research identified the need for further research. There was very limited inquiry into how the women made their choices and none of it captured the women’s experiences of making the decision.
This study provides an opportunity to discover how women feel about making decisions. It is anticipated such a study could enhance how healthcare providers attend to the needs of women who must make a decision to undergo breast reconstruction following mastectomy due to breast cancer.
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