Nurse Researcher

Methodological and ethical challenges in investigating the safety of medication administration

Cite this article as: Mansour M (2011) Methodological and ethical challenges in investigating the safety of medication administration. Nurse Researcher. 18, 4, 28-32. Received July 6 2010; accepted December 1 2010
Correspondence to Mansour Mansour Email mansor.mansour@ anglia.ac.uk Mansour Mansour RN, PhD is a lecturer at the Department of Acute Care, Faculty of Health and Social Care, Anglia Ruskin University, Chelmsford, UK

Abstract
Aim The aim of this article is to highlight some of the methodological and ethical challenges that the researcher faced when conducting a study of the safety of medication administration. Background Investigating a sensitive topic, such as the safety of medication administration, can be methodologically demanding, time-consuming and ethically challenging. Moreover, it can be particularly difficult to balance methodological with ethical and legal challenges. This article presents the considerations involved in the sampling, recruitment and ethical issues related to participants involvement in a medication safety study. Data sources The article draws on the methodological and ethical approaches related to one qualitative study that investigated the nurses views of the organisational contributions toward the safety of medication administration in adult critical care. The study was completed in 2009. Discussion The study used a questionnaire to recruit the participants and this gave the researcher the advantage of being able to select critical care nurses from particular backgrounds, enriching the views and perspectives relating to the topic under investigation. Approaching the participants for expert opinions, rather than error-makers, helped to established early rapport with the participants. Research rigour and data trustworthiness were demonstrated by several operational techniques, including providing a detailed account and justification for the research process. Conclusion Research into patient safety may have particular methodological and ethical challenges and therefore needs an appropriate research approach to balance practicality, the participants integrity and research rigour. Implications for practice and research It is anticipated that this approach will provide an insight into some challenges that may arise in conducting patient safety research, providing a useful guide for others to consider in their future research. Keywords Medication administration, safety, critical care, nurses the nurses perspectives on how organisational issues can enhance or jeopardise the safe administration of medication in adult critical care. The study presented many methodological and ethical challenges, including how to approach the participants and how to promote the sense of security that would enable the participants to open up and give their expert accounts. This article will shed light on some challenges that I confronted in my research and the strategies I used to manage these challenges.
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Introduction
Research into patient safety has become increasingly prevalent worldwide (World Health Organization 2009). There has also been a call for the careful consideration of the methodological approaches used in research into patient safety (Department of Health (DH) 2001). This paper draws on a study conducted in 2007 that investigated critical care nurses views about the safety of medication administration. In particular, the study investigated 28 July 2011 | Volume 18 | Number 4

Patient safety
Planning
Patient safety is a sensitive topic so research into this area requires careful consideration during its planning and implementation. For example, it often involves investigating the causes of unsafe practice, which can involve discussing some negative aspects of particular work environments, organisations or even the attitudes and behaviours of individuals. For these reasons, the participants may not feel secure in expressing negative views, particularly when full confidentiality cannot be promised (Holloway and Wheeler 2010). Moreover, some conflict may arise between maintaining the confidentially of the participants and maintaining a duty of care (Shaughnessy et al 2007). Such situations are likely to present serious recruitment challenges for the researcher, particularly when recruiting healthcare professionals, whose professional codes of practice oblige them to report any misconduct revealed during research. My study used qualitative semi-structured interviews. This interview method provides an opportunity to explore how participants explain their experiences and practices the objects of the research (Murphy and Dingwall 2003). It gives the researcher the flexibility to exercise some degree of control over the interview as well as in discussing the topic being investigated, which makes it a suitable method for systematically collecting the necessary information (Patton 2002). In my study, most of the interviews lasted for 45-60 minutes and covered the two main issues pertaining to the safety of medication administration: what promotes safe medication administration; and what can cause problems with this in adult critical care. Collectively, the analysis of the interviews focused on understanding the effects of organisations on the safety of medication administration. New themes that emerged during the interviews were subsequently addressed. The remainder of this article will focus on the following methodological issues: Sampling strategy. Sample size. The recruitment and collection of demographic information. Ethical considerations. Data analysis. Although I will consider these separately, there is much overlap between them. rich source of data (Patton 2002). To pursue this goal, I used two stages of sampling in my study. In the first stage, I used purposive sampling and sought out nurses from pre-specified backgrounds. I did this because I needed to access the views of the participants who were most knowledgeable about medication administration in adult critical care. While the administration of medication is a multidisciplinary practice that requires the active engagement of a range of healthcare professionals, including doctors and pharmacists, nurses are crucial in carrying out this function (Armitage et al 2004). In addition, Gibson (2001) suggested that nurses views relating to this issue had often been overlooked. Therefore, I decided to include only nurses in the study sample. The nurses I chose were likely to demonstrate different experiences concerning the safety of medication administration, depending on factors such as their managerial and clinical roles. Norwood (2000) described maximum variation sampling, in which informants are selected because they represent a wide range of variations, as one strategy for purposive sampling. Although the participants were nurses by background, I chose nurses from different grades and critical care settings and with different levels of experience. This helped to obtain a wide range of views and perspectives. To achieve this objective, I selected two campuses from one NHS hospital trust and identified in each campus those clinical wards that deliver level two adult critical care (high dependency units) and level three adult critical care (intensive care units), since hospitals that deliver these levels of care have been in the lead in providing critical care (DH 2000). Each campus had at least four wards that delivered these levels of care, with approximately 250 qualified nurses working in those settings in both campuses combined. Finally, I selected staff nurses working in those settings who were registered with the Nursing and Midwifery Council (NMC) and came from three professional grades: band 5, band 6, and band 7 and above. In case there were not enough participants recruited during the first sampling stage, the plan was to use snowball sampling in a second recruitment stage. Snowball sampling is: The process of asking the studys participants to identify other potential subjects who also meet the eligibility criteria (Norwood 2000). Many of the potential participants in this study were working in the same critical care settings together and it was inevitable that many of them would have day-to-day contact with each other. It appeared feasible that any nurse who participated in the study would be
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Sampling strategy
Qualitative research sampling tries to identify key individuals, events or settings that are able to address the research questions and provide a
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able to invite colleagues to join it as well. So the second backup stage of recruitment would involve asking those participants who had already agreed to be interviewed in the first sampling stage to invite colleagues who met the inclusion criteria to participate in the study as well. Figure 1 Recruitment plan for the participants Ethical and R&D approvals obtained

Sample size
Although qualitative research usually relies on studying a small number of participants in depth, the sample size has to be large enough to answer the qualitative research question (Sandelowski 1995). Mason (2004) acknowledged that it may not be possible to specify exactly the number of participants required at the start of the study and that deciding the sample size is a dynamic process that starts at the beginning of the study and continues during the period of emerging information to achieve data saturation. The choice of sample size in my study was flexible from the start. It was partly guided by my desire to cover a certain degree of demographic variations among the selected participants, but also by my need to achieve data saturation. I only stopped recruiting participants when there were enough to fill the sampling framework and when I had ascertained that no additional themes were emerging from the interviews. The final sample included 33 adult critical care nurses from various grades: 11 ward managers and clinical governance nurses (band 7 and above), 11 senior nurses (band 6), and 11 staff nurses and newly qualified nurses (band 5); female nurses predominated (n=23). I put in place some contingency steps in case the number of participants who responded was more or less than the number of the participants needed for the study as it progressed to achieve the data saturation. I sought and obtained full ethical approval from the local research ethics committee and the trust research and development department in March 2007.

First recruitment stage

Nurses with band 7 and above are sent letters directly to their wards

Nurses with band 5 and 6 are handed letters through the school of nursing

Nurses from all bands who are willing to participate will complete and return demographic questionnaires

Participants respond from various backgrounds

A sample of participants will be selected and interviewed, but data saturation is not yet achieved, more new themes are still emerging

A sample of participants will be selected and interviewed until the data saturation is achieved from different backgrounds

More nurses are still needed

Letters will be sent to the remaining participants to thank them and inform them that they are no longer needed

Second recruitment stage Those who are interviewed will be asked to invite a colleague who meets the inclusion criteria to participate in the interview

Recruitment and collection of demographic information

To recruit nurses from diverse backgrounds, I distributed the recruitment questionnaire to the target population (Procter and Allen 2006). The information provided by the questionnaires helped to single out the participants for the study according to my predefined selection criteria. I then sent recruitment packs to the ward managers and clinical governance nurses who usually hold band 7 and above in the wards I was investigating. Each recruitment pack included an invitation letter, a short demographic questionnaire, a participant 30 July 2011 | Volume 18 | Number 4

information sheet and a stamped addressed envelope. Those who were willing to participate in the study were asked to complete and return the questionnaire using the enclosed envelopes. Band 5 and 6 nurses were approached through the School of Nursing at East Midlands University. Adult critical care nurses who were working in the selected hospital campuses could attend up to nine modules of the post-registration continuing professional development courses run by the School of Nursing. I attended one lecture in each module, explained the aims and objectives of the study, and gave recruitment packs to those nurses who were working in the adult critical care wards in the chosen
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Patient safety
campuses. Those who were willing to participate in the study were asked to complete and return the questionnaire in the enclosed envelopes. I chose not to approach the ward managers when recruiting the band 5 and 6 nurses, since it had been suggested that directly approaching more junior nurses would make them feel more secure in expressing their views, particularly when discussing sensitive topics (Taxis 2001). I recruited 14 participants during this first recruitment stage. All but one of the participants from the band 7 and above nurses invited for interviews (n=10) indicated their willingness to participate in the study. However, only four out of 36 recruitment questionnaires given to band 5 and band 6 nurses were returned. I therefore re-attended several courses and reminded the nurses to consider participating in the study by sending back their completed questionnaires. As new themes were still emerging from the participants interviews, I decided I needed more participants. Previous studies have shown that if participants do not respond within three weeks of being invited, they are unlikely to respond at all (Al-Nawafleh 2008). Four weeks after I had given out the last recruitment package, I had received no further completed demographic questionnaires so I decided to proceed to the second recruitment stage. I asked those nurses who had already been recruited and interviewed to pass the recruitment packs to those of their colleagues who met the inclusion criteria and came from the backgrounds that were still outstanding. During this second stage, I recruited a further 19 participants. participants and encourage them to participate in the study by eliminating any prior assumptions about and stigmatisation of them, and promoting what Murphy and Dingwall (2003) called trustfulness and openness with them. The participant information sheet explained the purpose of the study and the likely risks and benefits for the participants and me. It also stressed the participants right to withdraw from the study at any time and without giving any reason. Before the start of each interview, each participant completed and signed the study consent form. The participant information sheet stated clearly that the names of the nurses interviewed would remain confidential and that their views would always be anonymised. However, it also stated that because I come from a nursing background, I am obliged to abide by the Nursing and Midwifery Council code of professional conduct (2010) and report any professional misconduct to the NMC.

Data analysis
I digitally recorded all but one of the interviews. I transcribed verbatim all of the interviews, which helped me to immerse myself in the data and consequently sharpened the data analysis. Following transcription, I uploaded the data to NVivo to assist in data analysis. I used thematic analysis, in which the transcripts were developed into a coding scheme, and the constant comparative method to generate emergent themes using a form of charting that involves rearranging the data according to thematic content, either case-by-case or theme by theme (Ritchie and Spencer 1994). The analysis also involved drawing relationships between the emerging themes.

Ethical considerations
Reasonable care must be taken to avoid any harm to participants (Holloway and Wheeler 2002). Previous studies have demonstrated that most research into medication safety has focused on what can jeopardise safe medication use, rather than what can enhance its safety (Dean et al 2002, Beso et al 2005). In doing so, such research has first identified the error makers, then attempted to investigate their views and behaviours. However, this approach projects a prejudiced assumption onto the participants so would be likely to create an unsafe and threatening atmosphere for them, which aside from anything else would impair their ability to be open and frank (Armitage et al 2004). For this reason, the participants information sheet explained that the interview would be a general discussion about the nurses expert views on safe medication administration. I anticipated that this approach would create a safe relationship with the
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Research rigour
To establish trustworthiness in qualitative research, Guba and Lincoln (1989) appealed to the criteria of credibility, transferability and dependability. The purposeful sampling used in this study contributed to the credibility of the research. I recruited the study participants because they were likely to share their understandings of the phenomena under investigation (Tuckett 2005). The constant comparison of the data that emerged from the participants interviews also enhanced the credibility of the research (Guba and Lincoln 1989). Both my academic supervisors confirmed that their interpretations of the participants quotes included in the data analysis were consistent with my interpretations. Transferability is concerned with the conceptual generalisation of findings (Guba and Lincoln
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1994). I endeavoured to produce information that can be shared and applied beyond the study settings. The themes that emerged can be related to other adult critical care settings, so there is a conceptual generalisability in that any participants experiences if well described, represent a slice from the life world (Denzin 1983). Moreover, there seems to be an agreement among the qualitative research community that it is the reader, rather than researcher, who carries the burden of claimed transferability of the research data (Guba and Lincoln 1989, Wolcott 1994). Therefore, it is up to the reader to evaluate this context and spot any similarities with other cultural contexts, in an effort to share and apply the findings beyond the study settings. The dependability of the research data is comparable to the consistency of the qualitative research findings (Guba and Lincoln 1994). The reliability of the interview data obtained rests on the competency of my interviewing skills and will be influenced by any research bias (Guba and Lincoln 1989, Appleton 1995). While such bias cannot be completely neutralised, it can be minimised depending on the interview skills employed by the interviewer. For my study, I enhanced my interviewing skills by carrying out two pilot interviews before data collection commenced. Digitally recording the interviews furthered the reliability of the data obtained by minimising any systematic bias (Tuckett 2005). However, more than half of the studys participants were recruited using snowball sampling. One limitation of this approach is that it risks turning the selection of appropriate participants over to a third party (Norwood 2000). Some participants were recommended by their ward colleagues and this may have influenced their views on organisational contributions to the safe administration of medication. However, snowball sampling was only used as a second choice for recruitment, and I made regular efforts to enhance the number of self-nominating candidates by re-attending the courses in the School of Nursing and reminding the nurses to participate in the study.

Conclusion
This article aimed to address some methodological challenges related to one qualitative study of the organisational contributions to the safe administration of medication in adult critical care. It demonstrates one approach to preparing a robust recruitment plan with contingency steps for reaching potential participants that takes into account the ethical and methodological considerations. The value of using a recruitment questionnaire in accessing potential participants with a range of parameters was also highlighted. Several operational techniques were used to enhance the rigour of the data collection and analysis. I hope that the methodological approach described will provide more structured guidance for researchers who may consider using similar methodological approaches in future.

Online archive
For related information, visit our online archive of more than 6,000 articles and search using the keywords. This article has been subject to a double-blind review and checked using antiplagiarism software Acknowledgments The author would like to thank Veronica James and Alison Edgley from the School of Nursing, University of Nottingham for their contributions toward the work published in this article

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