Research Methodologies and Ethical Principles Underpinning Research

Essay to demonstrate an understanding of research methodologies and ethical principles underpinning research.

This essay uses the Scottish Intercollegiate Guidelines Network (SIGN, 2018) checklist to critically appraise the methodologies of two quantitative and two qualitative research articles on the management and treatment of pressure ulcers (PU’s). The four articles retrieved for this essay include the two qualitative research method conducted by Barakat-Johnson

et al.

(2019) in Australia, and Carlsson and Gunningberg (2017) in Sweden. While, the two quantitative methods were conducted by Charalambus

et al.

(2019) in Cyprus, and Kalowes, Messina and Li (2016) in America. In order to demonstrate an understanding of the qualitative and quantitative research methodologies, the studies will be critically appraised in four different sections. The first section of this essay will emphasise on the management of the PUs and its relevance to nursing practice. The second section will provide an overview of the four chosen journals, and this will include the method, design and their individual research findings. The section will further critique the studies, as well as their strength and limitations using the SIGN (2018) tools. In section three, the policy of research governance and the steps taken by the authors to address the ethical issues raised in the journals will be critically analysed. Finally, section four will critically evaluate the two methodological approach used, and the importance of using both qualitative and quantitative research in the nursing profession. Then, the essay will be concluded by summarising the key issues raised while appraising the four journals.  In-line with the Nursing and Midwifery Council (NMC, 2018) code, Confidentiality policy will appropriately be maintained within this essay by using pseudonyms for places and names as required.

As the four studies were conducted in different countries, the nurse’s cultures, values, beliefs about management and prevention of PUs may be different from the experience and knowledge of the nurses in the United Kingdom (UK). Therefore, one will be cautious while applying the findings to the healthcare settings in the UK as there may be differences in the PU treatment guidelines, protocols and policies. The International Council for Nurses (ICN) emphasis on the need for nurses to apply the evidence from clinical literatures which have an informed basis for their clinical decisions (ICN, 2012). Adoption of evidence-based practice (EBP) by the nurses is vital because they are directly involved in the management and treatment of PUs as part of a multidisciplinary team approach in various healthcare settings

(Lehane

et al.

, 2018)

. However, King Funds(2018) argues thatalthough the guidelines and research evidence are used in the management of PU’s in the UK, the quality of the treatment provided by individual nurses varies. As a result, there is a need to explore the attitude and knowledge of nurses on prevention and treatment, as well as the barriers which impact on the nurse’s management of PUs. National Institute for Health and Care Excellence (NICE, 2018) guideline emphasised on transparent treatment, quality improvement and outcome measurement. The guideline enables the nurses to improve healthcare and reduce inequalities in health treatment by effective adoption of evidence-based practice (EBP). Hence, the effective application of EBP in healthcare management is crucial in reducing avoidable PUs and promoting patient safety. This is important as research findings aids improvement of policies and practices in nursing, and research evidences help to reduce the rate and risk of PU development in patients and provides the necessary support needed for the treatment (

Lehane et al., 2018).

The qualitative study carried out by

Barrakat-Johnson

et al.

(2019)

explored the thoughts and experiences of hospital nurses in the management of PUs. A purposive sampling was used to recruit 20 nurses working the units with high records of pressure injuries across the local health district in Australia. The participants are the senior and junior nurses from specific units in four different hospitals, including orthopaedic, neuroscience, transplant, cardio-vascular, intensive care, rehabilitation, acute and medical aged care units as they have the highest recorded incidence of PUs compared to other units. A semi-structured interview was used to collect the data between May and September 2016. The interview lasted between 20-40 minutes in a private location chosen by the nurse participant. This is to ensure the participants are not known by other members of the clinical units. The interviews were audio-recorded and the data was thematically analysed. The study was piloted using five nurses which include both the senior and junior nurses in order to determine the feasibility of the planned research and to reduce the unethical collection of unused data (Harvey and Land, 2017).

The second qualitative research conducted by

Carlsson and Gunningberg (2017

) has two clearly stated objectives. The initial objective was to identify and describe different ways in which nurses understand unavoidable PUs in late palliative care. Then the second objective was to explore the expediency of the different levels of understanding the unavoidable PUs. The recruited participants were 8 nurses and 7 healthcare assistants (HCA) who work in various nursing homes and specialist palliative inpatient care units in Sweden. A purposeful sampling was also used f

or recruiting the participants. The data was collected using a semi-structured interview which lasted between 20-45 minutes per participant. The interviews were tape-recorded and the data was transcribed and analysed using the phenomenological analysis steps. The study was approved by the regional ethical review board. The result of the study shows that the entire participant agreed that prevention of PUs in End of Life (EoL) care is worthwhile and that not all PUs in dying patients can be prevented and this reflects the topic that was reviewed.

Analysis of the qualitative papers highlighted that both Barrakat-Johnson

et al.

(2019) and Carlsson and Gunningberg (2017) papers employed the appropriate research method to explore the thought and experiences of the participants. The validity and quality of their studies were ensured as the authors effectively addressed the processes of qualitative research method which encompasses stating a clear research objective, justified use of current and peer-reviewed literatures which were well-dated and referenced (SIGN, 2019). Barakat-Johnson

et al.

(2019) paper further ensured that the design and procedure of the research were all transparent as it maintained a research audit trail.  Bashir and Marudhar (2018) emphasised that keeping a research audit trail is vital, specifically in qualitative data analysis as it enables the researcher to repeatedly go back through the data for continuous analysis before generating an initial theme. The qualitative studies both adopted a purposive sampling for recruiting their participants. Parahoo (2014) defined purposive sampling as a non-probability selection which is based on the objective of the study and the characteristics of the participants. In Carlsson and Gunningberg (2017) study,the essence of using a

purposive sampling

is that the researchers were interested in the opinions and experiences of the nurses and HCAs as they have direct experience in palliative and End of Life (EoL) care (Iliffe

et al.,

2016). However, purposive sampling is said to be extremely prone to researchers bias because it may be difficult to defend the selected representative of the sample, and the participants can manipulate the data being collected (Harvey and Land, 2017). Hence, the qualitative authors were able to achieve a maximum level of variation by using this sampling system, and this enabled them to look at the averages of the collected data (Barrakat-Johnson

et al.

, 2019; Carlsson and Gunningberg, 2017).

Furthermore, the length of the interviews of the two qualitative studies lasted between

twenty

to forty-five minutes and this is considered an average time for data collection for a semi-structured interview. This was reviewed in Beck (2016) which argued that although the timing for various interviews depends on the topic, participants and the researcher; however, an average healthcare interview was viewed not to exceed sixty minutes. Barrakat-Johnson

et al.

(2019) data was thematically analysed which emphasises on pinpointing, examining, and recording patterns of meaning used within a data (Sinnott, Kelly and Bradley, 2017). Although, Parahoo (2014) identified some of the thematic analysis challenges in the form of inadequate transparency of data coding, difficulty categorising and analysing the credibility of the findings. However, these challenges were avoided in this study (Barrakat-Johnson

et al.

, 2019). Carlsson and Gunningberg (2017) alternatively, used a phenomenological data analysis step. This according to Parahoo (2014) is the means of investigating various ways that people think or experience things, and it was considered suitable because it interprets the way that the participants expressed their views. However, the fifteen participants recruited for this study is considered insufficient for a phenomenological approach because they are not enough for identification of variations and the limited scientific questions used in the study (Zygmont and Naidoo, 2018).


Also, the researchers were bothered about the feelings of the participants and this did not entail pure conception, as a result, the analysis of their different ways of understanding might be questioned from the phenomenological point of view.

Barrakat-Johnson

et al.

(2019) study’s emerging concepts and codes were identified by the authors, as they separately re-read the transcripts to enhance its credibility. Sutton and Austin (2015) stressed that the final stage of qualitative research should be determined by an effective synthesis of the collected data. This is of crucial importance because it is where the participant’s contributions are grouped together to draw a conclusion. Parahoo (2014) expressed that a clearly rigorous research should be both explicit and transparent, thus a researcher can describe to the audience and colleagues what they did in a clear simple language. However, Rotelli (2015) stressed that the confusion that impacts qualitative research trustworthiness and rigor is the tendency of researchers covering their work with jargons and mystery. Thus, the qualitative authors identified the most important questions for establishing a research rigor and attempted to account on how their questions were answered using qualitative data.

Whilst analysing qualitative papers of Barakat-Johnson et al. (2019) and Carlsson and Gunningberg (2017), some limitations appears to be eminent. Although their research objectives were clearly stated and the semi-structured interview guide was reviewed by qualitative research experts however, the selected participants were not involved in designing the pilot study. Kaiser, Thomas and Bowers (2016) stressed that participants involving in research design are important, as they can be clarified of the research questions, ensured the methods were appropriate, review and comment on the interview questions and data collection methods. Additionally, Carlsson and Gunningberg (2017) authors did not pilot the interview prior to the proper data collection, and this questions the study’s originality. Since, the essence of research pilot is to allow the researcher to establish if the design is understandable, clear and able to answer the research questions, and see if any changes need to be done to the main interview schedule (Bice and Parker, 2019). In Barakat-Johnson

et al.

(2019) study, the

experiences of the nurses in o

ther clinical units with a low incidence of PU may not reflect in the result of this study, although, the authors tried to reduce the bias by recruiting experienced clinical nurses from the stated units. In addition, the first author was known to be a senior clinician and may have been familiar with some of the participants, and this may have affected the participant’s responses. Trace and Kolstoe (2017) warns of pitfalls in form of researcher’s role of confusion and lack of objectivity which raises an issue of researcher’s bias as a result of a hierarchical and professional relationship between participants and researchers. Therefore, this would have been minimised by employing a non-clinician researcher who is not familiar with the participants to conduct the interviews.

Furthermore, Van den Besselaar and Sandström (2017) highlighted the importance of mixed gender research to ensure that the results apply to everyone, however, Barakat-Johnson

et


al.

(2019) study was found to be gender-biased as all the participants were females, as a result, the sample did not represent the views of both male nurses and hence might not be transferable. Also, in the Carlsson and Gunningberg (2017) study, the researchers recruited only one male nurse and no male HCA. Evidently, the qualitative studies finding may be limited to a certain group of people (Thompson, 2016). Cislak, Formanowicz and Saguy (2018) agreed that inappropriate representation of both male and female views in healthcare research produces a finding which holds a biased knowledge. As a result, the two qualitative research papers may encounter disparagement in this criterion (Allotey, Allotey-Reidpath and Reidpath, 2017; SIGN, 2018).

The result of Barakat-Johnson et al. (2019) study identified that provision of quality care by the nurses helps to prevent PU related complication, however, they acknowledged that the task was not easy as assumed, judging from the organisational and structural barriers encountered during the research process. The study was f

ound inconclusive as there is a

need for further studies in order to address the distress experienced by the nurses when they cannot give the required care secondary to PU. Additionally, the authors were also assumed to have a preconception of the research topic, as they have clinical experience not only as a senior researcher in palliative care but also as senior nurses, and these questions the researcher’s credibility (Doyle and Buckley, 2016).

This section appraised the two quantitative papers selected for this assignment; these include Charalambus

et al.

(2019) which explored the knowledge and attitude of nurses in a major public hospital in Cyprus towards PU prevention. This descriptive cross-sectional study used convenient sampling to select the nurses. Harvey and Land (2017) viewed convenient sampling as a non-probability type of sampling method where participants are selected because of their easier accessibility. The participants were employed by paraplegic, ICU, orthopaedic, neurological and medical wards because of their daily interactions with patients at risk of developing PU. Data collection was done from December 2014 to February 2015, and there were 60% of the participants who returned their questionnaire giving the 102 number of nurses who participated in this study. Two separate questionnaires were used, these consist of Piper pressure knowledge text (PUKT) and a Likert scale question which allows the participants to answer the questions ranging from agree to strongly disagree thereby granting them the flexibility of answers compared to a yes or no questions. The study was approved by the ethics committee of Cyprus. Pearson test was applied for data correlation and the statistical correlation was set at P=0.05. The result of the study showed that knowledge and attitude of nurses correlated positively (Pearson R=0,223) and is statistically significant (P=0.019). This suggests that nurses have a positive attitude towards PU prevention.

The second quantitative study is a Randomised Control Trial conducted by Kalowes, Messina and Li (2016). They compared the difference in the incidence rate of hospital-acquired PUs (HAPUs) in critically ill patients in the intensive care unit (ICU). Unlike Charalambus

et al.

(2019) study which has only one objective, this study has three objectives which were first to determine the difference in the incidence rate of sacral HAPU formation between two groups of critically ill patients. Secondly to examine the risk factors for the development of HAPU. Thirdly, to explicate the cost with regards to the use of foam dressing in the prevention of PUs. A convenient sampling was also used to select 366 participants, 184 were randomised to have a 5-layered soft silicone foam dressing applied to their sacrum (intervention group) and 182 received the usual PU care (control group). The result suggests that the rate of HAPU was considerably less with patients in the intervention group than those in the control group with (0.7% vs 5.9%) and is statistically significant (P=0.01).

Analysis of the quantitative studies indicates that a convenience sampling was used to select the participants for both studies (Charalambus

et al.,

2019; Kalowes, Messina and Li, 2016).  Although this sampling system was used by Kalowes, Messina and Li (2016) to recruit its participants, however the continuation of the study stops as soon as the patient leaves ICU and they were monitored using electronic hospital records, as a result, this may impact the validity of the study (SIGN, 2019). In Charalambus

et al.

(2019) study, the 102 participants completed the questionnaires on the site and were given the opportunity to consult other resources or existing guidelines. According to Martínez-Mesa

et al.

(2014), having a minimum of 100 participants is ideal sample size for large population research. Conversely, factors such as an estimated response rate and the nature of the proposed data analysis can also determine sample sizes. Kalowes, Messina and Li (2016) study considerably adopted the RCT method because randomisation enables direct comparison between two groups, and reduces bias thereby providing an accurate representation of the result for effective generalisation to the wider population (Rothwell

et al.,

2014).

Some limitations evolved whilst analysing the quantitative studies, and these include the fact that Charalambus

et al.

(2019) study did not provide an extensive reason for excluding some units who care for patients with a high risk of PU, according to Cislak, Formanowicz and Saguy, (2018) this may affect the generalizability of their findings. Additionally, a high number of ICU nurses (44.1%) which statistically have a high impact on the positive attitude score was recruited.

Ross, Iguchi and Panicker (2018

) stressed that unequal representation of the participants among the selected units may have created a bias. In agreement,

Siepmann

et al.

(2016)

stressed that bias may arise as there could be systemic errors which may lead to deviation of the result due to flaws in either the reporting, conduction or the design of the trial. In-line with SIGN (2019), as the data was collected through a self-report survey, therefore errors may have occurred through the collection process. In agreement, Gadermann

et al.

(2018) insist that self-report studies often have validity problems as it is difficult to measure or examine, also it can bias the participant’s feelings at the time they filled out the questionnaire. Additionally, there may be an increased risk of bias as it was impossible to blindly collect data with regards to the nature of the treatment and the intervention, because it is only the researcher who knows the effect of the treatment and the strength of the trial (Wartolowska, Beard and Carr, 2018).

Furthermore, having limited Kalowes, Messina and Li, (2016) study to a single-site, may impact on the generalisability of the result, as it may be different when carried out as a multisite study. However, Boland, Karczewski and Tatonetti, (2017) stressed that the quality of a study will be questioned if it did not encounter the complex challenges of multi-site collaboration, such as passing through various hospital restrictions and guidelines, managing an enhanced data sharing and large-scale data analysis. Additionally, the credibility of the study’s objectives may be impacted as the result cannot be generalised to every patient but can only be related to the context of critically ill patients in the ICU. Moreover, the effectiveness of the foam dressing cannot be referred to other parts of the body as the trial was limited to the sacral pressure area. Therefore, it should be investigated on all the bony prominences of the body and tried among other high-risk patients in the emergency departments, operating rooms and all other areas of care with increased development of PU in order to effectively address the study’s first objective.

To ensure a high standard of clinical research is obtained, the research governance policy is implemented in National Health Service (NHS) through the Health Research Authority (HRA) to safeguard the interest of the participants (

NHS, 2017

). Also, National Institute for Health and Care Excellence (NICE, 2018) research governance policy emphasised on the management risks involve in some research activities and elaborated on the safety of both the researcher and the participants. This ensures that all research protocols are adhered while developing the research proposal, registering the research activity, information governance, reporting research results and research misconduct. Therefore, adhering to the guidelines and management of risk is an important aspect of research governance (NICE, 2018).

Evaluation of the studies suggested that they adopted appropriate research governance when conducting their individual researches. In-line with the World Medical Association Declaration of Helsinki (2014), the authors ensured that their studies were approved by their individual human research ethics committee. Additionally, to protect the participant’s rights and welfare, the ethical standard was upheld by the researchers as each participant was informed of the aim of the study

, and both oral and written consent was also obtained from them. This was to enable the participants to make a voluntary decision either to accept or decline to participate in research (Peter, 2015). Also, confidentiality was ensured as there was a de-identification of the participants during data entry into the electronic secured database, and this is in line with the ethical principles in conducting research (Parahoo, 2014; Novak, 2014).  Effective use of the research ethics is part of promoting patient’s rights, thereby observing the Helsinki’s Declaration. Beauchamp and Childress (2012) stressed that research ethics of autonomy is upheld when participants can independently decide whether to participate in a research or not. In view of the four studies, they respected the right to patient’s autonomy and ensure their safety during the research process. Carlsson and Gunningberg (2017) study elaborated more on transparency, as it provided the participants with options to voluntarily withdraw from the study at any time without explanation.

Beauchamp and Childress (2012) emphasised that the principles of beneficence and non-maleficence should be attained in order to safeguard the participants in research studies. The principle of beneficence proposes that the benefit of any study’s method outweighs the potential risks, while non-maleficence elaborated on doing no harm. Thus, as some of the studies involves exploring the participant’s experiences of PU management, there was no potential harm identified by the process

of their data collection, and thus there was no plan in place to manage the psychological effect on the participants. However, Petkovic

et al.

(2018) insist that every research comes with a degree of potential harm, and this may occur as a result of altered behaviours, discrimination, privacy concern, data misuse, discomfort, offence or negative reaction. Additionally, Carlsson and Gunningberg (2017) study did not make preparation for management of any potential harm as it deliberated on a sensitive question relating the EoL of patients. This topic of review can have a distressing effect on the participants, as a result, necessary plans should have been arranged, as the interviews can bring back traumatic experiences (White, 2017; Parahoo, 2014).

The four studies were approved by the ethical review board of each research hospital. According to Lee (2018), obtaining a clinical research ethics approval before beginning the procedure provides the assurance that the research has the potential to contribute to clinical knowledge and that the welfare and rights of the patients are protected. However, in the RCT conducted by Kalowes, Messina and Li (2016) ethical consideration of consent was exempted by the committee for this type of research, as the selected participants were all critically ill patients. Alternatively, a letter was provided to the next-of-kin of the participants informing them that their relative had been enrolled in this study, stating the aim and giving them the option to withdraw from the study at any time. However, this impacts the credibility of the study as the researchers did not gain the next-of-kin’s approval before enrolling them into the study thereby bridging their ethical right to consent voluntarily (Lee, 2018).

In view of the analysis, it is evident that there are numerous distinctions between the qualitative and quantitative method of research. The studies applied different methodologies, population and ethical considerations, and this shows the diversity between the two main research approaches often used by nurse researchers (Bashir and Marudhar, 2018). Whilst analysing the qualitative papers, they were found to be subjective, according to Walby and Luscombe (2018) this method is often applied when conducting a social or behavioural study such as human interactions which is of crucial in the nursing profession for development of trusting relationships with the patients. Dowling, Lloyd and Suchet-Pearson (2017) described qualitative research as an inductive, emergent and naturalistic approach for obtaining people’s perception of situations and experiences. Although, these are based on the exploration of relationship, social setting and human experiences which enables a face to face and personal contact during data collection (Moser and Korstjens, 2017; Bashir and Marudhar, 2018). However, the qualitative methods are very interpretative and uses smaller sample sizes, also its findings are transferable, unlike the quantitative research which acknowledges the use of generalisability (Siepmann

et al

., 2016; Peter, 2015).

Therefore, nurses effective use of qualitative research method will enable them to gain knowledge of the attitudes, behaviours, beliefs, experiences, opinions and interactions of the patients, in so doing obtain their insight and thoughts.

Alternatively, the quantitative papers relate to objective testing and controlled experimentation which ultimately rejects or supports a hypothesis, and these steps are said to consistently reduce bias when collecting and analysing data (Jervis and Drake, 2014). It was also shown that the hierarchy of evidence produced in this method of study is much higher than the qualitative studies as it analyses large sample sizes, and the researchers focused on the need for precise measurement, control, prediction and replicability (Savela, 2018). Therefore, adoption of the quantitative method in clinical trials helps to measure the cause and effect relationships, and the correlation between variables, and this helps clinical nurse researchers determine the most effective form of treatment or patient’s intervention (Harvey and Land, 2017).

In conclusion, various studies carried out on the management of PUs were examined using four different research articles and these were extensively appraised with regards to their individual methodologies, findings, ethical considerations and research governance. Different research methodologies with respect to design were appraised. The qualitative and quantitative papers explored showed distinctions between them although both approaches show comprehensive and exhaustive evidences which support evidence-based practice. The study has established that as much as qualitative and quantitative research approaches are relevant and have strength in health care decision making based on evidences, they also have weaknesses. This appraisal also establishes the article quality and the position of each article on the hierarchy of evidence-based studies. However, this essay is limited as it did not synthesise the findings from these articles after appraisal and there was no systematic review article appraised to show a wider understanding due to the limitation in word count. The findings from the various studies are crucial to the management of PU and hence more research in this area should be encouraged.

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