MRI Protocols in Prostate Cancer Detection

Introduction

PCa is the leading cause of malignant cancer deaths in men and this has led to an increase in the number of new PCa diagnoses per year because of increased public awareness. Therefore, MRI is a modality of choice for investigating PCa diagnosis because of its diagnostic accuracy and non-invasiveness compared to trans-rectal ultrasound scans, biopsies and digital rectal examinations (DRE) (Jie, Rongbo and Ping, 2014). However, current literature seems to have conflicting conclusions concerning the best imaging protocol for PCa detection and localisation. Some suggest that a non-contrast bp-MRI study performed at 3Tesla (T), magnetic field strength is sufficient (Fascelli, et al., 2016), others suggest that a dynamic contrast-enhanced multiparametric MRI study (DCE-mpMRI) performed at either 1.5T or 3T should be the protocol of choice (Wang, et al., 2014). Therefore, the aim of this research proposal is to establish whether the bp-MRI protocol at 3T is sufficient for prostate cancer detection and localisation, eliminating the need for a contrast-enhanced study and could become a protocol of choice in MRI departments with 3T scanners. A systematic review (SR) is the chosen methodology in this proposal.

Therefore, the objectives of the study are:

To save MRI departments time by using this shorter protocol compared to the DCE-mpMRI study.

Increase the cost-effectiveness of the examination

Eliminate the risks associated with the administration of gadolinium-based contrast agents (GBCAs).

Literature Review

Rationale for the study

With a high demand for prostate gland imaging in our department, an average of 40 examinations per week, and PCa being the leading cause of death in men (Grant, et al., 2014), and current literature advocating for 3T DCE-mpMRI studies, this review was undertaken to establish the validity of the bp-MRI protocol in the diagnosis of PCa. The rationale is that the bp-MRI protocol would limit examination costs, save time and eliminate the risks associated with GBCA administration.

Multi-parametric Prostate Examination

According to Fascelli, et al. (2016), and Mussi, et al. (2017), the DCE-mpMRI is useful in demonstrating both the anatomical and functional information of the prostate gland, providing accurate detection, localisation and staging of PCa. Grant, et al. (2014), also added that the DCE-mpMRI is the ideal tool for localising suspicious lesions that can be biopsied. Mussi, et al. (2017), further elaborate that the DCE-mpMRI decreases the number of unnecessary biopsies and the over diagnosis of insignificant tumours. However, Scialpi, et al. (2017), disagreed by stating that the DCE-mpMRI does not display any remarkable change in its performance as a diagnostic tool in addition to the bp-MRI protocol. De Visschere, et al. (2016), agreed that the DCE-mpMRI adds insubstantial value over the bp-MRI protocol when using the Prostate Imaging Reporting and Data System version 2 (PIRADSv2) for diagnosis of clinically significant PCa in patients with high levels of prostate specific antigen (PSA). However, the value of the DCE-mpMRI has been questioned as is argued by Fascelli, et al. (2016), Mussi, et al. (2017), and Hausmann, et al. (2018). They concurred that it increases both the costs of the examination because of GBCA administration, and the examination time, poses an allergy risk and deposition of gadolinium in the globus pallidum of the brain. Controversy surrounds the DCE-mpMRI with some writers stating that it has increased sensitivity, it improves DWI scores, others state that it plays a minor role in the detection of PCa and has the same diagnostic accuracy as the bp-MRI (Junker, et al., 2019).

Biparametric Examination

Consequently, a shorter protocol was developed to improve patient comfort, eliminate allergy risks and increase patient throughput. The high resolution T2-weighted axial sequence forms part of this protocol, and when performed with an axial DWI, it can potentially replace the DCE-mpMRI (Mussi, et al., 2017). The axial T2-weighted and DWI sequences are useful in detecting PCa as written by Fascelli, et al. (2016). The DWI sequence however, needs to have high b-values and ADC maps. Stanzione, et al. (2016), also written that the T2 –weighted sequence detects lesions in the transition zone (TZ), whereas the DWI is superior in detecting lesions in the peripheral zone (PZ) according to the PIRADSv2. Turkey and Choyke (2015), explained that the PIRADSv2 was established in 2015 by the European Society of Urogenital Radiology to standardise the reporting of prostate imaging. It governs scanning protocols, clinical indications and assessments. It uses an assessment score of between 1-5 where 1 is a very low probability of cancer and 5 is a very high probability of significant cancer and its locations. The T2-weighting offers images of high spatial resolution. It is generally easy to acquire, it is non-invasive, suitable for all patients even those with prosthetic hip replacements and is less prone to artefacts. It has a high signal-to-noise ratio and provides superior soft tissue contrast images which correlates with one of the requirements of the PIRADSv2 (Nketiah, et al., 2017). On the other hand, Wang, et al. (2014), stated that the DWI is also easy to acquire and process, compared with other advanced MRI techniques. The DWI uses a parameter known as the b-value that affects the diagnostic accuracy of the ADC and image interpretations. However, there are conflicting opinions about the optimum value needed for cancer detection, but Grant, et al. (2014), Fascelli, et al. (2016), and Hausmann, et al. (2018), agreed that the DWI sequence needs to have a high b-value. Most writers agree on b-values of 1000 to 2000s/mm2. They agree that the higher the b-value, the better the sensitivity to tumour detection. Hausmann, et al. (2018), written that the T2-shine through effects caused by a low b-value can deplete the diagnostic accuracy. Since the DWI delineates lesions in the PZ and assesses general tumour aggressiveness, this leads to plans for therapy, which predicts patient outcomes. This comes at a reduced cost, shorter imaging time, non-invasiveness minus the risk to contrast media allergy. Therefore, the DCE-mpMRI is unsuitable to be a primary screening tool because of its high cost, limited availability and longer examination times but can be used as an additional sequence to further evaluate prostate lesions especially for extra-capsular extension. Stanzione, et al. (2016), agreed that the DCE-mpMRI should be used as a secondary tool in providing additional information for PZ lesions if the PIRADv2 score is 3. Therefore, the DCE-mpMRI becomes inferior to the bp-MRI when PZ cancers are suspected at DWI. Therefore, Mussi, et al. (2017), concluded that with the increased sensitivity of the DWI in the PZ, any lesion smaller than 1.5centimetres is given a score of 5, and when the bp-MRI is of diagnostic quality, the DCE-mpMRI becomes inferior.

Gadolinium Safety

Heverhagen, Krombach and Gizewski (2014), stated that administering GBCAs to patients is risky in that there could be allergic reactions. This allergy risk occurs in approximately 2.4% of cases according to Mussi, et al. (2017). Patients with impaired renal function, those on dialysis, those with chronic kidney disease and acute kidney injury and those with previous liver transplants could be at risk of developing Nephrogenic Systemic Fibrosis (NSF). NSF is a scleroderma-like disease of fibrosis of the skin and internal organs like the liver, lungs, heart and muscles with associated pain.

Gadolinium deposition in the brain

According to Gulani, et al. (2017), repeated injection of GBCAs can cause deposition in the brain tissue, notably in the dentate nuclei and globus pallidus. The significance of this occurrence remains unknown. However, there are concerns about the locations of the deposition and the question remains whether this may cause any harm in the long term.

Conclusion

Having completed this literature review, it is clear that there is contrasting evidence about the two protocols of diagnosis for PCa. Each protocol has its own strengths and weaknesses. Therefore, the purpose of this proposal is to establish the validity of the bp-MRI in the diagnosis of clinically significant PCa. If this protocol is deemed as a first choice for prostate imaging after the research study takes place, this would save MRI units examination costs and time, increase patient throughput and eliminate the risk of allergic reactions due to GBCAs administration. The T2-weighted imaging is widely available and can be performed on anyone without causing any artefacts and the DWI is easy to acquire compared to other MRI advanced MRI techniques. When the optimum b-value is selected, the diagnostic accuracy of the examination is enhanced. This would be in accordance with the writing of Gallin and Ognibene (2012), who explain that ethical research must add value and knowledge that is useful in further understanding concepts that improve health-care services.

Methodology

Methodology refers to particular strategies and approaches used to identify, select, process and analyse data. Clarke (2011), writes that Systemic Reviews (SR) summarise all available primary research and endeavour to respond to a research question. They are also known as secondary research and they are reliable sources to improve and guide clinical practice.

Search Strategy Used:

As recommended by Aveyard, (2019), a systematic search strategy was used for computerised literature search through the university’s online library was conducted. This included books, articles, journals and data bases. The search ensued finding literature that is authentic, reliable, peer-reviewed and has open access eliminating the need of a purchase. The search included the exhaustive search of the databases Cochrane library, the Sage Research Methods Online (SRMO), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Google Scholar and the United States National Library of Medicine (MEDLINE). English publications from between the years 2014 and 2019 were searched, in order to find current and relevant literature of five years and under.

Research Philosophy:

Lindsay, (2007), concurred that paradigms are general theories that influence the operations and outcomes of a research process. They are divided into positivist and interpretivist.

Research Paradigm

Positivist and Interpretivist

There are chiefly two sorts of research theory, positivism inquiring about way of thinking and interprevism look into reasoning. As referenced by Antwi and Hamza (2015), positivism theory is the one that manages the investigation and assessment of the exploration issue through the obtained truth and apparent realities from confirmed sources. In this manner, positivism reasoning depends on experimental perception and has the key expected to clarify and anticipate results through logical realities. As censured by O'Gorman, et al. (2014), interpretivism look into theory manages the created impression of the people about a specific circumstance over a specific range of time. Since, the view of people fluctuate from individual to individual in this manner it brings about rising likelihood of utilization of controlled information that go about as a block to the examination. Along these lines, it very well may be inferred that by utilizing positivism theory a coherent investigation of the gathered information is made in this manner assisting with assessing the exploration issues with the utilization of truthful subtleties and confirmations. Moreover according to Lindsay, (2007), dwells on generalisability, the research findings being observable and quantifiable this in turn leads to statistical analyses. It is aligned with quantitative methods and analysis. The interpretivist research focuses on understanding and relativism and is also known as the relativist paradigm.

Justification of the Utilization of the theory of Postivism:

The positivism inquire about way of thinking has been decided for this examination since it permits the analyst to make sensible translation just as basic audit of the realities required for researching the investigation point. As remarked by Leppäaho, et al. (2016), positivism utilizes a basic structure for executing the examination in this way making reduced space for experiencing errors in research. In addition, positivism permits lower proclivity for variable and intense changes consequently helping the scientist to execute exact investigations and application by observing explicit principles (Mingers, 2015). Further, positivism permits dependability and incorporates logical suppositions to execute the examination in this manner the utilization of positivism is obvious in light of the fact that it assists with executing blunder free research results.

Experimental and Naturalistic

The research study utilizing the experimental approach is an examination that carefully sticks to a logical research plan. It incorporates a theory, a variable that can be controlled by the scientist, and factors that can be estimated, determined and thought about. Above all, research involving experimentation is finished in a controlled situation. Logical experimentation assists with deciding the idea of the connection among free and ward factors. While it is regularly troublesome, or now and again unthinkable, to control a solitary variable in an analysis, researchers frequently work to limit the quantity of factors being controlled (Kohl, et al., 2012). The researchers can study whatever variable by identifying and isolating it. However, in healthcare settings this can be a challenge, therefore sampling and randomisation can be used to produce a controlled situation. Randomised controlled trials and cohort studies can be considered suitable for this category of research study (Lindsay, 2007). Naturalistic perception is a non experimental, fundamentally subjective research strategy in which life forms are concentrated in their normal settings. Practices or other marvels of intrigue are watched and recorded by the scientist, whose nearness may be either known or obscure to the subjects. This methodology falls inside the more extensive class of field study, or research led outside the lab or organization of learning. Controlling of the environment is not associated with naturalistic perception, as the exercises of intrigue are those showed in ordinary circumstances. This strategy is every now and again utilized during the underlying phase of an examination venture, both for its abundance of distinct worth and as an establishment for speculations that may later be tried tentatively. In this approach situations are directly or indirectly observed using methodologies such as ethnography, grounded theory and phenomenology. In ethnography, communities are studied through observations and interviews. Grounded theory uses coding and classification of data to enable theories to be obtained from the data as it is analysed (Beuving, et al., 2015).

Study selection

Porritt, Gomersall and Lockwood (2014), write that study selection is important because it ensures that the results obtained from a SR are credible and can influence health-care policies, practice and future research. Recommendations are that only studies which fall under the pre-defined criteria should be selected. The studies selected should also go through critical appraisal, the purpose being firstly, to exclude low quality studies that can potentially compromise the validity, and secondly, to identify the limitations and strengths of the studies. Therefore only those studies were kept which met the criteria of selection.

Inclusion Criteria

In this proposal, the population will include of men aged 50 and above, suspected of having PCa, those with a family history and those with abnormal findings on DREs. In this age group, only patients with a PSA value of ≥ to 4ng/ml will be included as this could be indicative of PCa. Mixed methods studies with ethical principles will also be included.

Exclusion Criteria

The proposal will exclude patients below the age of 50, those with a PSA value of less than 4ng/ml, follow up scans and radical prostatectomy. Those having some form of therapy and those with a known diagnosis of PCa will also be excluded as these criteria do not qualify in primary studies. Patients with hip replacements will also be excluded because the interpretation of the DWI is affected because hip replacements cause artefacts on the MRI images. Incomplete scans will also be excluded as well as any publications not written in English.

Study Design:

Justification of mixed methods in Systematic Reviews

Hickson (2013), and Bell (2014), concurred that research methods are the techniques which are employed for conducting research, including tools, data collection and analysis. They are largely classified into quantitative, qualitative and the relatively new mixed methods. McCusker and Gunaydin (2015), concurred that qualitative approach is appropriate if the researcher aims to understand how a particular issue is perceived by generating answers from the why, how and what of a phenomenon, rather than a quantifiable method. However, the quantitative approach collects numerical values for analysis (Lindsay, 2007). The data can be in the form of statistics and percentages. The main advantages of this method as stated by Weaver and Olson (2006), are that it is generalisable, findings can be used in any other sample, it describes and predicts results, and it is objective and credible. With this in mind, this proposal will use the mixed methods approach. Mixed methods are frequently used in health-care research in solving research questions which are generally challenging, but offer multi-dimensional insights. The blended examination translation of both subjective and quantitative was believed to be suitable as communicated by Curtis, et al, 2013 quantitative research is truthful and exploratory, which implies it might be imitated by anybody as long as comparative standards of the essential research are being met, which is completely one favoured situation to its use while qualitative or subjective research plans to give signs of progress understanding through direct seeing, reasonable revealing, and references of legitimate discussions. It intends to see how the people get noteworthiness from their regular factors, and how their significance impacts their direct. Also, it thinks about, analysts or researchers to react to very certain requests, as point by point in a bit of the picked articles. All the 9 articles got for the survey reason comprise of both quantitative and qualitative logical confirmations. When considering about the location or setting of the articles screened, 3 articles are conducted among the population of the United States Of America, 3 were conducted in European countries like Germany and Italy , 1 in Belgium, 1 in China and another 1 in Norway. Therefore the population represents a broad setting and therefore the findings can be generalised throughout any population though the literature review lack any population size as a representative of Asian origin. Among the 3 studies of the United States, the study design adopted by the two studies were retrospective study based on single or multiple institutions and another one was a cohort study. Similarly, among the 3 studies conducted in the European continents, one is qualitative study, another one is focus group study and another one is prospective case note review. When considering about the study conducted in Belgium, the study design is quantitative focus group population study, the study conducted in China is a retrospective one and the one conducted in the Norway is among the focus group. With the inclusion of concentrates from a variety of regions in general infers that as a researcher, we can start to develop the confirmation base by observing examples that occur in a wide range of conditions. It furthermore contemplates and makes us to consider the qualification in condition and economics, which may really influence the results. When studying about the sample size of the different studies, the study conducted by De Visschere, et al. (2016) represented the highest sample size of 245 patients chosen with enhanced levels of PSA. The study was conducted for 2 years with focus sample population. The next study with second highest sample size is 118 conducted by Mussi, et al. (2017) in the Brazil. The study was conducted for a period of 18 months and it demonstrated that the clinically significant prostate cancer was among 48 patients. Grant, et al. (2014) conducted study with population size of 106 patients for overall period of 8 months. Similarly studies conducted by authors Hausmann, et al. (2018), Nketiah, et al., 2017, Fascelli, et al. (2016) and Wang, et al. (2014) all included sample size within 100 patients of the focus group. I acknowledge there was an appropriate mix of test sizes, with 2 examinations over 100 individuals and the other 6 assessments have individuals of small size within 100 individuals. The gigantic example sizes engage pros to summarize information discoveries, regardless; these were data dependent on optional examinations meaning researchers couldn't partake in the structure and technique with the exception of consistently contemplates of the dated information. On the other hand, assessments led with little size populace considered experts to have significantly increasingly a quick, key methodology concerning the individuals and the sort of information they considered to get in contrast with what they need. Four of the assessments were longitudinal, hence it was significant to investigate the example in points of view or practices for example. Regardless, the exactness and steadfast quality must be purposely considered as instructive records may not be done, which implies assessments become progressively hard to basically evaluate. Huge sample size populace studies confine decision power due to factors which are perplexing in nature. Among the rest one depended on randomized control preliminaries or cohort studies (Bowling, et al, 2014). A critical piece of the data over the examinations was accumulated by methods for recognition, overviews dependent on polls, gatherings, scales and plans. It would have been all the more intriguing to find some elective articles with theoretical concentrations or approaches used, particularly as they would be proper to the assessment topic.

Criteria for including studies

The Arrivé Scale

Burls (2014), defines critical appraisal as a process that systematically reviews research to determine its trustworthiness, significance and relevance. Scales are tools used to assess the quality and the results obtained are used to create a general overview of the quality of the study. The Arrivé scale was developed to enable the evaluation of methodological standards applied to any clinical studies of radiology examinations (Arrivé, et al., 2000). It has 15 standards that are explained in detail in Appendix 4 and the Appraisal Tool as Appendix 5.

The Analysis of the key literature using the Arrivé Scale

The study conducted by De Visschere, et al. (2016) was a retrospective one with a specified aim to decide the additional estimation of dynamic contrast enhanced imaging (DCE) over T2-weighted imaging (T2-WI) and diffusion weighted imaging (DWI) for discovery of clinically critical prostate malignancy (csPC) among patients with raised prostate-explicit antigen (PSA). The study included 245 patients with raised PSA experienced the multiparametric (mp) magnetic resonance imaging (MRI) of the prostate before biopsy based on the set inclusion and exclusion criteria. The study was done using a structured methodology with updated scientific examinations along with accurate analysis of the data statistically. The MRI discoveries were scored by the Prostate Imaging Reporting and Data System form 2 (PI-RADSv2) and an elective generally evaluation classification (PI-RADSv2Alt) in view of just T2-WI and DWI. Among 144 patients (58.8%), csPC was found inside 2 years after MRI. With scoring as indicated by the PI-RADSv2 rules, DCE was not required for assurance of the general appraisal class in 80.8% (198/245) of patients. Receiver operating characteristic (ROC) examination demonstrated a zone under the bend of 0.79 (95% certainty interim: 0.74-0.85) for PI-RADSv2 and 0.79 (95% CI: 0.73-0.85) for PI-RADSv2Alt. For the second study conducted by Grant, et al. (2014) was single institution based retrospective one which was carried out for a period of 8 months with sample size of 106 patients. The study was conducted with structured methodology as follows: Signs for prostate mpMRI were prostate malignant growth discovery in patients with raised serum PSA with or without earlier irregular transrectal ultrasound (TRUS) biopsy, and staging based on local measures for recently analyzed disease. Inclusion measures were (a) having a mpMRI of the prostate, which likewise included obtaining of high b-esteem DWI, and (b) resulting MR/TRUS combination guided prostate biopsy of the sores recognized on mpMRI. 170 patients were rejected since they didn't have MR/TRUS combination guided biopsy. Furthermore, 60 patients were barred in light of the fact that high b-esteem DWI was not acquired. At long last, fourteen patients were again rejected because of relics (for example hip substitutions). The last examination populace comprised of 106 patients. The middle age of the included patients was 65 years (mean: 64 years, extend: 43–78 years). The middle serum PSA esteem was 5.35 ng/mL (mean: 7.9 ng/mL). The normal time to MR/TRUS combination guided biopsy following prostate mpMRI was 28 days (extend: 1–109 days, middle: 23 days, mode: 1 day). The findings highlighted that more injuries were noticeable on procured b=2000s/mm2 contrasted with b=1000s/mm2 DWI. Determined high b esteem DWI utilizing the IVIM model had around indistinguishable number of injuries from obtained high b esteem DWI though the DK model had less sores than gained pictures. The picture nature of determined b1000IVIM was equivalent to that of procured DWI in apical/mid/base (98%) areas and practically identical in low apical and front (95.4%) areas. The picture nature of determined b2000IVIM was mediocre in both apical/mid/base (86.2%) areas and similar in low apical and front (83.9%) areas. The study was conducted with recent relevant references and study findings justified the rationale of the research undertaken. Another similar important study conducted by Mussi, et al. (2017) was considered to be significant for the review purpose. The study design was a retrospective one with those patients who had undergone MRI and followed by fusion biopsy. The study utilized significant population size of 118 patients with an aim to think about the after effects of MRI with and without enhanced contrast arrangements for the discovery of clinically noteworthy prostate malignant growth. The estimation of differentiation in the MRI convention for the discovery of prostate tumors has been talked about in past studies. The assessment films were perused autonomously by 2 per users in 2 meetings: first without differentiate upgraded pictures and second with differentiate improved pictures. The pictures were evaluated by the doubt of clinically noteworthy prostate malignant growth (scale, 1-5). The kappa coefficient was utilized to contrast the readings and without differentiate. The affectability, explicitness, positive prescient worth, negative prescient worth, and precision for the two perusers were determined utilizing the biopsy discoveries as a kind of perspective norm. The level for measurable noteworthiness was set at P < .05. The study findings highlighted that an aggregate of 118 patients were incorporated, and clinically noteworthy prostate malignant growth was found in 48 patients (40.7%). The MRI discoveries on both complexities upgraded and non contrast-improved pictures had no factually critical contrasts for either peruser (P > .05 for all degrees of doubt). The affectability extended from 68.3% to 80.7%, explicitness from 57.1% to 77.1%, positive prescient incentive from 29.9% to 38.8%, negative prescient incentive from 88.0% to 91.3%, and exactness from 60.6% to 73.0%. Therefore the study findings gave a detailed justification of the set methodologies and the study findings were analysed using statistical tools that enhanced the power of the study. Another study which should be considered for the analysis was conducted by authors Fascelli, et al. (2016) was a cohort study with population size of 59 patients. The study was with an aim to approve the utilization of biparametric (T2-and dispersion weighted B-MRI and prostate-explicit antigen (PSA) or PSA thickness (PSAD) in a naive biopsy accomplice cohort study sample in danger for prostate malignant growth (PCa). The study utilized proper methodology as all patients’ experienced PSA screening and computerized rectal test preceding a B-MRI followed by MRI or transrectal ultrasound combination guided focused on biopsy. Recently announced composite equations fusing screen positive injuries (SPL) on B-MRI and PSA or PSAD were created to boost PCa detection. The above plans were utilized in the new test set to approve the underlying formulas. The results highlighted that screen positive sores on B-MRI had the most elevated affectability (95.5%) and negative prescient estimation of 71.4% contrasted and PSA and PSAD. B-MRI altogether improved affectability (43.2-72.7%, P = .0002) when joined with PSAD. The negative prescient estimation of PSA expanded with B-MRI, accomplishing 91.7% for B-MRI and PSA for Gleason ≥3 + 4. General correctnesses of the composite conditions were found to be 81.4% (B-MRI and PSA) and 78.0% (B-MRI and PSAD).Validation with a population of naive biopsy population showed the parameter SPL performed superior to PSA or PSAD alone in precisely identifying PCa. Therefore the study choice was found to be in accordance with the research question. In this regard, the study conducted by Scialpi, et al. (2017) must be mentioned which was with an aim to look into about the significance of DCE-MRI likewise showing the potential contribute of bpMRI approach (T2WI and DWI) and volume of injury assessment in the determination and the executives of suspected PCa. DCE-MRI, didn't reveal any noteworthy change in demonstrative execution notwithstanding DWI and T2WI [biparametric MRI (bpMRI)] which speak to the overwhelming arrangements to distinguish suspected injuries in transitional (TZ) and peripheral zone. In clinical practice, the advancement of imaging strategies, assessment conventions and 3D programming improved determination of normal and strange malignancies. Particularly, mpMRI adjusted the way to deal with the patient with dubious of PCa and turned into a helpful apparatus to recognize clinical huge disease. Be that as it may, gadolinium, long test times and greater expenses speak to limits for mpMRI. The article conducted a systematic review on the concerned issue with updated scientific evidences and therefore this study was chosen for the review purpose.

Quality Assessment – Appraisal of Rigour

Cypress (2017), further explains that trustworthiness consists of four elements namely, credibility, transferability, dependability and confirmation for any research study.

Credibility

Noble and Smith (2015), and Hammarberg, Kirkman and De Lacey (2016), describe credibility as the criterion when a study represents participants’ experiences. It takes into account different viewpoints that could also result in bias. Credibility is also affirmed by using triangulation, which is defined as answering a research question in several ways.

Transferability

It evaluates external validity. A study meets this criterion when its findings can be applied to other groups and contexts

Consistency

Also known as dependability, it assesses the reliability of the research, ensuring that the research methods used are clear and transparent. It also aims to reproduce the results given a similar situation.

Confirmation

It acknowledges the interaction with participants and the research methods in acquiring the results. It conforms to credibility, dependability and transferability.

Quality Assessment – Ethical Appraisal

According to Guraya, London and Guraya (2014), ethical reviews are mandatory in medical research because they protect the welfare and rights of patients. Therefore, in order to achieve this, there are seven principles of ethics that need to be observed in all research projects as described by Agianto (2016). These are beneficence, non-maleficence, fidelity, justice, veracity, confidentiality and respect for autonomy.

Beneficence

Bonney (2014), writes that beneficence is maximising benefits to the patient, promoting what is good and achieving the best for the patient. In this proposal, beneficence will be displayed by the primary research affording patients a diagnostic MRI examination of the prostate gland, with the objective of adding new knowledge to the area of study. The patient will benefit by getting a diagnosis and subsequent treatment if needed. However, in qualitative research, participants may not directly benefit from their inclusion in the process, but may have a psychological benefit known as a cathartic effect from someone to tell and listen to their experiences (Doody and Owen, 2016).

Non-maleficence

Farrimond (2013), explains that this principle emphasises on protecting the patients from all forms of intentional harm and to minimise the potential risk of. Potential risks take many forms as described Agianto (2016), and these include physical harm, unforeseen side-effects from a drug trial, psychological or emotional harm. In this proposal, psychological and emotional harm can stem from the fear of the outcome of the scan results and claustrophobia caused by being in the MRI scanner. Moreover, in this proposed study, patients may need to be cannulated, which causes some discomfort, if the DCE-mpMRI is deemed the appropriate protocol for their diagnosis. Therefore, non-maleficence is balanced against beneficence because the benefit outweighs the risk of harm and it requires health-care professionals to maximise the benefits and minimise harm.

Fidelity

Fidelity is described as the obligatory requirement of the researcher to be truthful and keep promises, making sure that the participant understands the risks involved (Agianto, 2016). It involves trust, honesty and integrity. In this proposal, the patients would have been informed about the purpose of using the different protocols to answer the research question, its outcomes and the possible adoption of a new protocol.

Justice

Agianto (2016), describes justice as fairness which is particularly paramount in recruiting participants. Furthermore, Doody and Noonan (2016), add that justice consists of two aspects which are equality and equity. Participants should be selected for the sole reason of the study rather than for convenience. This proposed study will include only male patients from the age of 50. Within this study population, only patients with a PSA value of ≥ 4ng/ml will be included in the study. Prostate Cancer UK (2019), states that this is in line with observing the current guidelines regarding PCa diagnosis.

Veracity

It is the process of ensuring that the participant is fully aware of all aspects of the study and they are kept informed throughout the whole time. No information should be withheld and there should be no deception (Agianto, 2016).

Confidentiality

Doody and Noonan (2016), write that confidentiality requires that information given by participants must not lead to their identification. Their information should not be available to anyone without their consent. In order to achieve confidentiality when data is analysed, codes or pseudonyms should be used so that the participants’ data is not directly linked to their name. The identity of the participant must be protected at all times, especially where small samples are used. No-one should have access to this information except the researcher and those that are authorised during the consenting stage. Confidential information should not be published in the final report of the study.

Autonomy

As described by Agianto (2016), autonomy is respecting a participant’s capabilities and their ability to make their own decisions without coercion. Gallin and Ognibene (2012), explain that autonomy takes into account IC, which itself is divided into three components namely, information, understanding of the research process and willingness and not coercion. Patients need to be informed about the purpose, nature, consequences and risks of the study and should freely consent.

Ethics in Systematic Reviews

Vergnes, et al. (2010), explain that to maintain the integrity of ethics in SRs, is that the author of the original study can be contacted to give their informal consent to include their study in the SR and the validation of data extraction. However, ultimately, the reviewer of the SR could write a short ethical report of the original studies. The last solution would be to make the ethical assessment in SRs a requisite of methodology.

Data extraction

Data extraction is defined by Buscemi, et al. (2006), as the process of writing out information obtained from the primary studies to a standardised format designed to represent suitable information pertaining to the research question. This stage of the SR is important because its results, conclusions, analysis and interpretation come from the data extracted.

Data analysis

Leech and Onwuegbuzie (2007), state that data analysis is a systematic search for meaning.

Qualitative Analysis:

The qualitative analysis involves organising and the examination of data that allows patterns, themes, relationships, explanations, interpretations, critiques and themes to be generated. The b-value of the DWI for example, will be used to form a theme as discussed by Grant, et al. (2014), and Wang, et al. (2014), that the higher the b-value, the better the diagnostic accuracy.

Quantitative Analysis

Descriptive statistics which uses variables like the PSA value will be used as recommended by The Open University. Inferential statistics will be applied at interventions (Lindsay, 2007), to look at the number of patients who will have a bp-MRI versus a DCE-mpMRI protocol for diagnosis.

Limitations

Lindsay (2007), writes that SRs can be limited by the design quality, their implementation and the type of population. In this proposal, the limitations may be the exclusion of non-English publications, literature over five years old and patients below the age of 50 although they may contain valuable information. Some limitations of SRs may include time, geographical and methodology. For the present study the one of the limitation is that it did not include any population from Asian countries so the data will not be a representative of that particular population.

Dissemination

Dissemination is defined by Begg and Berlin (1989), as a process of informing a target audience of research findings through various methods using planned strategies. Dissemination can be done by word of mouth to work colleagues, presentation at a staff meeting, press conferences to inform the general public and publication in a medical journal.

Implications for practice

In order for dissemination to prompt change and improve practice, Robertson-Malt (2014), recommends that the SR should be feasible, valid in terms of evidence, meaning, ethical values and efficiency. Feasibility will be ensured in a clinical setting, meaning that in this proposal, the bp-MRI may be implemented if proven to be a diagnostic tool. Meaningfulness would be achieved in this proposed study as it would eliminate the invasive cannulation and administration of GBCAs, affording patients a shorter scan time and minimising risks of allergic reactions. If this proposed SR is successful in highlighting the bp-MRI as a protocol of choice for PCa diagnosis, it would have achieved its intended effect.

References

Antwi, S.K. and Hamza, K., 2015. Qualitative and quantitative research paradigms in business research: A philosophical reflection. European Journal of Business and Management, 7(3), pp.217-225.

Leppäaho, T., Plakoyiannaki, E. and Dimitratos, P., 2016. The case study in family business: An analysis of current research practices and recommendations. Family Business Review, 29(2), pp.159-173.

Mingers, J., 2015. Helping business schools engage with real problems: The contribution of critical realism and systems thinking. European Journal of Operational Research, 242(1), pp.316-331.

Kohl, A., Rief, W. and Glombiewski, J.A., 2012. How effective are acceptance strategies? A meta-analytic review of experimental results. Journal of behavior therapy and experimental psychiatry, 43(4), pp.988-1001.