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High Sensitivity Troponin I Assay in High Risk Myocardial Infarction Patients

MODULE: Evidence Based Practice in Healthcare

Contents

  1. Assignment 1
  2. Assignment 4: Evidence Based Report
  3. The Problem
  4. Critical Appraisal of Literature
  5. Conclusions from Evidence
  6. Action Plan
  7. Personal Appraisal
  8. Relevance of EBP
  9. Bibliography

2. Assignment 1

 

Background to the problem

 

Myocardial infarction (MI) is the irreversible necrosis of cardiac muscle caused by a prolonged reduction in the available oxygen supply. Every year, approximately 1.5 million cases of MI occur in the United States. (E Medicine, 2018) The laboratory tests used in the diagnosis of MI include troponins (I & T), cardiac enzymes such as creatine kinase (CK) and lactate dehydrogenase (LDH), a full blood count and a lipid profile.

Currently, the use of the high sensitivity Troponin T Immunoassay developed by Roche is the primary laboratory test used to aid clinicians in the diagnosis and monitoring of acute myocardial infarction at University Hospital Limerick. The analysis of creatine kinase and lactate dehydrogenase is also used by clinicians to aid in the diagnosis of MI.

This assay is currently delivering in many key areas. The assay has lead to the earlier diagnosis of Non-ST-elevation myocardial infarction (NSTEMI). It also has a high prognostic value for cardiac events in patients with renal failure. (Roche, 2018) This assay is currently in use within the clinical biochemistry department at University Hospital Limerick. The numbers of test requests for Troponin T within the hospital have increased year on year.

Regarding the Troponin T assay currently in use at University Hospital Limerick, ‘flyers’ have been reported on a few occasions. Troponin flyers are false positive results. These occur when the initial troponin measurement reported a high result and the subsequent measurement reported a result that was within the normal range. These can occur due to interference from sample debris such as fibrin strands and activated platelets. For this reason, I believe it to be appropriate and relevant to investigate whether the high sensitivity Troponin I assay is a more sensitive and specific measurement of the severity of myocardial infarction in high risk patients when compared to the high sensitivity Troponin T assay. High risk patients include individuals with renal disease, high serum LDL levels and overweight individuals. I would also like to investigate if the high sensitivity Troponin I assay is subject to the same interferences.

 

 

 

 

 

 

 

 

 

 

 

 

 

The Question

 

‘’Investigating whether the high sensitivity Troponin I assay is a more sensitive and specific measurement of the severity of myocardial infarction in high risk patients when compared to the high sensitivity Troponin T assay and to investigate if the assay if subject to the same interferences’’.

Population: High risk patients including individuals with renal disease, high LDL levels and overweight individuals.

Intervention: Measurement of high sensitivity Troponin I

Comparator: Measurement of high sensitivity Troponin T

Outcome: Sensitive and specific measurement of the severity of myocardial infarction in high risk patients

 

 

Search Strategy

 

I used the 4S pyramid of knowledge that was described in lecture 4 as a guideline for finding the necessary articles that I required. The table seen below gives an outline of the various databases that I used for the workplace-based problem outlined earlier in the assignment.

I began my search using the Bandolier database. First, I used the Boolean operators (‘AND’) when entering the keywords ‘Troponin T’ and ‘Troponin I’. Next, I used the Boolean operators (‘AND’) and (‘OR’) when entering the keywords ‘Troponin T’ and ‘Troponin I’. Next, I used the Boolean operators (‘AND’) when entering the keywords ‘Troponin T’ and ‘Flyers’.

However, these terms outlined above gave me no relevant ‘hits’ for the terms listed above so this database was no longer used for this workplace – based problem.

Next, I used the BestBET’s database to help me in my search. I used the same search terms as the previous data base, but I also found no relevant hits from this database. I used the search term ‘Troponin I’ for this database and it gave me one relevant ‘hit’.

The next database that I used was the Cochrane Library database. I found that when I used the search term ‘Troponin T vs Troponin I’ the database gave me relevant ‘hits’. I returned to the two previous databases mentioned above and used the search term ‘Troponin T vs Troponin I’ but it still did not give me any relevant ‘hits’.

The next database that I used was Trip. I used the search terms ‘Troponin T vs ‘Troponin I’ AND ‘Laboratory’ and this returned two relevant hits.

The next database that I used was PubMed. When I used the search terms ‘Troponin T vs Troponin I’ the database gave me relevant ‘hits’. When the search terms ‘Troponin T vs Troponin I’ AND ‘Laboratory’ were used, no new relevant ‘hits’ were found.

Finally, I used Science Direct for my search but the articles that I found required a payment.

Order of search Database searched
1 Bandolier
2 Best Bets
3 Cochrane Library
4 Trip
5 PubMed
6 Science Direct

Figure 1: Databases Searched

 

Database Hits Excluded Hits Relevant Hits
Best Bets 1 0 1
Cochrane 63 58 5
Trip 179 177 2
PubMed 14 10 4

Figure 2: Results from Database Searches

 

 

Search Outcome

 

Author Date & Country Title of Paper Source of evidence
Jade R. Bringhurst USA, 2010 How useful are sensitive troponin I assays in early diagnosis of acute myocardial infarction? Michigan State University (Best BET’S)
Lee GR et al UK, 2014 Peri-operative troponin monitoring using a prototype high-sensitivity cardiac troponin I (hs-cTnI) assay: comparisons with hs-cTnT and contemporary cTnI assays Annals of Clinical Biochemistry (Cochrane)
James SK et al Sweden, 2004 A rapid troponin I assay is not optimal for determination of troponin status and prediction of subsequent cardiac events at suspicion of unstable coronary syndromes International Journal of Cardiology (Cochrane)
Kvisvik B et al USA, 2017 High-sensitivity troponin T vs I in acute coronary syndrome: prediction of significant coronary lesions and long-term prognosis American Association of Clinical Chemistry (Cochrane)
Snaedal S et al UK, 2015 High sensitive troponin T and troponin I three-month variation in prevalent haemodialysis and peritoneal dialysis patients Nephrology Dialysis Transplantation (Cochrane)
Heeschen C et al USA, 2000 Analytical and diagnostic performance of troponin assays in patients suspicious for acute coronary syndromes Stanford University School of Medicine (Cochrane)
Rubini Gimenez M et al Switzerland, 2014 Direct comparison of high-sensitivity-cardiac troponin I vs. T for the early diagnosis of acute myocardial infarction. Department of Cardiology, University Hospital Basel (Trip)
Tanglay Y et al Switzerland, 2015 Incremental value of a single high-sensitivity cardiac troponin I measurement to rule out myocardial ischemia. Department Of Cardiology, University Hospital Basel (Trip)
Apple FS et al USA, 2017 Cardiac Troponin Assays: Guide to Understanding Analytical Characteristics and Their Impact on Clinical Care. Department of Laboratory Medicine and Pathology, Hennepin County Medical Centre, and University of Minnesota, Minneapolis, MN (PubMed)
Parikh RH et al USA, 2015 Use and interpretation of high sensitivity cardiac troponins in patients with chronic kidney disease with and without acute myocardial infarction Department of Medicine, Division of Cardiovascular Medicine, University of Maryland School of Medicine, Baltimore, MD, 21201, USA (PubMed)
Twerenbold R et al Switzerland, 2012 High-sensitive troponin T measurements: what do we gain and what are the challenges? Department of Cardiology, University Hospital Basel (PubMed)
Apple FS et al USA, 2012 Analytical characteristics of high-sensitivity cardiac troponin assays. Hennepin County Medical Centre, Minneapolis, MN 55415, USA (PubMed)

Figure 3: Database Searches

 

 

Reflection

 

The field of evidence – based practice is an area where I would have little to no knowledge in prior to the commencement of this module. At the beginning of this assignment, I was very apprehensive about taking on this task as my first database search gave me no relevant ‘hits’ but after continuing to the next few databases such as Cochrane, PubMed and Trip, I was relieved that I was able to find relevant papers.

I feel that I could possibly have used more filters in my database searches and I also feel like I could have been more prepared before beginning my database search, but this was not possible due to time constraints. I also feel that I may have to refine or perhaps even amend my question before progressing on to assignment four.

After using many different databases, I found some to be much more useful than others. PubMed and Cochrane generated many more relevant ‘hit’s than Best Bets. Searching through so many of these papers has been extremely time consuming and frustrating but I believe that I have gathered some very interesting and relevant papers.

After completing this assignment, I feel that I have learned new skills relating to the searching of databases and the retrieval of journals and articles. I believe that these new skills will be of great benefit to me for the remainder of the masters.

 

 

References

 

Roche. (2018). Elecsys® Troponin T high sensitive (TnT-hs). [online] Available at: http://www.cobas.com/home/product/clinical-and-immunochemistry-testing/elecsys-troponin-t-hs-tnt-hs.html [Accessed 25 Feb. 2018].

E Medicine. (2018). Myocardial Infarction: Practice Essentials, Background, Definitions. Available online at: https://emedicine.medscape.com/article/155919-overview [Accessed 25 Feb. 2018].

3. Assignment 4: Evidence Based Report

 

4. The Problem

From assignment 1, I submitted the following question: ‘’Is the high sensitivity Troponin I assay a more sensitive and specific measurement of the severity of myocardial infarction in high risk patients when compared to the high sensitivity Troponin T assay and to investigate if the assay if subject to the same interferences?’’.

I believe that I formulated an answerable question which provided the basis to perform an online literature search using the relevant scientific databases.  As I have progressed in this module, I feel I have developed an indebt knowledge of evidence-based practice (EBP) through the detailed lecture notes and assessments. However, after significant reflection on assignment 1, there were some aspects that I could have improved on.

Following feedback from assignment 1, I have made amendments to both the structure and PICO elements of my question. The amended question is outlined below:

‘’Is the high sensitivity Troponin I assay a more sensitive and specific assay for the diagnosis of myocardial infarction compared to the high sensitivity Troponin T assay?’’

The amended PICO elements are outlined below:

Population: Suspected myocardial infarction patients

Intervention: Measurement of high sensitivity Troponin I

Comparator: Measurement of high sensitivity Troponin T

Outcome: A more sensitive and specific assay for the diagnosis of myocardial infarction

My initial search strategy did not involve the use of the correct Boolean operators and it also did not involve the use of any MeSH terms. These thoughts have been supported from the feedback that I received from assignment 1. I believe that it is very important to ensure that all the hits that are produced are relevant to the question being submitted.

My new primary search strategy is as follows: ‘Troponin T’ AND ‘Troponin I’ AND ‘Laboratory measurement’ AND ‘fl*er’ AND ‘myocardial infarction’. This new search strategy involved the use of the MeSH term ‘myocardial infarction’. By tweaking my search strategy, I generated a smaller number of relevant papers. Another lesson that I learned from my analysis of assignment 1, was to only include papers that were fully accessible and had a relevant method section.

 

 

5. Critical appraisal of literature

I will critically appraise 5 scientific papers.

Please note: Following amendment of the question and search strategy, I have found two new papers that I will include in the critical appraisal section. Their details can be seen below.

Author Date & Country Title of Paper Source of Evidence
Islam Y Elgendy & Carl J Pepine USA, 2018 High sensitivity cardiac troponin T and I and risk stratification of patients with stable CHD: Is it time to incorporate this in routine clinical practice? International Journal of Cardiology
Twerenbold et al Switzerland, 2017 Early diagnosis of acute myocardial infarction in patients with mild elevations of cardiac troponin Clinical Research in Cardiology

I have decided to reject the remaining papers generated from the search that I performed in assignment 1 for the reasons outlined in the table below

Author Title of paper Reason for exclusion
Jade R. Bringhurst How useful are sensitive troponin I assays in early diagnosis of acute myocardial infarction? Does not mention high sensitivity Troponin T or a comparison to Troponin I
Lee GR et al Peri-operative troponin monitoring using a prototype high-sensitivity cardiac troponin I (hs-cTnI) assay: comparisons with hs-cTnT and contemporary cTnI assays Feedback from assignment 1 mentioned little relevance when question is related to myocardial infarction
James SK et al A rapid troponin I assay is not optimal for determination of troponin status and prediction of subsequent cardiac events at suspicion of unstable coronary syndromes Unable to access full paper online
Snaedal S et al High sensitive troponin T and troponin I three-month variation in prevalent haemodialysis and peritoneal dialysis patients Population specific to haemodialysis and peritoneal dialysis patients
Heeschen C et al Analytical and diagnostic performance of troponin assays in patients suspicious for acute coronary syndromes Unable to access full paper online
Tanglay Y et al Incremental value of a single high-sensitivity cardiac troponin I measurement to rule out myocardial ischemia. Paper not relevant to proposed question
Parikh RH et al Use and interpretation of high sensitivity cardiac troponins in patients with chronic kidney disease with and without acute myocardial infarction Unable to access full paper online
Twerenbold R et al High-sensitive troponin T measurements: what do we gain and what are the challenges? No new information provided
Apple FS et al Analytical characteristics of high-sensitivity cardiac troponin assays. No new information provided

Figure 1

 

 

 

Paper 1

Title: Direct comparison of high-sensitivity-cardiac troponin I vs. T for the early diagnosis of acute myocardial infarction

Authors: Maria Rubini Gimenez, Raphael Twerenbold, Tobias Reichlin, Karin Wildi, Philip Haaf, Miriam Schaefer, Christa Zellweger, Berit Moehring, Fabio Stallone, Seoung Mann Sou, Mira Mueller, Kris Denhaerynck, Tamina Mosimann, Miriam Reiter, Bernadette Meller, Michael Freese, Claudia Stelzig, Irina Klimmeck, Janine Voegele, Beate Hartmann, Katharina Rentsch, Stefan Osswald, Christian Mueller, European Heart Journal, Volume 35, Issue 34, 7 September 2014, Pages 2303–2311.

Overview: The objective of this study was to directly compare the ability of both high sensitivity Troponin I & T for the early diagnosis of acute myocardial infarction

Level of evidence: Level 1b (diagnostic)

Strengths:

  • Author has clearly outlined the inclusion & exclusion criteria that was used.
  • Large sample size (2226 patients participated)
  • A routine clinical assessment and baseline troponin measurements were performed on all patients
  • The author has clearly outlined both the laboratory and statistical methods that were used
  • Study findings clearly outlined in diagrams and graphs
  • The authors study design is easy to follow

 

Weaknesses:

  • This study was prospective and observational. Therefore, the clinical benefit associated with the clinical use of either hs-cTnI or hs-cTnT cannot be precisely determined.
  • As patients with terminal kidney failure were excluded from this study, the diagnostic and prognostic performance of the assays in these patients cannot be determined.

 

Conclusion: I will include this paper in the decision-making process. This paper is extremely relevant as it directly compares the ability of both high sensitivity Troponin T & I for the early diagnosis of acute myocardial infarction. This direct comparison highlighted small but potentially important differences between the performance of the high sensitivity Troponin I assay and the high sensitivity Troponin T assay. This could help to further improve the clinical use of cardiac troponins in the management of patients presenting with suspected acute myocardial infarction.

ACCEPT

 

 

 

Paper 2

Title: High-Sensitivity Troponin T vs I in Acute Coronary Syndrome: Prediction of Significant Coronary Lesions and Long-term Prognosis

Authors: Brede Kvisvik, Lars Mørkrid, Helge Røsjø, Milada Cvancarova, Alexander D. Rowe, Christian Eek, Bjørn Bendz, Thor Edvardsen, Jørgen Gravning. Clinical Chemistry, 63(2), pp.552-562.

Overview: This study involved the direct comparison of both high sensitivity Troponin T & I assays in acute coronary syndromes and their ability to predict the development of significant coronary lesions and the long-term prognosis of these patients.

Level of evidence: Level 1b (diagnostic)

Strengths:

  • The author provides a clear and detailed description of both the laboratory and statistical methods that were used in this study
  • One investigator analysed the ECG results with no knowledge of the patients Troponin concentration at the time of the ECG examination
  • The assay manufacturers had no role in the study design which aided in the elimination of manufacturer bias.
  • The author has clearly outlined both the inclusion and exclusion criteria for this study

Weaknesses:

  • There is a much smaller sample size (458) when compared to paper 1 (2226)
  • The results of this study were based on a single measurement of cardiac troponin after admittance to a coronary care centre. The possibility that either earlier or serial sampling could have affected the results obtained cannot be excluded

Conclusion: I will include this paper in the decision-making process. This paper is extremely relevant to the proposed question as it directly compares both troponin assays and their ability to predict the development of significant coronary lesions. When a single measurement of both assays was performed, the accuracies of both were found to be similar. A small but statistically significant difference in prognostic accuracy between the two assays, in favour of Troponin T was detected. The findings from this study have shown that both Troponin assays display a similar ability to detect significant coronary lesions. In this patient group, the data has suggested that the observed differences between both assays have biological rather than analytical explanations. Future studies are required to further explore the relevance of the differences between the 2 high-sensitivity troponin assays used in cardiovascular disease.

ACCEPT

 

Paper 3

Title: Cardiac Troponin Assays: Guide to Understanding Analytical Characteristics and Their Impact on Clinical Care

Authors: Apple, F., Sandoval, Y., Jaffe, A. and Ordonez-Llanos, J. (2016). Clinical Chemistry, 63(1), pp.73-81.

Overview: This article highlights important educational information regarding the high sensitivity troponin T & I assays and their 99th percentile upper reference limits. It also addresses the high sensitivity assays that are used to measure low concentration of troponin.

Level of evidence: Level 1a (diagnostic)

Strengths:

  • The author provides a clear and detailed description of the laboratory methods that were used in this study
  • The author provides a clear and detailed description of the statistical methods that were used in this study
  • The author has clearly outlined the inclusion/exclusion criteria for defining healthy reference populations for determining the 99th percentile
  • The author has provided very informative figures showing all the data that has been collected
  • The authors findings are represented clearly
  • The authors study design is easy to follow

 

Weaknesses:

  • The authors search strategy is not clearly outlined

Conclusion: I will include this paper in the decision-making process. This paper is relevant to the proposed question as it details both high sensitivity Troponin assays currently in use worldwide. It clearly outlines the biological variability of both these assays and, explains clearly how to characterise these assays using clinical criteria. The paper also clearly outlines the implementation of a new troponin assay in the clinical laboratory. I think this is very relevant to the proposed question if a new troponin assay were to be introduced into the clinical biochemistry laboratory at University Hospital Limerick.

ACCEPT

 

 

Paper 4

Title: High sensitivity cardiac troponin T and I and risk stratification of patients with stable CHD: Is it time to incorporate this in routine clinical practice?

Authors: Islam Y Elgendy & Carl J Pepine (2018). International Journal of Cardiology, 250, pp.266-267.

Overview: The objective of this paper was to outline the use of both high sensitivity Troponin T & I in the risk stratification of patients with stable coronary heart disease.

Level of evidence: Level 1a (diagnostic)

Strengths:

  • The KAROLA Study that compared both troponin assays had a large sample size of 1068 stable coronary heart disease patients.
  • The author has clearly outlined both the inclusion and exclusion criteria
  • The KAROLA Study was a long – term study. It took place over a period of 13 years.

Weaknesses:

  • This paper contains referral bias. The study cohort was derived from a population who underwent cardiac rehabilitation procedures.
  • The paper only reviewed 5 studies

Conclusion: Overall, I am happy with the findings of this paper, but I will not include this paper in my decision-making process. The paper does support the idea that abnormal levels of troponin T & I are associated with worse outcomes in patients with stable coronary heart disease, but the paper does not outline comparisons between both troponin assays. It also does not provide evidence on which troponin assay is more sensitive and specific for the early diagnosis of myocardial infarction.

REJECT

 

 

Paper 5

Title: Early diagnosis of acute myocardial infarction in patients with mild elevations of cardiac troponin

Authors: Jasper Boeddinghaus, Tobias Reichlin, Thomas Nestelberger, Raphael Twerenbold, Yvette Meili, Karin Wildi, Petra Hillinger, Maria Rubini Giménez, Janosch Cupa, Lukas Schumacher, Marie Schubera, Patrick Badertscher, Sydney Corbière, Karin Grimm, Christian Puelacher, Zaid Sabti, Dayana Flores Widmer, Nicolas Schaerli, Nikola Kozhuharov, Samyut Shrestha, Tobias Bürge, Patrick Mächler, Michael Büchi, Katharina Rentsch, Òscar Miró, Beatriz López, F. Javier Martin-Sanchez, Esther Rodriguez-Adrada, Beata Morawiec, Damian Kawecki, Eva Ganovská, Jiri Parenica, Jens Lohrmann, Andreas Buser, Dagmar I. Keller, Stefan Osswald, Christian Mueller. Clinical Research in Cardiology. June 2017, Volume 106, Issue 6, pp 457–467

Overview: This paper involved the measurement of copeptin, troponin T and troponin I to assess which of these laboratory tests are better suited for the early diagnosis of acute myocardial infarction.

Level of evidence: Level 1b (diagnostic)

Strengths:

  • The author has clearly defined both the inclusion and exclusion criteria
  • The author has clearly defined both the laboratory and statistical methods used
  • Large sample size (1356 patients selected from a total of 1960 patients).

 

Weaknessess:

  • This study was a secondary analysis from a large ongoing multicentre study.
  • The adjudication was blinded to copeptin and troponin I measurements but not to troponin T measurements. Therefore, this lead to a small bias in favour of changes in troponin T

Conclusion: I will include this paper in the decision – making process. This paper is extremely relevant to the question that I have put forward.

ACCEPT

6. Conclusions from evidence

The objective for this EBP investigation was to determine whether the high sensitivity Troponin I assay is a more sensitive and specific assay for the diagnosis of myocardial infarction when compared to the high sensitivity Troponin T assay.

Following the appraisal of the relevant literature, I will now attempt to answer this question.

From the papers that I have critically appraised, I think an answer to this question has been made. I believe that the high sensitivity Troponin I assay is not a more sensitive and specific assay for the early diagnosis of myocardial infarction when compared to the high sensitivity troponin T assay.

Both troponin assays provide high diagnostic accuracy for Non – ST – elevation myocardial infarction (NSTEMI). The diagnostic accuracy at presentation for both assays was found to be similar (Rubini Gimenez et al., 2013). It was also found that the time from symptom onset may impact on the respective diagnostic superiority of either assay over the other (Rubini Gimenez et al., 2013). The high sensitivity troponin I assay was found to be superior in early presenters, while the high sensitivity troponin T assay seemed to be superior in late presenters. Although early presenters can be assumed to receive more benefit from early revascularisation, it is not clear whether the magnitude of the difference is enough to achieve a clinical relevance (Rubini Gimenez et al., 2013).

Also, during the serial sampling of patients for both troponin I and T, the diagnostic accuracy of both assays increased (Rubini Gimenez et al., 2013).

The prognostic accuracy to predict non-fatal acute myocardial infarction during the 24-month follow-up among patients in the no-NSTEMI group was low for both troponin assays. Both troponin assays showed high diagnostic and prognostic accuracy (Rubini Gimenez et al., 2013). The comparison between both highlighted small but potentially important differences between both assay’s performance. These findings may help to improve the clinical use of both troponin assays for the early detection and diagnosis of acute myocardial infarction (Rubini Gimenez et al., 2013).

It was also found that a small but statistically significant difference in prognostic accuracy exists between the two assays, in favour of Troponin T. (Kvisvik et al., 2016). The findings from this study have shown that both Troponin assays display a similar ability to detect significant coronary lesions (Kvisvik et al., 2016).

The findings have also outlined the biological variability of both these assays and, explains clearly how to characterise these assays using clinical criteria (Apple and Collinson, 2014). The literature that I have found has clearly outlined the implementation of a new troponin assay into a clinical laboratory. If a new troponin assay were to be introduced into the clinical biochemistry laboratory at University Hospital Limerick, this information would be extremely relevant.

I would assign a grade A of recommendation for the EBP research. I have only included papers that offer the highest level of evidence (level 1).

 

 

7. Action Plan

At present, it is evident from the researched literature that a change in practice regarding troponin assays within the clinical biochemistry laboratory at University Hospital Limerick may not be required. The laboratory currently operates the high sensitivity troponin T assay developed by Roche. At present, the laboratory does not operate an analyser that can run the high sensitivity troponin I assay developed by Abbott Diagnostics.

Soon, the department hopes to introduce a complete new set of analysers pending the granting of a service contract to the successful company. If Abbott Diagnostics is awarded this contract, the high sensitivity troponin I assay will need to be introduced into the laboratory. Many different factors will need to be assessed prior to the implementation of the assay.

Cost is probably the key factor in controlling the implementation of a new assay. Prior to the implementation of a universal change throughout the hospital, it is important to estimate the costs involved. Once implemented, this assay would be readily available to all clinicians. However, it would require specific calibrators and controls.

Once the contract is awarded to the successful company, the timely and efficient introduction of the new assay would be a top priority. Another factor that would affect the implementation of the new assay would be the requirement for the training of laboratory staff to operate the new troponin assay. The introduction of a new assay would also require a medical scientist to validate this new assay on top of an already very heavy workload. The alleviate the pressure of this, the successful company could perhaps validate the new assay themselves.

Should Abbott Diagnostics be awarded the contract, the implementation plan for the high sensitivity Troponin I assay is outlined below:

  • I will discuss the findings of my EBP question with the chief medical scientist, senior of the endocrinology bench and our consultant biochemist.
  • As discussed above, I will identify the main barriers that may affect the timely and efficient introduction of this assay into the laboratory.
  • Once all the barriers to implementation are identified, I plan to deliver a short presentation to my colleagues. The main purpose of this presentation will be to explain how to introduce this assay in an efficient and timely manner.
  • The next step in the plan would be to source the relevant assay calibrators and controls.
  • Following this, the assay would need to be validated.
  • Following assay validation, medical scientists would need to be trained and a new standard operating procedure (SOP) would need to be written up.

 

8. Personal Appraisal

Overall, I have found the evidence-based practice module extremely challenging and at times, quite difficult. Looking at the module in its entirety, I feel that I haven’t quite grasped what the module is trying to get across. Perhaps, the primary reason for this was that it was my first time encountering this type of module. I have searched online databases for my undergraduate degree but without using the techniques that I encountered in this module. This module really showed me that scientific papers can have many flaws, and these can be highlighted if the correct EBP techniques are used. After completion of this module, I feel that I have made many mistakes, but I also feel that I have learned a lot of new techniques that I will use for the remaining of my masters.

I think the most challenging part of this assignment was deciding on a relevant question. After reflecting on this, I believe that I should have looked for advice from a senior medical scientist at work or sent a message through blackboard to one of the course lecturers. In future, If I have any question or doubt relating to a module, I will immediately email the module e – tutor.

Another barrier that I encountered during the completion of this assignment was the lack of open access articles available online. The searches that I carried out produced articles that were relevant to the proposed question but on researching these articles, I found that some of the articles only had the abstract available for me to read. In future literature searches, I plan to include a filter that will exclude articles that do not have the full text available.

Also, I feel that I really need to improve my documenting skills following this assignment. During my searches of the different databases, I failed to keep a record of the key search terms. This lead to me repeating the search practices for the different databases which I felt was very time consuming. An extract from the diary that I kept can be seen below:

‘’After searching the first few databases, I realised that I was not keeping a record of the key search terms. This practice is really time consuming so for the remaining databases, I need to keep a clear record of the search terms that I use’’

After reflecting on this mistake, I plan to ensure that all future searches for assignments will be clearly documented.

For assignment 4, I was really dreading the thought of critically appraising the articles that I had found. This was primarily due to my complete lack of experience in this area. I feel that I wasted a lot of time reading through the full articles numerous times when really, I should have primarily focused on the materials and methods sections. After completing this module, I feel that my appraisal skills have improved but I still have a lot to learn in this area.

Future professional development

Following this assignment, I think that I have improved my documenting skills. I also think that I have become more vocally interactive with my work colleagues. I think that I have learned new research skills that will be applicable for the future modules that I take during the masters. If a new assay were to be introduced in work, I feel that I could contribute to this process. After completing this module, I feel that I would be able to apply an evidence – based approach to challenges that may arise in the workplace.

9. Relevance of EBP

After completing this module, I have learned that evidence-based practice is an important process. It paves the way for the introduction of the most up to date and technically sound techniques into the clinical laboratory setting. Evidence based practice is not just confined to the clinical laboratory setting. It has a major role to play in the wider healthcare environment.

Evidence based practice is based on the ‘best evidence available’ and it is ‘patient centred’. This means that the clinician/practitioner does not rely purely on his/her own evidence but makes decisions on reliable research where possible. A large proportion of clinical decisions are not made based on the ‘best evidence available’.

The process of evidence – based practice is user friendly. The process involves the generation of a question, an evidence search, appraisal of the evidence found and the implementation of the evidence into clinical practice. Usually, the conclusions from these processes are focused around patient care. These practices can lead to the constant evolution of healthcare practices thus leading to the main goal which is improved patient care.

With regards to the evolution of clinical laboratories, we can take University Hospital Limerick as an example. A ‘blood sciences project’ is currently underway at University Hospital Limerick. This project will involve the introduction of pre – analytical, analytical and post – analytical laboratory instrumentation within the department. The project will also involve the introduction of new laboratory methods. These processes will require an evidence-based approach.

After careful discussion with my work colleagues, it was interesting to see that many of them are unfamiliar with the process of performing an EBP investigation. I plan to encourage them to read up more on how to perform such an investigation.

I believe that the process of EBP can be extended to all areas of clinical practice. Ultimately, this will lead to improved patient care and a more efficient health service.

WORD COUNT: 3945

 

10.Bibliography

Apple, F. and Collinson, P. (2014). Analytical Characteristics of High-Sensitivity Cardiac Troponin Assays. Laboratory Medicine Online, [online] 4(1), p.55. Available at: https://www.ncbi.nlm.nih.gov/pubmed/21965555 [Accessed 16 Apr. 2018].

Apple, F., Sandoval, Y., Jaffe, A. and Ordonez-Llanos, J. (2016). Cardiac Troponin Assays: Guide to Understanding Analytical Characteristics and Their Impact on Clinical Care. Clinical Chemistry, [online] 63(1), pp.73-81. Available at: https://www.ncbi.nlm.nih.gov/pubmed/28062612 [Accessed 16 Apr. 2018].

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