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Critical Review Evidence.

September 21, 2015 0 Comment

Critical Review Evidence.

PART 1: Completed PICO Worksheet
My situation of uncertainty of best practice related to a:
** Quantitative type of question: I have completed the PICO question ?

1. Use the following categories to help define your problem and what you are looking at in simple terms
PICO: Patient/Problem, Intervention, Comparison, and Outcome. (Quantitative situation)
(remember to use  your readings to help you if you are unsure)

Patient/Problem:  Adults patients with hypertension
Intervention:  Effectiveness of Thiazides diuretics
Comparison: Alternative pharmacotherapy with CoQ10
Outcome: Clinically significant reduction of bloodpressure

2. Now use these terms from the question above to create your PICO research question so that you have a clear purpose for your search:
Inadult patients with hypertension, is the alternative pharmacotherapy with CoQ10 more effective in clinically significantly lowering blood pressure compared to the use of conventional first line treatment with thiazides diuretics?

3. What type of question do you think this PICO answers?
It answers questions relating to Therapy (efficacy)
4. The table below will help you to think of the other terms that you might also like to look up when searching for evidence to help you answer your question – this is part of basic planning for a research search.


Adults patients with hypertension


Thiazides diuretics

(not commonly used in actual database search strategy)

Coenzyme Q10
(not commonly used in actual database search strategy)

Decrease blood pressure

5. Is there a particular group of people that you want to look at? List here any inclusion criteria you might use to refine your search if you have too many papers:

Gender:  ALL                                                                    Age Range: ALL

Publication Dates: ALL                                                   Language: English

6. What kind of study do you think would best answer your question? Select here which type of article you might want to access. You can also use these to refine your search if you have a lot of papers.
?  Systematic Review
?  Randomized Controlled Trial (RCT)

Systematic Search Plan (this is what we call a Search Strategy)
7. Now that you have decided on WHAT you will be searching, you need to put down a plan of HOW you will search for your articles. This helps you and others to see how you got your evidence and how you made sure you got the best evidence to help you decide on your clinical action.
?    Using the PICO terms in your table, enter each term in a row (group them together under the PICO categories).
?    The next step is to combine similar terms using ‘OR’ so that you have all the papers on the same topic together
?    The final step is to find papers which only talk about both the population AND the intervention. To do this you use ‘AND’ in the database.

Key terms:
1    Hypertension
2    Thiazides diuretics
3    Diuretics
4    Anti hypertensive medication
5    2 OR 3 OR 4
6    CoQ10
7    Coenzyme Q10
8    Alternative medication
9    Alternate medication
10    Complementary medication
11    6 OR 7 OR 8 OR 9 OR 10
12    Blood pressure
13    1 OR 12
14    5 AND 11 AND 13
15    Therapeutics
16    5 OR 15
17    14 AND 16

8. The final step is to paste in a picture (screenshot/screen grab) of the search that you did in the database. The picture has to be readable!!!

Evidence Selection and Critical Appraisal using CASP Objectives

Systematic Review Appraisal Tool
Section A: Are the results of the review valid?

In adult patients with hypertension, is the alternative pharmacotherapy with CoQ10 more effective in clinically significantly lowering blood pressure compared to the use of conventional first line treatment with thiazides diuretics?

Rosenfeldt, F. L., Haas, S. J., Krum, H., Hadj, A., Ng, K., Leong, J., & Watts, G. F. (2007). Coenzyme Q10 in the treatment of hypertension: a meta-analysis of the clinical trials. Journal of human hypertension, 21(4), 297-306

Did the review address a clearly focused issue?
The main objective of the study was to make an assessment of overall efficacy and consistency of therapeutic action and incidence of side effects and to make a review of published trials of coenzyme Q10 for hypertension. Hypertension poses an increase in the burden of disease globally. The article starts by explaining the rationale behind conducting the study which makes it easier for readers to orient themselves (Parahoo 2014). The researchers indicate that hypertension has increased its threat as a global disease with the main management being the use of various medications. They point out that though they have effectiveness in the reduction of blood pressure, there are also various undesirable side effects like cardiac or renal dysfunction, depression and coughs.
Did the authors look for the right type of papers?
To introduce their study, they note the evidence of Coenzyme Q10 being used as therapeutic treatment in lowering blood pressure and improving glycaemic control. A wide range of recent literature is used by the researchers in their literature review. This is supported by previous literature on management of hypertension in clinical trials by use of CoQ10. In this article, Rosenfeldt et al. (2007) conducted a qualitative study with a meta-analysis in 12 clinical trials of 362 patients from three randomized control trials, eight open label studies and one crossover study. The main intervention plan for all the patients were the use of CoQ10 in the treatment of hypertension and the expected results were that there would be no adverse side effects when using CoQ10. Therefore, through this introduction, the research can be termed as valid as it considers the use of CoQ10 as an alternative pharmacotherapy in the treatment of hypertension to lower blood pressure.
Do you think the important, relevant studies were included?
The authors also looked for the right type of papers which considered all the aspects required in the meta-analysis. In making a review of published trials, the researchers began by carefully searching literature for identification of clinical trials of CoQ10 in hypertension therapy. Using an Evidence Based Medicine review, they included a variety of databases like American College of Physicians Journal Club, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, Embase, Medline search (1966-2005), and PubMed (1966-2005). A consultation of the bibliographies of the selected articles was done and the search strategy including significant key words that had a relation to the trial design was utilized (including random allocation, double blind, placebo controlled, and randomized clinical trial), then cross-linked with terms that have a reference to CoQ10 and other terms like blood pressure and hypertension. The studies found address the review question adequately as all the key terms in the question are included in the search and thus, in the studies found. Therefore, the studies included were relevant to the study objectives.
Did the review’s authors do enough to assess the quality of the included studies?
In consideration of the rigour of the studies, the authors made a thorough analysis of the studies. This assessment was used to find the quality of the studies included. Using a meta-analysis, the results were pooled in the STATA v.8.2 software and the Cohen method of meta-analysis for weighted mean difference with regard to the continuous variables. These were presented as effect size with confidence limits of 95%. Each individual study is assigned a relative weight by the STATA in accordance to its contribution in the performance of the meta-analysis based on the treatment group’s size and the confidence level’s preciseness.  The same weighting technique of inverse variance was used by Rosenfeldt et al. (2007), to calculate the before and after treatment mean values. Thus, the researchers used an appropriate study design by using a qualitative study. In the evaluation of interventions, they made sure to find randomized control trials. These trials would provide information in the determination of the existence of a cause-effect relation between treatment and outcome (Sibbald& Roland 1998). In making an assessment of overall efficacy and consistency of therapeutic action and incidence of side effects, they ensured that they effectively used the randomized controlled trials
If the results of the review have been combined, was it reasonable to do so?
There were12 studies identified and reporting a total of 362 patients as CoQ10 was used in their hypertension therapy. They consisted of three randomized controlled clinical trials, eight open label observational studies with no control group and one crossover study. Due to the variety in methodology, Rosenfeldt et al. (2007) opted to do a separate analysis for the three groups. It was reasonable for the researchers to combine the related studies and then grouping them according to their methodologies. This would make it easier to present their results for the trials.
There was a similarity of the results from study to study as indicated by the authors where the blood pressure of the patients decreased in each of them. There were similar results in the prospective randomized studies and the crossover study (Rosenfeldt et al. 2007). The open label observational studies also indicated a similar result. In all the three types of study, the results were similar showing decreases in the diastolic blood pressure in a range of 8 mm to 10 mm Hg and in the systolic blood pressure in a range of 11 mm to 17 mm Hg (Rosenfeldt et al. 2007). These results were justified and supported with data summary tables, which were easy to read and understand (Parahoo 2014). Furthermore, all the 12 studies indicated minimal side effects with one of the trials reporting a gastrointestinal side effect occurring at 37% in 30 of the patients treated with CoQ10 which had no significant difference with the placebo group rate
(p=0.29, 21%) (Singh et al.  1999). One other trial gave a report of three out of 23 patients , a 13% side effect incidence, with each having headache, flatulence and nausea (Burke et al. 2001). An absence of side effects was reported in two other trials (Digiesi et al. 1990; Folkers et al. 1981) and no comments were made on the other eight trials remaining, thus no significance.

Section B: What are the results?
What are the overall results of the review?
The overall results indicate that there is a similarity in all the studies with the blood pressure decreases being significant ranging from 7 mm to 16 mm Hg diastolic and from 10 mm to 21 mm Hg systolic with the randomized studies having a similar magnitude. Thus, across all the studies, the meta-analysis presented by Rosenfeldt et al. (2007) found that there was a lowering effect of blood pressure when using CoQ10 in hypertension treatment.

How precise was the estimate of the treatment effect?
It was very precise.
The consistency had a similarity with the serious adverse effects being absent in the therapy. The results were expressed in a range of the Hg (both diastolic and systolic) for the patients. The estimate of treatment effect was precise as the authors indicate the confidence levels with 95% confidence level being used in the presentation of results.
Section C: Will the results help locally?
Can the results be applied to the local population?
There is a possibility of the results being applied to the local population. This is because the population of patients covered by the review varies with respect to age, comorbidities and underlying disease and thus is inclusive of adult patients that are the main concern in my study. The local setting may be a little different since some of the studies are too old with one even being done 30 years ago. Some of the open label studies also have no conformation to modern standards of clinical trials which will be in use in my study. The duration of therapy and dosage used are also varied. When drugs are administered into the body system, there are various physiological implications that may occur, depending on its functional mechanism
(Gordon et al. 2013). Though the studies prove that there is success in the use of CoQ10 in treatment of hypertension, the authors also brought to light that in the current era, its use is complicated by the wide use of statins in lowering serum cholesterol. This inhibits its working mechanism. Furthermore, there is no standard dosage for use as the different patients in the studies were variable and the CoQ10 administered by a consideration of the therapeutic blood level of the patient.
Were all important outcomes considered?
All the important outcomes of the studies were considered by the authors though there was no inclusion of the assessment of major events associated with cardiac events like stroke, heart attack and death. They would have been significant used in detecting the end points. The discussion by the researchers proved to be clear, comprehensible and justifiable. The results were summarised and compared with the existing literature and previous studies with acknowledgement of the authors’ limitations with no interests declared.
Are the benefits worth the harms and costs?
The authors note that the research was not perfect as it had some limitations. In the first place, the patient populations in the meta-analysis had differences depending on the commodities, age and underlying disease. There were also exclusion criteria that were strict in the more recent studies but not in the older ones. Furthermore, the standards of modern clinical trials were not available for some of the trials and thus, did not conform to them. The observational studies were also uncontrolled where the patients in the trials were not based on a cut off. Thus, interpretation of the trials needed caution. Additionally, the major events associated with cardiac like death, stroke or heart attack were not critically evaluated in the assessment. Although legally it is a practitioner’s duty to save lives by medical care (Daley et al. 2013), they should also follow ethical principles where they present maximum benefits to their patients.
Though the inference of lowering blood pressure needs to be significant, it needs relevance for patients with non-adverse safety profiles. Being a meta-analysis, this research faces the risk of favouring the reporting of positive studies and for the neutral or negative ones, there is non-reporting. However, having the knowledge of this, the authors note that that the meta-analysis is in conformation to recommendations of careful search of literature making the results available.
In conclusion, the authors successfully conducted a meta-analysis where they found that in hypertensive patients, Coenzyme Q10 potentially lowers both the diastolic pressure by up to 10 mm Hg and systolic blood pressure by up to 17 mm Hg with no side effects of significance. Thus, they note that there is a possibility of conducting a prospective randomized trial of CoQ10 for a validation of the meta-analysis results.  This study has conclusively demonstrated the effectiveness of using CoQ10 in the management of hypertensive patients without significant side effects in comparison to the conventional medications. The limitations of this meta-analysis were based on the populations of patients, old studies not conforming to modern clinical trial standards, and publication bias.

PART 3:  Short answers following appraisal

1.    What are some barriers and enablers to you implementing evidence based practice in your workplace?
In clinical practice, there are successful strategies to change health care professionals’ practice in the improvement of health care and others are unsuccessful. This occurs due to a variety of barriers to and enablers of change where they occur at different times and in different settings. The identification of the barriers and enablers to change is significant as a step of planning on closing the gaps of evidence practice since change can occur when there are specific choices of strategies in making use of the enablers and addressing the barriers identified (Shaw et al. 2005).
Across different levels of clinical practice and health care like in Evidence Based Medicine,, there are various barriers and enablers to change.  Though the strategies of change may have to be multi-sectorial or multidimensional, there needs to be a comprehensive approach attempting to address all barriers in all settings and in all sectors which can sometimes be unaffordable or unfeasible (Grol&Wensing 2004). The analysis of barriers and enablers can support in the planning of programs of implementation in deciding on where the efforts can be focused with tailored interventions that would address the particular barriers and ensure the use of particular enablers (Hulscher et al. 2001).
In the implementation of evidence based practice in my workplace, there are some barriers and enablers. First is credibility where the perception of clinicians on the convenience of the practice may be a barrier or enabler. Guidelines in place should determine and recommend the change in practice (Rainbird et al. 2006). Secondly, there may be a lack of motivation of the clinicians to change even for individual professionals. Another barrier or enabler is based on the patient in terms of skills, compliance and attitude where the patient may have expectations of a variety of services and not others. In the context of the organization, there are barriers and enablers of staff, structures, care processes, resources and capacities. These can all be in terms of poor communication and paperwork inhibiting the provision of proper care. Socially, there may be an encouragement by local leaders on the use of the most common care or those that have not been proven as effective (Rainbird et al. 2006). Economically and politically, there are policies, regulations and financial arrangements which would either be barriers or enablers of ant EBP as they may promote or hinder services or best practices.
2.    Provide a short summary of the important information that relates to your clinical question, explain the rational for your decision making to your situation of uncertainty.
In the clinical question, there is an investigation of adult patients with hypertension and the effectiveness of CoQ10 as an alternative pharmacotherapy with clinical significance in lowering blood pressure in comparison to the use of conventional first line treatment with thiazides diuretics. In designing this clinical question, there was a research process which aimed to find a suitable article answering the question. The article by Rosenfeldt et al. (2007) was chosen since it explicitly addressed my issue of uncertainty with a clear and concise response.  Though the setting may be different, it is a suitable practice that can be extended to a suitable health care setting. The method used by the researchers directly answered my question providing a link that addressed my issue of uncertainty with evidence.

Burke BE, Neuenschwander R, Olson RD. Randomized, double-blind, placebo-controlled trial of coenzyme Q10 in isolated systolic hypertension. South Med J 2001; 94(11): 1112–1117. 23
Daley, M. J., Lat, I., Mieure, K. D., Jennings, H. R., Hall, J. B., Kress, J. P. 2013. A comparison of initial monotherapy with norepinephrine versus vasopressin for resuscitation in septic shock. Annals of Pharmacotherapy,47(3), pp. 301-310.
Digiesi V, Cantini F, Brodbeck B. Effect of coenzyme Q10 on essential arterial hypertension. CurrTher Res 1990; 47(5): 841–845.
Folkers K, Drzewoski J, Richardson PC, Ellis J, Shizukuiski S, Baker L. Bioenergetics in clinical medicine XVI: reduction of hypertension in patients by therapy with coenzyme Q10. Res CommChem Path Pharmacol 1981; 31(1): 129–140.
Grol, R., &Wensing, M. (2004). What drives change? Barriers to and incentives for achieving evidence-based practice.Medical Journal of Australia, 180(6 Suppl), S57.
Hulscher, M. E. J. L., Wensing, M., Weijden, T., &Grol, R. P. T. M. (1997).Interventions to implement prevention in primary care.The Cochrane Library.
Parahoo, K. 2014. Nursing research: Principles, process and issues. London: Palgrave Macmillan.
Rainbird K, Sanson-Fisher R, Buchan H.  2006. Identifying barriers to evidence uptake. Retrieved from www.nicsl.com.au
Rosenfeldt, F. L., Haas, S. J., Krum, H., Hadj, A., Ng, K., Leong, J., & Watts, G. F. (2007). Coenzyme Q10 in the treatment of hypertension: a meta-analysis of the clinical trials. Journal of human hypertension, 21(4), 297-306
Shaw, B., Cheater, F., Baker, R., Gillies, C., Hearnshaw, H., Flottorp, S., & Robertson, N. (1998). Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes.
Sibbald, B., & Roland, M. (1998). Understanding controlled trials. Why are randomised controlled trials important?.BMJ: British Medical Journal, 316(7126), 201.
Singh RB, Niaz MA, Rastogi SS, Shukla PK, Thakur AS.Effect of hydrosoluble coenzyme Q10 on blood pressures and insulin resistance in hypertensive patients with coronary artery disease.J Hum Hypertens 1999; 13(3): 203–208.

Assessment task 3: Critical review of evidence

Objective(s): This assessment task addresses subject learning objective(s): A, B, D, E, F and G

Subject objectives
Upon successful completion of this subject students should be able to:

A. Examine the role of evidence based practice in health care practice.

B. Convert a clinical problem into a focussed question to direct the search for research evidence.

C. Design an effective, reproducible and transparent search strategy to access relevant literature.

D. Critically appraise published research for rigor, applicability to a clinical setting and to understand whose voice is represented in the research.

E. Analyse, synthesise, and apply research evidence to inform decision-making in healthcare.

F. Examine the factors influencing the applicability and implementation of evidence-based practice into current healthcare.

G. Identify a gap in the literature, choose a feasible research topic, justify its significance and develop their research aims and objectives.

This assessment task contributes to the development of graduate attribute(s): 1.0, 3.0 and 4.0

This subject also contributes specifically to the following graduate attributes:

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