Hydrocortisones for COPD Patients - Essay Example

Hydrocortisones for COPD Patients Introduction My work is that of a private hospital paramedic and it is of great interest to me to explore the pre-hospital administration uses of hydrocortisones for COPD patients and how that can potentially improve patient outcomes. This paper details the results of an investigation of a PICO question tied to this area of interest, as the basis of a discussion on evidence search, practice guidelines and the manipulation of the evidence, focusing not on the actual PICO question but essentially on the process of arriving at evidence; refining the evidence search to more accurately sift through relevant pieces of evidence and screen out non-relevant pieces, taking into account the reliability and accuracy of the unearthed evidence via an exploration of the hierarchies of evidence; comparing and contrasting two practice guidelines tied to the practice area in the PICO question; and discussing the different ways and reasons for the manipulation of evidence. The point is the discussion of this outlined process, and not answering the PICO question itself nor actually going through the unearthed evidence nor discussing the topic of the PICO question. By way of definition, evidence-based practice or EBP refers to the rigorous, judicious and conscientious employ of the values of patients, expertise in clinical skill areas, and the best and most current evidence in making decisions tied to the health of patients. Best evidence implies the careful weighing of the available evidence from various sources, and therefore gives rise to the necessity of ranking different pieces of evidence for reliability and accuracy along suitable evidence hierarchies, and such evidence can come from randomized control trials or RCTs, qualitative research, case studies, and even the opinions of subject matter experts. Where research does not exist, inputs to guide decision-making can come from clinical experts, who take into account the values of the patients and couple them with scientific principles as well as the opinions of experts to make the best possible healthcare decisions for patients. Systematized deliberate research is an important aspect of evidence based practice (Titler 2008; Sackett et al. 1996). PICO Question, the Evidence Search PICO Question The undertaking of an evidence search took off around the following PICO question: ‘In UK patients with acute exacerbation of COPD, would the pre-hospital administration of hydrocortisone drugs compared to no drugs or other drugs result in improved patient outcomes?’The key means for unearthing evidence for this PICO question is a search for relevant literature in credible databases, as well as available credible literature available on the Internet Google Scholar portal and related online medical literature databases such as the one provided by the NCBI PubMed (Google 2015; National Center for Biotechnology Information 2015). Evidence Search A broad and ordinary Google search involving the two terms ‘hydrocortisone COPD’ is arguably the most generic search that can be undertaken that is relevant for the PICO question stated above. Here the results are impressive and large, with total links reported at around 289,000, and with the top results intriguingly including credible links to studies from the NCBI, The American Family Physician, and The American Journal of Health-System Pharmacy. Going through the different sources without yet weighing in on the accuracy and reliability of the source publications that carried them, and of the nature of the studies and articles themselves, one sees that all of them make reference to exacerbations of COPD and the routine prescription of hydrocortisones as emergency or on-going treatment. These initial results are encouraging, and show us that there is a rich mine of literature that can be explored with increasing refinement and precision in aid of answering the PICO question. From here the concerns relate to grading the different sources using suitable hierarchies of evidence, and making appropriate refinements to the search in order to fine-tune the gathered evidence and come up with the best kinds in aid of answering the PICO question and in aid of the overall goal of using the best evidence in an EBP setting so to speak (Schweiger and Zdanowicz 2010; Hunter and King 2001; Currie and Wedzicha 2006). Naturally we want to refine the search and here the literature tells us that there are common Boolean operators that can be employed on databases in order to do this refinement of search. The common Boolean operators AND, OR and NOT, in conjunction with the experimentation with various search phrases and words, can effect the refinement in the search for evidence from the initial large net that had been cast so to speak using the phrase COPD hydrocortisone as the initial search phrase. It is worth noting moreover that in Google, entering the two words without any qualifiers is equivalent to an AND search; that is, in the search undertaken above it is implied that the search was for COPD AND hydrocortisone, giving us a wealth of resources the top links of which turned out to be links to good studies from publications of good reputation and peer-reviewed journals, as detailed above (Nickless 2012; University of Washington Libraries 2015). Moving forward with another AND search, we look for the phrase “COPD exacerbation” and hydrocortisone, with the understanding that we are looking for the exact phrase “COPD exacerbation” together with any occurrence of the word hydrocortisone. The exact search phrase to execute this is “COPD exacerbation” AND hydrocortisone or just “COPD exacerbation” hydrocortisone. This will look for references with the exact phrase “COPD exacerbation” together with hydrocortisone occurring together in relevant sources. Here we see that there is an immediate and drastic reduction in the number of relevant sources from the previous search results, to just about 401 sources in Google Scholar, whereas the initial generic search looked at the entire Internet and used the more generic search term COPD AND hydrocortisone. Similar searches using the Boolean operators OR and NOT yield similar refinements in results (Google 2015). Having used Google as a test bed, we move on to the Quest resources at the EBSCOHOST site for the University of Cumbria. Here a simple Boolean search with the phrase ‘exacerbation COPD’ AND hydrocortisone yields four results, which neatly drills down to the most relevant sources for this topic. Relaxing the search to COPD and hydrocortisone yields a greater number of resources, at 32. Again this greater number tells us of a positive link between the two. A more complex search making use of the Boolean operators AND and OR yields a greater number of resources, at 71,848 resources, for the search term ‘COPD AND hydrocortisone OR corticosteroids’. A search using the Boolean operator NOT yields 43,959 resources for the search term ‘COPD NOT hydrocortisone’. These results tell us that there is a wealth of resources on COPD in general, and that there are large numbers of resources that can be mined for evidence that have references to the use of hydrocortisone as an intervention (EBSCO Industries 2015). Hierarchy of Evidence The literature tells us that the need for best evidence to guide evidence-based practice necessarily requires the ability to discern good evidence from bad evidence, and therefore one naturally begins talking about grading evidence based on a hierarchy. Hierarchies of evidence abound, but generally all look at the design of the study and the quality of the study as primary criteria for judging the quality of the evidence. On a hierarchy, the best evidence has the highest ratings, or 1 usually, while poor quality evidence are rated lower, around 4 or lower. The literature on healthcare in general is said to be classifiable most broadly as either being observational in its essence or one that has an experimental design that is deliberately randomized, and between the two, the latter is said to yield generally better quality evidence on higher rungs of the hierarchy of evidence because of the way the very design weeds out bias-based errors or deviations from the truth. This translates practically to randomized control trials or RCTs and the next-closest thing, meta-analyses of RCTs that make use of data from RCTs and pool those data for statistical analytical purposes. The latter expand the sample sizes for consideration and that in itself has value in making the results of subsequent analyses more accurate and more reliable. These two designs are able to avoid inherent biases that are difficult to weed out in study designs that are more observational in nature, and which in turn therefore yield evidence that sit lower in different hierarchies of evidence. Moreover, in meta-analyses of RCTs homogeneous meta-analysis studies, or studies that show similar results, have higher ratings on the hierarchy than those that are heterogeneous. On the other extreme are the lowest rated evidence in the hierarchy, and they come from case series and case reports. They are more often than not retrospective studies whose results have validity only for the studied sample, and often lack groups with which to compare results. The case-control sits on top of this lowest rung, and has its own sets of benefits, including ease of use when the risk factors are known that contribute to the occurrence of an event of interest. Still higher than that is the cohort study which is often designed prospectively, and compares two groups, one a control group, and the key group having the risk factor for the characteristics of interest, and their progress are tracked through time. There are distinctions too among the different study design types based on the overall quality of the study and the methodologies employed that impact their grades along hierarchies of evidence (Petrisor and Bhandari 2007). . Meanwhile, the literature further expands the hierarchy on both ends by placing expert opinion and non-experimental designs on even lower rungs of the hierarchy, while placing systematic reviews and so-called multicentre-studies that take into account various populations and a broader array of patient settings as well as circumstantial data. These latter studies are said to even supersede RCTs on top of the hierarchy, for the way they are able to generate evidence that is of the best reliability and validity (Evans 2002; Fitzpatrick 2007). Practice Guidelines This section evaluates two practice guidelines for COPD making use of a suitable guideline analysis tool, and in this case the chosen analysis tool is the one prescribed in the January 2009 issue of JAMA 309 (2), which can be construed as a prescriptive guide for evaluating clinical practice guidelines for probity, trustworthiness and safe use. This guidelines takes into account such aspects of the crafting and on-going revision of clinical guidelines as transparency, interest conflicts, the composition of the group that drafted and that maintains the guidelines, the quality of the evidence employed and the strength of the recommendation, the facility for external reviews, the way recommendations are articulated, and the way the guidelines are updated (Ransohoff, Pignone and Sox 2013, pp. 139-140). One such clinical practice guideline for COPD is the one created by the American College of Physicians and espoused by the American Thoracic Society. The billing for the update to this clinical practice guideline is impressive and reads like a who’s who of the gatekeepers of mainstream medicine with regard to COPD and related diseases: The American College of Physicians, the American College of Chest Physicians, the European Respiratory Society, and the American Thoracic Society. In terms of transparency, the offer of transparency is reflected in the update to the guideline having the official seal of the parties involved, reflecting and indicating transparency in the way the guidelines were crafted, being above board and official, and having behind it the weight of the authority of the parties involved. This vetting process for authority has in it the implications that the entire process had been vetted by members of the groups, ensuring integrity and transparency in the drafting process. The composition too reflects behind it the marshalling of evidence and the participation of both clinicians and patients in the crafting of the updates to the guidelines. Moreover, evidence is presented and the scope of the evidence that was made the basis of the updates were provided. The recommendations moreover for changes to the clinical practice guidelines were explained in detail, and had the backing of appropriate references to high quality studies and evidence, and properly documented in the references section. The quality of the evidence is high and the strength of the recommendations is also high, given the extensive documentation and the extensive references to high quality studies that are recent, and peer-reviewed. The recommendations are detailed, exact, and for each of the recommendations there is a rating for the strength of the recommendation as well as for the quality of the evidence, so that for the sixth recommendation for instance, there is a strong rating for the recommendation and a moderate rating for the quality of the evidence used. The presence of the formal authority and the formal approval of different bodies all focused on COPD and specialist organizations in the field make for a body of societies that mutually check and review each others’ work and recommendations tied to the clinical practice guidelines for COPD, suggesting unanimity and universal adoption of the guidelines (Qaseem et al. 2011, pp. 179-191). A comparable and alternative set of clinical practice guidelines for COPD is provided by Malaysian health professionals and endorsed by the Malaysian Ministry of Health, the Malaysian Academy of Medicine, and the Malaysian Thoracic Society. The composition of the group that drafted the guidelines is given, and is by invitation from the authorities, involving some medical centers, a physician specialist, and an educational institution, among others. The composition is entirely Malaysian in character, and so are the external reviewers of the guidelines. This is a chiefly Malaysian clinical practice guidelines set. On the other hand, from a transparency perspective, there seems little by way of public participation in the way the composition of the drafting group was determined, even as the vetting in terms of qualifications is more or less reliable, given that the guidelines is the official document of the Malaysian government. There are no details however with regard to any conflicts of interest among the stakeholders in the document, again reflecting an aspect of the relative lack of transparency in the crafting of the drafting group and in the way the document was created overall. There are no ratings for recommendation strength and the referencing of the recommendations and the discussions is not always rigorous, even as the references list is long. In contrast to the American guidelines though, this latter set of guidelines did not rate the quality of the evidence tied to making the recommendations. Recommendations too are not always measurable and exact, and need to be fleshed out. The details of some of the recommendations, such as what constitutes a balanced diet for instance, are not well-articulated and referenced (Ministry of Health Malaysia 2009, pp. 20-46). The evaluation tool that was provided in the JAMA article for the assessment of the trustworthiness of clinical practice guidelines is straightforward in prescribing the things one should look at in weighing the overall value and usability of such clinical guidelines. Looking at the above discussion, one can see that as far as the criteria in JAMA are concerned, the former set of clinical guidelines from the American Society of Physicians seem to be more credible and trustworthy. It is more rigorous in its presentation of the evidence and of the rating of the quality of the evidence, and it provides ratings for the strengths of each of the six recommendations as well. The selection process for the membership into the group that drafts the guidelines is transparent, and benefits from the joint effort of all the organizations involved and the inherent probity and rigor in which the selection process is conducted. The review process is rigorous and external reviews are implied in the joint declaration of adoption from the major societies involved. Moreover, the referencing is rigorous, and is well-explained in terms of the inclusive dates of the evidence that were considered and used to come up with the guideline recommendations. The easy choice for adoption in actual practice is the one from the American College of Physicians (Qaseem et al. 2011, pp. 179-191; Ransohoff, Pignone and Sox 2013, pp. 139-140). Manipulating the Evidence This section is a critical discussion of the ways in which evidence can be manipulated and the reasons for such manipulation in clinical settings. The focus of the discussion is the impact of reporting in media. The nature of the issue is straightforward and easily understood in context. For instance, discussions on how evidence in support of the approval of certain new drugs and devices point to allegations of manipulation and the behind the scenes work of lobbies that work for pharmaceutical companies, in order to fudge the data and massage the interpretation of evidence in favor of approval. In related contexts, big pharmaceutical firms and/or their lobbies can then conscript media to present the drug in favorable terms, or else to deflect criticism relating to the unwanted side effects of their drugs and the perceived misrepresentation of the true benefits versus the risks of the medications. Still in other contexts big pharmaceutical firms and their lobbies downplay serious incidents that involve deaths with the use of certain drugs, and downplay new discoveries about clinical evidence pointing to serious harm from the continued use of certain drugs, and make use of media in order to help massage the evidence and present evidence that is favorable to the drug’s continued use. If we look at the motivations and reasons for manipulation of course we see financial motivations and the way media can sometimes be beholden to big business who after all pays the advertising revenues that are so critical for the continued viability of the media platforms. Media such as TV and print media rely on advertising revenues to exist and make money, and of course where the financial motivations are great enough, such as big pharmaceutical firms taking their advertising budgets elsewhere when a media channel is uncooperative, media may have motivations to side with the big pharmaceutical firms (Whiteout Press 2014; Alliance for Natural Health 2014). With media in other words the manipulation of the evidence is done in the context of the misrepresentation of the evidence to suit the interests of some stakeholders, namely the advertisers cum pharmaceutical companies who pay the bills of the media companies, to the detriment of the larger interests of the public and the community, whose health outcomes are put on the line arguably in the name of profits. Profits are the motivation, and the manipulation is in terms of presenting evidence that suits the needs of certain parties. There are many ways by which this misrepresentation of the evidence by the media has been put into effect. A famous and recent example pitted allegations that Robin Williams was killed, or compelled to suicide, as a side effects of the medications that he took to combat Parkinson’s disease. The allegations linking the suicide of the world-famous actor were made by another famous comedian using the social media platform Twitter, and the combined audiences of the two actors made for a large mass of people who were relayed the message of the deadly link between drugs to treat Parkinson’s disease and suicide. Simply put, Rob Schneider flagged the world of the stated side effects of Parkinson’s medications, something that may or may not be known by people and the families of people who take the drugs. This is the unearthing of clinical evidence that may have been downplayed by big pharma in their zeal to market the drugs and to make money off them. On the other hand, the role of media and their brand of evidence manipulation is said to have been evident in the way media was used by big pharma to air its side of the issue and to basically downplay Rob Schneider’s allegations. ABC News, to refute Rob Schneider, specifically mentioned the actor in a headline that pitted him against “experts” who basically “blasted” the actor for his critical Twitter posts. To manipulate the evidence further, big pharma reportedly employed Good Morning America, a bastion of mainstream media, and used an expert to cite a very dated study going back to 2001 saying that people with Parkinson’s in fact are ten times less likely to kill themselves. The manipulation and misrepresentation here is that the media outlet chose an outdated study to refute the claims of Schneider, even as it downplayed more recent evidence that some Parkinson’s drugs do have the side effect of inducing a greater propensity towards suicides in patients. In the end the media organization did sneak in this caveat, but in a swift side note, and here the manipulation of evidence via the way the evidence is presented, highlighting outdated evidence and presenting more damning, recent evidence as a side note, is in display (WhiteOut Press 2014; Neporent 2014). Another instance of media manipulating the evidence is via paying media personalities who have large followings to market drugs and to trump up the clinical evidence about the effectiveness of drugs for purposes that are not approved by the authorizes. One case of such media manipulation of the evidence is that of Dr. Drew Pinsky, who, without telling his audiences he was being paid by GlaxoSmithKline to push the drug Wellbutrin to his audiences, and using targeted marketing messages that are short on clinical evidence about the purported benefits of the drug, was able to make claims about the drug and was able to effectively market the drug, circumventing prohibitions against marketing drugs for unapproved purposes. Here the manipulation is in terms of not disclosing any conflicts of interest, and in presenting claims that are not backed up by proper clinical evidence and not approved by the authorities (Vox 2012). The implications of media manipulation of clinical evidence are profound. One, people needs to be more discerning when it comes to the information on drugs and other relevant aspects of their health that media relays to them. Two, there are serious public interest and ethical issues that need to be investigated and addressed when media outlets that are supposed to work for the public interests become beholden to private interests motivated more by profit than by the public good (Vox 2012; WhiteOut Press 2014). Conclusion/ Opportunities One can see that from the preceding discussion, the PICO question and the process of answering the PICO question is a rich vein of inquiry and research that opens up opportunities to learn and to deepen skills in evidence search, evidence evaluation, evidence grading, and the proper mustering of the best evidence to fuel evidence-based practices. All these skills are put to use in the end in coming up with the best possible interventions to improve patient outcomes in various settings and for various conditions. In this case, the process outlined here can potentially improve patients with COPD and exacerbations of COPD. The discussions on evidence search is an opportunity to deepen one’s skills relating to adeptly navigating through databases in order to refine searches for the most relevant evidence. The discussion on the hierarchy of evidence on the other hand points to opportunities to be able to make use of the most reliable and trustworthy evidence from studies with good design and overall good quality, and certain kinds of studies that take away bias and that provide good evidence are preferable, and of higher quality, than other kinds of evidence. This is not to say that lower quality evidence such as expert opinions are not important, but that one can make more nuanced decisions based on knowledge of the quality of the evidence that is used to make decisions. In the context of clinical practice guidelines for instance, where the quality of the evidence is high, then one can be more confident in adopting recommendations tied to that evidence. On the other hand, where the quality of the evidence is not so high, there is room to explore other recommendations and options where the supporting evidence is of better quality. Finally, the discussion on the manipulation of evidence is also an opportunity to be more critical not just in rating evidence but also in seeing how the evidence is interpreted and presented (Sboros 2015; Evans 2002; Schweiger and Zdanowicz 2010). 1 References Alliance for Natural Health (2014). How Big Pharma and the Media Sell Junk Science. ANH USA. [online]. Available at: http://www.anh-usa.org/selling-junk-science/ [accessed 4/27/2015] Avery, G. (2010). Scientific Misconduct: The Manipulation of Evidence for Political Advocacy in Health Care and Climate Policy. Cato Institute. [online]. Available at: http://www.cato.org/publications/briefing-paper/scientific-misconduct-manipulation-evidence-political-advocacy-health-care-climate-policy [accessed 4/27/2015] Currie, G. and Wedzicha, J. (2006). Acute exacerbations. BMJ 333. [online]. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1489228/ [accessed 4/27/2015] Evans, D. (2002). Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions. Journal of Clinical Nursing 12 (1). [online]. Available at: http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2702.2003.00662.x/full [accessed 4/27/2015] EBSO Industries (2015). Result List: COPD NOT hydrocortisone. Quest/EBSCOHost. [online]. Available at: http://eds.b.ebscohost.com/ [accessed 4/29/2015] Fitzpatrick, J. (2007). Finding the research for evidence-based practice - PART ONE - The development of EBP Nursing Times. [online]. Available at: http://www.nursingtimes.net/home/specialisms/infection-control/finding-the-research-for-evidence-based-practice-part-one-the-development-of-ebp/292457.article [accessed 4/27/2015] Google (2015). Google Scholar. scholar.google.com. [online]. Available at: scholar.google.com [accessed 4/27/2015] Healthcare Renewal (2013). How Manipulated Clinical Evidence Could Distort Guidelines - the Case of Statins for Primary Prevention. HCR Blog. [online]. Available at: http://hcrenewal.blogspot.com/2013/12/how-manipulated-clinical-evidence-could.html [accessed 4/27/2015] Hunter, M. and King, D. (2001). COPD: Management of Acute Exacerbations and Chronic Stable Disease. American Family Physician. [online]. Available at: http://www.aafp.org/afp/2001/0815/p603.html [accessed 4/27/2015] Ministry of Health Malaysia (2009). Management of Chronic Obstructive Pulmonary Disease. Clinical Practice Guidelines. [online]. Available at: http://www.moh.gov.my/attachments/4749.pdf [accessed 4/27/2015] National Center for Biotechnology Information (2015). PubMed Home. [online]. Available at: http://www.ncbi.nlm.nih.gov/pubmed [accessed 4/27/2015] Neporent, L. (2014). Doctors Blast Rob Schneider’s Parkinson’s Drug Twitter Rant. ABC News via Good Morning America. [online]. Available at: http://abcnews.go.com/Health/experts-blast-rob-schneiders-parkinsons-drug-twitter-rant/story?id=25041317 [accessed 4/29/2015] Nickless, A. (2012). Using Boolean Search Operators with Google. Amy’s Scrap Bag Blog. [online]. Available at: https://amysscrapbag.wordpress.com/2012/11/05/boolean-operators-and-google/ [accessed 4/27/2015] Petrisor, B. and Bhandari, M. (2007). The hierarchy of evidence: Levels and grades of recommendation. Indian Journal of Orthopaedics 41 (1). [online]. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2981887/ [accessed 4/27/2015] Qaseem, A. et al.. (2011). Diagnosis and Management of Stable Chronic Obstructive Pulmonary Disease: A Clinical Practice Guideline Update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. ACP Clinical Practice Guidelines. [online]. Available at: https://www.thoracic.org/statements/resources/copd/179full.pdf [accessed 4/27/2015] Ransohoff, D. , Pignone, M. and Sox, H. (2013). How to Decide Whether a Clinical Practice Guideline Is Trustworthy. JAMA 309 (2). Sackett, D. et al. (1996). Evidence based medicine: what it is and what it isn’t. BMJ 1996: 312:71. [online]. Available at: http://www.ncope.org/summit/pdf/Footnote1.pdf, [accessed 4/27/2015] Sboros, M. (2015). Doctors in state of confusion over statins. Business Day Live. [online]. Available at: http://www.bdlive.co.za/life/health/2015/03/19/doctors-in-a-state-of-confusion-over-statins [accessed 4/27/2015] Schweiger, T. and Zdanowicz, M. (2010). Systemic Corticosteroids in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease. American Journal of Health-System Pharmacy 67 (13). [online]. Available at: http://www.medscape.com/viewarticle/723940_9 [accessed 4/27/2015] Titler, M. (2008). Chapter 7: The Evidence for Evidence-Based Practice Implementation. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. [online]. Available at: http://www.ncbi.nlm.nih.gov/books/NBK2659/ [accessed 4/27/2015]. Turchiano, R. (2015). Statin drug data criminally manipulated to show exaggerated benefit and reduced risk? Engineering Evil Blog. [online]. Available at: http://engineeringevil.com/2015/02/20/statin-drug-data-criminaly-manipulated-to-show-exaggerated-benefit-and-reduced-risk/ [accessed 4/27/2015]. University of Washington Libraries (2015). Expert Google Searching Part 1: Using Boolean operators and phrase searching. University of Washington. [online]. Available at: http://guides.lib.washington.edu/content.php?pid=55083&sid=429391 [accessed 4/27/2015]. Vox, F. (2012). How Dr. Drew Sold His Cred to Big Pharma. The Atlantic. [online]. Available at: http://www.theatlantic.com/health/archive/2012/07/how-dr-drew-sold-his-cred-to-big-pharma/259473/ [accessed 4/29/2015]. Whiteout Press (2014). Rob Schneider Says Big Pharma Killed Robin Williams. WhiteOutPress. [online]. Available at: http://www.whiteoutpress.com/articles/2014/q3/rob-schneider-says-big-pharma-killed-robin-williams/ [accessed 4/29/2015]. Read More