Guidelines Assessment - Research Paper Example

?Clinical practice guidelines are formed and implemented in clinical situations and specify criteria with respect to diagnoses and treatment in healthcare, as well as regarding clinical management (Davis & Taylor-Vaisey., 1997). Historically, these have been based merely on tradition, but modern clinical practice guidelines are formed based upon several different factors within evidence-based medicine. Modern clinical practice guidelines are often evaluated using the GLIA system (GuideLine Implementability Appraisal) and the AGREE instrument (Appraisal of Guidelines for Research and Evaluation). The availability of these systems is evidence of how carefully regulated these guidelines are and how they can be particularly useful in clinical situations (Field et al., 1990). The principal steps in developing a clinical practice guideline are as follows. In the first instance, the correct information needs to be identified and this should be the most current and most relevant data available concerning the diagnosis, treatment and management of the illness in question. Information should also be gathered about the cost and risk of the above, where applicable (Davis & Taylor-Vaisey, 1997). Having put all this data in place, it is then necessary to condense the information to provide it in a format readily available to clinicians (Michie & Johnston, 2004) and condense this into a format useable in practical situations. Then, clinicians must implement the guidelines (Davis & Taylor-Vaisey, 1997), although this has been found to be difficult in many cases (Cabana et al., 1999; Michie & Lester, 2005). Clinical practice guidelines can involve computer algorithms, and their formulation can be heavily reliant on information technology (Field et al., 1990). The purpose of the AGREE instrument is to stress that the usefulness of these clinical practice guidelines is proportional to the quality of the guidelines themselves. This means that the AGREE instrument is primarily concerned with providing a framework with which to assess these guidelines, and states that it will: Assess the quality of guidelines; Provide a methodological strategy for the development of guidelines; and Inform what information and how information ought to be reported in guidelines. (AGREE Next Steps Consortium, 2009) This is taken from the newest version of the AGREE instrument, which is currently version two. As is evidenced by these statements, the AGREE instrument aims to ensure that all guidelines will beneficial to both clinicians and patients. Clinical practice guidelines should provide the very best and most recent research to clinicians so that treatment, diagnosis and management of the illness in question is of the best standard possible. The AGREE instrument also ensures that clinical practice guidelines are formulated in a methodical way, and so all clinical practice guidelines formulated using this tool will be of the same standard and format, and thus the AGREE instrument is now a reliable quality evaluation tool. The AGREE instrument separates the information it provides into domains. The first domain is known as ‘scope and purpose’, which basically ensures that the basic properties of the guideline are adequately described, such as the target audience, the health questions and the objectives. The second domain is ‘stakeholder involvement’ which suggests that the discussion of the guideline involves professionals from every available and appropriate area, and that the target audience have also been consulted also. The third domain is defined as ‘rigour of development’ and essentially aims to ensure that all the evidence has been selected in an appropriate manner and that this is described in the guideline, that the strengths and weaknesses of the evidence are recognized, and that the guideline explicitly references this evidence. It also aims to provide information on how to update the procedure when necessary. The fourth domain is ‘clarity of presentation’ and aims to ensure that all guidelines are accessible and understandable and presents different options for treatment and management in an easily interpreted fashion. The fifth domain is a measure of ‘applicability’ and deals with any obstacles or benefactors to the application of this guideline. It also stipulates how the guideline should be implemented and should present monitoring criteria. The final domain is known as ‘editorial independence’ and ensures that the body providing the funding for the development of the criteria has no effect on the impartiality of the professionals consulted. AGREE is, then, essentially a tool for ensuring that these guidelines are formulated in the proper manner. This means that they should only be used for the development of clinical practice guidelines, although referencing the AGREE instrument to ensure that the guideline in practice is correctly formulated is also recommended. The GLIA system, on the other hand, is more concerned with the implementability of the guideline and is a measure of factors completely intrinsic to the guideline and as such concerns itself with how and how well the guideline should be implemented in a clinical setting. The GLIA guidelines state that the following should be considered: executability; decidability; validity; flexability; the effect on process and care; measurability; novelty and innovation value; and the compatibility. Additionally it is important to note that the GLIA system is used per recommendation, not per guideline, and as such the implementability stated should be considered as a rating of a specific item within the guideline. Again, this can be considered a major difference between the GLIA and AGREE systems and specifies how each one should be used in a different context. Guidelines The following guidelines were formulated with reference to various statements found in the work of Macintyre et al., (2007) with regards to paracetamol in the context of coxibs, NSAIDs and analgesics, with the relevant statements from each guideline being shown below the relevant guideline. The statements are followed by a number, which refers to the levels of evidence, which are shown in the table below and are found within the same book as the statements. These will then be assessed using GLIA, although the GLOBAL component is not used as these recommendations are individual and have not been formulated as part of a clinical practice guideline. Levels of evidence Level I Evidence obtained from a systematic review of all relevant randomised controlled trials. Level II Evidence obtained from at least one properly designed randomised controlled trial. Level III-1 Evidence obtained from well-designed pseudo-randomised controlled trials (alternate location or some other method). Level III-2 Evidence obtained from comparative studies with concurrent controls and allocation not randomised (cohort studies), case-controlled studies, or interrupted time series with a control group. Level III-3 Evidence obtained from comparative studies with historical control, two or more single-arm studies, or interrupted time series without a parallel control group. Level IV Evidence obtained from case studies, either post-test or pre-test and post-test. Clinical practice points Recommended best practice based on clinical experience and expert opinion Paracetamol should be used as part of treatment for the relief of acute pain following tonsillectomy. It should be administered as part of both pre- and post-operative pain relief. Evidence: Paracetamol is an effective analgesic for acute pain; the incidence of adverse effects is comparable to placebo. (Level 1, Cochrane Review) Coxibs are effective in the treatment of postoperative pain. (Level 1 Cochrane Review) In general, aspirin increases bleeding after tonsillectomy. (Level 1) Preoperative coxibs reduce postoperative pain, and increase patient satisfaction. (Level 1) GLIA Assessment: Executability 10) Is the recommended action (what to do) stated specifically and unambiguously? That is, would the intended audience execute the action in a consistent way? Y 11) Is sufficient detail provided or referenced (about how to do it) to allow the intended audience to perform the recommended action. N Comments: Although the guideline states that it should be used as part of both pre- and post-operative pain treatment, there should be information about the precise timings of these treatments. Decidability 12) Would the guideline's intended audience consistently determine whether each condition in the recommendation has been satisfied? That is, is each and every condition described clearly enough so that reasonable practitioners would agree when the recommendation should be applied? Y 13) Are all reasonable combinations of conditions addressed? Y 14) If this recommendation contains more than one condition, is the logical relationship (ANDs and ORs) between conditions clear? N/A Comments: None Validity 15) Is the justification for the recommendation stated explicitly? Y 16) Is the quality of evidence that supports each recommendation stated explicitly? Y Comments: None Flexibility 17) Is the strength of each recommendation stated explicitly? Note: Strength of recommendation reflects anticipated level of adherence and is different from quality of evidence (question 16). Potential statements to satisfy this criterion might include “Strong recommendation”, “Standard”, Clinical option”, etc. Y 18) Does the recommendation specify patient characteristics (such as coincident drug therapy and common co-morbid conditions) that require or permit individualization? N 19) Does the recommendation specify practice characteristics (such as location and availability of support services) that require or permit modification? N/A Comments: Information should be specified as to how the treatment should be administered with respect to other medications as well as common co-morbid conditions. Effect of Process on Care 20) Can the recommendation be carried out without substantial disruption in current workflow? Y 21) Can the recommendation be pilot tested without substantial resource commitment? For example, buying and installing expensive equipment to comply with a recommendation is not easily reversible. Y Comments: None Measureability 22) Can adherence to this recommendation be measured? Measurement of adherence requires attention to both the actions performed and the circumstances under which the actions are performed. Y 23) Can outcomes of this recommendation be measured? Outcomes include such things as changes in health status, mortality, costs, and satisfaction. Y Comments: None Novety/Innovation 24) Can the recommendation be performed by the guideline’s intended users without acquisition of new knowledge or skills? Y 25) Is the recommendation consistent with existing attitudes and beliefs of the guideline’s intended audience? Y 26) Is the recommendation consistent with patient expectations? In general, patients expect their concerns to be taken seriously, benefits of interventions to exceed risks, and adverse outcomes to fall within an acceptable range Y Comments: Note that the evidence also suggests that: Coxibs do not impair platelet function; this leads to reduced perioperative blood loss in comparison with non-selective NSAIDS. (Level II) Computability 27) Are all patient data needed for this recommendation available electronically in the system in which it is to be implemented? Y 28) Is each condition of the recommendation defined at a level of specificity suitable for electronic implementation? Y 29) Is each recommended action defined at a level of specificity suitable for electronic implementation? Y 30) Is it clear by what means a recommended action can be executed in an electronic setting, e.g., creating a prescription, medical order, or referral, creating an electronic mail notification, or displaying a dialog box? N Comments: The recommendation does not give specific details on how the recommended action can be executed in an electronic setting. NSAIDs should be used as part of treatment in a clinical setting for the treatment of post-operative acute pain, although this should be used with caution in patients with any existing renal impairments. NSAIDs should not be used in a perioperative manner. Evidence: Perioperative non-selective NSAIDS increase the risk of severe bleeding after a variety of other operations compared with placebo. (Level II) The risk of adverse renal effects of non-selective NSAIDS and coxibs is increased in the presence of factors such as pre-existing renal impairment, hypovolaemia, hypotension, use of other nephrotoxic agents and ACE inhibitors. (Clinical experience and expert opinion) Non-selective NSAIDS and coxibs are effective analgesics of similar efficacy for acute pain. (Level 1) Non-selective NSAIDS given in addition to paracetamol improve analgesia compared with paracetamol alone. (Level 1) With careful patient selection and monitoring, the incidence of nsNSAID-induced perioperative impairment is low. (Level 1, Cochrane Review) Non-selective NSAIDS do not increase the risk of reoperation for bleeding after tonsillectomy in paediatric patients. (Level 1, Cochrane Review) Non-selective NSAIDS are effective in the treatment of postoperative and low back pain, renal colic and primary dysmenorrhoea. (Level 1, Cochrane Review) GLIA Assessment: Executability 10) Is the recommended action (what to do) stated specifically and unambiguously? That is, would the intended audience execute the action in a consistent way? Y 11) Is sufficient detail provided or referenced (about how to do it) to allow the intended audience to perform the recommended action. Y Comments: None Decidability 12) Would the guideline's intended audience consistently determine whether each condition in the recommendation has been satisfied? That is, is each and every condition described clearly enough so that reasonable practitioners would agree when the recommendation should be applied? Y 13) Are all reasonable combinations of conditions addressed? Y 14) If this recommendation contains more than one condition, is the logical relationship (ANDs and ORs) between conditions clear? N/A Comments: None Validity 15) Is the justification for the recommendation stated explicitly? Y 16) Is the quality of evidence that supports each recommendation stated explicitly? Y Comments: None Flexibility 17) Is the strength of each recommendation stated explicitly? Note: Strength of recommendation reflects anticipated level of adherence and is different from quality of evidence (question 16). Potential statements to satisfy this criterion might include “Strong recommendation”, “Standard”, Clinical option”, etc. Y 18) Does the recommendation specify patient characteristics (such as coincident drug therapy and common co-morbid conditions) that require or permit individualization? Y 19) Does the recommendation specify practice characteristics (such as location and availability of support services) that require or permit modification? N/A Comments: Effect of Process on Care 20) Can the recommendation be carried out without substantial disruption in current workflow? Y 21) Can the recommendation be pilot tested without substantial resource commitment? For example, buying and installing expensive equipment to comply with a recommendation is not easily reversible. Y Comments: None Measureability 22) Can adherence to this recommendation be measured? Measurement of adherence requires attention to both the actions performed and the circumstances under which the actions are performed. Y 23) Can outcomes of this recommendation be measured? Outcomes include such things as changes in health status, mortality, costs, and satisfaction. Y Comments: None Novety/Innovation 24) Can the recommendation be performed by the guideline’s intended users without acquisition of new knowledge or skills? Y 25) Is the recommendation consistent with existing attitudes and beliefs of the guideline’s intended audience? Y 26) Is the recommendation consistent with patient expectations? In general, patients expect their concerns to be taken seriously, benefits of interventions to exceed risks, and adverse outcomes to fall within an acceptable range Y Comments: None Computability 27) Are all patient data needed for this recommendation available electronically in the system in which it is to be implemented? Y 28) Is each condition of the recommendation defined at a level of specificity suitable for electronic implementation? Y 29) Is each recommended action defined at a level of specificity suitable for electronic implementation? Y 30) Is it clear by what means a recommended action can be executed in an electronic setting, e.g., creating a prescription, medical order, or referral, creating an electronic mail notification, or displaying a dialog box? N Comments: The recommendation does not give specific details on how the recommended action can be executed in an electronic setting. Non-selective NSAIDs should be used in place of paracetamol when used as part of post-operative pain relief in conjunction with PCA opioids, to reduce both opioid consumption and opioid-related side-effects. Clinicians should be reminded of this preference by electronic mail when prescribing post-operative treatment. Evidence: Paracetamol when given in addition to PCA opioids reduces opioid consumption but does not result in a decrease of opioid-related side effects. (Level 1) Non-selective NSAIDS given in addition to PCA opioids reduces opioid consumption and the incidence of nausea, vomiting and sedation. (Level 1) Coxibs when given in addition to PCA opioids reduces opioid consumption but does not result in a decrease of opioid-related side effects. (Level 1) GLIA Assessment: Executability 10) Is the recommended action (what to do) stated specifically and unambiguously? That is, would the intended audience execute the action in a consistent way? Y 11) Is sufficient detail provided or referenced (about how to do it) to allow the intended audience to perform the recommended action. Y Comments: None Decidability 12) Would the guideline's intended audience consistently determine whether each condition in the recommendation has been satisfied? That is, is each and every condition described clearly enough so that reasonable practitioners would agree when the recommendation should be applied? Y 13) Are all reasonable combinations of conditions addressed? Y 14) If this recommendation contains more than one condition, is the logical relationship (ANDs and ORs) between conditions clear? N/A Comments: None Validity 15) Is the justification for the recommendation stated explicitly? Y 16) Is the quality of evidence that supports each recommendation stated explicitly? Y Comments: None Flexibility 17) Is the strength of each recommendation stated explicitly? Note: Strength of recommendation reflects anticipated level of adherence and is different from quality of evidence (question 16). Potential statements to satisfy this criterion might include “Strong recommendation”, “Standard”, Clinical option”, etc. Y 18) Does the recommendation specify patient characteristics (such as coincident drug therapy and common co-morbid conditions) that require or permit individualization? Y 19) Does the recommendation specify practice characteristics (such as location and availability of support services) that require or permit modification? N/A Comments: Effect of Process on Care 20) Can the recommendation be carried out without substantial disruption in current workflow? Y 21) Can the recommendation be pilot tested without substantial resource commitment? For example, buying and installing expensive equipment to comply with a recommendation is not easily reversible. Y Comments: None Measureability 22) Can adherence to this recommendation be measured? Measurement of adherence requires attention to both the actions performed and the circumstances under which the actions are performed. Y 23) Can outcomes of this recommendation be measured? Outcomes include such things as changes in health status, mortality, costs, and satisfaction. Y Comments: None Novety/Innovation 24) Can the recommendation be performed by the guideline’s intended users without acquisition of new knowledge or skills? Y 25) Is the recommendation consistent with existing attitudes and beliefs of the guideline’s intended audience? Y 26) Is the recommendation consistent with patient expectations? In general, patients expect their concerns to be taken seriously, benefits of interventions to exceed risks, and adverse outcomes to fall within an acceptable range Y Comments: None Computability 27) Are all patient data needed for this recommendation available electronically in the system in which it is to be implemented? Y 28) Is each condition of the recommendation defined at a level of specificity suitable for electronic implementation? Y 29) Is each recommended action defined at a level of specificity suitable for electronic implementation? Y 30) Is it clear by what means a recommended action can be executed in an electronic setting, e.g., creating a prescription, medical order, or referral, creating an electronic mail notification, or displaying a dialog box? Y Comments: None Works Cited: AGREE Next Steps Consortium 2009. The AGREE II Instrument [Electronic version]. Retrieved , from http://www.agreetrust.org . Cabana, M.D. et al., 1999. Why Don’t Physicians Follow Clinical Practice Guidelines? A Framework for Improvement. JAMA: The Journal of the American Medical Association, 282(15), p.1458 -1465. Davis, D.A. & Taylor-Vaisey, A., 1997. Translating guidelines into practice: a systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines. CMAJ, 157(4), p.408-416. Field, M. & Lohr, K., 1990. Clinical practice guidelines: Directions for a new program. Grimshaw, J. et al., 1995. Developing and implementing clinical practice guidelines. Quality in Health Care: QHC, 4(1), p.55-64 Macintyre, P.E. & Schug, S.A., 2007. Acute pain management: a practical guide, Elsevier Health Sciences. Michie, S & Lester, K., 2005. Words matter: increasing the implementation of clinical guidelines. Quality and Safety in Health Care, 14(5), p.367 -370. Michie, Susan & Johnston, M., 2004. Changing clinical behaviour by making guidelines specific. BMJ, 328(7435), p.343 -345. Shiffman, R. et al., 2005. The GuideLine Implementability Appraisal (GLIA): development of an instrument to identify obstacles to guideline implementation. BMC Medical Informatics and Decision Making, 5(1), p.23. Bibliography: Greenes, R.A., 2007. Clinical decision support: the road ahead, Academic Press. Grossman, J.H. et al., 1990. Clinical practice guidelines: directions for a new program, National Academies Press. Guidelines, I. of M. (U S.) C. on C.P., Field, M.J. & Lohr, K.N., 1992. Guidelines for clinical practice: from development to use, National Academies Press. Macintyre, P.E. & Schug, S.A., 2007. Acute pain management: a practical guide, Elsevier Health Sciences. Palda, V.A., Davis, D. & Goldman, J., 2007. A guide to the Canadian Medical Association Handbook on Clinical Practice Guidelines. CMAJ, 177(10), p.1221-1226. Shiffman, R. et al., 2005. The GuideLine Implementability Appraisal (GLIA): development of an instrument to identify obstacles to guideline implementation. BMC Medical Informatics and Decision Making, 5(1), p.23. Teije, A. ten, Miksch, S. & Lucas, P., 2008. Computer-based medical guidelines and protocols: a primer and current trends, IOS Press. Turner, T., 2009. Developing evidence-based clinical practice guidelines in hospitals in Australia, Indonesia, Malaysia, the Philippines and Thailand: values, requirements and barriers. BMC Health Services Research, 9(1), p.235. Read More