Clinical guidelines assessment - Research Paper Example

?Running head: CLINICAL GUIDELINES ASSESSMENT Clinical Guidelines Assessment Insert Insert Insert 20 May Clinical Guidelines Assessment Clinical practice guidelines are well-structured and laid down procedures aimed at aiding the practitioner and patient to make informed decision regarding the suitable healthcare for specific clinical condition (Field & Lohr, 1990, P.38). The clinical guidelines are not decisions but are rather tools for assisting in making decision in clinical practice. Their principle focus is in improving the quality of healthcare provision by incorporating new research findings into the clinical practice through inclusion of specific recommendations, sufficient supporting evidence, a simple, and an attractive layout (Wollersheim, Burgers, & Grol, 2005). Application of the clinical practice guidelines has always produced mixed results due to various variables that affect the adoption of guidelines, thus a new approach to implementation of the guidelines should be adopted (Davis & Taylor-Vaisey, 1997). In order to address this problem, several approaches have been suggested including changing of clinical behavior by making the guidelines specific since it is difficult to get people to act on evidence based guidelines (Michie & Johnston, 2004). Further, writing guidelines composed of high behavioural specificity and simple English can be vital in increasing implementation of the guidelines (Michie & Lester, 2005). Additionally, to ensure that the knowledge contained in the guidelines reaches the target, an organized approach that integrates knowledge with workflow using existing electronic clinical decision support systems (ECDS) should be adopted (Entwistle, & Shiffman 2005). Currently, the most widely used clinical practices guidelines are the AGREE instrument (Appraisal of Guidelines for Research and Evaluation) and the GLIA system (GuideLine Implementability Appraisal). There are four principal steps involved in developing a clinical practice guideline: first, ‘selection of an appropriate topic; secondly, selection of the panel or group of people who will make the guideline decisions; additionally, collection and presentation of the information on which the guideline decisions will be made; lastly, the decision-making process itself’ (Pearson, & Stecher, n.d). The purpose of the AGREE instrument was to address the issues of variability in guide line quality, thus the AGREE instrument is a tool that is used to assess the methodological rigour and transparency in which a guideline is developed (AGREE Next Steps Consortium, 2009). The original AGREE instrument was revised giving birth to the new AGREE II instrument whose purpose is to provide a framework to: first, assess the quality of guidelines; secondly, provide a methodological strategy for the development of guidelines; and lastly, inform what information and how information ought to be reported in guidelines (AGREE Next Steps Consortium, 2009). According to AGREE Next Steps Consortium 2009, the AGREE II instrument is ‘composed of 23 key items organized within 6 domains, with each domain capturing a unique dimension of the guideline quality: Domain 1. Scope and Purpose is concerned with the overall aim of the guideline, the specific health questions, and the target population (items 1-3); Domain 2. Stakeholder Involvement focuses on the extent to which the guideline was developed by the appropriate stakeholders and represents the views of its intended users (items 4-6); Domain 3. Rigour of Development relates to the process used to gather and synthesize the evidence, the methods to formulate the recommendations, and to update them (items 7-14); Domain 4. Clarity of Presentation deals with the language, structure, and format of the guideline (items 15-17); Domain 5. Applicability pertains to the likely barriers and facilitators to implementation, strategies to improve uptake, and resource implications of applying the guideline (items 18-21); Domain 6. Editorial Independence is concerned with the formulation of recommendations not being unduly biased with competing interests (items 22-23).’ The AGREE II instrument is mostly likely to be used in addressing evaluation of quality issues being as part of an overall quality mandate aimed to improve health care, while GLIA is used to help appraise the Implementability of a clinical guideline (Shiffman, Dixon, Brandt, & et al, 2005). Using the AGREE II instrument evaluation are based on the six domains whereas for evaluation the GLIA several dimensions are used that include: Decidability, Executability, Effect On Process Of Care, Presentation & Formatting, Measurable Outcomes, Apparent Validity, Novelty/Innovation, Flexibility, And Computability thus their use can also be determined by the aspect one what to assess (Shiffman, Dixon, Brandt, & et al, 2005). In essence the AGREE II instrument is used in evaluating the quality of the clinical practices guidelines while the GLIA is used evaluate the Implementability of the clinical practices guidelines i.e. to check for any obstacles to implementation. Guidelines The three recommendations formulated in this paper and their GLIA instruments are based on the evidence statements found in the works of Macintyre et al., 2010. In this paper the global component in the GLIA instruments is not included since the evidence statements are not a complete guideline. Each evidence statement is accompanied by a number indicating the level of evidence as Macintyre et al., 2010 assessed and as shown in the table below. 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 Recommendation A combination of Paracetamol and Non-selective NSAIDS can be used to treat acute pain. They are best when the combination is used in incidences of adverse of pain. Evidence Paracetamol is an effective analgesic for acute pain; the incidence of adverse effects is comparable to placebo. (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) Non-selective NSAIDS given in addition to Paracetamol improve analgesia compared with Paracetamol alone. (Level 1) Non-selective NSAIDS and coxibs are effective analgesics of similar efficacy for acute pain. (Level 1) Coxibs are effective in the treatment of postoperative pain. (Level 1 Cochrane Review) GLIA Assessment: the structure used in the assessment that from Kashyap et al 2005, model. 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: Because the evidence suggest use of combination when Paracetamol is not achieving the desired effect. 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: The evidence should point to more conditions and other measures to enhance further evaluation incase it is needed. 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 Measurability 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 Novelty/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: The evidence clear point to situation in which the combination is more suitable 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 The recommendation does not give specific details on how the recommended action can be executed in an electronic setting. Recommendation Coxibs should be used as part of treatment in a clinical setting for the treatment of perioperative and post-operative acute pain. Caution should be exercised on the patients renal and cardiovascular complications. Evidence: Coxibs are effective in the treatment of postoperative pain. (Level 1 Cochrane Review) Coxibs to not appear to cause bronchospasm in individuals known to have aspirin-exacerbated respiratory disease. (Level 1) Preoperative coxibs reduce postoperative pain, and increase patient satisfaction. (Level 1) Coxibs and non-selective NSAIDS have similar adverse effects on renal function. (Level 1) Parecoxib and/or Valdecoxib compared with placebo do not increase the risk of cardiovascular adverse events after non-cardiac surgery. (Level 1) Coxibs and non-selective NSAIDS are associated with similar rates of adverse cardiovascular effects, in particular myocardial infarction; naproxen may be associated with a lower risk than other non-selective NSAIDS and celecoxib may be associated with a lower risk than other coxibs and non-selective NSAIDS overall. (Level 1) Use of parecoxib followed by valdecoxib after coronary artery bypass surgery increases the incidence of cardiovascular events and is therefore contraindicated. (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) 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? Y Comments: Especially on renal and cardiovascular 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 Measurability 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 Novelty/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. Recommendation Non-selective NSAIDs should be used only for post-operative pain relief and the perioperative prescription must be avoided. In addition, they should not be prescribed on patients with renal function and cardiovascular complications. Clinicians should be reminded of this preference by electronic mail when prescribing post-operative treatment. Evidence: Non-selective NSAIDS are effective in the treatment of postoperative and low back pain, renal colic and primary dysmenorrhoea. (Level 1, Cochrane Review) Coxibs and non-selective NSAIDS have similar adverse effects on renal function. (Level 1) Non-selective NSAIDS do not significantly increase blood loss after tonsillectomy but do increase to need for reoperation due to bleeding. (Level 1) Coxibs and non-selective NSAIDS are associated with similar rates of adverse cardiovascular effects, in particular myocardial infarction; naproxen may be associated with a lower risk than other non-selective NSAIDS and celecoxib may be associated with a lower risk than other coxibs and non-selective NSAIDS overall. (Level 1) Perioperative non-selective NSAIDS increase the risk of severe bleeding after a variety of other operations compared with placebo. (Level II) Coxibs do not impair platelet function; this leads to reduced perioperative blood loss in comparison with non-selective NSAIDS. (Level II) Adverse effects of NSAIDS are significant and may limit their use. (Clinical experience and expert opinion) 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) 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: None 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 Measurability 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 Novelty/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: Due to evidence of many preconditions before prescription of non-selective NSAIDS a reminder for through consultation before their prescription should be kept. Reference List AGREE Next Steps Consortium. 2009. The AGREE II Instrument. (Online). Available from: http://www.agreetrust.org (Accessed on 20 May 2011). 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, Vol. 157, No. 4, Pp 408-416. Entwistle, M, & Shiffman, R.N., 2005. Turning Guidelines into Practice: Making It Happen With Standards. Health Care and Informatics Review Online [HCRO]. (Online). Available from: http://www.openclinical.org/guidelines.html (Accessed on 20 May 2011). Field, M. & Lohr, K., 1990. Clinical Practice Guidelines: directions for a new program. Washington DC: National Academies Press. Kashyap, N., et al. 2005. GLIA: GuideLine Implementability Appraisal v. 2.0. New Haven: Yale Center for Medical Informatics. Macintyre, P.E., et al. 2010. Acute pain management: a practical guide. NY: Elsevier Health Sciences. Michie, S. & Johnston, M., 2004. Changing clinical behaviour by making guidelines specific. BMJ, Vol. 328, No.7435, Pp 343-345. Michie, S., & Lester, K., 2005. Words matter: increasing the implementation of clinical guidelines Qual. Saf Health Care, Vol. 14, Pp 367-370. Pearson, M. & Stecher, B., N.d. Clinical Practice Guidelines in the Health Sector. (Online). Available from: http://www.rand.org/pubs/monographs/MG136/MG136.ch6.pdf (Accessed on 20 May 2011) Shiffman, R.N., et al. 2005. The GuideLine Implementability Appraisal (GLIA): development of an instrument to identify obstacles to guideline implementation. BMC Med Inform Decis Mak, Vol. 5, No. 23. Wollersheim, H., Burgers, J., & Grol, R., 2005. Clinical guidelines to improve patient care. Neth J Med, Vol. 63, No. 6, Pp188-192. Read More