31/08/2017 1 NUR5326 Quality, safety and clinical governance in nursing and health care management Lecture 7 â€“ Activating change through the translation of evidence 2 Learning outcomes ï‚§ Describe the concept and constituents of evidence based practice (EBP) ï‚§ Determine the levels of evidence as they relate to different study types ï‚§ Identify key elements of study characteristics and findings ï‚§ Determine how to identify the best available evidence for a clinical question 3 Overview ï‚§ This week provides a brief overview of EBP ï‚§ Covers key principles and techniques in understanding, identifying and utilising evidence to improve the quality and safety of health care 31/08/2017 2 4 What is EBP? Sacket, D.L., Rosenberg, W.M.C., Gray, J.A.M., Haynes, R.B., & Richardson, W.S. (1996). Evidence based medicine: What it is and what it isn’t. BMJ, 312, 71â€72. The conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. â€¦ expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patientsâ€™ predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research â€¦ into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. 5 Research to practice pipeline â€¦ awareness (and discrimination) of high quality research … [is] â€¦ the first large hurdle â€¦ [but] â€¦ becoming aware of and accepting the best quality research â€¦ [is] â€¦ insufficient. Not all clinicians will have or use the skills of bedside evidence-based practice, and even the well skilled will fail to implement intended changes fully. Hence, evidence-based practice should not just be concerned with clinical content but also with the processes of changing care and systems of care. (Glasziou & Haynes, 2005. doi:10.1136/ebn.8.2.36) 6 EBP â€“ contemporary conceptualisation Clinical expertise Best research evidence Patientâ€™s values and circumstances EBP ï‚§ Integration of the best research evidence with clinical expertise and the patientâ€™s unique values and circumstances ï‚§ Needs to be effective and timely 31/08/2017 3 7 EBP and clinical decision making Clinical decision Valid & relevant research evidence Consumer preferences & needs Available resources Clinical judgement & expertise ï‚§ Clinical reasoning â€“ Judgement, artistry, science and logic â€“ Discipline specific knowledge (derived from theory, research and experience), cognition (thinking skills) and meta-cognition (reflective selfawareness) ï‚§ Combines â€“ The results of well-designed research â€“ Clinical expertise â€“ Consumer preferences and needs â€“ Available resources 8 Why change? http://www.goalsandachievements.co.uk/blog/theâ€upsideâ€ofâ€change/ 9 Examples Hoffmann, T., Bennett, S., & Del Mar, C. (2013). Evidenceâ€based practice across the health professions (2nd ed.). Chatswood: Elsevier Australia. 31/08/2017 4 10 Another example ï‚§ Primary research used as a basis for the 2016 Heart Foundation â€˜Guideline for the diagnosis and management of hypertension in adultsâ€™ â€“ Among adults with hypertension but without diabetes, lowering systolic blood pressure to a target goal of less than 120 mm Hg, as compared with the standard goal of less than 140 mm Hg, resulted in significantly lower rates of fatal and nonfatal cardiovascular events and death from any cause (The SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. New England Journal of Medicine, 373, 2103-2016) 11 â€˜Discoveringâ€™ EBP ï‚§ Discovery, here, refers to â€˜a new awarenessâ€™ ï‚§ It is closely related to dissemination, but in reverse â€“ This is concerned with being the recipient/consumer of research evidence ï‚§ What are some examples? 12 Questions? 31/08/2017 5 13 Levels of evidence (NHMRC) I: Evidence from a systematic review of all relevant randomised controlled trials II: Evidence from at least one properly-designed randomised controlled trial III-1: Evidence from well-designed pseudo-randomised controlled trials (alternate allocation or some other method) III-2: Evidence from comparative studies (including systematic reviews of such studies) with concurrent controls and allocation not randomised, cohort studies, case-control studies, or interrupted time series with a control group III-3: Evidence from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel control group IV: Evidence from case series, either post-test or pretest/post-test 14 Levels of evidence (JBI â€“ effectiveness) 1: Experimental designs (a. Systematic review [SR] of RCTs, b. SR of RCTs and other study designs, c. RCT, d. Pseudo-RCTs) 2: Quasi-experimental designs (a. SR of quasi-experimental studies, b. SR of quasiexperimental and other lower study designs, c. Quasi-experimental prospectively controlled study, d. Pre-test â€“ post-test or historic/retrospective control group study) 3: Observational â€“ analytic designs (a. SR of comparable cohort studies, b. SR of comparable cohort and other lower level study designs, c. Cohort study with control group, d. Case-controlled study, e. Observational study without a control group) 4: Observational â€“ descriptive studies (a. SR of descriptive studies, b. cross-sectional study, c. Case series, d. Case study) 5: Expert opinion and bench research (a. SR of expert opinion, b. Expert consensus, c. Bench research/ single expert opinion) http://joannabriggs.org/assets/docs/approach/JBIâ€Levelsâ€ofâ€evidence_2014.pdf 15 Levels of evidence pyramid â€“ quantitative http://guides.library.vcu.edu/c.php?g=47766&p=298773 Cross-sectional studies Capacity to demonstrate causation Capacity to be affected by bias 31/08/2017 6 16 Random variation, bias and confounding ï‚§ Random variation (error) â€“ Occurs by chance alone ï‚§ Bias â€“ Caused by systematic variation (error) ï‚§ Confounding â€“ A systematic error when one or more variables (known or unknown) are causally associated with the outcome and non-causally associated with the â€˜predictorâ€™ or â€˜exposureâ€™ variable Exposure Outcome Third variable 17 Bias is any process, at any stage of inference, which tends to produce results or conclusions that differ systematically from the truth (Sackett, 1979) Random error Systematic error BIAS Selection bias Precision â€“ relative absence of random error Validity â€“ relative absence of systematic error or bias Information bias Confounding 18 Classic biases and confounders ï‚§ Biases â€“ Selection (sampling) bias, allocation bias , attrition bias â€“ Social desirability bias, measurement bias â€“ Placebo effect, Hawthorn effect ï‚§ Confounders â€“ Age, sex, socio-economic status, smoking status 31/08/2017 7 19 Types of studies â€“ observational (mainly detect associations) ï‚§ Cross-sectional â€“ Investigate the prevalence of a disease or condition (and associated factors) in a cross-section of the population at a point or period of time ï‚§ Case control â€“ Group comparisons (cases with the outcome of interest and matched controls without the outcome of interest), investigating association with earlier risk factors / conditions â€“ Longitudinal and retrospective ï‚§ Cohort â€“ Group comparisons (those exposed to a risk fac
tor / condition and those not exposed), investigating association the incidence of a disease or condition â€“ Longitudinal and prospective (can be historical, eg using existing data collections) 20 Case-control vs Cohort ï‚§ Case control study â€“ Groups differ only in relation to the presence of the outcome â€“ Look back to see whether or not they were exposed to risk Direction of inquiry Sample Cases (lung cancer) Is smoking linked to lung cancer? Controls (no lung cancer) Time Risk factors present Risk factors absent Risk factors present Risk factors absent Compare Investigator Population Direction of inquiry Exposed Not Exposed ? Outcome(s) ? Outcome(s) Time Sample (without outcome) Risk factor Investigator ï‚§ Cohort study â€“ Exposure is always measured earlier than the outcome â€“ May compare groups with or without the exposure or with different levels of exposure (eg wood smoke, pollen, EMR) 21 Types of studies (intervention) ï‚§ Quasi-experimental studies â€“ Example: Controlled before and after (CBA) studies ï‚§ Randomised controlled trial (RCT) â€“ Randomisation and blinding Randomisation SAMPLE Participants Time Direction of inquiry Intervention Control Outcomes 31/08/2017 8 22 Questions? 23 Levels of evidence pyramid â€“ qualitative Daly et al (2007): http://dx.doi.org/10.1016/j.jclinepi.2006.03.014 Sampling focused by theory and the literature, extended as a result of analysis to capture the diversity of experience Theoretical concepts guide sample selection, based on analysis of literature Sample selected to illustrate practical rather than theoretical issues Provides rich data on the views or experiences of one person 24 Systematic reviews (with or without meta-analysis) ï‚§ A systematic and comprehensive review of the research literature on a specific topic â€“ Typically (though not always) focus on randomised control trials â€“ Use criterion-based selection of relevant evidence and a rigorous appraisal of validity â€“ Include an objective or quantitative summary with resulting evidence-based inferences â€“ Often (though not always) combined with meta-analysis ï‚§ Meta-analysis â€“ Statistical combination of the results of multiple studies into one pooled value â€“ Can be a useful way of reducing random error and increasing precision â€“ Can be misleading unless it is performed in the context of a systematic review of the literature, to avoid systematic biases. 31/08/2017 9 25 Clinical vs statistical significance ï‚§ Raised last week â€“ evaluating impact â€“ Important when searching for evidence, too ï‚§ If not statistically significant, cannot be clinically significant ï‚§ Can be statistically significant, but not clinically significant â€“ Example: A reduction of 0.5 on a 10-point pain scale may be statistically significant in a large study, but is not clinically significant ï‚§ If statistically significant and clinically significant â€“ Study type is important, but so are verified or replicated outcomes from other studies â€“ Better are systematic reviews with meta-analysis â€“ Even better are clinical guidelines derived from multiple reviews with meta-analyses and other evidence 26 Clinical networks and evidence-based practice 27 Questions? 31/08/2017 10 28 Finding evidence ï‚§ EBP requires clinicians to review current literature for evidence-based information that demonstrates solutions to clinical problems ï‚§ Clinical question â€“ Aetiology/prevalence, diagnosis, prognosis, treatment/intervention, patient experiences or concerns ï‚§ Research literature â€“ Systematic search through publication databases (eg PubMed, CINAHL, PsychInfo) ï‚§ Grey literature â€“ Search for non-commercial publisher documents (eg Google, Australian Policy Online, Safe Work Australia, GreyNet International â€“ www.greynet.org) 29 Asking the clinical question â€“ PICO(T) ï‚§ Patient, population or problem â€“ eg Adolescents ï‚§ Intervention, risk factor or exposure â€“ eg Alcohol consumption ï‚§ Comparison (if relevant) â€“ eg Do not consume alcohol ï‚§ Outcome â€“ eg ED presentation ï‚§ Time-frame (optional) 30 Operators in literature searches George et al. (2014): http://dx.doi.org/10.2147/NRR.S63578 (adolescen* OR youth) AND â€¦â€¦ 31/08/2017 11 31 Conclusion ï‚§ Evidence is an activating force for practice change â€“ Often the trigger for practice change (reactive) â€“ Also the rationale for practice change (proactive) ï‚§ EBP requires clinicians to review current literature for evidence-based information that demonstrates solutions to clinical problems â€“ Need to be able to understand and interpret the evidence (basic statistical skills) ï‚§ Important to ask the right (clinical) question, to proactively and purposefully find the best evidence 32 References Buitrago-Lopez, A., Sanderson, J., Johnson, L., Warnakula, S., Wood, A., Di Angelantonio, E., & Franco, O. (2011). Chocolate consumption and cardiometabolic disorders: Systematic review and meta-analysis. BMJ, 343(d4488), 1-8. doi: 10.1136/bmj.d4488 George, G.S., Ferguson, L.A., & Pearce, P.F. (2014). Finding a needle in the haystack: performing an in-depth literature search to answer a clinical question. Nursing: Research and Reviews, 2014(4), 65-76. doi: 10.2147/NRR.S63578 Glasziou, P. & Haynes, B. (2005). The paths from research to improved health outcomes. Evidence Based Nursing, 8, 36-38. doi:10.1136/ebn.8.2.36 Hermanns, N., Kulzer, B., Ehrmann, D., Bergis-Jurgan, N., & Haak, T. (2013). The effect of a diabetes education programme (PRIMAS) for people with type 1 diabetes: Results of a randomized trial. Diabetes Research & Clinical Practice, 102(3), 149-157. doi: 10.1016/j.diabres.2013.10.009 Hoffmann, T., Bennett, S., & Del Mar, C. (2013). Evidence-based practice across the health professions (2nd ed.). Chatswood: Elsevier Australia. Lansdown, G.E. (2014). How clinical governance can be supported through evidence based practice. In Gottwald, M. & Lansdown, G.E. (Eds.), Clinical governance: Improving the quality of healthcare for patients and service users (pp. 117-141). Maidenhead: Open University Press. Liang, C., McClean, M.D., Marsit, C., Christensen, B., Peters, E., Nelson, H,H, & Kelsey, K.T. (2009). A population-based case-control study of marijuana use and head and neck squamous cell carcinoma. Cancer Prevention Research, 2(8), 759-768. doi: 10.1158/1940- 6207.CAPR-09-0048 National Heart Foundation of Australia (2016). Guideline for the diagnosis and management of hypertension in adults: 2016. Melbourne: National Heart Foundation of Australia. Sacket, D.L. (1979). Bias in analytic research. Journal of Chronic Diseases, 32(1-2), 51-63. Sacket, D.L., Rosenberg, W.M.C., Gray, J.A.M., Haynes, R.B., & Richardson, W.S. (1996). Evidence based medicine: What it is and what it isn’t. BMJ, 312, 71-72.