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Speaker Name : Jan Kottner

WORKSHOP: BASIC PRINCIPLES OF CLINICAL PRESSURE ULCER RESEARCH AND UTILIZATION Dr. Jan Kottner Clinical Research Center for Hair and Skin Science Department of Dermatology and Allergy, Charité-Universitätsmedizin , Germany. Declaration of Financial Interests or Relationships.

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Speaker Name : Jan Kottner

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  1. WORKSHOP: BASIC PRINCIPLES OF CLINICAL PRESSURE ULCER RESEARCH AND UTILIZATIONDr. Jan KottnerClinical Research Center for Hair and Skin Science Department of Dermatology and Allergy, Charité-Universitätsmedizin, Germany

  2. Declaration of Financial Interests orRelationships Speaker Name: Jan Kottner I have no financial interests or relationships to disclose with regard to the subject matter of this presentation.

  3. Learning objectives • At the end of this lecture, students will be able to: • describe basic principles of different research designs to evaluate pressure ulcer prevention/treatment research • discuss methods for research utilization in pressure ulcer prevention and treatment practice

  4. What is research?

  5. What is research? Questions Knowledge (theories) Research Answers - Books, papers - Seminars - Models - Maps - Digital data - Ideas, opinions - … - Experiments - Studies - Expeditions - Thinking - …

  6. Research desings • Study type • “The overall plan for addressing a research question, including specifications for enhancing the study’s integrity” (Polit, Beck 2008) • Everything begins with the question!!! Does the design fit to the research question?

  7. Secondary data-analysis Research desings Qualitative Quantitative Descriptive/ observational Experimental Systematic review Meta-Analysis More than one group Consensus techniques (Delphi, nominal groups) One group Interviews Randomized controlled trial Cohort (prospective) Focus groups Cross-sectional (one point in time) Hermeneutics Controlled trial Ethnography Case control (retrospective) N-of-1 trial Grounded Theory Quasi-experimental Diagnostic accuracy, reliability… Phänomenology

  8. Quantitative study designs Does the investigator assign exposures? Yes No Experimental study Observational study

  9. Quantitative study designs

  10. Case series • Description of consecutive set of cases • Usually from clinical practice Advantages • Important function in informing practice, research • Starting point for further research, hypothesis generating • Useful for rare conditions Disadvantages • Strong publication bias

  11. Case series

  12. Cohort studies • Prospective follow-up of one or more groups • Cohort: group of people who share a common characteristic Event Event Event Sample Event Event Event Exposed Event Event Event Non exposed

  13. Cohort studies

  14. Cohort studies

  15. Cohort studies Advantages • Identifies risks and predictors of (long-term) outcomes, incidence • Study of individual developments (compared to other developments) • Ethically safe Disadvantages • Expensive (but cheaper than RCTs) • Difficult to identify controls • Risk for confounding and bias • Long-term, large sample sizes

  16. Case-control studies • Retrospective • Patients with certain outcomes are selected Sample Outcome Exposed Outcome Non exposed Outcome Time

  17. Case-control studies

  18. Case-control studies Advantages • Quick and cheap • Data are already there (clinical records) • Hypothesis generating Disadvantages • Usually secondary data, no control over data quality • Difficult to identify controls • High risk for confounding and bias

  19. Cross-sectional • Investigation of a sample at one point/period in time • Sample should represent the population Sample Outcome Exposed Non exposed Time

  20. Cross-sectional

  21. Cross-sectional Advantages • Quick and cheap • Estimates disease load (prevalence) or procedures • Hypothesis generating • Ethically safe Disadvantages • Associations indicate no causality • Risk for confounding

  22. Randomized controlled trial (RCT) • Prospective follow-up of one or more groups • Active allocation to treatment and control groups • Random allocation • Concealed allocation, blinding • Standardized Sample Randomization I Baseline Outcome Baseline Outcome Time

  23. Randomized controlled trial (RCT)

  24. Randomized controlled trial (RCT) Advantages • Control of confounders • Highest probability to detect causality • Guides clinical decision making Disadvantages • Expensive • May be ethically problematic (e.g. control groups) • May not be generalizable

  25. Quasi experimental • Experiments missing certain criteria for RCTs, e.g. random allocation, prospective follow-up … Sample Randomization I Baseline Outcome Baseline Outcome Time

  26. Quasi experimental

  27. Quasi experimental Advantages • Probability to detect causality Disadvantages • Risk of bias and confounding • May be ethically problematic (e.g. control groups) • May not be generalizable

  28. Criteria for causality • Strengths of the relationship • Consistency of findings in different populations • Specificity (cause leads to a single effect) • Temporality (cause precedes effect) • Biological gradient (dose-response relationship) • Biological plausibility • Experimental evidence(Twisk 2003)

  29. Risk of bias • A systematic error or deviation in results or inferences from the truth • RCT is not automatically of high quality • How confident can we be, that study results are true? • Systematic evaluation of criteria critical for the study design and conduct (based on tools) • Risk of bias ≠ bias

  30. Risk of bias in RCTs Randomization Intervention delivery Patient retention Outcome assessment

  31. Excercise • You are responsible for PU management in your hospital. The process includes an assessment protocol and allocation of preventive measures (and many other aspects...) • The current risk assessment approach is insufficient and you are looking for an alternative • A collegue recommends a new risk assessment statregy but you don’t know whether this is better • Therefore you want to test this • What would you do and why?

  32. Research utilization • Use of research knowlede in practice • Translation of knowledge into real-world • Evidence - based practice/medicine/nursing .... • Evidence-based medicine… “… is 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.” (Sackett 1996)

  33. Evidence-based practice Legal / financial framework Internal evidence (Individual clinical expertise) External evidence (Studies, research results) Clinical decision making Patient values and expectations

  34. How to integrate external evidence?

  35. Guidelines • Clinical practice guidelines are systematically developed statements to assist practitioners and patient decisions about appropriate healthcare for specific clinical circumstances • Systematic aid for making complex decisions

  36. How to implement guidelines/a new procedure?

  37. Implementation

  38. Implementation (Grol & Grimshaw The Lancet 2003)

  39. Implementation Assess barriers and facilitators for guideline implementation at professional and organizational levels before implementing a pressure ulcer prevention initiative within the organization. (Strength of Evidence = C; Strength of Recommendation = )

  40. Implementation Assess knowledge and attitudes of professional staff regularly using validated assessment tools. (Strength of Evidence = C; Strength of Recommendation = ) At an organizational level, assess the availability, quality and standards for use of available equipment for the prevention and treatment of pressure ulcers. (Strength of Evidence = C; Strength of Recommendation = ) At an organizational level, review availability of and access to support surfaces and establishprotocols for procurementthat ensure timely access for individuals at risk of, or with an existing pressure ulcer. (Strength of Evidence = C; Strength of Recommendation = ) 

  41. Implementation Develop a structured, tailored and multi-faceted approach to overcome barriers and enhance facilitators for protocol implementation. (Strength of evidence = B; Strength of Recommendation = ) Consider optimizing work procedures at a professional level through the introduction of: • tailored staff education, • role models or designated wound care “champions”, • nurse-led quality improvement programs, and • cues to perform pressure ulcer prevention. (Strength of evidence = C; Strength of Recommendation = )

  42. Take home messages • The research design must fit to the research question • Interventional trials are best to evaluate effects (an causality) • Reduce possible sources of bias to a minimum • Combine external and internal evidence and patient preferences • Clinical practice guidelines are good summaries of the latest evidence • Use various strategies for implementing a change

  43. Contact Jan Kottner Charité-Universitätsmedizin Berlin Department of Dermatology and Allergy Email: jan.kottner@charite.de

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