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Research alternatives  oct 22 final Research alternatives oct 22 final Presentation Transcript

  • Research Alternatives for Clinical Practice Mary P. Watkins, DPT, MS Faculty Emerita MGH Institute of Health Professions Boston, Massachusetts1 MP Watkins, 2008
  • Course Objective And Goals  To define and explore methods for integrating research activities and clinical practice for the purpose of achieving effective, timely patient or client care.  To assure that our clinical intervention strategies – Are based on the best available research- based evidence 0R – Are lacking in that evidence therefore requiring studies to determine effectiveness – the beginnings of establishing sound evidence2 MP Watkins, 2008
  • Identify The Question Define the problem Identify the variables ? Characteristics that can be manipulated (intervention)or observed (measurement of outcome) MP Watkins,2008
  • What about all that information that already exists? How can we access it? What can we learn from it?4 MP Watkins, 2008
  • Evidence Based Practice The PICO Model The Search for Evidence5 MP Watkins, 2008
  • Introduction :  Definition of the PICO Model  A case example  Asking the question  Planning the Search6 MP Watkins, 2008
  • What does PICO represent:  P – The patient or the disease process  I – The intervention – Diagnostic test – Intervention  C – A comparison of interventions  O – The outcome7 MP Watkins, 2008
  • An example: Read this carefully: Mrs. C.T. aged 45 years old administrative assistant who complains of pain and tingling in her right hand, often waking her up during the night. The pain bothers her if she works at the computer for more than 20 minutes without a break. Her husband is unemployed at this time. She has accumulated two weeks of sick time. She has had the appropriate diagnostic tests revealing that she has carpal tunnel syndrome. Given her present symptoms, her need to work and the sick time limit that she has, we need to consider the treatment approach.8 MP Watkins, 2008
  • The Patient  45 years old  Employed and needs to be  Symptoms bother her at night and on the job  She has 2 weeks of sick time  On questioning, her goal is to be able to work without pain and tingling9 MP Watkins, 2008
  • Intervention  Work station evaluation and adaptation  Splinting  Work rest periods with exercise  Surgery10 MP Watkins, 2008
  • Comparison  Conservative program: splinting, rest periods, work station adaptation, exercise (alone or in combination) OR  Surgical intervention: arthroscopy or open approach11 MP Watkins, 2008
  • Outcome: ????  Conservative intervention – Effective to achieve the goal – Risk: eventual surgery  Surgical intervention – Effective to achieve the goal – Risk: Surgical failure; time lost from work12 MP Watkins, 2008
  • What is our specific question? For patients who have a confirmed diagnosis of Carpal Tunnel Syndrome and whose symptoms at this time limited to pain and tingling, is conservative management effective in reducing pain and increasing function? Is it complete? •The patient and the condition •The intervention •The comparison (may or may not include in our search) •The outcome13 MP Watkins, 2008
  • Identify The Question Define the problem Identify the variables ? Characteristics that can be manipulated (intervention)or observed (measurement of outcome) MP Watkins,2008
  • How will you pursue the answer to your clinical question? Is your question complete enough to pursue? YES? Let’s see what our choices are:15 MP Watkins, 2008
  • Existing Information http://servers.medlib.hscbklyn.edu/ebm/2100.htm16 MP Watkins, 2008
  • Systematic Review Definition: a process of summarizing research evidence in an organized, rigorous way to answer a clinical question.17 MP Watkins, 2008
  • The process of Systematic Review 1. Refine a specific clinical question 2. Identify and obtain all relevant studies 3. Establish inclusion criteria 4. Systematically select studies that meet the criteria 5. Appraise the methodological quality of selected studies 6. Synthesize the data to answer the question18 MP Watkins, 2008
  • The Systematic Review Process Develop the Conduct a database Retrieve relevant Clarify the need: Write protocol: identify search and review papers (4.0) out a question that variables, other relevant defines the information inclusion/exclusion sources (3.0) needed to arrive at an criteria and answer (1.0) evaluation method (2.0) Develop a search strategy (3.4) Identify the first Identify choice site Select and resources that (Repeat until all organize key include relevant resources have words information (3.1) been (3.3) included)(3.2) Sort and select Incorporate Information into a Evaluate the quality papers that meet synthesis of the systematic of the studies (6.0) established criteria. review (7.0) (5.0)19 MP Watkins, 2008
  • Potential Problems 1. Selection bias 2. Selection of inclusion criteria subjects method operational definitions20 MP Watkins, 2008
  • Meta-analysis Definition: statistical analysis of information from a series of similar studies Purpose: to synthesize and integrate findings into an overall interpretation of results Benefit: effectively increases sample size = increases power and generalizability21 MP Watkins, 2008
  • 1. What if the supporting evidence is not sufficient or does not exist at all?? 2. What if in our clinic there are several patients with a similar condition? 3. Time to consider conducting clinically-based studies…What are our reasonable choices??22 MP Watkins, 2008
  • What about one of these categories? http://servers.medlib.hscbklyn.edu/ebm/2100.htm23 MP Watkins, 2008
  • Case Report Purpose: • to describe something new or unique • to present usually ONE instance (one patient) • to perform an intense analysis of one case24 MP Watkins, 2008
  • Case Report  Introduction including background literature to support elements of the case and what’s unique about the case  Patient description: problem, symptoms, prior treatment,….  Methods – Treatment plan and procedures (Intervention) – Documentation methods (Measurement)  Discussion with compare/contrast to prior background, conclusion including future directions25 MP Watkins, 2008
  • Sequential Clinical Trials Purpose: to compare 2 treatments26 MP Watkins, 2008
  • Sequential Clinical Trials Advantages: 1. continuous analysis as data are collected 2. the method is a statistical technique27 MP Watkins, 2008
  • Sequential Clinical Trials: Concept and Technique  Alternative treatments administered randomly to pairs of subjects - a series of “little experiments”  Success criterion (“preference”) - determined apriori28 MP Watkins, 2008
  • Possible Outcomes Outcome Treatment A Treatment B Preference 1 Improvement Improvement None 2 No improvement No improvement None 3 Improvement No improvement A 4 No improvement Improvement B29 MP Watkins, 2008
  • Sequential Clinical Trials: TemplateBoundary A Boundary B30 MP Watkins, 2008
  • Sequential Clinical Trials: the “numbers problem”  Minimum # in the example: 8 pairs – What about the pairs with no preference?  Maximum # : 58 pairs to reach either favorable choice WHAT TO DO? – Record and account for tied pairs – Early termination: a clinical decision and a decision based on the Research Question!!31 MP Watkins, 2008
  • Sequential Clinical Trials: Example32 MP Watkins, 2008 © Michlovitz, 1990
  • Sequential Clinical Trials: Advantages  Data analysis is simple  The study is terminated as soon as a preference is determined  the impact on clinical decision-making can be immediate33 MP Watkins, 2008
  • Single case experimental designs Purpose: to compare 2 or more treatments (or treatment-no treatment)34 MP Watkins, 2008
  • Single case designs  Advantage - study of individuals (where individual characteristics may get lost in group studies)  Disadvantage - generalizability, but fosters replication35 MP Watkins, 2008
  • Single case experimental designs Unique elements:  Repeated measures of a “target”behavior  Design phases over time - beginning with “baseline”- usually designated by letters, e.g. A,B,C…..36 MP Watkins, 2008
  • Baselines….Definition of stability © P & W Figure 12.2, 200937 MP Watkins, 2008
  • Single case designs: A - B A B © P & W Figure 12.1, 200938 MP Watkins, 2008
  • Single case designs: A - B - A A B . . A . . . . . . . . . . . . . .39 MP Watkins, 2008
  • Multiple single case designs  alternate treatment: A - B - A - C  interactive treatment: A - B - BC - A  multiple baseline across subjects  staggered baseline  multiple dependent measures40 MP Watkins, 2008
  • Data Analysis  Visual analysis: stability and trend  Split middle technique - celeration lines Two standard deviation band method.41 MP Watkins, 2008
  • 20 18 16 14 Target Behavior A 12 10 8 6 4 2 0 1 3 5 7 9 11 13 15 17 19 20 Treatment Sessions 16 Target Behavior 12 8 C B 4 0 1 2 3 4 5 6 7 8 9 10 Sessions 20 16 Target Behavior Fig. 12.14 E 12 D E 8 4 0 1 2 3 4 5 6 7 8 9 10 Sessions © Figure 12.12 Portney & Watkins42 MP Watkins, 2008
  • 43 MP Watkins, 2008 © Figure 12.13 Portney & Watkins, 2009
  • Example To compare the effectiveness of two taping methods for treatment of plantar fasciitis for pain, disability and activities of daily life.44 MP Watkins, 2008
  • 2 standard deviation band analysis Mean & standard deviations were calculated for each phase  Lines were drawn 2SD above & below the mean & extended into the successive intervention phase  Where at least two successive data points fell outside the 2SD band, changes were considered significant45 MP Watkins, 2008
  • 46 10.5 A 56.5 B A C 4 1 5 LowDye Double X 70 0 0 0 600 0 0 500 0 0 Scores 0 0 0 40 4 8 12 Pain 302 0 2 200 0 0 0 0 0 10 16 48 64 14 0 12 26 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Days46 MP Watkins, 2008
  • Summary To define and explore methods for integrating research activities and clinical practice. – We reviewed the principles of evidence based practice to use the best available research- based data and the approach of systematic review – We considered kinds of studies that are suited to clinical practice and that contribute to the process of establishing sound evidence of effective, timely patient care.47 MP Watkins, 2008
  • Web- based References  Atkins C, Sampson J. Critical Appraisal Guidelines for Single Case Study Research. Available at: < http://is2.lse.ac.uk/asp/aspecis/20020011.pdf > Accessed September 12, 2008.  Aldridge J. Single Case Research Designs for the Clinician. Available at: < http://www.musictherapyworld.net/modules/archive/stuff/papers/Sing Case.pdf > Accessed September 12, 2008  Greenhalgh, T. How to read a paper: Papers that summarise other papers (systematic reviews and meta-analyses). Available at: < http://www.bmj.com/cgi/content/full/315/7109/672 > Accessed September 12, 200848 MP Watkins, 2008
  • Text References  Law M, MacDermid J. Evidence-Based Rehabilitation. Thorofare, NJ: Slack Inc, 2008  Portney LG, Watkins MP. Foundations of Clinical Research. Applications to Practice. Upper Saddle River, NJ: Pearson Prentice Hall, 200949 MP Watkins, 2008