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A process whereby research evidence, clinical knowledge, and reasoning are used to make decisions about interventions that are effective for a specific client(s) |
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Evidence-based practice includes: (4) |
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- Best research evidence – Clinical expertise – Patient values – Patient circumstances |
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the 5 parts of every epidemiological study |
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participants Exposure group Compariosn Group Outcomes Time |
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The RAMMbo* acronym: assessing study bias |
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Recruitment Allocation Maintenance Measurement Blind or Objective |
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the number of people with an outcome at a single point in time |
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the number of events (outcomes) in a period of time e.g., falls in the 2 yrs after an intervention |
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Continuous outcomes are usually... |
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functional measurments i.e. grip strength |
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Epidemiologic Evidence Patient Preferences Policy Issues Clinical Considerations |
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Hierarchy of Evidence of Treatment Effectivness (least-most) |
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Expert Opinion Case series/studies Case Control Studies Cohort Studies RCTs Critically Appraised Individual Articles Crtically Appraised Topics Systamatic Reviews and Meta-analyses |
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What are Descriptive Studies |
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Designed to describe occurence of disease or outcome by time, place and person |
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What are Analytic Studies |
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Designed to examine etiology and causal associations, include both experimental and non-experimental |
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Analytic Studies: Experimental |
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Assignment to intervention is controlled by the investigator. includes controlled and uncontrolled trials |
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Analytic Studies: Non-experimental |
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Assignment to intervention not under investigator control. includes: cohort, case-control, cross-sectional, and ecological studies |
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Analytic Studies: Experimental: Uncontrolled Trials |
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Experimental trials without control or comparison group |
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Analytic Studies: Experimental: Controlled |
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Trials with control groups. Unit of randomization can be individual or groups/communities. Include RCTs, Quasi-Randomized and Non-Randomized |
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Analytic Studies: Experimental: Controlled: RCT |
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Intervention allocated randomly. All participants have the same chance of receiving intervention |
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Analytic Studies: Experimental: Controlled: Quasi-randomized |
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-INtervention is under control of the researcher -study participants are not randomized -pre-post designs are th most commonly employed |
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Analytic Studies: Experimental: Controlled: Non-randomized |
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Allocation to treatment group is arbitrary (no underlying random process) |
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Analytic Studies: Experimental: Controlled: Non-randomized |
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Allocation to treatment group is arbitrary (no underlying random process) |
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Traditional, narrative reviews |
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usually written by experts in the field, are qualitative, narrative summaries of evidence on a given topic |
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Reviews in which there is a comprehensive search for relevant studies on a specific topic, and those identified are then appraised and synthesized according to a predetermined and explicit method |
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is the statistical combination of at least 2 studies to produce a single estimate of the effect of the healthcare intervention under consideration |
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involves obtaining raw data on all patients form eachof the trials directly and the re-analyzing |
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Steps in a systematic review |
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-Formulate the question to be addressed -Identify the criteria that will be used to select studies -Plan, implement, and disclose the literature search strategy -Identify relevant studies -Extract data form the selected studies -Analyze the extracted data -Draw conclusions based on the data |
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How are systematic reviews better? |
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-More objective -Literature search is comprehensive -Explicit criteria for choosing studies -Redears can replicate or verify the review |
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Why arent traditional, narrative reviews good enough? |
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-Can be subjective -Selective citation of literature -Usually uses vote-counting -Usually not quantitative -Redears cant replicate or verigy the review -Hard to separate research evidence form anecdotal experiences |
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What to look for in a systematic review |
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-Clearly defined, explicit question -Comprehensive and systematic search for studies -Assessment of quality of primary studies -Appropriate analysis and reporting of results -limitations and strength of evidence reviewed -interpretation supported by data -Implications for patient care and future research |
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-How likely the results are to be the "truth" |
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The importance and usefulness of the findings |
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-How well you can generalize the reuslts towards the general population -It is the degree to which we can make a causal inferences about the true effect of the treatment in the wider population. |
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Source population vs population of interest vs study sample |
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-Who we really want to say something about -Who the study represents -Who was actually studied |
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How to reach internal validity |
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By avoiding systematic errors in order to reduce bias |
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features of a study design, controlled by the researcher, that create differences between the two groups |
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-Any factor that acts to deviate the results away from the "truth" -Bias can lead to an over, or under, estimation of the true size of treatment effect |
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________ reduces bias by distributing unknown (or known) factors evenly across the study groups |
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-Refers to hiding the status of the participants' group assignment (treatment or control) from the participant, the reseracher, or both |
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-Refers to hiding assignment from both researcher and participant -can be hard to achieve with many "manual" intervention studies |
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T/F: When double-blind can't be achieved, assessments should not be conducted by the reseracher but by an independent evaluator |
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-occurs when there are safety issues or after all the data are collected |
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-Potential to be associated with both the exposure and the outcome -The estimate of the association between the exposure and the outcome must change when the potential confouder is controlled |
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-Both create false association between treatment and outcome (or mask true associations) -Confounders: 3rd factor, potentially controllable Bias: Systematic error, fatal flaw |
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-Respects the question of did the subjects stay in their original random assignments -Are people in the tx group actually getting the tx? |
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-the benefit of an intervention as compared to a control or standard program |
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-the benefits and use of the procedure under 'real world' conditions |
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Analytic studies: observational |
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-the research simply observes the participants at one point in time (cross-sectional) or over time (longitudinal) |
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Types of Descriptive studies (4) |
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-Prevelance surveys -Survelliance data -Case series -Registries |
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If observations are made looking forward they are called _______ |
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If observations are made from existing data they are called ______ |
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T/F: Randomization increases internal validity, reduces potential for bias |
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Characteristics of True Experiments (4) |
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-Exposures (independnet variables) are manipulated by the reseracher -Participants are randomly allocated -A control group is incorporated -cause & effect relationship |
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Types of Experimental Design (2) |
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Between-group Comparison Within-group Comparison |
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Types of Experimental Design: Between-group comparison (3) |
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- Pretest-postest control group design - Factorial design - Randomized block design |
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Types of Experimental Design: Within group Comparison (2) |
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- One way repeated measures design - Crossover design |
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Pretest- postest control group design |
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Single factor Two or more groups pretest establishes baseline |
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- include 2 or more independent variables - subjexts randomly assigned to various combination of levels of the two variables - two way factorial design (2x2) |
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- used when an extraneous factor might influence differences between groups |
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- one group of subjects is tested under all conditions and each subject acts as their own control |
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Half of the subjects received tx A followed by tx B, and the other half recieved tx B followed by tx A |
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The Well Elderly 2 study design is an example of a _______ Design |
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Advantages of within-group designs |
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- Ability to control for the potential influence of individual differences, such as age, gender IQ etc -Using subjects as their own control provides the most equivalent comparison group possible |
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Disadvantages of within-group design |
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-potential for practice effects or learning effect -carryover effects based on subjects being exposed to multiple treatment conditions. |
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-Researcher observes the intervention but does not control it Researcher observes but does not assign participants to – Active treatment group – Control or comparison group |
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-A type of retrospective observational study where people with a disease or condition are compared to people without the disease to see if they had different risk factors or exposures. -Objective: To identify variables that may predict the condition |
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Pros and cons of prospective studies |
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-Can identify “diagnosis” & confounders clearly at outset -Intervention can be more clearly documented -Temporal sequence of onset and outcome |
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Pros and cons of retrospective studies |
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- Data already available - Often involves largenumbers - Definitions may change over time - Follow-up times may be inconsistent |
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- Alcohol use as a risk factor for lung cancer can be confounded by smoking -alcohol and smoking can be confounders when examinng gambling as a risk factor for cancer |
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for a variable to be a confounder it has to meet the following conditions: |
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1. Relationship with the exposure 2. Relationship with the outcome even in the absence of the exposure 3. Not on the causal pathway 4. Uneven distribution in comparison groups |
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Controlling for Confounding (3) |
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– Randomization – Restriction (restricts admission to the study to a certain category of a confounder) – Matching (equal representation of subjects with certain confounders among study groups) can overcome a great deal of confounding. |
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Most Relevant Sources of Bias: Ascertainment Bias. |
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- Systematic error arising from the kind of individuals or patients that the individual observer is seeing. – Systematic error arising from the diagnostic process. |
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Most relevant sources of bias: Detection bias |
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The risk factor investigated itself may lead to increased diagnostic investigations and increase the probability that the disease is identified in that subset of persons |
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- A flaw in measuring outcome or exposure that results in differential accuracy of information between compared groups. – Many different biases (recall, reporting,measurement, withdrawal etc.) are collectively grouped in this class. |
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– Systematic error arising from inaccurate measurement (or classification) of subjects on the study variables. |
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– Caused by differences in accuracy of recalling past events by cases and controls. – There is a tendency for diseased people (or their relatives) to recall past exposures more efficiently than healthy people (selective recall). |
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– Unless the sampling method ensures that all members of the 'universe' or reference population have the same probability of inclusion in the sample, bias is possible. |
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– Non-respondents to a survey often differ from respondents. – Volunteers also differ from non-volunteers, late respondents from early respondents, and study dropouts from those who complete the study. – Also called response bias: systematic error due to difference in characteristics between those who choose to participate in a study and those who do not. |
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Common case control bias: |
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- Loss to follow-up (attrition) would be the greatest danger - Selection bias in retrospective studies |
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