I want to test a wound treatment or educational program but I have no funding or resources, How do I do it? Implementing & evaluating wound research conducted using pre-experimental designs part I AAWC WocSpec Research Committee, Barbara M. Bates-Jensen, PhD, RN, Chair ABSTRACT What happens in a static group comparison/cross-sectional design: BACKGROUND  Research methodology determines the quality of the data collected in a study, it concerns how the design is implemented and specifies:  when and how often data are collected  development of data collection measures & instruments  who data is collected from (the sample)  how data are analyzed  how findings are presented.  Whether or not study results are really the result of the variable on the group under investigation in the study (internal validity) and not some other variable AND  Whether or not the study results can be expected to be the same with other groups of people (external validity) are issues that are addressed by methodology.  Research design is an important part of methodology. Study design is a part of research methodology but not the only part. PRE-EXPERIMENTAL METHODS  In general, a research design is the plan for the research study. The design guides when and how often to collect data, what data to gather and from whom, and how to analyze the data.  A research design refers to the type of study that will be conducted, whether it will be pre- experimental, quasi-experimental, or true experimental. PURPOSE: To provide information on how to evaluate and improve methodology of wound research conducted using pre-experimental designs. BACKGROUND: Research methodology is concerned with how a study’s design is implemented and how the research is conducted. Methodology determines the quality of the data generated by the study and specifies: when and how often data are collected, construction of data collection measures, who data is collected from, how data is analyzed, and how findings are presented. Study design is a part of research methodology but not the only part. METHODS: Pre-experimental studies include: case study design, static group comparison or cross sectional design, and one group pre-test/post-test design including longitudinal time series and panel designs. These designs are frequently concerned with answering questions using an experimental approach when resources are not available for conducting more rigorous experimental designs. We often use pre-experimental designs for description and thus we are concerned with how to answer questions such as: How many? How much? How efficient? How effective? How adequate? We present information on conducting static group comparisons and one group pre-test/post-test designs for wound research. Advantages and disadvantages and methods for increasing the strength of pre-experimental wound studies are outlined. CONCLUSIONS: Pre-experimental designs follow basic experimental steps but do not include a control group. Usually a single group is studied but no comparison between an equivalent control group is made. The aim of pre- experimental design is to evaluate the influence of a variable or to determine the influence of a variable on one group and not on another. Limitations of one group pre-test/post-test designs are that the approach provides a measure of change but cannot provide conclusive results. Weakness in static group comparison designs lies in the failure to examine equivalence of groups before the implementation of the wound treatment or educational program. Methods to improve the quality of wound research using pre-experimental designs include attending to: historical events that may have occurred between the pre-test and post-test, maturation changes in the subjects, difficulties with pencil and paper measures for pre-tests and post-tests, instrument changes/calibration, subject/wound selection biases. Static Group Comparisons or Cross Sectional Designs Some considerations to improve Static group comparisons or Cross sectional studies  Data is collected on relevant variables one time only from a variety of subjects  Data are collected all at the same time  Findings give a “snapshot” of variables in the study at one particular point in time  Findings reveal how those variables are represented in a cross section of the population  Uses existing groups, no random selection of participants, no random assignment to treatment or comparison groups, SO:  NO WAY to determine that the comparison and treatment groups are the same or equivalent at the beginning and thus, no way to insure that the findings are related to the wound treatment or educational program and not some difference that existed at the outset. Limitations How to make static group comparison/cross sectional designs stronger: Pre-experimental research designs: answer questions using an experimental approach when resources are not available for conducting more rigorous experimental designs are used to describe a variable often answer questions such as: How many? How much? How efficient? How effective? How adequate? follow basic experimental steps but do not include a control group usually involve study of a single group with no comparison between an equivalent control group The aim of pre-experimental design is to evaluate the influence of a variable or to determine the influence of a variable on one group and not on another. There are 3 pre-experimental research designs: 1. case study 2. static group comparison/cross sectional 3. one group pre-test/post-test (longitudinal time series and panel) X = Wound Treatment or Educational Program O 1 = Post observation measurement or Posttest R = Randomization Randomizing the subjects in the two groups allows for interpretation of differences between the groups on the posttest or post observation measurement as due to the wound treatment or educational program. Treatment GroupXO1O1 Comparison GroupO1O1 X = Wound Treatment or Educational Program O 1 = Post observation measurement or Post test  Cannot measure change  Cannot establish cause and effect  Increase chances of error  No control of independent variable  Difficult to rule out rival hypotheses  Static, time limited Treatment Group RXO1O1 Comparsion Group RO1O1 Add a Pre-test or Pre-observation measurement Treatment GroupO1O1 XO2O2 Comparison GroupO1O1 O2O2 X = Wound Treatment or Educational Program O 1 = Pre treatment or educational program observation measurement or Pretest O 2 = Post observation measurement or Posttest The O 1 pretest allows determination of any differences between the treatment and comparison group before the wound treatment or educational program is delivered so any difference in the posttest or post observation measurement is more likely to be related to the wound treatment or educational program. OR Randomize subjects to groups WOUND TREATMENT: Use a standardized research based wound assessment tool which includes a variety of wound characteristics to assess wound response. Determine and report reliability of the instruments used to collect the wound and patient response data. Include basic demographic information about the patients and basic information about the wounds. Include only one wound per patient. Have someone who doesn’t know about the wound treatment (blinded) evaluate the wounds. Select wounds/patients that are similar for both the treatment and comparison group. EDUCATION: Measure whether or not the education actually results in change in behavior. No one cares if a posttest shows more correct answers, this does not translate into using the knowledge to improve care delivery. Present data on the costs associated with the educational program: time, staff resources to present the education, technology required., etc. Present data on attendance at the program (100% attendance? 75%?)  2 groups are chosen; one gets the wound treatment or education and the other does not. A posttest or post observation measure is then determined to measure the difference between the 2 groups. There is no pre-testing, so any differences between the 2 groups before the study are unknown.