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accounted for, make it difficult to determine whether the intervention and outcome are related. For example, if glucose control in patients receiving enteral vs parenteral nutrition is the outcome of interest, confounding variables such as diabetes, intra- venous dextrose, acuity, and BMI may also influence glucose control and should be collected and accounted for using regression analysis. If the baseline characteristics of the groups are similar or individuals with confounding variables are excluded, the researcher can also be more confident that the factor or intervention is truly related to the outcome.23


RCTs are less affected by confounding factors because these trials


are designed to use the principles of control, randomization, and replication. When key confounders are mitigated in an RCT through the use of rigorous eligibility cri- teria, the researcher can conclude from statistically significant results that there is a causal relationship between the intervention and outcomes. The limitations of these types of prospective studies are that they are typically expensive to conduct, may require a relatively large sample size, and can take longer to complete. New researchers should consider beginning their research experience with case


studies, case series (both of which are typically retrospective), or a cross-sectional study. Because electronic medical records are utilized in most clinical settings, re- trieval of lists of patients with a particular International Classification of Diseases (ICD-10) code or procedural code is more feasible. Nutrition managers and RDNs should collaborate with their information technology departments for assistance identifying patients of interest for the research. These studies are usually faster to complete and less expensive than RCTs or cohort studies, and they can be an effective way to gather the data about a population or group of patients needed to design a prospective trial. However, retrospective data collection can be hampered by selection bias, missing information from a database or medical record, or poor recall by study subjects. Box 12.5 on page 254 details a series of related study designs for research about enteral nutrition delivery among patients who are critically ill.


Outcomes Research Outcomes research focuses on maximizing the quality of care and is conducted at a practice site or in a real-world setting.25-27


Because outcomes research is not as


controlled as RCTs, outcomes research has lower internal validity (eg, cause-and- effect relationship between the independent and dependent variables) and higher external validity (eg, generalizability of the results to persons, settings, and times other than those used in the study) in comparison to RCTs. The outcomes studied can be clinical (eg, ventilator-free days, infectious complications, or mortality), func- tional (eg, quality of life or patient satisfaction measures), or economic (eg, cost of services). The aim of an outcomes study is to determine “the impact of an interven- tion on one segment of the sample (intervention group) compared with the impact on a segment of the sample not receiving the intervention (comparison or control group).”25


Because many variables in the practice setting can influence outcomes,


the “selected intervention should be one that can be tested realistically within the dietetics professional’s span of control and expected to show measurable difference if implemented.”19


Box 12.6 on page 254 guides you through the steps of an outcomes


project. The PICO (patient group, intervention, control or comparison group, outcome) format, which can also be used in RCTs, is recommended to organize your research question for an outcomes project.25


CHAPTER 12: Getting Involved in Research 253


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