Internal and external validity pdf
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- Against external validity
- What is Validity?
- External Validity and Model Validity: A Conceptual Approach for Systematic Review Methodology
- INTERNAL AND EXTERNAL VALIDITY IN CLINICAL RESEARCH
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Against external validity
Standard databases were searched for keywords relating to EV, MV, and bias-scoring from inception to Jan Tools identified and concepts described were pooled to assemble a robust tool for evaluating these quality criteria.
Improved reporting on EV can help produce and provide information that will help guide policy makers, public health researchers, and other scientists in their selection, development, and improvement in their research-tested intervention.
It is hoped that this novel tool which considers IV, EV, and MV on equal footing will better guide clinical decision making. External validity and model validity of study results are important issues from a clinical point of view.
From a methodological point of view, however, it appears that the concept of external validity and model validity is far more complex than it first seems.
As we begin to enter a time realizing the need for more mixed-methods designs and comparative effectiveness studies to be executed for making better informed health care decisions, the need for attention to some of these issues in evaluating study quality is imperative. Systematic reviews in health care generally assess the quality of experimental randomized clinical controlled trials RCTs.
These systematic reviews are designed to identify and appraise methodological bias in reports of RCTs and synthesize the research evidence relevant to a specific research question. Therefore, the results of systematic reviews are often applied for policy making in health care and often regarded as the strongest form of research evidence, becoming a crucial component in helping make accurate decisions about clinical care.
Nevertheless, the assessment of study quality in most health care systematic reviews is based on results weighted heavily according to internal validity. In , Moher and colleagues identified 25 scales and 9 checklists that had been used to assess bias of randomized trials [ 1 , 2 ]. More recently, in , Olivo and colleagues identified 21 scales that had been used to assess bias of randomized trials [ 3 ]. Note that, while the majority of these tools are scales, which become aggregated scores in systematic reviews, organizations such as the Cochrane Collaboration recommend that systematic reviews avoid aggregation.
In fact, according to the Cochrane Collaboration, the difficulty in assessing bias using scales and checklists is incomplete reporting by studies and subjectivity of assigning weights to scale categories.
That is, is randomization more or less important when compared to blinding? In addition, often, bias scales place greater importance in reporting methods rather than appropriately conducting research methodology [ 4 ]. It is possible that such scales limit the quality analysis of the majority of systematic reviews, especially when making clinical decisions about health care and how the information applies to real-world situations, including RCTs and nonrandomized studies.
We believe that study quality is a multidimensional concept. This review discusses the concept of study quality and how it relates to internal, external, and model validity. What is validity? Validity is the degree to which a result from a study is likely to be true and free from bias [ 8 ].
Interpretation of findings from a study depends on both internal and external validity. Generally in experimental clinical trials the effect of the intervention is measured based on outcomes estimated based on the persons who are enrolled in that trial.
Therefore, it can be concluded that a study possess internal validity if a causal inference also known as reciprocal relationship can be properly demonstrated using three criteria: 1 the cause precedes the effect in time temporal precedence , 2 the cause and the effect are related covariation , and 3 there are no plausible alternative explanation for the effect other than the cause nonspuriousness [ 9 ].
Hence, experimental research attempts to accomplish the above criteria by 1 manipulating the presumed cause and observing an outcome afterward treatment effect ; 2 observing whether variation in the cause is related to variation in the effect; and 3 finally, using methods during the experiment to reduce the plausibility of other explanations for the effect. However, it is difficult to meet the criteria for validity without defining A inferences about whether the causal relationship holds over variation in persons and measurement variables external validity and B the particular treatments and settings in which data are collected model validity.
It is believed that internal validity is a prerequisite for the external validity and efficacy and effectiveness exist on a continuum [ 10 , 11 ]. Without generalizability the true therapeutic effect of clinical trials cannot be assessed.
With that said, it is staggering how often external validity is neglected in the methodological considerations of health care research [ 11 , 13 , 14 ]. Dekkers et al. Therefore it is important to make a distinction between research finding of efficacy and effectiveness of an intervention for health care providers, policy makers, and other stakeholders. Hence, hypotheses and study designs of an effectiveness trial are formulated based on conditions of routine clinical practice and on outcomes essential for clinical decisions.
In , Gartlehner and colleagues reported that systematic reviews, including meta-analyses, were including bias assessment for efficacy trials and often ignoring assessment of effectiveness trials. They proposed and tested a tool that can assist researchers and those producing systematic reviews, as well as clinicians who are interested in the generalizability of study results, to distinguish more readily and more consistently between efficacy and effectiveness studies.
This tool tested the primary factors in generalizability including patient baseline characteristics e. The following literature review will discuss how internal validity and external validity are equally important in deciding the effectiveness of treatment both efficacy trials and effectiveness trials for a specific condition or population, and by neglecting external validity from the systematic review quality assessment process researchers significantly reduce the overall quality of systematic review results and interpretations for translation of the evidence into practice.
According to the classic study by Cook and Campbell, external validity is the inference of the causal relationships that can be generalized to different measures, persons, settings, and times [ 16 , 17 ]. External validity concerns the generalizability of study; that is, how likely is it that the observed effects would occur outside the study?
For this paper, we separate external validity into two separate terms: A external validity as the results to persons other than the original study sample the population of patients to whom the results should be generalizable to the target population and B model validity as the generalization of results from the situation constructed by an experimenter to real-life situations or settings generalizability across situations or settings, that is, practitioners, staff, facilities, context, treatment regimens, and outcomes.
External validity as defined by this paper is sometimes referred to as population validity and model validity is sometimes referred to as ecological validity. But why is external validity important? And why should we measure it? Therefore, in health care and public health research internal validity seems to be the priority today [ 19 ]. However, as research becomes more applied and pragmatic, we see a trend towards emphasizing and strengthening external validity in clinical studies [ 16 ].
For example, it is important to know not only that a health care intervention or program works under ideal conditions i. Model validity, which we are calling a subset to external validity, also known as ecological validity goes beyond the patient eligibility criteria and moves to the conceptual model involving etiology, setting, and practice characteristics.
In fact, often, the definition of external validity includes study generalization to population and setting. Jonas and Linde [ 20 ] discuss the differences between conventional and CAM and the conceptual systems being investigated.
Many complementary medicine practices, however, come from systems of medicine developed outside these standard assumptions of Western medicine. Therefore, it is important that the researcher considers the interaction of the research methods with the conceptual model being investigated.
The objective of the present review is to evaluate the current evidence base available in the literature regarding external validity and model validity and develop and apply this assessment tool to measure external validity and model validity in randomized and non-randomized research trials that can be used with standardly accepted internal validity tools that will become more sensitive to areas where the reductionistic model does not fit i.
Because external validity depends on a source population a. The source population is identified as those individuals in the general population who, on the basis of inclusion and exclusion defined domains, could be participants in the research study.
For example, the source population can be population of all male patients with the treatment of heart failure with spironolactone admitted to hospitals in the Northeastern part of the United States. The study population a. This is referred to as simple random sampling. For example, the study population now consists of male patients between the ages of 18 and 45 admitted to four hospitals in the North Eastern part of the United States who have a history of heart disease being treated with spironolactone for heart failure between the dates Jan 1, and Jan 1, This technique may look simple; however Dekkers and colleagues [ 11 ] describe it to be quite complicated:.
For instance, suppose a study exists on the effect of antihypertensive drugs in patients between ages 45 and 74 years, with diastolic dysfunction but without severe co-morbidity. There are several possibilities to define target populations for this specific study. One doctor might strictly want to generalize to persons in the age bracket 45—74 years. Is there any reason to believe that the effects of the therapeutic intervention are not generalizable to year-old patients?
Or to those who are 77 years old? Likewise, would the results not be generalizable to a year old? But where should this extension of generalizability stop? Next, the severity of co-morbidity might be perceived in different ways.
Should uncomplicated diabetes mellitus, treated with oral medication, considered to be a severe co-morbidity? And what about diabetes treated with insulin? It becomes clear that there is no single commonly agreed predefined target population for a given study. Participation, recruitment, and retention rates are highly variable.
Indeed, sample attrition is also viewed as a problem to generalizability. A separate attrition analysis is needed to explore whether there are any differences between dropouts and nondropouts in any risk factors or mediating variables.
Fernandez-Hermida and colleagues [ 21 ] also distinguish generalizability from applicability. They assessed three domains of external validity characteristics generalizability, applicability, and predictability GAP for 29 randomized trials that evaluated effects of universal family-based prevention programs on alcohol misuse in young people.
Lastly, they add predictability to their assessment. Their definition of predictability involves the extent to which study outcome measures relate to meaningful health or social outcomes i. Lastly, they formalize external validity under deliberately narrow definitions. Fernandez-Hermida et al. If self-selection is present in the recruitment of a sample or its retention in both control and experimental groups, external validity, specifically the degree of generalizability of study results, may be limited p [ 21 ].
Therefore, according to the above definition of source population, this can be problematic in conceptualization especially in RCTs that have been strictly defined by the eligibility criteria because a target population that perfectly fits the eligibility criteria will, by definition, still differ from the original study population with respect to geographical, ethnical, and temporal conditions. Each of these differences may affect each outcome of interest [ 11 ]. It is possible that a well-defined formalization of external validity can help facilitate its assessment.
One major threat is selection bias which is the effect of some selection factor of intact groups interacting with the experimental treatment that would not be the case if the groups were randomly selected.
According to Shadish et al. Consider why sampling statisticians are so keen to promote random sampling for representing a well-designed universe. Such sampling ensures that the sample and population distributions are identical on all measured and unmeasured variables within the limits of sampling error.
Notice that this includes the population label whether more or less accurate , which random sampling guarantees also applies to the sample. Key to the usefulness of random sampling is having a well bounded population from which to sample, a requirement in sampling theory and something often obvious in practice. Given that many well bounded populations are also well labeled, random sampling then guarantees that a valid population label can equally and validly be applied to the sample.
With purposive sample selection, this elegant rationale cannot be used, whether or not the population label is known [ 9 ]. Therefore, it is difficult to think how we can achieve generalizability using simple random sampling when conducting purposive sampling selection often used in experimental clinical and social science research Figure 1.
That is, if external validity can be in play at all, what good is our inference of the causal relationship to hold over variation in persons, settings, treatment variables, and measurement variables based on a singular random sample from a population. Shadish et al. They treat generalization of causal relationships from a single sample to unobserved instances as a matter of external validity—whether or not random sampling was used.
We would argue that without measurement of external validity in trials both efficacy and effectiveness studies we risk failing to translate research into public health practice [ 16 ].
A confounding factor also known as confounding variable is an extraneous variable in a statistical model that correlates positively or negatively with both the dependent variable and the independent variable. These factors include age, gender, educational levels, risk factor, life style, and environment. These factors often have impact on health status and so should be controlled.
What is Validity?
Published on May 1, by Pritha Bhandari. Revised on March 8, Internal validity is the extent to which you can be confident that a cause-and-effect relationship established in a study cannot be explained by other factors. In other words, can you reasonably draw a causal link between your treatment and the response in an experiment? Table of contents Why internal validity matters How to check whether your study has internal validity Trade-off between internal and external validity Threats to internal validity and how to counter them Frequently asked questions.
Jeffrey A. Am J Occup Ther ;43 6 — Research comparing the effectiveness of two treatments offers both strengths and weaknesses for occupational therapy. Although it is worthwhile to determine which of two treatments works best for a particular problem, methodological problems may arise that preclude a valid conclusion. To draw valid conclusions from research, criteria for internal validity and external validity must be satisfied. The two preceding articles in this issue are examples of studies that used between-groups experimental methodology to compare the effectiveness of two different treatments. This paper evaluates the above-mentioned studies on the basis of principles of internal and external validity.
External Validity and Model Validity: A Conceptual Approach for Systematic Review Methodology
In a multicenter study in France, investigators conducted a randomized controlled trial to test the effect of prone vs. The validity of a research study refers to how well the results among the study participants represent true findings among similar individuals outside the study. This concept of validity applies to all types of clinical studies, including those about prevalence, associations, interventions, and diagnosis. The validity of a research study includes two domains: internal and external validity. Internal validity is defined as the extent to which the observed results represent the truth in the population we are studying and, thus, are not due to methodological errors.
Published on May 15, by Raimo Streefkerk. Revised on December 22, When testing cause-and-effect relationships, validity can be split up into two types: internal and external validity. Internal validity refers to the degree of confidence that the causal relationship being tested is trustworthy and not influenced by other factors or variables. External validity refers to the extent to which results from a study can be applied generalized to other situations, groups or events.
The scandal is not, or not any longer, that the problem has been ignored in the philosophy of science.
INTERNAL AND EXTERNAL VALIDITY IN CLINICAL RESEARCH
By Dr. Saul McLeod , published The concept of validity was formulated by Kelly , p. For example a test of intelligence should measure intelligence and not something else such as memory. A distinction can be made between internal and external validity.
Standard databases were searched for keywords relating to EV, MV, and bias-scoring from inception to Jan Tools identified and concepts described were pooled to assemble a robust tool for evaluating these quality criteria. Improved reporting on EV can help produce and provide information that will help guide policy makers, public health researchers, and other scientists in their selection, development, and improvement in their research-tested intervention. It is hoped that this novel tool which considers IV, EV, and MV on equal footing will better guide clinical decision making.
PDF | Researchers often aim to make correct inferences both about that which is actually studied (internal validity) and about what the results.