In both scenarios, there is a significant reduction in the odds of the event with therapy and no statistical heterogeneity. If so, then studies in older patients or in settings where older patients reside, such as assisted-living facilities, will have greater applicability. Make Judgments About the Applicability of Individual Studies For each efficacy trial, clearly report characteristics that may limit applicability. Thus, the important question is not whether magnesium would benefit patients with a myocardial infarction but whether it would still provide benefit in addition to the standard medical therapy currently being used for acute myocardial infarction. Applicability data should be used to place the available benefits and harms literature in context. Thus, when evaluating studies comparing complication rates between surgical repair and other therapies, the setting where the studies take place is very important in determining applicability. Systematic Review Process Overview This slide illustrates the steps in the systematic review process. In step 2, judgments about whether a trial is an effectiveness or efficacy trial is made and then components that may negatively impact applicability are summarized in the “comments” column. Issues of validity and reliability in qualitative research | Evidence … If a study is conducted in a country or region where standards of care differ markedly from the setting of interest, applicability may be reduced. In contemporary practice, however, a large subset of patients undergo angioplasty with a drug-eluting stent. In heart failure trials, two-thirds of white patients have heart failure as a result of ischemic heart disease. Other Applicability Resources Many readily available sources of information can help determine applicability, including registry or epidemiologic information. The applicability of a trial’s results could be limited if patients represent only a small proportion of those being treated in normal practice.10 The participation of centres with different resources and surgeons with different skills may mean that treatment effects observed in research may not be applicable, or at worst are irrelevant, to non-research settings.11 12 13 14 15 Surgical … Burchett, PhD*, Susannah H. Mayhew, PhD, John N. Lavis, MD, PhD, Mark J. Dobrow, PhD *Department of Global Health and Development, Faculty of Public Health and Reference: Shadish W, Cook T. Experimental and quasi-experimental design for generalized causal inference . GRADE = Grading of Recommendations Assessment, Development and Evaluation. an example of applicability and transferability appraisal Table 3 illustrates an appraisal of the applicability of and transferability to the Chinese setting of behavioural interventions for the prevention of HIV/AIDS among men who have sex with men (MSM). Step 2. Setting and Applicability Setting refers to either the geographic setting or the clinical setting. ApplicationsTwo examples of a wide spread applicability of topographic maps, Remote Sensing and GIS data in high mountain environment are chosen to document the possibilities and limits of … References: Gartlehner G, Hansen RA, Nissman D, et al. These trials are not applicable to most patients who will be receiving this procedure in clinical practice. Intervention and Applicability: Examples Here are some examples in which the intervention negatively affected applicability. J Clin Epidemiol 2006;59:1040-8. http://www.ncbi.nlm.nih.gov/pubmed/16980143 Gartlehner G, Thieda P, Hansen RA, et al. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Descriptive research can be used to investigate the background of a research problem and get the required information needed to carry out further research. Step 1. If high levels of nonadherence, adverse effects, or lack of response are found, then this reduces applicability of the study results because better safety or superior efficacy will be seen versus the general population with the disease. Applicability Judged for Each Question Rather than judging the applicability generally for a project, applicability should be judged separately for each important question. Thus, applicability is reduced. Applicable results likely reflect the expected outcomes when the intervention is employed in clinical practice. In the first example, the benefits of breast self-examinations are being evaluated in Shanghai and St. Petersburg. In the second example, selecting patients who are more compliant and then instituting techniques such as pill counts, telephone reminders, and compliance incentives can overestimate the degree of benefit that a therapy can provide in clinical practice. Assessing Applicability Prepared for: The Agency for Healthcare Research and Quality (AHRQ) Training Modules for Systematic Reviews Methods Guide www.ahrq.gov. This suggests that applicability should be assessed separately from quality. Population and Applicability When most people think of applicability, they focus only on the population. Measurement. Note major applicability limitations of studies in the last column of the evidence tables and highlight effectiveness studies. In this example, we focus on the age of patients with a disease. We explore five areas so that we know what the population in the real world looks like, what interventions are currently used, what comparators are most relevant, what outcomes are of greatest interest, and in what settings care is delivered. Applicability of scientific method to legal research – article1000.com Most trials are efficacy trials, which maximize internal validity at the expense of applicability. For example, we may choose to use questionnaire items, interview questions, and so forth. Summary Table for Body of Evidence Applicability In this slide, we use the template for a summary table to assess the applicability of a body of evidence. First, identify beforehand a limited number of factors that are most likely to influence applicability of evidence for the specific issue being reviewed and report the relevant factors from individual studies. In the last example, bypass surgery and angioplasty are being compared. Some study-related factors alter the perceived balance of benefits to harms by selecting a population at low risk of experiencing harms or by using a run-in period to eliminate patients who would experience adverse events or become noncompliant before randomization. Which one the scientist uses, depends on the aims of the study and the nature of the phenomenon: For the comparator, the researcher first needs to evaluate the medication dose, schedule, and duration. For the intervention, describe the general characteristics of the interventions, how they compare to routine practice, and how this might affect benefits or harms. Transferability is established by providing readers with evidence that the research study’s findings could be applicable to other contexts, situations, times, and populations. In the Effective Health Care Program, the perspectives of clinicians, patients, and policymakers are usually considered. You can change your ad preferences anytime. Next, ascertain whether there was a run-in period and if so the reasons for attrition before randomization. As well as individual studies, a number of reviews of the extant literature where SCT has been applied are available. For example, if a new research paper concludes that smoking is not related to lung cancer, readers would be very skeptical because it disagrees with the weight of existing evidence. You may have a specific patient in mind when you search the literature, or you may have a more general question about types of patients with shared problems and what interventions are most effective for these types of patients. 1. Next, the demographics need to be reviewed. Step 3. In the population column, the population of interest, mean age, and New York Heart Association (NYHA) classification of disease severity are given. Which Series of Studies Has an Applicability Issue? Watchful waiting would be reasonable if the baseline treatment in both groups was standard medical therapy; unfortunately, this was not the case with our literature base, which limited applicability. However, in China and Russia, the use of other more-sensitive breast cancer-detection methods such as mammography is minimal. On the television series, “The Biggest Loser,” obese subjects are removed from their jobs and families and sent to a resort where physicians, dietitians, and personal trainers work with them on losing weight. Int J Technol Assess Health Care 2009;25:323-30. http://www.ncbi.nlm.nih.gov/pubmed/19619351 Thorpe KE, Zwarenstein M, Oxman AD, et al. Similarly, if the clinical setting differs markedly from that seen in the community (e.g., a specialty care setting), applicability is reduced. First, studies often do not report on factors needed to judge applicability. Differences in age, gender, race, or other important factors between the study population and patients in the community reduce applicability. The applicability of a seed ecological database (SEED) in botanical research - Volume 8 Issue 1 Skip to main content Accessibility help We use cookies to distinguish you from other users and to provide you with a better experience on our websites. As we will show in the next example, each individual study can have relatively low applicability in at least one aspect of PICOS, but the body of evidence can have high applicability. Unfortunately, these clinical trials, by and large, compared bypass surgery versus angioplasty with or without a bare metal stent. Credibility, validity, reliability and transferability, When to Select Observational Studies Quiz. Abstract. Increased use of CONSORT (Consolidated Standards of Reporting Trials) diagrams help to increase transparency in clinical trials, but deficiencies remain. In the second example, trials comparing magnesium to placebo in patients with acute myocardial infarction are included. A review of research and evaluation studies into IT in education shows us strengths and weaknesses. Reports should clearly highlight issues that raise important questions about applicability of individual studies in a “comments” or “limitations” section in evidence tables or in the text. Applicability refers to the process of evaluating a study and determining what specific people might benefit from the intervention. Studies conducted in large academic medical centers in major cities might not be as applicable to rural settings. With the use of a summary applicability table, it becomes easier for a reviewer to describe in the text how aspects of studies impact the interpretations of study results in answering a question. Applicability Resources In the Effective Health Care Program, clinical experts and stakeholders help ensure that the comparative effectiveness reviews are relevant to their constituencies. If the paper explained in detail how the research was carried out, other researchers would be able to repeat the research and either confirm or oppose the findings. In the third example, the regimen calls for iron to be given with zinc, which attenuates the ability of iron to raise hemoglobin levels. Finally, summarize the applicability of the body of evidence from multiple studies with respect to specific populations, interventions, comparisons, and outcomes. For example, trials conducted in tertiary medical centers with experienced surgeons performing a procedure after years of practice may not reflect the effects that would occur if this procedure were performed in smaller community hospitals. Are they mostly female, mostly elderly, mostly ethnic minorities? Meta-regression and/or separate applicability summary tables may help reviewers and those using the reports to see how well the body of evidence applies to the question at hand. In addition, the most applicable evidence may differ when considering a benefit or a harm. Understanding Perceptions of the Applicability and Transferability of Research Helen E.D. If the definition is markedly different than those used in clinical practice, then that negatively affects applicability. Determining how well the study population approximates the target population is critical to determining applicability. In the intervention column, the type of surgical procedure is described. If you continue browsing the site, you agree to the use of cookies on this website. Consider and Summarize the Applicability of a Body of Evidence From Individual Studies In contrast to Step 2, which is concerned with individual study evaluations of applicability, step 3 involves making the aggregate applicability for each component of the PICOS framework (i.e., population, intervention, comparators, outcomes, and setting) and the overall assessment of applicability. These questionnaire items or interview questions are part of the measurement procedure . example of unethical research is the experiment conducted between 1950-1952 in which more than 1,000 pregnant women were given diethylstilbestrol to prevent miscarriages. Effectiveness Trials Here we provide a tool for differentiating effectiveness trials from efficacy trials. Thus, in subsequent clinical trials, it appears that certain therapies, such as hydralazine with isosorbide dinitrate, work better in African Americans, but ß-blockers, such as metoprolol succinate and bucindolol, work better in whites. It is important also that the review should include some historical as well as contemporary material in order to put the subject being studied into context. -3, , research project manager in health technology assessment, , professorial research fellow in health services research, Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review, http://creativecommons.org/licenses/by-nc/2.0/, http://creativecommons.org/licenses/by-nc/2.0/legalcode, Government of Jersey General Hospital: Consultant in Older Age Psychiatry, The Morris House Group Practice: GP Teaching Fellow Post x2, Cornwall Partnership NHS Foundation Trust: Opportunities in Psychiatry, The Royal Surrey NHS Foundation Trust: Resident Consultant in Paediatrics with an interest in Oncology, The Royal Surrey NHS Foundation Trust: Resident Consultant in Paediatrics with an interest in Cardiology, Women’s, children’s & adolescents’ health. The AHRQ Training Modules for the Systematic Reviews Methods Guide: An Introd... No public clipboards found for this slide. Applicability Summary Table Template In this slide, we provide a template for summarizing the applicability for aggregated studies for each component of the PICOS framework (i.e., population, intervention, comparators, outcomes, and setting). So although the show can demonstrate the dramatic effect that lifestyle modification can have under optimal practice conditions, the applicability of this intervention for the average American is low. Defining Applicability Applicability is defined as the extent to which the results observed in published studies are likely to reflect the expected outcomes when an intervention is applied to broader populations under real-world conditions. In the third example — a general assessment of clinical trials used to inform Medicare decisions — patients enrolled in the clinical trials were younger and more often male than is typical of the Medicare population, thus reducing the applicability of the evidence gathered from these clinical trials. Finally, we learned that important limitations of the applicability of the evidence should be described within each summary conclusion. Individually, the studies might have limited applicability, but together the body of evidence is applicable. In the comparator column, the comparator is described, and then the extent of use of other medications already known to impact the disease process is identified. A simple and valid tool distinguished efficacy from effectiveness studies. In clinical practice, most patients are on higher doses of the comparator. Subgroup analyses suggest that benefits occur predominantly in those patients not receiving standard therapy, thereby exacerbating the limitations this places on applicability. Qualitative approaches have particular potential in psychiatry research, singularly and in combination with quantitative methods. There are two major issues that will be considered here. How Individual Studies Consider Applicability When judging applicability, there are several general considerations. Make and Report Judgments About Major Limitations to Applicability of Individual Studies In Step 2, make and report judgments about major limitations to the applicability of individual studies. Is the systematic review intended to inform Medicare? If this regimen is not reflective of clinical practice, then the applicability of the study is reduced. Example 4 (reference 54 in Annex 1 in the online Data Supplement). Determine and Report the Most Important Factors in PICOS Format In Step 1, first identify conditions that affect applicability for the topic at hand. placed individuals as a central focal point of research in the workplace (Gong et al., 2009). Completed Applicability Summary Table In this example, we enter data from our case study into the fields of the summary table. These trials were conducted in select, large, tertiary care medical centers and may not be applicable to other settings.”. Clipping is a handy way to collect important slides you want to go back to later. Clinical trials may provide evidence to answer a question about the applicability of a benefit but exclude patients with baseline risks of adverse effects. These limitations should be highlighted in the text or evidence tables under the heading “comments” or “limitations.” When describing these limitations, describe how important factors would affect applicability and the expected direction and magnitude of bias. A simple and valid tool distinguished efficacy from effectiveness studies. Second, judge limitations to the applicability of individual studies based on those factors. J Clin Epidemiol 2009;62:464-75. http://www.ncbi.nlm.nih.gov/pubmed/19348971. In step 1 of the process, data on factors identified a priori as being most likely to impact applicability are extracted for each study and entered in the table. For example, if several trials utilize a higher than average risk population but other trials do not, subgroup analyses can be conducted. Once you have the list, report these key factors and why they are important in the methods section. Step 3. Once this is done, features from individual studies that may affect applicability should be presented in evidence tables. Input from clinical experts and stakeholders and a review of current practices can help identify specific applicability issues. Participants were healthier, younger, thinner, and more adherent than typical women with osteoporosis. For our purposes, assume that four other studies were also available with similar PICOS domains. If the number of events in the control group, for example, is markedly higher than the community population, then the applicability is reduced because the study population is sicker than the general population. Nonlinear methods such as k nearest neighbor (kNN) QSAR 92 employ models based on chemical similarity calculations. Similarly, the use of surrogate end points such as blood pressure or cholesterol, instead of health outcomes such as myocardial infarctions and strokes, can weaken applicability. We state that the population and disease stage are representative of the United States population with heart failure and that the intervention is plausible. Factors influencing benefits and harms often depend on distinct physiologic processes, and studies available to help answer one question may not be applicable for evaluating other outcomes of interest. Measurement is the process of observing and recording the observations that are collected as part of a research effort. Finally, if the training and skill level of an intervention team exceed those of the general practitioners who would be performing the intervention in the community, then applicability is reduced. Start with a broad list in PICOS format (population, intervention, comparators, outcomes, and setting) and then select those that are really important and likely to affect applicability. Comparing the demographics of patients in a disease registry (age, gender, comorbidities, baseline medications) to those of patients in a clinical trial can be enlightening when assessing applicability. An example is estrogen receptor-positive breast cancer for which tamoxifen is effective versus other forms of breast cancer for which it is not. In the first example, a study of a new antidepressant compares its higher dose regimen to a low dose of its comparator. Credibility is present when the research results mirror the views of the people under study. In scenario 1, the studies are clustered around the higher age range. In clinical practice, most patients are on higher doses of the comparator. However, two-thirds of African Americans have heart failure as a result of long-standing hypertension. They were placed on etanercept. Now customize the name of a clipboard to store your clips. See our User Agreement and Privacy Policy. Outcomes and Applicability: Examples Here are two examples of how the outcomes used negatively affected applicability. If the disease prevalence is markedly different than in the community, then applicability is reduced. In general, we are interested in the applicability of evidence to a primary care population in the United States. This includes understanding the real-world context and how studies may differ from this context. As such, these data are not as applicable to clinical practice where patients with microcytic anemia are given iron supplementation without zinc. No harms were being evaluated. These women were subject to a double-blind study without consent. Here we consider two of major measurement concepts. In the fourth example, trials are conducted to evaluate the benefits and harms of carotid endarterectomy in patients at risk for stroke. Describe whether these outcomes reflect the most important benefits or harms. The use of composite end points can also lower applicability because it is not always clear which components of the composite end point are being affected and to what extent. Applicability. Boston: Houghton Mifflin; 2002. Finally, given the information on the PICOS domains, the judgment that this is an efficacy trial is made and limitations to applicability are delineated. Effectiveness trials are specifically designed to produce applicable results and should be highlighted. Reference: Slutsky J, Atkins D, Chang S, et al. Although the Consolidated Framework for Implementation Research (CFIR) has never been evaluated in a practical context, it appeared to be a suitable theoretical framework to guide an implementation process. 3Department for Evidence-based Medicine and Clinical Epidemiology, Danube University, Krems, Austr… Using an applicability summary table for major questions may be helpful. Effectiveness trials have greater applicability than efficacy trials and, in this method, meet at least five of the seven following criteria: Enroll a primary-care population Have less-stringent eligibility criteria Assess health-related outcomes instead of only intermediate ones Have a long study duration and clinically relevant treatment modalities Assess for adverse events Have an adequate sample size to assess minimally important differences from a patient perspective Use intention-to-treat analysis This is only for illustrative purposes and other authors, such as Thorpe et al. Next, the severity or the stage of illness needs to be evaluated. As such, investigators had to screen 54,000 patients to enroll 4,000 eligible patients. These factors strengthen applicability. Comparator and Applicability: Examples Here are three examples where the choice of comparator negatively affected applicability. Third, if monitoring practices or visit frequency is more intensive than that used in practice, applicability is reduced. The The general population will exhibit many more adverse effects than those elucidated in this trial, reducing the applicability of the harms information derived from the trial. However, we cannot be truly confident that the benefits seen in higher aged populations can be extrapolated to those in the low-to-moderate age range. However, most Americans cannot afford to leave their jobs and families for several months and devote all of their time and effort to lifestyle modification. Similarly, if there are several potential comparators, the researcher needs to determine whether a representative one or a substandard one (i.e., known either to have poorer efficacy or greater adverse events) was chosen. Research methodology provides us the principles for organizing, planning, designing and conducting a good research. Studies conducted in the United States may be more applicable to clinicians in the United States but less applicable in the developing world. First, assess the medication dose, schedule, and duration. Population and Applicability: Examples Here are some examples where the populations used in trials limited applicability. Interrater In the second example, it is known that hospitals performing large numbers of abdominal aortic aneurysm repair surgeries have lower short-term mortality rates. For outcomes, describe those most frequently reported and over what period of time. Key Messages (I) As shown in this modules, the PICOS (population, intervention, comparators, outcomes, and setting) framework is a useful way of organizing the contextual factors of interest. For setting, describe the settings in which the studies were conducted and the potential implications of using the intervention elsewhere. 2Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, Rockville, MD. This is especially true in diseases that afflict patients with lower compliance rates such as abusers of alcohol and drugs. Registries may provide information on how the populations in trials are different from the populations that would receive the intervention in actual practice. Fourth, employing versions of technology that are not currently in use, either because they are too new or because they are outdated, can reduce applicability. Similarly, if there is a continuum of baseline risk, meta-regression can be conducted. Only a small number of studies are designed with applicability in mind. The applicability of the definitions of hip OA in the present study was made operational as the ability to discriminate between hip OA and no hip OA, the ability to categorise the severity of hip OA, and the skills and tools needed to classify people according to the respective definitions (table 4). Domain applicability can also be determined based on chemical similarity. In a subgroup analysis, benefits were accentuated in patients not receiving standard medical therapy with ACE [angiotensin-converting enzyme] inhibitors and ß-blockers, thus limiting applicability. Since only patients tolerating therapy were randomized, the trial found a very low incidence of adverse events. The theory of planned behavior and its applicability in research. Table of Contents; Measurement; Measurement. In this case, a cohort study might be more applicable for that harm. Unlike benefits and harms data, applicability data do not have to be reviewed systematically. Implementing clinical practice guidelines (CPGs) in healthcare settings is a complex intervention involving both independent and interdependent components. Finally, the settings for the studies are large tertiary medical centers, which may overestimate the benefits of therapy in actual practice and accentuate the harms. It is critical to understand rigor in research. This study had acceptable diagnostic accuracy (sensitivity, 72%; specificity, 92%) and therefore was not considered to have overinterpreted the clinical applicability of its results. If you continue browsing the site, you agree to the use of cookies on this website. First, review the eligibility criteria and ascertain the proportion of screened individuals enrolled in the study. The eligible patients were younger, healthier, and more adherent to therapy than is typical of patients with osteoporosis, which would reduce applicability of the trial results to typical osteoporosis patients. Internal validity concerns are not altered by changes in perspective, but applicability is. If they exhibit adverse effects, they were excluded from being randomized into the trial.