- Methodology article
- Open Access
Contrasting groups’ standard setting for consequences analysis in validity studies: reporting considerations
© The Author(s) 2018
Received: 25 October 2017
Accepted: 15 February 2018
Published: 9 March 2018
The contrasting groups’ standard setting method is commonly used for consequences analysis in validity studies for performance in medicine and surgery. The method identifies a pass/fail cut-off score, from which it is possible to determine false positives and false negatives based on observed numbers in each group. Since groups in validity studies are often small, e.g., due to a limited number of experts, these analyses are sensitive to outliers on the normal distribution curve.
We propose that these shortcomings can be addressed in a simple manner using the cumulative distribution function.
We demonstrate considerable absolute differences between the observed false positives/negatives and the theoretical false positives/negatives. In addition, several important examples are given.
We propose that a better reporting strategy is to report theoretical false positives and false negatives together with the observed false positives and negatives, and we have developed an Excel sheet to facilitate such calculations.
Historically, surgery was learned by practicing on patients. To some extent, this is still the practice today. Simulation training enables practice and learning on a simulator before treating patients. Pushing the trainees up the learning curve before operating on patients leads to better outcomes . There is an increasing number of simulators available today to facilitate such a process. However, validity evidence behind well-intentioned simulation training programs and interventions are crucial to ensure training that is relevant to clinical practice. Increasingly, efforts are made to provide such validity evidence: number of publications with validity assessments of surgical simulators have increased to 70–90 studies/year in years 2014–2016 from approximately 30 studies/year in years 2008–2010 .
In the contemporary validity framework by Samuel Messick, validity of a construct is explored from five sources . One such source is the consequential validity, which explores the potential and actual consequences of a defined standard or a test. In our systematic review of current trends in validity studies, we found that consequential validity was explored the least of the five sources . Based on such findings [4, 5], we think that attention needs to be given to consequential validity to facilitate its use.
Surgical education is moving away from time-dependent learning to competency-based learning. Competency-based learning ensures certification of the trainees with satisfactory levels of performance, skills, and knowledge . An important issue in competency-based learning is the establishment of a competency standard that discriminates the trainees based on a defined level of competence. A standard is a score or a level of competency needed for a particular purpose and a standard can be a score needed to pass a test .
There are several methods to set such standards. The standard for when a certain level of expertise is reached is set by identifying cut-off points on different measures of performance, which can be rating scores or simulator metrics. One approach is the contrasting groups’ method that is a participant-based method where performance of a certain procedure is evaluated between participants of different expertise levels, e.g., novices and experts. In a study aimed at setting pass scores for surgical tasks using Objective Structured Assessment of Technical Skill, Montbrun et al. demonstrated that contrasting groups identify cut-off points at levels that are similar to those identified using other methods (i.e., borderline group and borderline regression) and provided evidence of consistency across the different methods .
If we consider a study with two groups defined by different levels of expertise, e.g., novices and experts; the false positives are defined as novices who score higher than the pass/fail score and pass the test, and the false negatives are defined as experts who score lower than the pass/fail score and fail the test. Traditionally, these false positives and false negatives are calculated based on the observed number of individuals who passes or fails a test.
In this paper, we discuss reporting considerations when using contrasting groups for standard setting. We demonstrate that the small number of participants in validity studies make consequential validity analyses very sensitive to outliers, which is a phenomenon with important implications for how we collect and interpret validity evidence. We propose that theoretical false positives and false negatives should be reported in addition to observed false positives and false negatives. Finally, to facilitate consequential validity analyses in future validity studies, we have developed an Excel sheet which can determine the pass/fail score when group-specific descriptive statistics are given (mean, standard deviation, group size) (Additional file 1). The Excel sheet can also calculate the theoretical false positives and theoretical false negatives.
We constructed a score distribution of the novices using the extracted mean and standard deviation, and used the probability of the random variable X being more than the pass/fail cut-off score to calculate the theoretical false positives (Fig. 2). We constructed a score distribution of the experts using the extracted mean and standard deviation, and used the probability of the random variable X being less than the pass/fail cut-off score to calculate the theoretical false negatives (Fig. 2).
To ease the conduct and reporting of contrasting groups analyses, we developed an Excel sheet which is available as a supplementary material to this paper (Additional file 1). Using group-specific mean, standard deviation, and number of participants, the Excel sheet automatically calculates a pass/fail cut-off as well as theoretical false positives and theoretical false negatives. The Excel sheet is also used for the examples provided in the results.
None of the studies examined reported theoretical false positives and theoretical false negatives as defined in the present paper [6, 10–26]. The following interesting examples illustrate how small groups in validity studies make the observed false positives and observed false negatives sensitive to the outliers of the distribution curve.
All data extracted from studies examined in this paper. In addition, we have calculated theoretical false positives (FP) and theoretical false negatives (FN) and provided the absolute difference between observed and theoretical FP and FN.
Number of novices
Novices’ score, mean (SD)
Number of experts
Experts’ score, mean (SD)
Pass/fail cut-off score
Novices passed (observed FP), n (%)
Calculated theoretical FP, %
Absolute difference in FP
Experts failed (observed FN), n (%)
Calculated theoretical FP, %
Absolute difference in FN
Data only available for one group
No numbers on pass/fail
No numbers on pass/fail
Data only available as median and range
Did not use contrasting groups
No numbers on pass/fail
No numbers on pass/fail
The contrasting groups’ standard setting method is commonly used for consequences analysis in small-sized validity studies. Here, we demonstrate that the observed false positives and observed false negatives are very sensitive to small samples and outliers. We argue that theoretical false positives and theoretical false negatives should be provided in addition to the observed false positives and observed false negatives. However, it should be noted that the theoretical false positives and theoretical false negatives are based on mean and standard deviation of the same small samples; hence, it cannot solve a problem of small samples in a study, but may provide an important addition to considerations on false positives and false negatives in consequences analyses.
The passing score can be moved from the intersection point between the two normal distributed curves if there is a greater concern of either passing non-competent participants or failing competent participants . When having such considerations, information of both observed and theoretical false positives and false negatives should be considered. These considerations are essential when setting standards and can be used actively to set a pass/fail score that fits with the rate of false positives and false negatives. One limitation of this paper is that we have not described details of cases where it may be relevant to move the passing score from the intersection point to address other needs, e.g., if a certain level of sensitivity or specificity is of interest. Such cases may benefit from receiver operator curve-based analyses [26, 27].
The differences between the observed and the theoretical false positives and false negatives should be reduced as the group samples are increased. In studies with large groups, the value of providing theoretical false positives and false negatives in addition may be limited since the distribution more closely will resemble the normal curve and the differences between observed and theoretical false positives and false negatives would be small. However, providing theoretical false positives and false negatives may still be relevant to underline the conclusions of such studies.
Using the contrasting groups’ method requires two groups defined by clear differences in expertise, i.e., novices who are not supposed to pass the test and experienced individuals who a priori should all pass the test. Collecting a sizeable group of non-competent performers can be a challenge, especially in a clinical environment where obvious ethical reasons do not allow complete novices to practice on patients. For example, in the Montbrun et al. study of technical performance by surgical trainees, the authors were unable to use calculations based on contrasting groups in some cases because of too few individuals in the novice/incompetent group . In such cases, borderline-based methods are more feasible, but this method often requires big sample sizes before ‘enough’ trainees are judged as borderline. One can also argue that identifying groups at the border of passing can be a challenging endeavor, e.g., a judge that is unfamiliar with the technique is more likely to judge a participant as a borderline which introduces an assessor bias . Therefore, using contrasting groups can be more feasible in some cases and especially in simulation-based studies where it is safe and ethically sound to let a novice group perform procedures without supervisor interference. It is important to remember that there are no general rule to which method to use, instead the most appropriate method may differ from one study to another based on the purpose of the individual study .
Based on the considerations made in this paper, we recommend reporting theoretical false positives and theoretical false negatives in addition to the observed false positives and observed false negatives in the consequences analyses of validity studies on standard settings using the contrasting groups’ method. This approach may strengthen the consequences analyses, especially when group sizes are small. To facilitate this, we have developed an Excel sheet to ease the conduction and reporting of contrasting groups analyses, which is available as a supplementary material to this paper (Additional file 1).
The authors received no financial support for the research, authorship, and/or publication of this article.
Availability of data and materials
All data generated or analyzed during this study are included in this published article and its Additional file 1.
YS and LK conceptualized the idea. MJ and YS analyzed and interpreted the data and prepared the manuscript. MJ and YS drafted the manuscript. All authors critically revised the manuscript for important intellectual content. All authors approved the final manuscript.
Ethics approval and consent to participate
Consent for publication
The authors declare that they have no competing interests.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Thomsen AS, Bach-Holm D, Kjærbo H, Højgaard-Olsen K, Subhi Y, Saleh GM, et al. Operating room performance improves after proficiency-based virtual reality cataract surgery training. Ophthalmology. 2017;124:524–31.View ArticlePubMedGoogle Scholar
- Borgersen NJ, Naur TMH, Sørensen SMD, Bjerrum F, Konge L, Subhi Y, et al. Gathering validity evidence for surgical simulation: a systematic review. Ann Surg 2018 4. https://doi.org/10.1097/SLA.0000000000002652.
- Ghaderi I, Manji F, Park YS, Juul D, Ott M, Harris I, et al. Technical skills assessment toolbox: a review using the unitary framework of validity. Ann Surg. 2015;261:251–62.View ArticlePubMedGoogle Scholar
- Cook DA, Brydges R, Zendejas B, Hamstra SJ, Hatala R. Technology-enhanced simulation to assess health professionals: a systematic review of validity evidence, research methods, and reporting quality. Acad Med. 2013;88(6):872–83.View ArticlePubMedGoogle Scholar
- Cook DA, Zendejas B, Hamstra SJ, Hatala R, Brydges R. What counts as validity evidence? Examples and prevalence in a systematic review of simulation-based assessment. Adv Health Sci Educ Theory Pract. 2014;19(2):233–50.View ArticlePubMedGoogle Scholar
- de Montbrun S, Satterthwaite L, Grantcharov TP. Setting pass scores for assessment of technical performance by surgical trainees. Br J Surg. 2015;103:300–6.View ArticlePubMedGoogle Scholar
- Yudkowsky R, Downing SM, Tekiam A. Standard Setting. In: Downing SM, Yudkowsky R, editors. Assessment in Health Professions Education. New York (NY): Routledge; 2009. p. 119–48.Google Scholar
- Thomsen AS, Subhi Y, Kiilgaard JF, la Cour M, Konge L. Update on simulation-based surgical training and assessment in ophthalmology: a systematic review. Ophthalmology. 2015;122:1111–30.View ArticlePubMedGoogle Scholar
- Goldenberg MG, Garbens A, Szasz P, Hauer T, Grantcharov TP. Systematic review to establish absolute standards for technical performance in surgery. Br J Surg. 2017;104:13–21.View ArticlePubMedGoogle Scholar
- Thinggaard E, Bjerrum F, Strandbygaard J, Gögenur I, Konge L. Validity of a cross-specialty test in basic laparoscopic techniques (TABLT). Br J Surg. 2015;102:1106–13.View ArticlePubMedPubMed CentralGoogle Scholar
- Jacobsen ME, Andersen MJ, Hansen CO, Konge L. Testing basic competency in knee arthroscopy using a virtual reality simulator: exploring validity and reliability. J Bone Joint Surg. 2015;97:775–81.View ArticlePubMedGoogle Scholar
- Tolsgaard MG, Ringsted C, Dreisler E, Klemmensen A, Loft A, Sorensen JL, et al. Reliable and valid assessment of ultrasound operator competence in obstetrics and gynecology. Ultrasound Obstet Gynecol. 2014;43:437–43.View ArticlePubMedGoogle Scholar
- Konge L, Clementsen P, Larsen KR, Arendrup H, Buchwald C, Ringsted C. Establishing pass/fail criteria for bronchoscopy performance. Respiration. 2012;83:140–6.View ArticlePubMedGoogle Scholar
- Beard JD. Education and Training Committee of the Vascular Society of Great Britain and Ireland. Setting standards for the assessment of operative competence. Eur J Vasc Endovasc Surg. 2005;30:215–8.View ArticlePubMedGoogle Scholar
- Diwadkar GB, van den Bogert A, Barber MD, Jelovsek JE. Assessing vaginal surgical skills using video motion analysis. Obstet Gynecol. 2009;114:244–51.View ArticlePubMedGoogle Scholar
- King CR, Donnellan N, Guido R, Ecker A, Althouse AD, Mansuria S. Development and validation of a laparoscopic simulation model for suturing the vaginal cuff. Obstet Gynecol. 2015;126:27–35.View ArticleGoogle Scholar
- Nerup N, Preisler L, Svendsen MB, Svendsen LB, Konge L. Assessment of colonoscopy by use of magnetic endoscopic imaging: design and validation of an automated tool. Gastrointest Endosc. 2015;81:548–54.View ArticlePubMedGoogle Scholar
- Thomsen ASS, Kiilgaard JF, Kjaerbo H, la Cour M, Konge L. Simulation-based certification for cataract surgery. Acta Ophthalmol. 2015;93:416–21.View ArticlePubMedGoogle Scholar
- Preisler L, Svendsen MB, Nerup N, Svendsen LB, Konge L. Simulation-based training for colonoscopy. Medicine. 2015;94:440–8.View ArticleGoogle Scholar
- Pedersen P, Palm H, Ringsted C, Konge L. Virtual-reality simulation to assess performance in hip fracture surgery. Acta Orthop. 2014;85:403–7.View ArticlePubMedPubMed CentralGoogle Scholar
- Konge L, Annema J, Clementsen P, Minddal V, Vilmann P, Ringsted C. Using virtual-reality simulation to assess performance in endobronchial ultrasound. Respiration. 2013;86:59–65.View ArticlePubMedGoogle Scholar
- Vassiliou MC, Dunkin BJ, Fried GM, Mellinger JD, Trus T, Kaneva P, et al. Fundamentals of endoscopic surgery: creation and validation of the hands-on test. Surg Endosc. 2013;28:704–11.View ArticlePubMedGoogle Scholar
- Svendsen MB. Using motion capture to assess colonoscopy experience level. World J Gastrointest Endosc. 2014;6:193–8.View ArticlePubMedPubMed CentralGoogle Scholar
- Sedlack RE. Training to competency in colonoscopy: assessing and defining competency standards. Gastrointest Endosc. 2011;74:355–66.View ArticlePubMedGoogle Scholar
- Sedlack RE, Coyle WJ. Assessment of competency in endoscopy: establishing and validating generalizable competency benchmarks for colonoscopy. Gastrointest Endosc. 2016;83:516–23.View ArticlePubMedGoogle Scholar
- McCluney AL, Vassiliou MC, Kaneva PA, Cao J, Stanbridge DD, Feldman LS, Fried GM. FLS simulator performance predicts intraoperative laparoscopic skill. Surg Endosc. 2007;21(11):1991–5.View ArticlePubMedGoogle Scholar
- Fraser SA, Klassen DR, Feldman LS, Ghitulescu GA, Stanbridge D, Fried GM. Evaluating laparoscopic skills: setting the pass/fail score for the MISTELS system. Surg Endosc. 2003;17(6):964–7.View ArticlePubMedGoogle Scholar