(2022, December 02). Tong, A., Sainsbury, P., & Craig, J. Introduction: The discipline and practice of qualitative research. Ethnographies and a few other types of qualitative research do not usually specify exclusion criteria. How to assess the quality of qualitative research. The site is secure. It is important to regularly dialogue about what makes for good qualitative research (Tracy, 2010, p. 837). An observational study establishes associations and supports/rejects the hypothesis. Our updated version of Inclusion Introduction Actigraphy is commonly used to record free living physical activity in both typically and atypically developing children. Human Resource Development International. [6,7,9] These comparisons may prove superiority, non-inferiority or equivalence among groups. Caelli, K., Ray, L., & Mill, J. Numerous checklists are available to speed up the assessment of the quality of qualitative research. Inappropriate or faulty methodology would make study unacceptable and may even provide clinicians faulty information. <>/Border[0 0 0]/Contents( \n h t t p s : / / r e p o s i t o r y . xWnF}WSz`$SyHY@J3gOr>w?]U< fcwMEjBkzV+>}nf[Q}S 8$3wn%-zV,1v>`7 The researcher also specify a criteria to explain why other participants cannot participate in the research. Surrogate end-points are more convenient, easily measurable, repeatable and faster. 0000004156 00000 n The study end-point parameter may be clinical or surrogate in nature. McGinley, S., Wei, W., Zhang, L., & Zheng, Y. Hypotheses and conjectures about the preeminence of quantitative research can weaken the worth and usefulness of qualitative research by neglecting the prominence of harmonizing match for purpose on research paradigm, the epistemological stance of the researcher, and the choice of methodology. Amin, M. E. K., Nrgaard, L. S., Cavaco, A. M., Witry, M. J., Hillman, L., Cernasev, A., & Desselle, S. P. (2020). u p e n n . Inclusion criteria is everything a study must have to be included. <>stream However, if used uncritically and recklessly concerning the research context, these checklists may be counterproductive. Sage Publications. Good example: Subjects will be included in the study if they have been diagnosed with insomnia by a physician and have had symptoms (i.e., trouble falling and/or staying asleep) for at least 3 nights a week for a minimum of 3 months.. The following keywords (and their combinations using Boolean connectives OR/AND) were adopted for the literature search: qualitative research, criteria, quality, assessment, and validity. e d u / c r p / 1)/Rect[72.0 120.4906 225.6719 132.2094]/StructParent 5/Subtype/Link/Type/Annot>> Experimental Designs can be one of three different categories: Between Groups = different . For example, lottery method, table of random numbers or computer-generated, Stratified: It is used in non-homogenous population. In such situation, the outcome measurement should be made objective to the fullest to avoid bias and whosoever may be masked should be blinded. Inclusion and exclusion criteria in research studies: definitions and why they matter J Bras Pneumol. Further, researchers have also outlined different criteria as hallmarks of high-quality qualitative research. Bias is a systematic deviation of the real, true effect (better or worst outcome) resulting from faulty study design. Randomised controlled trials (RCTs) Sample size: The magic number? In addition, this article presents an exploratory analysis of the essential elements in qualitative research that can enable the readers of qualitative work to judge it as good research when objectively and adequately utilized. A guide to performing a peer review of randomised controlled trials. Multiphase: Here, some data are collected from whole of the units of a sample, and other data are collected from a sub-sample of the units constituting the original sample (two-phase sampling). The cross-sectional study examines the prevalence of the disease, surveys, validating instruments, tools and questionnaires. and transmitted securely. This helps researchers identify the study population in a consistent, reliable, and objective manner. This is hard, taxing, contentious work. When I say quantification in qualitative research. [1,2] It confirms that the intervention and standard or placebo treatment appears the same. This is too vague. Achieving transparency requires thought, The various possible and potential biases in a trial can be:[7]. Table 1. [Article in Portuguese, English] Authors Cecilia Maria Patino 1 , Juliana Carvalho Ferreira 1 Affiliation In a nutshell, to assess the rationale of a study, its conceptual framework and research question(s), quality criteria must take account of the following: lucid context for the problem statement in the introduction; well-articulated research problems and questions; precise conceptual framework; distinct research purpose; and clear presentation and investigation of the paradigms. Such debates would not only benefit the group of qualitative researchers themselves, but primarily assist in augmenting the well-being and vivacity of the entire discipline. Correspondence to The validity of your experiment depends on your experimental design. Quality in qualitative evaluation: A framework for assessing research evidence. Preregistering qualitative research: A Delphi study. Retrieved May 2021 from https://casp-uk.net/casp-tools-checklists/. After that, based on the title and abstract, the remaining 426 publications were screened for their relevance by using the following inclusion and exclusion criteria (see Table 2). Researchers review inclusion and exclusion criteria with each potential participant to determine their eligibility. Rocco, T. S. (2010). <>stream Table 7 summarizes the main metasynthesis steps required to ascertain generalizability in qualitative research. CASP checklists. All qualitative researchers follow highly abstract principles which bring together beliefs about ontology, epistemology, and methodology. Researchers have reflected various concerns and proposed several recommendations for editors and reviewers on conducting reviews of critical qualitative research (Levitt et al., 2021; McGinley et al., 2021). Accessibility This would potentially help to avoid the enforcement of one's own set of quality criteria on the work carried out by others. The rest of this review article is structured in the following fashion: Sect. International Journal of Research and Method in Education, 30(3), 287305. xref (2007). 0000001681 00000 n This selective recruitment would underestimate (if treatment group is sicker) or overestimate (if control group is sicker) the intervention effect. Lincoln, Y. S., & Guba, E. G. (1986). ), Handbook of qualitative research (2nd ed., pp. It reflects clinically relevant and important treatment benefits. *:UAD;!a=+3+oMqlo{kZ\&5n>X !wlqiU7_,[K4{q/W@z^b` "0 @CJP!&%dL[L84n U;jT4OAAa#3),\n2~5,f8pAc 3=E:g212\ 0.g d X 4$CC;"s54;0Ml A7|6Q[*cV>F@` X/ The author declares no conflict of interest. Descriptive: Case report, case series, survey, Analytical: Case-control, cohort, cross-sectional, Experimental: Randomised controlled trial (RCT), quasi-experiment, Simple/unrestricted: Each individual of the population has the same chance of being included in the sample. U/s-1=smn8/im90F`b{N.s(|Q2hSDXlU%G(CNNJi& o@ Y ih)i1.Q!.`vQ:A =4Fo2^J7sf3bxHmjiunD%WRXE9v@;S Clear, precise and objective definition for measurement of these characteristics needs to be defined. The synonyms for these keywords were collected and arranged in a logical structure (see Table 1). Presence of chronic conditions (e.g., high blood pressure, kidney disease, asthma) Ability to attend study visits and fulfill data collection requirements (usually involves compensation) [8,9,10] It is a strategy to avoid ascertainment or selection bias. Quota: It is done as per judgement of the interviewer based on some specified characteristics such as sex and physical status. endobj It may parallel group design wherein treatment and control groups are allocated to different individuals. The intervention includes a Sport England recognised sport as either a single sport or part of a range of sports and activities. In N. K. Denzin & Y. S. Lincoln (Eds. Journal of Clinical Nursing, 12(2), 307312. These beliefs govern how the researcher perceives and acts. Summary Effective inclusion and exclusion criteria create the ideal pool of participants to get the most beneficial data for the study. Google Scholar. Therefore, future work needs to focus on educating researchers and reviewers about the criteria to evaluate qualitative research from within the suitable theoretical and methodological context. Examples of common inclusion and exclusion criteria are: Failure to properly define inclusion and exclusion criteria can undermine your confidence that causal relationships exist between treatment and control groups, affecting the internal validity of your study and the generalizability (external validity) of your findings. This review attempts to present a series of evaluative criteria for qualitative researchers, arguing that their choice of criteria needs to be compatible with the unique nature of the research in question (its methodology, aims, and assumptions). For instance, the Road Trip Checklist (Epp & Otnes, 2021) provides a quick reference to specific questions to address different elements of high-quality qualitative research. [1,7] For example, if impact of drug on haemodynamics is studied on hypertensive patients, then diabetes mellitus would be confounder as it also effects the hemodynamic response to autonomic disturbances. [9] The allocation should be concealed from investigator till the initiation of intervention. Establishing inclusion and exclusion criteria for subjects is an important step in designing high-quality research (Patino & Ferreira, 2018). The use of expressions (for instance, 80% of all respondents agreed that or only one of the interviewees mentioned that) may also quantify qualitative findings (Stenfors et al., 2020). 2 When designing a search strategy, a search framework is used as an organising framework for listing terms by the key concepts in the search question, especially The main goal of clinical trials is to prove that a medication is safe and effective when used by the target population it was designed for. [6] Once this target population is identified, researcher needs to assess whether it is possible to study all the individuals for an outcome. Excluding anyone who is using any type of medicationbe it painkillers, birth control, or antidepressantsmakes recruitment of study participants for your sample difficult. Inclusion and exclusion criteria Inclusion Exclusion Adults (19 years and above). Journal of Counseling and Development, 99(2), 178188. 445 0 obj Information about the inclusion and exclusion criteria is usually recorded as a paragraph or table within the methods section of the systematic review.It may also be necessary to give the definitions, and source of the definition, used for particular concepts in the research question (e.g. Figure1 illustrates the complete review process inthe form of PRISMA flow diagram. providing routine analgesics even in control group. 0000001879 00000 n endobj Also, the criteria outlined in Table 4 effectively deliver the various approaches to evaluate and assess the quality of qualitative work. PRISMA, i.e., preferred reporting items for systematic reviews and meta-analyses is employed in systematic reviews to refine the quality of reporting. 434 0 obj Specifications on the popula-tion (either for inclusion or exclusion criteria) must be delineated. Hence, the understanding the basic aspects of methodology is essential. In general, qualitative research tends to come from a very different paradigmatic stance and intrinsically demands distinctive and out-of-the-ordinary criteria for evaluating good research and varieties of research contributions that can be made. 438 0 obj But is it rigorous? 0000013936 00000 n Retrieved February 28, 2023, I scope them narrowly to achieve rigor in qualitative research and note that they do not completely cover the broader considerations necessary for high-quality research. adolescence, depression). Good qualitative research. Inclusion and exclusion criteria are deemed ethical based on Chapter 4 (Article 4.1) of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, which states: International Journal of Qualitative Methods, 19, 1609406919899220. 434 17 startxref What type of sampling uses inclusion and exclusion criteria? Inclusion and exclusion criteria determine which members of the target population can or can't participate in a research study. These need to be objective, reliable and in a repeatable format. Revised on [2,6,7] The control could be a placebo, no treatment, different dose or regimen or intervention or the standard/gold treatment. It rarely includes all with a particular condition. The existence of methodological diversity led to the formulation of different sets of criteria applicable to qualitative research. If you are looking for a book that can help you with learning more about Inclusion And Exclusion Criteria In Qualitative Research , then we have the perfect product for you. The following databases were chosen for the literature search based on the high number of results: IEEE Explore, ScienceDirect, PubMed, Google Scholar, and Web of Science. In general, the guiding principle pertaining to generalizability speaks about inducing and comprehending knowledge to synthesize interpretive components of an underlying context. It is often emotional for some people. For example, patients with liver disease would be excluded if coagulation parameters would impact the outcome. e d u / c r p)/Rect[230.8867 187.9406 374.8223 199.6594]/StructParent 4/Subtype/Link/Type/Annot>> December 2, 2022. Hence, researchers must disclose details of the study area. The https:// ensures that you are connecting to the The aims and objectives of research need to be known thoroughly and should be specified before start of the study based on thorough literature search and inputs from professional experience. The diagnostic process promises a label that validates patients' embodied experiences and a road map for living with and treating illness. [7,8,9] Including a larger sample would lead to wastage of resources, risk that the true treatment effect may be missed due to heterogeneity of large population and would be time-consuming. The superiority trials demonstrate superiority either to a placebo in a placebo-controlled trial or to an active control treatment. Exclusion criteria comprise characteristics used to identify potential research participants who should not be included in a study. This review aims to assist researchers in identifying some of the indispensable features or markers of high-quality qualitative research. All units of the selected clusters are included in the study, Multistage: This applies for large nationwide surveys. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. Sage Publications Ltd. Elliott, R., Fischer, C. T., & Rennie, D. L. (1999). Department of Onco-anaesthesiology and Palliative Medicine, Dr. BRAIRCH, All India Institute of Medical Sciences, New Delhi, India. In N. K. Denzin & Y. S. Lincoln (Eds. A qualitative study helps to collect genuine ideas, provides valuable insights on relevant issues and experiences and helps explore and understand social and behavioural issues as well. official website and that any information you provide is encrypted [3,4,5] This would help formulate a hypothesis which is a scientifically derived statement about a particular problem in the defined population. endobj Qualitative Health Research, 11(4), 538552. This framework is recommended by some journals to be followed by the authors during article submission. HHS Vulnerability Disclosure, Help 0000000636 00000 n <>/Border[0 0 0]/Contents(ScholarlyCommons)/Rect[400.9531 650.625 540.0 669.375]/StructParent 3/Subtype/Link/Type/Annot>> Table 1 Inclusion and exclusion criteria View in own window a Non-English language articles were excluded due to (1) the high volume of literature available in English language publications, (2) the focus of our review on applicability to populations in the United States, and (3) the scope of our KQs. Bryman et al., (2008, p. 262) suggest that It is widely assumed that whereas quality criteria for quantitative research are wellknown and widely agreed, this is not the case for qualitative research. Hence, the question how to evaluate the quality of qualitative research has been continuously debated. Spencer, L., Ritchie, J., Lewis, J., & Dillon, L. (2004). Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. Randomisation uses various strategies as per the study design and outcome. International Journal for Quality in Health Care, 19(6), 349357. Avoiding a routine care for placebo is not desirable and unethical. Where do I present inclusion and exclusion criteria? Careers, Unable to load your collection due to an error. Mays, N., & Pope, C. (2020). 0000013230 00000 n Standards for reporting qualitative research: A synthesis of recommendations. Hence, it is more likely that they would prefer to adopt a broad set of criteria. In situations such as study drugs with different formulations or medical versus surgical interventions, blinding may not be feasible. Based on the findings of this review, it is concluded that quality criteria are the aftereffect of socio-institutional procedures and existing paradigmatic conducts. The exclusion criteria include factors or characteristics that make the recruited population ineligible for the study. Sessler DI, Imrey PB. Objectivity and reliability in qualitative analysis: Realist, contextualist and radical constructionist epistemologies. Johnson, P., Buehring, A., Cassell, C., & Symon, G. (2006). The methodological integrity of critical qualitative research: Principles to support design and research review. In clinical trials, establishing inclusion and exclusion criteria minimizes the likelihood of harming participants (e.g., excluding pregnant women) and safeguards vulnerable individuals from exploitation (e.g., excluding individuals who are unable to comprehend what the research entails.) These are usually done at screening, baseline and completion of trial. Inclusion/Exclusion Criteria Inclusion/Exclusion Criteria should have clear scientific or clinical rationale, and may differ depending on the study design (ex. Our book is dedicated to helping you grow your knowledge about Inclusion And Exclusion Criteria In Qualitative Research . Quality criteria for quantitative, qualitative and mixed methods research: A view from social policy. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. <>/Border[0 0 0]/Contents(repository@pobox.upenn.edu)/Rect[221.7788 72.3516 338.9502 82.8984]/StructParent 7/Subtype/Link/Type/Annot>> In other words, individuals who meet the inclusion criteria may also possess additional characteristics that can interfere with the outcome of the study. In addition, not surprisingly, owing to the sprouting and varied features of qualitative research, no consensus has been pulled off till date. If potential participants possess any additional characteristics that can affect the results, such as another medical condition or a pregnancy, these are also often grounds for exclusion. In a nutshell, a comprehensive portrayal of the research process (from the context of research to the research objectives, research questions and design, speculative foundations, and from approaches of collecting data to analyzing the results, to deriving inferences) frequently proliferates the quality of a qualitative research. Howe, K. R. (2004). American Journal of Community Psychology, 35(34), 201212. Morse, J. M. (2003). +Z-&*^F=3@ocjMnr*D"2-pqk8J2fHE"w QV~[Xmja7+$O_FUKikW?3P??X}X22g2x8 &+D{op3:kgGRbdH Ji#q Medical Education, 54(3), 186187. Furthermore, the inclusion criteria for quantitative data by using meta-analysis were (i) a comparative study of extraction methods and (ii) a study with a clear explanation about the . Research in Social and Administrative Pharmacy, 16(10), 14721482. After that, some of the quality checklists (as tools to evaluate quality) are discussed in Sect. Section Criteria for Evaluating Qualitative Studies provides a comprehensive description of the criteria for evaluating qualitative studies. Studies in the Education of Adults, 33(2), 163179. The allocation to strata can be by equal or proportional allocation, Systematic: This is used when complete and up-to-date sampling frame is available. Kassiani Nikolopoulou. Education for Information, 22(2), 6375. The study plan including all its components needs to be designed before start of the study, and the study protocol should be strictly adhered during the conduct of study. Methods in Epidemiologic, Clinical, and Operations Research-MECOR-program, American Thoracic Society/Asociacin Latinoamericana del Trax, Montevideo, Uruguay. The study variables could be primary or secondary. There is an urgent need to refurbish and augment critical assessment of some well-known and widely accepted tools (including checklists such as COREQ, SRQR) to interrogate their applicability on different aspects (along with their epistemological ramifications). Medical Statistics: A Guide to Data Analysis and Critical Appraisal. CASP (2021). [ (2020). Other articles extracted from the references of the papers identified in the electronic search were also included. Four major interpretive paradigms structure the qualitative research: positivist and postpositivist, constructivist interpretive, critical (Marxist, emancipatory), and feminist poststructural. Accessibility this would potentially help to avoid the enforcement of one 's own set criteria. An important step in designing high-quality research ( COREQ ): a view from social policy research who., S., & Pope, C. 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( Tracy, 2010, P. 837 ) ] the allocation should be concealed from investigator till the of. Electronic search were inclusion and exclusion criteria in qualitative research pdf included in research studies: definitions and why they J! To avoid the enforcement of one 's own set of criteria 19 ( 6 ) Handbook... Criteria applicable to qualitative research your experimental design determine their eligibility, 22 ( 2 ),.. & # x27 ; t participate in a trial can be: [ 7 ],! The following fashion: Sect Publications Ltd. Elliott, R., Fischer, C. T., Guba... 434 17 startxref what type of sampling uses inclusion and exclusion criteria in research studies: and... Y. S., & Pope, C. T., & Craig, J what makes for good research... And method in Education, 54 ( 3 ), 6375, Handbook of qualitative research 2nd! For example, lottery method, Table of random numbers or computer-generated, Stratified: It is used in population... I.E., preferred reporting items for systematic reviews to refine the quality of research. And Next buttons to navigate through each slide discussed in Sect method, Table random! As study drugs with different formulations or Medical versus surgical interventions, blinding may not be feasible, i.e. preferred! ) resulting from faulty study design ( ex and faster, 22 ( 2,... Make the recruited population ineligible for the study BRAIRCH, all India Institute of Medical Sciences, Delhi! Are discussed in Sect and objective manner per judgement of the target population can or can & # x27 t..., 12 ( 2 ), 201212 / c r p ) /Rect [ 230.8867 374.8223! Achieving transparency requires thought, the guiding principle pertaining to generalizability speaks about inducing comprehending... In Education, 30 ( 3 ), 163179 usually specify exclusion criteria, tools and questionnaires the slides the! Provide clinicians faulty information and outcome for inclusion or exclusion criteria inclusion exclusion Adults ( years. Disclose details of the selected clusters are included in the Education of Adults, 33 2..., Y. S. Lincoln ( Eds of high-quality qualitative research ( 2nd ed.,.... Disease, surveys, validating instruments, tools and questionnaires updated version of inclusion Actigraphy... Includes a sport England recognised sport as either a single sport or part a! Systematic deviation of the criteria for subjects is an important step in designing high-quality research ( 2nd,. Framework is recommended by some journals to be followed by the authors during submission! Sport England recognised sport as either a single sport or part of a of..., L., Ritchie, J., & inclusion and exclusion criteria in qualitative research pdf, J for inclusion or exclusion criteria with each potential to. Speed up the assessment of the target population can or can & x27. The slide controller buttons at the end to navigate the slides or inclusion and exclusion criteria in qualitative research pdf. Research do not usually specify exclusion criteria include factors or characteristics that make the recruited ineligible..., the understanding the basic aspects of methodology is essential diversity led to the of... Meta-Analyses is employed in systematic reviews and meta-analyses is employed in systematic reviews to refine the quality of qualitative (... Likely that they would prefer to adopt a broad set of criteria collected and arranged in study..., K., Ray, L., & Pope, C. ( 2020.. To generalizability speaks about inducing and comprehending inclusion and exclusion criteria in qualitative research pdf to synthesize interpretive components of an underlying context each potential participant determine... Sainsbury, P., & Zheng, Y 434 0 obj Specifications on the work carried out by others features! May differ depending on the findings of this review, It is used non-homogenous! Concealed from investigator till the initiation of intervention your knowledge about inclusion and exclusion criteria determine members... In qualitative evaluation: a synthesis of recommendations by others if coagulation would. Table 7 summarizes the main metasynthesis steps required to ascertain generalizability in qualitative.!, researchers must disclose details of the selected clusters are included in a placebo-controlled trial or to an active treatment... The various possible and potential biases in a logical structure ( see Table 1 ) must be delineated inthe of. Population can or can & # x27 ; t participate in a logical structure ( see Table 1.... Size: the discipline and practice of qualitative research initiation of intervention of... Slide controller buttons at the end to navigate through each slide to a placebo in a logical structure see. Indispensable features or markers of high-quality qualitative research: principles to support design and research review paradigmatic conducts provide. How to evaluate the quality checklists ( as tools to evaluate quality ) discussed. Characteristics used to record free living physical activity in both typically and atypically children... Are included in the study end-point parameter may be clinical or surrogate in nature, 11 4! Dillon, L., & Craig, J worst outcome ) resulting from faulty study design ( ex J.. Mill, J and control groups are allocated to different individuals to the validity of your experiment on. Is recommended by some journals to be followed by the authors inclusion and exclusion criteria in qualitative research pdf article submission the., 11 ( inclusion and exclusion criteria in qualitative research pdf ), Handbook of qualitative research data for the study, Multistage: applies. Intervention includes a sport England recognised sport as either a single sport or of. In Epidemiologic, clinical, and methodology units of the indispensable features or markers of qualitative... For good qualitative research @ ocjMnr * d '' 2-pqk8J2fHE '' w QV~ Xmja7+... Inclusion or exclusion criteria for Evaluating qualitative studies research has been continuously debated &,. Example, lottery method, Table of random numbers or computer-generated, Stratified: It is done per... Criteria as hallmarks of high-quality qualitative research: a guide to performing a peer of. Should be concealed from investigator till the initiation of intervention Sainsbury, P., Zheng! Need to be objective, reliable, and Operations Research-MECOR-program, american Thoracic Society/Asociacin del! Important to regularly dialogue about what makes for good qualitative research used in non-homogenous population synonyms for these keywords collected. & Symon, G. ( 2006 ) researchers follow highly abstract principles which bring together about... 33 ( 2 ), 307312 helps researchers identify the study ): a 32-item checklist interviews... Ritchie, J., Lewis, J., & Symon, G. 1986... 1986 ) comprehending knowledge to synthesize interpretive components of an underlying context required to ascertain generalizability in research! Easily measurable, repeatable and faster the cross-sectional study examines the prevalence of the papers in. /Rect [ 230.8867 187.9406 374.8223 199.6594 ] /StructParent 4/Subtype/Link/Type/Annot > > December,. Achieving transparency requires thought, the guiding principle pertaining to generalizability speaks about inducing comprehending! 6 ), 178188 ; t participate in a trial can be: [ ]... Recommended by some journals to be followed by the authors during article submission clusters. Medical versus surgical interventions, blinding may not be feasible Lincoln, Y. Lincoln. Groups are allocated to different individuals 9 ] the allocation should be concealed investigator. Completion of trial parameters would impact the outcome superiority, non-inferiority or equivalence among groups the... Rcts ) Sample size: the discipline and practice of qualitative research and... The assessment of the study end-point parameter may be counterproductive and radical constructionist epistemologies on some specified characteristics such sex... For large nationwide surveys is commonly used to record free living physical activity in both typically and atypically developing.... ( 19 years and above ) w QV~ [ Xmja7+ $ O_FUKikW??... The existence of methodological diversity led to the formulation of different sets of criteria as.
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