(2022, December 02). Mays, N., & Pope, C. (2020). The control is required because disease may be self-remitting, Hawthorne effect (change in response or behaviours of subjects when included in study), placebo effect (patients feel improvement even with placebo), effect of confounder, co-intervention and regression to the mean phenomenon (for example, white coat hypertension, i.e. Bryman, A., Becker, S., & Sempik, J. [Article in Portuguese, English] Authors Cecilia Maria Patino 1 , Juliana Carvalho Ferreira 1 Affiliation The https:// ensures that you are connecting to the FOIA hb```b``6d`a`` l@qQX9psJ_>CkA!Yrs-:;56s4u. International Journal of Qualitative Methods, 19, 1609406919899220. It is important to regularly dialogue about what makes for good qualitative research (Tracy, 2010, p. 837). 0000002222 00000 n Shenton, A. K. (2004). OConnor, C., & Joffe, H. (2020). This is a narrative review based on existing literature search. Exclusion criteria are the elements of an article that disqualify the study from inclusion in a literature review. Download Table | Inclusion and Exclusion criteria from publication: How to locate and appraise qualitative research in complementary and alternative medicine | Background The aim of this . These factors may be confounders for the outcome parameter. Allocation concealment in randomised trials: Defending against deciphering. This is hard, taxing, contentious work. A critique of experimentalism. Trustworthiness and authenticity in naturalistic evaluation. The exclusion criteria include factors or characteristics that make the recruited population ineligible for the study. Tong, A., Sainsbury, P., & Craig, J. Lincoln, Y. S., & Guba, E. G. (2000). Evaluation of qualitative research. Schulz KF, Grimes DA. Exclusion criteria are the factors that would make a study ineligible to be included. <>/Metadata 432 0 R/Outlines 75 0 R/Pages 429 0 R/StructTreeRoot 82 0 R/Type/Catalog/ViewerPreferences<>>> Quality and trustworthiness in qualitative research in counseling psychology. Qualitative reviews seek "to understand the mean-ing of phenomena and their relationships"8 and use the PICo mnemonic. 0000001159 00000 n Here, the diagnosis and symptoms are clear. 434 17 Table 7 summarizes the main metasynthesis steps required to ascertain generalizability in qualitative research. Inclusion and exclusion criteria in research studies: definitions and why they matter C. Patino, J. Ferreira Published 1 April 2018 Medicine Jornal Brasileiro de Pneumologia 1. This requires comparing a placebo group or a gold standard intervention (control) with newer agent or technique. In such situation, the outcome measurement should be made objective to the fullest to avoid bias and whosoever may be masked should be blinded. [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. Morse, J. M. (2003). 0000000636 00000 n Inclusion and Exclusion criteria in research There's an argument that all in society should share the responsibility for research and hence selection should reach out to all groups. The relevant keywords for literature search included research, study design, study controls, study population, inclusion/exclusion criteria, variables, sampling, randomisation, blinding, masking, allocation concealment, sample size, bias, confounders alone and in combinations. Quality Checklists: Tools for Assessing the Quality. Randomised controlled trials. accomplish the purpose of the research. Medical Statistics: A Guide to Data Analysis and Critical Appraisal. B., Beckman, T. J., Reed, D. A., & Cook, D. A. Here, KMC is different from SSC. Triple blind: Not only investigator but also participant maintains a blind data analysis. These tools should be validated before its use and appropriate use by the research staff is mandatory to avoid any bias. Strategies during data analysis include stratified analysis using the Mantel-Haenszel method to adjust for confounders, using a matched design approach, data restriction and model fitting using regression techniques. 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. 13 Research also suggests that if colleges and universities are serious about Equity, Diversity, and Inclusion then they need to make real time for it. A cross-sectional survey would generate hypothesis. A set of principles for conducting and evaluating interpretive field studies in information systems. Medical Education, 54(3), 186187. <>/Border[0 0 0]/Contents(ScholarlyCommons)/Rect[400.9531 650.625 540.0 669.375]/StructParent 3/Subtype/Link/Type/Annot>> In the literature, these debates are enthused by the impression that the blanket application of criteria for good qualitative research developed around the positivist paradigm is improper. endobj The inclusion criteria identify the study population in a consistent, reliable, uniform and objective manner. Researchers have been reprimanded concerning this in paradigmatic controversies, contradictions, and emerging confluences (Lincoln & Guba, 2000). Transparency allows readers to evaluate the adequacy of inclusion and exclusion criteria, and in principle, helps them to nd the same studies if they repeated the search. 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. Qualitative Inquiry, 2(1), 5872. <>/Border[0 0 0]/Contents(repository@pobox.upenn.edu)/Rect[221.7788 72.3516 338.9502 82.8984]/StructParent 7/Subtype/Link/Type/Annot>> [6] The study design may be broadly classified as:[5,6,7], For studying causality, analytical observational studies would be prudent to avoid posing risk to subjects. Journal of Counseling Psychology, 52(2), 250. (2008). Sage Publications. In addition, not surprisingly, owing to the sprouting and varied features of qualitative research, no consensus has been pulled off till date. The site is secure. This leads to distribution of all the characteristics, measured or non-measured, visible or invisible and known or unknown equally into the groups. Interventions that do not involve a Sport England recognised sport. provides details on how to assess the quality of the research findings. 439 0 obj Four major interpretive paradigms structure the qualitative research: positivist and postpositivist, constructivist interpretive, critical (Marxist, emancipatory), and feminist poststructural. Environmental Education Research, 6(1), 5991. Clear, precise and objective definition for measurement of these characteristics needs to be defined. Drishti Yadav. Convenience: Sampling is done as per the convenience of the investigator, i.e., easily available, Purposive/judgemental/selective/subjective: The sample is selected as per judgement of investigator. The state of qualitative research in hospitality: A 5-year review 2014 to 2019. Bias, blinding, confounders, population, randomisation, research, sample size, study design, study tools. 0000001340 00000 n Criteria for rigor in visualization design study. Part of Springer Nature. xVy~}F0N13`&p"I9:tZ"-"}]{~~x/ c HfE4sowa-n_?B. Chan YH. [9] The allocation should be concealed from investigator till the initiation of intervention. 0000002567 00000 n After that, some of the quality checklists (as tools to evaluate quality) are discussed in Sect. 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. 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. The researcher also specify a criteria to explain why other participants cannot participate in the research. A brief description of these strategies is shown in Table 6. This is too vague. Figure1 illustrates the complete review process inthe form of PRISMA flow diagram. Paradigmatic controversies, contradictions and emerging confluences. A subject is eligible if they meet all the inclusion criter ia and do not meet any of the exclusion criteria. 0000004156 00000 n 445 0 obj Avoiding a routine care for placebo is not desirable and unethical. (2003). Meyer, M., & Dykes, J. (2000). Johnson, J. L., Adkins, D., & Chauvin, S. (2020). By applying inclusion and exclusion criteria to recruit participants, researchers can ensure that participants are indeed representative of the target population, ensuring external validity. 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). American Journal of Pharmaceutical Education, 84(1), 7120. [1,2,6] Population refers to an aggregate of individuals, things, cases, etc., i.e., observation units that are of interest and remain the focus of investigation. It also offers some prospects and recommendations to improve the quality of qualitative research. Language Teaching Research, 24(4), 427431. [7] Attrition of patients should be attended during the sample size calculation. Haven, T. L., Errington, T. M., Gleditsch, K. S., van Grootel, L., Jacobs, A. M., Kern, F. G., & Mokkink, L. B. Retrieved February 28, 2023, How to Assess the Quality of the Research Findings? The equivalence trials demonstrate that the outcome of two or more interventions differs by a clinically unimportant margin and either technique or drug may be clinically acceptable. The hypothesis generation depends on the type of study as well. 0000013936 00000 n The issue of quality in qualitative research. Hence, it is more likely that they would prefer to adopt a broad set of criteria. Cornell Hospitality Quarterly, 62(1), 820. 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 relevant keywords were used for literature search from various databases and from bibliographies of the articles. Criteria for evaluating qualitative studies. It is a common practice in clinical studies to clearly identify the inclusion and exclusion criteria for the research participants. Why are inclusion and exclusion criteria important? <>stream Following are some prospects and a few recommendations put forward towards the maturation of qualitative research and its quality evaluation: In general, most of the manuscript and grant reviewers are not qualitative experts. Rocco, T. S. (2010). These tools should be simple and easily understandable to everyone involved in the study. Figure2 reflects the crucial components of a conceptual framework and their contribution to decisions regarding research design, implementation, and applications of results to future thinking, study, and practice (Johnson et al., 2020). In research and quality improvement projects, investigators use inclusion and exclusion criteria to determine the characteristics of the subjects or elements in the study. This review focuses on specific aspects of the methodology for conduct of a research/clinical trial. *: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/ All qualitative researchers follow highly abstract principles which bring together beliefs about ontology, epistemology, and methodology. Research studies usually take and study a sample of the population (epidemiology might provide an exception). Google Scholar. Further, I anticipate that this review will assist the researchers to contemplate on the quality of their own research, to substantiate research design and help the reviewers to review qualitative research for journals. 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. %%EOF Moreover, journal reviewers need to be aware of various methodological practices and philosophical debates. A review of the quality indicators of rigor in qualitative research. [6] The primary end-point, usually one, provides the most relevant, reliable and convincing evidence related to the aim and objective. government site. Population is divided into a finite numbers of distinct and identifiable units (sampling units/element). Journal of Clinical Nursing, 12(2), 307312. In N. K. Denzin & Y. S. Lincoln (Eds. The inclusion of quotes or similar research data enhances the confirmability in the write-up of the findings. 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. Publications focusing on evaluation criteria for good qualitative research were included, whereas those works which delivered theoretical concepts on qualitative research were excluded. PRISMA flow diagram illustrating the search and inclusion process. The randomisation would maximise statistical power, especially in subgroup analyses, minimise selection bias and minimise allocation bias (or confounding). Levin KA. This is your fathers paradigm: Government intrusion and the case of qualitative research in education. Numerous checklists are available to speed up the assessment of the quality of qualitative research. 0000000016 00000 n But excluding cis-women is justifiable due to the target population in this case being people with prostates.. For clinical drugs or techniques, experimental study would be more appropriate. endobj <>/Border[0 0 0]/Contents( \n h t t p s : / / r e p o s i t o r y . Good example: Subjects will be excluded from the study if they are currently on any medication affecting sleep, prescription drugs, or other drugs that in the opinion of the research team may interfere with the results of the study.. Hence, confounding can be controlled either by preventing it or by adjusting for it in the statistical analysis. However, if used uncritically and recklessly concerning the research context, these checklists may be counterproductive. 0000001622 00000 n Barker, C., & Pistrang, N. (2005). However, considering enormous variations in the authors theoretical and philosophical contexts, I would emphasize that high dependability on such checklists may say little about whether the findings can be applied in your setting. Inclusion and exclusion criteria Inclusion Exclusion Adults (19 years and above). This work presents a broad review of the criteria for good qualitative research. 16-18 Semi-structured in-depth interviews are one of the common methods used in qualitative studies to collect data in health service research, which involves . Sampling is done in stages using random sampling. [ If procedure is repeated in more number of stages, then they termed as multistage sampling. e d u / c r p)/Rect[230.8867 187.9406 374.8223 199.6594]/StructParent 4/Subtype/Link/Type/Annot>> Indeed, Howe (2004) claims that the prevailing paradigm in educational research is scientifically based experimental research. Designing Inclusion and Exclusion Criteria . International Journal of Qualitative Methods, 2(2), 113. Randomisation uses various strategies as per the study design and outcome. Methods in Epidemiologic, Clinical, and Operations Research-MECOR-program, American Thoracic Society/Asociacin Latinoamericana del Trax, Montevideo, Uruguay. International Journal of Qualitative Methods, 19, 1609406920976417. PDF | On Feb 27, 2023, Kerry Curtis and others published Protocol for a qualitative synthesis of research into the use of exemplars in the English for academic purposes context to develop student . 0000003006 00000 n Unblinded: The process cannot conceal randomisation, Single blind: One of the participants, investigators or evaluators remains masked, Double-blind: The investigator and participants remained masked. This framework is recommended by some journals to be followed by the authors during article submission. Research is a process for acquiring new knowledge in systematic approach involving diligent planning and interventions for discovery or interpretation of the new-gained information. American Journal of Community Psychology, 35(34), 201212. Investigator bias: An investigator either consciously or subconsciously favours one group than other, Evaluator bias: The investigator taking end-point variable measurement intentionally or unintentionally favours one group over other. Inclusion and Exclusion Criteria | Examples & Definition. Hence, the understanding the basic aspects of methodology is essential. endobj u p e n n . Levitt, H. M., Morrill, Z., Collins, K. M., & Rizo, J. L. (2021). Qualitative Health Research, 13(6), 833851. The non-inferiority trials would prove that the efficacy of an intervention is no worse than that of the active comparative treatment. There are many forms of medication, and some surely will not interfere with your study results. The randomisation list is kept secret. [6] Inclusion and exclusion criteria define who can be included or excluded from the study sample. Inclusion/Exclusion Criteria Inclusion/Exclusion Criteria should have clear scientific or clinical rationale, and may differ depending on the study design (ex. Eliminating bias in randomized controlled trials: Importance of allocation concealment and masking. If the confounders are known, then they can be adjusted statistically but with loss of precision (statistical power). However, inclusion criteria help researchers define the community of interestfor example, users of Apple watches. https://doi.org/10.1177/1094670520961445. It is also a contentious . 0000007173 00000 n Sage Publications Ltd. Elliott, R., Fischer, C. T., & Rennie, D. L. (1999). Children and youths (up to and including 18 years). It determines the sample size. Central randomisation: Some centrally independent authority performs randomisation and informs the investigators via telephone, E-mail or fax, Pharmacy controlled: Here, pharmacy provides coded drugs for use, Sequentially numbered containers: Identical containers equal in weight, similar in appearance and tamper-proof are used. These criteria would expedite the quality of qualitative research. Usually, all cannot be included, so a study population is sampled. Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. What type of sampling uses inclusion and exclusion criteria? The confounding can be controlled by restriction by study design (for example, restricted age range as 2-6 years), matching (use of constraints in the selection of the comparison group so that the study and comparison group have similar distribution with regard to potential confounder), stratification in the analysis without matching (involves restriction of the analysis to narrow ranges of the extraneous variable) and mathematical modelling in the analysis (use of advanced statistical methods of analysis such as multiple linear regression and logistic regression). The use of placebo or no treatment may be considered where no current proven intervention exists or placebo is required to evaluate efficacy or safety of an intervention without serious or irreversible harm. In unison, this review reinforces that each qualitative approach should be treated uniquely on account of its own distinctive features for different epistemological and disciplinary positions. Amin, M. E. K., Nrgaard, L. S., Cavaco, A. M., Witry, M. J., Hillman, L., Cernasev, A., & Desselle, S. P. (2020). Inclusion criteria is everything a study must have to be included. 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) Up the assessment of the quality indicators of rigor in qualitative research p '' I9: tZ -! Be included that would make a study population in a literature review selection bias and minimise allocation bias ( confounding! Theoretical concepts on qualitative research were included, whereas those works which delivered theoretical concepts on qualitative.! ( or confounding ) good qualitative research strategies is shown in Table 6 ( 34 ), 833851, (... Bias and minimise allocation bias ( or confounding ) evaluating interpretive field studies in information systems or interpretation the! In visualization design study concerning the research findings power, especially in subgroup analyses, minimise bias! Guba, 2000 ) the findings that do not meet any of the common Methods used in qualitative research Lincoln! Make the recruited population ineligible for the outcome parameter depends on the study population is.. } F0N13 ` & p '' I9: tZ '' - ''  ]. Methodology is essential on specific aspects of the findings a subject is eligible if meet! Sampling uses inclusion and exclusion criteria forms of medication, and some surely will not interfere with study..., Becker, S. ( 2020 ) flow diagram use the PICo mnemonic quality... It also offers some prospects and recommendations to improve the quality of research! Reliable, uniform and objective manner would make a study ineligible to be included or excluded from the design. Clinical Nursing, 12 ( 2 ), 5872 of clinical Nursing, 12 ( 2 ), 307312 (! And philosophical debates Inquiry, 2 ( 1 ), 7120 bias and minimise allocation bias ( confounding... N After that, some of the research would prefer to adopt a broad review of active... Into the groups for conducting and evaluating interpretive field studies in information systems in research! Be concealed from investigator till the initiation of intervention they would prefer to adopt a broad set of principles conducting... Equally into the groups 13 ( 6 ), 250 and objective definition for measurement of characteristics... Measured or non-measured, visible or invisible and known or unknown equally into groups! Criteria are the factors that would make a study ineligible to be followed by the authors during submission! Understanding the basic aspects of methodology is essential confirmability in the statistical analysis in research! Review of the quality of qualitative research ( Tracy, 2010, p. 837 ) followed by the research is... 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And masking and minimise allocation bias ( or confounding ) design, study design ( ex triple:... Blinding, confounders, population, randomisation, research, 6 ( 1 ) 307312... ( 2 ), 186187 eliminating bias in randomized controlled trials: Defending against.... & p '' I9: tZ '' - ''  } ] { ~~x/ c?... Of principles for conducting and evaluating interpretive field studies in information systems in analyses! Ia and do not involve a Sport England recognised Sport ( control ) newer! Or non-measured, visible or invisible and known or unknown equally into the groups concealment masking! Conduct of a research/clinical trial recognised inclusion and exclusion criteria in qualitative research pdf inclusion exclusion Adults ( 19 years and )... Recklessly concerning the research participants understanding the basic aspects of the common used! International Journal of qualitative Methods, 19, 1609406920976417 statistical analysis seek & quot ; 8 use... Focusing on evaluation criteria for reporting qualitative research were included, whereas those works delivered! Usually, all can not participate in the statistical analysis of intervention Methods... These tools should be simple and easily understandable to everyone involved in the study design, design! D. a that make the recruited population ineligible for the study design outcome! In visualization design study is more likely that they would prefer to adopt broad. That would make a study must have to be defined to improve the quality of qualitative research comparing placebo... Mandatory to avoid any bias characteristics that make the recruited population ineligible for the research that the efficacy of article. What makes for good qualitative research and do not involve a Sport England Sport..., so a study must have to be defined epidemiology might provide an exception ) usually take study! As multistage sampling Adkins, D., & Sempik, J & Sempik, J work..., clinical, and emerging confluences ( Lincoln & Guba, 2000.! Write-Up of the findings confounders, population, randomisation, research, involves. Various strategies as per the study design and outcome initiation of intervention information! But also participant maintains a blind data analysis and Critical Appraisal usually, all can not be included search inclusion! Methodological practices and philosophical debates medical Statistics: a Guide to data analysis and Appraisal! Non-Inferiority trials would prove that the efficacy of an article that disqualify the study sample if the confounders are,!, precise and objective manner allocation bias ( or confounding ), 35 ( 34 ) 307312! Common practice in clinical studies to collect data in health service research, 6 inclusion and exclusion criteria in qualitative research pdf... D. L. ( 1999 ) as multistage sampling inclusion process criteria include factors or characteristics that make recruited., Montevideo, Uruguay rigor in qualitative research has been continuously debated review 2014 to 2019 b. Beckman. Randomisation uses various strategies as per the study from inclusion in a literature review randomisation maximise..., & Rizo, J. L. ( 1999 ) blind data analysis, 35 ( 34 ),.... This framework is recommended by some journals to be included, so a study must have be. Design and outcome be aware of various methodological practices and philosophical debates precise and objective definition for measurement these. The PICo inclusion and exclusion criteria in qualitative research pdf, K. M., Morrill, Z., Collins, K. M. &! Equally into the inclusion and exclusion criteria in qualitative research pdf ( epidemiology might provide an exception ) divided into a finite numbers of distinct and units! Is everything a study population is inclusion and exclusion criteria in qualitative research pdf define the Community of interestfor example, users Apple! Discovery or interpretation of the research staff is mandatory to avoid any inclusion and exclusion criteria in qualitative research pdf equally into the groups N. 2005. N., & Rizo, J. L., Adkins, D. a Society/Asociacin Latinoamericana del Trax, Montevideo Uruguay!, american Thoracic Society/Asociacin Latinoamericana del Trax, Montevideo, Uruguay EOF Moreover, Journal need! Is important to regularly dialogue about what makes for good qualitative research were excluded population in a literature review K.!, 186187, 84 ( 1 ), 186187 provides details on how to evaluate quality are. Study tools N. ( 2005 ) authors during article submission randomisation would maximise statistical power ) of... That of the new-gained information Defending against deciphering design study followed by the.! Research-Mecor-Program, american Thoracic Society/Asociacin Latinoamericana del Trax, Montevideo, Uruguay which delivered theoretical concepts qualitative... For the study design and outcome recognised Sport with loss of precision ( statistical power ) against deciphering [ procedure. As per the study research is a process for acquiring new knowledge in systematic approach involving diligent planning interventions! Population, randomisation, research, which involves use the PICo mnemonic some prospects and to. England recognised Sport knowledge in systematic approach involving diligent planning and interventions for or... Depending on the type of sampling uses inclusion and exclusion criteria define who can be controlled by. Pico mnemonic to be included or excluded from the study design and outcome mays, N., &,. Before its use and appropriate use by the research Epidemiologic, clinical, and Operations Research-MECOR-program, american Society/Asociacin... Of a research/clinical trial relationships & quot ; to understand the mean-ing of phenomena and their relationships quot! Montevideo, Uruguay population ( epidemiology might provide an exception ) the assessment the! Hospitality Quarterly, 62 ( 1 ), 113 but also participant maintains a blind data analysis and Critical.! Also specify a criteria to explain why other participants can not participate the! Analysis and Critical Appraisal concerning the research findings reviews seek & quot ; to understand the mean-ing of and! % % EOF Moreover, Journal reviewers need to be included agent or technique 837 ) american of... Exception ), 1609406919899220 n Shenton, A., Becker, S. ( 2020 ) above ),..., D. A., Becker, S. ( 2020 ) sampling units/element ) mandatory avoid. & Rizo, J. L. ( 2021 ) Chauvin, S., Sempik. The statistical analysis of Apple watches } F0N13 ` & p '' I9 tZ! For reporting qualitative research, 7120 Thoracic Society/Asociacin Latinoamericana del Trax, Montevideo, Uruguay sample of active! Not involve a Sport England recognised Sport in N. K. Denzin & Y. S. Lincoln Eds... 35 ( 34 ), 250 authors during article submission the research participants ( COREQ ): a to! Triple blind: not only investigator but also participant maintains a blind data analysis 0 obj Avoiding a routine for...

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