Reliability and agreement of two smear reading scales for classification and monitoring of multidrug therapy in leprosy patients
Keywords:
leprosy/classification, therapeutics, scales, Colombia
Abstract
Introduction. After the clinical diagnosis of leprosy, classification methods are necessary to define a treatment and prognosis of patients consistent with bacterial load. Bacteria are detected in skin smear, and bacterial load typically is established by the internationally used Ridley's logarithmic scale, However, in Colombia an alternative semiquantitative scale is used.
Objective. The interobserver reproducibility was established for the Ridley and Colombia scales, and the level of correlation-matching was identified between the bacillary indices obtained in order to assess the degree of interchangeability.
Materials and methods. Standardization was attained by a reading of the smears by 2 readers with subsequent, blinded evaluation of inter-observer agreement. Each reader quantified the bacterial load of for each sample (n=325) using the Colombian and the Ridley scales. The degree of interobserver agreement was assessed with weighted kappa coefficient. The level of correlation and agreement between the measurements of the bacillary index was established with coefficient of Lin.
Results. The interobserver weighted kappa coefficient was 0.83 for the Colombia scale and 0.85 for the Ridley scale. The Lin coefficient was 0.96 for the correlation-matching of bacillary indexes.
Conclusions. Interobserver agreement obtained for both scales was excellent as the correlation-matching bacillary indices determined with both methods. With the cut-off points yielded a good level of agreement, ensuring interchangeability between the scales defining the high or low bacterial load.
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References
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2. World Health Organization. Global leprosy situation, 2009. Wkly Epidemiol Rec. 2009;84:333-40.
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8. Machin D, Campbell M, Fayers P, Pinol A. Sample size tables for clinical studies. Second edition. Oxford: Blackwell Science; 1997.
9. Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37-46.
10. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159-74.
11. Lin LI-K. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989;45:255-68.
12. World Health Organization. Shortening duration of treatment of multibacillary leprosy. Wkly Epidemiol Rec. 1997; 72: 125-32.
13. Zweig MH, Campbell G. Receiver-operating characteristic (ROC) plots: A fundamental evaluation tool in clinical medicine. Clin Chem. 1993;39:561-77.
14. National Institute or Water and Atmospheric Research. Lin's concordance. Fecha de consulta: 30 de mayo de 2011. Disponible en: http://www.niwa.co.nz/our-services/online-services/statistical-calculators/lins-concordance.
15. Awofeso N. Inventory of skin smear practices in 6 leprosy control programmes in Nigeria. Lepr Rev. 1993;64:150-6.
16. de Rijk AJ, Nilsson T, Chonde M. Quality control of skin smear services in leprosy programmes: Preliminary experience with inter-observer comparison in routine services. Lepr Rev.1985;56:177-91.
17. Balagon MF, Cellona RV, Cruz E, Burgos JA, Abalos RM, Walsh GP, et al. Long-term relapse risk of multibacillary leprosy after completion of 2 years of multiple drug therapy (WHO-MDT) in Cebu, Philippines. Am J Trop Med Hyg. 2009;81:895-9.
18. Ferreira SM, Ignotti E, Senigalia LM, Silva DR, Gamba MA. Recurrence of leprosy cases in the State of Mato Grosso, Central-West Brazil. Rev Saude Publica. 2010;44:650-7.
19. Teixeira MA, Silveira VM, França ER. Characteristics of leprosy reactions in paucibacillary and multibacillary individuals attended at two reference centers in Recife, Pernambuco. Rev Soc Bras Med Trop. 2010;43:287-92.
20. van Veen NH, Meima A, Richardus JH. The relationship between detection delay and impairment in leprosy control: A comparison of patient cohorts from Bangladesh and Ethiopia. Lepr Rev. 2006;77:356-65.
21. Norman G, Joseph G, Richard J. Validity of the WHO operational classification and value of other clinical signs in the classification of leprosy. Int J Lepr Other Mycobact Dis. 2004;72:278-83.
22. Teixeira AC, Cruvinel DL, Roma FR, Luppino LF, Resende LH, Sousa T, et al. Evaluation of the agreement between clinical and laboratorial exams in the diagnosis of leprosy. Rev Soc Bras Med Trop. 2008;41(Suppl.2):48-55.
23. World Health Organization. Expert Committee on leprosy. 7th report. Technical Report Series, 874. Geneva: WHO; 1998.
24. Georgiev GD, McDougall AC. The bacteriological examination of slit-skin smears in leprosy control programmers using multiple drug therapy: A plea for radical changes in current operational methodology. Indian J Lepr. 1987;59:373-85.
25. Croft RP, Smith WC, Nicholls P, Richardus JH. Sensitivity and specificity of methods of classification of leprosy without use of skin smear examination. Int J Lepr Other Mycobact Dis. 1998;66:445-50.
26. Groenen G, Saha NG, Rashid MA, Hamid MA, Pattyn SR. Classification of leprosy under field conditions in Bangladesh. I. Usefulness of skin-smear examinations. Lepr Rev. 1995;66:126-33.
2. World Health Organization. Global leprosy situation, 2009. Wkly Epidemiol Rec. 2009;84:333-40.
3. World Health Organization. Expert Committee on Leprosy. 6th Report, Technical Report Series 768. Geneva: WHO; 1988.
4. ILEP Federation. Improving skin smears & the reading of the bacteriological index in MDT leprosy control programmes. Guidelines and Practice Technical Bulletin. Issue No 3. 1990. Fecha de consulta: 18 de junio de 2010. Disponible en: http: http://www.ilep.org.uk/technical-advice/guidelines-practice/
5. Thangaraj RH, Yawalkar SJ. La lèpre pour les médeciens et le personnel paramédicale. Troisième édition révisée. Balá», Suisse: Ciba-Geigy SA; 1988. p. 16-23.
6. Ridley DS. Bacterial indices. In: Cochrane RG, Davey TF, editors. Leprosy in theory and practice. Bristol: John Wright and Sons Ltd.; 1964. p. 620-2.
7. Guerrero MI, León CI, Naranjo N, Orozco LC, Giraldo E, Camargo D, et al. El laboratorio en lepra: bacteriología y patología. Red Nacional de Laboratorios. Bogotá: Instituto Nacional de Salud; 1992.
8. Machin D, Campbell M, Fayers P, Pinol A. Sample size tables for clinical studies. Second edition. Oxford: Blackwell Science; 1997.
9. Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37-46.
10. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159-74.
11. Lin LI-K. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989;45:255-68.
12. World Health Organization. Shortening duration of treatment of multibacillary leprosy. Wkly Epidemiol Rec. 1997; 72: 125-32.
13. Zweig MH, Campbell G. Receiver-operating characteristic (ROC) plots: A fundamental evaluation tool in clinical medicine. Clin Chem. 1993;39:561-77.
14. National Institute or Water and Atmospheric Research. Lin's concordance. Fecha de consulta: 30 de mayo de 2011. Disponible en: http://www.niwa.co.nz/our-services/online-services/statistical-calculators/lins-concordance.
15. Awofeso N. Inventory of skin smear practices in 6 leprosy control programmes in Nigeria. Lepr Rev. 1993;64:150-6.
16. de Rijk AJ, Nilsson T, Chonde M. Quality control of skin smear services in leprosy programmes: Preliminary experience with inter-observer comparison in routine services. Lepr Rev.1985;56:177-91.
17. Balagon MF, Cellona RV, Cruz E, Burgos JA, Abalos RM, Walsh GP, et al. Long-term relapse risk of multibacillary leprosy after completion of 2 years of multiple drug therapy (WHO-MDT) in Cebu, Philippines. Am J Trop Med Hyg. 2009;81:895-9.
18. Ferreira SM, Ignotti E, Senigalia LM, Silva DR, Gamba MA. Recurrence of leprosy cases in the State of Mato Grosso, Central-West Brazil. Rev Saude Publica. 2010;44:650-7.
19. Teixeira MA, Silveira VM, França ER. Characteristics of leprosy reactions in paucibacillary and multibacillary individuals attended at two reference centers in Recife, Pernambuco. Rev Soc Bras Med Trop. 2010;43:287-92.
20. van Veen NH, Meima A, Richardus JH. The relationship between detection delay and impairment in leprosy control: A comparison of patient cohorts from Bangladesh and Ethiopia. Lepr Rev. 2006;77:356-65.
21. Norman G, Joseph G, Richard J. Validity of the WHO operational classification and value of other clinical signs in the classification of leprosy. Int J Lepr Other Mycobact Dis. 2004;72:278-83.
22. Teixeira AC, Cruvinel DL, Roma FR, Luppino LF, Resende LH, Sousa T, et al. Evaluation of the agreement between clinical and laboratorial exams in the diagnosis of leprosy. Rev Soc Bras Med Trop. 2008;41(Suppl.2):48-55.
23. World Health Organization. Expert Committee on leprosy. 7th report. Technical Report Series, 874. Geneva: WHO; 1998.
24. Georgiev GD, McDougall AC. The bacteriological examination of slit-skin smears in leprosy control programmers using multiple drug therapy: A plea for radical changes in current operational methodology. Indian J Lepr. 1987;59:373-85.
25. Croft RP, Smith WC, Nicholls P, Richardus JH. Sensitivity and specificity of methods of classification of leprosy without use of skin smear examination. Int J Lepr Other Mycobact Dis. 1998;66:445-50.
26. Groenen G, Saha NG, Rashid MA, Hamid MA, Pattyn SR. Classification of leprosy under field conditions in Bangladesh. I. Usefulness of skin-smear examinations. Lepr Rev. 1995;66:126-33.
How to Cite
1.
Colorado CL, Sánchez G, Guerrero MI, León CI. Reliability and agreement of two smear reading scales for classification and monitoring of multidrug therapy in leprosy patients. biomedica [Internet]. 2011 Mar. 31 [cited 2024 May 17];31(3):403-9. Available from: https://revistabiomedica.org/index.php/biomedica/article/view/383
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