Methodological Quality of an Article for Treatment in Early Ductal Decompression versus Conservative Treatment in Gallstone Pancreatitis with Ampullary Obstruction
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Abstract
Early ductal decompression in the treatment of acute biliary pancreatitis with ampullary obstruction is controversial. The objective of this study is to determine the methodological quality, internal and external validity of the article of Acosta et al. (2006), which compares the effectiveness of early ductal decompression versus conservative management in acute biliary pancreatitis with ampullary obstruction. Acosta et al. (2006), article was subjected to a therapy User’s Guide. Subsequently its methodological quality was analyzed applying 3 instruments; MINCIR therapy, CONSORT and SIGN. The application of these instruments was performed independently by four researchers, trained in critical analysis of the literature and clinical epidemiology. The article is not oriented to a definite question. It has a random assignment of participants, but these were not properly considered until the end of the study. It has 16 points of MINCIR scale (cut-off of the methodological quality construct is 18). It complies with only 10 of the 21 items of CONSORT. All instruments used put into evidence similar methodological weaknesses that lead to questioning of the internal and external validity of the study, a fact that in turn questions the logic of the applicability of this protocol.
References
Acosta, J. M.; Katkhouda, N.; Debian, K. A.; Groshen, S. G.; Tsao-Wei, D. D. & Berne, T. V. Early ductal decompression versus conservative management for gallstone pancreatitis with ampullary obstruction: a prospective randomized clinical trial. Ann. Surg., 243(1):33-40, 2006.
Altman, D. G.; Schulz, K. F.; Moher, D.; Egger, M.; Davidoff, F.; Elbourne, D.; Gøtzsche, P. C.; Lang, T.; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann. Intern. Med., 134(8):663-94, 2001.
Ayub, K.; Slavin, J. & Imada, R. Endoscopic retrograde cholangiopancreatography in gallstone-associated acute pancreatitis. Cochrane Database Syst. Rev., (1):CD003630, 2010.
Baron, T. H. & Morgan, D. E. Acute necrotizing pancreatitis. N. Engl. J. Med., 340(18):1412-7, 1999.
Bradley, E. L. 3rd. & Allen, K. A prospective longitudinal study of observation versus surgical intervention in the management of necrotizing pancreatitis. Am. J. Surg., 161(1):19-24, 1991.
Fölsch, U. R.; Nitsche, R.; Lüdtke, R.; Hilgers, R. A. & Creutzfeldt, W. Early ERCP and papillotomy compared with conservative treatment for acute biliary pancreatitis. The German Study Group on Acute Biliary Pancreatitis. N. Engl. J. Med., 336(4):237-42, 1997.
Lankisch, P. G. Epidemiology of acute pancreatitis. In: Malfertheimer, P. (Ed.). Acute Pancreatitis: Novel concepts in biology and therapy. 1st ed. Berlin, Blackwell Science, 1999. pp.145-53.
Manterola, D. C.; Pineda N. V.; Vial G. M. & Losada M. H. Revisión crítica de la literatura para artículos de terapia. Rev. Chil. Cir., 56(6):604-9, 2004.
Manterola, C.; Busquets, J.; Pascual, M. & Grande, L. ¿Cuál es la calidad metodológica de los artículos sobre procedimientos terapéuticos publicados en cirugía española? Cir. Esp., 79(2):95-100, 2006.
Manterola, C.; Pineda, V.; Vial, M.; Losada, H. & Muñoz, S. Surgery for morbid obesity: selection of operation based on evidence from literature review. Obes. Surg., 15(1):106-13, 2005a.
Manterola, C.; Pineda, V. & Vial, M. Resección abierta frente a laparoscópica en el cáncer de colon no complicado. Revisión sistemática. Cir. Esp., 78(1):28-33, 2005b.
Martínez, J. & Llanos, O. Evolución y complicaciones de la pancreatitis aguda. Bol. Esc. Med. U. C., 21:196-201, 1992.
Meakins, J. L. Innovation in surgery: the rules of evidence. Am. J. Surg., 183(4):399-405, 2002.
Network, A. D. S. I. G. Sign 50: a guidelines developers’ handbook. Edinburgh, Sign, 2004.
Rau, B.; Uhl, W.; Buchler, M. W. & Beger, H. G. Surgical treatment of infected necrosis. World J. Surg., 21(2):155-61, 1997.
Rollan, A. Patogenia de la pancreatitis aguda. Bol. Esc. Med. Pontif. Univ. Catol. Chile, 21:185-8,1992.
Sackett, D. L. Rules of evidence and clinical recommendations on the use of antithromboti cagents. Chest, 89(2 Suppl.):2S-3S, 1986.
Sackett, D. L. & Wennberg. J. E. Choosing the best research design for each question. B. M. J., 315(7123):1636, 1997.
Sharma, V. K. & Howden, C. W. Metaanalysis of randomized controlled trials of endoscopic retrograde cholangiography and endoscopic sphincterotomy for the treatment of acute biliary pancreatitis. Am. J. Gastroenterol., 94(11):3211- 4, 1999.
Steinberg, W. & Tenner, S. Acute pancreatitis. N. Engl. J. Med., 330(17):1198-210, 1994.
Swaroop, V. S.; Chari, S. T. & Clain, J. E. Severe acute pancreatitis. JAMA, 291(23):2865-8, 2004.
Tenner, S. & Banks, P. A. Acute pancreatitis: nonsurgical management. World J. Surg., 21(2):143-8, 1997.