Razvoj i ispitivanje punovažnosti upitnika za merenje mučnine izazvane lekovima
Sažetak
Uvod/Cilj. Do sada je objavljeno nekoliko upitnika za merenje intenziteta mučnine posle primene lekova, ali su oni ili suviše specifični za određenu grupu lekova (npr. oni koji mere mučninu posle primene hemioterapije) ili njihova pouzdanost i punovažnost nisu propisno ispitani. Cilj ove studije je bio da se razvije upitnik za merenje mučnine izazvane lekovima i ispitaju njegova pouzdanost i punovažnost. Metode. Studija je bila dizajnirana kao studija preseka za procenu pouzdanosti i validnosti upitnika. Upitnik sa pet pitanja i ponuđenim odgovorima po Likertovoj skali bio je razvijen na dva nestrukturirana sastanka istraživačkog tima. Pouzdanost, punovažnost i stabilnost u vremenu ovog upitnika su ispitani na uzorku od 128 vanbolničkih bolesnika koji su uzimali oralne preparate gvožđa. Rezultati. Krajnja verzija Upitnika za mučninu izazvanu lekovima (UMIL) sa pet pitanja je pokazala odličnu pouzdanost, kako kada su upitnike popunjavali istraživači za vreme intervjua sa bolesnicima (Kronbahov alfa koeficijent 0,892), tako i kada su upitnike popunjavali samo bolesnici (Kronbahov alfa koeficijent 0,897). Upitnik je bio stabilan u vremenu, a testovi konvergentne i divergentne punovažnosti su dali vrlo dobre rezultate. Faktorska analiza je otkrila samo jedan faktor, što znači da ceo upitnik meri samo jedan fenomen, intenzitet mučnine, kako je originalno i nemeravano. Zaključak. Upitnik UMIL je pouzdan i punovažan instrument za merenje intenziteta mučnine izazvane lekovima. Otkrivanje bolesnika sa visokim stepenom mučnine izazvane lekovima pomoći će propisivačima da odluče da li terapiju treba prekinuti ili preći na manje emetogene lekove.
Reference
Hendren G, Aponte-Feliciano A, Kovac A. Safety and efficacy of commonly used antiemetics. Expert Opin Drug MetabToxicol 2015; 11(11): 1753–67.
Turini M, Piovesana V, Ruffo P, Ripellino C, Cataldo N. An as-sessment of chemotherapy-induced nausea and vomiting direct costs in three EU countries. Drugs Context 2015; 4: 212285.
Leppert W. Emerging therapies for patients with symptoms of opioid-induced bowel dysfunction. Drug Des Devel Ther 2015; 9: 2215–31.
Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One 2015; 10(2): e0117383.
Geisser P, Burckhardt S. The pharmacokinetics and pharmaco-dynamics of iron preparations. Pharmaceutics 2011; 3(1): 12–33.
Martin CG, Rubenstein EB, Elting LS, Kim YJ, Osoba D. Meas-uring chemotherapy‐induced nausea and emesis. Cancer 2003; 98(3): 645–55.
Pereira DI, Couto Irving SS, Lomer MC, Powell JJ. A rapid, sim-plequestionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation. BMC Gastroenterol 2014; 14: 103.
Spiegel BM, Hays RD, Bolus R, Melmed GY, Chang L, Whitman C, et al. Development of the NIH Patient-Reported Out-comes Measurement Information System (PROMIS) gastroin-testinal symptom scales. Am J Gastroenterol 2014; 109(11): 1804-14.
DeVellis RF. Scale Development, Theory and Applications. 2nd ed. Newbury Park: SAGE Publications; 2003.
Morrow GR, Navari RM, Rugo HS. Clinical roundtable mono-graph: new data in emerging treatment options for chemother-apy-induced nausea and vomiting. Clin Adv Hematol Oncol 2014; 12(3 Suppl 9): 1–14; quiz 15.
Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, et al. ISPOR Task Force for Translation and Cul-tural Adaptation. Principles of Good Practice for the Transla-tion and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health 2005; 8(2): 94–104.
Streiner DL, Norman GR. Health Measurement Scales - a prac-tical guide to their development and use. 4st ed. Oxford: Ox-ford University Press; 2008.
Badia X, Arribas F, Ormaetxe JM, Peinado R, de Los Terreros MS. Development of a questionnaire to measure health-related quality of life (HRQoL) in patients with atrial fibrilla-tion (AF-QoL). Health Qual Life Outcomes 2007; (5): 37.
Mihić Lj, Sokić J, Samac N, Ignjatović I. Serbian adaptation and validation of the Intolerance of Uncertainty Scale. Primenjena psihologija 2014; 7(Suppl): 347–70. (Serbian)
Khanna D, Hays RD, Shreiner AB, Melmed GY, Chang L, Khan-na PP, et al. Responsiveness to Change and Minimally Im-portant Differences of the Patient-Reported Outcomes Meas-urement Information System Gastrointestinal Symptoms Scales. Dig Dis Sci 2017; 62(5): 1186–92.
Brearley SG, Clements CV, Molassiotis A. A review of patient self-report tools for chemotherapy-induced nausea and vomit-ing. Support Care Cancer 2008; 16(11): 1213–29.
Phillips RS, Friend AJ, Gibson F, Houghton E, Gopaul S, Craig JV, et al. Antiemetic medication for prevention and treatment of chemotherapy-induced nausea and vomiting in childhood. Cochrane Database Syst Rev 2016; 2: CD007786.