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Medication-induced nausea assessment questionnaire and analysis of the factors that contribute to the manifestation of nausea

dc.contributor.advisorJanković, Slobodan
dc.contributor.otherMilovanović, Jasmina
dc.contributor.otherKostić, Marina
dc.contributor.otherVeličković Radovanović, Radmila
dc.creatorProkić, Anđelka
dc.date.accessioned2019-05-30T12:15:34Z
dc.date.available2019-05-30T12:15:34Z
dc.date.available2020-07-03T15:20:22Z
dc.date.issued2019-02-22
dc.identifier.urihttp://nardus.mpn.gov.rs/handle/123456789/11139
dc.identifier.urihttp://eteze.kg.ac.rs/application/showtheses?thesesId=6686
dc.identifier.urihttps://fedorakg.kg.ac.rs/fedora/get/o:1115/bdef:Content/download
dc.description.abstractUVOD. Mučnina, neprijatan osećaj u predelu grla i/ili želuca, koji može i ne mora dovesti do povraćanja, je svesno prepoznavanje podsvesne ekscitacije u oblasti medule, blisko udružene sa delovima centra za povraćanje. Mučnina može biti uzrokovana: iritativnim impulsima iz gastrointestinalnog trakta, impulsima koji potiču iz donjih moždanih struktura, povezanim sa bolešću vožnje i impulsima iz cerebralnog kortkesa. Lekovi izazivaju mučninu u različitoj meri, što je od značaja kada treba izabrati terapiju kod pacijenta koji mučninu teško podnose i skloni su odustajanju od dalje terapije. Apstraktne koncepte (kakav je i mučnina) je teško kvantitativno izmeriti, i u tu svrhu koristimo upitnike. CILjEVI RADA. Studija je imala tri cilja: (1) prevođenje i transkulturološka validacija dela upitnika o gastrointestinalim simptomima iz ugla pacijenta (PROMISGSS deo koji se odnosi na mučninu i povraćanje); (2) razvoj i ispitivanje sopstvenog upitnika za procenu mučnine posle primene lekova, kroz utvrđivanje pouzdanosti, validaciju i faktorsku analizu; (3) utvrđivanje faktora koji doprinose prekidu terapije zbog ekstremne mučnine kod pacijenata na terapiji gvožđem. METODOLOGIJA. Skala koja meri gastrointestinalne simptomime iz ugla pacijenta (PROMIS-GSS deo koji se odnosi na mučninu i povraćanje), prevedena je na srpski jezik i izvršena je transkulturološka validacija iste. Prevod i kulturološka adaptacija skale urađena je u skladu sa preoprukama datim u ISPOR (International Society for Pharmacoeconomics and Outcomes Research) vodiču. Razvijen je i sopstveni upitnik za procenu mučnine posle primene lekova (DINS-Drug Induced Nausea Scale), utvrđeni su njegova pouzdanost, validnost i sprovedena faktorska analiza. Ispitivanje pouzdanosti upitnika obavljeno je kroz određivanje koeficijentaIV Kronbahova alfa za ceo upitnik, Spirman-Braunovog koeficijenta i srednje vrednosti i varijanse za svako pitanje iz upitnika. Punovažnost sadržaja upitnika evaluirala je grupa stručnjaka nezavisna od istraživača. Punovažnost povezana sa kriterijumom je testirana pomoću tri metode: poređenjem novog upitnika kada su ovaj popunili istraživači i pacijenti samostalno; konvergentna validnost je testirana poređenjem skora novog upitnika sa skorom PROMIS-GSS nausea; divergentna validnost testitrana je poređenjem skora novog upitnika sa skorom upitnika Netolerancije neizvesnosti (Intolerance Uncertanity). Analiza glavnih komponenti upitnika rađena je da bi se otkrili glavni faktori koje upitnik meri. Pogodnost upitnika i uzorka za faktorsku analizu testirana je pomoću Bartletovog testa sferičnosi i Kajzer-Mejer-Olkinovog testa adekvatnosti uzorkovanja. Faktori su ekstrahovani prvo bez rotacije, uz uslov da brojka koja označava količinu informacija koju nosi jedan faktor (eigenvalue) mora biti veći od 1 i korišćenjem Scree plot (ekstrahovani faktori bili su iznad ,,lakta“ dijagrama). Potom su referentne ose rotirane ortogonalno Varimaks metodom i urađena je još jedna ekstrakcija faktora, koristeći iste kriterijume kao za nerotirajuće rešenje. Vremenska stabilnost novog upitnika i PROMIS-GSS nauseaupitnika testirani su drugim popunjavanjem upitnika , koje su istraživači obavili dve nedelje posle prve posete apoteci. Prisustvo i stepen mučnine izazvane preparatima gvožđa meren je DINS-om. Studija je dizajnirana kao opservaciona, a metodologija rada je podrazumevala studiju preseka. Uzorak pacijenata je bio uzastopan tj. u studiju su uključeni svi pacijenti koji su posetili apoteku tokom trajanja studije (njih 128), a koristili su oralne preparate gvožđa. Anketiranje je izvršeno anonimno i na dobrovoljnoj osnovi. REZULTATI I ZAKLjUČCI. DINS skala meri jedan fenomen, intenzitet mučnine izazvane oralnim preparatima gvožđa. Ima odličnu pouzdanost (Kronbahova alfa 0.892, kada je ocenjen od strane istraživača,Spirmanov koeficijent 0.965; (p<0.001)) i vremensku stabilnost (Kronbahova alfa posle ponovljenog ocenjivanja bila je 0.901). DINS instrument pokriva suštinske aspekte mučnine, koji takođe mogu biti uključeni u fenomene gađenja i povraćanja: pojava (pitanje 2), učestalost (pitanje 3), trajanje (pitanje 1) i ozbiljnost (pitanja 4 i 5) Ovo istraživanje otkrilo je samo dva faktora za statistički značajnim uticajem na učestalost i stepen mučnine posle oralne primene preparata gvožđa: unos kafe i istorija gastroinestinalnih bolesti. U ovom istraživanju nije nađena veza između tipa soli gvožđa, dnevne doze ili doznog režima sa težinom mučnine. Prevođenjem i validacijom upitnika za merenje mučnine, kao i stvaranjem novog upitnika za merenje mučnine izazvane lekovima stvoreni su uslovi da se u kliničkoj praksi proceni u kojoj meri lek koji se uvodi u terapiju stvara gastrointestinalne tegobe kod pacijenta, te da li je neophodno odustajanje od terapije tim lekom i uvođenje drugog leka. KLjUČNE REČI. Upitnik; mučnina; preparati gvožđa; DINS; PROMISsr
dc.description.abstractINTRODUCTION. Nausea, an unpleasant feeling in the throat and/or the stomach, which may or may not lead to vomiting, represents conscious awareness of the subconscious excitation in the medulla area, close to the brain’s vomiting center. Nausea can be caused by: irritative impulses in the gastrointestinal tract, impulses originating from the lower brain structures responsible for motion sickness, and impulses originating from the cerebral cortex. Medication can cause varying degrees of nausea. Abstract concepts such as nausea are difficult to measure quantitatively, so in order to do so, we use questionnaires. AIMS. The translation and transcultural validation of the part of the questionnaire dealing with gastrointestinal symptoms from the patient’s perspective (PROMIS-GSS), the part dealing with nausea and vomiting; The development and testing of the medication-induced nausea assessment questionnaire, determining its reliability, validation, and factorial analysis; Determining the factors which contribute to a cessation of treatment due to extreme nausea in patients taking iron supplements. A separate medication-induced nausea assessment questionnaire was developed (DINS-Drug Induced Nausea Scale). This instrument was factorially analyzed and has been determined to be reliable and valid. An interesting phenomenon was observed – medication-induced nausea, which is the most common reasonfor the cessation of otherwise effective treatments. A new nausea assessment questionnaire was developed according to the guidelines established by Robert F. The questionnaire’s reliability was assessed through calculation of: Cronbach’s alpha for the questionnaire as a whole, the Spearman-Brown coefficient and the average values and variance for each individual question found in the questionnaire. The validity of the questionnaire was evaluated by an independent panel consisting of three medical specialists from the Clinical Centre of Kragujevac. Criteria validity was tested according tothree methods: a) the new questionnaire was filled out by researchers and patients independently and the results compared; b) convergent validity was tested by comparing the scores of the new questionnaire with the scores of PROMIS-GSS nausea; and c) divergent validity was tested by comparing the scores of the new questionnaire with the scores of Intolerance of Uncertainty. Main component analysis was performed in order to ascertain the main factors assessed by the questionnaire. The suitability of the questionnaire and the samples for factorial analysis were tested using Bartlett’s sphericity test and the Kaiser-Meyer-Olkin Measure of Sampling Adequacy. The factors were extracted first without rotation, under the condition that the number denoting the amount of information carried by a single factor (the eigenvalue) must be greater than 1 and by using the Scree plot (the extracted factors were above the “elbow” of the diagram). Then the referential axes were rotated orthogonally using the varimax rotation method and a second factor extraction was performed using the same criteria as for the non-rotating solution. The test-retest reliability of this questionnaire and the PROMIS-GSS nausea questionnaire were tested by having the researchers fill out a second questionnaire two weeks after the initial visit to the pharmacy. The patients were tested over thetelephone in thesecond instance. The presence and degree of nausea caused by the iron supplements was tested by the DINS test. The study was designed to be observable. This was a cross-sectional study. The patient sample was consecutive, meaning that all patients who visited the pharmacy during the course of the study (128 of them) were included, provided they used oral iron supplements. The questionnaire was filled out anonymously by volunteers. RESULTS AND CONCLUSIONS. The DINS scale measures a single phenomenon - the intensity of nausea caused by oral iron supplements. It is highly reliable (Cronbach’s alpha 0.892, when graded by researchers) and has great test-retest reliability (Spearman’s rank correlation coefficient 0.965; (p<0.001) and Cronbach’s alpha was 0.901 after being graded a second time). The DINS instrument covers the essential aspects of nausea, which can also be a part of the phenomena of queasiness and vomiting: presence (question 2), frequency (question 3), length (question 1) and seriousness (questions 4 and 5).VIII This research reveals that only two factors have a statistically significant impact on the frequency and degree of nausea after oral ingestion of iron supplements: ingestion of coffee and a history of gastrointestinal disease. No connection was found between the type of ferrous salts, daily dosage or the dosage regiment and the degree of nausea. By translating and validating a questionnaire for measuring nausea, and by creating a new questionnaire for measuring drug-induced nausea, conditions have been created to assess in clinical practice the extent to which the drug introduced into the therapy produces gastrointestinal complaints in the patient, and whether it is necessary to discontinue therapy the drug and the introduction of another drug.en
dc.formatapplication/pdf
dc.languagesr
dc.publisherУниверзитет у Крагујевцу, Факултет медицинских наукаsr
dc.rightsopenAccessen
dc.sourceУниверзитет у Крагујевцуsr
dc.subjectUpitniksr
dc.subjectQuestionnaireen
dc.subjectnauseaen
dc.subjectiron supplementsen
dc.subjectDINSen
dc.subjectPROMISen
dc.subjectmučninasr
dc.subjectpreparati gvožđasr
dc.subjectDINSsr
dc.subjectPROMISsr
dc.titleUpitnik za procenu mučnine posle primene lekova i analiza faktora koji doprinose nastanku mučninesr
dc.title.alternativeMedication-induced nausea assessment questionnaire and analysis of the factors that contribute to the manifestation of nauseaen
dc.typedoctoralThesis
dc.rights.licenseBY-ND
dc.identifier.fulltexthttp://nardus.mpn.gov.rs/bitstream/id/50198/Andjelka_Prokic-Medicina.pdf
dc.identifier.fulltexthttp://nardus.mpn.gov.rs/bitstream/id/50197/Disertacija.pdf


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