Title Intervencije za liječenje postoperativne boli u djece : analiza dokaza o djelotvornosti, sigurnosti i domenama ishoda
Title (english) Interventions for the treatment of postoperative pain in children : analysis of the evidence on efficacy, safety and outcome domains
Author Krste Borić
Mentor Livia Puljak (mentor)
Committee member Ivana Kolčić (predsjednik povjerenstva)
Committee member Ana Jerončić (član povjerenstva)
Committee member Aleksandar Džakula (član povjerenstva)
Granter University of Split School of Medicine Split
Defense date and country 2018, Croatia
Scientific / art field, discipline and subdiscipline BIOMEDICINE AND HEALTHCARE Clinical Medical Sciences
Universal decimal classification (UDC ) 616 - Pathology. Clinical medicine
Abstract Ciljevi: Ciljevi istraživanja bili su: provesti pregled sustavnih pregleda o djelotvornosti i sigurnosti intervencija za liječenje postoperativne boli u djece te napraviti sintezu dokaza, analizirati domene ishoda u sustavnim pregledima i randomiziranim kontroliranim pokusima (engl. randomized controlled trial – RCT) koji su analizirali intervencije za liječenje postoperativne boli u djece te ih usporediti s preporučenim glavnim skupom ishoda inicijative PedIMMPACT (engl. Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) te na koncu provesti anketu o svjesnosti i prihvaćenosti preporučenog glavnog skupa ishoda među autorima sustavnih pregleda i RCT-ova.
Metodologija: U prvom dijelu istraživanja napravljen je pregled sustavnih pregleda o postoperativnoj boli u djece. Sveobuhvatnom strategijom pretraživanja pretraženo je 6 elektroničkih pismohrana. Dva autora su za svaku studiju neovisno vadili podatke iz članaka. Analizirana je efikasnost i sigurnost pojedinih intervencija, obilježja samih studija kao i njihova metodološka kvaliteta pomoću ljestvice AMSTAR. U drugom i trećem dijelu istraživanja su, nakon obnovljene strategije pretraživanja pomoću koje su pronađena 3 nova sustavna pregleda analizirani ishodi korišteni u sustavim pregledima i u RCT-ovima koji su u njih bili uključeni te uspoređeni s preporučenim ishodima inicijative PedIMMPACT. Za ovo istraživanje također su dva autora neovisno vadila podatke. U posljednjem dijelu istraživanja anketirani su autori analiziranih sustavnih preglednih članaka i RCT-ova kako bi se istražilo njihovo znanje i stavovi prema domenama ishoda koje preporučuje PedIMMPACT.
Rezultati: Visokom metodološkom kvalitetom ocijenjeno je 38% sustavnih preglednih članaka o liječenju postoperativne boli u djece, 55% srednjom i 7% niskom kvalitetom. Pozitivno uvjerljiv dokaz o uspješnoj efekasnosti intervencije pronađen je u 18 sustavnih preglednih članaka dok je pozitivno uvjerljiv dokaz o sigurnosti intervencije pronađen u 14 sustavnih preglednih članaka. Medijan broja svih ishoda u uključenim sustavnim preglednim člancima bio je 4, dok je medijan ishoda preporučenih od strane PedIMMPACT inicijative bio 3. Najčešće opisani PedIMMPACT ishod bio je „nuspojave“, dok je drugi najčešći bio „intenzitet boli“. Nešto više od polovine preglednih članaka koji su analizirali intenzitet boli opisali su alat kojim su mjerili bol. Medijan svih ishoda u uključenim randomiziranim kontroliranim člancima je 5 dok je medijan PedIMMPACT ishoda 2. Najčešće korišten PedIMMPACT ishod bio je „intenzitet boli“ kojeg prate „nuspojave“. Ostala 4 PedIMMPACT ishoda opisana su u manje od 30% uključenih studija. Najčešći ishod koji nije dio preporučenih ishoda PedIMMPACT inicijative bio je „dodatna analgezija“ koja je analizirana u 71% studija. Nije bilo značajne statističke razlike u udjelu PedIMMPACT ishoda u studijama objavljenim prije i poslije objave preporuka. Najčešći alat za mjerenje intenziteta boli bila je vizualno-analogna ljestvica (24%). Samo trećina autora sustavnih preglednih članaka i randomiziranih kontroliranih pokusa o postoperativnoj boli u djece znaju za preporuke PedIMMPACT inicijative. Kao razloge ne korištenja preporučenih ishoda navode nedostatak informiranosti, poteškoće sa implementacijom te manjak resursa.
Zaključak: Pozitivno uvjerljivo ocijenjene su sve intervencije koje su bile u skladu sa smjernicama za liječenje akutne bolni što upozorava na važnost pridržavanja smjernicama. Metodološka kvaliteta pronađenih sustavnih pregleda je varirala, a Cochraneovi pregledi imali su veću kvalitetu pa su samim time i korisniji kliničarima. Autori sustavnih pregleda i primarnih studija koje analiziraju intervencije za liječenje postoperativne boli u djece ne predržavaju se preporučenog glavnog skupa ishoda što otežava usporedbu, sintezu rezultata i izradu meta-analiza. Razlog nekorištenja preporučenog skupa ishoda za akutnu bol djece je u tome što većina autora nije nikad čula za inicijativu PedIMMPACT , a oni koji su čuli nedovoljno poznaju njene preporuke. Također su naveli razloge zbog kojih je implementacija smjernica otežana. Nužno je provesti daljnja istraživanja kako bi se vidjelo treba li revidirati preporučeni skup ishoda za akutnu bol djece i kako potaknuti autore da ga koriste.
Abstract (english) Aims: The aim of the first part of the study was to conduct an overview of systematic reviews that summarizes the results about efficacy and safety from randomized controlled trials involving the various strategies used for postoperative pain management in children. Second and third goal was to investigate the range of efficacy and safety outcomes used in systematic reviews (SRs) of randomized controlled trials (RCTs) of interventions for postoperative pain in children and compare them with outcome domains recommended in the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (PedIMMPACT). And the last aim was to analyze awareness about and acceptability of core outcome set (COS) for pediatric pain recommended by the PedIMMPACT.
Methods: The first part of the study was an overview of systematic reviews. Six databases were searched from the earliest date to January 24, 2016. Two authors independently assessed the methodological quality of included reviews. A Measurement Tool to Assess Systematic Reviews (AMSTAR) quality assessment tool was used. In the second and third part of the study efficacy and safety outcomes were extracted from included systematic reviews and RCTs. The type and number of outcomes were analyzed and compared against the outcomes recommended by PedIMMPACT. In the last part of the study authors of systematic reviews and RCTs about interventions for postoperative pain in children were surveyed regarding their knowledge, attitudes and usage of the PedIMMPACT COS.
Results: Out of 45 systematic reviews that investigated various interventions for postoperative pain in children, 19 systematic reviews (42%) presented conclusive evidence of efficacy. Positive conclusive evidence was reported in 18 systematic reviews (40%). More than half of systematic reviews included in this overview were rated as having medium methodological quality. Of 45 included systematic reviews, 10 were Cochrane reviews and they had higher methodological quality than non-Cochrane reviews. The median number of all outcomes in SRs was 4, while the median number of the PedIMMPACT core outcomes was three out of six. The most commonly reported outcome of the PedIMMPACT COS was “symptoms and adverse events,” followed by pain intensity, which was reported in 75% of the included SRs. Just over half of the SRs that included a pain intensity outcome also indicated the specific pain assessment tool used in the methods section. Median number of reported outcomes was five (range 1 to 11) for the included RCTs and two (range 0 to 6) for PedIMMPACT. The most commonly analyzed PedIMMPACT outcome domains were pain intensity (93%) and ‘symptoms and adverse events’ (83%). The remaining four PedIMMPACT outcomes were present in under 30% of included randomized controlled trials. There was no significant difference in the proportion of PedIMMPACT outcome domains’ use in RCTs published before or after the PedIMMPACT core outcome set. Only a third of surveyed authors of systematic reviews and randomized controlled trials about postoperative pain in children had heard about the PedIMMPACT COS for acute pediatric pain. Problems indicated as preventing them from using the COS were lack of awareness, difficulties with implementation, and lack of resources.
Conclusion: All analysis of positive conclusive evidence of efficacy in included SRs, except one SR, are in line with guidelines for the management of acute postoperative pain. The superior quality of Cochrane reviews compared to non-Cochrane reviews has already been reported in multiple studies so Cochrane reviews remain the “gold standard” for clinical decision-making. Systematic reviews and RCTs in the field of pediatric pain do not use the recommended COS. This makes comparisons of efficacy and safety across interventions very difficult. Further discussions about the adequacy of COS for acute pediatric pain, as well as interventions to increase the uptake of COS may be warranted.
Keywords
postoperativna bol
liječenje boli
ishod liječenja
dijete
adolescent
randomizirana kontrolirana ispitivanja
pregled literature
Keywords (english)
Postoperative Pain
Pain Management
Treatment Outcome
Child
Adolescent
Randomized Controlled Trials as Topic
Review Literature as Topic
Language croatian
URN:NBN urn:nbn:hr:171:270125
Project Number: IP-2014-09-7672 Title: Profesionalizam u zdravstvu Title: Professionalism in Health Care Acronym: ProHealth Leader: Ana Marušić Jurisdiction: Croatia Funder: HRZZ Funding stream: IP
Study programme Title: Translational Research in Biomedicine - TRIBE Study programme type: university Study level: postgraduate Academic / professional title: doktor/doktorica znanosti, interdisciplinarna područja znanosti (doktor/doktorica znanosti, interdisciplinarna područja znanosti)
Type of resource Text
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Created on 2023-05-11 13:31:01