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Table E-5Quality assessment of studies reporting harms of adjuvant therapies for PKU

Author, YearHarms predefined using standardized/precise definitionsSerious events precisely definedSevere events precisely definedDeaths/group specifiedActive harms collectionPassive harms collectionSpecified who collected harmsTraining/background of individuals(s) collecting harms specifiedTiming of harms collection specifiedStandard scale for harms collection usedSpecified whether reported harms encompass all events collectedNumber participants withdrawing/lost to followup reported by groupTotal number participants affected by harms specified by groupNumber for each type of harm specified by groupAnalyses for harms data specified
Humphrey 201113
Burton 201114-+++++--+-+++++
Burton 201010-----------NA---
Vernon 20106-----------+---
Burlina 200911-----------NA---
Trefz 20091-U--+++++-+++++
Lee 20087++++++++++++++U
Levy 20072-----------NA---
Lambruschini 200512----UU+---NA+NANANA
Schindeler 20073-----+---U-NA---
Matalon 20074-----------NA---
Matalon 20068-----------NA---

+= yes/positive; -=no/negative; LNAA=large neutral amino acids; NA=not applicable; U=unsure

From: Appendix E, Quality of the Literature

Cover of Adjuvant Treatment for Phenylketonuria (PKU)
Adjuvant Treatment for Phenylketonuria (PKU) [Internet].
Comparative Effectiveness Reviews, No. 56.
Lindegren ML, Krishnaswami S, Fonnesbeck C, et al.

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