Table A-6.9 Randomised controlled trial Dey 2004 Quality criteria Questions considered Yes, no, not Level reported (NR) or not applicable (NA) A. Was assignment of subjects to Was the use of randomisation reported? Yes I treatment group randomised? Was the method of randomisation reported? Yes III Was the method of randomisation I-III Yes appropriate? B. Was allocation to treatment groups Was a method of allocation concealment III Yes concealed from those responsible for reported? recruiting subjects? Was the method of allocation concealment III Yes adequate? C. Was the study double-blinded? Were subjects and investigators blinded to II-IV treatment arm? No D. Were patient characteristics and Were baseline patient characteristics and III Yes demographics similar between demographics reported? treatment arms at baseline? Were the characteristics similar between III-IV treatment arms? Yes E. Were all randomised participants Was loss to follow-up reported? Yes II included in the analysis? Was loss to follow-up appropriately accounted III-IV Yes for in the analysis? F. Was outcome assessment likely to Were all relevant outcomes measured in a III-IV Yes be subject to bias? standard, valid, and reliable way? Was outcome assessment blinded to III No treatment allocation? If outcome assessment was not blinded, were III outcomes objective and unlikely to be No influenced by blinding of assessment? G. Were the statistical methods Were the methods used for comparing results III Yes appropriate? between treatment arms appropriate? If the study was carried out at more than one IV NR site, are the results comparable for all sites? H. If appropriate, were any subgroup Were subgroup analyses reported? No III-IV analyses carried out? Were subgroup analyses appropriate? NR III-IV
Table A-6.9 Randomised controlled trial Dey 2004 Quality criteria Questions considered Yes, no, not reported (NR) or not applicable (NA) Level A. Was assignment of subjects to treatment group randomised? Was the use of randomisation reported? Yes I Was the method of randomisation reported? Yes III Was the method of randomisation appropriate? Yes I-III B. Was allocation to treatment groups concealed from those responsible for recruiting subjects? Was a method of allocation concealment reported? Yes III Was the method of allocation concealment adequate? Yes III C. Was the study double-blinded? Were subjects and investigators blinded to treatment arm? No II-IV D. Were patient characteristics and demographics similar between treatment arms at baseline? Were baseline patient characteristics and demographics reported? Yes III Were the characteristics similar between treatment arms? Yes III-IV E. Were all randomised participants included in the analysis? Was loss to follow-up reported? Yes II Was loss to follow-up appropriately accounted for in the analysis? Yes III-IV F. Was outcome assessment likely to be subject to bias? Were all relevant outcomes measured in a standard, valid, and reliable way? Yes III-IV Was outcome assessment blinded to treatment allocation? No III If outcome assessment was not blinded, were outcomes objective and unlikely to be influenced by blinding of assessment? No III G. Were the statistical methods appropriate? Were the methods used for comparing results between treatment arms appropriate? Yes III If the study was carried out at more than one site, are the results comparable for all sites? NR IV H. If appropriate, were any subgroup analyses carried out? Were subgroup analyses reported? No III-IV Were subgroup analyses appropriate? NR III-IV