This 11-item questionnaire is designed to collect data on eligibility criteria, random allocation, concealed allocation, similarity of baseline values, blinding of therapists and/or assessors, key outcomes, intention-to-treat analysis, between group differences, and point and variability measures.
Publications were assessed for methodological quality by recording specified eligibility criteria, method of randomisation and blinding, concealment of allocation, similarity of patients in treatment groups at baseline, variation in cointerventions received by patients throughout the trial period, whether an intention to treat analysis was performed, and the number of patients lost to follow-up.
In particular, we developed a methodology for estimating the similarity of two gene allocations in terms of the probability of obtaining them purely by chance.
Although they do so in different ways, both the ARI and the dataset association parameters quantify the degree of similarity between the allocation of genes to clusters in pairs of datasets.
The Cochrane Bone, Joint and Muscle Trauma Group's reporting quality assessment tool describes the following aspects of quality assessment which have previously been shown to be important in preventing bias [ 9]: allocation concealment, blinding, generation of allocation sequence, similarity of groups at baseline, description of outcomes, intention to treat analysis, and losses to follow-up.
Nine domains were assessed: randomization, concealment of treatment allocation, similarity of groups at baseline, eligibility criteria, blinding of outcome assessor, patient and care provider, avoidance of co interventions and intention-to-treat analysis (Table 3).
14 This scale comprises 11 questions, including randomisation, blinding procedure (patients, provider and outcome assessor), concealed treatment allocation, similarity of the important baseline characteristics, co-intervention, timing of the outcome assessment, compliance and withdrawals and intention-to-treat analysis.
In this section we assessed the trials for issues such as baseline imbalances, respect of allocation assignment, similarities between clusters, information bias, parallel non-trial interventions, changes in general living conditions and implementation of the intervention.
The Delphi scores were good for the concealed treatment allocation, the similarity of the intervention and control groups at baseline and the clarity of the specified eligibility criteria.
[ 15] Primary elements of quality assessment for trials included randomization sequence generation and allocation concealment, similarity of compared groups at baseline, blinding, completeness of outcome data and outcome reporting, and overall and differential loss to follow-up.
