The processes reviewed can relate to participant enrolment, consent, eligibility, and allocation to study groups; adherence to trial interventions and policies to protect participants, including reporting of harms (Item 22); and completeness, accuracy, and timeliness of data collection.
The auditor (Canada Research Chair Linda Li) will independently verify participant enrolment, consent, eligibility and allocation to study groups; adherence to trial protocols, adherence to policies to protect participants, including reporting of harms; and completeness, accuracy and timeliness of data collection.
In many jurisdictions, eligibility for, and allocation of, home care services is directed toward addressing physical needs - mental health problems must be the secondary diagnosis in order to be eligible [ 63].
Selection bias at recruitment will be avoided by separating the processes of determining patient eligibility and treatment allocation and by using random permuted blocks overseen by the CTU, not allowing physiotherapists assessing and treating patients to predict the next allocation in their clinic.
An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible.
This is an eleven-item critical appraisal tool which assesses documentation of eligibility, subject allocation and randomisation, subject assessment and blinding, subject follow-up, data assessment and analysis.
The allocation centre finally decided eligibility and inform registration confirmation and allocation results to the facilities by fax within 48 h of the reception.
An expert panel of CP specialists (gastroenterologists, surgeons and radiologists) will oversee the assessment of eligibility and will ensure that allocation to either treatment arm is possible prior to randomization.
An Expert Panel of CP specialists (gastroenterologists, surgeons, pain specialists and radiologists) will oversee the assessment of eligibility and will ensure that allocation to either treatment arm is possible prior to randomization.
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.
Allocation was concealed from those assessing eligibility and recruiting patients, with eligible patients allocated remotely via e-mail by the trial statistician.
