Randomised Controlled Trial | My Assignment Tutor

CASP Randomised Controlled Trial Standard Checklist:11 questions to help you make sense of a randomised controlled trial (RCT)Main issues for consideration: Several aspects need to be considered when appraising arandomised controlled trial:Is the basic study design valid for a randomisedcontrolled trial? (Section A)Was the study methodologically sound? (Section B)What are the results? (Section C)Will the results help locally? (Section D)The 11 questions in the checklist are designed to help you think about these aspectssystematically.How to use this appraisal tool: The first three questions (Section A) are screening questionsabout the validity of the basic study design and can be answered quickly. If, in light of yourresponses to Section A, you think the study design is valid, continue to Section B to assesswhether the study was methodologically sound and if it is worth continuing with the appraisal byanswering the remaining questions in Sections C and D.Record ‘Yes’, ‘No’ or ‘Can’t tell’ in response to the questions. Prompts below all but one of thequestions highlight the issues it is important to consider. Record the reasons for your answersin the space provided. As CASP checklists were designed to be used as educational/teachingtools in a workshop setting, we do not recommend using a scoring system.About CASP Checklists: The CASP RCT checklist was originally based on JAMA Users’ guides to themedical literature 1994 (adapted from Guyatt GH, Sackett DL and Cook DJ), and piloted withhealthcare practitioners. This version has been updated taking into account the CONSORT 2010guideline (http://www.consort-statement.org/consort-2010, accessed 16 September 2020).Citation: CASP recommends using the Harvard style, i.e. Critical Appraisal Skills Programme(2020). CASP (insert name of checklist i.e. Randomised Controlled Trial) Checklist. [online]Available at: insert URL. Accessed: insert date accessed.©CASP this work is licensed under the Creative Commons Attribution – Non-Commercial- ShareA like. To view a copy of this licence, visit https://creativecommons.org/licenses/by-sa/4.0/Critical Appraisal Skills Programme (CASP) part of Oxford Centre for Triple Value Healthcare Ltd www.casp-uk.net2Study and citation: …………………………………………………………………………………………………………Section A: Is the basic study design valid for a randomised controlled trial? 1. Did the study address a clearly focusedresearch question?CONSIDER:Was the study designed to assess the outcomesof an intervention?Is the research question ‘focused’ in terms of:• Population studied• Intervention given• Comparator chosen• Outcomes measured?Yes No Can’t tello o2. Was the assignment of participants tointerventions randomised?CONSIDER:• How was randomisation carried out? Wasthe method appropriate?• Was randomisation sufficient to eliminatesystematic bias?• Was the allocation sequence concealedfrom investigators and participants?Yes No Can’t tello o o3. Were all participants who entered the studyaccounted for at its conclusion?CONSIDER:• Were losses to follow-up and exclusionsafter randomisation accounted for?• Were participants analysed in the studygroups to which they were randomised(intention-to-treat analysis)?• Was the study stopped early? If so, whatwas the reason?Yes No Can’t tello o o Section B: Was the study methodologically sound? 4.• Were the participants ‘blind’ tointervention they were given?• Were the investigators ‘blind’ to theintervention they were giving toparticipants?• Were the people assessing/analysingoutcome/s ‘blinded’?Yes No Can’t tello o oo oo o o5. Were the study groups similar at the start ofthe randomised controlled trial?CONSIDER:• Were the baseline characteristics of eachstudy group (e.g. age, sex, socio-economicgroup) clearly set out?• Were there any differences between thestudy groups that could affect theoutcome/s?Yes No Can’t tello o o 3 6. Apart from the experimental intervention, dideach study group receive the same level ofcare (that is, were they treated equally)?CONSIDER:• Was there a clearly defined study protocol?• If any additional interventions were given(e.g. tests or treatments), were they similarbetween the study groups?• Were the follow-up intervals the same foreach study group?Yes No Can’t tello o o Section C: What are the results? 7. Were the effects of intervention reportedcomprehensively?CONSIDER:••What outcomes were measured, and werethey clearly specified?• How were the results expressed? Forbinary outcomes, were relative andabsolute effects reported?• Were the results reported for eachoutcome in each study group at eachfollow-up interval?• Was there any missing or incomplete data?• Was there differential drop-out between thestudy groups that could affect the results?• Were potential sources of bias identified?• Which statistical tests were used?• Were p values reported?Was a power calculation undertaken?Yes No Can’t tello o o8. Was the precision of the estimate of theintervention or treatment effect reported?CONSIDER:• Were confidence intervals (CIs) reported?Yes No Can’t tello o o9. Do the benefits of the experimentalintervention outweigh the harms and costs?CONSIDER:• What was the size of the intervention ortreatment effect?• Were harms or unintended effectsreported for each study group?• Was a cost-effectiveness analysisundertaken? (Cost-effectiveness analysisallows a comparison to be made betweendifferent interventions used in the care ofthe same condition or problem.)Yes No Can’t tello o o 4Section D: Will the results help locally? 10. Can the results be applied to your localpopulation/in your context?CONSIDER:• Are the study participants similar to thepeople in your care?• Would any differences between yourpopulation and the study participants alterthe outcomes reported in the study?• Are the outcomes important to yourpopulation?• Are there any outcomes you would havewanted information on that have not beenstudied or reported?• Are there any limitations of the study thatwould affect your decision?Yes No Can’t tello o o11. Would the experimental intervention providegreater value to the people in your care thanany of the existing interventions?CONSIDER:• What resources are needed to introducethis intervention taking into account time,finances, and skills development or trainingneeds?• Are you able to disinvest resources in oneor more existing interventions in order tobe able to re-invest in the newintervention?Yes No Can’t tello o o APPRAISAL SUMMARY: Record key points from your critical appraisal in this box. What is yourconclusion about the paper? Would you use it to change your practice or to recommend changes tocare/interventions used by your organisation? Could you judiciously implement this interventionwithout delay?

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