CASP Randomised Controlled Trial Standard Checklist: 11 questions to help you make sense of a randomised controlled trial (RCT)<\/p>\n
Main issues for consideration: Several aspects need to be considered when appraising a randomised controlled trial:<\/p>\n
Is the basic study design valid for a randomised controlled trial? (Section A)<\/p>\n
Was the study methodologically sound? (Section B) What are the results? (Section C) Will the results help locally? (Section D)<\/p>\n
The 11 questions in the checklist are designed to help you think about these aspects systematically.<\/p>\n
How to use this appraisal tool: The first three questions (Section A) are screening questions about the validity of the basic study design and can be answered quickly. If, in light of your responses to Section A, you think the study design is valid, continue to Section B to assess whether the study was methodologically sound and if it is worth continuing with the appraisal by answering the remaining questions in Sections C and D.<\/p>\n
Record \u2018Yes\u2019, \u2018No\u2019 or \u2018Can\u2019t tell\u2019 in response to the questions. Prompts below all but one of the questions highlight the issues it is important to consider. Record the reasons for your answers in the space provided. As CASP checklists were designed to be used as educational\/teaching tools in a workshop setting, we do not recommend using a scoring system.<\/p>\n
About CASP Checklists: The CASP RCT checklist was originally based on JAMA Users\u2019 guides to the medical literature 1994 (adapted from Guyatt GH, Sackett DL and Cook DJ), and piloted with healthcare practitioners. This version has been updated taking into account the CONSORT 2010 guideline (http:\/\/www.consort-statement.org\/consort-2010, accessed 16 September 2020).<\/p>\n
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.<\/p>\n
\u00a9CASP this work is licensed under the Creative Commons Attribution \u2013 Non-Commercial- Share A like. To view a copy of this licence, visit https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/<\/p>\n
Critical Appraisal Skills Programme (CASP) part of Oxford Centre for Triple Value Healthcare Ltd www.casp-uk.net<\/p>\n
2<\/p>\n
Study and citation: …………………………………………………………………………………………………………<\/p>\n
Section A: Is the basic study design valid for a randomised controlled trial?<\/p>\n
1. Did the study address a clearly focused research question? CONSIDER: Was the study designed to assess the outcomes of an intervention? Is the research question \u2018focused\u2019 in terms of: \u2022 Population studied \u2022 Intervention given \u2022 Comparator chosen \u2022 Outcomes measured?<\/p>\n
Yes No Can\u2019t tell o o<\/p>\n
2. Was the assignment of participants to interventions randomised? CONSIDER: \u2022 How was randomisation carried out? Was<\/p>\n
the method appropriate? \u2022 Was randomisation sufficient to eliminate<\/p>\n
systematic bias? \u2022 Was the allocation sequence concealed<\/p>\n
from investigators and participants?<\/p>\n
Yes No Can\u2019t tell o o o<\/p>\n
3. Were all participants who entered the study accounted for at its conclusion? CONSIDER: \u2022 Were losses to follow-up and exclusions<\/p>\n
after randomisation accounted for? \u2022 Were participants analysed in the study<\/p>\n
groups to which they were randomised (intention-to-treat analysis)?<\/p>\n
\u2022 Was the study stopped early? If so, what was the reason?<\/p>\n
Yes No Can\u2019t tell o o o<\/p>\n
Section B: Was the study methodologically sound?<\/p>\n
4. \u2022 Were the participants \u2018blind\u2019 to<\/p>\n
intervention they were given? \u2022 Were the investigators \u2018blind\u2019 to the<\/p>\n
intervention they were giving to participants?<\/p>\n
\u2022 Were the people assessing\/analysing outcome\/s \u2018blinded\u2019?<\/p>\n
Yes No Can\u2019t tell<\/p>\n
o o o o o<\/p>\n
o o o<\/p>\n
5. Were the study groups similar at the start of the randomised controlled trial? CONSIDER: \u2022 Were the baseline characteristics of each<\/p>\n
study group (e.g. age, sex, socio-economic group) clearly set out?<\/p>\n
\u2022 Were there any differences between the study groups that could affect the outcome\/s?<\/p>\n
Yes No Can\u2019t tell o o o<\/p>\n
3<\/p>\n
6. Apart from the experimental intervention, did each study group receive the same level of care (that is, were they treated equally)?<\/p>\n
CONSIDER: \u2022 Was there a clearly defined study protocol? \u2022 If any additional interventions were given<\/p>\n
(e.g. tests or treatments), were they similar between the study groups?<\/p>\n
\u2022 Were the follow-up intervals the same for each study group?<\/p>\n
Yes No Can\u2019t tell o o o<\/p>\n
Section C: What are the results?<\/p>\n
7. Were the effects of intervention reported comprehensively?<\/p>\n
CONSIDER:<\/p>\n
\u2022 \u2022 What outcomes were measured, and were<\/p>\n
they clearly specified? \u2022 How were the results expressed? For<\/p>\n
binary outcomes, were relative and absolute effects reported?<\/p>\n
\u2022 Were the results reported for each outcome in each study group at each follow-up interval?<\/p>\n
\u2022 Was there any missing or incomplete data? \u2022 Was there differential drop-out between the<\/p>\n
study groups that could affect the results? \u2022 Were potential sources of bias identified? \u2022 Which statistical tests were used? \u2022 Were p values reported?<\/p>\n
Yes No Can\u2019t tell o o o<\/p>\n
8. Was the precision of the estimate of the intervention or treatment effect reported?<\/p>\n
CONSIDER: \u2022 Were confidence intervals (CIs) reported?<\/p>\n
Yes No Can\u2019t tell o o o<\/p>\n
9. Do the benefits of the experimental intervention outweigh the harms and costs?<\/p>\n
CONSIDER: \u2022 What was the size of the intervention or<\/p>\n
treatment effect? \u2022 Were harms or unintended effects<\/p>\n
reported for each study group? \u2022 Was a cost-effectiveness analysis<\/p>\n
undertaken? (Cost-effectiveness analysis allows a comparison to be made between different interventions used in the care of the same condition or problem.)<\/p>\n
Yes No Can\u2019t tell o o o<\/p>\n
Was a power calculation undertaken?<\/p>\n
4<\/p>\n
Section D: Will the results help locally?<\/p>\n
10. Can the results be applied to your local population\/in your context?<\/p>\n
CONSIDER: \u2022 Are the study participants similar to the<\/p>\n
people in your care? \u2022 Would any differences between your<\/p>\n
population and the study participants alter the outcomes reported in the study?<\/p>\n
\u2022 Are the outcomes important to your population?<\/p>\n
\u2022 Are there any outcomes you would have wanted information on that have not been studied or reported?<\/p>\n
\u2022 Are there any limitations of the study that would affect your decision?<\/p>\n
Yes No Can\u2019t tell o o o<\/p>\n
11. Would the experimental intervention provide greater value to the people in your care than any of the existing interventions?<\/p>\n
CONSIDER: \u2022 What resources are needed to introduce<\/p>\n
this intervention taking into account time, finances, and skills development or training needs?<\/p>\n
\u2022 Are you able to disinvest resources in one or more existing interventions in order to be able to re-invest in the new intervention?<\/p>\n
Yes No Can\u2019t tell o o o<\/p>\n
APPRAISAL SUMMARY: Record key points from your critical appraisal in this box. What is your conclusion about the paper? Would you use it to change your practice or to recommend changes to care\/interventions used by your organisation? Could you judiciously implement this intervention without delay?<\/p>\n
Study and citation:
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\nAPPRAISAL SUMMARY:<\/p>\n
—-<\/p>\n
Standard Checklist for CASP Randomised Controlled Trials: 11 questions to help you understand a randomised controlled trial (RCT)<\/p>\n
The following are the main points to consider: When evaluating a randomized controlled experiment, several factors must be taken into account:<\/p>\n
Is a randomized controlled trial’s basic research design valid? (A Section)<\/p>\n
Was the study conducted in a methodologically sound manner? (Section B) If you’re looking for a unique way to express yourself What are the outcomes? (Chapter C) Will the outcomes be beneficial to the community? (Chapter D)<\/p>\n
The checklist’s 11 questions are meant to help you think about these issues in a systematic way.<\/p>\n
How to utilize this tool for Assessment: The first three questions (Section A) are quick-to-answer screening questions about the validity of the basic study design. If you believe the study is valid based on your replies to Section A,<\/p>\n","protected":false},"excerpt":{"rendered":"
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