Medical Sciences
STUDY BACKGROUND
Title & Citation • Correctly list the title and full citation of the study
Affiliation and funding • List author’s affiliation and any source of funding disclosed
• Evaluate the potential impact of any affiliation(s) and/or funding on the quality of the study
General Background
• Provide a general background of the study topic including epidemiology, disease state, and intervention(s) used in the study
• Identify limitation of knowledge or problems with current treatment strategies which lead the investigators to conduct the study
Previous Trials
• Listtitle and citation of any relevant previous trials applicable to the study
• Provide key details such as patient population, study design, interventions, endpoints, outcomes, and conclusion of the studies
Study rationale • Explain why the study was conducted and its potential contribution to clinical practice
STUDY OVERVIEW
Objective(s) • Explain the objective(s) of the study and/or specific research question being addressed
Hypothesis • Clearly state and evaluate the hypothesis in relation to the research question or objective(s) being examined
Study design
• Describe and explain the study design and/or study type
METHODS( list pertinent information ONLY, refer to paper for details)
Sample size • Describe how patients were randomized and enrolled
• Include sample size
Inclusion criteria
• List the inclusion criteria for the study
Exclusion criteria
• List the exclusion criteria for the study
Investigator controls • Identify and describeany investigator controls used in the study i.e. blinding, randomization etc.
Interventions
• Provide a detailed description of treatments and/or interventions used
• Elaborate on the treatment arms used
• Include key details such as dose, timing of administration, frequency, duration of treatment etc.
Measurements • Describe how patients were monitored and followed
• Describe how data were collected
Primary endpoints
• Describe in details primary endpoint(s) being measured and its relation to the study objective(s)
Secondary endpoints
• Describe in details secondary endpoint(s) being measured and its relation to the study objective(s)
Statistical analyses • List and explain statistical methods used
RESULTS
Patient enrollment
• Include sample size, study power, description of groups
• Evaluate and explain if patients enrolled are true representation of population
Baseline characteristics
• Review baseline characteristics
• Explain any tables or figures which refer to baseline characteristics
Monitoring
• Provide key points about patient monitoring process and/or data collection
• Include details of how issues in data collection or monitoring, if any were addressed
Primary endpoint(s)
• Describe the results of the primary endpoint(s)
• Include all statistical data presented (p-value, confidence interval etc.)
• Provide all necessary data and refer to all figures, tables and/or graphs
Secondary endpoint(s)
• Describe the results of the secondary endpoint(s)
• Include all statistical data presented (p-value, confidence interval etc.)
• Provide all necessary data and refer to all figures, tables and/or graphs
Other clinical significant events
• Describe any other clinically significant events that occurred which the investigators were not planning on measuring
• Provide all necessary data provided and refer to all figures, tables and/or graphs
AUTHOR’S CONCLUSION
• Provide key findings and complete description of author’s conclusion
• Explain how the results relate to the study objective and/or research question
DISCUSSION & CRITIQUE
Patient population
• Review baseline characteristics for any statistical or clinically significant differences
• Determine if the patients enrolled are a true representation of population
• Evaluate inclusion and exclusion criteria for appropriateness
Interventions
• Evaluate intervention or medication therapies being tested for appropriateness
• Determine if the intervention being tested is representation of either current practice or obtained from previously well conducted studies
• Determine if the interventions represent standard of care
Endpoints • Determine if the endpoints are relevant and significant
• Determine if the endpoints represent the desired outcome of the intervention
• Evaluate the clinical relevance of the endpoints being measured
Statistics
• Determine if the statistical tests used in the study are appropriate
• Assess the type of data used
• Determine if the study is appropriately powered including the NNT
• Determine if the study is subject to Type I or Type II errors
LEADER’S CONCLUSION
• Provide your conclusion of the study
• Effectively communicate the value of the study findings to clinical practice while taking into consideration study limitations, biases, strengths, and weaknesses etc.
References: (Provide minimum 2-3 primary references used in AMA style referencing)
http://writerslabs.com/file?alias=Article_4.pdf&file=795845217_support_Article_4_n2tgrY0f1TXUbAX.pdf