Reporting checklist (CARE, STROBE, CONSORT, PRISMA)
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CARE 2013
Case reports · Official statement · EQUATOR
| Done | Item | Section | What to report | Page / line in your manuscript |
|---|---|---|---|---|
| 1 | Title | The words "case report" plus the area of focus | ||
| 2 | Key words | Two to five key words, including "case report" | ||
| 3a | Abstract | Introduction: what is unique about this case and what does it add to the medical literature? | ||
| 3b | Abstract | The main symptoms and/or the important clinical findings | ||
| 3c | Abstract | The main diagnoses, therapeutic interventions and outcomes | ||
| 3d | Abstract | Conclusion: the main "take-away" lessons from this case | ||
| 4 | Introduction | A one- or two-paragraph summary of why the case is unique, with references | ||
| 5a | Patient information | De-identified demographic information and other patient information | ||
| 5b | Patient information | The main concerns and symptoms of the patient | ||
| 5c | Patient information | Medical, family and psychosocial history, including diet, lifestyle and genetic information when relevant, and relevant past interventions with outcomes | ||
| 6 | Clinical findings | Relevant physical examination and other clinical findings | ||
| 7 | Timeline | Important dates and times of the episode of care, as a table or figure | ||
| 8a | Diagnostic assessment | Diagnostic methods (physical examination, laboratory testing, imaging, surveys) | ||
| 8b | Diagnostic assessment | Diagnostic challenges (such as access, financial or cultural) | ||
| 8c | Diagnostic assessment | Diagnostic reasoning, including other diagnoses considered | ||
| 8d | Diagnostic assessment | Prognostic characteristics (such as staging) where applicable | ||
| 9a | Therapeutic intervention | Types of intervention (pharmacologic, surgical, preventive, self-care) | ||
| 9b | Therapeutic intervention | Administration of the intervention (dosage, strength, duration) | ||
| 9c | Therapeutic intervention | Changes in the intervention, with rationale | ||
| 10a | Follow-up and outcomes | Clinician- and patient-assessed outcomes | ||
| 10b | Follow-up and outcomes | Important follow-up diagnostic and other test results | ||
| 10c | Follow-up and outcomes | Intervention adherence and tolerability, and adverse or unanticipated events | ||
| 11 | Discussion | Strengths and limitations of the approach; the relevant medical literature; the rationale for the conclusions; the main take-away lessons | ||
| 12 | Patient perspective | The patient's perspective on the treatments they received, when appropriate | ||
| 13 | Informed consent | The patient gave informed consent for publication when appropriate |
STROBE
Observational studies (cohort, case-control, cross-sectional) · Official statement · EQUATOR
| Done | Item | Section | What to report | Page / line in your manuscript |
|---|---|---|---|---|
| 1a | Title and abstract | The study design is named in the title or the abstract | ||
| 1b | Title and abstract | The abstract gives an informative and balanced summary of what was done and found | ||
| 2 | Background | The scientific background and rationale | ||
| 3 | Objectives | Specific objectives, including any pre-specified hypotheses | ||
| 4 | Study design | Key elements of the design, presented early | ||
| 5 | Setting | Setting, locations and relevant dates (recruitment, exposure, follow-up, data collection) | ||
| 6 | Participants | Eligibility criteria and the sources and methods of selection; for cohort studies the follow-up; for case-control studies the selection of cases and controls; for cross-sectional studies the sampling | ||
| 7 | Variables | All outcomes, exposures, predictors, potential confounders and effect modifiers, with diagnostic criteria where applicable | ||
| 8 | Data sources and measurement | For each variable, the sources of data and the methods of assessment; comparability of the methods between groups | ||
| 9 | Bias | Efforts to address potential sources of bias | ||
| 10 | Study size | How the study size was arrived at | ||
| 11 | Quantitative variables | How quantitative variables were handled in the analyses, and which groupings were chosen and why | ||
| 12 | Statistical methods | All statistical methods, including those for confounding; subgroups and interactions; missing data; loss to follow-up or matching; sensitivity analyses | ||
| 13 | Participants | Numbers at each stage of the study, reasons for non-participation, and a flow diagram if useful | ||
| 14 | Descriptive data | Characteristics of participants, information on exposures and confounders, missing data, and follow-up time | ||
| 15 | Outcome data | Numbers of outcome events or summary measures | ||
| 16 | Main results | Unadjusted and confounder-adjusted estimates with their precision; category boundaries; absolute risk for a meaningful period | ||
| 17 | Other analyses | Analyses of subgroups and interactions, and sensitivity analyses | ||
| 18 | Key results | Key results summarised with reference to the study objectives | ||
| 19 | Limitations | Limitations, including sources of potential bias or imprecision, and their direction and magnitude | ||
| 20 | Interpretation | A cautious overall interpretation considering objectives, limitations, multiplicity, similar studies and other evidence | ||
| 21 | Generalisability | The external validity of the results | ||
| 22 | Funding | Source of funding and the role of the funders |
CONSORT 2010
Randomised trials · Official statement · EQUATOR
| Done | Item | Section | What to report | Page / line in your manuscript |
|---|---|---|---|---|
| 1a | Title and abstract | Identification as a randomised trial in the title | ||
| 1b | Title and abstract | Structured summary of trial design, methods, results and conclusions | ||
| 2a | Introduction | Scientific background and explanation of rationale | ||
| 2b | Introduction | Specific objectives or hypotheses | ||
| 3a | Trial design | Description of the trial design (such as parallel, factorial), including the allocation ratio | ||
| 3b | Trial design | Important changes to the methods after the trial started, with reasons | ||
| 4a | Participants | Eligibility criteria for participants | ||
| 4b | Participants | Settings and locations where the data were collected | ||
| 5 | Interventions | The interventions for each group with enough detail to allow replication, including how and when they were given | ||
| 6a | Outcomes | Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | ||
| 6b | Outcomes | Any changes to trial outcomes after the trial started, with reasons | ||
| 7a | Sample size | How the sample size was determined | ||
| 7b | Sample size | When applicable, explanation of any interim analyses and stopping guidelines | ||
| 8a | Randomisation: sequence generation | Method used to generate the random allocation sequence | ||
| 8b | Randomisation: sequence generation | Type of randomisation; details of any restriction (such as blocking and block size) | ||
| 9 | Randomisation: allocation concealment | Mechanism used to implement the allocation sequence, describing the steps taken to conceal it until interventions were assigned | ||
| 10 | Randomisation: implementation | Who generated the allocation sequence, who enrolled participants, and who assigned participants to interventions | ||
| 11a | Blinding | If done, who was blinded after assignment to interventions and how | ||
| 11b | Blinding | If relevant, the similarity of the interventions | ||
| 12a | Statistical methods | Statistical methods used to compare groups for primary and secondary outcomes | ||
| 12b | Statistical methods | Methods for additional analyses, such as subgroup analyses and adjusted analyses | ||
| 13a | Participant flow | For each group, the numbers randomly assigned, receiving the intended treatment, and analysed for the primary outcome | ||
| 13b | Participant flow | For each group, losses and exclusions after randomisation, with reasons | ||
| 14a | Recruitment | Dates defining the periods of recruitment and follow-up | ||
| 14b | Recruitment | Why the trial ended or was stopped | ||
| 15 | Baseline data | A table showing baseline demographic and clinical characteristics for each group | ||
| 16 | Numbers analysed | For each group, the number of participants included in each analysis and whether the analysis was by the original assigned groups | ||
| 17a | Outcomes and estimation | For each primary and secondary outcome, the results for each group, the estimated effect size and its precision (such as a 95% confidence interval) | ||
| 17b | Outcomes and estimation | For binary outcomes, presentation of both absolute and relative effect sizes is recommended | ||
| 18 | Ancillary analyses | Results of any other analyses performed, distinguishing pre-specified from exploratory | ||
| 19 | Harms | All important harms or unintended effects in each group | ||
| 20 | Limitations | Trial limitations, addressing sources of potential bias, imprecision and, if relevant, multiplicity of analyses | ||
| 21 | Generalisability | Generalisability (external validity, applicability) of the trial findings | ||
| 22 | Interpretation | Interpretation consistent with the results, balancing benefits and harms, and considering other relevant evidence | ||
| 23 | Registration | Registration number and name of the trial registry | ||
| 24 | Protocol | Where the full trial protocol can be accessed, if available | ||
| 25 | Funding | Sources of funding and other support (such as supply of drugs), and the role of the funders |
PRISMA 2020
Systematic reviews and meta-analyses · Official statement · EQUATOR
| Done | Item | Section | What to report | Page / line in your manuscript |
|---|---|---|---|---|
| 1 | Title | Identify the report as a systematic review | ||
| 2 | Abstract | See the PRISMA 2020 for Abstracts checklist | ||
| 3 | Introduction | Describe the rationale for the review in the context of existing knowledge | ||
| 4 | Introduction | Provide an explicit statement of the objective(s) or question(s) the review addresses | ||
| 5 | Eligibility criteria | Specify the inclusion and exclusion criteria and how studies were grouped for the syntheses | ||
| 6 | Information sources | Specify all databases, registers, websites and other sources searched, and the date each was last searched | ||
| 7 | Search strategy | Present the full search strategies for all databases, registers and websites, including filters and limits | ||
| 8 | Selection process | Specify the methods used to decide whether a study met the inclusion criteria, including how many reviewers screened and whether they worked independently | ||
| 9 | Data collection process | Specify the methods used to collect data from reports, including how many reviewers and any processes for confirming data | ||
| 10a | Data items | List and define all outcomes for which data were sought | ||
| 10b | Data items | List and define all other variables for which data were sought, and any assumptions about missing information | ||
| 11 | Risk of bias assessment | Specify the methods used to assess risk of bias in the included studies, including the tool(s) and how many reviewers | ||
| 12 | Effect measures | Specify for each outcome the effect measure(s) used in the synthesis or presentation of results | ||
| 13a | Synthesis methods | Describe the processes used to decide which studies were eligible for each synthesis | ||
| 13b | Synthesis methods | Describe any methods required to prepare the data for presentation or synthesis | ||
| 13c | Synthesis methods | Describe any methods used to tabulate or visually display results of individual studies and syntheses | ||
| 13d | Synthesis methods | Describe any methods used to synthesise results and provide a rationale for the choice(s); if a meta-analysis was done, describe the model(s), method(s) to identify heterogeneity and software | ||
| 13e | Synthesis methods | Describe any methods used to explore possible causes of heterogeneity among study results | ||
| 13f | Synthesis methods | Describe any sensitivity analyses conducted to assess the robustness of the synthesised results | ||
| 14 | Reporting bias assessment | Describe any methods used to assess risk of bias due to missing results in a synthesis | ||
| 15 | Certainty assessment | Describe any methods used to assess certainty (confidence) in the body of evidence for an outcome | ||
| 16a | Study selection | Describe the results of the search and selection process, ideally with a flow diagram | ||
| 16b | Study selection | Cite studies that might appear to meet the inclusion criteria but were excluded, and explain why | ||
| 17 | Study characteristics | Cite each included study and present its characteristics | ||
| 18 | Risk of bias in studies | Present assessments of risk of bias for each included study | ||
| 19 | Results of individual studies | For all outcomes, present for each study summary statistics for each group and an effect estimate with its precision, ideally using structured tables or plots | ||
| 20a | Results of syntheses | For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies | ||
| 20b | Results of syntheses | Present results of all statistical syntheses conducted; if meta-analysis was done, present for each the summary estimate and its precision, and the heterogeneity statistics | ||
| 20c | Results of syntheses | Present results of all investigations of possible causes of heterogeneity among study results | ||
| 20d | Results of syntheses | Present results of all sensitivity analyses conducted | ||
| 21 | Reporting biases | Present assessments of risk of bias due to missing results for each synthesis assessed | ||
| 22 | Certainty of evidence | Present assessments of certainty (confidence) in the body of evidence for each outcome assessed | ||
| 23a | Discussion | Provide a general interpretation of the results in the context of other evidence | ||
| 23b | Discussion | Discuss any limitations of the evidence included in the review | ||
| 23c | Discussion | Discuss any limitations of the review processes used | ||
| 23d | Discussion | Discuss implications of the results for practice, policy and future research | ||
| 24a | Registration and protocol | Provide registration information for the review, including the register name and registration number, or state that the review was not registered | ||
| 24b | Registration and protocol | Indicate where the review protocol can be accessed, or state that a protocol was not prepared | ||
| 24c | Registration and protocol | Describe and explain any amendments to the information provided at registration or in the protocol | ||
| 25 | Support | Describe sources of financial or non-financial support for the review, and the role of the funders or sponsors | ||
| 26 | Competing interests | Declare any competing interests of review authors | ||
| 27 | Availability of data, code and other materials | Report which of the following are publicly available and where: template data collection forms, data extracted from included studies, data used for analyses, analytic code, other materials |
:1 of :2 items ticked
Item
What to report
Page / line in your manuscript
How it works
The item numbers are those of the official statements; the wording is shortened. The official statement is the reference.
Write the page and line where each item is reported. The checklist is not peer review and does not prove that a paper follows the guideline.
These tools support writing; they do not replace the Instructions for Authors or the advice of your co-authors and institution.
Questions
Which checklist is for my study?
CARE for case reports, STROBE for cohort, case-control and cross-sectional studies, CONSORT for randomised trials, PRISMA for systematic reviews and meta-analyses.
How do I get a PDF?
Press the button and choose "Save as PDF" as the printer. Nothing is uploaded; your ticks stay on your device.