| Explanation of the Domain | Domain and Item | Score or check | |
|---|---|---|---|
| 1 | 2 | 3 | 4 |
This section is only for CLARITY and not for adequacy, truthfulness, and applicability. This answers WHAT of the study and includes transparency, openness, unambiguity, well defined, and fully identified. |
1 CLARITY How much are you satisfied with the following? (Scores: Full=2, Partial=1, No=0) |
||
| 1.1 | Research question and the objectives have no ambiguity | ||
| 1.2 | Target population is well-defined | ||
| 1.3 | Variables under study (antecedents, intervention, confounders, and outcome) and their definition are clear | ||
| 1.4 | Design of the study (prospective/retrospective/ cross-sectional, allocation, blinding, etc.) and flow of the cases is clearly conceptualized and is transparent | ||
| 1.5 | Method of selection of the study subjects is clear, eligibility clearly specified | ||
| 1.6 | Tools and data elicitation methods (observation, interview, investigation, examination – even for records-based study) are clear | ||
| 1.7 | Data obtained and available for analysis are clear | ||
| 1.8 | Methods of analysis and the road map are clear | ||
| 1.9 | Results expected or obtained are clear | ||
| 1.10 | Conclusions obtained or visualized are clear considering the negative and positive results | ||
| Total score for CLARITY (maximum20) | |||
This section is only for ADEQUACY and not for clarity, truthfulness, and applicability. Adequateincludes comprehensive, complete, enough, ethical, focused, full, justified, measurable, novel, original, plausible, rational, reliable, repeatable, replicable, reproducible, rigorous, significant, sufficient, worthy |
2 ADEQUACY How much are you satisfied with the following? (Scores: Full = 2, Partial = 1, No = 0) |
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| 2.1 | Research question is adequate (original, requires investigation) | ||
| 2.2 | Adequate resources (facilities, expertise) | ||
| 2.3 | Objectives are measurable | ||
| 2.4 | Chosen study variables are adequate to answer the research question and are measurable | ||
| 2.5 | Ethical standards are met | ||
| 2.6 | Sample size for each group is justified for the stated reliability/power | ||
| 2.7 | The study design is adequate (capable of obtaining all the relevant data on antecedents, intervention, confounders, and outcomes on a representative sample), including follow up, if any | ||
| 2.8 | Sufficient data is available after exclusions of missing values, outliers, etc., and exclusions properly accounted | ||
| 2.9 | All the required methods of analysis have been used (no relevant method ignored) – different types of analysis done – the analysis is rigorous with assumptions duly verified | ||
| 2.10 | Reliability of results is adequate (sufficient precision to generate confidence) and the presence of medically significant effect established or denied with reasons | ||
| 2.11 | The plausibility of the results is demonstrated | ||
| 2.12 | The answer to the research question is full and convincing | ||
This section is only for ADEQUACY and not for clarity, truthfulness, and applicability. Adequateincludes comprehensive, complete, enough, ethical, focused, full, justified, measurable, novel, original, plausible, rational, reliable, repeatable, replicable, reproducible, rigorous, significant, sufficient, worthy |
3 TRUTHFULNESS How much are you satisfied with the following? (Scores: Full = 2, Partial = 1, No = 0) |
||
| 3.1 | The title accurately describes the study | ||
| 3.2 | The variables investigated are valid to answer the research question | ||
| 3.3 | The design of the study is right to provide an unbiased answer to the research question (e.g., representative sample of the target population) | ||
| 3.4 | The subjects included are right to provide the correct answer to the research question | ||
| 3.5 | The sample size is correctly calculated for the stated reliability/power, and based on the correct variable or variables | ||
| 3.6 | Data collected and analyzed is factual, unbiased, and error-free | ||
| 3.7 | Cofounders and interaction duly accounted for | ||
| 3.8 | Correct method of analysis used to consider the nature of the data (distribution, inter-dependence, adjustment for confounding, standardized rates, etc.) | ||
| 3.9 | Results really emanate for the data and analysis (not selected to serve a hypothesis, not manipulated), credible results – duly adjusted for missing values | ||
| 3.10 | Different results are internally consistent and internal and external validity of the results demonstrated | ||
| 3.11 | The interpretation of the results is valid in view of confounders, multiple P-values, etc. | ||
| 3.12 | Alternative explanations considered and ruled out | ||
| 3.13 | The conclusion is based on results, limitations, plausibility, corroborative evidence | ||
| Total score for TRUTHFULNESS (maximum 26) | |||
This section is only for ADEQUACY and not for clarity, truthfulness, and applicability. Adequateincludes comprehensive, complete, enough, ethical, focused, full, justified, measurable, novel, original, plausible, rational, reliable, repeatable, replicable, reproducible, rigorous, significant, sufficient, worthy |
4 APPLICABILITY How much are you satisfied with the following? (Scores: Full = 2, Partial = 1, No = 0) |
||
| 4.1 | The research question is relevant, useful, important, and timely | ||
| 4.2 | The setting of the study (clinic/hospital/community) is appropriate for application of the results, the target population is likely to benefit from the results, and inclusion-exclusion criteria are not too restrictive that will hamper the application | ||
| 4.3 | Variables used are such that the data on them can be collected in varying conditions | ||
| 4.4 | Data elicitation methods and tools can be replicated by the others | ||
| 4.5 | Data used for results can be collected in a cost-effective manner | ||
| 4.6 | Analysis methods are understandable by any qualified professional, and replicable | ||
| 4.7 | The results are useful and applicable to the target population and robust/ sustainable under varying conditions – replicability is demonstrated | ||
| 4.8 | Cost and convenience in implementing the results are reasonable and affordable, and the applicability and sustainability of the conclusion is convincing | ||
| 4.9 | The conclusion is medically important to change the current understanding, unaccounted uncertainties considered, and theoretical construct proposed | ||
| 3 | Total score for APPLICABILITY (maximum 18) | ||
This section is for REPORT only comprising statement |
5 REPORTING How much are you satisfied with the following? (Scores:Full = 2, Partial = 1, No = 0) Description of all the previously listed items for which the scores are already assigned in sections 1 to 4 and not to be considered again here |
||
| 5.1 | Simple to understand and accessible to peers and non-specialists | ||
| 5.2 | The draft is concise, focused, and to the point (no unnecessary details) | ||
| 5.3 | Reporting guidelines (CONSORT/ STROBE /STARD and SAMPL) followed | ||
| 5.4 | The presentation is in a logical sequence and coherent, including the use of the tables and graphs | ||
| 5.5 | Confidence but humility in presentation, keeping in view the limitations and medical uncertainties | ||
| Total score for REPORTING (maximum 10) (Reporting of other items of quality already included in the other domains) | |||
| Total score (maximum 100) | |||
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