Table 1.
Methodological Rigor Scoring
| Articles are scored with a methodology score from EITHER Part A or Part B | |
| A. Quantitative scoring | |
| 1. Aims/outcome (observational and experimental) | |
| a. Defined at outset | 2 |
| b. Implied in paper | 1 |
| c. Unclear | 0 |
| 2. Sample formation (observational and experimental) | |
| a. Random | 2 |
| b. Quasi-random; sequential series in given setting or total available | 1 |
| c. Selected, historical, other, insufficient information | 0 |
| 3. Inclusion/exclusion criteria (observational and experimental) | |
| a. Explicitly described | 2 |
| b. Implied by patient characteristics, setting | 1 |
| c. Unclear | 0 |
| 4. Subjects described (observational and experimental) | |
| a. Full information | 2 |
| b. Partial information | 1 |
| c. No information | 0 |
| 5. Power of study calculated (observational and experimental) | |
| a. Yes | 2 |
| b. No | 0 |
| 6. Outcome measures (observational and experimental) | |
| a. Objective | 2 |
| b. Subjective | 1 |
| c. Not explicit | 0 |
| 7. Follow-up (observational and experimental) | |
| a. > 80% of subjects available for follow-up | 2 |
| b. 70–80% of subjects available for follow-up | 1 |
| c. < 70% of subjects available for follow-up | 0 |
| 8. Analysis (observational and experimental) | |
| a. Intention to treat/including all available data | 2 |
| b. Excluding drop-outs but evidence of bias adjusted or no bias evident | 1 |
| c. Excluding drop-outs and no attention to bias or imputing results | 0 |
| 9. Baseline differences between groups (experimental only) | |
| a. None or adjusted | 2 |
| b. Differences unadjusted | 1 |
| c. No information | 0 |
| d. Cohort/descriptive study only/not applicable | 0 |
| 10. Unit of allocation to intervention (experimental only) | |
| a. Appropriate | 2 |
| b. Nearly | 1 |
| c. Inappropriate or no control group | 0 |
| d. Cohort/descriptive study only/not applicable | 0 |
| 11. Randomization/method of allocation of subjects (experimental only) | |
| a. Random | 2 |
| b. Method not explicit | 1 |
| c. Before exclusion of drop-outs or nonrandomized | 0 |
| d. Cohort/descriptive study only/not applicable | 0 |
| Total score (possible 22) | |
| B. Qualitative scoring | |
| 1. Is there a clear connection to an existing body of knowledge/Theoretical framework? | |
| a. Yes | 1 |
| b. No | 0 |
| 2. Are research methods appropriate to the question being asked? | |
| a. Yes | 1 |
| b. No | 0 |
| 3. Is the description of the context for the study clear and sufficiently detailed? | |
| a. Yes | 1 |
| b. No | 0 |
| 4. Is the description of the method clear and sufficiently detailed to be replicated? | |
| a. Yes | 1 |
| b. No | 0 |
| 5. Is there an adequate description of the sampling strategy? | |
| a. Yes | 1 |
| b. No | 0 |
| 6. Is the method of data analysis appropriate and justified? | |
| a. Yes | 1 |
| b. No | 0 |
| 7. Are procedures for data analysis clearly described and in sufficient detail? | |
| a. Yes | 1 |
| b. No | 0 |
| 8. Is there evidence that the data analysis involved more than one researcher? | |
| a. Yes | 1 |
| b. No | 0 |
| 9. Are the participants adequately described? | |
| a. Yes | 1 |
| b. No | 0 |
| 10. Are the findings presented in an accessible and easy-to-follow manner? | |
| a. Yes | 1 |
| b. No | 0 |
| 11. Is sufficient original evidence provided to support the relationship between interpretation and evidence? | |
| a. Yes | 1 |
| b. No | 0 |
| Total score (possible 11) | |