Table 2.
Reportinbg Quality Item |
---|
1. Are the inclusion and exclusion criteria clearly reported? |
2. Is information regarding the number of patients who did not gave informed consent and who were not willing to participate adequately reported? |
3. Are the baseline characteristics of included patients reported? |
4. Is the surgical technique adequately reported? |
5. Are the prosthesis brand and fixation reported with enough detail? |
6. Are the reasons or definitions for revision adequately reported? |
7. Are the number of revisions (N) and revision rates regarding aseptic loosening (either Kaplan-Meier or life table or revisions per 100 observed component years) adequately reported? |
8. Is the number of deaths, lost-to-follow up (e.g. no show at clinic or emigration), amputations, and revisions other than the primary endpoint adequately reported? |
Methodological Quality Item |
1. Is there a clear primary research question/hypothesis?* |
2. How were the cohorts constructed? |
a. Consecutivelya |
b. Non-consecutively |
c. Unknown |
3. How adequate was the follow-up (FU)? |
a. Fully completed FU |
b. 5% or less lost-to-FU or FU quotientb is 1 or less |
c. More than 5% lost-to-FU or FU quotient is more than 1 |
d. Unknown |
4. How was the FU performed? |
a. Predefined e.g. yearly |
b. When patients had complaints or chart review (of non-predefined FU) |
c. Unknown |
5. How many arthroplasties are at risk at the FU of interest? |
a. 20 or more |
b. Less than 20 |
b. Unknown |
6. Has a worst case analysis or competing risk analysis for competing endpoints [14] been performed? |
* In cases of aseptic loosening: Does the research question or hypothesis include revision of the component due to aseptic loosening?
a Consecutively is defined as all patients receiving an arthroplasty (TKA or THA) in a defined period of time have also received the arthroplasty of interest. The following situation is therefore non-consecutive: patients receiving prosthesis X while prosthesis Y has also been used for the same indication during the specified period.
b FU quotient = Number lost to follow up/Number of failures [26].