External Validity |
1. Was the study's target population representative of most TKR populations on relevant demographic and clinical variables, e.g. age, sex, pain severity, osteoarthritis grade?* |
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The target population refers to the group of patients to which the results of the study will be generalised. Examples:
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The study was a survey of patients in a hospital department and the sample was drawn from a list that included all individuals operated on over a two-year period. The answer is: Yes (LOW RISK).
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The study was conducted in one province only, and it is not clear if this was representative of the national population. The answer is: No (HIGH RISK).
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The study was undertaken asking responses from people considering revision surgery and it is clear this was not representative of most TKR populations. The answer is: No (HIGH RISK).
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2. Was the sampling frame a true or close representation of the TKR population?* |
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The sampling frame is a list of the sampling units in the target population and the study sample is drawn from this list. Examples:
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The sampling frame was a database of every individual who received a TKR within a hospital. The answer is: Yes (LOW RISK).
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The study asked responses from anonymous people in an online chat group. The answer is: Yes (LOW RISK).
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3. Was some form of consecutive or random selection used to select the sample? |
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Yes (LOW RISK): Some form of consecutive or random selection was used to select the sample (e.g. simple random sampling, stratified random sampling, cluster sampling, systematic sampling).
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No (HIGH RISK): Some form of consecutive or random selection was NOT used to select the sample.
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In a survey, only part of the sampling frame is sampled. In these instances, consecutive or random selection of the sample helps minimise study bias. Examples:
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Every person in a consecutive sample was surveyed. The answer is: Yes (LOW RISK).
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The sample was selected using simple random sampling. The answer is: Yes (LOW RISK).
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A clinician asked a non-consecutive sample of his/her patients. The answer is: No (HIGH RISK).
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4. Was the likelihood of non-response bias minimal?* |
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Yes (LOW RISK): The response rate for the study was ≥75%, OR, an analysis was performed that showed no significant difference in relevant demographic and clinical characteristics between responders and nonresponders
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No (HIGH RISK): The response rate was <75%, and if any analysis comparing responders and non-responders was done, it showed a significant difference in relevant demographic and clinical characteristics between responders and non-responders.
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Examples:
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The response rate was 68%; however, the researchers did an analysis and found no significant difference between responders and non-responders in terms of age, sex and clinician status. The answer is: Yes (LOW RISK).
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The response rate was 65% and the researchers did NOT carry out an analysis to compare relevant characteristics between responders and non-responders. The answer is: No (HIGH RISK).
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The response rate was 69% and the researchers did an analysis and found a significant difference in age, sex and clinical status between responders and non-responders. The answer is: No (HIGH RISK).
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Internal Validity |
5. Were data collected* directly from the participants (as opposed to a proxy)? |
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Yes (LOW RISK): All data were collected directly from the participants.
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No (HIGH RISK): In some instances, data were collected from a proxy.
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A proxy is a representative of the subject. Examples:
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All eligible participants were surveyed directly.
The answer is: Yes (LOW RISK).
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A clinician, or series of clinicians, estimated how satisfied their patients were.
The answer is: No (HIGH RISK).
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6. Was an acceptable participant definition TKR used in the study?* |
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In a study, the following participant definition was used: “All participants must have had a TKR, which is a surgical procedure to replace the weight-bearing surfaces of the knee joint to relieve pain and disability.” The answer is: Yes (LOW RISK).
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7. Was the study instrument that measured satisfaction shown to have reliability and validity (if necessary)? |
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Yes (LOW RISK): The study instrument had been shown to have reliability and validity, e.g. test-retest, piloting, validation in a previous study, etc.
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No (HIGH RISK): The study instrument had NOT been shown to have reliability or validity
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The authors used a questionnaire, which had previously been validated. They also tested the inter-rater reliability of the questionnaire. The answer is: Yes (LOW RISK).
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The authors developed their own questionnaire and did not test this for validity or reliability. The answer is: No (HIGH RISK).
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8. Was the same mode of data collection used for all participants? |
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The mode of data collection is the method used for collecting information from the subjects. The most common modes are face-to-face interviews, telephone interviews and self-administered questionnaires. Examples:
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All eligible subjects had a face-to-face interview. The answer is: Yes (LOW RISK).
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Some subjects were interviewed over the telephone and some filled in postal questionnaires. The answer is: No (HIGH RISK).
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9. Was the length of the measurement period of satisfaction with TKR appropriate?* |
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The measurement period is the length of time post-surgery. The shorter the measurement period, the greater the likelihood of the participant's satisfaction being about the operative and rehabilitation process rather than about the medium-term or longer-term residual pain and functional capacity. Examples:
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Participants were asked about satisfaction with TKR when they were 12-months post-surgery. The answer is: Yes (LOW RISK).
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Participants were asked about satisfaction when they were 2-months post-surgery. The answer is: No (HIGH RISK).
Note: A follow-up of >6 months was part of the inclusion criteria for this review. Therefore all studies with <6 months were excluded from further consideration in the full text screening.
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10. Were the statistical measures of satisfaction appropriate?* |
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Yes (LOW RISK): The paper presented adequate description of how the summary statistics were calculated, the statistics were appropriate and would be possible to be reproduced in a replication study.
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No (HIGH RISK): The paper did present adequate description of the statistics or one or more of these were inappropriate.
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The individual items in the satisfaction questionnaire were scored and summarised using the method the questionnaire developers validated, and a group mean score was reported with 95% confidence intervals). The answer is: Yes (LOW RISK).
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It is not clear how the measure of satisfaction was scored and/or summarised. The answer is: No (HIGH RISK).
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11. Summary item on the overall risk of study bias |
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LOW RISK OF BIAS: Further research is very unlikely to change our confidence in the estimate.
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MODERATE RISK OF BIAS: Further research is likely to have an important impact on our confidence in the estimate and may change the estimate.
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HIGH RISK OF BIAS: Further research is very likely to have an important impact on our confidence in the estimate and is likely to change the estimate.
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