Open Access
Review
Table 3.
ROB/quality assessment for case series.
| Ilfeld et al. [31] |
Ilfeld et al. [28] |
Ilfeld et al. [29] |
||||
|---|---|---|---|---|---|---|
| Criteria | Comments | Response | Comments | Response | Comments | Response |
| Were participants a representative sample selected from a relevant patient population (e.g., randomly selected from those seeking treatment despite age, duration of disease, primary of secondary disease and severity of disease)? | Patients undergoing TKA were offered novel analgesic treatment and those that consented to the treatment were included in the report. | Yes | The included participants fit inclusion criteria that well-represents the population of those who require TKA | Yes | All participants were patients previously scheduled for TKA at a single institution | Yes |
| Were the inclusion/exclusion criteria of participants clearly described? | Only statement in manuscript to this point is that patients undergoing TKA were offered the treatment; no statement of how many were offered or if there were limiting criteria | Unclear | Both are very clearly stated in the methods section | Yes | The only stated requirement was that participants must have been previously scheduled to undergo TKA at the authors home institution (University of California, San Diego) | Unclear |
| Were participants entering the study at a similar point in their disease progression (i.e., severity of disease)? | All participants were enrolled preoperatively | Yes | All participants were enrolled preoperatively | Yes | All participants were enrolled preoperatively | Yes |
| Was selection of patients consecutive? | Not stated | N/A | 7 patients were enrolled and completed the study over a 7-month period, it was not stated how many TKA operations were performed by the surgeon over this duration or if all patients were offered enrollment into the study | Unclear | Not stated | N/A |
| Was data collection undertaken prospectively? | All data were collected in the postoperative period | Yes | All data were collected in the postoperative period; the study was prospectively registered | Yes | All data were collected in the postoperative period | Yes |
| Was the intervention (and comparison) clearly defined? | The intervention (ultrasound-guided percutaneous cyroneurolysis) was very clearly described and it was stated that the subjects were compared to historical controls (references for control studies listed) | Yes | The experimental intervention (percutaneous peripheral nerve stimulation) was clearly described; because of the small case series design of the study, no control group was used for comparison | Yes | The intervention (percutaneous peripheral nerve stimulation) was clearly described; participants were subjectively compared to historical controls because of the case series design | Yes |
| Was the intervention undertaken by someone experienced at performing the procedure? | It was not stated who performed the procedure | N/A | The performing surgeon was stated in the author contributions portion, and it was stated that the device used was FDA approved, but the surgeon’s experience is not stated | N/A | It is not stated who performed the procedure | N/A |
| Were the staff, place, and facilities where the patients were treated appropriate for performing the procedure (e.g., access to back-up facilities in hospital or special clinic)? | Procedures were performed at the University of California, San Diego hospital | Yes | Procedures were performed at the University of California, San Diego hospital | Yes | Procedures were performed at the University of California, San Diego hospital | Yes |
| Were objective (valid and reliable) outcome measures used, including satisfaction scale? | Pain scores, opioid use, analysis of motor function, and time of return to normal skin sensation were all used as outcome measures | Yes | Pain scores were measured at a multitude of time points through weekly clinic visits or phone calls to participants and daily diary keeping, functional recovery was assessed using the WOMAC index, TUG test and 6MWT | Yes | Pain scores, time to opioid cessation, the 6WMT and the WOMAC index were all used as outcome measures | Yes |
| Was follow-up long enough to detect important effects on outcomes of interest? | Participants were followed up with for at least 4 months postoperatively, seeming to be an adequate time to determine effects of an analgesic used in the perioperative/immediate postoperative period (moreover, all patients were followed until they had returned completely to normal feeling and function) | Yes | Outcomes were assessed through postoperative week 12 and the interventional treatment lasted for a maximum of 42 days (6 weeks), this allowed for adequate follow-up on functional recovery and chronic postoperative pain well after the intervention was completed. | Yes | Outcomes were assessed through postoperative week 12 and the interventional treatment lasted for a maximum of 6 weeks, this allowed adequate follow-up on functional recovery and chronic postoperative pain well after the intervention was completed. | Yes |
| Was information provided on non-respondents, dropouts? | Not stated, unclear if there were no dropouts or if the information was omitted because the study is a case series | No | Not stated, unclear if there were no dropouts or if the information was omitted because the study is a case series | No | Not stated, unclear if there were no dropouts or if the information was omitted because the study is a case series | No |
| Were the characteristics of withdrawals/dropouts similar to those that completed the study and therefore unlikely to cause bias? | N/A | N/A | N/A | |||
| Were the important prognostic factors identified (e.g., age, duration of disease, disease severity)? | Only parameter stated was that all participants were undergoing TKA | Unclear | Exclusion factors for the study encompassed many factors for increased risk of infection and other factors increasing surgical risk | Yes | The only parameters stated for enrollment were that participants be scheduled for TKA at the study site, it was not stated in the manuscript if other factors were collected | Unclear |
| Overall risk-of-bias judgment (High, Low, or Some Concern) | While no specific parts of the study design imply any greater risk-of-bias than all case series, the study is rated as “some concern” because no information was provided on dropouts or detailed enrollment parameters | Some Concern | This study was rated as some concern because the study design and inclusion/exclusion criteria were clear and pre-registered, but no information was provided on consecutive/inconsecutive participant enrollment, and no control group was used | Some Concern | While no specific parts of the study design imply any greater risk-of-bias than all case series, the study is rated as “some concern” because no information was provided on dropouts or detailed enrollment parameters | Some Concern |
*Possible Responses: Yes, No, N/A, unclear.
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