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Table 2.
ROB assessment for randomized controlled trials: Revised Cochrane ROB tool for Randomized Trials.
| He et al. 2013 |
Ilfeld et al. 2019 |
|||
|---|---|---|---|---|
| Signaling Question | Comments | Response | Comments | Response |
| Domain 1: Risk of bias arising from the randomization process | ||||
| 1.1 Was the allocation sequence random? | Random assignment with sealed envelope technique; sham controlled | Y | Randomized to treatment or sham treatment group using computer-generated lists and opaque envelopes. | Y |
| 1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions? | Sealed envelope technique used was utilized. The author specifically states that allocation remained concealed until after the data was analyzed | Y | Opaque envelopes were used. | Y |
| 1.3 Did baseline differences between intervention groups suggest a problem with the randomization process? | No significant difference in baseline clinical tests, age or body weight between groups. Strict inclusion and exclusion criteria were utilized during the patient enrollment process. | N | Groups do not appear largely different in any way based on the demographic data provided; yet, no statistical analysis was run due to the small sample size of the present feasibility study, so it cannot be said with certainty that there are no statistically significant differences | PN |
| Risk-of-bias judgement: Domain 1 | Low risk | Low risk | ||
| Domain 2: Risk of bias due to deviations from the intended intervention (effect of assignment to intervention) | ||||
| 2.1. Were participants aware of their assigned intervention during the trial? | The study was sham-controlled, and there is no mention of participants having knowledge of their intervention group. However, the treatment was self-administered, so it is impossible to say with certainty that all participants were unaware they were performing a sham technique. | PN | The author specifically stated that participants were masked to their intervention throughout the trial. | N |
| 2.2. Were carers and people delivering the interventions aware of participants assigned intervention during the trial? | The surgeons and experimenters were unaware of participants’ assigned interventions, but an acupuncturist had to train each participant to self-administer acupressure to either real or sham auricular acupressure points. The acupuncturist had no contact with the participants after training, and randomization was complete. | N | All experimenters and providers were masked to the participants intervention during the entirety of the trial. | N |
| 2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context? | – | – | ||
| 2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome? | – | – | ||
| 2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups? | – | – | ||
| 2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention? | The sham and experimental groups were statistically compared after randomization for sex, age, bodyweight, American Society of Anesthesiologists (ASA) status, and through Kellgren-Lawrence radiographic grading. | Y | Data was collected on participant demographics, health status, and success of lead implantation. | PY |
| 2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyze participants in the group to which they were randomized? | – | – | ||
| Risk-of-bias judgement: Domain 2 | Low risk | Low risk | ||
| Domain 3: Missing outcome data | ||||
| 3.1 Were data for this outcome available for all, or nearly all, participants randomized? | All 90 randomized patients completed the trial with eligible data. | Y | All 10 randomized patients completed the trial with eligible data. That said, 3 participants required or requested treatment slightly deviating from the original trial protocol. All discrepancies were clearly reported by the author. | PY |
| 3.2 If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data? | – | – | ||
| 3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value? | – | – | ||
| 3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value? | – | – | ||
| Risk-of-bias judgement: Domain 3 | Low risk | Low risk | ||
| Domain 4: Risk of bias in measurement of the outcome | ||||
| 4.1 Was the method of measuring the outcome inappropriate? | Outcomes were measured thoroughly and through multiple measures. Pain intensity scores (VAS scores), used dose and total dose of analgesic via PCA, incidence of adverse effects due to analgesic treatments, Hospital for Special Surgery (HSS) scores and range of motion measures were all used as an evaluation of the experimental non-pharmacologic analgesic treatment. | N | Multiple viable outcome measures were used to assess the efficacy of the presented percutaneous peripheral nerve stimulator as a non-pharmacologic analgesic. Pain level, opioid consumption, perceived sensory deficit, and whether or not the participant had used the perineural infusion analgesic were all recorded at multiple time points. | N |
| 4.2 Could measurement or ascertainment of the outcome have differed between intervention groups? | All measures used were standardized and the sham-control group went through all of the same procedures as the experimental group. | N | All measures were standardized and experimenters, carers, and participant’s were all blinded to each participants intervention. Further, the sham group went through exactly the same procedure and measurements as the experimental group. | N |
| 4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants? | Participant intervention method remained blinded to the assessors until after all data was analyzed. | N | Participant intervention method remained double blinded until after data collection. | N |
| 4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received? | – | – | ||
| 4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received? | – | – | ||
| Risk-of-bias judgement: Domain 4 | Low risk | Low risk | ||
| Domain 5: Risk of bias in selection of the reported results | ||||
| 5.1 Were the data that produced this result analyzed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? | Number of participants needed for sufficient statistical power, dropout rates, and measures were discussed as if they were predetermined in the manuscript, but no protocol found. | PY | No statistical analysis was run because of the small sample size associated with it being a feasibility study. | NI |
| 5.2 Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g., scales, definitions, time points) within the outcome domain? | All outcome measures listed and tested were fully reported in the text and/or figures. | N | All outcome measures listed and tested were fully reported in the text and/or figures. | N |
| 5.3 Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data? | All listed measures in the methods are reported on and all data was analyzed before the researchers were unblinded to participants intervention type. The rating remains PN, however, as no statistical plan is listed or cited outside of the article itself. | PN | As no statistical analysis was run, it would not have been possible for the author to leave out certain representations of the statistical results. | N |
| Risk-of-bias judgement: Domain 5 | Low risk | Rated as “some concern” because of NI response to 5.1. | Some Concern | |
| Overall Risk of Bias | ||||
| Risk-of-bias judgement: All | Low risk | All but 1 domain is rated as low risk, but in accordance with the Cochrane risk-of-bias tool, the overall risk-of-bias is some concern. | Some Concern | |
*Possible responses to domain questions: Yes (Y), Probably Yes (PY), No (N), Probably No (PN), No Information (NI).
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