Table 2.
Quality checklist of eight clinical research studies plus one clinically relevant research study on Functional Neurology approach included in a critical review
| 1st Author Year Journal | All studies included | Clinical research studies with appropriate or potentially appropriate study design to investigate an effect or benefit of Functional Neurology approach | |||||||
|---|---|---|---|---|---|---|---|---|---|
| -Design -Design appropriate to investigate effect or benefit of intervention? |
If design was not appropriate, major methodological considerations (“NA” for appropriate or potentially appropriate study design) | Were study subjects stated to be: -Blind to treatment allocation? (NA if no sham) -Naïve to types of intervention? |
-Was a random allocation reported? -Was it stated that this was concealed? (NA if no random allocation) |
Were interventions well described? | Was the assessor reported to be blind? | Outcome measure reported to be reliable or reproducible? | Was the person who analyzed the data stated to be blind? | Were losses or exclusions reported or obvious in results, tables or graphs? | |
| Malkowicz 2006 [20] Intern J Neuroscience |
Retrospective study of clinical database with external control group (from previously published study) -No |
In order to investigate the effect of intervention, it would be necessary to include a concomitant control group to ensure that the two groups are similar and assessed at similar interval(s). | |||||||
| Daubeny 2010 [21] Int J Disabil Hum Dev |
-Randomized controlled trial -Yes |
NA | -No -No |
-Yes -No |
Yes | Yes | No | No | Yes |
| Leisman 2010a [22] Int J Disabil Hum Dev |
-Two randomized controlled trials (?) -Yes |
NA | -NA -No |
-Yes -No |
Yes | No | No | No | No |
| Leisman 2010b [23] Int J Adolesc Med Health |
-Case series from multiple clinics (?) or Multicenter outcome study (?)* -No |
In order to investigate an effect, a control group would be needed. | |||||||
| Carrick 2011 [16] Funct Neurol Rehabil Ergon |
-Outcome study -No |
In order to investigate an effect or benefit, a control group would be needed. | |||||||
| Castellanos 2012 [24] Funct Neurol Rehabil Ergon |
-Outcome study with healthy untreated control group at baseline -No |
In order to investigate effect or benefit, a similar control group subjected to another intervention would be needed. | |||||||
| Carrick 2013 [17] Funct Neurol Rehabil Ergon |
-Four arms randomized trial (?) -Potentially |
NA | -NA -No |
-Yes -No |
Yes | No | No | No | No |
| Sullivan 2013 [18] Funct Neurol Rehabil Ergon |
-Prospective case series with sham treatment in 3/13 cases -Potentially |
NA | -No -No |
-No -NA |
Yes | No | No | No | Yes |
| Bousquet 2015 [19] Funct Neurol Rehabil Ergon |
-Outcome study -No |
In order to investigate an effect, a control group would be needed. | |||||||
NA: Not applicable
(?): Uncertainty
*Reported as a pilot study by the authors but used for making conclusion about the effect of the FN intervention. Also the fact that this was a multicenter study was not clear