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Table 2 Quality checklist of eight clinical research studies plus one clinically relevant research study on Functional Neurology approach included in a critical review

From: Unravelling functional neurology: a critical review of clinical research articles on the effect or benefit of the functional neurology approach

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.

       
  1. NA: Not applicable
  2. (?): Uncertainty
  3. *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