Methodologische checklijst: optimale behandeling klompvoet

Methodology checklist – intervention studies (observational) – NOTE: ONLY COMPARATIVE STUDIES ARE GRADED

Research question: what is the optimal treatment for congenital idiopathic clubfoot?

Study reference

 

(first author, year of publication)

Was there a representative and well-defined sample of patients at a similar point in the course of the disease?

 

(yes/no/unclear)

Was follow-up sufficiently long and complete, and similar for all treatments?

 

(yes/no/unclear)

Was the outcome of interest defined and adequately measured? 

 

(yes/no/unclear)

Were the treatments of interest adequately defined?

 

(yes/no/unclear)

Was loss to follow-up / incomplete outcome data described and acceptable? 

 

(yes/no/unclear)

Was there statistical adjustment for all important prognostic factors?

 

 (yes/no/unclear)

Other limitations?

 

(yes/no/unclear)

Ponseti versus PMR

Church et al, 2012

Yes

Yes*1

Yes*2

Yes

Unclear

No

No

Clarke et al, 2011

Yes

No*3

Unclear *2

Yes

Unclear 

No*4

Yes*5

Halanski et al, 2010

Yes

Yes*6

Unclear*2

Yes

Yes

Yes

Yes*6

Ponseti versus Kite

Segev et al,

2005

Yes

No*3

No

Yes

Unclear

No*4

No

Accelerated Ponseti versus Standard Ponseti

Morcuende et al, 2005

Unclear

No

Yes

Yes

Yes

Unclear

Yes*7

Ponseti with AFO versus Ponseti with DBB

Janicki et al, 2011

Unclear*8

Yes

Yes

Yes

Yes

Unclear*8

Yes*9

*1intermediate follow-up (i.e. not into skeletal maturity) and difference in mean age (and length of follow-up?) between treatment groups

*2no predefined criteria for outcome measure (surgical recurrence)

*3short follow-up that differs per treatment group

*4no data on bracing compliance

*5multiple testing (without correction)

*6potential selection bias with respect to outcome measure (severity of surgical recurrence)

*7groups not comparable at baseline

*8cohort with historic control, no data on clubfoot severity at baseline, but groups are likely to be comparable

*9no data on bracing compliance

 

Methodology checklist – intervention studies

(The criteria used in this checklist are adapted from GRADE)

Research question: what is the optimal treatment for congenital idiopathic clubfoot? 

Study reference

 

(first author, year of publication)

There was adequate concealment of allocation 

 

(yes/no/unclear)

Participants receiving care were kept ‘blind’ to treatment allocation

 

(yes/no/unclear)

Care providers were kept ‘blind’ to treatment allocation

 

(yes/no/unclear)

Outcome assessors were kept ‘blind’ to participants’ exposure to the intervention

 

(yes/no/unclear)

 Use of unvalidated or intermediate 

outcomes

 

(yes/no/unclear)

Selective outcome reporting on basis of the results

 

(yes/no/unclear)

Loss to follow-up/ incomplete outcome data described and acceptable

 

(yes/no/unclear)

Analysis by

intention to treat

 

(yes/no/unclear)

Other limitations

 

(yes/no/unclear)

Ponseti versus posteromedial release

Adegbehingbe et al., 2010

Yes

No (not possible)

No (not possible)

Yes

Unclear*1

No

No*2

Unclear*3

Yes*4

Zwick et al, 2009

No

No

No

Unclear

No

No

Yes

Yes

Yes*5

Ponseti versus Kite

Rijal et al, 2010

Unclear

No

No

Yes

No

No

Yes

Yes

Yes*6

Sanghvi and Mittal, 2009

Unclear

No

No

No

Yes*7

No

Yes

Yes

Yes*7

Sud et al, 2008

No*8

Yes

No

Yes

Yes

No

Unclear

No

Yes*9

Accelerated Ponseti versus standard Ponseti

Harnett et al, 2011

Unclear

No (not possible)

No (not possible)

Yes

No

No

Yes

Yes

Yes*10

Ponseti with fiberglass casting versus standard Ponseti (Paris casting)

Pittner et al, 2008

Unclear

No

No

No

No

No

Yes

No

Yes

*1need for extensive surgery used as a proxy for treatment success but no information on foot function (and only short follow-up)

*2patients with short follow-up were excluded; no information provided on these patients

*3see (*2), if patients were excluded post-randomization, this is not an ITT analysis

*4large age difference between groups at baseline and in length of follow-up at end of study

*5very small study with multiple testing; trial stopped early for benefit

*6several subgroups, low number of participants (short follow-up, no information on foot function)

*7primary outcome measure (functional scoring system according to Atal et al, 1992) not validated, low number of participants (short follow-up)

*8improper randomization method (alternating allocation)

*9no functional outcome measure, short length of follow-up, primary outcome measure (treatment success based on physician’s judgment) not validated

*10 short length of follow-up