Development of an interventional pain management specific instrument for methodologic quality assessment of nonrandomized studies of interventional techniques.
BACKGROUND
The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for interventional pain management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a "gold standard," but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for interventional techniques.


OBJECTIVE
Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of interventional techniques.


METHODS
The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized.


RESULTS
A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria.


CONCLUSIONS
Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations.


CONCLUSIONS
We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of interventional techniques. This instrument provides extensive information specific to interventional techniques is useful in assessing the methodological quality and bias of observational studies of interventional techniques.
Pain Management Center of Paducah, Paducah, KY and University of Louisville, Louisville, KY; Massachusetts General Hospital and Harvard Medical School, Boston, MA; Texas Tech University Health Sciences Center, Lubbock, TX.
Laxmaiah
L
Manchikanti
Joshua A
JA
Hirsch
James E
JE
Heavner
Steven P
SP
Cohen
Ramsin M
RM
Benyamin
Nalini
N
Sehgal
Frank J E
FJ
Falco
Ricardo
R
Vallejo
Obi
O
Onyewu
Jie
J
Zhu
Alan D
AD
Kaye
Mark V
MV
Boswell
Standiford
S
Helm
Kenneth D
KD
Candido
Sudhir
S
Diwan
Thomas T
TT
Simopoulos
Vijay
V
Singh
Vidyasagar
V
Pampati
Gabor B
GB
Racz
P Prithvi
PP
Raj
D061345:Early Medical Intervention / Q000379:methods / Q000592:standards*; D006801:Humans; D065228:Non-Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D059408:Pain Management / Q000379:methods / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000379:methods* / Q000592:standards*; D015203:Reproducibility of Results