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Table 2 Quality items, rationale for inclusion in quality assessment, interpretation and scoring used in a systematic review on spinal manipulation and pressure pain threshold

From: The regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects: a systematic literature review

Quality items Description of the random allocation:
1)Randomization method
Treatment performed by appropriate and experienced person? Is the intervention described?
1. SM
2. Sham
4. Control
Is the assessment blinded?
1. Assessor/intervention
The sham procedure:
1.Naïve subjects
2. In the same position as SM?
3. Assessed
Conclusion: Is the sham psychologically acceptable (1 pt), possibly acceptable (0.5 pt), not acceptable (0 pt)
If no sham procedure, at least are the subjects naïve?
Is the measurement procedure described? Is reliability of the outcome variables reported? Were pain readings taken more than once at each point? After the study started, are losses and exclusions of study subjects reported or evident?
Rationale for inclusion in quality assessment 1)Ensuring equal distribution of study subjects
2) Prevent risk of cheating during group allocation and risk of bias during assessment
Ensuring interventions are appropriately administered Ensuring that study can be reproduced 1Preventing risk of assessor bias
2.Preventing “data massage”
Assuring the credibility of the sham both from a psychological and physiological aspect Ensuring that there is no risk of participant bias Ensuring that study can be reproduced As validity is difficult to obtain ensuring that, at least, the outcome variable is reliable More than one reading is needed to avoid unrepresentative data Making it possible to detect risk of exclusion/attrition bias
Interpretation details (where relevant) 1).as it said that participants were allocated into groups in a random fashion?
2) Was it stated that groups were concealed during random allocation?
Appropriate: practitioner with training in SM
We believed the study when authors reported some sort of experience or expertise for the treating clinicians
If we understood what had been done in the experiment, we considered this acceptable This had to be stated in the text 1–3. A sham procedure may be able to “fool” a study subject but… This had to be stated in the text If we understood the procedure, we considered this acceptable This could be reported with a reference to previous study or a reliability study could be reported in the Result section This had to be stated in the Method or Result section This had to be stated or obvious from information given in Tables or Result section
Scoring 1. 0.5 pt.
2. 0.5 pt
1 pt 1 pt 1. 0.5 pt.
2. 0.5 pt
1 or 2: 0.5 pt.
1 + 2: 1 pt.
3 found acceptable: 1 pt.
3 not found acceptable: 0 pt.
Conclusion: Is the sham psychologically acceptable (when 1 pt. is given), possibly acceptable (when 0.5 pt. is given), not acceptable (when 0 pt. is given)
Yes: 1 pt.
No: 0 pt.
If NA, this case is not taken into account.
1 pt 1 pt 1 pt 1 pt
  1. SM Spinal Manipulation, NA Not Applicable