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
Quality items | Description of the random allocation: 1)Randomization method 2)Concealment | Treatment performed by appropriate and experienced person? | Is the intervention described? 1. SM 2. Sham 3.Comparison 4. Control | Is the assessment blinded? 1. Assessor/intervention 2.Statistician/intervention | The sham procedure: (Yes/No/NA) 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? (Yes/No/NA) | 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 |