Table 5.
Items on internal validity*.
Reference | 1.1 | 1.2 | 1.3 | 1.4 | 1.5 | 1.6 | 1.7 | 1.8 | 1.9 | 1.10 |
Study addresses appropriate, clearly focused question. | Treatment group assignment is randomized | Adequate concealment method is used. | Subjects and investigators are kept “blind” about treatment allocation. | Treatment and control groups are similar at the start of the trial. | Only difference between groups is the treatment under investigation | Outcomes are measured in a standard, valid and reliable way. | What % of subjects in each treatment arm dropped out before the study was completed | All subjects are analyzed in the groups to which they were randomly allocated (intention to treat analysis). | If the study is multi-site, results are comparable for all sites. | |
| ||||||||||
Krucoff et al. 2001 [16] | Well Covered | Well Covered | Well Covered | Adequately Addressed | Well Covered | Well Covered | Well Covered | (1) MANTRA = 2% | Well Covered | Not Applicable |
| ||||||||||
Krucoff et al. 2005 [17] | Well Covered | Well Covered | Well Covered | Adequately Addressed | Well Covered | Well Covered | Well Covered | (1) MIT + Prayer = 2% | Well Covered | Poorly Addressed |
(2) Prayer = 4% | ||||||||||
(3) MIT = 6% | ||||||||||
(4) UC = 5% | ||||||||||
| ||||||||||
Seskevich et al. [18] | Well Covered | Well Covered | Well Covered | Adequately Addressed | Well Covered | Well Covered | Well Covered | (1) MANTRA = 2% | Well Covered | Poorly Addressed |
| ||||||||||
Edelman et al. [19] | Well Covered | Well Covered | Poorly Addressed | Poorly Addressed | Adequately Addressed | Adequately Addressed | Well Covered | (1) PHP = 27% | Well Covered | Not Applicable |
(2) UC = 14% |
Abbreviations: CMA: Conventional medical analgesia; EA: Electro-acupuncture technique; PCB: Paracervical block; MIT: Music, imagery, and touch; PHP: Personalized health planning; SMT: Spinal manipulative therapy; TMS: transcranial magnetic stimulation; and UC: Usual care.
*Each item in Section 1 is to be evaluated using these criteria:
(i) well covered,
(ii) adequately addressed,
(iii) poorly addressed,
(iv) not addressed (i.e., not mentioned, or indicates that this aspect was ignored),
(v) not reported (i.e., mentioned, but insufficient detail to allow assessment),
(vi) not applicable.