Table 2.
Characteristic | Alaranta 199415 | Basler 199725 | Bendix 199618 | Bendix 199517 | Harkäpää 198921 | Jückel 199026 | Lukinmaa 198916 | Mitchel 199429 | Nicholas 199228 | Nicholas 199127 |
---|---|---|---|---|---|---|---|---|---|---|
Methodological quality: | ||||||||||
Concealment of allocation | × | × | × | × | × | × | √ | √ | √ | √ |
Blinding of care provider* | × | × | × | × | × | × | × | × | × | × |
Avoidance of co-interventions | √ | × | × | √ | × | × | × | × | √ | √ |
Acceptable compliance | √ | × | × | √ | √ | × | √ | × | × | √ |
Blinding of patient* | × | × | × | × | × | × | × | × | × | × |
Blinding of assessor† | × | × | × | √ | × | × | × | √ | √ | × |
Outcome measures relevant‡ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Acceptable dropout rate | √ | √ | √ | √ | √ | × | √ | √ | √ | × |
Comparable timing of assessment§ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Intention to treat analysis | × | × | √ | × | × | × | × | √ | × | × |
Total score (out of 10)* | 5 | 3 | 4 | 6 | 4 | 2 | 5 | 6 | 6 | 5 |
Clinical relevance¶: | ||||||||||
Detailed description of setting | √ | √ | × | × | √ | √ | √ | × | × | × |
Detailed description of participants | √ | × | √ | √ | × | × | √ | × | × | × |
Detailed description of intervention | √ | √ | √ | √ | √ | × | √ | × | √ | √ |
Control treatment described | √ | × | × | √ | √ | × | √ | × | √ | √ |
Relevant outcomes measured‡ | √ | × | √ | √ | √ | × | √ | × | × | × |
It could be argued that the maximum possible methodological quality score is 8 instead of 10, since blinding of care provider and patient might not be feasible with multidisciplinary interventions.
In the trial by Nicholas et al, a blinded assessor was available for 75% of the participants. Bendix et al quantified success of blinding of the assessor; blinding was broken for about 10% of participants.
In the internal validity scale proposed by the Back Review Group of the Cochrane Collaboration, a study that reports on at least one of pain, global improvement, back specific functional status, generic functional status, and return to work qualifies as “outcome measures relevant.” In the clinical relevance assessment, a study had to measure pain, back specific disability, and ability to work to qualify as “relevant outcomes measured.”
In the trial by Basler et al, both groups were assessed post-treatment, but six months' follow up is available only for the intervention group.
For the assessment of clinical relevance, we had access to the full Finnish report on the studies by Alaranta et al, Lukinmaa et al, and Harkäpää et al.