Kadanka 2002.
Methods | C: Coin toss
Outcome assessor blind
Exclusions during trial: 2 (patients initially allocated to the conservative group, but underwent surgery) Losses to FU: 19 between 24 and 36 months. In addition 5 patients who underwent surgery died during the same period |
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Participants | Czech Republic 68 patients (48 men and 20 women) age<75 Mild to moderate myelopathy (mJOA score>12) |
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Interventions | Rx :22 anterior decompression (with autograft, 15 had additional plating), 6 corpectomy and 5 laminoplasty Conservative treatment: intermittent cervical immobilization (soft collar), NSAIDs, intermittent bed rest |
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Outcomes | modified JOA score at onset, 6,12, 24 and 36 months after treatment evaluation of daily activities by video recording at onset, 6,12 ,24 and 36 months after treatment timed 10‐meter walk at onset, 6,12, 24 and 36 months after treatment self‐evaluation at onset, 6,12, 24 and 36 months after treatment |
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Notes | Ex: severe myelopathy (mJOA <12) FU: 3 years | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | coin toss |
Allocation concealment? | Unclear risk | not stated |
Blinding? patients | High risk | |
Blinding? care providers | Unclear risk | not stated, but unlikely |
Blinding? outcome assessor | Low risk | "They were evaluated by two physicians blinded to the type of treatment" |
Incomplete outcome data addressed? Withdrawal/drop‐out rate | High risk | Five surgically treated patients died during the follow‐up period, but their deaths were physically unrelated to the surgery 19 patients were lost to follow‐up between 24 and 36 months |
Incomplete outcome data addressed? Intention‐to‐treat analysis | High risk | Two patients allocated to the conservative group underwent surgery and they were excluded from the analysis |
Free of selective reporting? | Low risk | |
Similarity of baseline characteristics? | High risk | mJOA score substantially‐almost significantly‐ different between surgically and conservatively treated groups |
Co‐interventions avoided or similar? | Unclear risk | A variety of non surgical interventions were administered to the conservatively treated patients |
Compliance acceptable? | Low risk | |
Timing outcome assessments similar? | Low risk |