[Summary text]
Study design:
Study grouping:
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Kontrol
Included criteria: < 3 weeks of LBP and/or radiculopathy
Excluded criteria: Ej beskrevet
Pretreatment: Therewere no statistically significant differences in demographics,absenteeism, intensity of pain, or general health (GH) in the 2arms at baseline, though Roland scores tended to be higher forthe unblinded arm (mean 14) than the blinded arm(mean 12; P .054; Table 1).
Intervention Characteristics
Intervention
Kontrol
Sygefravær - antal dage (Sick leave - no of days)
Sponsorship source: The study was supported by National Institutes of Health grant R01 HD36874-01 on the“Natural History of Acute Low Back Pain and/or Radiculopathy and the Role of DiagnosticImaging.”
Country: USA
Setting: primær og sekundær sektor
Comments:
Authors name: Ash, L.M.
Institution: The Division of Radiology and Department of Quantitative Health Sciences , Cleveland Clinic Foundation, Cleveland, Ohio, USA
Email: lorrainemash@gmail.com
Address: Lorraine M. Ash, Department of Radiology, 1500 E, Medical Center Dr, B2 A209, Ann Arbor, MI 48109-0030; USA
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
Judgement Comment: Stor risiko for recall bias ved 12 mo follow up
Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Ej beskrevet
no info
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: ingen protokol tilgængelig
no info
No info
no info
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Ej beskrevet
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Judgement Comment: Ej rapporteret
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Quote: "Intention-to-treat principle was used for entire sta- tistical analysis of the article."
Judgement Comment: Data available for all patients at 12 mon.