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. 2013 Sep 10;2013(9):CD009796. doi: 10.1002/14651858.CD009796.pub2

Burckhardt 1994.

Methods Study setting: Europe (Sweden). Single‐centre, recruitment in occupational and primary health clinics, outpatient based
Study design: Parallel
Duration therapy: 6 weeks
Follow‐up: 3 and 6 months
Analysis: ANOVA (FIQ), MANOVA (QOLS‐S, FAI, SELF pain, SELF function, SELF other, 6‐min walk, chair test, myalgic score), if omnibus F significant ANOVA on individual outcomes, independent group t‐tests, paired different t‐tests for within group change
Participants Patients: Treatment group: 28 patients; Control group: 30 patients; Total sample:100% female, 99% white, mean age 46.5 years; Duration of symptoms not reported
Inclusion: ACR 1990 criteria for FM, normal results in laboratory tests (haemoglobin, free thyroxine, erythrocyte sedimentation rate, antinuclear antibodies, rheumatoid factor, creatine phosphokinase), understand Swedish
Exclusion: Other rheumatic diseases
Interventions Treatment Group: CBT, group: education, relaxation, assertiveness training, coping strategies, problem solving techniques (1x1.5h/week), total: 9h
Control Group: Delayed treatment control
Co‐medication allowed: Yes, not controlled for
Other Co‐therapies: Not reported
Outcomes Primary Outcomes
Self reported pain: FIQ pain 0‐10; SD not reported and not provided on request; SDs calculated by imputation method
Self reported negative mood: FIQ depression 0‐10; SD not reported and not provided on request; SDs calculated by imputation method
Self reported disability: FIQ physical impairment 0‐10; SD not reported and not provided on request; SDs calculated by imputation method
Acceptability: Total dropout rate
Secondary Outcomes
Self reported self efficacy pain: Self‐Efficacy (SES) pain scale 500‐50; SD not reported and calculated by reported P‐value
Self reported fatigue: FIQ fatigue 0‐10; SD not reported and not provided on request; SDs calculated by imputation method
Self reported sleep problems: Not assessed
Self reported disease‐specific health‐related quality of life: FIQ total 0‐80; SD not reported and not provided on request; SDs calculated by imputation method
Notes 1. Study arm CBT plus physical therapy not used for comparison
2. Reasons for drop‐out
‐Total sample: 6x did not return for retesting (no separate data reported
‐Experimental groups: 7x did only attend 1 or 2 classes
3. Attendance rates: Not reported
4. Responder analysis: None
5. Funding sources and declaration of interest of the primary researchers: No details reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No detailed information
Allocation concealment (selection bias) Unclear risk No detailed information
Incomplete outcome data (attrition bias) 
 All outcomes High risk No Intention‐to‐treat analysis
Selective reporting (reporting bias) High risk Except FIQ‐subscale scores all other outcomes not reported in detail at follow‐up and not provided on request
Blinding of outcome assessor Unclear risk No detailed information