[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label: YES
Cluster RCT:
Baseline Characteristics
Rest
Advice
Exercise
Included criteria: radicular pain had to be o f Jess than l month 's duration, and patients had to be younger than 60 years of age
Excluded criteria: cauda equina syndrome or severe weakness (Medical Research Council grade < 3) or ifthey had previously undergane bed rest or physiotherapy or were unwilling to comply with one of the three treatment strategies
Intervention Characteristics
Rest
Advice
Exercise
Bensmerte
Rygsmerte
Funktionsevne
Arbejdsevne (antal dage siden debut)
Arbejdsevne (andel tilbage til arbejde)
Arbejdsevne (andel m. Sygemelding)
Neurologiske udfald
Dropout
Antal lumbale operationer
Blodpropper
Sponsorship source: not repoerted
Country: The Nederlands
Setting: outpatient clinic
Comments:
Authors name: Hofstee
Institution: Departments af Neurology, Radiology, Neurosurge1y, and Physiotherapy, Medical Center Haaglanden, Westeinde, The Hague
Email: DJ.Hofstee@StJansdal.nl
Address: Derk J. Hofstee, M .D., Departmentof Neurology, St. Jansdal Hospital, P.O. Box 138, 3840 AC, Harderwijk, The Netherlands.
Birgitte Holm Petersen on 10/08/2015 12:28
Intervention Characteristics
Thereis no space for describing the interventions
Birgitte Holm Petersen on 10/08/2015 12:50
Continuous Outcomes
Radicular leg pain on visual analog pain scale (VAPS)Quebec Disability Scale (QDS)Jeg har brugt change scores og SD fra baseline (selv om det er af to forskellige ting - ved ikke om man kan det?), men man kan også regne baglæns og rapportere mean i grupperne (her er problemet bare at bed rest gruppen scorer 5 point højere ved baseline). Men forfatterne angiver at data er noget skævfordelte ved opfølgningerne, så derfor er changes scores vel bedre?
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label: YES
Cluster RCT:
Baseline Characteristics
Rest
Advice
Exercise
Included criteria: patients who presented with back pain radiating into one leg below the gluteal fold to the neurology department of Maastricht UniversityHospital. Patients were eligible for the study if the intensity of pain was sufficient to justify two weeks of bed rest as therapy.
Excluded criteria: previously undergone spinal surgery, were pregnant, had pending workers’ compensation claims, were unavailable for follow-up (i.e., planned to move),or had severe coexisting illnesses.
Intervention Characteristics
Rest
Advice
Exercise
Bensmerte
Rygsmerte
Funktionsevne
Arbejdsevne (antal dage siden debut)
Arbejdsevne (andel tilbage til arbejde)
Arbejdsevne (andel m. Sygemelding)
Neurologiske udfald
Dropout
Antal lumbale operationer
Blodpropper
Sponsorship source: Supported by Maastricht University and Maastricht University Hospital
Country: The Netherlands
Setting: Hospital, outpatient clinic
Comments:
Authors name: P ATRICK C.A.J. V ROOMEN
Institution: Departments of Neurology and Radiology, Maastricht University Hospital; and the Departments of Methodology and Statistics and Family Practice, Maastricht University — both in Maastricht, the Netherlands
Email: pvr@sneu.azm.nl
Address: Dr. Vroomen at the Department of Neurology, Maastricht University Hospital, P. Debyelaan 25, P.O. Box 5800, 6202 AZ Maastricht, the Netherlands
Birgitte Holm Petersen on 10/08/2015 13:56
Baseline Characteristics
Boxes to describe the interventions are lacking
Birgitte Holm Petersen on 10/08/2015 13:57
Intervention Characteristics
Boxes to describe the interventions are lacking
Wrong patient population
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
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: From Dahm 2010 (Cochrane Systematic Review)
Judgement Comment: Dahm 2010, Cochrane Systematic Review
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.
Judgement Comment: From Dahm 2010 (Cochrane Systematic Review)
Judgement Comment: Dahm 2010, Cochrane Systematic Review
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: From Dahm 2010 (Cochrane Systematic Review)
Judgement Comment: Dahm 2010, Cochrane Systematic Review
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: From Dahm 2010 (Cochrane Systematic Review)
Judgement Comment: Dahm 2010, Cochrane Systematic Review
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.
Judgement Comment: From Dahm 2010 (Cochrane Systematic Review)
Judgement Comment: Dahm 2010, Cochrane Systematic Review
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: From Dahm 2010 (Cochrane Systematic Review)
Judgement Comment: Dahm 2010, Cochrane Systematic Review
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: From Dahm 2010 (Cochrane Systematic Review)
Judgement Comment: Dahm 2010, Cochrane Systematic Review