[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria were home-dwelling 60+ years old individuals with symptomatic HOA who met the clinical criteria of HOA according to American College of Rheumatology (24), and who were not on a waiting list for hip replacement.
Excluded criteria: Exclusion criteria were: 1) symptomatic osteoarthritis of the knee or the big toe, 2) prior hip or knee replacement, 3) other types of arthritis, 4) previous hip fracture, 5) co-morbidity that prevented exercising, 6) inability to use public transportation, 7) treatment related to hip problems within the last 3 months, and 8) performing exercise/sports regularly twice or more weekly
Pretreatment:
Intervention Characteristics
Intervention
Control
Patientrapporteret funktionsevne
Præstationsbaseret funktionsevne
Smerte (hofte)
Helbredsrelateret livkvalitet
Træningsinducerede skader i bevægeapparatet
Smerte (ikke hofterelateret)
Sponsorship source: This work was supported by the TrygFonden (1190-09), Nordea Foundation (Healthy Ageing grant), Health Foundation (2009B097), Danish Rheumatism Association (R56-Rp2380), Lundbeck Foundation (FP50/2009), School of Physical Therapy in Copenhagen,The Association of Danish Physiotherapists Research Fund.
Country: Denmark
Setting:
Comments:
Authors name: Bieler, 2013
Institution: Musculoskeletal Rehabilitation Research Unit, Department of Physical & Occupational Therapy, Copenhagen University Hospital, Bispebjerg, Denmark. Institute of Sports Medicine Copenhagen, Copenhagen University Hospital, Bispebjerg and Center for Healthy
Email: tbie0001@bbh.regionh.dk
Address:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Eligible participants were: All patients diagnosed with primary hip OA aged 50 years or older, scheduled for THA at the Department of Orthopaedic Surgery, Herlev University Hospital, Copenhagen, Denmark
Excluded criteria: Exclusion criteria were: Rheumatoid arthritis and other types of arthritis not diagnosed as OA, uraemia, cancer, treatment with sys-temic glucocorticoids>3 months the last 5 years with a dose >/=5mg, present or previous hip fracture (either side), other lower extremity fracture within 1 year prior to inclusion, body weight>135 kg, severe walking deficits (dependency of two crutches or walker for mobilization), or not speaking Danish language.
Pretreatment:
Intervention Characteristics
Intervention
Control
Patientrapporteret funktionsevne
Præstationsbaseret funktionsevne
Smerte (hofte)
Helbredsrelateret livkvalitet
Træningsinducerede skader i bevægeapparatet
Smerte (ikke hofterelateret)
Sponsorship source: the Danish Rheumatism Association (project no: R87-A1408)
Country: Denmark
Setting:
Comments:
Authors name: Hermann, 2016
Institution:
Email:
Address:
Wrong intervention
Wrong intervention
Wrong comparator
Wrong study design
Wrong intervention
Wrong intervention
Wrong intervention
Wrong intervention
Wrong study design
Wrong intervention
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 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: Blinded outcome assessor
n
n
Blinded outcomes assessor, but participant
self reported pain and function (Fransen 2014)
n
Quote: "major limitation to the study is the risk of assessor bias, i.e., a combined test and training site was used which made sufficient masking impossible. Assessor bias may cause invalid conclusions regarding the intervention effect 48. In order to diminish this source of bias, a standardized protocol was followed strictly during the collection of muscle power outcomes. Moreover, the HOOS ques- tionnaire which included the primary endpoint was a patient- reported outcome and answered without involvement by the assessor and therefore should not be subject to assessor bias. The data registration was performed blinded for allocation by a third person otherwise no involved in the study."
Judgement Comment: Data not used
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: Patiens and personnel not blinded
Fra SR Fransen 2014
Judgement Comment: Not possible to blind
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: Double testing of physical outcomes at baseline to account for learning effect. No intention-to-treat analysis (however performed for the published paper)
About 40% on orthopaedic waiting list
Exercise for. Fra SR Fransen 2014
Quote: "The shorter time of up to 6 weeks to surgery in the control group may hamper the internal validity. On the other hand this has strengthened the external validity as this would happen in the daily clinic."
Judgement Comment: Maybe some selection bias leading to low generalisability as only 40 % of eligible patient accepted participation (80 out of 210)
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: 4% drop out in intervention group and 17% drop out in control group. Total of 11% drop out
Fra SR Fransen 2014
Quote: "Three patients were lost to follow-up: One patient (control) dropped out after baseline due to unwillingness to further testing and one patient (intervention) dropped out between baseline and start up of intervention due to the delay of surgery in the inter- vention group compared to care-as-usual. One patient (inter- vention) was excluded due to medical illness not related to the study (pneumonia). There"
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.
Quote: "This procedure was conducted by a member of the research team, who was not involved in assessment or training of the participants."
Judgement Comment: Randomisation procedure handled by team members not otherwise involved
Fra SR Fransen 2014
Quote: "numbered closed envelopes containing allocation was produced by a person not otherwise affiliated with the study and concealed from the person enrolling the patients."
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Quote: "This procedure was conducted by a member of the research team, who was not involved in assessment or training of the participants."
Fra SR Fransen 2014
Quote: "A com- puter generated randomization sequence was used and sequen- tially numbered closed envelopes containing allocation was produced by a person not otherwise affiliated with the study and concealed from the person enrolling the patients."
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: None apparent, pre-registered trial
Fra SR Fransen 2014
Judgement Comment: No sign of selective outcome reporting