[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: men aged from 16 to 45 years who were available for work; a clinical diagnosis of torn medial meniscus; the willingness of the patient to enter either group; and removal of the medial meniscus at operation
Excluded criteria: full-time students were excluded
Intervention Characteristics
Intervention
Control
Pain
Function
HRQOL
Sick leave
Employment retention
Symptoms
Muscle strength
SAE
Function (gait impaired)
return to work (failed)
Sponsorship source: WearegratefultotheDHSSforagrantforthisstudy.TheMedicalCareResearchUnitisalsosupportedbyTrentRHA.WeareparticularlygratefultoMrsASwindellsforthephysiotherapyassessments;toMrTMcDonaldandothersforphysiotherapytreatments;toMrDKEvans,MrWJWSharrand,MrTWDSmith,andProfessorTDuckworthforallowingtheirpatientstoenterthetrial;toMrsJGyteforcoding;andtoMrJBradley,ProfessorJKnowelden,andtheDHSSforadvice.
Country: Great Britain
Setting: Three Sheffield hospitals.
Comments:
Authors name: DP FORSTER
Institution: DepartmentofFamilyandCommunityMedicine,UniversityofNewcastleuponTyne,NewcastleuponTyneNE17RU)
Email: Ingen mail
Address: MedicalCareResearchUnit,DepartmentofCommunityMedicine,UniversityofSheffieldMedicalSchool,SheffieldS102RX
Jonas Larsen on 13/08/2015 07:22
Baseline Characteristics
Ikke beskrevet udover inklusionskriterier og 34 variable som ikke beskrives nærmere?
Jonas Larsen on 13/08/2015 07:25
Intervention Characteristics
Ikke beskrevet
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: between 18 and 60 years of age and underwent an uncomplicated arthroscopic partial meniscectomy
Excluded criteria: any concurrent injuries to their contralateral lower extremity that required medical attention, if they had any neurological disorders affecting their lower extremities, or if they were expect- ing surgery within 6 months following their arthroscopy
Intervention Characteristics
Intervention
Control
Pain
Function
HRQOL
Sick leave
Employment retention
Symptoms
Muscle strength (Quadriceps)
SAE
Sponsorship source: Grant from National Health Service Executive, London Regional Office, Responsive Funding Programme
Country: London, UK
Setting: Hospital/health care trust/University/College
Comments:
Authors name: PC Goodwin, MC Morrisey, RZ Omar, M Brown, K Southall, TB McAuliffe
Institution: Centre for Applied Biomedical Research, GKT School of Biomedical Sciences, King’s College London, London, United Kingdom.
Email: matt.morrissey@kcl.ac.uk
Address: Shepherds House, Guy's Campus, London SE1 1UL, UK
Birgitte Holm Petersen on 15/08/2015 20:09
Baseline Characteristics
Også data i artiklen om:job-pause FØR surgeryhvilke(n) menisk skadet
Birgitte Holm Petersen on 15/08/2015 20:19
Continuous Outcomes
Sygefravær er en brøk (FORS) - vanskelig at omsætte
Jonas Larsen on 18/08/2015 06:13
Pretreatment
The groups were very similar for all characteristics. The number of days absent from work prior to surgery contained an outlying value of 1,600 days in the intervention group, but no difference was found between the intervention and control groups, either with or with out this value.
Jonas Larsen on 18/08/2015 06:34
Baseline Characteristics
Supplerende characteristics udover angivet nedenfor (middelværdier): Control group Intervention groupHeight (cm) 174 (157 to 192) 176 (157 to 192)Mass (kg) 84 (54 to 123) 80 (57 to 110)Sex 35 male, 6 female 39 male, 6 femaleNo. of days absent from 2 (1 to 7) 64 (0 to 1,600)work prior to surgeryDuration of injury (years) 2.4 (0.5 to 25.7 y) 1.7 (0.5 to 14.2 y)Period from surgery to pretest measurement (days) 6 (2 to 10) 5 (2 to 9)Passive knee flexion (difference injured and uninjured knees) (°) 39 (5 to 93) 44 (0 to 110) Suprapatellar knee girth (difference injured and uninjured knees) (cm) 1.3 (-1.0 to 4.0) 1.4 (-1.5 to 3.5)Injured side Left13, right28 Left22, right23Meniscus involved Medial 30 Medial 34 Lateral 9 Lateral 10 Medial and lateral 1 Medial and lateral 1 Not reported
Jonas Larsen on 18/08/2015 15:03
Continuous Outcomes
Control group Intervention group Baseline 6 wk. postsurgery Baseline 6 wk. postsurgeryHughston Clinic questionnaire score Mean 59.1 (SD 17.3) Mean 24.8 (SD 16.7) Mean 85.5 (SD 14.8) Mean 27.7 (SD 18.4)SF36 Mean 0.69 (SD 0.10) Mean 0.76 (SD 0.10) Mean 0.68 (SD 0.12) Mean 0.75 (SD 0.12)EQ-5D Mean 0.54 (SD 0.20) Mean 0.81 (SD 0.12) Mean 0.56 (SD 0.22) Mean 0.75 (SD 0.21)Maximum-minimum kneeangle during stair ascent stance phase (degrees) Mean 40 (SD 8) Mean 51 (SD 5) Mean 42 (SD 6) Mean 49 (SD 6)Injured/unijured limb vertical jump ratio Not tested Mean 0.82 (SD 0.18) Not tested Mean 0.88 (SD 0.19)No of days taken to return to work after surgery/FORS score Not tested Mean 1.4 (SD 1.5) Not tested Mean 1.5 (SD 1.8)
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: no history of previous knee surgery on either extremity, the willingness to be random- ized into either of the study groups postoperatively, absence of significant other knee joint pathology (i.e., severe degenerative joint disease), and ab- sence of severe medical conditions
Excluded criteria: Intet yderligere udover inclusions criteria
Intervention Characteristics
Intervention
Control
Pain
Function
HRQOL
Sick leave
Employment retention
Symptoms
Muscle strength (Quadriceps)
SAE
Sponsorship source: none
Country: USA
Setting: Hospital and Home
Comments: kun 8 ugers opfølgning
Authors name: P. Jokl, P. Stull, J. Lynch & V. Vaughan
Institution: Dep. of Orthopaedics and Rehab., Yale University School of medicine
Email: no
Address: Dr. Peter Jokl, Professor of Orthopaedics and Rehabilitation, Yale Univer- sity School of Medicine, 240 Sargent Drive, New Haven, CT 06511, U.S.A.
Jonas Larsen on 14/08/2015 06:55
Baseline Characteristics
Karakteristika udover nedenstående tabel: Group 1 Group 2Knee involved: 9 right, 6 left 8 right, 7 left Meniscus affected: 13 medial/2 lateral 11 medial/4 lateral Duration ofsymptoms: Mean 21.3 weeks Mean 37.4 weeks SD 37.5 SD 49.6 Range 3-150 weeks Range I-200 weeks Tear type: Bucket handle 5 Bucket handle 4 Flap 9 Flap 11 Horizontal cleavage 1 Horizontal cleavage 1Surgeon: P.J. 7 P.J. 10 K.L. 8 K.L. 5
Jonas Larsen on 14/08/2015 07:28
Continuous Outcomes
De relevante outcomes som ikke kunne komme i nedenstående tabel er indsat her:Summary og qualitative assessments of knee function: Week 2 Week 4 Week 8 Group 1 Group 2 Group 1 Group 2 Group 1 Group 2 (n) (n) (n) (n) (n) (n) Knee gives away: 3 5 1 4 1 1Difficulty stairs: 9 10 5 3 2 1Difficulty crouching: 9 12 6 9 2 5Limping: 4 3 1 2 0 0Return normal activities: 7 9 10 12 13 13 Return sports: 0 0 1 4 8 9Patients subjective evaluation of knee pain: Severe Moderate Mild None Group 1 Group 2 Group 1 Group 2 Group 1 Group 2 Group 1 Group 2 Week 2 1 0 4 2 4 10 4 2Week 4 0 0 1 1 5 9 8 5 Week 8 0 0 0 1 3 4 11 10Patients overall assessment of knee function at final evaluation: Excellent Good Fair PoorGorup 1 9 4 0 0Group 2 9 4 1 0
Birgitte Holm Petersen on 15/08/2015 21:01
Pretreatment
All patients from private praxis
Birgitte Holm Petersen on 15/08/2015 21:01
Continuous Outcomes
ingen VAS-score eller lignendeTABLE 2 GIVER IKKE MULIGHED FOR AT UDTRÆKKE DATA
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
control
Included criteria: Subjects with knee pain for more thantwo months, who were 35e60 years of age and eligible forarthroscopic partial meniscectomy, with an MRIefrom theradiologist’s descriptioneshowing a degenerative meniscustear.
Excluded criteria: ACL rupture and thoserequiring acute trauma surgeries, including high energytraumas with ligament injuries, osteoarthritis grade 3e4(Spector and Cooper, 1993), hemarthroses and acute cases oflocking knee, comorbidities excluding physical activities andexercise, and drug abuse
Intervention Characteristics
Intervention
control
Pain
Function (activity and participation)
HRQOL
Sick leave
Employment retention
Symptoms
Muscle strength, 5 RM
SAE
Muscle strength, quadriceps peak torque
Hospital Anxiety and Depression Scale (HADS)
One-leg jump test
Sponsorship source: No
Country: Norway
Setting: Hospital
Comments: KOOS and other measures was also evaluated. But the subscale scores of KOOS was not given, which is why this was not included in the extraction.
Authors name: Østerås H
Institution: Faculty of Health Educationand Social Work, Department of Physical Therapy
Email: havard.osteras@hist.no
Address: Ranheimsv. 10, N-7004 Trondheim, Norway
Birgitte Holm Petersen on 21/07/2015 21:17
Continuous Outcomes
Funcion = one-leg-jumpHAD=HRQOLlongest followUP=12 mdr
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
control
Included criteria: subjects with knee pain for more than two–three months, being between the ages 35 and 60 years and eligible for arthroscopic partial meniscectomy and having an MRI showing a degenerative meniscus tear
Excluded criteria: An ACL rupture, those requiring acute trauma surgeries, those having high-energy traumas with ligament injuries, an osteoarthritis grade of 3–4, hemarthroses and acute cases of locking knee. In addition, the following were also included in the exclusion criteria: symptomatic pain in contrary extremity- and other musculoskeletal comorbidities severely affecting lower extremity muscle function overriding the symptoms from the knee, comorbidities that exclude physical activities and exercise, not being able to speak or read the language of interest, drug abuse or mental problems.
Intervention Characteristics
Intervention
control
Pain
Function (activity and participation)
HRQOL
Sick leave
Employment retention
Symptoms
Muscle strength, 5RM
SAE
Hospital Anxiety and Depression Scale (HADS)
One-leg hop test
Sponsorship source: ikke angivet
Country: Norway
Setting: Hospital
Comments: KOOS and other measures was also evaluated. But the subscale scores of KOOS was not given, which is why this was not included in the extraction.
Authors name: Østerås, H
Institution: Sør-Trøndelag University College, Faculty of Health Education and Social Work, Department of Physical Therapy
Email: havard.osteras@hist.no
Address: Ranheimsv 10, N-7004 Trondheim, NORWAY
Birgitte Holm Petersen on 22/07/2015 02:24
Continuous Outcomes
Pain=VASFunktion=one-leg hopHRQL=HAD
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Only those patients who were found at operation to have a tear of the medial meniscus and who had a routine medial meniscectomy
Excluded criteria: Those having a normal medial meniscus or any other joint pathology other than a torn medial meniscus apart from minimal laxity of the anterior cruciate ligament.
Intervention Characteristics
Intervention
Control
Pain
Function
HRQOL
Sick leave
Employment retention
Symptoms
Muscle strength (Quadriceps)
SAE
Sponsorship source: Ikke angivet
Country: England
Setting: Infirmary
Comments:
Authors name: N. Seymour
Institution: The Royal Infirmary, Sheffield
Email: Ikke aktuelt
Address: Ikke angivet
Jonas Larsen on 13/08/2015 17:54
Baseline Characteristics
Ikke beskrevet
Jonas Larsen on 14/08/2015 08:03
Continuous Outcomes
Effusion: Baseline 3 months Sum af grading (0-3 pr. patient) Sum af grading (0-3 pr. patient)Group A 32 3Group B 34 17ROM: 10 days postop. 3 months postop. Average flexion Average flexionGroup A 45 67Group B 135 137 Time of return to work and full activities (ingen tal/statistik på dette):No difference between groups. Average of 4 1/2 weeks for sedentary workers and 6 1/2 weeks for manual workers.Almost all patients in both groups were undertaking nearly full activities after 3 months postop.
Wrong intervention
Wrong study design
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: konsekutiv inrollment
No information/12 kirurger henviser til projektet -
Quote: "Thirty patients derived from the private practices of two orthopaedic surgeons were entered blindly into the study after an arthroscopically confirmed diagnosis of a meniscal tear treated by arthroscopic partial meniscectomy. Criteria"
The same investi- gator, who was not involved in the randomization procedure, prepared all the envelopes in the study.
computer-generated randomization schedule was used, with annotations for treatment according to medical exer- cise therapy or no postoperative rehabilitation.
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: kun folk med job - akt/pass - konsekutivt
blok randomisering, men ikke beskrevet om det var brev/pc/andet
Judgement Comment: TILFÆLDIGT HENV FRA PRIV PRAX
A computer-generated randomization schedule was used, with annotations for treatment according to exercise therapy or no postoperative rehabilitation.
Allocation concealment not described sufficiently.
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: not possible
ikk muligt
Neither participants nor personnel could be blinded
Blinding of participants and personnel not possible. Annotation unrelated to blinding.
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.
(for 'gait impaired')
ikke muligt
Outcome assessor not blinded
Outcome assessor not blinded
(for sick leave)
ikke muligt
Measures less likely to be affected by lack of blinding
Measures less likely to be affected by lack of blinding 3 forskellige fys træner
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.
one patient in the control group lost to follow up
få bortfald No other information that that above and information reasons for attrition in Figure 6 (relatively balanced between groups). It seems like as-treated analysis was applied, which are increasing the risk of bias, but since little information was provided in the paper on missing data unclear was chosen by one rew, however, stated LOW alltogether
meget få dropouts 7-8% As-treated analysis was applied instead of ITT-analysis, because the drop-out rate was low, which is not a valid argument. However, attrition rates and reasons were given in Fig 1 and seems relatively balanced between groups.
Judgement Comment: Der mangler præcise data på "time of return to work". Det er dog beskrevet med ord. Ingen statistiske beregninger på resultater i tabel 1-4.
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: ikke alle data reported
Judgement Comment: MANGLER BASISDATA
No information provided, and no registration number of the study protocol are given or can be located.
No registration number for the trial was given or found, nor a link to the study protocol.
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: Gammelt studie!Relevant outcome er antal sygedage/time to return to work. Men kvalitative og clinical outcomes er ikke de mest relevante og valide (som eksempelvis smerte, muskelstyrke, PROs m.m.). Derudover beskrives ikke hvorfor der mangler test på enkelte testpersoner. Men dette har måske ikke betydning.
Judgement Comment: Lille population
Judgement Comment: Gammelt studie med postoperativt regime som ikke er aktuelt i dag. Nogle outcomes er irrelevante eller upålidelige.