Background
Methods
Results
The first choice/appraisal to be made when planning/assessing a RCT → Characteristics of RCTs aiming to study effectiveness per se or in routine health care ↓ | RCT aiming to study effectiveness of an intervention per se | RCT aiming to study effectiveness of an intervention in routine health care circumstances |
Study design | Double-blinded study design | Non-blinded study design |
Validity for assessing effectiveness of intervention per se | Valid design | Not a valid design |
Validity for assessing intervention effectiveness in routine health care | Not a valid design | Valid design |
Appropriateness for informing patients in routine health care; including use of number needed to treat (NNT) figures from double blinded RCTs | May give biased estimates, and in case of a placebo controlled trial, estimates may undervalue the effectiveness in routine health care | Gives non-biased estimates for intervention effectiveness in a particular routine health care; evidence is generalizable to similar patient, intervention, and health care contexts |
Validity of cost-effectiveness estimates and incremental cost-effectiveness ratios (ICERs) in relation to routine health care | May give biased estimates, and in case of a placebo controlled trial, may undervalue the cost-effectiveness in routine health care | Gives non-biased estimates for intervention effectiveness in a particular routine health care. |
Appropriateness of blinding of patients and health care providers as validity criteria of individual RCTs | Yes | No |
Appropriateness for assessing efficacy (i.e. effectiveness in ideal circumstances) of interventions | Yes | Yes |
Capability to provide effectiveness estimates applicable to everywhere anytime | No | No |
Study question dictates double blinded study design
Study question dictates non-blinded study design
The study questions in RCTs on arthroscopic partial meniscectomy
Year, Study, country → ↓Study characteristics | 2007 and 2013, Herrlin et al. [12] Sweden | 2013, Katz et al. [13] USA | 2013, Sihvonen et al. [14] Finland | 2013, Yim et al. [15] South-Korea | 2014, Gauffin et al. [16] Sweden | 2016, Kise et al. [17] Norway |
---|---|---|---|---|---|---|
1. Study type | ||||||
1.1. Assessment of intervention effect per se | No | No | Yes | No | No | No |
1.2. Assessment of real world effectiveness | Yes | Yes | No | Yes | Yes | Yes |
2. Selection of patients | ||||||
2.1. Eligiblity criteria | 45–64 years; knee pain without a trauma, daily or almost daily pain during last 2–6 months; knee osteoarthritis (Ahlbäckc grade 0 or 1); medial meniscal tear on MRI | Symptomatic (at least four weeks) patients ≥45 years with a meniscal tear and osteoarthritis on MRI or radiography Excluded: Chronically locked knee, Kellgren-Lawrence grade 4 | 35 to 65 years; knee pain for > 3 months; clinical findings consistent with a tear of the medial meniscus and verified by MRI. Excluded: obvious traumatic onset or knee osteoarthritis (Kellgren-Lawrencec grade > 1) | Degenerative horizontal tear of the posterior horn of the medial meniscus on MRI; daily knee pain Exclusion: a history of definite trauma | age 45–64, symptoms more than 3 months, Ahlbäckc grade 0 in X-rays; had undergone prior physiotherapy | 35–60 years; unilateral knee pain more than two months without a major trauma; medial degenerative meniscal tear by MRI; radiographic changes at most, grade 2 byKellgren-Lawrencec |
2.2. Description of patients’ clinical path before being eligible | No | Noa | No | No | Yes | No |
2.3. Comprehensive population of catchment area | No | No | No | No | Yes | No |
2.3. Place and time of recruitment. Number of patients per hospital year. | 1 orthopedic clinic; June 2003 to Apr 2005 → 82 patients per hospital per year | 7 tertiary centers; from June 2008 to Aug 2011 → 16 patients per hospital per year | 5 orthopedic clinics; Dec 2007 to Jan 2013 → 6 patients per hospital per year | 1 orthopedic clinic; Jan 2007 to July 2009. → 43 patients per hospital per year | 1 orthopedic clinic; Mar 2010 to Apr 2012 → 71 patients per hospital per year | 2 hospitals; Oct 2009 to Sep 2012 → 23 patients per hospital per year |
2.4. Declining participation N (%) | 40% | 433/784 (55%) | 24/205 (12%) | 49/162 (30%) | 5/179 (3%) | 85/226 (38%) |
2.5. Pre-intervention therapy | No | Medications, activity limitation or physical therapy for at least 4 weeks | Conventional conservative treatment | No | Physiotherapy (exercise) for at least 3 months | No |
2.6. Verification of diagnosis | Clinicallyb and by MRI | Clinically and by MRI | Clinically and by arthroscopy | Clinically and by MRI | Clinically | Clinically and by MRI |
2.7. Osteoarthrosis (OA); based on X-rays/MRI | Yes or no OAc: X-rays only | Yes or no OAc: X-rays; Yes OA: MRI | No OAc: X-rays only | No OAc: X-rays only | No OAc: X-rays only | Yes or no OAc: X-rays only |
2.8. History of a trauma as an exlusion or inclusion criterion | Excluded: Traumatic knee pain | Included: Sudden onset of symptoms; Excluded: locked knee | Excluded: Obvious traumatic onset | Excluded: History of definite trauma | Included: Sudden onset of symptoms; Excluded: locked knee | Excluded: Sudden onset of symptoms |
3. Baseline characteristics (incl. Primary outcomes) | ||||||
3.1. Number of patients | 180 (data on 90) | 351 | 146 | 108 (data on 102) | 150 | 140 |
3.2. Clinical important datad Age, gender, outcomes: primary follow-up time; pain, disability, (primary outcomej: (APM/comparator) | 56 yrs., 61% males;
KOOS pain
e
56/62 (median), VAS
f
at physical activity 6/5 (median); Lysholm
g
61/73
| 59/58, 43% males; 6 months, WOMACh (OA scale) 37/38, KOOS pain 46/47 | 53 yrs., 61% males; Lysholmi 60/60; WOMETi56/53; Pain after exercise (NRSf) 5.8/6.1 | 57 yrs., 21% males;
Pain VAS
f
5.2/4.9;
Lysholm
i
64/65
| 54 yrs., 73% males;
KOOS pain 55/58
| 49/50 yrs., 61% males; 24 months; KOOS pain 68/63; Knee function 64/58, KOOS4 score 54/60 |
3.3. Health status/risk status | No | No | No | No | No | No |
3.4. Comorbidity | No | No | No | No | No | No |
3.5. Behaviour (e.g. lifestyle) | Yes (sports activity) | Yes (physical activity) | No | No | Yes (physical activity) | Yes (smoking) |
3.6. Environment (e.g. work conditions) | Yes (physical activity at work) | No | No | No | No | No |
3.7. Inequality (e.g. socioeconomic status) | No | No | No | No | No | Yes (education) |
4. Interventions | ||||||
4.1. Content of the arthroscopic partial meniscectomy APM + possible co-interventions (N randomised) | APM 44, debridement 14, (90, data of 47) + Exercises twice a week, 8 weeks | APM, removing loose fragments of cartilage (174, data of 161) | APM (70) | APM 54 (3 patients with additional proceduresk) + home exercise 8 weeks (54) | APM 56, other procedures 5, no procedures 8 + Unsupervised exercises (75) | APM (70) |
4.2.Content of the comparison intervention (N) | Exercises twice a week, 8 weeks (90, data of 43) | Exercises 1–2 times weekly, 6 weeks (177, data of 169) | Sham APM (75) | Supervised exercises, thrice weekly for 3 weeks. Home exercise, 8 weeks (54) | Unsupervised exercises 2 times weekly 12 weeks (75) | Exercises 2–3 times weekly, 12 weeks (70) |
4.3. Attendance in exercise therapy (%) | Unclear | 91% attended 8 visits | Not applicable | Unclear | Unclear | 43/70 (61%) at least satisfactory |
4.4. Failure to obtain surgery (%) | 0 (0%) | 9/174 (5%) at one year | 0 (0%) | 1/54 (2%) | 9 (12%) at one year | 6/70 (9%) |
4.5. Crossover to surgery (%) | 13/46 (28%) during 24 months | 59/177 (33%) at one year | Sham 5 (7%) (APM 2 (3%)) | 1/54 (2%) k | 16/75 (21%) | 13/70 (19%) |
4.6. Rehabilitation (additional) | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported |
4.7. Other use of health care services | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported |
4.8. Sickleaves | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported |
5. Outcomes | ||||||
5.1. Primary outcomes | 6 months: KOOSe;Lysholmg; Tegnerl; VASf | 12 months: WOMACh | 12 months: Lysholmg; WOMETi; Pain after exercise (NRSf) | 24 months: VASf; Lysholmg; Tegnerl; patient satisfaction | 12 months: KOOSe pain scale | KOOS4 (4/5 of KOOSe subscales); 3 months: thigh muscle strength |
5.2. Follow-up percentage; reasons for dropping out reported: Yes/No | Exerc:96% (47/49) APM: 96% (45/47) No | Physiotherapy: 93% (164/177) APM: 90% (156/174) Yes | Sham surgery: 100% (76/76) APM:100% (70/70) No drop-outs | Non-operative: 96% (52/54) APM: 93% (50/54) Yes | Exerc:93% (70/75) APM: 80% (60/75) No | Exerc: 89% (62/70) APM: 91% (64/70) No |
5.3. Outcomes assessed separately for disadvantaged patients (e.g. poor socioeconomic status) | No | No | No | No | No | No |