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. 2013 Jul 5;2:52. doi: 10.1186/2046-4053-2-52

Table 1.

Characteristics of the 22 identified surgical IPDMAs

Author and year RCTs ( n ) Patients ( n ) Patients Intervention Comparison Outcome Subgroups ( n ) Overall effect estimate Significant effect estimates in subgroups ( n / N )
Jorgenson et al., 2007 [19]
7
2,091
Women with cervical insufficiency
Cervical cerclage
Expectant management, no cerclage
Primary
Obstetric history, cervical length (2)
NS
0/2
Pregnancy loss or neonatal death before discharge from hospital
Secondary
Preterm delivery and maternal morbidity
Hlatky et al., 2009 [20]
10
7,812
Patients with multivessel coronary disease
Coronary artery bypass graft
Percutaneous coronary intervention
All-cause mortality
Age, sex, diabetes, smoking, hypertension, hypercholesterolaemia, PVD, stability of symptoms, previous MI, heart failure, LV function, no. of diseased vessel, proximal LAD, balloon vs.stent (14)
NS
2/14
Daniels et al., 2010 [21]
5
862
Patients with chronic pelvic pain
Laparoscopic uterosacral nerve ablation (LUNA)
No LUNA
Derived measure of worst pain level experienced
Presence of visual pathology, site of pain, age, parity (4)
NS
1/4
Burzotta et al., 2009 [22]
11
2,686
Patients with ST-elevation myocardial infarction (STEMI)
Percutaneous coronary intervention with thrombectomy
Standard percutaneous coronary intervention
Primary
Manual vs. non-manual thrombectomy devices, diabetes, primary vs. rescue PCI, treated vs. non-treated with IIb/IIIa-inhibitors, ischemic time, infarct-related artery, pre-PCI TIMI flow (7)
S
1/7
All-cause mortality
Secondary
Survival free from MI, TLR, or TVR, major adverse coronary events (MACE), death+MI
Carotid Stenting Trialists’Collaboration, 2010 [23]
3
3,433
Patients with symptomatic carotid stenosis
Carotid stenting
Endarterectomy
Primary
Age, sex, diabetes, hypertension, SBP, hypercholesterolaemia, smoking, coronary heart disease, peripheral artery disease, most recent ipsilateral ischemic event, history of stroke, degree of ipsilateral ischemic stroke, contralateral severe carotid stenosis or occlusion, treatment within 14 days, patients recruited per center, center recruitment rate (16)
S
1/16
Any stroke or death
Secondary
Disabling stroke or death, all-cause death, any stroke, myocardial infarction, severe local hematoma, severe wound infection
Middleton et al., 2010 [24]
17
2,814
Patients with heavy menstrual bleeding
Hysterectomy, endometrial destruction (1st & 2nd generation), levonorgestrel releasing intra-uterine system (MIRENA)
Endometrial destruction (1st & 2nd generation), levonorgestrel releasing intra-uterine system (MIRENA)
Dissatisfaction rates
Uterine cavity length, age, presence of fibroids/polyps, parity, baseline bleeding score (5)
S
1/5
Mercado et al., 2005 [25]
4
3,051
Patients with multi-system coronary artery disease
Percutaneous coronary intervention with multiple stenting
Coronary artery bypass graft
Primary
Age, gender, diabetes, smoking, number of diseased vessels (5)
NS
0/5
Composite of death, MI, or stroke at 1 year FU
Secondary
Death, composite of death or MI, repeat revascularization, composite of death, MI, stroke, and repeat revalscularization
Boersma et al., 2006 [26]
22
6,767
Patients with acute myocardial infarction
PCI
Fibrinolysis
All-cause mortality
Age, sex, diabetes, prior MI, MI location, heart rate, SBP, fibrinolytic agent, front-loaded tPA, site volume (11)
S
1/11
Timmer et al., 2007 [27]
19
6,315
Patients with acute myocardial infarction
PCI
Fibrinolysis
Death, recurrent MI, death or recurrent MI, stroke
Diabetes (1)
S
0/1
de Boer et al., 2010 [28]
22
6,767
Patients with acute myocardial infarction
Primary PCI
Fibrinolysis
Primary
Age (1)
S
0/1
All-cause mortality
Secondary reMI, stroke, composite of all-cause mortality or reMI, composite of all-cause mortality, reMI, or stroke
de Boer et al., 2011 [29]
22
6,767
Patients with acute myocardial infarction
Primary PCI
Fibrinolysis
All-cause mortality
High-risk patients (1)
S
0/1
Fox et al., 2010 [30]
3
5,467
Patients with non-ST-elevation myocardial infarction
Routine invasive strategy
Selective invasive strategy
Primary
High-risk groups based on baseline characteristics (1)
S
1/1
Composite of CV death or non-fatal MI
Secondary
All-cause death, non-fatal MI alone
Damman et al., 2012 [31]
3
5,467
Patients with non-ST-elevation myocardial infarction
Routine invasive strategy
Selective invasive strategy
Primary
Age (1)
S
1/1
Composite of CV death or non-fatal MI, CV death, MI
Damman et al., 2012 [32]
3
5,467
Patients with non-ST-elevation myocardial infarction
Routine invasive strategy
Selective invasive strategy
All-cause mortality
Procedure-related MI, spontaneous MI (2)
S
1/2
Biau et al., 2009 [33]
6
423
Patients with symptomatic unilateral anterior cruciate ligament injury
Reconstruction with patellar tendon autograft
Reconstruction with hamstring tendon autograft
Primary
Gender, age at surgery, trial effect (3)
S
2/3
Positive pivot-shift test Secondary
Positive Lachman test
Rovers et al., 2005 [34]
7
1,234
Children with otitis media with effusion
Short-term ventilation tubes
Watchful waiting
Mean time spent with effusion, hearing, language development
Hearing level at baseline, history of acute otitis media, upper respiratory infections, attending day care, socioeconomic status, siblings, season, history of breastfeeding, parental smoking (9)
NS
2/9
Salerno et al., 2007 [35]
4
305
Cirrhotic patients with refractory ascites
Transjugular intrahepatic portosystemic shunt (TIPS)
Paracentesis
Primary
NA
S
NA
Death from any cause before LT
Secondary
Liver-related death
Staples et al., 2011 [36]
2
209
Patients with osteoporotic vertebral compression fractures
Vertebroplasty
Sham
Scores for pain and function
Onset of pain, pain scores at baseline (2)
NS
0/2
McCormack et al., 2003 [37]
25
4,165
Patients with clinical diagnosis of groin hernia for whom surgical management was judged appropriate
Laparoscopic repair
Open repair
Duration of operation, ‘opposite’ method initiated, conversion, hematoma, seroma, wound/superficial infection, mesh/deep infection, port site hernia, vascular injury, visceral injury, length of hospital stay, time to return to usual activities, persisting pain, persisting numbness, hernia recurrence, known death within 30 days of surgery
NA
S
NA
(Transabdominal preperitoneal repair (TAPP) or totally extraperitoneal repair (TEP))
Scott et al., 2002 [38]
11
3,347
Patients with clinical diagnosis of groin hernia for whom surgical management was judged appropriate
Mesh technique
Non-mesh technique
Duration of operation, ’opposite’ method initiated, conversion, hematoma, seroma, wound/superficial infection, serious complications, length of postoperative hospital stay, time to return to usual activities, persisting pain, persisting numbness, hernia recurrence, known death
NA
S
NA
EU Hernia Trialists Collaboration, 2002 [39]
35
6,901
Patients with clinical diagnosis of groin hernia for whom surgical management was judged appropriate
Laparoscopic repair, mesh methods
Open repair, non-mesh methods
Hernia recurrence, persisting pain
NA
S
NA
Gregson et al., 2012 [40] 8 2,186 Patients with spontaneous supratentorial intracerebral hemorrhage Surgery Conservative treatment Unfavorable outcome Location of hematoma, time from event, age, Glascow Coma Score, volume of hematoma (5) NA 4/5