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Bhattacharya S, Middleton LJ, Tsourapas A, et al. ; the International Heavy Menstrual Bleeding Individual Patient Data Meta-analysis Collaborative Group Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis. Southampton (UK): NIHR Evaluation, Trials and Studies Coordinating Centre (UK); 2011 Apr. (Health Technology Assessment, No. 15.19.)

Appendix 3Quality of studies included in the systematic review of randomised trials comparing hysterectomy, endometrial destruction and Mirena for heavy menstrual bleeding

PaperWas randomisation adequate?Was the target population described adequately?Was the sample size calculation reported?Were the two populations comparable at baseline?Was an ITT analysis reported?Was the follow-up > 80%?Was compliance with allocated treatment > 80% in both arms at 12 months?
Hysterectomy vs first-generation EA
Dickersin et al., 200792YesYesYesYesYesYesYes
Zupi et al., 200378Unclear, not statedYesYesYesNoNoYes
Crosignani et al., 199745YesYesYesYesYesYesYes
O'Connor et al., 199744YesYesYesYesYesYesYes
Pinion et al., 199443Unclear, not statedNoYesYesYesYesNo
Dwyer et al., 199342Unclear, not statedYesYesYesNoYesYes
Gannon et al., 199141Unclear, not statedYesNoYesNoYesYes
Hysterectomy vs Mirena
Hurskainen et al., 200193YesYesYesYesYesYesNo
First- vs second-generation EA
Brun et al., 2006103YesYesYesYesNoNoYes
Cooper et al., 200499Unclear, not statedYesYesYesYesYesYes
Perino et al., 2004100Unclear, not statedYesYesYesYesYesYes
Duleba et al., 200398Unclear, not statedYesYesYesNoYesYes
Hawe et al., 200394YesYesYesYesYesYesYes
van Zon-Rabelink et al., 200495Unclear, not statedYesYesYesYesNoYes
Cooper et al., 200256Unclear, not statedYesYesYesYesYesYes
Pellicano et al., 2002102Unclear, not statedYesNoYesNoYesYes
Corson, 200179Unclear, not statedYesYesYesNoYesYes
Soysal et al., 200196YesYesNoYesNoYesYes
Corson et al., 2000101Unclear, not statedYesYesYesNoYesYes
Cooper et al., 199954YesYesYesYesYesYesYes
Meyer et al., 199853Unclear, not statedYesYesYesNoYesYes
Romer, 199897Unclear, not statedNoNoYesNoYesNo
Mirena vs first -generation EA
Malak et al., 2006104YesYesNoYesNoYesYes
Kittelsen, 1998105Unclear, not statedYesNoYesNoYesNo
Crosignani et al., 199780YesYesNoYesNoYesYes
Mirena vs second-generation EA
Shaw et al., 2007108YesYesYesYesNoNoNo
Tam et al., 2006109Unclear, not statedYesNoYesNoNoNo
Busfield et al., 2006107YesYesYesYesNoNoNo
Barrington et al., 200381Unclear, not statedYesNoNoNoYesYes
Soysal et al., 2002106YesYesYesYesYesYesYes
Time pointTrials (no.)WMD (95% CI)OR (95% CI)p-valueHetero (p)/I2 (%)
Duration surgery (minutes)6 (850)32 (30 to 34)< 0.0001< 0.0001/99
Duration hospital stay (days)7 (1066)3.0 (2.9 to 3.1)< 0.0001< 0.0001/99
Surgery pain score (0–10)2 (367)2.5 (2.2 to 2.9)< 0.00010.8/0
Return to work (days)6 (725)14 (13 to 16)< 0.0001< 0.0001/98
Return normal activities (days)5 (770)5.2 (4.7 to 5.7)< 0.0001< 0.0001/98
Return sexual activity (days)2 (302)36 (31 to 41)< 0.0001< 0.0001/99
Proportion dyspareunia6 months1 (166)0.71 (0.39 to 1.31)0.3
12 months2 (322)0.87 (0.51 to 1.48)0.60.2/47
SF-36 general health (absolute)12 months1 (181)−9.8 (−13.9 to −5.7)< 0.0001
SF-36 physical function (absolute)1 (181)−1.2 (−5.3 to 2.9)0.6
SF-36 role physical (absolute)1 (181)−0.8 (−5.0 to 3.4)0.7
SF-36 role emotional (absolute)1 (181)−3.9 (−8.2 to 0.4)0.08
SF-36 mental health (absolute)1 (181)−2.7 (−6.8 to 1.4)0.2
SF-36 social function (absolute)1 (181)−21.2 (−24.7 to −17.8)< 0.0001
SF-36 vitality (absolute)1 (181)−11.3 (−14.8 to −7.8)< 0.0001
SF-36 pain (absolute)1 (181)−1.5 (−6.1 to 3.1)0.5
SF-36 general health (absolute)2 years2 (225)−6.5 (−12.1 to −0.9)0.020.4/0
SF-36 physical function (absolute)2 (221)−2.8 (−7.4 to 1.8)0.20.8/0
SF-36 role physical (absolute)2 (223)−1.3 (−10.4 to 7.9)0.80.4/0
SF-36 role emotional (absolute)2 (224)−7.6 (−16.2 to 1.1)0.090.7/0
SF-36 mental health (absolute)2 (221)−2.8 (−7.4 to 1.8)0.20.6/0
SF-36 social function (absolute)2 (221)−7.1 (−12.5 to −1.8)0.0090.5/0
SF-36 vitality (absolute)2 (222)−5.0 (−10.5 to 0.5)0.070.08/67
SF-36 pain (absolute)2 (225)−8.4 (−14.9 to −2.0)0.010.6/0
SF-36 general health (change)12 months1 (181)−9.6 (−13.5 to −5.7)< 0.0001
SF-36 physical function (change)1 (181)−1.0 (−5.0 to 3.0)0.6
SF-36 role physical (change)1 (181)0.1 (−4.1 to 4.3)1.0
SF-36 role emotional (change)1 (181)−4.4 (−8.4 to −0.4)0.03
SF-36 mental health (change)1 (181)−1.0 (−4.9 to 2.9)0.6
SF-36 social function (change)1 (181)−24 (−27 to −21)< 0.0001
SF-36 vitality (change)1 (181)−13 (−16 to −9)< 0.0001
SF-36 pain (change)1 (181)−2.2 (−7.3 to 2.9)0.4
EQ-5D (absolute)6 months1 (220)−0.09 (−0.16 to −0.02)0.02
12 months1 (210)0.00 (−0.08 to 0.08)1.0
2 years1 (213)−0.02 (−0.09 to 0.05)0.6
3 years1 (157)0.04 (−0.05 to 0.13)0.4
4 years1 (98)−0.01 (−0.12 to 0.10)0.9
EQ-5D (change)6 months1 (220)−0.09 (−0.18 to −0.00)0.05
12 months1 (210)−0.03 (−0.13 to 0.07)0.5
2 years1 (213)−0.03 (−0.12 to 0.06)0.5
3 years1 (157)0.06 (−0.05 to 0.17)0.3
4 years1 (96)−0.01 (−0.16 to 0.14)0.9
TrialsFrequency
Repeat EA6 months311/318 (3%)
12 months317/248 (7%)
2 years213/222 (6%)
3 years215/189 (8%)
4 years11/48 (2%)
5 years12/123 (2%)
Hysterectomy after EA6 months311/305 (4%)
12 months427/271 (10%)
2 years338/246 (15%)
3 years233/194 (17%)
4 years123/59 (39%)
5 years142/123 (34%)
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Cover of Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis
Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis.
Health Technology Assessment, No. 15.19.
Bhattacharya S, Middleton LJ, Tsourapas A, et al. ; the International Heavy Menstrual Bleeding Individual Patient Data Meta-analysis Collaborative Group

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