Bilaga till rapport. Bilaga 6 Tabellverk över ingående studier Appendix 6 Included articles. Table of Contents 1 (169)

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Bilaga till rapport Endometrios diagnostik, behandling och bemötande / Endometriosis diagnosis, treatment and patients experiences, rapport 277 (218) 1 (169) Bilaga 6 Tabellverk över ingående studier Appendix

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Bilaga till rapport Endometrios diagnostik, behandling och bemötande / Endometriosis diagnosis, treatment and patients experiences, rapport 277 (218) 1 (169) Bilaga 6 Tabellverk över ingående studier Appendix 6 Included articles Table of Contents Included diagnostic studies in alphabetic order... 2 s studies except for surgery Laparoscopy, alphabetic order Cohort studies, Deep infiltrating endometriosis and Surgery Included qualitative studies, alphabetic order SBU Statens beredning för medicinsk och social utvärdering Telefon Fax Organisationsnummer Besöksadress S:t Eriksgatan 117, Stockholm Postadress Box 6183, Stockholm 2 (169) Included diagnostic studies in alphabetic order Abrao et al 27 Brazil [1] Bazot 21 France [3] ; recruitment Target condition ; recruitment Cross-sectional; consecutive enrolment Target condition Posterior DIE (rectosigmoid and retro-cervical area) - separate anatomical sites Tertiary university hospital, referral centre for endometriosis ; recruitment Prospective; consecutive enrolment Target condition Adenomyosis Hospital No included in both tests 1 Clinical presentation Prevalence n=14 Patients with clinically suspected endometriosis Mean age, years: 33.8±6.1, range No included in both tests 14/14 Clinical presentation Dysmenorrhoea 53/14 Deep dyspareunia 66/14 Acyclical pelvic pain 17/14 Infertility 55/14 Cyclical bowel symptoms (pain/bleeding) 59/14, cyclical urinary symptoms14/14 Prevalence Pelvic endometriosis: 98/14 (91%), DIE: 63/14 (61%) n=12 Patients referred for hysterectomy Mean age, years: 51, range 3 88 No included in both tests 12/12 Symptoms/indications for surgery Index test(s) standard(s) Examiners Index test Transvaginal ultrasound, TVS Pelvic MRI 1.5 Tesla, (T1/T2- weighted, gadolinium, gel in vagina) standard Laparoscopy/laparoscopic surgery + histopathology Examiners TVS: one examiner; level of expertise unclear MRI-reader: one radiologist blinded to clinical data and to results of other imaging tests, level of expertise not reported test: Not clearly reported ( results of surgery ) Index test Transvaginal ultrasonography, TVS standard Gross and microscopic histopathological examinations Examiners Index test: examinations were interpreted blindly to histopathological findings. Results Sensitivity Specificity PPV, NPV TVS Rectosigmoid Sensitivity: 98% Specificity: 1% PPV: 1%, NPV: 98% Retrocervical Sensitivity: 95% Specificity: 98% PPV. 98%, NPV:97% MRI Rectosigmoid Sensitivity: 83% Specificity: 98% PPV: 98%, NPV: 84% Retrocervical Sensitivity: 76% Specificity: 68% PPV: 61%, NPV: 81% Adenomyosis TVS 1 Sensitivity 6% Specificity 99% TVS 2 Sensitivity 38% Specificity 99% TVS 3 Sensitivity 52% Specificity 9% TVS 4 Sensitivity 3% Possible overlap of MRI data with Chamie 29 [2] (study period November 25 to July 27) Sonography diagnostic criteria for adenomyosis: TVS 1: myometrial cyst TVS 2: focal abnormal myometrial echotexture TVS 3: distorted heterogeneous 1 Number of persons in the study that were included in both test the index test and reference test 3 (169) ; recruitment Target condition No included in both tests 1 Clinical presentation Prevalence Menorrhagia and/or metrorrhagia 61/12 Post-menopausal bleeding 17/12 Adnexal masses 15/12 Cervical intraepithelial neoplasia 12/12 Pelvic pain 16/12 Genital prolapse 11/12 Premenopausal 69% Postmenopausal 31% Index test(s) standard(s) Examiners standard: Histopathological examinations were all performed by the same pathologist, who was blinded to sonographic Results Sensitivity Specificity PPV, NPV Specificity 96% TVS 5 Sensitivity 65% Specificity 98% myometrial echotexture TVS 4: globular uterine configuration TVS 5: criteria TVS 1 and 2 Bazot et al 29 France [4] ; recruitment Longitudinal; consecutive enrolment Target condition DIE: separate anatomical sites; ovarian endometriosis Tertiary care, referral centre for endometriosis and Surgical Centre Prevalence Adenomyosis 33% n=92 Women referred with clinical evidence of pelvic endometriosis Median age, years: 31.8, range 2 5 No included in both tests 92/92 Clinical presentation Dysmenorrhoea 79/92, Dyspareunia 63/92 Dyschezia 32/92 Dysuria 3/92 Infertility 21/92 History of surgery for endometriosis 31/92 Prevalence DIE 9/92 (97.8%) Ovarian endometriosis 36/92 (39.1%) Index test Transvaginal ultrasound, TVS Rectal endoscopic sonography (RES) MRI 1.5 Tesla (T1/T2- weighted +/- fatsupression/gadolinium contrast) Examiners All techniques interpreted independently and blindly by different physicians TVS: 1 radiologist with extensive experience in gynaecological imaging. Blinded test: Not reported. RES: real time by the same gastroenterologist with 5 years experience in endometriosis. MRI: according to a standardised protocol, retrospectively by 1 radiologist TVS Uterosacral ligaments Sensitivity: 78% Specificity: 67% Rectosigmoid Sensitivity:94% Specificity:1% Vagina Sensitivity: 47% Specificity: 95% Rectovaginal septum Sensitivity: 9% Specificity: 99% Endometrioma Sensitivity: 95% Specificity: 84% RES Uterosacral ligaments Sensitivity: 48% Specificity: 44% Rectosigmoid Sensitivity: 89% Specificity: 93% Vagina Unclear if exclusion criteria were correct Readers informed of women s clinical history and symptoms, blinded to results of physical and previous imaging examinations. 4 (169) ; recruitment Target condition No included in both tests 1 Clinical presentation Prevalence Index test(s) standard(s) Examiners with 2 years experience in gynaecological imaging. test: not clearly reported (histology in all but 2 cases; surgery in 2 cases) Results Sensitivity Specificity PPV, NPV Sensitivity: 7% Specificity: 1% Rectovaginal septum Sensitivity: 18% Specificity: 95% Endometrioma Sensitivity: 65% Specificity: 93% MRI Uterosacral ligaments Sensitivity: 84% Specificity: 89% PPV:99%, NPV:38% Rectosigmoid Sensitivity: 87% Specificity: 93% PPV: 97%, NPV: 77% Vagina Sensitivity: 8% Specificity: 86% PPV: 73%, NPV: 9% Rectovaginal septum Sensitivity: 54% Specificity: 99% PPV: 5%, NPV: 89% Endometrioma Sensitivity: 92% Specificity: 88% Rectal endoscopic US Uterosacral ligaments Sensitivity:48% Specificity:44% PPV: 89%, NPV: 9% Accuracy: 47.8% Rectosigmoid Sensitivity:88.9% Specificity:93.1% 5 (169) Bergamini et al 21 Italy [5] ; recruitment Target condition ; recruitment Prospective, multi-centre, observational; consecutive enrolment Target condition Posterior DIE/ rectosigmoid endometriosis University Hospitals of Verona and Varese, referral centres for endometriosis treatment No included in both tests 1 Clinical presentation Prevalence n=61 women scheduled for surgery because of signs and symptoms of severe posterior DIE Mean age years: 33.1, range No included in both tests 61/61 Clinical presentation Dyspareunia / catamenial rectal pain 61/61 History of intermittent bowel obstruction 4/61 Nulliparous 11/61, History of surgery for endometriosis 19/61 Prevalence Pelvic endometriosis 58/61 (95%) Rectosigmoid endometriosis 51/61 (84%) Index test(s) standard(s) Examiners Index test Rectal-Water-Contrast transvaginal ultrasound, RWC-TVS Transrectal Sonography (TRS) standard Laparoscopy Examiners All scans performed by the same operator with extensive experience in ultrasonographic diagnosis of endometriosis. Operator blinded with respect to other diagnostic findings; unclear whether operator was aware of the results of an additional index test (same operator, different test times) Results Sensitivity Specificity PPV, NPV PPV: 97%, NPV:79% Accuracy: 9.2% Vagina Sensitivity: 7% Specificity: 1% PPV: 1%, NPV: 69% Rectovaginal septum Sensitivity: 18% Specificity: 95% PPV: 33%, NPV: 9% TRS Rectosigmoid Sensitivity: 88% Specificity: 8% RWC-TVS Rectosigmoid Sensitivity: 96% Specificity: 89% 6 (169) Biscaldi et al 27 Italy [6] ; recruitment Target condition ; recruitment Prospective, observational, unclear enrolment Target condition Bowel endometriosis/ rectosigmoid Tertiary care university hospital No included in both tests 1 Clinical presentation Prevalence n=98 Women with typical symptoms caused by pelvic endometriosis and gastrointestinal symptoms suggestive of colorectal endometriosis Median age, years: 34, range 2 to 53 No included in both tests 98/98 Clinical presentation Dysmenorrhoea 87/98 Dyspareunia 73/98 Chronic pelvic pain 48/98 Infertility 23/98 Diarrhoea 2/98 Constipation 12/98 Bloating 5/98 Previous surgery for endometriosis 37/98 Previous medical treatment: oral contraceptive pill 81/98 GnRH-analogues 4/98 Norethisterone acetate 7/98 Letrozole 2/98 No patients with previous bowel surgery other than appendicectomy Index test(s) standard(s) Examiners Index test MDCT-e (MSCTe) (CTenterography) standard Laparoscopy/laparscopic surgery 98/98 (1%) + histopathology Examiners Index test: independently reviewed by 2 observers; level of expertise not reported; radiologists not aware of clinical findings and patient history, knowing only that bowel endometriosis was suspected test: a team of gynaecological and colorectal surgeons with extensive experience in the treatment of bowel endometriosis; unclear whether blinded to results of index test; Level of competence of pathologists not described; histological examination described Results Sensitivity Specificity PPV, NPV Sensitivity: 99% Specificity: 1% Index test compared to reference test also regarding size, localization and degree of bowel wall infiltration. Unclear if lesions involving only the bowel serosa are included Prevalence Bowel endometriosis 76/98 (77.5%) 7 (169) Biscaldi et al 214 Italy [7] Chamie et al 29 Italy [2] ; recruitment Target condition ; recruitment Prospective, observational, unclear enrolment Target condition Rectosigmoid endometriosis Tertiary care university hospital, San Martino Hospital, referral centre for endometriosis. ; recruitment Prospective, crosssectional; unclear enrolment Target condition DIE - separate anatomical sites No included in both tests 1 Clinical presentation Prevalence n= 26 patients referred to (our) endometriosis centre Mean age, years: 32.6±4.3 No included in both tests 26/26 Clinical presentation Dysmenorrhoea 185/26 Dyspareunia 157/26 Chronic pelvic pain 142/26 Infertility 54/26 Diarrhoea 57/26 Constipation 85/26 Bloating 122/26 Dyschezia 13/26 Previous surgery for endometriosis 113/26 Previous medical treatment: oral contraceptive pill 79/26 Contraceptive vaginal ring 14/26 Prevalence Bowel endometriosis 176/26 (68 %) n=92 Women who had a history and findings of a physical exam consistent with endometriosis Mean age, years: 33, range 2 52 No included in both tests 92/92 Index test(s) standard(s) Examiners Index test MDCT-e (CT-enterography) MRI-enema 1.5 T (T1/T2 weighted, +/- fat suppression, gadolinium contrast) standard Laparoscopy 26/26 (1%) + histopathology Examiners Index test: 2 radiologists blindly reviewed images at a workstation; not aware of clinical findings and patient history, knowing only that the presence of bowel endometriosis was clinically suspected; level of expertise not reported test: team of gynaecological and colorectal surgeons with extensive experience in the treatment of bowel endometriosis; surgeons aware of results of index tests; level of competence of pathologists not described; histological examination not described Index test MRI 1.5 T (T1/T2-weighted +/- fat suppression/ Gadolinium contrast) standard Laparoscopy 92/92 (1%) + histopathology Results Sensitivity Specificity PPV, NPV MDCT-e Rectosigmoid Sensitivity: 98% Specificity: 99% MRI Rectosigmoid Sensitivity: 97% Specificity: 96% Retrocervical Sensitivity: 89% Specificity: 92% Rectosigmoid Sensitivity: 86% Specificity: 93% Bladder Sensitivity: 23% Specificity: 1% Index test compared to reference test also regarding size of endometriotic nodules Lesions involving only the bowel serosa are probably not included (unclear) 8 (169) Dessole et al 23 Italy [8] ; recruitment Target condition Tertiary university hospital, referral centre for endometriosis ; recruitment Prospective, observational; unclear enrolment Target condition Posterior DIE (rectovaginal endometriosis) University Hospital No included in both tests 1 Clinical presentation Prevalence Clinical presentation Dysmenorrhoea 89/92 Dyspareunia 54/92, Acyclical pain 72/92 Dysuria 8/92 Dyschezia 44/92 Infertility 4/92 Painful palpable nodules on examination 58/92 Prevalence Pelvic endometriosis 92/92 (1%) DIE 77/92 (83.7%) n=46 Women scheduled for laparotomy or laparoscopy because rectovaginal endometriosis was suspected based on patient history and clinical examination Mean age, years: 3.3±4.2 No included in both tests 46/46 Clinical presentation Chronic pelvic pain, dysmenorrhoea or dyspareunia 38/46 Infertility 2/46 Gastrointestinal disorders 7/46 Urinary disorders 6/46 Endometriotic lesion detected on gynaecological examination 8/46 Index test(s) standard(s) Examiners Examiners MRI: images analysed prospectively by 2 radiologists (consensus agreement), blinded to each patient s history, physical findings and ultrasound results; level of expertise not reported. test: numbers or level of expertise of surgeons or pathologists not reported; unclear whether blinded to results of index test. Index test Transvaginal ultrasound, TVS Sonovaginography, SVG standard Laparoscopy 2/46 (43.5%) Laparotomy 26/46 (56.5%) + histopathology Examiners Index test: numbers of examiners, level of expertise and blinding to clinical data not reported test: numbers or level of expertise of surgeons or pathologists not reported; no blinding to results of index test Results Sensitivity Specificity PPV, NPV Ureteral Sensitivity: 5% Specificity: 1% Vagina Sensitivity: 73% Specificity: 1% Rectovaginal TVS Sensitivity: 44% Specificity: 5% SVG Sensitivity: 91% Specificity: 86% 9 (169) ; recruitment Target condition No included in both tests 1 Clinical presentation Prevalence No patients had undergone surgical pelvic procedure before entering the study Index test(s) standard(s) Examiners Results Sensitivity Specificity PPV, NPV Dueholm 21 Denmark [9] ; recruitment Prospective, consecutive enrolment Target condition Adenomyosis Prevalence Pelvic endometriosis 4/46 (87%) Rectovaginal endometriosis 32/46 (69.5%) Peritoneal endometriosis 8/46 (17.4%) n=16 Premenopausal patients undergoing hysterectomy for benign disease Mean age, years: 44.7±5.2, range Index test Transvaginal ultrasound, TVS MRI 1.5T, T2 weighted standard Histopathologic examination TVS Sensitivity 59% Specificity 79% MRI Sensitivity: 64% Specificity: 88% Indefinite findings included as negative University medical school No included in both tests 16/16 Symptoms: Abnormal uterine bleeding 51/16 Symptomatic myomas 35/16 Lower abdominal pain or endometriosis 17/16 Dysplasia or prior borderline ovarian tumor 3/16 Abnormal bleeding 82/16 Prevalence Adenomyosis 22/16 (22%) Examiners All hysterectomy specimens were examined by a single Pathologist (level of experience not reported), all MRI scans were evaluated by a single MRI specialist (level of experience not reported), and TVS was always performed by the same experienced gynaecologist (level of experience not reported). MRI, TVS, and pathologic examinations were performed independently and without knowledge of the other investigators findings and the findings were evaluated consecutively. MRI + TVS Sensitivity 73% Specificity 75% 1 (169) Exacoustos 211 Italy [1] Ferrero et al 211 Italy [11] ; recruitment Target condition ; recruitment Prospective, consecutive enrolment Target condition Adenomyosis University hospital ; recruitment Prospective, observational; unclear Enrolment Target condition Bowel and rectosigmoid endometriosis Single centre, University Hospital No included in both tests 1 Clinical presentation Prevalence n=72 Premenopausal patients scheduled for hysterectomy Mean age, years: 46.7, range No included in both tests 72/72 Symptoms/indications for surgery: Benign pelvic pathology: Menorrhagia or abnormal uterine bleeding 55/72 (76%) Uterine prolapse 7/72 (1%) Ovarian pathology 1/72 (14%) Prevalence Adenomyosis 44.4% n=96 Patients referred to the endometriosis centre, suspicion of deep pelvic endometriosis mean age: 33.4±5.2 years No included in both tests 96/96 Clinical presentation Dysmenorrhoea 72/96 Deep dyspareunia 49/96 Chronic pelvic pain 61/96 Dyschezia 39/96 Infertility 32/96 Diarrhoea 28/96 Constipation 39/96 Intestinal cramping 4/96 Abdominal bloating 53/96 Mucus in the stools 13/96 Index test(s) standard(s) Examiners Index test 2D & 3D transvaginal ultrasound, TVS standard Histopathologic examination after hysterectomy Examiners TVS: Each scan (2D and 3D) was performed by one of three expert sonographers. All 2D and 3D ultrasound evaluations and measurements were done during the same examination period and by the same operator. Histopathological examination: performed by a single pathologist, who was blinded to the sonographic data Index test Rectal-Water-Contrast transvaginal sonography, RWC-TVS MDCT-e (CT-enterography) standard Laparoscopy 96/96 (1%) + histopathology Examiners Index test: independently and blindly performed by different investigators, blinded to the clinical data, level of expertise not reported. test: team of gynaecological and colorectal surgeons with extensive experience in the treatment of Results Sensitivity Specificity PPV, NPV Adenomyosis 2D-TVS Sensitivity 75% Specificity 9% 3D-TVS Sensitivity 91% Specificity 88% RWC-TVS Rectosigmoid Sensitivity: 94% Specificity: 98% Bowel endometriosis Sensitivity: 88% Specificity: 98% CT Rectosigmoid Sensitivity: 96% Specificity: 1.% Bowel endometriosis Sensitivity: 96% Specificity: 1% CT-enterography was associated with more intense pain than Rectal Water Contrast transvaginal sonography Index test compared to reference test also regarding size and number of endometriotic nodules For rectosigmoid it is unclear if lesions involving only the bowel serosa are included; for bowel 11 (169) ; recruitment Target condition No included in both tests 1 Clinical presentation Prevalence Rectal bleeding 2/96 Previous live birth 27/96 Previous surgery for endometriosis 39/96 Hormonal therapy at time of study 34/96 Index test(s) standard(s) Examiners pelvic and bowel endometriosis, aware of index test results. The same pathologist histologically evaluated all biopsies, level of expertise not reported. Results Sensitivity Specificity PPV, NPV endometriosis serosal lesions are not included Ferrero 217 Italy [12] ; recruitment Prospective observational Target condition Intestinal endometriosis Single centre, University Hospital Prevalence Pelvic endometriosis 96/96 (1%) Bowel endometriosis 51/96 (53.1%) Rectosigmoid endometriosis 48/96 (5%) n=7 Women scheduled for laparoscopy with strong suspicion of intestinal endometriosis Mean age, years 35.7±5.1 No included in both tests 7/7 Clinical presentation Dysmenorrhea 64/7 (91 %) Non-menstrual pelvic pain 55/7 (79 %) Dyspareunia 52/7 (74 %) Dyschezia 44/7 (63 %) Persistent constipation 25/7 (36 %) Constipation during menstruation 14/7 (2%) Diarrhea 2/7 (29 %) Diarrhea during menstruation 22/7 (31 %) Intestinal cramping 4 (57 %) Abdominal bloating 43 (61 %) Index test Rectal-Water-Contrast transvaginal sonography, RWC-TVS Computed tomographic colonography (CTC) standard Laparoscopy 7/7 (1%) + histopathology Examiners Index test: TVS: A sonographer with extensive experience in the diagnosis of intestinal endometriosis ( 5 scans) performed all the examinations. CTC: A radiologist with more than 5 years experience in virtual colonoscopy scans ( 5 cases) and in the diagnosis of intestinal endometriosis monitored each RWC-TVS Rectosigmoid RWC-TVS Rectosigmoid Sensitivity 93% Specificity 97% CTC Rectosigmoid Sensitivity 93% Specificity 87% 12 (169) Goncalves et al 21 Brazil [13] ; recruitment Target condition ; recruitment Prospective observational; consecutive enrolment Target condition Recto-sigmoid endometriosis 2 University Hospitals No included in both tests
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