WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections: web annex 3: GRADE evidence tables

WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections The guideline recommendations are available at http://www.who.int/reproductivehealth Web annex 3: GRADE evidence tables WHO/RHR/18.22 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections. Web annex 3: GRADE evidence tables. Geneva: World Health Organization; 2018 (WHO/RHR/18.23). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see Http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. This publication forms part of the WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections. It is being made publicly available as supplied by those responsible for its development for transparency purposes and information, as required by WHO (see the WHO handbook for guideline development, 2nd edition (2014). WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 2 Web annex 3 GRADE evidence tables TABLE 1. EFFECTS OF INTERVENTIONS TARGETED AT WOMEN STUDY QUALITY ASSESSMENT OUTCOME INTERVENTION CONTROL EFFECT (95% CI) OR P-VALUE CERTAINTY (GRADE)* DESIGN RISK OF BIAS INCONSISTENCY INDIRECTNESS IMPRECISION OTHER ASPECTS Masoumi et al (2016) Antenatal education programme on physiological childbirth (birth preparation training) RCT Not serious Single study Not serious Seriousa None CS 33/75 (44%) 32/75 (43.7%) RR 1.03 (0.72 to 1.49) MODERATEa Physiological birth 6/75 (8%) 0/75 (0%) Not estimable Normal vaginal birth 36/75 (48%) 43/75 (57%) RR 0.84 (0.62 to 1.14) Feinberg et al (2015) Psychosocial couple-based prevention programme RCT Seriousb Single study Not serious Seriousa None CS 21% (n = 76) (number of events unclear) 40% (n = 71) (number of events unclear) OR 0.36 (0.15 to 0.86) LOW a, b Maternity length of stay (days) (mean, SD) 3.11 ± 2.09 (n = 76) 3.36 ± 2.50 (n = 71) MD -0.25 (-1.00 to 0.50) Newborn length of stay (days) (mean, SD) 2.67 ± 1.04 (n = 76) 2.89 ± 1.17 (n = 71) MD -0.22 (-0.58 to 0.14) WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 3 Web annex 3 GRADE evidence tables Fenwick et al (2015) Psycho- education by telephone RCT Seriousb Single study Seriousc Seriousa None Overall CS 31/91 (34.1%) 39/93 (41.9%) RR 0.81 (0.56 to 1.18) VERY LOW a, b, c Emergency CS 16/91 (17.6%) 23/91 (24.7%) RR 0.70 (0.39 to 1.23) SVD 44/91 (48.4%) 39/93 (41.9%) RR 1.15 (0.84 to 1.59) Forceps and vacuum delivery 16/91 (17.6%) 15/93 (16.1%) RR 1.09 (0.57 to 2.07) Nursery admission 16/91 (17.6%) 18/91 (19.4%) RR 0.89 (0.48 to 1.63) Maternal readmission 3/91 (3.3%) 5/91 (5.4%) RR 0.60 (0.15 to 2.44) Baby readmission 8/91 (8.8%) 6/91 (6.5%) RR 1.33 (0.48 to 3.69) Breastfeeding at six months 76/91 (83.5%) 73/91 (78.5%) RR 1.04 (0.91 to 1.19) Satisfaction with mode of birth 53/91 (58.2%) 61/91 (65.6%) RR 0.87 (0.69 to 1.09) Wang, Li & Deng (2014) Pelvic floor muscle training exercises (PFMT) with telephone follow up RCT Seriousb Single study Not serious Seriousa None Overall CS 16/35 (31.4%) 27/55 (49.1%) RR 0.87 (0.37 to 2.04) LOW a, b Episiotomy 47.1% (number of events/ participants unclear) 47.3% (number of events/participants unclear) P=0.35 Perineal laceration 7.8% (number of events/ participants unclear) 3.6% (number of events/ participants unclear) P=0.98 WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 4 Web annex 3 GRADE evidence tables Valiani, Haghighatdana & Ehsanpour (2014) Childbirth training workshop RCT Seriousb Single study Not serious Seriousa None Mothers alone vs control: CS 12/30 (40%) 22/30 (73.3%) RR 0.55 (0.33 to 0.89) LOW a, b Couple vs control: CS 13/30 (43.3%) 22/30 (73.3%) RR 0.59 (0.37 to 0.94) Mothers alone vs control: vaginal delivery 18/30 (60%) 8/30 (26.7%) RR 2.25 (1.16 to 4.36) Couple vs control: vaginal delivery 17/30 (56.7%) 8/30 (26.7%) RR 2.13 (1.09 to 4.16) Rouhe et al (2013) Psycho- education RCT Seriousb Single study Not serious Seriousa None Overall CS 30/131 (22.9%) 78/240 (32.5%) RR 0.70 (0.49 to 1.01) LOW a, b Elective CS 14/131 (10.1%) 31/240 (12.9%) RR 0.83 (0.46 to 1.50) Emergency CS 16/131 (12.2%) 47/240 (19.6%) RR 0.62 (0.37 to 1.06) SVD 83/131 (63.4%) 114/240 (47.5%) RR 1.33 (1.11 to 1.61) Positive delivery experience, >75th percentile of the DSS 30/77 (36.1%) 31/124 (22.8%) RR 1.56 (1.03 to 2.36) Sharifirad et al (2013) Prenatal education for husbands RCT Seriousb Single study Seriousc Seriousa None CS 29.5% (n = 44) (number of events unclear) 50.0% (n = 44) (number of events unclear) P < 0.05 VERY LOW a, b, c WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 5 Web annex 3 GRADE evidence tables Bergström, Kieler & Waldenström (2009) Antenatal education on natural childbirth preparation with training in breathing and relaxation techniques RCT Not serious Single study Not serious Seriousd None Elective CS 29/484 (6.0%) 31/493 (6.3%) RR 0.95 (0.58 to 1.56) MODERATEd Emergency CS 67/484 (13.8%) 75/493 (15.2%) RR 0.91 (0.67 to 1.23) SVD 321/484 (66.3%) 327/493 (66.3%) RR 1.00 (0.91 to 1.09) Instrumental delivery 67/484 (13.8%) 60/493 (12.2%) RR 1.14 (0.82 to 1.57) Experience of childbirth (W-DEQ B): mean (SD) 49.6 ± 26 (number of participants unclear) 50.1 ± 25 (number of participants unclear) MD -0.5 (-3.2 to 4.1) Montgomery et al (2007) Computer decision aids vs usual care RCT Not serious Single study Not serious Seriousd None Information group vs usual care group: elective CS 117/240 (48.8%) 118/238 (49.6%) RR 0.98 (0.82 to 1.18) MODERATEd Decision analysis group vs usual care group: elective CS 97/235 (41.3%) 118/238 (49.6%) RR 0.83 (0.68 to 1.02) Information group vs usual care group: emergency CS 53/240 (22.1%) 48/238 (20.2%) RR 1.09 (0.77 to 1.55) Decision analysis group vs usual care group: emergency CS 50/235 (21.3%) 48/238 (20.2%) RR 1.05 (0.74 to 1.50) Decision analysis vs usual care group: vaginal birth 88/235 (37.5%) 72/238 (30.3%) RR 1.24 (0.96 to 1.60) Information group vs usual care group: vaginal birth 70/240 (29.2%) 72/238 (30.3%) RR 0.96 (0.73 to 1.27) WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 6 Web annex 3 GRADE evidence tables Bastani et al (2006) Nurse-led applied relaxation training programme RCT Seriousb Single study Not serious Seriousa None CS 8/52 (15.4%) 21/52 (40.4%) RR 0.22 (0.11 to 0.43) LOW a, b Instrumental delivery (forceps and vacuum extraction) 11/52 (21.2%) 25/52 (48.1%) RR 0.44 (0.24 to 0.80) Shorten et al (2005) Decision-aid booklet RCT Not serious Single study Not serious Seriousa None Elective repeat CS Baseline: 29.6% Follow-up: 52.2% (n = 115) Baseline: 23.2% Follow-up: 49.4% (n = 112) Absolute change from baseline: 26.2% vs 22.6% Difference in absolute change from baseline: -3.6% (NS) MODERATEa Decisional conflict scores Baseline: 2.34 Follow-up: 1.94 Change in score: -0.40 (-0.51 to -0.29); n = 99 Baseline: 2.26 Follow-up: 2.18 Change in score: -0.08 (-0.22 to 0.06); n = 88 P < 0.05 Satisfaction with birth experience (scale: 1 to 10) Mean satisfaction rating: 7.70 Mean satisfaction rating: 7.90 NS Saisto et al (2001) Intensive group therapy (cognitive behavioural therapy and childbirth psychotherapy) RCT Seriousb Single study Not serious Seriousa None CS 37/85 (43.5%) 44/91 (48.4%) RR 0.90 (0.65 to 1.24) LOW a, b CS for psychosocial reasons 20/85 (23.5%) 26/91 (28.6%) RR 0.82 (0.50 to 1.36) Satisfaction with childbirth (scale: from 1 to 5) Mean score, SD: 3.7 ± 1.4 Mean score, SD: 4.0 ± 1.3 NS WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 7 Web annex 3 GRADE evidence tables Fraser et al (1997) Individualized prenatal education and support programme vs written information in pamphlet RCT Not serious Single study Not serious Seriousa None Overall CS 302/641 (47.1%) 324/634 (51.1%) RR 0.92 (0.82 to 1.03) MODERATEa Scheduled CS 137/641 (21.4%) 150/634 (23.7%) RR 0.90 (0.74 to 1.11) Urgent CS 39/641 (6.1%) 44/634 (6.9%) RR 0.88 (0.58 to 1.33) VBAC 339/641 (53%) 310/634 (49%) RR 1.08 (0.97 to 1.21) Birth experience Mean score, SD: 75.2 ± 20.7 Mean score, SD: 74.2 ± 21.8 P = 0.59 Maternal morbidity and neonatal outcomes Rates of maternal morbidity and neonatal outcomes were similar in the study groups (maternal–uterine rupture or dehiscence, hysterectomy, blood transfusion; neonatal–perinatal deaths, Apgar score less than 7 at 5 minutes, admission to NICU) Navaee & Abedian (2015) Role play education vs standard education using lectures RCT Seriousb Single study Not serious Seriousa None CS 13/35 (37.1%) 18/32 (56.2%) RR 0.66 (0.39 to 1.12) LOW a, b Eden et al (2014) Computerized decision aid vs educational brochures RCT Seriousb Single study Not serious Seriousa None Decisional conflict (overall, women in third trimester) Mean score: Baseline: 19.4 (12.7 to 26.1) Follow-up: 10.7 (5.6 to 15.9) n = 35 Mean score: Baseline: 16.5 (9.5 to 23.5) Follow-up: 14.1 (8.7 to 19.4) n = 32 MD: -0.32, P = 0.003 LOW a, b VBAC 41% (number of events/participants unclear) 37% (number of events/participants unclear) P = 0.72 WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 8 Web annex 3 GRADE evidence tables CS – caesarean section; DSS – delivery satisfaction scale; MD – mean difference; NICU – neonatal intensive care unit; NS – not significant; OR – odds ratio; RCT – randomized controlled trial; RR – risk ratio; SVD – spontaneous vaginal delivery; VBAC – vaginal birth after cesarean; W-DEQ B – Wijma Delivery Expectancy/Experience Questionnaire– Version B. About the certainty of the evidence (Grading of Recommendations Assessment, Development and Evaluation; GRADE)* High: This research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different † is low. Moderate: This research provides a good indication of the likely effect. The likelihood that the effect will be substantially different † is moderate. Low: This research provides some indication of the likely effect. However, the likelihood that it will be substantially different † is high. Very low: This research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different † is very high. * This is sometimes referred to as “quality of evidence” or “confidence in the estimate” † Substantially different = a large enough difference that it might affect a decision a Downgraded one level for serious imprecision (due to small sample size and few events). b Downgraded one level for serious risk of bias (due to flaws in randomization procedures). c Downgraded one level for serious indirectness (follow-up analyses, not described in the trial report, indicated that the impact on caesarean sections was due to reduced birth complications arising from fetal position (e.g. breech birth) and labour progression). d Downgraded one level due to serious imprecision (95% CI includes appreciable benefit and harm). References Bastani F, Hidarnia A, Montgomery KS, Aguilar-Vafaei ME, Kazemnejad A (2006). Does relaxation education in anxious primigravid Iranian women influence adverse pregnancy outcomes? A randomised controlled trial. J Perinat Neonatal Nurs. 20(2):138–46. Bergström M, Kieler H, Waldenström U (2009). Effects of natural childbirth preparation versus standard antenatal education on epidural rates, experience of childbirth and parental stress in mothers and fathers: a randomised controlled multicentre trial. BJOG. 116(9):1167–76. doi: 10.1111/j.1471-0528.2009.02144.x. Eden KB, Perrin NA, Vesco KK, Guise JM (2014). A randomized comparative trial of two decision tools for pregnant women with prior cesareans. J Obstet Gynecol Neonatal Nurs. 43(5):568–79. doi: 10.1111/1552-6909.12485. WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 9 Web annex 3 GRADE evidence tables Feinberg ME, Roettger ME, Jones DE, Paul IM, Kan ML (2015). Effects of a psychosocial couple-based prevention program on adverse birth outcomes. Matern Child Health J. 19(1):102–11. doi: 10.1007/s10995-014-1500-5. Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E et al (2015). Effects of a midwife psycho-education intervention to reduce childbirth fear on women’s birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 15:284. doi: 10.1186/s12884-015-0721-y. Fraser W, Maunsell E, Hodnett E, Moutquin J-M (1997). Randomized controlled trial of a prenatal vaginal birth after cesarean section education and support program. Am J Obstet Gynecol. 176(2):419–25. Masoumi SZ, Kazemi F, Oshvandi K, Jalali M, Esmaeili-Vardanjani A, Rafiei H (2016). Effect of training preparation for childbirth on fear of normal vaginal delivery and choosing the type of delivery among pregnant women in Hamadan, Iran: a randomized controlled trial. J Family Reprod Health. 10(3):115–21. Montgomery AA, Emmett CL, Fahey T, Jones C, Ricketts I, Patel RR (2007). Two decision aids for mode of delivery among women with previous caesarean section: randomised controlled trial. BMJ. 334(7607):1305. doi: 10.1136/bmj.39217.67101955. Navaee M, Abedian Z (2015). Effect of role play education on primiparous women’s fear of natural delivery and their decision on the mode of delivery. Iran J Nurs Midwifery Res. 20(1):40–6. Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmäki E, Saisto T (2013). Obstetric outcome after intervention for severe fear of childbirth in nulliparous women – randomised trial. BJOG. 120(1):75–84. doi: 10.1111/1471-0528.12011. Saisto T, Salmela-Aro K, Nurmi JE, Könönen T, Halmesmäki E (2001). A randomized controlled trial of intervention in fear of childbirth. Obstet Gynecol. 98(5 Pt 1):820–6. Sharifirad G, Rezaeian M, Soltani R, Javaheri S, Mazaheri MA (2013). A survey on the effects of husbands’ education of pregnant women on knowledge, attitude, and reducing elective cesarean section. J Educ Health Promot. 2:50. doi: 10.4103/2277-9531.119036. Shorten A, Shorten B, Keogh J, West S, Morris J (2005). Making choices for childbirth: a randomised controlled trial of a decision-aid for informed birth after cesarean. Birth. 32(4):252–61. doi: 10.1111/j.0730-7659.2005.00383.x. Valiani M, Haghighatdana Z, Ehsanpour S (2014). Comparison of childbirth training workshop effects on knowledge, attitude, and delivery method between mothers and couples groups referring to Isfahan health centers in Iran. Iran J Nurs Midwifery Res. 19(6):653–8. Wang X, Li GY, Deng, ML (2014). Pelvic floor muscle training as a persistent nursing intervention: Effect on delivery outcome and pelvic floor myodynamia. Int J Nurs Sci. 1(1):48–52. doi: 10.1016/j.ijnss.2014.02.017. WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 10 Web annex 3 GRADE evidence tables TABLE 2. EFFECTS OF INTERVENTIONS TARGETED AT HEALTH-CARE PROFESSIONALS STUDY QUALITY ASSESSMENT OUTCOME INTERVENTION CONTROL EFFECT (95% CIª) OR P-VALUE CERTAINTY (GRADE) DESIGN RISK OF BIAS INCONSISTENCY INDIRECTNESS IMPRECISION OTHER ASPECTS Hemminki et al (2008) Education of public health nurses on childbirth classes CRT Seriousb Single study Not serious Not serious None CS 166/845 (19%) 116/723 (16%) OR 1.29 (0.99 to 1.67) MODERATEb Althabe et al (2004) Evidence- based clinical practice guidelines plus mandatory second opinion RCT Not serious Single study Not serious Not serious None All CS Mean baseline rate (34 735 women): 26.3 Mean follow-up rate (35 675): 24.7 Mean rate change: -1.6 Mean baseline rate (39 175 women): 24.6 Mean follow- up rate (39 638): 24.9 Mean rate change: 0.3 Mean difference in rate change: -1.9 (-3.8 to -0.1) HIGH Elective CS Mean baseline rate (34 735 women): 8.9 Mean follow-up rate (35 675): 9.1 Mean rate change: 0.1 Mean baseline rate (39 175 women): 9.1 Mean follow- up rate (39 638): 9.0 Mean rate change: -0.1 Mean difference in rate change: 0.2 (-1.4 to 1.8) WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 11 Web annex 3 GRADE evidence tables Intrapartum CS Mean baseline rate (34 735 women): 17.4 Mean follow-up rate (35 675): 15.6 Mean rate change: -1.8 Mean baseline rate (39,175 women): 15.4 Mean follow- up rate (39 638): 15.9 Mean rate change: 0.4 Mean difference in rate change: -2.2 (-4.3 to -0.1) Liang et al (2004) Peer review plus mandatory second opinion ITS Seriousc Single study Not serious Not serious None CS Change in level of total caesarean deliveries at 12 months:d -2.4% (-11.4% to 6.7%); Change in slope:d 1.34% (-2.5% to 5.2%) VERY LOW c Scarella et al (2011) Audit and feedback using the Robson classification ITS Seriousc Single study Not serious Not serious None CS Change in level of caesarean deliveries during intervention: -11% (-23.2 to 1.2%), NS Change in slope: -1.1% (-6.4 to 4.2%), NS Change in level of caesarean deliveries in the immediate post-intervention period compared with the intervention period: 8.6% (2.1 to 15.2%), P = 0.022 Change in slope: -0.3% (-1.6 to 0.9%), NS VERY LOW c Mohammadi, Källestål & Essén (2012) Audit and feedback plus financial incentive CBA (reanalysed as ITS) Seriousc Single study Not serious Not serious None CS Change in level of caesarean deliveries during the intervention: -14.6% (-24.4% to -4.8%), P = 0.02; Change in slope -0.07% (-1.5% to 1.3%), NS VERY LOW c WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 12 Web annex 3 GRADE evidence tables Chaillet et al (2015) Evidence- based clinical practice guidelines plus audit and feedback Cluster- RCT Not serious Single study Not serious Not serious None Overall CS Baseline: 5484/24 388 (22.5%) Post-intervention: 5128/23 484 (21.8%) Baseline: 6671/28 698 (23.2%) Post-intervention: 6767/28 781 (23.5%) OR 0.90 (0.80 to 0.99)e RD -1.8% (-3.8 to -0.2)e HIGH Elective repeat caesarean section Baseline: 1995/24 388 (8.2%) Post-intervention: 1931/23 484 (8.2%) Baseline: 2404/28 698 (8.4%) Post-intervention: 2598/28 781 (9.0%) RD 0.6 % (-0.07 to 1.28) Low-risk group: CS Baseline: 971/11 478 (8.5%) Post-intervention: 763/10 067 (7.6%) Baseline: 1256/14 717 (8.5%) Post-intervention: 1172/13 019 (9.0%) RD -1.7% (-3.0 to -0.3) Assisted vaginal deliveryf Baseline: 2535/21 449 (11.8%) Post-intervention: 2223/20 612 (10.8%) Baseline: 2574/24 997 (10.3%) Post-intervention: 2605/24 874 (10.5%) RD -1.1 (-2.2 to -0.1) Episiotomyf Baseline: 3762/21 449 (17.5%) Post-intervention: 2953/20 612 (14.3%) Baseline: 4777/24 997 (19.1%) Post-intervention: 3871/24 874 (15.6%) RD 0.1% (-2.0 to 2.7) Major maternal morbidity Baseline: 161/24 388 (0.66%) Post-intervention: 167/23 484 (0.71%) Baseline: 138/28 698 (0.48%) Post-intervention: 141/28 781 (0.49%) RD 0.03% (-0.11 to 0.23) Minor maternal morbidity Baseline: 3293/24 388 (13.5%) Post-intervention: 3576/23 484 (15.2%) Baseline: 3869/28 698 (13.5%) Post-intervention: 4244/28 781 (14.7%) RD 0.3% (-1.2 to 1.8) WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 13 Web annex 3 GRADE evidence tables Major neonatal morbidity Baseline: 1172/24 823 (4.7%) Post-intervention: 1070/23 902 (4.5%) Baseline: 1018/29 107 (3.5%) Post-intervention: 1156/29 211 (4.0%) RD -0.7% (-1.3 to -0.1) Minor neonatal morbidity Baseline: 3936/25 823 (15.9%) Post-intervention: 4261/23 902 (17.8%) Baseline: 3947/29 107 (13.6%) Post-intervention: 5002/29 211 (17.1%) RD -1.7% (-2.6 to -0.9) Intrapartum and neonatal deaths Baseline: 35/24 823 (0.1%) Post-intervention: 20/23 902 (0.1%) Baseline: 14/29 107 (0.0%) Post-intervention: 28/29 211 (0.0%) RD -0.06% (-0.08 to -0.03%) Major trauma Baseline: 258/24 823 (1.0%) Post-intervention: 213/23 902 (0.9%) Baseline: 237/29 107 (0.8%) Post-intervention: 269/29 211 (0.9%) RD -0.23% (-0.40 to -0.01) Use of invasive mechanical ventilation Baseline: 439/24 823 (1.8%) Post-intervention: 335/23 902 (1.4%) Baseline: 289/29 107 (1.0%) Post-intervention: 333/29 211 (1.1%) RD -0.38% (-0.60 to -0.09) Poma (1998) Audit and feedback plus 24-hour in-house coverage by dedicated physician ITS Seriousc Single study Not serious Not serious None CS Change in level of total caesarean deliveries (primary and repeat caesarean sections) at 24 months: -6.6% (-10.1 to -3.2); change in slope: -0.11% (-0.25 to 0.02) (data reanalysed). VERY LOW c WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 14 Web annex 3 GRADE evidence tables Lomas et al (1991) Audit and feedback plus local opinion leader education Cluster- RCT Not serious Single study Not serious Not serious None Audit and feedback (n=524 deliveries) Opinion leader education (n=739 deliveries) Control (n=1233 deliveries) HIGH Elective CS 69.7% (62.4 to 77.0%) 53.7% (46.5 to 61.0%) 66.8% (61.7 to 72.0%) Unscheduled CS 18.6% (13.9 to 23.2%) 21.4% (16.8 to 26.1%) 18.7% (15.4 to 22.1%) Trial of labour rates (%) 21.4% (13.9 to 29.0%) 38.2% (30.6 to 45.7%) 28.3% (23.0 to 33.7%) Vaginal births (%) 11.8% (5.8 to 17.7%) 25.3% (19.3 to 31.2%) 14.5% (10.3 to 18.7%) Low Apgar score < 7 at 5 minutes (%) 5.9 (4.2 to 7.6) 0.9 (0.0 to 2.6) 1.2 (0.0 to 2.4) Duration of hospital stay (%) < 6 days: 27.9 6 days: 29.9 > 6 days: 42.2 < 6 days: 46.6 6 days: 31.4 > 6 days: 22.0 < 6 days: 32.2 6 days: 31.1 > 6 days: 36.7 a Numbers in parentheses are 95% confidence limits; CBA – controlled before-and-after study; CRT – cluster-randomized trial; CS – caesarean section; ITS – interrupted time- series; NS – not significant; OR – odds ratio; RD – risk difference; RR – risk ratio. b Downgraded one level for serious risk of bias (pilot study with no sample size calculation; unit of analysis error). c Downgraded one level for possible confounding (unclear whether the intervention occurred independently of other changes over time). d Two standardized effect sizes are obtained from ITS analysis: change in level (also called ‘step change’) and change in trend (also called ‘change in slope’) before and after the intervention. Change in level = difference between the observed level at the first intervention time point and that predicted by the pre-intervention time trend; Change in trend = difference between post- and pre-intervention slopes. A negative change in level and slope indicates a reduction in caesarean section rate. e Adjusted in between-group comparison of the change from the pre-intervention period to the post-intervention period (adjusted for hospital and patient characteristics). f In women who attempted labour. WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 15 Web annex 3 GRADE evidence tables References Althabe F, Belizán JM, Villar J, Alexander S, Bergel E, Ramos S et al (2004). Mandatory second opinion to reduce rates of unnecessary caesarean sections in Latin America: a cluster randomised controlled trial. Lancet. 363(9425):1934-40. Lancet. 2004 Jun 12;363(9425):1934–40. doi: 10.1016/S0140-6736(04)16406-4. Chaillet N, Dumont A, Abrahamowicz M, Pasquier JC, Audibert F, Monnier P et al (2015). A cluster-randomized trial to reduce cesarean delivery rates in Quebec. N Engl J Med. 372(18):1710–21. doi: 10.1056/NEJMoa1407120. Hemminki E, Heikkilä K, Sevón T, Koponen P (2008). Special features of health services and register based trials – experiences from a randomized trial of childbirth classes. BMC Health Serv Res. 8:126. doi: 10.1186/1472-6963-8-126. Liang WH, Yuan CC, Hung JH, Yang ML, Yang MJ, Chen YJ et al (2004). Effect of peer review and trial of labor on lowering cesarean section rates. J Chin Med Assoc. 67(6):281–6. Lomas J, Enkin M, Anderson GM, Hannah WJ, Vayda E, Singer J (1991). Opinion leaders vs adult and feedback to implement practice guidelines. Delivery after previous cesarean section. JAMA. 265(17):2202–7. Mohammadi S, Källestål C, Essén B (2012). Clinical audits: a practical strategy for reducing cesarean section rates in a general hospital in Tehran, Iran. J Reprod Med. 57(1–2):43–8. Poma PA (1998). Effect of departmental policies on cesarean delivery rates: a community hospital experience. Obstet Gynecol. 91(6):1013–8. Scarella A, Chamy V, Sepúlveda M, Belizán JM (2011). Medical audit using the Ten Group Classification System and its impact on the cesarean section rate. Eur J Obstet Gynecol Reprod Biol. 154(2):136–40. doi: 10.1016/j.ejogrb.2010.09.005. WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 16 Web annex 3 GRADE evidence tables TABLE 3. EFFECTS OF DIFFERENT STAFFING MODELS OF CARE STUDY QUALITY ASSESSMENT OUTCOME INTERVENTION CONTROL RELATIVE EFFECT (95% CI) CERTAINTY (GRADE) DESIGN RISK OF BIAS INCONSISTENCY INDIRECTNESS IMPRECISION OTHER ASPECTS Rosenstein et al (2015) Expanded access to collaborative 24-hour midwifery- labourist care model Cohort (with ITS analysis) Not serious Single study Not serious Not serious None Primary CS Before expansion: 381/1201 (31.7%) After expansion: 130/521 (25.0%) OR 0.56 (0.39 to 0.81) LOW VBAC Before expansion: 60/452 (13.3%) After expansion: 52/232 (22.4%) OR 2.03 (1.08 to 3.80) CI – confidence interval; CS – caesarean section; ITS – interrupted time-series; OR – odds ratio; VBAC – vaginal birth after caesarean section. Reference Rosenstein MG, Nijagal M, Nakagawa S, Gregorich SE, Kuppermann M (2015). The association of expanded access to a collaborative midwifery and laborist model with cesarean delivery rates. Obstet Gynecol. 126(4):716–23. doi: 10.1097/AOG.0000000000001032. WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections 17 Web annex 3 GRADE evidence tables TABLE 4. EFFECTS OF FINANCIAL STRATEGIES TARGETED AT HEALTH-CARE PROFESSIONALS STUDY QUALITY ASSESSMENT OUTCOME EFFECT CERTAINTY (GRADE) DESIGN RISK OF BIAS INCONSISTENCY INDIRECTNESS IMPRECISION OTHER ASPECTS Keeler & Fok (1996) Equalizing physician fees for vaginal and caesarean section delivery ITS Seriousa Single study Not serious Not serious None CS CS rates for non-breech deliveries decreased by 1.2 percentage points (22.5% before reform vs 21.3% after reform) VERY LOW a Lo (2008) Increase physician fees for vaginal birth after caesarean to the same level as for caesarean section; Increase in vaginal birth physician fees to that of caesarean section ITS Seriousa Single study Not serious Not serious None CS The change in the level of total CS rates following the rise in VBAC fees was -1.68 (95% CI -2.3 to -1.07); the change in slope was -0.004 (95% CI -0.05 to 0.04)b The change in the level of total CS rates (for all indications and order of birth) following the rise in vaginal birth fees was 1.19 (95% CI -0.01 to 2.40) and the change in slope was -0.43 (95% CI -0.78 to -0.09)b VERY LOW a WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections CI – confidence interval; CS – caesarean section; ITS – interrupted time series; VBAC – vaginal birth after caesarean. a Downgraded one level for serious risk of bias (due to possible confounding of outcome; it was unclear whether the intervention occurred independently of other changes over time). b Two standardized effect sizes are obtained from ITS analysis: a change in level (also called “step change”) and a change in trend (also called “change in slope”) before and after the intervention. Change in level = difference between the observed level at the first intervention time point and that predicted by the pre-intervention time trend; Change in trend = difference between post- and pre-intervention slopes. A negative change in level and slope indicates a reduction in CS rate. References Keeler EB, Fok T (1996). Equalizing physician fees had little effect on cesarean rates. Med Care Res Rev. 53(4):465–71 Lo JC (2008). Financial incentives do not always work – an example of cesarean sections in Taiwan. Health Policy. 88(1):121–9. doi: 10.1016/j.healthpol.2008.02.013. © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons AttributionNonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; http://creativecommons.org/licenses/by-nc-sa/3.0/igo)