Publications by authors named "Maria Regina Torloni"

103 Publications

Association between prelabour caesarean section and perinatal outcomes: analysis of demographic and health surveys from 26 low-income and middle-income countries.

BMJ Open 2022 Jan 17;12(1):e053049. Epub 2022 Jan 17.

UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Objectives: Caesarean section (CS) conducted before labour (prelabour CS (PLCS)), compared with vaginal birth, may pose additional maternal and perinatal risks. No multicountry analysis has examined PLCS in low-income and middle-income countries (LMICs). This study assessed rates, risk factors and associations of PLCS with perinatal outcomes in LMICs.

Design: Population-based cross-sectional surveys.

Setting: Demographic and Health Surveys conducted between 2015 and 2018 in 26 LMICs (13 countries in Africa, 11 in Asia and 2 in the Americas).

Participants: Women aged 15-49 years with singleton term births.

Outcome Measures: Main outcomes were early neonatal mortality, neonatal mortality, early breastfeeding (within 1 hour of birth), skin-to-skin contact and duration of hospital stay.

Results: 255 227 women were included in the main analysis. Average rates of primary PLCS ranged from 1.3% in Zambia to 19.5% in Maldives. Median PLCS rate was 1.8% in the poorest versus 5.8% in the richest subgroups.Higher maternal age, education, economic status and BMI, lower parity, urban residence, delivery in private hospitals, larger baby size, having health insurance, more antenatal care (ANC) visits, ANC by a doctor and ANC in private hospitals were associated with increased primary PLCS.Across the 26 countries, primary PLCS, compared with vaginal delivery, was associated with increased neonatal mortality (adjusted odds ratio, aOR 1.2, 95% CI 1.0 to 1.5), decreased early breastfeeding (aOR 0.4, 95% CI 0.3 to 0.5) and skin-to-skin contact (aOR 0.4, 95% CI 0.3 to 0.5) and longer hospital stay (aOR 6.6, 95% CI 5.9 to 7.4). No significant association was found for early neonatal mortality (aOR 1.2, 95% CI 0.9 to 1.5).

Conclusion: Primary PLCS, compared with vaginal birth, is associated with adverse perinatal outcomes in singleton term pregnancies in LMICs. Caesarean births should be audited regularly to monitor trends, appropriateness and context-specific drivers of CS.
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http://dx.doi.org/10.1136/bmjopen-2021-053049DOI Listing
January 2022

Collaborative model of intrapartum care: qualitative study on barriers and facilitators to implementation in a private Brazilian hospital.

BMJ Open 2021 Dec 16;11(12):e053636. Epub 2021 Dec 16.

Hospital e Maternidade Santa Joana, Sao Paulo, Brazil.

Introduction: A collaborative (midwife-obstetrician) model of intrapartum care (CMIC) is associated with lower caesarean section (CS) rates than physician-led models. In 2019, the largest private maternity hospital in Latin America (14.000 deliveries/year, 89% CS) created a quality improvement initiative to optimise intrapartum care and safely reduce CS in low-risk women managed by its internal team of healthcare providers (HCP). We conducted formative research to identify potential barriers and facilitators to the implementation of a CMIC.

Methods: Three groups of stakeholders participated in focus groups and interviews: hospital managers and clinical coordinators, HCP working in labour/delivery wards and pregnant women intending to give birth in the hospital. We explored participants' views about the acceptability of implementing a CMIC where a nurse-midwife (NM) on shift would be the main intrapartum HCP, with continuous support/supervision of a dedicated, in-house, obstetrician-gynaecologist (OB-GYN). A thematic analysis approach was used.

Results: 12 HCPs, 5 clinical coordinators, 2 hospital managers and 7 women participated. OB-GYNs, coordinators and managers highlighted health system, organisational and structural factors (NMs' limited experience/skills, professional roles, financial reimbursement) as potential barriers. NMs identified logistical and human resources as additional barriers. Women viewed the CMIC with perplexity and insecurity because of cultural beliefs about the dominant role of OB-GYNs, and limited information about NM's capabilities. All professionals agreed that women's acceptance of a CMIC will require educational interventions and communication strategies to inform potential users about the advantages and safety of this model.

Conclusion: There are important barriers and facilitators to implement a CMIC in a private Brazilian maternity hospital. Factors related to health system structure and organisation may have the greatest impact. A CMIC is more likely to succeed if stakeholders' concerns about responsibilities, power and financial revenues are addressed, and educational interventions targeted at users are deployed prior to its implementation.
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http://dx.doi.org/10.1136/bmjopen-2021-053636DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8679125PMC
December 2021

Post-Placental Intrauterine Device Insertion in Brazilian Adolescents: Clinical Outcomes at 12 Months.

J Pediatr Adolesc Gynecol 2021 Nov 1. Epub 2021 Nov 1.

Obstetrics Department, Universidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina, São Paulo, Brazil.

Study Objective: To assess the acceptability, expulsion and continuation rates, satisfaction, and complications associated with post-placental intrauterine device insertion (PPIUDI) in Brazilian adolescents DESIGN: Prospective cohort SETTING: A single public, tertiary teaching hospital PARTICIPANTS: Adolescents (≤ 19 years) giving birth by vaginal delivery or cesarean section INTERVENTION: PPIUDI MAIN OUTCOME MEASURES: Primary outcomes were PPIUDI acceptability, expulsion, continuation, and user satisfaction. Secondary outcomes were changes in menstrual bleeding and pain, infection, uterine perforation, and repeat pregnancy up to 12 months after PPIUDI.

Results: Of 1710 adolescents who delivered during the study period, 294 accepted PPIUDI (acceptability 17.2%). There were no cases of infection or uterine perforation among the 91 adolescents who completed the 12-month follow-up. Overall expulsion rate was 28.6%, and most cases (54%) occurred in the first 6 weeks after insertion. At 12 months, 85.7% of users were satisfied with the method, and continuation rate was 69.2%. At the end of 12 months, there were no repeat pregnancies among the adolescents who remained with the device in place.

Conclusion: PPIUDI can be an effective and safe method to reduce repeat unplanned pregnancies in adolescents who have just given birth.
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http://dx.doi.org/10.1016/j.jpag.2021.10.009DOI Listing
November 2021

Route of oxytocin administration for preventing blood loss at caesarean section: a systematic review with meta-analysis.

BMJ Open 2021 09 16;11(9):e051793. Epub 2021 Sep 16.

Reproductive Health and Research, UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization, Geneva, Switzerland.

Objectives: Assess the effects of different routes of prophylactic oxytocin administration for preventing blood loss at caesarean section (CS).

Design: Systematic review and meta-analysis.

Methods: Medline, EMBASE, CINAHL, Cochrane Library, BVS, SciELO and Global Index Medicus were searched through 24 May 2020 for randomised controlled trials (RCTs) comparing different routes of prophylactic oxytocin administration during CS. Study selection, data extraction and quality assessment were conducted by two investigators independently. We pooled results in fixed effects meta-analyses and calculated average risk ratio (RR), mean difference (MD) and 95% CI. We used GRADE to assess the overall quality of evidence for each outcome.

Results: Three trials (180 women) were included in the review. All studies compared intramyometrial (IMY) versus intravenous oxytocin in women having prelabour CS. IMY compared with intravenous oxytocin administration may result in little or no difference in the incidence of postpartum haemorrhage (RR 0.14, 95% CI 0.01 to 2.70; N=100 participants; 1 RCT), hypotension (RR 1.00, 95% CI 0.29 to 3.45; N=40; 1 RCT), headache (RR 3.00, 95% CI 0.13 to 69.52; N=40; 1 RCT) or facial flushing (RR 0.50, 95% CI 0.05 to 5.08; N=40; 1 RCT); IMY oxytocin may reduce nausea/vomiting (RR 0.13, 95% CI 0.02 to 0.69; N=140; 2 RCTs). We are very uncertain about the effect IMY versus intravenous oxytocin on the need for additional uterotonics (RR 0.82; 95% CI 0.25 to 2.69; N=140; 2 RCTs). IMY oxytocin may reduce blood loss slightly (MD -57.40 mL, 95% CI -101.71 to -13.09; N=40; 1 RCT).

Conclusions: There is limited, low to very low certainty evidence on the effects of IMY versus intravenous oxytocin at CS for preventing blood loss. The evidence is insufficient to support choosing one route over another. More trials, including studies that assess intramuscular oxytocin administration, are needed on this relevant question.

Prospero Registration Number: CRD42020186797.
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http://dx.doi.org/10.1136/bmjopen-2021-051793DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8449971PMC
September 2021

Good performance of bioimpedance in early pregnancy to predict preeclampsia.

Pregnancy Hypertens 2021 Dec 20;26:24-30. Epub 2021 Aug 20.

Universidade Federal de São Paulo-UNIFESP, Departamento de Obstetrícia, Rua Napoleão de Barros 875, São Paulo, SP, Brazil, CEP: 04024-002, SP, Brazil.

Introduction: Preeclampsia (PE) affects 2-8% of pregnancies and is one of the main causes of maternal morbidity and mortality worldwide. Early identification of pregnant women at higher risk for PE would allow the use of interventions to reduce adverse maternal and perinatal outcomes.

Objective: To assess the ability of bioelectrical impedance analysis (BIA) in pregnancy to predict the development of PE.

Methods: This prospective cohort involved healthy nulliparas who underwent BIA at 17-20 weekś gestation and were followed until delivery. We used univariate and multivariate logistic regression to assess the ability of BIA measures to predict the occurrence of PE. We used an adjusted regression model to estimate the probability of developing PE, the Hosmer-Lemeshow test to assess the adequacy of the final model, and ROC curves to assess the sensitivity and specificity of different BIA measures in the prediction of PE.

Results: Twelve (6.1%) of the 196 participants developed PE. In the final multivariate model, the following BIA measures were associated with the occurrence of PE: extracellular water/intracellular water ≤ 0.618, skeletal muscle mass ≥ 25 Kg, and body fat percentage ≥ 44%. The combination of these three measures had a predictive accuracy of 83.7%, a sensitivity of 83.3%, a specificity of 83.7%, and a negative predictive value of 98.7% for PE.

Conclusion: BIA done on nulliparous women at 17-20 weekś gestation has a good accuracy and high negative predictive value for the risk of developing PE.
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http://dx.doi.org/10.1016/j.preghy.2021.08.115DOI Listing
December 2021

Timing of oxytocin administration to prevent post-partum hemorrhage in women delivered by cesarean section: A systematic review and metanalysis.

PLoS One 2021 3;16(6):e0252491. Epub 2021 Jun 3.

Department of Reproductive Health and Research, World Health Organization, UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Geneva, Switzerland.

Background: There is no consensus on the best timing for prophylactic oxytocin administration during cesarean section (CS) to prevent post-partum hemorrhage (PPH).

Objectives: Assess the effects of administrating prophylactic oxytocin at different times during CS.

Methods: We searched nine databases to identify relevant randomized controlled trials (RCT). We pooled results and calculated average risk ratios (RR), mean differences (MD), and 95% confidence intervals (CI). We used GRADE to assess the overall evidence certainty.

Results: We screened 13,389 references and included four trials. We found no statistically significant differences between oxytocin given before versus after fetal delivery on PPH (RR 0.60, 95%CI 0.15-2.47; 1 RCT, N = 300) or nausea/vomiting (RR 1.21, 95%CI 0.69-2.13; 1 RCT, N = 300). There was a significant reduction in the need for additional uterotonics when oxytocin was given immediately before uterine incision versus after fetal delivery (RR 0.37, 95%CI 0.18-0.73; I2 = 0%; 2 RCTs; N = 301). Oxytocin given before fetal delivery significantly reduced intra-operative blood loss (MD -146.77mL, 95%CI -168.10 to -125.43; I2 = 0%; 3 RCTs, N = 601) but did not change the incidence of blood transfusion (RR 0.50, 95%CI 0.13-1.95; I2 = 0%; 2 RCTs, N = 301) or hysterectomy (RR 3.00; 95%CI 0.12-72.77; I2 = 0%; 2 RCTs, N = 301). One trial (N = 100) compared prophylactic oxytocin before versus after placental separation and found no significant differences on PPH, additional uterotonics, or nausea/vomiting.

Conclusions: In women having pre-labor CS, there is limited evidence indicating no significant differences between prophylactic oxytocin given before versus after fetal delivery on PPH, nausea/vomiting, blood transfusion, or hysterectomy. Earlier oxytocin administration may reduce the volume of blood loss and need for additional uterotonics. There is very limited evidence suggesting no significant differences between prophylactic oxytocin given before versus after placental separation on PPH, need for additional uterotonic, or nausea/vomiting. The overall certainty of the evidence was mostly low or very low due to imprecision. Protocol: CRD42020186797.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252491PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8174699PMC
November 2021

Risk factors for severe and critical Covid-19 in pregnant women in a single center in Brazil.

J Matern Fetal Neonatal Med 2021 Feb 3:1-4. Epub 2021 Feb 3.

Department of Anesthesiology, Hospital e Maternidade Santa Joana, São Paulo, Brazil.

Background: Risk factors for severe SARS-CoV2 infection in pregnancy have not been extensively studied. This information can help guide the management of pregnant women with COVID-19.

Objective: Examine risk factors for severe COVID-19 in pregnant women.

Methods: We reviewed the records of all pregnant women with positive SARS-CoV2 tests (qRT-PCR) managed at a single tertiary private maternity in Sao Paulo, Brazil. We categorized women as having non-severe (mild or moderate) or severe (severe or critical) COVID-19. We conducted multivariable analyses to identify differences in sociodemographic and clinical characteristics of the two groups as risk factors for severe COVID-19.

Results: Between March 13 and June 7 2020, 114 women tested positive for SARS-CoV-2; 80.7% ( = 92) had non-severe disease (69 mild, 23 moderate), 15.7% ( = 18) had severe, and 3.5% ( = 4) had critical COVID-19. Women with severe/critical COVID-19 ( = 22) were significantly older (35.0 ± 5.9 × 31.8 ± 5.1 years,  = 0.011), more likely to have at least one medical comorbidity (81.8% × 52.2%,  = .011) or a history of asthma (18.2% × 3.3%,  = .025), and tended to have a higher median body mass index (30.1 kg/m, IQR 28.1-33.9 × 28.6, IQR 26.2-32.0,  = .056) than women with non-severe disease. Multivariate logistic regression analysis identified four factors as independent predictors of severe/critical COVID-19: asthma (OR 34.469, 95% CI 1.151-78.030,  = .026), non-white ethnicity (OR 7.932, 95% CI 1.311-47.973,  = .024), maternal age with a best cutoff of ≥ 34 years (OR 1.195, 95% CI 1.001-1.427,  = .048) and gestational age at diagnosis with a best cut-off of ≥ 35 weeks (OR 0.876, 95% CI 0.780-0.983,  = .025). The predictive value of the model including all variables was 0.823 ( < .001).

Conclusion: A history of asthma, non-white ethnicity, and older maternal age were risk factors for, while higher gestational age was protective against severe/critical COVID-19 in pregnant Brazilian women.
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http://dx.doi.org/10.1080/14767058.2021.1880561DOI Listing
February 2021

Complementary and alternative therapies for post-caesarean pain.

Cochrane Database Syst Rev 2020 Sep 1;9:CD011216. Epub 2020 Sep 1.

Emergency Medicine and Evidence Based Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Pain after caesarean sections (CS) can affect the well-being of the mother and her ability with her newborn. Conventional pain-relieving strategies are often underused because of concerns about the adverse maternal and neonatal effects. Complementary alternative therapies (CAM) may offer an alternative for post-CS pain.

Objectives: To assess the effects of CAM for post-caesarean pain.

Search Methods: We searched Cochrane Pregnancy and Childbirth's Trials Register, LILACS, PEDro, CAMbase, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (6 September 2019), and checked the reference lists of retrieved articles.

Selection Criteria: Randomised controlled trials (RCTs), including quasi-RCTs and cluster-RCTs, comparing CAM, alone or associated with other forms of pain relief, versus other treatments or placebo or no treatment, for the treatment of post-CS pain.

Data Collection And Analysis: Two review authors independently performed study selection, extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE.

Main Results: We included 37 studies (3076 women) which investigated eight different CAM therapies for post-CS pain relief. There is substantial heterogeneity among the trials. We downgraded the certainty of evidence due to small numbers of women participating in the trials and to risk of bias related to lack of blinding and inadequate reporting of randomisation processes. None of the trials reported pain at six weeks after discharge. Primary outcomes were pain and adverse effects, reported per intervention below. Secondary outcomes included vital signs, rescue analgesic requirement at six weeks after discharge; all of which were poorly reported, not reported, or we are uncertain as to the effect Acupuncture or acupressure We are very uncertain if acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus placebo plus analgesia) has any effect on pain because the quality of evidence is very low. Acupuncture or acupressure plus analgesia (versus analgesia) may reduce pain at 12 hours (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.64 to 0.07; 130 women; 2 studies; low-certainty evidence) and 24 hours (SMD -0.63, 95% CI -0.99 to -0.26; 2 studies; 130 women; low-certainty evidence). It is uncertain whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus analgesia) has any effect on the risk of adverse effects because the quality of evidence is very low. Aromatherapy Aromatherapy plus analgesia may reduce pain when compared with placebo plus analgesia at 12 hours (mean difference (MD) -2.63 visual analogue scale (VAS), 95% CI -3.48 to -1.77; 3 studies; 360 women; low-certainty evidence) and 24 hours (MD -3.38 VAS, 95% CI -3.85 to -2.91; 1 study; 200 women; low-certainty evidence). We are uncertain if aromatherapy plus analgesia has any effect on adverse effects (anxiety) compared with placebo plus analgesia. Electromagnetic therapy Electromagnetic therapy may reduce pain compared with placebo plus analgesia at 12 hours (MD -8.00, 95% CI -11.65 to -4.35; 1 study; 72 women; low-certainty evidence) and 24 hours (MD -13.00 VAS, 95% CI -17.13 to -8.87; 1 study; 72 women; low-certainty evidence). Massage We identified six studies (651 women), five of which were quasi-RCTs, comparing massage (foot and hand) plus analgesia versus analgesia. All the evidence relating to pain, adverse effects (anxiety), vital signs and rescue analgesic requirement was very low-certainty. Music Music plus analgesia may reduce pain when compared with placebo plus analgesia at one hour (SMD -0.84, 95% CI -1.23 to -0.46; participants = 115; studies = 2; I = 0%; low-certainty evidence), 24 hours (MD -1.79, 95% CI -2.67 to -0.91; 1 study; 38 women; low-certainty evidence), and also when compared with analgesia at one hour (MD -2.11, 95% CI -3.11 to -1.10; 1 study; 38 women; low-certainty evidence) and at 24 hours (MD -2.69, 95% CI -3.67 to -1.70; 1 study; 38 women; low-certainty evidence). It is uncertain whether music plus analgesia has any effect on adverse effects (anxiety), when compared with placebo plus analgesia because the quality of evidence is very low. Reiki We are uncertain if Reiki plus analgesia compared with analgesia alone has any effect on pain, adverse effects, vital signs or rescue analgesic requirement because the quality of evidence is very low (one study, 90 women). Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence). Transcutaneous electrical nerve stimulation TENS (versus no treatment) may reduce pain at one hour (MD -2.26, 95% CI -3.35 to -1.17; 1 study; 40 women; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce pain compared with placebo plus analgesia at one hour (SMD -1.10 VAS, 95% CI -1.37 to -0.82; 3 studies; 238 women; low-certainty evidence) and at 24 hours (MD -0.70 VAS, 95% CI -0.87 to -0.53; 108 women; 1 study; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce heart rate (MD -7.00 bpm, 95% CI -7.63 to -6.37; 108 women; 1 study; low-certainty evidence) and respiratory rate (MD -1.10 brpm, 95% CI -1.26 to -0.94; 108 women; 1 study; low-certainty evidence). We are uncertain if TENS plus analgesia (versus analgesia) has any effect on pain at six hours or 24 hours, or vital signs because the quality of evidence is very low (two studies, 92 women).

Authors' Conclusions: Some CAM therapies may help reduce post-CS pain for up to 24 hours. The evidence on adverse events is too uncertain to make any judgements on safety and we have no evidence about the longer-term effects on pain. Since pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of CAM for post-CS pain measure pain as a primary outcome, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Measuring pain as a dichotomous variable would improve the certainty of evidence and it is easy to understand for non-specialists. Future trials also need to be large enough to detect effects on clinical outcomes; measure other important outcomes as listed lin this review, and use validated scales.
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http://dx.doi.org/10.1002/14651858.CD011216.pub2DOI Listing
September 2020

Tribulus Terrestris for Female Sexual Dysfunction: A Systematic Review.

Rev Bras Ginecol Obstet 2020 Jul 31;42(7):427-435. Epub 2020 Jul 31.

Discipline of Evidence-Based Health, Universidade Federal de São Paulo, São Paulo, SP, Brazil.

Objective:  We performed a systematic review to assess the effectiveness and safety of to treat female sexual dysfunction (FSD).

Data Sources:  We performed unrestricted electronic searches in the MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov and OpenGrey databases.

Selection Of Studies:  We included any randomized controlled trials (RCTs) that compared versus inactive/active interventions. After the selection process, conducted by two reviewers, 5 RCTs ( = 279 participants) were included.

Data Collection:  Data extraction was performed by two reviewers with a preestablished data collection formulary.

Data Synthesis:  Due to lack of data and clinical heterogeneity, we could not perform meta-analyses. The risk of bias was assessed by the Cochrane Risk of Bias (RoB) tool, and the certainty of evidence was assessed with Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

Results:  After 1 to 3 months of treatment, premenopausal and postmenopausal women randomized to had a significant increase in sexual function scores. Three months of treatment with showed a significant increase in the serum testosterone levels of premenopausal women. There was no report of serious adverse events, and none of the studies assessed health-related quality of life. The certainty of the evidence was very low, which means that we have very little confidence in the effect estimates, and future studies are likely to change these estimates.

Conclusion:  More RCTs are needed to support or refute the use of . The decision to use this intervention should be shared with the patients, and the uncertainties around its effects should be discussed in the clinical decision-making process.Number of Protocol registration in PROSPERO database: CRD42019121130.
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http://dx.doi.org/10.1055/s-0040-1712123DOI Listing
July 2020

Fetal deaths in pregnancies with SARS-CoV-2 infection in Brazil: A case series.

Case Rep Womens Health 2020 Jul 12;27:e00243. Epub 2020 Jul 12.

Department of Obstetrics, Hospital e Maternidade Santa Joana, São Paulo, Rua Dr. Eduardo Amaro 225, São Paulo, SP CEP 04104-080, Brazil.

Background: There are few reports of miscarriages or stillbirths in women infected with SARS-CoV-2. We present five consecutive cases of fetal death (≥12 weeks) without other putative causes in women with laboratory-confirmed (RT-PCR) COVID-19 managed in a single Brazilian institution.

Case Series: All five women were outpatients with mild or moderate forms of COVID-19 and were not taking any medication. Four were nulliparous, all were overweight or obese, and none had any comorbidities or pregnancy complications that could contribute to fetal demise. Fetal death occurred at 21-38 weeks of gestation, on COVID-days 1-22. SARS-Cov-2 was detected by RT-PCR in amniotic fluid in one case and in placental specimens in two cases. All five women had acute chorioamnionitis on placental histology, massive deposition of fibrin, mixed intervillitis/villitis, and intense neutrophil and lymphocyte infiltration. One fetus had neutrophils inside alveolar spaces, suggestive of fetal infection.

Conclusions: These five cases of fetal demise in women with confirmed COVID-19 without any other significant clinical or obstetric disorders suggest that fetal death can be an outcome of SARS-CoV-2 infection in pregnancy. The intense placental inflammatory reaction in all five cases raises the possibility of a direct effect of SARS-CoV-2 on the placenta.
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http://dx.doi.org/10.1016/j.crwh.2020.e00243DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7354271PMC
July 2020

Quality of medicines for life-threatening pregnancy complications in low- and middle-income countries: A systematic review.

PLoS One 2020 10;15(7):e0236060. Epub 2020 Jul 10.

UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Background: There are concerns about the quality of medicines available in low- and middle-income countries (LMIC) to manage hemorrhage, pre-eclampsia/eclampsia and sepsis. We aimed to identify, critically appraise, and synthesize the findings of studies on the quality of these three types of medicines available in LMIC.

Methods: This systematic review searched Medline, EMBASE and LILACS (from inception to 25 May 2020) for studies on the quality of selected medicines available in LMIC that provided at least the amount of active pharmaceutical ingredient. We contacted study authors for additional information. We excluded simulation studies. We used the MEDQUARG tool to assess study quality. The main outcome was the prevalence of failed samples.

Findings: We identified 9699 unique citations and included 34 studies (3159 samples from 40 countries) in the review. Most studies (65%) had low quality (scores <6/12). Overall, 48.9% of 1890 uterotonic samples (19 studies) failed quality tests; failures rates were 75% for ergometrine and nearly 40% each for oxytocin and misoprostol. The overall prevalence of failed injectable antibiotics (1090 samples, 18 studies) was 13.4%, ranging from 2.9% for injectable metronidazole (34 samples, 3 studies) to 16.0% for cefazolin (449 samples, 2 studies). The prevalence of low quality magnesium sulphate (179 samples, 2 studies) was 3.4%. We did not find any studies on the quality of carbetocin, tranexamic acid, or clindamycin.

Conclusions: There is a widespread problem with the quality of medicines used to manage life-threatening maternal conditions in LMIC. This can be a contributing factor to high maternal mortality rates in these regions.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236060PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351160PMC
September 2020

Possible formation of pulmonary microthrombi in the early puerperium of pregnant women critically ill with COVID-19: Two case reports.

Case Rep Womens Health 2020 Jul 27;27:e00237. Epub 2020 Jun 27.

Hospital e Maternidade Santa Joana, Rua Dr. Eduardo Amaro 225, São Paulo, SP CEP 04104 080, Brazil.

Background: Limited data are available on the management of pregnant women with severe or critical forms of COVID-19, such as the optimal timing of provider-initiated delivery, and post-partum care, including antithrombotic prophylaxis. We present the clinical course, pre- and post-partum management, and outcomes of two pregnant women critically ill with COVID-19.

Cases: Both women had confirmed SARS-CoV-2 pneumonia with rapid clinical decompensation that required admission to the intensive care unit, intubation, and delivery by emergency cesarean section at 32 and 29 weeks. Both patients clinically improved in the first two postoperative days, but this was followed by clinical, laboratory and radiological deterioration on the third postoperative day; however, they both improved again after full anticoagulation. This pattern suggests the possible formation of pulmonary microthrombi in the early puerperium. We discuss the challenges faced by the multiprofessional team in the management of these patients.

Conclusions: There are few resources to guide health professionals caring for pregnant women with critical COVID-19. These two cases contribute to the rapidly evolving knowledge on the management and outcomes of pregnant women with COVID-19.
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http://dx.doi.org/10.1016/j.crwh.2020.e00237DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320266PMC
July 2020

Outcomes associated with anaesthetic techniques for caesarean section in low- and middle-income countries: a secondary analysis of WHO surveys.

Sci Rep 2020 06 23;10(1):10176. Epub 2020 Jun 23.

Evidence Based Healthcare Post Graduate Programme, Department of Medicine, São Paulo Federal University, Rua Botucatu 740, 3o andar, São Paulo, SP, CEP 04023-900, Brazil.

Associations between anaesthetic techniques and pregnancy outcomes were assessed among 129,742 pregnancies delivered by caesarean section (CS) in low- and middle-income countries (LMICs) using two WHO databases. Anaesthesia was categorized as general anaesthesia (GA) and neuraxial anaesthesia (NA). Outcomes included maternal death (MD), maternal near miss (MNM), severe maternal outcome (SMO), intensive care unit (ICU) admission, early neonatal death (END), neonatal near miss (NNM), severe neonatal outcome (SNO), Apgar score <7 at 5 minutes, and neonatal ICU (NICU) admission. A two-stage approach of individual participant data meta-analysis was used to combine the results. Adjusted odds ratio (OR) with 95% confidence intervals (CIs) were presented. Compared to GA, NA were associated with decreased odds of MD (pooled OR 0.28; 95% CI 0.10, 0.78), MNM (pooled OR 0.25; 95% CI 0.21, 0.31), SMO (pooled OR 0.24; 95% CI 0.20,0.28), ICU admission (pooled OR 0.17; 95% CI 0.13, 0.22), NNM (pooled OR 0.63; 95% CI 0.55, 0.73), SNO (pooled OR 0.55; 95% CI 0.48, 0.63), Apgar score <7 at 5 minutes (pooled OR 0.35; 95% CI 0.29, 0.43), and NICU admission (pooled OR 0.53; 95% CI 0.45, 0.62). NA therefore was associated with decreased odds of adverse pregnancy outcomes in LMICs.
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http://dx.doi.org/10.1038/s41598-020-66897-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7311389PMC
June 2020

Mass media campaigns to reduce unnecessary caesarean sections: a systematic review.

BMJ Glob Health 2020 26;5(2):e001935. Epub 2020 Feb 26.

UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Introduction: The worldwide increase in unnecessary caesarean sections (CSs) is a major global health issue. Mass media campaigns have been used in several countries to reduce this trend. The objectives of this systematic review were to identify, critically appraise and synthesise the findings, including the barriers and enablers, of mass media campaigns directed at lay people to reduce unnecessary CS.

Methods: We included any study design that reported health communication mass media campaigns directed at lay people with the specific objective of reducing unnecessary CS, created by any agent, in any format. We searched seven electronic databases without language restrictions, from inception to February 2019. Experts in the field were contacted.

Results: The search yielded 14 320 citations; 50 were selected for full-text reading; and one was included. Six other reports were included. The seven campaigns were conducted in 2009-2017, mostly in Latin America. Most campaigns were independent efforts by non-governmental or activist organisations. Only one campaign conducted formative research and pretested the intervention. All campaigns used indirect communication, mostly through internet channels; two campaigns also used direct communication with the public. None assessed their effects on CS rates. Only two campaigns measured their impacts on participants' knowledge, attitudes and birth preferences but only in the short term. The main barriers were lack of financial and human resources. The main enablers were the enthusiasm of volunteers, the participation of famous persons/celebrities and the involvement of communication professionals.

Conclusions: There are few mass media campaigns directed at lay people to reduce CS. Most campaigns did not use key principles recommended for the creation and implementation of health communication interventions, and none assessed their effects in reducing CS rates. If media campaigns can play a role in modifying population views towards CS, there is a need for more rigorous studies including impact assessment.

Prospero Registration Number: CRD42019120314.
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http://dx.doi.org/10.1136/bmjgh-2019-001935DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7146028PMC
June 2021

Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain.

Cochrane Database Syst Rev 2019 12 12;12:CD011927. Epub 2019 Dec 12.

Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, Cochrane Brazil, Rua Borges Lagoa, 564 cj 63, São Paulo, SP, Brazil, 04038-000.

Background: Chronic neck pain is a highly prevalent condition, affecting 10% to 24% of the general population. Transcutaneous electrical nerve stimulation (TENS) is the noninvasive, transcutaneous use of electrical stimulation to produce analgesia. It is a simple, low-cost and safe intervention used in clinical practice as an adjunct treatment for painful musculoskeletal conditions that have a considerable impact on daily activities, such as chronic neck pain. This review is a split from a Cochrane Review on electrotherapy for neck pain, published in 2013, and focuses specifically on TENS for chronic neck pain.

Objectives: To evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) (alone or in association with other interventions) compared with sham and other clinical interventions for the treatment of chronic neck pain.

Search Methods: We searched Cochrane Back and Neck Trials Register, CENTRAL, MEDLINE, Embase, five other databases and two trials registers to 9 November 2018. We also screened the reference lists of relevant studies to identify additional trials. There were no language, source, or publication date restrictions.

Selection Criteria: We included randomised controlled trials (RCTs) involving adults (≥ 18 years of age) with chronic neck pain (lasting > 12 weeks) that compared TENS alone or in combination with other treatments versus active or inactive treatments. The primary outcomes were pain, disability and adverse events.

Data Collection And Analysis: Two independent review authors selected the trials, extracted data and assessed the risk of bias of included studies. A third review author was consulted in case of disagreements. We used the Cochrane 'Risk of bias' tool (adapted by Cochrane Back and Neck), to assess the risk of bias of individual trials and GRADE to assess the certainty of evidence. We used risk ratios (RRs) to measure treatment effects for dichotomous outcomes, and mean differences (MDs) for continuous outcomes, with their respective 95% confidence intervals (CIs).

Main Results: We included seven RCTs with a total of 651 participants, mean age 31.7 to 55.5 years, conducted in three different countries (Turkey, Jordan and China). The length of follow-up ranged from one week to six months. Most RCTs used continuous TENS, with a frequency of 60 Hz to 100 Hz, pulse width of 40 μs to 250 μs and tolerable intensity, described as a tingling sensation without contraction, in daily sessions lasting 20 to 60 minutes. Due to heterogeneity in interventions and outcomes, we did not pool individual study data into meta-analyses. Overall, we judged most studies as being at low risk for selection bias and high risk for performance and detection bias. Based on the GRADE approach, there was very low-certainty evidence from two trials about the effects of conventional TENS when compared to sham TENS at short-term (up to 3 months after treatment) follow-up, on pain (assessed by the Visual Analogue Scale (VAS)) (MD -0.10, 95% CI -0.97 to 0.77) and the percentage of participants presenting improvement of pain (RR 1.57, 95% CI 0.84 to 2.92). None of the included studies reported on disability or adverse events.

Authors' Conclusions: This review found very low-certainty evidence of a difference between TENS compared to sham TENS on reducing neck pain; therefore, we are unsure about the effect estimate. At present, there is insufficient evidence regarding the use of TENS in patients with chronic neck pain. Additional well-designed, -conducted and -reported RCTs are needed to reach robust conclusions.
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http://dx.doi.org/10.1002/14651858.CD011927.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6953309PMC
December 2019

Vaccines for preventing herpes zoster in older adults.

Cochrane Database Syst Rev 2019 11 7;2019(11). Epub 2019 Nov 7.

Universidade Federal de São Paulo, Department of Geriatrics and Gerontology, Rua Professor Francisco de Castro 105, São Paulo, São Paulo, Brazil, 04020-050.

Background: Herpes zoster, commonly known as shingles, is a neurocutaneous disease caused by the reactivation of the virus that causes varicella (chickenpox). After resolution of the varicella episode, the virus can remain latent in the sensitive dorsal ganglia of the spine. Years later, with declining immunity, the varicella zoster virus (VZV) can reactivate and cause herpes zoster, an extremely painful condition that can last many weeks or months and significantly compromise the quality of life of the affected person. The natural process of aging is associated with a reduction in cellular immunity, and this predisposes older people to herpes zoster. Vaccination with an attenuated form of the VZV activates specific T-cell production avoiding viral reactivation. The USA Food and Drug Administration has approved a herpes zoster vaccine with an attenuated active virus, live zoster vaccine (LZV), for clinical use amongst older adults, which has been tested in large populations. A new adjuvanted recombinant VZV subunit zoster vaccine, recombinant zoster vaccine (RZV), has also been approved. It consists of recombinant VZV glycoprotein E and a liposome-based AS01B adjuvant system. This is an update of a Cochrane Review last updated in 2016.

Objectives: To evaluate the effectiveness and safety of vaccination for preventing herpes zoster in older adults.

Search Methods: For this 2019 update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 1, January 2019), MEDLINE (1948 to January 2019), Embase (2010 to January 2019), CINAHL (1981 to January 2019), LILACS (1982 to January 2019), WHO ICTRP (on 31 January 2019) and ClinicalTrials.gov (on 31 January 2019).

Selection Criteria: We included randomised controlled trials (RCTs) or quasi-RCTs comparing zoster vaccine (any dose and potency) versus any other type of intervention (e.g. varicella vaccine, antiviral medication), placebo, or no intervention (no vaccine). Outcomes were incidence of herpes zoster, adverse events (death, serious adverse events, systemic reactions, or local reaction occurring at any time after vaccination), and dropouts.

Data Collection And Analysis: We used standard methodological procedures expected by Cochrane.

Main Results: We included 11 new studies involving 18,615 participants in this update. The review now includes a total of 24 studies involving 88,531 participants. Only three studies assessed the incidence of herpes zoster in groups that received vaccines versus placebo. Most studies were conducted in high-income countries in Europe and North America and included healthy Caucasians (understood to be white participants) aged 60 years or over with no immunosuppressive comorbidities. Two studies were conducted in Japan. Fifteen studies used LZV. Nine studies tested an RZV. The overall quality of the evidence was moderate. Most data for the primary outcome (incidence of herpes zoster) and secondary outcomes (adverse events and dropouts) came from studies that had a low risk of bias and included a large number of participants. The incidence of herpes zoster at up to three years follow-up was lower in participants who received the LZV (one dose subcutaneously) than in those who received placebo (risk ratio (RR) 0.49, 95% confidence interval (CI) 0.43 to 0.56; risk difference (RD) 2%; number needed to treat for an additional beneficial outcome (NNTB) 50; moderate-quality evidence) in the largest study, which included 38,546 participants. There were no differences between the vaccinated and placebo groups for serious adverse events (RR 1.08, 95% CI 0.95 to 1.21) or deaths (RR 1.01, 95% CI 0.92 to 1.11; moderate-quality evidence). The vaccinated group had a higher incidence of one or more adverse events (RR 1.71, 95% CI 1.38 to 2.11; RD 23%; number needed to treat for an additional harmful outcome (NNTH) 4.3) and injection site adverse events (RR 3.73, 95% CI 1.93 to 7.21; RD 28%; NNTH 3.6) of mild to moderate intensity (moderate-quality evidence). These data came from four studies with 6980 participants aged 60 years or over. Two studies (29,311 participants for safety evaluation and 22,022 participants for efficacy evaluation) compared RZV (two doses intramuscularly, two months apart) versus placebo. Participants who received the new vaccine had a lower incidence of herpes zoster at 3.2 years follow-up (RR 0.08, 95% CI 0.03 to 0.23; RD 3%; NNTB 33; moderate-quality evidence). There were no differences between the vaccinated and placebo groups in incidence of serious adverse events (RR 0.97, 95% CI 0.91 to 1.03) or deaths (RR 0.94, 95% CI 0.84 to 1.04; moderate-quality evidence). The vaccinated group had a higher incidence of adverse events, any systemic symptom (RR 2.23, 95% CI 2.12 to 2.34; RD 33%; NNTH 3.0), and any local symptom (RR 6.89, 95% CI 6.37 to 7.45; RD 67%; NNTH 1.5). Although most participants reported that there symptoms were of mild to moderate intensity, the risk of dropouts (participants not returning for the second dose, two months after the first dose) was higher in the vaccine group than in the placebo group (RR 1.25, 95% CI 1.13 to 1.39; RD 1%; NNTH 100, moderate-quality evidence). Only one study reported funding from a non-commercial source (a university research foundation). All of the other included studies received funding from pharmaceutical companies. We did not conduct subgroup and sensitivity analyses AUTHORS' CONCLUSIONS: LZV and RZV are effective in preventing herpes zoster disease for up to three years (the main studies did not follow participants for more than three years). To date, there are no data to recommend revaccination after receiving the basic schedule for each type of vaccine. Both vaccines produce systemic and injection site adverse events of mild to moderate intensity.
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http://dx.doi.org/10.1002/14651858.CD008858.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836378PMC
November 2019

Palliative care interventions for people with multiple sclerosis.

Cochrane Database Syst Rev 2019 Oct 22;10:CD012936. Epub 2019 Oct 22.

Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, Rua Borges Lagoa, 564 cj 63, São Paulo, SP, Brazil, 04038-000.

Background: People with multiple sclerosis (MS) have complex symptoms and different types of needs. These demands include how to manage the burden of physical disability as well as how to organise daily life, restructure social roles in the family and at work, preserve personal identity and community roles, keep self-sufficiency in personal care, and how to be part of an integrated care network. Palliative care teams are trained to keep open full and competent lines of communication about symptoms and disease progression, advanced care planning, and end-of-life issues and wishes. Teams create a treatment plan for the total management of symptoms, supporting people and families on decision-making. Despite advances in research and the existence of many interventions to reduce disease activity or to slow the progression of MS, this condition remains a life-limiting disease with symptoms that impact negatively the lives of people with it and their families.

Objectives: To assess the effects (benefits and harms) of palliative care interventions compared to usual care for people with any form of multiple sclerosis: relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS), primary-progressive MS (PPMS), and progressive-relapsing MS (PRMS) We also aimed to compare the effects of different palliative care interventions.

Search Methods: On 31 October 2018, we conducted a literature search in the specialised register of the Cochrane MS and Rare Diseases of the Central Nervous System Review Group, which contains trials from CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Clinical trials.gov and the World Health Organization International Clinical Trials Registry Platform. We also searched PsycINFO, PEDro and Opengrey. We also handsearched relevant journals and screened the reference lists of published reviews. We contacted researchers in palliative care and multiple sclerosis.

Selection Criteria: Randomised controlled trials (RCTs) and cluster randomised trials were eligible for inclusion, as well as the first phase of cross-over trials. We included studies that compared palliative care interventions versus usual care. We also included studies that compared palliative care interventions versus another type of palliative interventions.

Data Collection And Analysis: We used standard Cochrane methodological procedures. We summarised key results and certainty of evidence in a 'Summary of Finding' table that reported outcomes at six or more months of post-intervention.

Main Results: Three studies (146 participants) met our selection criteria. Two studies compared multidisciplinary, fast-track palliative care versus multidisciplinary standard care while on a waiting-list control, and one study compared a multidisciplinary palliative approach versus multidisciplinary standard care at different time points (12, 16, and 24 weeks). Two were RCTs with parallel design (total 94 participants) and one was a cross-over design (52 participants). The three studies assessed palliative care as a home-based intervention. One of the three studies included participants with 'neurodegenerative diseases', with MS people being a subset of the randomised population. We assessed the risk of bias of included studies using Cochrane's 'Risk of Bias' tool.We found no evidence of differences between intervention and control groups in long-time follow-up (> six months post-intervention) for the following outcomes: mean change in health-related quality of life (SEIQoL - higher scores mean better quality of life; MD 4.80, 95% CI -12.32 to 21.92; participants = 62; studies = 1; very low-certainty evidence), serious adverse events (RR 0.97, 95% CI 0.44 to 2.12; participants = 76; studies = 1, 22 events, low-certainty evidence) and hospital admission (RR 0.78, 95% CI 0.24 to 2.52; participants = 76; studies = 1, 10 events, low-certainty evidence).The three included studies did not assess the following outcomes at long term follow-up (> six months post intervention): fatigue, anxiety, depression, disability, cognitive function, relapse-free survival, and sustained progression-free survival.We did not find any trial that compared different types of palliative care with each other.

Authors' Conclusions: Based on the findings of the RCTs included in this review, we are uncertain whether palliative care interventions are beneficial for people with MS. There is low- or very low-certainty evidence regarding the difference between palliative care interventions versus usual care for long-term health-related quality of life, adverse events, and hospital admission in patients with MS. For intermediate-term follow-up, we are also uncertain about the effects of palliative care for the outcomes: health-related quality of life (measured by different assessments: SEIQoL or MSIS), disability, anxiety, and depression.
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http://dx.doi.org/10.1002/14651858.CD012936.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6803560PMC
October 2019

The Brazilian Portuguese Version of the DISCERN Instrument: Translation Procedures and Psychometric Properties.

Value Health Reg Issues 2019 Dec 14;20:172-179. Epub 2019 Oct 14.

Discipline of Evidence-Based Medicine, Escola Paulista de Medicina, and Post-Graduation Program of Evidence-Based Health, Universidade Federal de São Paulo, São Paulo, Brazil; Cochrane Brazil, São Paulo, Brazil; Center of Health Technological Assessment, Instituto Sírio-Libanês de Ensino e Pesquisa, Hospital Sírio-Libanês, São Paulo, Brazil.

Objectives: To report on the translation procedures and psychometric properties of the DISCERN tool in Brazilian Portuguese.

Methods: Three people translated the DISCERN from English into Brazilian Portuguese. A committee of experts and community representatives evaluated the quality of the 3 versions in 2 online voting rounds. Two native speakers back-translated the questionnaire into English. We compared these versions to the original DISCERN and made small adjustments. The final Brazilian Portuguese version of DISCERN was tested twice by journalism students to evaluate the quality of a text about smoking cessation treatments. We evaluated participants' health literacy with the Short Assessment of Health Literacy for Portuguese-Speaking Adults (SAHL-PA) tool, assessed the internal consistency of the translated questionnaire with the Cronbach test, and measured its reproducibility with the intraclass correlation coefficient (ICC). We then investigated the relationship between DISCERN and SAHL-PA scores and demographic variables.

Results: The participants (n = 126) had no difficulty in using the questionnaire. Cronbach's alpha was 0.865 (95% confidence interval [CI], 0.826-0.898), and the ICC between the 2 evaluations was 0.845 (CI 0.717-0.912). The mean health literacy of the participants was adequate. There was no correlation between the DISCERN score and the SAHL-PA score, age, or sex (P > .05).

Conclusions: The Brazilian Portuguese version of the DISCERN questionnaire has excellent internal consistency and good reproducibility. The evaluators' ages, sex, and health literacy did not interfere with the score resulting from the evaluation of the quality of the text.
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December 2019

Obstetric emergency simulation training course: experience of a private-public partnership in Brazil.

Reprod Health 2019 Feb 27;16(1):24. Epub 2019 Feb 27.

Hospital e Maternidade Santa Joana, Centro de Ensino, Pesquisa e Inovação, Rua Dr. Eduardo Amaro 225, São Paulo, SP, CEP 04104 080, Brazil.

Background: Lack of skills on how to diagnose and manage obstetric emergencies contribute to substandard institutional care and preventable maternal deaths in Brazil. Simulation-based obstetric emergency team training can reduce adverse maternal outcomes. However, this type of training is expensive and not widely available, especially in low resource settings. We present the experience of a private-public partnership that offered a two-day obstetric emergency simulation-training course to hundreds of Brazilian professionals working in the public sector. We also present participants´ short-term learning outcomes (Kirkpatrick's level 2) and satisfaction (Kirkpatrick's level 1).

Methods: This was a non-experimental before-and-after study. The free 16-h course was held over a 14 months period in a large private hospital's simulation center using multidisciplinary scenario and model-based training. The training sessions consisted of four (4-h) modules on pre-eclampsia/eclampsia, hemorrhage, sepsis and resuscitation. An anonymous questionnaire collected participants´ satisfaction at the end of each module. Learning outcomes were assessed by comparing differences in participants´ pre- versus immediate post-course test scores. Wilcoxon, Kruskal-Wallis and Friedman tests were used for statistical analyses. P < 0.05 was considered significant.

Results: 340 professionals (117 doctors, 179 registered nurses-RN and 44 licensed practical nurses-LPN) working in 33 public Brazilian hospitals were trained. There was a significant increase in post-course test scores in all four modules. On average, scores increased 55% in the hypertension and 65-69% in the hemorrhage, sepsis and resuscitation modules (p = 0.019). Knowledge acquisition of RN and LPN was similar in the hypertension, hemorrhage and sepsis modules and significantly higher than doctors´ (p < 0.05). On a 0 to 10 scale, mean overall satisfaction ranged from 9.6 (for the hypertension module) to 9.8 (for the resuscitation module).

Conclusions: This successful experience of a private-public partnership to offer obstetric emergency simulation training required strategic organization and a strong commitment from both sides. This promising private-public partnership model could be replicated in similar settings. The training course obtained high satisfaction scores and significantly improved the knowledge of public-sector health professionals on how to manage the main causes of maternal mortality.
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http://dx.doi.org/10.1186/s12978-019-0689-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391815PMC
February 2019

Interventions to reduce unnecessary caesarean sections in healthy women and babies.

Lancet 2018 10;392(10155):1358-1368

School of Community Health and Midwifery, Faculty of Health and Wellbeing, University of Central Lancashire, Preston, UK.

Optimising the use of caesarean section (CS) is of global concern. Underuse leads to maternal and perinatal mortality and morbidity. Conversely, overuse of CS has not shown benefits and can create harm. Worldwide, the frequency of CS continues to increase, and interventions to reduce unnecessary CSs have shown little success. Identifying the underlying factors for the continuing increase in CS use could improve the efficacy of interventions. In this Series paper, we describe the factors for CS use that are associated with women, families, health professionals, and health-care organisations and systems, and we examine behavioural, psychosocial, health system, and financial factors. We also outline the type and effects of interventions to reduce CS use that have been investigated. Clinical interventions, such as external cephalic version for breech delivery at term, vaginal breech delivery in appropriately selected women, and vaginal birth after CS, could reduce the frequency of CS use. Approaches such as labour companionship and midwife-led care have been associated with higher proportions of physiological births, safer outcomes, and lower health-care costs relative to control groups without these interventions, and with positive maternal experiences, in high-income countries. Such approaches need to be assessed in middle-income and low-income countries. Educational interventions for women should be complemented with meaningful dialogue with health professionals and effective emotional support for women and families. Investing in the training of health professionals, eliminating financial incentives for CS use, and reducing fear of litigation is fundamental. Safe, private, welcoming, and adequately resourced facilities are needed. At the country level, effective medical leadership is essential to ensure CS is used only when indicated. We conclude that interventions to reduce overuse must be multicomponent and locally tailored, addressing women's and health professionals' concerns, as well as health system and financial factors.
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October 2018

Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems.

Cochrane Database Syst Rev 2018 10 1;10:CD001059. Epub 2018 Oct 1.

Walter Sisulu University, University of Fort Hare, University of the Witwatersrand, Eastern Cape Department of Health, East London, South Africa.

Background: Pre-eclampsia and eclampsia are common causes of serious morbidity and death. Calcium supplementation may reduce the risk of pre-eclampsia, and may help to prevent preterm birth. This is an update of a review last published in 2014.

Objectives: To assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child outcomes.

Search Methods: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (18 September 2017), and reference lists of retrieved studies.

Selection Criteria: We included randomised controlled trials (RCTs), including cluster-randomised trials, comparing high-dose calcium supplementation (at least 1 g daily of calcium) during pregnancy with placebo. For low-dose calcium we included quasi-randomised trials, trials without placebo, trials with cointerventions and dose comparison trials.

Data Collection And Analysis: Two researchers independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two researchers assessed the evidence using the GRADE approach.

Main Results: We included 27 studies (18,064 women). We assessed the included studies as being at low risk of bias, although bias was frequently difficult to assess due to poor reporting and inadequate information on methods.High-dose calcium supplementation (≥ 1 g/day) versus placeboFourteen studies examined this comparison, however one study contributed no data. The 13 studies contributed data from 15,730 women to our meta-analyses. The average risk of high blood pressure (BP) was reduced with calcium supplementation compared with placebo (12 trials, 15,470 women: risk ratio (RR) 0.65, 95% confidence interval (CI) 0.53 to 0.81; I² = 74%). There was also a reduction in the risk of pre-eclampsia associated with calcium supplementation (13 trials, 15,730 women: average RR 0.45, 95% CI 0.31 to 0.65; I² = 70%; low-quality evidence). This effect was clear for women with low calcium diets (eight trials, 10,678 women: average RR 0.36, 95% CI 0.20 to 0.65; I² = 76%) but not those with adequate calcium diets. The effect appeared to be greater for women at higher risk of pre-eclampsia, though this may be due to small-study effects (five trials, 587 women: average RR 0.22, 95% CI 0.12 to 0.42). These data should be interpreted with caution because of the possibility of small-study effects or publication bias. In the largest trial, the reduction in pre-eclampsia was modest (8%) and the CI included the possibility of no effect.The composite outcome maternal death or serious morbidity was reduced with calcium supplementation (four trials, 9732 women; RR 0.80, 95% CI 0.66 to 0.98). Maternal deaths were no different (one trial of 8312 women: one death in the calcium group versus six in the placebo group). There was an anomalous increase in the risk of HELLP syndrome in the calcium group (two trials, 12,901 women: RR 2.67, 95% CI 1.05 to 6.82, high-quality evidence), however, the absolute number of events was low (16 versus six).The average risk of preterm birth was reduced in the calcium supplementation group (11 trials, 15,275 women: RR 0.76, 95% CI 0.60 to 0.97; I² = 60%; low-quality evidence); this reduction was greatest amongst women at higher risk of developing pre-eclampsia (four trials, 568 women: average RR 0.45, 95% CI 0.24 to 0.83; I² = 60%). Again, these data should be interpreted with caution because of the possibility of small-study effects or publication bias. There was no clear effect on admission to neonatal intensive care. There was also no clear effect on the risk of stillbirth or infant death before discharge from hospital (11 trials, 15,665 babies: RR 0.90, 95% CI 0.74 to 1.09).One study showed a reduction in childhood systolic BP greater than 95th percentile among children exposed to calcium supplementation in utero (514 children: RR 0.59, 95% CI 0.39 to 0.91). In a subset of these children, dental caries at 12 years old was also reduced (195 children, RR 0.73, 95% CI 0.62 to 0.87).Low-dose calcium supplementation (< 1 g/day) versus placebo or no treatmentTwelve trials (2334 women) evaluated low-dose (usually 500 mg daily) supplementation with calcium alone (four trials) or in association with vitamin D (five trials), linoleic acid (two trials), or antioxidants (one trial). Most studies recruited women at high risk for pre-eclampsia, and were at high risk of bias, thus the results should be interpreted with caution. Supplementation with low doses of calcium reduced the risk of pre-eclampsia (nine trials, 2234 women: RR 0.38, 95% CI 0.28 to 0.52). There was also a reduction in high BP (five trials, 665 women: RR 0.53, 95% CI 0.38 to 0.74), admission to neonatal intensive care unit (one trial, 422 women, RR 0.44, 95% CI 0.20 to 0.99), but not preterm birth (six trials, 1290 women, average RR 0.83, 95% CI 0.34 to 2.03), or stillbirth or death before discharge (five trials, 1025 babies, RR 0.48, 95% CI 0.14 to 1.67).High-dose (=/> 1 g) versus low-dose (< 1 g) calcium supplementationWe included one trial with 262 women, the results of which should be interpreted with caution due to unclear risk of bias. Risk of pre-eclampsia appeared to be reduced in the high-dose group (RR 0.42, 95% CI 0.18 to 0.96). No other differences were found (preterm birth: RR 0.31, 95% CI 0.09 to 1.08; eclampsia: RR 0.32, 95% CI 0.07 to 1.53; stillbirth: RR 0.48, 95% CI 0.13 to 1.83).

Authors' Conclusions: High-dose calcium supplementation (≥ 1 g/day) may reduce the risk of pre-eclampsia and preterm birth, particularly for women with low calcium diets (low-quality evidence). The treatment effect may be overestimated due to small-study effects or publication bias. It reduces the occurrence of the composite outcome 'maternal death or serious morbidity', but not stillbirth or neonatal high care admission. There was an increased risk of HELLP syndrome with calcium supplementation, which was small in absolute numbers.The limited evidence on low-dose calcium supplementation suggests a reduction in pre-eclampsia, hypertension and admission to neonatal high care, but needs to be confirmed by larger, high-quality trials.
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http://dx.doi.org/10.1002/14651858.CD001059.pub5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517256PMC
October 2018

What do Cochrane systematic reviews say about new practices on integrative medicine?

Sao Paulo Med J 2018 May-Jun;136(3):251-261. Epub 2018 Jun 25.

MD, MSc, PhD. Nephrologist; Full Professor, Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp); and Director, Cochrane Brazil, São Paulo (SP), Brazil.

Background: This study identified and summarized all Cochrane systematic reviews (SRs) on the effects of ten integrative practices that were recently added to the Brazilian public healthcare system (SUS).

Design And Setting: Review of systematic reviews, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp).

Methods: Review of Cochrane SRs on the following interventions were identified, summarized and critically assessed: apitherapy, aromatherapy, bioenergetics, family constellation, flower therapy, chromotherapy, geotherapy, hypnotherapy, hand imposition or ozone therapy.

Results: We included a total of 16 SRs: 4 on apitherapy, 4 on aromatherapy, 6 on hypnotherapy and 2 on ozone therapy. No Cochrane SR was found regarding bioenergetics, family constellation, chromotherapy, clay therapy, flower therapy or hand imposition. The only high-quality evidence was in relation to the potential benefit of apitherapy, specifically regarding some benefits from honey dressings for partial healing of burn wounds, for reduction of coughing among children with acute coughs and for preventing allergic reactions to insect stings.

Conclusion: Except for some specific uses of apitherapy (honey for burn wounds and for acute coughs and bee venom for allergic reactions to insect stings), the use of ten integrative practices that have recently been incorporated into SUS does not seem to be supported by evidence from Cochrane SRs.
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http://dx.doi.org/10.1590/1516-3180.2018.0172170418DOI Listing
August 2018

Microbiome in normal and pathological pregnancies: A literature overview.

Am J Reprod Immunol 2018 08 6;80(2):e12993. Epub 2018 Jun 6.

Department of Obstetrics, Universidade Federal de São Paulo, São Paulo, Brazil.

This review summarizes recent findings on the changes that occur during pregnancy in the composition of the vaginal and gut microbiome and their association with metabolic, hormonal, and immunological factors. Despite many studies on the topic, the vaginal and gut microbial profiles and their influence on the course of pregnancy are still unclear. We present data suggesting that, contrary to traditional understanding, the placenta is not sterile but has a microbial community. We review and discuss new findings on changes in the richness and diversity of the microbiota of pregnant women with term or preterm births, obesity, and gestational diabetes mellitus. Several factors influence the bacterial profile of these women and may explain, at least in part, some of the discrepant findings between studies. The development of and access to new molecular biology methods and techniques has expanded the possibilities of research. This will contribute to a better understanding of the microbiome and its role in normal and pathological pregnancies.
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http://dx.doi.org/10.1111/aji.12993DOI Listing
August 2018

Risk of maternal mortality in women with severe anaemia during pregnancy and post partum: a multilevel analysis.

Lancet Glob Health 2018 05 20;6(5):e548-e554. Epub 2018 Mar 20.

Barts Research Centre for Women's Health, WHO Collaborating Centre, Queen Mary University of London, London, UK.

Background: Anaemia affects as many as half of all pregnant women in low-income and middle-income countries, but the burden of disease and associated maternal mortality are not robustly quantified. We aimed to assess the association between severe anaemia and maternal death with data from the WHO Multicountry Survey on maternal and newborn health.

Methods: We used multilevel and propensity score regression analyses to establish the relation between severe anaemia and maternal death in 359 health facilities in 29 countries across Latin America, Africa, the Western Pacific, eastern Mediterranean, and southeast Asia. Severe anaemia was defined as antenatal or postnatal haemoglobin concentrations of less than 70 g/L in a blood sample obtained before death. Maternal death was defined as death any time after admission until the seventh day post partum or discharge. In regression analyses, we adjusted for post-partum haemorrhage, general anaesthesia, admission to intensive care, sepsis, pre-eclampsia or eclampsia, thrombocytopenia, shock, massive transfusion, severe oliguria, failure to form clots, and severe acidosis as confounding variables. These variables were used to develop the propensity score.

Findings: 312 281 women admitted in labour or with ectopic pregnancies were included in the adjusted multilevel logistic analysis, and 12 470 were included in the propensity score regression analysis. The adjusted odds ratio for maternal death in women with severe anaemia compared with those without severe anaemia was 2·36 (95% CI 1·60-3·48). In the propensity score analysis, severe anaemia was also associated with maternal death (adjusted odds ratio 1·86 [95% CI 1·39-2·49]).

Interpretation: Prevention and treatment of anaemia during pregnancy and post partum should remain a global public health and research priority.

Funding: Barts and the London Charity.
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http://dx.doi.org/10.1016/S2214-109X(18)30078-0DOI Listing
May 2018

Breast surgery for metastatic breast cancer.

Cochrane Database Syst Rev 2018 Mar 15;3:CD011276. Epub 2018 Mar 15.

Iamada Hospital, Cassemiro Boscoli 236, Jd Icaray, Presidente Prudente, Sao Paulo, Brazil, 19060-530.

Background: Metastatic breast cancer is not a curable disease, but women with metastatic disease are living longer. Surgery to remove the primary tumour is associated with an increased survival in other types of metastatic cancer. Breast surgery is not standard treatment for metastatic disease, however several recent retrospective studies have suggested that breast surgery could increase the women's survival. These studies have methodological limitations including selection bias. A systematic review mapping all randomised controlled trials addressing the benefits and potential harms of breast surgery is ideal to answer this question.

Objectives: To assess the effects of breast surgery in women with metastatic breast cancer.

Search Methods: We conducted searches using the MeSH terms 'breast neoplasms', 'mastectomy', and 'analysis, survival' in the following databases: the Cochrane Breast Cancer Specialised Register, CENTRAL, MEDLINE (by PubMed) and Embase (by OvidSP) on 22 February 2016. We also searched ClinicalTrials.gov (22 February 2016) and the WHO International Clinical Trials Registry Platform (24 February 2016). We conducted an additional search in the American Society of Clinical Oncology (ASCO) conference proceedings in July 2016 that included reference checking, citation searching, and contacting study authors to identify additional studies.

Selection Criteria: The inclusion criteria were randomised controlled trials of women with metastatic breast cancer at initial diagnosis comparing breast surgery plus systemic therapy versus systemic therapy alone. The primary outcomes were overall survival and quality of life. Secondary outcomes were progression-free survival (local and distant control), breast cancer-specific survival, and toxicity from local therapy.

Data Collection And Analysis: Two review authors independently conducted trial selection, data extraction, and 'Risk of bias' assessment (using Cochrane's 'Risk of bias' tool), which a third review author checked. We used the GRADE tool to assess the quality of the body of evidence. We used the risk ratio (RR) to measure the effect of treatment for dichotomous outcomes and the hazard ratio (HR) for time-to-event outcomes. We calculated 95% confidence intervals (CI) for these measures. We used the random-effects model, as we expected clinical or methodological heterogeneity, or both, among the included studies.

Main Results: We included two trials enrolling 624 women in the review. It is uncertain whether breast surgery improves overall survival as the quality of the evidence has been assessed as very low (HR 0.83, 95% CI 0.53 to 1.31; 2 studies; 624 women). The two studies did not report quality of life. Breast surgery may improve local progression-free survival (HR 0.22, 95% CI 0.08 to 0.57; 2 studies; 607 women; low-quality evidence), while it probably worsened distant progression-free survival (HR 1.42, 95% CI 1.08 to 1.86; 1 study; 350 women; moderate-quality evidence). The two included studies did not measure breast cancer-specific survival. Toxicity from local therapy was reported by 30-day mortality and did not appear to differ between the two groups (RR 0.99, 95% CI 0.14 to 6.90; 1 study; 274 women; low-quality evidence).

Authors' Conclusions: Based on existing evidence from two randomised clinical trials, it is not possible to make definitive conclusions on the benefits and risks of breast surgery associated with systemic treatment for women diagnosed with metastatic breast cancer. Until the ongoing clinical trials are finalised, the decision to perform breast surgery in these women should be individualised and shared between the physician and the patient considering the potential risks, benefits, and costs of each intervention.
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http://dx.doi.org/10.1002/14651858.CD011276.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6494198PMC
March 2018

Coverage, completeness and reliability of the data in the Information System on Live Births in public maternity wards in the municipality in São Paulo, Brazil, 2011.

Epidemiol Serv Saude 2018 15;27(1):e201712811. Epub 2018 Feb 15.

Programa de Pós-Graduação em Saúde baseada em Evidências, Universidade Federal de São Paulo, São Paulo, SP, Brazil.

Objective: to assess the coverage, completeness and reliability of data on live births in public maternity wards in São Paulo, Brazil.

Methods: data recorded in the Information System on Live Births (Sinasc) were compared with data collected in a field study (gold standard) during three months in 2011 in four maternity wards in hospital from the SUS network; kappa coefficient was calculated to assess agreement.

Results: 5,785 birth records were analyzed; Sinasc coverage was 99.8% and completeness was 96.2%; kappa values showed excellent and good agreement for maternal age (0.99), type of pregnancy, sex and newborn sex and birth weight (0.98), type of delivery (0.97), 1 minute (0.96) and 5th (0.95) minutes, previous live births (0.87) and education level (0.62); regular agreement for prenatal care visits (0.60) and gestational age (0.56); and weak agreement for previous stillbirths (0.09).

Conclusion: in the assessed hospitals, Sinasc presented high coverage, completeness and reliability.
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http://dx.doi.org/10.5123/s1679-49742018000100011DOI Listing
January 2019

Within country inequalities in caesarean section rates: observational study of 72 low and middle income countries.

BMJ 2018 01 24;360:k55. Epub 2018 Jan 24.

Department of Information, Evidence and Research, World Health Organization, Geneva, 1211, Switzerland

Objective: To provide an update on economic related inequalities in caesarean section rates within countries.

Design: Secondary analysis of demographic and health surveys and multiple indicator cluster surveys.

Setting: 72 low and middle income countries with a survey conducted between 2010 and 2014 for analysis of the latest situation of inequality, and 28 countries with a survey also conducted between 2000 and 2004 for analysis of the change in inequality over time.

Participants: Women aged 15-49 years with a live birth during the two or three years preceding the survey.

Main Outcome Measures: Data on caesarean section were disaggregated by asset based household wealth status and presented separately for five subgroups, ranging from the poorest to the richest fifth. Absolute and relative inequalities were measured using difference and ratio measures. The pace of change in the poorest and richest fifths was compared using a measure of excess change.

Results: National caesarean section rates ranged from 0.6% in South Sudan to 58.9% in the Dominican Republic. Within countries, caesarean section rates were lowest in the poorest fifth (median 3.7%) and highest in the richest fifth (median 18.4%). 18 out of 72 study countries reported a difference of 20 percentage points or higher between the richest and poorest fifth. The highest caesarean section rates and greatest levels of absolute inequality were observed in countries from the region of the Americas, whereas countries from the African region had low levels of caesarean use and comparatively lower levels of absolute inequality, although relative inequality was quite high in some countries. 26 out of 28 countries reported increases in caesarean section rates over time. Rates tended to increase faster in the richest fifth (median 0.9 percentage points per year) compared with the poorest fifth (median 0.2 percentage points per year), indicating an increase in inequality over time in most of these countries.

Conclusions: Substantial within country economic inequalities in caesarean deliveries remain. These inequalities might be due to a combination of inadequate access to emergency obstetric care among the poorest subgroups and high levels of caesarean use without medical indication in the richest subgroups, especially in middle income countries. Country specific strategies should address these inequalities to improve maternal and newborn health.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5782376PMC
http://dx.doi.org/10.1136/bmj.k55DOI Listing
January 2018

Neuromuscular electrical stimulation (NMES) for patellofemoral pain syndrome.

Cochrane Database Syst Rev 2017 Dec 12;12:CD011289. Epub 2017 Dec 12.

Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, Rua Borges Lagoa, 564 cj 63, São Paulo, SP, Brazil, 04038-000.

Background: Patellofemoral pain syndrome, now generally referred to as patellofemoral pain (PFP), is one of the most common orthopaedic disorders, characterised by pain in the anterior or retropatellar knee region. Neuromuscular electrical stimulation (NMES) has been proposed generally as a complementary treatment, associated with other interventions such as exercise, or as a single treatment to increase muscle force, reduce knee pain, and improve function.

Objectives: To assess the effects (benefits and harms) of neuromuscular electrical stimulation for people with patellofemoral pain.

Search Methods: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PEDro, CINAHL, SPORTDiscus, AMED, LILACS, trial registers, conference abstracts, and reference lists. We carried out the search in May 2017.

Selection Criteria: We included randomised controlled clinical trials that evaluated the use of NMES for people with PFP.

Data Collection And Analysis: Two review authors independently performed the process of study selection, data extraction, and 'Risk of bias' assessment in duplicate. The primary outcomes were knee pain, knee function, and adverse events. The timing of outcome measurements was up to three months (short term), three to 12 months (medium term), and 12 months and above from trial entry (long term). We calculated risk ratios for dichotomous data and mean differences or standardised mean differences for continuous data. Where appropriate, we pooled data using the fixed-effect model.

Main Results: We included eight randomised clinical trials, reporting results for 345 participants with PFP. The mean ages of trial populations ranged from 25 to 43 years, and the majority (53% to 100%) of participants were female. There was a wide duration of symptoms, with the minimum duration of symptoms for trial inclusion ranging from one to six months. In addition to the study inclusion criteria, studies varied widely in the characteristics of the NMES and its application, and associated co-interventions. We assessed all trials as at high risk of bias in at least one domain, particularly blinding and incomplete outcome data. The results of a laboratory-based trial reporting knee pain immediately after a single 15-minute session of NMES are not reported here as these are of questionable clinical relevance. The seven remaining trials provided evidence for three comparisons. We assessed the overall quality of the evidence, using GRADE, for all primary outcomes for all comparisons as very low, thus we are very unsure of the findings.Four studies compared NMES plus exercise versus exercise alone. Patellar taping was applied as well as exercise to all participants of one study, and patellar taping and ice were also applied in another study. Each trial tested a different multiple-session NMES programme. Pooled data from three studies (118 participants) provided very low-quality evidence that NMES is associated with reduced pain at the end of treatment (ranging from 3 to 12 weeks): mean difference -1.63, 95% confidence interval (CI) -2.23 to -1.02; visual analogue scale (VAS) 0 to 10; higher scores = worse pain. However, this result may not be clinically relevant since the minimal clinically important difference for VAS during activities (1.5 to 2.0, out of 10 points) lies within the 95% CI. We found very low-quality evidence from pooled data from two trials of little effect of NMES on knee function, as measured by two knee function rating systems. We found inconclusive and very low-quality evidence from one trial (29 participants) of little effect of NMES on pain and function at one-year follow-up. None of the four trials reported on adverse effects of treatment.One study (94 participants) compared NMES, applied four hours per day on a daily basis for four weeks, with two types of exercises (isometric and isokinetic). The study did not report on knee pain or adverse events. The study provided very low-quality evidence of no important difference between the two groups in knee function at the end of the four-week treatment. Of note is the potentially onerous NMES schedule in this study, which does not correspond to that typically used in clinical practice.Two studies compared different types of NMES. Simultaneously delivered high-low frequencies NMES was compared with sequentially delivered high-low frequencies NMES in one trial (14 participants) and with fixed frequency NMES in the second trial (64 participants). The studies provided very low-quality evidence of no important differences at the end of the six-week treatment programme between the simultaneous frequencies NMES and the two other NMES programmes in overall knee pain, knee function, or in quadriceps fatigue (an adverse event).

Authors' Conclusions: This review found insufficient and inconclusive evidence from randomised controlled trials to inform on the role of NMES for treating people with PFP in current clinical practice. The very low-quality evidence available means that we are uncertain whether or not a multiple-session programme of NMES combined with exercise over several weeks versus exercise alone results in clinically important differences in knee pain and function at the end of the treatment period or at one year. There were no data on adverse effects such as muscle fatigue and discomfort. High-quality randomised clinical trials are needed to inform on the use of NMES for people with PFP. However, professional and stakeholder consensus is required on prioritisation of the research questions for interventions for treating people with PFP, including on the NMES treatment protocol for trials testing NMES.
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http://dx.doi.org/10.1002/14651858.CD011289.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6486051PMC
December 2017

Distance Education Course about Sexuality for Obstetrics and Gynecology Residents.

Rev Bras Ginecol Obstet 2017 Dec 27;39(12):670-675. Epub 2017 Nov 27.

Departament of Obstetrics, São Paulo Medical School, Universidade Federal de São Paulo, São Paulo, Brazil.

 To describe the experience of a distance education course on sexual issues during pregnancy and after birth for residents.  This prospective educational intervention study was conducted by investigators from the Universidade Federal de São Paulo, Brazil, between April and September 2014. The participants were 219 physicians (residents from the 1st to the 6th years). The duration of the course was of 24 hours (10 video lectures and online chats). At baseline, the participants answered questions about their training, attitude and experience regarding sexual issues during pregnancy and after birth; before and after the course, they answered questions to assess their knowledge about the topic; at the end of the course, they answered questions on the quality of the course. The Student -test was used to compare the before and after scores of the knowledge tests; values of  < 0.05 were considered statistically significant.  A total of 143 residents concluded the course; most were in their 1st (27.2%) or 3rd (29.4%) years of residency. There was a significant increase in the mean scores of the questionnaires that assessed the knowledge of the topic: 4.4 (±1.6) versus 6.0 (±1.3; maximum score: 10), before and after the course respectively ( < 0.0001). Most of the participants (74.1%) declared that the quality of the course as a whole reached their expectations, and 81.1% would recommend the course to a friend.  The online Sexology course for Obstetrics and Gynecology residents increased their knowledge about the sexual issues during pregnancy and after birth, and fulfilled the participants' expectations. The experience described here may serve as a model for other sexuality courses targeting similar audiences.
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http://dx.doi.org/10.1055/s-0037-1606273DOI Listing
December 2017

Provider-initiated delivery, late preterm birth and perinatal mortality: a secondary analysis of the WHO multicountry survey on maternal and newborn health.

BMJ Glob Health 2017 18;2(2):e000204. Epub 2017 May 18.

Departments of Pediatrics and of Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Quebec, Canada.

Introduction: In high-income countries, a reduced clinical threshold for obstetric interventions such as labour induction (LI) and prelabour caesarean delivery (PLCD) has played a substantial role in increasing rates of late preterm births. However, the association between provider-initiated delivery and perinatal outcomes have not been studied in a multicountry setting including low-income and middle-income countries.

Methods: 286 hospitals in 29 countries participated in the WHO Multi-Country Survey on Maternal and Newborn Health and yielded 2 52 198 singleton births of at least 34 weeks in 2010-2011. We used an ecological analysis based on generalised estimating equations under multilevel logistic regression to estimate associations between hospital rates of PLCD and LI with rates of late preterm birth (34-36 weeks), stillbirth and intrahospital early neonatal death, in relation to country development based on the Human Development Index (HDI).

Results: Rates of LI were higher in hospitals from very high-HDI (median 10.9%) and high-HDI (11.2%) countries compared with medium-HDI (4.0%) or low-HDI (3.8%) countries. Rates of PLCD were by far the lowest in low-HDI countries compared with countries in the other three categories (5.1% vs 12.0%-17.9%). Higher rates of PLCD were associated with lower perinatal death rates (OR 0.87 (0.79, 0.95) per 5% increase in PLCD) and non-significantly with late preterm birth (1.04 (0.98, 1.10)) regardless of country development. LI rates were positively associated with late preterm birth (1.04 (1.01, 1.06)) regardless of country development and with perinatal death (1.06 (0.98, 1.15)) only in middle-HDI and low- HDI countries.

Conclusion: PLCD was associated with reduced perinatal mortality and non-significantly with increased late preterm birth. LI was associated with increases in both late preterm birth and, in less-developed countries, perinatal mortality. Efforts to provide sufficient, but avoid excessive, access to provider-initiated delivery should be tailored to the local context.
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http://dx.doi.org/10.1136/bmjgh-2016-000204DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5444091PMC
May 2017
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