School-based comprehensive sexuality education for prevention of adolescent pregnancy: a scoping review.

BACKGROUND: Adolescent pregnancy is a global public health problem. Numerous approaches for Comprehensive Sexuality Education (CSE) delivery in schools have been implemented around the world. Previous reviews on CSE did not follow the International Technical Guidance on Sexuality Education (ITGSE) because CSE is very diverse in terms of population, interventions, settings and outcomes. We conducted this scoping review to identify and map the evidence of school-based CSE for prevention of adolescent pregnancy with emphasis on adolescents' contraceptive use, unintended pregnancy and abortion. METHODS: We searched PubMed, CENTRAL, Scopus, ISI Web of Science, CINAHL, and WHO ICTRP to identify potential eligible studies from their inception to 4th Nov 2023.We included randomized controlled trials (RCTs) and non-RCTs of CSE implemented in public or private schools for adolescents. CSE was defined as a multi-session intervention in school that covered topics including contraception, pregnancy, abortion, and HIV/STI. School-based interventions were the main intervention that may be either stand-alone or multicomponent. There was no limitation on study's geographical area, but only English-language studies were considered. Two reviewers selected and extracted data independently, discussed for consensus or consulted the third reviewer if there were discrepancies for final conclusion. Data were presented using figures, map and table. RESULTS: Out of 5897 records, 79 studies (101 reports) were included in this review. Most studies were conducted in the United States and other high-income countries in secondary or high schools with cluster RCTs. All studies included participatory methods. Almost all studies included Sexual and Reproductive Health which is the eighth concept of CSE. Very few studies reported the prespecified primary outcomes of contraceptive use during last sex, unintended pregnancy and abortion and hence this highlighted the gaps of available evidence for these outcomes. The number of concepts, components, duration and providers of CSE varied across the included studies. However, none of the interventions identified in this scoping review adhered to the ITGSE recommended approach. CONCLUSIONS: Our scoping review shows gaps in school-based CSE implementation in terms of completeness of concepts, components, providers, duration and outcomes recommended by ITGSE.

Extracorporeal shock wave lithotripsy (ESWL) versus percutaneous nephrolithotomy (PCNL) or retrograde intrarenal surgery (RIRS) for kidney stones.

BACKGROUND: Nephrolithiasis is a common urological disease worldwide. Extracorporeal shock wave lithotripsy (ESWL) has been used for the treatment of renal stones since the 1980s, while retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PCNL) are newer, more invasive treatment modalities that may have higher stone-free rates. The complications of RIRS and PCNL have decreased owing to improvement in surgical techniques and instruments. We re-evaluated the best evidence on this topic in an update of a Cochrane Review first published in 2014. OBJECTIVES: To assess the effects of extracorporeal shock wave lithotripsy compared with percutaneous nephrolithotomy or retrograde intrarenal surgery for treating kidney stones. SEARCH METHODS: We performed a comprehensive search in CENTRAL, MEDLINE, Embase, and ClinicalTrials.gov with no restrictions on language or publication status. The latest search date was 6 December 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and quasi-RCTs that compared ESWL with PCNL or RIRS for kidney stone treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently classified studies, extracted data, and assessed risk of bias. Our primary outcomes were treatment success rate at three months (defined as residual fragments smaller than 4 mm, or as defined by the study authors), quality of life (QoL), and complications. Our secondary outcomes were retreatment rate, auxiliary procedures rate, and duration of hospital stay. We performed statistical analyses using a random-effects model and independently rated the certainty of evidence using the GRADE approach. MAIN RESULTS: We included 31 trials involving 3361 participants (3060 participants completed follow-up). Four trials were only available as an abstract. Overall mean age was 46.6 years and overall mean stone size was 13.4 mm. Most participants (93.8%) had kidney stones measuring 20 mm or less, and 68.9% had lower pole stones. ESWL versus PCNL ESWL may have a lower three-month treatment success rate than PCNL (risk ratio [RR] 0.67, 95% confidence interval [CI] 0.57 to 0.79; I2 = 87%; 12 studies, 1303 participants; low-certainty evidence). This corresponds to 304 fewer participants per 1000 (397 fewer to 194 fewer) reporting treatment success with ESWL. ESWL may have little or no effect on QoL after treatment compared with PCNL (1 study, 78 participants; low-certainty evidence). ESWL probably leads to fewer complications than PCNL (RR 0.62, 95% CI 0.47 to 0.82; I2 = 18%; 13 studies, 1385 participants; moderate-certainty evidence). This corresponds to 82 fewer participants per 1000 (115 fewer to 39 fewer) having complications after ESWL. ESWL versus RIRS ESWL may have a lower three-month treatment success rate than RIRS (RR 0.85, 95% CI 0.78 to 0.93; I2 = 63%; 13 studies, 1349 participants; low-certainty evidence). This corresponds to 127 fewer participants per 1000 (186 fewer to 59 fewer) reporting treatment success with ESWL. We are very uncertain about QoL after treatment; the evidence is based on three studies (214 participants) that we were unable to pool. We are very uncertain about the difference in complication rates between ESWL and RIRS (RR 0.93, 95% CI 0.63 to 1.36; I2 = 32%; 13 studies, 1305 participants; very low-certainty evidence). This corresponds to nine fewer participants per 1000 (49 fewer to 48 more) having complications after ESWL. AUTHORS' CONCLUSIONS: ESWL compared with PCNL may have lower three-month success rates, may have a similar effect on QoL, and probably leads to fewer complications. ESWL compared with RIRS may have lower three-month success rates, but the evidence on QoL outcomes and complication rates is very uncertain. These findings should provide valuable information to aid shared decision-making between clinicians and people with kidney stones who are undecided about these three options.

Incidence and prevalence of systemic sclerosis in Thailand in year 2017-2020: a database from the Ministry of Public Health.

BACKGROUND: A better understanding of the epidemiological profile of systemic sclerosis (SSc) in Thais could improve care, human resource deployment, and public health budgeting. OBJECTIVES: We aimed to determine the incidence and prevalence of SSc in Thailand between 2017 and 2020. METHODS: A descriptive epidemiological study was performed using the Information and Communication Technology Center, Ministry of Public Health database, comprising all types of healthcare providers during the study period. Demographic data of patients having a primary diagnosis of M34 systemic sclerosis and over 18 years of age between 2017 and 2020 were reviewed. The incidence and prevalence of SSc were calculated as well as their respective 95% confidence intervals (CIs). RESULTS: The number of SSc cases in 2017 was 15,920 from a total Thai population of 65,204,797. The prevalence of SSc in 2017 was 24.4 per 100,000 populations (95% CI 24.0-24.8). The prevalence of SSc among women was 2 times greater than among men (32.7 vs. 15.8 per 100,000). The incidence of SSc was stable from 2018 to 2019 but dropped slightly in 2020 (7.2, 7.6, and 6.8 per 100,000 person-years, respectively). Most SSc cases were in northeastern Thailand (11.6, 12.1, and 11.1 per 100,000 person-years from 2018 to 2020, respectively) and the peak was between 60 and 69 years of age (24.6, 23.8, and 20.9 per 100,000 person-years from 2018 to 2020, respectively). CONCLUSION: SSc is a rare disease among Thais. The disease was commonly revealed in late middle-aged women with a peak at age 60-69 years, mainly from the northeast regions. The incidence remained stable during the study period, albeit during the emergence of the coronavirus pandemic a slight decline was recorded. Key Points • The incidence and prevalence of systemic sclerosis (SSc) vary across ethnic populations. • There is a lack of epidemiology research of SSc since the 2013 ACR/EULAR Classification Criteria for Scleroderma was adopted among Thais included Asia-Pacific population as the population has some different clinical features than those reported among Caucasians. • SSc is a rare connective disease among Thais and commonly presents in late middle-aged group of both genders, mainly in Thailand's northern and northeastern regions. • When compare to the epidemiology of SSc in Asia-Pacific, the prevalence of SSc in Thais was higher than among East Asians and the Indian population and the incidence of SSc among Thais was greater than the other Asia-Pacific population including Australian.

Interventions to increase the uptake of cervical cancer screening in low- and middle-income countries: a systematic review and meta-analysis.

BACKGROUND: To identify effective interventions to increase the uptake of cervical cancer screening (CCS) for low-and middle-income countries (LMICs). METHODS: We searched PubMed, CENTRAL, ISI Web of Sciences, Scopus, OVID (Medline), CINAHL, LILACS, CNKI and OpenGrey for randomized controlled trials (RCTs) and cluster RCTs conducted in LMICs from January 2000 to September 2021. Two reviewers independently screened studies, extracted data, assessed risk of bias and certainty of evidence. Meta-analyses with random-effects models were conducted for data synthesis. RESULTS: We included 38 reports of 24 studies involving 318,423 participants from 15 RCTs and nine cluster RCTs. Single interventions may increase uptake of CCS when compared with control (RR 1.47, 95% CI 1.19 to 1.82). Self-sampling of Human Papillomavirus (HPV) testing may increase uptake of CCS relative to routine Visual Inspection with Acetic Acid (RR 1.93, 95% CI 1.66 to 2.25). Reminding with phone call may increase uptake of CCS than letter (RR 1.72, 95% CI 1.27 to 2.32) and SMS (RR 1.59, 95% CI 1.19 to 2.13). Sending 15 health messages may increase uptake of CCS relative to one SMS (RR 2.75, 95% CI 1.46 to 5.19). Free subsidized cost may increase uptake of CCS slightly than $0.66 subsidized cost (RR 1.60, 95% CI 1.10 to 2.33). Community based HPV test may increase uptake of CCS slightly in compared to hospital collected HPV (RR 1.67, 95% CI 1.53 to 1.82). The evidence is very uncertain about the effect of combined interventions on CCS uptake relative to single intervention (RR 2.20, 95% CI 1.54 to 3.14). CONCLUSIONS: Single interventions including reminding with phone call, SMS, community self-sampling of HPV test, and free subsidized services may enhance CCS uptake. Combined interventions, including health education interventions and SMS plus e-voucher, may be better than single intervention. Due to low-certainty evidences, these findings should be applied cautiously.

Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception.

BACKGROUND: Long-acting reversible contraception (LARC), including intrauterine devices (IUDs) and contraceptive implants, are highly effective, reversible methods of contraception. Providing LARC methods during the postpartum period is important to support contraceptive choice, and to prevent unintended pregnancy and short interpregnancy intervals. Delaying offering contraception to postpartum people until the first comprehensive postpartum visit, traditionally at around six weeks postpartum, may put some postpartum people at risk of unintended pregnancy, either due to loss to follow-up or because of initiation of sexual intercourse prior to receiving contraception. Therefore, immediate provision of highly effective contraception, prior to discharge from hospital, has the potential to improve contraceptive use and prevent unintended pregnancies and short interpregnancy intervals. OBJECTIVES: To compare the initiation rate, utilization rates (at six months and 12 months after delivery), effectiveness, and adverse effects of immediate versus delayed postpartum insertion of implants and IUDs for contraception. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and POPLINE for eligible studies up to December 2020. We examined review articles and contacted investigators. We checked registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies. SELECTION CRITERIA: We sought randomized controlled trials (RCTs) that compared immediate postpartum versus delayed insertion of contraceptive implant and IUDs for contraception. DATA COLLECTION AND ANALYSIS: Two review authors (JS, SK) independently screened titles and abstracts of the search results, and assessed the full-text articles of potentially relevant studies for inclusion. They extracted data from the included studies, assessed risk of bias, compared results, and resolved disagreements by consulting a third review author (PL, SA or PP). We contacted investigators for additional data, where possible. We computed the Mantel-Haenszel or inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes and the mean difference (MD) with 95% CI for continuous variables. MAIN RESULTS: In this updated review, 16 studies met the inclusion criteria; five were studies of contraceptive implants (715 participants) and 11 were studies of IUDs (1894 participants). We identified 12 ongoing studies. We applied GRADE judgements to our results; the overall certainty of the evidence for each outcome ranged from moderate to very low, with the main limitations being risk of bias, inconsistency, and imprecision. Contraceptive implants Immediate insertion probably improves the initiation rate for contraceptive implants compared with delayed insertion (RR 1.48, 95% CI 1.11 to 1.98; 5 studies, 715 participants; I2 = 95%; moderate-certainty evidence). We are uncertain if there was a difference between the two groups for the utilization rate of contraceptive implants at six months after delivery (RR 1.16, 95% CI 0.90 to 1.50; 3 studies, 330 participants; I2 = 89%; very low-certainty evidence) or at 12 months after insertion (RR 0.98, 95% CI 0.93 to 1.04; 2 studies, 164 participants; I2 = 0%; very low-certainty evidence). People who received an immediate postpartum contraceptive implant insertion may have had a higher mean number of days of prolonged vaginal bleeding within six weeks postpartum (mean difference (MD) 2.98 days, 95% CI -2.71 to 8.66; 2 studies, 420 participants; I2 = 91%; low-certainty evidence) and a higher rate of other adverse effects in the first six weeks after birth (RR 2.06, 95% CI 1.38 to 3.06; 1 study, 215 participants; low-certainty evidence) than those who received a delayed postpartum insertion. We are uncertain if there was a difference between the two groups for prolonged bleeding at six months after delivery (RR 1.19, 95% CI 0.29 to 4.94; 2 studies, 252 participants; I2 = 0%; very low-certainty evidence). There may be little or no difference between the two groups for rates of unintended pregnancy at six months (RR 0.20, 95% CI 0.01 to 4.08; one study, 205 participants; low-certainty evidence). We are uncertain whether there was a difference in rates of unintended pregnancy at 12 months postpartum (RR 1.82, 95% CI 0.38 to 8.71; 1 study, 64 participants; very low-certainty evidence). There may be little or no difference between the two groups for any breastfeeding rates at six months (RR 0.97, 95% CI 0.92 to 1.01; 2 studies, 225 participants; I2 = 48%; low-certainty evidence). IUDs Immediate insertion of IUDs probably improves the initiation rate compared with delayed insertion, regardless of type of IUD (RR 1.27, 95% CI 1.07 to 1.51; 10 studies, 1894 participants; I2 = 98%; moderate-certainty evidence). However, people who received an immediate postpartum IUD insertion may have had a higher expulsion rate at six months after delivery (RR 4.55, 95% CI 2.52 to 8.19; 8 studies, 1206 participants; I2 = 31%; low-certainty evidence) than those who received a delayed postpartum insertion. We are uncertain if there was a difference between the two groups in the utilization of IUDs at six months after insertion (RR 1.02, 95% CI 0.65 to 1.62; 6 studies, 971 participants; I2 = 96%; very low-certainty evidence) or at 12 months after insertion (RR 0.86, 95% CI 0.5 to 1.47; 3 studies, 796 participants; I2 = 92%; very low-certainty evidence). Immediate IUDs insertion may reduce unintended pregnancy at 12 months (RR 0.26, 95% CI 0.17 to 0.41; 1 study, 1000 participants; low-certainty evidence). We are uncertain whether there was difference in any breastfeeding rates at six months in people receiving progestin-releasing IUDs (RR 0.90, 95% CI 0.63 to 1.30; 5 studies, 435 participants; I2 = 54%; very low-certainty evidence). AUTHORS' CONCLUSIONS: Evidence from this updated review indicates that immediate postpartum insertion improves the initiation rate of both contraceptive implants and IUDs by the first postpartum visit compared to delayed insertion. However, it is not clear whether that there are differences in utilization rates at six and 12 months postpartum. We are uncertain whether there is any difference in the unintended pregnancy rate at 12 months. Provision of progestin-releasing implants and IUDs immediately postpartum may have little or no negative impact on breastfeeding. However, the expulsion rate of IUDs and prolonged vaginal bleeding associated with immediate implants appears to be higher.

Early-onset neonatal sepsis and antibiotic use in Indonesia: a descriptive, cross-sectional study.

BACKGROUND: Early diagnosis and prompt antibiotic treatment are crucial to reducing morbidity and mortality of early-onset sepsis (EOS) in neonates. However, this strategy remains challenging due to non-specific clinical findings and limited facilities. Inappropriate antibiotics use is associated with ineffective therapy and adverse outcomes. This study aims to determine the characteristics of EOS and use of antibiotics in the neonatal-intensive care units (NICUs) in Indonesia, informing efforts to drive improvements in the prevention, diagnosis, and treatment of EOS. METHODS: A descriptive study was conducted based on pre-intervention data of the South East Asia-Using Research for Change in Hospital-acquired Infection in Neonates project. Our study population consisted of neonates admitted within 72 h of life to the three participating NICUs. Neonates who presented with three or more clinical signs or laboratory results consistent with sepsis and who received antibiotics for 5 consecutive days were considered to have EOS. Culture-proven EOS was defined as positive blood or cerebrospinal fluid culture. Type and duration of antibiotics used were also documented. RESULTS: Of 2,509 neonates, 242 cases were suspected of having EOS (9.6%) with culture-proven sepsis in 83 cases (5.0% of neonatal admissions in hospitals with culture facilities). The causative organisms were mostly gram-negative bacteria (85/94; 90.4%). Ampicillin / amoxicillin and amikacin were the most frequently prescribed antibiotics in hospitals with culture facilities, while a third-generation cephalosporin was mostly administered in hospital without culture facilities. The median durations of antibiotic therapy were 19 and 9 days in culture-proven and culture-negative EOS groups, respectively. CONCLUSIONS: The overall incidence of EOS and culture-proven EOS was high in Indonesia, with diverse and prolonged use of antibiotics. Prospective antibiotic surveillance and stewardship interventions are required.

Roselle for hypertension in adults.

BACKGROUND: Hypertension is considered to be a serious health problem worldwide. Controlling and lowering blood pressure are of significant benefit to people with hypertension because hypertension is a risk factor for stroke, heart disease, and cardiovascular disease. Roselle, the tropical plant Hibiscus sabdariffa, also commonly called sour tea or red tea, has been used as both a thirst-quenching drink and for medicinal purposes. OBJECTIVES: To assess the effect of Roselle on blood pressure in people with primary hypertension. SEARCH METHODS: For this update, the Cochrane Hypertension Information Specialist searched the following databases and trials registers for randomised controlled trials (RCTs): the Cochrane Hypertension Specialised Register (to 6 August 2021), Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 7), MEDLINE Ovid (1946 to 5 August 2021), Embase Ovid (1974 to 5 August 2021), ProQuest Dissertations & Theses (to 6 August 2021), Web of Science Clarivate (to 7 August 2021), Food Science and Technology Abstracts Clarivate (to 7 August 2021), the WHO International Clinical Trials Registry Platform (to 6 August 2021), and the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (to 6 August 2021). We searched Google Scholar and OpenSIGLE. We also handsearched local and regional Chinese databases: CBM, CMCC, TCMLARS, CNKI, CMAC, and the Index to Chinese Periodical Literature (to 14 September 2020), as well as Thai databases (ThaiJO, CUIR, TDC, CMU e-Theses, TCTR) (to 3 October 2020). There were no language or publication date restrictions. SELECTION CRITERIA: We sought RCTs evaluating the use of any forms of Roselle with placebo or no treatment in adults with hypertension. Our primary outcome was change in trough and/or peak systolic and diastolic blood pressure (SBP, DBP). Secondary outcomes were withdrawals due to adverse effects, change in pulse pressure, and change in heart rate. DATA COLLECTION AND ANALYSIS: All search results were managed using Covidence and re-checked for the number of records, inclusion and exclusion of studies with Mendeley reference management software. We used standard methodological procedures expected by Cochrane. Two review authors worked independently in parallel for screening (titles and abstracts, and full reports), data extraction, risk of bias assessment, and assessment of the certainty of the evidence using the GRADE approach. Any disagreements were resolved by discussion or by consultation with the third review author if necessary. We presented mean difference (MD) of change in SBP and DBP with their corresponding 95% confidence interval (CI). MAIN RESULTS: For this update, only one RCT with a parallel-group design involving 60 participants with type 2 diabetes mellitus fulfilled the inclusion criteria. This study investigated the effect of Roselle extract capsules (total dose of 5600 mg) compared with placebo (lactose) at eight weeks. The study was at low risk of selection bias, performance bias, and detection bias. Conversely, it was at high risk of attrition bias, reporting bias, and other bias (baseline imbalance). We have very little confidence in the effect estimate of Roselle on change-from-baseline in both SBP and DBP between the two groups. The MD of change in SBP was 1.65, 95% CI -7.89 to 11.19 mmHg, 52 participants, very low-certainty evidence. The MD of change in DBP was 4.60, 95% CI -1.38 to 10.58 mmHg, 52 participants, very low-certainty evidence. Our secondary outcomes of withdrawals due to adverse effects, change in pulse pressure, and change in heart rate were not reported. Due to the limited available data, no secondary analyses were performed (subgroup and sensitivity analysis). AUTHORS' CONCLUSIONS: The evidence is currently insufficient to determine the effectiveness of Roselle compared to placebo for controlling or lowering blood pressure in people with hypertension. The certainty of evidence was very low due to methodological limitations, imprecision, and indirectness. There is a need for rigorous RCTs that address the review question.

Postoperative adjuvant chemotherapy for resectable cholangiocarcinoma.

BACKGROUND: Cholangiocarcinoma (cancer in the bile duct) is an aggressive tumour for which surgical resection is a mainstay of treatment. Despite complete resection, recurrences of the cancer are common and lead to poor prognosis in patients. Postoperative adjuvant chemotherapy given after surgical resection may reduce the risk of cancer recurrence by eradicating residual cancer and micrometastatic lesions. The benefits and harms of postoperative adjuvant chemotherapy versus placebo, no intervention, or other adjuvant chemotherapies are unclear. OBJECTIVES: To assess the benefits and harms of postoperative adjuvant chemotherapy versus placebo, no intervention, or other adjuvant chemotherapies for people with cholangiocarcinoma after curative-intent resection. SEARCH METHODS: We performed electronic searches in the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index - Science for trials that met the inclusion criteria up to 28 April 2021. SELECTION CRITERIA: Randomised clinical trials irrespective of blinding, publication status, or language comparing postoperative adjuvant chemotherapy versus placebo, no intervention, or a different postoperative adjuvant chemotherapy regimen for participants with curative-intent resection for cholangiocarcinoma. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods to develop and conduct the review. We conducted meta-analyses and presented results, where feasible, using a random-effects model and risk ratios (RR) with 95% confidence intervals (CI). We assessed risk of bias according to predefined domains suggested by Cochrane. We rated the certainty of evidence using the GRADE approach and presented outcome results in a summary of findings table. MAIN RESULTS: We included five published randomised clinical trials. The trials included 931 adults (18 to 83 years old) who underwent curative-intent resection for cholangiocarcinoma. Four trials compared postoperative adjuvant chemotherapy (mitomycin-C and 5-fluorouracil (5-FU); gemcitabine; gemcitabine plus oxaliplatin; or capecitabine) versus no postoperative adjuvant chemotherapy (surgery alone) in 867 participants with cholangiocarcinoma only. A fifth trial compared postoperative adjuvant S-1 (a novel oral fluoropyrimidine derivative) chemotherapy versus gemcitabine in 70 participants with intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma (64 participants), and gallbladder carcinoma (6 participants). We assessed all of the included trials at overall high risk of bias. One trial was conducted in France, three in Japan, and one in the United Kingdom. We could not perform all planned comparison analyses due to lack of data. Three trials used intention-to-treat analyses. Another trial used per-protocol analysis. In the remaining trial one participant in the intervention group and one in the control group were lost to follow-up. However, the outcomes of these two participants were not described. Postoperative adjuvant chemotherapy versus no postoperative adjuvant chemotherapy We are very uncertain as to whether postoperative adjuvant chemotherapy has little to no effect on all-cause mortality versus no postoperative adjuvant chemotherapy (RR 0.92, 95% CI 0.84 to 1.01; 4 trials, 867 participants, very low-certainty evidence). We are very uncertain of the effect of postoperative adjuvant chemotherapy on serious adverse events (RR 17.82, 95% CI 2.43 to 130.82; 1 trial, 219 participants, very low-certainty evidence). The trial indicated that postoperative adjuvant chemotherapy could increase serious adverse events, as 19/113 (20.5%) of participants developed an adverse event, compared to 1/106 (1.1%) of participants in the no-postoperative adjuvant chemotherapy group. None of the included trials reported data on health-related quality of life, cancer-related mortality, time to recurrence of the tumour, and non-serious adverse events in participants with only cholangiocarcinoma. Adjuvant S-1 chemotherapy (fluoropyrimidine derivative) versus adjuvant gemcitabine-based chemotherapy The only available trial analysed all participants with intrahepatic, perihilar cholangiocarcinoma and gallbladder carcinoma together, with data on participants with cholangiocarcinoma not provided separately. The authors reported that one-year overall mortality after adjuvant S-1 therapy was lower than with adjuvant gemcitabine-based therapy following major hepatectomy for biliary tract cancer. There were no differences in two-year overall mortality. FUNDING: two trials received support from drug companies; one trial received funding from the Japan Society of Clinical Oncology; one trial received support from "Programme Hospitalier de Recherche Clinique (PHRC2009) and Ligue Nationale Contre le Cancer"; and one trial did not provide information on support or sponsorship. We identified six ongoing randomised clinical trials. AUTHORS' CONCLUSIONS: Based on the very low-certainty evidence found in four trials in people with curative-intent resection for cholangiocarcinoma, we are very uncertain of the effects of postoperative adjuvant chemotherapy (mitomycin-C and 5-FU; gemcitabine; gemcitabine plus oxaliplatin; or capecitabine) versus no postoperative adjuvant chemotherapy on mortality. The effects of postoperative adjuvant chemotherapy compared with no postoperative adjuvant chemotherapy on serious adverse events are also very uncertain, but the result of the single trial showed 20% higher occurrences of haematologic adverse events. We assessed the certainty of the evidence as very low due to overall high risk of bias, and imprecision. Due to insufficient power of the only identified trial, the best postoperative adjuvant chemotherapy regimen in people with only cholangiocarcinoma could not be established. We also lack randomised clinical trials with outcome data on adjuvant S-1 chemotherapy versus adjuvant gemcitabine-based chemotherapy in people with cholangiocarcinoma alone. There is a need for further randomised clinical trials designed to be at low risk of bias and with adequate sample size exploring the best adjuvant chemotherapy treatment after surgery in people with cholangiocarcinoma.

Women's experiences of mistreatment during childbirth and their satisfaction with care: findings from a multicountry community-based study in four countries.

INTRODUCTION: Experiences of care and satisfaction are intrinsically linked, as user's experiences of care may directly impact satisfaction, or indirectly impact user's expectations and values. Both experiences of care and satisfaction are important to measure so that quality can be monitored and improved. Globally, women experience mistreatment during childbirth at facilities; however, there is limited evidence exploring the mistreatment and women's satisfaction with care during childbirth. METHODS: This is a secondary analysis of a cross-sectional survey within the WHO study 'How women are treated during facility-based childbirth' exploring the mistreatment of women during childbirth in Ghana, Guinea, Myanmar and Nigeria. Women's experiences of mistreatment and satisfaction with care during childbirth was explored. Multivariable logistic regression modelling was conducted to evaluate the association between mistreatment, women's overall satisfaction with the care they received, and whether they would recommend the facility to others. RESULTS: 2672 women were included in this analysis. Despite over one-third of women reporting experience of mistreatment (35.4%), overall satisfaction for services received and recommendation of the facility to others was high, 88.4% and 90%, respectively. Women who reported experiences of mistreatment were more likely to report lower satisfaction with care: women were more likely to be satisfied if they did not experience verbal abuse (adjusted OR (AOR) 4.52, 95% CI 3.50 to 5.85), or had short waiting times (AOR 5.12, 95% CI 3.94 to 6.65). Women who did not experience any physical or verbal abuse or discrimination were more likely to recommend the facility to others (AOR 3.89, 95% CI 2.98 to 5.06). CONCLUSION: Measuring both women's experiences and their satisfaction with care are critical to assess quality and provide actionable evidence for quality improvement. These measures can enable health systems to identify and respond to root causes contributing to measures of satisfaction.

Progestogens or progestogen-releasing intrauterine systems for uterine fibroids (other than preoperative medical therapy).

BACKGROUND: Uterine fibroids can cause heavy menstrual bleeding. Medical treatments are considered to preserve fertility. It is unclear whether progestogens or progestogen-releasing intrauterine systems can reduce fibroid-related symptoms. This is the first update of a Cochrane Review published in 2013. OBJECTIVES: To determine the effectiveness of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, and PsycINFO databases to July 2020. We also searched trials registers for ongoing and registered trials, and checked references of relevant trials. SELECTION CRITERIA: All identified published or unpublished randomised controlled trials (RCTs) assessing the effect of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data, assessed risk of bias, and assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: This updated review included four studies with 221 women with uterine fibroids. The evidence was very low quality, downgraded for serious risk of bias, due to poor reporting of study methods, and serious imprecision. Levonorgestrel-releasing intrauterine device (LNG-IUS) versus hysterectomy There was no information on the outcomes of interest, including adverse events. LNG-IUS versus low dose combined oral contraceptive (COC) At 12 months, we are uncertain whether LNG-IUS reduced the percentage of abnormal uterine bleeding, measured with the alkaline hematin test (mean difference (MD) 77.50%, 95% confidence interval (CI) 70.44 to 84.56; 1 RCT, 44 women; very low-quality evidence), or the pictorial blood assessment chart (PBAC; MD 34.50%, 95% CI 11.59 to 57.41; 1 RCT, 44 women; very low-quality evidence); increased haemoglobin levels (MD 1.50 g/dL, 95% CI 0.85 to 2.15; 1 RCT, 44 women; very low-quality evidence), or reduced fibroid size more than COC (MD 1.90%, 95% CI -12.24 to 16.04; 1 RCT, 44 women; very low-quality evidence). The study did not measure adverse events. LNG-IUS versus oral progestogen (norethisterone acetate (NETA)) Compared to NETA, we are uncertain whether LNG-IUS reduced abnormal uterine bleeding more from baseline to six months (visual bleeding score; MD 23.75 points, 95% CI 1.26 to 46.24; 1 RCT, 45 women; very low-quality evidence); increased the percentage of change in haemoglobin from baseline to three months (MD 4.53%, 95% CI 1.46 to 7.60; 1 RCT, 48 women; very low-quality evidence), or from baseline to six months (MD 10.14%, 95% CI 5.57 to 14.71; 1 RCT, 45 women; very low-quality evidence). The study did not measure fibroid size. Spotting (adverse event) was more likely to be reported by women with the LNG-IUS (64.3%) than by those taking NETA (30%; 1 RCT, 45 women; very low-quality evidence). Oral progestogen (dienogest, desogestrel) versus goserelin acetate Compared to goserelin acetate, we are uncertain whether abnormal uterine bleeding was reduced at 12 weeks with dienogest (PBAC; MD 216.00 points, 95% CI 149.35 to 282.65; 1 RCT, 14 women; very low-quality evidence) or desogestrel (PBAC; MD 78.00 points, 95% CI 28.94 to 127.06; 1 RCT, 16 women; very low-quality evidence). Vasomotor symptoms (adverse events, e.g. hot flashes) are only associated with goserelin acetate (55%), not with dienogest (1 RCT, 14 women; very low-quality evidence) or with desogestrel (1 RCT, 16 women; very low-quality evidence). The study did not report fibroid size. AUTHORS' CONCLUSIONS: Because of very low-quality evidence, we are uncertain whether the LNG-IUS reduces abnormal uterine bleeding or increases haemoglobin levels in premenopausal women with uterine fibroids, compared to COC or norethisterone acetate. There was insufficient evidence to determine whether the LNG-IUS reduces the size of uterine fibroids compared to COC. We are uncertain whether oral progestogens reduce abnormal uterine bleeding as effectively as goserelin acetate, but women reported fewer adverse events, such as hot flashes.

Health education interventions to promote early presentation and referral for women with symptoms of endometrial cancer.

BACKGROUND: Diagnosis of endometrial (womb) cancer is normally made at an early stage, as most women with the disease experience abnormal vaginal bleeding, which prompts them to seek medical advice. However, delays in presentation and referral can result in delay in diagnosis and management, which can lead to unfavourable treatment outcomes. This is particularly a problem for pre- and peri-menopausal women. Providing educational information to women and healthcare providers regarding symptoms relating to endometrial cancer may raise awareness of the disease and reduce delayed treatment. OBJECTIVES: To assess the effectiveness of health education interventions targeting healthcare providers, or individuals, or both, to promote early presentation and referral for women with endometrial cancer symptoms. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles. SELECTION CRITERIA: We planned to include randomised controlled trials (RCTs), both individually randomised and cluster-RCTs. In the absence of RCTs we planned to include well-designed non-randomised studies (NRS) with a parallel comparison assessing the benefits of any type of health education interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently evaluated whether potentially relevant studies met the inclusion criteria for the review, but none were found. MAIN RESULTS: A comprehensive search of the literature yielded the following results: CENTRAL (1022 references), MEDLINE (2874 references), and Embase (2820 references). After de-duplication, we screened titles and abstracts of 4880 references and excluded 4864 that did not meet the review inclusion criteria. Of the 16 references that potentially met the review inclusion, we excluded all 16 reports after reviewing the full texts. We did not identify any ongoing trials. AUTHORS' CONCLUSIONS: There is currently an absence of evidence to indicate the effectiveness of health education interventions involving healthcare providers or individuals or both to promote early presentation and referral for women with endometrial cancer symptoms. High-quality RCTs are needed to assess whether health education interventions enhance early presentation and referral. If health education interventions can be shown to reduce treatment delays in endometrial cancer, further studies would be required to determine which interventions are most effective.

One- to 10-year Status Epilepticus Mortality (SEM) score after 30 days of hospital discharge: development and validation using competing risks analysis.

BACKGROUND: Status epilepticus (SE) is an emergency neurological disorder that affects quality of life and is associated with high mortality risk. Three scores have been developed to predict the risk of in-hospital death, but these scores are poor discrimination of mortality after discharge. This study aimed to develop and validate a simple risk score for long-term mortality in SE patients. METHODS: This retrospective cohort study was conducted using SE patient data collected from Thailand's Universal Coverage Scheme database between the fiscal years of 2005 and 2015 and followed-up to 2016. Patients who died in hospital or within 30 days after discharge were excluded. Data were divided at random into either a derivation or validation set. A proportional hazards model for the sub-distribution of competing risks was fitted with backward stepwise method. The coefficients from the model were used to develop a point-based scoring system. The discrimination ability of the model was evaluated using a time-dependent receiver operating characteristic (ROC) curve. RESULTS: A total of 20,792 SE patients (with ages ranging from the first day of life to 99 years at first admission) were randomly separated into two groups: 13,910 in the development group and 6882 in the validation group. A sub-distribution hazard model was used to determine nine predictors to be included in the final model, which was, in turn, used to develop the scoring system: age (0-19 points), male (two points), brain tumor (12 points), stroke (three points), cancer (11 points), diabetes (three points), chronic kidney disease (five points), pneumonia (five points), and urinary tract infection (four points). The possible total score ranged from zero to 64 and the cumulative incidence function was used to determine the probability of mortality associated with each total score within the first 10 years after the first admission. The area under the ROC curve (AUC) of the first to last time point ranged from 0.760 to 0.738. CONCLUSION: A nine-factor risk score for predicting 10-year mortality in SE patients was developed. Further studies should focus on external validity and including a range seizure types and duration of seizure as the predictors.

Mode of delivery and pregnancy outcomes in preterm birth: a secondary analysis of the WHO Global and Multi-country Surveys.

Many studies have been conducted to examine whether Caesarean Section (CS) or vaginal birth (VB) was optimal for better maternal and neonatal outcomes in preterm births. However, findings remain unclear. Therefore, this secondary analysis of World Health Organization Global Survey (GS) and Multi-country Survey (MCS) databases was conducted to investigate outcomes of preterm birth by mode of delivery. Our sample were women with singleton neonates (15,471 of 237 facilities from 21 countries in GS; and 15,053 of 239 facilities from 21 countries in MCS) delivered between 22 and <37 weeks of gestation. We assessed association between mode of delivery and pregnancy outcomes in singleton preterm births by multilevel logistic regression adjusted for hierarchical data. The prevalences of women with preterm birth delivered by CS were 31.0% and 36.7% in GS and MCS, respectively. Compared with VB, CS was associated with significantly increased odds of maternal intensive care unit admission, maternal near miss, and neonatal intensive care unit admission but significantly decreased odds of fresh stillbirth, and perinatal death. However, since the information on justification for mode of delivery (MOD) were not available, our results of the potential benefits and harms of CS should be carefully considered when deciding MOD in preterm births.

Causes of death in patients with status epilepticus.

BACKGROUND: Status epilepticus (SE) is a neurological disorder that affects to the high mortality risk. Several studies reported predictors of mortality in SE; actual causes of death in hospital and out of hospital are limited. This study aimed to describe the case fatality and the causes of death in patients with SE. METHODS: This was a descriptive study using the data collected in the national data of the Universal Coverage Scheme in Thailand during the fiscal year 2005 to 2015. Patients who admitted to hospitals and diagnosed as SE were included. The vital status of patients with SE was linked with the Ministry of the Interior and was classified into three phases: in-hospital, short-term, and long-term. RESULTS: Among 24,802 patients with SE, 1861 (7.5%) died in hospital, 1910 (7.7%) died within 30 days after hospital discharge, and 4906 (19.8%) died after 30 days. In-hospital death, SE complications (45.9%), seizure (19.6%), and comorbidities (15.4%) were the three common causes of death. While the common causes in short-term and long-term mortality were SE complications (27.7% and 31.0%), comorbidities (28.1% and 26.7%), and other causes (22.4% and 21.9%). CONCLUSION: Status epilepticus complications and comorbidities were the common cause of death in patients with SE for all of three periods. This article is part of the Special Issue "Proceedings of the 7th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures".

Early-Onset Neonatal Sepsis and Antibiotic Use in Northeast Thailand.

OBJECTIVE: Antibiotics are commonly prescribed in neonatal intensive care units (NICUs) for suspected sepsis because of the nonspecific clinical symptoms of sepsis. The overuse of antibiotic is associated with adverse outcomes. This study aimed to determine the rate of early-onset sepsis (EOS) and antibiotic use in neonates admitted to three NICUs in Northeast Thailand STUDY DESIGN: This is a descriptive study using the data collected in the South East Asia-Using Research for Change in Hospital-acquired Infection in Neonates project. Neonates admitted within 3 days of life were included. EOS was defined as neonates who presented with three or more clinical signs or laboratory results suggested sepsis and received antibiotics for at least 5 days. Those with positive blood culture were culture-proven EOS. Antibiotic use within 3 days of life and up to 28 days was described. RESULTS: Among 1,897 neonates, 160 cases were classified as EOS (8.4%) with culture-proven EOS in 4 cases (0.2%). The median durations of antibiotic use in culture-proven and culture-negative EOSs were 15 and 8 days, respectively. CONCLUSION: The rate of culture-proven EOS was low, but there was a high rate of antibiotic use. Antibiotic stewardship should be emphasized.

Perioperative Complications of Hysterectomy After a Previous Cesarean Section: A Systematic Review and Meta-Analysis.

BACKGROUND: With increasing rates of cesarean sections (CS), the number of hysterectomies performed among women with a previous CS is on the rise. OBJECTIVE: To provide the association between the odds of complications following a hysterectomy performed later in life and a previous CS. SEARCH STRATEGY: A comprehensive search was performed using major electronic databases, ie, MEDLINE, Scopus, ISI Web of Science, from their inception to April 2019. SELECTION CRITERIA: Analytical studies, irrespective of language or publication status, were included. DATA COLLECTION AND ANALYSIS: Outcomes were extracted in duplicate. The methodological quality of the included studies was independently evaluated by two review authors. A three-level meta-analysis was applied for outcomes with dependent effect sizes. MAIN RESULTS: Twenty-six studies were included involving 54,815 women. The odds of the following complications were increased in women with a previous CS: urinary tract injury (pooled unadjusted odds ratio (OR)=3.15, 95% CI=2.01-4.94, 15 studies, 33,902 women, and pooled adjusted OR=2.21, 95% CI=1.46-3.34, 3 studies, 31,038 women), gastrointestinal tract injury (pooled unadjusted OR=1.73, 95% CI=1.19-2.53; 7 studies, 30,050, and pooled adjusted OR=1.83, 95% CI=1.11-3.03, 1 study, 25,354 women), postoperative infections (pooled unadjusted OR=1.44, 95% CI=1.22-1.71, 6 studies, 37,832 women), wound complications (pooled unadjusted OR=2.24, 95% CI=1.94-2.57, 9 studies, 37,559 women), reoperation (pooled unadjusted OR=1.46, 95% CI=1.19-1.78, 2 studies, 9,899 women), and blood transfusion (pooled unadjusted OR=1.35, 95% CI=1.03-1.76, 7 studies, 13,430 women). CONCLUSION: Previous CS increases risks of various complications following hysterectomy. This information reminds the gynecologists to be aware of the associations between previous CS and potential complications among women undergoing hysterectomy. PROSPERO REGISTRATION NUMBER: CRD42018085061.

Extended-field radiotherapy for locally advanced cervical cancer.

BACKGROUND: The para-aortic lymph nodes (located along the major vessels in the mid and upper abdomen) are a common place for disease recurrence after treatment for locally advanced cervical cancer. The para-aortic area is not covered by standard pelvic radiotherapy fields and so treatment to the pelvis alone is inadequate for women at a high risk of occult cancer within para-aortic lymph nodes. Extended-field radiotherapy (RT) widens the pelvic RT field to include the para-aortic lymph node area. Extended-field RT may improve outcomes in women with locally advanced cervical cancer by treating occult disease in para-aortic nodes not identified at pretreatment imaging. However, RT treatment of the para-aortic area can cause severe adverse effects, so may increase harms.Studies of pelvic chemoradiotherapy (CRT) demonstrated improved survival rates compared to pelvic RT alone. CRT is now the standard of care in the treatment of locally advanced cervical cancer. Studies comparing pelvic RT alone (without concurrent chemotherapy) with extended-field RT should therefore be viewed with caution, since they compare treatments against what is now substandard treatment (pelvic RT alone). This review should therefore be read with this in mind and comparisons with pelvic RT cannot be extrapolated to pelvic CRT. OBJECTIVES: To evaluate the effectiveness and toxicity of extended-field radiotherapy in women undergoing first-line treatment for locally advanced cervical cancer. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), MEDLINE via Ovid (1946 to August week 4, 2018), and Embase via Ovid (1980 to 2018, week 35). We checked registers of clinical trials, grey literature, conference reports, and citation lists of included studies to August 2018. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the effectiveness and toxicity of extended-field RT for locally advanced cervical cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently selected potentially relevant RCTs, extracted data, assessed risk of bias, compared results, and made judgements on the quality and certainty of the evidence for each outcome. Any disagreements were resolved by discussion or consultation with a third review author. MAIN RESULTS: Five studies met the inclusion criteria. Three included studies compared extended-field RT versus pelvic RT, one included study compared extended-field RT with pelvic CRT, and one study compared extended-field CRT versus pelvic CRT.Extended-field radiotherapy versus pelvic radiotherapy aloneCompared to pelvic RT, extended-field RT probably reduces the risk of death (hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.48 to 0.94; 1 study; 337 participants; moderate-certainty evidence) and para-aortic lymph node recurrence (risk ratio (RR) 0.36, 95% CI 0.18 to 0.70; 2 studies; 477 participants; moderate-certainty evidence), although there may or may not have been improvement in the risk of disease progression (HR 0.92, 95% CI 0.69 to 1.22; 1 study; 337 participants; moderate-certainty evidence) and severe adverse events (RR 1.05, 95% CI 0.79 to 1.41; 2 studies; 776 participants; moderate-certainty evidence).Extended-field radiotherapy versus pelvic chemoradiotherapyIn a comparison of extended-field RT versus pelvic CRT, women given pelvic CRT probably had a lower risk of death (HR 0.50, 95% CI 0.39 to 0.64; 1 study; 389 participants; moderate-certainty evidence) and disease progression (HR 0.52, 95% CI 0.37 to 0.72; 1 study; 389 participants; moderate-certainty evidence). Participants given extended-field RT may or may not have had a lower risk of para-aortic lymph node recurrence (HR 0.44, 95% CI 0.20 to 0.99; 1 study; 389 participants; low-certainty evidence) and acute severe adverse events (RR 0.05, 95% CI 0.02 to 0.11; 1 study; 388 participants; moderate-certainty evidence). There were no clear differences in terms of late severe adverse events among the comparison groups (RR 1.06, 95% CI 0.69 to 1.62; 1 study; 386 participants; moderate-certainty evidence).Extended-field chemoradiotherapy versus pelvic chemoradiotherapyVery low-certainty evidence obtained from one small study (74 participants) showed that, compared to pelvic CRT, extended-field CRT may or may not have reduced risk of death (HR 0.37, 95% CI 0.14 to 0.96) and disease progression (HR 0.25, 95% CI 0.07 to 0.87). There were no clear differences between the groups in the risks of para-aortic lymph node recurrence (RR 0.19, 95% CI 0.02 to 1.54; very low-certainty evidence) and severe adverse events (acute: RR 0.95, 95% CI 0.20 to 4.39; late: RR 0.95, 95% CI 0.06 to 14.59; very low-certainty evidence). AUTHORS' CONCLUSIONS: Moderate-certainty evidence shows that, compared with pelvic RT alone, extended-field RT probably improves overall survival and reduces risk of para-aortic lymph node recurrence. However, pelvic RT alone would now be considered substandard treatment, so this result cannot be extrapolated to modern standards of care. Low- to moderate-certainty evidence suggests that pelvic CRT may increase overall and progression-free survival compared to extended-field RT, although there may or may not be a higher rate of para-aortic recurrence and acute adverse events. Extended-field CRT versus pelvic CRT may improve overall or progression-free survival, but these findings should be interpreted with caution due to very low-certainty evidence.High-quality RCTs, comparing modern treatment techniques in CRT, are needed to more fully inform treatment for locally advanced cervical cancer without obvious para-aortic node involvement.

Prognostic models for complete recovery in ischemic stroke: a systematic review and meta-analysis.

BACKGROUND: Prognostic models have been increasingly developed to predict complete recovery in ischemic stroke. However, questions arise about the performance characteristics of these models. The aim of this study was to systematically review and synthesize performance of existing prognostic models for complete recovery in ischemic stroke. METHODS: We searched journal publications indexed in PUBMED, SCOPUS, CENTRAL, ISI Web of Science and OVID MEDLINE from inception until 4 December, 2017, for studies designed to develop and/or validate prognostic models for predicting complete recovery in ischemic stroke patients. Two reviewers independently examined titles and abstracts, and assessed whether each study met the pre-defined inclusion criteria and also independently extracted information about model development and performance. We evaluated validation of the models by medians of the area under the receiver operating characteristic curve (AUC) or c-statistic and calibration performance. We used a random-effects meta-analysis to pool AUC values. RESULTS: We included 10 studies with 23 models developed from elderly patients with a moderately severe ischemic stroke, mainly in three high income countries. Sample sizes for each study ranged from 75 to 4441. Logistic regression was the only analytical strategy used to develop the models. The number of various predictors varied from one to 11. Internal validation was performed in 12 models with a median AUC of 0.80 (95% CI 0.73 to 0.84). One model reported good calibration. Nine models reported external validation with a median AUC of 0.80 (95% CI 0.76 to 0.82). Four models showed good discrimination and calibration on external validation. The pooled AUC of the two validation models of the same developed model was 0.78 (95% CI 0.71 to 0.85). CONCLUSIONS: The performance of the 23 models found in the systematic review varied from fair to good in terms of internal and external validation. Further models should be developed with internal and external validation in low and middle income countries.

High initial concentration versus low initial concentration sevoflurane for inhalational induction of anaesthesia.

BACKGROUND: Sevoflurane induction for general anaesthesia has been reported to be safe, reliable and well accepted by patients. Sevoflurane induction uses either low or high initial concentrations. The low initial concentration technique involves initially administering a low concentration of sevoflurane and gradually increasing the concentration of the dose until the patient is anaesthetized. The high initial concentration technique involves administering high concentrations from the beginning, then continuing with those high doses until the patient is anaesthetized. This review was originally published in 2013 and has been updated in 2016. OBJECTIVES: We aimed to compare induction times and complication rates between high and low initial concentration sevoflurane anaesthetic induction techniques in adults and children who received inhalational induction for general anaesthesia. We defined 'high' as greater than or equal to and 'low' as less than a 4% initial concentration. SEARCH METHODS: For the updated review, we searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2), MEDLINE (1950 to February 2016), EMBASE (1980 to February 2016), Latin American Caribbean Health Sciences Literature (LILACS) (1982 to February 2016) and the Institute for Scientific Information (ISI) Web of Science (1946 to February 2016). We also searched the reference lists of relevant articles and conference proceedings and contacted the authors of included trials. The original search was run in September 2011. SELECTION CRITERIA: We sought all published and unpublished, randomized controlled trials comparing high versus low initial sevoflurane concentration inhalational induction. Our primary outcomes included two measures of anaesthesia (time to loss of the eyelash reflex (LOER) and time until a weighted object held in the patient's hand was dropped), time to successful insertion of a laryngeal mask airway (LMA) and time to endotracheal intubation. Other outcomes were complications of the technique. DATA COLLECTION AND ANALYSIS: We used standardized methods for conducting a systematic review as described in the Cochrane Handbook for Systematic Reviews of Interventions. Two review authors independently extracted details of trial methods and outcome data from reports of all trials considered eligible for inclusion. We conducted all analyses on an intention-to-treat basis, when possible. We estimated overall treatment effects by using a fixed-effect model when we found no substantial heterogeneity, whereas we applied the random-effects model in the presence of considerable heterogeneity. MAIN RESULTS: We reran the searches and included one new study (100 participants) in this updated review. In total, we included 11 studies with 829 participants, although most analyses were based on data from fewer participants and evidence of low quality. We noted substantial heterogeneity in the included trials. Thus, our results should be read with caution. It was not possible to combine trials for the primary outcome (LOER), but individual trials reported faster induction times (typically 24 to 82 seconds faster, 41 seconds (31.37 to 50.62)) with high initial concentration sevoflurane (six studies, 443 participants, low-quality evidence). Apnoea appeared to be more common in the high initial concentration sevoflurane group (risk ratio (RR) 3.14, 95% confidence interval (CI) 1.72 to 5.7, two studies, 160 participants, low-quality evidence). We found no evidence of differences between the two groups in the incidence of cough (odds ratio (OR) 1.23, 95% CI 0.53 to 2.81, eight studies, 589 participants, low-quality evidence), laryngospasm (OR 1.59, 95% CI 0.16 to 15.9, seven studies, 588 participants, low-quality evidence), breath holding (OR 1.16, 95% CI 0.47 to 2.83, five studies, 389 participants, low-quality evidence), patient movement (RR 1.14, 95% CI 0.69 to 1.89, five studies, 445 participants, low-quality evidence) or bradycardia (OR 0.8, 95% CI 0.22 to 2.88, three studies, 199 participants, low-quality evidence), and the overall incidence of complications was low. AUTHORS' CONCLUSIONS: A high initial concentration sevoflurane technique probably offers more rapid induction of anaesthesia and a similar rate of complications, except for apnoea, which may be more common with a high initial concentration. However, this conclusion is not definitive because the included studies provided evidence of low quality.