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Epidemiology
Original research
Prevalence and factors associated with neonatal sepsis in Mali: a cross-sectional study
  1. Fatoumata Bintou Traoré1,2,
  2. Bienvenu Salim Camara3,
  3. Elhadj Marouf Diallo4,
  4. Cheick Sidya Sidibé5,
  5. Alhassane Diallo6,
  6. Sidikiba Sidibé7,
  7. Birama Apho LY8,
  8. Fatimata Yaro9,
  9. Mariam Traoré9,
  10. Haoua Dembelé9,
  11. Abdoulaye Touré10,
  12. Alioune Camara11,
  13. Alexandre Delamou4,
  14. Hamadoun Sangho8
  1. 1 Gamal Abdel Nasser University of Conakry, Conakry, Guinea
  2. 2 Research, National Institute of Public Health, Bamako, Mali
  3. 3 UGANC, Conakry, Guinea
  4. 4 African Centre of Excellence for the Prevention and Control of Communicable Diseases, University of Conakry, Conakry, Guinea
  5. 5 Vrije Universiteit Amsterdam Athena Instituut, Amsterdam, North Holland, The Netherlands
  6. 6 Université Montpellier 1, Montpellier, Occitanie, France
  7. 7 University of Conakry, Department of Public Health, Universite Gamal Abdel Nasser de Conakry, Faculte des Sciences et Techniques de la Sante, Conakry, Guinea
  8. 8 USTTB FMOS, Bamako, Mali
  9. 9 National Institute of Public Health, Bamako, Mali
  10. 10 Center of Research and Training in Infectious Diseases, Gamal Abdel Nasser University of Conakry, Conakry, Guinea
  11. 11 National Malaria Control Programme, Guinea, Conakry, Guinea
  1. Correspondence to Dr Fatoumata Bintou Traoré; tfatoumatab{at}gmail.com

Abstract

Objective This study aimed to assess the prevalence and risk factors for neonatal sepsis among neonates admitted to selected health facilities in the Bamako district and Koulikoro region in Mali.

Design This is a prospective cross-sectional study. Data were analyses using bivariate and multivariate logistic regression.

Setting This facility-based study was conducted in four health facilities consisting of two hospitals and two reference health centres in Mali.

Participants The study participants comprised 795 randomly selected neonates and their indexed mother.

Outcome measures The primary outcome of the study was the prevalence of sepsis in the considered health facilities. The other variables of interest were risk factors for sepsis.

Results The prevalence of neonatal sepsis among the study population was 21.00%. More than 74% of sepsis cases were early onset (<72 hours). Neonatal age <7 days (AOR=2.79, 95% CI 1.59 to 4.89, p=0.000), low birth weight <2500 g (AOR=2.88, 95% CI 1.41 to 5.86, p=0.003), Apgar score <7 (AOR=4.03, 95% CI 3.09 to 5.24, p=0.000), mother with no education (AOR=2.24, 95% CI 1.15 to 4.33, p=0.02), maternal fever (AOR=2.31, 95% CI 1.53 to 3.53, p=0.000), prolonged rupture of membranes (AOR=1.87, 95% CI 1.01 to 3.54, p=0.04) and prolonged labour (AOR=2, 95% CI 1.03 to 3.88, p=0.04) were significantly associated with neonatal sepsis.

Conclusion The prevalence of sepsis in Mali is still high. Given the country’s current security context, the findings in this study can support prevention activities, particularly given the limited resources available. It is essential to facilitate antenatal and postnatal visits, to promote in-facility births and rigorous monitoring of neonates at high risk of sepsis. Furthermore, it would be beneficial for future research on neonatal sepsis to include neonates born at home.

  • EPIDEMIOLOGY
  • NEONATOLOGY
  • PERINATOLOGY
  • Prevalence
  • Risk Factors
  • Paediatric infectious disease & immunisation

Data availability statement

Data are available upon reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2023-082066

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    STRENGTHS AND LIMITATIONS OF THIS STUDY

    • The study was prospective and included health facilities (hospitals and health centres) at different levels of the healthcare system.

    • The study used data from a multitude of health facilities.

    • The majority of sepsis cases were identified based on clinical signs, without laboratory confirmation.

    • The participants were selected from health facilities, and neonates with sepsis who did not attend health facilities could not be included, potentially reducing the generalisability of the results.

    Introduction

    Reducing maternal and newborn mortality and morbidity is an essential element of Goal 3 of the United Nations Sustainable Development Goals. As reported by the WHO, four million neonates die annually within the first 4 weeks of life, with 75% of these deaths occurring within the first week.1 Neonatal sepsis contributes substantially to this morbidity and mortality and is a major global public health challenge.2–5

    Neonatal sepsis is defined as a systemic infection that occurs within the first 28 days after birth. It represents the third-most prevalent direct cause of neonatal death, accounting for approximately 26% of the neonatal deaths globally.6–10 In low and middle income countries, including Mali, it is the leading cause of neonatal mortality and responsible for over half of all neonatal deaths.11–14

    Neonatal sepsis is classified into two subtypes: early and late onset based on the onset time. Early onset sepsis (EOS), when symptoms appear within the first 72 hours after birth, and late onset sepsis (LOS), when symptoms occur after 72 hours after birth.15 EOS is generally caused by micro-organisms acquired before and during delivery (maternal fetal infection), whereas LOS is due to organisms acquired after delivery from the environment (community or nosocomial sources).16 17

    The prevalence of neonatal sepsis varies from country to country. A systematic review in East Africa on neonatal sepsis showed a prevalence of 29.7%.18 In other African countries, the estimated prevalence was 55% in Nigeria,15 49.8% in Tanzania,19 79% in Ethiopia,5 20% in South Africa20 and 21.80% in Uganda.21

    The risk factors for neonatal sepsis in sub-Saharan Africa are low birth weight, resuscitation, low Apgar score at 1 min, prematurity, male sex, prolonged labour, meconium-stained amniotic fluid, preterm rupture of membranes, multiple digital vaginal exams and intrapartum maternal fever.22 The main factors associated with a reduction in morbidity and mortality are prevention, knowledge of risk factors, early recognition of signs and prompt and appropriate management of cases.10 23 24 The knowledge of the risk factors serves as a basis for developing management guidelines and prevention strategies. Although there is a multitude of publications on neonatal sepsis and its factors associated in sub-Saharan African, a key necessity in developing targeted strategies, this cannot be said about Mali. A comprehensive understanding of the common risk factors associated with neonatal sepsis in Mali is crucial for facilitating early diagnosis and treatment of the diseases and could guide public health actions to combat neonatal sepsis.

    In 2017, Mali participated in the Global Maternal Sepsis Study (GLOSS), a research initiative conducted by the WHO in 52 countries worldwide.10 The study’s objective was to develop diagnostic criteria, assess the prevalence of maternal sepsis and evaluate the management of newborns born to suspected or confirmed women with sepsis. However, the study did not identify the risk factors associated with sepsis in Mali, which is necessary for the implementation of effective prevention strategies.

    Besides the lack of data to guide actions to combat neonatal sepsis, Mali is going through a politico-security crisis since 2012, which has further reduced access to healthcare services. Hence, access to and supply of maternal and neonatal health services have been reduced along with a deterioration of care quality,23–27 likely resulting in an increase in diseases among the population, including an increase in sepsis episodes among newborns.

    Also, in a context where part of the national health budget has been redirected to other priority sectors such as security, it would be useful to know what factors are associated with neonatal sepsis.28 The results of this study could guide policymakers in planning preventive measures to reduce sepsis risk in neonates. The aim of this study was therefore to estimate the prevalence of neonatal sepsis in two regions in Mali and identify factors associated with the disease.

    Methods

    Study setting

    The study was carried out in the Gabriel Touré Teaching Hospital (GTTH) (GPS: 12.650874,–7.995945) and the Commune V referral health centre, Bamako (GPS: 12.668744,–7.953923); Kati hospital (GPS: 12.746667,–8.071389) and the Kalabancoro reference health centre, Koulikoro region (GPS: 12.574063011624562,–8.03179311730654). The referral health centres are first-line referral health facilities, Kati hospital is a second-level referral facility and the GTTH; a third-level referral facility.

    Study design and participants

    This cross-sectional study was conducted from December 2022 to January 2023 to assess the prevalence and risks factors associated with neonatal sepsis. The study population comprised neonates and their mothers admitted to selected health facilities’ paediatric and gynaecological wards. Neonates with incomplete patient chart information those who were admitted without their mothers were excluded from the study.

    Sampling techniques

    The health facilities were purposively selected. The GTTH is the largest hospital in Bamako, where the majority of cases of serious maternal and neonatal infections are referred. The Commune V and Kalabancoro Referral Health Centres and the Kati Hospital were included in the previous WHO GLOSS.10

    The sampling frame included all neonates admitted to the different facilities. A systematic random sampling was used for the selection of the neonates and their index mothers. Neonates admitted to paediatrics or neonates born to mothers with sepsis, who were admitted to gynaecology, were systematically included in the study from December 2022 to January 2023 until the sample size was reached. Participants was included in order of their admission in the selected four health facilities’ paediatric and gynaecological ward.

    Sample size calculation

    The sample size for this study was calculated using a single population proportion formula.29 Using the reported proportion of neonatal sepsis of 29.7% in East Africa and a 95% CI, a 3.5% marginal error, a minimum sample size of 722 was estimated of which 10% attrition was added to obtain a final sample size of 795 neonates and their indexed mothers.18

    Study variables

    Outcome variable: neonatal sepsis

    The diagnosis of neonatal sepsis was based on clinical signs and/or biological blood test. A neonate is considered to have sepsis if he/she presented with at least two of the following signs: temperature above 37.5°C, temperature below 35.5°C, convulsions, fast breathing (>60 breaths/min), intense chest tightness, lethargy, swollen nose, grunting, bulging fontanel, pus draining from the ear, umbilical redness extending to the skin, sensation of cold (due to previous history), numerous or severe skin pustules, difficulty to wake up, cannot be soothed in an hour, less normal movements, unable to feed and unable to attach to the breast or suckle.6 21 30

    Predictors variables

    The independent variables included neonates’ sociodemographic and clinical characteristics and maternal sociodemographic, obstetric, socioeconomic and cultural characteristics. Neonate sociodemographic characteristics included gestational age (<37 or ≥37 weeks), age of neonate (<7 or ≥7 days), sex of neonate (male or female), birth weight (<2.5 kg or ≥2.5 kg), Apgar score (<7 or ≥7) and consumption of foods other than breast milk. Maternal sociodemographic, obstetric, socioeconomic and cultural characteristics included maternal age, marital status, maternal education, gestity, parity, history of antenatal care, current pregnancy status, urinary tract infection, intrapartum fever, genital bleeding during pregnancy, duration of labour, prolonged rupture of membranes, per vaginal examination, HIV status, mode of delivery, financial accessibility, father’s financial support, traditional treatment of the newborn’s umbilicus, using of traditional nappies on the newborn and handwashing before handling the newborn.31–33

    Data collection tool and procedure

    Data were collected using a questionnaire (online supplemental file 1) and checklists on the Kobocollect application. The questionnaire was developed based on a review of literature and4 5 33 34 was pretested and subsequent correction made where necessary. For the validation of the tool, a pretest was done on 5% of the total sample size in the Commune VI referral health centre in Bamako among neonates and their mothers; then corrections were made before the start of data collection. The questionnaire has sections on sociodemographic characteristics, maternal factors and neonatal factors. It was developed in French, then translated to the local language (Bambara) and back translated to French to ensure consistency.

    Supplemental material

    Data were collected by four pairs of interviewers, who were doctors or final-year medical students. Two public health doctors supervised the data collection. Prior to the data collection, interviewers and supervisors were trained for 3 days on data-collection approach and tools.

    Data quality assurance and control

    Data quality was monitored at each stage of the study process. First, during the development of the questionnaire in Kobocollect, by predefining response modalities to minimise errors and avoid inconsistencies such as entering outliers.

    Data analysis

    Data were checked for completeness and consistencies, cleaned and then exported to STATA V.17 for analysis (StataCorp, College Station, TX). Descriptive statistics were used to describe and summarise the data. A binary logistic regression analysis was used to determine the association between study variables. Variables with a p value ≤0.25 were entered into the multivariate logistic regression model to identify the risk factors associated with neonatal sepsis.

    Collinearity between the independent variables was checked before adjusting the final model. The Hosmer-Lemeshow test was used to verify the final model’s goodness of fit. To identify factors associated with neonatal sepsis, a crude and adjusted OR with a 95% CI was calculated. Variables with a p value <0.05 in the multivariate analysis were considered statistically significant.

    Patient and public involvement

    The patient and the public were not involved in the design, development, analysis and dissemination of this study.

    Results

    Sociodemographic and clinical characteristics of neonates

    795 neonates with a mean age (±SD) of 3.95±5.82 days with their indexed mothers took part in the study. The majority (n=689/795; 86.67%) were aged <7 days and 424/795 (53.33%) were males. Most of them (n=637/795, 80.13%) had an Apgar score of ≥7 at 5 min. 143 neonates (n=143/795; 17.99%) were born premature and the majority (n=628/795; 78.99%) had a birth weight >2.500 kg (table 1).

    View this table:
    Table 1

    Sociodemographic characteristics of neonates

    The mean (±SD) age of mothers was 26.4±6.5 years with the majority, 351 (44.15%), within the age group of 25–34 years. Most of the mothers, 768 (96.60%), were married and 336 (42.26%) of them had no formal education. Almost all the women attended antenatal care service (ANC) 774 (97.36), with 543 (70.16%) attending more than 3 ANC sessions. 41 (5.16%) of the mothers experienced bleeding throughout pregnancy, with 182 (23%) having a history of urinary tract infections during the pregnancy of the indexed neonate. Most, 546 (68.68%), of the births of the neonates were through spontaneous vaginal delivery. Around 441 (55.47%) of the mothers used shea butter as a cultural practice on the umbilicus of the neonates (table 2).

    View this table:
    Table 2

    Maternal sociodemographic, obstetric, socioeconomic and cultural characteristics

    Prevalence of neonatal sepsis

    Of the 795 neonates who took part in the study, 167 (21.00%) were clinically diagnosed of neonatal sepsis (figure 1). Of these, 74.25% (124/167) presented with EOS with 25.75% presenting with LOS.

    Figure 1
    Figure 1

    Prevalence of neonatal sepsis among the study participants.

    Neonatal and maternal characteristics associated with neonatal sepsis

    Neonatal factors associated with neonatal sepsis

    In bivariate logistic regression analysis to determine variables associated with neonatal sepsis, gestational age <37 weeks, the age of neonate <7 days, birth weights <2.500, Apgar score at 5 min and consumption of foods other than breast milk were candidates for the multivariate logistic regression analyses. However, in the multivariate logistic regression analyses, the following neonatal factors remained significantly associated with neonatal sepsis: age of neonate <7 days, birth weight <2.500 kg Apgar score at 5 min.

    Moreover, neonates aged between 0 and 7 days demonstrated a 2.8-fold increased likelihood of developing neonatal sepsis in comparison to those aged between 8 and 28 days (AOR=2.79, 95% CI 1.59 to 4.89). Similarly, neonates with a birth weight of less than 2.500 kg exhibited a 2.9-fold increased likelihood of developing sepsis in comparison to those with a birth weight of more than 2.500 kg (AOR=2.88, 95% CI 1.41 to 5.86). Similarly, neonates with an APGAR score of less than 7 at 5 min exhibited a 4-fold increased likelihood of developing neonatal sepsis in comparison to neonates with an APGAR score of 7 or above (AOR=4.03, 95% CI 3.09 to 5.24) (table 3).

    View this table:
    Table 3

    Neonatal factors associated with neonatal sepsis in those admitted in the district of Bamako and the region of Koulikoro, 2023 (n=795)

    Maternal characteristics associated with neonatal sepsis

    The bivariate logistic regression analysis revealed that maternal age ≥35 years (OR=1.84, 95% CI 1.12 to 3.03, p=0.01), gestity >3 (OR=1.87, 95% CI 1.30 to 2.68, p=0.001), parity >3 (OR=1.77, 95% CI 1.25 to 2.50, p=0.000), mothers with no formal education (OR=3.41, 95% CI 1.86 to 6.23, p=0.000), multiple pregnancy (OR=1.87, 95% CI 1.1 to 3.21, p=0.02), urinary track infection (UTI) (OR=1.66, 95% CI 1.13 to 2.44, p=0.009), intrapartum fever (OR=2.69; 95% CI 1.86 to 3.88, p=0.000), bleeding during pregnancy (OR=2.28, 95% CI 1.18 to 4.42, p=0.014), hand washing with soap before handling baby (OR=0.46, 95% CI 0.29 to 0.73, p=0.001), prolonged rupture of membranes (OR=4.07, 95% CI 2.51 to 6.60; p=0.000) and prolonged labour (OR=3.98, 95% CI 2.50 to 6.34, p=0.000) were statistically significant predictors of neonatal sepsis.

    The logistic regression was used to adjust for all variables with a p value <0.20. However, when variables were adjusted, as a result, neonates of mothers with no formal education were 2 times likely to develop sepsis compared with neonates whose mothers had a higher level of education (AOR=2.24, 95% CI 1.15 to 4.33). Neonates born to mothers who had a history of fever during labour were 2.31 times more likely to develop sepsis than those born to mothers with no history of fever during pregnancy (AOR=2.31, 95% CI 1.52 to 3.53). Neonates of mothers who had a prolonged rupture of membranes were 2 times more likely to develop sepsis compared with those without prolonged rupture of membranes (AOR=1.87, 95% CI 1.01 to 3.54). Neonates born to mothers who had prolonged labour were 2 times more likely to develop sepsis compared with neonates whose mothers did not have prolonged labour (AOR=2, 95% CI 1.03 to 3.88) (table 4).

    View this table:
    Table 4

    Maternal demographic and clinical characteristics associated with neonatal sepsis in the district of Bamako and the region of Koulikoro, 2023 (n=795)

    Discussion

    This study highlights the considerable risk of neonatal sepsis in Mali, a health problem that is underdocumented in the country. The study revealed that out of 10 newborns, 2 develop sepsis with three-quarters of these neonatal sepsis cases occurring within the first 7 days following birth. Maternal and neonatal factors with neonatal age <7 days, neonate with birth weight <2.500, Apgar score <7, mother’s education level, maternal fever, prolonged rupture of membranes and prolonged labour are significantly associated with neonatal sepsis.

    The prevalence of sepsis in our study (21.00%) was comparable to other studies carried out in different countries: a prevalence of 20.5% in South Africa20 and 26.1% in Ethiopia,35 21.8% in Uganda36 but was higher than those reported in Nigeria with 12.37%,16 Mexico with 4.3%37 and Ghana with 17.3%.34 The possible explanation for this disparity could be due to the differences across study settings, accessibility and setup of countries’ health systems.

    In the current study, among neonates diagnosed with sepsis, 74.25% presented with early-onset neonatal sepsis. Such a burden aligns with those reported in Ethiopia (76.8%),17 Mexico (75.3%)37 and Nigeria (78.2%).15 This high burden of EOS could be due to organisms associated with the female genital tract having urinary infection, if untreated during the third-trimester pregnancy and the colonisation of the birth canal by the infectious agent during labour. The high burden of sepsis among neonates is also probably favoured by inadequate medical monitoring of these neonates over the first days following their birth. Appropriate neonatal medical monitoring would require adequate equipment and availability of care providers; however, in resource-limited countries such as Mali, health facilities still face material and human health resources. Ensuring availability of appropriate equipment and skilled staff to ensure close quality medical monitoring of neonates over the first 7 days following birth (early case management) could contribute to reduce the prevalence of neonatal sepsis.

    Neonates who are aged from 0 to 7 days were 2.8 times more likely to develop neonatal sepsis. Similar findings have been reported by previous studies in north and southwest Ethiopia,17 35 Nigeria15 and Tanzania.19 This could be explained by the fact that the newborn is already in contact with the infectious agent before being born, and then presents these signs directly after delivery. Neonates are very sensitive to different infection agents during the early period due to weakened immunity.

    The birth weight less than 2.500 kg was a risk factors for neonatal sepsis in this study. Our result was consistent with studies conducted in Nagpur, India,38 in Gondar, Ethiopia,30 in Oromia, Ethiopia31 and in Winneba, Ghana.9 Higher risk of sepsis among low birthweight neonates could be linked to the structural and functional immaturity of the neonates’ organs and the weakness of his/her immune system.

    Regarding the Apgar score, our finding is comparable with studies from Ethiopia,39 Tanzania40 and Indonesia.41 Asphyxia causes immunological aggression, and resuscitation procedures after birth asphyxia tends to expose neonates to pathogenic microbes.42

    Intrapartum fever was a predictor of neonatal sepsis in this study. Similar findings were also observed in Ethiopia31 and India.38 Intrapartum fever is an indicator of local or systemic infections such as chorioamniotitis or urinary tract infection. Such infections are often transmitted to the newborn in utero or during passage through the birth canal, and they frequently manifest as EOS.

    The odds of sepsis among neonates from mothers who had attended less than 4 ANC were 2 times higher compared with those whose mothers who had attended 4 or more ANC. This finding is congruent with studies conducted in India38 and Ethiopia.43 Women who benefit from complete ANC may have a better understanding and medical management of the risk factors for sepsis.

    Care provided to mothers during pregnancy and delivery (vaccination, vaginal swabs, intrapartum antibiotic therapy) can make a significant contribution to the prevention of early neonatal sepsis by influencing risk factors such as low birth weight, low Apgar score and maternal fever. It will therefore be important to achieve quality antenatal care in order to prevent early neonatal sepsis.

    This study’s strength lies in its inclusion of hospitals and health centres at various levels of the healthcare system in Mali, as well as its use of data from numerous health facilities. However, potential limitations warrant consideration. Primarily, the majority of sepsis cases were identified based on clinical signs without laboratory confirmation, which may have introduced bias. Additionally, the study participants were selected from health facilities, and neonates with sepsis who did not attend health facilities could not be included, potentially reducing the generalisability of the results.

    Conclusion

    The prevalence of sepsis was high with several maternal and neonatal variables identified as risk factors associated with neonatal sepsis in Mali. A specific emphasis should be placed on enhancing care provided to mothers during the prenatal and perinatal periods, with the objective of reducing the risk of EOS. It will also be crucial to enhance the monitoring and care of newborns who presented with risk factors or were born to mothers with risk factors. For prompt medical intervention, it may be important to improve caregivers’ practices on the neonatal sepsis. This will help to reduce sepsis-related mortality.

    Data availability statement

    Data are available upon reasonable request.

    Ethics statements

    Patient consent for publication

    Ethics approval

    Ethical clearance for the study was obtained from the Ethics Committee of the Faculty of Medicine and Odonto Stomatology, University of Science, Technology and Technology in Bamako (USTTB), (Mali) N: 2022/259/CE/USTTB and from the National Ethics Committee for Health research in Guinea N: 145/CNERS/22. A support letter was obtained from the authorities of the four health facilities where the study was conducted. A free and informed written consent was obtained from each participant prior to any data collection, using a consent form.

    Acknowledgments

    The authors would like to thank the West African Network of African Center of Excellence on Infectious Diseases (WANIDA) and the Development Research Institute (IRD) for their support. We also thank colleagues of Mali National Institute of Public Health for facilitating the fieldwork for this study.

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    Footnotes

    • Contributors FBT, the principal investigator, initiated the study. She designed with BSC and EMD the study protocol. MT, HD, CSS and FY were involved for the acquisition of data and supervised data collection. FBT, BSC, BAL, ALD and SS analysed and interpreted the data. FBT, EMD and CSS drafted the manuscript. AT, AC and ALD contributed to the critical revision of the manuscript. AD and HS supervised the overall study. All authors read and approved the final manuscript. FBT is responsible for the overall content as guarantor.

    • Funding This work is part of a doctoral project, which is partly funded by the West African Network of African Center of Excellence on Infectious Diseases (WANIDA network and the Development Research Institute (IRD); however, those institutions played no role in the study design, data collection, data analysis or writing of the article.

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    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.