Social determinants and exposure to intimate partner violence in women with severe acute maternal morbidity in the intensive care unit: a systematic review.

BACKGROUND: Studying severe acute maternal morbidity in the intensive care unit improves our understanding of potential factors affecting maternal health. AIM: To review evidence on maternal exposure to intimate partner violence and social determinants of health in women with severe acute maternal morbidity in the intensive care unit. METHODS: The protocol for this review was registered in PROSPERO (registration number CRD42016037492). A systematic search was performed in MEDLINE, CINAHL, ProQuest, LILACS and SciELO using the search terms "intensive care unit", "intensive care", "critical care" and "critically ill" in combination with "intimate partner violence", "social determinants of health", "severe acute maternal morbidity", pregnancy, postpartum and other similar terms. Eligible studies were (i) quantitative, (ii) published in English and Spanish, (iii) from 2000 to 2021, (iv) with data related to intimate partner violence and/or social determinants of health, and (v) investigating severe acute maternal morbidity (maternity patients treated in the intensive care unit during pregnancy, childbirth or within 42 days of pregnancy termination). Of 52,866 studies initially identified, 1087 full texts were assessed and 156 studies included. Studies were independently assessed by two reviewers for screening, revision, quality assessment and abstracted data. Studies were categorised into high/middle/low-income countries and summarised data were presented using a narrative description, due to heterogenic data as: (i) exposure to intimate partner violence and (ii) social determinants of health. RESULTS: One study assessed intimate partner violence among mothers with severe acute maternal morbidity in the intensive care unit and found that women exposed to intimate partner violence before and during pregnancy had a nearly four-fold risk of severe acute maternal morbidity requiring ICU admission. Few social determinants of health other than age were reported in most studies. CONCLUSION: This review identified a significant gap in knowledge concerning intimate partner violence and social determinants of health in women with severe acute maternal morbidity in the intensive care unit, which is essential to better understand the complete picture of the maternal morbidity spectrum and reduce maternal mortality.

Evaluation of a rapid serological test for detection of IgM and igG antibodies against SARS-CoV-2 under field conditions. / Evaluación en condiciones de campo de una prueba serológica rápida para detección de anticuerpos IgM e IgG contra SARS-CoV-2.

OBJECTIVE: To determine the additional diagnostic performance of a rapid serological test for detection of IgM and IgG antibodies compared to the real-time polymerase chain reaction (RT-PCR) test; for detection of SARS-CoV-2. MATERIALS AND METHODS: A cross-sectional study was carried out including patients hospitalized for COVID-19 in 3 hospitals, health workers exposed to the infection and outpatients who met suspicious case criteria, all of which underwent the molecular test (RT-PCR) and the rapid serological test. The additional diagnostic performance of rapid serological test was evaluated in comparison to molecular tests. Likewise, an approximation was made to the sensitivity and specificity of the rapid serological test. RESULTS: 144 people were included. With the rapid test, 19.4% of positive results were obtained compared to 11.1% in the molecular test (p = 0.03). The rapid serological test detected 21 cases that had been negative by the initial (RT-PCR), providing an additional diagnostic performance of 56.8% compared to the RT-PCR. The additional diagnostic performance was 50.0% during the first week, 70.0% during the second week and 50.0% during the third week of symptom onset. The sensitivity of the rapid serological test was 43.8% and the specificity of 98.9%. CONCLUSIONS: The rapid serological test was able to detect a greater number of cases than those detected by the molecular test especially after the second week of onset of symptoms. It also showed high specificity. It is therefore useful as a complementary test to RT-PCR, especially during the second and third week of illness.

OBJETIVOS: Determinar el rendimiento diagnóstico adicional de una prueba serológica rápida que detecta anticuerpos IgM e IgG contra SARS-CoV-2 en relación a la reacción en cadena de polimerasa reversa en tiempo real (RT-PCR). MATERIALES Y MÉTODOS: Se realizó un estudio transversal incluyendo pacientes hospitalizados por COVID-19 en tres hospitales, trabajadores de salud expuestos a la infección y pacientes ambulatorios que cumplían criterios de caso sospechoso, a quienes se les realizó la prueba molecular (RT-PCR) y la prueba serológica rápida. Se evaluó el rendimiento diagnóstico adicional de las prueba serológica rápida en relación a la molecular. Asimismo, se realizó la estimación de sensibilidad y especificidad de dichas pruebas. RESULTADOS: Se incluyeron 144 personas. La prueba serológica rápida obtuvo un 19,4% de resultados positivos en comparación con un 11,1% en la prueba molecular (p=0,03). La prueba serológica rápida detectó 21 casos que habían resultado negativos por el RT-PCR inicial y el rendimiento diagnóstico adicional fue de 56,8% en comparación al RT-PCR. El rendimiento diagnóstico adicional fue 50,0% durante la primera semana, 70,0% durante la segunda y 50,0% durante la tercera semana de inicio de síntomas. La sensibilidad de la prueba serológica rápida fue de 43,8% y la especificidad del 98,9%. CONCLUSIONES: La prueba serológica rápida logró detectar un mayor número de casos respecto a la molecular, sobre todo a partir de la segunda semana de inicio de síntomas. Además, presentó una alta especificidad. Los resultados mostrarían su utilidad como prueba complementaria a la prueba molecular, especialmente durante la segunda y tercera semana de enfermedad.

Evaluación en condiciones de campo de una prueba serológica rápida para detección de anticuerpos IgM e IgG contra SARS-CoV-2 / Evaluation of a rapid serological test for detection of IgM and igG antibodies against SARS-CoV-2 under field conditions

RESUMEN Objetivos: Determinar el rendimiento diagnóstico adicional de una prueba serológica rápida que detecta anticuerpos IgM e IgG contra SARS-CoV-2 en relación a la reacción en cadena de polimerasa reversa en tiempo real (RT-PCR). Materiales y métodos: Se realizó un estudio transversal incluyendo pacientes hospitalizados por COVID-19 en tres hospitales, trabajadores de salud expuestos a la infección y pacientes ambulatorios que cumplían criterios de caso sospechoso, a quienes se les realizó la prueba molecular (RT-PCR) y la prueba serológica rápida. Se evaluó el rendimiento diagnóstico adicional de las prueba serológica rápida en relación a la molecular. Asimismo, se realizó la estimación de sensibilidad y especificidad de dichas pruebas. Resultados: Se incluyeron 144 personas. La prueba serológica rápida obtuvo un 19,4% de resultados positivos en comparación con un 11,1% en la prueba molecular (p=0,03). La prueba serológica rápida detectó 21 casos que habían resultado negativos por el RT-PCR inicial y el rendimiento diagnóstico adicional fue de 56,8% en comparación al RT-PCR. El rendimiento diagnóstico adicional fue 50,0% durante la primera semana, 70,0% durante la segunda y 50,0% durante la tercera semana de inicio de síntomas. La sensibilidad de la prueba serológica rápida fue de 43,8% y la especificidad del 98,9%. Conclusiones: La prueba serológica rápida logró detectar un mayor número de casos respecto a la molecular, sobre todo a partir de la segunda semana de inicio de síntomas. Además, presentó una alta especificidad. Los resultados mostrarían su utilidad como prueba complementaria a la prueba molecular, especialmente durante la segunda y tercera semana de enfermedad.

ABSTRACT Objective: To determine the additional diagnostic performance of a rapid serological test for detection of IgM and IgG antibodies compared to the real-time polymerase chain reaction (RT-PCR) test; for detection of SARS-CoV-2. Materials and methods: A cross-sectional study was carried out including patients hospitalized for COVID-19 in 3 hospitals, health workers exposed to the infection and outpatients who met suspicious case criteria, all of which underwent the molecular test (RT-PCR) and the rapid serological test. The additional diagnostic performance of rapid serological test was evaluated in comparison to molecular tests. Likewise, an approximation was made to the sensitivity and specificity of the rapid serological test. Results: 144 people were included. With the rapid test, 19.4% of positive results were obtained compared to 11.1% in the molecular test (p = 0.03). The rapid serological test detected 21 cases that had been negative by the initial (RT-PCR), providing an additional diagnostic performance of 56.8% compared to the RT-PCR. The additional diagnostic performance was 50.0% during the first week, 70.0% during the second week and 50.0% during the third week of symptom onset. The sensitivity of the rapid serological test was 43.8% and the specificity of 98.9%. Conclusions: The rapid serological test was able to detect a greater number of cases than those detected by the molecular test especially after the second week of onset of symptoms. It also showed high specificity. It is therefore useful as a complementary test to RT-PCR, especially during the second and third week of illness.

Burden of injury along the development spectrum: associations between the Socio-demographic Index and disability-adjusted life year estimates from the Global Burden of Disease Study 2017.

BACKGROUND: The epidemiological transition of non-communicable diseases replacing infectious diseases as the main contributors to disease burden has been well documented in global health literature. Less focus, however, has been given to the relationship between sociodemographic changes and injury. The aim of this study was to examine the association between disability-adjusted life years (DALYs) from injury for 195 countries and territories at different levels along the development spectrum between 1990 and 2017 based on the Global Burden of Disease (GBD) 2017 estimates. METHODS: Injury mortality was estimated using the GBD mortality database, corrections for garbage coding and CODEm-the cause of death ensemble modelling tool. Morbidity estimation was based on surveys and inpatient and outpatient data sets for 30 cause-of-injury with 47 nature-of-injury categories each. The Socio-demographic Index (SDI) is a composite indicator that includes lagged income per capita, average educational attainment over age 15 years and total fertility rate. RESULTS: For many causes of injury, age-standardised DALY rates declined with increasing SDI, although road injury, interpersonal violence and self-harm did not follow this pattern. Particularly for self-harm opposing patterns were observed in regions with similar SDI levels. For road injuries, this effect was less pronounced. CONCLUSIONS: The overall global pattern is that of declining injury burden with increasing SDI. However, not all injuries follow this pattern, which suggests multiple underlying mechanisms influencing injury DALYs. There is a need for a detailed understanding of these patterns to help to inform national and global efforts to address injury-related health outcomes across the development spectrum.

Intimate partner violence and severe acute maternal morbidity in the intensive care unit: A case-control study in Peru.

BACKGROUND: Intimate partner violence is a prevalent public health issue associated with all-cause maternal mortality. This study investigated the relationship between intimate partner violence, severe acute maternal morbidity in the intensive care unit (ICU), and neonatal outcomes. METHODS: This was a prospective case-control study in a hospital in Lima, Peru, with 109 cases (maternal ICU admissions) and 109 controls (obstetric patients not admitted to the ICU). Data were collected through face-to-face interviews and medical record review. Partner violence was assessed using the World Health Organization instrument. Multivariate logistic regression was used to model the association between intimate partner violence and severe acute maternal morbidity. RESULTS: There was a significantly higher rate of intimate partner violence both before and during pregnancy among cases (58.7%) than controls (27.5%). In multivariate analysis, intimate partner violence both before and during pregnancy (aOR 3.83 (95% CI: 1.99-7.37)), being married (3.86 (1.27-11.73)), having <8 antenatal care visits (2.78 (1.14-6.80)), and having previous abortions (miscarriage, therapeutic, or unsafe) (1.69 (1.13-2.51)) were significantly associated with severe acute maternal morbidity. The ICU admission rate was 18.8 (per 1000 live births), and ICU maternal mortality was 1.7%. The perinatal mortality rate was higher in cases (9.3%) than in controls (1.8%). CONCLUSIONS: Intimate partner violence was associated with an increased risk of severe acute maternal morbidity. This suggests a more severe impact of intimate partner violence on pregnancy than has been previously identified. Inquiring about intimate partner violence during prenatal visits may prevent further harm to the mother-baby dyad.

Implementation and evaluation of an education programme for nursing staff on recognising, reporting and managing resident-to-resident elder mistreatment in aged care facilities.

AIM: To implement an educational programme for nursing staff on recognising, reporting and managing resident-to-resident elder mistreatment in aged care facilities. BACKGROUND: The phenomenon of a growing ageing population increases the demand of optimum care for older people living in aged care facilities. Caring for older people is complex, but should include the management of aggressive interaction between them. Nursing staff play a vital role in identifying and managing those behaviours. However, many nurses may not recognise these aggressive interactions as abuse. Therefore, this study aims to manage and reduce this abuse through an educational programme. DESIGN: Cluster randomised trial registered on the Australia New Zealand Clinical Trial Registry (ACTRN 12617001618347). METHODS: This trial was undertaken in an aged care facility located in Melbourne, Australia and was funded in January 2017. Wards were randomly allocated (as the intervention and control group) by using sealed opaque envelopes. Nursing staff, who met eligibility, were consecutively recruited and supplied their informed consent. Nurses from the intervention group received an educational programme, while nurses from the control group continued with the usual standard care. Main outcomes included recognising, managing and reporting the abuse before and after the intervention and will be evaluated on an intention-to-treat analysis. DISCUSSION: It is vital to manage and reduce resident-to-resident elder mistreatment. This educational programme may assist nursing staff to protect vulnerable older people experiencing this abuse and may improve comprehensive evidence-based care for older people residing in aged care facilities.

Global Mortality From Firearms, 1990-2016.

Importance: Understanding global variation in firearm mortality rates could guide prevention policies and interventions. Objective: To estimate mortality due to firearm injury deaths from 1990 to 2016 in 195 countries and territories. Design, Setting, and Participants: This study used deidentified aggregated data including 13 812 location-years of vital registration data to generate estimates of levels and rates of death by age-sex-year-location. The proportion of suicides in which a firearm was the lethal means was combined with an estimate of per capita gun ownership in a revised proxy measure used to evaluate the relationship between availability or access to firearms and firearm injury deaths. Exposures: Firearm ownership and access. Main Outcomes and Measures: Cause-specific deaths by age, sex, location, and year. Results: Worldwide, it was estimated that 251 000 (95% uncertainty interval [UI], 195 000-276 000) people died from firearm injuries in 2016, with 6 countries (Brazil, United States, Mexico, Colombia, Venezuela, and Guatemala) accounting for 50.5% (95% UI, 42.2%-54.8%) of those deaths. In 1990, there were an estimated 209 000 (95% UI, 172 000 to 235 000) deaths from firearm injuries. Globally, the majority of firearm injury deaths in 2016 were homicides (64.0% [95% UI, 54.2%-68.0%]; absolute value, 161 000 deaths [95% UI, 107 000-182 000]); additionally, 27% were firearm suicide deaths (67 500 [95% UI, 55 400-84 100]) and 9% were unintentional firearm deaths (23 000 [95% UI, 18 200-24 800]). From 1990 to 2016, there was no significant decrease in the estimated global age-standardized firearm homicide rate (-0.2% [95% UI, -0.8% to 0.2%]). Firearm suicide rates decreased globally at an annualized rate of 1.6% (95% UI, 1.1-2.0), but in 124 of 195 countries and territories included in this study, these levels were either constant or significant increases were estimated. There was an annualized decrease of 0.9% (95% UI, 0.5%-1.3%) in the global rate of age-standardized firearm deaths from 1990 to 2016. Aggregate firearm injury deaths in 2016 were highest among persons aged 20 to 24 years (for men, an estimated 34 700 deaths [95% UI, 24 900-39 700] and for women, an estimated 3580 deaths [95% UI, 2810-4210]). Estimates of the number of firearms by country were associated with higher rates of firearm suicide (P < .001; R2 = 0.21) and homicide (P < .001; R2 = 0.35). Conclusions and Relevance: This study estimated between 195 000 and 276 000 firearm injury deaths globally in 2016, the majority of which were firearm homicides. Despite an overall decrease in rates of firearm injury death since 1990, there was variation among countries and across demographic subgroups.

A systematic review protocol of educational programs for nursing staff on management of resident-to-resident elder mistreatment in residential aged care homes.

AIM: To review evidence concerning educational programs for nursing staff on management of resident-to-resident elder mistreatment with the aim of preventing and reducing this abuse in residential aged care homes. BACKGROUND: Although elder abuse has received considerable attention, very little is known regarding resident-to-resident elder mistreatment in residential aged care homes and about interventions/programs to prevent and reduce this harm. Nurses play an essential role in identifying and managing aggressive interactions. However, many nurses may not recognize these behaviours as forms of abuse. Thus, it is important to ascertain if educational programs for nursing staff have been developed and implemented. DESIGN: Quantitative systematic review registered on PROSPERO (CRD42017080925). METHODS: A systematic search of English published studies between 1980 - 2017 will be conducted in CINAHL, Embase, MEDLINE, ProQuest, PsychInfo and Scopus. Risk of bias and quality of the studies will be evaluated by using the Cochrane Collaboration's tool and the Methodological Index for Nonrandomized studies. A meta-analysis will be performed, if sufficient homogeneity exists; otherwise, data will be summarized by using a narrative description. This study was funded in January 2017. DISCUSSION: Nursing staff should play a pivotal role in preventing and/or reducing resident-to-resident elder mistreatment. Therefore, it is important to identify available educational programs for nursing staff dealing with this abuse. Consequently, this review may provide evidence-based care for nursing staff to assist them in protecting older residents from experiencing abuse or being abused and in improving their well-being.

Impact of violence against women on severe acute maternal morbidity in the intensive care unit, including neonatal outcomes: a case-control study protocol in a tertiary healthcare facility in Lima, Peru.

INTRODUCTION: Preventing and reducing violence against women (VAW) and maternal mortality are Sustainable Development Goals. Worldwide, the maternal mortality ratio has fallen about 44% in the last 25 years, and for one maternal death there are many women affected by severe acute maternal morbidity (SAMM) requiring management in the intensive care unit (ICU). These women represent the most critically ill obstetric patients of the maternal morbidity spectrum and should be studied to complement the review of maternal mortality. VAW has been associated with all-cause maternal deaths, and since many women (30%) endure violence usually exerted by their intimate partners and this abuse can be severe during pregnancy, it is important to determine whether it impacts SAMM. Thus, this study aims to investigate the impact of VAW on SAMM in the ICU. METHODS AND ANALYSIS: This will be a prospective case-control study undertaken in a tertiary healthcare facility in Lima-Peru, with a sample size of 109 cases (obstetric patients admitted to the ICU) and 109 controls (obstetric patients not admitted to the ICU selected by systematic random sampling). Data on social determinants, medical and obstetric characteristics, VAW, pregnancy and neonatal outcome will be collected through interviews and by extracting information from the medical records using a pretested form. Main outcome will be VAW rate and neonatal mortality rate between cases and controls. VAW will be assessed by using the WHO instrument. Binary logistic followed by stepwise multivariate regression and goodness of fit test will assess any association between VAW and SAMM. ETHICS AND DISSEMINATION: Ethical approval has been granted by the La Trobe University, Melbourne-Australia and the tertiary healthcare facility in Lima-Peru. This research follows the WHO ethical and safety recommendations for research on VAW. Findings will be presented at conferences and published in peer-reviewed journals.

Voices from low-income and middle-income countries: a systematic review protocol of primary healthcare interventions within public health systems addressing intimate partner violence against women.

INTRODUCTION: Intimate partner violence (IPV) considerably harms the health, safety and well-being of women. In response, public health systems around the globe have been gradually implementing strategies. In particular, low-income and middle-income countries (LMIC) have been developing innovative interventions in primary healthcare (PHC) addressing the problem. This paper describes a protocol for a systematic review of studies addressing the impacts and outcomes of PHC centre interventions addressing IPV against women from LMIC. METHODS AND ANALYSIS: A systematic search for studies will be conducted in African Index Medicus, Africa Portal Digital Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Index Medicus for the Southeast Asia Region, IndMed, Latin American and Caribbean Health Science Literature Database (LILACS), Medecins Sans Frontieres, MEDLINE, Minority Health and Health Equity Archive, ProQuest, PsycINFO, Scientific Electronic Library Online, (SciELO) and Social Policy and Practice. Studies will be in English, Spanish and Portuguese, published between 2007 and 2017, addressing IPV against women from LMIC, whose data quantitatively report on the impacts and outcomes for survivors and/or workers and/or public health systems preintervention and postintervention. Two trilingual reviewers will independently screen for study eligibility and data extraction, and a librarian will cross-check for compliance. Risk of bias and quality assessment of studies will be measured according to: (1) the Cochrane Collaboration's tool for assessing risk of bias for randomised controlled trials and (2) the Methodological Index for Non-Randomised Studies (MINORS). Data will be analysed and summarised using meta-analysis and narrative description of the evidence across studies. This systematic review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols(PRISMA P) guidelines. ETHICS AND DISSEMINATION: This systematic review will be based on published studies, thus not requiring ethical approval. Findings will be presented in conferences and published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42017069261.

Child and Adolescent Health From 1990 to 2015: Findings From the Global Burden of Diseases, Injuries, and Risk Factors 2015 Study.

Importance: Comprehensive and timely monitoring of disease burden in all age groups, including children and adolescents, is essential for improving population health. Objective: To quantify and describe levels and trends of mortality and nonfatal health outcomes among children and adolescents from 1990 to 2015 to provide a framework for policy discussion. Evidence Review: Cause-specific mortality and nonfatal health outcomes were analyzed for 195 countries and territories by age group, sex, and year from 1990 to 2015 using standardized approaches for data processing and statistical modeling, with subsequent analysis of the findings to describe levels and trends across geography and time among children and adolescents 19 years or younger. A composite indicator of income, education, and fertility was developed (Socio-demographic Index [SDI]) for each geographic unit and year, which evaluates the historical association between SDI and health loss. Findings: Global child and adolescent mortality decreased from 14.18 million (95% uncertainty interval [UI], 14.09 million to 14.28 million) deaths in 1990 to 7.26 million (95% UI, 7.14 million to 7.39 million) deaths in 2015, but progress has been unevenly distributed. Countries with a lower SDI had a larger proportion of mortality burden (75%) in 2015 than was the case in 1990 (61%). Most deaths in 2015 occurred in South Asia and sub-Saharan Africa. Global trends were driven by reductions in mortality owing to infectious, nutritional, and neonatal disorders, which in the aggregate led to a relative increase in the importance of noncommunicable diseases and injuries in explaining global disease burden. The absolute burden of disability in children and adolescents increased 4.3% (95% UI, 3.1%-5.6%) from 1990 to 2015, with much of the increase owing to population growth and improved survival for children and adolescents to older ages. Other than infectious conditions, many top causes of disability are associated with long-term sequelae of conditions present at birth (eg, neonatal disorders, congenital birth defects, and hemoglobinopathies) and complications of a variety of infections and nutritional deficiencies. Anemia, developmental intellectual disability, hearing loss, epilepsy, and vision loss are important contributors to childhood disability that can arise from multiple causes. Maternal and reproductive health remains a key cause of disease burden in adolescent females, especially in lower-SDI countries. In low-SDI countries, mortality is the primary driver of health loss for children and adolescents, whereas disability predominates in higher-SDI locations; the specific pattern of epidemiological transition varies across diseases and injuries. Conclusions and Relevance: Consistent international attention and investment have led to sustained improvements in causes of health loss among children and adolescents in many countries, although progress has been uneven. The persistence of infectious diseases in some countries, coupled with ongoing epidemiologic transition to injuries and noncommunicable diseases, require all countries to carefully evaluate and implement appropriate strategies to maximize the health of their children and adolescents and for the international community to carefully consider which elements of child and adolescent health should be monitored.

Social determinants and maternal exposure to intimate partner violence of obstetric patients with severe maternal morbidity in the intensive care unit: a systematic review protocol.

INTRODUCTION: Maternal mortality is a potentially preventable public health issue. Maternal morbidity is increasingly of interest to aid the reduction of maternal mortality. Obstetric patients admitted to the intensive care unit (ICU) are an important part of the global burden of maternal morbidity. Social determinants influence health outcomes of pregnant women. Additionally, intimate partner violence has a great negative impact on women's health and pregnancy outcome. However, little is known about the contextual and social aspects of obstetric patients treated in the ICU. This study aimed to conduct a systematic review of the social determinants and exposure to intimate partner violence of obstetric patients admitted to an ICU. METHODS AND ANALYSIS: A systematic search will be conducted in MEDLINE, CINAHL, ProQuest, LILACS and SciELO from 2000 to 2016. Studies published in English and Spanish will be identified in relation to data reporting on social determinants of health and/or exposure to intimate partner violence of obstetric women, treated in the ICU during pregnancy, childbirth or within 42 days of the end of pregnancy. Two reviewers will independently screen for study eligibility and data extraction. Risk of bias and assessment of the quality of the included studies will be performed by using the Critical Appraisal Skills Programme (CASP) checklist. Data will be analysed and summarised using a narrative description of the available evidence across studies. This systematic review protocol will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines. ETHICS AND DISSEMINATION: Since this systematic review will be based on published studies, ethical approval is not required. Findings will be presented at La Trobe University, in Conferences and Congresses, and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: CRD42016037492.

Manual de procedimientos para la realización de ensayos clínicos en el Perú / Manual of procedures for conducting clinical testing in Peru

En la publicación identifican nuevas disposiciones legales y procedimientos técnico administrativos en el marco de los requisitos y dispositivos del Reglamento de ensayos clínicos en el Perú y normatividad conexa, primando el respeto a los postulados y principios éticos enmarcados en la justicia y equidad como principal función del Estado; además de utilizar estándares de calidad técnica y legal

Manual de procedimientos para la realización de ensayos clínicos en el Perú / Manual of procedures for conducting clinical testing in Peru

En la presente publicación identifican nuevas disposiciones legales y procedimientos técnico administrativos en el marco de los requisitos y dispositivos del Reglamento de ensayos clínicos en el Perú y normatividad conexa, primando el respeto a los postulados y principios éticos enmarcados en la justicia y equidad como principal función del Estado; además de utilizar estándares de calidad técnica y legal(AU)

Características de los ensayos clínicos autorizados en el Perú, 1995-2012 / Characteristics of clinical trials authorized in Peru: 1995-2012

Objetivos. Describir las principales características de los ensayos clínicos (EC) autorizados en el Perú desde 1995 a agosto de 2012. Materiales y métodos. Se realizó un estudio transversal, en el que se revisaron todos los expedientes de protocolos de EC presentados para su evaluación y posible aprobación al INS, cuyos datos forman parte del Registro Peruano de EC. Se realizó el análisis descriptivo de los estados de aprobación de los EC, fase de estudio, especialidad, y otras características afines a ellos. Resultados. Se encontraron 1475 EC, de los cuales 1255 (85,1%) fueron autorizados. De un EC registrado el año 1995 se incrementó a 176 ensayos presentados en el 2008, disminuyendo en el 2011 a 128 ensayos. Entre los EC aprobados, el 64,1% corresponden a EC en fase III. Oncología (22,4%), Infectología (15,5%) y Endocrinología (12,7%) fueron las especialidades más estudiadas y solo el 1.19%, corresponde a enfermedades tropicales desatendidas. Los hipoglicemiantes orales, antivirales de uso sistémico y antineoplásico fueron los medicamentos más estudiados. La industria farmacéutica transnacional fue el principal patrocinador (87,1%) y ejecutor de ensayos clínicos (62,3%) los cuales se realizan mayormente en Lima. Conclusiones. Los ensayos clínicos que se realizan en el país son principalmente en enfermedades no transmisibles y son estudios en fase III. La industria farmacéutica constituye el principal patrocinador. Solo el 1.2%, corresponde a enfermedades tropicales desatendidas, lo cual muestra la poca atención a los problemas de salud de poblaciones en situaciones de vulnerabilidad.

Objective. To identify main characteristics of clinical trials (CT) authorized by the National Institute of Health (INS) of Peru from 1995 to August 2012. Material and methods. Cross-sectional study, which reviewed all records of CT submitted for review and possible approval by INS, whose data are part of the Peruvian Registry of Clinical Trials. We performed a descriptive analysis of the states of the CT approval and other characteristics. Results. 1475 clinical trials were assessed, of which 1255 (85.1%) were authorized. From 1 clinical trial officially registered in 1995, its quantity increased to 176 trials submitted in 2008, and then, declined to 128 in 2011. Among the approved CT, 64.1% was in Phase III. Oncology (22.4%), infectious diseases (15.5%) and endocrinology (12.7%) were the most studied specialties and a only 1.2% were for neglected tropical diseases. The oral hypoglycemic drugs, systemic antiviral and antineoplastic agents were the most studied investigational products. The transnational pharmaceutical industry was the main sponsor (87.1%) and executors (62.3%) of clinical trials were mostly in Lima. Conclusions. Clinical trials in Peru mainly focus on noncommunicable diseases and phase III studies. The pharmaceutical industry is the main sponsor. A very small number of authorized clinical trials in Peru were for neglected tropical diseases that shows little attention to the health problems in vulnerable populations.