RESUMO
The use of substandard and counterfeit medicines (SCM) leads to significant health and economic consequences, like treatment failure, rise of antimicrobial resistance, extra expenditures of individuals or households and serious adverse drug reactions including death. Our objective was to systematically search, identify and compare relevant available mobile applications (apps) for smartphones and tablets, which use could potentially affect clinical and public health outcomes. We carried out a systematic review of the literature in January 2020, including major medical databases, and app stores. We used the validated Mobile App Rating Scale (MARS) to assess the quality of apps, (1 worst score, 3 acceptable score, and 5 best score). We planned to evaluate the accuracy of the mobile apps to detect SCM. We retrieved 335 references through medical databases and 42 from Apple, Google stores and Google Scholar. We finally included two studies of the medical database, 25 apps (eight from the App Store, eight from Google Play, eight from both stores, and one from Google Scholar), and 16 websites. We only found one report on the accuracy of a mobile apps detecting SCMs. Most apps use the imprint, color or shape for pill identification, and only a few offer pill detection through photographs or bar code. The MARS mean score for the apps was 3.17 (acceptable), with a maximum of 4.9 and a minimum of 1.1. The 'functionality' dimension resulted in the highest mean score (3.4), while the 'engagement' and 'information' dimensions showed the lowest one (3.0). In conclusion, we found a remarkable evidence gap about the accuracy of mobile apps in detecting SCMs. However, mobile apps could potentially be useful to screen for SCM by assessing the physical characteristics of pills, although this should still be assessed in properly designed research studies.
Assuntos
Aplicativos Móveis/normas , Medicamentos Fora do Padrão/análise , Humanos , Saúde Pública , SmartphoneRESUMO
BACKGROUND: The loss of large amounts of blood postpartum can lead to severe maternal morbidity and mortality. Understanding the nature of postpartum blood loss distribution is critical for the development of efficient analysis techniques when comparing treatments to prevent this event. When blood loss is measured, resulting in a continuous volume measure, often this variable is categorized in classes, and reduced to an indicator of volume greater than a cutoff point. This reduction of volume to classes entails a substantial loss of information. As a consequence, very large trials are needed to assess clinically important differences between treatments to prevent postpartum haemorrhage. METHODS: The authors explore the nature of postpartum blood loss distribution, assuming that the physical properties of blood loss lead to a lognormal distribution. Data from four clinical trials and one observational study are used to confirm this empirically. Estimates of probabilities of postpartum haemorrhage events 'blood loss greater than a cutoff point' and relative risks are obtained from the fitted lognormal distributions. Confidence intervals for relative risk are obtained by bootstrap techniques. RESULTS: A variant of the lognormal distribution, the three-parameter lognormal distribution, showed an excellent fit to postpartum blood loss data of the four trials and the observational study. A measurement quality assessment showed that problems of digit preference and lower limit of detection were well handled by the lognormal fit. The analysis of postpartum haemorrhage events based on a lognormal distribution improved the efficiency of the estimates. Sample size calculation for a hypothetical future trial showed that the application of this procedure permits a reduction of sample size for treatment comparison. CONCLUSION: A variant of the lognormal distribution fitted very well postpartum blood loss data from different geographical areas, suggesting that the lognormal distribution might fit postpartum blood loss universally. An approach of analysis of postpartum haemorrhage events based on the lognormal distribution improves efficiency of estimates of probabilities and relative risk, and permits a reduction of sample size for treatment comparison. TRIAL REGISTRATION: This paper reports secondary analyses for trials registered at Australian New Zealand Clinical Trials Registry (ACTRN 12608000434392 and ACTRN12614000870651); and at clinicaltrials.gov (NCT00781066).
Assuntos
Ensaios Clínicos como Assunto , Modelos Teóricos , Hemorragia Pós-Parto/prevenção & controle , Feminino , Humanos , Período Pós-Parto , Gravidez , Índice de Gravidade de DoençaRESUMO
BACKGROUND: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. RESULTS: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. CONCLUSIONS: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. TRIAL REGISTRATION: ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.
Assuntos
Extração Obstétrica/instrumentação , Adulto , Argentina , Colo do Útero/lesões , Extração Obstétrica/efeitos adversos , Extração Obstétrica/métodos , Feminino , Humanos , Períneo/lesões , Projetos Piloto , Gravidez , Resultado da Gravidez , Estudo de Prova de Conceito , África do SulRESUMO
BACKGROUND: Bladder catheterization duration after urinary obstetric fistula surgery varies widely. OBJECTIVE: To assess the effect of bladder catheterization duration after urinary obstetric fistula surgery. SEARCH STRATEGY: Medline, EMBASE, CINAHL, GIM, and POPLINE databases were searched, without language restrictions, using "obstetric urinary fistula" and "catheterization" from inception to September 30, 2017. SELECTION CRITERIA: Randomized controlled trials comparing shorter versus longer (>10 days) bladder catheterization after urinary obstetric fistula repair were included. DATA COLLECTION AND ANALYSIS: Data were extracted and meta-analyses were conducted. The GRADE system was used to assess evidence quality. MAIN RESULTS: Two unblinded non-inferiority trials (684 patients combined) were included. There were no differences between shorter and longer bladder catheterization in the risk of fistula repair breakdown either before (relative risk [RR] 1.14; 95% confidence interval [CI] 0.49-2.64) or after (RR 1.64; 95% CI 0.81-3.31) hospital discharge. Similarly, urinary infection (RR 5.18; 95% CI 0.25-107.44); urinary incontinence before (RR 1.15; 95% CI 0.54-2.43) or after (RR 1.16; 95% CI 0.62-2.18) discharge; urinary retention (RR 1.34; 95% CI 0.79-2.27); or extended hospital stay (RR 9.33; 95% CI 0.51-172.41) were not associated with duration of catheterization. Evidence quality was low or moderate. CONCLUSIONS: Shorter, compared to longer, bladder catheterization duration after urinary obstetric fistula surgery was not associated with significant outcome differences.
Assuntos
Bexiga Urinária/cirurgia , Cateterismo Urinário/métodos , Fístula Urinária/cirurgia , Feminino , Humanos , Gravidez , Fatores de Tempo , Incontinência Urinária/epidemiologia , Infecções Urinárias/epidemiologia , Procedimentos Cirúrgicos Urológicos/métodosRESUMO
OBJECTIVE: To assess the accuracy of angiogenic biomarkers to predict pre-eclampsia. DESIGN: Prospective multicentre study. From 2006 to 2009, 5121 pregnant women with risk factors for pre-eclampsia (nulliparity, diabetes, previous pre-eclampsia, chronic hypertension) from Argentina, Colombia, Peru, India, Italy, Kenya, Switzerland and Thailand had their serum tested for sFlt-1, PlGF and sEng levels and their urine for PlGF levels at ⩽20, 23-27 and 32-35weeks' gestation (index tests, results blinded from carers). Women were monitored for signs of pre-eclampsia, diagnosed by systolic blood pressure ⩾140mmHg and/or diastolic blood pressure ⩾90mmHg, and proteinuria (protein/creatinine ratio ⩾0.3, protein ⩾1g/l, or one dipstick measurement ⩾2+) appearing after 20weeks' gestation. Early pre-eclampsia was defined when these signs appeared ⩽34weeks' gestation. MAIN OUTCOME MEASURE: Pre-eclampsia. RESULTS: Pre-eclampsia was diagnosed in 198 of 5121 women tested (3.9%) of whom 47 (0.9%) developed it early. The median maternal serum concentrations of index tests were significantly altered in women who subsequently developed pre-eclampsia than in those who did not. However, the area under receiver operating characteristics curve at ⩽20weeks' gestation were closer to 0.5 than to 1.0 for all biomarkers both for predicting any pre-eclampsia or at ⩽34weeks' gestation. The corresponding sensitivity, specificity and likelihood ratios were poor. Multivariable models combining sEng with clinical features slightly improved the prediction capability. CONCLUSIONS: Angiogenic biomarkers in first half of pregnancy do not perform well enough in predicting the later development of pre-eclampsia.
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Proteínas Angiogênicas/sangue , Pré-Eclâmpsia/sangue , Pré-Eclâmpsia/diagnóstico , Adulto , Argentina , Biomarcadores/sangue , Biomarcadores/urina , Colômbia , Feminino , Humanos , Índia , Itália , Quênia , Peru , Fator de Crescimento Placentário , Pré-Eclâmpsia/urina , Valor Preditivo dos Testes , Gravidez , Proteínas da Gravidez/sangue , Proteínas da Gravidez/urina , Primeiro Trimestre da Gravidez/sangue , Segundo Trimestre da Gravidez/sangue , Estudos Prospectivos , Sensibilidade e Especificidade , Suíça , Tailândia , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/sangue , Organização Mundial da SaúdeRESUMO
BACKGROUND: The partograph is currently the main tool available to support decision-making of health professionals during labour. However, the rate of appropriate use of the partograph is disappointingly low. Apart from limitations that are associated with partograph use, evidence of positive impact on labour-related health outcomes is lacking. The main goal of this study is to develop a Simplified, Effective, Labour Monitoring-to-Action (SELMA) tool. The primary objectives are: to identify the essential elements of intrapartum monitoring that trigger the decision to use interventions aimed at preventing poor labour outcomes; to develop a simplified, monitoring-to-action algorithm for labour management; and to compare the diagnostic performance of SELMA and partograph algorithms as tools to identify women who are likely to develop poor labour-related outcomes. METHODS/DESIGN: A prospective cohort study will be conducted in eight health facilities in Nigeria and Uganda (four facilities from each country). All women admitted for vaginal birth will comprise the study population (estimated sample size: 7,812 women). Data will be collected on maternal characteristics on admission, labour events and pregnancy outcomes by trained research assistants at the participating health facilities. Prediction models will be developed to identify women at risk of intrapartum-related perinatal death or morbidity (primary outcomes) throughout the course of labour. These predictions models will be used to assemble a decision-support tool that will be able to suggest the best course of action to avert adverse outcomes during the course of labour. To develop this set of prediction models, we will use up-to-date techniques of prognostic research, including identification of important predictors, assigning of relative weights to each predictor, estimation of the predictive performance of the model through calibration and discrimination, and determination of its potential for application using internal validation techniques. DISCUSSION: This research offers an opportunity to revisit the theoretical basis of the partograph. It is envisioned that the final product would help providers overcome the challenging tasks of promptly interpreting complex labour information and deriving appropriate clinical actions, and thus increase efficiency of the care process, enhance providers' competence and ultimately improve labour outcomes. Please see related articles ' http://dx.doi.org/10.1186/s12978-015-0027-6 ' and ' http://dx.doi.org/10.1186/s12978-015-0028-5 '.
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Trabalho de Parto , Complicações do Trabalho de Parto/diagnóstico , Avaliação de Resultados em Cuidados de Saúde , Resultado da Gravidez , Adulto , Feminino , Humanos , GravidezRESUMO
Postpartum haemorrhage (PPH) is an important cause of maternal mortality. We conducted a systematic review of the prevalence of PPH with the objective of evaluating its magnitude both globally and in different regions and settings: global figures, as well as regional, country and provincial variations, are likely to exist but are currently unknown. We used prespecified criteria to select databases, recorded the database characteristics and assessed their methodological quality. After establishing PPH (>or=500 mL blood loss) and severe PPH (SSPH) (>or=1000 mL blood loss) as main outcomes, we found 120 datasets (involving a total of 3,815,034 women) that reported PPH and 70 datasets (505,379 women) that reported SPPH in the primary analysis. The prevalence of PPH and SPPH is approximately 6% and 1.86% of all deliveries, respectively, with a wide variation across regions of the world. The figures we obtained give a rough estimate of the prevalence of PPH and suggest the existence of some variations. For a reliable picture of PPH worldwide - its magnitude, distribution and consequences - a global survey tackling this condition is necessary.
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Placenta Retida/epidemiologia , Hemorragia Pós-Parto/epidemiologia , Complicações Hematológicas na Gravidez/epidemiologia , Feminino , Humanos , Terceira Fase do Trabalho de Parto , Mortalidade Materna , Gravidez , Fatores de RiscoRESUMO
OBJECTIVE: In the past ten years effective treatments for pre-eclampsia and eclampsia have been evaluated and identified following large trials and systematic reviews. We investigated the extent of those effective interventions implementation. METHODS: Descriptive analysis of data collected as part of a cluster randomized trial. The trial was assigned the International Standardised Randomized Controlled Trial Number ISRCTN 14055385. Hospitals with more than 1000 deliveries per year not directly associated with an academic institution in Mexico City municipal area in Mexico (n = 22) and the north-east region of Thailand (n = 18) were included. All women delivering at the participating hospitals at two time periods in 2000 and 2002 contributed data on practice rates. The use of magnesium sulfate for pre-eclampsia and eclampsia were the outcomes. FINDINGS: Eight out of 22 hospitals in Mexico (range 0.8% to 8.5%) and all 18 hospitals in Thailand (range 18.6% to 63.6%) used magnesium sulfate for women with pre-eclampsia. In Mexico, 11 of 22 hospitals used magnesium sulfate for eclampsia (range 9.1% to 60.0%). In Thailand, all 17 hospitals having eclampsia cases used magnesium sulfate (range 25% to 100%). CONCLUSION: Despite compelling evidence, magnesium sulfate use is below desired levels. Clinical practices should be audited and implementation of this effective intervention should be taken up as a priority where universal implementation is not in place.
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Anti-Hipertensivos/uso terapêutico , Eclampsia/tratamento farmacológico , Sulfato de Magnésio/uso terapêutico , Pré-Eclâmpsia/tratamento farmacológico , Uso de Medicamentos , Eclampsia/epidemiologia , Feminino , Humanos , México/epidemiologia , Padrões de Prática Médica , Pré-Eclâmpsia/epidemiologia , Gravidez , Prevalência , Tailândia/epidemiologiaRESUMO
BACKGROUND: Effective strategies for implementing best practices in low and middle income countries are needed. RHL is an annually updated electronic publication containing Cochrane systematic reviews, commentaries and practical recommendations on how to implement evidence-based practices. We are conducting a trial to evaluate the improvement in obstetric practices using an active dissemination strategy to promote uptake of recommendations in The WHO Reproductive Health Library (RHL). METHODS: A cluster randomized trial to improve obstetric practices in 40 hospitals in Mexico and Thailand is conducted. The trial uses a stratified random allocation based on country, size and type of hospitals. The core intervention consists of three interactive workshops delivered over a period of six months. The main outcome measures are changes in clinical practices that are recommended in RHL measured approximately a year after the first workshop. RESULTS: The design and implementation of a complex intervention using a cluster randomized trial design are presented. CONCLUSION: Designing the intervention, choosing outcome variables and implementing the protocol in two diverse settings has been a time-consuming and challenging process. We hope that sharing this experience will help others planning similar projects and improve our ability to implement change.