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BACKGROUND: p value is the most common statistic reported in scientific research articles. Choosing the conventional threshold of 0.05 commonly used for the p value in research articles, is unfounded. Many researchers have tried to provide a reasonable threshold for the p value; some proposed a lower threshold, eg, 0.005. However, none of the proposals has gained universal acceptance. Using the analogy between the diagnostic tests with continuous results and statistical inference tests of hypothesis, I wish to present a method to calculate the most appropriate p value significance threshold using the receiver operating characteristic curve (ROC) analysis. RESULTS: As with diagnostic tests where the most appropriate cut-off values are different depending on the situation, there is no unique cut-off for the p significance threshold. Unlike the previous proposals, which mostly suggest lowering the threshold to a fixed value (eg, from 0.05 to 0.005), the most appropriate p significance threshold proposed here, in most instances, is much less than the conventional cut-off of 0.05 and varies from study to study and from statistical test to test, even within a single study. The proposed method provides the minimum weighted sum of type I and type II errors. CONCLUSIONS: Given the perplexity involved in using the frequentist statistics in a correct way (dealing with different p significance thresholds, even in a single study), it seems that the p value is no longer a proper statistic to be used in our research; it should be replaced by alternative methods, eg, Bayesian methods.
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Curva ROC , Teorema de BayesRESUMO
Electronic patient records (EPRs) are potentially valuable sources of data for service development or research but often contain large amounts of missing data. Using complete case analysis or imputation of missing data seem like simple solutions, and are increasingly easy to perform in software packages, but can easily distort data and give misleading results if used without an understanding of missingness. So, knowing about patterns of missingness, and when to get expert data science (data engineering and analytics) help, will be a fundamental future skill for emergency physicians. This will maximise the good and minimise the harm of the easy availability of large patient datasets created by the introduction of EPRs.
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BACKGROUND AND OBJECTIVE: Various ways exist to display the effectiveness of medical treatment options. This study examined various psychiatric, medical and allied professionals' understanding and perceived usefulness of eight effect size indices for presenting both dichotomous and continuous outcome data. METHODS: We surveyed 1316 participants from 13 countries using an online questionnaire. We presented hypothetical treatment effects of interventions versus placebo concerning chronic pain using eight different effect size measures. For each index, the participants had to judge the magnitude of the shown effect, to indicate how certain they felt about their own answer and how useful they found the given effect size index. FINDINGS: Overall, 762 (57.9%) participants fully completed the questionnaire. In terms of understanding, the best results emerged when both the control event rate (CER) and the experimental event rate (EER) were presented. The difference in minimal importance difference units (MID unit) was understood worst. Respondents also found CER and EER to be the most useful presentation approach while they rated MID unit as the least useful. Confidence in the risk ratio ranked high, even though it was rather poorly understood. CONCLUSIONS AND CLINICAL IMPLICATIONS: For dichotomous outcomes, presenting the effects in terms of the CER and EER could lead to the most correct interpretation. Relative measures including the risk ratio must be supplemented with absolute measures such as the CER and EER. Effects on continuous outcomes were better understood through standardised mean differences than mean differences. These can also be supplemented by dichotomised CER and EER.
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Medicina , Médicos , Humanos , Psiquiatras , Inquéritos e Questionários , OdontólogosRESUMO
BACKGROUND: Approximately 30% of patients experience substantial improvement in depression after 2 months without treatment, and 45% with antidepressants. The smallest worthwhile difference (SWD) refers to an intervention's smallest beneficial effect over a comparison patients deem worthwhile given treatment burdens (harms, expenses and inconveniences), but is undetermined for antidepressants. OBJECTIVE: Estimating the SWD of commonly prescribed antidepressants for depression compared to no treatment. METHODS: The SWD was estimated as a patient-required difference in response rates between antidepressants and no treatment after 2 months. An online cross-sectional survey using Prolific, MQ Mental Health and Amazon Mechanical Turk crowdsourcing services in the UK and USA between October 2022 and January 2023 garnered participants (N=935) that were a mean age of 44.1 (SD=13.9) and 66% women (n=617). FINDINGS: Of 935 participants, 124 reported moderate-to-severe depressive symptoms but were not in treatment, 390 were in treatment and 495 reported absent-to-mild symptoms with or without treatment experiences. The median SWD was a 20% (IQR=10-30%) difference in response rates for people with moderate-to-severe depressive symptoms, not in treatment, and willing to consider antidepressants, and 25% (IQR=10-35%) for the full sample. CONCLUSIONS: Our observed SWDs mean that the current 15% antidepressant benefit over no treatment was sufficient for one in three people to accept antidepressants given the burdens, but two in three expected greater treatment benefits. IMPLICATIONS: While a minority may be satisfied with the best currently available antidepressants, more effective and/or less burdensome medications are needed, with more attention given to patient perspectives.
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Antidepressivos , Crowdsourcing , Humanos , Feminino , Adulto , Masculino , Estudos Transversais , Antidepressivos/uso terapêutico , Saúde Mental , Grupos MinoritáriosRESUMO
AIM: To describe the pattern of the prevalence of mental health problems during the first year of the COVID-19 pandemic and examine the impact of containment measures on these trends. METHODS: We identified articles published until 30 August 2021 that reported the prevalence of mental health problems in the general population at two or more time points. A crowd of 114 reviewers extracted data on prevalence, study and participant characteristics. We collected information on the number of days since the first SARS-CoV-2 infection in the study country, the stringency of containment measures and the number of cases and deaths. We synthesised changes in prevalence during the pandemic using a random-effects model. We used dose-response meta-analysis to evaluate the trajectory of the changes in mental health problems. RESULTS: We included 41 studies for 7 mental health conditions. The average odds of symptoms increased during the pandemic (mean OR ranging from 1.23 to 2.08). Heterogeneity was very large and could not be explained by differences in participants or study characteristics. Average odds of psychological distress, depression and anxiety increased during the first 2 months of the pandemic, with increased stringency of the measures, reported infections and deaths. The confidence in the evidence was low to very low. CONCLUSIONS: We observed an initial increase in the average risk of psychological distress, depression-related and anxiety-related problems during the first 2 months of the pandemic. However, large heterogeneity suggests that different populations had different responses to the challenges imposed by the pandemic.
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COVID-19 , Transtornos Mentais , Humanos , COVID-19/epidemiologia , COVID-19/psicologia , Prevalência , Transtornos Mentais/epidemiologia , SARS-CoV-2 , Pandemias , Ansiedade/epidemiologia , Saúde Mental , Depressão/epidemiologiaRESUMO
QUESTION: For parents of children and young people (CYP) with diagnosed mental health difficulties, what are the levels of parents' well-being and psychological need? STUDY SELECTION AND ANALYSIS: Medline, PsycINFO, EMBASE, AMED, CINAHL, Web of Science and Cochrane Library of Registered Trials were searched from inception to June 2023. INCLUSION CRITERIA: parents of CYP aged 5-18 years with formal mental health diagnosis. Data were extracted from validated measures of well-being or psychological needs with established cut-off points or from a controlled study. FINDINGS: 32 of the 73 310 records screened were included. Pooled means showed clinical range scores for one measure of depression, and all included measures of anxiety, parenting stress and general stress. Meta-analyses showed greater depression (g=0.24, 95% CI 0.11 to 0.38) and parenting stress (g=0.34, 95% CI 0.20 to 0.49) in parents of CYP with mental health difficulties versus those without. Mothers reported greater depression (g=0.42, 95% CI 0.18 to 0.66) and anxiety (g=0.73, 95% CI 0.27 to 1.18) than fathers. Narrative synthesis found no clear patterns in relation to CYP condition. Rates of parents with clinically relevant levels of distress varied. Typically, anxiety, parenting stress and general stress scored above clinical threshold. Quality appraisal revealed few studies with a clearly defined control group, or attempts to control for important variables such as parent gender. CONCLUSIONS: The somewhat mixed results suggest clinical anxiety, parenting and general stress may be common, with sometimes high depression. Assessment and support for parents of CYP with mental health problems is required. Further controlled studies, with consideration of pre-existing parental mental health difficulties are required. PROSPERO REGISTRATION NUMBER: CRD42022344453.
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Cuidadores , Pais , Humanos , Criança , Adolescente , Pais/psicologia , Cuidadores/psicologia , Estresse Psicológico/psicologia , Depressão/psicologia , Depressão/epidemiologia , Transtornos Mentais/psicologia , Transtornos Mentais/epidemiologia , Transtornos Mentais/enfermagem , Ansiedade/psicologia , Pré-Escolar , Poder Familiar/psicologia , Saúde Mental , Masculino , Feminino , Bem-Estar PsicológicoRESUMO
BACKGROUND: Although environmental determinants play an important role in suicide mortality, the quantitative influence of climate change-induced heat anomalies on suicide deaths remains relatively underexamined. OBJECTIVE: The objective is to quantify the impact of climate change-induced heat anomalies on suicide deaths in Australia from 2000 to 2019. METHODS: A time series regression analysis using a generalised additive model was employed to explore the potentially non-linear relationship between temperature anomalies and suicide, incorporating structural variables such as sex, age, season and geographic region. Suicide deaths data were obtained from the Australian National Mortality Database, and gridded climate data of gridded surface temperatures were sourced from the Australian Gridded Climate Dataset. FINDINGS: Heat anomalies in the study period were between 0.02°C and 2.2°C hotter than the historical period due to climate change. Our analysis revealed that approximately 0.5% (264 suicides, 95% CI 257 to 271) of the total 50 733 suicides within the study period were attributable to climate change-induced heat anomalies. Death counts associated with heat anomalies were statistically significant (p value 0.03) among men aged 55+ years old. Seasonality was a significant factor, with increased deaths during spring and summer. The relationship between high heat anomalies and suicide deaths varied across different demographic segments. CONCLUSIONS AND IMPLICATIONS: This study highlights the measurable impact of climate change-induced heat anomalies on suicide deaths in Australia, emphasising the need for increased climate change mitigation and adaptation strategies in public health planning and suicide prevention efforts focusing on older adult men. The findings underscore the importance of considering environmental factors in addition to individual-level factors in understanding and reducing suicide mortality.
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Mudança Climática , Temperatura Alta , Suicídio , Humanos , Austrália/epidemiologia , Masculino , Feminino , Pessoa de Meia-Idade , Suicídio/estatística & dados numéricos , Adulto , Idoso , Temperatura Alta/efeitos adversos , Análise de Regressão , Adulto Jovem , Adolescente , Estações do AnoRESUMO
QUESTION: We examined the effect of study characteristics, risk of bias and publication bias on the efficacy of pharmacotherapy in randomised controlled trials (RCTs) for obsessive-compulsive disorder (OCD). STUDY SELECTION AND ANALYSIS: We conducted a systematic search of double-blinded, placebo-controlled, short-term RCTs with selective serotonergic reuptake inhibitors (SSRIs) or clomipramine. We performed a random-effect meta-analysis using change in the Yale-Brown Obsessive-Compulsive Scale (YBOCS) as the primary outcome. We performed meta-regression for risk of bias, intervention, sponsor status, number of trial arms, use of placebo run-in, dosing, publication year, age, severity, illness duration and gender distribution. Furthermore, we analysed publication bias using a Bayesian selection model. FINDINGS: We screened 3729 articles and included 21 studies, with 4102 participants. Meta-analysis showed an effect size of -0.59 (Hedges' G, 95% CI -0.73 to -0.46), equalling a 4.2-point reduction in the YBOCS compared with placebo. The most recent trial was performed in 2007 and most trials were at risk of bias. We found an indication for publication bias, and subsequent correction for this bias resulted in a depleted effect size. In our meta-regression, we found that high risk of bias was associated with a larger effect size. Clomipramine was more effective than SSRIs, even after correcting for risk of bias. After correction for multiple testing, other selected predictors were non-significant. CONCLUSIONS: Our findings reveal superiority of clomipramine over SSRIs, even after adjusting for risk of bias. Effect sizes may be attenuated when considering publication bias and methodological rigour, emphasising the importance of robust studies to guide clinical utility of OCD pharmacotherapy. PROSPERO REGISTRATION NUMBER: CRD42023394924.
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Clomipramina , Transtorno Obsessivo-Compulsivo , Viés de Publicação , Ensaios Clínicos Controlados Aleatórios como Assunto , Inibidores Seletivos de Recaptação de Serotonina , Transtorno Obsessivo-Compulsivo/tratamento farmacológico , Humanos , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Clomipramina/uso terapêutico , Resultado do Tratamento , Projetos de Pesquisa/normasRESUMO
The number of prediction models for suicide-related outcomes has grown substantially in recent years. These models aim to assist in stratifying risk, improve clinical decision-making, and facilitate a personalised medicine approach to the prevention of suicidal behaviour. However, there are contrasting views as to whether prediction models have potential to inform and improve assessment of suicide risk. In this perspective, we discuss common misconceptions that characterise criticisms of suicide risk prediction research. First, we discuss the limitations of a classification approach to risk assessment (eg, categorising individuals as low-risk vs high-risk), and highlight the benefits of probability estimation. Second, we argue that the preoccupation with classification measures (such as positive predictive value) when assessing a model's predictive performance is inappropriate, and discuss the importance of clinical context in determining the most appropriate risk threshold for a given model. Third, we highlight that adequate discriminative ability for a prediction model depends on the clinical area, and emphasise the importance of calibration, which is almost entirely overlooked in the suicide risk prediction literature. Finally, we point out that conclusions about the clinical utility and health-economic value of suicide prediction models should be based on appropriate measures (such as net benefit and decision-analytic modelling), and highlight the role of impact assessment studies. We conclude that the discussion around using suicide prediction models and risk assessment tools requires more nuance and statistical expertise, and that guidelines and suicide prevention strategies should be informed by the new and higher quality evidence in the field.
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Suicídio , Humanos , Prevenção do Suicídio , Ideação Suicida , Medição de Risco , Valor Preditivo dos TestesRESUMO
BACKGROUND: Blurred work-non-work boundaries can have negative effects on mental health, including sleep. OBJECTIVES: In a randomised control trial, we aimed to assess the effectiveness of an online recovery training programme designed to improve symptoms of insomnia in a working population exposed to blurred boundaries. METHODS: 128 participants with severe insomnia symptoms (Insomnia Severity Index ≥15) and working under blurred work and non-work conditions (segmentation supplies <2.25) were randomly assigned to either the recovery intervention or a waitlist control group (WLC). The primary outcome was insomnia severity, assessed at baseline, after 2 months (T2) and 6 months (T3). FINDINGS: A greater reduction in insomnia was observed in the intervention compared with the WLC group at both T2 (d=1.51; 95% CI=1.12 o 1.91) and T3 (d=1.63; 95% CI=1.23 to 2.03]. This was shown by Bayesian analysis of covariance (ANCOVA), whereby the ANCOVA model yielded the highest Bayes factor (BF 10=3.23×e60] and a 99.99% probability. Likewise, frequentist analysis revealed significantly reduced insomnia at both T2 and T3. Beneficial effects were found for secondary outcomes including depression, work-related rumination, and mental detachment from work. Study attrition was 16% at T2 and 44% at T3. CONCLUSIONS: The recovery training was effective in reducing insomnia symptoms, work related and general indicators of mental health in employees exposed to blurred boundaries, both at T2 and T3. CLINICAL IMPLICATIONS: In addition to demonstrating the intervention's effectiveness, this study exemplifies the utilisation of the Bayesian approach in a clinical context and shows its potential to empower recipients of interventional research by offering insights into result probabilities, enabling them to draw informed conclusions. TRIAL REGISTRATION NUMBER: German Clinical Trial Registration (DRKS): DRKS00006223, https://drks.de/search/de/trial/DRKS00006223.
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Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Humanos , Teorema de Bayes , Distúrbios do Início e da Manutenção do Sono/terapia , Sono , Coleta de DadosRESUMO
OBJECTIVE: Data-driven innovations are essential in strengthening disease control. We developed a low-cost, open-source system for robust epidemiological intelligence in response to the COVID-19 crisis, prioritising scalability, reproducibility and dynamic reporting. METHODS: A five-tiered workflow of data acquisition; processing; databasing, sharing, version control; visualisation; and monitoring was used. COVID-19 data were initially collated from press releases and then transitioned to official sources. RESULTS: Key COVID-19 indicators were tabulated and visualised, deployed using open-source hosting in October 2022. The system demonstrated high performance, handling extensive data volumes, with a 92.5% user conversion rate, evidencing its value and adaptability. CONCLUSION: This cost-effective, scalable solution aids health specialists and authorities in tracking disease burden, particularly in low-resource settings. Such innovations are critical in health crises like COVID-19 and adaptable to diverse health scenarios.
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COVID-19 , Humanos , COVID-19/epidemiologia , Vigilância em Saúde Pública , Reprodutibilidade dos TestesRESUMO
BACKGROUND: Depression and anxiety have increased in prevalence since the start of the COVID-19 pandemic. OBJECTIVE: To evaluate the consumption of antidepressants and anxiolytics from 2012 to 2022 and the pandemic's potential impact in France. METHODS: We conducted an interrupted time series analysis of routine drug sales data (Medic'AM) from all French outpatient pharmacies from 2012 to 2022. We investigated trends in defined daily doses of antidepressants and anxiolytics sold per 1000 inhabitants (DDD/TID) and related expenditures before and after pandemic onset and in relation with stringency of pandemic mitigation measures. Analyses were performed descriptively and using segmented linear regression, autoregressive and autoregressive integrated moving average models. FINDINGS: From 2012 to 2019, overall monthly antidepressant sales increased (+0.02 DDD/TID) while monthly anxiolytic sales decreased (-0.07 DDD/TID). With pandemic onset, there was a relevant and persisting trend increase (+0.20 DDD/TID per month) for antidepressant sales overall, with an estimated excess of 112.6 DDD/TID sold from May 2020 until December 2022. Anxiolytic sales were elevated from February 2020 throughout the pandemic but returned to expected levels by December 2022, with an estimated excess of 33.8 DDD/TID. There was no evident association between stringency and antidepressant or anxiolytic sales. CONCLUSIONS: This study showed a protracted trend increase in the consumption of antidepressants since pandemic onset, while increases in anxiolytic consumption were temporary. CLINICAL IMPLICATIONS: We provide evidence that the COVID-19 pandemic may have had long-lasting consequences on the prevalence and treatment of depression and anxiety disorders, requiring further actions by researchers and policy-makers to address this potential public mental health crisis.
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Ansiolíticos , COVID-19 , Humanos , Ansiolíticos/uso terapêutico , Pandemias , Análise de Séries Temporais Interrompida , Prescrições de Medicamentos , Antidepressivos/uso terapêutico , França/epidemiologiaRESUMO
BACKGROUND: Circadian rhythms influence cognitive performance which peaks in the morning for early chronotypes and evening for late chronotypes. It is unknown whether cognitive interventions are susceptible to such synchrony effects and could be optimised at certain times-of-day. OBJECTIVE: A pilot study testing whether the effectiveness of cognitive bias modification (CBM) for facial emotion processing was improved when delivered at a time-of-day that was synchronised to chronotype. METHODS: 173 healthy young adults (aged 18-25) with an early or late chronotype completed one online session of CBM training in either the morning (06:00 hours to 10:00 hours) or evening (18:00 hours to 22:00 hours). FINDINGS: Moderate evidence that participants learnt better (higher post-training balance point) when they completed CBM training in the synchronous (evening for late chronotypes, morning for early chronotypes) compared with asynchronous (morning for late chronotypes, evening for early chronotypes) condition, controlling for pre-training balance point, sleep quality and negative affect. There was also a group×condition interaction where late chronotypes learnt faster and more effectively in synchronous versus asynchronous conditions. CONCLUSIONS: Preliminary evidence that synchrony effects apply to this psychological intervention. Tailoring the delivery timing of CBM training to chronotype may optimise its effectiveness. This may be particularly important for late chronotypes who were less able to adapt to non-optimal times-of-day, possibly because they experience more social jetlag. CLINICAL IMPLICATIONS: To consider delivery timing of CBM training when administering to early and late chronotypes. This may generalise to other psychological interventions and be relevant for online interventions where the timing can be flexible.
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Cronotipo , Terapia Cognitivo-Comportamental , Emoções , Adolescente , Adulto , Feminino , Humanos , Masculino , Adulto Jovem , Terapia Cognitivo-Comportamental/métodos , Emoções/fisiologia , Expressão Facial , Projetos Piloto , Fatores de TempoRESUMO
BACKGROUND: Individuals with psychiatric disorders have an increased risk of developing dementia. Most cross-sectional studies suffer from selection bias, underdiagnosis and poor population representation, while there is only limited evidence from longitudinal studies on the role of anxiety, bipolar and psychotic disorders. Electronic health records (EHRs) permit large cohorts to be followed across the lifespan and include a wide range of diagnostic information. OBJECTIVE: To assess the association between four groups of psychiatric disorders (schizophrenia, bipolar disorder/mania, depression and anxiety) with dementia in two large population-based samples with EHR. METHODS: Using EHR on nearly 1 million adult individuals in Wales, and from 228 937 UK Biobank participants, we studied the relationships between schizophrenia, mania/bipolar disorder, depression, anxiety and subsequent risk of dementia. FINDINGS: In Secure Anonymised Information Linkage, there was a steep increase in the incidence of a first diagnosis of psychiatric disorder in the years prior to the diagnosis of dementia, reaching a peak in the year prior to dementia diagnosis for all psychiatric diagnoses. Psychiatric disorders, except anxiety, were highly significantly associated with a subsequent diagnosis of dementia: HRs=2.87, 2.80, 1.63 for schizophrenia, mania/bipolar disorder and depression, respectively. A similar pattern was found in the UK Biobank (HRs=4.46, 3.65, 2.39, respectively) and anxiety was also associated with dementia (HR=1.34). Increased risk of dementia was observed for all ages at onset of psychiatric diagnoses when these were divided into 10-year bins. CONCLUSIONS: Psychiatric disorders are associated with an increased risk of subsequent dementia, with a greater risk of more severe disorders. CLINICAL IMPLICATIONS: A late onset of psychiatric disorders should alert clinicians of possible incipient dementia.
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Demência , Transtornos Mentais , Humanos , Demência/epidemiologia , Demência/etiologia , Demência/diagnóstico , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Adulto , Transtornos Mentais/epidemiologia , Transtornos Mentais/diagnóstico , País de Gales/epidemiologia , Registros Eletrônicos de Saúde/estatística & dados numéricos , Transtorno Bipolar/epidemiologia , Transtorno Bipolar/diagnóstico , Reino Unido/epidemiologia , Esquizofrenia/epidemiologia , Esquizofrenia/diagnóstico , Fatores de Risco , Idoso de 80 Anos ou mais , IncidênciaRESUMO
BACKGROUND: Mental health disorders (MHDs) are associated with physical health disparities, but underlying excess risk and health burden have not yet been comprehensively assessed. OBJECTIVE: To assess the burden of comorbid physical health conditions (PHCs) across serious MHDs in Europe. METHODS: We estimated the relative prevalence risk of PHCs associated with alcohol use disorders (AUD), bipolar disorder (BD), depressive disorders (DD) and schizophrenia (SZ) across working-age populations of 32 European countries in 2019 based on a targeted literature review. Excess physical health burden was modelled using population-attributable fractions and country-level prevalence data. FINDINGS: We screened 10 960 studies, of which 41 were deemed eligible, with a total sample size of over 18 million persons. Relative prevalence of PHCs was reported in 54%, 20%, 15%, 5% and 7% of studies, respectively, for SZ, DD, BD, AUD or mixed. Significant relative risk estimates ranged from 1.44 to 3.66 for BD, from 1.43 to 2.21 for DD, from 0.81 to 1.97 for SZ and 3.31 for AUD. Excess physical health burden ranged between 27% and 67% of the total, corresponding to 84 million (AUD), 67 million (BD), 66 million (DD) and 5 million (SZ) PHC diagnoses in Europe. A 1% reduction in excess risk assuming causal inference could result in two million fewer PHCs across investigated MHDs. CONCLUSIONS: This is the first comprehensive study of the physical health burden of serious MHDs in Europe. The methods allow for updates, refinement and extension to other MHDs or geographical areas. CLINICAL IMPLICATIONS: The results indicate potential population health benefits achievable through more integrated mental and physical healthcare and prevention approaches.
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Alcoolismo , Transtorno Bipolar , Esquizofrenia , Humanos , Alcoolismo/complicações , Saúde Mental , Transtorno Bipolar/epidemiologia , Esquizofrenia/epidemiologia , Europa (Continente)/epidemiologiaRESUMO
ABSTRACT OBJECTIVE This study aims to propose a comprehensive alternative to the Bland-Altman plot method, addressing its limitations and providing a statistical framework for evaluating the equivalences of measurement techniques. This involves introducing an innovative three-step approach for assessing accuracy, precision, and agreement between techniques, which enhances objectivity in equivalence assessment. Additionally, the development of an R package that is easy to use enables researchers to efficiently analyze and interpret technique equivalences. METHODS Inferential statistics support for equivalence between measurement techniques was proposed in three nested tests. These were based on structural regressions with the goal to assess the equivalence of structural means (accuracy), the equivalence of structural variances (precision), and concordance with the structural bisector line (agreement in measurements obtained from the same subject), using analytical methods and robust approach by bootstrapping. To promote better understanding, graphical outputs following Bland and Altman's principles were also implemented. RESULTS The performance of this method was shown and confronted by five data sets from previously published articles that used Bland and Altman's method. One case demonstrated strict equivalence, three cases showed partial equivalence, and one showed poor equivalence. The developed R package containing open codes and data are available for free and with installation instructions at Harvard Dataverse at https://doi.org/10.7910/DVN/AGJPZH. CONCLUSION Although easy to communicate, the widely cited and applied Bland and Altman plot method is often misinterpreted, since it lacks suitable inferential statistical support. Common alternatives, such as Pearson's correlation or ordinal least-square linear regression, also fail to locate the weakness of each measurement technique. It may be possible to test whether two techniques have full equivalence by preserving graphical communication, in accordance with Bland and Altman's principles, but also adding robust and suitable inferential statistics. Decomposing equivalence into three features (accuracy, precision, and agreement) helps to locate the sources of the problem when fixing a new technique.
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Intervalos de Confiança , Análise de Regressão , Interpretação Estatística de Dados , Inferência Estatística , Confiabilidade dos DadosRESUMO
Introducción: Es objetivo fundamental de la medicina, determinar las causas que producen las enfermedades; para llevar a cabo este estudio, a finales del siglo XX se emplearon técnicas estadísticas multivariadas confiables en el análisis simultáneo de diferentes variables independientes sobre un desenlace. Objetivo: Determinar la aplicación de la validez racional y de apariencia en la metodología empleada para el estudio de la causalidad en salud. Métodos: Para evaluar si la metodología se correspondía con los requerimientos de la investigación, se aplicó la validez de apariencia para valorar los resultados obtenidos en su aplicación, específicamente, si las reglas reflejan verazmente, lo que ocurre en la práctica médica, mediante el empleo de la validez racional. Resultados: Los usuarios potenciales de la metodología la consideraron aceptable en los aspectos medidos sobre la regresión logística binaria. El mayor porcentaje de las reglas analizadas está en correspondencia con lo planteado en la literatura, pocas plantean aspectos que no se dan necesariamente en la práctica médica, pero tampoco se contradicen con la literatura. Los resultados de la validez de apariencia no fueron favorables, pues la metodología no había sido empleada antes en el contexto. En cuanto a la validez racional, se verificó un alto porcentaje de correspondencia entre lo planteado por las reglas y la literatura. Es importante tener en cuenta, que el hallazgo de algo conocido reafirma la validez de esa regla. Conclusiones: Las reglas obtenidas de la aplicación de la metodología reflejan, en general, lo que ocurre en la práctica médica.
Introduction: the fundamental objective of medicine is to determine the causes that produce diseases. At the end of the 20th century, multivariate statistical techniques were used as reliable in the simultaneous analysis of different independent variables on an outcome. Objective: to determine the application of appearance and rational validity of a methodology to study causality in health. Methods: to evaluate whether the methodology corresponded to the research requirements, appearance validity was applied to assess the results obtained in its application, specifically, if the rules accurately reflect what happens in medical practice, through the use of rational validity. Results: the potential users of the methodology considered it acceptable in the measured aspects of the binary logistic regression. The highest percentage of the rules analyzed is in correspondence with what is stated in the literature; few raise aspects that do not necessarily occur in medical practice, but they do not contradict the literature either. The results of face validity were not favourable, since the methodology had not been used before in the context. A high percentage of correspondence regarding rational validity was verified between what was stated by the rules and the literature. It is important to note that finding something known reaffirms the validity of that rule. Conclusions: the rules obtained from the application of the methodology reflect, in general, what happens in medical practice.
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Interpretação Estatística de Dados , Estudo de Validação , Estudos de Avaliação como AssuntoRESUMO
RESUMO Objetivo: O ensaio TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) visa avaliar se uma intervenção complexa por telemedicina em unidades de terapia intensiva, que se concentra em rondas multidisciplinares diárias realizadas por intensivistas a distância, reduzirá o tempo de permanência na unidade de terapia intensiva em comparação com os cuidados habituais. Métodos: O TELESCOPE é um ensaio nacional, multicêntrico, controlado, aberto, randomizado em cluster. O estudo testa a eficácia de rondas multidisciplinares diárias realizadas por um intensivista por meio de telemedicina em unidades de terapia intensiva brasileiras. O protocolo foi aprovado pelo Comitê de Ética em Pesquisa local do centro coordenador do estudo e pelo Comitê de Ética em Pesquisa local de cada uma das 30 unidades de terapia intensiva, de acordo com a legislação brasileira. O ensaio está registado no ClinicalTrials.gov (NCT03920501). O desfecho primário é o tempo de internação na unidade de terapia intensiva, que será analisado considerando o período basal e a estrutura dos dados em cluster, sendo ajustado por covariáveis predefinidas. Os desfechos exploratórios secundários incluem a classificação de desempenho da unidade de terapia intensiva, a mortalidade hospitalar, a incidência de infecções nosocomiais, o número de dias sem ventilação mecânica aos 28 dias, a taxa de pacientes que recebem alimentação oral ou enteral, a taxa de pacientes sob sedação leve ou em alerta e calmos e a taxa de pacientes sob normoxemia. Conclusão: De acordo com as melhores práticas do ensaio, divulgamos nossa análise estatística antes de bloquear a base de dados e iniciar as análises. Esperamos que essa prática de notificação evite o viés das análises e aprimore a interpretação dos resultados apresentados. Registro no ClinicalTrials.gov:NCT03920501
ABSTRACT Objective: The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care. Methods: The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia. Conclusion: According to the trial's best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results. ClinicalTrials.gov registration:NCT03920501
RESUMO
BACKGROUND: The statistical significance α = 0.05 is the cut-off point used to decide whether a hypothesis is statistically significant. When p-value is less than 0.05, we reject the null hypothesis. Although this criterion has been used for almost a century to generate new knowledge, there is currently an international discussion about the need to decrease the significance to α = 0.005. AIM: To determine the effects that changing the p value would have on the sample size of different types of studies. Material and Methods: A series of formulas for calculating the sample size of cross-sectional and comparative studies were used to create case scenarios. RESULTS: By changing α = 0.05 to α = 0.005, the sample sizes in cross-sectional studies would double and in comparative studies would increase between 60% and 70%, depending on the statistical power chosen. Conclusions: Considering the sample size implications, the change in the level of significance would have important effects on the Chilean science. The cost of a randomized clinical trial could increase by at least 27% to 32%. This increase could be similar for cross-sectional studies. With an investment of less than 0.4% of gross domestic product in science and technology, national scientific research would become more expensive, distributing the few available resources among fewer projects. This effect should be considered in any discussion about national budget for science and technology.