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1.
Eur Psychiatry ; 67(1): e19, 2024 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-38389390

RESUMO

BACKGROUND: A short yet reliable cognitive measure is needed that separates treatment and placebo for treatment trials for Alzheimer's disease. Hence, we aimed to shorten the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) and test its use as an efficacy measure. METHODS: Secondary data analysis of participant-level data from five pivotal clinical trials of donepezil compared with placebo for Alzheimer's disease (N = 2,198). Across all five trials, cognition was appraised using the original 11-item ADAS-Cog. Statistical analysis consisted of sample characterization, item response theory (IRT) to identify an ADAS-Cog short version, and mixed models for repeated-measures analysis to examine the effect sizes of ADAS-Cog change on the original and short versions in the placebo versus donepezil groups. RESULTS: Based on IRT, a short ADAS-Cog was developed with seven items and two response options. The original and short ADAS-Cog correlated at baseline and at weeks 12 and 24 at 0.7. Effect sizes based on mixed modeling showed that the short and original ADAS-Cog separated placebo and donepezil comparably (ADAS-Cog original ES = 0.33, 95% CI = 0.29, 0.40, ADAS-Cog short ES = 0.25, 95% CI =0.23, 0.34). CONCLUSIONS: IRT identified a short ADAS-cog version that separated donepezil and placebo, suggesting its clinical potential for assessment and treatment monitoring.


Assuntos
Doença de Alzheimer , Transtornos Cognitivos , Humanos , Doença de Alzheimer/diagnóstico , Doença de Alzheimer/tratamento farmacológico , Doença de Alzheimer/psicologia , Donepezila/uso terapêutico , Cognição
2.
JAMA Netw Open ; 6(10): e2338088, 2023 10 02.
Artigo em Inglês | MEDLINE | ID: mdl-37847497

RESUMO

Importance: Evidence that adult attention-deficit/hyperactivity disorder (ADHD) is associated with an increased risk of dementia is scarce and inconsistent, and potential sources of bias are untested. Objective: To examine the association between adult ADHD and the risk of dementia. Design, Setting, and Participants: This prospective national cohort study consisted of 109 218 members of a nonprofit Israeli health maintenance organization born between 1933 and 1952 who entered the cohort on January 1, 2003, without an ADHD or dementia diagnosis and were followed up to February 28, 2020. Participants were aged 51 to 70 years in 2003. Statistical analysis was conducted from December 2022 to August 2023. Exposure: Adult ADHD was a time-varying covariate, classified as present from the age of the first diagnosis (using the International Classification of Diseases, Ninth Revision, and the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision); otherwise, absent. Main Outcome and Measures: Cox regression models were fitted to quantify the association between adult ADHD and the risk of incident dementia with hazard ratios (HRs) and their 95% CIs unadjusted and in the primary analysis, using inverse probability weights, adjusted for 18 sources of potential confounding. In 14 complementary analyses, subgroup and sensitivity analyses were implemented. Results: At the beginning of the follow-up, the sample of 109 218 participants had a mean (SD) age of 57.7 (5.5) years, 56 474 participants (51.7%) were female, and 52 744 (48.3%) were male. During follow-up, 730 participants (0.7%) received a diagnosis of adult ADHD, and 7726 (7.1%) received a diagnosis of dementia. Dementia occurred among 96 of 730 participants (13.2%) with adult ADHD and 7630 of 108 488 participants (7.0%) without adult ADHD. In the primary analysis, compared with the absence of adult ADHD, the presence of adult ADHD was statistically significantly (P < .001) associated with an increased dementia risk (unadjusted HR, 3.62 [95% CI, 2.92-4.49; P < .001]; adjusted HR, 2.77 [95% CI, 2.11-3.63; P < .001]). Twelve of the 14 complementary analyses did not attenuate the conclusions based on the results of the primary analysis. There was, however, no clear increase in the risk of dementia associated with adult ADHD among those who received psychostimulant medication, and evidence of reverse causation was mild. Conclusions and Relevance: In this cohort study of individuals born between 1933 and 1952 and followed up in old age, adult ADHD was associated with an increased risk of dementia. Policy makers, caregivers, patients, and clinicians may wish to monitor reliably for ADHD in old age.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade , Estimulantes do Sistema Nervoso Central , Demência , Humanos , Masculino , Adulto , Feminino , Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Estudos de Coortes , Estudos Prospectivos , Estimulantes do Sistema Nervoso Central/uso terapêutico , Demência/etiologia , Demência/complicações
3.
Schizophr Res ; 261: 24-30, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37688910

RESUMO

Examining the heterogeneity of negative symptoms of schizophrenia contributes to the identification of available treatment targets. Generally, prior evidence classified three to four symptom treatment response trajectory groups over the course of positive symptoms, yet, no evidence exists regarding the heterogeneity of medium-term response to predominant negative symptoms. The current post-hoc analysis aims to identify the heterogeneity in negative symptom treatment response trajectories among patients with predominant negative symptoms who received either cariprazine or risperidone for 26 weeks. Treatment response was analyzed based on the: the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS), and the Clinical Global Impression Severity (CGIS) and Improvement (CGII) scales. To identify subgroups of patients with a similar course of treatment response, group-based trajectory modelling was utilized. Results demonstrated that in comparison with competing models, a single trajectory best described the treatment response of patients with predominant negative symptoms. The results indicate that patients with predominant negative symptoms with over ten years of schizophrenia respond rapidly to adequate treatment and follow a course of steady improvement.


Assuntos
Antipsicóticos , Risperidona , Humanos , Antipsicóticos/uso terapêutico , Método Duplo-Cego , Piperazinas/uso terapêutico , Escalas de Graduação Psiquiátrica , Risperidona/uso terapêutico , Resultado do Tratamento
4.
Public Health Nutr ; 26(8): 1715-1727, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37165566

RESUMO

OBJECTIVE: To support school foods programmes by evaluating the relationship between nutritional quality, cost, student consumption and the environmental impacts of menus. DESIGN: Using linear programming and data from previously served menu items, the relationships between the nutritional quality, cost, student consumption and the environmental impacts of lunch menus were investigated. Optimised lunch menus with the maximum potential student consumption and nutritional quality and lowest costs and environmental impacts were developed and compared with previously served menus (baseline). SETTING: Boston Public Schools (BPS), Boston Massachusetts, USA. PARTICIPANTS: Menu items served on the 2018-2019 BPS lunch menu (n 142). RESULTS: Using single-objective models, trade-offs were observed between most interests, but the use of multi-objective models minimised these trade-offs. Compared with the current weekly menus offered, multi-objective models increased potential caloric intake by up to 27 % and Healthy Eating Index scores by up to 19 % and reduced costs and environmental impacts by up to 13 % and 71 %, respectively. Improvements were made by reducing the frequency of beef and cheese entrées and increasing the frequency of fish and legume entrées on weekly menus. CONCLUSIONS: This work can be extrapolated to monthly menus to provide further direction for school districts, and the methods can be employed with different recipes and constraints. Future research should test the implementation of optimised menus in schools and consider the broader implications of implementation.


Assuntos
Serviços de Alimentação , Almoço , Animais , Bovinos , Planejamento de Cardápio , Instituições Acadêmicas , Meio Ambiente
5.
Psychol Med ; 53(15): 7350-7357, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37114455

RESUMO

BACKGROUND: Lower cognitive functioning has been documented across psychiatric disorders and hypothesized to be a core deficit of mental disorders. Situating psychopathology and cognition as part of a unitary construct is therefore important to understanding the etiology of psychiatric disorders. The current study aims to test competing structural models of psychopathology and cognition in a large national cohort of adolescents. METHODS: The analytic sample consisted of 1189 participants aged 16-17 years, screened by the Israeli Draft Board. Psychopathology was assessed using a modified version of the Brief Symptom Inventory, and cognition was assessed based on four standardized test scores ((1) mathematical reasoning, concentration, and concept manipulation; (2) visual-spatial problem-solving skills and nonverbal abstract reasoning; (3) verbal understanding; (4) categorization and verbal abstraction). Confirmatory factor analysis was implemented to compare competing structural models of psychopathology with and without cognition. Sensitivity analyses examined the models in different subpopulations. RESULTS: Confirmatory factor analysis indicated a better model fit of psychopathological symptoms without cognition (RMSEA = 0.037; TLI = 0.991; CFI = 0.992) than with cognition (RMSEA = 0.04-0.042; TLI = 0.987-0.988; CFI = 0.988-0.989). Sensitivity analyses supported the robustness of these results with a single exception. Among participants with low cognitive abilities (N = 139), models that integrated psychopathological symptoms with cognition had a better fit compared to models of psychopathology without cognition. CONCLUSIONS: The current study suggests that cognition and psychopathology are, generally, independent constructs. However, within low cognitive abilities, cognition was integral to the structure of psychopathology. Our results point toward an increased vulnerability to psychopathology in individuals with low cognitive abilities and may provide valuable information for clinicians.


Assuntos
Transtornos Mentais , Psicopatologia , Adolescente , Humanos , Estudos de Coortes , Transtornos Mentais/psicologia , Cognição , Compreensão
6.
Psychol Med ; 53(15): 7300-7308, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37092864

RESUMO

BACKGROUND: Maternal Rheumatoid Arthritis (RA) is suggested to increase the risk of Autism Spectrum Disorder (ASD) in the offspring, mainly through inflammation/autoimmunity, but the association is unclear. A prospective population-based cohort study was implemented to examine the association between maternal RA and offspring ASD. METHODS: We included all children born alive in Sweden from 1995 to 2015, followed up through 2017. Diagnoses of ASD and RA were clinically ascertained from National Patient Register. We quantified the association by hazard ratios (HR) and two-sided 95% confidence intervals (CI), from Cox regression after detailed adjustment for potential confounders. We examined RA serostatus, etiological subgroups and the timing of exposure. To closer examine the underlying mechanism for the association, we included a negative control group for RA, arthralgia, with similar symptomology as RA but free from inflammation/autoimmunity. RESULTS: Of 3629 children born to mothers with RA, 70 (1.94%) were diagnosed with ASD, compared to 28 892 (1.92%) of 1 503 908 children born to mothers without RA. Maternal RA before delivery was associated with an increased risk of offspring ASD (HR = 1.43, 95% CI 1.11-1.84), especially for seronegative RA (HR = 1.61, 95% CI 1.12-2.30). No similar association was observed for paternal RA, maternal sisters with RA, or RA diagnosed after delivery. Maternal arthralgia displayed as high risks for offspring ASD as did maternal RA (HR = 1.41, 95% CI 1.24-1.60). CONCLUSIONS: In Sweden, maternal RA before delivery was associated with an increased risk of offspring ASD. The comparable association between maternal arthralgia and ASD risk suggests other pathways of risk than autoimmunity/inflammation, acting jointly or independently of RA.


Assuntos
Artrite Reumatoide , Transtorno do Espectro Autista , Transtorno Autístico , Efeitos Tardios da Exposição Pré-Natal , Masculino , Criança , Feminino , Humanos , Transtorno do Espectro Autista/etiologia , Transtorno do Espectro Autista/complicações , Estudos de Coortes , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Estudos Prospectivos , Artrite Reumatoide/epidemiologia , Artrite Reumatoide/complicações , Artrite Reumatoide/diagnóstico , Inflamação/complicações , Artralgia/complicações , Fatores de Risco
7.
JAMA Netw Open ; 6(2): e230233, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-36809471

RESUMO

This cross-sectional study uses electronic health record data to compare monthly incidence rates of spontaneous abortion in Israel before and during the COVID-19 pandemic.


Assuntos
Aborto Induzido , Aborto Espontâneo , COVID-19 , Gravidez , Feminino , Humanos , Aborto Espontâneo/epidemiologia , Israel , Pandemias
8.
Eur Psychiatry ; 66(1): e15, 2023 01 16.
Artigo em Inglês | MEDLINE | ID: mdl-36645097

RESUMO

BACKGROUND: Mental and physical health conditions are frequently comorbid. Despite the widespread physiological and behavioral changes during pregnancy, the pattern of comorbidities among women in pregnancy is not well studied. This study aimed to systematically examine the associations between mental and somatic disorders before and during pregnancy. METHOD: The study used data from mothers of a nationally representative birth cohort of children born in Israel (1997-2008). We compared the risk of all major somatic disorders (International Classification of Diseases, Ninth Revision) in pregnant women with and without a mental disorder. All analyses were adjusted for maternal age, child's birth year, family socioeconomic status, and the total number of maternal encounters with health services around pregnancy period. RESULTS: The analytical sample included 77,030 mother-child dyads, with 30,083 unique mothers. The mean age at child's birth was 29.8 years. Prevalence of diagnosis of mental disorder around pregnancy in our sample was 4.4%. Comorbidity between mental and somatic disorders was two times higher than the comorbidity between pairs of different somatic disorders. Of the 17 somatic disorder categories, seven were positively associated with mental health disorders. The highly prevalent comorbidities associated with mental disorders in pregnancy included e.g. musculoskeletal (OR = 1.30; 95% CI = 1.20-1.42) and digestive system diseases (OR = 1.23; 95% CI = 1.13-1.34). CONCLUSIONS: We observed that associations between maternal diagnoses and mental health stand out from the general pattern of comorbidity between nonmental health diseases. The study results confirm the need for screening for mental disorders during pregnancy and for potential comorbid conditions associated with mental disorders.


Assuntos
Transtornos Mentais , Feminino , Humanos , Gravidez , Adulto , Transtornos Mentais/epidemiologia , Comorbidade , Mães/psicologia , Saúde Mental , Idade Materna
9.
J Sex Marital Ther ; 49(6): 673-699, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36593754

RESUMO

Two Dutch studies formed the foundation and the best available evidence for the practice of youth medical gender transition. We demonstrate that this work is methodologically flawed and should have never been used in medical settings as justification to scale this "innovative clinical practice." Three methodological biases undermine the research: (1) subject selection assured that only the most successful cases were included in the results; (2) the finding that "resolution of gender dysphoria" was due to the reversal of the questionnaire employed; (3) concomitant psychotherapy made it impossible to separate the effects of this intervention from those of hormones and surgery. We discuss the significant risk of harm that the Dutch research exposed, as well as the lack of applicability of the Dutch protocol to the currently escalating incidence of adolescent-onset, non-binary, psychiatrically challenged youth, who are preponderantly natal females. "Spin" problems-the tendency to present weak or negative results as certain and positive-continue to plague reports that originate from clinics that are actively administering hormonal and surgical interventions to youth. It is time for gender medicine to pay attention to the published objective systematic reviews and to the outcome uncertainties and definable potential harms to these vulnerable youth.


Assuntos
Etnicidade , Identidade de Gênero , Criança , Adolescente , Feminino , Humanos
11.
Pharmacopsychiatry ; 56(1): 18-24, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35896419

RESUMO

INTRODUCTION: The Young Mania Rating Scale (YMRS) is the gold standard to assess manic symptoms of bipolar disorder, yet the clinical meaning of scores is unknown. To clinically understand and interpret YMRS scores, we examined linkages between the total and change scores of YMRS with the Clinical Global Impression (CGI) ratings. METHODS: Individual participant data (N=2,988) from eight randomized, double-blind, placebo-controlled trials were included. Data were collected at baseline and subsequent visits. Spearman's correlation coefficients ρ were computed, and equipercentile linking was implemented. RESULTS: A YMRS score of 6 points corresponded approximately to 'borderline mentally ill,' 12 points to 'mildly ill,' 20 points to 'moderately ill,' 30 points to 'markedly ill,' 40 points to 'severely ill,' and 52 points to 'among the most extremely ill' patients on the CGI-S. A reduction of CGI-S by one point as well as 'minimally improved' on the CGI-I corresponded approximately to an absolute decrease of 4 to 8 YMRS points or a 21% to 29% reduction of YMRS baseline score whereas a reduction of CGI-S by two points and 'much improved' on the CGI-I corresponded to an absolute decrease of 10 to 15 points or a 42% to 53% reduction of YMRS baseline score. DISCUSSION: The current study findings offer clinicians meaningful cutoff values to interpret YMRS scores. Moreover, these values contribute to the definition of treatment targets, response, remission, and entry criteria in mania trials.


Assuntos
Transtorno Bipolar , Mania , Humanos , Transtorno Bipolar/diagnóstico , Transtorno Bipolar/tratamento farmacológico , Método Duplo-Cego , Escalas de Graduação Psiquiátrica , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto
12.
Psychol Med ; 53(11): 4943-4951, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-35680620

RESUMO

BACKGROUND: The COVID-19 pandemic has been associated with increased levels of depression and anxiety with implications for the use of antidepressant medications. METHODS: The incident rate of antidepressant fills before and during the COVID-19 pandemic were compared using interrupted time-series analysis followed by comprehensive sensitivity analyses on data derived from electronic medical records from a large health management organization providing nationwide services to 14% of the Israeli population. The dataset covered the period from 1 January 2013 to 1 February 2021, with 1 March 2020 onwards defined as the period of the COVID-19 pandemic. Forecasting analysis was implemented to test the effect of the vaccine roll-out and easing of social restrictions on antidepressant use. RESULTS: The sample consisted of 852 233 persons with a total antidepressant incident fill count of 139 535.4 (total cumulative rate per 100 000 = 16 372.91, 95% CI 16 287.19-16 459.01). We calculated the proportion of antidepressant prescription fills for the COVID-19 period, and the counterfactual proportion for the same period, assuming COVID-19 had not occurred. The difference in these proportions was significant [Cohen's h = 10-3 (0.16), 95% CI 10-3 ( - 0.71 to 1.03)]. The pandemic was associated with a significant increase in the slope of the incident rate of antidepressant fills (slope change = 0.01, 95% CI 0.00-0.03; p = 0.04) and a monthly increase of 2% compared to the counterfactual (the estimated rate assuming no pandemic occurred). The increased rate was more pronounced in women, and was not modified by lockdown on/off periods, socioeconomic or SARS-CoV-2 status. The rate of observed antidepressant fills was similar to that forecasted under the assumption of ongoing COVID-19 distress. CONCLUSION: These findings underscore the toll of the pandemic on mental health and inform mental health policy and service delivery during and after implementing COVID-19 attenuation strategies.


Assuntos
COVID-19 , Humanos , Feminino , COVID-19/epidemiologia , SARS-CoV-2 , Pandemias/prevenção & controle , Controle de Doenças Transmissíveis , Antidepressivos/uso terapêutico
13.
Psychol Med ; 53(6): 2485-2491, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-34664545

RESUMO

BACKGROUND: To characterize the association between the protracted biopsychosocial coronavirus disease 2019 (COVID-19) pandemic exposures and incident suicide attempt rates. METHODS: Data were from a nationally representative cohort based on electronic health records from January 2013 to February 2021 (N = 852 233), with an interrupted time series study design. For the primary analysis, the effect of COVID-19 pandemic on incident suicide attempts warranting in-patient hospital treatment was quantified by fitting a Poisson regression and modeling the relative risk (RR) and the corresponding 95% confidence intervals (CIs). Scenarios were forecast to predict attempted suicide rates at 10 months after social mitigation strategies. Fourteen sensitivity analyses were performed to test the robustness of the results. RESULTS: Despite the increasing trend in the unexposed interval, the interval exposed to the COVID-19 pandemic was statistically significant (p < 0.001) associated with a reduced RR of incident attempted suicide (RR = 0.63, 95% CI 0.52-0.78). Consistent with the primary analysis, sensitivity analysis of sociodemographic groups and methodological factors were statistically significant (p < 0.05). No effect modification was identified for COVID-19 lockdown intervals or COVID-19 illness status. All three forecast scenarios at 10 months projected a suicide attempt rate increase from 12.49 (7.42-21.01) to 21.38 (12.71-35.99). CONCLUSIONS: The interval exposed to the protracted mass social trauma of the COVID-19 pandemic was associated with a lower suicide attempt rate compared to the unexposed interval. However, this trend is likely to reverse 10 months after lifting social mitigation policies, underscoring the need for enhanced implementation of public health policy for suicide prevention.


Assuntos
COVID-19 , Tentativa de Suicídio , Humanos , Tentativa de Suicídio/psicologia , COVID-19/epidemiologia , Pandemias , Análise de Séries Temporais Interrompida , Controle de Doenças Transmissíveis
14.
Am J Geriatr Psychiatry ; 31(5): 315-323, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-35718587

RESUMO

OBJECTIVES: To examine the association between prescription opioid use and the risk of dementia in old-age, since existing studies of the association are few, and the evidence is inconsistent. DESIGN: Prospective national cohort study (N = 91,307, aged 60 years and over), without a dementia diagnosis for ten years, followed-up for incident dementia from January 2013 to October 2017. MEASUREMENTS: Opioid exposure was based on opioid purchases classified from Anatomical Therapeutic Chemical Classification system codes (N02A), and classified as exposed if the purchase period covered at least 60 days within a 120-day interval; otherwise, unexposed. SETTING: Healthcare maintenance organization in Israel. RESULTS: During follow-up, 2,849 (3.1%) persons were opioid exposed (mean age 73.94 ± 6.71 years), and 5,298 (5.8 %) persons developed dementia (mean age 78.07 ± 6.54 years). Cox regression models were fitted to quantify the risk of incident dementia with Hazard Ratios (HR) and their associated 95% Confidence Intervals (CI). The opioid exposed group aged 75+ to 80 years were at an increased risk of incident dementia (Adjusted HR = 1.39, 95% CI = 1.01, 1.92, Z-statistic = 2.02, p <0.05) compared to the unexposed. The point-precision estimates were generally similar to the primary analysis across fourteen sensitivity analyses. CONCLUSION: Policymakers, caregivers, patients, and clinicians may wish to consider that opioid exposure aged 75-80 is linked with an increased dementia risk to balance the potential benefits and adverse side effects of opioid use in old age.


Assuntos
Demência , Transtornos Relacionados ao Uso de Opioides , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Demência/induzido quimicamente , Demência/epidemiologia , Analgésicos Opioides/efeitos adversos , Estudos Prospectivos , Fatores de Risco
15.
Artigo em Inglês | MEDLINE | ID: mdl-36498141

RESUMO

The identification of demographic factors of vulnerability and resilience in communities facing belligerent conflicts is increasingly relevant today. This representative study aims to examine the effect of protracted violence on the level of fear of the overall Israeli-Jewish population, and the role of the conflict on the connection between socio-economic factors and fears. Sixty-six representative samples were identified and surveyed from 2001 to 2019 (n = 37,190) that occurred during (n = 14,362) and between (n = 22,828) seven conflicts and non-conflict periods. Results show that during military conflicts, civilians declared less fears of physical injury comparing routine time; a slow trend of decline in the level of fears over time was observed; during routine periods, fear was associated with female-gender and with the lowest income level group. Ultra-orthodox and Religious respondents had significantly less fear than the secular and traditional respondents. During military conflicts, the results changed significantly, mainly for the lowest income group, women and ultra-orthodox.


Assuntos
Judeus , Judaísmo , Feminino , Humanos , Medo , Inquéritos e Questionários , Agressão , Israel/epidemiologia
16.
Emerg Themes Epidemiol ; 19(1): 9, 2022 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-36369014

RESUMO

BACKGROUND: Interrupted time series (ITS) analysis is a time series regression model that aims to evaluate the effect of an intervention on an outcome of interest. ITS analysis is a quasi-experimental study design instrumental in situations where natural experiments occur, gaining popularity, particularly due to the Covid-19 pandemic. However, challenges, including the lack of a control group, have impeded the quantification of the effect size in ITS. The current paper proposes a method and develops a user-friendly R package to quantify the effect size of an ITS regression model for continuous and count outcomes, with or without seasonal adjustment. RESULTS: The effect size presented in this work, together with its corresponding 95% confidence interval (CI) and P-value, is based on the ITS model-based fitted values and the predicted counterfactual (the exposed period had the intervention not occurred) values. A user-friendly R package to fit an ITS and estimate the effect size was developed and accompanies this paper. To illustrate, we implemented a nation population-based ITS study from January 2001 to May 2021 covering the all-cause mortality of Israel (n = 9,350 thousand) to quantify the effect size of Covid-19 exposure on mortality rates. In the period unexposed to the Covid-19 pandemic, the mortality rate decreased over time and was expected to continue decreasing had Covid-19 not occurred. In contrast, the period exposed to the Covid-19 pandemic was associated with an increased all-cause mortality rate (relative risk = 1.11, 95% CI = 1.04, 1.18, P < 0.001). CONCLUSION: For the first time, the effect size in ITS: was quantified, can be estimated by end-users with an R package we developed, and was demonstrated with data showing an increase in mortality following the Covid-19 pandemic. ITS effect size reporting can assist public health policy makers in assessing the magnitude of the entire intervention effect using a single, readily understood measure.

17.
Stat Med ; 41(17): 3299-3320, 2022 07 30.
Artigo em Inglês | MEDLINE | ID: mdl-35472818

RESUMO

The number needed to treat (NNT) is an efficacy index commonly used in randomized clinical trials. The NNT is the average number of treated patients for each undesirable patient outcome, for example, death, prevented by the treatment. We introduce a systematic theoretically-based framework to model and estimate the conditional and the harmonic mean NNT in the presence of explanatory variables, in various models with dichotomous and nondichotomous outcomes. The conditional NNT is illustrated in a series of four primary examples; logistic regression, linear regression, Kaplan-Meier estimation, and Cox regression models. Also, we establish and prove mathematically the exact relationship between the conditional and the harmonic mean NNT in the presence of explanatory variables. We introduce four different methods to calculate asymptotically-correct confidence intervals for both indices. Finally, we implemented a simulation study to provide numerical demonstrations of the aforementioned theoretical results and the four examples. Numerical analysis showed that the parametric estimators of the NNT with nonparametric bootstrap-based confidence intervals outperformed other examined combinations in most settings. An R package and a web application have been developed and made available online to calculate the conditional and the harmonic mean NNTs with their corresponding confidence intervals.


Assuntos
Modelos de Riscos Proporcionais , Humanos , Modelos Logísticos
18.
Evid Based Ment Health ; 25(2): 63-68, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35292483

RESUMO

BACKGROUND: The association between serum folate deficiency and the risk of dementia in old age is unclear, perhaps owing to small sample sizes, the competing risk of mortality or reverse causation. OBJECTIVE: To examine the associations between serum folate deficiency and the risks of incident dementia and all-cause mortality in a large national sample of older adults. METHODS: A prospective cohort aged 60-75 years (n=27 188) without pre-existing dementia for at least 10 years, was tested for serum concentrations of folate and followed up for dementia or all-cause mortality. Serum folate deficiency was classified as present (<4.4 ng/mL), otherwise absent. HRs and 95% CIs from competing risks Cox models were fitted to quantify the associations between serum folate deficiency and the risks of dementia and all-cause mortality. To examine reverse causation, the analysis was stratified by duration of follow-up. FINDINGS: The presence compared with the absence of serum folate deficiency was associated with higher risks of dementia (HR=1.68; 95% CI 1.32 to 2.13; p<0.001) and all-cause mortality (HR=2.98; 95% CI 2.52 to 3.52; p<0.001). Evidence for reverse causation were moderate for dementia and mild for all-cause mortality. CONCLUSIONS: Serum concentrations of folate may function as a biomarker used to identify those at risk of dementia and mortality; however, reverse causation is likely. Further research is needed to examine the role of serum folate deficiency in dementia aetiology. CLINICAL IMPLICATIONS: Serum folate deficiency in older adults requires monitoring and treatment for preventative measures and/or as part of implemented therapeutic strategies.


Assuntos
Demência , Deficiência de Ácido Fólico , Idoso , Demência/etiologia , Ácido Fólico/uso terapêutico , Deficiência de Ácido Fólico/complicações , Deficiência de Ácido Fólico/tratamento farmacológico , Humanos , Modelos de Riscos Proporcionais , Estudos Prospectivos
19.
J Sex Marital Ther ; 48(7): 706-727, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35300570

RESUMO

In less than a decade, the western world has witnessed an unprecedented rise in the numbers of children and adolescents seeking gender transition. Despite the precedent of years of gender-affirmative care, the social, medical and surgical interventions are still based on very low-quality evidence. The many risks of these interventions, including medicalizing a temporary adolescent identity, have come into a clearer focus through an awareness of detransitioners. The risks of gender-affirmative care are ethically managed through a properly conducted informed consent process. Its elements-deliberate sharing of the hoped-for benefits, known risks and long-term outcomes, and alternative treatments-must be delivered in a manner that promotes comprehension. The process is limited by: erroneous professional assumptions; poor quality of the initial evaluations; and inaccurate and incomplete information shared with patients and their parents. We discuss data on suicide and present the limitations of the Dutch studies that have been the basis for interventions. Beliefs about gender-affirmative care need to be separated from the established facts. A proper informed consent process can both prepare parents and patients for the difficult choices that they must make and can ease professionals' ethical tensions. Even when properly accomplished, however, some clinical circumstances exist that remain quite uncertain.


Assuntos
Consentimento Livre e Esclarecido , Transexualidade , Adolescente , Criança , Compreensão , Identidade de Gênero , Humanos , Princípios Morais , Adulto Jovem
20.
BJPsych Open ; 8(2): e35, 2022 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-35101158

RESUMO

BACKGROUND: Evidence from various sources suggests that females with schizophrenia tend to report lower quality of life than males with schizophrenia despite having a less severe course of the disorder. However, studies have not examined this directly. AIMS: To examine gender differences in the association between quality of life and the risk of subsequent psychiatric hospital admissions in a national sample with schizophrenia. METHOD: The sample consisted of 989 (60.90%) males and 635 (39.10%) females with an ICD-10 diagnosis of schizophrenia. Quality of life was assessed and scored using the Manchester Short Assessment of Quality of Life. The course of schizophrenia was assessed from the number of psychiatric hospital admissions. Participants completed the quality of life assessment and were then followed up for 18-months for subsequent psychiatric admissions. Hazard ratios (HR) from Cox proportional hazards regression models were estimated unadjusted and adjusted for covariates (age at schizophrenia onset and birth year). Analyses were computed for males and females separately, as well as for the entire cohort. RESULTS: A subsample of 93 males and 55 females was admitted to a psychiatric hospital during follow-up. Higher quality of life scores were significantly (P < 0.05) associated with a reduced risk of subsequent admissions among males (unadjusted: HR = 0.96, 95% CI 0.93-0.99; adjusted HR = 0.96, 95% CI 0.93-0.99) but not among females (unadjusted: HR = 0.97, 95% CI 0.93-1.02; adjusted HR = 0.97, 95% CI 0.93-1.02). CONCLUSIONS: Quality of life in schizophrenia is a gender-specific construct and should be considered as such in clinical practice and future research.

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