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1.
Medicina (Kaunas) ; 58(6)2022 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-35744001

RESUMO

Background and Objectives: One form of treatment for degenerative temporomandibular joint diseases such as osteoarthritis, rheumatic arthritis, TMJ ankylosis, and condylar resorption is total joint replacement. The aim of this study was to examine the function of the temporomandibular joint after prosthetic joint replacement. Materials and methods: Fifteen patients with unilateral or bilateral TMJ total joint replacements and 15 healthy controls were evaluated via a SICAT JMT+ device. This non-invasive system measures 3D position and linear movements in all degrees of freedom and allows undisturbed functional mandibular movements to provide a quantitative evaluation. In addition, a TMJ questionnaire consisting of the subjective symptoms was also obtained. To date, no similar studies have been cited in the literature. Results: Mandibular movements after prosthetic joint replacement were recorded during opening, closing, protrusion, and lateral excursive movements and were all significantly decreased compared to those of controls. In the treatment group, the maximum incisal opening was 33.46 ± 5.47 mm, left lateral movement was 1.91 ± 2.7 mm, right lateral movement was 1.74 ± 1.74 mm, and protrusive movement was 2.83 ± 2.05 mm. The p-value comparison study and control group indicated significant difference (p < 0.0001) between the two groups. The study group stated a high level of satisfaction with the total joint replacement. Conclusion: Within the limitations of the study, the following conclusions can be drawn: (1) TMJ replacement patients showed significantly limited jaw movements compared to the control group; (2) a small percentage of TMJ replacement patients still present low levels of pain but improved chewing ability and quality of life.


Assuntos
Artroplastia de Substituição , Transtornos da Articulação Temporomandibular , Grupos Controle , Humanos , Qualidade de Vida , Amplitude de Movimento Articular , Articulação Temporomandibular/cirurgia , Transtornos da Articulação Temporomandibular/cirurgia
2.
BMC Med Res Methodol ; 22(1): 152, 2022 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-35643430

RESUMO

BACKGROUND: Observational data are increasingly being used to conduct external comparisons to clinical trials. In this study, we empirically examined whether different methodological approaches to longitudinal missing data affected study conclusions in this setting. METHODS: We used data from one clinical trial and one prospective observational study, both Norwegian multicenter studies including patients with recently diagnosed rheumatoid arthritis and implementing similar treatment strategies, but with different stringency. A binary disease remission status was defined at 6, 12, and 24 months in both studies. After identifying patterns of longitudinal missing outcome data, we evaluated the following five approaches to handle missingness: analyses of patients with complete follow-up data, multiple imputation (MI), inverse probability of censoring weighting (IPCW), and two combinations of MI and IPCW. RESULTS: We found a complex non-monotone missing data pattern in the observational study (N = 328), while missing data in the trial (N = 188) was monotone due to drop-out. In the observational study, only 39.0% of patients had complete outcome data, compared to 89.9% in the trial. All approaches to missing data indicated favorable outcomes of the treatment strategy in the trial and resulted in similar study conclusions. Variations in results across approaches were mainly due to variations in estimated outcomes for the observational data. CONCLUSIONS: Five different approaches to handle longitudinal missing data resulted in similar conclusions in our example. However, the extent and complexity of missing observational data affected estimated comparative outcomes across approaches, highlighting the need for careful consideration of methods to account for missingness in this setting. Based on this empirical examination, we recommend using a prespecified advanced missing data approach to account for longitudinal missing data, and to conduct alternative approaches in sensitivity analyses.


Assuntos
Modelos Estatísticos , Projetos de Pesquisa , Grupos Controle , Humanos , Probabilidade
3.
Comput Intell Neurosci ; 2022: 8555489, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35401736

RESUMO

Major depressive disorder (MDD) is a mood state that is not usually associated with vision problems. Recent research has found that the inhibitory neurotransmitter GABA levels in the occipital brain have dropped. Aim. The aim of the research is to evaluate mental workload by single channel electroencephalogram (EEG) approach through visual-motor activity and comparison of parameter among depressive disorder patient and in control group. Method. Two tests of a visual-motor task similar to reflect drawings were performed in this study to compare the visual information processing of patients with depression to that of a placebo group. The current study looks into the accuracy of monitoring cognitive burden with single-channel portable EEG equipment. Results. The alteration of frontal brain movement in reaction to fluctuations in cognitive burden stages generated through various vasomotor function was examined. By applying a computerised oculomotor activity analogous to reflector image diagram, we found that the complexity of the path to be drawn was more important than the real time required accomplishing the job in determining perceived difficulty in depressive disorder patients. The overall perceived difficulty of the exercise is positively linked with EEG activity measured from the motor cortex region at the start of every experiment test. The average rating for task completion for depression patients and in control group observed and no statistical significance association reported between rating scale and time spent on each trial (p=1.43) for control group while the normalised perceived difficulty rating had 0.512, 0.623, and 0.821 correlations with the length of the pathway, the integer of inclination in the pathway, and the time spent to complete every experiment test, respectively (p < 0.0001) among depression patients. The findings imply that alterations in comparative cognitive burden levels during an oculomotor activity considerably modify frontal EEG spectrum. Conclusion. Patients with depression perceived the optical illusion in the arrays as weaker, resulting in a little bigger disparity than individuals who were not diagnosed with depression. This discovery provided light on the prospect of adopting a user-friendly mobile EEG technology to assess mental workload in everyday life.


Assuntos
Transtorno Depressivo Maior , Grupos Controle , Eletroencefalografia/métodos , Humanos , Atividade Motora , Carga de Trabalho/psicologia
4.
Trials ; 23(1): 347, 2022 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-35461281

RESUMO

BACKGROUND: Prevalence of posttraumatic stress disorder (PTSD) in refugees is reportedly higher in comparison to the general population. Refugee children specifically are often coping with trauma and loss and are at risk for mental health difficulties. With staggering numbers of people seeking refuge around the world and 50% being 18 years or younger, research examining the effects of trauma-focused therapies for refugee children with PTSD is highly needed. Both Eye Movement Desensitization and Reprocessing (EMDR) therapy and the child version of Narrative Exposure Therapy (KIDNET) have been used for refugees, although these treatment methods have not been systematically compared. The aim of the current study is to investigate the effectiveness of EMDR and KIDNET, compared to a waitlist control group and with each other, offered to refugee children. METHODS: A randomized controlled three-arm trial has been designed. The primary outcome is PTSD diagnosis and symptom severity assessed with the Clinician-Administered PTSD Scale for Children DSM5 (CAPS-CA-5) at baseline (T1), 1 month post-treatment, or after 8 weeks of waiting (T2) and 3 months follow-up (T3). Additionally, instruments to assess posttraumatic stress symptoms, behavioral and emotional problems, and quality of life perception in children aged 8-18 are conducted at T1, T2, and T3. DISCUSSION: This is the first RCT that examines the effectiveness of EMDR and KIDNET in refugee children aged 8-18 years specifically, compared to a waitlist control group intended to reduce PTSD diagnosis and severity of posttraumatic stress symptoms and comorbid complaints in a growing and challenging population. TRIAL REGISTRATION: Dutch Trial Register NL40769 . Retrospectively registered on June 16, 2021.


Assuntos
Dessensibilização e Reprocessamento através dos Movimentos Oculares , Terapia Implosiva , Refugiados , Transtornos de Estresse Pós-Traumáticos , Criança , Grupos Controle , Dessensibilização e Reprocessamento através dos Movimentos Oculares/métodos , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Transtornos de Estresse Pós-Traumáticos/diagnóstico , Transtornos de Estresse Pós-Traumáticos/psicologia , Transtornos de Estresse Pós-Traumáticos/terapia , Resultado do Tratamento
5.
Am J Sports Med ; 50(6): 1571-1581, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35438028

RESUMO

BACKGROUND: The incidence of revision hip arthroscopy with labral reconstruction in athletes is increasing. However, the outcomes of revision hip arthroscopy with labral reconstruction in athletes have not been well established. PURPOSES: (1) To report minimum 2-year patient-reported outcome (PRO) scores and return to sports (RTS) characteristics for high-level athletes undergoing revision hip arthroscopy with labral reconstruction and (2) to compare clinical results with those of a propensity-matched control group of high-level athletes undergoing revision hip arthroscopy with labral repair. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Data were prospectively collected and retrospectively reviewed for athletes at any level who underwent a revision hip arthroscopy and a labral reconstruction between April 2010 and March 2019. Minimum 2-year PROs were reported for the modified Harris Hip Score (mHHS), the Nonarthritic Hip Score (NAHS), the Hip Outcome Score-Sport Specific Subscale (HOS-SSS), the visual analog scale (VAS) for pain, and RTS. The percentages of athletes achieving the minimal clinically important difference (MCID) and the maximum outcome improvement satisfaction threshold (MOIST) were also recorded. These patients were propensity matched in a 1: 1 ratio to athletes undergoing revision hip arthroscopy with labral repair for comparison. RESULTS: A total of 46 athletes (N = 47 hips) were reported from 50 (n = 51 hips) athletes who underwent revision with labral reconstruction. A subanalysis of 30 propensity-matched athletes undergoing revision labral reconstruction was performed, with a mean follow-up time of 26.3 ± 2.4 months and an age of 28.5 ± 10.1 years, and compared with a revision labral repair group. Significant improvements were obtained for the mHHS, the NAHS, the HOS-SSS, and the VAS from preoperative to the latest follow-up (P < .001), with an achievement MCID rate of 61.5%, 72%, 62.5%, and 76.9% for the mHHS, the NAHS, the HOS-SSS, and the VAS, respectively. The rate for re-revision surgery (2 tertiary arthroscopy and 1 conversion to total hip arthroplasty) was 10%, and 14 patients (63.6%) were able to RTS. Improvements in PROs, rates of achieving MCID/MOIST, rate of re-revision surgery (re-revision hip arthroscopy, P = .671; conversion to total hip arthroplasty, P > .999), and RTS rate (P = .337) were similar when compared with those of the propensity-matched control labral repair group (P > .05). CONCLUSION: Revision hip arthroscopy with labral reconstruction, in the context of an irreparable labral tear, seems to be a valid treatment option in the athletic population, demonstrating significant improvements in all PROs and low rates of undergoing revision surgery. Athletes experienced a similar magnitude of improvement in PROs, RTS rate, and revision surgery rate to that of a propensity-matched control group of athletes undergoing revision hip arthroscopy with labral repair.


Assuntos
Artroscopia , Impacto Femoroacetabular , Adolescente , Adulto , Atletas , Benchmarking , Estudos de Coortes , Grupos Controle , Impacto Femoroacetabular/cirurgia , Seguimentos , Articulação do Quadril/cirurgia , Humanos , Medidas de Resultados Relatados pelo Paciente , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
6.
J Psychosom Res ; 156: 110777, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35259551

RESUMO

OBJECTIVE: This cross-sectional study was designed to add to the emerging empirical literature characterizing the psychiatric and audiologic features of misophonia. Because most research to date has not compared misophonia to clinical control groups, the present study used both participants who did not report any sound intolerance problems and a clinical control group of participants with auditory over-responsivity not formally meeting criteria for a diagnosis of misophonia using proposed diagnostic criteria by Schroeder et al. (2013). Severity of misophonia symptoms, frequency of current or lifetime psychiatric disorders, loudness discomfort, and hearing loss were compared across groups. METHODS: Structured interviews, questionnaires, and objective measures of audiologic functioning were administered to a sample of adult participants (N = 156). Measures included an interviewer-rated diagnostic assessment of misophonia, the MisoQuest, (Siepsiak et al., 2020), M.I.N·I (Sheehan et al., 1998), loudness discomfort level (LDL), and hearing loss (PTA). RESULTS: Group differences in misophonia symptom severity among all three groups were observed: FWelch (2,50.57) = 149.92, p < .001, n2 = 0.64, validating group assignment. Psychiatric disorders were significantly more frequent in the misophonia group (71%) than in the auditory over-responsivity group (40%) and control group (40%): X2 (2, N = 142) = 14.3; p = .001; V = 0.317. A wide range of psychiatric disorders were observed in the misophonia group, (e.g., major depressive episode, suicidality and panic disorder were the most common). There were no significant differences between groups with regards to audiologic functioning. CONCLUSION: Misophonia co-occurs with a variety of psychiatric disorders but does not appear to be associated with loudness discomfort or hearing impairments.


Assuntos
Transtorno Depressivo Maior , Adulto , Grupos Controle , Estudos Transversais , Humanos , Hiperacusia , Transtornos Fóbicos
7.
Contemp Clin Trials ; 115: 106703, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35176501

RESUMO

Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.


Assuntos
Ensaios Clínicos Pragmáticos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Análise por Conglomerados , Grupos Controle , Humanos , Ensaios Clínicos Pragmáticos como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Pesquisadores
8.
Rev. bras. ortop ; 57(1): 150-158, Jan.-Feb. 2022. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1365739

RESUMO

Abstract Objective To compare the techniques for the osteosynthesis of intertrochanteric fractures with dynamic hip screws (DHSs) through the Hardinge and minimally-invasive access routes of the hip, evaluating the operative time, the degree of pain in the immediate postoperative period, the hematimetric loss, and the functional aspects of active mobility. Methods A randomized, double-blinded clinical trial in which 66 patients with intertrochanteric fractures were submitted to osteosynthesis by DHS. The patients were divided into a test group, submitted to the minimally-invasive access, and a control group, in whom the surgery was performed through the Hardinge route. Results Patients submitted to the minimally-invasive treatment presented a lower degree of postoperative pain compared to the group treated by the Hardinge lateral route (p< 0.001), as well as lower hematimetric loss (p< 0.001), shorter operative time (p< 0.001), and improvement in immediate postoperative active mobility tests (p <0.05). Conclusion The study demonstrated the clinical superiority of the minimally-invasive access route parameters analyzed in relation to the Hardinge access for the fixation of intertrochanteric fractures when DHS is the choice osteosynthesis method. Level of evidence I.


Resumo Objetivo Comparar as técnicas de osteossíntese de fraturas intertrocantéricas com o parafuso dinâmico de quadril (dynamic hip screw, DHS, em inglês) pelas vias de acesso de Hardinge e minimamente invasiva do quadril, avaliando o tempo cirúrgico, o grau de dor no pós-operatório imediato, a perda hematimétrica, e os aspectos funcionais de mobilidade ativa. Métodos Estudo clínico randomizado e duplo-cego, em que 66 pacientes com fratura intertrocantérica foram submetidos a osteossíntese com DHS. Os pacientes foram divididos em um grupo teste, submetidos ao acesso minimamente invasivo, e um controle, em que a cirurgia foi realizada pela via de Hardinge. Resultados Os pacientes submetidos ao tratamento pela via minimamente invasiva apresentaram um grau de dor pós-operatória inferior em comparação ao grupo tratado pela via lateral de Hardinge (p< 0,001), assim como menor perda hematimétrica (p< 0,001), menor tempo operatório (p< 0,001), e melhora nos testes de mobilidade ativa pós-operatória imediata (p< 0,05). Conclusão O estudo demonstrou a superioridade clínica nos parâmetros analisados da via de acesso minimamente invasiva em relação ao acesso de Hardinge para a fixação de fraturas intertrocantéricas, quando o DHS for a opção de osteossíntese escolhida. Nível de evidência I.


Assuntos
Humanos , Masculino , Feminino , Idoso , Idoso de 80 Anos ou mais , Dor Pós-Operatória , Período Pós-Operatório , Grupos Controle , Ensaio Clínico , Procedimentos Cirúrgicos Minimamente Invasivos , Fixação Interna de Fraturas , Fraturas do Quadril
9.
Epidemiol Infect ; 150: e53, 2022 01 07.
Artigo em Inglês | MEDLINE | ID: mdl-34991764

RESUMO

Established methods of recruiting population controls for case-control studies in infectious disease outbreak investigations are resource- and time-intensive, and are often subject to bias. The online panel have recently gained interest as an easy and timely method to select controls. We examined the feasibility, suitability and reliability of using an online panel to select controls for case-control studies as part of investigations of diffuse food and waterborne outbreaks. In January 2019, we deployed a web survey by email to the 277 members of a non-probabilistic online panel in Lower Saxony, Germany. We questioned them on basic sociodemographic characteristics and eating habits. They were frequency matched to cases on sex and age. Their food exposures were compared to those of traditionally recruited controls of four historical case-controls studies, which successfully investigated food and waterborne outbreaks. We used logistic regressions to assess the association between the food exposures and the disease (odds ratios). The use of a control panel successfully led to the identification of the food items in three of the four historical outbreak investigations, and their recruitment benefitted from increased speed and limited costs. Timely outbreak investigations would enable rapidly implementing control measures. We recommend the further evaluation of using panellists as controls in parallel case-control studies and case-panel studies.


Assuntos
Surtos de Doenças , Estudos de Casos e Controles , Grupos Controle , Alemanha/epidemiologia , Reprodutibilidade dos Testes
10.
J Gen Intern Med ; 37(4): 862-869, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35025068

RESUMO

IMPORTANCE: Long-term health effects have been indicated following COVID-19; however, the impact of COVID-19 on health-related quality of life (HRQOL), including who may experience ongoing symptoms, is unknown. OBJECTIVE: To identify change in HRQOL following COVID-19 compared to pre-infection HRQOL and a matched control group, and identify predictors of patients who worsen. DESIGN: Retrospective pre-post cohort study with a matched control group. SETTING: Large healthcare system in northeast Ohio. PARTICIPANTS: A total of 3,690 adult patients diagnosed with COVID-19 who completed HRQOL surveys during routine care for ambulatory visits before and after infection. Propensity-score 1:1 match was utilized to identify controls without COVID who completed HRQOL at two time points. MAIN OUTCOMES: HRQOL was assessed with PROMIS Global Health: global mental and physical health summary scores. Pre- and post-COVID PROMIS Global Health was completed as part of routine care from 1/1/2019 to 2/29/2020 and 4/4/2020 to 11/1/2021, respectively, and extracted from the electronic health record. RESULTS: COVID-19 patients (mean age 53±15; 66% female) completed PROMIS Global Health in the year prior (median 11.1 months) and after diagnosis (median 7.8 months). Compared to before infection, COVID-19 patients had a significant reduction in global mental health and stable global physical health (-0.85 and 0.05 T-score points, respectively) with clinically meaningful reduction (≥5 T-score points) experienced by 27% and 23% of patients, respectively. Predictors of worsening global health included being female, having depression, being hospitalized for COVID-19, and better pre-COVID global health. Compared to the control group, there was significantly worse global mental and physical health decline following COVID-19 (-0.53 and -0.37 T-score points, respectively). CONCLUSIONS AND RELEVANCE: A quarter of patients with COVID-19 experienced meaningful reductions in HRQOL. Reductions in global mental and physical health were modest, although significantly worse than a control group. Additionally, identified predictors of patients who worsen may assist clinicians when counseling patients of their risk of worse HRQOL following COVID-19.


Assuntos
COVID-19 , Qualidade de Vida , Adulto , Idoso , Estudos de Coortes , Grupos Controle , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Retrospectivos , SARS-CoV-2
11.
Schizophr Res ; 240: 81-91, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34991042

RESUMO

There are discrepancies about if the severity of the symptomatology in schizophrenia is related to neurocognitive performance, functional outcome, and quality of life (QoL). Also, there are controversial data about the comparison between euthymic bipolar patients and different subgroups of schizophrenia in neurocognition, functioning, and QoL level. The present study aimed to compare the neurocognitive performance, functional outcome, and QoL of remitted and non-remitted patients with SC with respect to a group of euthymic patients with BD, and a control group. It included 655 subjects: 98 patients with schizophrenia in remission (SC-R), 184 non-remitted patients with schizophrenia (SC-NR), 117 euthymic patients with bipolar I disorder (BD), and 256 healthy subjects. A comprehensive clinical, neurocognitive (six cognitive domains), functional, and QoL assessment was carried out. Remission criteria of Andreasen were used to classify schizophrenia patients as remitted or non-remitted. Compared with control subjects all groups of patients showed impaired neurocognitive performance, functioning and QoL. SC-R patients had an intermediate functioning between control subjects and SC-NR, all at a neurocognitive, functional, or QoL level. There were no significant differences between SC-R and BD. These results suggest that reaching clinical remission is essential to achieve a better level of psychosocial functioning, and QoL. Likewise, the results of this study suggest that euthymic patients with bipolar disorder and patients with schizophrenia in remission are comparable at the neurocognitive and functional levels, which might have implications in the pathophysiology of both disorders.


Assuntos
Transtorno Bipolar , Esquizofrenia , Transtorno Bipolar/complicações , Transtorno Bipolar/psicologia , Grupos Controle , Humanos , Testes Neuropsicológicos , Qualidade de Vida , Esquizofrenia/complicações , Psicologia do Esquizofrênico
12.
Artigo em Inglês | MEDLINE | ID: mdl-35010722

RESUMO

The purpose of this study was to verify if a conditioning activity was effective to elicit postactivation performance enhancement (PAPE) and to increase the performance in vertical jump (VJ) in elite female volleyball players. Eleven national Superliga-2 volleyball players (22.6 ± 3.5 years) were randomly assigned to an experimental and control group. Countermovement jumps (CMJ) were performed on eight occasions: before (Pre-PAPE) and after activation (Post-PAPE), after the match (Pre-Match), and after each of the five-match sets (Set 1 to 5). ANOVA showed significantly increased jump performance for the experiment between baseline (Pre-PAPE) and all the following tests: +1.3 cm (Post-PAPE), +3.0 cm (Pre-Match), +4.8 cm (Set 1), +7.3 cm (Set 2), +5.1 cm (Set 3), +3.6 cm (Set 4), and +4.0 cm (Set 5), all showing medium to large effect size (0.7 < ES < 2.4). The performance of the control group did not show significant increases until Set 3 (+3.2 cm) and Set 5 (+2.9 cm), although jump heights were always lower for the control group than the experimental. The use of conditioning activity generates increased VJ performance in Post-PAPE tests and elicited larger PAPE effects that remain until the second set of a volleyball match.


Assuntos
Desempenho Atlético , Voleibol , Grupos Controle , Meios de Cultura , Feminino , Humanos , Força Muscular
13.
Pharm Stat ; 21(3): 625-640, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35060676

RESUMO

In early clinical development, randomized controlled trials (RCT) or single-arm trials with external controls (SATwEC) are design options, which allow adjustment for confounding: RCT via design, SATwEC via analysis using propensity score methods. SATwEC requires less investment than RCT. However, if the confounder space substantially differs between the experimental and external control group, the SATwEC might lead to inappropriate decisions for further development. We develop an adaptive two-stage design (ATD) for early clinical development that reduces the risk of unreliable decision-making at the end of a SATwEC. In Stage I, subjects are solely assigned to the experimental group. If at the interim the propensity score distributions of internal and external data are comparable based on the preference score, the subjects in stage II will again be solely assigned to the experimental arm; if not, a randomized stage II will be conducted. In a simulation study guided by a motivating example, data is generated using a time-to-event model with observable and unobservable confounders. The confounder space is varied to investigate the impact on false go/stop probabilities as well as a loss function, which reflects the quality of treatment effect estimates and decision-making. The proposed ATD provides a compromise between optimizing quality (as expressed by false go/stop probabilities and the loss function) and investment (defined by sample size and trial duration).


Assuntos
Projetos de Pesquisa , Simulação por Computador , Grupos Controle , Humanos , Pontuação de Propensão , Tamanho da Amostra
15.
Gait Posture ; 91: 223-228, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34741932

RESUMO

BACKGROUND: Lower limb amputation causes difficulties in mobility together with motor and sensory loss. Challenging situations such as concurrent tasks cause gait parameters to deteriorate. Understanding the effect of concurrent tasks on gait is important for the rehabilitation of amputees. RESEARCH QUESTION: Are the effects of concurrent cognitive and motor tasks on gait parameters at fixed speed different in individuals with transtibial amputation, or transfemoral amputation compared to healthy individuals? METHODS: The gait parameters were evaluated of 20 individuals with transtibial amputation, 13 individuals with transfemoral amputation and 20 healthy individuals while walking on a motorized treadmill under single task (ST), cognitive dual task (CDT) and motor dual task (MDT) conditions. The self-selected comfortable velocity, which was determined in the single-task gait, was used in all three walking tests. RESULTS: ST, CDT and MDT gait parameters of individuals with transtibial amputation, transfemoral amputation and healthy individuals were significantly different (p < 0.01). Covariance of step length variability increased in amputees when walking under MDT (p < 0.05). The dual task cost (DTC) for all the gait parameters was similar in all three groups (p > 0.05). The motor DTC of covariance of step length was greater than cognitive DTC (p < 0.05). SIGNIFICANCE: Individuals with lower limb amputation have the capacity to walk with cognitive and motor tasks without changing velocity on the treadmill, but concurrent motor tasks cause an increase in gait variability. The results of this study suggest that there is an increase in gait variability especially with motor tasks, which may cause a higher risk of falling. Trial number: NCT04392466 (clinicaltrials.gov).


Assuntos
Amputados , Membros Artificiais , Amputação , Cognição , Grupos Controle , Marcha , Humanos , Caminhada
16.
Andrologia ; 54(2): e14335, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34866223

RESUMO

We have identified patients among non-obstructive azoospermia (NOA) cases in whom spermatozoa could not be detected despite treatment, but intermittent ejaculatory spermatozoon was found in their follow-up. NOA was observed in the retrospective screening at a rate of 15.35% among infertile men (n = 1976/12,871), while non-obstructive intermittent azoospermia (NO-IA) was detected at a rate of 6.8% among NO-IA (n = 135/1976) and 1.1% among all infertile men (n = 135/12,871). Spermatozoon was identified in the form of cryptospermia or extreme oligospermia in 58.13 (13.6-92.3) weeks on average in n = 55/135 patients among NO-IA. Pregnancy and live birth were achieved at a rate of 43.6% (n = 24/55) and 29% (n = 16/55), respectively, in intracytoplasmic sperm injection. NO-IA was composed of a group with no genetic pathological diagnosis, with lower follicle-stimulating hormone, lutenizing hormone and clinical varicocele rates compared with those of NOA (<0.05) and higher testicular volumes and pathological scores (<0.05). A major activity was observed in total testosterone, lutenizing hormone, testicular volumes and the logistic regression of pathological scores (<0.05).


Assuntos
Azoospermia , Azoospermia/epidemiologia , Grupos Controle , Feminino , Humanos , Masculino , Gravidez , Estudos Retrospectivos , Recuperação Espermática , Espermatozoides , Testículo
17.
J Clin Immunol ; 42(1): 10-18, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34694544

RESUMO

BACKGROUND: The present study aimed to compare serum total IgA levels between severe and mild COVID-19 patients' groups and the control group. METHODS: In this cross-sectional study, 216 definite severe COVID-19 patients (as the inpatient group), 183 subjects with positive specific COVID-19 IgG with mild or no symptoms as the (outpatient group), and 203 healthy subjects with negative specific serology, as the control group were investigated. The cases' laboratory data were collected, and thereafter, statistical tests, including independent samples t test, ANOVA test, and post hoc test, were performed using SPSS software version 22. RESULT: The mean ± SD of IgA in all the included subjects was 2.23 ± 0.78 (g/L). According to the obtained results, there were statistically significant changes in IgA among the three study groups (P value < 0.05). This difference was significant between both outpatient and inpatient groups (P value < 0.05). The mean ± SD of serum IgG in all the subjects was calculated as 15.83 ± 5.73 (g/L). A strong statistically significant change was also seen in IgG among all three groups (P value < 0.001). Of note, there was a significant negative correlation between IgG and IgA total titers of the outpatient group (P value = 0.011*r = - 0.188). CONCLUSION: It was shown that the total serum IgA and IgG levels are significantly associated with the severity of COVID-19 infection. As well, we found that total serum IgA and IgG are associated with the severity of illness. Since a low level of IgA is asymptomatic and high frequent in Iran and other countries, we suggest the evaluation of serum IgA levels in high-risk people and strengthening immune system in subjects with a low level of IgA, in order to reduce the rate of death. In this regard, oral or nasal mucosal vaccines in combination with parenteral vaccination are recommended due to increasing immunity versus COVID-19 by further secretion of the IgA antibody and preventing virus transmission.


Assuntos
COVID-19/sangue , Imunoglobulina A/sangue , Adulto , Anticorpos Antivirais/sangue , Grupos Controle , Estudos Transversais , Feminino , Humanos , Imunoglobulina G/sangue , Irã (Geográfico) , Masculino , Pessoa de Meia-Idade
18.
Psychol Health ; 37(2): 178-193, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34121544

RESUMO

ObjectiveThe COVID-19 pandemic has constituted an unprecedented challenge to society and science and it has provided an unexpected opportunity to explore the effects of a positive intervention in times of adversity and confinement. The goal was to evaluate the effects of a theory driven group intervention to cultivate mental health and flourishing. Design: A pre post design with three groups (151 individuals) was conducted, including an experimental group that received the intervention during the pandemic, a pre-COVID intervention group, and a COVID control group. Main Outcome Measures: Based on Keyes' concept of positive mental health, measures of subjective, psychological and social well-being were obtained, as well as an indicator of psychological distress (GHQ12). Results: Intervention groups showed an increase in well-being and the COVID control group a decrease. Change scores revealed significant differences. Overall percentage of individuals at risk of ill health in baseline was 25.2%, but after the intervention, the COVID control group reached 64.1%. Conclusions: Despite the limitations, the present findings suggest that interventions to sustain and improve mental health in times of crisis and adversity can be an effective approach.


Assuntos
COVID-19 , Grupos Controle , Humanos , Saúde Mental , Pandemias , Quarentena , SARS-CoV-2
19.
J Parkinsons Dis ; 12(1): 315-331, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34602501

RESUMO

BACKGROUND: Constipation has been linked to cognitive impairment development in Parkinson's disease (PD). OBJECTIVE: Our aim was to analyze cognitive changes observed in PD patients and controls from a Spanish cohort with regards to the presence or not of constipation. METHODS: PD patients and controls recruited from 35 centers of Spain from the COPPADIS cohort from January 2016 to November 2017 were followed-up during 2 years. The change in cognitive status from baseline (V0) to 2-year follow-up was assessed with the PD-CRS (Parkinson's Disease Cognitive Rating Scale). Subjects with a score ≥1 on item 21 of the NMSS (Non-Motor Symptoms Scale) at baseline (V0) were considered as "with constipation". Regression analyses were applied for determining the contribution of constipation in cognitive changes. RESULTS: At V0, 39.7% (198/499) of PD patients presented constipation compared to 11.4% of controls (14/123) (p < 0.0001). No change was observed in cognitive status (PD-CRS total score) neither in controls without constipation (from 100.24±13.72 to 100.27±13.68; p = 0.971) and with constipation (from 94.71±10.96 to 93.93±13.03; p = 0.615). The PD-CRS total score decreased significantly in PD patients with constipation (from 89.14±15.36 to 85.97±18.09; p < 0.0001; Coehn's effect = -0.35) compared to patients without constipation (from 93.92±15.58 to 93.14±17.52; p = 0.250) (p = 0.018). In PD patients, to suffer from constipation at V0 was associated with a decrease in the PD-CRS total score from V0 to V2 (ß= -0.1; 95% CI, -4.36 - -0.27; p = 0.026) and having cognitive impairment at V2 (OR = 1.79; 95% CI, 1.01 - 3.17; p = 0.045). CONCLUSION: Constipation is associated with cognitive decline in PD patients but not in controls.


Assuntos
Disfunção Cognitiva , Doença de Parkinson , Disfunção Cognitiva/complicações , Constipação Intestinal/complicações , Grupos Controle , Seguimentos , Humanos , Doença de Parkinson/complicações , Doença de Parkinson/psicologia
20.
Psychiatr Serv ; 73(4): 439-446, 2022 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-34346736

RESUMO

OBJECTIVE: Mental Health First Aid (MHFA) is a globally disseminated course that trains members of the public to recognize and respond to mental health issues in their communities. Although substantial evidence suggests that MHFA training is associated with positive changes in knowledge, attitudes, and behavioral intent, little is known about how MHFA trainee-delivered aid supports mental health needs. This systematic review sought to summarize the extant research evaluating MHFA trainees' helping behaviors and the impacts of these behaviors on people experiencing a mental health problem (i.e., recipients). METHODS: Electronic databases were searched for MHFA evaluations published before or on March 9, 2021. Studies that evaluated at least one outcome related to trainee helping behavior or recipient mental health were included in the synthesis. Outcomes were organized into three categories: trainee use of MHFA skills, helpfulness of trainees' actions, and recipients' mental health. Only studies that compared pre- and posttraining outcomes, included a control group, and directly evaluated MHFA were used to assess its efficacy. RESULTS: The search identified 31 studies, nine of which met criteria to assess MHFA efficacy. The findings of the nine studies indicated that MHFA had mixed effects on trainees using the skills taught in the course and no effects on the helpfulness of trainees' actions or on recipient mental health. CONCLUSIONS: The findings indicate that there is insufficient current evidence that MHFA improves the helping behaviors of trainees or the mental health of those receiving helping behaviors. They highlight a crucial research gap that should be prioritized as MHFA continues to grow in popularity.


Assuntos
Primeiros Socorros , Transtornos Mentais , Grupos Controle , Bases de Dados Factuais , Humanos , Transtornos Mentais/terapia , Saúde Mental , Avaliação de Resultados em Cuidados de Saúde
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