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1.
Age Ageing ; 52(1)2023 01 08.
Artigo em Inglês | MEDLINE | ID: mdl-36702513

RESUMO

BACKGROUND: people living with cognitive impairment commonly take multiple medications including potentially inappropriate medications (PIMs), which puts them at risk of medication related harms. AIMS: to explore willingness to have a medication deprescribed of older people living with cognitive impairment (dementia or mild cognitive impairment) and multiple chronic conditions and assess the relationship between willingness, patient characteristics and belief about medications. METHODS: cross-sectional study using results from the revised Patients' Attitudes Towards Deprescribing questionnaire (rPATDcog) collected as baseline data in the OPTIMIZE study, a pragmatic, cluster-randomised trial educating patients and clinicians about deprescribing. Eligible participants were 65+, diagnosed with dementia or mild cognitive impairment, and prescribed at least five-long-term medications. RESULTS: the questionnaire was mailed to 1,409 intervention patients and 553 (39%) were returned and included in analysis. Participants had a mean age of 80.1 (SD 7.4) and 52.4% were female. About 78.5% (431/549) of participants said that they would be willing to have one of their medications stopped if their doctor said it was possible. Willingness to deprescribe was negatively associated with getting stressed when changes are made and with previously having a bad experience with stopping a medication (P < 0.001 for both). CONCLUSION: most older people living with cognitive impairment are willing to deprescribe. Addressing previous bad experiences with stopping a medication and stress when changes are made to medications may be key points to discuss during deprescribing conversations.


Assuntos
Disfunção Cognitiva , Demência , Desprescrições , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Cuidadores/psicologia , Estudos Transversais , Disfunção Cognitiva/diagnóstico , Disfunção Cognitiva/tratamento farmacológico , Polimedicação , Demência/diagnóstico , Demência/tratamento farmacológico
2.
BMC Vet Res ; 18(1): 272, 2022 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-35831819

RESUMO

BACKGROUND: Visual evoked potentials (VEPs) can provide objective functional assessment of the post-retinal visual pathway. This study compared the effects of sedation (butorphanol and dexmedetomidine) and general anesthesia (propofol and sevoflurane) on pattern and flash VEPs. Dogs (n = 13) underwent sedation or anesthesia and VEPs were obtained from 3 subcutaneous recording electrodes placed on the head (O1, Oz, O2). RESULTS: Pattern VEPs could only be recorded under sedation and a maximum of 3 peaks were identified (N75, P100, N135). Flash VEPs could be recorded under both sedation and anesthesia and a maximum of 5 peaks were identified (N1, P1, N2, P2, N3). The latency of the N1 peak and the baseline-N1 amplitude were significantly longer under general anesthesia. CONCLUSION: Visual evoked potentials should be preferentially recorded in dogs sedated with dexmedetomidine and butorphanol, regardless of the stimulus.


Assuntos
Dexmedetomidina , Propofol , Anestesia Geral/veterinária , Animais , Butorfanol/farmacologia , Dexmedetomidina/farmacologia , Cães , Potenciais Evocados Visuais , Propofol/farmacologia
3.
J Intensive Care Med ; 36(8): 857-861, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32519573

RESUMO

OBJECTIVE: To subjectively identify low-risk ST-elevation myocardial infarction (STEMI) patients and triage this low-risk population to an intermediate level of care. BACKGROUND: Many patients with STEMI are admitted to the intensive care unit (ICU), however, a large portion do not merit ICU admission. We sought to examine whether, among post-STEMI patients admitted to the ICU, if an easily obtainable subjective scoring system could predict low-risk patients and safely triage them to an intermediate level of care. METHODS: Retrospective observational study at Christiana Hospital, a 900-bed regional referral center. Data were defined by the ACTION Registry and CathPCI Registry. Acute Physiology and Chronic Health Evaluation (APACHE) predictions were retrieved for all patients with STEMI and were analyzed for complications, length of stay, and inhospital mortality. We then examined subjective criteria to triage patients with STEMI out of the ICU. RESULTS: Among 253 patients with STEMI, 179 (70.75%) were classified as low risk (intermediate level care appropriate) and 74 (29.25%) were classified as high risk (ICU appropriate). The mean age was 64.95 years. The APACHE III score was right skewed with a mean of 36.97 and a median of 31. There was a significant difference between the APACHE III score of low-risk patients and the APACHE III score of high-risk patients (P < .001). CONCLUSION: In conclusion, patients characterized as low risk, as defined by our criteria, had low APACHE III scores and a low likelihood of complications post-STEMI. This low-risk population could potentially be admitted to an intermediate level of care, avoiding the ICU altogether.


Assuntos
Infarto do Miocárdio com Supradesnível do Segmento ST , APACHE , Idoso , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva , Tempo de Internação , Pessoa de Meia-Idade , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Triagem
4.
Can J Anaesth ; 68(11): 1668-1682, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34374024

RESUMO

BACKGROUND: Shock is common in critically ill and injured patients. Survival during shock is highly dependent on rapid restoration of tissue oxygenation with therapeutic goals based on cardiac output (CO) optimization. Despite the clinical availability of numerous minimally invasive monitors of CO, limited supporting performance data are available. METHODS: Following approval of the University of Saskatchewan Animal Research Ethics Board, we assessed the performance and trending ability of PiCCOplus™, FloTrac™, and CardioQ-ODM™ across a range of CO states in pigs. In addition, we assessed the ability of invasive mean arterial blood pressure (iMAP) to follow changes in CO using a periaortic transit-time flow probe as the reference method. Statistical analysis was performed with function-fail, bias and precision, percent error, and linear regression at all flow, low-flow (> 1 standard deviation [SD] below the mean), and high-flow (> 1 SD above the mean) CO conditions. RESULTS: We made a total of 116,957 paired CO measurements. The non-invasive CO monitors often failed to provide a CO value (CardioQ-ODM: 40.6% failed measurements; 99% confidence interval [CI], 38.5 to 42.6; FloTrac: 9.6% failed measurements; 99% CI, 8.7 to 10.5; PiCCOplus: 4.7% failed measurements; 99% CI, 4.5 to 4.9; all comparisons, P < 0.001). The invasive mean arterial pressure provided zero failures, failing less often than any of the tested CO monitors (all comparisons, P < 0.001). The PiCCOplus was most interchangeable with the flow probe at all flow states: PiCCOplus (20% error; 99% CI, 19 to 22), CardioQ-ODM (25% error; 99% CI, 23 to 27), FloTrac (34% error; 99% CI, 32 to 38) (all comparisons, P < 0.001). At low-flow states, CardioQ-ODM (43% error; 99% CI, 32 to 63) and Flotrac (45% error; 99% CI, 33 to 70) had similar interchangeability (P = 0.07), both superior to PiCCOplus (48% error; 99% CI, 42 to 60) (P < 0.001). Regarding CO trending, the CardioQ-ODM (correlation coefficient, 0.82; 99% CI, 0.81 to 0.83) was statistically superior to other monitors including iMAP, but at low flows iMAP (correlation coefficient, 0.58; 99% CI, 0.58 to 0.60) was superior to all minimally invasive CO monitors (all comparisons P < 0.001). CONCLUSIONS: None of the minimally invasive monitors of CO performed well at all tested flows. Invasive mean arterial blood pressure most closely tracked CO change at critical flow states.


RéSUMé: CONTEXTE: L'état de choc est fréquent chez les patients blessés et en urgence absolue. La survie pendant le choc dépend fortement de la restauration rapide de l'oxygénation tissulaire avec des objectifs thérapeutiques basés sur l'optimisation du débit cardiaque (DC). Malgré la disponibilité clinique de nombreux moniteurs minimalement invasifs du DC, il n'existe que des données limitées sur leur performance pour appuyer leur utilisation. MéTHODE: À la suite de l'approbation du comité d'éthique de la recherche animale de l'Université de la Saskatchewan, nous avons évalué la performance et la capacité de suivi des tendances des appareils PiCCOplus™, FloTrac™ et CardioQ-ODM™ sur une vaste gamme d'état de DC chez des cochons. Nous avons également évalué la capacité de la tension artérielle moyenne invasive (iMAP) à suivre les changements de DC en utilisant une sonde périaortique de débit basée sur le temps de transit comme méthode de référence. L'analyse statistique a été réalisée avec fonction-échec, biais et précision, pourcentage d'erreur et régression linéaire à des conditions de DC de tous les débits, de faible débit (> 1 écart-type [ET] au-dessous de la moyenne) et de débit élevé (> 1 ET au-dessus de la moyenne). RéSULTATS: Nous avons effectué un total de 116 957 mesures de DC appariées. Les moniteurs non invasifs de la DC n'ont souvent pas réussi à fournir une valeur de DC (CardioQ-ODM : 40,6% de mesures échouées; intervalle de confiance [IC] de 99 %, 38,5 à 42,6; FloTrac : 9,6 % de mesures échouées; IC 99 %, 8,7 à 10,5; PiCCOplus : 4,7 % de mesures échouées; IC 99 %, 4,5 à 4,9; toutes les comparaisons, P < 0,001). La tension artérielle moyenne invasive n'a fourni aucun échec plus souvent que n'importe lequel des moniteurs de DC testés (toutes les comparaisons, P < 0,001). Le PiCCOplus était le plus interchangeable avec la sonde de débit à tous les états de débit : PiCCOplus (erreur de 20 %; IC 99 %, 19 à 22), CardioQ-ODM (erreur de 25 %; IC 99 %, 23 à 27), FloTrac (erreur de 34 %; IC 99 %, 32 à 38) (toutes les comparaisons, P < 0,001). Aux états de débit faible, les moniteurs CardioQ-ODM (erreur de 43 %; IC 99 %, 32 à 63) et FloTrac (erreur de 45 %; IC 99 %, 33 à 70) présentaient une interchangeabilité similaire (P = 0,07), tous deux supérieurs au PiCCOplus (erreur de 48 %; IC 99 %, 42 à 60) (P < 0,001). En ce qui concerne le suivi des tendances de DC, le CardioQ-ODM (coefficient de corrélation, 0,82; IC 99 %, 0,81 à 0,83) était statistiquement supérieur aux autres moniteurs, y compris au iMAP, mais à faibles débits, l'iMAP (coefficient de corrélation, 0,58; IC 99 %, 0,58 à 0,60) était supérieure à tous les moniteurs de DC minimalement invasifs (toutes les comparaisons, P < 0,001). CONCLUSION: Aucun des moniteurs de DC minimalement invasif n'a donné de bons résultats à tous les débits testés. La tension artérielle moyenne invasive était le moniteur qui a suivi de plus près les changements de DC dans des états critiques de débit.


Assuntos
Termodiluição , Animais , Débito Cardíaco , Humanos , Modelos Lineares , Monitorização Fisiológica , Reprodutibilidade dos Testes , Suínos
5.
Acta Neurochir (Wien) ; 163(4): 947-951, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33479812

RESUMO

Ipsilateral corticospinal innervation is rare. No prior cases have described ipsilateral tumor-associated symptoms as the presentation of an uncrossed corticospinal tract. Herein, we describe a case associated with a left frontal tumor, presenting with transient ipsilateral hemiparesis and aphasia. Due to the fluctuating symptomatology, we suspected a cerebrovascular cause and initially performed a workup for stroke. Ipsilateral motor innervation was discovered with intraoperative monitoring during the resection of the tumor, and confirmed with postoperative diffusion tensor imaging (DTI). Neurosurgeons should be aware of uncrossed motor system, and include it in the differential of ipsilateral deficit in patients with intracranial tumors.


Assuntos
Neoplasias Encefálicas/cirurgia , Monitorização Neurofisiológica Intraoperatória/métodos , Paresia/cirurgia , Tratos Piramidais/patologia , Imagem de Tensor de Difusão/métodos , Humanos , Tratos Piramidais/diagnóstico por imagem , Tratos Piramidais/fisiopatologia
6.
J Stroke Cerebrovasc Dis ; 30(3): 105593, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33434816

RESUMO

OBJECTIVES: We report a 61-year-old woman who developed left hemiparesis following a right frontal stroke. She underwent rehabilitation and regained function of the left side of her body. Three years after her first stroke, she developed a large left subdural hematoma and again presented with left hemiparesis. MATERIALS AND METHODS: Prior to the cranioplasty, an fMRI scan involving left and right hand movement, arm movement, and foot peddling were conducted in order to determine whether the patient showed ipsilateral activation for the motor tasks, thus explaining the left hemiparesis following the left subdural hematoma. Diffusion tensor imaging (DTI) tractography was also collected to visualize the motor and sensory tracts. RESULTS: The fMRI results revealed activation in the expected contralateral left primary motor cortex (M1) for the right-sided motor tasks, and bilateral M1 activation for the left-sided motor tasks. Intraoperative neurophysiology confirmed these findings, whereby electromyography revealed left-sided (i.e., ipsilateral) responses for four of the five electrode locations. The DTI results indicated that the corticospinal tracts and spinothalamic tracts were within normal limits and showed no displacement or disorganization. CONCLUSIONS: These results suggest that there may have been reorganization of the M1 following her initial stroke, and that the left hemisphere may have become involved in moving the left side of the body thereby leading to left hemiparesis following the left subdural hematoma. The findings suggest that cortical reorganization may occur in stroke patients recovering from hemiparesis, and specifically, that components of motor processing subserved by M1 may be taken over by ipsilateral regions.


Assuntos
Mapeamento Encefálico , Hematoma Subdural/diagnóstico por imagem , Acidente Vascular Cerebral Hemorrágico/diagnóstico por imagem , Imageamento por Ressonância Magnética , Córtex Motor/diagnóstico por imagem , Destreza Motora , Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral/terapia , Adaptação Fisiológica , Craniectomia Descompressiva , Imagem de Tensor de Difusão , Feminino , Hematoma Subdural/fisiopatologia , Hematoma Subdural/cirurgia , Acidente Vascular Cerebral Hemorrágico/fisiopatologia , Acidente Vascular Cerebral Hemorrágico/cirurgia , Humanos , Pessoa de Meia-Idade , Córtex Motor/fisiopatologia , Valor Preditivo dos Testes , Recuperação de Função Fisiológica , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/fisiopatologia , Resultado do Tratamento
7.
J Gen Intern Med ; 35(12): 3556-3563, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32728959

RESUMO

BACKGROUND: Patients with dementia and multiple chronic conditions (MCC) frequently experience polypharmacy, increasing their risk of adverse drug events. OBJECTIVES: To elucidate patient, family, and physician perspectives on medication discontinuation and recommended language for deprescribing discussions in order to inform an intervention to increase awareness of deprescribing among individuals with dementia and MCC, family caregivers and primary care physicians. We also explored participant views on culturally competent approaches to deprescribing. DESIGN: Qualitative approach based on semi-structured interviews with patients, caregivers, and physicians. PARTICIPANTS: Patients aged ≥ 65 years with claims-based diagnosis of dementia, ≥ 1 additional chronic condition, and ≥ 5 chronic medications were recruited from an integrated delivery system in Colorado and an academic medical center in Maryland. We included caregivers when present or if patients were unable to participate due to severe cognitive impairment. Physicians were recruited within the same systems and through snowball sampling, targeting areas with large African American and Hispanic populations. APPROACH: We used constant comparison to identify and compare themes between patients, caregivers, and physicians. KEY RESULTS: We conducted interviews with 17 patients, 16 caregivers, and 16 physicians. All groups said it was important to earn trust before deprescribing, frame deprescribing as routine and positive, align deprescribing with goals of dementia care, and respect caregivers' expertise. As in other areas of medicine, racial, ethnic, and language concordance was important to patients and caregivers from minority cultural backgrounds. Participants favored direct-to-patient educational materials, support from pharmacists and other team members, and close follow-up during deprescribing. Patients and caregivers favored language that explained deprescribing in terms of altered physiology with aging. Physicians desired communication tips addressing specific clinical situations. CONCLUSIONS: Culturally sensitive communication within a trusted patient-physician relationship supplemented by pharmacists, and language tailored to specific clinical situations may support deprescribing in primary care for patients with dementia and MCC.


Assuntos
Demência , Desprescrições , Idoso , Cuidadores , Colorado , Demência/tratamento farmacológico , Humanos , Maryland , Atenção Primária à Saúde
8.
J Clin Monit Comput ; 33(2): 191-192, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30778916

RESUMO

The article Is the new ASNM intraoperative neuromonitoring supervision "guideline" a trustworthy guideline? A commentary, written by Stanley A. Skinner, Elif Ilgaz Aydinlar, Lawrence F. Borges, Bob S. Carter, Bradford L. Currier, Vedran Deletis, Charles Dong, John Paul Dormans, Gea Drost, Isabel Fernandez­Conejero, E. Matthew Hoffman, Robert N. Holdefer, Paulo Andre Teixeira Kimaid, Antoun Koht, Karl F. Kothbauer, David B. MacDonald, John J. McAuliffe III, David E. Morledge, Susan H. Morris, Jonathan Norton, Klaus Novak, Kyung Seok Park, Joseph H. Perra, Julian Prell, David M. Rippe, Francesco Sala, Daniel M. Schwartz, Martín J. Segura, Kathleen Seidel, Christoph Seubert, Mirela V. Simon, Francisco Soto, Jeffrey A. Strommen, Andrea Szelenyi, Armando Tello, Sedat Ulkatan, Javier Urriza and Marshall Wilkinson, was originally published electronically on the publisher's internet portal (currently SpringerLink) on 05 January 2019 without open access. With the author(s)' decision to opt for Open Choice the copyright of the article changed on 30 January 2019 to © The Author(s) 2019 and the article is forthwith distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits use, duplication, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made. The original article has been corrected.

12.
J Clin Monit Comput ; 35(5): 957-958, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33459946
13.
Can J Surg ; 58(3): 206-8, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25799133

RESUMO

Intraoperative neuromonitoring is a specialized skill set performed in the operating room to reduce the risk of neurologic injury. There appears to be a shortage of qualified personnel and a lack of Canadian guidelines on the performance of the task. We distributed a web-based survey on the attitude of the surgeons to the interpretation of intraoperative neuromonitoring data among surgeons who use the technique. At present, most of the interpretation is performed by either technologists or by the surgeons themselves. Most surgeons would prefer professional oversight from a neurologist or neurophysiologist at the doctoral level. There is a lack of personnel in Canada with the appropriate training and expertise to interpret intraoperative neuromonitoring data.


Assuntos
Atitude do Pessoal de Saúde , Técnicas de Diagnóstico Neurológico , Monitorização Intraoperatória/métodos , Cirurgiões , Canadá , Coleta de Dados , Humanos , Neurologia , Neurofisiologia , Padrões de Prática Médica , Recursos Humanos
14.
Folia Phoniatr Logop ; 67(4): 202-11, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26771452

RESUMO

OBJECTIVE: To develop a standardized paediatric protocol for acquiring simultaneous chest wall kinematics and surface electromyography (EMG) of chest wall muscles during maximum performance and speech tasks. PATIENTS AND METHODS: Eighteen healthy participants included: (a) a younger age group (n = 6; ages 4.0-6.5 years), (b) an older age group (n = 6; ages 7.0-10.5 years), and (c) an adult group (n = 8; ages 21-33 years). A child (age 10 years) with spastic-type cerebral palsy (CP) served as a 'proof of protocol feasibility'. Chest wall kinematics and surface EMGs (intercostals, rectus abdominus, external oblique, latissimus dorsi, and erector spinae) were acquired during maximum performance and speech tasks. RESULTS: Successful calibration of the EMG signal and reliable detection of muscle activation onset, offset, and amplitude relative to vital capacity and percent maximum voluntary contraction in children were demonstrated. Kinematic and surface EMG measurements were sensitive to non-speech and speech tasks, age, and neurological status (i.e. CP). CONCLUSION: The simultaneous measurement of kinematics and EMG of the chest wall muscle groups provides a more comprehensive description of speech breathing in children. This protocol can be used for the observation and interpretation of clinical outcomes seen in children with motor speech disorders following treatments that focus on increasing overall respiratory and vocal effort.


Assuntos
Fenômenos Biomecânicos , Eletromiografia , Contração Muscular/fisiologia , Respiração , Fala/fisiologia , Parede Torácica/fisiologia , Adulto , Paralisia Cerebral/fisiopatologia , Criança , Pré-Escolar , Estudos de Viabilidade , Feminino , Humanos , Masculino , Fonação/fisiologia , Capacidade Vital/fisiologia , Adulto Jovem
18.
Am Heart J Plus ; 40: 100375, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38586434

RESUMO

Obesity significantly increases the risk of developing atrial fibrillation (AF) and atrial flutter (AFL) and evidence from randomized trials indicates that weight loss may reduce the burden of AF/AFL in obese patients; however, the relationship between obesity and healthcare resource utilization in AF/AFL patients is lacking. We sought to assess this relationship in patients with newly diagnosed AF/AFL in a nationally representative cohort of the United States by using the MarketScan® claims database. International Classification of Diseases, Tenth Revision [ICD 10] diagnosis codes were used to select individuals with a new diagnosis of AF/AFL in 2017 and 2018, adjudicate baseline variables and to classify them according to obesity status. Patients were followed for two years at which point all data was censored. The primary outcome of the study was hospitalizations due to AF/AFL. Cox proportional hazards regression models were used to assess the adjusted hazard ratio for obese versus non-obese patients. There were 55,271 patients with new onset AF/AFL, which included 43,314 (78.4 %) who were non-obese and 11,957 (21.6 %) who were obese. There were significantly more males than females among non-obese (65.3 % vs. 34.7 %) and obese individuals (62.3 % vs. 37.7 %). The average age (SD) was similar in the non-obese (54.5 (9.7)) and obese cohorts (54.7 (8.4)), respectively. The incidence of Emergency Department visits (4.0 % vs. 6.5 %), hospitalizations (5.5 % vs. 10.7 %), cardioversions (6.6 % vs. 12.7 %), and ablation procedures (5.3 % vs. 8.6 %) were significantly increased among obese patients.

19.
Drugs Aging ; 41(1): 45-54, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37982982

RESUMO

BACKGROUND: Patients, family members, and clinicians express concerns about potential adverse drug withdrawal events (ADWEs) following medication discontinuation or fears of upsetting a stable medical equilibrium as key barriers to deprescribing. Currently, there are limited methods to pragmatically assess the safety of deprescribing and ascertain ADWEs. We report the methods and results of safety monitoring for the OPTIMIZE trial of deprescribing education for patients, family members, and clinicians. METHODS: This was a pragmatic cluster randomized trial with multivariable Poisson regression comparing outcome rates between study arms. We conducted clinical record review and adjudication of sampled records to assess potential causal relationships between medication discontinuation and outcomes. This study included adults aged 65+ with dementia or mild cognitive impairment, one or more additional chronic conditions, and prescribed 5+ chronic medications. The intervention included an educational brochure on deprescribing that was mailed to patients prior to primary care visits, a clinician notification about individual brochure mailings, and an educational tip sheets was provided monthly to primary care clinicians. The outcomes of the safety monitoring were rates of hospitalizations and mortality during the 4 months following brochure mailings and results of record review and adjudication. The adjudication process was conducted throughout the trial and included classifications: likely, possibly, and unlikely. RESULTS: There was a total of 3012 (1433 intervention and 1579 control) participants. There were 420 total hospitalizations involving 269 (18.8%) people in the intervention versus 517 total hospitalizations involving 317 (20.1%) people in the control groups. Adjusted risk ratios comparing intervention to control groups were 0.92 [95% confidence interval (CI) 0.72, 1.16] for hospitalization and 1.19 (95% CI 0.67, 2.11) for mortality. Both groups had zero deaths "likely" attributed to a medication change prior to the event. A total of 3 out of 30 (10%) intervention group hospitalizations and 7 out of 35 (20%) control group hospitalizations were considered "likely" due to a medication change. CONCLUSIONS: Population-based deprescribing education is safe in the older adult population with cognitive impairment in our study. Pragmatic methods for safety monitoring are needed to further inform deprescribing interventions. TRIAL REGISTRATION: NCT03984396. Registered on 13 June 2019.


Assuntos
Desprescrições , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Idoso , Humanos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Hospitalização
20.
Ther Innov Regul Sci ; 57(5): 911-939, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37244885

RESUMO

While the ICH E9(R1) Addendum on "Estimands and Sensitivity Analysis in Clinical Trials" was released in late 2019, the widespread implementation of defining and reporting estimands across clinical trials is still in progress and the engagement of non-statistical functions in this process is also in progress. Case studies are sought after, especially those with documented clinical and regulatory feedback. This paper describes an interdisciplinary process for implementing the estimand framework, devised by the Estimands and Missing Data Working Group (a group with clinical, statistical, and regulatory representation) of the International Society for CNS Clinical Trials and Methodology. This process is illustrated by specific examples using various types of hypothetical trials evaluating a treatment for major depressive disorder. Each of the estimand examples follows the same template and features all steps of the proposed process, including identifying the trial stakeholder(s), the decisions they need to make about the investigated treatment in their specific role and the questions that would support their decision making. Each of the five strategies for handling intercurrent events are addressed in at least one example; the featured endpoints are also diverse, including continuous, binary and time to event. Several examples are presented that include specifications for a potential trial design, key trial implementation elements needed to address the estimand, and main and sensitivity estimator specifications. Ultimately this paper highlights the need to incorporate multi-disciplinary collaborations into implementing the ICH E9(R1) framework.


Assuntos
Transtorno Depressivo Maior , Modelos Estatísticos , Humanos , Projetos de Pesquisa , Transtorno Depressivo Maior/tratamento farmacológico , Interpretação Estatística de Dados
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