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1.
BMJ Open ; 11(9): e050104, 2021 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-34475177

RESUMO

BACKGROUND: An understanding and appreciation of scientific research is a key quality of the modern clinician. Yet the Medical Schools Council has previously reported a reduction in the number of clinicians performing research. To explore the reasons for this difficulty, this multicentre, cross-sectional study aims to determine the medical student involvement and perceptions of research and research-orientated careers. It will additionally identify perceived barriers and incentives to participating in research as a student. METHODS AND ANALYSIS: This cross-sectional study of medical students at UK medical schools recognised by the General Medical Council will be administered using an online questionnaire. This will be disseminated nationally over a 2-month period through collaborative university medical school and student networks. The primary outcome is to determine the extent to which medical students are currently involved in research. Secondary outcomes include identifying the personal and demographic factors involved in incentivising and deterring medical students from becoming involved in research during medical school. This will be achieved using a selection of Likert scale, multiple-choice and free text questions. Ordinal logistic regression analysis will be performed to understand the association between specific factors and student involvement in research. This study will also characterise the proportion of medical students who are currently interested in conducting research in the future. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Medical Sciences Interdivisional Research Ethics Committee, Oxford, England. The results will be disseminated via publication in a peer-reviewed medical journal and may be presented at local, regional, national and international conferences by medical student collaborators.


Assuntos
Estudantes de Medicina , Atitude , Estudos Transversais , Humanos , Estudos Multicêntricos como Assunto , Faculdades de Medicina , Reino Unido
2.
BMJ Open ; 11(9): e050833, 2021 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-34475182

RESUMO

INTRODUCTION: Diabetic foot disease is a common condition globally and is over-represented in indigenous populations. The propensity for patients with diabetic foot disease to undergo minor or major limb amputation is a concern. Diabetic foot disease and lower limb amputation are debilitating for patients and have a substantial financial impact on health services. The purpose of this multicentre study is to prospectively report the presentation, management and outcomes of diabetic foot disease, to validate existing scoring systems and assess long term outcomes for these patients particularly in relation to major limb amputation. METHODS AND ANALYSIS: This is a multisite, international, prospective observational study, being undertaken at Waikato Hospital, New Zealand (NZ); Sir Charles Gairdner Hospital, the Royal Adelaide Hospital and the Queen Elizabeth Hospital, Australia. Consecutive participants with diabetic foot disease that meet inclusion criteria and agree to participate will be recruited from multidisciplinary team diabetic foot clinic, vascular clinic, dialysis and admission to hospital. Follow-up of participants will occur at 1, 3, 6 and 12 months. At recruitment and follow-up reviews, information about service details, demographic and clinical history, wound data and discharge information will be recorded. The primary outcomes are the time to wound healing, major amputation, overall mortality and amputation-free survival at 12 months. This study started in NZ in August 2020 and will commence in Australian sites in early 2021. ETHICS AND DISSEMINATION: New Zealand Central Health and Disability Ethics Committee (20/CEN/122), Waikato DHB Research Department (RDO020044), Quality Improvement HoD Sir Charles Gairdner Hospital (39715) and the Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (13928). Results will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12621000337875).


Assuntos
Diabetes Mellitus , Pé Diabético , Austrália/epidemiologia , Pé Diabético/epidemiologia , Pé Diabético/cirurgia , Humanos , Estudos Multicêntricos como Assunto , Nova Zelândia/epidemiologia , Estudos Observacionais como Assunto , Diálise Renal , Temefós
3.
BMJ Open ; 11(9): e045541, 2021 09 03.
Artigo em Inglês | MEDLINE | ID: mdl-34479930

RESUMO

INTRODUCTION: Between 5% and 30% of abdominal incisions eventually result in incisional hernias (IHs) that can lead to severe complications and impaired quality of life. Unfortunately, IH repair is often unsuccessful; therefore, hernia prophylaxis is an important issue. The efficacy of mesh augmentation has been proven for hernia prophylaxis in high-risk patients, but no randomised clinical trial has evaluated prophylactic mesh placement in emergency/urgent gastrointestinal operations. METHODS AND ANALYSIS: A multicentre, prospective randomised, open and patient-assessor blinded endpoint design will be conducted. A total of 470 patients will be enrolled and randomly allocated to retrorectus mesh augmentation with lightweight polypropylene mesh or primary suture closure. The primary outcome is IH occurrence within 24 months of follow-up, while other clinical outcomes are secondary endpoints. A cost-effectiveness analysis will be conducted from the societal and provider perspectives. ETHICS AND DISSEMINATION: Ethics approval was obtained from Ramathibodi Hospital (MURA2020/1478) and Vajira Hospital (COA164/2563). The protocol is on the process of submission to the local ethics committee of the other study sites. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: TCTR20200924002.


Assuntos
Hérnia Incisional , Trato Gastrointestinal , Humanos , Hérnia Incisional/prevenção & controle , Estudos Multicêntricos como Assunto , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Telas Cirúrgicas/efeitos adversos
4.
BMJ Open ; 11(9): e051003, 2021 09 03.
Artigo em Inglês | MEDLINE | ID: mdl-34479938

RESUMO

INTRODUCTION: Acute traumatic coagulopathy (ATC) in bleeding trauma patients increase in-hospital mortality. Fibrinogen concentrate (FC) and prothrombin complex concentrate (PCC) are two purified concentrates of clotting factors that have been used to treat ATC. However, there is a knowledge gap on their use compared with the standard of care, the transfusion of plasma. METHODS AND ANALYSIS: The factors in the initial resuscitation of severe trauma 2 trial is a multicentre, randomised, parallel-control, single-blinded, phase IV superiority trial. The study aims to address efficacy and safety of the early use of FC and PCC compared with a plasma-based resuscitation. Adult trauma patients requiring massive haemorrhage protocol activation on hospital arrival will receive FC 4 g and PCC 2000 IU or plasma 4 U, based on random allocation. The primary outcome is a composite of the cumulative number of all units of red cells, plasma and platelets transfused within 24 hours following admission. Secondary outcomes include measures of efficacy and safety of the intervention. Enrolment of 350 patients will provide an initial power >80% to demonstrate superiority for the primary outcome. After enrolment of 120 patients, a preplanned adaptive interim analysis will be conducted to reassess assumptions, check for early superiority demonstration or reassess the sample size for remainder of the study. ETHICS AND DISSEMINATION: The study has been approved by local and provincial research ethics boards and will be conducted according to the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. As per the Tri-Council Policy Statement, patient consent will be deferred due to the emergency nature of the interventions. If superiority is established, results will have a major impact on clinical practice by reducing exposure to non-virally inactivated blood products, shortening the time for administration of clotting factors, correct coagulopathy more efficaciously and reduce the reliance on AB plasma. TRIAL REGISTRATION NUMBER: NCT04534751, pre results.


Assuntos
Transtornos da Coagulação Sanguínea , Hemostáticos , Transtornos da Coagulação Sanguínea/tratamento farmacológico , Transfusão de Sangue , Fibrinogênio , Hemorragia/tratamento farmacológico , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
5.
BMJ Open ; 11(9): e045854, 2021 09 06.
Artigo em Inglês | MEDLINE | ID: mdl-34489267

RESUMO

INTRODUCTION: Multiple myeloma (MM) is a plasma cell cancer where about 1/3 of the patients present with pathological fractures at the time of diagnosis. Despite treatment, the majority of the patients will develop additional fractures. Because survival and prognosis has improved significantly over the last two decades for patients with MM, there is an increased need to focus on optimal fracture treatment. Traditionally, fracture pain is treated conservatively with opioids, bisphosphonates, bracing and radiation therapy. Vertebral augmentation has been used for the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for the efficacy is weak. We describe a trial assessing the impact of vertebroplasty on clinical outcome in the treatment of patients with MM with painful vertebral fractures. METHODS: 100 patients with MM with painful vertebral fractures will be randomised in a prospective, single-blinded, multicentre, clinical trial where patients are randomised to either usual care or usual care supplemented with vertebroplasty with a possibility of crossover 4 weeks after randomisation. The primary outcome will be change in Oswestry Disability Index at 4 weeks. ANALYSIS: Primary and secondary outcomes are assessed at baseline and at 4, 8, 26 and 52 weeks. Categorical data will be presented by means of frequencies and related percentages; continuous data will be displayed by means of descriptive statistics. ETHICS AND DISSEMINATION: The study has been evaluated by the Regional Committees on Health Research for Southern Denmark (S-20200075) and notified and approved by the Region of Southern Denmark and listed in the internal record, journal no. 20/22355. All participants provide consent. The protocol will follow the SPIRIT (Standard Protocol Items for Randomized Trials) statement. The Danish Myeloma Patient Organization supports the study. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04533217.


Assuntos
Fraturas por Compressão , Mieloma Múltiplo , Fraturas da Coluna Vertebral , Vertebroplastia , Fraturas por Compressão/etiologia , Fraturas por Compressão/cirurgia , Humanos , Estudos Multicêntricos como Assunto , Mieloma Múltiplo/complicações , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Fraturas da Coluna Vertebral/cirurgia , Resultado do Tratamento
6.
BMJ Open ; 11(9): e050259, 2021 09 06.
Artigo em Inglês | MEDLINE | ID: mdl-34489288

RESUMO

BACKGROUND: Substance use disorder (SUD) is a leading contributor to the global burden of disease. In Indonesia, the availability of formal treatment for SUD falls short of the targeted coverage. A standardised therapeutic option for SUD with potential for widespread implementation is required, yet evidence-based data in the country are scarce. In this study, we developed a cognitive behavioural therapy (CBT)-based group telemedicine model and will investigate effectiveness and implementability in a multicentre randomised controlled trial. METHODS: A total of 220 participants will be recruited from the social networks of eight sites in Indonesia: three hospitals, two primary healthcare centres and three rehabilitation centres. The intervention arm will participate in a relapse prevention programme called the Indonesia Drug Addiction Relapse Prevention Programme (Indo-DARPP), a newly developed 12-week module based on CBT and motivational interviewing constructed in the Indonesian context. The programme will be delivered by a healthcare provider and a peer counsellor in a group therapy setting via video-conferencing, as a supplement to participants' usual treatments. The control arm will continue treatment as usual. The primary outcome will be the percentage increase in days of abstinence from the primarily used substance in the past 28 days. Secondary outcomes will include addiction severity, quality of life, motivation to change, psychiatric symptoms, cognitive function, coping, and internalised stigma. Assessments will be performed at baseline (week 0), post-treatment (week 13), and 3 and 12 months post-treatment completion (weeks 24 and 60). Retention, participant satisfaction, and cost-effectiveness will be assessed as the implementation outcomes. ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Ethics Committees of Universitas Indonesia and Kyoto University. The results will be disseminated via academic journals and international conferences. Depending on trial outcomes, the treatment programme will be advocated for adoption as a formal healthcare-based approach for SUD. TRIAL REGISTRATION NUMBER: UMIN000042186.


Assuntos
Psicoterapia de Grupo , Transtornos Relacionados ao Uso de Substâncias , Análise Custo-Benefício , Humanos , Indonésia , Estudos Multicêntricos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Prevenção Secundária , Transtornos Relacionados ao Uso de Substâncias/prevenção & controle
7.
Trials ; 22(1): 607, 2021 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-34496941

RESUMO

BACKGROUND: Cervical radiculopathy is the most common disease in the cervical spine, affecting patients around 50-55 year of age. An operative treatment is common clinical praxis when non-operative treatment fails. The controversy is in the choice of operative treatment, conducting either anterior cervical decompression and fusion or posterior foraminotomy. The study objective is to evaluate short- and long-term outcome of anterior cervical decompression and fusion (ACDF) and posterior foraminotomy (PF) METHODS: A multicenter prospective randomized controlled trial with 1:1 randomization, ACDF vs. PF including 110 patients. The primary aim is to evaluate if PF is non-inferior to ACDF using a non-inferiority design with ACDF as "active control." The neck disability index (NDI) is the primary outcome measure, and duration of follow-up is 2 years. DISCUSSION: Due to absence of high level of evidence, the authors believe that a RCT will improve the evidence for using the different surgical treatments for cervical radiculopathy and strengthen current surgical treatment recommendation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04177849. Registered on November 26, 2019.


Assuntos
Foraminotomia , Radiculopatia , Fusão Vertebral , Vértebras Cervicais/diagnóstico por imagem , Vértebras Cervicais/cirurgia , Descompressão , Discotomia , Foraminotomia/efeitos adversos , Humanos , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Radiculopatia/diagnóstico , Radiculopatia/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fusão Vertebral/efeitos adversos , Resultado do Tratamento
8.
Trials ; 22(1): 582, 2021 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-34470656

RESUMO

BACKGROUND: Nut consumption has been related to improvements on cardiometabolic parameters and reduction in the severity of atherosclerosis mainly in primary cardiovascular prevention. The objective of this trial is to evaluate the effects of the Brazilian Cardioprotective Diet (DIeta CArdioprotetora Brasileira, DICA Br) based on consumption of inexpensive locally accessible foods supplemented or not with mixed nuts on cardiometabolic features in patients with previous myocardial infarction (MI). METHODS: DICA-NUTS study is a national, multicenter, randomized 16-week follow-up clinical trial. Patients over 40 years old with diagnosis of previous MI in the last 2 to 6 months will be recruited (n = 388). A standardized questionnaire will be applied to data collection and blood samples will be obtained. Patients will be allocated in two groups: Group 1: DICA Br supplemented with 30 g/day of mixed nuts (10 g of peanuts, 10 g of cashew, 10 g of Brazil nuts); and Group 2: only DICA Br. The primary outcome will consist of LDL cholesterol means (in mg/dL) after 16 weeks of intervention. Secondary outcomes will consist of other markers of lipid profile, glycemic profile, and anthropometric data. DISCUSSION: It is expected that DICA Br supplemented with mixed nuts have superior beneficial effects on cardiometabolic parameters in patients after a MI, when compared to DICA Br. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03728127 . First register: November 1, 2018; Last update: June 16, 2021. World Health Organization Universal Trial Number (WHO-UTN): U1111-1259-8105.


Assuntos
Dieta , Infarto do Miocárdio , Adulto , Biomarcadores , Glicemia , LDL-Colesterol , Humanos , Estudos Multicêntricos como Assunto , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto
9.
Trials ; 22(1): 585, 2021 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-34479619

RESUMO

BACKGROUND: Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials. METHODS: This clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, phase III trial of Anyu Peibo Capsule in China. The aim is to test whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcomes in adults (aged 18 to 65 years) with MDD. Patients will receive an 8-week treatment of Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change from baseline in the total score for the Montgomery-Asberg Depression Rating Scale at the end of the 8-week treatment. DISCUSSION: The trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. TRIAL REGISTRATION: ClinicalTrials.gov NCT04210973 . Registered on December 26, 2019.


Assuntos
Transtorno Depressivo Maior , Adulto , China , Transtorno Depressivo Maior/diagnóstico , Transtorno Depressivo Maior/tratamento farmacológico , Método Duplo-Cego , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
10.
Trials ; 22(1): 590, 2021 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-34488841

RESUMO

BACKGROUND: There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first level of care in the health system, are in a favorable position to carry out clinical trials (CD), as they work with a large volume of patients with varied profiles (from acute to chronic pathologies). During the COVID-19 pandemic, the need for hospital admission and mortality is higher in people > 60 years. Therefore, this is a target population to try to reduce the serious complications and lethality of COVID pneumonia and to avoid overloading the hospital system. Given the pharmacological properties of colchicine (anti-inflammatory and anti-fibrotic, possible inhibition of viral replication, and inhibitory effect on coagulation activation), early treatment with colchicine may reduce the rate of death and serious pulmonary complications from COVID-19 in vulnerable patients. METHODS: The COLCHICOVID study is a randomized, multicenter, controlled, open-label parallel group (2:1 ratio), phase III clinical trial to investigate the efficacy of early administration of colchicine in reducing the development of severe pulmonary complications associated with COVID-19 infection in patients over 60 years of age with at-risk comorbidities. DISCUSSION: This is a pragmatic clinical trial, adapted to usual clinical practice. The demonstration that early administration of colchicine has clinical effectiveness in reducing the complications of SARS-CoV-2 infection in a population highly susceptible may mitigate the health crisis and prevent the collapse of the health system in the successive waves of the coronavirus pandemic. In addition, colchicine is a well-known medicine, simple to use in the primary care setting and with a low cost for the health system. TRIAL REGISTRATION: ClinicalTrials.gov NCT04416334 . Registered on 4 June 2020. Protocol version: v 3.0, dated 22 September 2020.


Assuntos
COVID-19 , SARS-CoV-2 , Idoso , Colchicina/efeitos adversos , Humanos , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Pandemias , Atenção Primária à Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
11.
Trials ; 22(1): 595, 2021 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-34488845

RESUMO

BACKGROUND: Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety, and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. METHODS: A multicenter, randomized double-blind, placebo-controlled trial has been designed. Ninety eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: control group (n = 30), low-cell dose treatment group (n = 30), and high-cell dose treatment group (n = 30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. DISCUSSION: Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. TRIAL REGISTRATION: ClinicalTrials.gov NCT04466007 . Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.


Assuntos
COVID-19 , Diabetes Mellitus Tipo 2 , Transplante de Células-Tronco Hematopoéticas , Células-Tronco Mesenquimais , Noma , Tecido Adiposo , Animais , Ensaios Clínicos Fase II como Assunto , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Método Duplo-Cego , Humanos , Isquemia/diagnóstico , Isquemia/terapia , Estudos Multicêntricos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do Tratamento
12.
Trials ; 22(1): 591, 2021 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-34488858

RESUMO

OBJECTIVES: The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. TRIAL DESIGN: This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. PARTICIPANTS: Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). INTERVENTION AND COMPARATOR: The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 µg/kg/48 h (Arm A) or subcutaneous IVM at 200 µg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). MAIN OUTCOMES: Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). RANDOMISATION: A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. BLINDING (MASKING): Patients, primary care physicians, outcome assessors and the data collection team will be blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 180 participants will be randomized into six arms with five investigational and one placebo group. TRIAL STATUS: Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. TRIAL REGISTRATION: Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.


Assuntos
COVID-19 , Ivermectina , Feminino , Humanos , Ivermectina/efeitos adversos , Estudos Multicêntricos como Assunto , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do Tratamento , Zinco/efeitos adversos
13.
BMC Pediatr ; 21(1): 404, 2021 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-34521358

RESUMO

BACKGROUND: Relatively little is known about protective factors and the emergence and maintenance of positive outcomes in the field of adolescents with chronic conditions. Therefore, the primary aim of the study is to acquire a deeper understanding of the dynamic process of resilience factors, coping strategies and psychosocial adjustment of adolescents living with chronic conditions. METHODS/DESIGN: We plan to consecutively recruit N = 450 adolescents (12-21 years) from three German patient registries for chronic conditions (type 1 diabetes, cystic fibrosis, or juvenile idiopathic arthritis). Based on screening for anxiety and depression, adolescents are assigned to two parallel groups - "inconspicuous" (PHQ-9 and GAD-7 < 7) vs. "conspicuous" (PHQ-9 or GAD-7 ≥ 7) - participating in a prospective online survey at baseline and 12-month follow-up. At two time points (T1, T2), we assess (1) intra- and interpersonal resiliency factors, (2) coping strategies, and (3) health-related quality of life, well-being, satisfaction with life, anxiety and depression. Using a cross-lagged panel design, we will examine the bidirectional longitudinal relations between resiliency factors and coping strategies, psychological adaptation, and psychosocial adjustment. To monitor Covid-19 pandemic effects, participants are also invited to take part in an intermediate online survey. DISCUSSION: The study will provide a deeper understanding of adaptive, potentially modifiable processes and will therefore help to develop novel, tailored interventions supporting a positive adaptation in youths with a chronic condition. These strategies should not only support those at risk but also promote the maintenance of a successful adaptation. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), no. DRKS00025125 . Registered on May 17, 2021.


Assuntos
COVID-19 , Qualidade de Vida , Adaptação Psicológica , Adolescente , Depressão/epidemiologia , Humanos , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Pandemias , Estudos Prospectivos , SARS-CoV-2
14.
BMJ Open ; 11(9): e049376, 2021 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-34521667

RESUMO

INTRODUCTION: There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic. METHODS AND ANALYSIS: This is a national, multicentre, prospective cohort study involving 27 Swedish maternity units accounting for over 86 000 deliveries/year. Pregnant women are included when they: (1) test positive for SARS-CoV-2 (COVID-19 group) or (2) are non-infected and seek healthcare at one of their routine antenatal visits (screening group). Blood, as well as other biological samples, are collected at different time points during and after pregnancy. Child health up to 4 years of age and parent experience of pregnancy, delivery, early parenthood, healthcare and society in general will be examined using web-based questionnaires based on validated instruments. Short- and long-term health outcomes will be collected from Swedish health registers and the parents' experiences will be studied by performing qualitative interviews. ETHICS AND DISSEMINATION: Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (dnr 2020-02189 and amendments 2020-02848, 2020-05016, 2020-06696 and 2021-00870) and national biobank approval by the Biobank Väst (dnr B2000526:970). Results from the project will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04433364.


Assuntos
COVID-19 , Bancos de Espécimes Biológicos , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Humanos , Estudos Multicêntricos como Assunto , Pandemias , Gravidez , Resultado da Gravidez/epidemiologia , Estudos Prospectivos , SARS-CoV-2 , Inquéritos e Questionários
15.
Trials ; 22(1): 634, 2021 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-34530886

RESUMO

BACKGROUND: Optimal management of severe trauma patients with active hemorrhage relies on adequate initial resuscitation. Early administration of coagulation factors improves post-traumatic coagulation disorders, and four-factor prothrombin complex concentrate (PCC) might be useful in this context. Our main hypothesis is that four-factor PCC in addition to a massive transfusion protocol decreases blood product consumption at day 1 in severe trauma patients with major bleeding. METHODS: This is a prospective, randomized, multicenter, double-blind, parallel, controlled superiority trial. Eligible patients are trauma patients with major bleeding admitted to a French level-I trauma center. Patients randomized in the treatment arm receive 1 mL/kg (25 IU/ml of Factor IX/Kg) four-factor PCC within 1-h post-admission while patients randomized in the controlled group receive 1 mL/kg of saline solution 0.9% as a placebo. Treatments are given as soon as possible using syringe pumps (120 mL/h). The primary endpoint is the amount of blood products transfused in the first 24 h post-admission (including red blood cells, frozen fresh plasma, and platelets). The secondary endpoints are the amount of each blood product transfused in the first 24 h, time to achieve prothrombin time ratio < 1.5, time to hemostasis, number of thrombo-embolic events at 28 days, mortality at 24 h and 28 days, number of intensive care unit-free days, number of ventilator-free days, number of hospital-free days within the first 28 days, hospitalization status at day 28, Glasgow outcome scale extended for patients with brain lesions on initial cerebral imaging, and cost of each strategy at days 8 and 28. Inclusions have started in December 2017 and are expected to be complete by June 2021. DISCUSSION: If PCC reduces total blood consumption at day 1 after severe trauma, this therapy, in adjunction to a classic massive transfusion protocol, may be used empirically on admission in patients at risk of massive transfusion to enhance coagulation. Moreover, this treatment may decrease blood product-related complications and may improve clinical outcomes after post-traumatic hemorrhage. TRIAL REGISTRATION: ClinicalTrials.gov NCT03218722 . Registered on July 14, 2017.


Assuntos
Fatores de Coagulação Sanguínea , Fator IX , Fatores de Coagulação Sanguínea/efeitos adversos , Transfusão de Sangue , Humanos , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Trials ; 22(1): 617, 2021 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-34526073

RESUMO

BACKGROUND: Tonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired quality of life (QoL). Theoretically, removing all or part of the altered pathological palatal lymphoid tissue alleviates the symptoms and enhances the QoL. Whether this is true with total or partial tonsillar resection (tonsillectomy (TE) and tonsillotomy (TT), respectively) has not been reported in a randomised trial yet. METHODS: We conduct a multicentre, partly blinded, randomised, 6-month, parallel-group clinical study including 285 adult participants referred to surgical treatment for chronic or recurrent tonsillitis. The participants will either have TE, TT or watchful waiting (WW). The primary outcome will be the difference between the mean disease-specific Tonsillectomy Outcome Inventory-14 (QoL questionnaire) scores at 6 months. Comparison is made firstly between the combined TE+TT and WW groups (superiority analysis), and secondly between the TE and TT groups (non-inferiority analysis). DISCUSSION: This study will add significant new information to the effects and harms of TE and TT procedures in the treatment of adults with chronic or recurrent tonsillitis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04657549.


Assuntos
Tonsilectomia , Tonsilite , Adulto , Doença Crônica , Humanos , Estudos Multicêntricos como Assunto , Tonsila Palatina/cirurgia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Tonsilectomia/efeitos adversos , Tonsilite/diagnóstico , Tonsilite/cirurgia
17.
BMJ Open ; 11(9): e053610, 2021 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-34497087

RESUMO

INTRODUCTION: The ongoing pandemic could affect the duration, variety and severity of the mental, physical, and cognitive impairments intensive care unit (ICU) survivors and their families frequently present. We aim to determine the impact of the COVID-19 pandemic on the mental, physical, and cognitive health of survivors, the experience of their families and their treating healthcare professionals. METHODS AND ANALYSIS: Prospective, multicentre, mixed-methods cohort study in seven Chilean ICUs. SAMPLE: 450 adults, able to walk independently prior to admission, in ICU and mechanical ventilation >48 hours with and without COVID-19. Clinical Frailty Scale, Charlson comorbidity index, mobility (Functional Status Score for the Status Score for the Intensive Care Unit) and muscle strength (Medical Research Council Sum Score) will be assessed at ICU discharge. Cognitive functioning (Montreal Cognitive Assessment-blind), anxiety and depression (Hospital Anxiety and Depression Scale), post-traumatic stress (Impact of Event Scale-Revised) symptoms, disability (WHO Disability Assessment Schedule 2.0), quality of life (European Quality of Life Health Questionnaire), employment and survival will be assessed at ICU discharge, 3 months and 6 months. A sample will be assessed using actigraphy and the Global Physical Activity Questionnaire at 6 months after ICU discharge. Trajectories of mental, physical, and cognitive impairments will be estimated using multilevel longitudinal modelling. A sensitivity analysis using multiple imputations will be performed to account for missing data and loss-to-follow-up. Survival will be analysed using Kaplan-Meier curves. The perceptions of family members regarding the ICU stay and the later recovery will be explored 3 months after discharge. Healthcare professionals will be invited to discuss the challenges faced during the pandemic using semistructured interviews. Interviews will be thematically analysed by two independent coders to identify the main themes of the experience of family members and healthcare professionals. ETHICS AND DISSEMINATION: The study was approved by the Clinica Alemana Universidad del Desarrollo Ethics Committee (2020-78) and each participating site. Study findings will be published in peer-reviewed journals and disseminated through social media and conference meetings. TRIAL REGISTRATION NUMBER: NCT04979897.


Assuntos
COVID-19 , Pandemias , Adulto , Cognição , Estudos de Coortes , Cuidados Críticos , Humanos , Unidades de Terapia Intensiva , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Qualidade de Vida , SARS-CoV-2
18.
BMC Pediatr ; 21(1): 376, 2021 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-34470598

RESUMO

BACKGROUND: Research has highlighted the need for evidence-based interventions to improve paediatric advance care planning (pACP) in adolescents with cancer. Although adolescents express the desire and ability to share their values, beliefs and preferences for treatment, there is a lack of structured multicomponent interventions to improve parent-adolescent communication on different ACP themes including those not limited to end-of-life care. The aim of this study is to evaluate the effectiveness and implementation, context and mechanisms of impact of a novel ACP program in paediatric oncology. METHODS: We will conduct a multi-centre parallel-group randomised controlled superiority trial with embedded mixed-methods process evaluation in Flanders, Belgium. Adolescents aged 10-18 who have cancer, and their parent(s) will be recruited via all four university hospitals in Flanders, Belgium, and support groups. Families will be randomised to receive care as usual or the multicomponent BOOST pACP program, consisting of three conversation sessions between an external facilitator and the adolescent and parent(s). The primary endpoint is improved parent-adolescent communication from the perspective of the adolescent. Secondary endpoints are adolescents' and parents' attitudes, self-efficacy, intention and behaviour regarding talking about ACP themes with each other, parents' perspective of shared decision making in the last clinical encounter, and the paediatric oncologist's intention and behaviour regarding talking about ACP themes with the family. Measurements will be performed at baseline, at 3 months and at 7 months using structured self-reported questionnaires. We will perform a process evaluation in the intervention group, with measurement throughout and post-intervention, using structured diaries filled out by the facilitators, interviews with facilitators, interviews with involved paediatric oncology teams, and audio-recordings of the BOOST pACP conversations. DISCUSSION: The BOOST pACP program has been developed to stimulate conversations on ACP themes between parent(s) and the adolescents, simultaneously lowering the threshold to discuss similar themes with healthcare professionals, initiating a process of normalization and integration of ACP in standard care. This combined outcome and process evaluation aims to contribute to building the necessary evidence to improve ACP in paediatric oncology. TRIAL REGISTRATION: The study is registered at ISRCTN, ISRCTN33228289 . Registration date: January 22, 2021.


Assuntos
Planejamento Antecipado de Cuidados , Neoplasias , Assistência Terminal , Adolescente , Criança , Humanos , Estudos Multicêntricos como Assunto , Neoplasias/terapia , Pais , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e Questionários
19.
BMC Psychiatry ; 21(1): 439, 2021 09 06.
Artigo em Inglês | MEDLINE | ID: mdl-34488701

RESUMO

BACKGROUND: In people with intellectual disability (ID) and challenging behaviour, antipsychotics (AP) are often used off-label and for a long period. Despite a lack of evidence for efficacy for challenging behaviour and concerns about common and clinically relevant side effects, complete withdrawal often fails. We postulate three possible hypotheses for withdrawal failure: 1. Influence of subjective interpretation of behavioural symptoms by caregivers and family; 2. Beneficial effects from AP treatment on undiagnosed psychiatric illness, through improvement in sleep or a direct effect on behaviour; and 3. Misinterpretation of withdrawal symptoms as a recurrence of challenging behaviour. METHODS: To investigate our hypotheses, we have designed a multicentre double-blind, placebo-controlled randomised trial in which AP (pipamperone or risperidone) are withdrawn. In the withdrawal group, the AP dose is reduced by 25% every 4 weeks and in the control group the dose remains unaltered. Behaviour, sleep, psychiatric disorders, withdrawal symptoms and side effects will be measured and compared between the two groups. If drop-out from the protocol is similar in both groups (non-inferiority), the first hypothesis will be supported. If drop-out is higher in the withdrawal group and an increase is seen in psychiatric disorders, sleep problems and/or behavioural problems compared to the control group, this suggests effectiveness of AP, and indications for AP use should be reconsidered. If drop-out is higher in the withdrawal group and withdrawal symptoms and side effects are more common in the withdrawal group compared to the control group, this supports the hypothesis that withdrawal symptoms contribute to withdrawal failure. DISCUSSION: In order to develop AP withdrawal guidelines for people with ID, we need to understand why withdrawal of AP is not successful in the majority of people with ID and challenging behaviour. With this study, we will bridge the gap between the lack of available evidence on AP use and withdrawal on the one hand and the international policy drive to reduce prescription of AP in people with ID and challenging behaviour on the other hand. TRIAL REGISTRATION: This trial is registered in the Netherlands Trial Register (NTR 7232) on October 6, 2018 ( www.trialregister.nl ).


Assuntos
Antipsicóticos , Deficiência Intelectual , Adulto , Antipsicóticos/uso terapêutico , Sintomas Comportamentais , Método Duplo-Cego , Humanos , Deficiência Intelectual/complicações , Deficiência Intelectual/tratamento farmacológico , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Risperidona/uso terapêutico
20.
Clin Plast Surg ; 48(4): 607-616, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34503721

RESUMO

Melanoma tumor thickness and ulceration are the strongest predictors of nodal spread. The recommendations for sentinel lymph node biopsy (SLNB) have been updated in recent American Joint Committee on Cancer and National Comprehensive Cancer Network guidelines to include tumor thickness ≥0.8 mm or any ulcerated melanoma. Mitotic rate is no longer considered an indicator for determining T category. Improvements in disease-specific survival conferred from SLNB were demonstrated through level I data in the Multicenter Selective Lymphadenectomy Trial (MSLT) I. The role for completion lymph node dissection has evolved to less surgery in lieu of recent domestic (MSLT II) and international (Dermatologic Cooperative Oncology Group Selective Lymphadenectomy Trial [DeCOG-SLT]) level I data having similar melanoma-specific survival. Treatment options for the prevention of treatment of lymphedema have progressed to include immediate lymphatic reconstruction, lymphovenous anastomosis, and vascularized lymph node transfer.


Assuntos
Linfedema , Melanoma , Neoplasias Cutâneas , Humanos , Excisão de Linfonodo , Linfonodos/cirurgia , Metástase Linfática , Linfedema/cirurgia , Melanoma/cirurgia , Estudos Multicêntricos como Assunto , Biópsia de Linfonodo Sentinela , Neoplasias Cutâneas/cirurgia
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