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1.
BMJ Open Respir Res ; 8(1)2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34230034

RESUMEN

INTRODUCTION: Many respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers. METHODS: A respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP. RESULTS: On integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence. DISCUSSION: Integrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial.


Asunto(s)
COVID-19/terapia , Vías Clínicas , Selección de Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Hospitalización , Humanos , Terapia Respiratoria
3.
J Pediatr Health Care ; 35(4): 443-448, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34243845

RESUMEN

Critical appraisal of randomized controlled trials (RCTs) determines rigor, quality, and whether the findings are applicable to the populations served in clinical practices. The authors conducted a rigorous analysis using the RCT Critical Appraisal Skills Programme (CASP) Checklist for the two RCTs Pfizer (New York, NY) and Moderna (Cambridge, MA) conducted and the reporting of these RCTs using the Consolidated Standards of Reporting Trials checklist. The goals for this analysis were twofold: (1) enable health care providers to understand the methods and outcomes of these RCTs, and (2) enable health care providers and community leaders to become champions for the vaccines to reduce vaccine hesitancy among all populations. The analysis is presented using each of the 11 questions on the CASP tool while comparing the methodology and results for each vaccine. Most CASP tool items were positive or yes for both the Pfizer and Moderna RCTs. Items that were not scored as yes are discussed. The analysis outcomes revealed that both RCTs were rigorously conducted and provide an assurance to all health care providers and the public of the safety and efficacy of both vaccines to impact the astounding morbidity and mortality of COVID-19 disease. The authors believed that the analysis was an essential component of the distribution process to develop plans and communication strategies to reduce potential vaccine hesitancy and resistance.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Proyectos de Investigación/normas , COVID-19/epidemiología , Lista de Verificación , Humanos , SARS-CoV-2
5.
Maturitas ; 150: 1-6, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-34274071

RESUMEN

AIM: This longitudinal secondary analysis of the Multidomain Alzheimer Preventive Trial (MAPT) aimed to test whether the Integrated Care for Older People (ICOPE) Step 1 screening tool is able to identify people at risk of developing frailty and disability in basic (ADL) and instrumental (IADL) activities of daily living among community-dwelling older adults. PARTICIPANTS AND SETTING: Seven hundred and fifty-nine (n = 759) non-demented participants of the MAPT aged 70-89 years were assessed in memory clinics in France between 2008 and 2013. METHODS: We measured six intrinsic capacity (IC) impairments, adapted from the ICOPE screening tool. We used Cox models to estimate the adjusted hazard ratios of incident frailty and IADL/ADL disability. Incident frailty was defined by Fried's phenotype, and incident disability was measured according to Lawton and Katz for IADLs and ADLs. RESULTS: Limited mobility (HR= 2.97, 95%CI= 1.85-4.76), depressive symptoms (HR= 2.07, 95%CI= 1.03-4.19), and visual impairment (HR= 1.70, 95%CI 1.01-2.86) were associated with a higher incidence of frailty over 5 years. Each additional IC condition demonstrated a positive association with a higher risk of incident frailty, IADL, ADL disability, with risk increased by 47%, 27%, and 23% over 5 years, respectively. CONCLUSION: Screening for IC impairments identifies older adults at higher risk of incident frailty and incident IADL/ADL disability. It is relevant to screen for these impairments together because the risk of frailty and disability increases with each additional one. ClinicalTrials.gov identifier: NCT00672685.


Asunto(s)
Actividades Cotidianas , Enfermedad de Alzheimer/fisiopatología , Prestación Integrada de Atención de Salud/estadística & datos numéricos , Personas con Discapacidad/estadística & datos numéricos , Fragilidad/diagnóstico , Fragilidad/epidemiología , Tamizaje Masivo/métodos , Anciano , Anciano de 80 o más Años , Femenino , Anciano Frágil/estadística & datos numéricos , Francia/epidemiología , Humanos , Vida Independiente , Estudios Longitudinales , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación
7.
Artículo en Inglés | MEDLINE | ID: mdl-34200592

RESUMEN

Alongside glucose lowering therapy, clinical guidelines recommend lifestyle interventions as cornerstone in the care of people living with type 2 diabetes (T2DM). There is a specific need for an up-to-date review assessing the effectiveness of lifestyle interventions for people with T2DM living in low-and-middle income countries (MICs). Four electronic databases were searched for RCTs published between 1990 and 2020. T2DM, lifestyle interventions, LMICs and their synonyms were used as search terms. Data codebooks were developed and data were extracted. Narrative synthesis and meta-analysis were conducted using random effects models to calculate mean differences (MD) and standardized mean differences (SMD) and 95% confidence intervals (CI). Of 1284 articles identified, 30 RCTs (n = 16,670 participants) met the inclusion criteria. Pooled analysis revealed significant improvement in HBA1c (MD -0.63; CI: -0.86, -0.40), FBG (SMD -0.35; CI: -0.54, -0.16) and BMI (MD -0.5; CI: -0.8, -0.2). In terms of intervention characteristics, those that included promoted self-management using multiple education components (e.g., diet, physical activity, medication adherence, smoking cessation) and were delivered by healthcare professionals in a hospital/clinic setting were deemed most effective. However, when interpreting these results, it is important to consider that most included studies were evaluated as being of low quality and there was a significant amount of intervention characteristics heterogeneity. There is a need for further well-designed studies to inform the evidence base on which lifestyle interventions are most effective for glycemic control in adults with T2DM living in LMICs.


Asunto(s)
Países en Desarrollo , Diabetes Mellitus Tipo 2 , Adulto , Diabetes Mellitus Tipo 2/terapia , Control Glucémico , Humanos , Estilo de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto
8.
Artículo en Inglés | MEDLINE | ID: mdl-34200727

RESUMEN

Mastalgia, or breast pain, is common among women which can lead to significant impairment in daily living. Hence, finding an effective treatment that can alleviate the symptom is very important. Thus, we carry out this study to determine the efficacy of evening primrose oil (EPO) for mastalgia treatment in women. The review included published randomised clinical trials that evaluated EPO used for treating mastalgia against a placebo or other treatments, irrespective of the blinding procedure, publication status, or sample size. Two independent authors screened the titles and abstracts of the identified trials; full texts of relevant trials were evaluated for eligibility. Two reviewers independently extracted data on the methods, interventions, outcomes, and risk of bias. The random-effects model was used for estimating the risk ratios and mean differences with 95% confidence intervals. Thirteen trials with 1752 randomised patients were included. The results showed that EPO has no difference to reduce breast pain compared to topical NSAIDS, danazol, or vitamin E. The number of patients who achieved pain relief was no different compared to the placebo or other treatments. The EPO does not increase adverse events, such as nausea, abdominal bloating, headache or giddiness, increase weight gain, and altered taste compared to a placebo or other treatments. EPO is a safe medication with similar efficacy for pain control in women with mastalgia compared to a placebo, topical NSAIDS, danazol, or vitamin E.


Asunto(s)
Mastodinia , Femenino , Humanos , Ácidos Linoleicos/uso terapéutico , Mastodinia/tratamiento farmacológico , Aceites Vegetales/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Ácido gammalinolénico/uso terapéutico
9.
Artículo en Inglés | MEDLINE | ID: mdl-34200805

RESUMEN

Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild-moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021.


Asunto(s)
Depresión , Calidad de Vida , Depresión/terapia , Ejercicio Físico , Humanos , Motivación , Ensayos Clínicos Controlados Aleatorios como Asunto
10.
Trials ; 22(1): 462, 2021 Jul 18.
Artículo en Inglés | MEDLINE | ID: mdl-34275476

RESUMEN

BACKGROUND: With the expanded utilization of transcatheter aortic valve implantation (TAVI) to younger and lower surgical risk patients with severe aortic stenosis (AS), optimal medical therapy after TAVI procedure has become the main concern. Renin-angiotensin system inhibitors (RASi) are widely utilized in the area of cardiovascular disease including heart failure and myocardial infarction and revealed the ability to reverse left ventricular (LV) remodeling. Interests have, thus, been drawn in investigating whether the prescription of RASi after the TAVI procedure can prevent or reverse cardiac remodeling and improve long-term clinical outcomes. No recommendation regarding the prescription of RASi after TAVI is proposed yet due to the lack of evidence from randomized controlled trials, especially in the Chinese population. We, therefore, designed this randomized controlled trial to explore the effect of adding fosinopril to standard care in patients who underwent a successful TAVI procedure on the LV remodeling. METHODS: A total of 200 post-TAVI patients from seven academic hospitals across China will be recruited and randomized with a ratio of 1:1 to receive standard care or standard care plus fosinopril. Follow-up visits will take place at 30 days, 3 months, 6 months, 12 months, and 24 months from randomization to assess the clinical symptoms, any adverse events, cardiac function, and quality of life. Cardiac magnetic resonance will be performed at baseline and repeated at the 24-month follow-up visit to assess LV remodeling. DISCUSSION: This study will provide evidence regarding medical therapy for AS patients who underwent TAVI and filling the gap in the Chinese population. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100042266 . Registered on 17 January 2021.


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Inhibidores de la Enzima Convertidora de Angiotensina/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , China , Humanos , Estudios Multicéntricos como Asunto , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
11.
Ann Palliat Med ; 10(6): 6900-6908, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-34237987

RESUMEN

BACKGROUND: Central nervous system injury (CNSI) comprises a series of common diseases that severely affect patients' motor function and quality of life and is associated with high disability and mortality rates. Previous studies have shown that contralateral lumbosacral nerve root transfer significantly improved the function of the paralyzed limb in rat models of CNSI. These studies showed that severing the sacral 1 nerve root (S1) did not damage the function of the ipsilateral lower extremity. Thus, we speculate that contralateral S1 nerve root transfer can improve the recovery of a paralyzed limb. Because no associated rigorously designed randomized controlled trial has evaluated the effectiveness of contralateral S1 nerve transfer thus far, we designed this clinical trial to compare the effects of this new treatment approach with those of traditional treatments in paralyzed patients after chronic CNSI. METHODS: This is a single-center, prospective, randomized controlled trial. Forty patients, who meet the inclusion criteria and have hemiplegia caused by chronic CNSI, will be randomly divided into the surgical or non-surgical group. The treatment effect in the 2 groups will be assessed before and 3, 6, 9, 12, 18, and 24 months after intervention by using numerous scales and resting-state functional magnetic resonance imaging. The primary outcome will be the Fugl-Meyer score for the lower limbs 24 months after treatment. The secondary outcomes include the modified Ashworth spasm scale, the modified Barthel scale, 10-m walking speed measurement results, three-dimensional gait analysis, muscle strength testing, electromyography, and resting-state functional magnetic resonance imaging findings. Safety outcomes and adverse events will be observed simultaneously. DISCUSSION: We expect that the surgery will improve the sensorimotor functions of the paralyzed limb, and the results of this trial will provide high-quality clinical evidence for a new efficient treatment strategy for disability after CNSI. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR1800014414, registration date: 12 January 2018.


Asunto(s)
Transferencia de Nervios , Animales , Sistema Nervioso Central , Humanos , Extremidad Inferior , Estudios Prospectivos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Ratas , Recuperación de la Función , Resultado del Tratamiento
12.
Ann Palliat Med ; 10(6): 6909-6918, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-34237988

RESUMEN

BACKGROUND: Knee osteoarthritis (KOA) is a common joint disease worldwide, and the main cause of pain and disability in the elderly. Due to increased aging and rates of obesity of the global population, the number of patients with KOA is expected to increase. To reduce the burden of KOA, effective and safe interventions should be developed to reduce pain and improve range of motion, functionality, and quality of life. The aim of the proposed randomized controlled study was to evaluate the efficacy and safety of a traditional Chinese medicine (TCM) rehabilitation therapy in the treatment of KOA. METHODS: This multicenter, randomized, double-blind, parallel group, placebo-controlled trial will include a total of 200 patients with KOA. The enrolled patients will be randomly divided into the experimental group (n=100) and control group (n=100). The experimental group will receive basic treatment plus TCM rehabilitation therapy, while the control group will receive basic treatment plus physiotherapy regimen. Primary endpoints will include clinical efficacy outcomes, visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index score, and Knee Outcome Survey Activities of Daily Living Scale score. The data will help determine whether TCM rehabilitation therapy is beneficial for the treatment of KOA. DISCUSSION: The results will provide high-quality guidance for the current clinical treatment of KOA, and provide patients with more options for symptom relief. The findings from this study may provide updated evidence concerning the efficacy and safety of TCM for patients with KOA.


Asunto(s)
Osteoartritis de la Rodilla , Actividades Cotidianas , Anciano , Humanos , Medicina China Tradicional , Estudios Multicéntricos como Asunto , Dimensión del Dolor , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
13.
Trials ; 22(1): 437, 2021 Jul 08.
Artículo en Inglés | MEDLINE | ID: mdl-34238342

RESUMEN

BACKGROUND: Extensive-stage small-cell lung cancer (ES-SCLC) is characterized by extensive metastases, aggressive progression, and poor prognosis. Chemotherapy is applied as a preferred first-line regimen for ES-SCLC, but inadequate for improving its overall survival. Traditional Chinese medicine (TCM) is widely used in the clinical practice of ES-SCLC for its synergy with chemotherapy. However, there is still no substantial evidence to prove that TCM can effectively improve the long-term efficacy of ES-SCLC patients. The study intends to determine whether the TCM with chemotherapy can improve the overall survival (OS) in treating with ES-SCLC when compared with chemotherapy alone. METHOD/DESIGN: A multicenter, randomized, single-blind, placebo-controlled clinical trial will be conducted to determine whether the TCM granules combined with chemotherapy can improve the OS of ES-SCLC. Two hundred seventy participants will randomly receive 4-6 cycles (21 days per cycle) of chemotherapy plus TCM granules or placebo. The primary outcome measure is OS. The secondary outcome measures includes progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and tumor markers. Visits will be performed at the end of each cycle during the treatment period and then every 3 months in the follow-up period until the patients' death or study completion. DISCUSSION: The study's result will provide a high-level evidence for TCM granules using with chemotherapy on the first-line treatment of ES-SCLC. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900022991 . Registered on 6 May 2019 (prospective registration).


Asunto(s)
Neoplasias Pulmonares , Medicina China Tradicional , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Método Doble Ciego , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Estudios Multicéntricos como Asunto , Estudios Prospectivos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego
14.
Trials ; 22(1): 438, 2021 Jul 08.
Artículo en Inglés | MEDLINE | ID: mdl-34238363

RESUMEN

BACKGROUND: High blood pressure is an independent risk factor of cardiovascular disease (CVD) and is a major cause of disability and death. Managing a healthy lifestyle has been shown to reduce blood pressure and improve health outcomes. We aim to investigate the effectiveness of a lifestyle modification intervention program for lowering blood pressure in a rural area of Bangladesh. METHODS: A single-center cluster randomized controlled trial (RCT). The study will be conducted for 6 months, a total of 300 participants of age 30 to 75 years with 150 adults in each of the intervention and the control arms. The intervention arm will involve the delivery of a blended learning education program on lifestyle changes for the management of high blood pressure. The education program comprises evidence-based information with pictures, fact sheets, and published literature about the effects of high blood pressure on CVD development, increased physical activity, and the role of a healthy diet in blood pressure management. The control group involves providing information booklets and general advice at the baseline data collection point. The primary outcome will be the absolute difference in clinic SBP and DBP. Secondary outcomes include the difference in the percentage of people adopting regular exercise habits, cessation of smoking and reducing sodium chloride intake, health literacy of all participants, and the perceived barriers and enablers to adopt behavior changes by collecting qualitative data. Analyses will include analysis of covariance to report the mean difference in blood pressure between the control and the intervention group and the difference in change in blood pressure due to the intervention. DISCUSSION: The study will assess the effects of physical activity and lifestyle modification in controlling high blood pressure. This study will develop new evidence as to whether a simple lifestyle program implemented in a rural region of a low- and middle-income country will improve blood pressure parameters for people with different chronic diseases by engaging community people. TRIAL REGISTRATION: ClinicalTrials.gov NCT04505150 . Registered on 7 August 2020.


Asunto(s)
Enfermedades Cardiovasculares , Hipertensión , Adulto , Anciano , Bangladesh , Presión Sanguínea , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/prevención & control , Humanos , Hipertensión/diagnóstico , Hipertensión/prevención & control , Estilo de Vida , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto
15.
Trials ; 22(1): 443, 2021 Jul 12.
Artículo en Inglés | MEDLINE | ID: mdl-34247628

RESUMEN

BACKGROUND: Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce-with patient partners and other key stakeholders-a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials. METHODS: The study will have five-stages which will include the following: (i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; (ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; (iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; (iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; and (v) an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set. DISCUSSION: Development of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.


Asunto(s)
Fracturas de Tobillo , Fracturas de Tobillo/diagnóstico por imagen , Fracturas de Tobillo/terapia , Técnica Delfos , Humanos , Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Tibia , Resultado del Tratamiento
16.
Artículo en Inglés | MEDLINE | ID: mdl-34200510

RESUMEN

The aim of this study was to describe and update current knowledge of manual therapy accuracy in treating cervical and lumbar radiculopathy, to identify the limitations in current studies, and to suggest areas for future research. The study was conducted according to PRISMA guidelines for systematic reviews. A comprehensive literature review was conducted using PubMed and Web of Science databases up to April 2020. The following inclusion criteria were used: (1) presence of radiculopathy; (2) treatment defined as manual therapy (i.e., traction, manipulation, mobilization); and (3) publication defined as a Randomized Controlled Trial. The electronic literature search resulted in 473 potentially relevant articles. Finally, 27 articles were accepted: 21 on cervical (CR) and 6 in lumbar radiculopathy (LR). The mean PEDro score for CR was 6.6 (SD 1.3), and for LR 6.7 (SD 1.6). Traction-oriented techniques are the most frequently chosen treatment form for CR and are efficient in reducing pain and improving functional outcomes. In LR, each of the included publications used a different form of manual therapy, which makes it challenging to summarize knowledge in this group. Of included publications, 93% were either of moderate or low quality, which indicates that quality improvement is necessary for this type of research.


Asunto(s)
Manipulaciones Musculoesqueléticas , Radiculopatía , Humanos , Cuello , Dolor de Cuello , Radiculopatía/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Tracción
17.
Medicine (Baltimore) ; 100(27): e25743, 2021 Jul 09.
Artículo en Inglés | MEDLINE | ID: mdl-34232163

RESUMEN

INTRODUCTION: The effect of perioperative omega-3 fatty acids for liver surgery remained controversial. We conducted a systematic review and meta-analysis to explore the influence of omega-3 fatty acids versus placebo in patients undergoing liver surgery. METHODS: We have searched PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through May 2020, and included randomized controlled trials (RCTs) assessing the effect of omega-3 fatty acids versus placebo for liver surgery. This meta-analysis was performed using the random-effect model. RESULTS: Five RCTs were included in the meta-analysis. Overall, compared with control group for liver surgery, omega-3 fatty acids were associated with substantially reduced incidence of infection (odd ratio [OR]=0.56; 95% confidence interval [CI] =0.34-0.91; P = .02), but revealed no remarkable influence on complications (OR = 0.60; 95% CI = 0.29-1.24; P = .17), mortality (OR = 0.76; 95% CI = 0.06-9.37; P = .83), liver failure (OR = 0.72; 95% CI = 0.10 to 5.00; P = 0.74), biliary leakage (OR=1.24; 95% CI = 0.41 to 3.76; P = .70), bleeding (OR = 1.76; 95% CI = 0.63-4.95; P = .28), or ileus (OR = 0.39; 95% CI = 0.07-2.05; P = .27). CONCLUSION: Perioperative omega-3 fatty acids may be beneficial to reduce the incidence of infection after liver surgery.


Asunto(s)
Ácidos Grasos Omega-3/uso terapéutico , Hepatectomía , Hepatopatías/cirugía , Atención Perioperativa/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Suplementos Dietéticos , Humanos
18.
BMC Musculoskelet Disord ; 22(1): 611, 2021 Jul 09.
Artículo en Inglés | MEDLINE | ID: mdl-34243746

RESUMEN

BACKGROUND: Although many people with chronic low back pain (LBP) improve following conservative treatment, one in five will experience worsening symptoms after discharge from treatment and seek health care again. The current LBP clinical care pathway in many health services lacks a well-integrated, systematic approach to support patients to remain physically active and self-manage their symptoms following discharge from treatment. Health coaching can support people to improve physical activity levels and may potentially reduce health care utilisation for LBP. The primary aim of this study is to evaluate the effect of introducing a coordinated support system (linking hospital outpatient physiotherapy services to a public health coaching service) at discharge from LBP treatment, on the future use of hospital, medical, and health services for LBP, compared with usual care provided at discharge. METHODS: Three hundred and seventy-four adults with chronic non-specific LBP will be recruited from the outpatient physiotherapy departments of public hospitals in New South Wales, Australia. Participants will be individually randomised to a support system (n = 187) or usual care group (n = 187). All participants will receive usual care provided at discharge from treatment. Participants allocated to the support system will also receive up to 10 telephone-based health coaching sessions, delivered by the Get Healthy Service®, over a 6-month period. Health coaches will monitor and support participants to improve physical activity levels and achieve personal health-related goals. The primary outcome is the total number of encounters with hospital, medical, and health services for LBP, at 12 months from baseline. A within-trial economic evaluation will quantify the incremental costs and benefits of the support system from a health system perspective, to support reimbursement decision making. DISCUSSION: This study will establish the effect of a coordinated support system, introduced at discharge from treatment, on the future use of hospital, medical, and health services for LBP and various health outcomes. CONCLUSION: Innovative community-driven solutions to support people with chronic LBP after discharge from treatment are urgently needed. Study findings will help inform health care policy and clinical practice in Australia. TRIAL REGISTRATION: Prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12620000889954 ) on 10/09/2020.


Asunto(s)
Dolor de la Región Lumbar , Tutoría , Adulto , Australia , Hospitales Públicos , Humanos , Dolor de la Región Lumbar/diagnóstico , Dolor de la Región Lumbar/terapia , Nueva Gales del Sur , Alta del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
19.
Trials ; 22(1): 439, 2021 Jul 09.
Artículo en Inglés | MEDLINE | ID: mdl-34243808

RESUMEN

BACKGROUND: Many therapeutic interventions are performed by physiotherapists to improve upper extremity function and/or activities of daily living (ADL) in stroke patients. Mirror therapy (MT) is a simple technique that can be self-administered by the patients with intact cognition following patient education by a skilled physiotherapist. However, the effectiveness of self-administered MT in post-stroke patients in upper extremity function remains unclear. Therefore, the objective of this study is to examine the effectiveness of MT in improving upper extremity function and recovery in acute stroke patients. METHODS: This study is a single-center, prospective, randomized, open-label, controlled trial with blinded outcome evaluation (PROBE design), in which a total of 36 eligible acute stroke patients will be randomly assigned to control (n=18) and experimental group (n=18). Participants in the control group will receive regular rehabilitation interventions whereas participants in the experimental group will receive MT education in addition to their regular interventions for 4 weeks. STUDY OUTCOME: The primary outcome measure will be upper extremity function that will be measured using the Fugl-Meyer Assessment scale and the Wolf Motor Function Test. The secondary outcome measure will be behaviors related to ADL as estimated using the Modified Barthel Index. Outcome measures will be assessed at baseline and at 4 weeks post-rehabilitation intervention/MT. RESULTS: A two-way repeated analysis of variance (ANOVA) with time and group effects will be used to analyze between-group differences. The level of significance will be set at P < 0.05. CONCLUSION: The results of the study will provide critical information to include self-administered MT as an adjuvant to regular interventions and may facilitate recovery of the upper extremity function of stroke patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04542772 . Registered on 9 September 2020. Protocol version: Final 1.0.


Asunto(s)
Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular , Actividades Cotidianas , Humanos , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Recuperación de la Función , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/terapia , Resultado del Tratamiento , Extremidad Superior
20.
BMJ Open ; 11(6): e050582, 2021 06 30.
Artículo en Inglés | MEDLINE | ID: mdl-34193503

RESUMEN

INTRODUCTION: Infection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms. METHODS AND ANALYSIS: In this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages. ETHICS AND DISSEMINATION: The study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals. TRIAL REGISTRATION NUMBER: NCT04530435; Pre-results.


Asunto(s)
COVID-19 , Actividades Cotidianas , Hospitalización , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , SARS-CoV-2 , Autocuidado , Resultado del Tratamiento
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