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1.
Bone Joint J ; 101-B(12): 1550-1556, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31786993

RESUMO

AIMS: The aim of this study was to examine trends in the management of fractures of the distal radius in Ireland over a ten-year period, and to determine if there were any changes in response to the English Distal Radius Acute Fracture Fixation Trial (DRAFFT). PATIENTS AND METHODS: Data was grouped into annual intervals from 2008 to 2017. All adult inpatient episodes that involved emergency surgery for fractures of the distal radius were included. RESULTS: In 2008 Kirschner-wire (K-wire) fixation accounted for 59% of operations for fractures of the distal radius, and plate fixation for 21%. In 2017, the rate of K-wire fixation had fallen to 30%, and the proportion of patients who underwent plate fixation had risen to 62%. CONCLUSION: There is an increasing trend towards open reduction and internal fixation for fractures of the distal radius in Ireland. This has been accompanied by a decrease in popularity for K-wire fixation. DRAFFT did not appear to influence trends in the management of fractures of the distal radius in Ireland. Cite this article: Bone Joint J 2019;101-B:1550-1556.


Assuntos
Fixação Interna de Fraturas/tendências , Padrões de Prática Médica/tendências , Fraturas do Rádio/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Placas Ósseas , Fios Ortopédicos , Feminino , Fixação Interna de Fraturas/instrumentação , Fixação Interna de Fraturas/métodos , Humanos , Irlanda , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Razão de Chances , Ensaios Clínicos Pragmáticos como Assunto , Adulto Jovem
2.
Bone Joint J ; 101-B(12): 1472-1475, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31787004

RESUMO

The Ankle Injury Management (AIM) trial was a pragmatic equivalence randomized controlled trial conducted at 24 hospitals in the United Kingdom that recruited 620 patients aged more than 60 years with an unstable ankle fracture. The trial compared the usual care pathway of early management with open reduction and internal fixation with initially attempting non-surgical management using close contact casting (CCC). CCC is a minimally padded cast applied by an orthopaedic surgeon after closed reduction in the operating theatre. The intervention groups had equivalent functional outcomes at six months and longer-term follow-up. However, potential barriers to using CCC as an initial form of treatment for these patients have been identified. In this report, the results of the AIM trial are summarized and the key issues are discussed in order to further the debate about the role of CCC. Evidence from the AIM trial supports surgeons considering conservative management by CCC as a treatment option for these patients. The longer-term follow-up emphasized that patients treated with CCC need careful monitoring in the weeks after its application to monitor maintenance of reduction. Cite this article: Bone Joint J 2019;101-B:1472-1475.


Assuntos
Fraturas do Tornozelo/cirurgia , Traumatismos do Tornozelo/cirurgia , Moldes Cirúrgicos , Redução Fechada/métodos , Tratamento Conservador/métodos , Fixação Interna de Fraturas/métodos , Idoso , Idoso de 80 Anos ou mais , Redução Fechada/instrumentação , Tratamento Conservador/instrumentação , Estudos de Equivalência como Asunto , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Pós-Operatórios/métodos , Ensaios Clínicos Pragmáticos como Assunto , Resultado do Tratamento
3.
BMC Public Health ; 19(1): 1462, 2019 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-31694586

RESUMO

BACKGROUND: The number of interventions to support parents is growing. The level of evidence regarding these intervention varies. In this paper we describe a study that aims to assess the effectiveness of specific 'elements' within such parenting interventions for families with children up to 7 years. A naturalistic effect evaluation will be applied. Study questions are: 1. What is the exposure of parents to (elements of) parenting interventions in the daily practice of preventive youth health care? 2. What are the associations between the exposure to (elements of) parenting interventions and outcomes in parents/children related to parenting and child development? METHODS/DESIGN: Thousand parents/caregivers are recruited by preventive youth health care providers in the Netherlands. Measurements will be performed after inclusion and after 12-months follow up. Data regarding child/parent/caregiver characteristics, use of (parenting) interventions and care, and outcomes with regard to parenting skills, family functioning and child development will be collected. Outcomes will be compared between parents/children exposed and non-exposed to the (elements of) parenting interventions (adjusting for confounders). DISCUSSION: We hypothesize that parents/caregivers with exposure to (elements of) parenting interventions show (relatively more) improvements in parenting outcomes. Results will support intervention selection/development, and support communities/professionals to select appropriate intervention-elements. TRIAL REGISTRATION: Netherlands National Trial Register number NL7342 . Date of registration: 05-November-2018, retrospectively registered.


Assuntos
Poder Familiar , Medicina Preventiva/métodos , Apoio Social , Adolescente , Criança , Desenvolvimento Infantil , Educação Infantil , Pré-Escolar , Educação não Profissionalizante , Feminino , Humanos , Masculino , Países Baixos , Relações Pais-Filho , Pais/psicologia , Ensaios Clínicos Pragmáticos como Assunto , Projetos de Pesquisa
4.
Trials ; 20(1): 560, 2019 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-31511041

RESUMO

BACKGROUND: Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing with either preconditioning or postconditioning or assessing a single aspect of cardioprotection have shown conflicting results. We tested the hypothesis that a multimodal approach would improve cardioprotection and limit myocardial damage following cardiac surgery with cardiopulmonary bypass. METHODS: This study is a pragmatic multicenter (six French institutions), prospective, randomized, single-blinded, controlled trial. The randomization is stratified by centers. In the study, 210 patients scheduled for aortic valve surgery with or without coronary artery bypass grafting will be assigned to a control or a treatment group (105 patients in each group). In the control group, patients receive total intravenous anesthesia with propofol and liberal intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 60 min, is greater than 180 mg/dl), as a standard of care. The treatment group receives a bundle of care combining five techniques of cardioprotection: (1) remote ischemic preconditioning applied before aortic cross-clamping; (2) maintenance of anesthesia with sevoflurane; (3) tight intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 30 min, is greater than 140 mg/dl); (4) moderate respiratory acidosis (pH 7.30) at the end of cardiopulmonary bypass; and (5) a gentle reperfusion protocol following aortic unclamping. The primary outcome is myocardial damage measured by postoperative 72-h area under the curve of high-sensitivity cardiac troponin I. DISCUSSION: The ProCCard study will be the first multicenter randomized controlled trial aiming to assess the role of a bundle of care combining several cardioprotective strategies to reduce myocardial damage in patients undergoing cardiac surgery with cardiopulmonary bypass. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03230136 . Registered on July 26, 2017. Last updated on April 17, 2019.


Assuntos
Valva Aórtica/cirurgia , Ponte de Artéria Coronária , Ensaios Clínicos Pragmáticos como Assunto , Glicemia/análise , Ponte Cardiopulmonar/efeitos adversos , Ponte de Artéria Coronária/efeitos adversos , Humanos , Precondicionamento Isquêmico , Estudos Prospectivos , Projetos de Pesquisa , Método Simples-Cego
5.
Trials ; 20(1): 556, 2019 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-31500656

RESUMO

BACKGROUND: Good Clinical Practice guidelines issued in 2016 encourage risk-based approaches to monitoring clinical trials. This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units (CTUs) with the published guidance and makes recommendations for risk-based monitoring in pragmatic trials. METHODS: An online survey of UK Clinical Research Collaboration registered CTUs was administered via email invitation. Forty-nine units were invited, and 23 responded. Respondents were also invited to share copies of risk assessment templates. RESULTS: Most CTUs reported using remote combined with on-site monitoring. All reported undertaking a risk assessment for Clinical Trials of Investigational Medicinal Products (CTIMPs) and 21 units did so for non-CTIMPs. Most CTIMP risk assessments used MHRA (Medicines and Healthcare products Regulatory Agency) classifications, although some also employed staff judgement. Almost all units based their monitoring on perceived risk level; this number was higher for CTIMPs (n = 22) than for non-CTIMPs (n = 19). In most cases, monitoring plans were produced. More CTUs revisited risk assessments during trials in CTIMPs (n = 21) than in non-CTIMPs (n = 18). Small numbers of units reviewed the monitoring approach always (n = 4) or sometimes (n = 9) and few used the reflection to guide future monitoring. CONCLUSIONS: A high proportion of UK CTUs are using risk-based monitoring in the UK, as recommended by guidelines, for both CTIMPs and non-CTIMPs. This has the potential to make trials more efficient and reduce costs. However, there appears to be a lack of reflection on the value of these revised approaches. There may be a benefit in CTUs collaborating nationally to improve processes for reflection and making changes during the life course of a trial.


Assuntos
Ensaios Clínicos Pragmáticos como Assunto , Medição de Risco , Humanos , Reino Unido
6.
Trials ; 20(1): 472, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-31370871

RESUMO

BACKGROUND: There is increasing recognition of the need to stabilize sleep-wake cycles in individuals with major mental disorders. As such, clinicians and researchers advocate the use of interventions targeted at sleep and circadian dysrhythmias as an adjunct to the standard treatments offered for acute illness episodes of a broad range of diagnoses. To determine the trans-diagnostic generalizability of chronotherapy, we explore the benefits of admitting individuals with an acute illness episode to a psychiatric inpatient unit where changes in light exposure are integrated into the therapeutic environment. METHODS/DESIGN: A two-arm, pragmatic effectiveness, randomized controlled treatment trial, where individuals admitted for acute inpatient psychiatric care will be allocated to a ward with blue-depleted evening light or to a ward with the same layout and facilities but lacking the new lighting technology. The trial will test whether the experimental lighting conditions offer any additional benefits beyond those associated with usual treatment in an acute psychiatric inpatient unit. The main objectives are to examine any differences between groups in the mean duration of hospitalization in days. Additional analyses will compare group differences in symptoms, functioning, medication usage, and side effects and whether length of stay is associated with stability of sleep-wake cycles and circadian rhythms. Ancillary investigations should determine any benefits according to diagnostic subgroups and potential drawbacks such as any adverse effects on the well-being of professionals working across both wards. DISCUSSION: This unit offers a unique opportunity to explore how exposure to different lighting conditions may modify sleep-wake cycles and how any changes in sleep-wake cycle may impact on the clinical and functional outcomes of individuals experiencing an acute episode of a severe mental disorder that requires inpatient care. The findings could influence the future design of hospital units offering care to patients with mental or physical disorders. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03788993 . Retrospectively registered on 28 December 2018.


Assuntos
Cronoterapia , Terapia pela Cor , Iluminação , Transtornos Mentais/terapia , Quartos de Pacientes , Sono , Doença Aguda , Cronoterapia/efeitos adversos , Terapia pela Cor/efeitos adversos , Humanos , Transtornos Mentais/diagnóstico , Transtornos Mentais/fisiopatologia , Transtornos Mentais/psicologia , Noruega , Admissão do Paciente , Ensaios Clínicos Pragmáticos como Assunto , Fatores de Tempo , Resultado do Tratamento
7.
BMC Pulm Med ; 19(1): 143, 2019 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-31387559

RESUMO

BACKGROUND: A minority of patients presenting with lower respiratory tract infection (LRTI) to their general practitioner (GP) have community-acquired pneumonia (CAP) and require antibiotic therapy. Identifying them is challenging, because of overlapping symptomatology and low diagnostic performance of chest X-ray. Procalcitonin (PCT) can be safely used to decide on antibiotic prescription in patients with LRTI. Lung ultrasound (LUS) is effective in detecting lung consolidation in pneumonia and might compensate for the lack of specificity of PCT. We hypothesize that combining PCT and LUS, available as point-of care tests (POCT), might reduce antibiotic prescription in LRTIs without impacting patient safety in the primary care setting. METHODS: This is a three-arm pragmatic cluster randomized controlled clinical trial. GPs are randomized either to PCT and LUS-guided antibiotic therapy or to PCT only-guided therapy or to usual care. Consecutive adult patients with an acute cough due to a respiratory infection will be screened and included if they present a clinical pneumonia as defined by European guidelines. Exclusion criteria are previous antibiotics for the current episode, working diagnosis of sinusitis, severe underlying lung disease, severe immunosuppression, hospital admission, pregnancy, inability to provide informed consent and unavailability of the GP. Patients will fill in a 28 day-symptom diary and will be contacted by phone on days 7 and 28. The primary outcome is the proportion of patients prescribed any antibiotic up to day 28. Secondary outcomes include clinical failure by day 7 (death, admission to hospital, absence of amelioration or worsening of relevant symptoms) and by day 28, duration of restricted daily activities, episode duration as defined by symptom score, number of medical visits, number of days with side effects due to antibiotics and a composite outcome combining death, admission to hospital and complications due to LRTI by day 28. An evaluation of the cost-effectiveness and of processes in the clinic using a mixed qualitative and quantitative approach will also be conducted. DISCUSSION: Our intervention targets only patients with clinically suspected CAP who have a higher pretest probability of definite pneumonia. The intervention will not substitute clinical assessment but completes it by introducing new easy-to-perform tests. TRIAL REGISTRATION: The study was registered on the 19th of June 2017 on the clinicaltrials.gov registry using reference number; NCT03191071 .


Assuntos
Antibacterianos/uso terapêutico , Infecções Comunitárias Adquiridas/tratamento farmacológico , Testes Imediatos , Pró-Calcitonina/sangue , Infecções Respiratórias/tratamento farmacológico , Antibacterianos/efeitos adversos , Biomarcadores/sangue , Infecções Comunitárias Adquiridas/diagnóstico por imagem , Hospitalização , Humanos , Modelos Logísticos , Estudos Multicêntricos como Assunto , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Ensaios Clínicos Pragmáticos como Assunto , Infecções Respiratórias/diagnóstico por imagem , Ultrassonografia
8.
Stud Health Technol Inform ; 264: 1544-1545, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438223

RESUMO

Pragmatic randomized trials are essential to improve knowledge of real world clinical practice. Pragmatic trials design reflect routine clinical care, which have advantages to initiate and conduct, compared to classical clinical trials. Trials help to: engage bedside clinicians, increase efficiency of patient recruitment and follow up, minimize loss to follow up and include technological patient reported outcomes. The objective is to describe the opportunities and challenges designing a specialized software to administrate pragmatic randomized trials.


Assuntos
Ensaios Clínicos Pragmáticos como Assunto , Projetos de Pesquisa , Software , Humanos , Seleção de Pacientes
9.
Trials ; 20(1): 536, 2019 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-31462284

RESUMO

BACKGROUND: Tuberculosis is one of the greatest global health concerns and disease management is challenging particularly in low- and middle-income countries. Despite improvements in addressing this epidemic in Georgia, tuberculosis remains a significant public health concern due to sub-optimal patient management. Low remuneration for specialists, limited private-sector interest in provision of infectious disease care and incomplete integration in primary care are at the core of this problem. METHODS: This protocol sets out the methods of a two-arm cluster randomized control trial which aims to generate evidence on the effectiveness of a performance-based financing and integrated care intervention on tuberculosis loss to follow-up and treatment adherence. The trial will be implemented in health facilities (clusters) under-performing in tuberculosis management. Eligible and consenting facilities will be randomly assigned to either intervention or control (standard care). Health providers within intervention sites will form a case management team and be trained in the delivery of integrated tuberculosis care; performance-related payments based on monthly records of patients adhering to treatment and quality of care assessments will be disbursed to health providers in these facilities. The primary outcomes include loss to follow-up among adult pulmonary drug-sensitive and drug-resistant tuberculosis patients. Secondary outcomes are adherence to treatment among drug-sensitive and drug-resistant tuberculosis patients and treatment success among drug-sensitive tuberculosis patients. Data on socio-demographic characteristics, tuberculosis diagnosis and treatment regimen will also be collected. The required sample size to detect a 6% reduction in loss to follow-up among drug-sensitive tuberculosis patients and a 20% reduction in loss to follow-up among drug-resistant tuberculosis patients is 948 and 136 patients, respectively. DISCUSSION: The trial contributes to a limited body of rigorous evidence and literature on the effectiveness of supply-side performance-based financing interventions on tuberculosis patient outcomes. Realist and health economic evaluations will be conducted in parallel with the trial, and associated composite findings will serve as a resource for the Georgian and wider regional Ministries of Health in relation to future tuberculosis and wider health policies. The trial and complementing evaluations are part of Results4TB, a multidisciplinary collaboration engaging researchers and Georgian policy and practice stakeholders in the design and evaluation of a context-sensitive tuberculosis management intervention. TRIAL REGISTRATION: ISRCTN, ISRCTN14667607 . Registered on 14 January 2019.


Assuntos
Antituberculosos/uso terapêutico , Administração de Caso/economia , Prestação Integrada de Cuidados de Saúde/economia , Avaliação de Desempenho Profissional/economia , Padrões de Prática Médica/economia , Reembolso de Incentivo/economia , Tuberculose/tratamento farmacológico , Tuberculose/economia , República da Geórgia , Fidelidade a Diretrizes/economia , Humanos , Guias de Prática Clínica como Assunto , Ensaios Clínicos Pragmáticos como Assunto , Fatores de Tempo , Resultado do Tratamento , Tuberculose/diagnóstico , Tuberculose/microbiologia
10.
Trials ; 20(1): 423, 2019 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-31296249

RESUMO

BACKGROUND: This study aims to determine whether 3 sessions per week of acupuncture treatment is superior to 1 session per week of acupuncture treatment for symptomatic outcomes in knee osteoarthritis. METHODS/DESIGN: This is a two parallel-group, assessor-blinded, randomized controlled trial. Sixty patients with knee osteoarthritis (Kellgren-Lawrence grade II or III) will be recruited and randomly allocated to receive 24 or 8 sessions (group M or group L) of acupuncture treatment in a 1:1 ratio. Patients in group M will receive 3 sessions per week of acupuncture for 8 weeks. Patients in group L will receive acupuncture once per week for 8 weeks. The primary outcome is the response rate-the percentage of patients achieving a decrease ≥ 2 points on a numerical rating pain scale and a decrease ≥ 6 points in the Western Ontario and McMaster Universities Osteoarthritis Index function score at 8 weeks compared with baseline. Secondary outcomes include pain, function, overall effect, quality of life, and treatment credibility and expectancy. DISCUSSION: Three sessions per week of acupuncture treatment may be superior to 1 session per week of acupuncture treatment for symptomatic outcomes in knee osteoarthritis. Results of the study will be of great importance for the guidelines of clinical therapy. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03359603 . Registered on 1 December 2017.


Assuntos
Terapia por Acupuntura/métodos , Osteoartrite do Joelho/terapia , Terapia por Acupuntura/efeitos adversos , Idoso , Pequim , Avaliação da Deficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/diagnóstico , Osteoartrite do Joelho/fisiopatologia , Medição da Dor , Projetos Piloto , Ensaios Clínicos Pragmáticos como Assunto , Fatores de Tempo , Resultado do Tratamento
11.
Trials ; 20(1): 412, 2019 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-31288859

RESUMO

BACKGROUND: Opioid use has risen to epidemic proportions across Canada, with increasing evidence of harms including accidental overdose and death. Policy-makers have called for effective approaches to promote opioid reduction. One promising method from deprescribing randomized trials is to empower patients through direct-to-patient education. The current trial will evaluate the effectiveness of a government-led mail-out of educational information to adult community-dwelling, chronic opioid users on the reduction of opioids compared to usual care. METHODS: This is a pragmatic, prospective, cluster randomized, parallel-arm controlled trial, comparing mailed distribution of a direct-to-patient educational brochure for chronic opioid use (intervention arm) to usual care (control arm). Eligible participants from across Manitoba, Canada, will be identified by the Provincial Drug Programs Branch within the Manitoba Health, Seniors and Active Living Department of the Manitoba Government, allocated to primary care providers, and the latter will be randomized in clusters of family medicine practices to achieve a 1:1 ratio. The primary outcome is complete cessation of opioids after 6 months assessed using Drug Program Information Network data. Secondary outcomes include ≥ 25% dose reduction in the mean morphine milligram equivalent (MME) daily dose, reduction of daily dose to < 90 mg MME, or therapeutic switch to another opioid or non-opioid medication. Data will be analyzed using intent-to-treat generalized estimating equations. DISCUSSION: This trial will test the efficacy of a population-based, wide-scale, government-led direct-to-patient educational initiative to drive reductions in chronic opioid use by community-dwelling adults across Manitoba. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03400384 . Registered on 18 January 2018.


Assuntos
Analgésicos Opioides/administração & dosagem , Dor Crônica/tratamento farmacológico , Desprescrições , Substituição de Medicamentos , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Folhetos , Educação de Pacientes como Assunto/métodos , Analgésicos Opioides/efeitos adversos , Dor Crônica/diagnóstico , Dor Crônica/psicologia , Esquema de Medicação , Conhecimentos, Atitudes e Prática em Saúde , Política de Saúde , Humanos , Manitoba , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/psicologia , Formulação de Políticas , Serviços Postais , Ensaios Clínicos Pragmáticos como Assunto , Estudos Prospectivos , Fatores de Proteção , Medição de Risco , Fatores de Risco , Fatores de Tempo
12.
Trials ; 20(1): 441, 2019 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-31315670

RESUMO

BACKGROUND: Spine surgery is associated with considerable postoperative pain and can be challenging to treat. A loco-regional technique suitable for spine surgery should cover the dorsal root of the spinal nerves at the levels where surgery is performed. The erector spinae block is a loco-regional technique with promising results and was recently described at the thoracic level. There are no randomized trials of this technique on a lumbar level. This study tests the hypothesis that the 24-h postoperative morphine consumption is significantly lower in patients undergoing posterior lumbar inter-body fusion surgery with a lumbar erector spinae (LUMBES) block when compared with a sham block. METHODS: This prospective randomized double-blind multicenter study will randomly allocate 80 adult patients undergoing elective posterior lumbar inter-body fusion surgery during general anesthesia to one of two groups as follows: (1) bilateral erector spinae block (20 mL 0.25% levobupivacaine) or (2) bilateral sham block (20 mL NaCl 0.9%). Our primary endpoint is 24-h postoperative morphine consumption. Secondary endpoints include 72-h morphine consumption, intraoperative sufentanil dosage, postoperative pain scores at regular time intervals both at rest and during movement, time to first postoperative mobilization, and the Quality of Recovery 40 survey score. DISCUSSION: The LUMBES trial is a pragmatic clinical study that will provide evidence of whether a bilateral lumbar erector spinae block is effective in reducing 24-h postoperative morphine consumption in patients undergoing lumbar inter-body fusion surgery. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of this technique. TRIAL REGISTRATION: Local ethics committee B300201837508, ClinicalTrials.gov identifier: NCT03825198 . Registered on 31 Jan 2019.


Assuntos
Analgésicos Opioides/administração & dosagem , Anestésicos Locais/administração & dosagem , Músculos do Dorso/inervação , Dor nas Costas/prevenção & controle , Levobupivacaína/administração & dosagem , Vértebras Lombares/cirurgia , Morfina/administração & dosagem , Bloqueio Nervoso/métodos , Dor Pós-Operatória/prevenção & controle , Fusão Vertebral/efeitos adversos , Adolescente , Adulto , Idoso , Analgésicos Opioides/efeitos adversos , Anestésicos Locais/efeitos adversos , Dor nas Costas/diagnóstico , Dor nas Costas/etiologia , Dor nas Costas/fisiopatologia , Bélgica , Método Duplo-Cego , Feminino , Humanos , Levobupivacaína/efeitos adversos , Masculino , Pessoa de Meia-Idade , Morfina/efeitos adversos , Estudos Multicêntricos como Assunto , Bloqueio Nervoso/efeitos adversos , Medição da Dor , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/fisiopatologia , Ensaios Clínicos Pragmáticos como Assunto , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
13.
Trials ; 20(1): 457, 2019 Jul 26.
Artigo em Inglês | MEDLINE | ID: mdl-31349850

RESUMO

BACKGROUND: South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motivational interviewing (MI) techniques or use of short message service (SMS) text messaging. There have been no studies assessing the effect of combined MI and SMS interventions on multiple lifestyle factors and TB treatment outcomes. METHODS: This is a prospective, multicentre, two-arm individual randomised controlled trial looking at the effectiveness and cost-effectiveness of a complex behavioural intervention (the ProLife programme) on improving TB and lifestyle-related outcomes in three provinces of South Africa. The ProLife programme consists of an MI counselling strategy, delivered by lay health workers, augmented with subsequent SMS. We aim to recruit 696 adult participants (aged 18 years and over) with drug-sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use. Patients will be consecutively enrolled at 27 clinics in three different health districts in South Africa. Participants randomised individually to the intervention arm will receive three MI counselling sessions one month apart. Each MI session will be followed by twice-weekly SMS messages targeting treatment adherence, alcohol use and tobacco smoking, as appropriate. We will assess the effect on TB treatment success, using standard World Health Organization (WHO) treatment outcome definitions (primary outcome), as well as on a range of secondary outcomes including smoking cessation, reduction in alcohol use, and TB medication and anti-retroviral therapy adherence. Secondary outcomes will be measured at the three-month and six-month follow-ups. DISCUSSION: This trial aligns with the WHO agenda of integrating TB care with the care for chronic diseases of lifestyle, such as provision of smoking cessation treatments, and with the use of digital technologies. If the ProLife programme is found to be effective and cost-effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN62728852. Registered on 13 April 2018.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Antituberculosos/uso terapêutico , Comportamentos Relacionados com a Saúde , Entrevista Motivacional , Comportamento de Redução do Risco , Mensagem de Texto , Tuberculose/tratamento farmacológico , Consumo de Bebidas Alcoólicas/efeitos adversos , Consumo de Bebidas Alcoólicas/prevenção & controle , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Adesão à Medicação , Estudos Multicêntricos como Assunto , Ensaios Clínicos Pragmáticos como Assunto , Estudos Prospectivos , Abandono do Hábito de Fumar , África do Sul , Fatores de Tempo , Resultado do Tratamento , Tuberculose/diagnóstico , Tuberculose/microbiologia , Tuberculose/psicologia
14.
BMC Musculoskelet Disord ; 20(1): 342, 2019 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-31351449

RESUMO

BACKGROUND: Knee osteoarthritis (OA) is a prevalent and chronic condition with no known cure. Exercise is advocated in all clinical guidelines due to its positive effects on symptoms. Despite this, exercise participation is often poor in people with knee OA with access to exercise treatments a known barrier. Internet-delivered exercise interventions have the potential to improve access to evidence-based exercise treatments and can benefit OA outcomes, although non-usage and low adherence potentially limit their effectiveness. Short message services (SMS) show promise in facilitating exercise adherence and may be one solution to improve adherence to internet-delivered exercise interventions. The combination of internet-delivered exercise and SMS adherence support has not been specifically evaluated in people with knee OA. METHODS: This protocol reports a two-arm parallel-design, assessor- and participant-blinded randomised controlled trial. This trial is recruiting 206 people aged 45 years and older, with a clinical diagnosis of knee OA from the Australian-wide community. Eligible and consenting participants are enrolled and randomised to receive access to either i) 'My Knee Education', an education control website containing OA and exercise information only or ii) a combined intervention that includes a website, 'My Knee Exercise', containing the same educational information as the control, guidance to increase general physical activity, and the prescription of a 24-week self-directed home-based lower-limb strengthening program in addition to a 24-week behaviour change SMS exercise adherence program. Outcome measures are being collected at baseline and 24-weeks. Primary outcomes are self-reported knee pain and physical function. Secondary outcomes include another self-reported measure of knee pain, function in sport and recreation, quality-of-life, physical activity, self-efficacy, participant satisfaction and perceived global change. DISCUSSION: This randomised controlled trial will provide evidence about the effectiveness of a combined intervention of internet-delivered OA and exercise education, physical activity guidance and prescription of a 24-week lower-limb strengthening exercise program supported by a behaviour change SMS program compared to internet delivered OA and exercise education alone. TRIAL REGISTRATION: ACTRN12618001167257/13th July 2018.


Assuntos
Artralgia/terapia , Terapia Comportamental/métodos , Osteoartrite do Joelho/terapia , Educação de Pacientes como Assunto/métodos , Treinamento de Resistência/métodos , Artralgia/diagnóstico , Artralgia/etiologia , Austrália , Terapia Combinada , Medicina Baseada em Evidências , Feminino , Humanos , Internet , Articulação do Joelho/fisiopatologia , Extremidade Inferior/fisiopatologia , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/complicações , Osteoartrite do Joelho/fisiopatologia , Medição da Dor , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Ensaios Clínicos Pragmáticos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Autorrelato/estatística & dados numéricos , Telemedicina , Mensagem de Texto , Resultado do Tratamento
15.
Trials ; 20(1): 463, 2019 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-31358032

RESUMO

BACKGROUND: Differentiating infection from inflammation in acute pancreatitis is difficult, leading to overuse of antibiotics. Procalcitonin (PCT) measurement is a means of distinguishing infection from inflammation as levels rise rapidly in response to a pro-inflammatory stimulus of bacterial origin and normally fall after successful treatment. Algorithms based on PCT measurement can differentiate bacterial sepsis from a systemic inflammatory response. The PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP) trial tests the hypothesis that a PCT-based algorithm to guide initiation, continuation and discontinuation of antibiotics will lead to reduced antibiotic use in patients with acute pancreatitis and without an adverse effect on outcome. METHODS: This is a single-centre, randomised, controlled, single-blind, two-arm pragmatic clinical and cost-effectiveness trial. Patients with a clinical diagnosis of acute pancreatitis will be allocated on a 1:1 basis to intervention or standard care. Intervention will involve the use of a PCT-based algorithm to guide antibiotic use. The primary outcome measure will be the binary outcome of antibiotic use during index admission. Secondary outcome measures include: safety non-inferiority endpoint all-cause mortality; days of antibiotic use; clinical infections; new isolates of multiresistant bacteria; duration of inpatient stay; episode-related mortality and cause; quality of life (EuroQol EQ-5D); and cost analysis. A 20% absolute change in antibiotic use would be a clinically important difference. A study with 80% power and 5% significance (two-sided) would require 97 patients in each arm (194 patients in total): the study will aim to recruit 200 patients. Analysis will follow intention-to-treat principles. DISCUSSION: When complete, PROCAP will be the largest randomised trial of the use of a PCT algorithm to guide initiation, continuation and cessation of antibiotics in acute pancreatitis. PROCAP is the only randomised trial to date to compare standard care of acute pancreatitis as defined by the International Association of Pancreatology/American Pancreatic Association guidelines to patients having standard care but with all antibiotic prescribing decisions based on PCT measurement. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number, ISRCTN50584992. Registered on 7 February 2018.


Assuntos
Algoritmos , Antibacterianos/uso terapêutico , Técnicas de Apoio para a Decisão , Monitoramento de Medicamentos/métodos , Pancreatite/tratamento farmacológico , Pró-Calcitonina/sangue , Antibacterianos/efeitos adversos , Antibacterianos/economia , Biomarcadores/sangue , Tomada de Decisão Clínica , Ensaios Clínicos Fase III como Assunto , Redução de Custos , Análise Custo-Benefício , Custos de Medicamentos , Monitoramento de Medicamentos/economia , Inglaterra , Humanos , Pancreatite/sangue , Pancreatite/diagnóstico , Pancreatite/economia , Ensaios Clínicos Pragmáticos como Assunto , Valor Preditivo dos Testes , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento
16.
Trials ; 20(1): 426, 2019 Jul 12.
Artigo em Inglês | MEDLINE | ID: mdl-31300028

RESUMO

BACKGROUND: Adherence to tuberculosis (TB) treatment is challenging because of many factors. The World Health Organization has recommended the use of digital adherence monitoring technologies in its End TB Strategy. However, evidence on improving adherence is limited. EvriMED is a real-time medication-monitoring device which was found to be feasible and acceptable in a few studies in Asia. In Tanzania, however, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy, and cost effectiveness, which may have implications for treatment outcome. We propose a pragmatic cluster randomized trial to investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania. METHODS/DESIGN: We will create clusters in Kilimanjaro based on level of health care facility. Clusters will be randomized in an intervention arm, where evriMED will be implemented, or a control arm, where standard practice directly observed treatment will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the 'Stages of Change' model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action, and evaluation to change behavior for tailored feedback on adherence reports from the device. DISCUSSION: If the intervention shows a significant effect on adherence and the devices are accepted, accurate, and sustainable, the intervention can be scaled up within the National Tuberculosis Programmes. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR201811755733759 . Registered on 8 November 2018.


Assuntos
Antituberculosos/uso terapêutico , Retroalimentação Psicológica , Adesão à Medicação , Sistemas de Alerta , Mensagem de Texto , Tuberculose/tratamento farmacológico , Adolescente , Adulto , Idoso , Sinais (Psicologia) , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ensaios Clínicos Pragmáticos como Assunto , Tanzânia , Fatores de Tempo , Resultado do Tratamento , Tuberculose/diagnóstico , Tuberculose/psicologia , Adulto Jovem
17.
Nutrients ; 11(6)2019 Jun 19.
Artigo em Inglês | MEDLINE | ID: mdl-31248113

RESUMO

This study investigated associations between cardiovascular health (CVH), adiposity, and food insecurity by race, sex, and health literacy in a sample of 800 underserved patients with obesity (body mass index [BMI] ≥ 30 kg/m2). CVH was assessed using American Heart Association Life's Simple 7 (LS7) and adiposity was estimated using BMI and waist circumference (WC). Mixed models including interaction terms between food insecurity and sex, race, and health literacy were analyzed for LS7, BMI, and WC. Stratified models were analyzed as indicated by significant interactions. Mean BMI and WC were 37.3 kg/m2 (4.6 SD) and 113.5 cm (12.4 SD), respectively. Among patients, 31% were food insecure and 31% had low health literacy. There were significant positive associations between food insecurity and BMI (p = 0.03) and WC (p = 0.03) in the overall sample. In sex-stratified models, women who were food insecure had higher BMI (p = 0.02) and WC (p = 0.007) than their food secure counterparts. Further, food insecure patients with better health literacy had greater BMI (p = 0.004) and WC (p = 0.007) than their food secure counterparts. Results suggest that adiposity is a greater burden in food insecure patients, which may be an important consideration for obesity treatment in underserved populations.


Assuntos
Adiposidade/etnologia , Doenças Cardiovasculares/etnologia , Doenças Cardiovasculares/fisiopatologia , Abastecimento de Alimentos , Área Carente de Assistência Médica , Obesidade/etnologia , Obesidade/fisiopatologia , Determinantes Sociais da Saúde/etnologia , Populações Vulneráveis , Adulto , Índice de Massa Corporal , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/prevenção & controle , Estudos Transversais , Alfabetização em Saúde , Humanos , Louisiana/epidemiologia , Pessoa de Meia-Idade , Estado Nutricional/etnologia , Obesidade/diagnóstico , Obesidade/terapia , Ensaios Clínicos Pragmáticos como Assunto , Fatores de Risco , Fatores Sexuais , Circunferência da Cintura
18.
Trials ; 20(1): 307, 2019 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-31146778

RESUMO

BACKGROUND: Improving efficiencies in clinical research is crucial to translation of findings into practice and delivery of effective, patient-centered health care. This paper describes a project that monitored pragmatic clinical trials by working with investigators to track achievement of early phase milestones. The National Institutes of Health (NIH) Pragmatic Trials Collaborative Project supported scientifically diverse, low-cost, randomized, controlled, pragmatic clinical intervention trials. Funds were available through a cooperative agreement award mechanism, with the initial phase supporting trial planning and the subsequent 4-year awards funding trial implementation. A coordinating center provided evaluation and administrative support, which included capturing progress toward achieving milestones. METHODS: Six funded trials participated in monthly calls throughout the first year to identify and demonstrate metrics and deliverables for each milestone in the Notice of Grant Award. Interviews were conducted with investigators, trial team members, and NIH program officers/project scientists to discuss their perceptions of the impact and value of the management strategy. RESULTS: Five of six trials transitioned to the implementation phase with milestones ranging from 6 to 15 and quantifiable metrics ranging from 15 to 33, for a total of 121 deliverables. One third of the metrics (42, 35%) were trial-specific. Trial teams reported that the oversight was onerous but complemented their management strategies; program officers/project scientists found that documentation submitted for review was sufficient to assess trial feasibility; and investigators reported advantages to the phased award mechanism, such as leverage to secure commitments from stakeholders and collaborators, help with task prioritization, and earlier consultation with key members of the trial team. CONCLUSIONS: Implementing systematic approaches to identify milestones and track metrics can strengthen the evidence base regarding time and effort to plan and conduct pragmatic clinical trials. Investigators were unaccustomed to producing evidence of performance, and it was challenging to determine what documentation to provide. Efforts to standardize expectations regarding milestones that mark a significant change or stage in trial development or that represent minimum success criteria may provide guidance for more effective and efficient trial management. A framework with clearly specified metrics is especially critical for transparency, particularly when funding decisions are contingent on both merit and feasibility.


Assuntos
Ensaios Clínicos Pragmáticos como Assunto , Projetos de Pesquisa , Distinções e Prêmios , Humanos , National Institutes of Health (U.S.) , Ensaios Clínicos Pragmáticos como Assunto/economia , Estados Unidos
19.
Trials ; 20(1): 261, 2019 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-31068223

RESUMO

BACKGROUND: Data from a feasibility study suggest that the use of an inelastic, short-stretch compression bandage following total knee arthroplasty is a safe technique that may improve patient-reported health outcomes, and that it is feasible to recruit to a full-scale study. METHODS: We will conduct a randomised controlled trial (RCT) of 2600 adult patients, which has 80% power to detect a 1 point difference in the Oxford Knee Score (a patient self-reported assessment of knee pain and function) at 52 weeks. Short stretch compression bandaging will be compared with standard wool and crepe bandaging following total knee arthroplasty. Recruitment will take place in orthopaedic units across the United Kingdom. Secondary outcomes include the EuroQol 5 Dimensions (EQ-5D)-5 L and EQ-5D-3 L scores, pain, length of hospital stay, and complications. DISCUSSION: The Knee Replacement Bandaging Study (KReBS) is a large study which aims to contribute to the evidence base for informing clinical decisions for the use of compression bandaging following knee arthroplasty. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Register, ISRCTN 87127065 . Registered on 20 February 2017.


Assuntos
Artroplastia do Joelho/reabilitação , Bandagens Compressivas , Articulação do Joelho/cirurgia , Artroplastia do Joelho/efeitos adversos , Fenômenos Biomecânicos , Humanos , Articulação do Joelho/fisiopatologia , Estudos Multicêntricos como Assunto , Ensaios Clínicos Pragmáticos como Assunto , Recuperação de Função Fisiológica , Fatores de Tempo , Resultado do Tratamento , Reino Unido
20.
Trials ; 20(1): 255, 2019 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-31053082

RESUMO

BACKGROUND: Hypotension is associated with serious complications, including myocardial infarction, acute kidney injury, and mortality. Consequently, predicting and preventing hypotension may improve outcomes. We will therefore determine if use of a novel hypotension prediction tool reduces the duration and severity of hypotension in patients having non-cardiac surgery. METHODS/DESIGN: We will conduct a two-center, pragmatic, randomized controlled trial (N = 213) in noncardiac surgical patients > 45 years old who require intra-arterial blood pressure monitoring. All participating patients will be connected to a Flortrac IQ sensor and EV1000 platform (Edwards Lifesciences, Irvine). They will be randomly assigned to blinded or unblinded arms. The Hypotension Prediction Index (HPI) and advanced hemodynamic information will be universally recorded, but will only be available to clinicians when patients are assigned to unblinded monitoring. The primary outcome will be the effect of HPI software guidance on intraoperative time-weighted average mean arterial pressure under a threshold of 65 mmHg, which will be assessed with a Wilcoxon-Mann-Whitney 2-sample, two-tailed test. DISCUSSION: Our trial will determine whether the Hypotension Prediction Index and associated hemodynamic information substantively reduces hypotension during non-cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03610165 . Registered on 1 August 2018.


Assuntos
Pressão Arterial , Determinação da Pressão Arterial , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Hipotensão/prevenção & controle , Monitorização Intraoperatória/métodos , Software , Feminino , Humanos , Hipotensão/diagnóstico , Hipotensão/etiologia , Hipotensão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ohio , Ensaios Clínicos Pragmáticos como Assunto , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
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