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1.
BrJP ; 6(4): 410-417, Oct.-Dec. 2023. graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1527984

RESUMO

ABSTRACT BACKGROUND AND OBJECTIVES: The type of questionnaire that aims to capture a patient's perception/view of an aspect to be measured (e.g. pain intensity) is called Patient Reported Outcome Measure (PROM). One of the biggest challenges that clinicians and researchers often face is making a decision about which PROM to use for the assessment of their patient with pain, especially due to the lack of scientific literacy needed to understand the criteria and terms used in the field of measurement properties. Thus, the objectives of this narrative review (part I) were: (I) to introduce basic concepts about PROMs with a focus on the terminology and criteria defined through the COnsensus- based Standards for the selection of health Measurement INstruments (COSMIN), and (2) to describe the measurement properties of the reliability domain. METHODS: This study was produced using a search for articles from the COSMIN initiative. As the subject is very extensive, the authors divided the text into two parts. RESULTS: This study described basic concepts about PROMs (purposes and constructs), the process of cross-cultural adaptation and the measurement properties of the reliability domain (reliability, error measure and internal consistency). In general, an instrument with adequate reliability quality should meet certain criteria, such as: intraclass correlation coefficient ≥0.70, error measure < minimal clinically important change and Cronbach's Cronbach's α ≥ 0.70. CONCLUSION: The understanding on how to determine the quality of reliability can assist clinicians and researchers in choosing the best PROMs available. A checklist for assessing the quality of the measurement properties of PROMs is described in the part II of the manuscript.


RESUMO JUSTIFICATIVA E OBJETIVOS: O tipo de questionário que pretende captar a percepção/visão de um paciente sobre um aspecto a ser medido (ex: intensidade da dor) é chamado de Instrumento de Medida Baseado no Relato do Paciente (Patient Reported Outcome Measure - PROM). Um dos maiores desafios que clínicos e pesquisadores costumam enfrentar é quanto a tomar uma decisão sobre qual PROM utilizar para a avaliação de seu paciente com dor, especialmente devido à falta do letramento científico necessário para entender os critérios e termos empregados na área de propriedades de medida. Assim, os objetivos deste estudo (parte I) foram: (I) introduzir conceitos básicos sobre PROMs com enfoque na terminologia e critérios definidos através do COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), e (2) descrever as propriedades de medida do domínio confiabilidade. MÉTODOS: Utilizando uma busca voltada para os artigos da iniciativa COSMIN, foi elaborado este estudo. Sendo o assunto muito extenso, os autores dividiram o texto em duas partes. RESULTADOS: O presente artigo descreveu conceitos básicos sobre PROMs (propósitos e construtos), o processo de adaptação transcultural e as propriedades de medida do domínio confiabilidade (confiabilidade, medida de erro e consistência interna). De forma geral, um instrumento com qualidade adequada de confiabilidade deveria atender a alguns critérios, tais como: coeficiente de correlação intraclasse ≥ 0,70, medida de erro < mínima mudança clinicamente importante e α de Cronbach ≥ 0,70. CONCLUSÃO: O entendimento sobre como determinar a qualidade da propriedade de medida de confiabilidade pode auxiliar os clínicos e pesquisadores na escolha dos melhores PROMs disponíveis. Um checklist para avaliação da qualidade das propriedades de medida de PROMs está descrita na parte II do artigo.

2.
Trials ; 23(1): 544, 2022 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-35788240

RESUMO

BACKGROUND: Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy (CFT) is a promising new intervention that deals with potentially modifiable multidimensional aspects of pain (e.g., provocative cognitive, movement, and lifestyle behaviors). METHODS: To investigate the efficacy of CFT compared with a sham intervention for pain intensity and disability post-intervention (immediately after the last session) in patients with non-specific chronic low back pain (CLBP). This study is a randomized controlled trial in which 152 (18-60 years old) patients with CLBP will be enrolled. The patients will be randomly allocated to receive (1) CFT intervention or (2) sham intervention. The experimental group will receive individualized CFT in a pragmatic manner (5 to 7 sessions) based on the clinical progression of the participants. The sham group will attend six sessions: consisting of 30 min of photobiomodulation using a detuned device and more than 15 min of talking about neutral topics. Patients from both groups also will receive an educational booklet (for ethical reasons). Participants will be assessed pre and post-intervention, 3 months, and 6 months after randomization. The primary outcomes will be pain intensity and disability post-intervention. The secondary outcomes will be: pain intensity and disability at 3- and 6-month follow-up, as well as self-efficacy, global perceived effect of improvement, and functioning post-intervention, 3-, and 6-month follow-up. The patients and the assessor will be blinded to the treatment administered (active vs. sham). STATISTICAL ANALYSIS: The between-group differences (effects of treatment), as well as the treatment effect for the primary and secondary outcomes, and their respective 95% confidence intervals will be calculated by constructing linear mixed models. DISCUSSION: To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04518891 . First Posted: August 19, 2020.


Assuntos
Terapia Cognitivo-Comportamental , Dor Lombar , Adolescente , Adulto , Dor Crônica/terapia , Cognição , Terapia Cognitivo-Comportamental/métodos , Humanos , Dor Lombar/diagnóstico , Dor Lombar/terapia , Pessoa de Meia-Idade , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Adulto Jovem
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