Which Scale to Assess Pain Self-efficacy Shows Better Measurement Properties in Chronic Low Back Pain? A Head-To-Head Comparison Study.

OBJECTIVE: To compare the quality of the measurement properties of Pain Self-Efficacy Questionnaire (PSEQ)-10, PSEQ-4, PSEQ-2, Chronic Pain Self-Efficacy Scale (CPSS) long-form, and CPSS short-form (CPSS-SF) in patients with chronic low back pain (CLBP). DESIGN: Cross-sectional and longitudinal studies (measurement properties). SETTING: Outpatient rehabilitation. PARTICIPANTS: Participants (N=245) with nonspecific CLBP (18-60y, 63% women) were enrolled in this study. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Pain self-efficacy questionnaires were administered on 3 occasions: baseline assessment, 1 week after the first assessment (reliability), and after an 8-week exercise program (responsiveness). The intraclass correlation coefficient (ICC) and Cronbach α were used to assess reliability and internal consistency, respectively. Pearson correlation and confirmatory factor analyses were used to assess construct validity. The area under the curve and hypothesis testing were used to assess responsiveness. RESULTS: No difference was observed for all the questionnaires regarding internal consistency (Cronbach α>.7), criterion validity (r>.88), and reliability (ICC>.7). The scales confirmed >75% of the hypotheses for the construct validity, except for CPSS-SF. PSEQ-2 did not meet the criterion for structural validity. PSEQ-10 met all the criteria for good measurement properties according to Consensus-Based Standards for the Selection of Health Measurement Instruments. CONCLUSIONS: It was not possible to calculate structural validity for PSEQ-2, CPSS-SF did not meet the criterion for suitable hypothesis testing for construct validity, and all the questionnaires did not show suitable measurement error, except for the PSEQ-10. Hence, the PSEQ-10 was the unique scale that met all the criteria for good measurement properties for assessing pain self-efficacy in CLBP.

Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial.

INTRODUCTION: Placebo effects are responses capable of modulating pain and influencing treatment response. Two mechanisms are commonly related to placebo effects: expectations and conditioning. However, the research in this field is focused on laboratory studies with healthy participants. This study aims to identify whether a conditioning procedure with positive induced expectations about spinal manipulative therapy (SMT) will result in greater hypoalgesic effects in adults with chronic low back pain (CLBP) in a clinical trial design. METHODS AND ANALYSIS: This trial will enrol 264 patients with non-specific CLBP, aged 18-60 years. Patients will undergo a calibration test to determine the thermal pain threshold for the hidden pain conditioning procedure. Afterward, they will be randomised to one of the three groups: hidden pain conditioning with positive induced expectations-group one (G1); positive expectations-group two (G2) and neutral expectations-group three (G3). Patients will receive instructions to manipulate the expectations. The pretreatment heat pain test will be performed before the SMT and after the intervention patients will undergo again the heat pain intensity test. However, only patients in G1 will receive hidden pain conditioning to reinforce the association between SMT and pain intensity reduction. All patients will undergo five sessions of SMT. The outcomes will be assessed immediately after the last session and at the 6 weeks and 3-month follow-ups. All statistical analyses will be conducted following intention-to-treat principles, and the treatment effects will be determined with linear mixed models. ETHICS AND DISSEMINATION: The Federal University of São Carlos approved this research (Process n° 52359521.1.0000.5504). All participants will give written informed consent. Dissemination of the results will include publications in peer-reviewed journals and presentations at conferences. If positive expectations and classical conditioning improve outcomes, it may support the administration of such intervention. TRIAL REGISTRATION NUMBER: NCT05202704.

How to determine the quality of a questionnaire according to the CONsensus-based Standards for the selection of health Measurement INstruments? A simplified guide to the measurement properties of assessment instruments - Part II: validity, responsiveness, interpretability and a checklist for characterizing the quality of instruments / Como determinar a qualidade de um questionário de acordo com o COnsensus-based Standards for the selection of health Measurement INstruments? Um guia simplificado sobre as propriedades de medida de instrumentos de avaliação - Parte II: validade, responsividade, interpretabilidade e checklist para caracterização da qualidade dos instrumentos

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 study (part II) were: (I) to introduce basic concepts about PROMs with a focus on the terminology and criteria defined by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and (2) to describe the measurement properties of the validity, responsiveness and interpretability domains and propose a checklist for assessing the quality of PROMs' measurement properties. METHODS: This study was produced using a search for articles from the COSMIN initiative. For didactic purposes, the text was divided into two parts. RESULTS: This article included a description of the measurement properties of the validity (content, structural, construct), responsiveness (must be assessed through accuracy analyses, AUC≥0.70) and interpretability (which provides the minimum clinically important change) domains. In addition, a checklist was proposed for determining the quality of the measurement properties of assessment instruments. CONCLUSION: This study described the measurement properties within the validity and responsiveness domains, and the importance of interpretability for obtaining the minimum clinically important difference. The proposed checklist for evaluating these properties can help clinicians and researchers to determine the quality of an instrument and make a decision about the best option available.

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 tomada de 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 II) 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 dos domínios validade, responsividade e interpretabilidade e propor um checklist para avaliação da qualidade das propriedades de medida de PROMs. MÉTODOS: Utilizando uma busca voltada para os artigos da iniciativa COSMIN, foi elaborado o presente estudo de revisão, que foi dividido em duas partes para fins didáticos. RESULTADOS: O presente artigo compreendeu a descrição das propriedades de medida dos domínios de validade (conteúdo, estrutural, construto), responsividade (deve ser avaliada através de análises de acurácia, AUC≥0,70) e interpretabilidade (que fornece a mínima mudança clinicamente importante). Além disso, foi proposto um checklist para determinação da qualidade das propriedades de medida de instrumentos de avaliação. CONCLUSÃO: Este estudo descreveu as propriedades de medida dentro dos domínios validade e responsividade, e a importância da interpretabilidade para a obtenção da mínima diferença clinicamente importante. O checklist proposto para avaliação dessas propriedades pode auxiliar clínicos e pesquisadores a determinarem a qualidade de um instrumento e tomar a decisão sobre a melhor opção disponível.

How to determine the quality of a questionnaire according to the CONsensus-based Standards for the selection of health Measurement INstruments? A simplified guide to the measurement properties of assessment instruments - Part I: basic concepts and reliability / Como determinar a qualidade de um questionário de acordo com o CONsensus-based Standards for the selection of health Measurement INstruments? Um guia simplificado sobre as propriedades de medida de instrumentos de avaliação - Parte I: conceitos básicos e confiabilidade

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.