Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators

Alterações no sono e na vigília repercutem negativamente no estado de humor, na memória e no desempenho psicomotor do indivíduo, refletindo diretamente em sua qualidade de vida. Instrumentos de avaliação da qualidade desses fatores devem estar disponíveis para a avaliação clínica. O objetivo deste trabalho foi traduzir e adaptar culturalmente os domínios Distúrbios do Sono e Distúrbios da Vigília do instrumento de medida Patient-Reported Outcomes Measurement Information System (PROMIS) para a língua portuguesa. O processo de tradução e adaptação transcultural seguiu as orientações da organização Functional Assessment of Chronic Illness Therapy (FACIT). Essa metodologia compreende: tradução, reconciliação, retrotradução, revisão dos autores e dos revisores independentes, pré- teste e obtenção da versão final em português. A versão para a língua portuguesa dos domínios Distúrbios do Sono e Distúrbios da Vigília do PROMIS apresentou boa equivalência semântica, idiomática, cultural e conceitual dos itens.

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The Pattern of Musculoskeletal Complaints in Patients with Suspected Psoriatic Arthritis and Their Correlation with Physical Examination and Ultrasound

The Journal of Rheumatology ◽

10.3899/jrheum.190857 ◽

2020 ◽

pp. jrheum.190857

Author(s):

Samantha Sarabia ◽

Chandra Farrer ◽

Jensen Yeung ◽

Dana Jerome ◽

Ker-Ai Lee ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Chronic Illness ◽

Physical Examination ◽

Functional Assessment ◽

Patient Reported Outcomes ◽

Advanced Practice ◽

Musculoskeletal Complaints ◽

Chronic Illness Therapy ◽

Patient Reported

Objective To describe the pattern of musculoskeletal (MSK) symptoms and their correlation with clinical and sonographic findings among psoriasis patients with suspected psoriatic arthritis (PsA). Methods Patients with psoriasis and no prior diagnosis of PsA were referred for assessment of their MSK complaints. The study included the following steps: (1) assessment by an advanced practice physiotherapist, (2) targeted MSK ultrasound, and (3) assessment by a rheumatologist. In addition, patients were asked to complete questionnaires about the nature and duration of their MSK symptoms and to mark the location of their painful joints on a homunculus. Each patient was classified by a rheumatologist as “Not PsA,” “Possible PsA,” or “PsA”. MSK symptoms and patient-reported outcomes (PRO) were compared between patients with PsA and Possible/Not PsA. Agreement between modalities was assessed using κ statistics. Results Two hundred three patients with psoriasis and MK symptoms were enrolled (8.8% PsA, 23.6% Possible PsA). Patients classified as PsA had worse scores on the PsA Impact of Disease (P = 0.004) and Functional Assessment of Chronic Illness Therapy–Fatigue scale (P = 0.02). There was no difference between the 2 groups in the presence, distribution, and duration of MSK symptoms. Analysis of agreement in physical examination between modalities revealed the strongest agreement between the rheumatologist and physiotherapist (κ = 0.28). The lowest levels of agreement were found between ultrasound and patient (κ = 0.08) and physiotherapist and ultrasound (κ = 0.08). Conclusion The results of this study suggest that the intensity, rather than the type, duration, or distribution of MSK symptoms, is associated with PsA among patients with psoriasis.

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Adaptação transcultural e validação da escala de Saúde Global do PROMIS para a língua portuguesa

Cadernos de Saúde Pública ◽

10.1590/0102-311x00107616 ◽

2017 ◽

Vol 33 (1) ◽

Author(s):

Camila Eugênia Zumpano ◽

◽

Tânia Maria da Silva Mendonça ◽

Carlos Henrique Martins da Silva ◽

Helena Correia ◽

...

Keyword(s):

Information System ◽

Chronic Illness ◽

Functional Assessment ◽

Patient Reported Outcomes ◽

Measurement Information ◽

Outcomes Measurement ◽

Chronic Illness Therapy ◽

Patient Reported ◽

Measurement Information System

Resumo: O objetivo deste estudo foi realizar a adaptação transcultural da escala de Saúde Global do Patient-Reported Outcomes Measurement Information System (PROMIS) para a língua portuguesa. Os dez itens sobre Saúde Global foram adaptados transculturalmente por meio do método proposto pelo Functional Assessment of Chronic Illness Therapy (FACIT). A versão final do instrumento para a língua portuguesa foi autoadministrada em 1.010 participantes no Brasil. A precisão da escala foi verificada usando-se a análise dos efeitos piso e teto, confiabilidade da consistência interna e confiabilidade teste-reteste. Utilizou-se a análise fatorial exploratória e confirmatória para avaliação da validade de construto e dimensionalidade do instrumento. A calibração dos itens foi realizada por meio do Modelo de Resposta Gradual proposto por Samejima. Quatro itens globais necessitaram de ajustes após a realização do pré-teste. A análise das propriedades psicométricas demonstrou que a escala de Saúde Global tem boa confiabilidade, com coeficiente alfa de Cronbach de 0,83 e coeficiente de correlação intraclasse de 0,89. As análises fatorial exploratória e confirmatória revelaram um bom ajuste ao modelo previamente estabelecido de duas dimensões. As escalas de Saúde Física Global e Saúde Mental Global apresentaram uma boa cobertura do traço latente, de acordo com o Modelo de Resposta Gradual. Os itens Saúde Global do PROMIS para a língua portuguesa apresentaram equivalência em relação à versão original e propriedades psicométricas satisfatórias para a aplicação direcionada à população brasileira na prática clínica e em pesquisas.

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Functional Assessment of Chronic Illness Therapy--Spiritual Personal Well-being; Czech Version

PsycTESTS Dataset ◽

10.1037/t71728-000 ◽

2018 ◽

Author(s):

Gabriela Šarníková ◽

Klára Maliňáková ◽

Jana Fürstová ◽

Eva Dubovská ◽

Peter Tavel

Keyword(s):

Chronic Illness ◽

Functional Assessment ◽

Well Being ◽

Chronic Illness Therapy

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Functional Assessment of Chronic Illness Therapy Measurement System

PsycTESTS Dataset ◽

10.1037/t77273-000 ◽

2003 ◽

Author(s):

Kimberly Webster ◽

David Cella ◽

Kathleen Yost

Keyword(s):

Chronic Illness ◽

Measurement System ◽

Functional Assessment ◽

Chronic Illness Therapy

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Longitudinal Trajectory of Fatigue in Patients With Inflammatory Bowel Disease: A Prospective Study

Inflammatory Bowel Diseases ◽

10.1093/ibd/izaa338 ◽

2020 ◽

Author(s):

Nienke Z Borren ◽

Millie D Long ◽

Robert S Sandler ◽

Ashwin N Ananthakrishnan

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Chronic Illness ◽

Prospective Study ◽

Functional Assessment ◽

Bowel Disease ◽

Symptom Resolution ◽

Chronic Illness Therapy ◽

Inflammatory Bowel ◽

A Prospective Study

Abstract Background Fatigue is a disabling symptom in patients with inflammatory bowel disease (IBD). Its prevalence, mechanism, and impact remain poorly understood. We determined changes in fatigue status over time and identified predictors of incident or resolving fatigue. Methods This was a prospective study nested within the IBD Partners cohort. Participants prospectively completed the Multidimensional Fatigue Inventory and the Functional Assessment of Chronic Illness Therapy-Fatigue at baseline, 6 months, and 12 months. A Functional Assessment of Chronic Illness Therapy-Fatigue score ≤43 defined significant fatigue. Multivariable regression models using baseline covariates were used to identify risk factors for incident fatigue at 6 months and to predict the resolution of fatigue. Results A total of 2429 patients (1605 with Crohn disease, 824 with ulcerative colitis) completed a baseline assessment, and 1057 completed a second assessment at 6 months. Persistent fatigue (at baseline and at 6 months) was the most common pattern, affecting two-thirds (65.8%) of patients. One-sixth (15.7%) of patients had fatigue at 1 timepoint, whereas fewer than one-fifth (18.5%) of patients never reported fatigue. Among patients not fatigued at baseline, 26% developed fatigue at 6 months. The strongest predictor of incident fatigue was sleep disturbance at baseline (odds ratio, 2.91; 95% confidence interval, 1.48–5.72). In contrast, only 12.3% of those with fatigue at baseline had symptom resolution by month 6. Resolution was more likely in patients with a diagnosis of ulcerative colitis, quiescent disease, and an absence of significant psychological comorbidity. Conclusions Fatigue is common in patients with IBD. However, only a few fatigued patients experience symptom resolution at 6 or 12 months, suggesting the need for novel interventions to ameliorate its impact.

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Electronic patient-reported outcomes and machine learning in predicting immune-related adverse events of immune checkpoint inhibitor therapies

BMC Medical Informatics and Decision Making ◽

10.1186/s12911-021-01564-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Sanna Iivanainen ◽

Jussi Ekstrom ◽

Henri Virtanen ◽

Vesa V. Kataja ◽

Jussi P. Koivunen

Keyword(s):

Machine Learning ◽

Early Detection ◽

Adverse Events ◽

Cancer Patients ◽

Immune Checkpoint ◽

Patient Reported Outcomes ◽

Prediction Models ◽

Accuracy Score ◽

Patient Reported ◽

Auc Value

Abstract Background Immune-checkpoint inhibitors (ICIs) have introduced novel immune-related adverse events (irAEs), arising from various organ systems without strong timely dependency on therapy dosing. Early detection of irAEs could result in improved toxicity profile and quality of life. Symptom data collected by electronic (e) patient-reported outcomes (PRO) could be used as an input for machine learning (ML) based prediction models for the early detection of irAEs. Methods The utilized dataset consisted of two data sources. The first dataset consisted of 820 completed symptom questionnaires from 34 ICI treated advanced cancer patients, including 18 monitored symptoms collected using the Kaiku Health digital platform. The second dataset included prospectively collected irAE data, Common Terminology Criteria for Adverse Events (CTCAE) class, and the severity of 26 irAEs. The ML models were built using extreme gradient boosting algorithms. The first model was trained to detect the presence and the second the onset of irAEs. Results The model trained to predict the presence of irAEs had an excellent performance based on four metrics: accuracy score 0.97, Area Under the Curve (AUC) value 0.99, F1-score 0.94 and Matthew’s correlation coefficient (MCC) 0.92. The prediction of the irAE onset was more difficult with accuracy score 0.96, AUC value 0.93, F1-score 0.66 and MCC 0.64 but the model performance was still at a good level. Conclusion The current study suggests that ML based prediction models, using ePRO data as an input, can predict the presence and onset of irAEs with a high accuracy, indicating that ePRO follow-up with ML algorithms could facilitate the detection of irAEs in ICI-treated cancer patients. The results should be validated with a larger dataset. Trial registration Clinical Trials Register (NCT3928938), registration date the 26th of April, 2019

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