Estimating the effects of patient-reported outcome (PRO) diarrhea and pain measures on PRO fatigue: Data analysis from a phase II study of abemaciclib monotherapy, a CDK4 and CDK6 inhibitor, in patients with HR+/HER2- breast cancer after chemotherapy for metastatic disease—MONARCH 1.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1060-1060 ◽  
Author(s):  
Mark Boye ◽  
Katherine Houghton ◽  
Donald E Stull ◽  
Claire Ainsworth ◽  
Gregory L Price
Keyword(s):  
Latent Variable ◽  
Structural Equation ◽  
Brief Pain Inventory ◽  
Patient Reported Outcome ◽  
Equation Model ◽  
Open Label ◽  
Cross Sectional ◽  
Her2 Breast Cancer ◽  
Patient Reported ◽  
Eortc Qlq

1060 Background: Investigators reporting treatment-emergent adverse events (TEAEs) in the 3rdline or greater abemaciclib MONARCH1 Phase 2 study observed Grade 1-3 diarrhea, fatigue, and abdominal pain in 90, 65, and 39% of the patients (n = 132). Unknown is the extent that diarrhea and overall pain add to fatigue in this setting. Using patient-reported outcome (PRO) measures, we conducted cross-sectional and longitudinal multivariate analyses to estimate these effects. Methods: Data came from a single-arm, open-label study of previously-treated patients with mBC. Throughout the study, the Brief Pain Inventory and the EORTC QLQ-C30 v3 were co-administered. All constructs and items from these two questionnaires –except EORTC Items 25 and 28 (memory and financial difficulties) - were used to estimate the Structural Equation Model (SEM) and the direct and indirect effects of pain and diarrhea on fatigue. Extended pattern mixture modeling (ePMM) – a latent variable modeling method that allows the explicit analysis of missing data and identifies subgroups with differential changes over time – was used to explore these relationships from screening through cycle 8. Results: SEM results showed that at cycle 2 of treatment, pain was a significant predictor of fatigue (b = 0.68; P < 0.001; CI 0.48 – 0.90); diarrhea was not a significant predictor of fatigue (b = 0.06; P = 0.12; CI -0.04 – 0.17). ePMM results across eight 30-day cycles found three fatigue subgroups: no change, improvement, worsening then improvement. Belonging to a similar pain subgroup predicted belonging to the corresponding fatigue subgroup (ref class was no change; improving b = 5.03, P = 0.004; worsening b = 22.01, P < 0.001); the same was not true for diarrhea and fatigue (ref class was no change; improving b = 0.213, P = 0.75; worsening b = 0.04, P = 0.97). Conclusions: These results suggest that for patients undergoing 3rd line or greater mBC treatment, pain is a significant predictor of fatigue early and over the course of the trial. However, diarrhea is not a significant predictor of fatigue. Clinical trial information: NCT02102490.

Patient-reported outcomes in PD-1/PD-L1 inhibitor registration trials: FDA analysis of data submitted and future directions.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 134-134 ◽  
Author(s):  
Lynn Jackson Howie ◽  
Harpreet Singh ◽  
Bellinda King-Kallimanis ◽  
Jessica Roydhouse ◽  
Marc Robert Theoret ◽  
...  
Keyword(s):  
Physical Function ◽  
Patient Experience ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Symptom Scale ◽  
Open Label ◽  
Benefit Risk Assessment ◽  
Patient Reported ◽  
Lung Cancer Symptom Scale ◽  
Eortc Qlq

134 Background: Patient-reported outcome measures (PROs) can capture the patient’s experience with disease and treatment. Anti-PD-1/PD-L1 therapies have unique symptomatic side effects; PRO data can help to better understand the patient experience on therapy. Health-related quality of life (HRQL) components most impacted by therapy include disease symptoms, symptomatic toxicity and physical function. Methods: We reviewed FDA registration trials for 5 immunotherapy agents (anti-PD-1/PD-L1) to evaluate trial design and PRO assessment. We assessed whether the PRO strategy assessed physical function and symptomatic immune-related adverse events (irAEs) by reviewing whether trials used a well-defined physical function domain and 8 symptoms related to irAEs reported in product labels (fatigue, diarrhea, cough, shortness of breath, musculoskeletal pain, rash, pruritis and fever). Results: Data from 25 trials across 7 disease types and 1 tumor agnostic indication were evaluated. Of these, 13 were randomized and 22 were open label. Eighteen of 25 contained PRO assessments and all 18 used > 1 instrument. The most common instruments were the EQ-5D (N = 17), followed by EORTC QLQ-C30 (N = 15). Disease-specific PRO tools were included in 8 trials (5 lung, 1 head and neck, 1 melanoma and 1 renal cell), consisting of modules or scales from EORTC (N = 5), FACIT (N = 2) or the Lung Cancer Symptom Scale (N = 1). Sixty percent of the trials (15/25) used an instrument that contained a well-defined physical function (PF) domain. No trial used a PRO strategy assessing all 8 selected symptoms related to irAEs. Conclusions: Collection of PRO data in anti-PD-1/PD-L1 trials submitted to FDA was variable, and did not consistently assess treatment related symptoms and physical function. Use of a HRQL tool with well-defined functional scales supplemented by item banks or libraries to incorporate symptoms associated with irAEs may improve understanding of the patient experience while receiving anti-PD-1/PD-L1 treatment. These data, along with other important clinical data such as hospitalizations, ER visits and supportive care medications can inform the benefit risk assessment for regulatory purposes.

scholarly journals A structural equation model of the family physicians attitude towards their role in prevention: a cross-sectional study in Switzerland

2018 ◽  
Vol 36 (3) ◽  
pp. 297-303 ◽  
Author(s):  
Christine Cohidon ◽  
Pascal Wild ◽  
Nicolas Senn
Keyword(s):  
Preventive Care ◽  
Latent Variable ◽  
Structural Equation ◽  
Quantitative Research ◽  
Dietary Habits ◽  
Family Physicians ◽  
Equation Model ◽  
Equation Modeling ◽  
Online Questionnaire ◽  
Cross Sectional

Abstract Background In contrast to many studies exploring barriers to preventive care in family medicine, there is less quantitative research regarding the self-perceived role of family physicians (FPs) in prevention and its predictive factors. Moreover, the existing studies considered this attitude as a homogeneous entity. The objective of this study is firstly, to characterize FPs’ attitudes towards prevention taking into account nine different prevention themes, and secondly, to explore the factors that could be predictive of this attitude. Methods The data stem from a cross-sectional national survey on prevention we conducted in Switzerland from 2015 to 2016 (170 physicians randomly drawn, online questionnaire). We first performed a confirmatory factor analysis to define a homogeneous latent variable regarding physicians’ attitude towards prevention, then, a structural equation modeling to identify potential predictors. Results The FP’ attitude towards their role in preventive care was homogeneously positive whatever the topic (smoking, drinking dietary habits, physical activities, and more generally, cardiovascular risk factors) except for occupational risks and cannabis consumption. A feeling of good effectiveness was a positive predictor of this positive attitude while seniority, the lack of reimbursement and being a physician from the German-speaking area were negative predictors. Conclusion The FP’ attitude about their role in prevention is homogeneous concerning the ‘classical’ topics of prevention, whereas they still under-recognize certain topics as important fields for prevention. To change this situation, we probably need a global effort to introduce other ways of thinking about prevention, including not only FP but also all stakeholders.

Upaya Preventif, Mutu, Kepuasan Dan Loyalitas Ibu Hamil Terhadap Minat Kunjungan Ulang di Klinik Abdi Persada Banjarmasin

2019 ◽  
Vol 2 (1) ◽  
pp. 69-84
Author(s):  
Nur Cahyani Ari Lestari
Keyword(s):  
Structural Equation Model ◽  
Structural Equation ◽  
Equation Model ◽  
Cross Sectional

Upaya preventif dalam kesehatan dan peningkatan mutu pelayanan merupakan salah satu ukuran dari kepuasan pasien dan loyalitas pasien yang mempengaruhi keinginan pasien untuk melakukan kunjungan ulang kembali terhadap penyedia jasa layanan kesehatan tersebut. Penelitian ini bertujuan untuk mengetahui pengaruh langsung maupun tidak langsung serta besaran antara upaya preventif, mutu pelayanan kepuasaan dan loyalitas ibu hamil terhadap minat kunjungan ulang ibu hamil di Klinik Abdi Persada Banjarmasin Tahun 2018. Penelitian ini, menggunakan metode cross sectional. Populasinya adalah ibu hamil yang memeriksakan kehamilannya di Klinik Abdi Persada Banjarmasin. Sampel penelitian ini berjumlah 90 orang ibu hamil. Penelitian ini menggunakan metode analisis Structural Equation Model menggunakan Smart PLS 2.0 dan SPSS 18. Hasil pengujian hipotesis dengan Structural Equation Model (SEM) dengan metode smartPLS menghasilkan temuan penelitian yaitu upaya preventif (24,56%), mutu pelayanan (26,89%), kepuasan (8,13%) dan loyalitas (38,33%). Loyalitas ibu hamil merupakan faktor dominan yang mempengaruhi minat kunjungan ulang ibu hamil di Klinik Abdi Persada Banjarmasin. Model - Model hasil analisis dapat menjelaskan 99,9% keragaman data dan mampu mengkaji fenomena yang dipakai dalam penelitian, sedangkan 0,1% dijelaskan komponen lain yang tidak ada dalam penelitian ini. Dapat disimpulkan bahwa terdapat pengaruh antara upaya preventif, mutu pelayanan, kepuasan dan loyalitas tehadap minat kunjungan ulang ibu hamil. Sarannya sebagai masukkan untuk lebih meningkatkan pelayanan kepada ibu hamil dalam pemeriksaan kehamilannya sehingga memberikan kepuasan ibu hamil agar dapat berkunjung kembali. Kata Kunci: Preventif, Mutu Pelayanan, Kepuasaan, Loyalitas, Kunjungan Ulang

An Explanatory Model of Problematic Internet Use of Southern Spanish University Students

2021 ◽  
pp. 089443932199865
Author(s):  
José-María Romero-Rodríguez ◽  
José-Antonio Marín-Marín ◽  
Francisco-Javier Hinojo-Lucena ◽  
Gerardo Gómez-García
Keyword(s):  
University Students ◽  
Undergraduate Students ◽  
Internet Addiction ◽  
Structural Equation ◽  
Internet Use ◽  
Sociodemographic Factors ◽  
Equation Model ◽  
Problematic Internet Use ◽  
Moderate Degree ◽  
Cross Sectional

The problematic Internet use (PIU) has become a topic of special relevance since it is a problem that affects the whole world. It has been detected that the population at greatest risk is university students along with adolescents. At the same time, Spain is one of the countries with the highest PIU rate. The purposes of this article were to analyze the presence and degree of Internet addiction among university students and to check the sociodemographic factors that influence the PIU. To this end, 13 hypotheses were put forward and contrasted using a structural equation model. The study adopted a cross-sectional approach by applying the Internet addiction test to a sample of undergraduate students in southern Spain ( n = 1,013). The results indicated a prevalence of PIU among students of almost 12.5% and with a moderate degree of addiction. In turn, the following hypotheses that had a significant effect on the PIU were supported: gender; field of knowledge; living in the parents’ home; Internet daily use for leisure; Internet daily use for academic purposes; number of social networks; sexual orientation; marital status. Finally, the main findings of the study were reviewed, and the main recommendations and implications for mitigating the negative effects of technology and enhancing the positive ones were established.

scholarly journals Assessing the Impact of Multi-Morbidity and Related Constructs on Patient Reported Safety in Primary Care: Generalized Structural Equation Modelling of Observational Data

2021 ◽  
Vol 10 (8) ◽  
pp. 1782
Author(s):  
Ignacio Ricci-Cabello ◽  
Aina María Yañez-Juan ◽  
Maria A. Fiol-deRoque ◽  
Alfonso Leiva ◽  
Joan Llobera Canaves ◽  
...  
Keyword(s):  
Primary Care ◽  
Patient Safety ◽  
Structural Equation ◽  
Structural Equation Models ◽  
Cross Sectional ◽  
Morbidity Burden ◽  
Patient Reported ◽  
Patient Complexity ◽  
Complex Relationships ◽  
The Impact

We aimed to examine the complex relationships between patient safety processes and outcomes and multimorbidity using a comprehensive set of constructs: multimorbidity, polypharmacy, discordant comorbidity (diseases not sharing either pathogenesis nor management), morbidity burden and patient complexity. We used cross-sectional data from 4782 patients in 69 primary care centres in Spain. We constructed generalized structural equation models to examine the associations between multimorbidity constructs and patient-reported patient safety (PREOS-PC questionnaire). These associations were modelled through direct and indirect (mediated by increased interactions with healthcare) pathways. For women, a consistent association between higher levels of the multimorbidity constructs and lower levels of patient safety was observed via either pathway. The findings for men replicated these observations for polypharmacy, morbidity burden and patient complexity via indirect pathways. However, direct pathways showed unexpected associations between higher levels of multimorbidity and better safety. The consistent association between multimorbidity constructs and worse patient safety among women makes it advisable to target this group for the development of interventions, with particular attention to the role of comorbidity discordance. Further research, particularly qualitative research, is needed for clarifying the complex associations among men.

Patient-Reported Outcome Measures in Colorectal Surgery: Construction of Core Measures Using Open-Source Research Method

2021 ◽  
pp. 155335062199887
Author(s):  
Alaa El-Hussuna ◽  
Ines Rubio-Perez ◽  
Monica Millan ◽  
Gianluca Pellino ◽  
Ionut Negoi ◽  
...  
Keyword(s):  
Colorectal Surgery ◽  
Outcome Measures ◽  
Short Form ◽  
Wide Spectrum ◽  
Core Outcome Set ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Eortc Qlq

Purpose. The primary aim of the study was to review the existing literature about patient-reported outcome measures (PROMs) in colorectal cancer and IBD. The secondary aim was to present a road map to develop a core outcome set via opinion gathering using social media. Method. This study is the first step of a three-step project aimed at constructing simple, applicable PROMs in colorectal surgery. This article was written in a collaborative manner with authors invited both through Twitter via the #OpenSourceResearch hashtag. The 5 most used PROMs were presented and discussed as slides/images on Twitter. Inputs from a wide spectrum of participants including researchers, surgeons, physicians, nurses, patients, and patients’ organizations were collected and analyzed. The final draft was emailed to all contributors and 6 patients’ representatives for proofreading and approval. Results. Five PROM sets were identified and discussed: EORTC QLQ-CR29, IBDQ short health questionnaire, EORTC QLQ-C30, ED-Q5-5L, and Short Form-36. There were 315 tweets posted by 50 tweeters with 1458 retweets. Awareness about PROMs was generally limited. The general psycho-physical well-being score (GPP) was suggested and discussed, and then a survey was conducted in which more than 2/3 of voters agreed that GPP covers the most important aspects in PROMs. Conclusion. Despite the limitations of this exploratory study, it offered a new method to conduct clinical research with opportunity to engage patients. The general psycho-physical well-being score suggested as simple, applicable PROMs to be eventually combined procedure-specific, disease-specific, or symptom-specific PROMs if needed.

scholarly journals Implementation of patient-reported outcome measures and patient-reported experience measures in melanoma clinical quality registries: a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040751
Author(s):  
Zachary Blood ◽  
Anh Tran ◽  
Lauren Caleo ◽  
Robyn Saw ◽  
Mbathio Dieng ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Outcome Measures ◽  
Cutaneous Melanoma ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Secondary Outcome ◽  
Clinical Quality ◽  
Patient Reported ◽  
Eortc Qlq

ObjectivesTo identify patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in clinical quality registries, for people with cutaneous melanoma, to inform a new Australian Melanoma Clinical Outcomes Registry; and describe opportunities and challenges of routine PROM/PREM collection, especially in primary care.DesignSystematic review.Primary and secondary outcome measuresWhich PROMs and PREMs are used in clinical quality registries for people with cutaneous melanoma, how they are collected, frequency of collection, participant recruitment methods and funding models for each registry.Results1134 studies were identified from MEDLINE, PreMEDLINE, Embase, PsychInfo, Cochrane Database of Abstracts of Reviews of Effects databases and TUFTS Cost-Effectiveness Analysis Registry, alongside grey literature, from database inception to 5th February 2020. Following screening, 14 studies were included, identifying four relevant registries: Dutch Melanoma Registry, Adelphi Real-World Disease-Specific Programme (Melanoma), Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship Registry, and Cancer Experience Registry. These used seven PROMs: EuroQol-5 Dimensions, Functional Assessment of Cancer-General (FACT-G) and FACT-Melanoma (FACT-M), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer 30 (EORTC QLQ-C30), Fatigue Assessment Scale Hospital Anxiety and Depression Scale, Patient-Reported Outcome Measures Information System-29 and one PREM; EORTC QLQ-Information Module 26. PROMs/PREMs in registries were reported to improve transparency of care; facilitate clinical auditing for quality assessment; enable cost-effectiveness analyses and create large-scale research platforms. Challenges included resource burden for data entry and potential collection bias toward younger, more affluent respondents. Feedback from patients with melanoma highlighted the relevance of PROMs/PREMs in assessing patient outcomes and patient experiences.ConclusionsClinical registries indicate PROMs/PREMs for melanoma care can be incorporated and address important gaps, however cost and collection bias may limit generalisability.PROSPERO registration numberCRD42018086737.

scholarly journals The Correlation of Communication Effectiveness and Patient Satisfaction

2021 ◽  
Vol 8 ◽  
pp. 237437352199883
Author(s):  
Yvonne Versluijs ◽  
Maartje Lemmers ◽  
Laura E. Brown ◽  
Amanda I. Gonzalez ◽  
Joost T. P. Kortlever ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Patient Reported Outcome Measures ◽  
Cross Sectional Study ◽  
Patient Reported Outcome ◽  
Communication Effectiveness ◽  
Cross Sectional ◽  
Patient Reported ◽  
Ceiling Effects ◽  
As Relationship ◽  
Current Experience

This study assessed the correlation of 9 questions addressing communication effectiveness (the Communication Effectiveness Questionnaire [CEQ]) with other patient-reported experience measures (PREMs; satisfaction, perceived empathy) as well as patient-reported outcome measures (PROMs; pain intensity, activity tolerance) in patients with musculoskeletal illness or injury. In a cross-sectional study, 210 patients visiting an orthopedic surgeon completed the CEQ and measures of satisfaction with the visit, perceived empathy, pain intensity, and activity tolerance. We evaluated correlations between CEQ and other PREMs and CEQ and PROMs. We measured ceiling effects of the PREMs. Communication effectiveness correlated moderately with other PREMs such as satisfaction (ρ = 0.54; P < .001) and perceived empathy (ρ = 0.54; P < .001). Communication effectiveness did not correlate with PROMs: pain intensity (ρ = −0.01; P = .93) and activity tolerance (ρ = −0.05; P = .44). All of the experience measures have high ceiling effects: perceived empathy 37%, satisfaction 80%, and CEQ 46%. The observation of notable correlations of various PREMs, combined with their high ceiling effects, direct us to identify a likely common statistical construct (which we hypothesize as “relationship”) accounting for variation in PREMs, and then develop a PREM which measures that construct in a manner that results in a Gaussian distribution of scores. At least within the limitations of current experience measures, there seems to be no association between illness (PROMs) and experience (PREMs).

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