PD54-02 THE IMPACT OF URETERAL STENT OMISSION AND AN OPIATE-FREE PROTOCOL ON PATIENT REPORTED OUTCOMES FOLLOWING URETEROSCOPY

This overview draws out the main conclusions from the 4 workshops focused on incorporating the patient perspective into outcome assessment at the 10th Outcome Measures in Rheumatology (OMERACT 10) conference. They raised methodological issues about the choice of outcome domains to include in clinical trials, the development or choice of instruments to measure these domains, and the way these instruments might capture the impact of a disease and its treatment. The need to develop a more rigorous conceptual model of quantifying the way conditions affect health, and the need to ensure patients are directly involved in the decisions about domains and instruments, emerged clearly. The OMERACT participants voted to develop guidelines for domain and instrument selection, and conceptual and experimental work will be brought forward to revise and upgrade the OMERACT Filter.

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The impact of a recent relapse on patient-reported outcomes in subjects with multiple sclerosis

Quality of Life Research ◽

10.1007/s11136-011-0108-0 ◽

2012 ◽

Vol 21 (10) ◽

pp. 1677-1684 ◽

Cited By ~ 19

Author(s):

Brian C. Healy ◽

Irene R. Degano ◽

Ana Schreck ◽

David Rintell ◽

Howard Weiner ◽

...

Keyword(s):

Multiple Sclerosis ◽

Patient Reported Outcomes ◽

Patient Reported ◽

The Impact

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Patient reported outcomes in patients with desmoid type fibromatosis.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.11574 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 11574-11574

Author(s):

VIKAS GARG ◽

Sameer Rastogi ◽

Adarsh Barwad ◽

Rambha Panday ◽

Sandeep Kumar Bhoriwal ◽

...

Keyword(s):

Patient Reported Outcomes ◽

Symptom Burden ◽

Benign Neoplasm ◽

Anxiety And Depression ◽

Appendicular Skeleton ◽

Healthy Controls ◽

Symptom Scale ◽

Cross Sectional ◽

Patient Reported ◽

The Impact

11574 Background: Desmoid type fibromatosis (DTF) is a rare benign neoplasm with infiltrative growth and high local recurrences. Due to long disease course, unpredictable growth pattern, and low mortality, using only survival outcomes may be inappropriate. In this study we assessed the impact of DTF on health related quality of life (HRQoL). Methods: This was a cross-sectional study done in patients with DTF. The study participants were asked to fill the EORTC QLQ-C30, GAD-7 and PHQ- 9 q uestionnaires to assess HRQoL, anxiety and depression . Outcomes were also compared with healthy controls. Results: 204 subjects (102 DTF patients and 102 healthy controls) were recruited. Study parameters have been summarized in Table. Appendicular skeleton (limbs + girdle) was most commonly involved in 59 % patients and abdominal wall or mesentery was involved in 22.5 %. Patients have received median of 2 lines of therapy. 54 % patients were currently on sorafenib and 41 % were under active surveillance. Mean global health status in DTF patient 65.58 ± 22.64, was significantly lower than healthy controls. Similarly, DTF patients scored low on all functional scales except cognitive functioning. Symptom scale showed significantly higher symptom burden of fatigue, pain, insomnia and financial difficulties. Anxiety & depression was observed in 39.22 % and 50 % of DTF patients respectively. DTF patients had higher rates of mild, moderate and severe anxiety and depression compared to healthy controls. No difference was observed based on site of disease. Conclusions: DTF patients have significant symptom burden, poor functioning, and heightened anxiety and depression. Patient reported outcomes should be routinely used to assess treatment efficacy in DTF patients.[Table: see text]

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The Impact of Obesity on Patient Reported Outcomes Following Stereotactic Body Radiation Therapy for Prostate Cancer

Cureus ◽

10.7759/cureus.669 ◽

2016 ◽

Author(s):

Harsha Koneru ◽

Robyn Cyr ◽

Li Rebekah Feng ◽

Edward Bae ◽

Malika T Danner ◽

...

Keyword(s):

Prostate Cancer ◽

Radiation Therapy ◽

Patient Reported Outcomes ◽

Stereotactic Body Radiation Therapy ◽

Stereotactic Body Radiation ◽

Patient Reported ◽

The Impact

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Analysis of Radiation Dose to the Shoulder by Treatment Technique and Correlation With Patient Reported Outcomes in Patients Receiving Regional Nodal Irradiation

Frontiers in Oncology ◽

10.3389/fonc.2021.617926 ◽

2021 ◽

Vol 11 ◽

Author(s):

Jose G. Bazan ◽

Dominic DiCostanzo ◽

Karen Hock ◽

Sachin Jhawar ◽

Karla Kuhn ◽

...

Keyword(s):

Breast Cancer ◽

Radiation Therapy ◽

Radiation Dose ◽

Patient Reported Outcomes ◽

Late Complication ◽

Treatment Technique ◽

Regional Nodal Irradiation ◽

Patient Reported ◽

The Impact ◽

Dash Questionnaire

Background/PurposeShoulder/arm morbidity is a late complication of breast cancer treatment with surgery and regional nodal irradiation (RNI). We set to analyze the impact of radiation technique [intensity modulated radiation therapy (IMRT) or 3D conformal radiation therapy (3DCRT)] on radiation dose to the shoulder with a hypothesis that IMRT use results in smaller volume of shoulder receiving radiation. We explored the relationship of treatment technique on long-term patient-reported outcomes using the quick disabilities of the arm, shoulder, and hand (q-DASH) questionnaire.Materials/MethodsWe identified patients treated with adjuvant RNI (50 Gy/25 fractions) from 2013 to 2018. We retrospectively contoured the shoulder organ-at-risk (OAR) from 2 cm above the ipsilateral supraclavicular (SCL) planning target volume (PTV) to the inferior SCL PTV slice and calculated the absolute volume of shoulder OAR receiving 5–50 Gy (V5–V50). We identified patients that completed a q-DASH questionnaire ≥6 months from the end of RNI.ResultsWe included 410 RNI patients: 54% stage III, 72% mastectomy, 35% treated with IMRT. IMRT resulted in significant reductions in the shoulder OAR volume receiving 20–50 Gy vs. 3DCRT. In total, 82 patients completed the q-DASH. The mean (SD) q-DASH=25.4 (19.1) and tended to be lower with IMRT vs. 3DCRT: 19.6 (16.4) vs. 27.8 (19.8), p=0.078.ConclusionWe found that IMRT reduces radiation dose to the shoulder and is associated with a trend toward reduced q-DASH scores ≥6 months post-RNI in a subset of our cohort. These results support prospective evaluation of IMRT as a technique to reduce shoulder morbidity in breast cancer patients receiving RNI.

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Patient-reported outcomes before and after treatment of major depressive disorder

Dialogues in Clinical Neuroscience ◽

10.31887/dcns.2014.16.2/rcohen ◽

2014 ◽

Vol 16 (2) ◽

pp. 171-183 ◽

Cited By ~ 5

Keyword(s):

Depressive Symptom ◽

Symptom Severity ◽

Patient Reported Outcomes ◽

Burden Of Illness ◽

Major Depressive ◽

Patient Reported ◽

Before And After ◽

Depressive Symptom Severity ◽

The Impact ◽

Level 2

Patient reported outcomes (PROs) of quality of life (QoL), functioning, and depressive symptom severity are important in assessing the burden of illness of major depressive disorder (MDD) and to evaluate the impact of treatment. We sought to provide a detailed analysis of PROs before and after treatment of MDD from the large Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. This analysis examines PROs before and after treatment in the second level of STAR*D. The complete data on QoL, functioning, and depressive symptom severity, were analyzed for each STAR*D level 2 treatment. PROs of QoL, functioning, and depressive symptom severity showed substantial impairments after failing a selective serotonin reuptake inhibitor trial using citalopram (level 1). The seven therapeutic options in level 2 had positive statistically (P values) and clinically (Cohen's standardized differences [Cohen's d]) significant impact on QoL, functioning, depressive symptom severity, and reduction in calculated burden of illness. There were no statistically significant differences between the interventions. However, a substantial proportion of patients still suffered from patient-reported QoL and functioning impairment after treatment, an effect that was more pronounced in nonremitters. PROs are crucial in understanding the impact of MDD and in examining the effects of treatment interventions, both in research and clinical settings.

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Dare voce ai pazienti nella ricerca sulle malattie rare e sui famaci orfani / Giving patients a voice in the rare diseases and orphan drugs research

Medicina e Morale ◽

10.4081/mem.2018.526 ◽

2018 ◽

Vol 67 (1) ◽

pp. 25-40

Author(s):

Elena Mancini ◽

Roberta Martina Zagarella

Keyword(s):

Clinical Trials ◽

Rare Diseases ◽

Patient Reported Outcomes ◽

Narrative Medicine ◽

Orphan Drugs ◽

New Drugs ◽

Patient Centered ◽

Patient Reported ◽

Critical Issues ◽

The Impact

L’articolo ha l’obiettivo di mettere in luce potenzialità e criticità dell’inclusione della prospettiva dei pazienti nella ricerca sulle malattie rare e sui farmaci orfani. A tal fine, nella prima parte, si propone un’analisi epistemologica dell’utilizzo dei racconti dell’esperienza individuale della malattia nella ricerca scientifica e nei trial clinici, facendo emergere, anche attraverso gli strumenti della medicina narrativa, le sfide teoriche e operative poste dall’inclusione della soggettività del paziente e del vissuto di malattia nonché l’importanza della valorizzazione della prospettiva del paziente, sia in generale sia nella ricerca sulle malattie rare e sui farmaci orfani. Nella seconda parte, il testo analizza in particolare il ruolo degli esiti riportati dai pazienti o Patient Reported Outcomes (PROs), misure per la valutazione complessiva della salute basate sulla prospettiva dei pazienti stessi, incentrandosi sulla sperimentazione clinica nel campo delle malattie rare. In questo contesto, infatti, i racconti di malattia, raccolti e valorizzati da fonti istituzionali e associazioni di pazienti, hanno contribuito a far emergere importanti questioni critiche e difficoltà nell’impiego di outcome centrati sul paziente nello sviluppo di nuovi farmaci e trattamenti, generando una serie di documenti e raccomandazioni relative al loro utilizzo per il benessere della comunità dei malati rari. ---------- This paper aims to highlight the potentiality and criticality of including patients’ perspective in rare diseases and orphan drugs research. In the first part, we propose an epistemological analysis of individual narrations of disease experience as they are used in scientific research and clinical trials. With the help of narrative medicine approach, this analysis points out theoretical and operational challenges of a perspective that includes patient’s subjectivity and illness experience. Furthermore, it reveals the significance of patients’ standpoints in general and in rare diseases as well as in the orphan drugs research. The second part of our article focuses on the role of the Patient reported Outcomes (PROs) – which are measures for the health’s overall assessment based on patient’s perspective – by investigating the impact on clinical trials for rare diseases. In this context, illness stories, which are collected and promoted by institutional sources and patients’ associations, contribute to underline important critical issues at stake in the employment of patient-centered outcomes both in new drugs and in the treatments development. Moreover, these stories are crucial to elaborate documents and recommendations concerning the use of PROs for the rare patients’ community welfare.

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Impact of Medium Cut-Off Dialyzers on Patient-Reported Outcomes: COREXH Registry

Blood Purification ◽

10.1159/000508803 ◽

2020 ◽

pp. 1-9

Author(s):

Juan Carlos Alarcon ◽

Alfonso Bunch ◽

Freddy Ardila ◽

Eduardo Zuñiga ◽

Jasmin I. Vesga ◽

...

Keyword(s):

Quality Of Life ◽

Kidney Disease ◽

Repeated Measures ◽

Patient Reported Outcomes ◽

Short Form ◽

High Flux ◽

Middle Molecules ◽

Patient Reported ◽

The Impact

Introduction: A new generation of hemodialysis (HD) membranes called medium cut-off (MCO) membranes possesses enhanced capacities for middle molecule clearance, which have been associated with adverse outcomes in this population. These improvements could potentially positively impact patient-reported outcomes (PROs). Objective: The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. Methods: This was a prospective, multicenter, observational cohort study of 992 patients from 12 renal clinics in Colombia who were switched from high-flux HD to MCO therapy and observed for 12 months. Changes in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQoL-SF36) domains, Dialysis Symptom Index (DSI), and restless legs syndrome (RLS) 12 months after switching to MCO membranes were compared with time on high-flux membranes. Repeated measures of ANOVA were used to evaluate changes in KDQoL-SF36 scores; severity scoring was used to assess DSI changes over time; Cochran’s Q test was used to evaluate changes in frequency of diagnostic criteria of RLS. Results: During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (p < 0.0001), effects of kidney disease (p < 0.0001), and burden of kidney disease (p < 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (p < 0.0001). No significant differences in the number of symptoms (DSI, p = 0.1) were observed, although their severity decreased (p = 0.009). Conclusions: In conventional HD patients, the expanded clearance of large middle molecules with MCO-HD membranes was associated with higher health-related quality of life scores and a decrease in the prevalence of RLS.

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Gastrointestinal Symptoms of and Psychosocial Changes in Inflammatory Bowel Disease: A Nursing-Led Cross-Sectional Study of Patients in Clinical Remission

Medicina ◽

10.3390/medicina56010045 ◽

2020 ◽

Vol 56 (1) ◽

pp. 45 ◽

Cited By ~ 4

Author(s):

Rosellina Margherita Mancina ◽

Raffaele Pagnotta ◽

Caterina Pagliuso ◽

Vincenzo Albi ◽

Daniela Bruno ◽

...

Keyword(s):

Quality Of Life ◽

Patient Reported Outcomes ◽

Gastrointestinal Symptoms ◽

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional ◽

Patient Reported ◽

Inflammatory Bowel ◽

The Impact

Background and Objectives: Nursing management in Inflammatory Bowel Disease (IBD) is focused on global patient care. Starting from basic knowledge of diagnostic and therapeutic management, nurses can assess the impact of IBD on patients’ quality of life not only at the physical level, but also at the psychological, social, and emotional levels. The aim of this study was to evaluate the impact of gastrointestinal symptoms on psychosocial changes in IBD patients in remission through nursing-led Patient-Reported Outcomes. Materials and Methods: We performed a cross-sectional study of 109 IBD patients in clinical and endoscopic remission. Specialist nurses invited patients to complete questionnaires on gastrointestinal symptoms and quality of life through the Patient-Reported Outcomes Measurement Information System (PROMIS). Results: We found that the gastrointestinal symptoms that the patients reported had a significant impact on the analyzed aspects of health. More specifically, belly pain, diarrhea, and bloating were associated with depressive symptoms (p < 0.001), anxiety (p < 0.001), fatigue (p < 0.001), and sleep disturbances (p < 0.001). Moreover, these symptoms also significantly affected patients’ social dimension in terms of satisfaction with participation in social roles (p < 0.001, p < 0.05, and p < 0.001 for belly pain, diarrhea, and bloating, respectively) and physical functions (p < 0.001). The results were virtually the same in a multivariable analysis adjusted by age, gender, body mass index (BMI), and disease duration. Conclusions: Even during remission, gastrointestinal symptoms are the main factors that influence quality of life in IBD patients. This exploratory study highlights the need to adopt validated questionnaires in clinical practice, and demonstrates that PROMIS is a valid, objective, and standardized instrument that can help nursing staff to better define the consequences of the disease in a patient’s daily life.

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