scholarly journals Pain and Emotional Well-Being Outcomes in Southwest Oncology Group–Directed Intergroup Trial S0205: A Phase III Study Comparing Gemcitabine Plus Cetuximab Versus Gemcitabine As First-Line Therapy in Patients With Advanced Pancreas Cancer

2010 ◽  
Vol 28 (22) ◽  
pp. 3611-3616 ◽  
Author(s):  
Carol M. Moinpour ◽  
Nancy L. Vaught ◽  
Bryan Goldman ◽  
Mary W. Redman ◽  
Philip A. Philip ◽  
...  
Keyword(s):  
Brief Pain Inventory ◽  
Well Being ◽  
Phase Iii ◽  
Significant Treatment ◽  
First Line Therapy ◽  
Pain Status ◽  
Study Results ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

PurposeS0205 was a randomized clinical trial that compared the therapeutic impact of gemcitabine versus gemcitabine plus cetuximab. Study results for patient-reported health-related quality of life (HRQL) outcomes are reported.Patients and MethodsPatients completed the Brief Pain Inventory and a measure of emotional well-being (each measured on a 0 to 10 scale) at baseline and at weeks 5, 9, 13, and 17 postrandom assignment. Worst pain status was classified as palliated (worst pain scores < 5 maintained for 2 consecutive cycles) or not palliated (remaining patients) and tested with a χ2test. Change in emotional well-being and worst pain (exploratory analysis) were assessed over 17 weeks using generalized estimating equations with inverse probability of censoring weights.ResultsSeven hundred twenty of 766 enrolled patients contributed baseline HRQL data. The two treatment arms did not differ statistically in the percentage of patients with successful worst pain palliation. Longitudinal analyses showed significantly improved emotional well-being for patients on both arms by weeks 13 and 17 (P < .01 and P < .001). An exploratory longitudinal analysis of worst pain showed significant decreases at all time points for both arms (P < .01 and P < .001). Significant treatment arm differences for either worst pain or emotional well-being were not observed at any of the assessment times.ConclusionWe observed palliated pain and improved well-being for patients on this trial. However, these improvements were similar in both treatment arms, suggesting that the addition of cetuximab did not contribute to improvement in these HRQL outcomes.

scholarly journals Prospective observational study to examine health-related quality of life and develop models to predict long-term patient-reported outcomes 6 months after hospital discharge with blunt thoracic injuries

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e049292
Author(s):  
Edward Baker ◽  
Ceri Battle ◽  
Abhishek Banjeri ◽  
Edward Carlton ◽  
Christine Dixon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hospital Discharge ◽  
Brief Pain Inventory ◽  
Thoracic Injuries ◽  
Patient Reported ◽  
Related Quality ◽  
Paindetect Questionnaire ◽  
Health Related

ObjectiveThis study aimed to examine the long-term outcomes and health-related quality of life in patients with blunt thoracic injuries over 6 months from hospital discharge and develop models to predict long-term patient-reported outcomes.DesignA prospective observational study using longitudinal survey design.SettingThe study recruitment was undertaken at 12 UK hospitals which represented diverse geographical locations and covered urban, suburban and rural areas across England and Wales.Participants337 patients admitted to hospital with blunt thoracic injuries were recruited between June 2018–October 2020.MethodsParticipants completed a bank of two quality of life surveys (Short Form-12 (SF-12) and EuroQol 5-Dimensions 5-Levels) and two pain questionnaires (Brief Pain Inventory and painDETECT Questionnaire) at four time points over the first 6 months after discharge from hospital. A total of 211 (63%) participants completed the outcomes data at 6 months after hospital discharge.Outcomes measuresThree outcomes were measured using pre-existing and validated patient-reported outcome measures. Outcomes included: Poor physical function (SF-12 Physical Component Score); chronic pain (Brief Pain Inventory Pain Severity Score); and neuropathic pain (painDETECT Questionnaire).ResultsDespite a trend towards improving physical functional and pain at 6 months, outcomes did not return to participants perceived baseline level of function. At 6 months after hospital discharge, 37% (n=77) of participants reported poor physical function; 36.5% (n=77) reported a chronic pain state; and 22% (n=47) reported pain with a neuropathic component. Predictive models were developed for each outcome highlighting important data collection requirements for predicting long-term outcomes in this population. Model diagnostics including calibration and discrimination statistics suggested good model fit in this development cohort.ConclusionsThis study identified the recovery trajectories for patients with blunt thoracic injuries over the first 6 months after hospital discharge and present prognostic models for three important outcomes which after external validation could be used as clinical risk stratification scores.

scholarly journals Validation of a simple disease-specific, quality-of-life measure for diabetic polyneuropathy

Neurology ◽  
2018 ◽  
Vol 90 (23) ◽  
pp. e2034-e2041 ◽  
Author(s):  
Kelly G. Gwathmey ◽  
Reza Sadjadi ◽  
William B. Horton ◽  
Mark R. Conaway ◽  
Carolina Barnett-Tapia ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Diabetic Polyneuropathy ◽  
Well Being ◽  
Ease Of Use ◽  
Sensorimotor Polyneuropathy ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Disease Specific

ObjectiveWe studied the performance of a 15-item, health-related quality-of-life polyneuropathy scale in the clinic setting in patients with diabetic distal sensorimotor polyneuropathy (DSPN).MethodsPatients with DSPN from 11 academic sites completed a total of 231 Chronic Acquired Polyneuropathy Patient-Reported Index (CAPPRI) scales during their clinic visits. Conventional and modern psychometric analyses were performed on the completed forms.ResultsConventional and modern analyses generally indicated excellent psychometric properties of the CAPPRI in patients with DSPN. For example, the CAPPRI demonstrated unidimensionality and performed like an interval-level scale.ConclusionAttributes of the CAPPRI for DSPN include ease of use and interpretation; unidimensionality, allowing scores to be summed; adequate coverage of disease severity; and the scale's ability to address relevant life domains. Furthermore, the CAPPRI is free and in the public domain. The CAPPRI may assist the clinician and patient with DSPN in estimating disease-specific quality of life, especially in terms of pain, sleep, psychological well-being, and everyday function. The CAPPRI may be most useful in the everyday clinical setting but merits further study in this setting, as well as the clinical trial setting.

Health-Related Quality of Life Measurement in Public Health

2021 ◽  
Vol 43 (1) ◽  
Author(s):  
Robert M. Kaplan ◽  
Ron D. Hays
Keyword(s):  
Public Health ◽  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Well Being ◽  
Publication Date ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Patient-reported outcomes are recognized as essential for the evaluation of medical and public health interventions. Over the last 50 years, health-related quality of life (HRQoL) research has grown exponentially from 0 to more than 17,000 papers published annually. We provide an overview of generic HRQoL measures used widely in epidemiological studies, health services research, population studies, and randomized clinical trials [e.g., Medical Outcomes Study SF-36 and the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29]. In addition, we review methods used for economic analysis and calculation of the quality-adjusted life year (QALY). These include the EQ-5D, the Health Utilities Index (HUI), the self-administered Quality of Well-being Scale (QWB-SA), and the Health and Activities Limitation Index (HALex). Furthermore, we consider hybrid measures such as the SF-6D and the PROMIS-Preference (PROPr). The plethora of HRQoL measures has impeded cumulative science because incomparable measures have been used in different studies. Linking among different measures and consensus on standard HRQoL measurement should now be prioritized. In addition, enabling widespread access to common measures is necessary to accelerate future progress. Expected final online publication date for the Annual Review of Public Health, Volume 43 is April 2022. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

scholarly journals Development of a patient-reported outcome questionnaire for aplastic anemia and paroxysmal nocturnal hemoglobinuria (PRO-AA/PNH)

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Kimmo Weisshaar ◽  
Hannah Ewald ◽  
Jörg Halter ◽  
Sabine Gerull ◽  
Sandra Schönfeld ◽  
...  
Keyword(s):  
Aplastic Anemia ◽  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Patient Reported Outcome ◽  
Phase Iii ◽  
Specific Patient ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Core Symptoms ◽  
Missing Items

Abstract Background The introduction of new therapy modalities has significantly improved the outcome of aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) patients. However, relatively little is known about the exact disease burden of AA/PNH since standardized assessments of symptoms including health-related quality of life (HRQoL) are frequently missing or inadequately designed for this rare patient group. We aimed to develop AA/PNH-specific questionnaires for self-reporting of symptoms, which could be included in electronic platforms for data collection and patient care. Methods By scoping review, we extracted any reported symptoms in AA/PNH and their prevalence from the literature (Phase I). Consensus rounds with patients and medical experts were conducted to identify core symptoms reported in the literature and to add missing items (Phase II). Ultimately, AA/PNH-specific patient-reported outcome (PRO) questionnaires including the selected measures were designed (Phase III). Results AA symptoms from 62 and PNH symptoms from 45 observational studies were extracted from the literature. Twenty-four patients and seven medical experts identified 11 core symptoms including HRQoL issues after three consensus rounds. Significant differences in the symptom ranking of patients versus medical experts could be observed. Therefore, patient- as well as expert-centered PRO questionnaires in AA and PNH were created following the concepts of validated instruments. Conclusion The development of symptom self-reporting questionnaires for AA and PNH was feasible and the disease-specific PRO questionnaires can now be validated within a web-based workflow in a subsequent feasibility study.

Health-related quality of life and pain assessment in 36 patients with resected pancreas adenocarcinoma: Preliminary analysis

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20692-e20692
Author(s):  
B. I. Carr ◽  
D. Summers ◽  
L. Menefee ◽  
S. Pierpoint ◽  
C. Yeo ◽  
...  
Keyword(s):  
Tumor Size ◽  
Pearson Correlation ◽  
Brief Pain Inventory ◽  
Well Being ◽  
Pain Severity ◽  
Pathology Report ◽  
Disease Extent ◽  
Pancreas Adenocarcinoma ◽  
Related Quality ◽  
Health Related

e20692 Background: In order to begin to understand the effects of disease on the patient (pt) and possibly of the pt on the disease, we have begun a systematic psychological inventory of all our pts who have has a pancreatectomy for pancreas adenocarcinoma and have began to correlate this with disease extent, and later with survival. Methods: Prior to post-op discharge home, pts were invited to fill out a brief pain inventory (BPI-SF), BPI interference, emotional (EWB) and physical well-being score (Fact-Hep), as well as social/family and functional well-being (FWB) Fact-Hep. The data was entered into a database, together with pertinent lab results, tumor markers, and tumor characteristics from the pre-op CT scan and post-op pathology report. Data was analyzed by descriptive statistics, frequencies and Pearson Correlation (2-tailed sig). Results: Descriptive means (and ranges) were - tumor size 3.43 cm mean (2.0 min-5.2 max), bilirubin 1.26 (0.2–4.7), albumin 2.69 (1.5–3.6), Hb 10.3 (7.5–13.2), platelets 254K (109K-672K), CEA 4.7 (0.8–24), and Ca 19–9 was 987 (1.0–8127). Pain at presentation pre-op of moderate severity was present in 11% of pts and severe pain was present in 5.6% of pts (16.6% total). Pathologically, LNs were involved by cancer in 50% of pts, vascular invasion in 30%, neural invasion in 35% and any margin positive in 14%. 22% had metastases noted at surgery. Statistically significant correlations were found for tumor size and pain severity (p<.035), platelets and FWB (p<.022), albumin and Hb (p=.000), CA 19–9 and bilirubin (p<.030 i.e. high CA 19–9 and high bilirubin). There was a negative correlation between CEA (but not CA 19–9) and both EWB (p<.039) and FWB (p<.035). Pain severity correlated with depressed mood (p<.010), lower physical well-being (p<.01) and interference with life activities (p<.01). Conclusions: CEA, but not CA 19–9 correlated with both emotional and functional well-being. Baseline pain was present in only 16.6% of this cohort. We plan to follow up to examine how these parameters correlate with pt coping throughout therapy and survival. No significant financial relationships to disclose.

Relationship between financial toxicity and health-related quality of life in patients with advanced solid tumors.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 31-31
Author(s):  
Jonas A. De Souza ◽  
Bonnie J. Yap
Keyword(s):  
Quality Of Life ◽  
Well Being ◽  
Tumor Type ◽  
Financial Toxicity ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
The Cost

31 Background: Financial toxicity is an important Patient-Reported Outcome (PRO). Its relationship with health-related quality of life (HRQOL) has not been previously described. Therefore, we report the relationship between financial toxicity and health-related quality of life (HRQOL) in patients with advanced cancers. Methods: The global HRQOL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G) and its subscales Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Financial toxicity was assessed by the COST (COmprehensive Score for financial Toxicity), a PRO measure previously developed in 155 patients with advanced cancers. Correlations were calculated using Spearman's correlation. Subject data on tumor type, age, gender, race, income, insurance type and educational level were collected. Results: Fifty patients were assessed. All participants were diagnosed with advanced cancers, were receiving treatment at the time of participation, and had received treatment for at least 3 months. The median COST was 22 (range 0-44), and mean 22.51 (s.d. ±10.80). A negative correlation existed between the COST and HRQOL as measured by the FACT-G (r = -0.47, P <.001), and its subscales: PWB (r=-0.35, p < 0.05), SWB (r=-0.33, p < 0.05), EWB (r=-0.32, p < 0.05) and FWB (r=-0.41, p < 0.01). In this small sample, there were no correlations between the COST and sociodemographic characteristics. Conclusions: Results demonstrate an inverse relationship between patient-reported HRQOL and financial toxicity, suggesting that higher financial toxicity is associated with worse HRQOL. A larger study is in progress to identify cancer patients at higher risk of financial toxicity.

scholarly journals Phase III Comparison of Tamoxifen Versus Tamoxifen Plus Ovarian Function Suppression in Premenopausal Women With Node-Negative, Hormone Receptor–Positive Breast Cancer (E-3193, INT-0142): A Trial of the Eastern Cooperative Oncology Group

2014 ◽  
Vol 32 (35) ◽  
pp. 3948-3958 ◽  
Author(s):  
Amye J. Tevaarwerk ◽  
Molin Wang ◽  
Fengmin Zhao ◽  
John H. Fetting ◽  
David Cella ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Premenopausal Women ◽  
Menopausal Symptoms ◽  
Phase Iii ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Purpose The effects of ovarian function suppression (OFS) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS. Patients and Methods Premenopausal women with axillary node-negative, hormone receptor–positive breast cancer tumors measuring ≤ 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS; adjuvant chemotherapy was not permitted. Primary end points were disease-free survival (DFS) and overall survival (OS). Secondary end points included toxicity and patient-reported outcomes. Patient-reported outcome data included health-related quality of life, menopausal symptoms, and sexual function. These were evaluated at baseline, 6 months, 12 months, and then annually for up to 5 years after registration. Results In all, 345 premenopausal women were enrolled: 171 on tamoxifen alone and 174 on tamoxifen plus OFS. With a median follow-up of 9.9 years, there was no significant difference between arms for DFS (5-year rate: 87.9% v 89.7%; log-rank P = .62) or OS (5-year rate: 95.2% v 97.6%; log-rank P = .67). Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm (22.4% v 12.3%; P = .004). Patients treated with tamoxifen plus OFS had more menopausal symptoms, lower sexual activity, and inferior health-related quality of life at 3-year follow-up (P < .01 for all). Differences diminished with further follow-up. Conclusion When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.

scholarly journals Longitudinal prospective evaluation of oral health-related quality of life in young patients undergoing fixed orthodontic appliance treatment as part of a randomised trial

2020 ◽  
Author(s):  
Mustafa Elhussein ◽  
Philip Benson
Keyword(s):  
Quality Of Life ◽  
Oral Health ◽  
Orthodontic Treatment ◽  
Well Being ◽  
Health Related Quality ◽  
Patient Reported ◽  
Before And After ◽  
Related Quality ◽  
Health Related

Abstract Background The objectives of this study were to investigate relationships between change in the aesthetic appearance before and after orthodontic treatment and patient-reported change in oral health-related quality of life (OHRQoL), and to assess the responsiveness of two OHRQoL measures to any changes from orthodontic treatment. Methods Two hundred and ten participants in a multicentre (two teaching hospitals and four specialist orthodontic practices), single blinded, randomised clinical trial with 2 parallel groups, were administered one of two age-specific questionnaires, either the Child Perceptions Questionnaire (CPQ11-14-ISF-16) or the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ), before and after orthodontic treatment. Clinical photographs were assessed by two groups of laypeople and orthodontists using the Index of Orthodontic Treatment Need Aesthetic Component (IOTN-AC). Results Two hundred and ten participants were randomised, and 197 completed the trial. Before and after OHRQoL data were successfully obtained from 110 participants. There was a mean reduction in the total CPQ11-14-ISF-16 scores of 3.9 (SD = 8.0), and a mean reduction of 34.2 (SD = 18.5) in the total PIDAQ score. CPQ11-14-ISF-16 demonstrated poor longitudinal construct validity (p = 0.155). Correlations between the change in total CPQ11-14-ISF-16 scores and change in IOTN-AC assessments were small for both orthodontists (r=-0.084; p = 0.516) and laypeople (r=-0.140; p = 0.225). There were higher associations between the improvement in the Social well-being (SWB) subdomain and improvement in IOTN-AC. Correlations between the changes in total PIDAQ scores and the IOTN-AC assessments, were higher in comparison to the correlations with CPQ11-14-ISF-16 (orthodontists; r = 0.223, laypeople; r = 0.025). There were no adverse effects. Conclusion CPQ11-14-ISF-16 and IOTN-AC measure different attributes. This demonstrated the role of SWB on children OHRQoL. Condition-specific measures (PIDAQ) are more responsive to change in self-reported OHRQoL than generic measures (CPQ11-14-ISF-16) after treatment. Trial Registration: The trial was registered at ClinicalTrials.gov NCT01925924.

Weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients (pts) with advanced non-small cell lung cancer (NSCLC): Analysis of patient-reported neuropathy and taxane-associated symptoms.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS7618-TPS7618
Author(s):  
Vera Hirsh ◽  
Isamu Okamoto ◽  
Jeremy K. Hon ◽  
Shaker R. Dakhil ◽  
Ray D. Page ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Neuropathic Pain ◽  
Phase Iii ◽  
Tolerability Profile ◽  
Significant Treatment ◽  
First Line Therapy ◽  
Patient Reported ◽  
Associated Symptoms ◽  
Clinically Significant ◽  
Hands And Feet

TPS7618 Background: Neuropathy and its associated symptoms are dose-limiting toxicities of taxane-based regimens. Measuring disease symptoms has utility for maintaining a balance between the benefits and costs of treatment. In a phase III trial nab-paclitaxel (nab-P, 130 nm albumin-bound paclitaxel particles) + carboplatin (C) vs solvent-based paclitaxel (sb-P) + C significantly improved the primary endpoint of overall response rate (ORR) (25% vs 33%, P = 0.005), with a 1-month improvement in median overall survival (OS; P = NS), and an improved tolerability profile in pts with advanced NSCLC. Here we report on patient-assessed neuropathy and taxane-associated symptoms, important factors in a palliative patient setting. Methods: Pts with untreated stage IIIB/IV NSCLC were randomized 1:1 to C AUC 6 day 1 and either nab-P 100 mg/m2 on days 1, 8, 15 (n = 521) or sb-P 200 mg/m2 day 1 (n = 531) q 21 days. Treatment was continued until disease progression. Safety was assessed per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. The mean change from baseline to day 1 of each cycle for the neuropathy, pain, and hearing subscales of Functional Assessment of Cancer Therapy (FACT)‑Taxane v 4.0 were assessed. Results: 1031 (98%) pts completed FACT-Taxane at baseline, and 987 (94%) during follow-up or at completion of treatment. Baseline scores for neuropathy and pain were well balanced. Significant treatment effects favoring nab-P/C were noted for patient-reported neuropathy (P < 0.001), neuropathic pain hands/feet (P < 0.001), and hearing loss (P = 0.002). Physician-assessed rates of neuropathy were significantly lower in the nab-P/C arm vs the sb-P/C arm: 47% vs 63%, P < 0.001, all grades; 3% vs 12%, P < 0.001, grade 3/4, respectively. More pts treated with nab-P/C vs sb-P/C had no neuropathy (53% vs 47%, P < 0.001). Conclusions: nab-P/C was associated with statistically and clinically significant reductions in patient-reported neuropathy, neuropathic pain in the hands and feet, and hearing loss compared with sb-P/C. Patient-reported outcomes for neuropathy were consistent with physician assessment.

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