scholarly journals Assessing change in patient-reported quality of life after elective surgery: protocol for an observational comparison study

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 976 ◽  
Author(s):  
Vanessa L. Kronzer ◽  
Michelle R. Jerry ◽  
Michael S. Avidan

Despite their widespread use, the two main methods of assessing quality of life after surgery have never been directly compared. To support patient decision-making and study design, we aim to compare these two methods. The first of these methods is to assess quality of life before surgery and again after surgery using the same validated scale. The second is simply to ask patients whether or not they think their post-operative quality of life is better, worse, or the same. Our primary objective is to assess agreement between the two measures. Secondary objectives are to calculate the minimum clinically important difference (MCID) and to describe the variation across surgical specialties. To accomplish these aims, we will administer surveys to patients undergoing elective surgery, both before surgery and again 30 days after surgery. This protocol follows detailed guidelines for observational study protocols.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12095-12095
Author(s):  
Joerg Peter Schilling ◽  
Steffi Busch ◽  
Carsten Hielscher ◽  
Martin Holländer ◽  
Julia Klenske ◽  
...  

12095 Background: NEPA is a fixed combination antiemetic of the NK1-receptor-antagonist (RA) netupitant and the 5-HT3-RA palonosetron. Primary objective of this prospective non-interventional study in Germany was to assess quality of life of cancer patients (pts) undergoing moderately (MEC) or highly (HEC) emetogenic chemotherapy (CT) who received NEPA for prophylaxis of nausea and vomiting (CINV). Secondary objectives were patient reported outcomes as well as effectiveness and safety of NEPA. Here we report final data of the quality of life analysis. Methods: The study included 2.405 pts in 162 centers receiving 3 consecutive cycles of CT as one or two day MEC or HEC. Primary endpoint was impact of quality of life (QoL) due to vomiting or nausea, documented by Functional Living Index–Emesis (FLIE) questionnaires. Effectiveness was reported in patient diaries. Complete response (CR) was defined as no emesis and no rescue medication (RM). Non-significant nausea (NSN) was no or mild nausea. Adverse events (AEs) were reported on d1–21 of each cycle. Results: 2.173 patients were included in the final analysis (full analysis set; FAS). The majority of patients (n = 1976; 91%) received 1-day chemotherapy, 64% HEC, 36% MEC. Median age was 58 years and the majority (85%) was female. Cancer diagnoses: breast 66%, gastrointestinal 10%, ovarian 7% or lung 5%, other 12%. Chemotherapy: AC 57%, carboplatin 19%, cisplatin 8%, oxaliplatin 8% and other 8%. 84% of pts with HEC and 82% with MEC felt no impact on daily life due to vomiting in cycle 1 remaining constant in C2 and C3. 54% HEC patients and 59% MEC patients reported no impact on daily life due to nausea in cycle 1. CR rates ranged between 81-84% and were comparable between different HEC or MEC. NSN rates in MEC ranged from 75% (MEC) to 62% (HEC). Drug-related AEs were rare with constipation, fatigue, insomnia, and nausea as the most common (in > 1% pts). Conclusions: NEPA was highly effective in the prevention of CINV and maintenance of QoL in this real world study. Over 80% of pts reported that their daily live was not influenced by emesis while nausea was more difficult to control. Effectiveness was high and patients and physicians estimate was comparable.


Author(s):  
Jessica A. Tang ◽  
Taemin Oh ◽  
Justin K. Scheer ◽  
Andrew T. Parsa

The patient-generated index (PGI) is a more novel approach to evaluating health-related quality of life (HRQOL) that allows patients to formulate their own responses in an open-ended format in order to measure HRQOL based on each patient’s own stated goals and expectations. To date the use of PGI in the setting of patients diagnosed with cancer remains relatively less common compared to other health conditions. This systematic review primarily aims to identify current literature in which PGI has been used as a tool to assess quality of life in cancer patients. A systematic review using the MEDLINE database from January 1990 to July 2013 was performed with the following search terms to identify the implementation of PGI in oncology settings: (PGI OR patient generated index OR patient-generated OR patient-reported OR patient generated OR patient reported) AND (cancer OR oncology OR tumor OR neoplasm OR malignancy). Of the 2167 papers initially identified, 10 papers evaluated quality of life in oncology patients by collecting free-form responses from the patient, 4 of which actually used PGI. An overarching theme observed in these studies highlighted the concerns mentioned by patients that were not targeted or detected by standardized quality of life measures. While implementing the PGI may require slightly more investment of resources in the beginning, the potential implications of allowing patients to characterize their quality of life on their own terms are tremendous.


In Vivo ◽  
2021 ◽  
Vol 35 (2) ◽  
pp. 1235-1245
Author(s):  
ALEXANDRA KORELI ◽  
GEORGE BRIASSOULIS ◽  
MICHAIL SIDERIS ◽  
ANASTAS PHILALITHIS ◽  
SAVVAS PAPAGRIGORIADIS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii180-ii181
Author(s):  
Sung Choi ◽  
Emily Kowalski ◽  
Rahul Khairnar ◽  
Mark Mishra

Abstract The Quality-of-Life in Neurological Disorders (Neuro-QOL) instruments are a practical set of validated tools utilized to measure a core set of health-related quality-of-life parameters that are relevant to patients with neurological disorders. The tools can be completed in approximately 1-minute. The primary objective of this study was to evaluate the feasibility of utilizing the eight-question Neuro-QoL Cognitive Function- Short Form (NCF-SF) tool (v2.0) to assess cognitive outcomes in patients with primary and secondary brain tumors undergoing radiotherapy. Patients completed the NCF-SF at baseline and during follow-up visits. Raw scores were converted to a standardized T-score that has been normalized to have mean score of 50 and standard deviation (SD) of 10. Descriptive statistical analyses were performed to assess the prevalence of baseline cognitive impairment (defined as > 1 SD below the normative mean), and to assess longitudinal changes in Neuro-QOL scores. A minimum clinically important difference (MCID) was defined as a change from baseline of >7.5, based on previously published literature. Ninety-one patients completed NCF-SF at baseline and at least one follow-up visit. The mean baseline score for the study cohort was 49.9 (SD 9.2). Nineteen percent of patients (n=17/91) had impaired function at baseline. Baseline scores did not differ based on tumor type (p=0.79): Glioma/ependymoma 49.6 (n=35); brain metastases 49.1 (n=24); Meningioma/benign 50.7 (n=32). Following radiation, 15% and 22% of patients experienced a MCID decline at 1- (n=60) and 3- months (n=65), respectively. However, 17% and 20% of patients demonstrated a MCID improvement at 1- and 3-months, respectively. In conclusion, this represents the first study to utilize the NCF-SF to measure cognitive function in patients undergoing brain radiotherapy. Use of NCG-SF was feasible, and identified patients with meaningful changes in cognitive function over time. Future clinical trials may consider use of Neuro-QOL to assess patient-perceived cognitive function.


2010 ◽  
Vol 28 (15_suppl) ◽  
pp. e19610-e19610 ◽  
Author(s):  
R. Tuli ◽  
R. A. Chandra ◽  
E. Sugar ◽  
J. P. Christodouleas ◽  
R. A. Flynn ◽  
...  

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20669-e20669
Author(s):  
Christine Bettine Boers-Doets ◽  
Hans Gelderblom ◽  
Joel Brian Epstein ◽  
Mario E. Lacouture ◽  
Ad A Kaptein

e20669 Background: Mucocutaneous adverse events (mcAEs), including papulopustular rash, xerosis, pruritus, paronychia, hand-foot skin reaction, edema, taste alterations, oral pain and ulceration, hair-, periungual-, and ocular changes occur in the majority of patients during targeted anticancer therapies. Different mcAEs can be present with a variable symptom burden and affect upon patients’ quality of life. Use of standardized targeted therapy specific tools allows comparison of outcomes from different studies and in meta-analyses, advancing patient care and improving outcomes. A mcAE specific assessment tool about symptom burden is currently not available. A questionnaire which assesses both targeted therapy specific patient reported outcomes (PRO) measures and healthcare provider reported outcomes (HPRO) measures is warranted, therefore. Methods: A three-phase process was utilized for item generation, item reduction and scale construction. A comprehensive literature review was performed in PubMed, CINAHL and Embase, and study protocols were screened. Keywords were assessment, questionnaire, tool, EGFRI, and rash. All items with potential relevance for the tool were selected for further evaluation. Twentyone EGFRI treated patients filled out the draft-questionnaire. Results: The search resulted in a simultaneous tool in the form of 61 PRO, and 50 HPRO items. Both tools assess experienced mcAEs inclusive number of papules and pustules, area involved, severity and duration of the symptoms, used products, effectiveness of various (medical) interventions, treatment adherence and distress from the symptoms. Patient input resulted in the addition of 1 item, modification of 7 items, and deletion of 2 items. Conclusions: A novel tool has been generated to assess the experienced mcAEs and effectiveness of supportive care interventions. Since the patient and the provider report mcAEs simultaneously, the provided data are directly comparable, facilitating assessment of quality of life and, therefore, improving quality of medical care.


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