scholarly journals Digitalization of adverse event management in oncology to improve treatment outcome—A prospective study protocol

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252493
Author(s):  
Angelika M. R. Kestler ◽  
Silke D. Kühlwein ◽  
Johann M. Kraus ◽  
Julian D. Schwab ◽  
Robin Szekely ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Outcome ◽  
Side Effects ◽  
Adverse Events ◽  
Study Protocol ◽  
Reporting System ◽  
Smartphone Application ◽  
Patient Reporting ◽  
The Impact

The occurrence of adverse events frequently accompanies tumor treatments. Side effects should be detected and treated as soon as possible to maintain the best possible treatment outcome. Besides the standard reporting system Common Terminology Criteria for Adverse Events (CTCAE), physicians have recognized the potential of patient-reporting systems. These are based on a more subjective description of current patient reporting symptoms. Patient-reported symptoms are essential to define the impact of a given treatment on the quality of life and the patient’s wellbeing. They also act against an underreporting of side effects which are paramount to define the actual value of a treatment for the individual patient. Here, we present a study protocol for a clinical trial that assesses the potential of a smartphone application for CTCAE conform symptom reporting and tracking that is adjusted to the standard clinical reporting system rather than symptom oriented descriptive trial tools. The presented study will be implemented in two parts, both lasting over six months. The first part will assess the feasibility of the application with 30 patients non-randomly divided into three equally-sized age groups (<55years, 55-75years, >75years). In the second part 36 other patients will be randomly assigned to two groups, one reporting using the smartphone and one not. This prospective second part will compare the impact of smartphone reported adverse events regarding applied therapy doses and quality of life to those of patients receiving standard care. We aim for early detection and treatment of adverse events in oncological treatment to improve patients’ safety and outcomes. For this purpose, we will capture frequent adverse events of chemotherapies, immunotherapies, or other targeted therapies with our smartphone application. The presented trial is registered at the U.S. National Library of Medicine ClinicalTrials.gov (NCT04493450) on July 30, 2020.

Proton Pump Inhibitors in 2021: Pros, Cons, and Everything in Between

2021 ◽  
pp. 263451612110217
Author(s):  
Joshua A. Sloan ◽  
Philip O. Katz
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Adverse Events ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Drug Class ◽  
Life Threatening

The medical and lay literature has exploded with reports of adverse events associated with proton pump inhibitors over the last 10 to 15 years. The dissemination of these reports to patients and clinicians have created substantial concerns regarding what has been an exceptionally valuable drug class, dramatically improving patient quality of life, and in many cases preventing life threatening side effects of other medication. Patients are more frequently seeking to avoid these medications, and practitioners are reducing or discontinuing them to the patient’s detriment due to a misunderstanding of the data. This review will discuss the data regarding the most commonly publicized adverse events and attempt to put them in perspective.

Quality of life during the first 6 months of interferon-b treatment in patients with MS

2000 ◽  
Vol 6 (5) ◽  
pp. 338-342
Author(s):  
J HA Arnoldus ◽  
J Killestein ◽  
L EMA Pfennings ◽  
B Jelles ◽  
B MJ Uitdehaag ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Depressive Symptoms ◽  
Side Effects ◽  
Physical Functioning ◽  
Bodily Pain ◽  
Significant Linear Trend ◽  
Role Physical ◽  
Sf 36 ◽  
The Impact

Objectives: To determine the quality of life (QoL) of MS patients during the initial 6 months of treatment with interferon-b (IFN-b). Furthermore, to determine whether changes in QoL relate to disability, emotional state, therapeutic expectations or side effect profile. Background: IFN-b has been shown to have beneficial effects on the course of MS. Since the aim of IFN-b treatment is not to cure but to slow down the disease it is important to know how this treatment affects QoL. Surprisingly, the impact of treatment with IFN-b on QoL measures has not been extensively studied so far. Methods: Case report documentation, including EDSS, SF-36 and MADRAS scores, of 51 relapsing-remitting MS patients treated with IFN-b was obtained at baseline and at months 1, 3 and 6. Patients also filled in a form about their expectations of therapy and a questionnaire on side effects. Results: During treatment there was a significant linear trend indicating improvement in the role-physical functioning (RPF) scale of the SF-36 (F1,50=4.9, P=0.032). A transient decrease at month 1 was found in the scale for bodily pain, indicating more experienced pain (F1,50=19.8, P50.001). Subgroup analysis showed that patients with most depressive symptoms on the MADRAS at baseline contributed most to the increase in RPF scores over time (F1,24=5,6 P=0.026). Furthermore, we found associations between adverse event scores and several domains of QoL. Conclusions: Our findings suggest that IFN-b therapy has an impact on QoL of MS patients in that it improves role-physical functioning and transiently worsens experienced bodily pain. QoL during treatment with IFN-b is influenced by depressive symptoms at baseline as well as by treatment-associated side-effects.

The Impact of Adverse Events on Functional Capacity and Quality of Life After HeartWare Ventricular Assist Device Implantation

ASAIO Journal ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Marc D. Samsky ◽  
Carmelo A. Milano ◽  
Salpy Pamboukian ◽  
Mark S. Slaughter ◽  
Emma Birks ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Functional Capacity ◽  
Ventricular Assist Device ◽  
Assist Device ◽  
Ventricular Assist ◽  
Device Implantation ◽  
The Impact

Retrospective Chart Review of Cryopreserved Amniotic Membrane for Knee Pain

2020 ◽  
Author(s):  
Ruben Berrocal Timmons
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Amniotic Membrane ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Final Analysis ◽  
Mean Values ◽  
Number Of Patients ◽  
The Impact

Objective: Treatment of joint pain with an injection of the amniotic membrane has not been adequately studied. This study retrospectively reviewed Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analgesic usage data from patients treated with the injection of cryopreserved amniotic membrane (CAM) in their knees to determine the impact of treatment on patients’ pain, quality of life, and analgesic usage. Methods: Chart review was conducted on 40 patients. Institutional Review Board (IRB) approval was obtained prior to initiation of the project. The membrane was utilized as per the FDA guidance of 21CFR1271. Retrospective data, including demographics, medical history, pain score, quality of life score, analgesic usage and adverse events, were collected from their medical records for each consenting patient through 6 months after CAM injection. Results: A total of 40 patients were considered in the final analysis. Mean VAS for pain level improved from 7.0 to 2.6 (p<0.001). WOMAC daily activity function score improved from a mean score of 52 to 28 (p<0.001). Opioid and non-steroidal anti-inflammatory drug (NSAID) usage decreased from 97% to 25% (p<0.001). No adverse events were reported. Conclusion: Mean values for VAS and WOMAC scores significantly improved at all time points and the number of patients who used analgesics decreased as compared to baseline. CAM injection into painful knee joints decreases pain, improves physical function, and decreases the use of analgesics in the absence of adverse events.

Patient perspectives

2010 ◽  
pp. 181-187
Author(s):  
S. Jos Closs
Keyword(s):  
Quality Of Life ◽  
Neuropathic Pain ◽  
Suicidal Ideation ◽  
Side Effects ◽  
Focus Group ◽  
Drug Treatment ◽  
Sleep Disturbance ◽  
Focus Group Research ◽  
The Impact

The impact of neuropathic pain on quality of life has been under-researched and poorly understood though survey and focus group research is helping to gain better insights into what patients suffer Neuropathic pain can result in significant sleep disturbance, fatigue, and low mood (that sometimes leads to suicidal ideation), and side-effects from drug treatment are common...

Gastrointestinal symptoms of pelvic radiation disease (part 1): literature review

2020 ◽  
Vol 18 (2) ◽  
pp. 40-45 ◽  
Author(s):  
Helen Ludlow ◽  
John Green
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Literature Review ◽  
Patient Experience ◽  
Gastrointestinal Symptoms ◽  
Pelvic Radiation ◽  
Gi Symptoms ◽  
Pelvic Cancer ◽  
The Impact

Radiotherapy used to treat cancers in the pelvic region can have lasting side effects, and the persistence of these symptoms for 3 months or more is described as pelvic radiation disease (PRD). The growing number of pelvic cancer patients being diagnosed and successfully treated is increasing the incidence of PRD. This review examines the literature on the gastrointestinal symptoms of PRD. This includes how PRD is defined, how it is identified and how it relates specifically to the three pelvic cancers in which it most commonly manifests (prostate, gynaecological and colorectal). It pays particular attention to the impact of PRD on patient experience and quality of life. This review is the first part in a series on the GI symptoms of PRD.

scholarly journals 008 Associations between comorbidities and adverse events of antiepileptic drugs and quality of life: a survey of epilepsy patients in australia

2019 ◽  
Vol 90 (e7) ◽  
pp. A3.2-A3
Author(s):  
Jeremy M Welton ◽  
Christine Walker ◽  
Kate Riney ◽  
Alvin Ng ◽  
Lisa M Todd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Antiepileptic Drugs ◽  
List Type ◽  
Linear Regression Models ◽  
Cross Sectional ◽  
Stepwise Selection ◽  
Memory Problems ◽  
The Impact

IntroductionThis study explored the impact of specific types of comorbidities and adverse events (AEs) from antiepileptic drugs (AEDs) on quality of life (QoL) among adult patients with epilepsy (PwE) in Australia.MethodsCross-sectional surveys were completed by PwE, or caregiver proxies, recruited via the online pharmacy application MedAdvisor and Australian PwE Facebook groups from May–August 2018 Data were collected on demographics, epilepsy severity and management, AEs, comorbidities, and QoL (using QOLIE-10-P total score).1 Multiple linear regression models were constructed to explore associations between AEs or comorbidities and QOLIE-10-P, with possible confounders determined using stepwise selection.Results978 responses were included (mean age 44.5 years, 64% female, 52% employed). 97% reported recent AED use, 47% on AED monotherapy, 35% exposed to ≤2 lifetime AEDs, and 55% seizure-free for >1 year. After stepwise selection, control variables included in both models were: time since diagnosis, employment status, seizure frequency, number of currently prescribed AEDs, and number of general practitioner visits per year. In the model for comorbidities, ‘psychiatric disorders’ was associated with the largest QOLIE-10-P decrease (-23.30, p<0.001). In the model for AEs, which additionally controlled for depression and anxiety disorder, ‘memory problems’ was associated with the largest decrease in QOLIE-10-P (-14.27, p<0.001).ConclusionsIn this survey of Australian PwE, of which many had relatively well-controlled epilepsy, psychiatric and memory problems were common and associated with the greatest detrimental impact on QoL. Further research is needed to understand causality, relationships between possibly interrelated or overlapping symptoms, and management strategies. UCB Pharma-sponsored.ReferenceCramer JA, Perrine K, Devinsky O, Meador K. A brief questionnaire to screen for quality of life in epilepsy: The QOLIE-10. Epilepsia 1996;37:577–582.

scholarly journals Timolol 0.1% in Glaucomatous Patients: Efficacy, Tolerance, and Quality of Life

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Letizia Negri ◽  
Antonio Ferreras ◽  
Michele Iester
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Beta Blockers ◽  
The Other ◽  
Visual Field Defects ◽  
Market Beta ◽  
Systemic Side Effects ◽  
The Impact ◽  
Preservative Free

Glaucoma is a progressive, chronic optic neuropathy characterized by a typical visual field defects. Four main classes of topical medication are actually available on the market: beta-blockers, prostaglandins, alpha2-agonists, and topical carbonic anhydrase inhibitor to treat intraocular pressure (IOP). The aim of this review is to outline the efficacy of timolol and to evaluate the impact of this treatment on patients’ quality of life. Among beta-blockers, timolol is most used at three different concentrations: 0.1%, 0.25%, and 0.5%. While the first one is a gel, the other two products are solution. Timolol has few topical side effects, while it has some important systemic side effects on the cardiac and respiratory systems. The balance between efficacy and safety is always the main aspect to care patients. Because of the less efficacy of timolol 0.1% solution, the possibility to use carbomers as vehicle in the gel drops helped timolol 0.1 to be used in clinics, extending the time contact between the active ingredient and the surface of the cornea. Using preservative-free timolol 0.1 for treatment, IOP was at the same level of the other beta-blockers at higher concentration, but it was better tolerated. Preservative-free treatment improved the quality of life reducing dry-eye like symptoms; furthermore, the presence of an artificial tear in the medication bottle could help adherence. The once daily dosing improves compliance.

Impact of Extracorporeal Photochemotherapy on the Clinical and Economical Management of Patients Affected with GVHD.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 5293-5293
Author(s):  
Cesare Perotti ◽  
Paola Isernia ◽  
Claudia Del Fante ◽  
Gianluca Viarengo ◽  
Daniela Bressan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Cost Analysis ◽  
Short Form ◽  
Extracorporeal Photochemotherapy ◽  
Short Period ◽  
The Impact ◽  
Economical Advantage

Abstract Extracorporeal photochemotherapy (ECP) is an effective, relatively new technique, FDA approved for cutaneous T-cell lymphoma, employed as second-third line treatment in patients affected with GVHD not or poorely responsive to standard immunosuppressive drugs. Both aGVHD and cGVHD are the major complications after stem cell transplantation (till to 50% and 80% of the patients, respectively). Corticosteroids, cyclosporine, micofenolate, tacrolimus and various experimental monoclonal antibodies (anti CD40 ligand, anti TNFα etc) are the drugs employed to control GVHD and are burdened with important short and long term side effects. Recently we revised our data about 102 pts (children and adults) treated by ECP in our Institution. The overall response was 75%, permitting to taper or suspend the immunosuppressive therapy (IST) in 67.6% of the pts. The economical and social impact (cost analysis and quality of life) of ECP vs standard IST was calculated basing on the National Price List and on Short Form Quality of Life (QoL) Scoring System. The cost of ECP comprehensive of the leukapheresis procedure, waste matherials and dedicated personnel was estimated as 684.51 Euro/procedure. On the other side, when the solely costs of the most common IST drugs (corticosteroids, cyclosporine) were considered for 5 months of treatment, an evident and obvious economical advantage emerged (120,3 E). On the contrary, when the costs of hospitalisation and day hospital regimen derived from the most common side effects related to the solely use of IST were included in our cost analysis studies, an economical advantage for long term ECP treatment (calculated on 16 procedures) was demonstrated (14952.16 E vs 17553 E). Moreover, when the “real life implication” calculated on the QoL parameters were considered, the advantages were more evident. In conclusion, the tie of respecting strictly an imposed program of budget calculated on the short period may exert an inhibitory effect in introducing new diagnostic or therapeutic procedures ignoring that the improvement or the cure of the patient has always a positive economical counterpart, expecially when the impact of a new technology is considered in a long term view.

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