scholarly journals Development of a clinical trials version of the Impact of Weight on Quality of Life-Lite questionnaire (IWQOL-Lite Clinical Trials Version): results from two qualitative studies

2017 ◽  
Vol 7 (5) ◽  
pp. 290-299 ◽  
Author(s):  
R. L. Kolotkin ◽  
C. M. Ervin ◽  
H. H. Meincke ◽  
L. Højbjerre ◽  
S. E. Fehnel
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Qualitative Studies ◽  
The Impact

Spa-therapy can improve quality of life in chronic musculoskeletal disorder subjects: a narrative review

2020 ◽  
Vol 96 (2) ◽  
pp. 3-6
Author(s):  
M.C. Maccarone ◽  
G. Magro ◽  
U. Solimene ◽  
S. Masiero
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Thermal Environment ◽  
Narrative Review ◽  
Spa Therapy ◽  
Age Related ◽  
Therapy Interventions ◽  
The Impact

Chronic Musculoskeletal Disorders (MSDs) are age-related conditions, linked to functional impairment and decreased quality of life (QoL). As a result of the increased life expectancy in Europe, great attention has been focused on investigating the impact of these diseases on QoL. Thermal environment is a suitable place for providing interventions (mud therapy, bath, exercise, etc.) for chronic MSD patients. Our narrative review aims to assess if Spa therapy may improve QoL in patients with chronic MSDs. We searched randomized clinical trials and clinical trials screening PubMed and Google Scholar databases from 2016 up to March 2020. We included 14 trials testing Spa therapy interventions concerning osteoarthritis, rheumatoid arthritis, chronic shoulder pain and fibromyalgia. In conclusion, even though limitations must be considered, evidence shows that Spa therapy, especially in combination with rehabilitation approach, can significantly improve QoL of patients with chronic MSDs.

scholarly journals Impact of patient’s health-related quality of life on physicians’ therapy and perceived benefit in acute coronary syndromes: protocol for a systemic review of quantitative and qualitative studies

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e026595 ◽  
Author(s):  
Billingsley Kaambwa ◽  
Hailay Gesesew ◽  
Matthew Horsfall ◽  
Derek P Chew
Keyword(s):  
Quality Of Life ◽  
Treatment Decisions ◽  
Qualitative Studies ◽  
Systemic Review ◽  
Health Related Quality ◽  
Coronary Syndrome ◽  
Related Quality ◽  
Health Related ◽  
The Impact

IntroductionPercutaneous coronary interventions (PCIs) and coronary angiography are two of the treatments administered to acute coronary syndrome (ACS) patients. However, whether and how patients’ health-related quality of life (HRQoL) influences treatment decisions and subsequent risk benefit analyses is unclear. In this study, we will review the available evidence on the impact of patients’ HRQoL on physicians’ prescribing or treatment decisions and on the estimation of mortality and bleeding risk in ACS patients.Methods and analysisWe will undertake a systematic review of all quantitative and qualitative studies. The search will include studies that describe the impact of HRQoL on prescribing PCIs or angiography, and impact of HRQoL on perceived risks in terms of mortality and bleeding events. We will conduct an initial search on Google scholar and MEDLINE to build the searching terms followed by a full search strategy using all identified keywords and index terms across the five databases, namely MEDLINE, PubMed, CINAHL, SCOPUS and Web of Sciences. We will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for protocol guidelines to present the protocol. Only English language articles will be included for the review. We will use a standardised Joanna Briggs Institute data extraction tool to synthesise the information extracted from the selected studies into themes with summary findings presented in a table.Ethics and disseminationWe will not require a formal ethical approval as we will not be collecting primary data. Review findings will be disseminated through a peer-reviewed publication, workshops, conference presentations and a media release.PROSPERO registration numberCRD42018108438.

scholarly journals Assessment of the impact of treatment on quality of life of patients with haemophilia A at different ages: insights from two clinical trials on turoctocog alfa

Haemophilia ◽  
2014 ◽  
Vol 20 (4) ◽  
pp. 527-534 ◽  
Author(s):  
E. Santagostino ◽  
S. R. Lentz ◽  
A. K. Busk ◽  
A. Regnault ◽  
A. Iorio
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Haemophilia A ◽  
Different Ages ◽  
The Impact

scholarly journals Atopic Dermatitis: Perspectives and Attitudes of Adult Patients and Affected Child Caregivers Assessed by Focus Group

2018 ◽  
Vol 76 (4) ◽  
pp. 399-408
Author(s):  
Alberto Mota
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Atopic Dermatitis ◽  
Focus Group ◽  
Adult Patients ◽  
Personal Experiences ◽  
Topical Treatments ◽  
Item Price ◽  
The Impact

Introduction: Important dimensions such as personal experiences, attitudes toward disease, its causes and treatments, are not fully addressed in clinical trials. Focus group (FG) has emerged as an interesting and valuable tool in clinical research complementing this gap. The aim of this qualitative research was to assess in both caregivers and patients dealing with atopic dermatitis (AD) their attitudes, personal experiences and perspectives toward the disease and its topical treatment as well as the impact in quality of life (QoL).Material and Methods: For discussion sessions, 10 caregivers of children and 10 adult patients were recruited. Two sessions of FG took place with 3 main themes discussed: perspectives toward AD, topical treatments and the impact in QoL. All activities were recorded in video and the discussions and notes were then transcribed to a document, followed by transcripts analysis.Results: The best descriptive feelings in the moment of diagnosis where “concern” (30%) and “quality of life” (30%) for caregivers and patients, respectively. The actual “positive” emotion or state of mind toward the disease was “overcoming” for caregivers (21%) and “control” for patients (17%). The main “negative or neutral” emotion was “fear” for caregivers (13%) and “resignation” for patients (18%), but when projecting to their child, “frustration” (19%) was the most mentioned. In relation to topical treatments, the mean global satisfaction of caregivers was high for tacrolimus (8.5/10), except in the item “price”. In the case of patients, corticosteroids received a better score (8.0/10), with exception for “tolerability/adverse effects”. Features like “preventive treatment with reduction of flares” and “free of cortisone” were important for both participants in an “ideal topical medicine” setting. All participants showed high levels of negative impact in their QoL due to AD, with 47% and 64.6% considering scores of “very much” and “a lot” of interference, respectively.Conclusion: Qualitative studies in AD by FG are scarce and to our knowledge this is the first one gathering both adult patients and caregivers. The dimensions yielded by this approach are useful to complement data retrieved from clinical trials and to drive decisions from researchers and health authorities.

The Prognostic Significance of Patient-Reported Outcomes in Cancer Clinical Trials

2008 ◽  
Vol 26 (8) ◽  
pp. 1355-1363 ◽  
Author(s):  
Carolyn C. Gotay ◽  
Crissy T. Kawamoto ◽  
Andrew Bottomley ◽  
Fabio Efficace
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Prognostic Significance ◽  
Cancer Clinical Trials ◽  
Life Questionnaire ◽  
European Organization ◽  
Patient Reported ◽  
The Impact

Purpose Patient-reported outcomes (PROs), routinely collected as a part of cancer clinical trials, have been linked with survival in numerous clinical studies, but a comprehensive critical review has not been reported. This study systematically assessed the impact of PROs on patient survival after a cancer diagnosis within the context of clinical trials. Design Cancer clinical trials that assessed baseline PROs and mortality were identified through MEDLINE (through December 2006) supplemented by the Cochrane database, American Society of Clinical Oncology/European Society for Medical Oncology abstracts and hand searches. Inclusion criteria were publication in English language and use of multivariate analyses of PROs that controlled for one or more clinical factors. Two raters reviewed each study, abstracted data, and assessed study quality; two additional raters verified abstractions. Results In 36 of 39 studies (N = 13,874), at least one PRO was significantly associated with survival (P < .05) in multivariate analysis, with varying effect sizes. Studies of lung (n = 12) and breast cancer (n = 8) were most prevalent. The most commonly assessed PRO was quality of life, measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 in 56% of studies. Clinical variables adjusted for included performance status (PS), treatment arm, stage, weight loss, and serum markers. Results indicated that PROs provide distinct prognostic information beyond standard clinical measures in cancer clinical trials. Conclusion PROs might be considered for stratification purposes in future trials, as they were often better predictors of survival than PS. Studies are needed to determine whether interventions that improve PROs also increase survival and to identify explanatory mechanisms through which PROs relate to survival.

Impact of Quality of Life on Patient Expectations Regarding Phase I Clinical Trials

2000 ◽  
Vol 18 (2) ◽  
pp. 421-421 ◽  
Author(s):  
Jonathan D. Cheng ◽  
James Hitt ◽  
Bogda Koczwara ◽  
Kevin A. Schulman ◽  
Caroline B. Burnett ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Phase I ◽  
Patient Expectations ◽  
Experimental Therapy ◽  
Phase I Clinical Trials ◽  
Potential Benefits ◽  
Research Nurses ◽  
The Impact

PURPOSE: Quality of life (QOL) is increasingly recognized as a critical cancer-treatment outcome measure, but little is known about the impact of QOL on the patient decision-making process. A pilot study was conducted in an effort to (1) measure the expectations of patients, physicians, and research nurses regarding the potential benefits and toxicities from experimental and standard therapies, and (2) determine the relationship of QOL to patient perceptions regarding treatment options. METHODS: Thirty cancer patients enrolling in phase I clinical trials, their physicians, and their research nurses were administered questionnaires that assessed demographics, QOL, and treatment expectations. RESULTS: Compared with their physicians, patients overestimated potential benefits and toxicities from experimental therapy (mean expected benefit, 59.8% v 23.8%, P < .01; mean expected toxicity, 29.8% v 16.0%, P < .01). Patients estimated a greater potential for benefit (59.8% v 36.8%, P < .01) and less potential for toxicity (29.8% v 45.6%, P = .01) for experimental therapy, compared with standard therapy. Short Form- 36 general health perception correlated with patient perception of potential benefit from experimental therapy (r = .48, P = .01). CONCLUSION: Participants in phase I clinical trial have high expectations regarding the success of experimental therapy and discount potential toxicity. Patient QOL may affect the expectation of benefit from experimental therapy and, ultimately, treatment choice. Understanding the interactions between QOL and patient expectations may guide the development of improved strategies to present appropriate information to patients considering early-phase clinical trials.

A review of clinical endpoints and use of quality-of-life outcomes in phase III metastatic breast cancer clinical trials.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 129-129
Author(s):  
Raman Tatla ◽  
Denis Landaverde ◽  
Charles Victor ◽  
David Miles ◽  
Sunil Verma
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Clinical Endpoints ◽  
Phase Iii Clinical Trials ◽  
The Impact

129 Background: The management of metastatic breast cancer (MBC) is often considered to be palliative, with most interventions intended to relieve disease symptoms, minimize treatment effects and prolong patient survival. The impact of disease and treatment on a patient's funcitonal abilities has led to an emphasis of incorporating quality of life (QoL) measures into clinical trials. The main objective of this study is to evaluate phase III clinical trials in MBC, and assess the inclusion of QOL as an endpoint, in addition to conventional efficacy endpoints. Methods: A structured PubMed search was conducted to identify phase III clinical trials published between Jan. 1990 and Aug. 2011, evaluating systemic treatment in MBC patients. Data pertaining to treatment regimens, study endpoints and clinical findings were collected, with a particular focus on progression-based (PB), overall survival (OS), and QoL endpoints. Results: Of 520 publications identified, 122 phase III MBC clinical trials met the inclusion criteria. Of these studies, 98.4% and 95.9% included PB and OS respectively, as clinical endpoints, while QoL was assessed in only 46 (37.7%) studies. While the inclusion of QoL was not associated with the significance of PB results, there was an association between the inclusion of QoL and OS results, with 59% of significant OS studies and 32% of non-significant OS studies including QoL as a clinical endpoint (p=0.016). When stratified by treatment arm, it was found that studies favouring standard therapy were more likely to include QoL (75%, p=0.045), compared to those favouring the intervention (56%), and those without significant differences (32%). Conclusions: Although the importance of QoL is often emphasized in MBC management and treatment decisions, only one-third of identified phase III clinical trials included an assessment of QoL. About half of these trials showed no statistically significant differences in the QoL endpoint; of not, instruments of varying validity were utilized. There needs to be a greater emphasis on the evaluation of QoL, with the use of standard and validated QoL tools in MBC clinical trials, especially as we increasingly focus on progression-based endpoints.

Quality of Life of Patients With Pyoderma Gangrenosum and Hidradenitis Suppurativa

2015 ◽  
Vol 19 (4) ◽  
pp. 391-396 ◽  
Author(s):  
Arielle J. Gerard ◽  
Steven R. Feldman ◽  
Lindsay Strowd
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Pyoderma Gangrenosum ◽  
Hidradenitis Suppurativa ◽  
Measurement Tool ◽  
Clinical Use ◽  
Pubmed Search ◽  
The Impact ◽  
Disease Specific

Background: Pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS) are painful and unsightly dermatologic disorders that have the potential to significantly decrease patients’ quality of life (QOL). Due to the difficulties associated with curing these conditions, QOL improvement is imperative. Objective: To determine if there are PG and HS disease-specific QOL measures and to assess whether QOL is being systematically studied in clinic populations or clinical trials. Methods: A PubMed search was performed to identify QOL studies for patients with PG and HS. Sources from other papers were also utilized. Results: QOL is rarely qualitatively or quantitatively assessed in HS and PG studies. We identified no validated disease-specific QOL measures for either PG or HS. Conclusion: Development of disease-specific QOL indices, clinical use of QOL measurement tool, and formal QOL evaluation in clinical trials would help to define the impact of PG and HS treatment in patients’ lives.

scholarly journals A meta-synthesis of qualitative literature on female chronic pelvic pain for the development of a core outcome set: a systematic review

2021 ◽  
Author(s):  
Vishalli Ghai ◽  
◽  
Venkatesh Subramanian ◽  
Haider Jan ◽  
Ranee Thakar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Pelvic Pain ◽  
Chronic Pelvic Pain ◽  
Qualitative Studies ◽  
Cochrane Central Register ◽  
Core Outcome ◽  
Life Management ◽  
The Impact

Abstract Introduction and hypothesis Qualitative research has an increasing role in the development of core outcome sets (COS) adding patient perspectives to the considerations of core outcomes. We aimed to identify priorities of women with experience of chronic pelvic pain (CPP). Methods The search strategy was a systematic review of qualitative studies identified from Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, EMBASE, MEDLINE and PsycInfo databases. Selection criteria were qualitative studies exploring the experience of women with CPP. Two independent researchers extracted data and summarized findings using thematic analysis. A CERQual assessment was performed to assess the confidence of review findings. Results We identified pertinent issues affecting women with CPP including the lack of holistic care, influence of psychosocial factors and the impact of pain on quality of life. Five meta-themes central to delivering a patient-centred approach were highlighted: acceptance of pain, quality of life, management of CPP, communication and support. Management of CPP was the most commonly reported meta-theme across seven studies and half of studies reported quality of life, management, communication and support. Quality appraisal of included studies identified only a single study that met all CASP (Critical Appraisal Skills Programme) criteria. There was high confidence in the evidence for acceptance of pain, quality of life and communication meta-themes. Conclusion Meta-themes revealed by this review should be considered as a priority and reflected in outcomes reported by future studies evaluating interventions for CPP. In addition, these themes should be considered by clinicians managing women with CPP.

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