SynthesisPharmacy world & science : PWS2008
Measuring health-related quality of life in drug clinical trials: is it given due importance?
Synthesis in Pharmacy world & science : PWS, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The relationship between health literacy and quality of life: a systematic review and meta-analysis.Health and quality of life outcomes · 2018Pooled it
- Systematic review reveals limitations of studies evaluating health-related quality of life after potentially curative treatment for esophageal cancer.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2013Pooled it
- The relationships between quality of life with health literacy, social support and resilience in older stroke survivors: A structural equation model.Nursing open · 2024Article
- An observational time-series study on the behavioral effects of adjunctive artisanal cannabidiol use by adults with treatment resistant epilepsies.BMC neurology · 2024Observational
- A Cross-Sectional, Multicentric, Disease-Specific, Health-Related Quality of Life Study in Greek Transfusion Dependent Thalassemia Patients.Healthcare (Basel, Switzerland) · 2024Article
- A structural equation model linking health literacy, self efficacy and quality of life in adults with coronary heart disease.BMC cardiovascular disorders · 2022Article
- Psychometric validation of the French self and proxy versions of the PedsQL™ 4.0 generic health-related quality of life questionnaire for 8-12 year-old children.Health and quality of life outcomes · 2021Article
- Psychological Distress and Health-Related Quality of Life in Public Sector Personnel.International journal of environmental research and public health · 2021Article
- Correlation between Health Literacy and Quality of Life in Iranian Menopausal Women.Journal of menopausal medicine · 2020Article
- Health-related quality of life in hepatitis C patients who achieve sustained virological response to direct-acting antivirals: a comparison with the general population.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2019Article
- CIS-based registration of quality of life in a single source approach.BMC medical informatics and decision making · 2011Article
- Health-related Quality of Life of Nurses Working in Tertiary Care Hospital of Karachi.Pakistan journal of medical sciencesArticle
- Hepatitis C Virus Infection and the New Therapeutical Approach.Current health sciences journalArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aim of the reviewEfficacy estimations of drug clinical trials have been based on clinical measurements and survival rates. However, advances in psychometric techniques have allowed to incorporate a new dimension based on quality of life. Questionnaires aimed at measuring patients' health status outlook, now enable us to quantify the loss of quality of life caused by disease and the improvement that can be achieved by pharmacological treatments. The Aim of this study is to make a quantitative evaluation of the use of health related quality of life (HRQL) measures in drug clinical trials.
methodsA systematic review was performed, in duplicate, of the five journals with highest contribution to the ACP Journal Club, i.e. New England Journal of Medicine, JAMA, The Lancet, Annals of Internal Medicine and the British Medical Journal. HRQL measures were evaluated in published articles referring to drug clinical trials.
resultsWe identified 193 articles that reported the results of clinical trials, of which 28 included QOL measures as secondary end points and two as primary end points: in total, these comprised 16% of the articles analysed. Discussion Without considering the relevance of HRQL measures as a tool in the allocation of resources, it should be included as a health outcome dimension in drug clinical trials. The absence of this evaluation in studies about chronic diseases that affects patients' daily life activities would not be justified.
conclusionsHRQL measures are not used on a regular basis in drug clinical trials that are reported in the relevant literature. Systematic incorporation of QOL measures into clinical trials would make it possible to measure the benefit obtained from drug treatments taking into account the patients' perceptions. Moreover, it would encourage the development of prospective cost-effectiveness studies with patient recorded data in the context of clinical trials. Our findings have a direct impact on practice. Being conscious of the low use of HRQL in clinical trials, it could contribute to increase the demand for these measures by health care professionals. The manuscript is also a useful tool to identify where basic concepts about HRQL measures can be found.
Indexed as
Identifiers
17721699What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.