Abstract:
:With the growth of patient-reported outcome (PRO) measurement, questions arise regarding how copyright protection applies to PRO instruments in general and to their translations in particular. The main objectives of this reflection paper are: 1) to help authors of PRO instruments understand basic rules of intellectual property and copyright that protect the integrity of their instruments and derivatives; and 2) to provide recommendations to authors and users of PRO instruments to prevent misuse or abuse.National laws on intellectual property (IP) and the international Berne Convention fully apply to PRO instruments since they are creations of the mind. Therefore, the copyright holder / owner / claimant of a PRO instrument, i.e., the person or legal entity who owns the copyright of the instrument, is granted exclusive rights that are divided into two main categories: moral and economic rights. Moral rights are: 1) the right of attribution (or right of paternity), i.e., the right to claim authorship of the work, 2) the right against false attribution, and 3) the right of integrity, i.e., the right to object to any mutilation, deformation or modification of the work. Economic rights represent the exclusive rights of the author to make or authorize reproduction, development of derivative works, distribution and communication to the public. In other words, the PRO instrument's copyright holder controls access (distribution, reproduction), and authorizes all derivative works, i.e., adaptations (e.g., electronic formats), modifications (e.g., shorter versions), and translations. Hence, the access to and use of an original PRO instrument and its derivatives in any kind of research should always be associated with the identification of its copyright holder. However, in some cases, this identification may be challenging, in particular when copyright ownership is not clearly defined. To prevent ownership conflicts as well as misuse or abuse of PRO instruments, the ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) provides recommendations to authors of PRO instruments and their users. In particular, the TCA-SIG recommends that the ownership of PRO instruments and their derivatives should be defined from the beginning (i.e., from the development of the instrument) and along the life cycle of the instrument between all parties involved. These recommendations apply not only to PRO instruments but also to all the other clinical outcome assessments (COAs), since they are also creations of the mind.
journal_name
Health Qual Life Outcomesjournal_title
Health and quality of life outcomesauthors
Anfray C,Arnold B,Martin M,Eremenco S,Patrick DL,Conway K,Acquadro C,ISOQOL Translation and Cultural Special Interest Group (TCA-SIG).doi
10.1186/s12955-018-1050-4subject
Has Abstractpub_date
2018-12-05 00:00:00pages
224issue
1issn
1477-7525pii
10.1186/s12955-018-1050-4journal_volume
16pub_type
信件abstract:OBJECTIVE:We compare the reliability and validity of the Short Form 36 (version 1, SF-36) and the Short Form 12 (version 1, SF-12) in adolescence, the period of life when a child develops into an adult, i.e., the period from puberty to maturity terminating legally at the age of majority (10-19 years), thus supplying ev...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-020-01605-8
更新日期:2020-11-09 00:00:00
abstract:BACKGROUND:Health-Related Quality of Life (HRQoL) is an important endpoint in oncology clinical trials aiming to investigate the clinical benefit of new therapeutic strategies for the patient. However, the longitudinal analysis of HRQoL remains complex and unstandardized. There is clearly a need to propose accessible s...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-014-0192-2
更新日期:2014-12-31 00:00:00
abstract:BACKGROUND:Endometrial cancer survivors are at an increased risk of poor quality of life outcomes. Physical activity is positively associated with general quality of life in this population, however, little is known about how changes in physical activity may be associated with changes in specific aspects of quality of ...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章,随机对照试验
doi:10.1186/s12955-019-1154-5
更新日期:2019-05-27 00:00:00
abstract:BACKGROUND:Spanish is one of the five most spoken languages in the world. There is currently no published Spanish version of the Örebro Musculoskeletal Pain Questionnaire (OMPQ). The aim of the present study is to describe the process of translating the OMPQ into Spanish and to perform an analysis of reliability, inter...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-014-0157-5
更新日期:2014-10-29 00:00:00
abstract:PURPOSE:Chronic kidney disease (CKD) induces frailty and worsens quality of life (QOL), even in the early stages of the disease and in young patients. However, there is a lack of knowledge about the relationship between frailty and QOL in CKD patients. Thus, we investigated this relationship in a sample of CKD patients...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/1477-7525-12-27
更新日期:2014-02-28 00:00:00
abstract:BACKGROUND:The Multidimensional Scale of Perceived Social Support (MSPSS) is a short instrument, developed to assess perceived social support. The original English version has been widely used. The original scale has demonstrated satisfactory psychometric properties in different settings, but no validated Swedish versi...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/1477-7525-11-168
更新日期:2013-10-10 00:00:00
abstract:OBJECTIVE:Seasonal changes in mood and behavior are common in a general population, being of relevance to public health. We wanted to analyze whether the HRQoL is associated with the seasonal changes in mood and behavior. Because the shortage of exposure to daylight or artificial bright light has been linked to the occ...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/1477-7525-6-56
更新日期:2008-08-01 00:00:00
abstract:PURPOSE:The present study aimed to determine the effect of demographic characteristics, occupation, anthropometric indices, and leisure-time physical activity levels on coronary risk and health-related quality of life among military police officers from the State of Santa Catarina, Brazil. METHODS:The sample included ...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/1477-7525-12-60
更新日期:2014-04-27 00:00:00
abstract:BACKGROUND:Studies have been rarely conducted to provide a comprehensive perspective of pregnant women with the intention to investigate the relationships between periodontal conditions and oral health-related quality of life (OHRQoL). As such, this study aimed to describe the OHRQoL of pregnant women in Shanghai, Chin...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-015-0267-8
更新日期:2015-05-28 00:00:00
abstract::A response to Marci et al. 'Procreative sex in infertile couples: the decay of pleasure?'This is a reply to http://www.hqlo.com/content/pdf/1477-7525-11-52.pdf. ...
journal_title:Health and quality of life outcomes
pub_type: 评论,信件
doi:10.1186/1477-7525-11-52
更新日期:2013-04-11 00:00:00
abstract:BACKGROUND:Little is known about the association between diabetes and health related quality of life (HRQL) in lower-middle income countries. This study aimed to investigate HRQL among individuals with and without diabetes in Bangladesh. METHODS:The analysis is based on data of a case-control study, including 591 pati...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-016-0530-7
更新日期:2016-09-13 00:00:00
abstract:BACKGROUND:Patient-reported outcome measures have become a well-recognised part of outcome assessment in orthopaedic surgery. These questionnaires claim to measure joint-specific dimensions like pain, function in activities of daily living, joint awareness or stiffness. Interference of the patient's psychological statu...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/1477-7525-11-64
更新日期:2013-04-19 00:00:00
abstract:BACKGROUND:Psychometric evidence is necessary to establish scientific integrity and clinical usefulness of translations and cultural adaptations of the Stroke-Specific Quality of Life (SS-QoL) scale. However, the limited evidence on psychometrics of Yoruba version of SS-QoL 2.0 (SS-QoL(Y)) is a significant shortcoming....
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-017-0775-9
更新日期:2017-10-19 00:00:00
abstract:BACKGROUND:To assess QOL of patients with stroke in comparison to other groups (caregivers and CHF patients), to identify which items of QOL are more affected on each group and what is the functional profile of patients with stroke. METHODS:Consecutive stroke or congestive heart failure (CHF) patients were evaluated a...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/1477-7525-9-65
更新日期:2011-08-10 00:00:00
abstract:BACKGROUND:The EQ-5D health-related quality of life instrument comprises a health state classification (health problems by severity in five domains), followed by an evaluation using a visual analogue scale (VAS). Despite the EQ-5D's use in health technology assessment and as a patient-reported outcome measure (PROM), t...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/1477-7525-11-155
更新日期:2013-09-13 00:00:00
abstract:BACKGROUND:The West-Haven Multidimensional Pain Inventory (MPI) can be used to describe behavioural and psychosocial consequences of long-term pain but little is known about how MPI items and MPI subgroups relate to goals that patients find important in rehabilitation. Life satisfaction measured by the LiSat-11 checkli...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/1477-7525-6-70
更新日期:2008-09-23 00:00:00
abstract:BACKGROUND:The age limit for some adult asthma clinical trials has recently been lowered to 12 years. In this study we have made minor modifications to the standardised version of the adult Asthma Quality of Life Questionnaire (AQLQ(S)) to make it valid for patients 12 years and older (AQLQ12+). METHODS:We have used t...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/1477-7525-3-58
更新日期:2005-09-16 00:00:00
abstract:BACKGROUND:The Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) are patient-reported outcome measures developed to evaluate efficacy in clinical trials and clinical practice. The ESD is a daily electronic diary assessing symptom severity; the EIS is a weekly electronic diary assessing symptom impa...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-020-01579-7
更新日期:2021-01-06 00:00:00
abstract:BACKGROUND:Health-related quality of life (HRQOL) is an important outcome indicator for chronic disease, and particularly in the absence of biological markers for illness, such as with irritable bowel syndrome (IBS). The aims of this study were to develop and evaluate a new IBS-specific HRQOL instrument (IBS-HR-QOL). ...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-016-0423-9
更新日期:2016-02-17 00:00:00
abstract:INTRODUCTION:The primary objective of this sub analysis of the CONOCES study was to analyse outcomes in terms of mortality rates, quality of life and degree of autonomy over the first year in patients admitted to stroke units in Spain. The secondary objective was to identify the factors determining good prognosis. MET...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-015-0230-8
更新日期:2015-03-17 00:00:00
abstract:BACKGROUND:The proportion of people living to a very old age is continuously increasing. One of the possibilities explored in policies and services to meet this health and societal challenge is to encourage the very old to continue living at home. This initiative is in line with the wishes of most elderly people. Howev...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-020-01376-2
更新日期:2020-05-07 00:00:00
abstract:BACKGROUND:NAFLD impacts patient reported outcomes (PROs). Our aim was to assess the impact of NAFLD on patients' HRQOL. METHODS:National Health and Nutrition Examination Survey (NHANES) 2001-2011 data were used to identify adult patients with NAFLD [Fatty Liver Index (FLI) > 60 in absence of other liver disease and e...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-016-0420-z
更新日期:2016-02-09 00:00:00
abstract:BACKGROUND:Providers and patients have called for improved understanding of the health care requirements of adults with sickle cell disease (SCD) and have identified the need for a systematic, reliable and valid method to document the patient-reported outcomes (PRO) of adult SCD care. To address this need, the Adult Si...
journal_title:Health and quality of life outcomes
pub_type: 临床试验,杂志文章
doi:10.1186/s12955-014-0125-0
更新日期:2014-08-22 00:00:00
abstract:BACKGROUND:This study examined sex-specific differences in physical health-related quality of life (HRQoL) across subgroups of metabolic health and obesity. We specifically asked whether (1) obesity is related to lower HRQoL independent of metabolic health status and potential confounders, and (2) whether associations ...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-017-0688-7
更新日期:2017-06-10 00:00:00
abstract:BACKGROUND:The Pain Catastrophizing Scale (PCS) is a widely used self-report tool to evaluate pain related catastrophizing. The PCS was developed using classical test theory and has been shown to be psychometrically sound among various populations. However, it's current three subscales are rarely used in clinical pract...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-020-01346-8
更新日期:2020-05-07 00:00:00
abstract:OBJECTIVE:End-stage renal disease (ESRD) leads to renal replacement therapy and certainly has an impact on patients' health-related quality of life (HRQoL). This study aimed to review and compare the HRQoL between peritoneal dialysis (PD) and hemodialysis (HD) patients using the 36-Item Short Form Health Survey (SF-36)...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章,meta分析
doi:10.1186/s12955-020-01449-2
更新日期:2020-06-18 00:00:00
abstract:BACKGROUND:Many patients with cancer experience depression and anxiety, and an associated decrease in quality of life (QOL) during radiation therapy (RT). The main objective of the study was to determine the benefits of psychosocial interventions for cancer patients who received RT. METHODS:Patients with cancer (n = 1...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章,随机对照试验
doi:10.1186/1477-7525-11-121
更新日期:2013-07-17 00:00:00
abstract:BACKGROUND:Porphyria cutanea tarda (PCT) is a rare, photosensitive disease characterized by skin fragility and blistering on sun-exposed areas. There is little previous research on how this condition affects health-related quality of life (HRQoL) and to the best of our knowledge this is the largest sample of PCT patien...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-020-01328-w
更新日期:2020-03-30 00:00:00
abstract:BACKGROUND:Parents often experience stress-related complications when their child requires blood and marrow transplant (BMT). Previous studies have described the emotional toll BMT places on parents during the acute phase of care and within the context of clinical complications. In this paper we introduce the Parent Im...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-015-0240-6
更新日期:2015-04-09 00:00:00
abstract:BACKGROUND:Measuring quality of life (QOL) in a population is important for the predictions of health and social care needs. In Pakistan, health related quality of life data exist but there are no quality of life data of general population. In this study, quality of life was assessed among the Pakistani general populat...
journal_title:Health and quality of life outcomes
pub_type: 杂志文章
doi:10.1186/s12955-018-1065-x
更新日期:2019-01-14 00:00:00