Abstract:
BACKGROUND:The use of health-related quality of life (HRQoL) as an endpoint in cancer clinical trials is growing rapidly. Hence, research into the statistical approaches used to analyze HRQoL data is of major importance, and could lead to a better understanding of the impact of treatments on the everyday life and care of patients. Amongst the models that are used for the longitudinal analysis of HRQoL, we focused on the mixed models from item response theory, to directly analyze raw data from questionnaires. METHODS:We reviewed the different item response models for ordinal responses, using a recent classification of generalized linear models for categorical data. Based on methodological and practical arguments, we then proposed a conceptual selection of these models for the longitudinal analysis of HRQoL in cancer clinical trials. RESULTS:To complete comparison studies already present in the literature, we performed a simulation study based on random part of the mixed models, so to compare the linear mixed model classically used to the selected item response models. As expected, the sensitivity of the item response models to detect random effects with lower variance is better than that of the linear mixed model. We then used a cumulative item response model to perform a longitudinal analysis of HRQoL data from a cancer clinical trial. CONCLUSIONS:Adjacent and cumulative item response models seem particularly suitable for HRQoL analysis. In the specific context of cancer clinical trials and the comparison between two groups of HRQoL data over time, the cumulative model seems to be the most suitable, given that it is able to generate a more complete set of results and gives an intuitive illustration of the data.
journal_name
BMC Med Res Methodoljournal_title
BMC medical research methodologyauthors
Barbieri A,Peyhardi J,Conroy T,Gourgou S,Lavergne C,Mollevi Cdoi
10.1186/s12874-017-0410-9subject
Has Abstractpub_date
2017-09-26 00:00:00pages
148issue
1issn
1471-2288pii
10.1186/s12874-017-0410-9journal_volume
17pub_type
杂志文章,评审abstract:BACKGROUND:Multi-centre randomized controlled clinical trials play an important role in modern evidence-based medicine. Advantages of collecting data from more than one site are numerous, including accelerated recruitment and increased generalisability of results. Mixed models can be applied to account for potential cl...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-018-0602-y
更新日期:2018-11-29 00:00:00
abstract:BACKGROUND:Available methods for the joint modelling of longitudinal and time-to-event outcomes have typically only allowed for a single longitudinal outcome and a solitary event time. In practice, clinical studies are likely to record multiple longitudinal outcomes. Incorporating all sources of data will improve the p...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-016-0212-5
更新日期:2016-09-07 00:00:00
abstract:BACKGROUND:Sleeping under a long-lasting insecticidal net (LLIN) is recommended for all pregnant women in sub-Saharan Africa, due to the high prevalence of malaria infection and its associated complications in the region. Despite this, LLIN use has still remained sub-optimal among pregnant women in Maiduguri, Nigeria. ...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-019-0803-z
更新日期:2019-07-18 00:00:00
abstract:BACKGROUND:Predicting survival of recipients after liver transplantation is regarded as one of the most important challenges in contemporary medicine. Hence, improving on current prediction models is of great interest.Nowadays, there is a strong discussion in the medical field about machine learning (ML) and whether it...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-020-01153-1
更新日期:2020-11-16 00:00:00
abstract:BACKGROUND:When investigating subgroup effects in meta-analysis, it is unclear whether accounting in meta-regression for between-trial variation in treatment effects, but not between-trial variation in treatment interaction effects when such effects are present, leads to biased estimates, coverage problems, or wrong st...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-019-0831-8
更新日期:2019-10-26 00:00:00
abstract:BACKGROUND:Cancer relapses may be useful to predict the risk of death. To take into account relapse information, the Landmark approach is popular. As an alternative, we propose the joint frailty model for a recurrent event and a terminal event to derive dynamic predictions of the risk of death. METHODS:The proposed pr...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-015-0018-x
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND:Diet plays an important role in chronic disease, and the use of dietary pattern analysis has grown rapidly as a way of deconstructing the complexity of nutritional intake and its relation to health. Pattern analysis methods, such as principal component analysis (PCA), have been used to investigate various di...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-018-0585-8
更新日期:2018-10-29 00:00:00
abstract:BACKGROUND:Social-environmental data obtained from the US Census is an important resource for understanding health disparities, but rarely is the full dataset utilized for analysis. A barrier to incorporating the full data is a lack of solid recommendations for variable selection, with researchers often hand-selecting ...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-020-01183-9
更新日期:2020-12-10 00:00:00
abstract:BACKGROUND:A frequently used statistic for testing homogeneity in a meta-analysis of K independent studies is Cochran's Q. For a standard test of homogeneity the Q statistic is referred to a chi-square distribution with K-1 degrees of freedom. For the situation in which the effects of the studies are logarithms of odds...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-015-0034-x
更新日期:2015-06-10 00:00:00
abstract:BACKGROUND:Spiritual care is defined as recognizing and responding to the needs of the human spirit when the individual is facing trauma, illness, or sadness. Providing spiritual care is one of the core aspects of holistic care, as it is significantly associated with patients' quality of life. The provision of optimal ...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-019-0662-7
更新日期:2019-01-23 00:00:00
abstract:BACKGROUND:Chronic Obstructive Pulmonary Disease (COPD) is currently the fifth leading cause of death in Australia, and there are marked differences in mortality trends between men and women. In this study, we have sought to model and forecast age related changes in COPD mortality over time for men and women separately...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-12-17
更新日期:2012-02-21 00:00:00
abstract:BACKGROUND:Disease registers aim to collect information about all instances of a disease or condition in a defined population of individuals. Traditionally methods of operating disease registers have required that notifications of cases be identified by unique identifiers such as social security number or national iden...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-3-1
更新日期:2003-01-06 00:00:00
abstract:BACKGROUND:This paper discusses whether baseline demographic, socio-economic, health variables, length of follow-up and method of contacting the participants predict non-response to the invitation for a second assessment of lifestyle factors and body weight in the European multi-center EPIC-PANACEA study. METHODS:Over...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-12-148
更新日期:2012-09-24 00:00:00
abstract:BACKGROUND:Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, is a rare disease with extreme between-subject variability, especially with respect to rate of disease progression. This makes modelling a subject's disease progression, which is measured by the ALS Functional Rating Scale (ALSFRS), ver...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-018-0479-9
更新日期:2018-02-06 00:00:00
abstract:BACKGROUND:Meta-analysis typically involves combining the estimates from independent studies in order to estimate a parameter of interest across a population of studies. However, outliers often occur even under the random effects model. The presence of such outliers could substantially alter the conclusions in a meta-a...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-11-19
更新日期:2011-02-16 00:00:00
abstract:BACKGROUND:Typically, randomization software should allow users to exert control over the different aspects of randomization including block design, provision of unique identifiers and control over the format and type of program output. While some of these characteristics have been addressed by available software, none...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-4-26
更新日期:2004-11-09 00:00:00
abstract:BACKGROUND:Patient-reported outcome (PRO) measures play a key role in the advancement of patient-centered care research. The accuracy of inferences, relevance of predictions, and the true nature of the associations made with PRO data depend on the validity of these measures. Errors inherent to self-report measures can ...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-016-0161-z
更新日期:2016-05-26 00:00:00
abstract:BACKGROUND:The Anglia Menorrhagia Education Study (AMES) is a randomized controlled trial testing the effectiveness of an education package applied to general practices. Binary data are available from two sources; general practitioner reported referrals to hospital, and referrals to hospital determined by independent a...
journal_title:BMC medical research methodology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1186/1471-2288-3-17
更新日期:2003-09-24 00:00:00
abstract:BACKGROUND:We would expect information on adverse drug reactions in randomised clinical trials to be easily retrievable from specific searches of electronic databases. However, complete retrieval of such information may not be straightforward, for two reasons. First, not all clinical drug trials provide data on the fre...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-1-7
更新日期:2001-01-01 00:00:00
abstract:BACKGROUND:The weighted estimators generally used for analyzing case-cohort studies are not fully efficient and naive estimates of the predictive ability of a model from case-cohort data depend on the subcohort size. However, case-cohort studies represent a special type of incomplete data, and methods for analyzing inc...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-12-24
更新日期:2012-03-09 00:00:00
abstract:BACKGROUND:Glaucoma is a leading cause of avoidable blindness worldwide. Open angle glaucoma is the most common type of glaucoma. No randomised controlled trials have been conducted evaluating the effectiveness of glaucoma screening for reducing sight loss. It is unclear what the most appropriate intervention to be eva...
journal_title:BMC medical research methodology
pub_type: 临床试验,杂志文章
doi:10.1186/1471-2288-11-54
更新日期:2011-04-21 00:00:00
abstract:BACKGROUND:In order to accurately measure and monitor levels of moderate-to-vigorous physical activity (MVPA) and sedentary behaviour (SB) in older adults, cost efficient and valid instruments are required. To date, the International Physical Activity Questionnaire (IPAQ) has not been validated with older adults (aged ...
journal_title:BMC medical research methodology
pub_type: 杂志文章,多中心研究
doi:10.1186/s12874-018-0642-3
更新日期:2018-12-22 00:00:00
abstract:BACKGROUND:Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes ...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-020-01019-6
更新日期:2020-05-25 00:00:00
abstract:BACKGROUND:Diagnostic tests are performed in a subset of the population who are at higher risk, resulting in undiagnosed cases among those who do not receive the test. This poses a challenge for estimating the prevalence of the disease in the study population, and also for studying the risk factors for the disease. ME...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-017-0447-9
更新日期:2017-12-12 00:00:00
abstract:BACKGROUND:There is increasing awareness that meta-analyses require a sufficiently large information size to detect or reject an anticipated intervention effect. The required information size in a meta-analysis may be calculated from an anticipated a priori intervention effect or from an intervention effect suggested b...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-9-86
更新日期:2009-12-30 00:00:00
abstract:BACKGROUND:There is analytical potential for multiple cause of death data collected from death certificates. This study examines relationships of multiple causes of death as a function of factors available on the death certificate (demographics of decedent, place of death, type of certifier, disposal method, whether an...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-5-4
更新日期:2005-01-17 00:00:00
abstract:BACKGROUND:The mechanisms and pathways to impacts from public health research in the UK have not been widely studied. Through the lens of one funder (NIHR), our aims are to map the diversity of public health research, in terms of funding mechanisms, disciplinary contributions, and public health impacts, identify exampl...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-020-0905-7
更新日期:2020-02-19 00:00:00
abstract:BACKGROUND:In a random effects meta-analysis model, true treatment effects for each study are routinely assumed to follow a normal distribution. However, normality is a restrictive assumption and the misspecification of the random effects distribution may result in a misleading estimate of overall mean for the treatmen...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-017-0376-7
更新日期:2017-07-19 00:00:00
abstract:BACKGROUND:To describe how frequently harm is reported in the abstract of high impact factor medical journals. METHODS: DESIGN AND POPULATION:We carried out a blinded structured review of a random sample of 363 Randomised Controlled Trials (RCTs) carried out on human beings, and published in high impact factor medica...
journal_title:BMC medical research methodology
pub_type: 信件,评审
doi:10.1186/1471-2288-8-14
更新日期:2008-03-27 00:00:00
abstract:BACKGROUND:Recruitment to health research remains a major challenge. Innovation is required to meet policy commitments to help patients take part in health research. One innovation that may help meet those policy goals is the development of 'consent to contact' systems, where people give generic consent to be contacted...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/s12874-019-0843-4
更新日期:2019-10-22 00:00:00