Abstract:
:To assess the impact of disease and treatment on patients with advanced non-small cell lung cancer (NSCLC), we set out to determine a clinically meaningful change (CMC) on the Lung Cancer Subscale (LCS) and the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. We used data from Eastern Cooperative Oncology Group study 5592 (E5592), a randomized trial comparing three chemotherapeutic regimens in 599 advanced NSCLC patients. Patients completed the FACT-L at baseline (pretreatment), 6 weeks, 12 weeks, and 6 months. Comparing across baseline performance status (0 vs. 1), prior weight loss (<5% vs. > or = 5%), and primary disease symptoms (< or = 1 vs. >1), LCS and TOI score differences ranged from 2.4 to 3.6 and 6.5 to 9.2, respectively (all Ps <.001). Mean improvement in LCS score from baseline to 12 weeks was 2.4 points in patients who had responded to treatment versus 0.0 points in patients who had progressive disease. Twelve-week LCS change scores for patients progressing early were 3.1 points worse than those of patients progressing later (mean = -1.2 vs.1.9, respectively). Similarly, the average TOI change score from baseline to 12 weeks was -6.1 for patients who had progressive disease versus -0.8 points for patients who had responded to treatment. Twelve-week TOI change scores for patients progressing early (mean = -8.1) were 5.7 points worse than those of patients progressing later (mean = -8.1 vs. -2.4, respectively). Analyses assuming nonrandom missing data resulted in slightly larger differences. Clinically relevant change scores were estimated as two to three points for the LCS and five to seven points for the TOI, setting upper limits for minimal CMCs. These values were comparable to suggested distribution-based criteria of a minimally important difference. These results support use of a two to three point change in the LCS and five to six point change on the TOI of the FACT-L as a CMC, and offer practical direction for inclusion of important patient-based endpoints in lung cancer clinical trials.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Cella D,Eton DT,Fairclough DL,Bonomi P,Heyes AE,Silberman C,Wolf MK,Johnson DHdoi
10.1016/s0895-4356(01)00477-2subject
Has Abstractpub_date
2002-03-01 00:00:00pages
285-95issue
3eissn
0895-4356issn
1878-5921pii
S0895435601004772journal_volume
55pub_type
临床试验,杂志文章,随机对照试验abstract:BACKGROUND AND OBJECTIVE:In 1981, toxic oil syndrome (TOS) appeared in Spain, affecting more than 20,000 persons and causing over 2500 deaths to date. Previous studies have addressed mortality only by gender and age. We analyzed possible prognostic factors in the survival of the cohort. METHODS:The study period was 1 ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(03)00119-7
更新日期:2003-07-01 00:00:00
abstract:OBJECTIVES:Interpretation of clinical research findings using the paradigm of null hypothesis significance testing has a number of limitations. These include arbitrary dichotomization of results, lack of incorporation of study power and prior probability, and the confusing use of conditional probability. This study aim...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2017.08.016
更新日期:2017-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Clinical trials increasingly use results of diagnostic tests as surrogate outcomes. Our objective was to answer the following questions: (1) is the parameter measured by the reference standard a valid surrogate? (2) How does the tests accuracy influence the estimate of the treatment benefit on...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2005.02.024
更新日期:2005-10-01 00:00:00
abstract::A 110-item food frequency questionnaire was tested among 152 community controls of the Kuopio Breast Cancer Study. They completed the questionnaire twice and kept two 7-day diet records at 3-month intervals. The intraclass correlations for nutrients varied from 0.49 (thiamine with supplements) to 0.81 (lactose), and f...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(95)00551-x
更新日期:1996-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Hui and Walter developed a latent class approach to assess the accuracy of a diagnostic procedure when no reference test is available. Our objective was to compare sensitivity and specificity estimates obtained with this reference-free approach and standard approaches, and to examine how and wh...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2004.10.021
更新日期:2005-07-01 00:00:00
abstract:OBJECTIVES:Timely and comprehensive reporting of clinical trial results builds the backbone of evidence-based medicine and responsible research. The proportion of timely disseminated trial results can inform alternative national and international benchmarking of university medical centers (UMCs). STUDY DESIGN AND SETT...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2019.06.002
更新日期:2019-11-01 00:00:00
abstract:OBJECTIVE:Conduct a systematic review of pediatric randomized controlled trials (RCTs) published in high-impact journals to assess the reporting of primary outcomes and the psychometric properties of their measures. STUDY DESIGN AND SETTING:Systematic review with screening and simultaneous data extraction conducted by...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2016.09.003
更新日期:2017-01-01 00:00:00
abstract:OBJECTIVE:To assess the extent to which meta-analysis publications of drugs and biologics focus on specific named agents or even only a single agent, and identify characteristics associated with such focus. STUDY DESIGN AND SETTING:We evaluated 499 articles with meta-analyses published in 2010 and estimated how many d...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2012.10.014
更新日期:2013-04-01 00:00:00
abstract:OBJECTIVES:To present a new method to estimate a "minimal important change" (MIC) of health-related quality of life (HRQOL) scales, based on predictive modeling, and to compare its performance with the MIC based on receiver operating characteristic (ROC) analysis. To illustrate how the new method deals with variables t...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2015.03.015
更新日期:2015-12-01 00:00:00
abstract:INTRODUCTION:Weight loss interventions often present small mean weight changes over time, despite the fact that a substantial proportion of the participants lost more weight. This effect is often leveled out by the substantial proportion of participants who gained weight during the trial. The aim of this study is to id...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.jclinepi.2014.03.007
更新日期:2014-08-01 00:00:00
abstract::We assessed the relative responsiveness of generic and specific quality of life instruments in 43 randomized controlled trials that compared head-to-head 31 generic and 84 specific instruments. Using weighted effect size as the metric of responsiveness, we assessed the impact of instrument type, disease category, and ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/s0895-4356(02)00537-1
更新日期:2003-01-01 00:00:00
abstract::Time to revision is an important criterion describing the quality of implants in total joint surgery. Estimates of failure probabilities are required to inform a patient about the risk of suffering a reoperation. Also, regression models are used for comparing different prosthesis designs. Typically, patients dying bef...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(01)00371-7
更新日期:2001-10-01 00:00:00
abstract:OBJECTIVES:To assess how trial information reported in conference abstracts differs to their subsequent full publication. METHODS:Randomized trials reported at the American Society of Clinical Oncology conference (1992) were identified. CENTRAL and PubMed (December 2002) were searched to identify corresponding full pu...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.09.016
更新日期:2006-07-01 00:00:00
abstract:OBJECTIVES:A key systematic review (SR) methodology is comprehensive searching. The Drug Effectiveness Review Project (DERP) SRs search US Food and Drug Administration (FDA) documents to identify unpublished evidence. This study evaluates the success of those efforts. STUDY DESIGN AND SETTING:We examined DERP reports ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2013.05.006
更新日期:2013-10-01 00:00:00
abstract::The Indonesian Food and Drug Agency began to evaluate drug applications in the early 1970s through an Advisory Committee. This was in response to the perestroika-like policy applied to our drug industry; nowadays there are more than 300 drug companies formulating some 13,5600 drug products. During 1977-1988, 603 drugs...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90111-l
更新日期:1991-01-01 00:00:00
abstract::The objective of this study was to assess the effects of a multicomponent intervention on private pharmacy practice. From 641 private pharmacies in Hanoi, 68 pharmacies were randomly selected and matched into 34 pairs. Each pair consisted of a control and an intervention pharmacy. Three interventions were applied sequ...
journal_title:Journal of clinical epidemiology
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0895-4356(02)00458-4
更新日期:2002-11-01 00:00:00
abstract::Results from pragmatic trials should reflect the comparative treatment effects encountered in patients in real-life clinical practice to guide treatment decisions. Therefore, pragmatic trials should focus on outcomes that are relevant to patients, clinical practice, and treatment choices. This sixth article in the ser...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2016.12.022
更新日期:2017-10-01 00:00:00
abstract:OBJECTIVE:Optimism bias refers to unwarranted belief in the efficacy of new therapies. We assessed the impact of optimism bias on a proportion of trials that did not answer their research question successfully and explored whether poor accrual or optimism bias is responsible for inconclusive results. STUDY DESIGN:Syst...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2010.09.007
更新日期:2011-06-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to develop an index derived from the Medication Appropriateness Index (MAI) items that is suited for clinical studies evaluating appropriateness of psychotropic drug use (PDU) for neuropsychiatric symptoms (NPS) in patients with dementia in nursing homes and to test its reliability ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2015.03.012
更新日期:2015-08-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Methods to identify studies for systematic reviews of diagnostic accuracy are less well developed than for reviews of intervention studies. This study assessed (1) the sensitivity and precision of five published search strategies and (2) the reliability and accuracy of reviewers screening the ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2004.09.011
更新日期:2005-05-01 00:00:00
abstract:OBJECTIVES:To determine what criteria researchers use to assess whether the estimates of effect of an intervention on a dichotomous outcome are different when obtained using different study designs. STUDY DESIGN AND SETTING:Scoping review of the literature. We included studies of dichotomous outcomes in which authors ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2016.02.001
更新日期:2016-07-01 00:00:00
abstract::This paper focuses on the appropriateness of outcome measures to evaluate trauma care. The preventable death rate (PDR), based on the study of deceased patients only, has been the traditional measure of the impact of trauma care on improving the survival of patients with severe trauma. Another measure frequently used ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(90)90125-9
更新日期:1990-01-01 00:00:00
abstract::The similarity in meaning assigned to response choice labels from the SF-36 Health Survey (SF-36) was evaluated across countries. Convenience samples of judges (range, 10 to 117; median = 48) from 13 countries rated translations of response choice labels, using a variation of the Thurstone method of equal appearing in...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(98)00084-5
更新日期:1998-11-01 00:00:00
abstract::Core outcome sets (COSs) are agreed-on standardized sets of outcomes that should be minimally measured in all trials of a given disease. To enhance the uptake of COSs in trials, their generalizability should be increased by a change in the number and diversity of stakeholders involved in their development. Also, their...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2020.01.004
更新日期:2020-09-01 00:00:00
abstract:OBJECTIVES:The massive growth in the publication of meta-analyses may cause redundancy and wasted efforts. We performed a metaepidemiologic study to evaluate the extent of potential redundancy in published meta-analyses in genetic epidemiology. STUDY DESIGN AND SETTING:Using a sample of 38 index meta-analyses of genet...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2020.05.035
更新日期:2020-11-01 00:00:00
abstract:OBJECTIVES:To illustrate how multiple hypotheses testing can produce associations with no clinical plausibility. STUDY DESIGN AND SETTING:We conducted a study of all 10,674,945 residents of Ontario aged between 18 and 100 years in 2000. Residents were randomly assigned to equally sized derivation and validation cohort...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2006.01.012
更新日期:2006-09-01 00:00:00
abstract:OBJECTIVE:To describe the pain decrease considered as clinically relevant when designing a trial and reporting its results. METHODS:A systematic review of the literature in MEDLINE was conducted to select randomized controlled trials (RCTs) with pain as a primary outcome. Data extracted included the definition (terms ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2010.06.008
更新日期:2011-05-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to reanalyze and reinterpret data obtained in Paracetamol in Acute Low Back Pain (PACE), the first large randomized controlled trial evaluating the efficacy of paracetamol in acute low back pain, to assess the inferential reproducibility of the original conclusions. STUDY DESIGN AN...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.jclinepi.2020.01.010
更新日期:2020-05-01 00:00:00
abstract:OBJECTIVE:Loss to follow-up threatens internal and external validity yet little research has examined ways to limit participant attrition. We conducted a systematic review of studies with a primary focus on strategies to retain participants in health care research. STUDY DESIGN AND SETTINGS:We completed searches of Pu...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2006.11.023
更新日期:2007-08-01 00:00:00
abstract::Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders. There continues to be a need for community-based research into this condition. Unfortunately, response rates in community-based IBS surveys have typically been very low. In this study, we explore the use of incentives and multiple-res...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(02)00586-3
更新日期:2003-03-01 00:00:00