Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers.
Purpose: To assess the patterns of, and trends over time in, health-related quality of life (HRQL) reporting in randomized controlled trials (RCTs).Methods: The English-language literature of RCTs published in 2002-2008 was identified using Medline, Embase, and Healthstar databases, in addition to t...
| Publicado en: | Quality of Life Research Vol. 20; no. 5; pp. 653 - 665 |
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| Autores principales: | , , , , , , , , , , , , , , , |
| Formato: | research Journal Article |
| Publicado: |
Springer Nature
Jun2011
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104658636&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104658636 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 09629343 GPQ jtl: Quality of Life Research issn: 09629343 maglogo: N pubinfo: dt: Jun2011 vid: 20 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 104658636 NLM21110123 2011212231 10.1007/s11136-010-9793-3 NLM21110123 104658636 ppf: 653 ppct: 12 formats: fmt: @attributes: type: P tig: atl: Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers. aug: au: Brundage M Bass B Davidson J Queenan J Bezjak A Ringash J Wilkinson A Feldman-Stewart D Brundage, Michael Bass, Brenda Davidson, Judith Queenan, John Bezjak, Andrea Ringash, Jolie Wilkinson, Anna Feldman-Stewart, Deb affil: Department of Oncology, Queen's University, Kingston, Ontario, Canada sug: subj: Clinical Trials Practice Patterns Quality of Life Psychosocial Factors Research, Medical Methods Self Report Treatment Outcomes Adaptation, Psychological Chi Square Test Confidence Intervals Resource Databases Stress, Psychological Time ab: Purpose: To assess the patterns of, and trends over time in, health-related quality of life (HRQL) reporting in randomized controlled trials (RCTs).Methods: The English-language literature of RCTs published in 2002-2008 was identified using Medline, Embase, and Healthstar databases, in addition to the Cochrane Clinical Trials Registry. Eligible trials were phase III studies that included an HRQL outcome. Data were abstracted on eight outcomes derived from previously recommended quality standards for reporting HRQL, and on four outcomes describing how HRQL data are presented in RCT reports. Two readers examined each article; discrepancies were resolved through discussion and third review if required.Results: A sample of 794 RCTs was identified. HRQL was a primary outcome in 25.4% (200/794). One hundred and ten RCTs (14%) used "supplementary" reports (separate from the first publication) to report HRQL findings. The proportion of RCTs that met the eight quality indicators ranged from 15% (HRQL used in the calculation of sample size) to 81% (reporting instrument validity). RCTs with HRQL as a primary outcome or with a supplementary report had higher concordance on the quality measures. Reporting improved on many indicators over time. Substantive variation in how HRQL data are presented in RCTs was evident.Conclusions: Current practice of reporting HRQL outcomes in RCTs remains highly variable, both with regard to quality of reporting and the patterns of data analysis and presentation. This variation presents challenges for clinicians to apply these data in clinical practice. Consistent reporting practices, which are interpretable by clinicians, are required, as are processes to achieve this consistency in future reports. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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