Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists
Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, ga...
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| description | Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem.
We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden.
Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection. |
| doi_str_mv | 10.1371/journal.pone.0076625 |
| format | Article |
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We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden.
Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0076625</identifier><identifier>PMID: 24124580</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Bias ; Cancer ; Clinical trials ; Clinical Trials as Topic - standards ; Content analysis ; Data Collection ; Education ; Ethics ; Health care ; Health care policy ; Humans ; Interviews ; Medical personnel ; Medical research ; Methods ; Nurses ; Nursing research ; Patients ; Primary care ; Qualitative analysis ; Qualitative Research ; Quality of Life ; Research Design ; Research Personnel ; Researchers ; Studies ; Surveys and Questionnaires ; Training ; Well being</subject><ispartof>PloS one, 2013-10, Vol.8 (10), p.e76625-e76625</ispartof><rights>COPYRIGHT 2013 Public Library of Science</rights><rights>2013 Kyte et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2013 Kyte et al 2013 Kyte et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-e56fc6522aa96fcda65fa20ae4e79a202f30499ea97348f5a92048f2f3779f533</citedby><cites>FETCH-LOGICAL-c692t-e56fc6522aa96fcda65fa20ae4e79a202f30499ea97348f5a92048f2f3779f533</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3790726/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3790726/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2095,2914,23846,27903,27904,53770,53772,79347,79348</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24124580$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Lam, Wendy Wing Tak</contributor><creatorcontrib>Kyte, Derek</creatorcontrib><creatorcontrib>Ives, Jonathan</creatorcontrib><creatorcontrib>Draper, Heather</creatorcontrib><creatorcontrib>Keeley, Thomas</creatorcontrib><creatorcontrib>Calvert, Melanie</creatorcontrib><title>Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem.
We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden.
Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kyte, Derek</au><au>Ives, Jonathan</au><au>Draper, Heather</au><au>Keeley, Thomas</au><au>Calvert, Melanie</au><au>Lam, Wendy Wing Tak</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2013-10-04</date><risdate>2013</risdate><volume>8</volume><issue>10</issue><spage>e76625</spage><epage>e76625</epage><pages>e76625-e76625</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem.
We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden.
Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>24124580</pmid><doi>10.1371/journal.pone.0076625</doi><tpages>e76625</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Bias Cancer Clinical trials Clinical Trials as Topic - standards Content analysis Data Collection Education Ethics Health care Health care policy Humans Interviews Medical personnel Medical research Methods Nurses Nursing research Patients Primary care Qualitative analysis Qualitative Research Quality of Life Research Design Research Personnel Researchers Studies Surveys and Questionnaires Training Well being |
| title | Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists |
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