Acceptability of a German multicentre healthcare research study: a survey of research personnels' attitudes, experiences and work load

Sebastian Blecha, Susanne Brandstetter, Frank Dodoo-Schittko, Magdalena Brandl, Bernhard M Graf, Thomas Bein, Christian Apfelbacher, Sebastian Blecha, Susanne Brandstetter, Frank Dodoo-Schittko, Magdalena Brandl, Bernhard M Graf, Thomas Bein, Christian Apfelbacher

Abstract

Objectives: The DACAPO study as a multicentre nationwide observational healthcare research study investigates the influence of quality of care on the quality of life in patients with acute respiratory distress syndrome. The aim of this study was to investigate the acceptability to the participating research personnels by assessing attitudes, experiences and workload associated with the conduct of the DACAPO study.

Design, setting and participants: A prospective anonymous online survey was sent via email account to 169 participants in 65 study centres. The questionnaire included six different domains: (1) training for performing the study; (2) obtaining informed consent; (3) data collection; (4) data entry using the online documentation system; (5) opinion towards the study and (6) personal data. Descriptive data analysis was carried out.

Results: A total of 78 participants took part (46%) in the survey, 75 questionnaires (44%) could be evaluated. 51% were senior medical specialists. 95% considered the time frame of the training as appropriate and the presentation was rated by 93% as good or very good. Time effort for obtaining consent, data collection and entry was considered by 41% as a burden. Support from the coordinating study centre was rated as good or very good by more than 90% of respondents. While the DACAPO study was seen as scientifically relevant by 81%, only 45% considered the study results valuable for improving patient care significantly.

Conclusion: Collecting feedback on the acceptability of a large multicentre healthcare research study provided important insights. Recruitment and data acquisition was mainly performed by physicians and often regarded as additional time burden in clinical practice. Reducing the amount of data collection and simplifying data entry could facilitate the conduct of healthcare research studies and could improve motivation of researchers in intensive care medicine.

Trial registration number: NCT02637011; Pre-results.

Keywords: health care research; online survey; quality management; study acceptability.

Conflict of interest statement

Competing interests: TB is the member of the Medical Advisory Board of Nova-Lung GmbH, Heilbronn, Germany and received honoraria in this function. He also received honoraria for lectures from Nova-Lung, Heilbronn, Germany during past 3 years. SeB, SuB, FD-S, MB, BG and CA declare no competing interest in relation to this paper.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Distribution of weekly survey participation (n=78).

References

    1. Sakr Y, Moreira CL, Rhodes A, et al. . The impact of hospital and ICU organizational factors on outcome in critically ill patients: results from the Extended Prevalence of Infection in Intensive Care study. Crit Care Med 2015;43:519–26. 10.1097/CCM.0000000000000754
    1. Turnbull AE, Rabiee A, Davis WE, et al. . Outcome measurement in ICU survivorship research from 1970 to 2013: a scoping review of 425 publications. Crit Care Med 2016;44:1267–77. 10.1097/CCM.0000000000001651
    1. Brandstetter S, Dodoo-Schittko F, Blecha S, et al. . Influence of quality of care and individual patient characteristics on quality of life and return to work in survivors of the acute respiratory distress syndrome: protocol for a prospective, observational, multi-centre patient cohort study (DACAPO). BMC Health Serv Res 2015;15:563 10.1186/s12913-015-1232-2
    1. Weled BJ, Adzhigirey LA, Hodgman TM, et al. . Critical care delivery: the importance of process of care and icu structure to improved outcomes: an update from the American college of critical care medicine task force on models of critical care. Crit Care Med 2015;43:1520–5. 10.1097/CCM.0000000000000978
    1. Cullati S, Courvoisier DS, Gayet-Ageron A, et al. . Patient enrollment and logistical problems top the list of difficulties in clinical research: a cross-sectional survey. BMC Med Res Methodol 2016;16:50 10.1186/s12874-016-0151-1
    1. Fletcher B, Gheorghe A, Moore D, et al. . Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open 2012;2:e000496 10.1136/bmjopen-2011-000496
    1. Treweek S, Lockhart P, Pitkethly M, et al. . Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open 2013;3:e002360 10.1136/bmjopen-2012-002360
    1. Luz AG, Osis MJ, Ribeiro M, et al. . Perspectives of professionals participating in the Brazilian Network for the Surveillance of Severe Maternal Morbidity regarding the implementation of routine surveillance: a qualitative study. Reprod Health 2014;11:29 10.1186/1742-4755-11-29
    1. Rosa-Rizzotto M, Visonà Dalla Pozza L, Turconi AC, et al. . The perception of involved professionals towards research feasibility and usefulness: lessons from the multi-site trial on efficacy of constraint induced movement therapy in children with Hemiplegia. Eur J Phys Rehabil Med 2010;46:369–76.
    1. Kunz R, Vist G, Oxman AD. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 2007;2:MR000012 10.1002/14651858.MR000012.pub2
    1. Ecarnot F, Quenot JP, Besch G, et al. . Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit. Ann Transl Med 2017;5(Suppl 4):S41
    1. Burns KE, Zubrinich C, Tan W, et al. . Research recruitment practices and critically ill patients. A multicenter, cross-sectional study (the Consent Study). Am J Respir Crit Care Med 2013;187:1212–8. 10.1164/rccm.201208-1537OC
    1. Rowlands C, Rooshenas L, Fairhurst K, et al. . Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital. BMJ Open 2018;8:e018581 10.1136/bmjopen-2017-018581
    1. Smith OM, McDonald E, Zytaruk N, et al. . Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial. J Crit Care 2013;28:28–39. 10.1016/j.jcrc.2012.08.005
    1. Larkey LK, Staten LK, Ritenbaugh C, et al. . Recruitment of hispanic women to the women’s health initiative. Control Clin Trials 2002;23:289–98. 10.1016/S0197-2456(02)00190-3
    1. Nahm M, Shepherd J, Buzenberg A, et al. . Design and implementation of an institutional case report form library. Clin Trials 2011;8:94–102. 10.1177/1740774510391916
    1. Bellary S, Krishnankutty B, Latha MS. Basics of case report form designing in clinical research. Perspect Clin Res 2014;5:159–66. 10.4103/2229-3485.140555
    1. Haak D, Samsel C, Gehlen J, et al. . Simplifying electronic data capture in clinical trials: workflow embedded image and biosignal file integration and analysis via web services. J Digit Imaging 2014;27:571–80. 10.1007/s10278-014-9694-z
    1. Shah J, Rajgor D, Pradhan S, et al. . Electronic data capture for registries and clinical trials in orthopaedic surgery: open source versus commercial systems. Clin Orthop Relat Res 2010;468:2664–71. 10.1007/s11999-010-1469-3
    1. Rorie DA, Flynn RWV, Grieve K, et al. . Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology. Br J Clin Pharmacol 2017;83:1880–95. 10.1111/bcp.13285
    1. Ware J, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34:220–33.
    1. Gosling SD, Vazire S, Srivastava S, et al. . Should we trust web-based studies? A comparative analysis of six preconceptions about internet questionnaires. Am Psychol 2004;59:93–104. 10.1037/0003-066X.59.2.93
    1. Cobanoglu C, Moreo PJ, Warde B. A comparison of mail, fax and web-based survey methods. International Journal of Market Research 2001;43:1–15. 10.1177/147078530104300401
    1. Dushianthan A, Cusack R, Chee N, et al. . Perceptions of diagnosis and management of patients with acute respiratory distress syndrome: a survey of United Kingdom intensive care physicians. BMC Anesthesiol 2014;14:87 10.1186/1471-2253-14-87
    1. Watson JM, Torgerson DJ. Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC Med Res Methodol 2006;6:34 10.1186/1471-2288-6-34
    1. Cook DJ, Blythe D, Rischbieth A, et al. . Enrollment of intensive care unit patients into clinical studies: a trinational survey of researchers' experiences, beliefs, and practices. Crit Care Med 2008;36:2100–5. 10.1097/CCM.0b013e31817c00b0
    1. Schweickert W, Hall J. Informed consent in the intensive care unit: ensuring understanding in a complex environment. Curr Opin Crit Care 2005;11:624–8. 10.1097/01.ccx.0000186378.41697.09
    1. Gillett GR. Intensive care unit research ethics and trials on unconscious patients. Anaesth Intensive Care 2015;43:309–12.
    1. Lindh JD, Kublickas M, Westgren M, et al. . Internet based clinical trial protocols -- as applied to a study of warfarin pharmacogenetics. Br J Clin Pharmacol 2004;58:482–7. 10.1111/j.1365-2125.2004.02206.x
    1. Das S, Zijdenbos AP, Harlap J, et al. . LORIS: a web-based data management system for multi-center studies. Front Neuroinform 2011;5:37 10.3389/fninf.2011.00037
    1. Arain M, Campbell MJ, Cooper CL, et al. . What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol 2010;10:67 10.1186/1471-2288-10-67
    1. El Emam K, Jonker E, Sampson M, et al. . The use of electronic data capture tools in clinical trials: Web-survey of 259 Canadian trials. J Med Internet Res 2009;11:e8 10.2196/jmir.1120
    1. Walther B, Hossin S, Townend J, et al. . Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data. PLoS One 2011;6:e25348 10.1371/journal.pone.0025348
    1. Franklin JD, Guidry A, Brinkley JF. A partnership approach for electronic data capture in small-scale clinical trials. J Biomed Inform 2011;44 Suppl 1(Suppl 1):S103–S108. 10.1016/j.jbi.2011.05.008
    1. Deserno TM, Deserno V, Haak D, et al. . Digital imaging and electronic data capture in multi-center clinical trials. Stud Health Technol Inform 2015;216:930.
    1. Pavlović I, Kern T, Miklavcic D. Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study. Contemp Clin Trials 2009;30:300–16. 10.1016/j.cct.2009.03.008
    1. Rendell JM, Merritt RD, Geddes JR. Incentives and disincentives to participation by clinicians in randomised controlled trials. Cochrane Database Syst Rev 2007;2:MR000021 10.1002/14651858.MR000021.pub3
    1. Raftery J, Kerr C, Hawker S, et al. . Paying clinicians to join clinical trials: a review of guidelines and interview study of trialists. Trials 2009;10:15 10.1186/1745-6215-10-15
    1. Ohmann C, Deimling A. Attitude towards clinical trials: results of a survey of persons interested in research. Inflamm Res 2004;53 Suppl 2(Suppl 2):S142–7. 10.1007/s00011-004-0353-6
    1. Costa DK, Kuza CC, Kahn JM. Differences between nurse- and physician-assessed ICU characteristics using a standardized survey. Int J Qual Health Care 2015;27:344–8. 10.1093/intqhc/mzv062
    1. Rycroft-Malone J, McCormack B, Hutchinson AM, et al. . Realist synthesis: illustrating the method for implementation research. Implement Sci 2012;7:33 10.1186/1748-5908-7-33
    1. Smith F, Lachish S, Goldacre MJ, et al. . Factors influencing the decisions of senior UK doctors to retire or remain in medicine: national surveys of the UK-trained medical graduates of 1974 and 1977. BMJ Open 2017;7:e017650 10.1136/bmjopen-2017-017650
    1. Avins AL, Goldberg H. Creating a culture of research. Contemp Clin Trials 2007;28:557–62. 10.1016/j.cct.2007.02.004

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