Identifying research priorities for effective retention strategies in clinical trials

A. Kearney; A. Daykin; A.R.G. Shaw; A.J. Lane; J.M. Blazeby; M. Clarke; P. Williamson; C. Gamble

doi:10.1186/s13063-017-2132-z

Identifying research priorities for effective retention strategies in clinical trials

A. Kearney, A. Daykin, A.R.G. Shaw, A.J. Lane, J.M. Blazeby, M. Clarke, P. Williamson, C. Gamble

Research output: Contribution to journal › Article (Academic Journal) › peer-review

30 Citations (Scopus)

349 Downloads (Pure)

Abstract

Background: The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and potentially introduces bias into the analysis. Identifying strategies to minimise missing data was the second highest methodological research priority in a Delphi survey of the Directors of UK Clinical Trial Units (CTUs) and is important to minimise waste in research. Our aim was to assess the current retention practices within the UK and priorities for future research to evaluate the effectiveness of strategies to reduce attrition. Methods: Seventy-five chief investigators of NIHR Health Technology Assessment (HTA)-funded trials starting between 2009 and 2012 were surveyed to elicit their awareness about causes of missing data within their trial and recommended practices for improving retention. Forty-seven CTUs registered within the UKCRC network were surveyed separately to identify approaches and strategies being used to mitigate missing data across trials. Responses from the current practice surveys were used to inform a subsequent two-round Delphi survey with registered CTUs. A consensus list of retention research strategies was produced and ranked by priority. Results: Fifty out of seventy-five (67%) chief investigators and 33/47 (70%) registered CTUs completed the current practice surveys. Seventy-eight percent of trialists were aware of retention challenges and implemented strategies at trial design. Patient-initiated withdrawal was the most common cause of missing data. Registered CTUs routinely used newsletters, timeline of participant visits, and telephone reminders to mitigate missing data. Whilst 36 out of 59 strategies presented had been formally or informally evaluated, some frequently used strategies, such as site initiation training, have had no research to inform practice. Thirty-five registered CTUs (74%) participated in the Delphi survey. Research into the effectiveness of site initiation training, frequency of patient contact during a trial, the use of routinely collected data, the frequency and timing of reminders, triggered site training and the time needed to complete questionnaires was deemed critical. Research into the effectiveness of Christmas cards for site staff was not of critical importance. Conclusion: The surveys of current practices demonstrates that a variety of strategies are being used to mitigate missing data but with little evidence to support their use. Six retention strategies were deemed critically important within the Delphi survey and should be a primary focus of future retention research. © 2017 The Author(s).

Original language	English
Journal	Trials
Volume	18
Issue number	1
DOIs	https://doi.org/10.1186/s13063-017-2132-z
Publication status	Published - 31 Aug 2017

Bibliographical note

Export Date: 13 September 2017

Correspondence Address: Kearney, A.; University of Liverpool, Institute of Child Health, Alder Hey NHS Trust, North West Hub for Trials Methodology Research/Clinical Trial Research Centre, BiostatisticsUnited Kingdom; email: A.kearney@liv.ac.uk

References: Toerien, M., Brookes, S.T., Metcalfe, C., Salis, I., Tomlin, Z., Peters, T.J., A review of reporting of participant recruitment and retention in RCTs in six major journals (2009) Trials, 10, p. 52; Marcellus, L., Are we missing anything? Pursuing research on attrition (2004) CJNR (Can J Nurs Res), 36 (3), pp. 82-98; Flick, S.N., Managing attrition in clinical research (1988) Clin Psychol Rev, 8 (5), pp. 499-515; Gul, R.B., Ali, P.A., Clinical trials: the challenge of recruitment and retention of participants (2010) J Clin Nurs, 19 (1-2), pp. 227-233; Tudur Smith, C., Hickey, H., Clarke, M., Blazeby, J., Williamson, P., The trials methodological research agenda: results from a priority setting exercise (2014) Trials, 15 (1), p. 32; Salman, R.-S., Beller, E., Kagan, J., Hemminki, E., Phillips, R.S., Savulescu, J., Increasing value and reducing waste in biomedical research regulation and management (2014) Lancet, 383 (9912), pp. 176-185; Chalmers, I., Bracken, M.B., Djulbegovic, B., Garattini, S., Grant, J., Gülmezoglu, A.M., How to increase value and reduce waste when research priorities are set (2014) Lancet, 383 (9912), pp. 156-165; Ioannidis, J.P.A., Greenland, S., Hlatky, M.A., Khoury, M.J., Macleod, M.R., Moher, D., Increasing value and reducing waste in research design, conduct, and analysis (2014) Lancet, 383 (9912), pp. 166-175; Chan, A.-W., Song, F., Vickers, A., Jefferson, T., Dickersin, K., Gøtzsche, P.C., Increasing value and reducing waste: addressing inaccessible research (2014) Lancet, 383 (9913), pp. 257-266; Glasziou, P., Altman, D.G., Bossuyt, P., Boutron, I., Clarke, M., Julious, S., Reducing waste from incomplete or unusable reports of biomedical research (2014) Lancet, 383 (9913), pp. 267-276; Wartella, E.A., (2010) Prevention and treatment of missing data in clinical trials, , Washington, DC: National Academies Press; Agency, E.M., (2010) Guideline on missing data in confirmatory clinical trials 2011, , http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf, Accessed 1 Mar 2017; O'Neill, R.T., Temple, R., The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it (2012) Clin Pharmacol Ther, 91 (3), pp. 550-554; Little, R.J., Cohen, M.L., Dickersin, K., Emerson, S.S., Farrar, J.T., Neaton, J.D., The design and conduct of clinical trials to limit missing data (2012) Stat Med, 31 (28), pp. 3433-3443; (2014) Health Technology Assessment Programme Portfolio, , https://www.nihr.ac.uk/funding-and-support/funding-for-research-studies/funding-programmes/health-technology-assessment/, Accessed 23 Sept; Bower, P., Brueton, V., Gamble, C., Treweek, S., Smith, C.T., Young, B., Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities (2014) Trials, 15, p. 9; Brueton, V.C., Tierney, J., Stenning, S., Harding, S., Meredith, S., Nazareth, I., Strategies to improve retention in randomised trials (2013) Cochrane Database Syst Rev, 12. , MR000032; Guyatt, G.H., Oxman, A.D., Kunz, R., Atkins, D., Brozek, J., Vist, G., GRADE guidelines: 2. Framing the question and deciding on important outcomes (2011) J Clin Epidemiol, 64 (4), pp. 395-400; Harman, N., Bruce, I., Callery, P., Tierney, S., Sharif, M.O., O'Brien, K., MOMENT- Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey (2013) Trials, 14 (1), p. 70; (2017) Performance in initiating and delivering clinical research, , https://www.nihr.ac.uk/research-and-impact/documents/PID%20Documents/Guidance%20Documents/Performance%20in%20Initiating%20and%20Delivering%20Guidelines%20Published.pdf, Accessed 23 June 2017; (2017) SWAT/SWAR information (Studies Within A Trial/Studies Within A Review), , https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/, Accessed 12 Feb; Bower, P., (2017) Systematic techniques for assisting recruitment to trials (MRC START), , http://research.bmh.manchester.ac.uk/mrcstart, Accessed 23 June; Nicholson, L.M., Schwirian, P.M., Klein, E.G., Skybo, T., Murray-Johnson, L., Eneli, I., Recruitment and retention strategies in longitudinal clinical studies with low-income populations (2011) Contemp Clin Trials, 32 (3), pp. 353-362; Jenkins, V., Fallowfield, L., Solis-Trapala, I., Langridge, C., Farewell, V., Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme (2005) BMJ, 330 (7488), p. 400; Jenkins, V.A., Farewell, D., Farewell, V., Batt, L., Wagstaff, J., Langridge, C., Teams talking trials: results of an RCT to improve the communication of cancer teams about treatment trials (2013) Contemp Clin Trials, 35 (1), pp. 43-51; Townsend, D., Mills, N., Savovic, J., Donovan, J.L., A systematic review of training programmes for recruiters to randomised controlled trials (2015) Trials, 16, p. 432; Fallowfield, L., Langridge, C., Jenkins, V., Communication skills training for breast cancer teams talking about trials (2014) Breast, 23 (2), pp. 193-197; Bhatnagar, S., Hoberman, A., Kearney, D.H., Shaikh, N., Moxey-Mims, M.M., Chesney, R.W., Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial (2014) Clin Pediatr, 53 (2), pp. 151-157; Lienard, J.L., Quinaux, E., Fabre-Guillevin, E., Piedbois, P., Jouhaud, A., Decoster, G., Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer (2006) Clinical trials, 3 (5), pp. 486-492. , http://ctj.sagepub.com/content/3/5/486.full.pdf, Accessed 22 Aug 2017; Berger, A.M., Neumark, D.E., Chamberlain, J., Enhancing recruitment and retention in randomized clinical trials of cancer symptom management (2007) Oncol Nurs Forum, 34 (2), pp. E17-22; Dillman, D.A., (1978) Mail and telephone surveys: The total design method, , Wiley New York

Structured keywords

BTC (Bristol Trials Centre)
Centre for Surgical Research

Keywords

Attrition
Clinical trials
Missing data
Missing data strategies
Retention
Study design

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10.1186/s13063-017-2132-z

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Blazeby, J.
1/04/14 → 31/03/19
Project: Research

Cite this

@article{5ce83de98b674d1ab253fd3b1f2964aa,

title = "Identifying research priorities for effective retention strategies in clinical trials",

abstract = "Background: The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and potentially introduces bias into the analysis. Identifying strategies to minimise missing data was the second highest methodological research priority in a Delphi survey of the Directors of UK Clinical Trial Units (CTUs) and is important to minimise waste in research. Our aim was to assess the current retention practices within the UK and priorities for future research to evaluate the effectiveness of strategies to reduce attrition. Methods: Seventy-five chief investigators of NIHR Health Technology Assessment (HTA)-funded trials starting between 2009 and 2012 were surveyed to elicit their awareness about causes of missing data within their trial and recommended practices for improving retention. Forty-seven CTUs registered within the UKCRC network were surveyed separately to identify approaches and strategies being used to mitigate missing data across trials. Responses from the current practice surveys were used to inform a subsequent two-round Delphi survey with registered CTUs. A consensus list of retention research strategies was produced and ranked by priority. Results: Fifty out of seventy-five (67%) chief investigators and 33/47 (70%) registered CTUs completed the current practice surveys. Seventy-eight percent of trialists were aware of retention challenges and implemented strategies at trial design. Patient-initiated withdrawal was the most common cause of missing data. Registered CTUs routinely used newsletters, timeline of participant visits, and telephone reminders to mitigate missing data. Whilst 36 out of 59 strategies presented had been formally or informally evaluated, some frequently used strategies, such as site initiation training, have had no research to inform practice. Thirty-five registered CTUs (74%) participated in the Delphi survey. Research into the effectiveness of site initiation training, frequency of patient contact during a trial, the use of routinely collected data, the frequency and timing of reminders, triggered site training and the time needed to complete questionnaires was deemed critical. Research into the effectiveness of Christmas cards for site staff was not of critical importance. Conclusion: The surveys of current practices demonstrates that a variety of strategies are being used to mitigate missing data but with little evidence to support their use. Six retention strategies were deemed critically important within the Delphi survey and should be a primary focus of future retention research. {\textcopyright} 2017 The Author(s).",

keywords = "Attrition, Clinical trials, Missing data, Missing data strategies, Retention, Study design",

author = "A. Kearney and A. Daykin and A.R.G. Shaw and A.J. Lane and J.M. Blazeby and M. Clarke and P. Williamson and C. Gamble",

note = "Export Date: 13 September 2017 Correspondence Address: Kearney, A.; University of Liverpool, Institute of Child Health, Alder Hey NHS Trust, North West Hub for Trials Methodology Research/Clinical Trial Research Centre, BiostatisticsUnited Kingdom; email: A.kearney@liv.ac.uk References: Toerien, M., Brookes, S.T., Metcalfe, C., Salis, I., Tomlin, Z., Peters, T.J., A review of reporting of participant recruitment and retention in RCTs in six major journals (2009) Trials, 10, p. 52; Marcellus, L., Are we missing anything? Pursuing research on attrition (2004) CJNR (Can J Nurs Res), 36 (3), pp. 82-98; Flick, S.N., Managing attrition in clinical research (1988) Clin Psychol Rev, 8 (5), pp. 499-515; Gul, R.B., Ali, P.A., Clinical trials: the challenge of recruitment and retention of participants (2010) J Clin Nurs, 19 (1-2), pp. 227-233; Tudur Smith, C., Hickey, H., Clarke, M., Blazeby, J., Williamson, P., The trials methodological research agenda: results from a priority setting exercise (2014) Trials, 15 (1), p. 32; Salman, R.-S., Beller, E., Kagan, J., Hemminki, E., Phillips, R.S., Savulescu, J., Increasing value and reducing waste in biomedical research regulation and management (2014) Lancet, 383 (9912), pp. 176-185; Chalmers, I., Bracken, M.B., Djulbegovic, B., Garattini, S., Grant, J., G{\"u}lmezoglu, A.M., How to increase value and reduce waste when research priorities are set (2014) Lancet, 383 (9912), pp. 156-165; Ioannidis, J.P.A., Greenland, S., Hlatky, M.A., Khoury, M.J., Macleod, M.R., Moher, D., Increasing value and reducing waste in research design, conduct, and analysis (2014) Lancet, 383 (9912), pp. 166-175; Chan, A.-W., Song, F., Vickers, A., Jefferson, T., Dickersin, K., G{\o}tzsche, P.C., Increasing value and reducing waste: addressing inaccessible research (2014) Lancet, 383 (9913), pp. 257-266; Glasziou, P., Altman, D.G., Bossuyt, P., Boutron, I., Clarke, M., Julious, S., Reducing waste from incomplete or unusable reports of biomedical research (2014) Lancet, 383 (9913), pp. 267-276; Wartella, E.A., (2010) Prevention and treatment of missing data in clinical trials, , Washington, DC: National Academies Press; Agency, E.M., (2010) Guideline on missing data in confirmatory clinical trials 2011, , http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf, Accessed 1 Mar 2017; O'Neill, R.T., Temple, R., The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it (2012) Clin Pharmacol Ther, 91 (3), pp. 550-554; Little, R.J., Cohen, M.L., Dickersin, K., Emerson, S.S., Farrar, J.T., Neaton, J.D., The design and conduct of clinical trials to limit missing data (2012) Stat Med, 31 (28), pp. 3433-3443; (2014) Health Technology Assessment Programme Portfolio, , https://www.nihr.ac.uk/funding-and-support/funding-for-research-studies/funding-programmes/health-technology-assessment/, Accessed 23 Sept; Bower, P., Brueton, V., Gamble, C., Treweek, S., Smith, C.T., Young, B., Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities (2014) Trials, 15, p. 9; Brueton, V.C., Tierney, J., Stenning, S., Harding, S., Meredith, S., Nazareth, I., Strategies to improve retention in randomised trials (2013) Cochrane Database Syst Rev, 12. , MR000032; Guyatt, G.H., Oxman, A.D., Kunz, R., Atkins, D., Brozek, J., Vist, G., GRADE guidelines: 2. Framing the question and deciding on important outcomes (2011) J Clin Epidemiol, 64 (4), pp. 395-400; Harman, N., Bruce, I., Callery, P., Tierney, S., Sharif, M.O., O'Brien, K., MOMENT- Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey (2013) Trials, 14 (1), p. 70; (2017) Performance in initiating and delivering clinical research, , https://www.nihr.ac.uk/research-and-impact/documents/PID%20Documents/Guidance%20Documents/Performance%20in%20Initiating%20and%20Delivering%20Guidelines%20Published.pdf, Accessed 23 June 2017; (2017) SWAT/SWAR information (Studies Within A Trial/Studies Within A Review), , https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/, Accessed 12 Feb; Bower, P., (2017) Systematic techniques for assisting recruitment to trials (MRC START), , http://research.bmh.manchester.ac.uk/mrcstart, Accessed 23 June; Nicholson, L.M., Schwirian, P.M., Klein, E.G., Skybo, T., Murray-Johnson, L., Eneli, I., Recruitment and retention strategies in longitudinal clinical studies with low-income populations (2011) Contemp Clin Trials, 32 (3), pp. 353-362; Jenkins, V., Fallowfield, L., Solis-Trapala, I., Langridge, C., Farewell, V., Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme (2005) BMJ, 330 (7488), p. 400; Jenkins, V.A., Farewell, D., Farewell, V., Batt, L., Wagstaff, J., Langridge, C., Teams talking trials: results of an RCT to improve the communication of cancer teams about treatment trials (2013) Contemp Clin Trials, 35 (1), pp. 43-51; Townsend, D., Mills, N., Savovic, J., Donovan, J.L., A systematic review of training programmes for recruiters to randomised controlled trials (2015) Trials, 16, p. 432; Fallowfield, L., Langridge, C., Jenkins, V., Communication skills training for breast cancer teams talking about trials (2014) Breast, 23 (2), pp. 193-197; Bhatnagar, S., Hoberman, A., Kearney, D.H., Shaikh, N., Moxey-Mims, M.M., Chesney, R.W., Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial (2014) Clin Pediatr, 53 (2), pp. 151-157; Lienard, J.L., Quinaux, E., Fabre-Guillevin, E., Piedbois, P., Jouhaud, A., Decoster, G., Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer (2006) Clinical trials, 3 (5), pp. 486-492. , http://ctj.sagepub.com/content/3/5/486.full.pdf, Accessed 22 Aug 2017; Berger, A.M., Neumark, D.E., Chamberlain, J., Enhancing recruitment and retention in randomized clinical trials of cancer symptom management (2007) Oncol Nurs Forum, 34 (2), pp. E17-22; Dillman, D.A., (1978) Mail and telephone surveys: The total design method, , Wiley New York",

year = "2017",

month = aug,

day = "31",

doi = "10.1186/s13063-017-2132-z",

language = "English",

volume = "18",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

}

TY - JOUR

T1 - Identifying research priorities for effective retention strategies in clinical trials

AU - Kearney, A.

AU - Daykin, A.

AU - Shaw, A.R.G.

AU - Lane, A.J.

AU - Blazeby, J.M.

AU - Clarke, M.

AU - Williamson, P.

AU - Gamble, C.

N1 - Export Date: 13 September 2017 Correspondence Address: Kearney, A.; University of Liverpool, Institute of Child Health, Alder Hey NHS Trust, North West Hub for Trials Methodology Research/Clinical Trial Research Centre, BiostatisticsUnited Kingdom; email: A.kearney@liv.ac.uk References: Toerien, M., Brookes, S.T., Metcalfe, C., Salis, I., Tomlin, Z., Peters, T.J., A review of reporting of participant recruitment and retention in RCTs in six major journals (2009) Trials, 10, p. 52; Marcellus, L., Are we missing anything? Pursuing research on attrition (2004) CJNR (Can J Nurs Res), 36 (3), pp. 82-98; Flick, S.N., Managing attrition in clinical research (1988) Clin Psychol Rev, 8 (5), pp. 499-515; Gul, R.B., Ali, P.A., Clinical trials: the challenge of recruitment and retention of participants (2010) J Clin Nurs, 19 (1-2), pp. 227-233; Tudur Smith, C., Hickey, H., Clarke, M., Blazeby, J., Williamson, P., The trials methodological research agenda: results from a priority setting exercise (2014) Trials, 15 (1), p. 32; Salman, R.-S., Beller, E., Kagan, J., Hemminki, E., Phillips, R.S., Savulescu, J., Increasing value and reducing waste in biomedical research regulation and management (2014) Lancet, 383 (9912), pp. 176-185; Chalmers, I., Bracken, M.B., Djulbegovic, B., Garattini, S., Grant, J., Gülmezoglu, A.M., How to increase value and reduce waste when research priorities are set (2014) Lancet, 383 (9912), pp. 156-165; Ioannidis, J.P.A., Greenland, S., Hlatky, M.A., Khoury, M.J., Macleod, M.R., Moher, D., Increasing value and reducing waste in research design, conduct, and analysis (2014) Lancet, 383 (9912), pp. 166-175; Chan, A.-W., Song, F., Vickers, A., Jefferson, T., Dickersin, K., Gøtzsche, P.C., Increasing value and reducing waste: addressing inaccessible research (2014) Lancet, 383 (9913), pp. 257-266; Glasziou, P., Altman, D.G., Bossuyt, P., Boutron, I., Clarke, M., Julious, S., Reducing waste from incomplete or unusable reports of biomedical research (2014) Lancet, 383 (9913), pp. 267-276; Wartella, E.A., (2010) Prevention and treatment of missing data in clinical trials, , Washington, DC: National Academies Press; Agency, E.M., (2010) Guideline on missing data in confirmatory clinical trials 2011, , http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf, Accessed 1 Mar 2017; O'Neill, R.T., Temple, R., The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it (2012) Clin Pharmacol Ther, 91 (3), pp. 550-554; Little, R.J., Cohen, M.L., Dickersin, K., Emerson, S.S., Farrar, J.T., Neaton, J.D., The design and conduct of clinical trials to limit missing data (2012) Stat Med, 31 (28), pp. 3433-3443; (2014) Health Technology Assessment Programme Portfolio, , https://www.nihr.ac.uk/funding-and-support/funding-for-research-studies/funding-programmes/health-technology-assessment/, Accessed 23 Sept; Bower, P., Brueton, V., Gamble, C., Treweek, S., Smith, C.T., Young, B., Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities (2014) Trials, 15, p. 9; Brueton, V.C., Tierney, J., Stenning, S., Harding, S., Meredith, S., Nazareth, I., Strategies to improve retention in randomised trials (2013) Cochrane Database Syst Rev, 12. , MR000032; Guyatt, G.H., Oxman, A.D., Kunz, R., Atkins, D., Brozek, J., Vist, G., GRADE guidelines: 2. Framing the question and deciding on important outcomes (2011) J Clin Epidemiol, 64 (4), pp. 395-400; Harman, N., Bruce, I., Callery, P., Tierney, S., Sharif, M.O., O'Brien, K., MOMENT- Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey (2013) Trials, 14 (1), p. 70; (2017) Performance in initiating and delivering clinical research, , https://www.nihr.ac.uk/research-and-impact/documents/PID%20Documents/Guidance%20Documents/Performance%20in%20Initiating%20and%20Delivering%20Guidelines%20Published.pdf, Accessed 23 June 2017; (2017) SWAT/SWAR information (Studies Within A Trial/Studies Within A Review), , https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/, Accessed 12 Feb; Bower, P., (2017) Systematic techniques for assisting recruitment to trials (MRC START), , http://research.bmh.manchester.ac.uk/mrcstart, Accessed 23 June; Nicholson, L.M., Schwirian, P.M., Klein, E.G., Skybo, T., Murray-Johnson, L., Eneli, I., Recruitment and retention strategies in longitudinal clinical studies with low-income populations (2011) Contemp Clin Trials, 32 (3), pp. 353-362; Jenkins, V., Fallowfield, L., Solis-Trapala, I., Langridge, C., Farewell, V., Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme (2005) BMJ, 330 (7488), p. 400; Jenkins, V.A., Farewell, D., Farewell, V., Batt, L., Wagstaff, J., Langridge, C., Teams talking trials: results of an RCT to improve the communication of cancer teams about treatment trials (2013) Contemp Clin Trials, 35 (1), pp. 43-51; Townsend, D., Mills, N., Savovic, J., Donovan, J.L., A systematic review of training programmes for recruiters to randomised controlled trials (2015) Trials, 16, p. 432; Fallowfield, L., Langridge, C., Jenkins, V., Communication skills training for breast cancer teams talking about trials (2014) Breast, 23 (2), pp. 193-197; Bhatnagar, S., Hoberman, A., Kearney, D.H., Shaikh, N., Moxey-Mims, M.M., Chesney, R.W., Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial (2014) Clin Pediatr, 53 (2), pp. 151-157; Lienard, J.L., Quinaux, E., Fabre-Guillevin, E., Piedbois, P., Jouhaud, A., Decoster, G., Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer (2006) Clinical trials, 3 (5), pp. 486-492. , http://ctj.sagepub.com/content/3/5/486.full.pdf, Accessed 22 Aug 2017; Berger, A.M., Neumark, D.E., Chamberlain, J., Enhancing recruitment and retention in randomized clinical trials of cancer symptom management (2007) Oncol Nurs Forum, 34 (2), pp. E17-22; Dillman, D.A., (1978) Mail and telephone surveys: The total design method, , Wiley New York

PY - 2017/8/31

Y1 - 2017/8/31

N2 - Background: The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and potentially introduces bias into the analysis. Identifying strategies to minimise missing data was the second highest methodological research priority in a Delphi survey of the Directors of UK Clinical Trial Units (CTUs) and is important to minimise waste in research. Our aim was to assess the current retention practices within the UK and priorities for future research to evaluate the effectiveness of strategies to reduce attrition. Methods: Seventy-five chief investigators of NIHR Health Technology Assessment (HTA)-funded trials starting between 2009 and 2012 were surveyed to elicit their awareness about causes of missing data within their trial and recommended practices for improving retention. Forty-seven CTUs registered within the UKCRC network were surveyed separately to identify approaches and strategies being used to mitigate missing data across trials. Responses from the current practice surveys were used to inform a subsequent two-round Delphi survey with registered CTUs. A consensus list of retention research strategies was produced and ranked by priority. Results: Fifty out of seventy-five (67%) chief investigators and 33/47 (70%) registered CTUs completed the current practice surveys. Seventy-eight percent of trialists were aware of retention challenges and implemented strategies at trial design. Patient-initiated withdrawal was the most common cause of missing data. Registered CTUs routinely used newsletters, timeline of participant visits, and telephone reminders to mitigate missing data. Whilst 36 out of 59 strategies presented had been formally or informally evaluated, some frequently used strategies, such as site initiation training, have had no research to inform practice. Thirty-five registered CTUs (74%) participated in the Delphi survey. Research into the effectiveness of site initiation training, frequency of patient contact during a trial, the use of routinely collected data, the frequency and timing of reminders, triggered site training and the time needed to complete questionnaires was deemed critical. Research into the effectiveness of Christmas cards for site staff was not of critical importance. Conclusion: The surveys of current practices demonstrates that a variety of strategies are being used to mitigate missing data but with little evidence to support their use. Six retention strategies were deemed critically important within the Delphi survey and should be a primary focus of future retention research. © 2017 The Author(s).

AB - Background: The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and potentially introduces bias into the analysis. Identifying strategies to minimise missing data was the second highest methodological research priority in a Delphi survey of the Directors of UK Clinical Trial Units (CTUs) and is important to minimise waste in research. Our aim was to assess the current retention practices within the UK and priorities for future research to evaluate the effectiveness of strategies to reduce attrition. Methods: Seventy-five chief investigators of NIHR Health Technology Assessment (HTA)-funded trials starting between 2009 and 2012 were surveyed to elicit their awareness about causes of missing data within their trial and recommended practices for improving retention. Forty-seven CTUs registered within the UKCRC network were surveyed separately to identify approaches and strategies being used to mitigate missing data across trials. Responses from the current practice surveys were used to inform a subsequent two-round Delphi survey with registered CTUs. A consensus list of retention research strategies was produced and ranked by priority. Results: Fifty out of seventy-five (67%) chief investigators and 33/47 (70%) registered CTUs completed the current practice surveys. Seventy-eight percent of trialists were aware of retention challenges and implemented strategies at trial design. Patient-initiated withdrawal was the most common cause of missing data. Registered CTUs routinely used newsletters, timeline of participant visits, and telephone reminders to mitigate missing data. Whilst 36 out of 59 strategies presented had been formally or informally evaluated, some frequently used strategies, such as site initiation training, have had no research to inform practice. Thirty-five registered CTUs (74%) participated in the Delphi survey. Research into the effectiveness of site initiation training, frequency of patient contact during a trial, the use of routinely collected data, the frequency and timing of reminders, triggered site training and the time needed to complete questionnaires was deemed critical. Research into the effectiveness of Christmas cards for site staff was not of critical importance. Conclusion: The surveys of current practices demonstrates that a variety of strategies are being used to mitigate missing data but with little evidence to support their use. Six retention strategies were deemed critically important within the Delphi survey and should be a primary focus of future retention research. © 2017 The Author(s).

KW - Attrition

KW - Clinical trials

KW - Missing data

KW - Missing data strategies

KW - Retention

KW - Study design

U2 - 10.1186/s13063-017-2132-z

DO - 10.1186/s13063-017-2132-z

M3 - Article (Academic Journal)

C2 - 28859674

VL - 18

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -

Identifying research priorities for effective retention strategies in clinical trials

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