Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital

Objectives To examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature. Design Studies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study. Results Of 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more ‘real’ RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent. Conclusion There is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment.

[1]  R. Conwit,et al.  Recruitment and retention of patients into emergency medicine clinical trials. , 2010, Academic emergency medicine : official journal of the Society for Academic Emergency Medicine.

[2]  S. Johnston,et al.  Recruiting Subjects for Acute Stroke Trials: A Meta-Analysis , 2006, Stroke.

[3]  M Egger,et al.  Grey literature in meta-analyses of randomized trials of health care interventions. , 2007, The Cochrane database of systematic reviews.

[4]  B. Lewis,et al.  Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction. , 2000, Archives of internal medicine.

[5]  P. Safar,et al.  Deferred consent: use in clinical resuscitation research. Brain Resuscitation Clinical Trial II Study Group. , 1990, Annals of emergency medicine.

[6]  E. Fish,et al.  Using real-time alerts for clinical trials , 2011, Applied Clinical Informatics.

[7]  I Roberts,et al.  Strategies to improve recruitment to research studies. , 2002, The Cochrane database of systematic reviews.

[8]  D. Cook,et al.  Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial. , 2013, Journal of critical care.

[9]  P. Williamson,et al.  The trials methodological research agenda: results from a priority setting exercise , 2014, Trials.

[10]  M. Tracy,et al.  Strategies for overcoming site and recruitment challenges in research studies based in intensive care units. , 2009, American journal of critical care : an official publication, American Association of Critical-Care Nurses.

[11]  Marc Moss,et al.  Surrogate and patient discrepancy regarding consent for critical care research , 2012, Critical care medicine.

[12]  J. Karlawish,et al.  How important is surrogate consent for stroke research? , 2008, Neurology.

[13]  Ellen McDonald,et al.  Research recruitment practices and critically ill patients. A multicenter, cross-sectional study (the Consent Study). , 2013, American journal of respiratory and critical care medicine.

[14]  P. Aurup,et al.  Clinical Trial Educator program – a novel approach to accelerate enrollment in a phase III International Acute Coronary Syndrome Trial , 2012, Clinical trials.

[15]  D. Fayter,et al.  Increasing participation of cancer patients in randomised controlled trials: a systematic review , 2006, Trials.

[16]  S. Vedula,et al.  Cost-effectiveness of health research study participant recruitment strategies: A systematic review , 2014, Clinical trials.

[17]  Hester F. Lingsma,et al.  The influence of enrollment criteria on recruitment and outcome distribution in traumatic brain injury studies: results from the impact study. , 2009, Journal of neurotrauma.

[18]  P. Armstrong,et al.  Transition from meeting abstract to full-length journal article for randomized controlled trials. , 2006, JAMA.

[19]  A. Gheorghe,et al.  Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review , 2012, BMJ Open.

[20]  D. Choudhury,et al.  Lessons for successful study enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study. , 2008, Clinical journal of the American Society of Nephrology : CJASN.

[21]  D. Costescu,et al.  Lessons learned from a resident-led clinical trial in obstetrics , 2013, Clinical trials.

[22]  A. Algra,et al.  Informed consent in trials for neurological emergencies: the example of subarachnoid haemorrhage , 2003, Journal of neurology, neurosurgery, and psychiatry.

[23]  H. Adams,et al.  Extending Acute Trials to Remote Populations: A Pilot Study During Interhospital Helicopter Transfer , 2009, Stroke.

[24]  M. Matthay,et al.  Reasons for nonenrollment in a clinical trial of acute lung injury. , 2008, Chest.

[25]  Debra Fayter,et al.  A systematic review highlights threats to validity in studies of barriers to cancer trial participation. , 2007, Journal of clinical epidemiology.

[26]  Monika Janda,et al.  Recruiting older adults to health research studies: A systematic review , 2009, Australasian journal on ageing.

[27]  Miriam J. Johnson,et al.  A systematic review of strategies used to increase recruitment of people with cancer or organ failure into clinical trials: implications for palliative care research. , 2015, Journal of pain and symptom management.

[28]  N. Dickert,et al.  Impact of individual clinical outcomes on trial participants’ perspectives on enrollment in emergency research without consent , 2017, Clinical trials.

[29]  L. Shaw,et al.  Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): results from the pilot randomised controlled trial , 2013, Emergency Medicine Journal.

[30]  P. Reilly,et al.  Exception from informed consent for emergency research: Consulting the trauma community , 2013, The journal of trauma and acute care surgery.

[31]  P. Kudenchuk,et al.  The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent. , 2009, Annals of emergency medicine.

[32]  Daisy Elliott,et al.  Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches. , 2017, European urology.

[33]  D. Cook,et al.  Physicians declining patient enrollment in a critical care trial: a case study in thromboprophylaxis , 2013, Intensive Care Medicine.

[34]  M. Sydes,et al.  Global health trials methodological research agenda: results from a priority setting exercise , 2018, Trials.

[35]  Neal W. Dickert,et al.  Maximizing value and minimizing barriers: Patient-centered community consultation for research in emergency settings , 2017, Clinical trials.

[36]  J. Raftery,et al.  Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study. , 2008, Health technology assessment.

[37]  P. Crome,et al.  What Patients Want: Consumer Involvement in the Design of a Randomized Controlled Trial of Routine Oxygen Supplementation After Acute Stroke , 2006, Stroke.

[38]  J. Donovan,et al.  Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI) , 2016, Trials.

[39]  J. Herlitz,et al.  Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity? , 2001, Heart.

[40]  M. Meade,et al.  Premature Discontinuation of Randomized Trials in Critical and Emergency Care: A Retrospective Cohort Study , 2016, Critical care medicine.

[41]  David J Torgerson,et al.  Increasing recruitment to randomised trials: a review of randomised controlled trials , 2006, BMC medical research methodology.

[42]  A. Dadich,et al.  Effective recruitment strategies in primary care research: a systematic review. , 2012, Quality in primary care.

[43]  K. Burns,et al.  The Experience of Surrogate Decision Makers on Being Approached for Consent for Patient Participation in Research. A Multicenter Study , 2017, Annals of the American Thoracic Society.

[44]  D. Cook,et al.  Use of a screen log to audit patient recruitment into multiple randomized trials in the intensive care unit , 2000, Critical care medicine.

[45]  S. Hotte,et al.  Consistency of phase III clinical trial abstracts presented at an annual meeting of the American Society of Clinical Oncology compared with their subsequent full-text publications. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[46]  H. Selker,et al.  A community consultation survey to evaluate support for and success of the IMMEDIATE trial , 2014, Clinical trials.

[47]  P. Abboud,et al.  What determines whether patients are willing to participate in resuscitation studies requiring exception from informed consent? , 2006, Journal of Medical Ethics.

[48]  T. Santarius,et al.  Community consultation in emergency neurosurgical research: lessons from a proposed trial for patients with chronic subdural haematomas , 2013, British Journal of Neurosurgery.

[49]  I. Roberts,et al.  Effect of consent rituals on mortality in emergency care research , 2011, The Lancet.

[50]  C. Jackson,et al.  Participating in a trial in a critical situation: a qualitative study in pregnancy , 2006, Quality and Safety in Health Care.

[51]  An-Wen Chan,et al.  Search for unpublished data by systematic reviewers: an audit , 2017, BMJ Open.

[52]  D. Annane,et al.  The effect of waiving consent on enrollment in a sepsis trial , 2004, Intensive Care Medicine.

[53]  J. Collins Data and safety monitoring board issues raised in the VA Status Epilepticus Study. , 2003, Controlled clinical trials.

[54]  J. Broderick,et al.  Efficiency of enrollment in a successful phase II acute stroke clinical trial. , 2012, Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association.

[55]  Hilla Peretz,et al.  Ju n 20 03 Schrödinger ’ s Cat : The rules of engagement , 2003 .

[56]  A. Jacoby,et al.  Deciding to join a perinatal randomised controlled trial: experiences and views of pregnant women enroled in the Magpie Trial. , 2012, Midwifery.

[57]  Julia S. Benoit,et al.  Enrollment of racially/ethnically diverse participants in traumatic brain injury trials: Effect of availability of exception from informed consent , 2014, Clinical trials.

[58]  C. Camargo,et al.  Public opinion of a stroke clinical trial using exception from informed consent , 2010, International journal of emergency medicine.

[59]  Frank Sullivan,et al.  Strategies to improve recruitment to randomised controlled trials. , 2010, The Cochrane database of systematic reviews.

[60]  D. Elbourne,et al.  Views of emergency research (VERA): a qualitative study of women and their partners' views of recruitment to trials in severe postpartum haemorrhage. , 2012, Midwifery.

[61]  Jonathan C. Craig,et al.  Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review , 2010, PLoS medicine.

[62]  R. Bellomo,et al.  Screening and Study Enrolment in the Randomized Evaluation of Normal vs. Augmented Level (RENAL) Replacement Therapy Trial , 2009, Blood Purification.

[63]  W. Mortenson,et al.  Challenges and strategies pertaining to recruitment and retention of frail elderly in research studies: a systematic review. , 2014, Archives of gerontology and geriatrics.

[64]  J. Piercy,et al.  Community consultation in emergency neurotrauma research: results from a pre-protocol survey , 2013, Acta Neurochirurgica.

[65]  K. Channon,et al.  Refining the Enrolment Process in Emergency Medicine Research. , 2016, The European journal of cardiovascular medicine.

[66]  H. White,et al.  Informed consent during the clinical emergency of acute myocardial infarction (HER0-2 consent substudy): a prospective observational study , 2003, The Lancet.

[67]  S. Sidani,et al.  Strategies to Recruit Minority persons: A Systematic Review , 2014, Journal of Immigrant and Minority Health.

[68]  S. Kasner,et al.  Who will consent to emergency treatment trials for subarachnoid hemorrhage? , 2009, Academic emergency medicine : official journal of the Society for Academic Emergency Medicine.