Dataset Information

Optimising recruitment into trials using an internal pilot.

ABSTRACT:

Background

Recruitment to trials can be difficult. Despite careful planning and research that outlines ways to improve recruitment, many trials do not achieve their target on time and require extensions of funding or time.

Methods

We describe a trial in which an internal pilot with embedded qualitative research was used to improve recruitment processes and inform recruitment projections for the main trial. At the end of the pilot, it was clear that the sample size would not be met on time. Three steps were taken to optimise recruitment: (1) adjustments were made to the recruitment process using information from the qualitative work done in the pilot and advice from a patient and public involvement group, (2) additional recruiting sites were included based on site feasibility assessments and (3) a projection equation was used to estimate recruitment at each site and overall trial recruitment.

Results

Qualitative work during the pilot phase allowed us to develop strategies to optimise recruitment during the main trial, which were incorporated into patient information packs, the standard operating procedures and training sessions with recruiters. From our experience of feasibility assessments, we developed a checklist of recommended considerations for feasibility assessments. For recruitment projections, we developed a four-stage projection equation that estimates the number of participants recruited using a conversion rate of the number randomised divided by the number screened.

Conclusions

This work provides recommendations for feasibility assessments and an easy-to-use projection tool, which can be applied to other trials to help ensure they reach the required sample size.

Trial registration

ISRCTN, ISRCTN92545361 . Registered on 6 September 2016.

SUBMITTER: Bertram W

PROVIDER: S-EPMC6458725 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Publications

Optimising recruitment into trials using an internal pilot.

Bertram W W Moore A A Wylde V V Gooberman-Hill R R

Trials 20190411 1

<h4>Background</h4>Recruitment to trials can be difficult. Despite careful planning and research that outlines ways to improve recruitment, many trials do not achieve their target on time and require extensions of funding or time.<h4>Methods</h4>We describe a trial in which an internal pilot with embedded qualitative research was used to improve recruitment processes and inform recruitment projections for the main trial. At the end of the pilot, it was clear that the sample size would not be met ...[more]

PMID: 30971279

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Project description:BackgroundSlower than planned recruitment is a major factor contributing to the delay or failure of randomised controlled trials to report on time. There is a limited evidence base regarding the optimisation of recruitment strategies. Here we performed an observational review of our experience in recruitment for two large randomised controlled trials for people with secondary progressive multiple sclerosis. We aimed to explicitly determine those factors which can facilitate trial recruitment in progressive neurodegenerative disease.MethodsRecruitment data from the sequential MS-SMART [NCT01910259] and MS-STAT2 [NCT03387670] UK randomised controlled trials was reviewed from the largest recruiting site, University College London (UCL). The trial population was similar which allowed comparison over the two recruitment periods of 2015-2016 and 2018-2021. This included sources of referral, progress through stages of recruitment, reasons for participant ineligibility and the impact of publicity events upon recruitment.ResultsIn MS-SMART, 18% of patients contacted were enrolled, compared to 27% for MS-STAT2. Online registration of interest portals provided the greatest number of referrals (76% in MS-SMART, and 51% in MS-STAT2), with publicity in national media outlets producing a demonstrable increase in the number of potential participants. The introduction of an online self-screening questionnaire for MS-STAT2 resulted in 67% of potential participants (3080 of 4605) automatically determining their own ineligibility. In both studies, however, around 60% of those directly telephoned to discuss the study were not eligible, with difficulties related to travel to trial visits, or excluded medication, being the most common issues. Eighty-four percent of those deemed potentially eligible following telephone calls were enrolled in the MS-STAT2 study, compared to only 55% for MS-SMART.ConclusionsThrough a detailed review of recruiting participants at the largest centre into two large randomised controlled trials with similar entry criteria, we have identified a number of approaches that may improve recruitment efficiency. We highlight here the importance of mandatory online self-screening questionnaires, a coordinated publicity campaign, and simple interventions such as eligibility checklists and appointment reminders. Recruitment approaches should be further assessed through a studies within a trial (SWAT) design.Trial registrationMS-SMART: NCT01910259 ; registered July 2013 and MS-STAT2: NCT03387670 ; registered Jan 2018.

Project description:BackgroundAs part of the internal pilot of the EMPOWER trial investigating the second-line antiemetic therapies in severe emesis in pregnancy ( https://www.isrctn.com/ISRCTN16924692 ), a qualitative study of women's views was carried out, to improve our understanding of why women did, or did not, consent to participation in the trial. Interviews were also conducted with site research staff, to broaden our analysis and explore other factors affecting recruitment.MethodsThe sample comprised women who accepted or declined trial participation (n=21) and site research staff (n=22). A structured topic guide was used, in four email interviews and 17 telephone interviews with women, and semi-structured telephone interviews were carried out with staff. Of the women interviewed, seven had declined trial participation, and of the staff interviewed, 16 were research midwives/research nurses and six were principal investigators. All transcripts were checked for accuracy, anonymised and entered into NVIVO12 for indexing and retrieval. Data was analysed using a reflexive thematic analytic approach. In total, 72 codes were generated from the thematic analysis, and 36 from each sample group.ResultsThree key themes based on all the interviews were (a) the diversity of recruitment pathways and boundaries of care, (b) the impact of trial complexity on recruitment and staff morale and (c) the ethics of caring for a patient with emesis. Ethical issues discussed included the use of double dummy and time to treat, particularly those suffering severely from the effects of nausea and vomiting. To illustrate these themes, staff perspectives are given more prominence.ConclusionsThe main reason the trial was stopped related to the high proportion of women ineligible for recruitment due to prior treatment with study drug(s) because of unanticipated changes in clinical practice. The qualitative results also demonstrate the impact of the trial on women and staff and highlight how the diversity of referral pathways, boundaries of care and the complexity of the trial and protocol resulted in additional barriers to successful trial recruitment. Qualitative work in pilot and feasibility studies of a clinical trial is recommended, to evaluate whether recruitment strategies remain viable in unanticipated contexts.Trial registrationTrial registration number ISRCTN16924692 . Date: 08/01/2018.

Project description:BackgroundRecruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome recruitment obstacles. This paper reports on an intervention-the QuinteT Recruitment Intervention (QRI)-to optimise recruitment within a randomised feasibility study of surgical treatments for patients with Dupuytren's contracture (the HAND-1 study).MethodsThe QRI was introduced in 2-phases: phase 1 sought to understand the recruitment challenges by interviewing trial staff, scrutinising screening logs and analysing audio-recorded patient consultations; in phase 2 a tailored plan of action consisting of recruiter feedback and training was delivered to address the identified challenges.ResultsTwo key recruitment obstacles emerged: (1) issues with the recruitment pathway, in particular methods to identify potentially eligible patients and (2) equipoise of recruiters and patients. These were addressed by liaising with centres to share good practice and refine their pathway and by providing bespoke feedback and training on consent discussions to individual recruiters and centres whilst recruitment was ongoing. The HAND-1 study subsequently achieved its recruitment target.ConclusionsTransferable lessons learnt from the QRI in the feasibility study will be implemented in the definitive RCT, enabling a "head start" in the tackling of wider issues around screening methods and consent discussions in the set up/early recruitment study phases, with ongoing QRI addressing specific issues with new centres and recruiters. Findings from this study are likely to be relevant to other surgical and similar trials that are anticipated to encounter issues around patient and recruiter equipoise of treatments and variation in recruitment pathways across centres. The study also highlights the value of feasibility studies in fine-tuning design and conduct issues for definitive RCTs. Embedding a QRI in an RCT, at feasibility or main stage, offers an opportunity for a detailed and nuanced understanding of key recruitment challenges and the chance to address them in "real-time" as recruitment proceeds.

Project description:BACKGROUND:Colorectal cancer (CRC) is the third most common type of cancer and the second leading cause of cancer death in the United States. About one in three adults in the United States is not getting the CRC screening as recommended. Internal medicine residents are deficient in CRC screening knowledge. OBJECTIVE:The objective of our study was to assess the improvement in internal medicine residents' CRC screening knowledge via a pilot approach using a smartphone app. METHODS:We designed a questionnaire based on the CRC screening guidelines of the American Cancer Society, American College of Gastroenterology, and US Preventive Services Task Force. We emailed the questionnaire via a SurveyMonkey link to all the residents of an internal medicine department to assess their knowledge of CRC screening guidelines. Then we designed an educational intervention in the form of a smartphone app containing all the knowledge about the CRC screening guidelines. The residents were introduced to the app and asked to download it onto their smartphones. We repeated the survey to test for changes in the residents' knowledge after publication of the smartphone app and compared the responses with the previous survey. We applied the Pearson chi-square test and the Fisher exact test to look for statistical significance. RESULTS:A total of 50 residents completed the first survey and 41 completed the second survey after publication of the app. Areas of CRC screening that showed statistically significant improvement (P<.05) were age at which CRC screening was started in African Americans, preventive tests being ordered first, identification of CRC screening tests, identification of preventive and detection methods, following up positive tests with colonoscopy, follow-up after colonoscopy findings, and CRC surveillance in diseases. CONCLUSIONS:In this modern era of smartphones and gadgets, developing a smartphone-based app or educational tool is a novel idea and can help improve residents' knowledge about CRC screening.

Project description:Background: Physical activity (PA) and exercise are widely documented as key components in the management of cystic fibrosis (CF). In recent years there have been significant improvements in telehealth, in particular; wearable technology, smartphone use and remote monitoring, all of which may have potential to impact on PA in adults with CF. The objective of this pilot randomised trial is to explore the effect of wearable technology, which is remotely monitored, combined with personalised text message feedback and goal setting, on PA in adults with CF. Secondary endpoints include lung function, aerobic capacity, quality of life, body composition, wellbeing and sleep. Methods: This is a pilot randomised trial which will be conducted at the University Hospital Limerick, Ireland. Participants will be randomised to the intervention or active comparator after their baseline assessment. The 12-week intervention will consist of wearable technology (Fitbit Charge 2) which is linked to an online monitoring system (Fitabase) that enables the physiotherapist to remotely monitor participant data. The CF physiotherapist will set individualised PA goals with each participant at baseline and will send text message feedback each week. The text messages will be personalised, one-way texts with positive reinforcement on step count attained by the participant. The active comparator group will receive this wearable technology which is also linked to Fitabase; however, no feedback will be provided to participants in this group. Both groups will be re-assessed at 12 weeks. After this point, both groups will continue with the Fitbit alone for a further 12 weeks. Both groups will be re-assessed at 24 weeks. A semi structured interview will assess satisfaction and acceptability of the intervention. Discussion: This is a novel concept which utilises modern technology, remote monitoring and personalised feedback to investigate the effect on PA in adults with CF. Trial registration: ClinicalTrials.gov NCT03672058 (14/09/2018).

Project description:IntroductionOptimising abdominal aortic aneurysm surveillance intervals will improve current surveillance programmes. To the author's knowledge, no known study has exclusively asked patient opinion with regards to their surveillance interval. The aim of this study was to therefore determine a patient's perspective of their optimal intervals, encouraging shared decision-making and creating a patient-focused service.MethodsFifty patients, currently under abdominal aortic aneurysm surveillance, were interviewed. Patients were asked their opinions before and after seeing a patient decision aid. A patient decision aid presents information of risk in an easy-to-understand format. This specific patient decision aid, designed and created for this study, informed patients of the 'risk of exceeding the 5.5 cm surgical threshold' with regards to various surveillance intervals. The chosen optimal surveillance interval was recorded for each patient, and a median interval was calculated for each abdominal aortic aneurysm group. Groups were categorised based upon maximum aortic diameter (3.0-3.4 cm, 3.5-3.9 cm, 4.0-4.4 cm and 4.5-4.9 cm).ResultsAfter assessing the patient decision aid, the median surveillance interval calculated for each abdominal aortic aneurysm group was 24 months (3.0-3.4 cm), 12 months (3.5-3.9 cm), 12 months (4.0-4.4 cm) and 6 months (4.5-4.9 cm), respectively. The majority of patients (78%, n = 39) agreed that the patient decision aid was a useful tool to help make an informed choice.ConclusionOverall, patients in abdominal aortic aneurysm groups 3.0-3.4 cm and 4.5-4.9 cm would choose to lengthen abdominal aortic aneurysm surveillance intervals. Lengthening the current surveillance intervals to 24 months (currently 12 months) for abdominal aortic aneurysm group 3.0-3.4 cm and to 6 months (currently 3 months) for abdominal aortic aneurysm group 4.5-4.9 cm would not only increase capacity but also reflect the needs and wishes of those using the National Health Service. The use of a patient decision aid is an effective way of communicating, to the patient, the risk of the proposed changes and thus alleviating potential anxiety.

Dataset Information

Optimising recruitment into trials using an internal pilot.

Background

Methods

Results

Conclusions

Trial registration

Publications

Optimising recruitment into trials using an internal pilot.

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