Dataset Information

Barriers to recruitment for surgical trials in head and neck oncology: a survey of trial investigators.

ABSTRACT:

Objectives

Many randomised trials in surgery suffer from recruitment rates that lag behind projected targets. We aim to identify perceived barriers to recruitment among these pioneering trials in the field of head and neck cancer surgery.

Design

Recruiting centres to all three trials (Selective Elective Neck Dissection (SEND), Positron Emission Tomography (PET)-Neck and Hyperbaric Oxygen in the Prevention of Osteoradionecrosis (HOPON)) were contacted by email by the chief investigators. Responders were asked to complete a web-based survey in order to identify the barriers to recruitment in their centre and grade each by severity.

Setting

Secondary care: 44 head and neck oncology regional referral centres.

Participants

Analysis was based on 85 responses evenly distributed between the three trials.

Results

The most commonly identified perceived barriers to recruitment (more than 50% of responders identified the item as a barrier in all the three trials) in the order of frequency were: patients consent refusal because of expressed treatment preference, patients consent refusal owing to aversion to randomisation, excess complexity/amount of information provided to patients and lack of time in clinic to accommodate research. The most severely rated of these problems was consent refusal because of the expressed treatment preference and lack of time in the clinic.

Conclusions

Our findings confirm others' work in surgery that the most significant barrier to trial recruitment in head and neck cancer surgery is the patient's preference for one arm of the trial. It may be that additional training for those taking consent may be helpful in this regard. It is also important to adequately resource busy surgical clinics to support clinical trial recruitment.

SUBMITTER: Kaur G

PROVIDER: S-EPMC3641444 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Barriers to recruitment for surgical trials in head and neck oncology: a survey of trial investigators.

Kaur Geetinder G Hutchison Iain I Mehanna Hisham H Williamson Paula P Shaw Richard R Tudur Smith Catrin C

BMJ open 20130411 4

<h4>Objectives</h4>Many randomised trials in surgery suffer from recruitment rates that lag behind projected targets. We aim to identify perceived barriers to recruitment among these pioneering trials in the field of head and neck cancer surgery.<h4>Design</h4>Recruiting centres to all three trials (Selective Elective Neck Dissection (SEND), Positron Emission Tomography (PET)-Neck and Hyperbaric Oxygen in the Prevention of Osteoradionecrosis (HOPON)) were contacted by email by the chief investig ...[more]

PMID: 23585392

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Project description:Recruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire.A literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i) trial, (ii) site, (iii) patient, (iv) clinical team, (v) information and consent and (vi) study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment.A web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes.We have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using this tool with appropriate trial-specific adaptations to monitor and improve recruitment performance in an ongoing trial or conduct the survey at trial completion to gather information on facilitators and barriers to recruitment that can form the basis of interventions and strategies to improve recruitment to future clinical trials.

Project description:BACKGROUND: The feasibility of randomized trials often depends on successful patient recruitment. Although numerous recruitment barriers have been identified it is unclear which of them complicate recruitment most. Also, most surveys have focused on the patients' perspective of recruitment barriers whereas the perspective of recruiting physicians has received less attention. Therefore, our aim was to conduct a postal survey among recruiting physicians of a multi-center trial to weigh barriers according to their impact on recruitment. METHODS: We identified any potential recruitment barriers from the literature and from our own experience with a multi-center trial of respiratory rehabilitation in patients with chronic obstructive pulmonary disease. We developed and pilot-tested a self-administered questionnaire where recruiting physicians were asked to express their agreement with statements about recruitment barriers on a Likert-type scale from 1 (full agreement with statement = very substantial recruitment barrier) to 7 (no agreement with statement = no recruitment barrier). RESULTS: 38 of 55 recruiting physicians returned questionnaires (69% response rate), of which 35 could be analyzed (64% useable response rate). Recruiting physicians reported that "time constraints" (median agreement of 3, interquartile range 2-5) had the most negative impact on recruitment followed by "difficulties including identified eligible patients" (median agreement of 5, IQR 3-6). Other barriers such as "trial design barriers", "lack of access to treatment", "individual barriers of recruiting physicians" or "insufficient training of recruiting physicians" were perceived to have little or no impact on patient recruitment. CONCLUSION: Physicians perceived time constraints as the most relevant recruitment barrier in a randomized trial. To overcome recruitment barriers interventions, that are affordable for both industry- and investigator-driven trials, need to be developed and tested in randomized trials. TRIAL REGISTRATION: ISRCTN84612310.

Dataset Information

Barriers to recruitment for surgical trials in head and neck oncology: a survey of trial investigators.

Objectives

Design

Setting

Participants

Results

Conclusions

Publications

Barriers to recruitment for surgical trials in head and neck oncology: a survey of trial investigators.

Similar Datasets

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