Determinants of patient participation in clinical studies requiring informed consent: Why patients enter a clinical trial

Verheggen, Frank W.S.M.; Nieman, Fred; Jonkers, Ruud

doi:10.1016/s0738-3991(98)00060-3

Cited by 135 publications

(115 citation statements)

References 13 publications

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“…Similar approaches toward solving trial-related problems have been found by others. Verheggen et al demonstrated patients weighing up similar issues [15], and Snowdon [21], Featherstone [23] and Cox [22] showed their subjects engaging in analogous schemes to make sense of experiences during trial participation. This strategy probably reflects a basic human problem solving behaviour, which thus remained unchanged also in these patients' anxious pursuits of hope, confidence and trust in a lifethreatening situation.…”

Section: Discussionmentioning

confidence: 99%

Participating in a cancer clinical trial? The balancing of options in the loneliness of autonomy: A grounded theory interview study

2007

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Section: Discussionmentioning

confidence: 99%

Participating in a cancer clinical trial? The balancing of options in the loneliness of autonomy: A grounded theory interview study

2007

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“…Different barriers to participation in RCTs have been suggested [3], and patients' willingness to participate in RCTs is a known limiting factor for recruitment. Factors characterizing patients declining to participate in RCTs have been identified, generally in hypothetical trials [3,7,8], but also using a qualitative approach based on patient interviews [9,10]. However, the majority of available studies were performed in cancer or cardiovascular diseases [3].…”

Section: Introductionmentioning

confidence: 99%

The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment

Frobell

Lohmander

Roos

2007

Contemporary Clinical Trials

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This is an author produced version of a paper published Contemporary clinical trials. This paper has been peerreviewed but does not include the final publisher proofcorrections or journal pagination. 2 AbstractAims --To determine the number of patients needed to be screened (NNS) and allocated (NNA) to include one participant into a randomized clinical trial (RCT), and to compare the characteristics of patients accepting or declining participation in the RCT.Methods --The recruitment process of an ongoing multicenter RCT, comparing surgical and nonsurgical interventions after acute anterior cruciate ligament (ACL) injury of the knee is described. We use the known concept Number Needed to Screen (NNS) and introduce the new concept NumberNeeded to Allocate (NNA) as variables to support a priori sample size calculations of future investigations.Results --560 patients were screened to identify 162 patients (29%) eligible for inclusion in the RCT. 41of those declined participation for various reasons, the most common being unwillingness to undergo surgery (n=23) or unwillingness to risk conservative treatment (n=8). 19 patients were excluded after MRI assessment or arthroscopy. Thus, 102 (18%) patients were allocated to one of the two treatments in the RCT. The NNS was 5.5 individuals with an acute knee injury, and the NNA was 1.6 individuals eligible for inclusion, to include 1 patient in the RCT. Patients declining to participate in the RCT were more frequently self-employed and less frequently injured in sports activities than those accepting RCT participation.Conclusions --We suggest that the a priori sample size calculation needs to be multiplied by at least 5.5to provide an estimate of the number needed to screen, or 1.6 to provide an estimate of the number needed to allocate in order to include the desired number of patients in a trial comparing surgical and non-surgical treatment of the ACL injured patient.

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“…Patient acceptance of a referral may depend on such factors and upon others as well, e.g., the time required and the perceived likelihood of treatment success. Also, patients are more likely to volunteer for a clinical trial addressing an existing critical health problem than one targeting preventive care (such as smoking cessation) [39][40][41][42]. These differences complicate any comparison of recruitment results across different clinical and research domains.…”

Section: Recruitment Resultsmentioning

confidence: 99%

Electronic health records as a tool for recruitment of participants' clinical effectiveness research: lessons learned from tobacco cessation

Fraser

Christiansen²,

Adsit³

et al. 2012

Behav. Med. Pract. Policy Res.

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Translating tobacco dependence treatments that are effective in research settings into real-world clinical settings remains challenging. Electronic health record (EHR) technology can facilitate this process. This paper describes the accomplishments and lessons learned from a translational team science (clinic/research) approach to the development of an EHR tool for participant recruitment and clinic engagement in tobacco cessation research. All team stakeholdersresearch, clinical, and IT-were engaged in the design and planning of the project. Results over the first 17 months of the study showed that over one half of all smokers, coming in for any type of clinic appointment, were offered participation in the study, a very high level of adherent use of the EHR. Study recruitment over this period was 1,071 individuals, over 12 % of smokers in the participating clinics. KEYWORDSElectronic health records, Recruitment, Tobacco cessation BACKGROUND While research advances have extended the effectiveness and reach of tobacco dependence treatment over the past two decades, the disjointed process for bringing laboratory advances into clinical practice has often resulted in interventions that yield diminished effects in real world use [1][2][3][4][5]. One approach to address this "translation gap" is to develop and test interventions in real world clinical settings whenever possible. However, research conducted in these settings poses challenges that can compromise internal validity (e.g., reduce the accurate assessment of outcomes) or render the intervention context unrepresentative of real world conditions (e.g., due to burdensome consent processes, confidentiality regulations, and assessment burdens). Despite these limitations, strategies are available that can foster enhanced translation. For instance, in the case of interventions designed for use in healthcare settings, research designs can enhance translation by leveraging existing clinic infrastructure and

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Determinants of patient participation in clinical studies requiring informed consent: Why patients enter a clinical trial

Cited by 135 publications

References 13 publications

Participating in a cancer clinical trial? The balancing of options in the loneliness of autonomy: A grounded theory interview study

Participating in a cancer clinical trial? The balancing of options in the loneliness of autonomy: A grounded theory interview study

The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment

Electronic health records as a tool for recruitment of participants' clinical effectiveness research: lessons learned from tobacco cessation

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