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Preliminary development of a questionnaire measuring patient views of participation in clinical trials.

ABSTRACT: OBJECTIVE:This study aimed to develop a questionnaire for measuring patient perceptions of participating in clinical trials. Development was based on earlier research on patient views of involvement in medical care and a literature review. Patients were recruited from an ongoing clinical trial focused on cardiovascular illness and from an outpatient psychiatry department. Factor analysis was conducted on a pilot version of the questionnaire in 2016 and on a revised version in 2017. RESULTS:A total of 53 patients were recruited for the pilot study and 55 were recruited for the main study, substantially below the goal of 100 participants. Factor analysis revealed six factors measuring aspects of patients' perceptions of participating in clinical trials, including motivation, risks and benefits, the nature of the trial itself, and practical considerations, such as cost and convenience. Inter-scale correlations ranged between 0.06 and 0.64, indicating acceptable scale independence. Reliability scores (Cronbach's alphas) ranged from 0.62 to 0.85. Factor analysis results were somewhat unstable, with shared variance for several items across scales. This is likely due to the small sample sizes. In larger, more diverse patient samples, this questionnaire can be useful for measuring and incorporating patients' views into the design and execution of clinical trials.

SUBMITTER: Arnetz J

PROVIDER: S-EPMC6805544 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Preliminary development of a questionnaire measuring patient views of participation in clinical trials.

Arnetz Judith J Sudan Sukhesh S Goetz Courtney C Arnetz Bengt B Gowland Laura L Manji Suzanne S Ghosh Samiran S

BMC research notes 20191021 1

<h4>Objective</h4>This study aimed to develop a questionnaire for measuring patient perceptions of participating in clinical trials. Development was based on earlier research on patient views of involvement in medical care and a literature review. Patients were recruited from an ongoing clinical trial focused on cardiovascular illness and from an outpatient psychiatry department. Factor analysis was conducted on a pilot version of the questionnaire in 2016 and on a revised version in 2017.<h4>Re ...[more]

PMID: 31639069

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Project description:BackgroundThe increasing number of clinical research opportunities requires increasing numbers of participants in clinical trials. However, it may become increasingly problematic, as protocols have become increasingly complex. Better understanding of patients' attitudes towards their potential participation in clinical trials is essential for developing effective clinical trial recruitment strategies. In Greece, limited research has been conducted on this topic so far. This study aims to contribute to filling this gap.MethodsA cross-sectional study was conducted. Purposive sampling was used to select participants. The Greek version of a recently developed questionnaire measuring patient views on participation in clinical trials, a 27-item scale distributed into four factors, was tested. In addition, participants were asked to provide information regarding their socio-demographics. A demographic comparison was conducted.ResultsThe four-factor solution derived in our study consisted of the same 27 items and it was different from the six-factor solution that Arnetz et al. proposed. The factors risks and benefits, that consisted of 5 and 3 items respectively in the six-factor solution, were merged into one factor that consisted of 10 items in the four-factor solution. The four factors produced were Risks and benefits (ten items, α = 0,867), Patient's expectations (six items, α = 0.864), Patient's participation (five items, α = 0.827), and Cost and convenience (five items, α = 0,770). We found that demographic factors did not impact patients' opinions about clinical trials participation, except for gender. The participants reported as important for participating in clinical trial: receiving clear and adequate information (95,5 %) and being given the opportunity to ask questions (97,8 %), take part in discussions regarding their own treatment (94,6 %), and voice their concerns and opinions (91,1 %). As factors strongly associated with participants' willingness to participate in a clinical trial were reported: concerns about the risks of being in a clinical trial (87,5 %), the possible side effects of clinical trials (86,3 %), the type of treatment given in a clinical trial (83,7 %), and whether participation would improve their quality of life (QoL) (81,5 %).ConclusionsThe preliminary validation of the Greek version of the questionnaire measuring patient perceptions and expectations of participating in clinical trials demonstrated acceptable validity and reliability and could be further tested in larger samples. The findings that emerged from this study are in line with previous literature.

Project description:Background:Cancer trials often incorporate intensive imaging with Magnetic Resonance Imaging (MRI) and Positron Emission Tomography with Computerised Tomography (PET/CT), which can be physically and mentally exhausting for patients. This questionnaire study aimed to determine the aspects of imaging that affect a patient's decision to participate in clinical trials in order to inform the design of future trials that utilise imaging. This should achieve greater patient compliance and improve the patient experience. Method:A detailed questionnaire assessing patient expectation and acceptability of imaging within clinical trials was developed in collaboration with two patient representatives. The questionnaire addressed the influence of scan type, length, frequency, scheduling, invasiveness and staff support on acceptability of imaging. It was applied to three patient groups. Group 1 consisted of patients newly recruited to studies with imaging, Group 2 consisted of previous participants in studies with imaging and Group 3 consisted of patients having imaging for clinical care. Results:One hundred ninety six patients completed the questionnaires (Group 1:47; Group 2: 50 and Group 3: 99). The use of ionising radiation and number of scans required were identified as negative influences on decision to participate by 25% of Group 3 but only by 6% of Groups 1 and 2. Scan duration >30mins was perceived as a negative factor for decision to participate by all Groups (12-22%). Good communication provided by researchers in terms of discussing the study before and after reading study materials was a key factor in influencing decision to participate (>?50% in Groups 1 and 2 and?>?20% in Group 3). Conclusion:Factors relating to imaging procedures within clinical trials that affect participation have been identified with communication around study materials as the key determinant. These data will be used to influence the development of future research protocols. Modification of imaging requirements within clinical trials will improve patient tolerance and acceptability and is likely to raise recruitment.

Project description:BackgroundThe quality of life among children with idiopathic scoliosis during their adolescence has been reported to be affected by the brace itself. However, a controversy exists whether brace treated scoliotics experience a poor quality of life, thus there is a need for the development of a brace-oriented instrument, as the now-existing questionnaires that are commonly used, such as the SRS -22, take into consideration the effects of both the conservative and the surgical treatment on quality of life of scoliotic children. The aim of the present study is to assess the validity and reliability of Brace Questionnaire (BrQ), a new instrument for measuring quality of life of scoliotic adolescents who are treated conservatively with a brace.Material-methodMethodology of development involved literature review, patient and health care professionals' in-depth interviews and content validity analysis on patients. A validation study was performed on 28 brace treated scoliotic children aged between 9 and 18 years old. BrQ was assessed for the following psychometric properties: item convergent validity, floor and ceiling effects, internal consistency reliability, clinical validity and responsiveness to change.ResultsBrQ is self administrated and developmentally appropriate for ages 9 to 18 years old and is consisted of 34 Likert-scale items associated with eight domains: general health perception, physical functioning, emotional functioning, self esteem and aesthetics, vitality, school activity, bodily pain and social functioning of scoliotic children treated conservatively with a brace. The subscales of these eight dimensions can be combined to produce a total score. Higher scores mean a better quality of life. An item convergent validity >/= 0.40 was satisfied by all items in the present study. A satisfactory internal consistency reliability for the BrQ was recorded (Cronbach's alpha coefficient was 0.82). There were no floor or ceiling effects. The correlation between BrQ overall scores and mild and moderate scoliosis was statistically significant (p < 0.001), revealing high clinical validity. An increase in effect sizes for the patient with improved scoliotic curves indicates that the BrQ is responsive to change in health status.ConclusionBrQ is reliable, valid and responsive to change in adolescents with IS who are treated conservatively with a brace.

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Preliminary development of a questionnaire measuring patient views of participation in clinical trials.

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Preliminary development of a questionnaire measuring patient views of participation in clinical trials.

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