scholarly journals Translation and Validation of the Greek Version of a Questionnaire Measuring Patient Views on Participation in Clinical Trials

2021 ◽  
Author(s):  
Dimitrios Karampatakis ◽  
Angeliki Kakavouti-Doudos ◽  
Panagiotis Oikonomidis ◽  
Polychronis Voultsos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Validity And Reliability ◽  
Greek Version ◽  
Factor Solution ◽  
Cross Sectional ◽  
Risks And Benefits ◽  
Patient Views

Abstract 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%).ConclusionThe 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.

scholarly journals Translation and validation of the greek version of a questionnaire measuring patient views on participation in clinical trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dimitrios Karampatakis ◽  
Angeliki Kakavouti-Doudos ◽  
Panagiotis Oikonomidis ◽  
Polychronis Voultsos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Validity And Reliability ◽  
Greek Version ◽  
Factor Solution ◽  
Cross Sectional ◽  
Risks And Benefits ◽  
Patient Views

Abstract Background The 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. Methods A 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. Results The 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 %). Conclusions The 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.

scholarly journals Willingness to Participate in Vaccine-Related Clinical Trials among Older Adults

2018 ◽  
Vol 15 (8) ◽  
pp. 1743 ◽  
Author(s):  
Divyanshu Raheja ◽  
Evelyn Davila ◽  
Eric Johnson ◽  
Rijalda Deović ◽  
Michele Paine ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Clinical Research ◽  
Elderly Person ◽  
The Elderly ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Cross Sectional ◽  
Convenience Sample ◽  
Research Findings

The purpose of this study is to understand among a convenience sample of 400 adults aged 60 years of age or older (1) reasons for being willing or unwilling to participate in a vaccine clinical research study and (2) overall perceptions about vaccine clinical research. A cross-sectional study using a sample of older adults residing in the metro-Atlanta area and surrounding neighborhoods was conducted. The study questionnaire contained 37 questions, including questions about socio-demographics and perceptions about clinical trial processes. Statistical analysis was conducted using logistic regression. The adjusted modeling results indicated that sex, distance to research clinic, and being informed about the research findings played a role in the likelihood of an elderly person participating in a vaccine study. Males were more likely to participate in clinical trials as compared to females (OR: 2.486; CI: 1.042–5.934). Most participants were willing to travel up to 25 miles from the research clinic. Of the respondents, 45% were unlikely to participate if the results of the current trial are not shared. Improving access to clinical trials in terms of distance traveled and ensuring streamlined processes to inform participants about the results of the trial in the future would increase willingness to participate in vaccine clinical trials. The survey could serve as a useful tool for conducting vaccine studies and other clinical trials by understanding the barriers specific to the elderly.

scholarly journals Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053096
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

ObjectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.DesignCross-sectional study.SettingThe COVID-19 clinical trial landscape.Participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.Main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.ResultsFollowing automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n=25) followed by journal articles (n=18), and results on a registry (n=2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%.ConclusionCOVID-19 trials completed during the first 6 months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.

Participation of elderly gynecological cancer patients in clinical trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21520-e21520
Author(s):  
Katharina Prieske ◽  
Fabian Trillsch ◽  
Gulten Oskay-Oezcelik ◽  
Radoslav Chekerov ◽  
Eva-Maria Schoening ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Gynecological Cancer ◽  
Educational Background ◽  
General Information ◽  
Willingness To Participate ◽  
Study Participation ◽  
Long Distance ◽  
Cross Sectional ◽  
Potential Study

e21520 Background: Elderly patients (pts) are underrepresented in clinical trials in gynecological cancer, even though they are disproportionally often affected. This study aimed to evaluate disposition and apprehension of elderly pts towards study participation. Methods: 112 elderly gynecological cancer pts (median age 70; range 65-92) were surveyed in a multicenter cross-sectional study. Besides fitness, state of disease, education and domestic situation, questions aimed at the general willingness to participate in a clinical trial. Personal reasons for rejection and suspected advantages/disadvantages that might evolve from participation were inquired. Results: Willingness to participate in a study was generally high (66.1%, 74/112). 42/112 (37.5%) had given their consent to participation in a study before, 12.5% (6/48) refused even though they were offered participation. Reasons for potential study participation were: ‘better monitoring of the disease’ (51/112), ‘better medical care’ (35/112), ‘to help medical research’ (31/112), ‘better medication’ (27/112) and ‘because of my doctor’s recommendation’ (17/112). Reasons for potential refusal were: ‘too time consuming’ (19/112), ‘fear of side effects’ (17/112), ‘misuse as experimental animal’ (14/112), ‘long distance to clinic’ (11/112) and ‘too little or unclear information’ (7/112). 26.1% (29/112) of pts stated, that they had ‘no objection’ against study participation. The question if pts anticipated having a longer life due to study participation was answered with ‘yes’ or ‘rather yes’ in 33.9% (38/112), 23.2% answered ‘no’ or ‘rather no’ (23.2% undecided). No relation between willingness to participate in a study and general fitness (p = 0.311), education (p = 0.631) or domestic situation (p = 0.195) could be observed. However, with increasing age, willingness decreased (p = 0.029). Conclusions: Elderly pts are generally willing to participate in clinical studies regardless of their fitness or educational background. Benefits of participation seem to be unclear among a majority of potential study participants. Therefore it might be decisive to provide more general information regarding benefits and safety for the elderly pts in a clinical trial.

scholarly journals Knowledge of medical students on clinical trials

2019 ◽  
Vol 8 (7) ◽  
pp. 1484
Author(s):  
Ravi Shankar Kanna ◽  
Jagadeesh Alla ◽  
Krishnakanth K.
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Students ◽  
Basic Research ◽  
Thinking Skills ◽  
Cross Sectional Study ◽  
Critical Thinking Skills ◽  
School Students ◽  
Cross Sectional ◽  
Institutional Ethics

Background: Basic research can help medical school students improve critical thinking skills required by medical practice. In this era of evidence-based medicine, the combination of medical education with clinical research is the key to ensure scientific discoveries are translated into clinical practice. This study’s objective was to know the awareness about clinical trials among undergraduate medical students.Methods: After obtaining approval from the Institutional Ethics Committee of NRI Academy of Medical Sciences, Guntur, India, this cross sectional study was conducted in second year medical students after taking their consent. A sample of 90was considered for statistical analysis. A structured questionnaire was used to measure the objective of this study, which had general, regulatory and ethical questions related to clinical trials. Qualitative data variables were expressed by using frequency and Percentage (%).Results: Out of 90 students, it was observed that in the general questions category, 70% of students were aware of the purpose of conducting clinical trials, 50% were aware of the pre-requisites for a participant before participating in a clinical trial and 50% were aware of the parameters evaluated in a clinical trial. 95% of students did not know the response for regulatory questions. The students’ awareness regarding ethics related to clinical trials was better than the other two categories.Conclusions: The overall awareness of clinical trials was low among students though they demonstrated good awareness regarding few aspects of clinical trials.

Willingness of patients with pancreatic cancer to participate in clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4055-4055
Author(s):  
Pelin Cinar ◽  
Anitra W. Talley ◽  
Jimmy Hwang ◽  
Daniel Paul Dohan ◽  
Margaret A. Tempero
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Trial Participation ◽  
Trial Recruitment ◽  
Chi Square ◽  
Cross Sectional ◽  
Recruitment Methods ◽  
Clinical Trial Recruitment

4055 Background: Recruitment of oncology patients into clinical trials continues to be a challenge as <5% of patients are accrued. Low accrual rates may be due to reduced awareness of trial availability and eligibility by physicians/patients. Our objective was to study the attitudes of patients with pancreatic cancer (PC) regarding clinical trial participation and to identify possible barriers to recruitment. Methods: In this cross-sectional study, we collaborated with Pancreatic Cancer Action Network (PanCAN) and invited patients with PC or their caregivers to complete a survey. The survey that was developed consisted of 22 questions and inquired about patients’ previous clinical trial enrollment experiences and their views on participation. The surveys were collected over a 6-month period via the PanCAN website and regional meetings. Comparison analyses between groups were done by Chi-square and Fisher’s test using STATA software. Results: Of the390 surveys received, 149 were included in the final analyses. 30% of the patients were offered to participate in a trial by their physicians. When asked to participate, 62% of the patients agreed. Of the patients who were not enrolled in a clinical trial, 61% were offered to participate in a trial but did not agree. This suggests that these patients were eligible to participate but declined. Conclusions: Majority of the patients with pancreatic cancer were not offered to participate in clinical trials by their physicians but would have agreed if asked. While low clinical trial recruitment rates for PC may be multifactorial, further research may focus on the important role of physicians in clinical trial recruitment efforts. [Table: see text]

scholarly journals A Validation Study of The Greek Version of The Toronto Empathy Questionnaire In Medical Students And A Measurement of Their Empathy

2021 ◽  
Author(s):  
Polychronis Voultsos ◽  
Fotios Chatzinikolaou ◽  
Angeliki Papana ◽  
Aspasia Deliliga
Keyword(s):  
Medical Students ◽  
Cross Sectional Study ◽  
Validity And Reliability ◽  
Greek Version ◽  
Cross Sectional ◽  
Preliminary Validation ◽  
Significant Difference ◽  
The Family ◽  
Empathy Scale ◽  
Key Driver

Abstract Aims and objectives: Empathy is an important key driver of any therapeutic relationship. It is beneficial not only to the patients, but also to physicians. Enhancing physician’s empathy should be an important goal of medical education. As there is a literature gap regarding the topic of empathy among medical students in Greece, this study aims to contribute to filling this gap.Methods: A cross-sectional study was conducted. The (validated in Greece) Greek version of Toronto 52‐item empathy 6-point Likert-scale was administered to all the medical students in the Aristotle University of Thessaloniki, in Greece. In addition, participants were asked to provide information regarding their socio-demographics. A demographic comparison was conducted.Results: The preliminary validation of the Greek version of the Toronto Composite Empathy Scale (TCES) demonstrated acceptable validity and reliability among medical students and could be further tested in larger samples of medical students. The overall reliability analysis of the TCES questionnaire is high (Cronbach's α = 0.895, Sig. from Hotelling’s T-Squared Test < 0.000). The mean total score of empathy showed that students have a moderately high empathy. The 52‐item TCES, 26 for the personal (Per) setting and another 26 for professional (Pro) life, equally divided into cognitive (Cog) and emotional (Emo) empathy in each case. It was found that there is a statistically significant difference in means between the Per-Cog and Per-Emo settings (Sig < 0.001), the Pro-Cog and Pro-Emo (Sig < 0.001), the Per-Cog and Pro-Cog (Sig = 0.004), and the Per-Emo and Pro-Emo (Sig < 0.001). Females had significantly higher empathy scores (mean score 208.04) than males (mean score 192.5) on the Per-Cognitive, Per-Emo and Pro-Emo subscales. Furthermore, a positive correlation was found between empathy and factors such as love for animals, interest in medical ethics, belief in God, having an ill person in the family, class year or carrier intention. Conclusions: The Toronto Composite Empathy Scale (TCES) is applicable to medical students. For the most part our findings were consistent with previous literature. However, we identified some nuances that might draw researchers’ attention.

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