Assessing Patient Participation Burden Based on Protocol Design Characteristics

2019 ◽  
pp. 216847901986728
Author(s):  
Kenneth Getz ◽  
Venkat Sethuraman ◽  
Jessica Rine ◽  
Yaritza Peña ◽  
Sharma Ramanathan ◽  
...  

Background: Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials. Methods: This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures. The association and relationship between overall patient burden—derived from aggregating mean perceived burden ratings for individual procedures—and performance (eg, screen failure and retention rates, clinical trial cycle times) for a cross-sectional sample of 137 individual protocols was assessed. Descriptive statistics, significance tests, and univariate analyses were performed. Results: Strong positive, statistically significant associations were observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit. Conclusions: The study results suggest a new and viable approach to optimize protocol design and improve patient engagement.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sonika Sethi ◽  
Aditi Kumar ◽  
Anandadeep Mandal ◽  
Mohammed Shaikh ◽  
Claire A. Hall ◽  
...  

Abstract Background Developing a safe and effective vaccine will be the principal way of controlling the COVID-19 pandemic. However, current COVID-19 vaccination trials are not adequately representing a diverse participant population in terms of age, ethnicity and comorbidities. Achieving the representative recruitment targets that are adequately powered to the study remains one of the greatest challenges in clinical trial management. To ensure accuracy and generalisability of the safety and efficacy conclusions generated by clinical trials, it is crucial to recruit patient cohorts as representative as possible of the future target population. Missing these targets can lead to reduced validity of the study results and can often slow down drug development leading to costly delays. Objective This study explores the key factors related to perceptions and participation in vaccination trials. Methods This study involved an anonymous cross-sectional online survey circulated across the UK. Statistical analysis was done in six phases. Multi-nominal logistic models examined demographic and geographic factors that may impact vaccine uptake. Results The survey had 4884 participants of which 9.44% were Black Asian Minority Ethnic (BAME). Overall, 2020 (41.4%) respondents were interested in participating in vaccine trials; 27.6% of the respondents were not interested and 31.1% were unsure. The most interested groups were male (OR = 1.29), graduates (OR = 1.28), the 40–49 and 50–59 age groups (OR = 1.88 and OR = 1.46 respectively) and those with no health issues (OR = 1.06). The least interested groups were BAME (OR = 0.43), those from villages and small towns (OR = 0.66 and 0.54 respectively) and those aged 70 and above (OR = 1.11). Conclusions In order to have a vaccination that is generalisable to the entire population, greater work needs to be done in engaging a diverse cohort of participants. Public health campaigns need to be targeted in improving trial recruitment rates for the elderly, BAME community and the less educated rural population.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Asphat Muposhi ◽  
Brighton Nyagadza ◽  
Chengedzai Mafini

PurposeFashion designers in South Africa remain ambivalent in embracing sustainable fashion. This study examines the role of neutralisation techniques on attitude towards sustainable fashion. The study was conducted in South Africa, an emerging market known for water scarcity and pollution emanating from the textile industry.Design/methodology/approachA structured questionnaire was used to collect cross-sectional data from a sample of 590 fashion designers using a web-based online survey. Study constructs were drawn from the neutralisation theory and theory of planned behaviour.FindingsStandard multiple regression analysis results identified denial of injury, appeal to higher loyalties and external locus of control as the major rationalisation techniques influencing South African designers' negative attitudes towards sustainable fashion.Research limitations/implicationsResearch was conducted in South Africa where the concept of sustainable fashion is still at developmental stages. The generalisation of the study findings may be enhanced by extending the study to other markets with a fully developed market for sustainable fashion.Practical implicationsThe study results underscore the necessity of reducing social, structural and institutional barriers associated with the adoption of sustainable fashion. This study provides input towards efforts to develop attitude change strategies to stimulate designers to embrace sustainable fashion.Originality/valueThe research study contributes to theory, practice and future research.


2020 ◽  
Author(s):  
Sarina Rebecca Chaiken ◽  
Lisa Han ◽  
Blair G Darney ◽  
Leo Han

BACKGROUND The majority of patients use the internet to search for health information. While there is a vast repository of searchable information online, much of the content is unregulated and therefore potentially incorrect, conflicting, or confusing. Abortion information online is particularly prone to being inaccurate as anti-choice websites publish purposefully misleading information in formats that appear as neutral resources. To understand how anti-choice websites appear neutral, we need to understand the specific website features of anti-choice features that impart trust to viewers. OBJECTIVE We sought to identify characteristics of false or misleading abortion websites that make these websites appear trustworthy to the public. METHODS We conducted a cross-sectional study using Amazon.com Inc’s Mechanical Turk platform. We used validated questionnaires to ask participants to rate eleven anti-choice sites and one neutral site identified by experts, focusing on site content, creators, and design. We collected socio-demographic data and participant views on abortion. We used a composite measure of “mean overall trust” as our primary outcome. Using correlation matrices, we determined which website characteristics were most associated with overall trust. Finally, we used linear regression to identify participant characteristics associated with overall trust. RESULTS Our analytic sample included 498 participants ranging from ages 22 to 70, 50.1% of whom identified as female. Across eleven anti-choice sites, creator trust (“I believe that the creators of this site are honest and trustworthy”) had the highest correlation coefficient with overall trust (0.70). Professional appearance (0.59), look and feel (0.59), perception that the information is created by experts (0.59), association with a trustworthy organization (0.58), valued features and functionalities (0.54), and interactive capabilities (0.52) all demonstrated strong relationships with overall trust. At the individual level, pro-choice leaning was associated with higher overall trust of the neutral site (B: -0.43, CI: -0.87, 0.01) and lower overall trust of the anti-choice sites (B: 0.52, CI: 0.05, .99). CONCLUSIONS The overall trustworthiness of anti-choice websites is most associated with design characteristics and perceived trustworthiness of the site creator. Those who believe that access to abortion should be limited are more likely to trust anti-choice websites.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Jin Li ◽  
Linlin Chai ◽  
Chanchai Tangpong ◽  
Michelle Hong ◽  
Rodney D. Traub

Purpose This study aims to examine empirically the existence of four classical and four emerging buyer–supplier relationship (BSR) types and how they differ in terms of behavioral dynamics and performance measures. Design/methodology/approach This study uses an online survey to collect data from 371 purchasing managers in the USA. Findings A cluster analysis statistically supports the existence of five of these eight BSR types, including strategic/bilateral partnership, market/discrete, supplier-led collaboration, captive supplier/buyer dominant and captive buyer/supplier dominant BSRs. Further, ANOVA tests show that these five BSRs differ in terms of behavioral outcomes and performance measures. Research limitations/implications This study is based on a cross-sectional survey so it cannot examine how these BSR types may evolve over time, and it is not suitable to examine some rare types of BSRs. In addition, this study does not consider contextual factors that may moderate the influence of BSR types on the behavioral dynamics and performance measures. Practical implications Managers should consider the potential to be able to develop and enhance a strategic/bilateral relationship with their supply chain partners, which in at least some circumstances can lead to superior performance results. Similar observations can be made with respect to supplier-led and, to a lesser degree, buyer-led collaboration. Originality/value Most existing research of the BSR types is largely a product of theoretical classifications, and there is also a lack of research of their performance implications. This study fills these gaps in the literature.


2022 ◽  
Vol 21 (1) ◽  
Author(s):  
Wei Lee ◽  
Sungwon Chang ◽  
Michelle DiGiacomo ◽  
Brian Draper ◽  
Meera R. Agar ◽  
...  

Abstract Background Depression is prevalent in people with very poor prognoses (days to weeks). Clinical practices and perceptions of palliative physicians towards depression care have not been characterised in this setting. The objective of this study was to characterise current palliative clinicians’ reported practices and perceptions in depression screening, assessment and management in the very poor prognosis setting. Methods In this cross-sectional cohort study, 72 palliative physicians and 32 psychiatrists were recruited from Australian and New Zealand Society of Palliative Medicine and Royal Australian and New Zealand College of Psychiatrists between February and July 2020 using a 23-item anonymous online survey. Results Only palliative physicians results were reported due to poor psychiatry representation. Palliative physicians perceived depression care in this setting to be complex and challenging. 40.0% reported screening for depression. All experienced uncertainty when assessing depression aetiology. Approaches to somatic symptom assessment varied. Physicians were generally less likely to intervene for depression than in the better prognosis setting. Most reported barriers to care included the perceived lack of rapidly effective therapeutic options (77.3%), concerns of patient burden and intolerance (71.2%), and the complexity in diagnostic differentiation (53.0%). 66.7% desired better collaboration between palliative care and psychiatry. Conclusions Palliative physicians perceived depression care in patients with very poor prognoses to be complex and challenging. The lack of screening, variations in assessment approaches, and the reduced likelihood of intervening in comparison to the better prognosis setting necessitate better collaboration between palliative care and psychiatry in service delivery, training and research.


2021 ◽  
Author(s):  
Sonika Sethi ◽  
Aditi Kumar ◽  
Anandadeep Mandal ◽  
Mohammed Shaikh ◽  
Claire Anne Hall ◽  
...  

Abstract Background: Developing a safe and effective vaccine will be the principal way of controlling the COVID-19 pandemic. However, current COVID-19 vaccination trials are not adequately representing a diverse participant population in terms of age, ethnicity and comorbidities. Achieving the representative recruitment targets that are adequately powered to the study remains one of the greatest challenges in clinical trial management. To ensure accuracy and generalizability of the safety and efficacy conclusions generated by clinical trials, it is crucial to recruit patient cohorts as representative as possible of the future target population. Missing these targets can lead to reduced validity of the study results, and can often slow down drug development leading to costly delays. This study explores the key factors related to perceptions and participation in vaccination trials. Methods: This study involved an anonymous cross-sectional online survey circulated across the UK. Statistical analysis was done in six phases. Multi-nominal logistic models examined demographic and geographic factors that may impact vaccine uptake. Results: The survey had 4884 participants of which 9·44% were BAME (Black Asian Minority Ethnic). Overall 2020 (41.4%) respondents were interested in participating in vaccine trials; 27.6% of the respondents were not interested and 31.1.% were unsure. The most interested groups were male (OR=1.290), graduates (OR=1.277), the 40-49 and 50-59 age group (OR=1.880 and OR=1.460 respectively) and those with no health issues (OR=1.064). The least interested groups were BAME (OR=0.427), those from villages and small towns (OR=0.66 and 0.54 respectively), and those aged 70 and above (OR=1.11).Conclusions: In order to have a vaccination that is generalizable to the entire population, greater work needs to be done in engaging a diverse cohort of participants. Public health campaigns need to be targeted in improving trial recruitment rates for the elderly, BAME community and the less educated rural population.


2020 ◽  
Author(s):  
Raylene Paludneviciene ◽  
Tracy Knight ◽  
Gideon Firl ◽  
Kaela Luttrell ◽  
Kota Takayama ◽  
...  

BACKGROUND During the COVID-19 pandemic, there has been a rapid increase in the amount of information about the coronavirus on the Internet. If the language used in the video message is not clear or understandable to deaf and hard of hearing (DHH) people with a high school degree or less, they can create confusion and information gaps among DHH people during a health emergency. OBJECTIVE To gather a baseline of DHH people’s perceptions related to effectiveness of physical distancing (PD) and asymptomatic individuals. METHODS A cross-sectional study of COVID-19 (N=445). Items included questions pertaining to COVID-19 knowledge were administered to US deaf adults from April 17, 2020, to May 1, 2020 via a bilingual ASL/English online survey platform. RESULTS The sample consisted of 445 DHH adults aged 18 to 88 years old, with 74% identifying as White and 54% as female. About 88% of the sample felt they knew most or a lot about PD. This figure dropped to 73% for the effectiveness of PD in reducing the spread of coronavirus and 72% for the contagiousness of an infected person without symptoms. PD awareness along with education were significant predictors of PD effectiveness (adj OR for PD awareness=5.00; 95% CI: 2.09, 11.95; adj OR for education=1.89; 95% CI: 1.13, 3.16). In a separate model, education and PD effectiveness significantly predicted knowledge of asymptomatic individual. Race, gender, and age did not contribute to both models for PD effectiveness and knowledge of asymptomatic individual. CONCLUSIONS This study results point to the strong connection between education and coronavirus-related knowledge. Therefore, the information that DHH organizations and public health agencies quickly disseminate information during emergencies and pandemics must be clear, contain adequate and reliable information, and are timely in concordance with other information being disseminated.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Pınar Göbel ◽  
Nevin Şanlier ◽  
Sine Yilmaz ◽  
Onur Toka ◽  
Büşra Açikalin ◽  
...  

Purpose The purpose of this paper is to evaluate the levels of food safety knowledge, attitudes and practices (KAP) of consumer. Design/methodology/approach In total, 1,161 volunteers were included in this study, which has been developed to measure the knowledge, attitudes and behaviors of adults on food safety. Study data were collected through an online survey technique. Findings A statistically significant difference was determined between male and female participants and also at the education level considering total food safety attitude and practice scores (p < 0,001). It was determined that university graduates had higher scores at all scales than the median scores. When an assessment was made on the body mass index of the participants, it was seen that the implementation and attitude scales were statistically different from each other, and in paired comparisons on these scales, the average scores of normal-weight individuals were observed higher in the sub-dimensions than slightly obese individuals (p < 0.007; p < 0.001). Research limitations/implications Even though the population of the study was adults living in different cities, the results should not be generalized to all adults and the whole country. Also, the fact that the answers to the questions were not face-to-face, could create a bias. Although the reliability coefficient was found to be high, the data reported by the individuals participating in the study about their behavior formed the study results. Originality/value This study makes an important contribution to the literature. Determining the knowledge, attitude and behavior of consumers about food safety is important in ensuring food safety.


2021 ◽  
Vol 11 (Suppl. 1) ◽  
pp. 74-80
Author(s):  
Ersin Yıldırım ◽  
Artemisa Adıgüzel ◽  
Şeniz Karaçay

Aim: This study aims to determine the anxiety levels of orthodontic patients related to the coronavirus pandemic and to evaluate the effects of quarantine on orthodontic appointments and orthodontic treatment. Methodology: This cross-sectional study was conducted as an online survey with the participation of patients who were actively receiving orthodontic treatment. A total of 281 orthodontic patients (191 [67.97%] females and 90 [32.03%] males) participated in the survey. The questionnaire consisted of five sections that included questions about demographics, the COVID-19 pandemic, and the patients’ orthodontic status. Anxiety levels were measured using Turkish versions of the Beck Anxiety Inventory and the Corah’s Dental Anxiety Scale. Descriptive statistics, the Kolmogorov-Smirnov and Shapiro-Wilk normality tests, the Pearson correlation test, and the Mann Whitney U test were used for statistical analysis. Results: Regarding patients’ perceptions of the pandemic, 251 patients (89.32%) reported that they were sufficiently informed about COVID-19. The main concern about the effects of quarantine on orthodontic treatment was the delay of orthodontic treatment at a rate of 58.36% (164/281). This study found that 36% (103/281) of the participants exhibited anxiety symptoms. The prevalence of dental anxiety specifically was 33% (95/281). Our study results reveal a significant relationship between dental anxiety and general anxiety, which indicates that dentally anxious people tend to also be generally anxious. Females had significantly higher anxiety levels than males (p <0.001). Conclusion: The coronavirus pandemic and quarantine seem to impact orthodontic patients’ anxiety. Delay of treatment was the primary concern of patients during the COVID-19 pandemic. Female patients were more anxious than males.   How to cite this article: Yıldırım E, Adıgüzel A, Karaçay Ş. Assessment of the anxiety levels of orthodontic patients during the COVID-19 pandemic. Int Dent Res 2021;11(Suppl.1):73-9. https://doi.org/10.5577/intdentres.2021.vol11.suppl1.12   Linguistic Revision: The English in this manuscript has been checked by at least two professional editors, both native speakers of English.  


2021 ◽  
Vol 8 (3) ◽  
pp. 195-199
Author(s):  
Vaseemunnisa Begum ◽  
Neeraj Sadiq ◽  
Ghulam Subhani ◽  
Asma Gulnaaz ◽  
Mohammed Mohsin ◽  
...  

: The Global disease (COVID-19 pandemic) has impacted our lives in various ways. Online teaching is the strange routine for studying platforms to continue with the process of educating students, Online classes have become a key component in the continuity of education.: 1. This study aims to rank the usefulness of online teaching compared to classroom conventional teaching 2. Socioeconomic parameters related to online teaching in a medical college: The study is a cross-sectional study done on medical students. A questionnaire was prepared listing the various ways in which they discern online teaching trying to cope up during the pandemic.: After the institutional Ethics committee clearance, online cross-sectional study was done on the medical students where from the 2 and 3 year. This online survey was done between 10May 2021- 10 June 2021, A total number of 211 students participated out of 250, after completion of 18 months of online classes. A Set of 15 self -designed questionnaire based on 5 point Likert scale was given to the students to rank the effectiveness through online class usefulness levels and satisfaction levels on various parameters. Students were also asked about the demographic factors. The data was analyzed using software SPSS software The study results shows that online classes is less helpful in five parameters and equally helpful in five parameters but was not at all superior to conventional methods, we can come to the interpretation that students think that classroom teaching cannot be replaced by online teaching. We can conclude that online studies can only be a supplement and cannot be an alternate for the established order of learning


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