Development and Validity of Questionnaire for Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study

Author(s):  
Sharad Desai ◽  
Nilesh Patel

Participation of humans in clinical research is always remained questionable. Hence evaluation of such doubt helps to conclude the perception about such participation. This research presents the process for development and validation of questionnaire for Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study. For development of questionnaire, literature search, experts’ discussion and authors’ experience was used for domain identification and its segregation for different variables. For validity of questionnaire, face validity and content validity was performed. Modification was done based on response from experts during non-quantitative face validity. % of overall agreement was 94.55 for question asked in face validity. While, Content Validity Ratio and Content Validity Index was calculated using the process mentioned by Lawshe and Lynn respectively. Initially 83 items were identified but based on validation 84 items were finalized after removal of three and addition of four questions. Deleted three items had Content Validity Ratio of 0.00, 0.67 and 0.67 and which were below accepted level of 0.99. While, I-CVI was observed from range of 0.83 to 1.00 and S-CVI values were above acceptable level of 0.90 for S-CVI (S-CVI/ Ave) and 0.80 for S-CVI (S-CVI/UA) for whole questionnaire and each part.

Author(s):  
Sharad Desai ◽  
Nilesh Patel

This paper presents the results of Demographic and Participation Details of Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study. For that data of 50 participants was collected using self-administered questionnaire. After ethics approval, data were collected between between Jul-21 and Aug-21 from Gujarat state of India. Results of demographic and participation details are tabulated by its frequency and percentage. Participants are participating more whose age range were 18-41 years, income less than one lakh, education below Higher Secondary and having private job or wage-earner. Age of first time participation was found in range of 18-41 years and frequency of number studies in which participant participated were found from 01 to 20 studies. Also Chi-Square results suggested there is significant (p < 0.05) relation (I) between the Education and Age of first time participation (II) between the occupation and number of times participated.


2021 ◽  
pp. JNM-D-20-00085
Author(s):  
Mohammad H. Abuadas ◽  
Zainab F. Albikawi ◽  
Foud Abuadas

BackgroundConsideration needs to be given to a variety of factors that influence the implementation of evidence-based nursing practice (EBNP).AimThis study aimed to develop and validate a questionnaire that measures registered nurses' competencies, beliefs, facilitators, barriers, and implementation of EBNP.MethodsMethodological cross-sectional study in which 612 registered nurses were selected by convenient sampling. A panel of six experts evaluated the content validity of the first draft of the EBPCBFRI questionnaire. The final questionnaire was made up of 55 items. Reliability was determined by means of internal consistency. Construct, convergent, discriminant, and predictive validity was assessed.ResultsThe questionnaire has proven acceptable reliability and validity when used with registered nurses. The scale-level content validity index was .92. Cronbach's α coefficient for the total questionnaire was .87. Exploratory factor analysis supported five significant factors that explained 64.8% of the variance.


2020 ◽  
Author(s):  
Vijaya Raj Bhatt ◽  
Prajwal Dhakal ◽  
Christopher S Wichman ◽  
Bunny Pozehl

We incorporated questions related to safety, effectiveness and other characteristics of systemic cancer treatment into a self-report questionnaire – the Therapy Preference Scale – that captures patients´ preferences. The authors asked 20 experts to assess content validity and an additional 20 experts, patients and community members to examine face validity and guide revisions. Key revisions included shortening the length, clarifying constructs and providing details to explain the context and trade-offs necessary to balance the risks and benefits of cancer treatment. The content validity index for the final questionnaire was 1.0, indicating that all questions were relevant. Reviewers expressed that the questionnaire would serve an important purpose. Experts, patients and community members guided revisions of the questionnaire and documented its value.


Author(s):  
Juliano Flávio Rubatino Rodrigues ◽  
Spencer Payão ◽  
Hannes Fischer

Objective: Our goal is to develop an online questionnaire to survey the prevalence of suicidal behavior. Methods: We developed a questionnaire with 51 variables and proceeded with validations. Validations were performed using face validity, content validity, and construct validity. Reliability was performed by test-rest. Results: The face validity was 1.0 and the content validity was 0.91. The exploratory factor analysis got KMO = 0.86 and extracted one principal factor. The confirmatory factor analysis demonstrates RMSEA= 0.000 and CFI=1.000. The test-retest had an intraclass correlated coefficient of 0.98. Conclusion: The adequate development questionnaire was validated, and we have an instrument to survey suicide behaviors in the pandemic time.


2021 ◽  
pp. 003329412110360
Author(s):  
Abbas Abdollahi ◽  
Kelly A. Allen

Romantic perfectionismi can be disruptive to relationships, yet no validated measure for assessing romantic perfectionism in Iranian couples has been developed. Therefore, the purpose of this study was to translate and validate the Romantic Perfectionism Scale (RPS) among Iranian couples. Participants in the study were 200 married men and 320 married women from Tehran, Iran, who completed the translated RPS, the Almost Perfect Scale-Revised, and the Depression Anxiety Stress Scale-21 online. Item impact scores were used to calculate face validity. Impact score values for all items were greater than 1.5, signaling appropriate face validity.. The Content Validity Index (CVI) and the Content Validity Ratio (CVR) were used to measure content validity. Values of the CVI were above the cut-off score of 0.7, implying satisfactory content validity of the items. The CVR values were greater than the Lawshe table (0.78) cut-off score, demonstrating that all items were essential. Confirmatory Factor Analysis (CFA) using AMOS software was used to evaluate the construct validity. The results of the goodness of fit indices confirmed the RPS with two subscales (i.e., self-oriented romantic perfectionism and other-oriented romantic perfectionism) as per the original scale. All items remained in the scale as all factor loading values were greater than 0.45. The findings showed that the two subscales, and the scale as a whole, had acceptable internal consistency, as the construct reliability values for self-oriented romantic perfectionism (0.81), other-oriented romantic perfectionism (0.72), and the whole scale (0.74) were greater than 0.7. The results support the psychometric properties of the Iranian version of the RPS, which could be used by future researchers and clinicians to assess romantic perfectionism in Iranian couples.


Author(s):  
Hyeona So ◽  
Dahyun Park ◽  
Mi-Kyung Choi ◽  
Young-Sun Kim ◽  
Min-Jeong Shin ◽  
...  

Food literacy refers to the knowledge, skills, and attitudes required for individuals to choose foods that promote health. As the rate of diet-related diseases increases, food literacy is becoming more important. However, there are no tools available to evaluate food literacy among the Korean elderly. We derived 547 questions from a literature review and, after three rounds of Delphi surveys, selected 33 preliminary questions. We calculated the content validity ratio of the questions and applied a face validity procedure. We then selected 32 questions, assessed their validity, and distributed them as a questionnaire to 205 elderly people. We then conducted exploratory factor analysis (EFA) to determine the validity of the questionnaire and used an internal consistency index (Cronbach’s α coefficient) to determine reliability. Based on the factor analysis, 13 questions were selected, distributed among three factors, and evaluated using the Kaiser–Meyer–Olkin (KMO) and Bartlett sphericity tests. The factor analysis showed that KMO was 0.872, which is a highly acceptable score, and the Bartlett sphericity test was χ2 = 1,374.69 at p = 0.00. The food literacy questionnaire developed in this study will likely be helpful for improving the healthcare of elderly people.


Author(s):  
Gianluca Sambataro ◽  
Domenico Sambataro ◽  
Martina Orlandi ◽  
Sofia Battisti ◽  
Lorenzo Cavagna ◽  
...  

Abstract Objectives Quantitative computed tomography (QCT) is a promising tool for objective assessment of interstitial lung disease (ILD) related to connective tissue diseases (CTD). However, its validity was never investigated. The aim of this study was to assess QCT feasibility, face, and content validity evaluation concerning CTD-ILD. Methods A rheumatologist and a chest radiologist conceived an online survey with nine statements: Two about general issue involving CTD-ILD, one for the face validity, three both for content validity and feasibility. Each statement had to be rated with a score from 0 to 100, respectively, (complete disagreement and agreement). We considered a statement supported by the experts if the median score was ≥75.0. Results A panel of 14 experts (11 from Europe, three from America) with a nine years median experience was enrolled. All the statements about feasibility, face and content validity were supported, except for QCT capability to recognize elementary lesions. Conclusions The panel of experts supported feasibility, face, and content validity of QCT assessment concerning CTD-ILD. This may stimulate a greater use in clinical practice and further studies to confirm its discriminative properties and its construct validity.


2018 ◽  
Vol 37 (1) ◽  
pp. 64-73
Author(s):  
Soubhagyalaxmi Mohanty ◽  
Sasipriya Venkataramanujam ◽  
Balaram Pradhan ◽  
Alex Hankey

Yoga has been found to be an effective intervention in children with visual impairment. Yoga modules used in previous studies were based on individual researcher’s experience. However, no mention was given of them being endorsed by other specialists in the field. This study aimed to develop, validate, and assess the feasibility of a yoga module exclusively for children with visual impairment. A yoga module was developed based on traditional and contemporary yoga literature and published studies with the objectives of determining needs of the participants and yoga practices that could prove efficient. Its validation was carried out with 25 experts over two rounds of iteration and feasibility of the practices evaluated on nine children with visual impairment. Tennis ball throw and standing vertical jump tests were done to evaluate success of yoga practice. A total of 30 yoga practices with content validity ratio ⩾ 0.37 were retained in the final yoga module. All experts opined that the final module is technically easy to teach, learn, and practice. All the children reported 80% of satisfaction level with the yoga practices and the procedure used to teach them at the end of the intervention. The score in tennis ball throw increased significantly ( p = .011) after the intervention, but the standing vertical jump score ( p = .585) did not. Positive exit survey responses and good participation rates support the module’s feasibility. Based on evidence from the traditional knowledge and scientific studies, the yoga module was validated for the children with visual impairment. The feasibility of the module was also assessed successfully which can be used safely and effectively as an alternative training for individuals with visual impairment.


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