Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent

singh, Addanki Purna; Vadakedath, Sabitha; Kandi, Venkataramana

doi:10.7759/cureus.33374

Cited by 8 publications

(4 citation statements)

References 34 publications

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“…To arrive at a confidence interval of 95%, the sample size was calculated using Cochran’s formula, in accordance with Bartlett et al ( 16 ). The sampling strategy employed to recruit and distribute participants into dental professional groups was non-probability voluntary response sampling ( 17 ).…”

Section: Methodsmentioning

confidence: 99%

Dentists and dental hygienists’ comprehension of HIV infection associated periodontal implications and management

Ahmed

2024

Front. Public Health

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BackgroundIn an era wherein, persuasive evidence continues to witness the association between systemic and periodontal diseases, the absence of scientific data on dental professionals’ comprehension concerning the HIV infection and periodontal link is lamentably backward. Thus, the key objective of this research is to ascertain the extent of comprehension possessed by dentists and dental hygienists concerning periodontal implications and their management in HIV patients.MethodsIt is a quantitative cross-sectional survey employing a descriptive approach focusing on a specific cohort of dental professionals. The study setting featured an online platform for the distribution of concealed, closed-ended, structured questionnaire. The data was gathered for four sections: six comprehension statements about periodontal manifestations in HIV patients; fifteen comprehension statements about HIV patients’ periodontal management; eight familiarity statements about HIV management; and two educational statements about HIV. The comparisons of comprehension scores were drawn between variables such as specialties, age groups, and genders.ResultsThe survey represented 468 dental professionals representing distinct dental specialties, with a mean age of 24.26 ± 7.53 years. The mean comprehension score for all groups of participants is 10.31 ± 9.34 (33.25%). The highest scores were recorded among those aged 31–40 (20.67 ± 8.31), followed by those aged 40+ (19.38 ± 9.39), 20–30 (9.53 ± 8.96), and under 20 (8.92 ± 8.57), at p < 0.001. The female participants (15.06 ± 12.2) exhibited substantially better scores in contrast to the male participants (8.74 ± 7.57). Periodontists (27.77 ± 3.08) comprehended most, then the oral medicine practitioners (25 ± 0). Dental hygiene students (5.52 ± 3.56) and hygienists (7.67 ± 9.72) comprehended the least. The scores for all four domains assessed were disappointingly low: knowledge about HIV-periodontal manifestations (2.81 ± 2.18), knowledge about management of periodontal diseases in HIV patients (3.73 ± 4.7), familiarity with periodontal care in HIV patients (2.87 ± 3.01), and education received about HIV and periodontal diseases (0.91 ± 0.66).ConclusionDental professionals are notably incomprehensive, unfamiliar, and lacking in expertise in the realm of periodontal facets of HIV. The periodontists and oral medicine practitioners showed a substantial amount of comprehension, while the dental hygiene students and dental hygienists presented a conspicuously inadequate level of comprehension. The study outcome could potentially serve as an invaluable instrument for self-assessment by dental professionals and educators. HIV/AIDS ought not to persist as an unspoken taboo or disregarded subject within the dental field, particularly in periodontics, but rather should receive prominence in dental schools and professional development programs.

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Section: Methodsmentioning

confidence: 99%

Dentists and dental hygienists’ comprehension of HIV infection associated periodontal implications and management

Ahmed

2024

Front. Public Health

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“…Informed by our iKT process, a range of recruitment videos (tailored for gender) were also created in addition to written material, which will be released via Twitter and Facebook. A non-probability sampling technique (voluntary response sampling) 53 will be used, and recruitment will continue until the desired number of participants is achieved. Recruitment commenced in August 2021 and was completed in April 2022.…”

Section: Recruitmentmentioning

confidence: 99%

Examining the efficacy of a telehealth intervention targeting addictive eating in Australian adults (the TRACE Programme): a randomised controlled trial protocol

et al. 2023

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IntroductionApproximately 15%–20% of the adult population self-report symptoms of addictive eating. There are currently limited options for management. Motivational interviewing-based interventions, containing personalised coping skills training, have been found to be effective for behaviour change in addictive disorders (eg, alcohol). This project builds upon foundations of an addictive eating feasibility study previously conducted and co-design process involving consumers. The primary aim of this study is to examine the efficacy of a telehealth intervention targeting addictive eating symptoms in Australian adults compared with passive intervention and control groups.Methods and analysisThis three-arm randomised controlled trial will recruit participants 18–85 years, endorsing ≥3 symptoms on the Yale Food Addiction Scale (YFAS) 2.0, with body mass index >18.5 kg/m2. Addictive eating symptoms are assessed at baseline (pre-intervention), 3 months (post-intervention) and 6 months. Other outcomes include dietary intake and quality, depression, anxiety, stress, quality of life, physical activity and sleep hygiene. Using a multicomponent clinician-led approach, the active intervention consists of five telehealth sessions (15–45 min each) delivered by a dietitian over 3 months. The intervention uses personalised feedback, skill-building exercises, reflective activities and goal setting. Participants are provided with a workbook and website access. The passive intervention group receives the intervention via a self-guided approach with access to the workbook and website (no telehealth). The control group receives personalised written dietary feedback at baseline and participants advised to follow their usual dietary pattern for 6 months. The control group will be offered the passive intervention after 6 months. The primary endpoint is YFAS symptom scores at 3 months. A cost–consequence analysis will determine intervention costs alongside mean change outcomes.Ethics and disseminationHuman Research Ethics Committee of University of Newcastle, Australia provided approval (H-2021-0100). Findings will be disseminated via publication in peer-reviewed journals, conference presentations, community presentations and student theses.Trial registration numberAustralia New Zealand Clinical Trials Registry (ACTRN12621001079831).

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“…Experimental studies are of two types that include observational (cross-sectional studies (surveys), casecontrol studies, and cohort studies) and experimental studies (randomized control studies) [3,31]. Such research may pose challenges related to ethics in relation to the social and cultural milieu.…”

Section: Clinical Trials: Epidemiological and Human Genetics Studymentioning

confidence: 99%

Clinical Trials and Clinical Research: A Comprehensive Review

Kandi¹,

Vadakedath²

2023

Cureus

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Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

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Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent

Cited by 8 publications

References 34 publications

Dentists and dental hygienists’ comprehension of HIV infection associated periodontal implications and management

Dentists and dental hygienists’ comprehension of HIV infection associated periodontal implications and management

Examining the efficacy of a telehealth intervention targeting addictive eating in Australian adults (the TRACE Programme): a randomised controlled trial protocol

Clinical Trials and Clinical Research: A Comprehensive Review

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