BackgroundThe use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.MethodsThis multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).ResultsOf the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).ConclusionsResearch participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.Electronic supplementary materialThe online version of this article (10.1186/s12910-018-0318-x) contains supplementary material, which is available to authorized users.
Background COVID-19 has inundated the entire world disrupting the lives of millions of people. The pandemic has stressed the healthcare system of India impacting the psychological status and functioning of health care workers. The aim of this study is to determine the burnout levels and factors associated with the risk of psychological distress among healthcare workers (HCW) engaged in the management of COVID 19 in India. Methods A cross-sectional study was conducted from 1 September 2020 to 30 November 2020 by telephonic interviews using a web-based Google form. Health facilities and community centres from 12 cities located in 10 states were selected for data collection. Data on socio-demographic and occupation-related variables like age, sex, type of family, income, type of occupation, hours of work and income were obtained was obtained from 967 participants, including doctors, nurses, ambulance drivers, emergency response teams, lab personnel, and others directly involved in COVID 19 patient care. Levels of psychological distress was assessed by the General health Questionnaire -GHQ-5 and levels of burnout was assessed using the ICMR-NIOH Burnout questionnaire. Multivariable logistic regression analysis was performed to identify factors associated with the risk of psychological distress. The third quartile values of the three subscales of burnout viz EE, DP and PA were used to identify burnout profiles of the healthcare workers. Results Overall, 52.9% of the participants had the risk of psychological distress that needed further evaluation. Risk of psychological distress was significantly associated with longer hours of work (≥ 8 hours a day) (AOR = 2.38, 95% CI(1.66–3.41), income≥20000(AOR = 1.74, 95% CI, (1.16–2.6); screening of COVID-19 patients (AOR = 1.63 95% CI (1.09–2.46), contact tracing (AOR = 2.05, 95% CI (1.1–3.81), High Emotional exhaustion score (EE ≥16) (AOR = 4.41 95% CI (3.14–6.28) and High Depersonalisation score (DP≥7) (AOR = 1.79, 95% CI (1.28–2.51)). About 4.7% of the HCWs were overextended (EE>18); 6.5% were disengaged (DP>8) and 9.7% HCWs were showing signs of burnout (high on all three dimensions). Conclusion The study has identified key factors that could have been likely triggers for psychological distress among healthcare workers who were engaged in management of COVID cases in India. The study also demonstrates the use of GHQ-5 and ICMR-NIOH Burnout questionnaire as important tools to identify persons at risk of psychological distress and occurrence of burnout symptoms respectively. The findings provide useful guide to planning interventions to mitigate mental health problems among HCW in future epidemic/pandemic scenarios in the country.
Background:Access to reproductive health services in Human Immunodeficiency Virus (HIV) programs can greatly enhance program's potential to limit the spread of disease, reduce unintended pregnancies and safeguard the health of infected people.Objectives:To assess (i) knowledge, attitude, and use regarding contraceptives; safe sex and dual protection; (ii) fertility desires and unintended pregnancies post HIV and (iii) symptoms of reproductive tract infection/sexually transmitted infection (RTI/STI) among women infected with HIV.Materials and Methods:A cross-sectional study among 300 currently married HIV-positive women who had not undergone permanent sterilization with no immediate desire for pregnancy. Study site was Integrated Counseling and Testing Centers (ICTC) in tertiary hospitals of Mumbai and women were interviewed using a semistructured questionnaire.Results:In spite of good awareness about modern methods, 42.7 felt that contraceptives other than condoms were harmful to use due to their HIV status. Knowledge on dual protection was limited to condom (75%). Condom use increased from 5.7% pre-HIV to 71.7% post-HIV, with 89.6% reporting regular use. Future fertility desire was expressed by 8.7% women. Induced abortions post-HIV was reported by16.6% women, as pregnancies were unintended. About 69% wished to use dual contraceptive methods for effective protection if it was not harmful to be used by people living with HIV (PLHIV).Conclusion:Data reveals a need to promote modern contraceptive methods along with regular condom use to prevent unintended pregnancies and improve health-seeking behavior for contraception. Health system models that converge or link HIV services with other reproductive health services need to be tested to provide comprehensive reproductive healthcare to infected women in India.
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