The Growing Importance of Mixed-Methods Research in Health.

This paper illustrates the growing importance of mixed-methods research to many health disciplines ranging from nursing to epidemiology. Mixed-methods approaches requires not only the skills of the individual quantitative and qualitative methods but also a skill set to bring two methods/datasets/findings together in the most appropriate way. Health researchers need to pay careful attention to the 'best' approach to designing, implementing, analysing, integrating both quantitative (number) and qualitative (word) information and writing this up in a way offers greater insights and enhances its applicability. This paper highlights the strengths and weaknesses of mixed-methods approaches as well as some of the common mistakes made by researchers applying mixed-methods for the first time.

Development and implementation of a potential coronavirus disease 2019 (COVID-19) vaccine: A systematic review and meta-analysis of vaccine clinical trials.

BACKGROUND: To date, there is no comprehensive systematic review and meta-analysis to assess the suitability of COVID-19 vaccines for mass immunization. The current systematic review and meta-analysis was conducted to evaluate the safety and immunogenicity of novel COVID-19 vaccine candidates under clinical trial evaluation and present a contemporary update on the development and implementation of a potential vaccines. METHODS: For this study PubMed, MEDLINE, and Embase electronic databases were used to search for eligible studies on the interface between novel coronavirus and vaccine design until December 31, 2020. RESULTS: We have included fourteen non-randomized and randomized controlled phase I-III trials. Implementation of a universal vaccination program with proven safety and efficacy through robust clinical evaluation is the long-term goal for preventing COVID-19. The immunization program must be cost-effective for mass production and accessibility. Despite pioneering techniques for the fast-track development of the vaccine in the current global emergency, mass production and availability of an effective COVID-19 vaccine could take some more time. CONCLUSION: Our findings suggest a revisiting of the reported solicited and unsolicited systemic adverse events for COVID-19 candidate vaccines. Hence, it is alarming to judiciously expose thousands of participants to COVID-19 candidate vaccines at Phase-3 trials that have adverse events and insufficient evidence on safety and effectiveness that necessitates further justification.

Epidemiologic characteristics, clinical management, and public health implications of Coronavirus Disease 2019 (COVID-19) in pregnancy: A Systematic Review and Meta-analysis.

BACKGROUND: The novel Coronavirus Disease 2019 (COVID-19) outbreak, caused by the pathogenic severe acute respiratory syndrome-2 (SARS-CoV-2) virus, is exponentially spreading across the globe. METHODS: The current systematic review was performed utilising the following electronic databases PubMed, MEDLINE and EMBASE. We searched for the keywords "COVID-19 AND "pregnancy" between January 1, 2020 until December 31, 2020. RESULTS: Out of 4005 records which were identified, 36 original studies were included in this systematic review. Pooled prevalence of vertical transmission was 10%, 95% CI: 4-17%. Pooled prevalence of neonatal mortality was 7%, 95% CI: 0-21%. CONCLUSION: The contemporary evidence suggests that the incubation period of COVID-19 is 2-14 days, and this infection could be transmitted even from the infected asymptomatic individuals. It is found that the clinical presentation of pregnant women with COVID-19 infection is comparable with the infected non-pregnant females, and the frequent symptoms were fever, cough, myalgia, sore throat and malaise. Some cases have severe maternal morbidity and perinatal deaths secondary to COVID-19 infection. Under these circumstances, pregnant women should focus on maintaining personal hygiene, proper nutrition and extreme social distancing to reduce the risk of COVID-19. Therefore, systematic data reporting for evidence based clinical assessment, management and pregnancy outcomes is essential for preventing of COVID-19 infection among pregnant women.

Impact of COVID-19 on clinical trials and clinical research: A systematic review.

Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants' inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords "COVID-19" AND "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.

Cigarette smoking dose-response and suicidal ideation among young people in Nepal: a cross-sectional study.

BACKGROUND: Worldwide, tobacco smoking is a major risk factor for morbidity and early mortality among adult population. The present study aimed to find out the association between current smoking and suicidal ideation among young people in Nepal. MATERIALS AND METHODS: A cross-sectional questionnaire-based survey was carried out among 452 youths from Pokhara, Nepal. The present study included both genders (age 18-24 years) who were smokers as well as non-smokers. RESULTS: Across the study period, 452 participants were identified after matching for age, and sex (226 in the smoking group and 226 in the non-smoking group). The mean age of participants was 21.6±1.2 years and 58.8% were males. The overall rate of suicidal ideation in our cohort was 8.9%. Smokers were slightly more likely to report suicidal ideation than non-smokers (aOR 1.12). The risk of developing suicidal ideation was 3.56 (95% CI 1.26-10.09) times more in individuals who smoked greater than 3.5 cigarettes per week (p=0.01). CONCLUSION: The rate of suicidal ideation was slightly higher among smokers and a dose-response relationship was identified with the number of cigarettes smoked per week. Being aware of the link between smoking and suicidal ideation may help health care professionals working with young people to address more effectively the issues of mental well-being and thoughts about suicide.

Ethnic Variations in Perception of Human Papillomavirus and its Vaccination among Young Women in Nepal .

BACKGROUND: The Human Papillomavirus (HPV) is strongly associated with cervical and other cancers. In women, cervical cancer is the third most common cancer. HPV infection can be largely prevented through vaccination of (adolescent) girls. At the same time, Nepal is a low-income country experiencing a cultural change in attitudes towards sex and sexual behaviour. However, in the adolescent population knowledge about HPV, factors associated with an increased risk of HPV and the existence of the vaccination is often low. MATERIALS AND METHODS: This was a cross-sectional study with female students enrolled in health and non-health science courses in Pokhara, Nepal. The questionnaire included demographic details, knowledge and attitude questions related to HPV, associated risk behaviour and its vaccination. Descriptive statistics, including Chi-Square test, were used to identify statistically significant relationships. Ethical approval was granted by the relevant authority in Nepal. RESULTS: Hindu religion (75.0 %; 95% CI: 70.9, 78.6) and Newari caste (75.5%; CI: 61.1, 86.7) were more aware about HPV, HPV vaccination. Hindus religion (55.6%; 95% CI: 51.2, 60.0) and Dalit caste (61.6%, 95% CI: 53.3, 69.4) more willing to be vaccinated than other religions and other castes, respectively. Not unsurprisingly, students on health-related courses had a greater awareness of HPV, HPV vaccination and were more willing to be vaccinated than students on other courses. Similar patterns of association arose for knowledge related to those sexually active at an early age; HPV risk and multiple sex partners; and fact that condoms cannot fully prevent the transmission of HPV. CONCLUSION: Knowledge about the link between HPV and (a) early sexual initiation, (b) having multiple sexual partners, and (c) the limited protection of condoms and other birth control measures was poor in our study compared to similar research conducted in other parts of the world. One key implication is the need for education campaigns in Nepal to educate young women and their parents about HPV, its risk factors and the benefits of vaccination. .

Factors Influencing Sexual Behaviour Between Tourists and Tourism Employees: A Systematic Review.

BACKGROUND: Increased travel abroad has a significant impact on the incidence and prevalence of Sexually Transmitted Infections (STIs). Previous reviews have focused on the knowledge, attitudes and behaviour of tourists and acquisition of STIs. Less is known about the impact on tourism operators in countries visited by tourists. The aim of this review is to ascertain factors influencing sexual behaviour between workers in the tourism industry and tourists; exploring the prevalence of sexual behaviour between the two populations, their perceptions of sexual risk while engaging in sexual activities and the knowledge of tourism operators regarding STIs. METHODS: A systematic review was conducted. Database searches were performed in Medline/Ovid, EMBASE, Cochrane library and CINAHL for studies published between 2000 and March 2016. Grey literature searches were completed in the NHS database and Google Scholar between 2000 and December 2013. Papers were independently selected by two researchers. Data were extracted and critically appraised using a pre-designed extraction form and adapted CASP checklist. RESULTS: The search identified 1,602 studies and 16 were included after review of the full text. Studies were conducted in nine countries. Findings suggest that STI knowledge, attitude and practice were fairly good among tourists and tourism workers, but there is a need for pre-travel advice for travellers, especially those travelling to low and middle-income countries. Greater importance was given to tourists than to tourism operators and locals interacting with tourists. Studies suggest that as a group both tourist and tourist workers were likely to engage in sexual activities. Overall, both condom use and STI screening were low, among tourists as well as tourism operators. Furthermore, studies reported links between drug and alcohol use and sexual behaviour and risk taking. CONCLUSION: Although less research appeared to have been conducted among tourism workers than tourists, it does demonstrate the need for education, training and promotion of travel medicine. STI screening, pre-travel advice, travel history in terms of contracting STIs and safe-sex awareness-raising are needed. More and better sexual health education and relevant tourism policies are needed globally.

Patient choice for older people in english NHS primary care: theory and practice.

In the English National Health Service (NHS), patients are now expected to choose the time and place of treatment and even choose the actual treatment. However, the theory on which patient choice is based and the implementation of patient choice are controversial. There is evidence to indicate that attitudes and abilities to make choices are relatively sophisticated and not as straightforward as policy developments suggest. In addition, and surprisingly, there is little research on whether making individual choices about care is regarded as a priority by the largest NHS patient group and the single largest group for most GPs-older people. This conceptual paper examines the theory of patient choice concerning accessing and engaging with healthcare provision and reviews existing evidence on older people and patient choice in primary care.

Women's knowledge of and attitude towards disability in rural Nepal.

PURPOSE: What is perceived to be a disability is both culturally specific and related to levels of development and modernity. This paper explores knowledge and attitudes towards people with disabilities among rural women in Nepal, one of the poorer countries in South Asia. METHOD: Four hundred and twelve married women of reproductive age (aged 15-49 years), from four villages in two different parts of Nepal, who had delivered a child within the last 24 months preceding the study, completed a standard questionnaire. RESULTS: The majority of the participants only considered physical conditions that limit function of an individual and are visible to naked eyes, such as missing a leg or arm, to be disability. Attitudes towards people with disability were generally positive, for example most women believed that disabled people should have equal rights and should be allowed to sit on committees or get married. Most respondents thought that disability could result from: (i) accidents; (ii) medical conditions; or (iii) genetic inheritance. Fewer women thought that disability was caused by fate or bad spirits. CONCLUSIONS: There is need to educate the general population on disability, especially the invisible disabilities. There is also a need for further research on disability and its social impact. IMPLICATIONS FOR REHABILITATION: • There is need to educate the general population on disability, especially the invisible disabilities and its rehabilitation. There is also a need for further research on disability and its social impact.

Ethical approval in developing countries is not optional.

When conducting health and medical research it is important to do the research ethically and to apply for prior ethical approval from the relevant authorities. The latter requirement is true for developed countries as well as developing countries. The authors argue that simply applying for research ethics approval from an institutional review board at a university based in a developed country is not enough to start a health research project in a developing country. The paper also suggests a number of reasons why researchers may fail to seek local research ethics permission in developing countries. The authors use a recent paper reporting research conducted in Nepal and published in an international journal as a case study to highlight the importance of being sensitive to local requirements regarding applying for and registering health and medical research.

Reasons for non- use of condoms and self- efficacy among female sex workers: a qualitative study in Nepal.

BACKGROUND: Heterosexual contact is the most common mode of transmission of sexually transmitted infections (STIs) including Human Immunodeficiency Virus (HIV) in Nepal and it is largely linked to sex work. We assessed the non-use of condoms in sex work with intimate sex partners by female sex workers (FSWs) and the associated self-efficacy to inform the planning of STI/HIV prevention programmes in the general population. METHODS: This paper is based on a qualitative study of Female Sex Workers (FSWs) in Nepal. In-depth interviews and extended field observation were conducted with 15 FSWs in order to explore issues of safe sex and risk management in relation to their work place, health and individual behaviours. RESULTS: The main risk factor identified for the non-use of condoms with intimate partners and regular clients was low self efficacy. Non-use of condoms with husband and boyfriends placed them at risk of STIs including HIV. In addition to intimidation and violence from the police, clients and intimate partners, clients' resistance and lack of negotiation capacity were identified as barriers in using condoms by the FSWs. CONCLUSION: This study sheds light on the live and work of FSWs in Nepal. This information is relevant for both the Government of Nepal and Non Governmental Organisations (NGO) to help improve the position of FSWs in the community, their general well-being and to reduce their risks at work.

Utilisation of sexual health services by female sex workers in Nepal.

BACKGROUND: The Nepal Demographic Health Survey (NDHS) in 2006 showed that more than half (56%) of the women with sexually transmitted infections (STIs), including HIV, in Nepal sought sexual health services. There is no such data for female sex workers (FSWs) and the limited studies on this group suggest they do not even use routine health services. This study explores FSWs use of sexual health services and the factors associated with their use and non-use of services. METHODS: This study aimed to explore the factors associated with utilisation of sexual health services by FSWs in the Kathmandu Valley of Nepal, and it used a mixed-method approach consisting of an interviewer administered questionnaire-based survey and in-depth interviews. RESULTS: The questionnaire survey, completed with 425 FSWs, showed that 90% FSWs self-reported sickness, and (30.8%) reported symptoms of STIs. A quarter (25%) of those reporting STIs had never visited any health facilities especially for sexual health services preferring to use non-governmental clinics (72%), private clinics (50%), hospital (27%) and health centres (13%). Multiple regression analysis showed that separated, married and street- based FSWs were more likely to seek health services from the clinics or hospitals. In- depth interviews with 15 FSWs revealed that FSWs perceived that personal, structural and socio-cultural barriers, such as inappropriate clinic opening hours, discrimination, the judgemental attitude of the service providers, lack of confidentiality, fear of public exposure, and higher fees for the services as barriers to their access and utilisation of sexual health services. CONCLUSION: FSWs have limited access to information and to health services, and operate under personal, structural and socio-cultural constraints. The 'education' to change individual behaviour, health worker and community perceptions, as well as the training of the health workers, is necessary.

Understanding effects of armed conflict on health outcomes: the case of Nepal.

OBJECTIVE: There is abundance of literature on adverse effects of conflict on the health of the population. In contrast to this, sporadic data in Nepal claim improvements in most of the health indicators during the decade-long armed conflict (1996-2006). However, systematic information to support or reject this claim is scant. This study reviews Nepal's key health indicators before and after the violent conflict and explores the possible factors facilitating the progress. METHODS: A secondary analysis has been conducted of two demographic health surveys-Nepal Family Health Survey (NFHS) 1996 and Nepal Demographic and Health Survey (NDHS) 2006; the latter was supplemented by a study carried out by the Nepal Health Research Council in 2006. RESULTS: The data show Nepal has made progress in 16 out of 19 health indicators which are part of the Millennium Development Goals whilst three indicators have remained static. Our analysis suggests a number of conflict and non-conflict factors which may have led to this success. CONCLUSION: The lessons learnt from Nepal could be replicable elsewhere in conflict and post-conflict environments. A nationwide large-scale empirical study is needed to further assess the determinants of Nepal's success in the health sector at a time the country experienced a decade of armed conflict.

Women's autonomy in household decision-making: a demographic study in Nepal.

BACKGROUND: How socio-demographic factors influence women's autonomy in decision making on health care including purchasing goods and visiting family and relatives are very poorly studied in Nepal. This study aims to explore the links between women's household position and their autonomy in decision making. METHODS: We used Nepal Demographic Health Survey (NDHS) 2006, which provided data on ever married women aged 15-49 years (n = 8257). The data consists of women's four types of household decision making; own health care, making major household purchases, making purchase for daily household needs and visits to her family or relatives. A number of socio-demographic variables were used in multivariable logistic regression to examine the relationship of these variables to all four types of decision making. RESULTS: Women's autonomy in decision making is positively associated with their age, employment and number of living children. Women from rural area and Terai region have less autonomy in decision making in all four types of outcome measure. There is a mixed variation in women's autonomy in the development region across all outcome measures. Western women are more likely to make decision in own health care (1.2-1.6), while they are less likely to purchase daily household needs (0.6-0.9). Women's increased education is positively associated with autonomy in own health care decision making (p < 0.01), however their more schooling (SLC and above) shows non-significance with other outcome measures. Interestingly, rich women are less likely to have autonomy to make decision in own healthcare. CONCLUSIONS: Women from rural area and Terai region needs specific empowerment programme to enable them to be more autonomous in the household decision making. Women's autonomy by education, wealth quintile and development region needs a further social science investigation to observe the variations within each stratum. A more comprehensive strategy can enable women to access community resources, to challenge traditional norms and to access economic resources. This will lead the women to be more autonomous in decision making in the due course.

The role of mothers-in-law in antenatal care decision-making in Nepal: a qualitative study.

BACKGROUND: Antenatal care (ANC) has been recognised as a way to improve health outcomes for pregnant women and their babies. However, only 29% of pregnant women receive the recommended four antenatal visits in Nepal but reasons for such low utilisation are poorly understood. As in many countries of South Asia, mothers-in-law play a crucial role in the decisions around accessing health care facilities and providers. This paper aims to explore the mother-in-law's role in (a) her daughter-in-law's ANC uptake; and (b) the decision-making process about using ANC services in Nepal. METHODS: In-depth interviews were conducted with 30 purposively selected antenatal or postnatal mothers (half users, half non-users of ANC), 10 husbands and 10 mothers-in-law in two different (urban and rural) communities. RESULTS: Our findings suggest that mothers-in-law sometime have a positive influence, for example when encouraging women to seek ANC, but more often it is negative. Like many rural women of their generation, all mothers-in-law in this study were illiterate and most had not used ANC themselves. The main factors leading mothers-in-law not to support/encourage ANC check ups were expectations regarding pregnant women fulfilling their household duties, perceptions that ANC was not beneficial based largely on their own past experiences, the scarcity of resources under their control and power relations between mothers-in-law and daughters-in-law. Individual knowledge and social class of the mothers-in-law of users and non-users differed significantly, which is likely to have had an effect on their perceptions of the benefits of ANC. CONCLUSION: Mothers-in-law have a strong influence on the uptake of ANC in Nepal. Understanding their role is important if we are to design and target effective community-based health promotion interventions. Health promotion and educational interventions to improve the use of ANC should target women, husbands and family members, particularly mothers-in-law where they control access to family resources.

Health and medical research in Nepal: a bibliometric review.

This study aimed to quantify the following: (1) health research in academic journals covering Nepal, (2) location of authors, and (3) most prevalent specialties. Published health research conducted in Nepal during 1996 to May 2007 was assessed by searching from 4 electronic databases, and 631 research articles met the inclusion criteria. Only 11% was published in Nepalese journals. Most research covered urban districts. About two thirds of articles had Nepalese authors, but only 41% had a Nepalese first author. Child health and nutrition (11%), maternal health and women's health (11%), and sexual reproductive health and HIV/AIDS, and family planning (11%) were the most common topics. Most articles (78%) reported quantitative methods. The number of research articles from Nepal is fairly small and concentrated on a limited number of topics and districts. Strategic planning is required to improve the research capacity of Nepal to achieve public health improvements using locally produced evidence.