Protocol For Mixed Methods Study Research Articles

Implementation and evaluation of the WHO maternity care model: a convergent parallel mixed-methods study protocol.

According to the World Health Organization (WHO), intrapartum care is considered a platform for providing respectful, personalized, and women-centered services to women. This study aims to investigate the intrapartum care model proposed by WHO. This convergent parallel mixed-methods study will be carried out in qualitative and quantitative phases. In the quantitative phase (a quasi-experimental study), 108 pregnant women admitted to the maternity ward will be randomized to intervention (receiving intrapartum care based on the WHO model) and control group (receiving routine hospital care) before the beginning of the active stage of labor (cervix dilatation equal to 5 cm) and Wijma's delivery fear scale (DFS) will be completed for them and again at 7-8 cm dilatation. The participants of both groups will be followed up for 6 weeks after labor and then they will be invited to a relatively quiet place to complete the Childbirth Experience Questionnaire (CEQ 2.0), the Edinburgh Postpartum Depression Scale (EPDS), the Post-Traumatic Stress Disorder (PTSD) Symptom Scale (PSS-I), the Pregnancy and Childbirth Questionnaire (PCQ), exclusive breastfeeding and a checklist on willingness to give birth to another child. The qualitative phase will employ content analysis to explain mothers' views about the effects of this model especially subjective components of this model on their labor process after 4-6 weeks. The two phase's results will be discussed in combination. The implementation of such care models is expected to prevent mental disorders caused by negative experiences of childbirth, and also, prevent uncontrolled increases in cesarean sections. https://fa.irct.ir/user/trial/68313/view, identifier (IRCT20120718010324N69).

A Protocol for Patients' Education Based on Andragogy: A Convergent Parallel Mixed Methods Study

Background: Patients' education is a key factor in patients' care. The purpose of this study is to design a protocol for a convergent parallel mixed methods study to explore the experiences of patients about their received educations based on andragogy model. Methods: This convergent parallel mixed method study includes two parallel quantitative and qualitative phases. During the quantitative phase, a cross-sectional survey will be conducted on 350 adult patients who had the history of hospitalization and received patient education from selected hospitals of Tehran, Iran. Sampling method will be random, and data collection tool will be a researcher-made questionnaire based on the principles of andragogy. The questionnaire’s validity and reliability are also measured, and data will be analyzed using SPSS 16. The qualitative phase will be conducted on adult patients who will be recruited purposively with maximum variation from the selected hospitals. Data will be gathered through semi-structured interviews and analyzed by directed content analysis. With regard to mixed method and using aligning convergence method, the results of the two sets of data will be compared or merged to see if the findings confirm or disconfirm each other. In this parallel section, the similarities between quantitative and qualitative results for assessing patient education are discussed and adapted to suit each other based on andragogy. Conclusions: The findings of this study will provide information regarding defects in patient education, suggesting that the principles of andragogy will develop patient education programs.

Implementation and evaluation of the centering pregnancy group prenatal care model in pregnant women with diabetes: a convergent parallel mixed methods study protocol

BackgroundDiabetes during pregnancy has negative effects on both mothers and their fetuses. To improve perinatal outcomes and women’s experience of care, the World Health Organization (WHO) suggests implementing health system interventions to enhance the use and quality of antenatal care. The main goal of this study is to implement and evaluate the outcomes of the Centering Pregnancy group care model for pregnant women with diabetes.Methods/designThe study will consist of three phases: a quantitative phase, a qualitative phase, and a mixed phase. In the quantitative phase, a randomized controlled trial will be conducted on 100 pregnant women with diabetes receiving prenatal care in Tabriz City, Iran. The Summary of Diabetes Self-Care Activities (SDSCA) questionnaire will also be validated in this phase. The qualitative phase will use qualitative content analysis with in-depth and semi-structured individual interviews to explore pregnant women’s understanding of the impact of the Centering Pregnancy group care model on their care process. The mixed phase will focus on the degree and extent of convergence between quantitative and qualitative data.DiscussionThe implementation of the Centering Pregnancy group care approach is anticipated to empower women in effectively managing their diabetes during pregnancy, resulting in improved outcomes for both mothers and newborns. Furthermore, adopting this approach has the potential to alleviate the financial burden of diabetes on healthcare system.Trial registrationIranian Registry of Clinical Trials (IRCT): (IRCT20120718010324N80/ Date of registration: 2024-01-03). URL: https://irct.behdasht.gov.ir/trial/74206.

Occupational exposures among women beedi workers in Mysore District, India: A mixed-methods study protocol.

Beedi is the most common smoking form of tobacco used in India. The rolling of beedis is performed primarily by women in settings that lack occupational safeguards. The aims of this protocol are to establish methods for the study of occupational exposures among women beedi workers and their experiences and challenges working with unburnt tobacco. This protocol employs a convergent parallel mixed-methods approach. Qualitatively, we plan to explore the experiences and challenges faced by women beedi workers using photovoice, a community based participatory method. Occupational exposures to pesticides will be assessed through the use of silicone wristbands worn for seven days by workers, and exposure to toxic metals and metalloids will be assessed in dust samples collected in the homes of workers. The outcomes will be analyzed to form policy recommendations to improve the occupational health of women beedi workers.

Mixed Methods EvAluation of the high-volume low-complexity Surgical hUb pRogrammE (MEASURE): a mixed methods study protocol

IntroductionThe waiting list for elective surgery in England recently reached over 7.8 million people and waiting time targets have been missed since 2010. The high-volume low complexity (HVLC) surgical hubs...

Frequency of self-directed dying in the Netherlands: research protocol of a cross-sectional mixed-methods study

IntroductionIn the Netherlands, assisting in suicide is allowed for physicians and regulated by the Termination of Life on Request and Assisted Suicide (review procedures) Act. However, some people decide to...

Development of a Health Impact Assessment Implementation Model: Enhancing Intersectoral Approaches in Tackling Health Inequalities- A Mixed Methods Study Protocol

Public health research presents compelling evidence that health is socially determined. To address structural inequalities and inequities in health, public policies require intersectoral development and implementation. Health Impact Assessment (HIA) is an established approach for analysing potentially detrimental health impacts of policies, programmes, and projects, as well as potentially positive impacts and opportunities. National public health policy, Healthy Ireland (2013–2025), endorses an intersectoral whole-of-system approach to ensure that health is a central part of all relevant policy areas. HIA is endorsed in this policy as one way to drive this agenda. Synergising with this policy commitment for HIA, the all-island Institute of Public Health Ireland produced revised HIA guidance in 2021. Two HIAs will be carried out as part of this project, including one at a local policy level, addressing the Cork City Development Plan (2022–2028), and the second HIA at a national policy level, addressing the Irish Government’s Climate Action Plan (2024). The updated HIA guidance will be used in the conduct of these HIAs. This research project involves a co-creation of a Health Impact Assessment Implementation Model by employing an action research approach with implementation science frameworks to the conduct of the two HIAs. Therefore, the process of doing the HIAs will form the basis for the research study. In order to enhance meaningful community involvement in HIA in Ireland, the project will co-create a Community Engagement Toolkit for HIA. This Model will strengthen researcher, policy actor, practitioner, community, and voluntary sector capacity to collaboratively develop and implement intersectoral and equitable policy responses to major population health issues.

Integrating perspectives of transgender and gender-diverse youth, family members, and professionals to support their health and wellbeing – a mixed-method study protocol

BackgroundThe current literature highlights a strong link between the poor health outcomes of transgender and gender diverse (TGD) individuals and their negative experiences in various areas of life. Most of these publications rely on adults’ memories, lacking a focus on the current experiences and needs of young transgender and gender-diverse individuals. Furthermore, previous studies on support for these young people often solely consider the perspectives of TGD adults or professionals and rarely involve parents’ viewpoints.MethodsThis study will use a mixed sequential method with a participatory approach. Firstly, the qualitative phase will explore the difficulties and needs of TGD (15–20 years old) and of the families and professionals who support them. Results from this part will be used to develop the questionnaire for the quantitative phase, with the help of a community board. Secondly, based on participatory epidemiological research, the quantitative phase will use an intersectional perspective to measure the impact of individual and structural factors on the quality of life and well-being of transgender and gender-diverse young people. Finally, a co-creation phase will be undertaken to formulate recommendations based on the results of the first two phases.DiscussionThis research aims at better understanding the influence of gender identity on the quality of life and health of TGD young people and their families and to identify protective and risk factors that affect their vulnerabilities.Ethics and disseminationThis study has been approved by the Ethics Committee of the Erasme Faculty Hospital (CCB B4062023000140). As this research is participatory and part of a PhD dissertation, we aim to disseminate the results through our partners’ networks and structures locally, and internationally through conferences and peer-reviewed journals.

CHAMPP4KIDS: Mixed methods study protocol to evaluate acceptability and feasibility of Parenting for Lifelong Health materials in a Canadian context.

Parents and caregivers play a key role in children's healthy development and well-being. Traditional parenting interventions promote positive parenting practices and are key to preventing child maltreatment. However, numerous barriers can limit access to programs, barriers which were further exacerbated by the COVID-19 pandemic. The Parenting for Lifelong Health group developed mass media and public health communication materials to promote positive caregiving behaviours on a population level. The Champions of Positive Parenting 4 Kids (CHAMPP4KIDS) study will examine the acceptability and feasibility of these materials for service providers and caregivers of children aged 2-6 years in Ontario, Canada. This study will use a convergent mixed-methods design. Consenting service providers (n = 200) and caregivers (n = 100) will complete a quantitative survey to rate, rank and give feedback on Parenting for Lifelong Health tip sheets and social media ads. Caregivers will also complete self-report scales measuring depression and anxiety. We will hold focus group discussions with a sub-sample of surveyed providers (n = 40) and caregivers (n = 25). An adapted Trials of Improved Practices methodology will explore caregiver perspectives after implementing the tip sheets. Primary quantitative outcomes will be descriptive statistics of rankings, Likert Scale scores and descriptive analysis of caregiver depression and anxiety. Qualitative data will be analyzed using Rapid Qualitative Inquiry and triangulated through a convergent coding matrix. The Parenting for Lifelong Health COVID-19 parenting materials offer succinct, engaging parenting information in a mass media format that addresses some challenges associated with accessing in-person programming. The CHAMPP4KIDS study will provide mixed methods insights on the materials' acceptability and feasibility from different groups in a Canadian context, with a focus on marginalized families. The use of Trials of Improved Practices methodology could prove a useful tool for participant-led adaptation of existing parenting, early childhood development and other health intervention materials.

Evaluation of a complex couplet care intervention in a neonatal intensive care unit: A mixed methods study protocol.

Families with an infant in need of intensive care most often experience a harmful separation after birth. This is due to a division of medical specialties into neonatal care and maternal care. Therefore, a couplet care intervention is implemented for mother-infant dyads in a neonatal intensive care unit. This study protocol provides a comprehensive evaluation of the intervention. The aim is to evaluate the effect and implementation of a complex couplet care intervention to promote zero separation between mother and infant. The couplet care intervention is a family-centered model of care, where treatment-requiring mother-infant dyads will be admitted together and receive couplet care by neonatal nurses. The study adheres to the framework of the Medical Research Council and will use a mixed methods embedded design comprising a quasi-experimental trial and a qualitative process evaluation. Finally, a health economic evaluation will be conducted to assess the cost-effectiveness of this complex couplet care intervention. Separation of mother-infant dyads after birth has an adverse impact on family health and well-being. This study protocol evaluates a complex couplet care intervention. With this study, a first step is taken to help bridge the gap between current practices and a new care model to prevent the separation of mothers and their infants.

Self-help friendliness and cooperation with self-help groups among rehabilitation clinics in Germany (KoReS): a mixed-methods study protocol

IntroductionSelf-help is an important complement to medical rehabilitation for people with chronic diseases and disabilities. It contributes to stabilising rehabilitation success and further coping with disease and disability. Rehabilitation facilities...

Investigating healthcare workforce recruitment and retention: a mixed-methods study protocol

IntroductionAlthough the sustainability of the health workforce has been identified as essential to achieving health and wider development objectives, challenges with securing and retaining the healthcare workforce persist. In the...

Designing, validation and evaluation of the expert system of “Healthy Menopause” and assessing its effect on the management of menopause symptoms: an exploratory mixed method study protocol

BackgroundMenopause is a period of women’s life that has the especial physical, psychological and social challenges. So provision of an effective, practical and affordable way for meeting women’s related needs is important. In addition, women should be able to incorporate such programs into their daily work. Considering the dearth of suitable services in this regard, this study will be conducted with the aim of designing, validating and evaluating the “Healthy Menopause” expert system on the management of menopausal symptoms.Methods/designA mixed methods exploratory design will be used to conduct this study in 3 phases. The first phase is a qualitative conventional content analysis study with purposes of exploring the women’s experience of menopausal symptoms and extracting their needs, and collecting data about their expectations from a healthy menopause expert system.. The purposive sampling (In his phase data will be gathered through interviewing menopaused women aged 40 to 60 years old and other persons that have rich information in this regard and will be continued until data saturation. The second phase includes designing a healthy menopause expert system in this stage, the needs will be extracted from the qualitative findings along with a comprehensive literature review. The extracted needs will be again confirmed by the participants. Then, through a participatory approach (Participatory Design) using nominal group or Delphi technique the experts’ opinion about the priority needs of menopaused women and related solutions will be explored based on the categories of identified needs. Such findings will be used to design a healthy menopause expert system at this stage. The third phase of study is a quantitative research in which the evaluation of the healthy menopause expert system will be done through a randomized controlled clinical trial with the aim of determining the effect of the healthy menopause expert system on the management of menopause symptoms by menopausal women themselves.DiscussionThis is the first study that uses a mixed method approach for designing, validating and evaluating of the expert system “Healthy Menopause”. This study will fill the research gap in the field of improving menopausal symptoms and designing a healthy menopause expert system based on the needs of the large group of menopause women. We hope that by applying this expert system, the menopausal women be empowered to management and improving their health with an easy and affordable manner.

Developing a Core Outcome Set for Cytoreductive Surgery for Colorectal Cancer with Peritoneal Metastases: A Mixed-Method Study Protocol

As the number of centres offering cytoreductive surgery (CRS) for colorectal cancer with peritoneal metastases (CPMs) is increasing worldwide, research is focused on establishing better patient selection and ensuring that new techniques have positive impacts on survival. However, high-impact comparative research in this field is limited by the heterogeneity of outcome measurement and reporting. Additionally, as there are comparatively few randomised controlled trials reporting comprehensive patient-reported outcomes, it is possible that key stakeholders such as patients and carers are underrepresented in the current literature. A core outcome set (COS) for CRS with or without intraperitoneal chemotherapy for the treatment of CPMs, supported by clinicians and patients, will promote homogenous comparison across trials and optimise the utility of research findings. We have established a comprehensive protocol based on the Core Outcome Measures in Effectiveness Trials (COMETs) method to facilitate this. A systematic review will identify all the outcomes reported in the literature, whereas a semi-structured interview will identify outcomes considered important by patients and carers. The identified outcomes will populate an international Delhi survey, distributed to patients, carers, surgeons, oncologists, nurses, and allied health clinicians. Outcomes reaching international consensus of importance will be further discussed in a face-to-face workshop between patients, carers, and clinicians. This process will inform the development of a final COS for CRS for patients with CPMs.

Gender health gaps in guideline-based inpatient cardiovascular medical and nursing care and implementation strategies to reduce the gap (HeartGap): A mixed methods study protocol.

A growing body of evidence has demonstrated that a gender-sensitive approach to healthcare is needed in all areas of medicine. Although medical and nursing guidelines include gender-sensitive care (GSC+) recommendations, the level of implementation in health care practice is unknown. This study aims to examine the current level of implementation and acceptance of GSC+ among physicians and nurses and to identify potential gaps between guidelines and practice and barriers and facilitators of GSC+ implementation, taking the perceptions of all relevant stakeholders into account. The overarching aim is to develop holistic recommended actions to strengthen GSC+. This study has a mixed methods triangulation design. The preparation phase consisting of a literature review and a two-part (qualitative and quantitative) data analysis will be conducted in the cardiology department of 9 pilot hospitals in Berlin, North Rhine-Westphalia, Lower Saxony, Rhineland-Palatinate, Germany. 18 focus groups with clinicians and nurses as well as interviews with experts in other relevant fields will be performed. In the national roll-out phase, a questionnaire survey will be conducted with hospital clinicians (n = 382), nurses (n = 386) and patients (n = 388). This study will provide comprehensive insights into the implementation and acceptance of GSC+ in cardiology from the perspective of doctors, nurses, patients, stakeholders and experts in relevant fields, such as policy and education. A focus will also be on the extent to which age or gender of health professionals, region and hospital type influence the implementation of GSC+. The identification of GSC+ implementation barriers and facilitators should help to improve the standard of care for cardiology patients of all genders. The outcomes from this study can be used to develop measures and recommended actions for the successful and sustainable implementation of gender-sensitive care. The study is registered in the German Register of Clinical Studies (DRKS) under study number DRKS00031317.

Developing and testing culturally relevant bolt-on items for EQ-5D-5L in Chinese populations: a mixed-methods study protocol

IntroductionEQ-5D is one of the most frequently used health-related quality of life (HRQoL) measures but has been found to be insensitive in detecting differences in health status in some general...

Multicountry research on comprehensive abortion policy implementation in Latin America: a mixed-methods study protocol

IntroductionAccess to comprehensive abortion care could prevent the death of between 13 865 and 38 940 women and the associated morbidity of 5 million women worldwide. There have been some...

Investigating the barriers and enablers to outbreak reporting in the Asia-Pacific region: A mixed-methods study protocol.

The COVID-19 pandemic has raised concerns about the global capacity for timely outbreak reporting. However, gaps remain in our understanding of barriers and enablers to outbreak reporting, particularly at the local level. Field epidemiology training program (FETP) fellows often participate in the outbreak reporting process as part of both their training and the public health roles they assume after graduating; they therefore represent a potentially valuable source of information for better understanding these barriers and enablers. This study will investigate the barriers and enablers to outbreak reporting through a mixed methods approach that will encompass a review of the existing literature as well as surveying and interviewing FETP trainees and graduates from the Asia-Pacific region. This study will begin with a scoping review of the literature to identify existing evidence of barriers and enablers to outbreak reporting. Based on our findings from the scoping review, we will administer a survey to FETP trainees and graduates from the World Health Organization Western Pacific and South-East Asian Regions and conduct interviews with a subset of survey respondents to investigate the survey findings in more detail. We will summarise and compare the survey results according to various country-level economic and political indicators, and we will employ thematic analysis to evaluate the interview responses. Based on the findings from the scoping review, survey, and interviews, we will construct a model to comprehensively describe the various barriers and enablers to outbreak reporting. This study will contribute to our understanding of the determinants of outbreak reporting across several geographic, political, and economic contexts by eliciting the viewpoints and experiences of persons involved with outbreak reporting, particularly at the local level. This information will help improve the outbreak reporting process, allowing for more timely reporting and helping prevent future outbreaks from becoming pandemics.

Feasibility and acceptability of offering breast cancer risk assessment to general population women aged 30–39 years: a mixed-methods study protocol

IntroductionBreast cancer incidence starts to increase exponentially when women reach 30–39 years, hence before they are eligible for breast cancer screening. The introduction of breast cancer risk assessment for this...

Promoting social, emotional, and cognitive development in early childhood: A protocol for early valuation of a culturally adapted digital tool for supporting optimal childrearing practices.

The Thrive by Five app promotes positive interactions between children and parents, extended family, and trusted community members that support optimal socio-emotional and cognitive development in the early years. This article aims to describe the protocol for a prospective mixed-methods multi-site study evaluating Thrive by Five using surveys, interviews, workshops, audio diaries from citizen ethnographers and app usage data. The study activities and timelines differ by site, with an extensive longitudinal evaluation being conducted at two sites and a basic evaluation being conducted at five sites. The learnings from the more comprehensive evaluations inform the iterative research and development processes while also ensuring ongoing evaluation of usability, acceptability and effectiveness of the app and its content across varying contexts. The study evaluates: (1) the impact of the Thrive by Five content on caregiver knowledge, behaviours, attitudes and confidence; (2) how the content changes relationships at the familial, community and system level; (3) how cultural and contextual factors influence content engagement and effectiveness and (4) the processes that facilitate or disrupt the success of the implementation and dissemination. All in-country partners have been identified and data collection has been completed in Indonesia, Malaysia, Afghanistan, Kyrgyzstan, Uzbekistan, Namibia and Cameroon. Very few digital health solutions have been trialled for usability and effectiveness in diverse cultural contexts. By combining quantitative, qualitative, process and ethnographic methodologies, this innovative study informs the iterative and ongoing optimisation of the cultural and contextual sensitivity of the Thrive by Five content and the processes supporting implementation and dissemination.