Protocol For Mixed Methods Study Research Articles

Development of a modified physiological birth programme integrated into Iran’s health system and its effect on maternal and neonatal outcomes: an embedded mixed-methods study protocol

IntroductionAs recommended by the WHO, promotion of physiological birth is a main strategy to reduce the rate of caesarean section and achieve Sustainable Development Goals. A modified version of the...

Development of a person-centred digital platform for the long-term support of people living with an adult-onset genetic disease predisposition: a mixed-methods study protocol

IntroductionIndividuals at an inherited high-risk of developing adult-onset disease, such as breast cancer, are rare in the population. These individuals require lifelong clinical, psychological and reproductive assistance. After a positive...

Codesigning a user-centred digital psychoeducational tool for youth mental well-being with families in Canada: study protocol for a sequential exploratory mixed methods study

IntroductionOn 11 March 2020, WHO declared the novel coronavirus (COVID-19) disease a global pandemic. Governments globally implemented physical distancing measures and closure of public institutions that resulted in varying implications...

Intergenerational Reminiscence Approach in Improving Emotional Well-Being of Older Asian Americans in Early-Stage Dementia Using Virtual Reality: Protocol for an Explanatory Sequential Mixed Methods Study.

After a dementia diagnosis, Asian Americans experience anxiety, feelings of shame, and other negative effects. Emotional well-being is not only an important aspect of mental health, but also a quality of resilience that helps people bounce back faster from difficulties. However, few studies have addressed issues in developing, implementing, and testing intervention strategies to promote emotional well-being among older adults. Intergenerational solidarity between grandparents and grandchildren has been emphasized in Asian families and is beneficial for the health of persons with dementia. Reminiscence and life review have been identified as potentially effective intervention strategies for helping depression and emotional well-being for older adults. This proposed study aims to develop and implement an intergenerational reminiscence approach and evaluate its potential feasibility and effectiveness in improving the emotional well-being of older Asian American adults who have a recent dementia diagnosis. An explanatory sequential mixed methods design will be used in which quantitative data will first be collected and analyzed to identify subsamples of participants who report the greatest and least change in emotional well-being; then, these subsamples will be interviewed to further understand why or why not this intervention works for them. Older adults will receive 6 sessions of life review with grandchildren in virtual reality (VR; 1-1.5 hours each week for 6 weeks), aided by pictures and virtually traveling to important places in their life using Google Earth to look around at those places and remember important times. Quantitative survey data will be collected pre- and postintervention and at a 3-month follow-up. Qualitative interviews with selected participants will also be integrated into the study design. The quantitative data from the surveys will be entered into SPSS (IBM Corp) and analyzed using descriptive analyses, Pearson chi-square tests, nonparametric Friedman tests, or nonparametric Wilcox signed-rank tests (2-tailed). The qualitative data will be transcribed by research assistants, coded by the investigators independently, and analyzed with guidance from content analysis software (Atlas.ti; Atlas.ti Scientific Software Development GmbH). The project was delayed due to the COVID-19 pandemic. Data collection started in late 2021, and 26 participants were recruited as of December 2022. While we are still cleaning and analyzing the quantitative data, the qualitative interviews showed promising results of this intergenerational reminiscence approach in improving emotional well-being among older Asian American adults who have cognitive impairment. Intergenerational reminiscence provided by grandchildren is promising in improving the emotional well-being of grandparents. VR technology is likely to be accepted by older adults. Future research may consider scaling up this pilot into a trackable, replicable model that includes more participants and develops a more rigorous study design with control groups to test the effectiveness of this intervention for older adults with dementia. DERR1-10.2196/48927.

The Design, Development, and Usability Testing of an eHealth Program for Youths With Osteogenesis Imperfecta: Protocol for a 2-Phase User-Centered Mixed Methods Study.

Innovative approaches are needed to address the self-management needs of youths with osteogenesis imperfecta (OI) transitioning into adult-oriented health care systems. Using a sequentially phased research approach, the goal is to design, develop, and test the usability of an innovative eHealth program called "Teens Taking Charge: Managing OI Online," hereafter named "Teens OI." This program seeks to optimize self-management, facilitate a successful transition to adult care, and address a critical gap in the quality of care for youths with OI. The study objectives are to (1) design and develop an English and French version of the Teens OI and (2) test the usability of the Teens OI in terms of efficiency, effectiveness, and satisfaction from the perspectives of youths with OI and their parents. A user-centered design is presently in progress to design and develop Teens OI. A "Website Design and Development Council" (ie, Council) has been convened, with 20 youths and parent dyads recruited and global experts surveyed at an international meeting. With unanimous support from the Council, usability testing of the Teens OI will ensue in 4 iterative cycles with 32 youth-parent dyads. All sociodemographic and usability metrics will be descriptively analyzed. All recorded interview and focus group data are analyzed using content analysis techniques involving an iterative process of data reduction, data display, conclusion drawing, and verification. As of December 2022, an 8-person, interdisciplinary Teens OI council, comprising 4 health care professionals, 3 youths and young adults with OI, and 1 parent, has been convened to oversee the design and development of Teens OI. Two cycles of interviews have been conducted with 10 youths with OI with or without their parents (n=6) from December 2021 to September 2022. Data analysis has been in progress since April 2022. Aim 2 is ethically approved and will commence following the completion of content development, expected by late July 2023. Preliminary analysis indicates that the following topics need to be prioritized for the youths: mental health, pain, accessibility, medical care, education, community, and parental care. The proposed study will design and develop a self-management and transitional care program for youths with OI in partnership with patients, caregivers, and health care professionals. This study leverages youths' openness to adopt eHealth technologies to meet their needs and has the potential to actively engage them to autonomously manage their lifelong conditions, and facilitate a successful transition to adult health care. Finally, the proposed study will also address a critical gap in the quality of care and the growing concern that the OI population transitioning from pediatric to adult care is at risk of various adverse events associated with the transition. DERR1-10.2196/47524.

Evaluation of woman-centred care status by Iranian midwives and providing strategies to improve women-centred care: A sequential explanatory mixed method study protocol.

The present study aimed to evaluate the status of WCC provided by Iranian midwives. A sequential explanatory mixed method study protocol. The present study was conducted in three phases: quantitative, qualitative and mixed. The first phase is a cross-sectional study that will be performed on midwives working in health centres, public and private hospitals in Iranian. The second phase is a qualitative study, in which purposeful sampling will be used, meaning that the midwives who are part of the extreme cases according to the results of quantitative phase and are willing and able to express their own experiences regarding WCC will be selected. Also, pregnant and parturient women under their cover will also be interviewed. Finally, in the mixed phase, we will use a combination of two quantitative and qualitative studies, a literature review and expert opinion using a Delphi method to provide strategies to improve and promote WCC in midwives. Achieving this goal is expected to provide positive outcomes such as strengthening the midwives professional relationship with women and reducing health care costs. No Patient or Public Contribution.

Examining decisional needs and contextual factors influencing fertility status assessment among young female survivors of childhood cancer: A sequential mixed methods study protocol.

Female cancer survivors who received gonadotoxic cancer treatment are at risk for profound diminished ovarian reserve and/or primary ovarian insufficiency with resulting infertility, which can be associated with distress and decreased quality of life.. Despite prioritizing future parenthood, many survivors are unsure of the impact of their treatment on their future fertility, and little is known about the perceived reproductive health needs and factors associated with receipt of a fertility status assessment (FSA). There is a lack of developmentally appropriate reproductive health decisional support interventions available for emerging adult cancer survivors. This study will explore the perceived reproductive health needs of emerging adult female survivors of childhood cancer and to identify decisional and contextual factors that influence pursuit of FSA using an explanatory sequential quantitative to qualitative mixed methods design. This study will enroll 325 female survivors (aged 18 to 29 years and >1-year post treatment; diagnosed with cancer < age 21 years) from four cancer centers in the United States. Sociodemographic and developmental factors, reproductive knowledge and values, decisional needs, and receipt of an FSA will be assessed through a web-based survey. Informed by survey findings, a subset of participants will be recruited for qualitative interviews to explore decisional factors associated with uptake of an FSA. Clinical data will be abstracted from the medical records. Multivariable logistic regression models will be developed to identify factors associated with FSA and qualitative descriptive analysis will be used to develop themes from the interviews. Quantitative and qualitative findings will be merged using a joint display to develop integrated study conclusions and direct future interventional research.

Treatment burden in multiple long-term conditions: a mixed-methods study protocol.

Treatment burden represents the work patients undertake because of their health care, and the impact of that effort on the patient. Most research has focused on older adults (aged >65 years) with multiple long-term conditions (multimorbidity) (MLTC-M), but there are now more younger adults (aged 18-65 years) living with MLTC-M and they may experience treatment burden differently. Understanding experiences of treatment burden, and identifying those most at risk of high treatment burden, are important for designing primary care services to meet their needs. To understand the treatment burden associated with MLTC-M, for people aged 18-65 years, and how primary care services affect this burden. Mixed-methods study in up to 33 primary care practices in two UK regions. The following two approaches will be used: (i) in-depth qualitative interviews with adults living with MLTC-M (approximately 40 participants) to understand their experiences of treatment burden and the impact of primary care, with a think-aloud aspect to explore face validity of a novel short treatment burden questionnaire (STBQ) for routine clinical use in the initial 15 interviews; (ii) cross-sectional patient survey (approximately 1000 participants), with linked routine medical record data to examine the factors associated with treatment burden for people living with MLTC-M, and to test the validity of STBQ. This study will generate in-depth understanding of the treatment burden experienced by people aged 18-65 years living with MLTC-M, and how primary care services affect this burden. This will inform further development and testing of interventions to reduce treatment burden, and potentially influence MLTC-M trajectories and improve health outcomes.

Clinicians', patients' and carers' perspectives on borderline personality disorder in Pakistan: A mixed methods study protocol.

Borderline Personality Disorder (BPD) is a condition characterised by significant social and occupational impairment and high rates of suicide. In high income countries, mental health professionals carry negative attitudes towards patients with BPD, find it difficult to work with patients with BPD, and even avoid seeing these patients. Negative attitudes and stigma can cause patients to fear mistreatment by health care providers and create additional barriers to care. Patients' self-stigma and illness understanding BPD also affects treatment engagement and outcomes; better knowledge about mental illness predicts intentions to seek care. The perspectives of mental health clinicians and patients on BPD have not been researched in the Pakistani setting and likely differ from other settings due to economic, cultural, and health care system differences. Our study aims to understand the attitudes of mental health clinicians towards patients with BPD in Pakistan using a self-report survey. We also aim to explore explanatory models of illness in individuals with BPD and their family members/carers using a Short Explanatory Model Interview (SEMI). The results of this study are important as we know attitudes and illness understanding greatly impact care. Results of this study will help guide BPD-specific training for mental health clinicians who care for patients with BPD and help inform approaches to interventions for patients with BPD in Pakistan.

Biopsychosocial approach to understanding predictors of depressive symptoms among men who have sex with men living with HIV in Selangor, Malaysia: A mixed methods study protocol.

Depression is the most common psychiatric disorder reported among patients living with Human Immunodeficiency Virus (HIV), resulting from the intricate combination of biological, psychological, and social factors. Biopsychosocial factors can significantly impact the psychological well-being of men who have sex with men (MSM) living with HIV through social stigma, access and compliance to care, economic insecurity, relationship difficulties, and risky behavior. Compared to MSM without HIV, MSM living with HIV were more likely to be depressed. Despite specific vulnerabilities and health needs, MSM living with HIV remain understudied and underserved in Malaysia owing to legal, ethical, and social challenges. This is merely a published protocol, not the findings of a future study. This study aims to determine and explain the predictors of depressive symptoms among MSM living with HIV. Specifically, this study wants to determine the association between depressive symptoms among MSM living with HIV and biological, psychosocial, and social factors. Finally, the mixed methods will answer to what extent the qualitative results confirm the quantitative results of the predictors of depressive symptoms among MSM living with HIV. The study has ethical approval from the Medical Research Ethics Committee (MREC) of the Ministry of Health (MOH) NMRR ID-21-02210-MIT. This study will apply an explanatory sequential mixed methods study design. It comprised two distinct phases: quantitative and qualitative study design for answering the research questions and hypothesis. This study will randomly recruit 941 MSM living with HIV in the quantitative phase, and at least 20 MSM living with HIV purposively will be selected in the qualitative phase. The study will be conducted in ten public Primary Care Clinics in Selangor, Malaysia. A self-administered questionnaire will gather the MSM's background and social, psychological, and biological factors that could be associated with depressive symptoms. For the quantitative study, descriptive analysis and simple logistic regression will be used for data analysis. Then, variables with a P value < 0.25 will be included in multiple logistic regression to measure the predictors of depressive symptoms. In the qualitative data collection, in-depth interviews will be conducted among those with moderate to severe depressive symptoms from the quantitative phase. The thematic analysis will be used for data analysis in the qualitative phase. Integration occurs at study design, method level, and later during interpretation and report writing. The quantitative phase was conducted between March 2022 to February 2023, while qualitative data collection is from March 2023 to April 2023, with baseline results anticipated in June 2023. In combination, qualitative and quantitative research provides a better understanding of depressive symptoms among MSM living with HIV. The result could guide us to provide a comprehensive mental healthcare program toward Ending the AIDS epidemic by 2030.

Home-based cardiac rehabilitation: development, implementation and outcome evaluation in patients with coronary artery diseases in Lahore, Pakistan – a mixed-methods study protocol

IntroductionCardiac rehabilitation (CR) is an important strategy to bring cardiac patients back to a normal life after a cardiac event. The benefits of CR as part of secondary prevention are...

Identifying and addressing the impacts of the COVID-19 pandemic on school-based immunisation programmes in the Canadian Maritimes: a mixed methods study protocol

IntroductionThe COVID-19 pandemic highlighted the importance of keeping up to date on routine vaccinations. Throughout the pandemic, many routine vaccine programmes in Canada were paused or cancelled, including school-based immunisation...

Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol

IntroductionMental health services are stretched in the UK and are in need of support. One approach that could improve mental health symptoms is osteopathy. Research suggests that osteopathy influences psychophysiological...

Comprehensive coordinated community based palliative care (C3PaC) model for cancer patients in North India: a mixed-method implementation research study protocol

BackgroundCancer remains an escalating and challenging public health issue. The management, especially palliative care (PC), is disintegrated and out of reach of in need patients. The overall aim of the project is to develop a feasible and scalable Comprehensive Coordinated Community based PC model for Cancer Patients (C3PaC); congruent with socio-cultural, context and unmet needs in north India.MethodsA mixed method approach will be used for three-phased pre- and post-intervention study in one of the districts of North India, having a high incidence of cancer. During phase I, validated tools will be used for quantitative assessment of palliative needs among cancer patients and their caregivers. Barriers and challenges for provision of palliative care will be explored using in-depth interviews and focus group discussions among participants and health care workers. The findings of phase I along with inputs from national experts and literature review will provide inputs for the development of the C3PAC model in phase II. During phase III C3PAC model will be deployed over a period of 12 months and its impact assessed. Categorical and continuous variables will be depicted as frequency (percentages) and mean ± SD/median (IQR) respectively. Chi-square test/Fischer test, independent samples Student t-tests and Mann–Whitney U tests will be used for categorical, normally and non-normally distributed continuous variables, respectively. Qualitative data will be analyzed using thematic analysis using Atlas.ti 8 software.DiscussionThe proposed model is designed to address the unmet palliative care needs, to empower community-based healthcare providers in comprehensive home-based PC and to improve the quality of life of cancer patients and caregivers. This model will provide pragmatic scalable solutions in comparable health systems particularly in low- and lower-middle Income countries.Trial registrationThe study has been registered with the Clinical Trial Registry-India (CTRI/2023/04/051357).

Examining Diabetes Distress in Pre-existing Diabetes in Pregnancy: Protocol for an Explanatory Sequential Mixed Methods Study

Diabetes distress has been shown to be highly prevalent in adults living with type 1 and type 2 diabetes with important implications for glycemic control, self-care, and self-management behaviors. Despite considerable focus on self-management and glycemic targets during pregnancy, current literature lacks information on diabetes distress in pregnancy, particularly in women with type 2 diabetes. This article outlines an explanatory sequential mixed methods research protocol to examine diabetes distress during pregnancy in women with pre-existing diabetes. The aims of the study were to: (1) establish the prevalence and correlates of diabetes distress in women attending a diabetes and pregnancy clinic; (2) use this quantitative data to inform development of an interview guide and plan for sampling for telephone interviews; and (3) explore and describe the experiences of diabetes distress during pregnancy. The quantitative strand was a cross-sectional survey of 76 women using self-reported questionnaires to collect demographic and clinical data, and validated tools to assess health variables, including the outcome of interest of diabetes distress using the Problem Area in Diabetes scale. The qualitative strand applied interpretive description methodology to explore the quantitative results using semi-structured qualitative interviews with 18 women to obtain patient perspectives of diabetes distress and experiences of managing diabetes in pregnancy. The explanatory sequential mixed methods research will provide an opportunity to add contextual qualitative experiences from women with pre-existing diabetes during pregnancy to provide a comprehensive picture of diabetes distress. The results will inform further research priorities that protect and promote mental health, psychosocial well-being, and self-management practices for this population.

A mixed-methods study protocol on the psychosocial health of stroke survivors and their informal carers (CARESS): experiences, needs and quality of life

Introduction: Surviving a stroke and caring for a survivor, impacts individuals’ psychological health and quality of life, which may impose substantial costs on healthcare and social systems. This study aims to understand and explore the psychological health, experiences, needs and quality of life of Portuguese stroke survivors and their informal carers. Methods and analysis: This is a mixed-methods, observational study. The methodological strategy relies on 1) scoping review; 2) questionnaires to stroke survivors hospitalized between September 2018 and August 2019 in one of the 12 Stroke Units of the Northern Region Health Administration of Portugal and their informal carers, 18-24 months after the event (1775 survivors and 443 carers); and 3) semi-structured interviews to a subsample of stroke survivors (n = 49) and informal carers (n = 37); and 4) think tanks with stakeholders involved in the stroke rehabilitation process, namely stroke survivors, informal carers, researchers, and health and social professionals (n = 45). Descriptive and inferential statistics will be used to analyze the quantitative data, and content and interpretational analysis will be implemented to assess qualitative data. Ethics and dissemination: The study protocol was approved by the Ethics Committees of all the hospitals involved. The expected dissemination actions are effective tools in designing strategies that aim to promote knowledge on a needs-driven, socioethical sensitive basis, which will contribute to the implementation of a model of coproduction of health in the context of post-stroke care.

Role development, implementation and evaluation of nurse practitioners in a Belgian university hospital: a mixed methods study protocol

IntroductionDue to the increased prevalence of chronic conditions, multimorbidity and an increased complexity of care, the burden on healthcare teams is high resulting in unmet needs of patients and their...

Evaluating the implementation of the Mayo-Portland Adaptability Inventory-4 (MPAI-4) in three rehabilitation settings in Quebec: a mixed-methods study protocol

IntroductionStroke is a leading cause of morbidity and mortality worldwide, placing an immense burden on patients and the health system. Timely access to rehabilitation services can improve stroke survivors’ quality...

What counts as patient-important upper gastrointestinal bleeding in the ICU? A mixed-methods study protocol of patient and family perspectives

IntroductionClinically important upper gastrointestinal bleeding is conventionally defined as bleeding accompanied by haemodynamic changes, requiring red blood cell transfusions or other invasive interventions. However, it is unclear if this clinical...

Understanding Reproductive Health among Survivors of Paediatric and Young adults (URHSPY) cancers in Uganda: A mixed method study protocol.

Although reproductive failure after cancer treatment in children and young adults has been extensively described in high-income countries, there is a paucity of data in low-income settings. In addition, patient, parent, or health worker experiences, perspectives, and attitudes toward the risk of reproductive failure among young cancer patients in these settings are unknown. This study will describe the extent of reproductive morbidity associated with cancer treatment among childhood and young adult cancer survivors in Uganda. In addition, we aim to explore the contextual enablers and barriers to addressing cancer treatment-related reproductive morbidity in Uganda. This is an explanatory sequential mixed-method study. The quantitative phase will be a survey among childhood and young adult cancer survivors recruited from the Kampala Cancer Registry (KCR). The survey will utilize a Computer Assisted Telephone Interview (CATI) platform on a minimum of 362 survivors. The survey will obtain information on self-reported reproductive morbidity and access to oncofertility care. The qualitative phase will use grounded theory to explore contextual barriers and enablers to addressing reproductive morbidity associated with cancer treatment. The quantitative and qualitative phases will be integrated at the intermediate and results stage. Results from this study will inform the development of policy, guidelines, and programs supporting reproductive health among childhood and young adult cancer survivors.