The (un)controlled body: A grounded theory analysis to conceptualise stigma for women with gestational diabetes mellitus.

Health-related stigma is associated with adverse outcomes including depression, stress and reduced engagement in health behaviours which are particularly harmful in pregnancy and the postpartum. Women with gestational diabetes mellitus (GDM) report negative psychosocial experiences and may be at risk of stigma related to the condition. We aimed to understand women's experiences of GDM-specific stigma. Individual interviews were conducted with n = 53 women living in the UK with a current or past (within 4 years) GDM. Grounded theory methodology was used to analyse the data. Four themes were identified: (1) Preconceptions and misconceptions; (2) Locating, regaining, and negotiating agency; (3) Tension about and resisting the dominant discourse of stigma; and (4) Reclaiming control over the body. GDM-specific stigma was diverse and far reaching and may have broader implications for perinatal mental health and postnatal wellbeing. It is pertinent to investigate possible prospective associations between GDM-specific stigma, and biomedical and mental health outcomes.

A cognitive behavioural model of the bidirectional relationship between disordered eating and diabetes self care in adult men with Type 1 diabetes mellitus.

AIMS: This qualitative study aimed to develop the first cognitive behavioural (CBT) model outlining the development and maintenance of disordered eating in adult men living with Type 1 diabetes to improve on previous theoretical models of Type 1 diabetes and disordered eating and to draw comparisons to women with Type 1 diabetes and disordered eating. METHODS: Twenty-seven men (n = 16 with Type 1 diabetes and disordered eating, n = 11 with Type 1 diabetes without disordered eating) participated in semi-structured interviews. Data were analysed using thematic analysis and individual CBT formulations were developed for each participant to inform the model. RESULTS: Men with Type 1 diabetes and disordered eating experience negative thoughts about food, insulin, weight/shape and diabetes itself, which cause negative emotions such as fear and vulnerability and difficulties with diabetes self care such as problems with hyper and hypoglycaemia and problems accessing structured education and technology result in men feeling more dissatisfied about their body weight/shape. CONCLUSIONS: This CBT model of disordered eating in men with Type 1 diabetes can guide new interventions.

Protocol for the STEADY intervention for type 1 diabetes and disordered eating: Safe management of people with Type 1 diabetes and EAting Disorders studY.

This paper describes the protocol to test the feasibility of the Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY) intervention. STEADY is a novel complex intervention for people with type 1 diabetes and disordered eating (T1DE) of mild to moderate severity. The STEADY intervention integrates cognitive behavioural therapy (CBT) with diabetes education, and was developed using Experience-Based Co-Design. METHODS: The feasibility of STEADY will be tested using a randomised controlled feasibility trial. Forty adults with T1DE will be recruited and randomised into the STEADY intervention or treatment as usual control group. We will collect demographic, biomedical and psychometric data, routine glucose metrics and conduct the Structured Clinical Interview for DSM-5. Participants randomised to the STEADY intervention will receive 12 STEADY therapy sessions with a diabetes specialist nurse trained in CBT, delivered via videoconference and an optional smartphone app. The main outcome at 6 months will be the feasibility of STEADY (recruitment, dropout rates, feasibility of delivery). The secondary outcomes are biomedical (HbA1c and glucose time in range) and psychological (person-reported outcome measures in disordered eating, diabetes distress, depression and anxiety). A process evaluation will evaluate the fidelity, feasibility, acceptability and appropriateness of STEADY, and participant experiences. ETHICS AND DISSEMINATION: The protocol was approved by the East of England-Essex Research Ethics Committee (21/EE/0235). Study findings will be shared with study participants and disseminated through peer-reviewed publications and conference presentations.

"I Haven't Told Anyone but You": Experiences and Biopsychosocial Support Needs of People With Type 2 Diabetes and Binge Eating.

Up to 25% of people with type 2 diabetes (T2D) may binge eat which is almost 10 times as many as in the general population. Binge eating is associated with depression, anxiety, and social isolation. Moreover, binge eating may increase the risk of obesity and high blood glucose levels, both of which can accelerate the onset of complications to diabetes and death in people with T2D. Still, little is known about the experiences, needs, and preferences of people with T2D and binge eating that can inform and develop current and future treatment efforts. The aim of the study was therefore to gain in-depth insights into the experiences and biopsychosocial support needs of women and men with T2D and binge eating. Twenty semi-structured individual interviews (65% with females) were conducted and analyzed according to the methodology of Interpretive Description. Four themes were identified: (a) T2D and binge eating: Feeling trapped in a vicious circle; (b) Unwanted outcasts: Responding to continuous criticism; (c) Biomedical relief: Blaming and adjusting the body; and, (d) Silent struggles: Wanting to cease the secrecy. Pertinent to all themes were the guilt, shame, and worries about developing complications that the participants experienced when binge eating despite having T2D. Although binge eating triggered emotional distress, binge eating was at the same time a way of coping with such distress. Implications for treatment and future research are discussed, including the need to systematically assess and address binge eating in routine T2D care.

The quest for wellness: How to optimise self-care strategies for diabetic foot management?

Diabetic foot ulceration (DFU) is common and highly recurrent, negatively impacting the individuals' quality of life. The 2023 guidelines of the International Working Group on the Diabetic Foot emphasise that adherence to foot self-care recommendations is one of the most important factors in DFU prevention. These guidelines also briefly mention that depression and other psychosocial problems can hamper treatment and ulcer healing. Moreover, a new clinical question was added on psychological interventions for ulcer prevention, although the evidence regarding the role of psychological and social factors is still limited. To help the field progress, this narrative overview discusses how a stronger focus on psychological factors by both researchers and clinicians could improve the care for people at high DFU risk. The review starts with a testimony of a person living with DFU, explaining that for him, the absence of shared decision-making has been a key barrier to successful foot self-care implementation. Intervention studies that address patient-reported barriers are still scarce, and are therefore urgently needed. Furthermore, the key elements of psychological interventions found to be successful in managing diabetes are yet to be implemented in DFU risk management. Importantly, research evidence indicates that commonly advocated foot self-care recommendations may be insufficient in preventing DFU recurrence, whereas digital technology appears to effectively reduce recurrent DFU. More research is therefore needed to identify determinants of patient acceptance of digital technology.

Child educational progress in Born in Bradford pregnancies affected by gestational diabetes and also exposed to maternal common mental disorders.

Gestational diabetes and the maternal mental disorders of anxiety and depression have been implicated in adverse offspring neuro-behavioural outcomes but these exposures have only been studied in isolation. 1051 children whose mothers were diagnosed with gestational diabetes in UK's Born in Bradford cohort had linkage to maternal primary care records, providing diagnostic and treatment codes for depression and anxiety. Education record linkage provided results of the Early Years Foundation Stage Profile from the first year of school, aged five. Risk of not attaining a 'Good level of development' was analysed using multivariable Poisson regression within a generalised estimating equation framework. Multiple imputation was implemented for missing data. There was limited evidence of increased risk of failure to attain a 'good level of development' in those additionally exposed to maternal mental disorders (adjusted RR 1.21; 95% CI 0.94, 1.55). However, there was more evidence in children of Pakistani maternal ethnicity (adjusted RR 1.36; 95% CI 1.04, 1.77) than White British; this may have been driven by English not being the primary language spoken in the home. Therefore there may be groups with GDM in whom it is particularly important to optimise both maternal physical and mental health to improve child outcomes.

The impact of gestational diabetes mellitus on perceived mother-infant bonding: a qualitative study.

BACKGROUND: The prevalence of gestational diabetes mellitus (GDM) is rapidly increasing. It is associated with adverse physical and mental health outcomes for women and their babies. Mother-infant bonding is important for maternal health and infant development, but the effect of GDM on mother-infant bonding has not been examined. OBJECTIVE: To explore and describe the impact of GDM on perceived mother infant-bonding in the antenatal and postnatal period. METHODS: Qualitative, individual, semi-structured interviews were conducted with 33 women from diverse backgrounds with current or previous GDM. Data were analysed using reflexive inductive thematic analysis. RESULTS: Three main themes were generated from the analysis: 1) Concern for baby's health and its impact on bonding; 2) GDM management, the pregnancy experience, and bonding; 3) Continuity and discontinuity of the impact on bonding between the antenatal and postnatal periods. CONCLUSION: It was found that GDM can have both positive and negative impacts on perceived mother-infant bonding, which appear to change over the course of the perinatal period. Further observational research is needed to assist in understanding the impact of GDM on mother-infant bonding and the potential mediating effect of mental disorders, including depression.

"It feels like medically promoted disordered eating": The psychosocial impact of gestational diabetes mellitus in the perinatal period.

BACKGROUND: The global prevalence of gestational diabetes mellitus (GDM) is increasing, and it can significantly impact women's psychosocial outcomes in the perinatal period. The aim of this study was to explore the psychosocial impacts including experiences of support for women with GDM in the antenatal and postnatal period. METHODS: Semi-structured individual interviews were conducted with women (n = 33) living in the UK, who were either pregnant and recently diagnosed with GDM or had a previous GDM diagnosis within the past three years. Interviews were recorded, transcribed, and analysed using reflexive thematic analysis. FINDINGS: Analysis revealed six themes: 1. Diagnostic related frustration; 2. Impact on mental health; 3. The medicalisation of eating; 4. Losing agency to gain control; 5. Sourcing networks of support; 6. Current pregnancy; and future reproductive health. Each theme provides a unique insight into the experiences and psychological strain associated with GDM. From confusion and frustration at diagnosis, to the profound knock-on impact a diagnosis, associated lifestyle changes and medical appointments had on women's mental health, and the perceived medicalisation of their eating behaviours and patterns. CONCLUSION: Given the increasing prevalence of GDM and its wide-ranging psychosocial impacts, this study emphasises the need for healthcare professionals to consider the potential implications of GDM on women's psychosocial outcome, and to consider alternative support options outside of the medical system, such as peer support.

Gestational diabetes mellitus and its impact on the mother-infant relationship: A cohort study in the postnatal period.

Women with gestational diabetes mellitus (GDM) are at increased risk of poor perinatal mental health outcomes. However, the association between GDM and the mother-infant relationship is unclear. This study aimed to examine whether GDM itself impacts the mother-infant relationship and maternal mental health using a cohort study design. We used data from the Cohort of Newborns in Emilia-Romagna (CoNER) study, which included 642 women recruited in Bologna, Italy. Psychological data were collected at 6 and 15 months postnatally using a purpose designed measure to examine the mother-infant relationship. We used linear fixed effects and mixed-effects models to assess the effect of GDM on relationship scores at 6 and 15 months postpartum. Women with GDM had significantly lower relationship scores at 15 months postpartum [ß - 1.75 95% CrI (-3.31; -0.21)] but not at 6 months [ß - 0.27 95% CrI (-1.37; 0.81)]. Mother-infant relationship scores were significantly lower overall at 15 months compared to 6 months postpartum [ß - 0.29 95% CrI (-0.56; -0.02)]. Our findings suggest that there may be a delayed effect on the mother-infant relationship in response to the experience of GDM. Future research using large birth cohorts should investigate this further to confirm these findings, and whether women with GDM would benefit from early interventions to improve relationships taking into account length of time postpartum.

The diabetes insulin self-management education (DIME) intervention for people with type 2 diabetes starting insulin: a pilot feasibility randomised controlled trial.

OBJECTIVE: To determine the feasibility and acceptability of a diabetes insulin self-management education (DIME) group intervention for people with type 2 diabetes starting insulin. DESIGN: Single-centre parallel randomised pilot trial. SETTING: Primary care, South London, UK. SUBJECTS: Adults with type 2 diabetes, requiring insulin treatment, on maximum tolerated dose of 2 or more oral antidiabetic drugs with HbA1c > / = 7.5% (58 mmol/mol) on 2 occasions. We excluded people who were non-fluent in English; morbid obesity (BMI > / = 35 kg/m2); in employment that contraindicates insulin treatment; and those with severe depression, anxiety disorders, psychotic disorders, personality disorders, or cognitive impairment. METHODS: Participants were randomised using blocks of 2 or 4 to 3, 2-h group, face-to-face, DIME sessions or standard insulin group education sessions (control). We assessed feasibility according to consent to randomisation and attendance at intervention (DIME) and standard group insulin education sessions. Acceptability of the interventions was determined using exit interviews. We additionally measured change in self-reported insulin beliefs, diabetes distress and depressive symptoms between baseline and 6-month post-randomisation. RESULTS: There were 28 potentially eligible participants, of which 17 consented to randomisation, 9 were allocated to the DIME group intervention and 8 were allocated to the standard group insulin education. Three people withdrew from the study (1 from DIME and 2 from standard insulin education) before the start of the first session and did not complete baseline questionnaires. Of the remaining participants (n = 14), all DIME participants (n = 8) completed all 3 sessions, and all standard insulin education participants (n = 6) completed at least 1 standard insulin education session. The median group size was 2, the mean age of participants was 57.57 (SD 6.45) years, and 64% were female (n = 9). Exit interviews demonstrated that all participants (n = 7) found the group sessions acceptable, and thematic analysis of interview transcripts indicated social support, the content of group sessions and post-group experiences were positive, especially amongst DIME participants. There was improvement on self-report questionnaires. CONCLUSIONS: The DIME intervention was acceptable and feasible to deliver to participants with type 2 diabetes starting insulin in South London, UK. TRIAL REGISTRATION: International Study Registration Clinical Trial Network (ISRCTN registration number 13339678).

Healthcare professionals' experiences in identifying and supporting mental health problems in adults living with type 1 diabetes mellitus: A qualitative study.

AIMS: To explore perspectives and experiences of healthcare professionals in the identification and support provision of mental health problems in adults living with type 1 diabetes. METHODS: Using a qualitative research design, 15 healthcare professionals working in the United Kingdom were individually interviewed using a semi-structured interview schedule. Data were analysed using reflexive inductive thematic analysis. RESULTS: Four themes were identified relating to barriers: time, knowledge, relationship between services and stigma. Three themes were identified relating to facilitators: education, communication and appropriate tools and services. CONCLUSIONS: This research emphasises the need for educational tools to improve the skills and competency of healthcare professionals in identifying mental health problems in people with type 1 diabetes, highlighting practical and theoretical implications for healthcare improvements and the necessity for additional research to design care pathways that better support this population, in which all healthcare professionals are aware of.

Dietary intake, physical activity and sedentary behaviour patterns in a sample with established psychosis and associations with mental health symptomatology.

BACKGROUND: People with psychosis experience cardiometabolic comorbidities, including metabolic syndrome, coronary heart disease and diabetes. These physical comorbidities have been linked to diet, inactivity and the effects of the illness itself, including disorganisation, impairments in global function and amotivation associated with negative symptoms of schizophrenia or co-morbid depression. METHODS: We aimed to describe the dietary intake, physical activity (PA) and sedentary behaviour patterns of a sample of patients with established psychosis participating in the Improving Physical Health and Reducing Substance Use in Severe Mental Illness (IMPaCT) randomised controlled trial, and to explore the relationship between these lifestyle factors and mental health symptomatology. RESULTS: A majority of participants had poor dietary quality, low in fruit and vegetables and high in discretionary foods. Only 29.3% completed ⩾150 min of moderate and/or vigorous activity per week and 72.2% spent ⩾6 h per day sitting. Cross-sectional associations between negative symptoms, global function, and PA and sedentary behaviour were observed. Additionally, those with more negative symptoms receiving IMPaCT therapy had fewer positive changes in PA from baseline to 12-month follow-up than those with fewer negative symptoms at baseline. CONCLUSION: These results highlight the need for the development of multidisciplinary lifestyle and exercise interventions to target eating habits, PA and sedentary behaviour, and the need for further research on how to adapt lifestyle interventions to baseline mental status. Negative symptoms in particular may reduce patient's responses to lifestyle interventions.

Prevalence of mental disorders in people living with type 1 diabetes: A systematic literature review and meta-analysis.

OBJECTIVE: Type 1 diabetes is associated with increased prevalence of individual categories of mental disorders. We aimed to systematically synthesise the prevalence of all the different categories of mental disorders to estimate the overall burden of psychiatric morbidity in the type 1 diabetes population. METHOD: The electronic database of OVID was searched, and retrieved papers were screened for eligibility by two independent reviewers. Data were extracted using a standardised data extraction form and the quality of included papers was assessed. Where possible, comparisons with control groups without type 1 diabetes were made. Prevalence data were synthesised into Diagnostic and Statistical Manual of Mental Disorders version 5 categories, a narrative data-synthesis, and a subsequent meta-analysis where possible was conducted for mental disorder categories. RESULTS: Thirty-eight articles were included. Depressive, anxiety, and feeding and eating disorders were the most examined mental disorders. Studies utilising diagnostic interviews reported higher prevalence of mental disorders than in studies utilising clinical registers, with an up to 24-fold difference respectively. In studies with a control group, the prevalence for nearly every mental disorder were increased for the type 1 diabetes samples. CONCLUSIONS: There appears to be a high prevalence of mental disorders and associated need among people with type 1 diabetes, although the quality of research needs to improve. SYSTEMATIC REVIEW REGISTRATION: This protocol was submitted for registration with the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42020221530).

A thematic analysis of YouTube comments on a television documentary titled 'Diabulimia: The World's most dangerous eating disorder'.

AIM: Omitting insulin for fear of weight gain is a type of disordered eating (also labelled as diabulimia) common in type 1 diabetes (T1D) and is associated with a worse biomedical prognosis but is not a formally recognised condition. This research explored the public's opinion of diabulimia as a condition as presented in a television documentary. METHODS: We conducted a coding reliability thematic analysis using NVivo software of the original comments to a YouTube documentary 'Diabulimia: The World's Most Dangerous Eating Disorder' between 24 September 2017 and 16 June 2020. RESULTS: Of 1424 original comments, 1264 were eligible and uploaded into NVivo 12. The commenters were people with T1D, family and friends, health care professionals, and the wider public who collectively had questions, personal stories and/or opinions. Three main themes were discerned: lack of awareness of diabulimia as a condition; the importance of support; diabulimia as a psychiatric condition in the diabetes setting. CONCLUSION: This analysis of social media comments found that there is a lack of awareness of diabulimia amongst patients, their families and friends, and healthcare professionals and that there were many commenters who had the experience of disordered eating with T1D. This study has reported on themes that suggest there may be an eating disorder specifically in people with T1D and that further work is needed to understand the diagnostic criteria for diabulimia in order to develop effective treatments.

The gestational diabetes future diabetes prevention study (GODDESS): A partially randomised feasibility controlled trial.

OBJECTIVES: To assess the feasibility of an ante- and post-natal lifestyle intervention for women with gestational diabetes mellitus (GDM) to reduce type 2 diabetes risk. DESIGN: A partially randomised patient preference feasibility trial. SETTING: Diabetes antenatal clinics in two inner-London hospitals, UK. PARTICIPANTS: Pregnant women ≥18 years with a GDM diagnosis and pre-pregnancy body mass index of ≥25kg/m2. INTERVENTION: Participants in the intervention group were offered four motivational interview-based sessions (two antenatally and two postnatally, at 3 and 6 months postpartum), a WhatsApp support group, a FitBit and electronic self-help resources. OUTCOME MEASURES: Recruitment; retention; intervention dose received; data completion; adaptions; proportion achieving ≥5% weight loss; weight change, blood glucose; blood pressure; diet, physical activity, breastfeeding and depression. Clinical outcomes were measured at baseline and 6 months postpartum. RESULTS: 50 participants were recruited from 155 eligible women (32% recruitment rate). Thirty-four were recruited to the intervention group (23 following randomisation (RI-group) and 11 based on preference (PI-group)); and 16 to the control group (13 randomised (RC-group) and 3 preference (PC-group)). Attrition was 44% (n = 22/50). Forty-six percent (n = 6) of the intervention group (25% (n = 2) of the RI-group and 80% (n = 4) of the PI-group) achieved ≥5% weight loss compared to 8% (n = 1) in the control group (95% confidence interval (CI) -0.69 to 0.07). Mean weight change was -2.1kg±9.0 in the intervention group (0kg±5.4 in the RI-group and -5.4kg±13.0 in the PI-group) compared to +4.4kg±4.9 in the control group (RC +4.4kg ±5.3 and PC +4.7kg ±3.1, 95% CI -12.4 to 0.2). CONCLUSIONS: Recruitment was feasible, but strategies to improve retention are needed. The findings suggest the intervention can support women with GDM to lose weight. The observed weight loss was primarily in women who preferred the intervention. Therefore, future trials may need to adopt a preference design and consider factors associated with preference. TRIAL REGISTRATION: Trial registration: ISRCTN52675820 https://www.isrctn.com/ISRCTN52675820?q=ISRCTN52675820&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search.

Cardiometabolic risk profiles in a Sri Lankan twin and singleton sample.

INTRODUCTION: Prevention of cardiovascular disease and diabetes is a priority in low- and middle-income countries, especially in South Asia where these are leading causes of morbidity and mortality. The metabolic syndrome is a tool to identify cardiometabolic risk, but the validity of the metabolic syndrome as a clinical construct is debated. This study tested the existence of the metabolic syndrome, explored alternative cardiometabolic risk characterisations, and examined genetic and environmental factors in a South Asian population sample. METHODS: Data came from the Colombo Twin and Singleton follow-up Study, which recruited twins and singletons in Colombo, Sri Lanka, in 2012-2015 (n = 3476). Latent class analysis tested the clustering of metabolic syndrome indicators (waist circumference, high-density lipoprotein cholesterol, triglycerides, blood pressure, fasting plasma glucose, medications, and diabetes). Regression analyses tested cross-sectional associations between the identified latent cardiometabolic classes and sociodemographic covariates and health behaviours. Structural equation modelling estimated genetic and environmental contributions to cardiometabolic risk profiles. All analyses were stratified by sex (n = 1509 men, n = 1967 women). RESULTS: Three classes were identified in men: 1) "Healthy" (52.3%), 2) "Central obesity, high triglycerides, high fasting plasma glucose" (40.2%), and 3) "Central obesity, high triglycerides, diabetes" (7.6%). Four classes were identified in women: 1) "Healthy" (53.2%), 2) "Very high central obesity, low high-density lipoprotein cholesterol, raised fasting plasma glucose" (32.8%), 3) "Very high central obesity, diabetes" (7.2%) and 4) "Central obesity, hypertension, raised fasting plasma glucose" (6.8%). Older age in men and women, and high socioeconomic status in men, was associated with cardiometabolic risk classes, compared to the "Healthy" classes. In men, individual differences in cardiometabolic class membership were due to environmental effects. In women, genetic differences predicted class membership. CONCLUSION: The findings did not support the metabolic syndrome construct. Instead, distinct clinical profiles were identified for men and women, suggesting different aetiological pathways.

A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial.

BACKGROUND: Over 50% of women with a history of gestational diabetes mellitus (GDM) will develop type 2 diabetes (T2D) in later life. Asian women experience a disproportionate risk of both GDM and T2D compared to women from other ethnic backgrounds. Lifestyle interventions and behavior change can delay or even prevent the onset of T2D. We have developed a digitalized diabetes prevention intervention for the prevention of T2D in Malaysian women with GDM. OBJECTIVE: The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation. METHODS: This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212). RESULTS: Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022. CONCLUSIONS: To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future. TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.