Use of the 2021 UK Medical Research Council guidance to refine the Women's Wellness with Type 2 Diabetes Programme: a mixed-methods study.

BACKGROUND: The Women's Wellness with Type 2 Diabetes Programme (WWDP) is an online behavioural intervention for midlife women living with type 2 diabetes. The gender-specific intervention fosters self-efficacy, encouraging positive wellbeing behaviours to enhance diabetes and menopause outcomes. In 2016, We co-led a feasibility trial and process evaluation with 70 women aged 45-50 years from the UK and Australia. The intervention comprised an e-book, a website, and nurse consultations. The WWDP seemed to improved diabetes distress, self-efficacy, and menopausal symptoms, but with impactful, costly, diabetes nurse input, compromising feasibility and delivery by the NHS. We report WWDP refinement using the 2021 Medical Research Council (MRC) framework for complex interventions to optimise future implementation. METHODS: Intervention refinement was guided by six core MRC elements of context, programme theory, stakeholder engagement, key uncertainties, intervention refinement, and economic considerations. Critical analysis of quantitative and qualitative feasibility data, informed by self-efficacy theory, provided a deeper understanding of how the intervention was used. Eight PPI consultations took place between Sept 1, 2021, and Dec 31, 2022, with three women from diverse cultural and socioeconomic backgrounds and three female diabetes professionals to strengthen the e-book and methods of support for women undertaking the programme. FINDINGS: Context was improved by the feasibility study and the PPI consultations, making the e-book relevant to UK health care. Understanding that self-efficacy was supported through primary use of peer group, and goal setting components supported the existing programme theory. Stakeholder engagement shaped the structure of the online peer support group. The feasibility study revealed uncertainties around goal settings. These uncertainties were addressed by introducing individualised goals focusing on aspects like medication adherence. The nurse support in the intervention was replaced with peer support, which might lead to greater economic feasibility of the programme. An optimised website and individualised goal setting underpin the WWDP. INTERPRETATION: The MRC Framework provides intervention refinement structure, allowing adaptive adjustments based on emerging evidence, feedback, and contextual nuances. Limitations exist. Intervention refinements, including peer support, might affect adherence and unexpected interactions. New components could influence long-term efficacy. FUNDING: Turkish Ministry of National Education.

'No one ever asks about something that actually is relevant to my life': A qualitative study of diabetes and diabetes care experiences of young women with type 2 diabetes during their reproductive years.

AIM: To understand the health needs, experiences, and views of women with type 2 diabetes in relation to diabetes, reproductive health experiences, and general wellbeing. METHOD: A qualitative study using semi-structured interviews. Thirty-six women with type 2 diabetes (median age 37 years; age ranges 20-45 years; median diabetes duration 4.5 years), recruited through social media and charities in the UK (n = 23) and Turkey (n = 13). Video interviews (n = 28) were audio recorded and transcribed verbatim. Email interviews (n = 8) and transcribed video interviews were analysed using Framework Analysis. RESULTS: Two overarching themes were identified: (1) Perception of self and identity, (2) type 2 diabetes care is not orientated to women's needs. These themes highlight that living with type 2 diabetes was negatively perceived by the women in terms of their self-identity and reproductive health. Women reported that the diabetes care provided was often not appropriate or relevant to their health needs, and neglected issues of relevance to them. The women voiced ideas for enhancing current care to reflect their health needs, in particular the need for more emotional and peer-based support. CONCLUSION: Living with type 2 diabetes may negatively impact how women view themselves and how they relate to the roles they identify with such as, as a partner, mother, colleague. Current healthcare systems are not orientated to the specific needs of younger women with type 2 diabetes with limited opportunities to target their diabetes care around their health and wellbeing concerns and interests.

"It is like a pet in a way": The self-management experiences of people with cystic fibrosis diabetes.

BACKGROUND: Cystic fibrosis diabetes (CFD) is a very common co-morbidity affecting the lives of people with cystic fibrosis. Surprisingly, minimal research has been undertaken to understand the experiences of people with CFD and how they self-mange this condition. METHODS: Using interpretative phenomenological analysis, the present study examined the self-management experiences of people with CFD. In-depth semi-structure interviews were conducted with eight people who had CFD. RESULTS: The following three superordinate themes were identified: forming a relationship with CFD, balancing the CFD self-management triad, and the unmet need for information and support. CONCLUSIONS: The findings suggest that the management of CFD is challenging and, although people with CFD experience many adaptation and management processes similar to people with type 1 diabetes, they struggle with the additional complexity of balancing CF and CFD. The provision of appropriate education, support and person-centred care needs to be addressed.

Feasibility and acceptability of e-learning to upskill diabetes educators in supporting people experiencing diabetes distress: a pilot randomised controlled trial.

BACKGROUND: Diabetes distress is a commonly experienced negative emotional response to the ongoing burden of diabetes. Holistic diabetes care, including attention to diabetes distress, is recommended in clinical guidelines, yet not routinely implemented. Diabetes health professionals have highlighted lack of training as a barrier to implementation of psychological care. Therefore, we developed an e-learning: 'Diabetes distress e-learning: A course for diabetes educators' to address this need. This pilot study aimed to examine the feasibility of evaluating the e-learning in a randomised controlled trial study, the acceptability of the e-learning to credentialled diabetes educators (CDEs); and preliminary evidence of its effect upon CDEs' diabetes distress-related knowledge, motivation, confidence, behavioural skills, and barriers to implementation. METHODS: A pilot, unblinded, 2-armed, parallel group randomised controlled trial. Participants were recruited during a 4-month timeframe. Eligible participants were CDEs for ≥ 1 year providing care to ≥ 10 adults with type 1 or type 2 diabetes per week. Participants were randomly allocated (1:1 computer automated) to 1 of 2 learning activities: diabetes distress e-learning (intervention) or diabetes distress chapter (active control). They had 4 weeks to access the activity. They completed online surveys at baseline, 2-week and 12-week follow-up. RESULTS: Seventy-four eligible CDEs (36 intervention, 38 active control) participated. At baseline, recognition of the clinical importance of diabetes distress was high but knowledge and confidence to provide support were low-to-moderate. Engagement with learning activities was high (intervention: 83%; active control: 92%). Fifty-five percent returned at least 1 follow-up survey. All 30 intervention participants who returned the 2-week follow-up survey deemed the e-learning high quality and relevant. Systemic barriers (e.g., financial limitations and access to mental health professionals) to supporting people with diabetes distress were common at baseline and follow-up.  CONCLUSIONS: The e-learning was acceptable to CDEs. The study design was feasible but needs modification to improve follow-up survey return. The e-learning showed potential for improving diabetes distress-related knowledge, confidence and asking behaviours, but systemic barriers to implementation remained. Systemic barriers need to be addressed to facilitate implementation of support for diabetes distress in clinical practice. Future larger-scale evaluation of the e-learning is warranted.

The Effects of Psychological Interventions on Diabetic Peripheral Neuropathy: A Systematic Review and Meta-Analysis.

BACKGROUND: Psychological interventions are effective at ameliorating the experience of pain in conditions such as rheumatoid arthritis and chronic back pain. However, their effect on diabetic peripheral neuropathy (DPN) pain has yet to be established AIM: To assess the effectiveness of psychological interventions on pain and related outcomes in adults with DPN. DESIGN: Systematic review. SETTINGS: Community, hospital in-patient and out-patient. PARTICIPANTS/SUBJECTS: Adults with diabetic peripheral neuropathy. METHODS: Medline, Embase, PsychInfo, and CINAHL databases together with grey literature and trial registers were searched. A meta-analysis and narrative synthesis of included studies were undertaken. RESULTS: Nine studies were selected from 1610 citations. At short-term follow-up psychological therapies showed a large effect on pain severity (SMD = -0.94, 95%CI [-1.50, -0.37], p = .001), a small effect on pain interference (SMD = -0.39, 95%CI [-0.73, -0.05], p = .02), and a moderate effect on depressive symptoms (SMD = -0.58, 95%CI [-0.95, -0.21], p = .002). Quality of life significantly improved in experimental subjects, (MD = -2.35, 95%CI [-3.99, -0.71], p = .005). At medium-term follow-up there was a large effect on pain severity (SMD = -1.26, 95%CI [-1.76, -0.77], p < .00001) and on pain interference (SMD = -0.91, 95%CI [-1.61, -0.21], p = .01) and a moderate effect on depressive symptoms (SMD = -0.76, 95%CI [-1.48, -0.05], p = .04). At long-term follow-up, improvements in pain interference, mood, and self-care behaviors were reported. CONCLUSIONS: These findings demonstrate that the relationship between pain and perceived control identified in other groups who experience chronic pain may also be replicated in the DPN population. This is an important outcome that can guide further research and associated service developments.

The impact of online self-management interventions on midlife adults with type 2 diabetes: a systematic review.

BACKGROUND: Online self-management education programmes are now recommended for people with type 2 diabetes to improve self-management capacities. There is limited evidence to determine whether such programmes improve the health outcomes for midlife adults with diabetes. AIMS: The purpose of this systematic review was to assess the impact of online self-management interventions with digital consulting on glycated haemoglobin (HbA1c), total cholesterol, blood pressure, diabetes distress, self-efficacy, and depression in midlife adults. METHODS: A systematic review was undertaken searching Medline, Embase and CINAHL. Studies were appraised using the Cochrane Collaboration's tool. RESULTS: Eight studies were included. Online interventions resulted in the improvement of HbA1c (pooled mean difference on HbA1c: -0.35%, 95% CI (-0.52, -0.18), P<0.001). A narrative synthesis was conducted for all secondary outcomes. No conclusions could be drawn on the impact of these outcomes. CONCLUSION: Online interventions improve HbA1c. Further research is needed for secondary outcomes.

Assessing self-efficacy in type 2 diabetes management: validation of the Italian version of the Diabetes Management Self-Efficacy Scale (IT-DMSES).

BACKGROUND: Being highly self-efficacious is a key factor in successful chronic disease self-management. In the context of measuring self-efficacy in type 2 diabetes management, the Diabetes Management Self-Efficacy Scale (DMSES) is the most widely used scale. The aim of this study was to adapt the English version of the scale to Italian and to evaluate the psychometric properties of the Italian version of DMSES in type 2 diabetes (IT-DMSES). METHODS: We conducted a cross-sectional study of people with type 2 diabetes attending the Endocrine-Metabolic Disease Care Unit of the Internal Medicine Department of San Marino State Hospital between October 2016 and February 2017. Patients completed a socio-demographic and clinical data form, the IT-DMSES and 3 self-report questionnaires measuring diabetes distress (PAID-5), psychological well-being (WHO-5) and depression (PHQ-9). Psychometric testing included construct validity (principal component analysis), internal consistency (Cronbach's α coefficient) and convergent/discriminant validity (Spearman's correlation coefficient). Decision tree analysis was performed to classify patients into homogeneous subgroups of self-efficacy based on their demographic and clinical characteristics. RESULTS: Participants were 110 males and 55 females, mean age of 65.2 years (SD ± 9), 56.9% had been diagnosed for 1-15 years, 63% had HbA1c level > 53 mmol/mol. Two main factors underlain the construct of self-efficacy in diabetes management: 'Disease Management' and "Lifestyles Management". Disease Management had a good reliability (α = .849) and Lifestyle Management had an excellent reliability (α = .902) indicating that the instrument is internally consistent. A negative and weak correlation was found between Lifestyle management, PAID-5 (r = - 0.258, p = < 0.01) and PHQ-9 (r = - 0.274, p = < 0.01) and a positive one with WHO-5 (r = 0.325, p < 0.01) supporting convergent validity. Disease management was uncorrelated with PAID-5 (r = - 0.142, p = 0.083), PHQ-9 (r = - 0.145, p = 0.076) and weekly correlated with WHO-5 (r = 0.170, p = 0.037) confirming discriminant validity. Higher levels of self-efficacy in lifestyle management were found in patients diagnosed for at least 1 year up to 15 years and aged > 65 years and the poorest self-efficacy was found in males < 65 years. CONCLUSIONS: Results support the validity and reliability of IT-DMSES. The scale can be used in research and clinical practice to monitor type 2 diabetes self-management over time.

Ethical implications of digital communication for the patient-clinician relationship: analysis of interviews with clinicians and young adults with long term conditions (the LYNC study).

BACKGROUND: Digital communication between a patient and their clinician offers the potential for improved patient care, particularly for young people with long term conditions who are at risk of service disengagement. However, its use raises a number of ethical questions which have not been explored in empirical studies. The objective of this study was to examine, from the patient and clinician perspective, the ethical implications of the use of digital clinical communication in the context of young people living with long-term conditions. METHODS: A total of 129 semi-structured interviews, 59 with young people and 70 with healthcare professionals, from 20 United Kingdom (UK)-based specialist clinics were conducted as part of the LYNC study. Transcripts from five sites (cancer, liver, renal, cystic fibrosis and mental health) were read by a core team to identify explicit and implicit ethical issues and develop descriptive ethical codes. Our subsequent thematic analysis was developed iteratively with reference to professional and ethical norms. RESULTS: Clinician participants saw digital clinical communication as potentially increasing patient empowerment and autonomy; improving trust between patient and healthcare professional; and reducing harm because of rapid access to clinical advice. However, they also described ethical challenges, including: difficulty with defining and maintaining boundaries of confidentiality; uncertainty regarding the level of consent required; and blurring of the limits of a clinician's duty of care when unlimited access is possible. Paradoxically, the use of digital clinical communication can create dependence rather than promote autonomy in some patients. Patient participants varied in their understanding of, and concern about, confidentiality in the context of digital communication. An overarching theme emerging from the data was a shifting of the boundaries of the patient-clinician relationship and the professional duty of care in the context of use of clinical digital communication. CONCLUSIONS: The ethical implications of clinical digital communication are complex and go beyond concerns about confidentiality and consent. Any development of this form of communication should consider its impact on the patient-clinician-relationship, and include appropriate safeguards to ensure that professional ethical obligations are adhered to.

Eliciting the Impact of Digital Consulting for Young People Living With Long-Term Conditions (LYNC Study): Cognitive Interviews to Assess the Face and Content Validity of Two Patient-Reported Outcome Measures.

BACKGROUND: Digital consulting, using email, text, and Skype, is increasingly offered to young people accessing specialist care for long-term conditions. No patient-reported outcome measures (PROMs) have been evaluated for assessing outcomes of digital consulting. Systematic and scoping reviews, alongside patient involvement, revealed 2 candidate PROMs for this purpose: the patient activation measure (PAM) and the physician's humanistic behaviors questionnaire (PHBQ). PAM measures knowledge, beliefs, and skills that enable people to manage their long-term conditions. PHBQ assesses the presence of behaviors that are important to patients in their physician-patient interactions. OBJECTIVE: This study aimed to assess the face and content validity of PAM and PHBQ to explore whether they elicit important outcomes of digital consulting and whether the PROMs can isolate the digital consultation component of care. METHODS: Participants were drawn from 5 clinics providing specialist National Health Service care to 16- to 24-year-olds with long-term health conditions participating in the wider LYNC (Long-Term Conditions, Young People, Networked Communications) study. Overall, 14 people undertook a cognitive interview in this substudy. Of these, 7 participants were young people with either inflammatory bowel disease, cystic fibrosis, or cancer. The remaining 7 participants were clinicians who were convenience sampled. These included a clinical psychologist, 2 nurses, 3 consultant physicians, and a community youth worker practicing in cancer, diabetes, cystic fibrosis, and liver disease. Cognitive interviews were transcribed and analyzed, and a spreadsheet recorded the participants' PROM item appraisals. Illustrative quotes were extracted verbatim from the interviews for all participants. RESULTS: Young people found 11 of the PAM 13 items and 7 of the additional 8 PAM 22 items to be relevant to digital consulting. They were only able to provide spontaneous examples of digital consulting for 50% (11/22) of the items. Of the 7 clinicians, 4 appraised all PAM 13 items and 20 of the PAM 22 items to be relevant to evaluating digital consulting and articulated operationalization of the items with reference to their own digital consulting practice with greater ease than the young people. Appraising the PHBQ, in 14 of the 25 items, two-thirds of the young people's appraisals offered digital consulting examples with ease, suggesting that young people can detect and discern humanistic clinician behaviors via digital as well as face-to-face communication channels. Moreover, 17 of the 25 items were appraised as relevant by the young people. This finding was mirrored in the clinician appraisals. Both young people and the clinicians found the research task complex. Young participants required considerably more researcher prompting to elicit examples related to digital consulting rather than their face-to-face care. CONCLUSIONS: PAM and PHBQ have satisfactory face and content validity for evaluating digital consulting to warrant proceeding to psychometric evaluation. Completion instructions require revision to differentiate between digital and face-to-face consultations.

Digital Clinical Communication for Families and Caregivers of Children or Young People With Short- or Long-Term Conditions: Rapid Review.

BACKGROUND: The communication relationship between parents of children or young people with health conditions and health professionals is an important part of treatment, but it is unclear how far the use of digital clinical communication tools may affect this relationship. OBJECTIVE: The objective of our study was to describe, assess the feasibility of, and explore the impact of digital clinical communication between families or caregivers and health professionals. METHODS: We searched the literature using 5 electronic databases. We considered all types of study design published in the English language from January 2009 to August 2015. The population of interest included families and caregivers of children and young people aged less than 26 years with any type of health condition. The intervention was any technology permitting 2-way communication. RESULTS: We included 31 articles. The main designs were randomized controlled trials (RCTs; n=10), cross-sectional studies (n=9), pre- and postintervention uncontrolled (pre/post) studies (n=7), and qualitative interview studies (n=2); 6 had mixed-methods designs. In the majority of cases, we considered the quality rating to be fair. Many different types of health condition were represented. A breadth of digital communication tools were included: videoconferencing or videoconsultation (n=14), and Web messaging or emails (n=12). Health care professionals were mainly therapists or cognitive behavioral therapists (n=10), physicians (n=8), and nurses (n=6). Studies were very heterogeneous in terms of outcomes. Interventions were mainly evaluated using satisfaction or acceptance, or outcomes relating to feasibility. Clinical outcomes were rarely used. The RCTs showed that digital clinical communication had no impact in comparison with standard care. Uncontrolled pre/post studies showed good rates of satisfaction or acceptance. Some economic studies suggested that digital clinical communication may save costs. CONCLUSIONS: This rapid review showed an emerging body of literature on the use of digital clinical communication to improve families' and caregivers' involvement in the health management of children or young people. Further research with appropriate study designs and longer-term outcome measures should be encouraged. TRIAL REGISTRATION: PROSPERO CRD42016035467; http://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD 42016 035467(Archived by WebCite at http://www.webcitation.org/6vpgZU1FU).

Timely Digital Patient-Clinician Communication in Specialist Clinical Services for Young People: A Mixed-Methods Study (The LYNC Study).

BACKGROUND: Young people (aged 16-24 years) with long-term health conditions can disengage from health services, resulting in poor health outcomes, but clinicians in the UK National Health Service (NHS) are using digital communication to try to improve engagement. Evidence of effectiveness of this digital communication is equivocal. There are gaps in evidence as to how it might work, its cost, and ethical and safety issues. OBJECTIVE: Our objective was to understand how the use of digital communication between young people with long-term conditions and their NHS specialist clinicians changes engagement of the young people with their health care; and to identify costs and necessary safeguards. METHODS: We conducted mixed-methods case studies of 20 NHS specialist clinical teams from across England and Wales and their practice providing care for 13 different long-term physical or mental health conditions. We observed 79 clinical team members and interviewed 165 young people aged 16-24 years with a long-term health condition recruited via case study clinical teams, 173 clinical team members, and 16 information governance specialists from study NHS Trusts. We conducted a thematic analysis of how digital communication works, and analyzed ethics, safety and governance, and annual direct costs. RESULTS: Young people and their clinical teams variously used mobile phone calls, text messages, email, and voice over Internet protocol. Length of clinician use of digital communication varied from 1 to 13 years in 17 case studies, and was being considered in 3. Digital communication enables timely access for young people to the right clinician at the time when it can make a difference to how they manage their health condition. This is valued as an addition to traditional clinic appointments and can engage those otherwise disengaged, particularly at times of change for young people. It can enhance patient autonomy, empowerment and activation. It challenges the nature and boundaries of therapeutic relationships but can improve trust. The clinical teams studied had not themselves formally evaluated the impact of their intervention. Staff time is the main cost driver, but offsetting savings are likely elsewhere in the health service. Risks include increased dependence on clinicians, inadvertent disclosure of confidential information, and communication failures, which are mostly mitigated by young people and clinicians using common-sense approaches. CONCLUSIONS: As NHS policy prompts more widespread use of digital communication to improve the health care experience, our findings suggest that benefit is most likely, and harms are mitigated, when digital communication is used with patients who already have a relationship of trust with the clinical team, and where there is identifiable need for patients to have flexible access, such as when transitioning between services, treatments, or lived context. Clinical teams need a proactive approach to ethics, governance, and patient safety.

Motivational interviewing: relevance in the treatment of rheumatoid arthritis?

Advances in pharmacological treatment options in RA have led to a dramatic potential for improvement in patients' physical and psychological status. Despite advances, poor outcomes, including fatigue, pain, reduced physical activity and quality of life, are still observed. Reasons include non-adherence to medication, insufficient knowledge about the disease and lack of support in coping and effectively self-managing their condition. Motivational interviewing (MI) is a person-centred approach that relies on collaboration and empathy aiming to elicit a person's own motivation for behaviour change. It has been implemented in a variety of long-term conditions, addressing issues such as lifestyle changes with beneficial effects, but it is yet to be widely recognized and adopted in the field of rheumatology. This review will explain the techniques underpinning MI and the rationale for adopting this approach in rheumatology with the aim to increase medication adherence and physical activity and improve patients' coping strategies for pain and fatigue.

Diabetes Distress Among Adolescents with Type 1 Diabetes: a Systematic Review.

Diabetes distress (DD) refers to the negative emotions arising from living with diabetes and the burden of self-management. Among adults, the prevalence and significance of DD are well established, but this is not the case among adolescents. This systematic review investigated among adolescents with type 1 diabetes: the prevalence of DD; demographic, clinical, behavioral and psychosocial correlates of DD and interventions that reduce DD. Consistent with adult studies, around one third of adolescents experience elevated DD and this is frequently associated with suboptimal glycemic control, low self-efficacy and reduced self-care. Three measures of DD have been developed specifically for adolescents, as those designed for adults may not be sufficiently sensitive to adolescent concerns. Interventions reducing DD in the short term include strategies such as cognitive restructuring, goal setting and problem solving. Further work is needed to investigate sustainability of effect. Rigorous research is needed to progress this field among adolescents.

Influences on uptake of cancer screening in mental health service users: a qualitative study.

BACKGROUND: Cancers are a leading cause of death worldwide. People with mental illness are 30 % more likely to die from cancer than the general population. One reason for this may be low uptake of nationally offered cancer screening tests by people with mental illness. We aimed to identify barriers and facilitators for breast, cervical and bowel cancer screening uptake by people with mental illness in order to inform interventions to promote equal access. METHODS: The interview study was conducted in both urban and rural settings. The study was informed by the Theoretical Domains Framework, using framework analysis and triangulation across participant groups. Participants included 45 mental health service users (service users) eligible for cancer screening, 29 mental health professionals and 11 professionals involved in cancer screening. RESULTS: Themes emerging from the data that affected uptake included knowledge of screening programmes by both service users and healthcare providers; knowledge of, and attitudes towards, mental illness; health service-delivery factors; service users' beliefs and concerns about cancer screening, and practical issues. These are relevant to different stages of the screening process. Service users do not receive invitations to screening or cancer testing kits if they are admitted to hospital. They are not routinely invited for screening if they are not registered with a general practitioner (GP). Lack of integrated care means that mental health staff do not know if someone is overdue for a test and cancer screening is often not considered during health promotion. Barriers including information processing problems, the extent to which the screening process aggravates symptoms, poor staff client relationships and travel difficulties vary between individuals. Screening professionals are motivated to help, but may lack time or training to manage mental health needs. Reactive measures are available, but service users must request help which they may find difficult. CONCLUSIONS: There are specific barriers to cancer screening uptake for mental health service users that prevent equality of care. Interventions that can be personalised are needed at individual, policy and service-delivery levels. Primary and secondary care staff and policy-makers should work together to develop an integrated approach to cancer screening in this population.

Identifying disease-specific distress in patients with inflammatory bowel disease.

OBJECTIVES: Inflammatory bowel disease (IBD) imposes a significant burden on patients. The authors have noticed an underlying presence of distress, seemingly distinct from anxiety and depression, in qualitative data collected for previous studies. Disease-related distress has been explored in diabetes, but has not been addressed in IBD. The authors aimed to determine the presence of IBD distress to inform development of a scale for assessing the phenomenon. METHODS: This three-phase study used (1) a conceptual framework based on diabetes distress to conduct secondary analysis of qualitative data from four previous IBD studies (n=49 transcripts). Patient advisors confirmed the themes identified as causing distress, which guided (2) a focus group with people with IBD (n=8) and (3) items generated from phase 1 and 2 were subsequently used for a modified Delphi survey of IBD health professionals. RESULTS: Five IBD-distress themes were identified: emotional distress; healthcare-related distress; interpersonal/social distress; treatment-related distress; and symptom-related distress. DISCUSSION: Disease-specific distress in IBD was identified and is distinct from stress, anxiety and depression. Some causes of IBD distress overlap with diabetes distress, but existing diabetes-distress scales do not explain all the distress experienced by people with IBD and development of a new IBD-distress scale is warranted.

The detection and management of diabetes distress in people with type 1 diabetes.

Diabetes distress (DD) represents a significant clinical burden in which levels of DD are related to both glycated haemoglobin (HbA1c) and some self-management behaviours. DD is related to, but different from, depression. Differences in DD experienced in people with type 1 and type 2 diabetes have been observed. Commonly measured using the Problem Areas in Diabetes Scale (PAID) and the Diabetes Distress Scale (DDS), rates of elevated DD in research study participants range from 20 to 30 %. Risk factors for elevated DD in type 1 diabetes are longer duration of diabetes, severe hypoglycaemia, younger age and being female. A systematic review of intervention studies assessing DD identified eight randomised controlled trials (RCTs) and nine pre-post design studies. Only three studies targeted DD with the intervention. Intervention types were diabetes self-management education (DSME), psychologically informed self-management and devices. DSME pre-post studies, namely the Dose Adjustment For Normal Eating (DAFNE) programme, produced more consistent improvements in DD and HbA1c at follow-up. Psychologically informed self-management was more heterogeneous, but several RCTs were effective in reducing DD. Group interventions offered the greatest benefits across intervention designs.

Improving foot self-care in people with diabetes in Ghana: A development and feasibility randomised trial of a context appropriate, family-orientated diabetic footcare intervention.

OBJECTIVE: Africa presents a higher diabetic foot ulcer prevalence estimate of 7.2% against global figures of 6.3%. Engaging family members in self-care education interventions has been shown to be effective at preventing diabetes-related foot ulcers. This study culturally adapted and tested the feasibility and acceptability of an evidence-based footcare family intervention in Ghana. METHODS: The initial phase of the study involved stakeholder engagement, comprising Patient Public Involvement activities and interviews with key informant nurses and people with diabetes (N = 15). In the second phase, adults at risk of diabetes-related foot ulcers and nominated caregivers (N = 50 dyads) participated in an individually randomised feasibility trial of the adapted intervention (N = 25) compared to usual care (N = 25). The study aimed to assess feasibility outcomes and to identify efficacy signals on clinical outcomes at 12 weeks post randomisation. Patient reported outcomes were foot care behaviour, foot self-care efficacy, diabetes knowledge and caregiver diabetes distress. RESULTS: Adjustments were made to the evidence-based intervention to reflect the literacy, information needs and preferences of stakeholders and to develop a context appropriate diabetic foot self-care intervention. A feasibility trial was then conducted which met all recruitment, retention, data quality and randomisation progression criteria. At 12 weeks post randomisation, efficacy signals favoured the intervention group on improved footcare behaviour, foot self-care efficacy, diabetes knowledge and reduced diabetes distress. Future implementation issues to consider include the staff resources needed to deliver the intervention, family members availability to attend in-person sessions and consideration of remote intervention delivery. CONCLUSION: A contextual family-oriented foot self-care education intervention is feasible, acceptable, and may improve knowledge and self-care with the potential to decrease diabetes-related complications. The education intervention is a strategic approach to improving diabetes care and prevention of foot disease, especially in settings with limited diabetes care resources. Future research will investigate the possibility of remote delivery to better meet patient and staff needs. TRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR) - PACTR202201708421484: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 or pactr.samrc.ac.za/Search.aspx.

Uptake of self-management education programmes for people with type 2 diabetes in primary care through the embedding package: a cluster randomised control trial and ethnographic study.

BACKGROUND: Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. METHODS: Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. 'Embedders' supported practices and self-management programme providers to embed programme referral into routine practice, and an online 'toolkit' contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months - 3-0), step one (months 1-9), step 2 (months 10-18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. RESULTS: No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices' interactions with the toolkit. CONCLUSIONS: Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted. TRIAL REGISTRATION: ISRCTN23474120, registered 05/04/2018.

Bringing an end to diabetes stigma and discrimination: an international consensus statement on evidence and recommendations.

People with diabetes often encounter stigma (ie, negative social judgments, stereotypes, prejudice), which can adversely affect emotional, mental, and physical health; self-care, access to optimal health care; and social and professional opportunities. To accelerate an end to diabetes stigma and discrimination, an international multidisciplinary expert panel (n=51 members, from 18 countries) conducted rapid reviews and participated in a three-round Delphi survey process. We achieved consensus on 25 statements of evidence and 24 statements of recommendations. The consensus is that diabetes stigma is driven primarily by blame, perceptions of burden or sickness, invisibility, and fear or disgust. On average, four in five adults with diabetes experience diabetes stigma and one in five experience discrimination (ie, unfair and prejudicial treatment) due to diabetes, such as in health care, education, and employment. Diabetes stigma and discrimination are harmful, unacceptable, unethical, and counterproductive. Collective leadership is needed to proactively challenge, and bring an end to, diabetes stigma and discrimination. Consequently, we achieved unanimous consensus on a pledge to end diabetes stigma and discrimination.