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

ObjectiveAfrica 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 have been shown as effective in preventing diabetes-related foot ulcers. This study culturally adapted and tested the feasibility and acceptability of an evidence-based footcare family intervention in Ghana.MethodsThe initial phase of the study involved stakeholder engagement, comprising Patient Public Involvement activities and interviews with key informant nurses and persons 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 compared to usual care 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 and caregiver diabetes distress.ResultsAdjustments were made to the evidence-based intervention to reflect the literacy and information needs and preferences of stakeholders, 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 and reduced diabetes distress and diabetes knowledge. Future implementation issues to consider include adequate staff time to deliver the intervention and family members unavailability to attend in-person intervention sessions, with suggestions to consider remote delivery of the intervention. ConclusionA contextual family-oriented foot self-care education 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 using remote delivery to better meet patient and staff needs.<br/

"For someone who's rich, it's not a problem". Insights from Tanzania on diabetes health-seeking and medical pluralism among Dar es Salaam's urban poor

The prevalence of chronic non-communicable disease, such as type 2 diabetes mellitus (T2DM), is rising worldwide. In Africa, T2DM is primarily affecting those living in urban areas and increasingly affecting the poor. Diabetes management among urban poor is an area of research that has received little attention. Based on ethnographic fieldwork in Dar es Salam, the causes and conditions for diabetes management in Tanzania have been examined. In this paper, we focus on the structural context of diabetes services in Tanzania; the current status of biomedical and ethnomedical health care; and health-seeking among people with T2DM. We demonstrate that although Tanzania is actively developing its diabetes services, many people with diabetes and low socioeconomic status are unable to engage continuously in treatment. There are many challenges to be addressed to support people accessing diabetes health care services and improve diabetes management

Delegation of insulin administration to non-registered healthcare workers in community nursing teams: a qualitative study

Aims: To explore stakeholder perspectives on the benefits and/or disadvantages of the delegation of insulin injections to healthcare support workers in community nursing services. Design: Qualitative case study. Methods: Interviews with stakeholders purposively sampled from three case sites in England. Data collection took place between October 2020 and July 2021. A reflexive thematic approach to analysis was adopted. Results: A total of 34 interviews were completed: patients and relatives (n = 7), healthcare support workers (n = 8), registered nurses (n = 10) and senior managers/clinicians (n = 9). Analysis resulted in three themes: (i) Acceptance and confidence, (ii) benefits and (iii) concerns and coping strategies. Delegation was accepted by stakeholders on condition that appropriate training, supervision and governance was in place. Continuing contact between patients and registered nurses, and regular contact between registered nurses and healthcare support workers was deemed essential for clinical safety. Services were reliant on the contribution of healthcare support workers providing insulin injections, particularly during the COVID-19 pandemic. Benefits for service and registered nurses included: flexible team working, increased service capacity and care continuity. Job satisfaction and career development was reported for healthcare support workers. Patients benefit from timely administration, and enhanced relationships with the nursing team. Concerns raised by all stakeholders included potential missed care, remuneration and task shifting. Conclusion: Delegation of insulin injections is acceptable to stakeholders and has many benefits when managed effectively. Impact: Demand for community nursing is increasing. Findings of this study suggest that delegation of insulin administration contributes to improving service capacity. Findings highlight the essential role played by key factors such as appropriate training, competency assessment and teamwork, in developing confidence in delegation among stakeholders. Understanding and supporting these factors can help ensure that practice develops in an acceptable, safe and beneficial way, and informs future development of delegation practice in community settings. Patient or Public Contribution: A service user group was consulted during the design phase prior to grant application and provided comments on draft findings. Two people with diabetes were members of the project advisory group and contributed to the study design, development of interview questions, monitoring study progress and provided feedback on study findings

Diabetes Complications at Presentation and One Year by Glycated Haemoglobin at Diagnosis in a Multiethnic and Diverse Socioeconomic Population: Results from the South London Diabetes Study

Background. WHO&apos;s recommendation of HbA 1c ≥ 48 mmol/mol (6.5%) as diagnostic for type 2 diabetes mellitus (T2DM) was adopted by three UK London boroughs in May 2012. The South London Diabetes (SOUL-D) study has recruited people with newly diagnosed T2DM since 2008. We compared participants diagnosed before May 2012 with HbA 1c &lt; 48 mmol/mol to those with diagnostic HbA 1c ≥ 48 mmol/mol. Methods. A prospective cohort study of newly diagnosed T2DM participants from 96 primary care practices, comparing demographic and biomedical variables between those with diagnostic HbA 1c &lt; 48 mmol/mol or HbA 1c ≥ 48 mmol/mol at recruitment and after one year. Results. Of 1488 participants, 22.8% had diagnostic HbA 1c &lt; 48 mmol/mol. They were older and more likely to be white ( &lt; 0.05). At recruitment and one year, there were no between-group differences in the prevalence of diabetic complications, except that those diagnosed with HbA 1c &lt; 48 mmol/mol had more sensory neuropathy at recruitment ( = 0.039) and, at one year, had new myocardial infarction ( = 0.012) but less microalbuminuria ( = 0.012). Conclusions. Use of HbA 1c ≥ 48 mmol/mol as the sole T2DM diagnostic criterion may miss almost a quarter of those previously diagnosed in South London yet HbA 1c &lt; 48 mmol/mol may not exclude clinically important diabetes

Assessing treatment fidelity and contamination in a cluster randomised controlled trial of motivational interviewing and cognitive behavioural therapy skills in type 2 diabetes.

BACKGROUND: Competencies in psychological techniques delivered by primary care nurses to support diabetes self-management were compared between the intervention and control arms of a cluster randomised controlled trial as part of a process evaluation. The trial was pragmatic and designed to assess effectiveness. This article addresses the question of whether the care that was delivered in the intervention and control trial arms represented high fidelity treatment and attention control, respectively. METHODS: Twenty-three primary care nurses were either trained in motivational interviewing (MI) and cognitive behavioural therapy (CBT) skills or delivered attention control. Nurses' skills in these treatments were evaluated soon after training (treatment arm) and treatment fidelity was assessed after treatment delivery for sessions midway through regimen (both arms) using the Motivational Interviewing Treatment Integrity (MITI) domains and Behaviour Change Counselling Index (BECCI) based on consultations with 151 participants (45% of those who entered the study). The MITI Global Spirit subscale measured demonstration of MI principles: evocation, collaboration, autonomy/support. RESULTS: After training, median MITI MI-Adherence was 86.2% (IQR 76.9-100%) and mean MITI Empathy was 4.09 (SD 1.04). During delivery of treatment, in the intervention arm mean MITI Spirit was 4.03 (SD 1.05), mean Empathy was 4.23 (SD 0.89), and median Percentage Complex Reflections was 53.8% (IQR 40.0-71.4%). In the attention control arm mean Empathy was 3.40 (SD 0.98) and median Percentage Complex Reflections was 55.6% (IQR 41.9-71.4%). CONCLUSIONS: After MI and CBT skills training, detailed assessment showed that nurses had basic competencies in some psychological techniques. There appeared to be some delivery of elements of psychological treatment by nurses in the control arm. This model of training and delivery of MI and CBT skills integrated into routine nursing care to support diabetes self-management in primary care was not associated with high competency levels in all skills. TRIAL REGISTRATION: ISRCTN75776892 ; date registered: 19/05/2010

An integrated primary care-based programme of PRE-Pregnancy cARE to improve pregnancy outcomes in women with type 2 Diabetes (The PREPARED study): protocol for a multi-method study of implementation, system adaptation and performance

Background: The number of women of childbearing age with Type 2 diabetes(T2DM) is increasing, and they now account for > 50% of pregnancies in women with pre-existing diabetes. Diabetes pregnancies without adequate pre-pregnancy care have higher risk for poor outcomes (miscarriages, birth-defects, stillbirths) and are associated with increased complications (caesarean deliveries, macrosomic babies, neonatal intensive-care admissions). The risks and costs of these pregnancies can be reduced with pregnancy preparation (HbA1c, ≤ 6.5%, 5 mg folic acid and stopping potentially harmful medicines). However, 90% of women with T2DM, most of whom are based in primary care, are not adequately prepared for pregnancy. This study will evaluate a programme of primary care-based interventions (decision-support systems; pre-pregnancy care-pathways; pregnancy-awareness resources; professional training; and performance monitoring) to improve pregnancy preparation in women with T2DM. Methods: The study aims to optimise the programme interventions and estimate their impact on pregnancy preparation, pre-pregnancy care uptake and pregnancy outcomes. To evaluate this multimodal intervention, we will use a multi-method research design following Complex Adaptive Systems (CAS) theory, refining the interventions iteratively during the study. Thirty GP practices with ≥ 25 women with T2DM of reproductive age (18–45 years) from two South London boroughs will be exposed to the intervention. This will provide > 750 women with an estimated pregnancy incidence of 80–100 to study. The research involves: a clinical audit of processes and outcomes; a process evaluation informing intervention feasibility, implementation, and behaviour change; and a cost-consequences analysis informing future economic evaluation. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes. Following CAS theory, we will use repeated measurements to monitor intervention impact on pregnancy preparation markers at 4-monthly intervals over 18-months. We will use performance and feasibility data to optimise intervention effects iteratively. The target performance for the intervention is a 30% increase in the proportion of women meeting pre-pregnancy care criteria. Discussion: The primary output will be development of an integrated programme of interventions to improve pregnancy preparation, pre-pregnancy care uptake, and reduce adverse pregnancy outcomes in women with T2DM. We will also develop an implementation plan to support the introduction of the interventions across the NHS

Glycaemic control in people with type 2 diabetes mellitus during and after cancer treatment: A systematic review and meta-analysis

Background Cancer and Diabetes Mellitus (DM) are leading causes of death worldwide and the prevalence of both is escalating. People with co-morbid cancer and DM have increased morbidity and premature mortality compared with cancer patients with no DM. The reasons for this are likely to be multifaceted but will include the impact of hypo/hyperglycaemia and diabetes therapies on cancer treatment and disease progression. A useful step toward addressing this disparity in treatment outcomes is to establish the impact of cancer treatment on diabetes control. Aim The aim of this review is to identify and analyse current evidence reporting glycaemic control (HbA1c) during and after cancer treatment. Methods Systematic searches of published quantitative research relating to comorbid cancer and type 2 diabetes mellitus were conducted using databases, including Medline, Embase, PsychINFO, CINAHL and Web of Science (February 2017). Full text publications were eligible for inclusion if they: were quantitative, published in English language, investigated the effects of cancer treatment on glycaemic control, reported HbA1c (%/mmols/mol) and included adult populations with diabetes. Means, standard deviations and sample sizes were extracted from each paper; missing standard deviations were imputed. The completed datasets were analysed using a random effects model. A mixed-effects analysis was undertaken to calculate mean HbA1c (%/mmols/mol) change over three time periods compared to baseline. Results The available literature exploring glycaemic control post-diagnosis was mixed. There was increased risk of poor glycaemic control during this time if studies of surgical treatment for gastric cancer are excluded, with significant differences between baseline and 12 months (p < 0.001) and baseline and 24 months (p = 0.002). Conclusion We found some evidence to support the contention that glycaemic control during and/or after non-surgical cancer treatment is worsened, and the reasons are not well defined in individual studies. Future studies should consider the reasons why this is the case

Patient Health Questionnaire-9 scores do not accurately estimate depression prevalence: individual participant data meta-analysis.

OBJECTIVES: Depression symptom questionnaires are not for diagnostic classification. Patient Health Questionnaire-9 (PHQ-9) scores ≥10 are nonetheless often used to estimate depression prevalence. We compared PHQ-9 ≥10 prevalence to Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) major depression prevalence and assessed whether an alternative PHQ-9 cutoff could more accurately estimate prevalence. STUDY DESIGN AND SETTING: Individual participant data meta-analysis of datasets comparing PHQ-9 scores to SCID major depression status. RESULTS: A total of 9,242 participants (1,389 SCID major depression cases) from 44 primary studies were included. Pooled PHQ-9 ≥10 prevalence was 24.6% (95% confidence interval [CI]: 20.8%, 28.9%); pooled SCID major depression prevalence was 12.1% (95% CI: 9.6%, 15.2%); and pooled difference was 11.9% (95% CI: 9.3%, 14.6%). The mean study-level PHQ-9 ≥10 to SCID-based prevalence ratio was 2.5 times. PHQ-9 ≥14 and the PHQ-9 diagnostic algorithm provided prevalence closest to SCID major depression prevalence, but study-level prevalence differed from SCID-based prevalence by an average absolute difference of 4.8% for PHQ-9 ≥14 (95% prediction interval: -13.6%, 14.5%) and 5.6% for the PHQ-9 diagnostic algorithm (95% prediction interval: -16.4%, 15.0%). CONCLUSION: PHQ-9 ≥10 substantially overestimates depression prevalence. There is too much heterogeneity to correct statistically in individual studies

Accuracy of Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis

Objective: To determine the accuracy of the Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression. Design: Individual participant data meta-analysis. Data sources: Medline, Medline In-Process and Other Non-Indexed Citations, PsycINFO, and Web of Science (January 2000-February 2015). Inclusion criteria: Eligible studies compared PHQ-9 scores with major depression diagnoses from validated diagnostic interviews. Primary study data and study level data extracted from primary reports were synthesized. For PHQ-9 cut-off scores 5-15, bivariate random effects meta-analysis was used to estimate pooled sensitivity and specificity, separately, among studies that used semistructured diagnostic interviews, which are designed for administration by clinicians; fully structured interviews, which are designed for lay administration; and the Mini International Neuropsychiatric (MINI) diagnostic interviews, a brief fully structured interview. Sensitivity and specificity were examined among participant subgroups and, separately, using meta-regression, considering all subgroup variables in a single model. Results: Data were obtained for 58 of 72 eligible studies (total n=17 357; major depression cases n=2312). Combined sensitivity and specificity was maximized at a cut-off score of 10 or above among studies using a semistructured interview (29 studies, 6725 participants; sensitivity 0.88, 95% confidence interval 0.83 to 0.92; specificity 0.85, 0.82 to 0.88). Across cut-off scores 5-15, sensitivity with semistructured interviews was 5-22% higher than for fully structured interviews (MINI excluded; 14 studies, 7680 participants) and 2-15% higher than for the MINI (15 studies, 2952 participants). Specificity was similar across diagnostic interviews. The PHQ-9 seems to be similarly sensitive but may be less specific for younger patients than for older patients; a cut-off score of 10 or above can be used regardless of age.. Conclusions: PHQ-9 sensitivity compared with semistructured diagnostic interviews was greater than in previous conventional meta-analyses that combined reference standards. A cut-off score of 10 or above maximized combined sensitivity and specificity overall and for subgroups. Registration: PROSPERO CRD42014010673

Probability of major depression diagnostic classification using semi-structured vs. fully structured diagnostic interviews

Background: Different diagnostic interviews are used as reference standards for major depression classification in research. Semi-structured interviews involve clinical judgement, whereas fully structured interviews are completely scripted. The Mini International Neuropsychiatric Interview (MINI), a brief fully structured interview, is also sometimes used. It is not known whether interview method is associated with probability of major depression classification. Aims: To evaluate the association between interview method and odds of major depression classification, controlling for depressive symptom scores and participant characteristics. Method: Data collected for an individual participant data meta-analysis of Patient Health Questionnaire-9 (PHQ-9) diagnostic accuracy were analyzed. Binomial Generalized Linear Mixed Models were fit. Results: 17,158 participants (2,287 major depression cases) from 57 primary studies were analyzed. Among fully structured interviews, odds of major depression were higher for the MINI compared to the Composite International Diagnostic Interview (CIDI) [OR (95% CI) = 2.10 (1.15-3.87)]. Compared to semi-structured interviews, fully structured interviews (MINI excluded) were non-significantly more likely to classify participants with low-level depressive symptoms (PHQ-9 scores 6) as having major depression [OR (95% CI) = 3.13 (0.98-10.00)], similarly likely for moderate-level symptoms (PHQ-9 scores 7-15) [OR (95% CI) = 0.96 (0.56-1.66)], and significantly less likely for high-level symptoms (PHQ-9 scores 16) [OR (95% CI) = 0.50 (0.26-0.97)]. Conclusions: The MINI may identify more depressed cases than the CIDI, and semi- and fully structured interviews may not be interchangeable methods, but these results should be replicated