We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.
To save content items to your account,
please confirm that you agree to abide by our usage policies.
If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account.
Find out more about saving content to .
To save content items to your Kindle, first ensure no-reply@cambridge.org
is added to your Approved Personal Document E-mail List under your Personal Document Settings
on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part
of your Kindle email address below.
Find out more about saving to your Kindle.
Note you can select to save to either the @free.kindle.com or @kindle.com variations.
‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi.
‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.
Previous studies on the association between fruit juice consumption and type 2 diabetes remain controversial, which might be due to heterogeneity in the polygenic risk score (PRS) for type 2 diabetes. We examined the association between fruit juice and type 2 diabetes by PRS for type 2 diabetes. We investigated whether fruit juice influences type 2 diabetes risk differently among individuals with varying genetic risks. Data from the Japan Multi-Institutional Collaborative Cohort (J-MICC) study, a cross-sectional study of 13 769 Japanese individuals was used for our analysis. The primary exposure was the frequency of fruit juice, categorised as do not drink, less than 1 cup per day or more than 1 cup per day. We selected PGS002379, a PRS for type 2 diabetes developed using East Asian populations. The primary outcome was physician-diagnosed type 2 diabetes, reported by participants. The consumption of fruit juice was significantly inversely associated with type 2 diabetes in the group with a high PRS for type 2 diabetes (OR: 0·78, 95 % CI: 0·65, 0·93 for < 1 cup/d and OR: 0·54, 95 % CI: 0·30, 0·96 for > 1/d), but this association was not observed in the low PRS group. Fruit juice consumption was inversely associated with type 2 diabetes, especially in genetically high-risk populations for type 2 diabetes.
The composite dietary antioxidant index (CDAI) has been identified as a critical factor in the pathogenesis of certain inflammatory diseases. The study aimed to investigate the relationship between CDAI and Helicobacter pylori infection using cross-sectional design. In this study, participants from the 1999–2000 National Health and Nutrition Examination Survey were analysed using logistic and Cox regression analyses to assess the associations between H. pylori infection and CDAI, encompassing vitamin A, vitamin C, vitamin E, carotene, Zn, Se and Cu. The results demonstrated a negative correlation between CDAI scores and H. pylori infection, revealing a non-linear relationship between the odds of H. pylori infection and CDAI as a continuous variable. Subsequently, a two-sample Mendelian randomisation study was conducted utilising genome-wide association study summary statistics to explore the causal relationship between antioxidant levels and H. pylori infection. We found that the intake of Cu was a protective factor in the occurrence of H. pylori infection but did not support a causal association between circulating Cu levels and H. pylori infection. The prevalence of H. pylori infection was found to be elevated among individuals of older age, lower education levels, limited socio-economic status, smokers, diabetes and those with hypertension. The study suggests that higher CDAI is linked to decreased odds of H. pylori infection, and further prospective studies are needed to confirm the association. Our findings may have significant implications for the prevention and management of H. pylori-related diseases.
Obesity pathophysiological conditions and obesogenic diet compounds may influence brain function and structure and, ultimately, cognitive processes. Animal models of diet-induced obesity suggest that long-term dietary high fat and/or high sugar may compromise cognitive performance through concomitant peripheral and central disturbances. Some indicated mechanisms underlying this relationship are discussed here: adiposity, dyslipidaemia, inflammatory and oxidative status, insulin resistance, hormonal imbalance, altered gut microbiota and integrity, blood–brain barrier dysfunction, apoptosis/autophagy dysregulation, mitochondrial dysfunction, vascular disturbances, cerebral protein aggregates, impaired neuroplasticity, abnormal neuronal network activity and neuronal loss. Mechanistic insights are vital for identifying potential preventive and therapeutic targets. In this sense, flavonoids have gained attention due to their abundant presence in vegetable and other natural sources, their comparatively negligible adverse effects and their capacity to cross the blood–brain barrier promptly. In recent years, interventions with flavonoid sources have proven to be efficient in restoring cognitive impairment related to obesity. Its modulatory effects occur directly and indirectly into the brain, and three fronts of action are highlighted here: (1) restoring physiological processes altered in obesity; (2) promoting additional neuroprotection to the endogenous system; and (3) improving neuroplasticity mechanisms that improve cognitive performance itself. Therefore, flavonoid consumption is a promising alternative tool for managing brain health and obesity-related cognitive impairment.
The aim of this study is to develop a patient-level model for type 2 diabetes mellitus (T2DM) progression that can estimate the cost-effectiveness of T2DM interventions from prevention to management.
Methods
We developed an individual-level microsimulation model, the Institute of Health Economics Diabetes Model (IHE-DM), that simulates: (i) T2DM progression from normal glucose tolerance (NGT) to T2DM, (ii) the occurrence and timing of eight comorbidities and death, and (iii) the correlated progression of risk factors over time. We report model validation and use a case study to investigate the cost-effectiveness of a hypothetical T2DM prevention program.
Results
The internal validation indicated excellent performance with mean absolute differences between the predicted and observed values for all endpoints of less than 1 percent. External validation results were mixed. The model under-predicted cumulative T2DM incidence in the first 8 years, predicted well from years eight through eleven, and over-predicted from years twelve through fifteen. Our case study estimated an incremental net monetary benefit of CAD 2,701 (USD 2,289) (95% Uncertainty Interval: CAD 1,316 to 4,000 [USD 1,115 to 3,390]) over the 15-year time horizon.
Conclusions
Prominent T2DM models focus on patients with diagnosed T2DM whereas our model simulates progression from NGT to T2DM and incorporates important correlations in the progression of risk factors. These adaptations allow us to evaluate preventative interventions and better capture the long-term impacts, filling an important gap in the evidence base. Our model can be used to inform future funding decisions for T2DM interventions across the care continuum.
This cross-sectional study aimed to investigate the correlation between magnesium consumption and periodontitis in different body mass index (BMI) and waist circumference (WC) groups. 8385 adults who participated in the National Health and Nutrition Examination Survey during 2009–2014 were included. The correlation between dietary magnesium intake and periodontitis was first tested for statistical significance by descriptive statistics and weighted binary logistic regression. Subgroup analysis and interaction tests were performed to investigate whether the association was stable in different BMI and WC groups. There was a statistical difference in magnesium intake between periodontitis and non-periodontitis populations. In model 3, participants with the highest magnesium consumption had an odds ratio of 0.72 (0.57-0.92) for periodontitis compared to those with the lowest magnesium consumption. However, in subgroup analysis, the relationship between magnesium intake and periodontitis remained significant only in the non-general obese (BMI ≤ 30 kg/m2) and non-abdominal obese populations (WC ≤ 102 cm in men and ≤ 88 cm in women). Dietary magnesium intake might decrease the periodontitis prevalence in the American population, and this beneficial periodontal health role of magnesium consumption might only be evident in non-general obese and non-abdominal obese populations.
Comorbidities, which are additional health conditions that occur alongside diabetes, can have a significant effect on blood sugar control. These conditions often complicate the management of diabetes and worsen overall health. Malnutrition, on the other hand, is a common concern for people with diabetes due to difficulties with food intake and metabolism. Proper nutrition is crucial for maintaining general health and effectively managing the disease. However, the extent of comorbidities and malnutrition within this group is not well understood in the study area. A cross-sectional study was conducted at Hawassa governmental hospitals between April and May 2023, involving 422 adult outpatients living with diabetes. The study aimed to evaluate their comorbidities, nutritional status, and associated factors. The required data were collected using structured and semi-structured questionnaires. Bivariate and multivariate logistic regression analyses were conducted using SPSS version 25.0. Undernutrition and concordant comorbidities were prevalent in the study population, occurring at rates of 15.2% and 57.8%, respectively. Additionally, 18.5% of participants were classified as overweight and obese with a BMI greater than 25 kg/m2. Three significant predictors of undernutrition among adult outpatients living with diabetes were identified: alcohol intake (P < 0.05), comorbidities (P < 0.01), and educational status (P < 0.05). Concordant comorbidity was notably common in these patients. It is recommended that the healthcare system consider comorbid conditions when managing diabetes. A longitudinal study is suggested to provide stronger evidence on these findings.
The aim of this descriptive study was to assess diabetes self-management and health care demand procrastination behaviors among earthquake victims with type 2 diabetes.
Methods
The population of the study consisted of earthquake victims with Type 2 diabetes in Hatay, Türkiye. The sample included 202 people with type 2 diabetes who lived in 7 distinct container cities. Data were collected using the Introductory Information Form, Diabetes Self-Management Scale, and Healthcare Demand Procrastination Scale via face-to-face interviews.
Results
Participants’ average score on the diabetes self-management scale was 58.34 ± 9.11. Being under the age of 60, employed, visiting a medical center on their own, having received diabetes education, and owning a glucometer were associated with better diabetes self-management, whereas being illiterate and having difficulty covering diabetes-related expenses were associated with poor diabetes management (P < 0.05). Participants’ average score on the Healthcare Demand Procrastination Scale was 2.35 ± 0.72. Respondents who didn’t have a nearby health care institution, whose diabetes diagnosis duration was between 1-5 years, and who didn’t have a glucometer had significantly higher scores on the Healthcare Demand Procrastination Scale (P < 0.05).
Conclusions
Diabetes self-management among earthquake victims with Type 2 diabetes was low. It was also determined that participants’ health care demand procrastination behaviors were at a moderate level.
The study examined the impact of the Diabetes Prevention and Management programme on dietary tracking, changes in dietary behaviour, glycosylated Hb (HbA1c) and weight loss over 6 months among rural adults with type 2 diabetes and prediabetes. The programme was a health coach (HC)-led, community-based lifestyle intervention.
Design:
The study used an explanatory sequential quantitative and qualitative design to gain insight on participant’s dietary behaviour and macronutrient consumption as well as experience with food tracking. Five of the twenty-two educational sessions focussed on dietary education. Participants were taught strategies for healthy eating and dietary modification. Trained HC delivered the sessions and provided weekly feedback to food journals.
Participants:
Obese adults with type 2 diabetes or prediabetes (n 94) participated in the programme and 56 (66 %) completed dietary tracking (optional) for 6 months. Twenty-two participated in three focus groups.
Results:
Fifty-nine percent consistently completed food journals. At 6 months, average diet self-efficacy and dietary intake improved, and average weight loss was 4·58 (sd 9·14) lbs. Factors associated with weight loss included attendance, consistent dietary tracking, higher HbA1c, diabetes status and energy intake (adjusted R2 = 43·5 %; F = 0·003). Focus group participants reported that the programme improved eating habits. The consistency of dietary tracking was cumbersome yet beneficial for making better choices and was key to being honest.
Conclusions:
Participants who consistently tracked their diet improved dietary self-efficacy and intake over 6 months. This model has the potential to be reproduced in other rural regions of the United States.
This study aimed to identify how frequent poor mental health days, a depressive disorder diagnosis, frequent poor physical health days, or physical inactivity affect annual foot examinations in individuals with diabetes.
Background:
Diabetes mellitus (DM), particularly type 2, is a growing problem in the United States and causes serious health complications such as cardiovascular disease, end-stage renal disease, peripheral neuropathy, foot ulcers, and amputations. There are guidelines in place for the prevention of foot ulcers in individuals with diabetes that are not often followed. Poor mental health and poor physical health often arise from DM and contribute to the development of other complications.
Methods:
We performed a cross-sectional analysis of the 2021 Behavioural Risk Factor Surveillance System dataset to determine the relationship between annual foot examinations and frequent poor mental health days, a depressive disorder diagnosis, frequent poor physical health days, or physical inactivity using a bivariate logistic regression model. The regression model was controlled for age, sex, race/ethnicity, health insurance, level of education, current smoking status, and Body Mass Index (BMI) category.
Findings:
Our results showed that 72.06% of individuals with frequent poor mental health days received a foot check, compared with 76.38% of those without poor mental health days – a statistically significant association (AOR: 1.25; 95% CI: 1.09–1.43). Of those reporting a sedentary lifestyle, 73.15% received a foot check, compared with 77.07% of those who were physically active, which was also statistically significant (AOR: 1.31; 95% CI: 1.14–1.49). Although individuals reporting depressive disorder diagnoses and frequent poor physical health days had lower rates of foot examinations, these results were not statistically significant. To reduce rates of foot ulcers and possible amputations, we recommend the implementation of counselling or support groups, increased mental health screening, educational materials, or exercise classes.
This study was designed to explore the mediating role of serum 25-hydroxyvitamin D (25(OH) D) in Triglyceride–glucose (TyG) index and hypertension (HTN). Study participants were selected from the 2001 to 2018 National Health and Nutrition Examination Survey. Firstly, we estimated the association between TyG index and serum 25(OH)D with HTN using a weighted multivariable logistic regression model and restricted cubic spline. Secondly, we used a generalised additive model to investigate the correlation between TyG index and serum 25(OH)D. Lastly, serum 25(OH)D was investigated as a mediator in the association between TyG index and HTN. There were 14 099 subjects in total. TyG index was positively and linearly associated with HTN risk, while serum 25(OH)D had a U-shaped relationship with the prevalence of HTN. When the serum 25(OH)D levels were lower than 57·464 mmol/l, the prevalence of HTN decreased with the increase of serum 25(OH)D levels. When serum 25(OH)D levels rise above 57·464 mmol/l, the risk of HTN increases rapidly. Based on the U-shaped curve, serum 25(OH)D concentrations were divided into two groups: < 57·464 and ≥57·464 mmol/l. According to the mediation analysis, when serum 25(OH)D levels reached < 57·464 mmol/l, the positive association between the TyG index and incident HTN was increased by 25(OH)D. When serum 25(OH)D levels reached ≥ 57·464 mmol/l, the negative association between the TyG index and incident HTN was increased by 25(OH)D. There was a mediation effect between the TyG index and HTN, which was mediated by 25(OH)D. Therefore, we found that the association between serum 25(OH)D levels and TyG index may influence the prevalence of HTN.
Diabetes is a global health concern, and early identification of high-risk individuals is crucial for preventive interventions. Finnish Diabetes Risk Score (FINDRISC) is a widely accepted non-invasive tool that estimates the 10-year diabetes risk. This study aims to validate the FINDRISC in the Turkish population and develop a specific model using data from a nationwide cohort.
Method:
The study used data of 12249 participants from the Türkiye Chronic Diseases and Risk Factors Survey. Data included sociodemographic variables, lifestyle factors, and anthropometric measurements. Multivariable logistic regression was employed using FINDRISC variables to predict incident type 2 diabetes mellitus (T2DM). Two country-specific models, one incorporating the waist-to-hip ratio (WHR model) and the other waist circumference (WC model), were developed. The least absolute shrinkage and selection operator (LASSO) algorithm was used for variable selection in the final models, and model discrimination indexes were compared.
Results:
The optimal FINDRISC cut-off was 8.5, with an area under the curve (AUC) of 0.76, demonstrating good predictive performance in identifying T2DM cases in the Turkish population. Both WHR and WC models showed similar predictive accuracy (AUC: 0.77). Marital status and education were associated with increased diabetes risk in both country-specific models.
Conclusion:
The study found that the FINDRISC tool is effective in predicting the risk of type 2 diabetes in the Turkish population. Models using WHR and WC showed similar predictive performance to FINDRISC. Sociodemographic factors may play a role in diabetes risk. These findings highlight the need to consider population-specific characteristics when evaluating diabetes risk.
Previous studies have shown that helminth infection protects against the development of diabetes mellitus (DM), possibly related to the hygiene hypothesis. However, studies involving Stronglyoides stercoralis and its possible association with DM are scarce and have shown contradicting results, prompting us to perform this meta-analysis to obtain more precise estimates. Related studies were searched from PubMed, Google Scholar, Science Direct, and Cochrane Library until 1 August 2024. Data on the occurrence of DM in patients positive and negative for S. stercoralis were obtained. All analyses were done using Review Manager 5.4. The initial search yielded a total of 1725 studies, and after thorough screening and exclusion, only five articles involving 2106 participants (536 cases and 1570 controls) were included in the meta-analysis. Heterogeneity was assessed, and outlier studies were excluded using a funnel plot. Results showed a significant association of S. stercoralis infection with DM, suggesting that those with the infection are less likely to develop DM. Overall, the results suggest that S. stercoralis infection may decrease the likelihood of developing DM, potentially supporting the hygiene hypothesis.
Despite the frequent co-occurrence of depression and diabetes, gender differences in their relationship remain unclear.
Aims
This exploratory study examined if gender modifies the association between depressive symptoms, prediabetes and diabetes with cognitive-affective and somatic depressive symptom clusters.
Method
Cross-sectional analyses were conducted on 29 619 participants from the 2007–2018 National Health and Nutrition Examination Survey. Depressive symptoms were measured by the nine-item Patient Health Questionnaire. Multiple logistic regression was used to analyse the relationship between depressive symptoms and diabetes. Multiple linear regression was used to analyse the relationship between depressive symptom clusters and diabetes.
Results
The odds of having depressive symptoms were greater in those with diabetes compared to those without. Similarly, total symptom cluster scores were higher in participants with diabetes. Statistically significant diabetes–gender interactions were found in the cognitive-affective symptom cluster model. Mean cognitive-affective symptom scores were higher for females with diabetes (coefficient = 0.23, CI: 0.10, 0.36, P = 0.001) than males with diabetes (coefficient = −0.05, CI: −0.16, 0.07, P = 0.434) when compared to the non-diabetic groups.
Conclusions
Diabetes was associated with higher cognitive-affective symptom scores in females than in males. Future studies should examine gender differences in causal pathways and how diabetic states interact with gender and influence symptom profiles.
Bell’s palsy is acute facial palsy due to inflammation involving the facial nerve related to infections. Rates have not been noted to differ by ethnicity. We studied the lifetime prevalence in First Nations and all other Manitobans in people with type 2 diabetes mellitus aged 7 and older in 2013–2014 and 2016–2017. We found a crude lifetime prevalence of 9.9% [95% CI 9.4–10.4%] in the First Nations population versus 3.9% [95% CI 3.8–4.0%] in all other Manitobans. It is unknown if there were differences in glycemic control. The increased prevalence was found in all five provincial health regions. This study indicates that ethnicity may be an important risk factor for Bell’s palsy.
West Virginia is a rural state with high rates of type 2 diabetes (T2DM) and prediabetes. The Diabetes Prevention and Management (DPM) program was a health coach (HC)-led, 12-month community-based lifestyle intervention.
Objective:
The study examined the impact of the DPM program on changes in glycosylated hemoglobin (A1C) and weight over twelve months among rural adults with diabetes and prediabetes. Program feasibility and acceptability were also explored.
Methods:
An explanatory sequential quantitative and qualitative one-group study design was used to gain insight into the pre- and 12-month changes to health behavior and clinical outcomes. Trained HCs delivered the educational sessions and provided weekly health coaching feedback. Assessments included demographics, clinical, anthropometric, and qualitative focus groups. Participants included 94 obese adults with diabetes (63%) and prediabetes (37%). Twenty-two participated in three focus groups.
Results:
Average attendance was 13.7 ± 6.1 out of 22 sessions. Mean weight loss was 4.4 ± 11.5 lbs at twelve months and clinical improvement in A1C (0.4%) was noted among T2DM adults. Program retention (82%) was higher among older participants and those with poor glycemic control. While all participants connected to a trained HC, only 72% had regular weekly health coaching. Participants reported overall acceptability and satisfaction with the program and limited barriers to program engagement.
Conclusion:
Our findings suggest that it is feasible to implement an HC-led DPM program in rural communities and improve A1C in T2DM adults. Trained HCs have the potential to be integrated with healthcare teams in rural regions of the United States.
Translational research needs to show value through impact on measures that matter to the public, including health and societal benefits. To this end, the Translational Science Benefits Model (TSBM) identified four categories of impact: Clinical, Community, Economic, and Policy. However, TSBM offers limited guidance on how these areas of impact relate to equity. Central to the structure of our Center for American Indian and Alaska Native Diabetes Translation Research are seven regional, independent Satellite Centers dedicated to community-engaged research. Drawing on our collective experience, we provide empirical evidence about how TSBM applies to equity-focused research that centers community partnerships and recognizes Indigenous knowledge. For this special issue – “Advancing Understanding and Use of Impact Measures in Implementation Science” – our objective is to describe and critically evaluate gaps in the fit of TSBM as an evaluation approach with sensitivity to health equity issues. Accordingly, we suggest refinements to the original TSBM Logic model to add: 1) community representation as an indicator of providing community partners “a seat at the table” across the research life cycle to generate solutions (innovations) that influence equity and to prioritize what to evaluate, and 2) assessments of the representativeness of the measured outcomes and benefits.
This study aimed to assess the association between emotional attitudes towards diabetes, eating behaviour styles and glycaemic control in outpatients with type 2 diabetes.
Design:
Observational study.
Setting:
Endocrinology Division of Hospital de Clínicas de Porto Alegre, Brazil.
Participants:
Ninety-one outpatients diagnosed with type 2 diabetes. Baseline assessments included data on clinical parameters, lifestyle factors, laboratory results, eating behaviour styles and emotional attitudes. All patients received nutritional counseling following diabetes recommendations. A follow-up visit was scheduled approximately 90 days later to evaluate changes in weight, medication dosages and glycated Hb (HbA1c) values. Patients were categorised based on their emotional attitude scores towards diabetes (positive or negative), and their characteristics were compared using appropriate statistical tests.
Results:
At baseline, no differences were observed in the proportion of patients with good glycaemic control, eating behaviour styles and emotional attitudes. However, patients with a positive attitude towards the disease exhibited a significantly better response in glycaemic control compared with the reference group (OR = 3·47; 95 % CI = 1·12, 10·75), after adjusting for diabetes duration, sex and medication effect score. However, when BMI was included in the model, the association did not reach statistical significance. Therefore, these results should be interpreted with caution.
Conclusions:
Patients with a positive attitude towards diabetes showed a greater reduction in HbA1c levels following nutritional counseling. However, baseline BMI could be a potential confounding factor.
To characterise the association between risk of poor glycaemic control and self-reported and area-level food insecurity among adult patients with type 2 diabetes.
Design:
We performed a retrospective, observational analysis of cross-sectional data routinely collected within a health system. Logistic regressions estimated the association between glycaemic control and the dual effect of self-reported and area-level measures of food insecurity.
Setting:
The health system included a network of ambulatory primary and speciality care sites and hospitals in Bronx County, NY.
Participants:
Patients diagnosed with type 2 diabetes who completed a health-related social need (HRSN) assessment between April 2018 and December 2019.
Results:
5500 patients with type 2 diabetes were assessed for HRSN with 7·1 % reporting an unmet food need. Patients with self-reported food needs demonstrated higher odds of having poor glycaemic control compared with those without food needs (adjusted OR (aOR): 1·59, 95 % CI: 1·26, 2·00). However, there was no conclusive evidence that area-level food insecurity alone was a significant predictor of glycaemic control (aOR: 1·15, 95 % CI: 0·96, 1·39). Patients with self-reported food needs residing in food-secure (aOR: 1·83, 95 % CI: 1·22, 2·74) and food-insecure (aOR: 1·72, 95 % CI: 1·25, 2·37) areas showed higher odds of poor glycaemic control than those without self-reported food needs residing in food-secure areas.
Conclusions:
These findings highlight the importance of utilising patient- and area-level social needs data to identify individuals for targeted interventions with increased risk of adverse health outcomes.
To examine the psychosocial impact of the COVID-19 pandemic on patients with a diagnosis of diabetes mellitus (DM).
Methods:
Semi-structured interviews were conducted with 31 individuals with DM attending a diabetes clinic to determine the impact of the COVID-19 restrictions on anxiety and depressive symptoms, social and occupational functioning and quality of life. Anxiety symptoms were correlated with functioning, quality of life and diabetes self-management.
Results:
Likert data demonstrated that social functioning (mean = 5.5, SD = 3.7) and quality of life (mean = 4.1, SD = 3.1) were most impacted by the COVID-19 pandemic. Anxiety symptoms were prevalent with 13 individuals (41.9%) scoring above cut-off scores for the presence of anxiety symptoms based on the Beck Anxiety Inventory. Diabetes self-management was significantly correlated with functioning (r = 0.51, p = 0.006) and inversely correlated with anxiety symptoms (r = −0.51, p = 0.007). A prior history of a depressive or anxiety disorder was associated with significantly increased anxiety symptoms, as well as impaired global functioning (p < 0.01), poorer self-care of diabetes (p = 0.014) and satisfaction with diabetes treatment (p = 0.03).
Conclusions:
The psychological and social impact of COVID-19 restrictions on individuals with DM was significant, with poorer management of diabetes correlated with anxiety symptom severity.
Evidence for necrotising otitis externa (NOE) diagnosis and management is limited, and outcome reporting is heterogeneous. International best practice guidelines were used to develop consensus diagnostic criteria and a core outcome set (COS).
Methods
The study was pre-registered on the Core Outcome Measures in Effectiveness Trials (COMET) database. Systematic literature review identified candidate items. Patient-centred items were identified via a qualitative study. Items and their definitions were refined by multidisciplinary stakeholders in a two-round Delphi exercise and subsequent consensus meeting.
Results
The final COS incorporates 36 items within 12 themes: Signs and symptoms; Pain; Advanced Disease Indicators; Complications; Survival; Antibiotic regimes and side effects; Patient comorbidities; Non-antibiotic treatments; Patient compliance; Duration and cessation of treatment; Relapse and readmission; Multidisciplinary team management.
Consensus diagnostic criteria include 12 items within 6 themes: Signs and symptoms (oedema, otorrhoea, granulation); Pain (otalgia, nocturnal otalgia); Investigations (microbiology [does not have to be positive], histology [malignancy excluded], positive CT and MRI); Persistent symptoms despite local and/or systemic treatment for at least two weeks; At least one risk factor for impaired immune response; Indicators of advanced disease (not obligatory but mut be reported when present at diagnosis). Stakeholders were unanimous that there is no role for secondary, graded, or optional diagnostic items. The consensus meeting identified themes for future research.
Conclusion
The adoption of consensus-defined diagnostic criteria and COS facilitates standardised research reporting and robust data synthesis. Inclusion of patient and professional perspectives ensures best practice stakeholder engagement.