Assessing the feasibility and acceptability of a diabetes-specific nurse-led multicomponent smoking cessation intervention in diabetes education: study protocol for an open-label pragmatic randomised controlled trial.

INTRODUCTION: Smoking cessation is an essential, but often overlooked aspect of diabetes management. Despite the need for tailored smoking cessation support for individuals with diabetes, evidence of effective interventions for this cohort is limited. Additionally, individuals with diabetes do not easily adopt such interventions, resulting in low uptake and abstinence rates. This protocol describes a study that aims to assess the feasibility and acceptability of a unique smoking cessation intervention, based on the best evidence, theory and the needs of individuals with diabetes, among patients and service providers, the diabetes nurse educators. METHODS AND ANALYSIS: This is an open-label pragmatic randomised controlled trial. Between 80 and 100 individuals with type 1 or type 2 diabetes who smoke will be recruited from the diabetes outpatients at the main acute public hospital in Malta, starting in August 2023. Participants will be randomly assigned (1:1 ratio) to the intervention or control arm for 12 weeks. The experimental intervention will consist of three to four smoking cessation behavioural support sessions based on the 5As (Ask, Advise, Assess, Assist and Arrange) algorithm, and a 6-week supply of nicotine replacement therapy. The control intervention will consist of an active referral to the Maltese National Health Service's one-to-one smoking cessation support service, which is based on motivational interviewing. The primary feasibility and acceptability outcomes include the recruitment and participation rates, resources used, problems identified by the nurses, the nurses' perceived challenges and facilitators to implementation and the nurses' and patients' acceptability of the study intervention. Data analyses will be descriptive, with quantitative feasibility and acceptability outcomes reported with 95% confidence intervals. ETHICS AND DISSEMINATION: Ethical clearance was obtained from the Faculty of Health Sciences Research Ethics Committee, University of Malta. The study results will be disseminated through conference presentations and a publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05920096.

Factors that modulate platelet reactivity as measured by 5 assay platforms in 3429 individuals.

Background: Assessment of platelet function is key in diagnosing bleeding disorders and evaluating antiplatelet drug efficacy. However, there is a prevailing "one-size-fits-all" approach in the interpretation of measures of platelet reactivity, with arbitrary cutoffs often derived from healthy volunteer responses. Objectives: Our aim was to compare well-used platelet reactivity assays. Methods: Blood and platelet-rich plasma obtained from the Framingham Heart Study (N = 3429) were assayed using a range of agonists in 5 platelet assays: light transmission aggregometry, Optimul aggregometry, Multiplate impedance aggregometry (Roche Diagnostics), Total Thrombus-Formation Analysis System, and flow cytometry. Using linear mixed-effect models, we determined the contribution of preanalytical and technical factors that modulated platelet reactivity traits. Results: A strong intra-assay correlation of platelet traits was seen in all assays, particularly Multiplate velocity (r = 0.740; ristocetin vs arachidonic acid). In contrast, only moderate interassay correlations were observed (r = 0.375; adenosine diphosphate Optimul Emax vs light transmission aggregometry large area under the curve). As expected, antiplatelet drugs strongly reduced platelet responses, with aspirin use primarily targeting arachidonic acid-induced aggregation, and explained substantial variance (ß = -1.735; P = 4.59 × 10-780; variance proportion = 46.2%) and P2Y12 antagonists blocking adenosine diphosphate responses (ß = -1.612; P = 6.75 × 10-27; variance proportion = 2.1%). Notably, female sex and older age were associated with enhanced platelet reactivity. Fasting status and deviations from standard venipuncture practices did not alter platelet reactivity significantly. Finally, the agonist batch, phlebotomist, and assay technician (more so for assays that require additional sample manipulation) had a moderate to large effect on measured platelet reactivity. Conclusion: Caution must be exercised when extrapolating findings between assays, and the use of standard ranges must be medication-specific and sex-specific at a minimum. Researchers should also consider preanalytical and technical variables when designing experiments and interpreting platelet reactivity measures.

Behavioral Therapy for People With Diabetes Who Smoke: A Scoping Review.

BACKGROUND: Tobacco smoking exacerbates diabetes-related complications; its prevalence is notwithstanding substantial. Persons with diabetes face a number of barriers and challenges to quitting such as multiple lifestyle restrictions; tailored interventions are required for smoking cessation. OBJECTIVE: To identify research on behavioral interventions for smoking cessation in diabetes. METHODS: Studies had to be randomized controlled trials, quasiexperimental or systematic reviews. The behavioral interventions included were: the 5As, Cognitive-Behavioral Therapy, Motivational Interviewing, Contingency Management, Health Coaching and Counselling, as compared to standard care. The outcomes were self-reported and/or biochemically verified smoking cessation. CINAHL Complete, MEDLINE Complete, the Cochrane databases of systematic reviews and randomized controlled trials, PsychInfo and PubMed Central were searched until July, 2023. Keywords used included diabetes, smoking cessation and each of the behavioral interventions included. RESULTS: 1615 papers were identified. Three studies on the 5As/brief advice, 4 on Motivational Intervention and 1 on counseling were retained. The results on the 5As and Motivational Interviewing were conflicting. More intensive interventions appear to be more successful in achieving smoking cessation in smokers with diabetes. CONCLUSIONS: Future research should focus on the continued development and evaluation of structured smoking cessation interventions based on the 5As, Motivational interviewing and Cognitive Behavioral Therapy.

Acceptability measures for evaluating smoking cessation interventions among individuals with diabetes.

Background: The literature indicates that individuals with diabetes do not easily adopt smoking cessation interventions. Given that the success of such interventions depends on patient involvement and attitudes, assessing intervention acceptability, including patient satisfaction and perceived usefulness, is crucial before implementing a smoking cessation intervention. This paper reports the preliminary validation of the satisfaction and perceived usefulness questionnaires for evaluating smoking cessation interventions among individuals with diabetes. Study design: Validity study. Methods: The satisfaction questionnaire contained eight statements while the perceived usefulness questionnaire had fourteen; both rated on a 5-point Likert scale. Content validation involved five tobacco cessation facilitators rating item relevance using a 4-point ordinal rating scale, suggesting improvements. The questionnaires were also translated into Maltese for local use and assessed for translation validity using a similar scale. Unanimous agreement among experts was required for item relevance and equivalence. Thirty-four individuals with type 1 or type 2 diabetes, attending a diabetes-specific smoking cessation intervention, received either the Maltese or English versions of the questionnaires. Internal consistency was measured using Cronbach's alpha. Results: After two rounds of content validation, the experts unanimously agreed on item relevance and conceptual equivalence. Fifteen and sixteen participants completed the Maltese and English versions of the questionnaires, respectively. Both questionnaires' versions were found to have a high internal consistency (>0.8). Conclusions: These findings provide the initial validation of these instruments for assessing the acceptability of smoking cessation interventions among individuals with diabetes. Further validation in different settings using a larger sample is suggested.

Exploring the smoking cessation needs of individuals with diabetes using the Information-Motivation-Behavior Skills model.

INTRODUCTION: Smoking cessation is an important aspect of diabetes management. Despite the increased risk for diabetes complications when smoking, evidence suggests that people living with type 1 and type 2 diabetes are less likely to quit smoking when compared to those without diabetes. Guided by the Information-Motivation-Behavioral Skills model, this study aimed to identify the needs of individuals living with type 1 and type 2 diabetes to quit smoking. METHODS: A qualitative descriptive design was adopted. Semi-structured telephone interviews were held between April and June 2021, with 20 former and current Maltese smokers living with type 1 or type 2 diabetes, recruited from the diabetic clinics within the two main acute public hospitals. The interview transcriptions were analyzed using applied thematic analysis. RESULTS: Individuals with diabetes need more information on the effects of smoking on diabetes to encourage cessation. Preventing diabetic complications was reported as a motivator to quit smoking. However, having diabetes was identified as a challenge to quitting. Participants welcomed the provision of health professional support for quitting smoking, identifying the need to provide smoking cessation support within diabetic clinics. The provision of information on tobacco-associated diabetic complications, by using video messages featuring former smokers' stories was also suggested. CONCLUSIONS: To promote smoking cessation among individuals with diabetes, they need to be informed about how smoking affects their condition. Utilizing video messages featuring real-life stories of former smokers with diabetes who experienced tobacco-associated diabetic complications may be influential. Additionally, providing diabetes-specific intensive smoking cessation support is crucial to help them quit.

A telephone-based smoking cessation intervention for individuals with COVID-19: A randomized controlled feasibility study.

INTRODUCTION: Increasing evidence suggests that a diagnosis of a respiratory health condition, such as COVID-19, can prompt a smoker to quit, providing an opportunity to promote and support smoking cessation. However, mandatory quarantine, because of a COVID-19 infection, may stimulate an increase in smoking, making such efforts seem inappropriate or ineffective. This study aimed to investigate the feasibility of a telephone-based smoking cessation intervention for smokers with COVID-19 in Malta. METHODS: An experimental design with a mixed-methods approach was adopted. Participants (n=80) were recruited from a COVID-19 testing center and equally randomized to the intervention (advised to quit and offered three or four telephone-based smoking cessation support sessions) and control (no intervention) groups. Both groups were asked about their smoking habits at baseline and at follow-up at 1 month and at 3 months. The participants in the intervention group were invited to provide feedback on the intervention using questionnaires and by holding interviews. RESULTS: Participants were recruited at a rate of 74.1% between March and April 2022. Most participants were female (58.8%), with a mean age of 41.6 years who smoked about 13 cigarettes per day. The majority (75%) accepted the offered smoking cessation support, receiving an average of two to three sessions. Findings indicate that the participants were satisfied with the support, finding it useful for attempting to quit. More participants in the intervention group reported a serious quitting attempt and a 7-day point prevalence abstinence at any point during the first month. However, 7-day point prevalence abstinence rates did not differ at the follow-up at 3 months. CONCLUSIONS: The study suggests that providing smoking cessation support to individuals with COVID-19 is feasible and well-received. However, the findings suggest that the intervention's impact may have been brief. Thus, further research is recommended before conducting a conclusive trial.

Effectiveness of intensive stand-alone smoking cessation interventions for individuals with diabetes: A systematic review and intervention component analysis.

INTRODUCTION: Tobacco smoking poses a significant threat to the health of individuals living with diabetes. Intensive stand-alone smoking cessation interventions, such as multiple or long (>20 minutes) behavioral support sessions focused solely on smoking cessation, with or without the use of pharmacotherapy, increase abstinence when compared to brief advice or usual care in the general population. However, there is limited evidence so far for recommending the use of such interventions amongst individuals with diabetes. This study aimed to assess the effectiveness of intensive stand-alone smoking cessation interventions for individuals living with diabetes and to identify their critical features. METHODS: A systematic review design with the addition of a pragmatic intervention component analysis using narrative methods was adopted. The key terms 'diabetes mellitus' and 'smoking cessation' and their synonyms were searched in 15 databases in May 2022. Randomized controlled trials which assessed the effectiveness of intensive stand-alone smoking cessation interventions by comparing them to controls, specifically amongst individuals with diabetes, were included. RESULTS: A total of 15 articles met the inclusion criteria. Generally, the identified studies reported on the delivery of a multi-component behavioral support smoking cessation intervention for individuals with type I and type II diabetes, providing biochemically verified smoking abstinence rates at follow-up at six months. The overall risk-of-bias of most studies was judged to be of some concern. Despite observing inconsistent findings across the identified studies, interventions consisting of three to four sessions, lasting more than 20 min each, were found to be more likely to be associated with smoking cessation success. The additional use of visual aids depicting diabetes-related complications may also be useful. CONCLUSIONS: This review provides evidence-based smoking cessation recommendations for use by individuals with diabetes. Nonetheless, given that the findings of some studies were found to be possibly at risk-of-bias, further research to establish the validity of the provided recommendations is suggested.

Helping smokers with diabetes quit: A scoping review of the interventions utilised, and the challenges and barriers to smoking cessation.

Tobacco smoking is recognised as a priority in diabetes management, yet many individuals with diabetes continue to smoke beyond diagnosis. This paper identifies the most promising smoking cessation strategies by reviewing the literature reporting interventions carried out amongst this study population, and the challenges and barriers to smoking cessation. Stand-alone smoking cessation interventions which included pharmacotherapy were found to be more successful in achieving abstinence than interventions which included smoking cessation as part of a broader intervention for improving diabetes management. Misconceptions about smoking and diabetes management were frequently reported, undervaluing smoking cessation. This emphasizes further the need to inform smokers with diabetes about the link between tobacco use and diabetes complications.

Nodular Histiocytic/Mesothelial Hyperplasia Mimicking Mesenteric Metastasis.

Nodular histiocytic/mesothelial hyperplasia (NHMH) is a rare histologic entity, characterized by localized benign reactive proliferation of histiocytes and mesothelial cells. The presence of this rare entity poses a challenge in differential diagnosis, both in radiological findings and pathological interpretations under certain circumstances, and consequently has been misdiagnosed as malignancy. Here, we report a case of mesenteric NHMH in a patient with colonic mucinous adenocarcinoma. Histology shows numerous large calretinin (+) mesothelial cells mixed with CD68 (+) histiocytes by immunohistochemistry. In contrast to almost all previously reported cases with typical features of histiocytic predominance, the current case of NHMH mainly consists of mesothelial cells with intermixed histiocytes. The findings expand the histologic spectrum of NHMH and contribute to awareness of this entity in the differential diagnosis.

Heterotopic Mesenteric Ossification With Trilineage Hematopoiesis.

Heterotopic ossification (HO) histologically refers to extraskeletal bone formation in non-ossifying tissues, most commonly noted in the extremities, buttocks, abdominal wall, and hip joints. HO developing in the mesentery (heterotopic mesenteric ossification, HMO) is very rare, with fewer than 100 cases reported in the literature. It usually occurs in adult male patients with a history of repeated abdominal trauma. So far, only two cases of HMO have been reported with the development of hematopoietic bone marrow. Here, we report the third case of HMO with true trilineage hematopoiesis in a 66-year-old female with suspicious mesenteric-retained foreign material from prior surgical procedures, including hysterectomy for endometrial adenocarcinoma and multiple repairs for incisional hernia.

Human Intestinal Spirochetosis Incompatible With Dysplastic Adenomatous Epithelium.

Human intestinal spirochetosis (HIS) refers to the colonization of spirochetal bacteria in the human intestinal tract. HIS caused by Brachyspira spp. has been recognized for decades, but their pathological and clinical significance is largely unclear. The coincidence of dysplasia in adenoma or adenocarcinoma and HIS is very rare, and whether spirochetes can colonize on dysplastic epithelium remains controversial. Here, we report a case that showed abrupt abolition of mucosal surface fringe formation on a tubular adenoma (TA) and increased cytoplasmic MUC1 expression in the dysplastic epithelial cells compared with adjacent nondysplastic colonocytes. The findings support the hypothesis that the epithelial colonization of spirochetes is significantly reduced by dysplasia likely due to loss of microvilli, and an increase of epithelial MUC1 expression might contribute to reduced spirochetal colonization in colonic mucosa.

Serotonin-Affecting Antidepressant Use in Relation to Platelet Reactivity.

Depression is an independent risk factor of cardiovascular disease morbidity. Serotonin is a key neurotransmitter in depressive pathology, contained within platelets, and is a weak activator of platelets. Our study assessed the link between platelet reactivity traits, depression, and antidepressant (AD) use in a large population sample. Our study was conducted in the Framingham Heart Study (n = 3,140), and AD use (n = 563) and aspirin use (n = 681) were noted. Depression was measured using the Center for Epidemiological Studies-Depression (CES-D) survey. Platelet reactivity traits were measured across multiple agonists using five distinct assays. We utilized a linear mixed effects model to test associations between platelet traits and depression, adjusting for age, sex, aspirin use, and AD use. Similarly, we analyzed trait associations with any AD use, serotonin-affecting ADs, and norepinephrine-affecting ADs, respectively. There were strong associations with reduced platelet function and AD use, particularly with serotonin-affecting medications. This included lower Optimul epinephrine maximal aggregation (P = 4.87E-13), higher U46619 half maximal effective concentration (P = 9.09E-11), lower light transmission aggregometry (LTA) adenosine diphosphate (ADP) final aggregation (P = 1.03E-05), and higher LTA ADP disaggregation (P = 2.28E-05). We found similar associations with serotonin-affecting ADs in an aspirin-taking subset of our sample. There were no significant associations between platelet traits and depression. In the largest study yet of AD use and platelet function we show that antidepressants, particularly serotonin-affecting ADs, inhibit platelets. We did not find evidence that depressive symptomatology in the absence of medication is associated with altered platelet function. Our results are consistent with AD use leading to platelet serotonin depletions, decreased stability of platelet aggregates, and overall decreased aggregation to multiple agonists, which may be a mechanism by which ADs increase risk of bleeding and decrease risk of thrombosis.

Impact of a nurse-led brief tobacco cessation training program for healthcare professionals.

OBJECTIVE: To assess the impact of a tobacco cessation training program on healthcare professionals' smoking cessation practices, counseling-related opinions, and attitudes about their role in tobacco control. DESIGN: A single group pre- and post-design. SAMPLE: Eligible participants (n = 133) were health professionals who attended a training program between September 2018 and June 2019 at specific training sites in Malta. MEASUREMENTS: An already established questionnaire was used to compare healthcare professionals' practices, opinions, and attitudes before the training program, and at 3-month follow-up. INTERVENTION: A public health nurse-led, 3-hr training intervention addressing tobacco use and tobacco cessation with emphasis on the 5As (Ask, Advise, Assess, Assist and Arrange) framework. RESULTS: Healthcare professionals were favorably disposed towards counseling patients to stop. While participants still found it difficult to get clients to quit and lacked the time to counsel patients, they were more likely to deliver tobacco cessation interventions frequently at follow-up. CONCLUSION: Despite these challenges, this training program was found useful by the participants, who took a more comprehensive approach to address tobacco use. Public health nurses are encouraged to take a leading role in tobacco cessation training initiatives as part of their efforts to improve population health.

Brief tobacco cessation interventions: Practices, opinions, and attitudes of healthcare professionals.

INTRODUCTION: Although brief smoking cessation interventions that follow the 5As algorithm (Ask, Advise, Assess, Assist, Arrange) can trigger smokers to quit, routine delivery remains low in Europe. This study aimed to identify the extent of smoking cessation practices of healthcare professionals interested in tobacco cessation, and their opinions and attitudes. METHODS: A quantitative, cross-sectional survey design was adopted. Healthcare professionals (n=133) who attended one of ten training sessions on brief interventions for smoking cessation, held every month between September 2018 and June 2019 in Malta, were recruited. Univariate logistic regression and non-parametric tests were carried out to identify associations by participants' characteristics. Potential confounders were ruled out following multivariate analyses. RESULTS: Most participants were female nurses who had never smoked. While most professionals reportedly asked (76.3%), advised (83.5%) and assessed (70.5%) patients for cessation, fewer provided assistance (40.9%) and arranged followup (24.2%). Compared to other participants, doctors were more likely to have counselled patients over the previous week. Most professionals were favourably disposed towards counselling patients to quit, however, they claimed they had insufficient time to do so. Although most found it difficult to get clients to quit, former smokers were more likely to disagree when compared to those who never smoked (OR=6.86; 95% CI: 2.17-21.71; p=0.001). CONCLUSIONS: While more initiatives to train healthcare professionals in providing smoking cessation interventions are recommended, lack of sufficient time, being an organisational barrier, requires healthcare management exploration and action. Given that former smokers were more confident in helping patients quit, engaging them in training activities would be of added value.