scholarly journals Effectiveness of a multifaceted prevention programme for melioidosis in diabetics (PREMEL): A stepped-wedge cluster-randomised controlled trial

2021 ◽  
Vol 15 (6) ◽  
pp. e0009060
Author(s):  
Pornpan Suntornsut ◽  
Prapit Teparrukkul ◽  
Gumphol Wongsuvan ◽  
Wipada Chaowagul ◽  
Susan Michie ◽  
...  

Background Melioidosis, an often-fatal infectious disease caused by the environmental Gram-negative bacillus Burkholderia pseudomallei, is endemic in tropical countries. Diabetes mellitus and environmental exposure are important risk factors for melioidosis acquisition. We aim to evaluate the effectiveness of a multifaceted prevention programme for melioidosis in diabetics in northeast Thailand. Methodology/Principal findings From April 2014 to December 2018, we conducted a stepped-wedge cluster-randomized controlled behaviour change trial in 116 primary care units (PCUs) in Ubon Ratchathani province, northeast Thailand. The intervention was a behavioural support group session to help diabetic patients adopt recommended behaviours, including wearing rubber boots and drinking boiled water. We randomly allocated the PCUs to receive the intervention starting in March 2016, 2017 and 2018. All diabetic patients were contacted by phone yearly, and the final follow-up was December 2018. Two primary outcomes were hospital admissions involving infectious diseases and culture-confirmed melioidosis. Of 9,056 diabetics enrolled, 6,544 (72%) received a behavioural support group session. During 38,457 person-years of follow-up, we observed 2,195 (24%) patients having 3,335 hospital admissions involved infectious diseases, 80 (0.8%) melioidosis, and 485 (5%) deaths. In the intention-to-treat analysis, implementation of the intervention was not associated with primary outcomes. In the per-protocol analysis, patients who received a behavioural support group session had lower incidence rates of hospital admissions involving infectious diseases (incidence rate ratio [IRR] 0.89; 95%CI 0.80–0.99, p = 0.03) and of all-cause mortality (IRR 0.54; 95%CI 0.43–0.68, p<0.001). However, the incidence rate of culture-confirmed melioidosis was not significantly lower (IRR 0.96, 95%CI 0.46–1.99, p = 0.66). Conclusions/Significance Clear benefits of this multifaceted prevention programme for melioidosis were not observed. More compelling invitations for the intervention, modification of or addition to the behaviour change techniques used, and more frequent intervention may be needed. Trial registration This trial is registered with ClinicalTrials.gov, number NCT02089152.

2020 ◽  
Author(s):  
Pornpan Suntornsut ◽  
Prapit Teparrukkul ◽  
Gumphol Wongsuvan ◽  
Wipada Chaowagul ◽  
Susan Michie ◽  
...  

ABSTRACTBackgroundMelioidosis, an often-fatal infectious disease caused by the environmental Gram-negative bacillus Burkholderia pseudomallei, is endemic in tropical countries. Diabetes mellitus and environmental exposure are important risk factors for melioidosis acquisition. We aim to evaluate the effectiveness of a multifaceted prevention programme for melioidosis in diabetics in northeast Thailand.Methodology/Principal FindingsFrom April 2014 to December 2018, we conducted a stepped-wedge cluster-randomized controlled behaviour change trial in 116 primary care units (PCUs) in Ubon Ratchathani province, northeast Thailand. The intervention was a behavioural support group session to help diabetic patients adopt recommended behaviours, including wearing rubber boots and drinking boiled water. We randomly allocated the PCUs to receive the intervention starting in March 2016, 2017 and 2018. All diabetic patients were contacted by phone yearly, and the final follow-up was December 2018. Two primary outcomes were hospital admissions involving infectious diseases and culture-confirmed melioidosis. Of 9,056 diabetics enrolled, 6,544 (72%) received a behavioural support group session. During 38,457 person-years of follow-up, we observed 2,195 (24%) patients having 3,335 hospital admissions involved infectious diseases, 80 (0.8%) melioidosis, and 485 (5%) deaths. In the intention-to-treat analysis, implementation of the intervention was not associated with primary outcomes. In the per-protocol analysis, patients who received a behavioural support group session had lower incidence rates of hospital admissions involving infectious diseases (incidence rate ratio [IRR] 0.89; 95%CI 0.80-0.99, p=0.03) and of all-cause mortality (IRR 0.54; 95%CI 0.43-0.68, p<0.001). There was a borderline evidence of a lower incidence rate of overall melioidosis in those who received a behavioural support group session (IRR 0.57; 95%CI 0.31-1.08, p=0.09).Conclusions/SignificanceReceiving the multifaceted prevention programme of melioidosis could reduce the rate of hospital admissions involving infectious diseases and mortality. Policy makers in melioidosis-endemic areas should consider implementing a melioidosis prevention programme in diabetes and continuing evaluation of the effectiveness of the programme.Author summaryMelioidosis, an infectious disease caused by environmental bacterium Burkholderia pseudomallei, is endemic in tropical countries. Diabetes mellitus is the most important risk factor, and routes of infection include skin inoculation, ingestion and inhalation. Prevention guidelines recommend that residents, rice farmers and visitors should wear protective gear such as rubber boots when in direct contact with soil and environmental water, and consume only boiled or bottled water. Here, we conducted a cluster randomized controlled trial to evaluate effectiveness of a multifaceted prevention programme of melioidosis in diabetic patients in northeast Thailand. We enrolled 9,056 diabetic patients in 2014. We randomly allocated primary care units as the unit of randomization to receive the intervention starting in March 2016, 2017 and 2018. All diabetic patients were contacted by phone yearly. We found that diabetic patients who received a behavioural support group session had lower incidence rates of hospital admissions involving infectious diseases and of all-cause mortality. We found a borderline evidence of a lower incidence rate of melioidosis in those who received the intervention. We propose that policy makers in melioidosis-endemic countries should consider implementing a melioidosis prevention programme.


2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0001
Author(s):  
Cole Cheney ◽  
John Femino

Category: Ankle, Diabetes, Lesser Toes, Midfoot/Forefoot Introduction/Purpose: Maximal limb preservation is often the goal in choosing partial foot amputation (PFA) as a treat-ment for diabetic foot infections. Some of these patients will go on to experience multiple hospital admissions, IV antibiotic courses, surgical debridements, re-amputations and other medical compli-cations. This study describes the treatment course of these patients starting at second partial foot amputation and ending at 5 year follow-up. Methods: A retrospective cohort was built from a database of all amputation procedures performed on diabet-ic patients at the University of Iowa Department of Orthopedics from 2000 – 2015. The cohort was evaluated over time frame starting at second PFA (index procedure) and ending at 5 years after in-dex procedure. Of 264 patients who underwent partial foot amputation, 49 experienced two lower extremities PFA between January 2000 and December 2011 (cut-off used to allow minimum of 5 years post-PFA). Demographic data was recorded at index PFA and included surgical dates, laterali-ty, surgery type, diagnoses at time of initial surgery, and death date. A chart review collected in-formation on 5 year post-index PFA incidence of: non-surgical hospitalizations, antibiotic admin-istrations, total contact cast applications, and complications (such as osteomyelitis and acute renal failure). Results: Thirty-two (65%) of the second partial foot amputations (index) were ipsilateral and 17 were con-tralateral to first partial foot amputation (pre-index procedure). Eighteen (37%) of the partial foot amputation patients eventually experienced transtibial / transfemoral amputations in the 5 years fol-lowing index PFA. Eleven (22%) had at least a third partial foot amputation (and as many as 7) dur-ing study period. Sixteen (32%) patients had 17 transtibial / transfemoral amputations within 5 year time frame. 11 of the 17 (65%) TT / TF procedures were ipsilateral to index (second) PFA. Seven (17%) of the patients died. Conclusion: Maximal limb preservation may not be beneficial in all cases, particularly in the case of repeat PFAs. This cohort of repeat PFA patients demonstrated a complicated medical course with long pe-riods of hospitalization, leg immobilization in cast, and home-going antibiotics (requiring PICC). This study suggested that over a 5 year period following second PFA, patients on average experi-enced at least 31 days in TCC, 17 days hospitalized and underwent one additional amputation pro-cedure. These are likely underestimates due to follow-up or outside hospital cares. A large number of patients (18 or 37%) ultimately required higher-level amputation. There is a potential morbidity with PFA that may not be communicated to patients when making these decisions. In this cohort, the average days to second PFA was 360 days. 18 of 49 repeat PFA patients underwent tran-stibial or transfemoral amputation within 5 years of their initial PFA. The morbidity of the interim medical course over 5 years added to the poor quality of life after PFA.


2021 ◽  
Author(s):  
Antonio Sarría-Santamera ◽  
Binur Orazumbekova ◽  
Tilektes Maulenkul ◽  
Alessandro Salustri ◽  
Natalya Glushkova ◽  
...  

Abstract Background and aim: Diabetic patients are at an increased risk for the development of macrovascular complications such as acute myocardial infarction (AMI), stroke and lower-limb amputations (LLA). This study aimed to explore a. the incidence of hospital admission for macrovascular complications (AMI, stroke, and LLA); b. to assess the impact of hospital admission on survival in a large population with diabetes mellitus living in Kazakhstan. Materials and methods: Retrospective observational study using a nationwide anonymized electronic database of 98.469 hospitalized diabetic patients from Kazakhstan between November 2013 and December 2019. The incidence of hospital admissions for AMI, stroke and LLA were obtained to calculate their all-time cumulative incidence, and survival rate at follow-up. Results: The all-time cumulative incidence of hospital admissions was 1.30% for AMI, 1.94% for stroke and 2.94% for LLA. The incidence of macrovascular complications was statistically significantly higher in males compared to females (p-value<0.05). 29.03% of diabetic patients with AMI, 25.16% with stroke and 29.80% with LLA died during the follow-up period. Individuals with AMI had 3.58 (95% CI 3.20; 4.01) times, with stroke 3.86 (95% CI 3.52; 4.24) times and with LLA 3.63 (95% CI 3.38; 3.88) times higher hazard of 6-year death compared to diabetic patients free of these complications. The stratified survival analysis by sex indicated the lower survival in women than in men, and the lower survival in older age groups. Conclusion: The results from this study shows that cumulative incidence of AMI and stroke among diabetic patients admitted in the hospitals in Kazakhstan between 2013-2019 years was similar to the estimates from other countries, but the incidence of LLA was significantly higher in Kazakhstan. Patients with diabetes mellitus (DM) in Kazakhstan are at high risk of excess mortality if they suffer from macro-vascular complications. More research is required to explore the reasons for the high incidence of those complications, in order to propose systematic solutions for lowering the incidence and improve survival.


2018 ◽  
Vol 12 (9) ◽  
pp. e0006765 ◽  
Author(s):  
Pornpan Suntornsut ◽  
Wipada Chaowagul ◽  
Wilasinee Thongklang ◽  
Thidarat Phosri ◽  
Nicholas P. J. Day ◽  
...  

2020 ◽  
Vol 29 (4) ◽  
pp. 508-522
Author(s):  
Clémence Bussière ◽  
Nicolas Sirven ◽  
Thomas Rapp ◽  
Christine Sevilla‐Dedieu

2020 ◽  
Vol 105 (7) ◽  
pp. e2617-e2625 ◽  
Author(s):  
Mario Luca Morieri ◽  
Vera Frison ◽  
Mauro Rigato ◽  
Michele D’Ambrosio ◽  
Federica Tadiotto ◽  
...  

Abstract Context In randomized controlled trials (RCTs) on type 2 diabetes (T2D) patients, the glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-RA) dulaglutide reduced HbA1c and body weight, but generalizability of such findings to real-world T2D patients is challenging. Objective We evaluated effectiveness of dulaglutide in routine clinical practice, especially in subgroups of patient that are underrepresented in RCTs. Design Retrospective multicenter study. Setting Diabetes outpatient clinics. Patients and intervention All consecutive patients who initiated dulaglutide between 2015 and 2018. Main outcome measures Changes in HbA1c and body weight were assessed up to 30 months after baseline. Effectiveness was analyzed in patient subgroups according to: prior use of GLP-1RA, persistence on treatment and dose, age, sex, disease duration, renal function, obesity, cardiovascular disease, or concomitant use of insulin or sulphonylurea. Results From a background population of 83,116 patients, 2084 initiated dulaglutide (15.3% switching from another GLP-1RA), 1307 of whom had at least 1 follow-up visit. Overall, dulaglutide reduced HbA1c by 1.0% and body weight by 2.9 kg at the end of observation. These effects were more pronounced in GLP-1RA-naïve patients and in those with shorter disease duration. Improvement in HbA1c was highly significant and consistent across all subgroups, including those aged ≥ 75 years, nonobese, or with chronic kidney disease. Body weight declined in all subgroups and significantly more with the 1.5-mg versus 0.75-mg dose. Conclusions In real-world T2D patients, effectiveness of dulaglutide on HbA1c and body weight reduction was highly consistent and significant even in subgroups of patients poorly represented in RCTs.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Antonio Leon-Justel ◽  
Jose I. Morgado Garcia-Polavieja ◽  
Ana Isabel Alvarez-Rios ◽  
Francisco Jose Caro Fernandez ◽  
Pedro Agustin Pajaro Merino ◽  
...  

Abstract Background Heart failure (HF) is a major and growing medical and economic problem, with high prevalence and incidence rates worldwide. Cardiac Biomarker is emerging as a novel tool for improving management of patients with HF with a reduced left ventricular ejection fraction (HFrEF). Methods This is a before and after interventional study, that assesses the impact of a personalized follow-up procedure for HF on patient’s outcomes and care associated cost, based on a clinical model of risk stratification and personalized management according to that risk. A total of 192 patients were enrolled and studied before the intervention and again after the intervention. The primary objective was the rate of readmissions, due to a HF. Secondary outcome compared the rate of ED visits and quality of life improvement assessed by the number of patients who had reduced NYHA score. A cost-analysis was also performed on these data. Results Admission rates significantly decreased by 19.8% after the intervention (from 30.2 to 10.4), the total hospital admissions were reduced by 32 (from 78 to 46) and the total length of stay was reduced by 7 days (from 15 to 9 days). The rate of ED visits was reduced by 44% (from 64 to 20). Thirty-one percent of patients had an improved functional class score after the intervention, whereas only 7.8% got worse. The overall cost saving associated with the intervention was € 72,769 per patient (from € 201,189 to € 128,420) and €139,717.65 for the whole group over 1 year. Conclusions A personalized follow-up of HF patients led to important outcome benefits and resulted in cost savings, mainly due to the reduction of patient hospitalization readmissions and a significant reduction of care-associated costs, suggesting that greater attention should be given to this high-risk cohort to minimize the risk of hospitalization readmissions.


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