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SOURCE CITATION: Helmink MAG, Hageman SHJ, Eliasson B, et al. Lifetime and 10-year cardiovascular risk prediction in individuals with type 1 diabetes: the LIFE-T1D model. Diabetes Obes Metab. 2024;26:2229-2238. 38456579.

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In this work we demonstrate a miniaturised imaging system based around a time-gated SPAD array operating in a "chip-on-tip" manner. Two versions of the system are demonstrated, each measuring 23 mm × 23 mm × 28 mm with differing fields of view and working distances. Initial tests demonstrate contrast between materials in widefield fluorescence imaging (WFLIm) mode, with frame rates of > 2 Hz achievable. Following this, WFLIm images of autofluorescence in ovine lung tissue are obtained at frame rates of ~ 1 Hz. Finally, the ability of the second system to perform simultaneous WFLIm and time of flight (aka Flourescence Lifetime Imaging Distance and Ranging, FLImDAR) is also tested. This shows that the system is capable of 4 mm resolution of object separation when tested on 3D printed samples. It is further demonstrated as being able to perform scene reconstruction on autofluorescent lung tissue. This system is, to date, the smallest chip on tip WFLIm system published, and is the first demonstration of the FLImDAR technique in a compact, portable system.

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Time-resolved fibre optic Raman distributed temperature sensing (DTS) measurements experience long measurement times due to a weak backscattered Raman signal inside optical fibres or limited detector count rates. Here, improvements to previous work based on individual detectors are demonstrated using a 512 pixel complementary-metal-oxide semiconductor (CMOS) single-photon avalanche diode (SPAD) line sensor array with integrated (on-chip) timing electronics. Multiplexed single photon counting increases count rate and decreases measurement time for practical applications. This allows temperature to be measured every 0.5 m with 0.7 °C accuracy and a 10 s measurement time using a 13.0 m optical fibre, performance over longer distance is also investigated.

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SOURCE CITATION: Marcotte LM, Deeds S, Wheat C, et al. Automated opt-out vs opt-in patient outreach strategies for breast cancer screening: a randomized clinical trial. JAMA Intern Med. 2023;183:1187-1194. 37695621.

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The COVID-19 pandemic's early stages severely impacted global fisheries, particularly areas heavily reliant on imported food and tourism like the Galapagos Islands, Ecuador. To contain the spread of the virus, a full lockdown was implemented. However, the collapse of the tourism industry precipitated the worst economic crisis in the history of this multiple-use marine protected area. This paper examines the impact of the pandemic's early stages on consumption patterns and seafood security in the Galapagos from consumers' perspective, drawing on online surveys conducted during the lockdown. Our findings revealed pre-existing seafood insecurity across the archipelago, further exacerbated by the pandemic on the least-populated island. Nevertheless, the seafood system displayed moderated resilience to the pandemic's socioeconomic disruptions. A variety of adaptive responses were adopted by Galapagos residents to cope with the lockdown. Consumers modified their seafood consumption habits, while fishers adapted their harvesting and marketing strategies. Such adaptive responses were shaped by the unique socioeconomic characteristics of each inhabited island and the ability of seafood suppliers to shift from a tourism- and export-oriented to a resident- and domestic-oriented market. This transition has created novel opportunities to foster a systemic transformation of the Galapagos seafood system to enhance its resilience against future crises caused by new pandemics, climate change, or other natural and anthropogenic drivers of change.

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In this work a combined fluorescence lifetime and surface topographical imaging system is demonstrated. Based around a 126 × 192 time resolved single photon avalanche diode (SPAD) array operating in time correlated single-photon counting (TCSPC) mode, both the fluorescence lifetime and time of flight (ToF) can be calculated on a pixel by pixel basis. Initial tests on fluorescent samples show it is able to provide 4 mm resolution in distance and 0.4 ns resolution in lifetime. This combined modality has potential biomedical applications such as surgical guidance, endoscopy, and diagnostic imaging. The system is demonstrated on both ovine and human pulmonary tissue samples, where it offers excellent fluorescence lifetime contrast whilst also giving a measure of the distance to the sample surface.

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BACKGROUND: Managing bone defects in non-union surgery remains challenging, especially in cases of large defects exceeding 5 cm in size. Historically, amputation and compound osteosynthesis with a remaining PMMA spacer have been viable and commonly used options. The risk of non-union after fractures varies between 2% and 30% and is dependent on various factors. Autologous bone grafts from the iliac crest are still considered the gold standard but are limited in availability, prompting consideration of artificial grafts. OBJECTIVES: The aims and objectives of the study are as follows: 1. To evaluate the radiological outcome of e.g., the consolidation and thus the stability of the bone (three out of four consolidated cortices/Lane-Sandhu-score of at least 3) by using S53P4-type bioactive glass (BaG) as a substitute material for large-sized bone defects in combination with autologous bone using the RIA technique. 2. To determine noticeable data-points as a base for future studies. METHODS: In our clinic, 13 patients received bioactive glass (BaG) as a substitute in non-union therapy to promote osteoconductive aspects. BaG is a synthetic material composed of sodium, silicate, calcium, and phosphate. The primary endpoint of our study was to evaluate the radiological consolidation of bone after one and two years. To assess bone stabilization, we used a modified Lane-Sandhu score, considering only radiological criteria. A bone was considered stabilized if it achieved a minimum score of 3. For full consolidation (all four cortices consolidated), a minimum score of 4 was required. Each bone defect exceeded 5 cm in length, with an average size of 6.69 ± 1.92 cm. RESULTS: The mean follow-up period for patients without final bone consolidation was 34.25 months, with a standard deviation of 14.57 months, a median of 32.00 months and a range of 33 months. In contrast, patients with a fully consolidated non-union had an average follow-up of 20.11 ± 15.69 months and a range of 45 months. Overall, the mean time from non-union surgery to consolidation for patients who achieved final union was 14.91 ± 6.70 months. After one year, six patients (46.2%) achieved complete bone consolidation according to the Lane-Sandhu score. Three patients (23.1%) displayed evident callus formation with expected stability, while three patients (23.1%) did not develop any callus, and one patient only formed a minimal callus with no expected stability. After two years, 9 out of 13 patients (69.2%) had a score of 4. The remaining four patients (30.8%) without expected stability either did not heal within two years or required a revision during that time. CONCLUSIONS: Bioactive glass (BaG) in combination with autologous bone (RIA) appears to be a suitable filler material for treating extensive non-unions of the femur and tibia. This approach seems to show non-inferiority to treatment with Tricalcium Phosphate (TCP). To ensure the success of this treatment, it is crucial to validate the procedure through a randomized controlled trial (RCT) with a control group using TCP, which would provide higher statistical power and more reliable results.

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In this work a handheld Fluorescent Lifetime IMaging (FLIM) system based on a distally mounted < 2 mm2 128 × 120 single photon avalanche diode (SPAD) array operating over a > 1 m long wired interface is demonstrated. The head of the system is ∼4.5 cm x 4.5 cm x 4.5 cm making it suitable for hand-held ex vivo applications. This is, to the best of the authors' knowledge, the first example of a SPAD array mounted on the distal end of a handheld FLIM system in this manner. All existing systems to date use a fibre to collect and relay fluorescent light to detectors at the proximal end of the system. This has clear potential biological and biomedical applications. To demonstrate this, the system is used to provide contrast between regions of differing tissue composition in ovine kidney samples, and between healthy and stressed or damaged plant leaves. Additionally, FLIM videos are provided showing that frame rates of > 1 Hz are achievable. It is thus an important step in realising an in vivo miniaturized chip-on-tip FLIM endoscopy system.

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SOURCE CITATION: Marcucci M, Painter TW, Conen D, et al; POISE-3 Trial Investigators and Study Groups. Hypotension-avoidance versus hypertension-avoidance strategies in noncardiac surgery: an international randomized controlled trial. Ann Intern Med. 2023;176:605-614. 37094336.

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BACKGROUND: The treatment of large-sized bone defects remains a major challenge in trauma and orthopaedic surgery. Although there are many treatment options, there is still no clear guidance on surgical management, and the influence of defect size on radiological and clinical outcome remains unclear due to the small number of affected patients. The aim of the present study was to determine the influence of defect size on the outcome of atrophic and infected nonunions of the tibia or the femur based on the diamond concept in order to provide recommendations for treatment guidance. PATIENTS AND METHODS: All medical records, surgical reports, laboratory data and radiological images of patients treated surgically for atrophic or infected nonunions of the lower limbs (femur or tibia) between 1 January 2010 and 31 December 2020 were examined. Patients with proximal, diaphyseal or distal nonunions of the femur or tibia who were surgically treated at our institution according to the "diamond concept" and attended our standardised follow-up program were included in a database. Surgical treatment was performed as a one- or two-step procedure, depending on the type of nonunion. Patients with a segmental bone defect ≥5 cm were matched with patients suffering a bone defect <5 cm based on five established criteria. According to our inclusion and exclusion criteria, 70 patients with a bone defect ≥5 cm were suitable for analysis. Two groups were formed by matching: the study group (bone defect ≥5 cm; n = 39) and control group (bone defect <5 cm; n = 39). The study was approved by the local ethics committee (S-262/2017). RESULTS: The mean defect size was 7.13 cm in the study and 2.09 cm in the control group. The chi-square test showed equal consolidation rates between the groups (SG: 53.8%; CG: 66.7%). However, the Kaplan-Meier curve and log-rank test showed a significant difference regarding the mean duration until consolidation was achieved, with an average of 15.95 months in the study and 9.24 months in the control group (α = 0.05, p = 0.001). Linear regression showed a significant increase in consolidation duration with increasing defect size (R2 = 0.121, p = 0.021). Logistic regression modelling showed a significant negative correlation between consolidation rate and revision performance, as well as an increasing number of revisions, prior surgeries and total number of surgeries performed on the limb. Clinical outcomes showed equal full weight bearing of the lower extremity after 5.54 months in the study vs. 4.86 months in the control group (p = 0.267). CONCLUSION: Surprisingly, defect size does not seem to have a significant effect on the consolidation rate and should not be seen as a risk factor. However, for the treatment of large-sized nonunions, the follow-up period should be prolonged up to 24 months, due to the extended time until consolidation will be achieved. This period should also pass before a premature revision with new bone augmentation is performed. In addition, it should be kept in mind that as the number of previous surgeries and revisions increases, the prospects for consolidation decrease and a change in therapeutic approach may be required.

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Purpose: A central aspect of the treatment of non-unions is the filling of bone defects. The quantity of available autologous bone for this purpose is limited. Alternatively, or additionally, bone substitutes may be used. The aim of this retrospective, single-center study including 404 non-unions in 393 patients is to investigate the effect of tricalcium phosphate (TCP) on the healing of non-unions. Furthermore, the influence of gender, age, smoking status, comorbidities, type of surgical procedure, presence of infection, and length of treatment was investigated. Methods: We evaluated three groups of patients. Group 1 received TCP + BG, group 2 received BG alone and group 3 received no augmentation. Bone stability was assessed 1 and 2 years after non-union revision surgery through analysis of radiographs using the Lane Sandhu Score. Scores ≥3 were rated as stable Other influencing factors were collected from the electronic medical record. Results: In 224 non-unions, bone defects were filled with autologous bone and TCP (TCP+BG). In 137 non-unions, bone defects were filled with autologous bone (BG), and in 43 non-unions presenting non-relevant defects, neither autologous bone nor TCP were used (NBG). After 2 years, 72.7% of the TCP+BG patients, 90.1% of the BG patients and 84.4% of the NBG patients achieved a consolidation score ≥3. Advanced age, presence of comorbidities and longer treatment period had a significantly negative effect on consolidation 1 year after surgery. Longer treatment periods also showed a negative significant effect after 2 years. It is notable that larger defects, mainly treated with the combination of autologous bone and TCP, showed similar healing rates to that of smaller defects after 2 years. Conclusion: The combination of TCP and autologous bone-grafts shows good results in the reconstruction of complicated bone-defects, but patience is required since the healing period exceeds 1 year in most patients.

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BACKGROUND: It is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity evaluation and examine fidelity moderators of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster-randomized, controlled trial to test the impact of a Community Health Workers (CHW)-led health coaching intervention to prevent incident type 2 Diabetes Mellitus in New York (NY). METHODS: We applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descriptive statistics and regression models. PC patients with prediabetes receiving care from safety-net patient-centered medical homes (PCMHs) at either, VA NY Harbor or at Bellevue Hospital (BH) were eligible to be randomized into the CHW-led CHORD intervention or usual care. Among 559 patients randomized and enrolled in the intervention group, 79.4% completed the intake survey and were included in the analytic sample for fidelity assessment. Fidelity was measured as coverage, content adherence and frequency of each core component, and the moderators assessed were implementation site and patient activation measure. RESULTS: Content adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to goal setting (77.4% BH vs. 87.7% VA), educational coaching (78.9% BH vs. 88.3% VA), number of successful CHW-patient encounters (6 BH vs 4 VA) and percent of patients receiving all four components (41.1% BH vs. 25.7% VA). CONCLUSIONS: The fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of randomized trials of complex multi-site behavioral interventions. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is NCT03006666 .

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SOURCE CITATION: Andersen-Ranberg NC, Poulsen LM, Perner A, et al. Haloperidol for the treatment of delirium in ICU patients. N Engl J Med. 2022;387:2425-35. 36286254.

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SOURCE CITATION: US Preventive Services Task Force; Mangione CM, Barry MJ, et al. Vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2022;327:2326-33. 35727271.

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SOURCE CITATION: Hodkinson A, Tsimpida D, Kontopantelis E, et al. Comparative effectiveness of statins on non-high density lipoprotein cholesterol in people with diabetes and at risk of cardiovascular disease: systematic review and network meta-analysis. BMJ. 2022;376:e067731. 35331984.

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Research indicates that soluble fms-like tyrosine kinase 1 (sFLT-1) and placental growth factor (PLGF) have diagnostic and prognostic significance for women with preeclampsia. However, sparse research has studied these biomarkers in women with preexisting comorbidities such as chronic hypertension, diabetes mellitus, systemic lupus erythematosus and chronic kidney disease. We undertook a prospective longitudinal cohort study to compare the sFLT-1: PlGF ratio between women with and without comorbidities who did and did not go on to develop preeclampsia. We found that women with comorbidities may develop preeclampsia with a milder elevation in sFLT-1: PlGF than do women without comorbidities. This has clinical and research implications.

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The crisis caused by COVID-19 has profoundly affected human activities around the globe, and the Galapagos Islands are no exception. The impacts on this archipelago include the impairment of tourism and the loss of linkages with the Ecuadorian mainland, which has greatly impacted the local economy. The collapse of the local economy jeopardized livelihoods and food security, given that many impacts affected the food supply chain. During the crisis, the artisanal fishers of the Galapagos showed a high capacity to adapt to the diminishing demand for fish caused by the drastic drop in tourism. We observed that fishers developed strategies and initiatives by shifting roles, from being mainly tourism-oriented providers to becoming local-household food suppliers. This new role of fishers has triggered an important shift in the perception of fishers and fisheries in Galapagos by the local community. The community shifted from perceiving fisheries as a sector opposed to conservation and in conflict with the tourism sector to perceiving fisheries as the protagonist sector, which was securing fresh, high-quality protein for the human community. This study explores the socio-economic impacts and adaptations of COVID-19 on Galapagos' artisanal fisheries based on a mixed methods approach, including the analysis of fisheries datasets, interviews, surveys, and participant observation conducted during and after the lockdown. We illustrate the adaptive mechanisms developed by the sector and explore the changes, including societal perceptions regarding small-scale fisheries in the Galapagos. The research proposes strategies to enhance the Galapagos' economic recovery based on behaviors and traits shown by fishers which are considered potential assets to build-up resilience. Supplementary Information: The online version contains supplementary material available at 10.1007/s40152-022-00268-z.

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SOURCE CITATION: Nazarzadeh M, Bidel Z, Canoy D, et al. Blood pressure lowering and risk of new-onset type 2 diabetes: an individual participant data meta-analysis. Lancet. 2021;398:1803-10. 34774144.

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As the understanding of the pathophysiology of preeclampsia has improved, its diagnostic criteria have evolved. The classical triad of hypertension, edema, and proteinuria has become hypertension and organ dysfunction-renal, hepatic, neurologic, hematological, or uteroplacental. However, the most recent definitions have largely been based off consensus and expert opinion, not primary research. In this review, we explore how the criteria have evolved, particularly through the second half of the 20th and the beginning of the 21st century and offer a critical appraisal of the evidence that has led the criteria to where they stand today. Some key themes are the following: the debate between having a simple and convenient blood pressure cutoff vs a blood pressure cutoff that accounts for influencing factors such as age and weight; whether a uniform blood pressure threshold, a rise in blood pressure, or a combination is most discriminatory; whether existing evidence supports blood pressure and proteinuria thresholds in diagnosing preeclampsia; and whether using flow-charts and decision trees might be more appropriate than a single set of criteria. We also discuss the future of a preeclampsia diagnosis. We challenge the move toward a broad (vs restrictive) diagnosis, arguing instead for criteria that directly relate to the prognosis of preeclampsia and the response to treatments.

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