Selection of criteria for a telemedicine framework for designing, implementing, monitoring and evaluating telemedicine interventions: Validation using a modified Delphi process.

Objectives: The call to scale up telemedicine services globally as part of the digital health transformation lacks an agreed-upon set of constructs to guide the implementation process. A lack of guidance hinders the development, consolidation, sustainability and optimisation of telemedicine services. The study aims to reach consensus among telemedicine experts on a set of implementation constructs to be developed into an evidence-based support tool. Methods: A modified Delphi study was conducted to evaluate a set of evidence-informed telemedicine implementation constructs comprising cores, domains and items. The study evaluated the constructs consisting of five cores: Assessment of the Current Situation, Development of a Telemedicine Strategy, Development of Organisational Changes, Development of a Telemedicine Service, and Monitoring, Evaluation and Optimisation of Telemedicine Implementation; seven domains: Individual Readiness, Organisational Readiness, Clinical, Economic, Technological and Infrastructure, Regulation, and Monitoring, Evaluation and Optimisation; divided into 53 items. Global telemedicine specialists (n = 247) were invited to participate and evaluate 58 questions. Consensus was set at ≥70%. Results: Forty-five experts completed the survey. Consensus was reached on 78% of the constructs evaluated. Regarding the core constructs, Monitoring, Evaluation and Optimisation of Telemedicine Implementation was determined to be the most important one, and Development of a Telemedicine Strategy the least. As for the domains, the Clinical one had the highest level of consensus, and the Economic one had the lowest. Conclusions: This research advances the field of telemedicine, providing expert consensus on a set of implementation constructs. The findings also highlight considerable divergence in expert opinion on the constructs of reimbursement and incentive mechanisms, resistance to change, and telemedicine champions. The lack of agreement on these constructs warrants attention and may partly explain the barriers that telemedicine services continue to face in the implementation process.

Unveiling the role of hydroxyapatite and hydroxyapatite/silver composite in osteoblast-like cell mineralization: An exploration through their viscoelastic properties.

Mechanical properties are becoming fundamental for advancing the comprehension of cellular processes. This study addresses the relationship between viscoelastic properties and the cellular mineralization process. Osteoblast-like cells treated with an osteogenic medium were employed for this purpose. Additionally, the study explores the impact of hydroxyapatite (HA) and hydroxyapatite/silver (HA/Ag) composite on this process. AFM relaxation experiments were conducted to extract viscoelastic parameters using the Fractional Zener (FZ) and Fractional Kelvin (FK) models. Our findings revealed that the main phases of mineralization are associated with alterations in the viscoelastic properties of osteoblast-like cells. Furthermore, HA and HA/Ag treatments significantly influenced changes in the viscoelastic properties of these cells. In particular, the HA/Ag treatment demonstrated a marked enhancement in cell fluidity, suggesting a possible role of silver in accelerating the mineralization process. Moreover, the study underscores the independence observed between fluidity and stiffness, indicating that modifications in one parameter may not necessarily correspond to changes in the other. These findings shed light on the factors involved in the cellular mineralization process and emphasize the importance of using viscoelastic properties to discern the impact of treatments on cells.

Bronchioalveolar organoids: A preclinical tool to screen toxicity associated with antibody-drug conjugates.

Despite extensive preclinical testing, cancer therapeutics can result in unanticipated toxicity to non-tumor tissue in patients. These toxicities may pass undetected in preclinical experiments due to modeling limitations involving poor biomimicry of 2-dimensional in vitro cell cultures and due to lack of interspecies translatability in in vivo studies. Instead, primary cells can be grown into miniature 3-dimensional structures that recapitulate morphological and functional aspects of native tissue, termed "organoids." Here, human bronchioalveolar organoids grown from primary alveolar epithelial cells were employed to model lung epithelium and investigate off-target toxicities associated with antibody-drug conjugates (ADCs). ADCs with three different linker-payload combinations (mafodotin, vedotin, and deruxtecan) were tested in bronchioalveolar organoids generated from human, rat, and nonhuman primate lung cells. Organoids demonstrated antibody uptake and changes in viability in response to ADC exposure that model in vivo drug sensitivity. RNA sequencing identified inflammatory activation in bronchioalveolar cells in response to deruxtecan. Future studies will explore specific cell populations involved in interstitial lung disease and incorporate immune cells to the culture.

The Molecular Profile of Soil Microbial Communities Inhabiting a Cambrian Host Rock.

The process of soil genesis unfolds as pioneering microbial communities colonize mineral substrates, enriching them with biomolecules released from bedrock. The resultant intricate surface units emerge from a complex interplay among microbiota and plant communities. Under these conditions, host rocks undergo initial weathering through microbial activity, rendering them far from pristine and challenging the quest for biomarkers in ancient sedimentary rocks. In addressing this challenge, a comprehensive analysis utilizing Gas Chromatography Mass Spectrometry (GC-MS) and Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS) was conducted on a 520-Ma-old Cambrian rock. This investigation revealed a diverse molecular assemblage with comprising alkanols, sterols, fatty acids, glycerolipids, wax esters, and nitrogen-bearing compounds. Notably, elevated levels of bacterial C16, C18 and C14 fatty acids, iso and anteiso methyl-branched fatty acids, as well as fungal sterols, long-chained fatty acids, and alcohols, consistently align with a consortium of bacteria and fungi accessing complex organic matter within a soil-type ecosystem. The prominence of bacterial and fungal lipids alongside maturity indicators denotes derivation from heterotrophic activity rather than ancient preservation or marine sources. Moreover, the identification of long-chain (>C22) n-alkanols, even-carbon-numbered long chain (>C20) fatty acids, and campesterol, as well as stigmastanol, provides confirmation of plant residue inputs. Furthermore, findings highlight the ability of contemporary soil microbiota to inhabit rocky substrates actively, requiring strict contamination controls when evaluating ancient molecular biosignatures or extraterrestrial materials collected.

Reliable Tilt-depth estimates based on the stable computation of the tilt angle using robust vertical derivatives.

The Tilt-depth is a popular approach for determining depths of magnetic sources. As this method is based on the distance between contour levels of the tilt angle, it can lead to inaccurate depth estimates when the contour lines are distorted by the presence of noise. In this paper, we stabilize the Tilt-depth method based on the computation of stable vertical derivative obtained by the ß-VDR method. The presented method is demonstrated on synthetic magnetic anomalies and real magnetic data from the Arabian Shield. The results obtained from the synthetic examples coincide well with the actual depths. These results proved the utility of the presented method in cases where the field is corrupted by noise. The real example shows that the presented method can provide valuable information on subsurface structures of the area where the Tilt-depth estimates are consistent with the result of the horizontal tilt angle. The findings show that the presented method is less sensitive to noise and can provide source edges and depths more clearly and with higher accuracy.

The cardiomyopathy of cystic fibrosis: a modern form of Keshan disease.

Introduction: We conducted a study to determine the prevalence of structural heart disease in patients with CF, the characteristics of a cardiomyopathy not previously described in this population, and its possible relationship with nutritional deficiencies in CF. Methods: We studied 3 CMP CF patients referred for heart-lung transplantation and a prospective series of 120 adult CF patients. All patients underwent a clinical examination, blood tests including levels of vitamins and trace elements, and echocardiography with evaluation of myocardial strain. Cardiac magnetic resonance imaging (CMR) was performed in patients with CMP and in a control group. Histopathological study was performed on hearts obtained in transplant or necropsy. Results: We found a prevalence of 10% (CI 4.6%-15.4%) of left ventricular (LV) dysfunction in the prospective cohort. Myocardial strain parameters were already altered in CF patients with otherwise normal hearts. Histopathological examination of 4 hearts from CF CMP patients showed a unique histological pattern of multifocal myocardial fibrosis similar to Keshan disease. Four of the five CF CMP patients undergoing CMR showed late gadolinium uptake, with a characteristic patchy pattern in 3 cases (p < 0.001 vs. CF controls). Selenium deficiency (Se < 60 µg/L) was associated with more severe LV dysfunction, higher prevalence of CF CMP, higher NTproBNP levels, and more severe pulmonary and digestive involvement. Conclusion: 10% of adults with CF showed significant cardiac involvement, with histological and imaging features resembling Keshan disease. Selenium deficiency was associated with the presence and severity of LV dysfunction in these patients.

Reverse Ishiguro Extension Block Technique as an Alternative for Irreducible Osseous Mallet Finger.

Subacute or late-presenting unstable osseous mallet finger might be hard to reduce and, therefore, remain subluxed when using the traditional Ishiguro technique. In such cases, we suggest it is best to prioritize correction of joint subluxation over step-by-step adherence to the traditional Ishiguro technique. Specifically, we contend that carrying out the procedure in reverse order typically results in an easier and more stable reduction of both joint and fracture.

Role of palliative care intervention in patients with vulvar cancer: a retrospective study.

OBJECTIVE: To describe the experience of a Mexican cancer centre in vulvar cancer and the opportunity to incorporate palliative care (PC) during treatment. PATIENTS AND METHODS: A retrospective study of clinical and sociodemographic characteristics of women with vulvar cancer referred to the PC service (PCS) between 2010 and 2021 is reported. Frequencies were estimated, as well as medians and IQRs, accordingly. Referral time and overall survival were estimated using the Kaplan-Meier method. RESULTS: 125 women with vulvar cancer were seen between 2010 and 2021, but only 42% were seen at PCS, mostly polysymptomatic, after several visits to the emergency room. 89% of the patients seen at PCS died at home. CONCLUSIONS: Vulvar cancer is a rare type of cancer, while squamous cell carcinoma is the most frequent type. At the time of referral, almost half of the patients had severe pain, bleeding, malodor, infection and urinary incontinence. Most of these patients lived in poverty, were poorly educated and had multiple surgeries. PC may play an important role in the care of patients with advanced vulvar cancer, relieving the physical and psychological symptoms, avoiding unnecessary hospitalisation and favouring death at home without pain and other symptoms.

Unraveling plant-pollinator interactions from a south-west Andean forest in Colombia.

Background: Loss of biological connectivity increases the vulnerability of ecological dynamics, thereby affecting processes such as pollination. Therefore, it is important to understand the roles of the actors that participate in these interaction networks. Nonetheless, there is a significant oversight regarding the main actors in the pollination networks within the highly biodiverse forests of Colombia. Hence, the present study aims to evaluate the interaction patterns of a network of potential pollinators that inhabit an Andean Forest in Totoró, Cauca, Colombia. Methods: The interactions between plants and potential pollinators were recorded through direct observation in 10 transects during six field trips conducted over the course of one year. Subsequently, an interaction matrix was developed, and network metrics such as connectance, specialization, nestedness, and asymmetry of interaction strength were evaluated by applying null models. An interpolation/extrapolation curve was calculated in order to assess the representativeness of the sample. Finally, the key species of the network were identified by considering degree (k), centrality, and betweenness centrality. Results: A total of 53 plant species and 52 potential pollinator species (including insects and birds) were recorded, with a sample coverage of 88.5%. Connectance (C = 0.19) and specialization (H2' = 0.19) were low, indicating a generalist network. Freziera canescens, Gaiadendron punctatum, Persea mutisii, Bombus rubicundus, Heliangelus exortis, Chironomus sp., and Metallura tyrianthina were identified as the key species that contribute to a more cohesive network structure. Discussion: The present study characterized the structure of the plant-pollinator network in a highly diverse Andean forest in Colombia. It is evident that insects are the largest group of pollinators; however, it is interesting to note that birds form a different module that specializes in pollinating a specific group of plants. On the other hand, the diversity and generality of the species found suggest that the network may be robust against chains of extinction. Nevertheless, the presence of certain introduced species, such as Apis mellifera, and the rapid changes in vegetation cover may affect the dynamics of this mutualistic network. So, it is imperative to apply restoration and conservation strategies to these ecosystems in order to enhance plant-animal interactions and prevent the loss of taxonomical and functional diversity.

Development of the Biomech-Wrist: A 3-DOF Exoskeleton for Rehabilitation and Training of Human Wrist.

This work describes a three-degrees-of-freedom rehabilitation exoskeleton robot for wrist articulation movement: the Biomech-Wrist. The proposed development includes the design requirements based on the biomechanics and anthropometric features of the upper limb, the mechanical design, electronic instrumentation, software design, manufacturing, control algorithm implementation, and the experimental setup to validate the functionality of the system. The design requirements were set to achieve human wrist-like movements: ulnar-radial deviation, flexion-extension, and pronation-supination. Then, the mechanical design considers the human range of motion with proper torques, velocities, and geometry. The manufacturing consists of 3D-printed elements and tubular aluminum sections resulting in lightweight components with modifiable distances. The central aspect of the instrumentation is the actuation system consisting of three brushless motors and a microcontroller for the control implementation. The proposed device was evaluated by considering two control schemes to regulate the trajectory tracking on each joint. The first scheme was the conventional proportional-derivative controller, whereas the second was proposed as a first-order sliding mode. The results show that the Biomech-Wrist exoskeleton can perform trajectory tracking with high precision ( RMSEmax = 0.0556 rad) when implementing the sliding mode controller.

Knowledge management tools and mechanisms for evidence-informed decision-making in the WHO European Region: a scoping review.

BACKGROUND: Knowledge management (KM) emerged as a strategy to promote evidence-informed decision-making. This scoping review aims to map existing KM tools and mechanisms used to promote evidence-informed health decision-making in the WHO European Region and identify knowledge gaps. METHODS: Following the Joanna Briggs Institute (JBI) guidance for conducting scoping reviews, we searched Medline, PubMed, EMBASE, the Cochrane library, and Open Grey. We conducted a descriptive analysis of the general characteristics of the included papers and conducted narrative analysis of the included studies and categorized studies according to KM type and phase. RESULTS: Out of 9541 citations identified, we included 141 studies. The KM tools mostly assessed are evidence networks, surveillance tools, observatories, data platforms and registries, with most examining KM tools in high-income countries of the WHO European region. Findings suggest that KM tools can identify health problems, inform health planning and resource allocation, increase the use of evidence by policymakers and stimulate policy discussion. CONCLUSION: Policymakers and funding agencies are called to support capacity-building activities, and future studies to strengthen KM in the WHO European region particularly in Eastern Europe and Central Asia. An updated over-arching strategy to coordinate KM activities in the WHO European region will be useful in these efforts.

Dog and Cat Bites: Rapid Evidence Review.

Animal bites are a significant burden to health care systems worldwide. In the United States, dog bites account for an average of 337,000 emergency visits and generate medical costs of up to $2 billion per year. Most animal bites in adults and children are from a dog, and most bite patients are children who have been bitten by animals known to them. Dog bites may cause crush and soft-tissue avulsion, whereas cat bites usually cause deeper puncture-type wounds. Children most often present with dog bites on the head and neck, and adolescents and adults usually present with dog bites on the extremities and hands. Bite wounds should be examined, cleaned, and irrigated with warm water or normal saline solution, and any foreign bodies and devitalized tissue should be removed. Neurovascular function (e.g., pulses, sensation) and range and movement of adjacent joints should be examined and documented. Antibiotic prophylaxis, with amoxicillin/clavulanate as the first-line choice, should be considered for all bites, particularly for those at increased risk of infection. Imaging and laboratory studies are usually not required unless there is suspicion of a retained foreign body, damage to underlying structures, infection, or extensive injury. Primary closure of bite wounds may be performed if there is low risk of infection. The need for tetanus vaccination and rabies postexposure prophylaxis should be evaluated for each patient; bites that do not break the skin generally do not require rabies postexposure prophylaxis.

Radiomics Analyses to Predict Histopathology in Patients with Metastatic Testicular Germ Cell Tumors before Post-Chemotherapy Retroperitoneal Lymph Node Dissection.

BACKGROUND: The identification of histopathology in metastatic non-seminomatous testicular germ cell tumors (TGCT) before post-chemotherapy retroperitoneal lymph node dissection (PC-RPLND) holds significant potential to reduce treatment-related morbidity in young patients, addressing an important survivorship concern. AIM: To explore this possibility, we conducted a study investigating the role of computed tomography (CT) radiomics models that integrate clinical predictors, enabling personalized prediction of histopathology in metastatic non-seminomatous TGCT patients prior to PC-RPLND. In this retrospective study, we included a cohort of 122 patients. METHODS: Using dedicated radiomics software, we segmented the targets and extracted quantitative features from the CT images. Subsequently, we employed feature selection techniques and developed radiomics-based machine learning models to predict histological subtypes. To ensure the robustness of our procedure, we implemented a 5-fold cross-validation approach. When evaluating the models' performance, we measured metrics such as the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, precision, and F-score. RESULT: Our radiomics model based on the Support Vector Machine achieved an optimal average AUC of 0.945. CONCLUSIONS: The presented CT-based radiomics model can potentially serve as a non-invasive tool to predict histopathological outcomes, differentiating among fibrosis/necrosis, teratoma, and viable tumor in metastatic non-seminomatous TGCT before PC-RPLND. It has the potential to be considered a promising tool to mitigate the risk of over- or under-treatment in young patients, although multi-center validation is critical to confirm the clinical utility of the proposed radiomics workflow.

Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping.

BACKGROUND: The adoption of digital health care within health systems is determined by various factors, including pricing and reimbursement. The reimbursement landscape for digital health in Europe remains underresearched. Although various emergency reimbursement decisions were made during the COVID-19 pandemic to enable health care delivery through videoconferencing and asynchronous care (eg, digital apps), research so far has primarily focused on the policy innovations that facilitated this outside of Europe. OBJECTIVE: This study examines the digital health reimbursement strategies in 8 European countries (Belgium, France, Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom) and Israel. METHODS: We mapped available digital health reimbursement strategies using a scoping review and policy mapping framework. We reviewed the literature on the MEDLINE, Embase, Global Health, and Web of Science databases. Supplementary records were identified through Google Scholar and country experts. RESULTS: Our search strategy yielded a total of 1559 records, of which 40 (2.57%) were ultimately included in this study. As of August 2023, digital health solutions are reimbursable to some extent in all studied countries except Poland, although the mechanism of reimbursement differs significantly across countries. At the time of writing, the pricing of digital health solutions was mostly determined through discussions between national or regional committees and the manufacturers of digital health solutions in the absence of value-based assessment mechanisms. Financing digital health solutions outside traditional reimbursement schemes was possible in all studied countries except Poland and typically occurs via health innovation or digital health-specific funding schemes. European countries have value-based pricing frameworks that range from nonexistent to embryonic. CONCLUSIONS: Studied countries show divergent approaches to the reimbursement of digital health solutions. These differences may complicate the ability of patients to seek cross-country health care in another country, even if a digital health app is available in both countries. Furthermore, the fragmented environment will present challenges for developers of such solutions, as they look to expand their impact across countries and health systems. An increased emphasis on developing a clear conceptualization of digital health, as well as value-based pricing and reimbursement mechanisms, is needed for the sustainable integration of digital health. This study can therein serve as a basis for further, more detailed research as the field of digital health reimbursement evolves.

Barriers and facilitators to utilizing digital health technologies by healthcare professionals.

Digital technologies change the healthcare environment, with several studies suggesting barriers and facilitators to using digital interventions by healthcare professionals (HPs). We consolidated the evidence from existing systematic reviews mentioning barriers and facilitators for the use of digital health technologies by HP. Electronic searches were performed in five databases (Cochrane Database of Systematic Reviews, Embase®, Epistemonikos, MEDLINE®, and Scopus) from inception to March 2023. We included reviews that reported barriers or facilitators factors to use technology solutions among HP. We performed data abstraction, methodological assessment, and certainty of the evidence appraisal by at least two authors. Overall, we included 108 reviews involving physicians, pharmacists, and nurses were included. High-quality evidence suggested that infrastructure and technical barriers (Relative Frequency Occurrence [RFO] 6.4% [95% CI 2.9-14.1]), psychological and personal issues (RFO 5.3% [95% CI 2.2-12.7]), and concerns of increasing working hours or workload (RFO 3.9% [95% CI 1.5-10.1]) were common concerns reported by HPs. Likewise, high-quality evidence supports that training/educational programs, multisector incentives, and the perception of technology effectiveness facilitate the adoption of digital technologies by HPs (RFO 3.8% [95% CI 1.8-7.9]). Our findings showed that infrastructure and technical issues, psychological barriers, and workload-related concerns are relevant barriers to comprehensively and holistically adopting digital health technologies by HPs. Conversely, deploying training, evaluating HP's perception of usefulness and willingness to use, and multi-stakeholders incentives are vital enablers to enhance the HP adoption of digital interventions.

Factors associated with emergency room readmission after elective surgery for ovarian carcinoma.

BACKGROUND: Hospital readmission is a quality metric of hospital care and has been studied in ovarian carcinoma, but its evaluation has several limitations. Also, emergency room (ER) readmission is considered an adverse effect because it represents patient costs. Therefore, our objective was to determine the rate of ER readmission, its causes, and associated factors. METHODS: A retrospective study of 592 patients with ovarian carcinoma who underwent upfront surgery, neoadjuvant therapy, or surgery for recurrent disease. An analysis of factors associated with ER readmission, hospital readmission, and surgical complications was performed, including multivariate analysis to assess for case-mix factors. RESULTS: Of 592 patients, the median age was 51 years, and the predominant type of treatment was the neoadjuvant approach (52.9%); 46% underwent upfront surgeries and six surgeries for recurrence. The ratio to ER readmission was 11.8% (70 patients), of whom 12 patients were admitted more than once. The factors associated with ER readmission were prolonged surgery, intraoperative bleeding, extended hospital stay, the time of the day when the surgery was performed, and post-surgical complications. The hospital readmissions were 4.2%, and the overall morbidity was 17.6%. In the multivariate analysis, the only factor associated with ER readmission was the presence of surgical complications (OR = 39.01). The factors independently associated with hospital readmission were the entrance to the intensive care unit (OR = 1.37), the presence of surgical complications (OR = 2.85), and ER readmission (OR = 1.45). CONCLUSION: ER readmission is an adverse event representing the presence of symptoms/complications in patients. Evaluating the ER readmission independently of the readmission to the hospital is critical because it will allow modifying medical care behaviors to prevent patients from unnecessarily returning to the hospital after a hospital discharge to manage preventable medical problems. TRIAL REGISTRATION: researchregistry7882.

Anomalous venoatrial connections - CT and MRI assessment.

Abnormal venous atrial (VA) connections present a congenital heart disease (CHD) challenge for pediatric cardiologists. Fully anatomical evaluation is very difficult in prenatal and perinatal follow-up, but it has a profound impact on surgical correction and outcome. The echocardiogram is first-line imaging and represents the gold standard tool for simple abnormal VA connection. CT and MRI are mandatory for more complex heart disease and "nightmare cases". 3D post-processing of volumetric CT and MRI acquisition helps to clarify anatomical relationships and allows for the creation of 3D printing models that can become crucial in customizing surgical strategy. Our article describes a ten-year (2013-2022) tertiary referral CHD center of abnormal AV connections investigated with CT and MRI, illustrating most of these complex diseases with the help of volume rendering (VR) or multiplanar reconstructions (MPR). The nightmarish cases will also be addressed due to the complex cardiovascular arrangement that requires a challenging surgical solution for correction along with the post-surgical complications.

Dynamic evolution of size and colour in the highly specialized Zodarion ant-eating spiders.

Ecological specialists constitute relevant case studies for understanding the mechanisms, potential and limitations of evolution. The species-rich and strictly myrmecophagous spiders of the genus Zodarion show diversified defence mechanisms, including myrmecomorphy of different ant species and nocturnality. Through Hybridization Capture Using RAD Probes (hyRAD), a phylogenomic technique designed for sequencing poorly preserved specimens, we reconstructed a phylogeny of Zodarion using 52 (approx. a third of the nominal) species that cover its phylogenetic and distributional diversity. We then estimated the evolution of body size and colour, traits that have diversified noticeably and are linked to defence mechanisms, across the group. Our genomic matrix of 300 loci led to a well-supported phylogenetic hypothesis that uncovered two main clades inside Zodarion. Ancestral state estimation revealed the highly dynamic evolution of body size and colour across the group, with multiple transitions and convergences in both traits, which we propose is likely indicative of multiple transitions in ant specialization across the genus. Our study will allow the informed targeted selection of Zodarion taxa of special interest for research into the group's remarkable adaptations to ant specialization. It also exemplifies the utility of hyRAD for phylogenetic studies using museum material.

Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.