Report Template Research Articles

Design of HL7 FHIR Profiles for Pathology Reports Integrated with Pathology Images.

This paper describes the development of Health Level Seven Fast Healthcare Interoperability Resource (FHIR) profiles for pathology reports integrated with whole slide images and clinical data to create a pathology research database. A report template was designed to collect structured reports, enabling pathologists to select structured terms based on a checklist, allowing for the standardization of terms used to describe tumor features. We gathered and analyzed 190 non-small-cell lung cancer pathology reports in free text format, which were then structured by mapping the itemized vocabulary to FHIR observation resources, using international standard terminologies, such as the International Classification of Diseases, LOINC, and SNOMED CT. The resulting FHIR profiles were published as an implementation guide, which includes 25 profiles for essential data elements, value sets, and structured definitions for integrating clinical data and pathology images associated with the pathology report. These profiles enable the exchange of structured data between systems and facilitate the integration of pathology data into electronic health records, which can improve the quality of care for patients with cancer.

The clinical musculoskeletal ultrasonography: Egyptian guidelines for structured musculoskeletal ultrasound scanning and reporting

BackgroundThe aim of this work is to set up the standards for performing musculoskeletal ultrasound scans and reporting as an additional procedure in the rheumatology setting. We used two rounds of the Delphi approach to get the consensus on a musculoskeletal ultrasound reporting.ResultsFifteen expert panels had completed the two rounds of surveys. After the end of round two, eighteen recommendations distributed upon eight domains were released. The percentage of the agreement on the recommendations was 93.3 to 100 %. All eighteen key questions were answered at the end of the second round with agreement.ConclusionA musculoskeletal ultrasound report template has been developed by this study, based on outcomes of a Delphi process, by an international participants’ panel. All domains met the 80% voting threshold set in this work. The reporting template can be used for both clinical research as well as standard practice to provide guidance and standardize the musculoskeletal ultrasound reporting.

ІНСТРУМЕНТАРІЙ СТРАТЕГІЧНОГО УПРАВЛІННЯ ДІЯЛЬНІСТЮ СУБ’ЄКТІВ РИНКУ НЕРУХОМОСТІ

In the ever-evolving world of property management, technology has become indispensable for streamlining operations, increasing efficiency and improving decision-making processes. As the industry becomes increasingly complex and competitive, real estate professionals rely on a variety of strategic tools and software solutions to manage real estate, analyze market trends, communicate with stakeholders, and streamline administrative tasks. The article defines trends in the modern real estate market. The essence of strategic management, its importance for long-term stable activity is defined. The essence of strategic management in the field of real estate is specified, taking into account the characteristics of the market object – buildings, structures, land and infrastructure. Growth forecasts of the global real estate market have been determined. Strategic management tools are defined: strategic analysis, strategic planning, organization of strategy selection and implementation, and strategic control. Each of them is considered in more detail. The need for a strategic analysis of the real estate market, as well as the main strategies by which this process can be carried out, is determined. The theoretical information has been transferred to the practical plane. The value of diversification, building a network of connections and adaptation through constant updating of knowledge is established. New paradigms in the field of real estate using new technologies have been identified. Features grouped together that offer leading solutions in this space. The statistics of technological indebtedness of enterprises on the real estate market have been determined. The areas of optimization of strategic management of lease operations are analyzed. Prospects for improving the tools of strategic management of the activities of real estate market entities were studied: expanded work and communication opportunities, the emergence of flexible detailed report customization options, predictive analytics based on AI, report templates with flexible settings, real-time data visualization, etc.

Using Gerontechnology for Care Transition Conversations in Senior Living

Every day across the United States, thousands of senior living organizations assist with housing transition decisions for older adults experiencing health-related changes. These decisions impact resources for older adults and senior housing corporations, yet these decisions are based primarily on subjective observational data regarding older adults’ changes in function or cognition. Smart homes offering continuous, unobtrusive health monitoring with artificial intelligence capabilities are emerging as solutions offering health maintenance support and objective functional and health information. Such systems are well-positioned to support hospitality staff conversing with residents about transitioning from independent to assisted living. Our interdisciplinary nursing research and hospitality student team used data from two multi-year smart home studies and Stanford Design Thinking to create a case report template to discern how this objective information might be used during housing transition conversations. We interviewed senior living executives and frontline staff having experience with our prototype smart home to co-design the report template. This article presents our case report template and exploratory findings suggesting that standardized reports displaying functional and cognitive changes over time may support hospitality teams assisting older adults and their families with housing transition decisions.

MRI Features of Pelvic Nerve Involvement in Endometriosis.

Endometriosis is a common condition that mostly affects people assigned as female at birth. The most common clinical symptom of endometriosis is pain. Although the mechanism for this pain is poorly understood, in some cases, the nerves are directly involved in endometriosis. Endometriosis is a multifocal disease, and the pelvis is the most common location involved. Nerves in the pelvis can become entrapped and involved in endometriosis. Pelvic nerves are visible at pelvic MRI, especially when imaging planes and sequences are tailored for neural evaluation. In particular, high-spatial-resolution anatomic imaging including three-dimensional isotropic imaging and contrast-enhanced three-dimensional short inversion time inversion-recovery (STIR) fast spin-echo sequences are useful for nerve imaging. The most commonly involved nerves are the sciatic, obturator, femoral, pudendal, and inferior hypogastric nerves and the inferior hypogastric and lumbosacral plexuses. Although it is thought to be rare, the true incidence of nerve involvement in endometriosis is not known. Symptoms of neural involvement include pain, weakness, numbness, incontinence, and paraplegia and may be constant or cyclic (catamenial). Early diagnosis of neural involvement in endometriosis is important to prevent irreversible nerve damage and chronic sensorimotor neuropathy. Evidence of irreversible damage can also be seen at MRI, and radiologists should evaluate pelvic nerves that are commonly involved in endometriosis in their search pattern and report template to ensure that this information is incorporated into treatment planning.

From omission to excellence: Reducing the percentage of incomplete trainee reports by ensuring documentation of comparison studies

The inclusion of comparison studies within radiology reports is an important, standard practice. Despite this, we identified that after-hours preliminary reports rendered by trainees within our institution often omitted reference to comparison studies for pediatric inpatient portable radiographs. We addressed this issue through a quality improvement project targeting pediatric radiographs. Key interventions included modifying the structured reports by removing default text in the comparison field, designating the comparison field as mandatory, and restructuring the report templates to remove extraneous information. We also initiated a targeted educational campaign. 392 reports before and 267 reports after intervention (total 732 reports) were evaluated to determine the number of reports lacking comparison information when comparisons were available. Following the interventions, there was a statistically significant decrease in incomplete reports from 12.5% to 6%. This project highlights the success of utilizing structured reporting to improve the quality of trainee reports.

Acute Colonic Diverticulitis: CT Findings, Classifications, and a Proposal of a Structured Reporting Template.

Acute colonic diverticulitis (ACD) is the most common complication of diverticular disease and represents an abdominal emergency. It includes a variety of conditions, extending from localized diverticular inflammation to fecal peritonitis, hence the importance of an accurate diagnosis. Contrast-enhanced computed tomography (CE-CT) plays a pivotal role in the diagnosis due to its high sensitivity, specificity, accuracy, and interobserver agreement. In fact, CE-CT allows alternative diagnoses to be excluded, the inflamed diverticulum to be localized, and complications to be identified. Imaging findings have been reviewed, dividing them into bowel and extra-intestinal wall findings. Moreover, CE-CT allows staging of the disease; the most used classifications of ACD severity are Hinchey's modified and WSES classifications. Differential diagnoses include colon carcinoma, epiploic appendagitis, ischemic colitis, appendicitis, infectious enterocolitis, and inflammatory bowel disease. We propose a structured reporting template to standardize the terminology and improve communication between specialists involved in patient care.

SFM Fetal Therapy Practice Guidelines: Fetal Reduction

AbstractThe indications of fetal reduction can be multifetal reduction (MFR) or selective fetal reduction. In MFR, the objective is to reduce the number of fetuses, whereas in selective fetal reduction the abnormal fetus is targeted for reduction. Reduction in the monochorionic twin pairs resulted in the most favorable pregnancy outcome among triplets and should be recommended whenever fetal reduction is an option. Selective termination by potassium chloride injection is contraindicated with monochorionic gestations because death of the unaffected twin occurs in 80 to 100% of cases. The standard operating procedures discuss various aspects of fetal reduction in detail like indications, consent, procedural details, risks and complications, and follow-up. It also gives a report template that can be used in your clinical practice.

Exploring the Potential Role of Upper Abdominal Peritonectomy in Advanced Ovarian Cancer Cytoreductive Surgery Using Explainable Artificial Intelligence.

The Surgical Complexity Score (SCS) has been widely used to describe the surgical effort during advanced stage epithelial ovarian cancer (EOC) cytoreduction. Referring to a variety of multi-visceral resections, it best combines the numbers with the complexity of the sub-procedures. Nevertheless, not all potential surgical procedures are described by this score. Lately, the European Society for Gynaecological Oncology (ESGO) has established standard outcome quality indicators pertinent to achieving complete cytoreduction (CC0). There is a need to define what weight all these surgical sub-procedures comprising CC0 would be given. Prospectively collected data from 560 surgically cytoreduced advanced stage EOC patients were analysed at a UK tertiary referral centre.We adapted the structured ESGO ovarian cancer report template. We employed the eXtreme Gradient Boosting (XGBoost) algorithm to model a long list of surgical sub-procedures. We applied the Shapley Additive explanations (SHAP) framework to provide global (cohort) explainability. We used Cox regression for survival analysis and constructed Kaplan-Meier curves. The XGBoost model predicted CC0 with an acceptable accuracy (area under curve [AUC] = 0.70; 95% confidence interval [CI] = 0.63-0.76). Visual quantification of the feature importance for the prediction of CC0 identified upper abdominal peritonectomy (UAP) as the most important feature, followed by regional lymphadenectomies. The UAP best correlated with bladder peritonectomy and diaphragmatic stripping (Pearson's correlations > 0.5). Clear inflection points were shown by pelvic and para-aortic lymph node dissection and ileocecal resection/right hemicolectomy, which increased the probability for CC0. When UAP was solely added to a composite model comprising of engineered features, it substantially enhanced its predictive value (AUC = 0.80, CI = 0.75-0.84). The UAP was predictive of poorer progression-free survival (HR = 1.76, CI 1.14-2.70, P: 0.01) but not overall survival (HR = 1.06, CI 0.56-1.99, P: 0.86). The SCS did not have significant survival impact. Machine Learning allows for operational feature selection by weighting the relative importance of those surgical sub-procedures that appear to be more predictive of CC0. Our study identifies UAP as the most important procedural predictor of CC0 in surgically cytoreduced advanced-stage EOC women. The classification model presented here can potentially be trained with a larger number of samples to generate a robust digital surgical reference in high output tertiary centres. The upper abdominal quadrants should be thoroughly inspected to ensure that CC0 is achievable.

Narrative operative reports inconsistently record surgical information relating to resection of soft tissue sarcomas and mast cell tumors in dogs.

To report to what degree narrative operative reports for soft tissue sarcoma (STS) and mast cell tumor (MCT) resections met a predetermined template made up of essential elements. 197 consecutive client-owned animals between May 1, 2017, and August 1, 2022. A consensus list of 9 elements made up the final synoptic operative report (SR) template. Consecutive narrative surgery reports (NRs) of dogs that underwent MCT or STS resection were then reviewed to determine how many of the SR elements were present in each NR. A score was then determined for each NR out of a maximum total of 9. Overall, 197 reports (99 MCT and 98 STS) were included. The median score was 5 (56% of elements reported). No report had all 9 elements, and 1 report had none of the elements reported. When MCT and STS were analyzed independently, the median score was 6 (67% of elements reported) for MCT and 5 (56% of elements reported) for STS. There was a trend of more cases with MCT that had a preoperative diagnosis, intraoperative measurements of the tumor, and surgeon margins marked compared to dogs with STS. More dogs with STS had an estimated Enneking dose compared to dogs with MCT. Our data show that essential elements of STS and MCT resection in dogs were inconsistently recorded and no case had all elements present. This mirrors data in people and presses the need for more standardization in reporting of cancer operations in veterinary medicine.

Bone Tumor Risk Stratification and Management System: A Consensus Guideline from the ACR Bone Reporting and Data System Committee

The assessment and subsequent management of a potentially neoplastic bone lesion seen at diagnostic radiography is often complicated by diagnostic uncertainty and inconsistent management recommendations. Appropriate clinical management should be directed by risk of malignancy. Herein, the ACR-sponsored Bone Reporting and Data System (Bone-RADS) Committee, consisting of academic leaders in the fields of musculoskeletal oncology imaging and orthopedic oncology, presents the novel Bone-RADS scoring system to aid in risk assignment and provide risk-aligned management suggestions. When viewed in the proper clinical context, a newly identified bone lesion can be risk stratified as having very low, low, intermediate, or high risk of malignancy. Radiographic features predictive of risk are reviewed include margination, pattern of periosteal reaction, depth of endosteal erosion, pathological fracture, and extra-osseous soft tissue mass. Other radiographic features predictive of histopathology are also briefly discussed. To apply the Bone-RADS scoring system to a potentially neoplastic bone lesion, radiographic features predictive of risk are each given a point value. Point values are summed to yield a point total, which can be translated to a Bone-RADS score (1-4) with corresponding risk assignment (very low, low, intermediate, high). For each score, evidence-based and best practice consensus management suggestions are outlined. Examples of each Bone-RADS scores are presented, and a standardized diagnostic radiography report template is provided.

Results of an International Survey on Spinal Imaging by the ASNR/ASSR/ESNR/ESSR "Nomenclature 3.0" Working Group.

Our goal was to determine if "Nomenclature 2.0," the classification of lumbar disk pathology consensus, should be updated. We conducted a social media and e-mail-based survey on preferences regarding the use of classification on magnetic resonance spine reporting. Members of the European Society of Neuroradiology, European Society of Musculoskeletal Radiology, American Society of Neuroradiology, and American Society of Spine Radiology received a 15-question online survey between February and March 2022. A total of 600 responses were received from 63 countries. The largest number of responses came from Italy and the United States. We found that 71.28% of respondents used Nomenclature 2.0, Classification of Lumbar Disk Pathology. But classification on stenosis is used less often: 53.94% and 60% of respondents do not use any classification of spinal canal stenosis and foraminal stenosis, respectively. When queried about which part of Nomenclature needs improving, most respondents asked for a Structured Reporting Template (SRT), even though 58.85% of respondents do not currently use any template and 54% routinely use a clinical information questionnaire. These results highlight the importance of an updated Nomenclature 3.0 version that integrates the classifications of lumbar disk disease and spinal canal and foraminal stenosis. Further attention should also be directed toward developing a robust endorsed SRT.

Report template from the German Society of Urology and the German Radiological Society for standardized, structured reporting of native computed tomography scans in the diagnosis of urinary stones

Standardized structured radiological reporting (SSRB) has been promoted in recent years. The aims of SSRB include that reports be complete, clear, understandable, and stringent. Repetitions or superfluous content should be avoided. In addition, there are advantages in the presentation of chronological sequences, tracking and correlations with structured findings from other disciplines and also the use of artificial intelligence (AI)-based methods. The development of the presented template for SSRB of native computed tomography for urinary stones followed the "process for the creation of quality-assured and consensus-based report templates as well as subsequent continuous quality control and updating" proposed by the German Radiological Society (DRG). This includes several stages of drafts, consensus meetings and further developments. The final version was published on the DRG website ( www.befundung.drg.de ). The template will be checked annually by the steering group and adjusted as necessary. The template contains 6organ domains (e.g., right kidney) for which entries can be made for atotal of 21different items, mostly with selection windows. If "no evidence of stones" is selected for an organ in the first query, the query automatically jumps to the next organ, so that the processing can be processed very quickly despite the potentially high total number of individual queries for all organs. The German, European, and North American Radiological Societies perceive the establishment of astandardized structured diagnosis of tomographic imaging methods not only in oncological radiology as one of the current central tasks. With the present template for the description of computed tomographic findings for urinary stone diagnostics, we are presenting the first version of aurological template. Further templates for urological diseases are to follow.

EEG Weaver Reporter. A Freeware software for neurophysiologic reports.

EEG Weaver Reporter (EWR) is a windows application (app) to be used by neurophysiologists to report electroencephalogram (EEG) findings. We wrote EWR because of colleagues’ complaints about the reports generated by some EEG softwares. Some app reports have unprofessional or very automatic aspect. Besides the lack of a report databank in those app is a major issue. EWR can help researches and clinical neurophysiologists to describe their EEG analysis results. EWR is free, light, and simple to use. It creates EEG reports exportable to pdf and MS word. Users can generate as many databanks as needed to store their reports. Each of those databanks can store reusable EEG report templates, classified by patient’s name. Databanks and individual reports can be shared with patients and colleagues.

Rectal Biopsy for Hirschsprung's Disease: A Multicentre Study Involving Biopsy Technique, Pathology and Complications.

The heterogeneity of rectal biopsy techniques has encouraged us to search for a surgical and pathological standardisation of this diagnostic technique to exclude Hirschsprung's disease. The different amounts of information on the anatomopathology report prompted us to compile a template for the anatomopathology report for diagnostic rectal biopsies for surgical colleagues and pathologists working on Hirschsprung's disease. We gathered the anonymous biopsy information and its pathology information from five hospitals for all patients in which rectal biopsies were taken to diagnose Hirschsprung's disease over two years (2020-2021). Of the 82 biopsies, 20 suction (24.4%), 31 punch (37.8%) and 31 open biopsies (37.8%) were taken. Of all biopsies, 69 were conclusive (84.2%), 13 were not (15.8%). In the suction biopsy group, 60% were conclusive and 40% were not; for punch biopsy, the values were 87% and 13%, respectively and for open biopsy, 97% and 3%. Inconclusive results were due to insufficient submucosa in 6/8 suction biopsies, 4/4 punch biopsies and 0/1 open biopsies. An insufficient amount of submucosa was the reason for an inconclusive result in 6/20 cases (30%) after suction biopsy, 4/31 (12.9%) cases after punch biopsy and 0 cases (0%) after open biopsy. We had one case with major postoperative bleeding post suction biopsy; there were no further adverse effects after biopsy. Diagnostic rectal biopsies in children are safe. Non-surgical biopsies are more likely to give inconclusive results due to smaller amounts of submucosa present in the specimen. Open biopsies are especially useful when previous non-surgical biopsies are inconclusive. An experienced pathologist is a key factor for the result. The anatomopathology report should specify the different layers present in the specimen, the presence of ganglion cells and hypertrophic nerve fibres, their description and a conclusion.

Challenges, Barriers, and Successes of Standardized Report Templates: Results of a Society of Interventional Radiology Survey

Registry data are being increasingly used to establish treatment guidelines, set benchmarks, allocate resources, and make payment decisions. Although many registries rely on manual data entry, the Society of Interventional Radiology (SIR) is using automated data extraction for its VIRTEX registry. This process relies on participants using consistent terminology with highly structured data in physician-developed standardized reports (SR). To better understand barriers to adoption, a survey was sent to 3,178 SIR members. Responses were obtained from 451 interventional radiology practitioners (14.2%) from 92 unique academic and 151 unique private practices. Of these, 75% used structured reports and 32% used the SIR SR. The most common barriers to the use of these reports include SR length (35% of respondents), lack of awareness about the SR (31%), and lack of agreement on adoption within practices (27%). The results demonstrated insights regarding barriers in the use and/or adoption of SR and potential solutions.

Value of CT in COVID-19-pandemia: A systematic analysis of CT-findings and outcomes in patients with COVID-19 pneumonia.

Chest-computer tomography (CT) is a crucial factor in the clinical course and evaluation of patients with COVID-pneumonia. In the initial phase of the COVID-19 pandemic little information was known on the prognostic value of the initially taken thoracic CTs. The purpose of this study was to determine predictive values for clinical outcome based on CT classification of the pulmonary pathologies in patients with COVID-pneumonia. This single center study included 51 non-immunized patients during the first COVID-19 outbreak in Germany. The patients underwent a clinically indicated chest-CT. Using the radiological society of North America (RSNA)-report template, chest-CTs were classified into 4 categories (typical, atypical, indeterminate, and no changes). We analyzed the outcomes based on these imaging classifications and relevant comorbidities. Among the 51 patients of our study population 14 (27.5%) patients had a lethal outcome. Typical radiological COVID-19 pattern was found in 92.9% of the deceased patients and in 59.5% of the surviving patients (P = .022). The lethal group showed a significant higher proportion of diabetes mellitus (50% vs 10.8%; P = .003) and arterial hypertension (aHTN) (85.7% vs 54.1%; P = .037). Male sex, higher age and coronary heart disease (CHD) were also seen more often in the lethal group. In patients with clinically proven COVID-19 pneumonia, typical chest CT findings show a negative outcome. A classification system used in this study is helpful for classifying imaging features and is recommended as a standardized CT reporting tool. It could also help in triaging of the therapy of patients with COVID-19 pneumonia. Especially the comorbidities, diabetes and arterial hypertonia triggered a negative outcome in our study population.

Acute pancreatitis: Structured report template of magnetic resonance imaging.

Acute pancreatitis (AP) is a common acute abdomen disease of the digestive system. It has a potentially fatal risk because of its variable severity and various complications. With the widespread application of the Revised Atlanta Classification, new requirements for AP imaging reports are introduced. Experts in abdominal radiology and pancreatology in the United States published the first structured computed tomography reporting template for AP in 2020. However, there is no corresponding structured magnetic resonance imaging (MRI) reporting template globally. Therefore, this article focuses on the structured MRI report of AP images from our pancreatitis imaging center, which is intended to improve the systematic understanding of this disease and standardize the writing of MRI structured reports. In the meantime, we aim to promote the clinical diagnosis and assessment of MRI efficacy for AP and its multiple complications. It is further intended to facilitate academic exchanges and scientific research between different medical centers.

P-288 Chat Generative Pre-trained Transformer (ChatGPT) Proves to be an Effective Assistant for Clinical Embryologists in Laboratory Tasks: A Pilot Cross-sectional Study

Abstract Study question What are the capabilities of ChatGPT in troubleshooting, fact-checking and generating report templates in the in vitro fertilization (IVF) laboratory? Summary answer Clinical embryologists perceived ChatGPT as accurate and comprehensive in troubleshooting, generating standard operating procedures (SOP), writing reports and fact-finding in the IVF laboratory. What is known already ChatGPT is an artificial intelligence (AI)-driven chat robot (chatbot) with 175 billion parameters in its natural language processing model. It is remarkable for its concise, human-like answers to user inquiries. With advanced AI technology, ChatGPT provides in-depth responses, handles complex problems, and addresses intricate questions. This chatbot has received significant recognition and is anticipated to encourage users to employ it for practical applications, including in the IVF laboratory. However, the abilities of ChatGPT in executing various tasks (such as troubleshooting, generating SOPs) in the in vitro fertilization (IVF) laboratory have not been investigated yet. Study design, size, duration The aim of this cross-sectional study is to assess the proficiency of ChatGPT in four tasks commonly performed by embryologists: troubleshooting, designing SOPs, composing reports, and fact-checking. An anonymous online survey of clinical embryologists (n = 40) was conducted to achieve this aim. It was performed between December 2022 and January 2023. Participants/materials, setting, methods Clinical embryologists participated in a five-point Likert scale (1-Very disagree to 5-Very agree) questionnaire. Participants were presented with eight vignettes generated by ChatGPT related to the investigated four tasks. Embryologists provide ratings about both their perceived accuracy and perceived completeness of the provided answers. We then asked about their intention to incorporate ChatGPT into their daily tasks. Main results and the role of chance The median years of experience of survey participants was 11.5 years (IQR 8-18). Among the participants, 37.5% held an undergraduate bachelor's degree, while the largest proportion, 62.5%, held graduate degrees (Masters and doctorates). Embryologists rated ChatGPT as having an accurate (mean Likert score of 3.45) and comprehensive (mean Likert score of 3.36) value for troubleshooting. They also considered it to be accurate (mean Likert score of 3.34) and comprehensive (mean Likert score of 3.26) for writing SOP templates. Furthermore, they found ChatGPT to have an accurate (mean Likert score of 3.71) and comprehensive (mean Likert score of 3.66) value for report writing. Additionally, they deemed ChatGPT to have both an accurate and comprehensive value (mean Likert score of 3.67) for verifying facts. Overall, experienced embryologists perceived an added value of ChatGPT (Likert scores ≥3). On average, they rated ChatGPT as accurate (average score of 3.54) and comprehensive (average score of 3.49) in all tasks tested. They also expressed an intention to use ChatGPT in their laboratory work (average Likert, 3.58). Limitations, reasons for caution The embryologists who participated in the survey were highly experienced. Wider implications of the findings The model has the potential to assist clinical embryologists in resolving issues and performing administrative duties, making it a valuable resource. Embryologists may benefit from integrating ChatGPT into their educational and certification processes, as well as their daily tasks. Trial registration number Not applicable

Operationalising targeted next-generation sequencing for routine diagnosis of drug-resistant TB.

Phenotypic drug susceptibility testing (pDST) for Mycobacterium tuberculosis can take up to 8 weeks, while conventional molecular tests identify a limited set of resistance mutations. Targeted next-generation sequencing (tNGS) offers rapid results for predicting comprehensive drug resistance, and this study sought to explore its operational feasibility within a public health laboratory in Mumbai, India. Pulmonary samples from consenting patients testing Xpert MTB-positive were tested for drug resistance by conventional methods and using tNGS. Laboratory operational and logistical implementation experiences from study team members are shared below. Of the total number of patients tested, 70% (113/161) had no history of previous TB or treatment; however, 88.2% (n = 142) had rifampicin-resistant/multidrug-resistant TB (RR/MDR-TB). There was a high concordance between resistance predictions of tNGS and pDST for most drugs, with tNGS more accurately identifying resistance overall. tNGS was integrated and adapted into the laboratory workflow; however, batching samples caused significantly longer result turnaround time, fastest at 24 days. Manual DNA extraction caused inefficiencies; thus protocol optimisations were performed. Technical expertise was required for analysis of uncharacterised mutations and interpretation of report templates. tNGS cost per sample was US$230, while for pDST this was US$119. Implementation of tNGS is feasible in reference laboratories. It can rapidly identify drug resistance and should be considered as a potential alternative to pDST.