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The authors propose the generation of a multi-institutional TBI registry. Barriers to registry implementation include: (1) difficulties in acquiring ethical approval; (2) incomplete clinical data available; (3) lack of information and insufficient technology (IT) support; (4) limited available resources; (5) time constraints involving understaffing yet managing high patient volumes; (6) time constraints associated with entering patient data into the registry tool. The authors detail the current state of affairs on neurotrauma registries worldwide and propose the creation of a multi-institutional, global neurotrauma registries. This private-public partnership will enable appropriate balance among stakeholders while offering care to the largest number of citizens. This initiative will require coordinated efforts involving vetted members of organized neurosurgery. Support from these entities, such as fellowship program creation, provided funding through travel vouchers to LMICs, secured housing and transportation costs in LMI nations, facilitated meetings with global local stakeholders, and promotion of key developments via social media, will accelerate the creation of this global neurotrauma registry. We propose the creation of a global TBI registry, in partnership with large, academic medical centers. Several proposed limitations of registry implementation can be addressed with support from local stakeholders, including government officials and administrative members at key institutions. Several American institutions have well-established global health programs to support this initiative. Further, at Harvard Medical School, the program in Global Surgery and Social Change offers the Paul Farmer Global Surgery Fellowship that trains leaders in policy development and implementation. The fellowship consists of 2 separate tracks: a 2-year research fellow (PGY-5-PGY-6) and 1-year research associate (MD and MBBS, etc.). Funding could be allocated towards creating a year-long fellowship dedicated towards implementing a neurotrauma registry, with this selected scholar granted the resource and connections to network with government officials and healthcare groups in every nation within that jurisdiction. A scholar would be assigned a region of the world with the goal to generate a registry that would later be combined with those generated by peer scholars. In addition, we propose the creation of a fund, controlled by donors, as a funding model.

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Osteoporosis Canada 2023 clinical practice guidelines increase the number of individuals recommended or suggested for anti-osteoporosis pharmacotherapy by refining treatment guidance for those who fell within the 2010 guidelines' moderate-risk category. PURPOSE: In 2023, Osteoporosis Canada updated its 2010 clinical practice guidelines based upon consideration of fracture history, 10-year major osteoporotic fracture (MOF) risk, and BMD T-score in conjunction with age. The 2023 guidelines eliminated risk categories, including the moderate-risk group that did not provide clear treatment guidance. The current study was performed to appreciate the implications of the shift from 2010 risk categories to 2023 treatment guidance. METHODS: The study population consisted of 79,654 individuals age ≥ 50 years undergoing baseline DXA testing from January 1996 to March 2018. Each individual was assigned to mutually exclusive categories based on 2010 and 2023 guideline recommendations. Treatment qualification, 10-year predicted and 10-year observed MOF risk were compared. RESULTS: Treatment reclassification under the 2023 guidelines only affected 33.8% of individuals in the 2010 moderate-risk group, with 13.0% assigned to no treatment, 14.4% to suggest treatment, and 6.4% to recommend treatment. During the mean follow-up of 7.2 years, 6364 (8.0%) individuals experienced one or more incidents of MOF. The observed 10-year cumulative incidence of MOF in the study population was 10.5% versus the predicted 10.7% (observed to predicted mean calibration ratio 0.98, 95% CI 0.96-1.00). Individuals reclassified from 2010 moderate risk to 2023 recommend treatment were at greater MOF risk than those in the 2010 moderate-risk group assigned to 2023 suggest treatment or no treatment, but at lower risk than those in the 2010 high-risk group. CONCLUSIONS: Osteoporosis Canada 2023 clinical practice guidelines affect individuals within the 2010 moderate-risk category, increasing the number for whom anti-osteoporosis pharmacotherapy is recommended or suggested. Increased treatment could reduce the population burden of osteoporotic fractures, though moderate-risk individuals now qualifying for treatment have a lower predicted and observed fracture risk than high-risk individuals recommended for treatment under the 2010 guidelines.

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BACKGROUND: The lifestyle differences of Anabaptists and their views on health care may yield different injury patterns than standard populations and require a customized approach to injury prevention and health care delivery. OBJECTIVE: To identify differences in injury patterns and delays in care-seeking behaviors among the Anabaptists in Wisconsin. METHODS: This single-center retrospective cohort study was conducted from (23 years) January 1, 2000, to December 31, 2023. Local Trauma Registry data collected patient demographics, injury details, morbidity outcomes, in-hospital mortality, and preexisting comorbidity. Anabaptist trauma patients were isolated by confirmed identification in the Trauma Registry. The analysis utilized both descriptive statistics and a logistic regression model with the outcome of Anabaptist. RESULTS: A total of 14,431 patients were included in the analysis; 81 (0.4%) were confirmed as Anabaptist. The Anabaptist population showed a higher likelihood of helicopter transportation (odds ratio [OR] 4.64, p < .01) and an activation of Pediatric Level I (OR 4.07, p < .01). As the emergency department shock index increased by one unit, the odds of being Anabaptist increased by 9.87 (p < .01). The injury mechanisms that were associated with the Anabaptist population included buggy collisions (OR 312.58, p < .01), caught or crushed (OR 5.21, p = .01), machinery (OR 5.38, p < .01), near drowning (OR 14.09, p < .01), scooter (OR 13.93, p = .04), and woodworking (OR 12.81, p = .01). CONCLUSIONS: This study identified differences in injury patterns and delays in care-seeking behaviors in the Anabaptist population.

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BACKGROUND: Needle thoracostomy is a potentially life-saving intervention for tension pneumothorax but may be overused, potentially leading to unnecessary morbidity. OBJECTIVE: To review prehospital needle thoracostomy indications, effectiveness, and adverse outcomes. METHODS: A retrospective cohort study was conducted based on registry data for a United States Midwestern Level I trauma center for a 7.5-year period (January 2015 to May 2022). Included were patients who received prehospital needle thoracostomy and trauma activation before hospital arrival. The primary outcomes were correct indications and improvement in vital signs. Secondary outcomes were the need for chest tubes, correct needle placement, complications, and survival. RESULTS: A total of n = 67 patients were reviewed, of which n = 63 (94%) received a prehospital thoracostomy. Of the 63 prehospital thoracostomies, 54 (86%) survived to arrival. Of these 54, 44 (n = 81%) had documented reduced/absent breath sounds, 15 (28%) hypotension, and 19 (35%) with difficulty breathing/ventilating. Only four patients met all three prehospital trauma life support criteria: hypotension, difficulty ventilating, and absent breath sounds. There were no significant changes in prehospital vitals before and after receiving needle thoracostomy. In patients receiving imaging (n = 54), there was evidence of 15 (28%) lung lacerations, 6 (11%) of which had a pneumothorax and 3 (5%) near misses of important structures. Review of needle catheters visible on computer tomography imaging found 11 outside the chest and 1 in the abdominal cavity. CONCLUSION: The study presents evidence of potential needle thoracostomy overuse and morbidity. Adherence to specific guidelines for needle decompression is needed.

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BACKGROUND: Comparing causal effect estimates obtained using observational data to those obtained from the gold standard (i.e., randomized controlled trials [RCTs]) helps assess the validity of these estimates. However, comparisons are challenging due to differences between observational data and RCT generated data. The unknown treatment assignment mechanism in the observational data and varying sampling mechanisms between the RCT and the observational data can lead to confounding and sampling bias, respectively. AIMS: The objective of this study is to propose a two-step framework to validate causal effect estimates obtained from observational data by adjusting for both mechanisms. MATERIALS AND METHODS: An estimator of causal effects related to the two mechanisms is constructed. A two-step framework for comparing causal effect estimates is derived from the estimator. An R package RCTrep is developed to implement the framework in practice. RESULTS: A simulation study is conducted to show that using our framework observational data can produce causal effect estimates similar to those of an RCT. A real-world application of the framework to validate treatment effects of adjuvant chemotherapy obtained from registry data is demonstrated. CONCLUSION: This  study constructs a framework for comparing causal effect estimates between observational data and RCT data, facilitating the assessment of the validity of causal effect estimates obtained from observational data.

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BACKGROUND: European and North-American guidelines on management of H. pylori infection in children provide the option not to treat even if the infection is endoscopically confirmed. We used data from the EuroPedHp Registry to identify factors associated with therapy decisions. METHODS: We included treatment-naïve patients reported between 2017 and 2020 from 30 centers in 17 European countries. Multivariable logistic regression identified factors including comorbidities within and outside the gastrointestinal (GI) tract influencing the decision for or against therapy. RESULTS: Of 1165 patients (52% females, median age 12.8), 28% (321/1165) reported any alarm symptom, 26% (307/1165) comorbidities, and 16% (192/1165) did not receive eradication treatment. Therapy was initiated less often in children having any GI comorbidity (57%, n = 181), particularly in those with eosinophilic esophagitis (60%, n = 35), inflammatory bowel disease (54%, n = 28), and celiac disease (43%, n = 58), compared to those with non-GI (86%, n = 126) or no comorbidity (89%, n = 858), despite similar frequencies of alarm and non-alarm symptoms, ulcers, erosions, and nodular gastritis. Patients with GI and without comorbidities remained more likely untreated in high versus low H. pylori prevalence countries (p < 0.0001). In children without comorbidities, factors favoring therapy included older age, being overweight, having symptoms, erosions, antral nodularity, and available antibiotic susceptibility results. CONCLUSION: In this cohort, H. pylori-infected children with GI comorbidities compared to no comorbidity showed 75% reduced chance of receiving eradication therapy. We found no evidence supporting different management strategies in infected patients with GI comorbidities compared to all pediatric patients with endoscopically proven H. pylori infection.

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Background: Colorectal cancer is one of the most common forms of cancer in Norway, and typically develops from colorectal polyps. For benign colorectal polyps, endoscopic removal is recommended to avoid unnecessary surgery. This study identifies the extent of surgical treatment of benign polyps in the period 1 January 2008-31 December 2021. Material and method: We obtained statistics from the Norwegian Patient Registry on the surgical resection of benign colorectal polyps, number of colonoscopies performed and number of patients with the diagnostic code for benign polyp in the study period. Population size from Statistics Norway was used to calculate annual incidences of the procedure. Results: The number of patients with benign polyps increased from 211 per 100 000 population to 444 per 100 000 during the study period. The number of colonoscopies increased from 9.4 per 1 000 population to 16.7 per 1 000. The number of surgical resections of benign colorectal polyps per year increased from 4.2 per 100 000 population to 6.3 per 100 000. The total number of unique patients with benign polyps in the period was 215 736, of which 2.1 % received surgical treatment, with the figures varying from 2.0 % in 2008 to 1.6 % in 2021. Interpretation: Our results show that surgical treatment of benign polyps is still widespread in Norway. This impacts on patient safety and health economics. We propose the establishment of multidisciplinary teams and enhanced endoscopic competence in Norwegian health trusts.

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BACKGROUND: The New York State Birth Defects Registry (BDR) has passive and active components. As part of statewide passive ascertainment, the BDR receives reports of International Classification of Diseases, Tenth Revision (ICD-10) codes and descriptive narratives on a wide range of birth defects. The BDR conducts enhanced active surveillance for selected birth defects in 14 counties, which includes medical record abstraction and clinician review. We sought to quantify agreement between the two surveillance approaches. METHODS: The analysis included live-born infants born with one of the 16 birth defects in 2018-2021 in the active surveillance counties (n = 1069 infants). We calculated positive predictive values (PPV) and 95% confidence intervals for each defect, defined as the percentage of cases confirmed in active surveillance among those in passive surveillance. Additionally, we calculated the percentage with each birth defect missed by passive surveillance. RESULTS: The PPV varied greatly by birth defect. The PPV was >90% for gastroschisis and cleft lip, but <70% for spina bifida, diaphragmatic hernia, truncus arteriosus, tricuspid atresia, hypoplastic left heart syndrome, coarctation of the aorta, and pulmonary atresia. The percentage missed by passive surveillance ranged from 2% for tetralogy of Fallot to 39% for tricuspid atresia. CONCLUSIONS: Active surveillance is an important strategy for ruling out false positive case reports for certain birth defects that we assessed, but not all of them. Passive surveillance programs can use our findings to develop targeted strategies for improving data quality of specific birth defects using active surveillance methods, thus optimizing limited resources.

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PURPOSE: Pregnancies ending before gestational week 12 are common but not notified to the Medical Birth Registry of Norway. Our goal was to develop an algorithm that more completely detects and dates all possible pregnancy outcomes (i.e., miscarriages, elective terminations, ectopic pregnancies, molar pregnancies, stillbirths, and live births) by using diagnostic codes from primary and secondary care registries to complement information from the birth registry. METHODS: We used nationwide linked registry data between 2008 and 2018 in a hierarchical manner: We developed the UiO pregnancy algorithm to arrive at unique pregnancy outcomes, considering codes within 56 days as the same event. To estimate the gestational age of pregnancy outcomes identified in the primary and secondary care registries, we inferred the median gestational age of pregnancy markers (45 ICD-10 codes and 9 ICPC-2 codes) from pregnancies registered in the medical birth registry. When no pregnancy markers were available, we assigned outcome-specific gestational age estimates. The performance of the algorithm was assessed by blinded clinicians. RESULTS: Using only the medical birth registry, we identified 649 703 pregnancies, including 1369 (0.2%) miscarriages and 3058 (0.5%) elective terminations. With the new algorithm, we detected 859 449 pregnancies, including 642 712 live-births (74.8%), 112 257 miscarriages (13.1%), 94 664 elective terminations (11.0%), 6429 ectopic pregnancies (0.7%), 2564 stillbirths (0.3%), and 823 molar pregnancies (0.1%). The median gestational age was 10+1 weeks (IQR 10+0-12+2) for miscarriages and 8+0 weeks (IQR 8+0-9+6) for elective terminations. Gestational age could be inferred using pregnancy markers for 66.3% of miscarriages and 47.2% of elective terminations. CONCLUSION: The UiO pregnancy algorithm improved the detection and dating of early non-live pregnancy outcomes that would have gone unnoticed if relying solely on the medical birth registry information.

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The first Fragility Hip Fracture Registry has been established in Greece. The in-hospital length of stay was 10.8 days and was significantly influenced by the delayed surgical fixation. The increased age, the higher ASA grade, and the male gender influenced negatively the 30-day mortality, which reached 7.5%. BACKGROUND: The increased incidence of fragility hip fractures constitutes a great challenge to the health care professionals and causes a significant burden on national health care systems around the globe. Fragility hip fracture registries have been used in many countries in order to document the cotemporary situation in each country and to identify potential weaknesses of the local health care systems. AIM: The aim of the herein study is to present the results of the pilot implementation of the first fragility hip fracture registry in Greece, which was developed by the Greek Chapter of Fragility Fracture Network (FFN Gr), and use the neural networks in the analysis of the results. MATERIALS AND METHODS: Seven orthopaedic departments from six different hospitals in Greece participated in the present pilot study. All fragility hip fractures from September 2022 until December 2023 were prospectively collected and documented using a central database. For this purpose, the 22 points of minimum common data set, proposed by the Global Fragility Fracture Network, with the addition of the 30-day mortality was used. RESULTS: A total of 1009 patients who sustained a fragility hip fracture were included in the study. The mean age of the cohort was 82.2 ± 8.6 years with the majority of patients being female (72%). Sixty percent (60%) of the patients had an extracapsular hip fracture, with a mean ASA grade 2.6 ± 0.8. Intramedullary nailing and hip hemiarthroplasty were the surgical treatments of choice in the majority of extra- and intra-capsular hip fractures respectively. The mean hospital length of stay of the patients was 10.8 ± 8.5 days, and the 30-day mortality was 7.5%. The multivariant analysis revealed that the age, the ASA grade and the male gender had a significant contribution to the 30-day mortality. The neural network model had a significant under-the-curve predictive value (0.778), with age being the most important predictive factor. The length of stay was significantly influenced only by the delayed surgical fixation (more than 36 h from admission). CONCLUSIONS: The present pilot study provides evidence that establishing a fragility hip fracture registry in Greece is feasible and demonstrates that the minimum common data set can be used as the base of any new registry. In Greece, patients with a fragility hip fracture stay in the hospital for approximately 11 days and have 7.5% 30-day mortality. Unfortunately, due to the logistics of the public healthcare system, they do not receive surgical fixation in a timely manner, which is a factor that negatively affects their length of in-hospital stay.

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INTRODUCTION: The configuration of electronic data capture (EDC) systems has a relevant impact on data quality in studies and patient registries. The objective was to develop a method to visualise the configuration of an EDC system to check the completeness and correctness of the data definition and rules. METHODS: Step 1: transformation of the EDC data model into a graphical model, step 2: Checking the completeness and consistency of the data model, step 3: correction of identified findings. This process model was evaluated on the patient registry EpiReg. RESULTS: Using the graphical visualisation as a basis, 21 problems in the EDC configuration were identified, discussed with an interdisciplinary team, and corrected. CONCLUSION: The tested methodological approach enables an improvement in data quality by optimising the underlying EDC configuration.

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INTRODUCTION: Conducting clinical studies is an integral part of the clinical research repertoire of university hospitals. A wealth of organizational competences must always be available in a central location and in an up-to-date form for appropriate administration. Information such as the number of ongoing studies, and the number of enrolled participants is required for tasks related to e.g. sponsor quality management and KPIs. A registry for clinical trials can answer these questions and enhance the exchange of information. METHODS: Requirements for an in-house registry for clinical trials were defined in a multidisciplinary task force. The requirements included interfaces and key abilities to create customized reports to fulfill the obligation to provide evidence. RESULTS: The study registry is productive since May 2020 and internal interfaces have been implemented to ensure consistency between systems and the documented studies. Manually recorded data is enhanced by interfaces to primary registers. The comprehensive data set in the study register enables the creation of individual queries at any time for a variety of questions. DISCUSSION: The UKSH study register has already demonstrated its usefulness in various applications and several projects. The extensive data set and the modular realization allows many current and future requirements to be met.

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INTRODUCTION: Trial recruitment is a crucial factor for precision oncology, potentially improving patient outcomes and generating new scientific evidence. To identify suitable, biomarker-based trials for patients' clinicians need to screen multiple clinical trial registries which lack support for modern trial designs and offer only limited options to filter for in- and exclusion criteria. Several registries provide trial information but are limited regarding factors like timeliness, quality of information and capability for semantic, terminology enhanced searching for aspects like specific inclusion criteria. METHODS: We specified a Fast Healthcare Interoperable Resources (FHIR) Implementation Guide (IG) to represent clinical trials and their meta data. We embedded it into a community driven approach to maintain clinical trial data, which is fed by openly available data sources and later annotated by platform users. A governance model was developed to manage community contributions and responsibilities. RESULTS: We implemented Community Annotated Trial Search (CATS), an interactive platform for clinical trials for the scientific community with an open and interoperable information model. It provides a base to collaboratively annotate clinical trials and serves as a comprehensive information source for community members. Its terminology driven annotations are coined towards precision oncology, but its principles can be transferred to other contexts. CONCLUSION: It is possible to use the FHIR standard and an open-source information model represented in our IG to build an open, interoperable clinical trial register. Advanced features like user suggestions and audit trails of individual resource fields could be represented by extending the FHIR standard. CATS is the first implementation of an open-for-collaboration clinical trial registry with modern oncological trial designs and machine-to-machine communication in mind and its methodology could be extended to other medical fields besides precision oncology. Due to its well-defined interfaces, it has the potential to provide automated patient recruitment decision support for precision oncology trials in digital applications.

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OBJECTIVE: To determine survival to discharge and neurological outcomes on long-term follow-up of pediatric patients attended for out of-hospital cardiac arrest (OHCA). METHODS: Retrospective study based on an ongoing OHCA registry. Patients aged 16 years or younger were included. Futile resuscitation attempts were excluded. Neurological outcome on hospital discharge and on follow-up was based on variables in the Pediatric Cerebral Performance Category (PCPC) scale. Cases from January 1, 2008, through December 31, 2019, were extracted, and 2 surveys were carried out in May 2021 and January 2023. Patient follow-up time ranged from 1 to 13 years. RESULTS: Of the 13 778 patients in the registry, we found 277 (2.0%) who were aged 16 years or younger. One hundred thirty-seven patients (49.5%) were transported to a hospital, and spontaneous circulation was restored in 99 (35.7%). Thirty-six patients (13%) were discharged. The median (interquartile range) follow-up time was 2172 (978-3035) days. Thirty-one of these patients (86.1%) were alive at follow-up, 3 had died, and 2 were lost to follow-up. Neurological outcomes had worsened in 2 and improved in 6 patients. The neurological outcome of 27 of the 31 patients with complete follow-up data (87.1%) was good (PCPC scores of 1 or 2). CONCLUSIONS: In spite of the low incidence of shockable rhythm in pediatric OHCA, survival with a good neurological outcome is comparable to survival in adults. Children who are discharged after OHCA maintained or improved their neurological function over the long term.

OBJETIVO: Conocer la supervivencia al alta y la evolución neurológica tras seguimiento a largo plazo de pacientes pediátricos atendidos por parada cardíaca extrahospitalaria. METODO: Estudio retrospectivo basado en un registro continuo de parada cardiaca extrahospitalaria. Se incluyeron los pacientes pediátricos (edad menor o igual a 16 años). Se excluyeron reanimaciones consideradas fútiles. Se tomaron como variables resultado el estado neurológico al alta hospitalaria y al seguimiento de los pacientes, siguiendo el modelo de la Pediatric Cerebral Performance Category. El periodo fue del 1 de enero de 2008 al 31 de diciembre de 2019. Se realizaron dos encuestas, en mayo del 2021 y enero del 2023 con un periodo de seguimiento entre 1 y 13 años. RESULTADOS: De los 13.778 pacientes, 277 (2,0%) eran menores de 16 años; 137 (49,5%) trasladados al hospital, 99 de ellos (35,7%) con recuperación de circulación espontánea. Recibieron el alta hospitalaria 36 pacientes (13%). En el seguimiento, mediana (RIC) de 2.172 [978-3.035] días, 31 pacientes (86,1%) seguían con vida, 3 pacientes fallecieron y en dos casos no obtuvimos información. Dos pacientes sufrieron un empeoramiento del estado neurológico y 6 mejoraron. Finalmente, 27 de los 31 pacientes (87,1%) que completaron el seguimiento tenían una buena situación neurológica (PCPC1-2). CONCLUSIONES: A pesar de presentar una incidencia baja, la supervivencia con buen estado neurológico al alta hospitalaria de la parada cardiorrespiratoria extrahospitalaria pediátrica es comparable a la del adulto. Los pacientes pediátricos que recibieron el alta hospitalaria tras una parada cardiorrespiratoria extrahospitalaria mantuvieron o mejoraron su estado neurológico en el seguimiento a largo plazo.

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BACKGROUND: Data monitoring and surveillance systems are the cornerstone for governance and regulation, planning, and policy development for chronic disease care. Our study aims to evaluate health systems capacity for data monitoring and surveillance for kidney care. METHODS: We leveraged data from the third iteration of the International Society of Nephrology Global Kidney Health Atlas (ISN-GKHA), an international survey of stakeholders (clinicians, policymakers and patient advocates) from 167 countries conducted between July and September 2022. ISN-GKHA contains data on availability and types of kidney registries, the spectrum of their coverage, as well as data on national policies for kidney disease identification. RESULTS: Overall, 167 countries responded to the survey, representing 97.4% of the global population. Information systems in forms of registries for dialysis care were available in 63% (n = 102/162) of countries, followed by kidney transplant registries (58%; n = 94/162), and registries for non-dialysis chronic kidney disease (19%; n = 31/162) and acute kidney injury (9%; n = 14/162). Participation in dialysis registries was mandatory in 57% (n = 58) of countries; however, in more than half of countries in Africa (58%; n = 7), Eastern and Central Europe (67%; n = 10), and South Asia (100%; n = 2), participation was voluntary. The least-reported performance measures in dialysis registries were hospitalization (36%; n = 37) and quality of life (24%; n = 24). CONCLUSIONS: The variability of health information systems and early identification systems for kidney disease across countries and world regions warrants a global framework for prioritizing the development of these systems.

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BACKGROUND: Worldwide, the uptake of peritoneal dialysis (PD) compared with hemodialysis remains limited. This study assessed organizational structures, availability, accessibility, affordability and quality of PD worldwide. METHODS: This cross-sectional study relied on data from kidney registries as well as survey data from stakeholders (clinicians, policymakers and advocates for people living with kidney disease) from countries affiliated with the International Society of Nephrology (ISN) from July to September 2022. RESULTS: Overall, 167 countries participated in the survey. PD was available in 79% of countries with a median global prevalence of 21.0 [interquartile range (IQR) 1.5-62.4] per million population (pmp). High-income countries (HICs) had an 80-fold higher prevalence of PD than low-income countries (LICs) (56.2 pmp vs 0.7 pmp). In 53% of countries, adults had greater PD access than children. Only 29% of countries used public funding (and free) reimbursement for PD with Oceania and South East Asia (6%), Africa (10%) and South Asia (14%) having the lowest proportions of countries in this category. Overall, the annual median cost of PD was US$18 959.2 (IQR US$10 891.4-US$31 013.8) with full private out-of-pocket payment in 4% of countries and the highest median cost in LICs (US$30 064.4) compared with other country income levels (e.g. HICs US$27 206.0). CONCLUSIONS: Ongoing large gaps and variability in the availability, access and affordability of PD across countries and world regions were observed. Of note, there is significant inequity in access to PD by children and for people in LICs.

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BACKGROUND: Radiotherapy reduces local recurrence in locally advanced rectal cancer, but may cause harm in patients who do not experience recurrence. The aim was to investigate the impact of radiotherapy on long-term quality of life after curative treatment for rectal cancer, i.e. in patients without a recurrence during the follow-up. METHODS: All patients operated on for rectal cancer in Norway under 75 years of age between 30 September 2007 and 1 October 2020 were identified using the Cancer Registry of Norway. Exclusion criteria were distant metastasis, recurrence and dementia. The primary outcome measure was the Gastrointestinal Quality of Life Index. Secondary outcome measures included the 36-item Short Form Survey. Inverse probability weights based on a multiple logistic regression model were used to balance prechosen covariates between the radiotherapy and no radiotherapy groups when assessing differences in outcomes. RESULTS: Of 5014 invited patients, 2142 (43%) eligible patients answered the questionnaires. Of these 762 (36%) were treated with neoadjuvant radiotherapy plus surgery and 1380 (64%) with surgery alone. The mean follow-up time was 6.4 and 7.4 years respectively. After propensity score matching, the Gastrointestinal Quality of Life Index differed significantly between irradiated and non-irradiated patients ((mean(s.d.), mean score 103.8(19.4) versus 110.8(19.6) respectively, mean difference: -6.96 (95% c.i. -8.72 to -5.19); P < 0.001). Among patients without a stoma the mean difference was -8.1 points, whereas it was -5.7 for patients with a stoma. The radiotherapy group also scored significantly lower in 7 of 8 36-item Short Form Survey domains compared with the surgery alone group. CONCLUSION: Long-term quality of life was significantly lower in patients without a recurrence during the follow-up who received radiotherapy compared with patients who did not. These findings warrant a critical re-evaluation of the use of radiotherapy both in traditional neoadjuvant treatment and in modern organ-preserving treatment regimens.

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Importance: US cancer diagnoses were substantially lower than expected during the COVID-19 pandemic in 2020. A national study on the extent to which rates recovered in 2021 has not yet been conducted. Objective: To examine observed vs expected cancer rate trends for January 2020 to December 2021. Design, Setting, and Participants: This cross-sectional, population-based study of cancer incidence trends used the Surveillance, Epidemiology, and End Results 22 (SEER-22) Registries Database, which covers 47.9% of the US population. Included individuals were those with an invasive cancer diagnosis reported to registries included in SEER-22 between January 1, 2000, and December 31, 2021. Exposures: Age, sex, race and ethnicity, urbanicity, and stage at diagnosis. Main Outcomes and Measures: Expected cancer incidence rates were measured for the COVID-19 pandemic years of 2020 and 2021 from prepandemic trends using ensemble forecasting methods. Relative difference between observed and expected cancer incidence rates and numbers of potentially missed cases were measured. Results: The SEER-22 registries reported 1 578 697 cancer cases in 2020 and 2021, including 798 765 among male individuals (50.6%) and 909 654 among persons aged 65 years or older (57.6%). Observed all-sites cancer incidence rates were lower than expected by 9.4% in 2020 (95% prediction interval [PI], 8.5%-10.5%), lower than expected by 2.7% in 2021 (95% PI, 1.4%-3.9%), and lower than expected by 6.0% across both years combined (95% PI, 5.1%-7.1%), resulting in 149 577 potentially undiagnosed cancer cases (95% PI, 126 059-176 970). Of the 4 screening-detected cancers, only female breast cancer showed significant recovery in 2021, exceeding expected rates by 2.5% (95% PI, 0.1%-4.8%), while significant reductions remained for lung cancer (9.1% lower than expected; 95% PI, 6.4%-13.2%) and cervical cancer (4.5% lower than expected; 95% PI, 0.4%-8.0%), particularly for early stage at diagnosis. Rates of all-sites cancer incidence returned to prepandemic trends in 2021 among female individuals, persons aged younger than 65 years, and persons of non-Hispanic Asian and Pacific Islander race and ethnicity. Conclusions and Relevance: This population-based cross-sectional study of US cancer incidence trends found that rates of diagnosis improved in 2021 but continued to be lower than expected, adding to the existing deficit of diagnosed cases from 2020. Particular attention should be directed at strategies to immediately increase cancer screenings to make up lost ground.

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INTRODUCTION: Obstetrics research has predominantly focused on the management and identification of factors associated with labor dystocia. Despite these efforts, clinicians currently lack the necessary tools to effectively predict a woman's risk of experiencing labor dystocia. Therefore, the objective of this study was to create a predictive model for labor dystocia. MATERIAL AND METHODS: The study population included nulliparous women with a single baby in the cephalic presentation in spontaneous labor at term. With a cohort-based registry design utilizing data from the Copenhagen Pregnancy Cohort and the Danish Medical Birth Registry, we included women who had given birth from 2014 to 2020 at Copenhagen University Hospital-Rigshospitalet, Denmark. Logistic regression analysis, augmented by a super learner algorithm, was employed to construct the prediction model with candidate predictors pre-selected based on clinical reasoning and existing evidence. These predictors included maternal age, pre-pregnancy body mass index, height, gestational age, physical activity, self-reported medical condition, WHO-5 score, and fertility treatment. Model performance was evaluated using the area under the receiver operating characteristics curve (AUC) for discriminative capacity and Brier score for model calibration. RESULTS: A total of 12,445 women involving 5,525 events of labor dystocia (44%) were included. All candidate predictors were retained in the final model, which demonstrated discriminative ability with an AUC of 62.3% (95% CI:60.7-64.0) and Brier score of 0.24. CONCLUSIONS: Our model represents an initial advancement in the prediction of labor dystocia utilizing readily available information obtainable upon admission in active labor. As a next step further model development and external testing across other populations is warranted. With time a well-performing model may be a step towards facilitating risk stratification and the development of a user-friendly online tool for clinicians.

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BACKGROUND: Multiple marker screening is offered to pregnant individuals in many jurisdictions to screen for trisomies 21 and 18. On occasion, the result is 'double-positive'-a screening result that is unexpectedly positive for both aneuploidies. Although this occurs rarely, the paucity of available evidence about the outcomes of these pregnancies hinders patient counselling. This study aimed to investigate the association of double-positive results with preterm birth and other adverse perinatal outcomes. METHODS: We conducted a population-based retrospective cohort study of pregnancies with an estimated date of delivery from September 1, 2016, to March 31, 2021, using province-wide perinatal registry data in Ontario, Canada. Pregnancies with double-positive screening results where trisomies 21 and 18 were ruled-out were compared to pregnancies with screen negative results for both aneuploidies. We used modified Poisson regression models with robust variance estimation to examine the association of double positive results with preterm birth and secondary outcomes. RESULTS: From 429 540 pregnancies with multiple marker screening, 863 (0.2%) had a double-positive result; trisomies 21 and 18 were ruled out in 374 pregnancies, 203 of which resulted in a live birth. Among the pregnancies in the double-positive group resulting in a live birth, the risk of preterm birth was increased compared to pregnancies with a screen negative result: adjusted risk ratio (aRR) 2.6 (95%CI 2.0-3.6), adjusted risk difference (aRD) 10.5% (95%CI 5.4-15.7). In a sensitivity analysis excluding all diagnosed chromosomal abnormalities, the risk of preterm birth remained elevated to a similar degree: aRR 2.6 (95%CI 1.9-3.7), aRD 10.0% (95%CI 4.8-15.3). The risk of other adverse perinatal outcomes was also higher, including the risk of chromosomal abnormalities other than trisomies 21 and 18: aRR 81.1 (95%CI 69.4-94.8), aRD 34.0% (95%CI 29.2-38.8). Pregnancies with double-positive results were also less likely to result in a live birth, even when excluding all diagnosed chromosomal abnormalities; and at increased risk of adverse perinatal outcomes for those resulting in a live birth. CONCLUSION: Although rare, double-positive multiple marker screening results are associated with an increased risk of preterm birth and other adverse perinatal outcomes, even when excluding all identified chromosomal abnormalities.

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