Development and validation of a model to predict ceiling of care in COVID-19 hospitalized patients.

BACKGROUND: Therapeutic ceiling of care is the maximum level of care deemed appropiate to offer to a patient based on their clinical profile and therefore their potential to derive benefit, within the context of the availability of resources. To our knowledge, there are no models to predict ceiling of care decisions in COVID-19 patients or other acute illnesses. We aimed to develop and validate a clinical prediction model to predict ceiling of care decisions using information readily available at the point of hospital admission. METHODS: We studied a cohort of adult COVID-19 patients who were hospitalized in 5 centres of Catalonia between 2020 and 2021. All patients had microbiologically proven SARS-CoV-2 infection at the time of hospitalization. Their therapeutic ceiling of care was assessed at hospital admission. Comorbidities collected at hospital admission, age and sex were considered as potential factors for predicting ceiling of care. A logistic regression model was used to predict the ceiling of care. The final model was validated internally and externally using a cohort obtained from the Leeds Teaching Hospitals NHS Trust. The TRIPOD Checklist for Prediction Model Development and Validation from the EQUATOR Network has been followed to report the model. RESULTS: A total of 5813 patients were included in the development cohort, of whom 31.5% were assigned a ceiling of care at the point of hospital admission. A model including age, COVID-19 wave, chronic kidney disease, dementia, dyslipidaemia, heart failure, metastasis, peripheral vascular disease, chronic obstructive pulmonary disease, and stroke or transient ischaemic attack had excellent discrimination and calibration. Subgroup analysis by sex, age group, and relevant comorbidities showed excellent figures for calibration and discrimination. External validation on the Leeds Teaching Hospitals cohort also showed good performance. CONCLUSIONS: Ceiling of care can be predicted with great accuracy from a patient's clinical information available at the point of hospital admission. Cohorts without information on ceiling of care could use our model to estimate the probability of ceiling of care. In future pandemics, during emergency situations or when dealing with frail patients, where time-sensitive decisions about the use of life-prolonging treatments are required, this model, combined with clinical expertise, could be valuable. However, future work is needed to evaluate the use of this prediction tool outside COVID-19.

Prolonged vs short-term infusion of ß-lactam antibiotics for the treatment of febrile neutropenia: A systematic review and meta-analysis.

BACKGROUND: The optimisation of the use of ß-lactam antibiotics (BLA) via prolonged infusions in life-threatening complications such as febrile neutropenia (FN) is still controversial. This systematic review and meta-analysis aim to evaluate the efficacy of this strategy in onco-haematological patients with FN. METHODS: A systematic search was performed of PubMed, Web of Science, Cochrane, EMBASE, World Health Organization, and ClinicalTrials.gov, from database inception until December 2022. The search included randomised controlled trials (RCTs) and observational studies that compared prolonged vs short-term infusions of the same BLA. The primary outcome was all-cause mortality. Secondary outcomes were defervescence, requirement of vasoactive drugs, length of hospital stay and adverse events. Pooled risk ratios were calculated using random effects models. RESULTS: Five studies were included, comprising 691 episodes of FN, mainly in haematological patients. Prolonged infusion was not associated with a reduction in all-cause mortality (pRR 0.83; 95% confidence interval 0.47-1.48). Nor differences were found in secondary outcomes. CONCLUSIONS: The limited data available did not show significant differences in terms of all-cause mortality or significant secondary outcomes in patients with FN receiving BLA in prolonged vs. short-term infusion. High-quality RCTs are needed to determine whether there are subgroups of FN patients who would benefit from prolonged BLA infusion.

Analysis of outcomes of emergency general and gastrointestinal surgery during the COVID-19 pandemic.

BACKGROUND: Few surgical studies have provided adjusted comparative postoperative outcome data among contemporary patients with and without COVID-19 infection and patients treated before the pandemic. The aim of this study was to determine the impact of performing emergency surgery in patients with concomitant COVID-19 infection. METHODS: Patients who underwent emergency general and gastrointestinal surgery from March to June 2020, and from March to June 2019 in 25 Spanish hospitals were included in a retrospective study (COVID-CIR). The main outcome was 30-day mortality. Secondary outcomes included postoperative complications and failure to rescue (mortality among patients who developed complications). Propensity score-matched comparisons were performed between patients who were positive and those who were negative for COVID-19; and between COVID-19-negative cohorts before and during the pandemic. RESULTS: Some 5307 patients were included in the study (183 COVID-19-positive and 2132 COVID-19-negative during pandemic; 2992 treated before pandemic). During the pandemic, patients with COVID-19 infection had greater 30-day mortality than those without (12.6 versus 4.6 per cent), but this difference was not statistically significant after propensity score matching (odds ratio (OR) 1.58, 95 per cent c.i. 0.88 to 2.74). Those positive for COVID-19 had more complications (41.5 versus 23.9 per cent; OR 1.61, 1.11 to 2.33) and a higher likelihood of failure to rescue (30.3 versus 19.3 per cent; OR 1.10, 0.57 to 2.12). Patients who were negative for COVID-19 during the pandemic had similar rates of 30-day mortality (4.6 versus 3.2 per cent; OR 1.35, 0.98 to 1.86) and complications (23.9 versus 25.2 per cent; OR 0.89, 0.77 to 1.02), but a greater likelihood of failure to rescue (19.3 versus 12.9 per cent; OR 1.56, 95 per cent 1.10 to 2.19) than prepandemic controls. CONCLUSION: Patients with COVID-19 infection undergoing emergency general and gastrointestinal surgery had worse postoperative outcomes than contemporary patients without COVID-19. COVID-19-negative patients operated on during the COVID-19 pandemic had a likelihood of greater failure-to-rescue than prepandemic controls.

Vertebral fractures are increased in rheumatoid arthritis despite recent therapeutic advances: a case-control study.

Prevalence and risk factors of vertebral fractures in postmenopausal RA women were assessed in 323 patients and compared with 660 age-matched women. Of patients, 24.15% had at least one vertebral fracture vs.16.06% of controls. Age, glucocorticoids and falls were the main fracture risks. Vertebral fractures were associated with disease severity. INTRODUCTION: There is little quality data on the updated prevalence of fractures in rheumatoid arthritis (RA) that may have changed due to advances in the therapeutic strategy in recent years. This study was aimed at analysing the prevalence and risk factors of vertebral fractures in postmenopausal women with RA and comparing it with that of the general population. METHODS: We included 323 postmenopausal women diagnosed with RA from 19 Spanish Rheumatology Departments, randomly selected and recruited in 2018. Lateral radiographs of the thoracic and lumbar spine were obtained to evaluate morphometric vertebral fractures and the spinal deformity index. We analysed subject characteristics, factors related to RA, and fracture risk factors. The control group consisted of 660 age-matched Spanish postmenopausal women from the population-based Camargo cohort. RESULTS: Seventy-eight (24.15%) RA patients had at least one vertebral fracture. RA patients had increased fracture risk compared with controls (106 of 660, 16.06%) (p = 0.02). Logistic regression analysis showed that age (OR 2.17; 95% CI 1.27-4.00), glucocorticoids (OR 3.83; 95% CI 1.32-14.09) and falls (OR 3.57; 95% CI 1.91-6.86) were the independent predictors of vertebral fractures in RA patients. The subgroup with vertebral fractures had higher disease activity (DAS28: 3.15 vs. 2.78, p = 0.038) and disability (HAQ: 0.96 vs. 0.63, p = 0.049), as compared with those without vertebral fractures. CONCLUSION: The risk of vertebral fracture in RA is still high in recent years, when compared with the general population. The key determinants of fracture risk are age, glucocorticoids and falls. Patients with vertebral fractures have a more severe RA.

Pragmatic, open-label, single-center, randomized, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus in patients with severe pneumonia secondary to COVID-19: The TACROVID trial protocol.

INTRODUCTION: Some COVID-19 patients evolve to severe lung injury and systemic hyperinflammatory syndrome triggered by both the coronavirus infection and the subsequent host-immune response. Accordingly, the use of immunomodulatory agents has been suggested but still remains controversial. Our working hypothesis is that methylprednisolone pulses and tacrolimus may be an effective and safety drug combination for treating severe COVID-19 patients. METHODS: and analysis: TACROVID is a randomized, open-label, single-center, phase II trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) versus SoC alone, in patients at advanced stage of COVID-19 disease with lung injury and systemic hyperinflammatory response. Patients are randomly assigned (1:1) to one of two arms (42 patients in each group). The primary aim is to assess the time to clinical stability after initiating randomization. Clinical stability is defined as body temperature ≤37.5 °C, and PaO2/FiO2 > 400 and/or SatO2/FiO2 > 300, and respiratory rate ≤24 rpm; for 48 consecutive hours. DISCUSSION: Methylprednisolone and tacrolimus might be beneficial to treat those COVID-19 patients progressing into severe pulmonary failure and systemic hyperinflammatory syndrome. The rationale for its use is the fast effect of methylprednisolone pulses and the ability of tacrolimus to inhibit both the CoV-2 replication and the secondary cytokine storm. Interestingly, both drugs are low-cost and can be manufactured on a large scale; thus, if effective and safe, a large number of patients could be treated in developed and developing countries. TRIAL REGISTRATION NUMBER: NCT04341038 / EudraCT: 2020-001445-39.

Efficacy of extended infusion of ß-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE).

BACKGROUND: Febrile neutropaenia (FN) is a very common complication in patients with haematological malignancies and is associated with considerable morbidity and mortality. Broad-spectrum antipseudomonal ß-lactam antibiotics (BLA) are routinely used for the treatment of cancer patients with FN. However, the clinical efficacy of BLA may be diminished in these patients because they present with pathophysiological variations that compromise the pharmacokinetic (PK) parameters of these antibiotics. Optimised administration of BLA in prolonged infusions has demonstrated better clinical outcomes in critically ill patients. However, there is a paucity of data on the usefulness of this strategy in patients with FN. The aim of this study is to test the hypothesis that the administration of BLA would be clinically more effective by extended infusion (EI) than by intermittent infusion (II) in haematological patients with FN. METHODS: A randomised, multicentre, open-label, superiority clinical trial will be performed. Patients with haematological malignancies undergoing chemotherapy or haematopoietic stem-cell transplant and who have FN and receive empirical antibiotic therapy with cefepime, piperacillin-tazobactam or meropenem will be randomised (1:1) to receive the antibiotic by EI (during half the time of the dosing interval) in the study group, or by II (30 min) in the control group. The primary endpoint will be clinical efficacy, defined as defervescence without modifying the antibiotic treatment administered within the first 5 days of therapy. The primary endpoint will be analysed in the intention-to-treat population. The secondary endpoints will be pharmacokinetic/pharmacodynamic (PK/PD) target achievement, bacteraemia clearance, decrease in C-reactive protein, overall (30-day) case-fatality rate, adverse events and development of a population PK model of the BLA studied. DISCUSSION: Data on the usefulness of BLA administration in patients with FN are scant. Only three clinical studies addressing this issue have been published thus far, with contradictory results. Moreover, these studies had some methodological flaws that limit the interpretation of their findings. If this randomised, multicentre, phase IV, open-label, superiority clinical trial validates the hypothesis that the administration of BLA is clinically more effective by EI than by II in haematological patients with FN, then the daily routine management of these high-risk patients could be changed to improve their outcomes. TRIAL REGISTRATION: European Clinical Trials Database: EudraCT 2018-001476-37. ClinicalTrials.gov, ID: NCT04233996.

Bemiparin as a long-term treatment for venous thrombosis in cancer patients: the ELEBAMA study.

INTRODUCTION: Low-molecular-weight heparin (LMWH) is the standard treatment for cancer-associated venous thromboembolism (VTE). There have been no specific studies evaluating bemiparin for VTE in people with cancer. The aim of this study is to evaluate the effects of bemiparin for long-term treatment of VTE in routine clinical practice. METHODS/PATIENTS: Prospective observational study. Consecutive patients with active cancer and VTE, under treatment with bemiparin for at least 6 months, were recruited. RESULTS: We included 89 patients. The 6- and 9-month cumulative VTE recurrence rates were 2.4% and 5.9%, respectively. The 6-month cumulative rate of major bleeding was 1.3%, and of clinically relevant non-major bleeding, 8%. CONCLUSIONS: The incidence of events in this study is lower than that reported in randomized trials. Bemiparin is effective and safe for the long-term treatment of cancer-associated VTE in routine clinical practice.

The association between type 2 diabetes mellitus, hip fracture, and post-hip fracture mortality: a multi-state cohort analysis.

Type 2 diabetes mellitus (T2DM) is associated with an excess risk of fractures and overall mortality. This study compared hip fracture and post-hip fracture mortality in T2DM and non-diabetic subjects. The salient findings are that subjects in T2DM are at higher risk of dying after suffering a hip fracture. INTRODUCTION: Previous research suggests that individuals with T2DM are at an excess risk of both fractures and overall mortality, but their combined effect is unknown. Using multi-state cohort analyses, we estimate the association between T2DM and the transition to hip fracture, post-hip fracture mortality, and hip fracture-free all-cause death. METHODS: Population-based cohort from Catalonia, Spain, including all individuals aged 65 to 80 years with a recorded diagnosis of T2DM on 1 January 2006; and non-T2DM matched (up to 2:1) by year of birth, gender, and primary care practice. RESULTS: A total of 44,802 T2DM and 81,233 matched controls (53% women, mean age 72 years old) were followed for a median of 8 years: 23,818 died without fracturing and 3317 broke a hip, of whom 838 subsequently died. Adjusted HRs for hip fracture-free mortality were 1.32 (95% CI 1.28 to 1.37) for men and 1.72 (95% CI 1.65 to 1.79) for women. HRs for hip fracture were 1.24 (95% CI 1.08 to 1.43) and 1.48 (95% CI 1.36 to 1.60), whilst HRs for post-hip fracture mortality were 1.28 (95% CI 1.02 to 1.60) and 1.57 (95% CI 1.31 to 1.88) in men and women, respectively. CONCLUSION: T2DM individuals are at increased risk of hip fracture, post-hip fracture mortality, and hip fracture-free death. After adjustment, T2DM men were at a 28% higher risk of dying after suffering a hip fracture and women had 57% excess risk of post-hip fracture mortality.

EUS-guided tissue acquisition in the study of the adrenal glands: Results of a nationwide multicenter study.

BACKGROUND: There are limited data about the role of endoscopic ultrasound-guided tissue acquisition (EUS-TA), by fine needle aspiration (EUS-FNA) or biopsy (EUS-FNB), in the evaluation of the adrenal glands (AG). The primary aim was to assess the diagnostic yield and safety. The secondary aims were the malignancy predictors, and to create a predictive model of malignancy. METHODS: This was a retrospective nationwide study involving all Spanish hospitals experienced in EUS-TA of AGs. Inclusion period was from April-2003 to April-2016. Inclusion criteria: all consecutive cases that underwent EUS-TA of AGs. EUS and cytopathology findings were evaluated. Statistical analyses: diagnostic accuracy of echoendoscopist's suspicion using cytology by EUS-TA, as gold standard; multivariate logistic regression model to predict tumor malignancy. RESULTS: A total of 204 EUS-TA of AGs were evaluated. Primary tumor locations were lung70%, others19%, and unknown11%. AG samples were adequate for cytological diagnosis in 91%, and confirmed malignancy in 60%. Diagnostic accuracy of the endosonographer's suspicion was 68%. The most common technique was: a 22-G (65%) and cytological needle (75%) with suction-syringe (66%). No serious adverse events were described. The variables most associated with malignancy were size>30mm (OR2.27; 95%CI, 1.16-4.05), heterogeneous echo-pattern (OR2.11; 95%CI, 1.1-3.9), variegated AG shape (OR2.46; 95%CI, 1-6.24), and endosonographer suspicion (OR17.46; 95%CI, 6.2-58.5). The best variables for a predictive multivariate logistic model of malignancy were age, sex, echo-pattern, and AG-shape. CONCLUSIONS: EUS-TA of the AGs is a safe, minimally invasive procedure, allowing an excellent diagnostic yield. These results suggest the possibility of developing a pre-EUS procedure predictive malignancy model.

Observational pilot study of patients with carpal tunnel syndrome treated with Nucleo CMP Forte™.

AIM: Carpal tunnel syndrome (CTS) is a very common entrapment neuropathy characterized by pain and paresthesia in the territory of the median nerve. Although this syndrome has a considerable impact on the patient's quality of life, its medical treatment is far from optimal. MATERIAL & METHODS: We performed an observational study to evaluate Nucleo CMP ForteTM in patients with electromyography-confirmed, mild-moderate CTS. Pain was assessed using a visual analog scale, electromyogram and the SF-36. RESULTS: Pain decreased significantly after 6 months. Quality of life improved significantly in the pain dimensions. No significant differences were observed in electromyographic findings. No adverse events were reported. CONCLUSIONS: Nucleotides could prove useful for the nonsurgical treatment of CTS. Further studies are necessary to confirm this.

Interventions to decrease short-term peripheral venous catheter-related bloodstream infections: impact on incidence and mortality.

BACKGROUND: Short-term peripheral venous catheters are a significant source of healthcare-acquired bloodstream infections and a preventable cause of death. AIM: To assess the effectiveness of interventions applied to reduce the incidence and mortality associated with short-term peripheral venous catheter-related bloodstream infections (PVCR-BSIs). METHODS: The intervention included continuous PVCR-BSI surveillance, implementation of preventive measures related to catheter insertion and maintenance in accordance with evidence-based recommendations and the hospital's own data, front-line staff educational campaigns, and assessment of adherence to hospital guidelines by ward rounds. A Poisson regression model was used to estimate the trend of rate per year. FINDINGS: From January 2003 to December 2016, 227 episodes of PVCR-BSI were identified among hospitalized patients at a university hospital. The mean age of patients was 67 years (standard deviation 14 years), 69% were male and the median Charlson score was 3 (interquartile range 2-5). Staphylococcus aureus caused 115 (50.7%) episodes. Thirty-day mortality was 13.2%. After implementation of the intervention, the incidence of PVCR-BSIs decreased significantly from 30 episodes in 2003 (1.17 episodes/10,000 patient-days) to eight episodes in 2016 (0.36/10,000 patient-days). The number of episodes caused by S. aureus decreased from 18 episodes in 2003 (0.70/10,000 patient-days) to three episodes in 2016 (0.14/10,000 patient-day), and mortality decreased from seven cases in 2003 (0.27/10,000 patient-days) to zero cases in 2016 (0.00/10,000 patient-days). CONCLUSIONS: Surveillance, implementation of a multi-modal strategy and periodical assessment of healthcare workers' adherence to hospital guidelines led to a sustained reduction in PVCR-BSIs. This reduction had a major impact on S. aureus BSI rates and associated mortality.

Clinical impact of culture-positive preservation fluid on solid organ transplantation: A systematic review and meta-analysis.

Contamination of the preservation fluid (PF) used for donated organs is a potential source of post-transplant infection. However, the information on this issue is scarce. We therefore conducted a systematic review and meta-analysis to assess the incidence of culture-positive PF and its impact on solid organ transplant (SOT) recipients. Seventeen studies were identified and included. The overall incidence of culture-positive PF was 37% (95% CI: 27% to 49%), and the incidence of PF-related infections among SOT recipients with PF cultures that grew pathogenic microorganisms was 10% (95% CI: 7% to 15%). There were differences in the rates of infections due to pathogenic microorganisms between SOT recipients who received pre-emptive treatment and those who did not, but without statistical significance. The mortality rate among SOT recipients with PF-related infection was 35% (95% CI: 21% to 53%). In conclusion, although contamination of the PF of donated organs is frequent, the incidence of PF-related infection is relatively low. A closely clinical and microbiologic monitoring of the SOT recipient in case of culture-positive PF, regardless of the type of microorganism isolated might be do in order to establish a prompt diagnosis of PF-related infection.

One and two-year persistence with different anti-osteoporosis medications: a retrospective cohort study.

Adherence to anti-osteoporosis medications is poor. We carried out a cohort study using a real-world population database to estimate the persistence of anti-osteoporosis drugs. Unadjusted 2-year persistence ranged from 10.3 to 45.4%. Denosumab users had a 40% lower risk of discontinuation at 2 years compared to alendronate users. PURPOSE: The purpose of this study was to estimate real-world persistence amongst incident users of anti-osteoporosis medications. METHODS: This is a retrospective cohort using data from anonymised records and dispensation data ( www.sidiap.org ). Eligibility comprised the following: women aged ≥50, incident users of anti-osteoporosis medication (2012), with data available for at least 12 months prior to therapy initiation. Exclusions are other bone diseases/treatments and uncommon anti-osteoporosis drugs (N < 100). Follow-up was from first pharmacy dispensation until cessation, end of study, censoring or switching. Outcomes are 2- and 1-year persistence with a permissible gap of up to 90 days. Persistence with alendronate was compared to other bisphosphonates, strontium ranelate, selective oestrogen receptor modulators, teriparatide and denosumab. Cox models were used to estimate hazard ratios of therapy cessation according to drug used after adjustment for age, sex, BMI, smoking, alcohol drinking, Charlson co-morbidity index, previous fractures, use of anti-osteoporosis medication/s, oral corticosteroids and socio-economic status. RESULTS: A total of 19,253 women were included. Unadjusted 2-year persistence [95% CI] ranged from 10.3% [9.1-11.6%] (strontium ranelate) to 45.4% [43.1-47.8%] (denosumab). One-year persistence went from 35.8% [33.9%-37.7%] (strontium ranelate) to 65.8% [63.6%-68.0%] (denosumab). At the end of the first year and compared to alendronate users, both teriparatide and denosumab users had reduced cessation risk (adjusted HR 0.76, 95% CI 0.67-0.86 and 0.54, 95% CI 0.50-0.59 respectively) while at the end of the second year, only denosumab had a lower risk of discontinuation (adjusted HR 0.60, 95% CI 0.56-0.64). CONCLUSIONS: Unadjusted 2-year persistence is suboptimal. However, both teriparatide and denosumab users had better 1-year persistence and only denosumab had 2-year better persistence compared to alendronate users. Unmeasured confounding by indication might partially explain our findings.

Clinical efficacy of ß-lactam/ß-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum ß-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR).

INTRODUCTION: Bloodstream infection (BSI) due to extended-spectrum ß-lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although ß-lactam/ß-lactamase inhibitor (BLBLI) combinations have been suggested as an alternative to carbapenems for the treatment of BSI due to these resistant organisms in the general population, their usefulness for the treatment of BSI due to ESBL-GNB in haematological patients with neutropaenia is yet to be elucidated. The aim of the BICAR study is to compare the efficacy of BLBLI combinations with that of carbapenems for the treatment of BSI due to an ESBL-GNB in this population. METHODS AND ANALYSIS: A multinational, multicentre, observational retrospective study. Episodes of BSI due to ESBL-GNB occurring in haematological patients and haematopoietic stem cell transplant recipients with neutropaenia from 1 January 2006 to 31 March 2015 will be analysed. The primary end point will be case-fatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day case-fatality rates, microbiological failure, colonisation/infection by resistant bacteria, superinfection, intensive care unit admission and development of adverse events. SAMPLE SIZE: The number of expected episodes of BSI due to ESBL-GNB in the participant centres will be 260 with a ratio of control to experimental participants of 2. ETHICS AND DISSEMINATION: The protocol of the study was approved at the first site by the Research Ethics Committee (REC) of Hospital Universitari de Bellvitge. Approval will be also sought from all relevant RECs. Any formal presentation or publication of data from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). The study has been endorsed by the European Study Group for Bloodstream Infection and Sepsis (ESGBIS) and the European Study Group for Infections in Compromised Hosts (ESGICH).

Respuesta a la carta «El registro español de artroplastias» de los Dres. M. Fernández Fairén, R. Llopis y A. Rodríguez / Response to the letter «Spanish arthoplasty register» from M. Fernández Fairén, R. Llopis and A. Rodríguez

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Incident type 2 diabetes and hip fracture risk: a population-based matched cohort study.

SUMMARY: There is scarce data on the association between early stages of type 2 diabetes and fracture risk. We report a 20% excess risk of hip fracture in the first years following disease onset compared to matched non-diabetic patients. INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a chronic disease that affects several target organs. Data on the association between T2DM and osteoporotic fractures is controversial. We estimated risk of hip fracture in newly diagnosed T2DM patients, compared to matched non-diabetic peers. METHODS: We conducted a population-based parallel cohort study using data from the Sistema d'Informació per al Desenvolupament de la Investigació en Atenció Primària (SIDIAP) database. Participants were all newly diagnosed T2DM patients registered in SIDIAP in 2006-2011 (T2DM cohort). Up to two diabetes-free controls were matched to each T2DM participant on age, gender, and primary care practice. Main outcome was incident hip fracture in 2006-2011, ascertained using the tenth edition of the International Classification of Diseases (ICD-10) codes. We used Fine and Gray survival modelling to estimate risk of hip fracture according to T2DM status, accounting for competing risk of death. Multivariate models were adjusted for body mass index, previous fracture, and use of oral corticosteroids. RESULTS: During the study period (median follow-up 2.63 years), 444/58,483 diabetic patients sustained a hip fracture (incidence rate 2.7/1,000 person-years) compared to 776/113,448 matched controls (2.4/1,000). This is equivalent to an unadjusted (age- and gender-matched) subhazard ratio (SHR) 1.11 [0.99-1.24], and adjusted SHR 1.20 [1.06-1.35]. The adjusted SHR for major osteoporotic and any osteoporotic fractures were 0.95 [0.89-1.01] and 0.97 [0.92-1.02]. CONCLUSIONS: Newly diagnosed T2DM patients are at a 20% increased risk of hip fracture even in early stages of disease, but no for all fractures. More data is needed on the causes for an increased fracture risk in T2DM patients as well as on the predictors of osteoporotic fractures among these patients.

[Arthroplasty registers as post-marketing surveillance systems: the Catalan Arthroplasty Register]. / Los registros de artroplastias como sistemas de vigilancia poscomercialización: el Registro de Artroplastias de Cataluña.

OBJECTIVE: The aim is to present the functioning and results of the Catalan Arthroplasty Registry (RACat). MATERIAL AND METHOD: The RACat arose by the initiative of the Catalan Society of Orthopaedic Surgery and Traumatology, the Catalan Health Service (CHS) and the Catalan Agency for Health Information Assessment and Quality. Publicly funded hospitals sent information through the Internet (CHS Applications website) on knee and hip arthroplasties: patient identification, hospital, joint (hip/knee), type (primary/revision), side of operation, date of surgery and prosthesis (manufacturer's name and reference number). The quality of the data is analysed regularly. We estimate the risk of replacement by the Kaplan-Meier method. RESULTS: A total of 52 hospitals out of 62 send data to RACat, and information on 36,951 knee and 26,477 hip arthroplasties is available. Data quality improved between 2005 and 2010. In 2010 coverage exceeded 70%, with side of operation 97%, and prostheses identification of 80%. The risk of replacement at three years was 3.3% (95% CI:3.1-3.6) for knee, 2.9% (95% CI:2.5-3.3) for total hip, and 2.5% (95% CI:2.0-3.1) for partial hip. DISCUSSION: Risk of replacement is higher than that observed in other registers, although data quality and its improvement over time should be taken into account. CONCLUSIONS: The information available in the RACat will help to establish a standard that will enable hospitals to compare results.

Los registros de artroplastias como sistemas de vigilancia poscomercialización: el Registro de Artroplastias de Cataluña / Arthroplasty registers as post-marketing surveillance systems: the Catalan Arthroplasty Register

Objetivo. El objetivo de este trabajo es presentar el funcionamiento y los resultados del Registro de Artroplastias de Cataluña (RACat). Material y método. El RACat surgió por iniciativa de la Sociedad Catalana de Cirugía Ortopédica y Traumatología, el Servicio Catalán de la Salud (SCS) y la Agencia de Información, Evaluación y Calidad en Salud. Los hospitales financiados públicamente envían mediante Internet (portal de aplicaciones, SCS) información sobre las artroplastias de rodilla y cadera: identificación del paciente, hospital, articulación (cadera/rodilla), tipo (primaria/recambio), lateralidad, fecha de cirugía y prótesis (fabricante y número de referencia). La calidad de los datos se analiza periódicamente. El riesgo de recambio se estima mediante el método de Kaplan-Meier. Resultados. En total 52 hospitales de 62 envían datos al RACat que dispone de información sobre 36.951 artroplastias de rodilla y 26.477 de cadera. La calidad de los datos mejoró entre 2005 y 2010, superando la cobertura el 70%, la información sobre lateralidad el 97% y la identificación de prótesis el 80%. El riesgo de recambio a los 3 años fue del 3,3% (IC 95%:3,1-3,6) para rodilla, del 2,9% (IC 95%:2,5-3,3) para las totales de cadera, y del 2,5% (IC 95%:2,0-3,1) para las parciales. Discusión. El riesgo de recambio es superior al observado en otros registros, aunque es necesario tener en cuenta la calidad de la información disponible y su mejora en el tiempo. Conclusiones. La información disponible en el RACat permitirá establecer un estándar de referencia que permita a los hospitales evaluar sus resultados (AU)

Objective. The aim is to present the functioning and results of the Catalan Arthroplasty Registry (RACat). Material and method. The RACat arose by the initiative of the Catalan Society of Orthopaedic Surgery and Traumatology, the Catalan Health Service (CHS) and the Catalan Agency for Health Information Assessment and Quality. Publicly funded hospitals sent information through the Internet (CHS Applications website) on knee and hip arthroplasties: patient identification, hospital, joint (hip/knee), type (primary/revision), side of operation, date of surgery and prosthesis (manufacturer's name and reference number). The quality of the data is analysed regularly. We estimate the risk of replacement by the Kaplan-Meier method. Results. A total of 52 hospitals out of 62 send data to RACat, and information on 36,951 knee and 26,477 hip arthroplasties is available. Data quality improved between 2005 and 2010. In 2010 coverage exceeded 70%, with side of operation 97%, and prostheses identification of 80%. The risk of replacement at three years was 3.3% (95% CI:3.1-3.6) for knee, 2.9% (95% CI:2.5-3.3) for total hip, and 2.5% (95% CI:2.0-3.1) for partial hip. Discussion. Risk of replacement is higher than that observed in other registers, although data quality and its improvement over time should be taken into account. Conclusions. The information available in the RACat will help to establish a standard that will enable hospitals to compare results (AU)

Meta-analysis of passive immunoprophylaxis in paediatric patients at risk of severe RSV infection.

AIM: To review respiratory syncytial virus (RSV), passive immunoprophylaxis (PI) trials and meta-analysis (MA). METHODS: A literature review. RESULTS: Two MA of PI were found. Overall 3927 patients were randomized. PI reduces RSV hospitalization in patients with bronchopulmonary dysplasia (RR 0.58; 95% CI 0.41, 0.82) and with acyanotic congenital heart disease (RR 0.29; 95% CI 0.14, 0.62). In patients with cyanotic heart disease or premature infants without bronchopulmonary dysplasia, results are inconclusive. Passive immunoprophylaxis has a null effect in mechanical ventilation and death. CONCLUSION: Passive immunoprophylaxis reduces RSV hospitalization in a subset of patients. However, it has no effect in harder endpoints of RSV disease severity.