A randomized placebo-controlled trial of convalescent plasma for adults hospitalized with COVID-19 pneumonia.

Passive immunotherapy with convalescent plasma may be the only available agent during the early phases of a pandemic. Here, we report safety and efficacy of high-titer convalescent plasma for COVID-19 pneumonia. Double-blinded randomized multicenter placebo-controlled trial of adult patients hospitalized with COVID-19 pneumonia. The intervention was COVID-19 convalescent plasma and placebo was saline allocated 2:1. The primary outcome was clinical status 14 days after the intervention evaluated on a clinical ordinal scale. The trial was registered at ClinicalTrials.Gov, NCT04345289, 14/04/2020. The CCAP-2 trial was terminated prematurely due to futility. Of 147 patients randomized, we included 144 patients in the modified intention-to-treat population. The ordinal clinical status 14 days post-intervention was comparable between treatment groups (odds ratio (OR) 1.41, 95% confidence interval (CI) 0.72-2.09). Results were consistent when evaluating clinical progression on an individual level 14 days after intervention (OR 1.09; 95% CI 0.46-1.73). No significant differences in length of hospital stay, admission to ICU, frequency of severe adverse events or all-cause mortality during follow-up were found between the intervention and the placebo group. Infusion of convalescent plasma did not influence clinical progression, survival or length of hospitalization in patients with COVID-19 pneumonia.

Comparable Effectiveness of Cefuroxime and Piperacillin-Tazobactam as Empirical Therapy for Methicillin-Susceptible Staphylococcus aureus Bacteremia.

Our objective was to examine whether empirical antimicrobial therapy (EAT) against methicillin-susceptible Staphylococcus aureus bacteremia (MS-SAB) with piperacillin-tazobactam (TZP), cefuroxime or combination therapy with one of these was differentially associated with 7-, 30-, and 90- day all-cause mortality or MS-SAB relapse. A multicenter retrospective cohort study of adults with MS-SAB from 2009 through 2018 was used, and 7-, 30-, 90-day mortality and relapse within 90 days were assessed and expressed as hazard ratio (HR) with a 95% confidence interval (95% CI) using Cox proportional hazard regression analysis. Matching of the two monotherapy groups was performed using propensity score matching. In total, 1158 MS-SAB cases were included and received one of three EAT regimens: TZP (n = 429), cefuroxime (n = 337), or TZP or cefuroxime with one or more additional effective antimicrobial (n = 392). The overall 30-day mortality was 28.0% (25.5 to 30.3%). After adjustment and matching, there was no significant difference in 7-, 30-, or 90-day mortality between the therapy groups. The matched HR of death was 0.81 (95% CI, 0.38 to 1.76) at 7 days, 0.82 (95% CI, 0.47 to 1.46) at 30 days, and 0.81 (95% CI, 0.50 to 1.32) at 90 days for TZP compared with cefuroxime. Adjusted HR of 90-day relapse was insignificant between the three therapy groups: TZP: 1.55 (95% CI, 0.54 to 4.43); combination therapy: 1.73 (95% CI, 0.62 to 4.80) compared to cefuroxime. There was no significant difference in 7-, 30-, or 90-day mortality or relapse between MS-SAB patients treated with empirical TZP or cefuroxime after adjustment and matching of covariables. IMPORTANCE This multicenter retrospective matched cohort study evaluated the effect of empirical antimicrobial therapy on the clinical outcome of methicillin-susceptible Staphylococcus aureus bacteremia (MS-SAB) in >1100 adult patients. To the best of our knowledge, this is the largest study to date evaluating the effect of empirical treatment on the MS-SAB outcome. Importantly, the study found no significant difference in either short- or long-term mortality nor relapse between patients with MS-SAB receiving empirical treatment with cefuroxime or piperacillin-tazobactam. As such, this study provides crucial contemporary data supporting the widespread clinical practice of initiating empirical antimicrobial therapy of sepsis with ß-lactam-ß-lactamase-inhibitor.

The Copenhagen Achilles Length Measurement Performed at Time of Acute Achilles Tendon Rupture is Correlated to Tendon Elongation After 1 Year.

Elongation of the tendon has been proposed as the most important factor leading to poor outcome after acute Achilles tendon rupture (ATR). The aim of this paper was to investigate if Amlang's ultrasound classification (AmC) or the Copenhagen Achilles Length Measurement (CALM) when assessed in the acute phase after ATR could predict elongation 1 y after rupture. 107 males and 27 females, aged 18 to 70 y and treated nonsurgically were included. AmC and CALM were assessed at time of rupture and correlated to elongation measured with CALM and Achilles Tendon Resting Angle (ATRA) at 1 y. Receiver operating characteristic (ROC) analysis was performed to determine a cut off for acceptable elongation at time of rupture given that elongation at 1 y was not to exceed 10%. AmC showed no statistically significant correlation. CALM at baseline correlated to CALM at 1 y r = 0.214 (p = .02) and ATRA at 1 y r = 0.218 (p = .02). The ROC model had AUC = 0.67 for 7% elongation at baseline yielding a sensitivity of 0.77 and specificity of 0.50 for predicting elongation of 10% or more at 1 y. Elongation of the Achilles tendon at baseline measured with CALM was weakly correlated to elongation at 1 y. A cut off of 7% elongation at baseline caught 77% of patients who, when treated nonsurgically, ended up with an elongation above 10% at 1 y. A prospective trial investigating CALM as part of a selection algorithm for deciding between operative and nonoperative treatment is needed.

Prediction of Respiratory Failure and Mortality in COVID-19 Patients Using Long Pentraxin PTX3.

The course of COVID-19 is unpredictable, ranging from asymptomatic to respiratory failure and death. Prognostic biomarkers are urgently needed. We hypothesized that long pentraxin PTX3 could be a valuable plasma biomarker due to its essential role in inflammatory processes. In a prospective hospitalized COVID-19 derivation cohort (n = 126) during the spring of 2020, we measured PTX3 within 4 days of admission. The predictive value of mechanical ventilation (MV) and 30-day mortality compared with clinical parameters and other markers of inflammation were assessed by logistic regression analysis and expressed as odds ratio (OR) with 95% confidence interval (CI). Analyses were repeated in a prospective validation cohort (n = 112) of hospitalized patients with COVID-19 treated with remdesivir and dexamethasone. Thirty-day mortality in the derivation cohort was 26.2%. In patients who died, the median PTX3 concentration upon admission was 19.5 ng/mL (IQR: 12.5-33.3) versus 6.6 ng/mL (IQR 2.9-12.3) (p < 0.0001) for survivors. After adjustment for covariates, the odds of 30-day mortality increased two-fold for each doubling of PTX3 (OR 2.03 [95% CI: 1.23-3.34], p = 0.006), which was also observed in the validation cohort (OR 1.70 [95% CI: 1.09-2.67], p = 0.02). Similarly, PTX3 levels were associated with MV. After adjustment for covariates, OR of MV was 2.34 (95% CI: 1.33-4.12, p = 0.003) in the derivation cohort and 1.64 (95% CI: 1.03-2.62, p = 0.04) in the validation cohort. PTX3 appears to be a useful clinical biomarker to predict 30-day respiratory failure and mortality risk in COVID-19 patients treated with and without remdesivir and dexamethasone.

Comorbidity Increases the Risk of Invasive Meningococcal Disease in Adults.

BACKGROUND: Risk of invasive meningococcal disease (IMD) is increased in patients with complement deficiency and human immunodeficiency virus (HIV) infection. Risk associated with comorbidity is not well described. METHODS: This was a nationwide adult case-control study. Cases for the period 1977-2018 were identified by the national meningococcus reference laboratory. Matched controls were identified by registry linkage. Comorbidities diagnosed prior to IMD were based on the International Classification of Diseases, Eighth or Tenth Revision. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated by logistic regression after adjustment for sex, age, and other comorbidities. RESULTS: We identified 1221 cases (45% male), with a median age of 45 years (interquartile range, 22-64 years). The dominant meningococcal serogroups were B (n = 738) and C (n = 337). Increased risk of IMD was associated with solid organ transplantation (SOT) (OR 40.47 [95% CI: 4.84-337.23]), hemolytic anemia (OR 7.56 [95% CI: 2.63-21.79]), renal disease (OR 2.95 [95% CI: 1.77-4.92]), liver disease (OR 2.54 [95% CI: 1.58-4.08]), cancer (OR 2.31 [95% CI: 1.85-2.89]), diabetes (OR 1.74 [95% CI: 1.27-2.39]), neurological disease (OR 1.72 [95% CI: 1.20-2.46]), and autoimmune disease (OR 1.70 [95% CI: 1.63-2.11]). Having 1, 2, and ≥3 comorbidities was associated with increased risk of IMD (ORs 1.6-3.5). Increased risk was not associated with specific serogroups. CONCLUSIONS: This study of adults with IMD over 4 decades showed increased risk of IMD associated with renal disease, immunological disorders, liver disease, cancer, and SOT ranging from a 2- to 40-fold increased risk. Vaccination may be warranted in these populations.

Nonspecific symptoms dominate at first contact to emergency healthcare services among cases with invasive meningococcal disease.

BACKGROUND: An early appropriate response is the cornerstone of treatment for invasive meningococcal disease. Little evidence exists on how cases with invasive meningococcal disease present at first contact to emergency medical services. METHODS: Retrospective observational study of cases presenting with invasive meningococcal disease from January 1st of 2016 to December 31st of 2020 in the Capital Region of Denmark with a catchment area population of 1,800,000. A single medical emergency center provides services to the region. Data was collected from emergency medical services' call audio files, data from the call receiver registrations, registrations from ambulance personal and electronic health record data from the hospitalization. RESULTS: Of 1527 cases suspected of meningitis, 38 had invasive meningococcal disease and had been in contact with the emergency service. Most contacts were to the medical helpline rather than the emergency call center at initial contact to emergency medical services. All were hospitalized within 12 h. At initial contact, fever was present in 28 (74%) of 38 cases, while specific symptoms such as headache (n=12 (32%)), a rash or petechiae (n=9 (23%)) and stiffness of the neck (n=4 (11%)) varied and were infrequent. Cases younger than 18 years of age were more often male and more often presented with fever and rash/petechiae. Only 4 (11%) received prehospital antibiotic treatment. CONCLUSIONS: Cases with invasive meningococcal disease presented with fever and unspecific symptoms. Although few were acutely ill at their initial contact, all were admitted within 12 h. We suggest that all feverish cases should be systematically asked about specific symptoms and should be wary of symptom progression to optimize the early management if cases with invasive meningococcal disease.

Recent increased incidence of invasive serogroup W meningococcal disease: A retrospective observational study.

OBJECTIVES: Neisseria meningitidis serogroup W incidence has increased. Mortality associated with serogroup W has been higher than for other serogroups. Here we report epidemiological characteristics and risks of poor outcomes associated with invasive meningococcal disease in Denmark since 1980. METHODS: All cases of invasive meningococcal disease reported from 1980-2018 were analyzed. Incidence rates by age, sex, manifestation, and serogroup were calculated. Poisson regression was used to analyze the rise in serogroup W, and multivariate logistic analysis was used to analyze risk factors for mortality. RESULTS: A total of 5825 cases were analyzed. Risk of serogroup W infection increased after 2015 compared with all previous periods. Younger (<20 years) and older age (≥60 years) was associated with an increased risk of serogroup W infection compared with being aged 20-39. Crude case fatality was 12.0%, 11.9%, 9.2%, and 7.9% for serogroups W, Y, C, and B, respectively. After adjustment for age, sex, and manifestation, 30-day mortality was comparable for serogroups. Older age and manifestation with sepsis independently predicted risk of death. CONCLUSIONS: Invasive meningococcal disease caused by serogroup W has increased, but serogroup per se was not associated with an increased risk of 30-day mortality.

Proton Pump Inhibitor Use Is Not Strongly Associated With SARS-CoV-2 Related Outcomes: A Nationwide Study and Meta-analysis.

BACKGROUND & AIMS: Proton pump inhibitor (PPI) use has been associated with increased risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and severe outcomes. However, meta-analyses show unclear results, leading to uncertainty regarding the safety of PPI use during the ongoing coronavirus disease 2019 (COVID-19) pandemic. METHODS: We conducted a nationwide observational study including all SARS-CoV-2 cases (n = 83,224) in Denmark as of December 1, 2020. The association of current PPI use with risk of infection was examined in a case-control design. We investigated the risk of severe outcomes, including mechanical ventilation, intensive care unit admission, or death, in current PPI users (n = 4473) compared with never users. Propensity score matching was applied to control for confounding. Finally, we performed an updated meta-analysis on risk of SARS-CoV-2 infection and COVID-19 mortality attributable to PPI use. RESULTS: Current PPI use was associated with increased risk of infection; adjusted odds ratio, 1.08 (95% confidence interval [CI], 1.03-1.13). Among SARS-CoV-2 cases, PPI use was associated with increased risk of hospital admission; adjusted relative risk, 1.13 (1.03-1.24), but not with other severe outcomes. The updated meta-analysis showed no association between PPI use and risk of infection or mortality; pooled odds ratio, 1.00 (95% CI, 0.75-1.32) and relative risk, 1.33 (95% CI, 0.71-2.48). CONCLUSIONS: Current PPI use may be associated with an increased risk of SARS-CoV-2 infection and hospital admission, but these results with minimally elevated estimates are most likely subject to residual confounding. No association was found for severe outcomes. The results from the meta-analysis indicated no impact of current PPI use on COVID-19 outcomes.

Comparable Outcomes of Short-Course and Prolonged-Course Therapy in Selected Cases of Methicillin-Susceptible Staphylococcus aureus Bacteremia: A Pooled Cohort Study.

BACKGROUND: The recommended duration of antimicrobial treatment for Staphylococcus aureus bacteremia (SAB) is a minimum of 14 days. We compared the clinical outcomes of patients receiving short-course (SC; 6-10 days), or prolonged-course (PC; 11-16 days) antibiotic therapy for low-risk methicillin-susceptible SAB (MS-SAB). METHODS: Adults with MS-SAB in 1995-2018 were included from 3 independent retrospective cohorts. Logistic regression models fitted with inverse probability of treatment weighting were used to assess the association between the primary outcome of 90-day mortality and treatment duration for the individual cohorts as well as a pooled cohort analysis. RESULTS: A total of 645, 219, and 141 patients with low-risk MS-SAB were included from cohorts I, II, and III. Median treatment duration in the 3 SC groups was 8 days (interquartile range [IQR], 7-10), 9 days (IQR, 8-10), and 8 days (IQR, 7-10). In the PC groups, patients received a median therapy of 14 days (IQR, 13-15), 14 days (IQR, 13-15), and 13 days (IQR, 12-15). No significant differences in 90-day mortality were observed between the SC and PC group in cohort I (odds ratio [OR], 0.85 [95% confidence interval {CI}, .49-1.41]), cohort II (OR, 1.24 [95% CI, .60-2.62]), or cohort III (OR, 1.15 [95% CI, .24-4.01]). This result was consistent in the pooled cohort analysis (OR, 1.05 [95% CI, .71-1.51]). Furthermore, duration of therapy was not associated with the risk of relapse. CONCLUSIONS: In patients with low-risk MS-SAB, shorter courses of antimicrobial therapy yielded similar clinical outcomes as longer courses of therapy.

No clinically relevant difference between operative and non-operative treatment in tendon elongation measured with the Achilles tendon resting angle (ATRA) 1 year after acute Achilles tendon rupture.

PURPOSE: Studies have shown that elongation of the injured Achilles tendon after acute Achilles tendon rupture (ATR) is negatively associated with clinical outcomes. The difference between operative and non-operative treatment on the length of the Achilles tendon is only sparsely investigated. The aim of the study was to investigate if the operative and non-operative treatment of ATR had different effects on tendon elongation. METHODS: The study was performed as a registry study in the Danish Achilles tendon database (DADB). The primary outcome of the study was an indirect measure of Achilles tendon length: the Achilles tendon resting angle (ATRA) at 1-year follow-up. The variable of interest was treatment (operative or non-operative). RESULTS: From August 2015 to January 2019, 438 patients (154 operatively treated and 284 non-operatively treated) were registered with full baseline data and had their ATRA correctly registered at 1-year follow-up in DADB. The analysis did not show a clinically relevant nor statistically significant difference in ATRA between operative and non-operatively treated patients at 1-year follow-up (mean difference - 1.2°; 95% CI - 2.5; 0.1; n.s) after adjustment for potential confounders. CONCLUSION: There were neither clinically relevant nor statistically significant differences in terms of the ATRA at 1-year follow-up between the operative and non-operatively treated patients. This finding suggests that operative treatment does not lead to a clinically relevant reduction in tendon elongation compared to non-operative treatment and it should therefore not be used as an argument in the choice of treatment. LEVEL OF EVIDENCE: Level III.

Comparable COVID-19 outcomes with current use of GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors among patients with diabetes who tested positive for SARS-CoV-2.

Incretin-based therapies, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dipeptidyl peptidase-4 inhibitors (DPP-4i), have been hypothesized to exert beneficial effects on COVID-19 outcomes due to anti-inflammatory properties. In this population-based cohort study, we retrieved data from nationwide registries on all individuals diagnosed with severe acute respiratory syndrome coronavirus 2 infection up to 1 November 2020. For individuals with diabetes, we examined the impact of use of GLP-1 RAs (n = 370) and DPP-4i (n = 284) compared with sodium-glucose cotransporter-2 inhibitors (SGLT-2i) (n = 342) on risk of hospital admission and severe outcomes. Relative risks (RRs) were calculated after applying propensity score weighted methods to control for confounding. Current users of GLP-1 RAs had an adjusted RR of 0.89 (95% confidence interval 0.34-2.33), while users of DPP-4i had an adjusted RR of 2.42 (95% confidence interval 0.99-5.89) for 30-day mortality compared with SGLT-2i use. Further, use of GLP-1 RAs or DPP-4i compared with SGLT-2i was not associated with decreased risk of hospital admission. Thus, use of incretin-based therapies in individuals with diabetes and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was not associated with improved clinical outcomes.

Diabetes and treatment with orally administrated corticosteroids negatively affect treatment outcome at follow-up after acute Achilles tendon rupture.

PURPOSE: Studies investigating the influence of comorbidities on patient-reported outcomes after acute Achilles tendon ruptures (ATR) are lacking. In this study, the aim was to investigate the effect of comorbidity and medical treatment on the patient-reported outcome measure Achilles tendon total rupture score (ATRS). METHODS: The study was performed as a registry study from the Danish Achilles tendon Database (DADB). In the DADB, ATRS was registered at baseline (prior to rupture), at 3-6 month, 1-year and 2-year follow-ups. The outcomes were ATRS at follow-up and the change in ATRS from baseline to follow-up. Variables of interest were diabetes, hypertension, rheumatic disease and treatment with orally administrated corticosteroids. Linear mixed-effects models including all follow-up time points in the same model were used adjusting for sex, age group, treatment (operative or non-operative) and the investigated comorbidities. RESULTS: Data were collected from 2012 to 2019. Two thousand and four patients with ATR were included. Patients with the investigated comorbidities and treatment with orally administrated corticosteroid scored 10.6-19.1 points lower in mean ATRS at baseline (prior to rupture) compared to patients without the respective disease or treatment. At follow-up, patients with diabetes (mean difference, [95% CI]) (- 6.2, [- 11.7; - 0.8]; P = 0.03) and patients in treatment with orally administrated corticosteroids (- 10.9, [- 16.2; - 5.7]; P < 0.01) had a statistically significantly worse ATRS than patients without the respective disease. However, change in ATRS from baseline to follow-up was not affected. Hypertension and rheumatic disease did not affect ATRS at follow-up but had a positive effect on change in ATRS (4.3, [0.5; 8.1]; P = 0.03) and (12.0, [5.0; 19.9]; P < 0.01), respectively. No other statistically significant differences were found. CONCLUSION: This study showed that patients with diabetes, hypertension, rheumatic disease and patients in treatment with orally administrated corticosteroids had a lower ATRS at baseline (prior to the rupture) when compared to patients without the respective disease or treatment. Diabetes and treatment with orally administrated corticosteroids did negatively affect ATRS at follow-up, but none of the investigated comorbidities or treatment with orally administrated corticosteroids did negatively affect change in ATRS from baseline to follow-up. LEVEL OF EVIDENCE: Level III.

Estimation of the diagnostic accuracy of real-time reverse transcription quantitative polymerase chain reaction for SARS-CoV-2 using re-analysis of published data.

INTRODUCTION: As the coronavirus disease 2019 (COVID-19) epidemic evolves and test strategies change, understanding the concepts of testing (gold standard and test performance measures) becomes essential. The challenge of any novel disease is that the gold standard has yet to be defined. METHODS: We reanalysed published data on real-time reverse transcription quantitative polymerase chain reaction (RT-qPCR) of severe acute respiratory syndrome coronavirus-2 to illustrate how predictive values vary with disease prevalence, sensitivity (set to values between 30% and 95%) and specificity (set to 99% or 99.98%). We used published data on chest CT and RT-qPCR to examine the potential of latent class analysis to estimate the sensitivity and specificity of RT-qPCR when no single gold standard exists. RESULTS: For the various sensitivity values, the negative predictive value of a RT-qPCR test remained above 92% until a COVID-19 prevalence of > 10%. The positive predictive value (PPV) was more variable. For a sensitivity of 95% and a specificity of 99%, the PPV was less-than 10% at a prevalence of 0.1%, increasing to about 90% at a prevalence of 10%. This improved to a PPV of 85% and almost 100%, respectively, when specificity increased to 99.98%. In a restricted latent class analysis, the sensitivity was 97.1% and the specificity was 99.9%, which is similar to figures from the Danish Health Authority. However, derived predictive values depended on model specification. CONCLUSIONS: A high risk of false-positives should be considered when extending the testing strategy, whereas false-negatives may occur during local outbreaks. This may have consequences for, e.g., containment strategies and research. A confirmatory test (e.g., demonstrating seroconversion or repeated RT-qPCR) may be warranted. FUNDING: none. TRIAL REGISTRATION: not relevant.

Outcome after acute Achilles tendon rupture is not negatively affected by female sex and age over 65 years.

PURPOSE: Studies suggest that women have worse treatment outcome than men after acute Achilles tendon rupture (ATR). The aim of this study was to investigate if sex and age affect treatment outcome after ATR. METHODS: The study was performed as a registry study in the Danish Achilles tendon Database. The primary outcome was change in the Achilles tendon Total Rupture Score (ATRS) from baseline to 4 months, 1 year and 2 years follow-up. Variables of interest were sex and age group (< 40 years, 40-65 years and > 65 years). RESULTS: Data were collected from April 2012 to March 2018. Five-hundred and sixteen patients (416 men, 100 women) were included in the study population. At baseline, women scored 4.3 points lower in ATRS compared to men. No statistically significant difference between the sexes regarding change in ATRS were found. Women scored statistically significantly less in absolute ATRS at 1 year follow-up (mean difference 9.4; 95% CI 3.8, 14.9; P = 0.03). Patients older than 65 years scored statistically significantly more in ATRS change compared to patients between 40-65 years (mean difference 12.8; 95% CI 6.1-19.5; P < 0.001). CONCLUSION: This study did not show a statistically significant or clinically relevant difference between the sexes in ATRS change from baseline to follow-up. The mean difference in ATRS change between patients older than 65 years and patients between 40-65 years was clinically relevant with better outcome for patients older than 65 years. When comparing ATRS between groups with an unequal sex distribution, the findings of a baseline difference and a difference in absolute ATRS at 1 year follow-up between the sexes, advocate for reporting of sex-specific data or for use of change in ATRS from baseline to follow-up instead of absolute ATRS. LEVEL OF EVIDENCE: Level III.

Children Exposed or Unexposed to Human Immunodeficiency Virus: Weight, Height, and Body Mass Index During the First 5 Years of Life-A Danish Nationwide Cohort.

BACKGROUND: Exposures to human immunodeficiency (HIV) and antiretroviral therapy in utero may have adverse effects on infant growth. Among children born in Denmark and aged 0-5 years, we aimed to compare anthropometric outcomes in HIV-exposed but uninfected (HEU) children with those in children not exposed to HIV. METHODS: In a nationwide register-based study we included all singleton HEU children born in Denmark in 2000-2016. HEU children were individually matched by child sex, parity, and maternal place of birth to 5 singleton controls born to mothers without HIV. Weight-for-age z (WAZ) scores, length-for-age z (LAZ) scores, and weight-for-length or body mass index-for-age z scores were generated according to the World Health Organization standards and the Fenton growth chart for premature infants. Differences in mean z scores were analyzed using linear mixed models, both univariate and adjusted for social and maternal factors. RESULTS: In total, 485 HEU children and 2495 HIV-unexposed controls were included. Compared with controls, HEU children were smaller at birth, with an adjusted difference in mean WAZ and LAZ scores of -0.29 (95% confidence interval [CI], -.46 to -.12) and -0.51 (95% CI, -.71 to -.31), respectively (both P ≤ .001). Over time, there was a trend toward increasing WAZ and LAZ scores in HEU children, and there was no significant difference in adjusted WAZ scores after age 14 days (-0.13 [95% CI, -.27 to .01]; P = .07) and LAZ scores after age 6 months (-0.15 [95% CI, -.32 to .02]; P = .08). CONCLUSION: Compared with a matched control group, HEU children were smaller at birth, but this difference decreased with time and is not considered to have a negative effect on the health and well-being of HEU children during early childhood.

Risk of reoperation within 12 months following osteosynthesis of a displaced femoral neck fracture is linked mainly to initial fracture displacement while risk of death may be linked to bone quality: a cohort study from Danish Fracture Database.

Background and purpose - Most guidelines use patient age as a primary decision factor when choosing between osteosynthesis or arthroplasty in displaced femoral neck fractures. We evaluate reoperation and death risk within 1 year after osteosynthesis, and estimate the influence of age, sex, degree of displacement, and bone quality.Patients and methods - All surgeries for femoral neck fractures with parallel implants (2 or 3 screws or pins) performed between December 2011 and November 2015 were collected from the Danish Fracture Database. Radiographs were analyzed for initial displacement, quality of reduction, protrusion, and angulation of implants. The bone quality was estimated using the cortical thickness index (CTI). Garden I and II type fractures with posterior tilt < 20° were excluded.Results - 654 patients with a mean age of 69 years were included. 59% were female. 54% were Garden II with posterior tilt > 20° or Garden III, and 46% were Garden IV. Only 38% were adequately reduced. 19% underwent reoperation and 18% died within 12 months. Female sex, surgical delay between 12 and 24 hours vs. < 12 hours, Garden IV type fracture, inadequate reduction, and protrusion of an implant were associated with statistically significant increased reoperation risk. No significant association between reoperation and age, CTI, or the initial angulation of implants was found. Notably, CTI was linked inversely with death risk.Interpretation - Reoperation risk is linked mainly to primary displacement and reduction of the fracture, with no apparent effect of age or bone quality. Bone quality may be linked with risk of death.

Completeness and data validity in the Danish Achilles tendon Database.

INTRODUCTION: Acute Achilles tendon rupture is a severe injury causing functional deficits and sick leave. Data from the Danish Achilles tendon Database (DADB) can help us monitor and optimise treatment. The aim of this study was to investigate the completeness and data validity in the DADB. METHODS: The study was performed as a registry study comparing data in the DADB with data from patient records. Data were collected from three of 11 hospitals registered in the DADB. The study was conducted from 1 January to 31 December 2016. A completeness of 80% was considered satisfactory, and a parameter was valid if there was agreement between the DADB and the patient record in 80% of the cases. RESULTS: Overall, completeness was 77% (155/201); for the non-operated patients 81% (150/185) and the operated patients 31% (5/16). The seven investigated parameters all showed a validity of 83-100%. CONCLUSIONS: This study documented a satisfactory completeness of data on the non-operated patients registered in the DADB and an unsatisfactory completeness of data on operated patients. All investigated parameters were valid. These results suggest that data in the DADB on non-operated patients can contribute to research within the field. Due to a limited sample on operated patients, conclusions should be made with caution. The logistics concerning data collection among operated patients warrants optimisation. FUNDING: not relevant. TRIAL REGISTRATION: The study was approved by the Danish Data Protection Agency and the Danish Patient Safety Authority.

Acceptable Success Rate in Patients With Periprosthetic Knee Joint Infection Treated With Debridement, Antibiotics, and Implant Retention.

BACKGROUND: Acute periprosthetic joint infection (PJI) following primary total knee arthroplasty (TKA) surgery can be treated with debridement, antibiotics, and implant retention (DAIR). However, varying results have been reported in the literature and optimal timing of the procedure is still debated. In this retrospective cohort study, we investigate (a) success rate of DAIR for treating PJI following primary TKA surgery and (b) whether time after primary surgery until DAIR and (c) type of isolated microorganism influence outcome. METHODS: Sixty-seven patients with PJI following primary TKA surgery treated with DAIR were identified. Patients with insufficient data and patients who did not fulfill Musculoskeletal Infection Society PJI criteria were excluded, leaving 58 patients for analysis. Minimum follow-up was 2 years. A DAIR was considered a success if the patient was infection free after 2 years. RESULTS: The overall success rate of PJI treated with DAIR was 84%. Median time until DAIR was 21 days (7-1092). Thirty-four patients (59%) were revised within 28 days, 42 patients (72%) within 42 days, while 10 patients (17%) were revised more than 90 days after primary TKA surgery. The success rates were 85%, 88%, and 60%, respectively. In the patients revised within 90 days, our success rate was 90% (43/48) regardless of the involved microorganism. CONCLUSION: We find DAIR to be a viable and safe treatment option for PJI following primary TKA surgery, when performed early after primary surgery and with the addition of a relevant postrevision antibiotic regime.

The development of multimorbidity during 16 years after diagnosis of type 2 diabetes.

OBJECTIVE: The aims of this study were to (1) quantify the development and composition of multimorbidity (MM) during 16 years following the diagnosis of type 2 diabetes and (2) evaluate whether the effectiveness of structured personal diabetes care differed between patients with and without MM. RESEARCH DESIGN AND METHODS: One thousand three hundred eighty-one patients with newly diagnosed type 2 diabetes were randomized to receive either structured personal diabetes care or routine diabetes care. Patients were followed up for 19 years in Danish nationwide registries for the occurrence of outcomes. We analyzed the prevalence and degree of MM based on 10 well-defined disease groups. The effect of structured personal care in diabetes patients with and without MM was analyzed with Cox regression models. RESULTS: The proportion of patients with MM increased from 31.6% at diabetes diagnosis to 80.4% after 16 years. The proportion of cardiovascular and gastrointestinal diseases in surviving patients decreased, while, for example, musculoskeletal, eye, and neurological diseases increased. The effect of the intervention was not different between type 2 diabetes patients with or without coexisting chronic disease. CONCLUSIONS: In general, the proportion of patients with MM increased after diabetes diagnosis, but the composition of chronic disease changed during the 16 years. We found cardiovascular and musculoskeletal disease to be the most prevalent disease groups during all 16 years of follow-up. The post hoc analysis of the intervention showed that its effectiveness was not different among patients who developed MM compared to those who continued to have diabetes alone.