Timing and sequence of vaccination against COVID-19 and influenza (TACTIC): a single-blind, placebo-controlled randomized clinical trial.

Background: Novel mRNA-based vaccines have been used to protect against SARS-CoV-2, especially in vulnerable populations who also receive an annual influenza vaccination. The TACTIC study investigated potential immune interference between the mRNA COVID-19 booster vaccine and the quadrivalent influenza vaccine, and determined if concurrent administration would have effects on safety or immunogenicity. Methods: TACTIC was a single-blind, placebo-controlled randomized clinical trial conducted at the Radboud University Medical Centre, the Netherlands. Individuals ≥60 years, fully vaccinated against COVID-19 were eligible for participation and randomized into one of four study groups: 1) 0.5 ml influenza vaccination Vaxigrip Tetra followed by 0.3 ml BNT162b2 COVID-19 booster vaccination 21 days later, (2) COVID-19 booster vaccination followed by influenza vaccination, (3) influenza vaccination concurrent with the COVID-19 booster vaccination, and (4) COVID-19 booster vaccination only (reference group). Primary outcome was the geometric mean concentration (GMC) of IgG against the spike (S)-protein of the SARS-CoV-2 virus, 21 days after booster vaccination. We performed a non-inferiority analysis of concurrent administration compared to booster vaccines alone with a predefined non-inferiority margin of -0.3 on the log10-scale. Findings: 154 individuals participated from October, 4, 2021, until November, 5, 2021. Anti-S IgG GMCs for the co-administration and reference group were 1684 BAU/ml and 2435 BAU/ml, respectively. Concurrent vaccination did not meet the criteria for non-inferiority (estimate -0.1791, 95% CI -0.3680 to -0.009831) and antibodies showed significantly lower neutralization capacity compared to the reference group. Reported side-effects were mild and did not differ between study groups. Interpretation: Concurrent administration of both vaccines is safe, but the quantitative and functional antibody responses were marginally lower compared to booster vaccination alone. Lower protection against COVID-19 with concurrent administration of COVID-19 and influenza vaccination cannot be excluded, although additional larger studies would be required to confirm this. Trial registration number: EudraCT: 2021-002186-17. Funding: The study was supported by the ZonMw COVID-19 Programme.

A split-face comparative performance evaluation of injectable hyaluronic acid-based preparations HCC and CPM-HA20G in healthy females.

INTRODUCTION: Skin revitalizers are used for skin quality improvement purposes. Hyaluronan hybrid cooperative complexes (HCC, Profhilo®, IBSA Pharmaceuticals) are an anti-aging treatment with a large amount of pure hyaluronic acid (HA) based on stable, cooperative, and hybrid complexes. Cohesive polydensified matrix Hyaluronic Acid (CPM-HA20, Belotero Revive®, Merz Pharmaceuticals GmbH) is a slightly cross-linked HA (20 mg/ml) with glycerol (17.5 mg/ml). AIMS: To evaluate the performance of HCC and CPM-HA20G for skin quality improvement in healthy female subjects. METHODS: This was a split-face, single-blinded study that enrolled 24 healthy female subjects. Injections were given on three separate occasions. HCC was injected on the right cheek, while CPM-HA20G was injected on the left cheek. A battery of skin property measurements was used to evaluate the skin. Skin properties and overall satisfaction were analyzed using mixed models with the values at baseline, at week 1, week 8, and week 14 as an outcome and a random effect of subject and fixed effects of treatment, visit, and the treatment by visit interaction. RESULTS: Both products showed evidence of effect relative to baseline on surface hydration (AU), elasticity (N/m) TEWL (g/m2 h), and melanin (AU). CPM-HA20G also showed significant evidence of effect relative to baseline on water content (%), and HCC on pore count (n) and hemoglobin (AU). Satisfaction reported by the subjects themselves showed positive trends of satisfaction over time for multiple skin properties. There were no significant differences between the tested products in the observed skin characteristics over time. CONCLUSION: These devices are effective and safe treatments for skin quality improvement, especially moisturization, with high patient satisfaction and generally mild and transient side effects.

Outcomes after Flow Diverter Treatment in Subarachnoid Hemorrhage: A Meta-Analysis and Development of a Clinical Prediction Model (OUTFLOW).

BACKGROUND: patients with a subarachnoid hemorrhage (SAH) might need a flow diverter (FD) placement for complex acutely ruptured intracranial aneurysms (IAs). We conducted a meta-analysis and developed a prediction model to estimate the favorable clinical outcome after the FD treatment in acutely ruptured IAs. METHODS: a systematic literature search was performed from 2010 to January 2021 in PubMed and Embase databases. Studies with more than five patients treated with FDs within fifteen days were included. In total, 1157 studies were identified. The primary outcome measure was the favorable clinical outcome (mRS 0-2). Secondary outcome measures were complete occlusion rates, aneurysm rebleeding, permanent neurologic deficit caused by procedure-related complications, and all-cause mortality. A prediction model was constructed using individual patient-level data. RESULTS: 26 retrospective studies with 357 patients and 368 aneurysms were included. The pooled rates of the favorable clinical outcome, mortality, and complete aneurysm occlusion were 73.7% (95% CI 64.7-81.0), 17.1% (95% CI 13.3-21.8), and 85.6% (95% CI 80.4-89.6), respectively. Rebleeding occurred in 3% of aneurysms (11/368). The c-statistic of the final model was 0.83 (95% CI 0.76-0.89). All the studies provided a very low quality of evidence. CONCLUSIONS: FD treatment can be considered for complex ruptured IAs. Despite high complication rates, the pooled clinical outcomes seem favorable. The prediction model needs to be validated by larger prospective studies before clinical application.

NT-proBNP level before primary PCI and risk of poor myocardial reperfusion: Insight from the On-TIME II trial.

BACKGROUND: N-terminal fragment of the brain natriuretic peptide prohormone (NT-proBNP), a marker for neurohumoral activation, has been associated with adverse outcome in patients with myocardial infarction. NT-proBNP levels may reflect extensive ischemia and microvascular damage, therefore we investigated the potential association between baseline NT-proBNP level and ST-resolution (STR), a marker of myocardial reperfusion, after primary percutaneous coronary intervention (pPCI). METHODS: we performed a post-hoc analysis of the On-TIME II trial (which randomized ST-elevation myocardial infarction (STEMI) patients to pre-hospital tirofiban administration vs placebo). Patients with measured NT-proBNP before angiography were included. Multivariate logistic-regression analyses was performed to investigate the association between baseline NTproBNP level and STR one hour after pPCI. RESULTS: Out of 984 STEMI patients, 918 (93.3%) had NT-proBNP values at baseline. Patients with STR <70% had higher NT-proBNP values compared to patients with complete STR (>70%) [Mean ±SD 375.2 ±1021.7 vs 1007.4 ±2842.3, Median (IQR) 111.7 (58.4-280.0) vs 168.0 (62.3-601.3), P <.001]. At multivariate logistic regression analysis, independent predictors associated with higher risk of poor myocardial reperfusion (STR <70%) were: NT-proBNP (OR 1.17, 95%CI 1.04-1.31, P = .009), diabetes mellitus (OR 1.87, 95%CI 1.14-3.07, P = .013), anterior infarct location (OR 2.74, 95% CI 2.00-3.77, P <.001), time to intervention (OR 1.06, 95%CI 1.01-1.11, P = .021), randomisation to placebo (OR 1.45, 95%CI 1.05-1.99, P = .022). CONCLUSIONS: In STEMI patients, higher baseline NT-proBNP level was independently associate with higher risk of poor myocardial reperfusion, supporting the potential use of NT-proBNP as an early marker for risk stratification of myocardial reperfusion after pPCI in STEMI patients.

Plasma Viscosity Has a Role in the Diagnosis of Prosthetic Joint Infection After Total Knee Arthroplasty.

BACKGROUND: The diagnosis of prosthetic joint infection (PJI) is challenging because no single test has consistently demonstrated an adequate discriminative potential. The combination of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) with adequate thresholds is well established. This study sought to investigate the role of plasma viscosity (PV) in the diagnosis of PJI following painful total knee arthroplasty. METHODS: The medical notes, and hematological and microbiology results of 310 patients who underwent revision for a painful total knee arthroplasty were evaluated. Infection was confirmed using Musculoskeletal Infection Society criteria in 102 patients (32.9%), whereas 208 patients (67.1%) were classified as noninfected. Serum investigations including ESR, CRP, and PV were analyzed using receiver observer curves and optimal cutoff points identified. RESULTS: There was a strong correlation between PV and both ESR and CRP. The area under curve was 0.814 for PV and 0.812 for ESR. Statistical analysis showed noninferiority of PV as compared to ESR in diagnosing PJI. A PV value of ≥ 1.81 mPa.s. had the best efficiency of 82.1%. Combining a CRP ≥ 13.5 mg/L with a PV ≥ 1.81 mPa.s. in a serial test approach yielded the highest specificity of 97.9% and positive likelihood ratio of 22.8. Sensitivity was 47.9% and a negative likelihood ratio of 0.53. CONCLUSION: PV is noninferior to ESR in diagnosing PJI. Its use is justified in clinical practice. It is cheaper, quicker, more efficient, and not influenced by hematocrit levels or medication. In this cohort, a PV value ≥ 1.81 mPa.s. would be an adequate cutoff to diagnose PJI in combination with CRP ≥ 13.5 mg/L.

Effect of early tirofiban administration on N-terminal pro-B-type natriuretic peptide level in patients treated with primary percutaneous coronary intervention.

OBJECTIVES: To investigate the potential association between early tirofiban treatment and N-terminal pro-B-type natriuretic peptide (NT-proBNP) level after primary percutaneous coronary intervention (PCI). BACKGROUND: Whether the use of adjunctive early glycoprotein IIb/IIIa inhibitors (GPIs) therapy, may affect the level of NT-proBNP after primary PCI is poorly studied. METHODS: Nine hundred and eighty four ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI were randomized to either pre-hospital tirofiban administration or placebo. NT-proBNP levels were evaluated on admission before angiography (baseline) and 18-96 hr after PCI. RESULTS: There were 918 (93.3%) patients with NT-proBNP values available at baseline and 865 (87.9%) post-PCI. Post-PCI NT-proBNP level dichotomized with median value as cut-off (968.8 pg/mL, IQR 430.9-1970.0) was significantly lower in patients treated with early tirofiban as compared to placebo (45.5% vs. 54.2% P = 0.011). At multivariate logistic regression analysis, independent predictors of post-PCI NT-proBNP level above the median were: NT-proBNP baseline level (OR 5.19; 95% CI, 2.92-9.25, P < 0.001), Killip class>I (OR 4.07; 95% CI 1.24-13.36, P = 0.021), anterior infarct location (OR 2.61; 95% CI 1.84-3.70, P < 0.001), age (years) (OR 1.04; 95% CI 1.03-1.06, P < 0.001), male gender (OR 0.38; 95% CI 0.26-0.57, P < 0.001), prior PCI (OR 0.49; 95% CI 0.27-0.90, P = 0.021) and tirofiban administration (OR 0.71; 95% CI 0.51-0.99; P = 0.045). CONCLUSIONS: In a large cohort of STEMI patients, pre-hospital tirofiban administration was independently associate with a lower risk of high NT-proBNP level after primary PCI, supporting the potential benefit of early antithrombotic treatment administration in STEMI patients. The trial is registered under No. ISRCTN06195297.

Dental implants with fixed prosthodontics in oligodontia: A retrospective cohort study with a follow-up of up to 25 years.

STATEMENT OF PROBLEM: Long-term assessments of implant survival and treatment outcome in patients with oligodontia are lacking. PURPOSE: The purpose of this retrospective clinical study was to assess which factors determine a long-term implant survival and treatment outcome of up to 25 years in a cohort of patients with oligodontia. MATERIAL AND METHODS: The medical records of all patients with oligodontia treated with fixed implant prosthodontics between January 1991 and December 2015 in the Department of Oral and Maxillofacial Surgery at the University Medical Center Groningen, the Netherlands, were assessed. Specifically, this involved the retrieval of records on the need for and mode of bone augmentation, implant survival, and survival of and adverse events associated with the prosthodontics. The Kaplan-Meier estimator was used to analyze implant and superstructure survival. Log-rank tests were used to compare the survival of subgroups. RESULTS: A total of 126 patients with oligodontia were treated with dental implants. Of the 777 implants in total, 56 were lost, resulting in a 5-year cumulative survival of 95.7% (95% confidence interval [CI], 94.2% to 97.2%) and a 10-year cumulative survival of 89.2% (95% CI, 86.2% to 92.2%). The survival of implants placed in regions where bone augmentation surgery had been performed was significantly lower. The 5-year cumulative superstructure survival was 90.5% (95% CI, 87.6% to 93.5%), and the 10-year cumulative superstructure survival was 80.3% (95% CI, 75.3% to 85.3%). The performance of the screw-retained and cemented superstructures was comparable, but the survival of single crowns was significantly higher than the survival of fixed partial dentures (P<.001). CONCLUSIONS: Implant treatment is a predictable treatment option for patients with oligodontia with a favorable long-term outcome. Survival of implants in augmented areas is lower.

Factors associated with deferred lesion failure following fractional flow reserve assessment in patients with diabetes mellitus.

OBJECTIVE: To explore the predictors of deferred lesion failure (DLF) in patients with diabetes mellitus (DM) and lesions with a fractional flow reserve (FFR) >0.80 and to examine whether a predictive relationship between negative FFR values (>0.80-1.00) and DLF exists. BACKGROUND: DM is associated with rapidly progressive atherosclerosis and predictors of DLF in FFR negative lesions in this high-risk group are unknown. METHODS: All DM patients who underwent FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/7/2015. Patients carrying ≥1 FFR negative lesion(s) were assessed for DLF, and multivariate models used to identify independent factors associated with DLF. RESULTS: A total of 205 patients with 252 FFR >0.80 lesions were identified. At a mean follow-up of 3.1 ± 1.4 years, DLF occurred in 29/205 (14.1%) patients, 31/252 (12.3%) lesions. Using marginal Cox regression multivariate analysis, insulin requiring DM [HR 2.24 (95%CI; 1.01-4.95), P = 0.046] and prior revascularization [HR 2.70 (95%CI 1.21-6.01), P = 0.015] were identified as being associated with a higher incidence of DLF. Absolute FFR values in FFR negative lesions in DM patients are not predictive of DLF (receiver operating characteristics curve analysis: area under the curve: 0.57 ± 0.06, 95%CI 0.46-0.69). CONCLUSIONS: In DM patients with FFR negative lesions, insulin requiring DM and prior revascularization are predictors for DLF. In contrast to non-DM patients, no predictive relationship between absolute negative FFR values (ranging >0.80-1.00) and the risk of DLF exists in DM patients. © 2017 Wiley Periodicals, Inc.

Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction.

OBJECTIVE: The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ST elevation myocardial infarction (STEMI) is well studied; however, randomised data in patients with non-ST elevation myocardial infarction (NSTEMI) are lacking. The objective of this study was to investigate whether stenting with everolimus-eluting stents (EES) safely reduces restenosis in patients with NSTEMI as compared to BMS. METHODS: ELISA-3 patients were asked to participate in the angiographic substudy and were randomised to DE (Xience V) or BM (Vision) stenting (ELISA-3 group). The primary end point was minimal luminal diameter (MLD) at 9-month follow-up angiography. In addition, 296 patients with NSTEMI who were excluded or did not want to participate in the ELISA-3 trial (RELI group) were randomised to DE or BM stenting and underwent clinical follow-up only (major adverse cardiac events (MACE), stent thrombosis (ST)). A pooled analysis was performed to assess an effect on clinical outcome. RESULTS: 178 of 540 ELISA-3 patients participated in the angiographic substudy. MLD at 9 months angiography was 2.37±0.63 mm (DES) versus 1.84±0.62 mm (BMS), p<0.001. Binary restenosis occurred in 1.9% in the DES group versus 16.7% in the BMS group (RR 0.11, 95% CI 0.02 to 0.84, p=0.007). In the pooled analysis, the incidence of MACE, target vessel revascularisation and ST at 2 years follow-up in the DES versus BMS group was 12.5% versus 16.0% (p=0.28), 4.0% versus 10.4% (p=0.009) and 1.3% versus 3.0% (p=0.34), respectively. CONCLUSIONS: In patients with NSTEMI, use of EES is safe and decreases both angiographic and clinical restenosis as compared to BMS http://www.isrctn.com/search?q=39230163. TRIAL REGISTRATION NUMBER: 39230163; Post-results.

Fractional Flow Reserve-Guided Deferred Versus Complete Revascularization in Patients With Diabetes Mellitus.

To assess the safety and efficacy of deferred versus complete revascularization using a fractional flow reserve (FFR)-guided strategy in patients with diabetes mellitus (DM), we analyzed all DM patients who underwent FFR-guided revascularization from January 1, 2010, to December 12, 2013. Patients were divided into 2 groups: those with ≥1 remaining FFR-negative (>0.80) medically treated lesions [FFR(-)MT] and those with only FFR-positive lesions (≤0.80) who underwent complete revascularization [FFR(+)CR] and were followed until July 1, 2015. The primary end point was the incidence of major adverse cardiovascular events (MACE), a composite of death, myocardial infarction (MI), target lesion (FFR assessed) revascularization, and rehospitalization for acute coronary syndrome. A total of 294 patients, 205 (69.7%) versus 89 (30.3%) in FFR(-)MT and FFR(+)CR, respectively, were analyzed. At a mean follow-up of 32.6 ± 18.1 months, FFR(-)MT was associated with higher MACE rate 44.0% versus 26.6% (log-rank p = 0.02, Cox regression-adjusted hazard ratio [HR] 2.01, 95% confidence interval [CI] 1.21 to 3.33, p <0.01), and driven by both safety and efficacy end points: death/MI (HR 2.02, 95% CI 1.06 to 3.86, p = 0.03), rehospitalization for acute coronary syndrome (HR 2.06, 95% CI 1.03 to 4.10, p = 0.04), and target lesion revascularization (HR 3.38, 95% CI 1.19 to 9.64, p = 0.02). Previous MI was a strong effect modifier within the FFR(-)MT group (HR 1.98, 95% CI 1.26 to 3.13, p <0.01), whereas this was not the case in the FFR(+)CR group (HR 0.66, 95% CI 0.27 to 1.62, p = 0.37). Significant interaction for MACE was present between FFR groups and previous MI (p = 0.03). In conclusion, in patients with DM, particularly those with previous MI, deferred revascularization is associated with poor medium-term outcomes. Combining FFR with imaging techniques may be required to guide our treatment strategy in these patients with high-risk, fast-progressing atherosclerosis.

Clinical outcomes of deferred revascularisation using fractional flow reserve in patients with and without diabetes mellitus.

OBJECTIVE: Deferred revascularisation based upon fractional flow reserve (FFR >0.80) is associated with a low incidence of target lesion failure (TLF). Whether deferred revascularisation is also as safe in diabetes mellitus (DM) patients is unknown. METHODS: All DM patients and the next consecutive Non-DM patients who underwent a FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/07/2015. Patients with lesions FFR >0.80 were analysed according to the presence vs. absence of DM, while patients who underwent index revascularisation in FFR-assessed or other lesions were excluded. The primary endpoint was the incidence of TLF; a composite of target lesion revascularisation (TLR) and target vessel myocardial infarction (TVMI). RESULTS: A total of 250 patients (122 DM, 128 non-DM) who underwent deferred revascularisation of all lesions (FFR >0.80) were compared. At a mean follow up of 39.8 ± 16.3 months, DM patients compared to non-DM had a higher TLF rate, 18.1 vs 7.5 %, logrank p ≤ 0.01, Cox regression-adjusted HR 3.65 (95 % CI 1.40-9.53, p < 0.01), which was largely driven by a higher incidence of TLR (17.2 vs. 7.5 %, HR 3.52, 95 % CI 1.34-9.30, p = 0.01), whilst a non-significant but numerically higher incidence of TVMI (6.1 vs. 2.0 %, HR 3.34, 95 % CI 0.64-17.30, p = 0.15) was observed. CONCLUSIONS: This study, the largest to directly compare the clinical outcomes of FFR-guided deferred revascularisation in patients with and without DM, shows that DM patients are associated with a significantly higher TLF rate. Whether intravascular imaging, additional invasive haemodynamics or stringent risk factor modification may impact on this higher TLF rate remains unknown.

The effect of thrombus aspiration during primary percutaneous coronary intervention on clinical outcome in daily clinical practice.

It was the purpose of this study to assess the effect of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) on reperfusion and clinical outcome in a real-world STEMI population. The decision to use TA (Export catheter, Medtronic) was at the discretion of the treating cardiologist. The primary endpoint was mortality at short (in-hospital) and long term (one year) follow-up. Secondary end points were post-PCI TIMI flow, residual ST deviation and enzymatic infarct size. Cox proportional hazard models (propensity-weighted) and logistic regression analysis were used to adjust for known covariates, associated with mortality. We performed a retrospective analysis of prospectively collected data on 2,552 consecutive PPCI-treated STEMI patients between 2007 and 2010. Use of TA increased from 6.9% in 2007 to 62.2% in 2010 (p<0.001). TA was performed in 899 patients (35.2%). In-hospital and one-year mortality rates were 3.0% and 6.0%, respectively, in the TA group and 3.5% and 7.6% in the no-TA group. After multivariate analysis, TA was not significantly associated with in-hospital mortality (adjusted odds ratio [OR]: 0.70; 95% confidence interval [CI]: 0.33-1.49, p=0.36) nor one year mortality (adjusted hazard ratio [HR]: 0.75, 95%CI: 0.47-1.20, p=0.23) or cardiac mortality (HR: 0.81; 95%CI: 0.45-1.46, p=0.49). After matching on the propensity score, the HR in the TA group for one year mortality was 0.70 (95%CI: 0.41-1.20, p=0.19) and for one-year cardiac mortality 0.70 (95%CI: 0.36-1.34, p=0.28). In conclusion, no significant relationship of TA with one of the secondary end points was found. The use of TA increased over the last years but clinical outcome was similar in both groups (TA vs no-TA) in this large cohort of real-world, unselected STEMI patients.

Are antibiotics related to oral combination contraceptive failures in the Netherlands? A case-crossover study.

PURPOSE: To investigate whether there is an association between use of antibiotics and breakthrough pregnancy. METHODS: The study was performed in a population-based prescription database (IADB.nl). We computed case-crossover odds ratios of 397 cases of defined breakthrough pregnancy comparing the use of antibiotics in the exposure window with the use of antibiotics in two control windows. We defined a control group consisting of 29 022 other pregnancies. We computed case-control odds ratios of the use of antibiotics in cases as compared with controls in the different time windows. RESULTS: The case-crossover odds ratios comparing the use of antibiotics in the exposure window with both control windows were 2.21 (95%CI = 1.03-4.75) and 1.65 (95%CI = 0.78-3.48), respectively. The traditional case-control odds ratios after adjustment for age were 1.71 (95%CI = 1.09-2.66) in the exposure window, 0.81 (95%CI = 0.44-1.47) 2 months before the exposure window, and 1.04 (95%CI = 0.61-1.78) 12 months before the exposure window. CONCLUSIONS: We did find a relationship between the use of antibiotics and breakthrough pregnancy in a population-based prescription database. The results did not hold for broad-spectrum antibiotics or in a sensitivity analysis. The results are partly not the same as those found in a pharmacoepidemiological study with a similar design using two US pregnancy databases. Both studies can suffer from bias and confounding, but these will be different because of the use of different databases.

Job satisfaction and short sickness absence due to the common cold.

OBJECTIVE: This study investigated whether short episodes of sickness absence were associated with job satisfaction. PARTICIPANTS: 199 wage earners who reported sick due to the common cold between January 2003 and April 2003. METHODS: Job satisfaction was assessed on the first day of sickness absence and associated with the duration of sickness absence using a multiple logistic regression model to which demographics, working conditions, and the week day on which sick-leave was taken were stepwise added as covariates. RESULTS: Workers with low job satisfaction scores had higher odds (odds ratio [OR] =3.85; 95% confidence interval [CI] 1.74 to 8.51) of being > 3 days absent from work due to the common cold compared to satisfied workers. However, the duration of sickness absence due to the common cold was more strongly related to the day of taking sick-leave with workers who reported sick on Monday or Tuesday being longer absent (OR=5.36; 95% CI 1.44 to 9.90) than those who reported sick on Friday. CONCLUSIONS: When having a common cold, dissatisfied workers are longer absent from work although the duration of short episodes of sickness absence seems to be determined by the week day on which sick-leave is taken rather than working conditions or perceptions about work.

Recurrence of sickness absence due to common mental disorders.

PURPOSE: Common mental disorders (CMDs) are an important cause of work disability. Although CMDs are known to have high recurrence rates, little is known about the recurrence of sickness absence due to CMDs. This study examines the recurrence risk of sickness absence due to CMDs. METHODS: A cohort of 9,904 employees with a sickness absence due to CMDs, working in the Dutch Post or Telecommunication company, was studied over a 7-year period. Recurrence was defined as the start of at least one new episode of sickness absence with CMDs after complete return to work for at least 28 days. The recurrence density (RD) of sickness absence with CMDs was calculated per 1,000 person-years. RESULTS: Of the 9,904 employees with a first absence due to CMDs 1,925 (19%) had a recurrence, 90% of recurrences occurred within 3 years. The RD of sickness absence due to CMDs was 84.5 employees per 1,000 person-years (95% CI=80.7-88.3). The RD of sickness absence due to CMDs was similar in women and in men. In men, depressive symptoms were related to higher recurrence of sickness absence due to CMDs than distress symptoms and adjustment disorders. In women, no difference by diagnostic category was found. CONCLUSIONS: Employees with a previous episode of sickness absence with CMDs are at increased risk of recurrent sickness absence with CMDs. Relapse prevention consultations are recommended for a period of 3 years after return to work.

Sickness absence and full return to work after cancer: 2-year follow-up of register data for different cancer sites.

OBJECTIVE: Cancer survival has improved in recent years, but data on return to work (RTW) after cancer are sparsely published. Therefore, this study analysed RTW after cancer. METHODS: Employees diagnosed with breast cancer, genital cancer, gastro-intestinal cancer, lung cancer, skin cancer, or blood malignancies were selected from an occupational health register. Sickness absence was followed for 2 years after diagnosis and full RTW at equal earnings as before sickness absence was assessed for each cancer site using Cox proportional hazards regression analysis stratifying for age and gender. RESULTS: 3701 (73%) of 5074 employees with cancer had full RTW after a median duration of 290 days. Employees with lung cancer had the longest duration of sickness absence and only 45% of them had full RTW 2 years after diagnosis compared with 88% of employees with genital cancer and 87% of employees with skin cancer. Age was associated with the time to full RTW among employees with genital cancer: women aged≥35 years had a longer time to full RTW compared with women <35 years and men aged≥55 years had a longer time to full RTW compared with men <35 years. Gender was associated with the time to full RTW among survivors of blood malignancies with women having a longer time to full RTW than men. CONCLUSIONS: Most employees had full RTW within 2 years after the diagnosis of cancer and the time to RTW was largely independent of age and gender.

The golden hour of prehospital reperfusion with triple antiplatelet therapy: a sub-analysis from the Ongoing Tirofiban in Myocardial Evaluation 2 (On-TIME 2) trial early initiation of triple antiplatelet therapy.

BACKGROUND: It is known that the efficacy of thrombolytic therapy in ST-segment elevation myocardial infarction (STEMI) is highly time dependent with the best efficacy when given within the so-called golden hour. This analysis from the On-TIME 2 trial evaluated the efficacy of triple antiplatelet therapy on initial patency and ST-segment resolution (STR) in relation to time from symptom onset to first medical contact. METHODS: The On-TIME 2 trial included 1,398 consecutive STEMI patients referred for primary percutaneous coronary intervention (PCI). Patients were randomized to dual (500 mg aspirin and 600 mg clopidogrel) or triple antiplatelet (500 mg aspirin, 600 mg clopidogrel, and tirofiban 25 µg/kg bolus and 0.15 µg/kg per minute maintenance infusion for 18 hours) pretreatment in the ambulance. Primary outcome of this sub-analysis was initial patency of the infarct-related vessel and STR before PCI according to time from symptom onset to first medical contact in quartiles. In addition, the incidence of aborted myocardial infarction, defined as the absence of a rise in creatinine kinase, was assessed. RESULTS: Initial patency, STR before PCI, and the incidence of aborted myocardial infarction gradually increased with shorter time from symptom onset to first medical contact. Initial Thrombolysis in Myocardial Infarction flow was present in 21.2% in the total population and 26.2%, 21.5%, 18.1%, and 18.8% in the time quartiles, respectively (P for trend=.01). The incidence of complete STR pre-angiography was 16.6% in the total population and 23.4%, 18.2%, 14.7%, and 9.9% in the 4 quartiles, respectively (P for trend<.001). This was largely driven by the effect of triple antiplatelet therapy, which further improved initial patency and STR and led to a significantly higher incidence of aborted myocardial infarction (13.2% vs 8.7%, P=.011), especially in the patients with short duration of symptoms. CONCLUSION: Antiplatelet pretreatment before primary PCI, including a glycoprotein IIb/IIIa blocker, seems to be most effective when given shortly after symptom onset. Further studies should be performed to test this hypothesis.

Sick-listed employees with severe medically unexplained physical symptoms: burden or routine for the occupational health physician? A cross sectional study.

BACKGROUND: The two primary objectives of this study were to the assess consultation load of occupational health physicians (OHPs), and their difficulties and needs with regard to their sickness certification tasks in sick-listed employees with severe medical unexplained physical symptoms (MUPS). Third objective was to determine which disease-, patient-, doctor- and practice-related factors are associated with the difficulties and needs of the OHPs. METHODS: In this cross-sectional study, 43 participating OHPs from 5 group practices assessed 489 sick-listed employees with and without severe MUPS. The OHPs filled in a questionnaire about difficulties concerning sickness certification tasks, consultation time, their needs with regard to consultation with or referral to a psychiatrist or psychologist, and communication with GPs. The OHPs also completed a questionnaire about their personal characteristics. RESULTS: OHPs only experienced task difficulties in employees with severe MUPS in relation to their communication with the treating physician. This only occured in cases in which the OHP attributed the physical symptoms to somatoform causes. If they attributed the physical symptoms to mental causes, the OHPs reported a need to consultate a psychiatrist about the diagnosis and treatment. CONCLUSIONS: OHPs experience few difficulties with their sickness certification tasks and consultation load concerning employees with severe MUPS. However, they encounter problems if the diagnostic uncertainties of the treating physician interfere with the return to work process. OHPs have a need for psychiatric expertise whenever they are uncertain about the psychiatric causes of a delayed return to work process. We recommend further training programs for OHPs. They should also have more opportunity for consultation and referral to a psychiatrist, and their communication with treating physicians should be improved.

Subjective health complaints in relation to sickness absence.

OBJECTIVE: The Dutch population is healthy in terms of living and working conditions, but the levels of subjective health complaints (SHC) and sickness absence are high in the Dutch workforce. Are SHC related to sickness absence? PARTICIPANTS: The study population included the personnel of four companies: a library (n= 185), an administrative office (n=114), a cheese factory (n=201) and a company producing metal constructions (n=65). METHODS: The employees received the Basic Occupational Health Questionnaire including 22 common SHC. For each employee, the number and type of SHC but not their intensity was linked to the number of sickness absence episodes between January 2003 and December 2004. RESULTS: The questionnaires of 409 employees (72%) were suitable for statistical analysis. The prevalence of SHC in the study population was 78% between January and June 2003. Employees who reported > or = 5 SHC had higher rates of both short (1-7 days) and medium (8-42 days) sickness absence episodes. Long (> 42 days) episodes were strongly related to SHC amounting to a rate ratio (RR) of 4.2 with a 95% confidence interval [CI] 1.7 to 10.4 in workers reporting multiple SHC relative to those without complaints. Fatigue was associated with medium duration sickness absence (RR=1.6; 95% CI 1.1-2.2) and musculoskeletal complaints, particularly low back pain (RR= 1.8; 95% CI 1.2-2.8), with long episodes. CONCLUSIONS: The number of SHC was related to sickness absence. The 20% of participants reporting most SHC were responsible for about 40% of work days lost in the two-year period of study.