Differential recurrence after laparoscopic incisional hernia repair: importance of a nationwide registry-based mesh surveillance.

BACKGROUND: Identification of suboptimal mesh products is essential to improve the outcome after hernia surgery. This study investigated whether a national clinical database combined with administrative registries may serve as a tool for postmarketing evaluation of mesh products for hernia surgery. METHODS: This was a propensity score-matched case-control cohort study comparing outcomes in patients undergoing laparoscopic incisional hernia repair with either one particular mesh or any other synthetic mesh. Data on patients registered in the Danish Ventral Hernia Database between 2010 and 2016 were combined with administrative data from the Danish National Patient Registry. The primary outcome was operation for recurrence. Secondary outcomes were 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence), and mortality after 30 and 90 days. RESULTS: In total, 740 patients who underwent repair with one particular mesh were matched with 1479 patients who received any other synthetic mesh. The rate of repair for hernia recurrence was significantly higher in the particular mesh group than in the reference group: 12·8 versus 6·3 per cent respectively (hazard ratio 2·09, 95 per cent c.i. 1·57 to 2·79; P < 0·001). Use of the particular mesh increased the risk of readmission (odds ratio (OR) 1·53, 1·16 to 2·01; P = 0·002) and reoperation for a complication (OR 1·60, 1·03 to 2·47, P = 0·030). No difference in mortality was found. CONCLUSION: Clinical registries with prospectively collected data can provide long-term surveillance of commercial mesh. Laparoscopic incisional hernia repair with one particular mesh was associated with an increased rate of short-term complications and double the risk of repair for recurrence.

ANTECEDENTES: Es esencial identificar los productos subóptimos referidos a las mallas para mejorar los resultados en la cirugía de la hernia. Este estudio analizó si un registro clínico nacional combinado con registros de bases de datos administrativos puede servir como herramienta para la evaluación post-comercialización de productos de mallas para cirugía de la hernia. MÉTODOS: Se efectuó un estudio de emparejamiento por puntaje de propensión de una cohorte de casos y controles en el que se comparaban los resultados de la malla Physiomesh® frente a cualquier otra malla sintética en pacientes sometidos a una reparación laparoscópica de una eventración. Se combinaron los datos de los pacientes del registro danés de hernia entre 2010 y 2016 con los datos administrativos del registro nacional de pacientes de Dinamarca. La variable principal fue la reintervención por recidiva. Las variables secundarias fueron el reingreso a 30 días, la reoperación a 30 días por complicaciones (excluyendo la recidiva de la hernia) y la mortalidad a 30 y 90 días. RESULTADOS: Para la reparación herniaria se utilizó la malla Physiomesh® en 740 pacientes, que se emparejaron mediante el análisis por puntaje de propensión con 1.479 pacientes en los que se colocó otra malla sintética. La reintervención por recidiva herniaria fue significativamente mayor en el grupo Physiomesh® (12,8%) que en el grupo de referencia (6,3%); cociente de riesgos instantáneos (hazard ratio, HR): 2,09 (i.c. del 95%: 1,57-2,79), P < 0,001. El riesgo de reingreso (razón de oportunidades, odds ratio, OR: 1,53, 1,16-2,01, P = 0,002)) y de reoperación por una complicación (OR: 1,60, 1,03-2,47, P = 0,030) fueron superiores en el grupo Physiomesh®. No hubo diferencia en la mortalidad. CONCLUSIÓN: Los grandes registros clínicos con datos recogidos de forma prospectiva pueden ser útiles para efectuar el seguimiento a largo plazo de una malla comercializada para garantizar la seguridad del producto y su calidad quirúrgica. La reparación laparoscópica de una eventración con la malla Physiomesh® se asociaba con un riesgo doble de recidiva y un aumento de la tasa de complicaciones a corto plazo.

Associations between blood cultures after surgery for colorectal cancer and long-term oncological outcomes.

BACKGROUND: Systemic inflammation following curative surgery for colorectal cancer may be associated with increased risk of recurrence. [Correction added on 29 November 2019, after first online publication: text amended for accuracy.] This study investigated whether a clinically suspected infection, for which blood cultures were sent within 30 days after surgery for colorectal cancer, was associated with long-term oncological outcomes. METHODS: This register-based national cohort study included all Danish residents undergoing surgery with curative intent for colorectal cancer between January 2003 and December 2013. Patients who developed recurrence or died within 180 days after surgery were not included. Associations between blood cultures taken within 30 days after primary surgery and overall survival, disease-free survival and recurrence-free survival were analysed using Cox regression models adjusted for relevant clinical confounders, including demographic data, cancer stage, co-morbidity, blood transfusion, postoperative complications and adjuvant chemotherapy. RESULTS: The study included 21 349 patients, of whom 3390 (15·9 per cent) had blood cultures taken within 30 days after surgery. Median follow-up was 5·6 years. Patients who had blood cultures taken had an increased risk of all-cause mortality (hazard ratio (HR) 1·27, 95 per cent c.i. 1·20 to 1·35; P < 0·001), poorer disease-free survival (HR 1·22, 1·16 to 1·29; P < 0·001) and higher risk of recurrence (HR 1·15, 1·07 to 1·23; P < 0·001) than patients who did not have blood cultures taken. CONCLUSION: A clinically suspected infection requiring blood cultures within 30 days of surgery for colorectal cancer was associated with poorer oncological outcomes.

ANTECEDENTES: La inflamación sistémica en el cáncer colorrectal puede asociarse con un aumento del riesgo de recidiva. En este estudio se investigó si la sospecha clínica de infección, en la que se obtuvieron cultivos de sangre periférica durante los primeros 30 días de la cirugía por cáncer colorrectal, se asociaba con los resultados oncológicos a largo plazo. MÉTODOS: Se trata de un estudio de cohortes de un registro de una base de datos nacional, que incluyía todos los sujetos residentes en Dinamarca sometidos a cirugía por cáncer colorrectal con intención curativa desde enero de 2003 a diciembre de 2013. Los pacientes con recidiva o que fallecieron durante los primeros 180 días después de la cirugía fueron excluidos. Se estimaron las asociaciones entre los cultivos de sangre periférica efectuados en los primeros 30 días tras la cirugía primaria y la supervivencia global, supervivencia libre de enfermedad y supervivencia libre de recidiva mediante modelos de regresión de Cox, ajustados por variables clínicas confusoras relevantes (incluyendo datos demográficos, estadio del cáncer, comorbilidad, transfusión de sangre, complicaciones postoperatorias y quimioterapia adyuvante). RESULTADOS: El estudio incluyó 21.349 pacientes, de los cuales en 3.390 (16%) se habían obtenido cultivos de sangre periférica durante los primeros 30 días tras la cirugía. La mediana de seguimiento fue de 5,6 años. Los pacientes en los que se había obtenido cultivos de sangre periférica presentaron un riesgo aumentado de mortalidad por cualquier causa (cociente de riesgos instantáneos, hazard ratio, HR 1,27, i.c. del 95% 1,20-1,35; P < 0.0001), peor supervivencia libre de enfermedad (HR 1,22, i.c. del 95% 1,16-1,29; P < 0,0001) y mayor riesgo de recidiva (HR 1,15, i.c. del 95% 1,07-1,23; P < 0,0001) que los pacientes en los que no se habían obtenido cultivos. CONCLUSIÓN: La presencia de una infección sospechada clínicamente para la cual se requiere obtener cultivos de sangre periférica en los primeros 30 días tras cirugía por cancer colorrectal se asoció con peores resultados oncológicos.

Chronic comorbidity in multiple sclerosis is associated with lower incomes and dissolved intimate relationships.

BACKGROUND AND PURPOSE: The social and economic consequences of comorbidity in multiple sclerosis (MS) are largely unexplored. Differences were investigated in income and in the rate of broken relationships between cases of MS with and without chronic comorbidity. METHODS: We conducted a nationwide cohort study including all incident cases of MS in Denmark with clinical MS onset between 1980 and 2005. The difference in income was investigated at MS onset and 5 and 10 years after MS onset. The difference in the rate of broken relationships was investigated in subjects who were in a relationship at MS onset or who entered a relationship after MS onset. We used logistic, multiple linear and Poisson regression analyses. RESULTS: Cases of MS with somatic comorbidity had increased odds of low incomes both 5 years {odds ratio (OR), 1.41 [95% confidence interval (CI), 1.19-1.67; P < 0.0005]} and 10 years [OR, 1.37 (95% CI, 1.17-1.60); P < 0.0005] after MS onset. The odds of a low income with psychiatric comorbidity was increased 10 years after MS onset [OR, 3.06 (95% CI, 1.47-6.37); P = 0.003]. The rate of broken relationships was increased in cases of MS with any somatic comorbidity [incidence rate ratio, 1.46 (95% CI, 1.32-1.61); P < 0.0005]. CONCLUSIONS: Our results underscore the burden of comorbidity in MS on patients, their partners and society.

No association between vitamin D levels around time of birth and later risk of developing oligo- and polyarticular juvenile idiopathic arthritis: a Danish case-cohort study.

OBJECTIVES: Basic and epidemiological studies on rheumatic autoimmune diseases have suggested an association between vitamin D levels around time of birth and disease risk. The literature on vitamin D and juvenile idiopathic arthritis (JIA) is scarce. We hypothesized that low levels of 25-hydroxyvitamin D [25(OH)D] around time of birth would be associated with increased risk of oligo- or polyarticular JIA. METHOD: We conducted a case-cohort study of validated cases diagnosed with oligo- and polyarticular JIA (1993-2012) and controls matched on date of birth. Cases and controls were born in the period 1983-2010. Cases were diagnosed using international criteria. The concentration of 25(OH)D was assessed from neonatal dried blood spot (DBS) samples using high-sensitivity liquid chromatography tandem mass spectrometry (LC-MS/MS). Odds ratios (ORs) were calculated using conditional logistic regression and a two-way analysis of variance (ANOVA) was used to test for season and birth year 25(OH)D variations. A total of 300 matched pairs were included in the statistical analyses. RESULTS: No significant association was found between levels of 25(OH)D and JIA risk in the adjusted model [OR (per 25 nmol/L increase) 1.2, 95% confidence interval (CI) 0.9-1.6, p = 0.2]. 25(OH)D levels were found to fluctuate significantly with season (p < 0.0001) and year (p < 0.0001). The median level of 25(OH)D was 34.4 nmol/L in cases and 31.5 nmol/L in controls. CONCLUSIONS: Our study does not support the hypothesis that a window of vulnerability exists around time of birth with regard to 25(OH)D levels and later JIA risk. Further studies should explore whether 25(OH)D levels during early pregnancy or infancy may influence JIA risk.

Educational achievements of children of parents with multiple sclerosis: A nationwide register-based cohort study.

Little is known about the impact of parental multiple sclerosis (MS) on offspring's educational attainment. The objective of the study was to examine educational achievements in offspring of parents with MS compared with matched children of parents without MS in a nationwide register-based cohort study. Children of all Danish-born residents with onset between 1950 and 1986 were identified by linking the Danish Multiple Sclerosis Registry with the Civil Registration System. Twins, children with MS, and emigrated persons were excluded. The reference cohort consisted of randomly drawn individuals from the Civil Registration System without parental MS matched 8:1 to the MS offspring by sex and year of birth. Information about education was linked to the cohorts from nationwide educational registries. We included 4177 children of MS parents and 33,416 reference persons. Children of MS parents achieved statistically significant higher average grades than the reference cohort in their final exam of basic school with a mean grade difference of 0.46 (95 % CI 0.22-0.69; p = 0.0002). We found no difference in achievement of educational level above basic school (OR 1.04; 95 % CI 0.98-1.10; p = 0.20). There was a trend toward more MS offspring attaining health-related educations (OR 1.10; 95 % CI 1.00-1.21; p = 0.06). In conclusion, children of MS parents showed a small advantage in grade point average in final examinations in basic school, and they more often tended toward health-related educations. This study revealed no negative consequences of parental MS on grades and highest educational level achieved.

Physical activity increases survival after heart valve surgery.

OBJECTIVES: Increased physical activity predicts survival and reduces risk of readmission in patients with coronary heart disease. However, few data show how physical activity is associated with survival and readmission after heart valve surgery. Objective were to assess the association between physical activity levels 6-12 months after heart valve surgery and (1) survival, (2) hospital readmission 18-24 months after surgery and (3) participation in exercise-based cardiac rehabilitation. METHODS: Prospective cohort study with registry data from The CopenHeart survey, The Danish National Patient Register and The Danish Civil Registration System of 742 eligible patients. Physical activity was quantified with the International Physical Activity Questionnaire and analysed using Kaplan-Meier analysis and Cox regression and logistic regression methods. RESULTS: Patients with a moderate to high physical activity level had a reduced risk of mortality (3 deaths in 289 patients, 1%) compared with those with a low physical activity level (13 deaths in 235 patients, 5.5%) with a fully adjusted HR of 0.19 (95% CI 0.05 to 0.70). In contrast, physical activity level was not associated with the risk of hospital readmission. Patients who participated in exercise-based cardiac rehabilitation (n=297) were more likely than the non-participants (n=200) to have a moderate or high physical activity level than a low physical activity level (fully adjusted OR: 1.52, 95% CI 1.03 to 2.24). CONCLUSIONS: Moderate to high levels of physical activity after heart valve surgery are positively associated with higher survival rates and participation in cardiac rehabilitation.

Patterns of finasteride use in the male populations of four Nordic countries: A cross-national drug utilization study.

Objective Finasteride 5 mg is a drug used to treat prostate hyperplasia. Little is known about its pattern of usage. This cross-national analysis of individual-level data from Denmark, Finland, Norway and Sweden was undertaken to appraise its usage and describe cross-national differences. Materials and methods Individual-level data from nationwide prescription registers in Denmark (1995-2009), Finland (1997-2010), Norway (2004-2009) and Sweden (July 2005-2011) were used to examine cross-national finasteride utilization patterns in the adult male population (≥15 years). The study presents period prevalences, incidence rates, waiting time distributions and Lorenz curves. Results During the study period, 295,620 men had at least one prescription redemption of finasteride 5 mg, and there were approximately 3 million dispensing events of finasteride prescriptions in the four Nordic countries. Different patterns of finasteride use were observed among the four Nordic countries. The period prevalence was markedly higher in Finland and Sweden than in Denmark and Norway. In 2009, period prevalences were 18.2/1000 males in Finland and 12.0/1000 males in Sweden compared to 6.7/1000 males in Norway and 4.9/1000 males in Denmark. Incidence rates of finasteride use for Finland, Norway and Sweden were about three times that for Denmark in 2008-2009. Long-term use of finasteride was found in all four Nordic countries with a high ratio between prevalent and incident users. Conclusion Despite resemblances regarding political systems and healthcare services in the Nordic countries, differences in finasteride utilization were found across Denmark, Finland, Norway and Sweden.

Increased 30-day mortality in patients with diabetes undergoing surgery for colorectal cancer.

AIM: The primary aim of the study was to determine whether preexisting diabetes is associated with increased 30-day mortality after curative resection of colorectal cancer (CRC). The association between antidiabetic treatment and 30-day mortality was also examined. METHOD: Patients diagnosed with CRC between 1 January 2003 and 31 December 2012 were identified through the Danish Colorectal Cancer Group National Clinical Database (DCCG). The Danish National Patient Register (NPR) collated all hospital contacts in Denmark and the diagnosis of diabetes was identified by combining NPR data with the use of antidiabetic drugs identified through the Danish National Prescription Registry and DCCG. The 30-day mortality was examined by the Kaplan-Meier method with the log-rank test and the Cox regression model used to test statistical significance. RESULTS: The study included 29 353 patients, of whom 3250 had preexisting diabetes. The 30-day mortality was significantly increased in patients with CRC and preexisting diabetes (adjusted hazard ratio 1.17, 95% CI 1.01-1.35, P = 0.03). The type of antidiabetic medication used was not associated with 30-day mortality. CONCLUSION: Preexisting diabetes was associated with a higher short-term mortality in patients with CRC. No association between the type of antidiabetic medication and short-term mortality could be shown.

Exercise-based cardiac rehabilitation after heart valve surgery: cost analysis of healthcare use and sick leave.

BACKGROUND: Owing to a lack of evidence, patients undergoing heart valve surgery have been offered exercise-based cardiac rehabilitation (CR) since 2009 based on recommendations for patients with ischaemic heart disease in Denmark. The aim of this study was to investigate the impact of CR on the costs of healthcare use and sick leave among heart valve surgery patients over 12 months post surgery. METHODS: We conducted a nationwide survey on the CR participation of all patients having undergone valve surgery between 1 January 2011 and 30 June 2011 (n=667). Among the responders (n=500, 75%), the resource use categories of primary and secondary healthcare, prescription medication and sick leave were analysed for CR participants (n=277) and non-participants (n=223) over 12 months. A difference-in-difference analysis was undertaken. All estimates were presented as the means per patient (95% CI) based on non-parametric bootstrapping of SEs. RESULTS: Total costs during the 12 months following surgery were €16 065 per patient (95% CI 13 730 to 18 399) in the CR group and €15 182 (12 695 to 17 670) in the non-CR group. CR led to 5.6 (2.9 to 8.3, p<0.01) more outpatient visits per patient. No statistically significant differences in other cost categories or total costs €1330 (-4427 to 7086, p=0.65) were found between the groups. CONCLUSIONS: CR, as provided in Denmark, can be considered cost neutral. CR is associated with more outpatient visits, but CR participation potentially offsets more expensive outpatient visits. Further studies should investigate the benefits of CR to heart valve surgery patients as part of a formal cost-utility analysis.

High readmission rate after heart valve surgery: A nationwide cohort study.

BACKGROUND: After heart valve surgery, knowledge on long-term self-reported health status and readmission is lacking. Thus, the optimal strategy for out-patient management after surgery remains unclear. METHODS: Using a nationwide survey with linkage to Danish registers with one year follow-up, we included all adults 6-12 months after heart valve surgery irrespective of valve procedure, during Jan-June 2011 (n = 867). Participants completed a questionnaire regarding health-status (n = 742), and answers were compared with age- and sex-matched healthy controls. Readmission rates and mortality were investigated. RESULTS: After valve surgery, the self-reported health was lower (Short Form-36 (SF-36) Physical Component Scale (PCS): 44.5 vs. 50.6 and Mental Component Scale (MCS): 51.9 vs. 55.0, p < 0.0001) and more were physically sedentary compared with healthy controls (11.1% vs. 15.2%). Clinical signs of anxiety and depression were present in 13.6% and 13.8%, respectively (Hospital Anxiety and Depression Scale score ≥ 8). Twelve months following discharge, 483 persons (56%) were readmitted. Readmission was associated with lower self-reported health (SF-36 PCS: 46.5 vs. 43.9, and MCS 52.2 vs. 50.7). Higher age (hazard ratio (95% CI): 1.3 (1.0-1.6)), male sex (1.2 (1.0-1.5)), mitral valve surgery (1.3 (1.0-1.6)), and infective endocarditis after surgery (1.8 (1.1-3.0), p: 0.01) predicted readmission, whereas higher age (2.3 (1.0-5.4)), higher comorbidity score (3.2 (1.8-6.0)), and infective endocarditis after surgery (3.2 (1.2-8.9)) predicted mortality. CONCLUSIONS: 6-12 months after heart valve surgery the readmission rate is high and the self-reported health status is low. Readmission is associated with low self-reported health. Therefore, targeted follow-up strategies post-surgery are needed.

Comparing tailored and untailored text messages for smoking cessation: a randomized controlled trial among adolescent and young adult smokers.

The aim was to compare the effectiveness of untailored text messages for smoking cessation to tailored text messages delivered at a higher frequency. From February 2007 to August 2009, 2030 users of an internet-based smoking cessation program with optional text message support aged 15-25 years were consecutively randomized to versions of the program that offered either tailored or untailored text messages. Thirty-day point abstinence from smoking was measured self-reportedly at 12-months follow-up. Response rates were 36.3% and 38.1% in the tailored and untailored group, respectively. We analyzed the entire study population, as well as those opting for text messages (n = 1619). In intention-to-treat analysis with multiple imputation of missing data, the odds ratio for 30-day point abstinence was 1.28 (95% CI 0.91-2.08) for the tailored compared with untailored messages. When restricting the analysis to those who had chosen to receive text messages, the corresponding odds ratio was 1.45 (95% CI 1.01-2.08). The higher long-term quit rates in the group receiving the tailored text messages compared with untailored text messages in the restricted analysis indicated that tailoring and higher frequency of text messages increases quit rates among young smokers.

Evaluating the use and limitations of the Danish National Patient Register in register-based research using an example of multiple sclerosis.

BACKGROUND: The Danish National Patient Register, Landspatientregistret (LPR), is a register of all hospital discharges and outpatient treatments in Denmark. AIMS: It is increasingly used in research so it is important to understand to what extent this can be used as an accurate source of information. Virtually all patients in Denmark with multiple sclerosis (MS) are reported to the Combined MS Registry (DMSR), so this was used as the standard which the LPR was compared against. METHODS: All residents of Denmark are assigned a unique Civil Register (CPR) number; this was used to compare data between registers. The LPR completeness was estimated by the proportion of cases from the DMSR that could be retrieved from the LPR. The LPR validity was estimated by the proportion of cases, listed in the LPR and DMSR, in whom the MS diagnosis could be confirmed as definite/probable/possible by the DMSR. RESULTS: We found that 86.9% of those who were DMSR listed with an approved MS diagnosis were also listed in the LPR with a MS diagnosis. The diagnosis was valid in 96.3% of patients listed in the LPR when compared against the DMSR. CONCLUSIONS: The low completeness reduces the usefulness of the LPR in epidemiological MS research, in particular incidence studies. The study also found that the completeness of the LPR could be increased to 92.8% by including LPR records from other departments in addition, but this reduced the validity of the LPR to 95.1%. However, these results cannot uncritically be applied to registration of other diseases in the LPR.