Efficacy of a web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator (ACQUIRE-ICD): a randomized controlled trial.

AIMS: Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health-with a psychological intervention if needed-psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation. METHODS AND RESULTS: This national, multi-site, two-arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0-100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [B = -2.67, 95% confidence interval (CI) (-5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [B = -0.49, 95% CI (-1.19; 0.21), P = 0.17] or anxiety symptoms [B = -0.39, 95% CI (-0.96; 0.18), P = 0.18]. CONCLUSION: The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients.

Microdialysis as a tool to determine the local tissue concentration of dicloxacillin in man.

AIMS: The most common pathogen to cause postoperative infections in Denmark is Staphylococcus aureus. Despite using prophylactic antibiotics, infections are still seen. Whether the tissue concentration is above the minimal inhibitory concentration (MIC) for the pathogen is unknown. Thus, the concentration of dicloxacillin in muscle and adipose tissue was measured after intravenous administration, in healthy men. METHODS: MIC for dicloxacillin against S. aureus was determined using the broth macrodilution method. A microdialysis (MD) catheter was placed in the subcutaneous tissue of the abdomen and in the lateral vastus muscle of the thigh of six healthy male volunteers. They were given 2 g dicloxacillin intravenously. Samples from blood and MD fluid were collected. The unbound dicloxacillin was isolated from plasma. Samples were analysed with high performance liquid chromatography (HPLC). RESULTS: The maximum concentration was reached in muscle tissue after 0.5 h and in adipose tissue after 0.8 h. AUC0-6h for the dicloxacillin concentration in adipose tissue was significantly lower when compared to the unbound dicloxacillin concentration in plasma. The dicloxacillin concentration was above the MIC for sensitive S. aureus for a minimum of 2.3 h and a median of 4.1 h in muscle tissue and a minimum of 1.8 h and a median of 3.2 h in adipose tissue. CONCLUSIONS: The unbound dicloxacillin concentration in adipose and muscle tissue remained above the MIC for sensitive S. aureus, for a period sufficient for many orthopaedic procedures. Whether this is true in patients with compromised circulation remains to be investigated.

Follow-up after initial surgical treatment of soft tissue sarcomas in the extremities and trunk wall.

BACKGROUND/OBJECTIVES: Evaluation of our surveillance program for soft tissue sarcomas (STS) and borderline tumors (BT) for identification of local recurrence and lung metastases the first 2 years postoperatively. METHODS: We retrospectively assessed the medical files of all patients (n = 232) with STS and BT of the extremities and trunk wall who underwent surgery from 2010 to 2013. Two-hundred-and-thirty-two patients were included in the local recurrence study and 116 patients in the lung metastasis study. We extracted information on how local recurrence and lung metastases were detected. Kaplan-Meier survival analysis and 2 × 2-contingency table with Chi-square test were used. Local recurrence and lung metastases were analyzed separately. RESULTS: Twenty-five of 232 patients experienced local recurrence and 19 of 116 patients experienced lung metastases. Compared to clinical examination, local imaging led to a larger amount of local recurrence suspicions (37/560 vs. 8/706). Suspicions occurring on local imaging were more accurate than on clinical examination (17/37 vs. 0/8 affirmed). Local imaging identified a larger amount of local recurrence than clinical examination (17/560 vs. 0/706). Thirty-three patients suspected local recurrence themselves, 8 were affirmed. Compared to x-ray, computerized tomography (CT) led to a larger amount of lung metastasis suspicions (22/284 vs. 6/276). Suspicions occurring on CT seemed more accurate than on x-ray (15/22 vs. 2/6 affirmed). CT found a larger amount of lung metastases than x-ray (15/284 vs. 2/276). Three patients suspected lung metastases themselves, 1 was affirmed. CONCLUSION: Bi-annual local imaging and CT the first 2 years after surgery of STS detect local recurrence and lung metastases better than clinical examination and x-ray. Clinical examination and x-ray between these examinations is unnecessary. Patients' own suspicion of local recurrence and lung metastases is still important.

Substantial reduction in the number of amputations among patients with diabetes: a cohort study over 16 years.

AIMS/HYPOTHESIS: The aim of this study was to describe the trends in rates of amputation among individuals with and without diabetes. METHODS: We studied amputation rates in the County of Funen (approximately 0.5 million residents) during the period 1996-2011. Amputations were identified from the hospital administrative system, diabetes status by linkage with the Danish National Diabetes Register, and mortality and population data by extraction from Statistics Denmark. Amputation rates were analysed using proportional hazard models. We analysed the incidence of the first amputation at each level as well as the incidence of further amputations, subdivided by level of amputation. RESULTS: During the period 1996-2011, a total of 2,832 amputations were performed, of which 1,285 were among patients with diabetes and 1,547 among individuals without diabetes. Relative to persons without diabetes, patients with diabetes had an HR for below-ankle amputations (BAAs) of 14.7 for men and 7.5 for women, and for from-ankle-to-knee amputations (BKAs) of 7.6 and 8.4 for men and women, respectively. For above-knee amputations (AKAs) the numbers were 4.0 for men and 3.7 for women. We found an annual reduction in BAA rates among patients with diabetes of 9.8%, and the annual reduction in BKA for patients with diabetes was 15.1%. CONCLUSIONS/INTERPRETATION: The amputation rate in patients with diabetes is still several-fold higher than in persons without diabetes, but the improvements in diabetes care in recent years have resulted in a steady decline in amputation rates among patients with diabetes from this Danish cohort.

Study Design and Cohort Description of DEFIB-WOMEN: A National Danish Study in Patients with an ICD.

BACKGROUND: Little systematic evidence is available on potential gender differences in patients with an implantable cardioverter defibrillator (ICD) from a real-world cohort. We designed the DEFIB-WOMEN (The Utilization of Implantable Cardioverter DEFIBrillator Therapy in the Treatment of Heart Disease: Clinical and Psychological outcomes in WOMEN) study to examine gender differences on (1) patient-reported outcomes (PROs), (2) procedure- and device-related complications, and (3) ventricular tachyarrhythmia and mortality. This presents the study design and baseline characteristics of the cohort. METHODS: DEFIB-WOMEN is a national, multicenter, prospective, observational study. First-time implanted patients are asked to complete PROs at several time points. Information on baseline and follow-up characteristics are captured from patients' medical records, purpose-designed questions, and the Danish national registers. The DEFIB-WOMEN cohort is composed of 1,790 (19% women; 343/1,790) patients implanted between June 2010 and April 2013. RESULTS: Women and men differed on several demographic and clinical baseline characteristics, including on the prescription of ß-blockers, statins, angiotensin-converting enzyme inhibitors, and psychotropic agents. Although women generally had a healthier clinical profile, they reported significantly more symptoms of anxiety and depression and ICD concerns (fear of shock) as compared to men. These differences were not only statistically significant but also clinically relevant, with the magnitude of the differences in anxiety and ICD concerns being 0.44 and 0.42, respectively, as indicated by Cohen's effect size index. CONCLUSIONS: These preliminary results indicate that women with an ICD experience particularly more anxiety and ICD concerns as compared to men at the time of implant. Future results of DEFIB-WOMEN will show whether these gender differences persist and whether there are also gender differences in complications and survival.

Anxiety and depression as risk factors for ICD shocks and mortality in patients with an implantable cardioverter defibrillator - A systematic review.

OBJECTIVE: To examine associations between baseline anxiety and depression and occurrence of ICD shocks and risk of mortality in patients with an implantable cardioverter defibrillator (ICD). METHOD: We systematically searched EMBASE, PubMed, PsycINFO, and CINAHL for eligible studies fulfilling the predefined criteria. RESULTS: We included 37 studies based on 25 different cohorts following 35,003 participants for up to seven years. We observed no association between baseline anxiety nor depression and the occurrence of ICD shocks. More than half of the identified studies (respectively 56% and 60%) indicated a significant association between baseline anxiety or depression and increased risk of mortality (anxiety: n = 5, ranging from Hazard ratios (HR):1.02 [Confidence intervals (CI) 95% 1.00-1.03] to HR:3.45 [CI 95% 1.57-7.60]; depression: n = 6, ranging from HR:1.03 [CI 95% 1.00-1.06] to HR:2.10 [CI 95% 1.44-3.05]). We found a significant association between high methodological quality of the primary study and the detection of a significant association (p < 0.01). CONCLUSIONS: Baseline anxiety and depression are associated with increased risk of mortality in patients with an ICD, but not with occurrence of ICD shocks. Inclusion of baseline anxiety and depression in risk stratification of mortality may be warranted.

High level of post-traumatic stress symptoms in patients with chronic neck pain is associated with poor mental health but does not moderate the outcome of a multimodal physiotherapy programme.

INTRODUCTION: Chronic traumatic neck pain has a high prevalence of post-traumatic stress symptoms (PTSS). However, whether PTSS moderates treatment effects is unknown. This study investigated: 1) whether PTSS was associated with patient-reported outcomes and clinical test results at baseline; 2) whether PTSS moderated the effect of a multimodal physiotherapy intervention of exercise therapy and patient education; and 3) whether adherence to the intervention differed across PTSS groups. METHODS: Secondary data analysis from a randomized controlled trial on chronic neck pain with 12-month follow-up was conducted. Patients were divided into three groups (NT = non-traumatic, LT = traumatic low PTSS, HT = traumatic high PTSS) based on self-reported onset of pain and the Impact of Event Scale. The baseline data were used to analyze the association of PTSS with patient demographics and scores of physical and mental health-related quality of life, depression, neck-related disability, kinesiophobia, and clinical tests. Baseline, 4-month and 12-month follow-up data were analyzed to investigate possible moderating effects on outcomes. Data on adherence were collected at four months. RESULTS: 115 participants were included (NT n = 45; LT n = 46; HT n = 24). The HT group reported lower mental health scores and more depressive symptoms at baseline. PTSS did not significantly moderate the treatment effect on any outcomes. The HT group tended to have lower adherence to the multimodal physiotherapy intervention than the LT group. CONCLUSION: For patients with traumatic neck pain, high levels of PTSS are associated with poorer psychological outcomes but do not affect the outcomes of multimodal physiotherapy intervention.

Psychological distress in patients with an implantable cardioverter defibrillator and their partners.

OBJECTIVES: Adjustment to life with an implantable cardioverter defibrillator (ICD) may be challenging for some patients and their partners, with disease and individual characteristics likely influencing the process. We examined whether perceived social support and clinical patient characteristics are associated with change in couples' symptoms of anxiety and depression in the first year after ICD implantation, and explored whether the associations differ between patients and partners. METHOD: A cohort of consecutively implanted patients (n = 286; 21% women) and their partners completed questionnaires on social support and symptoms of anxiety and depression prior to ICD implantation and 12 months later. Information on demographic and clinical characteristics were captured from patients' medical records or purpose-designed questions. Data were analyzed using multilevel models accounting for the interdependency of scores within couples with adjustment for possible confounders. RESULTS: Higher ratings of perceived social support prior to ICD implantation were associated with greater reductions in couples' symptoms of anxiety and depression, whereas having received an ICD shock was associated with less improvement. Secondary prevention indication for ICD implantation and symptomatic heart failure were associated with less improvement in anxiety symptoms. These associations applied to both patients' and partners' levels of distress. CONCLUSION: The patient's heart disease affects both patients' and partners' psychological adjustment in the first year after ICD implantation. Interventions are warranted that address this issue not only in patients but also in partners. Targeting social support as a resource for both could be one avenue to pursue.

Relevance versus big numbers: Students' criteria for selecting scholarly references online.

This study examined the effect of the number of citations attributed to documents on third year psychology students' selection of bibliographical references. Our main assumption was that students would take high numbers of citations as accessible relevance cues and use them heuristically to facilitate decision making, potentially bypassing deeper relevance assessment based on semantic processing. Experiment 1 presented the students with a reference selection task while manipulating the number of citations attributed to references, and found that the number of citations had a strong impact on reference selection. Moreover, the effect was independent from topic familiarity and even from students' prior knowledge of what the number of citations meant. Experiment 2 used eye-tracking data to show that this "big number" effect was contingent upon the participants fixating the numbers of citations attributed to documents. Experiment 3 manipulated the semantic relevance of references to the search topic, and demonstrated that the less relevant references were 3 times more likely to be selected when they came with a high number of citations. Overall, the study shows that the number of citations significantly influences students' selections, competing with the semantic relevance of references. Implications for the teaching of online search skills are discussed. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Complications and functional outcome after fixation of distal tibia fractures with locking plate - A multicentre study.

INTRODUCTION: The aim of this study was to evaluate the proportion of complications and the functional outcome following ORIF with low-profile locking plates in patients with distal tibia fractures. METHOD: Retrospective data was retrieved using county databases, operation books, health record and X-ray images for 6 hospitals (1 level 1, 5 level 2) in the Region of Southern Denmark. Between January 2007 and April 2011 70 consecutive patients with 71 distal tibia fractures were treated with low-profile locking plate were included. The proportion of post-operative complications, classified as minor and major complications, was retrieved from electronic health records and patient interviews. Long-term functional outcome assessed by EuroQol EQ-5D-5L questionnaire, AOFAS Ankle-Hindfoot scale, and return to pre-injury job function through patient interview and examination. RESULTS: There were 32 43A, 5 43B and 34 43C-fractures, 12 open and 10 high-energy fractures. Forty-nine cases (69%) experienced complications during the follow-up time, of which 34 were minor complications and 15 were major complications. Median EQ-5D-5L index value was 0.76, median EQ VAS-score was 80, and median AOFAS score was 73. Thirty-three percent of working patients had not returned to work as a result of the fracture. CONCLUSIONS: Our study suggest that treatment of distal tibia fractures with low-profile locking plates might have a higher proportion of complications and worse functional outcome than previously reported. LEVEL OF EVIDENCE: Therapeutic level IV Case Serie.

Reconstruction of a complicated adjacent non-union of the radius and ulna using a free vascularised double-barrel fibula graft.

While the free vascularised double-barrel fibula flap has been traditionally used in the reconstruction of defects in the long bones of the lower extremities, the advantages of this type of graft can also be seen in the treatment of adjacent radial and ulnar non-unions of the forearm. The main advantage of the double-barrel fibula flap in treatment of antebrachial non-unions is that it allows for the simultaneous anatomical reconstruction of the radius and the ulna while maximising forearm functionality. In contrast to other procedures, this tailored graft also helps preserve pronation and supination of the forearm. In this article, we chronicle a case in which a microvascular osteomyocutaneous double-barrel fibula flap was used to concurrently reconstruct the radius and ulna of a patient with a severe antebrachial non-union.

Codeine plus paracetamol versus paracetamol in longer-term treatment of chronic pain due to osteoarthritis of the hip. A randomised, double-blind, multi-centre study.

This randomized, double-blind, multi-centre study was undertaken to evaluate the efficacy and safety of treatment for 4 weeks with codeine plus paracetamol versus paracetamol in relieving chronic pain due to osteoarthritis of the hip. A total of 158 outclinic patients entered the study. Eighty-three patients (mean age 66 years) were treated with codeine 60 mg plus paracetamol 1 g 3 times daily, and 75 patients (mean age 67 years) with paracetamol 1 g 3 times daily. Ibuprofen 400 mg was prescribed as rescue medication. Due to an unexpected high rate of adverse drug reactions, the study was closed before the planned 400 patients had entered. Over weeks 1-4, 87%, 64%, 61% and 52% of patients in the codeine plus paracetamol group, and 38%, 31%, 22% and 29% of patients in the paracetamol group had one or more adverse drug reactions. Significantly more patients in the codeine plus paracetamol group had adverse drug reactions in each of the 4 weeks. Nausea, dizziness, vomiting and constipation were predominant adverse reactions in the codeine plus paracetamol group. During the first week of treatment, 30 patients (36%) in the codeine plus paracetamol group and 9 (12%) in the paracetamol group dropped out. As evaluated from patients completing the first week of treatment, the pain intensity during that week compared to their baseline pain was significantly lower in the codeine plus paracetamol group than in the paracetamol group. Moreover, during the first week the paracetamol group received rescue medicine significantly more frequently. In conclusion, when evaluated after 7 days of treatment, the daily addition of codeine 180 mg to paracetamol 3 g significantly reduced the intensity of chronic pain due to osteoarthritis of the hip joint. However, several adverse drug reactions, mainly of the gastrointestinal tract, and the larger number of patients withdrawing from treatment means that the addition of such doses of codeine cannot be recommended for longer-term treatment of chronic pain in elderly patients.

Correction of congenital brachymetatarsia by gradual callus distraction.

Two children with congenital brachymetatarsia of the fourth metatarsal bone were treated by osteotomy of the metatarsal bone and bone lengthening by the Ilizarov technique. Both children were cosmetically improved.

[Injured elderly victims of bag-snatching treated at Odense University Hospital 1996-2000]. / Tilskadekomne aeldre ved tasketyveri behandlet på Odense Universitetshospital 1996-2000.

INTRODUCTION: In recent years, a number of elderly patients have been treated at the Odense University Hospital following injuries caused by bag-snatching. The aim of this study was to discover how many of elderly patients sustained such injuries. MATERIAL AND METHODS: The study comprised all inhabitants in the Odense Municipality aged 60 years or more treated at Odense University Hospital in 1996-2000 for injuries caused by bag-snatching. RESULTS: We registered 95 patients. The annual number rose significantly from 1996 to 1999 and from 1999 to 2000 it declined. The mean age was 78 years and 95% were women. Most of the injuries occurred during the daytime. Many patients were injured, because of falls as the bag-snatcher grabbed the bag and got away (74%). Fewer patients were beaten or kicked (26%). The patients were generally pedestrians (86%), and the bag-snatchers mostly pedestrians (47%) or cyclists (29%). The injuries were commonly contusions/sprains (45%) and fractures/dislocations (37%). Twenty-seven per cent were admitted to hospital with a median stay of 15 days (1-54 days). One patient died as a result of the injury. Most patients sustained minor injuries (Maxsimal abbreviated injury scale-score = 1) (62%). DISCUSSION: Over a period of years we have observed an increasing number of injuries in the elderly caused by bagsnatching. The victims often fell and fractured or dislocated a limb. More than a quarter of the victims were hospitalised.

[Economic coverage and average costs related to injuries treated in a hospital]. / Økonomisk daekningsgrad og gennemsnitlige omkostninger ved hospitalsbehandlet tilskadekomst.

INTRODUCTION: The purpose of this study was to estimate the average costs of injuries and the proportion of total (treatment + social) costs covered when including injuries treated at the hospital. MATERIAL AND METHODS: The empirical data consisted of emergency department visits (n = 29,516) from the catchment area of Odense University Hospital in 1992 for all age groups and a representative population sample (n = 1074 injuries) for the age group 15-67 years old. The costs were assessed following the "cost of illness" principles. RESULTS: The average costs per injured person varied significantly by age and were 26,119 DKK for 68+ years old, 2357 DKK for 15-67 years old, and 1528 DKK for 0-14 years old. The total direct costs for hospital treated persons were 117 million DKK, of which "injuries at home among elderly women" totalled 29% and road traffic injuries 25%. The numerical proportion of hospital treated injuries was 36% (95% CI 32-39%), but in economic terms 92% for treatment costs, and 85% when including social costs. DISCUSSION: The proportion of total regional economic costs is considerably higher (85 or 92%) than in numerical terms for hospital based registration of injuries. Future cost studies can be based on hospital data for the age group 15-67 years old for road traffic injuries. If extrapolated conservatively to all of Denmark (population approx five million) the figures indicate that an amount of approx 2.-2.5 billion DKK per year (2002 level) is spent.

[Radiation therapy for heterotopic ossification prophylaxis].

Heterotopic ossification (HO) is a well-known condition of bone formation in soft tissues due to trauma (e.g. surgery) or neurological injury, but the exact aetiology is unknown. In most cases, HO is asymptomatic, but it may cause pain, reduced mobility of joints, and loss of functioning. Various patient groups have a significant risk of developing HO after surgery and should be offered prophylactic treatment. Nonsteroidal anti-inflammatory drugs and radiotherapy are internationally accepted treatments. This review discusses the potential for radiotherapy as prophylaxis against HO.

Newly diagnosed type 1 diabetes complicated by ketoacidosis and peripheral thrombosis leading to transfemoral amputation.

Peripheral vascular thromboembolism is a rarely described complication of diabetic ketoacidosis. We report a 41-year-old otherwise healthy man admitted with ketoacidosis and ischaemia of the left foot. The patient was unsuccessfully treated with thromboendarterectomy, and the extremity was ultimately amputated. The patient had no family history of cardiovascular disease, and all blood sample analyses for hypercoagulability were negative. We recommend an increased focus on peripheral thromboembolism, when treating patients with severe ketoacidosis.

[Peroneal nerve palsy in patient with Ehlers-Danlos syndrome]. / Paralyse af nervus peroneus hos patient med Ehlers-Danlos syndrom.

Ehlers-Danlos syndrome (EDS) is a hereditary generalized connective tissue disorder characterized by skin hyperextensibility, joint hypermobility and tissue fragility. Peripheral neuropathy is described sporadically. Although the exact mechanism of the neuropathy is not well-known, excessive stretch and abnormal connective tissue support are the suggested causative agents. To our knowledge, total peroneal nerve palsy occurring in conjunction with a growth spurt has not previously been described. We describe the case of a young male patient, who developed a total unilateral peroneal palsy during a growth spurt.