The SOFIA pilot trial: a cluster-randomized trial of coordinated, co-produced care to reduce mortality and improve quality of life in people with severe mental illness in the general practice setting.

BACKGROUND: People with severe mental illness (SMI) have an increased risk of premature mortality, predominantly due to somatic health conditions. Evidence indicates that primary and tertiary prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility of a coordinated co-produced care program (SOFIA model, a Danish acronym for Severe Mental Illness and Physical Health in General Practice) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. METHODS: The SOFIA pilot trial is designed as a cluster randomized controlled trial targeting general practices in two regions in Denmark. We aim to include 12 practices, each of which is instructed to recruit up to 15 community-dwelling patients aged 18 and older with SMI. Practices will be randomized by a computer in a ratio of 2:1 to deliver a coordinated care program or usual care during a 6-month study period. A randomized algorithm is used to perform randomization. The coordinated care program includes educational training of general practitioners and their clinical staff educational training of general practitioners and their clinical staff, which covers clinical and diagnostic management and focus on patient-centered care of this patient group, after which general practitioners will provide a prolonged consultation focusing on individual needs and preferences of the patient with SMI and a follow-up plan if indicated. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Assessments of the outcome parameters will be administered at baseline, throughout, and at end of the study period. DISCUSSION: If necessary the intervention will be revised based on results from this study. If delivery of the intervention, either in its current form or after revision, is considered feasible, a future, definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place. Successful implementation of the intervention would imply preliminary promise for addressing health inequities in patients with SMI. TRIAL REGISTRATION: The trial was registered in Clinical Trials as of November 5, 2020, with registration number NCT04618250 . Protocol version: January 22, 2021; original version.

Pre-test probability of urinary tract infection in dogs with clinical signs of lower urinary tract disease.

Clinical signs of lower urinary tract disease in dogs are characteristic but non-specific for infection. It has been hypothesized that age, sex and neuter status influences the prevalence of urinary tract infection (UTI), but the predictive value of the combined clinical presentation has not been explored in dogs. The aim of the study was to assess clinical predictors (sex/neuter status, age, dysuria/stranguria, pollakiuria, macroscopic hematuria, malodorous urine and history of recurrent UTI) for bacterial cystitis, and to develop a clinical decision rule. Data was retrieved from medical records (retrospective cases) or from standardized recording sheets (prospective cases). Bacterial cystitis was defined as significant bacteriuria on quantitative bacterial culture in dogs with compatible clinical signs of urinary tract disease. Dogs of any breed, sex and age were included. A total of 1727 microbiology records were screened and 424 samples were included in the analysis. Bacterial cystitis was confirmed in 46% of the cases. Four variables predicted bacterial cystitis: sex/neuter status, age, pollakiuria and hematuria. A score was designated to each variable and a clinical rule was constructed. This rule attained an AUC of 0.75 and had sensitivity of 83% and specificity of 55% at its optimal cut-off (score ≥2.0). A score cut-off of ≥3.0 had a positive predictive value of 70%. Several factors predicted bacterial cystitis, but the clinical rule had only modest predictive value. Other variables or point-of-care test results should be included in future research to optimize overall precision.

Multimorbidity and mortality: A 15-year longitudinal registry-based nationwide Danish population study.

BACKGROUND: Knowledge about prevalent and deadly combinations of multimorbidity is needed. OBJECTIVE: To determine the nationwide prevalence of multimorbidity and estimate mortality for the most prevalent combinations of one to five diagnosis groups. Furthermore, to assess the excess mortality of the combination of two groups compared to the product of mortality associated with the single groups. DESIGN: A prospective cohort study using Danish registries and including 3.986.209 people aged ≥18 years on 1 January, 2000. Multimorbidity was defined as having diagnoses from at least 2 of 10 diagnosis groups: lung, musculoskeletal, endocrine, mental, cancer, neurological, gastrointestinal, cardiovascular, kidney, and sensory organs. Logistic regression (odds ratios, ORs) and ratio of ORs (ROR) were used to study mortality and excess mortality. RESULTS: Prevalence of multimorbidity was 7.1% in the Danish population. The most prevalent combination was the musculoskeletal-cardiovascular (0.4%), which had double the mortality (OR, 2.03) compared to persons not belonging to any of the diagnosis groups but showed no excess mortality (ROR, 0.97). The neurological-cancer combination had the highest mortality (OR, 6.35), was less prevalent (0.07%), and had no excess mortality (ROR, 0.94). Cardiovascular-lung was moderately prevalent (0.2%), had high mortality (OR, 5.75), and had excess mortality (ROR, 1.18). Endocrine-kidney had high excess mortality (ROR, 1.81) and cancer-mental had low excess mortality (ROR, 0.66). Mortality increased with the number of groups. CONCLUSIONS: All combinations had increased mortality risk with some of them having up to a six-fold increased risk. Mortality increased with the number of diagnosis groups. Most combinations did not increase mortality above that expected, that is, were additive rather than synergistic.

Interpretation of HbA1c in primary care and potential influence of anaemia and chronic kidney disease: an analysis from the Copenhagen Primary Care Laboratory (CopLab) Database.

AIMS: To investigate, in a large population in primary care, the relationship between fasting plasma glucose and HbA1c measurements, as well as the clinical implications of anaemia or chronic kidney disease for the interpretation of HbA1c values. METHODS: From a primary care resource, we examined HbA1c and fasting plasma glucose as well as haemoglobin and estimated GFR. We stratified observations by chronic kidney disease stage and anaemia level. The estimation of the mean fasting plasma glucose level from HbA1c alone, and from HbA1c , haemoglobin and estimated GFR, respectively, was evaluated. RESULTS: In 198 346 individuals, the fasting plasma glucose-HbA1c relationship mimicked the regression described in the A1c-Derived Average Glucose (ADAG) study, which was based on average capillary and interstitial glucose. The fasting plasma glucose-HbA1c relationship was unaffected in mild to moderate chronic kidney disease and in mild to moderate anaemia. The correlation changed only in severe hyperglycaemia and concurrent severe anaemia or when estimated GFR was <45 ml/min/1.73m², so that glucose concentration was underestimated by HbA1c in anaemia and overestimated in chronic kidney disease. The prevalence of estimated GFR <30 ml/min/1.73m² was 0.82%, while the prevalence of haemoglobin <81 g/l (5.0 mmol/l) was 0.11%. CONCLUSIONS: The relationship between fasting plasma glucose and HbA1c mimics that of the people with diabetes included in the ADAG study. Mild to moderate anaemia and CKD do not have a significant impact on the interpretation of HbA1c as a marker of retrograde glycaemia. Hence, it seems justified to use HbA1c without adjustment in primary care.

Helicopter vs. ground transportation of patients bound for primary percutaneous coronary intervention.

BACKGROUND: Implementation of the first Danish helicopter emergency medical service (HEMS) was associated with reduced time from first medical contact to treatment at a specialized centre for patients with suspected ST elevation myocardial infarction (STEMI). We aimed to investigate effects of HEMS on mortality and labour market affiliation in patients admitted for primary percutaneous coronary intervention (PCI). METHODS: In this prospective observational study, we included patients with suspected STEMI within the region covered by the HEMS from January 1, 2010, to April 30, 2013, transported by either HEMS or ground emergency medical services (GEMS) to the regional PCI centre. The primary outcome was 30-day mortality. RESULTS: Among the 384 HEMS and 1220 GEMS patients, time from diagnostic ECG to PCI centre arrival was lower with HEMS (median 71 min vs. 78 min with GEMS; P = 0.004). Thirty-day mortality was 5.0% and 6.2%, respectively (adjusted OR = 0.82, 95% CI 0.44-1.51, P = 0.52. Involuntary early retirement rates were 0.62 (HEMS) and 0.94 (GEMS) per 100 PYR (adjusted IRR = 0.68, 0.15-3.23, P = 0.63). The proportion of patients on social transfer payments longer than half of the follow-up time was 22.1% (HEMS) vs. 21.2% (adjusted OR = 1.10, 0.64-1.90, P = 0.73). CONCLUSION: In an observational study of patients with suspected STEMI in eastern Denmark, no significant beneficial effect of helicopter transport could be detected on mortality, premature labour market exit or work ability. Only a study with random allocation to one system vs. another, along with a large sample size, will allow determination of superiority of helicopter transport.

Effects of Diagnostic Work-Up on Medical Decision-Making for Canine Urinary Tract Infection: An Observational Study in Danish Small Animal Practices.

BACKGROUND: Clinical signs of urinary tract disease in dogs often lead to prescription of antibiotics. Appropriate diagnostic work-up could optimize treatment and reduce the risk of inappropriate use of antibiotics. HYPOTHESIS/OBJECTIVES: To describe and evaluate the impact of diagnostic work-up on decision to treat (DTT) and choice of antibiotic treatment (COT) for dogs presenting with clinical signs of urinary tract disease. ANIMALS: One hundred and fifty-one dogs presenting to 52 Danish veterinary practices. METHODS: Prospective, observational study. Clinical signs, diagnostic work-up, and prescriptions were recorded. Urine samples were submitted to a reference laboratory for quantitative bacterial culture (QBC) and susceptibility testing. The laboratory results were used as reference for assessing the appropriateness of DTT and COT. RESULTS: In the majority of dogs, veterinarians performed dipstick (99%), microscopic examination of urine (80%) and bacterial culture (56%). Fifty-one percent of dogs had urinary tract infection (UTI) based on reference QBC. Appropriate DTT was made for 62% of the dogs, while 36% were over-prescribed and 2% under-prescribed. Inappropriate use of second-line agents was found in 57% of the UTI cases. Performing microscopy-but not culture-significantly impacted DTT (P = 0.039) while no difference was seen in COT (P = 0.67). The accuracy of in-house microscopy and culture were 64.5 and 77%, respectively. CONCLUSIONS AND CLINICAL IMPORTANCE: Over-prescription of antibiotics was common among dogs with suspected UTI, regardless of the diagnostic work-up performed. Test inaccuracy under practice conditions and incoherence between diagnostic test results and decision-making both explained inappropriate and unnecessary use of antibiotics.

Decreasing incidence of foot ulcer among patients with type 1 and type 2 diabetes in the period 2001-2014.

AIM: Diabetic foot ulcer (DFU) is a serious complication to diabetes. The aim was to study the incidence of first DFU among patients with type 1 (T1DM) and type 2 diabetes (T2DM), stratified according to etiology: neuropathic, neuro-ischemic or ischemic, over a period of 14years (2001-2014). METHODS: DFU incidence rates were calculated from electronic patient record data from patients with T1DM and complicated T2DM from a large specialized diabetes hospital with a multidisciplinary foot clinic in Denmark. Poisson regression was used to model incidence of first DFU according to calendar year, diabetes type and etiology. RESULTS: Among 5640 patients with T1DM 255 developed a DFU, corresponding to an incidence of 5.8 (95% confidence interval (95%CI) 5.1-6.5) per 1000 patient years; this incidence dropped from 8.1 (95%CI 5.4-11.9) per 1000 patient years in 2002 to 2.6 (95%CI 1.3-5.3) in 2014 (p=0.0059). Among 6953 patients with T2DM 310 developed a DFU, corresponding to an incidence of 11.3 (95%CI 10.1-12.6) per 1000 patient years; this incidence dropped from 17.0 (95%CI 12.2-23.8) per 1000 patient years in 2002 to 8.7 (95%CI 5.3-14.1) per 1000 patient year (p=0.0260) in 2014. CONCLUSION: The incidence of DFU has decreased substantially in T1DM as well as in T2DM. This change was driven by a decrease in incidence of neuropathic ulcers.

Health-related quality of life in patients with chronic rheumatic disease after a multidisciplinary rehabilitation regimen.

INTRODUCTION: Multidisciplinary rehabilitation has beneficial effects on health-related quality of life (HRQoL) in patients with chronic rheumatic diseases. However, whether this intervention benefits different age groups in women or men is largely unknown. PURPOSE: To investigate HRQoL in patients with chronic rheumatic disease after completion of a 3-week multidisciplinary treatment, with special focus on differences in effect between age and gender groups. METHOD: HRQoL was measured with SF-36. Mean scores for all SF-36 domains were compared before and after the 3-week regimen and again at 3-, 6-, and 12-month follow-ups. Multivariable linear regression models using generalized estimating equations to account for repeated measurement were employed. A weighting procedure to account for differential dropouts was applied. RESULTS: Three hundred fifty-six women and 74 men with chronic rheumatic disease were included. There were short-term improvements in all SF-36 domains irrespective of age or gender. These effects persisted for up to 1 year in the psychological, social, and energy domains for women under 50. We found no lasting effects for men; however, young men showed similar trends. CONCLUSION: Inpatient multidisciplinary rehabilitation improves short-term HRQoL in all patients. Younger women maintain these beneficial effects for up to 1 year. Additional intervention should be considered for elderly women and for men in order to sustain rehabilitation effects.

Minor amputation does not negatively affect health-related quality of life as compared with conservative treatment in patients with a diabetic foot ulcer: An observational study.

BACKGROUND: Health-related quality of life (HRQoL) is poor in patients with persistent diabetic foot ulcers and poor HRQoL predicts worse outcomes in these patients. Amputation is often considered a treatment failure, which is why conservative treatment is generally preferred over amputation. However, it is unclear whether minor amputation negatively affects HRQoL compared with conservative treatment in patients with diabetic foot ulcers. METHODS: In the cohort of the multicenter, prospective, observational Eurodiale study, we determined difference in change of HRQoL measured by EQ-5D between patients with a diabetic foot ulcers that healed after conservative treatment (n = 676) and after minor amputation (n = 145). Propensity score was used to adjust for known confounders, attempting to overcome lack of randomization. RESULTS: Baseline HRQoL was not significantly different between patients treated conservatively and undergoing minor amputation. In addition, there was no difference in the change of HRQoL between these groups. In patients who healed 6 to 12 months after the first visit, HRQoL on the anxiety/depression subscale even appeared to improve more in those who underwent minor amputation. CONCLUSIONS: Minor amputation was not associated with a negative impact on HRQoL in patients with a diabetic foot ulcers. It may therefore not be considered treatment failure in terms of HRQoL but rather a viable treatment option. A randomized controlled trial is warranted to further examine the influence of minor amputations on health-related quality of life.

In hip osteoarthritis, Nordic Walking is superior to strength training and home-based exercise for improving function.

This observer-blinded, randomized controlled trial compared the short- and long-term effects of 4 months of supervised strength training (ST) in a local fitness center, supervised Nordic Walking (NW) in a local park, and unsupervised home-based exercise (HBE, control) on functional performance in 60+-year-old persons (n = 152) with hip osteoarthritis (OA) not awaiting hip replacement. Functional performance [i.e., 30-s chair stand test (primary outcome), timed stair climbing, and 6-min walk test] and self-reported outcomes (i.e., physical function, pain, physical activity level, self-efficacy, and health-related quality of life) were measured at baseline and at 2, 4, and 12 months. Based on intention-to-treat-analyses improvements [mean (95% CI)] after intervention in number of chair stands were equal in all three groups at 4 months [ST: 0.9 (0.2-1.6), NW: 1.9 (0.8-3.0), HBE: 1.1 (0.1-2.0)] but greater in the NW group [1.4 (0.02-2.8)] than in the ST group at 12 months. Generally, improvements in functional performance were greater (P < 0.001-P < 0.03) after NW compared with HBE and ST at all follow-up time points. Furthermore, NW was superior (P < 0.01) to HBE for improving vigorous physical activity and to both ST and HBE for improving (P < 0.01) mental health. These data suggest that NW is the recommended exercise modality compared with ST and HBE.

Quality of life following trauma before and after implementation of a physician-staffed helicopter.

BACKGROUND: Implementation of a physician-staffed helicopter emergency medical service (PS-HEMS) in Denmark was associated with lower 30-day mortality in severely injured trauma patients and less time on social subsidy. However, the reduced 30-day mortality in severely injured patients might be at the expense of a worse functional outcome and quality of life (QoL) in those who survive. The aim of this study was to investigate the effect of a physician-staffed helicopter on long-term QoL in trauma patients. METHODS: Prospective, observational study including trauma patients who survived at least 3 years after injury. A 5-month period prior to PS-HEMS implementation was compared with the first 12 months after PS-HEMS implementation. QoL was assessed 4.5 years after trauma by the SF-36 questionnaire. Primary endpoint was the Physical Component Summary score. RESULTS: Of the 1994 patients assessed by a trauma team, 1521 were eligible for inclusion in the study. Of these, 566 (37%) gave consent to participate and received a questionnaire by mail, and 402 (71%) of them returned the questionnaire (n = 114 before PS-HEMS; n = 288 after PS-HEMS implementation). Older patients, women and patients with trauma in the after PS-HEMS period were more likely to return the questionnaire. No significant association between QoL and period (before vs. after PS-HEMS) was found; the Physical Component Summary scores were 50.0 and 50.9 in the before and after PS-HEMS periods, respectively (P = 0.47). We also found no difference on multivariable analysis with adjustment for sex, age and injury severity score. CONCLUSION: No significant difference in QoL among trauma patients was found after implementation of a PS-HEMS.

Prevalence and clinical significance of neutropenia discovered in routine complete blood cell counts: a longitudinal study.

BACKGROUND: Neutropenia, defined as an absolute blood neutrophil count (ANC) <1.5 G L(-1) , may accompany a variety of diseases. However, the clinical significance of neutropenia detected in a routine complete blood cell count is poorly understood. METHODS: Using a primary care resource, comprising more than 370 000 individuals, we assessed the association with a number of previously recognized conditions as well as all-cause mortality in the 4 years following the identification of neutropenia. By matching laboratory data with Danish nationwide health registers, risk estimates were assessed. RESULTS: Neutropenia was observed in approximately 1% of all individuals and was associated dose dependently with viral infections, haematological malignancies (but not autoimmune disorders or solid cancers) and mortality. Neutropenia was particularly associated with HIV, acute leukaemias and myelodysplastic syndromes. Odds ratios [95% confidence interval (CI)] for viral infections were 2.32 (1.84-2.91), 2.80 (2.20-3.57) and 4.77 (3.22-7.07) for subnormal (≥1.5-1.8 G L(-1) ), mild (≥1.0-1.5 G L(-1) ) and moderate-severe (≥0.0-1.0 G L(-1) ) neutropenic individuals, respectively (all P < 0.001). Likewise, odds ratios (95% CI) for haematological malignancies were 3.23 (2.35-4.45), 8.69 (6.58-11.47) and 46.03 (33.98-62.35 ), for the same neutropenia levels, respectively (all P < 0.001). Thus, the lower the ANC, the greater the likelihood of these diseases. The relative risk estimates observed for severe neutropenia corresponded to absolute risks of haematological malignancies and mortality from any cause of 40% and >50%, respectively. CONCLUSIONS: Neutropenia is an ominous sign necessitating careful follow-up. The risk estimates presented here support focusing attention to viral diseases and haematological malignancies when neutropenia is observed.

The role of the anterolateral ligament in ACL insufficient and reconstructed knees on rotatory stability: A biomechanical study on human cadavers.

Studies suggest that the anterolateral ligament (ALL) is important for knee stability. The purpose was to clarify ALL's effect on rotatory and anterior-posterior stability in the anterior cruciate ligament (ACL)-insufficient and reconstructed knees and the effect of reconstruction of an insufficient ALL. Eighteen cadaveric knees were included. Stability was tested for intact (+ALL), detached (-ALL) and reconstructed (+ reALL) ALL, with ACL removed (-ACL) and reconstructed (+ACL) in six combinations. All were tested in 0, 30, 60, and 90 °C flexion. Anterior-posterior stability was measured with a rolimeter. Rotation with a torque of 8.85 Nm was measured photographically. The ALL was well defined in 78% of knees. ACL reconstruction had a significant effect on anterior-posterior stability. Detaching the ALL had a significant effect on internal rotatory stability and on anterior-posterior stability in ACL-insufficient knees. Reconstruction of ACL and ALL reestablished knee stability. The appearance of the ALL was not uniform. The ALL was an internal rotational stabilizer. Anatomical ALL reconstruction in combination with ACL reconstruction could reestablish stability. ALL reconstruction might be considered in patients with combined ACL and ALL tears, but the clinical effect should be established in a controlled clinical study.

Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95.

BACKGROUND: Theoretically, the ideal volume of local anaesthetic for adductor canal block (ACB) would ensure sufficient filling of the canal and avoid proximal spread to the femoral triangle. In this dose-finding study, we aimed to investigate the minimal effective volume for an ACB needed to fill the adductor canal distally in at least 95% of patients (ED95). METHODS: We performed a blinded trial, enrolling 40 healthy men. All subjects received an ACB with lidocaine 1%. Volumes were assigned sequentially to the subjects using the continual reassessment method followed by Bayesian analysis to determine the ED95. Distal filling of the adductor canal was assessed by magnetic resonance imaging (primary outcome). Secondary outcomes were the effect of volume on proximal spread to the femoral triangle (also assessed by magnetic resonance imaging), quadriceps muscle weakness (decrease by ≥25% from baseline) and sensory block. RESULTS: The ED95 was 20 ml, with an estimated probability of sufficiently filling the canal of 95.1% (95% credibility interval: 0.91-0.98). Proximal spread to the femoral triangle was seen in 0/4 (0%), 7/12 (58%), 4/8 (50%), and 8/16 (50%) subjects with the 5, 10, 15, and 20 ml doses, respectively (P=0.25). Seven subjects had a reduction in muscle strength, but there was no difference between groups (P=0.85). CONCLUSIONS: For an ACB, the dose closest to the ED95 needed to fill the adductor canal distally was 20 ml. There was no significant correlation between volume and proximal spread or muscle strength. CLINICAL TRIAL REGISTRATION: NCT02033356.

Increased healing in diabetic toe ulcers in a multidisciplinary foot clinic-An observational cohort study.

AIM: To study toe ulcer healing in patients with diabetic foot ulcers attending a multidisciplinary foot clinic over a 10 years period. METHODS: The study was retrospective, consecutive and observational during 2001 through 2011. The patients were treated according to the International Consensus on the Diabetic Foot. During the period the chiropodist staffing in the foot clinic was doubled; new offloading material and orthopedic foot corrections for recalcitrant ulcers were introduced. Healing was investigated in toe ulcers in Cox regression models. RESULTS: 2634 patients developed foot ulcers, of which 1461 developed toe ulcers; in 790 patients these were neuropathic, in 551 they were neuro-ischemic and in 120 they were critically ischemic. One-year healing rates increased in the period 2001-2011 from 75% to 91% for neuropathic toe ulcers and from 72% to 80% for neuro-ischemic toe ulcers, while no changes was observed for ischemic toe ulcers. Adjusted for changes in the patient population, the overall rate of healing for neuropathic and neuro-ischemic toe ulcers almost doubled (HR=1.95 [95% CI: 1.36-2.80]). CONCLUSION: The results show that the healing of toe ulcers improved. This outcome could not be explained by changes in the patient characteristics, but coincided with a number of improvements in organization and therapy.

Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST).

OBJECTIVES: To measure the psychosocial consequences in the Danish lung cancer screening trial (DLCST) and compare those between the computed tomography (CT) group and the control group. MATERIALS AND METHODS: This study was a single centre randomised controlled trial with five annual screening rounds. Healthy current or former heavy smokers aged 50-70 years (men and women) were randomised 1:1 to a CT group and a control group. Heavy smokers were defined by having smoked ≥20 pack years and former smokers by being abstinent ≤10 years. Both groups were invited annually to the screening clinic to complete the validated lung-cancer-specific questionnaire consequences of screening lung cancer (COS-LC). The CT group was also offered a low dose CT scan of the lungs. The COS-LC measures nine scales with psychosocial properties: Anxiety, Behaviour, Dejection, Negative impact on sleep, Self-blame, Focus on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking. RESULTS: 4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from baseline through rounds 2-5 for both the CT group and the control group (mean increase >0, p<.0001 for 3 of 4 possible scales). During rounds 2-5 the control group experienced significantly more negative psychosocial consequences in seven of nine scales compared with the CT group (mean Δ score >0 and p<.033). CONCLUSIONS: Lung cancer CT-screening trials induced more negative psychosocial reactions in both the CT group and the control group compared with the baseline psychosocial profile. The CT group experienced less negative psychosocial consequences compared with the control group, which might be explained by reassurance among those with normal screening results. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00496977.

Motivation, effort and life circumstances as predictors of foot ulcers and amputations in people with Type 2 diabetes mellitus.

AIM: To investigate the predictive value of both patients' motivation and effort in their management of Type 2 diabetes and their life circumstances for the development of foot ulcers and amputations. METHODS: This study was based on the Diabetes Care in General Practice study and Danish population and health registers. The associations between patient motivation, effort and life circumstances and foot ulcer prevalence 6 years after diabetes diagnosis and the incidence of amputation in the following 13 years were analysed using odds ratios from logistic regression and hazard ratios from Cox regression models, respectively. RESULTS: Foot ulcer prevalence 6 years after diabetes diagnosis was 2.93% (95% CI 1.86-4.00) among 956 patients. General practitioners' indication of 'poor' vs 'very good' patient motivation for diabetes management was associated with higher foot ulcer prevalence (odds ratio 6.11, 95% CI 1.22-30.61). The same trend was seen for 'poor' vs 'good' influence of the patient's own effort in diabetes treatment (odds ratio 7.06, 95% CI 2.65-18.84). Of 1058 patients examined at 6-year follow-up, 45 experienced amputation during the following 13 years. 'Poor' vs 'good' influence of the patients' own effort was associated with amputation (hazard ratio 7.12, 95% CI 3.40-14.92). When general practitioners assessed the influence of patients' life circumstances as 'poor' vs 'good', the amputation incidence increased (hazard ratio 2.97, 95% CI 1.22-7.24). 'Poor' vs 'very good' patient motivation was also associated with a higher amputation incidence (hazard ratio 7.57, 95% CI 2.43-23.57), although not in fully adjusted models. CONCLUSIONS: General practitioners' existing knowledge of patients' life circumstances, motivation and effort in diabetes management should be included in treatment strategies to prevent foot complications.

Risk of new or recurrent cancer after a high perioperative inspiratory oxygen fraction during abdominal surgery.

BACKGROUND: Administration of supplemental oxygen in the perioperative period is controversial, as it may increase long-term mortality. Our aim was to assess the association between 80% oxygen and occurrence of subsequent cancer in patients undergoing abdominal surgery in a post hoc analysis of the PROXI trial. METHODS: The 1386 patients in the PROXI trial underwent elective or emergency laparotomy between 2006 and 2008 with randomization to either 80% or 30% oxygen during and for 2 h after surgery. We retrieved follow-up status regarding vital status, new cancer diagnoses, and new histological cancer specimens. Data were analysed using the Cox proportional hazards model. RESULTS: Follow-up was complete in 1377 patients (99%) after a median of 3.9 yr. The primary outcome of new cancer diagnosis or new malignant histological specimen occurred in 140 of 678 patients (21%) in the 80% oxygen group vs 150 of 699 patients (21%) assigned to 30% oxygen; hazards ratio 1.06 [95% confidence interval (CI) 0.84, 1.34], P=0.62. Cancer-free survival was significantly shorter in the 80% oxygen group; hazards ratio 1.19 (95% CI 1.01, 1.42), P=0.04, as was the time between surgery and new cancer, median 335 vs. 434 days in the 30% oxygen group. In patients with localized disease, non-significant differences in cancer and cancer-free survival were found with hazard ratios of 1.31 and 1.29, respectively. CONCLUSIONS: Although new cancers occurred at similar rate, the cancer-free survival was significantly shorter in the 80% oxygen group, but this did not appear to explain the excess mortality in the 80% oxygen group. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01723280).

A three-year follow-up on the efficacy of psychosocial interventions for patients with mild dementia and their caregivers: the multicentre, rater-blinded, randomised Danish Alzheimer Intervention Study (DAISY).

OBJECTIVES: To examine the long-term efficacy at the 36-month follow-up of an early psychosocial counselling and support programme lasting 8-12 months for community-dwelling patients with mild Alzheimer's disease and their caregivers. DESIGN: Multicentre, randomised, controlled, rater-blinded trial. SETTING: Primary care and memory clinics in five Danish districts. PARTICIPANTS: 330 home-dwelling patients with mild Alzheimer's disease and their primary caregivers (dyads). INTERVENTIONS: Dyads were randomised to receive intervention during the first year after diagnosis. Both intervention and control groups had follow-up visits at 3, 6, 12 and 36 months. MAIN OUTCOME MEASURES: Primary outcomes for the patients assessed at 36-month follow-up were changes from baseline in global cognitive function (Mini-Mental State Examination), depressive symptoms (Cornell Depression Scale) and proxy-rated EuroQoL quality of life on visual analogue scale. The primary outcomes for the caregivers were changes from baseline in depressive symptoms (Geriatric Depression Scale) and self-rated EuroQoL quality of life on a visual analogue scale. The secondary outcome measures for the patient were proxy-rated Quality of Life Scale for Alzheimer's disease (QoL-AD), Neuropsychiatric Inventory-Questionnaire, Alzheimer's disease Cooperative Study Activities of Daily Living Scale, all-cause mortality and nursing home placement. RESULTS: At a 36-month follow-up, 2 years after the completion of the Danish Alzheimer Intervention Study (DAISY), the unadjusted positive effects previously detected at the 12-month follow-up in one patient primary outcome (Cornell depression score) and one patient secondary outcome (proxy-rated QoL-AD) disappeared (Cornell depression score, p=0.93; proxy-rated QoL-AD, p=0.81). No long-term effect of DAISY intervention on any other primary and secondary outcomes was found at the 36-month follow-up. CONCLUSIONS: For patients with very mild Alzheimer's disease and their caregivers, an intensive, multi-component, semitailored psychosocial intervention programme with counselling, education and support during the first year after diagnosis did not show any positive long-term effect on primary and secondary outcomes. TRIAL REGISTRATION: The study was registered in the Clinical Trial Database (http://www.controlled-trials.com/ISRCTN74848736).

Importance of factors determining the low health-related quality of life in people presenting with a diabetic foot ulcer: the Eurodiale study.

AIM: To identify the factors responsible for the low health-related quality of life associated with foot ulcers and the relative importance of these factors. METHODS: A total of 1232 patients with a new foot ulcer, who presented at one of the 14 centres in 10 European countries participating in the Eurodiale study, were included in this cross-sectional study. Patient and ulcer characteristics were obtained as well as results from the Euro-Qol-5D questionnaire, a health-related quality of life instrument with five domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). To analyse the relative importance of comorbidities and ulcer- and patient-related factors for health-related quality of life, linear regression models were used to calculate the relative contributions of each factor to the fit (R(2) ) of the model. RESULTS: Patients reported poor overall health-related quality of life, with problems primarily in the mobility and pain/discomfort domains. Among the comorbidities, the inability to stand or walk without help was the most important determinant of decreased health-related quality of life in all five domains. Among ulcer-related factors, ulcer size, limb-threatening ischaemia and elevated C-reactive protein concentration also had high importance in all domains. The clinical diagnosis of infection, peripheral arterial disease and polyneuropathy were only important in the pain/discomfort domain. CONCLUSIONS: The factors that determine health-related quality of life are diverse and to an extent not disease-specific. To improve health-related quality of life, treatment should not only be focused on ulcer healing but a multifactorial approach by a specialized multidisciplinary team is also important.