Swedish Centres Research Articles

Diagnostic methods for acute otitis media in 1 to 12\u2009year old children: a cross sectional study in primary health care

BackgroundOtoscopy alone has low sensitivity and specificity for acute otitis media (AOM). Otomicroscopy and pneumatic methods are superior to otoscopy. However, these methods require clinical skills. The use of different diagnostic methods for AOM differs between countries and has not been evaluated in Sweden since new guidelines were introduced in 2010. This study aimed to describe the extent of which diagnostic methods and written advice were used for AOM in children 1 to 12 years old.MethodsIn this cross-sectional study all general practitioners (GPs) and specialist trainees in primary care (STs) at 27 primary health care centres in Sweden were asked to complete a self-administrated questionnaire including diagnostic approach and the management of AOM; 75% (111/148) responded to the questionnaire. Outcome Measures: GPs versus STs and their gender, the use of otoscopy, pneumatic otoscopy, otomicroscopy, tympanometry and written advice. Logistic regressions were used to evaluate the association between GPs versus STs and their gender and the use of diagnostic methods and written advice.ResultsTo diagnose AOM, 98% of the GPs and STs often or always used otoscopy, in addition to this 17% often or always used otomicroscopy, 18% pneumatic otoscopy and 11% tympanometry. Written advice to parents was provided often or always by 19% of the GPs and STs.The GPs used otomicroscopy more often than STs, adjusted OR 4.9 (95% CI 1.5–17; p = 0.011). For the other diagnostic methods, no differences were found. Female GPs and STs provided written advice more often than male GPs and STs, OR 5.2 (95% CI, 1.6–17; p = 0.0061), adjusted for GP versus ST.ConclusionsOtoscopy was by far the most commonly used method for the diagnosis of AOM. Female GPs and STs provided written advice more frequently than did their male colleagues. GPs used the significantly better method otomicroscopy more often than STs, therefore, it is important to emphasise teaching of practical skills in otomicroscopy in the specialist training programme for general practice. A correct diagnosis is important for avoiding potentially harmful antibiotic treatments, antimicrobial resistance and possible delay of other diagnoses.

Clinical validation of the Swedish version of Dyspnoea-12 instrument in outpatients with cardiorespiratory disease

IntroductionBreathlessness is the cardinal symptom in both cardiac and respiratory diseases, and includes multiple dimensions. The multidimensional instrument Dyspnoea-12 has been developed to assess both physical and affective components of...

Validation of the Norwegian survival prediction model in trauma (NORMIT) in Swedish trauma populations.

Trauma survival prediction models can be used for quality assessment in trauma populations. The Norwegian survival prediction model in trauma (NORMIT) has been updated recently and validated internally (NORMIT 2). The aim of this observational study was to compare the accuracy of NORMIT 1 and 2 in two Swedish trauma populations. Adult patients registered in the national trauma registry during 2014-2016 were eligible for inclusion. The study populations comprised the total national trauma (NT) population, and a subpopulation of patients admitted to a single level I trauma centre (TC). The primary outcome was 30-day mortality. Model validation included receiver operating characteristic (ROC) curve analysis and GiViTI calibration belts. The calibration was also assessed in subgroups of severely injured patients (New Injury Severity Score (NISS) over 15). A total of 26 504 patients were included. Some 18·7 per cent of patients in the NT population and 2·6 per cent in the TC subpopulation were excluded owing to missing data, leaving 21 554 and 3972 respectively for analysis. NORMIT 1 and 2 showed excellent ability to distinguish between survivors and non-survivors in both populations, but poor agreement between predicted and observed outcome in the NT population with overestimation of survival, including in the subgroup with NISS over 15. In the TC subpopulation, NORMIT 1 underestimated survival irrespective of injury severity, but NORMIT 2 showed good calibration both in the total subpopulation and the subgroup with NISS over 15. NORMIT 2 is well suited to predict survival in a Swedish trauma centre population, irrespective of injury severity. Both NORMIT 1 and 2 performed poorly in a more heterogeneous national population of injured patients.

A grading scale for surgically treated patients with spontaneous supratentorial intracerebral hemorrhage: the Surgical Swedish ICH Score.

The authors aimed to develop the first clinical grading scale for patients with surgically treated spontaneous supratentorial intracerebral hemorrhage (ICH). A nationwide multicenter study including 401 ICH patients surgically treated by craniotomy and evacuation of a spontaneous supratentorial ICH was conducted between January 1, 2011, and December 31, 2015. All neurosurgical centers in Sweden were included. All medical records and neuroimaging studies were retrospectively reviewed. Independent predictors of 30-day mortality were identified by logistic regression. A risk stratification scale (the Surgical Swedish ICH [SwICH] Score) was developed using weighting of independent predictors based on strength of association. Factors independently associated with 30-day mortality were Glasgow Coma Scale (GCS) score (p = 0.00015), ICH volume ≥ 50 mL (p = 0.031), patient age ≥ 75 years (p = 0.0056), prior myocardial infarction (MI) (p = 0.00081), and type 2 diabetes (p = 0.0093). The Surgical SwICH Score was the sum of individual points assigned as follows: GCS score 15-13 (0 points), 12-5 (1 point), 4-3 (2 points); age ≥ 75 years (1 point); ICH volume ≥ 50 mL (1 point); type 2 diabetes (1 point); prior MI (1 point). Each increase in the Surgical SwICH Score was associated with a progressively increased 30-day mortality (p = 0.0002). No patient with a Surgical SwICH Score of 0 died, whereas the 30-day mortality rates for patients with Surgical SwICH Scores of 1, 2, 3, and 4 were 5%, 12%, 31%, and 58%, respectively. The Surgical SwICH Score is a predictor of 30-day mortality in patients treated surgically for spontaneous supratentorial ICH. External validation is needed to assess the predictive value as well as the generalizability of the Surgical SwICH Score.

Atrial fibrillation incidence and impact of biventricular pacing on long-term outcome in patients with heart failure treated with cardiac resynchronization therapy

BackgroundIn patients with cardiac resynchronization therapy (CRT), atrial fibrillation (AF) is associated with an unfavorable outcome and may cause loss of biventricular pacing (BivP). An effective delivery of BivP of more than 98% of all ventricular beats has been shown to be a major determinant of CRT-success.MethodsAt a Swedish tertiary referral center, data was retrospectively obtained from patient registers, medical records and preoperative electrocardiograms. Data regarding AF and BivP during the first year of follow-up was assessed from CRT-device interrogations. No intra-cardiac electrograms were studied. Kaplan-Meier curves and Cox-regression analyses adjusted for age, etiology of heart failure, left ventricular ejection fraction, left bundle branch block and NYHA class were performed to assess the impact of AF and BivP on the risk of death or heart transplantation (HTx) at 10-years of follow-up.ResultsPreoperative AF-history was found in 54% of the 379 included patients and was associated with, but did not independently predict death or HTx. The one-year incidence of new device-detected AF was 22% but not associated with poorer prognosis. At one-year, AF-history and BivP≤98%, was associated with a higher risk of death or HTx compared to patients without AF (HR 1.9, 95%CI 1.2–3.0, p = 0.005) whereas AF and BivP> 98% was not (HR 1.4, 95%CI 0.9–2.3, p = 0.14).ConclusionsIn CRT-recipients, AF-history is common and associated with poor outcome. AF-history does not independently predict mortality and is probably only a marker of a more severe underlying disease. BivP≤98% during first-year of CRT-treatment independently predicts poor outcome thus further supporting the use of 98% threshold of BivP, which should be attained to maximize the benefits of CRT.

Drug information centre queries and responses about drug interactions over 10years-A descriptive analysis.

Many people are treated with ≥1 drug, implying that risks of drug interactions need to be considered. The aim of this study was to describe drug interaction queries from healthcare professionals to a drug information centre in Sweden over 10 years focusing on drugs frequently asked about and the advice provided. Advice was recorded in mutually exclusive groups: Avoid, Adjust dose, Separate intake, Vigilance or No problem. For queries with Avoid, Adjust dose or Separate intake advice, alerts were extracted from an interaction database (Janusmed). Of 4335 queries to the centre in 2008‐2017, 589 (14%) concerned interactions. Most were posed by physicians (91%) and concerned a specific patient (83%) before treatment initiation (76%). Sertraline, warfarin and methotrexate were the most frequently asked about, whereas queries about cyclophosphamide and rifampicine occurred most often in relation to the number of exposed patients. Advice provided in 557 (95%) replies comprised Avoid: n = 85 (15%), Adjust dose: n = 57 (10%), Separate intake: n = 17 (3%), Vigilance: n = 235 (42%) or No problem: n = 163 (29%). In all, 113 (71%) of 159 queries with Avoid/Adjust dose/Separate intake advice elicited an action alert on Janusmed, whereas 31 (20%) did not result in any alert at all. Summarized, seven in ten replies from the drug information centre recommended an explicit drug treatment action, regarding either specific prescribing aspects, for instance dose adjustments, or active follow‐up including monitoring potential adverse reactions and/or laboratory results. Readily accessible decision support regarding drug interactions often provides relevant action alerts, but cannot be solely relied on.

PCASTt/SPCG-17—a randomised trial of active surveillance in prostate cancer: rationale and design

IntroductionOvertreatment of localised prostate cancer is substantial despite increased use of active surveillance. No randomised trials help define how to monitor patients or when to initiate treatment with curative intent.Methods...

Management strategies and treatment results of pediatric choledochal malformations in the Nordic countries

BackgroundIncidence and long-term outcomes of choledochal malformations (CMs) in children remain unclear. MethodsClinical characteristics, operative details, complications, and follow-up data were collected from eight pediatric surgical centers in Sweden, Norway, Denmark, and Finland, which also answered a questionnaire addressing management practices. ResultsDuring 2000–2017, 126 pediatric CMs were diagnosed, corresponding an incidence of 1:37,400. Diagnostic, treatment, and follow-up practices varied markedly. Of patients with complete clinical data (n = 119), 85% and 11% had type I and IV CMs and were managed by open hepaticojejunostomy at median age of 2.5 (interquartile range 0.46–5.8) years. Associated malformations were more common in fusiform and type IV (23%) than cystic CMs (8%, p = 0.043). Pancreaticobiliary maljunction was more frequently confirmed in patients presenting with pancreatitis (26% vs. 7%, p = 0.005) and with fusiform CMs (56% vs. 25%, p = 0.001). Cholangitis/pancreatitis episodes, occurring in 12% during postoperative follow-up of 4.0 (2.0–7.9) years, associated with longer surveillance (OR 1.32, 95% CI 1.13–1.54, p < 0.001). However, only two thirds of centers continued follow-up until adulthood. No malignancies were reported. ConclusionsCM incidence was higher than traditionally reported among Western populations. Although open hepaticojejunostomy carries good short-term outcomes, long-term morbidity is noteworthy. Standardized evidence-based management strategies and long-term follow-up are encouraged.

Physicians working in oncology identified challenges and factors that facilitated communication with families when children could not be cured.

AimWe explored physicians’ experiences of communicating with families when their child had cancer and a cure was no longer an option, by focusing on barriers and facilitating factors.MethodsPhysicians from the six cancer centres in Sweden took part in focus group discussions between December 2017 and May 2018, and the data were analysed using qualitative content analysis. Focus groups enabled us to gather individual and shared perspectives.ResultsThe 35 physicians (20 male) had a mean age of 47 (range 31‐74) and a mean of 11 years’ experience in oncology, ranging from under one year to 43 years. They reported communication challenges when a cure was not possible, namely: emotional and mental drain, lack of mutual understanding and uncertainty about communication skills. They also reported facilitating factors: flexibility in complex conversations, the child’s position in the conversations, continuity and trusting relationships, support from colleagues and having discussed the potentially life‐threatening nature of cancer from the very start of treatment.ConclusionTraining to overcome communication issues could support the early integration of palliative care.

Elective oocyte freezing for nonmedical reasons: a 6-year report on utilization and in vitro fertilization results from a Swedish center.

Elective oocyte freezing started in Sweden in 2011, a few years after oocyte vitrification was introduced internationally as an effective method for cryopreservation of oocytes. The objective of this study is to describe the age of the women who choose to undergo this procedure, the subsequent utilization of cryopreserved oocytes and the results of autologous in vitro fertilization (IVF). We conducted a descriptive follow-up study of a subset of women at a private IVF center. All women (n=254) who electively vitrified oocytes at Nordic IVF Göteborg between 1 August 2011 and 31 August 2017 were included. Ages at oocyte vitrification and warming, number of vitrified oocytes and results of IVF are presented. A total of 254 women underwent elective oocyte freezing and 38 (15%) of these returned to use their cryopreserved oocytes for autologous IVF before November 2018. In the total cohort, the mean number of vitrified oocytes per woman, undergoing one or more oocyte retrievals, was 7.6 (range 1-37). Their mean age at first vitrification was 36.9years (range 23-43years). The mean ages for the subset of women that subsequently used their oocytes for IVF were 38.7 and 42.7years at vitrification and oocyte warming, respectively. Forty-nine oocyte warming cycles resulting in 42 fresh and 16 frozen embryo transfers, have been performed. Cumulative live birth rate/ongoing pregnancy rates are 63%, 26% and 0% in women of ages 36-37, 38-39 and ≥40years of age at vitrification, respectively. Five babies have been born and there are 5 ongoing pregnancies. Elective oocyte freezing has been offered in Sweden for >7years. The utilization rate has so far been low. Pregnancy results after oocyte warming and IVF are encouraging when oocytes are cryopreserved at an age below 40years.

Outcome After Endovascular Repair of Ruptured Descending Thoracic Aortic Aneurysm: A National Multicentre Study

The purpose of this multicentre study was to analyse the outcome of thoracic endovascular aortic repair (TEVAR) in patients with ruptured descending thoracic aortic aneurysm (rDTAA). This is a nationwide retrospective study including all patients who underwent TEVAR for rDTAA at six major vascular university centres in Sweden between January 2000 and December 2015. Outcome measures were analysed using Kaplan–Meier estimator and multivariable Cox regression. There were 140 patients (age [mean ± SD] 74.1 ± 8.8 years; 56% men; aneurysm size 64.8 ± 19 mm), with rDTAA. In 53 patients (37.9%), the left subclavian artery was covered, and in 25 patients (17.9%) arch vessel revascularisation was performed. In total, 61/136 patients (45%) had a major complication within 30 days post TEVAR. Stroke (n = 20; 14.7%) was the most common complication, followed by paraplegia (n = 13; 9.6%) and major bleeding (n = 13; 9.6%). TEVAR related complications during follow up included endoleaks 22.1% (30/136; 14 type 1a, six type 1b, 10 not defined). In total, re-interventions (n = 31) were required in 27/137 (19.7%) patients. The median follow up time was 17.0 months (range 0–132 months). The Kaplan–Meier estimated survival was 80.0% at one month, 71.7% at three months, 65.3% at one year, 45.9% at three years, and 31.9% at five years. Age (HR 1.03; 95% CI 1.00–1.07; p = .046), history of stroke (HR 2.35; 95% CI 1.19–4.63; p = .014), previous aortic surgery (HR 2.11; 95% CI 1.15–3.87; p = .016) as well as post-operative major bleeding (HR 4.40; 95% CI 2.20–8.81; p = .001), stroke (HR 2.63; 95% CI 1.37–5.03; p = .004), and renal failure (HR 8.25; 95% CI 2.69–25.35; p = .001) were all associated with mortality. This nationwide multicentre study of patients with rDTAA undergoing TEVAR showed acceptable short- but poor long-term survival. Adequate proximal and distal aortic sealing zones are important for technical success. High risk patients and post-operative complications need to be further addressed in an effort to improve outcome.

The Handling of the Rectal Stump Does Not Affect Severe Morbidity After Subtotal Colectomy For Ulcerative Colitis: A Retrospective Cohort Study

Colectomy due to ulcerative colitis is associated with complications. One severe complication is the risk for blow-out of the remaining rectal remnant. The aim of this study was to compare the frequency and severity of complications in patients with the rectal remnant left subcutaneously versus patients with the rectal remnant left intra-abdominally. A secondary aim was to identify risk factors for complications. Consecutive patients at two tertiary centers in Sweden were retrospectively reviewed regarding surgical procedures; complications classified according to Clavien-Dindo; and possible risk factors for complications such as preoperative medication, emergency surgery, and body mass index. 307 patients were identified. Minor complications were more common than previously reported (85%-89%). Severe surgical complications were not related to the handling of the rectal remnant. Leaving the rectal remnant subcutaneously was associated with local wound problems. Risk factors for severe complications were emergency surgery and preoperative medication with 5-aminosalicylic acid. Minor complications after colectomy for ulcerative colitis are very common and need to be addressed. Leaving the rectal stump intra-abdominally seems safe and may be advantageous to reduce local wound morbidity.

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial

Hypofractionated radiotherapy for prostate cancer has gained increased attention due to its proposed high radiation-fraction sensitivity. Recent reports from studies comparing moderately hypofractionated and conventionally fractionated radiotherapy support the clinical use of moderate hypofractionation. To date, there are no published randomised studies on ultra-hypofractionated radiotherapy. Here, we report the outcomes of the Scandinavian HYPO-RT-PC phase 3 trial with the aim to show non-inferiority of ultra-hypofractionation compared with conventional fractionation. In this open-label, randomised, phase 3 non-inferiority trial done in 12 centres in Sweden and Denmark, we recruited men up to 75 years of age with intermediate-to-high-risk prostate cancer and a WHO performance status between 0 and 2. Patients were randomly assigned to ultra-hypofractionation (42·7 Gy in seven fractions, 3 days per week for 2·5 weeks) or conventional fractionated radiotherapy (78·0 Gy in 39 fractions, 5 days per week for 8 weeks). No androgen deprivation therapy was allowed. The primary endpoint was time to biochemical or clinical failure, analysed in the per-protocol population. The prespecified non-inferiority margin was 4% at 5 years, corresponding to a critical hazard ratio (HR) limit of 1·338. Physician-recorded toxicity was measured according to the Radiation Therapy Oncology Group (RTOG) morbidity scale and patient-reported outcome measurements with the Prostate Cancer Symptom Scale (PCSS) questionnaire. This trial is registered with the ISRCTN registry, number ISRCTN45905321. Between July 1, 2005, and Nov 4, 2015, 1200 patients were randomly assigned to conventional fractionation (n=602) or ultra-hypofractionation (n=598), of whom 1180 (591 conventional fractionation and 589 ultra-hypofractionation) constituted the per-protocol population. 1054 (89%) participants were intermediate risk and 126 (11%) were high risk. Median follow-up time was 5·0 years (IQR 3·1-7·0). The estimated failure-free survival at 5 years was 84% (95% CI 80-87) in both treatment groups, with an adjusted HR of 1·002 (95% CI 0·758-1·325; log-rank p=0·99). There was weak evidence of an increased frequency of acute physician-reported RTOG grade 2 or worse urinary toxicity in the ultra-hypofractionation group at end of radiotherapy (158 [28%] of 569 patients vs 132 [23%] of 578 patients; p=0·057). There were no significant differences in grade 2 or worse urinary or bowel late toxicity between the two treatment groups at any point after radiotherapy, except for an increase in urinary toxicity in the ultra-hypofractionation group compared to the conventional fractionation group at 1-year follow-up (32 [6%] of 528 patients vs 13 [2%] of 529 patients; (p=0·0037). We observed no differences between groups in frequencies at 5 years of RTOG grade 2 or worse urinary toxicity (11 [5%] of 243 patients for the ultra-hypofractionation group vs 12 [5%] of 249 for the conventional fractionation group; p=1·00) and bowel toxicity (three [1%] of 244 patients vs nine [4%] of 249 patients; p=0·14). Patient-reported outcomes revealed significantly higher levels of acute urinary and bowel symptoms in the ultra-hypofractionation group compared with the conventional fractionation group but no significant increases in late symptoms were found, except for increased urinary symptoms at 1-year follow-up, consistent with the physician-evaluated toxicity. Ultra-hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy for intermediate-to-high risk prostate cancer regarding failure-free survival. Early side-effects are more pronounced with ultra-hypofractionation compared with conventional fractionation whereas late toxicity is similar in both treatment groups. The results support the use of ultra-hypofractionation for radiotherapy of prostate cancer. The Nordic Cancer Union, the Swedish Cancer Society, and the Swedish Research Council.

The Swedish Taxonomy Initative &amp;amp; Biodiversity Infrastructure

The Swedish Species Information Centre (ArtDatabanken, SSIC) at the Swedish University of Agricultural Sciences (SLU) accumulates, analyses and disseminates information concerning Swedish species, habitats and ecosystems. The SSIC hosts the Swedish Taxonomy Initiative (STI) and produces the Swedish Red List. In addition, the SSIC is the leading partner within the Swedish LifeWatch (SLW) consortium, which cooperates with the Biodiversity Atlas Sweden (BAS) and the Living Atlas Community. The SSIC provides an open access biodiversity reporting and analysis infrastructure including for example the Swedish Species Observation System (artportalen.se), the Swedish taxonomic backbone (dyntaxa.se) and tools for species information including traits, terminology and species determination (artfakta.se). All systems, including the SLW Analysis Portal (analysisportal.se), rely on recognized standards to ensure interoperability and consist of databases, API:s and portals. The Artportalen platform now contains &amp;gt;69 000 000 georeferenced observations, along with 1 300 000 images, video or sound, of some 32 000 species from Sweden. The data are harvested by SLW and the Global Biodiversity Information Facility (GBIF). In addition to reports from NGOs and the general public, which generate &amp;gt;90% of the observations, a rapidly increasing number of Swedish governmental authorities and agencies are using the platform to store regional and local species inventories collected by standardized scientific methods. There are sophisticated systems for validation and to secure data quality, and the records are used by scientists as well as by county and municipality councils as a principle biodiversity resource in environmental planning and decision making. Data concerning some species considered to be particularly sensitive to disturbance are classified and not openly available. These data can be accessed via a hierarchy of access levels so as to enable such classified data to available to, for example, environmental officers and to be used in management purposes The SSIC has just launched new API:s, modules for improved reporting of species checklists and invasive species, and a new platform aggregating the services in a single web interface and based on responsive design and specific interfaces for different users (artfakta.se). Improvements are also to be made in the infrastructure of the Swedish taxonomic backbone, which now contains data for almost all Swedish species (more than 275 000 scientific names and 62 000 species). In 2002, when the Swedish Taxonomy Initiative (STI) was established, the SSIC was commissioned by the Swedish Parliament to identify all species of multicellular plants, fungi and animals in the country and to make the information available to scientists, conservationists and the public. The information is presented in the Artfakta platform and in a series of identification handbooks, The Encyclopedia of the Swedish Flora and Fauna. In addition, the STI supports barcoding activities, scientific courses and announces grants for museums and taxonomic research and inventories within poorly known organismal groups. The Swedish and Norwegian taxonomy initiatives work cooperatively to increase the collective knowledge of poorly known species and, as a result, more than 3 000 species new to Sweden and Norway have been found, approximately a third being new to science. The attempt to join forces between different Scandinavian counterparts via technical progress and to focus on digitalization and sharing information on species and communities from the same biogeographical region has proven a successful concept.

Scandcleft Project, Trial 1: Comparison of Speech Outcome in Relation to Timing of Hard Palate Closure in 5-Year-Olds With UCLP.

To compare in-depth speech results in Scandcleft Trial 1 as well as reference data from peers without cleft palate (CP). A prospective randomized clinical trial. A Danish and a Swedish CP center. 143 of 148 randomized 5-year-olds with unilateral cleft lip and palate. All received lip and velum closure at 4 months, and hard palate closure at 12 months (arm A) or 36 months (arm B). A composite measure based on velopharyngeal competence (VPC) or velopharyngeal incompetence (VPI), an overall assessment of VPC from connected speech (VPC-Rate), Percentage of Consonants Correct (PCC-score), and consonant errors. Speech therapy visits, average hearing thresholds, and secondary pharyngeal surgeries documented burden of treatment. Across the trial, 61.5% demonstrated VPC and 38.5% VPI. Twenty-two percent of participants achieved age appropriate PCC-scores. There were no statistically significant differences between arms or centers for these measures. In the Danish center, arm B: achieved lower PCC-scores (P = .01); obtained PCC-scores without s-errors below 79% (P = .002); produced ≥3 active oral cleft speech characteristics (P = .004) than arm A. In both centers, arm B attended more speech visits. At age 5, differences between centers and treatment arms were not statistically significant for VPC/VPI, but consonant proficiency differed between treatment arms in the Danish center. Poor speech outcomes were seen for both treatment arms. Variations between centers were observed. As the Swedish center had few participants, intercenter comparisons should be interpreted with caution.

The effect of ticagrelor on growth of small abdominal aortic aneurysms-a randomized controlled trial.

To evaluate if ticagrelor, an effective platelet inhibitor without known non-responders, could inhibit growth of small abdominal aortic aneurysms (AAAs). In this multi-centre randomized controlled trial, double-blinded for ticagrelor and placebo, acetylic salicylic acid naïve patients with AAA and with a maximum aortic diameter 35-49 mm were included. The primary outcome was mean reduction in log-transformed AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months compared with baseline. Secondary outcomes include AAA-diameter growth rate and intraluminal thrombus (ILT) volume enlargement rate. A total of 144 patients from eight Swedish centres were randomized (72 in each group). MRI AAA volume increase was 9.1% for the ticagrelor group and 7.5% for the placebo group (P = 0.205) based on intention-to-treat analysis, and 8.5% vs. 7.4% in a per-protocol analysis (P = 0.372). MRI diameter change was 2.5 mm vs. 1.8 mm (P = 0.113), US diameter change 2.3 mm vs. 2.2 mm (P = 0.778), and ILT volume change 12.9% vs. 10.4% (P = 0.590). In this RCT, platelet inhibition with ticagrelor did not reduce growth of small AAAs. Whether the ILT has an important pathophysiological role for AAA growth cannot be determined based on this study due to the observed lack of thrombus modulating effect of ticagrelor. The TicAAA trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT02070653.

\u201cI have got diabetes!\u201d \u2013 interviews of patients newly diagnosed with type 2 diabetes

BackgroundTo be diagnosed with type 2 diabetes is a challenge for every patient. There are previous studies on patients’ experience in general but not addressing the increased cardiovascular risk and multifactorial treatment. The aim of this study was to explore the thoughts, experiences and reactions of newly diagnosed patients with diabetes to this diagnosis and to the risk of developing complications.MethodsTen adults (7 men/3 women, aged 50–79) diagnosed with type 2 diabetes within the last 12 months were interviewed at a primary health care center in Sweden. An interview guide was used in the semi-structured interviews that were transcribed verbatim. The analysis was qualitative and inspired by systematic text condensation (Malterud). The text was read several times and meaning units were identified. Related meaning units were sorted into codes and related codes into categories during several meetings between the authors. Finally, the categories were merged and formed themes.ResultsWe defined three main themes: Reaction to diagnosis, Life changes and Concerns about the future. Most patients reacted to the diagnosis without intensive feelings. Lifestyle changes were mainly accepted but hard to achieve. The patients’ major concerns for the future were the consequences for daily life (being able to drive and read) and concerns for relatives rather than anxieties regarding medical issues such as laboratory tests. There were considerable differences in how much patients wanted to know about their future risks.ConclusionsThe results of this study might help to focus doctor-patient communication on issues highlighted by the patients and on the importance of individualizing information and recommendations for each patient.

Agreement between patient reported outcomes and clinical reports after radical prostatectomy - a prospective longitudinal study

BackgroundIn clinical research information can be retrieved through various sources. The aim is to evaluate the agreement between answers in patient questionnaires and clinical reports in a study of patients after radical prostatectomy and patient characteristics associated with agreement between these two data sources.MethodsIn the prospective non-randomized longitudinal trial LAParoscopic Prostatectomy Robot Open (LAPPRO) 4003 patients undergoing radical prostatectomy at 14 centers in Sweden were followed. Analysis of agreement is made using a variety of methods, including the recently proposed Gwet’s AC1, which enables us to handle the limitations of Cohen’s Kappa where agreement depends on the underlying prevalence.ResultsThe incidence of postoperative events was consistently reported higher by the patient compared with the clinical reports for all outcomes. Agreement regarding the absence of events (negative agreement) was consistently higher than agreement regarding events (positive agreement) for all outcome variables. Overall impression of agreement depends on which measure used for the assessment. The previously reported desirable properties of Gwet’s AC1 as well as the patient characteristics associated with agreement were confirmed.ConclusionThe differences in incidence and agreement across the different variables and time points highlight the importance of carefully assessing which source of information to use in clinical research.Trial registrationISRCTN06393679 (www.isrctn.com). Date of registration: 07/02/2008. Retrospectively registered.

Evaluation for epilepsy surgery – Why do patients not proceed to operation?

PurposeTo investigate the reasons for not proceeding to surgery in patients undergoing presurgical evaluation for epilepsy. MethodsA retrospective cohort study of 401 consecutive patients who were evaluated for but did not proceed to surgery for epilepsy between 1990 and 2016 at three Swedish epilepsy surgery centers was performed. Reasons for not proceeding to surgery were categorized as inconclusive investigation, seizure onset within eloquent cortex, evidence of multiple seizure foci, infrequent seizures, risk of postoperative severe cognitive decline, patient or caregiver declining surgery or invasive investigation, severe psychiatric or somatic comorbidity, patient death during evaluation and complications during the evaluation. Chi-square tests were performed to compare ordered categorical variables. ResultsDuring the entire time period the main reasons for rejection were inconclusive investigation (34,4%) and multifocal seizure onset (20,0%). The risk for severe cognitive decline postoperatively was more often a cause for rejection in more recent years. Patients declining invasive EEG or surgery accounted for a minor but not insignificant proportion (14,2%) of rejections. ConclusionsInconclusive results from the presurgical evaluation and multifocal epilepsy were the main causes for not proceeding to surgery. The proportion of patients opting to abstain from surgery was low compared to other recent studies.

Implant Based Breast Reconstruction With Acellular Dermal Matrix: Safety Data From an Open-label, Multicenter, Randomized, Controlled Trial in the Setting of Breast Cancer Treatment.

To evaluate clinical outcomes of using acellular dermal matrix (ADM) with implant based breast reconstructions (IBBRs) in a randomized controlled trial. The use of ADMs in IBBRs is widespread, but link between ADM and complications remain a controversial topic. In view of reports concerning harm, we present 6-months safety data of ADM-assisted IBBR in the setting of breast cancer treatment. An open-label, randomized, controlled trial recruiting patients from 4 centers in Sweden and 1 in UK. Eligible were women with breast cancer planned for mastectomy with immediate IBBR. Participants were randomly allocated to IBBR with or without ADM (Strattice, Branchburg, NJ), with stratification by center in blocks of 6. Main primary endpoint was number of unplanned reoperations at 24 months, and safety expressed as the incidence of adverse events with a 6-month follow-up time for all participants. Analysis were done per protocol using Fisher exact test for complications and reoperations. From start of enrolment on April 24, 2014, to close of trial on May 10, 2017, 135 women were enrolled, of whom 64 with ADM and 65 without ADM were included in the final analysis. Four patients (6%) in each group had reconstructive failure with implant loss, but IBBR with ADM exhibited a trend of more overall complications and reoperations (difference 0·16, 95% CI, -0·01 to 0·32, P = 0·070), and with higher risk of wound healing problems (P = 0·013). With 6-months follow-up for all participants, immediate IBBR with ADM carried a risk of implant loss equal to conventional IBBR without ADM, but was associated with more adverse outcomes requiring surgical intervention. Further investigation of risk factors and patient selection in a long-term follow-up is warranted.