Peripheral Artery Disease Leading to Major Amputation: Trends in Revascularization and Mortality Over 18 Years.

BACKGROUND: Patients with peripheral artery disease (PAD) are at risk for amputation. The aim of this study was to assess the type of revascularization prior to and the 30-day mortality rate after major amputation due to PAD. METHODS: Retrospective analysis of consecutive patients undergoing major amputation for PAD between 01/2000 and 12/2017 at a tertiary referral center. The number and target level of ipsilateral revascularizations prior to amputation were analyzed per patient and over the years. There were 3 types of revascularization (open, endovascular and combined treatment) at 3 levels: aortoiliac, femoropopliteal and infrapopliteal. Univariate and multivariate logistic regression models were used to assess the association of level of amputation and patient characteristics with 30-day mortality. RESULTS: A total of 312 patients (65.7% male) with a mean age of 73.3 ± 11 years underwent 338 major amputations: 70 (21%) above/through knee and 268 (79%) below knee. A median of 2 (interquartile range, IQR 1-4) revascularizations were performed prior to amputation, with a slight decrease of 1.4% per year from 2000-2017 (incidence rate ratio of 0.986 0.974-0.998; Poisson regression analysis, P = 0.021). 16% (53/338) of patients underwent primary amputation without revascularization; this number remained relatively stable throughout the study period. The proportion of exclusively open treatment before amputation decreased substantially from 35% in 2006 to none in 2016, while exclusively endovascular revascularizations were performed increasingly from 17% in 2002 to 64% in 2016. Amputation occurred after a median of 9.5 months (IQR 0.9-67.6 months) if the first revascularization was aortoiliac or femoropopliteal and after 2.1 months (IQR 0.5-13.8 months) if the first intervention was infrapopliteal (P < 0.001) with no significant change over the years (normal linear regression, P= 0.887). Thirty-day mortality was 8.9% (22/247) after below knee and 27.7% (18/65) after above/through knee amputation (adjusted OR 3.84, 95% CI 1.74-8.54, P= 0.001) with a slight increase of mortality over the study period (adjusted OR 1.09, 95% CI 1.018-1.159, Poisson regression analysis, P= 0.021). The uni- and multivariate analysis of patient characteristics did not show an association with mortality, except higher ASA classification (adjusted OR 2.65, 95% CI 1.23-5.72, P= 0.012). CONCLUSIONS: Mortality, especially after above/through knee amputation, remains high over the past 2 decades. There is a clear shift towards endovascular treatment of patients with PAD prior to major amputation. In patients needing infrapopliteal revascularizations, amputation was performed much sooner than in those with aortoiliac or femoropopliteal interventions, with no improvement over the years. Strategies to extend limb salvage in these patients should be the focus of further research.

Breast shield design impacts milk removal dynamics during pumping: A randomized controlled non-inferiority trial.

INTRODUCTION: While many studies have investigated the importance of optimizing pumping patterns for milk removal, the influence of breast shield design on milk removal has not been the focus of extensive investigation. This study aimed to determine the effectiveness of breast shields with either a 105° or a 90° flange opening angle on breast drainage and milk volume expressed during pumping. MATERIAL AND METHODS: This study was a cross-over, randomized controlled non-inferiority trial (Registration; NCT03091985). Mothers (n = 49) of breastfeeding infants participated in the study over two study sessions. Participants were randomly assigned to pump both breasts simultaneously for 15 minutes with either the 105° or 90° breast shield in the first session, and the other shield in the second session. Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields were assessed after 15 minutes of pumping. Intention-to-treat and per protocol analyses were performed to determine if the 105° breast shield was non-inferior to the 90° breast shield for breast drainage and volume expressed. Perceived comfort was assessed via questionnaire. RESULTS: The 105° breast shield was both non-inferior and superior compared to the standard 90° shield for breast drainage (intention-to-treat, 3.87% (0.01-7.72), P = .049) and volume expressed (intention-to-treat, 9.14 mL (1.37-16.91), P=.02). In addition, the 105° shield was rated as feeling more comfortable (P < .001) and as having an improved fit to the breast (P < .001) compared to the 90° shield. CONCLUSIONS: Expressing with the 105° breast shield was more efficient, effective and comfortable compared to the 90° shield. Breast shield design can significantly impact pumping outcomes, and an opening angle of 105° improves both the dynamics and comfort of milk removal.

Large regional variation in cardiac closure procedures to prevent ischemic stroke in Switzerland a population-based small area analysis.

BACKGROUND: Percutaneous closure of a patent foramen ovale (PFO) or the left atrial appendage (LAA) are controversial procedures to prevent stroke but often used in clinical practice. We assessed the regional variation of these interventions and explored potential determinants of such a variation. METHODS: We conducted a population-based analysis using patient discharge data from all Swiss hospitals from 2013-2018. We derived hospital service areas (HSAs) using patient flows for PFO and LAA closure. We calculated age-standardized mean procedure rates and variation indices (extremal quotient [EQ] and systematic component of variation [SCV]). SCV values >5.4 indicate a high and >10 a very high variation. Because the evidence on the efficacy of PFO closure may differ in patients aged <60 years and ≥60 years, age-stratified analyses were performed. We assessed the influence of potential determinants of variation using multilevel regression models with incremental adjustment for demographics, cultural/socioeconomic, health, and supply factors. RESULTS: Overall, 2574 PFO and 2081 LAA closures from 10 HSAs were analyzed. The fully adjusted PFO and LAA closure rates varied from 3 to 8 and from 1 to 9 procedures per 100,000 persons per year across HSAs, respectively. The regional variation was high with respect to overall PFO closures (EQ 3.0, SCV 8.3) and very high in patients aged ≥60 years (EQ 4.0, SCV 12.3). The variation in LAA closures was very high (EQ 16.2, SCV 32.1). In multivariate analysis, women had a 28% lower PFO and a 59% lower LAA closure rate than men. French/Italian language areas had a 63% lower LAA closure rate than Swiss German speaking regions and areas with a higher proportion of privately insured patients had a 86% higher LAA closure rate. After full adjustment, 44.2% of the variance in PFO closure and 30.3% in LAA closure remained unexplained. CONCLUSIONS: We found a high to very high regional variation in PFO closure and LAA closure rates within Switzerland. Several factors, including sex, language area, and insurance status, were associated with procedure rates. Overall, 30-45% of the regional procedure variation remained unexplained and most probably represents differing physician practices.

Cognition after a 4-week high phenylalanine intake in adults with phenylketonuria - a randomized controlled trial.

BACKGROUND: Phenylketonuria (PKU) is an autosomal recessive metabolic disorder characterized by increased phenylalanine (Phe) concentrations in the blood and brain. Despite wide agreement on treatment during childhood, recommendations for adults are still controversial. OBJECTIVE: To assess the impact of a 4-week increase in Phe intake (simulating normal dietary Phe consumption) on cognition, mood, and depression in early-treated adults with PKU in a double-blind, randomized controlled trial (RCT). METHODS: In a single-site crossover trial, 30 adult patients with classical PKU diagnosed at birth were recruited. All patients underwent a 4-week period of oral Phe administration (1500-3000 mg Phe/d) and a 4-week placebo period in a randomly assigned order with age, sex, and place of usual medical care as stratification factors. Analyses were based on the intention-to-treat (ITT) and per protocol (PP) approach to claim noninferiority (noninferiority margin -4%), with working memory accuracy as the primary endpoint and additional cognitive domains, mood, and depression as secondary endpoints. RESULTS: For the primary endpoint, a 4-week increase of Phe intake was noninferior to placebo with respect to working memory accuracy in both the ITT [point estimate 0.49; lower limit 95% confidence interval (CI): -1.99] and the PP analysis (point estimate -1.22; lower limit 95% CI: -2.60). Secondary outcomes (working memory reaction time, manual dexterity, mood, and depression) did not significantly differ between the Phe and placebo period, except for sustained attention (point estimate 31.0; lower limit 95% CI: 9.0). Adverse events were more frequent during the Phe than during the placebo period (95% CI: 1.03, 2.28, P = 0.037). CONCLUSIONS: In early-treated adult patients with PKU, a 4-week high Phe intake was noninferior to continuing Phe restriction regarding working memory accuracy, and secondary outcomes did not differ except for sustained attention. Longer-term RCTs are required to determine whether low Phe levels need to be maintained throughout different periods of adulthood. This trial was registered at the clinicaltrials.gov as NCT03788343.

Regional variation and temporal trends in transcatheter and surgical aortic valve replacement in Switzerland: A population-based small area analysis.

BACKGROUND: Aortic valve stenosis (AS) is the most common valvular heart disease and if severe, is treated with either transcatheter (TAVR) or surgical aortic valve replacement (SAVR). We assessed temporal trends and regional variation of these interventions in Switzerland and examined potential determinants of geographic variation. METHODS: We conducted a population-based analysis using patient discharge data from all Swiss public and private acute care hospitals from 2013 to 2018. We generated hospital service areas (HSAs) based on patient flows for TAVR. We calculated age-standardized mean procedure rates and variation indices (extremal quotient [EQ] and systematic component of variation [SCV]). Using multilevel regression, we calculated the influence of calendar year and regional demographics, socioeconomic factors (language, insurance status), burden of disease, and number of cardiologists/cardiovascular surgeons on geographic variation. RESULTS: Overall, 8074 TAVR and 11,825 SAVR procedures were performed in 8 HSAs from 2013 to 2018. Whereas the age-/sex-standardized rate of TAVR increased from 12 to 22 procedures/100,000 persons, the SAVR rate decreased from 33 to 24 procedures during this period. After full adjustment, the predicted TAVR and SAVR rates varied from 12 to 22 and 20 to 35 per 100,000 persons across HSAs, respectively. The regional procedure variation was low to moderate over time, with a low overall variation in TAVR (EQ 1.9, SCV 3.9) and SAVR (EQ 1.6, SCV 2.2). In multilevel regression, TAVR rates increased annually by 10% and SAVR rates decreased by 5%. Determinants of higher TAVR rates were older age, male sex, living in a German speaking area, and higher burden of disease. A higher proportion of (semi)private insurance was also associated with higher TAVR and lower SAVR rates. After full adjustment, 10.6% of the variance in TAVR and 18.4% of the variance in SAVR remained unexplained. Most variance in TAVR and SAVR rates was explained by language region and insurance status. CONCLUSION: The geographic variation in TAVR and SAVR rates was low to moderate across Swiss regions and largely explained by differences in regional demographics and socioeconomic factors. The use of TAVR increased at the expense of SAVR over time.

Adherence to thrombophilia testing guidelines and its influence on anticoagulation therapy: A single-center cross-sectional study.

INTRODUCTION: The collected evidence on thrombophilia guidelines is scarce and data about their impact on clinical decisions are unknown. We aimed to investigate the adherence to thrombophilia testing guidelines, its therapeutic impact in patients with guideline-adherent and non-adherent testing and identify the patients' clinical characteristics mostly associated with treatment decisions. MATERIALS AND METHODS: We conducted a single-center cross-sectional study of patients referred for thrombophilia testing at the outpatient clinic of a tertiary hospital between 01/2010-10/2020. We systematically evaluated the adherence of thrombophilia testing to internal guidelines and the influence of test results on anticoagulation therapy. Using multivariable logistic regression, we evaluated the association between clinical characteristics and influence of thrombophilia tests on anticoagulation therapy in the entire cohort and by indication for referral. RESULTS: Of 3686 included patients, mostly referred for venous thromboembolism (2407, 65 %) or arterial thrombosis (591, 16 %), 3550 patients (96 %) underwent thrombophilia testing. Indication for testing was according to guidelines in 1208 patients (33 %). Test results influenced treatment decisions in 56 of 1102 work-ups (5.1 %) that were adherent to guidelines, and in 237 of 2448 (9.7 %) non-adherent work-ups (absolute difference, 4.3 %; 95 % confidence interval, 2.9-6.3 %). Age < 50 years, female sex, absence of risk factors and co-morbidities, weakly provoked venous thromboembolism and referral indication other than venous thromboembolism were associated with influence on anticoagulation therapy. CONCLUSIONS: Adherence to guidelines for thrombophilia testing was poor and did not have an impact on treatment decisions. Refinement of selection criteria is needed to increase the therapeutic impact of thrombophilia testing.

Variation in regional implantation patterns of cardiac implantable electronic device in Switzerland.

INTRODUCTION: There is a substantial geographical variation in the rates of pacemaker (PM), implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) device implantation across European countries. We assessed the extent of regional variation and potential determinants of such variation. METHODS: We conducted a population-based analysis using discharge data for PM/ICD/CRT implantations from all Swiss acute care hospitals during 2013-2016. We derived hospital service areas (HSA) by analyzing patient flows. We calculated age- and sex-standardized rates and quantified variation using the extremal quotient (EQ) and the systemic component of variation (SCV). We estimated the reduction in variance of crude implantation rates across HSAs using multilevel regression models, with incremental adjustment for age and sex, language, socioeconomic factors, population health, diabetes mellitus, and the density of cardiologists on the HSA level. RESULTS: We analyzed implantations of 8129 PM, 1461 ICD, and 1411 CRT from 25 Swiss HSAs. The mean age- and sex-standardized implantation rate was 29 (range 8-57) per 100,000 persons for PM, 5 (1-9) for ICD, and 5 (2-8) for CRT. There was a very high variation in PM (EQ 7.0; SCV 12.6) and ICD (EQ 7.2; SCV 11.3) and a high variation in CRT implantation rates (EQ 3.9; SCV 7.1) across HSAs. Adjustments for age and sex, language, socioeconomic factors, population health, diabetes mellitus, and density of cardiologists explained 94% of the variance in ICD and 87.5% of the variance in CRT implantation rates, but only 36.3% of the variance in PM implantation rates. Women had substantially lower PM/ICD/CRT implantation rates than men. CONCLUSION: Switzerland has a very high regional variation in PM/ICD implantation and a high variation in CRT implantation rates. Women had substantially lower implantation rates than men. A large share of the variation in PM procedure rates remained unexplained which might reflect variations in physicians' preferences and practices.

Development of an electronic Poor Outcome Screening (ePOS) Score to identify critically ill patients with potential palliative care needs.

PURPOSE: To develop and validate an electronic poor outcome screening (ePOS) score to identify critically ill patients with potentially unmet palliative care (PC) needs at 48 hours after ICU admission. MATERIALS AND METHODS: Retrospective single-centre cohort study of 1'772 critically ill adult patients admitted to a tertiary academic ICU in Switzerland between 2017 and 2018. We used data available from electronic health records (EHR) in the first 48 hours and least absolute shrinkage and selection operator (LASSO) logistic regression to develop a prediction model and generate a score to predict the risk of all cause 6-month mortality. RESULTS: Within 6 months of the ICU admission, 598 patients (33.7%) had died. At a cut-off of 20 points, the ePOS score (range 0-46 points) had a sensitivity of 0.81 (95% CI 0.78 to 0.84) and a specificity of 0.51 (0.48 to 0.54) for predicting 6-month mortality and showed good discriminatory performance (AUROC 0.72, 0.67 to 0.77). CONCLUSIONS: The ePOS score can easily be implemented in EHR and can be used for automated screening and stratification of ICU patients, pinpointing those in whom a comprehensive PC assessment should be performed. However, it should not replace clinical judgement.

Thrombophilia Impact on Treatment Decisions, Subsequent Venous or Arterial Thrombosis and Pregnancy-Related Morbidity: A Retrospective Single-Center Cohort Study.

(1) Background: Thrombophilia testing utility has remained controversial since its clinical introduction, because data on its influence on treatment decisions are limited. (2) Methods: We conducted a single-center retrospective cohort study of 3550 unselected patients referred for thrombophilia consultation at the Bern University Hospital in Switzerland from January 2010 to October 2020. We studied the influence of thrombophilia testing results on treatment decisions and evaluated the association between thrombophilia and thromboembolic and pregnancy-related morbidity events after testing up to 03/2021. (3) Results: In 1192/3550 patients (34%), at least one case of thrombophilia was found and 366 (10%) had high-risk thrombophilia. A total of 211/3550 (6%) work-ups (111/826 (13%) with low-risk thrombophilia and 100/366 (27%) with high-risk thrombophilia) led to an appropriate decision to extend or initiate anticoagulation, and 189 (5%) negative results led to the withholding of anticoagulation therapy inappropriately. A total of 2492 patients (69%) were followed up for >30 days, with a median follow-up of 49 months (range, 1−183 months). Patients with high-risk thrombophilia had a higher risk of subsequent venous thromboembolic events and pregnancy-related morbidity compared to those without thrombophilia. (4) Conclusions: Our study demonstrated the limited usefulness of thrombophilia work-up in clinical decision-making. High-risk thrombophilia was associated with subsequent venous thromboembolism and pregnancy-related morbidity.

High regional variation in prostate surgery for benign prostatic hyperplasia in Switzerland.

BACKGROUND: Among various treatment options for benign prostatic hyperplasia (BPH), surgical therapy is the most invasive. As Switzerland has the highest transurethral prostatectomy rate among OECD countries, we assessed the regional variation in prostate surgery for BPH and explored potential determinants of variation. METHODS: We conducted a population-based analysis using discharge data for men aged ≥40 years with transurethral or simple prostatectomy from all Swiss hospitals during 2013-2018. After excluding patients with genitourinary/prostate cancer, we derived hospital service areas (HSAs) by analyzing patient flows. We calculated age-standardized mean procedure rates and variation indices (extremal quotient [EQ] and systematic component of variation [SCV]). We estimated the reduction in variance across HSAs of prostatectomy rates in multilevel regression models, with incremental adjustment for age, regional cultural and socioeconomic factors, disease burden, density of urologists, and the time since urologists' graduation. RESULTS: Overall, 44,253 prostatectomies (42,710 transurethral and 1543 simple) from 44 HSAs were analyzed. The mean age-standardized prostate surgery rate was 314 (range 166-500) per 100,000 men aged ≥40 years per year. The EQ was 3.01 and the SCV 5.53, indicating a high regional variation. In multivariate models, men aged 75-79 years had an 11.6-fold higher prostatectomy rate than those aged 50-54 years. French/Italian language areas had a 21% lower rate than Swiss German speaking areas. Socioeconomic factors, disease burden, and density of urologist/time since graduation were not associated with prostatectomy rates. After full adjustment, 80% of the variance in prostate surgery across HSAs remained unexplained. CONCLUSION: We found a remarkably high regional variation in prostate surgery rates for BPH within Switzerland.

Signet ring, high grade, and undifferentiated colorectal adenocarcinomas differ.

BACKGROUND: Studies with limited sample sizes have found colorectal signet ring carcinoma (SRC), to be prognostically similar to high grade adenocarcinoma (HGA); the relationship of these tumors to undifferentiated adenocarcinoma (UND) has not yet been fully elucidated. This study of Surveillance, Epidemiology, and End Results (SEER) program data compared the histotypes. METHODS: Registered as having been diagnosed between 1988 and 2003 were 2,246 SRC, 32,999 HGA, and 920 UND. Analyses were performed to determine the presence or absence of differences in survival and extent at presentation. RESULTS: SRC, compared with HGA, was more likely to (1) be confined to an in situ stage or within a polyp, (2) have invaded visceral peritoneum, (3) have spread to contiguous organs, and (4) have metastasized. No differences between SRC and UND were seen, although this may have been due to small UND sample size. SRC was associated with a worse prognosis than HGA for patients with (1) T3 tumors, (2) contiguous organ spread, and (3) visceral peritoneal invasion. UND was associated with a worse prognosis than SRC among patients with metastases. CONCLUSIONS: These three histotypes of aggressive colorectal cancer are separate entities that should be regarded as such. Future study with respect to SRC should include further evaluation of T1 and T2 patients with appropriate sample size populations and the potential utility of peritoneal sampling and frozen section evaluation of non-mucosal margins.

Automated delineation of hospital service areas as a new tool for health care planning.

OBJECTIVE: To develop an automated, reproducible method for delineating hospital service areas (HSAs). DATA SOURCES/SETTING: Discharge data from all Swiss acute care hospitals for the years 2013 to 2016. STUDY DESIGN: We derived HSAs and hospital referral regions for Switzerland using a newly developed flow-based, automated, objective, and reproducible method using all discharge data. We compared our method to the classical, partially subjective approach used to delineate the Swiss Health Care Atlas by delineating four sets of intervention-specific HSAs. PRINCIPAL FINDINGS: Based on 4 105 885 discharges, the fully automated method delineated 63 HSAs. Comparison with existing HSAs reveals good overlap and comparable measures of health utilization between the methods and shows that in the Swiss setting, our method outperforms a cluster-based approach to defining HSAs. While the classical method potentially takes an entire day to delineate the regions, our method took approximately 10 minutes. CONCLUSIONS: Hospital service areas are used to analyze differences in use of health care that may indicate underuse and overuse. Our new, fully automated, objective, and reproducible method provides a useful tool for hospital services researchers that will enable them to delineate and update patient-flow-based HSAs.

Regional variation of hysterectomy for benign uterine diseases in Switzerland.

BACKGROUND: Hysterectomy is the last treatment option for benign uterine diseases, and vaginal hysterectomy is preferred over more invasive techniques. We assessed the regional variation in hysterectomy rates for benign uterine diseases across Switzerland and explored potential determinants of variation. METHODS: We conducted a population-based analysis using patient discharge data from all Swiss hospitals between 2013 and 2016. Hospital service areas (HSAs) for hysterectomies were derived by analyzing patient flows. We calculated age-standardized mean procedure rates and measures of regional variation (extremal quotient [EQ], highest divided by lowest rate) and systematic component of variation [SCV]). We estimated the reduction in the variance of crude hysterectomy rates across HSAs in multilevel regression models, with incremental adjustment for procedure year, age, cultural/socioeconomic factors, burden of disease, and density of gynecologists. RESULTS: Overall, 40,211 hysterectomies from 54 HSAs were analyzed. The mean age-standardized hysterectomy rate was 298/100,000 women (range 186-456). While the variation in overall procedure rate was moderate (EQ 2.5, SCV 3.7), we found a very high procedure-specific variation (EQ vaginal 5.0, laparoscopic 6.3, abdominal 8.0; SCV vaginal 17.5, laparoscopic 11.2, abdominal 16.9). Adjusted for procedure year, demographic, cultural, and sociodemographic factors, a large share (64%) of the variance remained unexplained (vaginal 63%, laparoscopic 85%, abdominal 70%). The main determinants of variation were socioeconomic/cultural factors. Burden of disease and the density of gynecologists was not associated with procedure rates. CONCLUSIONS: Switzerland has a very high regional variation in vaginal, laparoscopic, and abdominal hysterectomy for benign uterine disease. After adjustment for potential determinants of variation including demographic factors, socioeconomic and cultural factors, burden of disease, and the density of gynecologists, two thirds of the variation remain unexplained.

Regional variation in hip and knee arthroplasty rates in Switzerland: A population-based small area analysis.

BACKGROUND: Compared to other OECD countries, Switzerland has the highest rates of hip (HA) and knee arthroplasty (KA). OBJECTIVE: We assessed the regional variation in HA/KA rates and potential determinants of variation in Switzerland. METHODS: We conducted a population-based analysis using discharge data from all Swiss hospitals during 2013-2016. We derived hospital service areas (HSAs) by analyzing patient flows. We calculated age-/sex-standardized procedure rates and measures of variation (the extremal quotient [EQ, highest divided by lowest rate] and the systemic component of variation [SCV]). We estimated the reduction in variance of HA/KA rates across HSAs in multilevel regression models, with incremental adjustment for procedure year, age, sex, language, urbanization, socioeconomic factors, burden of disease, and the number of orthopedic surgeons. RESULTS: Overall, 69,578 HA and 69,899 KA from 55 HSAs were analyzed. The mean age-/sex-standardized HA rate was 265 (range 179-342) and KA rate was 256 (range 186-378) per 100,000 persons and increased over time. The EQ was 1.9 for HA and 2.5 for KA. The SCV was 2.0 for HA and 2.2 for KA, indicating a low variation across HSAs. When adjusted for procedure year and demographic, cultural, and sociodemographic factors, the models explained 75% of the variance in HA and 63% in KA across Swiss HSAs. CONCLUSION: Switzerland has high HA/KA rates with a modest regional variation, suggesting that the threshold to perform HA/KA may be uniformly low across regions. One third of the variation remained unexplained and may, at least in part, represent differing physician beliefs and attitudes towards joint arthroplasty.

Data management of clinical trials during an outbreak of Ebola virus disease.

INTRODUCTION: Clinical trial data management (DM) conducted during outbreaks like that of Ebola virus disease (EVD) in West Africa, 2014-2016, has to adapt to specific, unique circumstances. CTU Bern was asked to set up a safe data capture/management system that could be launched within a few weeks and cover two different vaccine trials. This article describes some of the challenges we faced and our solutions during the two different trials. METHODS: Setting up a DM system was split into four phases/tasks: (1) quick set-up of the (electronic) data capture system (EDC) and mobile infrastructure in Bern, (2) moving the EDC and infrastructure to Conakry, Guinea and implementation of a local data management centre (DMC), (3) running the DMC, and (4) data cleaning. The DMC had to meet the following criteria: (1) quick implementation, (2) efficient maintenance and handling of data, and (3) procedures to guarantee data quality. The EDC (REDCap) was setup as a local area network. In order to ensure high data quality, double data entry, and then review of inconsistencies and offline plausibility checks were implemented. RESULTS: From the start of CTU Bern's involvement to the productive EDC took 11 weeks. It was necessary to adapt processes for dealing with data continuously throughout the trial conduct phase. The data management team processed 171,794 case report form pages from a total of 14,203 participants in the period between March and December 2015. CONCLUSION: Data management is a key task supporting trial conduct. For trials in emergency situations, many of our approaches are suitable, but we also provide a list of aspects that might be done differently.

The Swiss Narcolepsy Scale (SNS) and its short form (sSNS) for the discrimination of narcolepsy in patients with hypersomnolence: a cohort study based on the Bern Sleep-Wake Database.

Previous studies reported high sensitivity and specificity of the Swiss Narcolepsy Scale (SNS) for the diagnosis of narcolepsy type 1. We used data from the Bern Sleep-Wake Database to investigate the discriminating capacity of both the SNS and the Epworth Sleepiness Scale (ESS) to identify narcolepsy type 1 and type 2 in patients with central disorders of hypersomnolence (CDH) or sleepy patients with obstructive sleep apnea (OSA). In addition, we aimed to develop a simplified version of the SNS. We created the two-item short-form SNS (sSNS), based on the discriminative capability of the models including all possible combinations of the five questions of the SNS. Using the previously published co-efficiencies, we confirmed the high capacity of the SNS in identifying narcolepsy type 1. The updated SNS (based on new co-efficiencies and cutoff) and the sSNS showed high capacity and were both superior to ESS in identifying narcolepsy type 1. The sSNS correlated significantly with the SNS (r = - 0.897, p < 0.001). No scale showed sufficient discrimination for narcolepsy type 2. This is the largest cohort study that confirms the discriminating power of SNS for narcolepsy type 1 in patients with hypersomnolence and the first study to assess its discriminative power for narcolepsy type 2. The easy-to-use and easy-to-calculate short-form scale has a high discriminating power for narcolepsy type 1 and may be used as screening tool, especially among general practitioners, to identify patients and accelerate their referral to a center of expertise.

Prevalence of sleep-disordered breathing after stroke and TIA: A meta-analysis.

OBJECTIVE: To perform a systematic review and meta-analysis on the prevalence of sleep-disordered breathing (SDB) after stroke. METHODS: We searched PubMed, Embase (Ovid), the Cochrane Library, and CINAHL (from their commencements to April 7, 2017) for clinical studies reporting prevalence and/or severity of SDB after stroke or TIA. Only sleep apnea tests performed with full polysomnography and diagnostic devices of the American Academy of Sleep Medicine categories I-IV were included. We conducted random-effects meta-analysis. PROSPERO registration number: CRD42017072339. RESULTS: The initial search identified 5,211 publications. Eighty-nine studies (including 7,096 patients) met inclusion criteria. Fifty-four studies were performed in the acute phase after stroke (after less than 1 month), 23 studies in the subacute phase (after 1-3 months), and 12 studies in the chronic phase (after more than 3 months). Mean apnea-hypopnea index was 26.0/h (SD 21.7-31.2). Prevalence of SDB with apnea-hypopnea index greater than 5/h and greater than 30/h was found in 71% (95% confidence interval 66.6%-74.8%) and 30% (95% confidence interval 24.4%-35.5%) of patients, respectively. Severity and prevalence of SDB were similar in all examined phases after stroke, irrespective of the type of sleep apnea test performed. Heterogeneity between studies (I 2) was mostly high. CONCLUSION: The high prevalence of SDB after stroke and TIA, which persists over time, is important in light of recent studies reporting the (1) feasibility and (2) efficacy of SDB treatment in this clinical setting.

Long-term oxygen therapy in COPD patients: population-based cohort study on mortality.

Purpose: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide and is associated with a growing and substantial socioeconomic burden. Long-term oxygen therapy (LTOT), recommended by current treatment guidelines for COPD patients with severe chronic hypoxemia, has shown to reduce mortality in this population. The aim of our study was to assess the standardized mortality ratios of incident and prevalent LTOT users and to identify predictors of mortality. Patients and methods: We conducted a 2-year follow-up population-based cohort study comprising all COPD patients receiving LTOT in the canton of Bern, Switzerland. Comparing age- and sex-adjusted standardized mortality ratios, we examined associations between all-cause mortality and patient characteristics at baseline. To avoid immortal time bias, data for incident (receiving LTOT <6 months) and prevalent users were analyzed separately. Results: At baseline, 475 patients (20% incident users, n=93) were receiving LTOT because of COPD (48/100,000 inhabitants). Mortality of incident and prevalent LTOT users was 41% versus 27%, respectively, p<0.007, and standardized mortality ratios were 8.02 (95% CI: 5.64-11.41) versus 5.90 (95% CI: 4.79-7.25), respectively. Type 2 respiratory failure was associated with higher standardized mortality ratios among incident LTOT users (60.57, 95% CI: 11.82-310.45, p=0.038). Conclusion: Two-year mortality rate of COPD patients on incident LTOT was somewhat lower in our study than in older cohorts but remained high compared to the general population, especially in younger patients receiving LTOT <6 months. Type 2 respiratory failure was associated with mortality.

Unwarranted regional variation in vertebroplasty and kyphoplasty in Switzerland: A population-based small area variation analysis.

BACKGROUND: Percutaneous vertebroplasty (VP) and balloon kyphoplasty (BKP) for treating painful osteoporotic vertebral fractures are controversial. OBJECTIVE: We assessed the regional variation in the use of VP/BKP in Switzerland. METHODS: We conducted a population-based small area variation analysis using patient discharge data for VP/BKP from all Swiss hospitals and Swiss census data for calendar years 2012/13. We derived hospital service areas (HSAs) by analyzing patient flows, assigning regions from which most residents were discharged to the same VP/BKP specific HSA. We calculated age-/sex-standardized mean VP/BKP-rates and measures of regional variation (extremal quotient [EQ], systematic component of variation [SCV]). We estimated the reduction in variation of VP/BKP rates using negative binomial regression, with adjustment for patient demographic and regional socioeconomic factors (socioeconomic status, urbanization, and language region). We considered the residual, unexplained variation most likely to be unwarranted. RESULTS: Overall, 4955 VP/BKPs were performed in Switzerland in 2012/13. The age-/sex-standardized mean VP/BKP rate was 4.6/10,000 persons and ranged from 1.0 to 10.1 across 26 HSAs. The EQ was 10.2 and the SCV 57.6, indicating a large variation across VP/BKP specific HSAs. After adjustment for demographic and socioeconomic factors, the total reduction in variance was 32.2% only, with the larger part of the variation remaining unexplained. CONCLUSIONS: We found a 10-fold variation in VP/BKP rates across Swiss VP/BKP specific HSAs. As only one third of the variation was explained by differences in patient demographics and regional socioeconomic factors, VP/BKP in the highest-use areas may, at least partially, represent overtreatment.

Patency of the arterial pedal-plantar arch in patients with chronic kidney disease or diabetes mellitus.

BACKGROUND: Patency of the pedal-plantar arch limits risk of amputation in peripheral artery disease (PAD). We examined patients without chronic kidney disease (CKD)/diabetes mellits (DM) [PAD-control], those with DM without CKD, and those with CKD without DM. METHOD: Uni- and multivariate logistic regression was used to assess association of CKD with loss of patency of the pedal-plantar arch and presence of tibial or peroneal vessel occlusion. Multivariate models adjusted for age, sex, hypertension, hyperlipidemia and smoking. RESULTS: A total of 419 patients were included [age 75.2 ± 10.3 years, 288 (69%) male]. CKD nearly doubled the unadjusted odds ratio (OR) for loss of patency of the pedal-plantar arch. After adjustment, association remained significant for severe CKD [estimated glomerular filtration rate (eGFR) ≤ 29 ml/min compared with eGFR ≥ 60 ml/min, adjusted (adj.) OR 8.24 (95% confidence interval {CI} 0.99-68.36, p = 0.05)]. CKD was not related to risk of tibial or peroneal artery occlusion [PAD-control versus CKD, adj. OR 1.09 (95% CI 0.49-2.44, p = 0.83)] in contrast to DM [PAD-control versus DM, adj. OR 2.41 (95% CI 1.23-4.72, p = 0.01), CKD versus DM, adj. OR 2.21 (95% CI 0.93-5.22); p = 0.07)]. CONCLUSIONS: Below the knee (BTK) vascular pattern differs in patients with either DM or CKD alone. Severe CKD is a risk factor for loss of patency of the pedal-plantar arch.