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  • 1. Bureau, Christophe
    et al.
    Adebayo, Danielle
    Chalret de Rieu, Mael
    Elkrief, Laure
    Valla, Dominique
    Peck-Radosavljevic, Markus
    McCune, Anne
    Vargas, Victor
    Simon-Talero, Macarena
    Cordoba, Juan
    Angeli, Paolo
    Rosi, Silvia
    MacDonald, Stewart
    Malago, Massimo
    Stepanova, Maria
    Younossi, Zobair M
    Trepte, Claudia
    Watson, Randall
    Borisenko, Oleg
    Sun, Sun
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Epidemiologi och global hälsa. Synergus AB, Danderyd, Sweden; Health Outcomes and Economic Evaluation Research Group, Department of Learning, Information, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.
    Inhaber, Neil
    Jalan, Rajiv
    Alfapump® system vs. large volume paracentesis for refractory ascites: a multicenter randomized controlled study2017Ingår i: Journal of Hepatology, ISSN 0168-8278, E-ISSN 1600-0641, Vol. 67, nr 5, s. 940-949Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background and aims: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with a poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump® [AP]) compared with LVP standard of care [SoC].

    Methods: A randomized controlled trial, in seven centers, with six month patient observation was conducted. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival. Nutrition, hemodynamics, and renal injury biomarkers were assessed in a sub-study at three months.

    Results: Sixty patients were randomized and 58 were analyzed (27 AP, 31 SoC, mean age 61.9years, mean MELD 11.7). Eighteen patients were included in the sub-study. Compared with SoC, median time to first LVP was not reached after six months in the AP group, meaning a significant reduction in LVP requirement for the AP patients (AP, median not reached; SoC, 15.0days (HR 0.13; 95%CI 13.0-22.0; p<0.001), and AP patients also showed significantly improved Chronic Liver Disease Questionnaire (CLDQ) scores compared with SoC patients (p<0.05 between treatment arms). Improvements in nutritional parameters were observed for hand-grip strength (p=0.044) and body mass index (p<0.001) in the sub-study. Compared with SoC, more AP patients reported adverse events (AEs; 96.3% vs. 77.4%, p=0.057) and serious AEs (85.2 vs. 45.2%, p=0.002). AEs consisted predominantly of acute kidney injury in the immediate post-operative period, and re-intervention for pump related issues, and were treatable in most cases. Survival was similar in AP and SoC.

    Conclusions: The AP system is effective for reducing the need for paracentesis and improving quality of life in cirrhotic patients with RA. Although the frequency of SAEs (and by inference hospitalizations) was significantly higher in the AP group, they were generally limited and did not impact survival.

    Lay summary: The alfapump® moves abdominal fluid into the bladder from where it is then removed by urination. Compared with standard treatment, the alfapump reduces the need for large volume paracentesis (manual fluid removal by needle) in patients with medically untreatable ascites. This can improve life quality for these patients.

  • 2. Du, Xiaoyang
    et al.
    Khamitova, Adina
    Kyhlstedt, Mattias
    Sun, Sun
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Epidemiologi och global hälsa. Department of Learning, Information, Management and Ethics, Karolinska Institutet, Stockholm, Sweden; Synergus AB, Stockholm, Sweden.
    Sengoelge, Mathilde
    Utilisation of real-world data from heart failure registries in OECD countries: a systematic review2018Ingår i: IJC Heart & Vasculature, ISSN 2352-9067, Vol. 19, s. 90-97Artikel, forskningsöversikt (Refereegranskat)
    Abstract [en]

    Background: Heart failure represents a major public health issue that impacts 26 million people globally. Currently, real-world data represents a key instrument for providing the verification of both internal and external validity, yet there is still a lack of understanding regarding its scope in complementing evidence of treatments for heart failure. This study aims to increase understanding of the utilisation of real-word data from heart failure registries in Organisation for Economic Co-operation and Development (OECD) countries.

    Method: This was a systematic review of existing observational studies from heart failure registries in 35 OECD member countries. Studies from 2000 to March 2017 were identified through electronic databases (MEDLINE (Ovid), EMBASE, Web of Science Core Collection, CINAHL (Ebsco), Cochrane CENTRAL) and appraised according to eligibility criteria.

    Results: Two-hundred and two studies met the inclusion criteria, in which the majority were published from 2013 to 2016. All 202 studies were observational, among which 98% were cohort studies (198). The median sample size of all studies was 5152 (2417 to 32,890) and median study period 55 months (33.0 to 72.0). Swedish heart failure registry had the most publications (24, 12%).

    Conclusion: Since 2000 there has been an upward trend in the number of published observational studies on heart failure registries in OECD countries with increasingly diverse outcomes and advanced statistical methods to improve their validity and reliability. This indicates that the utilisation of real-world data has experienced a significant upsurge in complementing the findings of clinical trials for improved research of heart failure treatments.

  • 3. Ren, Mengying
    et al.
    Fang, Xin
    Li, Mei
    Sun, Sun
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Epidemiologi och global hälsa. Health Outcomes and Economic Evaluation Research Group, Department of Learning, Information, Management and Ethics, Karolinska Institutet, 171 77 Stockholm, Sweden.
    Pei, Lu
    Xu, Qun
    Ye, Xiaofei
    Cao, Yang
    Concentration-response relationship between PM2.5 and daily respiratory deaths in China: a systematic review and metaregression analysis of time-series studies2017Ingår i: BioMed Research International, ISSN 2314-6133, E-ISSN 2314-6141, artikel-id 5806185Artikel, forskningsöversikt (Refereegranskat)
    Abstract [en]

    The association between the particulate matters with aerodynamic diameter <= 2.5.mu m (PM2.5) and daily respiratory deaths, particularly the concentration-response pattern, has not been fully examined and established in China. We conducted a systematic review of time-series studies to compile information on the associations between PM2.5 concentration and respiratory deaths and used metaregression to assess the concentration-response relationship. Out of 1,957 studies screened, eleven articles in English and two articles in Chinese met the eligibility criteria. For single-day lags, per 10 mu g/m(3) increase in PM2.5 concentration was associated with 0.30 [95% confidence interval (CI): 0.10, 0.50] percent increase in daily respiratory deaths; for multiday lags, the corresponding increase in respiratory deaths was 0.69 (95% CI: 0.55, 0.83) percent. Difference in the effects was observed between the northern cities and the south cities in China. No statistically significant concentration-response relationship between PM2.5 concentrations and their effects was found. With increasingly wider location coverage for PM2.5 data, it is crucial to further investigate the concentration-response pattern of PM2.5 effects on respiratory and other cause-specific mortality for the refinement and adaptation of global and national air quality guidelines and targets.

  • 4.
    Sun, Sun
    et al.
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Epidemiologi och global hälsa. Synergus AB, Kevinge Strand 20, 182 57 Stockholm, Sweden; Health Outcomes and Economic Evaluation Research Group, Center for Healthcare Ethics, Department of Learning, Information, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.
    Borisenko, Oleg
    Spelman, Tim
    Ahmed, Ahmed R.
    Patient Characteristics, Procedural and Safety Outcomes of Bariatric Surgery in England: a Retrospective Cohort Study 2006-20122018Ingår i: Obesity Surgery, ISSN 0960-8923, E-ISSN 1708-0428, Vol. 28, s. 1098-1108Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    The objective of the study is to analyze procedural and safety outcomes associated with bariatric surgery and describe the characteristics of patients undertaking bariatric procedures in England between April 2006 and March 2012. This is a retrospective cohort study of all adult patients in England diagnosed with obesity and undergoing bariatric surgery as a primary procedure in NHS-funded sites between April 2006 and March 2012 using data sourced from the Hospital Episode Statistics dataset. Length of stay (LOS), 30-day readmission, and post-surgery complication were analyzed as primary outcomes. Socio-demographic background, provider type, procedure volume, and comorbidities were all analyzed as potential explanatory variables. Gastric bypass (GBP, 12,628) was the most utilized procedure, followed by gastric banding (GB, 6872) and sleeve gastrectomy (SG, 3251). The most prevalent comorbidity was type 2 diabetes (23%). Inpatient mortality was low (≀ 0.15%) for all procedure types. LOS and the risks of both post-operative complication and 30-day readmission were significantly lower for GB, relative to those for GBP and SG. Ethnicity, geographical area, surgery type, and volume were all associated with LOS, risk of readmission, and complication. Provider type and deprivation were further associated with LOS while age correlated with readmission only. An increasing comorbidity burden was associated with an increased risk of both readmission and complication. Gastric bypass was the most frequently reported procedure in England across the observation period. While utilization across all procedure types increased between 2007 and 2010, overall uptake of bariatric surgery in England represents only a small proportion of the eligible population. Readmission and complication rates were lower for gastric banding relative to those for either gastric bypass or sleeve gastrectomy. The observed inpatient mortality rate was low across all procedure types.

  • 5. Zhuo, Lang
    et al.
    Xu, Ling
    Ye, Jingtao
    Sun, Sun
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Epidemiologi och global hälsa. Health Outcomes and Economic Evaluation Research Group, Stockholm, Sweden; Centre for Healthcare Ethics, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.
    Zhang, Yaoguang
    Burstrom, Kristina
    Chen, Jiaying
    Time Trade-Off Value Set for EQ-5D-3L Based on a Nationally Representative Chinese Population Survey2018Ingår i: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 21, nr 11, s. 1330-1337Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Objectives: To obtain a nationally representative Chinese three-level EuroQol five-dimensional questionnaire value set based on the time trade-off (TTO) method.

    Methods: A multistage, stratified, clustered random nationally representative Chinese sample was used. The study design followed an adapted UK Measurement and Valuation of Health protocol. Each respondent valued 11 random states plus state 33333 and "unconscious" using the TTO method in face-to-face interviews. Three types of models were explored: ordinary least squares, general least squares, and weighted least squares models.

    Results: In total, 5939 inhabitants aged 15 years and older were interviewed. Of these, 5503 satisfactorily interviewed participants were included in constructing models. An ordinary least squares model including 10 dummies without constant and N3 had a mean absolute error of 0.083 and a correlation coefficient of 0.899 between the predicted and mean values. Goodness-of-fit indices of two models based on split subsample were similar.

    Conclusions: TTO values were higher in our study compared with those in a study carried out in urban areas, which is mirrored by the higher values in rural areas. Several other aspects, in addition to the valuation procedure, might have influenced the results, such as factors beyond demographic factors such as view on life and death and believing in an afterlife, which need further investigation. Future studies using the three-level EuroQol five-dimensional questionnaire should consider using this value set based on a nationally representative sample of the Chinese population.

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