| 1. |
- Semb, Gunvor, et al.
(författare)
-
A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.
- 2017
-
Ingår i: Journal of Plastic Surgery and Hand Surgery. - : Taylor & Francis. - 2000-656X .- 2000-6764. ; 51:1, s. 2-13
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND AIMS: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project.METHOD: Ten established national or regional cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes.RESULTS: Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years.CONCLUSION: The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point are described in the series.TRIAL REGISTRATION: ISRCTN29932826.
|
|
| 2. |
- Arvidsson, Matilda, 1976, et al.
(författare)
-
Theoretical and Methodological Approaches to Gender and International Law
- 2022
-
Ingår i: Oxford Bibliographies in International Law. - Oxford : Oxford Universitty Press.
-
Bokkapitel (övrigt vetenskapligt/konstnärligt)abstract
- ‘Gender’ as a specific topic of concern appeared gradually within international law and scholarship, initially by scholars drawing on feminist theories. A central concern in the scholarship is how gender relates to sex. For some scholars, gender is useful for distinguishing social constructions from biological sex. For others, this distinction is problematic as it conceals the way sex is also socially constructed. Reflecting these scholarly debates, the way gender is defined and relates to sex is not consistent in international legal instruments or scholarship. Another dividing question is how gender, sex, and ‘women’s situation’ relate. For some, gender means a focus on women. This conflation is questioned by others. The gender/woman question injects confusion and political force in international legal debates. More recently, gender identity has attracted attention, and while gender equality has long been a central topic of concern, states and scholars critical of what they consider ‘gender ideology’ in instruments such as the Yogyakarta Principles and the Istanbul Convention, have sought to advance ‘gender complementarity’ in its stead. For scholars committed to gender equality, ‘gender complementarity’ is conceived of as a backlash. These topics of concern do not reflect any specific theoretical or methodological approach and it is not possible to divide the theoretical and methodological approaches according to topic. Instead, the debates are pursued in a variety of ways: An early approach that remains significant seeks to identify structural biases in seemingly neutral or universal instruments. This can be contrasted to scholarship analyzing international instruments explicitly engaging with gender, the way international law partakes in forming gendered subjects, and processes of gender mainstreaming. The role of gender in gender based violence continues to be questioned. More recently, queer approaches have sought to question the normative in international law, and a theoretical focus on men and masculinity has emerged as a response to the focus on women in gender and international law debates. Aiming at granularity and ‘localizing’ gender, anthropological and ethnographic approaches contribute with narratives breaking with universalizing tendencies in international law. Similarly, intersectional, TWAIL and posthuman feminist debates approach gender as part of broader concerns, while some scholas have turned to history in order to rethink gendered aspects of international law. Natural science methods, including emerging technologies such as AI, are also used to analyze gender concerns. How gender is debated, analyzed, and questioned through different methodological and theoretical approaches demonstrate the political vibrancy of gender as a concept in international law.
|
|
| 3. |
- Asowed, Mustafa, et al.
(författare)
-
Activity and safety of KEES-an oral multi-drug chemo-hormonal metronomic combination regimen in metastatic castration-resistant prostate cancer
- 2023
-
Ingår i: BMC Cancer. - : BioMed Central (BMC). - 1471-2407. ; 23
-
Tidskriftsartikel (refereegranskat)abstract
- Background: Metastatic castration-resistant prostate cancer (mCRPC) remains a therapeutic challenge and evidence for late-line treatments in real-life is limited. The present study investigates the efficacy and safety of an oral metronomic chemo-hormonal regimen including cyclophosphamide, etoposide, estramustine, ketoconazole and prednisolone (KEES) administered in a consecutive biweekly schedule.Methods: A retrospective cohort study in two Swedish regions was conducted. Overall (OS) and progression-free survival (PFS), biochemical response rate (bRR) and toxicities were analyzed.Results: One hundred and twenty-three patients treated with KEES after initial treatment with at least a taxane or an androgen-receptor targeting agents (ARTA) were identified. Of those, 95 (77%) had received both agents and were the primary analysis population. Median (95% CI) OS and PFS in the pre-treated population were 12.3 (10.1-15.0) and 4.4 (3.8-5.5) months, respectively. Biochemical response, defined as >= 50% prostate-specific antigen (PSA) reduction, occurred in 26 patients (29%), and any PSA reduction in 59 (65%). PFS was independent of prior treatments used, and KEES seemed to be effective in late treatment lines. The bRR was higher compared to historical data of metronomic treatments in docetaxel and ARTA pre-treated populations. In multivariable analyses, performance status (PS) >= 2 and increasing alkaline phosphatase (ALP) predicted for worse OS. Nausea, fatigue, thromboembolic events and bone marrow suppression were the predominant toxicities.Conclusions: KEES demonstrated meaningful efficacy in heavily pre-treated CRPC patients, especially those with PS 0-1 and lower baseline ALP, and had an acceptable toxicity profile.
|
|
| 4. |
- Cheng, Qing, et al.
(författare)
-
Preclinical PET imaging of EGFR levels : pairing a targeting with a non-targeting Sel-tagged Affibody-based tracer to estimate the specific uptake
- 2016
-
Ingår i: EJNMMI Research. - : Springer. - 2191-219X. ; 6
-
Tidskriftsartikel (refereegranskat)abstract
- Background: Though overexpression of epidermal growth factor receptor (EGFR) in several forms of cancer is considered to be an important prognostic biomarker related to poor prognosis, clear correlations between biomarker assays and patient management have been difficult to establish. Here, we utilize a targeting directly followed by a non-targeting tracer-based positron emission tomography (PET) method to examine some of the aspects of determining specific EGFR binding in tumors. Methods: The EGFR-binding Affibody molecule Z(EGFR:2377) and its size-matched non-binding control Z(Taq:3638) were recombinantly fused with a C-terminal selenocysteine-containing Sel-tag (Z(EGFR:2377)-ST and Z(Taq:3638)-ST). The proteins were site-specifically labeled with DyLight488 for flow cytometry and ex vivo tissue analyses or with C-11 for in vivo PET studies. Kinetic scans with the C-11-labeled proteins were performed in healthy mice and in mice bearing xenografts from human FaDu (squamous cell carcinoma) and A431 (epidermoid carcinoma) cell lines. Changes in tracer uptake in A431 xenografts over time were also monitored, followed by ex vivo proximity ligation assays (PLA) of EGFR expressions. Results: Flow cytometry and ex vivo tissue analyses confirmed EGFR targeting by ZE(GFR:2377)-ST-DyLight488. [Methyl-C-11]-labeled Z(EGFR:2377)-ST-CH3 and Z(Taq:3638)-ST-CH3 showed similar distributions in vivo, except for notably higher concentrations of the former in particularly the liver and the blood. [Methyl-C-11]-Z(EGFR:2377)-ST-CH3 successfully visualized FaDu and A431 xenografts with moderate and high EGFR expression levels, respectively. However, in FaDu tumors, the non-specific uptake was large and sometimes equally large, illustrating the importance of proper controls. In the A431 group observed longitudinally, non-specific uptake remained at same level over the observation period. Specific uptake increased with tumor size, but changes varied widely over time in individual tumors. Total (membranous and cytoplasmic) EGFR in excised sections increased with tumor growth. There was no positive correlation between total EGFR and specific tracer uptake, which, since Z(EGFR:2377) binds extracellularly and is slowly internalized, indicates a discordance between available membranous and total EGFR expression levels. Conclusions: Same-day in vivo dual tracer imaging enabled by the Sel-tag technology and C-11-labeling provides a method to non-invasively monitor membrane-localized EGFR as well as factors affecting non-specific uptake of the PET ligand.
|
|
| 5. |
- Elander, Astrid, et al.
(författare)
-
Inhaler Technique and Self-reported Adherence to Medications Among Hospitalised People with Asthma and COPD
- 2020
-
Ingår i: Drugs - real world outcomes. - : Springer. - 2199-1154 .- 2198-9788. ; 7:4, s. 317-323
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Metered dose inhalers (MDIs) and dry powder inhalers (DPIs) are devices used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Inhaler technique is important since incorrect technique can lead to a poorer prognosis and hospitalization.OBJECTIVE: The objective of this study was to investigate the inhaler technique and overall adherence to medications in an adult population with asthma and COPD.PATIENTS AND METHODS: Those invited to participate were people admitted to Umeå University Hospital in northern Sweden in October, November and December 2018, with inhaled medication prescribed prior to admission. Inhaler technique was assessed using checklists and observations with placebo-inhalers were conducted. The Medication Adherence Report Scale (MARS)-5 was used to measure self-reported overall adherence to drug medication.RESULTS: Of the 23 people included in the study, 26.1% had one or more critical errors in inhaler technique and 30.4% were considered overall non-adherent to drug medication. Among the 23 participants, the mean age, and the number of regularly prescribed medications were higher among those with poor inhaler technique than among people with no error in their inhaler technique.CONCLUSION: This study indicates that poor inhaler technique and overall non-adherence to medications occur among hospitalised people with asthma and COPD living in northern Sweden. Interventions to improve inhaler technique and adherence to drugs are needed.
|
|
| 6. |
- Elander, Johanna, et al.
(författare)
-
Extended genetic diagnostics for children with profound sensorineural hearing loss by implementing massive parallel sequencing. Diagnostic outcome, family experience and clinical implementation
- 2022
-
Ingår i: International Journal of Pediatric Otorhinolaryngology. - : Elsevier BV. - 0165-5876. ; 159
-
Tidskriftsartikel (refereegranskat)abstract
- Objectives: The aim of this study was to investigate genetic outcomes, analyze the family experience, and describe the process of implementing genetic sequencing for children with profound sensorineural hearing loss (SNHL) at a tertial audiological center in southern Sweden. Design: This is a prospective pilot study including eleven children with profound bilateral SNHL who underwent cochlear implant surgery. Genetic diagnostic investigation was performed with whole exome sequencing (WES) complemented with XON-array to identify copy number variants, using a manually curated gene panel incorporating 179 genes associated with non-syndromic and syndromic SNHL. Mitochondrial DNA (mtDNA) from blood was examined separately. A patient reported experience measures (PREM) questionnaire was used to evaluate parental experience. We also describe here the process of implementing WES in an audiology department. Results: Six female and five male children (mean 3.4 years, SD 3.5 years), with profound bilateral SNHL were included. Genetic variants of interest were found in six subjects (55%), where three (27%) could be classified as pathogenic or likely pathogenic. Among the six cases, one child was found to have a homozygous pathogenic variant in MYO7A and two children had homozygous likely pathogenic variants in SLC26A4 and PCDH15, respectively. One was carrying a compound heterozygote frameshift variant of uncertain significance (VUS) on one allele and in trans, a likely pathogenic deletion on the other allele in PCDH15. Two subjects had homozygous VUS in PCDH15 and ADGRV1, respectively. In five of the cases the variants were in genes associated with Usher syndrome. For one of the likely pathogenic variants, the finding was related to Pendred syndrome. No mtDNA variants related to SNHL were found. The PREM questionnaire revealed that the families had difficulty in fully understanding the results of the genetic analysis. However, the parents of all eleven (100%) subjects still recommended that other families with children with SNHL should undergo genetic testing. Specifically addressed referrals for prompt complementary clinical examination and more individualized care were possible, based on the genetic results. Close clinical collaboration between different specialists, including physicians of audiology, audiologists, clinical geneticists, ophthalmologists, pediatricians, otoneurologists, physiotherapists and hearing habilitation teams was initiated during the implementation of the new regime. For all professionals involved, a better knowledge of the diversity of the genetic background of hearing loss was achieved. Conclusions: Whole exome sequencing and XON-array using a panel of genes associated with SNHL had a high diagnostic yield, added value to the families, and provided guidance for further examinations and habilitation for the child. Great care should be taken to thoroughly inform parents about the genetic test result. Collaborations between departments were intensified and knowledge of hearing genomics was increased among the staff.
|
|
| 7. |
- Elander, Johanna, et al.
(författare)
-
Pathogenic mtDNA variants, in particular single large-scale mtDNA deletions, are strongly associated with post-lingual onset sensorineural hearing loss in primary mitochondrial disease
- 2022
-
Ingår i: Molecular Genetics and Metabolism. - : Elsevier BV. - 1096-7192. ; 137:3, s. 230-238
-
Tidskriftsartikel (refereegranskat)abstract
- In this retrospective cohort study of 193 consecutive subjects with primary mitochondrial disease (PMD) seen at the Children's Hospital of Philadelphia Mitochondrial Medicine Frontier Program, we assessed prevalence, severity, and time of onset of sensorineural hearing loss (SNHL) for PMD cases with different genetic etiologies. Subjects were grouped by genetic diagnosis: mitochondrial DNA (mtDNA) pathogenic variants, single large-scale mtDNA deletions (SLSMD), or nuclear DNA (nDNA) pathogenic variants. SNHL was audiometrically confirmed in 27% of PMD subjects (20% in mtDNA pathogenic variants, 58% in SLSMD and 25% in nDNA pathogenic variants). SLSMD had the highest odds ratio for SNHL. SNHL onset was post-lingual in 79% of PMD cases, interestingly including all cases with mtDNA pathogenic variants and SLSMD, which was significantly different from PMD cases caused by nDNA pathogenic variants. SNHL onset during school age was predominant in this patient population. Regular audiologic assessment is important for PMD patients, and PMD of mtDNA etiology should be considered as a differential diagnosis in pediatric patients and young adults with post-lingual SNHL onset, particularly in the setting of multi-system clinical involvement. Pathogenic mtDNA variants and SLSMD are less likely etiologies in subjects with congenital, pre-lingual onset SNHL.
|
|
| 8. |
- Elander, Maria, et al.
(författare)
-
Avfallsindikatorer - Vägledning för hur man kan mäta och följa utvecklingen mot en resurseffektiv avfallshantering
- 2014
-
Rapport (övrigt vetenskapligt/konstnärligt)abstract
- Det finns idag ett stort behov av att kunna mäta och förstå hur resurseffektiv vår avfallshantering är, både på nationell nivå och i våra kommuner. Vi har successivt infört allt fler mål, styrmedel och åtgärder för att utveckla avfallshanteringen och stora förändringar har därigenom skett. Allt talar för att utvecklingen kommer att fortsätta i samma takt, potentialen att förbättra svensk avfallshantering är stor. Hur mäter vi om vi blir bättre? Hur effektiv är avfallshanteringen? Hur väl uppfyller vi de avfallspolitiska målen? Finns det skillnader i utvecklingen mellan olika kommuner och vilka slutsatser kan vi i så fall lära oss av det? Hur stor klimatpåverkan orsakar avfallsbehandlingen på de olika stegen i avfallshierarkin? Frågorna är många, men svaren är svåra att få fram. Trots förbättrad information och kunskap om avfallshanteringen har utmaningarna med att mäta och följa upp utvecklingen bara ökat. Inte minst eftersom man idag strävar efter att hantera så mycket av de de uppkomna avfallsmängderna på de övre stegen i avfallshierkin, det vill säga avfallsförebyggande, återanvändning och materialåtervinning. Dessa delar är betydligt svårare att beskriva, mäta och följa upp jämfört med de nedre behandlingsstegen. Denna vägledning är en av tre rapporter från ett projekt som har haft som syfte att ta fram mätetal, eller ""avfallsindikatorer"", som ska kunna mäta och följa utvecklingen för vår avfallshantering. Syftet är att avfallsindikatorerna årsvis ska presentera utvecklingen och därmed kunna ge svar på bland annat de frågor som nämns ovan. Avfallsindikatorerna presenteras mer utförligt i rapporten ""Indikatorer för en resurseffektiv avfallshantering"" som finns att ladda ner på Waste Refinerys hemsida. I rapporten kan man följa beräknings-metoderna, val av indata och hur projektgruppen resonerade om vilka indikatorer som behövs för att kunna mäta resurseffektivitet. På Waste Refinerys hemsida finns även en rapport innehållande en litteraturstudie över vilka indikatorer som idag används i Europa: Litteraturstudie över indikatorer för en resurseffektiv avfallshantering.
|
|
| 9. |
- Elander, Maria, et al.
(författare)
-
Impact assessment of policies promoting fiber-to-fiber recycling of textiles
- 2017
-
Rapport (övrigt vetenskapligt/konstnärligt)abstract
- As part of the Mistra Future Fashion Research Program, IVL Swedish Environmental Research Institute (IVL), the International Institute for Industrial Environmental Economics (IIIEE) and PlanMiljø have investigated policy options promoting (fiber-to-fiber) recycling of textile waste. The ambition was to contribute to and broaden the discussion regarding potential policy measures in the textile field as well as potential elements that can be included in such policies.Ten policy measures promoting fiber-to-fiber recycling of textiles, contributing to circular flows of textile waste, were identified and described. Two policy measures were selected for impact assessment: mandatory extended producer responsibility (EPR) and refunded virgin payments (RVP). The policy evaluation was carried out as an ex-ante assessment with regard to eight policy goals. Stakeholder views on the identified and assessed policy measures were collected in a policy workshop and via an online questionnaire. There is a potential to broaden the scope of policy measures promoting fiber-to-fiber recycling of textiles compared to the policy recommendations made by the Swedish Environmental Protection Agency (EPA). New policy measures in the textile field should embrace potentials to generate upstream improvements and increasing the demand for recycled textile fibers.Although the Swedish EPA suggests a mandatory EPR for textiles as one of two alternative policy options for handling of textile waste, the proposal focuses almost exclusively on downstream improvements. The mandatory EPR assessed in this report includes additional elements, embracing also the potential of an EPR system to generate upstream improvements. Economic instruments have shown to be successful measures to reduce environmental externalities. The RVP system assessed in this report adds a new perspective on potential ways and means to promote recycling of textiles complementing the investigation on how public bodies can contribute to more reuse and recycling of textiles by green public procurement suggested by the Swedish EPA.Both a mandatory EPR and a RVP system have potentials to have large positive impacts on fiber-to-fiber recycling as well as overall recycling of textiles. A mandatory EPR system has the same or larger positive impacts on all eight policy goals defined in this report compared to a RVP system. A mandatory EPR system embodies the potential to integrate a range (combination) of complementing policy measures whereas an RVP system should be complemented by additional policy measures.
|
|
| 10. |
- Elander, Maria, et al.
(författare)
-
Indikatorer för en resurseffektiv avfallshantering
- 2014
-
Rapport (övrigt vetenskapligt/konstnärligt)abstract
- Det övergripande målet med projektet var att ta fram ett antal indikatorer för att kunna visa på hur resurseffektiv avfallshanteringen är och jämföra hur utvecklingen blir över tiden. Detta innebär att indikatorerna: ska åskådliggöra måluppfyllelsen för uppsatta mål samt göra det möjligt att följa upp utvecklingen för svensk avfallshantering på kommunal/regional och nationell nivå på ett enkelt sätt . Trots att informationen och kunskapen om avfallshanteringen ständigt har förbättrats i samhället så har ändå svårigheterna med att mäta och följa upp utvecklingen ökat. De mål som satts för avfallshanteringen har stadigt förstärkts vilket har skapat ett alltmer komplext avfallshanteringssystem. Det märks tydligt på dagens ambitioner att utveckla de övre delarna i avfallshierarkin, det vill säga avfallsprevention och materialåtervinning. Dessa delar är betydligt svårare att beskriva, mäta och följa upp jämfört med de nedre behandlingsstegen. Att utveckla indikatorer kring förebyggande och frikoppling har varit ett viktigt mål för indikatorprojektet. I projektet har indikatorerna analyserats och testats i fem olika fallstudier (tre på kommunal nivå och två på nationell nivå varav en för hushållsavfall enligt Avfall Sverige och en för nationellt totalt avfall kopplat till den officiella avfallsstatistiken). Följande kriterier har använts och uppfylls: Relevans Datatillgång Kvalitet Kommunicerbarhet och användbarhet Indikatorerna som har tagits fram: Är neutrala och användbara på den nivå de avser, det vill säga på kommunal/ regional och/eller nationell nivå. Är utformade för att kunna mäta förändring och/eller förändringstakten årsvis Täcker varje steg av avfallshierarkin (det vill säga ge en indikation på resurseffektiviteten för respektive steg samt totalt). Mäter förändringen i resurseffektivitet för hela systemet över tid (det vill säga beskriva en position i avfallshierarkin). Indikatorerna kan användas på kommunal nivå eller på nationell nivå. Indikatorerna avser att ge beslutsfattare, kommuner och kommunala avfallsbolag stöd i planeringen och uppföljningen av den kommunala avfallshanteringen. Tre typer av indikatorer är utvecklade: Förflyttningsindikatorer – speglar avfallshanteringssystemets nivå och utveckling i sin helhet. Trappstegsindikatorer – beskriver och mäter utvecklingen på varje enskilt trappsteg i avfallshierarkin (avfallstrappan) minus de rejektmängder som uppkommer innan själva behandlingen (till exempel sorteringsrester från materialåtervinning). Bakgrundsindikatorer – tar hänsyn till allt avfall som behandlas på respektive trappsteg även avfall som uppkommer vid annan behandling (till exempel askor från förbränning). Indikatorerna presenteras samlat i Bilaga A. Målsättningen är att de framtagna indikatorerna ska integreras med existerande avfallsrapportering i kommunerna (till exempel i Avfall Web) och i den nationella uppföljningen som Naturvårdsverket genomför. En användarvägledning har också producerats inom projektet med syfte att ge en lättöverskådlig bild över indikatorerna och vad de kan användas till.
|
|
